IPO tracker: After another three pricings bring total raise close to $3B, debuts expected to slow in short week
The Endpoints News team is continuing to track IPO filings for 2021, and we’re off to another hot start after 2020’s record year.
There have already been 16 biotechs to debut on the Nasdaq so far this year, with Sana leading the way. Its massive IPO raise, which was updated to more than $675 million after the underwriters exercised all their options, makes up the lion’s share of a combined $2.86 billion fundraise.
Coupled with the more than $700 million it raised while private, Sana went public with one of the largest valuations in the industry’s history and the largest-ever — $4.6 billion — for a company without any drugs yet to reach the clinic. Five other biotechs have also raised more than $200 million each, however, with Gracell, Cullinan, Bolt, Immunocore and Vor all topping the mark.
Three more companies tumbled onto the market last week, with NexImmune, Decibel and Biophytis all taking the leap. But while another small company filed its F-1 last Thursday — Protagenic Therapeutics, seeking an $18 million raise — there aren’t any expected pricings slated for this week.
That being said, we’ll still be keeping an eye on any companies who file their S-1s this week. Below, you’ll find the companies that have filed to go public, in addition to those that have already priced.
THE PITCH: THE S-1s THAT HAVE BEEN FILED
Chairman: Garo Armen
Estimated raise: $18 million
Snapshot: The small neuro disorder biotech Protagenic Therapeutics filed for an $18 million IPO last Thursday. Working on neuropeptides derived from the TCAP family, the company’s lead program PT00114 is being developed to treat stress-related disorders such as PTSD and drug and alcohol addictions without interfering with brain function. The compound is expected to complete IND-enabling studies in early 2021, and subsequently, enter Phase I/II trials. Protagenic said in its S-1 it plans to funnel money toward enrolling this “basket” trial, with the goal of signing up 42 patients. Ultimately, Protagenic’s goal is to improve mental health by counterbalancing stress overdrive and restoring the health of neuronal cells. Protagenic is already listed on the OTCQB market, with securities listed at $4.15 as of Feb. 12.
CEO: Mark McKenna
Estimated raise: $125 million
Snapshot: Just a few months after a $130 million crossover round, Prometheus is making the jump to the public market. Spun out of Cedars-Sinai Medical Center, the company built a considerable portion of its scientific foundation around the work of Stephan Targan, an IBD specialist who founded the IBD Center at the medical center about 30 years ago. Their lead program, PRA023, is an anti-TL1A antibody. Pfizer has a similar program, but McKenna has ambitions to build a broad pipeline around IBD. The crossover stretched Prometheus’ runway out to 2023, when McKenna hopes to have three to four programs either IND-ready or in the clinic. In the initial S-1, Prometheus is looking to fund development for PRA023 in ulcerative colitis and Crohn’s disease, as well as their PR600 program — an anti-TNF antibody slated right now as an IBD catch-all. McKenna hopes to complete a Phase II trial for the lead candidate and wrap up IND-enabling studies for PR600. Also included in the S-1 was a $1 million bonus for McKenna should he complete the IPO raise by March 9. That comes on top of an industry-standard $500,000 salary last year with $750,000 collected in performance bonuses.
CEO: Kevin Lind
Estimated raise: $86 million
Snapshot: Longboard is making the quick transition to a public company just a few months after spinning out as its own company. A former neuro subsidiary of Arena Pharma, Longboard came to life in October with $56 million in funding. The biotech was originally the brainchild of Arena CEO Amit Munshi, who arrived at JP Morgan in 2020 with ambitious plans, including launching this subsidiary. The company has three key programs in its pipeline, starting with LP352, a “next-generation,” clinical stage 5-HT2C agonist. It’s in development for developmental and epileptic encephalopathies, and the S-1 says Longboard wants to use the IPO funds to complete a planned Phase Ib/IIa trial in this space. Following up is LP143, an agonist of the cannabinoid type 2 receptor, and LP659, an S1P receptor modulator. Those two drugs are targeted at microglial neuroinflammatory diseases. Longboard is seeking to complete Phase I trials for both programs with the IPO money, per the S-1. Former CFO Kevin Lind was appointed as the new CEO back in October.
