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 March 31 , 2023
☐ TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number:
001-41160
ALLARITY THERAPEUTICS,
INC.
(Exact Name of Registrant
as Specified in Its Charter)
Delaware 87-2147982
(State or Other Jurisdiction Of
Incorporation or Organization) (I.R.S. Employer
Identification Number)
24 School Street , 2 nd Floor , Boston , MA 02108
(Address of Principal Executive Offices) (Zip Code)
(401) 426-4664
(Registrant’s telephone number, including
area code)
Not Applicable
(Former Name, Former Address and Former Fiscal
Year, if Changed Since Last Report)
Securities registered pursuant to Section 12(b)
of the Act:
Title of Each Class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.0001 per share ALLR The Nasdaq Stock Market LLC
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 issuer 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 and post such
files). Yes ☒ No ☐
Indicate by checkmark 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 ☒
As of May 11, 2023, the registrant had 19,143,273 shares of common
stock outstanding.
Table
of Contents
Page
Forward Looking Statements
ii
PART I – FINANCIAL INFORMATION
1
Item
1.
Condensed Consolidated Financial Statements
1
Condensed Consolidated Balance Sheets as at March 31, 2023 (Unaudited) and December 31, 2022
1
Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2023 and 2022 (Unaudited)
2
Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the three months ended March 31, 2023 and 2022 (Unaudited)
3
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and 2022 (Unaudited)
5
Notes to Condensed Consolidated Financial Statements for the three months ended March 31, 2023 and 2022 (Unaudited)
6
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
26
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
34
Item
4.
Controls and Procedures
34
PART II – OTHER INFORMATION
36
Item
1.
Legal Proceedings
36
Item
1A.
Risk Factors
36
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
38
Item
3.
Defaults Upon Senior Securities
39
Item
4.
Mine Safety Disclosures
39
Item
5.
Other Information
39
Item
6.
Exhibits
40
Signatures
41
i
Unless the context indicates
otherwise, references in this Quarterly Report on Form 10-Q (the “Quarterly Report” or “Report”) to the “Company,”
“Allarity,” “we,” “us,” “our” and similar terms refer to Allarity Therapeutics, Inc.,
Allarity Therapeutics A/S (as predecessor) and its respective consolidated subsidiaries. On March 24, 2023, the Company affected a 1-for-35
reverse stock split of the shares of common stock of the Company (the “Reverse Stock Split”). All historical share and per
share amounts reflected throughout this Quarterly Report have been adjusted to reflect the Reverse Stock Split.
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form
10-Q includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All
statements in this report other than statements of historical fact are forward-looking statements for purposes of these provisions, including
any statements of the Company’s plans and objectives for future operations, the Company’s future financial or economic performance
(including known or anticipated trends), and the assumptions underlying or related to the foregoing. Statements that include the use
of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,”
“estimates,” “potential,” or “continue,” or the negative thereof, or other comparable terminology,
are forward-looking statements. These risks and uncertainties include, but are not limited to, the factors described in the section captioned
“Risk Factors” in our Annual Report on Form 10-K (“Form 10-K”), filed with the Securities and Exchange Commission
(“SEC”) on March 13, 2023. Forward-looking statements reflect our current views with respect to future events and are based
on assumptions and subject to risks and uncertainties. You should read these factors and the other cautionary statements made in this
report as being applicable to all related forward-looking statements wherever they appear in this report. If one or more of these factors
materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from
any future results, performance or achievements expressed or implied by these forward-looking statements.
Any forward-looking statements
contained in this Quarterly Report are only estimates or predictions of future events based on information currently available to our
management and management’s current beliefs about the potential outcome of future events. Whether these future events will occur
as management anticipates, whether we will achieve our business objectives, and whether our revenues, operating results or financial
condition will improve in future periods are subject to numerous risks. There are a number of important factors that could cause actual
results to differ materially from the results anticipated by these forward-looking statements. These important factors include those
that we discuss under the heading “Risk Factors” in this Quarterly Report and in other reports filed from time to time with
the SEC. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance
or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking
statements.
All forward-looking statements
and descriptions of risks included in this report are made as of the date hereof based on information available to the Company as of
the date hereof, and except as required by applicable law, the Company undertakes no obligation to publicly update any forward-looking
statements, whether as a result of new information, future events or otherwise. You should, however, consult the risks and other disclosures
described in the reports the Company files from time to time with the SEC after the date of this report for updated information.
ii
PART I – FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
ALLARITY THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except for share and per share data)
March 31,
December 31,
2023
2022
(Unaudited)
ASSETS
Current assets:
Cash
$ 295
$ 2,029
Other current assets
1,067
1,559
Prepaid expenses
315
591
Tax credit receivable
1,289
789
Total current assets
2,966
4,968
Non-current assets:
Property, plant and equipment, net
25
21
Operating lease right of use assets
—
6
Intangible assets
9,711
9,549
Total assets
$ 12,702
$ 14,544
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY
Current liabilities:
Accounts payable
$ 6,449
$ 6,251
Accrued liabilities
2,351
1,904
Income taxes payable
36
41
Operating lease liabilities, current
—
8
Warrant liability
65
374
Convertible debt and accrued interest, net of debt discount
2,687
2,644
Total current liabilities
11,588
11,222
Non-current liabilities:
Convertible promissory note and accrued interest, net of debt discount
1,110
1,083
Deferred tax
343
349
Total liabilities
13,041
12,654
Commitments and contingencies (Note 17)
Redeemable preferred stock (500,000 shares authorized)
Series A Convertible Preferred stock $ 0.0001 par value ( 20,000 shares designated) shares issued and outstanding at March 31, 2023 and December 31, 2022 were 9,748 and 13,586 , respectively (liquidation preference of $ 121 at March 31, 2023)
1,436
2,001
Series B Preferred stock $ 0.0001 par value ( 200,000 shares designated); shares issued at March 31, 2023 and December 31, 2022 were 0 and 190,786 , respectively (liquidation preference of $ 0 at March 31, 2023)
—
2
Series C Convertible Preferred stock $ 0.0001 par value ( 50,000 and 0 shares designated at March 31, 2023 and December 31, 2022, respectively); shares issued and outstanding at March 31, 2023 were 50,000 (liquidation preference of $ 1,418 at March 31, 2023)
1,327
—
Total redeemable preferred stock
2,763
2,003
Stockholders’ (deficit) equity
Common stock, $ 0.0001 par value ( 750,000,000 and 857,143 shares authorized, at March 31, 2023 and December 31, 2022, respectively); shares issued and outstanding at March 31, 2023 and December 31, 2022 were 1,188,387 and 454,225 , respectively
—
—
Additional paid-in capital
83,437
83,158
Accumulated other comprehensive loss
( 637 )
( 721 )
Accumulated deficit
( 85,902 )
( 82,550 )
Total stockholders’ deficit
( 3,102 )
( 113 )
Total liabilities, preferred stock and stockholders’ (deficit) equity
$ 12,702
$ 14,544
See accompanying notes to condensed consolidated
financial statements.
1
ALLARITY THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(U.S. dollars in thousands, except for share and per share data)
Three months ended
March 31,
2023
2022
Operating expenses:
Research and development
$ 1,427
$ 1,289
Impairment of intangible assets
—
14,007
General and administrative
2,232
3,013
Total operating expenses
3,659
18,309
Loss from operations
( 3,659 )
( 18,309 )
Other income (expenses)
Gain on the sale of IP
—
1,780
Interest income
4
—
Interest expense
( 92 )
( 39 )
Finance expense
( 9 )
—
Loss on investment
—
( 36 )
Foreign exchange gains (losses)
95
( 269 )
Change in fair value adjustment of derivative and warrant liabilities
309
12,566
Net other income
307
14,002
Net loss for the period before tax benefit (expense)
( 3,352 )
( 4,307 )
Income tax benefit (expense)
—
1,227
Net loss
( 3,352 )
( 3,080 )
Deemed dividend of 5 % on Series C Convertible Preferred stock
( 4 )
—
Deemed dividend of 8 % on Series A Convertible Preferred stock
—
( 1,572 )
Net loss attributable to common stockholders
$ ( 3,356 )
$ ( 4,652 )
Basic and diluted net loss per common stock
$ ( 4.43 )
$ ( 19.64 )
Weighted-average number of common stock outstanding, basic and diluted
758,144
236,811
Other comprehensive loss, net of tax:
Net loss
$ ( 3,352 )
$ ( 3,080 )
Change in cumulative translation adjustment
84
( 214 )
Total comprehensive loss attributable to common stockholders
$ ( 3,268 )
$ ( 3,294 )
See accompanying notes to condensed consolidated
financial statements.
2
ALLARITY THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
For the three months ended March 31, 2023 and 2022
(Unaudited)
(U.S. dollars in thousands, except for share data)
Series A Convertible
Preferred Stock
Common Stock
Additional
Paid in
Accumulated
Other
Comprehensive
Accumulated
Total
Stockholders’
Number
Value, net
Number
Value
Capital
Loss
Deficit
Equity
Balance, December 31, 2021
19,800
$ 632
231,315
$ 1
$ 85,243
$ ( 600 )
$ ( 66,492 )
$ 18,152
Conversion of preferred stock into common stock, net
( 1,973 )
( 62 )
21,322
—
381
—
—
381
Deemed dividend of 8 % on preferred stock
—
1,572
—
—
( 1,572 )
—
—
( 1,572 )
Stock based compensation
—
—
—
—
1,065
—
—
1,065
Currency translation adjustment
—
—
—
—
—
( 214 )
—
( 214 )
Loss for the period
—
—
—
—
—
—
( 3,080 )
( 3,080 )
Balance, March 31, 2022
17,827
$ 2,142
252,637
$ 1
$ 85,117
$ ( 814 )
$ ( 69,572 )
$ 14,732
See accompanying notes to condensed consolidated
financial statements.
3
Series
A Convertible
Preferred Stock
Series
B
Preferred Stock
Series
C Convertible
Preferred Stock
Common
Stock
Additional
Paid in
Accumulated
Other
Comprehensive
Accumulated
Total
Stockholders’
Equity
Number
Value
Number
Value
Number
Value
Number
Value
Capital
Loss
Deficit
(Deficit)
Balance, December 31, 2022
13,586
$ 2,001
190,786
$ 2
—
$ —
454,225
$ —
$ 83,158
$ ( 721 )
$ ( 82,550 )
$ ( 113 )
Issuance of Series C Convertible
Preferred Stock, net
—
—
—
—
50,000
1,160
—
—
—
—
—
—
Deemed dividend of 5 % and accretion of Series C Convertible Preferred Stock to redemption value
—
—
—
—
—
167
—
—
( 167 )
—
—
( 167 )
Round up of common shares
issued as a result of 1-for-35 reverse stock split
—
—
—
—
—
—
12,700
—
—
—
—
—
Conversion of Preferred Stock
into common stock, net
( 3,838 )
( 565 )
—
—
—
—
721,462
—
565
—
—
565
Redemption of Series B Preferred
Stock
—
—
( 190,786 )
( 2 )
—
—
—
2
—
—
2
Stock based compensation
(recoveries)
—
—
—
—
—
—
—
—
( 121 )
—
—
( 121 )
Currency translation adjustment
—
—
—
—
—
—
—
—
—
84
—
84
Loss
for the period
—
—
—
—
—
—
—
—
—
—
( 3,352 )
( 3,352 )
Balance,
March 31, 2023
9,748
$ 1,436
—
$ —
50,000
$ 1,327
1,188,387
$ —
$ 83,437
$ ( 637 )
$ ( 85,902 )
$ ( 3,102 )
See accompanying notes to condensed consolidated
financial statements.
4
ALLARITY THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(U.S. dollars in thousands)
Three months ended
March 31,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss for the period
$ ( 3,352 )
$ ( 3,080 )
Adjustments to reconcile net loss to net cash used in operating activities:
Gain on the sale of IP
—
( 1,780 )
Depreciation and amortization
10
23
Intangible asset impairment
—
14,007
Stock-based compensation (recoveries)
( 121 )
1,065
Unrealized foreign exchange (gain) loss
( 87 )
255
Non-cash finance expense
4
—
Non-cash interest
83
26
Loss on investment
—
36
Change in fair value adjustment of warrant and derivative liabilities
( 309 )
( 12,566 )
Deferred income taxes
—
( 1,227 )
Changes in operating assets and liabilities:
Other current assets
( 19 )
470 )
Tax credit receivable
( 23 )
( 455 )
Prepaid expenses
( 6 )
( 1,227 )
Accounts payable
198
5,036
Accrued liabilities
434
( 6,308 )
Income taxes payable
( 5 )
( 7 )
Operating lease liability
( 8 )
( 23 )
Net cash used in operating activities
( 3,201 )
( 5,755 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from the sale of IP
—
809
Net cash provided by investing activities
—
809
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from Series C Convertible Preferred Stock issuance, net of costs
1,160
—
Redemption of Series B Preferred Stock
( 2 )
—
Net cash provided by financing activities
1,158
—
Net decrease in cash
( 2,043 )
( 4,946 )
Effect of exchange rate changes on cash
309
( 65 )
Cash, beginning of period
2,029
19,555
Cash, end of period
$ 295
$ 14,544
Supplemental information
Cash paid for income taxes
6
1
Cash paid for interest
9
13
Supplemental disclosure of non-cash investing and financing activities:
Offset of payable against receivable from sale of IP
—
971
Conversion of Series A Convertible Preferred stock to equity, net
565
381
Accrued liability on Series A Convertible Preferred Stock
—
134
Deemed 8 % dividend on Series A Convertible Preferred Stock
—
1,572
Deemed 5 % dividend on Series C Convertible Preferred Stock, and accretion
of Series C Preferred shares to redemption value
167
—
See accompanying notes to condensed consolidated
financial statements.
5
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For the three months ended March 31, 2023 and March 31, 2022
(UNAUDITED)
(U.S. dollars in thousands, except
for share and per share data and where otherwise noted)
1. Organization, Principal Activities, and
Basis of Presentation
Allarity Therapeutics, Inc.
and Subsidiaries (the “Company”) is a clinical stage pharmaceutical company that develops drugs for the personalized treatment
of cancer using drug specific companion diagnostics generated by its proprietary drug response predictor technology, DRP ® .
Additionally, the Company, through its Danish subsidiary, Allarity Denmark (previously Oncology Venture ApS), specializes in the research
and development of anti-cancer drugs.
The Company’s principal
operations are located at Venlighedsvej 1, 2970 Horsholm, Denmark. The Company’s business address in the Unites States is located
at 24 School Street, 2 nd Floor, Boston, MA 02108.
(a) Reverse Stock Split
On March 24, 2023, the Company
affected a 1-for-35 reverse stock split of the shares of common stock of the Company. All historical share and per share amounts reflected
throughout the financial statements (as defined below in 1(b) and these notes to the financial statements have been adjusted to reflect
the Reverse Stock Split. See Note 11(d).
(b) Liquidity and Going Concern
The accompanying unaudited
condensed interim consolidated financial statements (the “financial statements”) have been prepared on the basis of continuity
of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The accompanying
financial statements do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that
might be necessary if the Company is unable to continue as a going concern.
Pursuant to the requirements
of Accounting Standard Codification (ASC) 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going
Concern, management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about
the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. This
evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been
fully implemented as of the date of these financial statements, and (1) is probable that the plan will be effectively implemented
within one year after the date the financial statements are issued, and (2) it is probable that the plan, when implemented, will
mitigate the relevant condition or events that raise substantial doubt about the entity’s ability to continue as a going concern
within one year after the date the financials are issued. Certain elements of the Company’s operating plan to alleviate the conditions
that raise substantial doubt are outside of the Company’s control and cannot be included in management’s evaluation under
the requirements of ASC 205-40.
Since inception, the Company
has devoted substantially all its efforts to business planning, research and development, clinical expenses, recruiting management and
technical staff, and securing funding via collaborations. The Company has historically funded its operations with proceeds received from
its collaboration arrangements, sale of equity capital and proceeds from sales of convertible notes.
The Company has incurred
significant losses and has an accumulated deficit of $ 85.9 million as of March 31, 2023. As of March 31, 2023, our cash of $ 295
is insufficient to fund our current operating plan and planned capital expenditures for the next 12 months. These conditions give rise
to substantial doubt over the Company’s ability to continue as a going concern.
6
Management’s plans to mitigate
the conditions or events that raise substantial doubt include additional funding through public equity, private equity, debt financing,
collaboration partnerships, or other sources. On April 21, 2023, the Company completed a public offering of its common stock and pre-funded
warrant along with the common stock purchase warrant, for aggregate gross proceeds of approximately $ 7.5 million, before deducting placement
agents’ fees and offering expenses payable, of which approximately $ 5 million was used from the proceeds to satisfy the indebtedness
due to 3i, LP in connection with certain secured promissory notes issued to 3i, LP and alternative conversion amount due to 3i, LP in
connection with exercise of shares of Series A Convertible Preferred Stock, which resulted in net proceeds of $ 1.9 million. See Note 18(a).
In light of the Company’s cash position as of May 11, 2023, of $ 759 , the Company does not have sufficient funds for its current
operations and planned capital expenditures. As discussed above the Company intends to seek capital through sale of its securities or
other sources. There are no assurances, however, that the Company will be successful in raising additional working capital, or if it is
able to raise additional working capital, it may be unable to do so on commercially favorable terms. The Company’s failure to raise
capital or enter into other such arrangements if and when needed would have a negative impact on its business, results of operations and
financial condition and its ability to develop its product candidates.
Although management continues
to pursue its funding plans, there is no assurance that the Company will be successful in obtaining sufficient funding to fund continuing
operations on terms acceptable to the Company, if at all. Accordingly, based upon cash on hand at the issuance date of these financial
statements the Company does not have sufficient funds to finance its operations for at least twelve months from the issuance date and
therefore has concluded that substantial doubt exists about the Company’s ability to continue as a going concern.
(c) Basis of Presentation
The accompanying financial
statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America
(“U.S. GAAP” or “GAAP”) as established by the Financial Accounting Standards Board (the “FASB”) for
interim financial information and the rules and regulations of the Securities and Exchange Commission (the “SEC”).
The accompanying financial
statements contain all normal and recurring adjustments necessary to state fairly the consolidated balance sheet, results of operations
and comprehensive loss, statements of changes in redeemable convertible preferred stock and stockholders’ equity (deficit), and
cash flows of the Company for the interim periods presented. Except as otherwise disclosed, all such adjustments consist only of those
of a normal recurring nature. Operating results for the three months ended March 31, 2023, are not necessarily indicative of the results
that may be expected for the current year ending December 31, 2023. The financial data presented herein do not include all disclosures
required by U.S. GAAP and should be read in conjunction with the audited consolidated financial statements and accompanying notes as
of and for the years ended December 31, 2022 and 2021, thereto included in the Company’s Annual Report on Form 10-K filed with
the Securities and Exchange Commission on March 13, 2023.
The preparation of these
financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities as of the date of the financial statements, and the reported amounts of revenues and expenses during the reporting
periods. The results of operations and cash flows for the interim periods included in these financial statements are not necessarily
indicative of the results to be expected for any future period or the entire fiscal year.
(d) Principles of Consolidation
The financial statements
include the accounts of the Company and its wholly owned subsidiaries:
Name
Country
of Incorporation
Allarity
Acquisition Subsidiary Inc.
United States
Allarity
Therapeutics Europe ApS (formerly Oncology Venture Product Development ApS)
Denmark
Allarity
Therapeutics Denmark ApS (formerly OV-SPV2 ApS)
Denmark
MPI
Inc.*
United States
Oncology
Venture US Inc.*
United States
* In the process of being dissolved because inactive.
All intercompany transactions
and balances, including unrealized profits from intercompany sales, have been eliminated upon consolidation.
7
(e) Risks and Uncertainties
The Company is subject to
risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical
trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully
commercialize and gain market acceptance of its product candidates, dependence on key personnel and collaboration partners, protection
of proprietary technology, compliance with government regulations, development by competitors of technological innovations, and the ability
to secure additional capital to fund operations. Product candidates currently under development will require significant additional research
and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. Even if the Company’s
research and development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product
sales.
2. Summary of Significant Accounting Policies
(a) Use of Estimates and Assumptions
The preparation of financial
statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and
liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of
revenues and expenses during the reporting years. Significant estimates and assumptions reflected in these financial statements include,
but are not limited to, the fair value of the Series A, Series B, and Series C Preferred Stock, warrants, convertible debt, convertible
promissory note, and the accrual for research and development expenses, fair values of acquired intangible assets and impairment review
of those assets, share based compensation expense, and income tax uncertainties and valuation allowances. The Company bases its estimates
on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the
circumstances. Estimates are periodically reviewed considering reasonable changes in circumstances, facts, and experience. Changes in
estimates are recorded in the period in which they become known and if material, their effects are disclosed in the notes to the financial
statements. Actual results could differ from those estimates or assumptions.
(b) Foreign currency and currency translation
The functional currency is
the currency of the primary economic environment in which an entity’s operations are conducted. The Company and its subsidiaries
operate mainly in Denmark and the United States. The functional currencies of the Company’s subsidiaries are their local currency.
The Company’s reporting
currency is the U.S. dollar. The Company translates the assets and liabilities of its Denmark subsidiaries into the U.S. dollar at the
exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during
each monthly period. Unrealized translation gains and losses are recorded as a cumulative translation adjustment, which is included in
the condensed consolidated statements of changes in redeemable convertible preferred stock and stockholders’ equity (deficit) as
a component of accumulated other comprehensive income (loss).
Monetary assets and liabilities
denominated in currencies other than the functional currency are remeasured into the functional currency at rates of exchange prevailing
at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are re-measured into the functional
currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions
are included in the determination of net loss for the respective periods. Adjustments that arise from exchange rate translations are
included in other comprehensive income (loss) in the condensed consolidated statements of operations and comprehensive loss as incurred.
8
(c) Concentrations of credit risk and of significant
suppliers
Financial instruments that
potentially expose the Company to concentrations of credit risk consist primarily of cash. The Company maintains its cash in financial
institutions in amounts that could exceed government-insured limits. The Company does not believe it is subject to additional credit
risks beyond those normally associated with commercial banking relationships. The Company has not experienced losses on its cash accounts
and management believes, based upon the quality of the financial institutions, that the credit risk regarding these deposits is not significant. The
Company is dependent on third-party manufacturers to supply products for research and development activities in its programs. In particular,
the Company relies and expects to continue to rely on a small number of manufacturers to supply its requirements for supplies and raw
materials related to these programs. These programs could be adversely affected by a significant interruption in these manufacturing
services or the availability of raw materials.
(d) Cash
Cash consists primarily of
highly liquid investments with original maturities of three months or less at date of purchase to be cash equivalents. The Company had
no cash equivalents or restricted cash on March 31, 2023 and December 31, 2022.
(e) Impairment of long-lived assets
Long-lived assets consist
of property, plant and equipment, and intangible assets. Long-lived assets to be held and used are tested for recoverability whenever
events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that
the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation
to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets.
An impairment loss would be recognized as a loss from operations when estimated undiscounted future cash flows expected to result from
the use of an asset group or the estimated return on investment are less than its carrying amount. The impairment loss would be based
on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flow or return
on investment calculations.
(f) Accumulated other comprehensive income
(loss)
Accumulated other comprehensive
income (loss) includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic
events other than those with shareholders. The Company records unrealized gains and losses related to foreign currency translation and
instrument specific credit risk as components of other accumulated comprehensive income (loss) in the condensed consolidated statements
of operations and comprehensive loss. During the three months ended March 31, 2023 and 2022, the Company recorded accumulated foreign
currency translation gains (losses) of $ 84 and ($ 214 ), respectively.
(g) Contingencies
Liabilities for loss contingencies
arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has
been incurred and the amount can be reasonably estimated. At each reporting date, the Company evaluates whether a potential loss amount
or a potential loss range is probable and reasonably estimable under the provisions of the authoritative guidelines that address accounting
for contingencies. The Company expenses costs as incurred in relation to such legal proceedings as general and administrative expense
within the condensed consolidated statements of operations and comprehensive loss.
9
(h) Recently Issued Accounting Pronouncements
Changes to GAAP are established
by the FASB in the form of accounting standards updates (“ASUs”) to the FASB’s Accounting Standards Codification. The
Company considers the applicability and impact of all ASUs. All other ASUs issued through the date of these financial statements were
assessed and determined not to be applicable or are expected to have minimal impact on the Company’s condensed consolidated financial
position and results of operations.
3. Other Current Assets
The Company’s other
current assets are comprised of the following:
March 31,
2023
December 31,
2022
Deposits
$ 57
$ 51
Salary deposit
82
85
Value added tax (“VAT”) receivable
44
82
Deferred consulting costs
—
81
Deferred Directors & Officers insurance expense
884
1,260
$ 1,067
$ 1,559
4. Investment
The Company owned 43,898
common shares in Lantern Pharma Inc. (“Lantern Pharma”) because of a prior license agreement made with Lantern Pharma in
2017. During June 2020 Lantern Pharma became publicly listed. As of March 31, 2022, the fair value of the shares was $ 314 . In the
three months ended March 31, 2022, the Company recognized a loss on its shares in Lantern Pharma of $ 36 . During July 2022, the Company
sold its 43,898 common shares in Lantern Pharma in exchange for net proceeds of $ 235 and recognized a loss of $ 115 .
5. Intangible assets
During the quarter ended
March 31, 2023, because of continuing downward pressure on the Company’s common stock, we performed an impairment assessment
with a WACC of 26 % and determined that no further impairment of our intangible assets is required as of March 31, 2023.
As a result of both the Company’s
February 15, 2022, receipt of a Refusal to File (“RTF”) from the U.S. Food and Drug Administration regarding the Company’s
new drug application (“NDA”) for Dovitinib, and the current depressed state of the Company’s stock price, the Company
has performed an impairment assessment on its individual intangible assets utilizing a discounted cash flow model with a weighted average
cost of capital (“WACC”) of 16 %, and recognized an impairment charge of $ 14,007 during the quarter ended March 31, 2022.
During the quarter ended December 31, 2022, as a result of continued downward pressure on the Company’s common stock, we performed
a further impairment assessment on the Company’s individual intangible asset utilizing a discounted cash flow model with a WACC
of 26 % and recognized a further impairment charge of $ 3,564 .
The Company’s IPR&D
assets have been classified as indefinite-lived intangible assets. Our individual material development project in progress, Stenoparib,
is recorded at $ 9,711 and $ 9,549 on March 31, 2023 and December 31, 2022, respectively.
10
6. Accrued liabilities
The Company’s accrued
liabilities are comprised of the following:
March 31,
2023
December 31,
2022
Development cost liability (Notes 16(a) and (b))
$ 1,514
$ 964
Payroll accruals
97
221
Accrued Board member fees
58
91
Accrued audit and legal
649
239
Other
33
389
$ 2,351
$ 1,904
7. Convertible promissory note and accrued interest, net
On April 12, 2022, Allarity
Denmark re-issued a Convertible Promissory Note (the “Promissory Note”) to Novartis Pharma AG, a company organized under
the laws of Switzerland (“Novartis,” and together with Allarity Therapeutics Europe ApS (“Allarity Europe”),
the “License Parties”) in the principal amount of $ 1,000 . The Promissory Note was re-issued pursuant to the First Amendment
to License Agreement, with an effective date of March 30, 2022 (the “First Amendment”), entered into by and between the License
Parties, which amended the License Agreement dated April 6, 2018 (the “Original Agreement”) previously entered into
by the License Parties relating to the Compound (as defined in the Original Agreement). The First Amendment amends and restates Section
11.7 of the Original Agreement to add the revised Note to the list of enforceable claims in the second paragraph of Section 11.7 making
the revised Note enforceable under New York law as a legal obligation of Allarity Denmark ApS (formerly OV-SPV2 ApS). All other provisions
of the Original Agreement and Promissory Note were unchanged and remain in full force and effect.
The Promissory Note pays
simple interest on the outstanding principal amount from the date until payment in full, which interest shall be payable at the rate
of 5 % per annum. Interest shall be calculated on the basis of a 360-day year for the actual number of days elapsed. The entire outstanding
principal balance of the Promissory Note and all accrued interest shall be fully due and payable on the Maturity Date. The Promissory
Note is convertible upon an initial public offering (“IPO”) of Allarity Therapeutics Denmark ApS and allows Novartis a one-time
right to exchange the Convertible Pro Allarity Therapeutics Denmark ApS Promissory Note for such number of equity securities of Allarity
Therapeutics Denmark ApS equal to 3 % of outstanding equity securities, calculated on a fully diluted as-converted to common stock basis,
held by all holders of equity securities of Allarity Therapeutics Denmark ApS immediately prior to the closing of the IPO.
During the three-month periods
ended March 31, 2023 and 2022, the Company recorded $ 27 and $ 26 , respectively to interest expense and increased the convertible promissory
note liability by the same amount. The roll forward of the Promissory Note as of March 31, 2023, and December 31, 2022, is as follows:
March 31,
2023
December 31,
2022
Convertible promissory note
$ 1,000
$ 1,000
Less debt discount, opening
( 162 )
( 215 )
Plus, accretion of debt discount, interest expense
12
53
Convertible promissory note, net of discount
850
838
Interest accretion, opening
245
194
Interest accrual, expense
15
51
Convertible promissory note – net, ending balance
$ 1,110
$ 1,083
11
8. Convertible debt
3i, LP Convertible Secured Promissory Notes
On
November 22, 2022, the Company entered into a Secured Note Purchase Agreement (“Purchase Agreement”) with 3i, LP (“Holder”,
or “3i”), whereby the Company authorized the sale and issuance of three Secured Promissory Notes (each a “Note”
and collectively, the “Notes”). Effective November 28, 2022, the Company issued: (1) a Note in the principal amount of $ 1,667
as payment of $ 1,667 due to 3i, LP in Alternative Conversion Floor Amounts that began to accrue on July 14, 2022; and (2) a Note in the
principal amount of $ 350 in exchange for cash. Effective December 30, 2022, the Company issued an additional Note in the principal amount
of $ 650 in exchange for cash.
Each
Note matures on January 1, 2024, carries an interest rate of 5 % per annum, and is secured by all of the Company’s assets pursuant
to a security agreement (the “Security Agreement”). In addition, the Holder may exchange the Notes for the Company’s
common stock at an exchange price equal to the lowest price per share of the equity security sold to other purchasers, rounded down to
the nearest whole share, if the Company concludes a future equity financing prior to the maturity date or other repayment of such promissory
note. Lastly, each Note and interest earned thereon may be redeemed by the Company at its option at any time or the holder may demand
redemption if a) the Company obtains gross proceeds of at least $ 5 million in a financing in an amount of up to 35 % of the gross proceeds
of the financing or b) there is an Event of Default (as defined in the Note agreement).
Discounts to the principal
amounts are included in the carrying value of the Notes and amortized to interest expense over the contractual term of the underlying
debt. During 2022, the Company recorded a $ 34 debt discount upon issuance of the Notes related to legal fees paid that were capitalized
as debt issuance costs. For the three month period ended March 31, 2023, interest expense totaled $ 43 , comprised of $ 33 for contractual
interest and $ 10 for the amortization of the debt discount.
The roll forward of the Notes
as of March 31, 2023, and December 31, 2022, is as follows:
March 31,
2023
December 31,
2022
Convertible promissory note
$ 2,667
$ 2,667
Less debt discount, opening
( 32 )
( 34 )
Plus, accretion of debt discount, interest expense
10
2 )
Carrying value of the Convertible Notes
2,645
2,635
Interest accretion, opening
9
—
Interest accrual, expense
33
9
Convertible promissory note – net, ending balance
$ 2,687
$ 2,644
Subsequent to March 31, 2023,
the 3i Convertible Secured Promissory Notes were paid in full and cancelled on April 21, 2023. See Note 18(b).
9. Preferred Stock
A. Series A Convertible Preferred Stock and Common Stock Purchase
Warrants
(a) Amendments to Series A Convertible Preferred Stock
i.
Voting Rights
On November 22, 2022, the
Company amended Section 12 of the Certificate of Designation of Series A Convertible Preferred Stock (“Series A Preferred Stock”)
to provide for voting rights. Subject to a 9.99 % beneficial ownership limitation, the holders of Series A Preferred Stock shall have
the right to vote on all matters presented to the stockholders for approval together with the shares of common stock, voting together
as a single class, on an “as converted” basis using the “Conversion Price” (initially $ 9.906 per share before
any adjustment) (rounded down to the nearest whole number and using the record date for determining the stockholders of the Company eligible
to vote on such matters), except as required by law (including without limitation, the DGCL) or as otherwise expressly provided in the
Company’s Certificate of Incorporation or the Certificate of Designations of Series A Convertible Preferred Stock. The voting rights
described above shall expire on February 28, 2023, and thereafter holders of preferred stock shall not have voting rights except as required
by law.
12
ii.
Conversion Price Adjustment
for Series A Preferred Stock
On December 9, 2022, the
Company and 3i entered into a letter agreement which provided that pursuant to Section 8(g) of the Certificate of Designations for the
Series A Preferred Stock, the parties agreed that the Conversion Price was modified to mean the lower of: (i) the Closing Sale Price
on the trading date immediately preceding the Conversion Date and (ii) the average Closing Sale Price of the common stock for the five
trading days immediately preceding the Conversion Date, for the Trading Days through and inclusive of January 19, 2023. Any conversion
which occurs shall be voluntary at the election of the Holder, which shall evidence its election as to the Series A being converted in
writing on a conversion notice setting forth the then Minimum Price. Management determined that the adjustment made to the Conversion
Price is not a modification of the COD which allows for adjustments to the Conversion Price at any time by the Company and the other
terms of the Certificate of Designations remained unchanged. Subsequent to March 31, 2023, the terms of the Series A Preferred Stock
have been further amended. See Note 18(c).
(b) Series A Preferred Stock Triggering Event
As more specifically discussed
below, a “Triggering Event” under the COD occurred on April 29, 2022, under Section 5(a)(ii) of the COD, which would have
resulted in the following unless 3i, agreed to forebear and/or waive its rights under the COD:
1. An 18 % per annum dividend
will start to accrue on the stated value of all outstanding Preferred Shares and will continue to accrue until the Triggering Event has
been cured. The accrued dividend is added to the stated value prior to the Dividend Payment Date and paid in cash on the first trading
day of the Company’s next fiscal quarter. A “Late Charge” in the amount of 18 % per annum will accrue on any amounts
due to be paid to holders of the Preferred Shares if not paid when due, including payments that may be owed under Section (e) of the
Registration Rights Agreement (“RRA”).
2. A “Triggering Event
Redemption Right” will commence and remain open for a period of 20 trading days from the later of the date either the Triggering
Event is cured or the receipt by 3i of the Triggering Event Notice. Under the Triggering Event Redemption Right, if elected by the holder
of the Preferred Shares, the Company would be obligated to redeem all or a portion of the Preferred Shares for a minimum of 125 % of the
stated value of the Preferred Shares. Concurrently, under the provisions of the PIPE Warrant, if elected by 3i, the Company would be
obligated to redeem the PIPE Warrant for the Black Sholes Triggering Event Value as defined in the warrant agreement.
3. A “Registration
Delay Payment” will accrue on April 22, 2022 (the expiration of the Allowable Grace Period under the RRA) in the amount of 2 % of
3i’s “Purchase Price” as defined in the Securities Purchase Agreement which is approximately 2 % of $ 20 million, or
$ 400 and will continue to accrue at 2 % every 30 days thereafter. Additionally, a late charge of 2 % per month will accrue on any payments
that are not paid when due. The Registration Delay Payments will stop accruing when the post-effective amendment is declared effective
by the SEC at which time the registration statement and its prospectus will again be available for the resale of common stock.
On May 4, 2022, the Company
and 3i entered into a Forbearance Agreement and Waiver, dated April 27, 2022, wherein 3i confirmed that no Triggering Event as defined
under the COD has occurred prior to April 27, 2022, that a Triggering Event under Section 5(a)(ii) will and has occurred on April 29,
2022, and that in consideration for the Registration Delay Payments the Company is obligated to pay under the RRA, and additional amounts
the Company is obligated to pay under the COD and 3i’s legal fees incurred in the preparation of the Forbearance Agreement and
Waiver in the aggregate of $ 539 paid upon execution of the Forbearance Agreement and Waiver, and so long as the Company pays the Registration
Delay Payments that become due and payable under the RRA after the execution of the Forbearance Agreement and Waiver, 3i has agreed to
forbear exercising any rights or remedies that it may have under the COD that arises as a result of a Triggering Event under Section
5(a)(ii) of the COD and Section 4(c)(ii) of the PIPE Warrant until the earlier to occur of (i) the date immediately prior to the date
of occurrence of a Bankruptcy Triggering Event, (ii) the date of occurrence of any other Triggering Event under Section 5(a) of the COD
(excluding any Triggering Event arising solely as a result of Section 5(a)(ii) of the COD and Section 4(c)(ii) of the PIPE Warrant),
(iii) the time of any breach by the Company under the Forbearance Agreement and Waiver, (iv) the Resale Availability Date as defined
therein and (v) June 4, 2022 (such period, the “Forbearance Period”). Provided that the Company is not in breach of its obligations
under Forbearance Agreement and Waiver, effective as of the Trading Day immediately following the date the Company cures the Triggering
Event under Section 5(a)(ii) of the COD, 3i agrees to waive any rights or remedies that it may have under the COD that arises as a result
of a Triggering Event under Section 5(a) of the COD and Section 4(c)(ii) of the PIPE Warrant that may have arisen prior to the date of
the Forbearance Agreement and Waiver.
13
(c) 3i Warrants
Effective April 21, 2023,
pursuant to the terms of a Modification and Exchange Agreement, the 3i Warrants were exchanged for 12,603,835 warrants at an exercise
price of $ 0.75 per share. See Note 18(b).
(d) Accounting
i.
Series A Preferred Stock
The Company evaluated the
Series A Preferred Stock under ASC 480-10 to determine whether it represents an obligation that would require the Company to classify
the instrument as a liability and determined that the Series A Preferred Stock is not a liability pursuant to ASC 480-10. Management
then evaluated the instrument pursuant to ASC 815 and determined that because the holders of the Series A Preferred Stock may be entitled
to receive cash, the Series A Preferred stock should be recorded as mezzanine equity given the cash redemption right that is within the
holder’s control.
Generally, preferred stock
that are currently redeemable should be adjusted to their redemption amount at each balance sheet date. If it is probable that the equity
instrument will become redeemable, the Company has the option to either accrete changes in the redemption value over the
period from the date of issuance (or from the date that it becomes probable that the instrument will become redeemable, if later) to
the earliest redemption date of the instrument or to recognize changes in the redemption value immediately as they occur
and adjust the carrying amount of the instrument to equal the redemption value at the end of each
reporting period. The Company recognizes changes in redemption value when redemption becomes probable to occur.
Through December 9,
2022, the derivative scope exception under ASC 815 was not met because a settlement contingency was not indexed to the Company’s
stock. Therefore, the redemption feature (derivative liability) was bifurcated from the Series A Preferred Stock and recorded as a derivative
liability. The fair value of the Series A Preferred Stock Redemption Feature (the “Redemption Feature”) derivative is the
difference between the fair value of the Series A Preferred Stock with the Redemption Feature and the Series A Preferred Stock without
the Redemption Feature. The Series A Preferred Stock Redemption Feature has been valued with a Monte Carlo Simulation model, using the
inputs as described in Note 10(b).
Subsequent to December 9,
2022, because of the agreed conversion price adjustment (see Note 9.A(b)ii.), although bifurcation of the conversion feature is still
required, the value of the derivative has been determined to be immaterial since the conversion price will always be at market.
ii.
Modification to Conversion
Price of Series A Preferred Stock
On January 23, 2023, we and
3i, LP amended the letter agreement entered into on December 8, 2022, to provide that the modification of the term Series A Preferred
Stock Conversion Price (“Series A Preferred Stock Conversion Price”) to mean the lower of: (i) the Closing Sale Price (as
defined in the Certificate of Designations of Series A Preferred Stock (“Series A Certificate of Designations”)) on the trading
date immediately preceding the Conversion Date (as defined in the Series A Certificate of Designations and (ii) the average Closing Sale
Price of the common stock for the five trading days immediately preceding the Conversion Date, for the Trading Days (as defined in the
Series A Certificate of Designations) will be in effect until terminated by us and 3i, LP.
iii.
3i Warrants
The 3i Warrants were identified
as a freestanding financial instrument and meet the criteria for derivative liability classification, initially measured at fair value.
Subsequent changes in fair value are recognized through earnings for as long as the contracts continue to be classified as a liability.
The measurement of fair value is determined utilizing an appropriate valuation model considering all relevant assumptions current at
the date of issuance and at each reporting period (i.e., share price, exercise price, term, volatility, risk-free rate and expected dividend
rate).
(f) Series A Preferred Stock Conversions
i.
Three month period ended March 31, 2023
During the three month period
ended March 31, 2023, 3i exercised its option to convert 3,838 shares of Series A Preferred stock for 721,462 shares of common stock
at the fair value of $ 565 . As of March 31, 2023, we had 9,748 shares of Series A Preferred Stock issued and outstanding. See Note 18(b).
14
ii.
Three month period ended March 31, 2022
Between January 1, 2022, and
March 31, 2022, a total of 1,973 Series A Preferred Stocks were converted into 746,276 shares of our common stock, thereby reducing outstanding
Series A Preferred Stocks at March 31, 2022 to 17,827 . The fair value of the derivative liability associated with the Series A Preferred
Stock converted during the three month period ended March 31, 2022, as determined by Monte Carlo simulations, was $ 452 . Because the latest
three conversions in March 2022 were completed at less than the agreed floor price, we recorded a floor price liability of $ 134 within
accrued liabilities and recognized a $ 134 reduction of additional paid in capital. Additionally, because the Company’s average daily
dollar volume of stock trading was less than $ 2.5 million during a ten-day period in January 2022, the Company has recorded a one-time
deemed dividend of 8 % in the amount of $ 1,572 on preferred stock converted between February 1, 2022 and March 31, 2022 and the balance
of preferred stock outstanding as at March 31, 2022 as an increase to the value of the convertible preferred stock and a reduction of
additional paid in capital.
The accounting for the Series
A Convertible Preferred Stock and Warrants is illustrated in the table below:
Consolidated Balance Sheets
Consolidated
Statement of
Operations &
Comprehensive
Loss
Warrant
liability
Series A
Convertible
Preferred
Stock –
Mezzanine
Equity
Common
Stock
Additional
paid-in
capital
Fair value
adjustment to
derivative and warrant
liabilities
Balances at December 31, 2022
$ 374
$ 2,001
$ —
$ ( 3,756 )
$ —
Conversion of 3,838 Series A Preferred Stock, net
—
( 575 )
—
575
—
Fair value adjustment at March 31, 2023
( 309 )
—
—
—
309
$ 65
$ 1,426
$ —
$ ( 3,181 )
$ 309
Consolidated Balance Sheets
Consolidated
Statement of
Operations &
Comprehensive
Loss
Warrant
liability
Series A
Preferred
Derivative
Liability
Series A
Convertible
Preferred
Stock –
Mezzanine
Equity
Common
Stock
Additional
paid-in
capital
Accrued
Liabilities
Fair value
adjustment to
derivative and warrant
liabilities
Balances at December 31, 2021
$ 11,273
$ 7,181
$ 632
$ 2
$ 80
$ —
$ —
Conversion of 1,973 Series A Preferred Stock, net
—
( 452 )
( 62 )
75
306
134
—
8% Deemed dividend on Preferred Stock
—
—
1,572
—
( 1,572 )
—
—
Fair value adjustment at March 31, 2022
( 9,008 )
( 3,558 )
—
—
—
—
12,566
$ 2,265
$ 3,171
$ 2,142
$ 77
$ ( 1,186 )
$ 134
$ 12,566
15
B. Series C Convertible Preferred Stock
On February 28, 2023, the
Company entered into a Securities Purchase Agreement (the “SPA”) with 3i, L.P. for the purchase and sale of 50,000 shares
of Series C Convertible Redeemable Preferred Stock (“Series C Preferred Stock”) at a purchase price of $ 24.00 per share,
for a subscription receivable in the aggregate amount equal to the total purchase price of $ 1.2 million (the “Offering”).
The 50,000 shares of Series C Preferred Stock (the “Shares”) are convertible into shares of the Company’s common stock,
subject to the terms of the COD. The conversion price for the Series C Preferred Stock is initially equal the lower of: (i) $0.182 ($6.37
post reverse stock split) , which is the official closing price of the Common Stock on the Nasdaq Global Market (as reflected on Nasdaq.com)
on the Trading Day (as defined in the COD) immediately preceding the Original Issuance Date (as defined in the COD); and (ii) the lower
of: (x) the official closing price of the Common Stock on the Nasdaq Global Market (as reflected on Nasdaq.com) on the Trading Day immediately
preceding the Conversion Date or such other date of determination; and (y) the average of the official closing prices of the Common Stock
on the Nasdaq Global Market (as reflected on Nasdaq.com) for the five Trading Days immediately preceding the Conversion Date (as defined
in the COD) or such other date of determination, subject to adjustment (the “Conversion Price”). In no event will the Conversion
Price be less than $ 0.0370 ($ 1.295 post reverse stock split) (the “Floor Price”). In the event that the Conversion Price
on a Conversion Date would have been less than the applicable Floor Price if not for the immediately preceding sentence, then on any
such Conversion Date the Company will pay the Holder an amount in cash, to be delivered by wire transfer out of funds legally and immediately
available therefor pursuant to wire instructions delivered to the Company by the Holder in writing, equal to the product obtained by
multiplying (A) the higher of (I) the highest price that the Common Stock trades at on the Trading Day immediately preceding such Conversion
Date and (II) the applicable Conversion Price and (B) the difference obtained by subtracting (I) the number of shares of Common Stock
delivered (or to be delivered) to the Holder on the applicable Share Delivery Date with respect to such conversion of Series C Preferred
Stock from (II) the quotient obtained by dividing (x) the applicable Conversion Amount that the Holder has elected to be the subject
of the applicable conversion of Series C Preferred Stock, by (y) the applicable Conversion Price without giving effect to clause (x)
of such definition. The Offering closed on February 28, 2023.
In connection with the Offering,
concurrently with the SPA, the Company entered into a registration rights agreement with 3i (the “RRA”) pursuant to which
the Company is required to file a registration statement with the SEC to register for resale the shares of Common Stock that are issued
upon the potential conversion of the Shares. Under the terms of the RRA, if the Company fails to file an Initial Registration Statement
(as defined in the RRA) on or prior to its Filing Date (as defined in the RRA), or fail to maintain the effectiveness of the registration
statement beyond defined allowable grace periods set forth in the RRA, we will incur certain registration delay payments, in cash and
as partial liquidated damages and not as a penalty, equal to 2.0 % of 3i’s subscription amount of the Shares pursuant to the SPA.
In addition, if we fail to pay any partial liquidated damages in full within seven days after the date payment, we will have to pay interest
at a rate of 18.0 % per annum, accruing daily from the date such partial liquidated damages are due until such amounts, plus all such
interest thereon, are paid in full. The Company has also agreed to pay all fees and expenses incident to the performance of the RRA,
except for any broker or similar commissions. In connection with the Offering, the Company and 3i entered into a limited waiver agreement
(the “Waiver”) pursuant to which 3i confirmed that the sale and issuance of the Shares will not give rise to any, or trigger
any, rights of termination, defaults, amendment, anti-dilution or similar adjustments, acceleration or cancellation under agreements
with 3i.
The Company has evaluated
the terms of the Series C Preferred Stock as required pursuant to ASC 570, 480, 815 and ASU 2020-06, and concluded the Series C Preferred
Stock will be recorded at fair value of $1,200, net of share issuance costs of $40, and accreted to redemption value of $1,485 on April
21, 2023, using the effective interest method. The Company will also accrue dividends of 5%. The roll forward of the Series C Preferred
Stock as of March 31, 2023, is as follows:
March 31,
2023
Series C Preferred Stock, cash received
$ 1,200
Less debt discount, opening
( 40 )
Plus, 5 % dividend and accretion
167
Series C Preferred Stock – net, ending balance
$ 1,327
Effective April 21, 2023,
all of the 50,000 shares of Series C Preferred stock were exchanged for Series A Preferred Stock. See Note 18(b).
16
10. Derivative Liabilities
(a) Continuity of 3i Warrant Liability and Series A Redemption
Feature Derivative Liabilities
The 3i Warrant and Series
A redemption feature derivative liabilities are measured at fair value at each reporting period and the reconciliation of changes in
fair value in the three month period ended March 31, 2023, and the year ended December 31, 2022, is presented in the following table:
3i Warrants
3i Fund
Series A
Redemption
Feature
Issued December 20, 2021
Balance as of January 1, 2022
$ 11,273
$ 7,181
Change in fair value
( 10,899 )
( 6,227 )
Amount transferred to Equity
—
( 954 )
Balance as of December 31, 2022
$ 374
$ —
Fair value per 3i Warrant / Series A Preferred Stock issuable at period end
$ 6.48
$ —
Balance as of January 1, 2023
$ 374
$ —
Change in fair value
( 309 )
—
Balance as of March 31, 2023
$ 65
$ —
Fair value per 3i Warrant / Series A Preferred Stock issuable at period end
$ 1.13
$ —
(b) 3i Warrants – Valuation Inputs
On March 31, 2023 and 2022,
the Company utilized the reset strike options Type 2 model by Espen Garder Haug and Black-Scholes Merton models to estimate the fair
value of the 3i Warrants to be approximately $ 65 and $ 2,265 respectively. The 3i Warrants were valued at March 31, 2023 and 2022, using
the following inputs:
March 31,
2023
March 31,
2022
Initial exercise price
$ 9.91
$ 9.91
Stock price on valuation date
$ 1.68
$ 2.04
Risk-free rate
4.13 %
2.40 %
Expected life of the Warrant to convert (years)
1.73
2.73
Rounded annual volatility
175 %
110 %
Timing of liquidity event
Q2 2023
Q4 2022 –
Q1 2023
Expected probability of event
90 %
90 %
The shares of Series A Preferred
Stock converted in the three month period ended March 31, 2023 were recorded at $ 565 . The following inputs were used for the Series A
Preferred Stock conversions recorded in the three month period ended March 31, 2022 and the fair value of the Series A Preferred Derivative
liability determined at March 31, 2022:
January 1, 2022 –
March 31, 2022
Initial exercise price
$ 9.90
Stock price on valuation date
$ 1.93 - $ 10.75
Risk-free rate
1.03 % - 2.40 %
Time to exercise (years)
2.72 – 2.96
Equity volatility
70 %- 90 %
Probability of volume failure
93 % - 99 %
Rounded 10-day average daily volume (in 1,000’s)
332 - 873
17
11. Stockholders’ Equity
(a) Amendment to Certificate of Incorporation
On March 20, 2023, an amendment
to Allarity Therapeutics, Inc.’s Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to
increase the number of authorized shares from 30,500,000 to 750,500,000 , and to increase the number of shares of common stock (the “Common
Stock”) from 30,000,000 to 750,000,000 (the “Share Increase”) was approved by the stockholders of record entitled to
vote in person or by proxy at the Special Meeting of Stockholders on March 20, 2023 (the “2023 Special Meeting”). Upon receipt
of the required stockholder approval, on March 20, 2023, Allarity Therapeutics, Inc. (the “Company”), filed a Second Certificate
of Amendment to the Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of State of the State
of Delaware (the “Delaware Secretary of State”) to effect the Share Increase.
As a result of the filing
of the Certificate of Amendment, the Company is authorized to issue 750,500,000 shares, consisting of (i) 750,000,000 shares of common
stock, par value $0.0001 per share, and (ii) 500,000 shares of preferred stock, par value of $0.0001 per share.
(b) Redemption of Series B Preferred Stock
Upon conclusion of the 2023
Annual Meeting of Stockholders on February 3, 2023, all the 190,786 shares of Series B Preferred Stock outstanding were automatically
redeemed, with the holders of the Series B Preferred Stock only having a right to receive the purchase price for the redemption, which
was $ 0.01 per share of Series B Preferred Stock.
(c) Series C Preferred Stock
On February 24, 2023, the
Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Redeemable Preferred Stock
(the “Series C COD”) with the Delaware Secretary of State designating 50,000 shares of its authorized and unissued preferred
stock as Series C Preferred Stock with a stated value of $ 27.00 per share. On February 28, 2023, the Company filed a Certificate of Amendment
to the Series C COD (the “COD Amendment”) to clarify the terms of conversion price and floor price based on definitions provided
in the Series C COD (the COD Amendment, together with the Series C COD, the “COD”). Each share of Series C Preferred Stock
has 620 votes and is subject to certain redemption rights and voting limitations. See Note 18(c).)
Pursuant to the terms of a
Modification and Exchange Agreement dated April 20, 2023 by and between 3i and the Company, effective April 21, 2023, 3i exchanged 50,000
shares of Series C Preferred Stock (the “Series C Shares”) beneficially owned by 3i for 4,027 shares of Series A Preferred
Stock. See Note 18(b).
(d) Reverse Stock-split
On March 20, 2023, an amendment
to the Company’s Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to increase the number
of authorized shares from 30,500,000 to 750,500,000 , and to increase the number of shares of common stock (the “Common Stock”)
from 30,000,000 to 750,000,000 (the “Share Increase”) was approved by the stockholders of record entitled to vote in person
or by proxy at the Special Meeting of Stockholders. Upon receipt of the required stockholder approval, on March 20, 2023, the Company
filed the Certificate of Amendment with the Delaware Secretary of State to effect the Share Increase. On March 23, 2023, the Company
filed a Third Certificate of to the Certificate of Incorporation with the Delaware Secretary of State to effect a 1-for-35 share consolidation
of our common stock on March 24, 2023 (“Share Consolidation”). No fractional shares were issued in connection with the Share
Consolidation. If, as a result of the Share Consolidation, a stockholder would otherwise have been entitled to a fractional share, each
fractional share was rounded up to the next whole number. The Share Consolidation resulted in a reduction of our outstanding shares of
common stock from 34,294,582 to 979,846 . As a result of the Second Certificate of Amendment of our Certificate of Incorporation as discussed
above, the number of our authorized shares is 750,500,000 which consist of 750,000,000 authorized shares of Common Stock and 500,000
authorized shares of preferred stock. The par value of our authorized stock remained unchanged at $0.0001. As of the date of these financial
statements all references to our common stock have been retrospectively adjusted to reflect the one for thirty-five shares, unless otherwise
noted.
(e) Share issuances
During the three months ended
March 31, 2023, the Company issued 721,462 shares of common stock valued at $ 565 upon the conversion of 3,838 shares of Series A Preferred
stock. During the three months ended March 31, 2022, the Company issued 21,322 shares of common Stock valued at $ 381 , net of the $ 134
floor price adjustment payable, upon the conversion of 1,973 shares of Series A Preferred Stock.
18
12. Stock-based payments
During the three months ended
March 31, 2023 and 2022, total stock-based payment (recoveries) / expenses recorded in the condensed consolidated statement of operations
and comprehensive loss were ($ 121 ) and $ 1,065 , respectively of which ($ 80 ) and ($ 41 ) are recognized as general and administrative and
research and development expense recoveries respectively in the three months ended March 31, 2023, and March 31, 2022, $ 703 were recognized
as general and administrative and $ 362 as research and development expenses, respectively. Total compensation cost for non-vested warrants
as at March 31, 2023 is $ 524 and is expected to be realized over a period of 2.50 years.
A summary of stock option
activity under the Company’s stock option plans during the three-month period ended March 31, 2023, is presented below:
Options Outstanding
Number of
Shares
Weighted
Average
Exercise
Price Share
Weighted
Average
Life (in years)
Outstanding December 31, 2022
19,332
$ 229.36
4.14
Cancelled or expired
( 1,765 )
342.56
—
Outstanding as of March 31, 2023
17,567
$ 213.74
3.86
Options exercisable at March 31, 2023
11,804
$ 242.97
3.95
During the three month period
ended March 31, 2023, no options were granted. During the three month period ended March 31, 2022, no options were granted, exercised,
expired, or cancelled.
13. Segments
The Company is domiciled
in the United States of America and its operations are in Denmark and operates as one operating segment. Our Chief Executive Officer
(CEO), as the chief operating decision-maker, manages and allocates resources to the operations of our Company on a total Company basis. Managing
and allocating resources on a total company basis enables our CEO to assess the overall level of resources available and how to best
deploy these resources across functions, therapeutic areas and research and development projects that are in line with our long-term
company-wide strategic goals. Consistent with this decision-making process, our CEO uses consolidated, single-segment financial information
for purposes of evaluating performance, forecasting future period financial results, allocating resources, and setting incentive targets.
The Company has neither revenues from external customers outside Denmark, nor long-term assets in geographical areas other than Denmark.
14. Loss per share of common stock
Basic loss per share is derived
by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each
period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as warrants
and stock options, which would result in the issuance of incremental shares of common stock unless such effect is anti-dilutive. In calculating
the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remained the same for
both calculations because when a net loss exists, dilutive shares are not included in the calculation. Potentially dilutive securities
outstanding, as determined by the latest applicable conversion price, that have been excluded from diluted loss per share due to being
anti-dilutive include the following:
March 31,
March 31,
2023
2022
Warrants and stock options
75,252
91,256
Series A Convertible Preferred stock
151,829
277,655
Series C Convertible Preferred stock
38,610
—
Convertible debt
1,587,500
—
1,853,191
368,911
19
15. Financial Instruments
The following tables present
information about the Company’s financial instruments measured at fair value on a recurring basis and indicate the level of the
fair value hierarchy used to determine such fair values:
Fair Value Measurements as of March 31, 2023, Using:
Level 1
Level 2
Level 3
Total
Liabilities:
Warrant liability
$ —
$ —
$ ( 65 )
$ ( 65 )
$ —
$ —
$ ( 65 )
$ ( 65 )
Fair Value Measurements as of December 31, 2022, Using:
Level 1
Level 2
Level 3
Total
Liabilities:
Warrant liability
$ —
$ —
$ ( 374 )
$ ( 374 )
$ —
$ —
$ ( 374 )
$ ( 374 )
Methods used to estimate
the fair values of our financial instruments, not disclosed elsewhere in these financial statements, are as follows:
When available, our marketable
securities are valued using quoted prices for identical instruments in active markets. If we are unable to value our marketable securities
using quoted prices for identical instruments in active markets, we value our investments using broker reports that utilize quoted market
prices for comparable instruments. We have no financial assets or liabilities measured using Level 2 inputs. Financial assets and liabilities
are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies, or similar techniques,
and at least one significant model assumption or input is unobservable.
The Company recognizes its
derivative liabilities as level 3 and values its derivatives using the methods discussed below. While the Company believes that its valuation
methods are appropriate and consistent with other market participants, it recognizes that the use of different methodologies or assumptions
to determine the fair value of certain financial instruments could result in a different estimate of fair value at the reporting date.
The primary assumptions that would significantly affect the fair values using terms in the notes that are subject to volatility and market
price of the underlying common stock of the Company.
The Company reviews the fair
value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification
of levels for certain securities within the fair value hierarchy. The Company’s policy is to recognize transfers into and out of
levels within the fair value hierarchy at the date the actual event or change in circumstances that caused the transfer occurs. When
a determination is made to classify an asset or liability within Level 3, the determination is based upon the significance of the unobservable
inputs to the overall fair value measurement. There were no transfers between level 1 or level 2 during the three-month periods ended
March 31, 2023 and 2022.
16. Income Taxes
The effective tax rate for
the three-month periods ended March 31, 2023 and 2022, was impacted by unbenefited losses. Specifically, the March 31, 2022, impairment
charge of approximately $ 14,000 has resulted in a tax benefit of $ 1,227 in the three months ended March 31, 2022.
20
17. Commitments and Contingencies
(a) Second Amendment to License Agreement with Novartis for Dovitinib
On September 27, 2022,
Allarity Europe, entered into a Second Amendment to License Agreement with Novartis, which amended the terms of the Original Agreement,
as amended by that certain First Amendment to License Agreement effective as of March 30, 2022 and that certain Promissory Note dated
April 6, 2018, which was re-issued by Allarity Therapeutics Denmark ApS, a subsidiary of Allarity Europe, in favor of Novartis on March
30, 2022, to modify the terms and timing of the Outstanding Milestone Payment (as defined in the Second Amendment), including an increase
in such milestone payment by $ 500 , in addition to the $ 5,000 which is included in accounts payable at September 30, 2022. The Second
Amendment became effective upon receipt by Novartis of the first portion of the Outstanding Milestone Payment ($ 1,000 ), which was paid
on or about September 28, 2022.
Under Clause 7.2 of the
Original Agreement, the Company agreed to pay Novartis a milestone payment in one lump sum (“Third Milestone Payment”) upon
submission of the first NDA with the FDA for a Licensed Product in the United States (the “Third Milestone”). The Second
Amendment restructured the terms of the Third Milestone Payment to an installment plan (with the final installment due in 2023), allowing
the Company more time to make the Third Milestone Payment.
In addition, the Second
Amendment amended (1) Clause 1.1 of the Agreement to include the definitions of Financing Transaction, Phase 1 Clinical Trial and Phase
1b/2 Clinical Trial, (2) Clause 2.1 of the Agreement to clarify that the Company would not be permitted to sublicense any rights granted
to the Company prior to completion of a Phase II Clinical Trial without the prior written consent of Novartis, and (3) Clause 7.3 to
provide for the acceleration of certain milestone payments in the event the Company enters into a Financing Transaction (as defined in
the Second Amendment). If all milestones under the Second Amendment are achieved, the Company may be obligated to pay Novartis up to
a maximum of $ 26,500 .
(b) Notice of Breach From Novartis Pharma AG
Pursuant to the agreement
with Novartis, through our wholly-owned subsidiary Allarity Europe, we have the right to use dovitinib used in combination with Stenoparib
to address the second-line or later treatment of metastatic ovarian cancer. Under the terms of the license agreement, we are required
to make certain milestone payments, including a payment of $ 1,500 , which was due on April 1, 2023. We did not make that milestone payment,
and on April 4, 2023, Novartis sent a notice of breach under the license agreement to Allarity Europe stating that it has 30 days from
April 4, 2023, to cure. As of April 28, 2023, Novartis has been paid $ 100 towards the current milestone payable of $ 1,500 .
(c) Third Amendment to Stenoparib Exclusive License Agreement with Eisai Inc.
Effective July 12, 2022
the Company’s July 6, 2017 Exclusive License Agreement with Eisai Inc. (as amended December 11, 2020 and August 3, 2021) (the “Third
Amendment”), the terms of the original exclusive license were further amended in order to (1) further postpone the due date of
the Extension Payment and extend the deadline for the Company’s successful completion of its first Phase 1b or Phase 2 clinical
trial for Stenoparib (the “Product”) beyond December 31, 2022; and (2) amend terms related to Eisai’s right of
termination of development.
In consideration of the
extended timeframe, and the Company not achieving the minimum patient enrollment, by July 1, 2022, set out in the Second Amendment, the
Company is obligated to pay Eisai an extension payment as follows:
(i)
$100 within 10 days of
the execution of the Third Amendment (paid during the period ended September 30, 2022); and
(ii)
$900 on or before April 1, 2023 (accrued at September 30, 2022). As of the date of this quarterly report, the $900 remains unpaid, however, management is currently in discussions with Eisai to extend the terms of payment.
Once the extension payment
is paid in full, the Company shall have until April 1, 2024, to complete enrollment in a further Phase 1b or Phase 2 Clinical Trial of
the Product. If the Company has not achieved successful completion of a further Phase 1b or Phase 2 Clinical Trial of the Product prior
to April 1, 2024, Eisai may terminate this Agreement in its entirety, in its sole discretion on at least 120 days prior written notice.
(d) Development costs and Out-License Agreement with Smerud
Under the terms of the
June 2020 Sublicense agreement (the “2022 Sublicense Agreement”) between the Company and Smerud Medical Research International
AS (Norway) (“Smerud”), the Company is liable for development costs incurred by Smerud in the approximate amount of $ 1,264
which has been accrued as of December 31, 2021, as payable to Smerud. However, effective March 28, 2022, the Company terminated
its LiPlasome rights through the following agreements:
21
A Letter Agreement between
Chosa Oncology Ltd. (England), Chosa ApS (Denmark) (collectively “Chosa”), Smerud, and Allarity Therapeutics, Inc. (US) which
references the following agreements:
a. The 2022 Amended and Restated License Agreement between LiPlasome Pharma Aps (Denmark) (“LiPlasome”), Chosa, and the Company’s subsidiary Allarity Therapeutics ApS, which amended the original February 15, 2016 LiPlasome License Agreement (as amended January 27, 2021), whereby Chosa replaced the Company as licensee of LiPlasome in exchange for Smerud’s cancellation of the Company’s $ 1,309 liability to Smerud and the Company’s agreement to pay $ 338 to LiPlasome. Consequently, as at September 30, 2022, the Company recognized other income on the sale of IP of $ 971 and recorded a balance due to LiPlasome of $ 338 in accrued liabilities, which was paid on April 1, 2022.
b.
The LiPlacis Support Agreement
between Allarity Therapeutics Europe, Smerud, Chosa and LiPlasome. Terms of the Support Agreement provide that each of Smerud and
the Company agreed that the 2022 Sublicense Agreement is terminated in its entirety.
(e) Oncoheroes
Effective January 2, 2022,
the Company entered into an Exclusive License Agreement with Oncoheroes Biosciences Inc. (the “Oncoheroes Agreement”) to
grant Oncoheroes an exclusive royalty-bearing global license to both dovitinib and stenoparib in pediatric cancers. Oncoheroes will take
responsibility for pediatric cancer clinical development activities for both clinical-stage therapeutics. Allarity will support Oncoheroes’
pediatric clinical trials by providing clinical-grade drug inventory at cost and by facilitating DRP® companion diagnostic screening
of pediatric patients for each drug. Under the licenses, Oncoheroes will receive commercialization rights for pediatric cancers, subject
to the Company’s first buy-back option for each program, and the Company will receive an upfront license fee and regulatory milestones
for each program, specifically one for dovitinib and one for stenoparib, as follows:
i. a one-time upfront payment of $250 and $100 for stenoparib and dovitinib respectively, within 5 business days after January 2, 2022 ($350 received as of January 11, 2022, and recorded in other income as proceeds on sale of IP); and
ii.
two milestone payments
of $1,000 each due and payable upon receipt of regulatory approval of a product in the United States, and of a product in Europe,
respectively.
Pursuant to the Oncoheroes
Agreement Allarity is also entitled to tiered royalties on aggregate net product sales (“Sales”) of between 7% and 12% on
net sales of products as follows: 7% on Sales less than $100 million; 10% on Sales of greater than $100 million and less than $200 million;
and 12% on Sales greater than $200 million.
(f) Lantern Pharma, Inc. – Irofulven Agreement
On July 23, 2021, we entered
into an Asset Purchase Agreement with Lantern Pharma, Inc. relating to our inventory of Irofulven active pharmaceutical ingredients,
our clinical research data relating to Irofulven developed by us during the drug development program under the May 2015 Drug License
and Development Agreement for Irofulven and terminated our obligation to further advance the development of Irofulven under the May 2015
agreement. Under the Asset Purchase Agreement, Lantern Pharma agreed to pay us $ 1 million on the closing of the transaction, and additional
amounts:
(i)
when the inventory of Irofulven
API is recertified with a longer shelf life;
(ii)
upon the initiation of
treatment of the first patient in an investigator-led “compassionate use” ERCC2/3 mutation subgroup study using Irofulven
in certain agreed upon investigators;
(iii)
upon the initiation of
treatment of the first patient within twenty-four months after the closing of the transaction in any human clinical trial of Irofulven
initiated by Lantern Pharma; and
(iv)
upon the initiation of
treatment of the second patient within an agreed upon time period after the closing of the transaction in any human clinical trial
of Irofulven initiated by Lantern Pharma.
Effective March 18, 2022,
pursuant to clause (i) the inventory was recertified with a longer shelf life and as of March 31, 2022, we received $ 459 which has
been recorded in other income as proceeds on sale of IP.
22
(g) SEC Request
In January 2023, we received
a request to produce documents from the SEC that stated that the staff of the SEC is conducting an investigation known as “In the
Matter of Allarity Therapeutics, Inc.” to determine if violations of the federal securities laws have occurred. The documents requested
appear to focus on submissions, communications, and meetings with the FDA regarding our NDA for Dovitinib or Dovitinib-DRP. The SEC letter
also stated that investigation is a fact-finding inquiry and does not mean that that the SEC has concluded that we or anyone else has
violated the laws. As a result of the disclosure of the SEC request, The Nasdaq Stock Market LLC (“Nasdaq”) staff has also
requested us to provide them with the information requested by the SEC in which we are complying.
(h) Nasdaq Notification
As previously disclosed
on Form 8-K filed with the SEC on October 14, 2022, we received a letter from Nasdaq Listing Qualifications on October 12, 2022 notifying
us that the Company’s stockholders’ equity as reported in its Quarterly Report on Form 10-Q for the period ended June 30,
2022 (the “Form 10-Q”), did not satisfy the continued listing requirement under Nasdaq Listing Rule 5450(b)(1)(A) for The
Nasdaq Global Market, which requires that a listed company’s stockholders’ equity be at least $ 10.0 million. As reported
on the Form 10-Q, the Company’s stockholders’ equity as of June 30, 2022, was approximately $ 8.0 million. Pursuant to the
letter, we were required to submit a plan to regain compliance with Nasdaq Listing Rule 5450(b)(1)(A) by November 26, 2022. After discussions
with the Nasdaq Listing Qualifications staff, on December 12, 2022, we filed a plan to regain and demonstrate long-term Nasdaq Listing
Qualifications compliance including seeking to phase-down to The Nasdaq Capital Market. On December 21, 2022, we received notification
from the Nasdaq Listing Qualifications staff that they have granted the Company’s request for an extension until April 10, 2023,
to comply with this requirement.
On April 11, 2023, we received
notification from the Nasdaq Listing Qualifications staff that it has determined that the Company did not meet the terms of the extension.
Specifically, the Company did not complete its proposed transactions and was unable to file a Form 8-K by the April 10, 2023, deadline,
evidencing compliance with Nasdaq Listing Rule 5450(b)(1)(A). As a result, the Company’s securities will be delisted from The Nasdaq
Global Market. In that regard, unless the Company requests an appeal of such determination by April 18, 2023, trading of the Company’s
Common Stock will be suspended at the opening of business on April 20, 2023, and a Form 25-NSE will be filed with the SEC which will
remove the Company’s common stock from listing and registration on The Nasdaq Stock Market. The Company has filed its appeal with
Nasdaq and has received a hearing date of May 18, 2023.
18. Subsequent Events
For its financial statements
as of March 31, 2023, and for the three months then ended, the Company evaluated subsequent events through the date on which those financial
statements were issued. All subsequent events not disclosed elsewhere in this Form 10-Q are disclosed below.
(a) Public Offering
On April 19, 2023, the Company
agreed to sell in a public offering an aggregate of 2,869,330 shares of Common Stock of the Company (the “Shares”), pre-funded
warrants to purchase up to 7,130,670 shares of Common Stock (the “Pre-Funded Warrants”), and common warrants to purchase up
to 10,000,000 shares of Common Stock (the “Common Warrants” together with the Shares, the Pre-Funded Warrants and Common Stock
issuable upon exercise of the Common Warrants and the Pre-Funded Warrant, collectively, the “Securities”), at an effective
combined purchase price of $ 0.75 per share and related Common Warrant (the “Purchase Price”), for aggregate gross proceeds
of approximately $ 7.5 million, before deducting placement agents fees and offering expenses payable by the Company (the “Offering”).
The Securities were sold pursuant to a Securities Purchase Agreement (the “Purchase Agreement”) with each purchaser identified
on the signature pages thereto (each, a “Purchaser”) or pursuant a prospectus which was part of an effective registration
statement on Form S-1 filed with the SEC. The purchase price of each Pre-Funded Warrant and Common Warrant is equal to the Purchase Price
less the $ 0.001 per share exercise price of each Pre-Funded Warrant. The closing of the Offering occurred on April 21, 2023 (the “Offering
Closing”). The Pre-Funded Warrants and Common Warrants are immediately separable and were issued separately in the Offering. Each
Pre-Funded Warrant is exercisable for one share of Common Stock.
Subject to certain ownership
limitations, the Pre-Funded Warrants and the Common Warrants (the “Warrants”) are exercisable immediately from the date of
issuance. The Pre-Funded Warrants have a nominal exercise price of $ 0.001 per share, which was pre-funded to the Company on or prior
to the Initial Exercise Date (as defined in the Pre-Funded Warrants) and, consequently, no additional consideration (other than the nominal
exercise price of $ 0.001 per share) will be required to be paid by the holder to any person to effect any exercise of the Pre-Funded
Warrants, and will expire when exercised in full, subject to certain adjustments contained therein. The Common Warrants have an exercise
price of $ 0.85 per share and expire on the 5 year anniversary of the date of issuance. The exercise price of the Warrants is subject
to certain adjustments, including stock dividends, stock splits, combinations and reclassifications of the Company’s common stock.
As of the date of this filing, all of the Pre-Funded Warrants have been exercised.
23
In the event of a fundamental
transaction, as described in the Warrants, each of the holders of the Warrants will have the right to exercise its Warrant and receive
the same amount and kind of securities, cash or property as such holder would have been entitled to receive upon the occurrence of such
fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of shares of the Company’s
common stock issuable upon the exercise of its Warrant. Additionally, in the event of a fundamental transaction within the Company’s
control, as described in the Warrants, each holder of the Warrants will have the right to require the Company to repurchase the unexercised
portion of its Warrant at its fair value using a variant of the Black Scholes option pricing formula. In the event of a fundamental transaction
that is not within the Company’s control, each holder of the Warrants will have the right to require the Company or a successor
entity to redeem the unexercised portion of its Warrant for the same consideration paid to the holders of the Company’s common
stock in the fundamental transaction at the unexercised Warrant’s fair value using a variant of the Black Scholes option pricing
formula. The Purchase Agreement includes customary representations, warranties and covenants by the Company and the Purchasers, and the
Company has agreed to provide the Purchasers with customary indemnification under the Purchase Agreement.
Concurrently with the Purchase
Agreement, the Company entered into a Placement Agency Agreement with A.G.P./Alliance Global Partners (“AGP”). AGP acted
as the exclusive Placement Agent in connection with the Offering. As compensation, the Company agreed to pay AGP a cash fee equal to
7.0 % of the aggregate gross proceeds of the Offering and up to $ 150 in aggregate for all expenses of AGP, including AGP’s legal
fees. The Company also agreed to provide the Placement Agent with customary indemnification under the Purchase Agreement.
(b) 3i LP Transactions
From April 1, 2023, through
May 11, 2023, the Company issued 7,954,880 shares of common stock valued at $ 1,334 upon the conversion of 7,520 shares of Series A Preferred
stock
On April 19, 2023, 3i,
the sole former holder of our Series C Preferred Stock and outstanding secured promissory notes, and sole holder of our Series A Preferred
Stock and Exchange Warrant (as defined below), provided the Company with a loan for $ 350 , which is evidenced by a Secured Promissory
Note dated April 19, 2023 (the “April Note”), which requires a mandatory conversion of the principal into 486 shares
of Series A Preferred Stock (the “Note Conversion Shares” and together with the April Note, the “Note Securities”)
subject to and upon the Offering Closing. Upon the Offering Closing, the Note Conversion Shares were issued to 3i and the April Note
was cancelled.
On April 20, 2023, the Company
entered into a certain Modification and Exchange Agreement (the “Exchange Agreement”) with 3i pursuant to which the parties
agreed to, among other things, subject to the Offering Closing, (i) amend the Certificate of Designations for the Series A Convertible
Preferred Stock (the “Amended COD”), which among other things, eliminates the Series A Preferred Stock redemption right and
dividend (except for certain exceptions as specified in the Amended COD), and provides for the conversion of Series A Preferred Stock
into Common Stock at a conversion price of $0.75 which is equal to the price for a share of Common Stock sold in the Offering, (ii) exchange
50,000 shares of Series C Preferred Stock (the “Series C Shares”) beneficially owned by 3i for 4,027 shares of Series A Preferred
Stock (the “Exchange Shares”), (iii) exchange a warrant to purchase common stock issued on December 20, 2021 to 3i (the “Original
Warrant”) for a new warrant (the “Exchange Warrant”), which reflects an exercise price of $0.75 (the “New Exercise
Price”) and represents a right to acquire 12,603,385 shares of Common Stock (the “New Warrant Shares”). In addition
to the satisfaction or waiver of customary and additional closing conditions set forth in the Exchange Agreement, the transactions contemplated
by the Exchange Agreement were subject to (a) the occurrence of the closing of the Offering and (b) the filing of the Amended COD with
the Delaware Secretary of State. On April 21, 2023, the closing of the transactions contemplated by the Exchange Agreement occurred and
the Exchange Warrant and the Exchange Shares were issued to 3i, and the Original Warrant and the Series C Shares were cancelled.
In addition, the Company entered
into a Cancellation of Debt Agreement dated April 20, 2023, which became effective as of the Offering Closing. Upon the Offering Closing,
pursuant to the terms of the Cancellation of Debt Agreement, all of the Company’s outstanding indebtedness under the Notes (as defined
therein) and the Alternative Conversion Amount (as defined therein) due by the Company to 3i were paid in full. Accordingly, any and all
obligations in connection therewith were extinguished without any additional further action on the part of 3i upon payment of $ 3,348 in
cash from a portion of the proceeds from the Offering. In addition, pursuant to such agreement, 1,550 shares of Series A Preferred Stock
(the “Redemption Shares”) beneficially owned by 3i were redeemed in full for a purchase price of $ 1,652 , which redemption
price was paid in cash from the portion of the proceeds from the Offering. The Company also entered into the First Amendment to the
RRA (the “RRA Amendment”) dated April 20, 2023, which became effective upon the Offering Closing, to amend certain defined
terms under the RRA to include the Exchange Shares, the New Warrant Shares and the Note Conversion Shares.
24
In addition to the foregoing,
the Company and 3i are also parties to (i) a Securities Purchase Agreement dated May 20, 2021 (as amended), relating to the purchase
and sale of 20,000 shares of Series A Preferred Stock, and common stock purchase warrants, (ii) the RRA, (iii) a Securities Purchase
Agreement and Registration Rights Agreement, each dated February 28, 2023, relating to the purchase and sale of 50,000 shares of Series
C Preferred Stock, and (iv) a Secured Note Purchase Agreement dated November 22, 2022 (as amended) and related Security Agreement pursuant
to which the Company has issued certain secured promissory notes for an aggregate principal amount of approximately $ 3 million as of
April 19, 2023. 3i also participated in the Offering. See Note 9.
(c) Amended and Restated COD of Series A Convertible Preferred Stock
On
April 21, 2023, in connection with the transactions contemplated under the Exchange Agreement, the Company filed an Amended and Restated
Certificate of Designations of Series A Convertible Preferred Stock of the Company (the “Amended and Restated Series A COD”) with
the Delaware Secretary of State. The Amended and Restated Series A COD eliminates the Series A Preferred Stock redemption right
and dividend (except for certain exceptions as specified therein), and provide for the conversion of Series A Preferred Stock into Common
Stock at a conversion price equal to the price for a share of Common Stock sold in the Offering.
(d) Pro-forma Balance Sheet (unaudited)
The following pro forma
unaudited condensed consolidated balance sheet is provided to illustrate the impact of all subsequent event transactions described in
the foregoing subsequent events disclosure, as if they had occurred at March 31, 2023.
As of March 31,
2023
(UNAUDITED)
(In thousands, except share data)
Actual
Pro Forma
ASSETS
Cash
$ 295
$ 2,810
Total other current assets
2,671
2,671
Total non-current assets
9,736
9,736
Total assets
$ 12,702
$ 15,217
LIABILITIES AND STOCKHOLDER’S EQUITY (DEFICIT)
Total current liabilities
$ 11,588
$ 8,523
Total non-current liabilities
1,453
1,453
Total liabilities
13,041
9,976
Total Redeemable preferred stock
2,763
—
Shareholders equity (deficit)
Total Redeemable preferred stock
—
2,202
Additional paid-in capital
83,437
89,578
Accumulated other comprehensive loss
( 637 )
( 637 )
Accumulated deficit
( 85,902 )
( 85,902 )
Total Stockholders’ (deficit) equity
( 3,102 )
5,241
Total liabilities and stockholders’ equity (deficit)
$ 12,702
$ 15,217
25
Item 2. Management’s Discussion and
Analysis of Financial Condition and Results of Operations.
You should read the following
discussion and analysis of our financial condition and plan of operations together with our condensed consolidated financial statements
and the related notes appearing elsewhere in this Quarterly Report. In addition to historical information, this discussion and analysis
contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from
the plans, intentions, expectations and other forward-looking statements included in the discussion below. Factors that could cause or
contribute to such differences include, but are not limited to, those identified below, and those factors discussed in the section titled
“Risk Factors” of our Annual Report on Form 10-K, filed with the SEC on March 13, 2023.
Overview
We are a biopharmaceutical
company focused on discovering and developing highly targeted anti-cancer drug candidates. Through the use of its Drug Response Predictor
(DRP ® ) platform, the Company identifies the value in drug assets that have otherwise been discontinued by identifying
patient populations where these drugs are active. The Company’s three lead drug candidates are: the tyrosine kinase inhibitor (TKI)
dovitinib, the poly-ADP-ribose polymerase (PARP) inhibitor stenoparib, and the microtubule inhibitor agent IXEMPRA.
Recent Developments
Redemption of Series B Preferred Stock
Upon conclusion of the 2023
Annual Meeting of Stockholders, all of the 190,786 shares of Series B Preferred Stock outstanding were automatically redeemed, with the
holders of the Series B Preferred Stock only having a right to receive the purchase price for the redemption, which was $0.01 per share
of Series B Preferred Stock.
Amendment to Certain Employment Contracts
On January 12, 2023, we entered
into new employment agreements with James G. Cullem, our chief executive officer, and Joan Brown, our chief financial officer, regarding
salary, bonuses, stock options and change of control provisions.
SEC Request
In January 2023, we received
a request to produce documents from the SEC that stated that the staff of the SEC is conducting an investigation known as “In the
Matter of Allarity Therapeutics, Inc.” to determine if violations of the federal securities laws have occurred. The documents requested
appear to focus on submissions, communications and meetings with the FDA regarding our NDA for Dovitinib or Dovitinib-DRP. The SEC letter
also stated that investigation is a fact-finding inquiry and does not mean that that the SEC has concluded that we or anyone else has
violated the laws. As a result of the disclosure of the SEC request, The Nasdaq Stock Market LLC (“Nasdaq”) staff has also
requested us to provide them with the information requested by the SEC in which we are complying.
Change in Board of Directors; Nasdaq Non-Compliance
On January 19, 2023, three
members of the board indicated that they resigned, or will resign with an effective date, from the board. Currently, the board consists
of four members. On February 8, 2023, we received a notice from Nasdaq notifying us that we no longer comply with Nasdaq’s independent
director and audit committee requirements. We have a cure period to regain compliance as follows: (i) until the earlier our next annual
shareholders’ meeting or February 4, 2024; or (ii) if our next annual shareholders’ meeting is held before August 3, 2023,
then we must evidence compliance no later than August 3, 2023.
Modification to Conversion Price of Series
A Preferred Stock
On January 23, 2023, we and
3i, LP amended the letter agreement entered into on December 8, 2022, to provide that the modification of the term Series A Preferred
Stock Conversion Price (“Series A Preferred Stock Conversion Price”) to mean the lower of: (i) the Closing Sale Price (as
defined in the Certificate of Designations of Series A Preferred Stock (“Series A Certificate of Designations”)) on the trading
date immediately preceding the Conversion Date (as defined in the Series A Certificate of Designations and (ii) the average Closing Sale
Price of the common stock for the five trading days immediately preceding the Conversion Date, for the Trading Days (as defined in the
Series A Certificate of Designations) will be in effect until terminated by us and 3i, LP.
26
Establishment and sale of Series C Convertible
Redeemable Preferred Stock
On February 24, 2023, we
filed a Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Redeemable Preferred Stock (“Series
C Preferred Stock Certificate of Designations”) with the Delaware Secretary of State designating 50,000 shares of our authorized
and unissued preferred stock as Series C Convertible Redeemable Preferred Stock (“Series C Preferred Stock”) with a stated
value of $27.00 per share. On February 28, 2023, we filed a Certificate of Amendment to the Series C Preferred Stock Certificate of Designations
with the Delaware Secretary of State to clarify the terms of conversion price and floor price based on definitions provided in the original
Series C Preferred Stock Certificate of Designations (the original and amended Series C Preferred Stock Certificate of Designations collectively
“the Series C Certificate of Designations”). Each share of Series C Preferred Stock has 620 votes and is subject to certain
redemption rights and voting limitations. On February 28, 2023, we entered into a securities purchase agreement with 3i, LP for the purchase
and sale of 50,000 shares of Series C Preferred Stock at a purchase price of $24.00 per share, for a subscription receivable in the aggregate
amount equal to the total purchase price of $1.2 million. The 50,000 shares of Series C Preferred Stock are convertible into shares of
our common stock, subject to the terms of the Series C Certificate of Designations. The conversion price for the Series C Preferred Stock
is initially equal the lower of: (i) $6.37, which is the official closing price of the common stock on the Nasdaq Global Market (as reflected
on Nasdaq.com) on the Trading Day (as defined in the Series C Certificate of Designations) immediately preceding the Original Issuance
Date (as defined in the Series C Certificate of Designations); and (ii) the lower of: (x) the official closing price of the common stock
on the Nasdaq Global Market (as reflected on Nasdaq.com) on the Trading Day immediately preceding the Conversion Date or such other date
of determination; and (y) the average of the official closing prices of the common stock on the Nasdaq Global Market (as reflected on
Nasdaq.com) for the five Trading Days immediately preceding the Conversion Date (as defined in the Series C Certificate of Designations)
or such other date of determination, subject to adjustment (the “Series C Preferred Stock Conversion Price”). In no event
will the Series C Preferred Stock Conversion Price be less than $1.295 (the “Series C Preferred Stock Floor Price”). As discussed
below, on April 21, 2023, all of the outstanding shares of Series C Preferred Stock were exchanged for 4,027 shares of our Series A Preferred
Stock pursuant to the terms of a certain Modification and Exchange Agreement.
Annual Stockholder Meeting
On February 3, 2023, we held
our annual meeting of stockholders (the “Annual Meeting”). Nine proposals were submitted to our stockholders for a vote at
the Annual Meeting including a proposal to increase the number of authorized shares and a proposal to effect a reverse stock split. The
proposals to increase the number of authorized shares and proposal to effect a reverse stock split did not receive the requisite votes.
Special Meeting of Stockholders; Share Consolidation
and Share Increase
On March 20, 2023, we held
a Special Meeting of Stockholders (the “Special Meeting”) for our stockholders of record of our outstanding shares of Common
Stock and Series C Preferred Stock. At the Special Meeting, the stockholders of Common Stock and Series C Preferred Stock approved: (1)
an amendment to our Certificate of Incorporation, as amended (“Certificate of Incorporation”), to increase the number of
authorized shares from 30,500,000 to 750,500,000, and to increase the number of our common stock from 30,000,000 to 750,000,000 (the
“Share Increase Proposal”); and (2) an amendment to our Certificate of Incorporation, to, at the discretion of the board,
effect a reverse stock split with respect to our issued and outstanding common stock at a ratio between 1-for-20 and 1-for-35 (the “Reverse
Stock Split Proposal”). Upon stockholder approval, the Board of Directors determined a ratio of 1-for-35 for the reverse stock
split. In addition, the Company filed a Second Certificate of Amendment of the Certificate of Incorporation to effect the share increase
approved by the stockholders.
We effected a 1-for-35 share consolidation of
our common stock on March 24, 2023 (“Share Consolidation”). No fractional shares were issued in connection with the Share
Consolidation. If, as a result of the Share Consolidation, a stockholder would otherwise have been entitled to a fractional share, each
fractional share was rounded up to the next whole number. The Share Consolidation resulted in a reduction of our outstanding shares of
common stock from 34,294,582 to 979,846. As a result of the Second Certificate of Amendment of our Certificate of Incorporation as discussed
above, the number of our authorized shares is 750,500,000 which consist of 750,000,000 authorized shares of Common Stock and 500,000
authorized shares of preferred stock. The par value of our authorized stock remained unchanged at $0.0001.
Notice of Breach From Novartis Pharma AG
Pursuant to a license agreement
with Novartis dated April 6, 2018, through our wholly-owned subsidiary Allarity Therapeutics Europe ApS, we have the right to use dovitinib
used in combination with stenoparib to address the second-line or later treatment of metastatic ovarian cancer. Under the terms of the
license agreement, we are required to make certain milestone payments, including a payment of $1,500 which was due on April 1, 2023.
We did not make that milestone payment, and on April 4, 2023, Novartis sent a notice of breach under the license agreement to Allarity
Therapeutics Europe ApS stating that it has 30 days from April 4, 2023, to cure. See “RISK FACTORS -Risks Related to Our Business
-We are in default under our license agreement with Novartis.”
27
Modification to Bridge Loan with 3i, LP
On April 10, 2023, we entered
into a first amendment to the Secured Note Purchase Agreement with 3i, LP. The Secured Note Purchase Agreement provided for the offer
and sale of three (3) secured promissory notes for an aggregate principal amount of $2,667, which were issued on November 28, 2022 and
December 30, 2022, and represents the aggregate principal amount outstanding under the notes issued under the Secured Note Purchase Agreement
as of April 10, 2023 (the “Prior Notes”). The Secured Note Purchase Agreement was amended to provide for the offer and sale
of additional notes from time to time, at the sole discretion of 3i, LP, which note purchase(s) is evidenced by a form of note which
was agreed upon by the Company and 3i, LP (the “2023 Note” and together with the Prior Notes (the “Notes”) and
is substantially in the same form as the secured promissory notes issued in connection with the Secured Note Purchase Agreement dated
November 22, 2022, with the exception that an event of default would occur under the 2023 Notes in the event the Company has been delisted
from The Nasdaq Stock Exchange LLC. On April 10, 2023, in connection with the first amendment, the Company and 3i, LP entered into an
amendment to the security agreement by and between 3i, LP and the Company, dated November 23, 2022 (as amended, the “Security Agreement”),
to cover the additional notes issued under the Secured Note Purchase Agreement. On April 11, 2023, 3i, LP purchased an additional note
for an aggregate amount of $350, which purchase price was paid in cash. As discussed below, pursuant to the Cancellation Debt Agreement,
all of the indebtedness evidenced by the Notes was paid in full and cancelled on April 21, 2023.
Nasdaq Notification
As previously disclosed on
Form 8-K filed with the SEC on October 14, 2022, we received a letter from Nasdaq Listing Qualifications on October 12, 2022 notifying
us that the Company’s stockholders’ equity as reported in its Quarterly Report on Form 10-Q for the period ended June 30,
2022 (the “Form 10-Q”), did not satisfy the continued listing requirement under Nasdaq Listing Rule 5450(b)(1)(A) for The
Nasdaq Global Market, which requires that a listed company’s stockholders’ equity be at least $10.0 million. As reported
on the Form 10-Q, the Company’s stockholders’ equity as of June 30, 2022 was approximately $8.0 million. Pursuant to the
letter, we were required to submit a plan to regain compliance with Nasdaq Listing Rule 5450(b)(1)(A) by November 26, 2022. After discussions
with the Nasdaq Listing Qualifications staff, on December 12, 2022, we filed a plan to regain and demonstrate long-term Nasdaq Listing
Qualifications compliance including seeking to phase-down to The Nasdaq Capital Market. On December 21, 2022, we received notification
from the Nasdaq Listing Qualifications staff that they have granted the Company’s request for an extension until April 10, 2023,
to comply with this requirement.
On April 11, 2023, we received
notification from the Nasdaq Listing Qualifications staff that it has determined that the Company did not meet the terms of the extension.
Specifically, the Company did not complete its proposed transactions and was unable to file a Form 8-K by the April 10, 2023 deadline,
evidencing compliance with Nasdaq Listing Rule 5450(b)(1)(A). As a result, the Company’s securities will be delisted from The Nasdaq
Global Market. In that regard, unless the Company requests an appeal of such determination by April 18, 2023, trading of the Company’s
Common Stock will be suspended at the opening of business on April 20, 2023, and a Form 25-NSE will be filed with the SEC which will
remove the Company’s common stock from listing and registration on The Nasdaq Stock Market. The Company has filed its appeal with
Nasdaq and has received a hearing date of May 18, 2023.
Public Offering.
On April 19, 2023, we agreed to
sell in a public offering an aggregate of 2,869,330 shares of Common Stock of the Company (the “Shares”), pre-funded warrants
to purchase up to 7,130,670 shares of Common Stock (the “Pre-Funded Warrants”), and common warrants to purchase up to 10,000,000
shares of Common Stock (the “Common Warrants” together with the Shares, the Pre-Funded Warrants and Common Stock issuable
upon exercise of the Common Warrants and the Pre-Funded Warrant, collectively, the “Securities”), at an effective combined
purchase price of $0.75 per share and related Common Warrant (the “Purchase Price”), for aggregate gross proceeds of approximately
$7.5 million, before deducting placement agents fees and offering expenses payable by the Company (the “Offering”). The Securities
were sold pursuant to a Securities Purchase Agreement (the “Purchase Agreement”) with each purchaser identified on the signature
pages thereto (each, a “Purchaser”) or pursuant a prospectus which was part of an effective registration statement on Form
S-1 filed with the SEC. The purchase price of each Pre-Funded Warrant and Common Warrant is equal to the Purchase Price less the $0.001
per share exercise price of each Pre-Funded Warrant. The closing of the Offering occurred on April 21, 2023 (the “Offering Closing”).
28
The Pre-Funded Warrants and
Common Warrants are immediately separable and were issued separately in the Offering. Each Pre-Funded Warrant is exercisable for one
share of Common Stock. Subject to certain ownership limitations, the Pre-Funded Warrants and the Common Warrants (the “Warrants”)
are exercisable immediately from the date of issuance. The Pre-Funded Warrants have a nominal exercise price of $0.001 per share, which
was pre-funded to the Company on or prior to the Initial Exercise Date (as defined in the Pre-Funded Warrants) and, consequently, no
additional consideration (other than the nominal exercise price of $0.001 per share) will be required to be paid by the holder to any
person to effect any exercise of the Pre-Funded Warrants, and will expire when exercised in full, subject to certain adjustments contained
therein. The Common Warrants have an exercise price of $0.85 per share and expire on the five (5) year anniversary of the date of issuance.
The exercise price of the Warrants is subject to certain adjustments, including stock dividends, stock splits, combinations and reclassifications
of the Company’s common stock. In the event of a fundamental transaction, as described in the Warrants, each of the holders of
the Warrants will have the right to exercise its Warrant and receive the same amount and kind of securities, cash or property as such
holder would have been entitled to receive upon the occurrence of such fundamental transaction if such holder had been, immediately prior
to such fundamental transaction, the holder of shares of the Company’s common stock issuable upon the exercise of its Warrant.
Additionally, in the event of a fundamental transaction within the Company’s control, as described in the Warrants, each holder
of the Warrants will have the right to require the Company to repurchase the unexercised portion of its Warrant at its fair value using
a variant of the Black Scholes option pricing formula. In the event of a fundamental transaction that is not within the Company’s
control, each holder of the Warrants will have the right to require the Company or a successor entity to redeem the unexercised portion
of its Warrant for the same consideration paid to the holders of the Company’s common stock in the fundamental transaction at the
unexercised Warrant’s fair value using a variant of the Black Scholes option pricing formula. The Purchase Agreement includes customary
representations, warranties and covenants by the Company and the Purchasers, and the Company has agreed to provide the Purchasers with
customary indemnification under the Purchase Agreement.
Concurrently with the Purchase
Agreement, the Company entered into a Placement Agency Agreement (the “Placement Agency Agreement”) with A.G.P./Alliance
Global Partners (“AGP”). AGP acted as the exclusive Placement Agent in connection with the Offering. As compensation, the
Company agreed to pay AGP a cash fee equal to 7.0% of the aggregate gross proceeds of the Offering and up to $150 in aggregate for all
expenses of AGP, including AGP’s legal fees. The Company also agreed to provide the Placement Agent with customary indemnification
under the Purchase Agreement
Additional Transactions with 3i, L.P.
On April 19, 2023, 3i, LP,
provided the Company with a loan for $350, which was evidenced by a Secured Promissory Note dated April 19, 2023 (the “April Note”),
which required a mandatory conversion of the principal into 486 shares of Series A Preferred Stock, subject to and upon the Offering Closing.
Upon the Offering Closing, on April 21, 2023 the Note Conversion Shares were issued to 3i, LP and the April Note was cancelled.
On April 20, 2023, the Company
entered into a certain Modification and Exchange Agreement (the “Exchange Agreement”) with 3i, LP pursuant to which the parties
agreed to, among other things, subject to the Offering Closing, (i) amend the Certificate of Designations for the Series A Convertible
Preferred Stock (the “Amended COD”), which among other things, eliminates the Series A Preferred Stock redemption right and
dividend (except for certain exceptions as specified in the Amended COD), and provides for the conversion of Series A Preferred Stock
into Common Stock at a conversion price of $0.75 which is equal to the price for a share of Common Stock sold in the Offering, (ii) exchange
50,000 shares of Series C Preferred Stock (the “Series C Shares”) beneficially owned by 3i, LP for 4,027 shares of Series
A Preferred Stock (the “Exchange Shares”), (iii) exchange a warrant to purchase common stock issued on December 20, 2021 to
3i, LP (the “Original Warrant”) for a new warrant (the “Exchange Warrant”), which reflects an exercise price of
$0.75 (the “New Exercise Price”) and represents a right to acquire 12,603,385 shares of Common Stock (the “New Warrant
Shares”). In addition to the satisfaction or waiver of customary and additional closing conditions set forth in the Exchange Agreement,
the transactions contemplated by the Exchange Agreement were subject to (a) the occurrence of the closing of the Offering and (b) the
filing of the Amended COD with the Delaware Secretary of State. On April 21, 2023, the closing of the transactions contemplated by the
Exchange Agreement occurred and the Exchange Warrant and the Exchange Shares were issued to 3i, LP, and the Original Warrant and the Series
C Shares were cancelled. In addition, on April 21, 2023, the Amended COD was filed with the Delaware Secretary of State.
In addition, the Company entered
into a Cancellation of Debt Agreement dated April 20, 2023 (the “Cancellation of Debt Agreement”), which became effective
as of the Offering Closing. Upon the Offering Closing, pursuant to the terms of the Cancellation of Debt Agreement, all of the Company’s
outstanding indebtedness under the Notes and the Alternative Conversion Amount (as defined therein) due by the Company to 3i, LP were
paid in full. Accordingly, any and all obligations in connection therewith were extinguished without any additional further action on
the part of 3i, LP upon payment of $3,348 in cash from a portion of the proceeds from the Offering. In addition, pursuant to such agreement,
1,550 shares of Series A Preferred Stock (the “Redemption Shares”) beneficially owned by 3i, LP were redeemed in full for
a purchase price of $1,652, which redemption price was paid in cash from the portion of the proceeds from the Offering. The Company also
entered into the First Amendment to the Registration Rights Agreement dated May 20, 2023 (the “RRA”), which became effective
upon the Offering Closing, to amend certain defined terms under the RRA to include the Exchange Shares, the New Warrant Shares and the
Note Conversion Shares.
29
Series A Preferred Stock
Subsequent to March 31, 2023,
3i, LP exercised 7,520 shares of Series A Preferred Stock pursuant to which the Company issued 7,954,880 shares of Common Stock. As of
May 11, 2023, there were 5,191 shares of Series A Preferred Stock outstanding which includes the 4,207 Exchange Shares but excludes the
1,550 Redemption Shares.
Risks and Uncertainties
The Company is subject to
risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical
trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully
commercialize and gain market acceptance of its product candidates, dependence on key personnel and collaboration partners, protection
of proprietary technology, compliance with government regulations, development by competitors of technological innovations, and the ability
to secure additional capital to fund operations. Product candidates currently under development will require significant additional research
and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. Even if the Company’s
research and development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product
sales.
Financial Operations Overview
Since our inception in September
of 2004, we have focused substantially all our resources on conducting research and development activities, including drug discovery
and preclinical studies, establishing, and maintaining our intellectual property portfolio, the manufacturing of clinical and research
material, hiring personnel, raising capital and providing general and administrative support for these operations. In recent years, we
have recorded very limited revenue from collaboration activities, or any other sources. We have funded our operations to date primarily
from convertible notes and the issuance and sale of our ordinary shares.
We have incurred net losses
in each year since inception. Our net losses were $3.4 million and $3.1 million for the three months ended March 31, 2023 and 2022, respectively.
As of March 31, 2023, we had an accumulated deficit of $85.9 million and cash of $295,000. Substantially all our net losses have resulted
from costs incurred in connection with our research and development programs and from general and administrative costs associated with
our operations. We expect to continue to incur significant expenses and increasing operating losses over at least the next several years.
We expect our expenses will increase substantially in connection with our ongoing activities, as we:
●
advance drug candidates
through clinical trials;
●
pursue regulatory approval
of drug candidates;
●
operate as a public company;
●
continue our preclinical
programs and clinical development efforts;
●
continue research activities
for the discovery of new drug candidates; and
●
manufacture supplies for
our preclinical studies and clinical trials.
Components of Operating Expenses
Research and Development Expenses
Research and development expenses include:
●
expenses incurred under
agreements with third-party contract organizations, and consultants;
●
costs related to production
of drug substance, including fees paid to contract manufacturers;
●
laboratory and vendor expenses
related to the execution of preclinical trials; and
●
employee-related expenses,
which include salaries, benefits and stock-based compensation.
30
We expense all research and
development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation
of the progress to completion of specific tasks and estimates of services performed using information and data provided to us by our
vendors and third-party service providers. Non-refundable advance payments for goods or services to be received in future periods for
use in research and development activities are deferred and accounted for as prepaid expenses. The prepayments are then expensed as the
related goods are delivered and as services are performed.
To date, most of these expenses
have been incurred to advance our lead drug candidates, dovitinib, stenoparib, and IXEMPRA ® .
We expect our research and
development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities
related to developing our drug candidates, as our drug candidates advance into later stages of development, and as we continue to conduct
clinical trials. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming,
and the successful development of our drug candidates is highly uncertain. As a result, we are unable to determine the duration and completion
costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale
of any of our drug candidates.
General and Administrative Expenses
General and administrative
expenses consist primarily of personnel-related costs, facilities costs, depreciation and amortization expenses and professional services
expenses, including legal, human resources, audit, and accounting services. Personnel-related costs consist of salaries, benefits, and
stock-based compensation. Facilities costs consist of rent and maintenance of facilities. We expect our general and administrative expenses
to increase for the foreseeable future due to anticipated increases in headcount to advance our drug candidates and as a result of operating
as a public company, including expenses related to compliance with the rules and regulations of the SEC, Nasdaq Stock Market, additional
insurance expenses, investor relations activities and other administrative and professional services.
Results of Operations for the Three Months Ended
March 31, 2023 and 2022 (unaudited) (in thousands, except where otherwise noted)
The following table summarizes
our results of operations for the three months ended March 31, 2023 and 2022:
For the Three Months Ended
March 31,
Increase/
2023
2022
(Decrease)
(In thousands)
Operating expenses:
Research and development
$ 1,427
$ 1,289
$ 138
Impairment of intangible assets
—
14,007
(14,007 )
General and administrative
2,232
3,013
(781 )
Total operating expenses
3,659
18,309
(14,650 )
Loss from operations:
$ (3,659 )
$ (18,309 )
$ (14,650 )
Research and Development Expenses
We currently do not track
our research and development costs by product candidate. A breakdown by nature of type of expense for the three months ended March 31,
2023 and 2022 is provided below.
For the three months ended
March
31,
Increase/
2023
2022
(Decrease)
(In thousands)
Research study expenses
$ 834
$ 505
$ 329
Tax credit
(480 )
(454 )
(26 )
Manufacturing & supplies
589
168
421
Contractors
289
377
(88 )
Patents
20
76
(56 )
Staffing
201
247
(46 )
Staffing, stock-based compensation
(39 )
362
(401 )
Amortization
10
20
(10 )
Other
3
(12 )
15
$ 1,427
$ 1,289
$ 138
31
For the three months ended
March 31, 2023, compared to March 31, 2022
The increase of $138 in research
and development expenses was primarily because manufacturing and supplies expenses increased by $421, research study expenses increased
by $329 and other expenses increased by $15, offset by a decrease in staffing costs of $46, decreased contractors costs of $88, decreased
patent costs of $56, decreased stock based compensation costs of $401, an increase in tax credits of $26, and decreased amortization
of $10. Research study expenses have increased because of increased site initiation costs, increased investigator sites, and increased
patient screening. Manufacturing and supplies expenses have increased because of increased drug manufacturing. Staffing and contractor
costs have decreased as a result of cost cutting measures, and stock-based compensation costs have decreased because of stock option
forfeitures of recently resigned directors.
Impairment of Intangible Assets
As a result of both the Company’s
February 15, 2022, receipt of a RTF from the U.S. Food and Drug Administration regarding the Company’s NDA for Dovitinib, and the
current depressed state of the Company’s stock price, the Company has performed an impairment assessment on its individual intangible
assets utilizing a discounted cash flow model and recognized an impairment charge of $14.0 million during the three months ended March
31, 2022.
General and Administrative Expenses
General and administrative
expenses decreased by $781 for the three months ended March 31, 2023, compared to March 31, 2022. The decrease was primarily due
to a $785 decrease in stock-based compensation, $147 decease in staffing costs, $69 decrease in other administrative costs, and a $51
decrease in listings expenses, offset by a $119 increase in audit and legal costs, $100 increase in financial consultants, $16 increase
in communications expenses and $12 increase in insurance and $24 increase on account of premises costs. Staffing costs have decreased
as a result of cost cutting measures, and stock-based compensation costs have decreased because of stock option forfeitures of recently
resigned directors.
Other Income (Expenses), Net
For the three months ended March 31, 2023,
compared to March 31, 2022
Other income (expense) of
$309 recognized in the three months ended March 31, 2023, consisted primarily of a $309 fair value adjustment to derivative and warrant
liabilities, foreign exchange gains of $95, and interest income of $4, offset by ($90) in interest expenses and ($9) in finance expenses.
Other income (expense) of
$14.0 million recognized in the three months ended March 31, 2022, consisted primarily of a $12.6 million fair value adjustment to derivative
and warrant liabilities and income of $1.8 million from the gain on sale of IP, offset by ($269) in foreign exchange losses, ($39) in
interest expenses, and ($36) loss on investment.
Changes in fair value of
our derivative liabilities and convertible debt are measured using level 3 inputs as described in our condensed consolidated financial
statements.
Liquidity, Capital Resources and Plan of Operations
Since our inception through
March 31, 2023, our operations have been financed primarily by the sale of convertible promissory notes and the sale and issuance of
our securities. As of March 31, 2023, we had $295 in cash, and an accumulated deficit of $85.9 million. We had a working capital deficit
of $8,620.
Our primary use of cash is
to fund operating expenses, which consist of research and development as well as regulatory expenses related to our lead drug candidate,
dovitinib, and clinical programs for stenoparib and IXEMPRA ® , and to a lesser extent, general and administrative expenses.
Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding
accounts payable and accrued expenses.
As of March 31, 2023, the
Company’s cash deposits of $295 were determined to be insufficient to fund its current operating plan and planned capital expenditures
for the next month. On April 21, 2023, the Company completed an equity financing and received net proceeds of approximately $1.9 million
which has been determined to be insufficient to fund the Company’s operations for longer than approximately three months. These
conditions give rise to substantial doubt over the Company’s ability to continue as a going concern.
32
Management’s plans
to mitigate the conditions or events that raise substantial doubt include additional funding through public equity, private equity, debt
financing, collaboration partnerships, or other sources. We currently plan on completing an additional public offering in the near future,
however there are no assurances that the Company will be successful in raising additional working capital, or if it is able to raise
additional working capital, it may be unable to do so on commercially favorable terms. The Company’s failure to raise capital or
enter into other such arrangements when needed would have a negative impact on its business, results of operations and financial condition
and its ability to continue its plan of operations.
We expect to incur substantial
expenses in the foreseeable future for the development and potential commercialization of our drug candidates and ongoing internal research
and development programs. At this time, we cannot reasonably estimate the nature, timing, or aggregate amount of costs for our development,
potential commercialization, and internal research and development programs. However, to complete our current and future preclinical
studies and clinical trials, and to complete the process of obtaining regulatory approval for our drug candidates, as well as to build
the sales, marketing, and distribution infrastructure that we believe will be necessary to commercialize our drug candidates, if approved,
we may require substantial additional funding in the future.
Contractual Obligations and Commitments
We enter into agreements
in the normal course of business with vendors for preclinical studies, clinical trials, and other service providers for operating purposes.
We have not included these payments in the table of contractual obligations above since these contracts are generally cancellable at
any time by us following a certain period after notice and therefore, we believe that our non-cancellable obligations under these agreements
are not material.
Cash Flows
The following table summarizes
our cash flows for the periods indicated:
For the three months ended
March 31,
2023
2022
(In thousands)
Net cash flows used in operating activities
$ (3,201 )
$ (5,755 )
Net cash flows provided by investing activities
—
809
Net cash flows provided by financing activities
1,158
—
Effect of foreign exchange rates on cash
309
(65 )
Net (decrease) in cash
(1,734 )
$ (5,011 )
Operating Activities
For
the three months ended March 31, 2023, net cash used in operating activities was approximately $3.2 million compared to approximately
$5.8 million for the three months ended March 31, 2022. The $2.6 million decrease in net cash used in operating activities was primarily
the result of an increased loss of $500 thousand and non-cash expenses of $100 thousand, offset by net cash provided by operating assets
and liabilities of $3.1 million.
Investing Activities
In the three months ended
March 31, 2023, there were no cash flows from investing activities. In the three months ended March 31, 2022, we received $809 thousand
from financing activities associated with the sale of IP.
Financing Activities
For
the three months ended March 31, 2023, net cash provided by financing activities was approximately $1.2 million compared to $0 for the
three months ended March 31, 2022. The increase in net cash provided by investing activities was primarily due to proceeds from the sale
of Series C Preferred Stock during the three months ended March 31, 2023.
33
Operating Capital and Capital Expenditure
Requirements
We believe that our existing cash
and cash equivalents of $759 as of May 11, 2023, and our anticipated expenditures and commitments for the next twelve months, will not
enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of this Report.
Our estimate as to how long we expect our cash to be able to continue to fund our operations is based on assumptions that may prove to
be wrong, and we could use our available capital resources sooner than we currently expect. Further, changing circumstances, some of which
may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek
additional funds sooner than planned.
Off-Balance Sheet Arrangements
The Company does not have
any off-balance sheet arrangements.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion
and analysis of financial condition and results of operations is based upon our unaudited condensed interim consolidated financial statements
for the three months ended March 31, 2023, and 2022, and our audited consolidated financial statements for the years ended December 31,
2022 and 2021, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make
estimates and judgments that affect the reported amounts of assets, liabilities, and expenses. On an on-going basis, we evaluate our critical
accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to
be reasonable in the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities
that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions.
Our significant accounting
policies are described in the notes to our consolidated financial statements for the years ended December 31, 2022, and 2021, included
in our Form 10-K for the year ended December 31, 2022, filed on March 13, 2023, and there have been no significant changes to
our significant accounting policies during the three months ended March 31, 2023. These unaudited condensed interim consolidated financial
statements should be read in conjunction with the Company’s audited financial statements and accompanying notes.
Recently Issued Accounting Pronouncements
See the sections titled “ Recently
adopted accounting pronouncements” in Note 2 (cc) and “Recently issued accounting pronouncements not yet adopted ”
in Note 2 (dd) to the Company’s consolidated financial statements for the years ended December 31, 2022 and 2021, respectively,
appearing in the Company’s 10-K filed with the SEC on March 13, 2023; and in Note 2 (h) to the Company’s unaudited
condensed interim consolidated financial statements for the three months ended March 31, 2023 and 2022.
Item 3. Quantitative
and Qualitative Disclosures About Market Risk.
As a Smaller Reporting Company,
we are exempt from the requirements of Item 3.
Item 4. Controls
and Procedures.
Our management, with the participation
of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively),
evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2023. The term “disclosure controls and procedures,”
as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act,
means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in
the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified
in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated
and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate
to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed
and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating
the cost-benefit relationship of possible controls and procedures.
34
Based on the evaluation
of our disclosure controls and procedures as of March 31, 2023, our Chief Executive Officer and Chief Financial Officer concluded that,
as of such date, we identified material weaknesses in our internal controls over financial reporting because we did not have a formal
process for period end financial closing and reporting, we historically had insufficient resources to conduct an effective monitoring
and oversight function independent from our operations and we lack accounting resources and personnel to properly account for accounting
transactions such as the issuance of warrants with a derivative liability component. In particular, the material weaknesses identified
were:
●
a lack of accounting resources
required to fulfill US GAAP and SEC reporting requirements;
●
a lack of comprehensive
US GAAP accounting policies and financial reporting procedures and personnel;
●
a lack of adequate procedures
and controls to appropriately account for accounting transactions including liability and the valuation allowance on the deferred
tax asset relating to the net operating losses; and
●
a lack of segregation of
duties given the size of our finance and accounting team.
We have implemented and are continuing to implement
various measures to address the material weaknesses identified; these measures include:
●
as of June 30, 2022, upon
separation with our former Chief Financial Officer, our Director of Financial Reporting, a CPA (Illinois) in 2021 who is experienced
with public company reporting and is conversant in US GAAP and SEC accounting issues, was promoted to Interim Chief Financial Officer.
Effective January 1, 2023, our Interim Chief Financial Officer was promoted to our full time Chief Financial Officer. With this hire
we are continuing to address our ongoing development of our comprehensive US GAAP accounting policies, financial reporting procedures
and internal controls over financial reporting;
●
retaining independent US
GAAP consulting services to assist with the accounting treatment of complex financial instruments; and
●
engaged an independent
US based tax consulting firm.
A significant deficiency
is a control deficiency, or a combination of control deficiencies, that adversely affects our ability to initiate, authorize, record,
process, or report external financial data reliably in accordance with US GAAP such that there is more than a remote likelihood that
a misstatement of our annual or interim financial statements that is more than inconsequential will not be prevented or detected by our
employees.
A material weakness is a
significant deficiency, or combination of significant deficiencies, that results in more than a remote likelihood that a material misstatement
of our annual or interim financial statements will not be prevented or detected by our employees. In response, we have begun the process
of evaluating our internal control over financial reporting and to address the material weaknesses identified.
We intend to continue to take
steps to remediate the material weaknesses described above and further evolve our accounting processes, controls, and reviews. We plan
to continue to assess our internal controls and procedures and intend to take further action as necessary or appropriate to address any
other matters we identify or are brought to our attention. However, our efforts to remediate may be limited or delayed by our financial
condition and limited resources.
The actions that we are taking
are subject to ongoing senior management review, as well as audit committee oversight. We will not be able to conclude whether the steps
we are taking will fully remediate the material weaknesses in our internal controls over financial reporting until we have completed our
remediation efforts and subsequent evaluation of their effectiveness. We may also conclude that additional measures may be required to
remediate the material weaknesses in our internal controls over financial reporting, which may necessitate further action.
Changes in Internal Control Over Financial
Reporting
There have been no changes
in the Company’s internal controls over financial reporting during the quarter ended March 31, 2023, that have materially affected,
or are reasonably likely to materially affect, the Company’s internal control over financial reporting other than as described
above.
35
PART II – OTHER
INFORMATION
Item 1. Legal Proceedings
From time to time in the
future, we may become involved in litigation or other legal proceedings that arise in the ordinary course of business. We are not currently
party to any legal proceedings, and we are not aware of any pending or threatened litigation against us that we believe could have a
material adverse effect on our business, operating results or financial condition. In the event we are subject to a legal proceeding,
it could have a material adverse impact on us because of litigation costs and diversion of management resources.
Item 1A. Risk Factors.
An investment in our common
stock involves a high degree of risk. You should carefully consider the risks set forth in the section captioned “Risk Factors”
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on March 13, 2023, before making
an investment decision. If any of the risks occur, our business, financial condition or results of operations could suffer. In that case,
the trading price of our common stock could decline, and you may lose all or part of your investment. You should read the section captioned
“Forward Looking Statements” above for a discussion of what types of statements are forward-looking statements, as well as
the significance of such statements in the context of this report.
Risks Related to Our Business
We are in default under our license agreement
with Novartis.
Pursuant to a license agreement
with Novartis and our wholly-owned subsidiary Allarity Therapeutics Europe ApS dated April 6, 2018, we have the right to use dovitinib
used in combination with stenoparib to address the second-line or later treatment of metastatic ovarian cancer. Under the terms of the
license agreement, we are required to make certain milestone payments, including a payment of $1,500,000 which was due on April 1, 2023.
We did not make that milestone payment, and on April 4, 2023, we received notice from Novartis stating that Allarity Therapeutics Europe
ApS is in breach of the license agreement and has 30 days from April 4, 2023, to cure. As of May 1, 2023, Novartis has been paid $100,000
towards the current milestone payable of $1,500. We intend to cure this breach by making the milestone payment from proceeds of future
financings and/or working with Novartis on an alternate payment structure. There is no assurance that we will be successful in raising
the required funds to make the milestone payments or that we will be able to come to an agreement on an alternate payment arrangement.
If we fail to make this payment or are otherwise in breach of the license agreement, we may lose our right to use dovitinib which will
adversely affect our ability to conduct our clinical trials and to achieve our business objectives and adversely affect our financial
results.
We have insufficient cash to continue our operations,
our continued operations are dependent on us raising capital and these conditions give rise to substantial doubt over the Company’s
ability continue as a going concern
As of March 31, 2023, we had
$295,000 in cash, and an accumulated deficit of $85.9 million. We had a working capital deficit of $8.6 million. On April 21, 2023,
the Company completed an equity financing and received net proceeds of approximately $1.9 million, which has been determined to be insufficient
to fund the Company’s operations for longer than approximately three months. We believe that our existing cash and cash equivalents
as of May 11, 2023, and our anticipated expenditures and commitments for the next twelve months, will not enable us to fund our operating
expenses and capital expenditure requirements for the twelve months from the date of this Report. These conditions give rise to substantial
doubt over the Company’s ability to continue as a going concern. We will need to raise additional capital after to support our operations
and execute on our business plan. We will be required to pursue sources of additional capital through various means, including debt or
equity financings. Any new securities that we may issue in the future may be sold on terms more favorable for our new investors than the
terms on which our stockholders acquired our securities. Newly issued securities may include preferences, superior voting rights, and
the issuance of warrants or other convertible securities that will have additional dilutive effects. We cannot assure that additional
funds will be available when needed from any source or, if available, will be available on terms that are acceptable to us and may cause
existing shareholders both book value and ownership dilution. Further, we may incur substantial costs in pursuing future capital and/or
financing, including investment banking fees, legal fees, accounting fees, printing and distribution expenses and other costs. We may
also be required to recognize non-cash expenses in connection with certain securities we may issue, such as convertible notes and warrants,
which will adversely impact our financial condition and results of operations. Our ability to obtain needed financing may be impaired
by such factors as the weakness of capital markets, and the fact that we have not been profitable, which could impact the availability
and cost of future financings. If the amount of capital we are able to raise from financing activities is not sufficient to satisfy our
capital needs, we may have to reduce our operations accordingly.
36
Risks Related to Our Securities
We currently do not satisfy The Nasdaq
Global Market continued listing requirements and if we fail to regain compliance our Common Stock will be delisted.
The listing of our common
stock on The Nasdaq Global Market is contingent on our compliance with The Nasdaq Global Market’s conditions for continued listing.
On April 20, 2022, we received notice from the Nasdaq Listing Qualifications stating that because we had not yet filed our Annual Report
on Form 10-K for the year ended December 31, 2021 (the “Form 10-K”) by its due date, we were no longer in compliance with
the listing requirement which requires listed companies to timely file all required periodic financial reports with the SEC. On May 17,
2022, we filed our Form 10-K with the SEC. Subsequent to the filing of the Form 10-K, we were late in filing our Form 10-Q for the quarterly
periods ended March 31, 2022, and June 30, 2022.
On October 12, 2022, we received
a letter from Nasdaq Listing Qualifications notifying us that the Company’s stockholders’ equity as reported in its Quarterly
Report on Form 10-Q for the period ended June 30, 2022 (the “Form 10-Q”), did not satisfy the continued listing requirement
under Nasdaq Listing Rule 5450(b)(1)(A) for The Nasdaq Global Market, which requires that a listed company’s stockholders’
equity be at least $10.0 million. As reported on the Form 10-Q, the Company’s stockholders’ equity as of June 30, 2022, was
approximately $8.0 million. Pursuant to the letter, we were required to submit a plan to regain compliance with Nasdaq Listing Rule 5450(b)(1)(A)
by November 26, 2022. After discussions with the Nasdaq Listing Qualifications staff, on December 12, 2022, we filed a plan to regain
and demonstrate long-term Nasdaq Listing Qualifications compliance including seeking to phase-down to The Nasdaq Capital Market. On December
21, 2022, we received notification from the Nasdaq Listing Qualifications staff that they have granted us an extension of time until
April 10, 2023, to regain and evidence compliance with Nasdaq Listing Rule 5450(b)(1)(A). On April 11, 2023, we received notification
from the Nasdaq Listing Qualifications staff that it has determined that the Company did not meet the terms of the extension. Specifically,
the Company did not complete its proposed transactions and was unable to file a Form 8-K by the April 10, 2023 deadline, evidencing compliance
with Nasdaq Listing Rule 5450(b)(1)(A). As a result, the Company’s Common Stock will be delisted from The Nasdaq Global Market.
In that regard, unless the Company requests an appeal of such determination by April 18, 2023, trading of the Company’s Common
Stock will be suspended at the opening of business on April 20, 2023, and a Form 25-NSE will be filed with the SEC which will remove
the Company’s Common Stock from listing and registration on The Nasdaq Stock Market. The Company has filed its appeal with Nasdaq
and has received a hearing date of May 18, 2023.
On November 21, 2022, the
Company received written notice from Nasdaq Listing Qualifications indicating that the Company is not in compliance with the minimum
bid price requirement of $1.00 per share under the Nasdaq Listing Rules. Based on the closing bid price of the Company’s listed
securities for the last 30 consecutive business days from October 10, 2022 to November 18, 2022, the Company no longer met the minimum
bid price requirement set forth in Listing Rule 5550(a)(2). Under Nasdaq Listing Rules, we are provided with a compliance period of 180
calendar days, or until May 22, 2023, to regain compliance under the Nasdaq Listing Rules. In the event we do not regain compliance by
May 22, 2023, we may be eligible for additional time to regain compliance. On March 24, 2023, we effected the 1-for-35 Share Consolidation
of our common stock in order to attempt to meet the minimum bid requirement of $1.00 per share. Based on discussions on or around April
13, 2023, with Nasdaq, the Nasdaq staff indicated that it would continue to monitor the Company’s ongoing compliance with the minimum
bid price requirement.
On December 20, 2022, we
received a written notice from Nasdaq Listing Qualifications indicating that we are not in compliance with the minimum Market Value of
Publicly Held Shares (“MVPHS”) of $5,000,000 requirement under the Nasdaq Listing Rules Based on our MVPHS for the thirty-one
(31) consecutive business days from November 4, 2022 to December 19, 2022, we no longer meets the minimum MVPHS requirement set forth
in Listing Rule 5450(b)(1)(C). Under Nasdaq Listing Rules, we are provided with a compliance period of 180 calendar days, or until June
19, 2023 to regain compliance. To regain compliance under Nasdaq Listing Rules, our MVPHS must close at $5,000,000 for a minimum of ten
(10) consecutive business days. In the event we do not regain compliance by June 19, 2023, we may face delisting.
On February 8, 2023, we received
notice from Nasdaq Listing Qualifications stating that due to the resignation of Soren G. Jensen from the Company’s board and audit
committee, effective on February 4, 2023, the Company no longer complies with Nasdaq’s Listing Rules’ independent director
and audit committee requirements as set forth in Nasdaq Listing Rules 5605(b)(1)(A) and 5605(c)(4) which requires a majority of the board
of directors to be comprised of independent directors and an audit committee of at least three independent directors. The February 8,
2023 Nasdaq Listing Qualification notice has no immediate effect on the listing or trading of the Company’s common stock on the
Nasdaq Global Market. In accordance with Nasdaq Listing Rules, we have a cure period to regain compliance as follows: (i) until the earlier
of the Company’s next annual shareholders’ meeting or February 4, 2024; or (ii) if the next annual shareholders’ meeting
is held before August 3, 2023, then the Company must evidence compliance no later than August 3, 2023. The Company’s board is currently
seeking to appoint a new independent director who will also qualify under the Nasdaq Listing Rules to serve as a member of the audit
committee, and intends to regain compliance with the Nasdaq Listing Rules as soon as practicable.
37
If we fail to meet the Nasdaq
listing requirements and do not regain compliance, we will be subject to delisting by Nasdaq. If the Nasdaq staff determines to seek
the delisting our common stock on the Nasdaq, we intend to appeal such determination before the Nasdaq Hearing Panel. In the event our
common stock is no longer listed for trading on The Nasdaq Global Market and we are unable to transfer to The Nasdaq Capital Market,
our trading volume and share price may decrease and you may have a difficult time selling your shares of common stock. In addition, we
may experience difficulties in raising capital which could materially adversely affect our operations and financial results. Further,
delisting from Nasdaq markets could also have other negative effects, including potential loss of confidence by partners, lenders, suppliers
and employees. Finally, delisting could make it harder for our stockholders and the Company to sell the securities and hard for us to
raise capital.
We received a request for documents from
the SEC in the investigation known as “In the Matter of Allarity Therapeutics, Inc.,” and, separately, a letter from Nasdaq,
regarding the same matter, the consequences of which are unknown.
In January 2023, we received
a request to produce documents from the SEC that stated that the staff of the SEC is conducting an investigation known as “In the
Matter of Allarity Therapeutics, Inc.” to determine if violations of the federal securities laws have occurred. The documents requested
appear to focus on submissions, communications and meetings with the FDA regarding our NDA for Dovitinib or Dovitinib-DRP. The SEC letter
also stated that investigation is a fact-finding inquiry and does not mean that that the SEC has concluded that the Company or anyone
else has violated the laws. As a result of the disclosure of the SEC request, the Nasdaq staff has requested us to provide them with the
information requested by the SEC in which we are complying. We do not know when the SEC’s or Nasdaq’s investigation will be
concluded or what action, if any, might be taken in the future by the SEC, Nasdaq or their staff as a result of the matters that are the
subject to its investigation or what impact, if any, the cost of continuing to respond to inquiries might have on our financial position
or results of operations. We have not established any provision for losses in respect of this matter. In addition, complying with any
such future requests by the SEC or Nasdaq for documents or testimony would distract the time and attention of our officers and directors
or divert our resources away from ongoing business matters. This investigation may result in significant legal expenses, the diversion
of management’s attention from our business, could cause damage to our business and reputation, and could subject us to a wide range
of remedies, including enforcement actions by the SEC or delisting proceedings by Nasdaq. There can be no assurance that any final resolution
of this or any similar matters will not have a material adverse effect on our financial condition or results of operations.
Future sales, or the perception of future
sales, by us or our stockholders in the public market could cause the market price for our common stock to decline.
The sale of shares of our
common stock in the public market, or the perception that such sales could occur, could harm the prevailing market price of shares of
our common stock. These sales, or the possibility that these sales may occur, also might make it more difficult for our stockholders to
sell our common stock or for us to sell equity securities in the future at a time and at a price that it deems appropriate. As of May
9, 2023, we had 6,311 shares of Series A Preferred Stock outstanding that can be converted into 9,087,840 shares of our common stock and
we have warrants that can be exercised for 22,603,385 shares of our common stock. The holder of the Series A Preferred Stock, and holders
of our warrants may convert, exercise or exchange their securities into shares of common stock which sales thereof could adversely affect
the market price of shares of our common stock, and dilute stockholders ownership of our common stock.
Item 2. Unregistered
Sales of Equity Securities and Use of Proceeds.
Pursuant to the Securities
Purchase Agreement with 3i, LP, a Delaware limited partnership (the “Investor”), we issued 20,000 shares of our Series A Preferred
Stock and a warrant to purchase 2,018,958 shares of common stock at an initial exercise price of $9.9061 (the “PIPE Warrant”)
to the Investor for an aggregate purchase price of $20 million. On April 20, 2023, we entered into a certain Modification and Exchange
with the Investor pursuant to which we agreed to, among other things, subject to the Offering Closing, (i) amend the Certificate of Designations
for the Series A Convertible Preferred Stock (the “Amended COD”), which among other things, eliminates the Series A Preferred
Stock redemption right and dividend (except for certain exceptions as specified in the Amended COD), and provides for the conversion of
Series A Preferred Stock into Common Stock at a conversion price of $0.75 which is equal to the price for a share of Common Stock sold
in the Offering, (ii) exchange 50,000 shares of Series C Preferred Stock (the “Series C Shares”) beneficially owned by 3i
for 4,027 shares of Series A Preferred Stock (the “Exchange Shares”), (iii) the PIPE Warrant for a new warrant (the “Exchange
Warrant”), which reflects an exercise price of $0.75 and represents a right to acquire 12,603,385 shares of Common Stock. On April
21, 2023, the closing of the transactions contemplated by the Exchange Agreement occurred and the Exchange Warrant and the Exchange Shares
were issued to 3i, and the Original Warrant and the Series C Shares were cancelled.
38
On February 28, 2023, we entered into a Securities Purchase Agreement
with the Investor for the purchase and sale of 50,000 shares of Series C Preferred Stock, at a purchase price of $24.00 per share, for
a subscription receivable in the aggregate amount equal to the total purchase price of $1.2 million.
Pursuant to a series of exercise
of conversion of Series A Preferred Stock by the Investor, during the three months ended March 31, 2023, we issued 721,462 shares of
Common Stock to the Investor upon the conversion of 3,838 shares of Series A Preferred Stock (the “Conversion Shares”). No
proceeds were received by the Company upon such conversions.
The offers, sales, and issuances
of the Conversion Shares, the Series C Shares, Series A Preferred Stock and PIPE Warrant to the Investor described above were deemed
to be exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Rule 506 of Regulation
D promulgated thereunder as transactions by an issuer not involving a public offering. Each of the recipients of securities in these
transactions was an accredited investor within the meaning of Rule 501 of Regulation D under the Securities Act.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
39
Item 6. Exhibits
The following exhibits are filed as part of this
Report.
Exhibit
No.
Description
3.1 (b)
Certificate of Designation of Preferences, Rights and
Limitations of Series C Convertible Redeemable Preferred Stock
3.2 (b)
Certificate of Amendment to Certificate of Designation
of Preferences, Rights and Limitations of Series C Convertible Redeemable Preferred Stock
3.3 (d)
Second Certificate of Amendment to Certificate of Incorporation
of Allarity Therapeutics, Inc.
3.4 (e)
Third Certificate of Amendment of Certificate of Incorporation
of Allarity Therapeutics, Inc.
3.5 (h)
Amended and Restated Certificate of Designations of
Series A Convertible Preferred Stock of Allarity Therapeutics, Inc.
4.1 (h)
Form of Pre-Funded Warrant
4.2 (h)
Form of Common Warrant
10.1# (a)
Employment Agreement with James G. Cullem dated January
12 ,2023
10.2# (a)
Employment Agreement with Joan Brown dated January
12, 2023
10.3 (c)
Letter Agreement with 3i, LP dated January 23, 2023
10.4+ (b)
Form of Securities Purchase Agreement – Series
C Preferred Stock
10.5 (b)
Form of Registration Rights Agreement
10.6 (b)
Limited Waiver Agreement
10.7+ (h)
Securities Purchase Agreement
10.8 (f)
Form of Lock-Up
10.9 (g)
First Amendment to Secured Note Purchase Agreement
10.10 (g)
First Amendment to Security Agreement
10.11 (g)
Form of Secured Promissory Note (2023)
10.12 (h)
Secured Promissory Note
10.13 (h)
Modification and Exchange Agreement
10.14 (h)
Cancellation of Debt Agreement
10.15 (h)
First Amendment to Registration Rights Agreement
10.16 (h)
Limited Waiver Agreement
31.1*
Certifications of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act
31.2*
Certifications of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act
32.1*
Certifications of the Chief Executive Officer under Section 906 of the Sarbanes-Oxley Act
32.2*
Certifications of the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act
101.INS*
Inline XBRL Instance Document.
101.SCH*
Inline XBRL Taxonomy Extension Schema Document.
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase
Document.
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase
Document.
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase
Document.
104*
Cover Page Interactive Data File (formatted as Inline
XBRL and contained in Exhibit 101).
(a)
Incorporated by reference from Form 8-K filed with
the SEC on January 19, 2023.
(b)
Incorporated by reference from Form 8-K filed with
the SEC on February 28, 2023
(c)
Incorporated by reference from Form 10-K filed with
the SEC on March 13, 2023.
(d)
Incorporated by reference from Form 8-K filed with
the SEC on March 20, 2023.
(e)
Incorporated by reference from Form 8-K filed with
the SEC on March 24, 2023.
(f)
Incorporated by reference from Form S-1 filed with
the SEC on March 28, 2023.
(g)
Incorporated by reference from Form 8-K filed with
the SEC on April 12, 2023.
(h)
Incorporated by reference from Form 8-K filed with
the SEC on April 25, 2023.
+
Certain of the exhibits and schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601. The Registrant agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request.
#
Indicates management contract or compensatory plan or arrangement.
*
Filed herewith.
40
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.
ALLARITY THERAPEUTICS, INC.,
A Delaware Corporation
Date: May 11, 2023
By:
/s/ James Cullem
Name:
James Cullem
Title:
Chief Executive Officer
(Principal Executive Officer)
Date: May 11, 2023
By:
/s/ Joan Brown
Name:
Joan Brown
Title:
Chief Financial Officer
(Principal Financial and Accounting Officer)
41
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.