On September 30, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported an update on recent advances in its proprietary Drug Response Predictor (DRP) technology, patent portfolio and in-house laboratory capabilities that strengthen its ability to drive stenoparib’s clinical development while expanding external partnership opportunities.

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Allarity Therapeutics was established on its proprietary patient selection technology—the Drug Response Predictor (DRP). DRP allows Allarity to assess a patient’s tumor tissue for the gene expression changes that indicate the patient’s tumor is either more or less likely to respond to a given cancer therapy. DRP tests have been successfully developed for dozens of cancer therapies. Most notably, DRP has been developed for Allarity’s lead asset, stenoparib, and has been deployed in the clinic to pre-select patients for stenoparib-based therapy.

The stenoparib-DRP is comprised of a unique 414-gene expression signature, notably including genes associated with WNT pathway activity. At AACR (Free AACR Whitepaper) 2026, Allarity presented an exploratory analysis of its prior Phase 2 cohort of patients with advanced ovarian cancer treated with twice-daily stenoparib. Higher pretreatment DRP scores were associated with longer overall survival, supporting the test’s potential to identify patients who may derive the most durable benefit.

Recent patent awards coupled with the CLIA certification of Allarity’s in-house lab allow the company to extend the utility of the test as a companion diagnostic test and to retain sole control of that clinical test. These developments extend the commercial viability of both stenoparib and the stenoparib-DRP test.

Collectively, these advances support Allarity’s ongoing strategy to use DRP to inform patient selection for a pivotal trial, making the technology an integral part of stenoparib’s development toward FDA approval.

"Over the past few months, we have significantly strengthened the clinical foundation for our DRP-guided stenoparib program," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. "For stenoparib, the association between higher DRP scores and longer overall survival helps inform our clinical development strategy as we work toward FDA approval. While stenoparib remains our principal development focus, our extensive experience developing predictors for other drugs also provides a foundation for external partnerships."

(Press release, Allarity Therapeutics, SEP 30, 2026, View Source [SID1234671190])

On September 30, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, reported novel immunological biomarker data from the ongoing phase 2 PrTK05 trial (NCT07332000) in patients with intermediate-risk localized prostate cancer. These data, together with histologic and clinical data from the intermediate-risk prostate cancer subgroup of the PrTK03 phase 3 trial (NCT01436968) (635 patients, 85% of the intention-to-treat population), are expected to be presented at a future scientific meeting. Intermediate-risk prostate cancer represents the largest group of patients with localized disease treated with curative-intent external beam radiation therapy (EBRT), accounting for approximately 65,000 patients annually in the United States. Despite radiotherapy, disease recurrence, local and metastatic progression, and the need for salvage anti-cancer therapies that can be associated with substantial toxicity and impaired quality of life remain important unmet needs. This underscores the need for new treatments designed to enhance local tumor control and reduce the risk of disease progression.

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PrTK03 Clinical Outcomes

With follow-up through March 15, 2026 (median, 58.0 months), the phase 3 trial showed that patients with intermediate-risk disease (635 patients) treated with aglatimagene plus EBRT experienced a 41% reduction in the risk of prostate cancer recurrence or prostate cancer-specific death versus placebo plus EBRT (HR 0.59; 95% CI 0.41–0.84; p=0.0034).

Additional exploratory, descriptive analyses showed 52% improvement in the time to biochemical failure (HR 0.48; 95% CI 0.22–1.03), a 90% improvement in the time to metastasis (HR=0.10; 95% CI 0.01–0.85), and a 49% reduction in the time to salvage anticancer therapy (HR 0.51; 95% CI 0.24–1.10).

PrTK03 Pathologic and Biomarker Data

Centrally reviewed biopsies from patients with intermediate-risk disease obtained 22–26 months after treatment demonstrated a substantial improvement in rate of negative biopsies, defined as the absence of tumor cells in a standard-of-care diagnostic prostate biopsy. Among 277 evaluable patients with intermediate-risk disease:

76.6% (144/188) in the aglatimagene arm had negative biopsies versus 60.7% (54/89) in the control arm
Positive biopsies were observed in 20.7% of the aglatimagene arm and 38.2% of the control arm (stratified CMH p = 0.0034; chi-square p = 0.0026). Six undetermined biopsies were included in the total number of biopsies analyzed and are part of the denominator.
Building on the AI-enabled histologic analysis presented at ASTRO, exploratory digital pathology analyses showed:

Increased lymphocytic infiltration after treatment in both arms (p<0.001)
In paired biopsies with detectable post-treatment tumor (n=98), aglatimagene increased the intratumoral lymphocyte fraction (p=0.002) and lymphocyte–tumor enrichment and mixing scores (both p<0.001)
These immune changes were observed more than two years after treatment.

PrTK05 Systemic Immune Response Data

Early data from the PrTK05 flow-cytometry analyses provided evidence that local treatment with aglatimagene is associated with systemic expansion and activation of multiple circulating cytotoxic T-cell populations. Serial blood samples from 13 patients with intermediate-risk prostate cancer, treated with aglatimagene plus standard-of-care (SoC) EBRT, and 6 patients receiving SoC alone showed expansion of CD8-positive effector and effector-memory T cell populations in the aglatimagene arm, alongside expansion of Ki67-positive proliferating and granzyme B-positive cytotoxic CD8-positive T-cells. These longitudinal findings extend the local PrTK03 tissue observations by suggesting a coordinated systemic immune response beyond the locally treated prostate; formal comparison with SoC-treated controls is ongoing.

Together, these analyses provide complementary evidence of durable local tumor clearance and immune remodeling within the prostate, along with systemic expansion and activation of cytotoxic T-cell populations beyond the treated tumor.

"This signature of coordinated immune activation across tissue and blood in prostate cancer is consistent with findings previously observed following aglatimagene treatment in other solid tumor indications, including NSCLC and high-grade glioma," said Francesca Barone, M.D., Ph.D., Chief Scientific Officer of Candel Therapeutics. "These findings are consistent with a shared mechanism across solid tumors involving immunogenic tumor cell death followed by individualized local and systemic anti-tumor immunity that does not depend on a predefined antigen or biomarker."

Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics, added, "The evidence of systemic immune activation in intermediate-risk prostate cancer strengthens the biological rationale for evaluating aglatimagene in metastatic solid tumor settings where systemic disease control is critical. These findings underscore the broader potential of our multimodal immunotherapy platform."

The biodistribution and shedding data from the phase 2 PrTK05 trial have been compiled for inclusion in Candel’s BLA for aglatimagene in localized prostate cancer, which the Company plans to submit to the FDA in Q4 2026. The Company intends to submit the data for presentation at an upcoming scientific conference and for potential publication in a peer-reviewed journal in 2027.

About aglatimagene besadenovec

Aglatimagene besadenovec (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 nonclinical 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.

(Press release, Candel Therapeutics, SEP 30, 2026, View Source [SID1234671189])

On September 30, 2026 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that detailed analysis of results from the VIRAGE Phase 2b clinical trial of VCN-01 (zabilugene almadenorepvec) in metastatic pancreatic cancer patients were published in Nature Medicine. The article, entitled "Intravenous hyaluronidase-expressing oncolytic adenovirus with chemotherapy in metastatic pancreatic cancer: a randomised phase 2b trial", can be read here.

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"We are proud to see the peer-reviewed results from the VIRAGE trial published in Nature Medicine and made available to the entire scientific community," said Manel Cascalló, PhD, General Director of Theriva Biologics S.L. and co-author of the article. "As elaborated in the publication, improved overall survival, progression free survival, and duration of response were observed in metastatic pancreatic cancer patients treated with VCN-01 combined with standard-of-care (SoC) gemcitabine/nab-paclitaxel chemotherapy compared to patients receiving SoC chemotherapy alone. Moreover, the Kaplan-Meier survival analysis and the timing of responses in VCN-01 treated patients suggest an immune mediated mechanism of action for VCN-01 in addition to its stroma degrading effects. We are excited about the potential for VCN-01 in different cancer therapy combinations, and we are extremely grateful to the patients who participated in VIRAGE, their families, our clinical investigators and their teams, and our co-authors for their commitment, dedication and diligence."

As previously reported, greater improvements in patient survival during the VIRAGE study were observed in metastatic pancreatic cancer patients receiving 2 doses of VCN-01 administered 3 months apart, Following End-of-Phase 2 feedback from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), Theriva has recently initiated VIRAGE2; a small Phase 2a study designed to evaluate the feasibility of more frequent, repeated dosing of VCN-01 in combination with SoC chemotherapy. The first patient in VIRAGE2 was treated in August 2026, and the study is expected to complete enrollment during the second half of 2026. Initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027. Results from VIRAGE2 will inform the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial. For more details see About VIRAGE2 below.

