TYME TECHNOLOGIES, INC. - Quarter Report: 2016 September (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: September 30, 2016
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period:
Commission file number: 333-179311
TYME TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
Delaware | 45-3864597 |
(State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
44 Wall Street - 12th Floor
New York, New York 10005
(Address of principal executive offices)
(Zip Code)
(646) 205-1603
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ]
(Note: The registrant is a voluntary filer of reports and has filed during the preceding 12 months all reports it would have been required to file by Section 13 or 15(d) of the Securities Exchange Act if the registrant had been subject to one of such Sections.)
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] No [ ]
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer [ ] |
| Accelerated filer [X] |
Non-accelerated filer [ ] |
| Smaller reporting company [ ] |
(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X]
As of October 31, 2016, there were 87,677,838 shares of the registrant’s common stock, par value $0.0001 per share, issued and outstanding. (Includes 3,500,000 shares which have been placed into escrow and are subject to surrender for cancellation.) See Part II, Item 1 of this report)
TABLE OF CONTENTS
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PART I- FINANCIAL INFORMATION | ||
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Item 1. | Financial Statements | 1 |
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| Condensed Consolidated Balance Sheets as of September 30, 2016 (unaudited) and December 31, 2015 | 1 |
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| Condensed Consolidated Statements of Operations (unaudited) for the three and nine months ended September 30, 2016 and 2015 | 2 |
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| Condensed Consolidated Statements of Stockholders’ Equity (unaudited) for the nine months ended September 30, 2016 | 3 |
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| Condensed Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2016 and 2015 | 4 |
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| Notes to Unaudited Condensed Consolidated Financial Statements | 5 |
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Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 18 |
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Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 23 |
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Item 4. | Controls and Procedures | 23 |
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PART II- OTHER INFORMATION | ||
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Item 1. | Legal Proceedings | 24 |
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Item 1A. | Risk Factors | 25 |
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Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 26 |
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Item 3. | Defaults upon senior securities | 26 |
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Item 4. | Mine Safety Disclosures | 26 |
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Item 5. | Other Information | 26 |
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Item 6. | Exhibits | 26 |
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SIGNATURES | 27 |
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
Tyme Technologies, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
| September 30, |
| December 31, |
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| 2016 |
| 2015 |
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| (Unaudited) |
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Assets |
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Current assets |
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Cash and cash equivalents | $ | 3,079,796 |
| $ | 4,446,284 |
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Prepaid and other assets |
| 122,008 |
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| 30,784 |
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Total current assets |
| 3,201,804 |
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| 4,477,068 |
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Property and equipment, net |
| 9,680 |
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| 12,878 |
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Total assets | $ | 3,211,484 |
| $ | 4,489,946 |
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Liabilities and Stockholders’ Equity |
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Current liabilities |
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Accounts payable and other current liabilities | $ | 2,247,798 |
| $ | 1,474,331 |
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Insurance note payable |
| 104,457 |
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| — |
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Total current liabilities |
| 2,352,255 |
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| 1,474,331 |
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Total liabilities |
| 2,352,255 |
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| 1,474,331 |
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Commitments and contingencies (See Note 8) |
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Stockholders’ equity |
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Preferred stock, $0.0001 par value, 10,000,000 shares authorized at September 30, 2016 and December 31, 2015, -0- shares issued and outstanding at September 30, 2016 and December 31, 2015 |
| — |
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| — |
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Common stock, $0.0001 par value, 300,000,000 shares authorized, 87,677,838 issued and outstanding at September 30, 2016, and 86,836,370 issued and outstanding at December 31, 2015 |
| 8,770 |
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| 8,685 |
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Additional paid in capital |
| 28,638,031 |
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| 18,911,110 |
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Accumulated deficit |
| (27,787,572 | ) |
| (15,904,180 | ) |
Total stockholders’ equity |
| 859,229 |
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| 3,015,615 |
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Total liabilities and stockholders’ equity | $ | $3,211,484 |
| $ | 4,489,946 |
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The Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
- 1 -
Tyme Technologies, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
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| Three Months Ended |
| Nine Months ended |
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| 2016 |
| 2015 |
| 2016 |
| 2015 |
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Revenues |
| $ | — |
| $ | — |
| $ | — |
| $ | — |
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Operating expenses: |
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Research and development |
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| 1,130,468 |
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| 1,357,394 |
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| 3,524,480 |
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| 2,662,403 |
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General and administrative |
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| 1,990,471 |
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| 958,922 |
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| 8,358,912 |
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| 3,502,336 |
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Total operating expenses |
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| 3,120,939 |
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| 2,316,316 |
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| 11,883,392 |
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| 6,164,739 |
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Loss from operations |
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| (3,120,939 | ) |
| (2,316,316 | ) |
| (11,883,392 | ) |
| (6,164,739 | ) |
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Interest expense |
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| — |
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| — |
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| — |
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| 3,503,301 |
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Net loss |
| $ | (3,120,939 | ) | $ | (2,316,316 | ) | $ | (11,883,392 | ) | $ | (9,668,040 | ) |
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Basic and diluted loss per common share |
| $ | (0.04 | ) | $ | (0.03 | ) | $ | (0.14 | ) | $ | (0.12 | ) |
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Basic and diluted weighted average shares outstanding |
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| 84,177,838 |
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| 86,013,196 |
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| 84,043,124 |
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| 81,853,065 |
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The Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
- 2 -
Tyme Technologies, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’ Equity
For the Nine Months ended September 30, 2016
(Unaudited)
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| Common Stock |
| Additional |
| Accumulated |
| Total |
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| Shares |
| Amount |
| Capital |
| deficit |
| Equity |
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Balance, January 1, 2016 |
| 86,836,370 |
| $ | 8,685 |
| $ | 18,911,110 |
| $ | (15,904,180 | ) | $ | 3,015,615 |
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Issuance of common stock in private placement offering for cash, net of associated expense |
| 775,000 |
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| 78 |
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| 3,032,204 |
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| — |
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| 3,032,282 |
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Stock-based compensation |
| — |
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| — |
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| 6,394,724 |
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| — |
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| 6,394,724 |
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Issuance of common stock for services |
| 50,000 |
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| 5 |
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| 199,995 |
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| — |
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| 200,000 |
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Issuance of stock to Scientific Advisory Board members |
| 16,468 |
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| 2 |
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| 99,998 |
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| — |
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| 100,000 |
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Net loss |
| — |
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| — |
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| — |
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| (11,883,392 | ) |
| (11,883,392 | ) |
Balance, September 30, 2016 |
| 87,677,838 |
| $ | $8,770 |
| $ | $28,638,031 |
| $ | (27,787,572 | ) | $ | 859,229 |
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The Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
- 3 -
Tyme Technologies, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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| Nine Months ended |
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| 2016 |
| 2015 |
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Cash flows from operating activities: |
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Net loss |
| $ | (11,883,392 | ) | $ | (9,668,040 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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| 3,198 |
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| 3,222 |
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Issuance of common stock for services |
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| 200,000 |
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| 625,000 |
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Stock-based compensation and stock issued to Scientific Advisory Board members |
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| 6,494,724 |
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| 504,855 |
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Inducement for conversion of Bridge Note to common shares |
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| — |
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| 3,465,000 |
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Changes in operating assets and liabilities: |
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Prepaid and other assets |
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| 140,876 |
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| 28,350 |
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Accounts payable and other current liabilities |
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| 773,467 |
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| 96,139 |
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Net cash used in operating activities |
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| (4,271,127 | ) |
| (4,945,474 | ) |
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Cash flows from investing activities: |
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Net cash used in investing activities |
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| — |
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Cash flows from financing activities: |
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Repayment from stockholders/members |
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| 355,766 |
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Insurance note payments |
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| (127,643 | ) |
| — |
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Proceeds from Bridge Note |
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| — |
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| 960,000 |
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Proceeds from private placement offering of common stock and warrants, net |
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| 3,032,282 |
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| 4,264,950 |
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Proceeds from the collection of stock subscription receivable |
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| — |
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| 1,250,000 |
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Net cash provided by financing activities |
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| 2,904,639 |
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| 6,830,716 |
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Net (decrease) increase in cash |
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| (1,366,488 | ) |
| 1,885,242 |
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Cash and cash equivalents - beginning of period |
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| 4,446,284 |
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| 9,724 |
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Cash and cash equivalents - end of period |
| $ | 3,079,796 |
| $ | 1,894,966 |
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Supplemental Cash Flow Information: |
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Cash paid for income taxes is as follows: |
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Income taxes |
| $ | — |
| $ | — |
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Noncash investing and financing activities: |
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Financing of insurance premiums |
| $ | 232,100 |
| $ | — |
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Conversion of the Bridge Note and all accrued interest into shares of common stock |
| $ | — |
| $ | 2,404,474 |
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Issuance of subscription receivable for shares issued in conjunction with private placement offering |
| $ | — |
| $ | 2,500,000 |
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Inducement for conversion of Bridge Note to common shares |
| $ | — |
| $ | 3,465,000 |
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Derivative liability associated with the price protection feature of shares of common stock issued in PPO and Bridge Note conversion |
| $ | — |
| $ | 376,300 |
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The Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
- 4 -
Tyme Technologies, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
September 30, 2016
(Unaudited)
Note 1. Nature of Business and Basis of Presentation.
The accompanying consolidated financial statements include the results of operations of Tyme Technologies, Inc. (“Tyme Tech”) and its wholly owned subsidiaries, Tyme Inc. (“Tyme”) and Luminant Biosciences, LLC (“Luminant”) (collectively, the “Company”). Luminant conducted the initial research and development of the Company’s therapeutic platform. Since January 1, 2014, the majority of the Company’s research and development activities and other business efforts have been conducted by Tyme and all of the Company’s patent and patent application rights are presently held by Tyme.
On October 27, 2016, the Board of Directors of Tyme Tech approved a change in fiscal year end from December 31 to March 31 of each year. As a result of the change in fiscal year, Tyme Tech prepared and filed a transition report on Form 10-Q (the “Transition Report”).
Tyme Tech was incorporated in the State of Florida on November 22, 2011, to engage in the business of producing, marketing and selling an ultra-premium vodka product to retailers. Management determined to cease the ultra-premium vodka business and attempt to acquire other assets or business operations that would maximize shareholder value. Effective as of September 18, 2014, the Company (then constituting a Florida corporation with the name Global Group Enterprises Corp.) reincorporated in the State of Delaware by merging into its wholly-owned Delaware subsidiary, Tyme Technologies, Inc., which was formed on August 22, 2014 specifically for this purpose (the “Reincorporation”). Tyme Technologies, Inc. was the surviving corporation in such merger.
On March 5, 2015, Tyme Tech consummated a reverse triangular merger with Tyme (the “Merger”). (See Reverse Triangular Merger below.) The Merger resulted in Tyme becoming a wholly-owned subsidiary of Tyme Tech. Tyme is a clinical-stage biopharmaceutical company focused on the development and commercialization of highly targeted cancer therapeutics with a broad range of oncology indications for humans. Tyme was incorporated in Delaware in 2013 and its operations to date have been directed primarily toward developing business strategies, research and development activities and preparing for clinical trials for human oncologic product candidates.
The Company is currently formulating its regulatory and drug development program for its lead drug candidate, SM-88. During the fourth quarter of 2015, the Company’s Investigational New Drug Application for its SM-88 drug candidate for breast cancer patients (the “IND”) was accepted by the United States Food and Drug Administration (the “FDA”). Subsequent to the FDA’s acceptance of our IND for SM-88 and approval of our clinical trial for breast cancer, we made a determination, based on input from various sources and the strong interest of several clinical sites, to prioritize our clinical trial objectives by initiating a study in prostate cancer. On June 13, 2016, we announced that we have begun recruiting for a phase Ib/II clinical trial, using our proprietary compound, SM-88, to use in human prostate cancer. We are also evaluating protocols for clinical studies of SM-88 in pancreatic and breast cancer.
Reverse Triangular Merger
On March 5, 2015, Tyme Tech consummated a reverse triangular merger whereby a newly formed subsidiary formed specifically for the transaction merged with and into Tyme. The Merger resulted in Tyme becoming a wholly-owned subsidiary of Tyme Tech and the stockholders of Tyme as of immediately prior to the effective time of the Merger, receiving, in the aggregate, common stock of the Company equal to approximately 79% of the total number of shares of Company common stock outstanding immediately following such issuance to such former Tyme stockholders (34,000 shares of Company common stock for every one share of Tyme common stock outstanding as of the closing of the Merger). The Merger resulted in the Company issuing a total of 68,000,000 shares of common stock to the Pre-Merger Tyme stockholders and 12,724,000 shares to the Tyme Tech stockholders as of the date of the Merger. (See Note 7. Stockholders’ Equity.)
The Merger Agreement contained representations and warranties and pre- and post-closing covenants of each party and customary closing conditions. Breaches of the representations and warranties under the Merger Agreement are subject to indemnification provisions. Each of the pre-Merger Tyme stockholders initially received in the Merger 95% of the shares to which each such stockholder was entitled under the terms of the Merger Agreement, with the remaining 5% of such shares being held in escrow for two years to satisfy post-closing claims for indemnification by the Company (“Indemnity Shares”), pursuant to an Indemnification Shares Escrow Agreement. Any of the Indemnity Shares remaining in escrow at the end of such two-year period shall be distributed to the pre-Merger Tyme stockholders on a pro rata basis.
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Contemporaneous with the closing of the Merger, among other matters, the Company completed a private placement offering (the “PPO”) of 2,716,000 shares of Company common stock (the “PPO Shares”) for gross proceeds of $6,790,000 (of which, $4,264,000 was tendered in cash and the remaining subscription price paid by the delivery of a three-month promissory note in the principal amount of $2,500,000 (“PPO Note”). In addition, a Tyme convertible promissory note in the principal amount of $2,310,000 (the “Bridge Note”) was converted into 2,310,000 shares (the “Bridge Note Shares”) of Company common stock. The foregoing aggregate 79% ownership of the post-Merger Company by the former Tyme stockholders was calculated giving effect to the issuances of Company common stock in the PPO, the conversion of the Bridge Note and surrender of stock for cancellation by certain stockholders of the Pre-Merger Company. The purchaser of the PPO Shares and party receiving the Bridge Shares upon conversion of the Bridge Note were granted certain registration rights with respect to such shares (such shares being collectively referred to as the PPO/Bridge Note Conversion Registrable Shares”). The PPO Note was originally secured by the escrow of 5,000,000 shares of Company common stock pursuant to a Subscription Note Shares Escrow Agreement, dated as of March 5, 2015 (the “Subscription Note Escrow Agreement”). As originally provided in the Subscription Note Escrow Agreement, to the extent that the PPO Note was not paid at or prior to its maturity date of June 5, 2015, the escrowed shares would be forfeited for cancellation at the rate of one share for every $0.50 of PPO Note principal not paid. The Company received a payment of $1,250,000 in June 2015 and the maturity date on the remaining principal amount of the PPO Note was extended to July 6, 2015 pursuant to an Omnibus Amendment, dated as of June 5, 2015 (the “First Omnibus Amendment”). The Company entered into a Second Omnibus Amendment as of July 23, 2015 (the “Second Omnibus Amendment”), pursuant to which the terms of certain agreements entered into in connection with the Merger were modified and amended. Under the Second Omnibus Amendment, (x) the Company agreed to the extension of the maturity date of the remaining $1,250,000 outstanding amount due under the PPO Note to a date five business days following the Company providing the maker of the PPO Note of written evidence that an Investigational New Drug Application for the Company’s SM-88 drug candidate has been submitted by the Company to the FDA, (y) the holder of all of the PPO/Bridge Note Conversion Registrable Shares irrevocably waived any liquidated damages with respect to the date of filing or the effective date of the registration statement contemplated by a Registration Rights Agreement entered into in connection with the consummation of the Merger and PPO and (z) the amount of shares that the former-Tyme stockholders may include in such registration statement was increased to 15% of the total number of shares such stockholders received in connection with the Merger.
At the point of Merger and since inception, Tyme Tech was essentially a public reporting business combination shell with no substantive business operations. As such, Tyme Tech had no revenues and operating profits that require separate identification.
The Merger established a public forum for the Company. Subject to executing on the Company’s goals, management envisages that the public forum may help the Company secure necessary future funding in the public markets as the Company further develops its business as a clinical-stage biopharmaceutical enterprise focused on the development and commercialization of highly targeted cancer therapeutics for humans with a broad range of oncology indications.
The transaction costs associated with the Merger relate to professional fees incurred in respect of legal, investor relations, accounting and audit. All such transaction costs total approximately $1,000,000 and are included in general and administrative expense for the nine months ended September 30, 2015.
For accounting purposes, the acquisition of Tyme by Tyme Tech was considered a reverse acquisition, an acquisition transaction where the acquired company, Tyme, is considered the acquirer for accounting purposes, notwithstanding the form of the transaction. The primary reason the transaction was treated as a purchase by Tyme rather than a purchase by Tyme Tech was because Tyme Tech was a public reporting business combination shell company with limited operations and Tyme’s stockholders gained majority control of the outstanding voting power of the Company’s equity securities through their collective ownership of a majority of the outstanding shares of Company common stock. Consequently, reverse acquisition accounting has been applied to the transaction.
In conjunction with the reverse acquisition, Tyme Tech changed its fiscal year-end from November 30 to December 31, the historical fiscal year-end of Tyme. The capital structure, including the number and type of shares issued appearing in the consolidated balance sheets for the periods presented, reflects that of the legal parent or accounting acquiree, Tyme Tech, including the shares issued to effect the reverse acquisition after the Merger and the capital structure of Tyme modified by the 34,000-for-1 exchange ratio in the Merger for the periods prior to the consummation of the Merger. As a result of the Merger and its accounting treatment as a reverse acquisition, stockholders’ equity has been retrospectively adjusted as of the earliest period presented in these consolidated financial statements. There was no change to total stockholders’ equity (deficit) as a result of the Merger.
- 6 -
Going Concern
The Company has incurred losses and negative cash flows from operations since inception (July 26, 2013) and has an accumulated deficit of $27,787,572 as of September 30, 2016. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenues from its products currently in development. The Company’s primary sources of liquidity to date have been the issuance of common stock, convertible promissory notes and contributed capital by its founders. Substantial additional financing will be needed by the Company to fund its operations and to seek applicable FDA and foreign governmental authorization to commercially market its product candidates. There is no assurance that such financing will be available when needed or on acceptable terms. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
The consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded assets amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
Management is evaluating different strategies to obtain the required additional funding for future operations. These strategies may include, but are not limited to, additional funding from current or new investors, officers and directors; borrowings of debt; public or private offerings of the Company’s equity or debt securities; partnerships and/or collaborations. There can be no assurance that any of these future-funding efforts will be successful.
The Company is subject to those risks associated with any specialty pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approval or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants, as well as third party contractors.
Note 2. Summary of Significant Accounting Policies.
Basis of Presentation
The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Unaudited Interim Financial Information
The accompanying balance sheet as of December 31, 2015, was derived from the Company’s audited financial statements included in Form 10-K filed on March 30, 2016. The interim unaudited condensed consolidated financial statements should be read in conjunction with the annual financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K.
The accompanying condensed consolidated balance sheet as of September 30, 2016, the condensed consolidated statements of operations for the three and nine months ended September 30, 2016 and 2015, the condensed consolidated statement of stockholders’ equity for the nine months ended September 30, 2016 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2016 and 2015 are unaudited.
The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of September 30, 2016 and the results of its operations for the three and nine months ended September 30, 2016 and 2015 as well as its cash flows for the nine months ended September 30, 2016 and 2015.
The interim unaudited condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission. The results of operations for the interim periods presented are not necessarily indicative of the results to be expected for any subsequent quarter or for the year ending December 31, 2016. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information not misleading.
- 7 -
Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended March 31, 2016 included in the Company’s Transition Report on Form 10-Q filed with the SEC on November 7, 2016. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies.
Recent Accounting Pronouncements
In August 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update or ASU, 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”), which amended the existing accounting standards for the statement of cash flows. The amendments provide guidance on eight classification issues related to the statement of cash flows. The Company is required to adopt the guidance in the first quarter of fiscal 2019 and early adoption is permitted. The amendments should be applied retrospectively to all periods presented. For issues that are impracticable to apply retrospectively, the amendments may be applied prospectively as of the earliest date practicable. The Company is currently in the process of assessing the impact of ASU 2016-15 on its statement of cash flows.
In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (“ASU 2016-13”), which introduces a new model for recognizing credit losses on financial instruments based on an estimate of current expected credit losses. ASU 2016-13 will apply to (1) loans, accounts receivable, trade receivables, and other financial assets measured at amortized cost, (2) loan commitments and other off-balance sheet credit exposures, (3) debt securities and other financial assets measured at fair value through other comprehensive income, and (4) beneficial interests in securitized financial assets. ASU 2016-13 will be effective in fiscal years beginning after December 15, 2019 including interim periods within those fiscal years. The Company is currently in the process of assessing the impact of ASU 2016-13 on the Company’s financial statements and related disclosures.
In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”), which provides for simplification of certain aspects of employee share-based payment accounting including income taxes, classification of awards as either equity or liabilities, accounting for forfeitures and classification on the statement of cash flows. ASU 2016-09 will be effective for the Company in the first quarter of 2017 and will be applied either prospectively, retrospectively or using a modified retrospective transition approach depending on the area covered in this update. The Company is currently in the process of assessing the impact of ASU 2016-09 on the Company’s consolidated financial statements and disclosures.
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 is effective for annual periods beginning after December 15, 2019, and for interim periods within fiscal years beginning after December 15, 2020, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact that the standard will have on its consolidated financial statements.
In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments - Overall (Subtopic 825-10), Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-1”), which addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. ASU 2016-01 will be effective for the Company for annual periods and interim periods within those annual periods beginning after December 15, 2018 and early adoption is not permitted. The Company does not anticipate that the adoption of this standard will have a material impact on its consolidated financial statements.
In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 740). The amendments in this update require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. The Company did not retrospectively adjust the prior periods within the Balance Sheet. The early adoption ASU 2015-17 did not have a material impact on the Company’s financial position, results of operations or liquidity. The reason for the change is to simplify the presentation of deferred income taxes.
- 8 -
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which provides guidance on determining when and how reporting entities must disclose going-concern uncertainties in their financial statements. The new standard requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date of issuance of the entity’s financial statements (or within one year after the date on which the financial statements are available to be issued, when applicable). Further, an entity must provide certain disclosures if there is “substantial doubt about the entity’s ability to continue as a going concern.” This guidance is effective for annual reporting periods ending after December 15, 2016, and for annual periods and interim periods thereafter, with early adoption permitted. The Company does not anticipate that the adoption of this standard will have a material impact on its consolidated financial statements, other than potentially on the footnote disclosures.
Note 3. Net Loss Per Common Share
The following table sets forth the computation of basic and diluted net loss per common share for the periods indicated (in thousands, except share and per share data):
|
| Three Months Ended |
| Nine Months ended |
| ||||||||
|
| 2016 |
| 2015 |
| 2016 |
| 2015 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Basic and diluted net loss per common share calculation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
| $ | (3,120,939 | ) | $ | (2,316,316 | ) | $ | (11,883,392 | ) | $ | (9,668,040 | ) |
Weighted average common shares outstanding — basic and diluted |
|
| 84,177,838 |
|
| 86,013,196 |
|
| 84,043,124 |
|
| 81,853,065 |
|
Net loss per share of common stock — basic and diluted |
| $ | (0.04 | ) | $ | (0.03 | ) | $ | (0.14 | ) | $ | (0.12 | ) |
There are 3,500,000 shares in escrow, subject to cancellation, that have not been included in basic weighted average common shares outstanding for the three and nine months ended September 30, 2016 and 2015. (See Note 7. Stockholders’ Equity.)
The following outstanding securities at September 30, 2016 and 2015 have been excluded from the computation of diluted weighted average shares outstanding, as they would have been anti-dilutive:
|
| 2016 |
| 2015 |
| ||
|
|
|
|
|
| ||
Stock options |
|
| 2,470,000 |
|
| 150,000 |
|
Warrants |
|
| 967,418 |
|
| — |
|
Total |
|
| 3,437,418 |
|
| 150,000 |
|
Note 4. Property and Equipment, Net.
Property and equipment, net consisted of the following:
|
| September 30, 2016 |
| December 31, 2015 |
| ||
|
| (Unaudited) |
|
|
| ||
|
|
|
|
|
|
|
|
Machinery and equipment |
| $ | 21,463 |
| $ | 21,463 |
|
Less: accumulated depreciation |
|
| 11,783 |
|
| 8,585 |
|
|
| $ | 9,680 |
| $ | 12,878 |
|
Depreciation expense was $3,198 and $3,222 for the nine months ended September 30, 2016 and 2015, respectively.
- 9 -
Note 5. Accounts Payable and Other Current Liabilities.
Accounts payable and other current liabilities consisted of the following:
|
| September 30, 2016 |
| December 31, 2015 |
| ||
|
| (Unaudited) |
|
|
| ||
|
|
|
|
|
|
|
|
Legal |
| $ | 1,225,943 |
| $ | 781,933 |
|
Consulting |
|
| 60,007 |
|
| 50,947 |
|
Accounting and auditing |
|
| 307,511 |
|
| 157,129 |
|
Research and development |
|
| 249,307 |
|
| 241,259 |
|
Board of Directors and Scientific Advisory Board compensation |
|
| 337,500 |
|
| 225,000 |
|
Other |
|
| 67,530 |
|
| 18,063 |
|
|
| $ | 2,247,798 |
| $ | 1,474,331 |
|
Note 6. Debt.
Insurance Note Payable
The Company entered into an agreement to finance director and officer insurance premiums totaling $232,100 for the policy year ending in March 2017. The Company made a payment of $65,000 in April 2016 and, thereafter, payments will be made in eight equal installments of $21,274, inclusive of interest accruing at 3.99%.
As of September 30, 2016, the Company has a prepaid asset associated with the financing of insurance premiums of $122,008 included as part of current assets for the policy year ending in March 2017. This amount is equal to the total premiums of $232,100 offset by expense recognized through September 30, 2016 of $110,092.
Bridge Notes Payable
On July 11, 2014, Tyme received $1,100,000 in proceeds from the issuance of a convertible promissory note (the “Bridge Note”) from an affiliate of GEM Global Yield Fund, LLC SCS (“GEM”). The Bridge Note bears interest at a rate of 10% per year, maturing fifteen months from the date of issue and was secured by all assets of Tyme. The Bridge Note was mandatorily convertible into Company common stock upon the closing of the PPO. To secure certain obligations relating to the Bridge Note and the then proposed merger, Tyme issued in the name of the purchaser of the Bridge Note but placed into escrow shares of Company common stock. These shares were not deemed outstanding, but would either be delivered to the Bridge Note purchaser or returned to Tyme for cancellation pursuant to the terms of a Termination Shares Escrow Agreement, dated as of July 11, 2014, among Tyme, the purchaser of the Bridge Note and the escrow agent. Subsequently, such escrow concerning the Bridge Note was terminated in accordance with the applicable provisions of the Termination Shares Escrow Agreement, those shares of Company common stock were released by the escrow agent to the Company, and the Company then cancelled those shares of common stock.
On November 24, 2014, the purchaser of the Bridge Note loaned Tyme an additional $250,000. In connection with the funding of such loan, the Bridge Note was amended and restated to reflect a principal amount of $1,350,000.
On January 15, 2015, the purchaser of the Bridge Note loaned Tyme a further $960,000. In connection with the funding of such further loan, the Bridge Note was amended and restated to reflect a principal amount of $2,310,000. On March 5, 2015, the Bridge Note was further amended and restated to the effect that the mandatory conversion feature was amended to a set fixed conversion amount such that, upon mandatory conversion, the Bridge Note purchaser would receive one share of Company common stock (each, a “Bridge Note Conversion Share”) for each $1.00 of principal of the Bridge Note outstanding as of the date of the mandatory conversion. The Company evaluated the modification to the conversion rate as an inducement to convert the Bridge Note and concluded that it provided the purchaser of the Bridge Note an incremental value of $3,465,000, which is included as interest expense on the consolidated statement of operations for the nine months ended September 30, 2015.
The Company recorded interest expense of $0 and $38,301 during the three and nine months ended September 30, 2015 on the Bridge Note. The aggregate outstanding principal was converted into 2,310,000 Bridge Note Shares upon the closing of the Merger (See Note 1. Nature of Business and Basis of Presentation.)
- 10 -
Note 7. Stockholders’ Equity.
Preferred Stock
The Company is authorized to issue up to 10,000,000 shares of preferred stock, each with a par value of $0.0001. Shares of Company preferred stock may be issued from time to time in one or more series and/or classes, each of which will have such distinctive designation or title as shall be determined by the Company’s board of directors prior to the issuance of any shares of such series or class. The Company preferred stock will have such voting powers, full or limited or no voting powers and such preferences and relative, participating, optional or other special rights and such qualifications, limitations or restrictions thereof, as shall be stated in such resolution or resolutions providing for the issue of such series or class of Company preferred stock as may be adopted from time to time by the Company’s board of directors prior to the issuance of any shares thereof. No shares of Company preferred stock are currently issued or outstanding and the Company’s board of directors has not designated any class or series of Company preferred stock for use in the future.
Common Stock
Authorized, Issued and Outstanding
The Company is authorized to issue 300,000,000 shares of common stock, each with a par value of $0.0001, of which 87,677,838 shares were issued and outstanding at September 30, 2016 and 86,836,370 shares were issued and outstanding at December 31, 2015.
Voting
Each holder of Company common stock is entitled to one vote for each share thereof held by such holder at all meetings of stockholders (and written action in lieu of meetings). The number of authorized shares of Company common stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of majority of the combined number of issued and outstanding shares of the Company.
Dividends
Dividends may be declared and paid on the Company common stock from funds lawfully available therefore, as and when determined by the board of directors.
Liquidation
In the event of the liquidation, dissolution, or winding-up of the Company, holders of Company common stock will be entitled to receive all assets of the Company available for distribution to its stockholders.
Escrow shares
Pursuant to the Merger Agreement, the Pre-Merger Company stockholders would have had the opportunity to receive 1,333,333 shares of Company common stock in the event that the Company conducted an offering of at least $20,000,000 at a pre-money Company valuation between $200,000,000 and $400,000,000 with such offering proceeds placed in escrow on or before the date which was five months following the consummation of the Merger. As this offering did not occur, these 1,333,333 shares were not issued by the Company. The Merger Agreement further provided that, if the pre-money valuation on which the raised funds were placed into escrow was less than $200,000,000, or if no money was raised within such five month period, up to 3,500,000 shares of Company common stock were required to be surrendered for cancellation. Such 3,500,000 shares were placed into escrow pursuant to an Adjustment Shares Escrow Agreement entered into at the time of Merger Closing (the “Adjustment Shares Escrow Agreement”). The date on which the offering funds were required to be placed into escrow was extended under the terms of the Second Omnibus Amendment to November 5, 2015. No offering was consummated, nor were any offering funds placed into escrow. On November 10, 2015, the Company advised the escrow agent of such facts and demanded the surrender for cancellation of the 3,500,000 shares placed into escrow under the Adjustment Shares Escrow Agreement. Under the Adjustment Shares Escrow Agreement, the depositor of such escrowed shares had until November 18, 2015 to challenge the Company’s demand for surrender of the Escrowed Shares.
On November 17, 2015, the Company received notice from the depositor of such 3,500,000 shares disputing the grounds for the surrender for cancellation of those shares. Until resolved by court order or otherwise, the 3,500,000 shares shall remain in escrow.
- 11 -
On January 19, 2016, the Company filed a complaint against the depositor with the Commercial Division of the Supreme Court of New York, New York and on April 1, 2016, the Company filed an amended complaint, which asserts causes of actions for (i) a declaratory judgment declaring that the relevant contracts require the 3,500,000 escrowed Adjustment Shares to be released to the Company; (ii) breach of contract for failure to deliver the 3,500,000 escrowed Adjustment Shares to the Company; (iii) conversion for the depositors willful and malicious interference with the Company’s rights to the Adjustment Shares; and (iv) replevin for the escrow agent’s refusal to surrender the escrowed Adjustment Shares to the Company.
On June 20, 2016, the depositor filed their answer and asserted two counterclaims. The first counterclaim alleges that the Company purportedly breached its obligation to allow the depositor to provide additional financing by refusing to allow the depositor to purchase 17,200,000 shares at a price of $1.1626 per share. The depositor alleges that it was damaged by at least $144,000,000 based upon the differential between the depositor’s proposed share purchase price and the then-current market value of the Company’s Common stock. The depositor’s second counterclaim alleges that the Company purportedly breached its fiduciary duties to the depositor as a stockholder of the Company, by rejecting the depositor’s proposed financing described above. The Company believes the depositor’s counterclaims are without merit and intends to vigorously defend these claims and seek the return of the 3,500,000 escrowed Adjustment Shares in accordance with the terms set out in the Merger Agreement and the Adjustment Shares Escrow Agreement. The Company moved to dismiss the counterclaims on August 10, 2016, the depositor filed its opposition on September 21, 2016 and the Company filed its reply memorandum of law on October 28, 2016.
Registration Rights Agreement
In connection with the PPO, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with the purchaser in the PPO and the holder of the Bridge Note, pursuant to which the Company agreed to promptly, but no later than 90 days following the maturity date of the PPO Note (such maturity date initially being 90 calendar days after the closing of the PPO), file a registration statement with the SEC (the “Registration Statement”) covering (a) all of the PPO Shares issued in the PPO, (b) the Bridge Note Conversion Shares issued upon conversion of the Bridge Note, (c) the Lower Price Shares, if any, and (d) any shares of the Company common stock issued or issuable with respect to the PPO Shares, Conversion Shares and Lower Price Shares upon any stock split, dividend or other distribution, recapitalization or similar event. The Merger Agreement provided that the Registration Statement may also cover 9% of the total number of shares issued to the former stockholders of Tyme in connection with the Merger. The required filing date of the Registration Statement to avoid the imposition of liquidated damages was extended by an additional 31 days pursuant to the First Omnibus Amendment.
The Registration Rights Agreement was further modified by the Second Omnibus Amendment to the effect of (x) the holder of all of the PPO/Bridge Note Conversion Registrable Shares agreeing to irrevocably waive any right to damages for the late filing and/or effectiveness of the registration statement contemplated by the Registration Rights Agreement and (y) the total number of shares that can be registered by the former Tyme stockholders was increased to 15% of the total number of shares issued to them in connection with the Merger.
Securities Purchase Agreement
On February 2, 2016, pursuant to a Securities Purchase Agreement, for the aggregate consideration of $3,100,000, before deducting offering costs of $67,718, the Company sold and issued in a private placement an aggregate of: (i) 775,000 shares of the Company’s common stock, par value $0.0001 per share, and (ii) 461,384 common stock purchase warrants. Each Warrant entitles its holder to purchase one share of common stock at an initial exercise price of $5.00 at any time during the period commencing on February 2, 2016 and terminating on the tenth anniversary of such date. No registration rights were granted to the purchasers of these shares or warrants. The warrants are included within additional paid-in capital on the statement of stockholders’ equity and will not be subject to remeasurement.
Securities Issued for Services
On July 1, 2016, pursuant to a Securities Acquisition Agreement, dated as of June 29, 2016, the Company issued to a law firm, in satisfaction of $200,000 of payables due such law firm, an aggregate of (i) 50,000 shares of the Company’s common stock, par value $0.0001 per share, and (ii) 29,767 Warrants. Each Warrant entitles its holder to purchase one share of common stock at an initial exercise price of $5.00 at any time during the period commencing on June 29, 2016 and terminating on the tenth anniversary of such date. No registration rights were granted related to these shares or warrants. The warrants are included within additional paid-in capital on the statement of stockholders’ equity and will not be subject to remeasurement.
- 12 -
Derivative Liability
The investor in the PPO and the Bridge Note holder have been granted anti-dilution protection with respect to the PPO Shares and Bridge Note Conversion Shares such that, if within two years after the closing of the Merger, the Company shall issue additional shares of Company common stock or common stock equivalents, for a consideration per share less than $0.50 per share (the “Lower Price”), each such investor and holder will be entitled to receive from the Company additional shares (“Lower Price Shares”) of Company common stock in an amount such that, when added to the number of shares initially purchased by such investor or received upon conversion of the Bridge Note, will equal the number of shares that such investor’s PPO subscription amount would have purchased or the Bridge Note holder would have received upon conversion of the Bridge Note at the Lower Price. GEM was the sole investor in the PPO and designee of the Bridge Note holder who received the Bridge Note Conversion Shares.
The Company has determined that this anti-dilution protection is a freestanding financial instrument that will be carried as a liability at fair value. At the time of the merger, in the quarter ended March 31, 2015, management measured this derivative at fair value and recognized a derivative liability of $376,300 on the consolidated balance sheet, with the offset recorded against additional paid-in capital. The derivative is valued primarily using models based on unobservable inputs that represent management’s best estimate of what market participants would use in pricing the liability at the measurement date and thus are classified as Level 3. The model incorporates various assumptions related to the Company’s stock price and ascribes a probability based on management’s expectation that such assumptions would occur. Changes in the fair values of the derivative are recognized in earnings in the current period. As of December 31, 2015, the Company determined that the likelihood of the anti-dilution provisions being met was remote based on the Company’s current stock price and the length of time remaining until maturity, and therefore, the anti-dilution protection had no value. There have been no changes in the assumptions used at December 31, 2015 and therefore the derivative liability continues to have no value as of September 30, 2016.
Note 8. Commitments and Contingencies.
Contract Service Providers
In the course of the Company’s normal business operations, it enters into agreements and arrangements with contract service providers to assist in the performance of its research and development and clinical research activities. Substantially all of these agreements and arrangements are on an as needed basis.
Employment Agreement
On March 5, 2015, the Company entered into employment agreements with its Chief Executive Officer and Chief Operating Officer. Under these agreements, each of such two executive officers will be entitled to an annual base salary of $450,000 and such performance bonuses as the Company’s board of directors may determine, from time to time, in its sole discretion. The base salaries will be reviewed annually (commencing in 2016) by the Company’s board of directors; provided that the base salaries may not be decreased from their then current levels due to any board review. The employment agreements each have a term of five years; provided, however, that, commencing on the first anniversary of the dates of the agreements and on each anniversary thereafter, the term shall automatically be extended by one year, such that, at any time during the term of the agreement, the remaining employment term shall never be less than four years and one day. If employment is terminated by the Company without Cause or by the executive for Good Reason, the executive will be entitled to receive (i) base salary as in effect at the time of such termination to the extent such amount has accrued through the termination date and remains unpaid, (ii) any fully earned and declared but unpaid performance bonus as of the termination date, (iii) an amount equal to the sum of base salary the executive would have received from the date of such termination through the then applicable expiration date, which shall be payable in the same amounts and at the same intervals as if the employment period had not ended and (iv) any unpaid expenses as of the termination date. If the employment is terminated for “Cause,” or in the case of the executive’s death or disability, the executive will only be entitled to his base salary through the termination date, plus any accrued and unpaid performance bonus as of the termination date. On May 9, 2016, each of the Chief Executive Officer and the Chief Operating Officer received an option to purchase 500,000 shares vesting monthly over a 36-month period. The exercise price of this option was set at $8.75 per share.
