10-Q

`

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2022

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________ to _______________

Commission File Number: 001-41201

CinCor Pharma, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware	36-4931245
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
230 Third Avenue, Waltham, MA 02451	02451
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (844) 531-1834

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.00001 par value per share	CINC	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☑

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 8, 2022, the registrant had 37,739,323 shares of common stock, $0.00001 par value per share, outstanding.

Table of Contents

		Page
PART I.	FINANCIAL INFORMATION
Item 1.	Condensed Financial Statements (Unaudited)	3
	Condensed Balance Sheets – June 30, 2022 (Unaudited) and December 31, 2021	3
	Condensed Statements of Operations – Three and Six Months Ended June 30, 2022 and 2021 (Unaudited)	4
	Condensed Statements of Comprehensive Loss - Three and Six Months Ended June 30, 2022 and 2021 (Unaudited)	5
	Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) – Three and Six Months Ended June 30, 2022 and 2021 (Unaudited)	6
	Condensed Statements of Cash Flows – Six Months Ended June 30, 2022 and 2021 (Unaudited)	7
	Condensed Notes to Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	28
Item 4.	Controls and Procedures	28
PART II.	OTHER INFORMATION	28
Item 1.	Legal Proceedings	28
Item 1A.	Risk Factors	28
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	29
Item 3.	Defaults Upon Senior Securities	29
Item 4.	Mine Safety Disclosures	29
Item 5.	Other Information	29
Item 6.	Exhibits	30
Signatures		31

SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q of CinCor Pharma, Inc., or CinCor or the Company, contains or incorporates statements that constitute forward-looking statements within the meaning of the federal securities laws. Any express or implied statements that do not relate to historical or current facts or matters are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of these terms or other comparable terminology.

Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These forward-looking statements include, without limitation, statements about the following:

•the timing, progress and results of our preclinical studies and clinical trials of baxdrostat (CIN-107) and any future product candidates, including statements regarding the timing of our planned IND submissions, initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

•our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

•the timing of any submission of filings for regulatory approval of, and our ability to obtain and maintain regulatory approvals for, baxdrostat and any future product candidates;

•our ability to identify patients with the diseases treated by our product candidate and to enroll these patients in our clinical trials;

•our expectations regarding the size of the patient populations, market acceptance and opportunity for and clinical utility of baxdrostat and any future product candidates, if approved for commercial use;

•business disruptions affecting the initiation, patient enrollment, development and operation of our clinical trials, including a public health emergency, such as the COVID-19 pandemic, or geopolitical events, including the ongoing military conflict between Russia and Ukraine, and related sanctions against Russia;

•macroeconomic events, including uncertain market conditions, higher inflation and supply chain disruptions;

•our expectations regarding the scope of any approved indication for baxdrostat or any future product candidate;

•our ability to successfully commercialize baxdrostat or any future product candidate, if approved;

•our expectations regarding the potential market size and the rate and degree of market acceptance for baxdrostat or any future product candidates that we develop;

•the effects of competition with respect to baxdrostat or any future product candidates, as well as innovations by current and future competitors in our industry;

•our ability to fund our working capital requirements;

•our intellectual property position, including the scope of protection we are able to establish, maintain and enforce for intellectual property rights covering baxdrostat;

•our financial performance and our ability to effectively manage our anticipated growth; and

•our ability to obtain additional funding for our operations.

You are urged to carefully review the disclosures we make concerning these risks and other factors that may affect our business and operating results under “Item 1A. Risk Factors” in the Annual Report on Form 10-K, as well as our other reports filed with the U.S. Securities and Exchange Commission ("SEC"). We may announce material business and financial

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information to our investors using our investor relations website (www.cincor.com/investor-relations). We therefore encourage investors and others interested in CinCor to review the information that we make available from time to time on our website, in addition to following our filings with the SEC, webcasts, press releases and conference calls. Any public statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this document. The Company does not intend, and undertakes no obligation, to update any forward-looking information to reflect events or circumstances after the date of this document or to reflect the occurrence of unanticipated events, unless required by law to do so.

TRADEMARKS, TRADENAMES AND SERVICE MARKS

This Quarterly Report on Form 10-Q includes trademarks, tradenames and service marks, certain of which belong to us and others that are the property of other organizations. Solely for convenience, trademarks, tradenames and service marks referred to in this Quarterly Report on Form 10-Q appear without the ®, ™ and SM symbols, but the absence of those symbols is not intended to indicate, in any way, that we will not assert our rights or that the applicable owner will not assert its rights to these trademarks, tradenames and service marks to the fullest extent under applicable law.

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PART I—FINANCIAL INFORMATION

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	June 30,			December 31,
	2022			2021
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	127,619,608		$	136,605,613
Marketable securities		166,692,295			—
Prepaid research and development contracts		7,482,503			1,769,074
Prepaid expense and other current assets		1,180,696			2,731,953
Total current assets		302,975,102			141,106,640
Long term assets:
Property and equipment, net		40,731			—
Total long term assets		40,731			—
Total assets	$	303,015,833		$	141,106,640
Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)
Current liabilities:
Accounts payable	$	2,095,374		$	642,143
Related-party accounts payable		—			7,323
Warrant derivative liabilities		—			10,636,921
Accrued legal expense		349,943			2,104,766
Accrued research and development contracts		3,230,997			1,751,530
Accrued expenses and other liabilities		1,605,560			1,406,506
Total current liabilities		7,281,874			16,549,189
Redeemable convertible preferred stock:
Series A redeemable convertible preferred stock,    $0.00001 par value, 0 and 35,714,282 shares authorized and    outstanding at June 30, 2022 and December 31, 2021, respectively		—			47,173,259
Series B redeemable convertible preferred stock,    $0.00001 par value, 0 and 35,716,249 shares authorized and    outstanding at June 30, 2022 and December 31, 2021, respectively		—			141,101,202
Stockholders’ equity (deficit):
Common stock, $0.00001 par value per share; 95,000,000 and 13,731,721 shares    authorized, and 37,709,912 and 2,557,341 outstanding at June 30, 2022 and    December 31, 2021, respectively		378			26
Additional paid-in capital		411,920,723			13,986,033
Accumulated deficit		(115,475,376	)		(77,703,069	)
Accumulated other comprehensive loss		(711,766	)		—
Total stockholders’ equity (deficit)		295,733,959			(63,717,010	)
Total liabilities, redeemable convertible preferred stock, and    stockholders’ equity (deficit)	$	303,015,833		$	141,106,640

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The accompanying notes are an integral part of these condensed financial statements.

CinCor Pharma, Inc.

Condensed Statements of Operations (Unaudited)

	Three Months Ended June 30,						Six Months Ended June 30,
	2022			2021			2022			2021
Operating expenses:
Research and development	$	17,161,014		$	3,998,391		$	26,851,612		$	7,487,821
General and administrative		4,191,767			1,176,018			8,205,513			2,099,583
Total operating expenses		21,352,781			5,174,409			35,057,125			9,587,404
Loss from operations		(21,352,781	)		(5,174,409	)		(35,057,125	)		(9,587,404	)
Other (income) expense:
Interest income		(277,377	)		(1,539	)		(328,825	)		(5,952	)
Change in fair value of warrant derivative liabilities		—			1,209,829			3,044,006			2,419,657
Total other (income) expense, net		(277,377	)		1,208,290			2,715,181			2,413,705
Net loss	$	(21,075,404	)	$	(6,382,699	)	$	(37,772,306	)	$	(12,001,109	)
Net loss per share attributable to common    stockholders, basic and diluted	$	(0.56	)	$	(4.81	)	$	(1.06	)	$	(9.31	)
Weighted average number of common shares used in    computing net loss per share attributable to common    stockholders, basic and diluted		37,709,912			1,327,852			35,583,567			1,289,141

The accompanying notes are an integral part of these condensed financial statements.

CinCor Pharma, Inc.

Condensed Statements of Comprehensive Loss (Unaudited)

	Three Months Ended June 30,						Six Months Ended June 30,
	2022			2021			2022			2021
Net loss	$	(21,075,404	)	$	(6,382,699	)	$	(37,772,306	)	$	(12,001,109	)
Other comprehensive loss:
Unrealized losses on available-for-sale securities		(394,155	)		—			(711,766	)		—
Comprehensive loss	$	(21,469,559	)	$	(6,382,699	)	$	(38,484,072	)	$	(12,001,109	)

The accompanying notes are an integral part of these condensed financial statements.

CinCor Pharma, Inc.

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) (unaudited)

Redeemable Convertible
Preferred Stock	Stockholders' Equity (Deficit)

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	Series A Redeemable Convertible Preferred Stock						Series B Redeemable Convertible Preferred Stock						Common Stock				Additional Paid-In		Accumulated			Accumulated Other Comprehensive			Total Stockholders' Equity
	Shares			Amount			Shares			Amount			Shares		Par Value		Capital		Deficit			Loss			(Deficit)
Balance at January 1, 2022		35,714,282		$	47,173,259			35,716,249		$	141,101,202			2,557,341	$	26	$	13,986,033	$	(77,703,069	)	$	—		$	(63,717,010	)
Issuance of common stock initial public offering, net of discounts and issuance costs of $19,420,580		—			—			—			—			13,290,813		133		193,550,593		—			—			193,550,726
Conversion of redeemable convertible preferred stock into common stock upon initial public offering		(35,714,282	)		(47,173,259	)		(35,716,249	)		(141,101,202	)		21,008,970		210		188,274,133		—			—			188,274,343
Automatic conversion of the Roche warrants into common stock upon initial public offering		—			—			—			—			852,788		9		13,644,599		—			—			13,644,608
Stock-based compensation expense		—			—			—			—			—		—		1,224,208		—			—			1,224,208
Other comprehensive loss		—			—			—			—			—		—		—		—			(317,611	)		(317,611	)
Net loss		—			—			—			—			—		—		—		(16,696,903	)					(16,696,903	)
Balance at March 31, 2022		—			—			—			—			37,709,912		378		410,679,566		(94,399,972	)		(317,611	)		315,962,361
Stock-based compensation expense		—			—			—			—			—		—		1,241,157		—			—			1,241,157
Other comprehensive loss		—			—			—			—			—		—		—		—			(394,155	)		(394,155	)
Net loss		—			—			—			—			—		—		—		(21,075,404	)		—			(21,075,404	)
Balance at June 30, 2022		—			—			—			—			37,709,912		378		411,920,723		(115,475,376	)		(711,766	)		295,733,959
	Redeemable Convertible
	Preferred Stock												Stockholders' Deficit
	Series A Redeemable Convertible Preferred Stock						Series B Redeemable Convertible Preferred Stock						Common Stock				Additional Paid-In		Accumulated			Accumulated Other Comprehensive			Total Stockholders'
	Shares			Amount			Shares			Amount			Shares		Par Value		Capital		Deficit			Loss			Equity (Deficit)
Balance at January 1, 2021		35,714,282		$	47,173,259			—		$	—			1,250,000	$	13	$	69,330	$	(27,333,995	)	$	—		$	(27,264,652	)
Stock-based compensation expense		—			—			—			—			—		—		1,389,955		—			—			1,389,955
Net loss		—			—			—			—			—		—		—		(5,618,411	)		—			(5,618,411	)
Balance at March 31, 2021		35,714,282			47,173,259			—			—			1,250,000		13		1,459,285		(32,952,406	)		—			(31,493,108	)
Stock options exercised		—			—			—			—			142,636		1		1,232,799		—			—			1,232,800
Stock-based compensation expense		—			—			—			—			—		—		293,849		—			—			293,849

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Net loss	—	—	—	—	—	—	—	(6,382,699	)		(6,382,699	)
Balance at June 30, 2021	35,714,282	47,173,259	—	—	1,392,636	14	2,985,933	(39,335,105	)	—	(36,349,158	)

The accompanying notes are an integral part of these condensed financial statements.

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CinCor Pharma, Inc.

Condensed Statements of Cash Flows (Unaudited)

	For the Six Months ended June 30,
	2022			2021
Operating activities:
Net loss	$	(37,772,306	)	$	(12,001,109	)
Adjustments to reconcile net loss to net    cash used in operating activities:
Stock-based compensation expense		2,465,365			1,802,906
Change in fair value of warrant derivative liabilities		3,044,006			2,419,657
Accretion of discount on available-for-sale securities		(178,383	)		-
Depreciation		1,405			-
Changes in operating assets and liabilities:
Prepaid research and development contracts		(5,713,429	)		(2,042,900	)
Prepaid expenses and other current assets		(1,074,117	)		(236,041	)
Accounts payable		1,416,124			(2,379,671	)
Related-party accounts payable		(7,323	)		36,354
Accrued expenses and other liabilities		552,364			(1,181,459	)
Net cash used in operating activities		(37,266,294	)		(13,582,263	)
Investing activities:
Purchases of marketable securities		(227,225,678	)		—
Maturities of marketable securities		60,000,000			—
Purchase of property and equipment		(42,136	)		—
Net cash used in investing activities		(167,267,814	)		—
Financing activities:
Proceeds from issuance of common stock		197,767,310			—
Issuance costs in initial public offering		(2,219,207	)		—
Proceeds from stock option exercise		—			1,232,799
Net cash provided by financing activities		195,548,103			1,232,799
Net decrease in cash and cash equivalents		(8,986,005	)		(12,349,464	)
Cash and cash equivalents at beginning of period		136,605,613			26,078,064
Cash and cash equivalents, at end of period(1)	$	127,619,608		$	13,728,600
Supplemental disclosures for non-cash financing activities
Conversion of redeemable convertible preferred stock into common stock upon initial public offering	$	188,274,133		$	—
Automatic conversion of the Roche warrants into common stock upon initial public offering		13,644,608			—
(1) Cash and cash equivalents excludes marketable securities of $166.7 million. Cash, cash equivalents and marketable securities at June 30, 2022, was $294.3 million.

The accompanying notes are an integral part of these condensed financial statements.

CinCor Pharma, Inc.

Condensed Notes to Financial Statements

(Unaudited)

1. Nature of Organization and Operations

CinCor Pharma, Inc. (the “Company”) is a clinical-stage biopharmaceutical company focused on developing its lead clinical candidate, baxdrostat, for the treatment of hypertension and other cardio-renal diseases. Baxdrostat is a highly selective, oral small molecule inhibitor of aldosterone synthase, the enzyme responsible for the synthesis of aldosterone in the adrenal gland. The Company is conducting multiple Phase 2 clinical trials using baxdrostat in differing populations of patients, all of whom are hypertensive.

The Company was incorporated in March 2018 and founded as a subsidiary of CinRx Pharma, LLC (“CinRx”), a biotechnology company focused on developing novel therapeutics. In May 2019, the Company entered into an agreement with F. Hoffmann-La Roche Ltd and Hoffmann La-Roche Inc. (collectively, “Roche”) for an exclusive, worldwide, royalty-bearing license to certain Roche technology to

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research, develop, manufacture, and commercialize a novel aldosterone synthase inhibitor compound, baxdrostat, for any and all diseases and conditions. In connection with the in-licensing transaction with Roche, the Company was spun out as an independent company.

The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, possible failure of preclinical studies or clinical trials, the need to obtain marketing approval for its product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, the need to successfully commercialize and gain market acceptance of any of the Company’s products that are approved and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing, and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.

Initial Public Offering and Liquidity

On January 11, 2022, the Company completed an initial public offering (the "IPO") of its common stock pursuant to which the Company issued and sold 13,290,813 shares of common stock at a price to the public of $16.00 per share. The aggregate net proceeds from the IPO were approximately $193.6 million after deducting underwriting discounts and commissions of $14.9 million and offering expenses of approximately $4.5 million. Upon completion of the IPO, all outstanding shares of Series A and Series B redeemable convertible preferred stock converted to 21,008,970 shares of common stock at a ratio of 3.4:1. In addition, the IPO also resulted in the automatic net exercise of the three outstanding warrants to purchase common stock issued to Roche for an aggregate of 852,788 shares of common stock (collectively, the “Roche Warrants”).

The Company incurred significant losses from operations and had negative cash flows from operating activities for the three and six months ended June 30, 2022 and 2021, and since inception. The Company’s current operating plan indicates it will continue to incur losses from operations and generate negative cash flows from operating activities, given ongoing expenditures related to extensive research and development and the Company’s lack of revenue-generating activities at this point in the Company’s life cycle.

The Company expects that its existing cash, cash equivalents and marketable securities is sufficient to fund its operating expenses and capital expenditure requirements through 2024, including completing all of its ongoing Phase 2 trials, its currently planned Phase 3 clinical program in hypertension, CMC development and GMP batch production, and the additional activities needed to complete its planned new drug application submission. The future viability of the Company beyond that point is dependent on its ability to raise additional capital to fund its operations.

If the Company is unable to obtain future funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations.

2. Summary of Significant Accounting Policies

Basis of Presentation

The unaudited condensed financial statements have been prepared in accordance with U.S. Securities and Exchange Commission (“SEC”) regulations and include all of the information and disclosures required by U.S. generally accepted accounting principles (“U.S. GAAP” or “GAAP”) for interim financial reporting, and, in the opinion of management include all adjustments necessary for a fair presentation of the condensed financial statements for each period presented. All adjustments are normal and recurring in nature. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). These unaudited condensed financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2021 in the Company’s Annual Report on Form 10-K filed with the SEC on March 22, 2022. The results of operations for the interim periods are not necessarily indicative of results of operations for a full year. The Company’s condensed financial statements are stated in U.S. Dollars.

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment. All the assets and operations of the Company’s sole operating segment are located in the United States.

Use of Estimates

The preparation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the

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condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls and in developing the estimates and assumptions that are used in the preparation of these condensed financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates have been or are used in the following areas, among others: prepaid research and development contracts, fair value of the Company's common stock prior to the IPO, fair value of warrant derivative liabilities, stock compensation expense and income taxes.

Prior to its IPO, the Company utilized estimates and assumptions in determining the fair value of its common stock. The Company has granted stock options at exercise prices that represented the fair value of its common stock on grant date. The Company utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation, to estimate the fair value of its common stock prior to its IPO. Each valuation methodology includes estimates and assumptions that require the Company's judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of redeemable convertible preferred stock, the superior rights and preferences of the redeemable convertible preferred stock senior to the Company's common stock at the time, and a probability analysis of various liquidity events at that time, such as a public offering or sale of the Company, under differing scenarios. Changes to the key assumptions used in the valuations could have resulted in different fair values of common stock at each valuation date.

The Company's results and business operations can also be affected or disrupted by economic, political, legislative, health concerns, such as the COVID-19 pandemic, regulatory, legal actions and geopolitical events, such as the ongoing military conflict between Ukraine and Russia and the related sanctions against Russia. Economic conditions, such as recessionary trends, inflation, interest, changes in regulatory laws and monetary exchange rates, and government fiscal policies, can also have a significant effect on operations. In addition, the conflict between Russia and Ukraine and related sanctions has had significant ramifications on global financial markets, including volatility in the U.S. and global financial markets, which has led to disruptions to trade, commerce, pricing stability, credit availability, supply chain continuity and reduced access to liquidity globally, and has caused and may continue to cause volatility in the price of our common stock, which may adversely impact our ability to raise capital on favorable terms or at all. The full economic and social impact of the sanctions imposed on Russia and possible future punitive measures that may be implemented, as well as the counter measures imposed by Russia, in addition to the ongoing military conflict between Ukraine and Russia remains uncertain; however, both the conflict and related sanctions have resulted and could continue to result in disruptions to trade, commerce, pricing stability, credit availability, supply chain continuity and reduced access to liquidity on acceptable terms, in both Europe and globally, and has introduced significant uncertainty into global markets. As a result, our business and results of operations may be adversely affected by the ongoing conflict between Ukraine and Russia and related sanctions, particularly to the extent it escalates to involve additional countries, further economic sanctions or wider military conflict. While the Company maintains reserves for anticipated liabilities, the Company could be affected by civil, criminal, regulatory, or administrative actions, claims, or proceedings. The extent to which the Company’s business can be impacted by future events is highly uncertain and cannot be predicted at this time.

Concentration of Credit Risk and Other Risks and Uncertainties

The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements. Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash and cash equivalents, which consist of money market funds that invest primarily in short­ term U.S. government securities and short-term marketable securities that are primarily invested in fixed income securities.

The Company has not yet generated any revenue from the sale of its products and is subject to all of the risks and uncertainties that are typically faced by biopharmaceutical companies that devote substantially all of their efforts to research and development and clinical trials and do not yet have commercial products. The Company expects to continue incurring losses for the foreseeable future.

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include cash held in banks and amounts held primarily in interest-bearing money market accounts. Cash equivalents are carried at cost, which approximates their fair market value.

Marketable Securities

The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each condensed balance sheet date. The Company classified all of its marketable securities at December 31, 2021 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value with the unrealized gains and losses included in other comprehensive loss as a component of stockholders’ equity (deficit) until realized. Any premium or discount arising at purchase is amortized or accreted to interest income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are

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included in other (income) expense, net. There were no material realized gains or losses on marketable securities recognized for the three and six months ended June 30, 2022 or 2021.

Initial Public Offering Costs

Costs directly attributable to the Company’s IPO which were incurred in 2021 were deferred and capitalized as prepaid expenses and other current assets at December 31, 2021. These costs primarily represented legal, underwriting and accounting costs related to the Company’s efforts to raise capital through a public sale of its common stock. Any additional costs incurred during the six months ended June 30, 2022 were deferred until the completion of the IPO, which occurred on January 11, 2022, at which time they were reclassified to additional paid in capital as a reduction of the IPO gross proceeds. At December 31, 2021, the Company had capitalized $2.6 million of deferred IPO costs, as prepaid expenses and other current assets. A total of $4.5 million of IPO issuance costs were incurred through January 11, 2022, which were recorded as a reduction of the IPO gross proceeds and included the $2.6 million previously capitalized in 2021.