CEO: Eric Richman
Estimated raise: $40 million
Snapshot: Seeking a relatively modest raise given the run of biotechs over the last year or so to go after hefty IPO cash, Gain is shooting for just $40 million. The company focuses on protein misfolding, with an initial goal of treating lysosomal storage disorders. They have exclusively in-licensed a proprietary platform to accomplish this, and are targeting the GLB1 gene to create therapies for GM1 gangliosidosis and the GBA1 for Gaucher’s disease and Parkinson’s. It’s here where Gain will funnel its IPO funds, with the hope of pushing these candidates into Phase I/II trials for their respective indications. The company also has candidates that try to hone in on the IDUA gene in mucopolysaccharidosis type 1 and the GALC gene in Krabbe disease. Gain emerged from stealth last July with a $10 million Series B round, using that fundraise to set up two IND-enabling studies.
THE PRICE: COMPLETED IPOs
1. Gracell Biotechnologies
CEO: Wei William Cao
Raised: $209 million
Snapshot: The first biotech IPO of 2021, Gracell is moving a CAR-T therapy originating from China into the public eye. Gracell was built on two technologies: FasTCAR, which promises to shorten manufacturing turnaround time to 22-36 hours; and TruUCAR, its take on allogeneic CAR-T. Additionally, the company has its own production site in Suzhou to keep the key processes in-house. In its F-1 filing, Gracell reported that GC012F, its autologous CAR-T therapy targeting both BCMA and CD19, has treated 16 patients with relapsed/refractory multiple myeloma, and that 15 achieved and maintained a response. The highest dose cohort recorded a 100% stringent complete response rate for the six evaluable patients. Though it faces tough competition from well-funded US companies like Allogene, Lyell and even Sana, Gracell is plunging full speed ahead with a registrational trial in China that just got cleared and plans to start US trials in 2021.
2. Cullinan Oncology
CEO: Owen Hughes
Raised: $249.9 million
Snapshot: Cullinan investors aren’t buying into a single drug or platform, but instead a sort of umbrella with several different hot approaches to fighting cancer. The company works with a hub-and-spoke model much like BridgeBio, reserving individual assets in separate entities operating under the flagship. That way, execs can centralize R&D, BD and administrative work while betting on as many different approaches as possible. Cullinan has nine such projects under the umbrella, with the most recent program, known as Cullinan Amber announced last July. The whole operation’s first drug in the clinic is CLN-081 and the only targeted therapy in the mix, targeting NSCLC with EGFR exon 20 insertion mutations. Other tech approaches represented include bispecifics, NK cell-engaging antibodies, cytokine fusion protein, as well as TCR-based therapy. Cullinan filed for its IPO shortly after presenting what they called initial clinical data on CLN-081, and on the heels of announcing a $131 million Series C.
3. Sana Biotechnology
CEO: Steve Harr
Raised: $675.6 million
Snapshot: Harr’s team at Sana originally penciled in a $150 million raise, but they ended up with a much bigger figure, resulting in a roughly $4.6 billion valuation. Sana also sold all of its available options, taking its total raise about $90 million higher than when it first priced. That scale, which marked the highest market cap in history for a biotech without any programs in the clinic, has drawn comparisons to another Flagship startup in Moderna, which debuted at a $7.5 billion valuation and has soared on the backs of its Covid-19 vaccine to reach north of $50 billion. Sana’s lofty raise is based solely on the company’s animal data and the track records of its investors. As laid out in its S-1, Sana’s long-term goals are “to control or modify any gene in the body, to replace any cell that is damaged or missing, and to markedly improve access to cellular and gene-based medicines.” The company expects to file its first INDs in 2022 and 2023 and is researching a range of indications in in vivo and ex vivo settings, including non-Hodgkin lymphoma, multiple myeloma, and Type 1 diabetes. Sana has made big winners out of Bob Nelsen’s ARCH Ventures and Flagship, who will combine to own 43% of shares after the IPO closes. And they’re banking the company turns out to be a success story like Moderna — or perhaps something even bigger. The hype is real, as Sana closed up roughly 60% in its first day and a half of trading.
