You should read the following discussion and analysis of our financial condition
and results of operations in conjunction with the financial statements and the
related notes appearing elsewhere in this Quarterly Report on Form 10-Q. This
discussion contains forward-looking statements reflecting our current
expectations that involve risks and uncertainties. See our Annual Report on Form
10-K for the year ended
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains "forward-looking statements", within
the meaning of the
The forward-looking statements contained in this Quarterly Report on Form 10-Q include, among other things, statements about:
? our business strategies;
our ability to obtain regulatory approval of our product candidate and any
? other product candidates we may develop, and the labeling under any regulatory
approval we may obtain;
? risks relating to the timing and costs of clinical trials and the timing and
costs of other expenses;
? timing and likelihood of success of our clinical trials and regulatory approval
of our product candidates;
? risks associated with our reliance on third-party organizations;
? our competitive position;
? assumptions regarding the size of the available market, product pricing and
timing of commercialization of our product candidates, if approved;
? our intellectual property position and our ability to maintain and protect our
intellectual property rights;
? our results of operations, financial condition, liquidity, prospects, and
growth strategies;
? our cash needs and financing plans;
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? the industry in which we operate; and
? the trends that may affect the industry or us.
Overview
We are a development-stage biotechnology company focused on advancing novel combination antiviral therapies to treat diseases that we believe are associated with herpes virus activation, such as fibromyalgia ("FM"). Overactive immune response related to activation of tissue resident herpes virus has been postulated to be a potential root cause of chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and functional somatic syndrome, all of which are characterized by a waxing and waning manifestation of disease. While not completely understood, there is general agreement in the medical community that activation of the herpes virus is triggered by some form of environmental and/or health stressor. Our lead product candidate, IMC-1, is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. IMC-1 represents a novel combination antiviral therapy designed to synergistically suppress herpes virus activation and replication, with the end goal of reducing viral mediated disease burden.
IMC-1 combines two specific mechanisms of action purposely designed to inhibit
herpes virus activation and replication, thereby keeping the herpes virus in a
latent (dormant) state or "down-regulating" the herpes virus from a lytic
(active) state back to latency. The famciclovir component of IMC-1 inhibits
viral DNA replication and thus inhibits upregulation of the herpes virus. The
celecoxib component of IMC-1 inhibits cyclooxegenase-2 ("COX-2") and to a lesser
degree cyclooxegenase-1 ("COX-1"), enzymes used by the herpes virus to amplify
or accelerate its own replication. We are unaware of any other antivirals in
development for the treatment of FM with the goal of keeping tissue resident
herpes virus tissue in a latent state. We believe this novel approach was a
germane consideration in the
In
Our chronic toxicology studies in two species have also been completed as planned. These studies are required by regulatory authorities to support chronic administration of IMC-1 in future clinical studies, and the results from these studies will be an important element of the package we plan to submit to the FDA to facilitate our Phase 3 program discussions.
In
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evaluate changes in common Long COVID symptoms such as fatigue, sleep, attention, pain, autonomic function and anxiety. We expect the BHC to begin recruiting patients in the third quarter of 2022 for this study, with results expected in the first half of 2023.
We may face future business disruption and related risks resulting from the
ongoing outbreak of COVID-19 or from another pandemic, epidemic or outbreak of
an infectious disease, any of which could have a significant impact on our
business or delay the development of our drug candidates including the
enrollment or completion of our proposed clinical trials. Future emergence of
widespread health emergencies or pandemics could lead to new quarantines,
business shutdowns, disruptions to the healthcare system and overall economic
instability. If suppliers, clinical research organizations, clinical trial
sites, regulators, consultants and other third parties with whom we conduct
business were to experience shutdowns or other business disruptions, our ability
to enroll patients and conduct clinical trials in the manner and on the
timelines presently planned could be materially and negatively impacted. In
addition, the global economy, including credit and financial markets, has
experienced extreme volatility and disruptions, including severely diminished
liquidity and credit availability, declines in consumer confidence, declines in
economic growth, increases in unemployment rates, increases in inflation rates
and uncertainty about economic stability. For example, the current conflict
between
Results of Operations
Below is a summary of the results of operations:
Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Operating expenses: (Unaudited) (Unaudited) Research and development$ 2,406,438 $ 3,209,201 $ 5,175,540 $ 4,916,159 General and administrative 1,265,621 1,075,256 2,457,733 2,425,732 Total operating expenses$ 3,672,059 $ 4,284,457 $ 7,633,273 $ 7,341,891
Three and Six Months Ended
Research and Development Expenses
Research and development expenses decreased by
General and Administrative Expenses
General and administrative expenses increased by
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increases in expenses for salaries and related costs of
Liquidity and Capital Resources
Since our inception, we have financed our operations through a public offering
of common stock and proceeds from private placements of membership interests and
convertible promissory notes. To date, we have not generated any revenue from
the sale of products and we do not anticipate generating any revenue from the
sales of products for the foreseeable future. We have incurred losses and
generated negative cash flows from operations since inception. As of
Equity Financings
There were no equity financings during the six months ended
Debt Financings
There were no debt financing during the six months ended
Future Capital Requirements
We estimate our current cash of
We have no committed external sources of funds. Additional equity or debt financing or collaboration and licensing arrangements may not be available on acceptable terms, if at all.
As a result, substantial doubt exists regarding the Company's ability to continue as a going concern twelve months from the date the financial statements contained in this Quarterly Report on Form 10-Q were available to be issued.
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