9 Smaller Biotechs in the Spotlight for Next Week's Q3 Reports
Plenty of biotech companies will be releasing their third-quarter financial reports next week. Let’s take a quick look at some of these companies and their top stories they reported through 3Q2018.
Monday, November 12
UroGen – Based in New York, UroGen is a clinical-stage biopharma company focused on developing drugs for urological diseases, with a particular focus on uro-oncology. In September, the company appointed Jones “Woody” Bryan as senior vice president of Business Development. He previously was SVP of Business Development at Sucampo Pharmaceuticals. On October 30, the Food and Drug Administration (FDA) granted the company Breakthrough Therapy Designation to its lead candidate, UGN-101 (mitomycin gel). The drug is currently in Phase III clinical trials for patients with low-grade upper tract urothelial cancer.
Asterias Biotherapeutics – Headquartered in Fremont, Calif., Asterias focuses on cell-based therapeutics for neurological conditions linked to demyelination and cellular immunotherapies for cancer. On September 4, the company announced that the Safety Review Committee (SRC) for its first clinical trial of VAC2 had reviewed the safety and tolerability data to date in the trial and recommended continuation and to continue to open enrollment. VAC2 is being evaluated in non-small cell lung cancer (NSCLC). On October 31, it announced a positive outcome from an independent Data Review Panel’s review of data from its ongoing Phase I/IIa SCiStar trial. This trial is looking at OPC1 for treatment of severe cervical spinal cord injury. And, on November 8, it was announced that Asterias was merging with BioTime. Brian M. Culley, BioTime’s chief executive officer, said the acquisition of Asterias is part of the vision to build BioTime into a “premier cell therapy company.”
Moleculin Biotech – Houston-based Moleculin Biotech is an oncology company built on research from MD Anderson Cancer Center. On September 13, the company launched a Phase I clinical trial of WP1066, whose active ingredient is propolis, a natural product of honey bees. It is being evaluated in glioblastoma. Since then, the company has updated the progress of the trial, including a significant milestone on November 1, noting that bioavailability of the drug being observed in participating patients.
Precision Therapeutics – Much of the news this quarter for Minneapolis-based Precision Therapeutics has revolved around the formation of its Scientific Advisory Board. It named its first member, Marc Malandro, vice president of operations for Science at the Chan Zuckerberg Initiative. On September 27, the company announced its first European sales of the STREAMWAY System, an automated, direct-to-drain medical fluid disposal system sold by its Skyline Medical division. And on November 7, the company acquired the rights to technology for proprietary culture media to grow ovarian cancer cell types in the laboratory.
Myovant – Myovant has had a busy quarter (which for them is their second quarter). On October 8, the company partnered with Flo Health to create a digital tool to screen for heavy menstrual bleeding. Two days later, the company presented positive data from its Phase I clinical trial of MVT-602 as a potential treatment for female infertility in women. And on October 24, the company announced it had completed patient enrollment in its Phase III trial, HERO, to evaluate relugolix for men with advanced prostate cancer.
Urovant Sciences – Urovant is a sister company of Myovant, both under the Roivant Sciences umbrella. On August 28, the company announced it had licensed a novel gene therapy for patients with overactive bladder symptoms from Ion Channel Innovations. On September 24, Urovant announced that Kyorin Pharmaceutical’s vibegron had been approved in Japan for adults with overactive bladder. Kyorin licensed the drug for Japan from Merck & Co. in 2014, then later expanded that license to other Asian countries. Urovant licensed the rights to it for the U.S. and the rest of the world from a subsidiary of Merck. Then in 2017, it entered into a collaboration deal with Kyorin.
Tuesday, November 13
Rubius Therapeutics – Based in Cambridge, Mass., Rubius launched its initial public offering (IPO) on July 18, with an initial price of $23 per share. The company’s focus is on genetically engineered long-circulating Red-Cell Therapeutics (RCT) products. They are genetically engineered, enucleated red cells and have broad therapeutic applications for cancer, enzyme replacement therapy and autoimmune disease. The company raised $240 million in its IPO. On October 12, the company broke ground on its new pharmaceutical manufacturing facility in Rhode Island.
Jounce Therapeutics – Based in Cambridge, Mass., Jounce is a clinical-stage immunotherapy company focused on immuno-oncology. One thing the company is likely to mention at its third-quarter report is that its scientific founder, James P. Allison, won the 2018 Nobel Prize in Physiology or Medicine for the discovery of cancer therapy by inhibition of negative immune regulation. Otherwise, the company is presenting two posters from its JTX-2011 program at the Society for Immunotherapy of Cancer’s (SITC)'s 33rdAnnual Meeting being held November 9-11. JTX-2011 is a monoclonal antibody that binds to and activates the Inducible T Cell Co-Stimulatory (ICOS), on the surface of certain T-cells. It is being evaluated in a Phase II trial in solid tumors.
Wednesday, November 14
Aldeyra Therapeutics – Aldeyra focuses on immune-mediated diseases. Its lead product candidate is reproxalap, a first-in-class treatment in late-stage development for dry eye disease and other types of ocular inflammation. It also has candidates for autoimmune disease, post-transplant lymphoproliferative disease, retinal inflammation, metabolic disease, and cancer. The company announced a public offering of common stock on September 27, 2018 with a public offering price of $13.75.