|
Delaware
(State or jurisdiction of incorporation or organization) |
| |
2834
(Primary Standard Industrial Classification Code Number) |
| |
47-1178401
(IRS Employer Identification No.) |
|
|
Barry I. Grossman, Esq.
Benjamin S. Reichel, Esq. Ellenoff Grossman & Schole LLP 1345 Avenue of the Americas New York, New York 10105 Phone: (212) 370-1300 Fax: (212) 370-7889 |
| |
Michael D. Maline, Esq.
Seo Salimi, Esq. Goodwin Procter LLP 620 Eighth Avenue New York, New York 10018 Phone: (212) 813-8800 Fax: (212) 656-1546 |
|
|
Large accelerated filer ☐
|
| |
Accelerated filer ☐
|
| |
Non-accelerated filer ☐
(Do not check if a smaller reporting company) |
| |
Smaller reporting company ☒
Emerging growth company ☒ |
|
Title of Each Class of Securities to Be Registered
|
| |
Proposed Maximum
Aggregate Offering Price (1) |
| |
Amount of
Registration Fee (1) |
| ||||||
Common Stock, par value $0.0001 per share
|
| | | $ | 35,000,000 | | | | | $ | 4,357.50 | | |
| | |
Per Share
|
| |
Total
|
| ||||||
Initial public offering price
|
| | | $ | | | | | $ | | | ||
Underwriting discounts and commissions
(1)
|
| | | $ | | | | | | $ | | | |
Proceeds, before expenses, to us
|
| | | $ | | | | | | $ | | | |
| Ladenburg Thalmann | | |
Roth Capital Partners
|
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| | |
Page
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| | | | 110 | |
| | | | 116 | |
| | | | 119 | |
| | | | 119 | |
| | | | 119 | |
| | | | F-1 |
|
Product Candidate
|
| |
Indication
|
| |
Next Expected Milestones
|
|
|
MicroProst
|
| |
Chronic Angle Closure Glaucoma
|
| |
Phase III IND H2 2018
|
|
|
MicroStat
|
| |
Mydriasis (Pupil Dilation)
|
| |
Phase III IND H2 2018
|
|
|
MicroTears
|
| |
Dry Eye
|
| |
OTC Registration H1 2019
|
|
|
MicroPine
|
| |
Myopia (Near Sightedness)
|
| |
Phase III IND H1 2019
|
|
| | |
Nine Months Ended
September 30, |
| |
Year Ended,
December 31, |
| ||||||||||||||||||
| | |
2017
|
| |
2016
|
| |
2016
|
| |
2015
|
| ||||||||||||
| | |
(unaudited)
|
| | | | | | | | | | | | | |||||||||
Statement of Operations Data: | | | | | | | | | | | | | | | | | | | | | | | | | |
Operating Expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | $ | 2,125,993 | | | | | $ | 1,985,536 | | | | | $ | 2,966,165 | | | | | $ | 2,783,200 | | |
General and administrative
|
| | | | 842,959 | | | | | | 391,945 | | | | | | 568,775 | | | | | | 1,486,401 | | |
Total Operating Expenses
|
| | | | 2,968,952 | | | | | | 2,377,481 | | | | | | 3,534,940 | | | | | | 4,269,601 | | |
Loss from Operations
|
| | | | (2,968,952 ) | | | | | | (2,377,481 ) | | | | | | (3,534,940 ) | | | | | | (4,269,601 ) | | |
Other Income: | | | | | | | | | | | | | | | | | | | | | | | | | |
Interest income
|
| | | | 1,396 | | | | | | 921 | | | | | | 1,497 | | | | | | 2,412 | | |
Total Other Income
|
| | | | 1,396 | | | | | | 921 | | | | | | 1,497 | | | | | | 2,412 | | |
Net Loss
|
| | | $ | (2,967,556 ) | | | | | $ | (2,376,560 ) | | | | | $ | (3,533,443 ) | | | | | $ | (4,267,189 ) | | |
Net Loss Per Share–Basic and Diluted
|
| | | $ | (0.35 ) | | | | | $ | (0.28 ) | | | | | $ | (0.42 ) | | | | | $ | (0.50 ) | | |
Weighted Average Number of Common Shares
Outstanding–Basic and Diluted |
| | | | | ||||||||||||||||||||
Diluted
|
| | | | 8,514,906 | | | | | | 8,500,000 | | | | | | 8,500,000 | | | | | | 8,500,000 | | |
|
| | |
As of
September 30, 2017 |
| |
As of
December 31, |
| ||||||||||||
|
2016
|
| |
2015
|
| ||||||||||||||
| | |
(unaudited)
|
| | | |||||||||||||
Balance Sheet Data: | | | | | | | | | | | | | | | | | | | |
Cash
|
| | | $ | 7,406,034 | | | | | $ | 3,387,288 | | | | | $ | 2,492,611 | | |
Working capital
|
| | | $ | 6,946,806 | | | | | $ | 2,965,889 | | | | | $ | 2,385,621 | | |
Total assets
|
| | | $ | 7,689,230 | | | | | $ | 3,432,815 | | | | | $ | 2,818,319 | | |
Total liabilities
|
| | | $ | 7,003,720 | | | | | $ | 423,734 | | | | | $ | 419,823 | | |
Total stockholders' equity
|
| | | $ | 685,510 | | | | | $ | 3,009,081 | | | | | $ | 2,398,496 | | |
| | |
As of September 30, 2017
|
| |||||||||||||||
(in thousands, except share and per share amounts)
|
| |
Actual
|
| |
Pro Forma
|
| |
Pro Forma
As Adjusted (1) |
| |||||||||
| | | | | | | | |
(unaudited)
|
| |||||||||
Non-Current Liabilities
|
| | | $ | 6,409,651 | | | | | $ | | | | | | $ | | | |
Stockholders’ Equity: | | | | | | | | | | | | | | | | | | | |
Preferred stock, $0.0001 par value, 36,000,000 shares authorized;
|
| | | | | | | | | | | | | | | | | | |
Series A Convertible Preferred Stock, 20,000,000 shares designated, 10,996,614 shares issued and outstanding at September 30, 2017, no shares issued and outstanding pro forma or pro forma as adjusted (unaudited)
|
| | | | 1,100 | | | | | ||||||||||
Series A-2 Convertible Preferred Stock, 5,714,286 shares designated, 2,958,100 shares issued and outstanding at September 30, 2017, no shares issued and outstanding pro forma or pro forma as adjusted (unaudited)
|
| | | | 296 | | | | | ||||||||||
Series B Convertible Preferred Stock, 10,000,000 shares designated, 0 shares issued and outstanding at September 30, 2017, no shares issued and outstanding pro forma or pro forma as adjusted (unaudited)
|
| | | | 0 | | | | | ||||||||||
Common stock; $0.0001 par value; 60,000,000 shares
September, 9,624,488 shares issued and outstanding at September 30, 2017, and shares issued and outstanding pro forma, and shares issued and outstanding pro forma as adjusted (unaudited) |
| | | | 962 | | | | | ||||||||||
Additional paid-in capital
|
| | | | 17,781,907 | | | | | ||||||||||
Accumulated deficit
|
| | | | (17,098,755 ) | | | | | | | | | | |||||
Total Stockholders’ Equity
|
| | | | 685,510 | | | | | | | | | | |||||
Total Capitalization
|
| | | $ | 685,510 | | | | | $ | | | | | | $ | | | |
|
Assumed initial public offering price per share
|
| | | $ | | | |
|
Historical net tangible book value per share as of September 30, 2017
|
| | |||||
|
Pro forma decrease per share attributable to the pro forma transactions and other adjustments described above
|
| | |||||
|
Pro forma net tangible book value per share as of September 30, 2017
|
| | |||||
|
Increase in pro forma net tangible book value per share attributable to new investors in this offering
|
| | |||||
|
Pro forma as adjusted net tangible book value per share immediately after this offering
|
| | |||||
|
