Candel Therapeutics (NASDAQ: CADL) posts Q1 loss, ends quarter with $194.8M cash
Rhea-AI Filing Summary
Candel Therapeutics reported a first quarter 2026 net loss of $8.9 million, reversing from net income of $7.4 million a year earlier, mainly due to higher operating expenses and a smaller gain from warrant revaluation. Research and development expenses rose to $9.8 million from $4.0 million, and general and administrative expenses increased to $6.4 million from $4.1 million, reflecting clinical, manufacturing, and commercial readiness spending for aglatimagene.
Candel strengthened its balance sheet, with cash and cash equivalents rising to $194.8 million as of March 31, 2026 from $119.7 million at year-end, helped by issuing 18.3 million shares for roughly $100 million in gross proceeds and a separate $100 million royalty funding agreement. The company expects this cash to fund operations into Q1 2028.
Strategically, Candel plans to submit a Biologics License Application for aglatimagene in localized, intermediate- to high-risk prostate cancer in Q4 2026, initiate a pivotal phase 3 trial in metastatic non-small cell lung cancer in June 2026, and has secured a U.S. commercialization partnership with EVERSANA to support a potential launch.
Positive
- Stronger balance sheet and runway: Cash and cash equivalents increased to $194.8 million as of March 31, 2026, with management expecting funding into Q1 2028, supported by a $100 million equity raise and a $100 million royalty funding agreement.
- Advancing toward commercialization: The company targets a Q4 2026 Biologics License Application for aglatimagene in localized, intermediate- to high-risk prostate cancer and has a U.S. commercialization partnership with EVERSANA in place.
Negative
- Shift from profit to loss: Results moved from net income of $7.4 million in the first quarter of 2025 to a net loss of $8.9 million in the first quarter of 2026, alongside significantly higher operating expenses.
- Shareholder dilution and future royalty burden: Issuance of 18.3 million new shares for roughly $100 million and a $100 million royalty funding agreement introduce dilution and future revenue sharing on U.S. aglatimagene sales.
Insights
Cash runway extended with clear late-stage plans for CAN-2409.
Candel Therapeutics combined a sizable equity raise and a $100 million royalty funding agreement to lift cash to $194.8 million as of March 31, 2026. Management states this should fund operations into Q1 2028, covering key regulatory and clinical steps.
The quarter shows heavy investment: R&D more than doubled to $9.8 million and G&A rose to $6.4 million, driving a net loss of $8.9 million. At the same time, extended survival data in NSCLC and multiple FDA designations for aglatimagene and linoserpaturev support continued late-stage development.
Planned milestones include a Q4 2026 BLA submission for localized prostate cancer and a pivotal NSCLC phase 3 starting in June 2026. Subsequent company filings may clarify regulatory interactions, commercialization readiness with EVERSANA, and how royalty obligations affect future net product economics.
8-K Event Classification
Key Figures
Key Terms
Biologics License Application regulatory
Fast Track Designation regulatory
Regenerative Medicine Advanced Therapy Designation regulatory
Special Protocol Assessment regulatory
Orphan Drug Designation regulatory
royalty funding agreement financial
Earnings Snapshot
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On May 14, 2026, Candel Therapeutics, Inc. announced its financial results for the quarter ended March 31, 2026. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is furnished herewith and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Description |
99.1 |
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Press Release dated May 14, 2026 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Candel Therapeutics, Inc. |
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May 14, 2026 |
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/s/ Paul Peter Tak |
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Paul Peter Tak, M.D., Ph.D., FMedSci |
Exhibit 99.1
Candel Therapeutics Reports First Quarter 2026 Financial Results and Recent Corporate Highlights
NEEDHAM, Mass., May 14, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for patients with cancer, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update.
“The quarter was marked by strong execution across our lead clinical programs, commercial readiness efforts, and further strengthening of our balance sheet,” said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. “Our primary focus remains on preparing for our planned BLA submission in Q4 2026 for aglatimagene in
ACTIVE/205254826.2
localized, intermediate- to high-risk prostate cancer. In parallel, we continue to follow patients from our phase 3 localized prostate cancer trial, with extended follow up data to be presented in a plenary oral presentation in May 2026 at AUA and additional biomarker data to be announced in Q3 2026. We are also encouraged by the persistent survival tail observed after extended follow-up from our phase 2a NSCLC trial and look forward to the planned initiation of a pivotal NSCLC phase 3 trial in June 2026.”
Dr. Tak continued, “On the commercial readiness front, we are encouraged by our progress in building a differentiated, partnership-driven model that leverages the expertise of world-class organizations EVERSANA® and IDEA Pharma. We believe this approach can enhance speed, flexibility, and scalability, positioning Candel for a successful and timely commercial launch of aglatimagene, if approved, for patients with localized prostate cancer.”
