8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

August 11, 2022

KINNATE BIOPHARMA INC.

(Exact name of registrant as specified in its charter)

Delaware	001-39743	82-4566526
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

103 Montgomery Street, Suite 150

The Presidio of San Francisco

San Francisco, CA 94129

(Address, including zip code, of Registrant’s principal executive offices)

(858) 299-4699

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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, par value $0.0001 per share	KNTE	The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

Item 2.02 Results of Operations and Financial Condition.

On August 11, 2022, Kinnate Biopharma Inc. issued a press release announcing its financial results for the quarter ended June 30, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release dated August 11, 2022.
104	Cover page interactive data file (embedded within the inline XBRL document).

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 hereunto duly authorized.

	KINNATE BIOPHARMA INC.
	By:	/s/ Nima Farzan
		Nima Farzan
		President and Chief Executive Officer
Date: August 11, 2022

EX-99.1

Exhibit 99.1

 

Kinnate Biopharma Inc. Announces Second Quarter 2022 Financial Results and Recent Corporate Updates

• Phase 1 clinical trial for KIN-2787, the company’s investigational pan-RAF inhibitor, was initiated in Taiwan by Kinnjiu Biopharma Inc., Kinnate’s China joint venture

• U.S. Food and Drug Administration granted Orphan Drug Designation for KIN-2787 for the treatment of stage IIb-IV melanoma

• Continued to expand clinical trial sites for KIN-2787 in the U.S. and globally

• Cash, cash equivalents and investments of approximately $279.6million as of June 30, 2022 (excluding cash from China joint venture)

SAN FRANCISCO and SAN DIEGO, Calif. – August 11, 2022 – Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate”), a clinical-stage precision oncology company, today announced financial results for the quarter ended June 30, 2022, and recent corporate updates.

“Kinnate is making meaningful progress with its proprietary clinical and preclinical precision oncology programs,” said Nima Farzan, chief executive officer, Kinnate Biopharma Inc. “We continue to expand the global footprint of clinical trial sites for our pan-RAF inhibitor, KIN-2787, for which we expect to share initial clinical data later this year. The Kinnate Discovery Engine is actively generating new research leads, and with our financial strength, we’re well positioned to invest in breakthrough science and long-term growth of the company.” 

Pipeline Updates

KIN-2787, pan-RAF Inhibitor

• Announced that KN-8701, a Phase 1 clinical trial to evaluate KIN-2787, was initiated in Taiwan by Kinnjiu Biopharma Inc., Kinnate’s China joint venture to develop and commercialize its most advanced kinase inhibitors in the People's Republic of China, Hong Kong, Macau and Taiwan.

• Granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration for KIN-2787 for the treatment of stage IIb-IV melanoma. An ODD is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S.

• Published online abstract as part of the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO) meeting proceedings on the in vitro and in vivo preclinical studies evaluating KIN-2787 in combination with binimetinib in NRAS-mutant melanoma models. (View release)

• Enrolling patients in the ongoing Phase 1 dose escalation portion of KN-8701 evaluating KIN-2787 at approximately 18 active trial sites, including in the U.S., Spain, France and Australia.  Initial monotherapy data is expected in the fourth quarter of 2022, and data for the binimetinib combination in the first half of 2023.

KIN-3248, FGFR Inhibitor

• Presented the design and rationale of KN-4802, a Phase 1 clinical trial evaluating KIN-3248, the company’s investigational FGFR inhibitor, at the 2022 ASCO Annual Meeting. (View release)

• Enrolling patients in the Phase 1 dose escalation portion of KN-4802, with initial clinical data for KIN-3248 expected in the second half of 2023.

Corporate Highlights

• Expanded the organization to 82 full-time employees as of June 30, 2022, of which 61were engaged in research and development activities.

• The following senior leaders joined the company in the second quarter:

o Robert Pelham, PhD, Vice President, Translational Medicine

o Cheng Quah, MBBS, Vice President, Clinical Development

Second Quarter 2022 Financial Results

• Cash and Cash Equivalents and Investments Position: As of June 30, 2022, the total of cash and cash equivalents and investments was $279.6 million, exclusive of Kinnjiu’s cash.

• Research and Development Expenses: Second quarter research and development expenses for 2022 were $19.8 million, compared to $16.2 million for the same period in 2021.

• General and Administrative Expenses: Second quarter general and administrative expenses for 2022 were $7.6 million, compared to $5.3 million for the same period in 2021.

• Net Loss: Second quarter net loss for 2022 was $27.1 million, compared to $21.4 million for the same period in 2021. 

About Kinnate Biopharma Inc.

Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer. The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such as non-responsiveness or acquired and intrinsic resistance. Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule drug candidates as part of the Kinnate Discovery Engine. The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines.  For more information, visit Kinnate.com and follow us on LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. These forward-looking statements include, without limitation, statements regarding the potential benefits of our product candidates, including KIN-2787 and KIN-3248; the planned expansion of clinical trial sites for KN-8701; the expected timing of clinical data from KN-8701 and KN-4802; the potential benefits of the Kinnate Discovery Engine and progression of our pipeline; the financial condition of the company; and statements by our Chief Executive Officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are also intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends. Such expectations and projections may never materialize or may prove to be incorrect. These forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors, including risks related to recently transitioning to operating as a clinical-stage biopharmaceutical company with a limited operating history; the timing, progress and results of ongoing and planned preclinical studies and clinical trials for our current product candidates, our ability to raise additional capital to finance our operations; our ability to discover, advance through the preclinical and clinical development of, obtain regulatory approval for and commercialize our product candidates; the novel approach we are taking to discover and develop drugs; our ability to timely file and obtain approval of investigational new drug applications for our planned clinical trials; the potential for any clinical trial results to differ from our preclinical study results; negative impacts of the COVID-19 pandemic on our business, including ongoing and planned clinical trials and preclinical studies; competition in our industry; regulatory developments in the United States and other countries; our ability to attract, hire and retain highly skilled executive officers and employees; difficulties in managing our growth; our ability to protect our intellectual property; reliance on third parties to conduct our ongoing and planned preclinical studies and clinical trials, and to manufacture our product candidates; general economic and market conditions; and other risks. These and other risks, uncertainties, assumptions and other factors are further described under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022 that we have filed with the Securities and Exchange Commission (“SEC”), as well as in our subsequent filings we make with the SEC. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Investors should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Our forward-looking statements speak only as of the date of this release, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason in the future.

Investor & Media Contact:

Priyanka Shah | Priyanka.Shah@kinnate.com | +1-908-447-6134

Kinnate Biopharma Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and par value amounts)

(Unaudited)

	June 30, 2022			December 31, 2021
Assets
Current assets:
Cash and cash equivalents	$	35,065		$	116,096
Cash at consolidated joint venture		29,420			33,593
Short-term investments		197,930			103,362
Prepaid expenses and other current assets		4,718			5,639
Total current assets		267,133			258,690
Property and equipment, net		3,292			956
Right-of-use lease assets		3,781			-
Long-term investments		46,604			105,449
Restricted cash		371			371
Deferred offering costs		641			641
Other non-current assets		2,074			757
Total assets	$	323,896		$	366,864
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders' Equity
Current liabilities:
Accounts payable	$	2,016		$	3,148
Accrued expenses		8,612			9,239
Current portion of operating lease liabilities		836			-
Total current liabilities		11,464			12,387
Operating lease liabilities, long-term		3,703			-
Total liabilities		15,167			12,387
Redeemable convertible noncontrolling interests		35,000			35,000
Stockholders’ equity:
Preferred stock, $0.0001 par value; 200,000,000 shares authorized at June 30, 2022 and December 31, 2021; 0 shares outstanding at June 30, 2022 and December 31, 2021		-			-
Common stock, $0.0001 par value; 1,000,000,000 shares authorized at June 30, 2022 and December 31, 2021; 44,096,921 and 43,855,944 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively		4			4
Additional paid-in capital		473,525			463,089
Accumulated other comprehensive loss		(2,737	)		(524	)
Accumulated deficit		(197,063	)		(143,092	)
Total stockholders’ equity		273,729			319,477
Total liabilities, redeemable convertible noncontrolling interests and stockholders' equity	$	323,896		$	366,864

Kinnate Biopharma Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)

	Three Months Ended June 30,						Six Months Ended June 30,
	2022			2021			2022			2021
Operating expenses:
Research and development	$	19,767		$	16,242		$	39,414		$	28,908
General and administrative		7,639			5,327			15,051			10,142
Total operating expenses		27,406			21,569			54,465			39,050
Loss from operations		(27,406	)		(21,569	)		(54,465	)		(39,050	)
Other income, net		337			124			494			148
Net loss		(27,069	)		(21,445	)		(53,971	)		(38,902	)
Net loss attributable to redeemable convertible noncontrolling interests		-			-			-			-
Net loss attributable to Kinnate	$	(27,069	)	$	(21,445	)	$	(53,971	)	$	(38,902	)
Weighted-average shares outstanding, basic and diluted		44,002,391			43,535,887			43,942,986			43,506,825
Net loss per share, basic and diluted	$	(0.62	)	$	(0.49	)	$	(1.23	)	$	(0.89	)
Comprehensive loss:
Net loss	$	(27,069	)	$	(21,445	)	$	(53,971	)	$	(38,902	)
Other comprehensive loss:
Unrealized loss on investments		(557	)		(34	)		(2,213	)		(65	)
Total comprehensive loss		(27,626	)		(21,479	)		(56,184	)		(38,967	)
Comprehensive loss attributable to redeemable convertible noncontrolling interests		-			-			-			-
Comprehensive loss attributable to Kinnate	$	(27,626	)	$	(21,479	)	$	(56,184	)	$	(38,967	)

XML

Document and Entity Information	Aug. 11, 2022
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 11, 2022
Entity File Number	001-39743
Entity Registrant Name	KINNATE BIOPHARMA INC.
Entity Central Index Key	0001797768
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	82-4566526
Entity Address, Address Line One	103 Montgomery Street
Entity Address, Address Line Two	Suite 150
Entity Address, City or Town	San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94129
City Area Code	858
Local Phone Number	299-4699
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	KNTE
Security Exchange Name	NASDAQ