|
Delaware
|
| |
2836
|
| |
38-3982704
|
|
|
(State or other jurisdiction of
incorporation or organization) |
| |
(Primary Standard Industrial
Classification Code Number) |
| |
(I.R.S. Employer
Identification Number) |
|
|
Large accelerated filer ☐
|
| |
Accelerated filer ☐
|
| |
Non-accelerated filer ☐
(Do not check if a smaller reporting company) |
| |
Smaller reporting company ☒
|
|
CALCULATION OF REGISTRATION FEE
|
| ||||||||||||||||||||||||
Title of each class of securities to be registered issuable with respect to
the shares being registered hereunder |
| |
Amount to be
registered (1) |
| |
Proposed aggregate
offering price per security (2) |
| |
Proposed maximum
aggregate offering price (2) |
| |
Amount of
registration fee |
| ||||||||||||
Common stock, $0.01 par value per share
(2)
|
| | | | 5,114,747 | | | | | $ | 2.71 | | | | | $ | 13,860,964 | | | | | $ | 1,606.49 | | |
|
TABLE OF CONTENTS
|
| |
Page
|
| |||
| | | | 1 | | | |
| | | | 2 | | | |
| | | | 5 | | | |
| | | | 47 | | | |
| | | | 48 | | | |
| | | | 49 | | | |
| | | | 53 | | | |
| | | | 54 | | | |
| | | | 55 | | | |
| | | | 56 | | | |
| | | | 57 | | | |
| | | | 59 | | | |
| | | | 75 | | | |
| | | | 99 | | | |
| | | | 107 | | | |
| | | | 120 | | | |
| | | | 125 | | | |
| | | | 127 | | | |
| | | | 132 | | | |
| | | | 132 | | | |
| | | | 132 | | | |
| | | | F-1 | | |
|
Assumed Average
Purchase Price Per Share |
| |
Number of Registered
Shares to be Issued if Full Purchase (1)(2) |
| |
Percentage of Outstanding
Shares After Giving Effect to the Issuance to Lincoln Park (3) |
| |
Gross Proceeds from the Sale of
Registered Shares to Lincoln Park Under the Purchase Agreement |
| |||||||||
|
$1.50
(4)
|
| | | | 4,737,960 | | | | | | 16.5 % | | | | | $ | 7,106,940 | | |
|
$2.73
(5)
|
| | | | 4,737,960 | | | | | | 16.5 % | | | | | $ | 12,934,631 | | |
|
$3.00
|
| | | | 4,737,960 | | | | | | 16.5 % | | | | | $ | 14,213,880 | | |
|
$4.00
|
| | | | 3,750,000 | | | | | | 13.6 % | | | | | $ | 15,000,000 | | |
|
$5.00
|
| | | | 3,000,000 | | | | | | 11.1 % | | | | | $ | 15,000,000 | | |
| | |
Common Stock
|
| |||||||||
| | |
High
|
| |
Low
|
| ||||||
Fiscal Year 2017 Year-to-Date | | | | ||||||||||
Second quarter (through March 9, 2017)
|
| | | $ | 3.95 | | | | | $ | 2.40 | | |
First quarter
|
| | | | 3.61 | | | | | | 3.40 | | |
Fiscal Year Ended September 30, 2016 | | | | ||||||||||
Fourth quarter
|
| | | | 5.49 | | | | | | 3.04 | | |
Third quarter (from June 13, 2016)
|
| | | | 4.48 | | | | | | 3.25 | | |
Selling Stockholder
|
| |
Shares
Beneficially Owned Before this Offering |
| |
Percentage
of Outstanding Shares Beneficially Owned Before this Offering |
| |
Shares to be
Sold in this Offering Assuming We Issue the Maximum Number of Shares Under the Purchase Agreement |
| |
Percentage
of Outstanding Shares Beneficially Owned After this Offering |
| ||||||||||||
Lincoln Park Capital Fund, LLC
(1)
|
| | | | 263,581 (2 ) | | | | | | 1.1 % (3) | | | | | | 5,114,747 (4 ) | | | | | | * | | |
| | |
Year ended September 30,
|
| |
Three months ended
December 31, |
| ||||||||||||||||||
| | |
2016
|
| |
2015
|
| |
2016
|
| |
2015
|
| ||||||||||||
IPCA collaboration
|
| | | $ | 421,732 | | | | | $ | 1,702,377 | | | | | $ | 65,268 | | | | | $ | 105,433 | | |
Liomont collaboration
|
| | | | 1,382,264 | | | | | | 341,280 | | | | | | 59,160 | | | | | | 595,566 | | |
Huahai collaboration
|
| | | | 1,175,580 | | | | | | 3,175,580 | | | | | | 178,712 | | | | | | 293,895 | | |
| | | | $ | 2,979,576 | | | | | $ | 5,219,237 | | | | | $ | 303,140 | | | | | $ | 994,894 | | |
|
| | |
Year ended September 30,
|
| |
Three months ended
December 31, |
| ||||||||||||||||||
| | |
2016
|
| |
2015
|
| |
2016
|
| |
2015
|
| ||||||||||||
Milestone payments
|
| | | $ | 1,000,000 | | | | | $ | 2,500,000 | | | | | $ | — | | | | | $ | 500,000 | | |
Recognition of deferred revenues
|
| | | | 1,979,576 | | | | | | 1,919,237 | | | | | | 303,140 | | | | | | 494,894 | | |
Research and development payments
|
| | | | — | | | | | | 800,000 | | | | | | — | | | | | | — | | |
| | | | $ | 2,979,576 | | | | | $ | 5,219,237 | | | | | $ | 303,140 | | | | | $ | 994,894 | | |
|
| | |
Three Months ended
December 31, |
| |
Change
|
| ||||||||||||
| | |
2016
|
| |
2015
|
| ||||||||||||
Collaboration revenues
|
| | | $ | 303,140 | | | | | $ | 994,894 | | | | | $ | (691,754 ) | | |
Operating expenses: | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | 13,312,306 | | | | | | 12,733,976 | | | | | | 578,330 | | |
General and administrative
|
| | | | 4,888,860 | | | | | | 4,674,155 | | | | | | 214,705 | | |
| | | | | 18,201,166 | | | | | | 17,408,131 | | | | | | 793,035 | | |
Loss from operations
|
| | | | (17,898,026 ) | | | | | | (16,413,237 ) | | | | | | (1,484,789 ) | | |
Interest expense
|
| | | | 386,713 | | | | | | 398,975 | | | | | | (12,262 ) | | |
Change in fair value of warrant liability
|
| | | | 810,083 | | | | | | — | | | | | | 810,083 | | |
Loss before income taxes
|
| | | | (19,094,822 ) | | | | | | (16,812,212 ) | | | | | | (2,282,610 ) | | |
Income tax expense
|
| | | | 4,000 | | | | | | 52,000 | | | | | | (48,000 ) | | |
Net loss
|
| | | $ | (19,098,822 ) | | | | | $ | (16,864,212 ) | | | | | $ | (2,234,610 ) | | |
|
| | |
Three months ended December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Preclinical and clinical development
|
| | | $ | 8,944,890 | | | | | $ | 7,007,033 | | |
Compensation and related benefits
|
| | | | 2,469,609 | | | | | | 2,054,773 | | |
Stock-based compensation
|
| | | | 386,109 | | | | | | 1,356,408 | | |
Other research and development
|
| | | | 1,511,698 | | | | | | 2,315,762 | | |
Total research and development expenses
|
| | | $ | 13,312,306 | | | | | $ | 12,733,976 | | |
|
| | |
Three months ended December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
ONS-3010
|
| | | $ | 5,590,557 | | | | | $ | 4,379,396 | | |
ONS-1045
|
| | | | 2,755,025 | | | | | | 2,158,166 | | |
Early-stage compounds
|
| | | | 599,308 | | | | | | 469,471 | | |
Personnel related and stock-based compensation
|
| | | | 2,855,718 | | | | | | 3,411,181 | | |
Other research and development
|
| | | | 1,511,698 | | | | | | 2,315,762 | | |
Total research and development expenses
|
| | | $ | 13,312,306 | | | | | $ | 12,733,976 | | |
|
| | |
Three months ended December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Professional fees
|
| | | $ | 1,177,179 | | | | | $ | 2,288,093 | | |
Compensation and related benefits
|
| | | | 722,134 | | | | | | 692,689 | | |
Stock-based compensation
|
| | | | 2,077,943 | | | | | | 1,133,626 | | |
Facilities, fees and other related costs
|
| | | | 911,604 | | | | | | 559,747 | | |
Total general and administration expenses
|
| | | $ | 4,888,860 | | | | | $ | 4,674,155 | | |
|
| | |
Year ended September 30,
|
| | ||||||||||||||
| | |
2016
|
| |
2015
|
| |
Change
|
| |||||||||
Collaboration revenues
|
| | | $ | 2,979,576 | | | | | $ | 5,219,237 | | | | | $ | (2,239,661 ) | | |
Operating expenses: | | | | | |||||||||||||||
Research and development
|
| | | | 33,101,543 | | | | | | 38,876,040 | | | | | | (5,774,497 ) | | |
General and administrative
|
| | | | 21,636,345 | | | | | | 12,905,823 | | | | | | 8,730,522 | | |
| | | | | 54,737,888 | | | | | | 51,781,863 | | | | | | 2,956,025 | | |
Loss from operations
|
| | | | (51,758,312 ) | | | | | | (46,562,626 ) | | | | | | (5,195,686 ) | | |
Interest expense
|
| | | | 1,467,950 | | | | | | 2,297,339 | | | | | | (829,389 ) | | |
Loss before income taxes
|
| | | | (53,226,262 ) | | | | | | (48,859,965 ) | | | | | | (4,366,297 ) | | |
Income tax expense (benefit)
|
| | | | 103,000 | | | | | | (190,111 ) | | | | | | 293,111 | | |
Net loss
|
