UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

☒     QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended: September 30, 2021

 

☐     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 

incorporation or organization)

 

(I.R.S. Empl.

Ident. No.)

 

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)

 

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 Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒     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 ☒     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

Smaller reporting company

 

 

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 ☒

 

The number of shares outstanding of each of the issuer’s classes of common equity, as of November 4, 2021 is as follows:

 

Class of Securities

 

Shares Outstanding

Common Stock Class A, $0.0001 par value

 

437,096,222

Common Stock Class B, $0.0001 par value

 

15,641,463

 

 

 

 

INNOVATION PHARMACEUTICALS INC.

FORM 10-Q

For the Three Months Ended September 30, 2021

 

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION

 

 

 

 

 

 

 

 

Item 1.

Financial Statements

 

4

 

 

Condensed Consolidated Balance Sheets as of September 30, 2021 and June 30, 2021 (unaudited)

 

4

 

 

Condensed Consolidated Statements of Operations for the three months ended September 30, 2021 and 2020 (unaudited)

 

5

 

 

Condensed Consolidated Statements of Stockholders’ Equity for the three months ended September 30, 2021 and 2020 (unaudited)

 

6

 

 

Condensed Consolidated Statements of Cash Flows for the three months ended September 30, 2021 and 2020 (unaudited)

 

7

 

 

Notes to Condensed Consolidated Financial Statements (unaudited)

 

8

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

26

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

36

 

Item 4.

Controls and Procedures

 

36

 

 

 

 

 

 

PART II – OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

37

 

Item 1A

Risk Factors

 

37

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

37

 

Item 3.

Defaults Upon Senior Securities

 

37

 

Item 4.

Mine Safety Disclosures

 

37

 

Item 5.

Other Information

 

37

 

Item 6.

Exhibits

 

38

 

 

 

 

 

 

SIGNATURES

 

39

 

 

 
2

 

 

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 such as, among others, COVID-19; 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; our ability 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.; the development of treatments or vaccines relating to the COVID-19 pandemic by other entities; 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

 

PART I. FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

INNOVATION PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

AS OF SEPTEMBER 30, 2021 AND JUNE 30, 2021

(Unaudited)

(Rounded to nearest thousand except for shares data)

 

 

 

September 30,

 

 

June 30,

 

 

 

2021

 

 

2021

 

ASSETS

 

Current Assets:

 

 

 

 

 

 

Cash

 

$ 11,206,000

 

 

$ 10,194,000

 

Prepaid expenses and other current assets

 

 

171,000

 

 

 

495,000

 

Total Current Assets

 

 

11,377,000

 

 

 

10,689,000

 

Other Assets:

 

 

 

 

 

 

 

 

Patent costs - net

 

 

2,676,000

 

 

 

2,754,000

 

Deferred offering costs

 

 

599,000

 

 

 

778,000

 

Security deposit

 

 

78,000

 

 

 

78,000

 

Total Other Assets

 

 

3,353,000

 

 

 

3,610,000

 

Total Assets

 

$ 14,730,000

 

 

$ 14,299,000

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable - (including related party payables of approx. $1,511,000 and $1,511,000, respectively)

 

$ 2,339,000

 

 

$ 2,563,000

 

Accrued expenses - (including related party accruals of approx. $27,000 and $8,000, respectively)

 

 

592,000

 

 

 

348,000

 

Accrued salaries and payroll taxes - (including related party accrued salaries of approx. $1,580,000 and $1,915,000, respectively)

 

 

1,654,000

 

 

 

1,992,000

 

Operating lease - current liability

 

 

172,000

 

 

 

165,000

 

Convertible note payable - related party

 

 

1,283,000

 

 

 

1,283,000

 

Accrued dividend - Series B 5% convertible preferred stock

 

 

15,000

 

 

 

15,000

 

Loan payable

 

 

172,000

 

 

 

172,000

 

Total Current Liabilities

 

 

6,227,000

 

 

 

6,538,000

 

Other Liabilities:

 

 

 

 

 

 

 

 

Operating lease - long term liability

 

 

206,000

 

 

 

252,000

 

Total Liabilities

 

 

6,433,000

 

 

 

6,790,000

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ Equity

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value, 10,000,000 designated shares, no shares issued and outstanding

 

 

-

 

 

 

-

 

Common Stock - Class A, $.0001 par value, 600,000,000 shares authorized, 445,612,278 shares and 426,673,198 shares issued as of September 30, 2021 and June 30, 2021, respectively, 437,096,222 shares and 418,157,142 shares outstanding as of September 30, 2021 and June 30, 2021, respectively.

 

 

44,000

 

 

 

42,000

 

Common Stock - Class B, (10 votes per share); $.0001 par value, 100,000,000 shares authorized, 18,000,000 share issued as of September 30, 2021 and June 30, 2021, and 15,641,463 shares outstanding as of September 30, 2021 and June 30, 2021

 

 

2,000

 

 

 

2,000

 

Additional paid-in capital

 

 

127,677,000

 

 

 

124,835,000

 

Accumulated deficit

 

 

(117,172,000 )

 

 

(115,116,000 )

Treasury Stock, at cost (10,874,593 shares as of September 30, 2021 and June 30, 2021)

 

 

(2,254,000 )

 

 

(2,254,000 )

Total Stockholders’ Equity

 

 

8,297,000

 

 

 

7,509,000

 

Total Liabilities and Stockholders’ Equity

 

$ 14,730,000

 

 

$ 14,299,000

 

 

 

 

 

 

 

 

 

 

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 ENDED SEPTEMBER 30, 2021 AND 2020

(Unaudited)

(Rounded to nearest thousand except for shares and per share data)

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

Revenues

 

$ -

 

 

$ -

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development expenses

 

 

1,591,000

 

 

 

524,000

 

General and administrative expenses

 

 

185,000

 

 

 

264,000

 

Officers’ payroll and payroll tax expenses

 

 

119,000

 

 

 

127,000

 

Professional fees

 

 

128,000

 

 

 

214,000

 

Total operating expenses

 

 

2,023,000

 

 

 

1,129,000

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(2,023,000 )

 

 

(1,129,000 )

 

 

 

 

 

 

 

 

 

Other expenses

 

 

 

 

 

 

 

 

Interest expense – debt

 

 

(33,000 )

 

 

(44,000 )

 

 

 

 

 

 

 

 

 

Total other expenses

 

 

(33,000 )

 

 

(44,000 )

 

 

 

 

 

 

 

 

 

Loss before provision for income taxes

 

 

(2,056,000 )

 

 

(1,173,000 )

Provision for income taxes

 

 

-

 

 

 

-

 

Net loss

 

$ (2,056,000 )

 

$ (1,173,000 )

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$ (0.00 )

 

$ (0.00 )

 

 

 

 

 

 

 

 

 

Basic and Diluted Weighted Average Common Shares Outstanding

 

 

452,737,685

 

 

 

337,494,640

 

 

 

 

 

 

 

 

 

 

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’ EQUITY

FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020

(Unaudited)

(Rounded to nearest thousand, except for shares data)

 

For the Three Months Ended September 30, 2020

 

 

 

Common Stock A

 

 

Common Stock B

 

 

 

 

 

 

Treasury Stock

 

 

 

 

 

Shares

 

 

Par Value

$0.0001

 

 

Shares

 

 

Par Value

$0.0001

 

 

Additional

Paid-in

Capital

 

 

Accumulated

Deficit

 

 

Shares

 

 

Amount

 

 

Total

 

Balance at June 30, 2020

 

 

329,170,544

 

 

$ 33,000

 

 

 

1,818,180

 

 

$ -

 

 

$ 102,819,000

 

 

$ (101,244,000 )

 

 

659,448

 

 

$ (146,000 )

 

$ 1,462,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares sold to Aspire Capital under 2020 Agreement at $0.20 - $0.22 range

 

 

13,500,000

 

 

 

1,000

 

 

 

 

 

 

 

 

 

2,850,000

 

 

 

 

 

 

 

 

 

 

 

 

2,851,000

 

Shares issued as commitment fee, 7/31/2020 at $0.23, net

 

 

6,250,000

 

 

 

1,000

 

 

 

 

 

 

 

 

 

1,317,000

 

 

 

 

 

 

 

 

 

 

 

 

1,318,000

 

Restricted stock awards issued to employee for services at $0.132 to $0.398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,000

 

 

 

 

 

 

 

 

 

 

 

 

5,000

 

Stock options issued to employee for services at $0.132 to $0.398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14,000

 

 

 

 

 

 

 

 

 

 

 

 

14,000

 

Stock options issued to consultants for services at $0.14 to $0.32

 

 

 

 

 

 

 

 

 

 

 

 

 

 

43,000

 

 

 

 

 

 

 

 

 

 

 

 

43,000

 

Purchase of 2,200,000 shares of Common Stock Class B to Officer & 412,238 shares were withheld for tax purposes as Treasury shares

 

 

 

 

 

 

 

 

2,200,000

 

 

 

 

 

 

242,000

 

 

 

 

 

 

 

 

 

 

 

 

242,000

 

Issuance of shares for tax purposes as Treasury Shares

 

 

 

 

 

 

 

 

(412,238 )

 

 

 

 

 

 

 

 

 

 

 

412,238

 

 

 

(90,000 )

 

 

(90,000 )

Issuance of 58,394 shares to employee & 21,606 shares were withheld for tax purposes as Treasury shares

 

 

58,394

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of shares for tax purposes as Treasury Shares

 

 

(21,606 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

21,606

 

 

 

(3,000 )

 

 

(3,000 )

Net loss for the three months ended 9/30/2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,173,000 )

 

 

 

 

 

 

 

 

(1,173,000 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2020

 

 

348,957,332

 

 

$ 35,000

 

 

 

3,605,942

 

 

$

 

 

$ 107,290,000

 

 

$ (102,417,000 )

 

 

1,093,292

 

 

$ (239,000 )

 

$ 4,669,000

 

 

For the Three Months Ended September 30, 2021

 

 

 

Common Stock A

 

 

Common Stock B

 

 

 

 

 

 

Treasury Stock

 

 

 

 

 

Shares

 

 

Par Value

$0.0001

 

 

Shares

 

 

Par Value

$0.0001

 

 

Additional

Paid-in

Capital

 

 

Accumulated

Deficit

 

 

Shares

 

 

Amount

 

 

Total

 

Balance at June 30, 2021

 

 

418,157,142

 

 

$ 42,000

 

 

 

15,641,463

 

 

$ 2,000

 

 

$ 124,835,000

 

 

$ (115,116,000 )

 

 

10,874,593

 

 

$ (2,254,000 )

 

$ 7,509,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Offering cost

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(179,000 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(179,000 )

Restricted stock awards of common stock issued to employee for services at $0.132 to $0.398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,000

 

 

 

 

 

 

 

 

 

 

 

 

3,000

 

Stock options issued to employee for services at $0.132 to $0.398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,000

 

 

 

 

 

 

 

 

 

 

 

 

8,000

 

Stock options issued to consultants for services at $0.14 to $0.384

 

 

 

 

 

 

 

 

 

 

 

 

 

 

29,000

 

 

 

 

 

 

 

 

 

 

 

 

29,000

 

Conversion of 3,036 shares of preferred stock into 18,939,080 shares of common stock

 

 

18,939,080

 

 

 

2,000

 

 

 

 

 

 

 

 

 

2,981,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,983,000

 

Net loss for the three months ended 9/30/2021 - unaudited

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,056,000 )

 

 

 

 

 

 

 

 

(2,056,000 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2021

 

 

437,096,222

 

 

$ 44,000

 

 

 

15,641,463

 

 

$ 2,000

 

 

$ 127,677,000

 

 

$ (117,172,000 )

 

 

10,874,593

 

 

$ (2,254,000 )

 

$ 8,297,000

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 
6

Table of Contents

 

INNOVATION PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020

(Unaudited)

(Rounded to nearest thousand, except for shares data)

 

 

 

2021

 

 

2020

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

Net loss

 

$ (2,056,000 )

 

$ (1,173,000 )

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Stock based compensation

 

 

40,000

 

 

 

62,000

 

Amortization of patent costs

 

 

95,000

 

 

 

94,000

 

 

 

 

 

 

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and security deposits

 

 

324,000

 

 

 

18,000

 

Accounts payable

 

 

(224,000 )

 

 

122,000

 

Accrued expenses

 

 

244,000

 

 

 

30,000

 

Accrued officers’ salaries and payroll taxes

 

 

(338,000 )

 

 

(642,000 )

Operating lease liability

 

 

(39,000 )

 

 

(32,000 )

Net cash used in operating activities

 

 

(1,954,000 )

 

 

(1,521,000 )

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

Patent costs

 

 

(17,000 )

 

 

(3,000 )

Net cash used in investing activities

 

 

(17,000 )

 

 

(3,000 )

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Sale of common stock, net of offering costs

 

 

-

 

 

 

2,851,000

 

Proceeds from exercise of warrants to purchase Series B-2 5% convertible preferred stock

 

 

2,983,000

 

 

 

-

 

Purchase of treasury stock

 

 

-

 

 

 

(93,000 )

Net cash provided by financing activities

 

 

2,983,000

 

 

 

2,758,000

 

 

 

 

 

 

 

 

 

 

NET DECREASE IN CASH

 

 

1,012,000

 

 

 

1,234,000

 

CASH, BEGINNING OF PERIOD

 

 

10,194,000

 

 

 

6,018,000

 

CASH, END OF PERIOD

 

$ 11,206,000

 

 

$ 7,252,000

 

 

 

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION

 

 

 

 

 

 

 

 

Cash paid for interest

 

$ 15,000

 

 

$ 15,000

 

Cash paid for tax

 

$ -

 

 

$ -

 

SUPPLEMENTAL DISCLOSURE OF NON-CASH FLOW INVESTING AND FINANCING ACTIVITIES

 

 

 

 

 

 

 

 

Shares issued as deferred offering costs

 

$ -

 

 

 

1,438,000

 

Cancellation of shareholder debt for the purchase of 2.2M shares of Common Stock Class B shares

 

 

-

 

 

 

242,000

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 
7

Table of Contents

 

INNOVATION PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2021

(Unaudited)

 

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, 2021, included in our Annual Report on Form 10-K for the year ended June 30, 2021.

 

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 periods have been made. Results for the interim periods 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,” “Innovation,” “we,” “us” or “our” mean Innovation Pharmaceuticals Inc.

 

Basis of Presentation

 

Innovation Pharmaceuticals Inc. 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 is intended to 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 condensed consolidated financial statements include the accounts of Innovation Pharmaceuticals Inc., 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. There was no translation gain and loss for the three months ended September 30, 2021 and 2020.

 

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.

 

In December 2020, the U.S. Food and Drug Administrations (FDA) approved the Company’s Investigational New Drug (IND) application to proceed with initiation of a randomized, placebo-controlled Phase 2 clinical trial of Brilacidin in moderate-to-severe hospitalized patients with COVID-19. Similar regulatory approval was obtained from the Russian Ministry of Health. The clinical trial is in progress.

 

We currently own all development and marketing rights to our products, other than the license rights granted to Alfasigma S.p.A. in July 2019 for the development, manufacturing and commercialization of locally-administered Brilacidin for ulcerative proctitis/ulcerative proctosigmoiditis (“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.

 

 
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2. Liquidity

 

As of September 30, 2021, the Company’s cash amounted to $11.2 million and current liabilities amounted to $6.2 million. The Company has expended substantial funds on its clinical trials and expects to continue our spending on research and development expenditures. Our net losses incurred for the three months ended September 30, 2021 and 2020, amounted to $2.1 million and $1.2 million, respectively, and we had working capital of approximately $5.2 million and $4.2 million at September 30, 2021 and June 30, 2021, respectively.

 

On July 31, 2020, the Company entered into a new common stock purchase agreement (the “2020 Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”) which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $30.0 million of the Company’s common stock over the 24-month term of the 2020 Agreement. In consideration for entering into the 2020 Agreement, the Company issued to Aspire Capital 6,250,000 shares of its Class A Common Stock as a commitment fee. The commitment fee of approximately $1.4 million was recorded as deferred financing costs and additional paid-in capital and this asset will be amortized over the life of the 2020 Agreement. As of September 30, 2021, the available balance was $25.4 million.

 

We anticipate that future budget expenditures will be approximately $10.7 million for the next 12 months, including approximately $8.7 million for clinical activities, supportive research, and drug product. Alternatively, if we decide to pursue a more aggressive plan with our clinical trials, we will require additional sources of capital during the fiscal year 2022 to meet our working capital requirements for our planned clinical trials. Potential sources for capital include grant funding for COVID-19 research and equity financings. There can be no assurances that we will be successful in receiving any grant funding for our programs.

 

Management believes that the amounts available from Aspire Capital and under the Company’s effective shelf registration statement will be sufficient to fund the Company’s operations for the next 12 months.

 

If we are unable to generate enough working capital from our current or future financing agreements with Aspire Capital when needed or secure additional sources of funding, it may be necessary to significantly reduce our current rate of spending through reductions in staff and delaying, scaling back or stopping certain research and development programs, including more costly Phase 2 and Phase 3 clinical trials on our wholly-owned development programs as these programs progress into later stage development. Insufficient liquidity may also require us to relinquish greater rights to product candidates at an earlier stage of development or on less favorable terms to us and our stockholders than we would otherwise choose in order to obtain up-front license fees needed to fund operations. These events could prevent us from successfully executing our operating plan.

 

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.

 

 
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Basic Loss per Share

 

Basic and diluted loss per share are computed based on the weighted-average common shares and common share equivalents outstanding during the period. Except with respect to certain voting, conversion and transfer rights and as otherwise expressly provided in the Company’s Articles of Incorporation or required by applicable law, shares of the Company’s Class A common stock and Class B common stock have the same rights and privileges and rank equally, share ratably and are identical in all respects as to all matters. Accordingly, basic and diluted net income (loss) per share are the same for both classes. Common share equivalents consist of stock options, restricted stock, warrants and convertible related party notes payable. Common share equivalents were excluded from the computation of diluted earnings per share for the three months ended September 30, 2021 and 2020, because their effect was anti-dilutive.

 

Weighted average shares of common stock outstanding used in the calculation of basic and diluted earnings per share were as follows:

 

 

 

September 30,

 

 

 

2021

 

 

2020

 

Net loss per share, basic and diluted

 

 

(0.00 )

 

 

(0.00 )

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

Class A common stock

 

 

437,096,222

 

 

 

337,494,640

 

Class B common stock

 

 

15,641,463

 

 

 

2,245,688

 

Total weighted average shares outstanding

 

 

452,737,685

 

 

 

339,740,328

 

 

 

 

 

 

 

 

 

 

Antidilutive securities not included:

 

 

 

 

 

 

 

 

Stock options

 

 

7,074,935

 

 

 

20,876,085

 

Stock options arising from convertible note payable and accrued interest

 

 

2,603,618

 

 

 

3,241,682

 

Restricted stock grants

 

 

58,392

 

 

 

116,787

 

Total

 

 

9,736,945

 

 

 

24,234,554

 

 

Treasury Stock

 

The Company accounts for treasury stock using the cost method. There were 8,516,056 shares of Class A common stock and 2,358,537 shares of Class B common stock held in treasury, purchased at a total cumulative cost of approximately $2.3 million as of September 30, 2021 and June 30, 2021. There were 659,448 shares of Class A common stock held in treasury, purchased at a total cumulative cost of $146,000 as of September 30, 2021 and June 30, 2021 (see Note 14. Equity Transactions).

