Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Limitations on Effectiveness of Controls and Procedures
Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Evaluation of Disclosure Controls and Procedures
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Securities and Exchange Act of 1934, as amended). We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act) that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and (2) accumulated and communicated to our management, including our principal executive and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their control objectives.
Our management, with the participation of our Chief Executive Officer and Interim Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2024. Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, our Chief Executive Officer and Interim Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management's Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as a process designed by, or under the supervision of, a company’s principal executive officer and principal financial officer, or persons performing similar functions, and effected by a company’s board of directors, management, and other personnel, 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 and includes those policies and procedures that:
• pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of a company’s assets;
• provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that a company’s receipts and expenditures are being made only in accordance with authorizations of the company’s management and directors; and
• provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Under the supervision of and with the participation of our principal executive officer and principal financial
117
officer, our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2024 based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework (2013). Based on this assessment, management concluded that our internal control over financial reporting was effective as of December 31, 2024.
This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm on internal control over financial reporting due to an exemption established by the JOBS Act for “emerging growth companies.”
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act) that occurred during the three months ended December 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
(a) None.
(b) The following table describes contracts, instructions or written plans for the sale or purchase of our securities adopted by our directors and certain officers during the fourth quarter of 2024, each of which is intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c), referred to as Rule 10b5-1 trading plans.
Name
Action Taken
Nature of Trading Arrangement
Duration of Trading Arrangement
Aggregate Number of Securities
Paul Peter Tak , M.D., Ph.D., FMedSci ( Chief Executive Officer, President and Director )
Adoption ( November 19, 2024 )
Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)
Earlier of (i) 466 days and (ii) the completed sale of the maximum aggregate number of securities under the plan
Up to 868,783 shares
Charles Schoch ( Interim Chief Financial Officer, Treasurer and Secretary )
Adoption ( November 15, 2024 )
Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)
Earlier of (i) 379 days and (ii) the completed sale of the maximum aggregate number of securities under the plan
Up to 20,000 shares
Francesca Barone , M.D., Ph.D. ( Chief Scientific Officer )
Adoption ( November 22, 2024 )
Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)
Earlier of (i) 372 days and (ii) the completed sale of the maximum aggregate number of securities under the plan
Up to 38,646 shares
W. Garrett Nichols , M.D., M.S. ( Chief Medical Officer )
Adoption ( November 22, 2024 )
Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)
Earlier of (i) 372 days and (ii) the completed sale of the maximum aggregate number of securities under the plan
Up to 49,848 shares
Seshu Tyagarajan , Ph.D. RAC ( Chief Technical Development Director )
Adoption ( November 15, 2024 )
Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)
Earlier of (i) 470 days and (ii) the completed sale of the maximum aggregate number of securities under the plan
Up to 61,278 shares
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections .
Not applicable.
118
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The information required by this Item 10 will be included in our Definitive Proxy Statement to be filed with the Securities and Exchange Commission (SEC) with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 11. Executive Compensation.
The information required by this Item 11 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this Item 12 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item 13 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 14. Principal Accountant Fees and Services .
Our independent public accounting firm is KPMG LLP, Boston, Massachusetts, PCAOB Auditor ID 185 .
The information required by this Item 14 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference.
119
PART IV
Item 15. Exhibits and Financial Statement Schedules.
For a list of the financial statements included herein, see Index to the Consolidated Financial Statements on page F-1 of this Annual Report on Form 10-K, incorporated into this Item by reference.
Financial statement schedules have been omitted because they are either not required or not applicable or the information is included in the consolidated financial statements or the notes thereto.
Exhibits
Exhibit
Number
Description
3.1
Amended and Restated Certificate of Incorporation of Candel Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on July 30, 2021)
3.2
Amended and Restated Bylaws of Candel Therapeutics, Inc. (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on July 30, 2021)
3.3
Amendment to the Amended and Restated Bylaws of Candel Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K filed with the SEC on May 30, 2024)
4.1
Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
4.2*
Description of Securities
4.3
Investors’ Rights Agreement (incorporated by reference to Exhibit 4.2 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on June 25, 2021)
4.4
Form of November 2018 Unconditional Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.3 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
4.5
Form of November 2018 Conditional Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.4 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
4.6
Form of Warrant to Purchase Series A Convertible Preferred Stock (incorporated by reference to Exhibit 4.5 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on June 25, 2021)
4.7
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 13, 2024)
10.1#
2015 Stock Plan, as amended, and forms of award agreements thereunder (incorporated by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
10.2#
2021 Stock Option and Incentive Plan and forms of award agreements thereunder (incorporated by reference to Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
10.3#
Senior Executive Cash Incentive Bonus Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
10.4#
Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
10.5#
Employment Agreement by and between Advantagene, Inc. d/b/a Candel Therapeutics and Paul Peter Tak, M.D., Ph.D. dated September 12, 2020 (incorporated by reference to Exhibit 10.5.1 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
10.6#
Form of Indemnification Agreement (incorporated by reference to Exhibit 10.6 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
10.7
Exclusive License Agreement by and between Advantagene, Inc. and Ventagen, LLC dated March 1, 2014 (incorporated by reference to Exhibit 10.7 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
120
10.8
Exclusive License Agreement by and between Advantagene, Inc., d/b/a Candel Therapeutics and Periphagen, Inc. dated December 9, 2019 (incorporated by reference to Exhibit 10.8 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
10.9
Exclusive Patent License Agreement by and between Advantagene, Inc. and Mass General Brigham (formerly known as The Brigham and Women’s Hospital, Inc.) dated September 15, 2020 (incorporated by reference to Exhibit 10.9 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
10.10
Lease of Premises at 117 Kendrick Street, Needham, Massachusetts by and between 117 Kendrick DE, LLC and the Registrant dated as of February 4, 2019 (incorporated by reference to Exhibit 10.10 to the Registrant’s Registration Statement on Form S-1/A (File No. 333- 257444) filed with the SEC on July 16, 2021)
10.11
Loan and Security Agreement by and between the Registrant and Silicon Valley Bank, dated February 24, 2022 (incorporated by reference to Exhibit 10.11 to the Registrant's Annual Report on Form 10-K filed with the SEC on March 29, 2022)
10.12#
Employment Agreement by and between Candel Therapeutics and Francesca Barone dated February 3, 2022 (incorporated by reference to Exhibit 10.12 to the Registrant's Annual Report on Form 10-K filed with the SEC on March 29, 2022)
10.13#
Consulting Agreement by and between Candel Therapeutics, Inc. and Susan Stewart dated October 19, 2021 (incorporated by reference to Exhibit 10.13 to the Registrant's Annual Report on Form 10-K filed with the SEC on March 29, 2022)
10.14#
Employment Agreement by and between Candel Therapeutics and Seshu Tyagarajan dated April 14, 2022 (incorporated by reference to Exhibit 10.8 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on May 12, 2022)
10.15#
Employment Agreement by and between Candel Therapeutics and Jason A. Amello dated September 21, 2022 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on November 10, 2022)
10.16**
Master Production Services Agreement by and between Candel Therapeutics and SAFC Carlsbad, Inc., effective November 3, 2022 (incorporated by reference to Exhibit 10.16 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 30, 2023)
10.17**
Amendment to Exclusive License Agreement by and between Candel Therapeutics, Inc. and Periphagen, Inc. dated June 7, 2023 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on August 10, 2023)
10.18
First Amendment to Loan and Security Agreement by and between Candel Therapeutics, Inc. and Silicon Valley Bank, dated June 14, 2023 (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on August 10, 2023)
10.19#
Consulting by and between Candel Therapeutics, Inc. and Jason A. Amello, dated as of January 12, 2024 (incorporated by reference to Exhibit 10.19 to the Registrant's Annual Report on Form 10-K filed with the SEC on March 28, 2024)
19.1*
Candel Therapeutics, Inc. Insider Trading Policy
21.1
List of Subsidiary (incorporated by reference to Exhibit 21.1 to the Registrant's Annual Report on Form 10-K filed with the SEC on March 29, 2022)
23.1*
Consent of KPMG LLP, Independent Registered Public Accounting Firm
24.1*
Power of Attorney (included on signature page)
31.1*
Certification of Principal Executive Officer 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
31.2*
Certification of Principal Financial Officer 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
32.1*+
Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
97.1
Compensation Recovery Policy (incorporated by reference to Exhibit 97.1 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 28, 2024)
101.INS
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.
