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, 2020

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: 001-38682

KODIAK SCIENCES INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	27-0476525
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
1200 Page Mill Road Palo Alto, CA	94304
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (650) 281-0850

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	KOD	The Nasdaq Stock Market LLC

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

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

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

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

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

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

As of October 31, 2020, the registrant had 44,803,447 shares of common stock, $0.0001 par value per share, outstanding.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or Exchange Act. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time those statements are made and/or management’s good faith beliefs as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements.

Forward-looking statements include all statements that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, or similar expressions and comparable terminology intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties, including those set forth under the section of this Quarterly Report on Form 10-Q titled “Part II, Item 1A — Risk Factors” and elsewhere in this report. Forward-looking statements include, but are not limited to, statements about:

• the success, cost and timing of our development activities, preclinical studies, clinical trials and regulatory filings;

• the translation of our preclinical results and data and early clinical trial results in particular relating to safety, efficacy and durability into future clinical trials in humans;

• the continued durability, efficacy and safety of our product candidates;

• our ability to achieve our “2022 Vision” of a Biologics License Application, or BLA, of KSI-301 in 2022;

• the number, size and design of clinical trials that regulatory authorities may require to obtain marketing approval, including the order and number of clinical studies required to support a BLA in wet age-related macular degeneration, or wet AMD, diabetic macular edema, or DME, retinal vein occlusion, or RVO, and diabetic retinopathy, or DR;

• the timing or likelihood of regulatory filings and approvals, including the potential to achieve the U.S. Food and Drug Administration, or FDA, approval of KSI-301 in wet AMD, DME, RVO and DR;

• our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of any approved product candidate;

• our ability to obtain funding for our operations, including funding necessary to develop, manufacture and commercialize our product candidates;

• the rate and degree of market acceptance of our product candidates;

• the success of competing products or platform technologies that are or may become available;

• our plans and ability to establish sales, marketing and distribution infrastructure to commercialize any product candidates for which we obtain approval;

• our expectation as to the concentration of retinal specialists in the United States and its impact on our sales and marketing plans;

• our expectations regarding our ability to enter into manufacturing-related commitments, and the timing thereof;

• future agreements with third parties in connection with the commercialization of our product candidates;

• the size and growth potential of the markets for our product candidates, if approved for commercial use, and our ability to serve those markets;

• existing regulations and regulatory developments in the United States and foreign countries;

• the expected potential benefits of strategic collaboration agreements and our ability to attract collaborators with development, regulatory and commercialization expertise;

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• the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

• potential claims relating to our intellectual property and third-party intellectual property;

• our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

• the pricing and reimbursement of our product candidates, if approved;

• our estimates regarding the impact of the ongoing COVID-19 pandemic on our business and operations, the business and operations of our collaborators, and on the global economy;

• our ability to attract and retain key managerial, scientific and medical personnel;

• the accuracy of our estimates regarding the sufficiency of our cash resources, expenses, future revenue, capital requirements and needs for additional financing;

• our financial performance; and

• our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act.

All forward-looking statements are based on information available to us on the date of this Quarterly Report on Form 10-Q and we will not update any of the forward-looking statements after the date of this Quarterly Report on Form 10-Q, except as required by law. Our actual results could differ materially from those discussed in this Quarterly Report on Form 10-Q. The forward-looking statements contained in this Quarterly Report on Form 10-Q, and other written and oral forward-looking statements made by us from time to time, are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, and you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Factors that might cause such a difference include, but are not limited to, those discussed in the following discussion and within the section of this Quarterly Report on Form 10-Q titled “Part II, Item 1A — Risk Factors”.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and although we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted a thorough inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

All brand names or trademarks appearing in this report are the property of their respective holders. Unless the context requires otherwise, references in this report to “Kodiak” the “Company,” “we,” “us,” and “our” refer to Kodiak Sciences Inc.

ii

SELECTED RISKS AFFECTING OUR BUSINESS

Investing in our common stock involves numerous risks, including the risks described in “Part II—Other Information, Item 1A. Risk Factors” of this Quarterly Report on Form 10-Q, any one of which could materially adversely affect our business, financial condition, results of operations, and prospects. These risks include, among others, the following:

• We are in the clinical stage of drug development and have a very limited operating history and no products approved for commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability.

• We have incurred significant net losses in each period since our inception and anticipate that we will continue to incur significant and increasing net losses for the foreseeable future.

• Drug development is a highly uncertain undertaking and involves a substantial degree of risk. We have never generated any revenue from product sales, and we may never generate revenue or be profitable.

• If we fail to obtain additional financing, we may be unable to complete the development and, if approved, commercialization of our product candidates.

• Our prospects are heavily dependent on our KSI-301 product candidate, which is currently in clinical development for multiple indications.

• A failure of KSI-301 in clinical development may require us to discontinue development of other product candidates based on our ABC Platform.