- 13 -
The Company entered into a new employment arrangement, set forth in a letter agreement, dated as of January 27, 2016, with its Chief Financial Officer. The new employment arrangement supersedes the prior letter agreement with the Chief Financial Officer which was dated as of May 15, 2015. As part of the new employment agreement, as of March 31, 2016, the officer was granted a five year option to purchase up to 200,000 shares of the Company’s common stock at a per share purchase price of $11.00, the closing price of the common stock on the date of the new agreement. One-half of the shares subject to such option vested immediately upon grant and the remaining 100,000 shares subject to the option will vest on July 27, 2016, provided that the officer is still employed by the Company on said vesting date. The options granted on January 27, 2016 were cancelled on May 9, 2016 upon the issuance of a new award on that date. The May 9, 2016 award to the Chief Financial Officer provided for an option to purchase 500,000 shares, with the option for 300,000 shares fully vested as of the date of grant and the option for 200,000 shares vesting monthly over a 36-month period. The exercise price of this option was set at $8.75 per share.
Pursuant to a prior agreement, the Chief Financial Officer also was granted a five-year option to purchase 150,000 shares of Company common stock at $7.75 per share. The option vested with respect to 75,000 shares on November 15, 2015 and the remaining 75,000 shares vested on May 15, 2016 and remain exercisable in accordance with its terms.
On May 9, 2016, the board of directors of the Company approved an employment agreement with its Chief Medical Officer. The approved agreement provides for an annual salary of $400,000, a term which expired on October 31, 2016 and severance benefits payable in certain circumstances. The Board also approved a grant to the Chief Medical Officer of an option to purchase 500,000 shares of common stock vesting over a four-year term on a monthly basis. The exercise price of this option was set at $8.75 per share.
Legal Proceedings
Other than discussed below, the Company is not involved in any legal proceeding that it expects to have a material effect on its business, financial condition, results of operations or cash flows.
As described in Note 7. Stockholders’ Equity, the Merger Agreement further provided that, if the pre-money valuation on which the raised funds were placed into escrow was less than $200,000,000, or if no money was raised within such five month period, up to 3,500,000 shares of Company common stock were required to be surrendered for cancellation. Such 3,500,000 shares were placed into escrow pursuant to an Adjustment Shares Escrow Agreement entered into at the time of Merger Closing (the “Adjustment Shares Escrow Agreement”). The date on which the offering funds were required to be placed into escrow was extended under the terms of the Second Omnibus Amendment to November 5, 2015. No offering was consummated, nor were any offering funds placed into escrow by November 5, 2015. On November 10, 2015, the Company advised the escrow agent of such facts and demanded the surrender for cancellation of the 3,500,000 shares placed into escrow under the Adjustment Shares Escrow Agreement. Under the Adjustment Shares Escrow Agreement, the depositor of such escrowed shares had until November 18, 2015 to challenge the Company’s demand for surrender of the Escrowed Shares.
On November 17, 2015, the Company received notice from the depositor of such 3,500,000 shares disputing the grounds for the surrender for cancellation of those shares. Until resolved by court order or otherwise, the 3,500,000 shares shall remain in escrow.
On January 19, 2016, the Company filed a complaint against the depositor with the Commercial Division of the Supreme Court of New York, New York and on April 1, 2016, the Company filed an amended complaint, which asserts causes of actions for (i) a declaratory judgment declaring that the relevant contracts require the 3,500,000 escrowed Adjustment Shares to be released to the Company; (ii) breach of contract for failure to deliver the 3,500,000 escrowed Adjustment Shares to the Company; (iii) conversion for the depositors willful and malicious interference with the Company’s rights to the Adjustment Shares; and (iv) replevin for the escrow agent’s refusal to surrender the escrowed Adjustment Shares to the Company.
On June 20, 2016, the depositor filed their answer and asserted two counterclaims. The first counterclaim alleges that the Company purportedly breached its obligation to allow the depositor to provide additional financing by refusing to allow the depositor to purchase 17,200,000 shares at a price of $1.1626 per share. The depositor alleges that it was damaged by at least $144,000,000 based upon the differential between the depositor’s proposed share purchase price and the then-current market value of the Company’s Common stock. The depositor’s second counterclaim alleges that the Company purportedly breached its fiduciary duties to the depositor as a stockholder of the Company, by rejecting the depositor’s proposed financing described above. The Company believes the depositor’s counterclaims are without merit and intends to vigorously defend these claims and seek the return of the 3,500,000 escrowed Adjustment Shares in accordance with the terms set out in the Merger Agreement and the Adjustment Shares Escrow Agreement. The Company moved to dismiss the counterclaims on August 10, 2016, the depositor filed its opposition on September 21, 2016 and the Company filed its reply memorandum of law on October 28, 2016. See Part II, Item 1 of this report regarding litigation filed by Tyme Tech related to this matter.
- 14 -
Note 9. Related Party Transactions.
Due from Stockholders/Members
Effective as of the consummation of and in anticipation of the Merger, the non-interest bearing advances made to such stockholders/members was settled by the bonus compensation payments of $342,250 payable to such stockholders being retained by the Company in lieu of payment. The balance of $13,516 was settled during March 2015 by personal reimbursement made by the stockholders to the Company.
Sale of Excess Ingredient Materials
During the nine months ending September 30, 2016, Steve Hoffman, the Company’s President and Chief Executive Officer, purchased excess ingredient materials from the Company for a cost of $170,000, which was the pro rata cost of obtaining the items. The income from this was recorded as an offset to Research and Development expense on the Condensed Consolidated Statements of Operations, where the cost of such materials was originally recorded.
Note 10. Equity Incentive Plan.
On March 5, 2015, the Company’s Board of Directors adopted and the Company’s stockholders approved, the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). A reserve of 10,000,000 shares of Company common stock has been established for issuance under the 2015 Plan. No more than an aggregate of 3,333,333 shares of common stock may be awarded during the twelve months following the 2015 Plan adoption. Awards under the 2015 Plan may include, but need not be limited to, one or more of the following: options, stock appreciation rights, restricted stock, performance grants, stock bonuses, and any other type of award deemed by the administrator to be consistent with the purposes of the 2015 Plan. The exercise price of all options awarded under the 2015 Plan must be no less than 100% of the fair market value of the Company common stock on the date of the grant and have a term of no greater than ten years from the date of grant. As of September 30, 2016, there were 6,877,162 shares available for grant under the 2015 Plan.
Stock Options
As of September 30, 2016, there was $11,243,065 of total unrecognized compensation related to non-vested stock options. The cost is expected to be recognized over the remaining period of the options which are expected to vest through 2020. In addition to the grants described in Note 8 above, the Company has also granted options to certain of its employees as well as consultants working in an advisory capacity and the independent directors on its Board.
The Company uses the Black-Scholes option pricing model to determine the fair value of stock options granted. In accordance with ASC 718 for employees, the compensation expense is amortized on a straight-line basis over the requisite service period, which approximates the vesting period.
The expected volatility of options granted has been determined using the method described under ASC 718 using the expected volatility of similar companies. The expected term of options granted to employees in the current fiscal period has been based on the contractual term of the agreement as prescribed by ASC 718 Share-Based Payment.
The assumptions utilized to determine such values are presented in the following table:
| September 30, 2016 |
| September 30, 2015 |
| (Unaudited) |
| (Unaudited) |
|
|
|
|
Risk free interest rate | 1.77% |
| 1.65% |
Expected volatility | 80.00% |
| 82.90% |
Expected term | 10 years |
| 5 years |
Dividend yield | 0% |
| 0% |
- 15 -
The following is a summary of the status of the Company’s stock options as of September 30, 2016:
|
| Number of |
| Weighted Average |
| ||
|
|
|
|
|
|
|
|
Outstanding at December 31, 2015 |
|
| 150,000 |
| $ | 7.75 |
|
Granted |
|
| 2,520,000 |
|
| 8.74 |
|
Exercised |
|
| — |
|
| — |
|
Forfeited/Cancelled |
|
| (200,000 | ) |
| 11.00 |
|
Outstanding at September 30, 2016 |
|
| 2,470,000 |
|
| 8.49 |
|
Grant date fair value of options granted during the nine months ended September 30, 2016 |
| $ | 7.26 |
|
|
|
|
|
| Stock Options Outstanding |
| Stock Options Vested | ||||||||||
Range of |
| Number |
| Weighted |
| Weighted |
| Aggregate |
| Number |
| Weighted |
| Aggregate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$3.75 - $8.75 |
| 2,470,000 |
| $8.49 |
| 9.26 |
| $111,250 |
| 907,500 |
| $8.05 |
| $111,250 |
The intrinsic value is calculated as the excess of the market value of September 30, 2016 over the exercise price of the options.
Share-based compensation expense recognized was as follows (in thousands):
|
|
| Three Months Ended |
|
| Nine Months ended |
| ||||||
|
|
| 2016 |
|
| 2015 |
|
| 2016 |
|
| 2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
| $ | 549,552 |
| $ | — |
| $ | 1,238,604 |
| $ | — |
|
General and administrative |
|
| 584,922 |
|
| 193,500 |
|
| 5,156,120 |
|
| 292,355 |
|
|
| $ | 1,134,474 |
| $ | 193,500 |
| $ | 6,394,724 |
| $ | 292,355 |
|
Stock Grants
On March 10, 2015, the Company adopted an independent director compensation policy and also adopted a compensation policy with respect to a special advisor to the Company’s board of directors. Under such independent director compensation policy, each of those directors meeting the NASDAQ stock market definition of independent director is entitled to receive annual compensation in the amount of $100,000, one-half to be paid in cash on a quarterly basis, in arrears, and the remaining one-half of the compensation to be paid in the form of Company common stock on a quarterly basis, in arrears, with the shares valued at the closing sale price of the Company common stock on the last trading day of the applicable quarterly period. The special advisor was compensated in the same manner as the independent directors through the date the special advisor joined the Company’s board of directors (May 9, 2016). Additionally, effective as of September 30, 2015, the Company established a Scientific and Medical Advisory Board, and five individuals were appointed as members of such advisory board and a compensation policy for the advisory board’s members, substantially identical to the compensation policy for the Company’s independent directors, was adopted. At the end of 2015, one member of the Scientific and Medical Advisory Board became a full time employee of the Company and is no longer compensated as a member of the advisory board.
On May 9, 2016, the Company amended the independent director compensation policy. The independent directors will continue to receive $50,000 in cash annually. Pursuant to the amended compensation policy, the independent directors received an immediate stock option grant of 25,000 shares with an exercise price per share at fair market value ($8.75). Beginning with the Company’s 2017 annual meeting, members who are reelected as members of the Board will receive an annual stock option grant of 10,000 shares at fair market value. Each of these stock option awards will vest 50% on the date of grant and 50% on the first anniversary of the date of grant. These stock option awards are in addition to the annual payment of $50,000 in cash fees for the independent directors.
- 16 -
The Company issued to its three independent directors and special advisor an aggregate of 19,016 shares of Company common stock as compensation during the nine months ended September 30, 2015. The shares were valued using the $6.90 closing sale price of the Company common stock on the last trading day of the quarter ended March 31, 2015 and the $8.50 closing sale price of the Company common stock on the last trading day of the quarters ended June 30, 2015 and September 30, 2015, respectively. Total stock compensation expense related to these stock grants was $50,000 and $150,000 for the three and nine months ended September 30, 2015, respectively.
The Company issued to its five scientific advisory board members 7,355 shares of Company common stock as compensation during the nine months ended September 30, 2015. The shares were valued using the $8.50 closing sale price of the Company common stock on the last trading day of the quarter ended September 30, 2015. Total stock compensation expense related to these stock grants was $62,500 for the three and nine months ended September 30, 2015.
The Company issued 16,468 shares of Company common stock as compensation to its advisory board members during the nine months ended September 30, 2016. The shares were valued using the $6.05 and $6.10 closing sale price of the Company common stock on the last trading day of the quarters ended March 31, 2016, and June 30, 2016, respectively. Total compensation expense related to these stock grants was $50,000 and $100,000 for the three and nine months ended September 30, 2016.
No shares of Company common stock were issued to its three independent directors, special advisor and advisory board members as compensation for the three months ended September 30 2016, however, the Company has accrued additional compensation expense totaling $50,000 for the shares to be granted in accordance with the compensation policy.
Note 11. Subsequent Events.
The Company evaluates events or transactions that occur after the balance sheet date but prior to the issuance of consolidated financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. For its interim financial statements as of September 30, 2016 and for the three and nine months then ended, management of the Company determined that there were no reportable subsequent event(s) to be disclosed.
- 17 -
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing in our Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in our Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of our Annual Report on Form 10-K filed on March 30, 2016, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. As used in this report, unless the context suggests otherwise, “we,” “us,” “our,” “the Company” or “Tyme Technologies” refer to Tyme Technologies, Inc.
Overview
We were originally formed in Florida on November 22, 2011, to produce, market and sell an ultra-premium vodka product to retailers. We were not successful in our efforts and we turned our efforts towards seeking, investigating and, if such investigation warranted, engaging in a business combination with a private entity whose business presented an opportunity for our stockholders.
Effective as of September 18, 2014, we (then constituting a Florida corporation with the name Global Group Enterprises Corp.) reincorporated in the State of Delaware by merging into our wholly-owned Delaware subsidiary, Tyme Technologies, Inc., which was formed on August 22, 2014 specifically for this purpose (the “Reincorporation”). Tyme Technologies, Inc. was the surviving corporation in such merger. As a result of the Reincorporation, among other things, (i) we changed our name to Tyme Technologies, Inc., (ii) we changed our jurisdiction of incorporation from Florida to Delaware, (iii) we increased our authorized capital stock from 250,000,000 shares of common stock, $0.0001 par value per share, to 300,000,000 shares of common stock, $0.0001 par value per share, and 10,000,000 shares of preferred stock, $0.0001 par value per share, (iv) each share of Global Group Enterprises Corp.’s common stock outstanding at the time of the Reincorporation was automatically converted into 4.3334 shares of Tyme Technologies, Inc.’s common stock, with the result that the 12,000,000 shares of common stock outstanding immediately prior to the Reincorporation were converted into 52,000,800 shares of common stock outstanding immediately thereafter. All share and per share numbers in our Quarterly Report on Form 10-Q relating to our common stock prior to the Reincorporation have been adjusted to give effect to this conversion, unless otherwise stated. Subsequent to the Reincorporation, Global Group Enterprises Corp. ceased to exist.
As discussed in the notes to the condensed consolidated financial statements included in our Quarterly Report on Form 10-Q and in “Recent Developments” below, on March 5, 2015 we entered into a “reverse triangular merger” and related transactions with Tyme Inc., a Delaware corporation (“Tyme”), and other parties that resulted in, among other matters, a change in control of our Company and a change in our fiscal year from a fiscal year ending on November 30th of each calendar year to one ending on December 31st of each calendar year, which is the fiscal year basis for the financial statements presented herewith.
We are in the process of evaluating our short- and long-term financing requirements in order to effectuate our business plan. We anticipate that we will seek to raise required capital by the issuance of equity or debt securities, through private or public offerings or by other means. Our inability to raise necessary funds to conduct our planned operations could have a severe adverse effect on our ability to become a viable company. In addition, no assurance can be given that we will be able to obtain funds on favorable terms, if at all.
Recent Developments
In September 2015, we filed an Investigational New Drug Application (“IND”) with the FDA for our SM-88 drug candidate. In October 2015, the FDA accepted the IND and concluded that we may proceed with a clinical investigation of SM-88 for breast cancer. Subsequently, we made a determination, based on input from various sources and the strong interest of several clinical sites, to prioritize our clinical trial objectives by initiating a study in prostate cancer. On June 13, 2016, we announced that we have begun recruiting for a phase Ib/II clinical trial, using SM-88 to treat prostate cancer.
The trial will be a single-arm, open-label trial and up to five clinical sites will be involved. Prospective enrollees will have prostate cancer, rising PSA levels, without metastatic disease, and have failed androgen deprivation therapy. We will report results on PSA levels and novel biomarker components, as well as progression free survival data at the conclusion of the study, or earlier, if appropriate milestones are met. The Company is also evaluating the expansion of its phase II program to other types of cancer, including pancreatic cancer.
On March 5, 2015, we entered into and completed the Merger and associated transaction. For further details concerning these transactions, see the notes to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
- 18 -
As a result of the Split-Off Transaction and Merger, we discontinued our pre-Merger business and acquired the business of Tyme, a research and development company focused on developing drug candidates for the treatment of cancer in humans. We intend to continue the existing business operations of Tyme as our wholly-owned subsidiary. At the present time, we do not intend to operate any other business other than Tyme, although such operations may be conducted through one or more direct and/or indirect subsidiaries as we believe appropriate.
The transaction costs associated with the Merger relate to professional fees incurred in respect of legal, investor relations and accounting and audit of Tyme’s financial statements. All of such transaction costs, being associated with the final Merger, have been expensed as incurred and total approximately $1,000,000.
For accounting purposes, the acquisition of Tyme by our Company was considered a reverse acquisition, an acquisition transaction where the acquired company, Tyme, is considered the acquirer for accounting purposes, notwithstanding the form of the transaction. The primary reason the transaction was treated as a purchase by Tyme rather than a purchase by our Company was because we were a public reporting business combination shell company with limited operations and Tyme’s stockholders gained majority control of the outstanding voting power of our equity securities through their collective ownership of a majority of the outstanding shares of Company common stock. Consequently, reverse acquisition accounting was applied to the transaction. No goodwill or intangible assets were recognized in conjunction with the completion of the Merger.
Critical Accounting Policies and Significant Judgments and Estimates
This management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, revenue recognition, deferred revenue and stock-based compensation. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. There have been no significant changes in our critical accounting policies and significant judgments and estimates as discussed in our Form 10-K filed on March 30, 2016 with the SEC.
Results of Operations
Three and Nine Months Ended September 30, 2016 Compared to Three and Nine Months Ended September 30, 2015
Net loss for the three months ended September 30, 2016 was $3,120,939 compared to $2,316,316 for the three months ended September 30, 2015. Net loss for the nine months ended September 30, 2016 was $11,883,392 compared to $9,668,040 for the nine months ended September 30, 2015.
Revenues and Other Income
During the three and nine month periods ended September 30, 2016 and 2015, we did not realize any revenues from operations. We do not anticipate recognizing any revenues until such time as one of our products has been approved for marketing by appropriate regulatory authorities or we enter into collaboration or licensing arrangement, none of which is anticipated to occur in the near future.
Operating Costs and Expenses
For the three months ended September 30, 2016, operating costs and expenses totaled $3,120,939 compared to $2,316,316 for the three months ended September 30, 2015, representing an increase of $804,623. Operating costs and expenses were comprised of the following:
▪ | Research and development expenses were $1,130,468 for the three months ended September 30, 2016, compared to $1,357,394 for the three months ended September 30, 2015, representing a decrease of $226,926. All research and development expenditures have been incurred in respect of our lead drug candidate, SM-88, and its technology platform. Research and development activities primarily consist of the following: |
- 19 -
| ▪ | Salary expense for research and development personnel was $175,500 for the three months ended September 30, 2016, compared to $150,500 for the three months ended September 30, 2015, an increase of $25,000 between the comparable periods. This increase in 2016 expense is primarily attributable to a new hire. |
|
|
|
| ▪ | Consulting and study expenses were $306,415 for the three months ended September 30, 2016, compared to $525,344 for the three months ended September 30, 2015, representing a decrease of $218,929 between the comparable periods. These types of expenses are anticipated to vary between future accounting periods as we continue to develop our drug candidates and seek governmental approval of such drug candidates. |
|
|
|
| ▪ | For the three months ended September 30, 2016 we incurred cash and stock compensation expense totaling $50,000 related to the Scientific Advisory Board that was established as of September 30, 2015 compared to $125,000 for the three months ended September 30, 2015. This decrease is due to fewer Scientific Advisory Board members in the quarter ended September 30, 2016 and timing of stock issuances. |
|
|
|
| ▪ | Included in research and development expense for the three months ended September 30, 2016 is $549,552 of stock based compensation expense related to stock options granted to research and development personnel. No stock options were granted during or prior to the three months ended September 30, 2015 to research and development personnel. |
▪ | General and administrative expenses were $1,990,471 for the three months ended September 30, 2016, compared to $958,922 for the three months ended September 30, 2015, representing an increase of $1,031,549 with this increase principally attributed to the recognition of non-cash compensation expense related to stock options of $584,922 for the three months ended September 30, 2016. For the three months ended September 30, 2015, we had compensation expense totaling $193,500 related to stock options. The general and administrative expenses for the respective periods include: |
| ▪ | Salary expense for non-research and development personnel was $297,333 for the three months ended September 30, 2016, compared to $189,880 for the three months ended September 30, 2015, representing a $107,453 increase between the comparable periods. The increase is due to a new full time hire during 2016. |
|
|
|
| ▪ | Stock based compensation expense related to stock options granted was $584,922 for the three months ended September 30, 2016 compared to $193,500 for the three months ended September 30, 2015, representing an increase of $391,422 between the comparable periods. Stock options were granted to a larger population of executives and employees during the three months ended September 30, 2016 compared to only one non-research and development personnel stock option grant prior to the three months ending September 30, 2015. |
|
|
|
| ▪ | In addition, in the three months ended September 30, 2016, we incurred costs of $800,823 for legal and accounting fees compared to $303,749 for the three months ended September 30, 2015, representing an increase of $497,074. |
For the nine months ended September 30, 2016, operating costs and expenses totaled $11,883,392 compared to $6,164,739 for the nine months ended September 30, 2015, representing an increase of $5,718,653. Operating costs and expenses were comprised of the following:
▪ | Research and development expenses were $3,524,480 for the nine months ended September 30, 2016, compared to $2,662,403 for the nine months ended September 30, 2015, representing an increase of $862,007. All research and development expenditures have been incurred in respect of our lead drug candidate, SM-88, and its technology platform. Research and development activities primarily consist of the following: |
| ▪ | Salary expense for research and development personnel was $643,167 for the nine months ended September 30, 2016, compared to $592,972 for the nine months ended September 30, 2015, an increase of $50,195 between the comparable periods. The 2016 increase is primarily attributable to head count increases. |
|
|
|
| ▪ | Consulting and study expenses were $1,256,571 for the nine months ended September 30, 2016, compared to $1,298,386 for the nine months ended September 30, 2015, representing a decrease of $41,815 between the comparable periods. These types of expenses are anticipated to vary between future accounting periods as we continue to develop our drug candidates and seek governmental approval of such drug candidates. |
|
|
|
| ▪ | For the nine months ended September 30, 2016 we incurred cash and stock compensation expense totaling $100,000 related to the Scientific Advisory Board that was established as of September 30, 2015 compared to $125,000 for the nine months ended September 30, 2015. |
- 20 -
| ▪ | Included in research and development expense for the nine months ended September 30, 2016 is $1,238,604 of stock based compensation expense related to stock options granted to research and development personnel. No stock options were granted during or prior to the nine months ended September 30, 2015 to research and development personnel. |
▪ | General and administrative expenses were $8,358,912 for the nine months ended September 30, 2016, compared to $3,502,336 for the nine months ended September 30, 2015, representing an increase of $4,856,576. The general and administrative expenses for the respective periods include: |
| ▪ | Salary expense for non-research and development personnel was $767,597 for the nine months ended September 30, 2016, compared to $723,893 for the nine months ended September 30, 2015, representing a $43,704 increase between the comparable periods. The slight increase is due to the fact that during the nine months ended September 30, 2015, non-research and development personnel were awarded bonus compensation totaling $206,690 in connection with the Merger. This decrease is offset by a new full time hire during the nine months ended September 30, 2016. |
|
|
|
| ▪ | Stock based compensation expense related to stock options granted was $5,156,120 for the nine months ended September 30, 2016 compared to $292,355 for the nine months ended September 30, 2015, representing an increase of $4,863,765 between the comparable periods. Stock options were granted to a larger population of executives and employees during the nine months ended September 30, 2016 compared to only one non-research and development personnel stock option grant prior to the nine months ended September 30, 2015. |
|
|
|
| ▪ | In addition, in the nine months ended September 30, 2016, we incurred costs of $1,730,112 for legal and accounting fees compared to $1,079,533 for the nine months ended September 30, 2015, representing an increase of $650,579. |
|
|
|
| ▪ | Transaction costs associated with the Merger, which totaled approximately $1,000,000 for the nine months ended September 30, 2015 and relate to professional fees incurred in respect of legal, investor relations and accounting and auditing of Tyme’s financial statements. There were no such transaction costs incurred in the nine months ended September 30, 2016. |
Other income (expense)
There were no interest charges for the three and nine months ended September 30, 2016, compared to $0 and $3,503,301 for the three and nine months ended September 30, 2015, respectively. Contemporaneous with the closing of the Merger, the Bridge Note in the principal amount of $2,310,000 was converted into 2,310,000 shares of Company common stock. On March 5, 2015, the mandatory conversion feature of the Bridge Note was amended to a set fixed conversion amount such that, upon conversion, the Bridge Note purchaser would receive one share of Company common stock for each $1.00 of principal of the Bridge Note outstanding as of the date of the mandatory conversion. We evaluated the modification to the conversion rate as an inducement to convert the Bridge Note and concluded that it provided the purchaser of the Bridge Note an incremental value of $3,465,000, which is included as interest expense on the condensed consolidated statement of operations for the nine months ended September 30, 2015. No interest was recorded on the Bridge Note during the nine months ended September 30, 2016, compared to $38,301 for the nine months ended September 30, 2015.
Liquidity and Capital Resources
At September 30, 2016, we had cash of $3,079,796, working capital of $849,549 and stockholders’ equity of $859,229.
Net cash used in or provided by operating, investing and financing activities from continuing operations were as follows:
|
| Nine Months ended |
| ||||
|
| 2016 |
| 2015 |
| ||
|
|
|
|
|
|
|
|
Net cash used in operating activities |
| $ | (4,271,127 | ) | $ | (4,945,474 | ) |
Net cash used in investing activities |
|
| — |
|
| — |
|
Net cash provided by financing activities |
|
| 2,904,639 |
|
| 6,830,716 |
|
- 21 -
Operating Activities
Our cash used in operating activities in the nine months ended September 30, 2016 totaled $4,271,127 which is the sum of (i) our net loss of $11,883,392 less non-cash expenses totaling $6,697,922 (principally stock-based compensation), and (ii) changes in operating assets and liabilities of $914,343.
Our cash used in operating activities in the nine months ended September 30, 2015 totaled $4,945,474, which is the sum of (i) our net loss of $9,668,040, less non-cash expenses totaling $4,598,077 (principally the issuance of common stock for services and the non-cash conversion of Bridge Notes to Common Stock), and (ii) changes in operating assets and liabilities of $124,489.
Investing Activities
We had no net cash used in investing activities for the nine months ended September 30, 2016 and 2015.
Financing Activities
During the nine months ended September 30, 2016, our financing activities consisted of the following:
▪ | On February 2, 2016, pursuant to a Securities Purchase Agreement, for the aggregate consideration of $3,100,000, before deducting offering costs of $67,718, the Company sold and issued in a private placement an aggregate of: (i) 775,000 shares of the Company’s common stock, par value $0.0001 per share, and (ii) 461,384 common stock purchase warrants. |
|
|
▪ | Insurance notes payments were made totaling $127,643. |
During the nine months ended September 30, 2015, our financing activities consisted of the following:
▪ | Contemporaneous with the closing of the Merger, the Company completed a private placement of 2,716,000 shares of Company common stock for gross proceeds of $6,790,000 (of which, $4,265,000 was tendered in cash and the remaining subscription price paid by the delivery of the three-month PPO Note in the principal amount of $2,500,000). |
|
|
▪ | We raised gross proceeds of $960,000 through the additional funding under and the corresponding amendment and restatement of the Bridge Note. |
|
|
▪ | We received $1,250,000 from the partial collection of the stock subscription receivable representing 50% of the principal amount of the PPO Note. |
|
|
▪ | In 2014, Tyme and Luminant granted cash advances totaling $355,766 to certain of their then stockholders/members. Effective as of the consummation of the Merger during the nine months ended September 30, 2015, these non-interest bearing advances were settled. |
Liquidity and Capital Requirements Outlook
Liquidity
We anticipate requiring additional capital in order to fund the development of our product candidates, as well as to engage in strategic transactions. The most significant funding needs are anticipated to be in connection with preparing for and conducting one or more phase II clinical trials of our SM-88 drug candidate and related studies and investigations.
To meet our short and long-term liquidity needs, we currently expect to use existing cash balances and a variety of other means, including potential issuances of debt or equity securities in public or private financings, option exercises, and partnerships and/or collaborations. The demand for the equity and debt of biopharmaceutical companies like ours is dependent upon many factors, including the general state of the financial markets. During times of extreme market volatility, capital may not be available on favorable terms, if at all. Our inability to obtain such additional capital could materially and adversely affect our business operations. In addition, we expect to seek as appropriate grants for scientific and clinical studies. There can be no assurance that we will be successful in qualifying for or obtaining such grants.
- 22 -
We believe that our cash balances as of September 30, 2016 will be sufficient to fund the business through the next seven to nine months.
While we will continue to seek capital through a number of means, there can be no assurance that additional financing will be available on acceptable terms, if at all, and our negotiating position in capital generating efforts may worsen as existing resources are used.
Additional equity financing may be dilutive to our stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict our ability to operate as a business; and our stock price may not reach levels necessary to induce option exercises. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may have to delay or discontinue the development of our drug candidates or raise funds on terms that we currently consider unfavorable. These factors raise substantial doubt about our ability to continue as a going concern.
Seasonality
The Company does not believe that its operations are seasonal in nature.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.
Item 3. Quantitative and Qualitative Disclosures About Market Risks.
The primary objective of our investment activities is to preserve capital while at the same time maximizing yields without significantly increasing risk. Our cash balance as of September 30, 2016 was held in insured depository accounts, of which approximately $2,835,878 exceeded insurance limits.
Item 4. Controls and Procedures.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2016 as required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officer to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Based on the evaluation of our disclosure controls and procedures as of September 30, 2016, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were not effective for the reasons set forth below.
The matters involving internal controls and procedures that our management considered to be material weaknesses under the standards of the Public Company Accounting Oversight Board were:
• | lack of a functioning audit committee resulting in ineffective oversight in the establishment and monitoring of required internal controls and procedures; |
|
|
• | inadequate segregation of duties consistent with control objectives; and |
|
|
• | ineffective controls over period end financial disclosure and reporting processes. |
- 23 -
The aforementioned material weaknesses were identified by Messrs. Hoffman, Demurjian and Dickey in connection with their review of our financial statements as of September 30, 2016. In addition, our management noted further control and procedures deficiencies, including those relating to segregation of duties over cash disbursements and the prompt analysis of the financial impact of all transactions to which we are a party.
Our management believes that the material weaknesses set forth above did not have an effect on our financial results.
Management’s Remediation Initiatives
In an effort to remediate the identified material weaknesses and other deficiencies and enhance our internal controls, we have initiated, or plan to initiate, the following series of measures:
• | Assuming we are able to secure additional working capital, we will create additional positions in order to segregate duties consistent with control objectives and will increase our personnel resources and technical accounting expertise within the accounting function. Beginning in our fiscal quarter ended September 30, 2015, we retained an accounting and financial reporting advisory firm with significant experience with publicly held companies to assist management in the accounting function and in implementing and enhancing our internal controls over financial reporting. |
|
|
• | We intend to design and implement centralized and automated enhancements to the processing of invoices to assure standardized supplier setup and proper entry by invoice type into our accounts payable system. These enhancements will also incorporate adherence to signing authorities as part of check run processing and ensure the completion of timely month end reconciliation procedures for accounts payable and accrued expenses. |
|
|
• | Effective October 27, 2016, we formed an audit committee consisting of our three independent members of our board of directors. |
Changes in Internal Control over Financial Reporting
As noted above, we recently formed an audit committee. We anticipate that such audit committee will discuss with management, including our Chief Financial Officer, and our independent registered public accounting firm, the status of our financial controls and procedures and determine what changes are necessary to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with US GAAP. We anticipate that a number of changes in our financial controls and procedures will be made in the ensuing periods.
PART II – OTHER INFORMATION
Item 1. Legal Proceedings.
Except as set forth below, we are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on us, our business, operating results or financial condition.
On March 5, 2015, we, our wholly-owned subsidiary formed for the purposes of completing the merger (which we refer to as “Acquisition Sub”), Tyme, Inc. (“Tyme”) and certain other parties entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”). Simultaneous with the execution of the Merger Agreement, we and the other parties to the Merger Agreement consummated the transactions contemplated by the Merger Agreement (the “Merger”). We refer to the date that the transactions contemplated by the Merger Agreement, including the Merger, were consummated as the “Closing Date.” Pursuant to the terms of the Merger Agreement, Acquisition Sub merged with and into Tyme. Tyme was the surviving corporation in the Merger and thus became our wholly-owned subsidiary.
The Merger Agreement provided that, in the event we raised additional capital in a public or private offering (in one or more closings) for gross proceeds of at least $20 million (a “Qualified Offering”), based on a pre-money valuation of our Company of at least $200 million, within five months of the earlier two dates specified in the Merger Agreement, as amended and subject to certain conditions (with such date being referred to as the “Qualified Offering Trigger Termination Date”), the holders of record of our Common Stock as of the Closing Date (the “Pre-Merger Company Stockholders”) would have the opportunity to receive, pro rata, 1,333,333 additional restricted shares of our Common Stock (the “Qualified Offering Shares”).
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The Merger Agreement further provided that:
| · | if the pre-money valuation of our Company upon a Qualified Offering is $150 million or more but less than $200 million, the Pre-Merger Company Stockholders will surrender to us for cancellation without consideration 1 million shares of our Common Stock; |
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| · | if the pre-money valuation of our Company upon a Qualified Offering is $100 million or more but less than $150 million, the Pre-Merger Company Stockholders will surrender to us for cancellation without consideration 2 million shares of our Common Stock; and |
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| · | if the pre-money valuation of the Company upon a Qualified Offering is less than $100 million (which Qualified Offering may be rejected in the Company’s sole and absolute discretion) or if no Qualified Offering occurs within five months of the Qualified Offering Trigger Termination Date, the Pre-Merger Company Stockholders would be obligated to surrender to us for cancellation without consideration 3.5 million shares of our Common Stock. |
The Pre-Merger Company Stockholders previously placed into escrow pursuant to an escrow agreement (the “Adjustment Shares Escrow Agreement”), 3.5 million shares of our Common Stock (the “Adjustment Shares”) to secure such surrender obligations described above.
We had the sole authority to determine all matters relating to the Qualified Offering, including the subscription price, pre-money valuation and whether or not to accept any subscriber’s subscription offer. No Qualified Offering occurred by the Qualified Offering Trigger Termination Date and we have sought a return of the Adjustment Shares from the escrow under the Adjustment Shares Escrow Agreement.
On November 10, 2015, we made demand of the escrow agent holding the Adjustment Shares for their surrender for cancellation. On November 17, 2015, GEM Global Yield Fund LLC SCS (“GEM”), as depositor and on behalf of the Pre-Merger Company Stockholders, challenged such demand.
On January 19, 2016, we filed a complaint against GEM with the Commercial Division of the Supreme Court of New York, New York, captioned Tyme Technologies, Inc. v. GEM Global Yield Fund LLC SCS and CKR Law LLP, Index No. 650250/2016. On April 1, 2016, we filed an Amended Complaint. The Amended Complaint asserts causes of actions for (i) a declaratory judgment declaring that the relevant contracts require the 3.5 million escrowed Adjustment Shares to be released to us; (ii) breach of contract for failure to deliver the 3.5 million escrowed Adjustment Shares to us; (iii) conversion for GEM’s willful and malicious interference with Tyme Technologies’ rights to the Adjustment Shares; and (iv) replevin for CKR Law’s refusal to surrender the escrowed Adjustment Shares to us.
On June 20, 2016, the depositor filed their answer and asserted two counterclaims. The first counterclaim alleges that the Company purportedly breached its obligation to allow the depositor to provide additional financing by refusing to allow the depositor to purchase 17,200,000 shares at a price of $1.1626 per share. The depositor alleges that it was damaged by at least $144,000,000 based upon the differential between the depositor’s proposed share purchase price and the then-current market value of the Company’s Common stock. The depositor’s second counterclaim alleges that the Company purportedly breached its fiduciary duties to the depositor as a stockholder of the Company, by rejecting the depositor’s proposed financing described above. The Company believes the depositor’s counterclaims are without merit and intends to vigorously defend these claims and seek the return of the 3,500,000 escrowed Adjustment Shares in accordance with the terms set out in the Merger Agreement and the Adjustment Shares Escrow Agreement. The Company moved to dismiss the counterclaims on August 10, 2016, the depositor filed its opposition on September 21, 2016 and the Company filed its reply memorandum of law on October 28, 2016.
Item 1A. Risk Factors.
There have been no material changes to the risk factors disclosed in the Part 1, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC on March 30, 2016. Such risk factors are relevant in evaluating our business, financial position, future results and prospects. The risks described in our Annual Report on Form 10-K are not the only risks we face. Additional risks that we do not presently know or that we currently believe are immaterial could also materially and adversely affect any of our business, financial position, future results or prospects.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None during the quarter ended September 30, 2016.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
Item 6. Exhibits.
In reviewing the agreements included or incorporated by reference as exhibits to our Quarterly Report on Form 10-Q, please remember that they are included to provide the reader with information regarding their terms and are not intended to provide any other factual or disclosure information about our Company or the other parties to the agreements. The agreements may contain representations and warranties by each of the parties to the applicable agreement. These representations and warranties have been made solely for the benefit of the parties to the applicable agreement and:
• | should not in all instances be treated as categorical statements of fact, but rather as a way of allocating the risk to one of the parties if those statements prove to be inaccurate; |
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• | have been qualified by disclosures that were made to the other party in connection with the negotiation of the applicable agreement, which disclosures are not necessarily reflected in the body of the as-filed agreement; |
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• | may apply standards of materiality in a way that is different from what may be viewed as material to readers of this Form 10-Q or other investors; and |
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• | were made only as of the date of the applicable agreement or such other date or dates as may be specified in the agreement and are subject to more recent developments. |
Accordingly, such representations and warranties may not describe the actual state of affairs as of the date they were made or at any other time. Additional information about our Company may be found elsewhere in this Form 10-Q and our other public filings, which are available without charge through the SEC’s website at http://www.sec.gov.
Exhibit | Description |
31.1* | Rule 13(a)-14(a)/15(d)-14(a) Certification of Principal Executive Officer. |
31.2* | Rule 13(a)-14(a)/15(d)-14(a) Certifications of Principal Financial Officer. |
32.1* | |
32.2* | |
101.INS* | XBRL Instance Document. |
101.SCH* | XBRL Schema Document. |
101.CAL* | XBRL Calculation Linkbase Document. |
101.DEF* | XBRL Definition Linkbase Document. |
101.LAB* | XBRL Label Linkbase Document. |
101.PRE* | XBRL Presentation Linkbase Document. |
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* Filed Herewith.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Dated: November 9, 2016
| TYME TECHNOLOGIES, INC. |
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| By: | /s/ Steve Hoffman |
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| Steve Hoffman |
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| President and |
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| Chief Executive Officer |
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| (Principal Executive Officer) |
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| By: | /s/ Robert Dickey IV |
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| Robert Dickey IV |
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| Vice-President - Finance and |
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| Chief Financial Officer |
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| (Principal Financial Officer) |
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