You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes included at the end of this report. This discussion and other parts of this report contain forward-looking statements that involve risks and uncertainties such as statements of our plans, objectives, expectations and intentions. As a result of many factors, including those factors set forth in the "Risk factors" section of this report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. The discussion and analysis of our financial condition and results of operations are based on Protagenic's financial statements, which Protagenic has prepared in accordance withU.S. generally accepted accounting principles. The preparation of these financial statements requires Protagenic to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, Protagenic evaluates such estimates and judgments, including those described in greater detail below. Protagenic bases its estimates on historical experience and on various other factors that Protagenic believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We expect to continue to incur significant expenses and minimal positive net cash flows from operations or negative net cash flows from operations for the foreseeable future, and those expenses and losses may fluctuate significantly from quarter-to-quarter and year-to-year. We anticipate that our expenses will fluctuate substantially as we:
? continue our ongoing preclinical studies, clinical trials and our product development activities for our pipeline of product candidates;
? seek regulatory approvals for any product candidates that successfully complete clinical trials;
? continue research and preclinical development and initiate clinical trials of our other product candidates;
? seek to discover and develop additional product candidates either internally or in partnership with other pharmaceutical companies;
? adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products;
? maintain, expand and protect our intellectual property portfolio; and
? incur additional legal, accounting and other expenses in operating as a public company.
44 Results of Operations
We are a development stage company currently performing clinical trials to
obtain
During the year endedDecember 31, 2021 , we incurred a loss from operations of$4,140,413 as compared to$2,551,611 for the year endedDecember 31, 2020 . The increase in the loss is due to an increase in research and development expense of$436,993 from$699,797 for the year endedDecember 31, 2020 to$1,136,790 for the year endedDecember 31, 2021 , and an increase in general and administrative expenses of$1,151,809 from$1,851,814 for the year endedDecember 31, 2020 to$3,003,623 for the year endedDecember 31, 2021 .
Liquidity and Capital Resources
Since our inception, we have incurred significant operating losses. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all. To date, we have primarily financed our operations through the public offering of our equity securities and the private placement of our convertible securities. InApril 2021 , we completed a public offering of our securities and uplisted to the Nasdaq Capital Market (the "Offering"). Pursuant to the Offering, we issued and sold 3,180,000 units at a public offering price of$4.15 Each unit consisted of one share of our common stock and one warrant, for a total of 3,180,000 shares of our common stock and 3,180,000 warrants to purchase up to an aggregate 3,180,000 shares of our common stock. Each warrant is exercisable to purchase one share of common stock at an exercise price of$4.98 per share (120% of the public offering price of the unit). The warrants are exercisable at any time from the date of issuance through the fifth anniversary of the date of issuance. The aggregate net proceeds receive by the Company from the Offering (before expenses) were$12.1 million . Upon the pricing of the Offering, our common stock was approved for listing on The Nasdaq Capital Market and commenced trading under the ticker symbol "PTIX" . At this time, our warrants were also approved for listing and commenced trading under the ticker symbol "PTIXW". InJune 2021 , theSEC declared effective a shelf registration statement filed by us. This shelf registration statement allows us to issue any combination of our common stock, preferred stock, debt securities, warrants, or units from time to time for an aggregate initial offering price of up to$100.0 million . InJuly 2021 , we entered into an At Market Issuance Agreement, or the ATM Agreement, withB. Riley Securities, Inc. and EF Hutton, division ofBenchmark Investments, LLC , or the Sales Agents, under which we may issue and sell from time to time up to$10.0 million of our common stock through or to the Sales Agents, as agent or principal. Any sale of shares of our common stock under the Sales Agreement will be made under our shelf registration statement on Form S-3. Sales of our common stock under the Sales Agreement are made at market prices by any method that is deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. The Company has not yet sold any shares under the ATM Agreement. Therefore, as ofDecember 31, 2021 ,$10.0 million of our common stock remained available for sale under the Sales Agreement. Operating activities used$2,798,614 and$1,348,779 in cash for the years endedDecember 31, 2021 and 2020, respectively. The use of cash in operating activities during the year endedDecember 31, 2021 , primarily comprised of$4,522,934 net loss,$1,518,756 in stock compensation expense, ($83,670 ) of change in the fair value of the derivative liability sinceDecember 31, 2020 , an increase in prepaid expenses and other current assets of ($480,510 ), amortization of debt discount of$427,137 , and a$340,121 increase of accounts payable and accrued expenses, which included payments to tax penalties, legal and accounting professionals, payments to consultants, and other administrative expenses.
