Closing of the transaction is anticipated to occur after the consummation of the proposed merger of RDD and Innovate Biopharmaceuticals, Inc. (Nasdaq: INNT) which will form a combined company (the “INNT Merger”) intended to be named 9 Meters Biopharma, Inc. In exchange, Naia will receive a combination of cash and shares in 9 Meters Biopharma subject to closing of the INNT Merger. Pursuant to the terms of the LOI, the combined company would acquire all of the outstanding capital stock of privately-held Naia.
“Combining the pipelines of RDD, Innovate and Naia Rare Diseases into 9 Meters Biopharma would create a next generation gastroenterology company focused on developing treatments for unmet needs in specialty, rare and orphan indications. From Naia’s drug candidates to the first-ever Phase 3 registration trial in celiac disease, we expect multiple value creating inflection points over the next 24 months,” said John Temperato, the current CEO of RDD and named CEO of 9 Meters Biopharma. 9 Meters will be poised to realize these inflection points behind a highly seasoned management team especially adept at in-licensing, developing and commercializing multi-billion dollar assets in gastroenterology, along with prominent healthcare-dedicated institutional investors, led by Orbimed Advisors, LLC.
Through the transaction, the combined company will acquire Naia’s investigational therapeutic, NB-1001, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist that combines exenatide with a proprietary extended half-life technology for the treatment of SBS. Long-acting NB-1001 extends the half-life of GLP-1 and allows for up to once-per-month dosing, considerably increasing administration convenience with a potentially improved safety profile versus other GLP-1 agonists secondary to lower overall exposure and dose required. The proposed agreement includes a glucagon-like peptide 2 (GLP-2) analogue with improved serum half-life compared with short-acting versions, which the company intends to progress through a clinical and regulatory pathway in an undisclosed orphan and rare gastrointestinal indication.
NB-1001 has demonstrated efficacy and an extended half-life up to 30 days in a 70-patient clinical study1 and received orphan drug designation by the U.S. Food and Drug Administration. The companies, along with Cedars-Sinai Medical Center, plan to initiate a clinical program in SBS in 2020, with the goal of developing a safer, more efficacious and convenient therapy.
“People living with Short Bowel Syndrome have unique, unmet motility needs and NB-1001 is one of the only compounds in development to directly address this by potentially allowing for elimination of parenteral nutrition and an improvement in quality of life,” said Mark Pimentel, MD, FRCPC, executive director of the Medically Associated Science and Technology (MAST) program at Cedars-Sinai. The patent rights covering the use of NB-1001 are owned by Cedars-Sinai Medical Center and are exclusively licensed by Cedars-Sinai to Naia.
- Daniel Perez, M.D., co-founder, chairman and CEO of Naia Rare Diseases, said, “The potential behind the combination of these companies is powerful. We believe the high-caliber, experienced team will advance our exciting pipeline, as they share our commitment of bringing innovative new medicines to patients suffering from SBS and other debilitating gastrointestinal rare diseases with few options.”
According to the National Institute of Diabetes, and Digestive and Kidney Diseases (NIDDK), SBS is a rare syndrome of problems related to poor absorption of nutrients as a result of at least half of the small intestine being removed and sometimes all or part of the large intestine; significant damage to the small intestine; or poor motility, or movement inside of the intestines.2 The incidence of SBS is poorly known but estimated at about 5 to 10 patients per year per million population. In adults, the incidence of SBS requiring at-home parenteral nutrition is estimated at two adult patients per year per million population.3 The only approved pharmacologic therapies for SBS include trophic factors, such as short-acting daily injectable GLP-2 analogues, which may not be appropriate for all patient types.
Pursuant to the LOI, the combined company will acquire all of the outstanding capital stock of Naia in exchange for an undisclosed amount of cash and equity. The Naia acquisition would be expected to close after the merger of RDD and Innovate to create 9 Meters Biopharma, Inc. Closing is subject to the negotiation of a definitive agreement, customary legal and regulatory clearances and procedures. The corporate headquarters for the combined company will be located in Raleigh, North Carolina. Wyrick Robbins Yates & Ponton LLP and Shibolet & Co. are serving as legal counsel to RDD, and Dorsey and Whitney LLP is serving as legal counsel to Naia.
Naia Rare Diseases is a development stage biopharmaceutical company developing novel drugs for rare gastrointestinal disorders. The company is pursuing three development programs including NB 1001 for Adult SBS, NB 1001 for pediatric SBS and NB 1002, a GLP-2 agonist, for an undisclosed orphan gastrointestinal indication. Naia Rare Diseases has been funded by an international syndicate of private investors, and was founded by Naia Limited, a company focused on building new biotech companies using de-risked clinical stage assets.
Source: Company Press Release