Olema Oncology Reports First Quarter 2026 Financial and Operating Results

On May 12, 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 first quarter ended March 31, 2026.

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"We continued to meaningfully advance our pipeline of novel therapies focused on transforming the metastatic breast cancer treatment paradigm during the first quarter, with top-line data from our Phase 3 OPERA-01 trial of palazestrant as a monotherapy expected this fall and initial Phase 1 clinical data for OP-3136 being presented at ASCO (Free ASCO Whitepaper) later this month," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We continued patient enrollment in OPERA-02, our Phase 3 trial of palazestrant in combination with ribociclib in the frontline metastatic setting, while advancing our ongoing Phase 1/2 combination studies evaluating palazestrant as a potential combination endocrine therapy of choice for metastatic breast cancer. With important clinical data catalysts on the horizon this year, we believe that we are well-positioned to continue our transformation into a fully integrated oncology company with our first anticipated commercial launch next year."

Recent Progress

Presented two preclinical posters at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April:
The first demonstrated that palazestrant fully recruits the corepressor protein, NCoR1, in vitro, supporting complete estrogen receptor antagonism.
The second reinforced that palazestrant in combination with OP-3136 drives synergistic anti-tumor activity in in vivo estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer models.
Continued enrollment in the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or metastatic breast cancer.
Advanced enrollment in the Phase 1b/2 study evaluating palazestrant in combination with atirmociclib in ER+/HER2- metastatic breast cancer in collaboration with Pfizer.

Anticipated Upcoming Events

Present initial clinical data from the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136 in a poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Present trial-in-progress poster for the ongoing pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer at ASCO (Free ASCO Whitepaper).
Report top-line data from the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer in the fall of 2026.

First Quarter 2026 Financial Results
Cash, cash equivalents, and marketable securities as of March 31, 2026, were $505.3 million.

Net loss for the quarter ended March 31, 2026 was $53.1 million, as compared to $30.4 million for the quarter ended March 31, 2025. The increase in net loss for the first quarter was related to higher spending on clinical development and research and corporate-related activities related to late-stage clinical trials for palazestrant and the advancement of OP-3136.

GAAP research and development (R&D) expenses were $49.2 million for the quarter ended March 31, 2026, as compared to $30.6 million for the quarter ended March 31, 2025. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and increased personnel-related costs, including an increase in non-cash stock-based compensation expense of $3.3 million, mainly due to higher grant prices in 2026 and higher headcount.

Non-GAAP R&D expenses were $42.7 million for the quarter ended March 31, 2026, excluding $6.6 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $27.3 million for the quarter ended March 31, 2025, excluding $3.3 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 G&A expenses were $8.8 million for the quarter ended March 31, 2026, as compared to $4.2 million for the quarter ended March 31, 2025. The increase in G&A expenses was primarily due to higher corporate-related costs, and personnel-related costs, including an increase in non-cash stock-based compensation expense of $2.5 million, mainly due to higher grant prices in 2026.

Non-GAAP G&A expenses were $5.2 million for the quarter ended March 31, 2026, excluding $3.6 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.2 million for the quarter ended March 31, 2025, excluding $1.1 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, MAY 12, 2026, View Source [SID1234665553])

Nurix Therapeutics Announces Bexobrutideg Oral Presentation at the 2026 European Hematology Association Congress

On May 12, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that an abstract highlighting updated efficacy and safety data from the ongoing Phase 1a/b trial of BTK degrader bexobrutideg (NX-5948) in patients with chronic lymphocytic leukemia (CLL) across lines of therapy has been accepted for oral presentation at the 31st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) (EHA2026), taking place June 11-14, 2026, in Stockholm, Sweden.

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Oral Presentation Details:

Title: Updated efficacy and safety data from an ongoing phase 1a/b trial of the BTK degrader bexobrutideg (NX-5948) in patients with CLL across lines of therapy
Presenter: Tahla Munir, MBChB, Ph.D.
Session title: s449 Novel therapies in relapsed/refractory CLL
Session date and time: June 14, 2026, 11:00 – 12:15 CEST
Session Room: A10-11 Hall
Abstract ID: S150

About Bexobrutideg (NX-5948)
Bexobrutideg is an investigational, orally bioavailable, brain penetrant, highly selective small molecule degrader of Bruton’s tyrosine kinase (BTK) currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study of bexobrutideg in patients with relapsed or refractory CLL. Nurix also continues enrollment in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) of bexobrutideg in patients with relapsed or refractory B cell malignancies. Additional information on the ongoing clinical trials can be accessed at clinicaltrials.gov.

(Press release, Nurix Therapeutics, MAY 12, 2026, View Source [SID1234665552])

Nkarta Reports First Quarter 2026 Financial Results and Corporate Highlights

On May 12, 2026 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 first quarter ended March 31, 2026.

