Three biopharmas founded in 2012 but with thoroughly disparate pipelines and missions filed for IPOs as the clock wound down on 2016. Braeburn Pharmaceuticals Inc., Jounce Therapeutics Inc. and Obseva SA filed registration statements with the SEC on Dec. 30, collectively seeking to raise $311.25 million and to list on Nasdaq.
Braeburn, of Princeton, N.J., is the only one of the three that has moved a product to market. Probuphine, a long-acting subdermal implant designed to deliver a six-month dosage of buprenorphine for long-term maintenance treatment of opioid addiction, was approved by the FDA in May 2016.
Braeburn is seeking to raise up to $150 million, including overallotments, and to list on Nasdaq under the ticker BBRX. Proceeds will fund a full-scale commercial launch of Probuphine with a field force of approximately 60 representatives during the first quarter. In its filing, the company said it has trained and certified approximately 2,400 health care providers to prescribe and implant Probuphine and that more than 70 payers have agreed to cover the drug.
Wholly owned by venture firm Apple Tree Partners, Braeburn in 2012 licensed exclusive commercialization rights to its lead drug in the U.S. and Canada from Titan Pharmaceuticals Inc., of South San Francisco, in return for a nonrefundable up-front payment of $15.75 million and milestone payments linked to FDA approval and sales and regulatory milestones for additional indications, including treatment of chronic pain. Titan also is eligible for tiered, double-digit percentage royalties on net sales. (See BioWorld Today, May 19, 2015.)
Despite support during two meetings of the FDA’s Psychopharmacologic Drugs Advisory Committee, the drug’s new drug application drew a complete response letter and, on a second try, an extended PDUFA date before finally gaining the FDA nod. (See BioWorld Today, March 22, 2013, May 2, 2013, Jan. 12, 2016, and Feb. 23, 2016.)
Braeburn also is advancing CAM2038, an injectable formulation of buprenorphine, for opioid addiction. In November, the company reported top-line data indicating that a phase III trial of weekly and monthly CAM2038 achieved noninferiority compared to oral daily buprenorphine based on the primary endpoint and superiority to oral daily buprenorphine based on a secondary endpoint.
In addition, the company is applying its implantable and injectable technology to reformulate other off-patent drugs and bring them to market using the 505(b)(2) pathway – in particular, in schizophrenia and spasticity.
J.P. Morgan, BofA Merrill Lynch and Deutsche Bank are the joint bookrunners on the deal, which was not priced. In its filing, Braeburn said up to 5 percent of shares in the offering were reserved for sale to directors, officers, employees, business associates and other insiders. Concurrent with the closing of the IPO, Braeburn also plans to execute a private placement of $40 million in common shares with Apple Tree.
In its filing, Braeburn cited cash and equivalents of approximately $23.5 million as of Sept. 30, 2016, and no outstanding common shares.
JOUNCE EXPLOITS I-O PROWESS
Jounce, of Cambridge, Mass., has made a splash in immuno-oncology (I-O), last year landing a $225 million up-front payment and a $36 million equity investment from Celgene Corp., of Summit, N.J., as part of a five-candidate I-O collaboration. The deal included Jounce’s lead candidate, JTX-2011 – a monoclonal antibody that binds to and activates inducible T-cell co-stimulators, or ICOS – and as many as four early stage immunotherapies targeting B cells, T regulatory cells and tumor-associated macrophages. (See BioWorld Today, July 20, 2016.)
In total, the Celgene alliance could garner Jounce up to $2.3 billion in regulatory, development and sales milestones if all programs reach commercialization, plus potential tiered royalties on ex-U.S. sales. The big biotech also gained an option to equally share a checkpoint I-O program.
Jounce, which is seeking to raise up to $75 million, including overallotments, also is conducting investigational new drug (IND)-enabling studies on JTX-4014, an anti-PD-1 antibody, for use in future combinations with JTX-2011 and with other future candidates. In its filing, the company said net proceeds from the IPO will be used to advance JTX-2011 through the completion of a multi-arm phase I/II trial, to complete the IND-enabling studies and planned clinical trials of JTX-4014 and to continue to build and expand its translational science platform and R&D pipeline. In 2013, founding investor Third Rock Ventures plowed $47 million into a series A financing for Jounce, which was followed in 2015 by a $56 million series B. (See BioWorld Today, Feb. 14, 2013, and April 23, 2015.)
Jounce plans to list on Nasdaq as JNCE. J.P. Morgan and Cowen & Co. are joint bookrunners on the offering, which was not priced. In its filing, the company reported $271.4 million in cash, equivalents and marketable securities as of Sept. 30, 2016, and approximately 91.5 million common shares as of Nov. 30, 2016.
OBSEVA LABORING IN WOMEN'S REPRODUCTIVE HEALTH
Obseva, of Geneva, was spun out of Merck Serono SA with a CHF32 million (US$34.7 million) series A financing led by Sofinnova Partners and co-led by Sofinnova Ventures and Novo A/S. The company added to its haul in 2015 with a $60 million series B round to advance its pipeline of drugs focused on women’s reproductive health and to provide enough firepower to expand its portfolio. Existing investors were joined in the second round by New Enterprise Associates, HBM Healthcare Investments, Orbimed and crossover investor Rock Springs Capital. (See BioWorld Today, Aug. 29, 2013, and Nov. 24, 2015.)
Obseva was founded by former executives of Preglem SA, a Swiss-based specialty biopharma, to focus on therapies to treat women’s reproductive health and pregnancy-related disorders. Its portfolio consists of three in-licensed assets, starting with OBE2109 to treat pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids. The company has a multiple-dose, placebo-controlled phase IIb trial of the oral gonadotropin-releasing hormone, or GnRH, receptor antagonist underway in patients with endometriosis across 46 sites in the U.S. and 15 sites in Central and Eastern Europe, with a target enrollment of 330 patients.
The company also is developing OBE001 (nolasiban), an oral oxytocin receptor antagonist, to improve outcomes associated with in vitro fertilization, and OBE022, an oral and selective prostaglandin F2-alpha, or PGF2-alpha, receptor antagonist, as a once-daily treatment for preterm labor.
Obseva is seeking to raise up to $86 million in the IPO and plans to grant underwriters a 30-day option to purchase an undisclosed number of additional shares to fill overallotments. In its F-1, the company said it applied to list its common shares on Nasdaq under the symbol OBSV.
Credit Suisse, Jefferies and Leerink Partners are the joint bookrunners on the offering, which was not priced.
Obseva cited cash and equivalents of $38.9 million as of Sept. 30, 2016.