101.SCH
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
* Filed herewith.
121
+ The certifications furnished in Exhibit 32.1 hereto are deemed to be furnished with this Annual Report on form 10-K and will not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
# Indicates a management contract or any compensatory plan, contract or arrangement
** Portions of this exhibit have been omitted by means of redacting a portion of the text and replacing it with “[***]” because they are both (i) not material and (ii) the type of information that the Registrant treats as private or confidential.
Item 16. Form 10-K Summary .
Not applicable.
122
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm
F- 2
Consolidated Balance Sheets
F- 3
Consolidated Statements of Operations
F- 4
Consolidated Statements of Stockholders’ Equity
F- 5
Consolidated Statements of Cash Flows
F- 6
Notes to Consolidated Financial Statements
F- 7
F- 1
Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors
Candel Therapeutics, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Candel Therapeutics, Inc. and subsidiary (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years then ended, and the related notes (collectively, the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the years then ended, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ KPMG LLP
We have served as the Company’s auditor since 2019.
Boston, Massachusetts
March 13, 2025
F- 2
Candel Therapeutics, Inc.
Consolidated Ba lance Sheets
(In thousands, except share and per share amounts)
DECEMBER 31,
2024
2023
Assets
Current assets:
Cash and cash equivalents
$
102,654
$
35,413
Prepaid expenses and other current assets
1,150
1,384
Total current assets
103,804
36,797
Fixed assets, net
2,191
3,206
Lease right of use assets
542
816
Restricted cash
266
266
Other assets
63
116
Total assets
$
106,866
$
41,201
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
237
$
422
Accrued expenses
5,113
4,356
Current portion of term loan payable to a bank
9,895
8,893
Current portion of lease liability
566
513
Warrant liability
21,718
—
Total current liabilities
37,529
14,184
Term loan payable to a bank
1,733
11,632
Other long-term debt
870
751
Lease liability, net of current portion
407
973
Warrant liability
—
916
Total liabilities
40,539
28,456
Commitments and contingencies (Note 15)
Stockholders’ equity:
Preferred stock, $ 0.01 par value; 10,000,000 shares authorized at December 31, 2024 and 2023; no shares issued or outstanding at December 31, 2024 and 2023, respectively.
—
—
Common stock, $ 0.01 par value; 150,000,000 shares authorized at December 31, 2024 and 2023; 46,933,088 and 29,213,627 shares issued at December 31, 2024 and 2023, respectively; and 46,810,480 and 29,091,019 shares outstanding at December 31, 2024 and 2023, respectively.
469
290
Treasury stock (at cost)
( 448
)
( 448
)
Additional paid-in capital
258,511
149,931
Accumulated deficit
( 192,205
)
( 137,028
)
Total stockholders’ equity
66,327
12,745
Total liabilities and stockholders’ equity
$
106,866
$
41,201
The accompanying notes are an integral part of these consolidated financial statements.
F- 3
Candel Therapeutics, Inc.
Consolidated Statements of Ope rations
(In thousands, except share and per share amounts)
YEAR ENDED DECEMBER 31,
2024
2023
Operating expenses:
Research and development
$
19,314
$
24,506
General and administrative
14,057
13,885
Total operating expenses
33,371
38,391
Loss from operations
( 33,371
)
( 38,391
)
Other income (expense):
Interest income
1,086
2,081
Interest expense
( 2,090
)
( 2,595
)
Change in fair value of warrant liability
( 20,802
)
966
Total other income (expense), net
( 21,806
)
452
Net loss and comprehensive loss
$
( 55,177
)
$
( 37,939
)
Net loss per share, basic and diluted
$
( 1.74
)
$
( 1.31
)
Weighted-average common shares outstanding, basic and diluted
31,675,076
28,935,289
The accompanying notes are an integral part of these consolidated financial statements.
F- 4
Candel ThErapeutics, Inc.
Consolidated Statements of Stockholders’ Equity
(In thousands, except share and per share amounts)
COMMON STOCK
TREASURY STOCK
SHARES
AMOUNT
SHARES
AMOUNT
ADDITIONAL
PAID-IN CAPITAL
ACCUMULATED
DEFICIT
STOCKHOLDERS’
EQUITY
Balance as of December 31, 2022
29,042,418
$
290
( 122,608
)
$
( 448
)
$
146,961
$
( 99,089
)
$
47,714
Stock-based compensation
—
—
—
—
3,137
—
3,137
Restricted stock unit vesting, net
of shares withheld for taxes
171,209
—
—
—
( 121
)
—
( 121
)
Change in fair value of
NC Ohio Trust Warrants
—
—
—
—
( 46
)
—
( 46
)
Net loss
—
—
—
—
—
( 37,939
)
( 37,939
)
Balance as of December 31, 2023
29,213,627
$
290
( 122,608
)
$
( 448
)
$
149,931
$
( 137,028
)
$
12,745
Issuance of common stock and
accompanying pre-funded warrants
in public offering, net of issuance
costs of $ 6.1 million
12,000,001
120
—
—
85,808
—
85,928
Sale of common stock through
at-the-market offerings, net of
issuance costs of $ 0.5 million
2,936,057
29
—
—
15,801
—
15,830
Options exercised
846,943
9
—
—
1,680
—
1,689
Stock-based compensation
—
—
—
—
4,170
—
4,170
Restricted stock unit vesting
1,936,460
21
—
—
( 21
)
—
—
Change in fair value of
NC Ohio Trust Warrants
—
—
—
—
1,142
—
1,142
Net loss
—
—
—
—
—
( 55,177
)
( 55,177
)
Balance as of December 31, 2024
46,933,088
$
469
( 122,608
)
$
( 448
)
$
258,511
$
( 192,205
)
$
66,327
The accompanying notes are an integral part of these consolidated financial statements.
F- 5
Candel Therapeutics, Inc.
