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SOL-GEL TECHNOLOGIES LTD.
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Date: November 13, 2018
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By:
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/s/ Gilad Mamlok
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Gilad Mamlok
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Chief Financial Officer
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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, Perrigo will seek regulatory approval with the U.S. Food and Drug Administration (“FDA”) for these generic product candidates.
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In September 2018, Sol-Gel announced 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 FDA and consists of two randomized, multi-center, double-blind, vehicle-controlled clinical trials at 50 sites in the United States.
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In September 2018, Sol-Gel announced the addition of Jonathan B. Siegel to the Company’s board of directors.
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In September 2018, Sol-Gel announced that it had completed an End-of-Phase II meeting with the FDA for TWIN in the treatment of acne vulgaris. The Company also announced that it had reached an agreement with the FDA regarding 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.
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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 fourth quarter of 2018.
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Sol-Gel plans to commence a bioequivalence study for a generic product candidate in the fourth quarter of 2018.
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Sol-Gel expects to report top-line data from the pivotal Phase III clinical programs for Epsolay and TWIN in 2019.
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December 31,
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September 30,
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|||||||
2017
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2018
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A s s e t s
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CURRENT ASSETS:
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Cash and cash equivalents
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$
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5,024
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$
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13,267
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Bank deposit
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4,000
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1,000
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Prepaid expenses and other current assets
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1,511
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3,390
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Marketable securities
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‐
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59,202
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Advance payment
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13
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122
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TOTAL CURRENT ASSETS
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10,548
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76,981
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NON‐CURRENT ASSETS:
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Long‐term receivables
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1,653
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27
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Restricted long‐term deposits
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120
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466
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Property and equipment, net
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2,314
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2,520
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Funds in respect of employee rights upon retirement
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680
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650
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TOTAL NON‐CURRENT ASSETS
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4,767
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3,663
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TOTAL ASSETS
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$
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15,315
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$
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80,644
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Liabilities and shareholdersʹ equity (of capital deficiency)
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||||||||
CURRENT LIABILITIES:
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Accounts payable
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534
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3,355
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Accrued expenses and other
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1,332
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1,468
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Loans from the controlling shareholder
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65,338
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‐
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TOTAL CURRENT LIABILITIES
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$
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67,204
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$
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4,823
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LONG‐TERM LIABILITIES ‐
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Liability for employee rights upon retirement
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810
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907
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TOTAL LONG‐TERM LIABILITIES
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810
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907
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COMMITMENTS
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TOTAL LIABILITIES
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$
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68,014
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$
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5,730
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SHAREHOLDERSʹ EQUITY (CAPITAL DEFICIENCY):
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Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000
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as of December 31, 2017 and September 30, 2018; issued and outstanding: 6,290,244 and 18,949,968 as of
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December 31, 2017 and September 30, 2018, respectiveley
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82
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520
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Additional paid‐in capital
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42,480
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189,982
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Accumulated deficit
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(95,261
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)
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(115,588
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)
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TOTAL SHAREHOLDERSʹ EQUITY (CAPITAL DEFICIENCY)
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(52,699
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)
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74,914
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TOTAL LIABILITIES AND SHAREHOLDERSʹ EQUITY (CAPITAL DEFICIENCY)
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$
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15,315
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$
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80,644
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Nine months ended
September 30
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Three months ended
September 30
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2017 | 2018 | 2017 | 2018 | |||||||||||||
REVENUES | - | $ | 131 | - | $ | 38 | ||||||||||
OPERATING EXPENSES | ||||||||||||||||
Research and development
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21,389
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17,545
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12,013
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7,083
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General and administrative
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4,781 |
3,974
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2,321
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1,314
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TOTAL OPERATING LOSS |
26,170
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21,388
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14,334
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8,359
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FINANCIAL INCOME, net | (52 | ) |
(1,061
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)
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(48
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)
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(652
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)
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LOSS FOR THE PERIOD
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$
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26,118
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$
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20,327
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14,286
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$
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7,707
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BASIC AND DILUTED LOSS PER ORDINARY SHARE |
$
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4.15
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$
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1.16
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$
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2.27
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$
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0.40
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WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF
BASIC AND DILUTED LOSS PER SHARE
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6,290,244
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17,501,491
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6,290,244
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18,949,968
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