It was a busy week for biopharma, biotech and medical device initial public offerings (IPOs). Here’s a look.
New York-based Intra-Cellular Therapies announced the pricing of its underwritten IPO of 4,750,000 shares at $24 per share, in hopes of raising about $106.5 million. On September 9, the company announced positive topline results from its Phase III Study 402 clinical trial of lumateperone as adjunctive therapy to lithium or valproate to treat major depressive episodes associated with Bipolar I or Bipolar II disorder. The study found that once-daily lumateperone 42 mg hit the primary endpoint for improvement in depression. It was measured by change from baseline compared to placebo on the MADRS total score. It also met the key secondary endpoint of CGI-BP-S Depression Score.
Lumateperone is an antagonist with high binding affinity at serotonin 5-HT2A receptors, also an antagonist with moderate binding affinity at postsynaptic D2 receptors, and an inhibitor of the reuptake of serotonin transporter (SERT) with moderate binding affinity. It is also a partial agonist with moderate affinity at D1 receptors.
Pleasanton, California-based 10X Genomics set its IPO price at $110 per share. It is offering 3 million shares of its Class A common stock and up to an additional 600,000 shares of its Class A common stock that the underwriters have the right to purchase at the public offering price.
On August 11, the company announced its second-quarter financial results. Revenue for the quarter was down 23% to $42.9 million, largely the results of widespread customer laboratory closures during the COVID-19 pandemic. The company’s products include the Chromium and Visium platforms, which are targeted gene expression assays. Recently, the company launched the Visium Clinical Translational Research Network to improve and speed workflows associated to assessing the spatial cellular relationship in clinical translational research studies. It announced the first 45 members, which included GlaxoSmithKline, Johns Hopkins Medical Institutes and Mass General Cancer Center.
Headquartered in Cambridge, Massachusetts, Spero Therapeutics announced an IPO price of $10 for an underwritten public offering of 4,785,000 common shares and 3,215,000 shares of its non-voting Series D Convertible Preferred Stock. They expect the total to be $80 million. Spero focuses on treatments for multi-drug resistant bacterial infections.
On September 8, Spero announced positive topline data from ADAPT-PO, its pivotal Phase III clinical trial of tebipenem HBr, an oral antibiotic for adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP). The data showed the antibiotic was statistically non-inferior to intravenous ertapenem for these patient populations.
“The results of ADAPT-PO are truly exciting and welcome news for the medical community and for the millions of U.S. patients suffering from cUTI and AP annually,” said Keith Kaye, director of research in the Division of Infectious Diseases at the University of Michigan Medical School. “Due to the increasing prevalence of antibiotic-resistant bacteria, many patients with cUTI now receive intravenous antibiotics as their only available treatment option. The much-anticipated data from this head-to-head comparison against an IV standard-of-care carbapenem antibiotic suggest that in many instances oral, outpatient treatment of these complicated bacterial infections is a viable option.”
Coming up on the calendar are IPOs for Metacrine, Outset Medical, American Well Corp. and Dyne Therapeutics.
Metacrine is focused on treatments for liver and gastrointestinal (GI) diseases. Its most advanced program targets the farnesoid X receptor (FXR), which is being evaluated in non-alcoholic steatohepatitis (NASH). It presented Phase Ib data in August at the Digital International liver Congress, which were positive.
Outset Medical set its IPO price at $22 to $24 for 7.6 million shares in hopes of raising up to $182.4 million. It will be listed on the Nasdaq under the “OM” ticker. In July, the company reported the first person in the world was treated using its mobile Tablo Hemodialysis System at home. It received FDA clearance on March 31.
American Well Corp (Amwell), a telehealth company, announced its proposed IPO, with plans to offer 35 million shares of its Class A common stock to the company for $14 to $16 per share. It plans to list its common stock on the NYSE under the “AMWL” ticker symbol.
Dyne Therapeutics plans to offer 10.3 million shares in its IPO at $16 to $18 per share. The proceeds will be leveraged to finance research and development, develop its proprietary FORCE platform and for general corporate purposes. It will trade on the Nasdaq under “DYN.”
On August 10, the company closed on a $115 million equity financing led by Vida Ventures and Surveyor Capital, along with Wellington Management Company, Logos Capital, Franklin Templeton and an undisclosed institutional investor. They were joined by existing investors Atlas Venture, Forbion and MPM Capital.
The company’s pipeline focuses on muscle disease therapies. Its lead programs are in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and fascioscapulohumeral muscular dystrophy (FSHD).