Sol-Gel Technologies Reports Third Quarter 2018 Financial Results
“The third quarter was very busy as we made advancements on both the branded and generic pipelines.
Corporate Highlights and Recent Developments
- The Company announced it entered into two collaborative agreements with Perrigo Israel, an affiliate of
Perrigo Company plc("Perrigo") (NYSE; TASE: PRGO); one in November and one in August. The agreements are each for the development, manufacturing and commercialization of a generic product candidate. Under the terms of the agreements, Perrigowill seek regulatory approval with the U.S. Food and Drug Administration(“FDA”) for these generic product candidates.
September 2018, Sol-Gelannounced it had completed enrollment of half of the patients in its pivotal Phase III clinical trials of Epsolay in subjects with papulopustular rosacea (also known as subtype II rosacea). The pivotal Phase III clinical program is being conducted in accordance with Special Protocol Assessment (“SPA”) agreements with the FDAand consists of two randomized, multi-center, double-blind, vehicle-controlled clinical trials at 50 sites in the United States.
September 2018, Sol-Gelannounced the addition of Jonathan B. Siegelto the Company’s board of directors.
September 2018, Sol-Gelannounced that it had completed an End-of-Phase II meeting with the FDAfor TWIN in the treatment of acne vulgaris. The Company also announced that it had reached an agreement with the FDAregarding an SPA for TWIN. The SPA provides agreement that the protocol design, clinical endpoints and statistical analysis approach for Sol-Gel’s Phase III program evaluating TWIN for the treatment of patients with acne vulgaris will be deemed adequate to support a New Drug Application filing for marketing approval.
Clinical Program Update
Sol-Gelexpects to commence the pivotal Phase III clinical trials evaluating the safety and efficacy of TWIN in subjects with acne vulgaris in the fourth quarter of 2018.
Sol-Gelplans to commence a bioequivalence study for a generic product candidate in the fourth quarter of 2018.
Sol-Gelexpects to report top-line data from the pivotal Phase III clinical programs for Epsolay and TWIN in 2019.
Financial results for the three months ended
Research and development expenses were
General and administrative expenses were
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statement, including but not limited to, the following: the fact that we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our ability to complete the development of our product candidates; our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; our ability to rely on data from our Phase II TWIN trial to advance the development of SIRS-T; our ability to commercialize our product candidates; our ability to obtain and maintain adequate protection of our intellectual property; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; acceptance of our product candidates by healthcare professionals and patients; the possibility that we may face third-party claims of intellectual property infringement; the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; potential product liability claims; potential adverse federal, state and local government regulation in
(U.S. dollars in thousands, except share and per share data)
|A s s e t s|
|Cash and cash equivalents||$||5,024||$||13,267|
|Prepaid expenses and other current assets||1,511||3,390|
|TOTAL CURRENT ASSETS||10,548||76,981|
|Restricted long-term deposits||120||466|
|Property and equipment, net||2,314||2,520|
|Funds in respect of employee rights upon retirement||680||650|
|TOTAL NON-CURRENT ASSETS||4,767||3,663|
|Liabilities and shareholders' equity (of capital deficiency)|
|Accrued expenses and other||1332||1,468|
|Loans from the controlling shareholder||65,338||-|
|TOTAL CURRENT LIABILITIES||$||67,204||$||4,823|
|LONG-TERM LIABILITIES -|
|Liability for employee rights upon retirement||810||907|
|TOTAL LONG-TERM LIABILITIES||810||907|
|SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY):|
|Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2017 and September 30, 2018; issued and outstanding: 6,290,244 and 18,949,968 as of December 31, 2017 and September 30, 2018, respectively||82||520|
|Additional paid-in capital||42,480||189,982|
|TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)||(52,699||)||74,914|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)||$||15,315||$||80,644|
STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
||Nine months ended
|Three months ended
|Research and development||21,389||17,545||12,013||7,083|
|General and administrative||4,781||3,974||2,321||1,314|
|TOTAL OPERATING LOSS||26,170||21,388||14,334||8,359|
|FINANCIAL INCOME, net||(52||)||(1,061||)||(48||)||(652||)|
|LOSS FOR THE PERIOD||$||26,118||$||20,327||$||14,286||$||7,707|
|BASIC AND DILUTED LOSS PER ORDINARY SHARE||$||4.15||$||1.16||$||2.27||$||0.40|
|WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE||6,290,244||17,501,491||6,290,244||18,949,968|
For further information, please contact:
Chief Financial Officer
Source: Sol-Gel Technologies Ltd.