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Tyra Biosciences Inc

For the period ended Sep 30, 2024. Filed Nov 7, 2024.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2024 · Filed Nov 7, 2024

TYRA$21.15+1.2%Stored close · as of Nov 6, 2026

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Notes to the Condensed Financial Statements

  1. Organization and Basis of Presentation

Organization

Tyra Biosciences, Inc. (the Company) was incorporated in the state of Delaware on August 2, 2018. The Company is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology. The Company’s in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. The Company’s initial focus is on applying its accelerated small molecule drug discovery engine to develop therapies in targeted oncology and genetically defined conditions.

Basis of Presentation

The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States (GAAP) for interim financial information and pursuant to the instructions of the Securities and Exchange Commission (SEC) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB). The unaudited condensed financial statements include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows. The results for the three and nine months ended September 30, 2024 and 2023 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period. The condensed balance sheet at September 30, 2024 has been derived from the financial statements at that date but does not include all disclosures required by GAAP for complete financial statements. Because all of the disclosures required by GAAP for complete financial statements are not included herein, these unaudited condensed financial statements and the notes accompanying them should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

Summary of Significant Accounting Policies

During the three and nine months ended September 30, 2024, there have been no changes to the Company's significant accounting policies as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

Fair Value Measurements

The Company measures cash equivalents and available-for-sale debt securities at fair value. 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. Therefore, fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. Fair value is affected by a number of factors, including the type of asset or liability, the characteristics specific to the asset or liability and the state of the marketplace including the existence and transparency of transactions between market participants. 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—Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.

Level 2—Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability.

Level 3—Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e. supported by little or no market activity).

Money market funds are highly liquid investments and are classified as Level 1. The pricing information for these assets is readily available and can be independently validated as of the measurement date. Available-for sale debt securities are valued using observable inputs from similar assets, or from observable data in markets that are not active. These assets are classified as Level 2.

Marketable Securities

Marketable securities consist of debt securities of government-sponsored entities. These securities are classified as available-for sale, as the sale of such securities may be required prior to their maturity. Available-for-sale securities are recorded at fair value, with the related unrealized gains and losses included in accumulated other comprehensive income or loss and included as a separate component of stockholders' equity. The amortized cost of available-for-sale securities reflects amortization of premiums and accretion of discounts to maturity. Premiums and discounts on debt securities are amortized into interest and other income, net. The Company classifies investments in marketable debt securities as current assets, regardless of the stated maturity date, which may be beyond one year from the current balance sheet date. Short-term classification reflects management's view that the entire portfolio is available and the Company may use the proceeds from sales of these investments to fund current operations, as necessary.

Restricted Cash

Restricted cash is comprised of cash that is restricted as to its withdrawal or use under the terms of certain contractual agreements. Restricted cash as of both September 30, 2024 and December 31, 2023 was$1.0 million, which consisted of collateral for letters of credit related to the Company’s operating leases.

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and common stock equivalents outstanding for the period. Common stock equivalents are only included when their effect is dilutive. Pre-funded warrants are considered outstanding for the purposes of computing basic and diluted net loss per share because shares may be issued for little or no additional consideration and are fully vested and exercisable after the original issuance date of the pre-funded warrant. The Company’s potentially dilutive securities include unvested common stock, unvested common stock upon early exercise of stock options, outstanding stock options under the Company’s equity incentive plan, and estimated shares purchasable under the employee stock purchase plan, and have been excluded from the computation of diluted net loss per share as their inclusion would be antidilutive. 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.

Commitments and Contingencies

The Company recognizes a liability with regard to loss contingencies when it believes it is probable a liability has been incurred, and the amount can be reasonably estimated. If some amount within a range of loss appears at the time to be a better estimate than any other amount within the range, the Company accrues that amount. When no amount within the range is a better estimate than any other amount the Company accrues the minimum amount in the range.

Recently Issued Accounting Pronouncements

On August 5, 2020, the Financial Accounting Standards Board (FASB) issued ASU 2020-06, “Debt - Debt With Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40)”, which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU is part of the FASB’s simplification initiative, which aims to reduce unnecessary complexity in GAAP. For smaller reporting companies, this ASU is effective for fiscal years beginning after December 15, 2023. The Company adopted this standard effective January 1, 2024, which did not have a material impact on the Company's condensed financial statements.

Issued Accounting Pronouncements Not Yet Adopted

In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740): 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, with early adoption permitted. The Company is currently evaluating the impact of this guidance on its condensed financial statements.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 updates reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for all entities for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The amendments should be applied retrospectively to all prior periods presented in the financial statements. The Company operates as a single segment and does not expect ASU 2023-07 to have a material impact on its condensed financial statements.

