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l

 

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 September 30, 2023

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: 001-40800

 

TYRA BIOSCIENCES, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

83-1476348

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

2656 State Street

Carlsbad, California

92008

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (619) 728-4760

 

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, $0.0001 par value per share

 

TYRA

 

The Nasdaq Global Select Market

 

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, 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 November 6, 2023, the registrant had 43,058,747 shares of common stock, $0.0001 par value per share, outstanding.

 

 


Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

Item 1.

Condensed Financial Statements

2

Condensed Balance Sheets

2

Condensed Statements of Operations and Comprehensive Loss

3

Condensed Statements of Stockholders' Equity

4

Condensed Statements of Cash Flows

6

Notes to the Condensed Financial Statements

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

15

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

23

Item 4.

Controls and Procedures

23

PART II.

OTHER INFORMATION

Item 1.

Legal Proceedings

24

Item 1A.

Risk Factors

24

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

24

Item 3.

Defaults Upon Senior Securities

24

Item 4.

Mine Safety Disclosures

24

Item 5.

Other Information

24

Item 6.

Exhibits

25

Signatures

26

 

 

i


 

PART I—FINANCIAL INFORMATION

Item 1. Condensed Financial Statements

Tyra Biosciences, Inc.
Condensed Ba
lance Sheets

(in thousands, except share and par value data)

 

 

 

September 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

215,652

 

 

$

251,213

 

Prepaid and other current assets

 

 

8,978

 

 

 

6,075

 

Total current assets

 

 

224,630

 

 

 

257,288

 

Restricted cash

 

 

1,000

 

 

 

1,000

 

Property and equipment, net

 

 

1,147

 

 

 

1,077

 

Right-of-use assets

 

 

6,236

 

 

 

2,466

 

Other long-term assets

 

 

5,345

 

 

 

4,350

 

Total assets

 

$

238,358

 

 

$

266,181

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,308

 

 

$

1,145

 

Lease liabilities, current

 

 

148

 

 

 

140

 

Accrued and other current liabilities (including related party amounts
   of $
0 and $59, respectively)

 

 

7,691

 

 

 

4,416

 

Total current liabilities

 

 

10,147

 

 

 

5,701

 

Lease liabilities, noncurrent

 

 

5,964

 

 

 

2,482

 

Other long-term liabilities

 

 

77

 

 

 

169

 

Total liabilities

 

 

16,188

 

 

 

8,352

 

Commitments and contingencies (Note 10)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 50,000,000 shares
   authorized at September 30, 2023 and December 31, 2022;
   
no shares issued and outstanding at September 30, 2023 and
   December 31, 2022.

 

 

 

 

 

 

Common stock, $0.0001 par value; 500,000,000 shares authorized
   at September 30, 2023 and December 31, 2022;
43,055,393 and 42,634,459
   shares issued at September 30, 2023 and December 31, 2022, respectively,
   and
42,928,884 and 42,353,550 shares outstanding at September 30, 2023
   and December 31, 2022, respectively.

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

364,166

 

 

 

353,521

 

Accumulated deficit

 

 

(142,000

)

 

 

(95,696

)

Total stockholders’ equity

 

 

222,170

 

 

 

257,829

 

Total liabilities and stockholders’ equity

 

$

238,358

 

 

$

266,181

 

 

See accompanying notes to unaudited condensed financial statements.

2


 

Tyra Biosciences, Inc.
Condensed Statements of Operations and Comprehensive Loss

(unaudited)
(in thousands, except share and per share data)

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

19,271

 

 

$

10,915

 

 

$

41,841

 

 

$

32,608

 

General and administrative (including related
   party amounts of $
0, $173, $0 and $570,
   respectively)

 

 

4,692

 

 

 

2,730

 

 

 

12,470

 

 

 

11,301

 

Total operating expenses

 

 

23,963

 

 

 

13,645

 

 

 

54,311

 

 

 

43,909

 

Loss from operations

 

 

(23,963

)

 

 

(13,645

)

 

 

(54,311

)

 

 

(43,909

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

2,816

 

 

 

1,131

 

 

 

8,035

 

 

 

1,496

 

Other income (expense)

 

 

(5

)

 

 

5

 

 

 

(28

)

 

 

(17

)

Total other income, net

 

 

2,811

 

 

 

1,136

 

 

 

8,007

 

 

 

1,479

 

Net loss and comprehensive loss

 

$

(21,152

)

 

$

(12,509

)

 

$

(46,304

)

 

$

(42,430

)

Net loss per share, basic and diluted

 

$

(0.49

)

 

$

(0.30

)

 

$

(1.09

)

 

$

(1.02

)

Weighted-average shares used to compute net loss
   per share, basic and diluted

 

 

42,868,340

 

 

 

41,997,195

 

 

 

42,619,075

 

 

 

41,777,052

 

 

See accompanying notes to unaudited condensed financial statements.

3


 

Tyra Biosciences, Inc.

Condensed Statements of Stockholders’ Equity

(unaudited)

(in thousands, except share amounts)

 

 

 

Common Stock

 

 

Additional
Paid-In
Capital

 

 

Accumulated
Deficit

 

 

Total
Stockholders’
Equity

 

 

 

Shares

 

 

Amount

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2021

 

 

41,441,135

 

 

$

4

 

 

$

342,104

 

 

$

(40,371

)

 

$

301,737

 

Issuance of common stock under
   benefit plans

 

 

28,951

 

 

 

 

 

 

238

 

 

 

 

 

 

238

 

Vesting of shares of common
   stock subject to repurchase

 

 

226,478

 

 

 

 

 

 

63

 

 

 

 

 

 

63

 

Stock-based compensation

 

 

 

 

 

 

 

 

3,972

 

 

 

 

 

 

3,972

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(14,826

)

 

 

(14,826

)

Balance at March 31, 2022

 

 

41,696,564

 

 

$

4

 

 

$

346,377

 

 

$

(55,197

)

 

$

291,184

 

Issuance of common stock under
   benefit plans

 

 

15,247

 

 

 

 

 

 

34

 

 

 

 

 

 

34

 

Vesting of shares of common
   stock subject to repurchase

 

 

191,299

 

 

 

 

 

 

42

 

 

 

 

 

 

42

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,688

 

 

 

 

 

 

2,688

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(15,095

)

 

 

(15,095

)

Balance at June 30, 2022

 

 

41,903,110

 

 

$

4

 

 

$

349,141

 

 

$

(70,292

)

 

$

278,853

 

Issuance of common stock under
   benefit plans

 

 

52,477

 

 

 

 

 

 

356

 

 

 

 

 

 

356

 

Vesting of shares of common
   stock subject to repurchase

 

 

181,384

 

 

 

 

 

 

37

 

 

 

 

 

 

37

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,019

 

 

 

 

 

 

1,019

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(12,509

)

 

 

(12,509

)

Balance at September 30, 2022

 

 

42,136,971

 

 

$

4

 

 

$

350,553

 

 

$

(82,801

)

 

$

267,756

 

 

4


 

 

 

 

Common Stock

 

 

Additional
Paid-In
Capital

 

 

Accumulated
Deficit

 

 

Total
Stockholders’
Equity

 

 

 

Shares

 

 

Amount

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2022

 

 

42,353,550

 

 

$

4

 

 

$

353,521

 

 

$

(95,696

)

 

$

257,829

 

Issuance of common stock under
   benefit plans

 

 

129,669

 

 

 

 

 

 

376

 

 

 

 

 

 

376

 

Vesting of shares of common
   stock subject to repurchase

 

 

52,155

 

 

 

 

 

 

32

 

 

 

 

 

 

32

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,433

 

 

 

 

 

 

2,433

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(11,880

)

 

 

(11,880

)

Balance at March 31, 2023

 

 

42,535,374

 

 

$

4

 

 

$

356,362

 

 

$

(107,576

)

 

$

248,790

 

Issuance of common stock under
   benefit plans

 

 

230,502

 

 

 

 

 

 

494

 

 

 

 

 

 

494

 

Vesting of shares of common
   stock subject to repurchase

 

 

51,357

 

 

 

 

 

 

31

 

 

 

 

 

 

31

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,529

 

 

 

 

 

 

2,529

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(13,272

)

 

 

(13,272

)

Balance at June 30, 2023

 

 

42,817,233

 

 

$

4

 

 

$

359,416

 

 

$

(120,848

)

 

$

238,572

 

Issuance of common stock under
   benefit plans

 

 

60,763

 

 

 

 

 

 

343

 

 

 

 

 

 

343

 

Vesting of shares of common
   stock subject to repurchase

 

 

50,888

 

 

 

 

 

 

30

 

 

 

 

 

 

30

 

Stock-based compensation

 

 

 

 

 

 

 

 

4,377

 

 

 

 

 

 

4,377

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(21,152

)

 

 

(21,152

)

Balance at September 30, 2023

 

 

42,928,884

 

 

$

4

 

 

$

364,166

 

 

$

(142,000

)

 

$

222,170

 

See accompanying notes to unaudited condensed financial statements.

5


 

Tyra Biosciences, Inc.

Condensed Statements of Cash Flows

(unaudited)

(in thousands)

 

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(46,304

)

 

$

(42,430

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation

 

 

251

 

 

 

214

 

Stock-based compensation

 

 

9,339

 

 

 

7,679

 

Loss on disposal of property and equipment

 

 

4

 

 

 

3

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(3,910

)

 

 

(5,945

)

Accounts payable, accrued expenses and other liabilities (including
   related party amounts of $
0 and $17, respectively)

 

 

4,293

 

 

 

2,150

 

Right-of-use assets and lease liabilities, net

 

 

(280

)

 

 

24

 

Net cash used in operating activities

 

 

(36,607

)

 

 

(38,305

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(167

)

 

 

(538

)

Net cash used in investing activities

 

 

(167

)

 

 

(538

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from issuances of common stock under benefit plans

 

 

1,213

 

 

 

629

 

Net cash provided by financing activities

 

 

1,213

 

 

 

629

 

Net cash decrease for the period

 

 

(35,561

)

 

 

(38,214

)

Cash, cash equivalents and restricted cash at beginning of the period

 

 

252,213

 

 

 

302,425

 

Cash, cash equivalents and restricted cash at end of the period

 

$

216,652

 

 

$

264,211

 

Reconciliation of cash, cash equivalents and restricted cash to the
   balance sheet

 

 

 

 

 

 

Cash and cash equivalents

 

$

215,652

 

 

$

263,211

 

Restricted cash

 

 

1,000

 

 

 

1,000

 

Total cash, cash equivalents and restricted cash

 

$

216,652

 

 

$

264,211

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

Right-of-use asset obtained in exchange for lease liability

 

$

4,004

 

 

$

1,556

 

Non-cash investing and financing activities:

 

 

 

 

 

 

Purchases of equipment included in accounts payable and accrued expenses

 

$

146

 

 

$

9

 

Vesting of options early exercised subject to repurchase

 

$

93

 

 

$

142

 

See accompanying notes to unaudited condensed financial statements.

6


 

Tyra Biosciences, Inc.

Notes to the Condensed Financial Statements

(unaudited)

1. Organization and Basis of Presentation

Organization

Tyra Biosciences, Inc. (the Company) was incorporated in the state of Delaware on August 2, 2018. The Company is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology. The Company’s in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. The Company’s initial focus is on applying accelerated small molecule drug discovery engine to develop therapies in targeted oncology and genetically defined conditions.

Basis of Presentation

The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States (GAAP) for interim financial information and pursuant to the instructions of the Securities and Exchange Commission (SEC) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB). The unaudited condensed financial statements include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows. The results for the three and nine months ended September 30, 2023 and 2022 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period. The condensed balance sheet at September 30, 2023 has been derived from the financial statements at that date but does not include all disclosures required by GAAP for complete financial statements. Because all of the disclosures required by GAAP for complete financial statements are not included herein, these unaudited condensed financial statements and the notes accompanying them should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.

2. Summary of Significant Accounting Policies

During the three and nine months ended September 30, 2023, there have been no changes to the Company's significant accounting policies as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.

Restricted Cash

Restricted cash is comprised of cash that is restricted as to its withdrawal or use under the terms of certain contractual agreements. Restricted cash as of both September 30, 2023 and December 31, 2022 was $1.0 million, which consisted of collateral for letters of credit related to the Company’s operating leases which are considered a non-current asset on the condensed balance sheets.

Commitments and Contingencies

The Company recognizes a liability with regard to loss contingencies when it believes it is probable a liability has been incurred, and the amount can be reasonably estimated. If some amount within a range of loss appears at the time to be a better estimate than any other amount within the range, the Company accrues that amount. When no amount within the range is a better estimate than any other amount the Company accrues the minimum amount in the range.

7


 

Related Parties

Transactions between related parties are considered to be related party transactions even though they may not be given accounting recognition. FASB ASC 850, Related Party Disclosures (FASB ASC 850) requires that transactions with related parties that would make a difference in decision making shall be disclosed so that users of the financial statements can evaluate their significance. Related party transactions typically occur within the context of the following relationships:

Affiliates of the entity;
Entities for which investments in their equity securities is typically accounted for under the equity method by the investing entity;
Trusts for the benefit of employees;
Principal owners of the entity and members of their immediate families;
Management of the entity and members of their immediate families; or
Other parties that can significantly influence the management or operating policies of the transacting parties and can significantly influence the other to an extent that one or more of the transacting parties might be prevented from fully pursuing its own separate interests.

The Company previously entered into a consulting agreement with van den Boom & Associates, LLC (van den Boom & Associates), a professional services firm contracted to provide resources to assist with day-to-day accounting functions. Services provided under the agreement with van den Boom & Associates are billed at hourly rates. On April 16, 2021, Ms. van den Boom, the managing partner of van den Boom & Associates, entered into an employment agreement with the Company whereby she became its Chief Financial Officer. Van den Boom & Associates is considered a related party under FASB ASC 850 from the point in which Ms. van den Boom became a Company officer. On October 28, 2022, Ms. van den Boom informed the Company of her intent to resign as the Chief Financial Officer, effective December 31, 2022. Effective January 1, 2023, van den Boom & Associates is no longer considered a related party.

Recently Issued Accounting Pronouncements

In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"). ASU 2016-13 changes the impairment model for most financial assets and certain other instruments. Under the new guidance, credit losses for certain types of financial instruments will be estimated based on expected losses. The new guidance also modifies the impairment models for available-for-sale debt securities and for purchased financial assets with credit deterioration since their origination. In November 2019, the FASB issued ASU No. 2019-10, which changed the effective date of ASU 2016-13 for smaller reporting companies to fiscal years beginning after December 15, 2022, including interim periods. This update was effective for the Company beginning January 1, 2023. The adoption of this new standard did not have a material impact on the Company's financial statements.

There were no other significant updates not already disclosed in the Company’s audited financial statements for the years ended December 31, 2022 and 2021 to the recently issued accounting standards for the three and nine months ended September 30, 2023. Although there were several other new accounting pronouncements issued or proposed by the FASB, the Company does not believe any of those accounting pronouncements have had or will have a material impact on its financial position or operating results.

3. Fair Value Measurements

The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

Level 1—Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;

8


 

Level 2—Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and

Level 3—Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e. supported by little or no market activity).

The carrying amounts of the Company’s financial instruments, including cash and cash equivalents, prepaid and other current assets, restricted cash, accounts payable, and accrued and other current liabilities, approximate fair value due to their short maturities.

Assets measured at fair value on a recurring basis are as follows (in millions):

 

 

 

 

 

 

Fair Value Measurements Using

 

 

 

As of September 30, 2023

 

 

Quoted Prices in Active Markets for Identical Assets
(Level 1)

 

 

Significant Other Observable Inputs
(Level 2)

 

 

Significant Unobservable Inputs
(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash and Cash Equivalents

 

$

215.7

 

 

$

215.7

 

 

$

 

 

$

 

Restricted Cash

 

 

1.0

 

 

 

1.0

 

 

 

 

 

 

 

Total assets

 

$

216.7

 

 

$

216.7

 

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair Value Measurements Using

 

 

 

As of December 31, 2022

 

 

Quoted Prices in Active Markets for Identical Assets
(Level 1)

 

 

Significant Other Observable Inputs
(Level 2)

 

 

Significant Unobservable Inputs
(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash and Cash Equivalents

 

$

251.2

 

 

$

251.2

 

 

$

 

 

$

 

Restricted Cash

 

 

1.0

 

 

 

1.0

 

 

 

 

 

 

 

Total assets

 

$

252.2

 

 

$

252.2

 

 

$

 

 

$

 

None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis.

4. Property and Equipment

Property and equipment consisted of the following (in thousands):

 

 

 

September 30,
2023

 

 

December 31,
2022

 

Equipment

 

$

1,244

 

 

$

1,119

 

Computers and software

 

 

196

 

 

 

181

 

Leasehold improvements

 

 

310

 

 

 

156

 

Furniture and fixtures

 

 

103

 

 

 

82

 

 

 

1,853

 

 

 

1,538

 

Less: accumulated depreciation

 

 

(706

)

 

 

(461

)

Total property and equipment, net

 

$

1,147

 

 

$

1,077

 

The Company recognized $0.1 million and $0.3 million in depreciation expense for the three and nine months ended September 30, 2023, respectively, and $0.1 million and $0.2 million in depreciation expense for the three and nine months ended September 30, 2022, respectively.

9


 

5. Accrued and Other Current Liabilities

Accrued and other current liabilities consisted of the following (in thousands):

 

 

September 30,
2023

 

 

December 31,
2022

 

Accrued payroll and other employee benefits

 

$

2,403

 

 

$

2,854

 

Accrued research and development

 

 

4,753

 

 

 

1,028

 

Accrued legal and professional fees

 

 

255

 

 

 

94

 

Accrued other general and administrative fees

 

 

280

 

 

 

440

 

Total accrued and other current liabilities

 

$

7,691

 

 

$

4,416

 

 

6. Stockholders' Equity

Common Stock

Common stock reserved for future issuance consisted of the following:

 

 

 

September 30,
2023

 

 

December 31,
2022

 

Common stock options granted and outstanding

 

 

8,110,570

 

 

 

5,890,869

 

Shares available for future issuance under the 2021
   Incentive Award Plan

 

 

3,886,847

 

 

 

4,339,373

 

Shares available for future issuance under the
   2021 Employee Stock Purchase Plan

 

 

1,129,399

 

 

 

759,442

 

Total common stock reserved for future issuance

 

 

13,126,816

 

 

 

10,989,684

 

On October 3, 2022, the Company entered into an ATM Sales Agreement (the Sales Agreement) with Virtu Americas LLC (the Agent), under which the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from the Company of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. As of September 30, 2023, no shares of common stock were issued and sold pursuant to the Sales Agreement.

Restricted Stock

 

Since inception, the Company has issued 2,820,560 shares of restricted common stock at a price of $0.0001 per share to certain founders of the Company (Founders Stock). The Company maintains a repurchase right whereby the shares of Founders Stock are released from such repurchase right over a period of time of continued service by the recipient. Any shares subject to repurchase by the Company are not deemed to be outstanding, for accounting purposes, until those shares vest. Unvested outstanding Founders Stock as of September 30, 2023 and December 31, 2022 were 1,865 and 3,828 shares, respectively. The amount recorded as liabilities associated with shares issued with repurchase rights were immaterial as of September 30, 2023 and December 31, 2022.

For the nine months ended September 30, 2023 and 2022, 1,962 and 367,410 shares vested in each period and the Company recognized $5 thousand and $0.2 million of stock-based compensation expense for each period related to the Founders Stock, respectively. As of September 30, 2023, the total unrecognized compensation expense related to unvested Founders Stock was immaterial.

7. Equity Incentive Plans and Stock-Based Compensation

Equity Incentive Plans

In September 2021, the Company's Board of Directors adopted, and its stockholders approved, the 2021 Incentive Award Plan (the 2021 Plan). Upon the adoption of the 2021 Plan, the Company restricted the grant of future equity awards under the 2020 Equity Incentive Plan (the 2020 Plan).

10


 

The 2021 Plan provides for the grants of stock options and other equity-based awards to employees, non-employee directors, and consultants of the Company. A total of 5,570,000 shares of the Company’s common stock were initially reserved for issuance pursuant to the 2021 Plan, consisting of 4,537,850 shares reserved under the 2021 Plan and 1,032,150 shares of the Company’s common stock that remained available for issuance under the 2020 Plan. The 2021 Plan share reserve will be increased by the number of shares under the 2020 Plan that are repurchased, forfeited, expired or cancelled after the effective date of the 2021 Plan. In addition, the number of shares of the Company’s common stock available for issuance under the 2021 Plan automatically increases on the first day of each fiscal year, beginning with the Company’s 2022 fiscal year, in an amount equal to the lesser of (1) 5% of the outstanding shares of the Company’s common stock on the last day of the immediately preceding fiscal year, or (2) such smaller amount as determined by the Company’s Board of Directors. As of September 30, 2023, 3,886,847 shares were available for future grant under the 2021 Plan.

A summary of the Company’s stock option activity for the period ended September 30, 2023 is as follows (in thousands, expect share and per share data and years):

 

 

 

Options

 

 

Weighted-Average
Exercise
Price per Share

 

 

Weighted-Average
Remaining
Contractual Term

 

 

Aggregate
Intrinsic Value

 

Outstanding at December 31, 2022

 

 

5,890,869

 

 

$

7.91

 

 

 

8.8

 

 

$

13,492

 

Granted

 

 

2,883,689

 

 

$

13.32

 

 

 

 

 

 

 

Exercised

 

 

(364,547

)

 

$

2.25

 

 

 

 

 

 

 

Cancelled

 

 

(299,441

)

 

$

10.29

 

 

 

 

 

 

 

Outstanding at September 30, 2023

 

 

8,110,570

 

 

$

10.00

 

 

 

8.5

 

 

$

39,978

 

Exercisable at September 30, 2023

 

 

2,721,726

 

 

$

8.07

 

 

 

7.6

 

 

$

19,786

 

Vested and expected to vest as of September 30, 2023

 

 

8,110,570

 

 

$

10.00

 

 

 

8.5

 

 

$

39,978

 

As of September 30, 2023, 67,074 performance-based stock options were both outstanding and unvested. During the three and nine months ended September 30, 2023, the Company recognized $0.7 million and $0.8 million, respectively, in expenses related to these options as the achievement of certain performance conditions was deemed probable to occur. As of September 30, 2023, the unrecognized stock-based compensation expense related to the performance-based options was $0.5 million.

Stock-Based Compensation Expense

The Company estimated the fair value of stock options using the Black-Scholes valuation model. The Company accounts for forfeitures of options when they occur. Previously recognized compensation expense for an award is reversed in the period that the award is forfeited. The fair value of stock options was estimated using the following assumptions (excluding option modifications):

 

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

2022

 

Risk-free rate of interest

 

3.5 - 4.3%

 

1.6 - 3.6%

 

Expected term (years)

 

5.2 - 6.1

 

5.1 - 6.1

 

Expected stock price volatility

 

87.0 - 92.3%

 

82.3 - 90.4 %

 

Dividend yield

 

 

 

Stock-based compensation expense recognized for all equity awards has been reported in the condensed statements of operations and comprehensive loss as follows (in thousands):

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Research and development expense

 

$

2,811

 

 

$

651

 

 

$

5,749

 

 

$

3,732

 

General and administrative expense

 

 

1,566

 

 

 

368

 

 

 

3,590

 

 

 

3,947

 

Total

 

$

4,377

 

 

$

1,019

 

 

$

9,339

 

 

$

7,679

 

 

The weighted-average grant date fair value of options granted for the nine months ended September 30, 2023 and 2022 was $10.01 and $5.59 per share, respectively.

 

11


 

For nine months ended September 30, 2023, forfeitures resulted in the reversal of compensation expense totaling $0.1 million. For nine months ended September 30, 2022, forfeitures resulted in the reversal of compensation expense totaling $1.1 million, of which $1.0 million related to compensation expense for performance-based options, previously recorded in 2022.

 

As of September 30, 2023, the unrecognized compensation cost related to outstanding employee and nonemployee options was $42.3 million, and is expected to be recognized as expense over a weighted-average period of approximately 2.6 years.

 

Employee Stock Purchase Plan

 

In September 2021, the Company’s Board of Directors and stockholders approved and adopted the 2021 Employee Stock Purchase Plan (ESPP). The ESPP became effective on the business day immediately prior to the effective date of the Company’s first registration statement. A total of 380,000 shares of the Company’s common stock were initially reserved for issuance pursuant to the ESPP. In addition, the number of shares of the Company’s common stock available for issuance under the ESPP will automatically increase on the first day of each fiscal year, beginning with the Company’s 2022 fiscal year, in an amount equal to the lesser of (1) 1% of the outstanding shares of the Company’s common stock on the last day of the immediately preceding fiscal year, or (2) such smaller amount as determined by the Company’s Board of Directors. On January 1, 2022, the number of shares reserved for issuance under the ESPP was increased to 805,361 shares and on January 1, 2023, the number of shares reserved for issuance under the ESPP was increased to 1,231,705 shares.

 

The ESPP permits eligible employees who elect to participate in an offering under the ESPP to have up to 15% of their eligible earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the ESPP. The price of common stock purchased under the ESPP is equal to 85% of the lower of the fair market value of the common stock at the commencement date of each offering period or the relevant date of purchase. Each offering period is 24 months, with new offering periods commencing every six months on or about the dates of March 15 and September 15 of each year. During the nine months ended September 30, 2023 and 2022, the Company issued 56,387 and 45,919 shares, respectively, of common stock in connection with the ESPP. As of September 30, 2023, there were 1,129,399 shares available for future purchase under the ESPP.

 

The Company recognized compensation expense of $0.1 million and $0.1 million for the three months ended September 30, 2023 and 2022, respectively, and $0.4 million and $0.4 million for the nine months ended September 30, 2023 and 2022, respectively, related to the ESPP. As of September 30, 2023, the remaining unrecognized compensation expense related to the ESPP was $0.3 million, and is expected to be recognized as expense over a weighted-average period of approximately 1.2 years.

Liability for Early Exercise of Stock Options

Certain individuals were granted the ability to early exercise their stock options prior to the IPO. The shares of common stock issued from the early exercise of unvested stock options are restricted and continue to vest in accordance with the original vesting schedule. The Company has the option to repurchase any unvested shares at the original purchase price upon any voluntary or involuntary termination. The shares purchased by the employees and non-employees pursuant to the early exercise of stock options are not deemed, for accounting purposes, to be outstanding until those shares vest. The cash received in exchange for exercised and unvested shares related to stock options granted is recorded as a liability for the early exercise of stock options on the accompanying condensed balance sheets and will be transferred into common stock and additional paid-in capital as the shares vest. As of September 30, 2023 and December 31, 2022, 124,644 and 277,081 unvested shares issued under early exercise provisions were subject to repurchase by the Company, respectively. As of September 30, 2023 and December 31, 2022, the Company recorded $0.1 million and $0.2 million, respectively, associated with early exercised stock options in other long-term liabilities.