Redeemable Convertible Preferred Stock

In accordance with ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480”), preferred stock issued with redemption provisions that are outside of the control of the issuer or that contain certain redemption features in a Deemed Liquidation Event (as defined in our Amended and Restated Certificate of Incorporation) is required to be presented outside of stockholders' equity (deficit) on the face of the condensed balance sheet and certain disclosures are required to be included in the notes to the condensed financial statements. If required, changes in fair value are recorded as additional paid in capital and/or accumulated deficit in the condensed balance sheets. Changes in fair value that would reduce the fair value of the redeemable convertible preferred stock below the original issue price are limited so that the value of the shares are not recorded below the original issue price.

Fair Value Measurements

Financial assets and liabilities are recorded at fair value. The carrying amount of certain financial instruments, including accounts payable and other current liabilities approximate fair value due to their relatively short maturities. Assets and liabilities recorded at fair value on a recurring basis in the condensed balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:

Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;

Level 2—Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and

Level 3—Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data.

Where quoted prices are available in an active market, assets or liabilities are classified as Level 1.

To the extent that a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument's level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. There were no transfers within the fair value hierarchy in 2022 and 2021.

Research and Development

The Company charges all research and development costs, both internal and external, to expense when incurred. Costs are considered incurred based on an evaluation of the progress to completion of specific tasks under each contract using information and data provided to the Company by its clinical sites and vendors. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company. The Company's research and development expenses consist primarily of clinical trial expenses, consulting costs and stock-based compensation, and costs associated with required regulatory filings, licenses, and fees.

Stock-Based Compensation

The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718, Compensation – Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, including grants of employee stock options and restricted stock units, to be recognized in the statements of operations based on their fair values. The Company’s stock-based awards are subject only to service-based vesting conditions. The Company estimates the fair value of its stock-based awards in the form of employee stock options, using the Black-Scholes option pricing model, which requires the input of assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends.

Prior to its IPO, the Company had based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The computation of expected volatility is based on the historical volatility of a representative group of companies

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with similar characteristics to the Company, including stage of product development and life science industry focus. The Company believes the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of the Company.

The Company uses the simplified method as prescribed by the SEC Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term for options granted to employees and utilizes the contractual term for options granted to non-employees. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of the stock options.

Compensation expense related to awards to employees is calculated on a straight-line basis by recognizing the grant date fair value over the associated service period of the award, which is generally the vesting term.

Derivative Instruments, Including Warrant Derivative Liabilities

The Company accounts for derivatives, specifically freestanding detachable stock purchase warrants, in accordance with ASC Topic 815, Derivatives and Hedging ("ASC 815"). This guidance establishes accounting and reporting principles for derivative instruments, including certain derivative instruments embedded in other contracts.

Net Loss Per Share

The Company's basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share attributable to common stockholders is computed by giving effect to all potential common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, redeemable convertible preferred stock prior to the Company's IPO and stock options to purchase common stock are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share attributable to common stockholders as their effect is anti-dilutive.

Income Taxes

Income taxes are recorded in accordance with ASC Topic 740, Income Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the condensed financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the condensed financial statement and tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates anticipated to be in effect for the year in which the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all the deferred tax assets will not be realized.

The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that some or all the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. As of June 30, 2022, and December 31, 2021, the Company does not have any significant uncertain tax positions. If the Company were to incur interest and penalties on uncertain tax positions, it would classify them as income tax expense.

The Company files U.S. federal and state income tax returns.

The Company did not record a current or deferred income tax expense or benefit for the three and six months ended June 30, 2022 and 2021, due to the Company’s net and comprehensive losses and increases in its deferred tax asset valuation allowance.

Comprehensive Loss

Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. For the three and six months ended June 30, 2022, the Company’s only element of other comprehensive loss was unrealized losses on available-for-sale securities. Comprehensive loss for the three and six months ended June 30, 2021, equaled net loss for those periods.

Litigation and Other Contingencies

The Company may be subject to legal proceedings and claims arising from the ordinary course of its business, including contract and employment claims. U.S. GAAP requires that a liability for contingencies be recorded when it is probable that a liability has occurred, and the amount of the liability can be reasonably estimated. In the opinion of management, the aggregate liability, if any, with respect to such ordinary course of business actions will not have a material adverse effect on the financial position or results of operations of the Company.

Reverse Stock Split

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On December 30, 2021, the Company’s Board of Directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 3.4-for-1 reverse stock split of the Company’s common stock, which was effected on December 30, 2021. Stockholders entitled to fractional shares as a result of the reverse stock split received a cash payment in lieu of receiving fractional shares. The par value of the common stock was not adjusted as a result of the reverse stock split. Shares of common stock underlying outstanding stock options and other equity instruments were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the appropriate securities agreements. Shares of common stock reserved for issuance upon the conversion of our convertible preferred stock were proportionately reduced and the respective conversion prices were proportionately increased. All common share and per share data have been retrospectively revised including the three and six months ended June 30, 2021, to reflect the reverse stock split.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

3. Fair Value of Measurements

The following table represents the financial instruments measured at fair value on a recurring basis based on the fair value hierarchy at:

	June 30, 2022
	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	127,619,608	$	—	$	—	$	127,619,608
Marketable securities:
US Treasury bills		74,612,727		—		—		74,612,727
Certificate of deposit		42,587,053		—		—		42,587,053
US Government agency securities		—		49,492,515		—		49,492,515
Total assets at fair value	$	244,819,388	$	49,492,515	$	—	$	294,311,903
	December 31, 2021
	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	136,605,613	$	—	$	—	$	136,605,613
Total assets at fair value	$	136,605,613	$	—	$	—	$	136,605,613
Liabilities:
Warrant derivative liabilities	$	—	$	—	$	10,636,921	$	10,636,921
Total liabilities at fair value	$	—	$	—	$	10,636,921	$	10,636,921

The amortized cost basis of marketable securities as of June 30, 2022 was $182.4 million.

The fair value of money market funds, U.S. Treasury bills and certificates of deposits are based on unaudited quoted market prices, which are considered Level 1 inputs in the fair value hierarchy. Level 2 assets consists of U.S. Government agency securities and are based upon quoted market prices for similar securities in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third-party data providers, including but not limited to, benchmark yields, interest rate curves, reported trades, broker/dealer quotes and reference data.

The following table sets forth a summary of changes in the fair value of the warrant derivative liabilities, representing a recurring measurement that is classified within Level 3 of the fair value hierarchy:

January 1, 2022	$	10,636,921
Change in fair value of warrant derivative liabilities		3,044,006
Automatic conversion of Roche warrants into common stock upon initial public offering		(13,680,927	)
June 30, 2022	$	-

The Company estimated the fair value of the warrant derivative liabilities using a Black-Scholes option pricing model. The valuation model used the following assumptions at December 31, 2021:

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	December 31,
	2021
Fair value of common stock	$	12.44
Volatility		64.00	%
Expected term (in years)		0.52
Risk-free interest rate		0.21	%
Dividend yield		—

The preceding methods described may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Furthermore, although the Company believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value could result in a different fair value measurement at the reporting date.

4. License Agreement

In May 2019, the Company entered into a license agreement (“Roche Agreement”) with Roche, pursuant to which the Company obtained an exclusive, worldwide, royalty-bearing license under certain patents and specified know-how owned or controlled by Roche and covering certain specified small molecule aldosterone synthase inhibitors (“Roche Technology”) to research, develop and commercialize products containing such aldosterone synthase inhibitors (“Licensed Products”) for any and all uses, including the treatment, prevention or diagnosis of any and all diseases and medical conditions in humans and animals. Pursuant to the Roche Agreement, the Company paid Roche a one-time, upfront non-refundable license fee of $2.0 million. Additionally, the Company is required to pay Roche certain regulatory event-based milestone payments, certain one time sales-based milestone payments, as well as tiered royalty payments based on the net sales of the Licensed products.

The Roche Agreement will expire, unless earlier terminated by either party, upon expiration of all royalty or other payment obligations under the Roche Agreement are or will become due. For the three months ended June 30, 2022 and 2021, the Company recorded non-cash expense of $0.0 million and $1.2 million, respectively and $3.0 million and $2.4 million, for the six months ended June 30, 2022 and 2021, respectively, related to the Roche Agreement on the Company’s condensed statements of operations.

5. Redeemable Convertible Preferred Stock

Series A Redeemable Convertible Preferred Stock

In May 2019, the Company authorized the issuance of 35,714,282 shares to be issued in the form of Series A redeemable convertible preferred stock (“Series A preferred stock”). The Company issued 35,714,282 shares of Series A preferred stock at $1.40 per share for total proceeds of $50 million. The Company incurred $2.1 million of Series A preferred stock issuance costs, which was recorded against the carrying amount of the Series A preferred stock as of December 31, 2021. The rights, preferences, and privileges of the Company’s Series A preferred stock prior to IPO were as follows:

Voting

Up until the IPO, the holders of Series A preferred stock were entitled to a number of votes equal to the number of whole shares of common stock into which the shares of Series A preferred stock were convertible. Except as provided by law or otherwise, the holders of the Series A preferred stock vote together with the holders of common stock as a single class.

Up until the IPO, the holders of Series A preferred stock, voting as a separate class, were entitled to elect three members of the Board of Directors. The holders of the common stock, voting as a separate class, were entitled to elect two members of the Board of Directors. The holders of Series A preferred stock and common stock, voting together as a single class on an as-converted basis, are entitled to elect any additional members of the Board of Directors.

Dividends

Dividends were payable, if permitted by law, in accordance with the Series A preferred stock terms if and when declared by the Board of Directors. Holders of the Series A preferred stock were entitled to receive dividends out of any assets at the time legally available, at the applicable dividend rate specified for such shares of the Series A preferred stock. Dividends were not mandatory and were not cumulative. No dividends were declared or paid since inception of the Company.

Liquidation

In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holders of shares of the Series A preferred stock then outstanding were entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a Deemed Liquidation Event, out of the consideration payable to stockholders in such an event, before any payment shall be made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the Series A preferred

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stock original issue price, plus any dividends declared but unpaid. If upon any such liquidation, dissolution, or winding up of the Company or a Deemed Liquidation Event, the assets of the Company available for distribution to its stockholders are insufficient to pay the holders of shares of Series A preferred stock the full amount to which they were entitled, the holders of shares of the Series A preferred stock share ratably in any distribution of the assets available for distribution in proportion to the respective amounts that would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

The remaining available proceeds would be distributed pro rata among the holders of the shares of the Series A preferred stock and common stock, based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted to common stock pursuant to the applicable terms immediately prior to such liquidation, dissolution, or winding up of the Company.

Conversion

Each share of the Series A preferred stock was convertible, at the option of the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of common stock as determined by dividing the Series A preferred stock original issue price by the Series A preferred stock conversion price in effect at the time of conversion. The applicable conversion price was subject to future adjustments upon the occurrence of certain events. However, holders of the Series A preferred stock did not have the right to convert any shares of the Series A preferred stock at the applicable conversion ratio in effect for preferred shares upon either (i) the closing of a qualified initial public offering of its common stock at a price per share of at least $14.28 per share (subject to adjustment for any share split, combination or dividend or distribution payable) resulting in at least $50 million in gross proceeds to the Company net of the underwriting discount and commissions, or (ii) the election to convert the preferred shares by at least two of the following three holders of the Company’s Series A preferred stock: (i) Sofinnova Venture Partners X, L.P., (ii) Sofinnova Capital IX and (iii) 5AM Ventures VI, L.P.

The Company evaluated the Series A preferred stock and determined that it was considered an equity host under ASC 815. In making this determination, the Company’s analysis followed the whole instrument approach, which compares an individual feature against the entire Series A preferred stock instrument that includes that feature. The Company’s analysis was based on a consideration of the economic characteristics and risks of the Series A preferred stock. More specifically, the Company evaluated all of the stated and implied substantive terms and features, including (i) whether the Series A preferred stock included redemption features, (ii) how and when any redemption features could be exercised, (iii) whether the holders of the Series A preferred stock were entitled to dividends, (iv) the voting rights of the Series A preferred stock, and (v) the existence and nature of any conversion rights. The Company concluded that, as the Series A preferred stock represents an equity host, the conversion feature included in the Series A preferred stock is clearly and closely related to the associated host instrument. Accordingly, the conversion feature is not considered an embedded derivative that requires bifurcation.

The Company accounts for potentially beneficial conversion features under ASC Topic 470-20, Debt with Conversion and Other Options ("ASC 470-20"). At the time of the issuances of the shares of Series A preferred stock, the Company’s common stock into which the Company’s Series A preferred stock was convertible had an estimated fair value less than the effective conversion prices of the shares of Series A preferred stock. Therefore, there was no beneficial conversion element on the issuance dates.

On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the Series A preferred stock was converted into 10,504,199 shares of the Company’s common stock.

Redemption

The holders of the Company’s redeemable convertible preferred stock have no rights to cause the redemption of their shares outside of a Deemed Liquidation Event. A Deemed Liquidation Event would constitute a redemption event that may be outside of the Company’s control.

Any redemption was deemed to be remote at December 31, 2021, and the fair value of Series A preferred stock was deemed to be the price paid by the Series A preferred stockholders.

Due to this redemption option, Series A preferred stock is recorded in mezzanine equity and is subject to subsequent measurement under the guidance provided under ASC 480. In accordance with that guidance, the Company has elected to recognize changes in redemption value immediately.

Warrant Derivative Liabilities

In connection with the Series A preferred stock financing, the Company issued two freestanding detachable stock purchase warrants to an unrelated third party to separately purchase 411,765 and 329,552 shares of common stock (“2019 Warrants”). The 2019 Warrants were exercisable in whole immediately prior to an initial public offering by the Company and, as such, remain issued, outstanding, and exercisable at December 31, 2021. The 2019 Warrants were issued with an initial exercise price of $0.04 and an expiration date of May 13, 2029. The 2019 Warrants qualify as derivative liabilities, which must be accounted for separately from the Series A preferred stock and are measured at fair value on a recurring basis. At December 31, 2021, the 2019 Warrants were valued at $9.2 million, with the change in fair value included in the condensed statements of operations in the period the change occured.

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On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the 2019 Warrants were converted into 739,463 shares of the Company’s common stock and are no longer outstanding.

Series B Redeemable Convertible Preferred Stock

In September 2021, the Company authorized the issuance of 35,716,249 shares to be issued in the form of Series B redeemable convertible preferred stock ("Series B preferred stock"). The Company issued 35,716,249 shares of Series B preferred stock at $4.00 per share for total proceeds of $142.9 million. The Company incurred $0.9 million of Series B preferred stock issuance costs which were recorded against the carrying amount of the Series B preferred stock at December 31, 2021. The rights, preferences, and privileges of the Company’s Series B preferred stock prior to the IPO were as follows:

Voting

Up until the IPO, the holders of Series B preferred stock were entitled to a number of votes equal to the number of whole shares of common stock into which the shares of Series B preferred stock were convertible. Except as provided by law or otherwise, the holders of the Series B preferred stock vote together with the holders of common stock as a single class.

Up until the IPO, holders of Series B preferred stock, voting as a separate class, were entitled to elect one member of the Board of Directors. The holders of preferred stock and common stock, voting together as a single class on an as-converted basis, were entitled to elect any additional members of the Board of Directors other than directors elected by the holders of Series A preferred stock and directors elected by holders of the common stock.

Dividends

Dividends at the rate per annum of $0.32 per share accrued on shares of Series B preferred stock. Dividends on the shares of Series B preferred stock were not cumulative and were payable, if and when declared by the Board of Directors. The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company unless the holders of preferred stock then outstanding first or simultaneously receive a dividend on each outstanding share of redeemable convertible preferred stock in an amount at least equal to the sum of (i) the amount of the aggregate dividends accrued but unpaid on such shares of preferred stock and (ii) that dividend per share of preferred stock as would equal the product of (1) the dividend payable on each share of such class or series determined, if applicable, as if all shares of such class or series had been converted into common stock and (2) the number of shares of common stock issuable upon conversion of a share of preferred stock. No dividends were declared or paid since inception of the Company.

Liquidation

In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holders of shares of the Series B preferred stock then outstanding were entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a Deemed Liquidation Event, out of the consideration payable to stockholders in such an event, before any payment shall be made to the holders of Series A preferred stock or common stock by reason of their ownership thereof, an amount per share equal to the Series B preferred stock original issue price, plus any dividends declared but unpaid thereon. If upon any such liquidation, dissolution, or winding up of the Company or a Deemed Liquidation Event, the assets of the Company available for distribution to its stockholders are insufficient to pay the holders of shares of Series B preferred stock the full amount to which they were entitled, the holders of shares of the Series B preferred stock shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts that would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

In the event that the assets of the Company available for distribution exceeded the amount necessary to pay the holders of Series B preferred stock, the holders of shares of Series A preferred stock then outstanding were entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a Deemed Liquidation Event, out of the consideration payable to stockholders in such an event, before any payment shall be made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the Series A preferred stock original issue price, plus any dividends declared but unpaid thereon. If upon any such liquidation, dissolution, or winding up of the Company or a Deemed Liquidation Event, the assets of the Company available for distribution to its stockholders were insufficient to pay the holders of shares of Series A preferred stock the full amount to which they were entitled, the holders of shares of the Series A preferred stock shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts that would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

The remaining available proceeds would have been distributed pro rata among the holders of the shares of the Series B preferred stock, Series A preferred stock and common stock, based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted to common stock pursuant to the applicable terms immediately prior to such liquidation, dissolution, or winding up of the Company.

Conversion

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Each share of the Series B preferred stock was convertible, at the option of the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of common stock as determined by dividing the Series B preferred stock original issue price by the Series B preferred stock conversion price in effect at the time of conversion. The Series B preferred stock conversion price shall initially be equal to the Series B original issue price. The applicable conversion price is subject to future adjustments upon the occurrence of certain events. Upon either (i) the closing of a qualified initial public offering of the Company’s common stock resulting in at least $100 million in proceeds net of the underwriting discount and commissions; (ii) the closing of a transaction or series of transactions in which the Company’s outstanding shares of capital stock are exchanged for or converted into securities that are publicly listed on a securities exchange through a merger, acquisition, business combination or similar transaction with a “special purpose acquisition company” where the surviving or parent entity receives aggregate gross proceeds, excluding the cash resources of the Company, of at least $100 million; or (iii) the date and time, or the occurrence of an event, specified by vote or written consent of the requisite holders and the Series B requisite holders, then all outstanding shares of preferred stock shall automatically be converted into shares of common stock at the effective conversion rate.

The Company evaluated the Series B preferred stock and determined that it was considered an equity host under ASC 815. In making this determination, the Company’s analysis followed the whole instrument approach, which compares an individual feature against the entire Series B preferred stock instrument that includes that feature. The Company’s analysis was based on a consideration of the economic characteristics and risks of the Series B preferred stock. More specifically, the Company evaluated all of the stated and implied substantive terms and features, including (i) whether the Series B preferred stock included redemption features, (ii) how and when any redemption features could be exercised, (iii) whether the holders of the Series B preferred stock were entitled to dividends, (iv) the voting rights of the Series B preferred stock, and (v) the existence and nature of any conversion rights. The Company concluded that, as the Series B preferred stock represents an equity host, the conversion feature included in the Series B preferred stock is clearly and closely related to the associated host instrument. Accordingly, the conversion feature is not considered an embedded derivative that requires bifurcation.

The Company accounts for potentially beneficial conversion features under ASC 470-20. At the time of the issuances of the shares of Series B preferred stock, the Company’s common stock into which the Company’s Series B preferred stock was convertible had an estimated fair value less than the effective conversion prices of the shares of Series B preferred stock. Therefore, there was no beneficial conversion element on the issuance dates.

On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the Series B preferred stock was converted into 10,504,779 shares of the Company’s common stock.

Redemption

The holders of the Company’s redeemable convertible preferred stock had no rights to cause the redemption of their shares outside of a Deemed Liquidation Event. A Deemed Liquidation Event would constitute a redemption event that may be outside of the Company’s control.

Any redemption was deemed to be remote at December 31, 2021, and the fair value of Series B preferred stock was deemed to be the price paid by the Series B preferred stockholders.

Due to this redemption option, Series B preferred stock was recorded in mezzanine equity and is subject to subsequent measurement under the guidance provided under ASC 480. In accordance with that guidance, the Company elected to recognize changes in redemption value immediately.

Warrant Derivative Liabilities

In connection with the Series B preferred stock, the Company issued freestanding detachable stock purchase warrants to an unrelated third party to separately purchase 113,610 shares of common stock ("2021 Warrants"). The 2021 Warrants were exercisable in whole immediately prior to an initial public offering by the Company and, as such, remained issued, outstanding, and exercisable at December 31, 2021. The 2021 Warrants were issued with an initial exercise price of $0.01 and an expiration date of May 13, 2029. The 2021 Warrants qualified as derivative liabilities, which must be accounted for separately from the Series B preferred stock and are measured at fair value on a recurring basis. At December 31, 2021, the 2021 Warrants were valued at $1.4 million with the change in fair value from the date of issuance included in the condensed statements of operations in the period the change occured.

On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the 2021 Warrants were converted into 113,325 shares of the Company’s common stock.

6. Stockholders’ Equity (Deficit) and Stock-Based Compensation

Stock Options

On December 30, 2021, the Board of Directors adopted, and the Company’s stockholders approved, the 2022 Equity Incentive Plan (“2022 Plan”). The 2022 Plan provides for the grant of incentive stock options to employees of the Company, and for the grant of non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of stock awards to employees, directors, and consultants, including employees and consultants of affiliates of the Company

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(collectively, “stock based awards”). The 2022 Plan is a successor to the 2019 Stock Option Plan. (“2019 Plan”). Initially, the maximum number of shares of common stock that may be issued under the 2022 Plan after it became effective was 6,787,652 shares, which is the sum of (i) 3,905,911 new shares; plus (ii) the number of shares that was available for issuance under the 2019 Plan at the time the 2022 Plan became effective; and (iii) any shares subject to outstanding stock options or other stock awards that were granted under the 2019 Plan that are forfeited, terminated, expired or are otherwise not issued. In addition, the number of shares of common stock reserved for issuance under the 2022 Plan will automatically increase on January 1st of each calendar year, starting on January 1, 2023 and continuing through January 1, 2032, in an amount equal to 5% of the total number of shares of common stock outstanding on the last day of the calendar month before the date of each automatic increase, or a lesser number of shares determined by the Board of Directors. The maximum number of shares of common stock that may be issued on the exercise of incentive stock options under the 2022 Plan is 20,362,956.

