0001104659-22-060806 | 10-Q | XBRL Viewer | Transcode Therapeutics INC

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Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2022	May 10, 2022
Document and Entity Information [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Mar. 31, 2022
Entity File Number	001-40363
Entity Registrant Name	TRANSCODE THERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	81-1065054
Entity Address State Or Province	MA
Entity Address, Address Line One	6 Liberty Square, #2382
Entity Address, City or Town	Boston
Entity Address, Postal Zip Code	02109
City Area Code	857
Local Phone Number	837-3099
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	RNAZ
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		12,977,234
Entity Central Index Key	0001829635
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q1
Amendment Flag	false

BALANCE SHEETS - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Current assets:
Cash	$ 16,852,626	$ 20,825,860
Prepaid expenses and other current assets	1,782,067	1,906,315
Total current assets	18,634,693	22,732,175
Fixed assets, net of depreciation	215,324	206,268
Total assets	18,850,017	22,938,443
Current liabilities:
Accounts payable and accrued expenses	1,825,641	2,503,569
Deferred grant income	23,538	30,528
Total current liabilities	1,849,179	2,534,097
Total liabilities	1,849,179	2,534,097
Commitments and contingencies (Note 8)
Stockholders' equity (deficit):
Preferred stock - $0.0001 par value; 10,000,000 shares authorized at March 31, 2022 and December 31, 2021; -0- shares issued and outstanding as March 31, 2022 and December 31, 2021
Common stock - $0.0001 par value, 290,000,000 shares authorized at March 31, 2022, and December 31, 2021; 12,977,234 and 12,904,574 shares issued and outstanding at March 31, 2022, and December 31, 2021, respectively	1,298	1,291
Additional paid-in capital	30,774,891	30,708,336
Accumulated deficit	(13,775,351)	(10,305,281)
Total stockholders' equity (deficit)	17,000,838	20,404,346
Total liabilities and stockholders' equity (deficit)	$ 18,850,017	$ 22,938,443

BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2022	Dec. 31, 2021
BALANCE SHEETS
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred Stock, Shares Authorized	10,000,000	10,000,000
Preferred Stock, Shares Issued	0	0
Preferred Stock, Shares Outstanding	0	0
Common stock, par value	$ 0.0001	$ 0.0001
Common Stock, Shares Authorized	290,000,000	290,000,000
Common Stock, Shares, Issued	12,977,234	12,904,574
Common Stock, Shares, Outstanding	12,977,234	12,904,574

STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended
STATEMENTS OF OPERATIONS - USD ($)	Mar. 31, 2022	Mar. 31, 2021
Operating expenses
Research and development	$ 1,881,576	$ 263,759
General and administrative	1,595,926	185,706
Total operating expenses	3,477,502	449,465
Operating loss	(3,477,502)	(449,465)
Other income (expense)
Change in fair value of derivative liabilities		(3,936,000)
Change in fair value of warrant liability		(47,115)
Grant income	6,990	0
Interest expense		(52,770)
Interest income	442	12
Total other income (expense)	7,432	(4,035,873)
Net loss	$ (3,470,070)	$ (4,485,338)
Weighted-average common shares outstanding, basic	12,977,234	4,636,216
Weighted-average common shares outstanding, diluted	12,977,234	4,636,216
Net loss per share, basic	$ (0.27)	$ (0.97)
Net loss per share, diluted	$ (0.27)	$ (0.97)

STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($)	Common Stock	Additional Paid-in Capital	Subscription Receivable	Accumulated Deficit	Total
Balance, beginning of period at Dec. 31, 2020	$ 464	$ 65,949	$ (12,763)	$ (3,461,882)	$ (3,408,232)
Balance, beginning of period (in shares) at Dec. 31, 2020	4,636,216
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss				(4,485,338)	(4,485,338)
Interest on subscription receivable		128	(128)		(128)
Share based compensation		48,431			48,431
Balance, end of period at Mar. 31, 2021	$ 464	114,508	$ (12,891)	(7,947,220)	(7,845,139)
Balance, end of period (in shares) at Mar. 31, 2021	4,636,216
Balance, beginning of period at Dec. 31, 2021	$ 1,291	30,708,336		(10,305,281)	20,404,346
Balance, beginning of period (in shares) at Dec. 31, 2021	12,904,574
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss				(3,470,070)	(3,470,070)
Exercise of stock options	$ 7	5,982			$ 5,989
Number of shares exercised	72,660				72,660
Share based compensation		60,573			$ 60,573
Balance, end of period at Mar. 31, 2022	$ 1,298	$ 30,774,891		$ (13,775,351)	$ 17,000,838
Balance, end of period (in shares) at Mar. 31, 2022	12,977,234

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

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STATEMENTS OF CASH FLOWS - USD ($)	3 Months Ended		12 Months Ended
STATEMENTS OF CASH FLOWS - USD ($)	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Cash flows from operating activities:
Net loss	$ (3,470,070)	$ (4,485,338)
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation	21,601	1,254
Share-based compensation expense	60,573	48,431
Change in fair value of derivative liabilities		3,936,000
Non-cash interest expense		19,633
Change in fair value of warrant liability		47,115
Changes in assets and liabilities:
Prepaid expenses and other current assets	124,248	(475,597)
Accounts payable and accrued expenses	(677,928)	353,211
Deferred grant income	(6,990)
Accrued interest on convertible promissory notes		33,138
Net cash used in operating activities	(3,948,566)	(522,153)
Cash flows from investing activities:
Purchase of equipment	(30,657)	(75,301)
Net cash used in investing activities	(30,657)	(75,301)
Cash flows from financing activities:
Proceeds from exercise of stock options	5,989
Payments of deferred offering costs		(131,600)
Net cash provided by (used in) financing activities	5,989	(131,600)
Net change in cash	(3,973,234)	(729,054)
Cash, beginning of period	20,825,860	828,016	$ 828,016
Cash, end of period	16,852,626	98,962	$ 20,825,860
Supplemental disclosure of cash flow
Interest	$ 4,425
Supplemental disclosure of non-cash investing and financing activities:
Accrued interest on subscriptions receivable		(128)
Deferred offering costs included in accounts payable and accrued expenses		$ 30,770

Nature of Business and Liquidity

3 Months Ended

Mar. 31, 2022

Nature of Business and Liquidity

Nature of Business and Liquidity

(1) Nature of Business and Liquidity

TransCode Therapeutics, Inc. (the “Company” or “TransCode”) was incorporated on January 11, 2016, under the laws of the State of Delaware. TransCode is a biopharmaceutical company focused primarily on developing and commercializing innovative drugs and diagnostics for treating and diagnosing cancer. TransCode is preparing for its first clinical trial. The Company’s lead therapeutic candidate, TTX-MC138, is an oligonucleotide conjugated to an iron oxide nanoparticle designed to be administered by infusion to inhibit the ability of metastatic tumor cells to survive. The goal of the therapy, if approved, is to achieve lifelong regression and long-term patient survival.

From its founding until mid-2021, the Company was engaged in organizational activities, including raising capital, and limited research and development (“R&D”) activities. On July 13, 2021, the Company completed the initial public offering (“IPO”) of its common stock raising $28.75 million in gross proceeds. Since the IPO, the Company has increased its R&D activities, hired additional employees, and begun more traditional operations.

