On May 15, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported financial results for the first quarter ended March 31, 2026 and provided a corporate update.

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"With enrollment now surpassing the first interim analysis threshold in the MIRACLE trial, we are just weeks away from beginning what we believe will be the most transformative period in the Company’s history. The impressive preliminary blinded remission data trend we reported earlier this year continues with the 45 subject blinded data. This trend supports our belief in Annamycin’s potential to meaningfully improve outcomes for patients with relapsed or refractory AML," said Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

"We also believe Annamycin has the potential to redefine the anthracycline class by addressing one of the most significant limitations of these foundational therapies, cardiotoxicity, while potentially expanding access to treatment options for patients who otherwise may not be eligible for standard anthracycline-based therapy due to current life-time dose limits," Mr. Klemp added.

Recent Highlights

Achieved enrollment of the first 45 subjects in the pivotal MIRACLE Phase 2B/3 trial evaluating Annamycin in combination with cytarabine ("AnnAraC") for the treatment of relapsed/refractory acute myeloid leukemia (AML)
Continued to observe encouraging blinded efficacy trends in the MIRACLE trial, including a previously reported preliminary blinded composite complete remission (CRc) rate of 40% at the first 30 subjects treated mark and also at the 45th subject mark
Completed financing transactions during the first quarter of 2026 resulting in approximately $8.3 million in gross proceeds, strengthening the Company’s near-term operating runway
Continued expansion of clinical trial operations across the United States and Europe to support accelerated enrollment and future development activities
Bolstered global intellectual property strategy for Annamycin, now covering four continents
Clinical Development Update

Annamycin – MIRACLE Trial
Moleculin continues to advance the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) trial, a pivotal adaptive-design Phase 3 study evaluating AnnAraC in adult patients with relapsed or refractory AML.

Expected Milestones for Annamycin Development Program

Q2 2026: MIRACLE – Unblinding of data for 45 subjects
Q3 2026: MIRACLE – Part A 90 subjects recruited and unblinding thereafter
2H 2026: MIRACLE – Start of Part B
2H 2026: Atlantic Health pancreatic cancer clinical trial begins
2027: Begin recruitment of 3rd line AML subjects
2027: Begin pediatric AML clinical study
2028: End recruitment of Part B
2028: Primary efficacy data for MIRACLE 2nd line subjects
2028: Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE
Additional Pipeline Programs

Moleculin continues to support externally funded and investigator-sponsored studies involving WP1066 and other pipeline candidates targeting difficult-to-treat cancers and viral diseases.

First Quarter 2026 Financial Results

Research and development expenses for the three months ended March 31, 2026 and 2025 were $5.4 million and $3.4 million, respectively. The increase of $2.0 million is mainly related to the MIRACLE clinical trials in Europe of $1.4 million, additional nonclinical studies of $0.3 million and other research costs during the current quarter as compared to the prior year quarter.

General and administrative expenses for the quarter ended March 31, 2026 were approximately $2.5 million, compared with $2.5 million for the same period in 2025.

As of March 31, 2026, the Company had cash and cash equivalents of approximately $10.3 million. Management believes current cash resources, together with recent financing proceeds, will support planned operations into the third quarter of 2026.

(Press release, Moleculin, MAY 15, 2026, View Source [SID1234665773])

On May 15, 2026 MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company developing allogeneic invariant natural killer T (allo-iNKT) cell therapies to restore immune balance and treat immune-mediated diseases and cancer, reported financial results for the first quarter ending March 31, 2026, and provided a corporate update.

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"MiNK entered 2026 focused on converting a growing body of clinical and translational evidence into prospective validation," said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. "During the first quarter and subsequent period, we advanced agenT-797 into a randomized Phase 2 study in acute lung injury and critical illness, presented data that further support the context-dependent biology of iNKT cells, and continued to expand the platform through selective, non-dilutive collaborations. This is the next phase of MiNK’s strategy: disciplined clinical execution, rigorous translational validation, and capital-efficient expansion of a broadly deployable cell therapy platform."

Dr. Buell continued, "What continues to distinguish agenT-797 is both its biology and its practicality. As an off-the-shelf iNKT cell therapy administered without lymphodepletion or HLA matching, agenT-797 is designed for settings where immune dysfunction drives poor outcomes and where speed, tolerability and deployability matter. We believe this is particularly relevant in severe acute lung injury and critical illness, where patients often face a cascade of respiratory failure, secondary infection and organ dysfunction with limited therapeutic options."

Recent Business and Development Highlights

agenT-797 Advanced into Randomized Phase 2 Clinical Evaluation in Acute Lung Injury and Critical Illness

MiNK initiated a randomized Phase 2 clinical trial evaluating agenT-797 plus standard of care compared with placebo plus standard of care in adults with severe acute lung injury and critical illness, including moderate to severe acute hypoxemic respiratory failure due to severe pneumonia, who meet Global ARDS criteria and are admitted to the ICU. The study is being designed with a seamless Phase 2/3 operational framework intended to support efficient transition into later-stage development if findings from the randomized Phase 2 portion are prospectively confirmed.

The trial has received authorization from the Ukraine Ministry of Health, is supported by an active U.S. IND, and remains subject to FDA clearance for planned U.S. site activation. Preliminary data are expected in the second half of 2026.

Acute lung injury and ARDS remain among the most serious unresolved conditions in critical care. ARDS affects an estimated 3 million patients globally and approximately 200,000 patients annually in the United States, accounting for nearly 25% of mechanically ventilated ICU patients.i Mortality remains high, approximately 40% to 50%, and there are currently no approved pharmacologic therapies shown to reduce mortality in ARDS.ii The trial is designed to prospectively evaluate agenT-797 in a clearly defined, critical care population where ventilator-free days, secondary infection, respiratory recovery and survival can be assessed within clinically meaningful and regulatory-aligned endpoints.

Recent Data at AACR (Free AACR Whitepaper) and ASGCT (Free ASGCT Whitepaper) Strengthen the Biologic Rationale for Context-Dependent iNKT Activity

Recent clinical and translational presentations at the American Association for Clinical Research (AACR) (Free AACR Whitepaper) Annual Meeting and the American Society of Gene and Cell Therapy Meeting (ASGCT) (Free ASGCT Whitepaper) reinforced the potential of MiNK’s iNKT platform to generate disease-relevant immune activity across distinct clinical settings.

In PD-1 refractory gastroesophageal cancer, investigator-sponsored Phase 2 data showed disease control and longer-term survival in a subset of heavily pretreated patients, supported by evidence of immune activation and tumor microenvironment remodeling. The study achieved a 77% disease control rate, with long-term survival beyond 20 months observed in a subset of patients with immune-induction prior to chemotherapy. These patients also had longer progression-free survival compared with those treated without induction, with median PFS of 6.9 months versus 3.5 months.

At ASGCT (Free ASGCT Whitepaper), translational analyses showed that the same off-the-shelf agenT-797 product generated distinct immune outputs in solid tumor and ARDS patients. In solid tumor patients, agenT-797 was associated with a TH1 pro-inflammatory signature consistent with anti-tumor immune activation. In ARDS patients, the same product was associated with a TH2 anti-inflammatory signature consistent with immune restoration and lung injury recovery.

Together, these findings support MiNK’s broader development strategy: advancing agenT-797 in settings where immune dysfunction contributes to poor outcomes, while using translational data to define patient populations, biologic mechanisms and future development pathways.

Non-Dilutive Collaborations Support Capital-Efficient Platform Expansion

MiNK continued to advance its strategy of expanding the iNKT platform through selective collaborations that provide external support and potential downstream economics while preserving focus on lead clinical programs.

In the first quarter, MiNK announced a collaboration with C-Further, an international pediatric oncology therapeutics consortium enabled by Cancer Research Horizons, LifeArc and Great Ormond Street Hospital Charity, to advance a PRAME-targeted TCR-engineered iNKT cell therapy for pediatric cancers. The collaboration provides up to approximately $1.1 million in non-dilutive aggregate funding to support IND-enabling development, with potential meaningful double-digit downstream commercial revenue participation.

The C-Further program applies MiNK’s off-the-shelf iNKT platform to a validated tumor antigen strategy in pediatric oncology and reflects the company’s broader approach to platform expansion through externally supported, capital-efficient development.

MiNK is also advancing additional externally supported programs, including its graft-versus-host disease program supported by NIH STTR funding and the Mary Gooze philanthropic award. These collaborations and funding sources are intended to support pipeline progress while reducing the capital burden typically associated with multi-program cell therapy development.

Upcoming ATS Presentation Extends Platform Discussion into Persistent Pulmonary Infection and Immune Dysfunction

MiNK will present clinical data featuring agenT-797 at the American Thoracic Society (ATS) International Conference 2026. The presentation, titled "Novel Interleukin-15 Superagonist (N-803) and Invariant Natural Killer T Cell (agenT-797) Combination Immunotherapy for Unresolving Coccidioides immitis Infection," will be presented by Terese Hammond, M.D., and in collaboration with ImmunityBio (NASDAQ: IBRX) on May 20, 2026.

In accordance with ATS guidelines, no data or results have been disclosed prior to the conference. The presentation is expected to expand the platform discussion beyond oncology and acute inflammatory lung injury into persistent infection, immune dysfunction and pathogen control, areas where MiNK believes immune restoration may have broader therapeutic relevance.

Financial Results

MiNK ended the first quarter of 2026 with approximately $9.5 million in cash and cash equivalents, compared with approximately $13.4 million as of December 31, 2025. During the quarter, the company completed repayment of approximately $5.2 million associated with the Agenus convertible note, further simplifying its balance sheet. Following this repayment, MiNK raised approximately $3.0 million through its at-the-market sales agreement during the three months ended March 31, 2026.

Net loss for the first quarter of 2026 was approximately $2.7 million, or $0.57 per share, compared with approximately $2.8 million, or $0.70 per share, for the same period in 2025.

(Press release, MiNK Therapeutics, MAY 15, 2026, View Source [SID1234665772])

On May 15, 2026 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a biotechnology company focused on identifying and advancing innovative therapeutics, reported its first quarter 2026 financial results and provided a corporate update.

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Recent Highlights

Instil is evaluating potential acquisitions and in-licensing that may provide access to promising novel therapeutic candidates
Cash position of approximately $74.7 million as of March 31, 2026 expected to fund current operating plan beyond 2027
"We continue to make progress refining Instil’s strategy and positioning the company for its next phase of growth," said Bronson Crouch, Chief Executive Officer, Instil Bio. "We are actively evaluating a range of acquisition and in-licensing opportunities, with a focus on assets that align with our capabilities and offer the potential to create long-term value. With a strong balance sheet, we are well positioned to act with discipline and flexibility as we work to build a focused, high-quality pipeline and advance new treatment options for patients."

There can be no assurance that any transaction will result from these efforts, nor as to the timing of any such outcome. Instil does not intend to provide further updates unless and until a specific transaction is approved or disclosure is otherwise deemed appropriate.

First Quarter 2026 Financial and Operating Results:

As of March 31, 2026, Instil had approximately $74.7 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $5.0 million in cash and cash equivalents, $0.1 million in restricted cash and $69.5 million in marketable securities, compared to $76.3 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $6.6 million in cash and cash equivalents, $0.2 million in restricted cash, and $69.5 million in marketable securities, as of December 31, 2025. Instil expects that its cash, cash equivalents, restricted cash and marketable securities as of March 31, 2026 will enable it to fund its current operating plan beyond 2027.

Research and development expenses were $0.7 million for the three months ended March 31, 2026, compared to $5.4 million for the three months ended March 31, 2025.

General and administrative expenses were $5.3 million for the three months ended March 31, 2026, compared to $9.1 million for the three months ended March 31, 2025.

Restructuring and impairment charges were $1.0 million for the three months ended March 31, 2026, compared to $16.1 million for the three months ended March 31, 2025.

Net loss per share, basic and diluted was $0.62 for the three months ended March 31, 2026, compared to $4.32 for the three months ended March 31, 2025. Non-GAAP net loss per share, basic and diluted was $0.32 for the three months ended March 31, 2026, compared to $1.32 for the three months ended March 31, 2025.

(Press release, Instil Bio, MAY 15, 2026, View Source [SID1234665771])

On May 15, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported financial results for the first quarter ended March 31, 2026, and provided business updates.

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"We are excited that new survival data from 55 first-line pancreatic cancer patients treated with atebimetinib + mGnP in our Phase 2a clinical trial will be reported in an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting on June 1st," said Ben Zeskind, Chief Executive Officer of Immuneering. "We believe the upcoming presentation at ASCO (Free ASCO Whitepaper) is an excellent opportunity to build on the recent momentum in second-line pancreatic cancer and demonstrate atebimetinib’s potential to provide a differentiated first-line option for patients. Our Phase 3 study of atebimetinib + mGnP in first-line pancreatic cancer patients, MAPKeeper 301, is now recruiting patients, and we remain on track to dose the first patient by mid-2026. Our Phase 2 lung cancer trial is on track to dose the first patient in the second half of the year. I believe we are entering a new era in cancer care where treatments have the potential to drive longer survival with fewer harsh side effects, and that atebimetinib will play an important role in that future."

Recent Corporate Highlights

Upcoming oral presentation at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: On June 1, 2026, Dr. Peter Vu, MD, MHA, UC San Diego Health, will present new survival data from an expanded cohort totaling 55 first-line pancreatic cancer patients treated with atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in Immuneering’s Phase 2a clinical trial. The oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting utilizes a data cutoff in April 2026.

Pivotal Phase 3 MAPKeeper 301 trial now recruiting: The global randomized Phase 3 trial of atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) versus modified gemcitabine/nab-paclitaxel alone in first-line metastatic pancreatic cancer (NCT07562152) is now recruiting patients across multiple clinical sites. The company remains on track to dose the first patient by mid-2026.

New genetic data from atebimetinib-treated patients demonstrating the mechanism’s potential to improve durability and survival: At the 2026 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 20, 2026, Immuneering presented new genetic data in a poster presentation demonstrating a key mechanism that may improve durability and survival, supporting the use of atebimetinib as a first-line treatment in pancreatic cancer and beyond. The circulating tumor DNA (ctDNA) data from 123 atebimetinib-treated patients showed that acquired MAPK pathway alterations were rarely seen. These findings suggest that Deep Cyclic Inhibitors have the potential to overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients, while potentially preserving sensitivity to subsequent treatments.

27 months progression free survival to date in a third-line pancreatic cancer patient treated with atebimetinib monotherapy: The company provided an update on a third-line pancreatic cancer patient, with over 18 centimeters of tumors at baseline, who began receiving atebimetinib monotherapy 27 months ago. The patient continues on treatment, with an 85% reduction in tumor burden as of the most recent scan, with complete resolution of four lesions: a bone lesion, two liver lesions, and a non-target pancreatic lesion. The patient has gained 23 pounds over the course of treatment and reported improved quality of life with no grade 3 adverse events. A detailed description of the case is planned for submission to a medical journal.
Anticipated Near-Term Milestones

Immuneering remains on track to achieve several near-term anticipated milestones related to atebimetinib, including:

Q2 2026: Report updated survival data from an expanded cohort totaling 55 first-line pancreatic cancer patients treated with atebimetinib + mGnP at the 2026 ASCO (Free ASCO Whitepaper) annual meeting.
Mid-2026: Dose the first patient in pivotal Phase 3 MAPKeeper 301 clinical trial of atebimetinib + mGnP in first-line pancreatic cancer.
2H 2026: Dose the first patient in trial of atebimetinib + Libtayo in RAS-mutant first-line non-small cell lung cancer.
First Quarter 2026 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 were $198.6 million, compared with $217.0 million as of December 31, 2025.

Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $10.6 million, compared with $11.5 million for the first quarter of 2025. The decrease in R&D expenses was primarily attributable to decreases in clinical spend related to the envometinib (IMM-6-415) program, partially offset by increased clinical costs related to the Company’s lead atebimetinib program and spend related to other preclinical programs.

General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 were $4.7 million, compared with $4.0 million for the first quarter of 2025. The increase in G&A expenses was primarily attributable to employee related costs and increased professional fees in connection with the general and administrative functions supporting the Company’s business.

Net Loss: Net loss attributable to common stockholders was $13.5 million, or $0.21 per share, for the first quarter ended March 31, 2026, compared to $15.0 million, or $0.42 per share, for the first quarter ended March 31, 2025. 

2026 Financial Guidance

Based on cash, cash equivalents and marketable securities as of March 31, 2026, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029.

(Press release, Immuneering, MAY 15, 2026, View Source [SID1234665770])

On May 15, 2026 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, reported financial results for the first quarter ended March 31, 2026, and provided a comprehensive business update.

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CEO Commentary:

"Our progress in the first quarter of 2026 reflects continued execution against our core mission of developing therapeutics capable of addressing the significant unmet need in mental health," said Joseph Tucker, Ph.D., Chief Executive Officer of Enveric Biosciences. "We remain laser focused on advancing EB-003, Enveric’s lead drug candidate in development, toward an IND submission and first-in-human clinical trials."

