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A2 Bio to Present Early Safety and Efficacy Data from EVEREST-2 Study during 2025 Annual Meeting of the Society for Immunotherapy of Cancer

On October 3, 2025 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies to selectively target tumor cells and protect normal cells, reported the acceptance of four abstracts for presentation during the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) taking place November 5-9, 2025, in National Harbor, Md (Press release, A2 Biotherapeutics, OCT 3, 2025, View Source [SID1234656430]).

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A2 Bio will present posters detailing early safety and efficacy from the ongoing phase 1/2 EVEREST-2 study and an enrollment update for the ongoing DENALI-1 study. Additional posters will present approaches to boost potency and preserve selectivity of Tmod-based precision cell therapies. The accepted abstracts are available online on the SITC (Free SITC Whitepaper) website.

Poster Presentation Details

Abstract Title

Presenting Author

Abstract Number

Poster Presentation Date

Location

EVEREST-2: a phase 1/2 study of A2B694, a logic‑gated Tmod CAR T therapy to treat solid tumors expressing mesothelin (MSLN) with HLA-A*02 loss of heterozygosity: initial safety and efficacy results

Jeffrey Ward, M.D., Ph.D.

Washington University

535

Friday, Nov. 7

10 am – 7pm ET

Prince George ABC Halls,

Lower-Level Atrium,

Gaylord National Resort and Convention Center

DENALI-1: a seamless phase 1/2 study of A2B395, a logic gated, allogeneic, Tmod CAR T therapy, in patients with EGFR expressing solid tumors with human leukocyte antigen A*02 loss of heterozygosity

Salman Punekar, M.D.

New York University Langone Health, Perlmutter Cancer Center

585

Genetic screens to identify novel functional modules for a NOT gate

Chawita "Jelly" Netirojjanakul, M.Phil., Ph.D.

A2 Biotherapeutics, Inc.

259

An inducible signal 1 mimic overcomes limited access to antigen for solid tumor cell therapy

Charlie Kirsh, B.S.

A2 Biotherapeutics, Inc.

239

About EVEREST-2

EVEREST-2 (NCT06051695) is a seamless Phase 1/2, open-label, nonrandomized study evaluating the safety and efficacy of A2B694, an autologous logic-gated investigational cell therapy developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets mesothelin and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. The study is recruiting patients with non-small cell lung cancer, pancreatic cancer, ovarian cancer, colorectal cancer, mesothelioma, and other solid tumors that express mesothelin and have lost HLA-A*02 expression. Patients are enrolled through BASECAMP-1 (NCT04981119), a master prescreening study that identifies patients with HLA LOH at any time in the course of their disease via next-generation sequencing. Upon disease progression the participant may screen for enrollment in EVEREST-2.

About DENALI-1

DENALI-1 (NCT06682793) is a seamless Phase 1/2, open-label, nonrandomized study evaluating the safety and efficacy of A2B395, an allogeneic logic-gated Tmod CAR T-cell product in adults with solid tumors that express EGFR and have lost HLA-A*02 expression, including non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, renal cell carcinoma, colorectal cancer, and other solid tumors. Patients are enrolled through BASECAMP-1 (NCT04981119), a master prescreening study that identifies patients with HLA LOH at any time in the course of their disease via next-generation sequencing. Upon disease progression the participant may screen for enrollment in DENALI-1.

About BASECAMP-1

BASECAMP-1 (NCT04981119) is a prescreening study to identify patients for potential treatment in A2 Bio clinical trials. It is a novel approach to help optimize patient treatment outcomes by enabling patients’ immune cells to be banked in their healthiest state earlier in their course of cancer treatment. Next-generation sequencing is used to identify patients who have lost HLA-A*02, the biomarker of interest for the A2 Bio studies. Patients eligible for autologous therapy undergo leukapheresis to collect, process, and store patient T cells for future Tmod CAR T cell therapy. BASECAMP-1 is currently enrolling patients with non-small cell lung cancer, pancreatic cancer, ovarian cancer, colorectal cancer, mesothelioma, head and neck squamous cell carcinoma, triple-negative breast cancer, renal cell carcinoma, and other solid tumors.

About the Tmod Platform

A2 Bio has pioneered a precision-targeting cellular system – the Tmod platform – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized, and effective T-cell targeting. The blocker component equips Tmod cells with the capacity to identify tumors as distinct from normal cells.

Dispatch Bio Announces Upcoming Presentations at Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting

On October 3, 2025 Dispatch Bio, a biotech company engineering a universal treatment across solid tumors, leveraging its first-in-class Flare platform, reported two upcoming presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting, taking place in National Harbor, Md., Nov. 5-9, 2025 (Press release, Dispatch Bio, OCT 3, 2025, View Source [SID1234656429]).

