Jade Biosciences, Inc. 10-K

Item 9A. Controls and Procedures. Management’s Evaluation of our Disclosure Controls and Procedures We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our principal executive and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their control objectives. Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2021, the end of the period covered by this Annual Report on Form 10-K. Based upon such evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of such date. Management’s Report on Internal Control over Financial Reporting This Annual Report on Form 10-K does not include a report of management’s assessment regarding internal control over financial reporting due to a transition period established by rules of the SEC for newly public companies. Attestation Report of the Registered Public Accounting Firm This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm due to an exemption established by the JOBS Act for “emerging growth companies.” Changes in Internal Control over Financial Reporting There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this Annual Report on Form 10-K that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. Item 9B. Other Information. 2022 Annual Stockholder Meeting We currently plan to hold our 2022 Annual Meeting of Stockholders, or the Annual Meeting, on June 21, 2022. Pursuant to the provisions of our Amended and Restated Bylaws, or Bylaws, for any stockholder to propose business (other than pursuant to and in compliance with Exchange Act Rule 14a-8) or make a nomination before the Annual Meeting, the stockholder must have given timely notice in writing to the secretary and any such nomination or proposed business must constitute a proper matter for stockholder action. Under our Bylaws, to be timely, a stockholder’s notice must be received by the secretary at our principal executive offices no earlier than 8:00 a.m., local time, on the 120th day and no later than 5:00 p.m., local time, on the 90th day prior to the day of the first anniversary of the preceding year’s annual meeting of stockholders; provided, however, that if no annual meeting of stockholders was held in the preceding year, or if the date of the applicable annual meeting has been changed by more than 25 days from the first anniversary of the preceding year’s annual meeting, then to be timely such notice must be received by the secretary at our principal executive offices no earlier than 8:00 a.m., local time, on the 120th day prior to the day of the annual meeting and no later than 5:00 p.m., local time, on the 10th day following the day on which we made the first public announcement of the date of the annual meeting. Because we did not hold an annual meeting last year, we have determined that the date by which stockholders must deliver such notice for the purposes of the Annual Meeting is April 9, 2022, which is 10 days after the filing of this Annual Report on Form 10-K. Pursuant to Rule 14a-8, for a stockholder to submit a proposal for inclusion in our proxy materials for the Annual Meeting, the stockholder must comply with the requirements set forth in Rule 14a-8 including with respect to the subject matter of such proposal and must deliver the proposal and all required documentation to us a reasonable time before we begin to print and send our proxy materials for the meeting. For the purposes of the Annual Meeting, we have determined that April 9, 2022 is a reasonable time before we plan to begin printing and mailing our proxy materials. The public announcement of an adjournment or postponement of the Annual Meeting date will not commence a new time period (or extend any time period) for giving such notice under our Bylaws or submitting a proposal pursuant to Rule 14a-8. Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. Not applicable. 99 PART III Item 10. Directors, Executive Officers and Corporate Governance. The information required by this Item 10 will be included in our Definitive Proxy Statement to be filed with the Securities and Exchange Commission, or SEC, with respect to our 2022 Annual Meeting of Stockholders and is incorporated herein by reference. Item 11. Executive Compensation. The information required by this Item 11 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2022 Annual Meeting of Stockholders and is incorporated herein by reference. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. The information required by this Item 12 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2022 Annual Meeting of Stockholders and is incorporated herein by reference. Item 13. Certain Relationships and Related Transactions, and Director Independence. The information required by this Item 13 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2022 Annual Meeting of Stockholders and is incorporated herein by reference. Item 14. Principal Accounting Fees and Services. Our independent public accounting firm is KPMG LLP , San Diego, California (PCAOB Auditor ID: 185 ). The information required by this Item 14 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2022 Annual Meeting of Stockholders and is incorporated herein by reference. 100 PART IV Item 15. Exhibits, Financial Statement Schedules 1. All financial statements. The consolidated financial statements of Aerovate Therapeutics, Inc., together with the report thereon of KPMG LLP, an independent registered public accounting firm, are included in this annual report on Form 10-K beginning on page F-1. 2. Financial statement schedules. All schedules have been omitted because the information required to be set forth therein is not applicable or is shown in the consolidated financial statements or notes thereto. 3. Exhibits A list of exhibits is set forth on the Exhibit Index immediately preceding the signature page of this annual report on Form 10-K and is incorporated herein by reference. Item 16. Form 10-K Summary The Company has elected not to include summary information. 