Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Form 10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: September
30, 2022
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ____________ to ______________
Commission File Number: 001-41282
SUNSHINE BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
Colorado
20-5566275
(State of other jurisdiction of incorporation)
(IRS Employer ID No.)
6500 Trans-Canada Highway
4th Floor
Pointe-Claire , Quebec , Canada H9R 0A5
(Address of principal executive offices)
(514) 426-6161
(Issuer’s Telephone Number)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Trading Symbol
Name of Each Exchange on Which Registered
Common Stock
Common Stock Purchase Warrants
SBFM
SBFMW
The NASDAQ Stock Market LLC
The NASDAQ Stock Market LLC
Indicate by check mark whether the registrant (1)
has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days: Yes ☒ No ☐
Indicate by check mark whether the registrant has
submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant is a
large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See
the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company”, and
“emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one)
Large accelerated filer ☐
Accelerated filer ☐
Non-accelerated filer ☒
Smaller reporting company ☒
Emerging growth company ☐
If an emerging growth company, indicate by check mark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is
a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐
Yes ☒ No
The number of shares of the registrant’s common
stock, par value $0.001, issued and outstanding as of November 7, 2022, was 22,585,632 shares.
TABLE OF CONTENTS
Page No
PART I. FINANCIAL INFORMATION
Item 1.
Financial Statements
2
Condensed Consolidated Balance Sheets as of September 30, 2022 (Unaudited) and December 31, 2021
2
Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2022 and 2021 (Unaudited)
3
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended
September 30, 2022 and 2021 (Unaudited)
4
Condensed Consolidated Statement of Shareholders' Equity (Unaudited)
5
Notes to Unaudited Condensed Consolidated Financial Statements
6
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
12
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
18
Item 4.
Controls and Procedures
18
PART II. OTHER INFORMATION
Item 1.
Legal Proceedings
19
Item 1A.
Risk Factors
19
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
19
Item 3.
Defaults Upon Senior Securities
19
Item 4.
Mine Safety Disclosures
19
Item 5.
Other Information
19
Item 6.
Exhibits
19
Signatures
20
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
Sunshine Biopharma, Inc.
Condensed Consolidated Balance Sheets
September 30,
December 31,
2022
2021
Unaudited
ASSETS
Current Assets:
Cash and cash equivalents
$ 40,555,931
$ 2,045,167
Accounts receivable
22
7,798
Inventory
269,641
105,650
Prepaid expenses
27,390
29,625
Deposits
7,590
7,590
Total Current Assets
40,860,574
2,195,830
Equipment, net
3,770
7,061
TOTAL ASSETS
$ 40,864,344
$ 2,202,891
LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities:
Accounts payable and accrued expenses
$ 480,209
$ 42,942
Interest payable
–
48,287
Total Current Liabilities
480,209
91,229
Long-term portion of notes payable
–
1,900,000
TOTAL LIABILITIES
480,209
1,991,229
SHAREHOLDERS' EQUITY
Preferred Stock, Series B $ 0.10
par value per share; 1,000,000
shares authorized; 10,000
and 1,000,000
shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively
1,000
100,000
Common Stock, $ 0.001
par value per share; 3,000,000,000
shares authorized; 18,885,632
and 2,591,240
shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively
18,886
2,591
Capital paid in excess of par value
76,331,451
32,787,384
Accumulated comprehensive (loss)
( 79,903 )
( 23,139 )
Accumulated (deficit)
( 35,887,299 )
( 32,655,174 )
TOTAL SHAREHOLDERS' EQUITY
40,384,135
211,662
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
$ 40,864,344
$ 2,202,891
See Accompanying Notes.
3
Sunshine Biopharma, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
3 Months Ended
9 Months Ended
September 30,
September 30,
September 30,
September 30,
2022
2021
2022
2021
.
.
Revenues
$ 132,808
$ 50,376
$ 405,760
$ 143,308
Cost of sales
65,783
19,506
200,311
56,541
Gross profit
67,025
30,870
205,449
86,767
General and Administrative Expenses:
Accounting
122,913
35,000
237,773
96,200
Advertising and Marketing
217,666
–
400,386
–
Consulting
162,852
20,598
270,033
53,168
Legal
142,883
56,923
388,238
159,074
Office
76,818
58,959
449,730
159,762
Officer and director remuneration
695,000
130,000
1,305,000
1,173,927
Patent fees
3,584
1
15,148
14,571
R&D
362,500
222,465
770,095
581,011
Depreciation
789
3,183
6,186
9,557
Total General and Administrative Expenses
1,785,005
527,129
3,842,589
2,247,270
(Loss) from operations
( 1,717,980 )
( 496,259 )
( 3,637,140 )
( 2,160,503 )
Other Income (Expense):
Foreign exchange gain
25
37
45
31
Interest income
260,938
–
406,984
–
Interest expense
( 2 )
( 46,849 )
( 12,866 )
( 292,188 )
Debt forgiveness
–
7,688
10,852
58,940
Loss on debt conversions
–
( 3,504,000 )
–
( 10,709,843 )
Total Other Income (Expense)
260,961
( 3,543,124 )
405,015
( 10,943,060 )
Net (loss) before income taxes
( 1,457,019 )
( 4,039,383 )
( 3,232,125 )
( 13,103,563 )
Provision for income taxes
–
–
–
–
Net (Loss)
$ ( 1,457,019 )
$ ( 4,039,383 )
$ ( 3,232,125 )
$ ( 13,103,563 )
(Loss) from foreign exchange translation
( 45,126 )
( 5,839 )
( 56,764 )
( 14,604 )
Comprehensive (Loss)
$ ( 1,502,145 )
$ ( 4,045,222 )
$ ( 3,288,889 )
$ ( 13,118,167 )
Basic (loss) per common share
$ ( 0.08 )
$ ( 1.59 )
$ ( 0.26 )
$ ( 5.73 )
Weighted Average Common Shares Outstanding (Basic)
18,885,632
2,542,640
12,789,733
2,287,682
See Accompanying Notes.
4
Sunshine Biopharma, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
9 Months Ended
September 30,
September 30,
2022
2021
Cash Flows From Operating Activities:
Net (Loss)
$ ( 3,232,125 )
$ ( 13,103,563 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
6,186
9,557
Foreign exchange (gain) loss
45
( 31 )
Stock issued for services
–
918,000
Stock issued for payment interest
–
38,201
Loss on debt conversion
–
10,709,843
Debt forgiveness
( 10,852 )
( 58,940 )
Decrease in accounts receivable
7,776
787
(Increase) in inventory
( 163,991 )
( 47,539 )
(Increase) decrease in prepaid expenses
2,235
( 22,268 )
Increase (decrease) in Accounts Payable & accrued expenses
437,267
( 13,778 )
Increase (decrease) in interest payable
( 48,287 )
52,716
Net Cash Flows (Used) in Operations
( 3,001,746 )
( 1,517,015 )
Cash Flows From Financing Activities:
Proceeds public offerings, net
43,560,363
3,318,500
Purchase of preferred shares
( 99,000 )
61,500
Payments of notes payable
( 1,900,000 )
( 451,661 )
Net Cash Flows Provided by Financing Activities
41,561,363
2,928,339
Cash and Cash Equivalents at Beginning of Period
2,045,167
989,888
Net increase in cash and cash equivalents
38,559,617
1,411,324
Effect of exchange rate changes on cash
( 105,617 )
–
Foreign currency translation adjustment
56,764
( 14,604 )
Cash and Cash Equivalents at End of Period
$ 40,555,931
$ 2,386,608
Supplementary Disclosure of Cash Flow Information:
Stock issued for note conversions including interest
$ –
$ 11,981,072
Cash paid for interest
$ 61,151
$ 155,081
Cash paid for income taxes
$ –
$ –
See Accompanying Notes.
5
Sunshine Biopharma, Inc.
Condensed Consolidated Statement of Shareholders' Equity (Unaudited)
Number Of Common
Capital Paid in Excess
Number Of Preferred
Shares
Common
of Par
Shares
Preferred
Comprehensive
Accumulated
Issued
Stock
Value
Issued
Stock
Income
Deficit
Total
Three Month Period
Balance at June 30, 2022
18,885,632
$ 18,886
$ 76,331,451
10,000
$ 1,000
$ ( 34,777 )
$ ( 34,430,280 )
$ 41,886,280
Net (loss)
–
–
–
–
–
( 45,126 )
( 1,457,019 )
( 1,502,145 )
Balance at September 30, 2022
18,885,632
$ 18,886
$ 76,331,451
10,000
1,000
$ ( 79,903 )
$ ( 35,887,299 )
40,384,135
Nine Month Period
Balance December 31, 2021
2,595,620
$ 2,596
$ 32,787,379
1,000,000
$ 100,000
$ ( 23,139 )
$ ( 32,655,174 )
$ 211,662
Common stock and pre-funded warrants
issued in an underwritten public and private offerings, net of issuance costs
6,656,526
6,657
30,360,528
–
–
–
–
30,367,185
Exercise of warrants
9,633,486
9,633
13,183,544
–
–
–
–
13,193,177
Preferred stock purchased from related party
–
–
–
( 990,000 )
( 99,000 )
–
–
( 99,000 )
Net (loss)
–
–
–
–
–
( 56,764 )
( 3,232,125 )
( 3,288,889 )
Balance at September 30, 2022
18,885,632
$ 18,886
$ 76,331,451
10,000
$ 1,000
$ ( 79,903 )
$ ( 35,887,299 )
$ 40,384,135
Three Month Period
Balance June 30, 2021
2,430,466
$ 2,430
$ 28,319,403
1,000,000
$ 100,000
$ ( 11,636 )
$ ( 29,282,907 )
$ ( 872,710 )
Common stock issued for the reduction of notes payable and payment of interest
120,000
120
3,743,880
–
–
–
–
3,744,000
Net (loss)
–
–
–
–
–
( 5,839 )
( 4,039,383 )
( 4,045,222 )
Balance at September 30, 2021
2,550,466
$ 2,550
$ 32,063,283
1,000,000
$ 100,000
$ ( 17,475 )
$ ( 33,322,290 )
$ ( 1,173,932 )
Nine Month Period
Balance December 31, 2020
1,732,096
$ 1,732
$ 19,165,029
1,000,000
$ 100,000
$ ( 2,871 )
$ ( 20,218,727 )
$ ( 954,837 )
Common stock issued for the reduction of note payable and payment
of interest
518,370
518
11,980,554
–
–
–
–
11,981,072
Common stock issued for services
300,000
300
917,700
–
–
–
–
918,000
Net (loss)
–
–
–
–
–
( 14,604 )
( 13,103,563 )
( 13,118,167 )
Balance at September 30, 2021 (unaudited)
2,550,466
$ 2,550
$ 32,063,283
1,000,000
$ 100,000
$ ( 17,475 )
$ ( 33,322,290 )
$ ( 1,173,932 )
See Accompanying Notes.
6
Sunshine Biopharma, Inc.
Notes to Unaudited Condensed
Consolidated Financial Statements
For the Three and Nine Month Interim Periods
Ended September 30, 2022 and 2021
Note 1
– Nature of Business
Sunshine Biopharma,
Inc. (the “Company”) was originally incorporated under the name Mountain West Business Solutions, Inc. on August 31, 2006,
in the State of Colorado. Until October 2009, the Company was operating as a business consultancy firm.
Effective October
15, 2009, the Company acquired Sunshine Biopharma, Inc. in a transaction classified as a reverse acquisition. Sunshine Biopharma, Inc.
held an exclusive license to a new anticancer drug bearing the laboratory name, Adva-27a (the “License Agreement”). Upon completion
of the reverse acquisition transaction, the Company changed its name to Sunshine Biopharma, Inc. and began operating as a pharmaceutical
company focusing on the development of the licensed Adva-27a anticancer drug.
In December
2015, the Company acquired all issued (US Patent Number 8,236,935, and 10,272,065) and pending patents under PCT/FR2007/000697 and PCT/CA2014/000029
for the Adva-27a anticancer compound from Advanomics Corporation, a related party, and terminated the License Agreement. In 2016, the
remaining value of these patents was impaired. The Company is however continuing development of the Adva-27a anticancer drug covered by
these patents.
In December
2018, the Company launched a Science-Based Nutritional Supplements product, Essential 9 ™ ,
an over-the-counter capsule comprised of the nine (9) essential amino acids that the human body cannot make. Essential 9 ™ has
been authorized for marketing by Health Canada under NPN 80089663.
On May 22, 2020,
the Company filed a provisional patent application in the United States for a new treatment for Coronavirus infections. The Company’s
patent application covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro,
an enzyme that is essential for viral replication. The patent application has a priority date of May 22, 2020. On April 30, 2021, the
Company filed a PCT application containing new research results and extending coverage to include the Coronavirus Papain-Like protease,
PLpro. The priority date of May 22, 2020 has been maintained in the newly filed PCT application. The Company’s lead Anti-Coronavirus
compound arising from these patents bears the laboratory name SBFM-PL4.
On January 26,
2021, the Company received a Notice of Allowances from the Canadian Intellectual Property Office for a new patent application covering
Adva-27a. The newly issued patent contains new subject matter and extends the proprietary protection of Adva-27a in Canada until 2033.
On March 9,
2021, the Company received a Notice of Allowance from the European Patent Office for a new patent application covering Adva-27a. The newly
issued patent contains new subject matter and extends the proprietary protection of Adva-27a in Europe until 2033. The equivalent patent
in the United States was issued in 2019 (US Patent Number 10,272,065).
On
February 15, 2022, the Company entered into an underwriting agreement with Aegis Capital Corp. as underwriter, for the issuance and
sale in an underwritten public offering of 1,882,353 Units, each consisting of one share of common stock and two warrants
(“Tradeable Warrants”) to purchase shares of common stock at a public offering price of $4.25 per Unit for total gross
proceeds of $8,000,000 (“Public Offering”). On February 17, 2022, the Public Offering closed and the Company received
net proceeds of $ 6,833,071 .
Pursuant to the Public Offering, the Company issued and sold an aggregate of 1,882,353 shares
of common stock and 4,102,200
Tradeable Warrants (including 337,494 Tradeable Warrants purchased at $0.01 per warrant resulting from partial exercise of the
overallotment option granted to the underwriter). In connection with these transactions, the Company’s shares of common stock
and Tradeable Warrants began trading on Nasdaq under the symbol “SBFM” for the common stock and “SBFMW” for
the Tradeable Warrants.
7
On February
18, 2022, the Company entered into a research agreement (the “SRA”) with the University of Arizona for the purposes of conducting
research focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of three University of Arizona owned
PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research Project”). Under the
SRA, the University of Arizona granted the Company a first option to negotiate a commercial, royalty-bearing license for all intellectual
property developed by University of Arizona personnel under the Research Project. In addition, the Company and the University of Arizona
entered into an Option Agreement whereby the Company was granted a first option to negotiate a royalty-bearing commercial license for
the underlying technology of the Research Project. Intending to move forward with the technology, the Company submitted a Notice of Option
Exercise to the University of Arizona on September 13, 2022.
On
February 22, 2022, the Company redeemed 990,000
shares of the Series B Preferred Stock from the CEO of the Company at a redemption price equal to the stated value of $0.10
per share.
On March 14,
2022, the Company completed a private placement wherein the Company sold (i) 2,301,353 shares
of its common stock together with warrants (the “Investor Warrants”) to purchase up to 2,301,353
shares of common stock, and (ii) 1,302,251 pre-funded
warrants (“Pre-Funded Warrants”) with each Pre-Funded Warrant exercisable for one share of common stock, together with Investor
Warrants to purchase up to 1,302,251 shares of common stock. Each share of common stock and accompanying Investor Warrant were sold together
at a combined offering price of $2.22, and each Pre-Funded Warrant and accompanying Investor Warrant were sold together at a combined
offering price of $2.219. The Company received approximately $8 million in gross proceeds, and $ 6,781,199 in
net proceeds in this offering.
On April 28,
2022, the Company completed another private placement and received net proceeds of $ 16,752,915 .
In connection with this private placement, the Company issued (i) 2,472,820 shares
of its common stock together with warrants (“April Warrants”) to purchase up to 4,945,640
shares of common stock, and (ii) 2,390,025
pre-funded warrants (“Pre-Funded Warrants”) with each Pre-Funded Warrant
exercisable for one share of common stock, together with April Warrants to purchase up to 4,780,050 shares of common stock. Each share
of common stock and accompanying two April Warrants were sold together at a combined offering price of $4.01, and each Pre-Funded Warrant
and accompanying two April Warrants were sold together at a combined offering price of $4.01, and each Pre-Funded Warrant and accompanying
two April Warrants were sold together at a combined offering price of $4.009. The Pre-Funded Warrants were immediately exercisable, at
a nominal exercise price of $0.001, and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. The
April Warrants have an exercise price of $ 3.76
per share (subject to adjustment as set forth in the warrant), are exercisable upon
issuance and will expire five years from the date of issuance.
On October 20, 2022, the Company acquired Nora Pharma Inc. (“Nora
Pharma”), a Canadian generic pharmaceuticals company. Based in the greater Montreal area, Nora Pharma has 36 employees and operates
in a 15,000 square foot facility certified by Health Canada. Nora Pharma currently offers over 50 pharmaceutical products, including generic
prescription drugs, over-the-counter products and biosimilars. Nora Pharma sales were $10.7 million (USD) during its fiscal year ended
June 30, 2022.
Note 2
– Basis of Presentation
The unaudited financial statements
of the Company for the nine month periods ended September 30, 2022 and 2021 have been prepared in accordance with accounting principles
generally accepted in the United States of America for interim financial information and pursuant to the requirements for reporting on
Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by accounting principles generally
accepted in the United States of America for complete financial statements. However, such information reflects all adjustments (consisting
solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the financial
position and the results of operations. Results shown for interim periods are not necessarily indicative of the results to be obtained
for a full fiscal year. The balance sheet information as of December 31, 2021 was derived from the audited financial statements included
in the Company's financial statements as of and for the year ended December 31, 2021 included in the Company’s Annual Report on
Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 21, 2022. These financial statements should
be read in conjunction with that report.
Note 3
– Impact of Coronavirus (COVID-19) Pandemic
In March 2020,
the World Health Organization declared Coronavirus and its associated disease, COVID-19, a global pandemic. Conditions surrounding the
Coronavirus outbreak have been and are continuing to evolve rapidly. Government authorities in the U.S. and around the world have implemented
emergency measures to mitigate the spread of the virus. The outbreak and related mitigation measures have had and will continue to have
a material adverse impact on the world economies and the Company's business activities. It is not possible for the Company to predict
the duration or magnitude of the adverse conditions of the outbreak and their effects on the Company’s business or ability to raise
funds. No adjustments have been made to the amounts reported in the Company's financial statements as a result of this matter.
8
Note 4 – Reverse
Stock Splits
Effective February
1, 2019, the Company completed a 20 to 1 reverse split of its common stock (the “First Reverse Stock Split”).
Effective April
6, 2020, the Company completed another 20 to 1 reverse split of its common stock (the “Second Reverse Stock Split”).
Effective February
9, 2022, the Company completed a 1 for 200 reverse split of its common stock (the “Third Reverse Stock Split”).
The Company's
financial statements reflect the First, Second, and Third Reverse Stock Split on a retroactive basis for all periods presented and for
all references to common stock, unless specifically stated otherwise.
Note 5
– Notes Payable
As of September
30, 2022 and December 31, 2021, the Company had $ 0 and $ 1,900,000 , respectively in notes payable outstanding. At September 30, 2022
and December 31, 2021, total accrued interest on Notes Payable was $ 0 and $ 48,287 , respectively.
The Company’s
Notes Payable at December 31, 2021 consisted of the following:
On April 20,
2021, the Company received monies in exchange for a Note Payable having a Face Value of $ 500,000
with interest accruing at 5 %
due April
20, 2023 . The Note was convertible after 180 days from issuance into common stock
at a price equal to $0.30 per share. On February 17, 2022, the Company paid off the entire principal balance of this Note, together with
accrued interest of $ 20,753
by making cash payment of $ 520,753 .
On July 6, 2021,
the Company received monies in exchange for a Note Payable having a Face Value of $ 900,000 with interest accruing at 5 %, due July
6, 2023 . The Note was convertible after 180 days from issuance into common stock at a price equal to $0.30 per share. On February 17,
2022, the Company paid off the entire principal balance of this Note, together with accrued interest of $ 27,863 by making cash payment
of $ 927,863 .
On August
18, 2021, the Company received monies in exchange for a Note Payable having a Face Value of $ 500,000
with interest accruing at 5 %,
due August
18, 2023 . The Note was convertible after 180 days from issuance into common stock at a price equal to $0.30 per share. On
February 17, 2022, the Company paid off the entire principal balance of this Note, together with accrued of $ 12,534 by
making cash payment of $ 512,534 .
Note 6
– Shareholders’ Equity
On February
17, 2022, the Company’s Public Offering closed and the Company received net proceeds of $ 6,833,071
from the offering. Pursuant to the Public Offering, the Company issued and sold an
aggregate of 1,882,353 shares of common stock and 4,102,200 Tradeable Warrants (including 337,494 Tradeable Warrants resulting from partial
exercise of the overallotment option granted to the underwriter).
On
February 22, 2022, the Company redeemed 990,000
shares of Series B Preferred Stock from the CEO of the Company at a redemption price equal to the stated value of $ 0.10
per share.
On March 14,
2022, the Company completed a private placement and received net proceeds of $ 6,781,199 . In connection with this private placement, the
Company issued (i) 2,301,353 shares of its common stock together with investor warrants (“Investor Warrants”) to
purchase up to 2,301,353 shares of common stock, and (ii) 1,302,251 pre-funded warrants (“Pre-Funded Warrants”)
with each Pre-Funded Warrant exercisable for one share of common stock, together with Investor Warrants to purchase up to 1,302,251 shares
of common stock. Each share of common stock and accompanying Investor Warrant were sold together at a combined offering price of $2.22
and each Pre-Funded Warrant and accompanying Investor Warrant were sold together at a combined offering price of $2.219. The Pre-Funded
Warrants were immediately exercisable, at a nominal exercise price of $0.001, and may be exercised at any time until all of the Pre-Funded
Warrants are exercised in full. The Investor Warrants have an exercise price of $2.22 per share (subject to adjustment as set forth in
the warrant), are exercisable upon issuance and will expire five years from the date of issuance.
9
On April 28,
2022, the Company completed another private placement and received net proceeds of $ 16,752,915 . In connection with this private placement,
the Company issued (i) 2,472,820 shares of its common stock together with warrants (“April Warrants”) to purchase
up to 4,945,640 shares of common stock, and (ii) 2,390,025 pre-funded warrants (“Pre-Funded Warrants”)
with each Pre-Funded Warrant exercisable for one share of common stock, together with April Warrants to purchase up to 4,780,050 shares
of common stock. Each share of common stock and accompanying two April Warrants were sold together at a combined offering price of $4.01
and each Pre-Funded Warrant and accompanying two April Warrants were sold together at a combined offering price of $4.009. The Pre-Funded
Warrants were immediately exercisable, at a nominal exercise price of $0.001, and may be exercised at any time until all of the Pre-Funded
Warrants are exercised in full. The April Warrants have an exercise price of $ 3.76 per share (subject to adjustment as set forth
in the warrant), are exercisable upon issuance and will expire five years from the date of issuance.
The
Company declared no
dividends through September 30, 2022.
Note 7 – Warrants
The
Company accounts for issued warrants either as a liability or equity in accordance with ASC 480-10 or ASC 815-40. Under ASC 480-10, warrants
are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number
of shares. If warrants do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to
determine whether the warrants should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement
for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured
at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance
date is recorded in the consolidated statements of operations as a gain or loss. If warrants do not require liability classification under
ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its
common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Equity-classified warrants
are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.
During
the nine months ended September 30, 2022, the Company completed three financing events, and in connection therewith, it issued warrants
as follows:
Warrants issued with financing
TYPE
NUMBER
EXERCISE PRICE
EXPIRY DATE
Pre-Funded Warrants
3,692,276
$ 0.001
Unlimited
Tradeable Warrants
4,102,200
$ 2.22 *
February 2027
Investor Warrants
3,603,604
$ 2.22
March 2027
April Warrants
9,725,690
$ 3.76
April 2027
*
The Tradeable
Warrants had an initial exercise price of $4.25, subject to adjustment. Upon the closing of the Company’s private placement
on March 14, 2022, the exercise price of the Tradeable Warrants was reduced to $2.22, in accordance with the terms thereof.
During the
nine months ended September 30, 2022, all of the Pre-Funded Warrants and a total of 3,138,507 Tradeable
Warrants were exercised resulting in aggregate proceeds of $ 6,971,178 received
by the Company. In addition, during the nine months ended September 30, 2022, a total of 2,802,703 Investor
Warrants were exercised resulting in aggregate proceeds of $ 6,222,001 received
by the Company.
The Company’s outstanding warrants
at September 30, 2022 consisted of the following:
Schedule of outstanding warrants
TYPE
NUMBER
EXERCISE PRICE
EXPIRY DATE
Pre-Funded Warrants
None
$ 0.001
Unlimited
Tradeable Warrants
963,693
$ 2.22
February 2027
Investor Warrants
800,901
$ 2.22
March 2027
April Warrants
9,725,690
$ 3.76
April 2027
10
Note 8
– Net Loss Per Common Share
Basic net loss
per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period,
without consideration for common stock equivalents.
Diluted net
loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the
period, taking into consideration common stock equivalents.
In
February 2022, the Company issued 4,102,200 Tradeable
Warrants pursuant to the Company’s Public Offering. In March and April 2022, the Company issued 3,603,604 Investor
Warrants and 9,725,690 April
Warrants pursuant to two private placements. As of September 30, 2022, 3,138,507 Tradeable
Warrants, 2,802,703 Investor
Warrants, and - 0 -
April Warrants were exercised, leaving 963,693 Tradeable
Warrants, 800,901 Investor
Warrants and 9,725,690 April
Warrants outstanding. These warrants are dilutive and were included in the diluted earnings per share.
In March and
April 2022, the Company issued and sold Pre-Funded Warrants to purchase an aggregate of 3,692,276 shares of common stock at a nominal
exercise price of $0.001 per share (see Note 3). During the nine months ended September 30, 2022, all of these warrants were exercised
and therefore had no remaining dilutive effect.
Note 9
– Management and Director Compensation
The
Company paid its officers cash compensation totaling $ 595,000 and
$ 105,000 and
$ 1,095,000 and
$ 130,000 for
the three and nine month periods ended September 30, 2022 and 2021, respectively. Of these amounts attributable to the
Company’s CEO, as of September 30, 2021 $ 110,000
was paid to Advanomics Corporation, a company controlled by the CEO of the Company. In addition, the Company issued 300,000 shares
of common stock valued at $ 918,000 to
its officers during the three months ended September 30, 2021. The value of these shares was based upon the closing price of the
Company’s common stock of $3.06 on the issuance date.
The Company
paid its directors cash compensation totaling $ 100,000 and $ 200,000 for the three and nine month periods ended September 30, 2022
and 2021, respectively.
Note 10
– Subsequent Events
On October 20, 2022, the Company acquired all of the outstanding shares
of Nora Pharma Inc., a Canadian generic pharmaceuticals company. The total purchase price of $30,000,000 Canadian (approximately $21,900,000
USD) was paid by paying $20,000,000 Canadian (approximately $14,600,000 USD) in cash, issuing 3,700,000 shares of the Company’s
Common Stock valued at $5,000,000 Canadian (approximately $3,650,000 USD), and $5,000,000 Canadian (approximately $3,650,000 USD) which
may be paid in the future as an earn-out amount based on target sales. Through the contingent earn-out, the seller, Mr. Malek Chamoun,
has the opportunity to earn up to $5,000,000 CAD (approximately $3,650,000 USD) in the form of twenty (20) payments of $250,000 CAD for
every $1,000,000 CAD increase in gross sales above Nora Pharma’s June 30, 2022 gross sales, provided that his employment with the
Company is not terminated pursuant to the Company’s Employment Agreement with him.
11
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations.
The following discussion should
be read in conjunction with our consolidated financial statements and notes thereto included herein. This discussion includes forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the
Securities Exchange Act of 1934, as amended, or the Exchange Act. The statements regarding Sunshine Biopharma, Inc. contained in this
Report that are not historical in nature, particularly those that utilize terminology such as “may,” “will,” “should,”
“likely,” “expects,” “anticipates,” “estimates,” “believes” or “plans,”
or comparable terminology, are forward-looking statements based on current expectations and assumptions, and entail various risks and
uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important
factors known to us that could cause such material differences are identified in this report and in our annual report on Form 10-K for
the year ended December 31, 2021. We undertake no obligation to correct or update any forward-looking statements, whether as a result
of new information, future events or otherwise, except as may be required under applicable law. You are advised, however, to consult any
future disclosures we make on related subjects in future reports to the SEC .
Overview
We are a pharmaceutical company
focusing on the research and development of proprietary drugs including our anticancer compound Adva-27a, our anticancer K1.1 mRNA molecules,
and anti-coronavirus lead compound, SBFM-PL4.
In addition, we develop science-based
nutritional supplements through our wholly owned Canadian subsidiary, Sunshine Biopharma Canada Inc. (“Sunshine Canada”),
and we currently sell one nutritional supplement product, Essential 9 tm .
On October 20, 2022, we completed the acquisition of Nora Pharma Inc.
(“Nora Pharma”), a Canadian generic pharmaceuticals company. Based in the greater Montreal area, Nora Pharma has 36 employees
and operates in a 15,000 square foot facility certified by Health Canada. Nora Pharma currently offers over 50 pharmaceutical products,
including generic prescription drugs, over-the-counter products and biosimilars. Nora Pharma sales were $10.7 million for its fiscal year
ended June 30, 2022 and its net income for this period was $0.3 million (USD).
Proprietary Drug Development Operations
SBFM-PL4 Anti-Coronavirus Treatment
The following is a summary of
the development to date of our coronavirus treatment project:
·
On May 22, 2020, we filed a patent application in the
United States for a new treatment for Coronavirus infections. Our patent application covers composition subject matter pertaining to
small molecules for inhibition of the Coronavirus main protease (Mpro) and papain-like protease (PLpro). Both enzymes are essential
for viral replication. In addition to being involved in maturation of specific viral proteins, PLpro is responsible for suppression
of the human immune system making the virus more virulent. The small molecules covered by the patent application were designed by
Dr. Steve N. Slilaty, our chief executive officer. The patent application has a priority date of May 22, 2020.
·
In August 2020, we completed the synthesis of four different potential inhibitors of PLpro. These compounds are based on the technology described in our patent application filed on May 22, 2020.
·
In September 2020, we completed the screening of our four compounds and subsequently identified a lead Anti-Coronavirus drug candidate (SBFM-PL4). The screening which pinpointed the lead compound was performed at the University of Georgia, College of Pharmacy.
·
The next steps in our SBFM-PL4 drug development plan will involve conducting additional in vitro studies followed by cell culture assays and assessment in Coronavirus infected mice before entering human clinical trials.
·
In February 2022, we expanded our search for additional PLpro inhibitors by entering into a research agreement with the University of Arizona for the purposes of conducting research focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of three University of Arizona owned PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research Project”). Under the agreement, the University of Arizona granted the Company a first option to negotiate a commercial, royalty-bearing license for all intellectual property developed by University of Arizona personnel under the Research Project. In addition, the Company and the University of Arizona entered into an Option Agreement whereby the Company was granted a first option to negotiate a royalty-bearing commercial license for the underlying technology of the Research Project. Intending to move forward with the technology, we submitted a Notice of Option Exercise to the University of Arizona on September 13, 2022.
12
Adva-27a Anticancer Compound
In the area of oncology, our proprietary
drug development activities have been focused on the development of a small molecule called Adva-27a for the treatment of aggressive forms
of cancer. A Topoisomerase II inhibitor, Adva-27a has been shown to be effective at destroying Multidrug Resistant Cancer cells including
Pancreatic Cancer cells, Breast Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells (Published in ANTICANCER RESEARCH,
Volume 32, Pages 4423-4432, October 2012). Sunshine Biopharma is direct owner of all issued patents pertaining to Adva-27a including U.S.
Patents Number 8,236,935 and 10,272,065.
Figure 1
Adva-27a is a GEM-difluorinated
C-glycoside derivative of Podophyllotoxin (see Figure 1). Another derivative of Podophyllotoxin called Etoposide is currently on the market
and is used to treat various types of cancer including leukemia, lymphoma, testicular cancer, lung cancer, brain cancer, prostate cancer,
bladder cancer, colon cancer, ovarian cancer, liver cancer and several other forms of cancer. Etoposide is one of the most widely used
anticancer drugs. Adva-27a and Etoposide are similar in that they both attack the same target in cancer cells, namely the DNA unwinding
enzyme, Topoisomerase II. Unlike Etoposide however, Adva-27a is able to penetrate and destroy Multidrug Resistant Cancer cells. In addition,
Adva-27a has been shown to have distinct and more desirable biological and pharmacological properties compared to Etoposide. In side-by-side
studies using Multidrug Resistant Breast Cancer cells and Etoposide as a reference, Adva-27a showed markedly greater cell killing activity
(see Figure 2).
Figure 2
13
The next sequence of steps in
our Adva-27a development program includes:
·
GMP Manufacturing of 2 kilograms for use in IND-Enabling Studies and Phase I Clinical Trials
·
IND-Enabling Studies
·
Regulatory Filing (Fast-Track status anticipated)
·
Phase I Clinical Trials (Pancreatic Cancer indication)
Adva-27a’s initial indication
will be pancreatic cancer for which there are currently little or no treatment options available. We are planning to conduct our clinical
trials at McGill University’s Jewish General Hospital in Montreal, Canada. All aspects of the clinical trials in Canada will employ
FDA standards at all levels.
According to the American Cancer
Society, nearly 1.5 million new cases of cancer are diagnosed in the U.S. each year. While particularly effective against Multidrug Resistant
Cancer, we believe Adva-27a can potentially treat all cancer types, particularly those in which Topoisomerase II has been amplified. We
believe that upon successful completion of Phase I Clinical Trials we may receive one or more offers from large pharmaceutical companies
to purchase or license our drug. However, there are no assurances that our Phase I Trials will be successful, or if successful, that any
pharmaceutical companies will make an acceptable offer to us. In the event we do not consummate such a transaction, we will require significant
capital in order to secure regulatory approval, manufacture and market our new drug on our own.
K1.1 Anti-cancer mRNA
In June 2021, we initiated a new
research project in which we set out to determine if certain mRNA molecules can be used as anti-cancer agents. The data collected to date
have shown that a selected group of mRNA molecules are capable of destroying cancer cells in vitro including multidrug resistant breast
cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2). Other studies using non-transformed
(normal) human cells (HMEC cells) showed that these mRNA molecules had little cytotoxic effects. These new mRNA molecules, bearing the
laboratory name K1.1, are readily adaptable for delivery into patients using the mRNA vaccine technology. In April 2022, we filed a provisional
patent application in the United States covering the subject mRNA molecules. We are currently in discussion with several potential partners
for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles (K1.1::LNP). Using the K1.1::LNP formulations, we plan
to commence mice xenograft studies within approximately the next twelve months.
Nutritional Supplements Operations
Our wholly owned Canadian subsidiary,
Sunshine Canada, focuses on the development and marketing of science-based nutritional supplements. In December 2018, we completed the
development of our first nutritional supplement product which we named Essential 9 ™ .
On December 14, 2018, Health Canada issued NPN 80089663 through which it authorized us to manufacture and sell the Essential 9™
product. Our Essential 9™ nutritional supplement product was originally launched as a tablet and has now been reformatted into vegan
capsules. Our Essential 9 tm capsules contain a balanced formula of the 9 Essential
Amino Acids that the human body cannot make. Essential Amino Acids are 9 out of the 20 amino acids required for protein synthesis. Proteins
are involved in all body functions – From the musculature and immune system to hormones and neurotransmitters. Like vitamins, Essential
Amino Acids cannot be made by the human body and must be obtained through diet. Deficiency in one or more of the 9 Essential Amino Acids
can lead to loss of muscle mass, fatigue, weight gain and reduced ability to build muscle mass in athletes. Our Essential 9™ provides
all 9 Essential Amino Acids in freeform and in the proportions recommended by Health Canada. Essential 9™ is currently available
on Amazon.com and Amazon.ca. Figure 3 below shows our reformatted 60-Capsule Essential 9™ product.
14
Figure 3
In November 2019, we received
Health Canada approval for another nutritional supplement, a new Calcium-Vitamin D tablet. Health Canada issued NPN 80093432 through which
it authorized us to manufacture and sell the new Calcium-Vitamin D supplement under the brand name Essential Calcium-Vitamin D™.
Vitamin D is a group of steroid-like molecules responsible for increasing intestinal absorption of calcium, magnesium, and phosphate.
They are also involved in multiple other biological functions, including proper functioning of the immune system, promoting healthy growth
of bone, and reduction of inflammation. The most important compounds in this group are ergocalciferol (Vitamin D2) and cholecalciferol
(Vitamin D3). Sunshine Biopharma’s Essential Calcium-Vitamin D™ tablets contain both of these compounds as well as calcium
for optimum health benefits. We are considering potentially launching this product in 2023.
Results of Operations
Comparison of results of operations for the
three months ended September 30, 2022 and 2021
During the three months ended
September 30, 2022, we generated revenues of $132,808, compared to revenue of $50,376 for the three months ended September 30, 2021. The
increase is attributable to increased marketing efforts. All of these revenues were generated from our science-based nutritional supplements
operations. The direct cost for generating these revenues was $65,783 for the three months ended September 30, 2022 (49.5%), compared
to $19,506 (38.7%) for the three months ended September 30, 2021. The increase in cost of sales in 2022 is due to increases in manufacturing
cost. Our gross profit increased to $67,025 for the three months ended September 30, 2022, compared to a gross profit of $30,870 for the
same period in 2021.
General and administrative expenses
during the three month period ended September 30, 2022 were $1,785,005 compared to $527,129 during the three month period ended September
30, 2021, an increase of $1,257,876. Overall, we incurred a loss of $1,717,980 from our operations in the three month period ended September
30, 2022, compared to a loss from operations of $496,259 in the similar period of 2021.
In addition, we had interest income of $260,938, interest expense of
$2, and debt forgiveness of $0, during the three months ended September 30, 2022, compared to interest income of $0, interest expense
of $46,849, and debt forgiveness of $7,688, during the three months ended September 30, 2021. This was primarily due to the transitioning
of our financing from convertible debt to equity. We incurred no losses related to debt conversion during the three months ended September
30, 2022, compared to $3,504,000 in losses arising from debt conversion during the three months ended September 30, 2021. This was also
due to the transitioning of our financing from convertible debt to equity.
As a result, we incurred a net
loss of $1,457,019 for the three month period ended September 30, 2022, compared to a net loss of $4,039,383 for the three month period
ended September 30, 2021.
15
Comparison of results of operations for the
nine months ended September 30, 2022 and 2021
During the nine months ended September
30, 2022, we generated revenues of $405,760, compared to revenue of $143,308 for the nine months ended September 30, 2021. The increase
is attributable to increased marketing efforts. All of these revenues were generated from our science-based nutritional supplements operations.
The direct cost for generating these revenues was $200,311 for the nine months ended September 30, 2022 (49.4%), compared to $56,541 (39.5%)
for the nine months ended September 30, 2021. The increase in cost of sales in 2022 is due to increases in manufacturing cost. Our gross
profit increased to $205,449 for the nine months ended September 30, 2022, compared to a gross profit of $86,767 for the same period in
2021.
General and administrative expenses
during the nine month period ended September 30, 2022 were $3,842,589 compared to $2,247,270 during the nine month period ended September
30, 2021, an increase of $1,595,319. Overall, we incurred a loss of $3,637,140 from our operations in the nine month period ended September
30, 2022, compared to a loss from operations of $2,160,503 in the similar period of 2021.
In addition, we had interest
income of $406,984, interest expense of $12,866, and debt forgiveness of $10,852 during the nine months ended September 30, 2022, compared
to interest income of $0, interest expense of $292,188, and debt forgiveness of $58,940 during the nine months ended September 30, 2021.
This was primarily due to the transitioning of our financing from convertible debt to equity. We incurred no losses related to debt conversion
during the nine months ended September 30, 2022, compared to $10,709,843 in losses arising from debt conversion during the nine months
ended September 30, 2021. This was also due to the transitioning of our financing from convertible debt to equity.
As a result, we incurred a net
loss of $3,232,125 for the nine month period ended September 30, 2022, compared to a net loss of $13,103,563 for the nine month period
ended September 30, 2021.
Liquidity and Capital Resources
As of September 30, 2022, we had cash and cash equivalents
of $40,555,931.
Net cash used in operating activities
was $3,001,746 during the nine months ended September 30, 2022, compared to $1,517,015 during the nine month period ended September 30,
2021. The increase was a result of increased marketing and R&D activities as well as increases in professional fees related to becoming
a Nasdaq listed company.
Cash flows provided by financing
activities were $41,561,363 for the nine months ended September 30, 2022, compared to $2,928,339 for the nine month period ended September
30, 2021. The increase was a result of three financing events completed in February, March and April 2022, as well as warrant exercises.
Cash flows used in investing activities
were $0 for the nine months ended September 30, 2022 and September 30, 2021.
We are not generating adequate
revenues from our operations to fully implement our business plan as set forth herein. On February 17, 2022, we received net proceeds
of approximately $6.8 million from the sale of common stock and warrants in an underwritten public offering. On March 14, 2022, we received
net proceeds of approximately $6.8 million from the sale of common stock and warrants in a private placement. On April 28, 2022, we received
net proceeds of approximately $16.8 million from the sale of common stock and warrants in a private placement. We believe our existing
cash will be sufficient to fund our operations, including general and administrative expenses, expanded research and development activities,
and nutritional supplement business, for the next 24 months. There is no assurance our estimates will be accurate. We have no committed
sources of capital and we anticipate that we will need to raise additional capital in the future, including for further research and development
activities and possibly clinical trials, as well as expansion of our generic pharmaceutical operations arising from the Nora Pharma acquisition.
Additional capital may not be available on terms acceptable to us, or at all.
16
Critical Accounting Policies and Estimates
Critical Accounting Estimates
The discussion and analysis of
our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make
estimates and judgments that affect the amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets
and liabilities. On an on-going basis, we evaluate our estimates based on historical experience and on various other assumptions that
are believed 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.
For a detailed list of significant
accounting policies, please see our annual report on Form 10-K for the fiscal year ended December 31, 2021, including our financial statements
and notes thereto included therein as filed with the SEC on March 21, 2022,
Recently Adopted Accounting Standards
In February 2020, the FASB issued
ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC Paragraphs Pursuant to
SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards Update No. 2016-02,
Leases (Topic 842) which amends the effective date of the original pronouncement for smaller reporting companies. ASU 2016-13
and its amendments will be effective for the Company for interim and annual periods in fiscal years beginning after December 15, 2022.
The Company believes the adoption will modify the way the Company analyzes financial instruments, but it does not anticipate a material
impact on results of operations. The Company is in the process of determining the effects adoption will have on its consolidated financial
statements.
In August 2020, the FASB issued
ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts
in Entity’s Own Equity (Subtopic 815 – 40) , (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for certain
financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s
own equity. The ASU2020-06 amendments are effective for fiscal years beginning after December 15, 2023, and interim periods within those
fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim
periods within those fiscal years. The Company is evaluating the impact of this guidance on its unaudited consolidated financial statements.
Off Balance-Sheet Arrangements
None.
17
Item 3. Quantitative and Qualitative Disclosures
About Market Risk.
We are a smaller reporting company
and are not required to provide the information under this item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation
of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures
(as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this report.
These controls are designed to
ensure that information required to be disclosed in the reports we file or submit pursuant to the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission, and that such
information is accumulated and communicated to our management, including our CEO and CFO, to allow timely decisions regarding required
disclosure.
Based on this evaluation, our
management, including our CEO and CFO concluded that our disclosure controls and procedures were effective as of September 30, 2022, at
reasonable assurance levels.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal
control over financial reporting during the quarter ended September 30, 2022, that have materially affected, or are reasonably likely
to materially affect, our internal control over financial reporting.
18
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
We are not party to, and our property
is not the subject of, any material legal proceedings.
Item 1A. Risk Factors.
We are a smaller reporting company
and are not required to provide the information under this item.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not Applicable.
Item 5. Other Information.
None.
Item 6. Exhibits.
Exhibit No.
Description
31.1
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
31.2
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2022 *
32.1
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 *
101
Inline XBRL Document Set for the financial statements and accompanying notes in Part I, Item 1, of this Quarterly Report on Form 10-Q.*
104
Inline XBRL for the cover page of this Quarterly Report on Form 10-Q, included in the Exhibit 101 Inline XBRL Document Set.*
*
Filed herewith.
19
SIGNATURES
Pursuant to the requirements of
the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized, on November 7, 2022.
SUNSHINE BIOPHARMA, INC.
By:
/s/ Dr. Steve N. Slilaty
Dr. Steve N. Slilaty
Chief Executive Officer (principal executive officer)
By:
/s/ Camille Sebaaly
Camille Sebaaly
Chief Financial Officer (principal financial and accounting officer)
20
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.