|
State of Israel
|
| |
2834
|
| |
Not Applicable
|
|
|
(State or Other Jurisdiction of
Incorporation or Organization) |
| |
(Primary Standard Industrial
Classification Code Number) |
| |
(I.R.S. Employer Identification No.)
|
|
|
Joshua G. Kiernan
Nathan Ajiashvili Latham & Watkins LLP 99 Bishopsgate Museum Tower London EC2M 3XF United Kingdom Tel: +44-20-7710-5820 Fax: +44-20-7374-4460 |
| |
Daniel Kleinhendler
Gross, Kleinhendler, Hodak, Halevy, Greenberg & Co. One Azrieli Center Tel Aviv 67021, Israel Tel: +972-3-607-4444 Fax: +972-3-607-4470 |
|
| | ||||||||||||
Title of each Class of Securities to be Registered
|
| |
Proposed Maximum
Aggregate Offering Price (1)(2) |
| |
Amount of
Registration Fee (3) |
| ||||||
Ordinary shares, par value NIS 0.1 per share
|
| | | $ | | | | | $ | | | ||
|
| | |
Per
share |
| |
Total
|
| ||||||
Initial public offering price
|
| | | $ | | | | | $ | | | ||
Underwriting discounts and commissions (1)
|
| | | $ | | | | | | $ | | | |
Proceeds to us (before expenses)
|
| | | $ | | | | | | $ | | | |
| | | | | 1 | | | |
| | | | | 11 | | | |
| | | | | 55 | | | |
| | | | | 56 | | | |
| | | | | 57 | | | |
| | | | | 58 | | | |
| | | | | 60 | | | |
| | | | | 61 | | | |
| | | | | 62 | | | |
| | | | | 64 | | | |
| | | | | 65 | | | |
| | | | | 78 | | | |
| | | | | 111 | | | |
| | | | | 132 | | | |
| | | | | 134 | | | |
| | | | | 136 | | | |
| | | | | 144 | | | |
| | | | | 146 | | | |
| | | | | 158 | | | |
| | | | | 166 | | | |
| | | | | 167 | | | |
| | | | | 167 | | | |
| | | | | 167 | | | |
| | | | | 169 | | |
Product Candidate
|
| |
Indication
|
| |
Status
|
| |
Upcoming Milestone
|
|
VERED | | | Papulopustular (subtype II) rosacea | | | Preparing for Phase III clinical trial | | | Initiate pivotal Phase III clinical trials first half of 2018 | |
TWIN | | | Acne vulgaris | | | Phase II clinical trial ongoing | | | Top-line Phase II clinical trial results mid-2017 | |
SIRS-T | | | Acne vulgaris | | | Preparing for Phase III clinical trial | | | Initiate Phase III clinical trials second half of 2018 | |
E-06 | | | Symptomatic interdigital tinea pedis | | | Phase II clinical trial ongoing | | | Top-line Phase II clinical trial results second half of 2017 | |
Ivermectin cream, 1% | | | Papulopustular (subtype II) rosacea | | | Bioequivalence study ongoing | | | ANDA submission upon study completion | |
| | |
Year Ended December 31
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
| | |
(in thousands, except share and
per share data ) |
| |||||||||
Statement of Operations Data: | | | | | | | | | | | | | |
Research and development expenses
|
| | | $ | 7,184 | | | | | $ | 17,023 | | |
General and administrative expenses
|
| | | | 2,463 | | | | | | 3,733 | | |
Total operating loss
|
| | | | 9,647 | | | | | | 20,756 | | |
Financial expenses, net
|
| | | | 13 | | | | | | 15 | | |
Loss for the year
|
| | | $ | 9,660 | | | | | $ | 20,771 | | |
Basic and diluted loss per ordinary share (1)
|
| | | $ | 2.76 | | | | | $ | 5.94 | | |
Weighted average number of ordinary shares outstanding – basic and diluted
|
| | | | 3,494,579 | | | | | | 3,494,579 | | |
|
| | |
As of December 31, 2016
|
| |||||||||
| | |
Actual
|
| |
As
Adjusted (1) |
| ||||||
| | |
(in thousands)
|
| |||||||||
Balance Sheet Data: | | | | ||||||||||
Cash and cash equivalents
|
| | | $ | 7,001 | | | | | $ | | | |
Total assets
|
| | | | 10,985 | | | | | | | | |
Total liabilities
|
| | | | 42,322 | | | | | | | | |
Accumulated deficit
|
| | | | (63,693) | | | | | | | | |
Total capital deficiency
|
| | | | (31,337) | | | | | | | | |
| | |
As of December 31, 2016
|
| |||||||||
| | |
Actual
|
| |
As Adjusted
|
| ||||||
| | |
(in thousands,
except share and per share data) |
| |||||||||
Cash and cash equivalents
|
