Six months after bagging $115 million in a Series B financing round, Talaris Therapeutics is aiming to raise another $100 million through in initial public offering. It’s one of three companies joining in the flurry of IPOs this week.
Six months after bagging $115 million in a Series B financing round, Talaris Therapeutics is aiming to raise another $100 million through in initial public offering. It’s one of three companies joining in the flurry of IPOs this week.
Kentucky-based Talaris filed a preliminary prospectus with the U.S. Securities and Exchange Commission announcing its intentions to begin trading shares on the Nasdaq under the ticker symbol “TALS.” The offering price range for the common stock shares were not disclosed in the preliminary filing.
Talaris’ lead asset FCR001 is an investigational allogeneic cell therapy aimed at living donor kidney transplant (LDKT) recipients. FCR001 was previously part of Novartis’ gene and cell therapy unit, until it was dissolved in 2016. The rights reverted back to Talaris, which at the time was known as Regenerex. Last year, after the company raised its Series B finances, Talaris CEO Scott Requadt told BioSpace that he sees FCR001 as a potential pipeline in a product, an experimental treatment that could have multiple uses across a number of indications. FCR001 has potential to help patients acquire or restore immune tolerance, which provides a number of opportunities for the drug.
“Our goal is to basically do for immune tolerance what CAR-T has done for oncology,” Requadt said in that earlier interview. “The same product and the same basic biology will be used. We can treat organ transplant and autoimmune diseases in the same manner.”
Talaris is currently enrolling patients in the Phase III FREEDOM-1 study, which will include 120 adult living donor kidney transplant (LDKT) recipients. The goal of the study is to evaluate FCR001 in patients who have received a kidney transplant to determine if the allogeneic therapy can induce durable, drug-free immune tolerance in the recipient. To be able to accomplish this is something of a “Holy Grail” for the transplant community. Patients who receive organs from others are required to take immunosuppressants for the rest of their life in order to prevent their body’s immune system from attacking the transplanted organ.
The primary endpoint of FREEDOM-1 is to evaluate the proportion of FCR001 treated recipients who are free from immunosuppression without biopsy-proven acute rejection at 24 months post-transplant. The secondary endpoint is to evaluate the change in renal function as measured by estimated glomerular filtration rate, which estimates how much blood passes through the filters in the kidney that remove waste from the blood.
In 2018, Talaris posted positive Phase II data in LDKT recipients, with 70% of patients who received the treatment able to discontinue the use of immunosuppressant drugs. The phase II data showed that every tolerized patient has been able to remain free of the use of chronic immunosupressants for up to 10 years.
Through FCR001, Talaris will be able to change the underlying pathology of the disease so the immune system no longer sees it as a threat, Requadt said.
In addition to kidney transplants, FCR001 is also being explored as a treatment for scleroderma, a multi-system autoimmune disease.
In addition to Talaris, London-based Gyroscope Therapeutics also plans to list on the Nasdaq. The company filed its F-1 with the SEC last week indicating it plans to raise at least $100 million in its IPO. The company intends to be sold under the ticker “VISN.”
Gyroscope is coming off a $148 million Series C raise. Proceeds from the Series C and the IPO will be used to advance GT005, the company’s investigational gene therapy being assessed for treatment of geographic atrophy secondary to age-related macular degeneration (AMD). In February, the company announced positive interim Phase II data that showed the asset provided sustained increases in vitreous Complement Factor I (CFI) levels in the majority of patients.
California-based Sagimet also filed for an IPO. The company, which is developing a therapeutic for nonalcoholic steatohepatitis (NASH), plans to raise $75 million in its IPO. In February, the company raised $80 million in a crossover financing.
