Biotech Alert: Searches spiking for these stocks today

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:

• Fractyl Health (GUTS), 1,010% surge in interest

Pipeline and key clinical candidates for these companies:

Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease.

Recent news on these stocks:

August 6

Fractyl Health announced the pricing of its underwritten public offering of 19,047,619 shares of common stock and accompanying Tranche A and Tranche B warrants, for gross proceeds of $20M before deducting underwriting discounts, commissions, and offering expenses. Each share of common stock is being sold together with one Tranche A warrant with a 2-year term; and one Tranche B warrant with a 5-year term, exercisable following stockholder approval pursuant to Nasdaq rules; at a combined public offering price of $1.05. Both the Tranche A and Tranche B warrants are fixed-priced, do not have any variable priced resetting mechanisms, and contain no price-based anti-dilution or ratchets. The exercise price for both warrant tranches is $1.05 per share. The Tranche A warrants are callable at the Company’s option following the release of 3-month randomized midpoint clinical data from the ongoing REMAIN-1 study, subject to satisfaction of certain conditions including that the average trading price of the stock exceeds $1.37 per share for 15 consecutive trading days and a minimum daily trading volume threshold. In addition, Fractyl granted the underwriters a 30-day option to purchase up to an additional 2,857,142 shares of common stock, along with associated Tranche A and Tranche B Warrants, at the public offering price, less underwriting discounts and commissions. Fractyl expects to receive gross proceeds of approximately $20M from this offering, excluding any potential future proceeds from the exercise of the warrants. If fully exercised for cash, the Tranche A and Tranche B warrants could yield up to an additional $40 million in future gross proceeds. The Company intends to use the net proceeds from the proposed offering, together with its existing resources, to support its Revita and Rejuva pipeline programs and for working capital and other general corporate purposes. Ladenburg Thalmann is acting as book-running manager for the offering. This offering is expected to close on or about August 7, subject to the satisfaction of customary closing conditions.

August 5

Fractyl Health announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock, in an underwritten public offering. Each share of common stock or pre-funded warrant will be sold with accompanying common warrants to purchase shares of common stock. All of the shares of common stock, pre-funded warrants and common warrants are being offered by Fractyl. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Fractyl intends to use the net proceeds from the proposed offering, together with its existing cash and cash equivalents, to support its Revita and Rejuva pipeline programs and for working capital and other general corporate purposes. Ladenburg Thalmann & Co. is acting as sole book-running manager for the proposed offering.

Fractyl Health announced two-year follow-up data from the Germany Real-World Registry study that showed a single Revita procedure led to durable weight loss and improved glucose control in people with obesity and advanced T2D. These data underscore Revita’s potential to provide a potent and durable non-drug alternative for patients struggling with long-term metabolic control. The Germany Real-World Registry study is a prospective, post-market, clinical follow-up study to evaluate the Revita procedure in patients with inadequately controlled T2D. Participants had a baseline HbA1c between 7%-10%, BMI of 45 kg/m, and were on at least one glucose-lowering agent. At baseline, the first nine participants with two years of follow-up had a median age of 62 years, median weight of 104 kg, and a median HbA1c of 9.6%, despite being on up to three GLAs. After a single Revita procedure, these nine participants achieved a median weight loss of 9.6% with weight decreasing from 104 kg to 97 kg at 1 year, a result that was sustained throughout 2 years. Notably, 7 of 8 participants experienced at least a 5% weight reduction, and 5 of 8 saw reductions of 10%. Only one participant, with a history of cortisone therapy known to cause weight gain, experienced modest weight gain. In parallel, median HbA1c reduced by 1.6%, from 9.6% at baseline to 7.2% at 1 year, and this improvement was sustained throughout two years, even as participants reduced or stabilized their use of GLAs. Three patients were on a GLP-1 drug at the time of study entry and were still on a GLP-1 drug through two years of follow-up. No device- or procedure-related serious adverse events have been reported to date. In this cohort, weight loss and glucose improvements began as early as one month after the Revita procedure and were sustained through two years of follow-up. These findings highlight the potential of a single Revita treatment to deliver durable weight maintenance in a real-world setting. Thirty-four participants are currently enrolled in the Germany Real-World Registry study. While the study is no longer enrolling new patients, Fractyl will continue protocol-defined follow-up of participants and share outcomes on an ongoing basis. Revita is being studied in an ongoing IDE-approved REMAIN-1 pivotal study to evaluate its potential safety and efficacy in post-GLP-1 weight maintenance. These new findings from Germany add real-world momentum to Fractyl’s upcoming pivotal trial readouts, including Midpoint Cohort data from its ongoing REMAIN-1 study, which is expected in Q3 2025, and primary endpoint data from the Pivotal Cohort, anticipated in H2 2026. Together, these clinical milestones are designed to demonstrate Revita’s potential to help maintain weight loss after GLP-1 discontinuation and inform its possible role in supporting durable metabolic outcomes for patients with obesity.

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About “Biotech Alert”

The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.

This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel’s online financial news media ecosystem.

This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.