| | | $ | 7,001 | | | | | $ | | | |
Loans from the controlling shareholder
|
| | | $ | 37,338 | | | | | $ | | | |
Shareholders’ equity (capital deficiency): | | | | ||||||||||
Ordinary shares of NIS 0.1 par value per share; 8,775,783 shares authorized and 3,494,579 shares issued and outstanding, actual; shares authorized and issued and outstanding, as adjusted
|
| | | | 82 | | | | |||||
Additional paid-in capital
|
| | | | 32,274 | | | | |||||
Accumulated deficit
|
| | | | (63,693) | | | | | | | | |
Total capital deficiency
|
| | | | (31,337) | | | | | | | | |
Total capitalization
|
| | | $ | 6,001 | | | | | $ | | | |
|
|
Assumed initial public offering price per ordinary share
|
| | | | | | | | | $ | | | |
|
Net tangible book value (deficit) per ordinary share as of December 31, 2016
|
| | | $ | (8.97) | | | | | | | | |
|
Increase in net tangible book value per ordinary share attributable to the offering
|
| | | $ | | | | | | | | | |
|
As adjusted net tangible book value per share after this offering
|
| | | | | | | | | $ | | | |
|
Dilution per ordinary share to new investors
|
| | | | | | | | | $ | | | |
|
Percentage of dilution per ordinary share to new investors
|
| | | | | | | | | | % | | |
|
| | |
Shares purchased
|
| |
Total consideration
|
| |
Average
price per share |
| ||||||||||||||||||||||||
| | |
Number
|
| |
%
|
| |
Amount
|
| |
%
|
| | | |||||||||||||||||||
Existing shareholder
|
| | | | | | | | | | | | | | | $ | | | | | | | | | | | | $ | | | | | ||
New investors
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||
Total
|
| | | | | | | | | 100 | | | | | $ | | | | | | 100 | | | | | $ | | | | |||||
|
| | |
Year Ended December 31,
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
| | |
(in thousands,
except share and per share data) |
| |||||||||
Statement of Operations Data: | | | | ||||||||||
Research and development expenses
|
| | | $ | 7,184 | | | | | $ | 17,023 | | |
General and administrative expenses
|
| | | | 2,463 | | | | | | 3,733 | | |
Total operating loss
|
| | | | 9,647 | | | | | | 20,756 | | |
Financial expenses, net
|
| | | | 13 | | | | | | 15 | | |
Loss for the year
|
| | | $ | 9,660 | | | | | $ | 20,771 | | |
Basic and diluted loss per ordinary share (1)
|
| | | $ | 2.76 | | | | | $ | 5,94 | | |
Weighted average number of ordinary shares outstanding – basic and
diluted |
| | | | 3,494,579 | | | | | | 3,494,579 | | |
|
| | |
As of December 31,
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
| | |
(in thousands)
|
| |||||||||
Balance Sheet Data: | | | | ||||||||||
Cash and cash equivalents
|
| | | $ | 5,895 | | | | | $ | 7,001 | | |
Total assets
|
| | | | 8,244 | | | | | | 10,985 | | |
Total liabilities
|
| | | | 19,762 | | | | | | 42,322 | | |
Accumulated deficit
|
| | | | (42,922) | | | | | | (63,693) | | |
Total capital deficiency
|
| | | | (11,518) | | | | | | (31,337) | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
| | |
(in thousands)
|
| |||||||||
Research and development expenses
|
| | | $ | 7,184 | | | | | $ | 17,023 | | |
General and administrative expenses
|
| | | | 2,463 | | | | | | 3,733 | | |
Total operating loss
|
| | | | 9,647 | | | | | | 20,756 | | |
Financial expenses, net
|
| | | | 13 | | | | | | 15 | | |
Loss for the year
|
| | | $ | 9,660 | | | | | $ | 20,771 | | |
|
| | |
Year Ended December 31,
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
| | |
(in thousands)
|
| |||||||||
Payroll and related expenses
|
| | | $ | 2,647 | | | | | $ | 3,629 | | |
Clinical trials expenses
|
| | | | 517 | | | | | | 9,686 | | |
Professional consulting and subcontracted work
|
| | | | 2,001 | | | | | | 1,830 | | |
In-process research and development acquired
|
| | | | 431 | | | | | | — | | |
Other
|
| | | | 1,588 | | | | | | 1,878 | | |