Consolidated Statements of Cas h Flows
(In thousands, except share and per share amounts)
YEAR ENDED
DECEMBER 31,
2024
2023
Cash Flows from Operating Activities:
Net loss
$
( 55,177
)
$
( 37,939
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
990
960
Impairment of fixed assets
41
390
Loss on the sale of fixed assets
—
79
Non-cash stock compensation expense
5,312
3,091
Non-cash lease expense
274
240
Non-cash interest expense
119
103
Change in fair value of warrant liability
20,802
( 966
)
Accretion of debt discount
270
323
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
234
503
Other assets
53
( 116
)
Accounts payable
( 185
)
45
Accrued expenses
757
( 301
)
Deferred income
—
( 192
)
Lease liability
( 513
)
( 464
)
Net cash used in operating activities
( 27,023
)
( 34,244
)
Cash Flows from Investing Activities:
Purchase of fixed assets
( 16
)
( 457
)
Proceeds from the sale of fixed assets
—
177
Net cash used in investing activities
( 16
)
( 280
)
Cash Flows from Financing Activities:
Proceeds from issuance of common stock and accompanying pre-funded warrants in public offering, net of issuance costs
85,928
—
Proceeds from sale of common stock through at-the-market offerings, net of issuance costs
15,830
—
Proceeds from option exercises
1,689
—
Principal payments on term loan
( 9,167
)
—
Payments related to tax withholding for vested restricted stock units
—
( 121
)
Net cash provided by (used in) financing activities
94,280
( 121
)
Net increase (decrease) in cash, cash equivalents and restricted cash
67,241
( 34,645
)
Cash, cash equivalents and restricted cash at beginning of period
35,679
70,324
Cash, cash equivalents and restricted cash at end of period
$
102,920
$
35,679
Supplemental cash flow information:
Cash paid for interest
$
1,795
$
2,148
The accompanying notes are an integral part of these consolidated financial statements.
F- 6
Candel Therapeutics, Inc.
Notes to consolidated fin ancial statements
1. Organization and Basis of Presentation
Candel Therapeutics, Inc., formerly known as Advantagene, Inc. (the Company), is a clinical stage biopharmaceutical company that was incorporated in Delaware in June 2003. On November 30, 2020, the Company changed its name to Candel Therapeutics, Inc. The Company is focused on developing off-the-shelf viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. The Company’s engineered viruses are designed to induce immunogenic cell death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens and creating a pro-inflammatory microenvironment at the site of injection. This is intended to lead to in-situ vaccination against the injected tumor and uninjected distant metastases. The Company has established two off-the-shelf viral immunotherapy platforms and its two product candidates, CAN-2409 and CAN-3110, are in clinical trials for a number of tumor types. Additionally, the Company and the University of Pennsylvania (UPenn) are collaborating to study the impact of novel viral immunotherapies based on Candel's propriety enLIGHTEN Discovery Platform, a systematic, iterative herpes simplex virus based platform leveraging human biology and advanced analytics, to strengthen the effects of UPenn's investigational CAR-T cell therapies in solid tumors.
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 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 product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.
Since inception, the Company has funded its operations primarily with proceeds from the sale of its convertible notes and capital stock and from debt borrowings. The Company has incurred recurring losses since its inception, including a net loss of $ 55.2 million and $ 37.9 million for the years ended December 31, 2024, and 2023, respectively. In addition, as of December 31, 2024, the Company had an accumulated deficit of $ 192.2 million . The Company expects to continue to generate operating losses and negative cash flows from operations for the foreseeable future.
On August 5, 2022, the Company filed a shelf registration statement on Form S-3 (as amended to date, the Shelf) with the U.S. Securities and Exchange Commission (SEC), which covers the offering, issuance, and sale by us of up to an aggregate of $ 200.0 million of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. We simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale by us of up to $ 75.0 million of our common stock from time to time in “at-the-market” offerings under the Shelf (the ATM Program). The Shelf was declared effective by the SEC on August 12, 2022. As of December 31, 2024 , the Company has sold and issued 2,936,057 shares of common stock under the ATM Program, with total net proceeds of $ 15.8 million . Subsequent to December 31, 2024 and through March 6, 2025, the Company has sold and issued 40,334 additional shares of common stock under the ATM Program, with total net proceeds of $ 0.4 million .
The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances that additional funding will be available on terms acceptable to the Company, or at all. The Company believes that existing resources will fund planned operations for at least 12 months from the issuance date of these consolidated financial statements.
Accordingly, the consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and that contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
December 2024 Public Offering
On December 16, 2024, the Company completed a public offering of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. The Company issued and sold 12,000,001 shares of common stock, including full exercise of the underwriters’ option to purchase an additional 2,000,000 shares, at a public offering price of $ 6.00 per share. Additionally, in lieu of common stock to certain investors, the Company issued and sold pre-funded warrants to purchase 3,333,333 shares of its common stock at a public offering price of $ 5.99 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $ 0.01 per share exercise price for each pre-funded warrant. The aggregate gross proceeds
F- 7
before deducting underwriting discounts and commissions, and other estimated offering expenses payable by the Company were approximately $ 92.0 million.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting standards set by the Financial Accounting Standards Board (FASB). The FASB sets generally accepted accounting principles (GAAP) that the Company follows to ensure its financial condition, results of operations, and cash flows are consistently reported. References to GAAP issued by the FASB in these notes to the financial statements are to the FASB Accounting Standards Codification (ASC).
Principles of Consolidation
The consolidated financial statements include the accounts of Candel Therapeutics, Inc. and its wholly owned subsidiary Candel Therapeutics Securities Corporation. All intercompany transactions and balances have been eliminated.
Emerging Growth Company
The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the Jobs Act). Under the Jobs Act emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the Jobs Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that is (i) no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the Jobs Act. As a result, these consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
Use of Estimates
The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and related disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. On an ongoing basis, the Company’s management evaluates its estimates, which include but are not limited to management’s judgments of accrued expenses, valuation of stock-based option awards, valuations of warrants, and income taxes. Actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with original final maturities of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents comprise marketable securities with maturities of less than three months when purchased. Cash equivalents are reported at fair value.
Restricted Cash
The Company had $ 0.3 million of restricted cash as of both December 31, 2024 and 2023 , which represents cash held as a security deposit under the terms of the Company’s Needham, Massachusetts facility lease.
Fair Value Measurements
Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
• Level 1—Quoted prices in active markets for identical assets or liabilities.
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• Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
• Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
The carrying values of cash and cash equivalents (considered as Level 1 measurements), accounts payable, and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. The carrying value of the Company's term loan approximates fair value due to the variable interest rate. The Company’s warrant liability is carried at fair value and is classified as Level 3 measurement.
Property and Equipment
Property and equipment consist of laboratory and manufacturing equipment, networking and computer equipment, furniture and fixtures and leasehold improvements. Property and equipment are recorded at cost, and depreciated using the straight-line method over the estimated useful lives of the respective assets:
ASSET
ESTIMATED USEFUL LIFE
Networking and computer equipment
5 years
Laboratory equipment
5 years
Manufacturing equipment
5 years
Furniture and fixtures
5 years
Leasehold improvements
Shorter of the useful life or remaining lease term
Leases
Lease right of use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease right of use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments to be made over the lease term. The lease right of use asset is equal to the lease liability and adjusted for prepaid rent, initial direct costs, and incentives. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected to not apply the recognition requirements of ASC 842 for short-term leases, which is defined as a lease that, at the lease commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the Company is reasonably certain to exercise.
For real estate lease agreements entered into or modified after the adoption of ASC 842 that include lease and non-lease components, the Company has elected to account for the lease and non-lease components, such as common area maintenance charges, as a single lease component term.
Concentrations of Credit Risk
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. Periodically, the Company maintains deposits in accredited financial institutions in-excess of the federally insured limits. The Company deposits its cash in financial institutions with a high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal risk associated with commercial banking relationships.
Impairment of Long-lived Assets
Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows. Long-lived assets consist of fixed assets and operating lease assets.
F- 9
During the years ended December 31, 2024 and 2023 , the Company recorded impairment charges totaling approximately $ 41,000 and $ 0.4 million, respectively, related to manufacturing equipment that the Company has determined it does not plan to use for its intended use, and the Company recorded an impairment to reduce the carrying value to its estimated fair value. The Company has not recorded any other impairment losses on such long-lived assets.
