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 March 31, 2021
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: 001-39460
KYMERA THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware |
81-2992166 |
(State or other jurisdiction of incorporation or organization |
(I.R.S. Employer |
|
|
200 Arsenal Yards Blvd., Suite 230 Watertown, Massachusetts |
02472 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (857) 285-5300
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, par value $0.0001 per share |
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KYMR |
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The Nasdaq Global Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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☐ |
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Accelerated filer |
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☐ |
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|||
Non-accelerated filer |
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☒ |
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Smaller reporting company |
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☒ |
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Emerging growth company |
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☒ |
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 April 30, 2021, the registrant had 45,030,094 shares of common stock, $0.0001 par value per share, outstanding.
Summary of the Material and Other Risks Associated with Our Business
|
• |
We are a biopharmaceutical company with a limited operating history and have not generated any revenue to date from drug sales, and may never become profitable. |
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• |
We have incurred significant operating losses in recent periods and anticipate that we will incur continued losses for the foreseeable future. |
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• |
We will need to raise substantial additional funding. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our product candidate development programs or future commercialization efforts. |
|
• |
We are very early in our development efforts and our IRAK4, IRAKIMiD, and STAT3 programs are still in preclinical or early clinical development. If we are unable to advance them into and through the clinic for safety or efficacy reasons or commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed. |
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• |
Our approach to the discovery and development of product candidates based on our Pegasus platform is novel and unproven, which makes it difficult to predict the time, cost of development, and likelihood of successfully developing any products. |
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• |
Business interruptions resulting from the coronavirus disease (COVID-19) outbreak or similar public health crises could cause a disruption of the development of our product candidates and adversely impact our business. |
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• |
We may not be successful in our efforts to identify or discover additional product candidates or we may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success. |
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• |
If we experience delays or difficulties in the initiation or enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented. |
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• |
Our current or future product candidates may cause adverse or other undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any. |
|
• |
Even if we receive regulatory approval for any of our current or future product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. |
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• |
We rely, and expect to continue to rely, on third parties to conduct our ongoing and planned clinical trials for our current and future product candidates. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our current and potential future product candidates and our business could be substantially harmed. |
|
• |
If we are unable to obtain and maintain patent and other intellectual property protection for our technology and product candidates or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and drugs may be impaired. |
i
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “intends”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, “continue” or the negative of these terms or other comparable terminology. These statements are not guarantees of future results or performance and involve substantial risks and uncertainties. Forward-looking statements in this Quarterly Report include, but are not limited to, express or implied statements about:
|
• |
the initiation, timing, progress, results, and cost of our research and development programs, and our current and future preclinical and future clinical studies, 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 trials will become available, and our research and development programs; |
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• |
our ability to continue to construct Pegasus, our drug discovery platform, and to enable a rational and effective drug discovery and development engine; |
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• |
the timing and the success of preclinical and clinical studies under our IRAK4, IRAKIMiD, and STAT3 programs; |
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• |
our plans to submit investigational new drug applications to the FDA for current and future product candidates; |
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• |
the subsequent initiation of planned clinical trials; |
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• |
our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop product candidates, including by applying learnings from one program to other programs and from one modality to our other modalities; |
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our potential ability to manufacture our drug substances, delivery vehicles, and product candidates for preclinical use, for clinical trials and on a larger scale for commercial use, if approved; |
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• |
the ability and willingness of our third-party strategic collaborators to continue research and development activities relating to our development candidates and product candidates; |
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• |
our ability to obtain funding for our operations necessary to complete further development and commercialization of our product candidates; |
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• |
our ability to obtain and maintain regulatory approval of our product candidates; |
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• |
our ability to commercialize our products, if approved; |
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• |
the pricing and reimbursement of our product candidates, if approved; |
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• |
the implementation of our business model, and strategic plans for our business, product candidates, and technology; |
|
• |
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; |
|
• |
estimates of our future expenses, revenues, capital requirements, and our needs for additional financing; |
|
• |
the potential benefits of strategic collaboration agreements, our ability to enter into strategic collaborations or arrangements, and our ability to attract collaborators with development, regulatory and commercialization expertise; |
|
• |
future agreements with third parties in connection with the commercialization of product candidates and any other approved product; |
|
• |
the size and growth potential of the markets for our product candidates, and our ability to serve those markets; |
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• |
our financial performance; |
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• |
the rate and degree of market acceptance of our product candidates; |
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• |
regulatory developments in the United States and foreign countries; |
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• |
our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; |
|
• |
our ability to produce our products or product candidates with advantages in turnaround times or manufacturing cost; |
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• |
the success of competing therapies that are or may become available; |
|
• |
our ability to attract and retain key scientific or management personnel; |
ii
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• |
the impact of laws and regulations; |
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• |
developments relating to our competitors and our industry; |
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• |
the effect of the COVID-19 pandemic, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business operations, including but not limited to our preclinical studies and future clinical trials; |
|
• |
our expectations regarding the time during which we will continue to be an emerging growth company or smaller reporting company as defined in federal securities regulations; and |
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• |
other risks and uncertainties, including those listed under the caption “Risk Factors.” |
Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events and with respect to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described under Part II, Item 1A, “Risk Factors” and elsewhere in this Quarterly Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
All of our forward-looking statements are as of the date of this Quarterly Report only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of or any material adverse change in one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the Securities and Exchange Commission, or the SEC, could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report that modify or impact any of the forward-looking statements contained in this Quarterly Report will be deemed to modify or supersede such statements in this Quarterly Report.
We may from time to time provide estimates, projections and other information concerning our industry, the general business environment, and the markets for certain diseases, including estimates regarding the potential size of those markets and the estimated incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events, circumstances or numbers, including actual disease prevalence rates and market size, may differ materially from the information reflected in this Quarterly Report. Unless otherwise expressly stated, we obtained this industry, business information, market data, prevalence information and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources, in some cases applying our own assumptions and analysis that may, in the future, prove not to have been accurate.
iii
Table of Contents
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|
Page |
PART I. |
1 |
|
Item 1. |
1 |
|
|
1 |
|
|
2 |
|
|
2 |
|
|
Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
3 |
|
5 |
|
|
Notes to Unaudited Condensed Consolidated Financial Statements |
6 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
20 |
Item 3. |
29 |
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Item 4. |
29 |
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PART II. |
30 |
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Item 1. |
30 |
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Item 1A. |
30 |
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Item 2. |
72 |
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Item 3. |
72 |
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Item 4. |
72 |
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Item 5. |
72 |
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Item 6. |
73 |
|
74 |
iv
KYMERA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except for share and per share amounts)
(Unaudited)
|
|
March 31, 2021 |
|
|
December 31, 2020 |
|
||
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
53,098 |
|
|
$ |
31,004 |
|
Marketable securities (Note 4) |
|
|
280,439 |
|
|
|
265,198 |
|
Accounts receivable—due from related parties |
|
|
856 |
|
|
|
577 |
|
Contract assets—due from related parties |
|
|
878 |
|
|
|
856 |
|
Prepaid expenses and other current assets |
|
|
5,520 |
|
|
|
4,704 |
|
Total current assets |
|
$ |
340,791 |
|
|
$ |
302,339 |
|
Marketable securities, non-current (Note 4) |
|
|
101,639 |
|
|
|
162,531 |
|
Property and equipment, net (Note 6) |
|
|
10,752 |
|
|
|
10,841 |
|
Right-of-use assets, operating leases |
|
|
9,750 |
|
|
|
9,845 |
|
Other non-current assets |
|
|
30 |
|
|
|
30 |
|
Restricted cash |
|
|
1,590 |
|
|
|
1,589 |
|
Total assets |
|
$ |
464,552 |
|
|
$ |
487,175 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
8,348 |
|
|
$ |
4,368 |
|
Accrued expenses (Note 8) |
|
|
10,572 |
|
|
|
10,330 |
|
Deferred revenue |
|
|
87,912 |
|
|
|
92,552 |
|
Operating lease liabilities |
|
|
2,408 |
|
|
|
2,572 |
|
Finance lease liabilities |
|
|
640 |
|
|
|
689 |
|
Other current liabilities |
|
|
257 |
|
|
|
106 |
|
Total current liabilities |
|
$ |
110,137 |
|
|
$ |
110,617 |
|
Non-current liabilities |
|
|
|
|
|
|
|
|
Deferred revenue, net of current portion |
|
|
64,654 |
|
|
|
77,838 |
|
Operating lease liabilities, net of current portion |
|
|
13,924 |
|
|
|
14,128 |
|
Finance lease liabilities, net of current portion |
|
|
498 |
|
|
|
604 |
|
Other non-current liabilities |
|
|
92 |
|
|
|
100 |
|
Total liabilities |
|
$ |
189,305 |
|
|
$ |
203,287 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 0 shares issued or outstanding as of March 31, 2021 and December 31, 2020 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 150,000,000 shares authorized at March 31, 2021 and December 31, 2020, 44,971,052 and 44,592,288 shares issued at March 31, 2021 and December 31, 2020, respectively; 44,879,376 and 44,482,186 shares outstanding at March 31, 2021 and December 31, 2020, respectively |
|
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
417,096 |
|
|
|
412,777 |
|
Accumulated deficit |
|
|
(141,840 |
) |
|
|
(128,765 |
) |
Accumulated other comprehensive loss |
|
|
(13 |
) |
|
|
(128 |
) |
Total stockholders’ equity |
|
|
275,247 |
|
|
|
283,888 |
|
Total liabilities and stockholders’ equity |
|
$ |
464,552 |
|
|
$ |
487,175 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
1
