On October 31, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported its Quarterly Cash Flow report (Appendix 4C) for the quarter ended 30 September 2025.

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CLINICAL UPDATES

Azer-cel Phase 1b clinical trial records overall response rate of 81% in relapsed/refractory DLBCL

Late in the quarter, the Company reported an overall response rate (ORR) of 81% in its ongoing Phase 1b clinical trial of azer-cel (azercabtagene zapreleucel), an allogeneic, offthe-shelf CD19 CAR T-cell therapy being developed for patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Of the sixteen patients treated so far, thirteen have responded to therapy, including seven complete responses (CRs) and six partial responses (PRs). This marks an increase from the previously reported 79% ORR in August 2025, following two new patients achieving partial responses and one transitioning from partial to complete response at the Day 90 scan. Importantly, responses have been both rapid and durable, with the average time to best response occurring within one to three months, and ongoing durability data continuing to strengthen.

The first patient dosed with azer-cel and IL-2 in 2024 remains cancer-free for more than eighteen months, while additional responders are maintaining outcomes beyond five, five, six, and fifteen months, highlighting the long-lasting clinical activity of azer-cel. Patients enrolled in this trial represent a heavily pre-treated population, having typically failed at least three prior lines of therapy, and in many cases up to four to six, including autologous CAR T-cell treatments. These results reinforce the potential of azer-cel to provide a new therapeutic option for patients who have exhausted existing avenues.

Two patients who achieved a complete (CR) or partial response (PR) following azer-cel treatment became eligible for allogeneic stem cell transplant (allo-SCT). This approach using azer-cel as a bridge to allo-SCT has the potential to consolidate response and deliver long-term disease control. The sequence of azer-cel followed by allo-SCT may yield durable remission rates that exceed those typically observed with conventional salvage regimens.

Azer-cel is being administered in combination with interleukin-2 (IL-2), a cytokine known to enhance the survival and cancer-killing function of CAR T-cells, with the combination appearing to be contributing to both the depth and durability of responses.

Azer-cel aims to address key limitations of autologous CAR T therapies, including long manufacturing times, logistical constraints, and limited accessibility to treatment centres, by offering a readily available, on-demand cell therapy manufactured from healthy donor T-cells. Imugene continues to enrol patients at ten US and five Australian sites.

During the period the study also expanded to include and treat CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including primary central nervous system lymphoma (PCNSL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), follicular lymphoma (FL) and leukemias such as chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL).

Following quarter end, the company also provided a positive update to the market on the CAR T naïve patient expansion:
• 83% Overall Response Rate (ORR) in six evaluable heavily pretreated, CAR T naïve patients (no prior CAR T treatment). 5/6 responders, with results from the sixth patient pending
• 50% Complete Response (CR) rate, 3/6 patients
• Ten patients treated to date across multiple CD19+ B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM) and primary CNS lymphoma (PCNSL)
• Enrolment progressing significantly faster than the CAR T-relapsed DLBCL cohort, supporting a potential expedited clinical path

Following an internal portfolio review, Imugene is refining its investment focus toward programs with near-term clinical and commercial milestones.

In light of the recent encouraging azer-cel results and broader capital considerations, the Company is exploring alternative development pathways for the CF33 programs, including potential collaborations with external partners who are encouraged by its potential.

As part of this approach, Imugene will moderate internal funding for CF33 and onCARlytics, while assessing partnership, out-licensing, or joint venture opportunities to support continued advancement of these programs.

FINANCIAL

$24.9 million institutional Placement and Share Purchase Plan

During the quarter, the Company successfully completed a $22.5 million institutional Placement and a $2.42 million Share Purchase Plan (SPP) for eligible shareholders, both priced at $0.33 per share. The Placement was strongly supported by new Australian and international institutional and sophisticated investors.

Participants in both the Placement and SPP received three free, attaching listed options for every four new shares subscribed, exercisable at $0.43 by 30 March 2026. Upon exercising these options, investors will receive one additional "piggyback" option per option exercised, with an exercise price of $0.86 and expiry on 30 June 2028.

Proceeds from the capital raising will primarily fund Imugene’s azer-cel (azercabtagene zapreleucel) program through initiation of a pivotal clinical trial in calendar year 2026, while also extending the company’s funding runway into mid-2027 and supporting general working capital needs.

(Press release, Imugene, OCT 31, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/7ce28d9c-c2ac-c33f-0f13-955286db572b/03017251.pdf [SID1234657171])

On October 30, 2025 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported it will present new preclinical and translational data from multiple investigational programs at two scientific conferences in November – the World ADC Conference in San Diego, California, and PEGS Europe, in Lisbon, Portugal.

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At these global forums, SOTIO will highlight progress across its next-generation antibody-drug conjugates (ADCs) and immunocytokine pipeline, which is advancing toward new treatment options for patients with solid tumors in areas of unmet medical need. Topics of the presentations include:

SOT106, a novel ADC targeting LRRC15 for the treatment of mesenchymal tumors, with a particular focus on soft tissue sarcoma and osteosarcoma. Preclinical data demonstrate a high therapeutic index and strong anti-tumor activity, supporting its potential best-in-class profile.
SOT109, SOTIO’s lead CDH17-targeting ADC for gastrointestinal cancers, including colorectal and other GI malignancies. Preclinical findings show robust efficacy and a favorable safety profile, reinforcing best-in-class therapeutic potential.
SOT201, a cis-acting PD-1/IL-15 mutein-based immunocytokine designed to target and reinvigorate exhausted T cells in the tumor microenvironment while maintaining a systemic immune balance. SOT201 is currently under clinical evaluation in the Phase 1 VICTORIA-01 study in patients with advanced metastatic cancers.
"These data reflect the significant progress we are making across our pipeline and the strength of our scientific foundation," said Radek Špíšek, M.D., Ph.D., chief executive officer of SOTIO. "By integrating deep insights into cancer biology with next-generation therapeutic modalities, we aim to provide new therapies for diseases with high unmet medical need."

World ADC oral presentation details:

Title: "Exploring Novel Pharmacology & Translational Aspects of SOT106 Targeting LRRC15 in Solid Tumors"
Session: Pharmacology track
Presenter: Lenka Palova Jelinkova
Date & Time: November 3, 2025, 10:30am PT

Title: "Advancing a Preclinical Pipeline of ADCs Targeting Gastrointestinal Cancers"
Session: Preclinical track
Presenter: Amy Jensen-Smith
Date & Time: November 5, 2025, 3:00pm PT

PEGS Europe oral presentation details:

Keynote Presentation Title: "SOT109: A CDH17 Targeting ADC with Best-in-Class Potential Activity for the Treatment of CRC and Other GI Cancers"
Session: Engineering Antibody-Drug Conjugates
Presenter: Radek Špíšek
Date & Time: November 12, 2025, 1:50pm CET

Title: "Preclinical Pharmacology and Translational Aspects of a Cis-Acting PD-1/IL-15 Mutein-Based Immunocytokine SOT201"
Session: Next-Generation Immunotherapies
Presenter: Anna Jirovec
Date & Time: November 13, 2025, 5:10pm CET

Presentation materials will be available upon request following the live presentations.

(Press release, SOTIO, OCT 30, 2025, View Source [SID1234657189])

On October 30, 2025 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that the first patient has been treated in a Phase 2 clinical trial investigating FL115 in combination with Bacillus Calmette-Guérin (BCG). The study will assess the anti-tumor effect of the combination therapy, including Complete Response Rate and Duration for carcinoma in situ (CIS) NMIBC patients, and Disease Free Survival and Relapse Free Survival for papillary (Ta/T1) NMIBC patients.

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FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. The start of the Phase 2 clinical trial builds on positive data from the Phase 1 trial where FL115 demonstrated favorable safety and efficacy in the same patient population. As a monotherapy at the recommended dose for expansion, 4/6 patients achieved responses longer than 3 months, of which 2 patients achieving responses longer than 9 months. This dose of FL115 in combination with BCG will be investigated in the Phase 2 trial.

"Dosing the first patient in our Phase 2 trial for FL115 marks a defining moment for Forlong, as we advance our lead candidate further into clinical development and continue to validate the potential of our synthetic immunology platforms," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "FL115 stands out with favorable safety and preliminary efficacy observed in multiple Phase 1 clinical studies in advanced solid tumors and NMIBC. With FL115 interim data for advanced solid tumor to be presented as Late Breaking Abstract on Nov 8 at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2025), this trial gives us the opportunity to further validate FL115 as potential Best-in-class IL-15 superagonist, and bring new treatment options for cancer patients in need."

The Phase 2 clinical trial plans to enroll three arms: BCG unresponsive CIS NMIBC patients, BCG unresponsive high risk papillary NMIBC patients, and BCG naïve medium/high risk NMIBC patients. The trial will be conducted at over 15 investigator sites in China.

About FL-115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, OCT 30, 2025, View Source [SID1234657188])

On October 30, 2025 Synthekine Inc., an engineered cytokine therapeutics company, reported that data from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, will be presented in a late-breaking oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025 taking place in National Harbor, MD., from November 7-9, 2025. In this study, STK-012 is being evaluated in combination with standard-of-care pembrolizumab + chemotherapy in first-line, PD-L1 negative nonsquamous non-small cell lung cancer (NSCLC) patients. The company will also present new preclinical data on combinations of STK-012 and T cell engagers.

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"We are excited to present our first clinical data in first-line, PD-L1 negative nonsquamous NSCLC patients from the ongoing trial of STK-012, our lead program and a novel approach to biasing IL-2," said Debanjan Ray, chief executive officer of Synthekine. "PD-L1 negative patients comprise approximately one-third of the nonsquamous NSCLC population, and these patients receive significantly reduced benefit from standard-of-care chemoimmunotherapy versus PD-L1 positive patients. We look forward to sharing these results with the scientific community, and the further development of STK-012 in this setting in our SYNERGY-101 study, a global, randomized Phase 2 trial which is currently ongoing."

Details are as follows and available on the SITC (Free SITC Whitepaper) online itinerary:
(Please note that the late-breaking clinical data will be shared both as an oral presentation and a poster.)

Title: Initial Phase 1a/1b Results of STK-012, an α/β IL-2 Receptor Biased Partial Agonist, with Pembrolizumab, Pemetrexed, and Carboplatin in 1L PD-L1 Negative Non-Squamous NSCLC
Session Title: Clinical Oral Abstract Session 2
Session Date & Time: Saturday, November 8, 2025, 2:00 PM ET
Location: Gaylord National Resort and Convention Center, Potomac Ballroom
Abstract Number: 1345

Title: Initial Phase 1a/1b Results of STK-012, an α/β IL-2 Receptor Biased Partial Agonist, with Pembrolizumab, Pemetrexed, and Carboplatin in 1L PD-L1 Negative Non-Squamous NSCLC
Session Title: Exhibits and Poster Reception
Session Date & Time: Friday, November 7, 2025, 5:35 PM – 7:00 PM ET
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
Poster Board Number: 1345
Abstract Number: 1345

Title: STK-012, a First-in-Class α/β IL-2 Receptor Biased Partial Agonist Enhances the Anti-Tumor Efficacy of Bispecific Antibodies
Session Title: Exhibits and Poster Reception
Session Date & Time: Saturday, November 8, 2025, 5:10 PM – 6:35 PM ET
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
Poster Board Number: 682
Abstract Number: 682

Copies of the presentation and posters will be available on Synthekine’s website following presentation at the meeting.

(Press release, Synthekine, OCT 30, 2025, View Source [SID1234657187])

On October 30, 2025 Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, inflammatory and autoimmune diseases, reported the pricing of an underwritten public offering of 13,700,000 shares of its common stock at a price to the public of $18.25 per share. Gross proceeds to Arcus Biosciences from the offering are expected to be $250 million, before deducting underwriting discounts and commissions and offering expenses. All of the shares of common stock are being offered by Arcus Biosciences. In addition, Arcus Biosciences has granted the underwriters a 30-day option to purchase up to 2,055,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on November 3, 2025, subject to customary closing conditions.

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Leerink Partners, Goldman Sachs & Co. LLC, Cantor, Mizuho and Truist Securities are acting as joint bookrunning managers for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission (SEC) on February 28, 2023, and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at (866) 471-2526, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by emailing [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Arcus Biosciences, OCT 30, 2025, View Source [SID1234657186])