On November 13, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported positive data from the EFTISARC-NEO trial that were detailed in an oral presentation by Paweł Sobczuk, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting held in Boca Raton, Florida.

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The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) significantly exceeded the study’s prespecified level of pathologic response rates. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001), meeting the study’s primary endpoint.1

These promising results were achieved in patients with ten different STS subtypes including rare and/or highly aggressive tumours with poor prognosis such as myxofibrosarcoma (N=16), undifferentiated pleomorphic sarcoma (N=10) and malignant peripheral nerve sheath tumor (N=2).

Early translational data from the initial twenty patients who underwent surgery in the trial show a strong immune system activation in line with efti’s mode of action, with statistically significant increases in the expression of key cytokines and chemokines in peripheral blood — specifically CXCL9, CXCL10, IL-23, and IFN-g.

Immune Response Biomarkers (fold change from week 1 through pre-surgery)

Serum Biomarker Fold change (p-value)
C-X-C motif chemokine ligand 9 (CXCL9)

2.5x (p<0.01)
C-X-C motif chemokine ligand 10 (CXCL10)

1.8x (p<0.0001)
Interleukin-23 (IL-23)

2.2x (p<0.05)
Interferon-gamma (IFN-g)

2.5x (p<0.05)
The increase on treatment of immune response biomarkers like IFN-gamma correlated with pathologic responses in this study, meaning patients with a biomarker increase during treatment also had a higher probability of a good clinical response at surgery.

The promising tumour hylanization/fibrosis rate achieved (over 3X greater than standard-of-care radiotherapy based on historical data)1 may hold significance in terms of future outcomes as it serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients.2,3 Disease-free survival and overall survival data are immature at this stage and will be presented in the future. Further correlative translational studies are also ongoing.

Dr. Paweł Sobczuk, one of the trial’s principal investigators, stated: "We are excited to share these strong results in resectable soft tissue sarcoma, a challenging indication with a high unmet medical need. This level of efficacy, observed across ten different STS subtypes including rare, highly aggressive tumours with poor prognosis, further supports the hypothesis that efti’s distinctive activation of antigen-presenting cells—and consequent induction of both adaptive and innate immunity—plays a key role in driving a coordinated immune response to fight cancer. This novel combination with neoadjuvant efti warrants further investigation in registrational settings."

"Our team was delighted to have recently been awarded the distinguished Golden Scalpel Award (Złoty Skalpel)* for EFTISARC-NEO. This honour is reserved for projects that demonstrate exceptional innovation and impact in medical research and clinical practice," added Dr. Sobczuk.

Dr. Frédéric Triebel, CSO of Immutep, said: "We are pleased to see a confirmation of earlier promising data on now 38 patients in this difficult-to-treat cancer. The prolonged increase in serum immune response biomarkers, observed two weeks after efti subcutaneous injection, is indicative of a robust adaptive and innate immune response. This enhanced immune activity is crucial because it means the body’s own defences are being mobilised to target and destroy cancer cells more effectively, further supporting the positive impact of the observed pathologic responses. The recent results suggest that efti may have potential applications beyond advanced or metastatic cancer, extending into earlier-stage disease."

As neoadjuvant immunotherapy becomes more established in the treatment of early-stage cancers, the findings from EFTISARC-NEO highlight the possibility for efti to be used in patients who have a lower tumor burden at diagnosis. This could expand the range of patients who might benefit from efti, potentially increasing its role in the treatment landscape for cancers that are still localized and resectable.

STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.4

For more information on EFTISARC-NEO, visit clinicaltrials.gov (NCT06128863). The CTOS 2025 oral presentation slides can be found on the Posters & Publications page of Immutep’s website.

*About the Golden Scalpel Award in Poland

The Golden Scalpel Award in Poland is recognized as a benchmark of excellence within the medical community. It is presented by independent experts to initiatives that set new standards in advancing healthcare. This year, EFTISARC NEO was the only oncology project to receive this accolade, underscoring its leadership and breakthrough potential in cancer treatment.

