On November 10, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported positive clinical and translational data presented at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The presentations highlight immune-driven mechanisms and biomarkers that explain strong clinical activity of the Company’s investigational HPV16-targeted immunotherapy PDS0101 and its novel, investigational immunocytokine PDS01ADC.

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The studies were performed as part of PDS Biotech’s collaborative research and development agreement (CRADA) with the National Cancer Institute (NCI) Center for Cancer Research (CCR). Presentations at SITC (Free SITC Whitepaper) 2025 included one rapid oral abstract, recognized among the top 150 abstracts of the meeting, and two poster presentations.

"The data presented at SITC (Free SITC Whitepaper) further validate the scientific underpinnings of our immunotherapy platforms and confirm that our development approach is achieving the intended immunological and clinical effects," said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech. "These findings provide a deeper understanding of how our immunotherapies are generating such promising results in advanced cancers. The ability to measure and model these immune effects enhances confidence in our programs and supports our regulatory strategy to advance these novel, investigational immunotherapies toward commercialization as efficiently as possible for patients with difficult-to-treat cancers."

PDS0101) Data Highlights

Rapid Oral Abstract Presentation Number: 37
Title: Baseline and early changes in serum proteomic profiles predict anti-tumor activity in patients with advanced HPV-associated malignancies treated with novel combination immunotherapy
Authors: Megan Lynch, Meghali Goswami, Charalampos Floudas, Julius Strauss, Yo-Ting Tsai, Jennifer Marte, James Gulley, Jeffrey Schlom, Renee Donahue
Recognition: Selected among the Top 150 abstracts at SITC (Free SITC Whitepaper) 2025

Key findings:

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Analysis of 50 patients with advanced HPV16-positive cancers treated with the combination of PDS0101, PDS01ADC and an immune checkpoint inhibitor showed strong and broad immune activation, with increases in multiple critical pro-inflammatory cytokines that are essential in recruiting T cells and enhancing their potency.

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Quantitative measurements of various immunological proteins in the blood were found to predict clinical benefit with good accuracy.

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The data supports continued evaluation of these biomarkers obtained by blood sampling, and prospective validation of the developed predictive models in future clinical trials.

These translational findings further reinforce the strong clinical activity seen with PDS0101 combinations across three phase 2 trials. By establishing a clear link between specific immune signatures and clinical response, the data provide strong rationale for future biomarker-guided optimization of PDS0101-based immunotherapy combinations.

PDS01ADC (IL-12 tumor-targeting immunocytokine) Data Highlights

Abstract Number: 47
Title: A tumor-targeting IL-12 immunocytokine therapy in patients with advanced solid tumors increases peripheral natural killer (NK) cells with phenotypes associated with increased tumor cell lysis
Authors: Stephanie Pitts, Nicole Toney, Jennifer Marte, James Gulley, Jeffrey Schlom, Renee Donahue

Key findings:

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PDS01ADC monotherapy promoted generation of multi-functional NK cells that were associated with induction of a clinical response in advanced treatment-resistant patients with solid tumors.

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Specific types of NK cells associated with effective killing were seen to increase in advanced cancer patients with solid tumors upon treatment with PDS01ADC, and the increases were associated with an improved clinical response.

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Several types of NK cells associated with poor anti-tumor response were seen to decrease with PDS01ADC therapy, and these decreases were associated with an improved clinical response.

Collectively, these results demonstrate immune reprogramming of NK cells toward killer phenotypes upon treatment with PDS01ADC and provide mechanistic support for PDS01ADC-based combination immunotherapy strategies.

Abstract Number: 168
Title: Increases in peripheral memory T cells with self-renewing properties in patients with advanced solid tumors treated with tumor-targeting IL-12 immunocytokine therapy
Authors: Meghali Goswami, Carolina Celades, Christine Minnar, Asma Khelifa, Lisa Poppe, Dara Bracken-Clarke, Nicole Toney, Megan Lynch, Jennifer Marte, Sofia Gameiro, James Gulley, Jeffrey Schlom, Renee Donahue

Key findings:

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PDS01ADC monotherapy increased the quantity of stem-like memory, CD8 (killer) and CD4 (helper) T cells that had self-replicating properties in patients with advanced solid tumors

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In 28 patients with advanced solid tumors, increases in stem-like T cells was associated with stabilization of disease
These translational findings show that PDS01ADC promotes specific types of self-replicating T cells that enhance the durability of anti-tumor immunity.

"The immune signatures we observed with both PDS0101 and PDS01ADC deepen our understanding of how these therapies generate a powerful anti-tumor immune response. We are seeing broad immune activation, including early natural killer cell responses and expansion of durable, stem-like memory T cells, features that are critical for long-term tumor control," said Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. "The translational data presented at SITC (Free SITC Whitepaper), including early immune biomarker signatures, HPV ctDNA dynamics, and coordinated NK and T cell activation validate our platforms scientifically. These insights will also help us design future studies and combination approaches that fully leverage each therapy’s unique mechanism of action."

