Forward-Looking Statements
This Report contains certain forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 12E of the Securities
Exchange Act of 1934, including or related to our future results, certain
projections and business trends. Assumptions relating to forward-looking
statements involve judgments with respect to, among other things, future
economic, competitive and market conditions and future business decisions, all
of which are difficult or impossible to predict accurately and many of which are
beyond our control. When used in this Report, the words "estimate," "project,"
"intend," "believe," "expect" and similar expressions are intended to identify
forward-looking statements. Although we believe that assumptions underlying the
forward-looking statements are reasonable, any of the assumptions could prove
inaccurate, and we may not realize the results contemplated by the
forward-looking statement. Management decisions are subjective in many respects
and susceptible to interpretations and periodic revisions based on actual
experience and business developments, the impact of which may cause us to alter
our business strategy or capital expenditure plans that may, in turn, affect our
results of operations. In light of the significant uncertainties inherent in the
forward-looking information included in this Report, you should not regard the
inclusion of such information as our representation that we will achieve any
strategy, objective or other plans. The forward-looking statements contained in
this Report speak only as of the date of this Report as stated on the front
cover, and we have no obligation to update publicly or revise any of these
forward-looking statements. These and other statements which are not historical
facts are based largely on management's current expectations and assumptions and
are subject to a number of risks and uncertainties that could cause actual
results to differ materially from those contemplated by such forward-looking
statements. These risks and uncertainties include, among others, the failure to
successfully develop a profitable business, delays in identifying customers, and
the inability to retain a significant number of customers, as well as the risks
and uncertainties described in "Risk Factors" section to our Annual Report for
the fiscal year ended
When we use works like "we," "us", "our," the "company" and words of the like,
unless otherwise indicated, we are referring to the operations of us and our
wholly-owned subsidiary
Objective
The objective of our Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is to provide users of our financial statements with the following:
• A narrative explanation from the perspective of management of our financial
condition, results of operations, cash flows, liquidity and certain other factors that may affect future results;
• Useful context to the financial statements; and
• Information that allows assessment of the likelihood that past performance is
indicative of future performance.
Our MD&A is provided as a supplement to, and should be read together with, our
unaudited financial statements for the three months ended
Overview and Outlook
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During 2020 and continuing into 2021, Coeptis faced several operational challenges related to the COVID-19 global pandemic, which we continue to work to overcome. The launch of both 5050b2 products was impacted because of various COVID-19 limitations, most notably field sales personnel were not able to make healthcare provider visits in person; thereby limiting the awareness of the availability of these products. We explored and implemented several non-personal promotion efforts, but given the global limitations and dynamics, it was challenging to achieve expected sales.
In
The CD38 Agreements relate to two separate Vy-Gen drug product candidates, as follows:
CD38-GEAR-NK. This Vy-Gen drug product candidate is designed to protect CD38+ NK cells from destruction by anti-CD38 monoclonal antibodies, or mAbs. CD38-GEAR-NK is an autologous, NK cell-based therapeutic that is derived from a patient's own cells and gene-edited to enable combination therapy with anti-CD38 mAbs. We believe CD38-GEAR-NK possesses the potential to minimize the risks and side effects from CD38-positive NK cell fratricide.
Market Opportunity. We believe CD38-GEAR-NK could potentially revolutionize how CD38-related cancers are treated, by protecting CD38+ NK cells from destruction by anti-CD38 mAbs, thereby promoting the opportunity to improve the treatment of CD38-related cancers, including multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia.
Multiple myeloma is expected to be the first cancer indication targeted with
CD38-GEAR-NK. The global multiple myeloma market was
CD38-Diagnostic. This Vy-Gen product candidate is an in vitro diagnostic tool to analyze if cancer patients might be appropriate candidates for anti-CD38 mAb therapy. CD38-Diagnostic is an in vitro screening tool that provides the ability to pre-determine which cancer patients are most likely to benefit from targeted anti-CD38 mAb therapies, either as monotherapy or in combination with CD38-GEAR-NK. CD38-Diagnostic also has the potential to develop as a platform technology beyond CD38, to identify patients likely to benefit for broad range of mAb therapies across myriad indications.
Market Opportunity. We believe CD38-Diagnostic provides opportunity to make more cost-effective medical decisions for the treatment of B cell malignancies with high CD38 expression, including multiple myeloma, which may help to avoid unnecessary administration of anti-CD38 therapies. CD38-Diagnostic could prevent patients from being subjected to ineffective therapy and enable significant savings to healthcare systems.
CD38-Diagnostic could be offered as a companion diagnostic for determining patient suitability and likelihood of positive treatment outcomes for CD38-GEAR-NK and/or CD38 monoclonal antibody therapies.
GEAR-NK Product Overview. GEAR-NK is an autologous, gene-edited, natural killer cell-based therapeutic development platform that allows for modified NK cells to be co-administered with targeted mAbs, which, in the absence of the GEAR-NK, would otherwise be neutralized by mAb therapy.
Terms of the CD38 Agreements. In
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In the event that the promissory notes are timely paid by
Statera BioPharma. Coeptis executed a binding Letter of Intent (LOI) with Statera BioPharma, a clinical stage biopharmaceutical company developing immunotherapy via its proprietary AIMS platform. The LOI details a collaboration between the two companies for STAT-201, a product in development for Crohn's disease. Coeptis is to assist Statera BioPharma in its efforts to develop and commercialize STAT-201 in adult and pediatric populations. Coeptis is to receive development fees and commercial milestones under the to-be-completed definitive agreement.
STAT-201. STAT-201 is a lower dose version of an existing FDA approved product. STAT-201 has been granted Orphan Drug designation by the FDA which provides up to 7 years of market exclusivity upon approval. The safety profile of STAT-201 has been established and clinical studies have been previously conducted showing preliminary efficacy in Crohn's disease and other inflammatory diseases. A method of use patent was filed in 2011 and additional patents have been recently filed.
Development Strategy. Statera BioPharma is planning to initiate a 12-week, phase 3 clinical study in pediatric Crohn's patients by year-end 2021. Upon successful completion of the study, Statera BioPharma plans to file a new drug application (NDA) with the FDA. Additional studies intended to expand the indication to pediatric Crohn's disease are planned after approval.
Market Opportunity. There are many FDA approved products to treat Crohn's disease, including aminosalicylates, such as Azulfidine® and Asacol®, corticosteroids and biologics, such as Humira®. Some of the disadvantages of current therapies include: high cost, frequent dosing (up to 3 doses per day) and side effects ranging from upper respiratory infection, risk of other infections, decreased immune system function, and diarrhea. In initial studies, STAT-201 exhibited mild side effects including vivid dreams, dizziness and headaches. STAT-201 will be available as an oral tablet or capsule taken once per day.
CPT60621 - a focus on Parkinson's Disease. CPT60621 is a novel, ready to use,
easy to swallow, oral liquid version of an already approved drug used for the
treatment of Parkinson's Disease (PD). The currently approved dosage form is
only available as an oral solid tablet which can be difficult to swallow for
some PD patients. Per
PD affected nearly 1,000,000 people in the
Typical PD symptoms include thinking difficulties, uncontrolled shaking and tremors, loss of automatic movements, rigidity, and eating, speaking, and swallowing difficulties. During the course of their disease, nearly 80% of PD patients will develop a condition known as dysphagia which is defined as difficulty or discomfort in swallowing. Oral liquid dosage forms are easier to swallow than oral solid dosage forms. PD patients who suffer from dysphagia often must crush and dissolve tablets in juice in order to consume their medication. In more extreme cases, feeding tubes are utilized. This is costly to the healthcare system and is simply impractical.
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CPT60621 can be administered to the patient using an easy-to-use oral syringe, eliminating time consuming, costly, and uncontrolled tablet crushing. This novel dosage form, if approved, we believe will fulfill a market need and provide a beneficial treatment option for many PD patients.
To date, Coeptis has completed proof-of-concept formulation work for CPT60621 and performed a pilot bioequivalence study with passing results. We are currently targeting a 2022 NDA filing and 2023 commercial launch. We have yet to determine whether a commercial launch, assuming FDA approval of the product, will be performed through internal commercialization efforts, or by establishing out-licensing arrangements or other strategic relationships. Coeptis and Vici are currently in discussions as to how to maximize the value of CPT60621.
We expect to generate revenue from product sales and technology licensing. We cannot be certain of the timing of this revenue and will likely need funding to support continuing operations and support our growth strategy. We may have to finance operations by offering any combination of equity offerings, debt financing, collaborations, strategic alliances, or other licensing arrangements.
Our Results of Operations
Revenue. To date, we have generated minimal revenue mostly from consulting arrangements and product sales. Due to the COVID-19 global pandemic and the resulting market dynamics, it is uncertain if the current marketed products can generate sufficient sales to cover expenses. If our strategic business discussions progress to agreements, we expect to generate additional revenue from collaboration partners.
Operating Expenses. General and administrative expenses consist primarily of salaries and related costs for personnel and professional fees for consulting services related to regulatory, pharmacovigilance, quality, legal, and business development. We expect that our general and administrative expenses will increase in the future as we increase our headcount to support the business growth. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, insurance, and investor relation expenses associated with operating as a public company.
Research and developments costs will continue to be dependent on the strategic business collaborations and agreements will are anticipating in the future.
We expect development costs to increase to support our new strategic initiatives.
Comparison of the three months ended
Revenues. Revenues, which were generated from product sales of
Operating Expenses
Overview. Operating expenses increased from
The increase is mainly due to higher professional services fees, as well as new requirements for D&O insurance.
General and Administrative Expenses. For the three months ended
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Interest Expense. Interest expense was
Financial Resources and Liquidity. The Company had limited financial resources
during the twelve months ended
Comparison of the nine months ended
Revenues. Revenues, which were generated from consulting agreements of
Operating Expenses
Overview. Operating expenses increased from
General and Administrative Expenses. For the nine months ended
Interest Expense. Interest expense was
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