REHOVOT, Israel and BRIDGEWATER, N.J., March 03, 2016 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX), (“Foamix Pharmaceuticals”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced today financial results for the twelve months ended December 31, 2015.
“We have made significant progress with our lead clinical development programs,” said Dr. Dov Tamarkin, Chief Executive Officer of Foamix Pharmaceuticals. “Most importantly, FMX101 is now on track to initiating Phase III clinical trials in moderate-to-severe acne; and the enrollment of moderate-to-severe papulopustular rosacea patients is well underway in our FMX103 Phase II study. Our cash position provides sufficient funds to execute on our current plans for FMX101 and FMX103, as well as our other programs, FMX102 and FDX104.”
Financial Highlights for the Twelve Months Ended December 31, 2015:
- Total revenues were $0.9 million compared with $5.4 million for the twelve months ended December 31, 2014.
- Research and development expenses were $10.7 million, compared with $3.6 million in the twelve months ended December 31, 2014.
- Operating expenses totaled $17.7 million compared with $6.5 million in the twelve months ended December 31, 2014.
- Operating loss was $16.9 million compared with an operating loss of $1.6 million in the twelve months ended December 31, 2014.
- Net loss was $16.5 million, or $0.58 per share, basic and diluted, compared with $11.5 million or $0.79 per share, basic and diluted, for the twelve months ended December 30, 2014.
- At December 31 2015, Foamix had cash, cash equivalents, bank deposits and investments in marketable securities of $103.8 million, compared with $50.0 million at December 31, 2014.
- As of December 31, 2015 Foamix was entitled to a royalty payment from Bayer Healthcare in an amount of $253,000. This royalty payment was based on net sales in the 4th quarter of 2015 for Finacea® Foam, a prescription product for the treatment of rosacea that was developed in collaboration with Bayer.
Fourth Quarter 2015 & R&D Update
- In October 2015, we enrolled the first patient into a double-blind, randomized, placebo-controlled Phase II clinical trial of FMX103 for the treatment of moderate-to-severe papulopustular rosacea.
- The trial is designed to enroll up to 210 patients, and will be conducted in 16 sites throughout Germany.
- Over 50% of patients have been enrolled to date.
- In December 2015, we announced positive top-line results from the Phase II study of FDX104 in the prevention of acneiform rash associated with targeted antibody treatments for colon and head & neck cancers.
- The results showed a statistically significant effect of FDX104 in reducing the frequency of occurrence of moderate-to-severe rash in patients treated with targeted antibodies.
- FDX104 appeared safe and well-tolerated. No drug-related systemic adverse events were recorded.
- In January we announced the successful completion of a Phase I bridging study (MUSE) with FMX101 to support the planned Phase III clinical trials in the U.S.
- The study compared minocycline bioavailability of FMX101 to Solodyn® (minocycline HCl) extended-release tablets, 1mg/kg orally.
- The bioavailability (systemic exposure) following daily administration of the 4 gram MUSE dose of FMX101 for 21 days was approximately 700 times lower than that following a single oral dose of Solodyn
- FMX101 was well tolerated, with no severe or drug related adverse events.
- In early February we commenced a long-term (39-week) toxicology study with FMX101. The company anticipates dosing of the active phase in this trial should be completed by year end 2016.
- In mid-February we completed an End-of-Phase II meeting with the FDA regarding the clinical development plan for FMX101.
- The company is implementing comments from the FDA regarding overall study design, primary efficacy endpoints and safety assessments for the Phase III program.
- The Phase III program is expected to incorporate two double-blind placebo controlled trials, run in parallel, each enrolling 450 patients (2:1 randomization - active vs placebo).
- The company intends to commence the Phase III trials and begin dosing patients in the second quarter of 2016.
- Enrollment of the efficacy portion of the Phase III trials is expected to be complete by year end 2016.
- We completed manufacturing of the FMX101 Phase III clinical supplies, and all supplies have been shipped to the U.S. for packaging and randomization for the Phase III trials.
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About Foamix Pharmaceuticals Ltd.
Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy. Our clinical stage product candidates include FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne, FMX102 for the treatment of impetigo, FMX 103 for the treatment of rosacea, and FDX104, our doxycycline foam for the management of acne-like rash, induced by EGFRI anticancer drugs.
In addition, we have development and license agreements relating to our technology with various pharmaceutical companies including Bayer HealthCare, Merz, Allergan and Prestium. For more information, please visit www.foamixpharma.com.
Finacea® is a registered trademark of Bayer HealthCare
Solodyn® is a registered trademark of Valeant Pharmaceuticals
Consolidated Statement of Operations Data – Year Ended December 31
(in thousands of U.S. dollars, except per share data)
|Year ended December 31,|
|Statements of operations data:|
|Cost of revenues||70||527||453||491|
|Research and development(1)||10,680||3,557||1,086||1,202|
|Selling, general and administrative(1)||7,029||2,964||1,221||953|
|Total operating expenses||17,709||6,521||2,307||2,155|
|Loss per share basic and diluted||0.58||0.79||0.22||0.20|
Consolidated Balance Sheet Data – Year Ended December 31
(in thousands of U.S. dollars)
|As of December 31,|
|Balance sheet data:|
|Cash, cash equivalents, bank deposits and investment in marketable securities||$||103,779||$||49,966||$||2,308||$||950|
|Total long-term liabilities||385||381||4,917||3,967|
|Total shareholders’ equity (capital deficiency)||100,802||48,762||(3,582||)||(2,941||)|
|Number of ordinary shares||30,639,134||22,443,934||11,408,490||11,151,719|