CURE Pharma open to US CRO contract in February 2019 for PK/bioavailability study for thin film sildenafil, updates NASDAQ up-listing and partnering plans, CEO says
CURE Pharmaceuticals (OTC:CURR) welcomes CRO approaches in February 2019 for a pharmacokinetic/bioavailability study of its thin film formulation of sildenafil for erectile dysfunction, said CEO Robert Davidson. Once the Oxnard, California-based company has completed its pre-IND meeting—planned for either the end of December 2018 or January 2019 —it would have a better sense of the scope of study, including size and study population, and would be able to ramp up discussions then, he said.
The CRO should be US-based and have familiarity with clinical development of drugs via the 505(b)(2) pathway, Davidson said. CURE is agnostic to size of CRO, and is open to working with multiple specialized CROs rather than a single full-service CRO, he said, adding there is no set date to lock in a CRO yet.
If the pre-IND meeting goes according to schedule, CURE intends to file its IND by 2Q19, and clinical development would hopefully begin in 2019 as well, Davidson said. CURE has been working on the program—tentatively called sildenafil CUREfilm—over the past 24 months and has completed its scalability work, feasibility formulation and flavor systems for its IND filing, Davidson said, adding it intends to move as quickly as possible with this program. He added that as sildenafil is going off-patent and is a well-established drug, the company hopes to be able to bring sildenafil CUREfilm to market with just one or two clinical trials.
Financing and partnership plans
CURE aims to raise USD 8-10m in equity in 1Q19 to fund development of sildenafil CUREfilm and other assets, Davidson said. The company has submitted an application to uplist to the NADSAQ stock exchange and hopes to be uplisted by 2Q19, said Davidson. CURE filed its S-1 on 30 November, which stated it is offering 2m shares priced between USD 5-7 for potential net proceeds of USD 10.5m after commissions and expenses, Davidson said. New Jersey-based Network 1 Financial Securities is its sole bookrunner, he added. CURE anticipates announcing some big milestones in the near future to assist with the raise, he said, declining to disclose details. Analyst reports have noted that at the midpoint of the proposed range, CURE could be valued at USD 78m. CURE currently has a market cap of USD 39.5m.
While CURE has the capability to run clinical development by itself, it is looking for distribution partners of sildenafil CUREfilm and CUREfilm D, a 50,000 IU vitamin D product, Davidson said. For sildenafil CUREfilm, CURE is looking for partners with distribution and sales force channels familiar with generics, and while the company is open to talking with potential partners now, it would anticipate ramping up those discussions when it has obtained some data from its clinical trials, he said. Similarly, CURE is looking for Latin American, European and US distribution partners for CUREfilm D, and for US partners in particular; they should have strong direct-to-physician distribution networks, Davidson said.
As a partnership-driven company, CURE is always open to talking with companies that are interested in adapting its thin film technology for their molecules, said Davidson, pointing out a recent partnership with Canopy Growth (NYSE:CGC) for thin film formulations of cannabinoids. The partnership was announced in September, and CURE is building out Canpoy’s full drug delivery portfolio, and is currently optimizing the formulation and flavor profile of several different cannabinoid molecules in a few indications for clinical trials, he said, declining to disclose the indications but noting some of them are CNS disorders or in pain. The clinical trials should be initiated in 2019 for some of them, Davidson said.