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Co. Reaches Major Milestone With Novel Drug
Research Report

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The biopharma initiated enrollment of a targeted 420 patients for one of its Phase 3 clinical trials evaluating its new cardiac myosin inhibitor, noted an H.C. Wainwright & Co. report.

Cytokinetics Inc. (CYTK:NASDAQ) began enrolling patients in the Phase 3 ACACIA-HCM clinical trial evaluating its drug aficamten in hypertrophic cardiomyopathy (HCM), reported H.C. Wainwright & Co. analyst Dr. Joseph Pantginis in a September 6 research note.

"ACACIA-HCM stands as a significant milestone in the development of aficamten," Pantginis wrote. "This development is particularly exciting, as it brings Cytokinetics one step closer to the anticipated US$50 million milestone payment from Royalty Pharma upon the initiation of patient dosing in ACACIA-HCM."

Attractive Return, Buy Rating

Accordingly, H.C. Wainwright reiterated its target price on Cytokinetics of US$49 per share, noted Pantginis. The biopharma is currently trading at about US$35.16 per share in comparison.

The price difference implies a compelling return for investors of 39%.

California-based Cytokinetics remains a Buy.

Aficamten vs. Placebo

Pantginis reviewed the specifics of the ACACIA-HCM study, an assessment comparing aficamten to placebo on cardiac endpoints in adults with symptomatic nonobstructive hypertrophic cardiomyopathy. Aficamten is Cytokinetics' cardiac myosin inhibitor.

The biopharma aims to enroll about 420 patients for this multicenter, double-blind, randomized study. All patients will start out receiving aficamten 5 milligrams (5 mg) daily or a placebo. After weeks two, four, and six, patients with a left ventricular ejection fraction (LVEF) of 60% or higher may have their dose increased to 10, 15, or 20 mg. Otherwise, patients will remain on their current dose or even have it lowered if their LVEF is less than 50%.

All patients will be assessed at week 36 for the primary endpoint of the Kansas City Cardiomyopathy Questionnaire, Pantginis relayed. After, patients will continue being treated for up to 72 weeks, during which period additional analyses will be done.

"We are excited about the path ahead and eagerly await future data readouts and valuable insights from the Phase 3 study," Pantginis commented.

Aficamten vs. Metoprolol

In patients with obstructive hypertrophic cardiomyopathy who are symptomatic (versus nonobstructive in ACACIA-HCM), Cytokinetics just started a separate Phase 3 trial called MAPLE-HCM. In this study, aficamten will be compared to the beta blocker, metoprolol, in this patient population in which beta blockers are currently the standard of care, Pantginis reported.

"MAPLE-HCM has the ability to demonstrate aficamten's potential as first-line therapy in patients with hypertrophic cardiomyopathy," the analyst added.

Target enrollment for the trial is 170 patients. On a one-to-one basis, patients will be randomized to either aficamten or metoprolol. Patients will receive up to four escalating doses of aficamten (5, 10, 15, or 20 mg, once daily) or metoprolol (50, 100, 150, or 200 mg, once daily), depending on echocardiographic results at weeks two, four, and six.

The trial's primary endpoint is a change in pulmonary venous oxygen tension (pVO2) from baseline to week 24 as measured by cardiopulmonary exercise testing.

Patients who complete MAPLE-HCM may participate in the ongoing FOREST-HCM trial assessing the long-term (48-week) efficacy of aficamten.

Tackling Cardiac Hypercontractility

In other news, relayed Pantginis, dosing has started in the Phase 1 trial evaluating Cytokinetics' small molecule cardiac myosin inhibitor, CK-4021586. The biopharma intends for the drug to reduce hypercontractility linked to heart failure with preserved ejection fraction.

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Important Disclosures:

  1. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
  2. The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
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Disclosures for H.C. Wainwright & Co., Cytokinetics Inc., September 6, 2023

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to [email protected] and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet.

H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Joseph Pantginis, Ph.D., Matthew Keller, Ph.D. and Sara Nik, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Cytokinetics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of August 31, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Cytokinetics, Inc..

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Cytokinetics, Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did not receive compensation from Cytokinetics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Cytokinetics, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person.

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