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.

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

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.

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.

On February 24, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo (cemiplimab) in combination with platinum-based chemotherapy (Press release, Regeneron, FEB 24, 2023, View Source [SID1234627681]). Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.

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The European Commission is expected to make a final decision on the application in the coming months. In November 2022, the Libtayo combination was approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression.

The positive opinion is supported by results from the global Phase 3 EMPOWER-Lung 3 trial, which was designed to closely resemble a patient population with varied disease presentations that physicians manage in everyday clinical practice. At the primary analysis with a median follow-up of 16 months, the trial showed a statistically significant improvement in overall survival (OS) for patients treated with the Libtayo combination (n=312) compared to chemotherapy alone (n=154) in the overall population (hazard ratio [HR]: 0.71; 95% confidence interval [CI]: 0.53 to 0.93).

Among the 466 patients enrolled in the trial, 70% of patients (n=327) had tumors expressing PD-L1 ≥1%. Comparing the Libtayo combination (n=217) to chemotherapy alone (n=110), efficacy results in this population showed a:

22-month versus 13-month median OS with a median follow-up of 16 months. This represented a 45% relative reduction in the risk of death in the trial (HR: 0.55; 95% CI: 0.39 to 0.78).
Continued clinically meaningful survival benefit with a median duration of follow-up of 28 months (HR: 0.51; 95% CI: 0.38 to 0.69).
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo. Among those measured for safety in the trial (n=465), adverse reactions occurring in at least 10% of patients included anemia (44%), alopecia (37%), musculoskeletal pain (27%), nausea (25%), fatigue (23%), peripheral neuropathy (21%), hyperglycemia (18%), decreased appetite (17%), alanine aminotransferase increased (16%), aspartate aminotransferase increased (15%), neutropenia (15%), constipation (14%), dyspnoea (13%), rash (13%), thrombocytopenia (13%), vomiting (12%), diarrhea (11%), insomnia (11%), weight decreased (11%) and hypoalbuminemia (10%). Adverse events were serious in 25% of patients and led to permanent discontinuation of Libtayo in 5% of patients.

Libtayo is currently approved in the EU and other countries for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), advanced NSCLC and advanced cervical cancer.

About the Phase 3 Trial
EMPOWER-Lung 3 was a randomized, multicenter Phase 3 trial investigating Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy, compared to platinum-doublet chemotherapy alone. The trial enrolled 466 patients with locally advanced or metastatic NSCLC, as well as squamous or non-squamous histologies across all PD-L1 expression levels and with no ALK, EGFR or ROS1 aberrations.

Among those enrolled, 43% had tumors with squamous histology, 15% had locally advanced disease, and 7% had a history of brain metastases. Patients were randomized 2:1 to receive either Libtayo or placebo, plus histology-specific platinum-doublet chemotherapy. The trial was stopped early based on a recommendation by the Independent Data Monitoring Committee (IDMC) after the Libtayo and chemotherapy combination demonstrated a significant improvement in overall survival, the primary endpoint. Results of the trial at the primary endpoint were published in Nature Medicine in August 2022.

In December 2022, Libtayo in combination with chemotherapy was added to the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale (score: 4 out of 5), for patients with advanced NSCLC across squamous and non-squamous histologies, and irrespective of PD-1 expression levels.

About NSCLC
Lung cancer is the leading cause of cancer death worldwide. In recent years, more than 2.2 million annual new cases have been diagnosed globally. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages. Additionally, 70% of all NSCLC cases will have <50% PD-L1 expression, making it the most common treatment setting.