  1. Fair Value Measurements

The following tables show the Company’s cash, cash equivalents, marketable securities and restricted cash measured at fair value as of September 30, 2024 and December 31, 2023 (in thousands):

TotalQuoted prices in active markets for identical assets (Level 1)Significant other observable inputs (Level 2)Significant unobservable inputs (Level 3)
Cash and cash equivalents:
Cash and money market funds$103,892$103,892$—$—
Restricted cash:
Cash1,0001,000——
Marketable securities:
U.S. Treasury securities118,043—118,043—
U.S. government agency securities138,195—138,195—
Total marketable securities256,238—256,238—
Total$361,130$104,892$256,238$—
TotalQuoted prices in active markets for identical assets (Level 1)Significant other observable inputs (Level 2)Significant unobservable inputs (Level 3)
Cash and cash equivalents:
Cash and money market funds$58,006$58,006$—$—
Restricted cash:
Cash1,0001,000——
Marketable securities:
U.S. Treasury securities95,599—95,599—
U.S. government agency securities49,864—49,864—
Total marketable securities145,463—145,463—
Total$204,469$59,006$145,463$—

The carrying amounts of the Company’s prepaid and other current assets, accounts payable, and accrued and other current liabilities, approximate fair value due to their short maturities. None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. There were no transfers between Levels 1, 2 or 3 for any of the periods presented.

  1. Marketable Securities

The following tables summarize the Company's marketable securities (see below and Note 2) accounted for as available-for-sale securities (in thousands, except years):

Maturity (in years)Amortized costUnrealized gainsUnrealized lossesEstimated fair value
U.S. Treasury securities1 or less$58,846$157$—$59,003
U.S. government agency securities1 or less101,969373(1)102,341
U.S. Treasury securities1-258,274766—59,040
U.S. government agency securities1-235,397457—35,854
Total$254,486$1,753$(1)$256,238
Maturity (in years)Amortized costUnrealized gainsUnrealized lossesEstimated fair value
U.S. Treasury securities1 or less$76,481$153$—$76,634
U.S. government agency securities1 or less37,37638(3)37,411
U.S. Treasury securities1-218,846118—18,964
U.S. government agency securities1-212,37975—12,454
Total$145,082$384$(3)$145,463

The following tables present fair values and gross unrealized losses for those available-for-sale securities that were in an unrealized loss position, aggregated by category and the length of time that the securities have been in a continuous loss position (in thousands):

Unrealized losses less than 12 monthsUnrealized losses 12 months or greaterTotal
Fair valueUnrealized lossesFair valueUnrealized lossesFair valueUnrealized losses
U.S. government agency securities$2,998$(1)$—$—$2,998$(1)
Total$2,998$(1)$—$—$2,998$(1)
Unrealized losses less than 12 monthsUnrealized losses 12 months or greaterTotal
Fair valueUnrealized lossesFair valueUnrealized lossesFair valueUnrealized losses
U.S. government agency securities$9,939$(3)$—$—$9,939$(3)
Total$9,939$(3)$—$—$9,939$(3)

As of September 30, 2024, there wasone available-for-sale security with an estimated fair value of$3.0 million in a gross unrealized loss position for less than 12 months. As of September 30, 2024, unrealized losses on available-for-sale securities are not attributed to credit risk. The Company believes that an allowance for credit losses is unnecessary because the unrealized loss is due to market factors and interest rate fluctuations. Additionally, the Company does not intend to sell the security nor is it more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis.

Accrued interest on the Company's available-for-sale securities was $1.9 million as of September 30, 2024 and is included in prepaid and other current assets on the condensed balance sheet.

  1. Property and Equipment

Property and equipment consisted of the following (in thousands):

September 30,2024December 31,2023
Equipment$1,875$1,443
Computers and software242208
Leasehold improvements469402
Furniture and fixtures382382
2,9682,435
Less: accumulated depreciation(1,179)(807)
Total property and equipment, net$1,789$1,628

The Company recognized$0.1 million and$0.4 million in depreciation expense for the three and nine months ended September 30, 2024, respectively, and$0.1 million and$0.3 million in depreciation expense for the three and nine months ended September 30, 2023, respectively.