• Research and development of biopharmaceutical products is inherently risky. We cannot give any assurance that any of our product candidates will receive regulatory, including marketing, approval, which is necessary before they can be commercialized.

• We may encounter substantial delays in our clinical trials, or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all.

• We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may retain their market share with existing drugs, or achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours, which may negatively impact our ability to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition.

• The manufacture of our product candidates is highly complex and requires substantial lead time to produce.

• We expect to rely on third parties to conduct our clinical trials and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.

• We contract with third parties for the manufacture of materials for our product candidates and preclinical studies and clinical trials and for commercialization of any product candidates that we may develop. This reliance on third parties carries and may increase the risk that we will not have sufficient quantities of such materials, product candidates or any medicines that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

• If we are unable to obtain and maintain patent protection for any product candidates we develop or for our ABC Platform, our competitors could develop and commercialize products or technology similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop, and our technology may be adversely affected.

• Third-party claims of intellectual property infringement, misappropriation or other violation against us or our collaborators may prevent or delay the development and commercialization of our ABC Platform, product candidates and other technologies.

• Our business is currently affected and could be materially and adversely affected in the future by the effects of disease outbreaks, epidemics and pandemics, including the ongoing effects of the COVID-19 pandemic. The COVID-19 pandemic continues to impact our business and could materially and adversely affect our operations, as well as the business or operations of our manufacturers, CROs or other third parties with whom we conduct business.

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Table of Contents

		Page
PART I.	FINANCIAL INFORMATION	1
Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss	2
	Condensed Consolidated Statements of Stockholders’ Equity	3
	Condensed Consolidated Statements of Cash Flows	4
	Notes to Unaudited Condensed Consolidated Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	13
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	47
Item 4.	Controls and Procedures	47
PART II.	OTHER INFORMATION	48
Item 1.	Legal Proceedings	48
Item 1A.	Risk Factors	48
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	87
Item 3.	Defaults Upon Senior Securities	87
Item 4.	Mine Safety Disclosures	87
Item 5.	Other Information	87
Item 6.	Exhibits	88
Signatures		89

iv

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited).

Kodiak Sciences Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(Unaudited)

	September 30, 2020			December 31, 2019
Assets
Current assets:
Cash and cash equivalents	$	291,585		$	211,797
Marketable securities		88,865			124,684
Prepaid expenses and other current assets		1,295			2,749
Total current assets		381,745			339,230
Marketable securities		—			11,696
Restricted cash		11,015			140
Property and equipment, net		3,568			996
Operating lease right-of-use asset		75,542			1,790
Other assets		8,866			5,014
Total assets	$	480,736		$	358,866
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	5,269		$	2,619
Accrued and other current liabilities		16,219			8,658
Operating lease liability		1,017			434
Total current liabilities		22,505			11,711
Operating lease liability, net of current portion		76,307			1,501
Liability related to sale of future royalties		99,877			—
Other liabilities		267			295
Total liabilities		198,956			13,507
Commitments and contingencies (Note 6)
Stockholders’ equity:
Preferred stock, $0.0001 par value, 10,000,000 shares authorized;    0 shares issued and outstanding at September 30, 2020 and    December 31, 2019		—			—
Common stock, $0.0001 par value, 490,000,000 shares authorized at    September 30, 2020 and December 31, 2019; 44,760,513 and    44,413,404 shares issued and outstanding at September 30, 2020    and December 31, 2019, respectively		5			5
Additional paid-in capital		526,174			503,475
Accumulated other comprehensive income		245			10
Accumulated deficit		(244,644	)		(158,131	)
Total stockholders’ equity		281,780			345,359
Total liabilities and stockholders’ equity	$	480,736		$	358,866

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

1

Kodiak Sciences Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Operating expenses
Research and development	$	29,306		$	10,115		$	70,033		$	24,676
General and administrative		7,357			2,617			19,132			8,330
Total operating expenses		36,663			12,732			89,165			33,006
Loss from operations		(36,663	)		(12,732	)		(89,165	)		(33,006	)
Interest income		645			277			2,551			1,070
Interest expense		(6	)		(2	)		(19	)		(8	)
Other income (expense), net		(98	)		77			120			195
Net loss	$	(36,122	)	$	(12,380	)	$	(86,513	)	$	(31,749	)
Net loss per common share, basic and diluted	$	(0.80	)	$	(0.33	)	$	(1.92	)	$	(0.85	)
Weighted-average common shares outstanding used in    computing net loss per common share, basic and diluted		45,119,885			37,330,066			44,972,085			37,291,328
Other comprehensive income (loss)
Change in unrealized gains related to available-for-sale    debt securities, net of tax		(349	)		7			235			19
Total other comprehensive income (loss)		(349	)		7			235			19
Comprehensive loss	$	(36,471	)	$	(12,373	)	$	(86,278	)	$	(31,730	)

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

2

Kodiak Sciences Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except share and per share amounts)

