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:

• Telesis Bio (TBIO), 358% surge in interest
• Agios Pharmaceuticals (AGIO), 175% surge in interest
• Dare Bioscience (DARE), 104% surge in interest
• Vir Biotechnology (VIR), 92% surge in interest
• Cara Therapeutics (CARA), 83% surge in interest

Pipeline and key clinical candidates for these companies:

Telesis Bio says it is “empowering scientists with the ability to create novel, synthetic biology-enabled solutions for many of humanity’s greatest challenges.” The Gibson Assembly method and the first commercial automated benchtop DNA and mRNA synthesis system enable rapid, accurate and reproducible writing of DNA and mRNA for numerous downstream markets, the company has stated.

Agios says it is “the pioneering leader in PK activation and is dedicated to developing and delivering transformative therapies for patients living with rare diseases.” In the U.S., Agios markets a first-in-class pyruvate kinase, PK, activator for adults with PK deficiency, the first disease-modifying therapy for this rare, lifelong, debilitating hemolytic anemia. Building on the company’s deep scientific expertise in classical hematology and leadership in the field of cellular metabolism and rare hematologic diseases, Agios is advancing a robust clinical pipeline of investigational medicines with programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. In addition to its clinical pipeline, Agios is advancing a preclinical TMPRSS6 siRNA as a potential treatment for polycythemia vera, and a preclinical PAH stabilizer as a potential treatment for phenylketonuria.

Daré Bioscience is advancing products for women’s health, stating that the company’s mission is “to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health.” Daré’s first FDA-approved product, XACIATO vaginal gel, is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause.

Vir Biotechnology is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir has several preclinical candidates in its pipeline, including RSV/MPV and HPV.

Cara Therapeutics is a commercial-stage biopharmaceutical company that notes that its Kapruvia injection is “the first and only” MHRA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The company is developing an oral formulation of difelikefalin and has Phase 3 programs ongoing for the treatment of pruritus in patients with non-dialysis dependent advanced chronic kidney disease and atopic dermatitis. In addition, the company has initiated a Phase 2/3 program of oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica.

Recent news on these stocks:

February 26

Telesis Bio announced certain preliminary, unaudited financial results for the fourth quarter and year ended December 31, 2023. The results are subject to the completion of the company’s year-end financial reporting processes, reviews, and audit. BioXp kit revenue for Q4 of 2023 is expected to exceed $1.0M, the highest level in the history of the company and an increase of 59.6% from the prior quarter and 25.9% compared to the same quarter last year. This increase was driven by rapid adoption of highly differentiated mRNA workflows, which grew at more than 300% compared to the same quarter last year. For FY23, BioXp kit sales increased 10% compared to the prior year. Total consolidated revenue for FY23 is expected to be $27.5M, up slightly from $27.4M achieved in 2022. Total revenue for Q4 of 2023 is expected to be $7.0M, a 26.3% reduction from $9.5M for the same period in 2022 due primarily to capital spending weakness in end markets and the resulting mix-shift toward lower-priced BioXp 3250 instruments. Total revenue, excluding BioXp instrument sales and discontinued BioFoundry Services operations, were $20.9M for the full fiscal-year period, an increase of 12.4% compared to $18.6M for the same categories in the prior year period. Collaboration revenue for the year, driven in part by the successful achievement of several key technology milestones, is expected to be $8.M, an increase of 30.7% above the prior year’s collaboration revenue of $6.M.

February 22

Dare Bioscience announced that additional data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in women with female sexual arousal disorder will be presented at the upcoming International Society for the Study of Women’s Sexual Health Annual Meeting. These data include efficacy results across multiple endpoints in the proposed Phase 3 study population. “The data from the Phase 2b RESPOND study demonstrate that Sildenafil Cream treatment reduced sexual distress across multiple measures in a clinically meaningful way,” said Dr. Andrew Goldstein, Medical Advisor for Dare Bioscience and former President of ISSWSH. “The results highlight specific endpoints with the strongest responses including arousal sensation, desire, orgasm, as well as stress, guilt, and embarrassment about the sexual dysfunction. Most importantly, based on these responses, we’ve identified the study population that will likely demonstrate the most significant benefit from Sildenafil Cream treatment, which consists of healthy premenopausal women with female sexual arousal disorder, including those who suffered from a lack of sexual desire due to their decreased arousal.” Dr. Goldstein will also present data on sexual experiences from the study, which showed that Sildenafil Cream users had more sexual experiences and more solo sexual experiences than placebo users. Notably, Sildenafil Cream enhanced solo, unpartnered sexual experiences, which represented approximately 1 in 5 sexual events in the Phase 2b RESPOND study. Sildenafil, a phosphodiesterase-5 inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra for the treatment of erectile dysfunction in men. Sildenafil Cream is an investigational, proprietary topical cream formulation specifically designed to be used on-demand at the time of sexual activity to increase blood flow to the genital tissue in women. If development is successful, Sildenafil Cream has the potential to be the first product approved by the FDA to treat FSAD. Dare Bioscience previously announced a positive end-of-Phase 2 meeting with the FDA supporting advancement of Sildenafil Cream for the treatment of FSAD. The FDA recently confirmed that it aims to complete its review of the Phase 2b RESPOND study data and provide comments within the second quarter of 2024 on the proposed primary and secondary patient reported outcome endpoints for the planned Phase 3 pivotal trials of Sildenafil Cream to support potential product registration and labeling.

Vir Biotechnology reported Q4 EPS (86c) against a consensus of ($1.01). Reported Q4 revenue of $16.8M against a consensus of $12.2M. As of December 31, 2023, the company had approximately $1.63B in cash, cash equivalents and investments. Cash, cash equivalents and investments declined by approximately $108M during Q4 of 2023. “Vir is poised to have a transformational year, with catalysts expected in the second and fourth quarters, which build off last year’s clinical trial progress in our chronic hepatitis delta and B programs. We believe these data readouts, notably the SOLSTICE delta update in the second quarter, hold tremendous promise for patients as we work towards solutions for these deadly diseases,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s CEO. “Our financial strength allows us to fund multiple clinical programs through major inflection points while enabling the flexibility to invest in external innovation opportunities.”

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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.