0001493152-22-013523 | 10-Q | XBRL Viewer | Aerovate Therapeutics INC

BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES

(2) BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

(a)

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements as of March 31, 2022 and for the three months ended March 31, 2022 and 2021 have been prepared in conformity with generally accepted accounting principles (“GAAP”) in the United States of America for interim financial information and pursuant to Article 10 of Regulation S-X of the Securities Act of 1933, as amended (the Securities Act). Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. These unaudited condensed consolidated financial statements include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows.

The results for the three months ended March 31, 2022 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period. The condensed consolidated balance sheet as of December 31, 2021 has been derived from the audited financial statements at that date but does not include all disclosures required by GAAP for complete financial statements. Because all of the disclosures required by GAAP for complete financial statements are not included herein, these unaudited condensed consolidated financial statements and the notes accompanying them should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2021. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

Reverse Stock Split

	*(b)*	*Reverse Stock Split*

On June 22, 2021, the Company effected a 1-for-3.1060103 reverse stock split (the “Reverse Stock Split”) of its issued and outstanding common stock. Accordingly, the conversion ratio for the Company’s outstanding convertible preferred stock was proportionately adjusted such that the common stock issuable upon conversion of such preferred stock was decreased in proportion to the Reverse Stock Split. The par value of the common stock was not adjusted as a result of the Reverse Stock Split. All references to common stock, options to purchase common stock, early exercised options, share data, per share data, convertible preferred stock (to the extent presented on an as-converted to common stock basis) and related information contained in these financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented.

Use of Estimates

(c)

Use of Estimates

The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Reported amounts and note disclosures reflect the overall economic conditions that are most likely to occur and anticipated measures management intends to take. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations, and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it, as well as the economic impact on local, regional, national and international markets. Actual results could differ materially from those estimates. Accounting estimates and management judgements reflected in the consolidated financial statements include: normal recurring accruals, including the accrual for research and development expenses, stock-based compensation and fair value of investments. Estimates and assumptions are reviewed quarterly. Any revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

Net Loss Per Share

(d)

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration of potential dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the sum of the weighted average number of common shares plus the potential dilutive effects of potential dilutive securities outstanding during the period. Potential dilutive securities are excluded from diluted earnings or loss per share if the effect of such inclusion is antidilutive. The Company’s potentially dilutive securities, which include convertible preferred stock prior to the conversion of such shares to common stock and outstanding stock options under the Company’s equity incentive plan, have been excluded from the computation of diluted net loss per share as they would be anti-dilutive to the net loss per share. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.

The following table summarizes the Company’s net loss per share (in thousands, except share and per share amounts):

SCHEDULE OF NET LOSS PER SHARE

	2022			2021
	Three Months Ended March 31,
	2022			2021
Numerator:
Net loss	$	(10,910	)	$	(2,781	)
Accretion of Series A redeemable convertible preferred stock to redemption value		-			(13	)
Net loss available to common stockholders	$	(10,910	)	$	(2,794	)

Denominator:
Weighted-average common stock outstanding, basic and diluted		24,410,393			243,076
Net loss per share, basic and diluted	$	(0.45	)	$	(11.49	)

Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would have had an anti-dilutive effect are as follows (in common stock equivalent shares):

	As of March 31,
	2022		2021
Options to purchase common stock		3,703,931		229,105
Series Seed redeemable convertible preferred stock		-		1,287,825
Series A redeemable convertible preferred stock		-		3,449,369
		3,703,931		4,966,299

FAIR VALUE OF FINANCIAL INSTRUMENTS

3 Months Ended

Mar. 31, 2022

Fair Value Disclosures [Abstract]

FAIR VALUE OF FINANCIAL INSTRUMENTS

(3) FAIR VALUE OF FINANCIAL INSTRUMENTS

The following tables summarize the Company’s financial assets measured at fair value on a recurring basis and their respective input levels based on the fair value hierarchy (in thousands):

SCHEDULE OF FAIR VALUE INSTRUMENTS

	March 31, 2022		Quoted Prices in Active Markets for Indentical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (level 3)
			Fair Value Measurements Using
	March 31, 2022		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (level 3)
Assets:
Cash equivalents
Money market funds		12,736		12,736		-		-
Commercial paper		11,090		-		11,090		-
Total cash equivalents		23,826		12,736		11,090		-

Short-term investments
U.S. Treasury bills		32,319		32,319		-		-
Corporate debt securities		7,631		-		7,631		-
Commercial paper		92,985		-		92,985		-
Total short-term investments		132,935		32,319		100,616		-

Total	$	156,761	$	45,055	$	111,706	$	-

	December 31, 2021		Quoted Prices in Active Markets for Indentical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (level 3)
			Fair Value Measurements Using
	December 31, 2021		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (level 3)
Assets:
Cash equivalents
Money market funds	$	39,653	$	39,653	$	-	$	-
Commercial paper		14,448		-		14,448		-
Total cash equivalents		54,101		39,653		14,448		-