About Eftilagimod Alfa (Efti)

Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, NOV 13, 2025, View Source [SID1234659971])

On November 13, 2025 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported financial results for the third quarter ended September 30, 2025, and provided recent business highlights.

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"In the third quarter, we remained focused on clinical execution in both our global Phase 3 CoMpass trial in early choroidal melanoma and our Phase 1b/2 trial in NMIBC," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura Biosciences. "Enrollment has taken longer than we expected in early choroidal melanoma due to the requirement to document active tumor growth prior to patient enrollment and other unique enrollment challenges with the first Phase 3 trial in this rare indication. In 2025, we implemented measures to address these operational challenges and have experienced improved enrollment in recent months. We believe we are now in a position to provide guidance regarding the topline data readout for the study."

"Our NMIBC trial remains on track, with data expected in mid-2026. Recently presented Phase 1 trial immune profiling data reinforce bel-sar’s distinct dual mechanism, driving focal anti-tumor immune activation. We believe these findings highlight bel-sar’s potential as a differentiated frontline, organ-preserving treatment to deliver durable responses across the bladder cancer spectrum and in other solid tumors."

Recent Pipeline Developments

Early Choroidal Melanoma

Ongoing Phase 3 CoMpass Trial: CoMpass is the first registration-enabling trial in early choroidal melanoma. The trial is a global, Phase 3, randomized trial evaluating bel-sar treatment against a sham control arm utilizing an enrichment strategy to enroll approximately 100 patients with documented tumor growth. We believe the study enrollment has been slower than expected due to the operational challenges of implementing the first Phase 3 trial in this rare indication across global sites and the requirement of active growth in our inclusion criteria, which often requires sites to follow patients for variable periods of time until they demonstrate required growth.

Approximately 90% of targeted clinical sites are now activated, and we have implemented measures to address multiple operational challenges. Our patient identification tool has shown strong growth, with more than 400 patients having been entered since June 2024, and the current number of potentially eligible patients having increased to 280. We believe this highlights the enrollment opportunity and the significant unmet need.

Based on trial activity in recent months and the growing number of potentially eligible patients, the Company currently expects that it can complete CoMpass enrollment in 2026 and provide topline data readout for the 15-month primary endpoint in the fourth quarter of 2027. This estimate assumes enrollment rates that are generally consistent with the rates experienced in recent months.

Currently, there are no approved vision-preserving therapies for patients with early choroidal melanoma. The standard of care remains radiotherapy, which frequently results in irreversible vision loss. Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. The Company previously received Orphan Drug Designation from the FDA and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA.

Bladder Cancer

Additional Phase 1 Biological Activity Data Presented at the 45th Congress of the Société Internationale d’Urologie (SIU): Multiplex immune fluorescence data from the Phase 1 trial of bel-sar demonstrating robust induction of adaptive immune memory in patients with non-muscle invasive bladder cancer (NMIBC) were presented by Seth P. Lerner, M.D., Professor of Urology at Baylor College of Medicine at SIU, held October 29–November 1, 2025, in Edinburgh, United Kingdom: link. These multiplex immune fluorescence data (n=5 patients from the Phase 1 trial) further characterize the previously announced results from the Company’s completed Phase 1 clinical trial of bel-sar in patients with NMIBC.

These data revealed that a single focal administration of bel-sar induced adaptive immune memory through generation of de novo mature tertiary lymphoid structures (TLS) in 3/5 participants evaluated. Bel-sar also generated innate and adaptive effectors regardless of immune environment and converted immune-cold or exhausted lesions into active, immune-hot microenvironments. In treated lesions, natural killer cell density increased up to 40x, CD4+ cytolytic T cell density increased up to 7x, and CD4+ and CD8+ memory T cells were observed after bel-sar treatment.

This biological activity profile reinforces bel-sar’s potential as a frontline therapy designed to treat the tumor, activate durable anti-tumor immunity, and reduce recurrence risk across the bladder cancer spectrum.

Ongoing Phase 1b/2 Trial: This trial will evaluate additional doses and cycles of bel-sar in approximately 26 intermediate and high-risk NMIBC patients. Patients will be monitored for response assessments and recurrence at 3, 6, 9, and 12 months. This trial is actively enrolling and remains on track, with initial three-month clinical data expected in mid-2026.

Metastases to the Choroid

The Company has dosed the first patient in an ongoing Phase 2 clinical trial in metastases to the choroid. A protocol amendment has now been implemented to expand the entry criteria to include all metastases arising from different solid tumors to facilitate enrollment into the study and broaden the proof of concept for bel-sar in this indication. This approach is supported by preclinical models that demonstrate robust efficacy across multiple primary solid tumors. The Company is evaluating further expansion of the inclusion criteria for this trial to address the high unmet medical need. With a four-week efficacy endpoint, the Company expects early proof of concept data from this trial in 2026.

Metastases to the choroid is an indication with high unmet medical need and no approved therapies with an incidence of 20,000 patients annually in the United States and Europe. Bel-sar has the potential to treat a wide variety of tumor types in the choroid that metastasize from various primary tumors. The Company previously received FDA Fast Track designation for bel-sar in this indication.

Cancers of the Ocular Surface

The Company is planning to initiate a Phase 1 proof-of-concept trial to assess safety, feasibility and tumor response through histopathologic evaluation at a 2–4-week time point. Development activities for this program remain on track, with early proof of concept data from Australian clinical sites expected in 2026.

Cancers of the ocular surface affect approximately 35,000 patients in the United States and Europe annually and are associated with a particularly high incidence in regions such as Australia. There are currently no approved therapies for these tumors.

Third Quarter 2025 Financial Results

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As of September 30, 2025, the Company had cash and cash equivalents and marketable securities totaling $161.9 million. The Company believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the first half of 2027. The Company remains focused on driving a cash-efficient operation to deliver data across its pipeline.

•
Research and development expenses increased to $22.2 million for the three months ended September 30, 2025 from $17.0 million for the three months ended September 30, 2024, primarily due to ongoing clinical and clinical research organization (CRO) costs associated with the progression of our global Phase 3 trial of bel-sar in early choroidal melanoma and higher personnel expenses related to growth of our Company.

•
General and administrative expenses decreased to $5.7 million for the three months ended September 30, 2025 from $6.2 million for the three months ended September 30, 2024. General and administrative expenses include $1.7 million and $1.6 million of stock-based compensation for the three months ended September 30, 2025 and 2024, respectively. The decrease was primarily driven by reduced professional fees.

•
Net loss for the three months ended September 30, 2025 was $26.1 million compared to $21.0 million for the three months ended September 30, 2024.

(Press release, Aura Biosciences, NOV 13, 2025, View Source [SID1234659892])

On November 13, 2025 Monopar Therapeutics Inc. ("Monopar" or the "Company") (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, reported third quarter 2025 financial results and recent developments.

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Recent Developments

ALXN1840 for Wilson Disease

On September 14-15, 2025, the Company presented new data on the long-term neurological efficacy and safety of ALXN1840 (tiomolybdate choline) at the 150th American Neurological Association (ANA) Annual Meeting. Matthew Lorincz, M.D., Ph.D., Professor of Neurology and Co-Director of the Wilson Disease Center of Excellence at the University of Michigan delivered the poster and oral presentations. The new findings presented at ANA highlight the long-term neurological benefit of ALXN1840, and follow the European Association for the Study of the Liver (EASL) International Liver Congress presentation in May on the long-term hepatic and systemic safety and efficacy data. Together, these findings underscore the potential of ALXN1840 to favorably impact both neurological and hepatic manifestations of Wilson disease.

On November 9, 2025, the Company presented new data and analyses from the Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting 2025. In an oral presentation titled "Rapidly Improved Cu Balance in Wilson Disease Patients on Tiomolybdate Choline," Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., Professor of Hepatology and Consultant Hepatologist at the Institute of Liver Studies at King’s College Hospital in London, shared results showing that treatment with ALXN1840 led to a rapid and sustained improvement in daily copper balance in patients with Wilson disease, primarily through increased fecal copper excretion.

