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Delaware
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38-3982704
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, $0.01 par value per share
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The Nasdaq Capital Market
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Series A warrants to purchase Common Stock
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The Nasdaq Capital Market
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| Large accelerated filer ☐ | | | Accelerated filer ☐ | | | Non-accelerated filer ☐ | | | Smaller reporting company ☒ | |
| Emerging growth company ☒ | | | | |
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Page
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| | | | ii | ||
PART I | | | ||||
| | | | 1 | ||
| | | | 19 | ||
| | | | 59 | ||
| | | | 59 | ||
| | | | 59 | ||
| | | | 59 | ||
PART II | | | ||||
| | | | 60 | ||
| | | | 61 | ||
| | | | 62 | ||
| | | | 78 | ||
| | | | 79 | ||
| | | | 110 | ||
| | | | 110 | ||
| | | | 110 | ||
PART III | | | ||||
| | | | 111 | ||
| | | | 115 | ||
| | | | 122 | ||
| | | | 124 | ||
| | | | 131 | ||
PART IV | | | ||||
| | | | 132 | ||
| | | | 136 |
| | |
Year ended September 30,
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| | |
2018
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2017
|
| |
Change
|
| |||||||||
Collaboration revenues
|
| | | $ | 3,087,560 | | | | | $ | 3,811,519 | | | | | $ | (723,959) | | |
Operating expenses: | | | | | |||||||||||||||
Research and development
|
| | | | 18,504,035 | | | | | | 23,809,749 | | | | | | (5,305,714) | | |
General and administrative
|
| | | | 14,227,828 | | | | | | 15,882,033 | | | | | | (1,654,205) | | |
| | | | | 32,731,863 | | | | | | 39,691,782 | | | | | | (6,959,919) | | |
Loss from operations
|
| | | | (29,644,303) | | | | | | (35,880,263) | | | | | | 6,235,960 | | |
Interest expense, net
|
| | | | 3,891,250 | | | | | | 5,625,833 | | | | | | (1,734,583) | | |
Loss on extinguishment of debt
|
| | | | 1,252,353 | | | | | | — | | | | | | 1,252,353 | | |
Change in fair value of warrant liability
|
| | | | (1,047,729) | | | | | | (3,158,469) | | | | | | 2,110,740 | | |
Loss before income taxes
|
| | | | (33,740,177) | | | | | | (38,347,627) | | | | | | 4,607,450 | | |
Income tax (benefit) expense
|
| | | | (3,648,216) | | | | | | 501,500 | | | | | | (4,149,716) | | |
Net loss
|
| | | $ | (30,091,961) | | | | | $ | (38,849,127) | | | | | $ | 8,757,166 | | |
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| | |
Year ended September 30,
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| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
IPCA Collaboration
|
| | | $ | 261,072 | | | | | $ | 261,072 | | |
Liomont Collaboration
|
| | | | 236,641 | | | | | | 236,641 | | |
Huahai Collaboration
|
| | | | 714,848 | | | | | | 714,848 | | |
BioLexis | | | | | 1,874,999 | | | | | | 2,598,958 | | |
| | | | $ | 3,087,560 | | | | | $ | 3,811,519 | | |
|
| | |
Year ended September 30,
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| | |
2018
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| |
2017
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| ||||||
Milestone payments
|
| | | $ | — | | | | | $ | 2,500,000 | | |
Recognition of deferred revenues
|
| | | | 3,087,560 | | | | | | 1,311,519 | | |
| | | | $ | 3,087,560 | | | | | $ | 3,811,519 | | |
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Year ended September 30,
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| | |
2018
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2017
|
| ||||||
Preclinical and clinical development
|
| | | $ | 7,403,015 | | | | | $ | 9,674,633 | | |
Settlement of clinical development contract
|
| | | | (3,228,613) | | | | | | — | | |
Compensation and related benefits
|
| | | | 6,911,910 | | | | | | 7,460,814 | | |
Stock-based compensation
|
| | | | 19,450 | | | | | | 1,001,022 | | |
Other research and development
|
| | | | 7,398,273 | | | | | | 5,673,280 | | |
Total research and development expenses
|
| | | $ | 18,504,035 | | | | | $ | 23,809,749 | | |
|
| | |
Year ended September 30,
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| |||||||||
| | |
2018
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| |
2017
|
| ||||||
ONS-3010
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| | | $ | 573,518 | | | | | $ | 5,195,278 | | |
ONS-1045
|
| | | | 348,596 | | | | | | 2,931,414 | | |
ONS-5010 | | | | | 6,315,937 | | | | | | — | | |
Early-stage compounds
|
| | | | 164,964 | | | | | | 1,547,941 | | |
Settlement of clinical development contract
|
| | | | (3,228,613) | | | | | | — | | |
Personnel related and stock-based compensation
|
| | | | 6,931,360 | | | | | | 8,461,836 | | |
Other research and development
|
| | | | 7,398,273 | | | | | | 5,673,280 | | |
Total research and development expenses
|
| | | $ | 18,504,035 | | | | | $ | 23,809,749 | | |
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| | |
Year ended September 30,
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2018
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2017
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| ||||||
Professional fees
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| | | $ | 3,155,658 | | | | | $ | 3,263,523 | | |
Compensation and related benefits
|
| | | | 2,451,796 | | | | | | 2,695,751 | | |
Stock-based compensation
|
| | | | 1,966,420 | | | | | | 7,570,635 | | |
Facilities, fees and other related costs
|
| | | | 6,653,954 | | | | | | 2,352,123 | | |
Total general and administrative expenses
|
| | | $ | 14,227,828 | | | | | $ | 15,882,033 | | |
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| | |
Year ended September 30,
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| | |
2018
|
| |
2017
|
| ||||||
Net cash used in operating activities
|
| | | $ | (33,039,523) | | | | | $ | (15,505,054) | | |
Net cash used in investing activities
|
| | | | (2,781,125) | | | | | | (292,086) | | |
Net cash provided by financing activities
|
| | | | 34,352,520 | | | | | | 16,630,772 | | |
Net (decrease) increase in cash
|
| | | $ | (1,468,128) | | | | | $ | 833,632 | | |
|
| | |
Payments Due by Period
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Total
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Less Than 1
Year |
| |
1 – 3
Years |
| |
3 – 5
Years |
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More Than
5 Years |
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Operating lease commitments(1)
|
| | | $ | 562,500 | | | | | $ | 180,000 | | | | | $ | 382,500 | | | | | $ | — | | | | | $ | — | | |
Debt obligations(2)
|
| | | | 19,942,487 | | | | | | 15,587,149 | | | | | | 4,355,338 | | | | | | — | | | | | | — | | |
Capital leases(3)
|
| | | | 15,389,496 | | | | | | 1,947,199 | | | | | | 3,088,359 | | | | | | 3,073,538 | | | | | | 7,280,400 | | |
Lease termination obligation(4)
|
| | | | 5,275,750 | | | | | | 425,750 | | | | | | 4,850,000 | | | | | | — | | | | | | — | | |
Total(5)
|
| | | $ | 41,170,233 | | | | | $ | 18,140,098 | | | | | $ | 12,676,197 | | | | | $ | 3,073,538 | | | | | $ | 7,280,400 | | |
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Page
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| | | | 80 | | | |
| | | | 81 | | | |
| | | | 82 | | | |
| | | | 83 | | | |
| | | | 84 | | | |
| | | | 85 | | |
| | |
September 30,
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| | | |||||||||||||
| | |
2018
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2017
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Assets
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| | | | | | | ||||||||||||
Current assets: | | | | | | | | | | | | | | | | ||||
Cash
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| | | $ | 1,717,391 | | | | | $ | 3,185,519 | | | | | ||||
Prepaid and other current assets
|
| | | | 1,585,089 | | | | | | 719,087 | | | | | ||||
Total current assets
|
| | | | 3,302,480 | | | | | | 3,904,606 | | | | | ||||
Property and equipment, net
|
| | | | 18,489,976 | | | | | | 16,088,902 | | | | | ||||
Other assets
|
| | | | 491,039 | | | | | | 740,362 | | | | | ||||
Total assets
|
| | | $ | 22,283,495 | | | | | $ | 20,733,870 | | | | | ||||
Liabilities, convertible preferred stock and stockholders’ equity (deficit)
|
| | | | | | | ||||||||||||
Current liabilities: | | | | | | | | | | | | | | | | ||||
Senior secured notes
|
| | | $ | 13,179,449 | | | | | $ | — | | | | | ||||
Current portion of long-term debt
|
| | | | 66,480 | | | | | | 52,600 | | | | | ||||
Current portion of capital lease obligations
|
| | | | 520,794 | | | | | | 341,120 | | | | | ||||
Stockholder notes
|
| | | | 4,612,500 | | | | | | 4,612,500 | | | | | ||||
Accounts payable
|
| | | | 3,609,607 | | | | | | 10,954,358 | | | | | ||||
Accrued expenses
|
| | | | 6,458,471 | | | | | | 7,337,469 | | | | | ||||
Income taxes payable
|
| | | | 1,856,129 | | | | | | 2,352,129 | | | | | ||||
Deferred revenue
|
| | | | 1,738,603 | | | | | | 3,087,561 | | | | | ||||
Total current liabilities
|
| | | | 32,042,033 | | | | | | 28,737,737 | | | | | ||||
Senior secured notes
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| | | | — | | | | | | 13,231,700 | | | | | ||||
Long-term debt
|
| | | | 98,487 | | | | | | 151,110 | | | | | ||||
Capital lease obligations
|
| | | | 3,453,256 | | | | | | 28,067 | | | | | ||||
Warrant liability
|
| | | | 1,227,225 | | | | | | 2,274,954 | | | | | ||||
Deferred revenue
|
| | | | 2,758,262 | | | | | | 4,466,865 | | | | | ||||
Other liabilities
|
| | | | 3,514,738 | | | | | | 2,569,971 | | | | | ||||
Total liabilities
|
| | | | 43,094,001 | | | | | | 51,460,404 | | | | | ||||
Commitments (Note 9) | | | | | | | | | | | | | | | | ||||
Convertible preferred stock: | | | | | | | | | | | | | | | | ||||
Series A convertible preferred stock, par value $0.01 per share: 1,000,000 shares
authorized, no shares issued and outstanding at September 30, 2018 and 32,628 shares issued and outstanding at September 30, 2017 |
| | | | — | | | | | | 2,924,441 | | | | | ||||
Series A-1 convertible preferred stock, par value $100.00 per share: 200,000 shares authorized, 60,203 shares issued and outstanding at September 30, 2018 and no shares issued and outstanding at September 30, 2017
|
| | | | 4,734,416 | | | | | | — | | | | | ||||
Total convertible preferred stock
|
| | | | 4,734,416 | | | | | | 2,924,441 | | | | | ||||
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; 72,220,351 and 24,933,944 shares issued and outstanding at September 30, 2018 and 2017, respectively
|
| | | | 722,204 | | | | | | 249,339 | | | | | ||||
Additional paid-in capital
|
| | | | 190,040,237 | | | | | | 152,315,088 | | | | | ||||
Accumulated deficit
|
| | | | (216,307,363) | | | | | | (186,215,402) | | | | | ||||
