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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 June 30, 2023

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: 001-38443

 

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 August 4, 2023, there were 85,465,249 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;

i


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.

ii


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

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)

 

 

 

June 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

214,317

 

 

$

139,886

 

Short-term marketable securities

 

 

115,082

 

 

 

119,390

 

Prepaid expenses and other current assets

 

 

5,120

 

 

 

4,435

 

Restricted cash

 

 

 

 

 

1,255

 

Total current assets

 

 

334,519

 

 

 

264,966

 

Long-term marketable securities

 

 

21,512

 

 

 

 

Operating lease, right-of-use asset

 

 

22,468

 

 

 

23,316

 

Property and equipment, net

 

 

9,095

 

 

 

7,783

 

Other assets

 

 

4,775

 

 

 

4,745

 

Total assets

 

$

392,369

 

 

$

300,810

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

7,161

 

 

$

5,842

 

Accrued expenses and other current liabilities

 

 

17,419

 

 

 

17,884

 

CVR liability (Note 3)

 

 

 

 

 

1,700

 

Operating lease liability

 

 

1,177

 

 

 

1,423

 

Total current liabilities

 

 

25,757

 

 

 

26,849

 

Operating lease liability, net of current portion

 

 

18,184

 

 

 

18,226

 

Total liabilities

 

 

43,941

 

 

 

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;
77,050 and 81,050 shares issued and outstanding at
   June 30, 2023 and December 31, 2022, respectively

 

 

62,310

 

 

 

65,830

 

Common stock, $0.001 par value; 150,000,000 shares authorized; 85,334,165
   shares and
69,893,434 shares issued and outstanding at June 30, 2023 and
   December 31, 2022, respectively

 

 

85

 

 

 

70

 

Additional paid-in capital

 

 

780,007

 

 

 

601,153

 

Accumulated other comprehensive loss

 

 

(97

)

 

 

(104

)

Accumulated deficit

 

 

(493,877

)

 

 

(411,214

)

Total stockholders’ equity

 

 

348,428

 

 

 

255,735

 

Total liabilities and stockholders’ equity

 

$

392,369

 

 

$

300,810

 

 

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

1


 

COGENT BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

(unaudited)

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

38,871

 

 

$

29,479

 

 

$

74,909

 

 

$

54,949

 

General and administrative

 

8,214

 

 

 

6,376

 

 

 

15,413

 

 

 

12,324

 

Total operating expenses

 

47,085

 

 

 

35,855

 

 

 

90,322

 

 

 

67,273

 

Loss from operations

 

(47,085

)

 

 

(35,855

)

 

 

(90,322

)

 

 

(67,273

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

2,741

 

 

 

272

 

 

 

5,009

 

 

 

379

 

Other income, net

 

268

 

 

 

656

 

 

 

950

 

 

 

1,333

 

Change in fair value of CVR liability

 

 

 

 

 

 

 

1,700

 

 

 

 

Total other income, net

 

3,009

 

 

 

928

 

 

 

7,659

 

 

 

1,712

 

Net loss

$

(44,076

)

 

$

(34,927

)

 

$

(82,663

)

 

$

(65,561

)

Net loss per share attributable to common stockholders, basic and diluted

$

(0.59

)

 

$

(0.71

)

 

$

(1.14

)

 

$

(1.39

)

Weighted average common shares outstanding, basic and diluted

 

74,753,269

 

 

 

49,388,936

 

 

 

72,755,210

 

 

 

47,259,261

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(44,076

)

 

$

(34,927

)

 

$

(82,663

)

 

$

(65,561

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

Net unrealized gains (losses) on marketable securities

 

(113

)

 

 

 

 

 

7

 

 

 

 

Total other comprehensive loss

 

(113

)

 

 

 

 

 

7

 

 

 

 

Comprehensive loss

$

(44,189

)

 

$

(34,927

)

 

$

(82,656

)

 

$

(65,561

)

 

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

2


 

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

 

 

 

 

 

Series A Non-Voting

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible Preferred
Stock

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

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

 

 

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

3


 

COGENT BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

 

 

Six Months Ended
June 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(82,663

)

 

$

(65,561

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization expense

 

 

1,091

 

 

 

166

 

Stock-based compensation expense

 

 

13,013

 

 

 

8,709

 

Amortization of operating leases, right-of-use assets

 

 

848

 

 

 

1,064

 

Change in fair value of CVR liability

 

 

(1,700

)

 

 

 

Net amortization (accretion) of premiums (discounts) on marketable securities

 

 

(1,780

)

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(685

)

 

 

(909

)

Other assets

 

 

(30

)

 

 

(1,168

)

Accounts payable

 

 

1,319

 

 

 

9

 

Accrued expenses and other current liabilities

 

 

(708

)

 

 

3,173

 

Operating lease liability

 

 

(288

)

 

 

(273

)

Net cash used in operating activities

 

 

(71,583

)

 

 

(54,790

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(2,360

)

 

 

(1,585

)

Purchases of marketable securities

 

 

(185,417

)

 

 

 

Maturities and sales of marketable securities

 

 

170,000

 

 

 

 

Net cash used in investing activities

 

 

(17,777

)

 

 

(1,585

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from issuance of shares of common stock, net of offering costs of $10.7 million

 

 

161,989

 

 

 

 

Proceeds from issuance of shares of common stock and pre-funded warrants, net of offering costs of $10.8 million

 

 

 

 

 

162,115

 

Proceeds from issuance of stock from employee stock purchase plan

 

 

313

 

 

 

129

 

Proceeds from issuance of common stock upon stock option exercises

 

 

234

 

 

 

9

 

Net cash provided by financing activities

 

 

162,536

 

 

 

162,253

 

Net increase in cash, cash equivalents and restricted cash

 

 

73,176

 

 

 

105,878

 

Cash, cash equivalents and restricted cash at beginning of period

 

 

141,141

 

 

 

220,939

 

Cash, cash equivalents and restricted cash at end of period

 

$

214,317

 

 

$

326,817

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

Right-of-use assets obtained in exchange for new operating lease liabilities

 

$

 

 

$

25,184

 

Supplemental disclosure of noncash investing and financing information:

 

 

 

 

 

 

Offering costs included in accounts payable and accrued expenses

 

$

200

 

 

$

200

 

Property & equipment included in accounts payable and accrued expenses

 

$

43

 

 

$

466

 

Conversion of Series A Convertible Preferred stock into common shares

 

$

3,520

 

 

$

14,000

 

 

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

4


 

COGENT BIOSCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

1. Nature of the Business and Basis of Presentation

Cogent Biosciences, Inc. (“Cogent” or the “Company”) is a biotechnology company focused on developing precision therapies for genetically defined diseases. Cogent’s approach is to design rational precision therapies that treat the underlying cause of disease and improve the lives of patients. Cogent’s most advanced program is bezuclastinib, also known as CGT9486, a highly selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. In the vast majority of cases, KIT D816V is responsible for driving Systemic Mastocytosis (“SM”), a serious and rare 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. Bezuclastinib is a highly selective and potent KIT inhibitor with the potential to provide a new treatment option for these patient populations. In addition to bezuclastinib, the Company’s research team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases, and is initially targeting FGFR2 and ErbB2.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.

The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has incurred recurring losses since inception, including a net loss of $82.7 million for the six months ended June 30, 2023. As of June 30, 2023, the Company had an accumulated deficit of $493.9 million. The Company expects to continue to generate operating losses in the foreseeable future. As of the issuance date of the interim condensed consolidated financial statements, the Company expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months from issuance of the condensed consolidated financial statements.

The Company expects that it will continue to incur significant expenses in connection with its ongoing business activities. The Company will need to seek additional funding through equity offerings, debt financings, collaborations, licensing arrangements or other marketing and distribution arrangements, partnerships, joint ventures, combinations or divestitures of one or more of its assets or businesses. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into collaborative arrangements or divest its assets. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. Arrangements with collaborators or others may require the Company to relinquish rights to certain of its technologies or product candidates. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate its research and development programs or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations.

The Company’s condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).

 

5


 

 

2. Summary of Significant Accounting Policies

Unaudited Interim Financial Information

The consolidated balance sheet at December 31, 2022 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of June 30, 2023 and for the three and six months ended June 30, 2023 and 2022 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. 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, 2022 included in the Company’s Annual Report on Form 10-K on file with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2023 and results of operations for the three and six months ended June 30, 2023 and 2022 and cash flows for the six months ended June 30, 2023 and 2022 have been made. The Company’s results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Mono, Inc. and Kiq Bio LLC. All intercompany accounts and transactions have been eliminated.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual of research and development expenses, the valuation of the CVR liability and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions.

Marketable Securities

The Company’s marketable securities, consisting of debt securities, are classified as available-for-sale. Available-for-sale marketable debt securities are carried at fair value with the unrealized gains and losses included in other comprehensive income (loss) as a component of stockholders’ equity until realized. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other income (expense). The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, a loss is recognized in net income, and if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss).

 

6


 

 

3. Marketable Securities and Fair Value of Financial Assets and Liabilities

The following table summarizes the Company’s marketable securities (in thousands):

 

 

 

June 30, 2023

 

 

 

Amortized
Cost

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Fair
Value

 

U.S. Treasury bills and notes (due within one year)

 

$

115,135

 

 

$

8

 

 

$

(61

)

 

$

115,082

 

U.S. Treasury bills and notes (due after one through five years)

 

 

21,556

 

 

 

 

 

 

(44

)

 

 

21,512

 

 

$

136,691

 

 

$

8

 

 

$

(105

)

 

$

136,594

 

 

 

 

December 31, 2022

 

 

 

Amortized
Cost

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Fair
Value

 

U.S. Treasury bills and notes (due within one year)

 

$

119,494

 

 

$

 

 

$

(104

)

 

$

119,390

 

 

 

$

119,494

 

 

$

 

 

$

(104

)

 

$

119,390

 

As of June 30, 2023, the Company held twenty-seven securities that were in an unrealized loss position. The aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months as of June 30, 2023 was $92.1 million and there were no securities held by the Company in an unrealized loss position for more than twelve months. As of December 31, 2022, the Company held seven securities that were in an unrealized loss position. The aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months as of December 31, 2022 was $99.5 million and there were no securities held by the Company in an unrealized loss position for more than twelve months. The Company has the intent and ability to hold such securities until recovery. As a result, the Company did not record any charges for impairments for its marketable debt securities for the three and six months ended June 30, 2023 and for the year ended December 31, 2022.

The following tables present the Company’s fair value hierarchy for its financial assets and liabilities, which are measured at fair value on a recurring basis (in thousands):

 

 

 

Fair Value Measurements at June 30, 2023 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

171,485

 

 

$

 

 

$

 

 

$

171,485

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury bills and notes

 

$

 

 

$

136,594

 

 

$

 

 

$

136,594

 

Total assets

 

$

171,485

 

 

$

136,594

 

 

$

 

 

$

308,079

 

 

 

 

Fair Value Measurements at December 31, 2022 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

108,829

 

 

$

 

 

$

 

 

$

108,829

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury bills and notes

 

$

 

 

$

119,390

 

 

$

 

 

$

119,390

 

Total assets

 

$

108,829

 

 

$

119,390

 

 

$

 

 

$

228,219

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

CVR liability

 

$

 

 

$

 

 

$

1,700

 

 

$

1,700

 

Total liabilities

 

$

 

 

$

 

 

$

1,700

 

 

$

1,700

 

 

7


 

Money market funds were valued using quoted prices in active markets, which represent a Level 1 measurement in the fair value hierarchy. U.S. Treasury bills and notes were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy.

On July 6, 2020, the Company issued a non-transferrable contingent value right (“CVR”), which was distributed to stockholders of record as of the close of business on July 6, 2020, and prior to the issuance of any shares to acquire Kiq Bio LLC (“Kiq”) (the “Kiq Acquisition”) or sold to the Private Investment in Public Equity (“PIPE”) investors. Holders of the CVR are entitled to receive common shares and/or cash payments from proceeds received by the Company, if any, related to the disposition of its legacy cell therapy assets for a period of three years from July 2020. In accordance with the terms of the CVR agreement, the payment to CVR holders will be made in shares or cash, depending on the timing of the receipt of the sales proceeds by the Company. For sales proceeds received by the Company prior to December 31, 2020, CVR holders were entitled to receive payment in the form of common shares of the Company. For sales proceeds received by the Company after December 31, 2020 and prior to July 2023, CVR holders are entitled to receive payment in cash.

The Company classifies the CVR as a liability on its condensed consolidated balance sheet. The fair value of the CVR liability was determined using the probability weighted discounted cash flow method to estimate future cash flows associated with the sale of the legacy cell therapy assets, including the Bolt-on Chimeric Receptor (“BOXR”) technology and Autologous Cell Therapy Industrial Automation technology (collectively, the “BOXR Platform”), Antibody-Coupled T cell Receptor technology and other fixed assets based on assumptions at the date of the CVR issuance and each subsequent quarterly period end, less certain permitted deductions. For sales proceeds received by the Company prior to December 31, 2020, the number of common shares to be received by CVR holders was determined by dividing the proceeds received by the Company by the closing price of the Company’s common stock on July 6, 2020 of $8.80. The closing price of the Company’s common stock at each measurement date through February 2021 was used to determine the fair value of the share payments included in the CVR liability. The liability measured at the date of CVR issuance was recorded as a common stock dividend, returning capital to the legacy stockholders of record as of the close of business on July 6, 2020. Changes in fair value of the liability are recognized as a component of other income (expense) in the condensed consolidated statement of operations and comprehensive loss. The CVR liability was valued based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy.

On August 28, 2020, the Company sold its assets, rights and interests relating to its BOXR Platform, to Sotio. Pursuant to the BOXR Platform Purchase Agreement, Sotio has agreed to pay the Company total cash consideration of up to $11.5 million, consisting of an upfront payment of $8.1 million and potential milestone payments of up to $3.4 million in the aggregate upon the achievement of certain milestones related to the issuance of Specified Claims (as described in the BOXR Platform Purchase Agreement) by the U.S. Patent and Trademark Office and the European Patent Office. The upfront payment was received in 2020. In 2020, the Company also sold additional fixed assets used in the legacy business. Both transactions triggered payment to the CVR holders. In November 2020, the Company issued 707,938 shares of common stock in partial settlement of the CVR liability. In February 2021, the Company issued an additional 212,429 shares of common stock and paid $0.1 million in partial settlement of the CVR liability. Any settlement of the remaining CVR liability will be a cash settlement.

In the fourth quarter of 2022, the Company updated the probability weighted discounted cash flow assumptions to reflect the then current probability of receiving the milestone payments from Sotio prior to the expiration of the CVR. Based on the Company’s assessment of the available information, this update resulted in a decrease in the probability of receiving the milestone payment prior to the expiration of the CVR and a corresponding decrease in the CVR liability of $1.4 million was recognized as a component of other income (expense) in 2022. Based on the Company’s assessment of the information available through the issuance date of the financial statements, the Company recorded an additional decrease in fair value of the liability of $1.7 million in the first quarter of 2023, reducing the liability to zero as the probability of additional CVR payments occurring prior to the expiration of CVR term is remote. The CVRs expired on August 6, 2023 and no further payments will be made to CVR holders.

The following table sets forth a summary of the changes in the fair value of the Company’s CVR liability (in thousands):

Balance at December 31, 2021

 

$

3,060

 

Change in fair value

 

 

(1,360

)

Balance at December 31, 2022

 

$

1,700

 

Change in fair value

 

 

(1,700

)

Balance at June 30, 2023

 

$

 

 

During the three and six months ended June 30, 2023 and 2022, there were no transfers between Level 1, Level 2 and Level 3.

