Candel Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Highlights
Candel Therapeutics, Inc. reported financial results for Q4 2023, with positive clinical trial outcomes for CAN-2409 in pancreatic cancer and CAN-3110 in high-grade glioma. The company received FDA Fast Track Designations for both treatments, showing improved survival rates compared to standard care. Candel anticipates significant data readouts in 2024 across various cancer platforms, including a potentially registrational phase 3 trial for prostate cancer. Financially, research and development expenses increased due to activities supporting CAN-2409 programs, resulting in a net loss for Q4 2023.
Positive
Positive outcomes reported for CAN-2409 in pancreatic cancer and CAN-3110 in high-grade glioma
FDA Fast Track Designations received for CAN-2409 and CAN-3110
Anticipated data readouts in 2024 across multiple cancer platforms
Financially, research and development expenses increased due to activities supporting CAN-2409 programs
Negative
Net loss reported for Q4 2023 due to increased research and development expenses
The financial results for Candel Therapeutics, Inc. indicate a substantial increase in research and development expenses from $20.8 million in the full year 2022 to $24.5 million in 2023, which reflects the company's commitment to advancing its product pipeline. However, this has also led to a significant widening of the net loss, from $18.8 million in 2022 to $37.9 million in 2023. The shift from net other income to net other expense is a key factor in this increased loss, primarily due to changes in the fair value of the company's warrant liability.
The company's cash position has decreased by nearly 50%, from $70.1 million to $35.4 million year-over-year, which may raise concerns about the company's ability to sustain its operations without additional financing, especially since the cash runway is expected to last only until the fourth quarter of 2024. Investors should be aware of the potential need for additional capital raises, which could lead to dilution of existing shares.
The FDA Fast Track Designations for Candel's CAN-2409 and CAN-3110 are significant as they could expedite the review process and enhance the speed at which these treatments may come to market if proven effective. The publication of CAN-3110's phase 1b clinical trial results in Nature, a prestigious journal, adds credibility to the research and could positively influence investor perception.
However, the true impact on both the business and patients will hinge on the upcoming data readouts. The phase 3 clinical trial in prostate cancer, expected in Q4 2024, is particularly noteworthy as it may serve as a basis for registration, potentially bringing the treatment to market. The implications for stakeholders are considerable; successful trials could lead to a new treatment option for cancer patients and provide a significant commercial opportunity for Candel. On the flip side, any setbacks in these trials could have a pronounced negative effect on the company's valuation and financial health.
From a market perspective, the anticipation of multiple data readouts across Candel's platforms in 2024 positions the company at a pivotal point. The market for cancer immunotherapies is highly competitive and positive results could position Candel as a strong player in this space, potentially attracting partnership opportunities and boosting investor confidence.
Investors should note the correlation between clinical milestones and stock volatility; as each data readout approaches, the company's stock price may experience significant fluctuations. The long-term impact will depend on the outcomes of these trials, with positive data likely to result in increased market share and revenue growth, while negative results could hinder Candel's competitive position and financial stability.
03/28/2024 - 08:05 AM
On track for topline data from CAN-2409 phase 3 in localized intermediate/high risk prostate cancer, expected in Q4 2024 Results from ongoing, first-in-human, phase 1b clinical trial of CAN-3110, in recurrent high-grade glioma, published in Nature Catalyst-rich 2024 paves way for transformational year NEEDHAM, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today reported financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update.
“2023 was a significant year for Candel with two additional FDA Fast Track Designations for CAN-2409 for non-small cell lung cancer and borderline resectable pancreatic cancer, and most recently Candel received FDA Fast Track Designation for CAN-3110 for recurrent high-grade glioma in February of 2024. We are also excited that initial results in CAN-3110’s ongoing phase 1b clinical trial were published in the high-impact scientific journal, Nature,” said Paul Peter Tak, MD PhD FMedSci, President and CEO of Candel. “Further, initial patient data showed improved survival after experimental treatment with Candel’s investigational viral multimodal immunotherapies, as compared to standard of care, in non-small cell lung cancer (CAN-2409), pancreatic cancer (CAN-2409), and high-grade glioma (CAN-3110).”