Total stockholders’ equity (deficit)
|
| | | | (25,544,922) | | | | | | (33,650,975) | | | | | ||||
Total liabilities, convertible preferred stock and stockholders’ equity
(deficit) |
| | | $ | 22,283,495 | | | | | $ | 20,733,870 | | | | | ||||
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Collaboration revenues
|
| | | $ | 3,087,560 | | | | | $ | 3,811,519 | | |
Operating expenses: | | | | | | | | | | | | | |
Research and development
|
| | | | 18,504,035 | | | | | | 23,809,749 | | |
General and administrative
|
| | | | 14,227,828 | | | | | | 15,882,033 | | |
| | | | | 32,731,863 | | | | | | 39,691,782 | | |
Loss from operations
|
| | | | (29,644,303) | | | | | | (35,880,263) | | |
Interest expense, net
|
| | | | 3,891,250 | | | | | | 5,625,833 | | |
Loss on extinguishment of debt
|
| | | | 1,252,353 | | | | | | — | | |
Change in fair value of warrant liability
|
| | | | (1,047,729) | | | | | | (3,158,469) | | |
Loss before income taxes
|
| | | | (33,740,177) | | | | | | (38,347,627) | | |
Income tax (benefit) expense
|
| | | | (3,648,216) | | | | | | 501,500 | | |
Net loss
|
| | | | (30,091,961) | | | | | | (38,849,127) | | |
Recognition of beneficial conversion feature upon issuance of Series A and A-1 convertible preferred stock
|
| | | | (16,022,963) | | | | | | (1,176,743) | | |
Series A and A-1 convertible preferred stock dividends and related settlement
|
| | | | (1,903,930) | | | | | | — | | |
Net loss attributable to common stockholders
|
| | | $ | (48,018,854) | | | | | $ | (40,025,870) | | |
Per share information: | | | | | | | | | | | | | |
Net loss per share of common stock, basic
|
| | | $ | (1.22) | | | | | $ | (1.67) | | |
Net loss per share of common stock, diluted
|
| | | $ | (1.22) | | | | | $ | (1.80) | | |
Weighted average shares outstanding, basic
|
| | | | 39,457,664 | | | | | | 24,022,371 | | |
Weighted average shares outstanding, diluted
|
| | | | 39,457,664 | | | | | | 24,041,789 | | |
|
| | |
Convertible Preferred Stock
|
| | |
Stockholders’ Equity (Deficit)
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Series A
|
| |
Series A-1
|
| | |
Series B Convertible
Preferred Stock |
| |
Common Stock
|
| |
Additional
Paid-in Capital |
| |
Accumulated
Deficit |
| |
Total
Stockholders’ Equity (Deficit) |
| |||||||||||||||||||||||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| | |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| ||||||||||||||||||||||||||||||||||||||||||
Balance at October 1, 2016
|
| | | | — | | | | | $ | — | | | | | | — | | | | | $ | — | | | | | | | — | | | | | $ | — | | | | | | 22,802,778 | | | | | $ | 228,028 | | | | | $ | 141,965,342 | | | | | $ | (147,366,275) | | | | | $ | (5,172,905) | | |
Proceeds from exercise of common stock warrants
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 787,018 | | | | | | 7,869 | | | | | | 305,616 | | | | | | — | | | | | | 313,485 | | |
Issuance of vested restricted stock units
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 483,913 | | | | | | 4,840 | | | | | | (4,840) | | | | | | — | | | | | | — | | |
Issuance of common stock in connection with equity facility
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 122,418 | | | | | | 1,224 | | | | | | (1,224) | | | | | | — | | | | | | — | | |
Sale of common stock, net of issuance costs
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 737,817 | | | | | | 7,378 | | | | | | 1,495,749 | | | | | | — | | | | | | 1,503,127 | | |
Sale of Series A convertible preferred, net of costs
|
| | | | 32,628 | | | | | | 2,924,441 | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Series A convertible preferred stock dividends
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (16,985) | | | | | | — | | | | | | (16,985) | | |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 8,571,430 | | | | | | — | | | | | | 8,571,430 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (38,849,127) | | | | | | (38,849,127) | | |
Balance at September 30, 2017
|
| | | | 32,628 | | | | | | 2,924,441 | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 24,933,944 | | | | | | 249,339 | | | | | | 152,315,088 | | | | | | (186,215,402) | | | | | | (33,650,975) | | |
Proceeds from exercise of common stock warrants
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 3,460 | | | | | | 35 | | | | | | (35) | | | | | | — | | | | | | — | | |
Issuance of vested restricted stock units
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 842,889 | | | | | | 8,429 | | | | | | (8,429) | | | | | | — | | | | | | — | | |
Private placement sale of common stock and common stock
warrants, net of costs |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 12,754,766 | | | | | | 127,548 | | | | | | 14,567,572 | | | | | | — | | | | | | 14,695,120 | | |
Sale of Series A convertible preferred stock and common stock warrants, net of costs
|
| | | | 217,372 | | | | | | 14,265,861 | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 6,382,181 | | | | | | — | | | | | | 6,382,181 | | |
Series A convertible preferred stock dividends and related settlement
|
| | | | 17,571 | | | | | | 1,757,093 | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,740,108) | | | | | | — | | | | | | (1,740,108) | | |
Conversion of Series A convertible preferred stock into common stock
|
| | | | (208,836) | | | | | | (14,359,816) | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 31,572,617 | | | | | | 315,726 | | | | | | 14,044,090 | | | | | | — | | | | | | 14,359,816 | | |
