On April 1, 2025, AIM ImmunoTech Inc., a Delaware corporation (the "Company") entered into an Equity Distribution Agreement (the "Sales Agreement") with Maxim Group LLC ("Maxim"), to sell shares of its common stock, par value $0.001 per share (the "Common Stock") for an aggregate offering price of up to $3,000,000 of Common Stock (the "Shares") from time to time, through an "at the market offering" program (the "ATM Offering") under which Maxim will act as an exclusive sales agent (Filing, 8-K, AIM ImmunoTech, APR 1, 2025, View Source [SID1234651802]). At the current time, the Company can only sell $663,329 due to the limitations of General Instruction I.B.6 of Form S-3.

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On April 1, 2025, the Company filed a universal shelf registration statement on Form S-3 (File No. 333286319) (the "Registration Statement") which includes a prospectus relating to the ATM Offering (the "Prospectus") with the Securities and Exchange Commission (the "SEC"). Once the SEC declares the Registration Statement effective, the Company will be able to offer and sell Shares in the ATM Offering under the Prospectus through Maxim pursuant to the Sales Agreement.

Sales of the Shares under the Sales Agreement may be made by any method that is deemed to be an "at the market" offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended ("Securities Act"), or by any other method permitted by law. Maxim will make all sales using commercially reasonable efforts consistent with its normal trading and sales practices. The compensation payable to the Maxim for sales of Shares pursuant to the Sales Agreement will be 3.0% of the gross proceeds for any Shares sold to or through Maxim. In addition, the Company has agreed to reimburse Maxim for certain expenses it incurs in the performance of its obligations up to a maximum of $50,000, and $5,000 per quarter thereafter, under the Sales Agreement. The Sales Agreement may be terminated by the Company or Maxim in accordance with the terms therein. The Company made certain customary representations, warranties and covenants concerning the Company and the Shares in the Sales Agreement and agreed to indemnify Maxim against certain liabilities, including liabilities under the Securities Act.

The Company has no obligation to sell any of the Shares, and may at any time suspend offers under the Sales Agreement. The ATM Offering will terminate upon the earlier of (i) the sale of Shares under the Distribution Agreement having an aggregate offering price of $3 million, 24 months from the date of the Sales Agreement or the termination of the Sales Agreement by either the Company or Maxim upon the provision of fifteen (15) days written notice. In addition, sales of Shares under the ATM Offering shall not exceed $3 million, unless and until the Company files an amended or new Prospectus Supplement.

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

The description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the Sales Agreement, which is filed as an exhibit hereto and incorporated herein by reference.

The legal opinion of Silverman Shin & Schneider PLLC relating to the Shares is filed as Exhibit 5.1 hereto and incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will 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 registration or qualification under the securities laws of any such state or other jurisdiction.

On April 1, 2025 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies, reported that company management will participate in the 24th Annual Needham Virtual Healthcare Conference (Press release, Cidara Therapeutics, APR 1, 2025, View Source [SID1234651714]).

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Details are as follows:

Event: 24th Annual Needham Virtual Healthcare Conference
Date: Wednesday, April 9, 2025
Time: 11:00 AM ET
Format: Presentation
Webcast: View Source

A replay of the presentation will be available in the Investors section on the Company’s website at www.cidara.com. The replay of the presentation will be available for 90 days.

Cidara will also participate in one-on-one investor meetings during this event. Investors interested in meeting with Cidara at the conference should contact their Needham representative directly.

On April 1, 2025 Shanghai Yingli Pharmaceutical Co., Ltd. (Yingli Pharma), a clinical stage biotechnology company developing oral small molecule drugs for cancer, metabolic, and immune diseases, reported that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global registration Phase 3 study of linperlisib versus physicians’ choice of standard of care for the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL) (Press release, Yingli Pharmaceutical, APR 1, 2025, View Source [SID1234651730]). FDA’s approval of the pivotal Phase 3 protocol follows a successful Type B End-of-Phase 2 meeting, during which Yingli Pharma discussed the overall development program and regulatory path. The Phase 3 study is planned to commence during the second quarter of 2025. Linperlisib is a potent oral small molecule inhibitor of the delta isoform of PI3 kinase (PI3Kδ) developed by Yingli Pharma.

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"This is a major milestone for linperlisib.", said Michael Hui, Chairman and Chief Executive Officer of Yingli Pharma, "We are very excited that linperlisib has entered the global pivotal study stage with the agreement from FDA. We will continue our mission to address patient unmet clinical needs globally and to accelerate the linperlisib clinical development program to bring more treatment options for patients with R/R PTCL."

In this Phase 3 study, linperlisib will be evaluated versus physicians’ choice of standard of care in R/R PTCL patients who have received one or more prior systemic therapies. The Phase 3 study will open enrollment in the U.S. and other countries.

About linperlisib
Linperlisib is a next-generation highly selective PI3Kδ inhibitor with a well-tolerated and differentiated safety profile as indicated from clinical trials in follicular lymphoma (FL), T-cell lymphoma and other hematologic and solid tumor studies. In November 2022, linperlisib was approved in China for the treatment of adult patients with R/R FL. Also in 2022, linperlisib received U.S. Food and Drug Administration (FDA) Orphan Drug Designations for FL, Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma and T-Cell Lymphoma. To date, over 6000 patients have been treated with linperlisib in clinical studies and post market approval with consistent and well-tolerated safety profile.

Linperlisib has been studied in three clinical trials in R/R PTCL in China, U.S. and Europe, with greater than 165 R/R PTCL patients treated. Collectively, these studies have demonstrated a high objective response rate, high complete response rate, promising progression free survival, overall survival, and a very manageable safety profile through the ongoing evaluations. Overall, Chinese, U.S. and European R/R PTCL patients have exhibited similar levels of efficacy and tolerability, establishing a strong foundation for a global registration trial.

On April 1, 2025 Domain Therapeutics ("Domain" or "the Company"), the GPCR experts harnessing deep receptor biology to develop breakthrough treatments for patients, reported that it will be presenting new preclinical and clinical data on its key oncology programs – DT-7012, and DT-9081, alongside preclinical findings on its PAR2 biased negative allosteric modulator ( NAM ) program – at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) ( AACR (Free AACR Whitepaper) ) Annual Meeting 2025, taking place in Chicago, US from 25-30 April 2025 (Press release, Domain Therapeutics, APR 1, 2025, View Source [SID1234651715]).

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The poster presentations will highlight Domain’s progress in leveraging GPCR-targeting therapies to modulate the tumor microenvironment and enhance anti-cancer immune responses.

Details of the poster presentations are as follows:

Poster Title: Comprehensive Characterization of DT-7012, a Differentiated CCR8-Depleting Antibody for the Treatment of Solid Tumors
Session Category: Experimental and Molecular Therapeutics
Session Title: Antireceptors and Other Biological Therapeutic Agents
Date and Time: Sunday 27th April 2025, 14:00 – 17:00 CDT
Location: Poster Section 15
Poster Board Number: 4
Abstract Number: 7080

DT-7012 – A Differentiated CCR8-Depleting Antibody for Solid Tumors

DT-7012 is a highly selective, fully humanized monoclonal antibody targeting CCR8, a receptor predominantly expressed on tumor-resident regulatory T cells ( Tregs ), which suppress anti-tumor immunity.
The study characterizes DT-7012’s binding properties, effector functions, and Treg-depleting activity, supporting its transition into clinical development.

Poster Title: Clinical PK, PD and safety analysis of a phase I clinical trial of DT-9081, an EP4R-antagonist, for RP2D determination in patients with advanced solid tumors
Session Category: Clinical Research
Session Title: Modifiers of the Tumor Microenvironment
Date and Time: Monday 28th April 2025, 14:00 – 17:00 CDT
Location: Poster Section 30
Poster Board Number: 8
Abstract Number: 7450

DT-9081 – Phase I Clinical Data of an EP4R Antagonist for Advanced Solid Tumors

DT-9081 is an oral EP4 receptor ( EP4R ) antagonist designed to inhibit growth by blocking prostaglandin E2 ( PGE2 )-mediated immune suppression. Interim Phase I results demonstrate DT-9081’s favorable safety profile, linear pharmacokinetics, and dose-dependent inhibition of EP4R signaling, with data supporting the recommended Phase II dose ( RP2D ).

Poster Title: PAR2 inhibitors reduce resistance to immunotherapy against cancer
Session Category: Immunology
Session Title: Interplay between Immune System and Radio-, Chemo- and Targeted Therapies 2
Date and Time: Tuesday 29th April, 14:00 – 17:00 CDT
Location: Poster Section 40
Poster Board Number: 9
Abstract Number: 6606

PAR2 – Pivotal driver of resistance to immune checkpoint blockade ( ICB ) and T cell dysfunction in cancer

PAR2 biased NAM represents a transformative breakthrough in immuno-oncology, targeting tumor resistance to ICB. Preclinical findings demonstrate the unique mode of action of PAR2 inhibition. By reshaping the tumor microenvironment, it reduces immunosuppressive macrophages and increases antigen presentation, fostering robust anti-tumor immune responses and thereby improving patient outcomes.

Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: "These promising preclinical and clinical results for DT-7012 and DT-9081, alongside the preclinical findings on our PAR2 biased NAM demonstrate Domain’s unmatched knowledge in leveraging deep receptor biology to develop differentiated oncology treatments. We look forward to sharing these promising insights with the scientific community as we continue to push the boundaries to ultimately deliver better treatments and transform patients’ lives."

Abstracts are available in an online itinerary planner found here and will be available in an online only supplement to the AACR (Free AACR Whitepaper) journal Cancer Research one month after the conference.

On April 1, 2025 Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported that it has entered into a definitive agreement for the purchase of 1,739,131 shares of its common stock (or pre-funded warrants in lieu thereof), at a purchase price of $1.15 per share (or pre-funded warrant in lieu thereof) (Press release, Citius Pharmaceuticals, APR 1, 2025, View Source [SID1234651731]). The closing of the offering is expected to occur on or about April 2, 2025, 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 aggregate gross proceeds to the Company from the offering are expected to be approximately $2 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering to support the commercial launch of LYMPHIR as well as general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-277319) filed with the Securities and Exchange Commission ("SEC") on February 23, 2024 and declared effective on March 1, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the 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 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 jurisdiction.