(Unaudited)

	Common Stock				Additional Paid-In			Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Capital			Income (Loss)			Deficit			Equity
Balances at December 31, 2019		44,413,404	$	5	$	503,475		$	10		$	(158,131	)	$	345,359
Issuance of common stock upon    exercise of stock options		39,297		—		159			—			—			159
Stock-based compensation    expense		—		—		6,082			—			—			6,082
Other comprehensive income		—		—		—			479			—			479
Net loss		—		—		—			—			(24,392	)		(24,392	)
Balances at March 31, 2020		44,452,701		5		509,716			489			(182,523	)		327,687
Issuance of common stock upon    exercise of stock options		203,373		—		720			—			—			720
Issuance of common stock upon    vesting of restricted stock units,    net of taxes withheld		10,942		—		(206	)		—			—			(206	)
Stock-based compensation    expense		—		—		6,890			—			—			6,890
Other comprehensive income		—		—		—			105			—			105
Net loss		—		—		—			—			(25,999	)		(25,999	)
Balances at June 30, 2020		44,667,016		5		517,120			594			(208,522	)		309,197
Issuance of common stock upon    exercise of stock options		93,497		—		813			—			—			813
Stock-based compensation    expense		—		—		8,241			—			—			8,241
Other comprehensive loss		—		—		—			(349	)		—			(349	)
Net loss		—		—		—			—			(36,122	)		(36,122	)
Balances at September 30, 2020		44,760,513		5		526,174			245			(244,644	)		281,780
	Common Stock				Additional Paid-In			Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Capital			Income (Loss)			Deficit			Equity
Balances at December 31, 2018		36,829,857	$	4	$	197,595		$	—		$	(110,766	)	$	86,833
Issuance of common stock upon    exercise of stock options		80,000		—		83			—			—			83
Stock-based compensation    expense		—		—		1,157			—			—			1,157
Other comprehensive income		—		—		—			6			—			6
Net loss		—		—		—			—			(7,984	)		(7,984	)
Balances at March 31, 2019		36,909,857		4		198,835			6			(118,750	)		80,095
Issuance of common stock upon    exercise of stock options		21,284		—		59			—			—			59
Stock-based compensation    expense		—		—		1,244			—			—			1,244
Other comprehensive income		—		—		—			6			—			6
Net loss		—		—		—			—			(11,385	)		(11,385	)
Balances at June 30, 2019		36,931,141		4		200,138			12			(130,135	)		70,019
Issuance of common stock upon    exercise of stock options		77,855		—		272			—			—			272
Issuance of common stock upon    exercise of common stock warrant		1		—		—			—			—			—
Stock-based compensation    expense		—		—		1,773			—			—			1,773
Other comprehensive income		—		—		—			7			—			7
Net loss		—		—		—			—			(12,380	)		(12,380	)
Balances at September 30, 2019		37,008,997		4		202,183			19			(142,515	)		59,691

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

3

Kodiak Sciences Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

	Nine Months Ended September 30,
	2020			2019
Cash flows from operating activities
Net loss	$	(86,513	)	$	(31,749	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		317			405
Stock-based compensation		21,213			4,174
Amortization (accretion) of premium (discount) on marketable securities		(145	)		(195	)
Amortization of operating lease right-of-use asset		1,793			276
Amortization of issuance costs		36			—
Changes in assets and liabilities:
Prepaid expenses and other current assets		1,518			1,782
Other assets		(3,654	)		(4,365	)
Accounts payable		1,616			620
Accrued and other current liabilities		7,566			1,480
Operating lease liability		(156	)		(281	)
Net cash used in operating activities		(56,409	)		(27,853	)
Cash flows from investing activities
Purchase of property and equipment		(1,855	)		(284	)
Purchase of marketable securities		(86,317	)		(40,231	)
Maturities of marketable securities		134,148			16,800
Net cash provided by (used in) investing activities		45,976			(23,715	)
Cash flows from financing activities
Proceeds from issuance of common stock upon options exercise		1,692			414
Payments for restricted stock units, net of taxes withheld		(206	)		—
Proceeds from sale of future royalties, net of issuance costs		99,643			—
Principal payments of capital lease		(5	)		(41	)
Principal payments of tenant improvement allowance payable		(28	)		(26	)
Net cash provided by financing activities		101,096			347
Net increase (decrease) in cash, cash equivalents and restricted cash		90,663			(51,221	)
Cash, cash equivalents and restricted cash, at beginning of period		211,937			88,394
Cash, cash equivalents and restricted cash, at end of period	$	302,600		$	37,173
Reconciliation of cash, cash equivalents and restricted cash to consolidated balance sheets
Cash and cash equivalents	$	291,585		$	37,033
Restricted cash		11,015			140
Cash, cash equivalents and restricted cash in consolidated balance sheets	$	302,600		$	37,173
Supplemental disclosures of non-cash investing and financing information: