On December 2, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano, a clinical-stage nanomedicine company, reported new data demonstrating that its proprietary Deciparticle platform enables broad and consistent formulation of structurally diverse hydrophobic therapeutics-including macrolide mTOR inhibitors, cyclic peptides, linear peptides, ascomycin macrolactams, and polyketides-while maintaining a precise sub-20 nm nanoparticle profile suitable for intravenous (IV) delivery.

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These findings, presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), confirm that the Deciparticle technology represents a chemically versatile, cGMP-ready delivery platform with the potential to support an expanding pipeline of oncology and immunology drug products.

Presentation info: PS4-04-21. Deciparticle Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing. Sheng-Hao Min, Kevin Forero, Johnathan Anderson, William Putnam, Can Evizi, Cassidy McCallum, Robert Hoff, Mark Ostrander, and Kwun Ho.

Deciparticle Platform Demonstrates Broad Formulation Capability Across Therapeutic Classes

New data from a comprehensive screening effort show that Sapu Nano’s optimized polymer reproducibly forms monodisperse nanoparticles (~15 nm) capable of encapsulating multiple classes of hydrophobic drugs:

Macrolide mTOR Inhibitors

All five clinically relevant macrolide immunosuppressants formed stable Deciparticles:

Sirolimus
Temsirolimus
Ridaforolimus
Umirolimus
Everolimus
Differences in substitution at the C-40/C-42 or C-33 positions did not impair nanoparticle formation, highlighting the platform’s tolerance for structural diversity within the macrolide family.

Ascomycin Macrolactams

Tacrolimus formed stable sub-20 nm Deciparticles.
Pimecrolimus, while encapsulated, produced particle sizes above the Deciparticle threshold-defining a steric upper bound for the platform and its suitability for optimized macrolactam design.
Cyclic and Linear Peptides

The Deciparticle platform successfully formulated two medically important peptide classes:

Cyclosporine A (hydrophobic cyclic peptide)
Exenatide (synthetic linear peptide)
These findings demonstrate the platform’s ability to handle both compact hydrophobic macrocycles and amphipathic linear peptides-an important expansion for peptide-based therapeutic pipelines.

Robust and Scalable cGMP Manufacturing

The platform is supported by Sapu Nano’s ISO-5 cGMP facility capable of:

One-pot bulk drug manufacturing
Sterile filtration
Automated fill/finish
Lyophilization into a stable, clinic-ready drug product
High batch reproducibility
Days to weeks post-reconstitution stability
Precision particle-size control with tight lot-to-lot consistency

This cGMP infrastructure enables fast, reliable translation from formulation to Phase 1 supply, supporting multiple INDs annually.

"With these new data, the Deciparticle platform has emerged as a broad, modular nanomedicine engine capable of formulating multiple classes of hydrophobic drugs that were previously constrained by solubility and delivery barriers," said Dr. Vuong Trieu, Chief Executive Officer of Sapu Nano. "This platform advances beyond single-asset value to a multi-asset opportunity across oncology, immunology, and peptide therapeutics. Sapu003 is only the beginning."

About the Deciparticle Platform

The Deciparticle platform is a proprietary nanotechnology engineered to encapsulate hydrophobic molecules as uniform, sub-20 nm nanoparticles for intravenous administration. The platform improves systemic exposure, reduces GI deposition, and supports precision delivery while maintaining manufacturability at clinical scale.

(Press release, Oncotelic, DEC 2, 2025, View Source [SID1234661057])

On December 2, 2025 Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies reported that that it intends to develop its fully human anti-IL-6 receptor (IL-6R) monoclonal antibody, TZLS-501, and related assets (together "TZLS-501") via a spinout into a separate publicly traded company, to enhance the strategic focus of each company and to drive value for shareholders. Tiziana shareholders at the record date will retain value from TZLS-501 through the distribution in specie of shares in the new TZLS-501 listed entity.

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The Company recently announced that it would advance development of TZLS-501, a dual-action IL-6R monoclonal antibody targeting both membrane-bound and soluble forms of IL-6R. This decision was based in part on heightened industry interest in the IL-6 pathway—underscored by Novartis’ recent $1.4 billion acquisition of Tourmaline Bio for its IL-6 inhibitor pacibekitug. The Company considers TZLS-501 as having the potential to be a standalone business. Accordingly, the Company intends to proceed with steps for a publicly listed immunology-focused spin-out company, centered on the IL-6 market. The record date for this proposed transaction will be announced in the coming weeks and the transaction will formally be put to shareholders of Tiziana for approval. TZLS-501 will remain an asset of Tiziana Life Sciences until such time as shareholders formally approve proposals for the spin-out entity.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: "The recent Novartis acquisition of Tourmaline Bio for $1.4 billion highlights the tremendous value and strategic importance of IL-6 pathway therapeutics in addressing systemic inflammation and related diseases. Building on our September announcement to advance TZLS-501, we believe now is the ideal time to position this promising asset as a standalone entity. TZLS-501’s unique dual mechanism—blocking IL-6R signaling while reducing circulating IL-6 cytokines—offers significant potential as a monotherapy or in combination with other agents. This spin-out will unlock dedicated resources for its development, while allowing us to maintain focus on intranasal foralumab as our lead program."

There can be no certainty that the transaction will proceed and any listing will be subject to meeting the required listing criteria.

About TZLS-501

TZLS-501, a fully human mAb, was licensed from Novimmune, SA, (Geneva, CH) in 2017. IL-6 is a cytokine that binds to its receptor subunit IL-6Rα on the cell membrane, and is a major determinant in priming of pathogenic T cells to produce an inflammatory response. The receptor IL-6Rα can be shed in soluble form, sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from this complex mediates pro-inflammatory effects underlying inflammatory diseases. TZLS-501 acts via a dual mechanism by inhibiting IL-6R signaling and depleting circulating levels of IL-6.

On December 2, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that its request for a Type C Meeting with the FDA has been accepted by the agency, and the meeting has been scheduled to occur this month.

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The meeting was requested to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The request is based on positive final results from the Company’s VERSATILE-002 trial, which showed promising median overall survival (mOS) and durable progression-free survival (PFS) in patients with CPS ≥ 1. The proposed amendment to the VERSATILE-003 Phase 3 trial would change the PFS endpoint to become a surrogate primary endpoint that can be evaluated earlier with significant statistical power, potentially forming the basis for accelerated approval of PDS0101. mOS will remain as the primary endpoint for full approval as originally recommended by FDA.

"We believe the positive PFS data from VERSATILE-002 offers an important opportunity to shorten duration to a primary endpoint and potentially accelerate our path to regulatory submission, while still preserving mOS and safety assessment as the endpoint for full FDA approval," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We are confident that the accelerated pathway we are seeking could expedite the availability of this promising treatment to patients in need, and we look forward to exploring this approach in greater detail with the FDA. We will provide further updates once we receive the FDA’s meeting minutes in January 2026."

(Press release, PDS Biotechnology, DEC 2, 2025, View Source [SID1234661052])

On December 2, 2025 Pasithea Therapeutics Corp. ("Pasithea" or the "Company") (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), reported the closing of its previously announced public offering of 80,000,000 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.75 per share of common stock (or per pre-funded warrant in lieu thereof). The public offering was led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners and Squadron Capital Management.

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

The gross proceeds to the Company from the offering were approximately $60 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes. The Company expects its cash position to extend its cash runway through at least the first half of 2028. Such corporate purposes include, without limitation, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to the Company’s technologies, licensing activities related to its current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-291611) originally filed with the Securities and Exchange Commission ("SEC") on November 18, 2025, as amended on November 26, 2025, and declared effective on November 28, 2025. The offering was made only by means of a prospectus, which is part of the effective registration statement. A final prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the 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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Pasithea Therapeutics, DEC 2, 2025, View Source [SID1234661051])

On December 2, 2025 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported its participation in the Evercore 8th Annual Healthcare Conference on Thursday in Miami.

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Evercore 8th Annual Healthcare Conference
December 4, 2025
10:50 a.m. ET – fireside chat

A simultaneous webcast of the event will be available on the Investors section of Nkarta’s website, and a replay will be archived on the website for approximately 90 days.

(Press release, Nkarta, DEC 2, 2025, View Source [SID1234661050])