The Company has not generated any revenues and has incurred significant losses
since inception. For the nine months ended September 30, 2022, the Company used
cash in operations of $9,200,830. As of September 30, 2022, the Company has an
accumulated deficit of $85,666,267 and working capital of $1,789,844. On July
17, 2022, the Company entered into a Securities Purchase Agreement with certain
purchasers, pursuant to which the Company agreed to sell an aggregate of
3,500,000 shares of common stock, pre-funded warrants to purchase up to an
aggregate of 2,632,076 shares of common stock ("July 2022 Pre-Funded Warrants"),
and common stock warrants to purchase up to an aggregate of 6,132,076 shares of
common stock (the "July 2022 Common Warrants"), at a combined purchase price of
$1.06 per share and warrant (the "July 2022 Offering"). Aggregate gross proceeds
from the July 2022 Offering were $6,499,737 (see Note 9 - Stockholder's Equity).
The July 2022 Offering closed on July 20, 2022.



On March 11, 2020, the World Health Organization declared COVID-19 a pandemic.
The extent of COVID-19's effect on the Company's operational and financial
performance will depend on future developments, including the duration, spread
and intensity of the pandemic (including any resurgences), the impact of
variants of the virus that causes COVID-19, labor needs at the Company as well
as in the supply chain, compliance with government or employer COVID-19 vaccine
mandates and the resulting impact on available labor, and the level of social
and economic restrictions imposed in the United States and abroad in an effort
to curb the spread of the virus, all of which are uncertain and difficult to
predict.



                                       7





Management has evaluated, and will continue to evaluate, the impact of the
COVID-19 pandemic on the industry and has concluded that while it is reasonably
possible that the virus could have a negative effect on the Company's financial
position or results of its operations, the specific impact is not readily
determinable as of the date of these unaudited condensed consolidated financial
statements (the "condensed consolidated financial statements"). The follow-up
time for patient data and the statistical analysis for the Phase 2b Dupuytren's
Contracture clinical trial was delayed as a result of COVID-19, but such
follow-up and statistical analyses are now complete. The Company announced the
top-line data results from the Phase 2b trial on December 1, 2021 and the data
was published on April 29, 2022 in a peer-reviewed journal. The Company may
experience similar delays in other clinical trials due to the continued future
impact of COVID-19. The condensed consolidated financial statements do not
include any adjustments that might result from the outcome of this uncertainty.



These condensed consolidated financial statements have been prepared under the
assumption of a going concern, which assumes that the Company will be able to
realize its assets and discharge its liabilities in the normal course of
business. The Company's ability to continue its operations is dependent upon
obtaining new financing for its ongoing operations. Future financing options
available to the Company include equity financings and loans and if the Company
is unable to obtain such additional financing timely, or on favorable terms, the
Company may have to curtail its development, marketing and promotional
activities, which would have a material adverse effect on its business,
financial condition and results of operations, and it could ultimately be forced
to discontinue its operations and liquidate. These matters raise substantial
doubt about the Company's ability to continue as a going concern for a
reasonable period of time, which is defined as within one year after the date
that the condensed consolidated financial statements are issued. Realization of
the Company's assets may be substantially different from the carrying amounts
presented in these condensed consolidated financial statements and the
accompanying condensed consolidated financial statements do not include any
adjustments that may become necessary, should the Company be unable to continue
as a going concern.


NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Significant Accounting Policies


There have been no material changes to the Company's significant accounting
policies as set forth in the Company's audited consolidated financial statements
included in the Annual Report on Form 10-K for the year ended December 31, 2021
under Note 3 - Summary of Significant Accounting Policies, except as disclosed
in this note.



Basis of Presentation



The accompanying unaudited condensed consolidated financial statements of the
Company have been prepared on a going concern basis in accordance with
accounting principles generally accepted in the United States of America (GAAP)
for interim financial reporting and as required by
Regulation S-X, Rule 10-01. Accordingly, they do not include all of the
information and footnotes required by GAAP for complete financial statements. In
the opinion of management, all adjustments (including those which are normal and
recurring) considered necessary for a fair presentation of the interim financial
information have been included. When preparing financial statements in
conformity with GAAP, the Company must make estimates and assumptions that
affect the reported amounts of assets, liabilities, revenues, expenses and
related disclosures at the date of the financial statements. Actual results
could differ from those estimates. Additionally, operating results for the three
and nine months ended September 30, 2022, are not necessarily indicative of the
results that may be expected for any other interim period or for the fiscal year
ending December 31, 2022. For further information, refer to the financial
statements and footnotes included in the Company's annual financial statements
for the fiscal year ended December 31, 2021, which are included in the Company's
annual report on Form 10-K filed with the Securities and Exchange Commission
("SEC") on March 31, 2022.



Use of Estimates



The preparation of financial statements in conformity with U.S. GAAP requires
management to make estimates, judgments, and assumptions that affect the
reported amounts of assets, liabilities, revenues and expenses, together with
amounts disclosed in the related notes to the condensed consolidated financial
statements. The Company's significant estimates and assumptions used in these
condensed consolidated financial statements include, but are not limited to, the
collectability of an insurance claims receivable, the fair value of financial
instruments warrants, options and equity shares, the valuation of stock-based
compensation, and the estimates and assumptions related to impairment analysis
of goodwill and other intangible assets.



Certain of the Company's estimates could be affected by external conditions,
including those unique to the Company and general economic conditions. It is
reasonably possible that these external factors could have an effect on the
Company's estimates and may cause actual results to differ from those estimates.



                                       8





Foreign Currency Translation



The Company's reporting currency is the United States dollar. The functional
currency of certain subsidiaries was the Canadian Dollar ("CAD") (0.7874 CAD to
1 US dollar as of December 31, 2021) or British Pound ("GBP") (1.1150 and 1.3510
GBP to 1 US dollar, each as of September 30, 2022 and December 31, 2021,
respectively), while expense accounts are translated at the weighted average
exchange rate for the period (0.7941 CAD and 0.7992 CAD to 1 US dollar for each
of the three and nine months ended September 30, 2021, respectively, 1.1772 and
1.3784 GBP to 1 US dollar for each of the three months ended September 30, 2022
and 2021, respectively, and 1.2597 and 1.3847 GBP to 1 US dollar for each of the
nine months ended September 30, 2022 and 2021, respectively). Equity accounts
are translated at historical exchange rates. The resulting translation
adjustments are recognized in stockholders' equity as a component of accumulated
other comprehensive income.



Comprehensive income (loss) is defined as the change in equity of an entity from
all sources other than investments by owners or distributions to owners and
includes foreign currency translation adjustments as described above. During the
three months ended September 30, 2022 and 2021, the Company recorded other
comprehensive loss of ($1,871,072) and ($530,817), respectively, as a result of
foreign currency translation adjustments. During the nine months ended September
30, 2022 and 2021, the Company recorded other comprehensive (loss) income of
($4,507,204) and $65,018, respectively, as a result of foreign currency
translation adjustments.



Foreign currency gains and losses resulting from transactions denominated in
foreign currencies, including intercompany transactions, are included in results
of operations. The Company recognized ($14,031) and ($14,151) of foreign
currency transaction losses for the three and nine months ended September 30,
2022, respectively, and recognized ($218,834) and ($200,264) of foreign currency
transaction losses for the three and nine months ended September 30, 2021,
respectively. Such amounts have been classified within general and
administrative expenses in the accompanying condensed consolidated statements of
operations and comprehensive income (loss).



Impairment of Long-Lived Assets and Goodwill





The Company reviews long-lived assets and certain identifiable assets for
impairment whenever circumstances and situations change such that there is an
indication that the carrying amounts may not be recovered. An impairment exists
when the carrying value of the long-lived asset is not recoverable and exceeds
its estimated fair value.


Goodwill represents the difference between the purchase price and the fair value
of assets and liabilities acquired in a business combination. The Company
reviews goodwill yearly, or more frequently whenever circumstances and
situations change such that there is an indication that the carrying amounts may
not be recovered, for impairment by initially considering qualitative factors to
determine whether it is more likely than not that the fair value of a reporting
unit is less than its carrying amount, including goodwill, as a basis for
determining whether it is necessary to perform a quantitative analysis. If it is
determined that it is more likely than not that the fair value of reporting unit
is less than its carrying amount, a quantitative analysis is performed to
identify goodwill impairment. If it is determined that it is not more likely
than not that the fair value of the reporting unit is less than its carrying
amount, it is unnecessary to perform a quantitative analysis. The Company may
elect to bypass the qualitative assessment and proceed directly to performing a
quantitative analysis. As of December 31, 2021, the Company elected to bypass
the qualitative assessment and conducted a quantitative assessment whereby it
was determined the fair value of the reporting unit (which the Company concluded
was the consolidated entity), exceeded the carrying value and, accordingly,
there was no impairment of goodwill.



During the quarter, the market value of the Company's single reporting unit had
significantly declined and as such, the Company elected to conduct a
quantitative analysis of goodwill to assess for impairment. As of September 30,
2022, the market value of the Company's publicly traded stock was $0.67 per
share; the Company determined the fair market value of its single reporting unit
as of that date to be $26,102,105, which represents the value per share
multiplied by 39,251,286 shares (consisting of 39,246,011 shares of common stock
outstanding as of September 30, 2022 plus 5,275 special voting shares which are
exchangeable into common stock for no additional consideration). The carrying
amount of the reporting unit as of September 30, 2022 was $44,974,955 (total
assets of $53.2 million less total liabilities of $8.2 million). As of this
measurement date, the carrying value exceeded the fair market value by
$18,872,850 and as such, management determined that the goodwill of the
reporting unit was impaired by this amount. To recognize the impairment of
goodwill, the Company recorded a loss (which appears as an expense on the income
statement) for $18,872,850, which reduced the goodwill of its CannBioRex
Pharmaceuticals Corp. ("CBR") and 180 Therapeutics LP ("180T") subsidiaries by
$11,264,612 and $7,608,238, respectively.