 

8


 

 

4. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

 

 

 

June 30,
2023

 

 

December 31,
2022

 

Accrued employee compensation and benefits

 

$

4,757

 

 

$

6,063

 

Accrued external research and development expense

 

 

8,380

 

 

 

5,898

 

Accrued external manufacturing costs

 

 

1,624

 

 

 

3,741

 

Accrued professional and consulting services

 

 

2,162

 

 

 

1,778

 

Other

 

 

496

 

 

 

404

 

Total

 

$

17,419

 

 

$

17,884

 

 

5. Preferred Stock, Series A Non-Voting Convertible Preferred Stock and Common Stock

The Company’s authorized capital stock consists of 150,000,000 shares of common stock, par value $0.001 per share, and 10,000,000 shares of preferred stock, par value $0.001 per share, 1,000,000 of which are designated as Series A Preferred Stock and 9,000,000 of which shares of preferred stock are undesignated.

Series A Non-Voting Convertible Preferred Stock

On July 6, 2020, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series A Non-Voting Convertible Preferred Stock (“Series A Preferred Stock”) with the Secretary of State of the State of Delaware (the “Certificate of Designation”) in connection with the Kiq Acquisition and the PIPE. The Certificate of Designation provides for the issuance of shares of Series A Preferred Stock, par value $0.001 per share.

Holders of Series A Preferred Stock are entitled to receive dividends on shares of Series A Preferred Stock equal, on an as-if-converted-to-common-stock basis, and in the same form as dividends actually paid on shares of the common stock. Except as otherwise required by law, the Series A Preferred Stock does not have voting rights. However, as long as any shares of Series A Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock, (b) alter or amend the Certificate of Designation, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A Preferred Stock, (d) increase the number of authorized shares of Series A Preferred Stock, (e) prior to the stockholder approval of the Conversion Proposal or at any time while at least 40% of the originally issued Series A Preferred Stock remains issued and outstanding, consummate a Fundamental Transaction (as defined in the Certificate of Designation) or (f) enter into any agreement with respect to any of the foregoing. The Series A Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company.

Each share of Series A Preferred Stock is convertible at any time at the option of the holder thereof, into 250 shares of common stock, subject to certain limitations, including that a holder of Series A Preferred Stock is prohibited from converting shares of Series A Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.9% and 19.9%) of the total number of shares of common stock issued and outstanding immediately after giving effect to such conversion. Cumulatively, through June 30, 2023, 86,275 shares of Series A Preferred Stock, or 52.8% of the issued Series A Preferred Stock, have been converted into 21,568,750 shares of common stock. The 77,050 shares of Series A Preferred Stock outstanding as of June 30, 2023 are convertible into 19,262,500 shares of common stock.

No other classes of preferred stock have been designated and no other preferred shares have been issued or are outstanding as of June 30, 2023.

 

9


 

Common Stock

Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are not entitled to receive dividends, unless declared by the board of directors. In the event of the Company’s liquidation, dissolution or winding up, holders of the Company’s common stock will be entitled to share ratably in all assets remaining after payment of all debts and other liabilities and any liquidation preference of any outstanding preferred stock. The shares to be issued by us in this offering will be, when issued and paid for, validly issued, fully paid and non-assessable.

On May 6, 2022, the Company filed a shelf registration statement on Form S-3 with the SEC. The shelf registration statement allows the Company to sell from time-to-time up to $300.0 million of common stock, preferred stock, debt securities, warrants or units comprised of any combination of these securities, for its own account in one or more offerings. The terms of any offering under the shelf registration statement will be established at the time of such offering and will be described in a prospectus supplement filed with the SEC prior to the completion of any such offering.

Additionally, on May 6, 2022, pursuant to the Form S-3, the Company entered into a Sales Agreement (the “Sales Agreement”) with Guggenheim Securities, LLC (“Guggenheim Securities”), pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $75.0 million through Guggenheim Securities, as the sales agent. As of June 30, 2023, no shares have been sold under the Sales Agreement.

On June 13, 2022, the Company completed an underwritten public offering of 17,899,698 shares of its common stock at a public offering price of $8.25 per share (including the exercise in full by the underwriters of their 30-day option to purchase up to 2,730,000 additional shares of common stock) and, in lieu of common stock to certain investors, pre-funded warrants to purchase 3,030,302 shares of its common stock at a purchase price of $8.24 per underlying share. The net proceeds from the offering were approximately $161.9 million, after deducting the underwriting discounts and commissions of $10.4 million and offering expenses of $0.4 million.

Each pre-funded warrant entitles the holder to purchase shares of common stock at an exercise price of $0.01 per share and is exercisable at any time beginning on the date of issuance. These warrants were recorded as a component of stockholders’ equity within additional paid-in capital. Per the terms of the warrant agreement, a holder of the outstanding warrant is not entitled to exercise any portion of the pre-funded warrant if, upon giving effect to such exercise, would cause the aggregate number of shares of common stock beneficially owned by such holder (together with its affiliates and any other person whose beneficial ownership of common stock would be aggregated with the holder) to exceed 9.99% of the total number of then issued and outstanding shares of common stock, as such percentage ownership is determined in accordance with the terms of the pre-funded warrant and subject to such holder’s rights under the pre-funded warrant to increase or decrease such percentage to any other percentage not in excess of 19.99% upon at least 61 days’ prior notice from such holder. As of June 30, 2023, 2,424,242 pre-funded warrants have been exercised and 606,060 pre-funded warrants remain outstanding.

On February 10, 2023, the Company filed a Form S-3ASR with the SEC (“2023 Shelf Registration”) for the issuance of common stock, preferred stock, warrants, rights, debt securities and units, which became effective immediately upon filing. At the time any of the securities covered by the 2023 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.

In June 2023, the Company completed an underwritten public offering of 14,375,000 shares of its common stock at a public offering price of $12.00 per share (including the exercise in full by the underwriters of their 30-day option to purchase up to 1,875,000 additional shares of common stock). The net proceeds from the offering were approximately $161.8 million, after deducting the underwriting discounts and commissions of $10.3 million and offering expenses of $0.4 million.

6. Stock-Based Compensation

2018 Stock Option and Incentive Plan

The Company’s 2018 Stock Option and Incentive Plan, (the “2018 Plan”), which became effective on March 27, 2018, provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards, cash-based awards and dividend equivalent rights. The number of shares initially reserved for issuance under the 2018 Plan was 700,180. Additionally, the shares of common stock that remained available for issuance under the previously outstanding 2015 Stock Incentive Plan (the “2015 Plan”) became available under the 2018 Plan. The number of shares reserved for the 2018 Plan automatically increases on each January 1 by 4% of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or a lesser number of shares determined by the Company’s board of directors. Additionally, at the Company’s 2021 annual stockholder meeting, the Company’s stockholders approved the amendment and restatement of the 2018 Stock Plan to increase the number of shares of common stock issuable under the 2018 Plan by 6,000,000 shares.

 

10


 

The number of authorized shares reserved for issuance under the 2018 Plan was increased by 2,795,737 shares effective as of January 1, 2023. On June 7, 2023, at the Company’s 2023 annual stockholder meeting, the Company’s stockholders approved the amendment and restatement of the 2018 Plan to increase the number of shares of common stock issuable under the 2018 Plan by an additional 6,000,000 shares (the “2023 Pool Increase”). The shares of common stock underlying any awards that are forfeited, canceled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, repurchased or are otherwise terminated by the Company under the 2018 Plan or the 2015 Plan will be added back to the shares of common stock available for issuance under the 2018 Plan. As of June 30, 2023, 4,022,464 shares of common stock remain available for issuance under the 2018 Plan.

Inducement Plan

On October 22, 2020, the board of directors adopted the Cogent Biosciences, Inc. 2020 Inducement Plan (the “Inducement Plan”). The board of directors also adopted a form of non-qualified stock option agreement for use with the Inducement Plan. A total of 3,750,000 shares of common stock have been reserved for issuance under the Inducement Plan, subject to adjustment for stock dividends, stock splits, or other changes in Cogent’s common stock or capital structure. On November 5, 2020, the Company filed a Registration Statement on Form S-8 related to the 3,750,000 shares of its common stock reserved for issuance under the Inducement Plan. As of June 30, 2023, 677,995 shares of common stock remain available for issuance under the Inducement Plan.

2018 Employee Stock Purchase Plan

The Company’s 2018 Employee Stock Purchase Plan (the “ESPP”) became effective on March 28, 2018, at which time a total of 78,500 shares of common stock were reserved for issuance. In addition, the number of shares of common stock that may be issued under the ESPP automatically increases on each January 1 through January 1, 2027, by the least of (i) 125,000 shares of common stock, (ii) 1% of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or (iii) such lesser number of shares as determined by the ESPP administrator. The number of authorized shares reserved for issuance under the ESPP was increased by 125,000 shares effective as of January 1, 2023. As of June 30, 2023, 490,040 shares remain available for issuance under the ESPP. In July 2023, 46,650 shares were issued to employees under the ESPP.

Performance-based restricted stock units

In February 2023, the Board approved grants in aggregate of up to 2,500,000 performance-based restricted stock units (“PSUs”) under the 2018 Plan, which grants were subject to forfeiture in the event that the Company’s stockholders did not approve the 2023 Pool Increase. On June 7, 2023, stockholders approved the 2023 Pool Increase and a grant date was established for accounting purposes for these PSUs in accordance with ASC 718 Compensation- Stock Compensation. An award holder can generally receive between 0% and 200% of the target award based on achievement of specified stock price hurdles and/or research and development milestones over a three-year performance period ending in February 2026. Any PSUs earned will vest, if at all, in a single tranche in February 2026 subject to a condition of continuing employment through the end of the performance period. As of June 30, 2023, none of the performance targets are probable of achievement. The fair value of the market-based awards was estimated on the date of grant for accounting purposes using a Monte Carlo simulation model. The fair value of the performance-based awards was based on the closing share price of the Company’s common stock on the accounting grant date.

Stock-Based Compensation

The following table summarizes stock-based compensation expense during the years ended June 30, 2023 (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Stock-based compensation expense by type of award:

 

 

 

 

 

 

 

 

 

 

 

 

Time-based stock options

 

$

6,579

 

 

$

4,493

 

 

$

12,329

 

 

$

8,626

 

Employee stock purchase plan

 

 

100

 

 

 

41

 

 

 

200

 

 

 

83

 

Performance-based restricted stock units

 

 

484

 

 

 

 

 

 

484

 

 

 

 

Total

 

$

7,163

 

 

$

4,534

 

 

$

13,013

 

 

$

8,709

 

 

11


 

The Company recorded stock-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Research and development expenses

 

3,549

 

 

$

2,107

 

 

$

6,505

 

 

$

4,031

 

General and administrative expenses

 

3,614

 

 

 

2,427

 

 

 

6,508

 

 

 

4,678

 

Total

$

7,163

 

 

$

4,534

 

 

$

13,013

 

 

$

8,709

 

 

As of June 30, 2023, total unrecognized compensation cost related to the unvested stock-based options was $62.7 million, which is expected to be recognized over a weighted average period of 2.52 years.

As of June 30, 2023, the total minimum amount of unrecognized compensation cost related to the stock price hurdles for the unvested PSUs was $19.3 million based on the maximum achievement of 200% of the target award, which is expected to be recognized ratably over a weighted average period of 2.67 years. If any research or development milestones become probable of achievement, the Company will recognize incremental stock compensation expense of up to $2.4 million through a cumulative catch up adjustment in the period of change in probability.

7. Commitments and Contingencies

License Agreements

Plexxikon License Agreement

 

In July 2020, the Company obtained an exclusive, sublicensable, worldwide license (the “License Agreement”) to certain patents and other intellectual property rights to research, develop and commercialize bezuclastinib. Under the terms of the License Agreement, the Company is required to pay Plexxikon Inc. (“Plexxikon”) aggregate payments of up to $7.5 million upon the satisfaction of certain clinical milestones and up to $25.0 million upon the satisfaction of certain regulatory milestones. During the second quarter of 2022, as a result of the progression of the PEAK study, the first clinical milestone was achieved, resulting in payment of $2.5 million to Plexxikon in June 2022. As of June 30, 2023, no other milestone payments have been made or are considered probable of occurring.

The Company is also required to pay Plexxikon tiered royalties ranging from a low-single digit percentage to a high-single digit percentage on annual net sales of products. These royalty obligations last on a product-by-product basis and country-by-country basis until the latest of (i) the date on which there is no valid claim of a licensed Plexxikon patent covering a subject product in such country or (ii) the 10th anniversary of the date of the first commercial sale of the product in such country. In addition, if the Company sublicenses the rights under the License Agreement, the Company is required to pay a certain percentage of the sublicense revenue to Plexxikon ranging from mid-double digit percentages to mid-single digit percentages, depending on whether the sublicense is entered into prior to or after certain clinical trial events.

The license agreement will expire on a country-by-country and licensed product-by-licensed product basis until the later of the last to expire of the patents covering such licensed products or services or the 10-year anniversary of the date of first commercial sale of the licensed product in such country. The Company may terminate the license agreement within 30 days after written notice in the event of a material breach. The Company may also terminate the agreement upon written notice in the event of the Company’s bankruptcy, liquidation or insolvency. In addition, the Company has the right to terminate this agreement in its entirety at will upon 90 days’ advance written notice to Plexxikon.


 

 

12


 

Indemnification Agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements that will have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of June 30, 2023 or its consolidated financial statements as of December 31, 2022.

Legal Proceedings

The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings.

8. Net Loss Per Share

Basic and diluted net loss per common share was calculated as follows (in thousands, except share and per share amounts):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(44,076

)

 

$

(34,927

)

 

$

(82,663

)

 

$

(65,561

)

Net loss attributable to common stockholders

$

(44,076

)

 

$

(34,927

)

 

$

(82,663

)

 

$

(65,561

)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic
   and diluted

 

74,753,269

 

 

 

49,388,936

 

 

 

72,755,210

 

 

 

47,259,261

 

Net loss per common share, basic and diluted

$

(0.59

)

 

$

(0.71

)

 

$

(1.14

)

 

$

(1.39

)

 


 

The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be anti-dilutive and would result in a reduction to net loss per share. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated above because including them would have had an anti-dilutive effect:

 

 

 

June 30,

 

 

 

2023

 

 

2022

 

Stock options to purchase common stock

 

 

15,765,126

 

 

 

12,510,099

 

Restricted stock units subject to vesting

 

 

2,500,000

 

 

 

 

Series A Preferred Stock

 

 

19,262,500

 

 

 

21,844,750

 

 

 

37,527,626

 

 

 

34,354,849

 

 

In accordance with ASC Topic 260, Earnings Per Share, the outstanding pre-funded warrants are included in the computation of basic and diluted net loss per share because the exercise price is negligible ($0.01 per share) and they are fully vested and exercisable at any time after the original issuance date.

 

 

13


 

9. Retirement Plan

The Company has a defined-contribution plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The 401(k) Plan allows for discretionary matching contributions of 100% of the first 4% of elective contributions, which vest immediately. Contributions under the plan were approximately $0.3 million and $0.2 million for the three months ended June 30, 2023 and 2022, respectively. Contributions under the plan were approximately $0.6 million and $0.4 million for the six months ended June 30, 2023 and 2022, respectively.

14


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including but not limited to those set forth under the caption “Risk Factors” in this Quarterly Report on Form 10-Q.

Overview

We are a biotechnology company focused on developing precision therapies for genetically defined diseases. Our approach is to design rational precision therapies that treat the underlying cause of disease and improve the lives of patients. Our most advanced program is bezuclastinib, also known as CGT9486, a highly selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. In the vast majority of cases, KIT D816V is responsible for driving Systemic Mastocytosis (“SM”), a serious and rare 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. Bezuclastinib is a highly selective and potent KIT inhibitor with the potential to provide a new treatment option for these patient populations. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases and is initially targeting FGFR2 and ErbB2.

The following is an illustration of the status of our current clinical and pre-clinical programs:


 

Pipeline

img157444438_0.jpg 

Bezuclastinib

In October 2021, we presented preclinical data in a virtual poster at the 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics that identified bezuclastinib as a differentiated, potent and selective KIT mutant inhibitor with unique selectivity for KIT D816V and minimal evidence of brain penetration that avoids targeting PDGFR isoforms. In April 2022, we presented additional preclinical data at the 2022 American Associated for Cancer Research annual meeting (“AACR”) demonstrating that bezuclastinib potently inhibits A loop-mutations, is exquisitely selective against other closely related kinases, and is differentiated by its lack of brain penetration. We also presented preclinical data supporting that bezuclastinib inhibits KIT downstream signaling and drives tumor regressions at clinically achievable doses.

 

15


 

We are continuing the development of bezuclastinib in patients living with Advanced Systemic Mastocytosis (“AdvSM”) and Non-Advanced Systemic Mastocytosis (“Non-AdvSM”). The vast majority of AdvSM and Non-AdvSM patients have a KIT D816V mutation. Patients with AdvSM have a significantly diminished lifespan with a median survival of less than 3.5 years. For patients with Non-AdvSM, there are no available approved therapies, and while their lifespan is not impacted by the disease, these patients suffer from a poor quality of life and new treatment options are badly needed. The FDA has granted orphan drug designation to bezuclastinib for the treatment of Mastocytosis.

APEX is our global, open-label, multi-center, Phase 2 clinical trial in patients with AdvSM evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. In June 2022, we reported positive initial clinical data from the ongoing APEX trial at the 2022 European Hematology Association Annual Congress and we presented updated positive clinical data in an oral presentation at the American Society of Hematology (“ASH”) Annual Meeting in December 2022. In April 2023, we initiated Part 2 of the APEX trial using an optimized formulation of bezuclastinib at 150 mg daily dose. Clinical data from approximately 30 patients from APEX Part 1 is expected to be included in a presentation at a scientific meeting in the second half of 2023. Clinical activity, safety and tolerability of patients dosed in APEX Part 1 remains consistent with results presented at ASH.

SUMMIT is our randomized, double-blind, placebo-controlled, global multi-center Phase 2 clinical trial for patients with Non-AdvSM. The study is designed to evaluate the safety and efficacy of bezuclastinib in patients with moderate to severe Indolent Systemic Mastocytosis or Smoldering Systemic Mastocytosis. Based on the performance of bezuclastinib’s optimized formulation in the PEAK lead-in trial, as well as in a healthy volunteer study, the SUMMIT trial protocol was amended in 2022 to allow for the optimized formulation to be introduced during the dose exploration phase. In March 2023, Cogent received approvals from European regulatory authorities to initiate the SUMMIT trial in patients with Non-AdvSM. We have started activating clinical trial sites across major countries in the European Union. We expect to report initial clinical data in patients with Non-AdvSM in the second half of 2023.

We are also pursuing the development of bezuclastinib in patients living with GIST based on our study of more than 50 advanced solid tumor and GIST patients in a Phase 1/2 clinical trial, with the vast majority of those patients living with advanced GIST. GIST is a disease frequently driven by KIT mutations, and resistance to currently available therapeutics is frequently associated with the emergence of other KIT mutations. Anti-tumor activity for bezuclastinib was observed in both single agent and combination settings, including in combination with sunitinib, an approved treatment option for GIST patients. Clinical data from the Phase 1/2 clinical trial were published in the Journal of American Medical Association and were presented at several scientific conferences, including most recently by Cogent at the 2020 annual Connective Tissue Oncology Society (“CTOS”) meeting, and previously by Plexxikon Inc., a member of the Daiichi Sankyo Group (“Plexxikon”), at the 2018 annual American Society of Clinical Oncology meeting and the 2017 annual CTOS meeting. Within the group of 15 heavily pre-treated GIST patients who received the combination of bezuclastinib and sunitinib, and who had not received prior treatment with bezuclastinib, the confirmed objective response rate was twenty percent, including two partial responses and one complete response, while the estimated median progression free survival (“mPFS”) for this group was twelve months. Four subjects continued to receive bezuclastinib via individual patient INDs beyond the conclusion of the trial.

PEAK is our randomized open-label, global Phase 3 clinical trial designed to evaluate the safety, tolerability, and efficacy of bezuclastinib in combination with sunitinib compared to sunitinib alone in patients with locally advanced, unresectable or metastatic GIST who have received prior treatment with imatinib. The FDA and EMA have granted orphan drug designation to bezuclastinib for the treatment of GIST.

In November 2021, through a partnership with Serán Biosciences, we announced the development of our optimized formulation of bezuclastinib, which was initially used in the PEAK lead-in study. Based on the data from the PEAK lead-in study we have initiated the randomized portion of PEAK using a 600 mg dose of the optimized formulation of bezuclastinib, which in the lead-in portion of the study demonstrated clinical exposure equivalent to the 1,000 mg original formulation used in our GIST Phase 1/2 clinical trial. Initial safety and pharmacokinetic data from the PEAK lead-in study was presented at the CTOS annual meeting in November 2022. In June 2023, we presented positive lead-in data from the on-going Phase 3 PEAK trial of bezuclastinib plus sunitinib at the 2023 annual American Society of Clinical Oncology (“ASCO”). As of the cutoff date of March 29, 2023, the combination of bezuclastinib and sunitinib was generally well-tolerated with an encouraging safety profile. Data were immature to estimate median progression free survival. The data demonstrated 55% Disease Control Rate (“DCR”) in heavily pre-treated GIST patients, including 100% DCR and 17% overall response rate in efficacy evaluable 2nd-line GIST patients.

Worldwide rights to develop and commercialize bezuclastinib are exclusively licensed from Plexxikon. Under the terms of the license agreement, Plexxikon received an upfront payment and is eligible for additional development milestones of up to $7.5 million upon the satisfaction of certain clinical milestones and up to $25.0 million upon the satisfaction of certain regulatory milestones. During the second quarter of 2022, as a result of the progression of the Peak study, the first clinical milestone was achieved, resulting in payment of $2.5 million to Plexxikon in June 2022.

 

16


 

Patents protecting bezuclastinib include composition of matter claims which have been issued in the US and other key territories and provide exclusivity through 2033 and potentially beyond through patent term extensions. In addition, we filed a provisional patent application seeking to protect our optimized formulation of bezuclastinib, which could potentially provide exclusivity through at least 2043.
 

Research programs
 

The Cogent Research Team, based in Boulder, Colorado, is focused on pioneering best-in-class, small molecule therapeutics to expand our pipeline and deliver novel precision therapies for patients living with unmet medical needs. Our research team is building a pipeline of small molecule inhibitors, with our first efforts aimed toward targeting currently undrugged mutations in fibroblast growth factor receptor (“FGFR”). FGFR mutations are well-established oncogenic drivers in multiple diseases, but approved medicines fail to capture the full landscape of FGFR altered tumor types, with FGFR1-mediated hyperphosphatemia serving as the most common dose-limiting toxicity for pan-FGFR inhibitors.

In April 2023, we reported preclinical data at the American Association for Cancer Research (“AACR”) 2023 Annual Meeting providing the first published evidence of a reversible, selective FGFR2 inhibitor with coverage of activating and emerging resistance mutations that spares inhibition of FGFR1. Preclinical data demonstrate a profile that delivers equipotent coverage across both key gatekeeper and molecular brake mutations (V564X, N549X) in FGFR2, while avoiding any evidence of FGFR1-linked hyperphosphatemia at efficacious plasma concentrations. In addition, as a reversible inhibitor, the Cogent program retains enzymatic potency against potential cysteine 491 mutations which are known to emerge as key resistance mutations in patients treated with covalent inhibitors.

Our research team is also advancing a novel, ErbB2 mutant program, which is focused on actionable and underserved mutations in a variety of solid tumor indications. In April 2023, we reported preclinical data at AACR describing a series of novel compounds which potently inhibit several key ErbB2 mutations, including YVMA insertions, while sparing inhibition of EGFR. An exemplar compound from these series demonstrates advantages versus tucatinib, an approved benchmark compound, on tumor growth inhibition in a peripheral ErbB2 L755S driven mutant model, as well as in an ErbB2 driven intracranial model. Recent program advances with a novel chemotype have further improved ErbB2 mutational potency and selectivity, increased estimated brain penetrance to 40% and improved human whole blood stability to nearly 24 hours, suggesting a favorable profile for optimal clinical efficacy.

For both FGFR2 and ErbB2, we see an opportunity to provide a more robust molecular response compared to existing therapies. We have selected our FGFR2 clinical candidate, and we expect to announce our ErbB2 clinical candidate in 2024.

Since our inception in 2014, we have focused significant efforts and financial resources on establishing and protecting our intellectual property portfolio, conducting research and development of our product candidates, manufacturing drug product material for use in preclinical studies and clinical trials, staffing our company, and raising capital. We do not have any products approved for sale and have not generated any revenue from product sales. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Our net losses were $82.7 million for the six months ended June 30, 2023 compared to net losses of $65.6 million for the six months ended June 30, 2022. As of June 30, 2023, we had an accumulated deficit of $493.9 million. We expect to continue to incur significant expenses and operating losses for at least the next several years. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

initiate and increase enrollment for our existing and planned clinical trials for our product candidates;
continue to discover and develop additional product candidates;
acquire or in-license other product candidates and technologies;
maintain, expand, and protect our intellectual property portfolio;
hire additional research, clinical, scientific, and commercial personnel;
establish a commercial manufacturing source and secure supply chain capacity sufficient to provide commercial quantities of any product candidates for which we may obtain regulatory approval;
seek regulatory approvals for any product candidates that successfully complete clinical trials;
establish a sales, marketing, and distribution infrastructure to commercialize any products for which we may obtain regulatory approval; and
add operational, financial, and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.

17


 

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. If we obtain regulatory approval for any of our product candidates and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing, and distribution.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances, and marketing, distribution, or licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of one or more of our product candidates.

Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

As of June 30, 2023, we had cash, cash equivalents and marketable securities of $350.9 million. Based on our current plans, we expect that our current cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into 2026.

Components of Our Results of Operations

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including our drug discovery efforts, and the development of our product candidates, which include:

expenses incurred in connection with the discovery, preclinical and clinical development of our product candidates, including under agreements with third parties, such as consultants, contractors and contract research organizations (“CROs”);
the cost of manufacturing drug products for use in our preclinical studies and clinical trials, including under agreements with third parties, such as consultants, contractors and contract manufacturing organizations (“CMOs”);
employee-related expenses, including salaries, related benefits and stock-based compensation expense for employees engaged in research and development functions;
laboratory supplies and animal care;
facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and insurance; and
payments made under third-party licensing agreements.

We expense research and development costs as incurred. Advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.

Certain of our direct research and development expenses are tracked on a program-by-program basis and consist of costs, such as fees paid to consultants, contractors, CMOs, and CROs in connection with our discovery, preclinical and clinical development activities. We do not allocate employee costs, costs associated with the manufacture of bezuclastinib, costs associated with our discovery efforts, laboratory supplies, and facilities, including depreciation or other indirect costs, to specific product development programs because these costs are deployed across multiple product development programs and, as such, are not separately classified.

 

18


 

Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase substantially in connection with our planned clinical and preclinical development activities in the near term and in the future. At this time, we cannot reasonably estimate or know the nature, timing, and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates. The successful development and commercialization of our product candidates is highly uncertain. This is due to the numerous risks and uncertainties associated with product development and commercialization, including the following:

the timing and progress of our preclinical and clinical development activities;
the number and scope of preclinical and clinical programs we decide to pursue;
the progress of the development efforts of parties with whom we have entered, or may enter, into collaboration arrangements;
our ability to maintain our current research and development programs and to establish new ones;
the enrollment rates in our clinical trials;
our ability to establish new licensing or collaboration arrangements;
the future productivity of the Cogent Research Team in Boulder, CO and its ability to discover new product candidates and build our pipeline;
the successful completion of clinical trials with safety, tolerability, and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;
the receipt of regulatory approvals from applicable regulatory authorities;
the success in establishing and operating a manufacturing facility, or securing manufacturing supply through relationships with third parties;
our ability to obtain and maintain patents, trade secret protection, and regulatory exclusivity, both in the United States and internationally;
our ability to protect our rights in our intellectual property portfolio;
the commercialization of our product candidates, if and when approved;
the acceptance of our product candidates, if approved, by patients, the medical community, and third-party payors;
competition with other products; and
a continued acceptable safety profile of our therapies following approval.

A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval for any of our product candidates.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance, and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, investor and public relations, accounting, and audit services. We anticipate that our general and administrative expenses will increase in the future as a result of the costs associated with the expansion of operations to support our on-going discovery, preclinical and clinical activities.

Interest Income

Interest income consists of interest earned on our cash equivalents and marketable securities balances.

 

19


 

Other Income, Net

Other income consists of miscellaneous income and expense unrelated to our core operations, primarily income from subleasing a portion of our former headquarters facilities.

Change in Fair Value of the CVR liability

This consists of changes in the fair value of the CVR liability.

Income Taxes

Since our inception, we have not recorded any current or deferred tax benefit for the net losses we have incurred in each year or for our research and development tax credits generated, as we believe, based upon the weight of available evidence, that it is more likely than not that our net operating loss carryforwards and tax credits will not be realized. Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31, 2022. We reevaluate the utilization of net operating loss carryforwards and tax credits at each reporting period. As of December 31, 2022, we had U.S. federal and state net operating loss carryforwards of $151.9 million and $65.1 million, respectively, which may be available to offset future taxable income and begin to expire in 2035. Of the federal net operating loss carryforwards at December 31, 2022, $148.7 million is available to be carried forward indefinitely but we are permitted to offset a maximum of 80% of taxable income per year. As of December 31, 2022, we also had U.S. federal and state research and development tax credit carryforwards of $10.7 million and $1.9 million, respectively, which may be available to offset future income tax liabilities and begin to expire in 2040 and 2035, respectively.

Utilization of the U.S. federal and state net operating loss carryforwards and research and development tax credit carryforwards may be subject to annual limitation under Section 382 of the Internal Revenue Code of 1986, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period.

We have recorded a full valuation allowance against our net deferred tax assets at each balance sheet date.

