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State of Israel
|
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2834
|
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Not Applicable
|
|
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(State or Other Jurisdiction of
Incorporation or Organization) |
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(Primary Standard Industrial
Classification Code Number) |
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(I.R.S. Employer Identification No.)
|
|
|
Joshua G. Kiernan
Nathan Ajiashvili Latham & Watkins LLP 885 Third Avenue New York, NY 10022 Tel: +1 212 906 1200 Fax: +1 212 751 4864 |
| |
Gene Kleinhendler
Perry Wildes Gross, Kleinhendler, Hodak, Halevy, Greenberg & Co. One Azrieli Center Tel Aviv 670201, Israel Tel: +972 3 607 4444 Fax: +972 3 607 4470 |
| |
Eric W. Blanchard
Brian K. Rosenzweig Matthew T. Gehl Covington & Burling LLP The New York Times Building 620 Eighth Avenue New York, NY 10018-1405 Tel: +1 212 841 1000 Fax: +1 212 841 1010 |
| |
Chaim Friedland
Ari Fried Gornitzky & Co. Zion House 45 Rothschild Blvd. Tel Aviv 6578403, Israel Tel: +972 3 710 9191 Fax: +972 3 560 6555 |
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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
|
| | | $ | 86,250,000 | | | | | $ | 9,996 | | |
|
| | |
Per
share |
| |
Total
|
| ||||||
Initial public offering price
|
| | | $ | | | | | $ | | | ||
Underwriting discounts and commission (1)
|
| | | $ | | | | | | $ | | | |
Proceeds to us (before expenses)
|
| | | $ | | | | | | $ | | | |
| Jefferies | | |
BMO Capital Markets
|
|
| JMP Securities | | |
Raymond James
|
|
| | | | | 1 | | | |
| | | | | 12 | | | |
| | | | | 57 | | | |
| | | | | 58 | | | |
| | | | | 59 | | | |
| | | | | 60 | | | |
| | | | | 61 | | | |
| | | | | 62 | | | |
| | | | | 63 | | | |
| | | | | 65 | | | |
| | | | | 66 | | | |
| | | | | 80 | | | |
| | | | | 116 | | | |
| | | | | 138 | | | |
| | | | | 140 | | | |
| | | | | 142 | | | |
| | | | | 150 | | | |
| | | | | 153 | | | |
| | | | | 165 | | | |
| | | | | 174 | | | |
| | | | | 175 | | | |
| | | | | 175 | | | |
| | | | | 175 | | | |
| | | | | 177 | | | |
| | | | | F-1 | | |
| | |
Year Ended December 31,
|
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Six Months Ended June 30,
|
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| | |
2015
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2016
|
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2016
|
| |
2017
|
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| | | | | | | | | | | | | | |
(Unaudited)
|
| |||||||||
| | |
(in thousands, except share and per share data )
|
| |||||||||||||||||||||
Statement of Operations Data: | | | | | | | | | | | | | | | | ||||||||||
Research and development expenses
|
| | | $ | 7,184 | | | | | $ | 17,023 | | | | | $ | 6,797 | | | | | $ | 9,376 | | |
General and administrative expenses
|
| | | | 2,463 | | | | | | 3,733 | | | | | | 1,721 | | | | | | 2,460 | | |
Total operating loss
|
| | | | 9,647 | | | | | | 20,756 | | | | | | 8,518 | | | | | | 11,836 | | |
Financial expenses, net
|
| | | | 13 | | | | | | 15 | | | | | | (7) | | | | | | (4) | | |
Loss for the year
|
| | | $ | 9,660 | | | | | $ | 20,771 | | | | | $ | 8,511 | | | | | $ | 11,832 | | |
Basic and diluted loss per ordinary share (1)
|
| | | $ | 2.76 | | | | | $ | 5.94 | | | | | $ | 2.44 | | | | | $ | 3.39 | | |
Weighted average number of ordinary shares outstanding – basic and diluted
|
| | | | 3,494,579 | | | | | | 3,494,579 | | | | | | 3,494,579 | | | | | | 3,494,579 | | |
Pro forma basic and diluted net loss per ordinary share (unaudited) (1)(2)
|
| | | | | | | | | $ | | | | | | | | | | | | $ | | | |
Pro forma weighted average number of ordinary shares outstanding – basic and diluted (unaudited) (2)
|
| | | | | | | | | | | | | | | | | | | | | | | | |
|
| | |
June 30, 2017
|
| |||||||||||||||
| | |
Actual
|
| |
Pro Forma (1)
|
| |
Pro Forma As
Adjusted (2) |
| |||||||||
| | |
(Unaudited, in thousands)