Total research and development expenses
|
| | | $ | 7,184 | | | | | $ | 17,023 | | |
|
| | |
Year Ended December 31,
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
| | |
(in thousands)
|
| |||||||||
Net cash used in operating activities
|
| | | $ | (8,044) | | | | | $ | (18,495) | | |
Net cash used in investing activities
|
| | | | (210) | | | | | | (391) | | |
Net cash from financing activities
|
| | | | 13,572 | | | | | | 20,000 | | |
Increase in cash and cash equivalents
|
| | | $ | 5,301 | | | | | $ | 1,106 | | |
|
| | |
Total
|
| |
Less than
1 year |
| |
1 – 3 years
|
| |
3 – 5 years
|
| |
More than
5 years |
| |||||||||||||||
| | |
(in thousands)
|
| |||||||||||||||||||||||||||
Operating leases obligations (1)
|
| | | $ | 1,705 | | | | | $ | 419 | | | | | $ | 1,286 | | | | | $ | — | | | | | $ | — | | |
Total
|
| | | $ | 1,705 | | | | | $ | 419 | | | | | $ | 1,286 | | | | | $ | — | | | | | $ | — | | |
|
| | |
2015
|
| |
2016
|
|
Value of one ordinary share
|
| |
$11.35
|
| |
$21.59
|
|
Dividend yield
|
| |
0%
|
| |
0%
|
|
Expected volatility
|
| |
62.46% – 66.22%
|
| |
68.45% – 79.1%
|
|
Risk-free interest rate
|
| |
1.61% – 1.81%
|
| |
0.95% – 1.34%
|
|
Expected term
|
| |
5.5 – 7.5 years
|
| |
5 – 6.71 years
|
|
|
Date of grant
|
| |
Number of
shares subject to awards granted |
| |
Class of
shares subject to the awards granted |
| |
Type of
equity instrument awarded |
| |
Exercise
price per share |
| |
Estimated
fair value per ordinary share at grant date |
| |||||||||||||||
March 29, 2015
|
| | | | 151,299 | | | | | | ordinary | | | | | | options | | | | | $ | 2.86 | | | | | $ | 11.35 | | |
April 12, 2015
|
| | | | 22,141 | | | | | | ordinary | | | | | | options | | | | | $ | 2.86 | | | | | $ | 11.35 | | |
August 2, 2016
|
| | | | 50,422 | | | | | | ordinary | | | | | | options | | | | | $ | 2.86 | | | | | $ | 21.59 | | |
February 12, 2017
|
| | | | 29,906 | | | | | | ordinary | | | | | | options | | | | | $ | 2.86 | | | | | | | | |
Product Candidate
|
| |
Indication
|
| |
Status
|
| |
Upcoming Milestone
|
|
VERED | | | Papulopustular (subtype II) rosacea | | | Preparing for Phase III clinical trial | | | Initiate pivotal Phase III clinical trials first half of 2018 | |
TWIN | | | Acne vulgaris | | | Phase II clinical trial ongoing | | | Top-line Phase II clinical trial results mid-2017 | |
SIRS-T | | | Acne vulgaris | | | Preparing for Phase III clinical trial | | | Initiate Phase III clinical trials second half of 2018 | |
E-06 | | | Symptomatic interdigital tinea pedis | | | Phase II clinical trial ongoing | | | Top-line Phase II clinical trial results second half of 2017 | |
Ivermectin cream, 1% | | | Papulopustular (subtype II) rosacea | | | Bioequivalence study ongoing | | | ANDA submission upon study completion | |
Variable at Week 12
|
| |
Covariate
|
| |
P-value
1% E-BPO vs. Vehicle |
| |
P-value
5% E-BPO vs. Vehicle |
|
Dichotomized IGA (a) | | | Baseline IGA | | |
0.0836(b)
|
| |
0.0013(b)
|
|
Change in inflammatory lesion count
|
| | Baseline IGA Baseline inflammatory lesion count |
| |
0.0049(c)
0.0153(d) |
| |
0.1874(c)
0.1792(d) |
|
Percent change in inflammatory lesion count
|
| | Baseline IGA Baseline inflammatory lesion count |
| |
0.0123(c)
0.0140(d) |
| |
0.0202(c)
0.0200(d) |
|
| | |
Vehicle
(N=30) |
| |
1% E-BPO
(N=32) |
| |
VERED
(N=30) |
|
Week 12 | | | | | ||||||
Dichotomized IGA – Primary Success | | | | | ||||||
Failure
|
| |
24 (80.0%)
|
| |
20 (62.5%)
|
| |
14 (46.7%)
|
|
Success
|
| |
6 (20.0%)
|
| |
12 (37.5%)
|
| |
16 (53.3%)
|
|
Inflammatory Lesion Count – Change from Baseline | | | | | ||||||
Mean
|
| |
-7.4
|
| |
-21.6
|
| |
-14.1
|
|
SD
|
| |
17.24
|
| |
23.31
|
| |
8.78
|
|
Median
|
| |
-10.0
|
| |
-12.5
|
| |
-15.0
|
|
Min. to Max.