Investing activities provided
We continually project anticipated cash requirements, predominantly from the ongoing funding requirements of our neuropeptide drug development program. The majority of these expenses relate to paying external vendors such as Contract Research Organizations (CROs) and peptide synthesizer companies. They could also include business combinations, capital expenditures, and new drug development working capital requirements. As ofDecember 31, 2021 , we had cash of$541,171 and working capital of$10,260,388 . We anticipate that losses will continue for the foreseeable future. Based on our current operating plans, we believe that our cash resources will be sufficient to fund its operations until approximately the end of the third quarter of 2023. In order to continue our operations beyond our forecasted runway we will need to raise additional capital, and we have no committed sources of additional capital at this time. The forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our expenses could vary materially and adversely as a result of a number of factors. We have based our estimates on assumptions that may prove to be wrong, and our expenses could prove to be significantly higher than we currently anticipate. Management does not know whether additional financing will be on terms favorable or acceptable to us when needed, if at all. If adequate additional funds are not available when required, or if we are unsuccessful in entering into partnership agreements for further development of our product candidates, management may need to curtail its development efforts and planned operations.
Contractual Obligations
The following table sets forth certain information concerning the future
contractual obligations under our convertible notes at
Payments due by period Less than More than Contractual obligations Total 1 year 1-3 years 3-5 years 5 years Long-Term PIK convertible notes payable$ 315,000 $ -$ 315,000 $ - $ - Long-Term PIK convertible notes payable- Related Party$ 200,000 $ -$ 200,000
$ - $ - Total$ 515,000 $ -$ 515,000 $ - $ - 45 Plan of Operations Business Overview The Company is in its developmental stage, with encouraging but not conclusive evidence that its lead drug candidate, PT00014, may be effective as an anti-anxiety and/or anti-depression drug. It is focused on confirming the efficacy of this drug candidate, along with performing the other preclinical steps needed to progress along the pathway to bring this drug candidate into human clinical trials and eventually, to the global market to provide a new pharmaceutical for patients suffering from anxiety or treatment-resistant depression. If we are able to successfully develop our drug, PT00114, and obtain FDA approval, we could then begin marketing and selling it inthe United States and generate revenue. FDA approval to begin commercial sales is the singular gating item that will allow us to begin generating sales revenue in theU.S. , so it will have an enormous impact on our business plan and our financial condition. It is anticipated that the sale of our drug will allow the Company to generate enough sales revenue to support all of our operations and to generate a profit. However, given the stage of development, even if FDA Approval is obtained, we do not anticipate generating any revenue from sales prior to 2025.
Development Milestones Currently Anticipated
Recent communications with the
? The Company in the process of refiling its IND application for PT00114
addressing the questions raised by regulators.
? Anticipate Q2 2022: Initiation of Phase I/IIa study for PT00114
Human Resources (current state of employees)
The Company has two part-time employees:Garo H. Armen , PhD, the Executive Chairman, andAlexander K. Arrow , MD, the Chief Financial Officer. The Company also has six paid consultants:Andrew Slee , PhD, Chief Operating Officer,Robert S. Stein , MD, PhD, Chief Medical Officer,Dalia Barsyte , PhD, Scientific Advisor,David Lovejoy , PhD, Scientific Advisor, andZack Armen , Strategic
Advisor. Financing Activities Financing activities provided$12,577,664 and$1,223,410 in cash for the years endedDecember 31, 2021 and 2020, respectively. The cash provided by financing consisted of$100,000 in proceeds from convertible notes, ($100,000 ) from the repayment of convertible notes,$327,125 from the exercise of warrants,$542,500 from the exercise of options, and$11,708,039 from the sale of shares and warrants, net of offering costs, for the year endedDecember 31, 2020 . The cash provided by financing consisted of$1,177,500 in proceeds from convertible notes,$150,000 in proceeds from convertible notes from related parties, and ($104,090 ) in payment of debt issuance costs of convertible notes for the year endedDecember 31, 2020 . 46
Off Balance Sheet Arrangements
We have no material off-balance sheet arrangements that are likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital resources, or capital expenditures.
Critical accounting policies and estimates
Our discussion and analysis of financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted inthe United States of America ("GAAP"). The notes to the consolidated financial statements contained in this Annual Report describe our significant accounting policies used in the preparation of the consolidated financial statements. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. We continually evaluate our critical accounting policies and estimates.
COVID-19
OnMarch 11, 2020 , theWorld Health Organization ("WHO") declared the Covid-19 outbreak to be a global pandemic. In addition to the devastating effects on human life, the pandemic is having a negative ripple effect on the global economy, leading to disruptions and volatility in the global financial markets. MostU.S. states and many countries have issued policies intended to stop or slow the further spread of the disease. Covid-19 and theU.S. response to the pandemic are significantly affecting the economy. There are no comparable events that provide guidance as to the effect the Covid-19 pandemic may have, and, as a result, the ultimate effect of the pandemic is highly uncertain and subject to change. We do not yet know the full extent of the effects on the economy, the markets we serve, our business, or our operations.
Recently Issued Accounting Pronouncements
None
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