In a May 14 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that Aptinyx Inc. (APTX:NASDAQ) "has made meaningful progress across several clinical indications with the three clinical-stage assets in its pipeline—namely, NYX-2925, NYX-458 and NYX-783—over the past few months." He also purported that these therapeutics' eventual "data readouts could be risk-mitigated value inflection points."
Selvaraju specified where each of the three assets stands in the clinic and what investors can next expect with each program.
Regarding NYX-783, Aptinyx recently discussed it in a positive Type C meeting with the U.S. Food and Drug Administration (FDA). Topics covered included how best to develop the therapy in post-traumatic stress disorder and the optimal design for next study. Aptinyx aims to design the Phase 2b trial so that it can serve as one of the two well-controlled studies required by the FDA for a new drug registration. The next step for the biopharma and NYX-783 is to finalize the design. Aptinyx targets H2/21 as the time frame in which to commence the trial.
"The NYX-783 clinical program should be viewed as having been partly risk mitigated by the statistically significant CAPS-5 efficacy data from the previously reported Phase 2 trial," Selvaraju commented.
As for NYX-458, the Illinois-headquartered firm, in March, recommenced enrollment for the exploratory Phase 2 trial in about 100 patients with cognitive difficulties associated with both Parkinson's disease and dementia with Lewy bodies. The biopharma expects to report study data in H2/22.
Selvaraju highlighted that the market does not seem to be giving Aptinyx any credit for its NYX-783 or NYX-458 therapeutics, only for NYX-2925. He added that the NYX-458 program specifically is "already being treated as something of a wild card and thus, its result would be more likely to have a favorable impact."
In terms of NYX-2925, two Phase 2 trials of the drug candidate are underway, one in diabetic neuropathic pain, the other in fibromyalgia. Aptinyx anticipates releasing topline data for both soon, in H1/22.
"These readouts appear relatively low risk, given the validated nature of the NMDA receptor target and the prior proof-of-concept clinical data generated for NYX-2925 in chronic pain," Selvaraju wrote.
He noted, too, that favorable topline data from any of these clinical trials "implies substantial upside," considering Aptinyx's current $22 million enterprise value.
Selvaraju summarized the biopharma's Q1/21 financial results. The company incurred a net loss of $0.22 per share, greater than H.C. Wainwright's estimate of $0.20 per share. At the quarter's end, Aptinyx had $147.8 million, which included $14.5 million from at-the-market sales of its common stock during Q1/21.
Looking forward, H.C. Wainwright now models a full-year 2021 net loss for Aptinyx of $0.93 per share, changed from $0.92. For full-year 2022, it projects a net loss of $1.06 per share, revised from $1.11.
As for a price target on Aptinyx, H.C. Wainwright assigns it $8 per share. This suggests the stock could be a triplebagger in light of its current share price, $2.39. The financial institution rates it Buy.
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