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.

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]).

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])

On February 28, 2025 Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its first-in-class immunocytokine designed to address the unmet need in patients with solid tumors refractory to anti-PD-1 therapy (Press release, Fapon Biopharma, FEB 28, 2025, View Source [SID1234650762]).

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FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action (MOA) and therapeutic potential for anti-PD-1 naïve or resistant patients. IL-10 monomer (IL-10M) engineering significantly reduces its hematologic toxicity, while the anti-PD-1 antibody enhances IL-10M activity by PD-1 targeted enrichment and cis-activation.

PD1 targeted antibodies drive the differentiation of effector CD8(+) T cells into terminally exhausted status. In the latest pre-clinical experiment conducted by Fapon Biopharma, FP008 effectively counteracted this process through IL-10M, significantly reducing the anti-PD-1 antibody-mediated exhaustion of CD8(+) T cells. In mouse experiments, FP008 exhibited potent anti-tumor effects, significantly increased the infiltration of intratumoral CD8(+) T cells, reduced their terminal exhaustion differentiation and enhanced the ability of terminally exhausted CD8(+) T cells to produce and secrete IFN-γ and GZMB. In addition, FP008 showed encouraging safety and pharmacokinetics profile in cynomolgus monkey, and demonstrated favorable developability.

This breakthrough offers a new treatment choice for patients who have limited options and could potentially transform the treatment paradigm for solid tumors. Fapon Biopharma is actively seeking strategic partnerships with biopharmaceutical companies worldwide to co-develop FP008 through clinical trials or further commercialization.

"Global collaboration is central to our vision," stated President Vincent Huo. "We invite partners to leverage our robust preclinical data and clinical-stage asset to jointly advance innovative products in tumor immunotherapy."

On February 28, 2025 TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics ("BBOT"), a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3Kα malignancies, and Helix Acquisition Corp. II (Nasdaq: HLXB) ("Helix"), a special purpose acquisition company (SPAC) sponsored by affiliates of Cormorant Asset Management, reported that they have entered into a definitive business combination agreement (Press release, BridgeBio, FEB 28, 2025, View Source [SID1234650763]). Upon closing of the transaction, the combined company will be renamed "BridgeBio Oncology Therapeutics, Inc." The combined company’s common stock is expected to be listed on Nasdaq under the ticker symbol BBOT.

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"Management—Directors’ Fiduciary Duties and Conflicts of Interest"

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In addition to approximately $196 million held in Helix Acquisition Corp. II’s trust account (assumed as of the closing and assuming no redemptions by Helix’s public shareholders), the transaction also includes commitments for an approximately $260 million PIPE from a group of premier institutional investors. The PIPE is led by Cormorant Asset Management and includes ADAR1 Capital Management, BC Capital, investment funds affiliated with Deerfield Management Company, Enavate Sciences, Eventide Asset Management, Novo Holdings A/S, Octagon Capital, Omega Funds, Paradigm BioCapital Advisors, StemPoint Capital LP, Surveyor Capital (a Citadel company), Wellington Management, and another leading mutual fund.

Eli Wallace, PhD, Chief Executive Officer of BBOT, said, "This financing and transaction mark a significant milestone for our company. We are profoundly grateful to the patients who participate in our trials, our dedicated BBOT team members, and our investors. We believe this transaction is the optimal path to advance our programs and make a meaningful impact on patients affected by deadly cancers."

Net proceeds from the transaction are expected to provide BBOT with the capital needed to accelerate the development of three lead programs: BBO-8520, BBO-10203, and BBO-11818. BBO-8520 is a direct inhibitor of KRASG12C in both the "ON" and "OFF" states and is currently being evaluated in the Phase 1 ONKORAS-101 trial (NCT06343402) for patients with KRASG12C mutant non-small cell lung cancer. BBO-10203 is an orally bioavailable small molecule with a novel mechanism of action that is designed to inhibit the physical interaction between RAS and PI3Kα, resulting in the inhibition of RAS-driven PI3Kα-AKT signaling in tumors. BBO-10203 is being evaluated in the Phase 1 BREAKER-101 trial (NCT06625775) for patients with locally advanced and unresectable or metastatic HER2+ breast cancer, HR+/HER2- breast cancer, KRAS mutant colorectal cancer and KRAS mutant non-small cell lung cancer. BBO-11818 is a pan-KRAS inhibitor targeting mutant KRAS in both the "ON" and "OFF" states with strong potency against KRASG12D and KRASG12V mutants. BBOT expects to dose the first patient with BBO-11818 in the first half of 2025.

Bihua Chen, Founder and Chief Executive Officer of Cormorant, and Chief Executive Officer of Helix, said, "BBOT’s team has some of the brightest minds in oncology, with a proven track record of developing new medicines. The company’s pipeline has the potential for paradigm-shifting impact on the treatment of some of the highest prevalence malignancies and we look forward to seeing patient impact further materialize as the clinical trials move forward."

Transaction Overview

Upon the closing of the business combination, BBOT expects it will have access to approximately $550 million in cash (prior to the payment of transaction costs of BBOT and Helix and assuming no redemptions by Helix’s public shareholders and existing BBOT cash at closing of $100 million). The proceeds will be funded through a combination of approximately $196 million held in a trust account by Helix (assumed as of the closing and assuming no redemptions by Helix’s public shareholders) and an approximately $260 million concurrent PIPE financing of common stock issued at the SPAC redemption price per share to leading institutional investors. Assuming a share price of $10.36 per share and no redemptions of Helix shares by Helix’s public shareholders, BBOT (as a combined entity) is expected to have an implied pro forma equity value of approximately $949 million at closing. BBOT shareholders will not receive any cash proceeds as part of the transaction and will roll 100% of their equity into the combined company.

The boards of directors of both BBOT and Helix have approved the proposed transaction, which is expected to be completed in the third quarter of 2025. The transaction is subject to, among other things, the approval of the stockholders of both BBOT and Helix, and satisfaction or waiver of the conditions stated in the definitive business combination agreement.

Leerink Partners, Morgan Stanley, Cantor, and Oppenheimer & Co. acted as placement agents for Helix in connection with the PIPE transaction. Leerink Partners also acted as lead capital markets advisor to Helix. Piper Sandler acted as capital markets advisor to BBOT. Goodwin Procter acted as legal counsel to BBOT. White & Case LLP acted as legal counsel to Helix. Kirkland & Ellis LLP acted as legal counsel to the placement agents.

Additional information about the transaction will be provided in a Current Report on Form 8-K to be filed by Helix with the SEC and will be available at the SEC’s website at www.sec.gov.