Revenue Recognition
The Company applies ASC Topic 606, Revenue from Contracts with Customers, (ASC 606). This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and then assesses whether or not each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Research and Development Costs and Accruals
Research and development expenses include salaries and benefits, materials and supplies, preclinical and clinical trial expenses, stock-based compensation expense, depreciation of equipment, contract services and other outside expenses. The Company has entered into various research and development-related contracts with clinical and research institutions, contract research organizations, and other companies. These agreements are generally cancelable, and related payments are recorded as research and development expenses as incurred. Costs of certain development activities, such as manufacturing, pre-clinical and clinical trial expenses, are recognized based on an evaluation of the progress to completion of specific tasks. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development costs. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Costs incurred in obtaining technology licenses and intellectual property are charged to research and development expenses as acquired in-process research and development if the technology licensed or intellectual property acquired has not reached technological feasibility and has no alternative future use.
Patent Costs
All patent-related costs incurred in connection with preparing, filing, maintaining and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified in general and administrative expenses.
Stock-Based Compensation
The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation (ASC 718). ASC 718 requires all share-based payments to employees and directors to be recognized as expense in the consolidated statements of operations based on their grant date fair values. In addition, in accordance with FASB Accounting Standards Update (ASU) 2016-09 which identifies areas for simplification of several areas of share-based payment transactions, the Company treats non-employee grants the same as employee grants. The Company estimates the fair value of options granted using the Black-Scholes option pricing model for stock option grants to both employees and non-employees. The Company believes the fair value of the stock options granted to non-employees is more reliably determinable than the fair value of the services provided.
The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Due to a lack of company-specific historical and implied volatility data, the Company has based its computation of expected volatility on a combination of the historical volatility of the Company and of a representative group of public companies with similar characteristics to the Company, including stage of product development and life science industry focus. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The Company uses the simplified method as prescribed by the SEC Staff Accounting Bulletin No.
F- 10
107, Share-Based Payment, to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. For options granted to non-employees, the Company utilizes the contractual term of the share-based payment as the basis for the expected term assumption. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock.
The Company generally expenses the fair value of its share-based compensation awards to employees and non-employees on a straight-line basis over the requisite service period, which is generally the vesting period.
Government Grants
The Company has applied for grants for the reimbursement of expenditures with the Massachusetts Life Sciences Center for certain qualified operating expenditures, including employee related costs. The Company recognizes government grants when there is reasonable assurance that the Company will comply with the conditions attached to the grant arrangement and the grant will be received.
Government grants are recorded as grant income and classified in other income in the consolidated statements of operations. The Company did no t recognize any government grants for the years ended December 31, 2024 and 2023 .
Income Taxes
The Company accounts for income taxes using the asset and liability method in accordance with ASC Topic 740, Income Taxes (ASC 740) which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. At December 31, 2024 and 2023, the Company has concluded that a full valuation allowance is necessary for its deferred tax assets (see Note 12).
The Company accounts for uncertainty in income taxes, by applying the two-step process to determine the amount of tax benefit to be recognized in the financial statements. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax is then assessed as the amount of benefits to be recognized in the consolidated financial statements. The amount of benefits that may be used are the largest amounts that have a greater than 50 % likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves or unrecognized tax benefits that are considered appropriate as well as the related net interest received. As of December 31, 2024 , the Company did not record any unrecognized benefits from uncertain tax positions in its consolidated financial statements.
Net Loss Per Share
Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, including the pre-funded warrants given their nominal exercise price. Diluted net loss per share is computed using the weighted-average number of shares of common stock outstanding during the period, including the pre-funded warrants given their nominal exercise price and, if dilutive, the weighted-average number of potential shares of common stock. In periods where the Company reports a net loss attributable to common stockholders, diluted net loss per share is the same as basic net loss per share, since dilutive shares of common stock are not assumed to have been issued if their effect is anti-dilutive. Diluted net loss per share is the same as basic net loss per share for the years ended December 31, 2024 and 2023 since all potential shares of common stock instruments are anti-dilutive as a result of the loss for such periods.
Recently Adopted Accounting Standards
In November 2023, the FASB issued ASU 2023-07, Segment Reporting: Improvements to Reportable Segment Disclosures, which amends guidance in ASC 280, Segment Reporting The amendments in this ASU expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment, among other disclosure requirements. The ASU’s amendments are effective for public business entities for annual
F- 11
periods beginning after December 15, 2023. The Company adopted ASU 2023-07 for the year ended December 31, 2024 (see Note 17).
Recently Issued Accounting Standards
In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative, which modifies the disclosure or presentation requirements related to a variety of FASB Accounting Standard Codification topics. The effective date for each amendment will be the date on which the SEC's removal of that related disclosure from Regulation S-X or Regulation S-K is effective, with early adoption prohibited. If by June 30, 2027, the SEC has not removed the applicable requirement from Regulation S-X or Regulation S-K, the pending content of the associated amendment will be removed from the Codification and will not become effective for any entities. The Company is currently evaluating the potential impact that ASU 2023-06 may have on its consolidated financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which amends the guidance in ASC 740, Income Taxes. The ASU is intended to improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The ASU’s amendments are effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted. Adoption can be either prospectively or retrospectively applied, and the Company will adopt this ASU on a prospective basis. The Company is currently evaluating the potential impact that ASU 2023-09 may have on its consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires additional disclosure in the notes to the financial statements of the nature of certain expenses included in the income statement. The ASU's amendments are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. Adoption can be either prospectively or retrospectively applie d. The Company is currently evaluating the potential impact that ASU 2024-03 may have on its consolidated financial statements and related disclosures.
3. Fair Value of Financial Assets and Liabilities
The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
FAIR VALUE MEASUREMENTS AS OF
DECEMBER 31, 2024 USING:
LEVEL 1
LEVEL 2
LEVEL 3
TOTAL
Liabilities:
Warrant liability
—
—
21,718
21,718
Total
$
—
$
—
$
21,718
$
21,718
FAIR VALUE MEASUREMENTS AS OF
DECEMBER 31, 2023 USING:
LEVEL 1
LEVEL 2
LEVEL 3
TOTAL
Liabilities:
Warrant liability
—
—
916
916
Total
$
—
$
—
$
916
$
916
Valuation of Warrant Liability
In connection with the November 13, 2018 issuance of Series B convertible preferred stock, the Company issued warrants to purchase shares of common stock of which certain warrants are shown as a liability on the balance sheet, see Note 10. The fair value of the warrant liability was determined based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The fair value of the warrant liability uses various valuation methods, including the Monte Carlo method, the option-pricing method, probability-weighted expected return and the hybrid method, all of which incorporate assumptions and estimates, to value the common stock warrants. The hybrid method is often used when a company is expecting a liquidity event in the near future and is a combination of the option-pricing and probability-weighted expected return methods. Estimates and assumptions impacting the fair value measurement include the fair value per share of the underlying shares of common stock, risk-free interest rate, expected dividend yield, expected volatility of the price of the underlying common stock, and the
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remaining contractual term of the warrants. The most significant assumption in the model impacting the fair value of the common stock warrants is the fair value of the Company’s common stock as of each remeasurement date.
The following table provides a roll forward of the aggregate fair values of the Company’s warrant liability, for which fair value is determined by Level 3 inputs (in thousands):
SERIES B
WARRANT
LIABILITY
Balance at December 31, 2022
$
1,882
Change in fair value
( 966
)
Balance at December 31, 2023
$
916
Change in fair value
20,802
Balance at December 31, 2024
$
21,718
4. Fixed Assets, Net
Fixed assets, net consisted of the following (in thousands):
DECEMBER 31,
2024
2023
Laboratory equipment
$
1,219
$
1,209
Manufacturing equipment
695
730
Furniture and fixtures
159
159
Networking and computer equipment
85
88
Leasehold improvements
3,109
3,109
Total fixed assets
$
5,267
$
5,295
Less: accumulated depreciation
( 3,076
)
( 2,089
)
Fixed assets, net
$
2,191
$
3,206
Depreciation expense was $ 1.0 million for each of the years ended December 31, 2024 and 2023 .
5. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
DECEMBER 31,
2024
2023
Payroll and employee related expenses
$
3,038
$
2,017
Professional fees
920
128
Third-party research and development expenses
765
1,811
Other
390
400
$
5,113
$
4,356
6. Term Loan
On February 24, 2022 , the Company entered into a four-year loan and security agreement (the Loan Agreement) with Silicon Valley Bank (SVB) pursuant to which SVB has agreed to provide term loans to the Company in an aggregate principal amount of up to $ 25.0 million. The Company borrowed $ 20.0 million upon entering into the Loan Agreement. The term loan is secured by substantially all of the Company’s properties, rights and assets, except for its intellectual property, which is subject to a negative pledge under the Loan Agreement.
The term loans bear interest at a floating rate per annum equal to the greater of (A) 5.75 % and (B) the prime rate (as published in the money rates section of The Wall Street Journal) plus 2.50 %. The Company is required to make monthly interest payments, and commencing on February 1, 2024 , 24 consecutive installments of principal plus monthly payments of accrued interest. The term loans mature on January 1, 2026 . Upon repayment in full of the term loans, the Company will be required to pay a final payment fee equal to 4.50 % of the original principal amount of any funded term loan being repaid. The Loan Agreement permits voluntary prepayment of all, but not less than all, of the SVB term loans, subject to a prepayment premium of 1 % to 3 % based upon the timing of the repayment.
During the years ended December 31, 2024 and 2023, the Company recorded interest expense relating to the Loan Agreement of $ 2.0 million and $ 2.5 million , respectively. The weighted average effective interest rate as of December 31, 2024 was 11.75 %.
F- 13
The Company incurred $ 89,000 of debt issuance costs and will incur a $ 0.9 million final payment fee, which were recorded as debt discount and are being amortized over the term of the Loan Agreement. The scheduled principal payments and net carrying amount of the term loan are as follows (in thousands):
YEAR ENDING DECEMBER 31,
2025
$
10,000
2026
833
Total principal
10,833
Final payment fee
900
Less: debt discount
( 989
)
Accretion of debt discount
884
Net carrying amount
$
11,628
Less current portion
$
( 9,895
)
Long-term portion
$
1,733
The carrying value of the Company's term loan approximates fair value.
7. Other Long-Term Debt
Periphagen Note
On December 9, 2019, the Company entered into a series of asset purchase agreements with Periphagen, Inc. (Periphagen), a biopharmaceutical company focused on the development of gene therapy vectors. Under the terms of the asset purchase agreements, the Company assumed a $ 1.0 million promissory note bearing a contractual interest rate of 2 % compounded annually, with the outstanding balance and accrued interest due upon maturity in November 2027 , with no interim installments due. The estimated market rate for the Company for an unsecured loan with a maturity in November 2027 was determined to be 15.83 % as of December 9, 2019. Although the Company does not have a public credit rating, management estimates a CCC credit rating based on the Company’s financial position and stage of development. Using the commensurate rate for a CCC rated company and based on the amount due at maturity, the present value of the future cash outflow was determined to be $ 0.4 million at the transaction date. As of December 31, 2024, the carrying value of the note is $ 0.9 million . The carrying value of the note approximates fair value. Upon maturity, the Company will pay Periphagen $ 1.4 million for the outstanding balance and accrued interest due.
8. Lease
On February 4, 2019, the Company signed a lease agreement for its corporate headquarters at 117 Kendrick Street in Needham, Massachusetts. The facility consists of a 15,197 square foot property which houses the corporate, clinical, laboratory and manufacturing operations for the Company. The lease term ends on August 31, 2026 .
For each of the years ended December 31, 2024 and 2023, the Company recorded $ 0.4 million of operating lease cost and $ 0.1 millio n of variable lease cost. The total lease expense for each of the years ended December 31, 2024 and 2023 was $ 0.5 million .
Cash paid for amounts included in the lease liability for each of the years ended December 31, 2024 and 2023 was $ 0.6 million .
YEAR ENDED DECEMBER 31,
Other Information
2024
2023
Operating cash flows used for operating leases (in thousands)
$
598
$
583
Weighted-average remaining lease term (years)
1.7
2.7
Weighted-average incremental borrowing rate
7.02
%
7.02
%
The future lease payments under non-cancelable leases at December 31, 2024, are as follows (in thousands):
2025
$
613
2026
415
Total future lease payments
1,028
Less: imputed interest
( 55
)
Total lease liability
$
973
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9. Common Stock
Common Stock
Common shares are voting and dividends may be paid when, as and if declared by the board of directors.
Common Stock Reserved
The Company has reserved the following shares of common stock for future issuance as of:
DECEMBER 31,
2024
2023
Stock options outstanding
4,486,181
5,666,621
Unvested restricted stock
330,779
2,526,432
Shares available for future grant under stock option plan
2,008,379
252,053
Warrants
7,507,708
7,507,708
Pre-funded warrants
3,333,333
—
17,666,380
15,952,814
Shelf Registration and At-the-Market Offerings
On August 5, 2022, the Company filed the Shelf with the SEC, which covers the offering, issuance, and sale by us of up to an aggregate of $ 200.0 million of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. We simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale by us of up to $ 75.0 million of our common stock from time to time in “at-the-market” offerings under the Shelf. The Shelf was declared effective by the SEC on August 12, 2022. As of December 31, 2024 , the Company has sold and issued 2,936,057 shares of common stock under the ATM program, with total net proceeds of $ 15.8 million . Subsequent to December 31, 2024 and through March 6, 2025, the Company has sold and issued 40,334 additional shares of common stock under the ATM Program, with total net proceeds of $ 0.4 million .
10. Warrants
The Company has the following warrants outstanding for the purchase of common stock as of December 31, 2024 and 2023 (except the Pre-Funded Warrants which were only outstanding as of December 31, 2024):
WARRANTS
SHARES OF
COMMON
STOCK SUBJECT
TO WARRANTS
EXERCISE
PRICE PER
SHARE
EXPIRATION DATES
Series B Warrants
3,672,484
$
6.81
November 2025
Conditional Series B Warrants
3,672,484
$
6.81
November 2025
NC Ohio Trust
162,740
$
1.46
March 2029
Pre-Funded Warrants
3,333,333
$
0.01
No expiration
Series B Warrants
In connection with the November 13, 2018 issuance of Series B convertible preferred stock (the Series B Preferred), the Company issued to the purchaser of the Series B Preferred warrants to purchase 3,672,484 shares of common stock for $ 6.81 per share (the Series B Warrants), which became fully exercisable upon issuance. The Series B Warrants contain provisions allowing cashless exercise.
