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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: December 31, 2022
☐
|
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 February 15, 2023 is as follows:
Class of Securities
|
|
Shares Outstanding
|
Common Stock Class A, $0.0001 par value
|
|
488,322,996
|
Common Stock Class B, $0.0001 par value
|
|
4,333,936
|
INNOVATION PHARMACEUTICALS INC.
FORM 10-Q
For the Quarter Ended December 31, 2022
TABLE OF CONTENTS
FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended, and Section 27A of the Securities Act of 1933, as amended.
Any statements contained in this report that are not statements of
historical fact may be forward-looking statements. When we use the
words “intends,” “estimates,” “predicts,” “potential,” “continues,”
“anticipates,” “plans,” “expects,” “believes,” “should,” “could,”
“may,” “will” or the negative of these terms or other comparable
terminology, we are identifying forward-looking statements. These
forward-looking statements include, but are not limited to, any
statements regarding our future financial performance, results of
operations or sufficiency of capital resources to fund our
operating requirements; statements relating to potential licensing,
partnering or similar arrangements concerning our drug compounds;
statements concerning our future drug development plans and
projected timelines for the initiation and completion of
preclinical and clinical trials; the potential for the results of
ongoing preclinical or clinical trials; other statements regarding
our future product development and regulatory strategies, including
with respect to specific indications; and any other statements
which are other than statements of historical fact. Forward-looking
statements involve risks and uncertainties, which may cause our
actual results, performance or achievements to be materially
different from those expressed or implied by forward-looking
statements. These factors include, but are not limited to, our
ability to continue as a going concern and our capital needs; our
ability to fund and successfully progress internal research and
development efforts; 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.; 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.”
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
INNOVATION PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
AS OF DECEMBER 31, 2022 AND JUNE 30, 2022
(Unaudited)
(Rounded to nearest thousand except for shares
data)
|
|
December 31,
|
|
|
June 30,
|
|
|
|
2022
|
|
|
2022
|
|
ASSETS
|
Current Assets:
|
|
|
|
|
|
|
Cash
|
|
$ |
2,423,000 |
|
|
$ |
3,807,000 |
|
Prepaid expenses and other current assets
|
|
|
101,000 |
|
|
|
145,000 |
|
Total Current Assets
|
|
|
2,524,000 |
|
|
|
3,952,000 |
|
|
|
|
|
|
|
|
|
|
Equity investment
|
|
|
3,933,000 |
|
|
|
3,978,000 |
|
|
|
|
|
|
|
|
|
|
Other Assets:
|
|
|
|
|
|
|
|
|
Patent costs - net
|
|
|
2,156,000 |
|
|
|
2,312,000 |
|
Deferred offering costs
|
|
|
— |
|
|
|
59,000 |
|
Security deposit
|
|
|
78,000 |
|
|
|
78,000 |
|
Total Other Assets
|
|
|
2,234,000 |
|
|
|
2,449,000 |
|
Total Assets
|
|
$ |
8,691,000 |
|
|
$ |
10,379,000 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
Current Liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable - (including related party payables of approx.
$1,511,000 and $1,511,000, respectively)
|
|
$ |
2,696,000 |
|
|
$ |
2,567,000 |
|
Accrued expenses - (including related party accruals of approx.
$15,000 and $12,000, respectively)
|
|
|
65,000 |
|
|
|
92,000 |
|
Accrued salaries and payroll taxes - (including related party
accrued salaries of approx. $1,588,000 and $1,563,000,
respectively)
|
|
|
1,661,000 |
|
|
|
1,640,000 |
|
Operating lease - current liability
|
|
|
158,000 |
|
|
|
197,000 |
|
Convertible note payable - related party
|
|
|
235,000 |
|
|
|
250,000 |
|
Accrued dividend - Series B 5% convertible preferred stock
|
|
|
9,000 |
|
|
|
62,000 |
|
Total Current Liabilities
|
|
|
4,824,000 |
|
|
|
4,808,000 |
|
Other Liabilities:
|
|
|
|
|
|
|
|
|
Series B 5% convertible preferred stock liability at $1,080 stated
value; 620 shares issued and outstanding at December 31, 2022 and
June 30, 2022
|
|
|
786,000 |
|
|
|
786,000 |
|
Operating lease - long term liability
|
|
|
— |
|
|
|
55,000 |
|
Total Liabilities
|
|
|
5,610,000 |
|
|
|
5,649,000 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (Note 10)
|
|
|
|
|
|
|
|
|
Stockholders’ Equity
|
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 designated shares, no
shares issued and outstanding
|
|
|
— |
|
|
|
— |
|
Common Stock - Class A, $0.0001 par value, 600,000,000 shares
authorized, 496,839,052 shares and 496,741,729 shares issued as of
December 31, 2022 and June 30, 2022, respectively, 488,322,996
shares and 488,225,673 shares outstanding as of December 31, 2022
and June 30, 2022, respectively.
|
|
|
49,000 |
|
|
|
49,000 |
|
Common Stock - Class B, (10 votes per share); $0.0001 par value,
100,000,000 shares authorized, 6,692,473 shares and 18,000,000
shares issued as of December 31, 2022 and June 30, 2022, and
4,333,936 shares and 15,641,463 shares outstanding as of December
31, 2022 and June 30, 2022, respectively
|
|
|
1,000 |
|
|
|
2,000 |
|
Additional paid-in capital
|
|
|
129,231,000 |
|
|
|
129,090,000 |
|
Accumulated deficit
|
|
|
(123,946,000 |
) |
|
|
(122,157,000 |
) |
Treasury Stock, at cost (10,874,593 shares as of December 31, 2022
and June 30, 2022)
|
|
|
(2,254,000 |
) |
|
|
(2,254,000 |
) |
Total Stockholders’ Equity
|
|
|
3,081,000 |
|
|
|
4,730,000 |
|
Total Liabilities and Stockholders’ Equity
|
|
$ |
8,691,000 |
|
|
$ |
10,379,000 |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements
INNOVATION PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
FOR THE THREE MONTHS AND SIX MONTHS ENDED DECEMBER 31, 2022
AND 2021
(Unaudited)
(Rounded to nearest thousand except for shares and per
share data)
|
|
For the three Months
Ended
|
|
|
For the Six Months
Ended
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
|
(33,000 |
) |
|
|
1,593,000 |
|
|
|
836,000 |
|
|
|
3,184,000 |
|
General and administrative expenses
|
|
|
191,000 |
|
|
|
266,000 |
|
|
|
482,000 |
|
|
|
451,000 |
|
Officers’ payroll and payroll tax expenses
|
|
|
118,000 |
|
|
|
63,000 |
|
|
|
236,000 |
|
|
|
182,000 |
|
Professional fees
|
|
|
57,000 |
|
|
|
92,000 |
|
|
|
161,000 |
|
|
|
220,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
333,000 |
|
|
|
2,014,000 |
|
|
|
1,715,000 |
|
|
|
4,037,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Operating Income and (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in loss from an investment
|
|
|
(14,000 |
) |
|
|
— |
|
|
|
(45,000 |
) |
|
|
— |
|
Total Other Operating Income and (Loss)
|
|
|
(14,000 |
) |
|
|
— |
|
|
|
(45,000 |
) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(347,000 |
) |
|
|
(2,014,000 |
) |
|
|
(1,760,000 |
) |
|
|
(4,037,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
|
|
|
— |
|
|
|
172,000 |
|
|
|
— |
|
|
|
172,000 |
|
Interest expense – debt
|
|
|
(5,000 |
) |
|
|
(17,000 |
) |
|
|
(12,000 |
) |
|
|
(50,000 |
) |
Interest expense - preferred stock liability
|
|
|
(9,000 |
) |
|
|
(14,000 |
) |
|
|
(17,000 |
) |
|
|
(14,000 |
) |
Other expense, net
|
|
|
(14,000 |
) |
|
|
141,000 |
|
|
|
(29,000 |
) |
|
|
108,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision for income taxes
|
|
|
(361,000 |
) |
|
|
(1,873,000 |
) |
|
|
(1,789,000 |
) |
|
|
(3,929,000 |
) |
Provision for income taxes
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(361,000 |
) |
|
$ |
(1,873,000 |
) |
|
$ |
(1,789,000 |
) |
|
$ |
(3,929,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to common
stockholders
|
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average number of common
shares
|
|
|
503,841,551 |
|
|
|
457,008,040 |
|
|
|
503,864,393 |
|
|
|
451,890,474 |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
INNOVATION PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
FOR THE THREE MONTHS AND SIX MONTHS ENDED DECEMBER 31, 2022
AND 2021
(Unaudited)
(Rounded to nearest thousand, except for shares
data)
For the Three and Six Months Ended December 31,
2021
|
|
Common Stock A
|
|
|
Common Stock B
|
|
|
Additional |
|
|
|
|
|
Treasury Stock
|
|
|
Total |
|
|
|
|
|
|
Par Value
|
|
|
|
|
|
Par Value
|
|
|
Paid-in
|
|
|
Accumulated
|
|
|
|
|
|
Stockholders’ |
|
|
|
Shares
|
|
|
$0.0001
|
|
|
Shares
|
|
|
$0.0001
|
|
|
Capital
|
|
|
Deficit
|
|
|
Shares
|
|
|
Amount
|
|
|
Equity
|
|
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 –September 30, 2021
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Offering cost
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(180,000 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(180,000 |
) |
Restricted stock awards of common stock issued to employee for
services at $0.132 to $0.398
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,000 |
|
Stock options issued to employee for services at $0.132 to
$0.398
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
27,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
27,000 |
|
Stock options issued to consultants for services at $0.14 to
$0.384
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12,000 |
|
Stock options issued to director for services at $0.24
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
111,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
111,000 |
|
Conversion of 536 shares of preferred stock into 7,854,545 shares
of common stock
|
|
|
7,854,545 |
|
|
|
1,000 |
|
|
|
— |
|
|
|
— |
|
|
|
525,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
526,000 |
|
Shares of common stock issued for exercise of options
|
|
|
166,666 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
23,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
23,000 |
|
Net loss for the three months ended December 31, 2021
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,873,000 |
) |
|
|
— |
|
|
|
— |
|
|
|
(1,873,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2021
|
|
|
445,117,433 |
|
|
$ |
45,000 |
|
|
|
15,641,463 |
|
|
$ |
2,000 |
|
|
$ |
128,197,000 |
|
|
$ |
(119,045,000 |
) |
|
|
10,874,593 |
|
|
$ |
(2,254,000 |
) |
|
$ |
6,945,000 |
|
For the Three and Six Months Ended December 31,
2022
|
|
Common Stock A
|
|
|
Common Stock B
|
|
|
Additional
|
|
|
|
|
|
Treasury Stock
|
|
|
Total
|
|
|
|
Shares
|
|
|
Par Value
$0.0001
|
|
|
Shares
|
|
|
Par Value
$0.0001
|
|
|
Paid-in
Capital
|
|
|
Accumulated
Deficit
|
|
|
Shares
|
|
|
Amount
|
|
|
Stockholders’ Equity
|
|
Balance at June 30, 2022
|
|
|
488,225,673 |
|
|
$ |
49,000 |
|
|
|
15,641,463 |
|
|
$ |
2,000 |
|
|
$ |
129,090,000 |
|
|
$ |
(122,157,000 |
) |
|
|
10,874,593 |
|
|
$ |
(2,254,000 |
) |
|
$ |
4,730,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Offering cost
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(59,000 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(59,000 |
) |
Restricted common stock award issued to employee for services
|
|
|
97,323 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,000 |
|
Stock options issued to employee for services
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
28,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
28,000 |
|