Monopar is preparing to submit a New Drug Application ("NDA") to the FDA in early 2026.

MNPR‐101 for Radiopharmaceutical Use

On September 26, 2025, Monopar received FDA clearance on its IND application for MNPR-101-Lu, which covers the protocol titled "Phase 1, Open-Label, Multicenter, Dosimetry and Dose-Escalation Trial to Characterize the Safety, Tolerability, and Anti-Tumor Activity of Fractionated MNPR-101-Lu Dosing in the Treatment of uPAR-Expressing Advanced or Metastatic Solid Tumors." This IND incorporates the Company’s proprietary linker technology, which has been designed to enhance the stability and biodistribution of its therapeutic radiopharmaceuticals.

Recent Financing Capital Raise and Share Repurchase

On September 23, 2025, the Company priced an underwritten public offering (the "Offering") consisting of (i) 1,034,433 shares of its common stock and (ii) pre-funded warrants to purchase 960,542 shares of common stock, pursuant to an underwriting agreement (the "Underwriting Agreement") with Morgan Stanley & Co. LLC, Leerink Partners LLC, and Barclays Capital Inc. (the "Underwriters"). The public offering price was $67.67 per share and $67.669 per pre-funded warrant, which represents the per share offering price less a $0.001 per share exercise price. The aggregate net proceeds from the Offering were approximately $126.9 million, after deducting underwriting discounts and commissions but before offering expenses and the Share Repurchase (as defined below).

On September 24, 2025, the Company entered into a share purchase agreement (the "Share Purchase Agreement") with Tactic Pharma LLC ("Tactic Pharma"), an existing significant stockholder that held approximately 13.4% of the Company’s common stock prior to the Offering and Share Repurchase. Pursuant to the Share Purchase Agreement, the Company used $35 million of the Offering proceeds to repurchase 550,229 shares of its common stock from Tactic Pharma at a purchase price of $63.6098 per share, which equals the public offering price per share less underwriting discounts and commissions (the "Share Repurchase"). After giving effect to the Share Repurchase, the Company’s net proceeds from the Offering were approximately $91.9 million, before estimated offering expenses.

Financial Results for the Third Quarter Ended September 30, 2025, Compared to the Third Quarter Ended September 30, 2024

Cash and Net Loss

Cash, cash equivalents and investments as of September 30, 2025, were $143.7 million. Monopar expects that its current funds will be sufficient to continue operations at least through December 31, 2027, in order to: (1) assemble a regulatory package and file an NDA for the ALXN1840 investigational drug candidate for Wilson disease; (2) continue to conduct and conclude our first-in-human imaging and dosimetry clinical trial with MNPR-101-Zr, continue to conduct our first-in-human therapeutic clinical trial of MNPR-101-Lu, and advance our preclinical MNPR-101-Ac program into the clinic; and (3) invest in internal R&D projects to expand our radiopharmaceutical pipeline.

Net loss for the third quarter of 2025 was $3.4 million or $0.48 per share compared to net loss of $1.3 million or $0.37 per share for the third quarter of 2024.

Research and Development ("R&D") Expenses

R&D expenses for the third quarter of 2025 were $2,589,749, compared to $984,278 for the third quarter of 2024. This represents an increase of $1,605,471 attributed to (1) a $937,582 increase in manufacturing activities related to ALXN1840, (2) a $617,667 increase in R&D personnel expenses including stock-based compensation and (3) a net increase of $50,223 in other R&D expenses.

General and Administrative ("G&A") Expenses

G&A expenses for the third quarter of 2025 were $1,503,326, compared to $590,624 for the third quarter of 2024. This represents an increase of $912,702 primarily attributed to (1) a $369,959 increase in Board compensation resulting from the grant of stock options in March 2025 (no stock options were granted to the Board in 2024), (2) a $287,749 increase in G&A personnel expenses including stock-based compensation, and (3) a net increase of $254,993 in other G&A expenses.

Interest Income

Interest income for the third quarter of 2025 increased by $556,129 compared to the same period in 2024. The increase is attributed to interest earned on U.S. Treasury securities and higher bank balances in 2025, as a result of the approximately $91.9 million raised in the Offering after giving effect to the Share Repurchase, deducting underwriting discounts and commissions but before offering expenses.

(Press release, Monopar Therapeutics, NOV 13, 2025, View Source [SID1234659908])

On November 13, 2025 PAVmed Inc. (NASDAQ: PAVM) ("PAVmed" or the "Company"), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, reported a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (NASDAQ: LUCD) ("Lucid") and Veris Health Inc. ("Veris"), and reported financial results for the quarter ended September 30, 2025.

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Conference Call and Webcast

The webcast will take place on Thursday, November 13, 2025, at 8:30 AM and is accessible in the investor relations section of the Company’s website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "PAVmed Business Update" to join.

Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company’s website at pavmed.com.

Business Update Highlights

"Over the past 18 months, we have taken decisive steps to stabilize PAVmed’s corporate structure and strengthen its balance sheet, and we believe we are entering the final stages of that process," said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. "As our subsidiaries continue to execute and advance toward major milestones, we expect PAVmed to benefit directly from their success. Veris is progressing toward FDA submission of its implantable physiological monitor, expanding its partnership with OSU-The James, and developing new value-add capabilities beyond remote patient monitoring. Lucid remains firmly on track as it approaches transformative Medicare coverage for EsoGuard, supported by a strengthened balance sheet, continued commercial execution, and a new world-class market access team driving payor engagement. We also signed a letter of intent with Duke University to license a promising endoscopic imaging technology, adding another potential growth engine to our innovation pipeline."

Highlights from the third quarter and recent weeks:

Veris launched commercial phase of strategic partnership with The Ohio State University James Cancer Hospital, advancing deployment of the Veris Cancer Care Platform.
Veris fully relaunched implantable physiological monitor development in preparation for a planned 2026 FDA 510(k) submission.
Veris completed a long-term strategic partnership with The Ohio State’s James Cancer Hospital. Integration with the hospital’s electronic health record (EHR) system is now in process, with full commercial deployment of the Veris Cancer Care Platform to commence thereafter.
Veris continued executing on its expanded vision, focusing on commercial expansion and value-add offerings beyond remote patient monitoring (RPM), including clinical support services and AI-based clinical decision tools such as risk stratification.
PAVmed signed a letter of intent to license, through a newly formed subsidiary, groundbreaking endoscopic esophageal imaging technology, as it continues to evaluate new opportunities to leverage its shared services model across diverse sectors.
Lucid Diagnostics announced third quarter 2025 financial results and key business developments, including:
Recognized $1.2 million in EsoGuard Esophageal DNA Test revenue for 3Q25 and processed 2,841 EsoGuard tests.
Medicare Contractor Advisory Committee (CAC) meeting held where medical experts unanimously supported Medicare coverage for EsoGuard.
Strengthened balance sheet with underwritten public offering of common stock, netting approximately $27.0 million in proceeds.
Recruited world-class market access team focused on payor engagement, broad insurance coverage, and patient access.
Financial Results:

For the three months ended September 30, 2025, Operating expenses were approximately $4.8 million which include stock-based compensation expenses of $0.4 million. GAAP net loss attributable to common stockholders was approximately $6.3 million, or $(0.29) per common share on a diluted basis.
As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company’s financial results, the Company’s non-GAAP adjusted loss was approximately $0.4 million or $(0.02) per common share.
PAVmed had cash and cash equivalents of $3.1 million as of September 30, 2025, compared to $1.2 million as of December 31, 2024.
The unaudited financial results for the three and nine months ended September 30, 2025 were filed with the SEC on Form 10-Q on November 12, 2025, and are available at www.pavmed.com or www.sec.gov.

