Innovation Pharmaceuticals Inc. - Quarter Report: 2019 December (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: December 31, 2019
¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ____________to _____________
Commission File Number: 001-37357
INNOVATION PHARMACEUTICALS INC. |
(Exact name of registrant as specified in its charter) |
Nevada |
| 30-0565645 |
(State or other jurisdiction of |
| (I.R.S. Empl. Ident. No.) |
incorporation or organization) |
301 Edgewater Place - Suite 100
Wakefield, MA 01880
(Address of principal executive offices, Zip Code)
(978) 921-4125
(Registrant’s telephone number, including area code)
100 Cummings Center, Suite 151-B
Beverly, MA 01915
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act: None.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 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 ¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer | ¨ | Accelerated Filer | ¨ |
Non-Accelerated Filer | x | Smaller reporting company | x |
| Emerging growth company | ¨ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
The number of shares outstanding of each of the issuer’s classes of common equity, as of February 8, 2020 is as follows:
Class of Securities |
| Shares Outstanding |
Common Stock Class A, $0.0001 par value |
| 230,017,069 |
Common Stock Class B, $0.0001 par value |
| 909,090 |
INNOVATION PHARMACEUTICALS INC.
FORM 10-Q
For the Quarter Ended December 31, 2019
PART I – FINANCIAL INFORMATION
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2 |
Table of Contents |
FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words “intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,” “believes,” “should,” “could,” “may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. These forward-looking statements include, but are not limited to, any statements regarding our future financial performance, results of operations or sufficiency of capital resources to fund our operating requirements; statements relating to potential licensing, partnering or similar arrangements concerning our drug compounds; statements concerning our future drug development plans and projected timelines for the initiation and completion of preclinical and clinical trials; the potential for the results of ongoing preclinical or clinical trials; other statements regarding our future product development and regulatory strategies, including with respect to specific indications; and any other statements which are other than statements of historical fact. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include, but are not limited to, our ability to continue as a going concern and our capital needs; our ability to fund and successfully progress internal research and development efforts and to create effective, commercially-viable drugs; our ability to effectively and timely conduct clinical trials; our ability to ultimately distribute our drug candidates; our ability to achieve certain future regulatory, development and commercialization milestones under our license agreement with Alfasigma S.p.A.; and compliance with regulatory requirements, as well as other factors described elsewhere in this report and our other reports filed with the Securities and Exchange Commission (the “SEC”). Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
Forward-looking statements speak only as of the date on which they are made. Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the SEC that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business. Readers are cautioned not to put undue reliance on forward-looking statements.
For further information about these and other risks, uncertainties and factors, please review the disclosure included in our Annual Report on Form 10-K under “Part I, Item 1A, Risk Factors” and in this report under “Part II, Item 1A, Risk Factors.”
3 |
Table of Contents |
INNOVATION PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
AS OF DECEMBER 31, 2019 AND JUNE 30, 2019
(Unaudited)
(Rounded to nearest thousand except for shares data)
|
| December 31, |
|
| June 30, |
| ||
|
| 2019 |
|
| 2019 |
| ||
ASSETS | ||||||||
Current Assets: |
|
|
|
|
|
| ||
Cash |
| $ | 187,000 |
|
| $ | 579,000 |
|
Prepaid expenses and other current assets |
|
| 29,000 |
|
|
| 46,000 |
|
Total Current Assets |
|
| 216,000 |
|
|
| 625,000 |
|
Other Assets: |
|
|
|
|
|
|
|
|
Patent costs - net |
|
| 3,201,000 |
|
|
| 3,342,000 |
|
Property, plant and equipment -net |
|
| - |
|
|
| 1,000 |
|
Security deposit |
|
| 78,000 |
|
|
| 78,000 |
|
Total Other Assets |
|
| 3,279,000 |
|
|
| 3,421,000 |
|
Total Assets |
| $ | 3,495,000 |
|
| $ | 4,046,000 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIENCY | ||||||||
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable - (including related party payables of approx. $1,511,000 and $1,511,000, respectively) |
| $ | 2,285,000 |
|
| $ | 2,127,000 |
|
Accrued expenses - (including related party accruals of approx. $75,000 and $45,000, respectively) |
|
| 120,000 |
|
|
| 85,000 |
|
Accrued salaries and payroll taxes -(including related party accrued salaries of approx. $3,282,000 and $3,129,000, respectively) |
|
| 3,358,000 |
|
|
| 3,162,000 |
|
Operating lease current liability |
|
| 126,000 |
|
|
| - |
|
Note payable - related party |
|
| 1,922,000 |
|
|
| 1,922,000 |
|
Total Current Liabilities |
|
| 7,811,000 |
|
|
| 7,296,000 |
|
Other Liabilities: |
|
|
|
|
|
|
|
|
Series B 5% convertible preferred stock liability at $1,080 stated value; 1,440 and 1,196 shares issued and outstanding at December 31, 2019 and June 30, 2019, respectively |
|
| 812,000 |
|
|
| 879,000 |
|
Operating lease long term liability |
|
| 489,000 |
|
|
| - |
|
Total Liabilities |
|
| 9,112,000 |
|
|
| 8,175,000 |
|
Commitments and contingencies (Note 9) |
|
|
|
|
|
|
|
|
Stockholders’ Deficiency |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 designated shares, no shares issued and outstanding |
|
| - |
|
|
| - |
|
Common Stock - Class A, $0.0001 par value, 600,000,000 shares and 300,000,000 shares authorized, as of December 31, 2019 and June 30, 2019, respectively, 219,211,111 shares and 202,860,141 shares issued as of December 31, 2019 and June 30, 2019, respectively, 218,551,663 shares and 202,631,923 shares outstanding as of December 31, 2019 and June 30, 2019, respectively |
|
| 22,000 |
|
|
| 21,000 |
|
Common Stock - Class B, (10 votes per share); $.0001 par value, 100,000,000 shares authorized, 909,090 shares and 909,090 shares issued and outstanding as of December 31, 2019 and June 30, 2019, respectively |
|
| - |
|
|
| - |
|
Additional paid-in capital |
|
| 93,278,000 |
|
|
| 90,537,000 |
|
Accumulated deficit |
|
| (98,771,000 | ) |
|
| (94,596,000 | ) |
Treasury Stock, at cost (659,448 shares and 228,218 shares as of December 31, 2019 and June 30, 2019, respectively) |
|
| (146,000 | ) |
|
| (91,000 | ) |
Total Stockholders’ Deficiency |
|
| (5,617,000 | ) |
|
| (4,129,000 | ) |
Total Liabilities and Stockholders’ Deficiency |
| $ | 3,495,000 |
|
| $ | 4,046,000 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements
4 |
Table of Contents |
INNOVATION PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS AND SIX MONTHS ENDED DECEMBER 31, 2019 AND 2018
(Unaudited)
(Rounded to nearest thousand except for shares and per share data)
|
| For the three Months Ended |
|
| For the Six Months Ended |
| ||||||||||
|
| December 31, |
|
| December 31, |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| 2019 |
|
| 2018 |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Revenues |
| $ | - |
|
| $ | - |
|
| $ | 400,000 |
|
| $ | - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
| 806,000 |
|
|
| 1,399,000 |
|
|
| 1,609,000 |
|
|
| 2,756,000 |
|
General and administrative expenses |
|
| 354,000 |
|
|
| 432,000 |
|
|
| 619,000 |
|
|
| 692,000 |
|
Officers’ payroll and payroll tax expenses |
|
| 118,000 |
|
|
| 118,000 |
|
|
| 236,000 |
|
|
| 241,000 |
|
Professional fees |
|
| 67,000 |
|
|
| 45,000 |
|
|
| 222,000 |
|
|
| 304,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
| 1,345,000 |
|
|
| 1,994,000 |
|
|
| 2,686,000 |
|
|
| 3,993,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
| (1,345,000 | ) |
|
| (1,994,000 | ) |
|
| (2,286,000 | ) |
|
| (3,993,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
| - |
|
|
| 40,000 |
|
|
| - |
|
|
| 40,000 |
|
Interest expense – debt |
|
| (48,000 | ) |
|
| (50,000 | ) |
|
| (96,000 | ) |
|
| (101,000 | ) |
Interest expense – preferred stock liability |
|
| (20,000 | ) |
|
| (1,975,000 | ) |
|
| (40,000 | ) |
|
| (1,975,000 | ) |
Change in fair value of preferred stock |
|
| - |
|
|
| - |
|
|
| 102,000 |
|
|
| - |
|
Warrants modification expense |
|
| (1,212,000 | ) |
|
| - |
|
|
| (1,212,000 | ) |
|
| - |
|
Impairment expense of operating lease |
|
| - |
|
|
| - |
|
|
| (643,000 | ) |
|
| - |
|
Other expense, net |
|
| (1,280,000 | ) |
|
| (1,985,000 | ) |
|
| (1,889,000 | ) |
|
| (2,036,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision for income taxes |
|
| (2,625,000 | ) |
|
| (3,979,000 | ) |
|
| (4,175,000 | ) |
|
| (6,029,000 | ) |
Provision for income taxes |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
| $ | (2,625,000 | ) |
| $ | (3,979,000 | ) |
| $ | (4,175,000 | ) |
| $ | (6,029,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to common stockholders |
| $ | (0.01 | ) |
| $ | (0.02 | ) |
| $ | (0.02 | ) |
| $ | (0.04 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares |
|
| 214,073,575 |
|
|
| 170,541,226 |
|
|
| 209,925,208 |
|
|
| 166,912,770 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
5 |
Table of Contents |
INNOVATION PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIENCY
FOR THE SIX MONTHS ENDED DECEMBER 31, 2019 AND 2018
(Unaudited)
(Rounded to nearest thousand, except for shares data)
For the Six Months Ended December 31, 2018 | ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
|
| Common Stock A |
|
| Common Stock B |
|
|
|
|
|
|
|
|
|
|
|
| |||||||||||||||||||
|
|
|
|
| Par Value |
|
|
|
|
| Par Value |
|
| Additional Paid-in |
|
| Accumulated |
|
| Treasury Stock |
|
|
|
| ||||||||||||
|
| Shares |
|
| $0.0001 |
|
| Shares |
|
| $0.0001 |
|
| Capital |
|
| Deficit |
|
| Shares |
|
| Amount |
|
| Total |
| |||||||||
Balance at June 30, 2018 |
|
| 163,103,927 |
|
| $ | 17,000 |
|
|
| - |
|
| $ | - |
|
| $ | 83,747,000 |
|
| $ | (85,915,000 | ) |
|
| - |
|
| $ | - |
|
| $ | (2,151,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued to consultant for services at $0.84 - $1.38 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 3,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 3,000 |
|
Shares issued to officer as equity awards at $0.398 to $0.705 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 112,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 112,000 |
|
Stock options issued to consultant for services at $0.43 - $0.73 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 10,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 10,000 |
|
Stock options issued to officer as equity awards at $0.398 to $0.705 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 60,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 60,000 |
|
Issuance of 572,264 shares to Officer and employee |
|
| 572,264 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Shares issued to employee for services at $0.398 - $1.37 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 12,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 12,000 |
|
Stock options issued to employee for services at $0.398 - $1.37 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 32,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 32,000 |
|
Net loss for the three months ended 9/30/2018 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
|
| (2,050,000 | ) |
|
| - |
|
|
| - |
|
|
| (2,050,000 | ) |
Balance at September 30, 2018 |
|
| 163,676,191 |
|
| $ | 17,000 |
|
|
| - |
|
| $ | - |
|
| $ | 83,976,000 |
|
| $ | (87,965,000 | ) |
|
| - |
|
| $ | - |
|
| $ | (3,972,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued to consultant for services at $0.84 - $1.38 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 2,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 2,000 |
|
Shares issued to officer as equity awards at $0.398 to $0.705 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 148,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 148,000 |
|
Stock options issued to consultant for services at $0.43 - $0.73 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 10,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 10,000 |
|
Stock options issued to officer as equity awards at $0.398 to $0.705 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 78,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 78,000 |
|
Issuance of 533,334 shares to Officer & 218,946 shares were withheld for tax purposes as Treasury shares, so net issuance was 314,387 shares |
|
| (218,946 | ) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 218,946 |
|
|
| (87,000 | ) |
|
| (87,000 | ) |
Issuance of 38,930 shares to employee, 9,272 shares were withheld for tax purposes as Treasury shares, so net issuance was 29,658 shares |
|
| (9,272 | ) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 9,272 |
|
|
| (4,000 | ) |
|
| (4,000 | ) |
Issuance of 12,500 shares to Consultant |
|
| 12,500 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Conversion of 1,310 preferred stocks to 12,808,388 common stock |
|
| 12,808,388 |
|
|
| 1,000 |
|
|
| - |
|
|
| - |
|
|
| (1,000 | ) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Offering cost for Q2-2019 |
|
| - |
|
|
| - |
|
|
|
|
|
|
|
|
|
|
| (159,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
| (159,000 | ) |
To record underlying Series 1, Series 2 and Series 3 Warrants attached to 2000 shares Series B Preferred Stock |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 817,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 817,000 |
|
To record beneficial conversion feature of Series B preferred stock & warrants discounts |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 1,917,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 1,917,000 |
|
Transfer of the related preferred stock liability to APIC |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 963,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 963,000 |
|
Allocating warrants (proportion of value exercised) to Pref Stock Liability |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| (20,000 | ) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| (20,000 | ) |
Shares issued to employee for services at $0.398 - $1.37 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 15,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 15,000 |
|
Stock options issued to employee for services at $0.398 - $1.37 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 34,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 34,000 |
|
Net loss for the three months ended 12/31/2018 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
|
| (3,979,000 | ) |
|
| - |
|
|
| - |
|
|
| (3,979,000 | ) |
Balance at December 31, 2018 |
|
| 176,268,861 |
|
| $ | 18,000 |
|
|
| - |
|
| $ | - |
|
| $ | 87,780,000 |
|
| $ | (91,944,000 | ) |
|
| 228,218 |
|
| $ | (91,000 | ) |
| $ | (4,237,000 | ) |
6 |
Table of Contents |
For the Six Months Ended December 31, 2019 | ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
|
| Common Stock A |
|
| Common Stock B |
|
|
|
|
|
|
|
|
|
|
|
| |||||||||||||||||||
|
|
|
|
| Par Value |
|
|
|
|
| Par Value |
|
| Additional Paid-in |
|
| Accumulated |
|
| Treasury Stock |
|
|
|
| ||||||||||||
|
| Shares |
|
| $0.0001 |
|
| Shares |
|
| $0.0001 |
|
| Capital |
|
| Deficit |
|
| Shares |
|
| Amount |
|
| Total |
| |||||||||
Balance at June 30, 2019 |
|
| 202,631,923 |
|
| $ | 21,000 |
|
|
| 909,090 |
|
| $ | - |
|
| $ | 90,537,000 |
|
| $ | (94,596,000 | ) |
|
| 228,218 |
|
| $ | (91,000 | ) |
| $ | (4,129,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options issued to officer as equity awards at $0.398 to $0.705 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 65,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 65,000 |
|
Shares issued to officer as equity awards at $0.398 to $0.705 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 124,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 124,000 |
|
Stock options issued to employee for services at $0.398 - $1.37 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 28,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 28,000 |
|
Shares issued to employee for services at $0.398 - $1.37 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 10,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 10,000 |
|
Stock options issued to consultant for services at $0.43 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 6,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 6,000 |
|
Shares issued to consultant for services at $0.43 - $0.73 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 3,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 3,000 |
|
Issuance of 12,500 shares to Consultant |
|
| 12,500 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Issuance of 1,066,667 shares to Officer & 421,611 shares were withheld for tax purposes as Treasury shares |
|
| 1,066,667 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Issuance of shares for tax purposes as Treasury Shares |
|
| (421,611 | ) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 421,611 |
|
|
| (54,000 | ) |
|
| (54,000 | ) |
Issuance of 58,394 shares to employee & 9,619 shares were withheld for tax purposes as Treasury shares |
|
| 58,394 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Issuance of shares for tax purposes as Treasury Shares |
|
| (9,619 | ) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 9,619 |
|
|
| (1,000 | ) |
|
| (1,000 | ) |
Conversion of 890 preferred stocks to 9,030,870 common stock |
|
| 9,030,870 |
|
|
| 1,000 |
|
|
| - |
|
|
| - |
|
|
| 475,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 476,000 |
|
Excess of exercise price of 1,045 warrants over fair value |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 478,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 478,000 |
|
Net loss for the 3 months ended 9/30/2019 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| (1,550,000 | ) |
|
| - |
|
|
| - |
|
|
| (1,550,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2019 |
|
| 212,369,124 |
|
| $ | 22,000 |
|
|
| 909,090 |
|
| $ | - |
|
| $ | 91,726,000 |
|
| $ | (96,146,000 | ) |
|
| 659,448 |
|
| $ | (146,000 | ) |
| $ | (4,544,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options issued to officer as equity awards at $0.398 to $0.705 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 37,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 37,000 |
|
Shares issued to officer as equity awards at $0.398 to $0.705 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 71,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 71,000 |
|
Stock options issued to employee for services at $0.398 - $1.37 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 16,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 16,000 |
|
Shares issued to employee for services at $0.398 - $1.37 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 6,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 6,000 |
|
Stock options issued to consultant for services at $0.43 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 6,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 6,000 |
|
Shares issued to consultant for services at $0.43 - $0.73 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 2,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 2,000 |
|
Conversion of 291 preferred stocks to 6,182,539 common stock |
|
| 6,182,539 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 156,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 156,000 |
|
