On May 3, 2024 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that a late-breaking abstract featuring preclinical data from its FT522 program for autoimmune diseases will be featured at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting, being held in Baltimore, Maryland on May 7-11, 2024 (Press release, Fate Therapeutics, MAY 3, 2024, View Source [SID1234642631]).

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FT522 is the Company’s CD19-targeted, iPSC-derived CAR NK cell product candidate that incorporates its novel alloimmune defense receptor (ADR) technology, which is designed to increase the potency of off-the-shelf cell therapy and enable treatment without administration of conditioning chemotherapy to patients. At the ASGCT (Free ASGCT Whitepaper) conference, the Company will present multiple preclinical studies displaying the function of FT522 using peripheral blood mononuclear cells (PBMCs) sourced from unmatched donors with systemic lupus erythematosus (SLE). These preclinical data demonstrate rapid and deep B-cell depletion, enhanced functional persistence, and elimination of alloreactive host immune cells, indicating that FT522 may deliver therapeutic benefit to patients with autoimmune diseases without requiring administration of conditioning chemotherapy.

Late-breaking abstracts are available on the ASGCT (Free ASGCT Whitepaper) Annual Meeting website. Presentation details are as follows:

Presentation
FT522: A CAR NK Cell with the Unique Ability to Target Multiple Pathogenic Cell Types and Circumvent Lympho-conditioning in Systemic Autoimmunity
Late-Breaking Abstract Number: LBA-35
Session: Late-Breaking Abstracts
Location: Exhibit Hall
Presentation Date / Time: Thursday, May 9, 2024 12:00 PM

On May 3, 2024, Enveric Biosciences, Inc., a Delaware corporation (the "Company") entered into a series of common stock purchase agreements (the "Purchase Agreements") for the issuance in a registered direct offering of an aggregate of 458,000 shares of the Company’s common stock, par value $0.01 per share (the "Shares"), to certain institutional investors (Filing, 8-K, Enveric Biosciences, MAY 3, 2024, View Source [SID1234642630]). The issuance was made in exchange for the permanent and irrevocable waiver of the variable rate transaction limitation with respect to any existing or future agreement by the Company to effect any issuance of shares and issue such shares thereunder, as contained in those certain Inducement Offer Letters, dated December 28, 2023, between the Company and those certain institutional investors. The offering was conducted at a deemed offering price of $0.94 per share.

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The Purchase Agreements contain customary representations and warranties and certain indemnification obligations of the Company. The Purchase Agreements also restrict the Company from issuing, entering into any agreement to issue, or announcing the issuance of the Company’s common stock from the date of the Purchase Agreements until the earlier of 30 days after entering into the agreements or at such time as fifteen million (15,000,000) shares of the Company’s common stock have traded in the open market. The closing of the issuance of the Shares pursuant to the Purchase Agreements is expected to occur on May 6, 2024.

The Company will not receive any net proceeds in connection with the offering. This offering is being made to obtain a waiver of the variable rate transaction limitation as described above and further described in the Purchase Agreements so the Company can utilize its existing equity line of credit, which has been previously registered, and enter into any future agreements that involve a variable rate transaction and issue such shares thereunder.

This offering was made pursuant to the Company’s shelf registration statement on Form S-3, which was filed with the U.S. Securities and Exchange Commission (the "SEC") on July 2, 2021 and became effective on July 9, 2021 (File No. 333-257690), and a prospectus supplement and accompanying prospectus filed with the SEC.

The foregoing description of the Purchase Agreements is not complete and is qualified in its entirety by reference to the full text of the Purchase Agreements, a copy of the form is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated by reference herein.

A copy of the opinion of Dickinson Wright PLLC relating to the validity of the Shares is filed as Exhibit 5.1 to this Current Report on Form 8-K.