 

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.

 

Revenue Recognition

 

The Company follows the guidance of accounting standard ASC 606 (Topic 606), Revenue from Contracts with Customers, and all the related amendments.

 

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 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).

 

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.

 

 
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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.

 

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.

 

 
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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, non-employees and directors in connection with its stock option plan is based on 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.”

 

Awards with service-based vesting conditions only – Expense recognized on a straight-line basis over the requisite service period of the award.

 

Awards with performance-based vesting conditions – Expense is not recognized until it is determined that it is probable the performance-based conditions will be met. When achievement of a performance-based condition is probable, a catch-up of expense will be recorded as if the award had been vesting on a straight-line basis from the award date. The award will continue to be expensed on a straight-line basis over the requisite service period basis until a higher performance-based condition is met, if applicable.

 

Awards with market-based vesting conditions – Expense recognized on a straight-line basis over the requisite service period, which is the lesser of the derived service period or the explicit service period if one is present. However, if the market condition is satisfied prior to the end of the requisite service period, the Company will accelerate all remaining expense to be recognized.

 

Awards with both performance-based and market-based vesting conditions – if an award vesting or exercisability is conditional upon the achievement of either a market condition or performance or service conditions, the requisite service period is generally the shortest of the explicit, implicit, and derived service period.

 

We have elected to use the Black-Scholes-Merton pricing model to determine the fair value of stock options on the dates of grant. Restricted stock units are measured based on the fair market values of the underlying stock on the dates of grant. We recognize stock-based compensation using the straight-line method.

 

 
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4. Patents, net

 

Patents, net consisted of the following (rounded to nearest thousand):

 

 

 

Useful life

(years)

 

 

September 30,

2021

 

 

June 30,

2021

 

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

 

 

 

1,297,000

 

 

 

1,280,000

 

 

 

 

 

 

 

 

5,523,000

 

 

 

5,506,000

 

Less: Accumulated amortization for Brilacidin, Anti-microbial- surfactants and related compounds

 

 

 

 

 

 

(2,448,000 )

 

 

(2,373,000 )

Accumulated amortization for Patents-Kevetrin and related compounds

 

 

 

 

 

 

(399,000 )

 

 

(379,000 )

Total

 

 

 

 

 

$ 2,676,000

 

 

$ 2,754,000

 

 

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.

 

Amortization expense for the three months ended September 30, 2021 and 2020 was approximately $95,000 and $94,000, respectively.

 

At September 30, 2021, the future amortization period for all patents was approximately 4.12 years to 16.75 years. Future estimated amortization expenses are approximately $285,000 for the year ending June 30, 2022, $380,000 for each year from 2023 to 2025, $370,000 for the year ending June 30, 2026 and a total of $881,000 for the year ending June 30, 2027 and thereafter.

 

5. Accrued Expenses – Related Parties and Other

 

Accrued expenses consisted of the following (rounded to nearest thousand):

 

 

 

September 30,

2021

 

 

June 30,

2021

 

 

 

 

 

 

 

 

Accrued research and development consulting fees

 

$ 565,000

 

 

$ 340,000

 

Accrued rent (Note 10) - related parties

 

 

8,000

 

 

 

8,000

 

Accrued interest (Note 11) - related parties

 

 

19,000

 

 

 

-

 

 

 

 

 

 

 

 

 

 

Total

 

$ 592,000

 

 

$ 348,000

 

 

6. Accrued Salaries and Payroll Taxes - Related Parties and Other

 

Accrued salaries and payroll taxes consisted of the following (rounded to nearest thousand):

 

 

 

September 30,

2021

 

 

June 30,

2021

 

 

 

 

 

 

 

 

Accrued salaries - related parties

 

$ 1,455,000

 

 

$ 1,785,000

 

Accrued payroll taxes - related parties

 

 

125,000

 

 

 

130,000

 

Withholding tax - payroll

 

 

74,000

 

 

 

77,000

 

 

 

 

 

 

 

 

 

 

Total

 

$ 1,654,000

 

 

$ 1,992,000

 

 

 
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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 UP/UPS.

 

Under the terms of the License Agreement, Alfasigma made an initial upfront non-refundable payment of $0.4 million to the Company in July, 2019 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 3 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. At this time, Alfasigma has completed a Phase 1 clinical trial with Brilacidin. 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.

 

The Company generated revenue of $0 million and $0 million for the three months ended September 30, 2021 and 2020, respectively.

 

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 was fully impaired on December 31, 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 December 31, 2019. The Company vacated the leased office space in December 2019, and in January 2020 the Company initiated a lawsuit against the lessor relating to an automatic extension of the lease for the office space and related matters (See Note 9. Commitments and Contingencies).

 

The components of lease expense and supplemental cash flow information related to leases for the year are as follows:

 

 

 

Three Months

Ended

September 30,

2021

 

Lease Cost

 

 

 

Operating lease cost (included in general and administrative in the Company’s condensed consolidated statement of operations)

 

$ 17,000

 

Variable lease cost

 

 

3,000

 

 

 

$ 20,000

 

Other Information

 

 

 

 

Cash paid for amounts included in the measurement of lease liabilities for the three months ended September 30, 2021

 

$ 59,000

 

Weighted average remaining lease term – operating leases (in years)

 

 

3.00

 

Average discount rate – operating leases

 

 

18 %

 

 
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The supplemental balance sheet information related to leases for the period is as follows:

 

 

 

At

September 30,

2021

 

Operating leases

 

 

 

Short-term operating lease liabilities

 

$ 172,000

 

Long-term operating lease liabilities

 

 

206,000

 

 

 

 

 

 

Total operating lease liabilities

 

$ 378,000

 

 

The following table provides maturities of the Company’s lease liabilities at September 30, 2021 as follows:

 

 

 

Operating

Leases

 

Fiscal Year Ending June 30,

 

 

 

 

 

 

 

2022

 

 

167,000

 

2023

 

 

223,000

 

2024 (remaining 3 months)

 

 

60,000

 

Total lease payments

 

 

450,000

 

Less: Imputed interest/present value discount

 

 

(72,000 )

 

 

 

 

 

Present value of lease liabilities

 

$ 378,000

 

 

Operating lease cost for the three months ended September 30, 2021 and September 30, 2020 was approximately $20,000 and $27,000, respectively.

 

9. Commitments and Contingencies

 

Litigation

 

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. The Company is currently unable to determine the probability of the outcome or reasonably estimate the loss or gain, if any.

 

Contractual Commitments

 

The Company has total non-cancellable contractual minimum commitments of approximately $3.3 million to contract research organizations as of September 30, 2021. Expenses are recognized when services are performed by the contract research organizations.

 

 
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Contingent Liability - Disputed Invoices

 

As described in Note 6. Accrued Salaries and Payroll Taxes, the Company 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. Related Party Transactions, the Company has a payable to Kard Scientific, Inc. (“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. Menon. 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. 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 September 30, 2021.

 

10. Related Party Transactions

 

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 September 30, 2021 and June 30, 2021, 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.

 

Share Issuance

 

On February 23, 2020, the Company issued (i) options for the purchase of 500,000 shares of Class A common stock at an exercise price of $0.10 per share, which is 110% of the previous per share closing price of $0.09 on February 21, 2020, and (ii) 500,000 shares of Class A common stock to each member of the Company’s Board of Directors, consisting of Leo Ehrlich, Barry Schechter and Zorik Spektor.

 

Other related party transactions are disclosed in Note 11. Convertible Note Payable - Related Party below.

 

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 December 29, 2010, the Company issued 180,000,000 Equity Incentive Options to Mr. Ehrlich, which are exercisable at $0.11 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 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).

 

On March 30, 2020, the Company issued 909,090 shares of Class B common stock at the option exercise price of $0.11 per share to Mr. Ehrlich 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).

 

 
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On September 8, 2020, the Company issued 1,787,762 shares of Class B common shares (net of 412,238 shares of Class B common shares withheld to satisfy taxes) at the option exercise price of $0.11 per share to Mr. Ehrlich for his partial exercise of his option, paid by the cancellation of debt to Mr. Ehrlich of $242,000 to satisfy the exercise price (as permitted pursuant to the terms of the option agreement).

 

As of September 30, 2021 and June 30, 2021, the principal balance of this convertible note payable to Mr. Ehrlich, the Company’s Chairman and CEO was approximately $1,283,000.

 

As of September 30, 2021 and June 30, 2021, the balance of accrued interest payable was $18,000 and $0, respectively (see Note 5. Accrued Expenses – Related Parties and Other).

 

As of September 30, 2021 and June 30, 2021, the total outstanding balances of principal and interest were approximately $1,301,000 and $1,283,000, respectively.

 

12. Loan payable

 

On May 10, 2020 and April 19, 2021, the Company received loan proceeds in the amount of approximately $93,000 and $79,000, respectively, under the Paycheck Protection Program (“PPP”) and it was recorded under loan payable. The PPP, established as part of the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), provides for loans to qualifying businesses for amounts up to 2.5 times of the average monthly payroll expenses of the qualifying business. The loans and accrued interest are forgivable after eight weeks as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels. The amount of loan forgiveness will be reduced if the borrower terminates employees or reduces salaries during the eight-week period.

 

The Company applied for the forgiveness of the first loan and such application is in process. The Company intends to apply for the forgiveness of the second PPP loan during fiscal 2022.

 

13. Equity Incentive Plans, Stock-Based Compensation, Exercise of Options and Warrants Outstanding

 

Stock-based Compensation – Stock Options

 

2016 Equity Incentive Plan (the “2016 Plan”)

 

On June 30, 2016, the Board of Directors adopted the Company’s 2016 Plan. The 2016 Plan became effective upon adoption by the Board of Directors on June 30, 2016.

 

On February 23, 2020, the Board of Directors approved an amendment to Section 4.1 of the 2016 Plan to increase the annual limit on the number of awards under such Plan to outside directors from 250,000 to 1,500,000.

 

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). 

 

Stock Options

 

The fair value of options granted for the three months ended September 30, 2021 and 2020 was estimated on the date of grant using the Black-Scholes-Merton Model that uses assumptions noted in the following table.

 

 

 

Three months ended

September 30,

 

 

 

2021

 

 

2020

 

Expected term (in years)

 

 

5

 

 

 

10

 

Expected stock price volatility

 

 

89.51 %

 

93.95 to 95.47

%

Risk-free interest rate

 

0.69% to 0.89

%

 

0.59 to 0.68

%

Expected dividend yield

 

 

0

 

 

 

0

 

 

 
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The components of stock-based compensation expense included in the Company’s Statement of Operations for the three months ended September 30, 2021 and 2020 are as follows (rounded to nearest thousand):

 

 

 

Three months ended

September 30,

 

Stock-based compensation

 

2021

 

 

2020

 

Stock-based compensation – employees

 

$ 11,000

 

 

$ 19,000

 

Stock-based compensation – consultants

 

 

29,000

 

 

 

43,000

 

– included in Research and Development expenses

 

$ 40,000

 

 

$ 62,000

 

 

During the three months ended September 30, 2021 and 2020

 

On July 30, 2020, the Company agreed to issue 100,000 stock options to purchase shares of the Company’s common stock to one consultant for his one-year contract. These options were issued with an exercise price of $0.27 per share and vest 33 1/3% on July 30, 2021, 33 1/3% on January 30, 2022, and 33 1/3% on July 30, 2022. The value of these options was approximately $19,000. During the three months ended September 30, 2021, the Company recorded approximately $8,000 of related stock-based compensation. The assumptions we used in the Black Scholes option-pricing model were disclosed above.

 

On July 1, 2021, the Company agreed to issue 225,000 stock options to purchase shares of the Company’s common stock to one consultant for his one-year contract. These options were issued with an exercise price of $0.21 per share and vest 33 1/3% on July 1, 2021, 33 1/3% on January 1, 2022, and 33 1/3% on July 1, 2022. The value of these options was approximately $33,000. During the three months ended September 30, 2021, the Company recorded approximately $16,000 of related stock-based compensation. The assumptions we used in the Black Scholes option-pricing model were disclosed above.

 

On February 10, 2021, the Company agreed to issue 75,000 stock options to purchase shares of the Company’s common stock to one consultant for his one-year contract. These options were issued with an exercise price of $0.38 per share and vest 33 1/3% on February 10, 2021, 33 1/3% on July 1, 2021, and 33 1/3% on January 1, 2022. The value of these options was approximately $20,000. During the three months ended September 30, 2021 and 2020, the Company recorded approximately $4,000 and $0 of related stock-based compensation, respectively. The assumptions we used in the Black Scholes option-pricing model were disclosed above.

 

On September 11, 2020, 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. The Company also issued 172,987 options to purchase common stock. These stock options with 3 years vesting period were valued at approximately $33,000 and these 58,394 shares of the Company’s common stock were valued at approximately $13,000, based on the closing bid price as quoted on the OTC on September 11, 2020 at $0.22 per share. During the three months ended September 30, 2021, the Company recorded approximately $4,000 of stock-based compensation expense in connection with the foregoing equity awards, including approximately $3,000 of stock option expense and $1,000 of stock awards. During the three months ended September 30, 2020, the Company recorded approximately $1,000 of stock-based compensation expense in connection with the foregoing equity awards, including approximately $500 of stock option expense and $500 of stock awards.

 

On July 23, 2020, the Company agreed to issue 100,000 stock options to purchase shares of the Company’s common stock to one consultant for his one-year contract. These options were issued with an exercise price of $0.32 per share and vest 33 1/3% on July 23, 2020, 33 1/3% on January 23, 2021, and 33 1/3% on July 23, 2021. The value of these options was approximately $28,000. During the three months ended September 30, 2021 and 2020, the Company recorded approximately $1,000 and $13,000 of related stock-based compensation, respectively. The assumptions we used in the Black Scholes option-pricing model were disclosed above.

 

On May 18, 2020, the Company agreed to issue 500,000 stock options to purchase shares of the Company’s common stock each to two consultants for their one-year contracts. These options were issued with an exercise price of $0.14 per share and vest 33 1/3% on July 1, 2020, 33 1/3% on January 1, 2021, and 33 1/3% on July 1, 2021. The value of these options was approximately $78,000. During the three months ended September 30, 2021 and 2020, the Company recorded approximately $0 and $13,000 of related stock-based compensation, respectively. The assumptions we used in the Black Scholes option-pricing model were disclosed above.

 

 
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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. The Company also issued 172,987 options to purchase common stock. These stock options with 3 years vesting period were 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. During the three months ended September 30, 2021, 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. During the three months ended September 30, 2020, 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 also issued to Ms. Harness 58,394 shares of the Company’s common stock. 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. During the three months ended September 30, 2021, the Company recorded approximately $5,000 of stock-based compensation expense in connection with the foregoing equity awards, including approximately $4,000 of stock option expense and $1,000 of stock awards. During the three months ended September 30, 2020, the Company recorded approximately $7,000 of stock-based compensation expense in connection with the foregoing equity awards, including approximately $5,000 of stock option expense and $2,000 of stock awards.

 

Exercise of options

 

There was no exercise of options to purchase Class B common stock during the three months ended September 30, 2021. The details of exercises of options to purchase Class B common stock during the three months ended September 30, 2020 are disclosed in Note 14. Equity Transactions.

 

Forfeiture of options

 

There was forfeiture of 30,000 options and 294,330 options to purchase Class A common stock during the three months ended September 30, 2021 and the year ended June 30, 2021 relating to the expiry of options of 12 consultants.

 

Stock Options Issued and Outstanding

 

The following table summarizes all stock option activity under the Company’s equity incentive plans:

 

 

 

Number of
Options

 

 

Weighted Average
Exercise Price

 

 

Weighted

Average
Remaining

Contractual Life

(Years)

 

 

Aggregate

Intrinsic Value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Outstanding at June 30, 2020

 

 

22,803,098

 

 

$ 0.18

 

 

 

1.83

 

 

$ 5,857,312

 

Granted

 

 

452,987

 

 

$ 0.27

 

 

 

6.96

 

 

 

 

Exercised

 

 

(16,181,820 )

 

$ 0.11

 

 

 

 

 

 

 

Forfeited/expired

 

 

(294,330 )

 

$ 0.55

 

 

 

 

 

 

 

Outstanding at June 30, 2021

 

 

6,779,935

 

 

$ 0.35

 

 

 

4.45

 

 

$ 345,923

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Granted

 

 

325,000

 

 

$ 0.23

 

 

 

4.77

 

 

 

 

Exercised

 

 

 

 

$

 

 

 

 

 

 

 

Forfeited/expired

 

 

(30,000 )

 

$ 0.50

 

 

 

 

 

 

 

Outstanding at September 30, 2021

 

 

7,074,935

 

 

$ 0.34

 

 

 

4.24

 

 

$ 462,952

 

Exercisable at September 30, 2021

 

 

6,660,282

 

 

$ 0.35

 

 

 

4.11

 

 

$ 446,688

 

Unvested stock options at September 30, 2021

 

 

414,653

 

 

$ 0.22

 

 

 

6.35

 

 

$ 16,264

 

 

 
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Table of Contents

 

Restricted Stock Awards Outstanding

 

The following summarizes our restricted stock activity:

 

 

 

 

 

Weighted

 

 

 

 

 

Average

 

 

 

Number of

 

 

Grant Date

 

 

 

Shares

 

 

Fair Value

 

Total unvested shares outstanding at June 30, 2020

 

 

116,787

 

 

$ 0.32

 

 

 

 

 

 

 

 

 

 

Total shares granted

 

 

58,394

 

 

$ 0.22

 

Total shares vested

 

 

(58,395 )

 

$ 0.41

 

Total shares forfeited

 

 

 

 

$

 

Total unvested shares outstanding at June 30, 2021

 

 

116,786

 

 

$ 0.22

 

 

 

 

 

 

 

 

 

 

Total shares granted

 

 

-

 

 

$ -

 

Total shares vested

 

 

(58,394 )

 

$ 0.25

 

Total shares forfeited

 

 

-

 

 

$ -

 

Total unvested shares outstanding at September 30, 2021

 

 

58,392

 

 

$ 0.19

 

 

Scheduled vesting for outstanding restricted stock awards at September 30, 2021 is as follows:

 

 

 

Year Ending June 30,

 

 

 

2023

 

 

2024

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

Scheduled vesting

 

 

38,928

 

 

 

19,464

 

 

 

58,392

 

 

As of September 30, 2021, there was approximately $11,000 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 $7,000 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 1.72years.

 

14. Equity Transactions

 

$30 million Class A Common Stock Purchase Agreement with Aspire Capital

 

On July 31, 2020, the Company entered into the 2020 Agreement with Aspire Capital which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $30.0 million of the Company’s common stock over the 24-month term of the Agreement. In consideration for entering into the 2020 Agreement, the Company issued to Aspire Capital 6,250,000 shares of its Class A Common Stock as a commitment fee. The commitment fee of approximately $1.4 million was recorded as deferred financing costs and additional paid-in capital and this asset will be amortized over the life of the 2020 Agreement. The amortized amount of approximately $0.2 million was recorded to additional paid-in capital for the three months ended September, 2021 and 2020. The unamortized portion is carried on the balance sheet as deferred offering costs and was approximately $0.5 million and $0.7 million at September 30, 2021 and June 30, 2021.

 

During the quarter ended September 30, 2020, the Company generated proceeds of approximately $2.9 million under the 2020 Agreement with Aspire Capital from the sale of approximately 13.5 million shares of its common stock. During the quarter ended September 30, 2021, there was no sale of common stock. As of September 30, 2021, the available balance under the 2020 Agreement was approximately $25.4 million.

