Release Details
Sol-Gel Technologies Reports Second Quarter 2018 Financial Results
NESS ZIONA,
“The highlight of the second quarter was the initiation of our pivotal Phase III clinical program for Epsolay® which marks a significant achievement for Sol-Gel,” commented Dr.
Corporate Highlights and Recent Developments
- In
June 2018 ,Sol-Gel announced dosing of the first subject in the pivotal Phase III clinical program evaluating the safety and efficacy of Epsolay (formerly VERED) in subjects with papulopustular rosacea (also known as subtype II rosacea). The pivotal Phase III clinical program is being conducted in accordance with a SPA agreement with theFDA regarding the design of the pivotal trials and the enrollment of patients is progressing as planned. Papulopustular rosacea is a chronic, inflammatory skin condition that most often affects the face. Epsolay is a once-daily topical cream containing encapsulated benzoyl peroxide, 5%, using Sol-Gel’s proprietary microencapsulation technology.
Clinical Program Update
Sol-Gel expects to commence the pivotal Phase III clinical trials evaluating the safety and efficacy of TWIN in subjects with acne vulgaris in the the fourth quarter of 2018.
Sol-Gel plans to commence a bioequivalence study for a generic product candidate in the fourth quarter of 2018.
Sol-Gel expects to report top-line data from the pivotal Phase III clinical program for Epsolay and TWIN in 2019.
Financial results for the three months ended
Research and development expenses were $5.8 million in the second quarter of 2018, compared to $4.4 million during the same period in 2017. The increase was primarily due to an increase in manufacturing expenses of
General and administrative expenses were $1.5 million in the second quarter of 2018, compared to $1.8 million during the same period in 2017. The decrease was primarily due to a decrease of
As of June 30, 2018,
About
Forward-Looking Statements
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, including statements regarding the commencement of our planned clinical trials for TWIN, the commencement of our planned bioequivalence study for a generic product candidate and our expected date to report top-line data from our pivotal Phase III clinical program for Epsolay® and TWIN. 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
| SOL-GEL TECHNOLOGIES LTD. | ||||||
| BALANCE SHEETS | ||||||
| (U.S. dollars in thousands, except share and per share data) | ||||||
| (Unaudited) | ||||||
| December 31, |
June 30, |
|||||
| 2017 |
2018 | |||||
| A s s e t s | ||||||
| CURRENT ASSETS: | ||||||
| Cash and cash equivalents | $ | 5,024 | $ | 18,240 | ||
| Bank deposit | 4,000 | 1,000 | ||||
| Prepaid expenses and other current assets | 1,511 | 2,443 | ||||
| Marketable securities | - | 59,407 | ||||
| Advance payment | 13 | 72 | ||||
| TOTAL CURRENT ASSETS | 10,548 | 81,162 | ||||
| NON-CURRENT ASSETS: | ||||||
| Long-term receivables | 1,653 | 1,604 | ||||
| Restricted long-term deposits | 120 | 465 | ||||
| Property and equipment, net | 2,314 | 2,478 | ||||
| Funds in respect of employee rights upon retirement | 680 | 646 | ||||
| TOTAL NON-CURRENT ASSETS | 4,767 | 5,193 | ||||
| TOTAL ASSETS | $ | 15,315 | $ | 86,355 | ||
| Liabilities and shareholders' equity (capital deficiency) | ||||||
| CURRENT LIABILITIES: | ||||||
| Accounts payable | 534 | 1,884 | ||||
| Accrued expenses and other | 1,332 | 2,024 | ||||
| Loans from the controlling shareholder | 65,338 | - | ||||
| TOTAL CURRENT LIABILITIES | $ | 67,204 | $ | 3,908 | ||
| LONG-TERM LIABILITIES - | ||||||
| Liability for employee rights upon retirement | 810 | 901 | ||||
| TOTAL LONG-TERM LIABILITIES | 810 | 901 | ||||
| COMMITMENTS | ||||||
| TOTAL LIABILITIES | $ | 68,014 | $ | 4,809 | ||
| CAPITAL DEFICIENCY: | ||||||
| Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2017 and June 30, 2018; issued and outstanding: 6,290,244 and 18,949,968 as of December 31, 2017 and June 30, 2018, respectively | 82 | 520 | ||||
| Additional paid-in capital | 42,480 | 188,907 | ||||
| Accumulated deficit | (95,261) | (107,881) | ||||
| TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) | (52,699) | 81,546 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) | $ | 15,315 | $ | 86,355 | ||
| SOL-GEL TECHNOLOGIES LTD. | |||||||||||||
| STATEMENTS OF OPERATIONS | |||||||||||||
| (U.S. dollars in thousands, except share and per share data) | |||||||||||||
| (Unaudited) | |||||||||||||
| |
Six months ended June 30 |
Three months ended June 30 |
|||||||||||
| 2017 | 2018 | 2017 | 2018 | ||||||||||
| REVENUES | $ | (93) | $ | (49) | |||||||||
| RESEARCH AND DEVELOPMENT EXPENSES | $ | 9,376 | $ | 10,462 | $ | 4,359 | 5,817 | ||||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 2,460 | 2,660 | 1,849 | 1,518 | |||||||||
| TOTAL OPERATING LOSS | 11,836 | 13,029 | 6,208 | 7,286 | |||||||||
| FINANCIAL INCOME, net | (4) | (409) | (6) | (379) | |||||||||
| LOSS FOR THE PERIOD | $ | 11,832 | $ | 12,620 | $ | 6,202 | $ | 6,907 | |||||
| BASIC AND DILUTED LOSS PER ORDINARY SHARE | $ | 1.88 | $ | 0.75 | $ | 0.98 | $ | 0.36 | |||||
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE | 6,290,242 | 16,761,158 | 6,290,242 | 18,949,968 | |||||||||
For further information, please contact:
Sol-Gel Contact:
Chief Financial Officer
+972-8-9313433
Investor Contact:
Westwicke Partners
+1-415-513-1284
[email protected]
Source: Sol-Gel Technologies Ltd.