Kinnate Biopharma Inc. - Quarter Report: 2021 March (Form 10-Q)

Delaware		82-4566526
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)
12707 High Bluff Drive, Suite 200 San Diego, CA		92130
(Address of principal executive offices)		(Zip Code))

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

		Page
PART I—FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)	1
	Condensed Balance Sheets	1
	Condensed Statements of Operations and Comprehensive Loss	2
	Condensed Statements of Convertible Preferred Stock and Stockholders’ (Deficit) Equity	3
	Condensed Statements of Cash Flows	4
	Notes to Unaudited Condensed Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	26
PART II—OTHER INFORMATION
Item 1.	Legal Proceedings	28
Item 1A.	Risk Factors	28
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	105
Item 3.	Defaults Upon Senior Securities	105
Item 4.	Mine Safety Disclosures	105
Item 5.	Other Information	105
Item 6.	Exhibits	106
SIGNATURES		107

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the ability of our preclinical studies and planned clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;

•

the timing, progress and results of preclinical studies and planned clinical trials for our current product candidates and other product candidates we may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials will become available, and our research and development programs;

•

the timing, scope and likelihood of regulatory filings and approvals, including timing of INDs and final FDA approval of our current product candidates and any other future product candidates;

•

the timing, scope or likelihood of foreign regulatory filings and approvals;

•

our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies;

•

our manufacturing, commercialization, and marketing capabilities and strategy;

•

our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy;

•

the need to hire additional personnel and our ability to attract and retain such personnel;

•

the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;

•

our expectations regarding the approval and use of our product candidates in combination with other drugs;

•

our competitive position and the success of competing therapies that are or may become available;

•

our estimates of the number of patients that we will enroll in our clinical trials;

•

the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of our product candidates;

•

our ability to obtain and maintain regulatory approval of our product candidates;

•

our plans relating to the further development of our product candidates, including additional indications we may pursue;

•

existing regulations and regulatory developments in the United States, Europe and other jurisdictions;

•

our expectations regarding the impact of the COVID‑19 pandemic on our business;

•

our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our current product candidates and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;

•

our continued reliance on third parties to conduct additional preclinical studies and planned clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials;

•

our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;

•

the pricing and reimbursement of our current product candidates and other product candidates we may develop, if approved;

•

the rate and degree of market acceptance and clinical utility of our current product candidates and other product candidates we may develop;

•

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

•

our financial performance;

•

the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements;

•

the impact of laws and regulations;

•

our expectations regarding the period during which we will remain an emerging growth company under the JOBS Act; and

•

our anticipated use of our existing resources.

		March 31, 2021				December 31, 2020
Assets
Current assets:
Cash and cash equivalents		$	182,389			$	365,462
Short-term investments			65,808				31,398
Prepaid expenses and other current assets			2,975				3,343
Total current assets			251,172				400,203
Property and equipment, net			283				368
Long-term investments			134,910				-
Total assets		$	386,365			$	400,571
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	3,212			$	3,940
Accrued expenses			4,581				3,364
Total current liabilities			7,793				7,304
Commitments and contingencies (See Note 10)
Stockholders’ equity:
Preferred stock, $0.0001 par value; 200,000,000 shares authorized at March 31, 2021 and December 31, 2020; 0 shares outstanding at March 31, 2021 and December 31, 2020			-				-
Common stock, $0.0001 par value; 1,000,000,000 shares authorized at March 31, 2021 and December 31, 2020; 43,477,439 shares issued and outstanding at March 31, 2021 and December 31, 2020			4				4
Additional paid-in capital			449,394				446,601
Accumulated other comprehensive loss			(40	)			(9	)
Accumulated deficit			(70,786	)			(53,329	)
Total stockholders’ equity			378,572				393,267
Total liabilities and stockholders’ equity		$	386,365			$	400,571

		Three Months Ended March 31,
		2021				2020
Operating expenses:
Research and development		$	12,666			$	3,198
General and administrative (includes related party amounts of $0 and $92, respectively)			4,815				955
Total operating expenses			17,481				4,153
Loss from operations			(17,481	)			(4,153	)
Other income:
Interest income			403				212
Other (expense) income, net			(379	)			-
Total other income, net			24				212
Net loss			(17,457	)			(3,941	)
Unrealized loss on investments			(31	)			-
Comprehensive loss		$	(17,488	)		$	(3,941	)
Weighted-average shares outstanding, basic and diluted			43,477,439				3,672,446
Net loss per share, basic and diluted		$	(0.40	)		$	(1.07	)