As of June 30, 2022 and December 31, 2021, a total of 3,947,670 and 3,368,572 awards, respectively, were available for issuance under the 2022 Plan and 2019 Plan, respectively..

The following is a summary of the Company’s outstanding stock option activity:

	Stock Option Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in Years)		Aggregate Intrinsic Value
Outstanding, January 1, 2022		2,617,072		$	6.19		9.56		—
Granted		68,525			16.51	9.79			—
Exercised		—			—		—		—
Expired/cancelled		—			—		—		—
Outstanding, March 31, 2022		2,685,597		$	6.96		9.37		—
Granted		101,637		$	16.26		6.43		—
Exercised		—			—		—		—
Expired/cancelled		(4,400	)		16.00		—		—
Outstanding, June 30, 2022		2,782,834		$	7.27		9.15	$	32,258,909
Expected to vest, June 30, 2022		2,782,834		$	7.27		9.15	$	32,258,909
Options exercisable, June 30, 2022		628,945		$	6.83		8.88	$	7,553,987

Unrecognized compensation cost related to stock option awards of $13.7 million as of June 30, 2022, is expected to be recognized as expense over a weighted average period of 3.07 years. The total fair value of options vested was $1.6 million and $1.5 million, for the six months period ended June 30, 2022 and 2021, respectively.

Outstanding stock options, if not exercised, expire ten years from the date of grant. The Company issues new shares of common stock upon exercise of stock options. The weighted average grant date fair value per share for the outstanding options at June 30, 2022 and December 31, 2021 was $10.24 and $5.42, respectively.

The Company determined the grant-date fair value of stock options using the Black-Scholes option pricing model. The fair value of each stock option grant was determined using assumptions that are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with a term equivalent to the option. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on companies in the therapeutics and pharmaceutical industries. The expected term of stock options represents the weighted average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determined the expected life assumption using the simplified method, which is an average of the options ordinary vesting period and the contractual term. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts at the time of grant. The Company recognizes forfeitures on an actual basis and, as such, did not estimate forfeitures to calculate stock-based compensation.

The following table presents the weighted average assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted during the following periods:

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	Three Months Ended June 30,	Six Months Ended June 30,
	2022	2022
Exercise price	$16.26	$16.36
Stock price on date of grant	$16.26	$16.36
Expected term (years)	6.5	6.5
Expected stock price volatility	75.59%	76.37%
Risk-free rate of interest	2.78%	2.52%
Expected dividend yield	0%	0%

There is a high degree of subjectivity involved when using option-pricing models to estimate stock-based compensation. There are currently no market-based mechanisms or other practical applications to verify the reliability and accuracy of the estimates stemming from these models, nor is there a means to compare and adjust the estimates to actual values. Although the fair value of the employee stock-based awards is determined using an option-pricing model, the value may not be indicative of the fair value that would be observed in a market transaction between a willing buyer and a willing seller. If factors change and the Company employs different assumptions when valuing its options, the compensation expense that the Company records in the future may differ significantly from what it has historically reported.

Restricted Stock Units

In 2022, certain employees were awarded restricted stock units with time-based vesting. During the three and six months ended June 30, 2022, the Company granted to certain employees 30,148 time-based vesting restricted stock units, with a weighted average grant date fair value of $16.00. As of June 30, 2022, none of the restricted stock units had vested. As of June 30, 2022, the Company had unrecognized stock-based compensation expense related to restricted stock units of approximately $0.4 million with a weighted average vesting period of approximately 1.50 years. The expense is recognized over the vesting period of the award.

The Company recognized the following compensation cost related to employee stock-based compensation activity:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Research and development	$	257,705	$	40,121	$	485,295	$	531,930
General and administrative		983,452		253,728		1,980,070		1,151,874
Total	$	1,241,157	$	293,849	$	2,465,365	$	1,683,804

7. Net Loss per Share Attributable to Common Stockholders

Net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same.

The following weighted average common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect for the following periods:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Redeemed convertible preferred stock (if converted)		—		10,504,199		—		10,504,199
2019 Warrants		—		739,463		—		739,463
Outstanding equity awards exercisable		1,052,120		34,960		1,077,534		34,198

8. Related-Party Transactions

CinRx Pharma LLC and Subsidiaries (“CinRx”)

Certain former executives and employees of the Company, including the Company’s former chief executive officer and a former member of the Company’s board of directors, are members of CinRx’s board of managers and/or have equity investments in CinRx. The Company received business management services from CinRx from time to time as needed, under a management services agreement, which was terminated on February 2, 2022. There were no business management service fees from CinRx during the three and six months ended June 30, 2022. During the three and six months ended June 30, 2021, the Company recorded business management fees totaling $0.5 million and $0.8 million, respectively. For the three months ended June 30, 2021, $0.3 million are included in research and development expenses, while $0.2 million are in general and administrative expenses on the condensed statement of operations. For the six months ending June 30, 2021, $0.5 million of the fees are included in research and development expenses, while $0.3 million are in general and administrative expenses on the condensed statement of operations.

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9. Commitments and Contingencies

Lease

On February 24, 2022, the Company entered into a license agreement, commencing April 1, 2022, for 5,400 square feet of office space in Waltham, Massachusetts, which is the Company's new headquarters. The annual rent is $0.3 million. As this license agreement has a term of less than 12 months, the Company has not recorded it on the condensed balance sheet, as allowed under ASC Topic 842, Leases ("ASC 842"). The Company also has an agreement to lease 221 square feet of office space at 7875 Montgomery Rd. Suite 42, Cincinnati, OH 45236 from COHatch Cincinnati for $2,850 per month. As this lease has a term of less than 12 months, the Company has not recorded it on the condensed balance sheet, as allowed under ASC 842. The Company's total rent expense for the three and six months ended June 30, 2022, were $0.1 million and $0.2 million, respectively, recorded in general and administrative expense on our condensed statements of operations. No rent expense was recognized for the three and six months ended June 30, 2021.

10. Employee Benefit Plan

The Company maintains a defined contribution 401(k) plan available to full time employees. Employee contributions are voluntary and are determined on an individual basis, limited by the maximum amounts allowable under federal tax regulations. The Company provides a safe harbor contribution of 4% of the employee's salary. The Company’s safe harbor contributions recorded for the three and six months ending June 30, 2022, totaled approximately $0.1 million and $0.1 million, respectively, are included in research and development expense and general and administrative expense on the condensed statements of operations. The 401(k) plan was not in place during the three and six months ended June 30, 2021.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion of the financial condition and results of operations of CinCor Pharma, Inc. should be read in conjunction with the unaudited condensed financial statements and the notes to those statements included in this Quarterly Report on Form 10-Q, our audited financial statements and related notes thereto for the year ended December 31, 2021 included in our most recent Annual Report on Form 10-K filed with the SEC on March 22, 2022. Some of the information contained in this discussion and analysis including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risk, uncertainties and assumptions. You should read the “Risk Factors” sections of this Quarterly Report Form 10-Q, our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, and our other filings with the SEC, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Please also refer to the section under the heading “Note Regarding Forward-Looking Statements.”

Overview

We are a clinical-stage biopharmaceutical company focused on developing our lead clinical candidate, baxdrostat (CIN-107) , for the treatment of hypertension and other cardio-renal diseases. Baxdrostat is a highly selective, oral small molecule inhibitor of aldosterone synthase, the enzyme responsible for the synthesis of aldosterone in the adrenal gland. Baxdrostat has been designed to use differentiated mechanism of action, direct inhibition of aldosterone synthase production, with the goal of providing an improved treatment for patients suffering from hypertension, or high blood pressure. We are conducting multiple Phase 2 clinical trials using baxdrostat in differing populations of patients, all of whom are hypertensive. The most advanced of our trials, called BrigHtn, was conducted in patients whose blood pressure is not controlled despite treatment with three or more antihypertensive agents, one of which must be a diuretic; these patients are designated as having treatment resistant hypertension, or rHTN. In June 2022 the last patient visit in the BrigHtn trial was conducted with 248 patients completing the trial. On August 8, 2022, we announced topline results of our BrigHtn trial. A separate Phase 2 clinical trial, referred to as HALO, is evaluating baxdrostat’s effects on patients whose blood pressure is not controlled despite treatment with up to two antihypertensive agents, referred to as uncontrolled hypertension, or uHTN. Enrollment for our HALO trial was completed in July 2022 with 249 patients randomized. Additionally, an open-label extension clinical trial, referred to as the OLE trial, for patients previously enrolled in our HALO trial has been initiated to evaluate the long-term safety and tolerability of baxdrostat over an extended treatment period of up to 52 weeks. A third patient population being investigated has a condition called primary aldosteronism, or PA, where overproduction of aldosterone by non-malignant tumors or abnormal collections of aldosterone-producing cells in the adrenal glands leads to an aggressive form of hypertension. The trial in the PA patients, referred to as spark-PA, was also initiated in 2021 and was revised under a recent amendment designed to accelerate recruitment in this less commonly diagnosed form of hypertension. Additionally, in June 2022 we enrolled our first patient into our Phase 2 clinical trial, which we refer to as our figHTN-CKD trial, to evaluate the utility of baxdrostat in lowering the blood pressure of patients with chronic kidney disease, or CKD, as well as exploring the potential impact of the drug on slowing the progression of renal disease using biomarkers of that progression.

Since our inception in 2018, we have focused primarily on organizing and staffing our company, business planning, and acquiring and progressing our lead product candidate, baxdrostat, through clinical development after in-licensing the compound from F. Hoffmann-La Roche Ltd and Hoffmann La-Roche Inc., whom we collectively refer to as Roche, in 2019, and raising capital. We were initially founded as a subsidiary of CinRx Pharma, LLC, or CinRx, and spun out as an independent company in 2019.

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On January 11, 2022, we completed an initial public offering, or the IPO, of our common stock pursuant to which we issued and sold 13,290,813 shares of our common stock at a price to the public of $16.00 per share. The aggregate net proceeds from the IPO, were approximately $193.6 million after deducting underwriting discounts and commissions of $14.9 million and offering expenses of approximately $4.5 million. Upon completion of the IPO, all outstanding shares of Series A and Series B redeemable convertible preferred stock converted to common stock at a 3.4-for-1 in line with the reverse stock split of the Company’s common stock. In addition, the IPO also resulted in the automatic net exercise of the three outstanding warrants to purchase common stock issued to Roche, or the Roche Warrants, for an aggregate of 852,788 shares of common stock.

We do not have any product candidates approved for sale and have not generated any revenue from product sales or licensing agreements. From inception through June 30, 2022, we have funded our operations primarily through equity financings, and have raised an aggregate of approximately $405.5 million of gross proceeds from the sale of shares of our preferred stock and the IPO. As of June 30, 2022, we had cash, cash equivalents and marketable securities on hand of $294.3 million.

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for baxdrostat or any future product candidates, if ever. In addition, if we obtain regulatory approval for baxdrostat or any future product candidates and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Our failure to raise capital or enter into such agreements as, and when, needed, could have a negative effect on our business, results of operations and financial condition. If we are unable to obtain funding, we will be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. Although we continue to pursue these plans, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all.

Recent Developments

Topline Results of BrigHtn Trial

Overview

Our BrigHtn trial was a Phase 2, randomized, double-blind, multicenter, placebo-controlled, dose-ranging clinical trial to evaluate the efficacy and safety of baxdrostat in patients with rHTN. Patients with rHTN were defined as being on a stable regimen of at least three antihypertensive agents at their maximally tolerated doses, one of which must be a diuretic, with a mean seated blood pressure, or BP, equal to or greater than 130/80 mm Hg. The primary endpoint was the change from baseline in mean seated systolic blood pressure, or SBP, after 12 weeks of treatment. The secondary objectives were to evaluate the change from baseline in mean seated diastolic blood pressure, or DBP, with each of the selected dose strengths of baxdrostat compared to placebo and to evaluate the percentage of patients achieving a seated BP response of less than 130/80 mm Hg with each of the dose strengths of baxdrostat compared to placebo after 12 weeks of treatment. A data monitoring committee, or DMC, determined that the trial met pre-specified statistical criteria of overwhelming efficacy at the highest dose, allowing completion of the trial with 275 patients randomized.

Summary of Results

BrigHtn was initiated in July 2020 in the United States. In the trial, 275 subjects were randomly assigned to one of the four treatment cohorts (0.5mg, 1 mg, 2 mg of baxdrostat or placebo once daily) and 248 patients completed the trial. Fifteen of the 27 discontinued patients withdrew due to consent withdrawal (n = 7) or were lost to follow-up (n = 8), with most occurring in late 2020 and early 2021 when we believe the Coronavirus Disease 2019 (COVID-19) pandemic situation may have interfered with patient retention.

Treatment-emergent serious adverse events, or TESAEs, were reported in 10 patients and deemed by investigators to be unrelated to baxdrostat. These TESAEs included hyponatremia, hyperkalemia, cellulitis, urinary tract infection, dehydration, hyperglycemia, arthralgia, dizziness, syncope, acute kidney injury, nephrolithiasis, acute respiratory failure, and respiratory failure, with one patient discontinuing trial participation due to adverse events of intervertebral disc degeneration (n = 1) and one patient experiencing a total of 6 serious adverse events, or SAEs, with 3 of these 6 SAEs — hyperglycemia, hyponatremia and hyperkalemia — leading to trial withdrawal. Both patient discontinuations were deemed by the investigator to be unrelated to study drug.

The demographics and baseline characteristics of patients in the four study arms were well balanced. Most of the participants were over

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60, overweight, or obese and had normal or mildly impaired renal functions. All but one patient was taking at least three antihypertensive medications including a diuretic. In addition, over 90% of patients took an antihypertensive agent in the renin angiotensin-aldosterone
system, or RAAS, class.

 

Efficacy Results

Data from the BrigHtn trial demonstrated that treatment with baxdrostat at 1 mg and 2 mg led to a statistically significant lowering of SBP in patients with rHTN. Patients treated with baxdrostat at the 2 mg dose demonstrated a 20.3 mmHg reduction in SBP compared to patients in the placebo cohort which demonstrated a 9.4 mm Hg reduction in SBP, yielding a model adjusted, statistically significant, placebo-corrected decline of 11.0 mmHg (95% Confidence Interval [CI] -16.4 mmHg, -5.5 mmHg) (p value = 0.0001). The 1 mg dose cohort demonstrated a 17.5 mmHg reduction in SBP, resulting in a statistically significant placebo adjusted SBP decline of 8.1 mmHg (p value = 0.003). The observed treatment effect of baxdrostat on the 0.5 mg dose cohort was modestly greater (12.1 mmHg reduction) than that of the placebo and this difference did not reach statistical significance. The DBP decreased by 14.3 mmHg, 11.8 mmHg and 8.6 mmHg in the 2 mg, 1 mg and 0.5 mg dose cohorts, respectively, compared to the 9.2 mmHg decrease in the placebo cohort. Table 1 below presents the effects of baxdrostat on blood pressure in the BrigHtn trial.

Table 1. Baxdrostat Treatment Effects on Blood Pressure

Characteristic     Category/Statistics	Placebo (N = 69)	0.5 mg Baxdrostat (N = 69)	1 mg Baxdrostat (N = 69)	2 mg Baxdrostat (N = 67)
Systolic Blood Pressure (mmHg)
Baseline Mean	148.9	147.6	148.3	147.3
Standard Deviation	12.38	12.49	12.17	11.82
LS mean change (SE)	-9.4 (1.88)	-12.1 (1.91)	-17.5 (1.95)	-20.3 (2.05)
LS mean difference (SE)		-2.7 (2.68)	-8.1 (2.72)	-11.0 (2.78)
95% CI		(-8.0, 2.6)	(-13.5, -2.8)	(-16.4, -5.5)
p value		0.3110	0.0030	0.0001
Diastolic Blood Pressure (mmHg)
Baseline Mean	88.2	87.6	87.7	88.2
Standard Deviation	6.13	7.71	5.97	7.13
LS mean change (SE)	-9.2 (1.22)	-8.6 (1.23)	-11.8 (1.26)	-14.3 (1.31)
LS mean difference (SE)		0.5 (1.74)	-2.7 (1.75)	-5.2 (1.79)
95% CI		(-2.9, 4.0)	(-6.1, 0.8)	(-8.7, -1.6)
p value		0.7536	0.1298	0.0042

One specific subgroup analysis was performed in patients with baseline SBP less than 145 mmHg and greater than or equal to 145 mmHg. Patients in the BrigHtn trial dosed with baxdrostat experienced a greater reduction in SBP if they had baseline SBP value of greater than or equal to 145 mmHg as reflected in Table 2 below.

Table 2: Subgroup Analysis of Patients with Baseline SBP < 145 mm Hg and ≥ 145 mm Hg

Subgroups by Baseline SBP

SBP	Statistic	Placebo	0.5 mg Baxdrostat	1 mg Baxdrostat	2 mg Baxdrostat
SBP<145	N	28	28	26	26
	LSM (SE)	-11.5 (3.06)	-9.4 (3.06)	-14.9 (3.16)	-20.4 (3.14)
	LSM difference (SE)		2.1 (4.13)	-3.4 (4.19)	-8.9 (4.19)
	95% CI		(-6.0, 10.2)	(-11.7, 4.8)	(-17.1, -0.6)
	P value		0.6138	0.4133	0.0346
SBP ≥ 145	N	39	37	34	28
	LSM (SE)	-8.0 (2.59)	-14.1 (2.62)	-19.5 (2.69)	-20.1 (2.88)
	LSM difference (SE)		-6.1 (3.54)	-11.5 (3.58)	-12.1 (3.75)
	95% CI		(-13.1, 0.9)	(-18.5, -4.4)	(-19.5, -4.7)
	P value		0.0864	0.0015	0.0014

Abbreviations: CI, confidence interval; LSM, least squares mean; mg, milligram; SBP, systolic blood pressure; SE, standard error.

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Pharmacodynamic Assessment

Blood and urine samples were collected for determination of the pharmacodynamic parameters related to baxdrostat’s mechanism of action, aldosterone suppression. The pharmacodynamic results demonstrated a baxdrostat treatment related decrease in serum aldosterone concentration, increase of the plasma renin activity, or PRA, without significantly affecting the total cortisol concentration. These data demonstrated that treatment with baxdrostat resulted in an average 50% to 60% reduction of serum aldosterone, increased PRA several-fold yet with no reduction in total serum cortisol. These hormonal data provide significant evidence to support the mechanism by which baxdrostat’s inhibition of aldosterone synthesis produces a significant impact on blood pressure levels without lowering serum cortisol levels. The PK profile of baxdrostat was substantially consistent with earlier data published, further supporting its dose-dependent increases in plasma baxdrostat with a half-life that supports once daily dosing.

Safety

Treatment Emergent AEs and SAEs

Administration of baxdrostat once daily for 12 weeks was well tolerated. 120 of the 274 patients (43.8%) experienced a total of 232 TEAEs, as reflected in Table 3 below. A higher percentage of patients in the 1 mg (52.2%) and 2 mg (47.8%) dose cohorts experienced TEAEs compared to that in the 0.5 mg (34.8%) or placebo (40.6%) cohort. The most frequently occurring TEAEs experienced by 5% or more patients in any treatment cohort were urinary tract infection, hyperkalemia, dizziness, headache and fatigue. Most of the TEAEs were mild (62.5%) in severity and deemed not related (89.2%) to baxdrostat by the investigators. Table 3 presents an overview of the adverse events in the study population.

Table 3. Overview of Adverse Events

	Placebo (N=69)	0.5 mg Baxdrostat (N=69)	1 mg Baxdrostat (N=67)	2 mg Baxdrostat (N=67)	Total (N=275)
	n (%) e	n (%) e	n (%) e	n (%) e	n (%) e
Any treatment-emergent AEs (TEAEs)	28 (40.6) 50	24 (34.8) 38	36 (52.2) 77	32 (47.8) 67	120 (43.8) 232
Any study drug-related TEAEs	1 (1.4) 1	7 (10.1) 7	9 (13.0) 14	3 (4.5) 3	20 (7.3) 25
Any TEAEs of special interest	0 (0.0) 0	1 (1.4) 1	5 (7.2) 6	2 (3.0) 3	8 (2.9) 10
Any serious AEs (SAEs)	2 (2.9) 3	0 (0.0) 0	2 (2.9) 3	6 (9.0) 12	10 (3.6) 18
Any TEAEs leading to dosing discontinuation	0 (0.0) 0	2 (2.9) 2	4 (5.8) 5	2 (3.0) 5	8 (2.9) 12
Any TEAEs leading to study discontinuation	0 (0.0) 0	0 (0.0) 0	1 (1.4) 1	1 (1.5) 3	1 (1.5) 3
Any AEs leading to death	0 (0.0) 0	0 (0.0) 0	0 (0.0) 0	0 (0.0) 0	0 (0.0) 0

Abbreviations: AE, adverse event; SAE, serious adverse event; TEAE, treatment-emergent adverse event; TESAE, treatment- emergent serious adverse event.

These events may be related to the decline in blood pressure (e.g., dizziness, syncope, palpitation) or baxdrostat’s mechanism of action (i.e., hyperkalemia, hyponatremia, renal impairment). Although there were more patients who experienced urinary tract infection and COVID-19 in the baxdrostat 1 mg or 2 mg cohorts, no causal relationship was identified.

Eighteen TESAEs were experienced by 10 patients. There were no deaths in the trial, and all SAEs were assessed by the investigators to be unrelated to baxdrostat. A 72-year-old white male subject with suspected urosepsis in the 2 mg dose cohort experienced six SAEs of acute kidney injury, urinary tract infection, dehydration, hyperglycemia, hyperkalemia and hyponatremia on day 15 in the trial. The investigator assessed the events to be unrelated to baxdrostat, and the patient withdrew from participation in the trial due to these metabolic derangements. There were three patients who experienced two SAEs each: a patient in the 1 mg dose cohort with pyelonephritis (inflammation of the kidney due to bacterial infection) and nephrolithiasis (kidney stones), a patient in the 2 mg dose cohort with respiratory failure and cellulitis, and a third patient receiving placebo with pyelonephritis and pneumonia. The remaining SAEs were each experienced by a single patient.