Conversion of Series A convertible preferred stock into Series A-1 convertible preferred stock
|
| | | | (58,735) | | | | | | (4,587,579) | | | | | | 58,735 | | | | | | 4,587,579 | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Series A-1 convertible preferred stock dividends and related
settlement |
| | | | — | | | | | | — | | | | | | 1,468 | | | | | | 146,837 | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (146,837) | | | | | | — | | | | | | (146,837) | | |
Conversion of senior secured notes into Series B convertible
preferred stock |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | 1,500,000 | | | | | | 2,661,972 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 2,661,972 | | |
Conversion of Series B convertible preferred stock into common stock
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | (1,500,000) | | | | | | (2,661,972) | | | | | | 2,112,675 | | | | | | 21,127 | | | | | | 2,640,845 | | | | | | — | | | | | | — | | |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,985,870 | | | | | | — | | | | | | 1,985,870 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (30,091,961) | | | | | | (30,091,961) | | |
Balance at September 30, 2018
|
| | | | — | | | | | $ | — | | | | | | 60,203 | | | | | $ | 4,734,416 | | | | | | | — | | | | | $ | — | | | | | | 72,220,351 | | | | | $ | 722,204 | | | | | $ | 190,040,237 | | | | | $ | (216,307,363) | | | | | $ | (25,544,922) | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | |
Year Ended September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
OPERATING ACTIVITIES | | | | ||||||||||
Net loss
|
| | | $ | (30,091,961) | | | | | $ | (38,849,127) | | |
Adjustments to reconcile net loss to net cash used in operating activities:
|
| | | ||||||||||
Depreciation and amortization
|
| | | | 3,054,352 | | | | | | 2,692,100 | | |
Loss on extinguishment of debt
|
| | | | 1,252,353 | | | | | | — | | |
Non-cash interest expense
|
| | | | 1,315,861 | | | | | | 4,014,633 | | |
Stock-based compensation
|
| | | | 1,985,870 | | | | | | 8,571,430 | | |
Change in fair value of warrant liability
|
| | | | (1,047,729) | | | | | | (3,158,469) | | |
Loss on disposal of fixed assets
|
| | | | — | | | | | | 61,867 | | |
Loss on lease termination
|
| | | | 4,173,682 | | | | | | — | | |
Changes in operating assets and liabilities:
|
| | | ||||||||||
Prepaid expenses and other current assets
|
| | | | (1,419,551) | | | | | | 2,607,520 | | |
Other assets
|
| | | | 1,554 | | | | | | 112,439 | | |
Accounts payable
|
| | | | (6,714,137) | | | | | | 5,727,136 | | |
Accrued expenses
|
| | | | (1,664,843) | | | | | | 893,526 | | |
Income taxes payable
|
| | | | (496,000) | | | | | | 497,500 | | |
Deferred revenue
|
| | | | (3,057,561) | | | | | | 1,188,481 | | |
Other liabilities
|
| | | | (331,413) | | | | | | 135,910 | | |
Net cash used in operating activities
|
| | | | (33,039,523) | | | | | | (15,505,054) | | |
INVESTING ACTIVITIES | | | | ||||||||||
Purchase of property and equipment
|
| | | | (2,781,125) | | | | | | (292,086) | | |
Net cash used in investing activities
|
| | | | (2,781,125) | | | | | | (292,086) | | |
FINANCING ACTIVITIES | | | | ||||||||||
Proceeds from the sale of common stock, net of offering costs
|
| | | | 14,695,120 | | | | | | 1,607,396 | | |
Payment of debt issuance costs
|
| | | | — | | | | | | (40,000) | | |
Proceeds from issuance of Series A convertible preferred stock
|
| | | | 21,737,200 | | | | | | 3,262,800 | | |
Proceeds from the sale of senior secured notes and detachable warrants
|
| | | | — | | | | | | 15,000,000 | | |
Proceeds from exercise of common stock warrants
|
| | | | — | | | | | | 253,289 | | |
Change in restricted cash
|
| | | | — | | | | | | 216,086 | | |
Payments of capital leases obligations
|
| | | | (862,906) | | | | | | (991,028) | | |
Repayment of debt
|
| | | | (127,736) | | | | | | (2,677,771) | | |
Payment of financing costs
|
| | | | (1,089,158) | | | | | | — | | |
Net cash provided by financing activities
|
| | | | 34,352,520 | | | | | | 16,630,772 | | |
Net (decrease) increase in cash
|
| | | | (1,468,128) | | | | | | 833,632 | | |
Cash at beginning of year
|
| | | | 3,185,519 | | | | | | 2,351,887 | | |
Cash at end of year
|
| | | $ | 1,717,391 | | | | | $ | 3,185,519 | | |
Supplemental disclosure of cash flow information | | | | ||||||||||
Cash paid for interest
|
| | | $ | 109,979 | | | | | $ | 1,339,644 | | |
Cash paid for income taxes
|
| | | $ | — | | | | | $ | 1,500 | | |
Supplemental schedule of noncash investing activities: | | | | ||||||||||
Purchases of property and equipment in accounts payable and accrued expenses
|
| | | $ | 816,501 | | | | | $ | 68,507 | | |
Supplemental schedule of noncash financing activities: | | | | ||||||||||
Issuance of Series B convertible preferred stock upon conversion of senior secured notes, net of unamortized debt discount
|
| | | $ | 1,409,619 | | | | | $ | — | | |
Issuance of capital lease obligations and debt in connection with purchase of property and
equipment |
| | | $ | 4,444,095 | | | | | $ | 62,230 | | |
Series A and A-1 convertible preferred stock dividends
|
| | | $ | 1,886,945 | | | | | $ | 16,985 | | |
Settlement of Series A and A-1 convertible preferred stock dividends upon issuance of Series A and A-1 convertible preferred stock
|
| | | $ | 1,903,930 | | | | | $ | — | | |
