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: 

• Gritstone Oncology (GRTS), 615% surge in interest
• Brainstorm Cell (BCLI), 545% surge in interest
• Soligenix (SNGX), 479% surge in interest
• Verrica Pharmaceuticals(VRCA), 131% surge in interest
• IGM Biosciences (IGMS), 116% surge in interest
• Novavax (NVAX), 81% surge in interest

Pipeline and key clinical candidates for these companies:

Gritstone Oncology is “working to create the world’s most potent vaccines” by leveraging its “innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets,” the company says. Gritstone has programs in viral diseases and solid tumors.

BrainStorm Cell Therapeutics is a developer of autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the FDA and the EMA for the treatment of amyotrophic lateral sclerosis, ALS. BrainStorm has completed a Phase 3 pivotal trial in ALS; this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases. Their Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. Development programs in this business segment also include expansion of synthetic hypericin into psoriasis, their first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation including pediatric Crohn’s disease.

Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. On July 21, 2023, Verrica’s lead product, Ycanth, became the first treatment approved by the FDA to treat pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. VP-102 is also in development to treat common warts and external genital warts, two of the largest unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 for dermatologic oncology conditions.

IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, autoimmune and inflammatory diseases and infectious diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets.

Novavax says it promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. Novavax offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response.

Recent news on these stocks:

October 3

Soligenix announced that it has established a partnership agreement with Sterling Pharma Solutions to optimize and implement a commercially viable, scalable production technology for synthetic hypericin. Synthetic hypericin, the active ingredient in the topical drug product formulations HyBryte and SGX302 being developed for the treatment of cutaneous T-cell lymphom and psoriasis, respectively, is a potent photosensitizer that is topically applied to skin lesions. Soligenix and Sterling are currently working to transfer and optimize the manufacturing processes and analytics to enable GMP manufacturing for clinical trials with the intent of establishing a long-term commercial manufacturing collaboration.

In a regulatory filing, Novavax stated that it is aware of an analyst report published on October 1, which referred to discussions with Novavax’s management regarding, among other things, the anticipated U.S. market for COVID-19 vaccination for the 2024-2025 vaccination season. “Novavax would like to clarify that while it has anticipated the COVID-19 vaccination market in the U.S. will be similar to last year, it has neither updated nor reaffirmed its full year 2024 financial guidance issued on August 8, 2024,” the filing stated.

October 2

Needham downgraded Verrica Pharmaceuticals to Hold from Buy without a price target. The company announced a significant cost-cutting exercise to stay afloat given its dwindling cash balance and limited operational runway, the analyst tells investors in a research note. The firm says the over 50% downsizing of Ycanth’s promotional efforts will represent a “significant headwind for a launch that had shown recent signs of struggle.” While Needham believes in Ycanth’s potential in molluscum and common warts, the firm says the current focus is on addressing capital needs, which will likely require a “highly-dilutive” financing event.

September 30

Gritstone announced interim Phase 2 data from the ongoing Phase 2 study evaluating GRANITE, its individualized neoantigen targeting immunotherapy, in frontline microsatellite stable colorectal cancer, or MSS-CRC. The randomized, controlled study is designed to evaluate the clinical benefit of maintenance therapy with GRANITE in combination with immune checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Overall progression-free survival data show an encouraging benefit for GRANITE patients. As expected, the greatest benefit was observed in the 50% of patients with lower disease burden at study entry, as measured by circulating tumor DNA at study baseline. Continued follow-up is needed to fully assess GRANITE effects and determine whether a plateau of improved PFS is achieved. The most recent ctDNA assessments for the 20 patients who remain without disease progression were supportive of potential benefit from treatment with GRANITE: 12 of 13 GRANITE patients had stable ctDNA titers below the assay limit of quantitation; 4 of 7 control patients exhibited the same characteristic. Interim data demonstrated an emerging PFS benefit to all GRANITE recipients 21% relative risk reduction of progression or death with GRANITE vs. standard of care control in all treated population 33% GRANITE and 23% of control patients remain on study and free of progression. Last ctDNA assessment is below the assay LOQ in 12/13 GRANITE and 4/7 control patients. Clinical benefit was most notable in patients with low disease burden. 38% relative risk reduction of progression or death with GRANITE vs. SOC control with low ctDNA subgroup. Low baseline ctDNA is a likely prognostic and predictive factor. Immune data were consistent with clinical activity. Functional neoantigen-specific T cells were observed in all 16/16 GRANITE patients tested by ELISPOT. Association of PFS and peak ex vivo ELISPOT responses was apparent, suggesting that ex vivo ELISPOT may be a surrogate for PFS. GRANITE demonstrated a favorable safety and tolerability profile. No patients discontinued study treatment due to an adverse event. Common adverse events were the mild systemic and local effects associated with any potent vaccine, i.e. transient flu-like illness. One treatment-related serious AE occurred in the GRANITE arm. Gritstone plans to review the PFS data with FDA in the coming months and agree on next steps to advance GRANITE, including a potential Phase 2 or 3 trial using ctDNA levels as eligibility criteria.

Brainstorm Cell Therapeutics effected a reverse stock split of the company’s common stock at a ratio of one-for-fifteen. The company believes that effecting the reverse stock split will assist in its efforts to meet the Nasdaq continued listing standards and to continue to have its common stock remain listed and traded on Nasdaq. In particular, the company expects that the reverse stock split will increase the per share bid price of its common stock above the $1.00 required by Nasdaq’s Minimum Bid Price Requirement.

IGM Biosciences announced a strategic pivot and pipeline transformation. The company’s lead candidates include imvotamab, a CD20 x CD3 bispecific T cell engager being developed in rheumatoid arthritis, systemic lupus erythematosus and myositis, and IGM-2644, a CD38 x CD3 bispecific T cell engager, which is expected to enter into a clinical study for generalized myasthenia gravis by the end of 2024. IGM also announced today that Mary Beth Harler has been appointed as CEO and to the board of directors. Harler joined IGM in 2021 as president, autoimmunity and inflammation.

In light of the emerging data from IGM’s ongoing randomized clinical trial of aplitabart in second-line metastatic colorectal cancer, together with the significant opportunity in autoimmunity, the company has decided to immediately begin taking steps, including a reduction in force, to minimize its future spending on the research and clinical development of aplitabart and other oncology candidates. Final data from the randomized clinical trial of aplitabart in second-line metastatic colorectal cancer will be shared in an appropriate forum in the future. As a result of these actions, IGM believes it can extend its current cash runway into 2027.

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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.