Mersana Therapeutics to Present at Bank of America Securities 2023 Healthcare Conference

On May 3, 2023 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 members of management will present at the Bank of America Securities 2023 Healthcare Conference on Wednesday, May 10, 2023 at 12:20 p.m. Eastern Time (Press release, Mersana Therapeutics, MAY 3, 2023, View Source [SID1234630932]).

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A live webcast of this event will be available on the Investors & Media section of Mersana’s website at www.mersana.com. An archived replay will be available for approximately 90 days following the event.

Merck to Participate in Bank of America Securities 2023 Healthcare Conference

On May 3, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Caroline Litchfield, executive vice president and chief financial officer, is scheduled to participate in a fireside chat at the Bank of America Securities 2023 Healthcare Conference on Wednesday, May 10, 2023, at 8:40 a.m. PDT / 11:40 a.m. EDT (Press release, Merck & Co, MAY 3, 2023, View Source [SID1234630931]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

Magenta Therapeutics and Dianthus Therapeutics Announce Merger Agreement

On May 3, 2023 Magenta Therapeutics, Inc. (Nasdaq: MGTA) ("Magenta") and Dianthus Therapeutics, Inc. ("Dianthus"), a privately-held, clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics, reported that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction (Press release, Magenta Therapeutics, MAY 3, 2023, View Sourcenews-releases/news-release-details/magenta-therapeutics-and-dianthus-therapeutics-announce-merger" target="_blank" title="View Sourcenews-releases/news-release-details/magenta-therapeutics-and-dianthus-therapeutics-announce-merger" rel="nofollow">View Source [SID1234630930]). The combined company will focus on advancing Dianthus’ pipeline of next-generation complement inhibitors, including DNTH103 currently in a Phase 1 clinical trial. Upon completion of the merger, the combined company is expected to operate under the name Dianthus Therapeutics, Inc. and trade on the Nasdaq under the ticker symbol "DNTH".

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In support of the merger, Dianthus has secured commitments for a $70 million private investment in its common stock and pre-funded warrants from a syndicate of healthcare investors led by Fidelity Management & Research Company, Catalio Capital Management, 5AM Ventures, Avidity Partners, Wedbush Healthcare Partners and founding investors Fairmount, Tellus BioVentures and Venrock Healthcare Capital Partners, that is expected to close immediately prior to completion of the merger. With the cash expected from both companies at closing and the proceeds of the concurrent private financing, the combined company is expected to have approximately $180 million of cash or cash equivalents immediately post-closing. The cash resources are intended to be used to advance Dianthus’ pipeline through multiple clinical data catalysts and is expected to fund operations into mid-2026. The merger and related financing are expected to close in the third quarter of 2023.

"I’m delighted to announce this planned merger with Magenta, which comes at a pivotal moment in the evolution of our company as we advance our pipeline of next-generation complement therapeutics for people living with severe autoimmune diseases," said Marino Garcia, President and Chief Executive Officer of Dianthus Therapeutics. "Gaining access to the public capital markets can enhance our financial strength and fuel our growth strategy, enabling us to unlock the full potential of our pipeline, including our plans to address multiple autoimmune disorders with our clinical-stage active C1s inhibitor, DNTH103."

"After a thorough exploration of our strategic alternatives, management and our Board of Directors believe the transaction with Dianthus Therapeutics will culminate in a successful outcome for our stockholders," said Steve Mahoney, President, Chief Financial and Operating Officer of Magenta. "Dianthus has made rapid progress in developing and advancing DNTH103 into the clinic where it has the potential to be a transformative classical pathway inhibitor for severe autoimmune diseases. We are extremely grateful to our current and former employees who contributed to Magenta’s efforts to develop its programs and we now look forward to the combined company’s advancement on opportunities for value creation for patients."

Magenta previously announced a comprehensive review of strategic alternatives in February 2023 and has since completed winding down a majority of its activities and costs associated with its research and development initiatives, including the termination of its lease and the sale of key assets.

About DNTH103
DNTH103 is an investigational long-acting classical complement pathway inhibitor designed as a less frequent and convenient subcutaneous injection with the potential to treat people living with severe autoimmune diseases. DNTH103, a fully human monoclonal antibody, is designed to selectively target only the active form of the C1s complement protein, inhibiting only the classical complement pathway, with the aim of treating patients with a lower dosing volume as a convenient subcutaneous injection suitable for a self-administered pre-filled pen. Inhibiting the active form of the complement target seeks to address a critical treatment gap in current complement therapies that do not bind selectively to the active protein, wasting a significant amount of the drug on inert proteins. DNTH103 selective inhibition of the classical pathway is engineered to preserve important immune activity of the lectin and alternative complement pathways needed to protect the body against infections from encapsulated bacteria. DNTH103 is also enhanced with YTE half-life extension technology to further reduce dosing frequency.