|
| |
-45 to 67
|
| |
-94 to -5
|
| |
-34 to 5
|
|
LS Mean (a)
|
| |
-8.8
|
| |
-21.5
|
| |
-14.7
|
|
LS SE (a)
|
| |
3.16
|
| |
3.04
|
| |
3.15
|
|
95% CI for LS Mean (a)
|
| |
[-15.1, -2.5]
|
| |
[-27.5, -15.4]
|
| |
[-21.0, -8.4]
|
|
Area of Activity
|
| |
As of
February 28, 2017 |
| |||
Administrative
|
| | | | 6 | | |
Research, development and quality assurance
|
| | | | 37 | | |
Total
|
| | | | 43 | | |
|
Name
|
| |
Age
|
| |
Position
|
|
Moshe Arkin | | |
64
|
| | Chairman of the Board of Directors | |
Alon Seri-Levy | | |
56
|
| | Chief Executive Officer | |
Gilad Mamlok | | |
49
|
| | Chief Financial Officer | |
Haim Barsimantov | | |
42
|
| | Chief Technology Officer | |
Ofer Toledano | | |
52
|
| | Vice President Research and Development | |
Ofra Levy-Hacham | | |
50
|
| | Vice President Quality and Regulatory Affairs | |
Karine Neimann | | |
45
|
| | Vice President Projects and Planning, Chief Chemist | |
Itzik Yosef | | |
40
|
| | Vice President Operations | |
Dov Zamir | | |
63
|
| | Vice President Special Projects | |
Itai Arkin | | |
28
|
| | Director Nominee | |
Ran Gottfried (1) | | |
72
|
| | External Director Nominee | |
Jerrold S. Gattegno (1) | | |
64
|
| | External Director Nominee | |
| | |
Shares Beneficially
Owned Prior to the Offering |
| |
Shares Beneficially
Owned After the Offering |
| ||||||||||||||||||
Name of Beneficial Owner
|
| |
Number
|
| |
Percentage
|
| |
Number
|
| |
Percentage
|
| ||||||||||||
5% or greater shareholders | | | | | | | | | | | | | | | | | | | | | | | | | |
M.Arkin Dermatology Ltd. (1)
|
| | | | 3,494,579 | | | | | | 100% | | | | | | | | | | | | % | | |
Directors and executive officers | | | | | | ||||||||||||||||||||
Moshe Arkin (1)
|
| | | | 3,494,579 | | | | | | 100% | | | | | | | | | | | | | | |
Alon Seri-Levy (2)
|
| | | | 50,749 | | | | | | 1.5% | | | | | | | | | | | | | | |
Gilad Mamlok
|
| | | | * | | | | | | * | | | | | | * | | | | | | * | | |
Haim Barsimantov
|
| | | | * | | | | | | * | | | | | | * | | | | | | * | | |
Ofer Toledano
|
| | | | * | | | | | | * | | | | | | * | | | | | | * | | |
Ofra Levy-Hacham
|
| | | | * | | | | | | * | | | | | | * | | | | | | * | | |
Karine Neimann
|
| | | | * | | | | | | * | | | | | | * | | | | | | * | | |
Itzik Yosef
|
| | | | * | | | | | | * | | | | | | * | | | | | | * | | |
Dov Zamir
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Gilad Mamlok
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Itai Arkin
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Ran Gottfried
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Jerrold S. Gattegno
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
All directors and executive officers as a group (9 persons) (3)
|
| | | | 3,621,834 | | | | | | 100% | | | | | | | | | | | | % | | |
|
Tax Year
|
| |
Development Region “A”
|
| |
Other Areas within Israel
|
| ||||||
2011 – 2012
|
| | | | 10% | | | | | | 15% | | |
2013
|
| | | | 7% | | | | | | 12.5% | | |
2014 | | | | | 9% | | | | | | 16% | | |
2017 onwards (1)
|
| | | | 7.5% | | | | | | 16% | | |
Underwriters
|
| |
Number of
Shares |
| |||
| | | | | | ||
Total | | | | | | | |
|
| | |
No Exercise
|
| |
Full Exercise
|
| ||||||
Per share
|
| | | $ | | | | | $ | | | ||
Total
|
| | | $ | | | | | $ | | | |
Itemized expense
|
| |
Amount
|
| |||
SEC registration fee
|
| | | $ | | | |
FINRA filing fee
|
| | |||||
NASDAQ Global Market listing fee
|
| | |||||
Printing and engraving expenses
|
| | |||||
Legal fees and expenses
|
| | |||||
Transfer agent and registrar fees
|
| | |||||
Accounting fees and expenses
|
| | |||||
Miscellaneous
|
| | | | | | |
Total
|
| | | $ | | | |
|
| | |
Page
|
|
| | | ||