                                       9




The following is a summary of goodwill activity for the nine months ended September 30, 2022 for the Company's single reporting unit, which includes the recorded loss on goodwill impairment described above.





                                                                                            Consolidated
                                                     CBR Goodwill       180T Goodwill         Goodwill

Balance, December 31, 2021                           $  23,749,631     $    13,238,255     $   36,987,886
Currency translation                                      (664,353 )                -            (664,353 )

Balance, March 31, 2022                                 23,085,278          13,238,255         36,323,533
Currency translation                                    (1,734,582 )       

- (1,734,582 )


Balance, June 30, 2022                                  21,350,696          13,238,255         34,588,951
Currency translation                                    (1,750,386 )                -          (1,750,386 )
Balance before impairment                               19,600,310          13,238,255         32,838,565
Impairment of goodwill                                 (11,264,612 )       

(7,608,238 ) (18,872,850 )


Balance, September 30, 2022                          $   8,335,698     $   

 5,630,017     $   13,965,715




The Company will continue to perform goodwill/intangible assets and In-Process
Research and Development ("IPR&D") assets impairment testing on an annual basis,
or as needed if there are changes to the composition of its reporting unit. As
of September 30, 2022, there have been no changes to the composition of the
reporting unit.



Net Income (Loss) Per Common Share


Basic net income (loss) per common share is computed by dividing net income
(loss) by the weighted average number of common shares outstanding during the
period. Diluted net income (loss) per common share is computed by dividing net
income (loss) by the weighted average number of common shares outstanding, plus
the number of additional common shares that would have been outstanding if the
common share equivalents had been issued (computed using the treasury stock or
if converted method), if dilutive.



The following table details the net income (loss) per share calculation,
reconciles between basic and diluted weighted average shares outstanding, and
presents the potentially dilutive shares that are excluded from the calculation
of the weighted average diluted common shares outstanding, because their
inclusion would have been anti-dilutive:



                                              For the Three Months Ended            For the Nine Months Ended
                                                    September 30,                         September 30,
                                               2022                2021             2022                2021
Numerator:
Net (loss) income                          $ (21,486,978 )     $ 18,296,856     $ (16,983,981 )     $ (21,360,865 )
Less: decrease in fair value of dilutive
warrants                                               -         10,487,783                 -                   -
(Loss) income available to common
stockholders - diluted                     $ (21,486,978 )     $  7,809,073

$ (16,983,981 ) $ (21,360,865 )



Weighted average shares outstanding
(denominator for basic earnings per
share)                                        39,181,736 (1)     32,727,965

35,803,504 (1) 30,491,082



Effects of dilutive securities:
Assumed exercise of stock options,
treasury stock method                                  -            182,727                 -                   -
Assumed exercise of warrants, treasury
stock method                                           -            798,892                 -                   -
Dilutive potential common shares                       -            981,619                 -                   -

Weighted average shares and assumed
potential common shares (denominator for
diluted earnings per share, treasury
method)                                       39,181,736 (1)     33,709,584

35,803,504 (1) 30,491,082



Basic earnings per share                   $       (0.55 )     $       0.56     $       (0.47 )     $       (0.70 )
Diluted earnings per share                 $       (0.55 )     $       0.23     $       (0.47 )     $       (0.70 )

(1) This amount includes 1,085,000 of unexercised, pre-funded penny warrants.






                                       10




The following common share equivalents are excluded from the calculation of weighted average common shares outstanding, because their inclusion would have been anti-dilutive:





                                             For the Three Months Ended           For the Nine Months Ended
                                                    September 30,                       September 30,
                                               2022               2021             2022               2021
Options                                        3,259,121           436,000        3,259,121          2,066,000
Warrants                                      17,285,984 (1)     8,526,250       17,285,984 (1)     11,153,908

Total potentially dilutive shares             20,545,105         8,962,250 

     20,545,105         13,219,908



(1) This amount excludes 1,085,000 of unexercised, pre-funded warrants, which are


     not considered to be anti-dilutive, as they are penny warrants.



Warrant, Option and Convertible Instrument Valuation





The Company has computed the fair value of warrants and options using a
Black-Scholes model. The expected term used for warrants is the contractual life
and the expected term used for options issued is the estimated period of time
that options granted are expected to be outstanding. The Company utilizes the
"simplified" method to develop an estimate of the expected term of "plain
vanilla" option grants. The Company is utilizing an expected volatility figure
based on a review of the historical volatilities, over a period of time,
equivalent to the expected life of the instrument being valued, of similarly
positioned public companies within its industry. The risk-free interest rate was
determined from the implied yields from U.S. Treasury zero-coupon bonds with a
remaining term consistent with the expected term of the instrument being valued.



Subsequent Events



The Company has evaluated events that have occurred after the balance sheet date
but before these condensed consolidated financial statements were issued. Based
upon that evaluation, the Company did not identify any recognized or
non-recognized subsequent events that would have required adjustment or
disclosure in the financial statements, except as disclosed in Note 11 -
Subsequent Events.



Recently Issued Accounting Pronouncements





Management does not believe that any recently issued, but not yet effective,
accounting pronouncements, if currently adopted, would have a material effect on
the Company's unaudited condensed consolidated financial statements.



                                       11




NOTE 4 - PREPAID EXPENSES AND OTHER CURRENT ASSETS





Prepaid expenses consist of the following as of September 30, 2022 and December
31, 2021:



                                                                September 30,       December 31,
                                                                    2022                2021
Insurance                                                      $       378,009     $    2,151,487
Research and development expense tax credit receivable                 601,265            644,513
Insurance claims receivable (1)                                      1,836,940                  -
Professional fees                                                       38,311             80,783
Value-added tax receivable                                              46,059             24,411
Taxes                                                                   25,618             25,634
Other                                                                        -             49,755
                                                               $     2,926,202     $    2,976,583

(1) See Note 8 - Commitments and Contingencies - Legal Matters.






NOTE 5 - ACCRUED EXPENSES



Accrued expenses consist of the following as of September 30, 2022 and December
31, 2021:



                                      September 30,       December 31,
                                          2022                2021
Consulting fees                      $       402,315     $      548,281
Professional fees                             26,738            252,973
Accrued legal fees (1)                       218,217            300,000
Employee and director compensation         1,236,014            725,569
Research and development fees                168,172             91,737
Interest                                      33,523             25,433
Other                                          7,050             20,587
                                     $     2,092,029     $    1,964,580

(1) See Note 8 - Commitments and Contingencies, Legal Matters.

As of September 30, 2022 and December 31, 2021, accrued expenses - related parties were $158,467 and $18,370, respectively. See Note 10 - Related Parties for details.





                                       12




NOTE 6 - DERIVATIVE LIABILITIES





The following table sets forth a summary of the changes in the fair value of
Level 3 derivative liabilities (except the Public SPAC Warrants as defined
below, which are Level 1 derivative liabilities) that are measured at fair value
on a recurring basis:



                                                           Warrants
                                     Public         Private
                                      SPAC            SPAC            PIPE           Other          Total
Balance as of January 1, 2022     $  8,048,850     $  467,325     $  6,516,300     $ 187,892     $ 15,220,367
Change in fair value of
derivative liabilities              (1,852,650 )     (251,250 )     (3,044,800 )     (81,414 )     (5,230,114 )
Balance as of March 31, 2022         6,196,200        216,075        3,471,500       106,478        9,990,253
Change in fair value of
derivative liabilities              (4,357,350 )     (185,925 )     (2,849,900 )     (94,363 )     (7,487,538 )
Balance as of June 30, 2022          1,838,850         30,150          621,600        12,115        2,502,715
Change in fair value of
derivative liabilities              (1,246,600 )      (10,050 )       (188,000 )      (5,258 )     (1,449,908 )
Balance as of September 30,
2022                              $    592,250     $   20,100     $    433,600     $   6,857     $  1,052,807

The fair value of the derivative liabilities as of September 30, 2022 and December 31, 2021 was estimated using the Black Scholes option pricing model, with the following assumptions used:





                           September 30,
                                2022
Risk-free interest rate       4.16% - 4.24 %
Expected term in years         1.84 - 3.40
Expected volatility         76.00% - 95.00 %
Expected dividends                       0 %
Market Price              $           0.67




                           December 31,
                               2021
Risk-free interest rate     0.85% - 1.14 %
Expected term in years       2.59 - 4.15
Expected volatility                 98.5 %
Expected dividends                     0 %
Market Price              $         3.90




SPAC Warrants



Public SPAC Warrants



Participants in KBL's initial public offering received an aggregate of
11,500,000 warrants ("Public SPAC Warrants"). Each Public SPAC Warrant entitles
the holder to purchase one-half of one share of the Company's common stock at an
exercise price of $5.75 per half share ($11.50 per whole share) until November
6, 2025, subject to adjustment. No fractional shares will be issued upon
exercise of the Public SPAC Warrants. Management has determined that the Public
SPAC Warrants contain a tender offer provision which could result in the Public
SPAC Warrants settling for the tender offer consideration (including potentially
cash) in a transaction that didn't result in a change-in-control. This feature
results in the Public SPAC Warrants being precluded from equity classification.
Accordingly, the Public SPAC Warrants are classified as liabilities measured at
fair value, with changes in fair value each period reported in earnings. The
Public SPAC Warrants were revalued on September 30, 2022 at $592,250, which
resulted in decreases of $1,246,600 and $7,456,600 in the fair value of the
derivative liabilities during the three and nine months ended September 30,

2022, respectively.



