After a almanac year for biotech IPOs in 2020, forecasts were bullish on another able year showing for public offerings — and 2021 hasn’t disappointed so far. Now, a clamp of four biotechs chasing attenuate disease and cancer and a New York SPAC are accessible to accompany the party.
Three added companies filed to arch to Nasdaq on Tuesday, as able-bodied as a SPAC, with an additional Dutch biotech filing Friday. All in all, early canicule indicate another big year, at atomic to start, with 12 companies either pricing or filing their IPOs in the aboriginal 20 canicule of January.
Biotech still has a continued way to go to ability the chart-topping 81 IPOs recorded aftermost year and $13.5 billion raised. But actuality are the newest companies helping get the industry off to a hot start.
A little over a anniversary after discovering a new CAR-T candidate, the Chinese biotech Adagene is shooting to go public.
Adagene’s CAR-T for renal corpuscle carcinoma is the aboriginal the biotech’s acquainted of to target a human endogenous retrovirus expressed in the majority of clear-cell kidney tumors. And on the aback of added than $150 million in fundraising, including a $69 million Series D aftermost 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, arch of the Laboratory of Transplantation Immunotherapy. The NIH is expected to booty over manufacturing and clinical development.
Regardless of how abundant banknote it ends up raising, Adagene said in its S-1 it affairs to allocate 95% of funds to R&D. The company will direct 26% of funds toward its advance 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 accepted 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 aboriginal and only CTLA-4 inhibitor Yervoy, also approved developing a 4-1BB agonist antibody dubbed urelumab, but hopes for a monotherapy were abject after liver toxicities emerged.
The aftermost 43% allocated to R&D will advice armamentarium preclinical candidates and further platform development, Adagene said. — Max Gelman
A couple months after nabbing $80 million in venture cash, Netherlands-based Pharvaris has penciled in a $100 million jump onto Nasdaq to aback its upstart approach for the attenuate genetic condition hereditary angioedema (HAE).
Pharvaris’ advance program, an inhibitor and selective small-molecule bradykinin B2-receptor antagonist, is in development as an articulate 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 articulate delivery, to provide patients with quality of activity 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 casting of veterans from Jerini, the biotech that originally developed Firazyr. Aback in November, the company released Phase I data from 16 advantageous volunteers it said suggest their molecule is 24 times added potent than Firazyr.
HAE is characterized by aching abscess in hands, anxiety and occasionally in the airways or intestinal walls. Attacks are unpredictable, and accept multiple triggers. Patients experience a median of 14 attacks per year, and bisected experience potentially life-threatening airway attacks at atomic already in their lifetime, Pharvaris said, citing scientific publications.
The company is launching two Phase II trials, one for prophylaxis and one for treating astute pain. If those are successful, they’ll follow up with pivotal Phase III studies. They plan on reading out Phase II data for the astute patients in 2022.
Viking Global Investors and General Atlantic, which led the Series C, authority aloof over 6.03% of shares each, according to the F-1. Modig has a 5.27% stake. — Nicole DeFeudis
NexImmune has maintained a relatively low profile after completing its $23 million Series A way aback in 2018. But now the Gaithersburg, MD-based biotech has two programs in the clinic and affairs to go public with an estimated $86 million raise.
The company was spun out of Johns Hopkins and centers about the abstraction of specialized nanoparticles that act as antigen-presenting beef to incite a T corpuscle attack on tumors. NexImmune’s ultimate ambition is to provide a added abiding attack involving added targets and beneath likelihood of a setback for patients, particularly if they can accomplish an impact on naïve and memory T beef to accumulate the human immune system on alert.
Within its S-1, NexImmune said the IPO funds will go toward its two advance 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 abstraction in astute myeloid leukemia, with initial results presented aftermost ages at ASH. Among the two dozen or so patients, the candidate was apparent 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 aboriginal patient in a Phase I/II abstraction in multiple myeloma aftermost October. — Max Gelman
Second time’s the agreeableness for Biophytis. The French biotech previously filed an F-1 aback 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 chain begins to booty shape, Biophytis is aback — penciling in another $15 million accession for its Nasdaq debut.
If successful this time around, Biophytis affairs on funneling best of the IPO funds into its advance program: a baby molecule dubbed Sarconeos, which the biotech believes can amusement sarcopenia, Duchenne Muscular Dystrophy (DMD), and alike 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 accepted to control things like fluid balance, claret 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 accumulation strength, balance and the ability to angle or airing — and for which there’s no approved treatment or widely accepted standard of care, Biophytis said. The candidate is currently in a Phase II abstraction for that indication, with topline results coming in Q2 this year.
The articulate biologic is also in Phase II/III for Covid-19 patients with pneumonia, with the aboriginal interim analysis scheduled for Q1. If all goes well, Biophytis says it could book for emergency use with the FDA and EMA in Q2.
“Most people infected with the COVID-19 virus will experience balmy to moderate respiratory illness and recover without requiring special treatment,” the F-1 states. Biophytis is looking to advice “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 aftermost month, and hopes to barrage a “seamless” clinical trial — one that combines multiple phases into an adaptive abstraction — in the aboriginal bisected 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
A new SPAC has emerged, and it’s being led by the CEO of a baby New York City biotech.
The bare analysis company is alleged FoxWayne Enterprises Acquisition and seeks to reverse absorb with a company following a $50 million raise. Robb Knie, CEO of Hoth Therapeutics, is leading the allegation by offering 5 million shares at $10 apiece.
FoxWayne originally filed its S-1 aback in December and submitted its 8-A aftermost week. The filings were accepted Tuesday. — Max Gelman
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