Results of Operations

Comparison of the Three Months Ended June 30, 2023 and 2022

The following table summarizes our results of operations for the three months ended June 30, 2023 and 2022:

 

 

 

Three Months Ended June 30,

 

 

 

 

 

 

2023

 

 

2022

 

 

Change

 

 

 

(in thousands)

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

38,871

 

 

$

29,479

 

 

$

9,392

 

General and administrative

 

 

8,214

 

 

 

6,376

 

 

 

1,838

 

Total operating expenses

 

 

47,085

 

 

 

35,855

 

 

 

11,230

 

Loss from operations

 

 

(47,085

)

 

 

(35,855

)

 

 

(11,230

)

Other income:

 

 

 

 

 

 

 

 

 

Interest income

 

 

2,741

 

 

 

272

 

 

 

2,469

 

Other income, net

 

 

268

 

 

 

656

 

 

 

(388

)

Total other income, net

 

 

3,009

 

 

 

928

 

 

 

2,081

 

Net loss

 

$

(44,076

)

 

$

(34,927

)

 

$

(9,149

)

 

 

20


 

Research and Development Expenses

The following table summarizes our research and development expenses for the three months ended June 30, 2023 and 2022:

 

 

 

Three Months Ended June 30,

 

 

 

 

 

 

2023

 

 

2022

 

 

Change

 

 

 

(in thousands)

 

 

 

 

Direct external research and development expenses:

 

 

 

 

 

 

 

 

 

Bezuclastinib

 

$

17,532

 

$

16,072

 

 

$

1,460

 

Preclinical research and discovery

 

 

5,055

 

 

2,601

 

 

 

2,454

 

Unallocated expenses:

 

 

 

 

 

 

 

 

Personnel related (including stock-based compensation)

 

 

12,556

 

 

8,095

 

 

 

4,461

 

Laboratory supplies, facility related and other

 

 

3,728

 

 

2,711

 

 

 

1,017

 

Total research and development expenses

 

$

38,871

 

 

$

29,479

 

 

$

9,392

 

 

Total research and development expense increased by $9.4 million for the three months ended June 30, 2023 compared to the three months ended June 30, 2022, driven by higher external research and development costs associated with the manufacture and development of bezuclastinib, including costs associated with the APEX, SUMMIT and PEAK trials, and the continued development of our research pipeline. Additionally, there was an increase in unallocated expenses driven by higher personnel costs due to an increase in headcount, including stock-based compensation expense which increased by $1.4 million for the three months ended June 30, 2023 compared to the three months ended June 30, 2022. This increase was further driven by increased lab supplies and other facilities costs to support the Cogent Research Team.

General and Administrative Expenses

General and administrative expenses for the three months ended June 30, 2023 were $8.2 million, compared to $6.4 million for the three months ended June 30, 2022. The increase in general and administrative expenses was primarily due to higher personnel costs driven by an increase in headcount, including stock-based compensation expense which increased by $1.2 million for the three months ended June 30, 2023 compared to the three months ended June 30, 2022.

Interest Income

Interest income for the three months ended June 30, 2023 was $2.7 million, compared to $0.3 million for the three months ended June 30, 2022 . The increase is due to higher average invested balances in cash equivalents and marketable securities.

Other Income, Net

Other income, net for the three months ended June 30, 2023 was $0.3 million compared to $0.7 million for the three months ended June 30, 2022. Other income represents sublease income recognized resulting from the sublease of a portion of our former corporate headquarters space. The decrease in other income, net is driven by the expiration of our former corporate headquarters lease and associated sublease in April 2023.

 

 

21


 

Comparison of the Six Months Ended June 30, 2023 and 2022

The following table summarizes our results of operations for the six months ended June 30, 2023 and 2022:

 

 

 

Six Months Ended June 30,

 

 

 

 

 

 

2023

 

 

2022

 

 

Change

 

 

 

(in thousands)

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

74,909

 

 

$

54,949

 

 

$

19,960

 

General and administrative

 

 

15,413

 

 

 

12,324

 

 

 

3,089

 

Total operating expenses

 

 

90,322

 

 

 

67,273

 

 

 

23,049

 

Loss from operations

 

 

(90,322

)

 

 

(67,273

)

 

 

(23,049

)

Other income:

 

 

 

 

 

 

 

 

 

Interest income

 

 

5,009

 

 

 

379

 

 

 

4,630

 

Other income, net

 

 

950

 

 

 

1,333

 

 

 

(383

)

Change in fair value of CVR liability

 

 

1,700

 

 

 

 

 

 

1,700

 

Total other income, net

 

 

7,659

 

 

 

1,712

 

 

 

5,947

 

Net loss

 

$

(82,663

)

 

$

(65,561

)

 

$

(17,102

)

 

Research and Development Expenses

The following table summarizes our research and development expenses for the six months ended June 30, 2023 and 2022:

 

 

 

Six Months Ended June 30,

 

 

 

 

 

 

2023

 

 

2022

 

 

Change

 

 

 

(in thousands)

 

 

 

 

Direct external research and development expenses:

 

 

 

 

 

 

 

 

 

Bezuclastinib

 

$

33,311

 

$

29,533

 

 

 

3,778

 

Preclinical research and discovery

 

 

9,336

 

 

4,969

 

 

 

4,367

 

Unallocated expenses:

 

 

 

 

 

 

 

 

Personnel related (including stock-based compensation)

 

 

24,629

 

 

15,747

 

 

 

8,882

 

Laboratory supplies, facility related and other

 

 

7,633

 

 

4,700

 

 

 

2,933

 

Total research and development expenses

 

$

74,909

 

 

$

54,949

 

 

$

19,960

 

 

Total research and development expense increased by $20.0 million for the six months ended June 30, 2023 compared to the six months ended June 30, 2022, driven by higher external research and development costs associated with the manufacture and development of bezuclastinib, including costs associated with the APEX, SUMMIT and PEAK trials, and the continued development of our research pipeline. Additionally, there was an increase in unallocated expenses driven by higher personnel costs due to an increase in headcount, including stock-based compensation expense which increased by $2.5 million for the six months ended June 30, 2023 compared to the six months ended June 30, 2022. This increase was further driven by increased lab supplies and other facilities costs to support the Cogent Research Team.

General and Administrative Expenses

General and administrative expenses for the six months ended June 30, 2023 were $15.4 million, compared to $12.3 million for the six months ended June 30, 2022. The increase in general and administrative expenses was primarily due to higher personnel costs driven by an increase in headcount, including stock-based compensation expense which increased by $1.8 million for the six months ended June 30, 2023 compared to the six months ended June 30, 2022.

Interest Income

Interest income for the six months ended June 30, 2023 was $5.0 million, compared to $0.4 million for the six months ended June 30, 2022. The increase is due to higher average invested balances in cash equivalents and marketable securities.

 

22


 

Other Income, Net

Other income, net for the six months ended June 30, 2023 was $1.0 million, compared to $1.3 million for the six months ended June 30, 2022. Other income represents sublease income recognized resulting from the sublease of a portion of our former corporate headquarters space. The decrease in other income, net is driven by the expiration of our former corporate headquarters lease and associated sublease in April 2023.

Change in fair value of CVR Liability

The change in fair value of CVR liability for six months ended June 30, 2023 was $1.7 million. The change in fair value of CVR liability was a result of a decrease in the probability of receiving the milestone payments from Sotio prior to the expiration of the CVR on August 6, 2023.

Liquidity and Capital Resources

Since our inception, we have incurred significant operating losses. We have generated limited revenue to date from funding arrangements with our former collaboration partner. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all. We have historically funded our operations primarily through the public offering and private placement of our securities and consideration received from our collaborative agreements.

On May 6, 2022, we filed a shelf registration statement on Form S-3 with the SEC. The shelf registration statement allows us to sell from time-to-time up to $300.0 million of common stock, preferred stock, debt securities, warrants or units comprised of any combination of these securities, for our own account in one or more offerings. The terms of any offering under the shelf registration statement will be established at the time of such offering and will be described in a prospectus supplement filed with the SEC prior to the completion of any such offering.

Additionally, on May 6, 2022, pursuant to the Form S-3, we entered into a Sales Agreement (the “Sales Agreement”) with Guggenheim Securities, LLC (“Guggenheim Securities”), pursuant to which we may issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to $75.0 million through Guggenheim Securities, as the sales agent. As of June 30, 2023, no shares have been sold under the Sales Agreement.

On June 13, 2022, we completed an underwritten public offering of 17,899,698 shares of our common stock at a public offering price of $8.25 per share (including the exercise in full by the underwriters of their 30-day option to purchase up to 2,730,000 additional shares of common stock) and, in lieu of common stock to certain investors, pre-funded warrants to purchase 3,030,302 shares of our common stock at a purchase price of $8.24 per underlying share. The net proceeds from the offering were approximately $161.9 million, after deducting the underwriting discounts and commissions and estimated offering expenses.

On February 10, 2023, we filed a Form S-3ASR with the SEC (“2023 Shelf Registration”) for the issuance of common stock, preferred stock, warrants, rights, debt securities and units, which became effective immediately upon filing. At the time any of the securities covered by the 2023 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.

In June 2023, we completed an underwritten public offering of 14,375,000 shares of our common stock at a public offering price of $12.00 per share (including the exercise in full by the underwriters of their 30-day option to purchase up to 1,875,000 additional shares of common stock). The net proceeds from the offering were approximately $161.8 million, after deducting the underwriting discounts and commissions and offering expenses.

As of June 30, 2023, we have 105,202,725 shares outstanding on an as-converted basis, which consists of 85,334,165 shares of common stock outstanding, pre-funded warrants that are exercisable for 606,060 shares of common stock, and 77,050 shares of Series A Preferred Stock that are convertible into 19,262,500 shares of common stock.

As of June 30, 2023, we had cash, cash equivalents and marketable securities of $350.9 million, which we believe will be sufficient to fund our operating expenses and capital expenditure requirements into 2026.

23


 

Cash Flows

The following table summarizes our sources and uses of cash for each of the periods presented:

 

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

 

(in thousands)

 

Cash used in operating activities

 

$

(71,583

)

 

$

(54,790

)

Net cash used in investing activities

 

 

(17,777

)

 

 

(1,585

)

Net cash provided by financing activities

 

 

162,536

 

 

 

162,253

 

Net increase in cash, cash equivalents and restricted cash

 

$

73,176

 

 

$

105,878

 

 

Operating Activities

During the six months ended June 30, 2023, operating activities used $71.6 million of cash, primarily resulting from our net loss of $82.7 million and net cash used in changes in our operating assets and liabilities of $0.4 million, partially offset by net noncash charges of $11.5 million. Net cash used in changes in our operating assets and liabilities for the six months ended June 30, 2023 consisted primarily of a $0.7 million increase in prepaid expenses other current assets and a $0.3 million decrease in the operating lease liability, partially offset by a $0.6 million increase in accounts payable and accrued expenses and other current liabilities.

During the six months ended June 30, 2022, operating activities used $54.8 million of cash, primarily resulting from our net loss of $65.6 million, partially offset by net cash provided by changes in our operating assets and liabilities of $0.8 million and by net noncash charges of $9.9 million. Net cash provided by changes in our operating assets and liabilities for the six months ended June 30, 2022 consisted primarily of a $3.2 million increase in accounts payable and accrued expenses and other current liabilities, partially offset by a $1.2 million increase in other assets, a $0.9 million increase in prepaid expenses and other current assets, and a $0.3 million decrease in the operating lease liability.

Investing Activities

During the six months ended June 30, 2023, net cash provided by investing activities was $17.8 million which consisted of purchases of property and equipment and marketable securities, partially offset by maturities and sales of marketable securities.

During the six months ended June 30, 2022, net cash used in investing activities was $1.6 million, which consisted primarily of purchases of property and equipment.

Financing Activities

During the six months ended June 30, 2023, net cash provided by financing activities was $162.5 million, which consisted of $162.0 million in proceeds from the issuance of common stock in an underwritten public offering, net of paid offering costs, proceeds from the issuance of common stock under the Employee Stock Purchase Plan and proceeds from the issuance of common stock upon stock option exercises.

During the six months ended June 30, 2022, net cash provided by financing activities was $162.3 million, which consisted of $162.1 million in proceeds from the issuance of common stock and pre-funded warrants in an underwritten public offering, net of paid offering costs, proceeds from the issuance of common stock under the Employee Stock Purchase Plan and proceeds from the issuance of common stock upon stock option exercises.

 

24


 

Funding Requirements

We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the clinical development of our current and any future product candidates and conduct additional research, development and preclinical activities. The timing and amount of our operating expenditures will depend largely on:

the initiation, progress, timing, and completion of preclinical studies and clinical trials for our current and future potential product candidates;
any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;
adverse results or delays in clinical trials;
our decision to initiate a clinical trial, not to initiate a clinical trial, or to terminate an existing clinical trial;
adverse regulatory decisions, including failure to receive regulatory approval of our product candidates;
changes in laws or regulations applicable to our products, including but not limited to clinical trial requirements for approvals;
adverse developments concerning our manufacturers;
our inability to obtain adequate product supply for any approved product or our inability to do so at acceptable prices;
our inability to establish collaborations, if desired or needed;
our failure to commercialize our product candidates;
additions or departures of key scientific or management personnel; and
unanticipated serious safety concerns related to the use of our product candidates.

Based on our current plans, we believe that our existing cash, cash equivalents and marketable securities of $350.9 million as of June 30, 2023 will enable us to fund our operating expenses and capital expenditure requirements into 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. The Company will require additional funding to complete the critical activities planned to support ongoing research and development programs.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances, and marketing, distribution, or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, existing ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures, or declaring dividends. If we raise additional funds through collaborations, strategic alliances, or marketing, distribution, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce, or terminate our research, product development, or future commercialization efforts, or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

Critical Accounting Estimates

There have been no material changes in our critical accounting policies during the three months ended June 30, 2023, as compared to those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

25


 

Contractual Obligations and Commitments
 

A description of our material cash requirements, including commitments for capital expenditures, is described above and disclosed in Note 7 to our condensed consolidated financial statements
appearing elsewhere in this Quarterly Report.

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.

Emerging Growth Company Status

The Jumpstart Our Business Startups Act of 2012 (“JOBS Act”) permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have irrevocably elected to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards when they are required to be adopted by public companies that are not emerging growth companies.

Based on the aggregate market value of our common stock held by non-affiliates as of June 30, 2023, we believe we will become a “large accelerated filer” and no longer qualify as an emerging growth company or smaller reporting company as of December 31, 2023. Because we believe our emerging growth company and non-accelerated filer status will expire on December 31, 2023, we may be required, pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, to include in our Annual Report on Form 10-K for the year ending December 31, 2023 an attestation report as to the effectiveness of our internal control over financial reporting that is issued by our independent registered public accounting firm. In addition, beginning with our Quarterly Report on Form 10-Q for the quarter ending March 31, 2024, we expect to no longer be permitted to take advantage of the reduced reporting requirements applicable to smaller reporting companies.

26


 

Item 3. Quantitative and Qualitative Disclosures about Market Risk.

We are a smaller reporting company, as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended, for this reporting period and are not required to provide the information required under this item.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and President and our Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2023. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2023, our Chief Executive Officer and our Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

 

No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the three months ended June 30, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

27


 

PART II—OTHER INFORMATION

We are not currently subject to any material legal proceedings. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless of the outcome, litigation can have a material adverse effect on us because of defense and settlement costs, diversion of management resources, and other factors.

Item 1A. Risk Factors.

There have been no material changes from our risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 14, 2023. The risks described in our Form 10-K are not the only risks facing our Company. Additional risk and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

Item 2. Recent Sales of Unregistered Securities and Use of Proceeds

None.

Item 3. Defaults Upon Senior Securities

Not applicable.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None.

28


 

Item 6. Exhibits.

 

Exhibit

Number

 

Description

  10.1#

 

Cogent Biosciences, Inc. Amended and Restated 2018 Stock Option and Incentive Plan (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K (File No. 001-38443) filed on June 7, 2023)

 

 

 

  31.1*

 

Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

  31.2*

 

Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

  32.1*†

 

Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

  32.2*†

 

Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

101.INS

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document.

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

104

 

The cover page for the Company’s Quarterly Report on Form 10-Q has been formatted in Inline XBRL and contained in Exhibit 101

 

# Indicates a management contract or any compensatory plan, contract or arrangement.

* Filed herewith

† The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Cogent Biosciences, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.

29


 

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 thereunto duly authorized.

 

COGENT BIOSCIENCES, INC.