 

Serum Electrolytes

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Aldosterone plays a direct role in the pathogenesis of hypertension by increasing renal absorption of sodium and water while promoting excretion of potassium, which can result in the electrolyte abnormalities of hyperkalemia or hyponatremia. Moreover, the decrease in SBP expected with aldosterone inhibitors can lead to an apparent decline in determination of eGFR. The overall change in serum potassium from baseline to end of treatment was a mean (standard deviation) of -0.08 (0.429) mEq/L in the placebo cohort, and it rose in the baxdrostat cohorts by 0.19 (0.474) mEq/L in the 0.5 mg dose group, 0.36 (0.481) mEq/L in the 1 mg dose cohort and 0.29 mEq/L (0.380) in the 2 mg dose cohort.

There were three patients with moderate hyperkalemia (potassium > 6.0 mEq/L) in the 1 mg and 2 mg dose cohorts for an overall rate of 2.2%. Hyperkalemia typically represented isolated values which resolved after dietary advice and without modification of baxdrostat dosing.

There were two patients in the placebo cohort with moderate hypokalemia; there were no cases in any baxdrostat dose cohorts.
Similarly, baxdrostat treatment was associated with a slight decrease in serum sodium concentration. The range of decline in sodium was from baseline to end of treatment was a mean (SD) of -1.2 (2.73) mEq/L in the 0.5 mg dose cohort, -1.1 (3.03) mEq/L in the 1 mg cohort group to -2.4 mEq/L (2.94) in the 2 mg dose cohort which posed no significant clinical concerns.

No instances of hyperkalemia or hyponatremia led to drug/trial discontinuation.
 

Roche License Agreement

In May 2019, we entered into a license agreement, or the Roche Agreement, with Roche, pursuant to which we obtained an exclusive, worldwide, royalty-bearing license under certain patents and specified know-how owned or controlled by Roche and Roche’s interest in joint patents and covering certain specified small molecule aldosterone synthase inhibitors, or the Roche Technology, to research, develop, register, use, make, import, export, market, distribute, sell (as well as the right to have each of the foregoing done, as defined in the Roche Agreement) and otherwise exploit products containing such aldosterone synthase inhibitors, or the Licensed Products, for any and all uses, including the treatment, prevention or diagnosis of any and all diseases and medical conditions in humans and animals.

Components of Results of Operations

Revenue

To date, we have not recognized any revenue from any sources, including from product sales or licensing agreements, and we do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for baxdrostat or any future product candidate is successful and results in regulatory approval, we may generate revenue in the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including our research and discovery efforts and the development of baxdrostat or any future product candidates. We expense research and development costs as incurred, which include:

•external research and development expenses incurred under arrangements with third parties, such as Contract Research Organizations, or CROs, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;

•costs related to acquiring, developing, and manufacturing clinical study material for our preclinical studies and clinical trials, including fees paid to contract manufacturing organizations, or CMOs;

•personnel costs for employees and third party contractors/consultants involved in managing and supporting R&D activities

•laboratory supplies and research materials;

•upfront, milestone and maintenance fees incurred under license, acquisition and other third-party agreements; and

•costs related to compliance with clinical regulatory requirements.

Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided to us by our vendors and clinical sites and analyzing the progress of clinical trials or other services performed. Significant judgment and estimates are made in determining the accrued expense balances at the end of any reporting period.

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We track external research and development costs on a program-by-program basis. External costs include fees paid to consultants, contractors and vendors, including CMOs and CROs, in connection with our clinical activities. We currently only have one product development program, baxdrostat.

Research and development activities will continue to be central to our business model. We anticipate that our research and development expenses will increase for the foreseeable future as we advance our product candidates through clinical trials, as well as acquire new product candidates. We also expect higher employee-related expenses, including higher stock-based compensation expenses, as well as higher consulting costs as we hire additional resources to support increasing development activity.

The successful development of baxdrostat or any future product candidate is highly uncertain. We cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete development of baxdrostat or any future product candidate due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of baxdrostat or any future product candidate, if they are approved.

The duration, costs and timing of the clinical development of our product candidates will depend on a variety of factors that include, but are not limited to, the following:

•the scope, rate of progress, and expenses of our ongoing research activities as well as any preclinical studies and clinical trials and other research and development activities;

•the number and scope of clinical programs we decide to pursue;

•the uncertainties in clinical trial design and patient enrollment rates, and any changes we make to our clinical trial protocols;

•establishing an appropriate safety and efficacy profile;

•successful enrollment in and completion of clinical trials;

•whether baxdrostat shows safety and efficacy in our clinical trials;

•the timing, receipt and terms of marketing approvals from applicable regulatory authorities;

•making arrangements with third-party CMOs for manufacturing;

•obtaining and maintaining patent and trade secret protection and regulatory exclusivity for baxdrostat and any future product candidate;

•commercializing product candidates, if and when approved, whether alone or in collaboration with others; and

•continued acceptable safety profile of the products following any regulatory approval.

A change in the outcome of any of these variables with respect to the development of baxdrostat or any future product candidate would significantly change the costs and timing associated with the development of those product candidates. We may never succeed in achieving regulatory approval for any product candidate. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on other product candidates. For example, if the U.S. Food and Drug Administration, the European Medicines Agency, or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.

General and Administrative Expenses

General and administrative expenses consist primarily of compensation and employee-related costs for our finance, human resources and other administrative personnel, including salaries, benefits and other related costs, as well as expenses for outside professional services, including legal, accounting and audit services and other consulting fees, rent expense, other general administrative expenses, and stock-based compensation.

We expect our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates, potential commercialization efforts, and increased costs associated with operating as a public company. These increases will likely include additional costs related to the hiring of new personnel, including higher stock-based compensation expenses, and fees to outside consultants, as well as other related expenses. We also anticipate that we will incur significantly increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company.

Interest Income

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Interest income consists primarily of interest income received on our cash, cash equivalents and marketable securities.

Change in Fair Value of Warrant Derivative Liabilities

The change in fair value of warrant derivative liabilities consists of the change in fair value related to the three freestanding detachable stock purchase warrants issued to Roche in connection with the Roche Agreement, which we collectively refer to as the Roche Warrants. The Roche Warrants automatically net exercised in whole immediately prior to the IPO, which resulted in the issuance of 852,788 shares of our common stock.

The grant date fair value of the Roche Warrants were calculated using the Black Scholes valuation model. The valuation models used require the input of subjective assumptions, including assumptions about the expected life of the Roche Warrant, share price volatility and as a privately held company prior to the IPO, the estimated fair value of our common stock. These assumptions used represent our best estimates at the time of issuance and in subsequent reporting periods, but the estimates involve inherent uncertainties and the application of our judgment.

Results of Operations

Results of Operations for the Three Months Ended June 30, 2022 and 2021

The following table summarizes our results of operations for the three months ended June 30, 2022 and 2021:

	Three Months Ended June 30,
	2022			2021
Operating expenses:
Research and development	$	17,161,014		$	3,998,391
General and administrative		4,191,767			1,176,018
Total operating expenses		21,352,781			5,174,409
Loss from operations		(21,352,781	)		(5,174,409	)
Other (income) expense:
Interest income		(277,377	)		(1,539	)
Change in fair value of warrant derivative liabilities		—			1,209,829
Total other (income) expense, net		(277,377	)		1,208,290
Net loss	$	(21,075,404	)	$	(6,382,699	)

Research and Development Expenses

Research and development expenses for the three months ended June 30, 2022 were $17.2 million, compared to $4.0 million for the three months ended June 30, 2021. The increase of $13.2 million, or 329%, was primarily due to the progression of several Phase 2 clinical trials including the full enrollment in our HALO trial, the initiation of our figHTN-CKD trial, increased chemistry, manufacturing and controls spending and the addition of several important full-time research and development resources.

We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, including investments in manufacturing, as our programs advance into later stages of development, and we continue to conduct clinical trials. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. We will also incur increased expenses related to headcount to support our continued research activities and development of our product candidates.

General and Administrative Expenses

General and administrative expenses were $4.2 million for the three months ended June 30, 2022, compared to $1.2 million for the three months ended June 30, 2021. The increase of $3.0 million, or 256%, is primarily related to the increased personnel costs, as we hired our first employee in March 2021 and continued to build out our in house team primarily based in Waltham (reaching 21 employees by June 30, 2022), as well as increased legal and professional fees and other costs associated with operating as a public company.

We anticipate that our general and administrative expenses will increase as we continue to build our infrastructure.

Interest Income

Interest income was $0.3 million for the three months ended June 30, 2022, compared to $1.5 thousand for the

three months ended June 30, 2021, reflecting interest earned on cash and cash equivalents and marketable securities. The difference was attributed primarily to our increased cash and cash equivalents, resulting from the IPO and our investment in marketable securities during the three months ended June 30, 2022.

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Change in Fair Value of Warrant Derivative Liabilities

The change in the fair value of the warrant derivative liabilities was $0 for the three months ended June 30, 2022, compared to $1.2 million for the three months ended June 30, 2021. The $1.2 million decrease is due to the conversion of warrants to common stock. The Roche Warrants were issued in connection with the Roche Agreement and in connection with our Series A redeemable convertible preferred stock financing in 2019, with an additional warrant issued in connection with our Series B redeemable convertible preferred stock financing. Prior to the IPO, we classified the Roche Warrants as a liability on our condensed balance sheets which we remeasured to fair value at each reporting date. We recognize changes in the fair value of the warrant derivative liabilities as a component of other (income) expense, net in our condensed statements of operations. The Roche Warrants were automatically net exercised for an aggregate of 852,788 shares of common stock upon the completion of the IPO in January 2022.

Results of Operations for the Six Months Ended June 30, 2022 and 2021

The following table summarizes our results of operations for the six months ended June 30, 2022 and 2021:

	Six Months Ended June 30,
	2022			2021
Operating expenses:
Research and development	$	26,851,612		$	7,487,821
General and administrative		8,205,513			2,099,583
Total operating expenses		35,057,125			9,587,404
Loss from operations		(35,057,125	)		(9,587,404	)
Other (income) expense:
Interest income		(328,825	)		(5,952	)
Change in fair value of warrant derivative liabilities		3,044,006			2,419,657
Total other expense, net		2,715,181			2,413,705
Net loss	$	(37,772,306	)	$	(12,001,109	)

Research and Development Expenses

Research and development expenses for the six months ended June 30, 2022 were $26.9 million, compared to $7.5 million for the six months ended June 30, 2021. The increase of $19.4 million, or 259%, was primarily due to the progression of several Phase 2 clinical trials including the full enrollment of HALO, the initiation of our CKD trial, increased chemistry, manufacturing and controls spending and the addition of several important full-time research and development resources.

We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, including investments in manufacturing, as our programs advance into later stages of development, and we continue to conduct clinical trials. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. We will also incur increased expenses related to headcount to support our continued research activities and development of our product candidates.

General and Administrative Expenses

General and administrative expenses were $8.2 million for the six months ended June 30, 2022, compared to $2.1 million for the six months ended June 30, 2021. The increase of $6.1 million, or 291%, is primarily related to the increased personnel costs, as we hired our first employee in March 2021 and continued to build out our in house team primarily in Waltham (reaching 21 employees by June 30, 2022), as well as increased legal and professional fees and other costs associated with operating as a public company.

We anticipate that our general and administrative expenses will increase as we continue to build our infrastructure.

Interest Income

Interest income was $328.8 thousand for the six months ended June 30, 2022, compared to $6.0 thousand for the

six months ended June 30, 2021, reflecting interest earned on cash and cash equivalents and marketable securities. The difference was attributed primarily to our increased cash and cash equivalents, resulting from the IPO and our investment in marketable securities during the six months ended June 30, 2022.

Change in Fair Value of Warrant Derivative Liabilities

The change in the fair value of the warrant derivative liabilities was $3.0 million for the six months ended June 30, 2022, compared to $2.4 million for the six months ended June 30, 2021. The $0.6 million increase is due to the increase in the common stock price. The Roche Warrants were issued in connection with the Roche Agreement and in connection with our Series A redeemable convertible preferred stock financing in 2019, with an additional warrant issued in connection with our Series B redeemable convertible preferred stock financing. Prior to the IPO, we classified the Roche Warrants as a liability on our condensed balance sheets which we remeasured to fair value at each reporting date. We recognize changes in the fair value of the warrant derivative liabilities as a component of other

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(income) expense, net in our condensed statements of operations. The Roche Warrants were automatically net exercised for an aggregate of 852,788 shares of common stock upon the completion of the IPO in January 2022.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. From inception through June 30, 2022, we have funded our operations through private equity financings and the IPO, and have raised an aggregate of approximately $405.5 million of gross proceeds from the sale of shares of our preferred and common stock. The net proceeds from these sales totaled $382.7 million. As of June 30, 2022, we had cash, cash equivalents and marketable securities on hand of $294.3 million. Until such time, if ever, as we can generate substantial revenue, we expect to finance our cash needs through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements.

Cash Flows

Comparison of Six Months Ended June 30, 2022 and 2021

The following table summarizes our cash flows for the six months ended June 30, 2022 and 2021:

	Six Months Ended June 30,
	2022			2021
Net cash used in operating activities	$	(37,266,294	)	$	(13,582,263	)
Net cash used in investing activities		(167,267,814	)		—
Net cash provided by financing activities		195,548,103			1,232,799
Net decrease in cash and cash equivalents	$	(8,986,005	)	$	(12,349,464	)

Operating Activities

We have historically experienced negative operating cash outflows as we continue clinical development of baxdrostat. Our net cash used in operating activities primarily results from our net loss adjusted for non-cash expenses and changes in working capital components. Our primary uses of cash from operating activities are amounts due to CROs for the conduct of our clinical programs and employee-related expenditures for research and development, and general and administrative activities. Our cash flows from operating activities will continue to be affected by spending to advance and support our clinical development and other operating and general administrative activities.

For the six months ended June 30, 2022, net cash used in operating activities was $37.3 million and was primarily related to cash payments for clinical development activities, personnel costs, legal and professional fees and other costs associated with operating activities.

For the six months ended June 30, 2021, net cash used in operating activities was $13.6 million and was primarily related to cash payments for clinical development activities and personnel-related costs under our Management Services Agreement with CinRx, legal and professional fees, and other costs associated with operating activities.

Investing Activities

Cash used in investing activities for the six months ended June 30, 2022 of $167.3 million was attributable to $227.2 million for the purchase of marketable securities, partially offset by the maturity of $60.0 million of marketable securities. There were no investments in marketable securities for the six months ended June 30, 2021.

Financing Activities

Net cash provided by financing activities for the six months ended June 30, 2022 was $195.5 million, consisting of net cash proceeds from the IPO realized in the first quarter of 2022. Total net proceeds from the IPO were $193.6, of which $2.0 million of issuance costs were during the fourth quarter of 2021.

Net cash provided by financing activities for the six months ended June 30, 2021 of $1.2 million was attributable to proceeds received from the exercise of stock options by certain employees.

Funding Requirements

As of June 30, 2022, our cash and cash equivalents and marketable securities on hand were $294.3 million. Based on our current plans, we believe that our existing cash and cash equivalents and available for sale securities, should enable us to fund our operating expenses and capital expenditure requirements through 2024, including completing all of our ongoing Phase 2 trials, our currently planned Phase 3 clinical program in hypertension, CMC development
and GMP batch production, and the additional activities needed

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to
complete our planned new drug application submission. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect. This estimate is based on our current business plan and does not include any additional expenditures related to potential future development of additional product candidates or indications or resulting from the potential in-licensing or acquisition of additional product candidates or technologies, or any associated development we may pursue. This period could be shortened if there are any significant increases beyond our expectations in spending on development programs or more rapid progress of development programs than anticipated.

We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates through preclinical and clinical development, seek regulatory approval and pursue commercialization of any approved product candidates. We expect that our research and development and general and administrative costs will increase in connection with our planned clinical development and pre-commercialization activities. In addition, we expect to incur increased costs associated with operating as a public company.

If we receive regulatory approval for baxdrostat, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.

Our future capital requirements will depend on a number of factors, including:

•the costs of conducting preclinical studies and clinical trials;

•the scope, progress, results and costs of discovery, preclinical development, laboratory testing, and clinical trials for product candidates we may develop, if any;

•the costs, timing, and outcome of regulatory review of our product candidates;

•our ability to establish and maintain collaborations on favorable terms, if at all;

•the achievement of milestones or occurrence of other developments that trigger payments under any license or collaboration agreements we might have at such time;

•the costs and timing of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;

•the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;

•the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining and enforcing our intellectual property rights, and defending intellectual property-related claims;

•our headcount growth and associated costs as we expand our business operations and research and development activities;

•the costs of building out internal accounting, legal, compliance and other operational and administrative functions;

•the timing and size of any milestone payments required under our existing or future arrangements, including the Roche Agreement; and

•the costs of operating as a public company.

Our existing cash, cash equivalents and available for sale securities, may not be sufficient to commercialize baxdrostat or any other product candidate. Accordingly, we may be required to obtain further funding to achieve our business objectives.

Until such time, if ever, as we can generate substantial revenue, we expect to finance our cash needs through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. However, global economic conditions have been worsening, with disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide and rising inflation resulting from the effects of COVID-19, geopolitical events such as the conflict between Russia and Ukraine, including related sanctions, and otherwise. If these conditions persist and deepen, we could experience an inability to access additional capital, or our liquidity could otherwise be impacted. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs and/or future commercialization efforts. To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect our stockholders. Debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business.

If we raise funds through potential collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

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Contractual Obligations and Commitments

License Agreement Obligations

License agreement obligations relate to the Roche Agreement that we entered into with Roche in May 2019. Under the terms of the Roche Agreement, we obtained an exclusive, worldwide, royalty-bearing license to the Roche Technology to research, develop, register, use, make, import, export, market, distribute, sell (as well as the right to have each of the foregoing done) and otherwise exploit to a novel aldosterone synthase inhibitor compound, baxdrostat. Pursuant to the Roche Agreement, we paid Roche a one-time, upfront non-refundable license fee of $2.0 million and one $1.0 million milestone payment in connection with the completion of the multiple ascending dose Phase 1 clinical trial of baxdrostat. We are required to pay Roche certain tiered development event-based milestone payments, certain sales-based milestone payments, as well as a royalty from the future sales of Licensed Products. The royalty is tiered based on the combined net sales of each Licensed Product.

We are currently unable to estimate the timing or likelihood of achieving these clinical and commercial milestones or generating future product sales. See Note 4 to our condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for a description of our license agreement with Roche.

Purchase and Other Obligations

In the normal course of business, we enter into contracts with CROs and other third parties for conducting research and development activities, preclinical studies and clinical trials, research and development supplies and other testing and manufacturing services. The scope of the services under these contracts can be modified and provide for termination on notice, and therefore are cancellable contracts.

Critical Accounting Policies and Significant Judgments and Estimates

This management’s discussion and analysis is based on our condensed financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of the condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and related disclosures. On an ongoing basis, we evaluate our estimates and assumptions. Our estimates are based on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.

On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. The effects of material revisions in estimates, if any, will be reflected in the condensed financial statements prospectively from the date of change in estimates.

While our accounting policies are described in more detail in the notes to our condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, we believe the following accounting policies used in the preparation of our condensed financial statements require the most significant judgments and estimates. See Note 2 to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q for a description of our other significant accounting policies.

Prepaid and Accrued Research and Development Expenses

As part of the process of preparing our financial statements, we are required to estimate our prepaid and accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed. We make estimates of our prepaid and accrued research and development expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at the time. We confirm the accuracy of estimates with the service providers and make adjustments if necessary. Examples of estimated prepaid and accrued research and development expenses include expenses for:

•CROs in connection with clinical studies;

•investigative sites in connection with clinical studies;

•vendors in connection with preclinical development activities; and

•vendors related to product manufacturing, development and distribution of clinical materials.

We base our expenses related to clinical studies on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical studies on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. The scope of services under these contracts can be modified and some of the agreements may be cancelled by either party upon written notice. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical study milestones. In

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accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid accordingly.

Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed, we may report amounts that are too high or too low in any particular period. To date, there have been no material differences between our estimates and amounts actually incurred.

Stock-Based Compensation

The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718, Compensation – Stock Compensation (ASC 718). ASC 718 requires all stock-based payments to employees, including grants of employee stock options, to be recognized in the condensed statements of operations and comprehensive loss based on their fair values. The Company’s stock-based awards are subject only to service-based vesting conditions. The Company estimates the fair value of its stock-based awards using the Black-Scholes option pricing model, which requires the input of assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate, and (d) expected dividends.

Prior to the IPO, the Company based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The Company believes that the companies in the group have characteristics similar to its own characteristics, including stage of product development and a focus on the life sciences industry. The Company believes the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of the Company.

The Company uses the simplified method, as prescribed by the Securities and Exchange Commission (SEC) Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term for options granted and utilizes the contractual term for options granted. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of the stock options.

Compensation expense related to awards is calculated on a straight-line basis by recognizing the grant date fair value over the requisite service period of the award, which is generally the vesting term.

Emerging Growth Company Status and Smaller Reporting Company Status

We are an “emerging growth company,” or EGC, under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Section 107 of the JOBS Act provides that an EGC can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an EGC can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of the delayed adoption of new or revised accounting standards and, therefore, we will be subject to the same requirements to adopt new or revised accounting standards as private entities.

As an EGC, we may also take advantage of certain exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an EGC:

•we are presenting only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations in this Quarterly Report on Form 10-Q;

•we will avail ourselves of the exemption from providing an auditor’s attestation report on our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;

•we will avail ourselves of the exemption from complying with any requirement that may be adopted by the Public Company Accounting Oversight Board, or PCAOB, regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis;

•we are providing reduced disclosure about our executive compensation arrangements; and

•we will not require nonbinding advisory votes on executive compensation or stockholder approval of any golden parachute payments.