(Press release, PAVmed, NOV 13, 2025, View Source [SID1234659937])

On November 13, 2025 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, reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

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"This quarter we continued to make strong progress across our clinical pipeline," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. "We continue to work toward a planned BLA submission in Q4 2026. We presented additional supportive data from our positive phase 3 trial of CAN-2409 in newly diagnosed, localized prostate cancer during an oral presentation at the Association of Radiation Oncology (ASTRO) Annual Meeting, demonstrating that CAN-2409 improved prostate cancer-specific DFS, independent of the type of external beam radiation therapy used, extending the results presented during an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. We also presented data during an invited lecture at the Annual Meeting of the Prostate Cancer Foundation. We continue to follow the patients enrolled in the phase 3 study for prostate cancer-specific outcomes and expect the first results after extended follow-up in Q2 2026. In addition, in collaboration with the U.S. Food and Drug Administration, we designed a supportive, mechanistic clinical trial of CAN-2409 in localized prostate cancer. We plan to release immunologic biomarker data from this study in Q3 2026. Furthermore, we reported encouraging survival data from our phase 1b clinical trial of CAN-3110 in patients with rHGG, most of whom had recurrent glioblastoma, supported by sophisticated brain biopsy analyses. Mature overall survival data for Arm C are expected in Q4 2026. Together, the data supports the design of a randomized controlled phase 2 clinical trial of CAN-3110 in recurrent glioblastoma. Finally, we strengthened our Research Advisory Board with the appointments of Dr. Carl H. June and Dr. Bali Pulendran, underscoring our continuous commitment to scientific excellence and to advancing immunotherapies that may meaningfully improve the lives of patients with devastating cancers."

Dr. Tak continued, "On the financial front, we were pleased to secure strategic, non-dilutive funding through a five-year, $130 million term loan facility with Trinity Capital, Inc., which strengthens our balance sheet and positions us to advance our key priorities, including the initiation of a pivotal phase 3 clinical trial of CAN-2409 in NSCLC and the potential commercial launch of CAN-2409 in localized prostate cancer. We expect updated data on long-term survivors from our phase 2 study in NSCLC in Q1 2026 and anticipate initiation of the phase 3 study in Q2 2026. We look forward to sharing more details on our progress and strategic vision at our virtual Research and Development event in Q4 2025."

Third Quarter 2025 & Recent Highlights

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CAN-2409 (aglatimagene besadenovec) – Prostate Cancer
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In an oral presentation at the 2025 ASTRO Annual Meeting, the Company presented subgroup analyses focused on the radiation regimen used during its positive phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer. Data were presented by Glen Gejerman, M.D., M.B.A., Co-Director of Urologic Oncology at Hackensack Meridian Health and one of the principal investigators of the study.

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CAN-2409 demonstrated statistically significant improvement in prostate cancer-specific DFS (Hazard Ratio (HR) 0.62; p=0.0046). Effects were observed with both moderate hypo-fractionated external beam radiation therapy (EBRT) (HR 0.52, CI 0.30 – 0.93, p=0.0236) and conventional EBRT (HR 0.76, CI 0.53 – 1.07, p=0.1131).
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CAN-2409 administration was safe across radiation therapy modalities, with both conventional radiation therapy (~78 Gy in 2 Gy fractions, ~72% of patients) and moderate hypofractionated radiation therapy (60 Gy in 3 Gy fractions, ~25% of patients), showing similar tolerability profiles. Grade ≥ 3 treatment related adverse events were similar in the CAN-2409 plus valacyclovir and placebo arms with both hypofractionated (1.6% vs. 1.9%) and standard EBRT (1.8% vs. 1.1%), respectively.
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The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to CAN-2409 for the treatment of prostate cancer; the phase 3 clinical trial of CAN-2409 in localized prostate cancer was conducted under a Special Protocol Assessment agreed to with the FDA.
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The Company is advancing its pre-BLA readiness, including through its Chemistry, Manufacturing, and Controls (CMC) activities, and preparation of clinical study reports and BLA modules.
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CAN-2409 – Non-Small Cell Lung Cancer (NSCLC)
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Following a positive end-of-phase 2 meeting with the FDA in July 2025, the Company is preparing to initiate a pivotal phase 3 clinical trial of CAN-2409 in NSCLC in Q2 2026.
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The FDA previously granted Fast Track Designation to CAN-2409 for the treatment of NSCLC.
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CAN-2409 – Pancreatic Cancer
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The Company previously generated encouraging data based on a randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable pancreatic cancer (PDAC). The FDA previously granted Fast Track Designation and Orphan Drug Designation to CAN-2409 for the treatment of PDAC and the European Medicines Agency granted Orphan Designation for CAN-2409 for the treatment of pancreatic cancer in July 2025.
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With Candel’s top priorities focused on prostate cancer and NSCLC, the Company will pause the PDAC program, unless it is funded through external, non-dilutive funding.
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CAN-3110 (linoserpaturev) – Recurrent High-Grade Glioma (rHGG)

