−Removed: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
−Removed: CONDITION AND RESULTS OF OPERATIONS
−Removed: The following discussion should be read in
−Removed: conjunction with our consolidated financial statements and notes thereto included herein.
−Removed: This discussion includes forward-looking statements
−Removed: within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities
−Removed: Exchange Act of 1934, as amended, or the Exchange Act.
−Removed: The statements regarding Sunshine Biopharma, Inc.
−Removed: contained in this Report that
−Removed: are not historical in nature, particularly those that utilize terminology such as “may,” “will,” “should,”
−Removed: “likely,” “expects,” “anticipates,” “estimates,” “believes” or “plans,”
−Removed: or comparable terminology, are forward-looking statements based on current expectations and assumptions, and entail various risks and
−Removed: uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements.
−Removed: 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
−Removed: the year ended December 31, 2023.
−Removed: We undertake no obligation to correct or update any forward-looking statements, whether as a result
−Removed: of new information, future events or otherwise, except as may be required under applicable law.
−Removed: You are advised, however, to consult
−Removed: any future disclosures we make on related subjects in future reports we file with the SEC.
+Added: DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
+Added: The following
+Added: discussion should be read in conjunction with our consolidated financial statements and notes thereto included herein.
+Added: This discussion
+Added: includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act,
+Added: and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act.
+Added: The statements contained in this Report that are not historical in nature, particularly those that utilize terminology such as “may,”
+Added: “will,” “should,” “likely,” “expects,” “anticipates,” “estimates,”
+Added: “believes” or “plans,” or comparable terminology, are forward-looking statements based on current expectations
+Added: and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed
+Added: in such forward-looking statements.
+Added: Important factors known to us that could cause such material differences are identified in this report
+Added: and in our annual report on Form 10-K for the year ended December 31, 2023.
+Added: We undertake no obligation to correct or update any forward-looking
+Added: statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law.
+Added: advised, however, to consult any future disclosures we make on related subjects in future reports we file with the SEC.
About Sunshine Biopharma
−Removed: We are a pharmaceutical company offering and researching life-saving
−Removed: medicines in a wide variety of therapeutic areas, including oncology and antivirals.
−Removed: We operate two wholly owned subsidiaries:
−Removed: (“Nora Pharma”), a Canadian corporation with a portfolio consisting of 61 generic prescription drugs on the market
−Removed: in Canada, and (ii) Sunshine Biopharma Canada Inc.
−Removed: (“Sunshine Canada”), a Canadian corporation which develops and sells nonprescription
−Removed: over-the-counter (“OTC”) products.
−Removed: In addition, we are conducting a proprietary drug development program
−Removed: which is comprised of (i) K1.1 mRNA targeted for liver cancer, (ii) SBFM-PL4, PLpro protease inhibitor for SARS Coronavirus infections,
−Removed: and (iii) Adva-27a for pancreatic cancer.
−Removed: Development of the latter has been paused pending further analysis of unfavorable in vitro results
−Removed: obtained in the second half of 2023.
−Removed: See “Drugs in Development” below.
−Removed: We were incorporated in the State of Colorado on August 31, 2006, and
−Removed: on October 15, 2009, we acquired Sunshine Biopharma, Inc.
−Removed: in a transaction classified as a reverse acquisition.
+Added: We are a pharmaceutical
+Added: company offering and researching life-saving medicines in a wide variety of therapeutic areas, including oncology and antivirals.
+Added: operate two wholly owned subsidiaries:
+Added: (i) Nora Pharma Inc.
+Added: (“Nora Pharma”), a Canadian corporation with a portfolio consisting
+Added: of 63 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc.
+Added: (“Sunshine Canada”), a
+Added: Canadian corporation which develops and sells nonprescription over-the-counter (“OTC”) products.
+Added: In addition, we
+Added: are conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA targeted for liver cancer, (ii) SBFM-PL4, a
+Added: PLpro protease inhibitor for SARS Coronavirus infections, and (iii) Adva-27a for pancreatic cancer.
+Added: Development of the latter has been
+Added: paused pending further analysis of unfavorable in vitro results obtained in the second half of 2023.
+Added: See “Drugs in Development”
+Added: We were incorporated
+Added: in the State of Colorado on August 31, 2006, and on October 15, 2009, we acquired Sunshine Biopharma Inc.
+Added: in a transaction classified
+Added: as a reverse acquisition.
Sunshine Biopharma Inc.
−Removed: held an exclusive license to a new anticancer drug bearing the laboratory name, Adva-27a (the “License Agreement”).
−Removed: Upon completion
−Removed: of the reverse acquisition, we changed our name to Sunshine Biopharma, Inc.
−Removed: and began operating as a pharmaceutical company.
−Removed: In December 2015, we acquired all worldwide issued (US Patent Number
−Removed: 8,236,935, and 10,272,065) and pending patents under PCT/FR2007/000697 and PCT/CA2014/000029 for the Adva-27a anticancer compound and
−Removed: terminated the License Agreement.
−Removed: Development of Adva-27a has recently been paused pending further analysis of unexpected in vitro results
−Removed: obtained in the latter part of 2023.
+Added: held an exclusive license to a new anticancer drug bearing the laboratory name, Adva-27a
+Added: (the “License Agreement”).
+Added: Upon completion of the reverse acquisition, we changed our name to Sunshine Biopharma Inc.
+Added: began operating as a pharmaceutical company.
+Added: In December 2015,
+Added: we acquired all issued (US Patent Number 8,236,935, and 10,272,065) and pending patents under PCT/FR2007/000697 and PCT/CA2014/000029
+Added: for the Adva-27a anticancer compound and terminated the License Agreement.
+Added: Development of Adva-27a has recently been paused pending further
+Added: analysis of unexpected in vitro results obtained in the latter part of 2023.
See “Drugs in Development” below.
−Removed: In early 2020, we initiated a new R&D project focused on the development
−Removed: of a treatment for COVID-19 and on May 22, 2020, we filed a provisional patent application in the United States for the new coronavirus
−Removed: The patent application covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus
−Removed: protease, Mpro.
−Removed: On April 30, 2021, we filed a PCT application containing new research results and extending coverage to include the Coronavirus
−Removed: Papain-Like protease, PLpro.
−Removed: In June 2021, we initiated another R&D project in which we set
−Removed: out to determine if certain mRNA molecules can be used as anticancer agents.
−Removed: The data obtained for mRNA molecules bearing the laboratory
−Removed: name K1.1 became the subject of a new patent application filed in April 2022.
−Removed: On October 20, 2022, we acquired Nora Pharma Inc.
−Removed: (“Nora Pharma”),
−Removed: a Canadian generic pharmaceuticals company based in the greater Montreal area.
−Removed: Nora Pharma has 46 employees and operates in a 23,500 square
−Removed: foot facility certified by Health Canada.
−Removed: Nora Pharma currently has 61 generic prescription drugs on the market in Canada and is planning
−Removed: to launch 32 additional generic prescription drugs in 2024 and 2025.
+Added: In early 2020, we
+Added: initiated a new R&D project focused on the development of a treatment for COVID-19 and on May 22, 2020, we filed a provisional patent
+Added: application in the United States for the new coronavirus treatment.
+Added: The patent application covers composition subject matter pertaining
+Added: to small molecules for inhibition of the main Coronavirus protease, Mpro.
+Added: On April 30, 2021, we filed a PCT application containing new
+Added: research results and extending coverage to include inhibitors for the Coronavirus Papain-Like protease, PLpro.
+Added: In June 2021, we
+Added: initiated another R&D project in which we set out to determine if certain mRNA molecules can be used as anticancer agents.
+Added: obtained for mRNA molecules bearing the laboratory name K1.1 became the subject of a new patent application filed in April 2022.
+Added: On October 20,
+Added: 2022, we acquired Nora Pharma, a Canadian generic pharmaceuticals company based in the greater Montreal area.
+Added: Nora Pharma has 46
+Added: employees and operates in a 23,500 square foot facility certified by Health Canada.
+Added: Nora Pharma currently has 63 generic
+Added: prescription drugs on the market in Canada and is planning to launch 32 additional generic prescription drugs in the remainder of
+Added: 2024 and 2025.
Products on the Market
−Removed: Through Nora Pharma we currently have the following generic prescription
−Removed: drugs on the market in Canada:
+Added: Through Nora Pharma we currently have
+Added: the following generic prescription drugs on the market in Canada:
Action/Indication
43 unchanged sentences
Central nervous system
−Removed: ________________
+Added: Cardiovascular
+Added: Central nervous system
+Added: Cardiovascular
+Added: Telmisartan HCTZ
+Added: Cardiovascular
+Added: Micardis Plus®
+Added: Anticonvulsant
+Added: Acetaminophen
+Added: nervous system
+Added: Smoking cessation
+Added: Zoledronic Acid*
+Added: Central nervous system
+Added: Central nervous system
*Sold through distribution agreements
−Removed: In addition to the 61 drugs currently on the market, we have 32 additional
−Removed: drugs scheduled to be launched in 2024 and 2025.
−Removed: These new drugs will address various human health areas including cardiovascular, oncology,
−Removed: gastroenterology, central nervous system, diabetes, urology, endocrinology, anti-infective, and anti-inflammatory.
−Removed: Among the new drugs
−Removed: to be launched in 2024 is NIOPEG®, a biosimilar of NEULASTA®.
−Removed: Like NEULASTA®, NIOPEG® is a long-acting form of recombinant
−Removed: human granulocyte colony-stimulating factor (filgrastim).
−Removed: It is indicated to decrease the incidence of infection in patients with non-myeloid
−Removed: malignancies receiving anti-neoplastic therapy.
−Removed: Nora Pharma received Health Canada marketing approval for NIOPEG® on April 17, 2024.
−Removed: NIOPEG® is anticipated to be on the market in Canada in October 2024.
−Removed: We believe the addition of these new products to our existing portfolio
−Removed: will strengthen our presence in the Canadian $9.7 billion a year generic drugs market and provide us with greater access to pharmacies
−Removed: as we become more of a go-to supplier for every-day and specialty medicines.