Dr. Tak continued, “In 2024, we are expecting six data readouts across our three platforms, which include novel clinical and biomarker data in lung cancer, pancreatic cancer, and brain cancer, and a potentially registrational phase 3 clinical trial in prostate cancer. We look forward to sharing additional updates in the year ahead.”
Fourth Quarter 2023 & Recent Highlights
CAN-2409 – Pancreatic Cancer Announced initial positive interim data from our randomized phase 2 clinical trial of CAN-2409 in non-metastatic pancreatic cancer which showed prolonged and sustained survival, robust activation of immune response after dosing of CAN-2409, and a favorable tolerability profile. U.S. Food and Drug Administration (FDA) granted Fast Track Designation for CAN-2409 plus prodrug (valacyclovir) for the treatment of patients with pancreatic ductal adenocarcinoma to improve overall survival (OS). CAN-3110 - Recurrent High-Grade Glioma (HGG) The results from the ongoing first-in-human phase 1b clinical trial of CAN-3110 in recurrent high-grade glioma, showing extended survival associated with immune activation, were published online on October 18, 2023, in Nature FDA granted Fast Track Designation to CAN-3110 for the treatment of patients with recurrent high-grade glioma (HGG) to improve OS. enLIGHTEN ™ Discovery Platform CAN-2409 – Pancreatic Cancer Presented encouraging preclinical data from the first experimental candidate from its discovery pipeline, Alpha 201-macro-1, at both the Society for Immunotherapy of Cancer (SITC) and the International Oncolytic Virus Conference (IOVC) in November 2023. This investigational, locally delivered, biological oncolytic therapeutic, which is designed to interfere with the CD47/SIRP1a pathway, demonstrated better inhibition of tumor growth, when compared to systemic anti-CD47 antibody therapy, in a mouse model of breast cancer. Announced an upcoming "late-breaking” poster presentation at the 2024 AACR Annual Meeting unveiling the second drug candidate from the enLIGHTEN™ Discovery Platform. Anticipated Milestones
New preclinical data on the second drug candidate from the enLIGHTEN™ Discovery Platform to be presented at the 2024 AACR Annual Meeting taking place April 5-10, 2024 Phase 2 topline OS data for CAN-2409 in NSCLC expected in Q2 2024 Phase 2 updated OS data for CAN-2409 in borderline resectable pancreatic cancer expected in Q2 2024 Phase 2 topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer expected in Q4 2024 Phase 3 topline data for CAN-2409 in localized intermediate/high-risk prostate cancer expected in Q4 2024 Financial Results for the Year and Fourth Quarter Ended December 31, 2023
Resea r ch and Development Service Revenue, related party: Research and development service revenue, related party, for each of the quarter and full year ended December 31, 2023 was $0 , as compared to $31,000 and $125,000 for the quarter and full year ended December 31, 2022.
Resea r ch and Development Expenses: Research and development expenses were $7.3 million for the fourth quarter of 2023 compared to $5.0 million for the fourth quarter of 2022, and $24.5 million for the full year 2023 compared to $20.8 million for the full year 2022. The increase was primarily due to manufacturing and regulatory activities in support of the Company’s CAN-2409 programs, stock compensation costs, and impairment of fixed assets. Research and development expenses included non-cash stock compensation expense of $0.5 million and $1.3 million for the fourth quarter and full year of 2023, respectively, as compared to a non-cash stock compensation expense of $0.2 million and $0.8 million for the fourth quarter and full year of 2022.
