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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: 001-39247

 

ENLIVEN THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

81-1523849

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

6200 Lookout Road

Boulder, CO

80301

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (720) 647-8519

 

Not applicable

(Former name, former address, and former fiscal year, 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 per share

 

ELVN

 

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, 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 1, 2023, the registrant had 41,151,111 shares of common stock, $0.001 par value per share, outstanding.

 

 

 


 

Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

3

Condensed Consolidated Balance Sheets

3

Condensed Consolidated Statements of Operations and Comprehensive Loss

4

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

5

Condensed Consolidated Statements of Cash Flows

6

Notes to Unaudited Condensed Consolidated Financial Statements

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

23

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

34

Item 4.

Controls and Procedures

35

 

 

 

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

36

Item 1A.

Risk Factors

36

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

95

Item 3.

Defaults Upon Senior Securities

95

Item 4.

Mine Safety Disclosures

95

Item 5.

Other Information

95

Item 6.

Exhibits

97

SIGNATURES

98

 

i


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this quarterly report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this quarterly report on Form 10-Q include, but are not limited to, statements about:

 

the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;
our ability to utilize our proprietary drug discovery platform to develop a pipeline of product candidates to address unmet needs in cancer;
the timing, progress and results of clinical trials for ELVN-001 from our BCR-ABL (as defined below) program and ELVN-002 from our HER2 (as defined below) program, and other product candidates we have and may in the future develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials will become available, and research and development programs;
the timing, scope and likelihood of regulatory filings and approvals, including timing of INDs (as defined below) and final U.S. Food and Drug Administration (“FDA”) approval of ELVN-001 from our BCR-ABL program and ELVN-002 from our HER2 program and any other future product candidates;
the timing, scope or likelihood of foreign regulatory filings and approvals;
our ability to develop and advance current product candidates and programs into, and successfully complete, clinical trials;
our manufacturing, commercialization, and marketing capabilities and strategy;
plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy;
the need to hire additional personnel and our ability to attract and retain such personnel;
the size of the market opportunity for our product candidates, including estimates of the number of patients who suffer from the diseases we are targeting;
expectations regarding the approval and use of our product candidates in combination with other drugs;
our ability to secure drug product for combination studies;
expectations regarding potential for accelerated approval or other expedited regulatory designation;
our competitive position and the success of competing therapies that are or may become available;
estimates of the number of patients that we will enroll in our clinical trials;
the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of our product candidates;
our ability to obtain and maintain regulatory approval of our product candidates and our expectations regarding particular lines of therapy;
plans relating to the further development of our product candidates, including additional indications we may pursue;
existing regulations and regulatory developments in the United States, Europe and other jurisdictions;
expectations regarding the impact of health epidemics or other outbreaks, including the COVID-19 pandemic, on our business;
our expectations regarding the impact of instability in the banking and financial services sector and other macroeconomic trends;

1


 

our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering ELVN-001 from our BCR-ABL program and ELVN-002 from our HER2 program, and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;
our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for clinical trials;
our relationships with patient advocacy groups, key opinion leaders, regulators, the research community and payors;
our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;
the pricing and reimbursement of ELVN-001 in our BCR-ABL program and ELVN-002 from our HER2 program, and other product candidates we may develop, if approved;
the rate and degree of market acceptance and clinical utility of ELVN-001 from our BCR-ABL program and ELVN-002 from our HER2 program, and other product candidates we may develop;
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
our expectations regarding sales of our common stock made pursuant to the Sales Agreement (as defined below);
our financial performance;
the period over which we estimate our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operating expenses and capital expenditure requirements;
our ability to utilize our net operating loss carryforwards and tax credit carryforwards (“NOLs”);
the impact of laws and regulations; and
expectations regarding the period during which we will qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012 and a smaller reporting company under the Exchange Act (as defined below).

 

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. 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 the section titled “Risk Factors” and elsewhere in this quarterly report on Form 10-Q. 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. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.

 

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this quarterly report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.

2


 

Part I – FINANCIAL INFORMATION

 

Item 1. Condensed Consolidated Financial Statements (Unaudited)

 

ENLIVEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(in thousands, except share and per share amounts)

 

 

 

As of

 

 

As of

 

 

June 30, 2023

 

 

December 31, 2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

      Cash and cash equivalents

 

$

125,715

 

 

$

75,536

 

      Marketable securities

 

 

152,150

 

 

 

 

      Prepaid expenses and other current assets

 

 

5,310

 

 

 

2,217

 

Total current assets

 

 

283,175

 

 

 

77,753

 

Property and equipment, net

 

 

867

 

 

 

890

 

Operating lease right-of-use assets

 

 

475

 

 

 

626

 

Deferred offering costs

 

 

524

 

 

 

3,975

 

Restricted cash

 

 

54

 

 

 

54

 

Other long-term assets

 

 

3,406

 

 

 

 

Total assets

 

$

288,501

 

 

$

83,298

 

Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

      Accounts payable

 

$

2,843

 

 

$

3,438

 

      Accrued expenses and other current liabilities

 

 

6,304

 

 

 

6,277

 

Total current liabilities

 

 

9,147

 

 

 

9,715

 

Long-term liabilities

 

 

360

 

 

 

659

 

Total liabilities

 

 

9,507

 

 

 

10,374

 

Commitments and contingencies (Note 9):

 

 

 

 

 

 

Convertible preferred stock, par value $0.0001; authorized shares - none and 61,730,064 at June 30, 2023 and December 31, 2022, respectively; issued and outstanding shares - none and 61,730,064 at June 30, 2023 and December 31, 2022, respectively; liquidation preference - $0 and $140,520 at June 30, 2023 and December 31, 2022, respectively

 

 

 

 

 

149,749

 

Stockholders' equity (deficit):

 

 

 

 

 

 

Preferred stock, par value $0.001; authorized shares - 10,000,000 and none at June 30, 2023 and December 31, 2022, respectively; issued and outstanding shares - none

 

 

 

 

 

 

Common stock, par value $0.001 and $0.0001 at June 30, 2023 and December 31, 2022, respectively; authorized shares - 100,000,000 and 26,264,364 at June 30, 2023 and December 31, 2022, respectively; issued and outstanding shares - 41,151,111 and 3,570,019 at June 30, 2023 and December 31, 2022, respectively

 

 

41

 

 

 

1

 

      Additional paid-in capital

 

 

393,373

 

 

 

6,038

 

      Accumulated other comprehensive loss

 

 

(111

)

 

 

 

      Accumulated deficit

 

 

(114,309

)

 

 

(82,864

)

Total stockholders’ equity (deficit)

 

 

278,994

 

 

 

(76,825

)

Total liabilities, convertible preferred stock and stockholders' equity (deficit)

 

$

288,501

 

 

$

83,298

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

3


 

ENLIVEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

15,183

 

 

$

7,937

 

 

$

27,063

 

 

$

14,996

 

General and administrative

 

 

4,951

 

 

 

1,079

 

 

 

9,489

 

 

 

2,698

 

Total operating expenses

 

 

20,134

 

 

 

9,016

 

 

 

36,552

 

 

 

17,694

 

Loss from operations

 

 

(20,134

)

 

 

(9,016

)

 

 

(36,552

)

 

 

(17,694

)

Other income (expense), net

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

3,413

 

 

 

127

 

 

 

5,107

 

 

 

136

 

Total other income (expense), net

 

 

3,413

 

 

 

127

 

 

 

5,107

 

 

 

136

 

Net loss

 

 

(16,721

)

 

 

(8,889

)

 

 

(31,445

)

 

 

(17,558

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Net unrealized losses on marketable securities

 

 

(111

)

 

 

 

 

 

(111

)

 

 

 

Comprehensive loss

 

$

(16,832

)

 

$

(8,889

)

 

$

(31,556

)

 

$

(17,558

)

Net loss per share, basic and diluted

 

$

(0.41

)

 

$

(2.86

)

 

$

(1.05

)

 

$

(5.87

)

Weighted-average shares outstanding, basic and diluted

 

 

40,961,024

 

 

 

3,103,974

 

 

 

29,862,182

 

 

 

2,991,004

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

4


 

ENLIVEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

(Unaudited)

(in thousands, except share amounts)

 

 

 

Convertible
Preferred Stock

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Deficit

 

Balance - January 1, 2022

 

 

61,730,064

 

 

$

149,749

 

 

 

 

3,435,014

 

 

$

1

 

 

$

2,314

 

 

$

 

 

$

(45,202

)

 

$

(42,887

)

Exercise of common stock options

 

 

 

 

 

 

 

 

 

122,475

 

 

 

 

 

 

228

 

 

 

 

 

 

 

 

 

228

 

Vesting of restricted stock and stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

64

 

 

 

 

 

 

 

 

 

64

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

654

 

 

 

 

 

 

 

 

 

654

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,669

)

 

 

(8,669

)

Balance - March 31, 2022

 

 

61,730,064

 

 

$

149,749

 

 

 

 

3,557,489

 

 

$

1

 

 

$

3,260

 

 

$

 

 

$

(53,871

)

 

$

(50,610

)

Exercise of common stock options

 

 

 

 

 

 

 

 

 

1,062

 

 

 

 

 

 

5

 

 

 

 

 

 

 

 

 

5

 

Vesting of restricted stock and stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

80

 

 

 

 

 

 

 

 

 

80

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

701

 

 

 

 

 

 

 

 

 

701

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,889

)

 

 

(8,889

)

Balance - June 30, 2022

 

 

61,730,064

 

 

$

149,749

 

 

 

 

3,558,551

 

 

$

1

 

 

$

4,046

 

 

$

 

 

$

(62,760

)

 

$

(58,713

)

 

 

 

Convertible
Preferred Stock

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity (Deficit)

 

Balance - January 1, 2023

 

 

61,730,064

 

 

$

149,749

 

 

 

 

3,570,019

 

 

$

1

 

 

$

6,038

 

 

$

 

 

$

(82,864

)

 

$

(76,825

)

Exercise of common stock options

 

 

 

 

 

 

 

 

 

55,599

 

 

 

 

 

 

140

 

 

 

 

 

 

 

 

 

140

 

Vesting of restricted stock and stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

73

 

 

 

 

 

 

 

 

 

73

 

Conversion of convertible preferred stock to common
   stock in connection with the Merger

 

 

(61,730,064

)

 

 

(149,749

)

 

 

 

18,216,847

 

 

 

18

 

 

 

149,731

 

 

 

 

 

 

 

 

 

149,749

 

Issuance of common stock in the Financing Transaction,
   net of issuance costs of $
4,955

 

 

 

 

 

 

 

 

 

12,638,636

 

 

 

13

 

 

 

159,531

 

 

 

 

 

 

 

 

 

159,544

 

Issuance of common stock to former stockholders of
   Imara Inc. in connection with the Merger

 

 

 

 

 

 

 

 

 

6,625,176

 

 

 

7

 

 

 

80,234

 

 

 

 

 

 

 

 

 

80,241

 

Adjustment for change in common stock par value in
   connection with the Merger

 

 

 

 

 

 

 

 

 

 

 

 

2

 

 

 

(2

)

 

 

 

 

 

 

 

 

 

Reverse recapitalization transaction costs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,044

)

 

 

 

 

 

 

 

 

(9,044

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,262

 

 

 

 

 

 

 

 

 

2,262

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14,724

)

 

 

(14,724

)

Balance - March 31, 2023

 

 

 

 

$

 

 

 

 

41,106,277

 

 

$

41

 

 

$

388,963

 

 

$

 

 

$

(97,588

)

 

$

291,416

 

Exercise of common stock options

 

 

 

 

 

 

 

 

 

44,834

 

 

 

 

 

 

141

 

 

 

 

 

 

 

 

 

141

 

Vesting of restricted stock and stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

74

 

 

 

 

 

 

 

 

 

74

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,195

 

 

 

 

 

 

 

 

 

4,195

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(16,721

)

 

 

(16,721

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(111

)

 

 

 

 

 

(111

)

Balance - June 30, 2023

 

 

 

 

$

 

 

 

 

41,151,111

 

 

$

41

 

 

$

393,373

 

 

$

(111

)

 

$

(114,309

)

 

$

278,994

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

5


 

ENLIVEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)

 

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(31,445

)

 

$

(17,558

)

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

 

 

 

 

 

 

     Depreciation

 

 

141

 

 

 

91

 

     Stock-based compensation

 

 

6,457

 

 

 

1,355

 

     Amortization of premiums and discounts on marketable securities, net

 

 

(831

)

 

 

 

     Changes in operating assets and liabilities:

 

 

 

 

 

 

          Prepaid expenses, other current and long-term assets

 

 

(5,762

)

 

 

(972

)

          Operating lease right-of-use assets

 

 

(2

)

 

 

1

 

          Accounts payable

 

 

304

 

 

 

(965

)

          Accrued expenses and other liabilities

 

 

(1,755

)

 

 

563

 

Net cash used in operating activities

 

 

(32,893

)

 

 

(17,485

)

Cash flows from investing activities:

 

 

 

 

 

 

     Purchases of marketable securities

 

 

(151,430

)

 

 

 

     Purchases of property and equipment

 

 

(119

)

 

 

(497

)

Net cash used in investing activities

 

 

(151,549

)

 

 

(497

)

Cash flows from financing activities: