Cullinan Therapeutics Licenses Rights to Velinotamig, a Clinical-Stage BCMA-Directed Bispecific T Cell Engager, from Genrix Bio for Development in Autoimmune Diseases

On June 4, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported that it has entered into an agreement with Genrix Bio for a global (ex-Greater China), all indication, exclusive license to velinotamig, a BCMAxCD3 bispecific T cell engager. Velinotamig has demonstrated potential best-in-class efficacy at the Phase 2 target dose in nearly 50 patients with relapsed/refractory (r/r) multiple myeloma (MM) (Press release, Cullinan Oncology, JUN 4, 2025, View Source [SID1234653706]). Cullinan will develop velinotamig in autoimmune diseases.

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"We believe T cell engagers represent the next wave of innovation in autoimmune diseases, and we are excited to build upon our core T cell engager expertise and extensive KOL relationships to develop another potential best-in-class, clinical-stage program. Accumulated data supports BCMA as a promising target in autoimmune diseases, offering a precise and potentially disease-modifying approach by eliminating the entirety of the self-reactive plasma cells that result in certain autoimmune diseases, especially those diseases driven by long-lived plasma cells," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. "Adding a BCMAxCD3 bispecific T cell engager to our pipeline complements our rapid global clinical development of CLN-978, enabling us to address the needs of more patients across a broader range of autoimmune diseases than with either molecule alone."

Genrix plans to initiate a Phase 1 study in China by the end of this year in patients with autoimmune diseases. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.

"With our planned Phase 1 study of velinotamig in autoimmune diseases, we will be able to quickly leverage our experience in autoimmune diseases to complete the study in China expeditiously," said Dr. Liu Zhigang, Chairman, Chief Executive Officer, and Chief Science Officer of Genrix Biopharmaceutical "Cullinan is a proven leader in developing T cell engagers and we are confident in the company’s ability to carry the program forward to address the needs of patients with autoimmune diseases."

Under the agreement, Cullinan will pay Genrix Bio an upfront license fee of $20 million for exclusive rights to develop and commercialize velinotamig in all disease areas globally outside of Greater China. In the future, Genrix will also be eligible to receive up to $292 million in development and regulatory milestones plus up to an additional $400M in sales-based milestones, as well as tiered royalties from mid-single digits up to the mid- teens on potential ex-Greater China net sales.

Importantly, with refinement of the clinical oncology pipeline, Cullinan reiterates its existing guidance to have cash resources into 2028 based on its current operating plan.

Niagen Bioscience to Present at Oppenheimer’s 25th Annual Consumer Growth and E-Commerce Conference

On June 4, 2025 Niagen Bioscience, Inc. (NASDAQ: NAGE) (formerly ChromaDex Corp.), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, reported that its Chief Executive Officer, Rob Fried, and Chief Financial Officer, Ozan Pamir, will participate in Oppenheimer’s 25th Annual Consumer Growth and E-Commerce Conference (Press release, ChromaDex, JUN 4, 2025, View Source [SID1234653705]).

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Mr. Fried is scheduled to participate in a fireside chat on Monday, Jun 9, from 2:15 p.m. to 2:50 p.m. Eastern Time (11:15 a.m. Pacific Time). To register for the Niagen Bioscience fireside chat webcast, please visit www.wsw.com.

Mr. Fried and Mr. Pamir will also hold one-on-one meetings with institutional investors throughout the day.

A replay of the webcast will be available following the event on the Niagen Bioscience Investor Relations website, www.investors.niagenbioscience.com. For additional information on Niagen Bioscience, visit www.niagenbioscience.com.

Taiho Pharmaceutical and SyntheticGestalt Implements Technology Validation Towards Generative AI-Driven Expansion of Cysteinomix Drug Discovery Platform

On June 4, 2025 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho Pharmaceutical") and SyntheticGestalt KK (hereinafter "SyntheticGestalt") reported that they have entered into an agreement to initiate technology validation to utilize SyntheticGestalt’s world largest molecular foundation AI model, aiming towards the further expansion and evolvement of Taiho Pharmaceutical’s proprietary drug discovery platform technology, Cysteinomix (Press release, Taiho, JUN 4, 2025, View Source [SID1234653704]).

