On July 7, 2023 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported the closing of its previously announced registered direct offering for total gross proceeds of $25 million, before deducting the placement agents’ fees and other offering expenses (Press release, Abeona Therapeutics, JUL 7, 2023, View Source [SID1234633104]).

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"Our existing institutional investors have shown their confidence in Abeona by participating in this registered direct offering without discounts or warrant coverage," said Vish Seshadri, Chief Executive Officer of Abeona. "We have been very encouraged by the favorable feedback and insights from healthcare professionals, patient communities, payors and hospital administrators based on the results of EB-101 in clinical trials, and we are positioned to launch EB-101 in the U.S. without depending on a partner. The $25 million offering allows us to now start preparing for the commercialization of EB-101 and aim for a timely launch upon potential BLA approval in the first half of 2024, while also extending our cash runway well into the fourth quarter of 2024."

Abeona will use the net proceeds from the offering primarily to fund preparations for commercialization of its product candidate EB-101, as well as for working capital and general corporate purposes. Based on EB-101’s Rare Pediatric Disease designation, Abeona expects to qualify to receive a priority review voucher (PRV) upon Biologics License Application (BLA) approval and subject to final determination by the FDA. The PRV can be used to receive an expedited review process of a subsequent marketing application for a different product or sold to another company to create additional capital.

The Company sold 3,284,407 shares of its common stock (and, in lieu of common stock for certain investors, pre-funded warrants to purchase 2,919,140 shares of its common stock) at an offering price of $4.03 per share (or $4.0299 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant). The pre-funded warrants are immediately exercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the pre-funded warrants are exercised in full.

The offering was led by Nantahala Capital Management, LLC and included participation by Adage Capital Partners LP and two other existing investors.

Cantor Fitzgerald & Co. acted as the sole lead-placement agent for the offering. A.G.P./Alliance Global Partners acted as the co-placement agent for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-256850) that was filed with the Securities and Exchange Commission (the "SEC") on June 7, 2021 and amended on August 27, 2021 and October 19, 2021, and was declared effective by the SEC on October 22, 2021. The prospectus supplement and the accompanying prospectus that form a part of the registration statement have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, or by e-mail at [email protected].

The securities described above have not been qualified under any state blue sky laws. This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Abeona being offered, and shall not constitute an offer, solicitation or sale of any security 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.