Most of the biggest biotech stocks on the market started off as unknown penny stocks. Look at Axsome Therapeutics (NASDAQ:AXSM), for example. At one time, it was a $2.50 stock. Now it’s up to $71 with a treatment for major depressive disorder. Fate Therapeutics (NASDAQ:FATE) once traded at less than $2.50, and ran to more than $114. Novavax (NASDAQ:NVAX) once traded around $3. All of them started small, but their strong pipelines didn’t let them stay cheap for long. In fact, find a biotech with hot data, an innovative way to treat an unmet medical need, or favorable reviews from the FDA, and you may just find the next big runner.
However, remember, that biotech penny stocks can be risky. As noted by the U.S. Securities and Exchange Commission (SEC), “Penny stocks may trade infrequently – which means that it may be difficult to sell penny stock shares once you have them. Because it may also be difficult to find quotations for penny stocks, they may be impossible to accurately price. Investors in penny stock[s] should be prepared for the possibility that they may lose their whole investment.”
So, I always ask that you never risk more than you can afford to lose. As long as you understand the risks, here are some top biotech penny stocks I’d consider throwing a few dollars into.
Cue Biopharma (CUE)
Cue Biopharma (NASDAQ:CUE) is a clinical-stage biopharmaceutical company that’s trying to bring a new class of immunotherapies to those impacted by cancer. In fact, according to the company, only a small fraction of patients – about 15% to 20% — will respond to current treatments. To reach a higher population of patients, Cue is working on injectable biologic drugs that are designed to selectively engage and modulate disease-specific T cells.
Most recently, the company received FDA acceptance of its Investigational New Drug (IND) application for CUE-102 in Wilms’ Tumor 1 (WT1)-expressing cancers and initiated dosing in a Phase 1 dose escalation monotherapy trial at 1mg/kg.
It was also granted Fast Track Designation for CUE-101 for the treatment of HPV+ recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a monotherapy and in combination with pembrolizumab.
Sana Biotechnology (SANA)
Keep an eye on Sana Biotechnology (NASDAQ:SANA). Just days ago, the company said SC451 – a pancreatic cell therapy to treat Type 1 diabetes – avoided allogenic and autoimmune rejections in mice.
According to Sana President and CEO Steve Harr, Science Translational Medicine published a paper “…demonstrating that hypoimmune pseudo islets developed with our hypoimmune technology survived and were able to reverse diabetes without any immunosuppression in humanized mice. Eliminating the need for insulin administration and reversing diabetes with normalization of blood glucose levels, and doing this without immunosuppression, would be a transformational advance for patients.”
Then, its SC262 – a hypoimmune-modified allogenic CD19-directed CAR-T cell therapy – was found to avoid immune detection and kill off tumor cells.
After slipping from $2.40 to a low of 81 cents, Precigen (NASDAQ:PGEN) is showing signs of life again. Now trading at $1.16, it’s being bid higher after its UltraCAR-T platform showed anti-tumor efficacy in preclinical data.
As noted by TheFly.com, “In two different in vivo xenograft models, a single administration of next generation MSLN UltraCAR-T cells to tumor bearing mice resulted in robust UltraCAR-T cell expansion and durable persistence leading to significant antitumor efficacy.”
Atossa Therapeutics (ATOS)
The FDA just authorized Atossa Therapeutics’ (NASDAQ:ATOS) EVANGELINE study, a Phase 2 trial of Z-endoxifen and Exemestane + Goserelin as neoadjuvant treatment in premenopausal women with ER+/HER2- breast cancer. “While there are several FDA-approved neoadjuvant therapies for ER-breast cancers, few exist for ER+ patients, which account for approximately 78% of breast cancers. We expect to enroll approximately 175 patients at up to 25 sites across the United States,” as noted in a company press release.
The company just recently dosed the first patient. Any positive outcome could send ATOS stock screaming higher.
BioLine RX (BLRX)
BioLine RX (NASDAQ:BLRX) just announced the FDA acceptance of its APHEXDA (motixafortide) new drug application (NDA). This is for stem cell mobilization for autologous transplantation in multiple myeloma patients. There’s a PDUFA target date of Sept. 9.
Even better, BLRX just announced the publication of data from its GENESIS Phase 3 clinical trial in the Nature Medicine journal, which “evaluated the safety and efficacy of the company’s lead investigational candidate motixafortide plus granulocyte colony-stimulating factor (G-CSF) versus placebo plus G-CSF for the mobilization of hematopoietic stem cells in patients with multiple myeloma prior to autologous stem cell transplantation (ASCT).”
These data highlighted the potential of motixafortide plus G-CSF, if approved, to enhance the treatment options for clinicians and patients with multiple myeloma undergoing ASCT.
Corvus Pharmaceuticals (CRVS)
Corvus Pharmaceuticals (NASDAQ:CRVS) just posted interim data demonstrating the potential of CPI-818, the company’s ITK inhibitor, for the treatment of T cell lymphoma (TCL).
“T cell lymphoma is a challenging disease to treat and there is a significant need for new approaches given the limited efficacy of current therapeutic options,” said John Reneau, MD, Ph.D., from The Ohio State University Comprehensive Cancer Center, and an investigator for the Phase 1/1b clinical trial of CPI-818 for TCL. “CPI-818 has a novel mechanism of action that includes the stimulation of normal T cells to infiltrate and destroy tumors. Our recent work indicates that the peripheral blood absolute lymphocyte count is a biomarker that may predict patients most likely to benefit from CPI-818.”
And finally, keep an eye on Ardelyx (ARDX), a biopharmaceutical firm going after first-in-class medicines to help meet significant unmet medical needs. The company just resubmitted its FDA New Drug Application (NDA) for approval of XPHOZAH (tenapanor) for the “control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy. The NDA is supported by a comprehensive development program that included more than 1,200 patients in three Phase 3 clinical trials evaluating the safety and efficacy of XPHOZAH, all of which met their primary and key secondary endpoints.”
Helping ARDX stock, Wedbush analyst Laura Chico upgraded Ardelyx to “outperform” from “neutral” with a price target of $6, up from $3. That’s thanks in part to XPHOZAH’s regulatory path becoming clearer, as noted by TheFly.com.
On Penny Stocks and Low-Volume Stocks: With only the rarest exceptions, InvestorPlace does not publish commentary about companies that have a market cap of less than $100 million or trade less than 100,000 shares each day. That’s because these “penny stocks” are frequently the playground for scam artists and market manipulators. If we ever do publish commentary on a low-volume stock that may be affected by our commentary, we demand that InvestorPlace.com’s writers disclose this fact and warn readers of the risks.
On the date of publication, Ian Cooper did not have (either directly or indirectly) any positions in the securities mentioned. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.