Stoke Therapeutics Inc., fresh from its $90 million series B last October, has filed a prospectus for an IPO to raise up to $86.25 million. It is one of several companies in the past week that have filed for IPOs or are prepping for one.
This is a high-priced well-traveled path. Just in this year, biopharmas have raised $2.77 billion through 27 global IPOs, with $2.15 billion of it coming from 22 IPOs completed in the U.S.
"Compared with the top year of 2018, we are ahead by 20 percent, with 24 global IPOs in the first five months of 2018 raising $2.3 billion," BioWorld analyst Karen Pihl-Carey said. "Broken down to only U.S. IPOs, we fall right in line with last year when a total of 22 debuted on U.S. markets, raising a similar $2.1 billion. If things continue on this path, 2019 could beat out its record-breaking predecessor."
For the Stoke SEC filing, shares were neither priced nor numbered. The Bedford, Mass.-based company intends to put the money to work on a phase I/II trial in 2020 of STK-001, an antisense oligonucleotide (ASO) to treat Dravet syndrome (DS), a genetic epilepsy. The company has identified thousands of genes that could be addressed by its TANGO (Targeted Augmentation of Nuclear Gene Output) technology, which takes aim at non-productive RNA splicing to increase gene expression and address the root cause of monogenic diseases caused by loss or reduction of gene function.
DS is an autosomal dominant severe epileptic encephalopathy affecting more than 30,000 patients in the U.S., the EU and Japan. It's characterized by febrile seizures within the first year of life, then frequent, uncontrolled afebrile seizures and stagnation of mental development. Though the genetic mechanism is known – haploinsufficiency of SCN1A – there are no genetic therapies in development for DS, until now.
Stoke, which wants to trade on Nasdaq as STOK, intends to submit an IND for STK-001 by early 2020, initiate the clinical trial before the end of the second quarter and have data to contemplate in 2021. It also intends to nominate a second candidate to treat an additional genetic disease for preclinical development also in the first half of 2020. Targets include haploinsufficiency diseases of the CNS, eye, kidney and liver.
Two more Nasdaq debuts
Bicycle Therapeutics plc announced on Thursday the pricing of its IPO in the U.S of 4.3 million American depositary shares (ADSs) representing 4.3 million ordinary shares at an IPO price of $14 per ADS to raise $60.2 million. Bicycle granted the underwriters a 30-day option to purchase up to an additional 650,000 ADSs at the IPO price. The Cambridge, U.K. and Boston-based biopharma expects proceeds to be about $60.7 million.
The firm began trading on Nasdaq May 23 under the ticker symbol BCYC. The stock closed Friday at $13.05, up 8.75% for the day.
Like Bicycle, Ideaya Biosciences Inc. launched an IPO last week, as both companies chased money to put their cancer drugs in clinical trials. Ideaya generated $50 million by pricing 5 million shares at $10 each, slightly lower than its target of $13 to $15 per share. The company's lead candidate is IDE-196, a protein kinase C inhibitor for genetic cancers that have GNAQ or GNA11 mutations. Ideaya's stock (NASDAQ:IDYA) closed Friday at $11.25, up 6 cents for the day.
Biophytis SA, of Romainville, France, also leapt in by filing a registration statement with the SEC last week. All the securities to be sold will be offered by the company. The price range has yet to be determined. Biophytis' lead candidate is BIO-101 for treating neuromuscular diseases such as sarcopenia and Duchenne muscular dystrophy. Its follow-up candidate, BIO-201, is for treating retinal diseases that include dry age-related macular degeneration and Stargardt disease.
Of the eight biopharma companies sitting on the U.S. IPO pending list, two – New York-based Caelum Biosciences Inc. and Boston-based Karuna Therapeutics Inc. – filed via a confidential draft registration statement with the SEC in April 2018 and April 2019, respectively. One other, Dallas-based Peloton Therapeutics Inc. received a $2.2 billion buyout offer from Merck & Co. Inc. just last week. (See BioWorld, May 22, 2019.)
Other companies on the pending list include Boston-based Centrexion Therapeutics Corp., San Diego-based Cirius Therapeutics Inc., Cambridge, Mass.-based Codiak Biosciences Inc. Twelve other companies await their debuts on the Hong Kong Stock Exchange.
Last year's global IPOs raised $10.7 billion, nearly 54% more than 2000, the next highest year on record, which brought in $6.97 billion. In terms of the number of IPOs for the full year, there were 80 in 2018, which is second to the 84 completed in 2014.
"It is noteworthy, however, that the $2.14 billion raised in December was the second highest amount of IPO money ever collected by biopharma companies in a single month, behind November 2016's $3.8 billion, and for the month of December," BioWorld's Pihl-Carey said. "June and September of last year also hold records for their respective months, and 2019 now has the strongest February with $1.14 billion raised, possibly due to the government shutdown pushing back IPOs that would have occurred in January."