Stock options issued to consultants for services
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,000 |
|
Stock options issued to director for services
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
147,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
147,000 |
|
Net loss for the three months ended September 30, 2022
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,428,000 |
) |
|
|
— |
|
|
|
— |
|
|
|
(1,428,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2022
|
|
|
488,322,996 |
|
|
$ |
49,000 |
|
|
|
15,641,463 |
|
|
$ |
2,000 |
|
|
$ |
129,209,000 |
|
|
$ |
(123,585,000 |
) |
|
|
10,874,593 |
|
|
$ |
(2,254,000 |
) |
|
$ |
3,421,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Surrender of Shares by a Stockholder
|
|
|
— |
|
|
|
— |
|
|
|
(11,307,527 |
) |
|
|
(1,000 |
) |
|
|
1,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Restricted common stock award issued to employee for services
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,000 |
|
Stock options issued to employee for services
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
5,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
5,000 |
|
Stock options issued to consultants for services
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,000 |
|
Stock options issued to director for services
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
14,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
14,000 |
|
Net loss for the three months ended December 31, 2022
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(361,000 |
) |
|
|
— |
|
|
|
— |
|
|
|
(361,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2022
|
|
|
488,322,996 |
|
|
$ |
49,000 |
|
|
|
4,333,936 |
|
|
$ |
1,000 |
|
|
$ |
129,231,000 |
|
|
$ |
(123,946,000 |
) |
|
|
10,874,593 |
|
|
$ |
(2,254,000 |
) |
|
$ |
3,081,000 |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
INNOVATION PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS
FOR THE SIX MONTHS ENDED DECEMBER 31, 2022 AND
2021
(Unaudited)
(Rounded to nearest thousand, except for shares
data)
|
|
2022
|
|
|
2021
|
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net loss
|
|
$ |
(1,789,000 |
) |
|
$ |
(3,929,000 |
) |
Adjustments to reconcile net loss to net cash used in
operating activities:
|
|
|
|
|
|
|
|
|
Stock based compensation
|
|
|
199,000 |
|
|
|
192,000 |
|
Amortization of patent costs
|
|
|
187,000 |
|
|
|
191,000 |
|
Gain on forgiveness of loans payable
|
|
|
— |
|
|
|
(172,000 |
) |
Equity in loss from an investment
|
|
|
45,000 |
|
|
|
— |
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
Prepaid expenses and security deposits
|
|
|
44,000 |
|
|
|
453,000 |
|
Accounts payable
|
|
|
129,000 |
|
|
|
(265,000 |
) |
Accrued expenses
|
|
|
(27,000 |
) |
|
|
(226,000 |
) |
Accrued officers’ salaries and payroll taxes
|
|
|
21,000 |
|
|
|
(380,000 |
) |
Accrued dividend
|
|
|
17,000 |
|
|
|
14,000 |
|
Operating lease liability
|
|
|
(94,000 |
) |
|
|
(79,000 |
) |
Net cash used in operating activities
|
|
|
(1,268,000 |
) |
|
|
(4,201,000 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Patent costs
|
|
|
(31,000 |
) |
|
|
(44,000 |
) |
Net cash used in investing activities
|
|
|
(31,000 |
) |
|
|
(44,000 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds from exercise of warrants to purchase Series B-2 5%
convertible preferred stock
|
|
|
— |
|
|
|
4,983,000 |
|
Proceeds from exercise of options
|
|
|
— |
|
|
|
23,000 |
|
Repayment of note payable to officer
|
|
|
(15,000 |
) |
|
|
(1,033,000 |
) |
Dividend paid to Preferred stockholders
|
|
|
(70,000 |
) |
|
|
— |
|
Net cash provided by (used in) financing activities
|
|
|
(85,000 |
) |
|
|
3,973,000 |
|
|
|
|
|
|
|
|
|
|
NET DECREASE IN CASH
|
|
|
(1,384,000 |
) |
|
|
(272,000 |
) |
CASH, BEGINNING OF PERIOD
|
|
|
3,807,000 |
|
|
|
10,194,000 |
|
CASH, END OF PERIOD
|
|
$ |
2,423,000 |
|
|
$ |
9,922,000 |
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURES OF CASH FLOW
INFORMATION
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$ |
29,000 |
|
|
$ |
29,000 |
|
Cash paid for tax
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
NON-CASH INVESTING AND FINANCING ACTIVITY
|
|
|
|
|
|
|
|
|
Surrender of Common Stock Class B by a Stockholder
|
|
$ |
1,000 |
|
|
$ |
— |
|
Conversion of preferred stock to common stock
|
|
$ |
— |
|
|
$ |
3,509,000 |
|
Deferred offering costs
|
|
$ |
59,000 |
|
|
$ |
359,000 |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
INNOVATION PHARMACEUTICALS
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
DECEMBER 31, 2022
(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, 2022, included in our Annual Report on Form 10-K for
the year ended June 30, 2022.
In the opinion of the management of Innovation Pharmaceuticals
Inc., all adjustments, which are of a normal recurring nature,
necessary for a fair statement of the results for the three-month
and six-month periods have been made. Results for the interim
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 the 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 six months ended December 31, 2022 and
2021.
Nature of Operations - Overview
We are in the business of developing or licensing 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 maximize the
value of our drug compound Brilacidin by advancing indications
along the regulatory pathway as well as seeking additional health
care-related investment opportunities with the aim of diversifying
the Company’s assets. Ongoing activities include Brilacidin drug
manufacturing, scientific report writing, and supportive research
activities. The Company also acquired a non-controlling interest in
BT BeaMedical Technologies Ltd. (“BTL”) which formerly known as
Squalus Medical Ltd., a private company developing a novel image
guided surgical laser platform. Management is focused on other
avenues of business development, including, but not limited to,
joint ventures, mergers and acquisitions, strategic investments,
and licensing agreements, for the purpose of diversifying corporate
assets. While no assurances are expressed or implied that any
agreement will be consummated in the future, the Company is
committed toward executing on opportunities at hand.
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.
2. Liquidity, Going Concern and Management’s
Plan
Our financial statements were prepared assuming we will continue as
a going concern which contemplates the realization of assets and
satisfaction of liabilities in the normal course of business. For
the six months ended December 31, 2022, the Company had a net loss
of $1.8 million and negative cash flow from operations of $1.3
million. As of December 31, 2022, the Company has negative working
capital of $2.3 million. As of December 31, 2022, the Company’s
cash amounted to $2.4 million and current liabilities amounted to
$4.8 million. The Company has expended substantial funds on its
clinical trials and expects to continue our spending on research
and development expenditures. We expect to incur further losses in
the development of our business and have been dependent on funding
operations from inception. These conditions raise substantial doubt
about our ability to continue as a going concern. Management’s
plans include continuing to finance operations through the private
or public placement of debt and/or equity securities and the
reduction of expenditures. However, no assurance can be given at
this time as to whether we will be able to achieve these
objectives. The financial statements do not include any adjustment
relating to the recoverability and classification of recorded asset
amounts or the amounts and classification of liabilities that might
be necessary should we be unable to continue as a going
concern.
These factors raise a substantial doubt about the Company’s ability
to continue as a going concern. The accompanying financial
statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets
or the amounts and classifications of liabilities that may result
from the possible inability of the Company to continue as a going
concern.
3. Significant Accounting Policies and Recent Accounting
Pronouncements
Use of
Estimates
The preparation of financial statements in conformity with U.S.
GAAP requires management to make estimates and assumptions that
affect certain reported amounts of assets and liabilities,
disclosure of contingent assets and liabilities at the date of the
financial statements, and the reported amounts of revenues and
expenses during the reporting periods. Significant items subject to
such estimates and assumptions include contract research accruals,
recoverability of long-lived assets, valuation of equity grants and
income tax valuation. The Company bases its estimates on historical
experience and various other assumptions that management believes
to be reasonable under the circumstances. Changes in estimates are
recorded in the period in which they become known. Actual results
could differ from those estimates.
Basic and
Diluted 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, convertible related
party notes payable, and convertible preferred stock. Common share
equivalents were excluded from the computation of diluted earnings
per share for the six months ended December 31, 2022 and 2021,
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:
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
Net loss per share, basic and diluted
|
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding:
|
|
|
|
|
|
|
|
|
Class A common stock
|
|
|
488,284,384 |
|
|
|
436,249,011 |
|
Class B common stock
|
|
|
15,580,009 |
|
|
|
15,641,463 |
|
Total weighted average shares outstanding
|
|
|
503,864,393 |
|
|
|
451,890,474 |
|
|
|
|
|
|
|
|
|
|
Antidilutive securities not included:
|
|
|
|
|
|
|
|
|
Stock options
|
|
|
8,208,269 |
|
|
|
9,878,269 |
|
Stock options arising from convertible note payable and accrued
interest
|
|
|
474,398 |
|
|
|
542,212 |
|
Restricted stock grants
|
|
|
19,463 |
|
|
|
58,392 |
|
Convertible preferred stock
|
|
|
36,000,000 |
|
|
|
9,000,000 |
|
Total
|
|
|
44,702,130 |
|
|
|
19,478,873 |
|
Treasury
Stock
The Company accounts for treasury stock using the cost method. The
10,874,593 treasury shares include 8,516,056 shares of
Class A common stock and 2,358,537 shares of Class B common stock
held in treasury, and they were purchased at a total cumulative
cost of approximately $2.3 million as of as of December 31, 2022
and June 30, 2022 (see Note 15. Equity Transactions).
Treasury stock, representing shares of the Company’s common stock
that have been acquired for payroll tax withholding on vested stock
grants and to satisfy the exercise price on vested stock options,
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,
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 8. Exclusive License Agreement
and Patent Assignment Agreement).
Revenue is recognized when a customer obtains control of promised
goods or services, in an amount that reflects the consideration
which the entity expects to receive in exchange for those goods or
services.
Pursuant to ASC 606, a customer is a party that has contracted with
an entity to obtain goods or services that are an output of the
entity’s ordinary activities in exchange for consideration.
To determine revenue recognition for arrangements that an entity
determines are within the scope of ASC 606, the Company performs
the following five steps:
|
(i)
|
identify the contract(s) with a customer;
|
|
(ii)
|
identify the performance obligations in the contract, including
whether they are distinct in the context of the contract;
|
|
(iii)
|
determine the transaction price, including the constraint on
variable consideration;
|
|
(iv)
|
allocate the transaction price to the performance obligations in
the contract; and
|
|
(v)
|
recognize revenue when (or as) the Company satisfies each
performance obligation.
|
The Company only applies the five-step model to contracts when it
is probable that the entity will collect the consideration it is
entitled to in exchange for the goods or services it transfers to
the customer. At contract inception, once the contract is
determined to be within the scope of ASC 606, the Company assesses
the goods or services promised within each contract and determines
those that are performance obligations, and assesses whether each
promised good or service is distinct. If a promised good or service
is not distinct, it is combined with other performance obligations.
The Company then recognizes as revenue the amount of the
transaction price that is allocated to the respective performance
obligation when (or as) the performance obligation is
satisfied.
The terms of the Company’s licensing agreement include the
following:
|
(i)
|
up-front fees;
|
|
(ii)
|
milestone payments related to the achievement of development,
regulatory, or commercial goals; and
|
|
(iii)
|
royalties on net sales of licensed products.
|
License of Intellectual Property: If the license to the Company’s
intellectual property is determined to be distinct from the other
performance obligations identified in the arrangement, the Company
recognizes revenues from non-refundable, up-front fees allocated to
the license when the license is transferred to the customer and the
customer is able to use and benefit from the license. If not
distinct, the license is combined with other performance
obligations in the contract. For licenses that are combined with
other performance obligations, the Company assesses the nature of
the combined performance obligation to determine whether the
combined performance obligation is satisfied over time or at a
point in time and, if over time, the appropriate method of
measuring progress for purposes of recognizing revenue. The Company
evaluates the measure of progress each reporting period and, if
necessary, adjusts the measure of performance and related revenue
recognition.
Milestone Payments: At the inception of each arrangement that
includes developmental and regulatory milestone payments, the
Company evaluates whether the achievement of each milestone
specifically relates to the Company’s efforts to satisfy a
performance obligation or transfer a distinct good or service
within a performance obligation. If the achievement of a milestone
is considered a direct result of the Company’s efforts to satisfy a
performance obligation or transfer a distinct good or service and
the receipt of the payment is based upon the achievement of the
milestone, the associated milestone value is allocated to that
distinct good or service. If the milestone payment is not
specifically related to the Company’s effort to satisfy a
performance obligation or transfer a distinct good or service, the
amount is allocated to all performance obligations using the
relative standalone selling price method. The Company also
evaluates the milestone to determine whether they are considered
probable of being reached and estimates the amount to be included
in the transaction price using the most likely amount method. If it
is probable that a significant revenue reversal would not occur,
the associated milestone value is included in the transaction price
to be allocated, otherwise, such amounts are constrained and
excluded from the transaction price. At the end of each subsequent
reporting period, the Company re-evaluates the probability of
achievement of such development milestones and any related
constraint, and if necessary, adjusts its estimate of the
transaction price. Any such adjustments to the transaction price
are allocated to the performance obligations on the same basis as
at contract inception. Amounts allocated to a satisfied performance
obligation shall be recognized as revenue, or as a reduction of
revenue, in the period in which the transaction price changes.
Royalties: For arrangements that include sales-based royalties,
including milestone payments based on the level of sales, and the
license is deemed to be the predominant item to which the royalties
relate, the Company will recognize revenue at the later of (i) when
the related sales occur, or (ii) when the performance obligation to
which some or all of the royalty has been allocated has been
satisfied (or partially satisfied) in accordance with the royalty
recognition constraint.
Accounting for
Stock Based Compensation
The stock-based compensation expense incurred by the Company for
employees, non-employees and directors in connection with its
equity incentive plan is based on ASC 718, and the fair market
value of the equity awards 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 is
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. The grant date is
also the valuation date for the non-employee awards. We recognize
stock-based compensation using the straight-line method.
Investments
For those investments in common stock or in-substance common stock
in which the Company has the ability to exercise significant
influence over the operating and financial policies of the
investee, the investment is accounted for under the equity method.
For those investments in which the Company does not have such
significant influence, the Company applies the accounting guidance
for certain investments in debt and equity securities.
4. Equity Investment
BT BeaMedical Technologies Ltd. (formerly known as Squalus Medical
Ltd.)
On June 9, 2022, the Company entered into a Series A Preferred
Share Purchase Agreement (the “Purchase Agreement”) with BT
BeaMedical Technologies Ltd. (formerly known as Squalus Medical
Ltd.), a company established under the laws of the State of Israel
(“BTL”), pursuant to which the Company purchased 55,556 shares of
BTL’s Series A Redeemable Preferred Shares (the “Series A Shares”)
and a warrant to purchase 27,778 Series A Shares for aggregate
consideration of $4,000,000, or approximately $72.00 per Series A
Share. Following the closing under the Purchase Agreement, the
Company owns approximately 35.7% of BTL’s issued and outstanding
equity securities and approximately 41.6% of BTL’s equity
securities on a fully diluted basis. The Company also entered into
customary investor rights and indemnification agreements with BTL.
The Company therefore recorded an equity investment on our December
31, 2022 condensed consolidated balance sheet.
The Company’s equity in losses in excess of its investment are
accounted for under the equity method and consisted of the
following as of December 31, 2022 and June 30, 2022 (rounded in
nearest thousand):
|
|
December 31,
|
|
|
June 30,
|
|
|
|
2022
|
|
|
2022
|
|
BT BeaMedical Technologies Ltd.
|
|
|
|
|
|
|
Ownership Interest
|
|
|
35.7 |
% |
|
|
35.7 |
% |
Carrying Amount
|
|
|
|
|
|
|
|
|
Total contributions
|
|
$ |
4,000,000 |
|
|
$ |
4,000,000 |
|
Less: Share of the loss in investment in BTL
|
|
|
(67,000 |
) |
|
|
(22,000 |
) |
Equity losses in excess of investment
|
|
$ |
3,933,000 |
|
|
$ |
3,978,000 |
|
The Company invested approximately $4,000,000 in BTL in June, 2022.
The cash balance in BTL at December 31, 2022 was approximately $0.5
million. During the six months ended December 31, 2022, BTL
incurred a loss of approximately $126,000, and accordingly, the
Company recorded its share of the loss in investment in BTL, in
accordance with the provisions in the purchase agreement, of
approximately $45,000 in the accompanying condensed consolidated
statement of operations.
Summarized balance sheet information for the Company’s equity
method investee BTL as of December 31, 2022 and June 30, 2022 is
presented in the following table (rounded to nearest thousand):
|
|
December 31,
|
|
|
June 30,
|
|
BT BeaMedical Technologies Ltd.
|
|
2022
|
|
|
2022
|
|
Assets
|
|
|
|
|
|
|
Cash
|
|
$ |
492,000 |
|
|
$ |
3,850,000 |
|
Short term investment
|
|
|
3,123,000 |
|
|
|
— |
|
Other current assets
|
|
|
5,000 |
|
|
|
1,000 |
|
Total current assets
|
|
$ |
3,620,000 |
|
|
$ |
3,851,000 |
|
Long-term assets
|
|
|
154,000 |
|
|
|
— |
|
Total assets
|
|
$ |
3,774,000 |
|
|
$ |
3,851,000 |
|
|
|
|
|
|
|
|
|
|
Liabilities and equity
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
$ |
109,000 |
|
|
$ |
195,000 |
|
Long-term liabilities
|
|
|
101,000 |
|
|
|
— |
|
Total liabilities
|
|
$ |
210,000 |
|
|
$ |
195,000 |
|
Equity
|
|
|
3,769,000 |
|
|
|
3,735,000 |
|
Accumulated deficits
|
|
|
(205,000 |
) |
|
|
(79,000 |
) |
Total liabilities and equity
|
|
$ |
3,774,000 |
|
|
$ |
3,851,000 |
|
Summarized income statement information for the Company’s equity
method investee BTL is presented in the following table for the
period from June 9, 2022 (date of acquisition) to December 31, 2022
(rounded to nearest thousand):
|
|
For the six months ended
December 31,
|
|
|
For the period from June 9, 2022 (date of acquisition)
to
June 30,
|
|
|
|
2022
|
|
|
2022
|
|
Net sales and revenue
|
|
|
13,000 |
|
|
|
— |
|
Research and development costs
|
|
|
125,000 |
|
|
|
7,000 |
|
Administrative expenses
|
|
|
34,000 |
|
|
|
55,000 |
|
Total operating expense
|
|
|
159,000 |
|
|
|
62,000 |
|
Loss from operations
|
|
|
(146,000 |
) |
|
|
(62,000 |
) |
Other income (expense)
|
|
|
20,000 |
|
|
|
1,000 |
|
Net loss
|
|
|
(126,000 |
) |
|
|
(61,000 |
) |
5. Patents, net
Patents, net consisted of the following (rounded to nearest
thousand):
|
|
Useful life
(years)
|
|
|
December 31,
2022
|
|
|
June 30,
2022
|
|
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 - Brilacidin and other compounds
|
|
|
17
|
|
|
|
1,177,000 |
|
|
|
1,146,000 |
|
Total patents cost
|
|
|
|
|
|
|
5,403,000 |
|
|
|
5,372,000 |
|
Less: Accumulated amortization
|
|
|
|
|
|
|
(3,247,000 |
) |
|
|
(3,060,000 |
) |
Patents, net
|
|
|
|
|
|
$ |
2,156,000 |
|
|
$ |
2,312,000 |
|
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 December 31, 2022
and 2021 was approximately $94,000 and $96,000, respectively and
was approximately $187,000 and $191,000 for the six months ended
December 31, 2022 and 2021, respectively. The Company wrote off the
patent costs relating to Kevetrin of approximately $141,000 during
the fourth quarter of 2022 due to discontinuation of its Kevetrin
program.
At December 31, 2022, the future amortization period for all
patents was approximately 2.68 years to 16.75 years. Future
estimated amortization expenses are approximately $186,000 for the
year ending June 30, 2023, $372,000 for each year from 2024 to
2025, $362,000 for the year ending June 30, 2026, $360,000 for the
year ending June 30, 2027 and a total of $504,000 for the year
ending June 30, 2028 and thereafter.
6. Accrued Expenses - Related Parties and
Other
Accrued expenses consisted of the following (rounded to nearest
thousand):
|
|
December 31,
2022
|
|
|
June 30,
2022
|
|
|
|
|
|
|
|
|
Accrued research and development consulting fees
|
|
$ |
50,000 |
|
|
$ |
80,000 |
|
Accrued rent - related parties (Note 11. Related Party
Transactions)
|
|
|
8,000 |
|
|
|
8,000 |
|
Accrued interest - related parties (Note 12. Convertible Note
Payable - Related Party)
|
|
|
7,000 |
|
|
|
4,000 |
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
65,000 |
|
|
$ |
92,000 |
|
7. Accrued Salaries and Payroll Taxes - Related Parties and
Other
Accrued salaries and payroll taxes consisted of the following
(rounded to nearest thousand):
|
|
December 31,
2022
|
|
|
June 30,
2022
|
|
|
|
|
|
|
|
|
Accrued salaries - related parties
|
|
$ |
1,517,000 |
|
|
$ |
1,492,000 |
|
Accrued payroll taxes - related parties
|
|
|
71,000 |
|
|
|
71,000 |
|
Withholding tax - payroll
|
|
|
73,000 |
|
|
|
77,000 |
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
1,661,000 |
|
|
$ |
1,640,000 |
|
8. Exclusive License Agreement and Patent Assignment
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
received an initial upfront non-refundable payment of $0.4 million
and reported as revenue in July, 2019 and the Company did not
receive any further payment during the six months ended December
31, 2022 and 2021.
On April 13, 2022, the Company entered a Patent Assignment
Agreement with Fox Chase Chemical Diversity Center, Inc. (“FCCDC”),
pursuant to which the Company assigned the title, rights and
interest in and to the applications of certain patents in
accordance with an earlier collaborative research agreement related
to antifungal drug discovery work to which the Company had
rights.
On May 3, 2022, the Company received payment of $18,000 from FCCDC
based on FCCDC’s third-party license of broad-spectrum anti-fungals
and a separate agreement between the Company and FCCDC. Some of the
preliminary data used in the FCCDC research program had been
obtained as part of an earlier collaboration with the Company
supported by funding from the National Institutes of Health.
On January 18, 2023, the Company was notified by FCCDC that its
third-party license with Basilea Pharmaceutica for development of
broad-spectrum antifungals was terminated by the licensee.
9. 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 10. Commitments and Contingencies).
The components of lease expense and supplemental cash flow
information related to leases for the period are as follows:
|
|
Six Months
Ended
December 31,
2022
|
|
Lease Cost
|
|
|
|
Operating lease cost (included in general and administrative in the
Company’s condensed consolidated statements of operations)
|
|
$ |
18,000 |
|
Variable lease cost
|
|
|
6,000 |
|
|
|
$ |
24,000 |
|
Other Information
|
|
|
|
|
Cash paid for amounts included in the measurement of lease
liabilities for the six months ended December 31, 2022
|
|
$ |
118,000 |
|
Weighted average remaining lease term - operating leases (in
years)
|
|
|
0.75 |
|
Average discount rate - operating leases
|
|
|
18 |
% |
The supplemental balance sheet information related to leases for
the period is as follows:
|
|
At
December 31,
2022
|
|
Operating leases
|
|
|
|
Short-term operating lease liabilities
|
|
$ |
158,000 |
|
Long-term operating lease liabilities
|
|
|
- |
|
|
|
|
|
|
Total operating lease liabilities
|
|
$ |
158,000 |
|
The following table provides maturities of the Company’s lease
liabilities at December 31, 2022 as follows:
|
|
Operating
Leases
|
|
Fiscal Year Ending June 30,
|
|
|
|
2023
|
|
$ |
112,000 |
|
2024 (remaining 3 months)
|
|
|
56,000 |
|
Total lease payments
|
|
|
168,000 |
|
Less: Imputed interest/present value discount
|
|
|
(10,000 |
) |
Present value of lease liabilities
|
|
$ |
158,000 |
|
Operating lease cost for the three months and the six months ended
December 31, 2022 was approximately $11,000 and $24,000,
respectively. Operating lease cost for the three months and the six
months ended December 31, 2021 was approximately $17,000 and
$39,000, respectively.
10. 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 terminated in September 2018,
because 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
total lease amount is approximately $0.6 million. 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 $0.7 million to contract research
organizations as of December 31, 2022. Expenses are recognized when
services are performed by the contract research organizations.
Contingent
Liability - Disputed Invoices
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 (see Note 7. Accrued Salaries and Payroll Taxes). As
described in Note 11. 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.
As of December 31, 2022 and June 30, 2022, all of the above
disputed invoices were reflected as current liabilities.
11. 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 to conduct research study. At
December 31, 2022 and June 30, 2022, the accrued research and
development expenses payable to KARD was approximately $1,486,000
and this amount was included in accounts payable. Dr. Menon, the
Company’s ex-principal shareholder and Director, 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.
Since September 1, 2013, the Company no longer leases space from
KARD. As of December 31, 2022 and June 30, 2022, rent payables to
KARD of approximately $8,000, were included in accrued
expenses.
12. 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 18,000,000 Equity
Incentive Options to purchase Class B common stock 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. All these options were valid for ten
years from the date of issuance and expired in May, 2022.
During the six months ended December 31, 2022 and for year ended
June 30, 2022, the Company repaid the principal of $15,000 and
$1,033,000, respectively to Mr. Ehrlich. As of December 31, 2022
and June 30, 2022, the principal balance of this convertible note
payable to Mr. Ehrlich was approximately $235,000 and $250,000,
respectively.
As of December 31, 2022 and June 30, 2022, the balance of accrued
interest payable was $2,000 and $4,000, respectively (see Note 6.
Accrued Expenses - Related Parties and Other).
As of December 31, 2022 and June 30, 2022, the total outstanding
balances of principal and interest were approximately $237,000 and
$254,000, respectively.
13. 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.
In December, 2021, the Company obtained the approval of the
forgiveness of the above mentioned two loans, and the Company
recorded the total loan forgiveness of $172,000 under other income
during the six months ended December 31, 2021.
14. 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.
On October 10, 2021, the Board of Directors approved amendments to
the 2016 Plan to increase the number of shares of common stock
available for issuance thereunder to 225,000,000 shares and to
increase the annual limit on the number of awards under such Plan
to outside directors from 1,500,000 to 5,000,000, among other
changes.
Up to 225,000,000 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 during the six months ended
December 31, 2021 was estimated on the date of grant using the
Black-Scholes-Merton Model that uses assumptions noted in the
following table. There was no option grant during the six months
ended December 31, 2022.
|
|
Six months Ended December 31,
2021
|
|
Expected term (in years)
|
|
5-10
|
|
Expected stock price volatility
|
|
80.84 to 89.51
|
%
|
Expected term (in years)
|
|
0.69% to 1.61
|
|
Expected dividend yield
|
|
|
— |
|
The components of stock-based compensation expense included in the
Company’s Statements of Operations for the three months and six
months ended December 31, 2022 and 2021 are as follows (rounded to
nearest thousand):
|
|
Three months ended
December 31
|
|
|
Six months ended
December 31
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses
|
|
$ |
14,000 |
|
|
$ |
111,000 |
|
|
$ |
161,000 |
|
|
$ |
111,000 |
|
Research and development expenses
|
|
|
7,000 |
|
|
|
41,000 |
|
|
|
38,000 |
|
|
|
81,000 |
|
Total stock-based compensation expense
|
|
$ |
21,000 |
|
|
$ |
152,000 |
|
|
$ |
199,000 |
|
|
$ |
192,000 |
|
During the six months ended December 31, 2022 and
2021
Directors and
Employee
On October 10, 2021, the Compensation Committee approved the
issuance of 1 million stock options to purchase shares of the
Company’s common stock each to 2 independent directors of the
Company, and 1 million stock options to purchase shares of
Company’s common stock to Mr. Ehrlich, the CEO, which are
exercisable for 10 years at $0.24 per share of common stock. These
3 million stock options with 1 year vesting period were valued at
approximately $585,000. During the six months ended December 31,
2022 and 2021, the Company recorded approximately $161,000 and
$111,000 of stock-based compensation costs, respectively. The
assumptions used in the Black-Scholes-Merton option-pricing model
are disclosed above.
On October 10, 2021, the Company also issued to Ms. Jane Harness,
the Senior Vice President, Clinical Sciences and Portfolio
Management of the Company, 500,000 options to purchase common
stock, which are exercisable for 10 years at $0.24 per share of
common stock. These stock options with 1 year vesting period were
valued at approximately $98,000. During the six months ended
December 31, 2022 and 2021, the Company recorded approximately
$27,000 and $22,000 of related stock-based compensation cost,
respectively. The assumptions used in the Black-Scholes-Merton
option-pricing model are disclosed above.
On September 11, 2020, the Company 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 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 six
months ended December 31, 2022, the Company recorded approximately
$8,000 of stock-based compensation expense in connection with the
foregoing equity awards, including approximately $6,000 of stock
option expense and $2,000 of stock awards. During the six months
ended December 31, 2021, the Company recorded approximately $8,000
of stock-based compensation expense in connection with the
foregoing equity awards, including approximately $6,000 of stock
option expense and $2,000 of stock awards.
On September 1, 2019, the Company 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 with
a 3 year 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 six months ended December 31, 2022,
the Company recorded approximately $1,000 of stock-based
compensation expense in connection with the foregoing equity
awards, including approximately $1,000 of stock option expense.
During the six months ended December 31, 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.
On September 1, 2018, the Company 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 six months ended December 31, 2022, the Company recorded no
stock-based compensation expense in connection with the foregoing
equity awards. During the six months ended December 31, 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.
Consultants
On January 1, 2022, the Company agreed to issue stock options to
purchase 75,000 shares of the Company’s common stock to one
consultant for his one-year contract. These options were issued
with an exercise price of $0.044 per share and vest 33 1/3% on
January 1, 2022, 33 1/3% on July 1, 2022 and 33 1/3% on January 1,
2023. The value of these options was approximately $3,000. During
the six months ended December 31, 2022, the Company recorded
approximately $2,000 of related stock-based compensation. The
assumptions used in the Black-Scholes-Merton option-pricing model
are disclosed above.
On July 30, 2021, the Company agreed to issue stock options to
purchase 100,000 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 six months ended December 31, 2022 and 2021, the Company
recorded approximately $1,000 and $11,000 of related stock-based
compensation, respectively. The assumptions used in the
Black-Scholes-Merton option-pricing model are disclosed above.
On July 1, 2021, the Company agreed to issue stock options to
purchase 225,000 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
six months ended December 31, 2022 and 2021, the Company recorded
$0 and approximately $22,000 of related stock-based compensation,
respectively. The assumptions used in the Black-Scholes-Merton
option-pricing model are disclosed above.
On February 10, 2021, the Company agreed to issue stock options to
purchase 75,000 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 six months ended December 31, 2022 and 2021, the Company
recorded $0 and approximately $7,000 of related stock-based
compensation, respectively. The assumptions used in the
Black-Scholes-Merton option-pricing model are disclosed above.
On July 23, 2020, the Company agreed to issue stock options to
purchase 100,000 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 six months ended December 31, 2022 and 2021, the Company
recorded $0 and approximately $1,000 of related stock-based
compensation, respectively. The assumptions used in the
Black-Scholes-Merton option-pricing model are disclosed above.
Exercise of options
There was no exercise of options to purchase Class B common stock
during the six months ended December 31, 2022 and December 31,
2021.
Forfeiture of options
There was forfeiture of 60,000 options and 2,245,000 options to
purchase Class A common stock during the six months ended December
31, 2022 and the year ended June 30, 2022, respectively, relating
to the expiry of options of an officer and 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, 2021
|
|
|
6,779,935 |
|
|
$ |
0.35 |
|
|
|
4.45 |
|
|
$ |
345,923 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
3,900,000 |
|
|
$ |
0.24 |
|
|
|
8.75 |
|
|
|
— |
|
Exercised
|
|
|
(166,666 |
) |
|
$ |
0.14 |
|
|
|
— |
|
|
|
— |
|
Forfeited/expired
|
|
|
(2,245,000 |
) |
|
$ |
0.54 |
|
|
|
— |
|
|
|
— |
|
Outstanding at June 30, 2022
|
|
|
8,268,269 |
|
|
$ |
0.25 |
|
|
|
6.91 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
|
— |
|
Exercised
|
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
|
— |
|
Forfeited/expired
|
|
|
(60,000 |
) |
|
$ |
0.96 |
|
|
|
— |
|
|
|
— |
|
Outstanding at December 31, 2022
|
|
|
8,208,269 |
|
|
$ |
0.24 |
|
|
|
6.46 |
|
|
$ |
— |
|
Exercisable at December 31, 2022
|
|
|
8,125,607 |
|
|
$ |
0.24 |
|
|
|
6.45 |
|
|
$ |
— |
|
Unvested stock options at December 31, 2022
|
|
|
82,662 |
|
|
$ |
0.17 |
|
|
|
6.58 |
|
|
$ |
— |
|
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, 2021
|
|
|
116,786 |
|
|
$ |
0.22 |
|
|
|
|
|
|
|
|
|
|
Total shares granted
|
|
|
— |
|
|
$ |
— |
|
Total shares vested
|
|
|
(58,394 |
) |
|
$ |
0.25 |
|
Total shares forfeited
|
|
|
— |
|
|
$ |
— |
|
Total unvested shares outstanding at June 30, 2022
|
|
|
58,392 |
|
|
$ |
0.19 |
|
|
|
|
|
|
|
|
|
|
Total shares granted
|
|
|
— |
|
|
$ |
— |
|
Total shares vested
|
|
|
(38,929 |
) |
|
$ |
0.18 |
|
Total shares forfeited
|
|
|
— |
|
|
$ |
— |
|
Total unvested shares outstanding at December 31, 2022
|
|
|
19,463 |
|
|
$ |
0.22 |
|
Scheduled vesting for outstanding restricted stock awards at
December 31, 2022 is as follows:
|
|
Year Ending June 30,
|
|
|
|
2023
|
|
|
2024
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
Scheduled vesting
|
|
|
— |
|
|
|
19,463 |
|
|
|
19,463 |
|
As of December 31, 2022, there was approximately $3,000 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
$3,000 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 0.70 years.
15. Equity Transactions
$30 million Class A
Common Stock Purchase Agreement with Aspire
Capital
On July 31, 2020, the Company entered into the 2020 Stock Purchase
Agreement (the “2020 Purchase 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
Agreement. In consideration for entering into the 2020 Purchase
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 Purchase Agreement. The amortized amount
of approximately $0.6 million and $0.2 million was recorded to
additional paid-in capital for the six months ended December 31,
2022 and 2021. All deferred offering costs were fully amortized on
July 31, 2022 (date of expiration of the agreement).
During the period from July 1, 2022 to July 31, 2022 (date of
expiration of the agreement), the Company did not sell any shares
to Aspire Capital. During the period from July 31, 2020 to June 30,
2022, the Company generated proceeds of approximately $4.6 million
under the 2020 Purchase Agreement with Aspire Capital from the sale
of approximately 22.5 million shares of its common stock.
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 under additional paid in capital,
based on a relative fair value allocation of proceeds, that is the
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.
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 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 on December 11,
2020.
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.
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 $9,000 and $14,000
were treated as interest during the quarter ended December 31, 2022
and 2021, respectively, in the Condensed Consolidated Statements of
Operations. The total dividends accrued of approximately $17,000
and $14,000 were treated as interest during the six months ended
December 31, 2022 and 2021, respectively, in the Condensed
Consolidated Statements of Operations. The change in fair value of
the total Series B-2 preferred stock were $0 during the quarter
ended December 31, 2022 and 2021 in the Condensed Consolidated
Statements of Operations.
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 $1,080 and may be converted at any time at the holder’s
option into shares of the Company’s common stock at a conversion
price equal of the lower of (i) $0.35 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.
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 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 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 six months ended December 31, 2022, there was no
exercise of warrants because all warrants were exercised since
November 4, 2021.
During the six months ended December 31, 2021, the Company issued
3,036 shares of its Series B-2 5% convertible preferred stock, for
aggregate gross proceeds of approximately $3.0 million, 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 $3.0 million to the
preferred stock liability. As of December 31, 2022 and June 30,
2022, there was no warrant outstanding.
Conversion of 2020 Series B-2 5% convertible preferred
stock to common stock
During the six months ended December 31, 2022, there was no
conversion of 2020 Series B-2 5% convertible preferred stock to
common stock.
During the six months ended December 31, 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 approximately
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 $3.0 million as
Additional paid-in capital at par value. The Company reversed the
amount of approximately $3.0 million based on the proportion of
Series B-2 5% convertible preferred stock converted relative to the
original total issued.
As of December 31, 2022 and June 30, 2022, Series B-2 5%
convertible preferred stock liability was approximately $0.8
million.
The fair value of the Series B convertible preferred stock is
measured in accordance with ASC 820 “Fair Value Measurement,” using
option pricing methodologies, incorporating the following
inputs:
|
|
June 30,
2022
|
|
|
|
|
|
Expected dividend yield
|
|
|
5 |
% |
Expected stock-price volatility
|
|
|
60 |
% |
Risk-free interest rate
|
|
|
2.92 |
% |
Stock price
|
|
$ |
0.03 |
|
Exercise price
|
|
$ |
982.5 |
|
Treasury
Stock
All treasury stock, representing shares of the Company’s common
stock that have been acquired for payroll tax withholding on vested
stock grants and to satisfy the exercise price on vested stock
options, is recorded at its acquisition cost and these shares are
not considered outstanding.
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 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 with a
fair value of $1,438,000 to satisfy the exercise price. The Company
withheld 1,765,203 shares of Class B common stock and cancelled an
additional 854,419 shares of Class A common stock held by Mr.
Ehrlich to satisfy tax withholding obligations. 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 tax
withholding obligations), 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.
Following the aforesaid transactions, the Company had the total of
10,874,593 treasury shares, representing 8,516,056 shares of Class
A common stock and 2,358,537 shares of Class B common stock held in
treasury, and they were purchased at a total cumulative cost of
approximately $2.3 million as of as of December 31, 2022 and June
30, 2022.
Surrender of
Shares
On December 29, 2022, Mr. Ehrlich entered into a Share Surrender
Agreement with the Company pursuant to which Mr. Ehrlich
permanently surrendered all legal right, title, and interest in
11,307,527 shares of Class B common stock to the Company and
relinquished all rights in such shares, free and clear of any
liens, mortgages, adverse claims, charges, security interests,
encumbrances, any interest of any third party, or other
restrictions or limitations whatsoever of any kind. Mr. Ehrlich
received no consideration from the Company or any other party in
connection with the surrender. Mr. Ehrlich effected the Surrender
solely for his individual tax planning purposes. These
11,307,527 shares of Class B common stock were retired and returned
to Class B common stock on the same day.
16. Fair Value Measurements
We disclose and recognize the fair value of our assets and
liabilities using a hierarchy that prioritizes the inputs to
valuation techniques used to measure fair value. Fair value is
defined as the price that would be received to sell an asset or
paid to transfer a liability (an exit price) in an orderly
transaction between market participants at the measurement date.
The guidance establishes three levels of the fair value hierarchy
as follows:
Level 1: Inputs are unadjusted, quoted prices in active
markets for identical assets or liabilities at the measurement
date;
Level 2: Inputs are observable, unadjusted quoted prices
in active markets for similar assets or liabilities, unadjusted
quoted prices for identical or similar assets or liabilities in
markets that are not active, or other inputs that are observable or
can be corroborated by observable market data for substantially the
full term of the related assets or liabilities; and
Level 3: Unobservable inputs that are significant to the
measurement of the fair value of the assets or liabilities that are
supported by little or no market data.
Our financial instruments consist of cash and cash equivalents,
short-term and long-term investments, accounts payable, accrued
liabilities and preferred stock liability. At December 31, 2022 and
2021, the carrying values of cash and cash equivalents, accounts
payable, and accrued liabilities approximated fair value due to
their short-term maturities.
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.
The table below sets forth a reconciliation of the Company’s
beginning and ending Level 3 Series B-2 preferred stock liability
balance for the quarter ended December 31, 2022 and for the year
ended June 30, 2022:
|
|
FY 2022
|
|
Balance, June 30, 2021
|
|
$ |
— |
|
Exercise of Series 1 and 2 warrants
|
|
|
4,983,000 |
|
Conversion of Series B-2 preferred stock to common stock
|
|
|
(4,374,000 |
) |
Change in fair value of Series B-2 preferred stock (1)
|
|
|
177,000 |
|
Balance, June 30, 2022
|
|
$ |
786,000 |
|
|
|
|
|
|
Change in fair value of Series B-2 preferred stock (1)
|
|
|
— |
|
Balance, December 31, 2022
|
|
$ |
786,000 |
|
(1)
|
Change in fair value of preferred stock is reported in interest
expense-preferred stock.
|
(2)
|
The 5% accrued dividend is reported in interest expense-preferred
stock in the condensed consolidated statements of operation. The
Company accrued 5% accrued dividend of $17,000 and $14,000 during
the six months ended December 31, 2022 and June 30, 2022,
respectively. The remaining accrued dividends of $9,000 and $62,000
was included under current liability as of December 31, 2022 and
June 30, 2022, respectively.
|
17. Subsequent Events
The Company has evaluated events subsequent to December 31, 2022
through the issuance of these financial statements and determined
that there were no additional events requiring disclosure.
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 elsewhere in this Form
10-Q and with our Annual Report on Form 10-K for the year ended
June 30, 2022. 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’s lead drug candidate Brilacidin is in a class of compounds
called defensin-mimetics, small compounds that mimic the structure
and function of defensins, also known as host defense peptides. The
Company’s efforts are primarily focused on advancement of
Brilacidin in Oral Mucositis and in infectious diseases. Ongoing
activities include Brilacidin drug manufacturing, scientific report
writing, and supportive research activities. The Company also
acquired an interest in BT BeaMedical Technologies Ltd. (“BTL”),
which is formerly known as Squalus Medical Ltd., a private company
developing a novel image guided surgical laser platform. Management
is focused on other avenues of business development, including, but
not limited to, joint ventures, mergers and acquisitions, strategic
investments, and licensing agreements, for the purpose of
diversifying corporate assets, although there can be no assurances
that any agreement will be consummated in the future.
Recent Developments
As of the date of this filing, Brilacidin is being studied by
independent researchers funded by US Government grants, as a
potential broad-spectrum antiviral therapeutic for the treatment of
viruses. Additionally, the antifungal properties of Brilacidin are
being studied by several academic groups, including
NIH/NIAID-affiliated researchers. We anticipate these studies to
continue as long as researchers remain positive about the antiviral
and antifungal properties and therapeutic potential of Brilacidin
and government funding is available.
On November 15, 2022, the Company announced a scientific poster on
the antiviral activity of Brilacidin was accepted for presentation
at the 2022 Chemical and Biological Defense Science &
Technology Conference. Data generated in alphaviruses and
bunyaviruses showed that Brilacidin possesses both antiviral and
anti-inflammatory properties, reinforcing its potential as a
broad-spectrum antiviral.
On November 28, 2022, the Company announced BT BeaMedical
Technologies (“BTL”), a company in which it maintains a minority
stake, received FDA clearance for its surgical laser family. The
BTL technology was cleared by the FDA in five different wavelengths
and for soft tissue use in a number of clinical specialties.
On December 13, 2022, the Company reported new in vivo
antifungal data showing Brilacidin’s potential for treating fungal
keratitis. In an A. fumigatus mouse model, compared to control,
Brilacidin reduced fungal burden and disease severity, while also
improving corneal thickness.
On January 9, 2023, the Company announced BTL and Shina Systems
Ltd., a company specializing in medical imaging software platforms,
entered into a definitive strategic agreement. The agreement is
intended to accelerate the development, regulatory clearance and
commercial deployment of BTL laser technology for brain
surgery.
In January 2023, the Company was notified by the United States
Patent and Trademark Office (USPTO) that its US Patent Application
16/991812 – Host Defense Protein (HDP) Mimetics for Prophylaxis
And/Or Treatment of Inflammatory Bowel Diseases of the
Gastrointestinal Tract is allowed for issuance as a patent; Notice
of Allowance was issued by USPTO on January 25, 2023.
In January 2023, the Company and University of São Paulo (USP),
Brazil, entered into a collaborative research agreement related to
investigating the broad-spectrum activity and treatment potential
of Brilacidin in fungal diseases. Under terms of the agreement, USP
researchers are to conduct pre-clinical efficacy, mechanism,
resistance and immunological studies of Brilacidin against
Aspergillosis, Cryptococcus and Candida,
with USP eligible to receive future royalties should Brilacidin
eventually be marketed as an antifungal.
Business Development and Licensing
The Company is actively engaged in business development and
licensing initiatives with specialty and global pharmaceutical
companies. The Company may also seek to enter into agreements with
other third-party entities for research, development, and
commercialization of other types of technologies or products. The
goal of these efforts is to diversify and add value to the
Company’s assets. 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. Phase 1 studies in healthy volunteers using Brilacidin
in a proprietary Alfasigma formulation have successfully completed.
In late September 2022, Alfasigma notified the Company that a
revised clinical development plan for UP/UPS, incorporating
regulatory authority feedback, is being enacted. Alteration to
treatment duration requires further preclinical research, and the
Company has been advised by Alfasigma that a Phase 2 multinational
clinical trial conduct is estimated to start in 2H2023. Brilacidin
drug substance is manufactured under direction of the Company as
part of the licensing agreement with Alfasigma. 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. There can be no assurance that Alfasigma
will meet their estimated timeline.
The Company and Fox Chase Chemical Diversity Center, Inc. (“FCCDC”)
have a collaborative research agreement related to an antifungal
drug discovery program. In exchange for a six percent fee
tied to all potential future proceeds, the Company granted FCCDC
all discovery, intellectual property and commercialization rights
related to its share of this joint antifungal drug program which is
for a compound other than Brilacidin. On May 3, 2022, the Company
received payment of $18,000 from FCCDC based on FCCDC’s third-party
license of this compound. Subsequently, this third party license
was terminated in January 2023.
Development Programs
Compound
|
Target/Indication
|
Clinical Status
|
Brilacidin
|
Oral Mucositis (OM)
|
Phase 2 Study (completed)
Phase 3 planned, contingent upon sufficient funding
|
|
Inflammatory Bowel Disease (IBD)
|
Phase 2 UP/UPS Proof of Concept Study (completed)
Phase 1 Safety/toleration/PK of oral dosage form (completed)
|
|
ABSSSI (Acute Bacterial Skin and Skin Structure Infection)
|
Phase 2 (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 Brilacidin.
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. Advancement of our Brilacidin
clinical programs is dependent on securing sufficient working
capital.
The Company devotes most of its efforts and resources on
Brilacidin. 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 through the date of this
Quarterly Report on Form 10-Q:
Brilacidin
COVID-19 (SARS-CoV-2), Additional
Viruses
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 (NCT04784897) of Brilacidin in
moderate-to-severe hospitalized patients with COVID-19. Similar
regulatory approval was obtained from the Russian Ministry of
Health. This Phase 2 clinical trial of intravenously-administered
Brilacidin (3- and 5-day dosing) for COVID-19 conducted at sites in
the United States and Russia has since completed (n=120). While the
trial’s primary endpoint of time to sustained recovery through Day
29 was not met, patients who started study treatment within fewer
than 7 days of
onset of COVID-19 symptoms achieved sustained recovery more quickly
(Brilacidin 5-dose group versus pooled placebo, p=0.03). Other
beneficial treatment effects based on the trial’s primary endpoint
of sustained recovery were also observed in subgroups of patients
with the highest (upper quartile) baseline values for key COVID-19
biomarkers. On two secondary endpoints, more patients treated with
Brilacidin (5-dose group) achieved clinical improvement by 10 days
as measured by National Emergency Warning Score 2 (NEWS2) criteria,
and the mean change from baseline in NEWS2 was greater for
Brilacidin treatment groups at all assessment timepoints.
Additionally, under compassionate use of Brilacidin in critical
cases of COVID-19, where Brilacidin was administered more
frequently and over a longer duration than in the Phase 2 trial,
investigators reported positive changes to subject status. Pursing
a biomarker-driven approach, increasing Brilacidin dosing,
targeting different patient populations, testing Brilacidin in
combination with other drugs (e.g., remdesivir, given synergistic
in vitro data) -- all are areas under consideration for
potential future Brilacidin COVID-19 clinical trials pending
obtaining government, partnership-based or other financial support.
Antiviral data on Brilacidin in non-SARS-CoV-2 viruses has been
generated and presented at scientific conferences. Results from the
Brilacidin COVID-19 clinical trial, as well as findings from in
vitro testing of Brilacidin in multiple viruses, are being
prepared for publication.
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. Phase 1 studies in healthy volunteers using Brilacidin in a
proprietary Alfasigma formulation have successfully completed, and
Alfasigma notified the Company in late September 2022 that a Phase
2 multinational clinical trial is estimated to start in 2H2023.
There can be no assurance that Alfasigma will meet their estimated
timeline.
IBD, Ulcerative Colitis (UC) - Brilacidin
has also been 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, although further work has since been halted due to
instability of that formulation being identified. Hence, further
advancement in the indication of ulcerative colitis requires
conduct of additional formulation development work prior to Phase 1
testing of that oral formulation. Completion of
formulation/analytical development work, clinical trial supply
manufacturing, and subsequent progression into clinical trials, are
pending securing sufficient drug supply and working capital.
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
(administered three times daily as an oral rinse) markedly reduced
the rate of severe OM (WHO Grade ≥ 3), delayed onset of severe OM
and decreased duration of 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.
An optimized oral rinse formulation has been developed, and
12-month stability testing shows it to be stable. Further
advancement in the indication of oral mucositis requires additional
drug formulation/analytical work, followed by clinical trial supply
manufacturing prior to progressing to Phase 3 clinical trials.
Given the low price per share of our common stock and the many
multiple million dollar costs associated with a Phase 3 program, at
this time clinical trial supply manufacturing and Phase 3 clinical
trial conduct are delayed, with such activities pending securing
sufficient working capital and/or partnership.
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.
Antifungal
- Recent data generated from
independent researchers suggest Brilacidin has potential to be
developed as a novel antifungal agent. Brilacidin converted
caspofungin from a fungistatic into a fungicidal drug, enabling it
to overcome both drug resistance and biofilm formation. Brilacidin
exerted, to a lesser degree, synergistic effects with voriconazole
in A. fumigatus. Further in vitro testing showed
Brilacidin synergized with caspofungin in C. albicans, C. auris and
C. neoformans. In an A. fumigatus immunosuppressed mouse model in
invasive pulmonary aspergillosis, Brilacidin plus caspofungin
cleared infection in the lungs by almost 95 percent, compared to
~50 percent when each compound was administered individually. In an
A. fumigatus mouse model in keratitis, compared to control,
Brilacidin reduced fungal burden and disease severity, while also
improving corneal thickness. Brilacidin also showed in
vitro an additive inhibitory effect when combined with
posaconazole in several species of Mucorales, the main etiological
agents of mucormycosis, commonly referred to as black fungus.
Brilacidin further showed potent in vitro stand-alone
efficacy in C. neoformans, a major driver of illness in people
living with HIV/AIDS. Additional Minimum Inhibitory Concentration
(MIC) in vitro testing via a third-party vendor has shown
promising Brilacidin activity in other hard-to-treat fungal
pathogens.
Expenditures on Brilacidin were $0.3 million and $2.4 million
during the six months ended December 31, 2022 and 2021,
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.
Management’s Plan of Operation
The Company historically devoted most of its efforts and resources
on drug development, regulatory matters, and clinical trials.
Presently, the Company does not have sufficient financial resources
to advance our drug candidates meaningfully. Contingent upon
sufficient funding, we anticipate that our efforts would primarily
focus on advancement of our drug candidate
Brilacidin for decreasing the incidence of severe
oral mucositis as a complication of chemoradiation in Oral
Mucositis. The antiviral and antifungal properties of Brilacidin
also present potential clinical development opportunities going
forward should sufficient funding be obtained via grants and/or
pharmaceutical company partnerships. In general, 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 compound(s)/ indications and
enter into partnering, joint development or similar arrangements
with other companies. We may 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.
The Company is monitoring BTL’s progress in advancing its novel
laser-based thermal ablation technology platform targeting epilepsy
and oncology procedures. BTL will use the FDA 510(k) pathway to
achieve its goal of marketing approval in the United States. BTL
recently received certification of ISO13485 for their new facility.
ISO 13485 is the medical industry's medical device standard, which
is designed to ensure that all medical devices meet the proper
regulatory compliance laws and customer needs.
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
See Note 3. Significant Accounting Policies and Recent Accounting
Pronouncements to the condensed consolidated financial statements,
for a discussion of recent accounting pronouncements and their
effect, if any, on our financial statements.
Results of
Operations
We expect to incur losses from operations for the next few years.
Contingent upon sufficient funding, 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 $2.0 million for the next 12 months, including
approximately $0.8 million for development activities, supportive
research, and drug manufacturing. However, continuing operations
for the next 12 months from the date of this filing is very much
dependent upon our ability to raise capital from existing or new
financing sources. There can be no assurance as to the availability
or terms upon which such financing and capital might be
available.
For the three months ended December 31, 2022 and
2021
Revenue
We generated no revenue and incurred operating expenses of
approximately $0.3 million and $2.0 million for the three months
ended December 31, 2022 and 2021, 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
|
|
|
|
December 31,
|
|
|
2022 vs. 2021
|
|
|
|
2022
|
|
|
2021
|
|
|
$
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical studies and development research
|
|
$ |
168,000 |
|
|
$ |
1,170,000 |
|
|
$ |
(1,002,000 |
) |
|
|
(86 |
)% |
Refunds of unused project deposits
|
|
|
(175,000 |
) |
|
|
— |
|
|
|
(175,000 |
) |
|
|
—
|
%
|
Reimbursement for Brilacidin manufacturing expenses
|
|
|
(238,000 |
) |
|
|
— |
|
|
|
(238,000 |
) |
|
|
—
|
%
|
Employees payroll and payroll tax expenses related to R&D
Department
|
|
|
112,000 |
|
|
|
263,000 |
|
|
|
(151,000 |
) |
|
|
(57 |
)% |
Stock-based compensation - employee
|
|
|
7,000 |
|
|
|
29,000 |
|
|
|
(22,000 |
) |
|
|
(76 |
)% |
Stock-based compensation - consultants
|
|
|
— |
|
|
|
12,000 |
|
|
|
(12,000 |
) |
|
|
(100 |
)% |
Depreciation and amortization expenses
|
|
|
93,000 |
|
|
|
119,000 |
|
|
|
(26,000 |
) |
|
|
(22 |
)% |
Total
|
|
$ |
(33,000 |
) |
|
$ |
1,593,000 |
|
|
$ |
(1,626,000 |
) |
|
|
(102 |
)% |
Research and development expenses for proprietary programs
decreased during the three months ended December 31, 2022 compared
with the three months ended December 31, 2021, primarily due to
less spending on our Brilacidin program, increase in refunds of
unused project deposits of $175,000, and increase in reimbursement
for Brilacidin manufacturing expenses of $238,000 for the
three months ended December 31, 2022.
Employees payroll and payroll tax expenses decreased during the
three months ended December 31, 2022 due to no bonus paid during
the three months ended December 31, 2022 compared with the three
months ended December 31, 2021.
Stock-based compensation for employees decreased during the three
months ended December 31, 2022 due to no new issuance of stock
options during the three months ended December 31, 2022 compared
with the three months ended December 31, 2021.
Stock-based compensation – consultants decreased during the three
months ended December 31, 2022 due to no new issuance of stock
options during the three months ended December 31, 2022 compared
with the three months ended December 31, 2021.
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.
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
|
|
|
|
December 31,
|
|
|
2022 vs. 2021
|
|
|
|
2022
|
|
|
2021
|
|
|
$
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
D&O, health and clinical insurance expense
|
|
$ |
103,000 |
|
|
$ |
71,000 |
|
|
$ |
32,000 |
|
|
|
45 |
% |
Directors’ fees
|
|
|
37,000 |
|
|
|
37,000 |
|
|
|
— |
|
|
|
—
|
%
|
Rent and utility expense
|
|
|
11,000 |
|
|
|
20,000 |
|
|
|
(9,000 |
) |
|
|
(45 |
)% |
Stock-based compensation expense – Officers & Directors
|
|
|
14,000 |
|
|
|
111,000 |
|
|
|
(97,000 |
) |
|
|
(87 |
)% |
Business development expense
|
|
|
4,000 |
|
|
|
— |
|
|
|
4,000 |
|
|
|
—
|
%
|
Other G&A
|
|
|
22,000 |
|
|
|
27,000 |
|
|
|
(5,000 |
) |
|
|
(19 |
)% |
Total
|
|
$ |
191,000 |
|
|
$ |
266,000 |
|
|
$ |
(75,000 |
) |
|
|
(28 |
)% |
General and administrative expenses decreased during the three
months ended December 31, 2022, primarily due to a decrease in rent
and utility expense of $9,000, a decrease in stock-based
compensation expense – Officers & Directors of $97,000 and a
decrease in other G&A expense of $5,000 offset by an increase
in clinical insurance expense of $32,000 and an increase in
business development expense of $4,000 during the three months
ended December 31, 2022.
There was a decrease in stock-based compensation expenses for
Officers & Directors during the three months ended December 31,
2022, because stock-based compensation expense was fully expensed
on October 31, 2022.
Officers’ Payroll and Payroll Tax
Expenses
Below is a summary of our Officers’ payroll and payroll tax
expenses (rounded to nearest thousand):
|
|
For the three months ended
|
|
|
Change
|
|
|
|
December 31,
|
|
|
2022 vs. 2021
|
|
|
|
2022
|
|
|
2021
|
|
|
$
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Officers’ payroll expenses
|
|
$ |
116,000 |
|
|
|
116,000 |
|
|
$ |
- |
|
|
|
-
|
%
|
Payroll tax expenses
|
|
|
2,000 |
|
|
|
(53,000 |
) |
|
|
55,000 |
|
|
|
104 |
% |
|
|
$ |
118,000 |
|
|
$ |
63,000 |
|
|
$ |
55,000 |
|
|
|
87 |
% |
There was no change in officers’ payroll expenses for the Company
during the three months ended December 31, 2022 and there was an
increase in payroll tax expense due to the adjustment we made on
the over-provision of payroll taxes in 2021.
Professional Fees
Below is a summary of our Professional fees (rounded to nearest
thousand):
|
|
For the three months ended
|
|
|
Change
|
|
|
|
December 31,
|
|
|
2022 vs. 2021
|
|
|
|
2022
|
|
|
2021
|
|
|
$
|
|
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Audit, legal and professional fees
|
|
$
|
57,000
|
|
|
$
|
92,000
|
|
|
$
|
(35,000
|
)
|
|
|
(38
|
)%
|
Professional fees decreased during the three months ended December
31, 2022 primarily related to decrease in legal fees and other
professional fees in 2022.
Other Operating Income and (Loss)
There was an increase in other expense which represents equity in
loss from an investment of approximately $45,000 and $0 for the
three months ended December 31, 2022 and 2021, respectively (see
Note 4. – Equity Investment).
Other Income (Expense)
Below is a summary of our other income (expense) (rounded to
nearest thousand):
|
|
For the three months ended
|
|
|
Change
|
|
|
|
December 31,
|
|
|
2022 vs. 2021
|
|
|
|
2022
|
|
|
2021
|
|
|
$ |
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
|
|
$ |
— |
|
|
|
172,000 |
|
|
$ |
(172,000 |
) |
|
|
(100 |
)% |
Interest expense – debt
|
|
|
(5,000 |
) |
|
|
(17,000 |
) |
|
|
12,000 |
|
|
|
(71 |
)% |
Interest expense – preferred stock liability
|
|
|
(9,000 |
) |
|
|
(14,000 |
) |
|
|
5,000 |
|
|
|
(36 |
)% |
Other Income (Expense), net
|
|
$ |
(14,000 |
) |
|
$ |
141,000 |
|
|
$ |
(155,000 |
) |
|
|
(110 |
)% |
There was a decrease in other income which represents the
forgiveness of the PPP Loan in 2021. There was a decrease in
interest expenses paid on the note payable – related party, because
the Company partially paid the note payable balance due to Mr.
Ehrlich, the Company’s Chairman and CEO (see Note 12. Convertible
Note Payable – Related Party of the Notes to Condensed Consolidated
Financial Statements).
Net Losses
We incurred net losses of $0.4 million and $1.9 million for the
three months ended December 31, 2022 and 2021, respectively,
because of the above-mentioned factors.
For the six months ended December 31, 2022 and
2021
Revenue
We generated no revenue and incurred operating expenses of
approximately $1.7 million and $4.0 million for the six months
ended December 31, 2022 and 2021, 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 six months ended
|
|
|
Change
|
|
|
|
December 31,
|
|
|
2022 vs. 2021
|
|
|
|
2022
|
|
|
2021
|
|
|
$
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical studies and development research
|
|
$ |
801,000 |
|
|
$ |
2,507,000 |
|
|
$ |
(1,706,000 |
) |
|
|
(68 |
)% |
Refunds of unused project deposits
|
|
|
(175,000 |
) |
|
|
— |
|
|
|
(175,000 |
) |
|
|
—
|
%
|
Reimbursement for Brilacidin manufacturing expenses
|
|
|
(238,000 |
) |
|
|
— |
|
|
|
(238,000 |
) |
|
|
—
|
%
|
Employees payroll and payroll tax expenses related to R&D
Department
|
|
|
224,000 |
|
|
|
405,000 |
|
|
|
(181,000 |
) |
|
|
(45 |
)% |
Stock-based compensation – employee
|
|
|
36,000 |
|
|
|
40,000 |
|
|
|
(4,000 |
) |
|
|
(10 |
)% |
Stock-based compensation – consultants
|
|
|
2,000 |
|
|
|
41,000 |
|
|
|
(39,000 |
) |
|
|
(95 |
)% |
Depreciation and amortization expenses
|
|
|
186,000 |
|
|
|
191,000 |
|
|
|
(5,000 |
) |
|
|
(3 |
)% |
Total
|
|
$ |
836,000 |
|
|
$ |
3,184,000 |
|
|
$ |
(2,348,000 |
) |
|
|
(74 |
)% |
Research and development expenses for proprietary programs
decreased during the six months ended December 31, 2022 compared
with the six months ended December 31, 2021, primarily due to less
spending on our Brilacidin program, increase in refunds of unused
project deposits of $175,000, and increase in reimbursement for
Brilacidin manufacturing expenses of $238,000 for the six months
ended December 31, 2022.
Employees payroll and payroll tax expenses decreased during the six
months ended December 31, 2022 due to no bonus paid during the six
months ended December 31, 2022 compared with the six months ended
December 31, 2021.