FINANCIAL STATEMENTS: | | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | |
| Tel-Aviv, Israel | | | /s/ Kesselman & Kesselman | |
| March 30, 2017 | | | Certified Public Accountants (Isr.) | |
| | | | A member firm of PricewaterhouseCoopers International Limited | |
| | |
December 31
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
Assets
|
| | | ||||||||||
CURRENT ASSETS: | | | | ||||||||||
Cash and cash equivalents
|
| | | $ | 5,895 | | | | | $ | 7,001 | | |
Prepaid expenses and other current assets
|
| | | | 244 | | | | | | 472 | | |
Advance payment
|
| | | | — | | | | | | 823 | | |
TOTAL CURRENT ASSETS | | | |
|
6,139
|
| | | |
|
8,296
|
| |
NON-CURRENT ASSETS: | | | | ||||||||||
Advance payment
|
| | | | 625 | | | | | | — | | |
Long term receivables
|
| | | | — | | | | | | 1,190 | | |
Restricted long term deposits
|
| | | | 92 | | | | | | 107 | | |
Property and equipment, net
|
| | | | 785 | | | | | | 798 | | |
Funds in respect of employee rights upon retirement
|
| | | | 603 | | | | | | 594 | | |
TOTAL NON-CURRENT ASSETS | | | |
|
2,105
|
| | | |
|
2,689
|
| |
TOTAL ASSETS
|
| | | $ | 8,244 | | | | | $ | 10,985 | | |
Liabilities net of capital deficiency
|
| | | ||||||||||
CURRENT LIABILITIES: | | | | ||||||||||
Accounts payable
|
| | | $ | 311 | | | | | $ | 667 | | |
Accrued expenses and other
|
| | | | 1,487 | | | | | | 3,623 | | |
Loans from the controlling shareholder
|
| | | | 17,338 | | | | | | 37,338 | | |
TOTAL CURRENT LIABILITIES | | | |
|
19,136
|
| | | |
|
41,628
|
| |
LONG-TERM LIABILITIES – | | | | ||||||||||
Liability for employee rights upon retirement
|
| | | | 626 | | | | | | 694 | | |
TOTAL LONG-TERM LIABILITIES
|
| | | | 626 | | | | | | 694 | | |
COMMITMENTS
|
| | | | | | | | | | | | |
TOTAL LIABILITIES
|
| | | $ | 19,762 | | | | | $ | 42,322 | | |
CAPITAL DEFICIENCY: | | | | ||||||||||
Ordinary shares, NIS 0.1 par value – authorized: 8,775,783 as of
December 31, 2015 and 2016; issued and outstanding: 3,494,579 as of December 31, 2015 and 2016 |
| | | | 82 | | | | | | 82 | | |
Additional paid-in capital
|
| | | | 31,322 | | | | | | 32,274 | | |
Accumulated deficit
|
| | | | (42,922) | | | | | | (63,693) | | |
TOTAL CAPITAL DEFICIENCY
|
| | | | (11,518) | | | | | | (31,337) | | |
TOTAL LIABILITIES NET OF CAPITAL DEFICIENCY
|
| | | $ | 8,244 | | | | | $ | 10,985 | | |
|
| | |
Year ended December 31,
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
RESEARCH AND DEVELOPMENT EXPENSES
|
| | | $ | 7,184 | | | | | $ | 17,023 | | |
GENERAL AND ADMINISTRATIVE EXPENSES
|
| | | | 2,463 | | | | | | 3,733 | | |
TOTAL OPERATING LOSS
|
| | | | 9,647 | | | | | | 20,756 | | |
FINANCIAL EXPENSES, NET
|
| | | | 13 | | | | | | 15 | | |
LOSS FOR THE YEAR
|
| | | $ | 9,660 | | | | | $ | 20,771 | | |
BASIC AND DILUTED LOSS PER ORDINARY SHARE
|
| | | $ | 2.76 | | | | | $ | 5.94 | | |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
|
| | |
|
3,494,579
|
| | | |
|
3,494,579
|
| |
|
| | |
Ordinary shares
|
| |
Additional
paid-in capital |
| |
Accumulated
deficit |
| |
Total
|
| ||||||||||||||||||
| | |
Number
of shares |
| |
Amounts
|
| |
Amounts
|
| |||||||||||||||||||||
BALANCE AS OF JANUARY 1, 2015
|
| | | | 3,494,579 | | | | | $ | 82 | | | | | $ | 30,193 | | | | | $ | (33,262) | | | | | $ | (2,987) | | |
CHANGES DURING 2015: | | | | | | | |||||||||||||||||||||||||
Loss for the year
|
| | | | | | | | | | | | | | | | | | | | | | (9,660) | | | | | | (9,660) | | |
Share-based compensation
|
| | | | | | | | | | | | | | | | 1,129 | | | | | | | | | | | | 1,129 | | |
BALANCE AS OF DECEMBER 31, 2015
|
| | | | 3,494,579 | | | | | | 82 | | | | | | 31,322 | | | | | | (42,922) | | | | | | (11,518) | | |