Presentation details are as follows:

Title: DISP-10 is a novel CAR T and tumor-specific virus combination undergoing clinical development that is designed for use as a universal treatment for epithelial tumors
Abstract: 393
Primary Category: Cellular Therapies
Poster Presentation Day: Friday, Nov. 7
Presenter: Lisa Cucolo, Ph.D., Senior Scientist at Dispatch

Title: Combination of a tumor-specific virus and CAR T to specifically and universally target tumors of epithelial origin and overcome challenges of the tumor microenvironment
Abstract: 394
Primary Category: Cellular Therapies
Poster Presentation Day: Saturday, Nov. 8
Presenter: Raymond Liu, Ph.D., Co-Founder and Head of Synthetic Biology at Dispatch

HanchorBio Announces Acceptance of HCB301 Abstract for Poster Presentation at SITC 2025 Annual Meeting

On October 3, 2025 HanchorBio, a clinical-stage biotechnology company focusing on immune-oncology and dedicated to developing next-generation multi-specific immunotherapies, reported that an abstract detailing preclinical data on HCB301, the company’s novel tri-specific anti-cancer fusion protein, has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting (Press release, Hanchor Bio, OCT 3, 2025, View Source [SID1234656428]). The meeting will take place from November 5 to 9, 2025, in National Harbor, Maryland.

Acceptance for a poster presentation at the SITC (Free SITC Whitepaper) Annual Meeting underscores the scientific rigor and innovation behind HCB301’s development. SITC (Free SITC Whitepaper) is the world’s largest annual conference solely dedicated to cancer immunotherapy. Each year, more than 1,300 abstracts are submitted, evaluated according to rigorous selection criteria based on research quality, novelty, and their potential to advance cancer immunotherapy.

Presentation Details

The accepted abstract, titled "A Novel Tri-Specific Fc Fusion Protein Targeting PD-L1, CD47, and TGFβ Remodels the Tumor Microenvironment and Enhance Anti-Tumor Immunity", will be presented on Saturday, November 8, 2025. The presentation will highlight preclinical efficacy and safety data supporting HCB301’s potential as a first-in-class immune-enhancing biologic that targets key mechanisms of tumor immune evasion.

"We are honored to present these compelling preclinical data at SITC (Free SITC Whitepaper) 2025," said Wenwu Zhai, Chief Scientific Officer of HanchorBio. "HCB301 exemplifies the power of our FBDB platform to rationally design multi-specific biologics that restore immune activity and deliver enhanced anti-tumor responses."

About HCB301

HCB301 is a tri-functional IgG4 Fc fusion protein that incorporates:

An anti-PD-L1 antibody,
A high-affinity SIRPα variant to disrupt CD47-mediated "don’t eat me" signaling, and
A TGF-βRII trap domain.
Following successful preclinical development, HCB301 is now in a Phase 1 multi-regional clinical trial in the U.S. and Taiwan to evaluate its safety, tolerability, and anti-tumor activity in patients with advanced solid tumours.

In preclinical studies, HCB301 demonstrated:

Potent blockade of PD-L1 and TGF-β signaling,
Robust phagocytosis of CD47+ tumor cells in vitro with minimal red blood cell binding, suggesting an improved hematologic safety profile compared to CD47-targeting analogs, and
In vivo efficacy comparable to a triple-agent cocktail across multiple xenograft models.
The abstract will also be published in the Journal for ImmunoTherapy of Cancer (JITC) in February 2026 as part of the SITC (Free SITC Whitepaper) 2025 Final Supplement.

IceCure Medical’s ProSense® Cryoablation Granted FDA Marketing Authorization for Treatment of Low-Risk Breast Cancer in Women Aged 70 and Above: Significant Development in Giving Women with Breast Cancer Minimally Invasive Care

On October 3, 2025 Icecure Medical reported that the U.S. Food and Drug Administration ("FDA") has granted marketing authorization for ProSense, a minimally invasive cryoablation treatment for patients with early-stage low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over, an estimated population of 46,000 women annually in the U.S (Press release, IceCure Medical, OCT 3, 2025, View Source [SID1234656426]). The announcement was made on October 3, 2025, by IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), the developer of minimally invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal.

"We are excited to add a minimally invasive choice around breast cancer treatments and to offer patients an effective, outpatient procedure," said Eyal Shamir, Chief Executive Officer, IceCure. "With the ProSense Cryoablation System, we are giving women with low-risk, early-stage breast cancer the choice to freeze their cancer, not their lives, through an effective treatment that minimizes recovery time, and minimal cosmetic changes to the breast."

ProSense is the first and only medical device to be granted FDA marketing authorization for the local treatment of breast cancer.