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"Putting patients first and providing access to care in a familiar setting close to home matters" said Paul J. Hastings, Chief Executive Officer of Nkarta. "In early April, we reached agreement with the FDA to amend our protocol to allow outpatient dosing in community settings as well as the option to re-dose patients if needed, the removal of overnight monitoring requirements, and the expansion of the Ntrust-2 study to include patients with rheumatoid arthritis. IRB approval of our protocol amendments has been secured across multiple sites, with additional approvals underway. These advancements will enable us to expand patient access beyond urban hubs and major academic centers by engaging community research centers and local rheumatology practices in the neighborhoods where most patients live. We look forward to providing our initial dataset in 2026."

NKX019 Clinical Program Progress and Upcoming Milestones

Enrollment continues across Ntrust-1 and Ntrust-2, our multi-center, open-label, dose-escalation clinical trials evaluating NKX019 in multiple autoimmune diseases.
IRB approval of our protocol amendments has been secured across multiple sites on outpatient dosing, re-dosing, ending overnight monitoring, and adding RA to Ntrust-2.
Patients are being dosed at 4 billion cells per dose x 3 doses (12 billion cells total) across all indications in Ntrust-1 and Ntrust-2.
Initial clinical data from Ntrust-1 and Ntrust-2 are planned for presentation at a medical conference in 2026.

First Quarter 2026 Financial Highlights

Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $266.7 million as of March 31, 2026.
Research and development (R&D) expenses were $25.0 million for the first quarter of 2026. Non-cash stock-based compensation expense included in R&D expense was $0.7 million for the first quarter of 2026.
General and administrative (G&A) expenses were $5.9 million for the first quarter of 2026. Non-cash stock-based compensation expense included in G&A expense was $1.2 million for first quarter of 2026.
Net loss was $27.8 million, or $0.37 per basic and diluted share, for the first quarter of 2026. This net loss includes non-cash charges of $3.4 million that consisted primarily of share-based compensation and depreciation expenses.

Financial Guidance

Nkarta expects its current cash and cash equivalents 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 in patients with autoimmune disease receiving lymphodepletion followed by CD19-targeted CAR-NK cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its potential to achieve durable remission 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 systemic sclerosis, idiopathic inflammatory myopathy, ANCA-associated vasculitis, rheumatoid arthritis, lupus nephritis, and primary membranous nephropathy. Additional participants may be enrolled if needed to refine patient populations for further study.

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 needed, to restore response or enable a deeper response.

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, MAY 12, 2026, View Source [SID1234665551])

Independent Cleveland Clinic Review Finds No Clinically Significant Cardiotoxicity with Moleculin’s Annamycin in R/R AML Patients Dosed Beyond Conventional Anthracycline Limits

On May 12, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported the publication of an abstract at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress highlighting the cardiac safety profile of Annamycin (or as known in scientific journals "L-Annamycin"), the Company’s next-generation anthracycline currently in late-stage development for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML).

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The abstract titled, "Cardiac Safety of L-Annamycin Across High Cumulative Anthracycline Exposure: Implications for Relapsed/Refractory AML," will highlight pooled cardiac safety findings from five completed clinical trials evaluating Annamycin in heavily pretreated patients, including those with substantial prior anthracycline exposure. Importantly, the analysis demonstrated no clinically significant treatment-related cardiotoxicity across cumulative anthracycline-equivalent doses that exceeded conventional lifetime exposure limits associated with traditional anthracyclines.

Anthracyclines remain among the most effective agents in AML treatment, but their clinical utility is constrained by cumulative cardiac toxicity. This limitation is especially relevant in R/R AML, where patients often have prior anthracycline exposure and where currently available salvage therapies following venetoclax-based treatment have demonstrated limited efficacy.

The independent cardiac review, conducted by a cardio-oncology laboratory at the Cleveland Clinic, analyzed comprehensive cardiac monitoring data from 90 patients treated with Annamycin. Among 78 patients with source-data verified pre- and post-treatment ejection fraction assessments, no patients met criteria for clinically significant left ventricular dysfunction. Mean ejection fraction remained stable, and no association was observed between cumulative dose and cardiac function decline. Additional analyses of serial ECGs, troponins, and global longitudinal strain assessments similarly demonstrated no evidence of drug-induced cardiotoxicity.

Management believes these findings reinforce Annamycin’s potential to address a major unmet need in R/R AML by enabling continued anthracycline-based treatment without the cumulative cardiac limitations commonly associated with conventional agents.

"These data further strengthen the clinical rationale for Annamycin as a differentiated anthracycline with the potential to overcome one of the most significant barriers to treatment in AML," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "We believe the combination of encouraging efficacy observed to date and a favorable cardiac safety profile could position Annamycin as an important therapeutic option for heavily pretreated AML patients, including those previously exposed to anthracyclines and venetoclax-based regimens."

The Company believes the results published at EHA (Free EHA Whitepaper) may support broader clinical positioning opportunities for Annamycin in AML and potentially other oncology indications where anthracycline use is currently limited by cardiotoxicity concerns.

(Press release, Moleculin, MAY 12, 2026, View Source [SID1234665550])

Molecular Partners Reports Financial Results and Highlights for Q1 2026, with Clinical Studies Initiated on MP0712 and MP0317

On May 12, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported corporate highlights and unaudited financial results for the first quarter of 2026.

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"Molecular Partners had a strong start to 2026, with two clinical studies initiated. Our lead Radio-DARPin program, MP0712 targeting DLL3, is advancing in a Phase 1/2a trial, with clinical sites open and initial data anticipated this year. In addition, our new data highlight the ability to interchange isotopes on Radio-DARPins, including Lead-212 and Actinium-225, enabling our isotope-agnostic strategy in Radio. It is an exciting time for our company, and we have a strong financial position supporting the development of our growing pipeline of candidates," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

Research & Development Highlights

MP0712 & Radio-DARPin Pipeline

The US multicenter Phase 1/2a study of MP0712 has started (ClinicalTrials.gov: NCT07278479) and is recruiting. Four clinical sites are now open, with a total of nine expected by the end of 2026. Molecular Partners will present trial-in-progress posters on the Phase 1/2a study at the 2026 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and expects to share initial clinical data from this study in 2026.

MP0712 is the Company’s lead Radio-DARPin Therapy (RDT) targeting the tumor-associated protein delta-like ligand 3 (DLL3) and carrying the therapeutic payload 212Pb. MP0712 is being co-developed with Molecular Partners’ strategic partner Orano Med, a pioneer in targeted alpha therapy, for the treatment of patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. The Phase 1/2a study objectives are to assess safety and determine a recommended Phase 2 dose for MP0712. The study contains a pre-treatment imaging and dosimetry step with 203Pb-labeled MP0712.

Molecular Partners and the NuMeRI team of Dr. Mike Sathekge presented first patient imaging and dosimetry data on MP0712 at the 8th Theranostics World Congress (TWC) in January 2026. The data from five evaluable patients with various DLL3-expressing cancers, including SCLC, urothelial, and other neuroendocrine cancers, were generated with MP0712 carrying the diagnostic isotope 203Pb as part of a Named Patient Access Program under the legal framework for compassionate care in South Africa. The dosimetry data and the images, which showed specific uptake as well as robust accumulation of MP0712 in tumor lesions and limited uptake in healthy tissues, as intended, are supportive of the clinical development plans of MP0712 carrying the therapeutic isotope 212Pb.

The Company’s second RDT program MP0726 targets mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer.
Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN – a mechanism which has hampered the development of other MSLN-targeting therapeutics. Molecular Partners intends to advance MP0726 towards first-in-human imaging within the second half of 2026.

Molecular Partners is evaluating tumor targets in an isotope-agnostic manner for its Radio-DARPin pipeline and expects to nominate a new target in the second half of the year.

Molecular Partners presented pre-clinical data at the 3rd Global Radiopharmaceuticals Development Summit (RDS) in March 2026, outlining the suitability of Radio-DARPins to different isotopes. The data showed that the Company’s Radio-DARPin vector design allows interchangeability of alpha isotopes, including 212Pb and 225Ac, enabling an isotope-agnostic strategy to tailor therapeutic candidates to a specific target and disease biology.

In February 2026, the Company announced it entered into a non-exclusive development agreement with Eckert & Ziegler, a global leader in radiopharmaceutical manufacturing. This will expand the potential of Radio-DARPins as vectors for precise delivery of therapeutic alpha-emitting isotopes to tumors, now including 225Ac, in addition to 212Pb through the strategic partnership with Orano Med.

MP0317 (tumor-localized CD40 agonist)

An investigator-initiated, proof-of-concept Phase 2 study of MP0317 combined with standard-of-care (SoC) for the treatment of patients with advanced cholangiocarcinoma has started, with eight sites activated (NCT07036380) and patient treatment ongoing. The study is a randomized, multicenter study in France and aims to recruit 75 patients (with a 2-to-1 design, including 50 patients in the experimental arm and 25 in the control arm). The objective of the study is to assess the clinical benefit of MP0317 combined with SoC comprising the immunotherapy durvalumab, an anti-PD-L1 checkpoint inhibitor, plus gemcitabine-cisplatin-based chemotherapy, compared to SoC alone. MP0317, a FAP-localized CD40 agonist designed to lead to immune-mediated reshaping of the tumor microenvironment (TME), is hypothesized to improve the 12-month progression-free survival rate of patients compared to those treated with SoC only. The TME is known to play a crucial role in the development of cholangiocarcinoma, and of other solid tumor indications, and in treatment resistance.