  1. Accrued and Other Current Liabilities

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

September 30,2024December 31,2023
Accrued payroll and other employee benefits$3,787$5,117
Accrued research and development6,3314,848
Accrued legal and professional fees196132
Accrued other general and administrative fees496294
Total accrued and other current liabilities$10,810$10,391
  1. Stockholders' Equity

Common Stock

Common stock reserved for future issuance consisted of the following:

September 30,2024December 31,2023
Common stock options granted and outstanding10,751,0838,276,442
Shares available for future issuance under the 2021 Incentive Award Plan2,922,8063,677,313
Shares available for future issuance under the 2021 Employee Stock Purchase Plan1,491,1951,129,399
Pre-Funded Warrants issued and outstanding under the 2024 Private Placement6,087,230—
Total common stock reserved for future issuance21,252,31413,083,154

On October 3, 2022, the Company entered into an ATM Sales Agreement (the Sales Agreement) with Virtu Americas LLC (the Agent), under which the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from the Company of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. As of September 30, 2024, no shares of common stock were issued and sold pursuant to the Sales Agreement since inception.

Private Placement

On February 1, 2024, the Company entered into a securities purchase agreement (the February 2024 SPA) for a private placement of 9,286,023 shares of the Company's common stock at a price of$13.01 per share (the 2024 Private Placement). The February 2024 SPA also included pre-funded warrants (the 2024 Pre-Funded Warrants) to purchase an aggregate of 6,087,230 shares of common stock at a purchase price of$13.009 per pre-funded warrant. Each pre-funded warrant has an exercise price of $0.001 per share of common stock, is immediately exercisable on the date of issuance and will not expire. The 2024 Private Placement closed on February 6, 2024 and the Company received gross proceeds of approximately$200 million, before deducting offering expenses of $0.4 million. On March 19, 2024, the Company filed a registration statement on Form S-3 with the SEC registering the resale of the shares of common stock issued, or underlying the pre-funded warrants issued, in the 2024 Private Placement. There wereno exercises of the 2024 Pre-Funded Warrants during thethree and nine months ended September 30, 2024. The 2024 Pre-funded Warrants did not meet the characteristics of a liability or a derivative and are classified within stockholders' equity.

  1. Equity Incentive Plans and Stock-Based Compensation

2021 Incentive Award Plan

In September 2021, the Company's Board of Directors adopted, and its stockholders approved, the 2021 Incentive Award Plan (the 2021 Plan). Upon the adoption of the 2021 Plan, the Company restricted the grant of future equity awards under the 2020 Equity Incentive Plan (the 2020 Plan).

The 2021 Plan provides for the grants of stock options and other equity-based awards to employees, non-employee directors, and consultants of the Company. A total of 5,570,000 shares of the Company’s common stock were initially reserved for issuance pursuant to the 2021 Plan, consisting of 4,537,850 shares reserved under the 2021 Plan and 1,032,150 shares of the Company’s common stock that remained available for issuance under the 2020 Plan. The 2021 Plan share reserve increased by the number of shares under the 2020 Plan that were repurchased, forfeited, expired or cancelled after the effective date of the 2021 Plan. In addition, the number of shares of the Company’s common stock available for issuance under the 2021 Plan automatically increases on the first day of each fiscal year, beginning with the Company’s 2022 fiscal year, in an amount equal to the lesser of (1)5% of the outstanding shares of the Company’s common stock on the last day of the immediately preceding fiscal year, or (2) such smaller amount as determined by the Company’s Board of Directors. On January 1, 2024, the shares available for grant under the 2021 Plan were increased by 2,154,952. As of September 30, 2024,2,922,806 shares were available for future grant under the 2021 Plan.

A summary of the Company’s stock option activity for the period ended September 30, 2024 was as follows (in thousands, except share and per share data and years):

OptionsWeighted-AverageExercisePrice per ShareWeighted-AverageRemainingContractual TermAggregateIntrinsic Value
Outstanding at December 31, 20238,276,442$10.078.3$40,420
Granted2,926,848$20.62
Exercised(434,818)$3.05
Cancelled(17,389)$8.26
Outstanding at September 30, 202410,751,083$13.238.3$110,998
Exercisable at September 30, 20244,510,940$9.707.3$62,669
Vested and expected to vest as of September 30, 202410,751,083$13.238.3$110,998

Stock-Based Compensation Expense

The Company estimated the fair value of stock options using the Black-Scholes valuation model. The Company accounts for 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:

Nine Months EndedSeptember 30,
20242023
Risk-free rate of interest3.5 - 4.6%3.5 - 4.3%
Expected term (years)5.3 - 6.15.2 - 6.1
Expected stock price volatility87.8 - 98.7%87.0 - 92.3 %
Dividend yield——

Stock-based compensation expense recognized for all equity awards has been reported in the condensed statements of operations and comprehensive loss as follows (in thousands):

Three Months EndedSeptember 30,Nine Months EndedSeptember 30,
2024202320242023
Research and development expense$5,329$2,811$10,462$5,749
General and administrative expense2,2441,5665,6373,590
Total$7,573$4,377$16,099$9,339

The weighted-average grant date fair value of options granted for the nine months ended September 30, 2024 and 2023 was$15.96 and$10.01 per share, respectively.

