|
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 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 |
|
| | |
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 | | | |
| | | | | 64 | | | |
| | | | | 66 | | | |
| | | | | 68 | | | |
| | | | | 83 | | | |
| | | | | 120 | | | |
| | | | | 142 | | | |
| | | | | 144 | | | |
| | | | | 146 | | | |
| | | | | 154 | | | |
| | | | | 157 | | | |
| | | | | 169 | | | |
| | | | | 178 | | | |
| | | | | 179 | | | |
| | | | | 179 | | | |
| | | | | 179 | | | |
| | | | | 180 | | | |
| | | | | F-1 | | |
| | |
Year Ended December 31,
|
| |
Nine Months Ended September 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 | | | | | $ | 13,097 | | | | | $ | 21,389 | | |
General and administrative expenses
|
| | | | 2,463 | | | | | | 3,733 | | | | | | 2,809 | | | | | | 4,781 | | |
Total operating loss
|
| | | | 9,647 | | | | | | 20,756 | | | | | | 15,906 | | | | | | 26,170 | | |
Financial expenses, net
|
| | | | 13 | | | | | | 15 | | | | | | (1) | | | | | | (52) | | |
Loss for the year
|
| | | $ | 9,660 | | | | | $ | 20,771 | | | | | $ | 15,905 | | | | | $ | 26,118 | | |
Basic and diluted loss per ordinary share (1)
|
| | | $ | 1.53 | | | | | $ | 3.30 | | | | | $ | 2.53 | | | | | $ | 4.15 | | |
Weighted average number of ordinary shares outstanding – basic and diluted
|
| | | | 6,290,242 | | | | | | 6,290,242 | | | | | | 6,290,242 | | | | | | 6,290,244 | | |
Pro forma basic and diluted net loss per ordinary share (unaudited) (1)(2)
|
| | | | | | | | | $ | 1.77 | | | | | | | | | | | $ | 2.23 | | |
Pro forma weighted average number of ordinary shares outstanding – basic and diluted (unaudited) (2)
|
| | | | | | | | | | 11,735,067 | | | | | | | | | | | | 11,735,069 | | |
|
| | |
September 30, 2017
|
| |||||||||||||||
| | |
Actual
|
| |
Pro Forma (1)
|
| |
Pro Forma As
Adjusted (2) |
| |||||||||
| | |
(Unaudited, in thousands)
|
| |||||||||||||||
Balance Sheet Data: | | | | | |||||||||||||||
Cash and cash equivalents
|
| | | $ | 12,491 | | | | | $ | 12,491 | | | | | $ | 66,491 | | |
Total assets
|
| | | | 22,782 | | | | | | 22,782 | | | | | | 76,782 | | |
Total liabilities
|
| | | | 71,767 | | | | | | 6,429 | | | | | | 6,429 | | |
Accumulated deficit
|
| | | | (89,811) | | | | | | (89,811) | | | | | | (89,811) | | |
Total shareholders’ equity (capital deficiency)
|
| | | | (48,985) | | | | | | 16,353 | | | | | | 70,353 | | |
| | |
As of September 30, 2017
|
| |||||||||||||||
| | |
Actual
|
| |
Pro Forma
|
| |
Pro Forma
As Adjusted |
| |||||||||
| | |
(Unaudited)
(in thousands, except share and per share data) |
| |||||||||||||||
Cash and cash equivalents
|
| | | $ | 12,491 | | | | | $ | 12,491 | | | | | $ | 66,491 | | |
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 6,290,244 shares issued and outstanding, actual; 50,000,000 shares authorized and 11,735,069 issued and outstanding, pro forma; 50,000,000 shares authorized and 16,735,069 issued and outstanding, pro forma as adjusted
|
| | | | 148 | | | | | | 275 | | | | | | 393 | | |
Additional paid-in capital
|
| | | | 40,678 | | | | | | 105,889 | | | | | | 159,771 | | |
Accumulated deficit
|
| | | | (89,811) | | | | | | (89,811) | | | | | | (89,811) | | |
Total shareholders’ equity (capital deficiency)
|
| | | | (48,985) | | | | | | 16,353 | | | | | | 70,353 | | |
Total capitalization
|
| | | $ | 16,353 | | | | | $ | 16,353 | | | | | $ | 70,353 | | |
|
| | | |
Assumed initial public offering price per ordinary share
|
| | | | | | | | | $ | 12.00 | | |
| | | |
Historical net tangible book value (deficit) per ordinary share as of September 30, 2017
|
| | | | (7.79) | | | | | | | | |
| | | |
Increase per ordinary share attributable to the conversion of promissory note as of September 30, 2017
|
| | | | 9.18 | | | | |||||
| | | |
Pro forma net tangible book value per ordinary share
|
| | | | 1.39 | | | | | | | | |
| | | |
Increase in pro forma net tangible book value per ordinary share attributable to the offering
|
| | | | 2.81 | | | | | | | | |
| | | |
Pro forma as adjusted net tangible book value per share after this offering
|
| | | | 4.20 | | | | |||||
| | | |
Dilution per ordinary share to new investors
|
| | | | | | | | | $ | 7.80 | | |
| | | |
Percentage of dilution per ordinary share to new investors
|
| | | | | | | | | | 65% | | |
|
| | |
Shares purchased
|
| |
Total consideration
|
| |
Average
price per share |
| ||||||||||||||||||||||||
| | |
Number
|
| |
%
|
| |
Amount
|
| |
%
|
| | | |||||||||||||||||||
Existing shareholder
|
| | | | 11,735,069 | | | | | | 70.1 | | | | | $ | 95,531,592 | | | | | | 61.4 | | | | | $ | 8.14 | | | | ||
New investors
|
| | | | 5,000,000 | | | | | | 29.9 | | | | | | 60,000,000 | | | | | | 38.6 | | | | | | 12.00 | | | | ||
Total
|
| | | | 16,735,069 | | | | | | 100 | | | | | $ | 155,531,592 | | | | | | 100 | | | | | $ | 9.29 | | | | ||
|
| | |
Year Ended December 31,
|
| |
Nine Months Ended September 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 | | | | | $ | 13,097 | | | | | $ | 21,389 | | |
General and administrative expenses
|
| | | | 2,463 | | | | | | 3,733 | | | | | | 2,809 | | | | | | 4,781 | | |
Total operating loss
|
| | | | 9,647 | | | | | | 20,756 | | | | | | 15,906 | | | | | | 26,170 | | |
Financial expenses, net
|
| | | | 13 | | | | | | 15 | | | | | | (1) | | | | | | (52) | | |
Loss for the year
|
| | | $ | 9,660 | | | | | $ | 20,771 | | | | | $ | 15,905 | | | | | $ | 26,118 | | |
Basic and diluted loss per ordinary share (1)
|
| | | $ | 1.53 | | | | | $ | 3.30 | | | | | $ | 2.53 | | | | | $ | 4.15 | | |
Weighted average number of ordinary shares outstanding – basic and diluted
|
| | | | 6,290,242 | | | | | | 6,290,242 | | | | | | 6,290,242 | | | | | | 6,290,244 | | |
Pro forma basic and diluted net loss per ordinary share (unaudited) (1)(2)
|
| | | | | | | | | $ | 1.77 | | | | | | | | | | | $ | 2.23 | | |
Pro forma weighted average number of ordinary shares outstanding – basic and diluted (unaudited) (2)
|
| | | | | | | | | | 11,735,067 | | | | | | | | | | | | 11,735,069 | | |
|
| | |
As of
|
| |||||||||
| | |
December 31,
2016 |
| |
September 30,
2017 |
| ||||||
| | | | | | | | |
(Unaudited)
|
| |||
| | |
(in thousands)
|
| |||||||||
Balance Sheet Data: | | | | ||||||||||
Cash and cash equivalents
|
| | | $ | 7,001 | | | | | $ | 12,491 | | |
Total assets
|
| | | | 10,985 | | | | | | 22,782 | | |
Total liabilities
|
| | | | 42,322 | | | | | | 71,767 | | |
Accumulated deficit
|
| | | | (63,693) | | | | | | (89,811) | | |
Total capital deficiency
|
| | | | (31,337) | | | | | | (48,985) | | |
| | |
For the Year Ended
December 31, |
| |
For the Nine Months Ended
September 30, |
| ||||||||||||||||||
| | |
2015
|
| |
2016
|
| |
2016
|
| |
2017
|
| ||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
| |||||||||
| | |
(in thousands)
|
| |||||||||||||||||||||
Research and development expenses
|
| | | $ | 7,184 | | | | | $ | 17,023 | | | | | $ | 13,097 | | | | | $ | 21,389 | | |
General and administrative expenses
|
| | | | 2,463 | | | | | | 3,733 | | | | | | 2,809 | | | | | | 4,781 | | |
Total operating loss
|
| | | | 9,647 | | | | | | 20,756 | | | | | | 15,906 | | | | | | 26,170 | | |
Financial expenses (income), net
|
| | | | 13 | | | | | | 15 | | | | | | (1) | | | | | | (52) | | |
Loss for the period
|
| | | $ | 9,660 | | | | | $ | 20,771 | | | | | $ | 15,905 | | | | | $ | 26,118 | | |
|
| | |
Nine Months Ended September 30,
|
| |||||||||
| | |
2016
|
| |
2017
|
| ||||||
| | |
(Unaudited)
|
| |||||||||
| | |
(in thousands)
|
| |||||||||
Payroll and related expenses
|
| | | $ | 2,785 | | | | | $ | 4,194 | | |
Clinical trial expenses
|
| | | | 6,347 | | | | | | 12,106 | | |
Professional consulting and subcontracted work
|
| | | | 2,476 | | | | | | 3,797 | | |
Other
|
| | | | 1,489 | | | | | | 1,292 | | |
Total research and development expenses
|
| | | $ | 13,097 | | | | | $ | 21,389 | | |
|
| | |
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, |
| |
Nine Months
Ended September 30, |
| ||||||||||||||||||
| | |
2015
|
| |
2016
|
| |
2016
|
| |
2017
|
| ||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
| |||||||||
| | |
(in thousands)
|
| |||||||||||||||||||||
Net cash used in operating activities
|
| | | $ | (8,044) | | | | | $ | (18,495) | | | | | $ | (13,350) | | | | | $ | (17,065) | | |
Net cash used in investing activities
|
| | | | (210) | | | | | | (391) | | | | | | (334) | | | | | | (5,495) | | |
Net cash from financing activities
|
| | | | 13,572 | | | | | | 20,000 | | | | | | 10,000 | | | | | | 28,000 | | |
Increase (decrease) in cash and cash equivalents
|
| | | $ | 5,301 | | | | | $ | 1,106 | | | | | $ | (3,625) | | | | | $ | 5,490 | | |
|
| | |
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
Nine Months Ended September 30, |
| |||
| | |
2015
|
| |
2016
|
| |
2017
|
|
Value of one ordinary share
|
| |
$6.31
|
| |
$11.99
|
| |
$24.37
|
|
Dividend yield
|
| |
0%
|
| |
0%
|
| |
0%
|
|
Expected volatility
|
| |
62.46% – 66.22%
|
| |
68.45% – 79.1%
|
| |
72.91% – 76.63%
|
|
Risk-free interest rate
|
| |
1.61% – 1.81%
|
| |
0.95% – 1.34%
|
| |
1.91% – 2.16%
|
|
Expected term
|
| |
5.5 – 7.5 years
|
| |
5 – 6.71 years
|
| |
5 – 10 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
|
| | | | 272,339 | | | | | | Ordinary | | | | | | options | | | | | $ | 1.59 | | | | | $ | 6.31 | | |
April 12, 2015
|
| | | | 39,854 | | | | | | Ordinary | | | | | | options | | | | | $ | 1.59 | | | | | $ | 6.31 | | |
August 2, 2016
|
| | | | 90,760 | | | | | | Ordinary | | | | | | options | | | | | $ | 1.59 | | | | | $ | 11.99 | | |
February 12, 2017
|
| | | | 53,831 | | | | | | Ordinary | | | | | | options | | | | | $ | 1.59 | | | | | $ | 20.47 | | |
July 13, 2017
|
| | | | 27,072 | | | | | | Ordinary | | | | | | options | | | | | $ | 1.59 | | | | | $ | 24.37 | | |
July 13, 2017
|
| | | | 380,646 | | | | | | Ordinary | | | | | | options | | | | | $ | 5.57 | | | | | $ | 24.37 | | |
August 22, 2017
|
| | | | 126,900 | | | | | | Ordinary | | | | | | options | | | | | $ | 5.57 | | | | | $ | 24.37 | | |
October 1, 2017
|
| | | | 1,800 | | | | | | Ordinary | | | | | | options | | | | | $ | 5.57 | | | | | $ | 24.37 | | |
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
|
|