We will remain an EGC until the earliest of (i) December 31, 2027, (ii) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more, (iii) the date on which we have issued more than $1 billion in non-convertible debt during the previous rolling three-year period, or (iv) the date on which we are deemed to be a large accelerated filer under the Securities Exchange Act of 1934, as amended, or the Exchange Act.

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million.

If we are a smaller reporting company at the time we cease to be an EGC, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present

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only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to EGCs, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Recently Issued and Adopted Accounting Pronouncements

We do not expect that any recently issued accounting standards will have a material impact on our condensed financial statements or will otherwise apply to our operations.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required by this Item.

Item 4. Controls and Procedures.

Management’s Evaluation of our Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed in our reports under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. Management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

In connection with the preparation of this Quarterly Report on Form 10-Q, an evaluation was performed under the supervision and with the participation of our management, including our Chief Executive Officer and the Company’s Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of June 30, 2022. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded our disclosure controls and procedures are effective as of June 30, 2022, at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

During the quarter ended June 30, 2022, there have been no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) promulgated under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

Our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving the desired control objectives. Our management recognizes that any control system, no matter how well designed and operated, is based upon certain judgments and assumptions and cannot provide absolute assurance that its objectives will be met. Similarly, an evaluation of controls cannot provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

As of the date of this Quarterly Report on Form 10-Q, we are not involved in any material legal proceedings. However, from time to time, we could be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. In addition, we may, from time to time, make claims or take legal actions to assert our rights, including intellectual property rights, as well as claims relating to employment matters and the safety or efficacy of our products. Regardless of the outcome, legal proceedings can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. Additionally, any such claims, whether or not successful, could damage our reputation and business.

Item 1A. Risk Factors.

Our business is subject to numerous risks, including the risks previously disclosed in Item 1A, subsection “Risk Factors” to Part I, Item 1A of our 2021 Annual Report on Form 10-K filed with the SEC on March 22, 2022, or the Annual Report. The occurrence of any of the events or developments described in the Annual Report could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of our common stock could decline and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

In addition to the risks described in our Annual Report, you should carefully consider the other information set forth in this Form 10-Q and the information in our other filings with the SEC, as they could materially affect our business, financial condition or future results of operations. There were no material changes during the period covered in this Form 10-Q to the risk factors previously disclosed in Part I, Item 1A of the Annual Report

32

Our portfolio of marketable securities is subject to market, interest and credit risk that may reduce its value.

We maintain a portfolio of marketable securities. Changes in the value of our portfolio of marketable securities could adversely affect our earnings. In particular, the value of our investments may decline due to increases in interest rates, downgrades of the bonds and other securities included in our portfolio, instability in the global financial markets that reduces the liquidity of securities included in our portfolio, declines in the value of collateral underlying the securities included in our portfolio and other factors. In addition, the ongoing COVID-19 pandemic, macroeconomic conditions, such as rising inflation and supply chain disruptions, and the ongoing military conflict between Ukraine and Russia and related sanctions against Russia have and may continue to have an adverse effect on the financial markets in some or all countries worldwide. Each of these events may cause us to record charges to reduce the carrying value of our investment portfolio or sell investments for less than our acquisition cost. Although we attempt to mitigate these risks through diversification of our investments and continuous monitoring of our portfolio’s overall risk profile, the value of our investments may nevertheless decline.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

(a) Recent Sales of Unregistered Equity Securities

None.

(b) Use of Proceeds from Initial Public Offering of Common Stock

On January 11, 2022, we completed the IPO of our common stock pursuant to which we issued and sold 12,100,000 shares of our common stock at a price to the public of $16.00 per share. On February 8, 2022, we issued and sold an additional 1,190,813 shares of our common stock at a price to the public of $16.00 per share pursuant to a partial exercise of the underwriters’ over-allotment option.

All of the shares issued and sold in the IPO were registered under the Securities Act pursuant to a Registration Statement on Form S-1 (File No 333-261738), which was declared effective on January 6, 2022.

The aggregate net proceeds to us from the IPO, inclusive of proceeds from the over-allotment exercise, were approximately $193.6 million after deducting underwriting discounts and commissions of $14.9 million and offering expenses of approximately $4.5 million.

There has been no material change in our planned use of the net proceeds from the IPO as described in our prospectus filed pursuant to Rule 424(b)(4) under the Securities Act with the U.S. Securities and Exchange Commission, or SEC on January 7, 2022.

(c) Issuer Purchases of Equity Securities

None.

Item 3. Defaults Upon Senior Securities.

Not applicable.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

None.

Item 6. Exhibits.

33

Exhibit Number	Description
3.1	Amended and Restated Certificate of Incorporation of the Registrant (filed as Exhibit 3.1 to Registrant's Current Report on Form 8-K, filed with the SEC on January 11, 2022, and incorporated by reference herein).
3.2	Amended and Restated Bylaws of the Registrant (filed as Exhibit 3.2 to Registrant's Current Report on Form 8-K, filed with the SEC on January 11, 2022, and incorporated by reference herein).
31.1*	Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*	Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1+*	Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS	Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.
101.SCH	Inline XBRL Taxonomy Extension Schema Document
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

* Filed herewith.

+ This certification is being furnished solely to accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	Company Name
Date: August 8, 2022	By:	/s/ Marc de Garidel
		Marc de Garidel
		Chief Executive Officer (Principal Executive Officer)
Date: August 8, 2022	By:	/s/ Mary Theresa Coelho
		Mary Theresa Coelho
		EVP, Chief Financial Officer and Chief Business Development Officer (Principal Financial Officer and Principal Accounting Officer)

34

EX-31.1

Exhibit 31.1

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Marc de Garidel, certify that:

1.I have reviewed this Quarterly Report on Form 10-Q of CinCor Pharma, Inc (the "registrant");

2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(c)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date: August 8, 2022	By:	/s/ Marc de Garidel
		Marc de Garidel
		Chief Executive Officer

EX-31.2

Exhibit 31.2

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Mary Theresa Coelho, certify that:

1.I have reviewed this Quarterly Report on Form 10-Q of CinCor Pharma, Inc. (the 'registrant");

2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(c)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date: August 8, 2022	By:	/s/ Mary Theresa Coelho
		Mary Theresa Coelho
		EVP, Chief Financial Officer and Chief Business Development Officer

EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the "Exchange Act") and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), Marc de Garidel, President and Chief Executive Officer of CinCor Pharma, Inc. (the "Company"), and Mary Theresa Coelho, Chief Financial Officer and Chief Business Development Officer of the Company, each hereby certifies that, to the best of his/her knowledge:

(1)The Company's Quarterly Report on Form 10-Q for the period ending June 30, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”) fully complies with the requirements of section 13(a) or 15(d) of the Exchange Act; and

(2)The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

Date: August 8, 2022	By:	/s/ Marc de Garidel
		Marc de Garidel
		Chief Executive Officer
		(Principal Executive Officer)
		/s/ Mary Theresa Coelho
		Mary Theresa Coelho
		EVP, Chief Financial Officer and Chief Business Development Officer
		(Principal Financial Officer and Principal Accounting Officer)

XML

Document And Entity Information - shares	6 Months Ended
	Jun. 30, 2022	Aug. 08, 2022
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Jun. 30, 2022
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q2
Trading Symbol	CINC
Entity Registrant Name	CinCor Pharma, Inc.
Entity Central Index Key	0001868734
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Shell Company	false
Title of 12(b) Security	Common Stock, $0.00001 par value per share
Security Exchange Name	NASDAQ
Entity File Number	001-41201
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	36-4931245
Entity Address, Address Line One	230 Third Avenue,
Entity Address, City or Town	Waltham
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02451
City Area Code	844
Local Phone Number	531-1834
Document Transition Report	false
Document Quarterly Report	true
Entity Common Stock Shares Outstanding		37,739,323

XML

Condensed Balance Sheets - USD ($)	Jun. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 127,619,608	$ 136,605,613
Marketable securities	166,692,295	0
Prepaid research and development contracts	7,482,503	1,769,074
Prepaid expenses and other current assets	1,180,696	2,731,953
Total current assets	302,975,102	141,106,640
Long term assets:
Property, Plant and Equipment, Net, Total	40,731	0
Assets, Noncurrent, Total	40,731	0
Total assets	303,015,833	141,106,640
Current liabilities:
Accounts payable	2,095,374	642,143
Related-party accounts payable	0	7,323
Warrant derivative liabilities	0	10,636,921
Accrued legal expenses	349,943	2,104,766
Accrued research and development contracts	3,230,997	1,751,530
Accrued expenses and other liabilities	1,605,560	1,406,506
Total current liabilities	7,281,874	16,549,189
Stockholders' equity (deficit):
Common stock, $0.00001 par value per share; 95,000,000 and 13,731,721 shares authorized, and 37,709,912 and 2,557,341 outstanding at June 30, 2022, and December 31, 2021, respectively	378	26
Additional paid-in capital	411,920,723	13,986,033
Accumulated deficit	(115,475,376)	(77,703,069)
Accumulated other comprehensive loss	(711,766)	0
Total stockholders equity (deficit)	295,733,959	(63,717,010)
Total liabilities, redeemable convertible preferred stock, and stockholders equity (deficit)	303,015,833	141,106,640
Series A Redeemable Convertible Preferred Stock [Member]
Current liabilities:
Redeemable convertible preferred stock	0	47,173,259
Series B Redeemable Convertible Preferred Stock [Member]
Current liabilities:
Redeemable convertible preferred stock	$ 0	$ 141,101,202

XML

Condensed Balance Sheets (Parenthetical) - $ / shares	Jun. 30, 2022	Dec. 31, 2021
Common stock, par value per share	$ 0.00001	$ 0.00001
Common stock, shares authorized	95,000,000	13,731,721
Common stock, shares outstanding	37,709,912	2,557,341
Series A Redeemable Convertible Preferred Stock [Member]
Temporary equity, par value	$ 0.00001	$ 0.00001
Temporary equity, shares authorized	0	35,714,282
Temporary equity, shares outstanding	0	35,714,282
Series B Redeemable Convertible Preferred Stock [Member]
Temporary equity, par value	$ 0.00001	$ 0.00001
Temporary equity, shares authorized	0	35,716,249
Temporary equity, shares outstanding	0	35,716,249

XML

Condensed Statements of Operations - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Operating expenses
Research and development	$ 17,161,014	$ 3,998,391	$ 26,851,612	$ 7,487,821
General and administrative	4,191,767	1,176,018	8,205,513	2,099,583
Total operating expenses	21,352,781	5,174,409	35,057,125	9,587,404
Loss from operations	(21,352,781)	(5,174,409)	(35,057,125)	(9,587,404)
Other (income) expense:
Interest income	(277,377)	(1,539)	(328,825)	(5,952)
Change in fair value of warrant derivative liabilities		1,209,829	3,044,006	2,419,657
Total other (income) expense, net	(277,377)	1,208,290	2,715,181	2,413,705
Net loss	$ (21,075,404)	$ (6,382,699)	$ (37,772,306)	$ (12,001,109)
Net and comprehensive loss per share attributable to common stockholders, basic and diluted
Net and comprehensive loss per share attributable to common stockholders, basic and diluted	$ (0.56)	$ (4.81)	$ (1.06)	$ (9.31)
Weighted average number of common shares used in computing net loss per share attributable to common stockholders, basic and diluted	37,709,912	1,327,852	35,583,567	1,289,141

XML

Condensed Statements of Comprehensive Loss - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Statement Of Income And Comprehensive Income [Abstract]
Net loss	$ (21,075,404)	$ (6,382,699)	$ (37,772,306)	$ (12,001,109)
Other comprehensive loss:
Unrealized losses on available-for-sale securities	(394,155)	0	(711,766)	0
Comprehensive loss	$ (21,469,559)	$ (6,382,699)	$ (38,484,072)	$ (12,001,109)

XML

Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Deficit - USD ($)	Total	Common Stock [Member]	Additional Paid-in Capital [Member]	AOCI Attributable to Parent [Member]	Retained Earnings [Member]	Series A Redeemable Convertible Preferred Stock [Member]	Series B Redeemable Convertible Preferred Stock [Member]
Temporary equity balance, Value at Dec. 31, 2020						$ 47,173,259
Temporary equity balance, Shares at Dec. 31, 2020						35,714,282
Balance at Dec. 31, 2020	$ (27,264,652)	$ 13	$ 69,330		$ (27,333,995)
Balance, Shares at Dec. 31, 2020		1,250,000
Stock-based compensation	1,389,955		1,389,955
Net loss	(5,618,411)				(5,618,411)
Temporary equity balance, Value at Mar. 31, 2021						$ 47,173,259
Temporary equity balance, Shares at Mar. 31, 2021						35,714,282
Balance at Mar. 31, 2021	(31,493,108)	$ 13	1,459,285		(32,952,406)
Balance, Shares at Mar. 31, 2021		1,250,000
Temporary equity balance, Value at Dec. 31, 2020						$ 47,173,259
Temporary equity balance, Shares at Dec. 31, 2020						35,714,282
Balance at Dec. 31, 2020	(27,264,652)	$ 13	69,330		(27,333,995)
Balance, Shares at Dec. 31, 2020		1,250,000
Other comprehensive loss	0
Temporary equity balance, Value at Jun. 30, 2021						$ 47,173,259
Temporary equity balance, Shares at Jun. 30, 2021						35,714,282
Balance at Jun. 30, 2021	(36,349,158)	$ 14	2,985,933	$ 0	(39,335,105)
Balance, Shares at Jun. 30, 2021		1,392,636
Temporary equity balance, Value at Mar. 31, 2021						$ 47,173,259
Temporary equity balance, Shares at Mar. 31, 2021						35,714,282
Balance at Mar. 31, 2021	(31,493,108)	$ 13	1,459,285		(32,952,406)
Balance, Shares at Mar. 31, 2021		1,250,000
Stock options exercised	1,232,800	$ 1	1,232,799
Stock options exercised, shares		142,636
Stock-based compensation	293,849		293,849
Other comprehensive loss	0
Net loss	(6,382,699)				(6,382,699)
Temporary equity balance, Value at Jun. 30, 2021						$ 47,173,259
Temporary equity balance, Shares at Jun. 30, 2021						35,714,282
Balance at Jun. 30, 2021	(36,349,158)	$ 14	2,985,933	0	(39,335,105)
Balance, Shares at Jun. 30, 2021		1,392,636
Temporary equity balance, Value at Dec. 31, 2021						$ 47,173,259	$ 141,101,202
Temporary equity balance, Shares at Dec. 31, 2021						35,714,282	35,716,249
Balance at Dec. 31, 2021	(63,717,010)	$ 26	13,986,033		(77,703,069)
Balance, Shares at Dec. 31, 2021		2,557,341
Issuance of common stock	193,550,726	$ 133	193,550,593
Issuance of common stock, shares		13,290,813
Conversion of preferred stock in connection with the initial public offering	188,274,343	$ 210	188,274,133			$ (47,173,259)	$ (141,101,202)
Conversion of preferred stock in connection with the initial public offering, shares		21,008,970				(35,714,282)	(35,716,249)
Automatic conversion of the Roche warrants	13,644,608	$ 9	13,644,599
Automatic conversion of the Roche warrants, shares		852,788
Stock-based compensation	1,224,208		1,224,208
Other comprehensive loss	(317,611)			(317,611)
Net loss	(16,696,903)				(16,696,903)
Balance at Mar. 31, 2022	315,962,361	$ 378	410,679,566	(317,611)	(94,399,972)
Balance, Shares at Mar. 31, 2022		37,709,912
Temporary equity balance, Value at Dec. 31, 2021						$ 47,173,259	$ 141,101,202
Temporary equity balance, Shares at Dec. 31, 2021						35,714,282	35,716,249
Balance at Dec. 31, 2021	(63,717,010)	$ 26	13,986,033		(77,703,069)
Balance, Shares at Dec. 31, 2021		2,557,341
Other comprehensive loss	(711,766)
Temporary equity balance, Value at Jun. 30, 2022						$ 0	$ 0
Temporary equity balance, Shares at Jun. 30, 2022						0	0
Balance at Jun. 30, 2022	295,733,959	$ 378	411,920,723	(711,766)	(115,475,376)
Balance, Shares at Jun. 30, 2022		37,709,912
Balance at Mar. 31, 2022	315,962,361	$ 378	410,679,566	(317,611)	(94,399,972)
Balance, Shares at Mar. 31, 2022		37,709,912
Stock-based compensation	1,241,157		1,241,157
Other comprehensive loss	(394,155)			(394,155)
Net loss	(21,075,404)				(21,075,404)
Temporary equity balance, Value at Jun. 30, 2022						$ 0	$ 0
Temporary equity balance, Shares at Jun. 30, 2022						0	0
Balance at Jun. 30, 2022	$ 295,733,959	$ 378	$ 411,920,723	$ (711,766)	$ (115,475,376)
Balance, Shares at Jun. 30, 2022		37,709,912

XML

Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Deficit (Parenthetical)	3 Months Ended
	Mar. 31, 2022 USD ($)
Common Stock [Member]
Net of underwriting, discounts and commissions costs	$ 19,420,580

XML

Condensed Consolidated Statements of Cash Flows - USD ($)	3 Months Ended		6 Months Ended		12 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021	Dec. 31, 2021
Operating activities:
Net loss	$ (21,075,404)	$ (6,382,699)	$ (37,772,306)	$ (12,001,109)
Adjustments to reconcile net and comprehensive loss to net cash used in operating activities:
Stock-based compensation			2,465,365	1,802,906
Change in fair value of warrant derivative liabilities		1,209,829	3,044,006	2,419,657
Accretion of discounts on available for sale securities			(178,383)
Depreciation			1,405
Changes in operating assets and liabilities:
Prepaid research and development contracts			(5,713,429)	(2,042,900)
Prepaid expenses and other current assets			(1,074,117)	(236,041)
Accounts payable			1,416,124	(2,379,671)
Related-party accounts payable			(7,323)	36,354
Accrued expenses and other liabilities			552,364	(1,181,459)
Net cash used in operating activities			(37,266,294)	(13,582,263)
Investing activities:
Purchases of investment securities			(227,225,678)
Maturities of investment securities			60,000,000
Purchase of fixed assets			(42,136)
Net cash used in investing activities			(167,267,814)
Financing activities:
Proceeds from issuance of common stock			197,767,310
Issuance costs for initial public offering			(2,219,207)
Proceeds From Stock Options Exercise				1,232,799
Net cash provided by financing activities			195,548,103	1,232,799
Net increase (decrease) in cash and cash equivalents			(8,986,005)	(12,349,464)
Cash and cash equivalents at beginning of period			136,605,613	26,078,064	$ 26,078,064
Cash and cash equivalents at end of period	127,619,608	13,728,600	127,619,608	13,728,600	$ 136,605,613
Supplemental disclosures for non-cash financing activities
Conversion of redeemable convertible preferred stock into common stock upon initial public offering	$ 188,274,133		$ 188,274,133
Automatic conversion of the Roche warrants into common stock upon initial public offering	13,644,608		13,644,608

XML

Condensed Consolidated Statements of Cash Flows (Parenthetical) $ in Millions	Jun. 30, 2022 USD ($)
Statement Of Cash Flows [Abstract]
Cash And Cash Equivalents And Excludes Marketable Securities	$ 166.7
Cash, Cash equivalents and Marketable Securities	$ 294.3

XML

Nature of Organization and Operations

6 Months Ended

Jun. 30, 2022

Organization Consolidation And Presentation Of Financial Statements [Abstract]

Nature of Organization and Operations

1. Nature of Organization and Operations

CinCor Pharma, Inc. (the “Company”) is a clinical-stage biopharmaceutical company focused on developing its lead clinical candidate, baxdrostat, for the treatment of hypertension and other cardio-renal diseases. Baxdrostat is a highly selective, oral small molecule inhibitor of aldosterone synthase, the enzyme responsible for the synthesis of aldosterone in the adrenal gland. The Company is conducting multiple Phase 2 clinical trials using baxdrostat in differing populations of patients, all of whom are hypertensive.

The Company was incorporated in March 2018 and founded as a subsidiary of CinRx Pharma, LLC (“CinRx”), a biotechnology company focused on developing novel therapeutics. In May 2019, the Company entered into an agreement with F. Hoffmann-La Roche Ltd and Hoffmann La-Roche Inc. (collectively, “Roche”) for an exclusive, worldwide, royalty-bearing license to certain Roche technology to

research, develop, manufacture, and commercialize a novel aldosterone synthase inhibitor compound, baxdrostat, for any and all diseases and conditions. In connection with the in-licensing transaction with Roche, the Company was spun out as an independent company.

The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, possible failure of preclinical studies or clinical trials, the need to obtain marketing approval for its product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, the need to successfully commercialize and gain market acceptance of any of the Company’s products that are approved and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing, and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.

Initial Public Offering and Liquidity

On January 11, 2022, the Company completed an initial public offering (the "IPO") of its common stock pursuant to which the Company issued and sold 13,290,813 shares of common stock at a price to the public of $16.00 per share. The aggregate net proceeds from the IPO were approximately $193.6 million after deducting underwriting discounts and commissions of $14.9 million and offering expenses of approximately $4.5 million. Upon completion of the IPO, all outstanding shares of Series A and Series B redeemable convertible preferred stock converted to 21,008,970 shares of common stock at a ratio of 3.4:1. In addition, the IPO also resulted in the automatic net exercise of the three outstanding warrants to purchase common stock issued to Roche for an aggregate of 852,788 shares of common stock (collectively, the “Roche Warrants”).

The Company incurred significant losses from operations and had negative cash flows from operating activities for the three and six months ended June 30, 2022 and 2021, and since inception. The Company’s current operating plan indicates it will continue to incur losses from operations and generate negative cash flows from operating activities, given ongoing expenditures related to extensive research and development and the Company’s lack of revenue-generating activities at this point in the Company’s life cycle.

