Florida Cancer Specialists & Research Institute Studies Offer Innovative New Findings in the Diagnosis and Treatment of Gastrointestinal and Genitourinary Cancers at Global Symposium

On February 24, 2023 Innovations in cancer treatment resulting from research conducted through the Florida Cancer Specialists & Research Institute, LLC (FCS) Phase 1 Drug Development Units and at FCS clinics throughout Florida were reported recently at two global gatherings sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Florida Cancer Specialists & Research Institute, FEB 24, 2023, View Source;research-institute-studies-offer-innovative-new-findings-in-the-diagnosis-and-treatment-of-gastrointestinal-and-genitourinary-cancers-at-global-symposium-301755620.html [SID1234627686]).

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Two FCS studies of advanced treatments for solid tumors experienced in bladder, hepatobiliary and similar cancers were featured at both the ASCO (Free ASCO Whitepaper) 2023 Gastrointestinal (GI) Cancers Symposium and the ASCO (Free ASCO Whitepaper) 2023 Genitourinary (GU) Cancers Symposium:

A Phase 2 study investigating a treatment for patients with malignant solid tumors, co-authored by FCS medical oncologist/hematologist Maen A. Hussein, MD.
A first in human Phase 1 study co-authored by FCS medical oncologist/hematologist Cesar Augusto Perez, MD, evaluating a next-generation treatment for patients with advanced bile duct cancer (cholangiocarcinoma), a rare disease that affects the network of tubes connecting the liver, gallbladder and small intestine.
Clinicians and researchers from around the globe came together at the two symposiums to share the latest science and approaches in GI and GU cancer treatment, research and care. Genitourinary cancers, including kidney and bladder cancers, occur in the urinary system of men and women and in the reproductive organs in men, such as prostate and testicular cancers. Gastrointestinal cancers affect the digestive tract organs, such as the stomach, large and small intestine, pancreas, colon, liver, rectum, anus and biliary system.

"Research conducted with participation from FCS continues to contribute to advancements in the study, diagnosis and treatment of all forms of cancer, including GI and GU malignancies that impact women and men around the globe," said Gustavo Fonseca, MD, FACP, Medical Director of the FCS Clinical Research Program.

"Increasingly, our studies are revealing new discoveries in the use of targeted immunotherapies and molecular-based treatments that effectively block or inhibit the growth of cancer cells," said FCS Director of Drug Development Manish R. Patel, MD, who oversees the statewide practice’s three early phase Drug Development Units in Sarasota, Lake Mary and Lake Nona.

FCS President & Managing Physician Lucio Gordan, MD added, "These findings are positively impacting patient outcomes – improving cure rates and extending lives for women and men around the world."

Also included among the FCS medical oncologists/hematologists sharing the outcomes of FCS research studies in presentations at the ASCO (Free ASCO Whitepaper) GI Symposium was FCS Associate Director of Drug Development Judy S. Wang, MD.

Trial in progress: A phase 1, first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of ASP3082 in patients with previously treated advanced solid tumors and KRAS G12D mutations
Clinical and molecular presentation of KRAS G12D-mutated pancreatic ductal adenocarcinoma in real-world settings. Cesar Augusto Perez, MD was also a co-author.
The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Inc. (ASCO) (Free ASCO Whitepaper) represents nearly 45,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of high quality and equitable patient care, ASCO (Free ASCO Whitepaper) works to conquer cancer.

Entry into a Material Definitive Agreement.

On February 24, 2023 Aprea Therapeutics, Inc., a Delaware corporation (the "Company"), reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with Maxim Group LLC as representative of the underwriters named therein (the "Underwriters") relating to the issuance and sale of 1,050,000 shares of the Company’s common stock, par value $0.001 per share (the "Offering") (Filing, 8-K, Aprea, FEB 24, 2023, View Source [SID1234627685]). The price to the public in the Offering is $5.25 per share, before underwriting discounts and commissions. Under the terms of the Underwriting Agreement, the Company has granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 157,500 shares of common stock. The net proceeds to the Company from the Offering are expected to be approximately $4.8 million, after deducting underwriting discounts and commissions and estimated Offering expenses payable by the Company, assuming no exercise by the Underwriters of their option to purchase additional shares of common stock. The transactions contemplated by the Underwriting Agreement are expected to close on February 27, 2023, subject to the satisfaction of customary closing conditions.

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The Offering is being made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-250041) which became effective on November 30, 2020, as supplemented by a preliminary and final prospectus supplement thereunder, filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act").

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriter, including for liabilities under the Securities Act, other obligations of the parties and termination provisions. A copy of the Underwriting Agreement is filed as Exhibit 1.1 to this Current Report and is incorporated herein by reference. The foregoing description of the terms of the Underwriting Agreement is qualified in its entirety by the Underwriting Agreement.

The legal opinion, including the related consent, of DLA Piper LLP (US) relating to the legality of the issuance and sale of the shares of the Company’s common stock in the Offering is filed as Exhibit 5.1 to this Current Report.

This Current Report contains forward-looking statements that involve risk and uncertainties, such as statements related to the anticipated closing of the Offering and the amount of net proceeds expected from the Offering. The risks and uncertainties involved include the Company’s ability to satisfy certain conditions to closing on a timely basis or at all, as well as other risks detailed from time to time in the Company’s Securities and Exchange Commission filings.

CYTOKINETICS ANNOUNCES THREE UPCOMING PRESENTATIONS AT THE AMERICAN COLLEGE OF CARDIOLOGY 72ND ANNUAL SCIENTIFIC SESSION

On February 24, 2023 Cytokinetics, Incorporated (Nasdaq: CYTK) reported three poster presentations at the American College of Cardiology 72nd Annual Scientific Session (ACC.23) taking place in New Orleans, LA from March 4, 2023 – March 6, 2023 (Press release, Cytokinetics, FEB 24, 2023, View Source [SID1234627684]).

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Title: 1560-153 – Aficamten in Patients with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (REDWOOD-HCM Cohort 4)
Presenter: Ahmad Masri, M.D. M.S., Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University
Session: 1560 – Heart Failure and Cardiomyopathies: Clinical Science 11
Date: March 5, 2023
Presentation Time: 12:45 PM-1:30 PM Central Time
Location: Poster Hall, Hall F

Title: 1042-07 – Long-Term Efficacy and Safety of Aficamten in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy
Presenter: Sara Saberi, M.D., Associate Professor, Cardiovascular Medicine, Frankel Cardiovascular Center, University of Michigan Health
Session: 1042 – Bulking Up: New Research in Hypertrophic Cardiomyopathy
Date: March 5, 2023
Presentation Time: 9:45-9:55 AM Central Time
Location: Heart Failure and Cardiomyopathies Moderated Poster Theater 11, Hall F

Title: 1279-169 – Applicability of the GALACTIC-HF Trial and Omecamtiv Mecarbil to Patients Hospitalized for Heart Failure in the United States: From the GWTG-HF Registry
Presenter: Josephine Harrington, M.D., Fellow, Division of Cardiology, Duke Clinical Research Institute, Duke University School of Medicine
Session: 1279 – Heart Failure and Cardiomyopathies: Clinical Science 3
Date: March 4, 2023
Presentation Time: 11:45-12:30 PM Central Time
Location: Poster Hall, Hall F

TG Therapeutics to Host Conference Call on Fourth Quarter and Year-End 2022 Financial Results and Business Update

On February 24, 2023 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held on Tuesday, February 28, 2023 at 8:30 AM ET to discuss results for the fourth quarter and year-end 2022 and provide a business outlook for 2023. Michael S. Weiss, Chairman and Chief Executive Officer, will host the call (Press release, TG Therapeutics, FEB 24, 2023, https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-fourth-quarter-and-year-2 [SID1234627683]).

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In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Fourth Quarter and Year End 2021 Update Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

SELLAS Life Sciences Announces Pricing of $20.0 Million Underwritten Public Offering

On February 24, 2023 ELLAS 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 the pricing of its previously announced underwritten public offering of 7,220,217 shares of its common stock and accompanying warrants to purchase up to 7,220,217 shares of common stock at a combined public offering price of $2.77 per share and accompanying warrant (Press release, Sellas Life Sciences, FEB 24, 2023, View Source [SID1234627682]). The warrants to purchase shares of common stock have an exercise price of $2.77 per share, are immediately exercisable and will expire five years from the date of issuance. All of the securities in the offering will be sold by SELLAS, with gross proceeds to SELLAS expected to be $20.0 million before deducting underwriting discounts and commissions and offering expenses. The offering is expected to close on February 28, 2023, subject to the satisfaction of customary closing conditions.

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Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering. The public offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-255318) that was previously filed with the Securities and Exchange Commission (the "SEC") on April 16, 2021 and declared effective on April 29, 2021. A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, 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 will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.