Highlights:
Investing in small cap biotech stocks, while extremely risky, is appealing to investors who are willing to risk capital in the search for 10x and 20x returns.
When a small cap biotech company releases positive news, such as clearance for an investigative new drug or the results of topline clinical data, it is not uncommon for the underlying shares prices to triple or quadruple overnight as investors digest the positive news catalyst.
The life science sector consists of more than 1,500 publicly traded companies in North America alone. Within this, there are more than 600 publicly traded biotechnology companies all developing new therapeutics to address unmet needs.
Here are five biotech companies trading under $5 per share that have had recent market moving news:
1. SELLAS Life Sciences (NASDAQ: SLS)
SELLAS Life Sciences, a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, recently announced positive topline data for the cohort of patients with acute myeloid leukemia from its Phase 1 dose-escalation trial in relapsed/refractory myeloid malignancies for GFH009, its CDK9 inhibitor.
The company said that during Phase 1 interim analysis, 72 patients with advanced blood cancer who were high-risk, heavily treated, and resistant to prior therapies were included in the study's acute myeloid leukemia and lymphoma cohorts. The study tested two dosing regimens, with incremental GFH009 dose levels ranging from 2.5 mg to 75 mg, either using a twice-weekly regimen or a once-weekly regimen.
Out of the 94% of patients still alive to date, 29 out of 31 patients in the acute myeloid leukemia cohort and 39 out of 41 patients in the lymphoma cohort have shown positive results. One patient is still alive more than 18 months after the start of treatment. No further dose escalations are planned for the AML cohort.
SELLAS said that the results were highly encouraging and that novel agents for relapsed acute myeloid leukemia are in high demand. The company plans to release full acute myeloid leukemia data as well as lymphoma topline data in late 2023.
Shares of SELLAS Life Sciences trades on the NASDAQ under the ticker symbol SLS.
2. Tonix Pharmaceuticals (NASDAQ: TNXP)
Clinical-stage biopharmaceutical company Tonix Pharmaceuticals was recently granted clearance by the FDA for its investigational new drug application to proceed with a Phase 1 clinical trial for the company’s TNX-1500 humanized monoclonal antibody.
The new drug application for TNX-1500 was supported by preclinical allotransplantation studies conducted at the Massachusetts General Hospital.
The company says that TNX-1500 is a third generation anti-CD40L monoclonal antibody that has been designed by protein engineering to decrease FcγRIIA binding and reduce the potential for thrombosis. Preclinical studies in non-human primates demonstrated that TNX-1500 showed activity in preventing allograft organ rejection and was well tolerated.
Tonix is planning to begin enrollment for the Phase 1 study during Q3 2023.
Shares of Tonix Pharmaceuticals trade on the NASDAQ under the ticker symbol TNXP.
3. Immunic (NASDAQ: IMUX)
Immunic, a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, recently presented clinical and preclinical data for IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6, a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium.
The company says that in both animal and early clinical studies, IMU-856 has been shown to restore and renew the intestinal lining. In a preclinical dextran sodium sulfate colitis model, IMU-856 treatment protected and also improved regeneration of the gut lining, as measured by normalization of crypt architecture.
Immunic is now preparing for Phase 2 clinical testing. The company trades on the NASDAQ under the ticker symbol IMUX.
4. Protalix BioTherapeutics (NYSEAMEX: PLX)
Shares of Protalix BioTherapeutics are trading higher after the company recently announced that the European Commission has granted marketing authorization to PRX-102 in the European Union for the treatment of adult patients with Fabry disease.
The company says that PRX-102 is a PEGylated enzyme replacement therapy to treat Fabry disease. It is a plant cell culture-expressed, and chemically modified stabilized recombinant version of the α–Galactosidase–A enzyme. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours.
The EC authorization of PRX-102 was based on results from a comprehensive clinical development program in more than 140 patients with up to 7.5 years of treatment. It has been studied in both ERT-naïve and ERT-experienced patients, including a head-to-head trial that met its primary endpoint, with PRX-102 demonstrating non-inferior efficacy to agalsidase beta in controlling kidney disease as evaluated by the estimated glomerular filtration rate (eGFR) decline.
Shares of Protalix BioTherapeutics trade on the NYSE American under the symbol PLX.
5. NLS Pharmaceutics (NASDAQ: NLSP)
NLS Pharmaceutics, clinical-stage biopharmaceutical company developing therapies for patients with rare and complex central nervous system disorders, recently announced that the FDA had provided authorization to proceed with Phase 3 clinical trials for its leading drug candidate Quilience®.
The company says that the new trial will encompass two double-blind Phase 3 trials investigating Mazindol ER versus placebo in adult patients with narcolepsy. NLS plans to commence the trials at multiple sites in the United States and will measure the weekly cataplexy episodes as the primary endpoint over eight weeks of treatment. Patients who complete the studies will also be offered participation in a 12-month open-label extension study.
NLS Pharmaceutics trades on the NASDAQ under the ticker symbol NLSP.
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These five companies are among hundreds of biotechnology companies researching and developing novel new treatments and drugs for various medical conditions.
Other biotech companies that trade under $5 per share include:
For a full list of all publicly traded biotechnology companies visit: https://healthstockshub.com/stocks/biotechnology-stocks
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