A look at every biotech IPO filed and the amount raised across the world's major indexes. Compiled by associate editor Max Gelman.
The British biotech is most famous for creating the technology behind the AstraZeneca/Oxford University Covid-19 vaccine, with its co-founder Sarah Gilbert having headed up that research. Vaccitech’s push to go public came just a couple of weeks after raising an impressive $168 million for a Series B round, led by London investment firm M&G and joined by Gilead and Tencent, among others. Concerns have arisen over the AstraZeneca shot due to a rare side effect of blood clots in younger recipients, however, which may limit some of the optimism surrounding the biotech. The EMA and MHRA have both requested that clots be listed as a very rare potential risk to the vaccine, though they noted the benefits of getting the shot continue to outweigh those risks. Vaccitech noted these concerns in its S-1 “risk factor” section, writing that in addition to the positive risk-benefit profile of the vaccine, “there can be no assurance that the vaccine is not associated with an increase in the overall risk of thromboembolic events.” AstraZeneca also paused its vaccine trial in children as the clotting worries continued.
Despite its UK deal to supply Covid-19 vaccines, Valneva is wary of export tensions between Britain and the EU slowing down delivery times. The biotech highlighted the potential risk that’s been in the news recently, noting in its S-1 that export restrictions may affect its ability to deliver those shots promised to the UK. Valneva has commitments to deliver 100 million vaccines to Britain by 2022, with the UK owning additional options for another 90 million in supply between 2023 and 2025. They haven’t opted-in just yet, but thanks to Brexit, Valneva said any limits on imports or exports may pose a “substantial” risk as the shots are manufactured in the UK but packaged in the EU. The company itself is headquartered across the English channel in Saint-Herblain, France. The April 9 filing comes just a few days after the biotech reported new positive vaccine data from a Phase I/II trial, and a Phase III could begin as soon as the end of the month. Valneva tested three dosing levels, and like many other Covid-19 shots being tested or authorized, it was administered in two jabs three weeks apart. It’s also working on a Lyme disease vaccine with Pfizer, having launched a Phase II study for that candidate in March.
Boston-based Werewolf outlined some of its plans to hit the clinic back in January, when CEO Dan Hicklin took the wraps off a $72 million Series B. Using an engineering platform dubbed PREDATOR, the company has three molecules belonging to a class they dub Indukines, which comprises four components: a cytokine, an inactivation domain, a half-life extension domain and a linker that can be cleaved by proteases found in tumors. That way, they reason, the drug stays quiet throughout the body and only triggers an inflammatory effect against cancer. The system makes use of technologies from Harpoon — a fellow MPM company — including “polypeptides and a binding moiety for conditional activation of certain polypeptides.” In addition to promising royalties and exchanging certain other patent rights, Werewolf paid a grand $500,000 upfront to Harpoon, which is building an operation around T cell engagement. With an initial focus on IL-2 and IL-12, Werewolf is looking to begin human testing for WTX-124 and WTX-330 in 2022. The third candidate aims to conditionally activate IFN-a.
Until earlier this year, Artiva didn’t have much of a profile in biopharma land. Former Bellicum CEO Tom Farrell had assembled an NK cell therapy company, leaning heavily on a “hugely impressive” manufacturing facility belonging to Green Cross LabCell in Korea, gathered $78 million in Series A money and did the news rounds last June, then stayed largely quiet. That changed when Merck signed a collaboration worth nearly $2 billion in milestones to pick up the off-the-shelf NK cell tech. Artiva quickly followed up with a $120 million Series B, designed to kickstart Phase I/II for its lead program in non-Hodgkin’s lymphoma. The partnership deal, Artiva revealed in its S-1, gave GC LabCell a 28% stake in the biotech, almost double the holdings of 5AM Ventures, venBio, RA Capital and more than quadruple what Venrock has.
More than two years after its crossover raise, Impel NeuroPharma is finally heading to Nasdaq. The Seattle-based biotech has a unique approach for getting CNS drugs delivered to the brain — through the nose. Impel’s tech is centered around a delivery system of nasal doses of old and thoroughly understood drugs, with research going toward migraines, Parkinson’s and agitation related to autism. Led by CEO Adrian Adams, Impel hopes an enhanced nasal delivery approach can improve a drug’s performance, offering an opening for an improved therapeutic effect with a liquid or dry formulation of an old drug. Their migraine program has completed its pivotal study, with an expected PDUFA date of Sept. 6 later this year. As such, the majority of the planned IPO cash will go toward funding the potential commercial launch of the migraine treatment, which Impel plans to market as Trudhesa. The drug is an upper nasal formulation of dihydroergotamine to treat acute migraines. The remainder of the IPO funds will help the INP105 program, designed for acute treatment of agitation and aggression associated with autism spectrum disorder. This candidate is a nasal reformulation of olanzapine.