 

 
20

Table of Contents

 

Class B Common Stock

 

On September 8, 2020, Mr. Ehrlich exercised 2.2 million options to purchase 2.2 million shares of Class B common stock at the option exercise price of $0.11 per share. Mr. Ehrlich paid for this exercise of his option by the cancellation of debt to Mr. Ehrlich of $242,000 to satisfy the exercise price (See Note 11. Convertible Note Payable). The Company issued 1,787,762 shares of Class B common stock (net share issuance amount), to Mr. Ehrlich. The remaining 412,238 shares of Class B common stock were withheld from Mr. Ehrlich for the payment of payroll taxes.

 

On October 2, 2020, Mr. Ehrlich exercised 909,090 options to purchase 909,090 shares of Class B common stock at the option exercise price of $0.11 per share. Mr. Ehrlich paid for this exercise of his option by the cancellation of debt to Mr. Ehrlich of $100,000 to satisfy the exercise price (See Note 11. Convertible Note Payable to the condensed consolidated financial statements). The Company issued 727,994 shares of Class B common stock (net share issuance amount), to Mr. Ehrlich. The remaining 181,096 shares of Class B common stock were withheld from Mr. Ehrlich for the payment of payroll taxes.

 

On December 28, 2020, Mr. Ehrlich exercised his option to purchase 13,072,730 shares of Class B common stock, at the option exercise price at $0.11 per shares for the shares, paid by the cancellation of 6,980,583 shares of Class A common stock held by Mr. Ehrlich of $1,438,000 to satisfy the exercise price. The total taxable compensation to Mr. Ehrlich for the 13,072,730 shares was approximately $540,000, based upon the closing stock price on December 29, 2020 of $0.21 a share. The Company withheld 1,765,203 shares of Class B common stock and cancelled additional 854,419 shares of Class A common stock held by Mr. Ehrlich. As a result, the Company issued 11,307,527 shares of Class B common shares (net of 1,765,203 shares of Class B common shares withheld to satisfy taxes), and cancelled 7,835,002 shares of Class A common stock held by Mr. Ehrlich. These shares withheld are being reported by the Company as treasury stock, at cost, on the Company’s accompanying balance sheets.

 

As of September 30, 2021 and June 30, 2021, the total issued number of Class B common stock were 18 million shares and the total outstanding number of Class B common stock were 15,641,463.

 

Series B-2 5% convertible preferred stock (“2020 Series B-2 5% convertible preferred stock”)

 

On December 4, 2020, the Company entered into a securities purchase agreement (the “Series B-2 Securities Purchase Agreement”) with KIPS Bay Select LP for the sale of an aggregate of 5,089 shares of the Company’s Series B-2 5% convertible preferred stock (the “Series B-2 preferred stock”), for aggregate gross proceeds of approximately $5.0 million. An initial closing for the sale of 3,053 shares of the Series B-2 preferred stock closed on December 9, 2020 for aggregate gross proceeds of approximately $3.0 million, and a second closing for the sale of 2,036 shares of the Series B-2 preferred stock closed on February 8, 2021 for aggregate gross proceeds of approximately $2.0 million. Under the Series B-2 Securities Purchase Agreement, the Company also issued to the investors warrants to purchase up to an additional 10,178 shares of preferred stock.

 

The Series B-2 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-2 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 (See ASC 480-10-35-5).

 

The warrants issued in connection with the Series B-2 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-2 preferred stock fair value (without the warrants)) with an offsetting discount to the Series B-2 preferred stock. Given that the Series B-2 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-2 preferred stock liability after the issuance).

 

 
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Table of Contents

 

The Company recorded the December 9, 2020 issuance of 3,053 shares Series B-2 Preferred Stock at approximately $2.1 million and the underlying Series 1 and Series 2 warrants at approximately $0.9 million in total by allocating the gross proceeds to Series B-2 preferred stock (without the warrants) and warrants based on their relative fair values or direct valuation as appropriate. The Company recorded BCF of approximately $1.8 million associated with the issuance of the 3,053 shares of Series B-2 preferred stock to additional paid-in capital. The Company then recorded interest of approximately $2.7 million for the BCF and warrant discounts as a first day interest given that the Series B-2 preferred shares can be converted at any time to common stock and given no set term.

 

The Company recorded the February 8, 2021 issuance of 2,036 shares Series B-2 Preferred Stock at approximately $1.5 million and the underlying Series 1 and Series 2 warrants at approximately $0.5 million in total by allocating the gross proceeds to Series B-2 preferred stock (without the warrants) and warrants based on their relative fair values or direct valuation as appropriate. The Company recorded BCF of approximately $1.5 million associated with the issuance of the 2,036 shares of Series B-2 preferred stock to additional paid-in capital. The Company then recorded interest of approximately $2.0 million for the BCF and warrant discounts as a first day interest given that the Series B-2 preferred shares can be converted at any time to common stock and given no set term.

 

The issuance costs associated with the Series B-2 preferred stock transaction were attributed to the Series B-2 preferred stock (without the warrants) and to the Series 1 and Series 2 warrants based on their relative fair values. The issuance costs attributed to the warrants of approximately $10,000 were reflected as a reduction to additional paid-in capital. The issuances costs associated with the Series B-2 preferred stock liability of $25,000 was recorded immediately as an element of interest cost, which are reflected in interest expense - preferred stock. The change in fair value of the total Series B-2 preferred stock was $0 during the year ended June 30, 2021.

 

Underlying Series B-2 preferred stock dividends, paid quarterly, was accrued as interest (given the liability classification of the Series B-2 preferred stock) on a daily basis given fixed dividend terms under the Series B-2 preferred stock. The Company recorded 5% dividend accretion on total outstanding Series B-2 preferred stock and the total dividends accrued of approximately $15,000 are treated as interest during the year ended June 30, 2021, respectively.

 

Terms of the 2020 Series B-2 5% convertible 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-2 5% Convertible Preferred Stock filed with the Nevada Secretary of State on December 4, 2020 (the “Certificate of Designation”). Each share of preferred stock has an initial stated value of $1,080and 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) $0.35 until August 15, 2021 and $0.50 thereafter, 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 90 days after the scheduled date for the second closing date, 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.

 

 
22

Table of Contents

 

2020 Series B-2 5% convertible preferred stock warrants

 

Each share of preferred stock was sold together with two warrants: (i) a Series 1 warrant, which entitles the holder thereof to purchase one share of preferred stock at $982.50 per share, or 5,089 shares of preferred stock in the aggregate for approximately $5.0 million in aggregate exercise price, for a period of up to 18 months following issuance, and (ii) a Series 2 warrant, which entitles the holder thereof to purchase one shares of preferred stock at $982.50 per share, or 5,089 shares of preferred stock in the aggregate for approximately $5.0 million in aggregate exercise price, for a period of up to 24 months following issuance.

 

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 10 days following the Company’s payment of the call fee, provided that the warrant holders have not exercised the warrants prior to cancellation.

 

Exercise of 2020 Series B-2 5% convertible preferred stock warrants

 

During the three months ended September 30, 2021, the Company issued 3,036 shares of its Series B-2 5% convertible preferred stock, for aggregate gross proceeds of $2,983,000, upon exercise of 3,036 Series 1 warrants issued by the Company. With regard to the exercise of these 3,036 warrants, the Company recorded gross proceeds of approximately $2,983,000 to the preferred stock liability. As of September 30, 2021, 2,036 Series 2 warrants to purchase 2,036 shares of Series B-2 5% convertible preferred stock were outstanding.

 

During the period from December 4, 2020 (date of securities purchase agreement) to June 30, 2021, the Company issued 3,053 shares of its Series B-2 5% convertible preferred stock, for aggregate gross proceeds of $2,999,573, upon exercise of 3,053 Series 1 warrants issued by the Company. In addition, the Company issued 2,053 shares of its Series B-2 5% convertible preferred stock, for aggregate gross proceeds of $2,017,073, upon exercise of 2,053 Series 2 warrants issued by the Company. With regard to the exercise of these 5,106 warrants, the Company recorded gross proceeds of approximately $5,017,000 to the preferred stock liability. As of June 30, 2021, 5,072 Series 1 and 2 warrants to purchase 5,072 shares of Series B-2 5% convertible preferred stock were outstanding.

 

Conversion of 2020 Series B-2 5% convertible preferred stock to common stock

 

During the three months ended September 30, 2021, the 2020 Series B-2 5% convertible preferred stockholder converted a total of 3,036 shares of Series B-2 preferred stock into a total of 18,939,080 shares of common stock. With regard to conversions, the Company reversed Series B-2 5% convertible preferred stock liability relating to the conversion and recorded as Additional paid-in capital at par value. The Company reversed the amount of approximately $2,983,000 based on the proportion of Series B-2 5% convertible preferred stock converted relative to the original total issued.

 

During the period from December 4, 2020 (date of securities purchase agreement) to June 30, 2021, the 2020 Series B-2 5% convertible preferred stockholder converted a total of 10,207 shares of Series B-2 preferred stock into a total of 68,034,812 shares of common stock. With regard to conversions, the Company reversed Series B-2 5% convertible preferred stock liability relating to the conversion and recorded as Additional paid-in capital at par value. The Company reversed the amount of approximately $10,017,000 based on the proportion of Series B-2 5% convertible preferred stock converted relative to the original total issued.

 

As of September 30, 2021 and June 30, 2021, there are no 2020 Series B-2 5% convertible preferred stock outstanding and the 2020 Series B-2 5% convertible preferred stock liability is $0.

 

 
23

Table of Contents

 

Treasury Stock

 

Regarding the exercise of options to purchase 2.2 million shares of Class B common stock on September 8, 2020 by Mr. Ehrlich, the Company issued 1,787,762 shares of Class B common stock (net share issuance amount), to Mr. Ehrlich. The remaining 412,238 shares of Class B common stock were withheld from Mr. Ehrlich for the payment of payroll taxes and were reported by the Company as treasury stock, at cost, on the Company’s accompanying balance sheets.

 

Regarding the exercise of options to purchase 909,090 shares of Class B common stock on October 2, 2020, the Company issued 727,994 shares of Class B common stock (net share issuance amount), to Mr. Ehrlich. The remaining 181,096 shares of Class B common stock were withheld were withheld from Mr. Ehrlich for the payment of payroll taxes and were reported by the Company as treasury stock, at cost, on the Company’s accompanying balance sheets.

 

Regarding the exercise of options to purchase 13,072,730 shares of Class B common stock on December 28, 2020, the Company cancelled 6,980,583 shares of Class A common stock held by Mr. Ehrlich of $1,438,000 to satisfy the exercise price. The Company withheld 1,765,203 shares of Class B common stock and cancelled additional 854,419 shares of Class A common stock held by Mr. Ehrlich. As a result, the Company issued 11,307,527 shares of Class B common shares (net of 1,765,203 shares of Class B common shares withheld to satisfy taxes), and cancelled 7,835,002 shares of Class A common stock held by Mr Ehrlich. Both the 1,765,203 shares of Class B common stock and the 7,835,002 shares of Class A common stock were reported by the Company as treasury stock, at cost, on the Company’s accompanying balance sheets.

 

There were 8,516,056 shares of Class A common stock and 2,358,537 shares of Class B common stock held in treasury, purchased at a total cumulative cost of approximately $2.3 million as of September 30, 2021 and June 30, 2021.

 

15. 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:

 

A financial asset or liability’s classification within the hierarchy is determined based on the lowest level of input that is significant to the fair value measurement.

 

The three levels of valuation hierarchy are defined as follows:

 

 

Level 1: Observable inputs such as quoted prices in active markets;

 

 

 

 

Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

 

 

 

 

Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.

 

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-2 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.

 

 
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Table of Contents

 

16. Subsequent Events

 

CEO Employment Agreement

 

The Compensation Committee approved and the Board of Directors ratified on October 10, 2021, a new employment agreement between the Company and Leo Ehrlich, the Company’s Chief Executive Officer. Mr. Ehrlich’s previous employment agreement expired in January 2015 and Mr. Ehrlich had served without an employment agreement since such time. The employment agreement continues Mr. Ehrlich’s current base salary of $475,000 per year and provides for (i) performance share awards under the Company’s 2016 Equity Incentive Plan, as amended with a maximum value of up to $35.0 million, contingent upon the achievement of certain market capitalization, licensing revenue and clinical trial performance goals, and (ii) cash awards with a maximum value of up to $14.0 million, contingent upon the achievement of certain market capitalization and licensing revenue goals.

 

Amendments to the 2016 Equity Incentive Plan

 

The Compensation Committee approved, and the Board of Directors ratified on October 10, 2021, amendments to the Plan to increase the number of shares of common stock available for issuance thereunder to 225 million shares, among other amendments.

 

Annual Stock Option Awards

 

The Compensation Committee approved stock option awards under the Plan relating to one million shares of common stock to each independent director and 500,000 shares of common stock to Mr. Ehrlich and the Company's Senior Vice President, Clinical Sciences and Portfolio Management.

 

Equity Transaction

 

On November 4, 2021, the Company issued 2,036 shares of its Series B-2 5% convertible preferred stock, for aggregate gross proceeds of approximately $2 million, upon exercise of 2,036 Series 2 warrants issued by the Company.

 

The Company has evaluated events subsequent to September 30, 2021 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 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 OF OUR BUSINESS

 

Overview

 

Innovation Pharmaceuticals Inc. is a clinical stage pharmaceutical company developing innovative therapies with anti-infective, oncology, anti-inflammatory and dermatology applications. The Company owns the rights to Brilacidin, our lead drug in a new class of compounds called defensin-mimetics, and Kevetrin (thioureidobutyronitrile), our anti-cancer compound.

 

Recent Developments

 

Brilacidin is being studied by the Company, as well as other independent researchers, as a potential broad-spectrum antiviral therapeutic for the treatment of viruses including the novel coronavirus (SARS-CoV-2), which is responsible for COVID-19.

 

In December 2020, the U.S. Food and Drug Administration (FDA) approved the Company’s Investigational New Drug (IND) application to proceed with initiation of a randomized, placebo-controlled Phase 2 clinical trial of Brilacidin in moderate-to-severe hospitalized patients with COVID-19. Similar regulatory approval was obtained from the Russian Ministry of Health.

 

In January 2021, the FDA designated as a Fast Track development program the investigation of Brilacidin for the treatment for COVID-19.

 

In February 2021, the clinical trial of Brilacidin for treating hospitalized patients with COVID-19 in the United States and Russia began with patients being recruited to the study.

 

On February 9, 2021, antiviral results demonstrating Brilacidin’s inhibition of SARS-CoV-2 in cell culture were published in the journal Viruses.

 

In April 2021, the COVID-19 clinical trial’s independent Data Monitoring Committee (DMC) completed its scheduled review of interim safety data. Upon reaching 25 percent enrollment (30 subjects), recruitment was paused and a pre-specified unblinded safety data review and evaluation was conducted by the DMC. The DMC recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, as intended per the protocol, which the Company implemented.

 

In June 2021, 100 percent of the planned number of patients (n=120) were randomized in the study.

 

In July 2021, new in vitro data supporting Brilacidin’s broad-spectrum antiviral potential were presented by George Mason University/National Center for Biodefense and Infectious Disease researchers at the American Society of Virology’s Annual Meeting. Brilacidin showed inhibition in multiple human cell lines and in different strains of alphaviruses and bunyaviruses, building on earlier antiviral work in coronaviruses.

 

In July 2021, the independent DMC completed a second review of interim safety data from the Phase 2 clinical trial of Brilacidin in moderate-to-severe hospitalized patients with COVID-19. From their review, the DMC agreed to recommend the trial continue with no further modifications to the protocol.

 

 
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On July 30, 2021, the last subject’s final visit occurred in the Company’s COVID-19 clinical trial.

 

On August 2, 2021, the Company provided an update on ongoing Brilacidin antiviral laboratory research being conducted by different groups of scientists. Their research includes insights into Brilacidin’s antiviral mechanisms of action as well as in vitro data supporting Brilacidin’s inhibition of the Alpha and Gamma variants and different strains of human coronaviruses.

 

The Company has received individual patient Expanded Access (compassionate use) requests for Brilacidin to treat critically ill COVID-19 patients who are not responding to prior therapy. Expanded Access was implemented by the FDA and Congress to address physician applications for access to potentially lifesaving drugs, prior to FDA approval, for patients in their care when available treatment options have failed. Following receipt of such requests, the Company has supplied Brilacidin to relevant hospitals for individual patient use, with the FDA granting the treating physician permission for the emergency administration of Brilacidin.

 

The Phase 2 COVID-19 clinical trial data as of the date of this Form 10-Q remains blinded to the Company. The Company’s biostatistics vendor is currently engaged in analyzing and computing study data and they are expected to deliver Topline results to the Company during the second week of November, 2021.

 

Business Development and Licensing

 

The Company is actively engaged in business development and licensing initiatives with multiple specialty and global pharmaceutical companies. 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 S.p.A. (“Alfasigma”), granting Alfasigma the worldwide right to develop, manufacture and commercialize rectally administered Brilacidin for ulcerative proctitis/ulcerative proctosigmoiditis (“UP/UPS”). The license agreement 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, as well as a right of first negotiation for Brilacidin in other gastrointestinal indications. In January 2021, Alfasigma notified the Company that the Phase 1 study for the treatment of UP/UPS using Brilacidin in a proprietary Alfasigma formulation successfully completed dosing per protocol; an extra treatment cohort was subsequently added by amendment and commenced in May 2021. In latest updates on UP/UPS development planning, Alfasigma notified the Company that regulatory submissions for a Phase 2 multinational clinical trial will commence from early 2022; Alfasigma has ordered Brilacidin drug substance from the Company for use in this study. The Company is eligible to receive $24 million in upfront and milestone payments, and a 6 percent royalty (net sales) upon the successful marketing of Brilacidin for UP/UPS.

 

On July 22, 2020, the Company and Fox Chase Chemical Diversity Center, Inc. (“FCCDC”) amended an earlier collaborative research agreement related to antifungal drug discovery work to which the Company had rights. In exchange for a six (6) percent fee tied to all potential future proceeds, the Company granted FCCDC all discovery, intellectual property and commercialization rights related to its share of their joint antifungal drug program.

 

 
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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 UP/UPS Proof of Concept Study (completed)

Phase 1 Safety/toleration/PK of oral dosage form (completed)

Phase 2 UC Safety/toleration/PK and Proof of Concept in preparation

 

ABSSSI (Acute Bacterial Skin and Skin Structure Infection)

Phase 2 (completed)

 

COVID-19

Phase 2 Study

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 drugs. Developing pharmaceutical products, however, is a lengthy and very expensive process and there can be no assurance that we will complete such development or commercialize such pharmaceutical products for several years, if ever.

 

The Company devotes most of its efforts and resources on Brilacidin, which is 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:

 

Brilacidin

 

COVID-19 — Due to the global COVID-19 pandemic, the Company was approached by a number of organizations to research Brilacidin against the novel coronavirus (COVID-19). Material Transfer Agreements were signed with two academic institutions that operate Biosafety Level 3 Laboratories (BSL-3). Brilacidin drug substance (Brilacidin tetrahydrochloride) was provided for antiviral research.

 

The research data demonstrated that Brilacidin exerts potent inhibition of SARS-CoV-2 and thus supported Brilacidin as a promising COVID-19 drug candidate for clinical studies. Also of note, Brilacidin in these research studies demonstrated excellent synergistic antiviral activity when combined with Remdesivir, a broad-spectrum antiviral medication.

