Merus Announces Pricing of Upsized Public Offering of Common Shares

On May 29, 2024 Merus N.V. (Nasdaq: MRUS) ("Merus", the "Company," "we" and "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the pricing of an upsized underwritten public offering of 7,550,000 common shares, at a public offering price of $53.00 per share (the "Offer Shares") (Press release, Merus, MAY 29, 2024, View Source [SID1234643803]). Merus also granted the underwriters a 30-day option to purchase up to an additional 1,132,500 common shares (the "Option Shares" and together with the Offer Shares, the "Shares"). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses and excluding the underwriters’ option to purchase the Option Shares, are expected to be approximately $400.2 million. All of the shares in the offering are to be sold by Merus.

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The offering is expected to close on or about May 31, 2024, subject to customary closing conditions.

Merus currently intends to use the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to advance the clinical development of its product candidates, for preclinical research and technology development, and for working capital and general corporate purposes.

Jefferies, BofA Securities, Leerink Partners, Guggenheim Securities and BMO Capital Markets are acting as joint book-running managers for the offering. Van Lanschot Kempen is acting as lead manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission (SEC) on February 28, 2024 and was effective upon filing. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, which, for the avoidance of doubt, will not constitute a "prospectus" for the purposes of (i) Regulation (EU) 2017/1129 (the "Prospectus Regulation") and has not been reviewed by any competent authority in any member state in the European Economic Area (the "EEA") and (ii) the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the "UK Prospectus Regulation") and has not been reviewed by the Financial Conduct Authority in the United Kingdom. A preliminary prospectus supplement to the prospectus describing the terms of the offering was filed with the SEC on May 28, 2024, and a final prospectus supplement will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; BofA Securities NC1-0220-02-25, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, NC 28255‐0001, or by email at [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 151 W 42nd Street, 32nd Floor, New York, NY 10036, by telephone at (800) 414-3627 or by email at: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities 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 registration or qualification under the securities laws of any such state or jurisdiction.

This press release is an advertisement and not a prospectus within the meaning of either the Prospectus Regulation or the UK Prospectus Regulation.

EEA:

In relation to each member state of the EEA (each, a "Relevant State"), no Shares have been offered or will be offered pursuant to the offering to the public in that Relevant State prior to the publication of a prospectus in relation to the Shares which has been approved by the competent authority in that Relevant State or, where appropriate, approved in another Relevant State and notified to the competent authority in that Relevant State, all in accordance with the Prospectus Regulation, except that Shares may be offered to the public in that Relevant State at any time:

to any legal entity which is a "qualified investor" as defined under Article 2 of the Prospectus Regulation;
to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; and
in any other circumstances falling within Article 1(4) of the Prospectus Regulation,
provided that no such offer of the Shares shall require us or any of the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation. Each person who initially acquires any Shares or to whom any offer is made will be deemed to have represented, warranted, acknowledged and agreed to and with us and each of the underwriters that it is a "qualified investor" within the meaning of Article 2 of the Prospectus Regulation.

For the purposes of the above, the expression "offer to the public" in relation to the Shares in any Relevant State means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase or subscribe for any Shares, and the expression "Prospectus Regulation" means Regulation (EU) 2017/1129.

United Kingdom:

No Shares have been offered or will be offered pursuant to this offering to the public in the United Kingdom prior to the publication of a prospectus in relation to the Shares which has been approved by the Financial Conduct Authority in the United Kingdom, except that the Shares may be offered to the public in the United Kingdom at any time:

a) to any legal entity which is a qualified investor as defined under Article 2 of the UK Prospectus Regulation;

b) to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the UK Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or

c) in any other circumstances falling within Section 86 of the Financial Services and Markets Act 2000 (the "FSMA")

provided that no such offer of the Shares shall require us or any of the underwriters to publish a prospectus pursuant to Section 85 of the FSMA or Article 3 of the UK Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the UK Prospectus Regulation. Each person in the United Kingdom who initially acquires any Shares or to whom any offer is made will be deemed to have represented, warranted, acknowledged and agreed to and with us and each of the underwriters that it is a "qualified investor" within the meaning of the UK Prospectus Regulation.

For the purposes of this provision, the expression an "offer to the public" in relation to the Shares in the United Kingdom means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase or subscribe for any Shares.

In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with persons who are "qualified investors" (as defined in the UK Prospectus Regulation) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the FSMA (Financial Promotion) Order 2005, as amended (the Order), and/or (ii) who are high net worth entities (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). In the United Kingdom, the securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person in the United Kingdom who is not a relevant person should not act or rely on this communication or any of its contents.

Rakuten Medical to Host R&D Day Highlighting Recent Interim Data from Phase 1b/2 Clinical Trial of ASP-1929 Photoimmunotherapy in Combination with anti-PD-1 in r/m HNSCC

On May 29, 2024 Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy based on its proprietary Alluminox platform, reported that it will host a virtual R&D Day on Thursday, June 20, 2024 at 1:00 pm ET / 10:00 am PT (Press release, Rakuten Medical, MAY 29, 2024, View Source [SID1234643820]).

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The event will feature a key opinion leader, Dr. Ann M. Gillenwater, Professor, Department of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center, who will discuss the updated safety and efficacy findings from an interim evaluation of Rakuten Medical’s open-label Phase 1b/2 study (ASP-1929-181/ClinicalTrials.gov Identifier: NCT04305795) of photoimmunotherapy using ASP-1929 in combination with anti-PD-1 therapy in first line recurrent and/or metastatic head and neck squamous cell carcinoma, which will be presented in a poster at ASCO (Free ASCO Whitepaper) 2024.

Rakuten Medical’s executive management team will provide other key clinical and business updates including, but not limited to, development programs including a new study and Japan commercial updates.

A live question and answer session will follow the formal presentation.

Please note that practicing healthcare professionals and patients are not permitted to attend.

R&D Day event site: R&D Day event site: View Source

Alkermes to Participate in Two Upcoming Investor Conferences

On May 29, 2024 Alkermes plc (Nasdaq: ALKS) reported that management will participate in fireside chat presentations at two upcoming investor conferences (Press release, Alkermes, MAY 29, 2024, View Source [SID1234643770]).

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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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Jefferies Healthcare Conference
Date/Time: Thursday, June 6, 2024 at 1:30 p.m. EDT (6:30 p.m. BST)

Goldman Sachs 45th Annual Global Healthcare Conference
Date/Time: Tuesday, June 11, 2024 at 10:40 a.m. EDT (3:40 p.m. BST)

The live webcasts may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

IGM Biosciences to Present at the Jefferies Healthcare Conference

On May 29, 2024 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported that Fred Schwarzer, Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Wednesday, June 5, 2024, at 2:30 p.m. EDT in New York (Press release, IGM Biosciences, MAY 29, 2024, View Source [SID1234643788]).

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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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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

AFFIMED RECEIVES FAST TRACK DESIGNATION FOR COMBINATION THERAPY OF AFM24 WITH ATEZOLIZUMAB FOR EGFR WILD-TYPE NON-SMALL CELL LUNG CANCER

On May 29, 2024 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that the FDA has granted Fast Track designation to the combination of its innate cell engager (ICE) AFM24 with atezolizumab for the treatment of patients with advanced and/or metastatic non-small cell lung cancer (NSCLC) not harboring any activating EGFR mutations (EGFR wild-type) after progression on PD-(L)1 targeted therapy and platinum-based chemotherapy (Press release, Affimed, MAY 29, 2024, View Source [SID1234643804]). Data from the AFM24-102 study in this patient population will be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 1, 2024.

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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 clinical data of AFM24 in combination with the checkpoint inhibitor atezolizumab is compelling. We’re observing meaningful responses in patients resistant to prior checkpoint inhibitor treatment," said Dr. Wolfgang Fischer, Chief Operating Officer at Affimed. "The Fast Track designation emphasizes the belief in the potential of this combination therapy to address currently unmet needs of patients with this devastating, life threatening disease who have exhausted all standard of care options, including chemotherapy and checkpoint inhibitors."

Fast Track is a process designed to facilitate the development and expedite the review of new drugs that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. The FDA’s decision is based on initial activity observed in the first evaluable patients of the phase 2 part of the AFM24-102 study of AFM24 in combination with atezolizumab in heavily pretreated patients with NSCLC EGFRwt. With the Fast Track designation, the therapeutic development of the combination can benefit from more frequent engagement with the FDA, which will support the collection of appropriate data needed to accelerate its development.

About FDA Fast Track Designation

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Its purpose is to get important new drugs to patients earlier. Fast Track addresses a broad range of serious conditions. With Fast Track designation, a new therapy is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
Please refer to Fast Track | FDA for further information.

Conference Call and Webcast Information

Affimed will host a conference call and webcast for the financial community on June 1, 2024, at 6:00 p.m. CDT / 7:00 p.m. EDT. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use link:

https://register.vevent.com/register/BIff607338e5d247f99b548240be2ad413, and you will be provided with dial-in details and a pin number.

About AFM24
AFM24 is a tetravalent, bispecific ICE that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.