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.

Curadel Pharma secures $10.5M in series A2 funding to propel novel Zwitterionic Radiotherapy Platform

On March 1, 2025 Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and imaging drugs, reported completion of a Series A2 funding round, securing $10.5M to advance early stage development for its lead programs.

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"We are building a strong body of evidence that our zwitterionic platform has broad applicability in the oncology landscape and the funding we’ve attracted from strong investment partners demonstrates the enthusiasm for this opportunity," said John Brimacombe, Curadel President. "Building upon strong proof of concept data in imaging drugs, we are now focused on applying the power of zwitterionicity to deliver profound improvements in the outcomes associated with TATs, initially for rare cancers."

The most recent funding aims to support critical validating steps for the platform and the lead candidate CPI-003, including proof of synthesis studies, preclinical development and regulatory preparations. Work continues on ZW800-1, Curadel’s imaging drug, which is under evaluation in a pivotal trial led by a Tier 1 medical device company.

(Press release, Curadel Pharma, MAR 1, 2025, View Source [SID1234662084]).

Algok Bio and Institute of Cancer Research (ICR) Launch Phase 1b Trial of Idetrexed with PARP Inhibitor Lynparza for Ovarian Cancer

On March 1, 2025 Algok Bio Inc. (Algok Bio), a US-based biopharmaceutical company dedicated to researching and developing innovative therapeutics for unmet medical needs, reported the company has initiated a Phase 1b clinical trial for its lead drug candidate, Idetrexed, in collaboration with the UK’s Institute of Cancer Research (ICR). Launched on February 28, 2025, the trial evaluates Idetrexed in combination with AstraZeneca’s PARP inhibitor Lynparza (olaparib) for platinum-resistant ovarian cancer patients with medium to high FRα expression.

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Since acquiring the global development and commercialization rights for Idetrexed from BTG International, a subsidiary of Boston Scientific, in 2023, Algok Bio has been advancing both a monotherapy trial (Phase 2) and a combination study with a PARP inhibitor. This latest trial aims to establish the optimal dosage (Phase 1b) and assess safety and efficacy (Phase 2a), with objective response rate (ORR) and progression-free survival (PFS) as key endpoints.

The Phase 1b study follows a dose-optimization strategy, starting with Lynparza at its approved monotherapy dosage of 300 mg twice daily, with potential stepwise reductions to 200 mg and 150 mg twice daily. Idetrexed will be administered at doses up to one level below the optimal monotherapy dosage to determine the maximum tolerated dose (MTD) of the combination therapy.

Idetrexed’s FRα-targeting mechanism offers a distinct advantage over existing treatments, maximizing therapeutic effects while maintaining a strong safety profile. In a prior Phase 1 monotherapy study, Idetrexed demonstrated fewer side effects, higher patient compliance, and superior efficacy across a broader range of FRα expression levels compared to existing FRα-targeting antibody-drug conjugates (ADCs).

"Many combination therapies with PARP inhibitors have faced challenges, but Idetrexed’s unique synergy and non-overlapping side effects with PARP inhibitors set it apart," said Dr. Sung Chul Kim, President of Algok Bio. "This trial represents a significant step in offering a new treatment option for ovarian and gynecological cancers."

Additionally, Idetrexed has potential applications beyond ovarian cancer, as FRα is overexpressed in more than 90% of ovarian cancer cases and is also present in other epithelial-derived malignancies, including endometrial, pancreatic, breast, lung, gastric, and colorectal cancers.

With the global ovarian cancer market projected to reach $6.7 billion by 2028, Algok Bio remains committed to advancing targeted therapies that address critical unmet medical needs, both as monotherapy and combination treatments.

(Press release, Algok Bio, MAR 1, 2025, View Source [SID1234662154])

Magnet Biomedicine Enters into a Collaboration and License Agreement with Lilly to Discover and Develop Novel Molecular Glue Medicines

On February 28, 2025 Magnet Biomedicine, a leading biopharmaceutical company advancing molecular glue discovery with rational selection and design, reported a collaboration and license agreement with Eli Lilly and Company to discover, develop, and commercialize molecular glue therapeutics in oncology (Press release, Magnet Biomedicine, FEB 28, 2025, View Source [SID1234650760]). The collaboration will leverage Magnet’s TrueGlue discovery platform to identify molecular glues capable of inducing protein proximity and cooperativity, enabling novel mechanisms of action to address difficult-to-drug targets spanning multiple diseases with unmet medical need.

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"This collaboration supports our differentiated approach and efforts to reimagine what’s achievable through the next generation of molecular glues to drive breakthrough therapies," said Brian Safina, Ph.D., CEO of Magnet. "Lilly’s commitment to innovation and deep expertise in bringing transformative medicines to patients make it an ideal partner for Magnet as we harness the untapped potential of molecular glues."

Under the terms of the agreement, Magnet will receive upfront, near-term payments and an equity investment of up to $40 million. Magnet is also eligible to receive a total of more than $1.25 billion in milestones upon achievement of certain development, regulatory, and commercial milestones, as well as tiered royalties on global net sales.

About TrueGlue discovery platform
Magnet’s TrueGlue discovery platform utilizes state-of-the-art screening technologies, proprietary chemical libraries, and strategic selection of target and presenter proteins to rationally and systematically identify TrueGlues. These small molecules induce proximity and promote cooperativity between proteins, enabling precise drug targeting to disease-relevant tissues and addressing historically difficult-to-drug proteins.

Nuvalent to Participate in Upcoming March Investor Conferences

On February 28, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in fireside chats during the following March investor conferences (Press release, Nuvalent, FEB 28, 2025, View Source [SID1234650761]):

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TD Cowen 45th Annual Health Care Conference on Wednesday, March 5, 2025 at 9:50 a.m. ET in Boston;
Leerink Global Healthcare Conference 2025 on Monday, March 10, 2025 at 10:40 a.m. ET in Miami, FL; and,
Barclays 27th Annual Global Healthcare Conference on Wednesday, March 12, 2025 at 2:30 p.m. ET in Miami, FL.

Live webcasts will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentations.