H.C. Wainwright Upgrades Iterum Therapeutics (ITRM) to Buy
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H.C. Wainwright analyst Ed Arce upgraded Iterum Therapeutics (NASDAQ: ITRM) from Neutral to Buy with a price target of $2.50.
The analyst comments "Recent financings provide substantial runway, allowing investor focus to turn to potential FDA approval and launch. We downgraded ITRM last June on an unclear regulatory path forward for sulopenem (it had missed the primary endpoint on two of three Phase 3 trials) and a short cash runway without an ability to commercialize the drug (or a partner), even if it were approved. Since then, the company has achieved: (1) unequivocally positive results, in our view, in the final Phase 3 trial in uncomplicated urinary tract infections (uUTI), called SURE1. The NDA was filed in 4Q20 and the FDA accepted the NDA on January 25. The PDUFA date is July 25 2021. On Friday March 12 (4Q20 earnings), the company also announced an AdCom is set for June 2; (2) In February 2021, Iterum announced it has engaged EVERSANA (private) for pre-launch activities and intends to execute an agreement for commercialization services as well. It expects to have 50-100 reps trained and ready to go at launch. Importantly, given the indication (uUTI), Iterum plans to focus on the community setting exclusively (not the hospital), with a highly targeted marketing strategy focused on specific zip codes that meet its specific criteria; (3) last, and critically, Iterum has raised combined net proceeds of $74.3M in February (total cash >$100M at the end of February) with a cash runway of about 2 years (“into 1H23”). In addition, we believe sulopenem is likely to be the first oral “penem” class antibiotic drug to reach the market. Furthermore, we believe Iterum now has sufficient resources to significantly penetrate the addressable market of quinolone non-susceptible uUTIs, which represents 6.5M infections annually in the U.S. Despite the significant dilution recently, we arrive at a risk-adjusted fair value of $2.50 per share, versus last close of $1.55 (implies 61% upside). As such, we upgrade ITRM shares to Buy and establish a one-year price target of $2.50 per share."
Shares of Iterum Therapeutics closed at $1.57 yesterday.
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Create E-mail Alert Related CategoriesAnalyst Comments, Hot Comments, Hot Upgrades, Upgrades
Related EntitiesEarnings, PDUFA, H.C. Wainwright, AdCom, Ed Arce, FDA
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