General and Administrative Expenses: General and administrative expenses were $3.1 million for the fourth quarter of 2023 compared to $3.2 million for the fourth quarter of 2022, and $13.9 million for the full year 2023 compared to $14.1 million for the full year 2022. The decrease was primarily due to lower insurance and recruiting costs, which were partially offset by increased employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $0.5 million and $1.7 million for the fourth quarter and full year of 2023, respectively, as compared to a non-cash stock compensation expense of $0.4 million and $1.5 million for the fourth quarter and full year of 2022.
Net Loss: Net loss for the fourth quarter of 2023 was $11.1 million compared to a net loss of $5.1 million for the fourth quarter of 2022, and included net other expense of $0.8 million and net other income $3.0 million , respectively. The change from net other income in the fourth quarter of 2022 to net other expense in the fourth quarter of 2023 was primarily related to the change in the fair value of the Company’s warrant liability. Net loss for the full year 2023 was $37.9 million compared to a net loss of $18.8 million for the full year 2022, and included net other income of $0.5 million and $15.9 million , respectively, related primarily to the change in the fair value of the Company’s warrant liability.
Cash Position: Cash and cash equivalents as of December 31, 2023 were $35.4 million , as compared to $70.1 million as of December 31, 2022. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the fourth quarter of 2024.
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. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). 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 development programs, including the timing and availability of additional data, key data readout milestones, expectations regarding the therapeutic benefit of the Company’s programs, including the potential for its programs to extend patient survival; 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; the Company’s ability to continue as a going concern; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s pre-clinical 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, 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 filed with the SEC, and 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 tjenkins@candeltx.com
Media Contact areynolds@wheelhouselsa.com
Candel Therapeutics, Inc. THREE MONTHS ENDED DECEMBER 31, TWELVE MONTHS ENDED DECEMBER 31, 2023 2022 2023 2022 Research and development service revenue, related party $ — $ 31 $ — $ 125 Operating expenses: Research and development 7,258 4,972 24,506 20,787 General and administrative 3,060 3,160 13,885 14,060 Total operating expenses 10,318 8,132 38,391 34,847 Loss from operations (10,318 ) (8,101 ) (38,391 ) (34,722 ) Other income (expense): Grant income (36 ) 48 — 48 Interest income 415 804 2,081 1,218 Interest expense (673 ) (578 ) (2,595 ) (1,708 ) Change in fair value of warrant liability (483 ) 2,744 966 16,370 Total other income (expense), net (777 ) 3,018 452 15,928 Net loss and comprehensive loss $ (11,095 ) $ (5,083 ) $ (37,939 ) $ (18,794 ) Net loss per share, basic and diluted $ (0.38 ) $ (0.18 ) $ (1.31 ) $ (0.65 ) Weighted-average common shares outstanding, basic and diluted 28,981,222 28,899,426 28,935,289 28,823,480
Candel Therapeutics, Inc. DECEMBER 31, 2023 DECEMBER 31, 2022 Cash and cash equivalents $ 35,413 $ 70,058 Working capital (1) 22,613 66,330 Total assets 41,201 77,691 Warrant liability 916 1,882 Total other liabilities 27,540 28,095 Accumulated deficit (137,028 ) (99,089 ) Total stockholders equity $ 12,745 $ 47,714 (1) Working capital is calculated as current assets less current liabilities
Positive outcomes were reported for CAN-2409 in pancreatic cancer, showing prolonged and sustained survival, robust immune response activation, and a favorable tolerability profile. For CAN-3110 in high-grade glioma, extended survival associated with immune activation was observed.
Candel received FDA Fast Track Designations for CAN-2409 for non-small cell lung cancer, borderline resectable pancreatic cancer, and CAN-3110 for recurrent high-grade glioma.
Candel anticipates six data readouts in 2024 across its three platforms, including novel clinical and biomarker data in lung cancer, pancreatic cancer, and brain cancer, as well as a potentially registrational phase 3 clinical trial in prostate cancer.
Research and development expenses increased in Q4 2023 due to activities supporting the CAN-2409 programs, including manufacturing and regulatory activities, stock compensation costs, and impairment of fixed assets.