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses
|
| | | $ | — | | | | | $ | 630,717 | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Basic Earnings Per Share | | | | | | | | | | | | | |
Net loss attributable to common stockholders
|
| | | $ | (48,018,854) | | | | | $ | (40,025,870) | | |
Common stock outstanding (weighted average)
|
| | | | 39,457,664 | | | | | | 24,022,371 | | |
Basic net loss per share
|
| | | $ | (1.22) | | | | | $ | (1.67) | | |
Diluted Earnings Per Share | | | | | | | | | | | | | |
Net loss attributable to common stockholders
|
| | | $ | (48,018,854) | | | | | $ | (40,025,870) | | |
Add change in fair value of warrant liability
|
| | | | — | | | | | | (3,158,469) | | |
Diluted net loss
|
| | | | (48,018,854) | | | | | | (43,184,339) | | |
Common stock outstanding (weighted average)
|
| | | | 39,457,664 | | | | | | 24,022,371 | | |
Add shares from dilutive warrants
|
| | | | — | | | | | | 19,418 | | |
Common stock equivalents
|
| | | | 39,457,664 | | | | | | 24,041,789 | | |
Diluted net loss per share
|
| | | $ | (1.22) | | | | | $ | (1.80) | | |
|
| | |
As of September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Series A-1 convertible preferred stock
|
| | | | 9,101,717 | | | | | | — | | |
Performance-based stock units
|
| | | | 129,095 | | | | | | 175,530 | | |
Restricted stock units
|
| | | | 61,109 | | | | | | 939,879 | | |
Stock options
|
| | | | 1,557,145 | | | | | | — | | |
Common stock warrants
|
| | | | 45,292,532 | | | | | | 7,484,504 | | |
| | |
September 30, 2018
|
| |||||||||||||||
| | |
(Level 1)
|
| |
(Level 2)
|
| |
(Level 3)
|
| |||||||||
Liabilities | | | | | | | | | | | | | | | | | | | |
Warrant liability
|
| | | $ | — | | | | | $ | — | | | | | $ | 1,227,225 | | |
| | |
September 30, 2017
|
| |||||||||||||||
| | |
(Level 1)
|
| |
(Level 2)
|
| |
(Level 3)
|
| |||||||||
Liabilities | | | | | | | | | | | | | | | | | | | |
Warrant liability
|
| | | $ | — | | | | | $ | — | | | | | $ | 2,274,954 | | |
|
Balance at October 1, 2016
|
| | | $ | — | | |
|
Issuance of warrants
|
| | | | 5,493,619 | | |
|
Exercise of warrants
|
| | | | (60,196) | | |
|
Change in fair value
|
| | | | (3,158,469) | | |
|
Balance at September 30, 2017
|
| | | | 2,274,954 | | |
|
Change in fair value
|
| | | | (1,047,729) | | |
|
Balance at September 30, 2018
|
| | | $ | 1,227,225 | | |
|
| | |
September 30,
|
| |||
| | |
2018
|
| |
2017
|
|
Risk-free interest rate
|
| |
2.90%
|
| |
1.77%
|
|
Remaining contractual life of warrant
|
| |
3.39 years
|
| |
4.67 years
|
|
Expected volatility
|
| |
82%
|
| |
82%
|
|
Annual dividend yield
|
| |
0%
|
| |
0%
|
|
Fair value of common stock
|
| |
$0.98 per share
|
| |
$1.37 per share
|
|
| | |
September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Laboratory equipment
|
| | | $ | 14,333,624 | | | | | $ | 11,574,473 | | |
Leasehold improvements
|
| | | | 10,095,100 | | | | | | 10,032,640 | | |
Computer software and hardware
|
| | | | 483,807 | | | | | | 472,054 | | |
Land and building
|
| | | | 3,000,000 | | | | | | — | | |
Construction in progress
|
| | | | 2,276,737 | | | | | | 2,654,675 | | |
| | | | | 30,189,268 | | | | | | 24,733,842 | | |
Less: accumulated depreciation and amortization
|
| | | | (11,699,292) | | | | | | (8,644,940) | | |
| | | | $ | 18,489,976 | | | | | $ | 16,088,902 | | |
|
|
2019
|
| | | $ | 1,947,199 |
|
2020
|
| | | | 1,594,917 |
|
2021
|
| | | | 1,493,442 |
|
2022
|
| | | | 1,522,660 |
|
2023
|
| | | | 1,550,878 |
|
Thereafter
|
| | | | 7,280,400 |
| | | | | | 15,389,496 |
|
Less: amounts representing interest
|
| | | | (11,415,446) |
|
Less: current portion
|
| | | | (520,794) |
|
Capital lease obligations, excluding current portion
|
| | | $ | 3,453,256 |
|
| | |
September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Compensation
|
| | | $ | 2,231,122 | | | | | $ | 3,688,592 | | |
Severance and related costs
|
| | | | 396,138 | | | | | | — | | |
Lease termination obligation
|
| | | | 395,071 | | | | | | — | | |
Research and development
|
| | | | 1,065,169 | | | | | | 1,637,657 | | |
Interest payable
|
| | | | 1,991,044 | | | | | | 1,047,122 | | |
Professional fees
|
| | | | 313,585 | | | | | | 521,973 | | |
Director fees
|
| | | | 59,122 | | | | | | 376,695 | | |
Other accrued expenses
|
| | | | 7,220 | | | | | | 65,430 | | |
| | | | $ | 6,458,471 | | | | | $ | 7,337,469 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Restricted stock repurchase notes
|
| | | $ | 800,000 | | | | | $ | 800,000 | | |
Common stock repurchase note
|
| | | | 2,812,500 | | | | | | 2,812,500 | | |
Working capital notes
|
| | | | 1,000,000 | | | | | | 1,000,000 | | |
| | | | | 4,612,500 | | | | | | 4,612,500 | | |
Less: current portion
|
| | | | (4,612,500) | | | | | | (4,612,500) | | |
| | | | $ | — | | | | | $ | — | | |
|
| | |
September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Senior secured notes
|
| | | $ | 13,500,000 | | | | | $ | 15,000,000 | | |
Unamortized debt discount
|
| | | | (320,551) | | | | | | (1,768,300) | | |
| | | | $ | 13,179,449 | | | | | $ | 13,231,700 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Equipment loans
|
| | | $ | 164,967 | | | | | $ | 203,710 | | |
Less: current portion
|
| | | | (66,480) | | | | | | (52,600) | | |
Long-term debt
|
| | | $ | 98,487 | | | | | $ | 151,110 | | |
|
|
2019
|
| | | $ | 66,480 | | |
|
2020
|
| | | | 48,204 | | |
|
2021
|
| | | | 50,283 | | |