 

Research Highlights:

 

Brilacidin potently inhibits SARS-CoV-2 in an ACE2 positive human lung cell line.

Brilacidin achieved a high Selectivity Index of 426 (CC50=241μM/IC50=0.565μM).

Brilacidin’s main mechanism appears to disrupt viral integrity and impact viral entry.

Brilacidin and Remdesivir exhibit excellent synergistic activity against SARS-CoV-2.

 

In a broader context, demonstration of Brilacidin’s direct antiviral activity against the SARS-CoV-2 virus supports the drug’s unique 3-in-1 therapeutic potential—antiviral, anti-inflammatory, antimicrobial—to treat COVID-19 and its associated complications.

 

 
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A Phase 2 clinical trial of intravenously-administered Brilacidin for COVID-19 conducted at sites in the United States and Russa has since completed (n=120), and the clinical trial database has been locked with data analyses ongoing. Topline outputs are expected the week of November 8, 2021, followed by all planned data outputs by the end of November 2021. The study is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in COVID-19 hospitalized patients. The trial’s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes (e.g., duration of hospitalization, time to discharge), all-cause mortality, measurement of disease biomarkers (e.g., CRP, ferritin) and inflammation-related biomarkers (e.g., IL-1β, IL-6, IL-10, total IL-18, TNF-α), changes to SARS-CoV-2 viral load, as well as other key measures.

 

In April 2021, the clinical trial’s independent DMC completed its scheduled review of interim safety data. Upon reaching 25 percent enrollment (30 subjects), recruitment was paused and a pre-specified unblinded safety data review and evaluation was conducted by the DMC. The DMC recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, as intended per the protocol, which the Company implemented. In July 2021, the independent DMC completed a second review of interim safety data; based on their review, the DMC agreed to recommend the trial continue with no further modifications to the protocol.

 

The Company is collaborating with a Regional Biocontainment Laboratory researcher investigating further research opportunities with Brilacidin as a treatment for the SARS-CoV-2 virus, other Human Coronaviruses (H-CoVs), and other types of viruses. Further, grant applications for federally-funded research are pending, and further grant applications are planned.

 

IBD, Ulcerative Proctitis/Proctosigmoiditis (UP/UPS) study —A Phase 2a trial has previously been completed by the Company, comprised of 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. In July 2019, the Company entered into a license agreement with Alfasigma, granting Alfasigma the worldwide right to develop, manufacture and commercialize rectally administered Brilacidin for UP/UPS. In January 2021, Alfasigma notified the Company that the Phase 1 study for the treatment of UP/UPS using Brilacidin in a proprietary Alfasigma formulation successfully completed dosing per protocol; an extra treatment cohort was subsequently added by amendment and commenced in May 2021. In latest updates on UP/UPS development planning, Alfasigma notified the Company that regulatory submissions for a Phase 2 multinational clinical trial will commence from early 2022; Alfasigma has ordered Brilacidin drug substance from the Company for use in this study. See Note 7. Exclusive License Agreement of the notes to condensed consolidated financial statements.

 

IBD, Ulcerative Colitis (UC) — Brilacidin is also being developed as a treatment in more extensive forms of IBD.

 

Development of a delayed release oral formulation has been in progress, with development work expanding into immediate release formulations due to unexpected findings encountered. Such findings appear due to the inherent physiochemical properties of the compound, and those of polymers used to achieve delayed release. An immediate release, multi-particulate capsule formulation has been developed and a ‘research and development’ batch has progressed to stability testing at the manufacturing vendor. Further work is ongoing, in preparation for manufacture of clinical trial supplies.

 

Based on these recent findings, the development plan for ulcerative colitis has been adapted with inclusion of Phase 1 testing of the immediate release oral formulation. Clinical trials will be able to progress pending completion of clinical trial supply manufacturing (currently scheduled for January 2022) and securing sufficient working capital.

 

 
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Oral Mucositis (OM) study — In a 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), 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 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 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.

 

Development of an optimized oral rinse formulation is in progress, with potential to progress to Phase 3 clinical trials in 2022, pending completion of drug formulation work and securing sufficient drug supply and working capital.

 

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 the FDA due to the low price per share of our common stock and the many multiple million dollar costs associated with a Phase 3 program. 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 $1.3 million and $0.3 million during the quarters ended September 30, 2021 and 2020, respectively.

 

For Brilacidin overall, we see significant potential in treatment of COVID-19 (by the IV route), and in treatment of Oral Mucositis (by oral rinse) and IBD (by oral capsule or tablet). The available clinical data also suggest that other inflammatory conditions including various dermatology disorders and conditions may, likewise, be treated locally and efficaciously with Brilacidin.

 

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. Presently we are focusing our resources on Brilacidin, our other lead candidate.

 

Expenditures on Kevetrin were insignificant during the quarters ended September 30, 2021 and 2020, respectively.

 

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 and there can be no assurance that we will complete such development or commercialize such for several years, if ever.

 

 
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Management’s Plan of Operation

 

The Company devotes most of its efforts and resources on drug development, regulatory matters, and clinical trials. Presently, our efforts are primarily focused on evaluating our drug candidate Brilacidin; as a therapeutic for coronaviruses, particularly SARS-CoV-2, the novel coronavirus responsible for COVID-19; for decreasing the incidence of severe oral mucositis as a complication of chemoradiation; for treatment of IBD; and for treatment of skin infections. Our other drug candidate, Kevetrin, is for the treatment of cancer. 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.

 

In the ordinary course of business, we engage in a continual review of opportunities to license our drug compounds and enter into partnering, joint development or similar arrangements with other companies. We currently, and generally at any time, have such opportunities in various stages of active review, including, for example, entry into indications of interest and term sheets and participation in preliminary discussions and negotiations. Any such transaction could be material to us.

 

As a result of the advent of the COVID-19 pandemic, we were approached by several organizations, including two academic institutions having Biosafety Level 3 Laboratories (BSL-3), interested in evaluating Brilacidin as an experimental new drug for COVID-19 and its underlying coronavirus (SARS-CoV-2). Early research indicated that Brilacidin was a promising therapeutic candidate and subsequent extensive pre-clinical research in multiple human cell lines have lent further evidence and support for continued research into Brilacidin’s antiviral properties. Brilacidin has shown consistent in vitro inhibition in a cell-type independent manner in different strains of coronaviruses, alphaviruses and bunyaviruses. In light of the ongoing pandemic and drug development environment, we have prioritized development of Brilacidin for COVID-19, including the conduct of a Phase 2 randomized, blinded, placebo-controlled clinical trial of Brilacidin in patients hospitalized with moderate-to-severe COVID-19. The trial has since completed (n=120), and the clinical trial database has been locked with data analyses ongoing. Topline outputs are expected the week of November 8, 2021, followed by all planned data outputs by end November 2021.

 

Brilacidin formulation development work is in progress: For treating ulcerative colitis, we are engaged in the development of an oral formulation (i.e. capsule or tablet). For treating oral mucositis we are engaged in optimizing an oral rinse formulation for the treatment of severe oral mucositis.

 

Critical Accounting Policies and Estimates

 

Management’s discussion and analysis of financial condition and results of operations are based upon our accompanying financial statements, which have been prepared in conformity with U.S. generally accepted accounting principles, or 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. Note 3. Significant Accounting Policies and Recent Accounting Pronouncements, to the financial statements, describes the significant accounting policies and methods used in the preparation of the Company’s financial statements. 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.

 

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.

 

 
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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. We currently anticipate that future budget expenditures will be approximately $10.7 million for the next 12 months, including approximately $8.7 million for clinical activities, supportive research, and drug product. 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 September 30, 2021 and 2020

 

Revenue

 

We generated no revenue and incurred operating expenses of approximately $2.0 million and $1.1 million for the three months ended September 30, 2021 and 2020, 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 (rounded to nearest thousand):

 

 

 

For the three months ended

 

 

Change

 

 

 

September 30,

 

 

2021 vs. 2020

 

 

 

2021

 

 

2020

 

 

 $

 

 

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Clinical studies and development research

 

$ 1,338,046

 

 

$ 298,000

 

 

 

1,040,046

 

 

 

349 %

Employees payroll and payroll tax expenses related to R&D Department

 

 

141,000

 

 

 

70,000

 

 

 

71,000

 

 

 

101 %

Stock-based compensation – employee

 

 

11,000

 

 

 

19,000

 

 

 

(8,000 )

 

 

(42 )%

Stock-based compensation – consultants

 

 

29,000

 

 

 

43,000

 

 

 

(14,000 )

 

 

(33 )%

Depreciation and amortization expenses

 

 

71,954

 

 

 

94,000

 

 

 

(22,046 )

 

 

(23 )%

Total

 

$ 1,591,000

 

 

$ 524,000

 

 

 

1,067,000

 

 

 

204 %

 

Research and development expenses for proprietary programs increased during the three months ended September 30, 2021 compared with the three months ended September 30, 2020, primarily due to more spending on our Brilacidin program for the three months ended September 30, 2021.

 

Employees payroll and payroll tax expenses increased during the three months ended September 30, 2021 compared with the three months ended September 30, 2020, due to a new hire of an employee during the three months ended September 30, 2021.

 

Stock-based compensation for employee decreased during the three months ended September 30, 2021 due to equity-based awards issued to an employee in 2016 and in 2017 being fully expensed during the year ended June 30, 2021, therefore, less stock-based compensation – employee was incurred during the three months ended September 30, 2021.

 

Stock-based compensation - consultants decreased during the three months ended September 30, 2021 due to less options being issued to consultants during the three months ended September 30, 2021 compared with the three months ended September 30, 2020.

 

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. Clinical studies and development expenses may decrease in future reporting periods depending on the Company’s current and future financial liquidity. We manage our proprietary programs based on scientific data and achievement of research plan goals. 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.

