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: 

• Phio Pharmaceuticals (PHIO), 1,008% surge in interest
• Hepion Pharmaceuticals (HEPA), 643% surge in interest
• Aslan Pharmaceuticals (ASLN), 379% surge in interest
• Cidara Thera (CDTX), 74% surge in interest

Pipeline and key clinical candidates for these companies:

Phio Pharmaceuticals is a clinical stage biotechnology company whose proprietary INTASYL RNAi technology is designed to make immune cells more effective in killing tumor cells. “INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized formulations or drug delivery systems,” the company has stated.

Hepion Pharmaceuticals is a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis, hepatocellular carcinoma, and other chronic liver diseases. Hepion’s lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models and is currently in Phase 2 clinical development for the treatment of NASH. 

Aslan Pharmaceuticals is a clinical-stage, immunology-focused biopharmaceutical company developing eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis with the potential to improve upon current biologics used to treat allergic disease, and has reported positive topline data from a Phase 2b dose-ranging study in moderate-to-severe AD patients. Aslan is currently investigating eblasakimab in dupilumab-experienced, moderate-to-severe AD patients in the TREK-DX Phase 2 trial, with topline data expected at the end of 2024. Aslan is also developing farudodstat, a potent oral inhibitor of the enzyme dihydroorotate dehydrogenase as a potential first-in-class treatment for alopecia areata in a Phase 2a, proof-of-concept trial with an interim readout expected in Q3 2024.

Cidara Therapeutics is using its proprietary Cloudbreak platform to develop novel drug-Fc conjugates. These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment. DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA and EC approval for REZZAYO, which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S.

Recent news on these stocks:

April 22nd

Cidara Therapeutics announced that the company effected a reverse stock split of its issued and outstanding common stock, at a ratio of 1-for-20. The company’s common stock will begin trading on a split-adjusted basis commencing upon market open on April 24, 2024. The reverse stock split reduces the number of shares of common stock issuable upon the conversion of the company’s outstanding shares of preferred stock and the exercise or vesting of its outstanding stock options, restricted stock units and warrants in proportion to the ratio of the reverse stock split and causes a proportionate increase in the conversion and exercise prices of such preferred stock, stock options and warrants.

Cidara Therapeutics “announced on April 17, 2024, that the Company received a notice from the Listing Qualifications Staff of The Nasdaq Stock Market LLC advising the Company that its failure to timely file its Annual Report on Form 10-K for the fiscal year ended December 31, 2023 with the Securities and Exchange Commission, in contravention of Nasdaq Listing Rule 5250(c)(1), could serve as an additional deficiency and basis for the delisting of the Company’s securities from Nasdaq.”

Cidara Therapeutics also reported Q4 losses per share of (4c), with consensus at (10c), and Q4 revenue of $17.6M, with consensus at $11.54M. Cash and cash equivalents totaled $35.8M as of December 31, 2023, compared with $32.7M as of December 31, 2022.

“2023 included significant accomplishments throughout our business within both our Cloudbreak drug-Fc conjugate and our REZZAYO programs,” said Jeffrey Stein, president and CEO. “With respect to our DFC platform, we continue to generate and present compelling data from our oncology programs as well as our CD388 influenza program partnered with Janssen. We have multiple key catalysts expected this year, including the filing of an Investigational New Drug Application in mid-2024 for CBO421, a potential best-in-class inhibitor of CD73. We recently presented promising new data on CD73/PD-1 multispecific DFC, CCR5-targeting DFC and CBO421 at the American Association for Cancer Research Annual Meeting.”

Aslan Pharmaceuticals announced interim results from the Phase 2 study of eblasakimab in moderate-to-severe atopic dermatitis adult patients previously treated with dupilumab, TREK-DX. The primary endpoint, which is the percent change in Eczema Area Severity Index score from baseline to week 16, was statistically significant when compared to placebo, even though the interim analysis was not powered for statistical significance due to the sample size. 73.3% of eblasakimab-treated patients achieved a reduction in EASI score of at least 75% from baseline compared to 14.3% on placebo.

The TREK-DX trial is enrolling moderate-to-severe adult AD patients who have discontinued dupilumab treatment for any reason, including inadequate control of AD, loss of access or an adverse event, after at least 16 weeks of dupilumab treatment. In an interim analysis of data from 22 patients, comprising the intent-to-treat population, that were randomized 2:1 active to placebo, 17 patients completed the 16-week treatment period and five patients discontinued before the completion of the 16-week treatment period. Patients treated with eblasakimab 400mg once weekly saw a rapid onset of action in the first few weeks of treatment, with a statistically significant improvement in EASI score by Week 4 compared to placebo. By Week 16, an 86.9% mean reduction4 in EASI score from baseline was observed for eblasakimab-treated patients compared to a 51.2% reduction for placebo.

Clinically meaningful improvements were achieved in other key efficacy measures compared to placebo at Week 16. Of the six patients treated with eblasakimab who previously had an inadequate response to dupilumab, 66.7% achieved EASI-90 and 66.7% achieved a vIGA score of 0 or 1. Treatment was well-tolerated and no new safety signals were identified. There were no reports of conjunctivitis or injection site reactions in the active or placebo arm.

As previously announced, the TREK-DX recruitment criteria were tightened in October 2023 to enroll only patients with a baseline EASI score of 18 or above. These more stringent criteria will be the basis of analysis in the topline readout, expected at the end of 2024. Of the 22 patients in this interim analysis, 15 meet these amended enrollment criteria, The interim data will be submitted for presentation at an upcoming scientific conference.

April 19th

Hepion Pharmaceuticals announced that it has begun wind-down activities in its ASCEND-NASH Trial, while continuing to explore strategic alternatives, as previously announced in December 2023. ASCEND-NASH is a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of rencofilstat dosed for 12 months, with a target enrollment of 336 subjects. Enrollment was paused in April 2023, with 151 subjects randomized. To date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy. An additional 40 subjects will provide significant safety data for evaluation. These patients will be added to our existing safety database.

“We are disappointed to announce the wind-down of our Phase 2 NASH trial, which we attribute entirely to resource constraints,” said John Brancaccio, Executive Chairman of Hepion. “The company remains committed to its strategic alternative efforts previously announced in December 2023. Given the number of enrolled NASH patients to date and the low probability of generating relevant efficacy data to support a registrational trial with our current cash resources, we have opted to wind down the program and assure that patients are transitioned out of the trial in a safe and compliant manner. There were no safety concerns observed for rencofilstat in the ASCEND-NASH trial.”

Aslan Pharmaceuticals announced that it received a letter on April 18, 2024 from The Nasdaq Stock Market informing the company that it failed to maintain the continued listing requirement under Nasdaq Listing Rule 5550(b)(1) for the Nasdaq Capital Market, which requires that a listed company’s stockholders’ equity be at least $2.5M. Based upon the reported stockholders’ equity of a deficit of $13.3M in the company’s Form 20-F for the period ended December 31, 2023, the company did not meet the Stockholders’ Equity Requirement. The company has a period of 45 calendar days from the date of the Letter, or until June 3, 2024, to submit a plan to regain compliance with the Stockholders’ Equity Requirement. If such a plan is submitted and accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Letter for the company to regain compliance.

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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.