12


 

8. Net Loss Per Share

The following table sets forth the computation of the basic and diluted net loss per share (in thousands, except share and per share amounts):

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(21,152

)

 

$

(12,509

)

 

$

(46,304

)

 

$

(42,430

)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding

 

 

43,020,965

 

 

 

42,646,810

 

 

 

42,822,677

 

 

 

42,614,902

 

Less: weighted-average unvested restricted common stock subject to repurchase

 

 

(2,107

)

 

 

(209,421

)

 

 

(2,762

)

 

 

(330,928

)

Less: weighted-average unvested common stock issued upon early exercise of common stock options

 

 

(150,518

)

 

 

(440,194

)

 

 

(200,840

)

 

 

(506,922

)

Weighted-average shares used to compute net loss per common share, basic and diluted

 

 

42,868,340

 

 

 

41,997,195

 

 

 

42,619,075

 

 

 

41,777,052

 

Net loss per share, basic and diluted

 

$

(0.49

)

 

$

(0.30

)

 

$

(1.09

)

 

$

(1.02

)

 

The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because their inclusion would be anti-dilutive.

 

 

 

As of September 30,

 

 

 

2023

 

 

2022

 

Unvested restricted common stock subject to repurchase

 

 

1,865

 

 

 

127,760

 

Unvested common stock upon early exercise of stock
   options

 

 

124,644

 

 

 

368,127

 

Options to purchase common stock

 

 

8,110,570

 

 

 

5,948,170

 

 

 

8,237,079

 

 

 

6,444,057

 

 

9. Leases

The Company has operating leases for its office and laboratory space, including its corporate headquarters.

In August 2020, the Company entered into a lease agreement for approximately 4,734 square feet of office and lab space at 2656 State Street in Carlsbad, California, for the Company’s headquarters (the Original Lease). The Original Lease commenced in May 2021, and had an original term of 60 months, with an option to extend for two additional 36 month periods.

In March 2022, the Company entered into a lease agreement for approximately 7,377 square feet of additional office and laboratory space at 2676 State Street in Carlsbad, California (the Expansion Lease). The Expansion Lease commenced for accounting purposes when the Company gained access to the premises in May 2023. The Company's obligation for payment of base rent begins on the date the landlord delivers possession of the Expansion Lease premises, estimated to occur in November 2023. The landlord is completing improvements on the Expansion Lease premises, and the Company paid $0.5 million of these costs prior to the Expansion Lease commencement. The Company has concluded that the landlord is the accounting owner of these improvements, and therefore this payment has been included in the calculation of the right-of-use asset and lease liability. The Company is entitled to certain rent abatement for delays related to the landlord's delivery of the Expansion Lease premises to the Company. The Expansion Lease has a lease term of 120 months, starting on the day the landlord delivers possession of the Expansion Lease premises. The Company has an option to renew the Expansion Lease for two additional 36 month periods. The Original Lease was also amended to have the same lease expiration as the Expansion Lease.

The Company did not include the renewal periods in determining the lease term, as the Company was not reasonably certain to exercise either the amended Original Lease or the Expansion Lease renewal options.

In connection with the Company's lease agreements, the Company paid security deposits of $0.1 million and is required to maintain a letter of credit of $1.0 million until 2027 at which time it can be reduced to $0.5 million throughout the end of the lease term.

13


 

Cash paid for amounts included in the measurement of lease liabilities was $0.1 million and $0.1 million for the three months ended September 30, 2023 and 2022, respectively, and $0.8 million and $0.2 million for the nine months ended September 30, 2023 and 2022, respectively.

The components of lease expense include operating, short-term, and variable lease costs. Amortization is recorded within research and development and general and administrative expenses in the condensed statements of operations and comprehensive loss. Components of lease cost for the three and nine months ended September 30, 2023 and 2022, respectively, were as follows (in thousands):

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating lease cost

 

$

227

 

 

$

83

 

 

$

473

 

 

$

239

 

Short-term lease cost

 

 

19

 

 

 

21

 

 

 

39

 

 

 

60

 

Variable lease cost

 

 

19

 

 

 

16

 

 

 

53

 

 

 

46

 

Total lease cost

 

$

265

 

 

$

120

 

 

$

565

 

 

$

345

 

Maturities of lease liabilities, weighted-average remaining term and weighted-average discount rate were as follows (in thousands):

 

 

 

As of September 30,

 

Year ending December 31,

 

 

 

2023 (remaining three months)

 

$

76

 

2024

 

 

717

 

2025

 

 

827

 

2026

 

 

852

 

2027

 

 

877

 

Thereafter

 

 

5,667

 

Total minimum lease payments

 

 

9,016

 

Less: amount representing interest

 

 

(2,904

)

Present value of lease liabilities

 

 

6,112

 

Less: current portion of lease liabilities

 

 

(148

)

Lease liabilities, noncurrent

 

$

5,964

 

 

 

 

September 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Weighted-average remaining lease term (years) - operating leases

 

 

10.1

 

 

 

10.5

 

Weighted-average incremental borrowing rate - operating leases

 

 

8.03

%

 

 

6.50

%

 

10. Commitments and Contingencies

Other Funding Commitments

As of September 30, 2023, the Company had ongoing clinical and pre-clinical studies for its various pipeline programs. The Company enters into contracts in the normal course of business with contract research organizations in preparation for clinical trials, professional consultants for expert advice and other vendors for clinical supply manufacturing or other services. These contracts are generally cancellable, with notice, at the Company's option and do not have significant cancellation penalties.

Litigation

The Company, from time to time, may be party to litigation arising in the ordinary course of business. The Company was not subject to any material legal proceedings as of September 30, 2023, and no material legal proceedings are currently pending or threatened. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount is reasonably estimable, the Company will accrue a liability for the estimated loss.

14


 

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

The following discussion and analysis and the unaudited interim condensed financial statements included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2022 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in the Annual Report on Form 10-K for the year ended December 31, 2022 (the 2022 Annual Report).

Forward-Looking Statements

This Quarterly Report on Form 10-Q (Quarterly Report) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing and phase of development, costs, design and conduct of our ongoing and planned preclinical studies and clinical trials for our product candidates, the timing and likelihood of regulatory filings and approvals for our product candidates, the potential to develop product candidates and the safety and therapeutic benefits of our product candidates, our ability to commercialize our product candidates, if approved, the pricing and reimbursement of our product candidates, if approved, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target” “will” or “would” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions, including, without limitation, the risk factors described in Part II, Item 1A, “Risk Factors” of this Quarterly Report. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Overview

We are a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology. Our in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. Our initial focus is on applying our accelerated small molecule drug discovery engine to develop therapies in targeted oncology and genetically defined conditions.

In oncology, the widespread availability of approved targeted treatments, such as kinase inhibitors, has transformed the cancer treatment landscape. Despite the therapeutic benefit that targeted oncology treatments have created for some patients, the response rate and duration of efficacy is often limited by acquired drug resistance, off-target toxicities and other shortcomings of existing therapies. We are using our proprietary SNÅP platform, which is optimized to enable rapid and precise refinement of structural design through iterative molecular SNÅPshots, in order to generate novel product candidates that are specifically designed to limit off-target toxicities and address acquired drug resistance to provide next-generation treatment options. Genomic alterations in FGFR family members occur in approximately 7% of all human cancers, representing about 126,000 new cases per year.