		Series A Convertible Preferred Stock								Series B Convertible Preferred Stock								Common Stock								Additional Paid-in Capital				Accumulated Other Comprehensive Loss				Accumulated Deficit				Total Stockholders’ (Deficit) Equity
		Shares				Amount				Shares				Amount				Shares				Amount
Balance at December 31, 2019			7,762,727			$	18,942				9,705,182			$	74,204				3,665,020			$	-			$	82			$	-			$	(17,568	)		$	(17,486	)
Issuance costs for Series B convertible preferred stock			-				-				-				(16	)			-				-				-				-				-				-
Stock-based compensation expense			-				-				-				-				-				-				128				-				-				128
Exercise of stock options			-				-				-				-				7,593				-				3				-				-				3
Net loss			-				-				-				-				-				-				-				-				(3,941	)			(3,941	)
Balance at March 31, 2020			7,762,727			$	18,942				9,705,182			$	74,188				3,672,613			$	-			$	213			$	-			$	(21,509	)		$	(21,296	)
Balance at December 31, 2020			-			$	-				-			$	-				43,477,439			$	4			$	446,601			$	(9	)		$	(53,329	)		$	393,267
Stock-based compensation expense			-				-				-				-				-				-				2,793				-				-				2,793
Net loss			-				-				-				-				-				-				-				-				(17,457	)			(17,457	)
Other comprehensive loss			-				-				-				-				-				-				-				(31	)			-				(31	)
Balance at March 31, 2021			-			$	-				-			$	-				43,477,439			$	4			$	449,394			$	(40	)		$	(70,786	)		$	378,572

		Three Months Ended March 31,
		2021				2020
Cash flows from operating activities:
Net loss		$	(17,457	)		$	(3,941	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense			2,793				128
Depreciation			31				16
Amortization/accretion of investments			276				-
Loss on disposal of property and equipment			58				-
Changes in operating assets and liabilities:
Related party receivables, net			-				919
Prepaid expenses and other current assets			368				(156	)
Accounts payable and accrued expenses			489				360
Net cash used in operating activities			(13,442	)			(2,674	)
Cash flows from investing activities:
Purchases of short-term and long-term investments			(169,627	)			-
Purchases of property and equipment			(4	)			(29	)
Net cash used in investing activities			(169,631	)			(29	)
Cash flows from financing activities:
Issuance costs for Series B convertible preferred stock			-				(16	)
Proceeds upon stock option exercises			-				3
Net cash used in financing activities			-				(13	)
Net decrease in cash and cash equivalents			(183,073	)			(2,716	)
Cash and cash equivalents at the beginning of the period			365,462				76,453
Cash and cash equivalents at the end of the year		$	182,389			$	73,737

		Three Months Ended March 31,
		2021				2020
Numerator
Net loss		$	(17,457	)		$	(3,941	)
Denominator
Weighted-average shares outstanding used in computing net loss per share, basic and diluted			43,477,439				3,672,446
Net loss per share, basic and diluted		$	(0.40	)		$	(1.07	)

		Three Months Ended March 31,
		2021				2020
Options to purchase common stock			7,261,364				3,279,122
Convertible preferred stock			-				17,467,909
Total			7,261,364				20,747,031

		March 31, 2021				December 31, 2020
Furniture and fixtures		$	4			$	72
Computers and equipment			262				275
Computer software			104				104
Property and equipment			370				451
Less accumulated depreciation			(87	)			(83	)
Property and equipment, net		$	283			$	368

		March 31, 2021				December 31, 2020
Accrued research and development		$	3,306			$	1,580
Accrued compensation			896				1,388
Accrued legal fees			237				288
Other accruals			142				108
Total		$	4,581			$	3,364

		March 31, 2021
		Maturity in Years			Amortized Cost				Unrealized Gains				Unrealized Losses				Estimated Fair Value
Corporate debt securities		less than 1			$	35,741			$	7			$	(12	)		$	35,736
Commercial paper		less than 1				30,072				-				-				30,072
Short-term investments					$	65,813			$	7			$	(12	)		$	65,808
Corporate debt securities		1 - 2			$	20,706			$	-			$	(27	)		$	20,679
U.S. Treasury securities		1 - 2				91,321				11				(1	)			91,331
Asset-backed securities		1 - 2				22,915				-				(15	)			22,900
Long-term investments					$	134,942			$	11			$	(43	)		$	134,910