Dr. Tucker continued: "What differentiates Enveric is our commitment to harnessing the therapeutic potential of psychedelic-inspired mechanisms while designing our candidates to eliminate the hallucinogenic effects that limit scalability, safety, and broad patient access. Our growing body of preclinical data continue to support EB-003’s ability to promote neuroplasticity through selective receptor engagement, reinforcing our confidence in its potential to deliver rapid and durable antidepressant and anxiolytic effects."

"Since the end of the first quarter, the broader policy environment appears to be increasingly supportive of innovation in mental health. Recent actions, including an Executive Order issued under President Donald Trump emphasizing the importance of advancing novel treatments for mental health conditions, underscore growing recognition of the therapeutic promise of psychedelic-inspired compounds. We believe the future of this field will be defined by non-hallucinogenic neuroplastogens like EB-003, which is designed to deliver the benefits of these pathways while avoiding the limitations associated with traditional psychedelic therapies."

Dr. Tucker continued: "In parallel, we continue to view our intellectual property estate as a foundational driver of long-term value creation. The recent withdrawal of the Post-Grant Review petition by AbbVie further underscores the strength, breadth and strategic relevance of our patent portfolio. We believe our expanding IP position not only protects our innovations but also enhances our ability to create future partnering and monetization opportunities."

Dr. Tucker concluded: "With IND-enabling activities underway and a strong intellectual property position, we believe Enveric is well positioned to generate meaningful value for stockholders as we transition toward the clinical phase of drug development."

FIRST QUARTER 2026 AND RECENT BUSINESS HIGHLIGHTS

Corporate, Product and Business Development Highlights:

EB-003 Development:

Reported EB-003 BRET receptor engagement assay data, demonstrating dual Gq and β-arrestin signaling at 5-HT2A, pathways that have been linked in peer-reviewed studies to antidepressant and anxiolytic effects
Subsequent to the end of the first quarter, highlighted positive results for EB-003 indicating a rapid reduction in conditioned fear response in a validated preclinical model of PTSD, supporting continued development for patient population with significant unmet need
Intellectual Property:

Announced the withdrawal of the Post-Grant Review (PGR) petition, which had been filed by Gilgamesh Pharmaceuticals, pertaining to patents that appear relevant to the bretisilocin (GM-2505) molecule, which was acquired by AbbVie, Inc. in $1.2 billion deal
Added depth to EVM301 intellectual property portfolio for non-hallucinogenic treatment of neuropsychiatric conditions, enhancing the patent claim coverage of Enveric’s N-heterocycle substituted tryptamine derivative molecules
Registered five of the Company’s trademarks, including its house marks, Enveric and Enveric Biosciences, with the Canadian Intellectual Property Office
Corporate & Financial:

Raised gross proceeds of approximately $1.5 million through a registered direct offering, priced At-The-Market under Nasdaq rules
Expanded collaboration with TOTEC Pharma through trademark license and option, out-licensing RCANN trademark portfolio
Subsequent to the end of the first quarter:
Raised an additional approximately $1.5 million from the exercise of warrants and;
Closed a private placement, priced At-The-Market under Nasdaq rules, of up to $13.9 million, including $5 million upfront with up to approximately $8.9 million potential additional proceeds upon exercise in full of warrants
FIRST QUARTER FINANCIAL RESULTS

Net loss attributable to stockholders was $1.6 million for the first quarter ended March 31, 2026, including $0.1 million in net non-cash expense, with a basic and diluted loss per share of $1.08, as compared to a net loss of $2.2 million, including $0.3 million in net non-cash income, with a basic and diluted loss per share of $14.58 for the quarter ended March 31, 2025. The Company had cash-on-hand of $4.9 million for the quarter ended March 31, 2026. For the quarter ended March 31, 2026, the Company raised gross proceeds, through offerings, of $2.8 million.

"In April 2026, Enveric completed a private placement expected to generate gross proceeds of up to $13.9 million, including $5.0 million received at closing, and assuming full exercise of the warrants issued in the private placement. In addition, the Company received $1.5 million from the exercise of Series G and H warrants at an exercise price of $4.16 per share," said Kevin Coveney, CPA, Chief Financial Officer. "As of May 15, 2026, the Company’s cash balance was approximately $10.3 million. Enveric believes these funds will support the completion of preclinical development activities for EB-003, the planned filing of an IND application, and operations into the first quarter of fiscal year 2027."

(Press release, Enveric Biosciences, MAY 15, 2026, View Source [SID1234665769])