 

 

 

Date: August 8, 2023

By:

/s/ Andrew Robbins

Andrew Robbins

President and Chief Executive Officer

(Principal Executive Officer)

 

 

 

Date: August 8, 2023

By:

/s/ John Green

John Green

Chief Financial Officer

(Principal Accounting and Financial Officer)

 

30


Exhibit 31.1

CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Andrew Robbins, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Cogent Biosciences, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 8, 2023

By:

 

/s/ Andrew Robbins

 

 

 

Andrew Robbins

 

 

 

Chief Executive Officer and President

(Principal Executive Officer)

 


Exhibit 31.2

CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, John Green, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Cogent Biosciences, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 8, 2023

By:

 

/s/ John Green

 

 

 

John Green

 

 

 

Chief Financial Officer

(Principal Accounting and Financial Officer)

 


Exhibit 32.1

 

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of Cogent Biosciences, Inc. (the “Company”) for the period ended June 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Andrew Robbins, President and Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: August 8, 2023

By:

 

/s/ Andrew Robbins

 

 

 

Andrew Robbins

 

 

 

Chief Executive Officer and President

(Principal Executive Officer)

 


Exhibit 32.2

 

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of Cogent Biosciences, Inc. (the “Company”) for the period ended June 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, John Green, Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: August 8, 2023

By:

 

/s/ John Green

 

 

 

John Green

 

 

 

Chief Financial Officer

(Principal Accounting and Financial Officer)

 


v3.23.2
Document and Entity Information - shares
6 Months Ended
Jun. 30, 2023
Aug. 04, 2023
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Jun. 30, 2023  
Document Fiscal Year Focus 2023  
Document Fiscal Period Focus Q2  
Entity Registrant Name Cogent Biosciences, Inc.  
Entity Central Index Key 0001622229  
Current Fiscal Year End Date --12-31  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company true  
Entity Ex Transition Period true  
Entity Common Stock, Shares Outstanding   85,465,249
Entity Shell Company false  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity File Number 001-38443  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 46-5308248  
Entity Address, Address Line One 275 Wyman Street  
Entity Address, Address Line Two 3rd Floor  
Entity Address, City or Town Waltham  
Entity Address, State or Province MA  
Entity Address, Postal Zip Code 02451  
City Area Code (617)  
Local Phone Number 945-5576  
Title of 12(b) Security Common Stock, $0.001 Par Value  
Trading Symbol COGT  
Security Exchange Name NASDAQ  
v3.23.2
Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Current assets:    
Cash and cash equivalents $ 214,317 $ 139,886
Short-term marketable securities 115,082 119,390
Prepaid expenses and other current assets 5,120 4,435
Restricted cash   1,255
Total current assets 334,519 264,966
Long-term marketable securities 21,512  
Operating lease, right-of-use asset 22,468 23,316
Property and equipment, net 9,095 7,783
Other assets 4,775 4,745
Total assets 392,369 300,810
Current liabilities:    
Accounts payable 7,161 5,842
Accrued expenses and other current liabilities 17,419 17,884
CVR liability (Note 3)   1,700
Operating lease liability 1,177 1,423
Total current liabilities 25,757 26,849
Operating lease liability, net of current portion 18,184 18,226
Total liabilities 43,941 45,075
Commitments and contingencies (Note 7)
Stockholders’ equity:    
Common stock, $0.001 par value; 150,000,000 shares authorized; 85,334,165 shares and 69,893,434 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively 85 70
Additional paid-in capital 780,007 601,153
Accumulated other comprehensive loss (97) (104)
Accumulated deficit (493,877) (411,214)
Total stockholders’ equity 348,428 255,735
Total liabilities and stockholders’ equity 392,369 300,810
Series A Convertible Preferred Stock [Member]    
Stockholders’ equity:    
Preferred stock, value $ 62,310 $ 65,830
v3.23.2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Jun. 30, 2023
Dec. 31, 2022
Preferred stock, par value $ 0.001  
Preferred stock, shares authorized 10,000,000  
Preferred stock, shares issued 0  
Preferred stock, shares outstanding 0  
Common stock, Par value $ 0.001 $ 0.001
Common stock, Shares authorized 150,000,000 150,000,000
Common stock, Shares issued 85,334,165 69,893,434
Common stock, Shares outstanding 85,334,165 69,893,434
Series A Convertible Preferred Stock [Member]    
Preferred stock, par value $ 0.001 $ 0.001
Preferred stock, shares authorized 1,000,000 1,000,000
Preferred stock, shares issued 77,050 81,050
Preferred stock, shares outstanding 77,050 81,050
Undesignated Preferred Stock [Member]    
Preferred stock, par value $ 0.001 $ 0.001
Preferred stock, shares authorized 9,000,000 9,000,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
v3.23.2
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Operating expenses:        
Research and development $ 38,871 $ 29,479 $ 74,909 $ 54,949
General and administrative 8,214 6,376 15,413 12,324
Total operating expenses 47,085 35,855 90,322 67,273
Loss from operations (47,085) (35,855) (90,322) (67,273)
Other income:        
Interest income 2,741 272 5,009 379
Other income, net 268 656 950 1,333
Change in fair value of CVR liability     1,700  
Total other income, net 3,009 928 7,659 1,712
Net loss $ (44,076) $ (34,927) $ (82,663) $ (65,561)
Net loss per share attributable to common stockholders, basic $ (0.59) $ (0.71) $ (1.14) $ (1.39)
Net loss per share attributable to common stockholders, diluted $ (0.59) $ (0.71) $ (1.14) $ (1.39)
Weighted average common shares outstanding, basic 74,753,269 49,388,936 72,755,210 47,259,261
Weighted average common shares outstanding, diluted 74,753,269 49,388,936 72,755,210 47,259,261
Comprehensive loss:        
Net loss $ (44,076) $ (34,927) $ (82,663) $ (65,561)
Other comprehensive loss        
Net unrealized gains (losses) on marketable securities (113)   7  
Total other comprehensive loss (113)   7  
Comprehensive loss $ (44,189) $ (34,927) $ (82,656) $ (65,561)
v3.23.2
Condensed Consolidated Statements of Stockholders' Equity - USD ($)
$ in Thousands
Total
Preferred Stock [Member]
Series A Non-Voting Convertible Preferred Stock [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Accumulated Other Comprehensive Income (Loss) [Member]
Accumulated Deficit [Member]
Beginning Balances at Dec. 31, 2021 $ 214,184 $ 85,400 $ 44 $ 399,713   $ (270,973)
Beginning Balances, Shares at Dec. 31, 2021   103,289 43,805,922      
Conversion of Series A non-voting preferred stock into common stock   $ (7,000) $ 2 6,998    
Conversion of Series A non-voting preferred stock into common stock, Shares   (7,955) 1,988,750      
Issuance of common stock to settle CVR liability 129     129    
Issuance of common stock to settle CVR liability, Shares     18,995      
Issuance of common stock for services 9     9    
Issuance of common stock for services, Shares     5,599      
Stock-based compensation expense 4,175     4,175    
Net loss (30,634)         (30,634)
Ending Balances at Mar. 31, 2022 187,863 $ 78,400 $ 46 411,024   (301,607)
Ending Balances, Shares at Mar. 31, 2022   95,334 45,819,266      
Beginning Balances at Dec. 31, 2021 214,184 $ 85,400 $ 44 399,713   (270,973)
Beginning Balances, Shares at Dec. 31, 2021   103,289 43,805,922      
Net loss (65,561)          
Ending Balances at Jun. 30, 2022 319,385 $ 71,400 $ 66 584,453   (336,534)
Ending Balances, Shares at Jun. 30, 2022   87,379 65,707,714      
Beginning Balances at Mar. 31, 2022 187,863 $ 78,400 $ 46 411,024   (301,607)
Beginning Balances, Shares at Mar. 31, 2022   95,334 45,819,266      
Issuance of common stock, net of issuance costs 161,915   $ 18 161,897    
Shares of common stock issued and sold     17,899,698      
Conversion of Series A non-voting preferred stock into common stock   $ (7,000) $ 2 6,998    
Conversion of Series A non-voting preferred stock into common stock, Shares   (7,955) 1,988,750      
Stock-based compensation expense 4,534     4,534    
Net loss (34,927)         (34,927)
Ending Balances at Jun. 30, 2022 319,385 $ 71,400 $ 66 584,453   (336,534)
Ending Balances, Shares at Jun. 30, 2022   87,379 65,707,714      
Beginning Balances at Dec. 31, 2022 255,735 $ 65,830 $ 70 601,153 $ (104) (411,214)
Beginning Balances, Shares at Dec. 31, 2022   81,050 69,893,434      
Conversion of Series A non-voting preferred stock into common stock   $ (3,520) $ 1 3,519    
Conversion of Series A non-voting preferred stock into common stock, Shares   (4,000) 1,000,000      
Issuance of common stock under Employee Stock Purchase Plan 313     313    
Issuance of common stock under Employee Stock Purchase Plan, Shares     39,228      
Issuance of common stock upon exercise of stock options 132     132    
Issuance of common stock upon exercise of stock options, Shares     14,128      
Unrealized gains (losses) on marketable securities 120       120  
Stock-based compensation expense 5,850     5,850    
Net loss (38,587)         (38,587)
Ending Balances at Mar. 31, 2023 223,563 $ 62,310 $ 71 610,967 16 (449,801)
Ending Balances, Shares at Mar. 31, 2023   77,050 70,946,790      
Beginning Balances at Dec. 31, 2022 255,735 $ 65,830 $ 70 601,153 (104) (411,214)
Beginning Balances, Shares at Dec. 31, 2022   81,050 69,893,434      
Net loss (82,663)          
Ending Balances at Jun. 30, 2023 348,428 $ 62,310 $ 85 780,007 (97) (493,877)
Ending Balances, Shares at Jun. 30, 2023   77,050 85,334,165      
Beginning Balances at Mar. 31, 2023 223,563 $ 62,310 $ 71 610,967 16 (449,801)
Beginning Balances, Shares at Mar. 31, 2023   77,050 70,946,790      
Issuance of common stock, net of issuance costs 161,789   $ 14 161,775    
Shares of common stock issued and sold     14,375,000      
Issuance of common stock upon exercise of stock options 102     102    
Issuance of common stock upon exercise of stock options, Shares     12,375      
Unrealized gains (losses) on marketable securities (113)       (113)  
Stock-based compensation expense 7,163     7,163    
Net loss (44,076)         (44,076)
Ending Balances at Jun. 30, 2023 $ 348,428 $ 62,310 $ 85 $ 780,007 $ (97) $ (493,877)
Ending Balances, Shares at Jun. 30, 2023   77,050 85,334,165      
v3.23.2
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($)
$ in Millions
3 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Underwritten Public Offering [Member]    
Issuance cost $ 10.7 $ 10.8
v3.23.2
Condensed Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Cash flows from operating activities:    
Net loss $ (82,663) $ (65,561)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization expense 1,091 166
Stock-based compensation expense 13,013 8,709
Amortization of operating leases, right-of-use assets 848 1,064
Change in fair value of CVR liability (1,700)  
Net amortization (accretion) of premiums (discounts) on marketable securities (1,780)  
Changes in operating assets and liabilities:    
Prepaid expenses and other current assets (685) (909)
Other assets (30) (1,168)
Accounts payable 1,319 9
Accrued expenses and other current liabilities (708) 3,173
Operating lease liability (288) (273)
Net cash used in operating activities (71,583) (54,790)
Cash flows from investing activities:    
Purchases of property and equipment (2,360) (1,585)
Purchases of marketable securities (185,417)  
Maturities and sales of marketable securities 170,000  
Net cash used in investing activities (17,777) (1,585)
Cash flows from financing activities:    
Proceeds from issuance of shares of common stock, net of offering costs of $10.7 million 161,989  
Proceeds from issuance of shares of common stock and pre-funded warrants, net of offering costs of $10.8 million   162,115
Proceeds from issuance of stock from employee stock purchase plan 313 129
Proceeds from issuance of common stock upon stock option exercises 234 9
Net cash provided by financing activities 162,536 162,253
Net increase in cash, cash equivalents and restricted cash 73,176 105,878
Cash, cash equivalents and restricted cash at beginning of period 141,141 220,939
Cash, cash equivalents and restricted cash at end of period 214,317 326,817
Supplemental disclosure of cash flow information:    
Right-of-use assets obtained in exchange for new operating lease liabilities   25,184
Supplemental disclosure of noncash investing and financing information:    
Offering costs included in accounts payable and accrued expenses 200 200
Property & equipment included in accounts payable and accrued expenses 43 466
Conversion of Series A Convertible Preferred stock into common shares $ 3,520 $ 14,000
v3.23.2
Consolidated Statements of Cash Flows (Parenthetical) - USD ($)
$ in Millions
6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Common Stock Underwritten Public Offering [Member]    
Offering/Issuance costs $ 10.7 $ 10.8
v3.23.2
Nature of the Business and Basis of Presentation
6 Months Ended
Jun. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Nature of the Business and Basis of Presentation Nature of the Business and Basis of Presentation

Cogent Biosciences, Inc. (“Cogent” or the “Company”) is a biotechnology company focused on developing precision therapies for genetically defined diseases. Cogent’s approach is to design rational precision therapies that treat the underlying cause of disease and improve the lives of patients. Cogent’s most advanced program is bezuclastinib, also known as CGT9486, a highly selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. In the vast majority of cases, KIT D816V is responsible for driving Systemic Mastocytosis (“SM”), a serious and rare 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. Bezuclastinib is a highly selective and potent KIT inhibitor with the potential to provide a new treatment option for these patient populations. In addition to bezuclastinib, the Company’s research team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases, and is initially targeting FGFR2 and ErbB2.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.

The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has incurred recurring losses since inception, including a net loss of $82.7 million for the six months ended June 30, 2023. As of June 30, 2023, the Company had an accumulated deficit of $493.9 million. The Company expects to continue to generate operating losses in the foreseeable future. As of the issuance date of the interim condensed consolidated financial statements, the Company expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months from issuance of the condensed consolidated financial statements.

The Company expects that it will continue to incur significant expenses in connection with its ongoing business activities. The Company will need to seek additional funding through equity offerings, debt financings, collaborations, licensing arrangements or other marketing and distribution arrangements, partnerships, joint ventures, combinations or divestitures of one or more of its assets or businesses. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into collaborative arrangements or divest its assets. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. Arrangements with collaborators or others may require the Company to relinquish rights to certain of its technologies or product candidates. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate its research and development programs or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations.

The Company’s condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).

v3.23.2
Summary of Significant Accounting Policies
6 Months Ended
Jun. 30, 2023
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Unaudited Interim Financial Information

The consolidated balance sheet at December 31, 2022 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of June 30, 2023 and for the three and six months ended June 30, 2023 and 2022 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. 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, 2022 included in the Company’s Annual Report on Form 10-K on file with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2023 and results of operations for the three and six months ended June 30, 2023 and 2022 and cash flows for the six months ended June 30, 2023 and 2022 have been made. The Company’s results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Mono, Inc. and Kiq Bio LLC. All intercompany accounts and transactions have been eliminated.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual of research and development expenses, the valuation of the CVR liability and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions.

Marketable Securities

The Company’s marketable securities, consisting of debt securities, are classified as available-for-sale. Available-for-sale marketable debt securities are carried at fair value with the unrealized gains and losses included in other comprehensive income (loss) as a component of stockholders’ equity until realized. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other income (expense). The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, a loss is recognized in net income, and if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss).

v3.23.2
Marketable Securities and Fair Value of Financial Assets and Liabilities
6 Months Ended
Jun. 30, 2023
Fair Value Disclosures [Abstract]  
Marketable Securities and Fair Value of Financial Assets and Liabilities

3. Marketable Securities and Fair Value of Financial Assets and Liabilities

The following table summarizes the Company’s marketable securities (in thousands):

 

 

 

June 30, 2023

 

 

 

Amortized
Cost

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Fair
Value

 

U.S. Treasury bills and notes (due within one year)

 

$

115,135

 

 

$

8

 

 

$

(61

)

 

$

115,082

 

U.S. Treasury bills and notes (due after one through five years)

 

 

21,556

 

 

 

 

 

 

(44

)

 

 

21,512

 

 

$

136,691

 

 

$

8

 

 

$

(105

)

 

$

136,594

 

 

 

 

December 31, 2022

 

 

 

Amortized
Cost

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Fair
Value

 

U.S. Treasury bills and notes (due within one year)

 

$

119,494

 

 

$

 

 

$

(104

)

 

$

119,390

 

 

 

$

119,494

 

 

$

 

 

$

(104

)

 

$

119,390

 

As of June 30, 2023, the Company held twenty-seven securities that were in an unrealized loss position. The aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months as of June 30, 2023 was $92.1 million and there were no securities held by the Company in an unrealized loss position for more than twelve months. As of December 31, 2022, the Company held seven securities that were in an unrealized loss position. The aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months as of December 31, 2022 was $99.5 million and there were no securities held by the Company in an unrealized loss position for more than twelve months. The Company has the intent and ability to hold such securities until recovery. As a result, the Company did not record any charges for impairments for its marketable debt securities for the three and six months ended June 30, 2023 and for the year ended December 31, 2022.

The following tables present the Company’s fair value hierarchy for its financial assets and liabilities, which are measured at fair value on a recurring basis (in thousands):

 

 

 

Fair Value Measurements at June 30, 2023 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

171,485

 

 

$

 

 

$

 

 

$

171,485

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury bills and notes

 

$

 

 

$

136,594

 

 

$

 

 

$

136,594

 

Total assets

 

$

171,485

 

 

$

136,594

 

 

$

 

 

$

308,079

 

 

 

 

Fair Value Measurements at December 31, 2022 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

108,829

 

 

$

 

 

$

 

 

$

108,829

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury bills and notes

 

$

 

 

$

119,390

 

 

$

 

 

$

119,390

 

Total assets

 

$

108,829

 

 

$

119,390

 

 

$

 

 

$

228,219

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

CVR liability

 

$

 

 

$

 

 

$

1,700

 

 

$

1,700

 

Total liabilities

 

$

 

 

$

 

 

$

1,700

 

 

$

1,700

 

 

Money market funds were valued using quoted prices in active markets, which represent a Level 1 measurement in the fair value hierarchy. U.S. Treasury bills and notes were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy.

On July 6, 2020, the Company issued a non-transferrable contingent value right (“CVR”), which was distributed to stockholders of record as of the close of business on July 6, 2020, and prior to the issuance of any shares to acquire Kiq Bio LLC (“Kiq”) (the “Kiq Acquisition”) or sold to the Private Investment in Public Equity (“PIPE”) investors. Holders of the CVR are entitled to receive common shares and/or cash payments from proceeds received by the Company, if any, related to the disposition of its legacy cell therapy assets for a period of three years from July 2020. In accordance with the terms of the CVR agreement, the payment to CVR holders will be made in shares or cash, depending on the timing of the receipt of the sales proceeds by the Company. For sales proceeds received by the Company prior to December 31, 2020, CVR holders were entitled to receive payment in the form of common shares of the Company. For sales proceeds received by the Company after December 31, 2020 and prior to July 2023, CVR holders are entitled to receive payment in cash.

The Company classifies the CVR as a liability on its condensed consolidated balance sheet. The fair value of the CVR liability was determined using the probability weighted discounted cash flow method to estimate future cash flows associated with the sale of the legacy cell therapy assets, including the Bolt-on Chimeric Receptor (“BOXR”) technology and Autologous Cell Therapy Industrial Automation technology (collectively, the “BOXR Platform”), Antibody-Coupled T cell Receptor technology and other fixed assets based on assumptions at the date of the CVR issuance and each subsequent quarterly period end, less certain permitted deductions. For sales proceeds received by the Company prior to December 31, 2020, the number of common shares to be received by CVR holders was determined by dividing the proceeds received by the Company by the closing price of the Company’s common stock on July 6, 2020 of $8.80. The closing price of the Company’s common stock at each measurement date through February 2021 was used to determine the fair value of the share payments included in the CVR liability. The liability measured at the date of CVR issuance was recorded as a common stock dividend, returning capital to the legacy stockholders of record as of the close of business on July 6, 2020. Changes in fair value of the liability are recognized as a component of other income (expense) in the condensed consolidated statement of operations and comprehensive loss. The CVR liability was valued based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy.

On August 28, 2020, the Company sold its assets, rights and interests relating to its BOXR Platform, to Sotio. Pursuant to the BOXR Platform Purchase Agreement, Sotio has agreed to pay the Company total cash consideration of up to $11.5 million, consisting of an upfront payment of $8.1 million and potential milestone payments of up to $3.4 million in the aggregate upon the achievement of certain milestones related to the issuance of Specified Claims (as described in the BOXR Platform Purchase Agreement) by the U.S. Patent and Trademark Office and the European Patent Office. The upfront payment was received in 2020. In 2020, the Company also sold additional fixed assets used in the legacy business. Both transactions triggered payment to the CVR holders. In November 2020, the Company issued 707,938 shares of common stock in partial settlement of the CVR liability. In February 2021, the Company issued an additional 212,429 shares of common stock and paid $0.1 million in partial settlement of the CVR liability. Any settlement of the remaining CVR liability will be a cash settlement.

In the fourth quarter of 2022, the Company updated the probability weighted discounted cash flow assumptions to reflect the then current probability of receiving the milestone payments from Sotio prior to the expiration of the CVR. Based on the Company’s assessment of the available information, this update resulted in a decrease in the probability of receiving the milestone payment prior to the expiration of the CVR and a corresponding decrease in the CVR liability of $1.4 million was recognized as a component of other income (expense) in 2022. Based on the Company’s assessment of the information available through the issuance date of the financial statements, the Company recorded an additional decrease in fair value of the liability of $1.7 million in the first quarter of 2023, reducing the liability to zero as the probability of additional CVR payments occurring prior to the expiration of CVR term is remote. The CVRs expired on August 6, 2023 and no further payments will be made to CVR holders.

The following table sets forth a summary of the changes in the fair value of the Company’s CVR liability (in thousands):

Balance at December 31, 2021

 

$

3,060

 

Change in fair value

 

 

(1,360

)

Balance at December 31, 2022

 

$

1,700

 

Change in fair value

 

 

(1,700

)

Balance at June 30, 2023

 

$

 

 

During the three and six months ended June 30, 2023 and 2022, there were no transfers between Level 1, Level 2 and Level 3.

v3.23.2
Accrued Expenses and Other Current Liabilities
6 Months Ended
Jun. 30, 2023
Payables and Accruals [Abstract]  
Accrued Expenses and Other Current Liabilities

4. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

 

 

 

June 30,
2023

 

 

December 31,
2022

 

Accrued employee compensation and benefits

 

$

4,757

 

 

$

6,063

 

Accrued external research and development expense

 

 

8,380

 

 

 

5,898

 

Accrued external manufacturing costs

 

 

1,624

 

 

 

3,741

 

Accrued professional and consulting services

 

 

2,162

 

 

 

1,778

 

Other

 

 

496

 

 

 

404

 

Total

 

$

17,419

 

 

$

17,884

 

v3.23.2
Preferred Stock, Series A Non-Voting Convertible Preferred Stock and Common Stock
6 Months Ended
Jun. 30, 2023
Equity [Abstract]  
Preferred Stock, Series A Non-Voting Convertible Preferred Stock and Common Stock

5. Preferred Stock, Series A Non-Voting Convertible Preferred Stock and Common Stock

The Company’s authorized capital stock consists of 150,000,000 shares of common stock, par value $0.001 per share, and 10,000,000 shares of preferred stock, par value $0.001 per share, 1,000,000 of which are designated as Series A Preferred Stock and 9,000,000 of which shares of preferred stock are undesignated.

Series A Non-Voting Convertible Preferred Stock

On July 6, 2020, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series A Non-Voting Convertible Preferred Stock (“Series A Preferred Stock”) with the Secretary of State of the State of Delaware (the “Certificate of Designation”) in connection with the Kiq Acquisition and the PIPE. The Certificate of Designation provides for the issuance of shares of Series A Preferred Stock, par value $0.001 per share.

Holders of Series A Preferred Stock are entitled to receive dividends on shares of Series A Preferred Stock equal, on an as-if-converted-to-common-stock basis, and in the same form as dividends actually paid on shares of the common stock. Except as otherwise required by law, the Series A Preferred Stock does not have voting rights. However, as long as any shares of Series A Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock, (b) alter or amend the Certificate of Designation, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A Preferred Stock, (d) increase the number of authorized shares of Series A Preferred Stock, (e) prior to the stockholder approval of the Conversion Proposal or at any time while at least 40% of the originally issued Series A Preferred Stock remains issued and outstanding, consummate a Fundamental Transaction (as defined in the Certificate of Designation) or (f) enter into any agreement with respect to any of the foregoing. The Series A Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company.

Each share of Series A Preferred Stock is convertible at any time at the option of the holder thereof, into 250 shares of common stock, subject to certain limitations, including that a holder of Series A Preferred Stock is prohibited from converting shares of Series A Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.9% and 19.9%) of the total number of shares of common stock issued and outstanding immediately after giving effect to such conversion. Cumulatively, through June 30, 2023, 86,275 shares of Series A Preferred Stock, or 52.8% of the issued Series A Preferred Stock, have been converted into 21,568,750 shares of common stock. The 77,050 shares of Series A Preferred Stock outstanding as of June 30, 2023 are convertible into 19,262,500 shares of common stock.

No other classes of preferred stock have been designated and no other preferred shares have been issued or are outstanding as of June 30, 2023.

 

Common Stock

Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are not entitled to receive dividends, unless declared by the board of directors. In the event of the Company’s liquidation, dissolution or winding up, holders of the Company’s common stock will be entitled to share ratably in all assets remaining after payment of all debts and other liabilities and any liquidation preference of any outstanding preferred stock. The shares to be issued by us in this offering will be, when issued and paid for, validly issued, fully paid and non-assessable.

On May 6, 2022, the Company filed a shelf registration statement on Form S-3 with the SEC. The shelf registration statement allows the Company to sell from time-to-time up to $300.0 million of common stock, preferred stock, debt securities, warrants or units comprised of any combination of these securities, for its own account in one or more offerings. The terms of any offering under the shelf registration statement will be established at the time of such offering and will be described in a prospectus supplement filed with the SEC prior to the completion of any such offering.

Additionally, on May 6, 2022, pursuant to the Form S-3, the Company entered into a Sales Agreement (the “Sales Agreement”) with Guggenheim Securities, LLC (“Guggenheim Securities”), pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $75.0 million through Guggenheim Securities, as the sales agent. As of June 30, 2023, no shares have been sold under the Sales Agreement.

On June 13, 2022, the Company completed an underwritten public offering of 17,899,698 shares of its common stock at a public offering price of $8.25 per share (including the exercise in full by the underwriters of their 30-day option to purchase up to 2,730,000 additional shares of common stock) and, in lieu of common stock to certain investors, pre-funded warrants to purchase 3,030,302 shares of its common stock at a purchase price of $8.24 per underlying share. The net proceeds from the offering were approximately $161.9 million, after deducting the underwriting discounts and commissions of $10.4 million and offering expenses of $0.4 million.

Each pre-funded warrant entitles the holder to purchase shares of common stock at an exercise price of $0.01 per share and is exercisable at any time beginning on the date of issuance. These warrants were recorded as a component of stockholders’ equity within additional paid-in capital. Per the terms of the warrant agreement, a holder of the outstanding warrant is not entitled to exercise any portion of the pre-funded warrant if, upon giving effect to such exercise, would cause the aggregate number of shares of common stock beneficially owned by such holder (together with its affiliates and any other person whose beneficial ownership of common stock would be aggregated with the holder) to exceed 9.99% of the total number of then issued and outstanding shares of common stock, as such percentage ownership is determined in accordance with the terms of the pre-funded warrant and subject to such holder’s rights under the pre-funded warrant to increase or decrease such percentage to any other percentage not in excess of 19.99% upon at least 61 days’ prior notice from such holder. As of June 30, 2023, 2,424,242 pre-funded warrants have been exercised and 606,060 pre-funded warrants remain outstanding.

On February 10, 2023, the Company filed a Form S-3ASR with the SEC (“2023 Shelf Registration”) for the issuance of common stock, preferred stock, warrants, rights, debt securities and units, which became effective immediately upon filing. At the time any of the securities covered by the 2023 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.

In June 2023, the Company completed an underwritten public offering of 14,375,000 shares of its common stock at a public offering price of $12.00 per share (including the exercise in full by the underwriters of their 30-day option to purchase up to 1,875,000 additional shares of common stock). The net proceeds from the offering were approximately $161.8 million, after deducting the underwriting discounts and commissions of $10.3 million and offering expenses of $0.4 million.

v3.23.2
Stock-Based Compensation
6 Months Ended
Jun. 30, 2023
Share-Based Payment Arrangement [Abstract]  
Stock-Based Compensation

6. Stock-Based Compensation

2018 Stock Option and Incentive Plan

The Company’s 2018 Stock Option and Incentive Plan, (the “2018 Plan”), which became effective on March 27, 2018, provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards, cash-based awards and dividend equivalent rights. The number of shares initially reserved for issuance under the 2018 Plan was 700,180. Additionally, the shares of common stock that remained available for issuance under the previously outstanding 2015 Stock Incentive Plan (the “2015 Plan”) became available under the 2018 Plan. The number of shares reserved for the 2018 Plan automatically increases on each January 1 by 4% of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or a lesser number of shares determined by the Company’s board of directors. Additionally, at the Company’s 2021 annual stockholder meeting, the Company’s stockholders approved the amendment and restatement of the 2018 Stock Plan to increase the number of shares of common stock issuable under the 2018 Plan by 6,000,000 shares.

 

The number of authorized shares reserved for issuance under the 2018 Plan was increased by 2,795,737 shares effective as of January 1, 2023. On June 7, 2023, at the Company’s 2023 annual stockholder meeting, the Company’s stockholders approved the amendment and restatement of the 2018 Plan to increase the number of shares of common stock issuable under the 2018 Plan by an additional 6,000,000 shares (the “2023 Pool Increase”). The shares of common stock underlying any awards that are forfeited, canceled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, repurchased or are otherwise terminated by the Company under the 2018 Plan or the 2015 Plan will be added back to the shares of common stock available for issuance under the 2018 Plan. As of June 30, 2023, 4,022,464 shares of common stock remain available for issuance under the 2018 Plan.

Inducement Plan

On October 22, 2020, the board of directors adopted the Cogent Biosciences, Inc. 2020 Inducement Plan (the “Inducement Plan”). The board of directors also adopted a form of non-qualified stock option agreement for use with the Inducement Plan. A total of 3,750,000 shares of common stock have been reserved for issuance under the Inducement Plan, subject to adjustment for stock dividends, stock splits, or other changes in Cogent’s common stock or capital structure. On November 5, 2020, the Company filed a Registration Statement on Form S-8 related to the 3,750,000 shares of its common stock reserved for issuance under the Inducement Plan. As of June 30, 2023, 677,995 shares of common stock remain available for issuance under the Inducement Plan.