The Company has not generated revenues and has not yet achieved profitable operations, nor has it ever generated positive cash flows from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. The Company is subject to those risks associated with any early-stage biopharmaceutical company that requires substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approvals, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital.

Following the IPO, the Company’s common stock commenced trading on the Nasdaq Capital Market under the ticker symbol “RNAZ”. The Company issued 7,187,500 shares of common stock in connection with the IPO, including exercise of the underwriter’s over-allotment option, at an initial offering price of $4.00 per share. The net proceeds from the IPO were approximately $25.4 million after deducting underwriting discounts, commissions and estimated offering expenses payable by the Company, including offering costs paid in 2020. In connection with the IPO, the Company also granted the underwriters warrants to purchase up to 312,500 shares of Company common stock at an exercise price of $5.00 per share (125% of the initial public offering price). Upon the closing of the IPO, outstanding convertible promissory notes converted into 1,068,135 shares of Company common stock.

Going Concern

These financial statements have been prepared under the assumption that the Company will continue as a going concern which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary course of business. Due to the Company’s recurring and expected continuing losses from operations, the Company has concluded there is substantial doubt concerning its ability to continue as a going concern within one year of the date of issuance of these financial statements without additional capital becoming available. These financial statements do not include any adjustments that might result from the outcome of this uncertainty.

To date, the Company has incurred substantial losses and negative cash flows from operations. It expects to continue to incur operating losses for the foreseeable future as it pursues development of its lead therapeutic candidate and other programs. Operating losses are expected to continue until such time, if ever, that the Company can generate significant revenue from product candidates currently in development. The Company is unable to predict the extent of any future losses or when the Company will become profitable, if ever.

For the three months ended March 31, 2022, net cash used in operating activities was $3.9 million and the Company’s net loss was $3.5 million. As of March 31, 2022, the Company had an accumulated deficit of $13.8 million and $16.9 million in cash.

The Company plans to expand development of its lead therapeutic candidate and other candidates, and explore strategic partnerships. Management believes that current cash is sufficient to fund operations and capital requirements into the first quarter of 2023, but does not believe that existing cash will be sufficient to fund requirements for a full 12 months from the date of these financial statements.

To support its planned expanded operations, the Company will require additional capital; however, the Company cannot be certain that additional funding will be available on acceptable terms, or at all. Through March 31, 2022, the Company’s primary source of capital was from the sale of convertible promissory notes and equity securities in the IPO. For the foreseeable future, the Company plans to fund its operations by continuing to raise additional capital, primarily through sales of equity or debt.

To the extent the Company raises additional funds by issuing equity securities, its stockholders may experience significant dilution. Any debt financing, if available, may include potentially dilutive features and include restrictive covenants that impact the Company’s ability to conduct business. If the Company is unable to raise additional capital when required or on acceptable terms, the Company may have to (i) significantly scale back its planned operations or (ii) relinquish or otherwise dispose of rights to technologies on unfavorable terms.

Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2022

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

(2) Summary of Significant Accounting Policies

(a) Basis of Presentation

The interim financial statements included herein are unaudited. These financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, these statements include all adjustments, consisting only of normal, recurring adjustments, necessary for a fair presentation of the financial position of TransCode Therapeutics, Inc. at March 31, 2022 and its results of operations and its cash flows for the three months ended March 31, 2022. The interim results of operations are not necessarily indicative of the results to be expected for a full year. These interim financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2021, and notes thereto contained in the Company’s Annual Report of Form 10-K, filed with the SEC. Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to such rules and regulations relating to interim financial statements.

(b) Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates.

Significant items subject to such estimates and assumptions include but are not limited to the valuation of share-based compensation, income from grants, and R&D expenses related to prepayments made to contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”). Future events and their effects cannot be predicted with certainty; accordingly, accounting estimates require the exercise of judgment. Accounting estimates used in the preparation of these financial statements change as new events occur, as more experience is acquired, as additional information is obtained and as the operating environment changes.

Basic net earnings (loss) per share is determined by dividing the net income (loss) attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted net earnings (loss) per share includes the effect, if any, from the potential conversion, vesting or exercise of securities (Contingent Securities) such as convertible promissory notes, stock options and warrants, if applicable, which would result in the issuance of additional shares of common stock. The computation of diluted net earnings (loss) per shares does not include the conversion or exercise of Contingent Securities when the effect of doing so would be antidilutive. Computations of the Company’s basic and diluted net earnings (loss) per share for the three months ended March 31, 2022 and 2021, are the same because the effect of including Contingent Securities was antidilutive.

(d) Cash

The Company classifies deposits in banks, money market funds and cash invested temporarily in various instruments with original maturities of three months or less as cash. At times, the Company’s cash balances in U.S. banks may exceed the levels of insured amounts under the Federal Deposit Insurance Corporation (FDIC). The Company’s cash balance at March 31, 2022, was $16,852,626.

(e) Fair Value of Financial Instruments

The Company’s financial instruments at March 31, 2022 and December 31, 2021, included cash, accounts payable, and accrued expenses. Cash is reported at fair value. The recorded carrying amount of accounts payable and accrued expenses reflect their fair value due to their short-term nature.

(f) Research and Development

Research and development costs are expensed as incurred and primarily comprise expenses to discover, research and develop therapeutic candidates. These expenses may include personnel costs, stock-based compensation expense, materials and supplies, allocated facility-related and depreciation expenses, third-party license fees, and costs under arrangements with third party vendors, such as CROs, CMOs, and consultants. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as expenses as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered. At March 31, 2022, and December 31, 2021, the Company’s outstanding payables to CROs or CMOs were $920,541 and $386,057, respectively.

The Company has entered into various research and development-related contracts with companies both inside and outside the United States. The related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company’s estimates.

Patent Costs

All legal fees and expenses and costs related to patent-related filings with governmental authorities incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. Other patent costs are classified as R&D expenses.

(g) Grant Income

Funds from grants are recognized as grant income in the statements of operations as and when earned for the specific research and development projects for which the grants are designated. Since there is no transfer of ownership of the work performed under the Award, and the Company does not lose control over the work performed under the Award, the Company deemed the Award funds as a contribution. Grant payments received are recorded as deferred grant income on the Company’s balance sheets until the related income has been earned. Grant income earned in excess of grant payments received is recorded as grant receivable on the Company’s balance sheets.

(h) Share-Based Compensation

Share based compensation, if any, for employees and non-employees is measured at the grant date based on the fair value of the award. The Company recognizes compensation expense, if any, for awards to employees and directors over the requisite service period, which is generally the vesting period of the respective award, and for awards to non-employees over the period during which services are rendered by such non-employees until completed. Generally, the Company issues awards with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company classifies stock-based compensation expense in its statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. Forfeitures are accounted for as they occur.

Because prior to the IPO, there was no public market for the Company’s common stock, the estimated fair value of the common stock was determined by the Company’s board of directors (the “Board”) as of the date of each award, with input from management, considering, when available, third-party valuations of the Company’s common stock as well as the Board’s assessment of additional objective and subjective factors that it believed were relevant and which may have changed between the date of the then most recent third-party valuation, if any, and the date of the grant. The assumptions used in calculating the fair value of share-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. As a result, if factors were to change and management were to use different assumptions, share-based compensation expense could be materially different. The fair value of awards made subsequent to the IPO will be determined using the closing price of the Company’s common stock on the date of grant.

Certain stock appraisal methodologies utilize, among other variables, the volatility of the stock price. As an historically private company, the Company lacked company-specific historical and implied volatility information for its stock. Therefore, it estimated its expected stock price volatility based on the historical volatility of publicly-traded peer companies and expects to continue to do so until such time, if ever, as it has adequate historical data regarding the volatility of its own publicly-traded stock price. The expected life of options awarded was estimated using the simplified method because the Company has limited historical information on which to base reasonable expectations about future exercise patterns and post-vesting employment. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on its common stock and does not expect to pay cash dividends in the foreseeable future.

(i) Property and Equipment

Property and equipment are recorded at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset as follows:


		Estimated useful life
Laboratory equipment		3 years
Furniture and fixtures		5 years
Computer and office equipment		3 years
Leasehold improvements		Shorter of the useful life or remaining lease term

When assets are retired or otherwise disposed of, the cost of assets disposed of and the related accumulated depreciation is removed from the accounts and any resulting gain or loss is included in the statements of operations in the period of disposal. Expenditures for repairs and maintenance are charged to expense as incurred.

(j) Income Taxes

The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. As of March 31, 2022, and December 31, 2021, the Company had a full valuation allowance against deferred tax assets.

The Company is subject to the provisions of ASC 740-10-25, “Income Taxes” (ASC 740). ASC 740 prescribes a more likely-than-not threshold for the financial statement recognition of uncertain tax positions. ASC 740 clarifies the accounting for income taxes by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.

There are currently no open Federal or State tax audits. The Company has not recorded any liability for uncertain tax positions at March 31, 2022, or December 31, 2021.

(k) Concentrations of Credit Risk

Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash. The Company generally maintains balances in various accounts at one or more U.S. banks in amounts that may exceed federally insured limits. The Company has not experienced any losses related to its cash and does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking balances.

(l) Emerging Growth Company Status

The Company is an “emerging growth company” (“EGC”) as defined in the Jumpstart Our Business Startups Act (“JOBS Act”) and may take advantage of certain exemptions from various reporting requirements that are applicable to public companies that are not EGCs. The Company may take advantage of these exemptions until it is no longer an EGC under Section 107 of the JOBS Act and has elected to use the extended transition period for complying with new or revised accounting standards. As a result of this election, the Company’s financial statements may not be comparable to companies that comply with public company Financial Accounting Standards Board (“FASB”) standards’ effective dates. The Company may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of a public offering or such earlier time that it is no longer an EGC.

(m) Recent Accounting Pronouncements

In November 2021, the FASB issued ASU No. 2021-10 entitled “Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance” (the “ASU”). This ASU will require enhanced disclosures related to the Company’s contracts with the U.S. Government that are accounted for by applying a grant or contribution accounting model by analogy. The new disclosure requirements include information about the nature of the transactions and the related accounting policy used to account for the transactions; the line items on the balance sheet and income statement that are affected by the transactions, and the amounts applicable to each financial statement line item; and significant terms and conditions of the transactions, including commitments and contingencies. The ASU is effective for annual periods beginning after December 15, 2021. The Company adopted this ASU on January 1, 2022, with no significant impact on the Company’s financial statements.

(n) Reverse Stock Split

On March 22, 2021, the Board and shareholders of the Company approved a reverse split of the Company’s common stock at a ratio of one share for every 1.6486484 shares previously held. All common stock share and per share data, and exercise price data for applicable common stock equivalents, included in these financial statements have been adjusted to reflect the reverse stock split.

Fair Value Measurements

3 Months Ended

Mar. 31, 2022

Fair Value Measurements

Fair Value Measurements

(3) Fair Value Measurements

ASC 820, “Fair Value Measurements”, provides guidance on the development and disclosure of fair value measurements. The Company follows this guidance for fair value measurements, which defines fair value, establishes a framework for measuring fair value under U.S. GAAP, and expands disclosures about fair value measurements. The guidance requires fair value measurements be classified and disclosed in one of the following three categories:

Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities.

Level 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data.

Level 3: Unobservable inputs which are supported by little or no market activity with values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.

Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of March 31, 2022, and December 31, 2021. The carrying amount of cash and accounts payable and accrued liabilities approximated fair value as they are short term in nature.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Prepaid Expenses and Other Current Assets

3 Months Ended

Mar. 31, 2022

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets

(4) Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following:


	March 31,		December 31,
	2022		2021
Prepaid operating expenses	$	92,525	$	61,459
Contract manufacturers and research organizations		962,793		441,593
Insurance premiums		717,339		1,393,853
Deposits		9,410		9,410
	$	1,782,067	$	1,906,315

Property and Equipment

3 Months Ended

Mar. 31, 2022

Property and Equipment

Property and Equipment

(5) Property and Equipment

Property and equipment, net consisted of the following:


	March 31,		December 31,
	2022		2021
Laboratory equipment	$	278,179	$	247,522
Less accumulated depreciation		(62,855)		(41,254)
Total property and equipment, net	$	215,324	$	206,268

Depreciation expense for the three months ended March 31, 2022 and 2021, was $21,601 and $1,254, respectively.

Accounts Payable and Accrued Expenses

3 Months Ended

Mar. 31, 2022

Accounts Payable and Accrued Expenses

Accounts Payable and Accrued Expenses

(6) Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consisted of the following:


	March 31,		December 31,
	2022		2021
Professional and general consulting fees	$	314,465	$	218,476
R&D expenses – CMOs, CROs, supplies, equipment and consulting		1,049,737		595,465
Operating expenses		150,473		256,463
Insurance premiums		237,590		945,928
Payroll and benefits		73,376		482,237
Accrued license payments		—		5,000
	$	1,825,641	$	2,503,569

See Note 8 for further information regarding the accrued license payments.

Deferred Grant Income

3 Months Ended

Mar. 31, 2022

Deferred Grant Income

Deferred Grant Income

(7) Deferred Grant Income

In April 2021, the Company received a Fast-Track Small Business Innovation Research, or SBIR, Award from the National Cancer Institute of the National Institutes of Health (the “NIH”). The Award is expected to provide $2,392,845 over three years to fund a two-phased research partnership between the Company and Massachusetts General Hospital. In May 2021, the Company received the first year funding of $308,861 which it recorded as deferred grant income. Income under the grant is recognized as work under the grant is completed. The Company recognized $6,990 and $0 of grant income for the three months ended March 31, 2022 and 2021, respectively. Deferred grant income was $23,538 and $30,528 as of March 31, 2022, and December 31, 2021, respectively.

Commitments and Contingencies

3 Months Ended

Mar. 31, 2022

Commitments and Contingencies.

Commitments and Contingencies

(8) Commitments and Contingencies

(a) Leases

In March 2021, the Company entered into an agreement with Massachusetts Biomedical Initiatives, Inc. (“MBI”) whereby the Company has subleased approximately 2,484 square feet of laboratory space with room for minor administrative functions. The Company may also use shared laboratory equipment at the facility. The monthly rental is $6,210 and the Company pays an additional amount for its allocated share of operating expenses currently assessed at $15 per square foot or $3,105 per month. The agreement is for one year, includes an option to extend the agreement upon the mutual agreement of the parties, and is cancelable anytime upon 90 days’ notice. In February 2022, the Company extended its agreement with Massachusetts Biomedical Initiatives, Inc. (“MBI”) through December 31, 2022. Beginning March 1, 2022, the Company’s base rent increased 5.0% to $6,521 per month while its share of operating expenses is expected to be approximately $3,261 per month, resulting in expected monthly rent totaling $9,781. In addition, in April 2022, the Company added the right to use cubicle space outside its laboratory area at an additional cost of $650 per month. As a result, the Company’s total commitment under the MBI agreement from April 1, 2022, through December 31, 2022, is $93,877.

(b) License Agreements

In November 2018, the Company licensed the exclusive rights to certain intellectual property to support development of its therapeutic candidates (“License”). The intellectual property licensed by the Company is owned by The General Hospital Corporation, d/b/a Massachusetts General Hospital, (“Licensor”). Payments by the Company under the license agreement included a one-time non-refundable fee of $50,000 paid after execution of the License; reimbursement of Licensor’s patent costs which, at execution of the License, were approximately $145,000; a minimum annual license fee of $25,000 payable within 60 days of each anniversary of the effective date of the License prior to the first commercial sale of a product or process covered by the License; milestone payments upon attainment of certain milestone events; royalties based on net sales of products covered by the patent-related rights; and a portion

of any sublicense income received by the Company. The Company is responsible for the development and commercialization of the licensed assets and for meeting certain milestones set forth in the License.

The milestone payments the Company shall pay to Licensor shall not exceed $1,550,000 based upon and subject to the attainment of each milestone event indicated below. These payments are generally due within 60 days of achievement of the milestone.


Milestone Event	Amount
Enrollment of first patient in a phase II clinical trial of a therapeutic product or process	$	100,000
Enrollment of first patient in a phase III clinical trial of a therapeutic product or process	$	200,000
First commercial sale of a therapeutic product or process	$	1,000,000
Filing of an application for regulatory approval of a clinical diagnostic product or process	$	100,000
First regulatory approval of a clinical diagnostic product or process	$	150,000

As of March 31, 2022, and December 31, 2021, no milestone events had been achieved.

In addition to milestone payments, royalties shall be paid to Licensor assessed on net sales of licensed products on a country-by-country basis in an amount equal to 3.0% for therapeutic products or processes and 6.0% for clinical diagnostic products and processes. The Company shall pay Licensor 30% of any and all sublicense income.

The Company has the right to terminate the License at any time by giving 90 days advance notice subject to the payment of any amounts due under the License at that time. The License may also be terminated for cause by either party upon the breach of the material obligations of the other party or the bankruptcy or liquidation of the other party. If the Company does not terminate the License, the term of the License shall continue until the latest of (i) the date on which all issued patents and filed patent applications subject to the License have expired or been abandoned; (ii) expiration of the last to expire regulatory exclusivity covering a covered product or process; or (iii) 10 years after the first commercial sale. The License requires the Company to make royalty payments beyond the term of the License at 1.5%.

In November 2020, the Company and Licensor amended the November 2018 license. Under the amendment, the intellectual property licensed in 2018 was categorized as “Patent Family 1” and a provisional patent filing related to the Company’s nanoparticle technology was added to Patent Family 1. A second patent family (“Patent Family 2”) was created which includes Licensor intellectual property targeting PD-L1.

The minimum annual license fee prior to the first commercial sale of a product or process covered by the License was increased from $25,000 per year to $30,000 per year for Patent Family 1 and a minimum annual license fee of $10,000 per year was added related to Patent Family 2. All other terms of the License including milestone payments, royalties and payment terms related to sublicense income received by the Company remain the same as in the original License.

Option Agreement

The Company signed an Exclusive Option And Internal Evaluation License Agreement (the “Option”) with the Licensor effective February 15, 2021. Under the Option, the Company has (1) the exclusive right to negotiate a license of a certain technology patented by the Licensor and (2) a non-exclusive internal evaluation license to allow the Company to evaluate the technology. The Option provided for a six-month term at a cost of $5,000 with a right to extend, upon the mutual agreement of the parties, for an additional six months for a second $5,000 payment. In August 2021, the Licensor agreed to extend the initial term of the Option until November 15, 2021, at no cost to the Company. Effective November 8, 2021, the Company and the Licensor agreed to extend the Option through May 22, 2022, at a cost to the Company of $5,000. The Company is also responsible for patent costs related to the subject technology incurred by Licensor during the Option period. Patent costs incurred by the Licensor prior to the effective date will not be reimbursed under the Option.

Accrued License Obligations

At March 31, 2022, and December 31, 2021, the Company had accrued $0 and $5,000, respectively, in license payments under the foregoing arrangements included in accounts payable and accrued expenses. The amount due at December 31, 2021, has subsequently been paid.

Prior to the IPO, the Company entered into employment agreements with its executive officers which became effective on completion of the IPO. The employment agreements provide the employee with, among other things, severance payments upon termination of the agreement by the Company for any reason other than for cause, death or disability or by the employee for good reason. The maximum aggregate severance payments under the agreements, which arise in the event of termination involving a Change of Control (as defined in the agreements), are approximately $2,412,000.

(d) Litigation

The Company may from time to time be subject to claims by others under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have a material adverse effect on the Company’s liquidity, financial condition, and cash flows. At March 31, 2022, and December 31, 2021, the Company did not have any pending legal actions.

(e) Indemnification Agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and executive officers that require the Company, among other things, to indemnify the parties against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any costs as a result of payments required by such indemnifications. The Company is not aware of any indemnification arrangements that could have a material adverse effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its financial statements, as of March 31, 2022, and December 31, 2021.

(f) Risks and Uncertainties

In December 2019, a novel strain of a virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes COVID-19, surfaced in Wuhan, China, and subsequently spread worldwide, including to Eastern Massachusetts where the Company’s primary office and laboratory space is located. The coronavirus pandemic is evolving, and to date has led to the implementation of various responses, including government-imposed quarantines, travel restrictions and other public health safety measures. The extent to which the coronavirus impacts the Company’s operations directly or through parties on whom it depends will depend on future developments, which are highly uncertain and cannot be predicted with confidence. The outcome of these events could delay the Company’s plans, increase its operating expenses and have a material adverse effect on its financial results.

In July 2021, the Company was subject to what it believes was a sophisticated computer-based phishing attack involving $526,435 of which $45,682 was recovered in five days while $480,753 was held by the receiving bank pending investigation and resolution. The latter amount was recovered in full on October 15, 2021. Management believes this incident had an immaterial impact on the Company’s financial condition and is reviewing its computer-related policies to implement additional defenses.

Stockholders' Equity (Deficit)

3 Months Ended

Mar. 31, 2022

Stockholders' Equity (Deficit)

Stockholders' Equity

(9) Stockholders’ Equity (Deficit)

(a) Overview

The Company’s Certificate of Incorporation, originally filed on January 11, 2016, was amended on April 15, 2020, to increase the number of shares of common stock authorized and to authorize the issuance of preferred stock. The Company’s Certificate of Incorporation was further amended and restated on April 27, 2021. The total number of shares which the Company is authorized to issue is 300,000,000, each with a par value of $0.0001 per share. Of these shares, 290,000,000 shall be common stock and 10,000,000 shall be preferred stock. At March 31, 2022, and December 31, 2021, the Company had issued and outstanding 12,977,234 and 12,904,574 shares of common stock outstanding. The preferred stock is undesignated; no shares of preferred stock have been issued.

