The IPO flood keeps rising with 4 more biotechs and a SPAC on their way to Nasdaq

24 Jan 2021
endpts.com
AntibodyImmunotherapySmall molecular drugAcquisitionIPO
After a record year for biotech IPOs in 2020, forecasts were bullish on another strong year showing for public offerings — and 2021 hasn’t disappointed so far. Now, a clutch of four biotechs chasing rare disease and cancer and a New York SPAC are ready to join the party. Three more companies filed to head to Nasdaq on Tuesday, as well as a SPAC, with an additional Dutch biotech filing Friday. All in all, early days indicate another big year, at least to start, with 12 companies either pricing or filing their IPOs in the first 20 days of January. Biotech still has a long way to go to reach the chart-topping 81 IPOs recorded last year and $13.5 billion raised. But here are the newest companies helping get the industry off to a hot start. China’s Adagene looks to index new HERV-based CAR-T A little over a week after discovering a new CAR-T candidate, the Chinese biotech Adagene is shooting to go public. Adagene’s CAR-T for renal cell carcinoma is the first the biotech’s aware of to target a human endogenous retrovirus expressed in the majority of clear-cell kidney tumors. And on the back of more than $150 million in fundraising, including a $69 million Series D last January, Adagene is penciling in $125 million for their IPO raise. Adagene’s candidate was developed in tandem with the NHLBI in the lab of Richard Childs, chief of the Laboratory of Transplantation Immunotherapy. The NIH is expected to take over manufacturing and clinical development. Regardless of how much cash it ends up raising, Adagene said in its S-1 it plans to allocate 95% of funds to R&D. The company will direct 26% of funds toward its lead candidate, ADG106, a monoclonal antibody and CD137 agonist, which is currently in Phase Ib/IIa trials for advanced or metastatic solid tumors and/or relapsed/refractory non-Hodgkin’s lymphoma. Another 26% of funds are slated to go toward Adagene’s other two programs, ADG116 and ADG126. Both programs seek to block the known cancer target CTLA-4, with ADG116 focusing on a “unique” epitope. The former has started a Phase I in advanced metastatic solid tumors while the latter hasn’t yet hit the clinic. Bristol Myers Squibb, which pioneered the first and only CTLA-4 inhibitorCTLA-4 inhibitor Yervoy, also tried developing a 4-1BB agonist antibody dubbed urelumab, but hopes for a monotherapy were dashed after liver toxicities emerged. The last 43% allocated to R&D will help fund preclinical candidates and further platform development, Adagene said. — Max Gelman Pharvaris pencils in $100 million raise to back oral HAE approach A couple months after nabbing $80 million in venture cash, Netherlands-based Pharvaris has penciled in a $100 million jump onto Nasdaq to back its upstart approach for the rare genetic condition hereditary angioedema (HAE). Pharvaris’ lead program, an inhibitor and selective small-molecule bradykinin B2-receptor antagonist, is in development as an oral alternative to currently available HAE treatments — like CSL’s Haegarda and Takeda’s Cinryze, Takhzyro and Firazyr, which are all injectable. “We designed PHA121 to improve upon the therapeutic profile of existing therapies and, through oral delivery, to provide patients with quality of life and convenience that is superior to current standard-of-care HAE treatments, which are injectables,” the F-1 states. The biotech was founded by Berndt Modig, now CEO, and a cast of veterans from Jerini, the biotech that originally developed Firazyr. Back in November, the company released Phase I data from 16 healthy volunteers it said suggest their molecule is 24 times more potent than Firazyr. HAE is characterized by painful swelling in hands, feet and occasionally in the airways or intestinal walls. Attacks are unpredictable, and have multiple triggers. Patients experience a median of 14 attacks per year, and half experience potentially life-threatening airway attacks at least once in their lifetime, Pharvaris said, citing scientific publications. The company is launching two Phase II trials, one for prophylaxis and one for treating acute pain. If those are successful, they’ll follow up with pivotal Phase III studies. They plan on reading out Phase II data for the acute patients in 2022. Viking Global Investors and General Atlantic, which led the Series C, hold just over 6.03% of shares each, according to the F-1. Modig has a 5.27% stake. — Nicole DeFeudis On the heels of ASH, NexImmune guns for $86 million IPO raise NexImmune has maintained a relatively low profile after completing its $23 million Series A way back in 2018. But now the Gaithersburg, MD-based biotech has two programs in the clinic and plans to go public with an estimated $86 million raise. The company was spun out of Johns Hopkins and centers around the idea of specialized nanoparticles that act as antigen-presenting cells to incite a T cell attack on tumors. NexImmune’s ultimate goal is to provide a more durable attack involving more targets and less likelihood of a setback for patients, particularly if they can make an impact on naïve and memory T cells to keep the human immune system on alert. Within its S-1, NexImmune said the IPO funds will go toward its two lead programs, NEXI-001 and NEXI-002 that focus on donor-derived and patient-derived T cells, respectively. NEXI-001 is in an ongoing Phase I/II study in acute myeloid leukemia, with initial results presented last month at ASH. Among the two dozen or so patients, the candidate was shown to induce a return to baseline levels of absolute lymphocyte counts within 3 to 35 days. The program is still in its early clinical days, however. There haven’t been any readouts for NEXI-002 yet, but NexImmune dosed the first patient in a Phase I/II study in multiple myeloma last October. — Max Gelman Biophytis takes a second shot at a Nasdaq debut Second time’s the charm for Biophytis. The French biotech previously filed an F-1 back in May 2019, penciling in a $15 million hop onto Nasdaq. But it withdrew later that July due to “unfavorable market conditions.” Now, as the 2021 IPO queue begins to take shape, Biophytis is back — penciling in another $15 million raise for its Nasdaq debut. If successful this time around, Biophytis plans on funneling most of the IPO funds into its lead program: a small molecule dubbed Sarconeos, which the biotech believes can treat sarcopenia, Duchenne Muscular Dystrophy (DMD), and even SARS-CoV-2 pneumonia. Sarconeos is designed to activate the MAS receptor in muscle cells, a key component of the Renin-angiotensin system (RAS) — an endocrine system known to control things like fluid balance, blood pressure, cardiovascular function and smooth, cardiac and skeletal muscle metabolism. By activating the MAS receptor, Sarconeos triggers two downstream signaling pathways in myocytes that are impaired in muscle-wasting conditions, according to Biophytis. The initial target indication is sarcopenia, the age-related degeneration of skeletal muscle that leads to muscle mass strength, balance and the ability to stand or walk — and for which there’s no approved treatment or widely accepted standard of care, Biophytis said. The candidate is currently in a Phase II study for that indication, with topline results coming in Q2 this year. The oral drug is also in Phase II/III for Covid-19 patients with pneumonia, with the first interim analysis scheduled for Q1. If all goes well, Biophytis says it could file for emergency use with the FDA and EMA in Q2. “Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment,” the F-1 states. Biophytis is looking to help “older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease and cancer,” who are “more likely to develop serious illness.” The company also snagged IND approval for a Phase I/II trial in DMD last month, and hopes to launch a “seamless” clinical trial — one that combines multiple phases into an adaptive study — in the first half of 2021, according to the F-1. Stanislas Veillet, Biophytis’ co-founder and CEO who hails from Danone and Monsanto, owns 4% of the company’s stock. —Nicole DeFeudis CEO of small NYC biotech heads up $50 million SPAC A new SPAC has emerged, and it’s being led by the CEO of a small New York City biotech. The blank check company is called FoxWayne Enterprises Acquisition and seeks to reverse merge with a company following a $50 million raise. Robb Knie, CEO of Hoth Therapeutics, is leading the charge by offering 5 million shares at $10 apiece. FoxWayne originally filed its S-1 back in December and submitted its 8-A last week. The filings were accepted Tuesday. — Max Gelman
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