What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2024-03-25 compared with 2023-03-29 · 80 added, 96 removed, 621 unchanged (22% of the section changed)

14 unchanged sentences

● provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our financial statements.

Under the supervision of and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework provided in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in (2013 Framework).

Organizations of the Treadway Commission in (2013 Framework).

Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2023.

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Other Information.

On March 27, 2023, we delivered written notice to Jefferies LLC, or Jefferies, that we were terminating the Open Market Sale Agreement dated August 15, 2022, or the Sales Agreement, by and between us and Jefferies, effective as of a date no later than 10 trading days from the date of delivery, the Termination Date.

All of the continuing obligations under the Sales Agreement will be terminated as of the Termination Date, other than those provisions which expressly survive termination as provided in the Sales Agreement.

We are not subject to any termination penalties related to the termination of the Sales Agreement.

Prior to termination, no shares of our common stock, $0.0001 par value per share, were sold pursuant to the Sales Agreement.

A copy of the Sales Agreement was filed as Exhibit 1.2 to our Registration Statement on Form S-3 (File No.

333-266883) filed with the SEC on August 15, 2022.

Rule 10b5-1 Plans

On November 16, 2023 , Benjamin Dake , our President , adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) (the Dake 10b5-1 Plan).

Between March 18, 2024 and December 31, 2024, the Dake 10b5-1 Plan provides for the potential sale of approximately 193,530 of our common stock.

The plan expires on December 31, 2024 , or upon the earlier completion of all authorized transactions under the plan .

On November 17, 2023 , Marinus Verwijs , our Chief Technology Officer , adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1 (c) (the Verwijs 10b5-1 Plan).

Between March 19, 2024 and October 1, 2024, the Verwijs 10b5-1 Plan provides for the potential sale of approximately 42,400 of the our common stock.

The plan expires on December 31, 2024 , or upon the earlier completion of all authorized transactions under the plan.

On November 24, 2023 , Timothy Noyes , our Chief Executive Officer , adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1 (c) (the Noyes 10b5-1 Plan).

Between April 1, 2024 and July 16, 2025, the Noyes 10b5-1 Plan provides for the potential sale of approximately 280,000 of our common stock.

The plan expires on July 31, 2025 , or upon the earlier completion of all authorized transactions under the plan.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

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Consolidated Statements of Operations and Comprehensive Loss

Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

Consolidated Statements of Stockholders’ Equity

Consolidated Statements of Cash Flows

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We have audited the accompanying consolidated balance sheets of Aerovate Therapeutics, Inc.

and subsidiary (the Company) as of December 31, 2022 and 2021, 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).

and subsidiary (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, stockholders’ equity 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, 2023 and 2022, and the results of its operations and its cash flows for the years then ended, in conformity with U.S.

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Additional paid-in capital

Accumulated other comprehensive loss

Accumulated other comprehensive income (loss)

Accumulated deficit

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Other comprehensive loss:

Unrealized loss on securities

Unrealized gain (loss) on securities

Comprehensive loss

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AEROVATE THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(IN THOUSANDS, EXCEPT SHARE AMOUNTS)

Series A Redeemable

Stockholders’

Preferred Stock

Comprehensive

Stockholders’

(Loss) Income

Balance at December 31, 2021

Issuance of Series A redeemable convertible preferred stock at $ 1.893 per share, net of issuance costs of $ 22

Accretion of Series A redeemable convertible preferred stock to redemption value

Conversion of redeemable convertible preferred stock to common stock upon initial public offering

( 40,052,154 )

( 4,000,000 )

Issuance of common stock upon initial public offering, net of issuance costs

Unrealized loss on investments

Stock based compensation

Issuance of common stock upon exercise of stock options

Issuance of common stock under ESPP

Balance at December 31, 2022

Unrealized loss on investments

Unrealized gain on investments

Stock based compensation

Issuance of common stock in connection with ATM, net

Vesting of restricted stock units

Issuance of common stock upon exercise of stock options

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Purchases of short-term investments

Sales and maturities of short-term investments

Maturities of short-term investments

Purchases of property and equipment

Net cash provided by (used in) investing activities

Net cash provided by investing activities

Cash flow from financing activities:

Proceeds from sale of Series A redeemable convertible preferred stock, net of issuance costs

Payments for deferred offering costs

Proceeds from sale of common stock in connection with ATM, net

Payments for offering costs

Proceeds from issuance of common stock under ESPP

Proceeds from exercise of stock options

Proceeds from issuance of common stock, net of issuance costs

Proceeds from issuance of common stock upon exercise of stock options

Net cash provided by financing activities

Net (decrease) increase in cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Cash and cash equivalents at the beginning of the year

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Deferred offering costs included in accounts payable

Purchases of property and equipment in accounts payable

Conversion of redeemable convertible preferred stock to common stock upon initial public offering

See accompanying notes to consolidated financial statements.

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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 global Phase 2b/Phase 3 trial of AV-101 in adults with PAH in December 2021.

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.

The Company initiated a global Phase 2b/Phase 3 trial of AV-101 in adults with PAH in December 2021 and announced in November 2023 completion of enrollment of the Phase 2b portion of this trial and enrollment of the first patient in the Phase 3 portion of this trial.

At-the-Market Offering

On August 15, 2022, we entered into an Open Market Sale Agreement SM , or the Sale Agreement, with Jefferies LLC, or the Agent, pursuant to which we can sell, from time to time, at our option, up to an aggregate of $ 75.0 million of shares of our common stock, through the Agent, as our sales agent.

As of December 31, 2022, no shares were sold under the Sale Agreement.

On April 5, 2023, the Company entered into an ATM Equity Offering SM Sales Agreement, or the Sales Agreement, with BofA Securities, Inc., or the Agent, pursuant to which the Company can sell, from time to time, at its option, up to an aggregate of $ 75.0 million of shares of its common stock, through the Agent, as its sales agent.

As of December 31, 2023, 2,662,721 shares have been sold under the Sales Agreement, generating approximately $ 44.3 million of net proceeds after deducting commissions to the sales agent and other offering costs, and up to $ 30.0 million of shares of the Company’s common stock remain available for sale from time to time under the Sales Agreement.

Liquidity and Management Plans

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All intercompany transactions and balances have been eliminated in consolidation.

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.

Use of Estimates

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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.

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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.

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.

Concentration of Credit Risk

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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 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:

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Stock-Based Compensation

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.

Stock-based compensation expense represents the cost of the grant-date fair value of employee, officer, director, and non-employee stock option grants and restricted stock units, 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.

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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.

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.

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Year Ended December 31,

Accretion of Series A redeemable convertible preferred stock to redemption value

Net loss available to common stockholders

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Recently Issued Accounting Pronouncements

In December 2023, the FASB issued ASU No.

2023-09, "Improvements to Income Tax Disclosures." ASU 2023-09 requires disaggregated information about a reporting entity's effective tax rate reconciliation as well as

information on income taxes paid.

ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024 and for private businesses for annual periods beginning after December 15, 2025, with early adoption permitted.

The Company is currently evaluating the impact of this guidance on its financial statement disclosures.

In June 2022, the FASB issued ASU No.

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Treasury bills

Corporate debt securities

Total short-term investments

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Money market funds

Commercial paper

Total cash equivalents

Short-term investments

Treasury bills

Corporate debt securities

Commercial paper

Treasury bills

Total short-term investments

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Estimated fair

2 years or less

Commercial paper

1 year or less

2 years or less

Treasury bills

2 years or less

Corporate debt securities

2 years or less

1 unchanged sentence

Estimated fair

Corporate debt securities

1 year or less

Commercial paper

1 unchanged sentence

Treasury bills

1 year or less

2 years or less

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Treasury bills

Corporate debt securities

As of December 31, 2022

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Total Unrealized

Corporate debt securities

Commercial paper

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

As of December 31,

Prepaid expenses

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

As of December 31,

Accrued research and development

8 unchanged sentences

The Waltham Lease commencement date was September 1, 2021.

In January 2024, the Company entered into the First Amendment to the Waltham Lease resulting in the lease expiring on December 31, 2025, and an increase of $ 1.00 per rentable square foot during the additional lease term.

In obtaining this lease extension, the Company no longer has the option to extend the Waltham Lease for one additional period of three years .

In April 2022, the Company entered into a lease agreement (the “Foster City Lease”) for approximately 3,500 square feet of office space in Foster City, California.

The Foster City Lease has a term of thirty-nine months , unless extended or earlier terminated.

The Company has the option to extend the Foster City Lease for on additional period of one year .

The Company has the option to extend the Foster City Lease for on

additional period of one year .

The base rent payable under the Lease Term will be $ 22,600 per month and will be subject to annual increase of 3 % on each anniversary.

As of December 31, 2023, the consolidated balance sheet includes an operating lease right-of-use asset of $ 0.6 million and operating lease liability of $ 0.7 million.

The total operating lease expense was $ 0.4 million and $ 0.1 million, for the years ended December 31, 2022 and 2021, respectively.

The total operating lease expense was $ 0.4 million for both of the years ended December 31, 2023 and 2022.

As of December 31, 2023, the future minimum annual lease payments under the operating leases were as follows (in thousands):

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The components of operating leases for the years ended December 31, 2023 and December 31, 2022 were as follows (in thousands except lease term and discount rate):

As of December 31,

Operating lease liabilities:

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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.

(b) Common Stock

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 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.

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.

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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.

The number of shares available under the 2021 Plan increased by 976,415 and 988,918 shares, effective January 1, 2022 and January 1, 2023, respectively, as determined by the Company’s board of directors.

Since adoption, the annual increases have accumulated to a total of 3,075,841 shares through January 1, 2024.

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, 2022, 2,467,977 options had been granted and 28,881 restricted stock units awarded under the 2021 Plan, with 1,077,557 shares authorized for future issuance.

As of December 31, 2023, 3,931,887 options had been granted under the 2021 Plan, with 604,363 shares authorized under the 2021 Plan available for future issuance.

As of December 31, 2023, a total of 1,298,457 options had been granted and were outstanding under the 2018 Plan.

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As of December 31, 2023, 31,881 restricted stock units had been awarded under the 2021 Plan.

A summary of the status of and changes in unvested restricted stock unit activity under the Company’s equity award plans for the nine months ended December 31, 2022 was as follows:

A summary of the status of and changes in unvested restricted stock unit activity under the Company’s equity award plans for the year ended December 31, 2023, was as follows:

Average Grant

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As of December 31, 2023, the Company had unrecognized stock-based compensation expense related to its unvested restricted stock units of $ 0.9 million, which is expected to be recognized over the remaining weighted-average vesting period of 2.4 years.

The Company did not incur or have any unrecognized stock-based compensation related to restricted stock units as of December 31, 2021.

(d) Stock-Based Compensation Expense

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Year Ended December 31,

General and administrative

Research and development

General and administrative

Stock-based compensation expense by type of award included within the consolidated statements of operations and comprehensive (loss) income was as follows:

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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 less than $ 0.1 million and $ 0.1 million for the years ended December 31, 2022 and December 31, 2021, respectively, 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, $ 2,000 was due to Carnot Pharma, LLC by the Company for services rendered under the agreement, and no amount was due to Carnot Pharma, LLC as of December 31, 2022.

Expenses incurred by the Company under the Services Agreement with Carnot Pharma totaled $ 0 and less than $ 0.1 million for the years ended December 31, 2023 and December 31, 2022, respectively, and are presented in the statement of operations and comprehensive loss as research and development and general and administrative expenses.

No amount was due to Carnot Pharma, LLC as of December 31, 2023 and December 31, 2022.

(9) INCOME TAXES

4 unchanged sentences

Capitalized R&D

Stock based compensation

Gross deferred tax assets

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Based on this evaluation, as of December 31, 2023 and December 31, 2022, a valuation allowance of $ 43.6 million and $ 23.3 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 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.

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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.

The Company’s Federal and state returns are subject to examination, due to the carryforward of unutilized net operating losses and research and development credits.

EXHIBIT INDEX

25 unchanged sentences

001-40544) filed with the SEC on August 12, 2021).

Lease, Amendment, dated January 2, 2024, by and between the Registrant and PDM 930 Unit, LLC .

Lease, dated April 26, 2022, by and between the Registrant and Hudson Metro Center, 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 April 29, 2022) .

ATM Equity Offering SM Sales Agreement, dated as of April 5, 2023, by and between Aerovate Therapeutics, Inc.

and BofA Securities, Inc.

(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 April 5, 2023).

Aerovate Therapeutics, Inc.

Insider Trading Policy.

List of Subsidiaries of Registrant (incorporated by reference to Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K (File No.

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Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Compensation Recovery Policy (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-40544) filed with the SEC on August 14, 2023).

Inline XBRL Instance Document

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Accounting Officer)

/s/ Mark Iwicki

/s/ Habib Dable

March 25, 2024

5 unchanged sentences

David Grayzel, M.D

/s/ Mark Iwicki

March 25, 2024

/s/ Maha Katabi, Ph.D.

7 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures