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Calidi Biotherapeutics Presents New Data on its Therapeutic Lead, CLD-401, at the 2025 SITC Annual Meeting and Holds Its First Investor Day at SITC

On November 10, 2025 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported new data on its first therapeutic candidate from its RedTail platform, CLD-401, at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

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CLD-401 is a tumor-tropic oncolytic virus designed to home to metastatic sites after systemic administration, replicate only in tumors cells, induce an immune priming event at the tumor site, and express high levels of IL-15 superagonist, a potent cytokine that induces NK and T-cell responses to the tumor, in the tumor microenvironment (TME).

"Our latest data demonstrate that in our syngeneic murine models, our RedTail platform is protected from immune clearance after systemic administration and can find and specifically replicate in tumor cells at metastatic sites," said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "The data also demonstrate that the platform can effectively express genetic medicines at the tumor site in concentrations that are similar to what is achievable with localized dosing while avoiding systemic exposure."

"In our syngeneic models, we are demonstrating levels of IL-15 superagonist in the tumor microenvironment after systemic administration that are comparable to levels seen with intrathecal administration of Anktiva in the bladder," added Eric Poma, PhD, Chief Executive Officer. "The level of IL-15 superagonist in serum or organs in these models is several orders of magnitude lower than what is expressed in the tumor. We believe this represents an unprecedented level of targeted genetic medicine delivery and expression."

Link to SITC (Free SITC Whitepaper) poster View Source

Calidi is currently conducting IND-enabling studies for CLD-401 and anticipates submitting an Investigational New Drug (IND) application by the end of 2026. The Company is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

In addition to the data presented, Calidi also held an investor day featuring members of its Scientific Advisory Board. Dr. Dimitri Zamarin, a world-renowned expert in virotherapy, from the Icahn School of Medicine at Mount Sinai and Dr John Wrangle, a thoracic medical oncologist with pioneering clinical work on IL-15 superagonist in patients, at the Medical University of South Carolina (MUSC). Both investigators spoke on the promise and differentiation of CLD-401 and the RedTail platform.

(Press release, Calidi Biotherapeutics, NOV 10, 2025, View Source [SID1234659707])

Avenzo Therapeutics Granted Fast Track Designation for AVZO-1418, a Potential Best-in-Class EGFR/HER3 Bispecific Antibody-Drug Conjugate, for the Treatment of Patients with EGFR-Mutated TKI-Pretreated NSCLC

On November 10, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AVZO-1418 (DB-1418), a potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate (BsADC).

The designation was granted for the treatment of patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation, whose disease has progressed on or after therapy with an EGFR tyrosine kinase inhibitor (TKI).

"We are excited to receive this Fast Track designation from the FDA, underscoring the promise of AVZO-1418, especially for patients with EGFR-Mutated TKI-Pretreated NSCLC," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "This designation has the potential to help expedite the development of AVZO-1418, which we continue to rapidly advance in Phase 1."

AVZO-1418 is currently being studied in a Phase 1/2 first-in-human, open-label clinical study designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors.

About Fast Track Designation
Fast Track is a FDA process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
Rolling Review of a Biologic License Application or New Drug Application by the FDA

(Press release, Avenzo Therapeutics, NOV 10, 2025, View Source [SID1234659706])

ArriVent BioPharma Reports Third Quarter 2025 Financial Results

On November 10, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the third quarter ended September 30, 2025, and highlighted recent Company progress.

"Our late-stage firmonertinib program continues to make strong progress across EGFR-mutant NSCLC populations, with two global Phase 3 pivotal studies being conducted in uncommon EGFR mutant non-small cell lung cancer (NSCLC). Backed by compelling data in both PACC and exon 20 insertion mutations, firmonertinib consistently shows the potential to address significant unmet needs in these underserved patient populations," said Bing Yao, CEO of ArriVent. "Following our strong Phase 1b findings, we are advancing to pivotal development with enrollment of the first patient in our global pivotal Phase 3 trial for PACC mutant NSCLC expected in the fourth quarter of this year. Additionally, we project topline pivotal data from our global Phase 3 trial in exon 20 insertion mutant NSCLC in early 2026, a patient population for which firmonertinib received FDA Breakthrough Therapy Designation."

Dr. Yao continued, "Our antibody-drug conjugate (ADC) portfolio is also advancing with our lead candidate ARR-217, a CDH17-targeted ADC with best-in-class potential for the treatment of gastrointestinal cancers, in an ongoing Phase 1 trial. We expect additional ADC programs to progress toward the clinic, expanding our ADC portfolio across multiple solid tumor indications. With a strong balance sheet and projected cash runway into mid-2027, we believe we are well-positioned to deliver on multiple near-term catalysts."

Third Quarter 2025 and Recent Highlights

Firmonertinib

● Final Phase 1b data in EGFR PACC mutant NSCLC. In September 2025, ArriVent presented final proof-of-concept data from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with NSCLC harboring EGFR PACC mutations at the 2025 World Conference on Lung Cancer (WCLC). Firmonertinib demonstrated clinically meaningful progression free survival, central nervous system (CNS) complete responses, and a manageable safety profile consistent with previous trials in what we believe to be the first clinical dataset testing an EGFR inhibitor in a prospectively defined population of EGFR PACC mutant NSCLC.

