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 Servier reported that it will present new and updated data from its neuro-oncology program at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) on November 19 – 23 in Honolulu, Hawaii. Presentations will demonstrate progress across Servier’s neuro-oncology portfolio, highlighting clinical and real-world evidence in isocitrate dehydrogenase (IDH) mutant glioma.

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Notably, Servier will present an analysis from the Phase 3 INDIGO trial comparing volumetric (3D) and traditional bidirectional (2D) assessment in patients with Grade 2 IDH-mutant glioma receiving VORANIGO or placebo in an oral presentation on November 22. The findings show that 3D assessments may provide a more clinically meaningful determination of progression in Grade 2 glioma trials, potentially impacting future trial design and endpoint selection.

In addition, Servier will also share results from the Phase 1b part of an ongoing Phase 1b/2 study evaluating VORANIGO in combination with temozolomide in patients with newly diagnosed Grade 4 IDH mutant astrocytoma on November 22. These data represent the first published data evaluating the safety of combining an IDH inhibitor with current standard of care chemotherapy in higher grade IDH mutant gliomas.

"As a pioneer in targeted therapies for brain tumors, Servier – working with the neuro-oncology community – is using our unmatched clinical trial datasets to better understand how these medicines affect tumor growth," said Islam Hassan, Global Head of Development-Neuro-Oncology & Senior Director, LS/LCM at Servier. "The critical insights presented at SNO will enable efficient clinical trial designs across all IDH-mutant glioma grades, including in combination with temozolomide in higher grade settings, to help us deliver potential new treatment options faster to patients who are eagerly awaiting them, all while upholding the highest level of evidence."

(Press release, Servier, NOV 10, 2025, View Source [SID1234659742])

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])

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:

•
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:

•
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:

•
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 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 annual meeting, Tiumbio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company dedicated to developing novel therapies for rare and intractable diseases, reported the interim Phase II clinical data for its "first-in-class" Tosposertib (TU2218), a dual inhibitor against TGFβ type I receptor (TGFβRI /ALK5) and VEGFR2. The study evaluated Tosposertib in combination with MSD’s Keytruda (pembrolizumab) as a first-line therapy for patients with recurrent/metastatic(r/m) head and neck squamous cell carcinoma (HNSCC).

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Tosposertib (TU2218) is a highly potent, oral dual inhibitor designed to block the signaling pathways of transforming growth factor-beta (TGF-β) and vascular endothelial growth factor (VEGF), two critical mediators of tumor growth and metastasis. This novel drug candidate was discovered and developed by Tiumbio to enhance the therapeutic efficacy of immune-oncology agents such as Keytruda.

Hun-Taek Kim, Ph.D., CEO of Tiumbio, stated "The data presented at SITC (Free SITC Whitepaper) mark an important milestone, demonstrating that the strong antitumor activity continues to be sustained with accumulating clinical data and ongoing follow-up." He added, "The combination of Tosposertib (TU2218) and Keytruda has shown meaningful potential and value as an immuno-oncology therapy capable of overcoming the limitations of existing immunotherapies or immunotherapy/chemotherapy combinations in recurrent or metastatic head and neck cancer."

The company plans to actively advance patient enrollment for the Tosposertib combination therapy and expand its global clinical trial sites to accelerate the studies required for regulatory approval. Through these efforts, the company aims to provide patients with recurrent or metastatic head and neck cancer earlier access to treatment and, in collaboration with global partners, continue to pursue combination trials and broader indication expansion.

Tosposertib (TU2218: TGF-β/VEGF dual inhibitor): Solid Tumors

Poster title: Phase 2 trial of TU2218, TGFβ-RI and VEGF-R2 dual inhibitor in combination with Pembrolizumab in patients with head and neck squamous cell carcinoma (HNSCC)

Observations in the poster presentation include:

As of July 31, 2025 data cutoff date, 27 patients (pts) were enrolled
The efficacy-evaluable population consisted of 17 patients who had received prior treatments such as surgery, chemotherapy, or radiotherapy.
Response rates overall (N=17): 70.6%, including 9 confirmed partial responses (PRs) and 3 unconfirmed PRs by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment, including
1L : Response rates overall (N=11) : 72.7% (8/11), including 6 confirmed partial responses (PRs) and 2 unconfirmed PRs
2L+ : Response rates overall (N=6) : 66.7% (4/6), including 3 confirmed partial response (PRs) and 1 unconfirmed PRs
Responses observed across PD-L1 levels (CPS 1-19: 66.7% [8/12]; CPS≥20: 80% [4/5])
At the time of data cutoff, 17 patients of the 27 enrolled, remained on treatment.
Median follow up of 2.6 months for the 27 patients
In 27 patients the combination was well tolerated and no significant overlapping toxicities with pembrolizumab were observed.
Treatment-emergent adverse events (TEAEs) were reported in 26 pts
Most were Grade (G) 1 or 2 in severity (no G5 were observed)
G≥3 TEAEs occurred in 11 patients (40.7%)
Most common adverse events included rash and mucositis.
No cases of major bleeding or cardiovascular toxicities-safety concerns typically associated with VEGF or TGF-β inhibition- were observed

(Press release, TiumBio, NOV 10, 2025, View Source [SID1234659743])