On March 16, 2026 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 fourth quarter and full year ended December 31, 2025.

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"2025 was a year of strong execution across the business as we advanced palazestrant as a differentiated endocrine therapy across multiple regimens, highlighted by continued enrollment and strong investigator interest in our OPERA-01 and OPERA-02 trials," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our earlier-phase combination studies with palazestrant continue to advance and we are pleased to have initiated a Phase 1b/2 study with atirmociclib in collaboration with Pfizer, further demonstrating palazestrant’s potential as the combination endocrine therapy of choice in the metastatic setting."

Bohen continued, "In November, we strengthened our balance sheet through a public offering that generated gross proceeds of approximately $218.5 million, enabling us to fund operations through numerous expected value-creating events with palazestrant. With initial clinical results from OP-3136 anticipated in Q2 2026, top-line data from OPERA-01 expected in the fall of this year, and commercial launch preparations underway for a potential approval in late 2027, we are entering an exciting chapter in Olema’s history. We remain focused on transforming the metastatic breast cancer treatment paradigm and delivering meaningful new treatment options to patients living with breast cancer and beyond."

Recent Progress

Initiated the Phase 1b/2 study evaluating palazestrant in combination with atirmociclib in estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer in collaboration with Pfizer.
Presented a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or metastatic breast cancer at the San Antonio Breast Cancer Symposium (SABCS) 2025.
Continued enrollment in 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.
Completed an underwritten public offering of an aggregate of 11,500,000 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares, resulting in gross proceeds of approximately $218.5 million, before deducting underwriting discounts and commissions and estimated offering expenses.
Anticipated Upcoming Events

Report initial clinical results for OP-3136 in Q2 2026 at a major medical conference.
Report top-line data from the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in second- and third-line (2/3L) ER+/HER2- metastatic breast cancer in the fall of 2026.
Fourth Quarter and Full Year 2025 Financial Results
Cash, cash equivalents, and marketable securities as of December 31, 2025, were $505.4 million.

Net loss for the quarter and year ended December 31, 2025 was $46.1 million and $162.5 million, respectively, as compared to $33.6 million and $129.5 million for the quarter and year ended December 31, 2024, respectively. The increase in net loss for the fourth quarter was primarily related to increased spending on clinical development and research activities as a result of 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 $43.2 million and $157.7 million for the quarter and year ended December 31, 2025, respectively, as compared to $32.3 million and $124.5 million for the quarter and year ended December 31, 2024. The increase in R&D expenses was primarily related to increased spending on clinical operations and development-related activities as Olema continues to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and personnel-related costs, partially offset by a decrease in non-cash stock-based compensation expense.

Non-GAAP R&D expenses were $40.6 million and $145.5 million for the quarter and year ended December 31, 2025, respectively, excluding $2.6 million and $12.2 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $27.7 million and $108.0 million for the quarter and year ended December 31, 2024, respectively, excluding $4.6 million and $16.5 million non-cash stock-based compensation expense, respectively. 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 G&A expenses were $6.9 million and $21.0 million for the quarter and year ended December 31, 2025, respectively, as compared to $4.5 million and $17.7 million for the quarter and year ended December 31, 2024. The increase in G&A expenses was primarily due to increased spending on corporate-related costs.

Non-GAAP G&A expenses were $5.2 million and $15.6 million for the quarter and year ended December 31, 2025, respectively, excluding $1.7 million and $5.4 million non-cash stock-based compensation expense, respectively. Non-GAAP G&A expenses were $2.8 million and $11.7 million for the quarter and year ended December 31, 2024, excluding $1.7 million and $6.0 million non-cash stock-based compensation expense, respectively. 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, MAR 16, 2026, View Source [SID1234663572])

On March 16, 2026 NovaBridge Biosciences (Nasdaq: NBP) ("NovaBridge" or the "Company"), a global biotechnology platform company committed to accelerating access to innovative medicines, reported that based on a productive Type B meeting with the U.S. Food and Drug Administration (the "FDA") and receipt of written minutes, NovaBridge has secured FDA alignment on givastomig’s potential eligibility for an accelerated approval pathway in 1L Her2-, CLDN 18.2+, PD-L1+ GEC patients, building on positive data from the Phase 1b combination trial. The Company intends to initiate a registrational Phase 3 trial, in combination with immunochemotherapy, as early as Q4 2026. Final study design details will be discussed with FDA.

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"We are thrilled to receive the positive feedback from FDA confirming givastomig’s eligibility for an accelerated approval pathway," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. "This important regulatory milestone builds on compelling Phase 1b givastomig results that showed robust efficacy and favorable overall tolerability, with marked improvement relative to historical benchmarks for the standard of care in cross trial comparisons. Givastomig has the potential to be a first-in-class and best-in-class Claudin 18.2 therapeutic for gastric cancer in combination with immunochemotherapy. We are looking forward to continuing our discussions with FDA and to bringing givastomig to patients as quickly as possible."