On May 3, 2024 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, reported it will host a Research and Development (R&D) Day to discuss the current unmet medical needs and the potential of Plinabulin as a novel immunochemotherapeutic in drug combinations, and updates for SEED Therapeutics on Wednesday, May 15th, 2024 at 10:00 a.m. ET (Press release, BeyondSpring Pharmaceuticals, MAY 3, 2024, View Source;utm_medium=rss&utm_campaign=beyondspring-to-host-virtual-rd-day-to-discuss-new-plinabulin-development-strategy-for-cancer-and-updates-for-seed-therapeutics [SID1234642628]).

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The conference call and webinar will feature presentations by Key Opinion Leaders (KOLs) Trevor M. Feinstein, M.D. (Piedmont Cancer Institute), Alberto Chiappori, M.D. (Moffitt Cancer Center), and Steven Lin, M.D. (MD Anderson Cancer Center), who will discuss below topics:

Plinabulin history and development strategy for cancer
Plinabulin’s immunomodulatory activity as a DC maturation agent
Unmet needs after immune-checkpoint-inhibitor failure
Also featured will be a management discussion on technology platform and pipeline updates of SEED Therapeutics, BeyondSpring’s majority-owned molecular glue subsidiary.

The dial in numbers for the conference call are 1-877-407-0779 (U.S.) or 1-201-389-0914 (international). To register for the webinar, please click here. An archived replay of the webinar will be available following the presentation on BeyondSpring’s website www.beyondspringpharma.com under "Events and Presentations" in the Investors section.

Trevor M. Feinstein, M.D.
Dr. Feinstein is board certified in medical oncology and hematology. He joined Piedmont Cancer Institute in 2011 and is the Director of Research at Piedmont Fayette Hospital. Dr. Feinstein is actively involved in clinical trials focused on improved therapies for various cancers. He is a member of Georgia CORE’s research committee along with Georgia Society for Clinical Oncology Clinical Practice Committee. He also chairs the Lung Disease Group for the entire OneOncology network. He is a co-investigator on several peer-reviewed research projects and has authored numerous publications and abstracts in Hematology and Oncology. Dr. Feinstein graduated from the University of Illinois medical school and completed his residence and fellowships at the University of Pittsburgh.

Alberto Chiappori, M.D.

Dr. Chiappori is board certified in medical oncology. He serves as senior member of oncology and medicine for the Thoracic Oncology Program at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and Florida. Dr. Chiappori is an active member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), the American Association for Cancer Research (AACR) (Free AACR Whitepaper), and the International Association for the Study of Lung Cancer (IASLC). Dr. Chiappori received his MD from the Universidad Peruana Cayetano Heredia in Lima, Peru, completed his residency at Southern Illinois University School of Medicine in Springfield, Illinois, and finished his fellowship and senior fellowship in medical oncology-hematology at Vanderbilt University School of Medicine in Nashville, Tennessee.

Steven Lin, M.D., Ph.D.
Dr. Lin is a Professor and Physician-Scientist at MD Anderson Cancer Center, with joint appointments in the Departments of Radiation Oncology and Experimental Radiation Oncology. Dr. Lin’s practice focuses on thoracic malignancies, and he oversees several clinical trials including the use of proton beam therapy for esophageal cancer and in the combination of immunotherapy with radiotherapy in lung and esophageal cancers. Dr. Lin runs a translational research team that evaluates biomarkers for treatment response and disease outcomes after cancer therapy. Dr. Lin acquired his M.D. and Ph.D. in the Medical Scientist Training Program at the University of California Irvine Medical School. He went on for residency training in Radiation Oncology at The Johns Hopkins Hospital.

On May 3, 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 closing of its previously announced 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 3, 2024, View Source [SID1234642625]). Each share of common stock and accompanying warrant were sold together at a combined public offering price of $4.68. The aggregate gross proceeds of the offering were 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.

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The accompanying warrants have an exercise price of $4.68 per share, are exercisable immediately and 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, acted 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 was filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. 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.

On May 3, 2024 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that the company is scheduled to present at the 2024 RBC Capital Markets Global Healthcare Conference on Tuesday, May 14, 2024, at 8:00 a.m. ET (Press release, Agios Pharmaceuticals, MAY 3, 2024, View Source [SID1234642624]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.