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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 February 26, 2024, 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 February 26, 2024, 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: February 26, 2024 |
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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 2023 Financial Results
SUMMIT Part 2 registration-directed study of bezuclastinb in NonAdvSM patients initiated and actively enrolling at 40 sites globally; once-daily 100 mg selected as RP2D; topline results expected by YE 2025
PEAK Phase 3 study of bezuclastinib + sunitinib in 2nd-line GIST patients on track to complete enrollment by end of 2024; topline results expected by YE 2025
APEX Part 2 registration-directed study of bezuclastinib in AdvSM patients on track to complete enrollment by end of 2024; topline results expected by mid-2025
$487 million in pro-forma cash sufficient to fund operations into 2027; includes net proceeds from oversubscribed $225 million February 2024 PIPE
WALTHAM, Mass. and BOULDER, Colo., February 26, 2024 -- 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 2023.
“We have entered 2024 in a very strong position,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We are now actively enrolling three registration-directed clinical trials of bezuclastinib across NonAdvSM, AdvSM and 2nd-line GIST patients, all of which are on track to deliver top-line results in 2025. With our recent fundraising, we are funded into 2027, and based on the clinical data we have presented across these programs to date, believe strongly that bezuclastinib has the opportunity to become the best-in-class KIT mutant inhibitor for these three indications.”
Q4 2023 and Recent Business Highlights
Projected Near-Term Milestones
Bezuclastinib – Systemic Mastocytosis (SM)
Bezuclastinib – Gastrointestinal Stromal Tumors (GIST)
CGT4859 (FGFR2 inhibitor)
Preclinical Pipeline
Upcoming Investor Conference
Fourth Quarter and Full Year 2023 Financial Results
Cash and Cash Equivalents: As of December 31, 2023, Cogent had cash, cash equivalents and marketable securities of $273.2 million. Cogent believes this year-end balance, together with the gross proceeds from the $225.0 million oversubscribed private placement, which closed February 16, 2024, will be sufficient to fund its operating expenses and capital expenditure requirements into 2027, including through clinical readouts from the ongoing SUMMIT, PEAK and APEX registration-directed trials.
R&D Expenses: Research and development expenses were $48.7 million for the fourth quarter of 2023 and $173.8 million for the year ended December 31, 2023, as compared to $36.7 million for the fourth quarter of 2022 and $121.6 million for the year ended December 31, 2022. The increase is driven by progress on the APEX, SUMMIT and PEAK trials and the continued development of the research pipeline. During the quarter Cogent also completed and paid for bulk manufacturing campaigns of bezuclastinib to continue supporting the company’s clinical trials. R&D expenses include non-cash stock compensation expense of $4.1 million for the fourth quarter of 2023 and $14.6 million for the year ended December 31, 2023, as compared to $2.4 million for the fourth quarter of 2022 and $8.5 million for the year ended December 31, 2022.
G&A Expenses: General and administrative expenses were $9.5 million for the fourth quarter of 2023 and $34.4 million for the year ended December 31, 2023, as compared to $7.0 million for the fourth quarter of 2022 and $26.2 million for the year ended December 31, 2022. G&A expenses include non-cash stock compensation expense of $4.8 million for the fourth quarter of 2023 and $16.0 million for the year ended December 31, 2023, as compared to $2.6 million for the fourth quarter of 2022 and $9.9 million for the year ended December 31, 2022.
Net Loss: Net loss was $54.4 million for the fourth quarter of 2023 and $192.4 million for the year ended December 31, 2023, as compared to a net loss of $39.6 million for the fourth quarter of 2022 and $140.2 million for the year ended December 31, 2022.
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 mutations in FGFR2, ErbB2 and PI3Kα. 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: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X.
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 expectation for SUMMIT to complete enrollment in the second quarter of 2025 and deliver top-line results by the end of 2025; the expectation for PEAK to complete enrollment by the end of 2024 and to deliver top-line results by the end of 2025; the expectation for APEX to complete enrollment by the end of 2024 and to deliver top-line results by mid-2025; the company’s anticipated cash runway into 2027; the expectation that bezuclastinib has the opportunity to become the best-in-class KIT mutant inhibitor for NonAdvSM, AdvSM and 2nd-line GIST patients; the potential best-in-class potency and selectivity of the company’s ErbB2 inhibitor; plans to provide addition safety, tolerability and patient-reported outcomes data from the open label extension portion of SUMMIT Part 1 during 2024; plans to provide additional clinical results from the PEAK lead-in trial, including longer duration safety and tolerability results along with updated efficacy measures, including ORR and PFS, during 2024; plans to initiate a Phase 1 trial of the first internally-discovered pipeline program, designed as a potent, selective, reversible FGFR2 inhibitor with best-in-class potential, in the second half of 2024; plans to initiate IND-enabling studies for lead candidate from potent, selective ErbB2 program, highlighted by potential best-in-class brain penetrant properties; and plans to select a lead candidate and initiate IND-enabling studies from ongoing PI3Ka program. 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 or 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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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
$ |
48,719 |
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$ |
36,742 |
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$ |
173,755 |
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$ |
121,627 |
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General and administrative |
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9,509 |
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7,003 |
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34,375 |
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26,212 |
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Total operating expenses |
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58,228 |
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43,745 |
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208,130 |
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147,839 |
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Loss from operations |
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(58,228 |
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(43,745 |
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(208,130 |
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(147,839 |
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Other income: |
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Interest income |
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3,870 |
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2,110 |
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13,077 |
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3,989 |
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Other income, net |
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(7) |
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657 |
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943 |
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2, 249 |
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Change in fair value of CVR liability |
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-- |
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1,360 |
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1,700 |
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1,360 |
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Total other income, net |
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3,863 |
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4,127 |
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15,720 |
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7,598 |
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Net loss |
$ |
(54,365 |
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$ |
(39,618 |
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$ |
(192,410 |
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$ |
(140,241 |
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Net loss per share attributable to common stockholders, basic and diluted |
$ |
(0.63 |
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$ |
(0.56 |
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$ |
(2.42 |
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$ |
(2.39 |
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Weighted average common shares outstanding, basic and diluted |
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86,730,309 |
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70,489,607 |
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79,657,942 |
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58,739,713 |
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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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2023 |
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2022 |
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Cash, cash equivalents and marketable securities |
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$ |
273,170 |
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$ |
259,276 |
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Working capital |
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$ |
232,603 |
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$ |
238,117 |
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Total assets |
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$ |
313,437 |
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$ |
300,810 |
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Total liabilities |
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$ |
55,635 |
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$ |
45,075 |
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Total stockholders’ equity |
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$ |
257,802 |
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$ |
255,735 |
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Contact:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653