10-Q

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, 2024

☐ 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: 001-38443

Cogent Biosciences, Inc.

(Exact name of registrant as specified in its charter)

    Delaware

    46-5308248

    (State or other jurisdiction of
incorporation or organization)

    (I.R.S. Employer
Identification Number)

    275 Wyman Street, 3rd Floor
Waltham, Massachusetts

    02451

    (Address of principal executive offices)

    (Zip code)

(617) 945-5576

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

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, $0.001 Par Value

    COGT

    The Nasdaq Global Select 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, 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 May 3, 2024, there were 95,613,396 shares of the registrant’s Common Stock, $0.001 par value per share, outstanding.

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements, which reflect our current views with respect to, among other things, our operations and financial performance. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position,
business strategy and plans, and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important 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 the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “should,” “expects,” “might,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “seek,” “would” or “continue,” or the negative of these terms or other similar expressions. The forward looking statements in this Quarterly Report on Form 10-Q are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in Item 1A. “Risk Factors.” Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Some of the key factors that could cause actual results to differ from our expectations include:

•

the potential impacts of raising additional capital, including dilution to our existing stockholders, restrictions on our operations or requirements that we relinquish rights to our technologies or product candidates;

•

the success, cost, and duration of our product development activities and clinical trials, including the enrollment rates in our clinical trials;

•

the timing of our planned regulatory submissions to the FDA for our bezuclastinib product candidate and any other product candidates we may develop;

•

our ability to obtain and maintain regulatory approval for our bezuclastinib product candidate and any other product candidates we may develop, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;

•

the potential for our identified research priorities to advance our bezuclastinib product candidate or for our teams to discover and develop additional product candidates;

•

the ability to license additional intellectual property rights relating to our bezuclastinib product candidate or future product candidates from third-parties and to comply with our existing or future license agreements and/or collaboration agreements;

•

our ability to commercialize our bezuclastinib product candidate and future product candidates in light of the intellectual property rights of others;

•

our ability to obtain funding for our operations, including funding necessary to complete further discovery, development and commercialization of our existing and future product candidates;

•

the scalability and commercial viability of our manufacturing methods and processes;

•

the commercialization of our product candidates, if approved;

•

our ability to attract collaborators with development, regulatory, and commercialization expertise;

•

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

•

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

•

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

•

regulatory developments in the United States and foreign countries;

•

the impact of adverse business and economic conditions including inflationary pressures, general economic slowdown or a recession, high interest rates, changes in monetary policy, banking institution instability and the prospect of a shutdown of the U.S. federal government;

•

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

•

the development and success of competing therapies that are or may be under development in clinical trials or become available commercially;

•

our ability to attract and retain key scientific and management personnel;

•

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

•

our use of the proceeds from the private placements, sales of our preferred stock and public offerings of our common stock from time to time;

•

our expectations regarding our ability to obtain and maintain intellectual property protection for our bezuclastinib product candidate and future product candidates; and

•

business interruptions resulting from public health crises, which could cause a disruption to the development of our product candidates and adversely impact our business.

While we may elect to update these forward-looking statements at some point in the future, whether as a result of any new information, future events, or otherwise, we have no current intention of doing so except to the extent required by applicable law.

Cogent Biosciences, Inc.

Table of Contents


		Page
	PART I—FINANCIAL INFORMATION
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	14
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	26
	PART II—OTHER INFORMATION
Item 1.	Legal Proceedings	27
Item 1A.	Risk Factors	27
Item 2.	Recent Sales of Unregistered Securities and Use of Proceeds	27
Item 3.	Defaults Upon Senior Securities	27
Item 4.	Mine Safety Disclosures	27
Item 5.	Other Information	27
Item 6.	Exhibits	28
Signatures		29

iii

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

COGENT BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(unaudited)


	March 31,			December 31,
	2024			2023
Assets
Current assets:
Cash and cash equivalents	$	215,801		$	53,229
Short-term marketable securities		219,939			212,481
Prepaid expenses and other current assets		6,163			5,061
Total current assets		441,903			270,771
Long-term marketable securities		—			7,460
Operating lease, right-of-use assets		21,531			21,998
Property and equipment, net		7,815			8,344
Other assets		4,862			4,864
Total assets	$	476,111		$	313,437
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	15,565		$	10,655
Accrued expenses and other current liabilities		19,689			26,127
Operating lease liabilities		1,432			1,386
Total current liabilities		36,686			38,168
Operating lease liabilities, net of current portion		17,091			17,467
Total liabilities		53,777			55,635
Commitments and contingencies (Note 7)
Stockholders’ equity:
Preferred stock, $0.001 par value; 8,979,420 shares authorized; no shares issued or outstanding		—			—
Series A non-voting convertible preferred stock, $0.001 par value; 1,000,000 shares authorized; 74,465 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively		60,035			60,035
Series B non-voting convertible preferred stock, $0.001 par value; 20,580 shares authorized; 20,580 and no shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively		162,118			—
Common stock, $0.001 par value; 150,000,000 shares authorized; 95,613,396 shares and 86,124,249 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively		96			86
Additional paid-in capital		862,096			801,059
Accumulated other comprehensive income (loss)		(39	)		246
Accumulated deficit		(661,972	)		(603,624	)
Total stockholders’ equity		422,334			257,802
Total liabilities and stockholders’ equity	$	476,111		$	313,437

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

COGENT BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

(unaudited)


	Three Months Ended March 31,
	2024			2023
Operating expenses:
Research and development	$	52,705		$	36,038
General and administrative		9,699			7,199
Total operating expenses		62,404			43,237
Loss from operations		(62,404	)		(43,237	)
Other income:
Interest income		4,057			2,268
Other income, net		(1	)		682
Change in fair value of CVR liability		—			1,700
Total other income, net		4,056			4,650
Net loss	$	(58,348	)	$	(38,587	)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.62	)	$	(0.55	)
Weighted average common shares outstanding, basic and diluted		94,804,659			70,734,950
Comprehensive loss:
Net loss	$	(58,348	)	$	(38,587	)
Other comprehensive loss:
Net unrealized losses on marketable securities		(285	)		120
Total other comprehensive loss		(285	)		120
Comprehensive loss	$	(58,633	)	$	(38,467	)

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

COGENT BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(in thousands, except share amounts)

(unaudited)


	Series A Non-Voting Convertible Preferred Stock				Series B Non-Voting Convertible Preferred Stock				Common Stock						Additional Paid-in			Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Shares		Amount		Shares			Amount			Capital			Income (Loss)			Deficit			Equity
Balances at December 31, 2023		74,465	$	60,035		—	$	—		86,124,249		$	86		$	801,059		$	246		$	(603,624	)	$	257,802
Issuance of Series B non-voting convertible preferred stock and common stock, net of issuance costs of $11.6 million, in connection with the Private Placement		—		—		12,280		87,364		17,717,997			18			126,034			—			—		$	213,416
Exchange of common stock for Series B non-voting convertible preferred stock		—		—		8,300		74,754		(8,300,000	)		(8	)		(74,746	)		—			—			—
Issuance of common stock under Employee Stock Purchase Plan		—		—		—		—		71,150			—			356			—			—		$	356
Unrealized gains on marketable securities		—		—		—		—		—			—			—			(285	)		—		$	(285	)
Stock-based compensation expense		—		—		—		—		—			—			9,393			—			—		$	9,393
Net loss		—		—		—		—		—			—			—			—			(58,348	)	$	(58,348	)
Balances at March 31, 2024		74,465	$	60,035		20,580	$	162,118		95,613,396		$	96		$	862,096		$	(39	)	$	(661,972	)	$	422,334


	Series A Non-Voting Convertible Preferred Stock						Common Stock				Additional Paid-in		Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares			Amount			Shares		Amount		Capital		Loss			Deficit			Equity
Balances at December 31, 2022		81,050		$	65,830			69,893,434	$	70	$	601,153	$	(104	)	$	(411,214	)	$	255,735
Unrealized gains on marketable securities		—			—			—		—		—		120			—			120
Conversion of Series A non-voting preferred stock into common stock		(4,000	)		(3,520	)		1,000,000		1		3,519		—			—			—	<

SEC Form 10-Q filed by Cogent Biosciences Inc.