On May 26, 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 a clinical trial collaboration and supply agreement with Bayer AG ("Bayer") to evaluate OP-3136, Olema’s investigational lysine acetyltransferase 6 (KAT6) inhibitor, in combination with NUBEQA (darolutamide), Bayer’s androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1b/2 study is designed to assess the safety, tolerability, and preliminary anti-tumor activity of OP-3136 in combination with darolutamide in approximately 36 patients with mCRPC.

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"We are very pleased to partner with Bayer to explore the combination of OP-3136 with darolutamide in metastatic castration-resistant prostate cancer, which is an aggressive disease characterized by poor clinical outcomes," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "This agreement represents the first clinical collaboration for OP-3136 and builds upon our ongoing Phase 1/2 study of this novel KAT6 inhibitor as a monotherapy in multiple solid tumor types and in combination with fulvestrant and palazestrant in ER+/HER2- metastatic breast cancer. We look forward to advancing OP-3136 in combination with darolutamide in the clinic as we work to bring better medicines to patients living with cancer."

Under the terms of the agreement, Bayer will supply darolutamide for use in the Phase 1b/2 study and Olema will lead the conduct of the study. All clinical data and inventions related to the combined use of OP-3136 and darolutamide will be jointly owned. Olema will maintain full global commercial and marketing rights to OP-3136.

As previously announced, Olema will present initial clinical data from the Phase 1 study of OP-3136 in a poster presentation on May 30, 2026 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois.

(Press release, Olema Oncology, MAY 26, 2026, View Source [SID1234666057])

On May 26, 2026 Moleculin presented its corporate presentation.

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(Press release, Moleculin, MAY 26, 2026, View Source [SID1234666056])

On May 26, 2026 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported a business update and announced its cash position as of March 31, 2026.

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"During the first quarter of 2026, we continued to execute with financial discipline while supporting the advancement of our clinical and regulatory priorities. The drawdown of EIB Tranche B, combined with ongoing operational optimization, has extended our cash runway into November 2026 supporting the upcoming regulatory steps, including the planned re-examination of the Marketing Authorization Application for MaaT013 (Xervyteg)," stated Eric Soyer, CFO of MaaT Pharma.

Pipeline highlights

In Hemato-Oncology

Acute Graft-versus-Host Disease (aGvHD) – MaaT013 (Xervyteg)

In January 2026, MaaT Pharma transitioned the Early Access Program in Europe to Clinigen, allowing MaaT Pharma to leverage the infrastructure of Clinigen and start expanding patient access. The Company has treated approximately 230+ patients under the Early Access Program in 13 different countries to date, and data from the EAP has been presented at major medical congresses.
In March 2026, during the EBMT 2026 annual congress:
The final results of the ARES pivotal trial evaluating MaaT013 (Xervyteg) in aGvHD were presented during an oral presentation during the presidential symposium at EBMT 2026 Annual Congress on March 23, 2026.
MaaT Pharma‘s strategic partner Clinigen hosted a dedicated Industry Symposium on advancing care for steroid-refractory gastrointestinal aGvHD, in the context of the transition in January 2026 of the EAP program to Clinigen, and the ongoing commercial readiness activities, subject to the marketing approval of MaaT013 (Xervyteg).
The Company also presented results from the CHRONOS study, one of the largest real-world studies including refractory GI-aGvHD patients (n=59) treated with third-line best available treatments other than microbiome-based therapy, and announced publication in April 2026 of those retrospective data in Bone Marrow Transplantation Journal. Results from CHRONOS included 29% 12-month overall survival and 37% Day-28 GI-overall response rate, thus supporting the urgent need for new therapeutic options in this indication.
MaaT013 (Xervyteg) Regulatory Plan:
As a post period event, MaaT Pharma announced in May 2026 that during the Oral Explanation with EMA’s CHMP, the Company was informed of a "negative trend" in relation with the upcoming June 2026 CHMP vote. Subject to the formal vote at the June 2026 CHMP meeting, the Company intends to request a re-examination of the application.
As previously announced, the U.S. development plan remains underway, with no material cash impact, to ensure a potential launch in a timely manner of the future clinical study in the U.S, subject to appropriate funding and regulatory, clinical, and operational readiness.
Additionally, the Company continues to expand its U.S. footprint through its EAP, with recurring patient requests from leading hospitals such as City of Hope (Duarte- Los Angeles, CA), Massachusetts General Hospital (Boston, MA), the University of Alabama Hospital (Birmingham, AL), Miami Cancer Institute (Miami, FL), Chicago Medical Center (Chicago, IL) and Advocate Lutheran Hospital (Park Ridge, IL).

