On January 30, 2025 Novartis reported Fourth Quarter and Full Year 2024 financial results (Presentation, Novartis, JAN 30, 2025, View Source [SID1234650116]).

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On January 30, 2025 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported the pricing of a public offering of an aggregate of 1,666,666 shares of its common stock (or common stock equivalents in lieu thereof), Series A warrants to purchase up to 1,666,666 shares of common stock and Series B warrants to purchase up to 1,666,666 shares of common stock, at a combined public offering price of $3.00 per share (or per common stock equivalent in lieu thereof) and accompanying warrants (Press release, Enveric Biosciences, JAN 30, 2025, View Source [SID1234649955]). The warrants will have an exercise price of $3.00 per share and will be exercisable immediately. The Series A warrants will expire five years from the date of issuance and the Series B warrants will expire eighteen months from the date of issuance. The closing of the offering is expected to occur on or about February 3, 2025, subject to the satisfaction of customary closing conditions.

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

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $5 million. The Company intends to use the net proceeds from this offering for product development, working capital and general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-284277), which was declared effective by the Securities and Exchange Commission (the "SEC") on January 30, 2025. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website 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 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 January 30, 2025 Orion Corporation ("Orion"), a globally operating pharmaceutical company, and Invenra Inc., an innovative biotechnology company with proprietary technologies for discovering novel therapeutics, reported that they have entered into a research collaboration to discover bispecific antibodies using Invenra’s B-Body platform (Press release, Orion, JAN 30, 2025, View Source [SID1234649972]).

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Under the terms of the agreements, Invenra will leverage its B-Body bispecific antibody platform from monoclonal antibody discovery to optimized panels of bispecific leads. Orion will be responsible for the selection of targets and will be solely responsible for the development, manufacturing, and global commercialization of these candidates. The agreement provides Orion with commercial licenses for up to two bispecific antibodies.

"This collaboration highlights the strength and versatility of our B-Body platform in addressing complex biological challenges," said Roland Green, CEO of Invenra. "We are thrilled to work with Orion, a company that shares our commitment to delivering innovative therapies that address critical unmet medical needs."

"Partnering with Invenra represents an important step in Orion’s strategy to expand our portfolio in the bispecific antibody space," said Antti Haapalinna, Vice President, Head of External Science & Partnering R&D, Orion. "Invenra’s cutting-edge bispecific discovery platform, combined with Orion’s expertise in development and commercialization, will accelerate the creation of impactful new therapies for patients worldwide."

This discovery collaboration combines Invenra’s advanced engineering expertise in bispecific antibody discovery with Orion’s established track record in pharmaceutical innovation, setting the stage for the development of next-generation therapeutic solutions.

On January 30, 2025 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported the pricing of a public offering of an aggregate of 3,997,361 of its American Depositary Shares ("ADSs") and warrants to purchase up to 50% of the ADSs offered at a combined public offering price of $2.71 per ADS with one accompanying warrant for each two ADSs (Press release, Evaxion Biotech, JAN 30, 2025, View Source [SID1234649956]).

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MSD Global Health Innovation Fund, a corporate venture capital arm of Merck & Co., Inc., Rahway, NJ, USA, who became an Evaxion shareholder in December 2023, is also participating in this offering along with healthcare-focused investment funds. There is also participation from Evaxion’s Board of Directors and Management.

The warrants will have an exercise price of $2.71 per ADS, will be exercisable immediately upon issuance and will expire five years following the date of issuance. Each ADS represents fifty ordinary shares of the company. The closing of the offering is expected to occur on or about January 31, 2025, subject to the satisfaction of customary closing conditions.

Lake Street Capital Markets, LLC and Jones are acting as the exclusive placement agents for the offering. The gross proceeds to the company from the offering are expected to be $10.8 million, before deducting the placement agent’s fees and other offering expenses payable by the company. The company intends to use the net proceeds of this offering to advance the company’s preclinical and clinical pipeline, and for continuing operating expenses and working capital.

The securities described above are being offered pursuant to a registration statement on Form F-1, as amended (File No. 333-283304), which was declared effective by the Securities and Exchange Commission ("SEC"), on January 29, 2025. The offering is made only by means of a prospectus forming a part of the effective registration statement relating to the offering.

A preliminary prospectus relating to the offering has been filed with the SEC and a final prospectus relating to the offering will be filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website located at View Source and may also be obtained by contacting Lake Street Capital Markets, LLC at Attn: Syndicate Department, 920 Second Avenue South, Suite 700, Minneapolis, MN 55402, by calling (612) 326-1305, or by emailing [email protected] or JonesTrading Institutional Services LLC ("Jones") at Attn: Equity Capital Markets, 325 Hudson Street, 6th Floor, New York, NY 10013, by emailing [email protected].

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 January 30, 2025 Owkin, the first end-to-end AI-biotech that uses agentic AI to revolutionize drug discovery, development, and diagnostics, reported that the first patient has been dosed in its Phase I clinical trial of OKN4395 on January 22, 2025 (Press release, Owkin, JAN 30, 2025, View Source [SID1234649973]). OKN4395 builds upon well-characterized EP2/EP4 inhibition, through a newly identified and equipotent inhibition of DP1. The clinical significance of this first-in-class triple inhibition is being evaluated in this trial.

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AI-optimized study design

Owkin’s proprietary K1.0 Operating System was instrumental in advancing OKN4395 from asset selection through to clinical development. By building a detailed biological understanding of the EP2/EP4/DP1 targets and their complex mechanisms of action, Owkin’s AI operating system was used to optimize the clinical development strategy. The program integrates Owkin’s expertise in AI-driven indication selection, external control arms (digital twins) for early anti-tumor activity insights in Phase I, and biomarker-led patient subtyping to enhance the probability of clinical success.

Thomas Clozel, MD, CEO & Co-founder of Owkin, said: "OKN4395 reflects not only a decade of discovery efforts by Idorsia and its collaborators but also exemplifies the transformative power of Owkin’s K1.0 Operating System. This milestone underscores our ability to rapidly translate a promising asset into an AI-optimized clinical program."

A first-in-class asset: OKN4395

Prostaglandins E2 and D2 (or PGE2, PGD2) are hormone-like molecules produced naturally in the body, and are the natural ligands for prostanoid receptors EP2, EP4, and DP1, respectively. The PGE2/EP2/EP4 and PGD2/DP1 pathways are both known to be immunosuppressive1,2. Well-described in oncology, hyperactivity of the PGE2/EP2/EP4 pathway in certain cancers allows them to avoid the immune system’s effector mechanisms, leading to progression and resistance through tumor growth or metastasis1.

OKN4395 is the first compound in the clinic to selectively inhibit EP2, EP4, and DP1 receptors. This novel mechanism offers the potential to restore immune function, providing transformative treatment options for patients with advanced solid tumors.

The INVOKE Study (OKN-4395-121)

INVOKE is a global, multicenter, Phase Ia/1b, first-in-human, open-label trial evaluating OKN4395 in patients with advanced solid tumors. Phase Ia primarily assesses safety and tolerability through dose escalation of OKN4395 as both a monotherapy and in combination with pembrolizumab. Phase Ib will expand into a further four cohorts, and assess preliminary anti-tumor activity, as well as safety and extensive exploratory analyses.