The Company’s IPO was completed on July 13, 2021, in which it sold 7,187,500 shares at a public offering price of $4.00 per share. The gross proceeds from the IPO were $28,750,000 from which the Company paid $2,415,000 of underwriting commissions and expenses and $934,427 of other offering expenses. The underwriter also paid $100 in aggregate for the underwriter warrants issued in connection with the IPO. See Note 10.

(b) Common Stock

Dividends

Subject to the rights of holders of any preferred stock, holders of common stock are entitled to receive dividends as may be declared from time to time by the Board. No cash dividends were declared or paid during the three months ended March 31, 2022 or 2021, or at any other time through the date of these financial statements.

ii.

Liquidation

Subject to the rights of holders of any preferred stock as to liquidation, upon the liquidation, dissolution or winding up of the Company, the remaining assets of the Company will be distributed to holders of common stock.

iii.

Voting

Holders of common stock are entitled to one vote for each share of common stock held but shall not be entitled to vote on any amendment to the Certificate of Incorporation that relates solely to the terms of any series of preferred stock. There is no cumulative voting.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496158-112644

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496158-112644

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496171-112644

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496171-112644

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-URI http://asc.fasb.org/extlink&oid=120397183&loc=d3e187085-122770

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (d)
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496189-112644

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (g)
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496158-112644

Reference 8: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
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-Name Accounting Standards Codification
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-Publisher FASB
-Name Accounting Standards Codification
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-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Warrants

3 Months Ended

Mar. 31, 2022

Warrants

Warrants

(10) Warrants

In connection with the IPO, the Company granted the underwriters warrants to purchase up to 312,500 shares of Company common stock at an exercise price of $5.00 per share, which amount is 125% of the initial public offering price. The warrants have a five-year term and are not exercisable prior to January 9, 2022. All of the warrants were outstanding at March 31, 2022. The Company accounts for the warrants as a component of stockholders’ equity.

Share-Based Compensation

3 Months Ended

Mar. 31, 2022

Share-Based Compensation

Share-Based Compensation

(11) Share-Based Compensation

From inception through October 2018, the Company sold shares of restricted stock to co-founders, directors, managers, and advisors generally at prices believed to be fair market value at the time of the sale. Shares of restricted stock were reserved at the time of issue. To the extent that the sale price was less than the estimated fair market value at the grant date, a charge was recorded for the periods in which such shares vested. The vesting period for restricted stock was generally two to three years. Stock-based compensation in the year ended December 31, 2021, included $1,397 related to restricted stock. All shares of restricted stock had vested by December 31, 2021.

In April 2020, the Board approved the TransCode Therapeutics, Inc. 2020 Stock Option and Incentive Plan (the “2020 Plan”) providing for the issuance of options or other awards to purchase up to 3,032,787 shares of the Company’s common stock. The Board has determined not to make any further awards under the 2020 Plan following the closing of the IPO. In March 2021, the 2021 Stock Option and Incentive Plan (the “2021 Plan”) was approved by the Board and Company stockholders and became effective upon the effectiveness of the IPO. The 2021 Plan provides for the issuance of options or other awards to purchase up to 2,500,000 shares of the Company’s common stock, with possible annual increases of up to five percent of total shares outstanding at the prior December 31.

Both Plans provide for grants of equity in the form of stock awards, stock options and other instruments to employees, members of the Board, officers and consultants of and advisors to the Company. The Plans are administered by the Board or, at the discretion of the Board, by a committee of the Board. The amount and terms of grants are determined by the Board. The terms of options granted under the Plans generally are for ten (10) years after date of grant and are exercisable in cash or as otherwise determined by the Board. The vesting period for equity-based awards is determined at the discretion of the Board and is generally two to four years. If stock options granted under the 2021 Plan terminate, expire, or are surrendered or cancelled, the shares subject to such grants will again be available under the 2021 Plan.

The exercise price for incentive stock options is determined at the discretion of the Board but for grants to any person possessing less than 10% of the total combined voting power of all classes of stock may not have an exercise price less than 100% of the fair market value of the Common Stock on the grant date (110% for grants to any person possessing more than 10% of the total combined voting power of all classes of stock). The option term for incentive stock option awards may not be greater than ten years from the date of the grant (five years for grants to any person possessing more than 10% of the total combined voting power of all classes of stock).

In 2020 and 2021, the Board awarded options to purchase 1,792,672 shares of common stock under the 2020 Plan. Of the options issued under the 2020 Plan, options for 72,660 shares were exercised in January 2022 and options for 78,979 shares terminated in December 2021. In February and March 2022, the Board awarded options to purchase 259,000 shares of common stock at an exercise price of $2.45 per share, and 194,000 shares of common stock at an exercise price of $2.12 per share, respectively, under the 2021 Plan, all of which were outstanding at March 31, 2022.

At March 31, 2022, there were 1,108,208 options outstanding under the 2020 Plan that were vested and exercisable. As of December 31, 2021, there were 1,713,693 options outstanding, of which 1,042,534 were vested and exercisable. No options awarded under the 2021 Plan had vested at that date. Information about options to purchase common stock of the Company under both Plans is as follows:


		Weighted
		average		Weighted
		exercise		average
	Number of	price		contractual
	shares	per share		term (years)
Outstanding at December 31, 2020	1,756,279	$	0.25	5.9
Granted	36,393	$	3.91	5.5
Exercised	—		—	—
Forfeited	78,979		—	—
Outstanding at December 31, 2021	1,713,693	$	0.33	5.2
Granted	453,000	$	2.31	—
Exercised	72,660	$	0.08	—
Forfeited	—		—	—
Outstanding at March 31, 2022	2,094,033	$	0.77	6.2

The intrinsic value of the outstanding options as of March 31, 2022, was $4,423,866. The intrinsic value of vested options as of March 31, 2022 was $2,912,658.

Option valuation

The assumptions that the Company used to determine the grant-date fair value of options granted in the three months ended March 31, 2022 were as follows:


	Three months ended
	March 31, 2022
Risk-free interest rate	1.38% - 1.51	%
Expected term (in years)	3.5 - 6.0
Expected volatility	93.2	%
Expected dividend yield	—
Fair value per share of underlying stock	$2.45 - $2.12

The weighted average grant date fair value of the options granted in the three months ended March 31, 2022, was $1.86 per share.

The Company recorded share-based compensation expense of $60,573 and $48,431 during the three months ended March 31, 2022 and 2021, respectively. Share-based compensation in the three months ended March 31, 2022, was entirely related to stock options. The remaining share-based compensation expense to be recognized in the future is $955,671 over approximately 2.6 years.

Employee Stock Purchase Plan

3 Months Ended

Mar. 31, 2022

Employee Stock Purchase Plan

Employee Stock Purchase Plan

(12) Employee Stock Purchase Plan

In 2021, the Company adopted an Employee Stock Purchase Plan (the “ESPP”) to provide eligible employees of the Company with opportunities to purchase shares of the Company's common stock. The ESPP initially provided for the purchase of an aggregate of up to 150,000 shares of common stock. The number of shares of common stock available through the ESPP may be increased each year beginning in 2022 by up to 90,000 shares.