In addition, the Company issued to the same stockholder additional five-year warrants for the purchase of 3,672,484 shares of common stock for $ 6.81 per share (the Conditional Series B Warrants), which become exercisable in the event that the Company completes a future financing that meets certain financial milestones or achieves certain share prices as follows:
• 918,121 shares vest upon (1) a financing event effected through the sale of our equity securities to third parties resulting in at least $ 20,000,000 in gross proceeds with a per share price of $ 12.47 , or (2) an average market price (determined over a consecutive 10 -day period) of $ 12.47 per share;
F- 15
• an additional 918,121 shares vest upon (1) a financing event with a price per share of $ 13.20 , or (2) an average market price (determined over a consecutive 10 -day period) of, $ 13.20 per share;
• an additional 918,121 shares vest upon (1) a financing event with a per share price of $ 13.94 , or (2) an average market price (determined over a consecutive 10 -day period) of, $ 13.94 per share; and
• an additional 918,121 shares vest upon (1) a financing event with a per share price of $ 14.68 , or (2) an average market price (determined over a consecutive 10 -day period) of, $ 14.68 per share.
On June 24, 2021, the Company’s board of directors approved and on July 14, 2021 the stockholders approved, effective upon the closing of the Company's initial public offering (IPO), an amendment to the terms of the Series B Warrants and the Conditional Series B Warrants to extend the expiration date from November 2023 to November 2025 . In addition, the exercise period for the Conditional Series B Warrants was amended such that in the event the future financing milestones or certain share price targets described above are achieved, the Conditional Series B Warrants can only be exercised in conjunction with the sale of the Company, on a cash or cashless exercise basis, or otherwise in November 2025 through a cashless exercise.
The Company recorded the Series B Warrants as a component of stockholder’s equity at the time of issuance at their estimated fair value of $ 2.1 million and recorded the Conditional Series B Warrants as a liability on the consolidated balance sheet as the number of shares used to calculate the settlement is not a fixed number of shares. The Conditional Series B Warrants are remeasured to their fair value at each reporting date with changes in the fair value recognized as a component of other income (expense), net in the consolidated statements of operations. The Company will continue to recognize changes in the fair value of the Conditional Series B Warrants until each Conditional Series B Warrant is exercised, expires or qualifies for equity classification. The warrant liability fair value was $ 21.7 million and $ 0.9 million as of December 31, 2024 and 2023, respectively.
NC Ohio Trust Warrants
On March 20, 2019, the Company established the NC Incorporated Ohio Trust, an irrevocable trust funded by the Company. The beneficiary in the trust agreement has provided past services to the Company for more than 15 years and is a non-employee. The warrant provides the beneficiary the right to purchase 162,740 shares of the Company’s common stock, $ 0.01 par value at an exercise price of $ 1.46 per share, subject to adjustments as specified in the warrant agreement. The Company recognizes the warrants as compensation expense within the consolidated statement of operations when the warrants are granted or at the service inception date if the service inception date precedes the grant date. In the period in which the grant date occurs, cumulative compensation cost shall be adjusted to reflect the cumulative effect of measuring compensation cost based on the fair value at the grant date rather than the fair value previously used at the service inception date or subsequent reporting dates. As of December 31, 2024 and 2023 , a grant date was not established as there was not a mutual understanding of key terms. The Company remeasures the fair value of the award at each reporting date, as the service date preceded the grant date. The value of the warrants for 162,740 shares of common stock was $ 1.3 million and $ 0.2 million as of December 31, 2024 and 2023, respectively, and was recorded as stock compensation expense within research and development expense and a credit to stockholders’ equity in the consolidated financial statements.
Pre-Funded Warrants
In connection with the public offering on December 16, 2024 (see Note 1), the Company has issued pre-funded warrants to purchase common stock in lieu of common stock. As the pre-funded warrants are indexed to the Company’s common stock (and otherwise meet the requirements to be classified in equity), the Company recorded the consideration received from the issuance of the pre-funded warrants as additional paid-in capital on the Company’s consolidated balance sheet. The pre-funded warrants are exercisable at any time. The holders of Pre-Funded Warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 4.99 % of the number of shares of the Common Stock outstanding immediately after giving effect to such exercise. The holders of Pre-Funded Warrants may increase or decrease such percentages not in excess of 19.99 % by providing at least 61 days’ prior notice to the Company.
During the year ended December 31, 2024 , no pre-funded warrants were exercised. As of December 31, 2024 , there were 3,333,333 pre-funded warrants outstanding.
11. Stock Options, Restricted Stock and Stock-Based Compensation
Equity Incentive Plans
The Company’s 2015 Stock Plan, as amended, (the 2015 Plan) provides for the Company to sell or issue common shares or restricted common stock, or to grant incentive stock options or nonqualified stock options for the purchase of common stock, to employees, members of the board of directors and consultants of the Company. The 2015 Plan is
F- 16
administered by the board of directors and exercise prices, vesting and other restrictions are determined at its discretion. All stock option grants are non-statutory stock options except option grants to employees intended to qualify as incentive stock options under the Internal Revenue Code of 1986, as amended. Incentive stock options may not be granted at less than the fair market value of the Company’s common stock on the date of grant, as determined in good faith by the board of directors at its sole discretion. Nonqualified stock options may be granted at an exercise price established by the board of directors at its sole discretion and the vesting periods may vary. Vesting periods are generally four years and are determined by the board of directors. Stock options become exercisable as they vest. Options granted under the 2015 Plan expire no more than ten years from the date of grant. As of December 31, 2024 , there are no shares available for grants under the 2015 Plan and the 2015 Plan continues to govern the terms and conditions of the outstanding awards under the 2015 Plan.
On July 14, 2021, the Company’s 2021 Equity Incentive Plan (the 2021 Plan) was approved by the Company’s stockholders, and became effective upon completion of the IPO and serves as the successor to the 2015 Plan. 6,669,993 shares of common stock are reserved under the 2021 Plan, of which 2,008,379 shares remain available for future grants as of December 31, 2024.
Stock Options
Stock option activity is summarized as follows:
NUMBER OF
STOCK
OPTIONS
WEIGHTED-
AVERAGE
EXERCISE
PRICE
WEIGHTED-
AVERAGE
REMAINING
CONTRACTUAL
TERM (IN YEARS)
AGGREGATE
INTRINSIC
VALUE
(IN THOUSANDS)
Outstanding as of December 31, 2023
5,666,621
$
2.47
6.61
$
199
Granted
202,420
4.36
Exercised
( 846,943
)
1.99
Cancelled, forfeited or expired
( 535,917
)
3.36
Outstanding as of December 31, 2024
4,486,181
$
2.54
6.61
$
27,599
Exercisable as of December 31, 2024
3,515,651
$
2.40
6.20
$
22,116
Unvested as of December 31, 2024
970,530
$
3.04
8.10
$
5,483
The 2015 Plan permits participants to use common stock they previously acquired to pay for the exercise of stock options based upon the fair value on the date of exercise. In connection with the exercise of a stock options to purchase 306,518 shares of our common stock at an exercise price of $ 1.46 , option holders tendered 122,608 shares of our common stock previously acquired in consideration of the full aggregate exercise price in accordance with the terms of the option and the 2015 Plan. The shares tendered are recorded as treasury stock within the Company's consolidated financial statements at December 31, 2024.
