These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
Pipeline and key clinical candidates for these companies:
Altamira Therapeutics is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets via the OligoPhore/SemaPhore platforms; nasal sprays for protection against airborne allergens and, where approved, viruses or for the treatment of vertigo; and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss.
InflaRx is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a and C5aR technologies to discover and develop first-in-class or best-in-class, potent and specific inhibitors of the complement activation factor known as C5a and its receptor known as C5aR.
Autolus is developing next-generation, programmed T cell therapies for the treatment of cancer. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. Those include, Obe-cel, a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies; AUTO1/22, a novel dual targeting CAR T cell-based therapy candidate based on obe-cel; and AUTO4, a programmed T cell product candidate in clinical development for T cell lymphoma.
Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions.
Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma and leptomeningeal metastases.
Evelo Biosciences is a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis, SINTAX, with systemic therapeutic effects. The company's product candidates are pharmaceutical preparations of single strains of microbes or their extracellular vesicles, or EVs. Evelo initially is developing EDP1815 in psoriasis and atopic dermatitis and EDP2939 in psoriasis. "If shown to be effective in inflammatory disease mediated by the Th1, Th2 or Th17 inflammatory pathways, these same investigational medicines could be effective in additional inflammatory diseases, such as psoriatic and other forms of arthritis, asthma, allergy, and inflammatory bowel disease," the company says.
Seres Therapeutics is a microbiome therapeutics company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres' SER-109 program achieved "the first-ever positive pivotal clinical results for a targeted microbiome drug candidate," according to the company, and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced to prevent further recurrences of C. difficile infection. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation to reduce incidences of gastrointestinal infections, bloodstream infections and graft-versus-host disease as well as additional preclinical stage programs targeting Infection Protection in medically compromised patients.
Geron is a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Its investigational first-in-class telomerase inhibitor, imetelstat, "harnesses Nobel Prize winning science in a treatment that may alter the underlying course of these diseases," the company says.
Recent news on these stocks:
InflaRx N.V. announced that the first patient has been dosed in its Phase III study investigating the efficacy and safety of vilobelimab in ulcerative PG, a rare neutrophilic and inflammatory skin disease characterized by destructive, painful cutaneous ulcers. "We are pleased that the first patient has been dosed in the U.S. in our pivotal Phase III study with vilobelimab for the treatment of ulcerative pyoderma gangrenosum. There are currently no approved treatments for this debilitating disease in either the U.S. or Europe, and therefore, there remains a high unmet medical need for these patients," said Dr. Camilla Chong, MD, Chief Medical Officer of InflaRx. "The Phase III study builds on our promising Phase II clinical results, and we look forward to the continual collaboration with external experts with the ultimate goal of helping patients that are suffering from this devastating condition." The Phase III clinical study is designed to enroll patients worldwide, including countries such as the U.S., countries in Europe, and Australia. The multi-national, randomized, double-blind, placebo-controlled trial has two arms: one arm receiving vilobelimab plus a low dose of corticosteroids and another arm receiving placebo plus the same low dose of corticosteroids. In both arms, corticosteroid treatment will be initiated on day 1 and will be tapered off within the first 8 weeks of the trial. The primary endpoint of the study is complete closure of the target ulcer at any time up to 26 weeks after initiation of treatment.
Autolus Therapeutics reported Q3 EPS of (26c), consensus (25c), Q3 revenue of $406K, consensus $450K. Autolus estimates that its current cash and cash equivalents on hand and anticipated future milestone payment from Blackstone will extend the company's cash runway into 2025.
Seres Therapeutics reported Q3 EPS of (37c), consensus (50c), and Q3 revenue $310K, consensus $1.87M.The company also announced that it will pursue a strategic restructuring to focus its business operations to prioritize the commercialization of VOWST and the completion of the SER-155 Phase 1b study, while significantly reducing costs and supporting longer-term business sustainability. The company expects the restructuring, which includes a reduction in the current workforce of 41%, to result in annual cash savings of approximately $75M-$85M in 2024, excluding any one-time charges primarily associated with the workforce reduction.
Geron reported Q3 EPS of (8c), consensus (10c), and Q3 revenue $164K, consensus $60K ."This quarter, we continued to make important progress and build momentum along our planned path to develop and commercialize imetelstat, which is now the first telomerase inhibitor to be under review by both the FDA and EMA for potential regulatory approval," said CEO John Scarlett, M.D. "We see lower risk MDS as a very compelling commercial opportunity, with few durable treatment options and significant need for large patient segments such as patients without sideroblasts (RS-) and those with high transfusion burden. We believe, if approved, that imetelstat could play a meaningful role in this treatment landscape."
Plus Therapeutics reported Q3 EPS of ($1.00), consensus ($1.12), and Q3 revenue of $1.24M, consensus $1.29M. Additionally, Plus Therapeutics announced that its board approved a share repurchase program, with authorization to repurchase up to $500K of the company's outstanding common stock.
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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.