4. Landos Biopharma
CEO: Josep Bassaganya-Riera
Raised: $100 million
Snapshot: The lead company in the portfolio of Chris Garabedian’s fund with Perceptive, Landos did not impress on its last data dump. And since pricing at the midpoint late Wednesday night, Landos shares have since fallen about 31% from the IPO. In January, a Phase II proof-of-concept trial in its lead compound, BT-11, missed on all its primary endpoints in IBD despite “positive” signs it measured up with standard of care. Virginia Tech professor Josep Bassaganya-Riera has studied the pathway known as Lanthionine Synthetase C-Like 2 (LANCL2) for more than a decade, and BT-11 aims to leverage this research. Landos is preparing a Phase III trial for later this year, seeking to evaluate maintenance of clinical remission after a year following the 12-week induction period. BT-11 is one of three Landos compounds utilizing this pathway, with lead indications in ulcerative colitis and Crohn’s disease, and Landos also has plans for BT-11 in eosinophilic esophagitis, psoriasis and atopic dermatitis. The company has advanced a second program into the clinic in IBD as well, launching a Phase I study of NX-13 last July.
5. Sensei Biotherapeutics
CEO: John Celebi
Raised: $133 million
Snapshot: Formerly known as Panacea, Sensei had penciled in a $100 million raise for their bacteriophage-based cancer therapies and pulled in an upsized raise. Sensei is one of a few players applying the bacteriophages in the cancer space, though they’ve been studied for decades. Their lead candidate, SNS-301, is being studied in combination with Merck’s Keytruda for squamous cell carcinoma of the head and neck. The Phase I/II trial had enrolled 11 patients as of Dec 10, and 7 of the 10 evaluable patients saw some form of disease control. That included one patient with a partial response and two who achieved long-standing stable disease. Sensei expects to read out topline data by the end of 2021, which they hope will pave the way to a registration-enabling trial. This IPO push comes just a few months after Sensei raised $28.5 million in what they called a Series AA round. Sensei is also developing two preclinical candidates — SNS-401, a potential vaccine cocktail against Merkel cell carcinoma; and SNS-VISTA, an antibody-based therapeutic. With a market cap of about $640 million, Sensei shares have ticked up about 30% since pricing.
CEO: Bahija Jallal
Raised: $258 million
Snapshot: TCR pioneer Immunocore, pricing above its range with an upsized $258 million raise, revealed a promising set of pivotal interim data for their lead program tebentafusp back in November, and is aiming to use the IPO funds to finish a Phase III for the candidate in frontline cases of metastatic uveal melanoma. Researchers gathered 378 patients for the late-stage study, pitting the compound against investigators’ choice. There’s no approved therapy for this indication, so the choice tends to be between Keytruda or Yervoy, with some patients opting for dacarbazine instead. At the first planned interim readout for the intent-to-treat, all-comers patient population, Immunocore registered a hazard ratio of 0.51. Jallal told Endpoints News at the time that not only was this the first positive late-stage survival data for a TCR, but also the first positive Phase III snapshot for a bi-specific in a solid tumor, as well as the first such match-up against checkpoints. The company had previously raised more than $450 million, including a then-record European round of $320 million for their Series A in 2015. Immunocore was also the victim of an alleged “kickback” fraud in a scheme involving two third-party suppliers, The Times reported in late January. The company had also expected to raise an additional $15 million in private placement from the Bill and Melinda Gates Foundation at the same time as the IPO.
7. Bolt Biotherapeutics
CEO: Randy Schatzman
Raised: $230 million
Snapshot: Bolt had most recently raised $93.5 million in a Series C last July and raised an upsized $230 million after originally expecting a range of $16 to $18. The main idea is one that comes from the inventor of the first cancer vaccine, with a lead program in BDC-1001 they call an immune-stimulating antibody conjugate. Whereas the vaccine process involved extracting dendritic cells, exposing them to a protein from the patients’ own tumors and reinfusing them, Bolt is trying to directly activate dendritic cells around tumors without the need for removal. If it works, the candidate would turn the environment around the tumor from an immuno-suppressive to one that could not only kill the tumors once but prevent a recurrence. BDC-1001 entered a Phase I/II trial for patients with HER2-expressing solid tumors in the first quarter of 2020. It’s currently in a dose-escalation stage, and is expected to move into Phase II dose expansions this year. After the first data emerge from that study, the company will move into trials specifically for gastric and breast cancer.