The fair value of stock options granted was estimated on the grant date using the Black-Scholes option pricing model based on the following range of assumptions:
YEAR ENDED DECEMBER 31,
2024
2023
Expected option life (years)
5.50 - 6.08
5.48 - 6.08
Risk-free interest rate
3.98 % - 4.32 %
3.50 % - 4.86 %
Expected volatility
99.30 % - 114.68 %
91.33 % - 94.51 %
Expected dividend yield
0
%
0
%
The aggregate intrinsic value of options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the common stock as of the end of the period. The total intrinsic value of stock options exercised during the years ended December 31, 2024 and 2023 was $ 5.7 million and zero , respectively .
Restricted Stock Units
Under the terms of the restricted stock unit agreements covering the common stock, shares of common stock related to restricted stock units are subject to time-based vesting. The restricted stock units will immediately be forfeited to the Company if the relationship between the recipient and the Company ceases.
F- 17
Restricted stock activity is summarized as follows:
NUMBER OF
SHARES
OPTIONS
WEIGHTED-
AVERAGE GRANT
DATE FAIR VALUE
Unvested at December 31, 2023
2,526,432
$
1.06
Granted
—
$
—
Vested
( 1,936,460
)
$
1.07
Forfeited
( 259,193
)
$
1.11
Unvested at December 31, 2024
330,779
$
0.98
The aggregate fair value of restricted stock units that vested during the years ended December 31, 2024 and 2023 was $ 16.8 million and $ 0.5 million , respectively.
Stock-Based Compensation
Stock-based compensation expense for the years ended December 31, 2024 and 2023 was classified in the consolidated statements of operations as follows (in thousands):
YEAR ENDED DECEMBER 31,
2024
2023
Research and development
$
3,276
$
1,347
General and administrative
2,036
1,744
Total stock-based compensation expense
$
5,312
$
3,091
As of December 31, 2024 and 2023, total unrecognized compensation cost related to the unvested stock-based awards was $ 1.9 million and $ 6.1 million , respectively. As of December 31, 2024 and 2023, these amounts are expected to be recognized over a weighted average period of 2.29 and 2.40 years , respectively.
12. Income Taxes
Due to the Company's net losses for 2024 and 2023 , as well as the full valuation allowance on its net deferred tax assets as discussed below, the Company did no t record any income tax expense or benefit for the years ended December 31, 2024 and 2023 .
A reconciliation of the Company's statutory income tax rate to the Company’s effective income tax rate is as follows:
YEAR ENDED
DECEMBER 31,
2024
2023
Income at US statutory rate
21.0
%
21.0
%
Permanent adjustments
( 0.1
)%
( 1.3
)%
Mark to market
( 7.9
)%
0.5
%
Equity compensation
3.3
%
—
State taxes, net of federal benefit
3.8
%
6.9
%
Valuation allowance
( 21.1
)%
( 30.0
)%
Tax credits
1.0
%
2.9
%
—
—
Net deferred tax assets as of December 31, 2024 and 2023 consist of the following (in thousands):
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YEAR ENDED
DECEMBER 31,
2024
2023
Deferred tax assets:
Net operating losses
$
29,876
$
23,136
Intangibles
422
506
Accrued expenses and other
591
434
Lease liability
257
406
Stock compensation
987
1,168
Capitalized R&D expenditures
13,456
9,200
Credits
6,873
6,199
Total deferred tax assets
52,462
41,049
Valuation allowance
( 52,185
)
( 40,548
)
Net deferred tax assets
277
501
Deferred tax liabilities:
Right of use asset
( 143
)
( 223
)
Other
( 134
)
( 278
)
Total deferred tax liabilities
( 277
)
( 501
)
Net deferred tax assets (liabilities)
$
—
$
—
As of December 31, 2024 , the Company has gross federal and state net operating loss carryforwards of approximately $ 111.6 million and $ 101.9 million, respectively. The federal net operating loss carryforwards include $ 8.8 million that begins to expire in 2028 and $ 102.8 million that can be carried forward indefinitely. The state net operating loss carryforwards begin to expire in 2033 .
As of December 31, 2024 , the Company has gross federal and state tax credit carryforwards of approximately $ 5.0 million and $ 2.4 million, respectively, which begin to expire in 2037 and 2031 , respectively.
Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are comprised principally of net operating loss carryforwards and certain tax credits. Management has considered the Company’s history of cumulative net losses incurred since inception, as well as its lack of product revenue since inception, and has determined that it is more likely than not that the Company will not realize the benefits of its deferred tax assets. As a result, a full valuation allowance has been established at December 31, 2024 and 2023.
Section 382 of the Internal Revenue Code of 1986, as amended (Section 382), contains rules that limit the ability of a company that undergoes in ownership change to utilize its net operating losses (NOLs) and tax credits existing as of the date of such ownership change. Under the rules, such an ownership change is generally any change in ownership of more than 50% of a company’s stock within a rolling three-year period. The rules generally operate by focusing on changes in ownership of all stock considered by the rules as owning, directly or indirectly, 5% or more of the stock of a company and any change in ownership arising from new issuances of stock by the company. The Company has not yet determined if such a limitation would be placed against its available net operating losses. The Company will make such a determination prior to the utilization of any future net operating losses.
A summary of changes in the valuation allowance for deferred tax assets during the years ended December 31, 2024 and 2023 were as follows (in thousands):
YEAR ENDED
DECEMBER 31,
2024
2023
Valuation allowance
$
40,548
$
29,166
Increases recorded to income tax provision
11,637
11,382
Decreases recorded to income tax provision
—
—
Valuation allowance
$
52,185
$
40,548
The Company files income tax returns in the United States and various state and local jurisdictions. The federal and state tax returns are generally subject to examination for the years ended December 31, 2014 through December 31, 2024 . There are currently no pending tax examinations . To the extent the Company has tax attribute carryforwards, the tax year in which the attribute was generated may still be adjusted upon examination.
F- 19
13. Exclusive Licensing Agreement with a Related Party
In March 2014, the Company entered into an exclusive licensing agreement with Ventagen, LLC (Ventagen) which provides Ventagen the right to develop products for commercial sale and distribution within Mexico, Belize, Guatemala, Honduras, El Salvador, Costa Rica, Nicaragua, Panama, Colombia, and Bolivia (the Territory). Ventagen paid the Company $ 1.0 million upon the signing of the agreement and agreed to a fixed future payment to the Company of $ 2.5 million. The future payment will be made upon the achievement of $ 5.0 million of sales of an approved product by Ventagen and is subject to reduction if Ventagen’s costs to develop an approved product exceeds $ 4.0 million. In addition to the upfront payment and the future payment, Ventagen agreed to purchase from the Company all manufactured product that is required for clinical or commercial purposes at a price of cost plus 25 % of the wholesale price of the approved product, subject to a minimum or maximum price. In the event the Company is unable or unwilling to manufacture supply under the terms of the agreement, Ventagen has the right to manufacture its own supply and will be required to pay a fixed fee per dose sold. The Company also agreed to provide certain services to Ventagen related to Ventagen’s development plan. Stockholders of the Company own 49.5 % of the voting stock of Ventagen, including 47 % by the Company’s founders who are currently significant stockholders of the Company, and trusts for the benefit of their children.
The Company recognized the $ 1.0 million upfront license fee as research and development service revenue as of December 31, 2022.