Short-term investments
U.S. Treasury bills		25,135		25,135		-		-
Corporate debt securities		10,715		-		10,715		-
Commercial paper		77,328		-		77,328		-
Total short-term investments		113,178		25,135		88,043		-

Total	$	167,279	$	64,788	$	102,491	$	-

Cash Equivalents and Short-Term Investments

Financial assets measured at fair value on a recurring basis consist of the Company’s cash equivalents and short-term investments. Cash equivalents consisted of money market funds and commercial paper, and short-term investments consisted of U.S. Treasury bills, corporate debt securities and commercial paper. The Company obtains pricing information from its investment manager and generally determines the fair value of investment securities using standard observable inputs, including reported trades, broker/dealer quotes, and bids and/or offers.

The following tables summarize the Company’s short-term investments (in thousands):

SUMMARY OF SHORT TERM INVESTMENT

		As of March 31, 2022
	Maturity	Amortized cost		Gross unrealized gains		Gross unrealized losses			Estimated fair value
Corporate debt securities	1 year or less	$	7,650	$	-	$	(18	)	$	7,632
Commercial paper	1 year or less		93,256		-		(272	)	$	92,984
U.S. Treasury bills	2 years or less		32,673		-		(354	)	$	32,319
		$	133,579	$	-	$	(644	)	$	132,935

		As of December 31, 2021
	Maturity	Amortized cost		Gross unrealized gains		Gross unrealized losses			Estimated fair value
Corporate debt securities	1 year or less	$	10,726	$	-	$	(11	)	$	10,715
Commercial paper	1 year or less		77,328		9		(9	)		77,328
U.S. Treasury bills	2 years or less		25,183		-		(48	)		25,135
		$	113,237	$	9	$	(68	)	$	113,178

The Company considers whether unrealized losses have resulted from a credit loss or other factors. The unrealized losses on the Company’s available-for-sale securities as of March 31, 2022 and December 31, 2021 were caused by fluctuations in market value and interest rates as a result of the economic environment and not credit risk. The Company concluded that an allowance for credit losses was unnecessary as of March 31, 2022 and that there were no impairments as of December 31, 2021. It is neither management’s intention to sell nor is it more likely than not that the Company will be required to sell these investments prior to recovery of their cost basis or recovery of fair value. Unrealized gains and losses are included in accumulated other comprehensive loss. The Company excludes accrued interest from both the fair value and the amortized cost basis of the available-for-sale debt securities for the purposes of identifying and measuring an impairment and to not measure an allowance for expected credit losses for accrued interest receivables. Accrued interest receivable is written off through net realized investment gains (losses) at the time the issuer of the bond defaults or is expected to default on payment. It is the Company’s policy to present the accrued interest receivable balance as part of prepaid expenses and other current assets in the balance sheets. Accrued interest receivable related to short-term investments was $0.1 million as of March 31, 2022 and December 31, 2021.

Organization, Consolidation and Presentation of Financial Statements [Abstract]

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

BALANCE SHEET COMPONENTS

3 Months Ended

Mar. 31, 2022

BALANCE SHEET COMPONENTS

(4) BALANCE SHEET COMPONENTS

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):

	March 31,		December 31,
	2022		2021
Prepaid research and development	$	3,628	$	5,233
Prepaid expenses		896		1,485
Other current assets		289		240
Total prepaid expenses and other current assets	$	4,813	$	6,958

Accrued and Other Current Liabilities

Accrued and other current liabilities consisted of the following (in thousands):

March 31, December 31,

2022 2021

Accrued research and development $ 1,019 $ 217

Accrued payroll and other employee benefits 387 790

Other 241 143

Total accrued and other current liabilities $ 1,647 $ 1,150

COMMITMENTS AND CONTINGENCIES

3 Months Ended

Mar. 31, 2022

Commitments and Contingencies Disclosure [Abstract]

COMMITMENTS AND CONTINGENCIES

(5) COMMITMENTS AND CONTINGENCIES

In August 2021, the Company entered into a lease agreement (the “Waltham Lease”) for approximately 5,000 square feet of office space in Waltham, Massachusetts for the Company’s corporate headquarters. The Waltham Lease has a term of thirty-nine months (“Lease Term”), unless extended or earlier terminated. The Company has the option to extend the Waltham Lease for one additional period of three years. The Lease Term has an initial abatement period, and the initial base rent payable will be approximately $18,000 per month following the abatement period. The initial base rent payable will increase by approximately 2% per year over the Lease Term. The Waltham Lease commencement date was September 1, 2021.

As of March 31, 2022, the future minimum annual lease payments under the operating lease was as follows (in thousands):


2022	$	144
2023		221
2024		206
Total operating lease payments		571
Less: Amount representing interest		(43	)
Present value of net minimum lease payments	$	528
Operating lease liabilities:
Current		193
Non-current		335
Total lease liability	$	528

Weighted-average remaining lease term (in years)		2.8
Weighted-average incremental borrowing rate		6	%

Supplemental cash flow information related to cash paid for amounts included in the measurement of operating lease liabilities was as follows (in thousands):

SCHEDULE OF SUPPLEMENTAL CASH FLOW

	2022		2021
	Three months ended March 31,
	2022		2021
Cash paid included in operating cash flows	$	54	$	-

Rent expense was as follows (in thousands):

SCHEDULE OF RENT EXPENSES

	2022		2021
	Three months ended March 31,
	2022		2021
Operating lease	$	51	$	-
Short-term lease		34
Total rent expense	$	85	$	-

STOCKHOLDERS’ EQUITY

3 Months Ended

Mar. 31, 2022

Equity [Abstract]

STOCKHOLDERS’ EQUITY

(6) STOCKHOLDERS’ EQUITY

On July 2, 2021, the Company’s certificate of amendment to its certificate of incorporation became effective, which provided 150,000,000 authorized shares of common stock with a par value of $0.0001 per share and 10,000,000 authorized shares of undesignated preferred stock with a par value of $0.0001 per share.

In August 2018, the Company issued 241,467 shares of common stock to RA Capital Healthcare Fund, L.P. at a price of $0.0012 per share. On July 2, 2021, in conjunction with the Company’s initial public offering, or IPO, the Company issued 9,984,463 shares of its common stock and all outstanding shares of the Company’s redeemable convertible preferred stock were converted into 14,182,854 shares of the Company’s common stock.

The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders.

As of March 31, 2022, the Company had reserved the following shares of common stock, on an as-converted basis, for future issuance:

	March 31, 2022
Common stock options granted and outstanding		3,703,931
Reserved for future option grants		1,811,438
Reserved for future ESPP issuances		230,000
Total		5,745,369

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.

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Share-Based Payment Arrangement [Abstract]

SHARE-BASED COMPENSATION

3 Months Ended

Mar. 31, 2022

SHARE-BASED COMPENSATION

(7) SHARE-BASED COMPENSATION

The Company’s 2021 Stock Option and Incentive Plan (the “2021 Plan”) was adopted by the Company’s board of directors and approved by the Company’s stockholders in June 2021 and became effective as of June 29, 2021. Upon the effectiveness of the 2021 Plan, the Company’s 2018 Equity Incentive Plan (the “2018 Plan”) was terminated and no further grants may be made thereunder. The Company’s 2021 Plan allows for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, stock bonuses, restricted stock, stock units and other forms of awards including cash awards to its officers, directors, employees, consultants and advisors.

As of March 31, 2022, a total of 3,576,415 shares of the Company’s common stock is authorized for issuance with respect to awards granted under the 2021 Plan. The share limit will automatically increase on the first trading day in January of each year (commencing with 2022) by an amount equal to the lesser of (1) 4% of the total number of outstanding shares of the Company’s common stock on the last trading day in December in the prior year, or (2) such lesser number as determined by the Company’s board of directors. Effective January 1, 2022, the number of shares available under the 2021 Plan increased by 976,415 shares, as determined by the Company’s board of directors.

Any shares subject to awards granted under the 2021 Plan or the 2018 Plan that are not paid, delivered or exercised before they expire or are canceled or terminated, or otherwise fail to vest, as well as shares used to pay the purchase or exercise price of such awards or related tax withholding obligations, will become available for new award grants under the 2021 Plan.

As of March 31, 2022, 1,764,977 awards had been granted under the 2021 Plan, and 1,811,438 shares authorized under the 2021 Plan were available for award purposes.

The options that are granted under the 2021 Plan and the 2018 Plan are exercisable at various dates as determined upon grant and terminate within 10 years of the date of grant. The vesting period generally occurs over three to four years.

The following table summarizes the option activity under the 2021 Plan and 2018 Plan for the three months ended March 31, 2022:

	Options		Weighted-Average Exercise Price		Weighted- Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value (in thousands)
Vested and expected to vest at December 31, 2021		3,454,374	$	6.85		9.42	$	19,378
Granted		249,557	$	12.56		9.94
Exercised		-		-
Cancelled/Forfeited		-		-
Outstanding at March 31, 2022		3,703,931	$	7.23		9.21	$	41,111
Vested and exercisable at March 31, 2022		478,573	$	4.98		8.97	$	6,392
Vested and expected to vest at March 31, 2022		3,703,931	$	7.23		9.21	$	41,111

The weighted-average grant date fair value of stock option grants was $4.54 per share for the three months ended March 31, 2022. All exercisable options are vested and all outstanding options are vested or expected to vest.

(b)

Employee Stock Purchase Plan

The Company’s Employee Stock Purchase Plan (the “ESPP”) was adopted by the Company’s board of directors and stockholders in June 2021 and became effective upon the consummation of the IPO. A total of 230,000 shares of the Company’s common stock is initially available for issuance under the ESPP. The ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation, subject to any plan limitations. The ESPP provides for six-month offering periods, and at the end of each offering period, employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the last trading day of the offering period. As of March 31, 2022, no shares had been issued under the ESPP, and the full number of shares authorized under the ESPP Plan was available for issuance purposes upon the effectiveness of the ESPP.

(c)

Share-Based Compensation Expense

The Company estimated the fair value of stock options using the Black-Scholes valuation model. The Company accounts for any forfeitures of options when they occur. Previously recognized compensation expense for an award is reversed in the period that the award is forfeited. The fair value of stock options was estimated using the following assumptions:

	Three Months Ended March 31,
	2022		2021
Expected term (in years)	5.3 - 6.1		-
Expected volatility	73.64% - 75.68	%	-
Risk-free interest rate	1.37% - 2.55	%	-
Expected dividend	-		-

Stock-based compensation expense recognized for stock option grants has been reported in the statements of operations and comprehensive loss as follows (in thousands):

	2022		2021
	Three Months Ended March 31,
	2022		2021
Research and development	$	256	$	12
General and administrative		768		11
Total	$	1,024	$	23

As of March 31, 2022, there was approximately $13.7 million of total unrecognized stock-based compensation expense related to nonvested stock-based compensation arrangements granted under the 2021 Plan and 2018 Plan, which is expected to be recognized over a weighted-average period of approximately 3.2 years.

RELATED PARTY TRANSACTIONS

3 Months Ended

Mar. 31, 2022

RELATED PARTY TRANSACTIONS

(8) RELATED PARTY TRANSACTIONS

Services Agreement

In August 2018, the Company entered into a services agreement (“Services Agreement”) with Carnot, LLC (“Carnot”), an entity owned and controlled by RA Capital Management, LLC under which Carnot provides research and other services to the Company. RA Capital Management, LLC is a related party due to its equity ownership of the Company. The Company pays Carnot for services performed and costs incurred. The Services Agreement is for a term of two years. The Company may terminate the Services Agreement by giving 30 days’ prior notice and either party can terminate the services agreement for a material breach, if not cured within 30 days following notice by the nonbreaching party.

In July 2019, the Services Agreement with Carnot was amended whereby research and other services are now performed by Carnot Pharma, LLC (“Carnot Pharma”), an entity owned and controlled by RA Capital Management, LLC, and the term was updated to the later of (i) two years from July 15, 2019 and (ii) completion of services under the agreement. As of March 31, 2022, Carnot is no longer providing services to the Company.

Expenses incurred by the Company under the Services Agreement with Carnot Pharma totaled $8,000 and $20,000 for the three months ended March 31, 2022 and 2021, and are presented in the statement of operations and comprehensive loss as research and development and general and administrative expenses. As of March 31, 2022 and December 31, 2021, $4,000 and $2,000, respectively, was due to Carnot Pharma by the Company for services rendered under the Services Agreement.

SUBSEQUENT EVENTS

3 Months Ended

Mar. 31, 2022

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

(9) SUBSEQUENT EVENTS

Lease agreement

In April 2022, the Company entered into a lease agreement in Foster City, California (the “Foster City Lease”). The term of the Foster City Lease is thirty-nine months from the lease commencement date and the Company has the option to extend the lease for one additional period of one year. Base rent under the Foster City Lease is approximately $22,600 per month and is subject to annual increases of 3% on each annual anniversary during the term. The expected lease commencement date under the Foster City Lease is August 1, 2022.

BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2022

Basis of Presentation

Basis of Presentation

(a)

Basis of Presentation

Reverse Stock Split

	*(b)*	*Reverse Stock Split*

Use of Estimates

Use of Estimates

(c)

Use of Estimates

Net Loss Per Share

Net Loss Per Share

(d)

Net Loss Per Share

The following table summarizes the Company’s net loss per share (in thousands, except share and per share amounts):

SCHEDULE OF NET LOSS PER SHARE

	2022			2021
	Three Months Ended March 31,
	2022			2021
Numerator:
Net loss	$	(10,910	)	$	(2,781	)
Accretion of Series A redeemable convertible preferred stock to redemption value		-			(13	)
Net loss available to common stockholders	$	(10,910	)	$	(2,794	)

Denominator:
Weighted-average common stock outstanding, basic and diluted		24,410,393			243,076
Net loss per share, basic and diluted	$	(0.45	)	$	(11.49	)

	As of March 31,
	2022		2021
Options to purchase common stock		3,703,931		229,105
Series Seed redeemable convertible preferred stock		-		1,287,825
Series A redeemable convertible preferred stock		-		3,449,369
		3,703,931		4,966,299

BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Tables)