 

 
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General and Administrative Expenses

 

General and administrative expenses consist mainly of compensation and associated fringe benefits not included in the 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, sales commissions, facilities, depreciation and other office expenses.

 

Below is a summary of our general and administrative expenses (rounded to nearest thousand):

 

 

 

For the three months ended

 

 

Change

 

 

 

September 30,

 

 

2021 vs. 2020

 

 

 

2021

 

 

2020

 

 

 $

 

 

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Insurance and health expense

 

$ 69,051

 

 

$ 118,000

 

 

 

(48,949 )

 

 

(41 )%

Rent and utility expense

 

 

21,152

 

 

 

27,000

 

 

 

(5,848 )

 

 

(22 )%

Business development expense

 

 

25,000

 

 

 

48,100

 

 

 

(23,100 )

 

 

(48 )%

Other G&A

 

 

69,797

 

 

 

70,900

 

 

 

(1,103 )

 

 

(2 )%

Total

 

$ 185,000

 

 

$ 264,000

 

 

 

(79,000 )

 

 

(30 )%

 

General and administrative expenses decreased during the three months ended September 30, 2021, primarily due to the decrease in insurance and health expense of $49,000 and decrease in business development expense of $23,000 due to less business development consultants’ fees and business events during the three months ended September 30, 2021.

 

Officers’ Payroll and Payroll Tax Expenses

 

Below is a summary of our Officers’ payroll and payroll tax expenses (rounded to nearest thousand):

 

 

 

Three months ended

 

 

Change

 

 

 

September 30,

 

 

2021 vs. 2020

 

 

 

2021

 

 

2020

 

 

 $

 

 

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Officers’ payroll and payroll tax expenses

 

$ 119,000

 

 

$ 127,000

 

 

 

(8,000 )

 

 

(6 )%

 

There was a slight decrease in officers’ payroll and payroll tax expenses for the Company during the three months ended September 30, 2021, due to the decrease in payroll taxes.

 

Professional Fees

 

Below is a summary of our Professional fees (rounded to nearest thousand):

 

 

 

Three months ended

 

 

Change

 

 

 

September 30,

 

 

2021 vs. 2020

 

 

 

2021

 

 

2020

 

 

 $

 

 

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Audit, legal and professional fees

 

$ 128,000

 

 

$ 214,000

 

 

 

(86,000 )

 

 

(40 )%

 

Professional fees decreased during the three months ended September 30, 2021 primarily related to decrease in legal fees and other professional fees in 2021.

 

 
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Other Income (Expense)

 

Below is a summary of our other income (expense) (rounded to nearest thousand):

 

 

 

For the Three months ended

 

 

Change

 

 

 

September 30,

 

 

2021 vs. 2020

 

 

 

2021

 

 

2020

 

 

 $

 

 

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense – debt

 

 

(33,000 )

 

 

(44,000 )

 

 

11,000

 

 

 

(25 )%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Income (Expense), net

 

$ (33,000 )

 

$ (44,000 )

 

$ 11,000

 

 

 

(25 )%

 

There was a decrease in interest expenses paid on the note payable – related party, because of the decrease in the note payable balance due to the Company’s Chairman and CEO since he exercised his options to purchase 3.1 million shares of Class B common stock by the cancellation of debt during the year ended June 30, 2021 (see Note 11. Convertible Note Payable – Related Party of the Notes to Condensed Consolidated Financial Statements).

 

Net Losses

 

We incurred net losses of $2.1 million and $1.2 million for the three months ended September 30, 2021 and 2020, respectively, because of the above-mentioned factors.

 

Liquidity and Capital Resources

 

Projected Future Working Capital Requirements - Next 12 Months

 

As of September 30, 2021, we had approximately $11.2 million in cash compared to $10.2 million of cash as of June 30, 2021, and as of the date of this filing, we have approximately $10.2 million in cash. We currently anticipate that future budget expenditures will be approximately $10.7 million for the next 12 months, including approximately $8.7 million for clinical activities, supportive research, and drug product. Alternatively, if we decide to pursue a more aggressive plan with our clinical trials, we will require additional sources of capital during the fiscal year 2022 to meet our working capital requirements for our planned clinical trials. Potential sources for capital include grant funding for COVID-19 research and equity financings (see below). There can be no assurances that we will be successful in receiving any grant funding for our programs.

 

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 above working capital projection.

 

On July 31, 2020, the Company entered into a new common stock purchase agreement (the “2020 Agreement”) with Aspire Capital which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $30.0 million of the Company’s common stock over the 24-month term of the 2020 Agreement.

 

Our ability to successfully raise sufficient funds through the sale of equity securities, when needed, is subject to many risks and uncertainties and even if we are successful, future equity issuances would result in dilution to our existing stockholders. Our risk factors are described under the heading “Risk Factors” in Part I, Item 1A and elsewhere in this Annual Report on Form 10-K.

 

If we are unable to generate enough working capital from our current or future financing agreements with Aspire Capital when needed or secure additional sources of funding, it may be necessary to significantly reduce our current rate of spending through reductions in staff and delaying, scaling back or stopping certain research and development programs, including more costly Phase 2 and Phase 3 clinical trials on our wholly-owned development programs as these programs progress into later stage development. Insufficient liquidity may also require us to relinquish greater rights to product candidates at an earlier stage of development or on less favorable terms to us and our stockholders than we would otherwise choose in order to obtain up-front license fees needed to fund operations. These events could prevent us from successfully executing our operating plan.

 

 
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Shelf Registration Statement - Current Status

 

The Company has an effective shelf registration statement on Form S-3, registering the sale of up to $60 million of the Company’s securities. However, in the future, the Company may not satisfy the conditions for use of Form S-3 for primary offerings of securities, in which case the Company may 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 for the three months ended September 30, 2021 and 2020 (rounded to nearest thousand):

 

 

 

Three Months Ended

 

 

Change

 

 

 

September 30,

 

 

Increase/

 

 

 

2021

 

 

2020

 

 

(Decrease)

 

 

 

 

 

 

 

%

 

Net cash used in operating activities

 

$ (1,954,000 )

 

$ (1,521,000 )

 

 

28 %

Net cash used in investing activities

 

 

(17,000 )

 

 

(3,000 )

 

 

467 %

Net cash provided by financing activities

 

 

2,983,000

 

 

 

2,758,000

 

 

 

8 %

Net increase in cash

 

$ 1,012,000

 

 

$ 1,234,000

 

 

 

(18 )%

 

The increase in net cash used in operating activities of $0.4 million versus the prior-year was mainly due to the increase in our loss from operations of $0.9 million, largely attributable to an increase in spending for clinical research and development expenses of $1.1 million. This also included the repayment of accrued officers’ salaries of $0.3 million.

 

The use of cash principally resulted from our losses from operations, mentioned above, as adjusted for non-cash charges for stock-based compensation of $40,000, patent amortization of $95,000, and changes in our working capital accounts.

 

Investing activities

 

The increase in net cash used in investing activities versus the prior-year was due to an increase in spending in patent costs.

 

Financing activities

 

During the three months ended September 30, 2021, we raised approximately $3.0 million in net cash proceeds, from exercise of warrants to purchase preferred stock.

 

During the three months ended September 30, 2020, we raised approximately $2.9 million in net cash proceeds, from sale of common stock to Aspire, offset by purchase of treasury stock of $0.1 million.

 

 
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Requirement for Additional Working Capital

 

The Company, contingent on future sales of its securities, currently expects to incur total operating expenses of approximately $10.7 million for the next 12 months, including approximately $8.7 million for clinical activities, supportive research, and drug product development. The Company has limited experience with pharmaceutical drug development. As such, this budget estimate may change in the future. 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 accessing its financing available with Aspire Capital of approximately $30 million, of which approximately $25.4 million remains as of the date of this filing. Management believes, as of the date of this filing that the funding amount from Aspire Capital will be available as needed by the Company and that adverse market conditions in the Company’s common stock price and trading volume, will not prevent the Company from funding its working capital requirements for the next 12 months from the date of this filing.

 

In the event that we are unable to generate sufficient cash from our 2020 Agreement with Aspire Capital or raise additional funds from others, 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 to us.

 

Commitments and Contingencies

 

Please see Note 9. Commitments and Contingencies of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 in this Quarterly Report on Form 10-Q, 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.

 

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 September 30, 2021, 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 September 30, 2021, the principal executive officer and principal financial officer of the Company have 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 September 30, 2021, 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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PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

See Note 9 in the accompanying condensed consolidated financial statements.

 

ITEM 1A. RISK FACTORS

 

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, 2021, 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, 2021.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES

 

None

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None

 

ITEM 4. MINE SAFETY DISCLOSURES

 

None

 

ITEM 5. OTHER INFORMATION

 

None

 

 
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ITEM 6. EXHIBITS

 

(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

 

 

 

 

 

10.1

 

Amendments to the Innovation Pharmaceuticals Inc. 2016 Equity Incentive Plan, as amended.

 

Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on October 14, 2021

 

 

 

 

 

31.1

 

Chief Executive Officer and Chief Financial Officer Certifications required under Section 302 of the Sarbanes Oxley Act of 2002

 

Filed herewith

 

 

 

 

 

32.1

 

Chief Executive Officer and Chief Financial Officer Certifications required under Section 906 of the Sarbanes Oxley Act of 2002

 

Furnished herewith

 

 

 

 

 

101

 

The following materials from the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2021 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

 

 

 

 

 

104

 

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

Filed herewith

 

 
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Table of Contents

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

INNOVATION PHARMACEUTICALS INC.

 

 

 

 

 

Dated: November 9, 2021

By:

/s/ Leo Ehrlich

 

 

Name:

Leo Ehrlich

 

 

Title:

Chief Executive Officer and Chief Financial Officer

(Principal Executive, Accounting and Financial Officer)

 

 

 
39

 

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