14. Technology License Agreement
On January 20, 2018 the Company entered into an exclusive option agreement (Option Agreement) with MGB. Pursuant to the Option Agreement, the Company has obtained the exclusive right from MGB to negotiate an exclusive license to make, develop and commercialize rQNestin, a genetically modified oncolytic herpes simplex virus for the treatment of certain types of cancers. Pursuant to the Option Agreement, the Company will support a clinical trial to be conducted at MGB pursuant to the terms of a clinical trial agreement to be negotiated and the Company has committed to remitting $ 0.8 million in support of such clinical trial over the course of approximately three years . Upon execution of the Option Agreement, the Company remitted a non-refundable fee of $ 40,000 to MGB to be applied toward the Company’s on-going obligations to reimburse patent expenses. During the years ended December 31, 2024 and 2023 , the Company did no t expense any startup and patient fees for clinical trials performed by MGB.
On September 15, 2020, the Company exercised the Option Agreement with MGB and entered into an exclusive worldwide patent license agreement with MGB (the MGB License). In connection with the MGB License, the Company paid a fee of $ 0.1 million and agreed to reimburse patent costs incurred by MGB, including $ 0.1 million paid at the time of entering into the MGB License. Prior to the first commercial sale, the Company is required to pay MGB an annual license fee of $ 50,000 beginning following the fourth anniversary of the effective date. The MGB License contains cumulative milestone payments equaling a maximum amount of $ 39.0 million upon the achievement of various clinical, commercial and sales milestones of both primary and secondary products. Following the first commercial sale, the Company is required to pay royalties to MGB, which are paid at an increasing rate as net sales increase, ranging from low single digits to high single digits. In addition, after the first commercial sale, the Company is required to pay MGB a pre-determined fixed annual minimum royalty, which amount may be credited against earned royalties starting in the fourth year following the first commercial sale. The Company also agreed to pay a single digit royalty rate on net sales of any derived products.
15. Commitments and Contingencies
Guarantees
The Company has identified the guarantees described below as disclosable, in accordance with ASC 460, Guarantees.
As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ insurance coverage that should limit its exposure and enable it to recover a portion of any future amounts paid.
The Company is a party to a number of agreements entered into in the ordinary course of business that contain typical provisions that obligate the Company to indemnify the other parties to such agreements upon the occurrence of certain events. Such indemnification obligations are usually in effect from the date of execution of the applicable agreement for a period equal to the applicable statute of limitations. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain.
The Company leases office space under a noncancelable operating lease expiring in 2026 . The Company has standard indemnification arrangements under this lease that require it to indemnify the landlord against all costs, expenses, fines,
F- 20
suits, claims, demands, liabilities, and actions directly resulting from any breach, violation, or nonperformance of any covenant or condition of the lease.
As of December 31, 2024 , the Company had no t experienced any losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves have been established.
Legal Proceedings
From time to time, we may become involved in litigation or other legal proceedings. W e are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are probable to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.
16. Net Loss Per Share
Net Loss Per Share
Basic and diluted net loss per share attributable to common stockholders was computed by dividing net loss by the weighted-average common shares outstanding for the period, including the pre-funded warrants given their nominal exercise price (in thousands, except share and per share data):
YEAR ENDED DECEMBER 31,
2024
2023
Numerator:
Net loss
$
( 55,177
)
$
( 37,939
)
Denominator:
Weighted-average shares of common stock outstanding, basic and diluted
31,675,076
28,935,289
Net loss per share, basic and diluted
$
( 1.74
)
$
( 1.31
)
The Company’s potentially dilutive securities have been excluded from the computation of dilutive net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share is the same.
The Company excluded the following potential shares of common stock from the computation of diluted net loss per share because including them would have had an anti-dilutive effect.
YEAR ENDED DECEMBER 31,
2024
2023
Outstanding warrants for common stock
7,507,708
7,507,708
Outstanding stock options (as converted to common stock)
4,486,181
5,666,621
Unvested restricted stock
330,779
2,526,432
12,324,668
15,700,761
17. Segment Reporting
The Company operates in one business segment, which includes all activities related to the discovery, development, and potential commercialization of off-the-shelf viral immunotherapies that help patients fight cancer. The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (CODM). The Company’s CODM is its Chief Executive Officer , who reviews and evaluates consolidated net loss for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods.
In addition to the significant expense categories included within consolidated net loss presented on the Company's consolidated statements of operations, see below for disaggregated amounts that comprise research and development and general and administrative expenses:
F- 21
YEAR ENDED DECEMBER 31,
2024
2023
Operating expenses:
Research and development:
Employee-related
$
11,669
$
13,362
Clinical development
5,196
7,940
Facility and equipment costs
1,566
1,945
Pre-clinical research
384
660
Other research and development segment expenses
499
599
Total research and development
19,314
24,506
General and administrative:
Employee-related
6,831
7,573
Professional and consulting fees
5,263
3,666
Other general and administrative segment expenses (1)
1,963
2,646
Total general and administrative
14,057
13,885
Total operating expenses
33,371
38,391
Loss from operations
( 33,371
)
( 38,391
)
Interest income
1,086
2,081
Interest expense
( 2,090
)
( 2,595
)
Change in fair value of warrant liability
( 20,802
)
966
Net loss
$
( 55,177
)
$
( 37,939
)
(1) Other general and administrative segment expenses primarily consists of insurance, occupancy, and information technology costs.
18. Corporate Restructuring
In November 2023, the Company’s board of directors authorized a restructuring plan to focus on key clinical data readouts for CAN-2409 and continuation and expansion of development of CAN-3110 as well as the enLIGHTEN TM Discovery Platform, which resulted in a reduction of the Company’s workforce by approximately 45 % . Each affected employee’ s separation occurred in December 2023. As a result, the Company incurred costs of $ 0.7 million related to severance benefits for the affected employees, including severance payments and limited reimbursement of medical insurance premiums. The restructuring plan was completed in the first quarter of 2024 when the final severance payments of $ 46,000 were made.
Of the $ 0.7 million in costs recognized related to the restructuring plan, $ 0.5 million and $ 0.2 million were included in research and development and general and administrative expenses, respectively, in the accompanying consolidated statement of operations for the year ended December 31, 2023. During the year ended December 31, 2023, the Company paid $ 0.7 million in severance benefits to separating employees related to the restructuring plan.
F- 22
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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 .
Candel Therapeutics, Inc.
Date: March 13, 2025
By:
/s/ Paul Peter Tak
Paul Peter Tak, M.D., Ph.D., FMedSci
President and Chief Executive Officer
POWER OF ATTORNEY
Each person whose individual signature appears below hereby constitutes and appoints Paul Peter Tak and Charles Schoch, and each of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his substitute or substitutes may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.
Name
Title
Date
/s/ Paul Peter Tak
President and Chief Executive Officer
(Principal Executive Officer)
March 13, 2025
Paul Peter Tak, M.D., Ph.D. FMedSci
/s/ Charles Schoch
Interim Chief Financial Officer (Principal Financial and Accounting Officer)
March 13, 2025
Charles Schoch
/s/ Paul B. Manning
Chairman
March 13, 2025
Paul B. Manning
/s/ Edward J. Benz Jr.
Director
March 13, 2025
Edward J. Benz, Jr, M.D.
/s/ Chris Martell
Director
March 13, 2025
Chris Martell
/s/ Renee Gaeta
Director
March 13, 2025
Renee Gaeta
/s/ Gary Nabel
Director
March 13, 2025
Gary Nabel, Ph.D., M.D.
/s/ Joseph Papa
Director
March 13, 2025
Joseph Papa
/s/ Diem Nguyen
Director
March 13, 2025
Diem Nguyen, Ph.D., MBA
/s/ Nicoletta Loggia
Director
March 13, 2025
Nicoletta Loggia, Ph.D., R.Ph
F- 23
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.