During the three months ended September 30, 2024, the Company entered into a transition agreement (the Transition Agreement) with its Chief Medical Officer. The Transition Agreement included accelerated vesting of 50% of unvested stock options and extended the exercise period of vested options from three months totwo years from the separation date. As a result, the Company recognized an additional stock-based compensation expense of $2.0 million recorded within research and development expenses, including $1.2 million related to accelerated vesting and incremental stock-based compensation of $0.8 million resulting from modified option terms.

For the nine months ended September 30, 2024 and 2023, forfeitures resulting in the reversal of compensation expenses were immaterial.

As of September 30, 2024, the unrecognized compensation cost related to outstanding employee and nonemployee options was$71.7 million, and is expected to be recognized as expense over a weighted-average period of approximately 2.7 years.

Employee Stock Purchase Plan

In September 2021, the Company’s Board of Directors and stockholders approved and adopted the 2021 Employee Stock Purchase Plan (ESPP). The ESPP became effective on the business day immediately prior to the effective date of the Company’s first registration statement. A total of 380,000 shares of the Company’s common stock were initially reserved for issuance pursuant to the ESPP. In addition, the number of shares of the Company’s common stock available for issuance under the ESPP will automatically increase on the first day of each fiscal year, beginning with the Company’s 2022 fiscal year, in an amount equal to the lesser of (1)1% ofthe outstanding shares of the Company’s common stock on the last day of the immediately preceding fiscal year, or (2) such smaller amount as determined by the Company’s Board of Directors. On January 1, 2024, the number of shares reserved for issuance under the ESPP was increased by 430,990 shares.

The ESPP permits eligible employees who elect to participate in an offering under the ESPP to have up to 15% of their eligible earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the ESPP. The price of common stock purchased under the ESPP is equal to 85% of the lower of the fair market value of the common stock at the commencement date of each offering period or the relevant date of purchase. Each offering period is 24 months, with new offering periods commencing every six months on or about the dates of March 15 and September 15 of each year. During thenine months ended September 30, 2024 and 2023, the Company issued 69,194 and 56,387 shares, respectively, of common stock in connection with the ESPP. As of September 30, 2024, there were 1,491,195 shares available for future purchase under the ESPP.

The Company recognized compensation expense of $0.1 million and $0.1 million for the three months ended September 30, 2024 and 2023, respectively, and $0.2 million and$0.4 million for the nine months ended September 30, 2024 and 2023, respectively, related to the ESPP. As of September 30, 2024, the remaining unrecognized compensation expense related to the ESPPwas $0.4 million, and is expected to be recognized as expense over a weighted-average period of approximately 1.7 years.

  1. Net Loss Per Share

The following table sets forth the computation of the basic and diluted net loss per share (in thousands, except share and per share amounts):

Three Months EndedSeptember 30,Nine Months EndedSeptember 30,
2024202320242023
Numerator:
Net loss$(24,016)$(21,152)$(60,910)$(46,304)
Denominator:
Weighted-average common shares outstanding58,898,27743,020,96556,638,73242,822,677
Less: weighted-average unvested restricted common stock subject to repurchase—(2,107)—(2,762)
Less: weighted-average unvested common stock issued upon early exercise of common stock options(23,780)(150,518)(39,682)(200,840)
Weighted-average shares used to compute net loss per common share, basic and diluted58,874,49742,868,34056,599,05042,619,075
Net loss per share, basic and diluted$(0.41)$(0.49)$(1.08)$(1.09)

Included in the weighted-average shares of common stock outstanding, both basic and diluted for the three and nine months ended September 30, 2024 are weighted shares of common stock issuable upon the exercise of the 2024 Pre-Funded Warrants issued under the 2024 Private Placement (described in Note 6). The 2024 Pre-Funded Warrants are exercisable at any time for nominal consideration, and therefore these shares are considered outstanding for the purpose of calculating basic and diluted net loss per share.

Thefollowing table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because their inclusion would be anti-dilutive.

As of September 30,
20242023
Unvested restricted common stock subject to repurchase—1,865
Unvested common stock upon early exercise of stock options17,265124,644
Options to purchase common stock10,751,0838,110,570
Estimated shares purchasable under the ESPP1,5573,865
10,769,9058,240,944
  1. Leases

The Company has operating leases for its office and laboratory space, including its corporate headquarters.

In August 2020, the Company entered into a lease agreement for approximately 4,734 square feet of office and lab space at 2656 State Street in Carlsbad, California, for the Company’s headquarters (the Original Lease). The Original Lease commenced in May 2021 and had an original term of 60 months, with an option to extend fortwo additional 36-month periods.

In March 2022, the Company entered into a lease agreement for approximately 8,331 square feet of additional office and laboratory space at 2676 State Street in Carlsbad, California (the Expansion Lease). The Expansion Lease commenced for accounting purposes when the Company gained access to the premises in May 2023. The Company's obligation for payment of base rent began on the date the landlord delivered possession of the Expansion Lease premises in November 2023. The landlord completed improvements on the Expansion Lease premises, and the Company paid $0.5 million of these costs prior to the Expansion Lease commencement. The Company has concluded that the landlord is the accounting owner of these improvements, and therefore this payment has been included in the calculation of the right-of-use asset and lease liability. The Company is entitled to certain rent abatement for delays related to the landlord's delivery of the Expansion Lease premises to the Company. The Expansion Lease has a lease term of 120 months, starting on the day the landlord delivered possession of the Expansion Lease premises. The Company has an option to renew the Expansion Lease for two additional 36-month periods. The Original Lease was also amended to have the same lease expiration as the Expansion Lease.

The Company did not include the renewal periods in determining the lease term, as the Company was not reasonably certain to exercise either the amended Original Lease or the Expansion Lease renewal options.

In connection with the Company's lease agreements, the Company paid security deposits of $0.1 million and is required to maintain a letter of credit of $1.0 million. The letter of credit may be reduced to $0.9 million in 2027 and further reduced to $0.5 million in 2028.

Cash paid for amounts included in the measurement of lease liabilities was $0.2 million and $0.1 million for the three months ended September 30, 2024 and 2023, respectively, and $0.5 million and $0.8 million for the nine months ended September 30, 2024 and 2023, respectively.

The components of lease expense include operating, short-term, and variable lease costs. Amortization is recorded within research and development and general and administrative expenses in the condensed statements of operations and comprehensive loss. Components of lease cost for thethree and nine months ended September 30, 2024 and 2023, respectively, were as follows (in thousands):

Three Months EndedSeptember 30,Nine Months EndedSeptember 30,
2024202320242023
Operating lease cost$240$227$718$473
Short-term lease cost21196939
Variable lease cost32199553
Total lease cost$293$265$882$565

Maturitiesof lease liabilities, weighted-average remaining term and weighted-average discount rate were as follows (in thousands):

As of September 30,
Year ending December 31,
2024 (remaining three months)$216
2025874
2026900
2027927
2028955
Thereafter5,032
Total minimum lease payments8,904
Less: amount representing interest(2,586)
Present value of lease liabilities6,318
Less: current portion of lease liabilities(398)
Lease liabilities, noncurrent$5,920
September 30,December 31,
20242023
Weighted-average remaining lease term (years) - operating leases9.29.9
Weighted-average incremental borrowing rate - operating leases8.07%8.07%
  1. Commitments and Contingencies

Other Funding Commitments

As of September 30, 2024, the Company had ongoing clinical and pre-clinical studies for its various pipeline programs. The Company enters into contracts in the normal course of business with contract research organizations in preparation for clinical trials, professional consultants for expert advice and other vendors for clinical supply manufacturing or other services. These contracts are generally cancellable, with notice, at the Company's option and do not have significant cancellation penalties.

Litigation

The Company, from time to time, may be party to litigation arising in the ordinary course of business. The Company was not subject to any material legal proceedings as of September 30, 2024, and no material legal proceedings are currently pending or threatened. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount is reasonably estimable, the Company will accrue a liability for the estimated loss.

  1. Subsequent Events

On October 18, 2024, the Company entered into an exchange agreement with Boxer Capital, LLC and RA Capital Healthcare Fund, L.P. pursuant to which (i) Boxer Capital, LLC agreed to exchange 2,000,000 shares of the Company’s common stock for one or more pre-funded warrants to acquire an aggregate of 2,000,000 shares of common stock and (ii) RA Capital Healthcare Fund, L.P. agreed to exchange 1,000,000 shares of common stock for one or more pre-funded warrants to acquire an aggregate of 1,000,000 shares of common stock. Each pre-funded warrant has an exercise price of $0.001 per share of common stock, is immediately exercisable on the date of issuance and will not expire. No cash was exchanged related to the transaction. The exchange closed on October 22, 2024.

Subsequent to September 30, 2024,705,043 Pre-Funded Warrants issued under the 2024 Private Placement were exercised in a cashless transaction, which resulted in 705,000 shares of common stock being issued to the investor.

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