The Company expects that its existing cash, cash equivalents and marketable securities is sufficient to fund its operating expenses and capital expenditure requirements through 2024, including completing all of its ongoing Phase 2 trials, its currently planned Phase 3 clinical program in hypertension, CMC development and GMP batch production, and the additional activities needed to complete its planned new drug application submission. The future viability of the Company beyond that point is dependent on its ability to raise additional capital to fund its operations.

If the Company is unable to obtain future funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations.

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Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2022

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Basis of Presentation

The unaudited condensed financial statements have been prepared in accordance with U.S. Securities and Exchange Commission (“SEC”) regulations and include all of the information and disclosures required by U.S. generally accepted accounting principles (“U.S. GAAP” or “GAAP”) for interim financial reporting, and, in the opinion of management include all adjustments necessary for a fair presentation of the condensed financial statements for each period presented. All adjustments are normal and recurring in nature. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). These unaudited condensed financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2021 in the Company’s Annual Report on Form 10-K filed with the SEC on March 22, 2022. The results of operations for the interim periods are not necessarily indicative of results of operations for a full year. The Company’s condensed financial statements are stated in U.S. Dollars.

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment. All the assets and operations of the Company’s sole operating segment are located in the United States.

Use of Estimates

The preparation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the

condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls and in developing the estimates and assumptions that are used in the preparation of these condensed financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates have been or are used in the following areas, among others: prepaid research and development contracts, fair value of the Company's common stock prior to the IPO, fair value of warrant derivative liabilities, stock compensation expense and income taxes.

Prior to its IPO, the Company utilized estimates and assumptions in determining the fair value of its common stock. The Company has granted stock options at exercise prices that represented the fair value of its common stock on grant date. The Company utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation, to estimate the fair value of its common stock prior to its IPO. Each valuation methodology includes estimates and assumptions that require the Company's judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of redeemable convertible preferred stock, the superior rights and preferences of the redeemable convertible preferred stock senior to the Company's common stock at the time, and a probability analysis of various liquidity events at that time, such as a public offering or sale of the Company, under differing scenarios. Changes to the key assumptions used in the valuations could have resulted in different fair values of common stock at each valuation date.

The Company's results and business operations can also be affected or disrupted by economic, political, legislative, health concerns, such as the COVID-19 pandemic, regulatory, legal actions and geopolitical events, such as the ongoing military conflict between Ukraine and Russia and the related sanctions against Russia. Economic conditions, such as recessionary trends, inflation, interest, changes in regulatory laws and monetary exchange rates, and government fiscal policies, can also have a significant effect on operations. In addition, the conflict between Russia and Ukraine and related sanctions has had significant ramifications on global financial markets, including volatility in the U.S. and global financial markets, which has led to disruptions to trade, commerce, pricing stability, credit availability, supply chain continuity and reduced access to liquidity globally, and has caused and may continue to cause volatility in the price of our common stock, which may adversely impact our ability to raise capital on favorable terms or at all. The full economic and social impact of the sanctions imposed on Russia and possible future punitive measures that may be implemented, as well as the counter measures imposed by Russia, in addition to the ongoing military conflict between Ukraine and Russia remains uncertain; however, both the conflict and related sanctions have resulted and could continue to result in disruptions to trade, commerce, pricing stability, credit availability, supply chain continuity and reduced access to liquidity on acceptable terms, in both Europe and globally, and has introduced significant uncertainty into global markets. As a result, our business and results of operations may be adversely affected by the ongoing conflict between Ukraine and Russia and related sanctions, particularly to the extent it escalates to involve additional countries, further economic sanctions or wider military conflict. While the Company maintains reserves for anticipated liabilities, the Company could be affected by civil, criminal, regulatory, or administrative actions, claims, or proceedings. The extent to which the Company’s business can be impacted by future events is highly uncertain and cannot be predicted at this time.

Concentration of Credit Risk and Other Risks and Uncertainties

The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements. Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash and cash equivalents, which consist of money market funds that invest primarily in short­ term U.S. government securities and short-term marketable securities that are primarily invested in fixed income securities.

The Company has not yet generated any revenue from the sale of its products and is subject to all of the risks and uncertainties that are typically faced by biopharmaceutical companies that devote substantially all of their efforts to research and development and clinical trials and do not yet have commercial products. The Company expects to continue incurring losses for the foreseeable future.

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include cash held in banks and amounts held primarily in interest-bearing money market accounts. Cash equivalents are carried at cost, which approximates their fair market value.

Marketable Securities

The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each condensed balance sheet date. The Company classified all of its marketable securities at December 31, 2021 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value with the unrealized gains and losses included in other comprehensive loss as a component of stockholders’ equity (deficit) until realized. Any premium or discount arising at purchase is amortized or accreted to interest income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are

included in other (income) expense, net. There were no material realized gains or losses on marketable securities recognized for the three and six months ended June 30, 2022 or 2021.

Initial Public Offering Costs

Costs directly attributable to the Company’s IPO which were incurred in 2021 were deferred and capitalized as prepaid expenses and other current assets at December 31, 2021. These costs primarily represented legal, underwriting and accounting costs related to the Company’s efforts to raise capital through a public sale of its common stock. Any additional costs incurred during the six months ended June 30, 2022 were deferred until the completion of the IPO, which occurred on January 11, 2022, at which time they were reclassified to additional paid in capital as a reduction of the IPO gross proceeds. At December 31, 2021, the Company had capitalized $2.6 million of deferred IPO costs, as prepaid expenses and other current assets. A total of $4.5 million of IPO issuance costs were incurred through January 11, 2022, which were recorded as a reduction of the IPO gross proceeds and included the $2.6 million previously capitalized in 2021.

Redeemable Convertible Preferred Stock

In accordance with ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480”), preferred stock issued with redemption provisions that are outside of the control of the issuer or that contain certain redemption features in a Deemed Liquidation Event (as defined in our Amended and Restated Certificate of Incorporation) is required to be presented outside of stockholders' equity (deficit) on the face of the condensed balance sheet and certain disclosures are required to be included in the notes to the condensed financial statements. If required, changes in fair value are recorded as additional paid in capital and/or accumulated deficit in the condensed balance sheets. Changes in fair value that would reduce the fair value of the redeemable convertible preferred stock below the original issue price are limited so that the value of the shares are not recorded below the original issue price.

Fair Value Measurements

Financial assets and liabilities are recorded at fair value. The carrying amount of certain financial instruments, including accounts payable and other current liabilities approximate fair value due to their relatively short maturities. Assets and liabilities recorded at fair value on a recurring basis in the condensed balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:

Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;

Level 2—Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and

Level 3—Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data.

Where quoted prices are available in an active market, assets or liabilities are classified as Level 1.

To the extent that a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument's level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. There were no transfers within the fair value hierarchy in 2022 and 2021.

Research and Development

The Company charges all research and development costs, both internal and external, to expense when incurred. Costs are considered incurred based on an evaluation of the progress to completion of specific tasks under each contract using information and data provided to the Company by its clinical sites and vendors. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company. The Company's research and development expenses consist primarily of clinical trial expenses, consulting costs and stock-based compensation, and costs associated with required regulatory filings, licenses, and fees.

Stock-Based Compensation

The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718, Compensation – Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, including grants of employee stock options and restricted stock units, to be recognized in the statements of operations based on their fair values. The Company’s stock-based awards are subject only to service-based vesting conditions. The Company estimates the fair value of its stock-based awards in the form of employee stock options, using the Black-Scholes option pricing model, which requires the input of assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends.

Prior to its IPO, the Company had based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The computation of expected volatility is based on the historical volatility of a representative group of companies

with similar characteristics to the Company, including stage of product development and life science industry focus. The Company believes the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of the Company.

The Company uses the simplified method as prescribed by the SEC Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term for options granted to employees and utilizes the contractual term for options granted to non-employees. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of the stock options.

Compensation expense related to awards to employees is calculated on a straight-line basis by recognizing the grant date fair value over the associated service period of the award, which is generally the vesting term.

Derivative Instruments, Including Warrant Derivative Liabilities

The Company accounts for derivatives, specifically freestanding detachable stock purchase warrants, in accordance with ASC Topic 815, Derivatives and Hedging ("ASC 815"). This guidance establishes accounting and reporting principles for derivative instruments, including certain derivative instruments embedded in other contracts.

Net Loss Per Share

The Company's basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share attributable to common stockholders is computed by giving effect to all potential common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, redeemable convertible preferred stock prior to the Company's IPO and stock options to purchase common stock are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share attributable to common stockholders as their effect is anti-dilutive.

Income Taxes

Income taxes are recorded in accordance with ASC Topic 740, Income Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the condensed financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the condensed financial statement and tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates anticipated to be in effect for the year in which the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all the deferred tax assets will not be realized.

The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that some or all the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. As of June 30, 2022, and December 31, 2021, the Company does not have any significant uncertain tax positions. If the Company were to incur interest and penalties on uncertain tax positions, it would classify them as income tax expense.

The Company files U.S. federal and state income tax returns.

The Company did not record a current or deferred income tax expense or benefit for the three and six months ended June 30, 2022 and 2021, due to the Company’s net and comprehensive losses and increases in its deferred tax asset valuation allowance.

Comprehensive Loss

Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. For the three and six months ended June 30, 2022, the Company’s only element of other comprehensive loss was unrealized losses on available-for-sale securities. Comprehensive loss for the three and six months ended June 30, 2021, equaled net loss for those periods.

Litigation and Other Contingencies

The Company may be subject to legal proceedings and claims arising from the ordinary course of its business, including contract and employment claims. U.S. GAAP requires that a liability for contingencies be recorded when it is probable that a liability has occurred, and the amount of the liability can be reasonably estimated. In the opinion of management, the aggregate liability, if any, with respect to such ordinary course of business actions will not have a material adverse effect on the financial position or results of operations of the Company.

Reverse Stock Split

On December 30, 2021, the Company’s Board of Directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 3.4-for-1 reverse stock split of the Company’s common stock, which was effected on December 30, 2021. Stockholders entitled to fractional shares as a result of the reverse stock split received a cash payment in lieu of receiving fractional shares. The par value of the common stock was not adjusted as a result of the reverse stock split. Shares of common stock underlying outstanding stock options and other equity instruments were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the appropriate securities agreements. Shares of common stock reserved for issuance upon the conversion of our convertible preferred stock were proportionately reduced and the respective conversion prices were proportionately increased. All common share and per share data have been retrospectively revised including the three and six months ended June 30, 2021, to reflect the reverse stock split.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

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Fair Value of Measurements

6 Months Ended

Jun. 30, 2022

Fair Value Disclosures [Abstract]

Fair Value of Measurements

3. Fair Value of Measurements

The following table represents the financial instruments measured at fair value on a recurring basis based on the fair value hierarchy at:

	June 30, 2022
	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	127,619,608	$	—	$	—	$	127,619,608
Marketable securities:
US Treasury bills		74,612,727		—		—		74,612,727
Certificate of deposit		42,587,053		—		—		42,587,053
US Government agency securities		—		49,492,515		—		49,492,515
Total assets at fair value	$	244,819,388	$	49,492,515	$	—	$	294,311,903
	December 31, 2021
	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	136,605,613	$	—	$	—	$	136,605,613
Total assets at fair value	$	136,605,613	$	—	$	—	$	136,605,613
Liabilities:
Warrant derivative liabilities	$	—	$	—	$	10,636,921	$	10,636,921
Total liabilities at fair value	$	—	$	—	$	10,636,921	$	10,636,921

The amortized cost basis of marketable securities as of June 30, 2022 was $182.4 million.

The fair value of money market funds, U.S. Treasury bills and certificates of deposits are based on unaudited quoted market prices, which are considered Level 1 inputs in the fair value hierarchy. Level 2 assets consists of U.S. Government agency securities and are based upon quoted market prices for similar securities in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third-party data providers, including but not limited to, benchmark yields, interest rate curves, reported trades, broker/dealer quotes and reference data.

The following table sets forth a summary of changes in the fair value of the warrant derivative liabilities, representing a recurring measurement that is classified within Level 3 of the fair value hierarchy:

January 1, 2022	$	10,636,921
Change in fair value of warrant derivative liabilities		3,044,006
Automatic conversion of Roche warrants into common stock upon initial public offering		(13,680,927	)
June 30, 2022	$	-

The Company estimated the fair value of the warrant derivative liabilities using a Black-Scholes option pricing model. The valuation model used the following assumptions at December 31, 2021:

	December 31,
	2021
Fair value of common stock	$	12.44
Volatility		64.00	%
Expected term (in years)		0.52
Risk-free interest rate		0.21	%
Dividend yield		—

The preceding methods described may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Furthermore, although the Company believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value could result in a different fair value measurement at the reporting date.

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License Agreement

6 Months Ended

Jun. 30, 2022

License Agreement Disclosure [Abstract]

License Agreement

4. License Agreement

In May 2019, the Company entered into a license agreement (“Roche Agreement”) with Roche, pursuant to which the Company obtained an exclusive, worldwide, royalty-bearing license under certain patents and specified know-how owned or controlled by Roche and covering certain specified small molecule aldosterone synthase inhibitors (“Roche Technology”) to research, develop and commercialize products containing such aldosterone synthase inhibitors (“Licensed Products”) for any and all uses, including the treatment, prevention or diagnosis of any and all diseases and medical conditions in humans and animals. Pursuant to the Roche Agreement, the Company paid Roche a one-time, upfront non-refundable license fee of $2.0 million. Additionally, the Company is required to pay Roche certain regulatory event-based milestone payments, certain one time sales-based milestone payments, as well as tiered royalty payments based on the net sales of the Licensed products.

The Roche Agreement will expire, unless earlier terminated by either party, upon expiration of all royalty or other payment obligations under the Roche Agreement are or will become due. For the three months ended June 30, 2022 and 2021, the Company recorded non-cash expense of $0.0 million and $1.2 million, respectively and $3.0 million and $2.4 million, for the six months ended June 30, 2022 and 2021, respectively, related to the Roche Agreement on the Company’s condensed statements of operations.

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Redeemable Convertible Preferred Stock

6 Months Ended

Jun. 30, 2022

Equity [Abstract]

Redeemable Convertible Preferred Stock

5. Redeemable Convertible Preferred Stock

Series A Redeemable Convertible Preferred Stock

In May 2019, the Company authorized the issuance of 35,714,282 shares to be issued in the form of Series A redeemable convertible preferred stock (“Series A preferred stock”). The Company issued 35,714,282 shares of Series A preferred stock at $1.40 per share for total proceeds of $50 million. The Company incurred $2.1 million of Series A preferred stock issuance costs, which was recorded against the carrying amount of the Series A preferred stock as of December 31, 2021. The rights, preferences, and privileges of the Company’s Series A preferred stock prior to IPO were as follows:

Voting

Up until the IPO, the holders of Series A preferred stock were entitled to a number of votes equal to the number of whole shares of common stock into which the shares of Series A preferred stock were convertible. Except as provided by law or otherwise, the holders of the Series A preferred stock vote together with the holders of common stock as a single class.

Up until the IPO, the holders of Series A preferred stock, voting as a separate class, were entitled to elect three members of the Board of Directors. The holders of the common stock, voting as a separate class, were entitled to elect two members of the Board of Directors. The holders of Series A preferred stock and common stock, voting together as a single class on an as-converted basis, are entitled to elect any additional members of the Board of Directors.

Dividends

Dividends were payable, if permitted by law, in accordance with the Series A preferred stock terms if and when declared by the Board of Directors. Holders of the Series A preferred stock were entitled to receive dividends out of any assets at the time legally available, at the applicable dividend rate specified for such shares of the Series A preferred stock. Dividends were not mandatory and were not cumulative. No dividends were declared or paid since inception of the Company.

Liquidation

In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holders of shares of the Series A preferred stock then outstanding were entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a Deemed Liquidation Event, out of the consideration payable to stockholders in such an event, before any payment shall be made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the Series A preferred

stock original issue price, plus any dividends declared but unpaid. If upon any such liquidation, dissolution, or winding up of the Company or a Deemed Liquidation Event, the assets of the Company available for distribution to its stockholders are insufficient to pay the holders of shares of Series A preferred stock the full amount to which they were entitled, the holders of shares of the Series A preferred stock share ratably in any distribution of the assets available for distribution in proportion to the respective amounts that would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

The remaining available proceeds would be distributed pro rata among the holders of the shares of the Series A preferred stock and common stock, based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted to common stock pursuant to the applicable terms immediately prior to such liquidation, dissolution, or winding up of the Company.

Conversion

Each share of the Series A preferred stock was convertible, at the option of the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of common stock as determined by dividing the Series A preferred stock original issue price by the Series A preferred stock conversion price in effect at the time of conversion. The applicable conversion price was subject to future adjustments upon the occurrence of certain events. However, holders of the Series A preferred stock did not have the right to convert any shares of the Series A preferred stock at the applicable conversion ratio in effect for preferred shares upon either (i) the closing of a qualified initial public offering of its common stock at a price per share of at least $14.28 per share (subject to adjustment for any share split, combination or dividend or distribution payable) resulting in at least $50 million in gross proceeds to the Company net of the underwriting discount and commissions, or (ii) the election to convert the preferred shares by at least two of the following three holders of the Company’s Series A preferred stock: (i) Sofinnova Venture Partners X, L.P., (ii) Sofinnova Capital IX and (iii) 5AM Ventures VI, L.P.

The Company evaluated the Series A preferred stock and determined that it was considered an equity host under ASC 815. In making this determination, the Company’s analysis followed the whole instrument approach, which compares an individual feature against the entire Series A preferred stock instrument that includes that feature. The Company’s analysis was based on a consideration of the economic characteristics and risks of the Series A preferred stock. More specifically, the Company evaluated all of the stated and implied substantive terms and features, including (i) whether the Series A preferred stock included redemption features, (ii) how and when any redemption features could be exercised, (iii) whether the holders of the Series A preferred stock were entitled to dividends, (iv) the voting rights of the Series A preferred stock, and (v) the existence and nature of any conversion rights. The Company concluded that, as the Series A preferred stock represents an equity host, the conversion feature included in the Series A preferred stock is clearly and closely related to the associated host instrument. Accordingly, the conversion feature is not considered an embedded derivative that requires bifurcation.

The Company accounts for potentially beneficial conversion features under ASC Topic 470-20, Debt with Conversion and Other Options ("ASC 470-20"). At the time of the issuances of the shares of Series A preferred stock, the Company’s common stock into which the Company’s Series A preferred stock was convertible had an estimated fair value less than the effective conversion prices of the shares of Series A preferred stock. Therefore, there was no beneficial conversion element on the issuance dates.

On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the Series A preferred stock was converted into 10,504,199 shares of the Company’s common stock.

Redemption

The holders of the Company’s redeemable convertible preferred stock have no rights to cause the redemption of their shares outside of a Deemed Liquidation Event. A Deemed Liquidation Event would constitute a redemption event that may be outside of the Company’s control.

Any redemption was deemed to be remote at December 31, 2021, and the fair value of Series A preferred stock was deemed to be the price paid by the Series A preferred stockholders.

Due to this redemption option, Series A preferred stock is recorded in mezzanine equity and is subject to subsequent measurement under the guidance provided under ASC 480. In accordance with that guidance, the Company has elected to recognize changes in redemption value immediately.

Warrant Derivative Liabilities

In connection with the Series A preferred stock financing, the Company issued two freestanding detachable stock purchase warrants to an unrelated third party to separately purchase 411,765 and 329,552 shares of common stock (“2019 Warrants”). The 2019 Warrants were exercisable in whole immediately prior to an initial public offering by the Company and, as such, remain issued, outstanding, and exercisable at December 31, 2021. The 2019 Warrants were issued with an initial exercise price of $0.04 and an expiration date of May 13, 2029. The 2019 Warrants qualify as derivative liabilities, which must be accounted for separately from the Series A preferred stock and are measured at fair value on a recurring basis. At December 31, 2021, the 2019 Warrants were valued at $9.2 million, with the change in fair value included in the condensed statements of operations in the period the change occured.

On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the 2019 Warrants were converted into 739,463 shares of the Company’s common stock and are no longer outstanding.

Series B Redeemable Convertible Preferred Stock

In September 2021, the Company authorized the issuance of 35,716,249 shares to be issued in the form of Series B redeemable convertible preferred stock ("Series B preferred stock"). The Company issued 35,716,249 shares of Series B preferred stock at $4.00 per share for total proceeds of $142.9 million. The Company incurred $0.9 million of Series B preferred stock issuance costs which were recorded against the carrying amount of the Series B preferred stock at December 31, 2021. The rights, preferences, and privileges of the Company’s Series B preferred stock prior to the IPO were as follows:

Voting

Up until the IPO, the holders of Series B preferred stock were entitled to a number of votes equal to the number of whole shares of common stock into which the shares of Series B preferred stock were convertible. Except as provided by law or otherwise, the holders of the Series B preferred stock vote together with the holders of common stock as a single class.

Up until the IPO, holders of Series B preferred stock, voting as a separate class, were entitled to elect one member of the Board of Directors. The holders of preferred stock and common stock, voting together as a single class on an as-converted basis, were entitled to elect any additional members of the Board of Directors other than directors elected by the holders of Series A preferred stock and directors elected by holders of the common stock.

Dividends

Dividends at the rate per annum of $0.32 per share accrued on shares of Series B preferred stock. Dividends on the shares of Series B preferred stock were not cumulative and were payable, if and when declared by the Board of Directors. The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company unless the holders of preferred stock then outstanding first or simultaneously receive a dividend on each outstanding share of redeemable convertible preferred stock in an amount at least equal to the sum of (i) the amount of the aggregate dividends accrued but unpaid on such shares of preferred stock and (ii) that dividend per share of preferred stock as would equal the product of (1) the dividend payable on each share of such class or series determined, if applicable, as if all shares of such class or series had been converted into common stock and (2) the number of shares of common stock issuable upon conversion of a share of preferred stock. No dividends were declared or paid since inception of the Company.