We are advancing multiple oncology product candidates toward the clinic, including our lead product candidate TYRA-300, an FGFR3 selective inhibitor with an initial focus on patients with metastatic urothelial carcinoma of the bladder and urinary tract (mUC). We submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for TYRA-300 in June 2022 and received clearance in July 2022 to proceed with our Phase 1/2 clinical trial of TYRA-300, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors), a multi-center, open label study designed to determine the optimal and maximum tolerated doses and the recommended Phase 2 dose of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. In November 2022, the first patient was dosed with TYRA-300 in our Phase 1/2 study SURF301.

15


 

Beyond oncology, FGFR3 is implicated in many developmental conditions, such as achondroplasia (ACH) and other skeletal dysplasias, due to its role in regulating bone and cartilage formation. In March 2023, we announced we were expanding development of TYRA-300 into achondroplasia based on positive preclinical results demonstrated in a study performed in collaboration with the Imagine Institute in Paris, France. Data from the study showed that TYRA-300 increased body length in mice by 17.9% compared to the vehicle (p<0.0001) and increased the length of the femur (+22.6%), tibia (+33.0%) and L4-L6 (+23.5%) in mice (p<0.0001) (with n=8 for TYRA-300, after excluding two mice from dataset when molecular analysis showed chimeric incorporation of mutation, and n=10 for vehicle, after excluding one vehicle mouse). Achondroplasia, the most common form of dwarfism, is a skeletal dysplasia in which growth plate cartilage is affected, resulting in decreased growth of the long bones, vertebral bodies and skull base. These growth differences can result in health complications such as cranial and spinal stenosis, hydrocephalus, genu varum (bowed legs), and sleep apnea. A specific mutation in FGFR3 causes an estimated 99% of achondroplasia. We believe that the design of TYRA-300 may have a meaningful impact on achondroplasia and other skeletal dysplasias. We are conducting additional IND-enabling studies and anticipate submitting an IND to the FDA to enable a Phase 2 study in pediatric achondroplasia in 2024. In July 2023, the FDA granted TYRA-300 Orphan Drug Designation (ODD) for the treatment of achondroplasia.

We are also advancing our second oncology product candidate, TYRA-200, an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations, as well as clinically important molecular brake and gatekeeper resistance mutations. In December 2022, we submitted an IND to the FDA for TYRA-200 and received clearance in January 2023 to proceed with a Phase 1 clinical trial of TYRA-200, which will be focused on intrahepatic cholangiocarcinoma resistant to other FGFR inhibitors. We anticipate dosing the first patient in this trial by the end of 2023.

Since the commencement of our operations in 2018, we have devoted substantially all of our resources to organizing and staffing the company, business planning, raising capital, developing our proprietary SNÅP platform, undertaking research and development activities for our development programs, establishing our intellectual property portfolio, and providing general and administrative support for our operations. We have not generated any revenue to date and have funded our operations primarily from our initial public offering (IPO), private placements of our convertible preferred stock, and the issuance of Simple Agreements for Future Equity. Our net losses for the nine months ended September 30, 2023 and 2022 were $46.3 million and $42.4 million, respectively. As of September 30, 2023, we had an accumulated deficit of $142.0 million. As of September 30, 2023, we had cash and cash equivalents of $215.7 million.

We have incurred significant operating losses since inception. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical development activities, other research and development activities and capital expenditures. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future particularly if and as we conduct preclinical studies and clinical trials, continue our research and development activities, utilize third parties to manufacture our product candidates and related raw materials, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company.

Based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditures through at least 2024. We have never generated any revenue and do not expect to generate any revenues from product sales unless and until we successfully complete development of and obtain regulatory approval for our product candidates, which will not be for several years, if ever. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. If we are unable to raise additional capital or enter into such arrangements when needed, we could be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

16


 

Components of Results of Operations

Operating Expenses

Research and Development Expenses

To date, our research and development expenses consist primarily of external and internal costs related to the development of our SNÅP platform and our product candidates and development programs. Our research and development expenses primarily include:

external costs, including:
expenses incurred in connection with conducting clinical trials, including investigator grants and site payments for time and pass-through expenses and expenses incurred under agreements with contract research organizations (CROs), central laboratories and other vendors and service providers engaged to conduct our trials;
expenses incurred in connection with the discovery and preclinical development of our product candidates, including under agreements with third parties, such as consultants and CROs;
costs associated with consultants for chemistry, manufacturing and controls (CMC) development, and other services;
the cost of manufacturing compounds for use in our preclinical studies, including under agreements with third parties, such as consultants and third-party manufacturers; and
costs related to compliance with drug development regulatory requirements; and
internal costs, including:
employee-related expenses, including salaries, related benefits, travel and share-based compensation expenses for employees engaged in research and development functions;
the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study materials; and
facilities, depreciation and other expenses, which include allocated expenses for rent and maintenance of facilities, and supplies.

We expense research and development expenses in the periods in which they are incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. We track external expenses on a development program and other program specific basis. However, we do not track internal costs on a program specific basis because these costs primarily relate to compensation, early research and consumable costs, which are deployed across multiple programs under development.

Research and development activities are central to our business model. There are numerous factors associated with the successful development of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of development generally have higher development costs than those in earlier stages of development. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance our product candidates through preclinical studies into and through clinical trials, continue to discover and develop additional product candidates and expand our pipeline, maintain, expand, protect and enforce our intellectual property portfolio, and hire additional personnel.

Our future research and development expenses may vary significantly based on a wide variety of factors such as:

the number and scope, rate of progress, expense and results of our discovery and preclinical development activities and clinical trials;
the number of trials required for approval;

17


 

the number of sites included in each of our trials;
the countries in which the trials are conducted;
the length of time required to enroll eligible patients;
the number of patients that participate in the trials;
the ability to identify appropriate patients eligible for our clinical trials;
the number of doses that patients receive;
the drop-out or discontinuation rates of patients;
potential additional safety monitoring requested by regulatory agencies;
the duration of patient participation in the trials and follow-up;
the phase of development of the product candidate;
the efficacy and safety profile of the product candidate;
the timing, receipt, and terms of any approvals from applicable regulatory authorities including the FDA and non-U.S. regulators;
maintaining a continued acceptable safety profile of our product candidates following approval, if any;
the cost and timing of manufacturing our product candidates;
significant and changing government regulation and regulatory guidance;
the impact of any business interruptions to our operations or to those of the third parties with whom we work,
geopolitical instability, such as the war in Ukraine and, more recently, the war between Israel and Hamas;
adverse effects on the financial markets, the global economy, the supply chain and our expenses due to pandemics or other epidemic diseases, geopolitical instability, inflation, rising interest rates and other factors; and
the extent to which we establish additional strategic collaborations or other arrangements.

A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate.

The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our product candidates or any future candidates may be affected by a variety of factors. We may never succeed in achieving regulatory approval for any of our product candidates or any future candidates.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel-related expenses, including employee salaries, bonuses, benefits, and stock-based compensation charges, for personnel in executive and administrative functions. Other significant general and administrative expenses include legal fees relating to intellectual property and corporate matters, professional fees for accounting, tax and consulting services and insurance costs. We expect our general and administrative expenses will increase for the foreseeable future to support our increased research and development activities, manufacturing activities, and the increased costs associated with operating as a public company. These increased costs will likely include increased expenses related to hiring of additional personnel, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and the Securities and Exchange Commission (SEC) requirements, director and officer insurance costs, and investor and public relations costs.

