REHOVOT, Israel, Aug. 19, 2015 (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, announces financial results for the three and six months ended June 30, 2015.
Financial highlights for the second quarter ended June 30, 2015:
- Total revenues were $109,000 compared with $598,000 for the three months ended June 30, 2014. The reduction was due to completion of certain development projects for our licensees that generated development fees during 2014, and which resulting products are now in clinical trial phases or pending commercialization and therefore are not generating development fees at this time.
- Research and development expenses were $2.8 million, compared with $353,000 in the three months ended June 30, 2014. The increase in research and development expenses was related to our efforts and preparation towards the launch of the clinical trials for FMX101, our lead product candidate for treatment of moderate-to-severe acne, and FMX103, our lead product candidate for treatment of papulopustular rosacea.
- Selling, general and administrative expenses were $2.0 million, compared with $409,000 in the three months ended June 30, 2014.
- Total operating expenses were $4.8 million, compared with $762,000 in the three months ended June 30, 2014.
- Net loss in the second quarter was $4.6 million or $0.18 per share, basic and diluted, compared with a loss of $3.4 million or $0.30 per share, basic and diluted, for the three months ended June 30, 2014.
- Cash, cash equivalents and short and long-term investments at June 30, 2015 totaled $110.8 million, compared with approximately $50 million at December 31, 2014.
- On April 20, 2015 we completed a successful follow-on public offering at a price per share of $9.30, raising $69 million including the exercise of the underwriters’ option to purchase an additional 967,741 shares. Net proceeds, after expenses and underwriter fees, totaled $64.2 million.
Financial highlights for the six months ended June 30, 2015:
- Revenues were $557,000 compared with $2.0 million for the six months ended June 30, 2014.
- Research and development expenses were $4.9 million compared with $702,000 in the six months ended June 30, 2014.
- Operating expenses totaled $8.3 million compared with $1.6 million in the six months ended June 30, 2014.
- Operating loss was $7.8 million compared with an operating income of $144,000 in the six months ended June 30, 2014.
- Net loss was $7.7 million or $0.30 per basic and diluted share compared with $3.5 million or $0.30 per basic and diluted share for the six months ended June 30, 2014.
Clinical, business and corporate developments for the period December 31, 2014 to date:
- Clinical supplies for the Phase I Bridging/Maximal Use (MUSE) trial for FMX101 have been manufactured and shipped to the U.S. The trial is expected to commence in early September.
- We maintain our expectation to initiate our Phase III clinical trials for FMX101 in moderate to severe acne in early 2016, and complete Phase III in 2017.
- A clinical trial application (CTA) was submitted to BfArM (Federal Institute for Drugs and Medical Devices in Germany) to conduct a Phase II trial in Germany for FMX103 in rosacea. Clinical supplies have been produced and we expect to initiate the trial later this year.
- We completed enrollment of patients for our Phase II trial with FDX104, our novel topical foam formulation of doxycycline for treatment of chemotherapy-induced rash in cancer patients taking epidermal growth factor receptor inhibitors (EGFRI) such as Erbitux® and Vectibix®. We expect to present top line results from the trial in the fourth quarter.
- An end-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) regarding the clinical development plan for FMX102, our minocycline foam product for the treatment of impetigo, has been scheduled for mid-October.
- On July 31, 2015, Bayer Healthcare announced that it had received FDA approval for Finacea® Foam (azelaic acid 15%), a prescription foam product which was developed by Foamix in collaboration with Bayer. This is the first prescription product developed using our proprietary technology to be FDA-approved for sale in the U.S. According to our license agreement with Bayer, we are entitled to royalties and certain milestone payments upon commercialization of Finacea Foam.
- We continue to advance our intellectual property estate. As of July 31, 2015, we have over 120 granted patents worldwide, including 41 granted patents in the United States.
Management Overview
We had a productive first half of 2015 and achieved a number of important milestones in advancing our pipeline of novel foam-based product candidates for various dermatological conditions. We also strengthened our balance sheet through a successful follow-on public offering which generated net proceeds of $64.2 million.
In June 2015 we provided an updated estimated schedule for the clinical trials of our lead product candidate FMX101, our proprietary minocycline foam product for the treatment of moderate-to-severe acne vulgaris. We have successfully manufactured and shipped to the U.S. the clinical supplies required for the Phase I bridging trial that we expect to commence in September. Based on our on-going progress, we maintain our expectation to initiate our Phase III clinical trials for FMX101 in early 2016, and complete Phase III in 2017.
FMX101 has the potential to be the first clinically viable topical formulation of minocycline. Foamix is pursuing approval for FMX101 in the U.S. under the abbreviated 505(b)(2) pathway.
For FMX103, we recently submitted a clinical trial application (CTA) to the German clinical and regulatory authorities for final review and approval to conduct a Phase II trial in rosacea. Clinical supplies for the trial have been produced and shipped, and we expect to initiate the trial later this year.
Rosacea is a chronic skin disorder, characterized by facial redness and inflammatory lesions, afflicting about 16 million people in the U.S. alone. The most common treatments for rosacea are oral minocycline and doxycycline, such as Oracea. Based on our clinical data for acne and the dermatological similarities between rosacea lesions and inflammatory acne lesions, we expect FMX103 to be a safe and effective treatment for rosacea.
With respect to the clinical development plan for FMX102, our minocycline foam product for the treatment of impetigo, an end-of-Phase II meeting with the FDA has been scheduled for mid-October. Based on the FDA’s guidance, we intend to continue our development of FMX102.
With respect to FDX104, we are currently conducting a Phase II clinical trial on a multi-center, vehicle controlled, double-blind basis to evaluate the safety, tolerability and efficacy of this product. We have completed enrollment of patients for this trial and we expect to present top line results from the trial in the fourth quarter.
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