Rain Therapeutics saw a shower of good fortune in 2020. Around Labor Day last year, the biotech tripled its pipeline in the span of a week, licensing a research program from Drexel University and nabbing a Phase II-ready drug from Daiichi Sankyo. Rain followed that up with a $63 million fundraise shortly after to push forward all three of its programs. The Daiichi program has now become Rain’s lead. Dubbed RAIN-32, the candidate will see the bulk of Rain’s IPO funds funneled toward it. Per the S-1, Rain plans to launch three studies for RAIN-32, including a pivotal Phase III study in an MDM2-amplified subtype of liposarcoma. The newer candidates pair up with the company’s original mission, one which helped it launch with an $18 million Series A back in 2018. Rain’s first experimental drug was tarloxotinib, a small molecule inhibitor designed to target low oxygen levels in tumors, thereby sparing healthy tissues.
Anebulo Pharmaceuticals penciled in a modest $15 million for its IPO raise. The Lakeway, TX-based company, founded just last year, is focused on developing treatment for cannabinoid overdose and substance addiction. Anebulo’s lead candidate, ANEB-001, is designed to reverse the negative effects of cannabinoid overdose within one hour of administration. Anebulo is hoping to fully finance a Phase II proof-of-concept study for the program with its IPO money. But this won’t be the last time Anebulo is looking to raise money — in their S-1, they noted that they’ll have more capital in about 18 months to run the pivotal safety trials, launch the drug commercially and make milestone payments to Vernalis, from whom Anebulo licensed its program.
Zymergen’s IPO pitch comes five years after the synthetic biology company raised $174 million from investors by piquing interest in designer microbes. The company so far has specialized in engineering microbes for new materials, including electronics and insect repellent, or for manufacturing chemicals and fuels. But they’ve also quietly been involved in drug development and manufacturing biologics. Their IPO haul, which could be significant, represents a major milestone for a synthetic biology field that has been trying to remake corners of the biopharma industry. The amount they ultimately raise could provide a benchmark for the next widely anticipated synthetic biology IPO: Ginkgo Bioworks, which has played a much more direct role in drug development, teaming with Roche, Moderna and Synlogic. Zymergen has yet to make any major public inroads into biopharma, but they say on their website in a section labeled “emerging areas” that they are actively using their genetic libraries, high-throughput systems and other technologies to develop drugs for oncology and infectious diseases. Their first product, a film that allows customers to make foldable touchscreens, was launched in December 2020. Zymergen set its terms on April 14.
Founded and led by CRO vet Michael Dudley, Boston-based TransCode Therapeutics is focused on delivering RNA drugs to where they are needed to kill cancer, and they are ambitious. All of their programs are still in the preclinical stage, with the lead candidate designed to treat metastatic cancer — meaning tumors in the breast, pancreas, ovary, colon or even the brain. According to the company’s S-1, TransCode’s strategy seeks to overcome delivery challenges by repurposing a particle, which are used extensively in humans for imaging purposes, to deliver synthetic RNA molecules to cancer cells. TransCode is also developing a PD-L1 that they’re hoping to use for pancreatic cancer, melanoma, NSCLC and breast cancer. For their next step, the company intends to advance the lead program to the clinic for those suffering from late-stage cancer. In March 2020, TransCode received FDA guidance for their first proposed study as part of its pre-IND submission.
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.
Recursion’s $239 million Series D marked one of the largest, if not the single largest, funding rounds for an artificial-intelligence-focused biotech. That approach centers around a 100,000 square-foot warehouse in downtown Salt Lake City, where robots take Petri dishes of different cell types and knock out different genes. They’re constantly taking pictures in the process, with the differences being too small for a human eye to differentiate. But their computers can, and by doing so pick up patterns to indicate what can make a cell sick and which genes, when targeted, can make them healthy. Within its S-1, Recursion signaled a broad development push across its pipeline. The biotech plans to focus the funds on Phase II trials for four of its programs: REC-4881 for familial adenomatous polyposis, REC-3599 for GM2 gangliosidosis, REC-2282 for neurofibromatosis type 2 and REC-994 for cerebral cavernous malformation. There are also plans to use some of the money on six of the biotech’s preclinical candidates, including Batten disease, solid and hematological malignancies and the lead molecule for the treatment of C. difficile colitis.