101 AEROVATE THERAPEUTICS, INC. INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (Auditor Firm ID: 185) F-2 Consolidated Balance Sheets F-3 Consolidated Statements of Operations and Comprehensive Loss F-4 Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) F-5 Consolidated Statements of Cash Flows F-6 Notes to Consolidated Financial Statements F-7 F- 1 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Stockholders and Board of Directors Aerovate Therapeutics, Inc.: Opinion on the Consolidated Financial Statements We have audited the accompanying consolidated balance sheets of Aerovate Therapeutics, Inc. and subsidiary (the Company) as of December 31, 2021 and 2020, the related consolidated statements of operations and comprehensive loss, redeemable convertible preferred stock and stockholders’ equity (deficit), and cash flows for the years then ended, and the related notes (collectively, the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for the years then ended, in conformity with U.S. generally accepted accounting principles. Basis for Opinion These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion. /s/ KPMG LLP We have served as the Company’s auditor since 2019. San Diego, California March 30, 2022 F- 2 Aerovate Therapeutics, Inc. Consolidated Balance Sheets (in thousands, except share and per share amounts) 2021 2020 December 31, 2021 2020 Assets Current assets: Cash and cash equivalents $ 54,197 $ 4,573 Short-term investments 113,178 - Prepaid expenses and other current assets (Note 4) 6,958 103 Total current assets 174,333 4,676 Property and equipment, net 186 39 Operating lease right-of-use asset 542 - Other long-term assets 302 - Total assets $ 175,363 $ 4,715 Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) Current liabilities: Accounts payable (including related party amounts of $ 2 and $ 6 , respectively) $ 1,208 $ 618 Accrued and other current liabilities (Note 4) 1,150 1,156 Operating lease liability 192 - Total current liabilities 2,550 1,774 Operating lease liabilities, net of current portion 382 - Other liabilities 13 - Total liabilities 2,945 1,774 Commitments and contingencies (Note 6) - - Series A redeemable convertible preferred stock, $ 0.0001 par value; 0 and 40,052,154 shares authorized at December 31, 2021 and December 31, 2020, respectively; 0 and 6,489,534 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively - 12,285 Series Seed redeemable convertible preferred stock, $ 0.0001 par value; 0 and 4,000,000 shares authorized, issued and outstanding at December 31, 2021 and December 31, 2020, respectively - 4,000 Temporary Equity Value Stockholders’ equity (deficit): Common stock, $ 0.0001 par value; 150,000,000 and 50,000,000 shares authorized at December 31, 2021 and December 31, 2020, respectively; 24,410,393 and 243,076 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively 2 - Additional paid-in capital 208,867 63 Accumulated other comprehensive loss ( 59 ) - Accumulated deficit ( 36,392 ) ( 13,407 ) Total stockholders’ equity (deficit) 172,418 ( 13,344 ) Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) $ 175,363 $ 4,715 See accompanying notes to consolidated financial statements. F- 3 Aerovate Therapeutics, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) 2021 2020 Years Ended December 31, 2021 2020 Operating expenses: Research and development (includes related party amounts of $ 76 and $ 72 , respectively) $ 14,987 $ 7,940 General and administrative (includes related party amounts of $ 14 and $ 31 , respectively) 8,035 949 Total operating expenses 23,022 8,889 Loss from operations ( 23,022 ) ( 8,889 ) Other income (expense): Interest income (expense) 65 ( 75 ) Change in fair value of convertible promissory notes - ( 644 ) Other expense ( 3 ) ( 3 ) Total other income (expense) 62 ( 722 ) Net loss before income taxes ( 22,960 ) ( 9,611 ) Provision for income taxes 3 - Net loss $ ( 22,963 ) $ ( 9,611 ) Comprehensive loss: Net loss $ ( 22,963 ) $ ( 9,611 ) Other comprehensive loss: Unrealized loss on securities ( 59 ) - Comprehensive loss $ ( 23,022 ) $ ( 9,611 ) Net loss per share, basic and diluted $ ( 1.87 ) $ ( 40.31 ) Weighted-average shares of common stock outstanding, basic and diluted 12,293,629 242,232 See accompanying notes to consolidated financial statements. F- 4 Aerovate Therapeutics, Inc. Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) (in thousands, except share amounts) Shares Amount Shares Amount Shares Amount Capital Loss Deficit (Deficit) Series A Redeemable Convertible Series Seed Redeemable Convertible Additional Accumulated Other Total Stockholders’ Preferred Stock Preferred Stock Common Stock Paid-In Comprehensive Accumulated Equity Shares Amount Shares Amount Shares Amount Capital Loss Deficit (Deficit) Balance at December 31, 2019 - $ - 4,000,000 $ 4,000 241,467 $ - $ - $ - $ ( 3,643 ) $ (3,643 ) Balance at December 31, 2019 241,467 $ - $ - $ - $ ( 3,643 ) $ ( 3,643 ) Issuance of Series A redeemable convertible preferred stock upon conversion of December 2019 convertible promissory notes to related party 1,700,343 3,219 - - - - - - - - Issuance of Series A redeemable convertible preferred stock upon conversion of July 2020 convertible promissory notes to related party 1,320,655 2,500 - - - - - - - - Issuance of Series A redeemable convertible preferred stock at $ 1.893 per share, net of issuance costs of $ 153 3,468,536 6,413 - - - - - - - - Accretion of Series A redeemable convertible preferred stock to redemption value - 153 - - - - - - ( 153 ) ( 153 ) Issuance of common stock upon exercise of stock options - - - - 1,609 - 5 - - 5 Stock based compensation - - - - - - 58 - - 58 Unrealized loss on investments Net loss - - - - - - - - ( 9,611 ) ( 9,611 ) Balance at December 31, 2020 6,489,534 $ 12,285 4,000,000 $ 4,000 243,076 $ - $ 63 $ - $ ( 13,407 ) $ (13,344 ) Beginning balance 243,076 $ - $ 63 $ - $ ( 13,407 ) $ ( 13,344 ) Issuance of Series A redeemable convertible preferred stock at $ 1.893 per share, net of issuance costs of $ 22 33,562,620 63,512 - - - - - - - - Issuance of Series A redeemable convertible preferred stock per share, net of issuance costs 33,562,620 63,512 - - - - - - - - Accretion of Series A redeemable convertible preferred stock to redemption value - 22 - - - - - - ( 22 ) ( 22 ) Conversion of redeemable convertible preferred stock to common stock upon initial public offering ( 40,052,154 ) ( 75,819 ) ( 4,000,000 ) ( 4,000 ) 14,182,854 1 79,817 - - 79,818 Issuance of common stock upon