A stem cell biotech, a liver disease specialist and a gene therapy company have all got in the conga line for the biotech IPO boom.
Phase 3 stem cell transplantation biotech Talaris Therapeutics (once known as Regenerex until a name change two years ago) wants $100 million, as too does U.K.-based biotech Gyroscope Therapeutics, while liver disease and cancer biotech Sagimet Biosciences wants a slightly more modest $75 million.
All made their filings public Friday as they look to join the ever-growing march of biotechs going public and ride the wave of optimism the sector is currently bringing amid a depressed pandemic market.
First up is late-stage Talaris, a cell therapy biotech working on hematopoietic stem cell transplantation it wants to use to shake up the current standard of care in solid organ transplantation, certain severe autoimmune diseases and certain severe non-malignant blood, immune and metabolic disorders, according to its filing with the Securities and Exchange Commission (SEC).
Its platform is set up to try and stop organ rejection “without the morbidity and mortality that has been associated with the use of lifelong anti-rejection medicines.” Its leading asset is FCR001, an allogeneic cell therapy comprised of stem and immune cells that are procured from a healthy donor, who is also the organ donor in the case of organ transplantation.
The biotech is currently enrolling patients in FREEDOM-1, a randomized, controlled, open-label phase 3 registration trial in the U.S. for FCR001 in 120 adult living donor kidney transplant recipients. The goal of this trial is to evaluate the potential of FCR001, when administered the day after the kidney transplant, to induce durable, drug-free immune tolerance in the recipient of the transplanted kidney.
Inducing durable immune tolerance to a transplanted organ without the morbidities associated with lifelong immunosuppression is a goal that has been broadly referred to in the transplant field as the holy grail of solid organ transplant. It plans to list on the Nasdaq under the ticker "TALS."
Gyroscope Therapeutics, meanwhile, is focused gene therapies, notable in eye disorders, as it has also filed an IPO it hopes can raise $100 million. The Hertfordshire, U.K.-based company was founded in 2016 and is looking to tap the promise of a gene therapy approach to cure blindness, initially focusing on age-related macular degeneration (AMD).
It has a pipeline of recombinant adeno-associated virus gene therapy candidates with its leading therapy, GT005, in a midstage test for two different genetically defined patient populations with geographic atrophy, an advanced form of dry AMD. It too wants to list on the Nasdaq, under the symbol "VISN."
Gyroscope is taking a different approach to the treatment of eye disease from many of its gene therapy peers. Rather than use the modality to correct genetic causes of disease, The biotech is trying to increase production of complement factor I (CFI). As CFI down-regulates the complement system, Gyroscope is betting increasing production of the serine protease can counter a driver of AMD disease pathogenesis.
Its IPO attempt comes less than a month after it got off a $148 million funding round.
And last but not least is Sagimet Biosciences, a phase 2 biotech developing selective FASN inhibitors for liver diseases and cancers as it looks to raise $75 million on the Nasdaq under the ticker "SGMT."
Its leading med, TVB-2640, works as an oral, once-daily pill, which has been in early tests for non-alcoholic steatohepatitis (NASH) and cancer. In its FASCINATE-1 phase 2a clinical trial, TVB-2640 demonstrated statistically significant improvements across steatosis, inflammation/lipotoxicity, fibrosis and metabolic biomarkers important in NASH and was well-tolerated, the biotech said in its SEC filing.
“We believe that these attributes provide TVB-2640 the potential to treat a broad range of patients in this multifactorial disease.”
In the second quarter of 2021, it is plotting the FASCINATE-2 phase 2b for NASH patients with moderate to advanced fibrosis to see how well TVB-2640 can help with disease improvement by assessing liver biopsies after 52 weeks of treatment.
Within oncology, for the second half of 2021, it is slated to start a randomized, controlled phase 2 test for glioblastoma multiforme and a phase 1b/2 basket trial in several solid tumors where FASN inhibition “may have promising utility.”
It will also push on with its second FASN inhibitor, TVB-3567, in a first-in-human trial in the second half of this year.