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OPKO Health’s ModeX Therapeutics Will Present Data Demonstrating In Vivo CAR-T Cell Generation and Deep B-Cell Depletion in Preclinical Studies

On May 12, 2026 ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), reported preclinical data demonstrating the in vivo generation of CAR-T cells and deep systemic B-cell depletion achieved with its MDX3001 candidate in animal models. The data, generated using ModeX’s CD3xCD28 antibody-conjugated lipid nanoparticle (LNP)/mRNA platform, will be presented at the ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting, being held May 11-15 in Boston.

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The abstract, titled "Bispecific CD3xCD28 Antibody-LNPs Drive In Vivo CAR-T Cell Generation with Deep B-Cell Depletion," highlights preclinical studies showing B-cell depletion in blood and lymphoid tissues, including spleen, bone marrow, and lymph nodes. Activity was confirmed in both humanized mouse and non-human primate models.

By combining CD3 with CD28 costimulatory engagement, the technology enables efficient T-cell transfection, activation, and functional CAR-T cell generation directly in vivo. The antibody-conjugated LNP directs cell-specific gene delivery, and the mRNA nature of the platform, obviates the need for pre-conditioning chemotherapy while allowing for repeat dosing, leading to expansion and persistence of functional memory T-cell populations.

"These data demonstrate the strength of our in vivo targeting technology," said John Mascola, M.D., Chief Scientific Officer of ModeX Therapeutics. "Our antibody-conjugated LNP platform offers a simple and versatile approach to gene delivery for immune cells in vivo, and has the potential to simplify treatment access by eliminating the burden of ex vivo manufacturing."

"Our targeted gene delivery platform uses proprietary ModeX technology to generate CAR-T cells directly in patients," said Gary Nabel, M.D., Ph.D., President and Chief Executive Officer of ModeX Therapeutics. "It offers a promising clinical modality for diverse diseases, including autoimmunity and oncology."

Oral Presentation Details

Title: Bispecific CD3xCD28 Antibody-LNPs Drive In Vivo CAR-T Cell Generation with Deep B Cell Depletion
Abstract Number: 338
Meeting: ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting
Date/Time: May 14, 2026 at 10:15 a.m. Eastern time
Location: Thomas M. Menino Convention Center, Boston

(Press release, Opko Health, MAY 12, 2026, View Source [SID1234665554])

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.

"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.

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.

"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).

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])