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.

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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])

On November 10, 2025 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported that it intends to offer and sell shares of its common stock in an underwritten public offering. All of the shares of common stock in the proposed offering will be sold by INOVIO. INOVIO intends to grant the underwriter a 30-day option to purchase additional shares of its common stock in an amount up to 15% of the shares of common stock offered in the public offering under the same terms and conditions. The proposed offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Piper Sandler & Co. is acting as sole book-running manager for the offering.

A shelf registration statement relating to the shares of common stock offered in the offering described above was filed with the Securities and Exchange Commission ("SEC") on November 9, 2023 and declared effective by the SEC on January 31, 2024. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting: Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401; or by telephone at (800) 747-3924; or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered 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, Inovio, NOV 10, 2025, View Source [SID1234659719])

On November 10, 2025 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, reported its financial results for fiscal second quarter ended September 30, 2025, and provided a corporate update.

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"Over the past year, we have made steady progress deploying LungFit PH to hospitals across the U.S. and establishing a global distribution network. As the first and only FDA-approved tankless nitric oxide generator and delivery system that uses ambient air to produce nitric oxide on demand for hospital use, LungFit PH is delivering meaningful workflow and efficiency benefits for clinicians and hospital administrators. With the recent capital infusion, we plan to accelerate commercial execution and advance regulatory initiatives, including select international submissions and our second-generation LungFit PH. We also welcome Beyond Air Board member Bob Goodman as Interim Chief Commercial Officer to lead our commercial strategy and team transitioning from David Webster, who leaves us with our gratitude. Bob brings decades of commercial leadership across medtech and pharma, including senior roles at BioTelemetry and Philips Healthcare, and will oversee U.S. and international commercial strategy, team expansion, and channel optimization," said Steve Lisi, Chairman and Chief Executive Officer.

We are gearing up for regulatory approvals outside the US as well as the anticipated FDA approval of our second generation LungFit PH and subsequent launch before the end of calendar 2026, subject to regulatory review and clearance," concluded Mr. Lisi.

Commercial Execution, Recent Highlights and Upcoming Milestones

LungFit PH Commercial Execution
Revenue increased 128% to $1.8 million for the fiscal quarter ended September 30, 2025, compared to $0.8 million for the same period last year. Growth was driven by increased demand for LungFit PH through U.S. commercial activities.
International revenue continues to build momentum, driven by recent regulatory approvals in select markets. During the quarter, the Company expanded its global LungFit PH distribution network, including new agreements in Japan, South Korea, Costa Rica, Guatemala, Panama, and El Salvador, bringing its total international coverage to 35 countries, representing a combined population of 2.8 billion people.
Appointed Robert (Bob) Goodman interim Chief Commercial Officer following the departure of David Webster. Robert, who joined the Board of Beyond Air in June 2025, has held key leadership roles at a range of high-performing organizations, including BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific, and Pfizer. His career spans public companies, private equity-backed businesses, and early-stage ventures, where he has consistently driven innovation, operational scale, and commercial success.
U.S. Patent and Trademark Office granted a patent allowance for a design patent covering the second-generation LungFit PH through 2040.
Achieves certification to demonstrate conformity of its Quality Management System with the regulatory requirements of all MDSAP participating countries, that include Australia, Brazil, Canada, European Union, Japan and United States.
The Beyond Air team will be attending the AARC Annual Congress, which is taking place December 6th to 8th in Phoenix, AZ.
Pending Regulatory Milestones
PMA supplement for the second-generation LungFit PH submitted to U.S. FDA in June 2025.
International submissions for LungFit PH remain on track with local partners.

Beyond Cancer – Solid Tumor Program – clinical stage development of an intratumoral ultra-high concentration Nitric Oxide (UNO) technology as a gas delivery of NO at high concentrations to tumors to induce an immune response.

Clinical Development Execution
Phase 1a trial (monotherapy) – Part A of the trial evaluating UNO therapy in 10 subjects with advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors at a dose of 25,000 ppm has been completed.
Latest results to date from the Phase 1a trial show median overall survival (mOS) has not yet been achieved, with median survival expected to exceed 23 months.
Phase 1b trial (combination therapy) – Will assess the intratumoral administration of 25,000 ppm low volume (LV) Nitric Oxide (UNO) in subjects with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions, who have shown disease progression or prolonged stable disease (12 weeks) after receiving a single agent anti-PD-1 containing treatment.

NeuroNOS – Autism Spectrum Disorder (ASD) Program – developing neuronal nitric oxide synthase (nNOS) inhibitors for the treatment of autism spectrum disorder ("ASD") and other neurological conditions.

U.S. FDA granted Orphan Drug Designation to its investigational therapy, BA-101, for the treatment of Glioblastoma (GBM). The Company is working closely with regulators, investigators, patient groups, and foundations to accelerate development of BA-101 toward first-in-human studies.
U.S. FDA granted Orphan Drug Designation to BA-102, an investigational therapy for the treatment of Phelan-McDermid Syndrome (PMS), a syndrome associated with ASD. The Company is in preclinical development and expects to progress to a Phase 1 first-in-human clinical trial by the end of 2026, which could provide data in 2027.