KYMERA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Three Months Ended March 31, 2021 and 2020
(In thousands, except for share and per share amounts)
(Unaudited)
|
|
Three Months Ended March 31, |
|
|||||
|
|
2021 |
|
|
2020 |
|
||
Collaboration Revenue—from related parties |
|
$ |
18,702 |
|
|
$ |
3,428 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
25,962 |
|
|
$ |
12,116 |
|
General and administrative |
|
|
5,909 |
|
|
|
2,559 |
|
Total operating expenses |
|
|
31,871 |
|
|
|
14,675 |
|
Loss from operations |
|
|
(13,169 |
) |
|
|
(11,247 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest Income |
|
|
118 |
|
|
|
349 |
|
Interest Expense |
|
|
(24 |
) |
|
|
(34 |
) |
Total other income: |
|
|
94 |
|
|
|
315 |
|
Net loss |
|
$ |
(13,075 |
) |
|
$ |
(10,932 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
Unrealized gain on marketable securities |
|
|
115 |
|
|
|
214 |
|
Total comprehensive loss |
|
$ |
(12,960 |
) |
|
$ |
(10,718 |
) |
Reconciliation of net loss to net loss attributable to common stockholders: |
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(13,075 |
) |
|
$ |
(10,932 |
) |
Deemed dividend from exchange of convertible preferred stock |
|
|
— |
|
|
|
(9,050 |
) |
Net loss attributable to common stockholders |
|
$ |
(13,075 |
) |
|
$ |
(19,982 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
(0.29 |
) |
|
$ |
(10.23 |
) |
Weighted average common stock outstanding, basic and diluted |
|
|
44,649,572 |
|
|
|
1,952,667 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
KYMERA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
For the three months ended March 31, 2021
(In thousands, except for share amounts)
(Unaudited)
|
Common Stock |
|
Additional Paid in |
|
Accumulated |
|
Accumulated Other Comprehensive |
|
'Total Stockholders’ |
|
||||||||
|
Shares |
|
Value |
|
Capital |
|
Deficit |
|
Loss |
|
Equity |
|
||||||
Balance at December 31, 2020 |
|
44,482,186 |
|
$ |
4 |
|
|
412,777 |
|
$ |
(128,765 |
) |
$ |
(128 |
) |
$ |
283,888 |
|
Exercise of stock options |
|
378,762 |
|
|
— |
|
|
1,147 |
|
|
— |
|
|
— |
|
|
1,147 |
|
Vesting restricted stock |
|
18,428 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Stock-based compensation expense |
|
— |
|
|
— |
|
|
3,172 |
|
|
— |
|
|
— |
|
|
3,172 |
|
Unrealized gain on marketable securities |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
115 |
|
|
115 |
|
Net Loss |
|
— |
|
|
— |
|
|
— |
|
|
(13,075 |
) |
|
— |
|
|
(13,075 |
) |
Balance at March 31, 2021 |
|
44,879,376 |
|
$ |
4 |
|
$ |
417,096 |
|
$ |
(141,840 |
) |
$ |
(13 |
) |
$ |
275,247 |
|
3
KYMERA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) (continued)
For the three months ended March 31, 2020
(In thousands, except for share amounts)
(Unaudited)
|
Series Seed Convertible Preferred Stock |
|
Series A Convertible Preferred Stock |
|
Series B Convertible Preferred Stock |
|
Series B-1 Convertible Preferred Stock |
|
Series C Convertible Preferred Stock |
|
|
|
Common Stock |
|
Additional Paid in |
|
Accumulated |
|
Accumulated Other Comprehensive |
|
Total Stockholders' Equity |
|
||||||||||||||||||||||||||||
|
Shares |
|
Value |
|
Shares |
|
Value |
|
Shares |
|
Value |
|
Shares |
|
Value |
|
Shares |
|
Value |
|
|
|
Shares |
|
Value |
|
Capital |
|
Deficit |
|
Income |
|
(Deficit) |
|
||||||||||||||||
Balance at December 31, 2019 |
|
3,000,000 |
|
$ |
5,900 |
|
|
14,720,126 |
|
$ |
29,237 |
|
|
14,827,580 |
|
$ |
59,918 |
|
|
3,059,695 |
|
$ |
14,025 |
|
|
— |
|
$ |
— |
|
|
|
|
1,929,516 |
|
$ |
— |
|
|
2,044 |
|
$ |
(76,456 |
) |
$ |
6 |
|
$ |
(74,406 |
) |
Vesting of Series A Preferred Stock in connection with collaboration arrangement (Note 5) |
|
— |
|
|
— |
|
|
55,394 |
|
|
111 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Issuance of Series B Preferred Stock, net of issuance costs of $0 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,182,265 |
|
|
4,800 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Issuance of Series C Preferred Stock, net of issuance costs of $320 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
13,539,141 |
|
|
88,180 |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Exchange of Series A Convertible Preferred Stock for Series C Preferred Convertible Preferred Stock |
|
— |
|
|
— |
|
|
(1,988,802 |
) |
|
(3,950 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,988,802 |
|
|
13,000 |
|
|
|
|
— |
|
|
— |
|
|
(2,333 |
) |
|
(6,717 |
) |
|
— |
|
|
(9,050 |
) |
Vesting restricted stock |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
46,297 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Stock-based compensation expense |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
371 |
|
|
— |
|
|
— |
|
|
371 |
|
Unrealized gain on marketable securities |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
214 |
|
|
214 |
|
Net Loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