| | | | | $ | 164,967 | | |
|
| | |
Balance
October 1, 2017 |
| |
Expensed/
Accrued Expense |
| |
Cash
Payments |
| |
Non-Cash
Items |
| |
Balance
September 30, 2018 |
| |||||||||||||||
Lease termination payments
|
| | | $ | — | | | | | $ | 4,187,696 | | | | | $ | (337,615) | | | | | $ | — | | | | | $ | 3,850,081 | | |
Derecognition of assets and liabilities
|
| | | | — | | | | | | (14,014) | | | | | | — | | | | | | 14.014 | | | | | | — | | |
| | | | $ | — | | | | | $ | 4,173,682 | | | | | $ | (337,615) | | | | | $ | 14,014 | | | | | $ | 3,850,081 | | |
|
| | |
Operating
Leases |
| |||
2019
|
| | | $ | 180,000 | | |
2020
|
| | | | 187,500 | | |
2021
|
| | | | 195,000 | | |
| | | | $ | 562,500 | | |
|
|
Outstanding
|
| |
Exercise Price
Per Share |
| |
Expiration Date
|
| |||
|
3,333,333
|
| | | $ | 6.60 | | | |
February 18, 2019(i)
|
|
|
814,378
|
| | | $ | 0.01 | | | |
November 11, 2019
|
|
|
3,882,001
|
| | | $ | 3.00 | | | |
December 22, 2021(ii)
|
|
|
16,750,000
|
| | | $ | 0.90 | | | |
October 31, 2025
|
|
|
10,256,410
|
| | | $ | 0.975 | | | |
May 10, 2026
|
|
|
10,256,410
|
| | | $ | 0.975 | | | |
June 8, 2026
|
|
|
45,292,532
|
| | | | | | | | | |
|
| | |
Year Ended Ended September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Research and development
|
| | | $ | 19,450 | | | | | $ | 1,001,022 | | |
General and administrative
|
| | | | 1,966,420 | | | | | | 7,570,408 | | |
| | | | $ | 1,985,870 | | | | | $ | 8,571,430 | | |
|
| | |
Number of
Shares |
| |
Weighted
Average Exercise Price |
| |
Weighted
Average Remaining Contractual Term (Years) |
| |||||||||
Balance at October 1, 2017
|
| | | | — | | | | | $ | — | | | | | | | | |
Granted
|
| | | | 1,667,075 | | | | | | 0.93 | | | | | | | | |
Expired/forfeited/cancelled
|
| | | | (209,930) | | | | | | 1.10 | | | | | | | | |
Balance at September 30, 2018
|
| | | | 1,457,145 | | | | | | 0.93 | | | | | | 9.7 | | |
Vested and exercisable
|
| | | | 30,000 | | | | | | 1.32 | | | | | | 0.1 | | |
Vested and expected to vest at September 30, 2018
|
| | | | 1,457,145 | | | | | $ | 0.90 | | | | | | 9.7 | | |
|
| | |
Year Ended
September 30, 2018 |
|
Risk-free interest rate
|
| |
2.80%
|
|
Expected life
|
| |
6.0 years
|
|
Expected volatility
|
| |
71%
|
|
Expected dividend yield
|
| |
—
|
|
| | |
Number of
PSUs |
| |
Base Price Per
PSU |
| ||||||
Balance at October 1, 2016
|
| | | | 247,309 | | | | | $ | 6.33 | | |
Forfeitures
|
| | | | (71,779) | | | | | | 6.46 | | |
Balance at October 1, 2017
|
| | | | 175,530 | | | | | | 6.27 | | |
Forfeitures
|
| | | | (46,435) | | | | | | 6.43 | | |
Balance at September 30, 2018
|
| | | | 129,095 | | | | | | 6.25 | | |
Vested and exercisable
|
| | | | 128,660 | | | | | | 6.23 | | |
Vested and expected to vest at September 30, 2018
|
| | | | 129,095 | | | | | $ | 6.25 | | |
|
| | |
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
|
| | | | (285,559) | | | | | | 3.14 | | |
Balance at October 1, 2017
|
| | | | 939,879 | | | | | | 18.78 | | |
Granted
|
| | | | 20,000 | | | | | | 1.16 | | |
Vested and settled
|
| | | | (842,889) | | | | | | 18.40 | | |
Forfeitures
|
| | | | (55,881) | | | | | | 17.67 | | |
Balance at September 30, 2018
|
| | | | 61,109 | | | | | $ | 19.23 | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
State tax
|
| | | $ | (3,148,216) | | | | | $ | 1,500 | | |
Foreign tax
|
| | | | (500,000) | | | | | | 500,000 | | |
| | | | $ | (3,648,216) | | | | | $ | 501,500 | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
U.S. federal statutory rate
|
| | | | (24.3)% | | | | | | (34.0)% | | |
State taxes, net of federal benefit
|
| | | | (6.9) | | | | | | (6.4) | | |
Sale of New Jersey net operating losses
|
| | | | (7.1) | | | | | | — | | |
Net operating loss
|
| | | | 8.0 | | | | | | — | | |
Change in tax rates
|
| | | | 66.6 | | | | | | — | | |
Foreign witholding tax
|
| | | | (1.5) | | | | | | 1.3 | | |
Permanent differences
|
| | | | (0.6) | | | | | | (2.8) | | |
Foreign tax credits
|
| | | | 1.5 | | | | | | (1.6) | | |
Research and development credit
|
| | | | (22.9) | | | | | | — | | |
Change in valuation allowance
|
| | | | (23.7) | | | | | | 44.8 | | |
Other
|
| | | | 0.1 | | | | | | — | | |
Effective income tax rate
|
| | | | (10.8)% | | | | | | 1.3% | | |
|
| | |
September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Deferred tax assets: | | | | | | | | | | | | | |
Net operating loss carryforwards
|
| | | $ | 39,532,689 | | | | | $ | 48,828,141 | | |
Stock-based compensation
|
| | | | 10,227,514 | | | | | | 14,098,985 | | |
Deferred revenue
|
| | | | 1,264,069 | | | | | | 3,017,238 | | |
Research and development credit carryforward
|
| | | | 8,491,452 | | | | | | 757,701 | | |
Foreign tax credits
|
| | | | 2,357,309 | | | | | | 2,857,309 | | |
Accruals and others
|
| | | | 605,173 | | | | | | 1,539,943 | | |
Gross deferred tax assets
|
| | | | 62,478,206 | | | | | | 71,099,317 | | |
Less: valuation allowance
|
| | | | (61,893,959) | | | | | | (69,902,446) | | |
| | | | | 584,247 | | | | | | 1,196,871 | | |
Deferred tax liability: | | | | | | | | | | | | | |
Fixed assets
|
| | | | (584,247) | | | | | | (1,196,871) | | |
Net deferred tax assets
|
| | | $ | — | | | | | $ | — | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Balance at beginning of year
|
| | | $ | 2,352,129 | | | | | $ | 1,854,629 | | |
Changes based on tax positions related to the current year
|