The Company recently published in Nature Cancer (Steeghs et al. 2026 (e-pub 1 May); DOI: 10.1038/s43018-026-01150-1) the results from the completed Phase 1 dose-escalation study of MP0317 in patients with advanced solid tumors (NCT05098405; 46 patients treated across 9 dose levels). Comprehensive biomarker analyses from this trial confirmed tumor-localized CD40 activation and remodeling of the TME by MP0317, with a favorable safety profile. In addition, MP0317’s pharmacokinetic profile is suited for combination treatment settings, including checkpoint inhibitors. CD40 is an attractive target for cancer immunotherapy due to its strong immune-stimulatory activity. Molecular Partners believes that MP0317’s tumor-localized approach has the potential to deliver superior efficacy with fewer side effects compared to systemic CD40 agonists.

MP0533 (multispecific T cell engager)

MP0533 is being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (NCT05673057), with the dose escalation part fully recruited (10 cohorts). Last patients are on treatment, including two patients in remission for over one year who reached minimal residual disease (MRD) negativity.

Data presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showed an acceptable safety profile for MP0533 monotherapy across all 9 reported treatment cohorts. The pooled data from these 9 cohorts, comprising relapsed/refractory patients, indicate preliminary clinical activity for MP0533 independent of genetic risk profile, in particular in patients with low bone marrow blast count at baseline across different treatment cohorts.

Initial data from cohort 10 are in line with cohorts 1-9 findings and will contribute to defining a recommended dose range for MP0533. The results of this study support the exploration of MP0533 in combination with other AML therapies, and Molecular Partners has been approached by several consortia expressing interest in conducting such studies.

MP0533 is a novel tetra-specific T cell-engaging DARPin designed for selective and broad killing of AML cells in a mutation-agnostic manner. MP0533’s mode of action enables T cell-mediated killing of AML cells – which commonly co-express at least two of the three targeted antigens (CD33, CD123, CD70) – while preserving a therapeutic window that minimizes damage to healthy cells, which normally express one or none of the targets.

MP0632 and Switch-DARPin Platform (logic-gated immune cell engagers)

Molecular Partners presented new pre-clinical data on its Switch-DARPin T cell engager, with MP0632 announced as lead, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026. These data support proof-of-concept of the Switch-DARPin design, showing that MP0632 leads to regression of established tumors expressing both EpCAM and MSLN, with minimal impact on tumors expressing only one of the antigens, thereby indicating a favorable therapeutic window. In addition, MP0632 allowed for safe use of potent CD2 co-stimulation for efficient tumor cell killing with low cytokine release profile. The data support MP0632’s potential as clinical lead candidate for the treatment of solid cancers expressing MSLN and EpCAM, including ovarian, endometrial, pancreatic, and other cancers.

MP0632 is a logic-gated Switch-DARPin T-cell engager (TCE), designed to achieve conditional tumor-localized immune activation targeting MSLN and EpCAM, which are highly co-expressed in ovarian cancer and other solid tumors. The CD3-engaging DARPin is unmasked ("Switched" on) and activates T cells only upon binding to both MSLN and EpCAM. MP0632 is half-life extended through a Fc domain, which broadens the Company’s capabilities in half-life engineering modalities.

Corporate Governance Highlights

All motions proposed by the Board of Directors at the Annual General Meeting, held in April, were approved by the shareholders of the Company by a wide majority.

This included the election of Clare Fisher by shareholders to the Board of Directors. Clare Fisher has more than two decades of healthcare experience in leadership roles, including corporate and business development, mergers and acquisitions, and strategy. She is currently the SVP for Global Business Development and M&A at BeOne Medicines, a global oncology company committed to discovering and developing innovative treatments for cancer patients worldwide.

Financial and Business Outlook

The Company’s cash and cash equivalents and short-term time deposits were CHF 79 million (approximately USD 100 million) as of March 31, 2026, which, based on current operating assumptions, will be sufficient to fund its operations and capital requirements into late 2027 (previously early 2028) with increased R&D investment in an expanding pipeline.

Financial Calendar

August 25, 2026
Half-year results 2026
October 29, 2026
Interim Management Statement Q3 2026 (unaudited)

The latest timing of the above events can be viewed on the investor section of the website.

(Press release, Molecular Partners, MAY 12, 2026, View Source [SID1234665549])