Alkermes to Participate in the 24th Annual Needham Virtual Healthcare Conference

On April 2, 2025 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a webcast panel discussion "Development of Orexin Receptor Agonist in Sleep-Wake Disorders" at the upcoming 24th Annual Needham Virtual Healthcare Conference on Wednesday, April 9, 2025 at 11:45 a.m. EDT (4:45 p.m. BST) (Press release, Alkermes, APR 2, 2025, View Source [SID1234651746]). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!


Entry into a Material Definitive Agreement

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Mersana Therapeutics Announces Upcoming Oral Presentation of Emi-Le Clinical Data at European Society for Medical Oncology (ESMO) Breast Cancer 2025 Annual Congress

On April 2, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that Phase 1 dose escalation and backfill cohort clinical data for emiltatug ledadotin (Emi-Le; XMT-1660) will be presented in an oral session at the ESMO (Free ESMO Whitepaper) Breast Cancer 2025 Annual Congress, which is being held from May 14-17, 2025, in Munich, Germany (Press release, Mersana Therapeutics, APR 1, 2025, View Source [SID1234651761]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Oral Presentation Details

Title: Clinical Activity of Emiltatug Ledadotin (Emi-Le), a B7-H4-Directed ADC, in Patients with TNBC who Received at Least One Prior Topoisomerase-1 Inhibitor (Topo-1) ADC

Session Title: Mini Oral Session 1

Date and Time: Thursday, May 15, 2025 from 8:30-10:00 a.m. CEST

Abstract Number: 298MO

Presenter: Erika Hamilton, M.D., Director Breast Cancer Research, Sarah Cannon Research Institute in Nashville, Tennessee

About Emi-Le
Emi-Le is a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin payload with controlled bystander effect. This candidate is being investigated in a Phase 1 dose escalation and expansion trial in patients with solid tumors, including breast, endometrial and ovarian cancers as well as adenoid cystic carcinoma type 1. In the initial clinical data that were reported as of a December 13, 2024 data cutoff, Emi-Le was observed to be generally well tolerated with differentiated safety and tolerability profile. Additionally, confirmed objective responses were observed across all enrolled tumor types, including in patients with triple negative breast cancer (TNBC) who had previously been treated with a topoisomerase-1 inhibitor (topo-1) ADC.

The U.S. Food and Drug Administration has granted two Fast Track designations to Emi-Le for the treatment of 1) adult patients with advanced or metastatic triple-negative breast cancer, and 2) advanced or metastatic breast cancer in patients with human epidermal growth factor receptor 2 (HER2) low (IHC 1+ or IHC 2+/ISH–) or HER2-negative (IHC 0) disease, including TNBC, who have received a prior topo-1 ADC. For more information about Mersana’s ongoing Phase 1 trial of Emi-Le, please visit clinicaltrials.gov (NCT05377996).

Entry into a Material Definitive Agreement

On April 1, 2025 Citius Pharmaceuticals, Inc. (the "Company") entered into a securities purchase agreement (the "Purchase Agreement") with a certain institutional investor for the issuance and sale, in a registered direct offering by the Company (the "Offering"), of 465,000 shares of the Company’s common stock, par value $0.001 per share (the "Shares"), and pre-funded warrants to purchase up to 1,274,131 shares of common stock (the "Pre-funded Warrants") at an offering price of $1.15 and $1.1499, respectively (Filing, 8-K, Citius Pharmaceuticals, APR 1, 2025, View Source [SID1234651752]). The Offering closed on April 2, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Pre-funded Warrants are exercisable immediately at an exercise price of $0.0001 per share and shall remain valid and exercisable until all the Pre-funded Warrants are exercised in full. A holder of a Pre-funded Warrant will not have the right to exercise any portion of its warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or 9.99% at the election of the holder prior to the date of issuance) of the number of shares of common stock outstanding immediately after giving effect to such exercise (the "Beneficial Ownership Limitation"); provided, however, that upon 61 days’ prior notice to the Company, the holder may increase or decrease the Beneficial Ownership Limitation, provided that in no event shall the Beneficial Ownership Limitation exceed 9.99%. The exercise price and number of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the common stock and the exercise price.

H.C. Wainwright and Co., LLC ("Wainwright") acted as the Company’s exclusive placement agent in connection with the Offering. In connection with the Offering, the Company agreed to pay Wainwright a cash fee of 7.0% of the gross proceeds the Company received in the Offering. The Company agreed to also reimburse Wainwright up to $25,000 for fees and expenses of legal counsel, $10,000 for non-accountable expenses and $10,000 for a clearing fee. In addition, the Company granted placement agent warrants to Wainwright, or its designees, to purchase up to 121,739 shares of the common stock (the "Placement Agent Warrants").

The Placement Agent Warrants have an exercise price equal to $1.4375 per share, are exercisable six months after issuance and will expire five years from the commencement of sales in the Offering. The exercise price and number of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the common stock and the exercise price. If there is no effective registration statement for the resale of the shares issuable upon exercise of the Placement Agent Warrants, holders of the Placement Agent Warrants may elect a "cashless" exercise, whereby they would receive the net number of shares of common stock determined according to a formula set forth in the Placement Agent Warrants. On the expiration date of the Placement Agent Warrants, any Placement Agent Warrants outstanding and unexercised will be automatically exercised via cashless exercise.

The net proceeds to the Company from the Offering were approximately $1.735 million, after deducting placement agent fees and other offering expenses payable by the Company. The Company anticipates using the net proceeds to support the commercial launch of LYMPHIR and general corporate purposes.

Pursuant to the Purchase Agreement, the Company agreed for a period of 30 days following the closing of the Offering not to issue, enter into an agreement to issue or announce the issuance or proposed issuance of the shares or any other securities convertible into, or exercisable or exchangeable for, shares of common stock, subject to certain exceptions.

The Offering was made pursuant to the Company’s effective registration statement on Form S-3 (File No. 333-277319), which was previously declared effective by the Securities and Exchange Commission (the "SEC") on March 1, 2024, including a prospectus supplement filed with the SEC on April 1, 2025.

The Purchase Agreement contains customary representations and warranties and agreements of the Company and the investors and customary indemnification rights and obligations of the parties. The representations, warranties and covenants contained in the Purchase Agreement were made solely for the benefit of the parties to the Purchase Agreement and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Purchase Agreement, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the SEC.

The foregoing descriptions of the Purchase Agreement, the Pre-funded Warrants and the Placement Agent Warrants are qualified in their entirety by reference to the forms of the Purchase Agreement, the Pre-funded Warrants and the Placement Agent Warrants, copies of which are attached hereto as Exhibits 10.1, 4.1 and 4.2, respectively, and are incorporated herein by reference. A copy of the opinion of Wyrick Robbins Yates & Ponton LLP relating to the legality of the issuance and sale of the Shares, the Pre-funded Warrants and the Placement Agent Warrants in the Offering is attached as Exhibit 5.1 hereto.

enGene to Present at the Stifel 2025 Virtual Targeted Oncology Forum

On April 1, 2025 enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that Ron Cooper, Chief Executive Officer, will present at the Stifel 2025 Virtual Targeted Oncology Forum, on Tuesday, April 8, 2025, at 4:00 p.m. ET (Press release, enGene, APR 1, 2025, View Source [SID1234651738]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation can be accessed under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.