| | | | (496,000) | | | | | | 497,500 | | |
Balance at end of year
|
| | | $ | 1,856,129 | | | | | $ | 2,352,129 | | |
|
Name
|
| |
Age
|
| |
Position(s)
|
|
Executive Officers | | | | ||||
Lawrence A. Kenyon | | |
53
|
| | President, Chief Executive Officer, Chief Financial Officer, Treasurer, Corporate Secretary and Director | |
Kenneth M. Bahrt, M.D. | | |
65
|
| | Chief Medical Officer | |
Terry Dagnon | | |
57
|
| | Chief Operating Officer | |
Jeff Evanson | | |
50
|
| | Chief Commercial Officer | |
Non-Employee Directors | | | | ||||
Ralph H. “Randy” Thurman | | |
69
|
| | Executive Chairman | |
Yezan Haddadin | | |
43
|
| | Director | |
Kurt J. Hilzinger | | |
58
|
| | Director | |
Pankaj Mohan, Ph.D. | | |
54
|
| | Director | |
Faisal G. Sukhtian | | |
34
|
| | Director | |
Joe Thomas | | |
61
|
| | Director | |
Joerg Windisch, Ph.D. | | |
48
|
| | Director | |
Name and Principal Position
|
| |
Year
|
| |
Salary
($) |
| |
Bonus
($)(1) |
| |
Stock
Awards ($)(2) |
| |
Option
Awards ($)(3) |
| |
All
Other Compensation ($)(4) |
| |
Total
($) |
| |||||||||||||||||||||
Pankaj Mohan, Ph.D.(5) | | | | | 2018 | | | | | | 350,538 | | | | | | — | | | | | | — | | | | | | — | | | | | | 875,172 | | | | | | 1,225,710 | | |
Director, former Chairman, President and Chief Executive Officer
|
| | | | 2017 | | | | | | 490,000 | | | | | | — | | | | | | 555,942 | | | | | | — | | | | | | 31,610 | | | | | | 1,077,551 | | |
Lawrence A. Kenyon(6) | | | | | 2018 | | | | | | 371,635 | | | | | | — | | | | | | — | | | | | | 326,192 | | | | | | 18,305 | | | | | | 716,132 | | |
Director, Chief Executive Officer, President, Chief Financial Officer, Treasurer and Corporate Secretary
|
| | | | 2017 | | | | | | 350,000 | | | | | | 100,000 | | | | | | 128,065 | | | | | | — | | | | | | 16,940 | | | | | | 595,005 | | |
Kenneth M. Bahrt, M.D. | | | | | 2018 | | | | | | 400,000 | | | | | | — | | | | | | — | | | | | | — | | | | | | 29,082 | | | | | | 429,082 | | |
Chief Medical Officer
|
| | | | 2017 | | | | | | 400,000 | | | | | | 100,000 | | | | | | 108,209 | | | | | | | | | | | | 21,469 | | | | | | 629,678 | | |
Stephen J. McAndrew, Ph.D.(7) | | | | | 2018 | | | | | | 300,000 | | | | | | — | | | | | | — | | | | | | 14,060 | | | | | | 12,011 | | | | | | 326,071 | | |
Former Senior Vice President, Business Strategy & Development
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | |
Option awards(1)
|
| |
Stock awards(1)
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Name
|
| |
Grant date
|
| |
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 ($) |
| |
Option
expiration date |
| |
Number
of shares or units of stock that have not vested (#) |
| |
Market
value of shares or units of stock that have not vested ($) |
| |
Equity
incentive plan awards: Number of unearned shares, units or other rights that have not vested (#) |
| |
Equity
incentive plan awards: Market or payout value of unearned shares, units or other rights that have not vested ($) |
| ||||||||||||||||||||||||||||||
Lawrence A. Kenyon
|
| | | | 8/1/2018 | | | | | | — | | | | | | 500,000(2) | | | | | | — | | | | | | 0.86 | | | | | | 8/1/2028 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Lawrence A. Kenyon
|
| | | | 12/31/2015 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 21,739(3) | | | | | | 21,304 | | | | | | — | | | | | | — | | |
Kenneth M. Bahrt, M.D.
|
| | | | 06/22/2015 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 14,493(4) | | | | | | 14,203 | | | | | | — | | | | | | — | | |
Stephen J. McAndrew, Ph.D.
|
| | | | 06/15/2018 | | | | | | — | | | | | | 30,000(5) | | | | | | — | | | | | | 0.90 | | | | | | 06/15/2028 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Name
|
| |
Fees Earned or
Paid in Cash(1) ($) |
| |
Option
Awards(2) ($) |
| |
All Other
Compensation(3) ($) |
| |
Total
($) |
| ||||||||||||
Claudio Albrecht(4)
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Todd C. Brady, M.D., Ph.D.(5)
|
| | | | 6,339 | | | | | | 5,292 | | | | | | — | | | | | | 11,631 | | |
Scott Canute(4)
|
| | | | 28,447 | | | | | | — | | | | | | — | | | | | | 28,447 | | |
Albert Dyrness(5)
|
| | | | 4,198 | | | | | | 5,292 | | | | | | — | | | | | | 9,490 | | |
Yezan Haddadin(6)
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Kurt Hilzinger
|
| | | | 62,500 | | | | | | 21,421 | | | | | | — | | | | | | 83,921 | | |
Pankaj Mohan, Ph.D.(7)
|
| | | | 9,997 | | | | | | 9,837 | | | | | | 61,250 | | | | | | 81,084 | | |
Faisal G. Sukhtian(6)
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Joe Thomas(6)
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Randy Thurman(8)
|
| | | | 59,494 | | | | | | 73,454 | | | | | | — | | | | | | 132,948 | | |
Joerg Windisch, Ph.D.
|
| | | | 20,986 | | | | | | 23,327 | | | | | | — | | | | | | 44,313 | | |
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 |
| | | | | | | | |
Option awards
|
| |||||||||||||||||||||||||||
Name
|
| |
Grant date
|
| |
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 |
| ||||||||||||||||||
Randy Thurman
|
| | | | 11/09/2018 | | | | | | 567,522 | | | | | | — | | | | | | — | | | | | | 0.89 | | | | | | 11/09/2018 | | |
Kurt Hilzinger
|
| | | | 11/09/2018 | | | | | | 203,851 | | | | | | — | | | | | | — | | | | | | 0.89 | | | | | | 11/09/2018 | | |
Joerg Windisch, Ph.D.
|
| | | | 11/09/2018 | | | | | | 130,465 | | | | | | — | | | | | | — | | | | | | 0.89 | | | | | | 11/09/2018 | | |
Pankaj Mohan, Ph.D.
