On April 1, 2025 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in a fireside chat at the 24th Annual Needham Virtual Healthcare Conference on Tuesday, April 8, at 12:45 p.m. ET (Press release, Bicycle Therapeutics, APR 1, 2025, View Source [SID1234651712]).

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A live webcast of the fireside chat will be accessible from the Investor section of the company’s website at www.bicycletherapeutics.com. A replay of the webcast will be archived and available following the event.

On April 1, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company with two programs in clinical-stage development, reported the departure of Dr. Brendan Eckelman, co-founder and Chief Scientific Officer (CSO) and the appointments of Dr. Carlos Bais and David Matly to CSO and President, respectively (Press release, Inhibrx, APR 1, 2025, View Source [SID1234651729]).

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Dr. Eckelman leaves the Company to establish a newly-formed private biotechnology company, where he will be founder and Chief Executive Officer. Inhibrx and the new company have entered into an exclusive license agreement for the rights to certain technologies no longer being pursued by Inhibrx. The agreement includes an upfront payment upon completion of the initial funding of Dr. Eckelman’s new company and other future development milestones.

"I would like to express my deep gratitude to Brendan for his extraordinary contributions to Inhibrx over the last 15 years," said Mark Lappe, CEO of Inhibrx. "Brendan has had a profound impact on Inhibrx and we expect he will lead this next endeavor to the same success."

"I am immensely proud of the achievements and groundbreaking innovations we have developed since co-founding Inhibrx in 2010. As I announce my departure, it is a bittersweet moment.," says Dr. Eckelman. "I have the utmost confidence in the team and the culture of innovation I’m leaving behind and look forward to continuing to support Inhibrx in my capacity as a shareholder."

Dr. Carlos Bais, the Company’s current Executive Vice President of Translational Sciences, will be appointed to CSO following Dr. Eckelman’s departure.

Additionally, the Company also announced the promotion of David Matly to President in addition to his existing roles as Chief Commercial and Business Development Officer. In David’s new role as President, he will continue to lead the commercial and business development functions as well as oversee clinical development and operations, R&D, technical operations and regulatory affairs. Notably, David played a key leadership role in Inhibrx, Inc.’s asset sale of INBRX-101 to Sanofi for up to $2.2B in 2024.

"We believe we are exceptionally well-positioned for continued success as Carlos steps into the role of CSO and David into the role of President," continued Mr. Lappe. "Carlos’s strong scientific background and expertise in late-stage development make him a perfect candidate to assume the CSO role. And David’s cross-functional understanding of successfully delivering best-in-class new therapies, combined with his ambition and commitment to the Company will prove to be pivotal to our future success. Each will play a crucial role as we continue to execute on our clinical programs in an effort to deliver significant impact to patients while maximizing the value to our shareholders."

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.