Dilution in pro forma net tangible book value per share to new investors in this
offering |
| | | $ | | | |
| | |
Shares Purchased
|
| |
Total Consideration
|
| |
Average Price
Per Share |
| ||||||||||||||||||
| | |
Number
|
| |
Percent
|
| |
Amount
|
| |
Percent
|
| |||||||||||||||
Existing stockholders
|
| | | | | | | % | | | | | $ | | | | | | | % | | | | | $ | | | |
New public investors
|
| | | | | | | | | | | | | | | | | | | | | | | | $ | | | |
Total
|
| | | | | | | 100 % | | | | | $ | | | | | | | 100 % | | | |
| | |
Nine Months Ended
September 30, |
| |
Year Ended,
December 31, |
| ||||||||||||||||||
| | |
2017
|
| |
2016
|
| |
2016
|
| |
2015
|
| ||||||||||||
| | |
(unaudited)
|
| | | |||||||||||||||||||
Statement of Operations Data: | | | | | | ||||||||||||||||||||
Operating Expenses: | | | | | | ||||||||||||||||||||
Research and development
|
| | | $ | 2,125,993 | | | | | $ | 1,985,536 | | | | | $ | 2,966,165 | | | | | $ | 2,783,200 | | |
General and administrative
|
| | | | 842,959 | | | | | | 391,945 | | | | | | 568,775 | | | | | | 1,486,401 | | |
Total Operating Expenses
|
| | | | 2,968,952 | | | | | | 2,377,481 | | | | | | 3,534,940 | | | | | | 4,269,601 | | |
Loss from Operations
|
| | | | (2,968,952 ) | | | | | | (2,377,481 ) | | | | | | (3,534,940 ) | | | | | | (4,269,601 ) | | |
Other Income: | | | | | | ||||||||||||||||||||
Interest income
|
| | | | 1,396 | | | | | | 921 | | | | | | 1,497 | | | | | | 2,412 | | |
Total Other Income
|
| | | | 1,396 | | | | | | 921 | | | | | | 1,497 | | | | | | 2,412 | | |
Net Loss
|
| | | $ | (2,967,556 ) | | | | | $ | (2,376,560 ) | | | | | $ | (3,533,443 ) | | | | | $ | (4,267,189 ) | | |
Net Loss Per Share–Basic and Diluted
|
| | | $ | (0.35 ) | | | | | $ | (0.28 ) | | | | | $ | (0.42 ) | | | | | $ | (0.50 ) | | |
Weighted Average Number of Common Shares
Outstanding–Basic and Diluted |
| | | | | ||||||||||||||||||||
Diluted
|
| | | | 8,514,906 | | | | | | 8,500,000 | | | | | | 8,500,000 | | | | | | 8,500,000 | | |
| | |
As of
September 30, 2017 |
| |
As of
December 31, |
| ||||||||||||
| | |
2016
|
| |
2015
|
| ||||||||||||
| | |
(unaudited)
|
| | | |||||||||||||
Balance Sheet Data: | | | | | |||||||||||||||
Cash
|
| | | $ | 7,406,034 | | | | | $ | 3,387,288 | | | | | $ | 2,492,611 | | |
Working capital
|
| | | $ | 6,946,806 | | | | | $ | 2,965,889 | | | | | $ | 2,385,621 | | |
Total assets
|
| | | $ | 7,689,230 | | | | | $ | 3,432,815 | | | | | $ | 2,818,319 | | |
Total liabilities
|
| | | $ | 7,003,720 | | | | | $ | 423,734 | | | | | $ | 419,823 | | |
Total stockholders' equity
|
| | | $ | 685,510 | | | | | $ | 3,009,081 | | | | | $ | 2,398,496 | | |
| | |
For the Nine Months Ended
September 30, |
| |||||||||
| | |
2017
|
| |
2016
|
| ||||||
Direct clinical and non-clinical expenses
|
| | | $ | 1,820,737 | | | | | $ | 1,666,902 | | |
Personnel-related expenses
|
| | | | 285,775 | | | | | | 239,040 | | |
Facilities and other expenses
|
| | | | 19,481 | | | | | | 62,181 | | |
Travel and entertainment expenses
|
| | | | — | | | | | | 17,413 | | |
| | | | $ | 2,125,993 | | | | | $ | 1,985,536 | | |
|
| | |
For the Year Ended
December 31, |
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Direct clinical and non-clinical expenses
|
| | | $ | 2,555,998 | | | | | $ | 2,039,900 | | |
Personnel-related expenses
|
| | | | 318,720 | | | | | | 318,720 | | |
Facilities and other expenses
|
| | | | 72,119 | | | | | | 363,130 | | |
Travel and entertainment expenses
|
| | | | 19,328 | | | | | | 61,450 | | |
| | | | $ | 2,966,165 | | | | | $ | 2,783,200 | | |
|
|
Product Candidate
|
| |
Indication
|
| |
Next Expected Milestones
|
|
|
MicroProst
|
| |
Chronic Angle Closure Glaucoma
|
| |
Phase III IND H2 2018
|
|
|
MicroStat
|
| |
Mydriasis (Pupil Dilation)
|
| |
Phase III IND H2 2018
|
|
|
MicroTears
|
| |
Dry Eye
|
| |
OTC Registration H1 2019
|
|
|
MicroPine
|
| |
Myopia (Near Sightedness)
|
| |
Phase III IND H1 2019
|
|
Frequencies of Adverse Events (Safety Population)
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Latanoprost (n = 136)
|
| |
Bimatoprost (n = 137)
|
| |
Travoprost (n = 138)
|
| | ||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
n
|
| |
%
|
| |
No. of
Events |
| |
n
|
| |
%
|
| |
No. of
Events |
| |
n
|
| |
%
|
| |
No. of
Events |
| |
P
Value |
| ||||||||||||||||||||||||||||||
Patients with at least one adverse event
|
| | | | 87 | | | | | | 64.0 | | | | | | 137 | | | | | | 104 | | | | | | 75.9 | | | | | | 200 | | | | | | 95 | | | | | | 68.8 | | | | | | 159 | | | | | | .098 | | |
Patients with ocular adverse events
|
| | | | 73 | | | | | | 53.7 | | | | | | 110 | | | | | | 101 | | | | | | 73.7 | | | | | | 162 | | | | | | 89 | | | | | | 64.5 | | | | | | 129 | | | | | | .003 | | |
Patients with systemic adverse events
|
| | | | 23 | | | | | | 16.9 | | | | | | 27 | | | | | | 25 | | | | | | 18.2 | | | | | | 38 | | | | | | 23 | | | | | | 16.7 | | | | | | 30 | | | | | | .933 | | |
Patients with adverse events related to study medications
|
| | | | 70 | | | | | | 51.5 | | | | | | 90 | | | | | | 94 | | | | | | 68.6 | | | | | | 140 | | | | | | 81 | | | | | | 58.7 | | | | | | 108 | | | | | | .015 | | |
|
CONVENTIONAL EYE DROPPER USING CENTURY-OLD PIPETTE DELIVERY
×
Overdoses the eye by more than 400%
×
Causes overdose-related ocular toxicity (drug / preservative / excipient exposure)
•
Hyperemia / red eye
•
Discomfort / stinging
•
Itching
×
50–80% of eye drop applications miss the eye
|
| |
|
| |
EYENOVIA’S HIGH-PRECISION PIEZO-PRINT MICRODOSING
✓
Medication delivered directly to the cornea (primary site of ocular drug absorption)
✓
Gentle ocular surface microdroplet coating
✓
Less toxicity and drug/preservative exposure
✓
Fewer ocular side effects (redness, stinging)
✓
Lower systemic exposure
|
|
OCULAR ADVERSE EVENTS BY TREATMENT
|
| ||||||||||||
Adverse Event Description
|
| |
Eye Drop 10%
|
| |
EYE102 (Micro-dose 10%)
|
| ||||||
Ocular blurriness
|
| | | | 1 | | | | | | 0 | | |
Ocular burning/stinging/irritation
|
| | | | 4 | | | | | | 1 | | |
Ocular dryness
|
| | | | 2 | | | | | | 0 | | |
Subtotal by Treatment Group
|
| | | | 7 | | | | | | 1 | | |
|
Estimated population with CACG (thousands) by region (95% CI)
|
| |||||||||||||||||||||||||||
| | |
Number of CACG cases (thousands) 40 years old +
|
| |
% Increase in CACG cases relative to 2010
|
| |||||||||||||||||||||
| | |
UK
|
| |
Europe
|
| |
U.S.
|
| |
UK
|
| |
Europe
|
| |
U.S.
|
| |||||||||
2010 | | |
130 (71−211)
|
| |
1600 (873−2604)
|
| |
581 (309−958)
|
| | | | 1. | | | | | | • | | | | | | 2. | | |
2015 | | |
141 (77−229)
|
| |
1663 (902−2713)
|
| |
637 (338−1047)
|
| | | | 8.6 | | | | | | 3.9 | | | | | | 9.5 | | |
2020 | | |
154 (85−248)
|
| |
1743 (953−2837)
|
| |
687 (372−1124)
|
| | | | 19.0 | | | | | | 8.9 | | | | | | 18.2 | | |
2025 | | |
160 (89−258)
|
| |
1831 (1012−2967)
|
| |
743 (410−1206)
|
| | | | 23.6 | | | | | | 14.5 | | | | | | 27.8 | | |
2030 | | |
165 (93−265)
|
| |
1934 (1082−3115)
|
| |
812 (457−1304)
|
| | | | 27.5 | | | | | | 20.9 | | | | | | 39.6 | | |
2040 | | |
188 (108−302)
|
| |
2102 (1198−3344)
|
| |
930 (532−1478)
|
| | | | 44.9 | | | | | | 31.4 | | | | | | 59.9 | | |
2050 | | |
195 (112−309)
|
| |
2080 (1208−3285)
|
| |
973 (556−1550)
|
| | | | 50.7 | | | | | | 30.0 | | | | | | 67.4 | | |
| | | | | |
Latanoprost
|
| |
Timolol Maleate
|
| | |||||||||||||||||||||||
| | | | | | | | |
Decrease in IOP
|
| | | | |
Decrease in IOP
|
| | |||||||||||||||||
Time of IOP Recording
|
| |
Mean ± SD
Baseline IOP, mm Hg |
| |
Mean ± SD
IOP, mm Hg |
| |
Mean ± SD,
mm Hg |
| |
%
|
| |
Mean ± SD
IOP, mm Hg |
| |
Mean ± SD,
mm Hg |
| |
%
|
| |
P
Value |
| |||||||||
7 AM | | |
23.5 ± 3.1
|
| |
14.0 ± 2.2
|
| |
9.5 ± 3.3
|
| | | | 40.4 | | | |
18.3 ± 3.2
|
| |
5.2 ± 3.6
|
| | | | 22.1 | | | | | | <.01 | | |
10 AM | | |
24.6 ± 3.9
|
| |
14.6 ± 2.8
|
| |
10.0 ± 4.3
|
| | | | 40.6 | | | |
17.9 ± 3.6
|
| |
6.7 ± 3.5
|
| | | | 27.2 | | | | | | <.01 | | |
1 PM | | |
23.6 ± 2.7
|
| |
16.2 ± 2.7
|
| |
7.4 ± 3.4
|
| | | | 31.4 | | | |
17.1 ± 3.2
|
| |
6.5 ± 3.8
|
| | | | 27.5 | | | | | | .04 | | |
4 PM | | |
23.2 ± 2.7
|
| |
15.7 ± 3.4
|
| |
7.5 ± 3.3
|
| | | | 32.3 | | | |
17.7 ± 3.9
|
| |
5.6 ± 3.7
|
| | | | 24.1 | | | | | | <.01 | | |
7 PM | | |
22.4 ± 3.1
|
| |
15.6 ± 3.1
|
| |
6.8 ± 3.4
|
| | | | 30.4 | | | |
16.9 ± 3.8
|
| |
5.6 ± 3.9
|
| | | | 25.0 | | | | | | .01 | | |
10 PM | | |
23.3 ± 2.9
|
| |
15.6 ± 3.0
|
| |
7.6 ± 3.9
|
| | | | 32.6 | | | |
16.3 ± 3.4
|
| |
6.9 ± 3.6
|
| | | | 29.6 | | | | | | .25 | | |
Mean | | |
23.4 ± 2.1
|
| |
15.3 ± 1.8
|
| |
8.2 ± 2.0
|
| | | | 34.9 | | | |
17.4 ± 1.7
|
| |
6.1 ± 1.7
|
| | | | 26.0 | | | | | | <.01 | | |
Name
|
| |
Age
|
| |
Position
|
|
Tsontcho Ianchulev, M.D., M.P.H.
|
| |
44
|
| |
Chief Executive Officer, Chief Medical Officer and Director
|
|
Jennifer “Ginger” Clasby | | |
64
|
| | Vice President, Clinical Operations | |
Luke Clauson | | |
39
|
| | Vice President, Research & Development | |
Curt LaBelle, M.D., M.B.A | | |
47
|
| | Director | |
Fred Eshelman, Pharm.D. | | |
69
|
| | Director and Chairman | |
Ernest Mario, Ph.D. | | |
79
|
| | Director | |
Shuhei Yoshida | | |
45
|
| | Director | |
| | |
Option Awards
|
| ||||||||||||||||||||||||
Name
|
| |
Number of
securities underlying unexercised options (#) exercisable |
| |
Number of
securities underlying unexercised options (#) unexercisable |
| |
Equity
incentive plan awards; Number of securities underlying unexercised unearned options (#) |
| |
Option
exercise price ($) |
| |
Option
expiration date |
| ||||||||||||
Tsontcho Ianchulev
|
| | | | 675,000 (1) | | | | | | — | | | | | | — | | | | | $ | 0.33 | | | |
03/23/2025
|
|
Name of Beneficial Owner
|
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Shares Beneficially Owned
Prior to this Offering |
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Shares Beneficially Owned
After this Offering |
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Number
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| |
Percentage
(1)
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| |
Number
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Percentage
(2)
|
| |||||||||||
Tsontcho Ianchulev
(3)
|
| | | | 5,332,357 | | | | | | 17.4 % | | | | | | 5,332,357 | | | | ||
Jennifer “Ginger” Clasby
(4)
|
| | | | 58,487 | | | | | | * | | | | | | 58,487 | | | | ||
Luke Clauson
(5)
|
| | | | 73,109 | | | | | | * | | | | | | 73,109 | | | | ||
Curt LaBelle
(6)
|
| | | | 5,104,336 | | | | | | 16.8 % | | | | | | 5,104,336 | | | | ||
Fred Eshelman
(7)
|
| | | | 4,938,587 | | | | | | 15.9 % | | | | | | 4,938,587 | | | | ||
Ernest Mario
(8)
|
| | | | 758,177 | | | | | | 2.8 % | | | | | | 758,177 | | | | ||
Shuhei Yoshida
(9)
|
| | | | 6,142,537 | | | | | | 18.5 % | | | | | | 6,142,537 | | | | ||
All directors and executive officers as a group (7 persons)
(16)
|
| | | | 17,550,476 | | | | | | 42.1 % | | | | | | 17,550,476 | | | | ||
5% Stockholders: | | | | | | |||||||||||||||||
Senju Pharmaceuticals Co., Ltd.
(10)
|
| | | | 6,069,621 | | | | | | 18.3 % | | | | | | 6,069,621 | | | | ||
Private Medical Equity, Inc.
(11)
|
| | | | 2,800,000 | | | | | | 10.0 % | | | | | | 2,800,000 | | | | ||
PME Investor Services Eyenovia, LLC
(12)
|
| | | | 2,057,114 | | | | | | 7.1 % | | | | | | 2,057,114 | | | | ||
PointGuard Partners, LLC
(13)
|
| | | | 1,750,000 | | | | | | 6.5 % | | | | | | 1,750,000 | | | | ||
John J. Mack
(14)
|
| | | | 1,703,494 | | | | | | 6.1 % | | | | | | 1,703,494 | | | | ||
Barry Butler
(15)
|
| | | | 4,175,000 | | | | | | 15.1 % | | | | | | 4,175,000 | | | |