                                       13





Private SPAC Warrants



Participants in KBL's initial private placement in connection with its initial
public offering received an aggregate of 502,500 warrants ("Private SPAC
Warrants"). Each Private SPAC Warrant entitles the holder to purchase one-half
of one share of the Company's common stock at an exercise price of $5.75 per
half share ($11.50 per whole share) until November 6, 2025, subject to
adjustment. No fractional shares will be issued upon exercise of the Private
SPAC Warrants. Management has determined that the Private SPAC Warrants contain
a tender offer provision which could result in the Private SPAC Warrants
settling for the tender offer consideration (including potentially cash) in a
transaction that didn't result in a change-in-control. This feature (amongst
others) results in the Private SPAC Warrants being precluded from equity
classification. Accordingly, the Private SPAC Warrants are classified as
liabilities measured at fair value, with changes in fair value each period
reported in earnings. The Private SPAC Warrants were revalued on September 30,
2022 at $20,100, which resulted in decreases of $10,050 and $447,225 in the fair
value of the derivative liabilities during the three and nine months ended
September 30, 2022, respectively.



PIPE Warrants



On February 23, 2021, the Company issued five-year warrants (the "PIPE
Warrants") to purchase 2,564,000 shares of common stock at an exercise price of
$5.00 per share in connection with a private placement offering. The PIPE
Warrants did not meet the requirements for equity classification due to the
existence of a tender offer provision that could potentially result in cash
settlement of the PIPE Warrants that didn't meet the limited exception in the
case of a change-in-control. Accordingly, the PIPE Warrants are
liability-classified and the Company recorded the $7,294,836 fair value of the
PIPE Warrants, which was determined using the Black-Scholes option pricing
model, as derivative liabilities. The PIPE Warrants were revalued on September
30, 2022 at $433,600, which resulted in decreases of $188,000 and $6,082,700 in
the fair value of the derivative liabilities during the three and nine months
ended September 30, 2022, respectively.



Other Warrants



AGP Warrant



In connection with the transactions contemplated by the Company's Business
Combination Agreement (as amended, the "Business Combination Agreement"), dated
as of July 25, 2019 (the "Business Combination"), on November 6, 2020, the
Company became obligated to assume five-year warrants for the purchase of 63,658
shares of the Company's common stock at an exercise price of $5.28 per share
(the "Alliance Global Partners Warrant Liability" or "AGP Warrant Liability")
that had originally been issued by KBL to an investment banking firm in
connection with a prior private placement.



On March 12, 2021, the Company issued a warrant to Alliance Global Partners
("AGP" and the "AGP Warrant") to purchase up to an aggregate of 63,658 shares of
the Company's common stock at a purchase price of $5.28 per share, subject to
adjustment, in full satisfaction of the AGP Warrant Liability. The exercise of
the AGP Warrant is limited at any given time to prevent AGP from exceeding
beneficial ownership of 4.99% of the then total number of issued and outstanding
shares of the Company's common stock upon such exercise. The warrant is
exercisable at any time between May 2, 2021 and May 2, 2025. The AGP Warrant did
not meet the requirements for equity classification due to the existence of a
tender offer provision that could potentially result in cash settlement of the
AGP Warrant that did not meet the limited exception in the case of a
change-in-control. Accordingly, the AGP Warrant will continue to be
liability-classified. The AGP Warrant was revalued on September 30, 2022 at
$6,633, which resulted in decreases of $3,762 and $137,698 in the fair value of
the derivative liabilities during the three and nine months ended September

30,
2022, respectively.



                                       14





Alpha Warrant



In connection with that certain Mutual Release and Settlement Agreement dated
July 31, 2021 (agreed to on July 29, 2021) between the Company and Alpha Capital
Anstalt ("Alpha" and the "Alpha Settlement Agreement"), the Company issued a
three-year warrant for the purchase of 25,000 shares of the Company's common
stock at an exercise price of $7.07 per share (the "Alpha Warrant Liability" and
the "Alpha Warrant"). The exercise of shares of the Alpha Warrant is limited at
any given time to prevent Alpha from exceeding a beneficial ownership of 4.99%
of the then total number of issued and outstanding shares of the Company's
common stock upon such exercise. The warrant is exercisable until August 2,
2024. The Alpha Warrant did not meet the requirements for equity classification
due to the existence of a tender offer provision that could potentially result
in cash settlement of the Alpha Warrant that did not meet the limited exception
in the case of a change-in-control. Accordingly, the Alpha Warrant is
liability-classified and the Company recorded the $95,677 fair value of the
Alpha Warrant, which was determined using the Black-Scholes option pricing
model, as a derivative liability. The Alpha Warrant was revalued on September
30, 2022 at $224, which resulted in decreases of $1,496 and $43,337 in the fair
value of the derivative liabilities during the three and nine months ended
September 30, 2022, respectively.



Warrant Activity



A summary of the warrant activity (including certain warrants granted in August
2021 and July 2022 as part of private offerings, both of which are
equity-classified) during the nine months ended September 30, 2022 is presented
below:



                                                                            Weighted
                                                             Weighted        Average
                                                             Average        Remaining
                                            Number of        Exercise        Life in          Intrinsic
                                             Warrants         Price           Years             Value

Outstanding, December 31, 2021               11,153,908     $     9.06
       4.1       $          -
Issued                                        8,764,152           0.74             5.3          1,750,067
Exercised                                    (1,547,076 )       0.0001               - (1)     (1,028,651 )
Cancelled                                             -              -               -                  -
Expired                                               -              -               -                  -

Outstanding, September 30, 2022              18,370,984     $     5.77

3.8 (1) $ 721,417


Exercisable, September 30, 2022              12,238,908     $     8.13             3.0            721,417



(1) Note that the July 2022 Pre-funded Warrants are exercisable until they are

exercised in full and have no expiration date; as such, they have been

excluded from this calculation.






A summary of outstanding and exercisable warrants as of September 30, 2022 is
presented below:



   Warrants Outstanding                 Warrants Exercisable
                                  Weighted
                                   Average
Exercise       Number of          Remaining               Number of
  Price          Shares         Life in Years               Shares
$    5.00        2,564,000                 3.4              2,564,000
$    5.28           63,658                 2.6                 63,658
$    7.07           25,000                 1.8                 25,000
$    7.50        2,500,000                 3.9              2,500,000
$   11.50        6,001,250                 3.1              6,001,250
$    1.06        6,132,076                   -  (1)                 - (1)
$  0.0001        1,085,000                   -  (2)         1,085,000
                18,370,984                 3.3  (1)  (2)   12,238,908


(1) Note that the July 2022 Common Warrants are exercisable for 5 years following

the initial exercise date, which is six months following the closing of the

July 2022 Offering, or January 20, 2023.

(2) Note that the July 2022 Pre-funded Warrants are exercisable until they are


     exercised in full and have no expiration date; as such, they have been
     excluded from this calculation.




                                       15





NOTE 7 - LOANS PAYABLE



Loans Payable


The following table summarizes the activity of loans payable during the nine months ended September 30, 2022:





                             Principal                                                                Effect of         Principal
                             Balance at                          Principal                             Foreign         Balance at
                            December 31,                         Repaid in                            Exchange        September 30,
                                2021           Forgiveness          Cash          Adjustment            Rates             2022
Paycheck Protection
Program                    $       41,312     $           -     $    (41,312 )   $          -        $         -     $             -
Bounce Back Loan Scheme            61,169                 -           (6,711 )              -            (12,000 )            42,458
First Assurance Funding         1,618,443                 -       (1,443,963 )        (14,042 )(1)             -             160,438
Other loans payable               155,320                 -                -           (5,000 )(2)             -             150,320
Total loans payable        $    1,876,244     $           -     $ (1,491,986 )   $    (19,042 )      $   (12,000 )   $       353,216
Less: loans payable -
current portion                 1,828,079                                                                                    321,694
Loans payable -
noncurrent portion         $       48,165                                                                            $        31,522

(1) Note that this amount was related to finance charges and was reclassified.

(2) Note that this amount was reclassified to related party payables.


During the three months ended September 30, 2022, the Company paid $481,321 and
$2,692 in partial satisfaction of the First Assurance Funding loan and the
Bounce Back Loan Scheme, respectively. During the nine months ended September
30, 2022, the Company paid an aggregate of $1,443,963 and $6,711 in partial
satisfaction of the First Assurance Funding loan and the Bounce Back Loan
Scheme, respectively, and paid $41,312 in full satisfaction of the Paycheck
Protection Program loan.



Loans Payable - Related Parties





The below table summarizes the activities of loans payable - related parties
during the nine months ended September 30, 2022 (see Note 10 - Related Parties
for additional details):



                                                 Principal                          Effect of         Principal
                                                Balance at          Reclass          Foreign         Balance at
                                               December  31,       from Loans       Exchange        September 30,
                                                   2021             Payable           Rates             2022

Loans payable issued between September 18, 2019 through November 4, 2020 $ 81,277 $ 5,000 $ (1,521 ) $ 84,756

Interest Expense on Loans Payable





For the three months ended September 30, 2022 and 2021, the Company recognized
interest expense associated with loans payable of $7,348 and $2,315,
respectively, and interest expense - related parties associated with loans
payable of $1,536 and $10,566, respectively. During the nine months ended
September 30, 2022 and 2021, the Company recognized interest expense associated
with loans payable of $22,117 and $20,498, respectively, and interest income
(expense) - related parties associated with loans payable of $1,495 and
($30,898), respectively.



As of September 30, 2022, the Company had accrued interest and accrued
interest - related parties associated with loans payable of $32,914 and $16,676,
respectively. As of December 31, 2021, the Company had accrued interest and
accrued interest - related parties associated with loans payable of $24,212 and
$812, respectively. See Note 10 - Related Parties for additional details.



                                       16




NOTE 8 - COMMITMENTS AND CONTINGENCIES

Litigation and Other Loss Contingencies


The Company records liabilities for loss contingencies arising from claims,
assessments, litigation, fines, penalties and other sources when it is probable
that a liability has been incurred and the amount of the loss can be reasonably
estimated. The Company has no liabilities recorded for loss contingencies as of
December 31, 2021. See Legal Matters - Action Against Former Executive of KBL
below for information related to a September 30, 2022 accrual.



Legal Matters


Action Against Former Executive of KBL





On September 1, 2021, the Company initiated legal action in the Chancery Court
of Delaware against Dr. Marlene Krauss, the Company's former Chief Executive
Officer and director ("Dr. Krauss") and two of her affiliated companies, KBL IV
Sponsor, LLC and KBL Healthcare Management, Inc. (collectively, the "KBL
Affiliates") for, among other things, engaging in unauthorized monetary
transfers of the Company's assets, non-disclosure of financial liabilities
within the Company's Consolidated Financial Statements, issuing shares of stock
without proper authorization; and improperly allowing stockholder redemptions to
take place. The Company's complaint alleges causes of action against Dr. Krauss
and/or the KBL Affiliates for breach of fiduciary duties, ultra vires acts,
unjust enrichment, negligence and declaratory relief, and seeks compensatory
damages in excess of $11,286,570, together with interest, attorneys' fees and
costs. There can be no assurance that the Company will be successful in its
legal actions. As of September 30, 2022, the Company has a legal accrual of
$218,217 recorded to cover the legal expenses of the former executives of KBL.



On October 5, 2021, Dr. Krauss and the KBL Affiliates filed an Answer,
Counterclaims and Third-Party Complaint (the "Krauss Counterclaims") against the
Company and twelve individuals who are, or were, directors and/or officers of
the Company, i.e., Marc Feldmann, Lawrence Steinman, James N.
Woody, Teresa DeLuca, Frank Knuettel II, Pamela Marrone, Lawrence Gold, Donald
A. McGovern, Jr., Russell T. Ray, Richard W. Barker, Shoshana Shendelman and
Ozan Pamir (collectively, the "Third-Party Defendants"). On October 27, 2021,
the Company and Ozan Pamir filed an Answer to the Krauss Counterclaims, and all
of the other Third-Party Defendants filed a Motion to Dismiss as to the
Third-Party Complaint.



On January 28, 2022, in lieu of filing an opposition to the Motion to Dismiss,
Dr. Krauss and the KBL Affiliates filed a Motion for leave to file amended
counterclaims and third-party complaint, and to dismiss six of the current and
former directors previously named, i.e., to dismiss Teresa DeLuca, Frank
Knuettel II, Pamela Marrone, Russell T. Ray, Richard W. Barker and Shoshana
Shendelman.  The Motion was granted by stipulation and, on February 24, 2022,
Dr. Krauss filed an amended Answer, Counterclaims and Third-Party Complaint (the
"Amended Counterclaims").  In essence, the Amended Counterclaims allege (a) that
the Company and the remaining Third-Party Defendants breached fiduciary duties
to Dr. Krauss by making alleged misstatements against Dr. Krauss in SEC filings
and failing to register her shares in the Company so that they could be traded,
and (b) the Company breached contracts between the Company and Dr. Krauss for
registration of such shares, and also failed to pay to Dr. Krauss the amounts
alleged to be owing under a promissory note in the principal amount of $371,178,
plus an additional $300,000 under Dr. Krauss's resignation agreement. The
Amended Counterclaims seek unspecified amounts of monetary damages, declaratory
relief, equitable and injunctive relief, and attorney's fees and costs.



On March 16, 2022, Donald A. McGovern, Jr. and Lawrence Gold filed a Motion to
Dismiss the Amended Counterclaims against them, and the Company and the
remaining Third-Party Defendants filed an Answer to the Amended Counterclaims
denying the same.  On April 19, 2022, Dr. Krauss stipulated to dismiss all of
her counterclaims and allegations against both Donald A. McGovern, Jr. and
Lawrence Gold, thereby mooting their Motion to Dismiss the Amended Counterclaims
against them. The Company and the Third-Party Defendants intend to continue to
vigorously defend against all of the Amended Counterclaims, however, there can
be no assurance that they will be successful in the legal defense of such
Amended Counterclaims. In April 2022, Donald A. McGovern, Jr. and Lawrence Gold
were dismissed from the lawsuit as parties. Discovery has not yet commenced

in
the case.



                                       17




Action Against the Company by Dr. Krauss


On August 19, 2021, Dr. Krauss initiated legal action in the Chancery Court of
Delaware against the Company.  The original Complaint sought expedited relief
and made the following two claims: (1) it alleged that the Company is obligated
to advance expenses including, attorney's fees, to Dr. Krauss for the costs of
defending against the SEC and certain Subpoenas served by the SEC on Dr. Krauss;
and (2) it alleged that the Company is also required to reimburse Dr. Krauss for
the costs of bringing this lawsuit against the Company. On or about September 3,
2021, Dr. Krauss filed an Amended and Supplemental Complaint (the "Amended
Complaint") in this action, which added the further claims that Dr. Krauss is
also allegedly entitled to advancement by the Company of her expenses, including
attorney's fees, for the costs of defending against the Third-Party Complaint in
the Tyche Capital LLC action referenced below, and the costs of defending
against the Company's own Complaint against Dr. Krauss as described above. On or
about September 23, 2021, the Company filed its Answer to the Amended Complaint
in which the Company denied each of Dr. Krauss' claims and further raised
numerous affirmative defenses with respect thereto.



On November 15, 2021, Dr. Krauss filed a Motion for Summary Adjudication as to
certain of the issues in the case, which was opposed by the Company.  A hearing
on such Motion was held on December 7, 2021, and, on March 7, 2022, the Court
issued a decision in the matter denying the Motion for Summary Adjudication in
part and granting it in part.  The Court then issued an Order implementing such
a decision on March 29, 2022. The parties are now engaging in proceedings set
forth in that implementing Order. The Court granted Dr. Krauss's request for
advancement of some of the legal fees which Dr. Krauss requested in her Motion,
and the Company was required to pay a portion of those fees while it objects to
the remaining portion of disputed fees. These legal fees have been accrued on
the Company's balance sheet as of September 30, 2022. On October 10, 2022, Dr.
Krauss filed an Application to compel the Company to pay the full amount of fees
requested by Dr. Krauss for May-July 2022, and to modify the Court's Order. The
Company has filed its Opposition thereto, but no hearing has yet been scheduled
by the Court for the Application. Notwithstanding any requirement by the Court
for the Company to advance attorneys' fees to Dr. Krauss, no adjudication has
yet been made as to whether Dr. Krauss will ultimately be entitled to
permanently retain such advancements. The Company is seeking payment for a
substantial portion of such amounts from its director and officers' insurance
policy, of which no assurance can be provided that the directors and officers
insurance policy will cover such amounts. See "Declaratory Relief Action Against
the Company by AmTrust International" below.



Action Against Tyche Capital LLC





The Company commenced and filed an action against defendant Tyche Capital LLC
("Tyche") in the Supreme Court of New York, in the County of New York, on April
15, 2021.  In its Complaint, the Company alleged claims against Tyche arising
out of Tyche's breach of its written contractual obligations to the Company as
set forth in a "Guarantee And Commitment Agreement" dated July 25, 2019, and a
"Term Sheet For KBL Business Combination With CannBioRex" dated April 10, 2019
(collectively, the "Subject Guarantee").  The Company alleges in its Complaint
that, notwithstanding demand having been made on Tyche to perform its
obligations under the Subject Guarantee, Tyche has failed and refused to do so,
and is currently in debt to the Company for such failure in the amount of
$6,776,686, together with interest accruing thereon at the rate set forth in the
Subject Guarantee.



On or about May 17, 2021, Tyche responded to the Company's Complaint by filing
an Answer and Counterclaims against the Company alleging that it was the
Company, rather than Tyche, that had breached the Subject Guarantee.  Tyche also
filed a Third-Party Complaint against six third-party defendants, including
three members of the Company's management, Sir Marc Feldmann, Dr. James Woody,
and Ozan Pamir (collectively, the "Individual Company Defendants"), claiming
that they allegedly breached fiduciary duties to Tyche with regards to the
Subject Guarantee. In that regard, on June 25, 2021, each of the Individual
Company Defendants filed a Motion to Dismiss Tyche's Third-Party Complaint
against them.



On November 23, 2021, the Court granted the Company's request to issue an Order
of attachment against all of Tyche's shares of the Company's stock that had been
held in escrow.  In so doing, the Court found that the Company had demonstrated
a likelihood of success on the merits of the case based on the facts alleged in
the Company's Complaint.



On February 18, 2022, Tyche filed an Amended Answer, Counterclaims and
Third-Party Complaint.  On March 22, 2022, the Company and each of the
Individual Company Defendants filed a Motion to Dismiss all of Tyche's claims. A
hearing on such Motion to Dismiss was held on August 25, 2022, and the Court
granted the Motion to Dismiss entirely as to each of the Individual Company
Defendants, and also as to three of the four Counterclaims brought against the
Company, only leaving Tyche's declaratory relief claim. On September 9, 2022,
Tyche filed a Notice of Appeal as to the Court's decision, which has not yet
been briefed or adjudicated. On August 26, 2022, Tyche filed a Motion to vacate
or modify the Company's existing attachment Order against Tyche's shares of the
Company's stock held in escrow. The Company has filed its Opposition thereto,
and a hearing on such Motion has been set for January 5, 2023. The Company
and the Individual Company Defendants intend to continue to vigorously defend
against all of Tyche's claims, however, there can be no assurance that they will
be successful in the legal defense of such claims. Written discovery proceedings
have commenced among the parties.



                                       18




Action Against Ronald Bauer & Samantha Bauer





The Company and two of its wholly-owned subsidiaries, Katexco Pharmaceuticals
Corp. and CannBioRex Pharmaceuticals Corp. (collectively, the "Company
Plaintiffs"), initiated legal action against Ronald Bauer and Samantha Bauer, as
well as two of their companies, Theseus Capital Ltd. and Astatine Capital Ltd.
(collectively, the "Bauer Defendants"), in the Supreme Court of British Columbia
on February 25, 2022. The Company Plaintiffs are seeking damages against the
Bauer Defendants for misappropriated funds and stock shares, unauthorized stock
sales, and improper travel expenses, in the combined sum of at least $4,395,000
CAD [$3,178,025 USD] plus the additional sum of $2,721,036 USD. The Bauer
Defendants filed an answer to the Company Plaintiffs' claims on May 6, 2022.
There can be no assurance that the Company Plaintiffs will be successful in

this
legal action.


Declaratory Relief Action Against the Company by AmTrust International


On June 29, 2022, AmTrust International Underwriters DAC ("AmTrust"), which was
the premerger directors and officers insurance policy underwriter for KBL, filed
a declaratory relief action against the Company in the U.S. District Court for
the Northern District of California (the "Declaratory Relief Action") seeking
declaration of AmTrust's obligations under the directors and officers insurance
policy.  In the Declaratory Relief Action, AmTrust is claiming that as a
result of the merger the Company is no longer the insured under the subject
insurance policy, notwithstanding the fact that the fees which the Company seeks
to recover from AmTrust relate to matters occurring prior to the merger.



On September 20, 2022, the Company filed its Answer and Counterclaims against
AmTrust for bad faith breach of AmTrust's insurance coverage obligations to the
Company under the subject directors and officers insurance policy, and seeking
damages of at least $2 million in compensatory damages, together with applicable
punitive damages. In addition, the Company brought a Third-Party Complaint
against its excess insurance carrier, Freedom Specialty Insurance Company
("Freedom") seeking declaratory relief that Freedom will also be required to
honor its policy coverage as soon as the amount of AmTrust's insurance coverage
obligations to the Company have been exhausted. On October 25, 2022, AmTrust
filed its Answer to the Company's Counterclaims, however, Freedom's response to
the Third-Party Complaint is not yet due. As of September 30, 2022, the Company
has recorded an insurance claims receivable of $1,836,940, which it believes is
the net recoverable amount advanced to former directors and officers of the
Company as of September 30, 2022.  While the Company believes it has a strong
case against AmTrust, there can be no assurance that the Company will prevail in
this action.



NOTE 9 - STOCKHOLDERS' EQUITY



Common Stock


Common Stock Issued for Services





During the three and nine months ended September 30, 2022, the Company issued an
aggregate 55,112 and 151,010, respectively, of immediately vested shares of the
Company's common stock as compensation to consultants, directors, and officers,
with an aggregate issuance date fair value of $60,622 and $270,967,
respectively, which was charged immediately to the condensed consolidated
statement of operations for the three and nine months ended September 30, 2022.



Restricted Stock Shares



During the three and nine months ended September 30, 2022, the Company issued
zero and 12,000 restricted shares of the Company's common stock, or Restricted
Stock Shares, as of the end of both periods as compensation to consultants with
an issuance date fair value of zero and $48,600 as of the end of both periods.
Per the two year consulting agreement which evidences the issuance of the 12,000
restricted shares during the nine months ended September 30, 2022, the
Restricted Stock Shares are issued at the beginning of the contract term and
annually and vest monthly over a period of 24 months. The Company recognized
stock-based compensation expense related to the amortization of the Restricted
Stock Shares of $6,075 and $20,250 for the three and nine months ended September
30, 2022.



                                       19




Below is a table summarizing the Restricted Stock Shares granted and outstanding as of and for the nine months ended September 30, 2022:





                                                                          Weighted
                                                                          Average
                                                          Unvested         Grant
                                                         Restricted         Date
                                                           Stock          FV Price

Unvested as of January 1, 2022                                     -     $ 

      -
Granted                                                       12,000           4.05
Vested                                                         5,000           4.05

Unvested as of September 30, 2022                              7,000       

4.05


Total unrecognized expense remaining                    $     28,350
Weighted-average years expected to be recognized over           1.25       

      -




Stock Options



A summary of the option activity during the nine months ended September 30, 2022
is presented below:



                                                            Weighted        Weighted
                                                            Average          Average
                                            Number of       Exercise        Remaining        Intrinsic
                                             Options         Price        Term (Years)         Value
Outstanding, January 1, 2022                 2,741,000           4.77               9.4          70,500
Granted                                        518,121           1.36                 -               -
Exercised                                            -              -                 -               -
Expired                                              -              -                 -               -
Forfeited                                            -              -                 -               -

Outstanding, September 30, 2022              3,259,121           4.23      

8.8 $ -


Exercisable, September 30, 2022              1,660,057           4.16      

        8.7     $         -



For options issued during the nine months ended September 30, 2022, the assumptions used in the Black Scholes valuation method were as follows:





Risk-free interest rate          2.88 %
Expected term in years      5.00-5.77
Expected volatility             91.00 %
Expected dividends                  0 %




A summary of outstanding and exercisable stock options as of September 30, 2022
is presented below:



    Stock Options Outstanding                Stock Options Exercisable
                                         Weighted
                                          Average
Exercise            Number of            Remaining              Number of
  Price              Shares            Life in Years              Shares
$    2.49                  50,000                 8.2                   50,000
$    4.43               1,580,000                 8.4                  983,111
$    7.56                 436,000                 8.8                  127,167
$    3.95                 675,000                 9.2                  301,042
$    1.36                 518,121                 9.6                  198,737
                        3,259,121                 8.7                1,660,057




                                       20





The Company recognized stock-based compensation expense of $672,083 and
$2,273,947 for the three and nine months ended September 30, 2022, respectively,
related to the issuance of shares to consultants and directors for services
provided, as well as for the amortization of stock options and restricted stock
shares. Expense of $584,237 and $1,959,919 is included within general and
administrative expenses on the condensed consolidated statements of operations
for the three and nine month periods, respectively, and expense of $87,846 and
$314,028 is included within research and development expenses on the condensed
consolidated statements of operations for the three and nine month periods,
respectively. The full amount of stock-based compensation recognized for the
three and nine month periods ended September 30, 2022 is considered to be
related party expense. Stock-based compensation expense related to the
amortization of stock options for the three and nine months ended September 30,
2021 was $434,979 and $1,871,473, respectively; these expenses were included
within general and administrative expenses or research and development expenses
on the condensed consolidated statement of operations for both of those periods.
The full amount of stock-based compensation recognized for the three and nine
month periods ended September 30, 2021, respectively, was considered to be
related party expense. As of September 30, 2022, there was $4,827,266 of
unrecognized stock-based compensation expense related to stock options that will
be recognized over the weighted average remaining vesting period of 2.3 years,
as well as $28,350 of unrecognized expense related to Restricted Stock Shares
that will be recognized over the weighted average remaining vesting period

of
1.3 years.



July 2022 Offering



On July 17, 2022, the Company entered into a Securities Purchase Agreement with
certain purchasers, pursuant to which the Company agreed to sell an aggregate of
3,500,000 shares of common stock, pre-funded warrants to purchase up to an
aggregate of 2,632,076 shares of common stock ("July 2022 Pre-Funded Warrants"),
and common stock warrants to purchase up to an aggregate of 6,132,076 shares of
common stock (the "July 2022 Common Warrants"), at a combined purchase price of
$1.06 per share and warrant (the "July 2022 Offering"). Aggregate gross proceeds
from the July 2022 Offering were $6,499,737. The July 2022 Offering closed

on
July 20, 2022.



The July 2022 Pre-Funded Warrants have an exercise price equal to $0.0001, are
immediately exercisable and are subject to customary anti-dilution adjustments
for stock splits or dividends or other similar transactions. The exercise price
of the July 2022 Pre-Funded Warrants will not be subject to adjustment as a
result of subsequent equity issuances at effective prices lower than the
then-current exercise price. The July 2022 Pre-Funded Warrants are exercisable
until they are exercised in full. The July 2022 Pre-Funded Warrants are subject
to a provision prohibiting the exercise of such July 2022 Pre-Funded Warrants to
the extent that, after giving effect to such exercise, the holder of such July
2022 Pre-Funded Warrants (together with the holder's affiliates, and any other
persons acting as a group together with the holder or any of the holder's
affiliates), would beneficially own in excess of 9.99% of the Company's
outstanding common stock (which may be increased or decreased, with 61 days
prior written notice by the holder). Although the July 2022 Pre-Funded Warrants
have a tender offer provision, the July 2022 Pre-Funded Warrants were determined
to be equity-classified because they met the limited exception in the case of a
change-in-control. Because the July 2022 Pre-Funded Warrants are
equity-classified, the placement agent fees and offering expenses will be
accounted for as a reduction of additional paid in capital.



The July 2022 Common Warrants have an exercise price equal to $1.06 per share,
are exercisable 6 months following the closing of the July 2022 Offering (the
"Initial Exercise Date") and are subject to customary anti-dilution adjustments
for stock splits or dividends or other similar transactions. The exercise price
of the July 2022 Common Warrants will not be subject to adjustment as a result
of subsequent equity issuances at effective prices lower than the then-current
exercise price. The July 2022 Common Warrants are exercisable for 5 years
following the Initial Exercise Date. The July 2022 Common Warrants are subject
to a provision prohibiting the exercise of such July 2022 Common Warrants to the
extent that, after giving effect to such exercise, the holder of such July 2022
Common Warrants (together with the holder's affiliates, and any other persons
acting as a group together with the holder or any of the holder's affiliates),
would beneficially own in excess of 4.99% of the Company's outstanding common
stock (which may be increased or decreased, with 61 days prior written notice by
the holder). Although the July 2022 Common Warrants have a tender offer
provision, the July 2022 Common Warrants were determined to be equity-classified
because they met the limited exception in the case of a change-in-control.
Because the July 2022 Common Warrants are equity-classified, the placement agent
fees and offering expenses will be accounted for as a reduction of additional
paid in capital.



As of September 30, 2022, 1,547,076 of the July 2022 Pre-Funded Warrants have
been exercised for a value of $155; there are 1,085,000 unexercised July 2022
Pre-Funded Warrants remaining as of the end of the period. No July 2022 Common
Warrants have been exercised as of September 30, 2022.



                                       21





NOTE 10 - RELATED PARTIES


Accrued Expenses - Related Parties





Accrued expenses - related parties was $158,467 as of September 30, 2022 and
consists of $16,676 of interest accrued on loans due to a certain investor in
the Company and $141,791 of accrued consulting fees for services provided by
certain directors and consultants of the Company. Accrued expenses - related
parties of $18,370 as of December 31, 2021, consists of interest accrued on
loans and convertible notes due to certain officers and directors of the
Company.



Loans Payable - Related Parties


Loans payable - related parties totaled $84,756 and $81,277 as of September 30,
2022 and December 31, 2021, respectively. See Note 7 - Loans Payable for more
information.


Research and Development Expenses - Related Parties

Research and Development Expenses - Related Parties of $53,347 and $298,879 during the three months ended September 30, 2022 and 2021, respectively, and $158,401 and $1,287,583 during the nine months ended September 30, 2022 and 2021, respectively, are related to consulting and professional fees paid to current or former officers, directors or greater than 5% stockholders, or affiliates thereof.

General and Administrative Expenses - Related Parties





General and Administrative Expenses - Related Parties during the three months
ended September 30, 2022 and 2021 were $0 and $82,519, respectively. These
expenses relate to professional fees paid to current or former officers,
directors or greater than 5% stockholders, or affiliates thereof. General and
Administrative Expenses - Related Parties during the nine months ended September
30, 2022 and 2021 were $5,261 and $462,081, respectively. These expenses relate
to professional fees paid to current or former officers, directors or greater
than 5% stockholders, or affiliates thereof.



                                       22




Interest (Expense) Income - Related Parties





During the three and nine months ended September 30, 2022, the Company recorded
($1,536) and $1,495, respectively, of interest (expense) income - related
parties related to loans from greater than 5% stockholders or affiliates of

the
Company.



During the three months and nine months ended September 30, 2021, the Company
recorded $14,201 and $42,279, respectively, of interest expense - related
parties, of which $3,633 and $11,380, respectively, related to interest on
certain convertible notes held by officers and directors of the Company and
$10,567 and $30,899, respectively, related to interest expense on loans from
officers, directors greater than 5% stockholders, or affiliates thereof, of

the
Company.



NOTE 11 - SUBSEQUENT EVENTS


Oxford University Research Agreement


On October 24, 2022, the Company entered into a new research agreement with
Oxford University related to the license agreement signed in November 2021,
whereby it was granted rights to certain patents related to the HMGB1 molecule
for liver regeneration. Pursuant to this agreement, the term of the contract is
for one year, beginning on January 1, 2023; the financial terms of the contract
are a commitment of £125,000 per quarter, with the first payment due in April
2023. Any outstanding amounts will earn interest at a rate of 4% per annum.




Directors' Compensation



On October 31, 2022, the Board of Directors of the Company approved the issuance
of 129,483 shares of $0.0001 par value common stock, in lieu of cash
compensation, to certain independent directors under the Company's 2022 Omnibus
Incentive Plan as consideration for services rendered during the third quarter
of 2022. The shares were valued at the closing sales price on October 31, 2022,
the date such issuances were approved by the Board of Directors.



Exercise of July 2022 Pre-funded Warrants





On November 1, 2022, the remainder, or 1,085,000, of the July 2022 Pre-Funded
Warrants were exercised for a value of $109; there are no remaining outstanding
July 2022 Pre-Funded Warrants.



Notice of a Special Meeting of Stockholders to Effect a Reverse Stock Split



On November 4, 2022, the Company filed a Pre-Schedule 14A with the SEC providing
notice of a special meeting of stockholders of the Company on December 15, 2022
to approve an amendment to the Second Amended and Restated Certificate of
Incorporation, as amended, to effect a reverse stock split of the issued and
outstanding shares common stock, par value $0.0001 per share, by a ratio of
between one-for-four to one-for-twenty, inclusive, with the exact ratio to be
set at a whole number to be determined by the Board of Directors or a duly
authorized committee thereof in its discretion, at any time after the approval
of the amendment and prior to December 15, 2023.



                                       23




ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations





              CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS



This Quarterly Report on Form 10-Q ("Report"), including "Management's
Discussion and Analysis of Financial Condition and Results of Operations,"
contains forward-looking statements, within the federal securities laws,
including the Private Securities Litigation Reform Act of 1995, regarding future
events and the future results of the Company that are based on current
expectations, estimates, forecasts, and projections about the industry in which
the Company operates and the beliefs and assumptions of the management of the
Company. Words such as "expects," "anticipates," "targets," "goals," "projects,"
"intends," "plans," "believes," "seeks," "estimates," variations of such words,
and similar expressions are intended to identify such forward-looking
statements. These forward-looking statements are only predictions and are
subject to risks, uncertainties and assumptions that are difficult to predict.
Therefore, actual results may differ materially and adversely from those
expressed in any forward-looking statements. Factors that might cause or
contribute to such differences include, but are not limited to, those discussed
elsewhere in this Report, including under "Risk Factors", and in other reports
the Company files with the Securities and Exchange Commission ("SEC"), including
the Company's Annual Report on Form 10-K for the year ended December 31, 2021,
as filed with the SEC on March 31, 2022 (under the heading "Risk Factors" and in
other parts of that report), and include, but are not limited to, statements
about:


? Expectations for the clinical and preclinical development, manufacturing,


    regulatory approval, and commercialization of our product candidates;



? the uncertainties associated with the clinical development and regulatory

approval of the Company's drug candidates, including potential delays in the

enrollment and completion of clinical trials, issues raised by the U.S. Food

and Drug Administration (FDA) and the U.K. Medicines and Healthcare products


    Regulatory Agency (MHRA);

  ? regulatory developments in the United States and foreign countries;



? our success in retaining or recruiting, or changes required in, our officers,


    key employees or directors;



? current negative operating cash flows and our potential ability to obtain

additional financing to advance our business and the terms of any further


    financing, which may be highly dilutive and may include onerous terms;



? the continued impact of the COVID-19 pandemic on our business operations and


    our research and development initiatives;



? the accuracy of our estimates regarding expenses, future revenues and capital


    requirements;



? the Company's reliance on third parties to conduct its clinical trials, enroll

patients, and manufacture its preclinical and clinical drug supplies;

? the ability to come to mutually agreeable terms with such third parties and


    partners, and the terms of such agreements;

  ? estimates of patient populations for the Company's planned products;

? unexpected adverse side effects or inadequate therapeutic efficacy of drug

candidates that could limit approval and/or commercialization, or that could

result in recalls or product liability claims;

? the Company's ability to fully comply with numerous federal, state and local

laws and regulatory requirements, as well as rules and regulations outside the

United States, that apply to its product development activities;

? challenges and uncertainties inherent in product research and development,

including the uncertainty of clinical success and of obtaining regulatory

approvals; uncertainty of commercial success;

? the ability of the Company to execute its plans to develop and market new drug

products and the timing and costs of these development programs;

? high inflation, increasing interest rates and economic downturns, including

potential recessions, as well as macroeconomic, geopolitical, health and

industry trends, pandemics, acts of war (including the ongoing Ukraine/Russian

conflict) and other large-scale crises;

? estimates of the sufficiency of our existing capital resources combined with


    future anticipated cash flows to finance our operating requirements;



? our ability to maintain our listing on NASDAQ (including that we are not

currently in compliance with NASDAQ's continued listing requirements); and

? other risks and uncertainties, including those listed under "Risk Factors",


    below.




                                       24





All forward-looking statements speak only at the date of the filing of this
Report. The reader should not place undue reliance on these forward-looking
statements. Although we believe that our plans, intentions and expectations
reflected in or suggested by the forward-looking statements we make in this
Report are reasonable, we provide no assurance that these plans, intentions or
expectations will be achieved. We disclose important factors that could cause
our actual results to differ materially from our expectations under "Risk
Factors" and "Management's Discussion and Analysis of Financial Condition and
Results of Operations" and elsewhere in this Report and our Annual Report on
Form 10-K for the year ended December 31, 2021. These cautionary statements
qualify all forward-looking statements attributable to us or persons acting on
our behalf. Except as required by law, we assume no obligation to update or
revise these forward-looking statements for any reason, even if new information
becomes available in the future.



General Information



The following discussion is based upon our unaudited Condensed Consolidated
Financial Statements included elsewhere in this Report, which have been prepared
in accordance with U.S. generally accepted accounting principles. The
preparation of these financial statements requires us to make estimates and
judgments that affect the reported amounts of assets, liabilities, revenues and
expenses, and related disclosure of contingencies. We base our estimates on
historical experience and on various other assumptions that we believe to be
reasonable under 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 or conditions. Factors that could cause or
contribute to these differences include those discussed below and elsewhere in
this Report, and in other reports we file with the SEC, and in our most recent
Annual Report on Form 10-K. All references to years relate to the calendar year
ended December 31st of the particular year.



This information should be read in conjunction with the interim unaudited
condensed consolidated financial statements and the notes thereto included in
this Quarterly Report on Form 10-Q, and the audited financial statements and
notes thereto and "Part II. Other Information - Item 7. Management's Discussion
and Analysis of Financial Condition and Results of Operations", contained in our
Annual Report on Form 10-K for the year ended December 31, 2021, filed with the
Securities and Exchange Commission on March 31, 2022 (the "Annual Report").

Certain capitalized terms used below and otherwise defined below, have the meanings given to such terms in the footnotes to our unaudited condensed consolidated financial statements included above under "Part I - Financial Information" - "Item 1. Financial Statements".

Please see the section entitled "Glossary" beginning on page ii of our Annual Report for a list of abbreviations and definitions commonly used in the pharmaceutical and biotechnology industry which are used throughout this Report.


Our logo and some of our trademarks and tradenames are used in this Report. This
Report also includes trademarks, tradenames and service marks that are the
property of others. Solely for convenience, trademarks, tradenames and service
marks referred to in this Report may appear without the ®, ™ and SM symbols.
References to our trademarks, tradenames and service marks are not intended to
indicate in any way that we will not assert to the fullest extent under
applicable law our rights or the rights of the applicable licensors if any, nor
that respective owners to other intellectual property rights will not assert, to
the fullest extent under applicable law, their rights thereto. We do not intend
the use or display of other companies' trademarks and trade names to imply a
relationship with, or endorsement or sponsorship of us by, any other companies.



The market data and certain other statistical information used throughout this
Report are based on independent industry publications, reports by market
research firms or other independent sources that we believe to be reliable
sources. Industry publications and third-party research, surveys and studies
generally indicate that their information has been obtained from sources
believed to be reliable, although they do not guarantee the accuracy or
completeness of such information. We are responsible for all of the disclosures
contained in this Report, and we believe these industry publications and
third-party research, surveys and studies are reliable. While we are not aware
of any misstatements regarding any third-party information presented in this
Report, their estimates, in particular, as they relate to projections, involve
numerous assumptions, are subject to risks and uncertainties, and are subject to
change based on various factors, including those discussed under, and
incorporated by reference in, the section entitled "Item 1A. Risk Factors" of
this Report. These and other factors could cause our future performance to
differ materially from our assumptions and estimates. Some market and other data
included herein, as well as the data of competitors as they relate to the
Company, is also based on our good faith estimates.



See also "Cautionary Statement Regarding Forward-Looking Statements", above,
which includes information on forward-looking statements used herein and other
matters which are applicable to this Report, including, but not limited to this
"Item 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations."



                                       25





Unless the context requires otherwise, references to the "Company," "we," "us,"
"our," "180 Life", "180LS" and "180 Life Sciences Corp." refer specifically to
180 Life Sciences Corp. and its consolidated subsidiaries. References to "KBL"
refer to the Company prior to the November 6, 2020 Business Combination.



In addition, unless the context otherwise requires and for the purposes of this Report only:

"CAD" refers to Canadian dollars;

"Exchange Act" refers to the Securities Exchange Act of 1934, as amended;

"£" or "GBP" refers to British pounds sterling;

"SEC" or the "Commission" refers to the United States Securities and Exchange Commission; and

"Securities Act" refers to the Securities Act of 1933, as amended.





Additional Information



We file annual, quarterly, and current reports, proxy statements and other
information with the SEC. Our SEC filings are available to the public over the
Internet at the SEC's website at www.sec.gov and are available for download,
free of charge, soon after such reports are filed with or furnished to the SEC,
on the "Investors"-"SEC Filings"-"All SEC Filings" page of our website
at www.180lifesciences.com. Copies of documents filed by us with the SEC are
also available from us without charge, upon oral or written request to our
Secretary, who can be contacted at the address and telephone number set forth on
the cover page of this Report. Our website address is www.180lifesciences.com/.
The information on, or that may be accessed through, our website is not
incorporated by reference into this Report and should not be considered a part
of this Report.


Going Concern and Management Liquidity Plans


As of September 30, 2022, we had an accumulated deficit of $85,666,267 and
working capital of $1,789,844. In addition, for the nine months ended September
30, 2022, $9,200,830 of cash was used in operations and total cash decreased by
$4,635,869. The accompanying condensed consolidated financial statements have
been prepared assuming the Company will continue as a going concern. As we are
not generating revenues, we need to raise a significant amount of capital in
order to pay our debts and cover our operating costs. While the Company raised
money in August 2021 and July 2022 (see Note 2 - Going Concern and Management's
Plans), we expect to require additional funding in the future and there is no
assurance that we will be able to raise additional needed capital or that such
capital will be available under favorable terms.



We are subject to all the substantial risks inherent in the development of a new
business enterprise within an extremely competitive industry. Due to the absence
of a long-standing operating history and the emerging nature of the markets in
which we compete, we anticipate operating losses until we can successfully
implement our business strategy, which includes all associated revenue streams.
We may never achieve profitable operations or generate significant revenues.



We currently have a minimum monthly cash requirement spend of approximately
$900,000. We believe that in the aggregate, we will require significant
additional capital funding to support and expand the research and development
and marketing of our products, fund future clinical trials, repay debt
obligations, provide capital expenditures for additional equipment and
development costs, payment obligations, office space and systems for managing
the business, and cover other operating costs until our planned revenue streams
from products are fully-implemented and begin to offset our operating costs, if
ever.



Since our inception, we have funded our operations with the proceeds from equity
and debt financings. We have experienced liquidity issues due to, among other
reasons, our limited ability to raise adequate capital on acceptable terms. We
have historically relied upon the issuance of equity and promissory notes that
are convertible into shares of our common stock to fund our operations and have
devoted significant efforts to reduce that exposure. We anticipate that we will
need to issue equity to fund our operations and repay our outstanding debt for
the foreseeable future. If we are unable to achieve operational profitability or
we are not successful in securing other forms of financing, we will have to
evaluate alternative actions to reduce our operating expenses and conserve cash.



The accompanying condensed consolidated financial statements have been prepared
in accordance with accounting principles generally accepted in the United States
of America on a going concern basis, which contemplates the realization of
assets and the satisfaction of liabilities in the normal course of business.
Accordingly, the consolidated financial statements do not include any
adjustments relating to the recoverability of assets and classification of
liabilities that might be necessary should the Company be unable to continue as
a going concern. The consolidated financial statements included in this report
also include a going concern footnote.



                                       26





Additionally, wherever possible, our Board of Directors will attempt to use
non-cash consideration to satisfy obligations. In many instances, we believe
that the non-cash consideration will consist of restricted shares of our common
stock, preferred stock or warrants to purchase shares of our common stock. Our
Board of Directors has authority, without action or vote of the shareholders,
but subject to NASDAQ rules and regulations (which generally require shareholder
approval for any transactions which would result in the issuance of more than
20% of our then outstanding shares of common stock or voting rights representing
over 20% of our then outstanding shares of stock), to issue all or part of the
authorized but unissued shares of common stock, preferred stock or warrants to
purchase such shares of common stock. In addition, we may attempt to raise
capital by selling shares of our common stock, possibly at a discount to market
in the future. These actions will result in dilution of the ownership interests
of existing shareholders, may further dilute common stock book value, and that
dilution may be material. Such issuances may also serve to enhance existing
management's ability to maintain control of us, because the shares may be issued
to parties or entities committed to supporting existing management.



Organization of MD&A
Our Management's Discussion and Analysis of Financial Condition and Results of
Operations (the "MD&A") is provided in addition to the accompanying consolidated
financial statements and notes to assist readers in understanding our results of
operations, financial condition, and cash flows. MD&A is organized as follows:



? Business Overview and Recent Events. A summary of the Company's business and


    certain material recent events.




  ? Significant Financial Statement Components. A summary of the Company's
    significant financial statement components.



? Results of Operations. An analysis of our financial results comparing the


    three and nine months ended September 30, 2022 and 2021.



? Liquidity and Capital Resources. An analysis of changes in our balance sheets


    and cash flows and discussion of our financial condition.



? Critical Accounting Policies and Estimates. Accounting estimates that we


    believe are important to understanding the assumptions and judgments
    incorporated in our reported financial results and forecasts.



Business Overview and Recent Events





On November 6, 2020 ("Closing Date"), the Business Combination was consummated
following a special meeting of stockholders, where the stockholders of KBL
considered and approved, among other matters, a proposal to adopt a Business
Combination Agreement. Pursuant to the Business Combination Agreement, KBL
Merger Sub, Inc. merged with 180, with 180 continuing as the surviving entity
and becoming a wholly-owned subsidiary of KBL. As part of the Business
Combination, KBL issued 17,500,000 shares of common stock and equivalents to the
stockholders of 180, in exchange for all of the outstanding capital stock of
180. The Business Combination became effective November 6, 2020 and in
connection therewith, 180 filed a Certificate of Amendment of its Certificate of
Incorporation in Delaware to change its name to 180 Life Corp., and KBL changed
its name to 180 Life Sciences Corp.



Following the closing of the Business Combination, we transitioned our
operations to those of 180, which is a clinical stage biotechnology company
headquartered in Palo Alto, California, focused on the development of
therapeutics for unmet medical needs in chronic pain, inflammation, fibrosis and
other inflammatory diseases, where anti-TNF therapy will provide a clear benefit
to patients, by employing innovative research, and, where appropriate,
combination therapy. We have three product development platforms:



  ? fibrosis and anti-tumor necrosis factor ("TNF");




  ? drugs which are derivatives of cannabidiol ("CBD"); and




  ? alpha 7 nicotinic acetylcholine receptor ("?7nAChR").




                                       27





We have several future product candidates in development, including one product
candidate which has recently completed a successful Phase 2b clinical trial in
the United Kingdom for Dupuytren's Contracture, a condition that affects the
development of fibrous connective tissue in the palm of the hand. 180 was
founded by several world-leading scientists in the biotechnology and
pharmaceutical sectors.



We intend to invest resources to successfully complete the clinical programs
that are underway, discover new drug candidates, and develop new molecules to
build on our existing pipeline to address unmet clinical needs. The product
candidates are designed via a platform comprised of defined unit operations and
technologies. This work is performed in a research and development environment
that evaluates and assesses variability in each step of the process in order to
define the most reliable production conditions.



We may rely on third-party contract manufacturing organizations ("CMOs") and
other third parties for the manufacturing and processing of the product
candidates in the future. We believe the use of contract manufacturing and
testing for the first clinical product candidates is cost-effective and has
allowed us to rapidly prepare for clinical trials in accordance with our
development plans. We expect that third-party manufacturers will be capable of
providing and processing sufficient quantities of these product candidates to
meet anticipated clinical trial demands.



July 2022 Offering



On July 17, 2022, the Company entered into a Securities Purchase Agreement with
certain purchasers, pursuant to which the Company agreed to sell an aggregate of
3,500,000 shares of common stock, pre-funded warrants to purchase up to an
aggregate of 2,632,076 shares of common stock ("July 2022 Pre-Funded Warrants"),
and common stock warrants to purchase up to an aggregate of 6,132,076 shares of
common stock (the "July 2022 Common Warrants"), at a combined purchase price of
$1.06 per share and warrant (the "July 2022 Offering"). Aggregate gross proceeds
from the July 2022 Offering were $6,499,737. The July 2022 Offering closed

on
July 20, 2022.



The July 2022 Pre-Funded Warrants have an exercise price equal to $0.0001, are
immediately exercisable and are subject to customary anti-dilution adjustments
for stock splits or dividends or other similar transactions. The exercise price
of the July 2022 Pre-Funded Warrants will not be subject to adjustment as a
result of subsequent equity issuances at effective prices lower than the
then-current exercise price. The July 2022 Pre-Funded Warrants are exercisable
until they are exercised in full. The July 2022 Pre-Funded Warrants are subject
to a provision prohibiting the exercise of such July 2022 Pre-Funded Warrants to
the extent that, after giving effect to such exercise, the holder of such July
2022 Pre-Funded Warrants (together with the holder's affiliates, and any other
persons acting as a group together with the holder or any of the holder's
affiliates), would beneficially own in excess of 9.99% of the Company's
outstanding common stock (which may be increased or decreased, with 61 days
prior written notice by the holder). Although the July 2022 Pre-Funded Warrants
have a tender offer provision, the July 2022 Pre-Funded Warrants were determined
to be equity-classified because they met the limited exception in the case of a
change-in-control. Because the July 2022 Pre-Funded Warrants are
equity-classified, the placement agent fees and offering expenses will be
accounted for as a reduction of additional paid in capital.



                                       28





The July 2022 Common Warrants have an exercise price equal to $1.06 per share,
are exercisable 6 months following the closing of the July 2022 Offering (the
"Initial Exercise Date") and are subject to customary anti-dilution adjustments
for stock splits or dividends or other similar transactions. The exercise price
of the July 2022 Common Warrants will not be subject to adjustment as a result
of subsequent equity issuances at effective prices lower than the then-current
exercise price. The July 2022 Common Warrants are exercisable for 5 years
following the Initial Exercise Date. The July 2022 Common Warrants are subject
to a provision prohibiting the exercise of such July 2022 Common Warrants to the
extent that, after giving effect to such exercise, the holder of such July 2022
Common Warrants (together with the holder's affiliates, and any other persons
acting as a group together with the holder or any of the holder's affiliates),
would beneficially own in excess of 4.99% of the Company's outstanding common
stock (which may be increased or decreased, with 61 days prior written notice by
the holder). Although the July 2022 Common Warrants have a tender offer
provision, the July 2022 Common Warrants were determined to be equity-classified
because they met the limited exception in the case of a change-in-control.
Because the July 2022 Common Warrants are equity-classified, the placement agent
fees and offering expenses will be accounted for as a reduction of additional
paid in capital.



COVID-19 Pandemic



On March 11, 2020, the World Health Organization declared COVID-19 a pandemic.
The global spread and impact of COVID-19 has created significant volatility,
uncertainty and economic disruption. The extent of COVID-19's effect on the
Company's operational and financial performance will depend on future
developments, including the duration, spread and intensity of the pandemic
(including any resurgences), the impact of variants of the virus that
causes COVID-19, the wide distribution and public acceptance of COVID-19
vaccines, labor needs at the Company as well as in the supply chain, compliance
with government or employer COVID-19 vaccine mandates and the resulting impact
on available labor, and the level of social and economic restrictions imposed in
the United States and abroad in an effort to curb the spread of the virus, all
of which are uncertain and difficult to predict. As a result, it is not
currently possible to ascertain the overall impact of COVID-19 on the Company's
business, results of operations, financial condition or liquidity. While the
ultimate health and economic impact of COVID-19 continues to be highly
uncertain, the Company does not currently expect an adverse impact on its
business related to of COVID-19. Future events and effects related to
the COVID-19 pandemic cannot be determined with precision and actual results
could significantly differ from estimates or forecasts.



The follow up time for patient data and the statistical analysis for the Phase
2b Dupuytren's Contracture clinical trial was delayed as a result of COVID-19,
but such follow-up and statistical analysis are now completed and the Company
announced the top-line data results from the Phase 2b trial on December 1, 2021
and the data was published on April 29, 2022 in a peer-reviewed journal.
Additionally, COVID-19 has delayed the initiation of certain clinical trials and
may delay the initiation of other clinical trials in the future or otherwise
have a material adverse effect on our future operations.



                                       29




Significant Financial Statement Components





Research and Development



To date, 180's research and development expenses have related primarily to
discovery efforts and preclinical and clinical development of its three product
platforms: fibrosis and anti-TNF; drugs which are derivatives of CBD, and
?7nAChR. Research and development expenses consist primarily of costs associated
with those three product platforms, which include:



? expenses incurred under agreements with 180's collaboration partners and

third-party contract organizations, investigative clinical trial sites that

conduct research and development activities on its behalf, and consultants;

? costs related to production of clinical materials, including fees paid to


    contract manufacturers;



? laboratory and vendor expenses related to the execution of preclinical and


    clinical trials;



? employee-related expenses, which include salaries, benefits and stock-based


    compensation; and



? facilities and other expenses, which include expenses for rent and maintenance

of facilities, depreciation and amortization expense and other supplies.


We expense all research and development costs in the periods in which they are
incurred. We accrue for costs incurred as services are provided by monitoring
the status of each project and the invoices received from our external service
providers. We adjust our accrual as actual costs become known. When contingent
milestone payments are owed to third parties under research and development
arrangements or license agreements, the milestone payment obligations are
expensed when the milestone results are achieved.



Research and development activities are central to our business model. Product
candidates in later stages of clinical development generally have higher
development costs than those in earlier stages of clinical development,
primarily due to the increased size and duration of later-stage clinical trials.
We expect that research and development expenses will increase over the next
several years as clinical programs progress and as we seek to initiate clinical
trials of additional product candidates. It is also expected that increased
research and development expenses will be incurred as additional product
candidates are selectively identified and developed. However, it is difficult to
determine with certainty the duration and completion costs of current or future
preclinical programs and clinical trials of product candidates.



The duration, costs and timing of clinical trials and development of product
candidates will depend on a variety of factors that include, but are not limited
to, the following:



  ? per patient trial costs;




  ? the number of patients that participate in the trials;




  ? the number of sites included in the trials;




  ? the countries in which the trials are conducted;




  ? the length of time required to enroll eligible patients;




  ? the number of doses that patients receive;




  ? the drop-out or discontinuation rates of patients;




  ? potential additional safety monitoring or other studies requested by
    regulatory agencies;




  ? the impact of COVID-19 on the length of our trials;




  ? the duration of patient follow-up; and




  ? the efficacy and safety profile of the product candidates.




                                       30





In addition, the probability of success for each product candidate will depend
on numerous factors, including competition, manufacturing capability and
commercial viability. We will determine which programs to pursue and fund in
response to the scientific and clinical success of each product candidate, as
well as an assessment of each product candidate's commercial potential.



Because the product candidates are still in clinical and preclinical development
and the outcome of these efforts is uncertain, we cannot estimate the actual
amounts necessary to successfully complete the development and commercialization
of product candidates or whether, or when, we may achieve profitability. Due to
the early-stage nature of these programs, we do not track costs on a
project-by-project basis. As these programs become more advanced, we intend to
track the external and internal cost of each program.



General and Administrative


General and administrative expenses consist primarily of salaries and other staff-related costs, including stock-based compensation for shares of common stock issued and options granted to founders, directors and personnel in executive, commercial, finance, accounting, legal, investor relations, facilities, business development and human resources functions and include vesting conditions.





Other significant general and administrative costs include costs relating to
facilities and overhead costs, legal fees relating to corporate and patent
matters, litigation, SEC filings, insurance, investor relations costs, fees for
accounting and consulting services, and other general and administrative costs.
General and administrative costs are expensed as incurred, and we accrue amounts
for services provided by third parties related to the above expenses by
monitoring the status of services provided and receiving estimates from our
service providers and adjusting our accruals as actual costs become known.



It is expected that the general and administrative expenses will increase over
the next several years to support our continued research and development
activities, manufacturing activities, potential commercialization of our product
candidates and the increased costs of operating as a public company. These
increases are anticipated to include increased costs related to the hiring of
additional personnel, developing commercial infrastructure, fees to outside
consultants, lawyers and accountants, and increased costs associated with being
a public company, as well as expenses related to services associated with
maintaining compliance with Nasdaq listing rules and SEC requirements, insurance
and investor relations costs.



Interest Expense


Interest expense consists primarily of interest expense related to debt instruments.

Gain (Loss) on Extinguishment of Convertible Notes

Gain (loss) on extinguishment of convertible notes represents the shortfall (excess) of the reacquisition cost of convertible notes as compared to their carrying value.





                                       31




Change in Fair Value of Derivative Liabilities





Change in fair value of derivative liabilities represents the non-cash change in
fair value of derivative liabilities during the reporting period. Gains
resulting from change in fair value of derivative liabilities during the three
and nine months ended September 30, 2022, were driven by decreases in stock
price during the periods, resulting in a lower fair value of the underlying
liability.



Offering Costs Allocated to Warrant Liabilities





Change in offering costs allocated to warrant liabilities represents placement
agent fees and offering expenses which were allocated to the February 2021 PIPE
Warrants and expensed immediately as they are liability classified.



Change in Fair Value of Accrued Issuable Equity

Change in fair value of accrued issuable equity represents the non-cash change in fair value of accrued equity prior to its formal issuance.

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