|
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Balance Sheet Data: | | | | | |||||||||||||||
Cash and cash equivalents
|
| | | $ | 23,295 | | | | | $ | | | | | $ | | | ||
Total assets
|
| | | | 28,702 | | | | | | | | | | | | | | |
Total liabilities
|
| | | | 71,485 | | | | | | | | | | | | | | |
Accumulated deficit
|
| | | | (75,525) | | | | | | | | | | | | | | |
Total shareholders’ equity (capital deficiency)
|
| | | | (42,783) | | | | | | | | | | | | | | |
| | |
As of June 30, 2017
|
| |||||||||||||||
| | |
Actual
|
| |
Pro Forma
|
| |
Pro Forma
As Adjusted |
| |||||||||
| | |
(Unaudited)
(in thousands, except share and per share data) |
| |||||||||||||||
Cash and cash equivalents
|
| | | $ | 23,295 | | | | | $ | | | | | $ | | | | |
Loans from the controlling shareholder
|
| | | $ | 65,338 | | | | | $ | | | | | | $ | | | |
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, pro forma; shares authorized and issued and outstanding, pro forma as adjusted |
| | | | 82 | | | | | | | | | | | | | | |
Additional paid-in capital
|
| | | | 32,660 | | | | | | | | | | | | | | |
Accumulated deficit
|
| | | | (75,525) | | | | | | | | | | | | | | |
Total shareholders’ equity (capital deficiency)
|
| | | | (42,783) | | | | | | | | | | | | | | |
Total capitalization
|
| | | $ | 22,555 | | | | | $ | | | | | | $ | | | |
|
|
Assumed initial public offering price per ordinary share
|
| | | | | | | | | $ | | | |
|
Historical net tangible book value (deficit) per ordinary share as of June 30, 2017
|
| | | | ( ) | | | | | | | | |
|
Increase per ordinary share attributable to the conversion of promissory
note as of June 30, 2017 |
| | | | | | | | |||||
|
Pro forma net tangible book value per ordinary share
|
| | | | | | | | | | | | |
|
Increase in pro forma net tangible book value per ordinary share attributable to the offering
|
| | | | | | | | | | | | |
|
Pro forma 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,
|
| |
Six Months Ended June 30,
|
| ||||||||||||||||||
| | |
2015
|
| |
2016
|
| |
2016
|
| |
2017
|
| ||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
| |||||||||
| | |
(in thousands,
except share and per share data) |
| |||||||||||||||||||||
Statement of Operations Data: | | | | | | ||||||||||||||||||||
Research and development expenses
|
| | | $ | 7,184 | | | | | $ | 17,023 | | | | | $ | 6,797 | | | | | $ | 9,376 | | |
General and administrative expenses
|
| | | | 2,463 | | | | | | 3,733 | | | | | | 1,721 | | | | | | 2,460 | | |
Total operating loss
|
| | | | 9,647 | | | | | | 20,756 | | | | | | 8,518 | | | | | | 11,836 | | |
Financial expenses, net
|
| | | | 13 | | | | | | 15 | | | | | | (7) | | | | | | (4) | | |
Loss for the year
|
| | | $ | 9,660 | | | | | $ | 20,771 | | | | | $ | 8,511 | | | | | $ | 11,832 | | |
Basic and diluted loss per ordinary share (1)
|
| | | $ | 2.76 | | | | | $ | 5,94 | | | | | $ | 2.44 | | | | | $ | 3.39 | | |
Weighted average number of ordinary shares
outstanding – basic and diluted |
| | | | 3,494,579 | | | | | | 3,494,579 | | | | | | 3,494,579 | | | | | | 3,494,579 | | |
|
| | |
As of
|
| |||||||||
| | |
December 31,
2016 |
| |
June 30,
2017 |
| ||||||
| | | | | | | | |
(Unaudited)
|
| |||
Balance Sheet Data: | | | | ||||||||||
Cash and cash equivalents
|
| | | $ | 7,001 | | | | | $ | 23,295 | | |
Total assets
|
| | | | 10,985 | | | | | | 28,702 | | |
Total liabilities
|
| | | | 42,322 | | | | | | 71,485 | | |
Accumulated deficit
|
| | | | (63,693) | | | | | | (75,525) | | |
Total capital deficiency
|
| | | | (31,337) | | | | | | (42,783) | | |
| | |
For the Year Ended
December 31, |
| |
For the Six Months Ended
June 30, |
| ||||||||||||||||||
| | |
2015
|
| |
2016
|
| |
2016
|
| |
2017
|
| ||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
| |||||||||
| | |
(in thousands)
|
| |||||||||||||||||||||
Research and development expenses
|
| | | $ | 7,184 | | | | | $ | 17,023 | | | | | $ | 6,797 | | | | | $ | 9,376 | | |
General and administrative expenses
|
