On May 1, 2024 Akari Therapeutics, Plc (Nasdaq: AKTX, "Akari") and Peak Bio Inc. (OTC: PKBO, "Peak") reported completion of a joint portfolio prioritization review pursuant to which the combined entity, following completion of the previously announced merger of Akari and Peak, will focus on Peak’s ADC (antibody drug conjugate) platform technology and Akari’s PAS-nomacopan Geographic Atrophy (GA) program (Press release, Akari Therapeutics, MAY 1, 2024, View Source [SID1234642502]). Peak’s ADC platform technology is a proprietary technology using antibody plus linker plus Peak Bio toxin with immune modulation and includes a novel pre-clinical ADC candidate targeting TROP-2. Akari’s PAS-nomacopan is a bispecific complement and leukotriene B4 inhibitor with prolonged duration of action being developed for GA.

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"As part of the merger process, the boards of each company collaboratively decided on this portfolio prioritization plan. The boards believe by prioritizing the ADC and PAS-nomacopan GA programs the post-closing combined company will be in the best position to secure business development opportunities and funding while continuing to advance these important programs," said Hoyoung Huh, M.D., Ph.D. Chairman, Peak Bio, and Ray Prudo, M.D. Chairman, Akari Therapeutics.

Key Elements of Program Prioritization

ADC toolkit (proprietary technology using antibody plus linker plus Peak Bio toxin with immune modulation)

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Oncology platform includes a novel pre-clinical ADC candidate targeting TROP-2
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Strategy includes continued IND enabling development

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Strategy includes developing and progressing our novel toxin(s) including our lead toxin, PH-1 (Thailanstatin) which can be used in multiple important cancer targets including our TROP-2 candidate
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Ongoing and continued business development activities with significant market interest in ADC candidates
PAS-nomacopan for Geographic Atrophy

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Complement only inhibitors recently approved for treatment of GA
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PAS-nomacopan has been shown in animal models to have prolonged biologic residence in the eye, suggesting ability for q2 to q4 month dosing, a potentially important competitive advantage
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PAS-nomacopan, with its unique, non-pegylated bispecific inhibition of leukotriene B4 and complement may offer safety and/or efficacy advantages over traditional complement inhibitors
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Continued IND enabling development including full scale manufacturing of drug for clinical use with a pre-IND meeting expected 1H 2024
Programs for Further Evaluation

HSCT-TMA

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Akari’s HSCT-TMA program will be suspended, with enrollment in its currently active pediatric clinical study discontinued due to cost and timeline
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The post-closing combined company will work closely with FDA to define the best path forward for this technology
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Based upon cost and timeline. will consider the opportunity for partnership and licensing, specifically as it relates to the Priority Review Voucher (PRV)
PHP 303 (5th generation Neutrophil Elastase Inhibitor)

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Peak Bio’s Phase II ready PHP 303 program for Alpha 1 anti trypsin deficiency (AATD), a rare orphan condition, will be discontinued

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The post-closing combined company will continue ongoing business development discussions around this technology
Nomacopan

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Continue to seek partnership opportunities for licensing, proof of concept studies, and clinical trials
About the Merger

On March 5, 2024, Akari and Peak Bio announced a definitive agreement to merge as equals in an all-stock transaction. The combined entity will operate as Akari Therapeutics, Plc, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX, under the Chairmanship of Hoyoung Huh, MD, PhD. Under the terms of the agreement, Peak stockholders will receive a number of Akari ordinary shares (represented by American Depositary Shares) for each share of Peak stock they own, as determined on the basis of the exchange ratio described in the agreement. The exchange is expected to result in implied equity ownership in the combined company of approximately 50% for Akari shareholders and approximately 50% for Peak stockholders on a fully diluted basis, subject to adjustment under certain circumstances, including based on each party’s relative level of net cash at the closing of the proposed transaction. The transaction is expected to close by the third quarter of this year subject to the satisfaction of customary closing conditions, including approval by the shareholders of both companies.

On May 01, 2024 Aileron Therapeutics, Inc. ("Aileron") (NASDAQ: ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, reported the pricing of an underwritten registered direct offering priced at-the-market under Nasdaq rules of 4,273,505 shares of its common stock and accompanying warrants to purchase an aggregate of 4,273,505 shares of common stock (Press release, Aileron Therapeutics, MAY 1, 2024, View Source [SID1234642501]). Each share of common stock and accompanying warrant are being sold together at a combined public offering price of $4.68. The aggregate gross proceeds of the offering are expected to be approximately $20 million, before deducting underwriting discounts and commissions and other offering expenses payable by Aileron, and excluding any proceeds that may be received from exercise of the warrants. The offering is expected to close on or about May 3, 2024, subject to the satisfaction of customary closing conditions.

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The accompanying warrants will have an exercise price of $4.68 per share, will be exercisable immediately and will expire three years from the date of issuance. Aileron may call the warrants for cancellation during the ten trading day period after the date that is thirty (30) days following the public announcement by Aileron of the top-line results from the Phase 1b clinical trial of LTI-03 in patients with idiopathic pulmonary fibrosis, which announcement includes a statement that there were no drug-related adverse events that resulted in a discontinuation of the trial; provided that Aileron may only deliver such call notice if the volume-weighted average price of its shares of common stock exceeds the exercise price of the warrants on the trading day immediately prior to the date it delivers the call notice. Any warrant subject to such call for which a notice of exercise is not received will be cancelled ten trading days after the date of the call notice for consideration equal to $0.001 per warrant share.

Titan Partners Group, a division of American Capital Partners, is acting as sole book-running manager for the offering.

The securities were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-265470) that was previously filed with and declared effective by the Securities and Exchange Commission (SEC) on June 16, 2022. The offering was made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. A final prospectus supplement relating to the offering will be filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained for free by contacting Titan Partners Group, LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, by phone at (929) 833-1246 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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.