Excess of exercise price of 147 warrants over fair value |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 46,000 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 46,000 |
|
Warrants Modification expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 1,212,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 1,212,000 |
|
Net loss for the 3 months ended 12/31/2019 |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| (2,625,000 | ) |
|
| - |
|
|
| - |
|
|
| (2,625,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2019 |
|
| 218,551,663 |
|
| $ | 22,000 |
|
|
| 909,090 |
|
| $ | - |
|
| $ | 93,278,000 |
|
| $ | (98,771,000 | ) |
|
| 659,448 |
|
| $ | (146,000 | ) |
| $ | (5,617,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements. |
7 |
Table of Contents |
INNOVATION PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE SIX MONTHS ENDED DECEMBER 31, 2019 AND 2018
(Unaudited)
(Rounded to nearest thousand)
|
| 2019 |
|
| 2018 |
| ||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
| ||
Net loss |
| $ | (4,175,000 | ) |
| $ | (6,029,000 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Common stock and stock options issued as compensation |
|
| 374,000 |
|
|
| 516,000 |
|
Amortization of patent costs |
|
| 186,000 |
|
|
| 185,000 |
|
Patent write off |
|
| - |
|
|
| 155,000 |
|
Depreciation of equipment |
|
| 1,000 |
|
|
| 1,000 |
|
(Gain) loss on disposal of equipment |
|
| - |
|
|
| (40,000 | ) |
Interest expense-preferred stock |
|
| 40,000 |
|
|
| 1,975,000 |
|
Change in fair value of preferred stock |
|
| (102,000 | ) |
|
| - |
|
Warrants modification expense |
|
| 1,212,000 |
|
|
| - |
|
Impairment expense of operating lease |
|
| 643,000 |
|
|
| - |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and security deposits |
|
| 17,000 |
|
|
| (6,000 | ) |
Accounts payable |
|
| 158,000 |
|
|
| (738,000 | ) |
Accrued expenses |
|
| 35,000 |
|
|
| 64,000 |
|
Accrued officers’ salaries and payroll taxes |
|
| 195,000 |
|
|
| (56,000 | ) |
Operating lease liability |
|
| (28,000 | ) |
|
| - |
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
| (1,444,000 | ) |
|
| (3,973,000 | ) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Sales proceeds of property, plant and equipment |
|
| - |
|
|
| 40,000 |
|
Patent costs |
|
| (45,000 | ) |
|
| (36,000 | ) |
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
| (45,000 | ) |
|
| 4,000 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from exercise of warrants |
|
| 1,152,000 |
|
|
| - |
|
Purchase of treasury stock |
|
| (55,000 | ) |
|
| (91,000 | ) |
Proceeds from issuance of preferred stocks and warrants, net of financing costs |
|
| - |
|
|
| 2,384,000 |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
| 1,097,000 |
|
|
| 2,293,000 |
|
|
|
|
|
|
|
|
|
|
NET DECREASE IN CASH |
|
| (392,000 | ) |
|
| (1,676,000 | ) |
|
|
|
|
|
|
|
|
|
CASH, BEGINNING OF PERIOD |
|
| 579,000 |
|
|
| 2,424,000 |
|
|
|
|
|
|
|
|
|
|
CASH, END OF PERIOD |
| $ | 187,000 |
|
| $ | 748,000 |
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION |
|
|
|
|
|
|
|
|
Cash paid for interest |
| $ | 66,000 |
|
| $ | 114,000 |
|
Cash paid for tax |
| $ | - |
|
| $ | - |
|
SUPPLEMENTAL DISCLOSURE OF NON-CASH FLOW INVESTING AND FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Conversion of Series B Convertible Preferred stock to Common stock |
| $ | 632,000 |
|
| $ | - |
|
Excess of exercise price of 1,192 warrants over fair value |
| $ | 524,000 |
|
| $ | - |
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements. |
8 |
Table of Contents |
INNOVATION PHARMACEUTICALS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2019
(Unaudited)
Note 1. Basis of Presentation and Nature of Operations
Unaudited Interim Financial Information
The accompanying unaudited condensed consolidated financial statements of Innovation Pharmaceuticals Inc. have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission, or the SEC, including the instructions to Form 10-Q and Regulation S-X. Certain information and note disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) have been condensed or omitted from these statements pursuant to such rules and regulations and, accordingly, they do not include all the information and notes necessary for comprehensive consolidated financial statements and should be read in conjunction with our audited financial statements for the year ended June 30, 2019, included in our Annual Report on Form 10-K for the year ended June 30, 2019.
In the opinion of the management of Innovation Pharmaceuticals Inc., all adjustments, which are of a normal recurring nature, necessary for a fair statement of the results for the three-month and six-month periods have been made. Results for the interim period presented are not necessarily indicative of the results that might be expected for the entire fiscal year. When used in these notes, the terms “Company,” “we,” “us” or “our” mean Innovation Pharmaceuticals Inc.
Basis of Presentation
Innovation Pharmaceuticals Inc. (“Innovation”) was incorporated on August 1, 2005 in the State of Nevada. Effective June 5, 2017, the Company amended its Articles of Incorporation and changed its name from Cellceutix Corporation to Innovation Pharmaceuticals Inc. On February 15, 2019, the Company formed IPIX Pharma Limited (“IPIX Pharma”), a wholly-owned subsidiary incorporated under the Companies Act 2014 of Ireland. IPIX Pharma is a Private Company Limited by Shares. The subsidiary will serve as a key hub for strategic collaboration with European companies and medical communities in addition to providing cost-saving efficiencies and flexibility with respect to developing Brilacidin under European Medicines Agency standards.
The Company is a clinical stage biopharmaceutical company. The Company’s common stock is quoted on OTCQB, symbol “IPIX.”
Basis of Consolidation
These consolidated financial statements include the accounts of Innovation, a Nevada corporation, and our wholly-owned subsidiary, IPIX Pharma, an Ireland limited company. All significant intercompany transactions and balances have been eliminated in consolidation. Translation gains and losses for the six months ended December 31, 2019 and 2018 were not significant.
9 |
Table of Contents |
Nature of Operations - Overview
We are in the business of developing innovative small molecule therapies to treat diseases with significant medical need, particularly in the areas of inflammatory diseases, cancer, dermatology and anti-infectives. Our strategy is to use our business and scientific expertise to maximize the value of our pipeline. We will do this by focusing initially on our lead compounds, Brilacidin and Kevetrin, and advancing them as quickly as possible along the regulatory pathway. We aim to develop the highest quality data and broadest intellectual property to support our compounds. We discontinued our Prurisol psoriasis program in late 2018.
We currently own all development and marketing rights to our products, other than the rights granted to Alfasigma S.p.A. in July 2019 for the development, manufacturing and commercialization of locally-administered Brilacidin for UP/UPS. In order to successfully develop and market our products, we may have to partner with additional companies. Prospective partners may require that we grant them significant development and/or commercialization rights in return for agreeing to share the risk of development and/or commercialization.
Note 2. Going Concern and Liquidity
These condensed consolidated financial statements have been prepared on the assumption that the Company is a going concern, which contemplates the realization of its assets and the settlement of its liabilities in the normal course of operations.
We have incurred recurring losses since inception and expect to continue to incur losses as a result of costs and expenses related to our research and development of our compounds and our corporate general and administrative expenses. As of December 31, 2019, the Company has an accumulated deficit of approximately $98.8 million, representative of recurring losses since inception. The Company earned $0.4 million as an initial upfront payment under the terms of the License Agreement with Alfasigma (see Note 7. Exclusive License Agreement to the condensed consolidated financial statements). The Company does not currently have any products on the market and will continue to not have significant revenues until it begins to market its products after it has obtained the necessary Federal Drug Administration (the “FDA”) and/ or other health authorities approval, or generates income from the licensing of its drugs. As a result, the Company expects to continue to incur losses over the next 12 months from the date of this filing. Accordingly, the Company’s planned operations, including total budgeted expenditures of approximately $11.5 million for the next twelve months, raise substantial doubt about its ability to continue as a going concern.
As of December 31, 2019, the Company’s cash amounted to $0.2 million and current liabilities amounted to $7.8 million. The Company had expended substantial funds on its clinical trials and expects to continue our spending on research and development expenditures. The Company’s net cash used in operating activities for the six months ended December 31, 2019 was approximately $1.4 million, and current projections indicate that the Company will continue to have negative cash flows from operating activities for the foreseeable future. Our net losses incurred for the six months ended December 31, 2019 and 2018, amounted to $4.2 million and $6.0 million, respectively, and we had a working capital deficit of approximately $7.6 million and $6.7 million, respectively at December 31, 2019 and June 30, 2019.
The Company’s primary sources of liquidity are cash and cash equivalents as well as issuances of its equity securities. During the six months ended December 31, 2019, the Company issued 1,192 shares of its Series B 5% convertible preferred stock, for aggregate gross proceeds of $1.2 million, upon exercise of 1,192 warrants. As of December 31, 2019, Series 1-4 warrants to purchase 6,528 shares of Series B preferred stock were outstanding. As the Company cannot be certain the remaining warrants will be exercised, there can be no assurance those funds or other funds will be available when needed (see Note 13. Equity Transactions to the condensed consolidated financial statements).
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The amount of cash and cash equivalents at December 31, 2019 is approximately $0.2 million. The Company expects to seek to obtain additional funding through business development activities (i.e. licensing and partnerships) and future equity issuances. There can be no assurance as to the availability or terms upon which such financing and capital might be available. The Company will be unable to proceed with its planned drug development programs, meet its administrative expense requirements, capital costs, or staffing costs without raising additional capital in the future. These condensed consolidated financial statements do not include any adjustments related to the carrying values and classifications of assets and liabilities that would be necessary should the Company be unable to continue as a going concern.
3. Significant Accounting Policies and Recent Accounting Pronouncements
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant items subject to such estimates and assumptions include contract research accruals, recoverability of long-lived assets, valuation of equity grants and income tax valuation. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.
Basic Loss per Share
Basic and diluted loss per share is computed based on the weighted average common shares and common share equivalents outstanding during the period. Common share equivalents consist of stock options, convertible notes payable underlying shares, unvested restricted stock and Series B Convertible Preferred Stock at a conversion price at approximately $0.04 and $0.09 per share for the six months ended December 31, 2019 and 2018, respectively. Common share equivalents of 72.4 million shares and 70.1 million shares of common stock were excluded from the computation of diluted loss per share for the six months ended December 31, 2019 and 2018, respectively, because we incurred net losses for the six months ended December 31, 2019 and 2018, and the effect of including these potential common shares in the net loss per share calculations would be antidilutive and are therefore not included in the calculations.
Treasury Stock
The Company accounts for treasury stock using the cost method. There were 659,448 shares and 228,218 shares of treasury stock outstanding, purchased at a total cumulative cost of $146,000 and $91,000 as of December 31, 2019 and June 30, 2019, respectively (see Note 12. Equity Incentive Plans, Stock-Based Compensation, Exercise of Options and Warrants Outstanding to the condensed consolidated financial statements).
Treasury stock, representing shares of the Company’s common stock that have been acquired for payroll tax withholding on vested stock grants, is recorded at its acquisition cost and these shares are not considered outstanding.
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Revenue Recognition
On July 1, 2019, the Company adopted the new accounting standard ASC 606 (Topic 606), Revenue from Contracts with Customers, and all the related amendments (“new revenue standard”) using the modified retrospective method applied to those contracts which were not completed as of July 1, 2019. The adoption of ASC Topic 606 did not have impact on the Company’s consolidated financial statements or cash flows, for the Company had no revenue and no contracts which were not completed as of July 1, 2019.
The Company has acquired and further developed license rights to Functional Intellectual Property (“functional IP”) that it licenses to customers for defined license periods. A functional IP license is a license to intellectual property that has significant standalone functionality that does not include supporting or maintaining the intellectual property during the license period. The Company’s patented drug formulas have significant standalone functionality in the form of their abilities to treat a disease or condition. Further, there is no expectation that the Company will undertake any activities to change the functionality of the drug formulas during the license periods (see Note 7. Exclusive License Agreement to the condensed consolidated financial statements).
Under the terms of the License Agreement, Alfasigma made an initial non-refundable payment of $0.4 million to the Company and will make additional payments of up to $24.0 million to the Company based upon the achievement of certain milestones, including a $1.0 million payment due following commencement of the first phase III clinical trial of Brilacidin for UP/UPS and an additional $1.0 million payment upon the filing of a marketing approval application with the U.S. Food and Drug Administration or the European Medicines Agency. In addition, Alfasigma will pay a royalty to the Company equal to six percent of net sales of Brilacidin for UP/UPS, subject to adjustment as provided in the License Agreement.
Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services.
Pursuant to ASC 606, a customer is a party that has contracted with an entity to obtain goods or services that are an output of the entity’s ordinary activities in exchange for consideration.
To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps:
(i) identify the contract(s) with a customer;
(ii) identify the performance obligations in the contract, including whether they are distinct in the context of the contract;
(iii) determine the transaction price, including the constraint on variable consideration;
(iv) allocate the transaction price to the performance obligations in the contract; and
(v) recognize revenue when (or as) the Company satisfies each performance obligation.
The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. If a promised good or service is not distinct, it is combined with other performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
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The terms of the Company’s licensing agreement include the following:
(i) up-front fees;
(ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and
(iii) royalties on net sales of licensed products.
License of Intellectual Property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. If not distinct, the license is combined with other performance obligations in the contract. For licenses that are combined with other performance obligations, the Company assesses the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone Payments: At the inception of each arrangement that includes developmental and regulatory milestone payments, the Company evaluates whether the achievement of each milestone specifically relates to the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service within a performance obligation. If the achievement of a milestone is considered a direct result of the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service and the receipt of the payment is based upon the achievement of the milestone, the associated milestone value is allocated to that distinct good or service. If the milestone payment is not specifically related to the Company’s effort to satisfy a performance obligation or transfer a distinct good or service, the amount is allocated to all performance obligations using the relative standalone selling price method. The Company also evaluates the milestone to determine whether they are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price to be allocated, otherwise, such amounts are constrained and excluded from the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the transaction price. Any such adjustments to the transaction price are allocated to the performance obligations on the same basis as at contract inception. Amounts allocated to a satisfied performance obligation shall be recognized as revenue, or as a reduction of revenue, in the period in which the transaction price changes.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied) in accordance with the royalty recognition constraint.
Accounting for Stock Based Compensation
The stock-based compensation expense incurred by the Company for employees and directors in connection with its stock option plan is based on the employee model of ASC 718, and the fair market value of the options is measured at the grant date. Under ASC 718 employee is defined as “An individual over whom the grantor of a share-based compensation award exercises or has the right to exercise sufficient control to establish an employer-employee relationship based on common law as illustrated in case law and currently under U.S. “tax regulations.” Our consultants do not meet the employer-employee relationship as defined by the IRS and therefore are accounted for under ASC 505-50. Effective July 1, 2019, the Company adopted ASU 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting.
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The Company followed the accounting guidance in ASC 505-50-30-11 until July 1, 2019 which provides that an issuer shall measure the fair value of the equity instruments in these transactions using the stock price and other measurement assumptions as of the earlier of the following dates, referred to as the measurement date:
| i. | The date at which a commitment for performance by the counterparty to earn the equity instruments is reached (a performance commitment); and |
| ii. | The date at which the counterparty’s performance is complete. |
Upon the adoption of ASU 2018-07, the Company measured the fair value of equity instruments for nonemployee based payment awards on the grant date.
The components of stock-based compensation expense included in the Company’s Condensed Statement of Operations for the three months and six months ended December 31, 2019 and 2018 are as follows (rounded to nearest thousand):
|
| Three months ended December 31 |
|
| Six months ended December 31 |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| 2019 |
|
| 2018 |
| ||||
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Professional fees |
| $ | 7,000 |
|
| $ | 12,000 |
|
| $ | 16,000 |
|
| $ | 25,000 |
|
Employees’ bonus |
|
| 22,000 |
|
|
| 49,000 |
|
|
| 60,000 |
|
|
| 93,000 |
|
Officers’ bonus |
|
| 109,000 |
|
|
| 226,000 |
|
|
| 298,000 |
|
|
| 398,000 |
|
Total stock-based compensation expense |
| $ | 138,000 |
|
| $ | 287,000 |
|
| $ | 374,000 |
|
| $ | 516,000 |
|
Recent Adopted Accounting Pronouncements
In June 2018, the FASB issued ASU 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which allows companies to account for nonemployee awards in the same manner as employee awards. The guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those annual periods. This new pronouncement has been adopted in the first quarter of fiscal 2020 and did not have a material effect on the Company’s financial position, results of operations or cash flows.
Prior to July 1, 2019, the Company accounted for leases under ASC 840, Accounting for Leases. Effective July 1, 2019, the Company adopted the guidance of ASC 842, Leases, which requires an entity to recognize a right-of-use asset and a lease liability for virtually all leases. The Company adopted ASC 842 using a modified retrospective approach. The new standard provides a number of optional practical expedients in transition. The Company elected the ‘package of practical expedients,’ which permitted the Company not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs; and all of the new standard’s available transition practical expedients. As a result, the comparative financial information has not been updated and the required disclosures prior to the date of adoption have not been updated and continue to be reported under the accounting standards in effect for those periods. The adoption of ASC 842 on July 1, 2019 resulted in the recognition of operating lease right-of-use assets of approximately $670,000, lease liabilities for operating leases of approximately $670,000, and a zero cumulative-effect adjustment to accumulated deficit. The Company elected to exclude from its balance sheets recognition of leases having a term of 12 months or less (“short-term leases”). Lease expense is recognized on a straight-line basis over the lease term. The Company determined that the operating lease right-of-use asset is impaired as of September 30, 2019, and it recognized an impairment loss of approximately $643,000, after recording amortization of the right-of-use asset for July, August, and September 2019 totaling approximately $27,000, resulting in a carrying value of $0 since September 30, 2019 (see Note 8. Operating Lease to the condensed consolidated financial statements).
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In July 2017, the FASB issued Accounting Standards Update (“ASU”) 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480) and Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features; and II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception. Part I of this update addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option. Part II of this update addresses the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification. This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable non-controlling interests. The amendments in Part II of this update do not have an accounting effect. This ASU is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018, with early adoption permitted. The adoption of ASU 2017-11, during the year ended June 30, 2019, did not have any impact on the financial statements and related disclosures.
4. Patents, net
Patents, net consisted of the following (rounded to nearest thousand):
|
| Useful life |
|
| December 31, 2019 |
|
| June 30, 2019 |
| |||
|
|
|
|
|
|
|
|
|
| |||
Purchased Patent Rights- Brilacidin, and related compounds |
|
| 14 |
|
| $ | 4,082,000 |
|
| $ | 4,082,000 |
|
Purchased Patent Rights-Anti-microbial- surfactants and related compounds |
|
| 12 |
|
|
| 144,000 |
|
|
| 144,000 |
|
Patents - Kevetrin and related compounds |
|
| 17 |
|
|
| 1,163,000 |
|
|
| 1,118,000 |
|
|
|
|
|
|
|
| 5,389,000 |
|
|
| 5,344,000 |
|
Less: Accumulated amortization for Brilacidin, Anti-microbial- surfactants and related compounds |
|
|
|
|
|
| (1,917,000 | ) |
|
| (1,765,000 | ) |
Accumulated amortization for Patents-Kevetrin and related compounds |
|
|
|
|
|
| (271,000 | ) |
|
| (237,000 | ) |
Total |
|
|
|
|
| $ | 3,201,000 |
|
| $ | 3,342,000 |
|
The patents are amortized on a straight-line basis over the useful lives of the assets, determined to be 12-17 years from the date of acquisition.
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Amortization expense for the three months ended December 31, 2019 and 2018 was approximately $93,000 and $92,000, respectively and was approximately $186,000, and $185,000 for the six months ended December 31, 2019 and 2018, respectively.
During the six months ended December 31, 2019 and 2018, the Company has written off the Prurisol patent and other patents of approximately $0 and $155,000, respectively and included in general and administrative expenses.
At December 31, 2019, the future amortization period for all patents was approximately 5.68 years to 16.75 years. Future estimated annual amortization expenses are approximately $186,000 for the year ending June 30, 2020, $372,000 for each year from 2021 to 2024, and total of $1,527,000 for the year ending June 30, 2025 and thereafter.
5. Accrued Expenses – Related Parties and Other
Accrued expenses consisted of the following (rounded to nearest thousand):
|
| December 31, 2019 |
|
| June 30, 2019 |
| ||
|
|
|
|
|
|
| ||
Accrued research and development consulting fees |
| $ | 45,000 |
|
| $ | 40,000 |
|
Accrued rent (Note 10) - related parties |
|
| 8,000 |
|
|
| 8,000 |
|
Accrued interest (Note 11) - related parties |
|
| 67,000 |
|
|
| 37,000 |
|
|
|
|
|
|
|
|
|
|
Total |
| $ | 120,000 |
|
| $ | 85,000 |
|
6. Accrued Salaries and Payroll Taxes - Related Parties and Other
Accrued salaries and payroll taxes consisted of the following (rounded to nearest thousand):
|
| December 31, 2019 |
|
| June 30, 2019 |
| ||
|
|
|
|
|
|
| ||
Accrued salaries - related parties |
| $ | 2,725,000 |
|
| $ | 2,999,000 |
|
Accrued salaries – ex- President and Chief Medical Officer |
|
| 425,000 |
|
|
| - |
|
Accrued payroll taxes - related parties |
|
| 132,000 |
|
|
| 130,000 |
|
Accrued salaries |
|
| 29,000 |
|
|
| - |
|
Withholding tax – payroll & other taxes |
|
| 47,000 |
|
|
| 33,000 |
|
|
|
|
|
|
|
|
|
|
Total |
| $ | 3,358,000 |
|
| $ | 3,162,000 |
|
The Company has accrued payroll to Dr. Krishna Menon, ex-President of Research of approximately $1,443,000 for his past services with the Company, and this amount was included in Accrued salaries – related parties. Dr. Krishna Menon’s employment was terminated with the Company on September 18, 2018, and Dr. Krishna Menon resigned from the Company’s Board of Directors on December 11, 2018. Dr. Menon, on behalf of himself and Kard Scientific, a company controlled by the Menon family, Dr. Krishna Menon, Anita Menon, Rajah Menon, and Doret Menon, demanded payment of these amounts in October 2019; however, the Company disputes the underlying basis for these amounts and notified Dr. Menon in November 2019 of the Company’s intent not to pay them.
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7. Exclusive License Agreement
On July 18, 2019, the Company entered into an Exclusive License Agreement (the “License Agreement”) with Alfasigma S.p.A., a global pharmaceutical company (“Alfasigma”), granting Alfasigma the worldwide right to develop, manufacture and commercialize locally-administered Brilacidin for the treatment of ulcerative proctitis/ulcerative proctosigmoiditis (UP/UPS).
Under the terms of the License Agreement, Alfasigma made an initial upfront non-refundable payment of $0.4 million to the Company and will make additional payments of up to $24.0 million to the Company based upon the achievement of certain milestones, including a $1.0 million payment due following commencement of the first phase III clinical trial of Brilacidin for UP/UPS and an additional $1.0 million payment upon the filing of a marketing approval application with the U.S. Food and Drug Administration or the European Medicines Agency. In addition to the milestones, Alfasigma will pay a royalty to the Company equal to six percent of net sales of Brilacidin for UP/UPS, subject to adjustment as provided in the License Agreement.
8. Operating Leases
Operating lease right-of-use (“ROU”) assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Generally, the implicit rate of interest in arrangements is not readily determinable and the Company utilizes its incremental borrowing rate in determining the present value of lease payments. The Company’s incremental borrowing rate is a hypothetical rate based on its understanding of what its credit rating would be. The operating lease ROU asset includes any lease payments made and excludes lease incentives. Our variable lease payments primarily consist of maintenance and other operating expenses from our real estate leases. Variable lease payments are excluded from the ROU assets and lease liabilities and are recognized in the period in which the obligation for those payments is incurred. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
We have lease agreements with lease and non-lease components. We have elected to account for these lease and non-lease components as a single lease component. We are also electing not to apply the recognition requirements to short-term leases of twelve months or less and instead will recognize lease payments as expense on a straight-line basis over the lease term.
The Company determined that the operating lease right-of-use asset is fully impaired on September 30, 2019 because of the Company’s current lack of working capital (see Note 2. Going Concern and Liquidity to the condensed consolidated financial statements) resulting in its limited usage of the leased office. The Company has been unable to enter into a sub-lease agreement for this leased office on September 30, 2019. As such, the Company recognized an impairment loss of approximately $643,000, after recording amortization of the right-of-use asset for July, August, and September 2019 totaling approximately $27,000, resulting in a carrying value of $0 since September 30, 2019. The Company vacated the leased office space as of December 31, 2019, and in January 2020 the Company initiated a lawsuit against the leasor relating to an automatic extension of the lease for the office space and related matters (see Note 15. Subsequent Events to the condensed consolidated financial statements).
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The components of lease expense and supplemental cash flow information related to leases for the period are as follows:
|
| Six Months Ended December 31, 2019 |
| |
Lease Cost |
|
|
| |
Operating lease cost (included in general and administrative in the Company’s condensed consolidated statement of operations) |
| $ | 84,000 |
|
Variable lease cost |
|
| 4,000 |
|
|
| $ | 88,000 |
|
|
|
|
|
|
Other Information |
|
|
|
|
Cash paid for amounts included in the measurement of lease liabilities for the six months ended December 31, 2019 |
| $ | 112,000 |
|
Weighted average remaining lease term – operating leases (in years) |
| 3.67 years |
| |
Average discount rate – operating leases |
|
| 18.00 | % |
The supplemental balance sheet information related to leases for the period is as follows:
|
| At December 31, 2019 |
| |
Operating leases |
|
|
| |
Short-term operating lease liabilities |
| $ | 126,000 |
|
Long-term operating lease liabilities |
|
| 489,000 |
|
Total operating lease liabilities |
| $ | 615,000 |
|
The following table provides maturities of the Company’s lease liabilities at December 31, 2019 as follows:
Fiscal Year Ending June 30, |
| Operating Leases |
| |
2020 (remaining 9 months) |
| $ | 112,000 |
|
2021 |
|
| 223,000 |
|
2022 |
|
| 223,000 |
|
2023 |
|
| 223,000 |
|
2024 (remaining 3 months) |
|
| 60,000 |
|
Total lease payments |
|
| 841,000 |
|
Less: Imputed interest/present value discount |
|
| (226,000 | ) |
Present value of lease liabilities |
| $ | 615,000 |
|
Operating lease cost for the three months and the six months ended December 31, 2019 was approximately $28,000 and $84,000, respectively. Rent expense, net of lease income, under this operating lease agreement was approximately $54,000 and $107,000 for the three months and the six months ended December 31, 2018, respectively.
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9. Commitments and Contingencies
Contractual Commitments
The Company has total non-cancelable contractual minimum commitments of approximately $2 million to contract research organizations as of December 31, 2019. Expenses are recognized when services are performed by the contract research organizations.
Contingent Liability - Disputed Invoices
As described in Note 8, the Company has accrued payroll to Dr. Krishna Menon, ex-President of Research of approximately $1,443,000 for his past services with the Company, and this amount was included in accrued salaries and payroll taxes. As described in Note 10, the Company has a payable to KARD of approximately $1,486,000 for its research and development expenses and this amount was included in accounts payable. KARD is a company owned by Dr. Krishna Menon. Dr. Krishna Menon’s employment was terminated with the Company on September 18, 2018, and Dr. Krishna Menon resigned from the Company’s Board of Directors on December 11, 2018. Dr. Menon, on behalf of himself and KARD, demanded payment of these amounts in October 2019; however, the Company disputes the underlying basis for these amounts and notified Dr. Menon in November 2019 of the Company’s intent not to pay them.
All of the above disputed invoices were reflected as current liabilities as of December 31, 2019.
10. Related Party Transactions
Office Lease
The Company charged Kard Scientific (“KARD”) $1,800 for space for the two months of July and August, 2018. Dr. Menon, a significant shareholder of the Company and the former President of Research and former director of the Company, also serves as the Chief Operating Officer and Director of Kard Scientific. Dr. Menon’s employment was terminated with the Company on September 18, 2018, and Dr. Menon resigned from the Company’s Board of Directors on December 11, 2018. As of September 1, 2018, KARD no longer leases space from the Company.
Pre-clinical Studies
The Company previously engaged KARD to conduct specified pre-clinical studies. The Company did not have an exclusive arrangement with KARD. All work performed by KARD needed prior approval by the executive officers of the Company, and the Company retained all intellectual property resulting from the services by KARD. The Company no longer uses KARD. At December 31, 2019 and June 30, 2019, the accrued research and development expenses payable to KARD was approximately $1,486,000 and this amount was included in accounts payable. Dr. Menon, on behalf of himself and KARD, demanded payment of these amounts in October 2019; however, the Company disputes the underlying basis for these amounts and notified Dr. Menon in November 2019 of the Company’s intent not to pay them.
Other related party transactions are disclosed in Note 11 below.
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11. Convertible Note Payable - Related Party
The Ehrlich Promissory Note C is an unsecured demand note with Mr. Ehrlich, the Company’s Chairman and CEO, that originated in 2010, bears 9% simple interest per annum and is convertible into the Company’s Class A common stock at $0.50 per share.
On May 8, 2012, the Company did not have the ability to repay the Ehrlich Promissory Note C loan of approximately $2,022,000 and agreed to change the interest rate from 9% simple interest to 10% simple interest, and the Company issued 2,000,000 Equity Incentive Options exercisable at $0.51 per share equal to 110% of the closing bid price of $0.46 per share on May 7, 2012. Options are valid for ten years from the date of issuance.
On January 29, 2019, the Company issued 909,090 shares of Class B common stock at the option exercise price of $0.11 per share to Mr. Ehrlich, the Company’s Chairman and CEO, for his partial exercise of his option, paid by the cancellation of debt to Mr. Ehrlich of $100,000 to satisfy the exercise price (as permitted pursuant to the terms of the option agreement).
As of December 31, 2019 and June 30, 2019, the principal balance of this convertible note payable to Mr. Ehrlich, the Company’s Chairman and CEO was approximately $1,922,000 after the above mentioned cancellation of debt of $100,000 to satisfy the exercise price of his option on January 29, 2019.
During the six months ended December 31, 2019 and 2018, the Company accrued interest of $96,000 and $101,000 to Mr. Ehrlich, respectively and paid the interests in cash of $66,000 and $114,000 to Mr. Ehrlich, respectively. As of December 31, 2019 and June 30, 2019, the balance of accrued interest payable were $67,000 and $36,000, respectively (see Note 5. Accrued Expenses – Related Parties and Other to the condensed consolidated financial statements).
As of December 31, 2019 and June 30, 2019, the total outstanding balances of principal and interest were approximately $1,989,000 and $1,959,000, respectively.
12. Equity Incentive Plans, Stock-Based Compensation, Exercise of Options and Warrants Outstanding
2016 Equity Incentive Plan
On June 30, 2016, the Board of Directors adopted the Company’s 2016 Equity Incentive Plan (the “2016 Plan”). The 2016 Plan became effective upon adoption by the Board of Directors on June 30, 2016.
Up to 20,000,000 shares of the Company’s Class A common stock may be issued under the 2016 Plan (subject to adjustment as described in the 2016 Plan); provided that (1) no Outside Director (as defined in the 2016 Plan) may be granted awards covering more than 250,000 shares of common stock in any year and (2) no participant shall be granted, during any one year period, options to purchase common stock and stock appreciation rights with respect to more than 4,000,000 shares of common stock in the aggregate or any other awards with respect to more than 2,500,000 shares of common stock in the aggregate. The 2016 Plan permits the grant of ISOs, non-qualified stock options, stock appreciation rights, restricted awards, performance share awards and performance compensation awards to employees, directors, and consultants of the Company and its affiliates.
In connection with adoption of the 2016 Plan, the Board of Directors also approved forms of Incentive Stock Option Agreement for Employees, Non-qualified Stock Option Agreement for Employees, Non-qualified Stock Option Agreement for Non-Employee Directors, Restricted Stock Award Agreement for Employees and Restricted Stock Award Agreement for Non-Employee Directors that will be utilized by the Company to grant options and restricted shares under the 2016 Plan.
On January 29, 2019, the Company issued 909,090 shares of Class B common stock at the option exercise price of $0.11 per share to Mr. Ehrlich, the Company’s Chairman and CEO (see Note 11. Convertible Note Payable - Related Party to the condensed consolidated financial statements).
20 |
Table of Contents |
Stock Options Issued and Outstanding
The following table summarizes all stock option activity under the Company’s equity incentive plans:
|
| Number of |
|
| Weighted Average |
|
| Weighted Average |
|
| Aggregate Intrinsic Value |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Outstanding at June 30, 2018 |
|
| 41,643,571 |
|
| $ | 0.22 |
|
|
| 2.76 |
|
| $ | 17,523,113 |
|
Granted |
|
| 1,195,826 |
|
| $ | 0.31 |
|
|
| 7.64 |
|
|
|
|
|
Exercised |
|
| (909,090 | ) |
| $ | 0.11 |
|
|
|
|
|
|
|
|
|
Forfeited/expired |
|
| (19,260,424 | ) |
| $ | 0.21 |
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2019 |
|
| 22,669,883 |
|
| $ | 0.24 |
|
|
| 2.41 |
|
| $ | 1,340,000 |
|
Granted |
|
| 790,826 |
|
| $ | 0.13 |
|
|
| 10.0 |
|
|
|
|
|
Exercised |
|
| - |
|
| $ | - |
|
|
| - |
|
|
|
|
|
Forfeited/expired |
|
| (387,165 | ) |
| $ | 0.70 |
|
|
| - |
|
|
|
|
|
Outstanding at December 31, 2019 |
|
| 23,073,544 |
|
| $ | 0.23 |
|
|
| 2.17 |
|
| $ | - |
|
Exercisable at December 31, 2019 |
|
| 21,667,478 |
|
| $ | 0.23 |
|
|
| 1.74 |
|
| $ | - |
|
Unvested stock options at December 31, 2019 |
|
| 1,406,066 |
|
| $ | 0.23 |
|
|
| 8.76 |
|
| $ | - |
|
Stock-Based Compensation
The Company recognized approximately $374,000 and $516,000 of total stock-based compensation costs related to equity grant awards for the six months ended December 31, 2019 and 2018, respectively.
The $374,000 of stock-based compensation expense for the six months ended December 31, 2019 included approximately $158,000 of stock options expense and $216,000 of restricted stock awards.
During the six months ended December 31, 2019 and 2018
On September 1, 2019, the Company issued to Dr. Arthur Bertolino, the President and Chief Medical Officer of the Company,for his services rendered 1,066,667 shares of common stock, vesting 50% upon the first anniversary of the grant date and 50% upon the second anniversary of the grant date, with acceleration in certain circumstances as provided in the award agreement. The Company also issued 617,839 stock options to purchase shares of the Company’s common stock. These stock options are valued at approximately $71,000, based on the closing bid price as quoted on the OTC on August 30, 2019 at $0.132 per share. These options were issued with an exercise price of $0.132 and vest 50% upon the first anniversary of the grant date and 50% upon the second anniversary of the grant date, with acceleration as defined in award agreement, with a ten year option term. During the six months ended December 31, 2019, the Company recorded approximately $35,000 of stock-based compensation expense in connection with the foregoing equity awards, including approximately $12,000 of stock option expense and $23,000 of stock awards. On December 19, 2019, Arthur P. Bertolino resigned as President and Chief Medical Officer and as a member of the Board of Directors of the Company, effective immediately.
21 |
Table of Contents |
On September 1, 2019, the Company also issued to Ms. Jane Harness, the Senior Vice President, Clinical Sciences and Portfolio Management of the Company, 58,394 shares of the Company’s common stock, 33 1/3% vesting upon the first anniversary of the grant date, 33 1/3% upon the second anniversary of the grant date and 33 1/3% upon the third anniversary of the grant date, with acceleration in certain circumstances as provided in the award agreement. The Company also issued 172,987 options to purchase common stock. These stock options are valued at approximately $20,000, based on the closing bid price as quoted on the OTC on August 30, 2019 at $0.132 per share. These options were issued with an exercise price of $0.132 and vest 33 1/3% upon the first anniversary of the grant date, 33 1/3% upon the second anniversary of the grant date, and 33 1/3% upon the third anniversary of the grant date, with acceleration of vesting upon certain events. During the six months ended December 31, 2019, the Company recorded approximately $3,000 of stock-based compensation expense in connection with the foregoing equity awards, including approximately $2,000 of stock option expense and $1,000 of stock awards.
On September 1, 2018, the Company issued to Dr. Arthur Bertolino, the President and Chief Medical Officer of the Company, for his services rendered 1,066,667 shares of common stock, vesting 50% upon the first anniversary of the grant date and 50% upon the second anniversary of the grant date, with acceleration in certain circumstances as provided in the award agreement. The Company also issued 617,839 stock options to purchase shares of the Company’s common stock. These stock options are valued at approximately $225,000, based on the closing bid price as quoted on the OTCQB on August 31, 2018 at $0.40 per share. These options were issued with an exercise price of $0.40 per share and vest 50% upon the first anniversary of the grant date and 50% upon the second anniversary of the grant date, with acceleration as defined in award agreement, with a ten year option term. During the six months ended December 31, 2019, the Company recorded approximately $164,000 of stock-based compensation expense in connection with the foregoing equity awards, including approximately $57,000 of stock option expense and $107,000 of stock awards. During the six months ended December 31, 2018, the Company recorded approximately $26,000 of stock-based compensation expense in connection with the foregoing equity awards, including approximately $9,000 of stock option expense and $17,000 of stock awards.
On September 1, 2018, the Company also issued to Ms. Jane Harness, the Senior Vice President, Clinical Sciences and Portfolio Management of the Company, 58,394 shares of the Company’s common stock, 33 1/3% vesting upon the first anniversary of the grant date, 33 1/3% upon the second anniversary of the grant date and 33 1/3% upon the third anniversary of the grant date, with acceleration in certain circumstances as provided in the award agreement. The Company also issued 172,987 options to purchase common stock. These stock options are valued at approximately $63,000, based on the closing bid price as quoted on the OTCQB on August 31, 2018 at $0.40 per share. These options were issued with an exercise price of $0.40 per share and vest 33 1/3% upon the first anniversary of the grant date, 33 1/3% upon the second anniversary of the grant date, and 33 1/3% upon the third anniversary of the grant date, with acceleration of vesting upon certain events. During the six months ended December 31, 2019, the Company recorded approximately $14,000 of stock-based compensation expense in connection with the foregoing equity awards including approximately $11,000 of stock option expense and $3,000 of stock awards. During the six months ended December 31, 2018, the Company recorded approximately $2,000 of stock-based compensation expense in connection with the foregoing equity awards including approximately $1,000 of stock option expense and $1,000 of stock awards.
22 |
Table of Contents |
On September 1, 2017, the Company agreed to grant to Dr. Arthur Bertolino, the President and Chief Medical Officer of the Company, under the 2016 Plan (i) 1,066,667 shares of restricted stock and (ii) a ten-year option to purchase 617,839 shares of the Company’s Class A common stock at an exercise price of $0.705 per share. Both shares and options shall vest upon the earliest to occur of the following: (1) 50% upon the first anniversary of the effective date and the remaining 50% upon the second anniversary of the effective date; (2) shares of the Company’s common stock close above $3.00 per share (as may be adjusted for any stock splits or similar actions); (3) the commencement of trading of shares of the Company’s common stock on a national securities exchange; or (4) upon a change in control of the Company. The 1,066,667 shares were valued at approximately $752,000 and the 617,839 stock options valued at approximately $399,000. Both shares and options were planned to be amortized over 2 years to September 1, 2019 unless the probability of the other above vesting requirements occurring were met at an earlier date. At June 30, 2018, the Company determined that it was not probable that these accelerated vesting provisions would occur earlier than the scheduled vesting date. During the six months ended December 31, 2019, the Company recorded approximately $99,000 of stock-based compensation expense in connection with the foregoing equity awards, including approximately $34,000 of stock option expense and $65,000 of stock awards. During the six months ended December 31, 2018, the Company recorded approximately $146,000 of stock-based compensation expense in connection with the foregoing equity awards, including approximately $51,000 of stock option expense and $95,000 of stock awards.
On September 1, 2017, the Company agreed to grant to Ms. Jane Harness, the Senior Vice President, Clinical Sciences and Portfolio Management of the Company under the 2016 Plan (i) 58,394 shares of restricted stock and (ii) a ten-year option to purchase 172,987 shares of the Company’s Class A common stock at an exercise price of $0.705 per share. Both shares and options shall vest upon the earliest to occur of the following: (1) one third upon the first anniversary of the effective date, one third upon the second anniversary of the effective date, and the remaining one third upon the third anniversary of the effective date; or (2) upon a change in control of the Company. The 58,394 shares were valued at approximately $41,000 and the 172,987 stock options valued at approximately $112,000. Both shares and options were planned to be amortized over 3 years to September 1, 2020 unless the other vesting requirements are met sooner. During the six months ended December 31, 2019, the Company recorded approximately $26,000 of stock-based compensation expense in connection with the foregoing equity awards including approximately $19,000 of stock option expense and $7,000 of stock awards. During the six months ended December 31, 2018, the Company recorded approximately $13,000 of stock-based compensation expense in connection with the foregoing equity awards including approximately $10,000 of stock option expense and $3,000 of stock awards.
On September 1, 2016, the Company and Jane Harness entered into an executive employment agreement as the Company’s VP, Clinical Sciences and Project Management, effective on September 1, 2016. Commencing on September 1, 2016, the Company agreed to pay Ms. Harness an annual salary of $250,000. In addition, the Company agreed to grant to Ms. Harness under the Company 2016 Equity Incentive Plan (i) 58,394 shares of restricted stock, which shall vest upon the earliest to occur of the following: (1) one third (33 1/3 %) upon the first anniversary of the effective date, one third (33 1/3 %) upon the second anniversary of the effective date, and the remaining one third (33 1/3 %) upon the third anniversary of the effective date; or (2) upon a Change in Control (as defined in the employment agreement) of the Company. Ten-year options to purchase 172,987 shares of the Company’s common stock were also granted at an exercise price of $1.37 per share, which shall vest upon the earliest to occur of the following: (1) one third (33 1/3 %) upon the first anniversary of the effective date, and the remaining balance vesting monthly in equal portions over the following 24 months; and (2) upon a Change in Control (as defined in the employment agreement) of the Company. The 58,394 shares were valued at approximately $80,000, which were amortized over three years to September 1, 2019. The 172,987 stock options were valued at approximately $220,000 and will be exercisable for 10 years at an exercise price of $1.26 per share. They were amortized over 3 years to September 1, 2019. During the six months ended December 31, 2019, the Company recorded approximately $17,000 of stock-based compensation expense in connection with the foregoing equity awards including approximately $12,000 of stock option expense and $5,000 of stock awards. During the six months ended December 31, 2018, the Company recorded approximately $25,000 of stock-based compensation expense in connection with the foregoing equity awards including approximately $18,000 of stock option expense and $7,000 of stock awards.
23 |
Table of Contents |
During the six months ended December 31, 2019, the Company recorded approximately $9,000 of stock-based compensation expense to consultants including approximately $6,000 of stock option expense and $3,000 of stock awards. During the six months ended December 31, 2018, the Company recorded approximately $13,000 of stock-based compensation expense to consultants including approximately $10,000 of stock option expense and $3,000 of stock awards.
Purchase of Treasury Stock
On September 1, 2019, 58,394 restricted shares issued to Ms. Harness vested. The total taxable compensation to Ms. Harness for the 58,394 vested shares was approximately $1,222, based upon the closing stock price on August 31, 2019 of $0.13 a share. The Company issued 48,775 common shares (net share issuance amount), to Ms. Harness. The remaining 9,619 shares of common stock were withheld from Ms. Harness for the payment of payroll taxes to the Federal and State taxing authorities and these shares withheld are being reported by the Company as treasury stock, at cost, on the Company’s accompanying balance sheets.
On September 1, 2019, 1,066,667 restricted shares issued to Dr. Bertolino vested. The total taxable compensation to Dr. Bertolino for the 1,066,667 vested shares was approximately $53,545, based upon the closing stock price on August 30, 2019 of $0.13 a share. The Company issued 645,056 common shares (net share issuance amount), to Dr. Bertolino. The remaining 421,611 shares of common stock were withheld from Dr. Bertolino for the payment of payroll taxes to the Federal and State taxing authorities and these shares withheld are being reported by the Company as treasury stock, at cost, on the Company’s accompanying balance sheets.
On September 1, 2018, 38,930 restricted shares issued to Ms. Harness vested. The total taxable compensation to Ms. Harness for the 38,930 vested shares was approximately $3,690, based upon the closing stock price on August 31, 2018 of $0.40 a share. The Company issued 29,658 common shares (net share issuance amount), to Ms. Harness. The remaining 9,272 shares of common stock were withheld from Ms. Harness for the payment of payroll taxes to the Federal and State taxing authorities and these shares withheld are being reported by the Company as treasury stock, at cost, on the Company’s accompanying balance sheets.
On September 1, 2018, 533,334 restricted shares issued to Dr. Bertolino vested. The total taxable compensation to Dr. Bertolino for the 533,334 vested shares was approximately $87,140, based upon the closing stock price on August 31, 2018 of $0.40 a share. The Company issued 314,387 common shares (net share issuance amount), to Dr. Bertolino. The remaining 218,946 shares of common stock were withheld from Dr. Bertolino for the payment of payroll taxes to the Federal and State taxing authorities and these shares withheld are being reported by the Company as treasury stock, at cost, on the Company’s accompanying balance sheets.
There were 659,448 shares and 228,218 shares held in treasury, purchased at a total cumulative cost of $146,000 and $91,000 as of December 31, 2019 and June 30, 2019, respectively.
24 |
Table of Contents |
Restricted Stock Awards Outstanding
The following summarizes our restricted stock activity:
|
|
|
|
| Weighted |
| ||
|
|
|
|
| Average |
| ||
|
| Number of |
|
| Grant Date |
| ||
|
| Shares |
|
| Fair Value |
| ||
Total awards outstanding at June 30, 2018 |
|
| 1,208,157 |
|
| $ | 0.72 |
|
Total shares granted |
|
| 1,130,061 |
|
| $ | 0.40 |
|
Total shares vested |
|
| (597,263 | ) |
| $ | 0.72 |
|
Total shares forfeited |
|
| (11,667 | ) |
| $ | 0.76 |
|
Total unvested shares outstanding at June 30, 2019 |
|
| 1,729,288 |
|
| $ | 0.51 |
|
|
|
|
|
|
|
|
|
|
Total shares granted |
|
| 1,125,061 |
|
| $ | 0.13 |
|
Total shares vested |
|
| (1,137,561 | ) |
| $ | 0.56 |
|
Total shares forfeited |
|
| - |
|
| $ | - |
|
Total unvested shares outstanding at December 31, 2019 |
|
| 1,716,788 |
|
| $ | 0.23 |
|
Scheduled vesting for outstanding restricted stock awards at December 31, 2019 is as follows:
|
| Year Ending December 31, |
| |||||||||||||||||
|
| 2020 |
|
| 2021 |
|
| 2022 |
|
| 2023 |
|
| Total |
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Scheduled vesting |
|
| - |
|
|
| 1,125,062 |
|
|
| 572,262 |
|
|
| 19,464 |
|
|
| 1,716,788 |
|
As of December 31, 2019, there was approximately $0.3 million of net unrecognized compensation cost related to unvested restricted stock-based compensation arrangements. This compensation is recognized on a straight-line basis resulting in approximately $0.2 million of compensation expected to be expensed over the next twelve months, and the total unrecognized stock-based compensation expense having a weighted average recognition period of 1.17 years.
Exercise of options
During the six months ended December 31, 2019 and 2018, there were no stock options exercised.
Stock Warrants Outstanding
Warrants to Purchase 5% convertible preferred stock (“Series B preferred stock”)
On October 5, 2018, the Company entered into a Securities Purchase Agreement (“Securities Purchase Agreement”) with one multi-family office for the sale of 2,000 shares of the Company’s newly-created Series B 5% convertible preferred stock (“Series B preferred stock”), for aggregate gross proceeds of approximately $2.0 million. Each share of preferred stock was initially sold together with three warrants: (i) a Series 1 warrant, which entitles the holder thereof to purchase 1.25 shares of preferred stock at $982.50 per share, or 2,500 shares of preferred stock in the aggregate for approximately $2.5 million in aggregate exercise price, for a period of up to nine months following issuance (later extended to 15 months following issuance), (ii) a Series 2 warrant, which entitles the holder thereof to purchase 1.25 shares of preferred stock at $982.50 per share, or 2,500 shares of preferred stock in the aggregate for approximately $2.5 million in aggregate exercise price, for a period of up to 15 months following issuance, and (iii) a Series 3 warrant, which entitles the holder thereof to purchase 1.50 shares of preferred stock at $982.50 per share, or 3,000 shares of preferred stock in the aggregate for approximately $2.9 million in aggregate exercise price, for a period of up to 24 months following issuance. On May 9, 2019, the Company entered into a warrant restructuring and additional issuance agreement (the “Issuance Agreement”) with the holders of the Series B preferred stock and warrants pursuant to which the Company issued an additional 100 shares of Series B preferred stock and Series 4 warrants to purchase an additional 2,500 shares of preferred stock, and the holders of the Series B preferred stock and warrants agreed to exercise warrants to purchase up to $2.0 million of Series B preferred stock through November 2019 subject to the conditions set forth in the Issuance Agreement. The Series 4 warrant entitles the holder thereof to purchase 2,500 shares of preferred stock at $982.50 per share for approximately $2.5 million in aggregate exercise price, for a period of up to nine months following issuance. In addition, the Company extended the termination date for the Series 1 warrants by six months, and agreed to issue one additional share of preferred stock to the Series B investors for each five shares issued upon the exercise of the existing warrants or Series 4 warrants through November 9, 2019, up to a maximum of 400 shares of preferred stock. On December 26, 2019, the Company extended the termination date for each series of warrants to December 31, 2021 (see Note 13. Equity Transactions to the condensed consolidated financial statements).
25 |
Table of Contents |
The warrants issued in connection with the Series B preferred stock are deemed to be free standing equity instruments and are recorded in permanent equity (additional paid in capital) based on a relative fair value allocation of proceeds (i.e. warrants’ relative fair value to the Series B preferred stock fair value (without the warrants)) with an offsetting discount to the Series B preferred stock.
Exercise of warrants
During the period from October 5, 2018 (date of issuance of preferred stock and warrants) to June 30, 2019, the Company issued 2,780 shares of its Series B 5% convertible preferred stock, for aggregate gross proceeds of $2.73 million, upon exercise of 2,780 warrants issued by the Company in October 2018. As of June 30, 2019, Series 1-4 warrants to purchase 7,720 shares of Series B preferred stock were outstanding.
During the six months ended December 31, 2019, the Company issued 1,192 shares of its Series B 5% convertible preferred stock, for aggregate gross proceeds of $1.2 million, upon exercise of 1,192 warrants. As of December 31, 2019, Series 1-4 warrants to purchase 6,528 shares of Series B preferred stock were outstanding. As the Company cannot be certain the remaining warrants will be exercised, there can be no assurance those funds or other funds will be available when needed (see Note 13. Equity Transactions to the condensed consolidated financial statements).
The following table summarizes the outstanding Series B preferred stock warrants: | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
| Warrants |
|
| Weighted Average Exercise Price |
|
| Weighted Average Remaining Contractual Life (Years) |
|
| Aggregate Intrinsic Value |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Outstanding at June 30, 2018 |
|
| - |
|
| $ | - |
|
|
| - |
|
| $ | - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
| 10,500 |
|
|
| 982.50 |
|
|
| 2.00 |
|
|
|
|
|
Exercised |
|
| (2,780 | ) |
|
| 982.50 |
|
|
| 2.00 |
|
|
|
|
|
Expired |
|
| - |
|
|
| - |
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2019 |
|
| 7,720 |
|
| $ | 985.50 |
|
|
| 1.21 |
|
| $ | 752,700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
Exercised |
|
| (1,192 | ) |
|
| 966.16 |
|
|
| 1.43 |
|
|
|
|
|
Expired |
|
| - |
|
|
| - |
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2019 |
|
| 6,528 |
|
| $ | 850.00 |
|
|
| 2.00 |
|
| $ | 1,501,440 |
|
26 |
Table of Contents |
Warrants to Purchase Common Stock
On June 28, 2018, the Company entered into a Securities Purchase Agreement with Aspire Capital Fund, LLC, pursuant to which the Company agreed to sell up to $7.0 million of shares of the Company’s Class A common stock to Aspire Capital, without an underwriter or placement agent. The Company issued to Aspire Capital warrants to purchase 8,000,000 shares of its common stock exercisable for 5 years at an exercise price of $0.38 per share. The warrants were recorded within stockholders’ deficiency. The fair value of the warrants issued on June 28, 2018 was estimated on the date of issuance using the Black-Scholes-Merton Model that uses assumptions noted in the following table. The value of the warrants issued was approximately $1.7 million.
|
| Year Ended June 30, |
| |||||
|
| 2019 |
|
| 2018 |
| ||
Expected term (in years) |
| 5 - 10 |
|
|
| 3 |
| |
Expected stock price volatility |
| 67.34% - 104.11% |
|
|
| 82.36 | % | |
Risk-free interest rate |
| 2.51% - 2.86% |
|
|
| 2.73 | % | |
Expected dividend yield |
|
| 0 |
|
|
| 0 |
|
The following table summarizes the outstanding common stock warrants: | ||||||||||||||||
|
| Warrants |
|
| Weighted Average Exercise Price |
|
| Weighted Average Remaining Contractual Life (Years) |
|
| Aggregate Intrinsic Value |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Outstanding at June 30, 2018 |
|
| 8,000,000 |
|
| $ | 0.38 |
|
|
| 5.0 |
|
| $ | - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Extended |
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
Granted |
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
Exercised |
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
Expired |
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
Outstanding at June 30, 2019 |
|
| 8,000,000 |
|
| $ | 0.38 |
|
|
| 4.0 |
|
| $ | - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Extended |
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
Granted |
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
Exercised |
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
Expired |
|
| - |
|
|
| - |
|
|
| - |
|
|
|
|
|
Outstanding at December 31, 2019 |
|
| 8,000,000 |
|
| $ | 0.38 |
|
|
| 3.5 |
|
| $ | - |
|
As of December 31, 2019 and June 30, 2019, 8,000,000 warrants to purchase shares of the Company’s common stock exercisable for 5 years at an exercise price of $0.38 per share were outstanding.
13. Equity Transactions
Class B common stock
On January 29, 2019, the Company issued 909,090 shares of Class B common stock at the option exercise price of $0.11 per share to Mr. Ehrlich, the Company’s Chairman and CEO (See Note 11. Convertible Note Payable to the condensed consolidated financial statements). As of December 31, 2019 and June 30, 2019, 909,090 shares of Class B common stock were outstanding.
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Series B 5% convertible preferred stock purchase agreement
On October 5, 2018, as modified on May 9, 2019 (see Warrant Restructuring and Additional Issuance Agreement as described below), the Company entered into a Securities Purchase Agreement (“Securities Purchase Agreement”) with one multi-family office for the sale of an aggregate of 2,000 shares of the Company’s newly-created Series B 5% convertible preferred stock ( “Series B preferred stock” or “preferred stock”), for aggregate gross proceeds of approximately $2.0 million. An initial closing for the sale of 1,250 shares of the Series B preferred stock closed on October 9, 2018, and a second closing for the sale of 750 shares of the Series B preferred stock closed on October 12, 2018. Under the Securities Purchase Agreement, the Company also issued to the investors warrants to purchase up to an additional 8,000 shares of preferred stock.
The Series B preferred stock is mandatorily redeemable under certain circumstances and, as such, is presented as a liability on the condensed consolidated balance sheets. The Company has elected to measure the value of its preferred stock using the fair value method with offsetting discounts associated with the fair value allocated to the warrants and for the intrinsic value attributed to the beneficial conversion feature (“BCF”). The fair value of the Series B preferred stock (without the warrants) will be assessed at each subsequent reporting date with changes in fair value recorded in the profit and loss as a separate line item below the “loss from operations” section, in accordance with ASC 480-10-35-5.
The warrants issued in connection with the Series B preferred stock are deemed to be free standing equity instruments and are recorded in permanent equity (additional paid in capital) based on a relative fair value allocation of proceeds (i.e. warrants’ relative fair value to the Series B preferred stock fair value (without the warrants)) with an offsetting discount to the Series B preferred stock. Given that the Series B preferred stock is convertible at any time under these features, the underlying warrant discounts were accreted upon issuance and recorded as interest (resulting in no remaining discount to the Series B preferred stock liability after the issuance).
The Company recorded the October 9, 2018 issuance of 1,250 shares Series B Preferred Stock at approximately $0.7 million and the underlying Series 1, Series 2 and Series 3 warrants at approximately $0.5 million in total by allocating the gross proceeds to Series B preferred stock (without the warrants) and warrants based on their relative fair values or direct valuation as appropriate. The Company recorded BCF of approximately $1.2 million associated with the issuance of the 1,250 shares of Series B preferred stock to additional paid-in capital. The Company then recorded interest of approximately $1.2 million for the BCF and warrant discounts as a first day interest given that the Series B preferred shares can be converted at any time to common stock and given no set term.
The Company recorded the October 12, 2018 issuance of 750 shares Series B Preferred Stock at approximately $0.4 million and the underlying Series 1, Series 2 and Series 3 warrants at approximately $0.3 million in total by allocating the gross proceeds to Series B preferred stock (without the warrants) and warrants based on their relative fair values or direct valuation as appropriate. The Company recorded BCF of approximately $0.7 million associated with the issuance of the 750 shares of Series B preferred stock to additional paid-in capital. The Company then recorded interest of approximately $0.7 million for the BCF and warrant discounts as a first day interest given that Series B preferred shares can be converted at any time to common stock and given no set term.
The issuance costs associated with the Series B preferred stock transaction were attributed to the Series B preferred stock (without the warrants) and to the Series 1, Series 2 and Series 3 warrants based on their relative fair values. The issuance costs attributed to the warrants of $32,000 were reflected as a reduction to additional paid-in capital. The issuances costs associated with the Series B preferred stock liability of $41,000 was recorded immediately as an element of interest cost, which are reflected in interest expense - preferred stock. The Company recognized change in fair value of preferred stock liabilities of $102,000 and $0 under Other (income) expense in the accompanying condensed consolidated Statements of Operations for the six months ended December 31, 2019 and 2018, respectively.
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Underlying Series B preferred stock dividends, paid quarterly, was accrued as interest (given the liability classification of the Series B preferred stock) on a daily basis given fixed dividend terms under the Series B preferred stock. The Company recorded 5% dividend accretion on total outstanding Series B preferred stock at December 31, 2019 and June 30, 2019
The total dividends of approximately $42,000 are treated as interest during the period from October 5, 2018 (date of issuance of preferred stock and warrants) to June 30, 2019. The approximately $17,000 dividends was paid by issuance of Series B preferred stocks, so the remaining accrued dividends of $25,000 was recorded under Preferred stock liability as of June 30, 2019 and was paid by issuance of Series B preferred stocks subsequent to the balance sheet date.
The total dividends of approximately $20,000 are treated as interest expense – preferred stock during the six months ended December 31, 2019. The approximately $24,000 of the Series B preferred stock dividends was paid by issuance of Series B preferred stocks, so the remaining accrued dividends of $21,000 was included at Preferred stock liability as of December 31, 2019.
Terms of the Preferred Stock
The rights and preferences of the preferred stock are set forth in a Certificate of Designation of Preferences, Rights and Limitations of Series B 5% Convertible Preferred Stock filed with the Nevada Secretary of State on October 5, 2018 (the “Certificate of Designation”). Each share of preferred stock has an initial stated value of $1,080 and may be converted at any time at the holder’s option into shares of the Company’s common stock at a conversion price equal of the lower of (i) $0.32 per share and (ii) 85% of the lowest volume weighted average price of the Company’s common stock on a trading day during the ten trading days prior to and ending on, and including, the conversion date. The conversion price may be adjusted following certain triggering events and subsequent equity sales and is subject to appropriate adjustment in the event of stock splits, stock dividends, recapitalization or similar events affecting the Company’s common stock.
The holders of the preferred stock are limited in the amount of stated value of the preferred stock they can convert on any trading day. The conversion cap limits conversions by the holders to the greater of $75,000 and an amount equal to 30% of the aggregate dollar trading volume of the Company’s common stock for the five trading days immediately preceding, and including, the conversion date. However, the conversion cap will be increased if the trading volume in the first 30 minutes of any trading session exceeds certain trailing average daily volume amounts. In addition, the holders of the preferred stock may not convert shares of preferred stock if, after giving effect to the conversion, a holder together with its affiliates would beneficially own in excess of 9.99% of the outstanding shares of the Company’s common stock.
Redemption Rights
Following 30 days after the initial closing, the Company may elect to redeem the preferred stock for 120% of the aggregate stated value then outstanding, plus all accrued but unpaid dividends and all liquidated damages and other amounts due in respect of the preferred stock. The Company’s right to redeem the preferred stock is contingent upon it having complied with a number of conditions, including compliance with its obligations under the Certificate of Designation. Shares of preferred stock generally have no voting rights, except as required by law and except that the Company shall not take certain actions without the consent of the holders of the preferred stock.
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Warrants
Each share of preferred stock was initially sold together with three warrants: (i) a Series 1 warrant, which entitles the holder thereof to purchase 1.25 shares of preferred stock at $982.50 per share, or 2,500 shares of preferred stock in the aggregate for approximately $2.5 million in aggregate exercise price, for a period of up nine months following issuance (later extended to 15 months following issuance), (ii) a Series 2 warrant, which entitles the holder thereof to purchase 1.25 shares of preferred stock at $982.50 per share, or 2,500 shares of preferred stock in the aggregate for approximately $2.5 million in aggregate exercise price, for a period of up to 15 months following issuance, and (iii) a Series 3 warrant, which entitles the holder thereof to purchase 1.50 shares of preferred stock at $982.50 per share, or 3,000 shares of preferred stock in the aggregate for approximately $2.9 million in aggregate exercise price, for a period of up to 24 months following issuance. On May 9, 2019, the Company entered into a warrant restructuring and additional issuance agreement (the “Issuance Agreement”) with the holders of the Series B preferred stock and warrants pursuant to which the Company issued an additional 100 shares of Series B preferred stock and Series 4 warrants to purchase an additional 2,500 shares of preferred stock, and the holders of the Series B preferred stock and warrants agreed to exercise warrants to purchase up to $2.0 million of Series B preferred stock through November 2019 subject to the conditions set forth in the Issuance Agreement. The Series 4 warrant entitles the holder thereof to purchase 2,500 shares of preferred stock at $982.50 per share for approximately $2.5 million in aggregate exercise price, for a period of up to nine months following issuance. In addition, the Company extended the termination date for the Series 1 warrants by six months, and agreed to issue one additional share of preferred stock to the Series B investors for each five shares issued upon the exercise of the existing warrants or Series 4 warrants through November 9, 2019, up to a maximum of 400 shares of preferred stock, all 400 shares of which had been issued as of December 31, 2019. On December 26, 2019, the Company extended the termination date for each series of warrants to December 31, 2021 (see below).
The Series B Preferred shareholders’ warrants held were modified on May 9, 2019 (see Warrant Restructuring and Additional Issuance Agreement described below). Pursuant to this warrant restructuring agreement, the Company had the option to compel these shareholders to exercise each month up to $400,000 of their Series 1 warrants. These warrant holders exercised a total of approximately $2.5 million of their Series 1 to 4 warrants, starting from May 2019 through September 2019. In addition, subject to the satisfaction of certain circumstances, the Company may call for cancellation any or all of the warrants following 90 days after their issuance, for a payment in cash equal to 8% of the aggregate exercise price of the warrants being called. The warrants subject to any such call notice will be cancelled 30 days following the Company’s payment of the call fee, provided that the warrant holders have not exercised the warrants prior to cancellation.