First Quarter 2026 & Recent Highlights
Anticipated Milestones
Financial Results for the First Quarter Ended March 31, 2026
Research and Development Expenses: Research and development expenses were $9.8 million for the first quarter of 2026 compared to $4.0 million for the first quarter of 2025. The increase was primarily due to higher clinical trial and manufacturing costs, in support of the Company’s aglatimagene programs, and an increase in employee-related expenses. Research and development expenses included a non-cash stock compensation expense of $0.6 million for the first quarter of 2026, as compared to a non-cash stock compensation expense of ($0.1) million for the first quarter of 2025.
General and Administrative Expenses: General and administrative expenses were $6.4 million for the first quarter of 2026, compared to $4.1 million for the first quarter of 2025. The increase was primarily due to higher commercial readiness costs and an increase in employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $0.8 million for the first quarter of 2026, as compared to a non-cash stock compensation expense of $0.4 million for the first quarter of 2025.
Net Income/Loss: Net loss for the first quarter of 2026 was $8.9 million compared to net income of $7.4 million for the first quarter of 2025 and included net other income of $7.4 million and $15.5 million, respectively. The decrease in net other income was primarily related to the change in the fair value of the Company’s warrant liabilities.
Cash Position: Cash and cash equivalents, as of March 31, 2026, were $194.8 million compared to $119.7 million as of December 31, 2025. Based on current operating plans, the Company expects that its existing cash and cash equivalents, as of March 31, 2026, will be sufficient to fund operations into Q1 2028.
About aglatimagene besadenovec (CAN-2409)
Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date,
supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the FDA or any other regulatory authority for any use.
About linoserpaturev (CAN-3110)
Linoserpaturev is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where linoserpaturev was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, Science Translational Medicine presented findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of rHGG from the U.S. Food and Drug Administration (FDA).
About Candel Therapeutics
Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. Aglatimagene besadenovec (aglatimagene or CAN-2409) is the lead product candidate from the adenovirus platform. The Company recently completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC.
Linoserpaturev (CAN-3110) is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in rHGG. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.
For more information about Candel, visit: www.candeltx.com.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including the timing and availability of additional data and key data readout milestones and presentations; expectations regarding the submission of the BLA for CAN-2409 in intermediate-to-high-risk localized prostate cancer; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat solid tumors; expectations regarding the potential benefits conferred by regulatory designations; expectations regarding the royalty funding agreement with RTW and the intended and potential benefits thereof; expectations regarding the Company’s ability to prepare and implement commercialization plans for aglatimagene in partnership with EVERSANA and IDEA and the potential benefits and duration of such partnerships; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the
Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Investor Contact
Theodore Jenkins
Vice President, Investor Relations and Business Development
Candel Therapeutics, Inc.
tjenkins@candeltx.com
Media Contact
Ben Shannon
ICR Healthcare
CandelPR@icrhealthcare.com
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1 Ling AL, et al. Nature. 2023;623(7985):157-166
Candel Therapeutics, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
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THREE MONTHS ENDED MARCH 31, |
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2026 |
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2025 |
Operating expenses: |
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Research and development |
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$ 9,840 |
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$ 4,016 |
General and administrative |
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6,444 |
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4,114 |
Total operating expenses |
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16,284 |
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8,130 |
Loss from operations |
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(16,284) |
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(8,130) |
Other income (expense): |
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Grant income |
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22 |
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— |
Interest income |
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1,322 |
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934 |
Interest expense |
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(1,564) |
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(306) |
Change in fair value of warrant liabilities |
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7,643 |
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14,881 |
Total other income, net |
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7,423 |
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15,509 |
Net income (loss) and comprehensive income (loss) |
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$ (8,861) |
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$ 7,379 |
Net income (loss) per share, basic |
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$ (0.14) |
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$ 0.15 |
Weighted-average common shares outstanding, basic |
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62,361,897 |
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50,482,278 |
Net income (loss) per share, diluted |
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$ (0.14) |
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$ 0.13 |
Weighted-average common shares outstanding, diluted |
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62,361,897 |
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54,765,842 |
Candel Therapeutics, Inc.
Consolidated Balance Sheet Data
(in thousands)
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MARCH 31, |
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DECEMBER 31, |
Cash and cash equivalents |
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$ 194,834 |
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$ 119,731 |
Working capital (1) |
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190,701 |
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112,392 |
Total assets |
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201,920 |
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125,195 |
Warrant liabilities |
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7,955 |
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15,598 |
Total other liabilities |
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55,936 |
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57,675 |
Accumulated deficit |
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(239,248) |
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(230,387) |
Total stockholders' equity |
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$ 138,029 |
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$ 51,922 |
(1) Working capital is calculated as current assets less current liabilities