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.

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 INOVIO (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 its financial results for the third quarter of 2025 and provided an update on recent company developments.

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"I’m very pleased to report that we’ve completed the rolling submission of our BLA for lead candidate INO-3107. We believe every patient deserves a treatment that reduces exposure to surgery and INO-3107 has the potential to meet that significant need in the RRP community. The majority of patients in our Phase 1/2 trial needed fewer surgeries after treatment and showed continued improvement through Year 2 without additional doses, and without surgical interventions during the treatment window to maintain minimal residual disease as required by other treatment modalities," said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. "As INOVIO works toward a potential approval for INO-3107 in mid-2026, we’re also working to advance our next generation DNA medicine candidates. Landmark proof-of-concept data on our DMAb technology was recently published in Nature Medicine and we are preparing for an upcoming presentation of promising pre-clinical data from our DNA-encoded protein technology (DPROT) at the World Federation of Hemophilia Global Forum. We look forward to sharing more on the company’s progress in the coming months."

Operational Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
INOVIO completed the rolling submission of its BLA for DNA immunotherapy candidate INO-3107 for the treatment of RRP in adults. INOVIO submitted the BLA under the FDA’s accelerated approval program and has requested a priority review, which if granted, is expected to be completed within six months following file acceptance. Commercial preparations continue to advance for a potential launch in mid-2026. If approved, INO-3107 would be INOVIO’s first commercial product and the first DNA medicine available in the United States.

INOVIO plans to conduct a confirmatory trial and expects to begin enrolling patients during the BLA review period. The trial is expected to be conducted at approximately 20 sites across the United States.

Peer-reviewed data from a retrospective study (RRP-002) investigating the long-term clinical and safety response of patients treated with INO-3107 were published online in The Laryngoscope. The data demonstrate that a majority of patients experienced continued improvement beyond the initial 12-month study period of the previously published Phase 1/2 trial (RRP-001), as measured by the number of surgical procedures needed after treatment with INO-3107. Since our last report, INOVIO has also presented key data at several scientific conferences, including the American Academy of Otolaryngology – Head and Neck Surgery Annual Meeting, the European Society for Medical Oncology Annual Congress, and the 37th International Papillomavirus Society Conference. Highlights from the data include:
•81% (26/32) of patients experienced a reduction of one or more surgeries at Year 1 post-treatment
•By the end of Year 2, 91% (21/23) of evaluable patients continued to experience a reduction of one or more surgeries. Only two patients had not yet responded to treatment with INO-3107
•INO-3107 demonstrated continued clinical benefit, with a persistent decline in the mean number of surgeries through Year 2 post-therapy: A 78% reduction in mean annual surgeries was seen at Year 2 compared to the 1 year pre-treatment period (0.9, n=28 vs 4.1, n=32)
•Clinical response was not dependent upon low viral loads, molecular subtype or other elements of the papilloma microenvironment

Next Generation DNA Medicine Candidates
Results from a Phase 1 proof-of-concept trial evaluating next generation DMAbs for COVID-19 were published online in Nature Medicine, demonstrating the technology’s potential as a long-acting, scalable and tolerable alternative to traditional monoclonal antibody therapies. Interim pharmacokinetic results were previously available as a preprint on Research Square. The study is being led by The Wistar Institute in collaboration with INOVIO, AstraZeneca, and clinical investigators at the Perelman School of Medicine at the University of Pennsylvania.

This was the first demonstration that monoclonal antibodies, complex proteins, can be durably and tolerably expressed in humans. INOVIO is building on this research to evaluate in vivo therapeutic protein production and will be presenting promising preclinical data from its DPROT program at the upcoming World Federation of Hemophilia Global Forum. This technology aims to address some of the shortcomings of conventional therapeutic protein replacement treatments including gene therapy approaches.

General Corporate
INOVIO remains focused on financial discipline and directing resources to advance the INO-3107 program towards commercialization and a potential launch date in mid-2026.

Third Quarter 2025 Financial Results

•Research and Development (R&D) Expenses: R&D expenses for the three months ended September 30, 2025, decreased to $13.3 million from $18.7 million for the same period in 2024. The decrease was primarily the result of lower drug manufacturing, clinical study and other expenses related to INO-3107 and lower expensed inventory, among other variances.

•General and Administrative (G&A) Expenses: G&A expenses decreased to $7.9 million for the three months ended September 30, 2025, from $8.6 million for the same period in 2024. The decrease was primarily related to a decrease in employee and consultant compensation, including stock-based compensation, among other variances.

•Total Operating Expenses: Total operating expenses decreased to $21.2 million for the three months ended September 30, 2025, from $27.3 million for the same period in 2024.

•Net Loss: Net loss for the three months ended September 30, 2025, increased to $45.5 million, or $0.87 per basic and diluted share, from a net loss of $25.2 million, or $0.89 per basic and diluted share, for the three months ended September 30, 2024.

The increase in net loss for the period was primarily driven by a $22.5 million non-cash loss on fair value adjustment related to our warrant liabilities. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss.

The loss from operations prior to other income (expenses) for the quarter ended September 30, 2025, was $21.2 million, or $0.41 per share, as compared with $27.3 million, or $0.97 per share, for the quarter ended September 30, 2024.

•Shares Outstanding: As of September 30, 2025, INOVIO had 53.6 million common shares outstanding and 94.5 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding common stock warrants, stock options, restricted stock units and convertible preferred stock.

•Cash, Cash Equivalents and Short-term Investments: As of September 30, 2025, cash, cash equivalents and short-term investments were $50.8 million, compared to $94.1 million as of December 31, 2024.

INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended September 30, 2025, which can be accessed at: View Source

Cash Guidance

INOVIO estimates its current cash, cash equivalents and short-term investments balances will support the company’s operations into the second quarter of 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the fourth quarter of 2025. These projections do not include any further capital-raising activities that INOVIO may undertake.

Conference Call / Webcast Information
INOVIO’s management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

(Press release, Inovio, NOV 10, 2025, View Source [SID1234659718])

On November 10, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed.

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The planned confirmatory Phase 3 trial, TELLOMAK 3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sézary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive lacutamab or mogamulizumab. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.

Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. With this feedback from FDA, the Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK 3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, once the Phase 3 trial is underway.

"This important regulatory milestone with the FDA marks a key step forward for the lacutamab program," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "Building on robust Phase 2 data from TELLOMAK, this milestone brings us one step closer to our next goal, submitting for accelerated approval in Sézary syndrome once the Phase 3 trial is underway. We remain deeply committed to advancing this differentiated therapy for patients with CTCL, while creating meaningful value for our shareholders."

"We are pleased to reach this important milestone for the lacutamab program as we prepare to initiate the confirmatory Phase 3 study, TELLOMAK 3," said Sonia Quaratino, Chief Medical Officer of Innate Pharma. "The efficacy and safety data from the TELLOMAK Phase 2 trial suggest that lacutamab has the potential to be a game changer in the treatment of CTCL, an orphan disease with a high unmet medical need. Our expert clinical team looks forward to collaborating with CTCL investigators and regulators to start the Phase 3 trial in due time."

About lacutamab

Lacutamab is a first-in-class anti-KIR3DL2 antibody, currently developed in cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). CTCL is a group of rare non-Hodgkin’s lymphomas that develop in the skin and severely affect patients’ quality of life. Sezary syndrome (SS) is a rare and aggressive leukemic form with poor survival, while mycosis fungoides (MF) is the most common subtype, with advanced stages associated with poor outcomes.

Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome.

(Press release, Innate Pharma, NOV 10, 2025, View Source [SID1234659717])

On November 10, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported an update on recent progress with its IMNN-001 development program for the treatment of newly diagnosed advanced ovarian cancer, including a review of positive data from the Company’s Phase 2 OVATION 2 Study and the minimal residual disease (MRD) study conducted in partnership with Break Through Cancer. The program will also include updates on trial activation and patient enrollment in the Company’s ongoing Phase 3 OVATION 3 pivotal trial.

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"IMNN-001 represents a potential landmark breakthrough in the treatment of newly diagnosed ovarian cancer in combination with standard of care chemotherapy. Data thus far indicate that our novel immunotherapy has the potential to represent a major advance in treatment that can make a meaningful difference in the lives of thousands of women," said Stacy Lindborg, Ph.D., President and CEO of IMUNON. "No other frontline ovarian cancer treatment has shown improvement in overall survival, which of course is the ultimate goal. We are very encouraged to see results from our Ovation 2 Study demonstrate that IMNN-001 treatment plus chemotherapy is associated with a 13-month improvement in overall survival with a highly favorable benefit-risk profile. The results from this landmark trial strongly support the advancement of IMNN-001 into our Phase 3 trial. We are excited to share the latest updates in today’s event and to review what’s ahead for this program."

R&D Day Featured Speakers and Program Highlights:

Premal H. Thaker, M.D., Washington University School of Medicine, will discuss the significant continuing unmet needs in ovarian cancer, a devastating disease where patient outcomes and frontline standard of care treatment have not changed for about 30 years, and the promise IMNN-001 brings to these patients and clinicians. She will highlight the data from the Phase 2 OVATION 2 clinical trial, with results including:
Broad impact observed with IMNN-001 treatment on important cancer-fighting cytokines, effectively turning the tumor microenvironment from "cold" to "hot" by activating both innate and adaptive immune systems, renewing the elusive promise of an immunotherapy for ovarian cancer.
Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001.
The remarkable median 13-month overall survival (OS) benefit observed with IMNN-001 plus standard of care (SoC) chemotherapy, an increase that is considered clinically meaningful compared to SoC alone.
Amir Jazaeri, M.D., University of Texas MD Anderson Cancer Center, will discuss safety, tolerability and translational insights from the Phase 2 MRD study of IMNN-001, including:
Rationale for the trial and the importance of frontline therapy as the best opportunity to achieve a cure for ovarian cancer.
New translational data that clearly show IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, which then induces a robust response and tumor microenvironment remodeling.
New data further supporting the highly favorable benefit-risk and tolerability profile of IMNN-001.
The positive tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab and in the maintenance setting.
Giorgio Paulon, Ph.D., Berry Consultants, LLC, will review the Phase 2 and ongoing Phase 3 trial designs and the strength of evidence for IMNN-001 from a statistical perspective. He will highlight the well-precedented nature of the Phase 3 design with the FDA, which leverages an innovative, adaptive, event-driven approach aligned with prior successful oncology trials that resulted in full approval by FDA based on interim analyses of overall survival. This foundation, supported by conservative power assumptions drawn from Phase 2 data, strong simulation modeling and robust statistical properties, underpins the Phase 3 trial’s high probability for success.

Douglas V. Faller, M.D., Ph.D., IMUNON, will share new data further demonstrating that IMNN-001 shifted the balance in favor of immune stimulation, remodeling the tumor microenvironment in favor of anti-tumor responses, which is established to be associated with better prognosis. He will share the rapid progress to-date on the Phase 3 trial of IMNN-001, including expansion to additional sites and enrollment exceeding the Company’s expectations, strong levels of support and interest from investigators and the scientific community, and key clinical and other milestones for the company moving forward.
A live webcast of the event and presentation materials will be available on the "Scientific Presentations" page of the IMUNON website at View Source

(Press release, IMUNON, NOV 10, 2025, View Source [SID1234659716])