Financing & Liquidity

Closed a promissory note and equity line of credit for up to $32 million with Streeterville Capital, LLC. The agreement provides Beyond Air with a debt agreement for $12.0 million, which does not require any payment for the first year, as well as an equity line of credit for up to $20 million, which is subject to an effective registration statement and other customary conditions. This infusion of new capital equates to a September 30, 2025 proforma cash, cash equivalents, restricted cash and marketable securities balance of $22.9 million, which is expected to provide runway into calendar 2027.

Financial Results for the Fiscal Quarter Ended September 30, 2025
Revenues for the fiscal quarter ended September 30, 2025 increased 128% to $1.8 million, compared with $0.8 million for the fiscal quarter ended September 30, 2024. Gross loss of $0.3 million was recognized for the quarter ended September 30, 2025, compared with a gross loss of $1.1 million for the quarter ended September 30, 2024. The decrease in gross loss was primarily attributed to sales growth, partially offset by one-time costs required to upgrade the Company’s existing fleet of devices and provisions for excess inventory.

Research and development expenses for the fiscal quarter ended September 30, 2025 were $2.5 million compared with $4.6 million for the fiscal quarter ended September 30, 2024. The decrease of $2.1 million was primarily attributed to a decrease in salaries, stock-based compensation costs and a reduction in Gen II device development costs.

Selling, general and administrative expenses for the quarters ended September 30, 2025 and September 30, 2024 were $4.9 million and $7.2 million, respectively. The decrease of $2.3 million was primarily attributed to a reduction in salaries and stock-based compensation costs.

Other expense for the quarter ended September 30, 2025 was $0.6 million compared with other expense of $1.2 million for the quarter ended September 30, 2024. The decrease in expense of $0.6 million was primarily attributed to the prior period loss associated with the partial extinguishment of debt.

Net loss attributed to common stockholders of Beyond Air, Inc. for the quarter ended September 30, 2025 was ($7.9) million or a loss of ($1.25) per share, basic and diluted, compared to a net loss attributed to common stockholders of Beyond Air, Inc. for the fiscal quarter ended September 30, 2024 of ($13.4) million or a loss of ($5.67) per share, basic and diluted.

Net cash burn in the fiscal quarter ended September 30, 2025 was $4.7 million.

As of September 30, 2025, the Company reported cash, cash equivalents, and marketable securities of $10.7 million, and total long-term debt outstanding was $10.1 million. An additional $2.1 million related to an insider loan was recorded as long term liabilities pending finalization of terms. Synthetic royalty related debt repayment does not begin until October 2026. Subsequent to the end of the quarter, the Company secured up to $32 million in capital through a new promissory note and equity line of credit. The new $12 million note bears a 15% interest rate and matures in 24 months, with no payments due during the first 12 months.

Financial Guidance for Fiscal Year 2026
The Company updated its revenue guidance to $8 to $10 million for the fiscal year ending March 31, 2026.

Conference Call & Webcast
Monday, November 10th @ 4:30 PM ET
Domestic: 1-877-407-0784
International: 1-201-689-8560
Conference ID: 13756730
Webcast: A webcast of the live conference call can be accessed by visiting the Events section of the Company’s website (click here) or directly (click here). An online replay will be available on the Company’s website or via the direct link an hour after the call.

(Press release, Beyond Air, NOV 10, 2025, View Source [SID1234659739])

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.

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"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])

On November 10, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported it has strengthened its solid tumor pipeline by acquiring global rights to LYL273 (formerly GCC19CART), a novel autologous guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate for the treatment of metastatic colorectal cancer (mCRC) and other GCC-expressing cancers, from Innovative Cellular Therapeutics (ICT). Patients with refractory mCRC treated with LYL273 in a Phase 1 clinical trial conducted in the United States (U.S.) achieved a 67% overall response rate and an 83% disease control rate (complete and partial response plus stable disease) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with a manageable safety profile at the highest dose level studied to date. LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment.

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"We rarely see such deep and durable responses in colorectal cancer patients treated with multiple prior lines of chemotherapy. The outcomes in this initial cohort of heavily pre-treated patients are very encouraging," said Benjamin L. Schlechter, MD, Senior Physician in the Gastrointestinal Cancer Center, Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School, Boston, MA, and lead investigator in the Phase 1 clinical trial. "Patients with metastatic colorectal cancer have a tremendous need for innovations like LYL273, and I look forward to partnering with the Lyell team as we work to rapidly deliver on the potential of this innovative cellular therapy for patients with advanced colorectal cancer."

"The ability to treat solid tumors with an acceptable safety profile has become the holy grail for CAR T-cell therapy for cancer," said Richard Klausner, MD, Lyell co-founder and Board Chairman, former Director of the National Cancer Institute and co-founder and former Director of Juno Therapeutics. "These impressive early results suggest we may be on the path to finally breaking the barrier for solid cancer."

Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, and the incidence of colorectal cancer is rising in people younger than 55 years old. Approximately 53,000 people are expected to die from CRC in the U.S. in 2025. With approved therapies, only six percent of patients with mCRC in the third- or later-line setting achieve partial or complete responses to their next line of therapy, and median overall survival is generally less than 12 months. GCC is a receptor that plays a key role in the regulation of intestinal electrolyte homeostasis. It is expressed on more than 95% of colorectal cancers and a majority of pancreatic adenocarcinomas. Its expression in healthy tissue is limited to the gastrointestinal tract, where it is sequestered by tight junctions from the circulation.

U.S. Phase 1 Clinical Trial Data

Dose-dependent clinical activity in 12 patients enrolled in a Phase 1 clinical trial in the U.S. are reported as of an October 28, 2025 data cutoff date. Six patients were treated at Dose Level 1 (1 x 106 CAR T cells/kg) and six patients were treated at Dose Level 2 (2 x 106 CAR T cells/kg). All patients received a single dose of lymphodepleting chemotherapy on Day -3, including cyclophosphamide, 300 mg/m2, and fludarabine, 30 mg/m2. RECIST 1.1 classification of imaging results is per local site review.

Across both dose levels, the overall response rate was 50% (6 of 12 patients) and the disease control rate was 83%. At the highest dose tested, Dose Level 2, the overall response rate was 67% (4 of 6 patients), including one patient with a pathological complete response, one patient with complete reduction in tumor volume of the target lesions (100% partial response), and two additional patients with confirmed partial responses. For patients treated at Dose Level 2, the disease control rate was 83%, and the median progression-free survival was 7.8 months.

The incidence and severity of treatment-related adverse events were higher at Dose Level 2 than at Dose Level 1. The most common treatment-related adverse events at Dose Level 2 were cytokine release syndrome in 83% (5/6) of patients (Grade 1, 67%; Grade 2, 17%) and diarrhea in 83% (5/6) of patients (Grade 1, 33%; Grade 2, 33%; Grade 3, 17%). Immune effector cell-associated neurotoxicity syndrome occurred in 33% (2/6) of patients (Grade 2, 17%; Grade 3, 17%) and resolved rapidly with treatment. One patient experienced a dose-limiting toxicity at Dose Level 2, including Grade 3 diarrhea, Grade 4 enterocolitis and death from fungal sepsis 48 days post-infusion. No Grade 3 or higher diarrhea has occurred in the last three patients treated since establishing an optimized management protocol for diarrhea, including prophylaxis.

"Lyell was founded to realize the full potential of cell therapy for solid tumors, which make up more than 90% of all cancers. We believe LYL273 has the potential to be a transformational advance in the treatment of colorectal cancer, an area of tremendous unmet need," said Lynn Seely, MD, Lyell’s President and Chief Executive Officer. "We look forward to leveraging our expertise in T-cell biology and CAR T-cell clinical development to rapidly progress this program, as well as our two pivotal clinical trials evaluating ronde-cel for patients with relapsed or refractory large B-cell lymphoma."

LYL273 was granted Fast Track designation for the treatment of mCRC by the U.S. Food and Drug Administration. The Phase 1 clinical trial is continuing to enroll patients with refractory mCRC to determine the recommended Phase 2 dose. The next data update from this clinical trial is expected in the first half of 2026.

Clinical proof-of-concept was initially demonstrated in an investigator-sponsored clinical trial conducted in China. Data from this clinical trial in 15 patients with mCRC were published in JAMA Oncology (September 2024).

Details of the Transaction

Under the terms of the definitive license agreement, Lyell will receive exclusive global rights, outside of mainland China, Hong Kong, Macau and Taiwan, to research, develop, manufacture and commercialize LYL273. ICT will receive an upfront payment of $40 million and 1.9 million shares of Lyell common stock. ICT is also eligible to receive additional cash and equity consideration, as well as royalties on future net sales. Additional cash consideration consists of a potential $30 million clinical milestone, up to $115 million in late-stage regulatory milestones and up to $675 million in commercial sales milestones. Additional equity consideration consists of up to 1.85 million shares of Lyell common stock upon achievement of certain clinical and late-stage regulatory milestones. Tiered royalties range from mid-single digits up to 10% on annual net sales in the U.S. and low to mid-single-digit royalties on annual net sales in other countries within the licensed territory.

Following the close of the transaction, Lyell expects its cash will be adequate to fund operations into 2027 through data and progress updates from the rondecabtagene autoleucel (ronde-cel) clinical program for patients with large B-cell lymphoma and additional clinical data from the Phase 1 clinical trial of LYL273.

The transaction will have a modest impact on operating expenses for 2025. As a result of continued prudent expense management, Lyell now expects net cash use in 2025 to be between $155 million and $160 million, excluding the $40 million upfront payment from the transaction, below its previous net cash use guidance of between $175 million and $185 million.

Skadden, Arps, Slate, Meagher & Flom LLP served as legal counsel to Lyell.

Conference Call Details

Lyell’s management will host an investor conference call and webcast beginning at 8:30 AM ET today. The webcast can be accessed here.

A replay of the event and presentation materials will be archived on the Investor page of the Lyell Website following the end of the event.