Conversion of preferred stock to common stock
During the year ended June 30, 2019, the two preferred stockholders converted 3,891 shares of Series B preferred stock into 39.2 million shares of common stock. With regard to conversions, the Company reversed Series B preferred stock liability relating to the conversion and recorded as Additional paid-in capital at par value. The Company reversed the amount of approximately $3,068,000 based on the proportion of Series B preferred stock converted relative to the original total issued. As of June 30, 2019, 1,196 shares of Series B 5% convertible preferred stock were outstanding.
During the six months ended December 31, 2019, the two preferred stockholders converted 1,181 shares of Series B preferred stock into 15.0 million shares of common stock. As of December 31, 2019, 1,440 shares of Series B 5% convertible preferred stock were outstanding.
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Warrant Amendment Agreement and Extension of Warrant Terms
On December 26, 2019, the Company entered into a Warrant Amendment Agreement with the holders of the warrants to purchase our Series B preferred stock, pursuant to which we have amended the warrants as follows: (i) to extend the termination date for each warrant to December 31, 2021, and (ii) to adjust the exercise price of each warrant from $982.50 to $850.00 per share of Series B preferred stock. The warrants modification expense of $1,212,000 was computed as the incremental value of the modified warrants over the unmodified warrants on the modification date using a per share price of $0.05 per share, which was the market price on December 26, 2019. Assumptions used in the Black Scholes option-pricing model for these warrants were as follows:
Average risk-free interest rate |
|
| 1.64 | % |
Average expected life-years |
|
| 2 |
|
Expected volatility |
|
| 99.03 | % |
Expected dividends |
|
| 0 | % |
Warrant Restructuring and Additional Issuance Agreement
On May 9, 2019, the Company entered into a Warrant Restructuring and Additional Issuance Agreement (“Issuance Agreement”) with the Series B investors of its Series B preferred stock and warrants to purchase Series B preferred stock. Pursuant to the Issuance Agreement, the Series B investors have agreed, subject to the conditions set forth therein, to exercise existing warrants to purchase 500 shares of preferred stock and to amend the existing warrants to permit the Company to compel the exercise of up to $400,000 of existing warrants each calendar month commencing June 3, 2019 and ending November 1, 2019, or, if earlier, until the aggregate amount of the forced exercises is $2,000,000. As consideration for the Series B investors entering into the Issuance Agreement, the Company has issued 100 shares of preferred stock and warrants to purchase 2,500 shares of preferred stock (“Series 4 warrants”) to the Series B investors. In addition, the Company extended the termination date for the Series 1 warrants issued in October 2018 by six months, and has agreed to issue one additional share of preferred stock to the Series B investors for each five shares issued upon the exercise of the existing warrants or Series 4 warrants through November 9, 2019, up to a maximum of 400 shares of preferred stock, all 400 shares of which had been issued as of December 31, 2019.
The warrants were modified in accordance with ASC 470-50 and, as a result, immediately prior to the modification, the Company recognized a loss of approximately $63,000 to change in fair value of preferred stock liabilities under Other (income) expense in the accompanying condensed consolidated Statements of Operations.
Subsequent to the modification, the Company recognized an expense of approximately $294,000 due to the above modification of Series B preferred stock terms in the accompanying condensed consolidated statements of operations
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The fair value of the Series B convertible preferred stock is measured in accordance with ASC 820 “Fair Value Measurement,” using “Monte Carlo simulation” modeling, incorporating the following inputs:
|
| June 30, 2019 |
|
| May 9, 2019 |
| ||
|
|
|
|
|
|
| ||
Expected dividend yield |
|
| 0.00 | % |
|
| 0.00 | % |
Expected stock-price volatility |
|
| 54.5 | % |
|
| 51.9 | % |
Risk-free interest rate |
|
| 2.18 | % |
|
| 2.43 | % |
Expected term of warrants (years) |
|
| 0.1 |
|
|
| 0.25 |
|
Stock price |
| $ | 535.12 |
|
| $ | 535.12 |
|
Exercise price ( modified on December 26, 2019 as above stated) |
| $ | 850.00 |
|
| $ | 982.50 |
|
14. Fair Value Measurement
The Company has elected to measure its preferred stock using the fair value method. The fair value of the preferred stock is the estimated amount that would be paid to redeem the liability in an orderly transaction between market participants at the measurement date. The Company calculates the fair value of the Series B Preferred stock using a lattice model that takes into consideration the future redemption value on the instrument, which is tied to the Company’s stock price.
These valuations are considered to be Level 3 fair value measurements as the significant inputs are unobservable and require significant management judgment or estimation. Considerable judgment is required in interpreting market data to develop the estimates of fair value. Accordingly, the Company’s estimates are not necessarily indicative of the amounts that the Company, or holders of the instruments, could realize in a current market exchange. Significant assumptions used in the fair value models include: the estimates of the redemption dates; credit spreads; dividend payments; and the market price of the Company’s common stock. The use of different assumptions and/or estimation methodologies could have a material effect on the estimated fair values.
The table below sets forth a reconciliation of the Company’s beginning and ending Level 3 preferred stock liability balance for the period from October 5, 2018 (date of issuance of preferred stock and warrants) to June 30, 2019 and December 31, 2019.
Series B 5% convertible preferred stock liability |
|
|
| |
Balance, July 1, 2018 |
| $ | — |
|
Issuance of preferred stock at fair value |
|
| 1,116,000 |
|
Issuance of preferred stock by exercise of warrants |
|
| 2,895,000 |
|
Conversion of preferred stock to common stock |
|
| (3,068,000 | ) |
Change in fair value of preferred stock due to modification of terms |
|
| (357,000 | ) |
Issuance of 100 shares valued at $535.12 per share Series B Preferred Stock per May 2019 Modification |
|
| 54,000 |
|
Contingent consideration of 400 extra shares |
|
| 214,000 |
|
5% accrued dividend (1) |
|
| 25,000 |
|
Balance, June 30, 2019 |
| $ | 879,000 |
|
|
|
|
|
|
Issuance of preferred stock through accrued dividend, valued at fair value |
|
| 12,000 |
|
Issuance of preferred stock by exercise of warrants |
|
| 639,000 |
|
Conversion of preferred stock to common stock |
|
| (632,000 | ) |
Change in fair value of preferred stock due to modification of terms |
|
| (102,000 | ) |
5% accrued dividend (1) |
|
| 40,000 |
|
Settlement of accrued dividend by issuance of PS |
|
| (24,000 | ) |
Balance, December 31, 2019 |
| $ | 812,000 |
|
(1) | The 5% accrued dividend is reported in interest expense—preferred stock. |
| The total dividends of approximately $40,000 and $25,000 are treated as interest expense – preferred stock during the six months ended December 31, 2019 and during the year ended June 30, 2019, respectively. The Series B preferred stock dividends of $24,000 was paid by issuance of Series B preferred stocks, and the remaining accrued dividends of $41,000 was included at Preferred stock liability as of December 31, 2019. |
15. Subsequent Event
From January 1, 2020 to date of the issuance of these financial statements, the Company issued 300 shares of its Series B 5% convertible preferred stock, for aggregate gross proceeds of approximately $255,000, upon exercise of 300 warrants. In addition, there were 570 preferred stock shares converted to approximately 12.4 million shares of common stock.
On January 22, 2020, the Company filed a complaint against Cummings Properties, LLC in the Superior Court of the Commonwealth of Massachusetts (C.A. No. 20-77CV00101), seeking, among other things, declaratory relief that the lease for the Company’s prior principal executive offices did not automatically extend for an additional five years from September 2018, return of the Company’s security deposit, and damages. This action is in the preliminary stages and the Company is currently unable to determine the probability of the outcome or reasonably estimate the loss or gain, if any.
The Company has evaluated events subsequent to December 31, 2019 through the issuance of these financial statements and determined that there were no additional events requiring disclosure.
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and plan of operations should be read in conjunction with the condensed consolidated financial statements and the notes to those statements included in this Form 10-Q. This discussion includes forward-looking statements that involve risk and uncertainties. You should review our important note about forward-looking statements preceding the condensed consolidated financial statements in Item 1 of this Part I. As a result of many factors, such as those set forth under “Risk Factors” in this Form 10-Q and in our Annual Report on Form 10-K, actual results may differ materially from those anticipated in these forward-looking statements.
Management’s Plan of Operation
Overview
Innovation Pharmaceuticals Inc. is a clinical stage pharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory and antibiotic applications. The Company owns the rights to numerous drug compounds, including Brilacidin, our lead drug in a new class of compounds called defensin-mimetics, and Kevetrin (thioureidobutyronitrile), our lead anti-cancer compound.
Recent Developments
On May 1, 2019, the Company announced receipt of End-of-Phase 2 Meeting Minutes from the Food and Drug Administration (FDA) to align its Phase 3 oral rinse Brilacidin program for the prevention of severe Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation.
On June 6, 2019, the Company announced initiation, in partnership with BDD Pharma, of oral development of Brilacidin in tablet form, utilizing BDD Pharma’s patented OralogiK™ tablet technology, which employs controlled erosion of a time-dependent barrier layer during small intestine transit to provide effective colon targeting.
In June 2019, a scientific abstract presented at the European Hematological Association (EHA) 2019 Annual Meeting was published—”Kevetrin Dampens MYC Expression and Cellular Metabolism in Acute Myeloid Leukemia”—in collaboration with independent cancer researchers.
On July 18, 2019, the Company entered into a license agreement with Alfasigma S.p.A. (“Alfasigma”), an Italy-based global pharmaceutical company, for worldwide rights to develop Brilacidin for localized treatment of ulcerative proctitis/ulcerative proctosigmoiditis (UP/UPS).
On September 20, 2019, the Company amended its Articles of Incorporation to increase the number of authorized shares of Class A common stock from 300 million to 600 million, following stockholder approval.
On December 19, 2019, Dr. Arthur Bertolino resigned as President and Chief Medical Officer and as a member of the Board of Directors of the Company.
In January 2020, the Company completed dosing to subjects in its Phase 1 trial administering oral Brilacidin utilizing delayed release OralogiK™ tablet technology, targeting delivery directly to the colon, being developed for treatment of ulcerative colitis.
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Business Development and Licensing
The Company is actively engaged in business development and licensing initiatives with multiple specialty and global pharmaceutical companies across its entire pipeline of drugs. From time to time, the Company may be party to various indications of interest and term sheets and participate in preliminary discussions and negotiations regarding potential licensing or partnership arrangements. It remains the Company’s primary objective to complete licensing deals, territorial and/or global, to provide access to non-dilutive capital to advance clinical assets forward in the most expeditious and cost-effective manner. The Company can make no assurance that partnerships will occur but is committed toward executing on these potential alliance and partnership opportunities.
In July 2019, the Company entered into a license agreement with Alfasigma, granting Alfasigma the worldwide right to develop, manufacture and commercialize locally-administered Brilacidin for UP/UPS. Under the terms of the license agreement, Alfasigma made an initial payment of $0.4 million to the Company and will make additional payments of up to $24.0 million to the Company based upon the achievement of certain milestones, including a $1.0 million payment due following commencement of the first phase III clinical trial of Brilacidin for UP/UPS and an additional $1.0 million payment upon the filing of a marketing approval application with the U.S. Food and Drug Administration or the European Medicines Agency. In addition, Alfasigma will pay a royalty to the Company equal to six percent of net sales of Brilacidin for UP/UPS, subject to adjustment as provided in the license agreement. Alfasigma is obligated to use commercially reasonable efforts (as defined in the license agreement) to develop, manufacture and commercialize Brilacidin for UP/UPS, and to achieve specified developmental milestones. Alfasigma will be solely responsible for all costs and expenses associated with developing, manufacturing and commercializing Brilacidin for UP/UPS. The license agreement also provides Alfasigma with a right of first refusal for Brilacidin for the treatment of more extensive forms of inflammatory bowel disease (IBD), such as ulcerative colitis and Crohn’s disease, and a right of first negotiation for Brilacidin in other gastrointestinal indications.
Active Clinical Development Programs
Compound | Target/Indication | Clinical Status |
Brilacidin | Oral Mucositis (OM) | Phase 2 Study (completed) Phase 3 in preparation |
| Inflammatory Bowel Disease (IBD) | Phase 2 Proof of Concept Study (completed) Phase 1 Safety/toleration/PK of oral dosage form in preparation |
| ABSSSI (Acute Bacterial Skin and Skin Structure Infection) | Phase 2 (completed) |
Kevetrin | Ovarian Cancer | Phase 2 Study (completed) |
We have no product sales to date and we will not receive any product revenue until we receive approval from the FDA or equivalent foreign regulatory agencies to begin marketing a pharmaceutical product. Milestone payments from our licensee are also dependent on clinical/regulatory milestones. We are actively engaged in business development for partnering our drug for IBD and OM. Developing pharmaceutical products, however, is a lengthy and very expensive process. Assuming we do not encounter any unforeseen safety or efficacy issues during the course of developing our product candidates, we do not expect to complete the development of a product candidate for several years, if ever.
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The Company devotes most of its efforts and resources on its compounds Brilacidin and Kevetrin, which are in clinical development. We anticipate using our expertise to manage and perform what we believe are the most critical aspects of the product development process which include: (i) design and oversight of clinical trials; (ii) development and execution of strategies for the protection and maintenance of intellectual property rights; and (iii) interactions with regulatory authorities domestically and internationally. We expect to concentrate on product development and engage in a limited way in product discovery, avoiding the significant investment of time and financial resources that is generally required for a promising compound to be identified and brought into clinical trials.
Set forth below is an overview of our most recent research and development efforts on Brilacidin and Kevetrin through the date of this Quarterly Report on Form 10-Q is submitted:
Brilacidin
Two trials of topical/locally administered Brilacidin have been completed: a double-blind Phase 2 clinical trial of Brilacidin for the treatment of Oral Mucositis (OM); and an open-label Phase 2 Proof-of-Concept (P-o-C) trial of Brilacidin for the treatment of Ulcerative Proctitis/Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). Brilacidin for the treatment of UP/UPS has been licensed to Alphasigma. Appropriate regulatory and other activities aimed at moving the OM program forward into further clinical testing are currently underway.
Topical Administration (Oral Mucositis; IBD,UP/UPS)
Oral Mucositis (OM) study — In this randomized, double-blind Phase 2 study of Brilacidin for the prevention and control of OM in patients receiving chemoradiation for treatment of Head and Neck Cancer (HNC), analysis of patients who received at least 55 Gy cumulative units of radiation showed that Brilacidin markedly reduced the rate of severe OM (WHO Grade ≥ 3), delayed onset of severe OM and decreased duration of severe OM. The Company made available, in a blog published on its website, a comparative data table (based on public information) showing Brilacidin compares favorably to other compounds in development for preventing and treating severe OM. The Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting concerning the continuing development of Brilacidin oral rinse to decrease the incidence of severe OM in HNC patients receiving chemoradiation. Both parties agreed to an acceptable Brilacidin Phase 3 development pathway, including studying Brilacidin oral rinse effects on severe OM when cisplatin, the preferred chemotherapy regimen in HNC care, is administered in higher concentrations (80-100 mg/m2) every 21 days, and at lower concentrations (30-40 mg/m2) administered weekly as part of the chemoradiation regimen.
IBD, UP/UPS study —(see Note 7. Exclusive License Agreement to the condensed consolidated financial statements). This Phase 2a trial comprises three sequential cohorts, with progressive dose escalation by cohort—cohort A (6 patients) - 50 mg, cohort B (6 patients) - 100 mg, and cohort C (5 patients) - 200 mg, respectively. Treatment with Brilacidin by daily enema administration was performed for 42 days. The primary efficacy endpoint of clinical remission (accounting for stool frequency, rectal bleeding and endoscopy findings subscores) was met by the majority of patients across the cohorts. Brilacidin was generally well-tolerated. Patient quality of life (as assessed by the short inflammatory bowel disease questionnaire, or SIBDQ) showed notable improvements. Limited systemic exposure to Brilacidin was demonstrated as measured by plasma Brilacidin concentrations. Future development work with locally-administered Brilacidin for UP/UPS will be conducted by Alfasigma.
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Oral Administration: (IBD,UC)
To obtain maximum value of the Brilacidin-IBD asset, the Company is developing the drug candidate for oral dosing.
IBD, Ulcerative Colitis (UC) — Brilacidin is also being developed as a treatment in more extensive forms of IBD, with formulation development plans including oral tablets first aimed for the treatment of ulcerative colitis and then Crohn’s disease. The Company has partnered with BDD Pharma for oral development of Brilacidin in tablet form utilizing BDD Pharma’s patented OralogiK™ tablet technology to achieve selective delivery of Brilacidin to the colon. Initial clinical testing in a Phase 1 single-dose escalation trial was conducted in January 2020, which tested a radio (gamma) isotope labeled Brilacidin oral formulation in healthy volunteers to assess targeting, dispersion, safety, toleration, and the pharmacokinetic profile. Following multidose testing in healthy volunteers, a placebo-controlled Phase 2 clinical trial in UC patients would be targeted to begin in the second half of calendar year 2020. We aim to design this patient clinical trial to firmly anchor proof-of-concept for treatment of ulcerative colitis.
As stated above, we see significant opportunities in treating Oral Mucositis and IBD with Brilacidin. The clinical data also suggest that other inflammatory conditions including various dermatology disorders and conditions may, likewise, be treated locally and efficaciously with Brilacidin.
Intravenous administration: ABSSSI
In February 2016, the Company submitted a Special Protocol Assessment (SPA) request, along with a final protocol, to the FDA, for a Phase 3 clinical trial of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). We received from the FDA comments and considerations for incorporation into our study design. Management decided to delay its response to FDA due to the low price per share of our common stock and the approximately $30 million costs required for this study. Our strategy, for now, is to achieve success with other trials and attract partnering opportunities that may provide significant upfront payments and milestone payments, which can then be used to fund the ABSSSI program. We see ABSSSI as the appropriate gateway indication in infectious diseases, enabling potential further studies of Brilacidin’s use for implant coating and biofilm infections.
Expenditures on Brilacidin were approximately $0.2 million and $0.7 million during the three months ended December 31, 2019 and 2018, respectively, and approximately $0.4 million and $1.1 million during the six months ended December 31, 2019 and 2018, respectively.
Kevetrin
The Company has completed a Phase 2a trial of Kevetrin in treating late-stage Ovarian Cancer. The main objective of the trial focused on confirming the modulation by Kevetrin of p53 pathways in tumors, as well as monitoring the response of tumors to the treatment. The study was successful in demonstrating modulation of p53 directly in ovarian cancer tumor tissue in patients. Pharmacokinetic data collected on Kevetrin during the Phase 1 clinical trial demonstrated that the compound has a short half-life of approximately two hours. This short half-life makes it a compelling candidate for an oral drug delivery treatment for the main purpose of allowing simple daily, or multiple-times daily administrations within or outside the hospital setting. Compared to injectable or intravenous treatments, oral therapy is the preferred drug delivery method of patients. Preliminary laboratory studies are encouraging and support the potential of developing an oral formulation, but there are no assurances made or implied that the Company will be successful in completing development of an oral formulation. Toxicology studies for the oral formulation of Kevetrin are approximately half completed, with the remainder of this work to be completed when the Company secures additional financial resources. Next steps in the development of Kevetrin include: completing bridging toxicology work for an oral formulation; developing the oral formulation (pill or tablet); requesting an FDA meeting to discuss trial results to date and the design of future trials; and performing a dosing safety study in healthy volunteers once the oral formulation has been developed. Once completed, these steps would likely quickly lead to Phase 2 testing of oral Kevetrin in both solid tumors and leukemias, with ovarian cancer likely continuing to be the lead indication.
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Expenditures on Kevetrin were insignificant during the both the quarters and six months ended December 31, 2019 and 2018.
We have no product sales to date and we will not receive any product revenue until we receive approval from the FDA or equivalent foreign regulatory agencies to begin marketing a pharmaceutical product. Developing pharmaceutical products, however, is a lengthy and very expensive process. Assuming we do not encounter any unforeseen safety or efficacy issues during the course of developing our product candidates, we do not expect to complete the development of a product candidate for several years, if ever.
Going Concern
We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern. As of December 31, 2019, we had approximately $0.2 million in cash compared to $0.6 million of cash as of June 30, 2019. The amount of cash and cash equivalents on the balance sheet as of the date of this filing is approximately $0.4 million and is not adequate to fund our operations. The Company’s only revenue during the six months ended December 31, 2019 is $0.4 million under the terms of the License Agreement with Alfasigma (see Note 7. Exclusive License Agreement to the condensed consolidated financial statements). We have no product sales as we do not have any products in the market and will continue to not have significant revenues until we begin to market our products after we have obtained the necessary FDA approval. As a result, the Company expects to continue to incur losses over the next 12 months from the date of this filing. Accordingly, the Company’s planned operations, including total budgeted expenditures of approximately $11.5 million for the next twelve months, raise doubt about its ability to continue as a going concern for the next 12 months. If we are not able to continue as a going concern, it is likely that holders of our common stock will lose all of their investment. Our condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
To continue as a going concern, we must secure additional funding to support our current operating plan. The Company expects to seek to obtain additional funding through business development activities (i.e. licensing and partnerships), such as the license agreement with Alfasigma, and future equity issuances. There can be no assurance as to the availability or terms upon which such financing and capital might be available.
Critical Accounting Policies and Estimates
Management’s discussion and analysis of financial condition and results of operations are based upon our accompanying condensed consolidated financial statements, which have been prepared in conformity with U.S. GAAP, and which requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. We base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances. These estimates are the basis for our judgments about the carrying values of assets and liabilities, which in turn may impact our reported revenue and expenses. Our actual results could differ significantly from these estimates under different assumptions or conditions.
37 |
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Please see Note 3 of the condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for the summary of significant accounting policies. In addition, please see Part II, Item 7, “Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K for the year ended June 30, 2019. There have been no material changes to our critical accounting policies and estimates since our Annual Report on Form 10-K for the year ended June 30, 2019.
Recently Issued Accounting Pronouncements
Please see Note 3 to the condensed consolidated financial statements, Significant Accounting Policies and Recent Accounting Pronouncements, for a discussion of recent accounting pronouncements and their effect, if any, on our condensed consolidated financial statements.
Results of Operations
We expect to incur losses from operations for the next few years. We expect to incur increasing research and development expenses, including expenses related to additional clinical trials for our proprietary programs. Based upon our expected rate of expenditures over the next 12 months, we expect to raise additional capital through, among other things, the sale of equity or debt securities to meet all of our anticipated obligations for our current operations through our fiscal year end of June 30, 2020. However, continuing operations for the next 12 months from the date of this filing is very much dependent upon our ability to raise equity from existing or new financing sources. There can be no assurance as to the availability or terms upon which such financing and capital might be available.
For the three months ended December 31, 2019 and 2018
Revenue
We generated no revenue for the three months ended December 31, 2019 and 2018, respectively.
We incurred operating expenses of approximately $1.3 million and $2.0 million for the three months ended December 31, 2019 and 2018, respectively.
Research and Development Expenses for Proprietary Programs
Below is a summary of our research and development expenses for our proprietary programs by categories of costs for the three months ended December 31, 2019 and 2018, respectively (rounded to nearest thousand):
|
| For the three months ended |
|
| Change |
| ||||||||||
|
| December 31, |
|
| 2019 vs. 2018 |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| $ |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Clinical studies and development research |
| $ | 386,000 |
|
| $ | 797,000 |
|
|
| (411,000 | ) |
|
| -52 | % |
Officers’ payroll and payroll tax expenses related to R&D Department |
|
| 118,000 |
|
|
| 113,000 |
|
|
| 5,000 |
|
|
| 4 | % |
Employees payroll and payroll tax expenses related to R&D Department |
|
| 70,000 |
|
|
| 111,000 |
|
|
| (41,000 | ) |
|
| -37 | % |
Stock-based compensation - officers |
|
| 109,000 |
|
|
| 226,000 |
|
|
| (117,000 | ) |
|
| -52 | % |
Stock-based compensation - employees |
|
| 22,000 |
|
|
| 49,000 |
|
|
| (27,000 | ) |
|
| -55 | % |
Stock-based compensation - consultants |
|
| 7,000 |
|
|
| 12,000 |
|
|
| (5,000 | ) |
|
| -42 | % |
Depreciation and amortization expenses |
|
| 94,000 |
|
|
| 91,000 |
|
|
| 3,000 |
|
|
| 3 | % |
Total |
| $ | 806,000 |
|
| $ | 1,399,000 |
|
|
| (593,000 | ) |
|
| -42 | % |
38 |
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Research and development expenses for proprietary programs decreased during the three months ended December 31, 2019 primarily due to less spending on our programs. Clinical studies and development expenses may decrease in future reporting periods depending on the Company’s current and future financial liquidity.
Officers’ payroll increased during the three months ended December 31, 2019 primarily due to the increase in officers’ payroll tax expense during the three months ended December 31, 2019. On December 19, 2019, Arthur P. Bertolino resigned as President and Chief Medical Officer and as a member of the Board of Directors of the Company, effective immediately.
Employees payroll and payroll tax expenses decreased during the three months ended December 31, 2019 related to fewer employees engaged in preclinical development, which led to the decrease in employees’ payroll during the three months ended December 31, 2019.
Stock-based compensation - officers decreased during the three months ended December 31, 2019 primarily because of lower stock-based compensation expense for an award granted to our President and Chief Medical Officer on September 1, 2018 compared to an award granted on September 1, 2019.
Stock-based compensation - employees decreased during the three months ended December 31, 2019 due to valuation of stock awards vesting being lower to employees during the quarter ended December 31, 2019 compared with the same period in 2018.
Stock-based compensation - consultants decreased during the three months ended December 31, 2019 due to less stock awards were granted to consultants during the quarter ended December 31, 2019 compared with the same period in 2018.
Our research and development expenses include costs related to preclinical and clinical trials, outsourced services and consulting, officers’ payroll and related payroll tax expenses, other wages and related payroll tax expenses, stock-based compensation, depreciation and amortization expenses. We manage our proprietary programs based on scientific data and achievement of research plan goals. Our scientists record their time to specific projects when possible; however, many activities occurring simultaneously benefit multiple projects and cannot be readily attributed to a specific project. Accordingly, the accurate assignment of time and costs to a specific project is difficult and may not give a true indication of the actual costs of a particular project. As a result, we do not report costs on an individual program basis.
39 |
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General and Administrative Expenses
General and administrative expenses consist mainly of compensation and associated fringe benefits not included in cost of research and development expenses for proprietary programs and include other management, business development, accounting, information technology and administration costs, including patent filing and prosecution, recruiting, consulting and professional services, travel and meals, facilities, depreciation and other office expenses.
Below is a summary of our general and administrative expenses for the three months ended December 31, 2019 and 2018, respectively (rounded to nearest thousand):
|
| For the three months ended |
|
| Change |
| ||||||||||
|
| December 31, |
|
| 2019 vs. 2018 |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| $ |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Insurance and health expense |
| $ | 124,000 |
|
| $ | 124,000 |
|
|
| - |
|
|
| 0 | % |
Rent and utility expense |
|
| 30,000 |
|
|
| 61,000 |
|
|
| (31,000 | ) |
|
| -51 | % |
Other G&A |
|
| 200,000 |
|
|
| 247,000 |
|
|
| (47,000 | ) |
|
| -19 | % |
Total |
| $ | 354,000 |
|
| $ | 432,000 |
|
|
| (78,000 | ) |
|
| -18 | % |
General and administrative expenses decreased during the three months ended December 31, 2019 primarily related to decreases in promotion, advertising and office expenses.
Officers’ Payroll and Payroll Tax Expenses
Below is a summary of our Officers’ payroll and payroll tax expenses for the three months ended December 31, 2019 and 2018, respectively (rounded to nearest thousand):
|
| Three months ended |
|
| Change |
| ||||||||||
|
| December 31, |
|
| 2019 vs. 2018 |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| $ |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Officers’ payroll and payroll tax expenses |
| $ | 118,000 |
|
| $ | 118,000 |
|
|
| - |
|
|
| 0 | % |
There was no change in the officers’ payroll and payroll tax expenses during the three months ended December 31, 2019.
Professional Fees
Below is a summary of our Professional fees for the three months ended December 31, 2019 and 2018, respectively (rounded to nearest thousand):
|
| Three months ended |
|
| Change |
| ||||||||||
|
| December 31, |
|
| 2019 vs. 2018 |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| $ |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Audit, legal and professional fees |
| $ | 67,000 |
|
|
| 45,000 |
|
|
| 22,000 |
|
|
| 49 | % |
Professional fees increased during the three months ended December 31, 2019 primarily related to increase in legal fees and other professional fees for more legal review of various contracts in 2019.
40 |
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Other Income (Expense)
Below is a summary of our other income (expense) for the three months ended December 31, 2019 and 2018, respectively (rounded to nearest thousand):
|
| Three months ended |
|
| Change |
| ||||||||||
|
| December 31, |
|
| 2019 vs. 2018 |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| $ |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Other Income |
| $ | - |
|
|
| 40,000 |
|
| $ | (40,000 | ) |
|
| -100 | % |
Interest expense-debt |
|
| (48,000 | ) |
|
| (50,000 | ) |
|
| 2,000 |
|
|
| -4 | % |
Interest expense-preferred stock liability |
|
| (20,000 | ) |
|
| (1,975,000 | ) |
|
| 1,955,000 |
|
|
| -99 | % |
Warrants modification expense |
|
| (1,212,000 | ) |
|
| - |
|
|
| (1,212,000 | ) |
|
| - | % |
Other Income (Expense), net |
| $ | (1,280,000 | ) |
|
| (1,985,000 | ) |
|
| 705,000 |
|
|
| -36 | % |
Other income decreased during the three months ended December 31, 2019 due to no disposal of lab equipment during the quarter ended December 31, 2019 compared with the same period in 2018.
There was a decrease in interest expenses paid on the note payable – related party, because the decrease in the note payable due to the Company’s Chairman and CEO since January 29, 2019 (see Note 11. Convertible Note Payable - Related Party to the condensed consolidated financial statements).
There was a decrease in interest expense – preferred stock liability of approximately $1,975,000 relating to the issuance of Series B preferred stock that has been recorded as a liability on the accompanying balance sheets. The interest expense – preferred stock liability of approximately $20,000 during the three months ended December 31, 2019 represented the 5% dividend accrued for the Series B preferred stock for the three months ended December 31, 2019.
There was an increase in warrants modification expense of approximately $1,212,000 relating to the extension of the termination date for each warrant to December 31, 2021 (see 13. Equity Transactions to the condensed consolidated financial statements).
Net Losses
We incurred net losses of $2.6 million and $4.0 million for the three months ended December 31, 2019 and 2018, respectively because of the above-mentioned factors.
For the six months ended December 31, 2019 and 2018
Revenue
We generated revenue of $0.4 million and $0 million for the six months ended December 31, 2019 and 2018, respectively. Revenue during the six months ended December 31, 2019 represented the initial non-refundable payment from the exclusive license agreement signed with Alfasigma S.p.A., a global pharmaceutical company (see Note 7. Exclusive License Agreement to the condensed consolidated financial statements).
41 |
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We incurred operating expenses of approximately $2.7 million and $4.0 million for the six months ended December 31, 2019 and 2018, respectively.
Research and Development Expenses for Proprietary Programs
Below is a summary of our research and development expenses for our proprietary programs by categories of costs for the six months ended December 31, 2019 and 2018, respectively (rounded to nearest thousand):
|
| For the six months ended |
|
| Change |
| ||||||||||
|
| December 31, |
|
| 2019 vs. 2018 |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| $ |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Clinical studies and development research |
| $ | 676,000 |
|
| $ | 1,414,000 |
|
|
| (738,000 | ) |
|
| -52 | % |
Officers’ payroll and payroll tax expenses related to R&D Department |
|
| 232,000 |
|
|
| 346,000 |
|
|
| (114,000 | ) |
|
| -33 | % |
Employees payroll and payroll tax expenses related to R&D Department |
|
| 140,000 |
|
|
| 295,000 |
|
|
| (155,000 | ) |
|
| -53 | % |
Stock-based compensation - officers |
|
| 298,000 |
|
|
| 398,000 |
|
|
| (100,000 | ) |
|
| -25 | % |
Stock-based compensation - employees |
|
| 60,000 |
|
|
| 93,000 |
|
|
| (33,000 | ) |
|
| -35 | % |
Stock-based compensation - consultants |
|
| 16,000 |
|
|
| 25,000 |
|
|
| (9,000 | ) |
|
| 0 | % |
Depreciation and amortization expenses |
|
| 187,000 |
|
|
| 185,000 |
|
|
| 2,000 |
|
|
| 1 | % |
Total |
| $ | 1,609,000 |
|
| $ | 2,756,000 |
|
|
| (1,147,000 | ) |
|
| -42 | % |
Research and development expenses for proprietary programs decreased during the six months ended December 31, 2019 primarily due to less spending on our programs. Clinical studies and development expenses may decrease in future reporting periods depending on the Company’s current and future financial liquidity.
Officers’ payroll decreased during the six months ended December 31, 2019 because the Company’s President of Research resigned in September 2018, which led to the decrease in officers’ payroll during the six months ended December 31, 2019.
Employees payroll and payroll tax expenses decreased during the six months ended December 31, 2019 related to fewer employees engaged in preclinical development, which led to the decrease in employees’ payroll during the six months ended December 31, 2019.
Stock-based compensation - officers decreased during the six months ended December 31, 2019 primarily because of lower stock-based compensation expense for an award granted to our President and Chief Medical Officer on September 1, 2018 compared to an award granted on September 1, 2019.
Stock-based compensation - employees decreased during the six months ended December 31, 2019 due to valuation of stock awards vesting being lower to employees during the six months ended December 31, 2019 compared with the same period in 2018.
Stock-based compensation - consultants decreased during the six months ended December 31, 2019 due to less stock awards were granted to consultants during the six months ended December 31, 2019 compared with the same period in 2018.
42 |
Table of Contents |
Our research and development expenses include costs related to preclinical and clinical trials, outsourced services and consulting, officers’ payroll and related payroll tax expenses, other wages and related payroll tax expenses, stock-based compensation, depreciation and amortization expenses. We manage our proprietary programs based on scientific data and achievement of research plan goals. Our scientists record their time to specific projects when possible; however, many activities occurring simultaneously benefit multiple projects and cannot be readily attributed to a specific project. Accordingly, the accurate assignment of time and costs to a specific project is difficult and may not give a true indication of the actual costs of a particular project. As a result, we do not report costs on an individual program basis.
General and Administrative Expenses
General and administrative expenses consist mainly of compensation and associated fringe benefits not included in cost of research and development expenses for proprietary programs and include other management, business development, accounting, information technology and administration costs, including patent filing and prosecution, recruiting, consulting and professional services, travel and meals, facilities, depreciation and other office expenses.
Below is a summary of our general and administrative expenses for the six months ended December 31, 2019 and 2018, respectively (rounded to nearest thousand):
|
| For the six months ended |
|
| Change |
| ||||||||||
|
| December 31, |
|
| 2019 vs. 2018 |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| $ |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Insurance and health expense |
| $ | 252,000 |
|
| $ | 255,000 |
|
|
| (3,000 | ) |
|
| -1 | % |
Rent and utility expense |
|
| 68,000 |
|
|
| 122,000 |
|
|
| (54,000 | ) |
|
| -44 | % |
Other G&A |
|
| 299,000 |
|
|
| 315,000 |
|
|
| (16,000 | ) |
|
| -5 | % |
Total |
| $ | 619,000 |
|
| $ | 692,000 |
|
|
| (73,000 | ) |
|
| -11 | % |
General and administrative expenses decreased during the six months ended December 31, 2019 primarily related to decreases in promotion, advertising and office expenses.
Officers’ Payroll and Payroll Tax Expenses
Below is a summary of our Officers’ payroll and payroll tax expenses for the six months ended December 31, 2019 and 2018, respectively (rounded to nearest thousand):
|
| For the six months ended |
|
| Change |
| ||||||||||
|
| December 31, |
|
| 2019 vs. 2018 |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| $ |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Officers’ payroll and payroll tax expenses |
| $ | 236,000 |
|
| $ | 241,000 |
|
|
| (5,000 | ) |
|
| -2 | % |
Officers’ payroll and payroll tax expenses for the Company slightly decreased during the six months ended December 31, 2019.
43 |
Table of Contents |
Professional Fees
Below is a summary of our Professional fees for the six months ended December 31, 2019 and 2018, respectively (rounded to nearest thousand):
|
| For the six months ended |
|
| Change |
| ||||||||||
|
| December 31, |
|
| 2019 vs. 2018 |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| $ |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Audit, legal and professional fees |
| $ | 222,000 |
|
|
| 304,000 |
|
|
| (82,000 | ) |
|
| -27 | % |
Professional fees decreased during the six months ended December 31, 2019 primarily related to higher legal fees and other professional fees in connection with negotiation of the Securities Purchase Agreement executed in October 2019, partially offset by increased legal review of various contracts in 2019.
Other Income (Expense)
Below is a summary of our other income (expense) for the six months ended December 31, 2019 and 2018, respectively (rounded to nearest thousand):
|
| For the Six months ended |
|
| Change |
| ||||||||||
|
| December 31, |
|
| 2019 vs. 2018 |
| ||||||||||
|
| 2019 |
|
| 2018 |
|
| $ |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Other income |
|
| - |
|
|
| 40,000 |
|
|
| (40,000 | ) |
|
| -100 | % |
Interest expense – debt |
|
| (96,000 | ) |
|
| (101,000 | ) |
|
| 5,000 |
|
|
| -5 | % |
Interest expense – preferred stock liability |
|
| (40,000 | ) |
|
| (1,975,000 | ) |
|
| 1,935,000 |
|
|
| -98 | % |
Change in fair value of preferred stock liability |
|
| 102,000 |
|
|
| - |
|
|
| 102,000 |
|
|
| - | % |
Impairment expense of operating lease |
|
| (643,000 | ) |
|
| - |
|
|
| (643,000 | ) |
|
| - | % |
Warrants modification expense |
|
| (1,212,000 | ) |
|
| - |
|
|
| (1,212,000 | ) |
|
| - | % |
Other Income (Expense), net |
| $ | (1,889,000 | ) |
| $ | (2,036,000 | ) |
| $ | 147,000 |
|
|
| -7 | % |
Other income decreased during the six months ended December 31, 2019 due to no disposal of lab equipment during the six months ended December 31, 2019 compared with the same period in 2018.
There was a decrease in interest expenses paid on the note payable – related party, because the decrease in the note payable due to the Company’s Chairman and CEO since January 29, 2019 (see Note 11. Convertible Note Payable - Related Party to the condensed consolidated financial statements).
There was a decrease in interest expense – preferred stock liability of approximately $1,975,000 relating to the issuance of Series B preferred stock that has been recorded as a liability on the accompanying balance sheets. The interest expense – preferred stock liability of approximately $20,000 during the six months ended December 31, 2019 represented the 5% dividend accrued for the Series B preferred stock for the six months ended December 31, 2019.
There was an increase in change in value related to the Series B preferred stock (see Note 14. Fair Value Measurement to the condensed consolidated financial statements).
44 |
Table of Contents |
There was an increase in impairment expense of operating lease of approximately $643,000, related to the operating lease right-of-use asset (see Note 8 – Operating Leases to the condensed consolidated financial statements).
There was an increase in warrants modification expense of approximately $1,212,000 relating to the extension of the termination date for each warrant to December 31, 2021 (see 13. Equity Transactions to the condensed consolidated financial statements).
Net Losses
We incurred net losses of $4.2 million and $6.0 million for the six months ended December 31, 2019 and 2018, respectively because of the above-mentioned factors.
Liquidity and Capital Resources
Projected Future Working Capital Requirements - Next 12 Months
As of December 31, 2019, we had approximately $0.2 million in cash compared to $0.6 million of cash as of June 30, 2019. The amount of cash and cash equivalents on the balance sheet as of the date of this filing is approximately $0.4 million and is not adequate to fund our operations. We anticipate that future budget expenditures, based upon us obtaining the adequate financial resources to enable us to operate at our budgeted operations, will be approximately a total of $11.5 million for the next twelve months, including approximately $7.5 million for clinical activities, supportive research, and drug product. This assessment is based on current estimates and assumptions regarding our clinical development programs and business needs. Actual working capital requirements could differ materially from this projection.
Therefore, our current projected budgeted average monthly cash flow shortfall is anticipated to average approximately $1 million per month for the next 12 months from the date of the filing of this report. We are working to reduce our projected monthly cash flow shortfall and we are currently seeking new sources of financing to fund our additional research and development work and general and administrative expenses over the next 12 months from the date of this filing. We have the ability to delay incurring certain operating expenses in the next 12 months, which could reduce our cash flow shortfall, if needed.
We do not currently satisfy the requirements for use of Form S-3 for the primary offerings of our securities but we may utilize Form S-1 to register the future issuance of our securities. The current primary potential source of cash available to us is proceeds from the exercise of outstanding warrants to purchase shares of our Series B preferred stock, which warrants we issued in October 2018 and May 2019. In addition, we may receive payments upon the achievement of milestones pursuant to our license agreement with Alfasigma or similar license agreements in the future. There can be no assurance of the exercise of these warrants or the receipt of these milestone payments in the future.
Our ability to successfully raise sufficient funds through the sale of equity securities, and to meet our current and future operating expenditures is uncertain and subject to market conditions generally, the market for our common stock, and our ability to sell our common stock and other risks. These factors, among others, raise substantial doubt about our ability to continue as a going concern for the next 12 months. In the event that we are unable to raise sufficient additional funds, we may be required to delay, reduce or severely curtail our operations or otherwise impede our on-going business efforts, which could have a material adverse effect on our future business, operating results, financial condition and long-term prospects. In addition, we may be forced to cease all operations, in which event investors may lose their entire investment in the Company. Our condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. See Note 2. Going Concern and Liquidity to the condensed consolidated financial statements included elsewhere in this report for a further discussion of our liquidity and the conditions and events which raise substantial doubt regarding our ability to continue as a going concern for the next 12 months.
45 |
Table of Contents |
The Company does not currently satisfy the conditions for use of Form S-3 for primary offerings of securities, and the Company will not be able to use a registration statement on Form S-3 to raise capital until the aggregate market value of the Company’s common equity held by non-affiliates equals or exceeds $75 million or the Company lists its common stock on a national securities exchange such as Nasdaq or the NYSE. The Company will utilize Form S-1 to register the sale of its securities, although Form S-1 offers less flexibility on the timing and types of offerings compared to Form S-3.
Cash Flows
The following table provides information regarding our cash position, cash flows and capital expenditures (rounded to nearest thousand):
| Six Months Ended |
| Change | |||||||||
| December 31, |
| Increase/ | |||||||||
| 2019 |
| 2018 |
| (Decrease) | |||||||
| % |
| ||||||||||
Net cash used in operating activities |
| $ | (1,444,000 | ) |
| $ | (3,973,000 | ) |
| (64 | )% | |
Net cash provided by investing activities |
| (45,000 | ) |
| 4,000 |
| (1225 | )% | ||||
Net cash provided by financing activities |
| 1,097,000 |
| 2,293,000 |
| (52 | )% | |||||
Net decrease in cash |
| $ | (392,000 | ) |
| $ | (1,676,000 | ) |
| (77 | )% |
The decrease in net cash used in operating activities of $2.5 million versus the prior-year six-month period was mainly due to decreases in our losses from operations of $3.4 million, largely attributable to increase in initial non-refundable payment from the exclusive license agreement signed with Alfasigma S.p.A., a global pharmaceutical company (see Note 7. Exclusive License Agreement to the condensed consolidated financial statements) and less spending for research and development expenses.
Our operating activities used cash of $1.4 million and $4.0 million for the six months ended December 31, 2019 and 2018, respectively. The use of cash in these periods principally resulted from our losses from operations, mentioned above, as adjusted for non-cash charges for stock-based compensation, patent amortization change in fair value of preferred stock, interest expense on preferred stock, impairment expense of operating lease, and changes in our working capital accounts.
Investing activities
The decrease in net cash provided by investing activities versus the prior-year six-month period was due to decrease in sales proceeds of property, plant and equipment.
Financing activities
During the six months ended December 31, 2019 and 2018, our total net financing activities provided cash of $1.1 million and $2.3 million, respectively.
During the six months ended December 31, 2019 and 2018, we raised approximately $1.2 million and $2.4 million in net cash proceeds from exercise of warrants and from issuance of Series B preferred stock and exercise of warrants, respectively.
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Requirement for Additional Working Capital
The Company, dependent on its future sale of its securities, plans to incur total expenses of approximately $11.5 million for the next 12 months, including approximately $7.5 million for clinical activities, supportive research, and drug product development. The Company has limited experience with pharmaceutical drug development. As such, the budget estimate may not be accurate. In addition, the actual work to be performed is not known at this time, other than a broad outline, as is normal with any scientific work. As further work is performed, additional work may become necessary or a change in plans or workload may occur. Such changes may have an adverse impact on our estimated budget and on our projected timeline of drug development.
The Company will be unable to proceed with its planned drug development programs, meet its administrative expense requirements, capital costs, or staffing costs without raising additional capital in the next several months. The current primary potential source of cash available to the Company is proceeds from the exercise of warrants to purchase shares of Series B preferred stock, which warrants were issued in October 2018 and May 2019. In addition, the Company may receive payments upon the achievement of milestones pursuant to its license agreement with Alfasigma or similar license agreements in the future. There can be no assurance of the exercise of warrants or the receipt of milestone payments by the Company in the future.
During the six months ended December 31, 2019, the Company issued 1,192 shares of its Series B 5% convertible preferred stock, for aggregate gross proceeds of $1.2 million, upon exercise of 1,192 warrants. As of December 31, 2019, Series 1-4 warrants to purchase 6,528 shares of Series B preferred stock were outstanding. As the Company cannot be certain the remaining warrants will be exercised, there can be no assurance those funds or other funds will be available when needed (see Note 13. Equity Transactions to the condensed consolidated financial statements, included in Part I, Item 1 of this Quarterly Report on Form 10-Q).
In the event that we are unable to raise sufficient capital, we may be required to delay, reduce or severely curtail our operations or otherwise impede our on-going business efforts, which could have a material adverse effect on our future business, operating results, financial condition and long-term prospects. The Company expects to seek to obtain additional funding through business development activities (i.e. licensing and partnerships) and future equity issuances. There can be no assurance as to the availability or terms upon which such financing and capital might be available. The accompanying condensed consolidated financial statements do not include any adjustments related to the carrying values and classifications of assets and liabilities that would be necessary should the Company be unable to continue as a going concern.
Commitments and Contingencies
Please see Note 9 to the condensed consolidated financial statements, Commitments and Contingencies, for a discussion of recent contractual commitments and contingent liability - disputed invoices.
Off-Balance Sheet Arrangements
The Company does not have any off-balance sheet arrangements, as defined in Item 304(a)(4)(ii) of Regulation S-K under the Securities Exchange Act of 1934, as amended.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We have established disclosure controls and procedures to ensure that the information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms and that such information is accumulated and communicated to management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
As of December 31, 2019, management, with the participation of our principal executive officer and principal financial officer, carried out an evaluation of the effectiveness of the design and operation of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act). Based on such evaluation, as of December 31, 2019, the principal executive officer and principal financial officer of the Company has concluded that the Company’s disclosure controls and procedures are effective.
Changes in Internal Controls
There have been no changes in our internal control over financial reporting during the quarter ended December 31, 2019, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.
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On January 22, 2020, the Company filed a complaint against Cummings Properties, LLC in the Superior Court of the Commonwealth of Massachusetts (C.A. No. 20-77CV00101), seeking, among other things, declaratory relief that the lease for the Company’s prior principal executive offices did not automatically extend for an additional five years from September 2018, return of the Company’s security deposit, and damages. This action is in the preliminary stages and the Company is currently unable to determine the probability of the outcome or reasonably estimate the loss or gain, if any.
Our operations and financial results are subject to various risks and uncertainties, including those described in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended June 30, 2019, which could adversely affect our business, financial condition, results of operations, cash flows, and the trading price of our common and capital stock. There have been no material changes to our risk factors since our Annual Report on Form 10-K for the year ended June 30, 2019.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. MINE SAFETY DISCLOSURES
None
None
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(a) Exhibit index
(1) | The documents set forth below are filed herewith or incorporated herein by reference to the location indicated. |
EXHIBIT INDEX
Exhibit No. |
| Title |
| Method of Filing |
|
| Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on December 26, 2019 | ||
| ||||
|
| Filed herewith | ||
| ||||
|
| Furnished herewith | ||
| ||||
101 |
| The following materials from the Company’s Quarterly Report on Form 10-Q for the six months ended December 31, 2019 formatted in Extensible Business Reporting Language (XBRL): (i) the Condensed Consolidated Statements of Income, (ii) the Condensed Consolidated Statements of Comprehensive Income, (iii) the Condensed Consolidated Balance Sheets, (iv) the Condensed Consolidated Statements of Cash Flows, and (v) related notes |
| Filed herewith |
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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.
| INNOVATION PHARMACEUTICALS INC. | ||
| |||
Dated: February 13, 2020 | By: | /s/ Leo Ehrlich | |
| Name: | Leo Ehrlich | |
| Title: | Chief Executive Officer and Chief Financial Officer (Principal Executive, Accounting and Financial Officer) |
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