UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 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 June 30, 2022
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _________to ___________
Commission
File Number: 001-41159
IMMIX
BIOPHARMA, INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware
45-4869378
(State
or other jurisdiction
of
incorporation or organization)
(I.R.S.
Employer
Identification
No.)
11400
West Olympic Blvd. , Suite 200 , Los Angeles , CA
90064
(Address
of principal executive offices)
(Zip
Code)
(310)
651-8041
(Registrant’s
telephone number, including area code)
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, $0.0001 par value
IMMX
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 registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
☒
Number
of common stock outstanding as of August 11, 2022 was 13,910,118 .
Page
No.
PART
I. FINANCIAL INFORMATION
Item
1.
Financial Statements (Unaudited)
5
Condensed Consolidated Balance Sheets as of June 30, 2022 and December 31, 2021
5
Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months ended June 30, 2022 and 2021
6
Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the Three and Six Months ended June 30, 2022 and 2021
7
Condensed Consolidated Statements of Cash Flows for the Six Months ended June 30, 2022 and 2021
8
Notes to the Condensed Consolidated Financial Statements
9
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
15
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
19
Item
4.
Controls and Procedures
19
PART II. OTHER INFORMATION
Item
1.
Legal Proceedings
19
Item
1A.
Risk Factors
19
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
20
Item
3.
Defaults Upon Senior Securities
20
Item
4.
Mine Safety Disclosures
20
Item
5.
Other Information
20
Item
6.
Exhibits
20
Signatures
21
2
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This
Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions 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”). These statements may be identified by such forward-looking terminology as “may,”
“should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other
comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections
about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually
achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially
from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements
involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:
●
our
projected financial position and estimated cash burn rate;
●
our
estimates regarding expenses, future revenues and capital requirements;
●
our
ability to continue as a going concern;
●
our
need to raise substantial additional capital to fund our operations;
●
the
success, cost and timing of our clinical trials;
●
our
dependence on third parties in the conduct of our clinical trials;
●
our
ability to obtain the necessary regulatory approvals to market and commercialize our product candidates;
●
the
ultimate impact of the ongoing COVID-19 pandemic, or any other health epidemic, on our business, our clinical trials, our research
programs, healthcare systems or the global economy as a whole;
●
the
potential that results of pre-clinical and clinical trials indicate our current product candidates or any future product candidates
we may seek to develop are unsafe or ineffective;
●
the
results of market research conducted by us or others;
●
our
ability to obtain and maintain intellectual property protection for our current and future product candidates;
●
our
ability to protect our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce
or protect our intellectual property rights;
●
the
possibility that a third party may claim we or our third-party licensors have infringed, misappropriated or otherwise violated their
intellectual property rights and that we may incur substantial costs and be required to devote substantial time defending against
claims against us;
●
our
reliance on third-party suppliers and manufacturers;
●
the
success of competing therapies and products that are or become available;
●
our
ability to expand our organization to accommodate potential growth and our ability to retain and attract key personnel;
●
the
potential for us to incur substantial costs resulting from product liability lawsuits against us and the potential for these product
liability lawsuits to cause us to limit our commercialization of our product candidates;
3
●
market
acceptance of our product candidates, the size and growth of the potential markets for our current product candidates and any future
product candidates we may seek to develop, and our ability to serve those markets; and
●
the
successful development of our commercialization capabilities, including sales and marketing capabilities.
All
of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ
materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will
prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties
referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other
documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially
and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake
or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or
projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form
10-Q, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public
statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements
contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form
10-Q.
This
Quarterly Report on Form 10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company
surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications,
articles and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained
therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed.
While we believe that such studies and publications are reliable, we have not independently verified market and industry data from third-party
sources.
4
ITEM
1. FINANCIAL STATEMENTS.
Immix
Biopharma, Inc.
Condensed
Consolidated Balance Sheets
June 30, 2022
December 31, 2021
(Unaudited)
ASSETS
Current assets:
Cash
$ 18,402,351
$ 17,644,478
Tax receivable
165,048
25,722
Prepaid expenses and other current assets
515,948
516,193
Total current assets
19,083,347
18,186,393
Equipment, net
4,691
5,695
Total assets
$ 19,088,038
$ 18,192,088
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses
$ 977,209
$ 142,940
Accrued interest
-
9,099
Note payable
-
50,000
Total current liabilities
977,209
202,039
Total liabilities
977,209
202,039
Commitments and contingencies (Note 5)
Stockholders’ equity:
Preferred stock, par value $ 0.0001 ; 10,000,000
shares authorized at June 30, 2022 and December 31, 2021; no shares
issued and outstanding
-
-
Common stock, par value $ 0.0001 ,
200,000,000 shares authorized at June 30, 2022
and December 31, 2021; 13,947,536 shares issued
and 13,910,118 shares outstanding at June
30, 2022, and 13,228,689 shares issued and
outstanding at December 31, 2021
1,395
1,323
Additional paid-in capital
50,713,313
47,618,852
Accumulated other comprehensive income
102,444
125,408
Accumulated deficit
( 32,650,360 )
( 29,755,534 )
Treasury stock at cost, 37,418 and no shares as of June 30, 2022 and December 31, 2021, respectively
( 55,963 )
-
Stockholders’ equity
18,110,829
17,990,049
Total liabilities and stockholders’ equity
$ 19,088,038
$ 18,192,088
See
accompanying notes to the unaudited condensed consolidated financial statements.
5
Immix
Biopharma, Inc.
Condensed
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2022
2021
2022
2021
Operating expenses:
General and administrative expenses
$ 953,203
$ 180,404
$ 1,653,710
$ 318,084
Research and development
607,751
62,761
1,237,282
87,601
Total operating expenses
1,560,954
243,165
2,890,992
405,685
Loss from operations
( 1,560,954 )
( 243,165 )
( 2,890,992 )
( 405,685 )
Other income (expense):
Change in fair value of derivative liability
-
( 90,000 )
-
( 735,000 )
Interest expense
( 109 )
( 53,865 )
( 497 )
( 81,409 )
Total other expense, net
( 109 )
( 36,135 )
( 497 )
( 816,409 )
Loss before provision for income taxes
( 1,561,063 )
( 207,030 )
( 2,891,489 )
( 1,222,094 )
Provision for income taxes
1,715
1,608
3,337
3,199
Net loss
( 1,562,778 )
( 208,638 )
( 2,894,826 )
( 1,225,293 )
Other comprehensive income (loss):
Foreign currency translation
( 38,551 )
4,698
( 22,964 )
( 4,472 )
Total other comprehensive income (loss)
( 38,551 )
4,698
( 22,964 )
( 4,472 )
Comprehensive loss
$ ( 1,601,329 )
$ ( 203,940 )
$ ( 2,917,790 )
$ ( 1,229,765 )
Loss per common share - basic and diluted
$ ( 0.11 )
$ ( 0.06 )
$ ( 0.21 )
$ ( 0.36 )
Weighted average shares outstanding - basic and diluted
13,881,414
3,375,000
13,856,052
3,375,000
See
accompanying notes to the unaudited condensed consolidated financial statements.
6
Immix
Biopharma, Inc.
Condensed
Consolidated Statements of Stockholders’ Equity (Deficit)
For
the Three and Six Months Ended June 30, 2022 and 2021
(Unaudited)
Common
Additional
Accumulated Other
Treasury
Total Stockholders’
Common
Stock
Paid-in
Comprehensive
Accumulated
Treasury
Stock
Equity
Shares
Amount
Capital
Income
Deficit
Shares
Amount
(Deficit)
Balance December 31, 2021
13,228,689
$ 1,323
$ 47,618,852
$ 125,408
$ ( 29,755,534 )
-
$ -
$ 17,990,049
Shares issued for cash proceeds, net of offering costs
630,000
63
2,913,687
-
-
-
-
2,913,750
Stock-based compensation
-
-
65,074
-
-
-
-
65,074
Net loss
-
-
-
-
( 1,332,048 )
-
-
( 1,332,048 )
Foreign currency translation adjustment
-
-
-
15,587
-
-
-
15,587
Balance March 31, 2022
13,858,689
1,386
50,597,613
140,995
( 31,087,582 )
-
-
19,652,412
Shares issued for cashless exercise of stock options
62,532
6
( 6 )
-
-
-
-
-
Stock-based compensation
-
-
65,709
-
-
-
-
65,709
Shares issued for services
26,315
3
49,997
-
-
-
-
50,000
Repurchase of common shares
-
-
-
-
-
37,418
( 55,963 )
( 55,963 )
Net loss
-
-
-
-
( 1,562,778 )
-
-
( 1,562,778 )
Foreign currency translation adjustment
-
-
-
( 38,551 )
-
-
-
( 38,551 )
Balance June 30, 2022
13,947,536
$ 1,395
$ 50,713,313
$ 102,444
$ ( 32,650,360 )
37,418
$ ( 55,963 )
$ 18,110,829
Balance December 31, 2020
3,375,000
$ 338
$ 508,872
$ 131,861
$ ( 5,371,655 )
-
-
$ ( 4,730,584 )
Relative fair value of warrants issued in connection with debt
-
-
42,764
-
-
-
-
42,764
Stock-based compensation
-
-
4,247
-
-
-
-
4,247
Net loss
-
-
-
-
( 1,016,655 )
-
-
( 1,016,655 )
Foreign currency translation adjustment
-
-
-
( 9,170 )
-
-
-
( 9,170 )
Balance March 31, 2021
3,375,000
338
555,883
122,691
( 6,388,310 )
-
-
( 5,709,398 )
Relative fair value of warrants issued in connection with debt
-
-
31,839
-
-
-
-
31,839
Stock-based compensation
-
-
30,724
-
-
-
-
30,724
Net loss
-
-
-
-
( 208,638 )
-
-
( 208,638 )
Foreign currency translation adjustment
-
-
-
4,698
-
-
-
4,698
Balance June 30, 2021
3,375,000
$ 338
$ 618,446
$ 127,389
$ ( 6,596,948 )
-
$ -
$ ( 5,850,775 )
See
accompanying notes to the unaudited condensed consolidated financial statements.
7
Immix
Biopharma, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
For the Six Months Ended
June 30,
2022
2021
Operating Activities:
Net loss
$ ( 2,894,826 )
$ ( 1,225,293 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
130,783
34,971
Shares issued for services
50,000
-
Convertible note issued in exchange for services
-
60,000
Change in fair value of derivative liability
-
735,000
Amortization of debt discount
-
21,417
Depreciation
1,003
1,228
Changes in operating assets and liabilities:
Tax receivable
( 146,177 )
( 51,636 )
Prepaid expenses and other current assets
( 11,059 )
6,563
Accounts payable and accrued expenses
837,487
( 66,633 )
Accrued interest
( 9,099 )
59,929
Net cash used in operating activities
( 2,041,888 )
( 424,454 )
Investing Activities:
Purchase of equipment
-
( 802 )
Net cash used in investing activities
-
( 802 )
Financing Activities:
Proceeds from convertible notes payable
-
200,000
Payments on note payable
( 50,000 )
-
Payments of deferred offering costs
-
( 52,673 )
Proceeds from sale of common stock, net of offering costs
2,913,750
-
Repurchase of common stock
( 55,963 )
-
Net cash provided by financing activities
2,807,787
147,327
Effect of foreign currency on cash
( 8,026 )
( 2,556 )
Net change in cash
757,873
( 280,485 )
Cash – beginning of period
17,644,478
391,086
Cash – end of period
$ 18,402,351
$ 110,601
Supplemental Disclosures of Cash Flow Information:
Interest paid
$ 9,596
$ 63
Income taxes paid
$ -
$ -
Supplemental Disclosures of Noncash Financing Information:
Common stock issued for cashless exercise of stock options
$ 6
$ -
Relative fair value of warrants issued in connection with convertible debt
$ -
$ 74,603
Debt discount related to derivative liabilities
$ -
$ 80,000
See
accompanying notes to the unaudited condensed consolidated financial statements.
8
Immix
Biopharma, Inc.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited)
Note
1 – Nature of Business
Immix
Biopharma, Inc. (the “Company”) is a clinical-stage pharmaceutical company organized as a Delaware corporation on January
7, 2014 to focus on the development of safe and effective therapies for patients with cancer and inflammatory diseases. In August 2016,
the Company established a wholly-owned Australian subsidiary, Immix Biopharma Australia Pty Ltd. (“IBAPL”), in order to conduct
various preclinical and clinical activities for its development candidates.
Note
2 – Summary of Significant Accounting Policies
The
accompanying condensed consolidated financial statements and related notes have been prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”) and in accordance with the rules and regulations of the
United States Securities and Exchange Commission (the “SEC”). The Company’s fiscal year end is December 31.
The
condensed consolidated financial statements and related disclosures as of June 30, 2022 and for the three and six months ended June 30,
2022 and 2021 are unaudited, pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally
included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations.
In the Company’s opinion, these unaudited condensed consolidated financial statements include all adjustments (consisting only
of normal recurring adjustments) necessary for the fair statement of the results for the interim periods. These unaudited condensed consolidated
financial statements should be read in conjunction with the audited financial statements of the Company for the years ended December
31, 2021 and 2020 which are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2022. The results
of operations for the six months ended June 30, 2022 are not necessarily indicative of the results to be expected for the full year ending
December 31, 2022.
Risk
and Uncertainties – The Company operates in a dynamic and highly competitive industry and is subject to risks and uncertainties
common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological
innovations, protection of proprietary technology, dependence on key personnel, contract manufacturer and contract research organizations,
compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under
development will require significant additional research and development efforts, including extensive preclinical studies and clinical
trials and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate
personnel infrastructure and extensive compliance and reporting. The Company believes that changes in any of the following areas could
have a material adverse effect on the Company’s future financial position, results of operations, or cash flows: ability to obtain
future financing; advances and trends in new technologies and industry standards; results of clinical trials; regulatory approval and
market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims
against the Company based on intellectual property, patent, product, regulatory, or other factors; and the Company’s ability to
attract and retain employees necessary to support its growth.
Products
developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory
agencies prior to commercial sales. There can be no assurance that the Company’s research and development will be successfully
completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that the products will
receive the necessary approvals, or that any approved products will be commercially viable. If the Company was denied approval, approval
was delayed or the Company was unable to maintain approval, it could have a material adverse impact on the Company. Even if the Company’s
product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The
Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology
companies. In addition, the Company is dependent upon the services of its employees, consultants and other third parties.
Beginning
in late 2019, the outbreak of a novel strain of virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus,
which causes coronavirus disease 2019, or COVID-19, evolved into a global pandemic. The extent of the impact of the coronavirus outbreak
on the Company’s business will depend on certain developments, including the duration and spread of the outbreak and the extent
and severity of the impact on the Company’s clinical trial activities, research activities and suppliers, all of which are uncertain
and cannot be predicted. At this point, the extent to which the coronavirus outbreak may materially impact the Company’s financial
condition, liquidity or results of operations is uncertain. The Company has expended and will continue to expend substantial funds to
complete the research, development and clinical testing of product candidates. The Company also will be required to expend additional
funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution of products that receive
regulatory approval. The Company may require additional funds to commercialize its products. The Company is unable to entirely fund these
efforts with its current financial resources. If adequate funds are unavailable on a timely basis from operations or additional sources
of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development programs which
would materially and adversely affect its business, financial condition and operations.
9
Use
of Estimates in Financial Statement Presentation – The preparation of these condensed consolidated financial statements in
conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. The Company uses
significant judgements when making estimates related to the valuation of deferred tax assets and related valuation allowances, accrual
and prepayment of research and development expenses, and the valuation of derivative financial instruments. Actual results could differ
from those estimates.
Principles
of Consolidation – The accompanying condensed consolidated financial statements include the accounts of Immix Biopharma, Inc.
and the accounts of its 100 % owned subsidiary, IBAPL. All intercompany transactions and balances have been eliminated in consolidation.
Liquidity
and Going Concern –
These condensed consolidated financial statements have been prepared on a going concern basis, which assumes the Company will continue
to realize its assets and discharge its liabilities in the normal course of business. The continuation of the Company as a going concern
is dependent upon the ability of the Company to obtain financing to continue operations. In December 2021, the Company received $ 18,648,934
in net proceeds from the initial public offering
(“IPO”) of its common stock and in January 2022, the Company raised additional net proceeds of $ 2,913,750 from the exercise
of the underwriter’s over-allotment option in connection with the Company’s IPO. The Company has a history of, and expects
to continue to report, negative cash flows from operations and a net loss. Management believes that its cash on hand at June 30, 2022
will be sufficient to meet the Company’s working capital requirements through at least August 15, 2023.
Concentration
of Credit Risk – Periodically, the Company may carry cash balances at financial institutions in excess of the federally insured
limit of $ 250,000 , or the Australian insured limit of AUD 250,000 . As of June 30, 2022, the Company had $ 18,049,000 in excess of the
FDIC insurance limit and no amounts in excess of the Australian insured limit. The Company has not experienced losses on these accounts
and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is
not significant.
Fair
Value of Financial Instruments – The carrying value of short-term instruments, including cash, tax receivable, accounts payable
and accrued expenses, and notes payable approximate fair value due to the relatively short period to maturity for these instruments.
Fair
value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal
or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The
Company utilizes a three-level valuation hierarchy for disclosures of fair value measurements, defined as follows:
Level
1 – inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level
2 – inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs
that are observable for the assets or liability, either directly or indirectly, for substantially the full term of the financial instruments.
Level
3 – inputs to the valuation methodology are unobservable and significant to the fair value.
As
of June 30, 2022 and December 31, 2021, the Company had no assets or liabilities required to be measured at fair value on a recurring
basis.
Australian
Tax Incentive –- IBAPL is eligible to receive a cash refund from the Australian Taxation Office for eligible research and development
(“R&D”) expenditures under the Australian R&D Tax Incentive Program (the “Australian Tax Incentive”).
The Australian Tax Incentive is recognized as a reduction to R&D expense when there is reasonable assurance that the relevant expenditure
has been incurred, the amount can be reliably measured and that the Australian Tax Incentive will be received. The Company recognized
reductions to R&D expense of $ 110,217 and $ 30,522 for the three months ended June 30, 2022 and 2021, respectively. The Company recognized
reductions to R&D expense of $ 146,177 and $ 51,636 for the six months ended June 30, 2022 and 2021, respectively.
Stock-Based
Compensation – Stock-based compensation expense represents the estimated grant date fair value of the Company’s equity
awards, consisting of stock options issued under the Company’s stock option plan and restricted common stock (see Note 4). The
fair value of equity awards is recognized over the requisite service period of such awards (usually the vesting period) on a straight-line
basis. The Company estimates the fair value of stock options using the Black-Scholes option pricing model on the date of grant and recognizes
forfeitures as they occur. For stock awards for which vesting is subject to performance-based milestones, the expense is recorded over
the remaining service period after the point when the achievement of the milestone is probable, or the performance condition has been
achieved.
Research
and Development Costs –- R&D costs consist primarily of clinical research fees paid to consultants and outside service providers,
and other expenses relating to design, development and testing of the Company’s therapy candidates. R&D costs are expensed
as incurred.
Clinical
trial costs are a component of R&D expenses. The Company estimates expenses incurred for clinical trials that are in process based
on services performed under contractual agreements with clinical research organizations and actual clinical investigators. Included in
the estimates are (1) the fee per patient enrolled as specified in the clinical trial contract with each institution participating in
the clinical trial and (2) progressive data on patient enrollments obtained from participating clinical trial sites and the actual services
performed. Changes in clinical trial assumptions, such as the length of time estimated to enroll all patients, rate of screening failures,
patient drop-out rates, number and nature of adverse event reports, and the total number of patients enrolled can impact the average
and expected cost per patient and the overall cost of the clinical trial. The Company monitors the progress of the trials and their related
activities and adjusts expense accruals, when applicable. Adjustments to accruals are charged to expense in the period in which the facts
give rise to the adjustments become known.
10
Other
Comprehensive Income (Loss) – Other comprehensive income (loss) includes foreign currency translation gains and losses. The
cumulative amount of translation gains and losses are reflected as a separate component of stockholders’ equity in the condensed
consolidated balance sheets, as accumulated other comprehensive income.
Foreign
Currency Translation and Transaction Gains (Losses) –- The Company maintains its accounting records in U.S. Dollars. The Company’s
operating subsidiary, IBAPL, is located in Australia and maintains its accounting records in Australian Dollars, which is its functional
currency. Assets and liabilities of the subsidiary are translated into U.S. dollars at exchange rates at the balance sheet date, equity
accounts are translated at historical exchange rate and revenues and expenses are translated by using the average exchange rates for
the period. Translation adjustments are reported as a separate component of other comprehensive income (loss) in the consolidated statements
of operations and comprehensive loss. Foreign currency denominated transactions are translated at exchange rates approximating those
in effect at the transaction dates. Exchange gains and losses are recognized in operations and were $ 3,523 and $ 941 for the three months
ended June 30, 2022 and 2021, respectively, and $ 4,092 and $ 1,251 for the six months ended June 30, 2022 and 2021, respectively, and
are included in general and administrative expenses in the accompanying condensed consolidated statements of operations and comprehensive
loss.
Loss
Per Common Share - Basic loss per common share is
computed by dividing net loss available to common stockholders by the weighted-average number of common shares outstanding during the
period. Diluted loss per common share is determined using the weighted-average number of common shares outstanding during the period,
adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, the weighted-average number of common
shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive. As of June 30, 2022 and 2021, the
Company’s potentially dilutive shares and options, which were not included in the calculation of net loss per share, included stock
options and warrants exercisable for 1,588,742
and 1,461,984
shares of common stock, respectively.
Recent
Accounting Pronouncements
The
Company does not believe that any recently issued effective pronouncements, or pronouncements issued but not yet effective, if adopted,
would have a material effect on the accompanying condensed consolidated financial statements.
Note
3 – Note Payable
Note
Payable – Related Party
On
September 14, 2014, the Company issued an unsecured promissory note in the principal amount of $ 50,000
(the “Note”) to a stockholder of the Company. The Note matured on September
14, 2017 and accrued interest at 2.5 %
per annum. On June 9, 2021, the Note was amended to extend the maturity date to September
14, 2022 . On May 26, 2022, the Company repaid the outstanding principal balance and accrued interest in full. As of June 30,
2022 and December 31, 2021, the outstanding principal balance on this note was $ 0
and $ 50,000 ,
respectively.
Interest
expense related to the Note was $ 189 and $ 312 for the three months ended June 30, 2022 and 2021, respectively, and $ 497 and $ 620 for the six months
ended June 30, 2022 and 2021, respectively. As of June 30, 2022 and December 31, 2021, accrued interest on the Note was $ 0 and $ 9,099 ,
respectively.
Note
4 – Stockholders’ Equity
The
Company has authorized 200,000,000 shares of common stock and 10,000,000 shares of preferred stock each with a par value of $ 0.0001 per
share.
On
January 5, 2022, the Company sold 630,000 shares of its common stock pursuant to the full exercise of the over-allotment option in connection
with the Company’s IPO. The shares were sold at the IPO price of $ 5.00 per share, resulting in gross proceeds of $ 3,150,000 and
bringing the total gross proceeds of the IPO to $ 24,150,000 . In connection with the exercise of the over-allotment, the Company paid
$ 243,275 in offering costs resulting in net proceeds of $ 2,913,750 and bringing total net proceeds to $ 21,562,684 .
On
May 14, 2022, the Company issued 26,315
shares of its common stock with a fair value
of $ 50,000
for services.
During
the six months ended June 30, 2022, the Company purchased 37,418 shares of its common stock at a cost of $ 55,963 , pursuant to its share
repurchase program. The shares are being held in treasury. The share repurchase plan was approved by the Company’s board of directors
(“Board of Directors” or “Board”) on May 9, 2022 and authorized the repurchase of up to $ 1,000,000 of the Company’s
common stock.
During
the six months ended June 30, 2022, the Company issued 62,532 shares of its common stock upon the cashless exercise of 140,992 stock
options.
11
Stock
Options
In
2016, the Board of Directors of the Company approved the Immix Biopharma, Inc. 2016 Equity Incentive Plan (the “2016
Plan”). The 2016 Plan allows for the Board of Directors to grant various forms of incentive awards for up to 417,120
shares of common stock. During the year ended December 31, 2021, the Board of Directors amended the 2016 Plan to increase the
aggregate number of shares available for issuance under the 2016 Plan to 1,761,120
shares of common stock. On September 10, 2021, the Board of Directors approved the 2021 Equity Incentive Plan (the “2021
Plan”), which reserves and makes available for future issuance under the 2021 Plan (i) 900,000
shares of common stock, plus (ii) the number of shares of common stock reserved, but unissued under the 2016 Plan, and (iii) the
number of shares of common stock underlying forfeited awards under the 2016 Plan, provided that shares of common stock issued under
the 2021 Plan with respect to an Exempt Award (as defined in the 2021 Plan) shall not count against such share limit. Subsequent to
September 10, 2021, no further awards shall be issued under the 2016 Plan, but all awards under the 2016 Plan which are outstanding
as of September 10, 2021 (including any Grandfathered Arrangement (as defined in the 2021 Plan)) shall continue to be governed by the terms, conditions and
procedures set forth in the 2016 Plan and any applicable award agreement. As of June 30, 2022, there are 1,328,886
shares of the Company’s common stock remaining to be issued under the 2021 Plan.
On
January 13, 2022, the Company issued options to purchase 11,250 shares of the Company’s common stock to advisors of the Company
with a term of 10 years and an exercise price of $ 5.83 per share which vest in equal monthly installments over 48 months .
The
Company estimated the fair value of the stock options using the Black-Scholes option pricing model. The fair value of stock options is
being amortized on a straight-line basis over the requisite vesting period of the awards. The fair value of stock options was estimated
using the following assumptions for the six months ended June 30, 2022: an expected and contractual life of 10 years , an assumed volatility
of 118.25 % , a zero dividend rate, and a risk free rate of 1.70 % .
The
Company recognized stock-based compensation of $ 65,709
and $ 30,724
related to stock options for the three months ended June 30, 2022 and 2021, respectively, and $ 130,783
and $ 34,971
related to stock options for the six months ended June 30, 2022 and 2021, respectively, which is included in general and
administrative expenses.
The
following table summarizes the stock option activity for the six months ended June 30, 2022:
Schedule of Stock Option Activity
Options
Weighted-
Average Exercise
Price Per Share
Outstanding and exercisable, January 1, 2022
1,320,984
$ 1.54
Granted
11,250
$ 5.83
Exercised
( 140,992 )
$ 1.33
Forfeited
-
$ -
Expired
-
$ -
Outstanding and expected to vest, June 30, 2022
1,191,242
$ 1.60
The
following table discloses information regarding outstanding and exercisable options at June 30, 2022:
Schedule of Stock Outstanding and Exercisable
Outstanding
Exercisable
Exercise Price
Number of
Option
Shares
Weighted
Average
Exercise Price
Weighted
Average
Remaining
Life (Years)
Number of
Option
Shares
Weighted
Average
Exercise Price
$ 0.80
256,500
$ 0.80
8.70
160,313
$ 0.80
$ 1.33
150,992
$ 1.33
3.17
150,992
$ 1.33
$ 1.86
772,500
$ 1.86
8.98
192,813
$ 1.86
$ 5.83
11,250
$ 5.83
9.55
1,172
$ 5.83
1,191,242
$ 1.60
8.19
505,290
$ 1.38
Aggregate
intrinsic value is calculated as the difference between the exercise price of the underlying stock option and the fair value of the Company’s
common stock for stock options that were in-the-money at period end. As of June 30, 2022, the aggregate intrinsic value for the options
vested and outstanding was $ 622,502 and $ 1,224,607 , respectively. The aggregate intrinsic value of the options exercised during the six months
ended June 30, 2022 was $ 148,982 .
Stock
Warrants
On
January 5, 2022, in connection with the issuance of the over-allotment purchase discussed above, the Company issued warrants for the
purchase of 31,500 shares of the Company’s common stock, with a term of 5 years and an exercise price of $ 6.25 per share which
vest six months after the date of issuance.
12
The
following table summarizes the stock warrant activity for the six months ended June 30, 2022:
Schedule of Stock Warrant Activity
Warrants
Weighted-Average
Exercise Price Per
Share
Outstanding and exercisable, January 1, 2022
366,000
$ 3.93
Granted
31,500
$ 6.25
Exercised
-
$ -
Forfeited
-
$ -
Expired
-
$ -
Outstanding and exercisable, June 30, 2022
397,500
$ 4.11
The
following table discloses information regarding outstanding and exercisable warrants at June 30, 2022:
Schedule of Stock Outstanding and Exercisable
Outstanding
Exercisable
Exercise Price
Number of
Option
Shares
Weighted
Average
Exercise Price
Weighted
Average
Remaining
Life (Years)
Number of
Option
Shares
Weighted
Average
Exercise Price
$ 0.80
156,000
$ 0.80
8.74
156,000
$ 0.80
$ 6.25
241,500
$ 6.25
4.46
210,000
$ 6.25
397,500
$ 4.11
6.14
366,000
$ 3.93
Aggregate
intrinsic value is calculated as the difference between the exercise price of the underlying stock warrant and the fair value of the
Company’s common stock for stock warrants that were in-the-money at period end. As of June 30, 2022, the intrinsic value for the
warrants vested and outstanding was $ 280,800 .
Note
5 – Commitments and Contingencies
Indemnifications
In
the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties
and may provide for indemnification of the counterparty. The Company’s exposure under these agreements is unknown because it involves
claims that may be made against it in the future but have not yet been made. To date, the Company has not been subject to any claims
or been required to defend any action related to its indemnification obligations.
The
Company indemnifies each of its directors and officers for certain events or occurrences, subject to certain limits, while the director
is or was serving at the Company’s request in such capacity, as permitted under Delaware law and in accordance with its certificate
of incorporation and bylaws. The term of the indemnification period lasts as long as the director or officer may be subject to any proceeding
arising out of acts or omissions of such individual in such capacity. The maximum amount of potential future indemnification is unlimited.
The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized
any liabilities relating to these obligations as of June 30, 2022.
Royalty
Agreement
On
December 22, 2014, the Company entered into a Master Service Agreement (“MSA”) with AxioMx, Inc. (“AxioMx”).
AxioMx is in the business of developing and supplying custom affinity reagents. AxioMx and the Company entered into the MSA to serve
as a master agreement governing multiple sets of projects as may be agreed upon by them from time to time. Pursuant to the MSA, AxioMx
is entitled to royalties on the sale of any Deliverable (as defined in the MSA) that is used for diagnostic, prognostic or therapeutic
purposes, in humans or animals, or for microbiology testing, including food safety testing or environmental monitoring. Specifically,
the Company shall pay AxioMx a royalty of 3.5% of Net Sales (as defined in the MSA) of assigned products for each Deliverable used in
licensed products for therapeutic purposes. In addition, the Company shall pay AxioMx a royalty of 1.5% of Net Sales of assigned products
for each Deliverable used in licensed products for diagnostic or prognostic purposes; provided, however, if three Deliverables are used
in an assigned product for diagnostic or prognostic purposes, the royalty shall be 4.5%. Through June 30, 2022, no amounts have been
paid or accrued under the MSA.
13
Legal
Proceedings
From
time to time the Company may be involved in claims that arise during the ordinary course of business. Although the results of litigation
and claims cannot be predicted with certainty, the Company does not currently have any pending litigation to which it is a party or to
which its property is subject that it believes to be material. Regardless of the outcome, litigation can be costly and time consuming,
and it can divert management’s attention from important business matters and initiatives, negatively impacting the Company’s
overall operations.
Employment
Agreements
On
June 18, 2021, the Company entered into an Employment Agreement with Ilya Rachman (the “Rachman Employment Agreement”),
effective for a three-year term. Pursuant to the Rachman Employment Agreement, the Company employs Dr. Rachman as Chief Executive
Officer and Dr. Rachman is entitled to a base salary of $ 360,000 annually.
Dr. Rachman is also entitled to a performance-based bonus of 100 % of
the base salary (subject to, and determined by, the Board in its sole discretion) plus additional performance bonuses to be
determined by the Board. Unless terminated by the Company without “cause” or by Dr. Rachman with “good
reason” (as such terms are defined in the Rachman Employment Agreement), upon termination, Dr. Rachman will be entitled only
to his base salary through the date of termination, valid expense reimbursements and unused vacation pay. If terminated by the
Company without “cause” or by Dr. Rachman with “good reason,” he is entitled to be paid his base salary
through the end of the term at the rate of 150 % ,
valid expense reimbursements and accrued but unused vacation pay. Dr. Rachman’s employment agreement contains provisions for
the protection of our intellectual property and contains non-compete restrictions in the event of his termination other than us
without “cause” or by Dr. Rachman with “good reason” (generally imposing restrictions on (i) employment or
consultation with competing companies or customers, (ii) recruiting or hiring employees for a competing company and (iii) soliciting
or accepting business from our customers for a period of six months following termination). Pursuant to the Rachman Employment
Agreement, Dr. Rachman may serve as a consultant to, or on boards of directors of, or in any other capacity to other companies
provided that they will not interfere with the performance of his duties to us. On July 14, 2022, the Compensation Committee of the
Board of Directors approved a new compensation package for Dr. Rachman which included (i) increasing Dr. Rachman’s annual base
salary to $ 425,000 ,
retroactive as of January 1, 2022, and (ii) entitling him to a performance-based bonus up to 50 % of
his base salary (subject to, and determined by, the Board in its sole discretion) plus additional performance bonuses to be
determined by the Board. The Board also authorized the issuance of options to purchase up to 250,000
shares of the Company’s common stock to Dr. Rachman. As of June 30, 2022, the Company has accrued $ 32,500 of
compensation related to the new compensation package to Dr. Rachman.
On
March 18, 2021, the Company entered into a Management Services Agreement with Alwaysraise LLC, an entity which Gabriel Morris, the
Company’s Chief Financial Officer and a member of the Board, is sole member, effective for a three-year term, which was
amended effective June 18, 2021 (as amended, the “Morris MSA”). Pursuant to the Morris MSA, we employ Mr. Morris as
Chief Financial Officer and Mr. Morris is entitled to a base salary of $ 240,000 annually
beginning in December 2021 ($ 120,000 annually
prior). Mr. Morris is also entitled to a performance-based bonus of 100 % of
the base salary (subject to, and determined by, the Board in its sole discretion) plus additional performance bonuses to be
determined by the Board. Unless terminated by the Company without “cause” or by Alwaysraise LLC (as such terms are
defined in the Morris MSA), upon termination, Mr. Morris will be entitled only to his base salary through the date of termination,
valid expense reimbursements and unused vacation pay. If terminated by the Company without “cause,” he is entitled to be
paid his base salary through the end of the term at the rate of 150 % ,
valid expense reimbursements and accrued but unused vacation pay. The Morris MSA contains provisions for the protection of our
intellectual property and confidential information. On July 14, 2022, the Compensation Committee of the Board of Directors approved
a new compensation package for Mr. Morris which included (i) increasing his annual base salary to $ 425,000 ,
retroactive as of January 1, 2022, and (ii) entitling him to a performance-based bonus up to 50 % of
his base salary (subject to, and determined by, the Board in its sole discretion) plus additional performance bonuses to be
determined by the Board. The Board also authorized the issuance of options to purchase up to 250,000
shares of the Company’s common stock to Mr. Morris. As of June 30, 2022, the Company has accrued $ 92,500 of
compensation related to the new compensation package to Mr. Morris.
On
June 24, 2021, the Company issued an offer letter to Graham Ross Oncology Consulting Services Ltd., a United Kingdom company, of which
Graham Ross, the Company’s consulting Acting Chief Medical Officer and Head of Clinical Development is the sole member, with respect
to Dr. Ross’ consulting services (the “Offer Letter”). Pursuant to the Offer Letter (signed by Dr. Ross on June 24,
2021), Dr. Ross is entitled to an hourly rate for his consulting services and an option grant. On June 24, 2021, the Company also signed
a mutual confidentiality and non-disclosure agreement with Graham Ross Oncology Consulting Services Ltd.
Indemnification
Agreements
In
the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business
partners and other parties with respect to certain matters including, but not limited to, losses arising out of breech of such
agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into
indemnification agreements with officers and members of its Board of Directors that will require the Company, among other things, to
indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum
potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases,
unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. At June 30, 2022, no
claims exist under indemnification arrangements and accordingly, no amounts have been accrued in the Company’s condensed
consolidated financial statements as of June 30, 2022.
Collaboration
Agreement
In
August 2021, the Company signed a Clinical Collaboration and Supply Agreement with BeiGene Ltd. (“BeiGene”) for a combination
Phase 1b clinical trial in solid tumors of IMX-110 and anti-PD-1 Tislelizumab (the subject of a collaboration and license agreement among
BeiGene and Novartis). Under the terms of the agreement, the Company will conduct the combination trial. The cost of tislelizumab manufacture
and supply (including shipping, taxes and duty if applicable and any third-party license payments that may be due) will be solely borne
by BeiGene.
Note
6 – Subsequent Events
Subsequent
events have been evaluated subsequent to the consolidated balance sheet date of June 30, 2022 through the filing date of this Quarterly
Report. Based on management’s evaluation, there are no other events that required recognition or disclosure, other than those discussed
below and elsewhere in the notes hereto.
On
July 14, 2022, the Compensation Committee of the Board of Directors approved a new compensation package for Dr. Rachman and Mr.
Morris which included (i) increasing the annual base salary to $ 425,000
for each executive, retroactive as of January 1, 2022, and (ii) entitling each executive to a performance-based bonus equal to up to 50 %
of such executive’s base salary (subject to, and determined by, the Board in its sole discretion) plus additional performance bonuses to be
determined by the Board. The Board also authorized the issuance of options to purchase up to 250,000
shares of the Company’s common stock to each of Dr. Rachman and Mr. Morris (see Note 5).
On
July 14, 2022, the Compensation Committee of the Board of Directors approved a new compensation package for non-employee members of
the Board of Directors and its related committees, retroactive as of January 1, 2022. Pursuant to such new compensation package,
each Board member will receive $ 40,000
annually. In addition, members of the Audit Committee will receive $ 7,500
annually, with the chair of the Audit Committee receiving an additional $ 10,000
annually; members of the Compensation Committee will receive $ 5,000
annually, with the chair of the Compensation Committee receiving an additional $ 5,000
annually; and members of the Nominating and Corporate Governance Committee will receive $ 4,000
annually, with the chair of the Nominating and Corporate Governance Committee receiving an additional $ 4,000
annually.
14
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
You
should read the following discussion and analysis of our financial condition and results of operations together with our unaudited
interim condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q.
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 those discussed below. Factors that could cause or
contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled
“Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as may be
amended, supplemented or superseded from time to time by other reports we file with the SEC. All amounts in this report are in U.S.
dollars, unless otherwise noted.
Throughout
this Quarterly Report on Form 10-Q, references to “we,” “our,” “us,” the “Company,” “Immix,”
or “Immix Biopharma” refer to Immix Biopharma, Inc., individually, or as the context requires, collectively with its subsidiary.
Overview
We
are a clinical-stage pharmaceutical company focused on the development of safe and effective therapies for patients with cancer and inflammatory
diseases. In August 2016, we established a wholly-owned Australian subsidiary, Immix Biopharma Australia Pty Ltd., in order to conduct
various pre-clinical and clinical activities for the development of our product candidates.
Since
inception, we have devoted substantially all of our resources to developing product and technology rights, conducting research and development,
organizing and staffing our Company, business planning and raising capital. We operate as one business segment and have incurred recurring
losses, the majority of which are attributable to research and development activities and negative cash flows from operations. We have
funded our operations primarily through the sale of convertible debt and sale of common stock through our initial public offering (“IPO”).
Currently, our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and
to a lesser extent, general and administrative expenditures. We expect to continue to incur significant expenses and operating losses
for the foreseeable future as we advance our product candidates through all stages of development and clinical trials and, ultimately,
seek regulatory approval. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant
commercialization expenses related to product manufacturing, marketing, sales and distribution. Furthermore, we incur costs associated
with operating as a public company, including significant legal, accounting, investor relations and other expenses. Our net losses may
fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenses on
other research and development activities.
AxioMx
Master Services Agreement
On
December 22, 2014, we entered into a Master Service Agreement (“MSA”) with AxioMx, Inc. (“AxioMx”) which is in
the business of developing and supplying custom affinity reagents. We entered into the MSA to serve as a master agreement governing multiple
sets of projects as may be agreed upon us and AxioMx from time to time. Pursuant to the MSA, we granted AxioMx a non-exclusive, royalty-free,
worldwide, non-transferable license to certain of our intellectual property to perform services pursuant to the MSA, and AxioMx granted
us an exclusive product assignment option (“Option”) which granted us an exclusive, royalty-bearing right, with the right
to sublicense, under the Deliverable (as defined in the MSA) to further research, develop, use, sell, offer for sale, import and export
one or more assigned products pursuant to the MSA. We exercised the Option in 2017. Pursuant to the MSA, AxioMx is entitled to royalties
on the sale of any Deliverable that is used for diagnostic, prognostic or therapeutic purposes, in humans or animals, or for microbiology
testing, including food safety testing or environmental monitoring. Specifically, we shall pay AxioMx a royalty of 3.5% of Net Sales
(as defined in the MSA) of assigned products for each Deliverable used in licensed products for therapeutic purposes. In addition, we
shall pay AxioMx a royalty of 1.5% of Net Sales of assigned products for each Deliverable used in licensed products for diagnostic or
prognostic purposes; provided, however, if three Deliverables are used in an assigned product for diagnostic or prognostic purposes,
the royalty shall be 4.5%. Subject to certain exceptions, the MSA shall continue for a period of five years from the effective date,
unless extended by us and AxioMx. The MSA may be terminated by either party upon a material breach of the MSA, which breach remains uncured
for 30 days after written notice thereof. In addition, we may also terminate the MSA at any time upon 30 days prior written notice to
AxioMx. As of June 30, 2022, the MSA has not been amended or extended however, the royalty obligations described in this paragraph survive
the termination of the MSA.
The
COVID-19 Pandemic and its Impacts on Our Business
In
March 2020, the World Health Organization declared the outbreak of COVID-19 a global pandemic. This pandemic could result in difficulty
securing clinical trial site locations, contract research organizations, and/or trial monitors and other critical vendors and consultants
supporting our trial. These situations, or others associated with COVID-19, could cause delays in our clinical trial plans and could
increase expected costs, all of which could have a material adverse effect on our business and financial condition. At the current time,
we are unable to quantify the potential effects of this pandemic on our future consolidated financial statements.
15
Results
of Operations
Three
Months Ended June 30, 2022 compared to the Three Months Ended June 30, 2021
General
and Administrative Expense
General
and administrative expense was $953,203 for the three months ended June 30, 2022, compared to $180,404 in the three months ended June
30, 2021.
The
expenses incurred in both periods were related to salaries, patent maintenance costs and general accounting and other general consulting
expenses, which were higher for the three months ended June 30, 2022, due to increased professional services, officer salaries and stock-based
compensation as a result of the IPO closing.
Research
and Development Expense
Research
and development expense was $607,751 for the three months ended June 30, 2022, compared to $62,761 for the three months ended June 30,
2021.
The
increased research and development expenses during the three months ended June 30, 2022, as compared to the three months ended June 30,
2021, were related to our ongoing Phase 1b/2a clinical trial, including, but not limited to, contract research organization (“CRO”)
and related costs for maintaining and treating patients in the clinical trial. We were able to increase spending on research and development
as a result of closing the IPO in December 2021. We expect to incur increased research and development costs in the future as our
product development activities expand.
Interest
Expense
Interest
expense was $109 for the three months ended June 30, 2022, compared to $53,865 for the three months ended June 30, 2021. Interest expense
in the prior period was related to interest accrued on our convertible notes payable bearing interest at rates from the applicable federal
rate to 6% per annum, which were converted to shares of our common stock in connection with our IPO in December 2021.
Change
in fair value of derivative liability
The
change in fair value of derivative liability was $0 for the three months ended June 30, 2022, compared to a gain of $90,000 for the
three months ended June 30, 2021. The change in fair value during the three months ended June 30, 2021 was related to an increased
probability of a “Qualified Financing” as defined in our convertible notes at June 30, 2021.
Provision
for Income Taxes
Provision
for income taxes for the three months ended June 30, 2022 was $1,715 compared to $1,608 for the three months ended June 30, 2021, due
to withholding taxes relating to our Australian subsidiary.
Net
Loss
Net
loss for the three months ended June 30, 2022 was $1,562,778 compared to $208,638 for the three months ended June 30, 2021, which increase
was due primarily to the increase in general and administrative expenses and research and development, offset by the change in fair value
of derivative liability.
Six
Months Ended June 30, 2022 compared to the Six Months Ended June 30, 2021
General
and Administrative Expense
General
and administrative expense was $1,653,710 for the six months ended June 30, 2022 compared to $318,084 for the six months ended June 30,
2021.
The
expenses incurred in both periods were related to salaries, patent maintenance costs and general accounting and other general consulting
expenses, which were higher for the six months ended June 30, 2022, due to increased professional services, officer salaries and stock-based
compensation as a result of the IPO closing.
Research
and Development Expense
Research
and development expense was $1,237,282 for the six months ended June 30, 2022 compared to $87,601 for the six months ended June 30, 2021.
16
The
increased research and development expenses during the six months ended June 30, 2022, as compared to the six months ended June 30, 2021,
were related to our ongoing Phase 1b/2a clinical trial, including, but not limited to, CRO and related costs for maintaining and treating
patients in the clinical trial. We were able to increase spending on research and development as the result of closing the IPO in December
2021. We expect to incur increased research and development costs in the future as our product development activities expand.
Interest
Expense
Interest
expense was $497 for the six months ended June 30, 2022 compared to $81,409 for the six months ended June 30, 2021. Interest expense
in the prior period was related to interest accrued on our convertible notes payable bearing interest at rates from the applicable federal
rate to 6% per annum, which were converted to shares of our common stock in connection with our IPO in December 2021.
Change
in fair value of derivative liability
The
change in fair value of derivative liability was $0 for the six months ended June 30, 2022 compared to a loss of $735,000 for the
six months ended June 30, 2021. The change in fair value during the six months ended June 30, 2021 was related to an increased
probability of a “Qualified Financing” as defined in our convertible notes at June 30, 2021.
Provision
for Income Taxes
Provision
for income taxes for the six months ended June 30, 2022 was $3,337 compared to $3,199 for the six months ended June 30, 2021, due to
withholding taxes relating to our Australian subsidiary.
Net
Loss
Net
loss for the six months ended June 30, 2022 was $2,894,826 compared to $1,225,293 for the six months ended June 30, 2021, which increase
was due primarily to the increase in general and administrative expenses and research and development, offset by the change in fair value
of derivative liability.
Liquidity
and Capital Resources
Our
primary use of cash is to fund operating expenses, which consist of research and development expenditures and various 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, accrued expenses and prepaid expenses.
Because
of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are
unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors,
including, but not limited to:
●
the
scope, timing, progress and results of discovery, pre-clinical development, laboratory testing and clinical trials for our product
candidates;
●
the
costs of manufacturing our product candidates for clinical trials and in preparation for regulatory approval and commercialization;
●
the
extent to which we enter into collaborations or other arrangements with additional third parties in order to further develop our
product candidates;
●
the
costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending
intellectual property-related claims;
●
the
costs and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies;
●
expenses
needed to attract and retain skilled personnel;
●
the
costs associated with being a public company;
●
the
costs required to scale up our clinical, regulatory and manufacturing capabilities;
●
the
costs of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities,
for any of our product candidates for which we receive regulatory approval; and
●
revenue,
if any, received from commercial sales of our product candidates, should any of our product candidates receive regulatory approval.
17
We
will need additional funds to meet our operational needs and capital requirements for clinical trials, other research and development
expenditures, and general and administrative expenses. We currently have no credit facility or committed sources of capital.
Until
such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity
offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other
collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity
or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or
other preferences that adversely affect your rights as a common stockholder. If we raise additional funds through collaborations, strategic
alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies,
future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are
unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit,
reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product
candidates that we would otherwise prefer to develop and market ourselves.
Cash
used in operating activities
Net
cash used in operating activities was $2,041,888 for the six months ended June 30, 2022 and $424,454 for the six months ended June 30,
2021 and primarily included general and administrative, CRO, clinical site costs and related logistics expenses.
Cash
used in investing activities
Net
cash used in investing activities was $0 for the six months ended June 30, 2022 and $802 for the six months ended June 30, 2021. Net
cash used in investing activities for the six months ended June 30, 2021 was related to the purchase of equipment.
Cash
provided by financing activities
Net
cash provided by financing activities was $2,807,787 for the six months ended June 30, 2022 and $147,327 for the six months ended June
30, 2021. We received $2,913,750 in net proceeds from the issuance of shares of our common stock pursuant to the exercise of the underwriter’s
overallotment option to purchase additional shares of our common stock in connection with our IPO completed in December 2021.
Our
continuation as a going concern is dependent upon our ability to obtain necessary financing to continue operations and the attainment
of profitable operations. As of June 30, 2022, we have incurred an accumulated deficit of $32,650,360 and have not yet generated any
revenue from operations. Management anticipates that our cash on hand will be sufficient to fund planned operations for at least 12 months
from the filing date of this Quarterly Report on Form 10-Q.
We
will have additional capital requirements going forward and may need to seek additional financing, which may or may not be available
to us on acceptable terms, if at all.
JOBS
Act
On
April 5, 2012, the Jumpstart Our Business Startups Act (the “JOBS Act”) was enacted. Section 107 of the JOBS Act provides
that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of
the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can
delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
We
have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying
with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act.
As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for
complying with new or revised accounting standards.
Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,
including, without limitation, (i) providing an auditor’s attestation report on our internal controls over financial reporting
pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended, and (ii) complying with the requirement adopted by the Public
Company Accounting Oversight Board (“PCAOB”) regarding the communication of critical audit matters in the auditor’s
report on financial statements. We will remain an “emerging growth company” until the earliest of (i) the last day of the
fiscal year in which we have total annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the
fifth anniversary of the date of the completion of our initial public offering; (iii) the date on which we have issued more than $1 billion
in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under
the rules of the SEC.
18
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We
are not required to provide the information required by this Item as we are a “smaller reporting company,” as defined in
Rule 12b-2 of the Exchange Act.
ITEM
4. CONTROLS AND PROCEDURES.
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of
our “disclosure controls and procedures” (as defined in Exchange Act Rules 13a-15I and 15d-15(e)) as of June 30, 2022, the
end of the period covered by this Quarterly Report on Form 10-Q. The term “disclosure controls and procedures” as defined
in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure
that information required to be disclosed by a company in the reports that it files 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 under the Exchange Act is accumulated and communicated to a company’s management, including its principal executive officer
and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating
the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated,
cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute
assurance that all control issues and instances of fraud, if any, within a company have been detected. Based on the evaluation of our
disclosure controls and procedures as of June 30, 2022, our management, with the participation of our principal executive officer and
principal financial officer has concluded that, based on such evaluation, as of the end of the period covered by this Quarterly Report
on Form 10-Q, our disclosure controls and procedures were not effective due to the material weakness described below. However, our management,
including our principal executive officer and principal financial officer, has concluded that, notwithstanding the identified material
weakness in our internal control over financial reporting, the financial statements in this Quarterly Report on Form 10-Q fairly present,
in all material respects, our financial condition, results of operations and cash flows for the periods presented in conformity with
U.S. GAAP.
Material
Weakness in Internal Controls Over Financial Reporting
We
identified a material weakness in our internal control over financial reporting that exists as of June 30, 2022. A material weakness
is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility
that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. We determined
that we had a material weakness because, due to our small size, and our limited number of personnel, we did not have in place an effective
internal control environment with formal processes and procedures, including journal entry processing and review, to allow for a detailed
review of accounting transactions that would identify errors in a timely manner.
Notwithstanding
the material weaknesses in our internal control over financial reporting, we have concluded that the condensed consolidated
financial statements included in this Quarterly Report on Form 10-Q fairly present, in all material respects, our financial
position, results of operations and cash flows for the periods presented in conformity with GAAP.
Management’s
Plan to Remediate the Material Weakness
With
the oversight of senior management, we implemented remediation steps in 2021 including addition of accounting consultants and continue
to evaluate and implement procedures that will strengthen our internal controls. While we believe these measures will remediate the material
weakness identified and strengthen our internal control over financial reporting, the implemented and enhanced controls have not operated
for a sufficient period of time to demonstrate that the material weakness is remediated. We are committed to continuing to improve our
internal control processes and will continue to diligently review our financial reporting controls and procedures.
Changes
in Internal Control
There
have been no changes in our internal control over financial reporting that occurred during our last fiscal quarter that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II — OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS.
From
time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation
is subject to inherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm our business.
We are currently not aware of any such legal proceedings or claims that will have, individually or in the aggregate, a material adverse
effect on our business, financial condition or operating results.
ITEM
1A. RISK FACTORS.
Risk
factors that affect our business and financial results are discussed in Part I, Item 1A “Risk Factors,” in our Annual
Report on Form 10-K for the year ended December 31, 2021 (“Annual Report”) as filed with the SEC on March 28, 2022.
There have been no material changes in our risk factors from those previously disclosed in our Annual Report. You should carefully
consider the risks described in our Annual Report, which could materially affect our business, financial condition or future
results. The risks described in our Annual Report are not the only risks we face. Additional risks and uncertainties not currently
known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition,
and/or operating results. If any of the risks actually occur, our business, financial condition, and/or results of operations could
be negatively affected.
19
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
Issuances of Unregistered Securities
On
May 14, 2022, we issued 26,315 shares of our common stock for services in the amount of $50,000.
On
June 2, 2022, we issued 62,532 shares of our common stock upon the cashless exercise of 140,992 stock options.
The
foregoing issuances were exempt from registration under Section 4(a)(2) of the Securities Act.
Issuer
Purchases of Equity Securities
The following table provides
information about our purchases of equity securities during the quarter ended June 30, 2022. During the quarter ended June 30, 2022, we
repurchased 37,418 shares of our common stock at a cost of $55,963 and $944,037 remains authorized for share repurchase. We
have used available cash to finance these repurchases.
Period
Total Number of
Shares Purchased
Average Price
Paid per Share (1)
Total Number of
Shares Purchased as
Part of Publicly
Announced Plans or
Programs
(2)
Approximate
Dollar Value of Shares
that May Yet Be
Purchased Under the
Plans or Programs
(in thousands)
4/1/2022 - 4/30/2022
-
$ -
-
$ 1,000,000
5/1/2022 - 5/31/2022
37,418
$ 1.53
37,418
$ 944,037
6/1/2022 - 6/30/2022
-
$ -
-
$ 944,037
Total
37,418
$ 1.53
37,418
$ 944,037
(1)
The average price paid per share and approximate dollar value of shares that may yet be purchased
under the share repurchase program exclude fees, commissions, and other charges for the related transactions.
(2)
On April 29, 2022, our board of directors authorized the repurchase of
up to $1,000,000 shares of our common stock. Under this program, we can repurchase shares of our
common stock in the open market or through privately-negotiated transactions. The share repurchase plan became effective on April 29,
2022 and is scheduled to continue through the earlier of its expiration on December 31, 2022, or the completion of repurchases up to the
approved amount. Pursuant to the program, on May 9,
2022, we entered into a Repurchase Agreement (the “Initial Repurchase Agreement”) with a financial institution pursuant
to which such financial institution could purchase shares of our common stock upon the terms and conditions set forth in such agreement,
including in accordance with the guidelines specified in Rules 10b5-1 and 10b-8 under the Exchange
Act. The Initial Repurchase Agreement terminated on May 31, 2022, upon the expiration of the agreement. We will determine the timing and amount of any additional repurchases based on our evaluation of market conditions,
applicable SEC guidelines and regulations, and other factors. This program may be suspended or discontinued at any time at the discretion
of our board of directors.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM
4. MINE SAFETY DISCLOSURES.
Not
applicable.
ITEM
5. OTHER INFORMATION.
None.
ITEM
6. EXHIBITS.
Exhibit
No.
Description
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1**
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes- Oxley Act of 2002
32.2**
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes- Oxley Act of 2002
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 - the cover page from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2022 is formatted in Inline XBRL
*
Filed
herewith.
**
Furnished herewith.
20
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.
IMMIX
BIOPHARMA, INC.
Date:
August 12, 2022
By:
/s/
Ilya Rachman
Ilya
Rachman
Chief
Executive Officer
(Principal
Executive Officer)
Date:
August 12, 2022
By:
/s/
Gabriel Morris
Gabriel
Morris,
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
21
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.