Allogenic Hematopoietic Stem Cell Transplant (allo-HSCT) – MaaT033

In January 2026, as a post period event, a third routine evaluation was conducted and reconfirmed the favorable safety profile of MaaT033 in this trial. The Phase 2 PHOEBUS trial is ongoing and is potentially pivotal in Europe. Topline results (1-year overall survival) are expected in Q4 2028.
In March 2026, the Company presented a poster of the PHOEBUS Phase 2 trial during the EBMT 2026 annual congress, detailing the design and the favorable safety profile confirmed by the 5 DSMBs assessments since 2025.

In Immuno-Oncology

MaaT034 – Next-generation drug candidates with co-cultured technology

In 2026, the Company is focusing on GMP batch production and regulatory readiness and targets to initiate a First-in- Human trial in 2027, subject to appropriate funding, with a development strategy that will place a particular focus on the U.S. market.
In January 2026, MaaT Pharma announced that the first patient was randomized in the IMMUNOLIFE trial evaluating the potential of MaaT033 in combination with Regeneron’s Cemiplimab in enhancing disease control rate versus best investigator’s choice in patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance to PD-1/PD-L1 blockade following antibiotic (ATB) exposure and who present ATB-induced gut dysbiosis. The Company was also informed by PICASSO’s academic sponsor that topline results could be expected in H1 2026. However, the timing remains subject to the sponsor’s discretion and the Company has no control over the study results communication timelines. The PICASSO expected data are intended to provide complementary insights only and do not directly impact MaaT034’s development strategy.

Cash position[1]

As of March 31, 2026, total cash and cash equivalents were EUR 18.1 million (as compared to EUR 24.9 million as of December 31, 2025), not including the drawdown in April 2026 of Tranche B (EUR 6 million) of the European Investment Bank (EIB) loan financing.
The Company has taken cash management measures to extend its financial visibility into November 2026 (vs August 2026), covering the upcoming regulatory milestones including the re-examination process, while continuing to advance its pipeline.

Revenues in Q1 20261

MaaT Pharma reported revenues of EUR 0.8 million for the first quarter of 2026 (reported EAP revenues were EUR 1.1 million for the same period of 2025).
Since January 2026 and the transition to the EAP program to Clinigen, MaaT Pharma is now selling the product to Clinigen, which then supplies hospitals in Europe. As a result, revenues generated by the Company are now based on the financial terms of the licensing agreement. Consequently, the net income reported by MaaT Pharma in Q1 2026, based on transfer price and royalties, was EUR 0.8 million, and would have been EUR 1.3 million pre-transition.
The slight decrease in reported revenues was therefore mostly attributable to the change in revenue accounting. On a same like-for-like basis, revenues generated by MaaT013 (Xervyteg) in Q1 2026 reflected a 19% increase year-over-year, underlining the sustained demand for the product.

Financial calendar*

June 16, 2026: Annual General Meeting
September 29, 2026: Publication of H1 2026 results
November 16, 2026: Publication of revenues & cash for Q3 2026
*Indicative calendar that may be subject to change.

Availability of the Documents Preparatory to the Annual General Meeting

The Company’s shareholders are invited to attend the Combined General Meeting to be held on Tuesday, June 16, 2026, at 9:30 a.m. at the Company’s offices, 70 avenue Tony Garnier – 69007 Lyon, France.
The preliminary notice of meeting, including the agenda and draft resolutions, was published in the Bulletin des Annonces Légales et Obligatoires (BALO) No. 56 dated May 11, 2026, and the notice of meeting will be published in the legal gazette "Le Tout Lyon" on May 27, 2026.
As of today, all information and documents referred to in Articles R. 22-10-23, R. 225-81 and R. 225-83 of the French Commercial Code are available on the Company’s website: maatpharma.com
In accordance with Articles L. 225-115 and R. 225-83 of the French Commercial Code, the full text of the documents to be presented at the General Meeting will also be made available at the Company’s registered office.
The General Meeting will be broadcast live in full by video, and the connection details will be available on the Company’s website. A replay will be made available no later than seven business days after the General Meeting has been held.

Upcoming conferences participation*

June 24-25, 2026 – Portzamparc Conference Mid & Small Caps 2026, Paris

(Press release, MaaT Pharma, MAY 26, 2026, View Source [SID1234666055])

On May 26, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, reported compelling first-in-human data from the FIT-001 clinical trial of its next-generation farnesyl transferase inhibitor (FTI) darlifarnib in combination with adagrasib in heavily pretreated patients with KRAS G12C-mutated advanced solid tumors. The results will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 30, 2026.

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The combination of darlifarnib plus adagrasib demonstrated meaningful antitumor activity in heavily pretreated pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) patients with prior KRAS inhibitor (KRASi) exposure, as well as KRASi-naïve colorectal cancer (CRC) patients. These data provide clinical proof-of-mechanism for Kura’s FTI platform as a precision combination that blocks RHEB-dependent mTORC1 signaling, a key resistance pathway shared across multiple targeted therapy classes.

"These results are very encouraging for patients and represent a major milestone for the FTI field," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Darlifarnib delivered robust tumor shrinkage and high objective response rates across KRAS G12C-mutated PDAC, NSCLC and CRC. These data compare favorably to adagrasib monotherapy benchmarks and demonstrate consistent, meaningful clinical activity in three difficult-to-treat tumor types. This marks "three-for-three" for targeting the mTORC1-RHEB pathway using an FTI approach to overcome resistance to targeted therapies, building on prior positive combinations with VEGFR tyrosine kinase inhibitors and PI3Kα inhibitors, and now KRAS inhibitors. With compelling clinical activity across multiple tumor types and a manageable safety profile, darlifarnib is well-positioned as a preferred combination partner for KRAS inhibitors and other precision therapies."

"RAS inhibitors have raised the bar in the treatment of KRAS-mutated cancers, but resistance remains a major limitation of current therapies," said David S. Hong, M.D., Deputy Chair of the Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center. "This approach targeting a key downstream resistance node is exciting, and the early activity and tolerability of darlifarnib plus adagrasib support further development of this combination to deepen and extend responses."

Key Highlights (Phase 1a, N=30; 26 response evaluable):

77% (20/26) of response-evaluable patients achieved tumor shrinkage, including 94% (15/16) of response-evaluable, KRASi-naïve patients
Objective response rate (ORR): 67% in PDAC, 50% in NSCLC, and 29% in KRASi-naïve CRC
Responses were observed across dose levels and tumor types
Clinical activity observed in heavily pre-treated patients, including those with prior KRASi exposure
In NSCLC, confirmed partial response and 84% target lesion reduction observed in a patient previously treated with a KRAS inhibitor
Median follow-up time (range): PDAC 6.7 (4.0-10.4) months; NSCLC 6.9 (3.2-11.8) months; CRC 8.9 (1.2-13.2) months
37% of patients remained on study treatment at time of data cutoff (March 25, 2026)
Combination was well tolerated with a manageable safety profile
Best Percent Change in Target Lesion Size: PDAC, NSCLC and CRC

Best Percent Change in Target Lesion Size: PDAC, NSCLC and CRC

The waterfall plot shows best percent change from baseline in target lesion size among response-evaluable patients. Objective responses were observed across all three tumor types and dose levels. Bars that extend below the -30% horizontal line indicate target lesion reductions meeting the RECIST threshold for response, and all PRs represent confirmed partial responses.