3 Months Ended

Mar. 31, 2022

SCHEDULE OF NET LOSS PER SHARE

The following table summarizes the Company’s net loss per share (in thousands, except share and per share amounts):

SCHEDULE OF NET LOSS PER SHARE

	2022			2021
	Three Months Ended March 31,
	2022			2021
Numerator:
Net loss	$	(10,910	)	$	(2,781	)
Accretion of Series A redeemable convertible preferred stock to redemption value		-			(13	)
Net loss available to common stockholders	$	(10,910	)	$	(2,794	)

Denominator:
Weighted-average common stock outstanding, basic and diluted		24,410,393			243,076
Net loss per share, basic and diluted	$	(0.45	)	$	(11.49	)

SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES NOT INCLUDED IN THE CALCULATION OF DILUTED NET LOSS PER SHARE

	As of March 31,
	2022		2021
Options to purchase common stock		3,703,931		229,105
Series Seed redeemable convertible preferred stock		-		1,287,825
Series A redeemable convertible preferred stock		-		3,449,369
		3,703,931		4,966,299

FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables)

3 Months Ended

Mar. 31, 2022

Fair Value Disclosures [Abstract]

SCHEDULE OF FAIR VALUE INSTRUMENTS

The following tables summarize the Company’s financial assets measured at fair value on a recurring basis and their respective input levels based on the fair value hierarchy (in thousands):

SCHEDULE OF FAIR VALUE INSTRUMENTS

	March 31, 2022		Quoted Prices in Active Markets for Indentical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (level 3)
			Fair Value Measurements Using
	March 31, 2022		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (level 3)
Assets:
Cash equivalents
Money market funds		12,736		12,736		-		-
Commercial paper		11,090		-		11,090		-
Total cash equivalents		23,826		12,736		11,090		-

Short-term investments
U.S. Treasury bills		32,319		32,319		-		-
Corporate debt securities		7,631		-		7,631		-
Commercial paper		92,985		-		92,985		-
Total short-term investments		132,935		32,319		100,616		-

Total	$	156,761	$	45,055	$	111,706	$	-

	December 31, 2021		Quoted Prices in Active Markets for Indentical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (level 3)
			Fair Value Measurements Using
	December 31, 2021		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (level 3)
Assets:
Cash equivalents
Money market funds	$	39,653	$	39,653	$	-	$	-
Commercial paper		14,448		-		14,448		-
Total cash equivalents		54,101		39,653		14,448		-

Short-term investments
U.S. Treasury bills		25,135		25,135		-		-
Corporate debt securities		10,715		-		10,715		-
Commercial paper		77,328		-		77,328		-
Total short-term investments		113,178		25,135		88,043		-

Total	$	167,279	$	64,788	$	102,491	$	-

SUMMARY OF SHORT TERM INVESTMENT

The following tables summarize the Company’s short-term investments (in thousands):

SUMMARY OF SHORT TERM INVESTMENT

		As of March 31, 2022
	Maturity	Amortized cost		Gross unrealized gains		Gross unrealized losses			Estimated fair value
Corporate debt securities	1 year or less	$	7,650	$	-	$	(18	)	$	7,632
Commercial paper	1 year or less		93,256		-		(272	)	$	92,984
U.S. Treasury bills	2 years or less		32,673		-		(354	)	$	32,319
		$	133,579	$	-	$	(644	)	$	132,935

		As of December 31, 2021
	Maturity	Amortized cost		Gross unrealized gains		Gross unrealized losses			Estimated fair value
Corporate debt securities	1 year or less	$	10,726	$	-	$	(11	)	$	10,715
Commercial paper	1 year or less		77,328		9		(9	)		77,328
U.S. Treasury bills	2 years or less		25,183		-		(48	)		25,135
		$	113,237	$	9	$	(68	)	$	113,178

BALANCE SHEET COMPONENTS (Tables)

3 Months Ended

Mar. 31, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS

Prepaid expenses and other current assets consisted of the following (in thousands):

	March 31,		December 31,
	2022		2021
Prepaid research and development	$	3,628	$	5,233
Prepaid expenses		896		1,485
Other current assets		289		240
Total prepaid expenses and other current assets	$	4,813	$	6,958

SCHEDULE OF ACCRUED AND OTHER CURRENT LIABILITIES

Accrued and other current liabilities consisted of the following (in thousands):

	March 31,		December 31,
	2022		2021
Accrued research and development	$	1,019	$	217
Accrued payroll and other employee benefits		387		790
Other		241		143
Total accrued and other current liabilities	$	1,647	$	1,150

COMMITMENTS AND CONTINGENCIES (Tables)

3 Months Ended

Mar. 31, 2022

Commitments and Contingencies Disclosure [Abstract]

SCHEDULE OF FUTURE MINIMUM ANNUAL LEASE PAYMENTS FOR OPERATING LEASES

As of March 31, 2022, the future minimum annual lease payments under the operating lease was as follows (in thousands):


2022	$	144
2023		221
2024		206
Total operating lease payments		571
Less: Amount representing interest		(43	)
Present value of net minimum lease payments	$	528
Operating lease liabilities:
Current		193
Non-current		335
Total lease liability	$	528

Weighted-average remaining lease term (in years)		2.8
Weighted-average incremental borrowing rate		6	%

SCHEDULE OF SUPPLEMENTAL CASH FLOW

Supplemental cash flow information related to cash paid for amounts included in the measurement of operating lease liabilities was as follows (in thousands):

SCHEDULE OF SUPPLEMENTAL CASH FLOW

	2022		2021
	Three months ended March 31,
	2022		2021
Cash paid included in operating cash flows	$	54	$	-

SCHEDULE OF RENT EXPENSES

Rent expense was as follows (in thousands):

SCHEDULE OF RENT EXPENSES

	2022		2021
	Three months ended March 31,
	2022		2021
Operating lease	$	51	$	-
Short-term lease		34
Total rent expense	$	85	$	-

STOCKHOLDERS’ EQUITY (Tables)

3 Months Ended

Mar. 31, 2022

Equity [Abstract]

SCHEDULE OF COMMON STOCK SHARES RESERVED FOR ON AND AS-CONVERTED BASIS, FOR FUTURE ISSUANCE

As of March 31, 2022, the Company had reserved the following shares of common stock, on an as-converted basis, for future issuance:

	March 31, 2022
Common stock options granted and outstanding		3,703,931
Reserved for future option grants		1,811,438
Reserved for future ESPP issuances		230,000
Total		5,745,369

SHARE-BASED COMPENSATION (Tables)

3 Months Ended

Mar. 31, 2022

Share-Based Payment Arrangement [Abstract]

SUMMARY OF OPTION ACTIVITY UNDER 2021 PLAN AND 2018 PLAN

The following table summarizes the option activity under the 2021 Plan and 2018 Plan for the three months ended March 31, 2022:

	Options		Weighted-Average Exercise Price		Weighted- Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value (in thousands)
Vested and expected to vest at December 31, 2021		3,454,374	$	6.85		9.42	$	19,378
Granted		249,557	$	12.56		9.94
Exercised		-		-
Cancelled/Forfeited		-		-
Outstanding at March 31, 2022		3,703,931	$	7.23		9.21	$	41,111
Vested and exercisable at March 31, 2022		478,573	$	4.98		8.97	$	6,392
Vested and expected to vest at March 31, 2022		3,703,931	$	7.23		9.21	$	41,111

SUMMARY OF FAIR VALUE OF STOCK OPTIONS ASSUMPTIONS

	Three Months Ended March 31,
	2022		2021
Expected term (in years)	5.3 - 6.1		-
Expected volatility	73.64% - 75.68	%	-
Risk-free interest rate	1.37% - 2.55	%	-
Expected dividend	-		-

SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION GRANTS

Stock-based compensation expense recognized for stock option grants has been reported in the statements of operations and comprehensive loss as follows (in thousands):

	2022		2021
	Three Months Ended March 31,
	2022		2021
Research and development	$	256	$	12
General and administrative		768		11
Total	$	1,024	$	23

ORGANIZATION AND NATURE OF OPERATIONS (Details Narrative) $ in Millions	Mar. 31, 2022 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Cash and cash equivalents and short term investment	$ 161.1

SCHEDULE OF NET LOSS PER SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Net loss	$ (10,910)	$ (2,781)
Accretion of Series A redeemable convertible preferred stock to redemption value		13
Net loss available to common stockholders	$ (10,910)	$ (2,794)
Weighted-average common stock outstanding, basic and diluted	24,410,393	243,076
Net loss per share, basic and diluted	$ (0.45)	$ (11.49)
Series A Redeemable Convertible Preferred Stock [Member]
Accretion of Series A redeemable convertible preferred stock to redemption value		$ (13)

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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Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

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SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES NOT INCLUDED IN THE CALCULATION OF DILUTED NET LOSS PER SHARE (Details) - shares	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	3,703,931	4,966,299
Share-Based Payment Arrangement, Option [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	3,703,931	229,105
Series Seed Redeemable Convertible Preferred Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount		1,287,825
Series A Redeemable Convertible Preferred Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount		3,449,369

BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)

Jun. 22, 2021

Stockholders' equity, reverse stock split

1-for-3.1060103 reverse stock split (the “Reverse Stock Split”) of its issued and outstanding common stock. Accordingly, the conversion ratio for the Company’s outstanding convertible preferred stock was proportionately adjusted such that the common stock issuable upon conversion of such preferred stock was decreased in proportion to the Reverse Stock Split. The par value of the common stock was not adjusted as a result of the Reverse Stock Split. All references to common stock, options to purchase common stock, early exercised options, share data, per share data, convertible preferred stock (to the extent presented on an as-converted to common stock basis) and related information contained in these financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented.