CHANGES DURING 2016: | | | | | | | |||||||||||||||||||||||||
Loss for the year
|
| | | | | | | | | | | | | | | | | | | | | | (20,771) | | | | | | (20,771) | | |
Share-based compensation
|
| | | | | | | | | | | | | | | | 952 | | | | | | | | | | | | 952 | | |
BALANCE AS OF DECEMBER 31, 2016
|
| | | | 3,494,579 | | | | | $ | 82 | | | | | | 32,274 | | | | | $ | (63,693) | | | | | $ | (31,337) | | |
|
| | |
Year ended December 31
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | | | | ||||||||||
Loss
|
| | | $ | (9,660) | | | | | $ | (20,771) | | |
Adjustments required to reconcile loss to net cash used in operating activities:
|
| | | ||||||||||
Depreciation
|
| | | | 300 | | | | | | 359 | | |
Changes in accrued liability for employee rights upon retirement
|
| | | | (86) | | | | | | 68 | | |
Share-based compensation
|
| | | | 1,129 | | | | | | 952 | | |
In-process research and development acquired
|
| | | | 431 | | | | | | — | | |
Finance expenses, net
|
| | | | 17 | | | | | | 8 | | |
Changes in operating asset and liabilities:
|
| | | ||||||||||
Prepaid expenses and other current assets
|
| | | | 1 | | | | | | (228) | | |
Accounts payable, accrued expenses and other
|
| | | | 449 | | | | | | 2,505 | | |
Advance payment
|
| | | | (625) | | | | | | (198) | | |
Long term receivables
|
| | | | — | | | | | | (1,190) | | |
Net cash used in operating activities
|
| | | | (8,044) | | | | | | (18,495) | | |
CASH FLOWS FROM INVESTING ACTIVITIES: | | | | ||||||||||
Purchase of property and equipment
|
| | | | (291) | | | | | | (385) | | |
Long term deposits
|
| | | | (8) | | | | | | (15) | | |
Amounts funded in respect of employee rights upon retirement,
net |
| | | | 89 | | | | | | 9 | | |
Net cash used in investing activities
|
| | | | (210) | | | | | | (391) | | |
CASH FLOWS FROM FINANCING ACTIVITIES: | | | | ||||||||||
Loans received from the controlling shareholder
|
| | | | 13,572 | | | | | | 20,000 | | |
Net cash provided by financing activities
|
| | | | 13,572 | | | | | | 20,000 | | |
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS
|
| | |
|
(17)
|
| | | |
|
(8)
|
| |
INCREASE IN CASH AND CASH EQUIVALENTS
|
| | | | 5,301 | | | | | | 1,106 | | |
CASH AND CASH EQUIVALENTS AT BEGINNING OF THE YEAR
|
| | |
|
594
|
| | | |
|
5,895
|
| |
CASH AND CASH EQUIVALENTS AT END OF THE YEAR
|
| | | $ | 5,895 | | | | | $ | 7,001 | | |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
|
| | | ||||||||||
Purchase of property and equipment
|
| | | $ | 23 | | | | | $ | 10 | | |
Acquisition of in-process research and development product candidate
|
| | | $ | 431 | | | | | $ | — | | |
|
| | |
%
|
|
Laboratory equipment | | |
10 – 33 (mainly 15 – 25)
|
|
Office equipment and furniture | | |
7 – 15
|
|
Computers and related equipment | | |
33
|
|
| | |
December 31
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
Cost: | | | | ||||||||||
Laboratory equipment
|
| | | $ | 1,065 | | | | | $ | 1,263 | | |
Office equipment and furniture
|
| | | | 182 | | | | | | 234 | | |
Computers and software
|
| | | | 222 | | | | | | 282 | | |
Leasehold improvements
|
| | | | 466 | | | | | | 528 | | |
| | | | | 1,935 | | | | | | 2,307 | | |
Less: | | | | ||||||||||
Accumulated depreciation and amortization
|
| | | | (1,150) | | | | | | (1,509) | | |
Property and equipment, net
|
| | | $ | 785 | | | | | $ | 798 | | |
|
Year
|
| |
Amount
|
| |||
2017
|
| | | $ | 419 | | |
2018
|
| | | | 429 | | |
2019
|
| | | | 429 | | |
2020
|
| | | | 429 | | |
Total
|
| | | $ | 1,706 | | |
| | |
2015
|
| |
2016
|
|
Value of one ordinary share
|
| |
$11.35
|
| |
$21.59
|
|
Dividend yield
|
| |
0%
|
| |
0%
|
|
Expected volatility