Liquidation

In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holders of shares of the Series B preferred stock then outstanding were entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a Deemed Liquidation Event, out of the consideration payable to stockholders in such an event, before any payment shall be made to the holders of Series A preferred stock or common stock by reason of their ownership thereof, an amount per share equal to the Series B preferred stock original issue price, plus any dividends declared but unpaid thereon. If upon any such liquidation, dissolution, or winding up of the Company or a Deemed Liquidation Event, the assets of the Company available for distribution to its stockholders are insufficient to pay the holders of shares of Series B preferred stock the full amount to which they were entitled, the holders of shares of the Series B preferred stock shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts that would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

In the event that the assets of the Company available for distribution exceeded the amount necessary to pay the holders of Series B preferred stock, the holders of shares of Series A preferred stock then outstanding were entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a Deemed Liquidation Event, out of the consideration payable to stockholders in such an event, before any payment shall be made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the Series A preferred stock original issue price, plus any dividends declared but unpaid thereon. If upon any such liquidation, dissolution, or winding up of the Company or a Deemed Liquidation Event, the assets of the Company available for distribution to its stockholders were insufficient to pay the holders of shares of Series A preferred stock the full amount to which they were entitled, the holders of shares of the Series A preferred stock shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts that would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

The remaining available proceeds would have been distributed pro rata among the holders of the shares of the Series B preferred stock, Series A preferred stock and common stock, based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted to common stock pursuant to the applicable terms immediately prior to such liquidation, dissolution, or winding up of the Company.

Conversion

Each share of the Series B preferred stock was convertible, at the option of the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of common stock as determined by dividing the Series B preferred stock original issue price by the Series B preferred stock conversion price in effect at the time of conversion. The Series B preferred stock conversion price shall initially be equal to the Series B original issue price. The applicable conversion price is subject to future adjustments upon the occurrence of certain events. Upon either (i) the closing of a qualified initial public offering of the Company’s common stock resulting in at least $100 million in proceeds net of the underwriting discount and commissions; (ii) the closing of a transaction or series of transactions in which the Company’s outstanding shares of capital stock are exchanged for or converted into securities that are publicly listed on a securities exchange through a merger, acquisition, business combination or similar transaction with a “special purpose acquisition company” where the surviving or parent entity receives aggregate gross proceeds, excluding the cash resources of the Company, of at least $100 million; or (iii) the date and time, or the occurrence of an event, specified by vote or written consent of the requisite holders and the Series B requisite holders, then all outstanding shares of preferred stock shall automatically be converted into shares of common stock at the effective conversion rate.

The Company evaluated the Series B preferred stock and determined that it was considered an equity host under ASC 815. In making this determination, the Company’s analysis followed the whole instrument approach, which compares an individual feature against the entire Series B preferred stock instrument that includes that feature. The Company’s analysis was based on a consideration of the economic characteristics and risks of the Series B preferred stock. More specifically, the Company evaluated all of the stated and implied substantive terms and features, including (i) whether the Series B preferred stock included redemption features, (ii) how and when any redemption features could be exercised, (iii) whether the holders of the Series B preferred stock were entitled to dividends, (iv) the voting rights of the Series B preferred stock, and (v) the existence and nature of any conversion rights. The Company concluded that, as the Series B preferred stock represents an equity host, the conversion feature included in the Series B preferred stock is clearly and closely related to the associated host instrument. Accordingly, the conversion feature is not considered an embedded derivative that requires bifurcation.

The Company accounts for potentially beneficial conversion features under ASC 470-20. At the time of the issuances of the shares of Series B preferred stock, the Company’s common stock into which the Company’s Series B preferred stock was convertible had an estimated fair value less than the effective conversion prices of the shares of Series B preferred stock. Therefore, there was no beneficial conversion element on the issuance dates.

On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the Series B preferred stock was converted into 10,504,779 shares of the Company’s common stock.

Redemption

The holders of the Company’s redeemable convertible preferred stock had no rights to cause the redemption of their shares outside of a Deemed Liquidation Event. A Deemed Liquidation Event would constitute a redemption event that may be outside of the Company’s control.

Any redemption was deemed to be remote at December 31, 2021, and the fair value of Series B preferred stock was deemed to be the price paid by the Series B preferred stockholders.

Due to this redemption option, Series B preferred stock was recorded in mezzanine equity and is subject to subsequent measurement under the guidance provided under ASC 480. In accordance with that guidance, the Company elected to recognize changes in redemption value immediately.

Warrant Derivative Liabilities

In connection with the Series B preferred stock, the Company issued freestanding detachable stock purchase warrants to an unrelated third party to separately purchase 113,610 shares of common stock ("2021 Warrants"). The 2021 Warrants were exercisable in whole immediately prior to an initial public offering by the Company and, as such, remained issued, outstanding, and exercisable at December 31, 2021. The 2021 Warrants were issued with an initial exercise price of $0.01 and an expiration date of May 13, 2029. The 2021 Warrants qualified as derivative liabilities, which must be accounted for separately from the Series B preferred stock and are measured at fair value on a recurring basis. At December 31, 2021, the 2021 Warrants were valued at $1.4 million with the change in fair value from the date of issuance included in the condensed statements of operations in the period the change occured.

On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the 2021 Warrants were converted into 113,325 shares of the Company’s common stock.

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Stockholder's Deficit and Stock-Based Compensation

6 Months Ended

Jun. 30, 2022

Equity [Abstract]

Stockholders’ Deficit and Stock-Based Compensation

6. Stockholders’ Equity (Deficit) and Stock-Based Compensation

Stock Options

On December 30, 2021, the Board of Directors adopted, and the Company’s stockholders approved, the 2022 Equity Incentive Plan (“2022 Plan”). The 2022 Plan provides for the grant of incentive stock options to employees of the Company, and for the grant of non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of stock awards to employees, directors, and consultants, including employees and consultants of affiliates of the Company

(collectively, “stock based awards”). The 2022 Plan is a successor to the 2019 Stock Option Plan. (“2019 Plan”). Initially, the maximum number of shares of common stock that may be issued under the 2022 Plan after it became effective was 6,787,652 shares, which is the sum of (i) 3,905,911 new shares; plus (ii) the number of shares that was available for issuance under the 2019 Plan at the time the 2022 Plan became effective; and (iii) any shares subject to outstanding stock options or other stock awards that were granted under the 2019 Plan that are forfeited, terminated, expired or are otherwise not issued. In addition, the number of shares of common stock reserved for issuance under the 2022 Plan will automatically increase on January 1st of each calendar year, starting on January 1, 2023 and continuing through January 1, 2032, in an amount equal to 5% of the total number of shares of common stock outstanding on the last day of the calendar month before the date of each automatic increase, or a lesser number of shares determined by the Board of Directors. The maximum number of shares of common stock that may be issued on the exercise of incentive stock options under the 2022 Plan is 20,362,956.

As of June 30, 2022 and December 31, 2021, a total of 3,947,670 and 3,368,572 awards, respectively, were available for issuance under the 2022 Plan and 2019 Plan, respectively..

The following is a summary of the Company’s outstanding stock option activity:

	Stock Option Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in Years)		Aggregate Intrinsic Value
Outstanding, January 1, 2022		2,617,072		$	6.19		9.56		—
Granted		68,525			16.51	9.79			—
Exercised		—			—		—		—
Expired/cancelled		—			—		—		—
Outstanding, March 31, 2022		2,685,597		$	6.96		9.37		—
Granted		101,637		$	16.26		6.43		—
Exercised		—			—		—		—
Expired/cancelled		(4,400	)		16.00		—		—
Outstanding, June 30, 2022		2,782,834		$	7.27		9.15	$	32,258,909
Expected to vest, June 30, 2022		2,782,834		$	7.27		9.15	$	32,258,909
Options exercisable, June 30, 2022		628,945		$	6.83		8.88	$	7,553,987

Unrecognized compensation cost related to stock option awards of $13.7 million as of June 30, 2022, is expected to be recognized as expense over a weighted average period of 3.07 years. The total fair value of options vested was $1.6 million and $1.5 million, for the six months period ended June 30, 2022 and 2021, respectively.

Outstanding stock options, if not exercised, expire ten years from the date of grant. The Company issues new shares of common stock upon exercise of stock options. The weighted average grant date fair value per share for the outstanding options at June 30, 2022 and December 31, 2021 was $10.24 and $5.42, respectively.

The Company determined the grant-date fair value of stock options using the Black-Scholes option pricing model. The fair value of each stock option grant was determined using assumptions that are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with a term equivalent to the option. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on companies in the therapeutics and pharmaceutical industries. The expected term of stock options represents the weighted average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determined the expected life assumption using the simplified method, which is an average of the options ordinary vesting period and the contractual term. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts at the time of grant. The Company recognizes forfeitures on an actual basis and, as such, did not estimate forfeitures to calculate stock-based compensation.

The following table presents the weighted average assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted during the following periods:

	Three Months Ended June 30,	Six Months Ended June 30,
	2022	2022
Exercise price	$16.26	$16.36
Stock price on date of grant	$16.26	$16.36
Expected term (years)	6.5	6.5
Expected stock price volatility	75.59%	76.37%
Risk-free rate of interest	2.78%	2.52%
Expected dividend yield	0%	0%

There is a high degree of subjectivity involved when using option-pricing models to estimate stock-based compensation. There are currently no market-based mechanisms or other practical applications to verify the reliability and accuracy of the estimates stemming from these models, nor is there a means to compare and adjust the estimates to actual values. Although the fair value of the employee stock-based awards is determined using an option-pricing model, the value may not be indicative of the fair value that would be observed in a market transaction between a willing buyer and a willing seller. If factors change and the Company employs different assumptions when valuing its options, the compensation expense that the Company records in the future may differ significantly from what it has historically reported.

Restricted Stock Units

In 2022, certain employees were awarded restricted stock units with time-based vesting. During the three and six months ended June 30, 2022, the Company granted to certain employees 30,148 time-based vesting restricted stock units, with a weighted average grant date fair value of $16.00. As of June 30, 2022, none of the restricted stock units had vested. As of June 30, 2022, the Company had unrecognized stock-based compensation expense related to restricted stock units of approximately $0.4 million with a weighted average vesting period of approximately 1.50 years. The expense is recognized over the vesting period of the award.

The Company recognized the following compensation cost related to employee stock-based compensation activity:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Research and development	$	257,705	$	40,121	$	485,295	$	531,930
General and administrative		983,452		253,728		1,980,070		1,151,874
Total	$	1,241,157	$	293,849	$	2,465,365	$	1,683,804

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Net Loss per Share Attributable to Common Stockholders

6 Months Ended

Jun. 30, 2022

Earnings Per Share [Abstract]

Net and Comprehensive Loss Per Share (Restated)

7. Net Loss per Share Attributable to Common Stockholders

Net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same.

The following weighted average common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect for the following periods:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Redeemed convertible preferred stock (if converted)		—		10,504,199		—		10,504,199
2019 Warrants		—		739,463		—		739,463
Outstanding equity awards exercisable		1,052,120		34,960		1,077,534		34,198

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Related-Party Transactions

6 Months Ended

Jun. 30, 2022

Related Party Transactions [Abstract]

Related-Party Transactions

8. Related-Party Transactions

CinRx Pharma LLC and Subsidiaries (“CinRx”)

Certain former executives and employees of the Company, including the Company’s former chief executive officer and a former member of the Company’s board of directors, are members of CinRx’s board of managers and/or have equity investments in CinRx. The Company received business management services from CinRx from time to time as needed, under a management services agreement, which was terminated on February 2, 2022. There were no business management service fees from CinRx during the three and six months ended June 30, 2022. During the three and six months ended June 30, 2021, the Company recorded business management fees totaling $0.5 million and $0.8 million, respectively. For the three months ended June 30, 2021, $0.3 million are included in research and development expenses, while $0.2 million are in general and administrative expenses on the condensed statement of operations. For the six months ending June 30, 2021, $0.5 million of the fees are included in research and development expenses, while $0.3 million are in general and administrative expenses on the condensed statement of operations.

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Commitments and Contingencies

6 Months Ended

Jun. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

9. Commitments and Contingencies

Lease

On February 24, 2022, the Company entered into a license agreement, commencing April 1, 2022, for 5,400 square feet of office space in Waltham, Massachusetts, which is the Company's new headquarters. The annual rent is $0.3 million. As this license agreement has a term of less than 12 months, the Company has not recorded it on the condensed balance sheet, as allowed under ASC Topic 842, Leases ("ASC 842"). The Company also has an agreement to lease 221 square feet of office space at 7875 Montgomery Rd. Suite 42, Cincinnati, OH 45236 from COHatch Cincinnati for $2,850 per month. As this lease has a term of less than 12 months, the Company has not recorded it on the condensed balance sheet, as allowed under ASC 842. The Company's total rent expense for the three and six months ended June 30, 2022, were $0.1 million and $0.2 million, respectively, recorded in general and administrative expense on our condensed statements of operations. No rent expense was recognized for the three and six months ended June 30, 2021.

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Employee Benefit Plan

6 Months Ended

Jun. 30, 2022

Share-based Payment Arrangement, Disclosure [Abstract]

Employee Benefit Plan

10. Employee Benefit Plan

The Company maintains a defined contribution 401(k) plan available to full time employees. Employee contributions are voluntary and are determined on an individual basis, limited by the maximum amounts allowable under federal tax regulations. The Company provides a safe harbor contribution of 4% of the employee's salary. The Company’s safe harbor contributions recorded for the three and six months ending June 30, 2022, totaled approximately $0.1 million and $0.1 million, respectively, are included in research and development expense and general and administrative expense on the condensed statements of operations. The 401(k) plan was not in place during the three and six months ended June 30, 2021.

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Summary of Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2022

Accounting Policies [Abstract]

Basis of Presentation

Basis of Presentation

The unaudited condensed financial statements have been prepared in accordance with U.S. Securities and Exchange Commission (“SEC”) regulations and include all of the information and disclosures required by U.S. generally accepted accounting principles (“U.S. GAAP” or “GAAP”) for interim financial reporting, and, in the opinion of management include all adjustments necessary for a fair presentation of the condensed financial statements for each period presented. All adjustments are normal and recurring in nature. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). These unaudited condensed financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2021 in the Company’s Annual Report on Form 10-K filed with the SEC on March 22, 2022. The results of operations for the interim periods are not necessarily indicative of results of operations for a full year. The Company’s condensed financial statements are stated in U.S. Dollars.

Segment Information

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment. All the assets and operations of the Company’s sole operating segment are located in the United States.

Use of Estimates

Use of Estimates

The preparation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the

condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls and in developing the estimates and assumptions that are used in the preparation of these condensed financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates have been or are used in the following areas, among others: prepaid research and development contracts, fair value of the Company's common stock prior to the IPO, fair value of warrant derivative liabilities, stock compensation expense and income taxes.

Prior to its IPO, the Company utilized estimates and assumptions in determining the fair value of its common stock. The Company has granted stock options at exercise prices that represented the fair value of its common stock on grant date. The Company utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation, to estimate the fair value of its common stock prior to its IPO. Each valuation methodology includes estimates and assumptions that require the Company's judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of redeemable convertible preferred stock, the superior rights and preferences of the redeemable convertible preferred stock senior to the Company's common stock at the time, and a probability analysis of various liquidity events at that time, such as a public offering or sale of the Company, under differing scenarios. Changes to the key assumptions used in the valuations could have resulted in different fair values of common stock at each valuation date.

The Company's results and business operations can also be affected or disrupted by economic, political, legislative, health concerns, such as the COVID-19 pandemic, regulatory, legal actions and geopolitical events, such as the ongoing military conflict between Ukraine and Russia and the related sanctions against Russia. Economic conditions, such as recessionary trends, inflation, interest, changes in regulatory laws and monetary exchange rates, and government fiscal policies, can also have a significant effect on operations. In addition, the conflict between Russia and Ukraine and related sanctions has had significant ramifications on global financial markets, including volatility in the U.S. and global financial markets, which has led to disruptions to trade, commerce, pricing stability, credit availability, supply chain continuity and reduced access to liquidity globally, and has caused and may continue to cause volatility in the price of our common stock, which may adversely impact our ability to raise capital on favorable terms or at all. The full economic and social impact of the sanctions imposed on Russia and possible future punitive measures that may be implemented, as well as the counter measures imposed by Russia, in addition to the ongoing military conflict between Ukraine and Russia remains uncertain; however, both the conflict and related sanctions have resulted and could continue to result in disruptions to trade, commerce, pricing stability, credit availability, supply chain continuity and reduced access to liquidity on acceptable terms, in both Europe and globally, and has introduced significant uncertainty into global markets. As a result, our business and results of operations may be adversely affected by the ongoing conflict between Ukraine and Russia and related sanctions, particularly to the extent it escalates to involve additional countries, further economic sanctions or wider military conflict. While the Company maintains reserves for anticipated liabilities, the Company could be affected by civil, criminal, regulatory, or administrative actions, claims, or proceedings. The extent to which the Company’s business can be impacted by future events is highly uncertain and cannot be predicted at this time.

Concentration of Credit Risk and Other Risks and Uncertainties

Concentration of Credit Risk and Other Risks and Uncertainties

The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements. Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash and cash equivalents, which consist of money market funds that invest primarily in short­ term U.S. government securities and short-term marketable securities that are primarily invested in fixed income securities.

The Company has not yet generated any revenue from the sale of its products and is subject to all of the risks and uncertainties that are typically faced by biopharmaceutical companies that devote substantially all of their efforts to research and development and clinical trials and do not yet have commercial products. The Company expects to continue incurring losses for the foreseeable future.

Cash and Cash Equivalents

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include cash held in banks and amounts held primarily in interest-bearing money market accounts. Cash equivalents are carried at cost, which approximates their fair market value.

Marketable Securities

Marketable Securities

The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each condensed balance sheet date. The Company classified all of its marketable securities at December 31, 2021 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value with the unrealized gains and losses included in other comprehensive loss as a component of stockholders’ equity (deficit) until realized. Any premium or discount arising at purchase is amortized or accreted to interest income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are

included in other (income) expense, net. There were no material realized gains or losses on marketable securities recognized for the three and six months ended June 30, 2022 or 2021.

Initial Public Offering Costs

Initial Public Offering Costs

Costs directly attributable to the Company’s IPO which were incurred in 2021 were deferred and capitalized as prepaid expenses and other current assets at December 31, 2021. These costs primarily represented legal, underwriting and accounting costs related to the Company’s efforts to raise capital through a public sale of its common stock. Any additional costs incurred during the six months ended June 30, 2022 were deferred until the completion of the IPO, which occurred on January 11, 2022, at which time they were reclassified to additional paid in capital as a reduction of the IPO gross proceeds. At December 31, 2021, the Company had capitalized $2.6 million of deferred IPO costs, as prepaid expenses and other current assets. A total of $4.5 million of IPO issuance costs were incurred through January 11, 2022, which were recorded as a reduction of the IPO gross proceeds and included the $2.6 million previously capitalized in 2021.

Redeemable Convertible Preferred Stock

Redeemable Convertible Preferred Stock

In accordance with ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480”), preferred stock issued with redemption provisions that are outside of the control of the issuer or that contain certain redemption features in a Deemed Liquidation Event (as defined in our Amended and Restated Certificate of Incorporation) is required to be presented outside of stockholders' equity (deficit) on the face of the condensed balance sheet and certain disclosures are required to be included in the notes to the condensed financial statements. If required, changes in fair value are recorded as additional paid in capital and/or accumulated deficit in the condensed balance sheets. Changes in fair value that would reduce the fair value of the redeemable convertible preferred stock below the original issue price are limited so that the value of the shares are not recorded below the original issue price.

Fair Value Measurements

Fair Value Measurements

Financial assets and liabilities are recorded at fair value. The carrying amount of certain financial instruments, including accounts payable and other current liabilities approximate fair value due to their relatively short maturities. Assets and liabilities recorded at fair value on a recurring basis in the condensed balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:

Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;

Level 2—Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and

Level 3—Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data.

Where quoted prices are available in an active market, assets or liabilities are classified as Level 1.

To the extent that a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument's level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. There were no transfers within the fair value hierarchy in 2022 and 2021.

Research and Development

Research and Development

The Company charges all research and development costs, both internal and external, to expense when incurred. Costs are considered incurred based on an evaluation of the progress to completion of specific tasks under each contract using information and data provided to the Company by its clinical sites and vendors. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company. The Company's research and development expenses consist primarily of clinical trial expenses, consulting costs and stock-based compensation, and costs associated with required regulatory filings, licenses, and fees.

Stock-Based Compensation

Stock-Based Compensation

The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718, Compensation – Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, including grants of employee stock options and restricted stock units, to be recognized in the statements of operations based on their fair values. The Company’s stock-based awards are subject only to service-based vesting conditions. The Company estimates the fair value of its stock-based awards in the form of employee stock options, using the Black-Scholes option pricing model, which requires the input of assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends.

Prior to its IPO, the Company had based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The computation of expected volatility is based on the historical volatility of a representative group of companies

with similar characteristics to the Company, including stage of product development and life science industry focus. The Company believes the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of the Company.

The Company uses the simplified method as prescribed by the SEC Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term for options granted to employees and utilizes the contractual term for options granted to non-employees. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of the stock options.

Compensation expense related to awards to employees is calculated on a straight-line basis by recognizing the grant date fair value over the associated service period of the award, which is generally the vesting term.

Derivative Instruments, Including Warrant Derivative Liabilities

Derivative Instruments, Including Warrant Derivative Liabilities

The Company accounts for derivatives, specifically freestanding detachable stock purchase warrants, in accordance with ASC Topic 815, Derivatives and Hedging ("ASC 815"). This guidance establishes accounting and reporting principles for derivative instruments, including certain derivative instruments embedded in other contracts.

Net Loss Per Share

Net Loss Per Share

The Company's basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share attributable to common stockholders is computed by giving effect to all potential common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, redeemable convertible preferred stock prior to the Company's IPO and stock options to purchase common stock are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share attributable to common stockholders as their effect is anti-dilutive.

Income Taxes

Income Taxes

Income taxes are recorded in accordance with ASC Topic 740, Income Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the condensed financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the condensed financial statement and tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates anticipated to be in effect for the year in which the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all the deferred tax assets will not be realized.

