Cogent Biosciences, Inc. [COGT] Filings

10-Q 1 cogt-20230930.htm 10-Q 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 September 30, 2023

☐ 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 November 3, 2023, there were 86,124,249 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 strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth 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, increasing 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 that are or may 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	5
	Notes to Unaudited Condensed Consolidated Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	27
Item 4.	Controls and Procedures	27
	PART II—OTHER INFORMATION
Item 1.	Legal Proceedings	28
Item 1A.	Risk Factors	28
Item 2.	Recent Sales of Unregistered Securities and Use of Proceeds	28
Item 3.	Defaults Upon Senior Securities	28
Item 4.	Mine Safety Disclosures	28
Item 5.	Other Information	28
Item 6.	Exhibits	29
Signatures		30

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)


	September 30,			December 31,
	2023			2022
Assets
Current assets:
Cash and cash equivalents	$	86,810		$	139,886
Short-term marketable securities		192,231			119,390
Prepaid expenses and other current assets		6,912			4,435
Restricted cash		—			1,255
Total current assets		285,953			264,966
Long-term marketable securities		33,794			—
Operating lease, right-of-use asset		22,194			23,316
Property and equipment, net		8,643			7,783
Other assets		4,862			4,745
Total assets	$	355,446		$	300,810
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	9,868		$	5,842
Accrued expenses and other current liabilities		23,507			17,884
CVR liability (Note 3)		—			1,700
Operating lease liability		1,344			1,423
Total current liabilities		34,719			26,849
Operating lease liability, net of current portion		17,829			18,226
Total liabilities		52,548			45,075
Commitments and contingencies (Note 7)
Stockholders’ equity:
Preferred stock, $0.001 par value; 9,000,000 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 and 81,050 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively		60,035			65,830
Common stock, $0.001 par value; 150,000,000 shares authorized; 86,124,249 shares and 69,893,434 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively		86			70
Additional paid-in capital		792,208			601,153
Accumulated other comprehensive loss		(172	)		(104	)
Accumulated deficit		(549,259	)		(411,214	)
Total stockholders’ equity		302,898			255,735
Total liabilities and stockholders’ equity	$	355,446		$	300,810

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 September 30,						Nine Months Ended September 30,
	2023			2022			2023			2022
Operating expenses:
Research and development	$	50,127		$	29,936		$	125,036		$	84,885
General and administrative		9,453			6,885			24,866			19,209
Total operating expenses		59,580			36,821			149,902			104,094
Loss from operations		(59,580	)		(36,821	)		(149,902	)		(104,094	)
Other income:
Interest income		4,198			1,500			9,207			1,879
Other income, net		—			259			950			1,592
Change in fair value of CVR liability		—			—			1,700			—
Total other income, net		4,198			1,759			11,857			3,471
Net loss	$	(55,382	)	$	(35,062	)	$	(138,045	)	$	(100,623	)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.64	)	$	(0.50	)	$	(1.79	)	$	(1.84	)
Weighted average common shares outstanding, basic and diluted		86,165,951			69,576,359			77,274,580			54,780,041
Comprehensive loss:
Net loss	$	(55,382	)	$	(35,062	)	$	(138,045	)	$	(100,623	)
Other comprehensive loss:
Net unrealized losses on marketable securities		(75	)		(163	)		(68	)		(163	)
Total other comprehensive loss		(75	)		(163	)		(68	)		(163	)
Comprehensive loss	$	(55,457	)	$	(35,225	)	$	(138,113	)	$	(100,786	)

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						Common Stock				Additional Paid-in		Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares			Amount			Shares		Amount		Capital		Income (Loss)			Deficit			Equity
Balances at December 31, 2022		81,050		$	65,830			69,893,434	$	70	$	601,153	$	(104	)	$	(411,214	)	$	255,735
Conversion of Series A non-voting preferred stock into common stock		(4,000	)		(3,520	)		1,000,000		1		3,519		—			—			—
Issuance of common stock under Employee Stock Purchase Plan		—			—			39,228		—		313		—			—			313
Issuance of common stock upon exercise of stock options		—			—			14,128		—		132		—			—			132
Unrealized gains on marketable securities		—			—			—		—		—		120			—			120
Stock-based compensation expense		—			—			—		—		5,850		—			—			5,850
Net loss		—			—			—		—		—		—			(38,587	)		(38,587	)
Balances at March 31, 2023		77,050		$	62,310			70,946,790	$	71	$	610,967	$	16		$	(449,801	)	$	223,563
Issuance of common stock in underwritten public offering, net of offering costs of $10.7 million		—			—			14,375,000		14		161,775		—			—			161,789
Issuance of common stock upon exercise of stock options		—			—			12,375		—		102		—			—			102
Unrealized losses on marketable securities		—			—			—		—		-		(113	)		—			(113	)
Stock-based compensation expense		—			—			—		—		7,163		—			—			7,163
Net loss		—			—			—		—		-		—			(44,076	)		(44,076	)
Balances at June 30, 2023		77,050		$	62,310			85,334,165	$	85	$	780,007	$	(97	)	$	(493,877	)	$	348,428
Conversion of Series A non-voting preferred stock into common stock		(2,585	)		(2,275	)		646,250		1		2,274		—			—			—
Issuance of common stock upon exercise of stock options		—			—			97,184		—		731		—			—			731
Issuance of common stock under Employee Stock Purchase Plan		—			—			46,650		—		439		—			—			439
Unrealized losses on marketable securities		—			—			—		—		—		(75	)		—			(75	)
Stock-based compensation expense		—			—			—		—		8,757		—			—			8,757
Net loss		—			—			—		—		—		—			(55,382	)		(55,382	)
Balances at September 30, 2023		74,465		$	60,035			86,124,249	$	86	$	792,208	$	(172	)	$	(549,259	)	$	302,898


	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, 2021		103,289		$	85,400			43,805,922	$	44	$	399,713	$	—		$	(270,973	)	$	214,184
Conversion of Series A non-voting preferred stock into common stock		(7,955	)		(7,000	)		1,988,750		2		6,998		—			—			—
Issuance of common stock to settle CVR liability		—			—			18,995		—		129		—			—			129
Issuance of common stock for services		—			—			5,599		—		9		—			—			9
Stock-based compensation expense		—			—			—		—		4,175		—			—			4,175
Net loss		—			—			—		—		—		—			(30,634	)		(30,634	)
Balances at March 31, 2022		95,334		$	78,400			45,819,266	$	46	$	411,024	$	-		$	(301,607	)	$	187,863
Issuance of common stock and pre-funded warrants in underwritten public offering, net of offering costs of $10.8 million		—			—			17,899,698		18		161,897		—			—			161,915
Conversion of Series A non-voting preferred stock into common stock		(7,955	)		(7,000	)		1,988,750		2		6,998		—			—			—
Stock-based compensation expense		—			—			—		—		4,534		—			—			4,534
Net loss		—			—			—		—		—		—			(34,927	)		(34,927	)
Balances at June 30, 2022		87,379		$	71,400			65,707,714	$	66	$	584,453	$	-		$	(336,534	)	$	319,385
Conversion of Series A non-voting preferred stock into common stock		(6,329	)		(5,570	)		1,582,250		2		5,568		—			—			—
Pre-funded warrant exercise		—			—			2,424,242		2		22		—			—			24
Issuance of common stock under Employee Stock Purchase Plan		—			—			30,005		—		222		—			—			222
Issuance of common stock upon exercise of stock options		—			—			113,761		—		914		—			—			914
Net unrealized losses on marketable securities		—			—			—		—		—		(163	)		—			(163	)
Stock-based compensation expense		—			—			—		—		4,622		—			—			4,622
Net loss		—			—			—		—		—		—			(35,062	)		(35,062	)
Balances at September 30, 2022

Cogent Biosciences, Inc. [COGT] Filings
10-Q	[2023-11-07]
10-Q	[2023-08-08]
10-Q	[2023-05-09]
10-K	[2023-03-14]
10-Q	[2022-11-14]
10-Q	[2022-08-09]
10-Q	[2022-05-10]
10-K	[2022-03-15]
10-Q	[2021-11-10]
10-Q	[2021-08-16]
10-Q	[2021-05-12]
10-K	[2021-03-16]
10-Q	[2020-11-09]
10-Q	[2020-08-11]
10-Q	[2020-05-11]
10-K	[2020-03-26]
10-Q	[2019-11-12]
10-Q	[2019-08-12]
10-Q	[2019-05-13]
10-K	[2019-03-28]
10-Q	[2018-11-13]
10-Q	[2018-08-13]
10-Q	[2018-05-14]
S-1	[2018-03-02]