SCHEDULE OF FAIR VALUE INSTRUMENTS (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Cash equivalents
Money market funds	$ 12,736	$ 39,653
Commercial paper	11,090	14,448
Total cash equivalents	23,826	54,101
Short-term investments
U.S. Treasury bills	32,319	25,135
Corporate debt securities	7,631	10,715
Commercial paper	92,985	77,328
Total short-term investments	132,935	113,178
Total	156,761	167,279
Fair Value, Inputs, Level 1 [Member]
Cash equivalents
Money market funds	12,736	39,653
Commercial paper
Total cash equivalents	12,736	39,653
Short-term investments
U.S. Treasury bills	32,319	25,135
Corporate debt securities
Commercial paper
Total short-term investments	32,319	25,135
Total	45,055	64,788
Fair Value, Inputs, Level 2 [Member]
Cash equivalents
Money market funds
Commercial paper	11,090	14,448
Total cash equivalents	11,090	14,448
Short-term investments
U.S. Treasury bills
Corporate debt securities	7,631	10,715
Commercial paper	92,985	77,328
Total short-term investments	100,616	88,043
Total	111,706	102,491
Fair Value, Inputs, Level 3 [Member]
Cash equivalents
Money market funds
Commercial paper
Total cash equivalents
Short-term investments
U.S. Treasury bills
Corporate debt securities
Commercial paper
Total short-term investments
Total

SUMMARY OF SHORT TERM INVESTMENT (Details) - USD ($) $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]
Amortized cost	$ 133,579	$ 113,237
Gross unrealized gains		9
Gross unrealized losses	(644)	(68)
Estimated fair value	$ 132,935	$ 113,178
Corporate Debt Securities [Member]
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]
Maturity	1 year or less	1 year or less
Amortized cost	$ 7,650	$ 10,726
Gross unrealized gains
Gross unrealized losses	(18)	(11)
Estimated fair value	$ 7,632	$ 10,715
Commercial Paper [Member]
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]
Maturity	1 year or less	1 year or less
Amortized cost	$ 93,256	$ 77,328
Gross unrealized gains		9
Gross unrealized losses	(272)	(9)
Estimated fair value	$ 92,984	$ 77,328
US Treasury Securities [Member]
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]
Maturity	2 years or less	2 years or less
Amortized cost	$ 32,673	$ 25,183
Gross unrealized gains
Gross unrealized losses	(354)	(48)
Estimated fair value	$ 32,319	$ 25,135

FAIR VALUE OF FINANCIAL INSTRUMENTS (Details Narrative) - USD ($) $ in Millions	Mar. 31, 2022	Dec. 31, 2021
Short-Term Investments [Member]
Fair Value, Investments, Entities that Calculate Net Asset Value Per Share [Line Items]
Accrued interest receivable	$ 0.1	$ 0.1

SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Prepaid research and development	$ 3,628	$ 5,233
Prepaid expenses	896	1,485
Other current assets	289	240
Total prepaid expenses and other current assets	$ 4,813	$ 6,958

SCHEDULE OF ACCRUED AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Accrued research and development	$ 1,019	$ 217
Accrued payroll and other employee benefits	387	790
Other	241	143
Total accrued and other current liabilities	$ 1,647	$ 1,150

SCHEDULE OF FUTURE MINIMUM ANNUAL LEASE PAYMENTS FOR OPERATING LEASES (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
2022	$ 144
2023	221
2024	206
Total operating lease payments	571
Less: Amount representing interest	(43)
Total lease liability	528
Operating lease liabilities:
Current	193	$ 192
Non-current	$ 335	$ 382
Weighted-average remaining lease term (in years)	2 years 9 months 18 days
Weighted-average incremental borrowing rate	6.00%

SCHEDULE OF SUPPLEMENTAL CASH FLOW (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Cash paid included in operating cash flows	$ 54

SCHEDULE OF RENT EXPENSES (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Operating lease	$ 51
Short-term lease	34
Total rent expense	$ 85

COMMITMENTS AND CONTINGENCIES (Details Narrative) - Waltham Lease [Member] $ in Thousands	1 Months Ended
	Aug. 31, 2021 USD ($) ft²
Lessee, Lease, Description [Line Items]
Area of land \| ft²	5,000
Operating lease term	39 months
Lease, option to extend	The Company has the option to extend the Waltham Lease for one additional period of three years.
Payment for rent \| $	$ 18,000
Lease rent percentage	2.00%

SCHEDULE OF COMMON STOCK SHARES RESERVED FOR ON AND AS-CONVERTED BASIS, FOR FUTURE ISSUANCE (Details) - shares	Mar. 31, 2022	Dec. 31, 2021
Equity [Abstract]
Common stock options granted and outstanding	3,703,931	3,454,374
Reserved for future option grants	1,811,438
Reserved for future ESPP issuances	230,000
Total	5,745,369

