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 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 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;
? 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;
? 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;
? the industry in which we operate; and
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? the trends that may affect the industry or us.
Overview
We are a development-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response such as fibromyalgia ("FM"). Overactive immune response related to activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") 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 HSV-1 is triggered by some form of environmental and/or health stressor. Our lead product, which we have named 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 HSV-1 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 HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or "down-regulating" HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA replication and thus inhibits upregulation of the HSV-1 virus. The celecoxib component of IMC-1 inhibits cyclooxegenase-2 ("COX-2") and to a lesser degree COX-1, enzymes used by HSV-1 to amplify or accelerate its own replication. We are unaware of any other antivirals in development for the treatment of FM specifically used to inhibit both HSV-1 activation and subsequent HSV-1 replication, with the goal of keeping tissue resident HSV-1 tissue in a latent state. We believe this novel approach was a germane consideration in FDA designating IMC-1 for fast-track review status for the treatment of FM. IMC-1 has also been granted a synergy patent based on the fact that neither of the individual components has proven effective in the management of fibromyalgia, yet the combination therapy generated a result that is greater than the sum of its parts.
Following our
We have contracted with the clinical research organization and other third-party
vendors to conduct the FORTRESS study which is planned to enroll approximately
460 patients aged 18 to 65, who will be randomized 1-to-1 either to IMC-1 or
placebo, all of whom have been diagnosed using the 2016
In addition, we have announced a collaboration with Dr.
We recognize the emergence of widespread health emergencies or pandemics, such as COVID-19, could have a significant impact on our business or delay the enrollment or completion of our proposed clinical trials, including the FORTRESS study. Currently, the trial sites we have selected to participate in the FORTRESS study are open, but future emergence of widespread health emergencies or pandamics could lead to new
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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 our clinical trial in the manner and on the timelines presently planned could be materially and negatively impacted. Although we currently believe the proposed FORTRESS study will enroll and be completed on time, we cannot guarantee that the COVID-19 pandemic or other widespread health emergencies will not have a material impact on our business or the timely completion of our clinical trials.
Results of Operations
Below is a summary of the results of operations:
Three Months Ended March 31, 2021 2020 Operating expenses: (Unaudited) Research and development$ 1,706,957 $ 30,539 General and administrative 1,350,476 352,014 Total operating expenses$ 3,057,433 $ 382,553
Three Months Ended
Research and Development Expenses
Research and development expenses increased by
General and Administrative Expenses
General and administrative expenses increased by
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 revenues from
the sale of products and we do not anticipate generating any revenues from the
sales of products for the foreseeable future. We have incurred losses and
generated negative cash flows from operations since inception. As of
The COVID-19 global pandemic has resulted in travel restrictions and temporary
shut-downs of both essential and non-essential businesses in the
16 Table of Contents Equity Financings
We closed our IPO on
Debt Financings
In 2020, we issued an aggregate of
Future Capital Requirements
We estimate our current cash of
To the extent that our capital resources are insufficient to meet our future operating and capital requirements, we will need to finance our cash needs through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. 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
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