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Enochian søger at hente 29 mio. USD efter positiv melding om, at FDA vil holde et møde

Morten W. Langer

mandag 14. juni 2021 kl. 21:27

Enochian oplyser:

Enochian BioSciences Announces $29 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Jun. 14, 2021 2:53 PM ETGlobeNewswireEnochian Biosciences, Inc. (ENOB)

LOS ANGELES, June 14, 2021 (GLOBE NEWSWIRE) — (NASDAQ: ENOB) — Enochian BioSciences, Inc. (ENOB), a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, today announced that it has entered into a definitive securities purchase agreement with several institutional investors for the issuance and sale of an aggregate of 3,866,667 shares of its common stock at a purchase price of $7.50 per share of common stock a registered direct offering priced at-the-market under Nasdaq rules. The registered direct offering is expected to close on or about June 16, 2021, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering are expected to be approximately $29 million before deducting placement agent fees and other offering expenses. Enochian currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

The securities described above are being offered pursuant to Enochian’s shelf registration statement on Form S-3 (File No. 333-239837) filed with the Securities and Exchange Commission (the “SEC”) on July 13, 2020 and declared effective on July 20, 2020. Such securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

A final prospectus supplement and the accompanying prospectus relating to the securities being offered in the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: placements@hcwco.com or by telephone: (212) 856-5711.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of any of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.


Enochian BioSciences Announces FDA Acceptance of Pre-IND Request For Potential HIV Cure

(ØU’s kommentar:The goal of a PreIND Meeting is to receive confirmation from FDA that the drug development plan and future clinical trials are acceptable to the Agency. As such, it is critical for Sponsors to remember that complete transparency with the FDA is necessary to obtain the maximum value from the meeting.- FDA har altså accepteret at holde et møde med Enochian om en eventuel plan og fremtidige klinkske forsøg med ENO)

Jun. 14, 2021 7:00 AM ETGlobeNewswireEnochian Biosciences, Inc. (ENOB)

LOS ANGELES, June 14, 2021 (GLOBE NEWSWIRE) — Enochian BioSciences, Inc. (ENOB), a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, today announced that the FDA has accepted a Pre-IND (Investigational New Drug) request for a potential functional cure or treatment of HIV. Written comments are expected this Fall.

Dr. Serhat Gumrukçu, co-founder and inventor of Enochian BioSciences, and Director of Seraph Research Institute (SRI), submitted the Pre-IND. The request was based on the results of a 54-year old man living with HIV who had failed to suppress the virus with antiviral therapy. The patient subsequently achieved viral control for 255 days with an innovative treatment of Natural Killer (NK) and Gamma Delta T-cells (GDT) collected from another person. During the entire period, no antiviral drugs were given. It is believed that the GDT cells, a small subset of immune cells that can be infected with HIV, could be a key factor in controlling the virus.

The findings were presented during the Conference of the American Society of Gene and Cell Therapy this past May. Presentations can be found at Enochianbio.com/Collaborations

Enochian BioSciences holds the exclusive license for the proprietary technology.

This innovative cellular therapy could be an important approach to achieve a “functional cure” of HIV, potentially allowing persons with the virus to stop antiviral treatment for extended periods of time. The Pre-IND submission requested that the novel strategy be extended to persons with HIV who have achieved suppression of the virus with antiviral treatment.

Dr. Mark Dybul, a prominent expert in HIV and Executive Vice Chairperson of the Board of Enochian BioSciences said: “As an HIV researcher, clinician and past leader of large, global HIV programs, I am very excited by the FDA’s decision to provide responses to the Pre-IND submission. Because the promising early results are only in one person, it is important to study the approach in a larger population. In addition, because many people achieve suppression with antiviral treatment, it is key to extend the evaluation to that specific group. Pre-IND is an important step to exploring the possibility of testing this novel NK-GDT treatment.”

Dr. Peter Piot, the former head of UNAIDS and Director of the London School of Hygiene and Tropical Medicine in London, said: “It is important to explore any potential for persons with HIV to safely stop antiviral drugs and control the virus. Although the results so far are preliminary and in one person, if the NK-GDT therapy is proven to be effective in others, it could offer hope to many who experience significant side effects from, or have grown tired of, daily antiviral medication.”

About Enochian BioSciences, Inc.
Enochian BioSciences, Inc. is a biopharmaceutical company dedicated to identifying, developing, manufacturing, and commercializing gene-modified cell therapy. The company’s gene-modified cell therapy platform can be applied to multiple indications, including HIV/AIDS and Oncology. For more information, please visit Enochianbio.com

About Seraph Research Institute (SRI)
Seraph Research Institute is a Los Angeles-based non-profit research institution, which runs basic science, translational and clinical research in pursuit of cures and effective treatments for chronic viral infections, cancers, and genetic disorders. For more information, please visit Seraphinstitute.org

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