ProSense is authorized by the FDA for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy. Biologically low-risk breast cancer is defined as unifocal tumor, size ≤1.5cm, ER+, PR+, HER2-, Ki-67<15% and/or genomic testing indicative of low-risk breast cancer, infiltrating ductal carcinoma (excluding lobular carcinoma, extensive intraductal component, or evidence of lymphovascular invasion), and clinically negative lymph node (N0). The authorized indication includes patients that are not suitable for surgery for breast cancer treatment. For a complete discussion of the benefits and risks of ProSense Cryoablation System for the local treatment of breast cancer, please visit our website.

In granting marketing authorization, the FDA requested that IceCure conduct a post-market surveillance study with the aim of producing additional data in this indication. The post-market study is expected to include approximately 400 patients at 30 sites.

Breast cancer cryoablation with ProSense, is a simple, quick, out-patient procedure that can have a notably positive impact on the patient experience and can be beneficial for patients seeking more choices.

"You don’t need any kind of cosmetic follow-up, you don’t have a scar, and you don’t have the feeling of having lost part of your breast, because it’s all still there," said breast cancer patient and ICE3 trial participant, Pam Dixon, when describing her experience with the ProSense cryoablation procedure. "There was no pain. It was one of the easiest things I’ve ever done. I don’t remember any limitations on my activity."

During the ProSense cryoablation procedure, a doctor injects local anesthesia and uses ultrasound imaging to guide a small cryoprobe, a thin hollow needle, into the breast tumor. Once the cryoprobe is placed, liquid nitrogen creates extremely cold temperatures (-170C°) which destroys the breast tumor by creating an ice ball around the targeted tissue. Key advantages of ProSense cryoablation procedure include:

Maintain breast shape: No tissue is removed and there is minimal scarring from the insertion of the cryoprobe. No breast reconstruction is needed.

Short, out-patient procedure with local anesthesia: Average cryoablation procedure time is approximately 30 – 45 minutes with no hospital waiting or overnight stay. Numbing agents (local anesthesia) are injected only into the area being treated and the ice formed during the procedure has a numbing effect.

Reduced recovery time: Patients typically return to normal activity within 24-hours. Median recovery time is one day with a range of 0 – 8 days.

The procedure is monitored in real-time by ultrasound to ensure the ice ball is growing sufficiently around the tumor, and to avoid damage to the skin or muscle. The doctor may use hydro-dissection to protect the skin or muscle during a procedure depending on the location of the tumor. The tissue destroyed by the ice ball is naturally reabsorbed by the body over time and adjacent tissue is left unharmed.

The FDA’s marketing authorization was based on an abundance of data including IceCure’s ICE3 trial which was published in the Annals of Surgical Oncology. With 194 patients, ICE3 is the largest multi-center clinical trial ever completed for liquid-nitrogen (LN2) based cryoablation for patients aged ≥60 with low-risk, early-stage breast cancer without surgically removing the breast tumor. Only 3.1% of patients with hormone receptor-positive and HER2-breast cancer treated locally with cryoablation and endocrine therapy (also known as hormone or hormonal therapy), experienced local recurrence of breast cancer within 5 years after treatment, based on the study results.

The majority of the cryoablation procedure-related adverse events besides breast cancer recurrence were edema (swelling), bruising, hematoma (bleeding into tissues), skin burn, and postoperative pain. These were mild in severity and all of these events resolved without any permanent effect.

ICE3 study lead author, Richard Fine, MD, FACS, of the West Cancer Center & Research Institute in Germantown, TN and past President of the American Society of Breast Surgeons emphasizes that, "The ICE3 study has proven that cryoablation with ProSense is a safe, minimally invasive ablative procedure with results similar to that of lumpectomy patients who took endocrine therapy, and has the benefit of being an office-based, non-surgical treatment. Further data coming out of the post-market study should continue to support that cryoablation with ProSense is a successful option in the de-escalation of breast cancer care in appropriately selected patients."

Conference webcast info:

Monday, October 6, 2025 at 8:30 AM
A live webcast will be available at: View Source
A recording of the webcast will be available at: ir.icecure-medical.com

About ProSense
The ProSense Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of early-stage, low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on our website.

ProSense is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.

ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens that door to fast and convenient office-based procedures for breast tumors.

Entry Into a Material Definitive Agreement

On October 3, 2025, XOMA Royalty Corporation (the "Company") reported to have entered into an "at the market" sales agreement (the "Common Stock Sales Agreement") with Leerink Partners LLC ("Leerink"), pursuant to which the Company may offer and sell from time to time up to $75,000,000 of shares of the Company’s common stock, par value $0.0075 (the "Common Shares"), through Leerink, as the Company’s sales agent (Filing, Xoma, OCT 3, 2025, View Source [SID1234656425]).

Sales of the Common Shares, if any, pursuant to the Common Stock Sales Agreement, may be made in transactions that are deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on or through The Nasdaq Global Market ("Nasdaq") or on any other existing trading market for the Common Shares. The Company has no obligation to sell any of the Common Shares under the Common Stock Sales Agreement, and may at any time suspend offers under the Common Stock Sales Agreement or terminate the Common Stock Sales Agreement.

Leerink will act as a sales agent and will use commercially reasonable efforts to sell on the Company’s behalf all of the Common Shares requested to be sold by the Company, consistent with their normal trading and sales practices, on mutually agreed terms between Leerink and the Company. The Company currently intends to use the net proceeds of the offering of Common Shares, if any, to acquire additional potential royalty and milestone revenue streams, for working capital and other general corporate purposes.

Under the terms of Common Stock Sales Agreement, the Company will pay Leerink a commission of up to 3.0% of the aggregate gross proceeds from each Common Share sold through it under the Common Stock Sales Agreement. In addition, the Company has also provided Leerink with customary representations, warranties and indemnification rights and has agreed to reimburse certain expenses incurred by Leerink in connection with the offering of Common Shares. The Common Stock Sales Agreement may be terminated by Leerink or the Company at any time upon notice to the other party, as set forth in the Common Stock Sales Agreement, or by Leerink at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that may materially impair Leerink’s ability to sell the Common Shares.

Preferred Stock Sales Agreement

Also on October 3, 2025, the Company entered into an "at the market" sales agreement (the "Preferred Stock Sales Agreement" and together with the Common Stock Sales Agreement, the "Sales Agreements") with H.C. Wainwright & Co., LLC ("Wainwright"), pursuant to which the Company may offer and sell from time to time up to $50,000,000 of the Company’s depositary shares (the "Depositary Shares," and together with the Common Shares, the "Shares"), each representing 1/1000th of a share of the Company’s 8.375% Series B cumulative perpetual preferred stock, par value $0.05, through Wainwright, as the Company’s sales agent.

Sales of the Depositary Shares, if any, pursuant to the Preferred Stock Sales Agreement, may be made in transactions that are deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act, including sales made directly on or through Nasdaq or on any other existing trading market for the Depositary Shares. The Company has no obligation to sell any of the Depositary Shares under the Preferred Stock Sales Agreement, and may at any time suspend offers under the Preferred Stock Sales Agreement or terminate the Preferred Stock Sales Agreement.

Wainwright will act as a sales agent and will use commercially reasonable efforts to sell on the Company’s behalf all of the Depositary Shares requested to be sold by the Company, consistent with their normal trading and sales practices, on mutually agreed terms between Wainwright and the Company. The Company currently intends to use the net proceeds of the offering of Depositary Shares, if any, to fund future dividends and any remaining net proceeds to acquire additional potential royalty and milestone revenue streams, for working capital and other general corporate purposes.

Under the terms of the Preferred Stock Sales Agreement, the Company will pay Wainwright a commission of up to 3.0% of the aggregate gross proceeds from each Depositary Share sold through it under the Preferred Stock Sales Agreement. In addition, the Company has also provided Wainwright with customary representations, warranties and indemnification rights and has agreed to reimburse certain expenses incurred by Wainwright in

connection with the offering of Depositary Shares. The Preferred Stock Sales Agreement may be terminated by Wainwright or the Company at any time upon notice to the other party, as set forth in the Preferred Stock Sales Agreement, or by Wainwright at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that may materially impair Wainwright’s ability to sell the Depositary Shares.

The offering and sale of the Shares has been registered under the Securities Act, pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-277794) (the "Registration Statement"), which was originally filed with the Securities and Exchange Commission ("SEC") on March 8, 2024 and declared effective by the SEC on June 17, 2024, the base prospectus contained within the Registration Statement, and prospectus supplements that were filed with the SEC on October 3, 2025 in connection with the offer and sale of the Shares under each applicable Sales Agreement. Brownstein Hyatt Farber Schreck, LLP, Nevada counsel to the Company, has issued a legal opinion regarding the validity of the Company’s securities that may be sold pursuant to the Registration Statement. A copy of the legal opinion is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Brownstein Hyatt Farber Schreck, LLP has issued legal opinions regarding the validity of the Common Shares that may be sold pursuant to the Common Stock Sales Agreement and the shares of the Company’s 8.375% Series B cumulative perpetual preferred stock underlying the Depositary Shares that may be sold pursuant to the Preferred Stock Sales Agreement. Copies of the legal opinions are filed as Exhibit 5.2 and 5.3 to this Current Report on Form 8-K, respectively. Gibson, Dunn & Crutcher LLP has issued a legal opinion regarding the validity of the Depositary Shares that may be sold pursuant to the Preferred Stock Sales Agreement. A copy of the legal opinion is filed as Exhibit 5.4 to this Current Report on Form 8-K.

The foregoing descriptions of the Sales Agreements do not purport to be complete and are qualified in their entirety by reference to the Sales Agreements, copies of which are filed as Exhibit 1.1 and 1.2 to this Current Report on Form 8-K and incorporated by reference herein.