|
| |
62.46% – 66.22%
|
| |
68.46% – 79.1%
|
|
Risk-free interest rate
|
| |
1.61% – 1.81%
|
| |
0.95% – 1.34%
|
|
Expected term
|
| |
5.5 – 7.5 years
|
| |
5 – 6.71 years
|
|
|
| | |
Year ended December 31
|
| |||||||||||||||||||||||||||||||||
| | |
2015
|
| |
2016
|
| ||||||||||||||||||||||||||||||
| | |
Number of
options |
| |
Weighted
average exercise price |
| |
Weighted
average remaining contractual life |
| |
Number of
options |
| |
Weighted
average exercise price |
| |
Weighted
average remaining contractual life |
| ||||||||||||||||||
Options outstanding at the beginning of the year
|
| | | | — | | | | | | — | | | | | | — | | | | | | 173,440 | | | | | $ | 2.86 | | | | | | 9.25 | | |
Granted
|
| | | | 173,440 | | | | | $ | 2.86 | | | | | | 9.25 | | | | | | 50,422 | | | | | $ | 2.86 | | | | | | 9.59 | | |
Options outstanding at the end
of the year |
| | | | 173,440 | | | | | $ | 2.86 | | | | | | 9.25 | | | | | | 223,862 | | | | | $ | 2.86 | | | | | | 8.55 | | |
Options exercisable at the end of the year
|
| | | | 54,200 | | | | | $ | 2.86 | | | | | | 9.25 | | | | | | 106,854 | | | | | $ | 2.86 | | | | | | 9.59 | | |
|
| | |
Year ended
December 31 |
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
Research and development expenses
|
| | | $ | 468 | | | | | $ | 541 | | |
General and administrative expenses
|
| | | | 661 | | | | | | 411 | | |
| | | | $ | 1,129 | | | | | $ | 952 | | |
|
| | |
As of December 31
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
In respect of: | | | | ||||||||||
Net operating loss carry forward
|
| | | $ | 9,468 | | | | | $ | 10,912 | | |
Research and development expenses
|
| | | | 1,377 | | | | | | 2,935 | | |
Other
|
| | | | 43 | | | | | | 152 | | |
Less – valuation allowance
|
| | | | (10,888) | | | | | | (13,999) | | |
Net deferred tax assets
|
| | | $ | — | | | | | $ | — | | |
|
Exhibit No.
|
| |
Description
|
|
1.1* | | | Form of Underwriting Agreement. | |
3.1** | | | Articles of Association of the Registrant (currently in effect). | |
3.2* | | | Form of Amended and Restated Articles of Association of the Registrant to become effective upon closing of this offering. | |
4.1* | | | Form of Specimen Share Certificate. | |
5.1* | | | Form of Opinion of Gross, Kleinhendler, Hodak, Halevy, Greenberg & Co., Israeli counsel to the Registrant, as to the validity of the ordinary shares. | |
10.1** | | | 2014 Share Incentive Plan. | |
10.2* | | | Form of Registration Rights Agreement. | |
10.3**∞ | | | Project Transfer Agreement by and between the Registrant and with M. Arkin (1999) Ltd. dated as of December 31, 2015. | |
10.4*+ | | | Innovative Product Development and Contract Manufacturing Agreement between M . Arkin (1999) Ltd. and Perrigo Israel Pharmaceuticals Ltd., dated as of January 23, 2012. | |
10.5*+ | | | Development, Manufacturing and Commercialization Agreement between Perrigo UK Finco Limited Partnership and Sol-Gel Technologies Ltd., dated as of April 27, 2015. | |
10.6*+ | | | Amendment to the Development, Manufacturing and Commercialization Agreement between the Registrant and Perrigo UK Finco Limited Partnership, dated as of October 26, 2015. | |
10.7*+ | | | Development, Manufacturing and Commercialization Agreement between the Registrant and Perrigo UK Finco Limited Partnership, dated as of June 19, 2016. | |
10.8* | | | Form of Indemnification Agreement. | |
10.9* | | | Compensation Policy. | |
10.10∞ | | | Lease Agreement by and between the Registrant and Rachel Zacks, dated as of October 10, 2007. | |
10.11∞ | | | Lease Agreement by and between the Registrant and Rachel Zacks, dated as of September 29, 2014. | |
Exhibit No.
|
| |
Description
|
|
10.12∞ | | | Lease Agreement by and between the Registrant and Rachel Zacks, dated as of March 30, 2016. | |
10.13∞ | | | Lease Agreement by and between the Registrant and Rachel Zacks, dated as of September 20, 2016. | |
10.14∞ | | | Lease Agreement by and between the Registrant and Rachel Zacks, dated as of January 30, 2017. | |
10.15** | | | Promissory Note by and between the Registrant and Moshe Arkin, dated as of August 2, 2016. | |
10.16** | | | Schedule A, as amended, of Promissory Note by and between the Registrant and Moshe Arkin, dated as of December 21, 2016. | |
10.17 | | | Assignment Agreement between the Registrant and Medicis Pharmaceutical Corporation, dated October 9, 2011. | |
21.1** | | | List of subsidiaries of the Registrant. | |
23.1* | | | Consent of Kesselman and Kesselman, Member Firm of PricewaterhouseCoopers International Limited. | |
23.2* | | | Consent of Gross, Kleinhendler, Hodak, Halevy, Greenberg & Co., Israeli counsel to the Registrant (included in Exhibit 5.1). | |
24.1** | | | Power of Attorney (included in the signature page of the Registration Statement). | |
99.1** | | | Consent of director nominee. | |
99.2** | | | Consent of director nominee. | |
99.3** | | | Consent of director nominee. | |
| | | | Sol-Gel Technologies Ltd. | | |||
| | | | By: | | | | |
| | | | | | | Name: Alon Seri-Levy | |
| | | | | | | Title: Chief Executive Officer | |
Signatures
|
| |
Title
|
| |
Date
|
|
Alon Seri-Levy
|
| | Chief Executive Officer | | | , 2017 | |
Gilad Mamlok
|
| | Chief Financial Officer | | | , 2017 | |
Moshe Arkin
|
| | Director | | | , 2017 | |
| | | | By: | | |||
| | | | By: | | | | |
| | | | | | | Name: | |
| | | | | | | Title: | |
Exhibit 10.17
ASSIGNMENT
WHEREAS: MEDICIS PHARMACEUTICAL CORPORATION, a corporation organized under the laws of Delaware (hereinafter ASSIGNOR), is an owner of certain patent rights pursuant to that certain Development and License Agreement between ASSIGNOR and ASSIGNEE (defined below), dated October 9, 2011 (hereinafter AGREEMENT); and
WHEREAS: ASSIGNOR desires to assign to SOL-GEL TECHNOLOGIES LTD., a corporation organized under the laws of the Country of Israel (hereinafter ASSIGNEE) ASSIGNOR'S entire interest in and to a US patent application # 13/537,646, titled: "Stabilized Topical Formulations Containing Core-Shell Microcapsules" (the "PATENT").
NOW, THEREFORE, for good and valuable consideration provided by ASSIGNEE to ASSIGNOR, the receipt of which is hereby acknowledged, ASSIGNOR hereby sells, assigns and transfers to ASSIGNEE, its successors, legal representatives, or assigns, ASSIGNOR'S full and exclusive rights, titles and interests to the PATENT, and to any additional legal protections to be obtained for said PATENT or any continuations, continuations-in-part, divisions, renewals, extensions, substitutions, replacements, or reissues thereof, and every priority right that is or may be predicated upon or arise from the PATENT, or any legal equivalent of any thereof in any country for the full term or terms for which the same may be granted.
SAID ASSIGNOR hereby further covenants that ASSIGNOR has full right to convey the entire right, title, and interest herein sold, assigned, transferred, and set over herein.
AND SAID ASSIGNOR further covenants that ASSIGNOR will, at any time, when reasonably called upon to do so by the ASSIGNEE, its successors, legal representatives, or assigns, at ASSIGNEE'S cost and expense, communicate thereto any facts known to him relating to said PATENT; execute and deliver any and all lawful papers (including, but not limited to, granting powers of attorney and executing inventor declarations for continuations-in-part and reissues of patent applications hereby assigned); make all rightful oaths, affidavits, or declarations; testify in any legal proceedings, mediations, arbitrations, or other proceedings; and perform all other reasonable lawful acts that may be deemed by ASSIGNEE necessary or desirable to obtain, secure, and/or vest the benefit of the rights herein assigned, and perfect the title to said PATENT and all related rights thereto in the name of and for the benefit for the ASSIGNEE, its successors, legal representatives, or assigns, and to assist or enable the ASSIGNEE, its successors, legal representatives, or assigns to enforce, protect, or otherwise benefit from the rights in said, applications and patents hereby granted.
ASSIGNEE hereby grants to ASSIGNOR and ASSIGNOR'S affiliates a non-exclusive, transferable, sub-licensable, royalty-free, perpetual, license to practice those inventions claimed under the PATENT.
This ASSIGNMENT shall be binding upon ASSIGNOR'S heirs, executors, administrators, successors, and/or assigns.
Date: 8/16/13 | /s/ |
MEDICIS PHARMACEUTICAL CORPORATION |
I hereby accept the above assignment for and on behalf/of the ASSIGNEE
Date: August 8, 2013 | /s/ Alon Seri-Levy |
SOL-GEL TECHNOLOGIES LTD. |
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