		December 31, 2020
		Maturity in Years			Amortized Cost				Unrealized Gains				Unrealized Losses				Estimated Fair Value
Corporate debt securities		less than 1			$	20,327			$	-			$	(9	)		$	20,318
Commercial paper		less than 1				11,080				-				-				11,080
Short-term investments					$	31,407			$	-			$	(9	)		$	31,398

		Fair Value Measurements at March 31, 2021
		Level 1				Level 2				Level 3				Total
Money market funds		$	181,388			$	-			$	-			$	181,388
Corporate debt securities			-				56,415				-				56,415
Commercial paper			-				30,072				-				30,072
U.S. Treasury securities			-				91,331				-				91,331
Asset-backed securities			-				22,900				-				22,900
Total cash equivalents and investments		$	181,388			$	200,718			$	-			$	382,106

		Fair Value Measurements at December 31, 2020
		Level 1				Level 2				Level 3				Total
Money market funds		$	364,461			$	-			$	-			$	364,461
Corporate debt securities			-				20,318				-				20,318
Commercial paper			-				11,080				-				11,080
Total cash equivalents and investments		$	364,461			$	31,398			$	-			$	395,859

		Options				Weighted- Average Exercise Price				Weighted- Average Remaining Contractual Term (in years)				Aggregate Intrinsic Value (in thousands)
Outstanding at January 1, 2021			6,265,409			$	4.12				9.3			$	223,454
Granted			1,044,050				35.33
Forfeited			(48,095	)			2.57
Exercised			-				-
Outstanding at March 31, 2021			7,261,364			$	8.61				9.1			$	168,071
Exercisable at March 31, 2021			1,146,727			$	3.05				8.5			$	32,321

		Three Months Ended March 31, 2021
Expected term (in years)			0.41
Expected volatility			50.70	%
Risk-free interest rate			0.09	%
Expected dividend			0	%

Item 2.

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

•

advance our RAF and FGFR programs from discovery and preclinical development into and through clinical development;

•

advance the development of our other small molecule research programs, including our CDK12 inhibitor;

•

expand our pipeline of product candidates through our own product discovery and development efforts;

•

seek to discover and develop additional product candidates;

•

seek regulatory approvals for any product candidates that successfully complete clinical trials;

•

establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs;

•

implement operational, financial and management systems;

•

attract, hire and retain additional clinical, scientific, management and administrative personnel;

•

maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how; and

•

operate as a public company.

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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;

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the cost of manufacturing compounds for use in our preclinical studies, including under agreements with third parties, such as consultants and contract manufacturing organizations (CMOs); and

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costs associated with consultants for chemistry, manufacturing and controls (CMC) development, regulatory, statistics and other services, including expenses for technology and facilities.

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employee-related expenses, including salaries and benefits, travel and stock-based compensation expense for employees engaged in research and development functions.

•

the timing and progress of preclinical and clinical development activities;

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

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our ability to maintain our current research and development programs and to establish new ones;

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establishing an appropriate safety profile with IND-enabling toxicology studies;

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successful patient enrollment in, and the initiation and completion of, clinical trials;

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per subject trial costs;

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the number of trials required for regulatory approval;

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the countries in which the trials are conducted;

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the length of time required to enroll eligible subjects and initial clinical trials;

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the number of subjects that participate in the trials;

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the drop-out and discontinuation rate of subjects;

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potential additional safety monitoring requested by regulatory authorities;

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the duration of subject participation in the trials and follow-up;

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the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to applicable regulatory authorities;

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the receipt of regulatory approvals from applicable regulatory authorities;

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the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities;

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the extent to which we establish collaborations, strategic partnerships or other strategic arrangements with third parties, if any, and the performance of any such third party;

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obtaining and retaining research and development personnel;

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establishing commercial manufacturing capabilities or making arrangements with CMOs;

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development and timely delivery of commercial-grade drug formulations that can be used in our planned clinical trials and for commercial launch; and

•

obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights.

		Three Months Ended March 31,
		2021				2020
		(in thousands)
Operating expenses:
Research and development (includes related party amounts of $0 and $92, respectively)		$	12,666			$	3,198
General and administrative			4,815				955
Total operating expenses			17,481				4,153
Loss from operations			(17,481	)			(4,153	)
Other income:
Interest income			403				212
Other (expense) income, net			(379	)			-
Total other income, net			24				212
Net loss		$	(17,457	)		$	(3,941	)

		Three Months Ended March 31,
		2021				2020
		(in thousands)
External expenses:
Lead programs		$	7,097			$	1,910
Other programs and other unallocated costs			2,012				531
Total external expenses			9,109				2,441
Internal expenses			3,557				757
Total research and development expenses		$	12,666			$	3,198

•

advance our RAF and FGFR programs from discovery and preclinical development into and through clinical development;

•

advance the development of our other small molecule research programs, including our CDK12 inhibitor;

•

expand our pipeline of product candidates through our own product discovery and development efforts;

•

seek to discover and develop additional product candidates;

•

seek regulatory approvals for any product candidates that successfully complete clinical trials;

•

establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs;

•

implement operational, financial and management systems;

•

attract, hire and retain additional clinical, scientific, management and administrative personnel;

•

maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how; and

•

operate as a public company.

•

the scope, timing, progress, results and costs of researching and developing our product candidates, and conducting preclinical studies and clinical trials;

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the scope, timing, progress, results and costs of researching and developing other product candidates that we may pursue;

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

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

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the costs of manufacturing commercial-grade products and sufficient inventory to support commercial launch;

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the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;

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the cost and timing of attracting, hiring and retaining skilled personnel to support our operations and continued growth;

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

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our ability to establish and maintain collaborations, strategic partnerships or marketing, distribution, licensing or other strategic arrangements with third parties on favorable terms, if at all;

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the extent to which we acquire or in-license other product candidates and technologies, if any;

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the timing, receipt and amount of sales of, or milestone payments related to or royalties on, our current or future product candidates, if any; and

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the costs associated with operating as a public company.

		Three Months Ended March 31,
		2021				2020
		(in thousands)
Net cash used in operating activities		$	(13,442	)		$	(2,674	)
Net cash used in investing activities			(169,631	)			(29	)
Net cash used in financing activities			-				(13	)
Net decrease in cash and cash equivalents		$	(183,073	)		$	(2,716	)

Item 3.

Quantitative and Qualitative Disclosures About Market Risk.

Item 4.

Controls and Procedures.

Item 1.

Legal Proceedings.

Item 1A.

Risk Factors.

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successful and timely completion of preclinical and clinical development of product candidates from our RAF and FGFR programs, our CDK12 and other research programs, and any other future programs;

•

establishing and maintaining relationships with contract research organizations (CROs) and clinical sites for the clinical development of product candidates from our RAF and FGFR programs, our CDK12 and other research programs, and any other future programs;

•

timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development;

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developing an efficient and scalable manufacturing process for our product candidates, including obtaining finished products that are appropriately packaged for sale;

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establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet the market demand for our product candidates, if approved;

•

successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators;

•

a continued acceptable safety profile following any marketing approval of our product candidates;

•

commercial acceptance of our product candidates by patients, the medical community and third-party payors;

•

satisfying any required post-marketing approval commitments to applicable regulatory authorities;

•

identifying, assessing and developing new product candidates;

•

obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

•

defending against third-party interference or infringement claims, if any;

•

entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;

•

obtaining coverage and adequate reimbursement by third-party payors for our product candidates;

•

addressing any competing therapies and technological and market developments; and

•

attracting, hiring and retaining qualified personnel.

•

successful and timely completion of preclinical studies;

•

approval of INDs for our planned clinical trials and future clinical trials;

•

addressing any potential delays resulting from factors related to the COVID‑19 pandemic;

•

successful initiation and completion of clinical trials;

•

successful and timely patient selection and enrollment in and completion of clinical trials;

•

maintaining and establishing relationships with CROs and clinical sites for the clinical development of our product candidates both in the United States and internationally;

•

the frequency and severity of adverse events in clinical trials;

•

demonstrating efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for marketing approval;

•

the timely receipt of marketing approvals from applicable regulatory authorities;

•

the timely identification, development and approval of companion diagnostic tests, if required;

•

the extent of any required post-marketing approval commitments to applicable regulatory authorities;

•

the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development and, if approved, commercialization of our product candidates;

•

obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

•

the protection of our rights in our intellectual property portfolio;

•

the successful launch of commercial sales following any marketing approval;

•

a continued acceptable safety profile following any marketing approval;

•

commercial acceptance by patients, the medical community and third-party payors; and

•

our ability to compete with other therapies.

•

failure of our product candidates in preclinical studies or clinical trials to demonstrate safety and efficacy;

•

receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials;

•

negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain research and/or drug development programs;

•

the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated or participants dropping out of these clinical trials at a higher rate than anticipated;

•

third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

•

the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable side effects or other unexpected characteristics or risks;

•

the cost of clinical trials of our product candidates being greater than anticipated;

•

the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate; and

•

regulators revising the requirements for approving our product candidates.

•

generating sufficient data to support the initiation or continuation of preclinical studies and clinical trials;

•

addressing any delays resulting from factors related to the COVID‑19 pandemic;

•

obtaining regulatory permission to initiate clinical trials;

•

contracting with the necessary parties to conduct clinical trials;

•

successful enrollment of patients in, and the completion of, clinical trials on a timely basis;

•

the timely manufacture of sufficient quantities of a product candidate for use in clinical trials; and

•

adverse events in clinical trials.

•

the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials;

•

the FDA, EMA or other comparable foreign regulatory authorities may determine that we have not demonstrated the safety and efficacy of our product candidates, or that they undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;

•

the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval;

•

the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

•

we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;

•

the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

•

the FDA, EMA or other comparable regulatory authorities may fail to approve companion diagnostic tests required for our product candidates; and

•

the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

•

size and nature of the patient population;

•

severity of the disease under investigation;

•

availability and efficacy of approved drugs for the disease under investigation;

•

patient eligibility criteria for the trial in question as defined in the protocol, including biomarker-driven identification and/or certain highly-specific criteria related to stage of disease progression, which may limit the patient populations eligible for our clinical trials to a greater extent than competing clinical trials for the same indication that do not have biomarker-driven patient eligibility criteria;

•

perceived risks and benefits of the product candidate under study;

•

clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved or other product candidates being investigated for the indications we are investigating;

•

clinicians’ willingness to screen their patients for biomarkers to indicate which patients may be eligible for enrollment in our clinical trials;

•

patient referral practices of physicians;

•

the ability to monitor patients adequately during and after treatment;

•

proximity and availability of clinical trial sites for prospective patients; and

•

the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may be late-stage cancer patients, will not survive the full terms of the clinical trials.

•

delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

•

delays or difficulties in enrolling and retaining patients in any clinical trials, particularly elderly subjects, who are at a higher risk of severe illness or death from COVID‑19;

•

difficulties interpreting data from our clinical trials due to the possible effects of COVID‑19 on patients;

•

diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of clinical trials;

•

interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others;

•

interruption or delays in the operations of the FDA, EMA or other regulatory authorities, which may impact review and approval timelines;

•

limitations in resources that would otherwise be focused on the conduct of our business, our preclinical studies or our clinical trials, including because of sickness or the desire to avoid contact with large groups of people or as a result of government-imposed “shelter in place” or similar working restrictions;

•

interruptions, difficulties or delays arising in our existing operations and company culture as a result of all of our employees working remotely, including those hired during the COVID‑19 pandemic;

•

delays in receiving approval from regulatory authorities to initiate our clinical trials;

•

delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials; interruptions in preclinical studies due to restricted or limited operations at the CROs conducting such studies;

•

interruption in global freight and shipping that may affect the transport of clinical trial materials, such as investigational drug product to be used in our clinical trials;

•

changes in regulations as part of a response to the COVID‑19 pandemic which may require us to change the ways in which our clinical trials are to be conducted, or to discontinue the clinical trials altogether, or which may result in unexpected costs;

•

delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government or contractor personnel; and

•

refusal of the FDA, EMA or other regulatory authorities to accept data from clinical trials in affected geographies outside of their respective jurisdictions.