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SyntheticGestalt has developed an innovative foundation AI model (SG4D10B*) which is trained on 10 billion compound data points. This foundation AI model features the ability to improve the prediction accuracy of molecular profiles for new compounds by learning a large amount of complex 3D structure molecules. By using this model as an additional learning and inference target in compound libraries owned by companies, each company can easily build its own exploration platform.
*SG4D10B: The world’s largest molecule-specialized foundation AI model developed by SyntheticGestalt. It solves the challenges of conventional molecular AI technologies, specifically low prediction accuracy and poor generalization performance. It enables high-precision model development even with small-scale data held by pharmaceutical companies and chemical manufacturers. It contributes to the efficiency of new drug and new material development through significant reduction in development time and research costs.This model was developed with support from GENIAC (Generative AI Accelerator Challenge) program implemented by Ministry of Economy, Trade and Industry (METI) and New Energy and Industrial Technology Development Organization (NEDO).

Taiho Pharmaceutical has established its unique drug discovery platform Cysteinomix, with its proprietary covalent compound library at its core. This platform has a track record of creating an agent already approved in Japan, the United States and Europe, and multiple agents currently in clinical development. In order to further strengthen and increase the competitive advantage of this drug discovery platform, the company is working to expand the application of Cysteinomix, including the discovery of covalent drugs targeting amino acids other than cysteine.

SyntheticGestalt’s CTO, Kotaro Kamiya commented, "By applying our 4D exploration technology, which incorporates spatial structures and charge information, to covalent drug libraries, we can contribute to the discovery of innovative covalent drugs."

Taiho Pharmaceutical’s Executive Director, Clinical Development and Medical Affairs, Discovery & Preclinical Research, Takeshi Sagara commented, "By applying SyntheticGestalt’s proprietary generative AI platform into our Cysteinomix drug discovery platform, we aim to increase the success rate of discovering covalent drugs for targets which have been considered as undruggable for a long time. We will continue to advance the discovery of innovative new drugs with Cysteinomix, and remain committed to provide cancer therapies which can support patients with cancer through their entire patient journey."

About Cysteinomix Drug Discovery
Cysteinomix is Taiho Pharmaceutical’s proprietary drug discovery platform to continuously generate covalent drugs in variety of cysteine-containing target proteins. Cysteinomix drug discovery platform consists of target protein database, covalent compound library, and various compound evaluation systems, and has a track record of creating multiple pipelines to date.
*Covalent drug: A drug which forms a covalent bond with a target protein to irreversibly control its function. It consists of a portion that binds to the pocket of the protein (ligand) and a portion that covalently binds to the specific amino acid (reactant group).

Merus N.V. Announces Pricing of Public Offering of Common Shares

On June 4, 2025 Merus N.V. (Nasdaq: MRUS) ("Merus", the "Company," "we" and "our"), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported the pricing of an underwritten public offering of 5,263,158 common shares, at a public offering price of $57.00 per share (the "Offer Shares") (Press release, Merus, JUN 4, 2025, View Source [SID1234653680]). Merus also granted the underwriters a 30-day option to purchase up to an additional 789,473 common shares (the "Option Shares" and together with the Offer Shares, the "Shares"). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses and excluding the underwriters’ option to purchase the Option Shares, are expected to be approximately $300.0 million. All of the shares in the offering are to be sold by Merus.

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The offering is expected to close on or about June 5, 2025, subject to customary closing conditions.

Merus currently intends to use the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to advance the clinical development of its product candidates, for preclinical research and technology development, and for working capital and general corporate purposes.

Jefferies, BofA Securities, Leerink Partners, Guggenheim Securities, Truist Securities, and LifeSci Capital are acting as joint book-running managers for the offering. Van Lanschot Kempen is acting as lead manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on February 28, 2024 and was effective upon filing. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, which, for the avoidance of doubt, will not constitute a "prospectus" for the purposes of (i) Regulation (EU) 2017/1129 (the "Prospectus Regulation") and has not been reviewed by any competent authority in any member state in the European Economic Area (the "EEA") and (ii) the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the "UK Prospectus Regulation") and has not been reviewed by the Financial Conduct Authority in the United Kingdom. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on June 3, 2025, and a final prospectus supplement will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; BofA Securities NC1-0220-02-25, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, NC 28255‐0001, or by email at [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; or Truist Securities, Inc., Attention: Equity Capital Markets, 3333 Peachtree Road NE, 9th Floor, Atlanta, GA 30326 at (800) 685-4786 or by email to [email protected].