initial public offering, net of issuance costs - - - - 9,984,463 1 126,944 - - 126,945 Unrealized loss on investments - - - - - - - ( 59 ) ( 59 ) Stock based compensation - - - - - - 2,043 - - 2,043 Net loss - - - - - - - - ( 22,963 ) ( 22,963 ) Balance at December 31, 2021 - $ - - $ - 24,410,393 $ 2 $ 208,867 $ ( 59 ) $ ( 36,392 ) $ 172,418 Ending b alance 24,410,393 $ 2 $ 208,867 $ ( 59 ) $ ( 36,392 ) $ 172,418 See accompanying notes to consolidated financial statements. F- 5 AEROVATE THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS) 2021 2020 Years Ended December 31, 2021 2020 Cash flow from operating activities: Net loss $ ( 22,963 ) $ ( 9,611 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 2,043 58 Depreciation and amortization expense 15 1 Accretion of discounts and amortization of premiums on investments, net 16 - Non-cash interest expense - 75 Change in fair value of convertible promissory notes to related party - 644 Changes in operating assets and liabilities: Prepaid expenses and other current assets ( 6,855 ) ( 103 ) Other long-term assets ( 302 ) - Accounts payable 609 37 Accrued and other liabilities ( 6 ) 1,040 Operating lease asset and liability, net 32 - Other liabilities 12 - Net cash used in operating activities ( 27,399 ) ( 7,859 ) Cash flow from investing activities: Purchases of investments ( 113,253 ) - Purchases of property and equipment ( 181 ) - Net cash used in investing activities ( 113,434 ) - Cash flow from financing activities: Proceeds from sale of Series A redeemable convertible preferred stock, net of issuance costs 63,512 6,413 Proceeds from issuance of convertible promissory notes to related party - 2,500 Proceeds from exercise of stock options - 5 Proceeds from issuance of common stock, net of issuance costs 126,945 - Net cash provided by financing activities 190,457 8,918 Net increase in cash 49,624 1,059 Cash and cash equivalents at the beginning of the year 4,573 3,514 Cash and cash equivalents at the end of the period $ 54,197 $ 4,573 Supplemental disclosure of noncash investing and financing activities: Conversion of redeemable convertible preferred stock to common stock upon initial public offering $ 79,818 $ - Right-of-use asset obtained in exchange for operating lease liability $ 542 $ - Purchases of property and equipment in accounts payable $ 21 $ 40 Conversion of convertible promissory notes to related party to Series A redeemable convertible preferred stock $ - $ ( 3,219 ) Conversion of convertible promissory notes to related party to Series A redeemable convertible preferred stock $ - $ ( 2,500 ) See accompanying notes to consolidated financial statements. F- 6 Aerovate Therapeutics, Inc. Notes to CONSOLIDATED Financial Statements (1) ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (a) Organization and Nature of Operations Aerovate Therapeutics Inc. (“Aerovate” or the “Company”) was incorporated in the state of Delaware in July 2018, and is headquartered in Waltham, Massachusetts. The Company has a wholly owned subsidiary, Aerovate Securities Corporation. The Company is a clinical stage biopharmaceutical company that is focused on the development of drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease. The Company’s initial focus is on advancing AV-101, the Company’s dry powder inhaled formulation of imatinib for the treatment of pulmonary arterial hypertension (“PAH”). The Company initiated a Phase 2b/Phase 3 trial of AV-101 in PAH patients in December 2021. (b) Initial Public Offering On July 2, 2021, the Company completed its initial public offering (“IPO”). The Company’s Registration Statement on Form S-1 (File No. 333-256949) relating to the IPO was declared effective by the Securities and Exchange Commission (“SEC”) on June 29, 2021. The shares began trading on The Nasdaq Global Market on June 30, 2021. The Company issued 9,984,463 shares of its common stock, including 1,302,321 shares associated with the full exercise of the underwriters’ option to purchase additional shares, at an offering price of $ 14.00 per share. Immediately prior to the closing of the Company’s IPO on July 2, 2021, all outstanding shares of the Company’s redeemable convertible preferred stock were converted into 14,182,854 shares of the Company’s common stock. In aggregate, the shares issued in the IPO generated approximately $ 126.9 million in net proceeds after deducting underwriting discounts and commissions and other offering costs. (c) Liquidity and Management Plans Since inception, the Company has devoted substantially all of its resources to research and development activities, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations and has not realized revenues from its planned principal operations. The Company has incurred losses and negative cash flows from operations since inception. In addition, the Company expects to incur substantial operating losses for the next several years as it continues its research and development activities. As of December 31, 2021, the Company had cash and cash equivalents and short-term investments of $ 167.4 million. Management plans to continue to incur substantial costs in order to conduct research and development activities and additional capital will be needed to undertake these activities. The Company intends to raise such capital through debt or equity financings or other arrangements to fund operations. Management believes that the Company’s current cash and cash equivalents and short-term investments will provide sufficient funds to enable the Company to meet its obligations for at least twelve months from the filing date of this report. (2) BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (a) Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include the Company’s wholly owned subsidiary, Aerovate Securities Corporation. All intercompany transactions and balances have been eliminated in consolidation. F- 7 (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 consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented . (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. (d) Cash and Cash Equivalents Cash and cash equivalents include cash in readily available checking accounts, money market funds and commercial paper. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. (e) Short-term Investments Short-term investments consist of corporate debt securities, commercial paper and U.S. Treasury bills, classified as available-for-sale securities and have maturities of greater than three months. The Company has classified all of its available-for-sale investment securities as current assets on the consolidated balance sheets because these are considered highly liquid securities and are available for use in current operations. The Company carries these securities at fair value and reports unrealized gains and losses as a separate component of accumulated other comprehensive loss. The cost of debt securities is adjusted for amortization of purchase premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income in the consolidated statements of operations and comprehensive loss. Realized gains and losses on sales of securities are determined using the specific identification method and recorded in other income (expense), net in the consolidated statement of operations and comprehensive loss . (f) Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash, cash equivalents and short-term investments. The Company maintains cash, cash equivalents and short-term investments with various high credit quality banks and other financial institutions in the United States. Such deposits may be in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company has not experienced any losses on deposits since inception. (g) Comprehensive Loss Comprehensive loss consists of net loss and unrealized gains or losses on available-for-sale investments. The Company displays comprehensive loss and its components as part of the consolidated statements of operations and comprehensive loss. F- 8 (h) Fair Value Measurements The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets. Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. The carrying amounts of prepaid expenses and other current assets, accounts payable, accrued liabilities and other current liabilities are reasonable estimates of their fair value due to the short-term nature of these accounts. Convertible promissory notes were classified within the Level 3 designation and were recorded at fair value on a recurring basis prior to their conversion during the year ended December 31, 2020. (i) Prepaid Expenses and Other Current Assets Any expenses paid prior to the related services rendered are recorded as prepaid expenses. Such prepaid expenses are expensed in the period the expense is incurred. If the expense is for a service covering multiple periods, it is expensed from the date the services begin and over the period of the service rendered (or contract service period if services rendered dates are not defined). (j) Property and Equipment, Net Property and equipment, which consist of leasehold improvements, furniture and fixtures, research equipment, computers and construction-in-progress are stated at cost less accumulated depreciation or accumulated amortization. Depreciation and amortization is calculated using the straight-line method over the estimated useful lives of the assets, which ranges from three to five years. Leasehold improvements are amortized over the remaining life of the lease for leasehold improvements at the time the asset is placed into service. (k) Impairment of Long-lived Assets The carrying value of long-lived assets, including property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the asset may not be recoverable. An impairment loss is recognized when the total of estimated future undiscounted cash flows, expected to result from the use of the asset and its eventual disposition, are less than its carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. Through December 31, 2021, there has been no such impairment losses recorded by the Company. (l) Leases At the commencement date of a lease, the Company recognizes lease liabilities which represent its obligation to make lease payments, and right-of-use assets (“ROU assets”) which represent its right to use the underlying asset during the lease term. The lease liability is measured at the present value of lease payments over the lease term. As the Company’s leases typically do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the lease commencement date. The ROU asset is measured at cost, which includes the initial measurement of the lease liability and initial direct costs incurred by the Company and excludes lease incentives. ROU assets are recorded in operating lease ROU assets and lease liabilities are recorded in operating lease liabilities, current and noncurrent in the consolidated balance sheets. F- 9 Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected not to separate lease and non-lease components and not recognize lease liabilities and ROU assets for short-term leases with terms of twelve months or less. (m) Fair Value Option As permitted under Accounting Standards Codification (“ASC”) 825, Financial Instruments , (“ASC 825”), the Company elected the fair value option to account for its convertible promissory notes. In accordance with ASC 825, the Company recorded these convertible promissory notes at fair value with changes in fair value recorded in the statements of operations. As a result of applying the fair value option, costs related to the issuance of the convertible promissory notes were recognized in earnings as incurred and not deferred. (n) Convertible Preferred Stock The Company records convertible preferred stock at fair value on the dates of issuance, net of issuance costs. Upon the occurrence of certain events that are outside the Company’s control, including a deemed liquidation event, holders of the convertible preferred stock can cause redemption for cash. Therefore, convertible preferred stock is classified outside of stockholders’ deficit on the balance sheets as events triggering the liquidation preferences are not solely within the Company’s control. The carrying values of the convertible preferred stock are adjusted to their liquidation preferences if and when it becomes probable that such a liquidation event will occur. (o) Research and Development Expenses Research and development costs are expensed as incurred. Research