+Added: addition to the 63 drugs currently on the market, we have 32 additional
+Added: drugs scheduled to be launched in Q4 2024 and in 2025.
+Added: These new drugs will address various human health areas including cardiovascular,
+Added: oncology, gastroenterology, central nervous system, diabetes, urology, endocrinology, anti-infective, and anti-inflammatory.
+Added: new drugs to be launched in 2024 is NIOPEG®, a biosimilar of NEULASTA®.
+Added: Like NEULASTA®, NIOPEG® is a long-acting form
+Added: of recombinant human granulocyte colony-stimulating factor (filgrastim).
+Added: It is indicated to decrease the incidence of infection in patients
+Added: with non-myeloid malignancies receiving anti-neoplastic therapy.
+Added: Nora Pharma received Health Canada marketing approval for NIOPEG®
+Added: on April 17, 2024.
+Added: NIOPEG® is anticipated to be on the market in Canada in Q4 2024.
+Added: We believe the addition
+Added: of these new products to our existing portfolio will strengthen our presence in the Canadian $9.7 billion a year generic drugs market
+Added: and provide us with greater access to pharmacies as we become more of a go-to supplier for every-day and specialty medicines.
Drugs in Development
−Removed: The following table summarizes our proprietary drugs in development:
+Added: The following table summarizes our proprietary
+Added: drugs in development:
Adva-27a (Small Molecule)
6 unchanged sentences
Animal Testing
−Removed: _____________
−Removed: *See “ Adva-27a Anticancer Compound ”
−Removed: Adva-27a Anticancer Compound
−Removed: Adva-27a is a small molecule designed for the treatment of aggressive
−Removed: forms of cancer.
−Removed: A Topoisomerase II inhibitor, Adva-27a has been shown to be effective at destroying Multidrug Resistant Cancer cells
−Removed: including Pancreatic Cancer cells, Breast Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells (Published in ANTICANCER
−Removed: RESEARCH, Volume 32, Pages 4423-4432, October 2012).
−Removed: We are the direct owner of all patents pertaining to Adva-27a including U.S.
−Removed: Number 8,236,935 and 10,272,065.
−Removed: In December 2022, we entered into a research
−Removed: agreement with the Jewish General Hospital (“JGH”), to conduct the IND-enabling studies of Adva-27a (the “Research
−Removed: In August 2023, we were informed by the JGH that the laboratory test results of the Adva-27a molecule
−Removed: were not favorable.
−Removed: After conclusion of an internal review of the laboratory results on November 2, 2023, we provided notice to JGH
−Removed: of termination of the Research Agreement.
−Removed: We have paused the IND-enabling studies of Adva-27a pending a review of the results and
−Removed: the possibility of chemical modification of the compound to address the suboptimal performance of the molecule in certain
−Removed: K1.1 Anticancer mRNA
−Removed: In June 2021, we initiated a new research project in which we set out
−Removed: to determine if certain mRNA molecules can be used as anti-cancer agents.
−Removed: The data collected to date have shown that a selected group
−Removed: of mRNA molecules are capable of destroying cancer cells in vitro including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian
−Removed: adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2).
−Removed: Studies using non-transformed (normal) human cells (HMEC cells)
−Removed: showed that these mRNA molecules had little cytotoxic effects.
−Removed: These new mRNA molecules, bearing the laboratory name K1.1, are readily
−Removed: adaptable for delivery into patients using the mRNA vaccine technology.
−Removed: In April 2022, we filed a provisional patent application in the
−Removed: United States covering the subject mRNA molecules.
−Removed: In November 2022, we concluded an agreement with a specialized commercial
−Removed: partner for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles (“LNP”) for use to conduct xenograft
−Removed: mice studies.
−Removed: The initial results of our xenograft mice studies indicate that our K1.1 mRNA-LNP is effective at reducing the size of liver
−Removed: cancer xenograft tumors in mice.
−Removed: We are currently seeking to confirm these results by conducting additional xenograft experiments on a
−Removed: broader scale and in more detailed dose-response studies.
−Removed: SBFM-PL4 SARS Coronavirus Treatment
−Removed: The initial genome expression products following infection by Betacoronavirus,
−Removed: the causative agent of COVID-19, are two large polyproteins, referred to as pp1a and pp1ab.
−Removed: These two polyproteins are cleaved at 15 specific
−Removed: sites by two virus encoded proteases, called Mpro and PLpro, to generate 16 different non-structural proteins essential for viral replication.
−Removed: Mpro and PLpro represent attractive anti-viral drug development targets as they play a central role in the early stages of viral replication.
−Removed: PLpro is of particular interest as a therapeutic target in that, in addition to processing essential viral proteins, it is also responsible
−Removed: for suppression of the human immune system making the virus more life-threatening.
−Removed: PLpro is present only in Betacoronaviruses, the subgroup
−Removed: of Coronaviruses represented by the highly pathogenic SARS-CoV, MERS-CoV, and SARS-CoV-2.
−Removed: Our Anti-Coronavirus research effort has been focused on developing
−Removed: an inhibitor of PLpro and, on May 22, 2020, we filed a patent application in the United States covering composition subject matter pertaining
−Removed: to small molecules for inhibition of the Coronavirus PLpro as well as Mpro.
−Removed: In February 2022, we expanded our PLpro inhibitors research effort
−Removed: by entering into a research agreement with the University of Arizona for the purposes of conducting research focused on determining the
−Removed: in vivo safety, pharmacokinetics, and dose selection properties of three University of Arizona owned PLpro inhibitors, to be followed
−Removed: by efficacy testing in mice infected with SARS-CoV-2 (the “Research Project”).
−Removed: Under the agreement, the University of Arizona
−Removed: granted us a first option to negotiate a commercial, royalty-bearing license for all intellectual property developed by University of
−Removed: Arizona under the Research Project.
−Removed: In addition, we and the University of Arizona have entered into an option agreement (the “Option
−Removed: Agreement”) whereby we were granted a first option to negotiate a royalty-bearing commercial license for the underlying technology
−Removed: of the Research Project.
−Removed: On September 13, 2022, we exercised our options, and on February 24, 2023, we entered into an exclusive worldwide
−Removed: license agreement with the University of Arizona for all of the technology related to the Research Project.
−Removed: We have recently broadened our objective to include the development
−Removed: of an injectable drug candidate of first-in-class PLpro inhibitor to treat SARS-CoV2 and potentially SARS-CoV and MERS-CoV infection in
−Removed: patients who could not use Paxlovid, Molnupiravir, or Remdesivir, due to concerns about drug interactions and possible ‘rebound’
−Removed: infections and other side effects.
+Added: * See “ Adva-27a Anticancer
+Added: Compound ” below
+Added: Adva-27a Anticancer
+Added: Adva-27a is a small
+Added: molecule designed for the treatment of aggressive forms of cancer.
+Added: A Topoisomerase II inhibitor, Adva-27a has been shown to be effective
+Added: at destroying Multidrug Resistant Cancer cells including Pancreatic Cancer cells, Breast Cancer cells, Small-Cell Lung Cancer cells and
+Added: Uterine Sarcoma cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012).
+Added: We are the direct owner of all patents
+Added: pertaining to Adva-27a including U.S.
+Added: Patents Number 8,236,935 and 10,272,065.
+Added: In December 2022,
+Added: we entered into a research agreement with the Jewish General Hospital (“JGH”), to conduct the IND-enabling studies of Adva-27a
+Added: (the “Research Agreement”).
+Added: In August 2023, we were informed by the JGH that the laboratory test results of the Adva-27a
+Added: molecule were not favorable.
+Added: After conclusion of an internal review of the laboratory results on November 2, 2023, we provided notice
+Added: to JGH of termination of the Research Agreement.
+Added: We have paused the IND-enabling studies of Adva-27a pending a review of the results
+Added: and the possibility of chemical modification of the compound to address the suboptimal performance of the molecule in certain studies.
+Added: K1.1 Anticancer
+Added: In June 2021, we
+Added: initiated a new research project in which we set out to determine if certain mRNA molecules can be used as anti-cancer agents.
+Added: collected to date have shown that a selected group of mRNA molecules are capable of destroying cancer cells in vitro including multidrug
+Added: resistant breast cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2).
+Added: Studies using
+Added: non-transformed (normal) human cells (HMEC cells) showed that these mRNA molecules had little cytotoxic effects.
+Added: These new mRNA molecules,
+Added: bearing the laboratory name K1.1, are readily adaptable for delivery into patients using the mRNA vaccine technology.
+Added: In April 2022,
+Added: we filed a provisional patent application in the United States covering the subject mRNA molecules.
+Added: In November 2022,
+Added: we concluded an agreement with a specialized commercial partner for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles
+Added: (“LNP”) for use to conduct xenograft mice studies.
+Added: The initial results of our xenograft mice studies indicate that our K1.1
+Added: mRNA-LNP is effective at reducing the size of liver cancer xenograft tumors in mice.
+Added: We are currently seeking to confirm these results
+Added: by conducting additional xenograft experiments on a broader scale and in more detailed dose-response studies.
+Added: SBFM-PL4 SARS Coronavirus
+Added: The initial genome
+Added: expression products following infection by Betacoronavirus, the causative agent of COVID-19, are two large polyproteins, referred to
+Added: as pp1a and pp1ab.
+Added: These two polyproteins are cleaved at 15 specific sites by two virus encoded proteases, called Mpro and PLpro, to
+Added: generate 16 different non-structural proteins essential for viral replication.
+Added: Mpro and PLpro represent attractive anti-viral drug development
+Added: targets as they play a central role in the early stages of viral replication.
+Added: PLpro is of particular interest as a therapeutic target
+Added: in that, in addition to processing essential viral proteins, it is also responsible for suppression of the human immune system making
+Added: the virus more life-threatening.
+Added: PLpro is present only in Betacoronaviruses, the subgroup of Coronaviruses represented by the highly
+Added: pathogenic SARS-CoV, MERS-CoV, and SARS-CoV-2.
+Added: Our Anti-Coronavirus
+Added: research effort has been focused on developing an inhibitor of PLpro and, on May 22, 2020, we filed a patent application in the United
+Added: States covering composition subject matter pertaining to small molecules for inhibition of the Coronavirus PLpro as well as Mpro.
+Added: In February 2022,
+Added: we expanded our PLpro inhibitors research effort by entering into a research agreement with the University of Arizona for the purposes
+Added: of conducting research focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of three University
+Added: of Arizona owned PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research Project”).
+Added: Under the agreement, the University of Arizona granted us a first option to negotiate a commercial, royalty-bearing license for all intellectual
+Added: property developed by University of Arizona under the Research Project.
+Added: In addition, we and the University of Arizona have entered into
+Added: an option agreement (the “Option Agreement”) whereby we were granted a first option to negotiate a royalty-bearing commercial
+Added: license for the underlying technology of the Research Project.
+Added: On September 13, 2022, we exercised our options, and on February 24, 2023,
+Added: we entered into an exclusive worldwide license agreement with the University of Arizona for all of the technology related to the Research
+Added: We have recently
+Added: broadened our objective to include the development of an injectable drug candidate of first-in-class PLpro inhibitor to treat SARS-CoV2
+Added: and potentially SARS-CoV and MERS-CoV infection in patients who could not use Paxlovid, Molnupiravir, or Remdesivir, due to concerns
+Added: about drug interactions and possible ‘rebound’ infections and other side effects.
Intellectual Property
−Removed: We are the sole owner of all rights pertaining to Adva-27a.
−Removed: rights are covered by PCT/FR2007/000697 and PCT/CA2014/000029.
−Removed: The patent applications filed under these two PCT's have been issued in
−Removed: the United States under US Patent Number 8,236,935 and 10,272,065.
−Removed: On May 22, 2020, we filed a provisional patent application in the United
−Removed: States for a new treatment for Coronavirus infections.
−Removed: Our patent application covers composition subject matter pertaining to small molecules
−Removed: for inhibition of the main Coronavirus protease, Mpro, an enzyme that is essential for viral replication.
−Removed: The patent application has a
−Removed: priority date of May 22, 2020.
−Removed: On April 30, 2021, we filed a PCT application containing new research results and extending coverage to
−Removed: include the Coronavirus Papain-Like protease, PLpro.
−Removed: The priority date of May 22, 2020 has been maintained in the newly filed PCT application.
−Removed: On April 20, 2022, we filed a provisional patent application in the
−Removed: United States covering mRNA molecules capable of destroying cancer cells in vitro.
−Removed: The patent application contains composition and utility
−Removed: subject matter pertaining to the structure and sequence of the relevant mRNA molecules.
−Removed: Effective February 24, 2023, we became the exclusive, worldwide licensee
−Removed: of the University of Arizona for three (3) patents related to small molecules which inhibit the Coronavirus protease, PLpro.
−Removed: Our wholly owned subsidiary, Nora Pharma, owns 152 DIN’s issued
−Removed: by Health Canada for prescription drugs currently on the market in Canada.
−Removed: These DIN’s were secured through in-licenses or cross-licenses
−Removed: from international manufacturers of generic pharmaceutical products.
−Removed: In addition, we are the owner of four (4) NPN’s issued by Health
−Removed: Canada including (i) NPN 80089663 which authorizes us to manufacture and sell our in-house developed OTC product, Essential•9, (ii)
−Removed: NPN 80093432 which authorizes us to manufacture and sell the OTC product, Calcium-Vitamin D under the brand name Essential Calcium-Vitamin
−Removed: D, (iii) NPN 80125047 which authorizes us to manufacture and sell the OTC product, L-Citrulline, and (iv) NPN 80127436 which authorizes
−Removed: us to manufacture and sell the OTC product, Taurine.
+Added: We are the sole
+Added: owner of all rights pertaining to Adva-27a.
+Added: These patent rights are covered by PCT/FR2007/000697 and PCT/CA2014/000029.
+Added: The patent applications
+Added: filed under these two PCT's have been issued in the United States under US Patent Number 8,236,935 and 10,272,065.
+Added: On May 22, 2020,
+Added: we filed a provisional patent application in the United States for a new treatment for Coronavirus infections.
+Added: Our patent application
+Added: covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro, an enzyme that
+Added: is essential for viral replication.
+Added: The patent application has a priority date of May 22, 2020.
+Added: On April 30, 2021, we filed a PCT application
+Added: containing new research results and extending coverage to include the Coronavirus Papain-Like protease, PLpro.
+Added: The priority date of May
+Added: 22, 2020 has been maintained in the newly filed PCT application.
+Added: On April 20, 2022,
+Added: we filed a provisional patent application in the United States covering mRNA molecules capable of destroying cancer cells in vitro.
+Added: patent application contains composition and utility subject matter pertaining to the structure and sequence of the relevant mRNA molecules.
+Added: Effective February
+Added: 24, 2023, we became the exclusive, worldwide licensee of the University of Arizona for three (3) patents related to small molecules which
+Added: inhibit the Coronavirus protease, PLpro.
+Added: Our wholly owned
+Added: subsidiary, Nora Pharma, owns 152 DIN’s issued by Health Canada for prescription drugs currently on the market in Canada.
+Added: DIN’s were secured through in-licenses or cross-licenses from international manufacturers of generic pharmaceutical products.
+Added: In addition, we
+Added: are the owner of four (4) NPN’s issued by Health Canada including (i) NPN 80089663 which authorizes us to manufacture and sell
+Added: our in-house developed OTC product, Essential•9, (ii) NPN 80093432 which authorizes us to manufacture and sell the OTC product,
+Added: Calcium-Vitamin D under the brand name Essential Calcium-Vitamin D, (iii) NPN 80125047 which authorizes us to manufacture and sell the
+Added: OTC product, L-Citrulline, and (iv) NPN 80127436 which authorizes us to manufacture and sell the OTC product, Taurine.
Results of Operations
−Removed: Comparison of
−Removed: results of operations for the three months ended June 30, 2024 and 2023
−Removed: During the three months ended June 30, 2024, we
−Removed: generated $9,303,067 in sales, compared to $5,560,865 for the three months ended June 30, 2023, an increase of $3,742,202, or 67%.
−Removed: increase is attributable to expanded marketing and sales efforts by our wholly owned subsidiary, Nora Pharma.
−Removed: The direct cost for generating
−Removed: these sales was $6,946,810 (75%) for the three months ended June 30, 2024, compared to $3,608,118 (65%) for the three months ended June
−Removed: The increase in the cost of goods sold in 2024 is due to increased cost of manufacturing of the generic prescription drugs.
−Removed: Our gross profit grew to $2,356,257 for the three months ended June 30, 2024, compared to $1,952,747 for the three months ended June 30,
−Removed: and administrative expenses during the three-month period ended June 30, 2024, were $3,624,533, compared to $2,966,635 during the three-month
−Removed: period ended June 30, 2023, an increase of $657,898.
−Removed: The increase was due to increases in legal fees ($77,621), marketing ($123,148),
−Removed: office expense ($293,595), R&D ($67,670), and salaries ($356,009).
−Removed: The increase in salaries was due to the hiring of two (2) new
−Removed: employees and a bonus paid to the CEO of the Company.
−Removed: The only expense category that saw a decrease was consulting, which was reduced
−Removed: Overall, we incurred a loss of $1,268,276 from our operations for the three months ended June 30, 2024, compared to a loss
−Removed: of $1,013,888 from our operations in the three-month period ended June 30, 2023.
−Removed: addition, we had interest income of $143,995 during the three months ended June 30, 2024, compared to net interest income of $203,049
−Removed: during the three months ended June 30, 2023, as a result of less interest earned on cash on hand.
−Removed: a result, we incurred a net loss of $494,300 ($9.94 per share) for the three months ended June 30, 2024, compared to a net loss of $902,108
−Removed: ($71.17 per share) for the three-month period ended June 30, 2023.
−Removed: Comparison of results of operations
−Removed: for the six months ended June 30, 2024 and 2023
−Removed: During the six months ended June 30 2024, we generated
−Removed: revenues of $16,844,113, compared to revenue of $10,454,918 for the six months ended June 30, 2023, an increase of $6,389,195, or 61%.
−Removed: The increase is attributable to increased sales generated by our wholly owned subsidiary, Nora Pharma.
−Removed: The direct cost for generating
−Removed: these revenues was $12,133,519 for the six months ended June 30, 2024 (72%), compared to $6,674,049 (64%) for the six months ended June
−Removed: The increase in the cost of goods sold in 2024 is due to an increase in the cost of manufacturing of generic prescription drugs.
−Removed: Our gross profit increased to $4,710,594 for the six months ended June 30, 2024, compared to a gross profit of $3,780,869 for the same
−Removed: period in 2023.
−Removed: and administrative expenses during the six-month period ended June 30, 2024, were $7,378,640, compared to $6,660,398 during the six-month
−Removed: period ended June 30, 2023, an increase of $718,242.
+Added: of results of operations for the three months ended September 30, 2024 and 2023
+Added: the three months ended September 30, 2024, we generated $8,435,178 in sales, compared to $5,957,668 for the three months ended September
+Added: 30, 2023, an increase of $2,477,510, or 42%.
+Added: The increase is attributable to expanded marketing and sales efforts by our wholly owned
+Added: subsidiary, Nora Pharma.
+Added: The direct cost for generating these sales was $5,569,027 (66%) for the three months ended September 30, 2024,
+Added: compared to $3,967,412 (67%) for
+Added: the three months ended September 30, 2023.
+Added: Our gross profit grew to $2,866,151 for the three months ended September 30, 2024, compared
+Added: to $1,990,256 for the three months ended September 30, 2023.
+Added: General and administrative
+Added: expenses during the three-month period ended September 30, 2024, were $3,972,504, compared to $2,769,730 during the three-month period
+Added: ended September 30, 2023, an increase of $1,202,774.
+Added: The increase was due to increases in accounting fees ($68,422), consulting ($253,251),
+Added: marketing ($40,848), and salaries ($949,473).
+Added: The increase in salaries was due to the hiring of two (2) new employees and a bonus paid
+Added: to the CEO of the Company.
+Added: The only expense category that saw a decrease was R&D, which was reduced by $111,650.
+Added: Overall, we incurred
+Added: a loss of $1,106,353 from our operations for the three months ended September 30, 2024, compared to a loss of $779,474 from our operations
+Added: in the three-month period ended September 30, 2023.
+Added: In addition, we
+Added: had interest income of $108,614 during the three months ended September 30, 2024, compared to net interest income of $168,904 during
+Added: the three months ended September 30, 2023, as a result of less interest earned on cash on hand.
+Added: As a result, we
+Added: incurred a net loss of $1,197,803 ($0.94 per share) for the three months ended September 30, 2024, compared to a net loss of $651,482
+Added: ($50.72 per share) for the three-month period ended September 30, 2023.
+Added: Comparison of results
+Added: of operations for the nine months ended September 30, 2024 and 2023
+Added: During the nine
+Added: months ended September 30, 2024, we generated revenues of $25,279,291, compared to revenue of $16,412,586 for the nine months ended September
+Added: 30, 2023, an increase of $8,866,705, or 54%.
+Added: The increase is attributable to expanded marketing and sales efforts by our wholly owned
+Added: subsidiary, Nora Pharma.
+Added: The direct cost for generating these revenues was $17,702,546 for the nine months ended September 30, 2024 (70%),
+Added: compared to $10,641,461 (65%) for the nine months ended September 30, 2023.
+Added: The increase in the cost of sales in the nine-month
+Added: period of 2024 is related to greater retailer allowances offered to gain access to new regional markets.
+Added: Our gross profit increased to
+Added: $7,576,745 for the nine months ended September 30, 2024, compared to a gross profit of $5,771,125 for the same period in 2023.
+Added: General and administrative
+Added: expenses during the nine-month period ended September 30, 2024, were $11,351,144, compared to $9,369,203 during the nine-month period
+Added: ended September 30, 2023, an increase of $1,981,941.
The increase was a result of increases in accounting ($263,791), legal ($170,871),
−Removed: marketing ($193,281), and office costs ($734,868).
−Removed: The three expense categories that saw a decrease were salaries ($110,536), consulting
+Added: marketing ($234,129), office costs ($781,912), and salaries ($838,937).
+Added: The two expense categories that saw a decrease were consulting
($169,369), and R&D ($254,872).
−Removed: Overall, we incurred a loss of $2,668,046 from our operations in the six-month period ended June 30,
+Added: Overall, we incurred a loss of $3,774,399 from our operations in the nine-month period ended September
30, 2024, compared to a loss from operations of $3,598,078 in the similar period of 2023.
−Removed: addition, we had interest income of $288,084 during the six months ended June 30, 2024, compared to interest income of $416,930 during
−Removed: the six months ended June 30, 2023.
+Added: In addition, we
+Added: had interest income of $396,453 during the nine months ended September 30, 2024, compared to interest income of $517,163 during the nine
+Added: months ended September 30, 2023.
The decrease was due to the Company having less cash on hand.
−Removed: a result, we incurred a net loss of $1,778,101 ($43.48 per share) for the six-month period ended June 30, 2024, compared to a net loss
−Removed: of $2,604,538 ($218.62 per share) for the six-month period ended June 30, 2023.
−Removed: Liquidity and Capital Resources
−Removed: As of June 30, 2024, we had cash and cash equivalents of $11,507,745.
−Removed: Net cash used in operating activities was $7,762,942
−Removed: during the six months ended June 30, 2024, compared to $5,628,146 during the six-month period ended June 30, 2023.
−Removed: The increase was a
−Removed: result of increased business activities by Nora Pharma.
−Removed: Cash flows used in investing activities were $1,210,944
−Removed: for the six months ended June 30, 2024, compared to $405,779 for the six months ended June 30, 2023.
−Removed: The increase was the result of cash
−Removed: invested in Nora Pharma to finance increase in inventory and expansion of product line.
−Removed: Cash flows provided by financing activities were
−Removed: $5,369,566 during the six months ended June 30, 2024, compared to $3,519,672 during the six months ended June 30, 2023.
−Removed: The increase was
−Removed: primarily a result of the approximately $10 million financing event completed in February 2024, compared to an approximately $5 million
−Removed: financing event completed in May 2023.
−Removed: We are not generating adequate revenues from our operations to fully
−Removed: implement our business plan as set forth herein.
−Removed: We believe our existing cash on hand will be sufficient to fund our pharmaceuticals sales
−Removed: operations and research and development activities for the next 24 months.
−Removed: There is no assurance our estimates will be accurate.
−Removed: have no committed sources of capital and we anticipate that we will need to raise additional capital in the future, including for further
−Removed: research and development activities and possibly clinical trials, as well as expansion of our generic pharmaceuticals operations.
−Removed: capital may not be available on terms acceptable to us, or at all.
−Removed: Critical Accounting Estimates
−Removed: The discussion and analysis of our financial condition and results
−Removed: of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted
−Removed: in the United States.
−Removed: The preparation of these financial statements requires us to make estimates and judgments that affect the amounts
−Removed: of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
−Removed: On an on-going basis, we evaluate
−Removed: our estimates based on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,
−Removed: the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent
−Removed: from other sources.
−Removed: Actual results may differ from these estimates under different assumptions or conditions.
−Removed: For a detailed list of significant accounting policies, please see
−Removed: our annual report on Form 10-K for the fiscal year ended December 31, 2023, including our financial statements and notes thereto included
−Removed: therein as filed with the SEC on March 28, 2024.
−Removed: Recently Adopted Accounting Standards
−Removed: In February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit
−Removed: Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No.
−Removed: 119 and Update
−Removed: to SEC Section on Effective Date Related to Accounting Standards Update No.
−Removed: 2016-02, Leases (Topic 842) which amends the effective date
−Removed: of the original pronouncement for smaller reporting companies.
−Removed: ASU 2016-13 and its amendments will be effective for the Company for interim
−Removed: and annual periods in fiscal years beginning after December 15, 2022.
−Removed: The Company believes the adoption will modify the way the Company
−Removed: analyzes financial instruments, but it does not anticipate a material impact on results of operations.
−Removed: The Company is in the process of
−Removed: determining the effects adoption will have on its consolidated financial statements.
−Removed: In August 2020, the FASB issued ASU 2020-06, Debt – Debt with
−Removed: Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815
−Removed: – 40), (“ASU 2020-06”).
−Removed: ASU 2020-06 simplifies the accounting for certain financial instruments with characteristics
−Removed: of liabilities and equity, including convertible instruments and contracts on an entity’s own equity.
−Removed: The ASU2020-06 amendments
−Removed: are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years.
−Removed: Early adoption is permitted,
−Removed: but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years.
−Removed: The Company is
−Removed: evaluating the impact of this guidance on its unaudited consolidated financial statements.
−Removed: Off Balance-Sheet Arrangements
−Removed: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
−Removed: We are a smaller reporting company and are not required to provide
−Removed: the information under this item.
+Added: As a result, we
+Added: incurred a net loss of $2,975,904 ($13.61 per share) for the nine-month period ended September 30, 2024, compared to a net loss of $3,256,020
+Added: ($265.71 per share) for the nine-month period ended September 30, 2023.
+Added: Liquidity and Capital
+Added: As of September
+Added: 30, 2024, we had cash and cash equivalents of $12,206,655.
+Added: Net cash used in
+Added: operating activities was $9,123,898 during the nine months ended September 30, 2024, compared to $6,085,435 during the nine-month period
+Added: ended September 30, 2023.
+Added: The increase was a result of increased business activities by Nora Pharma.
+Added: Cash flows used
+Added: in investing activities were $1,789,312 for the nine months ended September 30, 2024, compared to $386,920 for the nine months ended
+Added: September 30, 2023.
+Added: The increase was the result of cash invested in Nora Pharma to finance increase in inventory and expansion of operations
+Added: and product line.
+Added: Cash flows provided
+Added: by financing activities were $7,235,518 during the nine months ended September 30, 2024, compared to $3,456,106 during the nine months
+Added: ended September 30, 2023.
+Added: The increase was primarily a result of the approximately $10 million financing event completed in February
+Added: 2024, compared to an approximately $5 million financing event completed in May 2023.
+Added: We are not generating
+Added: adequate revenues from our operations to fully implement our business plan as set forth herein.
+Added: We believe our existing cash on hand
+Added: will be sufficient to fund our pharmaceuticals sales operations and research and development activities for the next 24 months.
+Added: is no assurance our estimates will be accurate.
+Added: We currently have no committed sources of capital and we anticipate that we will need
+Added: to raise additional capital in the future, including for further research and development activities and possibly clinical trials, as
+Added: well as expansion of our generic pharmaceuticals operations.
+Added: Additional capital may not be available on terms acceptable to us, or at
+Added: Critical Accounting
+Added: The discussion and
+Added: analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance
+Added: with accounting principles generally accepted in the United States.
+Added: The preparation of these financial statements requires us to make
+Added: estimates and judgments that affect the amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets
+Added: and liabilities.
+Added: On an on-going basis, we evaluate our estimates based on historical experience and on various other assumptions that
+Added: we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values
+Added: of assets and liabilities that are not readily apparent from other sources.
+Added: Actual results may differ from these estimates under different
+Added: assumptions or conditions.
+Added: For a detailed list
+Added: of significant accounting policies, please see our annual report on Form 10-K for the fiscal year ended December 31, 2023, including
+Added: our financial statements and notes thereto included therein as filed with the SEC on March 28, 2024.
+Added: Recently Adopted Accounting
+Added: We have adopted all new accounting standards impacting operations.
+Added: Off Balance-Sheet
+Added: AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
+Added: We are a smaller reporting company and
+Added: are not required to provide the information under this item.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.