Darlifarnib is designed to address resistance across multiple targeted therapies by inhibiting RHEB farnesylation, resulting in a sustained blockade of mTORC1 signaling and enhancing anti-tumor activity of RAS inhibitors. In pre-clinical models, darlifarnib enhances anti-tumor activity of RAS inhibitors in NSCLC and CRC.

Patients were administered darlifarnib 3 mg, 5 mg, or 8 mg once daily on days 1-7 and 15-21 of each 28-day cycle in combination with adagrasib 400 mg twice daily. The darlifarnib 8 mg dose will not be advanced for further evaluation in the darlifarnib and adagrasib combination.

The full ASCO (Free ASCO Whitepaper) presentation will be available starting May 30, 2026, at 5:00 a.m. PT / 8:00 a.m. ET on Kura’s website at www.kuraoncology.com under the Posters and Presentations tab in the Farnesyl Transferase Inhibition section.

Virtual Investor Event
Kura will host a webcast and conference call on June 3, 2026, at 12:15 p.m. PT / 3:15 p.m. ET featuring management and David S. Hong, M.D., Deputy Chair of the Department of Investigational Cancer Therapeutics, The University of Texas M.D. Anderson Cancer Center. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

About the FIT-001 Trial
FIT-001 (NCT06026410) is a Phase 1 clinical trial evaluating darlifarnib (KO-2806) as a monotherapy and in combination with targeted therapies in patients with advanced solid tumors. The trial includes an escalation cohort of patients with RAS-altered advanced solid tumors, as well as dose escalation and dose optimization cohorts evaluating darlifarnib with cabozantinib in advanced renal cell carcinoma, and with adagrasib in KRAS G12C-mutant advanced PDAC, NSCLC, and CRC.

(Press release, Kura Oncology, MAY 26, 2026, View Source [SID1234666054])

On May 26, 2026 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), a clinical-stage oncology company advancing therapies designed to reprogram cancer biology and overcome treatment resistance, reported plans to expand its ongoing Phase 1b clinical trial evaluating lead asset paxalisib in combination with standard-of-care therapies in patients with advanced triple negative breast cancer ("TNBC"). Based on continued encouraging safety, tolerability and clinical activity data observed to date, planned enrollment has increased from 12 to 36 patients.

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The expansion is intended to further evaluate the safety, tolerability, dose optimization and preliminary efficacy of the paxalisib-based combination regimen with pembrolizumab and chemotherapy. The expanded dataset is expected to provide a more meaningful assessment of objective response rate ("ORR"), progression-free survival ("PFS") and translational biomarkers. Additional clinical trial updates are anticipated throughout 2026 and into 2027.

"We remain encouraged by the safety and tolerability data observed to date, and expanding enrollment allows us to generate a broader clinical and translational dataset as we advance paxalisib in difficult-to-treat advanced breast cancer, such as TNBC," said Dr. John Friend, CEO, Kazia Therapeutics. "Paxalisib’s mechanism, modulating key resistance and immune-related pathways, addresses the very reasons that current therapies fail, and we believe it holds meaningful potential for an underserved patient population. While we planned to present scientific progress at ASCO (Free ASCO Whitepaper) 2026, we made the decision to withdraw our abstracts solely to protect our intellectual property position ahead of anticipated filings. The withdrawal was not related to any safety or clinical concerns. We expect to share additional clinical and translational updates in the coming months."

The Phase 1b study is evaluating paxalisib in combination with established breast cancer regimens across multiple dose cohorts. The trial expansion is supported by a recently published preclinical study in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR"), demonstrating that dual PI3K/mTOR inhibition with paxalisib altered tumor cell state and immune signaling in preclinical TNBC models. TNBC accounts for approximately 15 to 20 percent of all breast cancer diagnoses and is associated with poorer outcomes relative to other breast cancer subtypes.

(Press release, Kazia Therapeutics, MAY 26, 2026, View Source [SID1234666053])