About the Givastomig Phase 1b Dose Escalation and Expansion Combination Study in 1L Gastric Cancer

The Phase 1b dose expansion data (per the Company’s January 6, 2026 press release) showed that givastomig, dosed at 8 mg/kg every two weeks (Q2W) and 12 mg/kg Q2W, produced:

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Robust efficacy, with a 75% objective response rate (ORR) (77% ORR observed at 8 mg/kg, 73% ORR observed at 12 mg/kg, n=52 evaluable)
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Responses across a wide range of PD-L1 and CLDN18.2 expression levels
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Durable responses with 16.9-month mPFS (median progression free survival) and an 82% 6-month landmark PFS rate (n=53 evaluable)
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Good overall tolerability in combination with immunochemotherapy, without dose dependent toxicity
Detailed Phase 1b expansion data are expected to be presented at a major medical conference in H2 2026.

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive (CLDN 18.2+) tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2+ gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of the proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

(Press release, NovaBridge Biosciences, MAR 16, 2026, View Source [SID1234663571])

On March 16, 2026 Nerviano Medical Sciences S.r.l. ("NMS"), a global oncology-focused biopharmaceutical company, reported the presentation of two Trial-in-Progress posters featuring Itareparib (NMS-03305293) at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress 2026, taking place March 16–18, 2026 in Paris, France.

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The presentations highlight ongoing clinical studies of Itareparib, NMS’s non-trapping, PARP1-specificinhibitor, the only third-generation inhibitor in clinical development. Itareparib is highly brain- and tumor-penetrant, providing an advantage for widely metastatic disease. Itareparib is being studied in combination with established DNA-damaging therapies in two areas of high unmet medical need: recurrent non-BRCA-mutated ovarian cancer and relapsed extensivestage small cell lung cancer (ES-SCLC), including patients with brain metastases.

The posters are:

Poster 57TiP – Phase 1a/1b Study of NMS-03305293 (Itareparib), a Brain-Penetrant, Non-Trapping PARP1- Selective Inhibitor, in Combination with Topotecan in Recurrent HR-Proficient / Refractory Ovarian Cancer.
Poster 58TiP – Poster 58TiP – PARPA-293-004: Phase 1b Study of NMS-03305293 (Itareparib), a Brain-Penetrant, Non-Trapping PARP1-Selective Inhibitor, in Combination with Temozolomide in Relapsed Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
Both studies are open and actively recruiting:

Non-BRCA-mutated ovarian cancer study: NCT06930755
ES-SCLC study: NCT06931626
"These studies reflect our strategy of advancing Itareparib in combination settings where conventional PARP1 approaches have historically been constrained," said Lisa Mahnke, MD PhD, Group CMO. "We believe the differentiated profile of Itareparib has the potential to broaden the use of PARP1 biology beyond traditional BRCA-mutated settings and into larger patient populations through rational combinations with DNA-damaging therapies."

Ovarian cancer and ES-SCLC remain aggressive malignancies with significant unmet need, particularly in relapsed or refractory settings where patients often face limited treatment options and poor outcomes. Through these studies, NMS is evaluating Itareparib for its potential to enhance the activity of widely used chemotherapeutic backbones while maintaining a combination-enabling tolerability profile.

Itareparib is currently being developed across multiple tumor settings, with near-term clinical readouts expected from its ongoing combination programs.

About Itareparib
Itareparib is a novel PARP1 inhibitor, designed to be used in combination, and distinguished by a non-trapping mechanism of action as shown preclinically with high potency, PARP1 selectivity and brain penetrance. Clinically (Geurts et al ENA 2023), the profile improves on poor bone marrow features of trapping PARP1 inhibitors (Yap et al AACR (Free AACR Whitepaper) 2024) and thus removes traditional barriers to combining a DNA damage repair inhibitor with a DNA damaging agent in non-BRCA-mutated tumors.

(Press release, Nerviano Medical Sciences, MAR 16, 2026, View Source [SID1234663570])

On March 16, 2026 Nerviano Medical Sciences S.r.l. (NMS), a global oncology-focused biopharmaceutical company reported that it is discontinuing its Phase 2 clinical study1 of the investigational Monopolar Spindle 1 (MPS1) inhibitor NMS-153 for the treatment of immune-experienced hepatocellular cancer patients in combination with atezolizumab (Tecentriq).

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The trial confirmed favorable safety profile, but no favorable overall benefit-risk profile. The novel anti-cancer mechanism targeting the mitotic checkpoint showed prior monotherapy activity, likely involving innate immunity, but in this more immune-experienced population the effects seem to be less strong," noted Lisa Mahnke, MD, PhD, Chief Medical Officer of NMS. "The mitotic checkpoint kinase mechanism of NMS-153 is unique, and NMS remains committed to developing novel therapeutics that can address unmet medical needs in cancer," stated Hugues Dolgos, PharmD, CEO of NMS.

With the closure of this Phase 2 trial, NMS has decided to discontinue further development of the NMS-153 program.

