On September 18, 2025 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, reported the closing of its previously announced exercise of certain outstanding series A warrants to purchase up to an aggregate of 1,212,499 shares of common stock of the Company and series B warrants to purchase up to an aggregate of 1,212,499 shares of common stock originally issued in February 2025, having an exercise price of $3.00 per share, at a reduced exercise price of $0.915 per share (Press release, Enveric Biosciences, SEP 18, 2025, View Source [SID1234656065]). The shares of common stock issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form S-1 (No. 333-284277). The gross proceeds to the Company from the exercise of the warrants were approximately $2.2 million, prior to deducting placement agent fees and estimated offering expenses.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, the Company issued new unregistered series C warrants to purchase up to 2,424,998 shares of common stock and new unregistered Series D warrants to purchase up to 2,424,998 shares of common stock. The series C new warrants have an exercise price of $0.915 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the new warrants and will expire five years thereafter. The series D new warrants have an exercise price of $0.915 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the new warrants and will expire eighteen months thereafter.

The Company intends to use the net proceeds from the offering for product development, working capital and general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On June 3, 2025 Agenus and Zydus Pharmaceuticals (USA) Inc. entered agreements pursuant to which, (i) under an asset purchase agreement Zydus will acquire assets comprising the Company’s manufacturing operations, (ii) under a stock purchase agreement Zydus will acquire a minority position in the Company and (iii) under a license agreement Zydus will receive certain commercial rights in India and Sri Lanka relating to intellectual property associated with BOT/BOL (Filing, 8-K, Agenus, SEP 17, 2025, View Source [SID1234656166]). The Company and Zydus jointly submitted a filing to the Committee on Foreign Investment in the United States (CFIUS) to commence the CFIUS review process.

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On September 17, 2025, CFIUS requested that the Company and Zydus voluntarily submit a full notice application with CFIUS related to the transactions.

Based on the anticipated CFIUS review time related to the full notice filing the anticipated closing of these transactions has now shifted to the fourth quarter of 2025.

More detailed descriptions of the asset purchase agreement and stock purchase agreement are contained in our Current Report on Form 8-K filed with the SEC on June 4, 2025.

On September 17, 2025 TATUM bioscience, a preclinical biotechnology company developing a new immunotherapy to fight cancer, reported the publication of new research showing strong antitumor activity from its proprietary bioengineered multimodal nanofilaments (Press release, TATUM bioscience, SEP 17, 2025, View Source [SID1234656047]). The study, published in the new issue of the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC), details how this groundbreaking therapy exposes ("uncloaks") cancer cells and orchestrates a comprehensive immune response that eradicates tumors.

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"Our innovative nanofilament-directed immunotherapy overcomes cancer’s ability to hide from the immune system and unleashes a coordinated immune response against tumor cells," said Jean-François Millau, Ph.D., co-founder and Chief Executive Officer of TATUM Bioscience.

"The immune system can be compared to an orchestra: for a powerful antitumor response, each instrument — or cellular component — must play its part at the right moment. That’s what our drug candidate, TAT003, achieves." Dr. Millau is a co-author on the article, "Nanofilament immunotherapy induces potent antitumor vaccine responses."

How TAT003 Works

TAT003 is administered directly into the tumor ("intratumorally") and combines three biological functions to drive the immune system’s antitumor response:

Checkpoint Blockade: Anti–PD-L1 single-chain antibody fragments at one end of the nanofilament bind to tumor cells, decorating the tumor and blocking the PD-L1 immune checkpoint. This allows the immune system to recognize and target the cancer.
Innate Activation: Encapsulated within the nanofilament is a TLR9 agonist, which activates macrophages to engulf tumor cells. Activated macrophages present tumor antigens to the broader immune system.
T Cell Stimulation: IL-2 molecules on the nanofilaments stimulate T cells, triggering them to seek out and destroy other cells bearing tumor antigens — mimicking a vaccine-like response.
"Strikingly, the antitumor response triggered by TAT003 nanofilament immunotherapy was both systemic and durable in animal models," said Kevin Neil, Ph.D., co-founder and Chief Scientific Officer of TATUM. "Replicating these results in patients is our goal as we move toward clinical development."

Unique Advantages Over Personalized Vaccines

TATUM’s engineered nanofilaments offer distinct advantages over other therapeutic strategies. According to Dr. Neil, "TAT003 elicits a vaccine-like effect without the complexity and cost of individualized neoantigen vaccines, which require tumor sequencing and custom manufacturing for each patient. Our approach is designed to be more practical and scalable."

Manufacturing complex, multi-specific biologics remains a major challenge in biopharma. TAT003 addresses this with a proprietary synthetic biology platform: "We have engineered bacteria to function as miniature drug factories, producing fully assembled therapeutic nanofilaments in a single step," explained Dr. Millau. "We simply culture the bacteria, and they secrete the complete, functional drug."

Dr. Gerald Batist, director of the Segal Cancer Centre at Jewish General Hospital in Montréal, commented, "These results are highly promising and suggest that nanofilament-directed immunotherapy could overcome some of the limitations seen with today’s personalized neoantigen approaches. Engaging both innate and adaptive immunity, as shown here, is likely key to improving outcomes for patients who do not benefit from current immunotherapies. This represents a major step forward in the evolving landscape of immuno-oncology." Dr. Batist is a medical advisor to TATUM.

Looking Ahead

These findings represent a major milestone for TATUM Bioscience and the advancement of nanofilament-directed immunotherapy, paving the way for a powerful and innovative approach to treating solid tumors. TATUM is currently raising funds to accelerate development and bring TAT003 into clinical trials. The company welcomes interest from investors, partners, and clinicians seeking to be part of this next era in cancer immunotherapy.

On September 17, 2025 Purdue Pharma L.P. ("Purdue") reported that it has entered into an agreement to have its pipeline medication tinostamustine included in the Phase 2/3 GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) adaptive clinical trial for glioblastoma patients led by the Global Coalition for Adaptive Research (GCAR) (Press release, Purdue Pharma, SEP 17, 2025, View Source [SID1234656046]).

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Tinostamustine is a first-in-class, new chemical entity that combines two potentially synergistic mechanisms of action, bifunctional alkylating activity and pan histone deacetylase inhibition (or HDAC inhibition). Tinostamustine is under investigation in patients with glioblastoma, an aggressive brain cancer that is very challenging to treat and for which there is no cure.1 Most patients do not survive more than 15 months with current treatment approaches.1 Tinostamustine has the potential to be a first-line treatment. Nearly 14,000 people in the U.S. are diagnosed with glioblastoma each year. Tinostamustine will be investigated in patients with newly diagnosed glioblastoma as an adjuvant therapy following standard treatment with surgery, chemotherapy and radiation, as well as in patients with recurrent disease.

GBM AGILE is a pioneering, international adaptive platform trial designed to accelerate the identification of effective treatments for glioblastoma. It is led by GCAR, a non-profit corporation, and is supported by a global network of oncologists, neuro-oncologists, clinicians, researchers, biostatisticians, and patient advocates. Unlike traditional trials, GBM AGILE offers a seamless phase 2/3 design that supports a well-defined path for FDA registration. It allows for the simultaneous assessment of multiple investigational therapies against a common control arm, significantly reducing development time by adapting to emerging data and prioritizing promising new treatments.

"We are pleased to partner with GCAR in GBM AGILE to further study tinostamustine, which has shown promise in early trials," said Dr. Julie Ducharme, Vice President and Chief Scientific Officer, Purdue. "GBM AGILE accelerates the clinical trial timeline to speed medicines to patients, which aligns with our mission to address serious, unmet medical needs."

"We are pleased to be evaluating tinostamustine in GBM AGILE," said Dr. Meredith Buxton, Chief Executive Officer/President, GCAR. "Glioblastoma is the deadliest brain cancer, and our mission is to find promising new treatments to improve overall survival as compared to standard treatments. We are now hard at work collaborating on the Investigational New Drug Application (IND) and Clinical Trial Application (CTA) submissions necessary to include tinostamustine in our innovative and patient-centric adaptive trial."

The study is anticipated to begin following IND submission and FDA approval of the protocol with activation in Canada, Europe, and Australia to follow.

On September 17, 2025 ProteinQure, a Toronto-based biotech company pioneering computational peptide drug discovery, reported the successful dosing of the first patient in its Phase I clinical trial evaluating PQ203 – a novel, rationally designed peptide therapeutic for advanced metastatic solid tumors (Press release, ProteinQure, SEP 17, 2025, View Source [SID1234656043]).

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"Dosing our first patient with PQ203 represents a defining moment not just for ProteinQure, but for the vision from the founding of the company — that computational tools can unlock new medicines," said Lucas Siow, CEO and Co-Founder of ProteinQure. "Having created PQ203 in Toronto and starting the trial with the exceptional clinical team at Princess Margaret underscores the ability to advance world-class science in Canada."

The trial is being started at Princess Margaret Cancer Centre in Toronto, one of the world’s top five cancer research centers. There, the trial is led by investigator Dr. Philippe Bedard,

"It’s exciting to be part of a groundbreaking program that was discovered using the latest in computational science," said Dr. Bedard. "Peptides open up a new and promising path for targeted cancer treatments, and we’re looking forward to seeing how PQ203 might help patients who currently have limited treatment options."

About the Trial

The Phase 1 trial is a first-in-human trial with three parts: dose escalation, dose expansion (in multiple tumor types), and dose optimization. The study will evaluate the safety, tolerability, pharmacokinetics, preliminary activity, and pharmacodynamics of PQ203. It will take place across Canada and the US at clinical sites including Princess Margaret Cancer Centre, McGill, Yale, MD Anderson, and Next Oncology.

For more information about the PQ203 trial, visit www.clinicaltrials.gov (NCT# pending) or contact [email protected].

About PQ203

PQ203 is the company’s first internally owned AI designed peptide therapeutic entering the clinic 3 years after the program was started. PQ203 is composed of a peptide targeting the Sortilin receptor conjugated to the cytotoxic agent MMAE. The Sortilin receptor is expressed in a high percentage of diseased tissue from Triple Negative Breast Cancer (TNBC) patients. ProteinQure has generated data that PQ203 exhibits potent efficacy in a patient-derived xenograft (PDX) model resistant to Sacituzumab Govitecan (Trodelvy), an antibody drug conjugate that is the standard of care for metastatic TNBC.