While biotech’s fortunes hit the skid on Wall Street last week, the sector’s biggest IPO of the year went off without a hitch Thursday, suggesting investors haven’t lost their appetite for high-risk, high-reward science. And biotech’s red-hot IPO streak shows no signs of abetting. Here’s the landslide of frenetic activity that took place in just the span of a mere five days.
1) On Thursday (October 11, 2018), cancer drugmaker Allogene Therapeutics Inc. (South San Francisco) pulled off the biggest public offering in at least a decade (and one of the most lucrative, according to Fortune). The firm raised $324 million in an offering that pegs the company’s market value at a jaw-dropping $2 billion-plus. The deal priced at $18 per share, the top of the estimated range. The last time a firm even came close to that was Alzheimer’s drug developer Axovant Inc.’s (Hamilton BMU) $315 million raise in 2015. It should be noted that Axovant Ltd.’s lead pre-clinical drug at the time went on to flop in spectacular ignominy a little more than a year ago.
Allogene is developing a different approach to a new form of cancer therapy called CAR-T. This kind of treatment involves re-engineering patients’ own immune cells in order to become targeted cancer killers; the modified cells are then grown in a lab, multiplied, and then re-inserted into patients, and has shown promise for some patients with deadly blood cancers. The first therapies of this kind from Novartis AG and Gilead Sciences Inc. subsidiary Kite Pharma, respectively, were approved last year by the Food and Drug Administration.
Allogene’s methodology aims to create an “off-the-shelf” version of CAR-T therapy. That is, their treatment, theoretically, could be created from any immune cell donors’ cells rather than having to extract each batch individually from a patient. This would ostensibly cut down on manufacturing and production costs while reducing invasive procedures on cancer patients.
The management team at Allogene, which is led by Arie Belldegrun and David Chang, is likely a large part of the reason for the mammoth IPO. The pair were previously at Kite Pharma, which was sold to Gilead for $12 billion right ahead of its landmark CAR-T treatment approval for Yescarta. The biotech’s off-the-shelf technology was folded in from drug giant Pfizer Inc.
2) Elsewhere, Hoth Therapeutics Inc., a biotech developing therapies for eczema, announced terms for its initial public offering on Thursday as well. The NYC-based company plans to raise $11 million by offering 1.8 million shares at a price range of $5.50 to $6.50. At the midpoint of the proposed range, Hoth Therapeutics would command a fully diluted market value of $91 million. Hoth in-licensed rights to a technology that combines an “FDA-approved zinc chelator with one or more approved antibiotics in a topical dosage form to address unchecked eczema flare-ups by preventing the formation of infectious biofilms and the resulting clogging of sweat ducts which trigger symptoms.”
Hoth founded in 2017 and plans to list on the Nasdaq under the symbol “HOTH.” The Benchmark Company is the sole bookrunner on the deal.
3) LogicBio Therapeutics Inc., a preclinical gene-editing biotech developing therapies for rare diseases, announced terms for its IPO. The Cambridge, MA-based company plans to raise $75 million by offering 5.8 million shares at a price range of $12 to $14. At the midpoint of the proposed range, LogicBio would command a fully diluted market value of $294 million. Net IPO proceeds will be used to advance its lead asset, a treatment for the genetic liver disease methylmalonic acidemia (MMA), into the clinic. The IPO haul would fund a Phase 1/2 trial for the LB-001, LogicBio’s gene-editing treatment for MMA, “through the initial data read-out, clinical development outsourcing, drug manufacturing and internal personnel costs,” the company said in its S-1, filed in September.
LogicBio Therapeutics was founded in 2014 and plans to list on the Nasdaq under the symbol “LOGC.” Jefferies, Barclays and William Blair are the joint bookrunners on the deal. It is expected to price this week.
4) Included among recent SEC filings for initial public offerings, Axonics Modulation Technologies Inc., which is commercializing a neural implant for overactive bladder and incontinence, registered up to $86 million worth of common stock. The med tech company has developed an implantable rechargeable neuromodulation device that stimulates the sacral nerve as a way to treat overactive bladder, fecal incontinence and urinary retention. The system, called the r-SNM, delivers mild electrical pulses via a four-electrode lead inserted through the sacrum (triangular bone in the lower back between the two hip bones) during a brief surgical procedure. The device is currently approved for sale in Europe, Canada and Australia. A US marketing application is on tap for Q1 2019.
Irvine, CA-based Axonics was founded in 2012. It plans to list on the Nasdaq under the symbol “AXNX.” BofA Merrill Lynch and Morgan Stanley are the joint bookrunners on the deal. No pricing terms were disclosed.