| | | $ | (53,329,262 ) | | | | | $ | (48,669,854 ) | | | | | $ | (4,659,408 ) | | |
|
| | |
Year ended September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Preclinical and clinical development
|
| | | $ | 14,820,730 | | | | | $ | 21,469,678 | | |
Compensation and related benefits
|
| | | | 9,214,216 | | | | | | 6,576,810 | | |
Stock-based compensation
|
| | | | 2,044,379 | | | | | | 5,817,830 | | |
Other research and development
|
| | | | 7,022,218 | | | | | | 5,011,722 | | |
Total research and development expenses
|
| | | $ | 33,101,543 | | | | | $ | 38,876,040 | | |
|
| | |
Year ended September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
ONS-3010
|
| | | $ | 10,124,418 | | | | | $ | 7,894,315 | | |
ONS-1045
|
| | | | 4,088,686 | | | | | | 12,763,886 | | |
Early-stage compounds
|
| | | | 607,626 | | | | | | 811,477 | | |
Personnel related and stock-based compensation
|
| | | | 11,258,595 | | | | | | 12,394,640 | | |
Other research and development
|
| | | | 7,022,218 | | | | | | 5,011,722 | | |
Total research and development expenses
|
| | | $ | 33,101,543 | | | | | $ | 38,876,040 | | |
|
| | |
Year ended September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Professional fees
|
| | | $ | 4,549,315 | | | | | $ | 2,724,465 | | |
Compensation and related benefits
|
| | | | 4,131,014 | | | | | | 2,579,810 | | |
Stock-based compensation
|
| | | | 10,405,700 | | | | | | 5,360,027 | | |
Facilities, fees and other related costs
|
| | | | 2,550,316 | | | | | | 2,241,521 | | |
Total general and administration expenses
|
| | | $ | 21,636,345 | | | | | $ | 12,905,823 | | |
|
| | |
Year ended September 30,
|
| |
Three months ended
December 31, |
| ||||||||||||||||||
| | |
2016
|
| |
2015
|
| |
2016
|
| |
2015
|
| ||||||||||||
Net cash used in operating activities
|
| | | $ | (45,482,672 ) | | | | | $ | (27,476,200 ) | | | | | $ | (5,841,668 ) | | | | | $ | (12,012,281 ) | | |
Net cash used in investing activities
|
| | | | (1,098,180 ) | | | | | | (8,804,244 ) | | | | | | (148,362 ) | | | | | | (364,242 ) | | |
Net cash provided by financing activities
|
| | | | 39,861,764 | | | | | | 43,002,106 | | | | | | 5,716,678 | | | | | | 8,887,803 | | |
Net (decrease) increase in cash
|
| | | $ | (6,719,088 ) | | | | | $ | 6,721,662 | | | | | $ | (273,352 ) | | | | | $ | (3,488,720 ) | | |
|
| | |
Payments Due by Period
|
| |||||||||||||||||||||||||||
| | |
Total
|
| |
Less Than
1 Year |
| |
1 – 3
Years |
| |
3 – 5
Years |
| |
More Than
5 Years |
| |||||||||||||||
Operating lease commitments
(1)
|
| | | $ | 11,950,610 | | | | | $ | 1,551,513 | | | | | $ | 3,488,586 | | | | | $ | 3,368,521 | | | | | $ | 3,541,990 | | |
Debt obligations
(2)(3)
|
| | | | 7,493,981 | | | | | | 5,198,954 | | | | | | 1,065,487 | | | | | | 1,066,633 | | | | | | 162,907 | | |
Capital leases
(4)
|
| | | | 1,297,985 | | | | | | 977,248 | | | | | | 320,737 | | | | | | — | | | | | | — | | |
Total
(5)
|
| | | $ | 20,742,576 | | | | | $ | 7,727,715 | | | | | $ | 4,874,810 | | | | | $ | 4,435,154 | | | | | $ | 3,704,897 | | |
|
| | |
Year ended September 30,
|
| |
Three months ended
December 31, |
| ||||||||||||||||||
| | |
2016
|
| |
2015
|
| |
2016
|
| |
2015
|
| ||||||||||||
Research and development
|
| | | $ | 2,044,379 | | | | | $ | 5,817,830 | | | | | $ | 386,109 | | | | | $ | 1,356,408 | | |
General and administrative
|
| | | | 10,405,700 | | | | | | 5,360,028 | | | | | | 2,077,943 | | | | | | 1,133,626 | | |
| | | | $ | 12,450,079 | | | | | $ | 11,177,858 | | | | | $ | 2,464,052 | | | | | $ | 2,490,034 | | |
|
| | |
Year ended September 30,
|
| |
Three months ended
December 31, |
| ||||||||||||||||||
| | |
2016
|
| |
2015
|
| |
2016
|
| |
2015
|
| ||||||||||||
Equity-classified compensation
|
| | | $ | 10,058,217 | | | | | $ | 8,925 | | | | | $ | 2,464,052 | | | | | $ | 98,172 | | |
Liability-classified compensation
|
| | | | 2,391,862 | | | | | | 11,168,933 | | | | | | — | | | | | | 2,391,862 | | |
| | | | $ | 12,450,079 | | | | | $ | 11,177,858 | | | | | $ | 2,464,052 | | | | | $ | 2,490,034 | | |
|
|
|
| |
|
|
Adverse Event
|
| |
ONS-3010
N (%) |
| |
EU-Humira
N (%) |
| |
U.S.-Humira
N (%) |
| |||||||||
Burning sensation
|
| | | | 12 (18.2 ) | | | | | | 29 (43.9 ) | | | | | | 31 (47.0 ) | | |
Headache
|
| | | | 29 (43.9 ) | | | | | | 20 (30.3 ) | | | | | | 27 (39.4 ) | | |
Nasopharyngitis
|
| | | | 12 (18.2 ) | | | | | | 19 (28.8 ) | | | | | | 12 (18.2 ) | | |
Name
|
| |
Age
|
| |
Position(s)
|
| |||
Executive Officers | | | | | | | | | | |
Pankaj Mohan, Ph.D.
|
| | | | 52 | | | | Chairman, President and Chief Executive Officer | |
Kenneth M. Bahrt, M.D.
|
| | | | 63 | | | | Chief Medical Officer | |
Kogan Bao, Ph.D.
|
| | | | 47 | | | | Vice President, Analytical Sciences | |
Scott A. Gangloff
|
| | | | 43 | | | | Senior Vice President, Development & Manufacturing | |
Lawrence A. Kenyon
|
| | | | 51 | | | | Chief Financial Officer and Secretary | |
Stephen J. McAndrew, Ph.D.
|
| | | | 62 | | | |
Senior Vice President, Business Strategy & Development
|
|
Elizabeth A. Yamashita
|
| | | | 56 | | | | Vice President, Regulatory Affairs | |
Non-Employee Directors | | | | | | | | | | |
Todd C. Brady, M.D., Ph.D.
(1)(3)
|
| | | | 45 | | | | Director | |
Scott Canute
(2)
|
| | | | 56 | | | | Director | |
Albert D. Dyrness
(2)(3)
|
| | | | 54 | | | | Director | |
Donald J. Griffith
|
| | | | 68 | | | | Director | |
Kurt J. Hilzinger
(1)(2)
|
| | | | 56 | | | | Director | |
Robin Smith Hoke
(1)(3)
|
| | | | 54 | | | | Director | |
Name
|
| |
Fees Earned
or Paid in Cash (1) ($) |
| |
Total
($) |
| ||||||
Todd C. Brady, M.D., Ph.D.
|
| | | | 17,867 | | | | | | 17,867 | | |
Scott Canute
|
| | | | 19,212 | | | | | | 19,212 | | |
Albert Dyrness
|
| | | | 19,789 | | | | | | 19,789 | | |
Donald J. Griffith
|
| | | | 13,449 | | | | | | 13,449 | | |
Kurt Hilzinger
|
| | | | 24,015 | | | | | | 24,015 | | |
Robin Smith Hoke
|
| | | | 18,060 | | | | | | 18,060 | | |
Board Committee
|
| |
Chairperson Fee
|
| |
Member Fee
|
| ||||||
Audit Committee
|
| | | $ | 15,000 | | | | | $ | 7,500 | | |
Compensation Committee
|
| | | | 10,000 | | | | | | 5,000 | | |
Nominating and Corporate Governance Committee
|
| | | | 8,000 | | | | | | 4,000 | | |
Name and Principal Position
|
| |
Year
|
| |
Salary
($) |
| |
Bonus
($) (1) |
| |
Equity Plan
Awards ($) (2) |
| |
All Other
Compensation ($) (3) |
| |
Total
($) |
| ||||||||||||||||||
Pankaj Mohan, Ph.D.
Chairman, President and Chief Executive Officer |
| | | | 2016 | | | | | | 369,926 | | | | | | 990,000 | | | | | | 11,787,997 | | | | | | 26,658 | | | | | | 13,174,581 | | |
| | | 2015 | | | | | | 290,004 | | | | | | — | | | | | | — | | | | | | 29,839 | | | | | | 319,843 | | | ||
Lawrence A. Kenyon
(4)
Chief Financial Officer |
| | | | 2016 | | | | | | 309,359 | | | | | | — | | | | | | 1,262,992 | | | | | | 17,727 | | | | | | 1,590,078 | | |
| | | 2015 | | | | | | 14,000 | | | | | | — | | | | | | — | | | | | | — | | | | | | 14,000 | | | ||
Kogan Bao, Ph.D.
(5)
Vice President, Analytical Sciences |
| | | | 2016 | | | | | | 160,309 | | | | | | — | | | | | | 260,868 | | | | | | 7,798 | | | | | | 428,975 | | |
| | | 2015 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
| | | | | | | | |
Equity Awards
(1)
|
| |||||||||||||||||||||
| | |
Grant Date
|
| |
Number of
Securities Underlying Unexercised RSUs Exercisable (#) |
| |
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned RSUs (#) |
| |
Exercise
Price ($) |
| |
Expiration
Date |
| |||||||||||||||
Pankaj Mohan, Ph.D.
|
| | | | 12/31/2015 | | | | | | 405,797 | | | | | | — | | | | | | — | | | | | | — | | |
Lawrence A. Kenyon
|
| | | | 12/31/2015 | | | | | | 43,478 (2) | | | | | | — | | | | | | — | | | | | | — | | |
Kogan Bao, Ph.D.
