Biopharma Has ‘Trials Progressing; Multiple 2022 Data Readouts’ Including for PTSD

Source: Streetwise Reports   05/19/2021

Updates on Aptinyx’s three central nervous system drug candidates and the company’s Q1/21 earnings are delivered in an H.C. Wainwright & Co. report.

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 stated 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 (PTSD) 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 in the first half of next year.

“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; its current share price is $2.48. The financial institution rates it Buy.

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Disclosures from H.C. Wainwright & Co., Aptinyx, Inc., Earnings Update, May 14, 2021

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Raghuram Selvaraju, 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 Aptinyx, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of April 30, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Aptinyx, 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 Aptinyx, Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did receive compensation from Aptinyx, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Aptinyx, Inc. during the past 12 months.

The Firm does not make a market in Aptinyx, Inc. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.