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 December 31, 2020 filed with the Security and Exchange Commission ("SEC") on March 23, 2021 (the "2020 Annual Report on Form 10-K"), under "Risk Factors", available on the SEC EDGAR website at www.sec.gov, for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under "Risk Factors" and elsewhere in this Quarterly Report on Form 10-Q.



              CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing," "plan," "predict," "project," "potential," "should," "will," or "would," and or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain.

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 December 2020 IPO, we have been focused on preparing to execute on our key research programs, including our Phase 2b trial in FM and our chronic toxicology program to enable long-term dosing of IMC-1. Our Phase 2b clinical trial in FM will henceforth be known as the FORTRESS study and stands for Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1. During the period covered by this Quarterly Report on Form 10-Q, we started the refinement of the IMC-1 manufacturing program so that ample drug and matching placebo will be available to start our programs with dosing projected in the second quarter of this year.

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 American College of Rheumatology diagnostic criteria for fibromyalgia. The primary endpoint for this trial will focus on reduction in pain over time. Pain reduction will be measured daily by the NRS 24-hour recall scale via an electronic diary that the patient will use at home. In addition to assessing the fibromyalgia patients pain reduction; we will also assess IMC-1's ability to improve symptoms of fatigue, sleep disturbance, improvements in overall global health status and improved patient function. We project to begin enrolling patients in the second quarter of this year.

In addition, we have announced a collaboration with Dr. Michael Camilleri at the Mayo Clinic to explore the role of antiviral therapy in managing IBS. The first step in the collaboration is focused on designing a phase 2 proof of concept study to treat the pain associated with IBS, with a longer-term goal of conducting the phase 2 study.

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 March 31, 2021 and 2020

Research and Development Expenses

Research and development expenses increased by $1.68 million to $1.71 million for the three months ended March 31, 2021 from $0.03 million for the three months ended March 31, 2020 due to increases in expenses for clinical trials of $0.83 million, toxicology studies of $0.34 million, salaries and related costs of $0.27 million, and drug development and manufacturing costs of $0.24 million.

General and Administrative Expenses

General and administrative expenses increased by $1.0 million to $1.35 million for the three months ended March 31, 2021 from $0.35 million for the three months ended March 31, 2020 due to increases in expenses for salaries, benefits and compensation costs of $0.2 million, legal and accounting fees of $0.3 million and other costs associated with being a public company of $0.6 million offset by a decrease in business development costs of $0.1 million.

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 March 31, 2021, our principal source of liquidity was our cash, which totaled $24.6 million.

The COVID-19 global pandemic has resulted in travel restrictions and temporary shut-downs of both essential and non-essential businesses in the U.S. and abroad. To date, the pandemic has not had a material impact on our operations as our employees are presently working from home. Fibromyalgia research and development activities have largely progressed as planned during the pandemic. However, due to many uncertainties, we are unable to estimate the pandemic's forward, if any, at this time.





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Equity Financings

We closed our IPO on December 21, 2020, raising gross proceeds of $34.5 million and net proceeds of approximately $31.1 million, after deducting underwriting discounts, commissions and offering expenses.

Debt Financings

In 2020, we issued an aggregate of $2.0 million principal amount of convertible promissory notes. At the Corporate Conversion, these notes converted to common interests at the price of $400,000 per 1% of common interests. There was no debt outstanding for the year ended December 31, 2020.

Future Capital Requirements

We estimate our current cash of $24.6 million at March 31, 2021 is sufficient to fund our operations and capital requirements through the end of 2022. We believe that these available funds will be sufficient to complete our Phase 2b clinical trial for IMC-1 and commence the planning of our Phase 3 study in FM for this product candidate. However, it is difficult to predict our spending for our product candidate prior to obtaining FDA approval. Moreover, changing circumstances may cause us to expend cash significantly faster than we currently anticipate, and we may need to spend more cash than currently expected because of circumstances beyond our control.

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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