Anixa Biosciences Announces Chief Development Officer Dr. Pam Garzone to Speak at the Alliance for Cancer Gene Therapy Summit 2025 on March 19th

On March 3, 2025 Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported Dr. Pam Garzone, Chief Development Officer of Anixa, will be attending the Alliance for Cancer Gene Therapy (ACGT) Summit 2025 and participating as a panelist on the Gynecologic and Breast Cancers panel (Press release, Anixa Biosciences, MAR 3, 2025, View Source [SID1234650823]). The Alliance for Cancer Gene Therapy Summit 2025 is being held on Wednesday and Thursday, March 19 – 20, 2025, at the Alexandria Center for Life Science in New York City.

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Dr. Garzone will join leading experts in the field to discuss advancements in cell and gene therapy, including Anixa’s CAR-T therapy for ovarian cancer, and its potential impact on gynecologic and breast cancers. The panel is scheduled for Wednesday, March 19, 2025, from 11:15 AM – 12:15 PM ET.

Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "We are pleased that Anixa and Dr. Garzone were invited to share insights at the ACGT Summit. Our discussions and contributions to the development of novel cancer therapies will help drive meaningful discussions on the future of gene-based treatments for gynecologic and breast cancers."

The Alliance for Cancer Gene Therapy Summit 2025 will bring together leading physician scientists advancing research to develop curative cell and gene therapies for solid tumor cancers.

For more information about the conference, visit Alliance for Gene Therapy Summit 2025.

AN2 Therapeutics to Present at Leerink Partners Global Healthcare Conference

On March 3, 2025 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, reported that Eric Easom, Co-Founder, Chairman, President and CEO, will present at the Leerink Partners Global Healthcare Conference (Press release, AN2 Therapeutics, MAR 3, 2025, View Source [SID1234650822]).

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Details of the event are as follows:

Leerink Partners Global Healthcare Conference

Eric Easom, Co-Founder, Chairman, President and CEO, will provide a corporate overview on Wednesday, March 12, 2025 at 2:20 pm ET, and members of management will be available for 1X1 meetings.

A webcast of the presentation can be accessed on the Investors section of the AN2 Therapeutics website at www.an2therapeutics.com. An archived replay will be available for at least 30 days following the presentation.

Alivexis Raises $0.7M USD Series D in Second Close

On March 3, 2025 Alivexis, Inc. (Headquartered in Minato-ku, Tokyo; CEO S. Roy Kimura, "Alivexis") a preclinical-stage computation-driven drug discovery firm, reported the second closing of its Series D round in the amount of 100M JPY (approximately $0.7M USD) (Press release, Alivexis, MAR 3, 2025, View Source [SID1234650821]). Investor participating in the second closing is Ohara Pharmaceutical Co., Ltd. (Headquartered in Koga City, Shiga Prefecture; CEO Seiji Ohara). The total amount raised in Series D round is 900M JPY (approximately $6.0 USD), and Alivexis has raised a total of 6.76B JPY (approximately $45.0M USD) to date.

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Alivexis will use the proceeds to further research and development programs utilizing its cutting-edge computational science-based drug discovery platform "ModBindTM", in addition to accelerating over 10 in-house R&D programs. Alivexis will expand key business strategies in early out-licensing and drug discovery collaboration, with the aim of further increasing its corporate value.

Comment from S. Roy Kimura, Ph.D., Co-founder and CEO:
"We are excited to announce the second closing of our latest funding round by Ohara Pharmaceutical Co., Ltd. Since our last fund-raise, we have successfully licensed our cathepsin C inhibitor program and are currently working together with our partner toward IND submission. We also published a scientific article on the first version of our ModBindTM simulation platform, based on a unique theoretical approach that enables accurate absolute ligand efficacy predictions at ~2000x speeds relative to existing methods. In the next several months, we expect to sign additional licensing partnerships from our portfolio of immunology and oncology R&D programs, as well as additional ModBindTM-related alliances and collaborations. We look forward to continuing our mission with our shareholders and partners to accelerate discovery of new medicines for patients and their families in need."

TYPE D MEETING OUTCOME WITH US FOOD AND DRUG ADMINISTRATION

On March 3, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported a regulatory update on its planned US clinical trial following its Type D meeting with the United States Food and Drug Administration (FDA) (Press release, Amplia Therapeutics, MAR 3, 2025, View Source [SID1234650784]).

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The Company has previously disclosed plans for a clinical trial in the US of its best-in-class FAK inhibitor narmafotinib, in combination with the chemotherapy regime FOLFIRINOX, in advanced pancreatic cancer patients. FOLFIRINOX, which is a mixture of four different drugs, is the preferred first-line treatment option for advanced pancreatic cancer in the US. The Company has previously reported1 that narmafotinib enhances the activity of FOLFIRINOX in preclinical models of pancreatic cancer.

A Type D meeting is an opportunity for a company to seek feedback from the FDA for specific questions regarding clinical development activities. The Company sought the FDA’s feedback regarding modifications to the clinical trial protocol previously submitted as part of the Investigational New Drug application cleared by the FDA in January 20242 . Specifically, the Company was seeking commentary regarding changes to the dose-escalation and dose-optimization phase of the study and concerning removal of a pharmacokinetic assessment of FOLFIRINOX in the trial. In the written response received by the Company, the FDA noted that the proposed changes ‘appear reasonable’ clearing the way for the Company to finalise the study protocol and initiate the final stages of trial planning prior to commencing the study.

Amplia CEO and MD Dr Chris Burns commented: "We are grateful for the thoughtful input from the FDA regarding the modifications to our clinical trial protocol. These changes will allow the Company to progress the trial in a more time-efficient and capital-efficient manner, and we are now in the final planning stages to start the trial in the coming months."

Dr Burns continued: "Positive data from this clinical study, combined with promising data from the current ACCENT trial – where narmafotinib is combined with gemcitabine and Abraxane – will position narmafotinib as the preferred drug to combine with the two main chemotherapy regimes used for the treatment of pancreatic cancer across the globe."

Entry into a Material Definitive Agreement.

On March 2, 2025, Akari Therapeutics, Plc (the "Company") reported to have entered into a securities purchase agreement (the "Purchase Agreement") with certain investors, including the Company’s Chairman, Dr. Hoyoung Huh, director, President and Chief Executive Officer, Dr. Samir R. Patel, and all other members of the Company’s board, pursuant to which the Company agreed to sell and issue in a private placement (the "Offering") an aggregate of 6,637,626 unregistered American Depository Shares ("ADSs"), each representing 2,000 of the Company’s ordinary shares (the "Shares"), or prefunded warrants in lieu thereof ("Pre-Funded Warrants"), and, in each case, Series A warrants to purchase ADS ("Series A Warrants") and Series B warrants to purchase ADS ("Series B Warrants", together with the Pre-Funded Warrants and Series A Warrants, the "Warrants," and together with the ADSs or Pre-Funded Warrants, the "Units")) (Filing, 8-K, Akari Therapeutics, MAR 2, 2025, View Source [SID1234650820]). The Units consist of (i) for investors committing less than $1.0 million in the Offering ("Tier 1 Investors") one ADS or Pre-Funded Warrant plus a Series A Warrant to purchase one ADS and a Series B Warrant to purchase one ADS, (ii) for investors committing at least $1.0 million but less than $3.0 million in the Offering ("Tier 2 Investors") one ADS or Pre-Funded Warrant plus a Series A Warrant to purchase 1.25 ADSs and a Series B Warrant to purchase one ADS, and (iii) for investors committing $3.0 million or more in the Offering ("Tier 3 Investors"), one ADS or Pre-Funded Warrant plus a Series A Warrant to purchase 1.5 ADSs and a Series B Warrant to purchase one ADS. The purchase price per Unit for investors purchasing ADSs is equal to $0.87 plus (a) $0.25 cents for Tier 1 Investors, (b) $0.28125 cents for Tier 2 Investors, or (c) $0.3125 for Tier 3 Investors (the "ADS Unit Purchase Price"). The purchase price per Pre-Funded Warrant and accompanying Series A Warrant and Series B Warrant is equal to $0.67 (which represents the ADS purchase price minus the $0.20 exercise price for such Pre-Funded Warrant) plus (a) $0.25 cents for Tier 1 Investors, (b) $0.28125 cents for Tier 2 Investors, or (c) $0.3125 for Tier 3 Investors (the "Pre-Funded Unit Purchase Price").

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In addition, Dr. Huh, the Company’s Chairman, agreed to purchase $1 million of Units, with the purchase price thereof to be satisfied through his agreement to terminate a $1 million convertible note previously issued to him by the Company (the "Note Termination").

The gross proceeds from the Offering, including the $1 million Note Termination, and excluding the proceeds to be received upon exercise of the Pre-Funded Warrants, are expected to be approximately $7.1 million before deducting approximately $401,000 representing the fees and expenses of the placement agent payable by the Company. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

The Series A and Series B Warrants will have an exercise price of $0.87 per ADS, which is equal to the Nasdaq official closing price of the Company’s ADSs on the Nasdaq Capital Market on February 28, 2025 and will be exercisable immediately following the date of issuance. The Series A Warrants and Series B Warrants will expire one year or five years, respectively, from the closing date of the Offering. The Pre-Funded Warrants will be exercisable immediately and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full.

The Company paid Paulson Investment Company, LLC ("Paulson") (the "Placement Agent") (i) a cash fee equal to 7% (or 3.5% for any investor that is a director, insider or affiliate of the Company) of the aggregate purchase price for the Units sold in the Offering (and excluding the Units issued to Dr. Huh in respect to the Note Termination) and (ii) 3% of the total number of ADS issued in the Offering, including any of the ADSs issuable upon exercise of the Pre-Funded Warrants (and excluding the ADSs issued to Dr. Huh in respect to the Note Termination).

Pursuant to the Purchase Agreement, the Company has agreed to prepare and file a registration statement on Form S-3 with the Securities and Exchange Commission no later sixty days following the closing of the Offering to register the resale of the Shares (including ADSs issuable upon exercise of the Warrants) purchased pursuant to the Purchase Agreement. The Purchase Agreement also contains representations, warranties, indemnification and other provisions customary for transactions of this nature. The Offering is expected to close on March 5, 2025, subject to the satisfaction of customary closing conditions.

The securities to be issued to the purchasers under the Purchase Agreement were offered in reliance on an exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and Rule 506 of Regulation D promulgated thereunder. The Company relied on this exemption from registration based in part on representations made by the purchasers, including that each purchaser is an "accredited investor", as defined in Rule 501(a) promulgated under the Securities Act.

The offer and sale of the securities pursuant to the Purchase Agreement have not been registered under the Securities Act or any state securities laws. The securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Neither this Current Report on Form 8-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein or therein.

The foregoing summary of the terms of the Warrants and the Purchase Agreement is subject to, and qualified in its entirety by, the full text of such agreements, which are filed as Exhibits 4.1, 4.2, 4.3 and 10.1, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.