18


 

Other Income and Expense

Other income (expense) consists primarily of interest income from our cash and cash equivalents.

Results of Operations

Comparison of the Three Months Ended September 30, 2023 and 2022

The following table summarizes our results of operations for the periods indicated (in thousands):

 

 

 

Three Months Ended September 30,

 

 

 

 

 

 

2023

 

 

2022

 

 

Change

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

19,271

 

 

$

10,915

 

 

$

8,356

 

General and administrative

 

 

4,692

 

 

 

2,730

 

 

 

1,962

 

Total operating expenses

 

 

23,963

 

 

 

13,645

 

 

 

10,318

 

Loss from operations

 

 

(23,963

)

 

 

(13,645

)

 

 

(10,318

)

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest income

 

 

2,816

 

 

 

1,131

 

 

 

1,685

 

Other income (expense)

 

 

(5

)

 

 

5

 

 

 

(10

)

Total other income, net

 

 

2,811

 

 

 

1,136

 

 

 

1,675

 

Net loss and comprehensive loss

 

$

(21,152

)

 

$

(12,509

)

 

$

(8,643

)

 

Research and Development Expenses

Research and development expenses were $19.3 million and $10.9 million for the three months ended September 30, 2023 and 2022, respectively. The overall increase of $8.4 million was primarily due to an increase in CRO and drug manufacturing costs to support our ongoing and planned clinical trials of $5.9 million, an increase in stock-based compensation costs of $2.2 million, an increase in compensation costs of $1.3 million, and an increase in facilities and other operating costs of $0.3 million. The increase was partially offset by a decrease in preclinical expenses of $1.3 million.

The following table summarizes our research and development expenses by development program for the three months ended September 30, 2023 and 2022 (in thousands):

 

 

 

Three Months Ended September 30,

 

 

 

2023

 

 

2022

 

External research and development expense by
   program

 

 

 

 

 

 

TYRA-300 ONC

 

$

4,797

 

 

$

2,844

 

TYRA-200

 

 

1,626

 

 

 

1,770

 

TYRA-300 ACH

 

 

2,176

 

 

 

816

 

RET

 

 

101

 

 

 

966

 

FGFR4

 

 

1,819

 

 

 

463

 

Other development programs

 

 

1,679

 

 

 

831

 

Unallocated research and development expense

 

 

 

 

 

 

Other research and development

 

 

1,308

 

 

 

923

 

Compensation and stock-based compensation

 

 

5,765

 

 

 

2,302

 

Total research and development expense

 

$

19,271

 

 

$

10,915

 

 

General and Administrative Expenses

General and administrative expenses were $4.7 million and $2.7 million for the three months ended September 30, 2023 and 2022, respectively. The increase of $2.0 million was primarily due to an increase in stock-based compensation costs of $1.2 million, an increase in professional services costs of $0.6 million, and an increase in compensation costs of $0.3 million. The increase was partially offset by a decrease in facilities and other operating costs of $0.1 million.

 

19


 

Other Income

Other income was $2.8 million and $1.1 million for the three months ended September 30, 2023 and 2022, respectively. The increase of $1.7 million was primarily related to an increase in interest rate return on our cash and cash equivalents.

Comparison of the Nine Months Ended September 30, 2023 and 2022

The following table summarizes our results of operations for the periods indicated (in thousands):

 

 

 

Nine Months Ended September 30,

 

 

 

 

 

 

2023

 

 

2022

 

 

Change

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

41,841

 

 

$

32,608

 

 

$

9,233

 

General and administrative

 

 

12,470

 

 

 

11,301

 

 

 

1,169

 

Total operating expenses

 

 

54,311

 

 

 

43,909

 

 

 

10,402

 

Loss from operations

 

 

(54,311

)

 

 

(43,909

)

 

 

(10,402

)

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest income

 

 

8,035

 

 

 

1,496

 

 

 

6,539

 

Other expense

 

 

(28

)

 

 

(17

)

 

 

(11

)

Total other income, net

 

 

8,007

 

 

 

1,479

 

 

 

6,528

 

Net loss and comprehensive loss

 

$

(46,304

)

 

$

(42,430

)

 

$

(3,874

)

 

Research and Development Expenses

Research and development expenses were $41.8 million and $32.6 million for the nine months ended September 30, 2023 and 2022, respectively. The overall increase of $9.2 million was primarily due to an increase in CRO and drug manufacturing costs to support our ongoing and planned clinical trials of $6.1 million, an increase of compensation costs of $2.3 million, an increase of stock-based compensation costs of $2.0 million, and an increase in facilities and other operating costs of $0.8 million. The increase was partially offset by a decrease in preclinical expenses of $2.0 million.

The following table summarizes our research and development expenses by development program for the nine months ended September 30, 2023 and 2022 (in thousands):

 

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

External research and development expense by
   program

 

 

 

 

 

 

TYRA-300 ONC

 

$

9,755

 

 

$

8,195

 

TYRA-200

 

 

3,413

 

 

 

4,634

 

FGFR3 ACH

 

 

3,153

 

 

 

2,208

 

RET

 

 

822

 

 

 

3,555

 

FGFR4

 

 

3,130

 

 

 

1,547

 

Other development programs

 

 

5,197

 

 

 

1,302

 

Unallocated research and development expense

 

 

 

 

 

 

Other research and development

 

 

3,061

 

 

 

2,218

 

Compensation and stock-based compensation

 

 

13,310

 

 

 

8,949

 

Total research and development expense

 

$

41,841

 

 

$

32,608

 

 

General and Administrative Expenses

General and administrative expenses were $12.5 million and $11.3 million for the nine months ended September 30, 2023 and 2022, respectively. The increase of $1.2 million was primarily due to an increase in compensation costs of $0.8 million, an increase in professional services costs of $0.5 million, and an increase in facilities and other operating costs of $0.3 million. The increase was partially offset by a decrease in stock-compensation costs of $0.4 million.

 

Other Income

Other income was $8.0 million and $1.5 million for the nine months ended September 30, 2023 and 2022, respectively. The increase of $6.5 million was primarily related to an increase in interest rate return on our cash and cash equivalents.

20


 

Liquidity and Capital Resources

Sources of Liquidity

On September 17, 2021, we completed our IPO and issued 12,420,000 shares of common stock for net proceeds of approximately $181.2 million. Prior to our IPO, we funded our operations primarily through private placements of our convertible preferred stock with net proceeds of $157.2 million excluding issuance costs of $0.4 million.

Our primary uses of cash to date have been to fund our research and development activities, including with respect to TYRA-300 and TYRA-200 and other research programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.

On October 3, 2022, we entered into an ATM Sales Agreement (the Sales Agreement) with Virtu Americas LLC (the Agent), under which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from us of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement.