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In October 2025, the Company reported encouraging updated survival data for all patients enrolled in its phase 1b clinical trial of CAN-3110 in rHGG:
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Updated median overall survival (mOS) was 11.8 months (CI: 8.3–14.9) for arm A (n = 41) and 12.0 months (CI: 10.0–NA) for arm B (n = 9) after a single injection of CAN-3110, consistent with previously reported data for arms A and B. At the time of data cutoff (August 15, 2025), one patient from arm A and one patient from arm B were still alive after prolonged follow-up (59.2 and 42.4 months, respectively, after CAN-3110 administration). The FDA previously granted Fast Track Designation and Orphan Drug Designation to CAN-3110 in recurrent high-grade glioma based on an earlier data cut.
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At data cutoff as of August 15, 2025, 9 patients in arm C had received multiple administrations of CAN-3110. At the 1×10⁸ PFU dose, 3 patients received 4 injections, 1 patient received 5 injections, and 2 patients received 6 injections. At the 1×10⁷ PFU dose, 1 patient received 4 injections, and 2 patients received 5 injections. Median follow-up was 8.9 months. Four out of 9 patients were alive at time of data cutoff (range 3.1-28.2 months after initiation of CAN-3110 treatment). Five patients had died, of which 3 died more than one year after initiation of CAN-3110 treatment (range 5.5-21.8 months).
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Candel also announced the scientific publication, "Serial Multiomics Uncovers Anti-Glioblastoma Responses Not Evident by Routine Clinical Analyses," in the journal Science Translational Medicine. Led by E. Antonio Chiocca, M.D., Ph.D., Executive Director of the Center for Tumors of the Nervous System at the Mass General Brigham Cancer Institute, as part of the multi-institutional Break Through Cancer Accelerating GBM Therapies Through Serial Biopsies TeamLab, the publication presents findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of CAN-3110 in arm C of the ongoing phase 1b clinical trial (NCT03152318).
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Together, the encouraging data supports the Company’s plans to design a randomized controlled phase 2 clinical trial of CAN-3110 in recurrent glioblastoma.
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Recent Corporate Events
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The Company presented insights into the third preclinical candidate from its enLIGHTEN Discovery Platform in a mouse model of breast cancer, as well as additional data from the CAN-2409 program in NSCLC, through two accepted poster presentations, along with an invited faculty presentation and panel discussion by Paul Peter Tak, M.D., Ph.D., FMedSci, Candel’s President and CEO, showcasing the phase 3 clinical trial of CAN-2409 in newly diagnosed, localized prostate cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting.

