C4 Therapeutics to Participate in the Stifel 2023 Virtual Targeted Oncology Days

On April 19, 2023 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that C4T management will participate in a fireside chat at the Stifel 2023 Virtual Targeted Oncology Days (Press release, C4 Therapeutics, APR 19, 2023, View Source [SID1234630299]).

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Fireside Chat Details:
Event: Stifel 2023 Virtual Targeted Oncology Days
Date/Time: Wednesday, April 26th, 2023 at 11:00 AM ET

A live webcast will be available on the Investors section of the company’s website at www.c4therapeutics.com. An archived replay of the webcast will be available for approximately 30 days following the live event.

Alkermes to Report First Quarter Financial Results on April 26, 2023

On April 19, 2023 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, April 26, 2023 to discuss the company’s first quarter financial results (Press release, Alkermes, APR 19, 2023, View Source [SID1234630298]).

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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 webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. A replay of the webcast will be available approximately two hours after the completion of the event and may be accessed by visiting Alkermes’ website.

BioCryst to Report First Quarter 2023 Financial Results on May 3

On April 19, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will present its first quarter 2023 financial results on Wednesday, May 3, 2023 (Press release, BioCryst Pharmaceuticals, APR 19, 2023, View Source [SID1234630297]).

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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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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 1-866-777-2509 for domestic callers and 1-412-317-5413 for international callers. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com.

Bicara Therapeutics Announces Publication in Cancer Research Describing Design and Characterization of Lead Bifunctional Antibody Program, BCA101

On April 19, 2023 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics to elicit a potent and durable immune response, reported the publication of a manuscript in Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), describing the design and characterization of its lead program, BCA101, a first in class dual-action bifunctional antibody designed to inhibit EGFR and disable TGF-β directly at the tumor site (Press release, Bicara Therapeutics, APR 19, 2023, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-announces-publication-in-cancer-research-describing-design-and-characterization-of-lead-bifunctional-antibody-program-bca101 [SID1234630296]).

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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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"Over the last two decades, targeting EGFR alone has demonstrated variable clinical success while targeting TGF-β independently has shown limited clinical benefit. The bifunctional antibody fusion design of BCA101 provides a unique approach to addressing the complexities of the tumor microenvironment in EGFR expressing tumors. The data to date show that BCA101 inhibits EGFR and neutralizes TGF-β simultaneously to induce immune activation and suppress tumor growth," said senior author Pradip Nair, Associate Research Director at Syngene International. "Our findings suggest that the dual action of BCA101 may potentially offer improved clinical efficacy and a superior safety profile compared to current approaches that separately inhibit EGFR and sequester TGF-β."

The manuscript describes the important roles of the EGFR and TGF-β signaling pathways as mediators of tumorigenesis, and how the crosstalk between them contributes to cancer progression and drug resistance. The authors detail how BCA101, an anti-EGFR IgG1 monoclonal antibody linked to the extracellular domain of human TGF-β receptor II, is able to bind EGFR, inhibit tumor proliferation, while functionally neutralizing TGF-β and restoring the cytolytic activity of the local immune cells. Data suggest that BCA101 has a potential advantage over EGFR inhibitors, such as cetuximab, in activating the immune cells within the tumor microenvironment known to be suppressed by the presence of TGF-β. In addition, BCA101 in combination with anti-PD1, further improved tumor inhibition in both EGFR-expressing mouse models and humanized mice bearing PC-3 xenografts. Taken together, these data suggest that BCA101 may exert superior anti-tumor effects as a monotherapy, and in combination, by targeting both EGFR and TGF-β simultaniously.

"Based on these findings, we are working to rapidly advance BCA101 through the clinic because we believe this therapy can be very impactful across multiple tumor types in patients who both express EGFR and have elevated levels of TGF-β," said Rachel Salazar, SVP of R&D Strategy and Operations at Bicara Therapeutics.

Bicara has previously reported promising clinical data from its ongoing Phase 1/1b study of BCA101 in head and neck cancer, including efficacy as both a monotherapy and in combination with pembrolizumab. Preclinical data, also being presented today at the 2023 AACR (Free AACR Whitepaper) Annual Meeting further support BCA101’s mechanism of action and provide evidence of its potential to induce durable anti-tumor responses in various tumor types.

The paper, entitled "BCA101 is a tumor-targeted bifunctional fusion antibody that simultaneously inhibits EGFR and TGF-β signaling to durably suppress tumor growth," is published online today and can be accessed here.

Entry into a Material Definitive Agreement

On April 19, 2023, AIM Immunotech Inc. (the "Company") reported to have entered into an Equity Distribution Agreement (the "Distribution Agreement"), with Maxim Group LLC ("Maxim"), pursuant to which the Company may sell from time to time, shares of its common stock, $0.001 par value per share, having an aggregate offering price of up to $8.5 million (the "Shares") through Maxim, as agent (the "Offering") (Press release, AIM ImmunoTech, APR 19, 2023, View Source [SID1234630295]). On April 19, 2023, the Company filed a prospectus supplement with the Securities and Exchange Commission (the "SEC") in connection with the Offering (the "Prospectus Supplement") under its existing Registration Statement on Form S-3 (File No 333-262280), which became effective on February 4, 2023 (the "Registration Statement"), related to the sale of Shares having an aggregate offering price of up to $100 million.

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Subject to the terms and conditions of the Distribution Agreement, Maxim will use its commercially reasonable efforts to sell the Shares from time to time, based on the Company’s instructions. Under the Distribution Agreement, Maxim may sell the Shares by any method permitted by law deemed to be an "at-the-market" offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including, without limitation, sales made directly on the NYSE American.

The Company has no obligation to sell any of the Shares, and may at any time suspend offers under the Distribution Agreement. The Offering will terminate upon the earlier of (i) the sale of Shares under the Distribution Agreement having an aggregate offering price of $8.5 million, 24 months from the date of the Distribution Agreement or the termination of the Distribution Agreement by either the Company or Maxim upon the provision of fifteen (15) days written notice. In addition, sales of Shares under the Offering shall not exceed $8.5 million, unless and until the Company files an amended or new Prospectus Supplement.

Under the terms of the Distribution Agreement, Maxim will be entitled to a transaction fee at a fixed rate of 3.0% of the gross sales price of Shares sold under the Distribution Agreement. The Company will also reimburse Maxim for certain expenses incurred in connection with the Distribution Agreement, and has agreed to provide indemnification and contribution to Maxim with respect to certain liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended.

The Company intends to use the net proceeds from the sale of Shares for working capital and general corporate purposes.

The foregoing description of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Distribution Agreement, a copy of which is filed hereto as Exhibit 10.1. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there by any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

The Distribution Agreement and the above description have been included to provide investors and security holders with information regarding the terms of the Distribution Agreement. They are not intended to provide any other factual information about the Company or its subsidiaries, affiliates or stockholders. The representations, warranties and covenants contained in the Distribution Agreement were made only for purposes of the Distribution Agreement and as of specific dates; were solely for the benefit of the parties to the Distribution Agreement; and may be subject to limitations agreed upon by the parties, including being qualified by confidential disclosures made by each contracting party to the other for the purposes of allocating contractual risk between them that differ from those applicable to investors. Investors should not rely on the representations, warranties and covenants or any description thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries, affiliates, businesses or stockholders. Moreover, information concerning the subject matter of the representations, warranties and covenants may change after the date of the Distribution Agreement, which subsequent information may or may not be fully reflected in public disclosures or statements by the Company. Accordingly, investors should read the representations and warranties in the Distribution Agreement not in isolation but only in conjunction with the other information about the Company and its subsidiaries that the Company includes in reports, statements and other filings made with the SEC.

Silverman Shin & Byrne PLLC, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of this legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

Any Shares offered and sold in the Offering will be issued pursuant to the Company’s Registration Statement, the prospectus and the Prospectus Supplement relating to the Offering.