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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On March 14, 2023, Cogent Biosciences, Inc., a Delaware corporation (the “Company”), issued a press release announcing its financial results for the quarter and year ended December 31, 2023. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference in its entirety.
The information in this Item 2.02 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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Press release issued by Cogent Biosciences, Inc. on March 14, 2023, furnished herewith. |
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104 |
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The cover page from the Company’s Current Report on Form 8-K formatted in Inline XBRL. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: March 14, 2023 |
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COGENT BIOSCIENCES, INC. |
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By: |
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/s/ John Green |
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John Green |
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Chief Financial Officer |
Exhibit 99.1
Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2022 Financial Results
Initiation of APEX Part 2 planned for mid-2023
Updated clinical data from Phase 3 PEAK lead-in in GIST patients expected 1H23
Initial clinical data from Phase 2 SUMMIT trial in NonAdvSM on-track for 2H23
Ended 2022 with $259.3 million in cash; sufficient to fund operations into 2025
WALTHAM, Mass. and BOULDER, Colo., March 14, 2023 - Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2022.
“2022 was a pivotal year for Cogent marked by our promising clinical data with bezuclastinib in systemic mastocytosis, the initiation of our Phase 3 PEAK trial in GIST, and the build-out of the Cogent Research Team,” said Andrew Robbins, the company’s President and Chief Executive Officer. “We have laid the foundation for multiple catalysts in 2023 across all our programs. Based on the clinical performance of bezuclastinib, we believe it has the potential to be a best-in-class therapy for patients living with systemic mastocytosis and GIST. We continue to advance therapies that improve the lives of patients with genetically defined rare diseases while positioning ourselves as an industry leader in precision medicine.”
Recent Highlights
Upcoming Milestones
Fourth Quarter and Full Year 2022 Financial Results
Cash and Cash Equivalents: As of December 31, 2022, Cogent had cash, cash equivalents and marketable securities of $259.3 million. The company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into 2025. Cogent holds a de minimis amount of cash related balances at Silicon Valley Bank.
R&D Expenses: Research and development expenses were $36.7 million for the fourth quarter of 2022 and $121.6 million for the year ended December 31, 2022, as compared to $20.5 million for the fourth quarter of 2021 and $55.9 million for the year ended December 31, 2021. The increase is primarily a result of bezuclastinib clinical trial activities. R&D expenses include non-cash stock compensation expense of $2.4 million for the fourth quarter of 2022 and $8.5 million for the year ended December 31, 2022, as compared to $1.7 million for the fourth quarter of 2021 and $4.4 million for the year ended December 31, 2021.
G&A Expenses: General and administrative expenses were $7.0 million for the fourth quarter of 2022 and $26.2 million for the year ended December 31, 2022, as compared to $5.1 million for the fourth quarter of 2021 and $19.6 million for the year ended December 31, 2021. G&A expenses include non-cash stock compensation expense of $2.6 million for the fourth quarter of 2022 and $9.9 million for the year ended December 31, 2022, as compared to $2.1 million for the fourth quarter of 2021 and $7.3 million for the year ended December 31, 2021.
Net Loss: Net loss was $39.6 million for the fourth quarter of 2022 and $140.2 million for the year ended December 31, 2022, as compared to a net loss of $24.9 million for the fourth quarter of 2021 and $72.3 million for the year ended December 31, 2021.
About Cogent Biosciences, Inc.
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting FGFR2 and ErbB2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: Twitter and LinkedIn. Information that may be important to investors will be routinely posted on our website and Twitter.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company’s cash runway, the potential for bezuclastinib to become a best-in-class treatment option for patients living with systemic mastocytosis and GIST, plans to provide a mid-year update on the planned initiation of APEX Part 2 based on clinical data from approximately 25-30 patients in APEX Part 1, plans to present updated clinical data from the Phase 3 PEAK lead-in study during the first half of 2023, plans to start activating clinical trial sites across major countries in the European Union for SUMMIT in April 2023 and to present initial clinical data from SUMMIT in the second half of 2023, and plans to present updated preclinical data from the company’s research programs in April 2023. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
COGENT BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
(unaudited)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
$ |
36,742 |
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$ |
20,514 |
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$ |
121,627 |
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$ |
55,913 |
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General and administrative |
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7,003 |
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5,125 |
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26,212 |
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19,638 |
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Total operating expenses |
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43,745 |
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25,639 |
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147,839 |
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75,551 |
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Loss from operations |
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(43,745 |
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(25,639 |
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(147,839 |
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(75,551 |
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Other income: |
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Interest income |
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2,110 |
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106 |
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3,989 |
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467 |
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Other income, net |
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657 |
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621 |
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2,249 |
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2,468 |
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Change in fair value of CVR liability |
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1,360 |
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— |
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1,360 |
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343 |
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Total other income, net |
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4,127 |
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727 |
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7,598 |
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3,278 |
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Net loss |
$ |
(39,618 |
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$ |
(24,912 |
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$ |
(140,241 |
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$ |
(72,273 |
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Net loss per share attributable to common stockholders, basic and diluted |
$ |
(0.56 |
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$ |
(0.60 |
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$ |
(2.39 |
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$ |
(1.87 |
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Weighted average common shares outstanding, basic and diluted |
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70,489,607 |
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41,666,415 |
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58,739,713 |
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38,730,813 |
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COGENT BIOSCIENCES, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(unaudited)
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December 31, |
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents and marketable securities |
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$ |
259,276 |
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$ |
219,684 |
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Working capital |
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$ |
238,117 |
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$ |
205,556 |
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Total assets |
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$ |
300,810 |
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$ |
232,092 |
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Total liabilities |
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$ |
45,075 |
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$ |
17,908 |
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Total stockholders’ equity |
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$ |
255,735 |
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$ |
214,184 |
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Contact:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653