Phase II Combination Study of NMS-01940153E and Atezolizumab with or without a prior priming with low dose decitabine for the Treatment of Adult Patients with Unresectable Hepatocellular Carcinoma (HCC) Previously Treated with Immune Checkpoint Inhibitors" (EUCT Number: 2024-516737-12-00)
About NMS-153

NMS-153 is a potent, highly selective small-molecule inhibitor of MPS1 (TTK) with a dual anti-cancer mechanism, inducing mitotic catastrophe and apoptosis while potentially activating anti-tumor immunity via the cGAS/STING pathway. It shows prolonged target engagement and broad in vivo activity as a single agent and in combination therapies. In January 2024, the FDA granted Orphan Drug designation for the treatment of hepatocellular carcinoma (HCC).

About NMS

NMS is a global, integrated biopharmaceutical company focused on the discovery and development of innovative oncology therapies. With affiliates in Nerviano/Corsico (Italy), Boston (USA), and Shanghai (China). NMS leverages deep expertise in drug discovery and translational medicine to advance a pipeline of novel candidates from bench to bedside.

(Press release, Nerviano Medical Sciences, MAR 16, 2026, View Source [SID1234663569])

On March 16, 2026 Kyntra Bio (Nasdaq: KYNB) reported financial results for the fourth quarter and full year 2025 and provided an update on the company’s recent developments.

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"The encouraging results from the investigator-sponsored combination trial of FG-3246 with enzalutamide provide us with valuable insights and reinforce key design elements in our Phase 2 monotherapy study," said Thane Wettig, Chief Executive Officer of Kyntra Bio. "Our Phase 2 monotherapy trial of FG-3246 is progressing as planned, with interim results expected in the second half of 2026. Additionally, we have submitted the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and expect feedback from the FDA shortly, with the intention to start a Phase 3 trial in the second half of 2026. With our successful transformation in 2025, we are well-positioned to execute our strategic plan in 2026 and anticipate an exciting year ahead."

Key Highlights of Fourth Quarter 2025, Recent Developments, and Upcoming Milestones

FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)

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Phase 2 monotherapy trial of FG-3246, a potential first-in-class ADC targeting CD46, in mCRPC is actively enrolling and remains on track for interim analysis in the second half of 2026
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Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC were presented at ASCO (Free ASCO Whitepaper) GU 2026
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FG-3246 and enzalutamide combination therapy, in biomarker unselected patients with androgen receptor pathway inhibitor (ARPI)-treated, taxane-naïve mCRPC, led to a median radiographic progression free survival (rPFS) of 7.0 months in the overall study cohort, with median rPFS of 10.1 months observed in patients who progressed on only one prior ARPI
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Higher tumor uptake of FG-3180 was numerically associated with PSA50 response (nominal p=0.053), highlighting its potential as a biomarker for patient selection
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Combination therapy had a similar safety and exposure profile to the previous FG-3246 Phase 1 monotherapy trial
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Results further validate key FG-3246 Phase 2 monotherapy design elements, most importantly the inclusion of patients who have progressed on only one prior ARPI and integration of baseline FG-3180 PET for all enrolled patients
Roxadustat

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Granted Orphan Drug Designation from the FDA for the treatment of MDS.
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Submitted the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden to the U.S. Food and Drug Administration.
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Company is currently exploring the opportunity to develop roxadustat internally or with a strategic partner, with the goal of starting the Phase 3 trial in the second half of 2026.

Financial

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Total revenue from continuing operations for the fourth quarter of 2025 was $1.3 million, as compared to $3.1 million for the fourth quarter of 2024.
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Total revenue from continuing operations for the full year 2025 was $6.4 million, as compared to $29.6 million for the full year 2024.
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Net loss from continuing operations for the fourth quarter of 2025 was $14.6 million, or $3.61 net loss per basic and diluted share, compared to a net loss of $8.7 million, or $2.15 net loss per basic and diluted share, one year ago.
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Net loss from continuing operations for the full year 2025 was $58.2 million, or $14.40 net loss per basic and diluted share, compared to a net loss of $153.1 million, or $38.26 net loss per basic and diluted share, for the full year 2024.
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As of December 31, 2025, Kyntra Bio reported $109.4 million in cash, cash equivalents, investments, and accounts receivable.
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The Company expects its cash, cash equivalents, investments, and accounts receivable to be sufficient to fund operating plans into 2028.

Conference Call and Webcast Presentation

Kyntra Bio management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on Kyntra Bio’s website.

About FG-3246 and FG-3180

FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by Kyntra Bio for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3180 is a companion diagnostic PET imaging agent, using the same CD46-targeting antibody together with an 89Zr tracker. To date, FG-3180 demonstrated specific uptake in CD46 positive tumors and is currently being evaluated as a biomarker for its potential to inform patient selection.

About Roxadustat

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.

Roxadustat is approved in Europe, Japan, China, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Kyntra Bio has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and Kyntra Bio are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

(Press release, Kyntra Bio, MAR 16, 2026, View Source [SID1234663568])