On May 3, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (the "Company") reported that it has closed the first tranche (the "First Tranche") of its previously announced non-brokered private placement (the "Private Placement") with the issuance of 5,126,574 units (the "Units") of the Company at a price of $0.065 per Unit for aggregate gross proceeds of $333,227.31 (Press release, BioVaxys Technology, MAY 3, 2024, View Source [SID1234642638]).

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Each Unit consists of one common share in the capital of the Company (each, a "Share") and one whole common share purchase warrant (each, a "Warrant"), whereby each Warrant is convertible into one additional Share at an exercise price of $0.15 until May 3, 2026, being the date that is 24 months from the date of issue.

In connection with the closing of the First Tranche of the Private Placement, the Company paid cash finder’s fees in the aggregate of $6,500 and issued a total of 60,000 finder’s warrants (each, a "Finder’s Warrant"). Each Finder’s Warrant is also convertible into an additional Share at an exercise price of $0.15 until May 3, 2026.

The Company intends to use the net proceeds of the First Tranche for general working capital purposes, including, enabling the Company to fund and advance its business plans in regard to its successful recent acquisition on February 16, 2024, of the entire portfolio of discovery, preclinical and clinical development stage assets in oncology, infectious disease, antigen desensitization, and other immunological fields based on the DPX immune educating platform technology, developed by the former Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., and IMV USA.

All securities issued pursuant to the First Tranche are subject to a statutory hold period under applicable Canadian securities laws expiring September 4, 2024, being the date that is four months and one day from the date of closing of the First Tranche.

The Company anticipates closing the second and final tranche (the "Final Tranche") of the Private Placement within the next two weeks. Closing of the Final Tranche is subject to the receipt of all necessary regulatory approvals, including approval of the Canadian Securities Exchange.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities offered have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws, unless an exemption from such registration is available.

On May 3, 2024 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the first quarter ended March 31, 2024 (Press release, Werewolf Therapeutics, MAY 3, 2024, View Source [SID1234642636]).

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"Werewolf continues to focus on the execution of our lead clinical programs WTX-124 and WTX-330, with updates planned for later in the second quarter. At ASCO (Free ASCO Whitepaper), we plan to share data from the dose-escalation portion of our Phase 1/1b trial evaluating WTX-124 as a single agent and in combination with pembrolizumab. In addition, we look forward to sharing interim, first-in-human monotherapy dose escalation data from the ongoing Phase 1/1b trial of WTX-330 in the second quarter." said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "We continue to execute on our pipeline of INDUKINE molecules in oncology and immunology and are now projecting our financial runway to run through at least the first quarter of 2026."

Recent Highlights and Upcoming Milestones

WTX-124: a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule being developed as monotherapy and in combination with pembrolizumab in multiple solid tumor types.
•At the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the Company will present additional interim data from the monotherapy dose-escalation arm and preliminary dose-escalation data from the combination arm of its ongoing Phase 1/1b clinical trial of WTX-124. Details for the poster presentation are as follows:
◦Title: A phase 1/1b study of the IL-2 prodrug WTX-124 in patients with locally advanced or metastatic solid tumors after checkpoint inhibitor therapy: Initial results of the combination dose escalation with pembrolizumab
◦Session Date: Saturday, June 1, 2024
◦Session Time: 9:00 AM-12:00 PM CDT
•Werewolf remains on track to select a recommended dose for expansion and initiate monotherapy dose expansion arms in the first half of 2024.
WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in advanced or metastatic solid tumors.
•In the second quarter of 2024, Werewolf plans to present interim first-in-human data from Study WTX-330×2101, its Phase 1, multi-center, open-label clinical trial evaluating WTX-330 as a monotherapy in patients with immunotherapy insensitive or resistant advanced or metastatic solid tumors or non-Hodgkin lymphoma.
•Werewolf recently received U.S. Food and Drug Administration alignment on the comparability path for an improved manufacturing process which Werewolf expects to integrate into the clinical development program.

Preclinical Portfolio: includes development candidates WTX-712 and WTX-518, INDUKINE molecules targeting IL-21 and IL-18, respectively, for treatment of cancer and an INDUKINE molecule delivering IL-10 for treatment of Irritable Bowel Disease.
•During the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2024, Werewolf presented two posters detailing progress of WTX-518 and WTX-712 preclinical programs, which the Company is progressing through investigational new drug application-enabling work:
◦WTX-518: Poster entitled "WTX-518, an IL-18 pro-drug that is conditionally activated within the tumor microenvironment and induces regressions in mouse tumor models," demonstrated in vitro activity unimpeded by IL-18BP and selectivity that delivers active binding protein resistant (BPR) IL-18 to the tumor microenvironment, eliciting complete tumor regression in an MC38 mouse tumor model.
◦WTX-712: Poster entitled "WTX-712, a conditionally active IL-21 INDUKINETM molecule, induces a strong anti-tumor phenotype through a differentiated mechanism," demonstrated antitumor activity and tumor regression in the MC38 mouse tumor model. IL-21 was observed to achieve superior anti-tumor efficacy compared to IL-2 therapy in mouse tumor models that are highly resistant to anti-PD-1/PD-L1 treatment.
•During the American Association of Immunologists Meeting which begins May 3, 2024, Werewolf is presenting a poster entitled "Development of conditionally active IL-10 INDUKINETM molecules for the treatment of inflammatory bowel disease." These are the first data demonstrating application of the Company’s PREDATOR platform in immune-mediated disease, indicating that IL-10 INDUKINE molecules were peripherally inactive and conditionally active in target tissue thereby preventing intestinal histological damage and inhibiting inflammatory cytokine production in mouse models of colitis.
Additional Updates:
•In May 2024, Werewolf entered into a loan and security agreement with K2 HealthVentures, a healthcare focused specialty finance company, which provides Werewolf with access to up to $60.0 million in capital, $30.0 million of which was drawn at closing and, along with the Company’s existing cash, was used to repay the Company’s loan with Pacific Western Bank.
Financial Results for the First Quarter of 2024:
•Cash position: As of March 31, 2024, cash and cash equivalents were $139.2 million, compared to $134.3 million as of December 31, 2023. The Company also had restricted cash and cash equivalents of $21.2 million as of both March 31, 2024 and December 31, 2023, of which $20.0 million became unrestricted upon the repayment of the Pacific Western Bank loan. The Company believes its existing cash and cash equivalents at March 31, 2024, together with cash impacts of the loan refinancing, will be sufficient to fund operational expenses and capital expenditure requirements through at least the first quarter of 2026.
•Collaboration revenue: Collaboration revenue was $0.7 million for the first quarter of 2024, compared to $4.5 million for the same period in 2023. Collaboration revenue consists of revenue recognized from the Company’s licensing agreement with Jazz Pharmaceuticals (Jazz) and includes fixed payments received from Jazz, plus costs incurred for research services to be reimbursed by Jazz.
•Research and development expenses: Research and development expenses were $12.9 million for the first quarter of 2024, compared to $11.7 million for the same period in 2023. The increase in research and development expenses was primarily due to the Company’s development efforts for WTX-124 and WTX-330, which continue to progress through their respective clinical trials, resulting in higher clinical trial costs and higher manufacturing costs to support those trials.
•General and administrative expenses: General and administrative expenses were $5.0 million for each of the first quarters of 2024 and 2023.
•Net loss: Net loss was $16.2 million for the first quarter of 2024, compared to $12.0 million for the same period in 2023.

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.