Stock-based compensation for employee decreased during the six
months ended December 31, 2022 due to no new issuance of stock
options during the six months ended December 31, 2022 compared with
the six months ended December 31, 2021.
Stock-based compensation - consultants decreased during the six
months ended December 31, 2022 due to no new issuance of stock
options during the six months ended December 31, 2022 compared with
the six months ended December 31, 2021.
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.
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 six months ended
|
|
|
Change
|
|
|
|
December 31,
|
|
|
2022 vs. 2021
|
|
|
|
2022
|
|
|
2021
|
|
|
$
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
D&O, health and clinical insurance expense
|
|
$ |
171,000 |
|
|
$ |
140,000 |
|
|
$ |
31,000 |
|
|
|
22 |
% |
Directors’ fees
|
|
|
75,000 |
|
|
|
75,000 |
|
|
|
— |
|
|
|
—
|
%
|
Rent and utility expense
|
|
|
24,000 |
|
|
|
41,000 |
|
|
|
(17,000 |
) |
|
|
(41 |
)% |
Stock-based compensation expense – Officers & Directors
|
|
|
161,000 |
|
|
|
111,000 |
|
|
|
50,000 |
|
|
|
45 |
% |
Business development expense
|
|
|
4,000 |
|
|
|
25,000 |
|
|
|
(21,000 |
) |
|
|
(84 |
)% |
Other G&A
|
|
|
47,000 |
|
|
|
59,000 |
|
|
|
(12,000 |
) |
|
|
(20 |
)% |
Total
|
|
$ |
482,000 |
|
|
$ |
451,000 |
|
|
$ |
31,000 |
|
|
|
7 |
% |
General and administrative expenses increased during the six months
ended December 31, 2022, primarily due to an increase in insurance
expense of $31,000 and an increase in stock-based compensation
expense – Officers & Directors of $50,000, offset by a decrease
in rent and utility expense of $17,000, a decrease in business
development expense of $21,000 and a decrease in other G&A
expense of $12,000 during the six months ended December 31,
2022.
There was an increase in stock-based compensation expenses for
Officers & Directors during the six months ended December 31,
2022, because stock-based compensation expense for the prior period
included stock-based compensation expense for three months only
since the options were issued on October 10, 2021.
Officers’ Payroll and Payroll Tax
Expenses
Below is a summary of our Officers’ payroll and payroll tax
expenses (rounded to nearest thousand):
|
|
For the Six months ended
|
|
|
Change
|
|
|
|
December 31,
|
|
|
2022 vs. 2021
|
|
|
|
2022
|
|
|
2021
|
|
|
$
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Officers’ payroll expenses
|
|
$ |
233,000 |
|
|
|
233,000 |
|
|
$ |
— |
|
|
|
—
|
%
|
Payroll tax expenses
|
|
|
3,000 |
|
|
|
(51,000 |
) |
|
|
54,000 |
|
|
|
106 |
% |
|
|
$ |
236,000 |
|
|
$ |
182,000 |
|
|
$ |
54,000 |
|
|
|
30 |
% |
There was no change in officers’ payroll expenses for the Company
during the six months ended December 31, 2022 and there was an
increase in payroll tax expense due to the adjustment we made on
the over-provision of payroll taxes in 2021.
Professional Fees
Below is a summary of our Professional fees (rounded to nearest
thousand):
|
|
For the six months ended
|
|
|
Change
|
|
|
|
December 31,
|
|
|
2022 vs. 2021
|
|
|
|
2022
|
|
|
2021
|
|
|
$
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Audit, legal and professional fees
|
|
$ |
161,000 |
|
|
$ |
220,000 |
|
|
$ |
(59,000 |
) |
|
|
(27 |
)% |
Professional fees decreased during the six months ended December
31, 2022 primarily related to decrease in legal fees and other
professional fees in 2022.
Other Operating Income and (Loss)
There was an increase in other expense which represents equity in
loss from an investment of approximately $14,000 and $0 for the six
months ended December 31, 2022 and 2021, respectively (see Note 4.
– Equity Investment).
Other Income (Expense)
Below is a summary of our other income (expense) (rounded to
nearest thousand):
|
|
For the six months ended
|
|
|
Change
|
|
|
|
December 31,
|
|
|
2022 vs. 2021
|
|
|
|
2022
|
|
|
2021
|
|
|
$
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
|
|
$ |
— |
|
|
|
172,000 |
|
|
$ |
(172,000 |
) |
|
|
(100 |
)% |
Interest expense - debt
|
|
|
(12,000 |
) |
|
|
(50,000 |
) |
|
|
38,000 |
|
|
|
(76 |
)% |
Interest expense - preferred stock liability
|
|
|
(17,000 |
) |
|
|
(14,000 |
) |
|
|
(3,000 |
) |
|
|
21 |
% |
Other Income (Expense), net
|
|
$ |
(29,000 |
) |
|
$ |
108,000 |
|
|
$ |
(137,000 |
) |
|
|
(127 |
)% |
There was a decrease in other income which represents the
forgiveness of the PPP Loan in 2021. There was a decrease in
interest expenses paid on the note payable - related party, because
the Company paid partially the note payable balance due to Mr.
Ehrlich, the Company’s Chairman and CEO (see Note 12. Convertible
Note Payable - Related Party of the Notes to Condensed Consolidated
Financial Statements).
Net Losses
We incurred net losses of $1.8 million and $3.9 million for the six
months ended December 31, 2022 and 2021, respectively, because of
the above-mentioned factors.
Liquidity, Going Concern and Capital Resources
Projected
Future Working Capital Requirements - Next 12
Months
As of December 31, 2022, we had approximately $2.4 million in cash
compared to $3.8 million of cash as of June 30, 2022, and as of the
date of this filing, we have approximately $2.2 million in cash.
Contingent upon sufficient funding, we currently anticipate that
future budget expenditures will be approximately $2.0 million for
the next 12 months, including approximately $0.8 million for
development activities, supportive research, and drug
manufacturing.
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.
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 our Annual Report on Form
10-K.
In the event that we are unable to 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 (for example 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.
Going Concern
Our financial statements were prepared assuming we will continue as
a going concern which contemplates the realization of assets and
satisfaction of liabilities in the normal course of business. We
have negative working capital of $2.3 million and have incurred
losses since inception of $124 million. We expect to incur further
losses in the development of our business and have been dependent
on raising capital to fund operations from inception. These
conditions raise substantial doubt about our ability to continue as
a going concern. Management’s plans include continuing to finance
operations through the private or public placement of debt and/or
equity securities and the reduction of expenditures. However, no
assurance can be given at this time as to whether we will be able
to achieve these objectives. The financial statements do not
include any adjustment relating to the recoverability and
classification of recorded asset amounts or the amounts and
classification of liabilities that might be necessary should we be
unable to continue as a going concern.
Shelf Registration Statement - Current
Status
The Company does not satisfy the conditions for use of Form S-3 for
primary offerings of securities, and as a result, the Company
generally may only utilize Form S-1 to register the sale of its
securities. 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 six months
ended December 31, 2022 and 2021 (rounded to nearest thousand):
|
|
Six Months ended
|
|
|
Increase/
|
|
|
|
December 31,
|
|
|
(Decrease)
|
|
|
|
2022
|
|
|
2021
|
|
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
$ |
(1,268,000 |
) |
|
$ |
(4,201,000 |
) |
|
|
(70 |
)% |
Net cash used in investing activities
|
|
|
(31,000 |
) |
|
|
(44,000 |
) |
|
|
(30 |
)% |
Net cash provided by (used in) financing activities
|
|
|
(85,000 |
) |
|
|
3,973,000 |
|
|
|
(102 |
)% |
Net decrease in cash
|
|
$ |
(1,384,000 |
) |
|
$ |
(272,000 |
) |
|
|
409 |
% |
Operating Activities
Net cash used in operating activities for the six months ended
December 31, 2022 and 2021 was $1.3 million and $4.2 million, a
decrease of $2.9 million. For the six months ended December 31,
2022 operating cash flows reflect our net loss of $1.8 million,
noncash charges (stock-based compensation expense, amortization
expense and equity in loss from investment) of $0.4 million and a
net increase from changes in our working capital accounts of
approximately $0.1 million.
Increases in operating cash flows caused by working capital changes
include net increase in accounts payable, accrued expenses and
operating lease liability of $0.1 million.
Investing activities
Net cash used in our investing activities for the six months ended
December 31, 2022, as compared to net cash used in our investing
activities in 2021, decreased by approximately $13,000. The
decrease was due primarily to a decrease in patent costs.
Financing activities
Net cash used in financing activities for the six months ended
December 31, 2022, as compared to net cash provided by our
financing activities in 2021, decreased by approximately $4.1
million. The decrease was due primarily to decreases in proceeds
from exercise of warrants to purchase Series B Preferred stock.
During the six months ended December 31, 2022, the Company did not
raise any funds and repaid a note payable of $15,000 and paid
dividends on preferred stock of $70,000.
During the six months ended December 31, 2021, the Company raised
$5.0 million in net cash proceeds, from exercise of warrants to
purchase preferred stock and repaid $1.0 million of a note payable
to officer.
Requirement for Additional Working Capital
The Company, contingent on future sales of its securities,
currently expects to incur total operating expenses of
approximately $2.0 million for the next 12 months, including
approximately $0.8 million for development activities, supportive
research, and drug manufacturing. The Company has limited
experience with pharmaceutical product 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.
In the event that we are unable to 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 (for example 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 10. 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.
Recently Issued Accounting Pronouncements
We do not expect the adoption of recently issued accounting
pronouncements to have a significant impact on our results of
operation, financial position or cash flow.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
Not applicable.
ITEM 4. CONTROLS AND
PROCEDURES
Evaluation of Disclosure Controls and
Procedures
We have established disclosure controls and procedures to ensure
that the information required to be disclosed by the Company in the
reports that it files or submits under the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), is recorded, processed,
summarized and reported within the time periods specified in SEC
rules and forms and that such information is accumulated and
communicated to management, including our principal executive
officer and principal financial officer, as appropriate to allow
timely decisions regarding required disclosure.
As of December 31, 2022, management, with the participation of our
principal executive officer and principal financial officer,
carried out an evaluation of the effectiveness of the design and
operation of the Company’s disclosure controls and procedures (as
defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act).
Based on such evaluation, as of December 31, 2022, 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 December 31, 2022, 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.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
See Note 10. Commitments and Contingencies 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, 2022, 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, 2022.
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
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
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: February 15, 2023
|
By:
|
/s/ Leo Ehrlich
|
|
|
Name:
|
Leo Ehrlich
|
|
|
Title:
|
Chief Executive Officer, Chief Financial Officer,
Principal Accounting Officer, and Secretary
|
|
Innovation Pharmaceuticals (PK) (USOTC:IPIX)
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Innovation Pharmaceuticals (PK) (USOTC:IPIX)
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From Sep 2022 to Sep 2023