On May 16, 2023 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, reported the presentation of the trial in progress (TIP) FRIDA poster entitled Iadademstat in combination with gilteritinib for patients with mutated FLT3 relapsed/refractory acute myeloid leukemia at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting, to be held in-person from June 2-6, 2023 at the McCormick Place in Chicago, Illinois (Press release, Oryzon, MAY 16, 2023, View Source;utm_medium=email&utm_campaign=NdP.11+17-05-2023+FRIDA-ASCO+ENG594 [SID1234631787]).

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Dr. Amir Fathi, Director of the Leukemia Program at Massachusetts General Hospital, is the Principal Investigator of the study and first author of the poster. He will be recording a brief video summarizing the poster information and study status.

Dr. Douglas V. Faller, Oryzon’s Global Chief Medical Officer, will attend the poster presentation, which will take place during the Poster Discussion Session on Monday June 5 from 8:00 AM-11:00 AM within the Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Session.

FRIDA (NCT05546580) is an open-label, multicenter study of iadademstat plus gilteritinib for the treatment of patients with relapsed or refractory AML (R/R AML) with FLT3·mutations. The trial’s primary objectives are to evaluate the safety and tolerability of iadademstat in combination with gilteritinib in patients with FLT3mut+ R/R AML and to establish the Recommended Phase 2 Dose (RP2D) for this combination. Secondary objectives include evaluation of the treatment efficacy, measured as the rate of complete remission and complete remission with partial hematological recovery (CR/CRh), the duration of responses (DoR) and the assessment of measurable residual disease (MRD). FRIDA will be conducted in 10-15 sites in the US. The study will enroll up to approximately 45 patients and if successful, the Company and FDA have agreed to hold a meeting to discuss the best plan to further develop this combination in this much in need AML population.

Presentation materials will be available both on the ASCO (Free ASCO Whitepaper) website and on our website under the Events section following the session.

On May 16, 2023 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company developing intratumoral immunotherapies to stimulate the patient’s immune system to target cancer cells and eradicate disease, reported that it has entered into a definitive agreement for the purchase and sale of an aggregate of 1,408,384 shares of its common stock (or common stock equivalents in lieu thereof), at a purchase price of $0.945 per share (or common stock equivalent in lieu thereof), in a registered direct offering priced at-the-market under Nasdaq rules (Press release, OncoSec Medical, MAY 16, 2023, View Source [SID1234631786]). The Company has also agreed to issue in a concurrent private placement unregistered warrants to purchase up to an aggregate of 1,408,384 shares of common stock. The warrants will have an exercise price of $0.82 per share, are immediately exercisable upon issuance, and will expire five and one-half years from the date of issuance. The closing of the offering is expected to occur on or about May 18, 2023, subject to the satisfaction of customary closing conditions.

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

The gross proceeds to the Company from the offering are expected to be approximately $1.33 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering as working capital for general corporate purposes.

The securities described above (excluding the warrants and the shares of common stock underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-260850) that was originally filed with the Securities and Exchange Commission (the "SEC") on November 8, 2021, and declared effective on November 15, 2021. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

On May 16, 2023 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel small molecule therapeutics to benefit people with rare diseases of the immune system, reported that it has agreed to sell an aggregate of 42,784,203 shares of common stock (or pre-funded warrants in lieu thereof) to certain institutional accredited investors in a private investment in public equity (PIPE) financing (Press release, X4 Pharmaceuticals, MAY 16, 2023, View Source [SID1234631784]). X4 anticipates that gross proceeds from the PIPE will be approximately $65 million, before deducting fees to the placement agents and other estimated offering expenses payable by the Company. The closing of the financing is expected to occur on or about May 18, 2023, subject to customary closing conditions.

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In addition, as previously announced, X4 will present additional results from its global, pivotal, Phase 3 clinical trial (4WHIM) evaluating the safety and efficacy of mavorixafor in people with WHIM syndrome at a company webinar to be held today, May 16, 2023, at 4:00 p.m. ET. The live webinar can be accessed here. The webcast can also be accessed on the investor relations section of X4’s website at www.x4pharma.com.

The PIPE financing included participation from new and existing investors including New Enterprise Associates (NEA), Bain Capital Life Sciences, Adage Capital Management, Stonepine Capital Management, LLC, Acorn Bioventures, OrbiMed, Kingdon Capital, and other healthcare specialist investors.

Piper Sandler and Stifel served as lead placement agents. Cantor acted as co-placement agent and H.C. Wainwright & Co. acted as financial advisor for the offering.

Inclusive of the net proceeds from this transaction, X4 now expects its cash and cash equivalents to fund operations into the fourth quarter of 2024, excluding the potential proceeds from the sale of a priority review voucher, for which the company is eligible and may receive in the first half of 2024.

Pursuant to the terms of the securities purchase agreement, at the closing of the PIPE, X4 will issue an aggregate of 42,784,203 shares of common stock (or pre-funded warrants in lieu thereof). The purchase price per share is $1.52 (or $1.519 per pre-funded warrant). The price per share was based in part upon the Nasdaq official closing price.

X4 expects to use these funds for continued clinical development and commercial readiness of its lead candidate, mavorixafor, and for working capital, and general corporate purposes.

The securities sold in this financing are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. X4 has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock and the shares of its common stock underlying the pre-funded warrants sold in this financing.

On May 16, 2023 Sigyn Therapeutics, Inc. ("Sigyn" or the "Company") (OTCQB: SIGY), a development-stage medical technology company, reported its financial results for the first quarter ended March 31, 2023 (Press release, Sigyn Therapeutics, MAY 16, 2023, View Source [SID1234631783]).

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During the quarter, the Company continued its focus to initiate first-in-human clinical studies of Sigyn Therapy as a candidate to treat pathogen-associated inflammatory disorders. The therapeutic blood purification technology has been demonstrated to deplete a broad-spectrum of inflammatory cytokines, viral pathogens, and bacterial toxins from human blood plasma. First-in-human clinical studies are directed toward the enrollment of end-stage renal disease patients with endotoxemia and concurrent inflammation.

Additionally, the Company recently introduced a development-stage cancer treatment system comprised of ChemoPrep to enhance the delivery of chemotherapeutic drug agents and ChemoPrep to reduce the toxicity of chemotherapy.

Summary of First Quarter 2023 Financial Results

For the quarter ended March 31, 2023, the Company had a loss from operations of approximately $521,000, compared to an operating loss of approximately $609,000 for the comparable period of 2022. The Company’s net loss for the 2023 first quarter was approximately $1,341,000 or approximately $0.03 per share, compared to a net loss of approximately $678,000, or approximately $0.02 per share, for the comparable period in 2022. First quarter 2023 net cash used in operating activities was approximately $563,000.

For complete financial results, please see Sigyn Therapeutics’ filings at www.sec.gov, and on the Company’s website at www.SigynTherapeutics.com under "Financial Info" in the Investors section.

On May 16, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported it will host a virtual panel discussion on Tuesday, May 30, 2023 at 8:00 a.m. EST (Press release, Sellas Life Sciences, MAY 16, 2023, View Source [SID1234631782]).

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The panel will feature hematology-oncology specialists Tapan Kadia, MD (The University of Texas MD Anderson Cancer Center), Joshua Zeidner, MD (University of North Carolina Lineberger Comprehensive Cancer Center), and Omer Jamy, MD (O’Neal Comprehensive Cancer Center at the University of Alabama) who will discuss the treatment landscape for acute myeloid leukemia (AML) and the potential for GFH009 to address unmet medical needs for patients with relapsed and/or refractory AML.

GFH009 is a clinical stage small molecule, highly selective CDK9 inhibitor that SELLAS is investigating for treatment of patients with hematologic malignancies and solid tumors. SELLAS plans to commence a Phase 2a clinical trial during the second quarter of 2023 with GFH009 in combination with venetoclax and azacitidine in AML patients.

A live question and answer session will follow the formal discussion and a replay of the event will be available on SELLAS’s website. To register for the event, please click here.