•

the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments;

•

the timing of market introduction of the product candidate as well as competitive products;

•

the clinical indications for which a product candidate is approved;

•

restrictions on the use of product candidates in the labeling approved by regulatory authorities, such as boxed warnings or contraindications in labeling, or a risk evaluation and mitigation strategy, if any, which may not be required of alternative treatments and competitor products;

•

the potential and perceived advantages of our product candidates over alternative treatments;

•

the cost of treatment in relation to alternative treatments;

•

the availability of coverage and adequate reimbursement by third-party payors, including government authorities;

•

the availability of an approved product candidate for use as a combination therapy;

•

relative convenience and ease of administration;

•

the willingness of the target patient population to try new therapies and undergo required diagnostic screening to determine treatment eligibility and of physicians to prescribe these therapies and diagnostic tests;

•

the effectiveness of sales and marketing efforts;

•

unfavorable publicity relating to our product candidates; and

•

the approval of other new therapies for the same indications.

•

the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials;

•

the FDA, EMA or other comparable foreign regulatory authorities may determine that we have not demonstrated the safety and efficacy of our product candidates, or that they have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;

•

the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval;

•

the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials;

•

we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that our product candidate’s risk-benefit ratio for its proposed indication is acceptable;

•

the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and

•

the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

•

delays in or the rejection of product approvals;

•

restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;

•

restrictions on the products, manufacturers or manufacturing process;

•

warning or untitled letters;

•

civil and criminal penalties;

•

injunctions;

•

suspension or withdrawal of regulatory approvals;

•

product seizures, detentions or import bans;

•

voluntary or mandatory product recalls and publicity requirements;

•

total or partial suspension of production;

•

imposition of restrictions on operations, including costly new manufacturing requirements;

•

revisions to the labeling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings;

•

imposition of a REMS, which may include distribution or use restrictions; and

•

requirements to conduct additional post-market clinical trials to assess the safety of the product.

•

the demand for our product candidates, if we obtain regulatory approval;

•

our ability to set a price that we believe is fair for our products;

•

our ability to obtain coverage and reimbursement approval for a product;

•

our ability to generate revenue and achieve or maintain profitability;

•

the level of taxes that we are required to pay; and

•

the availability of capital.

•

the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Violations are subject to civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act (FCA). There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection;

•

federal civil and criminal false claims laws, including the FCA, which can be enforced through civil “qui tam” or “whistleblower” actions, and civil monetary penalty laws, impose criminal and civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other federal health care programs that are false or fraudulent; knowingly making or causing a false statement material to a false or fraudulent claim or an obligation to pay money to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing such an obligation. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The FCA also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. When an entity is determined to have violated the federal civil FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

•

HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it;

•

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses and their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information as well as their covered subcontractors, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions;

•

the federal Physician Payments Sunshine Act, created under the ACA and its implementing regulations, which require applicable manufacturers of covered drugs, devices, biologicals or medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to HHS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Effective January 1, 2022, these reporting obligations with respect to covered recipients will extend to include payments and transfers of value made during the previous year to certain non-physician providers, such as physician assistants and nurse practitioners, among others; and

•

analogous state and foreign laws and regulations, such as state and foreign anti-kickback, false claims, consumer protection and unfair competition laws which may apply to pharmaceutical business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and reporting of gifts, compensations and other remuneration and items of value provided to healthcare professionals and entities; state and local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

•

identifying, recruiting, integrating, maintaining, retaining and motivating our current and additional employees;

•

managing our internal development efforts effectively, including the preclinical, clinical, FDA, EMA and other comparable foreign regulatory authorities’ review process for our RAF and FGFR programs and our other product candidates, while complying with any contractual obligations to contractors and other third parties;

•

managing increasing operational and managerial complexity; and

•

improving our operational, financial and management controls, reporting systems and procedures.

•

differing regulatory requirements and reimbursement regimes in foreign countries, such as the lack of pathways for accelerated drug approval, may result in foreign regulatory approvals taking longer and being more costly than obtaining approval in the United States;

•

foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials or our interpretation of data from nonclinical studies or clinical trials;

•

approval policies or regulations of foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval;

•

impact of the COVID‑19 pandemic on our ability to produce our product candidates and conduct clinical trials in foreign countries;

•

unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;

•

economic weakness, including inflation, or political instability in particular foreign economies and markets;

•

compliance with legal requirements applicable to privacy, data protection, information security and other matters;

•

compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

•

foreign taxes, including withholding of payroll taxes;

•

foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;

•

difficulties staffing and managing foreign operations;

•

complexities associated with managing multiple payor reimbursement regimes and government payors in foreign countries;

•

workforce uncertainty in countries where labor unrest is more common than in the United States;

•

potential liability under the FCPA or comparable foreign regulations;

•

challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;

•

production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

•

business interruptions resulting from geo-political actions, including war and terrorism, trade policies, treaties and tariffs.