Net Loss Per Share

3 Months Ended

Mar. 31, 2022

Net Loss Per Share

Net Loss Per Share

(13) Net Loss Per Share

The Company reported net losses for the three months ended March 31, 2022 and 2021. Basic and diluted net loss per share attributable to common stockholders are the same for both periods because shares issuable in connection with Contingent Securities have been excluded from the computation of diluted weighted-average shares outstanding. The effect of their inclusion would have been antidilutive.

The following table sets forth the computation of basic and diluted loss per share:


	Three Months Ended
	March 31,
	2022		2021
Basic earnings (loss) per share
Numerator
Net income (loss)	$	(3,470,070)	$	(4,485,338)
Denominator
Weighted-average common shares outstanding		12,977,234		4,636,216
Net earnings (loss) per share	$	(0.27)	$	(0.97)

Income Taxes

3 Months Ended

Mar. 31, 2022

Income Taxes

Income Taxes

(14) Income Taxes

The Company’s income tax benefit (expense) was $0 for the three months ended March 31, 2022 and 2021. The Company has recorded a full valuation allowance against its net deferred tax assets as of March 31, 2022, and December 31, 2021, because the Company has determined that is it more likely than not that these assets will not be fully realized due to historic net operating losses

incurred. Accordingly, the benefit of the net operating loss that would have been recognized in the three months ended March 31, 2022 and 2021, was fully offset by changes in the valuation allowance.

As of March 31, 2022, and December 31, 2021, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operations.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 17
-Subparagraph (b)
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI http://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
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-URI http://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Related -Party Transactions

3 Months Ended

Mar. 31, 2022

Related -Party Transactions

Related -Party Transactions

(15) Related -Party Transactions

Between inception and mid-2018, major shareholders and co-founders funded certain expenses of the Company. The aggregate amount of these expenses, $35,685, was reimbursed by the Company during 2021.

On approximately April 26, 2021, three members of the Company’s management advanced an aggregate of $31,500 to the Company to enable it to pay certain Company IPO expenses. These advances were repaid in full, without interest, on May 13, 2021.

Subsequent Events

3 Months Ended

Mar. 31, 2022

Subsequent Events.

Subsequent Events

(16) Subsequent Events

For its financial statements as of March 31, 2022, the Company evaluated subsequent events through May 15, 2022, the date on which those financial statements were issued and concluded there are none for purposes of the financial statements.

Summary of Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2022

Summary of Significant Accounting Policies

Basis of Presentation

(a) Basis of Presentation

Use of Estimates

(b) Use of Estimates

Basic and Diluted Earnings (Loss) per Share

Cash and Cash Equivalents

(d) Cash

Fair Value of Financial Instruments

(e) Fair Value of Financial Instruments

Research and Development

(f) Research and Development

Patent Costs

Grant Income

(g) Grant Income

Share-Based Compensation

(h) Share-Based Compensation

Property and equipment

(i) Property and Equipment

Property and equipment are recorded at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset as follows:


		Estimated useful life
Laboratory equipment		3 years
Furniture and fixtures		5 years
Computer and office equipment		3 years
Leasehold improvements		Shorter of the useful life or remaining lease term

Income Taxes

(j) Income Taxes

There are currently no open Federal or State tax audits. The Company has not recorded any liability for uncertain tax positions at March 31, 2022, or December 31, 2021.

Concentrations of Credit Risk

(k) Concentrations of Credit Risk

Emerging Growth Company Status

(l) Emerging Growth Company Status

Recent Accounting Pronouncements

(m) Recent Accounting Pronouncements

Reverse Stock Split

(n) Reverse Stock Split

Summary of Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2022

Summary of Significant Accounting Policies

Summary of estimated useful life of property and equipment


		Estimated useful life
Laboratory equipment		3 years
Furniture and fixtures		5 years
Computer and office equipment		3 years
Leasehold improvements		Shorter of the useful life or remaining lease term

Prepaid Expenses and Other Current Assets (Tables)

3 Months Ended

Mar. 31, 2022

Prepaid Expenses and Other Current Assets

Schedule of prepaid expenses and other current assets


	March 31,		December 31,
	2022		2021
Prepaid operating expenses	$	92,525	$	61,459
Contract manufacturers and research organizations		962,793		441,593
Insurance premiums		717,339		1,393,853
Deposits		9,410		9,410
	$	1,782,067	$	1,906,315

Property and Equipment (Tables)

3 Months Ended

Mar. 31, 2022

Property and Equipment

Summary of property and equipment


	March 31,		December 31,
	2022		2021
Laboratory equipment	$	278,179	$	247,522
Less accumulated depreciation		(62,855)		(41,254)
Total property and equipment, net	$	215,324	$	206,268

Accounts Payable and Accrued Expenses (Tables)

3 Months Ended

Mar. 31, 2022

Accounts Payable and Accrued Expenses

Schedule of accounts payable and accrued expenses


	March 31,		December 31,
	2022		2021
Professional and general consulting fees	$	314,465	$	218,476
R&D expenses – CMOs, CROs, supplies, equipment and consulting		1,049,737		595,465
Operating expenses		150,473		256,463
Insurance premiums		237,590		945,928
Payroll and benefits		73,376		482,237
Accrued license payments		—		5,000
	$	1,825,641	$	2,503,569

Commitments and Contingencies (Tables)

3 Months Ended

Mar. 31, 2022

Commitments and Contingencies.

Schedule of milestone payments the Company shall pay to Licensor


Milestone Event	Amount
Enrollment of first patient in a phase II clinical trial of a therapeutic product or process	$	100,000
Enrollment of first patient in a phase III clinical trial of a therapeutic product or process	$	200,000
First commercial sale of a therapeutic product or process	$	1,000,000
Filing of an application for regulatory approval of a clinical diagnostic product or process	$	100,000
First regulatory approval of a clinical diagnostic product or process	$	150,000

Share-Based Compensation (Table)

3 Months Ended

Mar. 31, 2022

Share-Based Compensation

Summary of options activity


		Weighted
		average		Weighted
		exercise		average
	Number of	price		contractual
	shares	per share		term (years)
Outstanding at December 31, 2020	1,756,279	$	0.25	5.9
Granted	36,393	$	3.91	5.5
Exercised	—		—	—
Forfeited	78,979		—	—
Outstanding at December 31, 2021	1,713,693	$	0.33	5.2
Granted	453,000	$	2.31	—
Exercised	72,660	$	0.08	—
Forfeited	—		—	—
Outstanding at March 31, 2022	2,094,033	$	0.77	6.2

Assumptions for estimating the fair value of options


	Three months ended
	March 31, 2022
Risk-free interest rate	1.38% - 1.51	%
Expected term (in years)	3.5 - 6.0
Expected volatility	93.2	%
Expected dividend yield	—
Fair value per share of underlying stock	$2.45 - $2.12

Net Loss Per Share (Tables)

3 Months Ended

Mar. 31, 2022

Net Loss Per Share

Schedule of computation of basic and diluted net earnings (loss) per share


	Three Months Ended
	March 31,
	2022		2021
Basic earnings (loss) per share
Numerator
Net income (loss)	$	(3,470,070)	$	(4,485,338)
Denominator
Weighted-average common shares outstanding		12,977,234		4,636,216
Net earnings (loss) per share	$	(0.27)	$	(0.97)

Nature of Business and Liquidity (Details) - USD ($)	3 Months Ended
Nature of Business and Liquidity (Details) - USD ($)	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Nature of Business and Liquidity
Accumulated deficit	$ (13,775,351)		$ (10,305,281)
Cash	16,852,626		$ 20,825,860
Net cash used in operating activities	(3,948,566)	$ (522,153)
Net loss	$ (3,470,070)	$ (4,485,338)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

- Definition

The cumulative amount of the reporting entity's undistributed earnings or deficit.