DNTH103 has a steady cadence of clinical milestones including top-line Phase 1 data aiming to confirm potent classical pathway inhibition and favorable, extended pharmacokinetics expected by the end of 2023, initiation of a Phase 2 trial in generalized Myasthenia Gravis expected in the first quarter of 2024 followed by two additional planned Phase 2 trial initiations in other neuro indications, and planned initiation of an open label proof of efficacy trial in Cold Agglutinin Disease with patient data anticipated in the second half of 2024.

About the Proposed Transaction, Management and Organization
Pre-merger Dianthus stockholders (including Dianthus stockholders issued shares of Dianthus common stock and pre-funded warrants in the concurrent private financing) are expected to own approximately 78.7% of the combined company and pre-merger Magenta stockholders are expected to own approximately 21.3% of the combined company. The percentage of the combined company that Magenta’s stockholders will own as of the close of the transaction is subject to adjustment based on the amount of Magenta’s net cash at the closing date. Immediately prior to the closing of the proposed merger, Magenta stockholders will be issued contingent value rights representing the right to receive certain payments from proceeds received by the combined company, if any, related to pre-transaction legacy assets.

Following the merger, the combined company will be led by Marino Garcia, the current CEO and President of Dianthus Therapeutics, and the current members of the Dianthus management team. Magenta Therapeutics, Inc. will be renamed "Dianthus Therapeutics, Inc." and the corporate headquarters will be co-located in New York, NY and Waltham, MA. The merger agreement provides that the Board of Directors of the combined company will be composed of eight board members, including all six current Dianthus board members and two from Magenta. The transaction has been unanimously approved by the Board of Directors of each company and is expected to close in the third quarter of 2023, subject to customary closing conditions, including, the approvals by the stockholders of each company and other customary closing conditions.

Wedbush PacGrow is serving as lead financial advisor, Houlihan Lokey Financial Advisors is serving as co-financial adviser and Goodwin Procter LLP is serving as legal counsel to Magenta Therapeutics. Jefferies, Evercore ISI, Guggenheim Securities and Raymond James are serving as the placement agents to Dianthus Therapeutics, and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Dianthus Therapeutics.

Webcast Presentation
The companies will host a webcast presentation to discuss the proposed transaction as well as Dianthus’ platform and pipeline assets today, May 3, 2023, at 8:30 a.m. ET. The live webcast can be accessed on the Events & Presentations page of Magenta’s website or by using the participant webcast link. A webcast of the presentation and associated slides will be available on the Investors & Media section of Magenta’s website at View Source and a replay will be archived for one year following the presentation.

Karyopharm Announces Presentation of Interim Data from Phase 2 Study of Single-Agent Eltanexor in Relapsed/Refractory (R/R) Higher-Risk Myelodysplastic Neoplasms (MDS) at 17th International Congress on MDS

On May 3, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported interim data from the Phase 2 portion of the open-label Phase 1/2 study of single-agent eltanexor in patients with higher R/R myelodysplastic neoplasms (Press release, Karyopharm, MAY 3, 2023, View Source [SID1234630928]). The data, featured in a poster presentation at the 17th International Congress on Myelodysplastic Syndromes, showed that eltanexor has promising single-agent efficacy with a generally manageable safety profile.

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As of the February 8, 2023 data cut-off date, 30 patients had been treated with 10mg eltanexor, oral, on Days 1-5 of each week. Eltanexor demonstrated a 27% overall response rate (ORR) in the intent-to-treat (ITT) population and a 31% ORR in the efficacy evaluable population. Median overall survival (mOS) was 8.7 months in both populations. Transfusion independence rate for red blood cells and/or platelets was 29%.

Eltanexor was generally well-tolerated and manageable. The most common adverse events (AEs) were asthenia (47%), diarrhea (43%), and nausea (33%), the majority of which were Grade 1-2. The most common Grade ≥3 treatment-emergent AEs were neutropenia (30%), thrombocytopenia (26.7%), and asthenia (16.7%).

"Existing first-line treatments for higher risk MDS are not typically curative; approximately half of these patients do not respond. Upon progression, median overall survival for these higher risk, relapsed or refractory MDS patients is approximately four to six months. There is a critical need for novel and more effective treatment options for this patient population," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "We are encouraged by the improved overall survival observed to date with eltanexor in this higher risk patient population. These preliminary results are promising and reinforce the potential of XPO1 inhibition to provide meaningful clinical benefit to patients with relapsed/refractory myelodysplastic neoplasms."

Approximately 12,000 to 20,000 people in the United States are diagnosed with MDS each year, with an estimated 87,000 new cases each year worldwide3. HMAs are the current standard of care for newly diagnosed, higher risk MDS patients, who are not candidates for transplant. However, only about 50% of patients respond, with these responses typically lasting less than two years.4 The prognosis of higher risk relapsed/refractory disease is poor, with a median overall survival of four to six months.1,2 There are a limited number of novel agents currently in clinical development for relapsed refractory MDS.

About Eltanexor

Eltanexor (KPT-8602) is an investigational novel SINE compound that functions by binding with, and inhibiting, the nuclear export protein, XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells.

In preclinical models, eltanexor has a broad therapeutic window with minimal penetration of the blood brain barrier and, therefore, has the potential to serve as another SINE compound for cancer indications. Following oral administration, animals treated with eltanexor show lower percentage of body weight loss and improved food consumption than animals similarly treated with selinexor. This allows more frequent dosing of eltanexor, enabling a longer period of exposure than is possible with selinexor.

Eltanexor is an investigational medicine and has not been approved by the United States Food and Drug Administration or any other regulatory agency.

Isofol Medical AB (publ) publishes interim report, January–March 2023

On May 3, 2023 Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), reported that the company’s interim report for January–March 2023 is now available, in Swedish, on the company’s website, www.isofolmedical.com (Press release, Isofol Medical, MAY 3, 2023, View Source [SID1234630926]).

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The information in the press release is intended for investors.

First quarter, January–March 2023
Net revenue amounted to TSEK 721 (4,006) and other revenue to TSEK 23 (1)
The result for the period amounted to TSEK -14,395 (-47,874)
Earnings per share amounted to SEK -0.09 (-0.30)
Cash and cash equivalents on March 31 amounted to TSEK 163,963 (332,035)
Significant events during the first quarter 2023
An extraordinary general meeting was held on 13 February to, in accordance with the board’s proposal, decide on an extra dividend to the shareholders and voluntary liquidation of the company. However, the board’s proposal did not achieve the required majority and was thus not voted through. As a consequence of the decision, all members of the board made their seats available and did not run for re-election.
Another extraordinary general meeting was held on February 28, following a written request to be convened by shareholders with a total shareholding corresponding to more than 10 percent of the shares in the company to elect a new board. Mats Franzén was elected as new board chairman and Jonas Pedersén and Jan-Eric Österlund were elected as new board members.
On February 28, the board appointed Thomas Andersson as the new CEO.
On March 6, Isofol presented a step-by-step process for the continued development of arfolitixorin.
On March 17, Roy Jonebrant was appointed as the new acting Chief Financial Officer.
Significant events after the event of the period
On April 28, Isofol informed that the company is starting preclinical evaluation of arfolitixorin in a research collaboration with Oncosyne AS in Norway.
CEO´s comment:
" We have taken the first steps in our communicated strategy to continue evaluating the drug candidate arfolitixorin in a cost-effective and risk-minimizing manner. The lab test we have initiated in collaboration with Oncosyne is expected to provide more information after the summer. Our assessment is that the planned activities can be financed with existing funds and have the potential to bring arfolitixorin significantly closer to a market", says CEO Thomas Andersson.

Audiocast, May 3, at 11:00 a.m. CEST
In conjunction with the publication of the interim report for the first quarter of 2023, Isofol invites investors, analysts, and media to an audiocast on May 3, 2023 at 11:00 a.m. CEST. The presentation will be held by Isofol´s Chairman of the board, Mats Franzén and CEO Thomas Andersson, who will give an update on the first quarter, followed by a Q&A-session. The presentation will be held in Swedish.

Date and time
May 3, 2023, at 11:00 a.m. CEST

Link to audiocast
If you wish to participate via the web and ask written questions, please use the link below:
View Source

The presentation will also be available on Isofol’s website after the broadcast:
View Source