In parallel with VIRAGE2, Theriva is engaging with the FDA to finalize the design of a potential Phase 2/3 study evaluating VCN-01 in children with retinoblastoma with vitreous seeds that are refractory/resistant to the use of current intravitreal chemotherapy. VCN-01 has received Rare Pediatric Disease designation for the treatment of retinoblastoma and may be eligible to receive a Priority Review Voucher if VCN-01 is approved in this indication by September 30, 2029.

About Pancreatic Ductal Adenocarcinoma

Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma (PDAC) accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.

About VCN-01

VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action is intended to enable VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in Company- and investigator-sponsored clinical trials in different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). VCN-01 has also been made available for compassionate use in retinoblastoma patients, and 2 patients have been treated in this program. VCN-01 has been granted Orphan Drug designation for the treatment of metastatic PDAC and retinoblastoma in Europe and the USA, as well as FDA Fast Track designation for the treatment of metastatic PDAC and Rare Pediatric Disease designation for the treatment of retinoblastoma. More information on VCN-01 clinical trials is available at Clinicaltrials.gov.

About VIRAGE

VIRAGE (EUCT 2024-511290-30-00; NCT05673811) was a two-arm, Phase 2b open-label, randomized, controlled, multicenter clinical trial in patients with histologically confirmed, newly-diagnosed metastatic PDAC. A total of 112 patients were enrolled at 5 sites in the U.S. and 9 sites in Spain. In both the control and VCN-01 (zabilugene almadenorepvec) treatment arms, patients received gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy in repeated 28-day cycles until disease progression. In the VCN-01 treatment arm only, patients were also administered intravenous VCN-01 seven-days prior to starting the first and fourth cycles of gemcitabine/nab-paclitaxel treatment (study days 1 and ~92 respectively). As previously reported and presented, PDAC patients in the VCN-01 plus gemcitabine/nab-paclitaxel SoC treatment arm demonstrated increased overall survival, progression free survival, and duration of response compared to patients in the control arm treated with gemcitabine/nab-paclitaxel SoC alone. Greater improvements in these parameters were observed in patients who received 2 doses of VCN-01 administered 3 months apart, and the pharmacokinetics of VCN-01 were not different between the 2 doses despite the presence of neutralizing antibodies.

About VIRAGE2

VIRAGE2 (EUCT: 2026-525566-21-00; NCT07701486) is a Phase 2a, single-arm, open-label, clinical trial in 6 evaluable patients with histologically confirmed, newly diagnosed metastatic PDAC enrolled at a single site in Spain. Patients are intended to receive at least three "macrocycles" of VCN-01 (zabilugene almadenorepvec) and gemcitabine/nab-paclitaxel SoC chemotherapy, followed by SoC gemcitabine/nab-paclitaxel cycles until disease progression. In each VCN-01 macrocycle, intravenous VCN-01 is administered on day 1 followed by gemcitabine/nab-paclitaxel SoC chemotherapy on days 8, 15, 22, 36, 43, and 50. Macrocycles are repeated on days 57 and 113. The primary objective of the VIRAGE2 trial is to evaluate whether administration of at least 3 doses of VCN-01, with 2 months between doses, is well tolerated by patients without adversely impacting VCN-01 pharmacodynamics. Primary endpoints for the trial are the adverse event profile and levels of VCN-01 viral genomes in blood. Secondary endpoints include objective response rate, duration of response, progression free survival, overall survival, and circulating levels of anti-VCN-01 neutralizing antibodies. Exploratory endpoints include estimates of potential VCN-01 shedding by measuring VCN-01 viral genomes in sputum and stool. The study is not formally powered for evaluation of clinical efficacy endpoints and is intended to support evaluation of the potential efficacy of the more frequent repeated dosing regimen in subsequent clinical trials.

(Press release, Theriva Biologics, SEP 30, 2026, View Source [SID1234671187])

On September 30, 2026 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company focused on infectious disease, reported the preliminary results of its tender offer (the "Offer") to purchase for cancellation up to US$230 million in value of its common shares (the "Shares"). The Offer proceeded by way of a modified Dutch auction, which had a tender price range from US$5.00 per Share to US$5.75 per Share, and included the option for shareholders to participate via a proportionate tender. The Offer expired at 5:00 p.m. (New York City time) on September 29, 2026. All amounts are in U.S. dollars.

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In accordance with the terms and conditions of the Offer and based on the preliminary calculation of TSX Trust Company, as depositary for the Offer (the "Depositary"), Arbutus expects to take up and pay for 46,000,000 Shares at a price of US$5.00 per Share under the Offer (the "Purchase Price"), representing an aggregate purchase price of US$230 million, excluding fees and expenses relating to the Offer, and approximately 23 percent of the total number of Arbutus’s issued and outstanding Shares as of the close of business on September 29, 2026. Immediately following completion of the Offer, Arbutus anticipates that approximately 153,275,907 Shares will be issued and outstanding.

Based on the preliminary calculation of the Depositary, 65,907,215 Shares were validly tendered and not properly withdrawn pursuant to auction tenders at or below the Purchase Price and pursuant to purchase price tenders. Since the Offer was oversubscribed, shareholders who made auction tenders at or below the Purchase Price and shareholders who made, or were deemed to have made, purchase price tenders will have the number of Shares purchased prorated following the determination of the final results of the Offer (other than "odd lot" tenders, which are not subject to proration). Arbutus currently expects that shareholders who made auction tenders at or below the Purchase Price and shareholders who made, or were deemed to have made, purchase price tenders will have approximately 55 percent of their tendered Shares purchased by Arbutus. Shareholders who made auction tenders at a price in excess of the Purchase Price should not expect to have any of those Shares purchased by Arbutus. 9,307,231 Shares are anticipated to be taken up and purchased pursuant to proportionate tenders, which are purchased in a separate pool and are not subject to proration.

Roivant Sciences Ltd., the beneficial owner of 38,847,462 Shares, approximately 19.5% of Arbutus’s issued and outstanding Shares as of September 29, 2026, made a proportionate tender under the Offer and will maintain its proportionate Share ownership at approximately 19.5% percent following completion of the Offer.

The number of Shares expected to be purchased, the estimated proration factor, the number of Shares expected to remain outstanding after completion of the Offer and the Purchase Price referred to above are preliminary, remain subject to verification by the Depositary, and are based on the assumption that all Shares tendered through notice of guaranteed delivery will be delivered within the one trading-day settlement period. Following take-up and payment for Shares purchased under the Offer, Arbutus will issue a press release announcing the final results, including the final proration factor and the final Purchase Price.

Promptly after such press release, payment for the Shares accepted for purchase will be made in accordance with the terms of the Offer and applicable law, and the Depositary will return all other Shares tendered and not purchased.

The full details of the Offer are described in the offer to purchase and issuer bid circular dated August 24, 2026, as well as the related letter of transmittal and notice of guaranteed delivery, copies of which were filed and are available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov.

This news release is for informational purposes only and does not constitute an offer to buy or the solicitation of an offer to sell Shares.

(Press release, Arbutus Biopharma, SEP 30, 2026, View Source [SID1234671186])

On September 30, 2026 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported that the European Patent Office ("EPO") has granted an important patent covering the composition of matter for NUC-7738.

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This patent (EP 3683225) is a key component of the patent protection for NUC-7738, which currently consists of over 85 issued patents worldwide. The composition-of-matter patent covers the chemical structure of NUC-7738, NuCana’s novel anti-cancer agent currently being evaluated in the Phase 2 part of a Phase 1/2 clinical study (NuTide:701) in combination with Keytruda (pembrolizumab) in patients with PD-1 inhibitor-resistant metastatic melanoma.

Securing this patent represents an important milestone for NuCana, further strengthening the Company’s long-term global intellectual property strategy and the potential commercial protection of NUC-7738.

Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer, said: "We are delighted that the EPO has granted this important new patent, which further strengthens the intellectual property protection of NUC-7738 and reflects the strength and novelty of our science. This composition-of-matter patent is a critical addition to our global patent estate for NUC-7738, which now spans over 85 issued patents worldwide, and builds upon similar composition-of-matter patents previously granted in both the United States and China. This underscores our commitment to protecting NUC-7738’s long-term commercial potential across all major markets. With cash resources expected to fund our planned operations into 2029, we believe we are well positioned to advance the clinical development of NUC-7738 and to deliver on a number of important milestones over the remainder of 2026 as we work to bring meaningful new treatment options to patients with cancer."

(Press release, Nucana, SEP 30, 2026, View Source [SID1234671183])