Backed by Novo Ventures and Abingworth, Reneo had enough cash beforehand to take them through the completion of three early- to mid-stage trials for their lead program, REN001, CEO Gregory Flesher told Endpoints at the time. Within its S-1, Reneo has now detailed its plans to use the IPO funds to complete those studies in primary mitochondrial myopathies, fatty acid oxidation disorders and McArdle disease. REN001 is a PPAR-delta agonist, and the three conditions Reneo is looking at are related to different parts of mitochondrial function. A once-daily pill, REN001 has the ability to help cells express certain genes within the mitochondria that increase a patient’s metabolism. Though it’s not a gene therapy, the ultimate goal is to help patients replenish mitochondria cells once old ones die off while simultaneously boosting enzyme production.
Luca Santarelli tells a straightforward story about VectivBio. After selling Therachon to Pfizer in an $810 million deal, the Roche vet immediately spun out with the new company, taking their Phase II drug apraglutide for short bowel syndrome. The IPO was a natural next step on the heels of a mega-raise of $110 million announced last October, with the focus still squarely on executing the Phase III and laying the foundation for commercialization work. A long-acting synthetic peptide analog of GLP-2, apraglutide remains the sole asset in the company and will be deployed in a range of rare gastrointestinal disorders outside of SBS. Topline results for the lead indication, in SBS intestinal failure, are expected in 2023. While VectivBio is looking to in-license or acquire additional drugs for the pipeline, the IPO proceeds are mostly going toward the core program — including a Phase II targeting a subgroup of SBS-IF patients with colon-in-continuity anatomy and proof of concept in apraglutide’s utility for gastrointestinal manifestations of graft-versus-host disease.
Achilles pulled in a $175.5 million raise to take its T cell therapies targeting clonal neoantigens to Nasdaq. Co-founded by Charlie Swanton of the Francis Crick Institute, the UK biotech aims to leverage heavy sequencing to identify a patient-specific set of tumor mutations that it can target. Unlike other neoantigen pioneers like Gritstone Oncology, Neon Therapeutics and BioNTech, Achilles is looking to directly deliver cancer killing T cells rather than stimulating an immune response via a vaccine. Achilles got a boost in September 2019 with a $121 million Series B thanks to a syndicate led by RA Capital. And in November 2020, the biotech pulled in another $69.7 million for an oversubscribed Series C.
Based out of Boston, Ikena got started with a $49 million Series A back in 2017, pulling in funds from high-profile backers like OrbiMed and Atlas Ventures to advance its immunometabolism therapies to treat cancer. The idea is to leverage metabolic pathways and the broken-down molecules that result from the body’s metabolism into suppressing the body’s immune system. Ikena’s lead in-house program is IK-930, an oral small molecule inhibitor of a transcription factor known as TEAD, or the transcriptional enhanced associate domain. It deals with Hippo pathway mutations, with Ikena hoping the candidate can help regulate polarity, proliferation and tissue homeostasis, among other things, in solid tumors. They’re hoping to submit an IND here in the second half of 2021. There’s also two BMS-partnered programs dealing with TDO and IDO, although indirectly. BMS owns a roughly 8% stake in the company after Celgene teamed up with then-Kyn Therapeutics in early 2019.
Edgewise is focusing on rare muscle disorders, with ambitions in Duchenne muscular dystrophy, Becker muscular dystrophy, and limb-girdle muscular dystrophy. Its lead program is already in the clinic. Edgewise says that EDG-5506 is a small molecule inhibitor for fast myofiber (type II) myosin designed to address the root cause of dystrophinopathies. It’s currently in a Phase I trial for DMD, Becker and LGMD and Edgewise hopes it can limit the hypercontraction stress caused by the lack of dystrophin in these diseases. About $80 million of the IPO funds will be funneled toward this program to get it through the Phase I study and through the interim readout of a Phase II/III study. An additional $55 million is earmarked for the research and development of three preclinical programs, EDG-6289, EDG-002 and EDG-003. EDG-6289 is listed as a muscle stabilizer, while the other two are billed as muscle desensitizers.
Design secured its launch round just over a year ago, and is now taking its GeneTAC platform public. The San Diego-based biotech focuses on degenerative diseases linked to nucleotide repeat expansions, and is co-founded and chaired by Pratik Shah, who previously helped engineer two multi-billion M&A deals. Shah was CEO of Auspex for 2 years before Teva scooped it up for $3.5 billion in 2015, and he was also chairman at Synthorx, which Sanofi bought out for $2.5 billion at the end of 2019. GeneTAC, short for gene targeted chimeras, helps Design go after what it says are more than 40 degenerative diseases caused by nucleotide repeat expansions. The biotech has two pipeline programs thus far, one in Friedreich’s ataxia and one in myotonic dystrophy type-1. IPO funds are slated to go toward both of these programs, Design wrote in its S-1. It estimates $30 million is needed to take the Friedreich’s ataxia candidate through a Phase I trial and $35 million to take the DM1 program through Phase I. Another $35 million will fund a currently undisclosed program, with the remainder of the cash going toward general R&D and corporate purposes.
The Ji’an, Jiangxi, China-based company markets its programs toward the elderly in China with its traditional Chinese medicine derivatives, with the goal of addressing physical conditions related to aging as well as their general well-being. Founded in 2019, Universe boasts 26 registrations and approvals with Chinese regulators and sells 13 products as of early March. Within its F-1, Universe says it’s splitting the IPO raise into four roughly equal parts. There is 28% listed for upgrading and expanding manufacturing facilities, 27% for R&D, 24% for marketing and 21% for corporate upkeep.
Lava debuted back in May 2018 with a modest $18.9 million to research what was then a nascent field: gamma delta T cells. They stayed almost entirely under the radar — not issuing another press release for over a year and a half — until announcing a cancer bispecifics partnership with J&J’s Janssen in May 2020. A few months later, they returned to the venture well with $83 million in Series C financing and two programs ready for the clinic. With a focus on immuno-oncology, the Dutch-American biotech’s scientific approach involves building bispecific antibodies that grab a receptor on gamma delta T cells and link it with a particular protein on the tumor, aiming to only activate while in the vicinity of the cancer. Lava also says its therapies can help induce immune memory of the cancer, should it appear again, due to gamma delta T cells’ similarity to antigen-presenting cells. The biotech built its research on the scientific discoveries of CSO Hans van der Vliet, an oncologist at VU University Medical Center and Cancer Center Amsterdam.
By diving into tumor-infiltrating lymphocytes, Instil Bio faces some high-profile competition not just with TIL players like Iovance, Adaptimmune and PACT Pharma but also CAR-T and TCR-T cell therapy developers like Gilead’s Kite and Bristol Myers Squibb’s Juno. Yet the Dallas-based biotech is all-in on the tech platform, including the manufacturing know-how, it first in-licensed then acquired from Immetacyte, a University of Manchester spinout that’s been running a compassionate use program at a UK hospital for eight years. Since its founding in 2018, it’s raised $380 million of venture funding to get here, and CEO Bronson Crouch’s crew initially penciled in another $100 million raise, but that figure was upsized to $250 million when Instil set its IPO terms on March 15. Instil ultimately priced at $20 per share with a $320 million raise. The plan now is to submit an IND to the FDA — its first — and jump straight into a Phase II trial for melanoma later this year, which Instil hopes can support a BLA submission as early as 2023. Given how frequently CMC issues trip up cell and gene therapies these days, though, there’s likely a long way to go for its in-house manufacturing crew.
Founded by two old pals whose friendship traces back to a university in Guangzhou, China, Connect Biopharma had snagged $115 million from a slate of marquee investors back in August. Now, they’re ready to take the company to Nasdaq with a pipeline of immune modulators, led by an anti-IL-4Ra antibody that can treat inflammatory allergic diseases such as atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps. These are big indications chased by some of the top names in the global biopharma world — the lead drug hits the same target as Regeneron and Sanofi’s Dupixent — but Connect believes the assays they used in drug discovery could make them a best-in-class contender. The big reveal will come in the second half of 2021, when topline Phase IIb results are due. For now, the Phase Ib results will have to do, results that showed a four-week treatment improved skin lesion and pruritus in moderate-to-severe atopic dermatitis patients. Connect set its terms on March 12.
Having sought a relatively modest raise given the run of biotechs over the last year or so to go after hefty IPO cash, Gain raised $40 million for its public offering. 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. Gain set its terms on March 10.
When Mark Smith helped start the nonprofit stool bank OpenBiome in 2012, there weren’t reliable, standardized ways to manufacture and distribute stool preparations for fecal microbiota transplants. More than eight years later, he believes new alternatives are on the horizon. Finch Therapeutics’ S-1 dropped just days after OpenBiome announced it’s phasing out production of new treatments, with an aim to save enough inventory to meet demand throughout 2021 “as a bridge to FDA-approved therapies.” The biotech wants to bring one of those therapies to the market. CP101, a capsule made of freeze-dried stool samples from healthy donors, has hit the mark on recurrence-free bacteria clearance for patients with a C. difficile infection — results that Smith, co-founder and CEO at Finch, said came at a turning point for the field. After some early failures and implosions, scientists may have found the right way to pack all the benefits of a fecal microbiota transplant (FMT) into a pill and skip the cumbersome procedure. Smith raised $128 million in the IPO to accomplish this, and a second, confirmatory trial is expected to begin not long after Finch lands on Nasdaq and should read out in 2023. Finch set its terms on March 15.
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. Longboard set terms for its IPO on March 8.
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. Prometheus set its IPO terms on March 8.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Pharvaris is heading to 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.
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.
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.
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.
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.
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.