Building on these findings, PDS Biotech continues to advance the development of PDS0101 and PDS01ADC. The company is developing PDS0101 in combination with Keytruda (pembrolizumab) in a phase 3 clinical trial of HPV16-positive recurrent/metastatic head and neck cancer. In parallel, PDS Biotech is advancing PDS01ADC via NCI-led Phase 2 clinical trials under PDS Biotech’s CRADA with the NCI in metastatic colorectal cancer, cholangiocarcinoma, biochemically recurrent prostate cancer, and castration resistant and castration sensitive prostate cancer. Collectively, these data presented at SITC (Free SITC Whitepaper) 2025 strengthen the scientific foundation of the Company’s immunotherapy platforms and support continued progress toward future regulatory and clinical milestones.

(Press release, PDS Biotechnology, NOV 10, 2025, View Source [SID1234659723])

On November 10, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported financial and operating results for the third quarter ended September 30, 2025.

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"We have made significant progress advancing our programs this quarter, highlighted by the initiation of the Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in the frontline setting and the presentation of compelling data at ESMO (Free ESMO Whitepaper) that further positions palazestrant to become a potential best-in-class backbone endocrine therapy for ER+/HER2- metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our clinical trial agreement with Pfizer to combine palazestrant with atirmociclib further underscores our confidence in palazestrant’s activity in combination with other agents in the metastatic setting."

Bohen continued, "Enrollment in the OPERA-01 trial evaluating palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer continues to progress well and we remain on track for top-line data in the second half of next year. The Phase 1/2 study of our KAT6 inhibitor, OP-3136, recently expanded into combinations with fulvestrant and palazestrant and continues to benefit from strong investigator interest. As we look ahead to 2026, we remain focused on sustaining positive momentum across the business, transforming the breast cancer treatment paradigm, and bringing palazestrant to market."

Recent Progress

Announced a clinical trial collaboration and supply agreement with Pfizer to evaluate the safety and combinability of palazestrant plus atirmociclib, Pfizer’s investigational, highly selective-CDK4 inhibitor, in a Phase 1b/2 study in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.
Initiated the OPERA-02 Phase 3 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer.
Presented updated data from the Phase 1b/2 study of palazestrant plus ribociclib at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, demonstrating encouraging activity in both ESR1 mutant and wild-type patients.
Continued enrollment in the OPERA-01 Phase 3 trial of palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer.
Advanced the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136, as a monotherapy and in combination with fulvestrant and palazestrant, in participants with advanced solid tumors.

Anticipated Upcoming Events

Initiate the Phase 1b/2 study evaluating palazestrant with atirmociclib in ER+/HER2- metastatic breast cancer in Q4 2025.
Present trial-in-progress poster entitled "OPERA-02: a phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2- advanced breast cancer" at the San Antonio Breast Cancer Symposium (SABCS) in December 2025.
Report initial clinical results for OP-3136 in mid-2026.
Report top-line data from OPERA-01 in the second half of 2026.

Third Quarter 2025 Financial Results
Cash, cash equivalents, and marketable securities of $329.0 million as of September 30, 2025.

Net loss for the quarter ended September 30, 2025 was $42.2 million, as compared to $34.6 million for the quarter ended September 30, 2024. The increase in net loss for the third quarter was primarily related to increased spending on research and development activities as a result of the ongoing late-stage clinical trials for palazestrant and the advancement of OP-3136, partially offset by higher interest income earned from marketable securities.

GAAP research and development (R&D) expenses were $40.0 million for the quarter ended September 30, 2025, as compared to $33.2 million for the quarter ended September 30, 2024. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as Olema continues to advance palazestrant through late-stage clinical trials, and the advancement of OP-3136, partially offset by decreases in stock-based compensation expense of $1.7 million.

Non-GAAP R&D expenses were $37.4 million for the quarter ended September 30, 2025, excluding $2.6 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $28.9 million for the quarter ended September 30, 2024, which excluded $4.3 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP general and administrative (G&A) expenses were $5.9 million for the quarter ended September 30, 2025, as compared to $4.4 million for the quarter ended September 30, 2024. The increase in G&A expenses was primarily due to corporate-related costs, including increases in stock-based compensation expense of $0.3 million.

Non-GAAP G&A expenses were $4.3 million for the quarter ended September 30, 2025, excluding $1.7 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended September 30, 2024, excluding $1.3 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

(Press release, Olema Oncology, NOV 10, 2025, View Source [SID1234659722])

On November 10, 2025 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biotechnology company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported financial results for the third quarter ended September 30, 2025.

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"This quarter marks an important milestone for Nkarta as we advance the NKX019 clinical program to treat autoimmune diseases," said Paul J. Hastings, Chief Executive Officer of Nkarta. "Following productive engagement with the FDA, we streamlined enrollment across our Ntrust-1 and Ntrust-2 clinical trials under a combined iDSMB, which has authorized initiation of the second dose-escalation cohort. This unified approach, combined with the ability to dose multiple patients simultaneously at each dose level and the removal of a patient-by-patient stagger, strengthens the efficiency of our trial enrollment and underscores the consistency of NKX019’s emerging safety profile.

"With the modification of our lymphodepletion regimen to include both fludarabine and cyclophosphamide prior to treatment with NKX019, we are now seeing complete B-cell depletion in all patients treated to date, compared with partial B-cell depletion observed with patients receiving cyclophosphamide alone. Now that our study design modifications have been cleared by the FDA and institutional review boards, we’re enrolling patients with the new regimen at the higher dose.

"We plan to present data with our investigators at a medical conference in 2026. In the interim, we remain focused on disciplined clinical execution. With a strong balance sheet projected to fund operations into 2029, we are now poised to meaningfully advance our clinical program in this challenging capital environment."

NKX019 Clinical Program Progress and Upcoming Milestones

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Following engagement with the U.S. Food and Drug Administration, the patient-by-patient stagger was eliminated, accelerating the ability to dose escalate
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Protocol amendments now allow for simultaneous dosing of multiple participants in parallel within each dose cohort.
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Ntrust-1 and Ntrust-2 enrollment process was streamlined to permit data from both studies to be utilized by a combined, iDSMB to inform dose escalation decisions.
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After unanimous clearance from the combined iDSMB, enrollment has begun in the second dose-escalation cohort.
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NKX019 clinical programs in autoimmune diseases continue to enroll patients. This includes Ntrust-1, Ntrust-2, and two investigator-sponsored trials.
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Preliminary data from the Ntrust-1 and Ntrust-2 clinical trials are expected to be presented at a medical conference in 2026.

Third Quarter 2025 and Recent Financial Highlights

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Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $316.5 million as of September 30, 2025.
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Research and development (R&D) expenses were $20.2 million for the third quarter of 2025. Non-cash stock-based compensation expense included in R&D expense was $0.5 million for the third quarter of 2025.
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General and administrative (G&A) expenses were $7.1 million for the third quarter of 2025. Non-cash stock-based compensation expense included in G&A expense was $1.2 million for the third quarter of 2025.
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Net loss was $21.7 million, or $0.29 per basic and diluted share, for the third quarter of 2025. This net loss includes non-cash charges of $3.5 million that consisted primarily of share-based compensation, right-of-use asset impairment and depreciation expenses.

Financial Guidance

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Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2029.

About the Ntrust℠ Clinical Trials in Autoimmune Disease

Ntrust-1 (NCT06557265) and Ntrust-2 (NCT06733935) are multi-center, open label, dose escalation clinical trials that build on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its ability to enable durable remissions via a "reset" of the immune system through the elimination of pathogenic B cells.

The Ntrust trials are enrolling up to 12 patients per dose level per disease indication across lupus nephritis, primary membranous nephropathy, systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis.

In both studies, patients now receive a three-dose cycle of NKX019 on Days 0, 3, and 7 following lymphodepletion with fludarabine and cyclophosphamide or cyclophosphamide alone, if they have significant cytopenia at baseline. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval. Patients in Ntrust-1 may also receive additional cycles, if necessary, to restore response or enable a deeper response.

About the Investigator-Sponsored Clinical Trial of NKX019 for Generalized Myasthenia Gravis
The single-arm, open-label Phase 1 investigator-sponsored clinical trial is designed to enroll patients with generalized myasthenia gravis and will evaluate safety and clinical outcomes. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are planned. Patients receive 3 doses of NKX019 following lymphodepletion. The clinical trial is being co-led by Ali A. Habib, M.D., Clinical Professor of Neurology at the University of California, Irvine, and other investigators.

About the Investigator-Sponsored Clinical Trial of NKX019 for Systemic Lupus Erythematosus

The single-center, single-arm, open-label Phase 1 investigator-sponsored clinical trial (NCT06518668) is designed to enroll up to 6 patients with systemic lupus erythematosus, regardless of renal involvement, and will evaluate safety and clinical outcomes in a potentially different population than Ntrust-1. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are planned. Patients receive 3 doses of NKX019 following lymphodepletion. The clinical trial is being led by Anca D. Askanase, M.D., M.P.H., Director, Lupus Center at Columbia University Irving Medical Center and the Director of Rheumatology Clinical Trials.

About NKX019

NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease. Nkarta is evaluating NKX019 in multiple autoimmune conditions.

(Press release, Nkarta, NOV 10, 2025, View Source [SID1234659721])

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])