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

This press release is an advertisement and not a prospectus within the meaning of either the Prospectus Regulation or the UK Prospectus Regulation.

EEA:

In relation to each member state of the EEA (each, a "Relevant State"), no Shares have been offered or will be offered pursuant to the offering to the public in that Relevant State prior to the publication of a prospectus in relation to the Shares which has been approved by the competent authority in that Relevant State or, where appropriate, approved in another Relevant State and notified to the competent authority in that Relevant State, all in accordance with the Prospectus Regulation, except that Shares may be offered to the public in that Relevant State at any time:

to any legal entity which is a "qualified investor" as defined under Article 2 of the Prospectus Regulation;
to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; and
in any other circumstances falling within Article 1(4) of the Prospectus Regulation,
provided that no such offer of the Shares shall require us or any of the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation. Each person who initially acquires any Shares or to whom any offer is made will be deemed to have represented, warranted, acknowledged and agreed to and with us and each of the underwriters that it is a "qualified investor" within the meaning of Article 2 of the Prospectus Regulation.

For the purposes of the above, the expression "offer to the public" in relation to the Shares in any Relevant State means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase or subscribe for any Shares, and the expression "Prospectus Regulation" means Regulation (EU) 2017/1129.

United Kingdom:

No Shares have been offered or will be offered pursuant to this offering to the public in the United Kingdom prior to the publication of a prospectus in relation to the Shares which has been approved by the Financial Conduct Authority in the United Kingdom, except that the Shares may be offered to the public in the United Kingdom at any time:

a) to any legal entity which is a qualified investor as defined under Article 2 of the UK Prospectus Regulation;

b) to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the UK Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or

c) in any other circumstances falling within Section 86 of the Financial Services and Markets Act 2000 (the "FSMA"),

provided that no such offer of the Shares shall require us or any of the underwriters to publish a prospectus pursuant to Section 85 of the FSMA or Article 3 of the UK Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the UK Prospectus Regulation. Each person in the United Kingdom who initially acquires any Shares or to whom any offer is made will be deemed to have represented, warranted, acknowledged and agreed to and with us and each of the underwriters that it is a "qualified investor" within the meaning of the UK Prospectus Regulation.

For the purposes of this provision, the expression an "offer to the public" in relation to the Shares in the United Kingdom means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase or subscribe for any Shares.

In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with persons who are "qualified investors" (as defined in the UK Prospectus Regulation) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the FSMA (Financial Promotion) Order 2005, as amended (the Order), and/or (ii) who are high net worth entities (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). In the United Kingdom, the securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person in the United Kingdom who is not a relevant person should not act or rely on this communication or any of its contents.

STADA’s continued, resilient growth leads to record earnings in Q1

On June 3, 2025 Stada, a leading healthcare company in Consumer Healthcare, Generics and Specialty pharmaceuticals, achieved record earnings on revenues growth in its financial first quarter ended 31 March 2025 (Press release, Stada, JUN 3, 2025, View Source [SID1234654337]).

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Group adjusted, constant-currency (cc) revenues advanced by 4% on an organic basis to €1.081 billion. This development was driven by a double-digit increase in revenues by the Group’s Specialty segment, aided by further market penetration with the Uzpruvo (ustekinumab) biosimilar launched in Europe from July 2024.

Adjusted cc earnings before interest, tax, depreciation and amortization (EBITDA) improved by 5% to €245 million, a historic high against a strong prior-year base.

"Our resilient business model delivered again in the first quarter of this year, as our diversified portfolio and broad footprint enabled us to overcome geopolitical challenges and market uncertainty," commented STADA’s CEO, Peter Goldschmidt. "Our symbiotic threesegment strategy gives us a broad basis for growth, with no dependence on individual products or countries."