8. Vor Biopharma
CEO: Robert Ang
Raise: $203.4 million
Snapshot: Vor priced at the high end of its range and raised an upsized $203.4 million, up from an estimated $150 million. That includes the options picked up by underwriters after the company priced. The goal for their IPO is to fund two of its programs, VOR33 and VCAR33, that it hopes can work hand in hand. VOR33 is a program of engineered hematopoietic stem cells designed to replace the standard of care in transplant settings, and once those cells have been engrafted, Vor says patients can be treated with anti-CD33 therapies like VCAR33. Vor currently has plans to start a Phase I/IIa trial for VOR33 in acute myeloid leukemia in the first half of this year, with funds from the raise also going toward preclinical development for myelodysplastic/myeloproliferative neoplasms. For VCAR33, a CD33-directed CAR-T cell therapy licensed from the NIH in November, Vor is seeking to fund a Phase I/II trial from launch through completion in adult AML. The biotech has significant backing, including a combined $152 million between two fundraising rounds with both co-led by RA Capital. Vor was founded by Columbia oncologist and Pulitzer Prize-winning author Siddhartha Mukherjee, who chronicled the promise and price of the first generation of CAR-T therapies for the New Yorker.
9. Terns Pharmaceuticals
CEO: Senthil Sundaram
Estimated raise: $128 million
Snapshot: Terns pulled in an $87.5 million Series C earlier in January but is now aiming to take advantage of the hot NASH market by going public, pricing at the high end of its range and raising an upsized $128 million. The company has seen a sharp rise since being founded with the help of Eli Lilly, which provided seed funding and licensed the company’s three NASH candidates, back in 2018. Terns has sent two of those programs to the clinic and is aiming to mainly fund a Phase IIa trial for lead candidate TERN-101 through completion. The program is expected to produce topline Phase IIa data in the second half of 2021 and is a liver-directed non-bile acid farnesoid X receptor (FXR) agonist being tested on 96 patients. While Terns faces competition from other NASH players like Intercept and AbbVie, which snagged an FXR agonist in the Allergan buyout, the company thinks its candidate’s safety profile is where it will stand out. Terns’ S-1 also detailed plans to complete a Phase I study and launch Phase II development for the program TERN-501, and to advance a third program TERN-201 through Phase Ib.
CEO: Berndt Modig
Estimated raise: $165 million
Snapshot: Pharvaris is heading to the Nasdaq after raising an $80 million Series C back in November, pricing above its range with an upsized $165 million raise. Their lead program, an inhibitor and selective small-molecule bradykinin B2-receptor antagonist, is in development as an oral alternative to currently available HAE treatments. Those include CSL’s Haegarda, Takeda’s Cinryze, Takhzyro and Firazyr, which are all injectable. Modig and his team of veterans come 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 that drug. Pharvaris is launching two Phase II trials, one for prophylaxis and one for treating acute HAE attacks. 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. They are also developing a new formulation that they plan to eventually use in prophylaxis trials. Pharvaris could face challenges, however, as other companies have struggled to develop oral HAE treatments in the past. Notably, BioCryst saw its shares cut in half last year after Phase III results fell short of investor expectations.
11. Evaxion Biotech
CEO: Lars Wegner
Raised: $30 million
Snapshot: A Danish company using artificial intelligence to develop immuno-oncology therapies, Evaxion priced at the low end of its range. The company has four programs it expects to fund using the IPO raise. Its lead program EVX-01, a personal immunotherapy treatment based on the individual patient’s DNA. Researchers say they are using an AI platform to get the body’s own immune system to find and kill the cancer tumor cells by applying an algorithm to select mutated proteins most likely to generate an immune response. Evaxion says it can deliver the therapy about 7 weeks after taking a patient’s blood sample. A Phase I/IIa readout in bladder cancer, malignant melanoma and NSCLC is expected in the first half of 2021. In addition to immuno-oncology, Evaxion is studying a vaccine program against bacterial diseases, called EVX-B1. IPO funding will help this candidate get through preclinical and CMC activities and to a hopeful regulatory filing in the second half of 2022.