STOCKHOLDERS’ EQUITY (Details Narrative) - $ / shares		1 Months Ended
STOCKHOLDERS’ EQUITY (Details Narrative) - $ / shares	Jul. 02, 2021	Aug. 31, 2018	Mar. 31, 2022	Dec. 31, 2021
Subsidiary, Sale of Stock [Line Items]
Common stock, shares authorized	150,000,000		150,000,000	150,000,000
Common stock, par value	$ 0.0001		$ 0.0001	$ 0.0001
Preferred stock, shares authorized	10,000,000		10,000,000	10,000,000
Preferred stock, par value	$ 0.0001		$ 0.0001	$ 0.0001
IPO [Member]
Subsidiary, Sale of Stock [Line Items]
Number of shares issued	9,984,463
RA Capital Healthcare Fund, L.P [Member]
Subsidiary, Sale of Stock [Line Items]
Number of shares issued		241,467
Share price		$ 0.0012
Conversion of stock shares issued	14,182,854

SUMMARY OF OPTION ACTIVITY UNDER 2021 PLAN AND 2018 PLAN (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
Share-Based Payment Arrangement [Abstract]
Options Outstanding, beginning balance	3,454,374
Weighted-Average Exercise Price Outstanding, beginning balance	$ 6.85
Weighted- Average Remaining Contractual Term, Outstanding	9 years 2 months 15 days	9 years 5 months 1 day
Aggregate Intrinsic Value Outstanding, beginning balance	$ 19,378
Options Granted	249,557
Weighted-Average Exercise Price, Granted	$ 12.56
Weighted- Average Remaining Contractual Term, Granted	9 years 11 months 8 days
Options Exercised
Weighted-Average Exercise Price, Exercised
Options, Cancelled/Forfeited
Weighted-Average Exercise Price, Cancelled/Forfeited
Options Outstanding, ending balance	3,703,931	3,454,374
Weighted-Average Exercise Price Outstanding, ending balance	$ 7.23	$ 6.85
Aggregate Intrinsic Value Outstanding, ending balance	$ 41,111	$ 19,378
Options, Vested and exercisable	478,573
Weighted-Average Exercise Price, Vested and exercisable	$ 4.98
Weighted- Average Remaining Contractual Term, Vested and exercisable	8 years 11 months 19 days
Aggregate Intrinsic Value, Vested and exercisable	$ 6,392
Options, Vested and expected to vest	3,703,931,000
Weighted-Average Exercise Price, Vested and expected to vest	$ 7.23
Weighted- Average Remaining Contractual Term, Vested and expected to vest	9 years 2 months 15 days
Aggregate Intrinsic Value, Vested and expected to vest	$ 41,111

SUMMARY OF FAIR VALUE OF STOCK OPTIONS ASSUMPTIONS (Details)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)
Expected volatility, minimum	73.64%
Expected volatility, maximum	75.68%
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate
Risk-free interest rate, minimum	1.37%
Risk-free interest rate, maximum	2.55%
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Risk Free Interest Rate
Expected dividend
Minimum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)	5 years 3 months 18 days
Maximum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)	6 years 1 month 6 days

SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION GRANTS (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	$ 1,024	$ 23
Research and Development Expense [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	256	12
General and Administrative Expense [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	$ 768	$ 11

SHARE-BASED COMPENSATION (Details Narrative) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended	3 Months Ended	12 Months Ended
	Jun. 30, 2021	Mar. 31, 2022	Dec. 31, 2021	Feb. 01, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock available for issuance		1,811,438
Stock option grants per share		$ 4.54
Unrecognized stock based compensation		$ 13.7
Unrecognized stock-based compensation weighted-average period		3 years 2 months 12 days
2021 Stock Option and Incentive Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Percentage on total number of shares outstanding		4.00%
Employee Stock Purchase Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares authorized	230,000			976,415
Percentage of common stock purchase price	15.00%
Discount percentage on marker price	85.00%
Shares issued		0
2021 Plan and 2018 Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expiration period		10 years
Vesting period description			three to four years
Share-Based Payment Arrangement, Option [Member] \| 2021 Stock Option and Incentive Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock available for issuance		3,576,415
Number of shares authorized		1,811,438
Common stock available for issuance, awards granted		1,764,977

RELATED PARTY TRANSACTIONS (Details Narrative) - Service agreement with carnot LLC - USD ($) $ in Thousands	1 Months Ended		3 Months Ended
	Jul. 31, 2019	Aug. 31, 2018	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Related Party Transaction [Line Items]
Term of service agreement	2 years	2 years
Related party expenses			$ 8,000	$ 20,000
Due to related party			$ 4,000		$ 2,000

Carrying amount as of the balance sheet date of obligations due all related parties.

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