The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that some or all the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. As of June 30, 2022, and December 31, 2021, the Company does not have any significant uncertain tax positions. If the Company were to incur interest and penalties on uncertain tax positions, it would classify them as income tax expense.

The Company files U.S. federal and state income tax returns.

The Company did not record a current or deferred income tax expense or benefit for the three and six months ended June 30, 2022 and 2021, due to the Company’s net and comprehensive losses and increases in its deferred tax asset valuation allowance.

Comprehensive Loss

Comprehensive Loss

Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. For the three and six months ended June 30, 2022, the Company’s only element of other comprehensive loss was unrealized losses on available-for-sale securities. Comprehensive loss for the three and six months ended June 30, 2021, equaled net loss for those periods.

Litigation And Other Contingencies

Litigation and Other Contingencies

The Company may be subject to legal proceedings and claims arising from the ordinary course of its business, including contract and employment claims. U.S. GAAP requires that a liability for contingencies be recorded when it is probable that a liability has occurred, and the amount of the liability can be reasonably estimated. In the opinion of management, the aggregate liability, if any, with respect to such ordinary course of business actions will not have a material adverse effect on the financial position or results of operations of the Company.

Reverse Stock Split

Reverse Stock Split

On December 30, 2021, the Company’s Board of Directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 3.4-for-1 reverse stock split of the Company’s common stock, which was effected on December 30, 2021. Stockholders entitled to fractional shares as a result of the reverse stock split received a cash payment in lieu of receiving fractional shares. The par value of the common stock was not adjusted as a result of the reverse stock split. Shares of common stock underlying outstanding stock options and other equity instruments were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the appropriate securities agreements. Shares of common stock reserved for issuance upon the conversion of our convertible preferred stock were proportionately reduced and the respective conversion prices were proportionately increased. All common share and per share data have been retrospectively revised including the three and six months ended June 30, 2021, to reflect the reverse stock split.

Recent Accounting Pronouncements

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

XML

Fair Value of Measurements (Tables)

6 Months Ended

Jun. 30, 2022

Fair Value Disclosures [Abstract]

Schedule of Financial Instruments Measured at Fair Value on Recurring Basis Based on Fair Value Hierarchy

The following table represents the financial instruments measured at fair value on a recurring basis based on the fair value hierarchy at:

	June 30, 2022
	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	127,619,608	$	—	$	—	$	127,619,608
Marketable securities:
US Treasury bills		74,612,727		—		—		74,612,727
Certificate of deposit		42,587,053		—		—		42,587,053
US Government agency securities		—		49,492,515		—		49,492,515
Total assets at fair value	$	244,819,388	$	49,492,515	$	—	$	294,311,903
	December 31, 2021
	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	136,605,613	$	—	$	—	$	136,605,613
Total assets at fair value	$	136,605,613	$	—	$	—	$	136,605,613
Liabilities:
Warrant derivative liabilities	$	—	$	—	$	10,636,921	$	10,636,921
Total liabilities at fair value	$	—	$	—	$	10,636,921	$	10,636,921

Schedule of Changes in Fair Value of Warrant Derivative Liabilities

The following table sets forth a summary of changes in the fair value of the warrant derivative liabilities, representing a recurring measurement that is classified within Level 3 of the fair value hierarchy:

January 1, 2022	$	10,636,921
Change in fair value of warrant derivative liabilities		3,044,006
Automatic conversion of Roche warrants into common stock upon initial public offering		(13,680,927	)
June 30, 2022	$	-

Schedule of Fair Value of Warrant Derivative Liabilities

The Company estimated the fair value of the warrant derivative liabilities using a Black-Scholes option pricing model. The valuation model used the following assumptions at December 31, 2021:

	December 31,
	2021
Fair value of common stock	$	12.44
Volatility		64.00	%
Expected term (in years)		0.52
Risk-free interest rate		0.21	%
Dividend yield		—

XML

Stockholder's Deficit and Stock-Based Compensation (Tables)

6 Months Ended

Jun. 30, 2022

Equity [Abstract]

Summary of Outstanding Stock Option Activity

The following is a summary of the Company’s outstanding stock option activity:

	Stock Option Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in Years)		Aggregate Intrinsic Value
Outstanding, January 1, 2022		2,617,072		$	6.19		9.56		—
Granted		68,525			16.51	9.79			—
Exercised		—			—		—		—
Expired/cancelled		—			—		—		—
Outstanding, March 31, 2022		2,685,597		$	6.96		9.37		—
Granted		101,637		$	16.26		6.43		—
Exercised		—			—		—		—
Expired/cancelled		(4,400	)		16.00		—		—
Outstanding, June 30, 2022		2,782,834		$	7.27		9.15	$	32,258,909
Expected to vest, June 30, 2022		2,782,834		$	7.27		9.15	$	32,258,909
Options exercisable, June 30, 2022		628,945		$	6.83		8.88	$	7,553,987

Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions

The following table presents the weighted average assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted during the following periods:

	Three Months Ended June 30,	Six Months Ended June 30,
	2022	2022
Exercise price	$16.26	$16.36
Stock price on date of grant	$16.26	$16.36
Expected term (years)	6.5	6.5
Expected stock price volatility	75.59%	76.37%
Risk-free rate of interest	2.78%	2.52%
Expected dividend yield	0%	0%

Schedule Of Compensation Cost Related to Employee Stock-Based Compensation Activity

The Company recognized the following compensation cost related to employee stock-based compensation activity:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Research and development	$	257,705	$	40,121	$	485,295	$	531,930
General and administrative		983,452		253,728		1,980,070		1,151,874
Total	$	1,241,157	$	293,849	$	2,465,365	$	1,683,804

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Net Loss per Share Attributable to Common Stockholders (Tables)

6 Months Ended

Jun. 30, 2022

Earnings Per Share [Abstract]

Schedule of Basic and Diluted Net and Comprehensive Loss Per Share

The following weighted average common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect for the following periods:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Redeemed convertible preferred stock (if converted)		—		10,504,199		—		10,504,199
2019 Warrants		—		739,463		—		739,463
Outstanding equity awards exercisable		1,052,120		34,960		1,077,534		34,198

XML

Nature of Business (Additional Information) (Details) $ / shares in Units, $ in Millions	Jan. 11, 2022 USD ($) $ / shares shares	Jun. 30, 2022 USD ($) $ / shares	Dec. 31, 2021 $ / shares
Subsidiary, Sale of Stock [Line Items]
Common stock, par value per share | $ / shares		$ 0.00001	$ 0.00001
Convertible preferred stock converted to common stock	3.4
Series B [Member]
Subsidiary, Sale of Stock [Line Items]
Preferred stock converted into common stock | shares	21,008,970
IPO [Member]
Subsidiary, Sale of Stock [Line Items]
Common stock, shares issued | shares	13,290,813
Common stock, par value per share | $ / shares	$ 16.00
Offering expenses | $		$ 2.6
IPO [Member] | Series A [Member]
Subsidiary, Sale of Stock [Line Items]
Preferred stock converted into common stock | shares	10,504,199
Over-allotment [Member]
Subsidiary, Sale of Stock [Line Items]
Proceeds from IPO | $	$ 193.6
Underwriting discounts and commissions | $	14.9
Offering expenses | $	$ 4.5
Roche Warrants [Member]
Subsidiary, Sale of Stock [Line Items]
Preferred stock converted into common stock | shares	852,788

XML

Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Millions	6 Months Ended
	Jun. 30, 2022	Jan. 11, 2022	Dec. 31, 2021
Accounting Policies [Line Items]
Stockholders' Equity Note, Stock Split, Conversion Ratio	On December 30, 2021, the Company’s Board of Directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 3.4-for-1 reverse stock split of the Company’s common stock, which was effected on December 30, 2021.
IPO
Accounting Policies [Line Items]
Deferred IPO costs	$ 2.6
Reduction in IPO gross proceeds		$ 4.5
IPO | Prepaid Expenses and Other Current Assets
Accounting Policies [Line Items]
Deferred IPO costs			$ 2.6

XML

Fair Value of Financial Instruments - Schedule of Financial Instruments Measured at Fair Value on Recurring Basis Based on Fair Value Hier (Details) - Fair Value Measurements Recurring [Member] - USD ($)	Jun. 30, 2022	Dec. 31, 2021
Assets:
Cash and cash equivalents	$ 127,619,608	$ 136,605,613
Marketable Securities:
Total assets at fair value	294,311,903	136,605,613
Liabilities:
Warrant derivative liabilities		10,636,921
Total liabilities at fair value		10,636,921
Level 1 [Member]
Assets:
Cash and cash equivalents	127,619,608	136,605,613
Marketable Securities:
Total assets at fair value	244,819,388	136,605,613
Liabilities:
Warrant derivative liabilities		0
Total liabilities at fair value		0
Level 2 [Member]
Assets:
Cash and cash equivalents	0	0
Marketable Securities:
Total assets at fair value	49,492,515	0
Liabilities:
Warrant derivative liabilities		0
Total liabilities at fair value		0
Level 3 [Member]
Assets:
Cash and cash equivalents	0	0
Marketable Securities:
Total assets at fair value	0	0
Liabilities:
Warrant derivative liabilities		10,636,921
Total liabilities at fair value		$ 10,636,921
US Treasury Bills [Member]
Marketable Securities:
Debt Securities, Available-for-Sale	74,612,727
US Treasury Bills [Member] | Level 1 [Member]
Marketable Securities:
Debt Securities, Available-for-Sale	74,612,727
US Treasury Bills [Member] | Level 2 [Member]
Marketable Securities:
Debt Securities, Available-for-Sale
US Treasury Bills [Member] | Level 3 [Member]
Marketable Securities:
Debt Securities, Available-for-Sale
Certificates of Deposit [Member]
Marketable Securities:
Debt Securities, Available-for-Sale	42,587,053
Certificates of Deposit [Member] | Level 1 [Member]
Marketable Securities:
Debt Securities, Available-for-Sale	42,587,053
Certificates of Deposit [Member] | Level 2 [Member]
Marketable Securities:
Debt Securities, Available-for-Sale
Certificates of Deposit [Member] | Level 3 [Member]
Marketable Securities:
Debt Securities, Available-for-Sale
Debt Securities in government sponsored entities [Member]
Marketable Securities:
Debt Securities, Available-for-Sale	49,492,515
Debt Securities in government sponsored entities [Member] | Level 2 [Member]
Marketable Securities:
Debt Securities, Available-for-Sale	$ 49,492,515

XML

Fair Value of Financial Instruments - Change in Fair Value of Warrant Liabilities (Details) - Level 3	6 Months Ended
	Jun. 30, 2022 USD ($)
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Balance	$ 10,636,921
Change in fair value of warrant derivative liabilities	3,044,006
Automatic conversion of Roche warrants into common stock upon initial public offering	(13,680,927)
Balance	$ 0

XML

Fair Value of Financial Instruments - Schedule of Fair Value of Warrant Derivative Liabilities (Details)	Dec. 31, 2021 USD ($)
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items]
Warrant outstanding	$ 12.44
Volatility
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items]
Warrants and rights outstanding, measurement input	64.00
Expected term (in years)
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items]
Warrants and rights outstanding, measurement input	6 months 7 days
Risk-free interest rate
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items]
Warrants and rights outstanding, measurement input	0.21
Dividend yield
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items]
Warrants and rights outstanding, measurement input

XML

Fair Value of Financial Instruments (Additional Information) (Details) $ in Millions	Jun. 30, 2022 USD ($)
Fair Value Disclosures [Abstract]
Amortized cost of marketable securities	$ 182.4

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License Agreement - Additional Information (Details) - Roche License Agreement [Member] - USD ($) $ in Millions	1 Months Ended	3 Months Ended		6 Months Ended
	May 31, 2019	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Finite Lived Intangible Assets [Line Items]
Nonrefundable payment received	$ 2.0
Non-cash royalty expense		$ 0.0	$ 1.2	$ 3.0	$ 2.4

XML

Redeemable Convertible Preferred Stock - Additional Information (Details)	3 Months Ended		6 Months Ended		12 Months Ended
	Jun. 30, 2022 USD ($) $ / shares shares	Jun. 30, 2021 USD ($) shares	Jun. 30, 2022 USD ($) Warrants $ / shares shares	Jun. 30, 2021 USD ($) shares	Dec. 31, 2021 USD ($) $ / shares shares	Dec. 31, 2019 USD ($) $ / shares shares	Jan. 11, 2022 shares	Sep. 30, 2021 shares	Mar. 31, 2021 shares	Dec. 31, 2020 shares	May 31, 2019 shares
Temporary Equity [Line Items]
Payments of stock issuance costs			$ 2,219,207
Change in fair value of warrant derivative liabilities		$ 1,209,829	$ 3,044,006	$ 2,419,657
2019 Warrant [Member]
Temporary Equity [Line Items]
Warrants converted into common stock | shares							739,463
2021 Warrant [Member]
Temporary Equity [Line Items]
Change in fair value of warrant derivative liabilities					$ 1,400,000
Warrants converted into common stock | shares							113,325
IPO
Temporary Equity [Line Items]
Sale of stock, price per share | $ / shares	$ 14.28		$ 14.28
Series A | IPO
Temporary Equity [Line Items]
Proceeds of underwriting discount and commissions net	$ 50,000,000		$ 50,000,000
Series B | IPO
Temporary Equity [Line Items]
Proceeds of underwriting discount and commissions net	$ 100,000,000		$ 100,000,000
Series A Redeemable Convertible Preferred Stock [Member]
Temporary Equity [Line Items]
Temporary equity, shares authorized | shares	0		0		35,714,282						35,714,282
Temporary equity, shares outstanding | shares	0	35,714,282	0	35,714,282	35,714,282				35,714,282	35,714,282
Temporary Equity, Redemption Price Per Share | $ / shares						$ 1.40
Payments of stock issuance costs					$ 2,100,000
Dividends payable	$ 0		$ 0
Proceeds from issuance of convertible preferred stock						$ 50,000,000
Beneficial conversion feature			$ 0
Series A Redeemable Convertible Preferred Stock [Member] | Preferred Stock [Member]
Temporary Equity [Line Items]
Temporary equity, shares issued | shares						35,714,282
Series A Redeemable Convertible Preferred Stock [Member] | 2019 Warrant [Member]
Temporary Equity [Line Items]
Warrant purchased | shares	329,552		329,552
Valuation of Warrants					$ 9,200,000
Class of warrant, exercise price of warrants | $ / shares	$ 0.04		$ 0.04
Class of Warrant, expiration date			May 13, 2029
Series A Redeemable Convertible Preferred Stock [Member] | Warrant [Member]
Temporary Equity [Line Items]
Number of warrant issued | Warrants			2
Warrant purchased | shares	411,765		411,765
Series B Redeemable Convertible Preferred Stock [Member]
Temporary Equity [Line Items]
Temporary equity, shares authorized | shares	0		0		35,716,249			35,716,249
Temporary equity, shares issued | shares					35,716,249
Temporary equity, shares outstanding | shares	0		0		35,716,249
Temporary Equity, Redemption Price Per Share | $ / shares					$ 4.00
Payments of stock issuance costs					$ 900,000
Dividends payable	$ 0		$ 0
Proceeds from issuance of convertible preferred stock					$ 142,900,000
Dividends payable, amount per share | $ / shares	$ 0.32		$ 0.32
Beneficial conversion feature			$ 0
Preferred stock converted into common stock | shares							10,504,779
Series B Redeemable Convertible Preferred Stock [Member] | 2021 Warrant [Member]
Temporary Equity [Line Items]
Warrant purchased | shares	113,610		113,610
Class of warrant, exercise price of warrants | $ / shares	$ 0.01		$ 0.01
Class of Warrant, expiration date			May 13, 2029
Series A Preferred Stock [Member] | IPO
Temporary Equity [Line Items]
Preferred stock converted into common stock | shares							10,504,199

XML

Stockholder's Deficit and Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions		3 Months Ended		6 Months Ended		12 Months Ended
	Dec. 30, 2021	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2022	Jun. 30, 2021	Dec. 31, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock Option Shares outstanding, Granted		101,637	68,525
Stock Option Shares outstanding, Options exercisable		628,945		628,945
Restricted Stock [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock Option Shares outstanding, Granted				30,148
Unrecognized compensation costs		$ 0.4		$ 0.4
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition				1 year 6 months
Weighted average grant date fair value				$ 16.00
2019 Stock Option Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Unrecognized compensation costs		$ 13.7		$ 13.7
Share-based compensation options, vested in period, fair value				$ 1.6	$ 1.5
Option expiration from the date of grant				10 years
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition				3 years 25 days
Weighted average grant date fair value				$ 10.24		$ 5.42
2022 Stock Option Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Share-based compensation arrangement by share-based payment award, number of shares available for grant		3,947,670		3,947,670		3,368,572
Share-based Compensation Arrangement by Share-based Payment Award, Description	any shares subject to outstanding stock options or other stock awards that were granted under the 2019 Plan that are forfeited, terminated, expired or are otherwise not issued. In addition, the number of shares of common stock reserved for issuance under the 2022 Plan will automatically increase on January 1st of each calendar year, starting on January 1, 2023 and continuing through January 1, 2032, in an amount equal to 5% of the total number of shares of common stock outstanding on the last day of the calendar month before the date of each automatic increase, or a lesser number of shares determined by the Board of Directors.
Common stock, shares issued	3,905,911
2022 Stock Option Plan | Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Common stock, shares issued	6,787,652	20,362,956		20,362,956

XML

Stockholder's Deficit and Stock-Based Compensation - Summary of Outstanding Stock Option Activity (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2022
Equity [Abstract]
Stock Option Shares outstanding, Beginning Balance	2,685,597	2,617,072	2,617,072
Stock Option Shares outstanding, Granted	101,637	68,525
Stock Option Shares outstanding, Expired/cancelled	(4,400)
Stock Option Shares outstanding, Ending Balance	2,782,834	2,685,597	2,782,834
Stock Option Shares outstanding, Expected to vest	2,782,834		2,782,834
Stock Option Shares outstanding, Options exercisable	628,945		628,945
Weighted average exercise price, Beginning Balance	$ 6.96	$ 6.19	$ 6.19
Weighted average exercise price, granted	16.26	16.51
Weighted average exercise price, Expired/cancelled	16.00
Weighted average exercise price, Ending Balance	7.27	$ 6.96	7.27
Weighted average exercise price, expected to vest	7.27		7.27
Weighted average exercise price, exercisable	$ 6.83		$ 6.83
Weighted Average Remaining Contractual Term (in Years)	9 years 4 months 13 days	9 years 6 months 21 days
Weighted Average Remaining Contractual Term, Granted (in Years)	6 years 5 months 4 days	9 years 9 months 14 days
Weighted Average Remaining Contractual Term	9 years 1 month 24 days
Weighted Average Remaining Contractual Term, Expected to vest (in Years)	9 years 1 month 24 days
Weighted Average Remaining Contractual Term, Options exercisable (in Years)	8 years 10 months 17 days
Aggregate Intrinsic Value Outstanding, Ending Balance	$ 32,258,909		$ 32,258,909
Expected to vest, June 30, 2022	32,258,909		32,258,909
Options exercisable, June 30, 2022	$ 7,553,987		$ 7,553,987

XML

Stockholder's Deficit and Stock-Based Compensation - Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions (Details) - $ / shares	3 Months Ended	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2022
Equity [Abstract]
Exercise price	$ 16.26	$ 16.36
Stock price on date of grant	$ 16.26	$ 16.36
Expected term (years)	6 years 6 months	6 years 6 months
Expected stock price volatility%	75.59%	76.37%
Risk-free rate of interest%	2.78%	2.52%
Expected dividend yield%	0.00%	0.00%

XML

Stockholders' Deficit and Stock-Based Compensation - Schedule of compensation cost related to employee stock-based compensation activity (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Compensation cost	$ 1,241,157	$ 293,849	$ 2,465,365	$ 1,683,804
Research and development
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Compensation cost	257,705	40,121	485,295	531,930
General and administrative
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Compensation cost	$ 983,452	$ 253,728	$ 1,980,070	$ 1,151,874

XML

Net Loss per Share Attributable to Common Stockholders - Schedule of Weighted Average Common Stock Equivalents (Details) - shares	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Redeemable Convertible Preferred Stock
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Redeemed convertible preferred stock (if converted)	0	10,504,199	0	10,504,199
2019 Warrants
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Redeemed convertible preferred stock (if converted)	0	739,463	0	739,463
Outstanding options exercisable
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Redeemed convertible preferred stock (if converted)	1,052,120	34,960	1,077,534	34,198

XML

Related-Party Transactions - Additional Information (Details) - CinRx [Member] - USD ($) $ in Millions	3 Months Ended	6 Months Ended
	Jun. 30, 2021	Jun. 30, 2021
Related Party Transaction [Line Items]
Management fee expense	$ 0.5	$ 0.8
Research and Development Expense [Member]
Related Party Transaction [Line Items]
Related part transaction research and development expenses	0.3	0.5
General and Administrative Expense [Member]
Related Party Transaction [Line Items]
Related part transaction research and development expenses	$ 0.2	$ 0.3

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Commitments and Contingencies (Additional Information) (Details)	3 Months Ended		6 Months Ended
	Jun. 30, 2022 USD ($) ft²	Jun. 30, 2021 USD ($)	Jun. 30, 2022 USD ($) ft²	Jun. 30, 2021 USD ($)	Feb. 24, 2022 ft²
Floor Area Size | ft²					5,400
Lease commencing date					Apr. 01, 2022
Payments for rent			$ 300,000
Rent expense	$ 100,000	$ 0	200,000	$ 0
COHatch Cincinnati [Member]
Lease Payment			$ 2,850
Floor Area Size | ft²	221		221

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Employee Benefit Plan (Additional Information) (Details) - USD ($) $ in Millions	3 Months Ended	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2022
Retirement Benefits [Abstract]
Defined contribution plan, employer matching contribution, percent		4.00%
Defined contribution plan, administrative expenses	$ 0.1	$ 0.1