We are not obligated to sell, and the Agent is not obligated to buy or sell, any shares of common stock under the Sales Agreement. No assurance can be given that we will sell any shares of common stock under the Sales Agreement, or, if we do, as to the price or amount of shares of common stock that we may sell or the dates when such sales will take place. As of September 30, 2023, we have not sold any shares under the Sales Agreement.

Cash Flows

The following table sets forth a summary of our cash flows for the periods indicated (in thousands):

 

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

Net cash used in operating activities

 

$

(36,607

)

 

$

(38,305

)

Net cash used in investing activities

 

 

(167

)

 

 

(538

)

Net cash provided by financing activities

 

 

1,213

 

 

 

629

 

Net cash decrease for the period

 

$

(35,561

)

 

$

(38,214

)

 

Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2023 was $36.6 million, consisting primarily of our net loss of $46.3 million, adjusted for $9.6 million of non-cash charges primarily related to stock-based compensation expense and $0.1 million for net changes in operating assets and liabilities.

Net cash used in operating activities for the nine months ended September 30, 2022 was $38.3 million, consisting primarily of our net loss of $42.4 million and $3.8 million for net changes in operating assets and liabilities, adjusted for $7.9 million of non-cash charges primarily related to stock-based compensation expense and depreciation and amortization.

Investing Activities

Net cash used in investing activities for the nine months ended September 30, 2023 and 2022 was $0.2 million and $0.5 million, respectively, consisting of purchases of property and equipment.

Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2023 and 2022 was $1.2 million and $0.6 million, respectively, primarily related to proceeds from issuances of common stock under benefit plans.

21


 

Future Funding Requirements

Based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to meet our anticipated operating expenses and capital expenditures through at least 2024. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.

Our future capital requirements will depend on many factors, including:

the initiation, type, number, scope, results, costs and timing of, our ongoing and planned preclinical studies and clinical trials of existing product candidates or clinical trials of other potential product candidates we may choose to pursue in the future, including based on feedback received from regulatory authorities;
the costs and timing of manufacturing for current or future product candidates, including commercial scale manufacturing if any product candidate is approved;
the costs, timing and outcome of regulatory review of current or future product candidates;
the costs of obtaining, maintaining and enforcing our patents and other intellectual property rights;
our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting;
the costs associated with hiring additional personnel and consultants as our business grows, including additional executive officers and clinical development personnel;
the costs and timing of establishing or securing sales and marketing capabilities if any current or future product candidate is approved;
our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;
costs associated with any products or technologies that we may in-license or acquire; and
delays or issues with any of the above, including that the risk of each may be exacerbated by any future pandemics or epidemic diseases, potential geopolitical instability and war, inflation or rising interest rates.

Until such time, if ever, as we can generate substantial product revenues to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings 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 our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

Contractual Obligations and Commitments

Other than disclosed below, there were no material changes outside the ordinary course of our business during the nine months ended September 30, 2023 to the information regarding our contractual obligations that was disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2022 Annual Report.

22


 

As of September 30, 2023, total future aggregate operating lease commitments were $9.0 million, with approximately $0.1 million due in 2023, and the remaining due in periods from 2024 through 2033.

Critical Accounting Policies and Estimates

There have been no material changes to our critical accounting policies and estimates during the three and nine months ended September 30, 2023, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2022 Annual Report.

Recently Adopted Accounting Pronouncements

See Note 2 to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q for recently issued accounting pronouncements that may potentially impact our financial position and results of operations.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

As of September 30, 2023, there have been no material changes surrounding our market risk, including interest rate risk, foreign currency exchange risk, and inflation risk, from the discussion provided in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Quantitative and Qualitative Disclosures about Market Risk” in the 2022 Annual Report.

Item 4. Controls and Procedures

Our management, with the participation of our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), has evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, as of the end of the period covered by this quarterly report. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the quarter covered by this report. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

 

Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting that occurred during our most recent quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II—OTHER INFORMATION

Item 1. Legal Proceedings

We are not currently subject to any material legal proceedings. From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.

Item 1A. Risk Factors

There have been no material changes to the risk factors disclosed in Item 1A of our 2022 Annual Report.

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

Unregistered Sales of Equity Securities

None.

Use of Proceeds from Initial Public Offering

On September 14, 2021, our registration statement on Form S-1 (File No. 333-258970) was declared effective by the SEC for our IPO. At the closing of the offering on September 17, 2021, we sold 12,420,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase 1,620,000 additional shares, at an initial public offering price of $16.00 per share and received gross proceeds of $198.7 million, which resulted in net proceeds to us of approximately $181.2 million, after deducting underwriting discounts and commissions of approximately $13.9 million and offering-related transaction costs of approximately $3.6 million. None of the expenses associated with the IPO were paid to directors, officers, persons owning 10% or more of any class of equity securities, or to their associates, or to our affiliates. BofA Securities, Inc., Jefferies LLC, and Cowen and Company, LLC acted as joint book-running managers for the offering.

As of September 30, 2023, we estimate that we have used approximately $98 million of the proceeds from our IPO for general corporate purposes, including to fund the development of TYRA-300, TYRA-200 and our other development programs. There has been no material change in the planned use of proceeds from that described in the final prospectus filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act on September 15, 2021.

Issuer Repurchases of Equity Securities

None.

Item 3. Defaults Upon Senior Securities

Not applicable.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None.

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Item 6. Exhibits

 

Exhibit Number

Exhibit Description

Incorporated by Reference

Filed Herewith

Form

Date

Number

3.1

Amended and Restated Certificate of Incorporation

10-K

3/22/23

3.1

3.2

Amended and Restated Bylaws, effective as of October 26, 2023

8-K

10/26/23

3.1

4.1

Specimen stock certificate evidencing the shares of common stock

S-1

8/20/21

4.1

4.2

Amended and Restated Investors’ Rights Agreement, dated March 5, 2021, by and among the Registrant and certain of its stockholders

S-1/A

9/9/21

4.2

10.1

 

Non-Employee Director Compensation Program, amended and restated effective August 1, 2023

 

 

 

 

 

 

 

X

31.1

Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

X

31.2

Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

X

 32.1*

Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

X

 32.2*

Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

X

  101.INS

Inline XBRL Instance Document

X

  101.SCH

Inline XBRL Taxonomy Extension Schema Document

X

  101.CAL

Inline XBRL Taxonomy Calculation Linkbase Document

X

  101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

X

  101.LAB

Inline XBRL Taxonomy Label Linkbase Document

X

  101.PRE

Inline XBRL Presentation Linkbase Document

X

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

X

* This certification is deemed not filed for purpose of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.

 

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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.

 

TYRA BIOSCIENCES, INC.

Date: November 7, 2023

By:

/s/ Todd Harris, Ph.D.

Todd Harris, Ph.D.

President, Chief Executive Officer, and Director

 

 (Principal Executive Officer)

 

 

 

 

Date: November 7, 2023

By:

/s/ Alan Fuhrman

Alan Fuhrman

Chief Financial Officer

 

 

 

(Principal Financial and Accounting Officer)

 

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