|
| | | | 04/11/2016 | | | | | | 21,739 (3) | | | | | | — | | | | | | — | | | | | | — | | |
Related Party
|
| |
# of Shares of
Series A Redeemable Preferred Stock Converted |
| |
# of Shares of
Common Stock Received Upon Conversion |
| |
# of Shares of
DE Series A Preferred Stock Received Upon Conversion |
|
Mr. Canute
|
| |
250 shares
|
| |
72,463 shares
|
| |
351 shares
|
|
Dr. Brady
|
| |
100 shares
|
| |
28,985 shares
|
| |
141 shares
|
|
Dr. Mohan’s immediate family
|
| |
150 shares
|
| |
43,478 shares
|
| |
212 shares
|
|
Mr. Gangloff’s immediate family
|
| |
55 shares
|
| |
15,942 shares
|
| |
79 shares
|
|
Mr. Griffith’s immediate family
|
| |
35 shares
|
| |
10,144 shares
|
| |
50 shares
|
|
Related Party
|
| |
# of Series A
Redeemable Preferred Stock Repurchased |
| |
Cash Received
|
| |
Principal
Amount of 4% Promissory Notes Received |
| |||||||||
Dr. Mohan
|
| | | | 175 | | | | | $ | — | | | | | $ | 423,003 | | |
Mr. Canute
|
| | | | 900 | | | | | $ | 500,000 | | | | | $ | 1,511,384 | | |
Mr. Griffith and his immediate family
|
| | | | 165 | | | | | $ | 130,000 | | | | | $ | 247,068 | | |
Mr. Gangloff’s immediate family
|
| | | | 45 | | | | | $ | 90,000 | | | | | $ | 12,580 | | |
Mr. Dyrness’ affiliate
|
| | | | 100 | | | | | $ | 200,000 | | | | | $ | 35,107 | | |
Related Party
|
| |
Restricted Stock
|
| |
PSUs
|
| ||||||
Mr. Gangloff
|
| | | | 115,942 | | | | | | 129,855 | | |
Mr. Griffith
|
| | | | 144,927 | | | | | | 162,318 | | |
Dr. McAndrew
|
| | | | 57,971 | | | | | | 64,927 | | |
Ms. Yamashita
|
| | | | 43,478 | | | | | | 48,695 | | |
Name of Beneficial Owner
|
| |
Number
|
| |
Percentage of Shares
Beneficially Owned |
| ||||||
Five Percent Stockholders (other than directors and officers): | | | | ||||||||||
Perceptive Advisors, LLC
(1)
|
| | | | 2,456,490 | | | | | | 9.9 % | | |
Sabby Management, LLC
(2)
|
| | | | 2,376,202 | | | | | | 9.9 % | | |
Strides Pharma (UK) Limited
(3)
|
| | | | 1,739,130 | | | | | | 7.4 % | | |
venBio Select Advisor
(4)
|
| | | | 1,301,425 | | | | | | 5.4 % | | |
Named Executive Officers and Directors: | | | | ||||||||||
Pankaj Mohan, Ph.D.,
Chairman, President and Chief Executive Officer
(5)
|
| | | | 7,691,575 | | | | | | 32.3 % | | |
Lawrence A. Kenyon,
Chief Financial Officer
(6)
|
| | | | — | | | | | | — | | |
Kogan Bao, Ph.D.,
Vice President, Analytical Sciences
(7)
|
| | | | — | | | | | | — | | |
Todd C. Brady, M.D., Ph.D.,
Director
(8)
|
| | | | 153,288 | | | | | | * | | |
Scott Canute,
Director
(9)
|
| | | | 364,157 | | | | | | 1.5 % | | |
Albert D. Dyrness,
Director
(10)
|
| | | | 11,500 | | | | | | — | | |
Donald J. Griffith,
Director
(11)
|
| | | | 144,926 | | | | | | — | | |
Kurt J. Hilzinger,
Director
(12)
|
| | | | 30,544 | | | | | | — | | |
Robin Smith Hoke,
Director
(13)
|
| | | | 3,199 | | | | | | — | | |
All executive officers and directors as a group (13 persons)
|
| | | | 8,518,376 | | | | | | 35.6 % | | |
| | |
Page
|
| |||
| | | | F-2 | | | |
| | | | F-3 | | | |
| | | | F-4 | | | |
| | | | F-5 | | | |
| | | | F-6 | | | |
| | | | F-7 | | | |
Unaudited Interim Financial Statements | | | |||||
| | | | F-26 | | | |
| | | | F-27 | | | |
| | | | F-28 | | | |
| | | | F-29 | | | |
| | | | F-30 | | |
| | |
September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Assets | | | | ||||||||||
Current assets: | | | | | | | | | | | | | |
Cash
|
| | | $ | 2,351,887 | | | | | $ | 9,070,975 | | |
Accounts receivable
|
| | | | — | | | | | | 20,000 | | |
Stock subscription receivable
|
| | | | — | | | | | | 4,280,149 | | |
Prepaid and other current assets
|
| | | | 3,326,607 | | | | | | 1,793,109 | | |
Total current assets
|
| | | | 5,678,494 | | | | | | 15,164,233 | | |
Property and equipment, net
|
| | | | 16,958,553 | | | | | | 17,759,938 | | |
Restricted cash
|
| | | | 216,086 | | | | | | 213,663 | | |
Deferred offering costs
|
| | | | — | | | | | | 960,563 | | |
Other assets
|
| | | | 852,801 | | | | | | 910,224 | | |
Total assets
|
| | | $ | 23,705,934 | | | | | $ | 35,008,621 | | |
Liabilities, redeemable preferred stock, common stock, noncontrolling interests and stockholders’ equity (deficit) | | ||||||||||||
Current liabilities: | | | | ||||||||||
Current portion of debt
|
| | | $ | 586,454 | | | | | $ | 742,646 | | |
Current portion of capital lease obligations
|
| | | | 977,248 | | | | | | 862,849 | | |
Current portion of stockholder notes
|
| | | | 4,612,500 | | | | | | 14,214,196 | | |
Accounts payable
|
| | | | 5,071,520 | | | | | | 11,563,055 | | |
Accrued expenses
|
| | | | 6,121,942 | | | | | | 5,924,648 | | |
Income taxes payable
|
| | | | 1,854,629 | | | | | | 1,754,629 | | |
Deferred revenue
|
| | | | 1,212,561 | | | | | | 1,979,576 | | |
Total current liabilities
|
| | | | 20,436,854 | | | | | | 37,041,599 | | |
Long-term debt
|
| | | | 2,233,803 | | | | | | 2,922,764 | | |
Capital lease obligations
|
| | | | 320,737 | | | | | | 1,219,373 | | |
Stockholder notes
|
| | | | — | | | | | | 2,000,000 | | |
Deferred revenue
|
| | | | 5,153,384 | | | | | | 6,365,945 | | |
Stock-based compensation liability
|
| | | | — | | | | | | 12,726,722 | | |
Other liabilities
|
| | | | 761,334 | | | | | | 284,710 | | |
Total liabilities
|
| | | | 28,906,112 | | | | | | 62,561,113 | | |
Commitments (Note 9) | | | | ||||||||||
Redeemable preferred stock, common stock and noncontrolling interests: | | | | | | | | | | | | | |
Redeemable preferred stock, no par value:
|
| | | | | | | | | | | | |
Series A – No shares authorized, issued and outstanding at September 30, 2016; 8,000 shares
authorized; 3,568 issued and outstanding at September 30, 2015 |
| | | | — | | | | | | 5,072,653 | | |
Series B – No shares authorized, issued and outstanding at September 30, 2016; 4,000 shares
authorized, issued and outstanding at September 30, 2015; |
| | | | — | | | | | | 5,118,208 | | |
Redeemable common stock – 1,739,130 shares issued and outstanding at September 30,
2015 |
| | | | — | | | | | | 15,426,673 | | |
Redeemable noncontrolling interests
|
| | | | — | | | | | | 1,703,777 | | |
Total redeemable preferred stock, common stock and noncontrolling interests
|
| | | | — | | | | | | 27,321,311 | | |
Stockholders’ equity (deficit): | | | | ||||||||||
Series A preferred stock, par value $0.01 per share: 10,000,000 shares authorized, no shares issued and outstanding
|
| | | | — | | | | | | — | | |
Common stock, par value $0.01 per share; 200,000,000 shares authorized at September 30, 2016; 22,802,778 shares issued and outstanding at September 30, 2016; No shares authorized, issued and outstanding at September 30, 2015
|
| | | | 228,028 | | | | | | — | | |
Common stock, no shares authorized issued and outstanding at September 30, 2016; no par value; 100,000,000 shares authorized; 9,436,294 shares issued and outstanding at September 30, 2015
|
| | | | — | | | | | | 39,844,900 | | |
Additional paid-in capital
|
| | | | 141,965,342 | | | | | | — | | |
Accumulated deficit
|
| | | | (147,393,548 ) | | | | | | (94,064,286 ) | | |
Total Oncobiologics, Inc. stockholders’ equity (deficit)
|
| | | | (5,200,178 ) | | | | | | (54,219,386 ) | | |
Noncontrolling interests
|
| | | | — | | | | | | (654,417 ) | | |
Total stockholders’ equity (deficit)
|
| | | | (5,200,178 ) | | | | | | (54,873,803 ) | | |
Total liabilities, redeemable preferred stock, common stock, noncontrolling interests and stockholders’ equity (deficit)
|
| | | $ | 23,705,934 | | | | | $ | 35,008,621 | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Collaboration revenues
|
| | | $ | 2,979,576 | | | | | $ | 5,219,237 | | |
Operating expenses: | | | | | | | | | | | | | |
Research and development
|
| | | | 33,101,543 | | | | | | 38,876,040 | | |
General and administrative
|
| | | | 21,636,345 | | | | | | 12,905,823 | | |
| | | | | 54,737,888 | | | | | | 51,781,863 | | |
Loss from operations
|
| | | | (51,758,312 ) | | | | | | (46,562,626 ) | | |
Interest expense, net
|
| | | | 1,467,950 | | | | | | 2,297,339 | | |
Loss before income taxes
|
| | | | (53,226,262 ) | | | | | | (48,859,965 ) | | |
Income tax expense (benefit)
|
| | | | 103,000 | | | | | | (190,111 ) | | |
Net loss
|
| | | | (53,329,262 ) | | | | | | (48,669,854 ) | | |
Less: Net loss attributable to noncontrolling interests
|
| | | | — | | | | | | (1,276,571 ) | | |
Net loss attributable to Oncobiologics, Inc.
|
| | | | (53,329,262 ) | | | | | | (47,393,283 ) | | |
Accretion of redeemable preferred stock and noncontrolling interests
|
| | | | (2,463,160 ) | | | | | | (4,306,488 ) | | |
Deemed dividends upon the repurchase of Series A redeemable preferred stock and redeemable noncontrolling interests
|
| | | | — | | | | | | (1,298,631 ) | | |
Deemed dividend upon issuance of warrants to common stockholders
|
| | | | (7,373,820 ) | | | | | | — | | |
Net loss attributable to common stockholders of Oncobiologics, Inc.