2018 Employee Stock Purchase Plan

The Company’s 2018 Employee Stock Purchase Plan (the “ESPP”) became effective on March 28, 2018, at which time a total of 78,500 shares of common stock were reserved for issuance. In addition, the number of shares of common stock that may be issued under the ESPP automatically increases on each January 1 through January 1, 2027, by the least of (i) 125,000 shares of common stock, (ii) 1% of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or (iii) such lesser number of shares as determined by the ESPP administrator. The number of authorized shares reserved for issuance under the ESPP was increased by 125,000 shares effective as of January 1, 2023. As of June 30, 2023, 490,040 shares remain available for issuance under the ESPP. In July 2023, 46,650 shares were issued to employees under the ESPP.

Performance-based restricted stock units

In February 2023, the Board approved grants in aggregate of up to 2,500,000 performance-based restricted stock units (“PSUs”) under the 2018 Plan, which grants were subject to forfeiture in the event that the Company’s stockholders did not approve the 2023 Pool Increase. On June 7, 2023, stockholders approved the 2023 Pool Increase and a grant date was established for accounting purposes for these PSUs in accordance with ASC 718 Compensation- Stock Compensation. An award holder can generally receive between 0% and 200% of the target award based on achievement of specified stock price hurdles and/or research and development milestones over a three-year performance period ending in February 2026. Any PSUs earned will vest, if at all, in a single tranche in February 2026 subject to a condition of continuing employment through the end of the performance period. As of June 30, 2023, none of the performance targets are probable of achievement. The fair value of the market-based awards was estimated on the date of grant for accounting purposes using a Monte Carlo simulation model. The fair value of the performance-based awards was based on the closing share price of the Company’s common stock on the accounting grant date.

Stock-Based Compensation

The following table summarizes stock-based compensation expense during the years ended June 30, 2023 (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Stock-based compensation expense by type of award:

 

 

 

 

 

 

 

 

 

 

 

 

Time-based stock options

 

$

6,579

 

 

$

4,493

 

 

$

12,329

 

 

$

8,626

 

Employee stock purchase plan

 

 

100

 

 

 

41

 

 

 

200

 

 

 

83

 

Performance-based restricted stock units

 

 

484

 

 

 

 

 

 

484

 

 

 

 

Total

 

$

7,163

 

 

$

4,534

 

 

$

13,013

 

 

$

8,709

 

 

The Company recorded stock-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Research and development expenses

 

3,549

 

 

$

2,107

 

 

$

6,505

 

 

$

4,031

 

General and administrative expenses

 

3,614

 

 

 

2,427

 

 

 

6,508

 

 

 

4,678

 

Total

$

7,163

 

 

$

4,534

 

 

$

13,013

 

 

$

8,709

 

 

As of June 30, 2023, total unrecognized compensation cost related to the unvested stock-based options was $62.7 million, which is expected to be recognized over a weighted average period of 2.52 years.

As of June 30, 2023, the total minimum amount of unrecognized compensation cost related to the stock price hurdles for the unvested PSUs was $19.3 million based on the maximum achievement of 200% of the target award, which is expected to be recognized ratably over a weighted average period of 2.67 years. If any research or development milestones become probable of achievement, the Company will recognize incremental stock compensation expense of up to $2.4 million through a cumulative catch up adjustment in the period of change in probability.

v3.23.2
Commitments and Contingencies
6 Months Ended
Jun. 30, 2023
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

7. Commitments and Contingencies

License Agreements

Plexxikon License Agreement

 

In July 2020, the Company obtained an exclusive, sublicensable, worldwide license (the “License Agreement”) to certain patents and other intellectual property rights to research, develop and commercialize bezuclastinib. Under the terms of the License Agreement, the Company is required to pay Plexxikon Inc. (“Plexxikon”) aggregate payments of up to $7.5 million upon the satisfaction of certain clinical milestones and up to $25.0 million upon the satisfaction of certain regulatory milestones. During the second quarter of 2022, as a result of the progression of the PEAK study, the first clinical milestone was achieved, resulting in payment of $2.5 million to Plexxikon in June 2022. As of June 30, 2023, no other milestone payments have been made or are considered probable of occurring.

The Company is also required to pay Plexxikon tiered royalties ranging from a low-single digit percentage to a high-single digit percentage on annual net sales of products. These royalty obligations last on a product-by-product basis and country-by-country basis until the latest of (i) the date on which there is no valid claim of a licensed Plexxikon patent covering a subject product in such country or (ii) the 10th anniversary of the date of the first commercial sale of the product in such country. In addition, if the Company sublicenses the rights under the License Agreement, the Company is required to pay a certain percentage of the sublicense revenue to Plexxikon ranging from mid-double digit percentages to mid-single digit percentages, depending on whether the sublicense is entered into prior to or after certain clinical trial events.

The license agreement will expire on a country-by-country and licensed product-by-licensed product basis until the later of the last to expire of the patents covering such licensed products or services or the 10-year anniversary of the date of first commercial sale of the licensed product in such country. The Company may terminate the license agreement within 30 days after written notice in the event of a material breach. The Company may also terminate the agreement upon written notice in the event of the Company’s bankruptcy, liquidation or insolvency. In addition, the Company has the right to terminate this agreement in its entirety at will upon 90 days’ advance written notice to Plexxikon.


 

 

Indemnification Agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements that will have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of June 30, 2023 or its consolidated financial statements as of December 31, 2022.

Legal Proceedings

The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings.

v3.23.2
Net Loss Per Share
6 Months Ended
Jun. 30, 2023
Earnings Per Share [Abstract]  
Net Loss Per Share

8. Net Loss Per Share

Basic and diluted net loss per common share was calculated as follows (in thousands, except share and per share amounts):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(44,076

)

 

$

(34,927

)

 

$

(82,663

)

 

$

(65,561

)

Net loss attributable to common stockholders

$

(44,076

)

 

$

(34,927

)

 

$

(82,663

)

 

$

(65,561

)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic
   and diluted

 

74,753,269

 

 

 

49,388,936

 

 

 

72,755,210

 

 

 

47,259,261

 

Net loss per common share, basic and diluted

$

(0.59

)

 

$

(0.71

)

 

$

(1.14

)

 

$

(1.39

)

 


 

The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be anti-dilutive and would result in a reduction to net loss per share. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated above because including them would have had an anti-dilutive effect:

 

 

 

June 30,

 

 

 

2023

 

 

2022

 

Stock options to purchase common stock

 

 

15,765,126

 

 

 

12,510,099

 

Restricted stock units subject to vesting

 

 

2,500,000

 

 

 

 

Series A Preferred Stock

 

 

19,262,500

 

 

 

21,844,750

 

 

 

37,527,626

 

 

 

34,354,849

 

 

In accordance with ASC Topic 260, Earnings Per Share, the outstanding pre-funded warrants are included in the computation of basic and diluted net loss per share because the exercise price is negligible ($0.01 per share) and they are fully vested and exercisable at any time after the original issuance date.

v3.23.2
Retirement Plan
6 Months Ended
Jun. 30, 2023
Retirement Benefits [Abstract]  
Retirement Plan

9. Retirement Plan

The Company has a defined-contribution plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The 401(k) Plan allows for discretionary matching contributions of 100% of the first 4% of elective contributions, which vest immediately. Contributions under the plan were approximately $0.3 million and $0.2 million for the three months ended June 30, 2023 and 2022, respectively. Contributions under the plan were approximately $0.6 million and $0.4 million for the six months ended June 30, 2023 and 2022, respectively.

v3.23.2
Summary of Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2023
Accounting Policies [Abstract]  
Unaudited Interim Financial Information

Unaudited Interim Financial Information

The consolidated balance sheet at December 31, 2022 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of June 30, 2023 and for the three and six months ended June 30, 2023 and 2022 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. 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, 2022 included in the Company’s Annual Report on Form 10-K on file with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2023 and results of operations for the three and six months ended June 30, 2023 and 2022 and cash flows for the six months ended June 30, 2023 and 2022 have been made. The Company’s results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.

Principles of Consolidation

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Mono, Inc. and Kiq Bio LLC. All intercompany accounts and transactions have been eliminated.

Use of Estimates

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual of research and development expenses, the valuation of the CVR liability and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions.

Marketable Securities

Marketable Securities

The Company’s marketable securities, consisting of debt securities, are classified as available-for-sale. Available-for-sale marketable debt securities are carried at fair value with the unrealized gains and losses included in other comprehensive income (loss) as a component of stockholders’ equity until realized. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other income (expense). The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, a loss is recognized in net income, and if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss).

v3.23.2
Marketable Securities and Fair Value of Financial Assets and Liabilities (Tables)
6 Months Ended
Jun. 30, 2023
Fair Value Disclosures [Abstract]  
Summary of Marketable Securities

The following table summarizes the Company’s marketable securities (in thousands):

 

 

 

June 30, 2023

 

 

 

Amortized
Cost

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Fair
Value

 

U.S. Treasury bills and notes (due within one year)

 

$

115,135

 

 

$

8

 

 

$

(61

)

 

$

115,082

 

U.S. Treasury bills and notes (due after one through five years)

 

 

21,556

 

 

 

 

 

 

(44

)

 

 

21,512

 

 

$

136,691

 

 

$

8

 

 

$

(105

)

 

$

136,594

 

 

 

 

December 31, 2022

 

 

 

Amortized
Cost

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Fair
Value

 

U.S. Treasury bills and notes (due within one year)

 

$

119,494

 

 

$

 

 

$

(104

)

 

$

119,390

 

 

 

$

119,494

 

 

$

 

 

$

(104

)

 

$

119,390

 

Schedule of Financial Assets and Liabilities at Fair Value on Recurring Basis

The following tables present the Company’s fair value hierarchy for its financial assets and liabilities, which are measured at fair value on a recurring basis (in thousands):

 

 

 

Fair Value Measurements at June 30, 2023 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

171,485

 

 

$

 

 

$

 

 

$

171,485

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury bills and notes

 

$

 

 

$

136,594

 

 

$

 

 

$

136,594

 

Total assets

 

$

171,485

 

 

$

136,594

 

 

$

 

 

$

308,079

 

 

 

 

Fair Value Measurements at December 31, 2022 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

108,829

 

 

$

 

 

$

 

 

$

108,829

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury bills and notes

 

$

 

 

$

119,390

 

 

$

 

 

$

119,390

 

Total assets

 

$

108,829

 

 

$

119,390

 

 

$

 

 

$

228,219

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

CVR liability

 

$

 

 

$

 

 

$

1,700

 

 

$

1,700

 

Total liabilities

 

$

 

 

$

 

 

$

1,700

 

 

$

1,700

 

Summary of Changes in the Fair Value of Company's CVR Liability

The following table sets forth a summary of the changes in the fair value of the Company’s CVR liability (in thousands):

Balance at December 31, 2021

 

$

3,060

 

Change in fair value

 

 

(1,360

)

Balance at December 31, 2022

 

$

1,700

 

Change in fair value

 

 

(1,700

)

Balance at June 30, 2023

 

$

 

v3.23.2
Accrued Expenses and Other Current Liabilities (Tables)
6 Months Ended
Jun. 30, 2023
Payables and Accruals [Abstract]  
Schedule of Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

 

 

 

June 30,
2023

 

 

December 31,
2022

 

Accrued employee compensation and benefits

 

$

4,757

 

 

$

6,063

 

Accrued external research and development expense

 

 

8,380

 

 

 

5,898

 

Accrued external manufacturing costs

 

 

1,624

 

 

 

3,741

 

Accrued professional and consulting services

 

 

2,162

 

 

 

1,778

 

Other

 

 

496

 

 

 

404

 

Total

 

$

17,419

 

 

$

17,884

 

v3.23.2
Stock-Based Compensation (Tables)
6 Months Ended
Jun. 30, 2023
Share-Based Payment Arrangement [Abstract]  
Schedule of Stock-based Compensation Expense by Type of Award

The following table summarizes stock-based compensation expense during the years ended June 30, 2023 (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Stock-based compensation expense by type of award:

 

 

 

 

 

 

 

 

 

 

 

 

Time-based stock options

 

$

6,579

 

 

$

4,493

 

 

$

12,329

 

 

$

8,626

 

Employee stock purchase plan

 

 

100

 

 

 

41

 

 

 

200

 

 

 

83

 

Performance-based restricted stock units

 

 

484

 

 

 

 

 

 

484

 

 

 

 

Total

 

$

7,163

 

 

$

4,534

 

 

$

13,013

 

 

$

8,709

 

 

Schedule of Stock Based Compensation Expense

The Company recorded stock-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Research and development expenses

 

3,549

 

 

$

2,107

 

 

$

6,505

 

 

$

4,031

 

General and administrative expenses

 

3,614

 

 

 

2,427

 

 

 

6,508

 

 

 

4,678

 

Total

$

7,163

 

 

$

4,534

 

 

$

13,013

 

 

$

8,709

 

 

v3.23.2
Net Loss per Share (Tables)
6 Months Ended
Jun. 30, 2023
Earnings Per Share [Abstract]  
Schedule of Earnings Per Share Basic and Diluted

Basic and diluted net loss per common share was calculated as follows (in thousands, except share and per share amounts):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(44,076

)

 

$

(34,927

)

 

$

(82,663

)

 

$

(65,561

)

Net loss attributable to common stockholders

$

(44,076

)

 

$

(34,927

)

 

$

(82,663

)

 

$

(65,561

)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic
   and diluted

 

74,753,269

 

 

 

49,388,936

 

 

 

72,755,210

 

 

 

47,259,261

 

Net loss per common share, basic and diluted

$

(0.59

)

 

$

(0.71

)

 

$

(1.14

)

 

$

(1.39

)

Summary of Potential Dilutive Securities

The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be anti-dilutive and would result in a reduction to net loss per share. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated above because including them would have had an anti-dilutive effect:

 

 

 

June 30,

 

 

 

2023

 

 

2022

 

Stock options to purchase common stock

 

 

15,765,126

 

 

 

12,510,099

 

Restricted stock units subject to vesting

 

 

2,500,000

 

 

 

 

Series A Preferred Stock

 

 

19,262,500

 

 

 

21,844,750

 

 

 

37,527,626

 

 

 