|
| | | | 11/09/2018 | | | | | | 114,157 | | | | | | — | | | | | | — | | | | | | 0.89 | | | | | | 11/09/2018 | | |
| | |
Common Stock
|
| |
Series A-1 Convertible
|
| | |||||||||||||||||||||||
Name of Beneficial Owner
|
| |
Number of Shares
Beneficially Owned |
| |
%
|
| |
Number of Shares
Beneficially Owned |
| |
%
|
| |
% of Total
Voting Power |
| |||||||||||||||
Five Percent Stockholders (other than directors and officers): | | | | | | | |||||||||||||||||||||||||
BioLexis Pte. Ltd(1)
|
| | | | 99,269,168 | | | | | | 78.1% | | | | | | 60,203 | | | | | | 100.0% | | | | | | 69.0% | | |
| | |
Common Stock
|
| |
Series A-1 Convertible
|
| | |||||||||||||||||||||||
Name of Beneficial Owner
|
| |
Number of Shares
Beneficially Owned |
| |
%
|
| |
Number of Shares
Beneficially Owned |
| |
%
|
| |
% of Total
Voting Power |
| |||||||||||||||
Named Executive Officers and Directors: | | | | | | | |||||||||||||||||||||||||
Lawrence A. Kenyon, Director, Chief Executive Officer, Chief
Financial Officer, Treasurer and Corporate Secretary |
| | | | 35,474 | | | | | | * | | | | | | — | | | | | | — | | | | | | † | | |
Kenneth M. Bahrt, Chief Medical Office(2)
|
| | | | 33,627 | | | | | | * | | | | | | — | | | | | | — | | | | | | † | | |
Ralph H. “Randy” Thurman, Executive Chairman(3)
|
| | | | 576,522 | | | | | | * | | | | | | — | | | | | | — | | | | | | † | | |
Yezan Haddadin, Director
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Pankaj Mohan, Ph.D., Director(4)
|
| | | | 8,383,714 | | | | | | 10.4% | | | | | | |||||||||||||||
Kurt J. Hilzinger, Director(5)
|
| | | | 256,621 | | | | | | * | | | | | | — | | | | | | — | | | | | | † | | |
Faisal G. Sukhtian, Director
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Joe Thomas, Director
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Joerg Windisch, Ph.D., Director(6)
|
| | | | 130,465 | | | | | | * | | | | | | | | | | | | | | | | | | † | | |
All executive officers and directors as a group (11 persons)
|
| | | | 9,416,423 | | | | | | 11.5% | | | | | | — | | | | | | — | | | | | | 9.3% | | |
Plan Category
|
| |
Number of securities
to be issued upon exercise of outstanding options, warrants and rights |
| |
Weighted-average
exercise price of outstanding options, warrants and rights |
| |
Number of securities
remaining available for future issuance under equity compensation plans |
| |||||||||
Equity compensation plans approved by security
holders: |
| | | | |||||||||||||||
2011 Stock Incentive Plan
|
| | | | 129,095 | | | | | $ | 6.25(1) | | | | | | —(2) | | |
2015 Equity Incentive Plan
|
| | | | 1,518,254 | | | | |
|
(3)
|
| | | | | 5,558,678(4) | | |
2016 Employee Stock Purchase Plan
|
| | | | — | | | | | | — | | | | | | 545,162(5) | | |
Equity compensation plans not approved by security holders:
|
| | | | |||||||||||||||
None
|
| | | | — | | | | | | — | | | | | | — | | |
Total
|
| | | | 1,647,349 | | | | | | | | | | | | 6,103,840 | | |
|
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
|
|
| | |
Fiscal Year Ended
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
Audit Fees
|
| | | $ | 350,000 | | | | | $ | 350,000 | | |
Audit-related Fees
|
| | | | 32,500 | | | | | | 27,500 | | |
Tax Fees
|
| | | | 139,986 | | | | | | 31,504 | | |
Total Fees
|
| | | $ | 522,486 | | | | | $ | 409,004 | | |
|
| (a) | | | (1) | | |
The financial statements required by Item 15(a) are filed in Item 8 of this Annual Report on Form10-K.
|
|
| | | | (2) | | |
The financial statement schedules required by Item 15(a) are omitted because they are not applicable, not required or the required information is included in the financial statements or notes thereto as filed in Item 8 of this Annual Report on Form 10-K.
|
|
Exhibit Number
|
| |
Description
|
|
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | |
Exhibit Number
|
| |
Description
|
|
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | |
Exhibit Number
|
| |
Description
|
|
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | Form of Series A warrant certificate (included in Exhibit A to Exhibit 10.29). | | |
| | | ||
| | | ||
| | |
Exhibit Number
|
| |
Description
|
|
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | |
Exhibit Number
|
| |
Description
|
|
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | Consent of independent registered public accounting firm. | | |
| | | ||
| | | ||
101.INS
|
| | XBRL Instance Document | |
101.SCH
|
| | XBRL Taxonomy Extension Schema Document | |
101.CAL
|
| | XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF
|
| | XBRL Definition Linkbase Document | |
101.LAB
|
| | XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE
|
| | XBRL Taxonomy Extension Presentation Linkbase Document | |
| Date: December 18, 2018 | | | By: | | | /s/ Lawrence A. Kenyon | |
| | | | Name: | | | Lawrence A. Kenyon | |
| | | | Title: | | | President, Chief Executive Officer and Chief Financial Officer | |
|
/s/ Ralph H. Thurman
Ralph H. Thurman
|
| |
Executive Chairman
|
| |
December 18, 2018
|
|
|
/s/ Lawrence A. Kenyon
Lawrence A. Kenyon
|
| |
President, Chief Executive Officer, Chief Financial Officer, Treasurer, Secretary and Director
(Principal Executive, Financial and Accounting Officer) |
| |
December 18, 2018
|
|
|
/s/ Yezan Haddadin
Yezan Haddadin
|
| |
Director
|
| |
December 18, 2018
|
|
|
/s/ Kurt J. Hilzinger
Kurt J. Hilzinger
|
| |
Director
|
| |
December 18, 2018
|
|
|
/s/ Pankaj Mohan, Ph.D.
Pankaj Mohan, Ph.D.
|
| |
Director
|
| |
December 18, 2018
|
|
|
/s/ Faisal G. Sukhtian
Faisal G. Sukhtian
|
| |
Director
|
| |
December 18, 2018
|
|
|
/s/ Joe Thomas
Joe Thomas
|
| |
Director
|
| |
December 18, 2018
|
|
|
/s/ Joerg Windisch, Ph.D.
Joerg Windisch, Ph.D.
|
| |
Director
|
| |
December 18, 2018
|
|