H.C. Wainwright & Co. raised its price target on Medivir AB (MVIR-B:STO) to SEK50 from SEK30 to wholly reflect the potential opportunity with its clinical stage drug fostrox in hepatocellular carcinoma, Joseph Pantginis, an analyst with the financial firm, reported in an August 19, 2022 research note. This new target, assigned after Medivir's Q2/22 financial and corporate update, implies significant potential return for investors from the biopharma's current price of SEK7.84.
In a financial overview of Medivir's Q2/22, Pantginis noted the company posted an earnings per share (EPS) of -SEK0.42. In comparison, consensus and H.C. Wainwright's EPS estimates were -SEK0.41 and -SEK0.58, respectively. At quarter's end, Medivir had SEK162.8 million in cash.
Operationally during Q2/22, Medivir continued advancing fostrox, or fostroxacitabine bralpamide, which is in the early stages of a Phase 1b/2a clinical trial in patients with hepatocellular carcinoma, a difficult to treat group, Pantginis relayed. Fostrox will remain a primary focus and key driver for this Swedish cancer drug developer.
Fostrox "has the potential to become the first liver-targeted and orally administered drug for patients with hepatocellular carcinoma and other forms of liver cancer," Pantginis commented. "It has a strong potential as a combination agent with cyclin-dependent inhibitors or tyrosine kinase inhibitors."
In Phase 1b of the current trial, two parallel dose streams of fostrox are being assessed to establish the recommended dose for Phase 2a. The second phase, an expansion study, will evaluate the safety and efficacy of fostrox in combination with lenvatinib and/or fostrox in combination with Keytruda.
Enrollment has been going more slowly than expected. However, dosing of enrolled patients is underway, and the plan to submit an investigational new drug application, including initial safety and efficacy data, to the U.S. Food and Drug Administration in 2023 remains on schedule. Pantginis attributed lagging enrollment to a number of studies competing for the same population now that COVID-19 restrictions are mostly behind us.
To help speed up enrollment, Medivir is employing new strategies. It amended the patient criteria, making it easier for them to qualify. Also, the company is adding investigators and trial sites and increasing its presence at the active centers. There are now 15 active sites in Spain, the United Kingdom, and South Korea.
"Hepatocellular carcinoma is particularly common in Asia, and the trial could provide the opportunity for increased interaction with sites and key opinion leaders as well as key exposure to potential partners in this territory," wrote Pantginis.
In other Medivir news, "the company's out-licensed candidates are progressing as planned," Pantginis pointed out. For instance, the first dose escalation cohort was cleared in the Phase 1 trial of Medivir's birinapant in combination with IGM Biosciences' DR5-agonist antibody IGM-8444 in solid tumors. Initial data are expected soon.
H.C. Wainwright & Co. has a Buy rating on Medivir.
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Disclosures For H.C. Wainwright & Co., Medivir AB, Aug. 19, 2022
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. , 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 Medivir AB and IGM Biosciences, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of July 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Medivir AB and IGM Biosciences, 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 did not receive compensation from Medivir AB and IGM Biosciences, 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 Medivir AB and IGM Biosciences, Inc. as of the date of this research report.
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