|
| | | $ | (63,166,242 ) | | | | | $ | (52,998,402 ) | | |
Per share information: | | | | | | | | | | | | | |
Net loss per share of common stock, basic and diluted
|
| | | $ | (3.67 ) | | | | | $ | (5.43 ) | | |
Weighted average shares outstanding, basic and diluted
|
| | | | 17,212,983 | | | | | | 9,753,616 | | |
|
| | |
Redeemable Preferred Stock, Common Stock and Noncontrolling Interests
|
| | |
Stockholders’ Equity (Deficit)
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Preferred Stock
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Additional
Paid-in Capital |
| |
Accumulated
Deficit |
| |
Noncontrolling
Interests |
| |
Total
Stockholders’ Equity (Deficit) |
| |||||||||||||||||||||||||||||||||
| | |
Series A
|
| |
Series B
|
| |
Common Stock
|
| |
Noncontrolling
Interests |
| | |
Series A Preferred Stock
|
| |
Common Stock
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at October 1, 2014
|
| | | | 3,681 | | | | | $ | 4,787,996 | | | | | | 4,000 | | | | | $ | 4,589,872 | | | | | | 1,739,130 | | | | | $ | 12,225,096 | | | | | $ | 3,101,047 | | | | | | | — | | | | | $ | — | | | | | | 7,670,783 | | | | | $ | — | | | | | $ | — | | | | | $ | (45,151,218 ) | | | | | $ | — | | | | | $ | (45,151,218 ) | | |
Distribution of common stock in Sonnet Biotherapeutics, Inc. to stockholders
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (221,154 ) | | | | | | 221,154 | | | | | | — | | |
Contributions to noncontrolling interests
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 401,000 | | | | | | 401,000 | | |
Repurchase of Series A redeemable preferred
stock and deemed dividends |
| | | | (113 ) | | | | | | (142,370 ) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (83,631 ) | | | | | | — | | | | | | (83,631 ) | | |
Repurchase of redeemable noncontrolling interests and deemed dividends
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,546,818 ) | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,215,000 ) | | | | | | — | | | | | | (1,215,000 ) | | |
Forfeitures of restricted stock
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Sale of common stock, net of issuance
costs |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 1,765,511 | | | | | | 44,142,463 | | | | | | — | | | | | | — | | | | | | — | | | | | | 44,142,463 | | |
Accretion of redeemable preferred stock, common stock and noncontrolling
interests |
| | | | — | | | | | | 427,027 | | | | | | — | | | | | | 528,336 | | | | | | — | | | | | | 3,201,577 | | | | | | 149,548 | | | | | | | — | | | | | | — | | | | | | — | | | | | | (4,306,488 ) | | | | | | — | | | | | | — | | | | | | — | | | | | | (4,306,488 ) | | |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | 8,925 | | | | | | — | | | | | | — | | | | | | — | | | | | | 8,925 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (47,393,283 ) | | | | | | (1,276,571 ) | | | | | | (48,669,854 ) | | |
Balance at September 30, 2015
|
| | | | 3,568 | | | | | | 5,072,653 | | | | | | 4,000 | | | | | | 5,118,208 | | | | | | 1,739,130 | | | | | | 15,426,673 | | | | | | 1,703,777 | | | | | | | — | | | | | | — | | | | | | 9,436,294 | | | | | | 39,844,900 | | | | | | — | | | | | | (94,064,286 ) | | | | | | (654,417 ) | | | | | | (54,873,803 ) | | |
Deconsolidation of Sonnet Biotherapeutics, Inc.
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 654,417 | | | | | | 654,417 | | |
Employee tax withholdings related to the vesting of restricted stock
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | (2,782 ) | | | | | | (71,760 ) | | | | | | — | | | | | | — | | | | | | — | | | | | | (71,760 ) | | |
Reincorporation to a Delaware Corporation
|
| | | | (3,568 ) | | | | | | (5,072,653 ) | | | | | | (4,000 ) | | | | | | (5,118,208 ) | | | | | | — | | | | | | — | | | | | | — | | | | | | | 10,193 | | | | | | 102 | | | | | | 2,193,601 | | | | | | (39,656,869 ) | | | | | | 49,847,628 | | | | | | — | | | | | | — | | | | | | 10,190,861 | | |
Issuance of common stock upon the dissolution of Parilis
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,703,777 ) | | | | | | | 1,626 | | | | | | 16 | | | | | | 226,663 | | | | | | 2,267 | | | | | | 1,701,494 | | | | | | — | | | | | | — | | | | | | 1,703,777 | | |
Sale of common stock, net of issuance
costs |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 573,388 | | | | | | 5,734 | | | | | | 16,132,179 | | | | | | — | | | | | | — | | | | | | 16,137,913 | | |
Reclassification of stock-based compensation
liability |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 15,118,584 | | | | | | — | | | | | | — | | | | | | 15,118,584 | | |
Accretion of redeemable common
stock |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 2,463,160 | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (2,463,160 ) | | | | | | — | | | | | | — | | | | | | (2,463,160 ) | | |
Sale of common stock units upon
consummation of initial public offering and concurrent private placement, net of issuance costs |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 6,666,666 | | | | | | 66,667 | | | | | | 33,717,538 | | | | | | 33,784,205 | | | | | | — | | | | | | 33,784,205 | | |
Reclassification of redeemable common stock
upon consummation of the initial public offering |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,739,130 ) | | | | | | (17,889,833 ) | | | | | | — | | | | | | | — | | | | | | — | | | | | | 1,739,130 | | | | | | 17,391 | | | | | | 17,872,442 | | | | | | — | | | | | | — | | | | | | 17,889,833 | | |
Conversion of Series A preferred stock in connection with the initial public
offering |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | (11,819 ) | | | | | | (118 ) | | | | | | 1,969,818 | | | | | | 19,698 | | | | | | (19,580 ) | | | | | | — | | | | | | — | | | | | | — | | |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 10,058,217 | | | | | | — | | | | | | — | | | | | | 10,058,217 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (53,329,262 ) | | | | | | — | | | | | | (53,329,262 ) | | |
Balance at September 30, 2016
|
| | | | — | | | | | $ | — | | | | | | — | | | | | $ | — | | | | | | — | | | | | $ | — | | | | | $ | — | | | | | | | — | | | | | $ | — | | | | | | 22,802,778 | | | | | $ | 228,028 | | | | | $ | 141,965,342 | | | | | $ | (147,393,548 ) | | | | | $ | — | | | | | $ | (5,200,178 ) | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
OPERATING ACTIVITIES | | | | ||||||||||
Net loss
|
| | | $ | (53,329,262 ) | | | | | $ | (48,669,854 ) | | |
Adjustments to reconcile net loss to net cash used in operating activities:
|
| | | ||||||||||
Depreciation and amortization
|
| | | | 2,394,279 | | | | | | 1,824,600 | | |
Non-cash interest expense
|
| | | | 13,465 | | | | | | 12,264 | | |
Stock-based compensation
|
| | | | 12,450,079 | | | | | | 11,177,858 | | |
Loss on disposal of fixed assets
|
| | | | 13,647 | | | | | | — | | |
Changes in operating assets and liabilities:
|
| | | ||||||||||
Accounts receivable
|
| | | | 20,000 | | | | | | (20,000 ) | | |
Prepaid expenses and other current assets
|
| | | | (1,533,498 ) | | | | | | (1,021,852 ) | | |
Other assets
|
| | | | 57,423 | | | | | | (322,729 ) | | |
Accounts payable
|
| | | | (5,326,374 ) | | | | | | 6,580,722 | | |
Accrued expenses
|
| | | | 1,154,712 | | | | | | 2,240,800 | | |
Income taxes payable
|
| | | | 100,000 | | | | | | 190,218 | | |
Deferred revenue
|
| | | | (1,979,576 ) | | | | | | 530,763 | | |
Other liabilities
|
| | | | 482,433 | | | | | | 1,010 | | |
Net cash used in operating activities
|
| | | | (45,482,672 ) | | | | | | (27,476,200 ) | | |
INVESTING ACTIVITIES | | | | ||||||||||
Purchase of property and equipment
|
| | | | (1,098,180 ) | | | | | | (8,804,244 ) | | |
Net cash used in investing activities
|
| | | | (1,098,180 ) | | | | | | (8,804,244 ) | | |
FINANCING ACTIVITIES | | | | ||||||||||
Repurchase of Series A redeemable preferred stock
|
| | | | — | | | | | | (226,001 ) | | |
Proceeds from the sale of common stock, net of offering costs
|
| | | | 16,137,913 | | | | | | 41,249,998 | | |
Proceeds from sale of common stock units in connection with initial public offering and private placement
|
| | | | 37,074,996 | | | | | | — | | |
Payment of offering costs and common stock issuance costs
|
| | | | (4,637,647 ) | | | | | | — | | |
Proceeds from subscriptions receivable
|
| | | | 4,280,149 | | | | | | — | | |
Proceeds from the sale of equity in noncontrolling interest
|
| | | | — | | | | | | 401,000 | | |
Proceeds from stockholders notes
|
| | | | — | | | | | | 10,880,252 | | |
Payments of capital leases obligations
|
| | | | (884,620 ) | | | | | | (686,676 ) | | |
Proceeds from debt
|
| | | | 200,416 | | | | | | — | | |
Repayment of debt
|
| | | | (1,059,034 ) | | | | | | (725,598 ) | | |
Repayment of stockholder notes
|
| | | | (11,601,696 ) | | | | | | (7,888,658 ) | | |
Change in restricted cash
|
| | | | (2,423 ) | | | | | | (2,211 ) | | |
Proceeds from Sonnet Biotherapeutics, Inc.
|
| | | | 826,561 | | | | | | — | | |
Deconsolidation of Sonnet Biotherapeutics, Inc.