34,354,849

 

v3.23.2
Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Mar. 31, 2023
Jun. 30, 2022
Mar. 31, 2022
Jun. 30, 2023
Jun. 30, 2022
Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]              
Net loss $ (44,076) $ (38,587) $ (34,927) $ (30,634) $ (82,663) $ (65,561)  
Accumulated deficit $ (493,877)       $ (493,877)   $ (411,214)
v3.23.2
Marketable Securities and Fair Value of Financial Assets and Liabilities - Summary of Marketable Securities (Details) - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Marketable Securities, Amortized Cost $ 136,691 $ 119,494
Marketable Securities, Gross Unrealized Gains 8  
Marketable Securities, Gross Unrealized Losses (105) (104)
Marketable Securities, Fair Value 136,594 119,390
U.S. Treasury Bills and Notes (Due within One Year) [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Marketable Securities, Amortized Cost 115,135 119,494
Marketable Securities, Gross Unrealized Gains 8  
Marketable Securities, Gross Unrealized Losses (61) (104)
Marketable Securities, Fair Value 115,082 $ 119,390
U.S. Treasury Bills and Notes (Due After One Through Five Years) [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Marketable Securities, Amortized Cost 21,556  
Marketable Securities, Gross Unrealized Losses (44)  
Marketable Securities, Fair Value $ 21,512  
v3.23.2
Marketable Securities and Fair Value of Financial Assets and Liabilities - Schedule of Financial Assets and Liabilities at Fair Value on Recurring Basis (Detail) - Recurring Basis [Member] - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Assets:    
Total assets $ 308,079 $ 228,219
Liabilities:    
CVR liability   1,700
Total liabilities   1,700
Level 1 [Member]    
Assets:    
Total assets 171,485 108,829
Level 2 [Member]    
Assets:    
Total assets 136,594 119,390
Level 3 [Member]    
Liabilities:    
CVR liability   1,700
Total liabilities   1,700
Money Market Funds [Member]    
Assets:    
Cash equivalents 171,485 108,829
Money Market Funds [Member] | Level 1 [Member]    
Assets:    
Cash equivalents 171,485 108,829
U.S. Treasury Bills and Notes [Member]    
Assets:    
Marketable Securities 136,594 119,390
U.S. Treasury Bills and Notes [Member] | Level 2 [Member]    
Assets:    
Marketable Securities $ 136,594 $ 119,390
v3.23.2
Marketable Securities and Fair Value of Financial Assets and Liabilities - Additional Information (Detail)
1 Months Ended 3 Months Ended 6 Months Ended 12 Months Ended
Aug. 06, 2023
Feb. 28, 2021
USD ($)
shares
Nov. 30, 2020
shares
Jun. 30, 2023
USD ($)
Security
Mar. 31, 2023
USD ($)
Jun. 30, 2023
USD ($)
Security
Dec. 31, 2022
USD ($)
Security
Jun. 30, 2022
USD ($)
Aug. 28, 2020
USD ($)
Jul. 06, 2020
$ / shares
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items]                    
Closing price of stock | $ / shares                   $ 8.80
Fair value asset, transfers between Level 1, Level 2 and Level 3, amount       $ 0   $ 0   $ 0    
Number of held securities in an unrealized loss position | Security       27   27 7      
Unrealized loss possition less than 12 months       $ 92,100,000   $ 92,100,000 $ 99,500,000      
Unrealized loss position more than 12 months       0   0 0      
Marketable debt securities, charges for credit-related impairments       $ 0   0 0      
Subsequent Event [Member]                    
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items]                    
CVR expired date Aug. 06, 2023                  
SOTIO [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BOXR Platform [Member]                    
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items]                    
Disposal group, not discontinued operation, upfront payment                 $ 8,100,000  
Maximum [Member] | SOTIO [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BOXR Platform [Member]                    
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items]                    
Disposal group, not discontinued operation, cash consideration                 11,500,000  
Disposal group, not discontinued operation, potential milestone payments upon achievement of specified claims issuance                 $ 3,400,000  
CVR Liability [Member]                    
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items]                    
CVR liability, term                   3 years
Issuance of common stock | shares   212,429 707,938              
Payments of probable reduction         $ 0          
Partial settlement   $ 100,000                
Decrease in fair value         $ 1,700,000 $ 1,700,000 $ 1,360,000      
v3.23.2
Marketable Securities and Fair Value of Financial Assets and Liabilities - Summary of Changes in the Fair Value of Company's CVR Liability (Detail) - CVR Liability [Member] - USD ($)
$ in Thousands
1 Months Ended 3 Months Ended 6 Months Ended 12 Months Ended
Feb. 28, 2021
Mar. 31, 2023
Jun. 30, 2023
Dec. 31, 2022
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items]        
Beginning balance   $ 1,700 $ 1,700 $ 3,060
Change in fair value   $ (1,700) $ (1,700) $ (1,360)
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]     Change In Fair Value Of Contingent Value Right Liability Change In Fair Value Of Contingent Value Right Liability
CVR settlement $ (100)      
Ending balance     $ 0 $ 1,700
v3.23.2
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Payables and Accruals [Abstract]    
Accrued employee compensation and benefits $ 4,757 $ 6,063
Accrued external research and development expense 8,380 5,898
Accrued external manufacturing costs 1,624 3,741
Accrued professional and consulting services 2,162 1,778
Other 496 404
Total $ 17,419 $ 17,884
v3.23.2
Preferred Stock, Series A Non-Voting Convertible Preferred Stock and Common Stock - Additional Information (Detail) - USD ($)
1 Months Ended 3 Months Ended 6 Months Ended 36 Months Ended
Jun. 13, 2022
May 06, 2022
Jun. 30, 2023
Jun. 30, 2023
Mar. 31, 2023
Jun. 30, 2022
Mar. 31, 2022
Jun. 30, 2023
Jun. 30, 2023
Dec. 31, 2022
Class Of Stock [Line Items]                    
Common stock, Shares authorized     150,000,000 150,000,000       150,000,000 150,000,000 150,000,000
Common stock, Par value     $ 0.001 $ 0.001       $ 0.001 $ 0.001 $ 0.001
Preferred stock, par value     $ 0.001 $ 0.001       $ 0.001 $ 0.001  
Preferred stock, shares authorized     10,000,000 10,000,000       10,000,000 10,000,000  
Preferred stock, shares outstanding     0 0       0 0  
Preferred stock, shares issued     0 0       0 0  
Proceeds from issuance of common stock to LPC               $ 161,989,000    
Pre-funded warrants, purchase price per share     $ 0.01 $ 0.01       $ 0.01 $ 0.01  
Underwritten Public Offering [Member]                    
Class Of Stock [Line Items]                    
Beneficial ownership limitation percentage for conversion of common stock issued and outstanding 9.99%                  
Shares of common stock issued and sold 17,899,698   14,375,000              
Exercise of stock options additional shares of common stock 2,730,000   1,875,000              
Stock offering price, per share $ 8.25   $ 12.00 $ 12.00       $ 12.00 $ 12.00  
Proceeds from issuance of common stock to LPC $ 161,900,000   $ 161,800,000              
Underwriting discounts and commissions expenses 10,400,000   10,300,000              
Offering expenses $ 400,000   $ 400,000              
Pre-funded warrants, shares 3,030,302                  
Pre-funded warrants exercised     2,424,242 2,424,242       2,424,242 2,424,242  
Pre-funded warrants remain outstanding     606,060 606,060       606,060 606,060  
Underwriters exercise period option 30 days   30 days              
Guggenheim Securities, LLC [Member]                    
Class Of Stock [Line Items]                    
Shares of common stock issued and sold               0    
Maximum [Member]                    
Class Of Stock [Line Items]                    
Proceeds from issuance of equity and debt financing   $ 300,000,000.0                
Maximum [Member] | Underwritten Public Offering [Member]                    
Class Of Stock [Line Items]                    
Beneficial ownership limitation percentage for conversion of common stock issued and outstanding 19.99%                  
Maximum [Member] | Guggenheim Securities, LLC [Member]                    
Class Of Stock [Line Items]                    
Stock offering cost   $ 75,000,000.0                
Common Stock [Member]                    
Class Of Stock [Line Items]                    
Conversion of preferred stock into common stock, Shares         1,000,000 1,988,750 1,988,750   21,568,750  
Common stock voting right               Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders.    
Shares of common stock issued and sold       14,375,000   17,899,698        
Exercise of stock options additional shares of common stock       12,375 14,128          
Pre-funded warrants, purchase price per share $ 0.01                  
Common Stock [Member] | Underwritten Public Offering [Member]                    
Class Of Stock [Line Items]                    
Pre-funded warrants, purchase price per share $ 8.24                  
Series A Preferred Stock [Member]                    
Class Of Stock [Line Items]                    
Preferred stock, par value     $ 0.001 $ 0.001       $ 0.001 $ 0.001  
Minimum percentage of originally issued shares remain issued and outstanding     40.00% 40.00%       40.00% 40.00%  
Convertible preferred stock, common stock issuable upon conversion     250 250       250 250  
Percentage of preferred stock issued     52.80% 52.80%       52.80% 52.80%  
Cumulative amount of shares conversion                 86,275  
Series A Preferred Stock [Member] | Minimum [Member]                    
Class Of Stock [Line Items]                    
Beneficial ownership limitation percentage for conversion of common stock issued and outstanding     4.90% 4.90%       4.90% 4.90%  
Series A Preferred Stock [Member] | Maximum [Member]                    
Class Of Stock [Line Items]                    
Beneficial ownership limitation percentage for conversion of common stock issued and outstanding     19.90% 19.90%       19.90% 19.90%  
Series A Convertible Preferred Stock [Member]                    
Class Of Stock [Line Items]                    
Preferred stock, par value     $ 0.001 $ 0.001       $ 0.001 $ 0.001 $ 0.001
Preferred stock, shares authorized     1,000,000 1,000,000       1,000,000 1,000,000 1,000,000
Preferred stock, shares outstanding     77,050 77,050       77,050 77,050 81,050
Common stock issued upon conversion of preferred stock     19,262,500 19,262,500       19,262,500 19,262,500  
Preferred stock, shares issued     77,050 77,050       77,050 77,050 81,050
Undesignated Preferred Stock [Member]                    
Class Of Stock [Line Items]                    
Preferred stock, par value     $ 0.001 $ 0.001       $ 0.001 $ 0.001 $ 0.001
Preferred stock, shares authorized     9,000,000 9,000,000       9,000,000 9,000,000 9,000,000
Preferred stock, shares outstanding     0 0       0 0 0
Preferred stock, shares issued     0 0       0 0 0
v3.23.2
Stock-Based Compensation - Additional Information (Detail) - USD ($)
$ in Thousands
1 Months Ended 6 Months Ended
Jun. 07, 2023
Jan. 01, 2023
Mar. 28, 2018
Mar. 27, 2018
Jul. 31, 2023
Feb. 28, 2023
Jun. 30, 2023
Jun. 30, 2022
Nov. 05, 2020
Oct. 22, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                    
Stock-based compensation expense             $ 13,013 $ 8,709    
Unrecognized compensation expenses, recognition period             2 years 8 months 1 day      
Maximum [Member]                    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                    
Incremental stock compensation expense             $ 2,400      
2020 Inducement Plan [Member]                    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                    
Shares available for issuance             677,995      
Shares reserved for future issuance                 3,750,000 3,750,000
Stock Option [Member]                    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                    
Unrecognized compensation cost             $ 62,700      
Unrecognized compensation expenses, recognition period             2 years 6 months 7 days      
Unvested PSUs [Member]                    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                    
Unrecognized compensation cost             $ 19,300      
Percentage of Share Based Compensation Nonvested Awards Stock Maximum Achievement             200.00%      
2018 Stock Option and Incentive Plan [Member]                    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                    
Number of increases in authorized shares       700,180            
Percentage applied to the outstanding shares as annual increase in the number of shares authorized for issuance       4.00%            
Increased in authorized shares reserved for issuance 6,000,000 2,795,737   6,000,000            
Shares available for issuance             4,022,464      
Expiration period           3 years        
2018 Stock Option and Incentive Plan [Member] | Minimum [Member]                    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                    
Percentage of vesting of award           0.00%        
2018 Stock Option and Incentive Plan [Member] | Maximum [Member]                    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                    
Number of shares grants           2,500,000        
Percentage of vesting of award           200.00%        
2018 Employee Stock Purchase Plan [Member]                    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                    
Increased in authorized shares reserved for issuance   125,000                
Shares available for issuance             490,040      
Shares reserved for future issuance     78,500              
2018 Employee Stock Purchase Plan [Member] | Subsequent Event [Member]                    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                    
Number of shares grants         46,650          
2018 Employee Stock Purchase Plan [Member] | Maximum [Member]                    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                    
Number of increases in authorized shares     125,000              
Percentage of shares of common stock available for issuance     1.00%              
v3.23.2
Stock-Based Compensation - Schedule of Stock-based Compensation Expense by Type of Award (Detail) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Share-Based Payment Arrangement, Expense $ 7,163 $ 4,534 $ 13,013 $ 8,709
Employee Stock [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Share-Based Payment Arrangement, Expense 100 41 200 83
Time Based Stock Options [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Share-Based Payment Arrangement, Expense 6,579 $ 4,493 12,329 $ 8,626
Performance-Based Restricted Stock Units [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Share-Based Payment Arrangement, Expense $ 484   $ 484  
v3.23.2
Stock-Based Compensation - Schedule of Stock Based Compensation Expense (Detail) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Stock-based compensation expense $ 7,163 $ 4,534 $ 13,013 $ 8,709
Research and Development Expenses [Member]        
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Stock-based compensation expense 3,549 2,107 6,505 4,031
General and Administrative Expenses [Member]        
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Stock-based compensation expense $ 3,614 $ 2,427 $ 6,508 $ 4,678
v3.23.2
Commitments and Contingencies - Additional Information (Detail) - Plexxikon License Agreement [Member] - USD ($)
1 Months Ended 6 Months Ended
Jul. 30, 2020
Jun. 30, 2023
Jun. 30, 2022
Commitments And Contingencies Disclosure [Line Items]      
Clinical milestone achieved, triggering payment     $ 2,500,000
Other milestone payments   $ 0  
License agreement expiration terms   The license agreement will expire on a country-by-country and licensed product-by-licensed product basis until the later of the last to expire of the patents covering such licensed products or services or the 10-year anniversary of the date of first commercial sale of the licensed product in such country. The Company may terminate the license agreement within 30 days after written notice in the event of a material breach. The Company may also terminate the agreement upon written notice in the event of the Company’s bankruptcy, liquidation or insolvency. In addition, the Company has the right to terminate this agreement in its entirety at will upon 90 days’ advance written notice to Plexxikon.  
Maximum [Member]      
Commitments And Contingencies Disclosure [Line Items]      
Aggregate payments received upon satisfaction of clinical milestones $ 7,500,000    
Aggregate payments received $ 25,000,000.0    
v3.23.2
Net Loss Per Share - Schedule of Earnings Per Share Basic and Diluted (Detail) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Mar. 31, 2023
Jun. 30, 2022
Mar. 31, 2022
Jun. 30, 2023
Jun. 30, 2022
Earnings Per Share [Abstract]            
Net loss $ (44,076) $ (38,587) $ (34,927) $ (30,634) $ (82,663) $ (65,561)
Net loss attributable to common stockholders $ (44,076)   $ (34,927)   $ (82,663) $ (65,561)
Weighted average common shares outstanding, basic 74,753,269   49,388,936   72,755,210 47,259,261
Weighted average common shares outstanding, diluted 74,753,269   49,388,936   72,755,210 47,259,261
Net loss per common share, basic $ (0.59)   $ (0.71)   $ (1.14) $ (1.39)
Net loss per common share, diluted $ (0.59)   $ (0.71)   $ (1.14) $ (1.39)
v3.23.2
Net Loss Per Share - Summary of Potential Dilutive Securities (Detail) - shares
6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Potential dilutive securities excluded from computation of diluted net loss per common share 37,527,626 34,354,849
Stock Options to Purchase Common Stock [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Potential dilutive securities excluded from computation of diluted net loss per common share 15,765,126 12,510,099
Restricted Stock Units Subject to Vesting [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Potential dilutive securities excluded from computation of diluted net loss per common share 2,500,000  
Series A Preferred Stock [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Potential dilutive securities excluded from computation of diluted net loss per common share 19,262,500 21,844,750
v3.23.2
Net Loss Per Share - Additional Information (Details)
Jun. 30, 2023
$ / shares
Earnings Per Share [Abstract]  
Pre-funded warrants, exercise price $ 0.01
v3.23.2
Retirement Plan - Additional Information (Detail) - USD ($)
$ in Millions
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Defined Contribution Plan Disclosure [Line Items]        
Defined contribution plan, employer matching contribution percentage of match     100.00%  
Defined contribution plan, matching amount $ 0.3 $ 0.2 $ 0.6 $ 0.4
Maximum [Member]        
Defined Contribution Plan Disclosure [Line Items]        
Defined contribution plan, employer matching contribution percent     4.00%  

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