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In October 2025, Candel entered into a $130 million term loan facility with Trinity Capital Inc. (Nasdaq: TRIN). The loan facility consists of four tranches, with the first tranche of $50 million drawn upon closing of the agreement. The second and third tranches totaling $50 million in the aggregate are available to be drawn subject to the achievement of certain regulatory, clinical and operational milestones, subject to certain conditions precedent described in the agreement, and the fourth tranche of $30 million is available at the lender’s discretion. The loan facility has a five-year term with an interest-only period of 36 months, which is extendable for an additional 12 months upon the achievement of a certain commercial milestone. The loan facility contains customary representations, warranties, covenants, and events of default.
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In September 2025, the Company appointed Carl H. June, M.D., to its Research Advisory Board (RAB). Dr. June is an internationally recognized expert in cancer immunotherapy, and a pioneer in developing the first FDA-approved CAR-T cell therapy.
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In October 2025, the Company appointed Bali Pulendran, Ph.D., to its RAB. Dr. Pulendran is an internationally recognized expert in systems immunology and vaccinology, who has pioneered the use of systems’ approaches to understand human immune responses.
Anticipated Milestones

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Candel will host a Virtual R&D Day on Friday, December 5, 2025.
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Updated mOS data and "long tail" of survival analysis from the phase 2a open-label clinical trial of CAN-2409 in patients with stage III/IV NSCLC who had progressed, despite ICI treatment (NCT04495153) is expected in Q1 2026.
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Updated data on prostate cancer-specific DFS, time to salvage anti-cancer therapy, and time to metastasis from the positive phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer after extended follow-up is expected in Q2 2026.
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The Company plans to initiate a pivotal phase 3 clinical trial of CAN-2409 in NSCLC in Q2 2026.
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Data on local and systemic biomarkers of immune activation from a mechanistic, supportive clinical trial of CAN-2409 in patients with localized prostate cancer, is expected in Q3 2026.
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The Company expects to present mature mOS data and an update on long-term survivors from arm C of its phase 1b clinical trial of CAN-3110 in patients with recurrent glioblastoma in Q4 2026.
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Submission of BLA for CAN-2409 in prostate cancer is expected in Q4 2026.

Financial Results for the Third Quarter Ended September 30, 2025

Research and Development Expenses: Research and development expenses were $8.5 million for the third quarter of 2025 compared to $5.4 million for the third quarter of 2024. The increase was primarily due to an increase in manufacturing and regulatory costs, in support of the Company’s CAN-2409 programs, and an increase in employee-related expenses, as well as an increase in depreciation and loss on the disposal and sale of fixed assets. Research and development expenses included a non-cash stock compensation expense of $0.5 million for the third quarter of 2025 compared to a non-cash stock compensation expense of $0.6 million for the third quarter of 2024.

General and Administrative Expenses: General and administrative expenses were $4.7 million for the third quarter of 2025, compared to $3.3 million for the third quarter of 2024. The increase was primarily due to an increase in commercial readiness costs as well as an increase in employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $0.6 million for the third quarter of 2025 compared to $0.5 million for the third quarter of 2024.

Net Loss: Net loss for the third quarter of 2025 was $11.3 million compared to a net loss of $10.6 million for the third quarter of 2024 and included net other income of $1.9 million and net other expense of $1.9 million, respectively. The change from net other expense in 2024 to net other income in 2025 was primarily related to the change in the fair value of the Company’s warrant liability and an increase in interest income.

Cash Position: Cash and cash equivalents, as of September 30, 2025, were $87.0 million compared to $102.7 million as of December 31, 2024. Based on current operating plans, including the initiation of a potentially registrational phase 3 trial in NSCLC, the Company expects that its existing cash and cash equivalents, as of September 30, 2025, together with proceeds from the upfront tranche of the Trinity debt facility, will be sufficient to fund operations into Q1 2027.

About CAN-2409

CAN-2409 (aglatimagene besadenovec), 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 protein promotes 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. CAN-2409 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 CAN-2409 in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.

About CAN-3110

CAN-3110 (linoserpaturev) is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) next-generation oncolytic viral 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 CAN-3110 was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved mOS compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation.

About the enLIGHTEN Discovery Platform

The enLIGHTEN Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These characteristics are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations.

(Press release, Candel Therapeutics, NOV 13, 2025, View Source [SID1234659893])