|
| | | | (401,091 ) | | | | | | — | | |
Payment of employee tax withholdings related to the vesting of restricted stock
|
| | | | (71,760 ) | | | | | | — | | |
Net cash provided by financing activities
|
| | | | 39,861,764 | | | | | | 43,002,106 | | |
Net (decrease) increase in cash
|
| | | | (6,719,088 ) | | | | | | 6,721,662 | | |
Cash at beginning of year
|
| | | | 9,070,975 | | | | | | 2,349,313 | | |
Cash at end of year
|
| | | $ | 2,351,887 | | | | | $ | 9,070,975 | | |
Supplemental disclosure of cash flow information | | | | ||||||||||
Cash paid for interest
|
| | | $ | 1,477,913 | | | | | $ | 1,402,209 | | |
Cash paid for income taxes
|
| | | $ | 3,000 | | | | | $ | 2,250 | | |
Supplemental schedule of noncash investing activities: | | | | ||||||||||
Purchases of property and equipment in accounts payable and accrued expenses
|
| | | $ | 634,941 | | | | | $ | (2,770,730 ) | | |
Supplemental schedule of noncash financing activities: | | | | ||||||||||
Accretion of redeemable preferred stock, common stock and noncontrolling interests
|
| | | $ | 2,463,160 | | | | | $ | 4,306,488 | | |
Deemed dividend upon repurchase of Series A redeemable preferred stock in excess of carrying value
|
| | | $ | — | | | | | $ | (1,298,631 ) | | |
Issuance of subscription receivable upon sale of common stock
|
| | | $ | — | | | | | $ | (4,280,149 ) | | |
Issuance of common and Series A preferred stock to redeemable preferred stockholders and
noncontrolling interests upon reincorporation |
| | | $ | 11,894,638 | | | | | $ | — | | |
Reclassification of equity classified stock-based compensation
|
| | | $ | 15,118,584 | | | | | $ | — | | |
Distribution of common stock in Sonnet Biotherapeutics, Inc. to stockholders
|
| | | $ | — | | | | | $ | (221,154 ) | | |
Issuance of capital lease obligations in connection with purchase of property and equipment
|
| | | $ | 100,383 | | | | | $ | 2,603,894 | | |
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses
|
| | | $ | 3,144 | | | | | $ | 2,310,961 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Series A redeemable preferred stock
|
| | | | — | | | | | | 1,034,181 | | |
Series B redeemable preferred stock
|
| | | | — | | | | | | 1,159,418 | | |
Performance-based stock units
|
| | | | 247,309 | | | | | | — | | |
Restricted stock units
|
| | | | 1,094,351 | | | | | | — | | |
Convertible stockholder note
|
| | | | — | | | | | | 96,618 | | |
Common stock warrants
|
| | | | 8,186,934 | | | | | | — | | |
| | |
September 30, 2015
|
| |||||||||||||||
| | |
(Level 1)
|
| |
(Level 2)
|
| |
(Level 3)
|
| |||||||||
Liabilities | | | | | |||||||||||||||
Stock-based compensation liability
|
| | | $ | — | | | | | $ | — | | | | | $ | 12,726,722 | | |
|
Balance at October 1, 2014
|
| | | $ | 1,557,789 | | |
|
Change in fair value
|
| | | | 11,168,933 | | |
|
Balance at September 30, 2015
|
| | | | 12,726,722 | | |
|
Change in fair value
|
| | | | 2,391,862 | | |
|
Reclassification to stockholders’ equity (deficit)
|
| | | | (15,118,584 ) | | |
|
Balance at September 30, 2016
|
| | | $ | — | | |
|
| | |
September 30, 2015
|
|
Risk-free interest rate
|
| |
1.4%
|
|
Derived service period
|
| |
5 years
|
|
Expected volatility
|
| |
60%
|
|
Annual dividend yield
|
| |
0%
|
|
Fair value of common stock
|
| |
$25.79 per share
|
|
| | |
September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Laboratory equipment
|
| | | $ | 11,452,858 | | | | | $ | 10,936,364 | | |
Leasehold improvements
|
| | | | 10,031,739 | | | | | | 9,889,521 | | |
Computer software and hardware
|
| | | | 421,206 | | | | | | 402,075 | | |
Construction in progress
|
| | | | 1,014,690 | | | | | | 175,425 | | |
| | | | | 22,920,493 | | | | | | 21,403,385 | | |
Less: accumulated depreciation and amortization
|
| | | | (5,961,940 ) | | | | | | (3,643,447 ) | | |
| | | | $ | 16,958,553 | | | | | $ | 17,759,938 | | |
|
|
2017
|
| | | $ | 1,093,624 | | |
|
2018
|
| | | | 341,740 | | |
| | | | | | 1,435,364 | | |
|
Less: amounts representing interest
|
| | | | (137,379 ) | | |
|
Less: current portion
|
| | | | (977,248 ) | | |
|
Capital lease obligations, excluding current portion
|
| | | $ | 320,737 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Compensation
|
| | | $ | 3,884,386 | | | | | $ | 2,321,508 | | |
Research and development
|
| | | | 1,343,910 | | | | | | 951,759 | | |
Interest payable
|
| | | | 234,754 | | | | | | 806,475 | | |
Deferred offering costs
|
| | | | 26,028 | | | | | | 657,892 | | |
Professional fees
|
| | | | 486,705 | | | | | | 594,572 | | |
Director fees
|
| | | | 73,125 | | | | | | 414,421 | | |
Other accrued expenses
|
| | | | 73,034 | | | | | | 178,021 | | |
| | | | $ | 6,121,942 | | | | | $ | 5,924,648 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Series A repurchase notes
|
| | | $ | — | | | | | $ | 800,534 | | |
Parilis Series A repurchase notes
|
| | | | — | | | | | | 2,275,818 | | |
Restricted stock repurchase notes
|
| | | | 800,000 | | | | | | 1,097,750 | | |
Common stock repurchase note
|
| | | | 2,812,500 | | | | | | 2,812,500 | | |
Convertible note
|
| | | | — | | | | | | 2,000,000 | | |
Working capital notes
|
| | | | 1,000,000 | | | | | | 7,227,594 | | |
| | | | | 4,612,500 | | | | | | 16,214,196 | | |
Less: current portion
|
| | | | (4,612,500 ) | | | | | | (14,214,196 ) | | |
| | | | $ | — | | | | | $ | 2,000,000 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Term loans – Bank
|
| | | $ | 2,526,502 | | | | | $ | 3,404,759 | | |
Equipment loans
|
| | | | 354,979 | | | | | | 334,093 | | |
Unamortized debt discount
|
| | | | (61,224 ) | | | | | | (73,442 ) | | |
| | | | | 2,820,257 | | | | | | 3,665,410 | | |
Less: current portion
|
| | | | (586,454 ) | | | | | | (742,646 ) | | |
Long-term debt
|
| | | $ | 2,233,803 | | | | | $ | 2,922,764 | | |
|
|
2017
|
| | | $ | 586,454 | | |
|
2018
|
| | | | 515,793 | | |
|
2019
|
| | | | 549,694 | | |
|
2020
|
| | | | 569,142 | | |
|
2021
|
| | | | 497,491 | | |
|
Thereafter
|
| | | | 162,907 | | |
| | | | | $ | 2,881,481 | | |
|
|
2017
|
| | | $ | 1,551,513 | | |
|
2018
|
| | | | 1,735,263 | | |
|
2019
|
| | | | 1,753,323 | | |
|
2020
|
| | | | 1,771,545 | | |
|
2021
|
| | | | 1,596,976 | | |
|
Thereafter
|
| | | | 3,541,990 | | |
| | | | | $ | 11,950,610 | | |
|
| | |
Year ended September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Research and development
|
| | | $ | 2,044,379 | | | | | $ | 5,817,830 | | |
General and administrative
|
| | | | 10,405,700 | | | | | | 5,360,028 | | |
| | | | $ | 12,450,079 | | | | | $ | 11,177,858 | | |
|
| | |
Year ended September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Equity-classified compensation
|
| | | $ | 10,058,217 | | | | | $ | 8,925 | | |
Liability-classified compensation
|
| | | | 2,391,862 | | | | | | 11,168,933 | | |
| | | | $ | 12,450,079 | | | | | $ | 11,177,858 | | |
|
| | |
Number of
PSUs |
| |
Base Price
Per PSU |
| ||||||
Balance at October 1, 2014
|
| | | | 658,498 | | | | | $ | 3.45 | | |
Granted
|
| | | | 39,988 | | | | | | 3.45 | | |
Forfeitures
|
| | | | (11,473 ) | | | | | | 3.45 | | |
Balance at October 1, 2015
|
| | | | 687,013 | | | | | | 3.45 | | |
Forfeitures
|
| | | | (4,924 ) | | | | | | 4.85 | | |
Exchanged for restricted stock units
|
| | | | (434,780 ) | | | | | | 3.45 | | |
Balance at September 30, 2016
|
| | | | 247,309 | | | | | $ | 6.33 | | |
|
| | |
December 31, 2015
|
|
Risk-free interest rate
|
| |
1.0%
|
|
Derived service period
|
| |
2.3 years
|
|
Expected volatility
|
| |
57.6%
|
|
Annual dividend yield
|
| |
0%
|
|
Fair value of common stock
|
| |
$29.05 per share
|
|
| | |
Number of
RSUs |
| |
Weighted
Average Grant Date Fair Value |
| ||||||
Balance at October 1, 2015
|
| | | | — | | | | | $ | — | | |
Granted
|
| | | | 705,311 | | | | | | 28.31 | | |
Forfeitures
|
| | | | (2,263 ) | | | | | | 13.78 | | |
Issued in connection with PSU exchange
|
| | | | 391,303 | | | | | | 29.05 | | |
Balance at September 30, 2016
|
| | | | 1,094,351 | | | | | $ | 28.61 | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
State tax, including sale of New Jersey losses and credits
|
| | | $ | 3,000 | | | | | $ | (725,969 ) | | |
Foreign tax provision
|
| | | | 100,000 | | | | | | 535,858 | | |
| | | | $ | 103,000 | | | | | $ | (190,111 ) | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
U.S. federal statutory rate
|
| | | | (34.0 )% | | | | | | (34.0 )% | | |
State taxes, net of federal benefit
|
| | | | (5.9 ) | | | | | | (5.5 ) | | |
Foreign withholding tax
|
| | | | 0.2 | | | | | | 1.1 | | |
Permanent differences
|
| | | | — | | | | | | 1.8 | | |
Foreign tax credits
|
| | | | — | | | | | | (1.1 ) | | |
Research and development credit
|
| | | | — | | | | | | (6.9 ) | | |
Change in valuation allowance
|
| | | | 40.0 | | | | | | 44.6 | | |
Other
|
| | | | (0.1 ) | | | | | | (0.4 ) | | |
Effective income tax rate
|
| | | | 0.2 % | | | | | | (0.4 )% | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Deferred tax assets | | | | ||||||||||
Net operating loss carryforwards
|
| | | $ | 36,146,789 | | | | | $ | 20,164,392 | | |
Stock compensation
|
| | | | 11,249,314 | | | | | | 6,317,492 | | |
Deferred revenue
|
| | | | 2,542,558 | | | | | | 3,333,201 | | |
Research and development credit carryforward
|
| | | | 757,701 | | | | | | 5,979,964 | | |
Foreign tax credits
|
| | | | 2,257,309 | | | | | | 2,602,949 | | |
Accruals and others
|
| | | | 1,287,592 | | | | | | 1,072,422 | | |
Gross deferred tax assets
|
| | | | 54,241,263 | | | | | | 39,470,420 | | |
Less: valuation allowance
|
| | | | (52,737,104 ) | | | | | | (38,694,795 ) | | |
| | | | | 1,504,159 | | | | | | 775,625 | | |
Deferred tax liability: | | | | ||||||||||
Fixed assets
|
| | | | (1,504,159 ) | | | | | | (775,625 ) | | |
Net deferred tax assets
|
| | | $ | — | | | | | $ | — | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Balance at beginning of year
|
| | | $ | 1,754,629 | | | | | $ | 1,564,411 | | |
Additions based on tax positions related to the current year
|
| | | | 100,000 | | | | | | 190,218 | | |
Balance at end of year
|
| | | | 1,854,629 | | | | | | 1,754,629 | | |
|
| | |
December 31,
2016 |
| |
September 30,
2016 |
| ||||||
Assets | | | | ||||||||||
Current assets: | | | | ||||||||||
Cash
|
| | | $ | 2,078,535 | | | | | $ | 2,351,887 | | |
Prepaid and other current assets
|
| | | | 1,095,976 | | | | | | 3,326,607 | | |
Total current assets
|
| | | | 3,174,511 | | | | | | 5,678,494 | | |
Property and equipment, net
|
| | | | 16,440,919 | | | | | | 16,958,553 | | |
Restricted cash
|
| | | | — | | | | | | 216,086 | | |
Other assets
|
| | | | 830,887 | | | | | | 852,801 | | |
Total assets
|
| | | $ | 20,446,317 | | | | | $ | 23,705,934 | | |
Liabilities and stockholders’ equity (deficit) | | | | ||||||||||
Current liabilities: | | | | ||||||||||
Senior secured notes
|
| | | $ | 4,933,661 | | | | | $ | — | | |
Current portion of debt
|
| | | | 110,394 | | | | | | 586,454 | | |
Current portion of capital lease obligations
|
| | | | 1,014,563 | | | | | | 977,248 | | |
Current portion of stockholder notes
|
| | | | 4,612,500 | | | | | | 4,612,500 | | |
Accounts payable
|
| | | | 11,049,027 | | | | | | 5,071,520 | | |
Accrued expenses
|
| | | | 7,342,102 | | | | | | 6,121,942 | | |
Income taxes payable
|
| | | | 1,854,629 | | | | | | 1,854,629 | | |
Deferred revenue
|
| | | | 1,212,561 | | | | | | 1,212,561 | | |
Total current liabilities
|
| | | | 32,129,437 | | | | | | 20,436,854 | | |
Long-term debt
|
| | | | 191,236 | | | | | | 2,233,803 | | |
Capital lease obligations
|
| | | | 113,082 | | | | | | 320,737 | | |
Warrant liability
|
| | | | 4,128,727 | | | | | | — | | |
Deferred revenue
|
| | | | 4,850,244 | | | | | | 5,153,384 | | |
Other liabilities
|
| | | | 865,526 | | | | | | 761,334 | | |
Total liabilities
|
| | | | 42,278,252 | | | | | | 28,906,112 | | |
Stockholders’ equity (deficit): | | | | ||||||||||
Series A preferred stock, par value $0.01 per share: 10,000,000 shares authorized, no shares issued and outstanding
|
| | | | — | | | | | | — | | |
Common stock, par value $0.01 per share; 200,000,000 shares authorized; 23,588,031 and 22,802,778 shares issued and outstanding at December 31, 2016 and September 30, 2016, respectively
|
| | | | 235,881 | | | | | | 228,028 | | |
Additional paid-in capital
|
| | | | 144,424,554 | | | | | | 141,965,342 | | |
Accumulated deficit
|
| | | | (166,492,370 ) | | | | | | (147,393,548 ) | | |
Total stockholders’ equity (deficit)
|
| | | | (21,831,935 ) | | | | | | (5,200,178 ) | | |
Total liabilities and stockholders’ equity (deficit)
|
| | | $ | 20,446,317 | | | | | $ | 23,705,934 | | |
|
| | |
Three Months Ended December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Collaboration revenues
|
| | | $ | 303,140 | | | | | $ | 994,894 | | |
Operating expenses: | | | | ||||||||||
Research and development
|
| | | | 13,312,306 | | | | | | 12,733,976 | | |
General and administrative
|
| | | | 4,888,860 | | | | | | 4,674,155 | | |
| | | | | 18,201,166 | | | | | | 17,408,131 | | |
Loss from operations
|
| | | | (17,898,026 ) | | | | | | (16,413,237 ) | | |
Interest expense, net
|
| | | | 386,713 | | | | | | 398,975 | | |
Change in fair value of warrant liability
|
| | | | 810,083 | | | | | | — | | |
Loss before income taxes
|
| | | | (19,094,822 ) | | | | | | (16,812,212 ) | | |
Income tax expense
|
| | | | 4,000 | | | | | | 52,000 | | |
Net loss
|
| | | | (19,098,822 ) | | | | | | (16,864,212 ) | | |
Accretion of redeemable common stock
|
| | | | — | | | | | | (939,539 ) | | |
Net loss attributable to common stockholders
|
| | | $ | (19,098,822 ) | | | | | $ | (17,803,751 ) | | |
Per share information: | | | | ||||||||||
Net loss per share of common stock, basic and diluted
|
| | | $ | (0.82 ) | | | | | $ | (1.36 ) | | |
Weighted average shares outstanding, basic and diluted
|
| | | | 23,196,959 | | | | | | 13,061,557 | | |
|
| | |
Common Stock
|
| |
Additional
Paid-in Capital |
| |
Accumulated
Deficit |
| |
Total
Stockholders’ Equity (Deficit) |
| ||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| ||||||||||||||||||||||||
Balance at October 1, 2016
|
| | | | 22,802,778 | | | | | $ | 228,028 | | | | | $ | 141,965,342 | | | | | $ | (147,393,548 ) | | | | | $ | (5,200,178 ) | | |
Proceeds from exercise of common stock warrants
|
| | | | 301,340 | | | | | | 3,013 | | | | | | — | | | | | | — | | | | | | 3,013 | | |
Issuance of vested restricted stock units
|
| | | | 483,913 | | | | | | 4,840 | | | | | | (4,840 ) | | | | | | — | | | | | | — | | |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | 2,464,052 | | | | | | — | | | | | | 2,464,052 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | (19,098,822 ) | | | | | | (19,098,822 ) | | |
Balance at December 31, 2016
|
| | | | 23,588,031 | | | | | $ | 235,881 | | | | | $ | 144,424,554 | | | | | $ | (166,492,370 ) | | | | | $ | (21,831,935 ) | | |
|
| | |
Three Months Ended December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
OPERATING ACTIVITIES | | | | ||||||||||
Net loss
|
| | | $ | (19,098,822 ) | | | | | $ | (16,864,212 ) | | |
Adjustments to reconcile net loss to net cash used in operating activities:
|
| | | ||||||||||
Depreciation and amortization
|
| | | | 669,780 | | | | | | 593,977 | | |
Non-cash interest expense
|
| | | | 140,820 | | | | | | 3,065 | | |
Stock-based compensation
|
| | | | 2,464,052 | | | | | | 2,490,034 | | |
Change in fair value of warrant liability
|
| | | | 810,083 | | | | | | — | | |
Changes in operating assets and liabilities:
|
| | | ||||||||||
Accounts receivable
|
| | | | — | | | | | | (83,090 ) | | |
Prepaid expenses and other current assets
|
| | | | 2,230,631 | | | | | | 142,073 | | |
Other assets
|
| | | | 21,914 | | | | | | 5,433 | | |
Accounts payable
|
| | | | 5,898,662 | | | | | | (233,942 ) | | |
Accrued expenses
|
| | | | 1,220,160 | | | | | | 2,203,188 | | |
Income taxes payable
|
| | | | — | | | | | | 50,000 | | |
Deferred revenue
|
| | | | (303,140 ) | | | | | | (494,894 ) | | |
Other liabilities
|
| | | | 104,192 | | | | | | 176,087 | | |
Net cash used in operating activities
|
| | | | (5,841,668 ) | | | | | | (12,012,281 ) | | |
INVESTING ACTIVITIES | | | | ||||||||||
Purchase of property and equipment
|
| | | | (148,362 ) | | | | | | (364,242 ) | | |
Net cash used in investing activities
|
| | | | (148,362 ) | | | | | | (364,242 ) | | |
FINANCING ACTIVITIES | | | | ||||||||||
Proceeds from the sale of common stock, net of offering costs
|
| | | | — | | | | | | 11,318,690 | | |
Payment of debt issuance costs
|
| | | | (40,000 ) | | | | | | — | | |
Proceeds from subscriptions receivable
|
| | | | — | | | | | | 4,280,149 | | |
Proceeds from future stock issuance
|
| | | | — | | | | | | 50,520 | | |
Proceeds from exercise of common stock warrants
|
| | | | 3,013 | | | | | | — | | |
Proceeds from the sale of senior secured notes and detachable warrants
|
| | | | 8,350,000 | | | | | | — | | |
Payments of capital leases obligations
|
| | | | (232,570 ) | | | | | | (222,652 ) | | |
Repayment of debt
|
| | | | (2,579,851 ) | | | | | | (180,058 ) | | |
Repayment of stockholder notes
|
| | | | — | | | | | | (6,073,383 ) | | |
Change in restricted cash
|
| | | | 216,086 | | | | | | — | | |
Proceeds from related party receivable
|
| | | | — | | | | | | 187,388 | | |
Deconsolidation of Sonnet Biotherapeutics, Inc.
|
| | | | — | | | | | | (401,091 ) | | |
Payment of employee tax witholdings related to the vesting of restricted stock
|
| | | | — | | | | | | (71,760 ) | | |
Net cash provided by financing activities
|
| | | | 5,716,678 | | | | | | 8,887,803 | | |
Net decrease in cash
|
| | | | (273,352 ) | | | | | | (3,488,720 ) | | |
Cash at beginning of period
|
| | | | 2,351,887 | | | | | | 9,070,975 | | |
Cash at end of period
|
| | | $ | 2,078,535 | | | | | $ | 5,582,255 | | |
Supplemental disclosure of cash flow information
|
| | | ||||||||||
Cash paid for interest
|
| | | $ | 221,266 | | | | | $ | 407,403 | | |
Cash paid for income taxes
|
| | | $ | — | | | | | $ | 2,000 | | |
Supplemental schedule of noncash investing activities: | | | | ||||||||||
Purchases of property and equipment in accounts payable and accrued expenses
|
| | | $ | (20,711 ) | | | | | $ | (200,780 ) | | |
Supplemental schedule of noncash financing activities: | | | | ||||||||||
Accretion of redeemable common stock
|
| | | $ | — | | | | | $ | 939,539 | | |
Issuance of common and Series A preferred stock to redeemable preferred stockholders and noncontrolling interests upon reincorporation
|
| | | $ | — | | | | | $ | (11,894,638 ) | | |
Reclassification of equity classified stock-based compensation
|
| | | $ | — | | | | | $ | (15,118,584 ) | | |
Issuance of subscription receivable upon sale of common stock
|
| | | $ | — | | | | | $ | (2,749,997 ) | | |
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses
|
| | | $ | (137,291 ) | | | | | $ | (1,014,281 ) | | |
|
| | |
December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Series A preferred stock
|
| | | | — | | | | | | 1,969,818 | | |
Performance-based stock units
|
| | | | 243,774 | | | | | | 249,510 | | |
Restricted stock units
|
| | | | 1,224,957 | | | | | | 1,066,193 | | |
Convertible stockholder note
|
| | | | — | | | | | | 96,618 | | |
Common stock warrants
|
| | | | 9,806,028 | | | | | | — | | |
| | |
December 31, 2016
|
| |||||||||||||||
| | |
(Level 1)
|
| |
(Level 2)
|
| |
(Level 3)
|
| |||||||||
Liabilities | | | | | |||||||||||||||
Warrant liability
|
| | | $ | — | | | | | $ | — | | | | | $ | 4,128,727 | | |
|
Balance at October 1, 2016
|
| | | $ | — | | |
|
Issuance of warrants
|
| | | | 3,318,644 | | |
|
Change in fair value
|
| | | | 810,083 | | |
|
Balance at December 31, 2016
|
| | | $ | 4,128,727 | | |
|
| | |
December 31,
2016 |
|
Risk-free interest rate
|
| |
1.93%
|
|
Remaining contractual life of warrant
|
| |
5 years
|
|
Expected volatility
|
| |
93%
|
|
Annual dividend yield
|
| |
0%
|
|
Fair value of common stock
|
| |
$3.01 per share
|
|
| | |
December 31,
2016 |
| |
September 30,
2016 |
| ||||||
Laboratory equipment
|
| | | $ | 11,486,716 | | | | | $ | 11,452,858 | | |
Leasehold improvements
|
| | | | 10,031,739 | | | | | | 10,031,739 | | |
Computer software and hardware
|
| | | | 471,152 | | | | | | 421,206 | | |
Construction in progress
|
| | | | 1,083,032 | | | | | | 1,014,690 | | |
| | | | | 23,072,639 | | | | | | 22,920,493 | | |
Less: accumulated depreciation and amortization
|
| | | | (6,631,720 ) | | | | | | (5,961,940 ) | | |
| | | | $ | 16,440,919 | | | | | $ | 16,958,553 | | |
|
| | |
December 31,
2016 |
| |
September 30,
2016 |
| ||||||
Compensation
|
| | | $ | 3,786,902 | | | | | $ | 3,884,386 | | |
Research and development
|
| | | | 1,991,612 | | | | | | 1,343,910 | | |
Interest payable
|
| | | | 345,087 | | | | | | 234,754 | | |
Deferred offering costs
|
| | | | — | | | | | | 26,028 | | |
Professional fees
|
| | | | 582,731 | | | | | | 486,705 | | |
Director fees
|
| | | | 146,250 | | | | | | 73,125 | | |
Other accrued expenses
|
| | | | 489,520 | | | | | | 73,034 | | |
| | | | $ | 7,342,102 | | | | | $ | 6,121,942 | | |
|
| | |
December 31,
2016 |
| |||
Senior secured notes
|
| | | $ | 8,350,000 | | |
Unamortized debt discount
|
| | | | (3,416,339 ) | | |
| | | | $ | 4,933,661 | | |
|
| | |
Outstanding
|
| |
Exercise
price per share |
| |
Expiration date
|
| ||||||
Series A warrants
|
| | | | 3,333,333 | | | | | $ | 6.60 | | | |
February 18, 2018
|
|
Series B warrants
|
| | | | 3,333,333 | | | | | $ | 8.50 | | | |
May 18, 2018
|
|
Common stock warrants issued with IPO
|
| | | | 1,218,862 | | | | | $ | 0.01 | | | |
November 11, 2019
|
|
Common stock warrants issued with senior secured notes
|
| | | | 1,920,500 | | | | | $ | 3.00 | | | |
December 22, 2021
|
|
| | | | | 9,806,028 | | | | | |||||||
|
| | |
Three months ended December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Research and development
|
| | | $ | 386,109 | | | | | $ | 1,356,408 | | |
General and administrative
|
| | | | 2,077,943 | | | | | | 1,133,626 | | |
| | | | $ | 2,464,052 | | | | | $ | 2,490,034 | | |
|
| | |
Three months ended December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Equity-classified compensation
|
| | | $ | 2,464,052 | | | | | $ | 98,172 | | |
Liability-classified compensation
|
| | | | — | | | | | | 2,391,862 | | |
| | | | $ | 2,464,052 | | | | | $ | 2,490,034 | | |
|
| | |
Number of
PSUs |
| |
Base Price
Per PSU |
| ||||||
Balance at October 1, 2016
|
| | | | 247,309 | | | | | $ | 6.33 | | |
Forfeitures
|
| | | | (3,535 ) | | | | | | 7.40 | | |
Balance at December 31, 2016
|
| | | | 243,774 | | | | | $ | 6.35 | | |
|
| | |
Number of
RSUs |
| |
Weighted
Average Grant Date Fair Value |
| ||||||
Balance at October 1, 2016
|
| | | | 1,094,351 | | | | | $ | 28.61 | | |
Granted
|
| | | | 615,000 | | | | | | 2.11 | | |
Vested and settled
|
| | | | (483,913 ) | | | | | | 29.05 | | |
Forfeitures
|
| | | | (481 ) | | | | | | 29.05 | | |
Balance at December 31, 2016
|
| | | | 1,224,957 | | | | | $ | 15.13 | | |
|
Item
|
| |
Amount to
be paid |
| |||
SEC filing fee
|
| | | $ | 1,607 | | |
Legal fees and expenses
|
| | | | 75,000 | | |
Accounting fees and expenses
|
| | | | 12,500 | | |
Printing and miscellaneous expenses
|
| | | | 25,893 | | |
Total
|
| | | $ | 115,000 | | |
|
| | | | ONCOBIOLOGICS, INC. | | |||
| | | | By: | | | /s/ Pankaj Mohan | |
| | | | | | | Pankaj Mohan, Ph.D. | |
| | | | | | | Chairman, President and Chief Executive Officer | |
|
Signature
|
| |
Title
|
| |
Date
|
|
|
/s/ Pankaj Mohan
Pankaj Mohan, Ph.D.
|
| |
Chairman, President and Chief Executive Officer
(Principal Executive Officer) |
| |
March 10, 2017
|
|
|
/s/ Lawrence A. Kenyon
Lawrence A. Kenyon
|
| |
Chief Financial Officer
(Principal Accounting and Financial Officer) |
| |
March 10, 2017
|
|
|
/s/ Todd C. Brady
Todd C. Brady, M.D., Ph.D.
|
| |
Director
|
| |
March 10, 2017
|
|
|
/s/ Scott Canute
Scott Canute
|
| |
Director
|
| |
March 10, 2017
|
|
|
/s/ Albert D. Dyrness
Albert D. Dyrness
|
| |
Director
|
| |
March 10, 2017
|
|
|
/s/ Donald J. Griffith
Donald J. Griffith
|
| |
Director
|
| |
March 10, 2017
|
|
|
/s/ Kurt J. Hilzinger
Kurt J. Hilzinger
|
| |
Director
|
| |
March 10, 2017
|
|
|
/s/ Robin Smith Hoke
Robin Smith Hoke
|
| |
Director
|
| |
March 10, 2017
|
|
Exhibit
Number |
| |
Description
|
|
3.1 | | | Amended and Restated Certificate of Incorporation of Oncobiologics, Inc. (incorporated by reference to Exhibit 3.1 to the Registrant’s current report on Form 8-K filed on May 19, 2016). | |
3.2 | | | Amended and Restated Bylaws of Oncobiologics, Inc. (incorporated by reference to Exhibit 3.2 to the Registrant’s current report on Form 8-K filed on May 19, 2016). | |
3.3 | | | Amendment to the Amended and Restated Bylaws of Oncobiologics, Inc. (incorporated by reference to Exhibit 3.1 to the Registrant’s current report on Form 8-K filed with the SEC on November 29, 2016). | |
5.1 | | | Opinion of Cooley LLP. | |
10.1 | | | Investors’ Rights Agreement by and among Oncobiologics, Inc. and certain of its stockholders, dated March 10, 2014, as amended (incorporated by reference to Exhibit 10.1 to the Registrant’s registration statement on Form S-1 filed on May 11, 2016). | |
10.2 | | | 2011 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.3 | | | Form of Amended and Restated Performance Stock Unit Agreement for 2011 Stock Incentive Plan (incorporated by reference to Exhibit 10.29 to the Registrant’s registration statement on Form S-1 filed on April 27, 2016). | |
10.4 | | | 2015 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.5 | | | Forms of agreements and award grant notices for 2015 Equity Incentive Plan (incorporated by reference to Exhibit 10.4 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.6 | | | 2016 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.5 to the Registrant’s registration statement on Form S-1 filed on February 12, 2016). | |
10.7 | | | Form of Indemnity Agreement, by and between Oncobiologics, Inc. and each of its directors and executive officers (incorporated by reference to Exhibit 10.12 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.8† | | | Research License Agreement by and between Oncobiologics, Inc. and Selexis SA, effective as of October 3, 2011, as amended by Amendment No. 1 dated as of October 9, 2014 (incorporated by reference to Exhibit 10.13 to the Registrant’s registration statement on Form S-1 filed on February 26, 2016). | |
10.9† | | | ONS-3010 Commercial License Agreement by and between Oncobiologics, Inc. and Selexis SA effective as of April 11, 2013, as amended effective as of May 21, 2014 (incorporated by reference to Exhibit 10.14 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.10† | | | ONS-1045 Commercial License Agreement by and between Oncobiologics, Inc. and Selexis SA effective as of April 11, 2013, as amended effective as of May 21, 2014 (incorporated by reference to Exhibit 10.15 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.11† | | | ONS-1050 Commercial License Agreement by and between Oncobiologics, Inc. and Selexis SA effective as of April 11, 2013, as amended effective as of May 21, 2014 (incorporated by reference to Exhibit 10.16 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.12 | | | Joint Participation Agreement by and between Oncobiologics, Inc. and Zhejiang Huahai Pharmaceutical Co., Ltd., effective as of May 6, 2013, as amended by that Amendment No. 1 and Mutual Termination Agreement re: Joint Participation Agreement, dated December 23, 2014 (incorporated by reference to Exhibit 10.17 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.13 | | | Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of March 18, 2011 (incorporated by reference to Exhibit 10.18 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.14 | | | First Amendment to Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of December 2013 (incorporated by reference to Exhibit 10.19 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.15 | | | Second Amendment to Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of July 18, 2014 (incorporated by reference to Exhibit 10.20 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.16 | | | Third Amendment to Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of January 16, 2015 (incorporated by reference to Exhibit 10.21 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.17 | | | Fourth Amendment to Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of February 9, 2015 (incorporated by reference to Exhibit 10.22 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
Exhibit
Number |
| |
Description
|
|
10.18 | | | Fifth Amendment to Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of September 26, 2015 (incorporated by reference to Exhibit 10.23 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.19 | | | Lease Agreement by and between Cedar Brook East Corporate Center, LP and Oncobiologics, Inc., dated as of August 31, 2015 (incorporated by reference to Exhibit 10.24 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.20 | | | Employment Agreement between Oncobiologics, Inc. and Pankaj Mohan, Ph.D., dated February 22, 2016 (incorporated by reference to Exhibit 10.25 to the Registrant’s registration statement on Form S-1 filed on April 27, 2016). | |
10.21 | | | Employment Agreement between Oncobiologics, Inc. and Lawrence A. Kenyon, dated February 18, 2016 (incorporated by reference to Exhibit 10.28 to the Registrant’s registration statement on Form S-1 filed on April 27, 2016). | |
10.22 | | | Employment Agreement between Oncobiologics, Inc. and Kogan Bao, Ph.D., dated February 22, 2016 (incorporated by reference to Exhibit 10.22 to the Registrant’s registration statement on Form S-1 (File No. 333-209011) filed on January 4, 2017). | |
10.23 | | | Form of Warrant to Purchase Common Stock (incorporated by reference to Exhibit 10.30 to the Registrant’s registration statement on Form S-1 filed on May 11, 2016). | |
10.24 | | | Securities Purchase Agreement between Oncobiologics, Inc. and Sabby Healthcare Master Fund Ltd., dated May 11, 2016 (incorporated by reference to Exhibit 10.1 to the Registrant’s current report on Form 8-K filed on May 19, 2016). | |
10.25 | | | Warrant Agreement by and between Oncobiologics, Inc. and American Stock Transfer & Trust Company LLC, as Warrant Agent dated May 18, 2016 (incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q filed on June 27, 2016). | |
10.26 | | | Amendment to the Warrant Agreement, dated May 18, 2016, by and between Oncobiologics, Inc. and American Stock Transfer & Trust Company LLC, as Warrant Agent, dated February 6, 2017 (incorporated by reference to Exhibit 10.1 to the Registrant’s current report on Form 8-K filed with the SEC on February 6, 2017). | |
10.27 | | | Form of Series A warrant certificate (included in Exhibit 10.25). | |
10.28 | | | Form of Series B warrant certificate (included in Exhibit 10.25). | |
10.29 | | | Note and Warrant Purchase Agreement by and between Oncobiologics, Inc. and the Purchasers named therein dated December 22, 2016 (incorporated by reference to Exhibit 10.1 to the Registrant’s current report on Form 8-K filed with the SEC on December 23, 2016). | |
10.30 | | | Form of Senior Secured Promissory Note (included as Exhibit A to the Note and Warrant Purchase Agreement filed as Exhibit 10.28). | |
10.31 | | | Form of Warrant (included as Exhibit B to the Note Purchase Agreement filed as Exhibit 10.28). | |
10.32 | | | Security Agreement by and between Oncobiologics, Inc. and the Secured Parties named therein dated December 22, 2016 (incorporated by reference to Exhibit 10.4 to the Registrant’s current report on Form 8-K filed with the SEC on December 23, 2016). | |
10.33 | | | Intellectual Property Security Agreement by and between Oncobiologics, Inc. and the Secured Parties named therein dated December 22, 2016 (incorporated by reference to Exhibit 10.5 to the Registrant’s current report on Form 8-K filed with the SEC on December 23, 2016). | |
10.34 | | | Registration Rights Agreement by and between Oncobiologics, Inc. and the Investors named therein dated February 3, 2017 (incorporated by reference to Exhibit 10.1 to the Registrant’s current report on Form 8-K filed with the SEC on February 3, 2017). | |
10.35 | | | Purchase Agreement between Oncobiologics, Inc. and Lincoln Park Capital Fund, LLC, dated March 8, 2017 (incorporated by reference to Exhibit 10.1 to the Registrant’s current report on Form 8-K filed with the SEC on March 9, 2017). | |
10.36 | | | Registration Rights Agreement between Oncobiologics, Inc. and Lincoln Park Capital Fund, LLC, dated March 8, 2017 (incorporated by reference to Exhibit 10.2 to the Registrant’s current report on Form 8-K filed with the SEC on March 9, 2017). | |
23.1 | | | Consent of independent registered public accounting firm. | |
23.2 | | | Consent of Cooley LLP (included in Exhibit 5.1). | |
24.1 | | | Power of Attorney (included on signature page). | |
101.INS | | | XBRL Instance Document | |
101.SCH | | | XBRL Taxonomy Extension Schema Document | |
101.CAL | | | XBRL Taxonomy Extension Calculation Linkbase Document | |
Exhibit
Number |
| |
Description
|
|
101.DEF | | | XBRL Definition Linkbase Document | |
101.LAB | | | XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE | | | XBRL Taxonomy Extension Presentation Linkbase Document | |
Exhibit 5.1
Yvan-Claude Pierre
+1 212 479 6721
ypierre@cooley.com
March 10, 2017
Oncobiologics, Inc.
7 Clarke Drive
Cranbury, New Jersey 08512
Ladies and Gentlemen:
You have requested our opinion with respect to certain matters in connection with the filing by Oncobiologics, Inc., a Delaware corporation (the “ Company ”), of a Registration Statement on Form S-1 (the “ Registration Statement ”) with the Securities and Exchange Commission, including a related prospectus filed with the Registration Statement (the “ Prospectus ”), covering the registration for offer and resale of up to 5,114,747 shares of common stock, par value $0.01 per share (the “ Common Stock ”) by the selling stockholder (the “ Selling Stockholder ”) identified in the Registration Statement. The Registration Statement is to register the resale of (i) 150,376 shares of Common Stock (the “ Initial Purchase Shares ”) issued to the Selling Stockholder by the Company prior to the date hereof, (ii) 113,205 shares of Common Stock (the “ Initial Commitment Shares ”) issued to the Selling Stockholder by the Company prior to the date hereof, (iii) up to 113,206 shares of Common Stock (the “ Additional Commitment Shares ”) that may be issued to the Selling Stockholder from time to time by the Company pursuant to a Purchase Agreement dated March 8, 2017 between the Selling Stockholder and the Company (the “ Purchase Agreement ”) and (iv) up to 4,737,960 additional shares of Common Stock (the “ Purchase Shares ”) that may be issued to the Selling Stockholder from time to time by the Company pursuant to the Purchase Agreement.
In connection with this opinion, we have examined and relied upon (a) the Registration Statement and the Prospectus, (b) the Company’s Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws, as amended, each as currently in effect, (c) the Purchase Agreement and (d) originals or copies certified to our satisfaction of such records, documents, certificates, memoranda and other instruments as in our judgment are necessary or appropriate to enable us to render the opinion expressed below. We have undertaken no independent verification with respect to such matters.
We have assumed the genuineness and authenticity of all documents submitted to us as originals, the conformity to originals of all documents submitted to us as copies thereof, the accuracy, completeness and authenticity of certificates of public officials and the due execution and delivery of all documents by persons other than the Company where due execution and delivery are prerequisites to the effectiveness thereof. As to certain factual matters, we have relied upon a certificate of an officer of the Company and have not sought independently to verify such matters. We have assumed (x) that, upon the issuance of the Additional Commitment Shares and the Purchase Shares, the total number of shares of Common Stock issued and outstanding and committed to be issued will not exceed the total number of shares of Common Stock that the Company is then authorized to issue under its certificate of incorporation as it is then in effect, (y) that the proceeds from the sale of each of the Additional Commitment Shares and the Purchase Shares will be equal to at least the par value of the Common Stock, and (z) that the Company’s Board of Directors or a duly authorized committee thereof has approved the specific issuance of the Purchase Shares.
Our opinion is limited to the matters stated herein, and no opinion is implied or may be inferred beyond the matters expressly stated. Our opinion is expressed only with respect to the General Corporation Law of the State of Delaware and is based on the law as in effect on the date hereof. We express no opinion as to
Cooley LLP 1114 Avenue of the Americas New
York, NY 10036
t: (212) 479-6000 f: (212) 479-6275 cooley.com
March 10, 2017
Page Two
whether the laws of any particular jurisdiction are applicable to the subject matter hereof. We are not rendering any opinion as to compliance with any federal or state antifraud law, rule or regulation relating to securities, or to the sale or issuance thereof.
On the basis of the foregoing, and in reliance thereon, we are of the opinion that (i) the Initial Purchase Shares and Initial Commitment Shares have been validly issued and are fully paid and nonassessable, (ii) the Additional Commitment Shares, when issued by the Company and duly registered on the books of the transfer agent and registrar therefor in the name or on behalf of the Selling Stockholder as provided in the Purchase Agreement, will be validly issued, fully paid and nonassessable and (iii) the Purchase Shares, when issued by the Company against payment therefore and duly registered on the books of the transfer agent and registrar therefor in the name or on behalf of the Selling Stockholder as provided in the Purchase Agreement, will be validly issued, fully paid and nonassessable.
We consent to the reference to our firm under the caption “Legal Matters” in the Prospectus included in the Registration Statement and to the filing of this opinion as an exhibit to the Registration Statement.
Sincerely,
Cooley LLP
By: | /s/ Yvan Claude-Pierre | |
Yvan-Claude Pierre |
Cooley LLP 1114 Avenue of the Americas New
York, NY 10036
t: (212) 479-6000 f: (212) 479-6275 cooley.com
EXHIBIT 23.1
Consent of Independent Registered Public Accounting Firm
The Board of Directors
Oncobiologics, Inc.:
We consent to the use of our report included herein and to the reference to our firm under the heading “Experts” in the prospectus. Our report dated December 29, 2016 contains an explanatory paragraph that states that Oncobiologics, Inc. has incurred recurring losses and negative cash flows from operations since inception and has an accumulated deficit at September 30, 2016 of $147.4 million and $4.6 million of indebtedness that is due on demand, which raises substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/ KPMG LLP
Philadelphia, Pennsylvania
March 10, 2017