To put it mildly, 2021 was an exceptionally difficult year for public biotechs, with 80% of new issues reporting below their float price by the end of the year, according to Evaluate data.
But HilleVax threw caution to the wind Wednesday, filing for a $100 million IPO as it tests the public appetite for a single-asset company. It’s riding the wave of its norovax candidate, which has so far impressed in clinical trials. Immunogenicity data among 2,200 people found that it boosted antibody response more than eightfold above baseline. In a trial of more than 4,700 military recruits, the jab demonstrated 62% efficacy against acute gastroenteritis due to the virus. The efficacy jumped to 80% in preventing acute gastroenteritis from norovirus strains targeted with the vaccine.
Next on the docket for the company is launching a phase 2 clinical trial in infants, slated to start in the second quarter of 2022 with interim safety data coming in the second half of the year, interim immunogenicity data expected in the first half of 2023 and, finally, top-line results in the second half of next year. The company said that based on the phase 2 data in infants, it will launch into additional trials in older children and adults.
HilleVax spun out of Takeda less than a year ago, with the Japanese Big Pharma handing over the reins to its norovax candidate and global commercial rights everywhere except Japan. In September 2021, it raised $135 million in a crossover financing.
But the company will need to be careful given the treacherous landscape, particularly for companies with small to midsize market caps. Last year, Evaluate data revealed two-thirds of companies in those categories ended the year in the red.
Since launching, the company has been able to stack top brass onto its board, including former Centers for Disease Control and Prevention Director Julie Gerberding, M.D., who currently serves as chief patient officer at Merck. The company’s CEO, Robert Hershberg, M.D., Ph.D., is a venture partner at Frazier Healthcare Partners, which led the financing last year. Prior to joining Frazier Healthcare, Hershberg worked at Celgene, ascending to chief scientific officer and subsequently EVP and head of business development and global alliances before Bristol Myers Squibb bought the company.
As HilleVax makes its case to Wall Street, it says the total market for its shot could exceed $4 billion. For infants, it used rotavirus sales as a comparison, which notched $1.6 billion in global sales in 2020. Among older adults, the company compared the potential to Shingrix, which generated $2.7 billion in 2020.