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Investing.com - H.C. Wainwright has reiterated its Buy rating and $26.00 price target on Septerna Inc (NASDAQ:SEPN), currently trading at $11.70 with a market cap of $517 million, following the company’s announcement that it has begun dosing participants in a Phase 1 trial. InvestingPro data shows the stock has surged over 100% in the past six months.
Septerna announced on August 21 that it has dosed the first participants in its Phase 1 trial of SEP-631, a selective oral small molecule being developed for the treatment of chronic spontaneous urticaria and other mast cell-driven diseases.
The randomized, placebo-controlled Phase 1 SAD/MAD clinical trial is expected to enroll approximately 150 healthy adult volunteers. Dosing is currently underway in the single ascending dose (SAD) portion of the trial, which will evaluate safety and tolerability at escalating oral doses.
The multiple ascending dose (MAD) portion of the trial will assess safety and tolerability over the treatment period, with pharmacodynamics evaluated through an icatibant skin challenge.
H.C. Wainwright noted that this development marks Septerna’s return to clinical-stage status following the discontinuation of SEP-786 in hypoparathyroidism, describing the news as "a meaningful value inflection point" for the company. InvestingPro analysis shows the company maintains strong liquidity with a current ratio of 22.09, though it’s currently burning through cash. Subscribers can access 8 additional ProTips and detailed financial metrics.
In other recent news, Septerna, Inc. reported its second-quarter financial results, revealing a widened net loss despite exceeding earnings expectations. The company posted an adjusted EPS loss of $0.56, which was $0.07 better than analyst projections of a $0.63 loss. Revenue for the quarter amounted to $100,000. Septerna’s net loss increased to $24.8 million, up from $16.4 million in the same period last year, primarily due to a rise in research and development expenses, which climbed to $22.2 million from $15.0 million year-over-year. In addition, Septerna has initiated a Phase 1 clinical trial for SEP-631, an oral treatment targeting chronic spontaneous urticaria and other mast cell-driven diseases. The trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SEP-631 in healthy adult volunteers. Approximately 150 participants are expected to enroll in the randomized, placebo-controlled study, which includes both single-ascending dose and multiple-ascending dose components.
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