•

the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction;

•

patent applications may not result in any patents being issued;

•

patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;

•

our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use and sell our potential product candidates;

•

there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and

•

countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates.

•

others may be able to develop products that are similar to our product candidates but that are not covered by the claims of the patents that we own or license;

•

we or our future licensors or collaborators might not have been the first to make the inventions covered by the issued patents or patent application that we own or license;

•

we or our future licensors or collaborators might not have been the first to file patent applications covering certain of our inventions;

•

others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

•

it is possible that the pending patent applications we own or license will not lead to issued patents;

•

issued patents that we own or license may be held invalid or unenforceable, as a result of legal challenges by our competitors;

•

our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

•

we may not develop additional proprietary technologies that are patentable;

•

the patents of others may have an adverse effect on our business; and

•

we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

•

result in costly litigation that may cause negative publicity;

•

divert the time and attention of our technical personnel and management;

•

cause development delays;

•

prevent us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law;

•

require us to develop non-infringing technology, which may not be possible on a cost-effective basis;

•

subject us to significant liability to third parties; or

•

require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in our competitors gaining access to the same technology.

•

the scope of rights granted under the license agreement and other interpretation-related issues;

•

whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

•

our right to sublicense patents and other rights to third parties;

•

our diligence obligations under the license agreement and what activities satisfy those diligence obligations;

•

our right to transfer or assign the license;

•

the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our future licensors and us and our partners; and

•

the priority of invention of patented technology.

•

the failure of the third party to manufacture our product candidates according to our schedule and specifications, or at all, including if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them;

•

the reduction or termination of production or deliveries by suppliers, or the raising or prices or renegotiation of terms;

•

the termination or nonrenewal of arrangements or agreements by our third-party contractors at a time that is costly or inconvenient for us;

•

the breach by the third-party contractors of our agreements with them;

•

the failure of third-party contractors to comply with applicable regulatory requirements, including cGMPs;

•

the breach by the third-party contractors of our agreements with them;

•

the failure of the third party to manufacture our product candidates according to our specifications;

•

the mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified;

•

clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales; and

•

the misappropriation of our proprietary information, including our trade secrets and know-how.

•

increased operating expenses and cash requirements;

•

the assumption of additional indebtedness or contingent liabilities;

•

the issuance of our equity securities;

•

assimilation of operations, intellectual property, products and product candidates of an acquired company, including difficulties associated with integrating new personnel;

•

the diversion of our management’s attention from our existing programs and initiatives in pursuing such a strategic merger or acquisition;

•

retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;

•

risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products, product candidates and marketing approvals; and

•

our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

•

collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected;

•

collaborators may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, including as a result of a business combination or sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities;

•

collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

•

collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely

•

to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

•

a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products;

•

we may grant exclusive rights to our collaborators that would prevent us from collaborating with others;

•

collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property related proceedings;

•

disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management attention and resources;

•

collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates;

•

collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all;

•

collaborators may not provide us with timely and accurate information regarding development progress and activities under the collaboration or may limit our ability to share such information, which could adversely impact our ability to report progress to our investors and otherwise plan our own development of our product candidates;

•

collaborators may own or co-own intellectual property covering our products or product candidates that result from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; and

•

a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.

•

the timing and results of INDs, preclinical studies and clinical trials of our product candidates or those of our competitors;

•

the success of competitive products or announcements by potential competitors of their product development efforts;

•

regulatory actions with respect to our products or product candidates or our competitors’ products or product candidates;

•

actual or anticipated changes in our growth rate relative to our competitors;

•

regulatory or legal developments in the United States and other countries, including changes in leadership at various federal departments and agencies as well as new legislation, executive, and administrative actions under the Biden administration;

•

developments or disputes concerning patent applications, issued patents or other proprietary rights;

•

the recruitment or departure of key personnel;

•

announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments;

•

actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

•

fluctuations in the valuation of companies perceived by investors to be comparable to us;

•

market conditions in the pharmaceutical and biotechnology sector;

•

changes in the structure of healthcare payment systems;

•

share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;

•

announcement or expectation of additional financing efforts;

•

sales of our common stock by us, our insiders or our other stockholders;

•

expiration of market stand-off or lock-up agreements;

•

the impact of any natural disasters or public health emergencies, such as the COVID‑19 pandemic; and

•

general economic, political, industry and market conditions.

•

the timing and cost of, and level of investment in, research and development activities relating to our programs, which will change from time to time;

•

our ability to enroll patients in clinical trials and the timing of enrollment;

•

the cost of manufacturing our current product candidates and any future product candidates, which may vary depending on FDA, EMA or other comparable foreign regulatory authority guidelines and requirements, the quantity of production and the terms of our agreements with manufacturers;

•

expenditures that we will or may incur to acquire or develop additional product candidates and technologies or other assets;

•

the timing and outcomes of preclinical studies and clinical trials for product candidates from our RAF and FGFR programs, and any product candidates from our research programs, or competing product candidates;

•

the need to conduct unanticipated clinical trials or trials that are larger or more complex than anticipated;

•

competition from existing and potential future products that compete with our RAF or FGFR programs or any of our research programs, and changes in the competitive landscape of our industry, including consolidation among our competitors or partners;

•

any delays in regulatory review or approval of product candidates from our RAF or FGFR programs, or any of our research programs;

•

the level of demand for any of our product candidates, if approved, which may fluctuate significantly and be difficult to predict;

•

the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future products that compete with our RAF or FGFR programs, or any of our research programs;

•

our ability to commercialize product candidates from our RAF or FGFR programs, or any of our research programs, if approved, inside and outside of the United States, either independently or working with third parties;

•

our ability to establish and maintain collaborations, licensing or other arrangements;

•

our ability to adequately support future growth;

•

potential unforeseen business disruptions that increase our costs or expenses;

•

future accounting pronouncements or changes in our accounting policies; and

•

the changing and volatile global economic and political environment.

•

being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in our periodic reports;

•

not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (Sarbanes-Oxley Act);

•

not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;

•

reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and

•

exemptions from the requirements of holding nonbinding advisory stockholder votes on executive compensation and stockholder approval of any golden parachute payments not previously approved.

•

establish a classified board of directors so that not all members of our board are elected at one time;

•

permit only the board of directors to establish the number of directors and fill vacancies on the board;

•

provide that directors may only be removed “for cause” and only with the approval of two-thirds of our stockholders;

•

authorize the issuance of “blank check” preferred stock that our board could use to implement a stockholder rights plan (also known as a “poison pill”);

•

eliminate the ability of our stockholders to call special meetings of stockholders;

•

prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders;

•

prohibit cumulative voting;

•

authorize our board of directors to amend the bylaws;

•

establish advance notice requirements for nominations for election to our board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and

•

require a super-majority vote of stockholders to amend some provisions described above.

•

any derivative action or proceeding brought on our behalf;

•

any action asserting a claim of breach of fiduciary duty;

•

any action asserting a claim against us arising under the DGCL, our amended- and restated certificate of incorporation or our amended and restated bylaws; and

•

any action asserting a claim against us that is governed by the internal-affairs doctrine.

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

Item 3.

Defaults Upon Senior Securities.

Item 4.

Mine Safety Disclosures.

Item 5.

Other Information.

Item 6.

Exhibits.

				Incorporated by Reference
Exhibit Number		Exhibit Description		Form		File No.		Exhibit		Filing Date
31.1		Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2		Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1†		Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2†		Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

†

The certifications attached as Exhibit 32.1 and Exhibit 32.2 that accompany this Quarterly Report on Form 10‑Q are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10‑Q, irrespective of any general incorporation language contained in such filing.

	KINNATE BIOPHARMA INC.
May 17, 2021	By:	/s/ Nima Farzan
		Nima Farzan
		Chief Executive Officer and President (Principal Executive Officer)
May 17, 2021	By:	/s/ Mark Meltz
		Mark Meltz
		Chief Operating Officer and General Counsel (Principal Executive Officer)