5) PhaseBio Pharmaceuticals Inc., an early-stage biotech developing therapies to treat orphan diseases, announced terms for its IPO on Friday. The Malvern, PA-based company plans to raise $65 million by offering 5 million shares at a price range of $12 to $14. At the midpoint of the proposed range, PhaseBio would command a fully diluted market value of $269 million. The company is developing a novel reversal agent for ticagrelor called PB2452, for the treatment of patients on the antiplatelet drug who are experiencing a major bleeding event or those who require urgent surgery. The company recently completed a Phase 1 dose ranging clinical trial of PB2452 in healthy subjects, achieving rapid and complete reversal of ticagrelor’s antiplatelet activity within five minutes following initiation of infusion.
PhaseBio was founded in 2002 and plans to list on the Nasdaq under the symbol “PHAS.” Citi, Cowen and Stifel are the joint bookrunners on the deal.
6) London-based commercial-stage biopharmaceutical firm Orchard Rx Ltd. (soon to be Orchard Therapeutics) registered up to $172.5 million worth of American Depositary Squares. Orchard Rx is developing a gene-therapy treatment called Strimvelis targeting “bubble boy” disease and other rare genetic conditions. Orchard, whose shareholders include drug giant GlaxoSmithKline PLC, filed its IPO plans Thursday, less than two months after raising $148 million in an oversubscribed Series C round. Orchard plans to use some of its IPO cash to design, renovate and operate a 152,995-square-foot facility in Fremont, CA, where it plans to make drug candidates and so-called “viral vectors”–shells of a virus that are re-engineered to remove a virus’s genes that then are used as vessels to carry corrective genes to a host cell in the body. Strimvelis was approved by the European Union in 2016 for a subset of “bubble boy” disease patients.
Orchard plans to seek FDA approval of Strimvelis in 2020. The agency already has designated the drug as “breakthrough therapy.” Founded in 2015, the company expects to apply to list the ADSs on Nasdaq Global Market under the symbol “ORTX.” Lead underwriters for the offering are J.P. Morgan. Goldman Sachs and Cowen & Co.
7) Guardant Health Inc. shares jumped almost 70% in their first day of trading on Thursday. The Redwood City, CA-based oncology company, backed by SoftBank, sold 12.5 million shares at $19 in its IPO. CEO Helmy Eltoukhy told CNBC on Thursday the company’s liquid biopsy, Guardant360, is a “big game changer” when it comes to the detection of cancer.
“Traditionally, late-stage patients would need a tissue biopsy–physically accessing and cutting a piece of their tumor tissue–for the physician to be able to match them with the most effective therapies. We can do that with a simple blood test in about half or a third of the time,” he said on “Power Lunch.”
Guardant Health matches the results with data to help unlock “tiny signals” in blood and to coordinate those signals with the best possible therapy, he explained. While the technology is currently being used in late-stage diseases, Guardant Health is looking to make it more sensitive so it can eventually be used for early detection. Shares closed the week up a whopping 77% to $33.54.
8) Change Healthcare Inc. has reportedly hired a team of underwriters to lead an initial public offering, potentially signaling the end of the two-year IPO drought in the digital health space. Citing sources familiar with the matter, Reuters identified the IPO underwriters as Goldman Sachs Group, Barclays and J.P. Morgan Chase. The IPO could be valued as high as $12 billion, according to the report. A recent regulatory filing by McKesson Corp., which has a majority stake in Change, shows $856 million in revenue for the revenue cycle management and analytics outfit during the three months ended June 30.
While details are scarce, sources told Reuters a Change IPO is expected in the first half of next year. That timeline would mesh with what McKesson CEO John Hammergren told investors at J.P. Morgan’s healthcare conference in January.
9) And Twist Bioscience Inc. filed a preliminary prospectus for an $86 million IPO. The synthetic biology company has developed a DNA synthesis platform that it says enables the industrialization of biology engineering. The core of the platform provides a method of making synthetic DNA by “writing” it on a silicon chip. It plans to develop products like synthetic genes, tools for next-gen sample preparation and antibody libraries for drug discovery and development. Despite an ongoing lawsuit over alleged theft of intellectual property, San Francisco-based Twist filed with the SEC saying it focuses on DNA synthesis, manufacturing synthetic DNA. The company noted that it is developing synthetic genes, which will be used as tools for next-generation sample preparation, and antibody libraries for drug discovery and development. The company plans to list on the Nasdaq Exchange under the ticker symbol “TWST.”
In its SEC filing, Twist Bioscience noted that it is facing the lawsuit filed by Agilent. The lawsuit, which was filed two years ago, alleges that Twist’s CEO Emily Leproust, who is a former Agilent employee, stole trade secrets that helped her launch Twist. According to Agilent’s lawsuit, Leproust, who left the company in 2013, began pitching the idea of launching Twist to venture capitalists before her resignation. Twist has vowed to fight the allegations.