(10,932 |
) |
|
— |
|
|
(10,932 |
) |
Balance at March 31, 2020 |
|
3,000,000 |
|
$ |
5,900 |
|
|
12,786,718 |
|
$ |
25,398 |
|
|
16,009,845 |
|
$ |
64,718 |
|
|
3,059,695 |
|
$ |
14,025 |
|
|
15,527,943 |
|
$ |
101,180 |
|
|
|
|
1,975,813 |
|
$ |
— |
|
$ |
82 |
|
$ |
(94,105 |
) |
$ |
220 |
|
$ |
(93,803 |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
KYMERA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the three months ended March 31, 2021 and 2020
(In thousands)
(Unaudited)
|
|
Three Months Ended March 31, |
|
|||||
|
|
2021 |
|
|
2020 |
|
||
Operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(13,075 |
) |
|
$ |
(10,932 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
3,172 |
|
|
|
371 |
|
Depreciation and amortization |
|
|
485 |
|
|
|
387 |
|
Premiums and discounts on available-for-sale marketable securities |
|
|
1,279 |
|
|
|
— |
|
Non-cash research and development expense |
|
|
— |
|
|
|
111 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
(816 |
) |
|
|
(1,477 |
) |
Receivables—due from related parties |
|
|
(279 |
) |
|
|
— |
|
Contract asset—due from related parties |
|
|
(22 |
) |
|
|
— |
|
Accounts payable |
|
|
4,150 |
|
|
|
(161 |
) |
Accrued expenses and other current liabilities |
|
|
235 |
|
|
|
690 |
|
Deferred revenue |
|
|
(17,822 |
) |
|
|
(3,428 |
) |
Operating lease right-of-use assets |
|
|
95 |
|
|
|
4,295 |
|
Operating lease liabilities |
|
|
(368 |
) |
|
|
(1,913 |
) |
Other liabilities |
|
|
143 |
|
|
|
— |
|
Net cash used in operating activities |
|
$ |
(22,823 |
) |
|
$ |
(12,057 |
) |
Investing activities |
|
|
|
|
|
|
|
|
Purchase of property and equipment, net |
|
|
(164 |
) |
|
|
(1,395 |
) |
Purchases of investments |
|
|
(16,013 |
) |
|
|
(36,008 |
) |
Maturities of investments |
|
|
60,500 |
|
|
|
— |
|
Net cash provided by (used in) investing activities |
|
$ |
44,323 |
|
|
$ |
(37,403 |
) |
Financing activities |
|
|
|
|
|
|
|
|
Proceeds from the issuance of Series B Convertible Preferred Stock, net of issuance costs |
|
|
— |
|
|
|
4,800 |
|
Proceeds from the issuance of Series C Convertible Preferred Stock, net of issuance costs |
|
|
— |
|
|
|
88,462 |
|
Proceeds from stock option exercises |
|
|
1,147 |
|
|
|
— |
|
Payments of offering costs in connection with initial public offering |
|
|
(397 |
) |
|
|
— |
|
Payments on finance leases |
|
|
(155 |
) |
|
|
(142 |
) |
Net cash provided by financing activities |
|
$ |
595 |
|
|
$ |
93,120 |
|
Net increase in cash, cash equivalents and restricted cash |
|
|
22,095 |
|
|
|
43,660 |
|
Cash, cash equivalents and restricted cash at beginning of period |
|
|
32,593 |
|
|
|
77,789 |
|
Cash, cash equivalents and restricted cash at end of period |
|
$ |
54,688 |
|
|
$ |
121,449 |
|
Supplemental disclosure of cash flow activities |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
24 |
|
|
$ |
34 |
|
Supplemental disclosure of noncash investing and financing activities |
|
|
|
|
|
|
|
|
Offering costs included in accrued liabilities |
|
$ |
— |
|
|
$ |
281 |
|
Property and equipment purchases included in accounts payable and accrued expenses |
|
$ |
259 |
|
|
$ |
1,714 |
|
The following table provides a reconciliation of the cash, cash equivalents, and restricted cash balances as of each of the periods shown above:
|
|
March 31, |
|
|||||
|
|
2021 |
|
|
2020 |
|
||
Cash and cash equivalents |
|
$ |
53,098 |
|
|
$ |
121,250 |
|
Restricted cash |
|
|
1,590 |
|
|
|
199 |
|
Total cash, cash equivalents, and restricted cash |
|
$ |
54,688 |
|
|
$ |
121,449 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
KYMERA THERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. Organization and Nature of Business
Kymera Therapeutics, Inc., together with its subsidiary Kymera Securities Corporation, is referred to on a consolidated basis as the “Company”. The Company is a biopharmaceutical company focused on discovering and developing small molecule therapeutics that selectively degrade disease-causing proteins by harnessing the body’s own natural cellular process, a method known as targeted protein degradation. The Company has devoted its efforts principally to research and development since formation. The Company has not yet completed product development, filed for or obtained regulatory approvals for any products, nor verified the market acceptance and demand for such products. As a result, the Company is subject to a number of risks common to emerging companies in the biotech industry. Principal among these risks are the uncertainties of the product discovery and development process, dependence on key individuals, development of the same or similar technological innovations by the Company’s competitors, protection of proprietary technology, compliance with government regulations and approval requirements, the Company’s ability to access capital and uncertainty of market acceptance of products.
The Company has historical net losses and anticipates that it will continue to incur losses for the foreseeable future and had an accumulated deficit of $141.8 million as of March 31, 2021. The Company has funded these losses principally through issuance of common stock, including its initial public offering (“IPO”), which was completed in August 2020, preferred stock, convertible notes and from cash proceeds received in connection with the Company’s collaboration agreements with Vertex Pharmaceuticals Incorporated (“Vertex”) and Genzyme Corporation (“Sanofi”) (see Note 5). The Company expects to continue to incur operating losses and negative cash flows until such time as it generates a level of revenue that is sufficient to support its cost structure.
As of March 31, 2021, the Company had cash, cash equivalents and marketable securities of $435.2 million. The Company believes these cash, cash equivalents and marketable securities will be sufficient to fund its operations and capital expenditure requirements through at least twelve months from the issuance of these condensed consolidated financial statements.
The Company expects to finance the future research and development costs of its product portfolio with its existing cash, cash equivalents and marketable securities, or through strategic financing opportunities that could include, but are not limited to future offerings of its equity, collaboration agreements, or the incurrence of debt. However, there is no guarantee that any of these strategic or financing opportunities will be executed or realized on favorable terms, if at all, and some could be dilutive to existing stockholders. If the Company fails to obtain additional future capital, it may be unable to complete its planned preclinical studies and clinical trials.
Reverse Stock Split
On August 20, 2020, the Board approved a 1-for-1.5949 reverse stock split of the Company’s issued and outstanding shares of common stock and a proportional adjustment to the existing conversion ratios for each of the Company’s outstanding series of preferred stock. All share and per share amounts in the accompanying condensed consolidated financial statements and notes thereto have been retroactively adjusted for all periods presented to give effect to this reverse stock split, including reclassifying an amount equal to the reduction in par value of common stock to additional paid-in capital.
Initial Public Offering
On August 20, 2020, the Company’s registration statement on Form S-1 relating to its initial public offering of its common stock was declared effective by the Securities and Exchange Commission (“SEC”). In the IPO, which closed on August 25, 2020, the Company issued and sold 9,987,520 shares of common stock, including full exercise of the underwriters’ over-allotment option to purchase an additional 1,302,720 shares, at a public offering price of $20.00 per share and the aggregate gross proceeds before deducting underwriting discounts and commissions, and other estimated offering expenses payable by the Company, were approximately $199.8 million. Concurrent with the IPO, the Company issued and sold 676,354 shares of common stock at $20.00 per share in a private placement to Vertex and the aggregate proceeds were $13.5 million.
2. Summary of Significant Accounting Policies
The accompanying consolidated financial statements reflect the application of certain significant accounting policies as described in this note, and elsewhere in the accompanying condensed consolidated financial statements and notes.
6
KYMERA THERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
Principles of Consolidation
The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary Kymera Securities Corporation. All intercompany transactions and balances have been eliminated in consolidation.
Basis of Presentation
The unaudited interim condensed consolidated financial statements of the Company included herein have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) as found in the Accounting Standards Codification (“ASC”), Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”) and the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 11, 2021.