+ References + Details

Nature of Business and Liquidity - IPO (Details) - USD ($) $ / shares in Units, $ in Thousands	Jul. 13, 2021	Mar. 31, 2022
Subsidiary, Sale of Stock [Line Items]
Warrants to purchase number of shares (in shares)		312,500
Exercise price		$ 5.00
IPO
Subsidiary, Sale of Stock [Line Items]
Price per share (in dollars per share)	$ 4.00
Shares issued (in shares)	7,187,500
Gross proceeds	$ 28,750
Net proceeds	$ 25,400
Warrants to purchase number of shares (in shares)	312,500
Exercise price	$ 5.00
Redemption premium (as a percent)	125.00%
Shares converted (in shares)	1,068,135

Summary of Significant Accounting Policies - Cash and Cash Equivalents (Details) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Summary of Significant Accounting Policies
Cash and cash equivalents	$ 16,852,626	$ 20,825,860

Summary of Significant Accounting Policies - Research and Development (Details) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Research and development
Outstanding payables	$ 1,825,641	$ 2,503,569
Research and Development Arrangement
Research and development
Outstanding payables	$ 920,541	$ 386,057

Summary of Significant Accounting Policies - Estimated useful life of property and equipment (Details)	3 Months Ended
	Mar. 31, 2022
Laboratory equipment
Property, Plant and Equipment [Line Items]
Estimated useful life	3 years
Furniture and fixtures
Property, Plant and Equipment [Line Items]
Estimated useful life	5 years
Computer and office equipment
Property, Plant and Equipment [Line Items]
Estimated useful life	3 years

Summary of Significant Accounting Policies - Additional Information (Details)	Mar. 22, 2021
Summary of Significant Accounting Policies
Reverse stock split ratio	1.6486484

Prepaid Expenses and Other Current Assets (Details) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Prepaid Expenses and Other Current Assets
Prepaid operating expenses	$ 92,525	$ 61,459
Contract manufacturers and research organizations	962,793	441,593
Insurance premiums	717,339	1,393,853
Deposits	9,410	9,410
Prepaid expenses and other current assets	$ 1,782,067	$ 1,906,315

Property and Equipment (Details) - USD ($)	3 Months Ended
Property and Equipment (Details) - USD ($)	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Property and Equipment
Property, Plant and Equipment, Gross	$ 278,179		$ 247,522
Less accumulated depreciation	(62,855)		(41,254)
Total property and equipment, net	215,324		$ 206,268
Depreciation, Depletion and Amortization	$ 21,601	$ 1,254

Accounts Payable and Accrued Expenses (Details) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Accounts Payable and Accrued Expenses
Professional and general consulting fees	$ 314,465	$ 218,476
R&D expenses - CMOs, CROs, supplies, equipment and consulting	1,049,737	595,465
Operating expenses	150,473	256,463
Insurance premiums	237,590	945,928
Payroll and benefits	73,376	482,237
Accrued license payments		5,000
Accounts Payable and Accrued Expenses	$ 1,825,641	$ 2,503,569

Deferred Grant Income (Details) - USD ($)	1 Months Ended	3 Months Ended
Deferred Grant Income (Details) - USD ($)	Apr. 30, 2021	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021	May 31, 2021
Deferred Grant Income
Expected Award amount	$ 2,392,845
Grant term (in years)	3 years
Grant income recognized		$ 6,990	$ 0
Deferred Grant Income		$ 23,538		$ 30,528	$ 308,861

Commitments and Contingencies (Details) - Massachusetts Biomedical Initiatives, Inc. ("MBI")	1 Months Ended
	Apr. 30, 2022 USD ($)	Feb. 28, 2022 USD ($)	Mar. 31, 2021 USD ($) ft²	Dec. 31, 2022 USD ($)
Lessee Disclosure [Abstract]
Real estate (in sq ft) \| ft²			2,484
Rent payments (per month)		$ 9,781	$ 6,210
Terms of agreement			1 year
Option to extend			true
Notice period for cancelation of lease			90 days
Percentage of increase in base rent		5.00%
Operating lease base rent per month		$ 6,521
Operating lease, expense		$ 3,261
Subsequent Events
Lessee Disclosure [Abstract]
Additional amount for allocated share of operating expenses per square foot	$ 650
Lease commitment				$ 93,877
Operating Expense
Lessee Disclosure [Abstract]
Rent payments (per month)			$ 3,105
Additional amount for allocated share of operating expenses per square foot			$ 15

Commitments and Contingencies - License Agreement (Details) - USD ($)			1 Months Ended					3 Months Ended
	Nov. 08, 2021	Feb. 15, 2021	Aug. 31, 2021	Jul. 31, 2021	Nov. 30, 2020	Oct. 31, 2020	Nov. 30, 2018	Mar. 31, 2022	Dec. 31, 2021
Loss Contingencies [Line Items]
One-time non-refundable fee of license agreement							$ 50,000
Reimbursement of Licensor's patent costs at execution of the License							145,000
Minimum annual license fee							$ 25,000
Period within each anniversary of the effective date of the License that minimum annual license fee must be paid							60 days
Maximum total milestone payments								$ 1,550,000
Period within which the milestone payments should be paid upon achievement of the milestone								60 days
Milestone payment due when enrollment of first patient in a phase II clinical trial of a therapeutic product or process								$ 100,000
Milestone payment due when enrollment of first patient in a phase III clinical trial of a therapeutic product or process								200,000
Milestone payment due when first commercial sale of a therapeutic product or process								1,000,000
Milestone payment due when filing of an application for regulatory approval of a clinical diagnostic product or process								100,000
Milestone payment due when first regulatory approval of a clinical diagnostic product or process								$ 150,000
Royalties calculated as a percentage to on net sales of licensed products for therapeutic products or processes								3.00%
Royalties calculated as a percentage to on net sales of licensed products for clinical diagnostic products and processes								6.00%
Royalties calculated as a percentage of any and all sublicense income								30.00%
Notice period for terminating License								90 days
Period after the first commercial sale that the License shall continue if not terminated by the company								10 years
Royalty percentage beyond the term of the License								1.50%
Minimum annual license fee for Patent Family 1					$ 30,000	$ 25,000
Minimum annual license fee related to Patent Family 2								$ 10,000
Cost of option agreement		$ 5,000
Terms of extended option agreement with Licensor			6 months
Cost of extended option agreement	$ 5,000	$ 5,000
Accrued License Obligations								0	$ 5,000
Computer-based phishing attack involving, amount				$ 526,435
Computer-based phishing attack involving recovery, amount				$ 45,682
Computer-based phishing attack involving recovery period				5 days
Computer based phishing attack, held by receiving bank pending resolution.				$ 480,753
Maximum \| Employee Severance
Loss Contingencies [Line Items]
Aggregate amount of severance								$ 2,412,000

Stockholders' Equity (Deficit) (Details) - USD ($)		3 Months Ended
Stockholders' Equity (Deficit) (Details) - USD ($)	Jul. 13, 2021	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021	Apr. 27, 2021
Class of Stock [Line Items]
Maximum number of shares which the Company is authorized to issue					300,000,000
Preferred stock, par value		$ 0.0001		$ 0.0001	$ 0.0001
Common stock, par value		$ 0.0001		$ 0.0001	$ 0.0001
Accumulated restricted common stock issued		12,977,234		12,904,574
Accumulated restricted common stock outstanding		12,977,234		12,904,574
Preferred stock, shares issued		0		0
Common Stock, Number of Shares, Par Value and Other Disclosures [Abstract]
Cash dividends were declared or paid		$ 0	$ 0
Common stock voting rights per share		$ 1
IPO
Class of Stock [Line Items]
Shares issued (in shares)	7,187,500
Price per share (in dollars per share)	$ 4.00
Gross proceeds from issuance	$ 28,750,000
Underwriting commissions	2,415,000
Other offering expenses	934,427
Proceeds from Issuance of Warrants	$ 100
Common Stock
Class of Stock [Line Items]
Maximum number of shares which the Company is authorized to issue					290,000,000
Preferred Stock
Class of Stock [Line Items]
Maximum number of shares which the Company is authorized to issue					10,000,000

Warrants (Details)	Mar. 31, 2022 $ / shares shares
Warrants
Number of warrants purchased \| shares	312,500
Exercise price \| $ / shares	$ 5.00
Underwriter Initial public offering price (in percentage)	125.00%
Underwriter warrants term	5 years

Share-Based Compensation (Details) - USD ($)	3 Months Ended		12 Months Ended
Share-Based Compensation (Details) - USD ($)	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based compensation expense	$ 60,573	$ 48,431
Restricted Stock
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based compensation expense			$ 1,397
Minimum \| Restricted Stock
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	2 years
Maximum \| Restricted Stock
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	3 years
Stock Option and Incentive Plan 2020 \| Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	2 years
Stock Option and Incentive Plan 2020 \| Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	4 years

Share-Based Compensation - Additional Information (Details)	1 Months Ended			3 Months Ended	12 Months Ended
	Mar. 31, 2022 $ / shares shares	Feb. 28, 2022 $ / shares shares	Dec. 31, 2021 shares	Mar. 31, 2022 $ / shares shares	Dec. 31, 2021 shares	Jan. 31, 2022 shares	Dec. 31, 2020 shares	Apr. 30, 2020 shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares approved for issuance of options						72,660
Number of shares exercised				72,660
Number of shares terminated			78,979		78,979
Options awarded during period				453,000	36,393
Significant shareholder threshold used for determining exercise price				10.00%
Exercise price as a percentage of fair value				100.00%
Exercise price as a percentage of fair value for shareholders owning specified minimum amount				110.00%
Option terms for shareholders owning specified minimum amount				5 years
Stock Option and Incentive Plan 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares approved for issuance of options								3,032,787
Terms of award				10
Stock Option and Incentive Plan 2020 \| Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period				2 years
Stock Option and Incentive Plan 2020 \| Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period				4 years
Stock Option and Incentive Plan 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares approved for issuance of options	2,500,000			2,500,000
Percentage of possible annual increases of total shares outstanding				5
Number of shares exercised	194,000
Exercise price per share \| $ / shares	$ 2.12	$ 2.45		$ 2.12
Options \| Stock Option and Incentive Plan 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares approved for issuance of options			1,792,672		1,792,672		1,792,672
Options available for future grants	1,108,208		1,713,693	1,108,208	1,713,693
Options vested and exercisable			1,042,534		1,042,534
Options \| Stock Option and Incentive Plan 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares exercised		259,000

Share-Based Compensation - Information About Options to Purchase Common Stock (Details) - USD ($)	1 Months Ended	3 Months Ended	12 Months Ended
	Dec. 31, 2021	Mar. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Number of shares
Outstanding, beginning balance		1,713,693	1,756,279
Granted		453,000	36,393
Exercised		72,660
Forfeited	78,979		78,979
Outstanding, ending balance	1,713,693	2,094,033	1,713,693	1,756,279
Weighted average exercise price per share
Outstanding, beginning balance		$ 0.33	$ 0.25
Granted		2.31	3.91
Exercised		0.08
Outstanding, ending balance	$ 0.33	$ 0.77	$ 0.33	$ 0.25
Weighted average contractual term (years)
Weighted average contractual term (years)		6 years 2 months 12 days	5 years 2 months 12 days	5 years 10 months 24 days
Granted			5 years 6 months
Intrinsic value of the outstanding options		$ 4,423,866
Intrinsic value of the Vested options		$ 2,912,658

Share-Based Compensation - Grant-date Fair Value of Options Granted (Details) - Options	3 Months Ended
	Mar. 31, 2022 $ / shares
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Expected volatility	93.20%
Weighted average grant date fair value of the options granted	$ 1.86
Minimum
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Risk-free interest rate	1.38%
Expected term (in years)	3 years 6 months
Fair value per share of underlying stock	$ 2.12
Maximum
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Risk-free interest rate	1.51%
Expected term (in years)	6 years
Fair value per share of underlying stock	$ 2.45

Share-Based Compensation - Stock-based Compensation Expense (Details) - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Share-Based Compensation
Share-based compensation expense	$ 60,573	$ 48,431
Remaining unrecognized stock-based compensation expense	$ 955,671
Period for recognition of stock-based compensation expense	2 years 7 months 6 days

Employee Stock Purchase Plan (Details)	12 Months Ended
Employee Stock Purchase Plan (Details)	Dec. 31, 2021 shares
Employee Stock Purchase Plan
Shares Issued on ESPP	150,000
Shares available in ESPP	90,000

Net Loss Per Share - Schedule of Computation of Basic And Diluted Net Earnings (Loss) Per Share (Details) - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Numerator
Net loss	$ (3,470,070)	$ (4,485,338)
Denominator
Weighted-average common shares outstanding, basic	12,977,234	4,636,216
Weighted-average common shares outstanding, diluted	12,977,234	4,636,216
Net earnings (loss) per share attributable to common stockholders, basic	$ (0.27)	$ (0.97)
Net earnings (loss) per share attributable to common stockholders, diluted	$ (0.27)	$ (0.97)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

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The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

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The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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Income Taxes (Details) - USD ($)	3 Months Ended		12 Months Ended
Income Taxes (Details) - USD ($)	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Income Taxes
Income tax benefit (expense)	$ 0	$ 0
Accrued interest or penalties related to uncertain tax positions	0		$ 0
Interest or penalties related to uncertain tax positions recognized in the Company's statements of operations	$ 0		$ 0

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Related -Party Transactions (Details) - Major shareholders and co-founders - USD ($)	Dec. 31, 2021	Apr. 26, 2021
Related party transactions
Due to related parties	$ 35,685
IPO
Related party transactions
Due to related parties		$ 31,500

- Definition

Carrying amount as of the balance sheet date of obligations due all related parties. For classified balance sheets, represents the current portion of such liabilities (due within one year or within the normal operating cycle if longer).

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