Norovirus sickens hundreds of millions of people around the world each year, sparking infection that causes a range of gastrointestinal problems and dehydration that can become deadly in the very young and the very old. There is no norovirus vaccine but HilleVax is working on what it believes can become the first one. Nine months after spinning out of Takeda Pharmaceutical, the young biotech company now has $200 million in IPO cash for clinical trials.
HilleVax initially planned to offer nearly 10.3 million shares priced in the range of $16 and $18 each. The Boston-based company ended up boosting the deal size to nearly 11.8 million shares priced at the $17 midpoint. Those shares began trading Friday on the Nasdaq under the stock symbol “HLVX.” Despite the dismal market for IPOs this year, HilleVax shares showed some pop and finished their first trading day at $19.09 apiece, a more than 12% bump up from the IPO price.
Though vaccine technology can address many viruses, norovirus has been a particular challenge. This virus is difficult to culture in the lab, which in turn makes it difficult to measure virus neutralization after infection or vaccination. That limitation makes it hard to develop vaccines from live virus that has been attenuated, or weakened, which is a conventional way of making many vaccines, such as those for influenza.
HilleVax’s norovirus vaccine candidate, HIL-214, uses virus like particles (VLPs), self-assembling structures that mimic the features and characteristics of the surface of a virus without using any live virus. By showing the immune system something that looks like norovirus, these vaccines are intended to prompt an immune response without the risk of causing infection. That’s because a VLP contains no viral genetic material so it cannot replicate. The technology also offers production advantages as these particles can be manufactured at scale.
VLP vaccines are already available. Merck’s Gardasil and GlaxoSmithKline’s Cervarix, both human papillomavirus vaccines, are made with VLPs. These particles are also being tested in other types of viruses, including Covid-19. Icosavax has reached the clinic with its VLP vaccine for the novel coronavirus, though that company reported disappointing data for the candidate a month ago. Companies pursuing VLP vaccines for norovirus include two Chinese firms, China National Biotec and Chongqing Zhifei Biological, according to the HilleVax prospectus. Icon Genetics and Vaxart are also pursuing norovirus vaccines.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
HIL-214 was originally developed by LigoCyte Pharmaceuticals, a biotech that Takeda acquired in 2012 for $60 million up front. Last summer, Takeda and Frazier Healthcare Partners launched HilleVax to continue HIL-214’s development. HilleVax has the right to develop and commercialize the vaccine globally, with the exception of Japan, where Takeda retains the rights. Takeda said that spinning out the asset enables the pharma giant to focus on vaccines for dengue, Covid-19, pandemic influenza, and Zika.
Last September, HilleVax signaled its plans to go public with a $135 million crossover financing round led by Frazier. That firm remains HilleVax’s largest shareholder with a 22.4% post-IPO stake, according to the prospectus. Takeda owns 18.6% of HillleVax after the IPO. The filing shows HilleVax had $124.5 million in cash at the end of 2021. Combined with the IPO cash, the company said it plans to spend about $125 million on clinical development of its norovirus vaccine, including manufacturing.
Under Takeda, the norovirus VLP vaccine completed a placebo-controlled Phase 2b study enrolling 4,712 adults. The results showed the shot was well tolerated by patients and it demonstrated the ability to prevent moderate-to-severe acute gastroenteritis from norovirus infection. The vaccine’s investigational new drug application was transferred from Takeda to HilleVax last September. The biotech said in its prospectus that it plans to start a Phase 2b study in infants later in the current quarter. Preliminary data are expected in the second half of next year. The company estimates that its cash will last for the next two years.
Belite Bio brings in $36M for eye drug’s clinical trials
Clinical-stage Belite Bio made its public markets debut Friday, raising $36 million for its small pipeline of eye drugs. Cayman Islands-based Belite priced its offering of 6 million American depositary shares at $6 apiece, which was the midpoint of the $5.50 to $6.50 per share range the biotech had planned. Belite shares began trading Friday on the Nasdaq under the stock symbol “BLTE.” Shares closed at $10.59 apiece, a 76.5% jump from the IPO price.
Belite is a subsidiary of Lin BioScience, a publicly traded company based in Taiwan. According to Belite’s prospectus, Lin Bio established Belite Bio Holdings in 2016 along with a limited liability company called Belite Bio. That unit is responsible for R&D of two Lin Bio assets, LBS-008 and LBS-009.
LBS-008, also known as Tinlarebant, is Belite’s lead drug candidate. The drug is in development as a treatment for two eye diseases: the dry form of age-related macular degeneration (AMD), which is a deterioration of a part of the retina called the macula, and Stargardt disease, a rare inherited disorder in which fatty material builds up on the macula. According to the prospectus, the drug, a small molecule, is based on technology licensed from Columbia University and assigned to the company by Lin Bio, which remains the biotech’s principal shareholder. LBS-009 is a preclinical small molecule in development for liver diseases.
So far, LBS-008 has been tested in Phase 1 studies in healthy volunteers and in an open-label Phase 1b/2 study in Stargardt patients. As of the end of last year, Belite reported its cash position was $17.4 million. With the new capital, the biotech plans to spend most of the money on further clinical development of the eye drug in dry AMD and a smaller amount on a planned pivotal study in Stargardt disease.
Bausch + Lomb plans $788M IPO in return as a standalone company
Eye health products Bausch + Lomb set financial terms for an IPO that would make it a standalone company again, spinning out from Bausch Health Companies. According to the updated prospectus, the Vaughan, Ontario-based firm plans to offer 35 million shares priced in the range of $21 and $24 apiece. At the $22.50 per share midpoint, the that stock offering would raise nearly $788 million, making it one of the biggest IPOs of the year.
Bausch + Lomb, a brand that spans more than 400 products sold in about 100 countries, initially filed its IPO plans in January. The company, which was acquired by Valeant Pharmaceuticals (since renamed Bausch Health) in 2013, might be best known for contact lens products but it divides its operations into three segments. The Vision Care/ Consumer Health Care segment includes the contact lens products. The other two segments are Ophthalmic Pharmaceuticals and Surgical. Those three business units produced more than $3.7 billion in revenue in 2021, a 10% increase over the prior year, according to the prospectus. Bausch + Lomb plans a dual listing on the Toronto Stock Exchange and the New York Stock Exchange, trading on both under the stock symbol “BLCO.”
Public domain image by the Centers for Disease Control and Prevention