| | | | 2,463 | | | | | | 3,733 | | | | | | 1,721 | | | | | | 2,460 | | |
Total operating loss
|
| | | | 9,647 | | | | | | 20,756 | | | | | | 8,518 | | | | | | 11,836 | | |
Financial expenses (income), net
|
| | | | 13 | | | | | | 15 | | | | | | (7) | | | | | | (4) | | |
Loss for the period
|
| | | $ | 9,660 | | | | | $ | 20,771 | | | | | $ | 8,511 | | | | | $ | 11,832 | | |
|
| | |
Six Months Ended June 30,
|
| |||||||||
| | |
2016
|
| |
2017
|
| ||||||
| | |
(Unaudited)
|
| |||||||||
| | |
(in thousands)
|
| |||||||||
Payroll and related expenses
|
| | | $ | 1,900 | | | | | $ | 2,412 | | |
Clinical trial expenses
|
| | | | 2,387 | | | | | | 4,093 | | |
Professional consulting and subcontracted work
|
| | | | 1,813 | | | | | | 1,809 | | |
Other
|
| | | | 697 | | | | | | 1,062 | | |
Total research and development expenses
|
| | | $ | 6,797 | | | | | $ | 9,376 | | |
|
| | |
Year Ended December 31,
|
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
| | |
(in thousands)
|
| |||||||||
Payroll and related expenses
|
| | | $ | 2,647 | | | | | $ | 3,629 | | |
Clinical trial 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, |
| |
Six Months
Ended June 30, |
| ||||||||||||||||||
| | |
2015
|
| |
2016
|
| |
2016
|
| |
2017
|
| ||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
| |||||||||
| | |
(in thousands)
|
| |||||||||||||||||||||
Net cash used in operating activities
|
| | | $ | (8,044) | | | | | $ | (18,495) | | | | | $ | (7,392) | | | | | $ | (11,143) | | |
Net cash used in investing activities
|
| | | | (210) | | | | | | (391) | | | | | | (153) | | | | | | (603) | | |
Net cash from financing activities
|
| | | | 13,572 | | | | | | 20,000 | | | | | | 5,000 | | | | | | 28,000 | | |
Increase (decrease) in cash and cash equivalents
|
| | | $ | 5,301 | | | | | $ | 1,106 | | | | | $ | (2,545) | | | | | $ | 16,254 | | |
|
| | |
Total
|
| |
Less than
1 year |
| |
1 – 3 years
|
| |
3 – 5 years
|
| |
More than
5 years |
| |||||||||||||||
| | |
(in thousands)
|
| |||||||||||||||||||||||||||
Operating lease obligations (1)
|
| | | $ | 1,706 | | | | | $ | 419 | | | | | $ | 1,287 | | | | | $ | — | | | | | $ | — | | |
Total
|
| | | $ | 1,706 | | | | | $ | 419 | | | | | $ | 1,287 | | | | | $ | — | | | | | $ | — | | |
|
| | |
For the Year Ended December 31,
|
| |
For the
Six Months Ended June 30, |
| |||
| |
2015
|
| |
2016
|
| |
2017
|
| |
Value of one ordinary share
|
| |
$11.35
|
| |
$21.59
|
| |
$36.84
|
|
Dividend yield
|
| |
0%
|
| |
0%
|
| |
0%
|
|
Expected volatility
|
| |
62.46% – 66.22%
|
| |
68.45% – 79.1%
|
| |
73.74% – 78.71%
|
|
Risk-free interest rate
|
| |
1.61% – 1.81%
|
| |
0.95% – 1.34%
|
| |
1.57% – 2.23%
|
|
Expected term
|
| |
5.5 – 7.5 years
|
| |
5 – 6.71 years
|
| |
5.47 – 6.97 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 | | | | | $ | 36.84 | | |
July 13, 2017
|
| | | | 15,040 | | | | | | Ordinary | | | | | | options | | | | | $ | 2.86 | | | | | | * | | |
July 13, 2017
|
| | | | 211,470 | | | | | | Ordinary | | | | | | options | | | | | $ | 10.02 | | | | | | * | | |
August 22, 2017
|
| | | | 70,500 | | | | | | Ordinary | | | | | | options | | | | | $ | 10.02 | | | | | | * | | |
VERED Phase II Efficacy Results at Week 12 (ITT)
|
| |
Vehicle
(N=30) |
| |
VERED 1%
(N=32) |
| |
VERED 5%
(N=30) |
|
Dichotomized IGA – Primary Success | | | | | ||||||
Success
|
| |
6 (20.0%)
|
| |
12 (37.5%)
|
| |
16 (53.3%)
|
|
Failure
|
| |
24 (80.0%)
|
| |
20 (62.5%)
|
| |
14 (46.7%)
|
|
p-value relative to vehicle
|
| | | | |
0.0836
|
| |
0.0013
|
|
Inflammatory Lesion Count – Change from Baseline | | | | | ||||||
Mean
|
| |
-7.4
|
| |
-21.6
|
| |
-14.1
|
|
Median
|
| |
-10.0
|
| |
-12.5
|
| |
-15.0
|
|
p-value relative to vehicle
|
| | | | |
0.0276
|
| |
0.0037
|
|
LOCF (last observation carried forward) used to impute mission observations
|
| | | | |
0.0836
|
| |
0.0013
|
|
Area of Activity
|
| |
As of
June 30, 2017 |
| |||
Administrative
|
| | | | 6 | | |
Research, development and quality assurance
|
| | | | 44 | | |
Total
|
| | | | 50 | | |
|