12. Angion Biomedica
CEO: Jay Venkatesan
Raised: $80 million
Snapshot: Developing small molecule therapies for acute organ injuries, Angion priced at the high end of its range and raised a slightly upsized $80 million. Its lead program, ANG-3777, is currently enrolling Phase III studies for reducing the severity of delayed graft function after a kidney transplant. In an updated S-1, the company says it plans to commit $15 million to $25 million to fund this trial as well as prep an NDA for the compound. If everything goes as planned, data from the trial will read out by the end of 2021 with an NDA coming next year. ANG-3777 is also being studied in acute kidney injury associated with cardiac surgery, with a Phase II study underway. Some IPO funds will be directed toward launching a Phase III in this indication, as well as another Phase II study in ARDS related to Covid-19. Angion has a second clinical program called ANG-3070, which is in a Phase I trial for a fibrotic disease. Roughly $17 million to $27 million will push this Phase I through and launch a Phase II study for the program. Angion set its IPO terms on Feb. 1 and expects to price the same week.
CEO: Peter Luo
Raised: $140 million
Snapshot: Adagene discovered a new CAR-T candidate earlier in January, and sought to capitalize on the moment with an IPO. They succeeded, pulling in a raise slightly above expectations. Their program for renal cell carcinoma is the first of which the biotech is aware that targets a human endogenous retrovirus expressed in the majority of clear-cell kidney tumors. The CAR-T was developed in tandem with the NHLBI, and the NIH is expected to take over manufacturing and clinical development. Adagene’s IPO funds are slated to go elsewhere, with 95% of the raise penciled in for R&D. The exec team will direct 26% of funds toward its lead candidate, ADG106. A monoclonal antibody and CD137 agonist, the program 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. ADG116 has entered a Phase I study while ADG126 is still in preclinical stages. The last 43% allocated to R&D will help fund preclinical candidates and further platform development.
CEO: Stanislas Veillet
Raised: $20 million
Snapshot: Biophytis is taking a second crack at an IPO, having previously filed an F-1 back in May 2019. The company withdrew its $15 million pitch later that July due to “unfavorable market conditions,” but is penciling in the same amount for its latest attempt. If successful this time around, Biophytis plans on funneling most of the funds into its lead program: a small molecule dubbed Sarconeos, which the biotech believes can treat sarcopenia, Duchenne muscular dystrophy, and pneumonia related to SARS-CoV-2. The molecule is designed to activate the MAS receptor in muscle cells, a key component of the Renin-angiotensin system that controls things like fluid balance, blood pressure, cardiovascular function and muscular metabolism. Sarconeos’ initial target indication, sarcopenia, is the age-related degeneration of skeletal muscle. It’s currently in a Phase II study for sarcopenia with topline results coming in the second quarter this year, as well as a Phase II/III for Covid-19 patients with pneumonia. The first interim analysis for that indication is slated for 2021’s first quarter.
15. Decibel Therapeutics
CEO: Laurence Reid
Raised: $127 million
Snapshot: Decibel roughly doubled their capital in November after raising $82 million in a Series D, and now they’ve gone public just a couple of months later with an upsized $127 million raise. The company spent years focused on preventing hearing loss, but they pivoted last winter. Faced with what they characterized as surprising advancements in genomic and regenerative technology, and having failed to find a biomarker that could let them run a preventative trial, they decided to scrap key programs and focus on gene therapies that can restore hearing loss. Developed in partnership with Regeneron, Decibel’s gene therapy for the same protein isn’t scheduled to hit the clinic until 2022. Researchers are starting with fixing a single gene in people with the OTOF mutations, but the long-term goal is to build cures for more general hearing loss and balance disorders. The biotech is one of three Boston-area companies chasing cures for hearing disorders, next to the well-heeled gene therapy upstart Akouos and the stem cell regeneration developers at Frequency Therapeutics.
CEO: Scott Carmer
Raised: $110 million
Snapshot: Spun out of Johns Hopkins with a $23 million Series A back in 2018, NexImmune pulled in a higher than expected $110 million range. The company centers around the idea of specialized nanoparticles that act as antigen-presenting cells to incite a T cell attack on tumors, and had maintained a relatively low profile after that Series A, but researchers presented initial results from a Phase I/II study in its lead program at ASH last December. That study, for NEXI-001, is evaluating patients with acute myeloid leukemia. Among the first five patients dosed, 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, and aims to enroll between 22 and 28 patients. NexImmune’s other lead candidate NEXI-002 hasn’t yet had a data readout, but was dosed in the first patient with multiple myeloma last October. The company’s ultimate goal for its molecules 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. IPO funds will go toward both of these programs.
First published January 25, 2021.