and development costs consist primarily of salaries and other benefits of research and development personnel, including associated share-based compensation, costs related to research activities, preclinical studies, clinical trial, drug manufacturing and allocated overhead and facility-related expenses. The Company accounts for non-refundable advance payments for goods or services that will be used in future research and development activities as expenses when the goods have been received or when the service has been performed rather than when the payment is made. Clinical trial costs are a component of research and development expenses. The Company expenses costs for its clinical trial activities performed by third parties, including clinical research organizations and other service providers, as they are incurred, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements. The Company uses information it receives from internal personnel and outside service providers to estimate the clinical trial costs incurred. (p) Stock-Based Compensation Stock-based compensation expense represents the cost of the grant-date fair value of employee, officer, director, and non-employee stock option grants, estimated in accordance with the applicable accounting guidance, recognized using the straight-line method over the vesting period for service-based options and using the graded vesting method for performance-based options. The vesting period generally approximates the expected service period of the awards. Forfeitures are recognized and accounted for as they occur. The fair value of stock options is estimated using a Black-Scholes option pricing model on the date of grant. This method requires certain assumptions be used as inputs, such as the fair value of the underlying common stock, expected term of the option before exercise, expected volatility of the Company’s common stock, expected dividend yield, and a risk-free interest rate. Options granted during the year have a maximum contractual term of ten years. The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted using the simplified method, which represents the average of the contractual term of the stock option and its weighted-average vesting period. The expected volatility of stock options is based upon the historical volatility of a number of publicly traded companies in similar stages of clinical development. The Company has historically not declared or paid any dividends and does not currently expect to do so in the foreseeable future. The risk-free interest rates used are based on the U.S. Department of Treasury (“U.S. Treasury”) yield in effect at the time of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the expected term of the stock options. F- 10 (q) Income Taxes Income taxes are accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and net operating loss (“NOL”) and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. (r) Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business as one operating segment. (s) 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: SCHEDULE OF NET LOSS PER SHARE Years Ended December 31, 2021 2020 Numerator: Net loss $ ( 22,963 ) $ ( 9,611 ) Accretion of Series A redeemable convertible preferred stock to redemption value ( 22 ) ( 153 ) Net loss available to common stockholders $ ( 22,985 ) $ ( 9,764 ) Denominator: Weighted-average common stock outstanding, basic and diluted 12,293,629 242,232 Net loss per share, basic and diluted $ ( 1.87 ) $ ( 40.31 ) F- 11 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): SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES NOT INCLUDED IN THE CALCULATION OF DILUTED NET LOSS PER SHARE December 31, 2021 2020 Options to purchase common stock 3,454,374 229,105 Series Seed redeemable convertible preferred stock - 1,287,825 Series A redeemable convertible preferred stock - 2,089,341 3,454,374 3,606,271 (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 December 31, 2021 Quoted Prices in Active Markets for Identical 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 $ - The Company’s cash as of December 31, 2020, of $ 4.6 million, represented a Level 1 asset. F- 12 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 cash, 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 as of December 31, 2021 (in thousands): SUMMARY OF SHORT TERM INVESTMENT 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 As of December 31, 2020, the Company had no short-term investments. 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 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 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 December 31, 2021. Convertible Promissory Notes The Company had no liabilities measured using significant unobservable inputs (Level 3) for the year ended December 31, 2021. The following table presents the changes in estimated fair value of the Company’s Level 3 liabilities for the year ended December 31, 2020 (in thousands): SUMMARY OF RECONCILIATION OF ALL LIABILITIES MEASURED AT FAIR VALUE USING LEVEL 3 SIGNIFICANT UNOBSERVABLE INPUTS Convertible Promissory Notes Balance at December 31, 2019 $ 2,500 Issuance of convertible promissory notes, related party 2,500 Change in fair value of convertible promissory notes, related party 644 Exchange of convertible promissory notes (Note 5) ( 5,644 ) Balance at December 31, 2020 $ - (4) BALANCE SHEET COMPONENTS Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS 2021 2020 December 31, 2021 2020 Prepaid research and development $ 5,233 $ 42 Prepaid expenses 1,485 23 Other current assets 240 38 Total prepaid expenses and other current assets $ 6,958 $ 103 F- 13 Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following (in thousands): SCHEDULE OF ACCRUED AND OTHER CURRENT LIABILITIES 2021 2020 December 31, 2021 2020 Accrued research and development $ 217 $ 946 Accrued payroll and other employee benefits 790 192 Other 143 18 Total accrued and other current liabilities $ 1,150 $ 1,156 (5) CONVERTIBLE PROMISSORY NOTES On December 30, 2019, the Company issued convertible promissory notes (the “2019 Notes”) totaling $ 2.5 million to RA Capital Healthcare Fund, L.P., Blackwell Partners LLC - Series A, and RA Capital Nexus Fund, L.P. (the “Holders”). The 2019 Notes accrued interest at a rate of 6 % per annum and were payable at the demand of the Holders on or after the Maturity Date of December 30, 2021, subject to earlier conversion or repayment in the event of a qualified financing or a change of control, as defined in the convertible promissory notes agreement. Due to certain embedded features, the Company elected to account for the 2019 Notes and all their embedded features under the fair value option. The 2019 Notes were issued at fair value, as such no changes in fair value were recorded between December 30, 2019 and December 31, 2019. The 2019 Notes were converted into Series A redeemable convertible preferred stock in connection with the initial closing of Series A redeemable convertible preferred stock on August 5, 2020, with a conversion price of 80 % of $ 1.893 per share (the “Series A Original Issue Price”). The Company recorded a change in fair value of $ 0.6 million for the period January 1, 2020 through conversion on August 5, 2020. In relation to the 2019 Notes, there was $ 0.1 million of interest expense for the period January 1, 2020 through conversion on August 5, 2020. On July 13, 2020, the Company issued convertible promissory notes (the “2020 Notes”) totaling $ 2.5 million to the Holders. The 2020 Notes accrued interest at a rate of 3 % per annum and were payable at the demand of the Holders on or after the Maturity Date of October 31, 2020 . The 2020 Notes converted into Series A redeemable convertible preferred stock in association with the initial closing of Series A redeemable convertible preferred stock on August 5, 2020. The 2020 Notes were issued at fair value and converted at the Series A Original Issue Price, as such no changes in fair value were recorded with respect to the 2020 Notes. In relation to the 2020 Notes, there was no interest expense for the year ended December 31, 2020. ( 6) 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 had an initial abatement period, and the initial base rent payable is 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 December 31, 2021, the consolidated balance sheet includes an operating lease right-of-use asset of $ 0.5 million and operating lease liability of $ 0.6 million. The total operating lease expense under the Waltham Lease for the year ended December 31, 2021 was $ 68,000 . F- 14 As of December 31, 2021, the future minimum annual lease payments under the operating lease was as follows (in thousands): SCHEDULE OF FUTURE MINIMUM ANNUAL LEASE PAYMENTS FOR OPERATING LEASES 2022 $ 198 2023 221 2024 206 Total operating lease payments 625 Less: Amount representing interest ( 51 ) Total operating lease liabilities $ 574 Weighted-average remaining lease term (in years) 3.0 Weighted-average incremental borrowing rate 6 % (7) STOCKHOLDERS’ EQUITY Under the Company’s Amended and Restated Certificates of Incorporation dated August 3, 2020, the Company had a total of 94,052,154 shares of capital stock authorized for issuance, consisting of 50,000,000 shares of common stock, par value of $ 0.0001 per share, and 44,052,154 shares of convertible preferred stock, par value of $ 0.0001 per share. Shares of authorized convertible preferred stock were designated as 4,000,000 shares of Series Seed redeemable convertible preferred stock and 40,052,154 shares of Series A redeemable convertible preferred stock. Following the Reverse Stock Split, the Company filed a Second Amended and Restated Certificate of Incorporation, which provided for 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, effective upon completion of the Company’s IPO. (a) Redeemable Convertible Preferred Stock In August 2018, the Company sold to RA Capital Health Care Fund, L.P. an aggregate of 4,000,000 shares of Series Seed redeemable preferred stock at a purchase price of $ 1.00 per share, for net proceeds of $ 4.0 million. On August 5, 2020, the Company entered into the Stock Purchase Agreement. The Company’s initial closing of its Series A redeemable convertible preferred stock occurred on this date. The Company issued 3,468,536 shares of Series A redeemable convertible preferred shares for gross proceeds of $ 6.6 million at a price per share of $ 1.893 . In addition to the cash proceeds, 3,020,998 shares of Series A redeemable convertible preferred stock were issued in connection with the conversion of the 2019 Notes and the 2020 Notes. The Stock Purchase Agreement contained provisions that potentially obligate the Company to sell, outside of its control, an additional 33,562,620 shares of Series A redeemable convertible preferred stock at $ 1.893 per share for expected gross proceeds of $ 63.5 million, upon the occurrence of three subsequent Milestone Closings or earlier, at the option of any holder of the Series A redeemable convertible preferred stock. If the defined milestones were not achieved prior to the Company’s initial public offering, the holders had the right to purchase these shares prior to the completion of the initial public offering. If the shares were not purchased prior to the completion of the initial public offering, then this right to purchase these shares would have automatically expired. On February 1, 2021, upon the completion of the First Milestone Closing, the Company sold 4,224,274 shares of Series A redeemable convertible preferred stock at the Series A Original Issue Price for aggregate gross proceeds of $ 8.0 million. On June 4, 2021, upon the completion of the Second Milestone Closing and the Third Milestone Closing, the Company sold 29,338,346 shares of Series A redeemable convertible preferred stock at the Series A Original Issue Price for aggregate gross proceeds of $ 55.5 million. Immediately prior to the closing of the Company’s IPO on July 2, 2021, all outstanding shares of the Company’s redeemable convertible preferred stock converted into 14,182,854 shares of the Company’s common stock. F- 15 (b) Common Stock 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 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 December 31, 2021, the Company had reserved the following shares of common stock for future issuance : SCHEDULE OF COMMON STOCK SHARES RESERVED FOR ON AND AS-CONVERTED BASIS, FOR FUTURE ISSUANCE December 31, 2021 Common stock options granted and outstanding 3,454,374 Reserved for future option grants 1,084,580 Reserved for future ESPP issuances 230,000 Total 4,768,954 (8) SHARE-BASED COMPENSATION (a) Stock Option Plan 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 December 31, 2021, a total of 2,600,000 shares of the Company’s common stock were 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. 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 December 31, 2021, awards with respect to 1,515,420 shares of common stock had been granted under the 2021 Plan, and 1,084,580 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 . F- 16 The following table summarizes the option activity under the 2021 Plan and 2018 Plan for the year ended December 31, 2021: SUMMARY OF OPTION ACTIVITY UNDER 2021 PLAN AND 2018 PLAN 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, 2020 229,105 $ 1.74 9.69 $ - Granted 3,225,269 $ 7.21 9.47 Exercised - - Cancelled/Forfeited - - Outstanding at December 31, 2021 3,454,374 $ 6.85 9.42 $ 19,378 Vested and exercisable at December 31, 2021 268,907 $ 4.81 9.10 $ 2,041 Vested and expected to vest at December 31, 2021 3,454,374 $ 6.85 9.42 $ 19,378 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 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) 1 % 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. 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 December 31, 2021, 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) Stock-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: SUMMARY OF FAIR VALUE OF STOCK OPTIONS ASSUMPTIONS Years Ended December 31, 2021 2020 Expected term (in years) 5.2 - 6.1 5.5 - 6.1 Expected volatility 68.7 % - 69.8 % 68.0  -  79.4 % Risk-free interest rate 0.9 % - 1.4 % 0.4  -  1.5 % Expected dividend - - F- 17 Stock-based compensation expense recognized for stock option grants has been reported in the statements of operations and comprehensive loss as follows (in thousands): SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION GRANTS Years Ended December 31, 2021 2020 Research and development $ 370 $ 30 General and administrative 1,673 28 Total $ 2,043 $ 58 As of December 31, 2021, there was approximately $ 12.6 million of 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 3.4 years. (9) 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, L.P. under which Carnot provides research and other services to the Company. RA Capital Management, L.P. 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, L.P., and the term was updated to the later of (i) two years from July 15, 2019 and (ii) completion of services under the agreement. Expenses incurred by the Company under the Services Agreement with Carnot Pharma totaled $ 0.1 million for the years ended December 31, 2021 and December 31, 2020 and are presented in the statement of operations and comprehensive loss as research and development and general and administrative expenses. As of December 31, 2021 and December 31, 2020, $ 2,000 and $ 6,000 respectively, was due to Carnot Pharma, LLC by the Company for services rendered under the agreement. (10) INCOME TAXES Significant components of the Company’s net deferred tax assets are as follows (in thousands): SUMMARY OF COMPONENTS OF NET DEFERRED TAX ASSETS December 31, 2021 2020 Deferred income tax assets: NOL carryforwards $ 7,498 $ 2,795 Research credit carryforwards 530 41 Other 615 49 Gross deferred tax assets 8,643 2,885 Less: valuation allowance ( 8,517 ) ( 2,885 ) Total deferred tax assets 126 - Deferred income tax liabilities: Other ( 126 ) - Total deferred tax liabilities ( 126 ) - Net deferred tax assets (liabilities) $ - $ - F- 18 A reconciliation between the provision for income taxes and income taxes computed using the U.S. federal statutory corporate tax rate is as follows (in thousands): SUMMARY OF RECONCILIATION OF FEDERAL INCOME TAX RATE Years ended December 31, 2021 2020 U.S. Federal statutory income tax rate $ ( 4,821 ) $ ( 2,018 ) State taxes ( 520 ) ( 89 ) Permanent and other differences 3 52 Convertible promissory notes - 151 Stock-based compensation 115 10 Research and development credits ( 392 ) - Change in valuation allowance 5,618 1,894 Total tax provision $ 3 $ - The Company had federal NOL carryforwards available of $ 32.6 million and $ 12.0 million as of December 31, 2021 and December 31, 2020, respectively, before consideration of limitations under Section 382 of the Internal Revenue Code or Section 382, as further described below. The NOL generated from 2018 onwards of $ 32.6 million will carryforward indefinitely and be available to offset up to 80% of future taxable income each year . Additionally, the Company had state NOL carryforwards available of $ 13.4 million and $ 7.3 million as of December 31, 2021 and December 31, 2020, respectively. The state NOLs may be used to offset future taxable income and will begin to expire in 2034 . Additionally, as of December 31, 2021, the Company had federal and state research and development credit carryforwards available of $ 0.6 and $ 0.1 million as of December 31, 2021 and December 31, 2020 that will begin to expire in 2038. The Company has established a full valuation allowance for its deferred tax assets due to uncertainties that preclude it from determining that it is more likely than not that the Company will be able to generate sufficient taxable income to realize such assets. Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to utilize the existing deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred since inception. Such objective evidence limits the ability to consider other subjective evidence such as the Company’s projections for future growth. Based on this evaluation, as of December 31, 2021 and December 31, 2020, a valuation allowance of $ 8.5 million and $ 2.9 million, respectively, has been recorded against all of the Company’s net deferred tax assets, as the Company has determined that none of the Company’s balance of net deferred tax assets is more likely than not to be realized. The amount of the deferred tax assets considered realizable, however, could be adjusted in the future if objective negative evidence in the form of cumulative losses is no longer present and additional weight may be given to subjective evidence, such as estimates of future taxable income during carryforward periods and the Company’s projections for growth. The future utilization of the Company’s NOL and tax credit carryforwards to offset future taxable income may be subject to a substantial annual limitation as a result of changes in ownership by stockholders that hold 5% or more of the Company’s common stock. An assessment of such ownership changes under Section 382 and 383 was not completed through December 31, 2021. Utilization of our net operating loss and income tax credit carryforwards may be subject to a substantial annual limitation due to ownership changes that may have occurred or that could occur in the future. These ownership changes may limit the amount of the net operating loss and income tax credit carryover that can be utilized annually to offset future taxable income. The Company will examine the impact of any potential ownership changes in the future. F- 19 The following table summarizes the activity related to the Company’s gross unrecognized tax benefits at the beginning and end of the years ended December 31, 2021 and December 31, 2020 (in thousands): SUMMARY OF GROSS UNRECOGNIZED TAX BENEFITS Years ended December 31, 2021 2020 Beginning balance of unrecognized tax benefits $ 276 $ - Additions based on tax positions related to the current year 253 276 Ending balance of unrecognized tax benefits $ 529 $ 276 The unrecognized tax benefit amounts are reflected in the determination of the Company’s deferred tax assets. If recognized, none of these amounts would affect the Company’s effective tax rate, since it would be offset by an equal corresponding adjustment in the deferred tax asset valuation allowance. The Company does not foresee material changes to its liability for uncertain tax benefits within the next twelve months. The Company is subject to taxation in the United States and various states. The Company’s Federal and state returns are subject to examination, as 2018 was the first year of operations for the Company. F- 20 EXHIBIT INDEX Exhibit Number Description 3.1 Second Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-40544) filed with the SEC on July 2, 2021). 3.2 Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-40544) filed with the SEC on July 2, 2021). 4.1 Form of Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 4.2 Investors’ Rights Agreement among the Registrant and certain of its stockholders, dated August 5, 2020 (incorporated by reference to Exhibit 4.2 to the Registrant’s Registration Statement on Form S-1 (File No. 333-256949) filed with the SEC on June 9, 2021). 4.3* Description of Securities. 10.1# 2018 Equity Incentive Plan, and form of award agreements thereunder (incorporated by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-256949) filed with the SEC on June 9, 2021). 10.2# 2021 Stock Option and Incentive Plan, and form of award agreements thereunder (incorporated by reference to Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.3# 2021 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.4# Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.5# Form of Indemnification Agreement between the Registrant and each of its directors and executive officers (incorporated by reference to Exhibit 10.5 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.6# Form of Employment Agreement (incorporated by reference to Exhibit 10.6 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.7# Senior Executive Cash Incentive Bonus Plan (incorporated by reference to Exhibit 10.10 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.11 Lease, dated August 6, 2021, by and between the Registrant and PDM 930 Unit, LLC (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-40544) filed with the SEC on August 12, 2021). 21.1* List of Subsidiaries of Registrant. 23.1* Consent of KPMG LLP, Independent Registered Public Accounting Firm. 24.1* Power of Attorney (included on signature page). 102 31.1* Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 31.2* Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 32.1** Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 32.2** Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 101.INS* Inline XBRL Instance Document 101.SCH* Inline XBRL Taxonomy Extension Schema Document 101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document 101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document 104 Cover Page Interactive Data File * Filed herewith. # Indicates a management contract or compensatory plan, contract or arrangement. ** The certifications furnished in Exhibit 32.1 and 32.2 hereto are deemed to accompany this Annual Report on Form 10-K and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certifications will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference. 103 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized . AEROVATE THERAPEUTICS, INC. Date: March 30, 2022 By: /s/ Timothy P. Noyes Timothy P. Noyes Chief Executive Officer Each person whose individual signature appears below hereby authorizes and appoints Timothy P. Noyes and George A. Eldridge, and each of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file any and all amendments to this annual report on Form 10-K and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his substitute or substitutes may lawfully do or cause to be done by virtue thereof. Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report on Form 10-K has been signed below by the following persons on behalf of the Registrant in the capacities and on March 30, 2022. Name Title Date /s/ Timothy P. Noyes Chief Executive Officer and Director March 30, 2022 Timothy P. Noyes (Principal Executive Officer) /s/ George A. Eldridge Chief Financial Officer March 30, 2022 George A. Eldridge (Principal Financial Officer and Principal Accounting Officer) /s/ Mark Iwicki Director March 30, 2022 Mark Iwicki /s/ Allison Dorval Director March 30, 2022 Allison Dorval /s/ David Grayzel, M.D. Director March 30, 2022 David Grayzel, M.D. /s/ Maha Katabi, Ph.D. Director March 30, 2022 Maha Katabi, Ph. D. /s/ Joshua Resnick, M.D. Director March 30, 2022 Joshua Resnick, M.D. 104