Pipeline

● Clinical advancement of ADC lead candidate ARR-217 (MRG007). Phase 1 dose escalation continues in the Phase 1 study for ARR-217, a CDH17-targeted ADC, in gastrointestinal malignancies with our partner, Lepu Biopharma Co., Ltd. In addition, ArriVent has received FDA IND clearance for ARR-217.
Upcoming Milestones

● First-line EGFR PACC registrational study. Enrollment of first patient in the randomized, global pivotal ALPACCA Phase 3 study for first-line firmonertinib monotherapy in EGFR PACC mutant NSCLC expected in Q4 2025.

● Firmonertinib Pivotal EGFR exon 20 insertion data. Top-line firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertion mutant NSCLC is projected to be in early 2026.
Corporate

● Appointed Brent S. Rice as Chief Commercial Officer. In September 2025, ArriVent appointed Brent S. Rice as Chief Commercial Officer who joins ArriVent with over 25 years of U.S. and global commercial experience in the biotechnology and pharmaceutical industry. Before joining ArriVent, Brent most recently served as the Senior Vice President and global Chief Commercial Officer, and Managing Director U.S. at Autolus Therapeutics Ltd. where he led global commercialization, commercial strategy and business portfolio management of their early and late-stage pipeline, including next generation oncology therapies.
2025 Financial Results

● As of September 30, 2025, the Company had cash and investments of $305.4 million which is expected to fund operations to mid-2027.

● Net cash used in operations was $129.9 million and $54.1 million for the nine months ended September 30, 2025 and 2024, respectively.

● Research and development expenses were $121.2 million and $58.8 million for the nine months ended September 30, 2025 and 2024, respectively. This includes a $40 million one-time upfront payment for the in-licensing of ARR-217 from Lepu Biopharma.

● General and administrative expenses were $17.5 million and $11.8 million for the nine months ended September 30, 2025 and 2024, respectively.

● Net loss was $130.8 million and $59.9 million for the nine months ended September 30, 2025 and 2024, respectively.

(Press release, ArriVent Biopharma, NOV 10, 2025, View Source [SID1234659705])

Alpha-9 Oncology Appoints Paul Blanchfield as Chief Executive Officer

On November 10, 2025 Alpha-9 Oncology ("Alpha-9" or "the Company"), a clinical-stage radiopharmaceutical company developing targeted cancer therapies, reported the appointment of Paul Blanchfield as Chief Executive Officer and a member of the Board of Directors. Mr. Blanchfield brings more than 15 years of diverse leadership experience across radiopharmaceuticals, biotechnology, and healthcare – most recently as President of Lantheus, where he oversaw Commercial, R&D, Medical, and Technical Operations.

"Paul brings exceptional operational experience and deep industry expertise in radiopharma – making him an ideal fit to lead our team at this pivotal moment," said Patrick Heron, Chairman of the Board, Alpha-9 Oncology. "His experience in building and leading commercial and scientific organizations positions him to guide Alpha-9 through its next phase of growth as we advance our clinical programs."

Alpha-9 Oncology is focused on differentiated, highly targeted radiopharmaceuticals that deliver radiation directly to tumor cells while limiting exposure to healthy tissue. The company has developed best-in-class molecules against a range of targets and is currently progressing several drug candidates through early clinical studies.

"Alpha-9 is at the forefront of radiopharmaceutical innovation," said Paul Blanchfield, Chief Executive Officer, Alpha-9 Oncology. "I am honored to join this talented team at such an exciting time for the company, as we accelerate a pipeline of first and best-in-class clinical-stage assets with the potential to meaningfully improve the treatment of people living with cancer."

Mr. Blanchfield joins Alpha-9 during a period of strong momentum following the company’s $175 million Series C financing led by Lightspeed Venture Partners and Ascenta Capital in Q4 2024.

Prior to his time at Lantheus, Mr. Blanchfield held senior roles at Takeda and Shire Pharmaceuticals, including Head of U.S. Immunology, General Manager for Nordics-Baltics, Head of Corporate Strategy, and Chief of Staff to the CEO.

He holds an MBA and MA in Education from Stanford University, and a BA in Economics from Duke University.

(Press release, Alpha9 Oncology, NOV 10, 2025, View Source [SID1234659704])

Allogene Therapeutics Announces Participation in Upcoming Investor Conferences

On November 10, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it will participate in three upcoming investor conference in November and December.

TD Cowen’s Immunology & Inflammation Virtual Summit
Wednesday, November 12
1:30PM PT/4:30PM ET

Jefferies Global Healthcare Conference in London
Tuesday, November 18
2:00AM PT/5:00AM ET/10:00AM GMT

Piper Sandler 37th Annual Healthcare Conference
Tuesday, December 2
9:00AM PT/12:00PM ET

Any available webcasts will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, NOV 10, 2025, View Source [SID1234659703])