The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2020, and, in the opinion of management, reflect all adjustments necessary, all of which were normal and recurring, for the fair statement of the Company’s financial position as of March 31, 2021, and the results of operations and cash flows for the three months ended March 31, 2021 and 2020. The results for the three months ended March 31, 2021 are not necessarily indicative of the results for the year ended December 31, 2021 or for any future period.
Significant Accounting Policies
The significant accounting policies used in preparation of these condensed consolidated financial statements for the three months ended March 31, 2021 are consistent with those discussed in Note 2 to the consolidated financial statements in the 2020 Annual Report on Form 10-K.
Recent Accounting Pronouncements
Recently Adopted Accounting Standards
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which is intended to simplify the accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. The new standard was effective beginning January 1, 2021. The Company adopted this standard as of January 1, 2021 and it did not have a material impact on its financial position or results of operation.
Recently Issued Accounting Standards Not Yet Adopted
In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements. The new standard requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. As an emerging growth company, the Company expects to delay adoption until January 1, 2023 and is evaluating the impact that the adoption of ASU 2016-13 will have on its condensed consolidated financial statements.
7
KYMERA THERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
3. Fair Value Measurements
The following table presents information about the Company’s financial assets measured at fair value on a recurring basis and indicates the level of the fair value hierarchy utilized to determine such fair values as of March 31, 2021 and December 31, 2020 (in thousands):
|
|
Fair Value Measurements at March 31, 2021: |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market fund |
|
$ |
23,321 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
23,321 |
|
Marketable securities, current |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US treasuries |
|
|
201,758 |
|
|
|
— |
|
|
|
— |
|
|
|
201,758 |
|
Corporate bonds |
|
|
— |
|
|
|
78,681 |
|
|
|
— |
|
|
|
78,681 |
|
Marketable securities, non-current |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US treasuries |
|
|
86,799 |
|
|
|
— |
|
|
|
— |
|
|
|
86,799 |
|
Corporate bonds |
|
|
— |
|
|
|
14,840 |
|
|
|
— |
|
|
|
14,840 |
|
Restricted cash |
|
|
1,590 |
|
|
|
— |
|
|
|
— |
|
|
|
1,590 |
|
Total |
|
$ |
313,468 |
|
|
$ |
93,521 |
|
|
$ |
— |
|
|
$ |
406,989 |
|
|
|
Fair Value Measurements at December 31, 2020: |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market fund |
|
$ |
19,943 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
19,943 |
|
Corporate bonds |
|
|
— |
|
|
|
10,499 |
|
|
|
— |
|
|
|
10,499 |
|
Marketable securities, current |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US treasuries |
|
|
192,275 |
|
|
|
— |
|
|
|
— |
|
|
|
192,275 |
|
Corporate bonds |
|
|
— |
|
|
|
72,923 |
|
|
|
— |
|
|
|
72,923 |
|
Marketable securities, non-current |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US treasuries |
|
|
132,589 |
|
|
|
— |
|
|
|
— |
|
|
|
132,589 |
|
Corporate bonds |
|
|
— |
|
|
|
29,942 |
|
|
|
— |
|
|
|
29,942 |
|
Restricted cash |
|
|
1,589 |
|
|
|
— |
|
|
|
— |
|
|
|
1,589 |
|
Total |
|
$ |
346,396 |
|
|
$ |
113,364 |
|
|
$ |
— |
|
|
$ |
459,760 |
|
During the three months ended March 31, 2021 and the year ended December 31, 2020, there were no transfers between Level 1, Level 2 and Level 3.
4. Marketable Securities
The following table summarizes the available-for-sale debt securities held at March 31, 2021 and December 31, 2020 and (in thousands):
Description |
|
Amortized Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
||||
March 31, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury securities |
|
$ |
288,541 |
|
|
$ |
16 |
|
|
$ |
— |
|
|
$ |
288,557 |
|
Corporate securities |
|
|
93,557 |
|