Biomea Fusion Inc
For the period ended Dec 31, 2023. Filed Mar 28, 2024.
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FY2023 · Filed Mar 28, 2024
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Notes to Financial Statements
Note 1. Organization
Organization
Biomea Fusion, Inc., (the Company), was established in the state of Delaware in August 2017 as Biomea Fusion, LLC. In December 2020, all outstanding membership interests in Biomea Fusion, LLC were converted into equity interests in the Company. The capitalization information included in these financial statements is consistently presented as if it is that of Biomea Fusion, Inc., even during the prior period when investors held their equity interests in Biomea Fusion, LLC.
The Company is a clinical-stage biopharmaceutical company dedicated to discovering and developing oral novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases. Since its inception in 2017, the Company has built its proprietary FUSIONTM System platform to design and develop a pipeline of novel covalent product candidates.
Follow-On Offering
On April 3, 2023, the Company issued and sold 5,750,000 shares of common stock, which included 750,000 shares sold pursuant to the exercise of the underwriters’ over-allotment option, at a public offering price of $30.00 per share in an underwritten public offering pursuant to a shelf registration on Form S-3. The net proceeds to the Company from the offering were $161.8 million, after deducting underwriting discounts and commissions and offering costs of $10.7 million.
Liquidity and Capital Resources
The accompanying financial statements have been prepared assuming the Company will continue as a going concern, which assumes the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company believes that based on its current operating plan, its cash and cash equivalents, restricted cash, and investments will not enable it to fund its operating expenses and capital expenditure requirements for at least twelve months following the issuance date of the financial statements. The Company’s ability to continue as a going concern will require the Company to raise additional capital to fund the Company's operations through public or private equity offering, debt financings, collaborations and licensing arrangements or other sources. There can be no assurance that additional financing will be available to the Company or that such financing, if available, will be available on terms acceptable to the Company. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern. The Company has incurred net operating losses and negative cash flows from operations since its inception and had an accumulated deficit of$248.8 million at December 31, 2023. As of December 31, 2023, the Company had cash, cash equivalents, and restricted cash of$177.2 million.
The Company has historically financed its operations primarily through the sale of convertible preferred stock and common stock and the issuance of unsecured promissory notes. To date, none of the Company’s product candidates have been approved for sale, and the Company has not generated any revenue since inception. Management expects operating losses to continue and increase for the foreseeable future, as the Company progresses into clinical development activities for its lead product candidate and advances the preclinical and clinical development of other product candidates. The Company’s prospects are subject to risks, expenses and uncertainties frequently encountered by companies in the biotechnology industry. Failure to generate sufficient cash flows from operations or raise additional capital would have a material adverse effect on the Company’s ability to achieve its intended business objectives.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
These financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP).
Use of Estimates
Thepreparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company evaluates its estimates, including, but not limited to, those related to clinical and preclinical accruals, manufacturing accruals, fair value of common stock, stock-based compensation, operating lease right-of-use (ROU) assets and liabilities and income taxes. The Company bases its estimates on its historical experience and also on assumptions that it believes are reasonable; however, actual results could significantly differ from those estimates.
Segments
The Company operates and manages its business asone reportable and operating segment, which is the business of developing covalent small molecule drugs to treat patients with genetically defined cancers and metabolic diseases. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for allocating resources and evaluating financial performance. All long-lived assets are maintained in, and all losses are attributable to, the United States of America.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a concentration of credit risk, consist primarily of cash, cash equivalents and investments. The Company maintains bank deposits in federally insured financial institutions and these deposits may exceed federally insured limits. The Company invests in money market funds, U.S. Treasury securities, U.S. government agency securities, corporate notes, commercial paper, and asset backed securities. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash and cash equivalents and issuers of investments to the extent recorded in the balance sheet. The Company’s investment policy limits investments to money market funds, certain types of debt securities issued by the U.S. Government and its agencies, corporate notes and commercial paper, and places restrictions on the credit ratings, maturities and concentration by type and issuer. The Company has not experienced any losses on its deposits of cash, cash equivalents and investments.
Other Risks and Uncertainties
The Company’s future results of operations involve a number of other risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of preclinical studies, clinical trials and achievement of milestones, uncertainty of regulatory approval of the Company’s potential product candidates, uncertainty of market acceptance of the Company’s product candidates, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals or sole source suppliers and changes in the Company's operating expenses as a result of these uncertainties and other factors, such as inflation. The Company’s product candidates require approvals from the U.S. Food and Drug Administration and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company.
Cash, Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be cash and cash equivalents. Cash equivalents consist of amounts invested in money market accounts and are stated at fair value. Restricted cash consists oftwo stand-by letters of credit issued to the Company’s landlord in connection with two of the Company’s leases.
Investments
The Company adopted Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments, on January 1, 2023. The Company’s investments have been classified as available-for-sale and carried at estimated fair values and reported in cash equivalents, short-term investments, or long-term investments. Management determines the appropriate classification of the investments at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. Investments with contractual maturities greater than 12 months are considered long-term investments.
For available-for-sale debt securities in an unrealized loss position, the Company first assesses whether it intends to sell, or whether it is more likely than not that it will be required to sell the security before the recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value and recognized in interest and other income, net in the statement of operations and comprehensive loss. If neither criteria is met, the Company evaluates whether the decline in fair value is related to credit-related factors or other factors. In making this assessment, management considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and adverse conditions specifically related to the security, among other factors. Credit-related impairment losses, limited by the amount that the fair value is less than the amortized cost basis, are recorded through an allowance for credit losses in interest and other income, net.
Any unrealized losses from declines in fair value below the amortized cost basis as a result of non-credit factors are recognized in accumulated other comprehensive loss, net of tax as a separate component of stockholders’ equity, along with unrealized gains. Realized gains and losses and declines in fair value, if any, on available-for-sale securities are included in interest and other income, net in the statement operations and comprehensive loss.
For purposes of identifying and measuring credit-related impairments, the Company’s policy is to exclude applicable accrued interest from both the fair value and amortized cost basis of the related security. The Company has elected to write-off uncollectible accrued interest receivable balances in a timely manner, which is defined by the Company as when interest due becomes 90 days delinquent. The accrued interest write-off will be recorded by reversing interest income. Accrued interest receivable is recorded in other current assets on the condensed balance sheets.
Property and Equipment, Net
Property and equipment are recorded at cost net of accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. The useful lives of property and equipment are as follows:
| Computer equipment | 3 years |
|---|---|
| Furniture and fixtures | 5 years |
| Laboratory equipment | 5 years |
| Leasehold improvements | Shorter of remaining lease term or estimated useful life |
Upon retirement or sale of the assets, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is recorded to the statements of operations. Repairs and maintenance are expensed as incurred.
Impairment of Long-Lived Assets
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. There wasno impairment of long-lived assets during the years ended December 31, 2023, 2022 and 2021.
The Company expenses research and development costs as they are incurred. Research and development expenses consist primarily of: (i) personnel-related expenses, including salaries, benefits and stock-based compensation expense, for personnel in the Company’s research and development functions; (ii) fees paid to third parties such as contractors, consultants and contract research organizations (CROs), for animal studies and other costs related to preclinical and clinical testing; (iii) costs related to acquiring and manufacturing research and clinical trial materials, including under agreements with third parties such as contract manufacturing organizations (CMOs), and other vendors; (iv) costs related to the preparation of regulatory submissions; (v) expenses related to laboratory supplies and services; and (vi) depreciation of equipment and facilities expenses.
Accrued Research and Development Expenses
The Company records accruals for estimated costs of research, preclinical studies, clinical trials, and manufacturing development, which are significant components of research and development expenses. A substantial portion of the Company’s ongoing research and development activities is conducted by third-party service providers, CROs and CMOs. The Company’s contracts with the CROs and CMOs generally include fees such as initiation fees, reservation fees, costs related to animal studies and safety tests, verification run costs, materials and reagents expenses, investigator fees, taxes, etc. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company accrues the costs incurred under agreements with these third parties based on estimates of actual work completed in accordance with the respective agreements. The Company determines the estimated costs through discussions with internal personnel and external service providers as to the progress, or stage of completion and actual timeline (start-date and end-date) of the services and the agreed-upon fees to be paid for such services. Through December 31, 2023, there have been no material differences from the Company’s estimated accrued research and development expenses to actual expenses.
Stock-Based Compensation
The Company accounts for stock-based compensation by measuring and recognizing compensation expense for all share-based awards made to employees, non-employees and directors based on estimated grant-date fair values. The Company uses the straight-line method to allocate compensation cost to reporting periods over the requisite service period, which is generally the vesting period, and estimates the fair value of share-based awards to employees, non-employees and directors using the Black-Scholes option-pricing model. The Company uses the “simplified” method to estimate the expected term. The Company utilizes this method as our stock options qualify as "plain-vanilla" options. The Company accounts for forfeitures as they occur. The fair value of restricted stock awards is based on grant-date fair value. The fair value of each purchase under the employee stock purchase plan (ESPP) is estimated at the beginning of the offering period using the Black-Scholes option pricing model and recorded as expense over the service period using the straight-line method.
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presented.
Leases
The Company determines if an arrangement is a lease at inception in accordance with Accounting Standard Codification 842, “Leases” (ASC 842). As of December 31, 2023, the Company's lease population consisted of real estate leases and the Company did not have finance leases.
Operating leases are included in operating lease right-of-use (ROU) assets, current operating lease liabilities and non-current operating lease liabilities on the Company’s balance sheet. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. As most of the Company's leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of those lease payments. The Company determines the incremental borrowing rate based on an analysis of corporate bond yields with a credit rating similar to the Company. The determination of the Company’s incremental borrowing rate requires management judgment including the development of a synthetic credit rating and cost of debt as the Company currently does not carry any debt. The Company believes that the estimates used in determining the incremental borrowing rate are reasonable based upon current facts and circumstances. Applying different judgments to the same facts and circumstances could result in the estimated amounts to vary. The operating lease ROU assets also include adjustments for prepayments and accrued lease payments and exclude lease incentives. Lease incentives are recognized prospectively, on reimbursement, as reduction to the right-of-use asset and lease liabilities over the lease term. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise such options. Operating lease cost is recognized on a straight-line basis over the expected lease term. Variable lease costs represent payments that are dependent on usage, a rate or index. Variable lease cost primarily relates to common area maintenance charges. Lease agreements that include lease and non-lease components are accounted for as a single lease component. The Company has elected to apply the short-term lease exception for all lease agreements with a noncancelable term of less than 12 months.
Income Taxes
The Company began providing for income taxes under the asset and liability method in December 2020 upon conversion from a limited liability company into a corporation. Current income tax expense or benefit represents the amount of income taxes expected to be payable or refundable for the current year. Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and tax basis of assets and liabilities and net operating loss and credit carryforwards and are measured using the enacted tax rates and laws that will be in effect when such items are expected to reverse. Deferred income tax assets are reduced, as necessary, by a valuation allowance when management determines it is more likely than not that some or all the tax benefits will not be realized.
The Company accounts for uncertain tax positions in accordance with ASC No. 740 Income Taxes. The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available.
The Company includes any penalties and interest expense related to income taxes as a component of income tax expense, as necessary.
Recent Accounting Pronouncements - Adopted
In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which requires that financial assets measured at amortized cost be presented at the net amount expected to be collected. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss methodology, which will result in more timely recognition of credit losses. The measurement of expected credit losses is based on historical experience, current conditions, and reasonable and supportable forecasts that affect collectability. This ASU also eliminates the concept of “other-than-temporary” impairment when evaluating available-for-sale debt securities and instead focuses on determining whether any impairment is a result of a credit loss or other factors. An entity will recognize an allowance for credit losses on available-for-sale debt securities rather than an other-than-temporary impairment that reduces the cost basis of the investment. This ASU is effective for fiscal years beginning after December 15, 2022 and interim periods within those fiscal years. The Company adopted ASU 2016-13 on January 1, 2023, using the modified retrospective approach, and no cumulative effect adjustment to accumulated deficit was needed as of the adoption date. Additionally, no prior period amounts were adjusted and continue to be reported in accordance with the legacy other-than-temporary impairment model. The adoption of ASU 2016-13 did not have a material impact on the Company’s financial statements.
Recent Accounting Pronouncements - Not Yet Adopted
In December 2023, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2023-09, “Income Taxes - Improvements to Income Tax Disclosures” requiring enhancements and further transparency to certain income tax disclosures, most notably the tax rate reconciliation and income taxes paid. This ASU is effective for fiscal years beginning after December 15, 2024 on a prospective basis and retrospective application is permitted. The Company is currently evaluating the impact of the adoption of this standard on the Company’s financial statements and related disclosures.
Note 3. Fair Value Measurement
The Company applies fair value accounting for all financial assets and liabilities. Fair value is 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, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
Level 1—Observable inputs, such as quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
The carrying amount of cash and cash equivalents, prepaid expenses, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of the short-term nature of these instruments.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company classifies money market funds as Level 1 within the fair value hierarchy as the fair value is based on quoted price in active markets. The Company classifies its investments in corporate debt securities, commercial paper and asset backed securities as Level 2 within the fair value hierarchy as the fair value is based on other observable inputs, including broker or dealer quotations or alternative pricing sources. When quoted prices in active markets for identical assets or liabilities are not available, the Company relies on non-binding quotes from its investment managers, which are based on proprietary valuation models of independent pricing services. These models generally use inputs such as observable market data, quoted market prices for similar instruments, or historical pricing trends of a security relative to its peers. To validate the fair value determination provided by its investment managers, the Company reviews the pricing movement in the context of overall market trends and trading information from its investment managers. In addition, the Company assesses the inputs and methods used in determining the fair value in order to determine the classification of securities in the fair value hierarchy. As of December 31, 2023 and 2022, there wereno financial instruments classified as Level 3. The Company evaluates transfers between levels at the end of each reporting period and there wereno transfers of financial instruments between the fair value measurement levels during the year ended December 31, 2023.
As of December 31, 2023, investments measured and recognized at fair value are as follows (in thousands):
| FairValueHierarchyLevel | AmortizedCost | UnrealizedGains | UnrealizedLosses | Fair Value | |
|---|---|---|---|---|---|
| Financial assets included within cash and cash equivalents: | |||||
| Money market funds | Level 1 | $174,429 | $— | $— | $174,429 |
| Total | $174,429 | $— | $— | $174,429 | |
| FairValueHierarchyLevel | AmortizedCost | UnrealizedGains | UnrealizedLosses | Fair Value | |
|---|---|---|---|---|---|
| Financial assets included within cash and cash equivalents: | |||||
| Money market funds | Level 1 | $105,684 | $— | $— | $105,684 |
| Financial assets included within short-term investments: | |||||
| Corporate notes | Level 2 | 1,151 | — | (1) | 1,150 |
| Total | $106,835 | $— | $(1) | $106,834 | |
As of December 31, 2022, all debt securities with an unrealized loss position have been in a loss position for less than one year. The aggregate fair value of debt securities in an unrealized loss position as of December 31, 2022 was $1.2 million with no individual securities in a significant unrealized loss position. The Company evaluated its securities for other-than-temporary impairment as of December 31, 2022, and considered the decline in market value to be primarily attributable to current economic and market conditions and would not be required to sell the securities before recovery of the amortized cost basis. Based on this analysis, these marketable securities were not considered to be other-than-temporarily impaired as of December 31, 2022. As there wereno unrealized losses as of December 31, 2023, no allowance for credit losses has been recognized as of December 31, 2023. During the years ended December 31, 2023 and 2022, the Company didnot recognize any impairment losses related to investments.
Note 4. Balance Sheet Components
Property and Equipment, Net
Property and equipment, net consists of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Laboratory equipment | $3,852 | $2,331 |
| Computer equipment | 130 | 130 |
| Furniture and fixtures | 409 | 325 |
| Leasehold improvements | 3,195 | 801 |
| Construction in progress | 4 | 3,170 |
| Total property and equipment, gross | 7,590 | 6,757 |
| Less: accumulated depreciation | (2,431) | (916) |
| Total property and equipment, net | $5,159 | $5,841 |
Depreciation expense was approximately$1.5 million,$0.7 million $0.2 million for the years ended December 31, 2023, 2022 and 2021, respectively.
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Accrued research and development materials and services | $6,952 | $6,039 |
| Accrued personnel expenses | 5,956 | 4,774 |
| Accrued professional services | 443 | 208 |
| Other | 192 | 636 |
| Total accrued expenses and other current liabilities | $13,543 | $11,657 |
Note 5. Capital Structure
Common Stock
In December 2020, all of the outstanding membership interests in Biomea Fusion LLC were exchanged for equity interests in Biomea Fusion, Inc. in a statutory conversion under Delaware law. All of the share information referenced throughout the financial statements and notes to the financial statements have been retroactively adjusted to reflect the change in capital structure.
In connection with the completion of its IPO, on April 20, 2021, the Company’s certificate of incorporation was amended and restated to authorize 300,000,000 shares of common stock with a par value of $0.0001 per share and 10,000,000 shares of preferred stock with a par value of $0.0001 per share.
Common stockholders are entitled to dividends when and if declared by the Company’s Board of Directors and after any preferred share dividends are fully paid. The holder of each share of common stock is entitled to one vote. As of December 31, 2023 and 2022, no dividends have been declared.
The Company had reserved common stock for future issuance as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Stock options, issued and outstanding | 7,357,607 | 5,341,975 |
| Stock options, authorized for future issuance | 799,485 | 1,446,872 |
| Employee stock purchase plan, available for future issuance | 451,886 | 402,747 |
| Restricted stock, issued and outstanding | 111,920 | 292,236 |
| Total | 8,720,898 | 7,483,830 |
Note 6. Stock-Based Compensation
2020 Equity Incentive Plan
The Company adopted the 2020 Equity Incentive Plan (the “2020 Plan”) on December 18, 2020. The 2020 Plan reserved 4,327,799 shares of common stock to grant stock-based compensation awards, including stock options and restricted stock awards, to employees and non-employees. As of April 9, 2021, the Company ceased granting awards under the 2020 Plan. However, 2020 Plan awards will remain subject to the terms of the 2020 Plan.
2021 Equity Incentive Plan
In April 2021, the Company adopted the 2021 Equity Incentive Plan (the “2021 Plan”). Options granted under the 2021 Plan expire no later than 10 years from the date of grant. The exercise price of options granted under the 2021 Plan must at least be equal to the fair market value of the Company’s common stock on the date of grant. With respect to any participant who owns more than 10% of the voting power of all classes of the Company’s outstanding stock, the term of an incentive stock option granted to such participant must not exceed five years and the exercise price must equal at least 110% of the fair market value on the grant date. Employee stock options generally vest 1/16 th quarterly over four years subject to continued service to the Company.
Subject to adjustment in the case of certain capitalization events as provided in the 2021 Plan, the Company initially reserved 3,370,000 shares of the Company’s common stock for issuance pursuant to awards under the 2021 Plan. The 2021 Plan is administered by the Compensation Committee of the Company’s Board of Directors. The number of shares of the Company’s common stock available for issuance under the 2021 Plan will also include an annual increase on the first day of each fiscal year beginning in 2022 and ending in 2031, equal to the lesser of (i)5% of the Company’s common stock outstanding at December 31 of the immediately preceding year, or (ii) such number of shares as determined by the Company’s Board of Directors. As of December 31, 2023,799,485 shares of common stock remained available for issuance under the 2021 Plan. Effective January 1, 2024, the number of shares of common stock available under the 2021 Plan increased by 1,798,926 shares pursuant to the evergreen provision of the 2021 Plan.
2023 Inducement Plan
On November 17, 2023, the Company's board of directors adopted the 2023 Inducement Equity Plan (Inducement Plan) pursuant to which the Company reserved 2,000,000 shares of common stock, to be used exclusively for grants of equity-based awards to individuals who were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The Inducement Plan provides for the grant of equity-based awards in the form of non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance stock unit awards, unrestricted stock awards, dividend equivalent rights or Other Stock Based Awards (as defined in the Inducement Plan). The Inducement Plan was adopted by the board of directors without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. As of December 31, 2023,2,000,000 sharesof common stock remained available for issuance under the Inducement Plan.
2021 Employee Stock Purchase Plan
The Company adopted a 2021 Employee Stock Purchase Plan (ESPP) in April 2021. The ESPP enables eligible employees of the Company and designated affiliates to purchase shares of common stock at a discount of 15%. Subject to adjustment in the case of certain capitalization events, a total of 306,000 common shares of the Company were available for purchase at adoption of the ESPP. Pursuant to the ESPP, the annual share increase pursuant to the evergreen provision is determined based on the lesser of (i)1% of the Company’s common stock outstanding at December 31 of the immediately preceding year, or (ii) such number of shares as determined by the Company’s Board of Directors. As of December 31, 2023,451,886 shares of common stock remained available for issuance under the ESPP. Effective January 1, 2024, the number of shares of common stock available under the ESPP increased by 359,785 shares pursuant to the evergreen provision of the ESPP.
Stock-Based Compensation Expense
Total stock-based compensation expense related to the 2020 Plan, 2021 Plan, and ESPP was recorded in the statements of operations and allocated as follows (in thousands):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Research and development | $6,933 | $4,678 | $2,637 |
| General and administrative | 7,198 | 5,658 | 3,597 |
| Total stock-based compensation expense | $14,131 | $10,336 | $6,234 |
As of December 31, 2023, there was$27.6 million of total unrecognized compensation cost related to stock options, restricted stock awards, and ESPP under the Plans. The unrecognized stock-based compensation cost is expected to be recognized over a weighted-average period of 2.3 years.
Stock Options
The following table summarizes stock option activity:
| Number of Options Outstanding | Weighted-AverageExercisePrice | Weighted-AverageRemainingContractualTerm(Years) | Aggregate Intrinsic Value(in thousands) | |
|---|---|---|---|---|
| Balance as of December 31, 2022 | 5,341,975 | $8.79 | 8.6 | $6,875 |
| Granted | 2,441,795 | 10.66 | ||
| Exercised | (125,192) | 7.48 | ||
| Cancelled | (300,971) | 11.14 | ||
| Balance as of December 31, 2023 | 7,357,607 | $9.34 | 8.1 | $42,071 |
| Options exercisable as of December 31, 2023 | 3,471,556 | $8.87 | 7.7 | $20,783 |
The fair value of stock options was estimated using the following weighted-average assumptions:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Expected term in years | 6.0 | 6.0 | 6.0 |
| Expected volatility | 79.9% | 93.1% | 91.0% |
| Risk-free interest rate | 3.8% | 3.1% | 1.1% |
| Dividend yield | — | — | — |
| Weighted average fair value of options granted | $7.57 | $5.25 | $7.28 |
The aggregate intrinsic value of options exercised for the years ended December 31, 2023, 2022, 2021 was$1.7 million,$0.4 million, and $0.5 million, respectively. Intrinsic values are calculated as the difference between the exercise price of the underlying options and the fair value of the common stock on the date of exercise.
Employee Stock Purchase Plan
The fair value of ESPP was estimated using the following weighted-average assumptions:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Expected term in years | 1.3 | 1.3 | 1.3 |
| Expected volatility | 80.9% | 95.2% | 91.3% |
| Risk-free interest rate | 4.9% | 2.5% | 0.3% |
| Dividend yield | — | — | — |
Restricted Stock
The Company granted 824,429 restricted stock awards to employees and non-employees during the fourth quarter of 2020 that vest quarterly over four years. Restricted stock awards are share awards that entitle the holder to receive freely tradeable shares of the Company’s common stock. The underlying shares are outstanding as of the issuance date. Any unvested shares are subject to forfeiture in the case that the grantee’s service terminates prior to vesting of the restricted stock.
The following table summarizes the restricted stock activity:
| Number of Restricted Stock Awards | Weighted-AverageGrant Date Fair Value | |
|---|---|---|
| Balance, December 31, 2022 | 292,236 | $4.04 |
| Granted | — | — |
| Released | (180,316) | 4.02 |
| Forfeited | — | — |
| Balance, December 31, 2023 | 111,920 | $4.06 |
Note 7. Taxes
Biomea Fusion is subject to U.S. federal and state income taxes as a corporation. Prior to the tax-free reorganization in December 2020, Biomea Fusion, LLC was treated as a pass-through entity for U.S. federal income tax purposes, and as such, was generally not subject to U.S. federal income tax at the entity level. Rather, the tax liability with respect to its taxable income, was passed through to its unitholders.
There waszero income tax expense for the years ended December 31, 2023, 2022 and 2021. The following is a reconciliation of the statutory federal income tax rate to the Company’s effective tax rate:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Federal statutory income tax rate | 21.0% | 21.0% | 21.0% |
| State income tax rate | 11.1% | 0.5% | 0.5% |
| Tax credits | 4.1% | 1.1% | 0.2% |
| Stock-based compensation | (1.0)% | (1.1)% | (1.5)% |
| Amortization | — | — | 2.6% |
| Change in valuation allowance | (34.6)% | (21.5)% | (22.7)% |
| Other | (0.6)% | — | (0.1)% |
| Effective income tax rate | 0.0% | 0.0% | 0.0% |
Deferred tax assets and liabilities consist of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Deferred tax assets: | ||
| Net operating loss carryforwards | $31,469 | $12,100 |
| Capitalized research and development | 25,055 | 10,326 |
| Accrued liabilities and reserves | 1,562 | 411 |
| Stock-based compensation | 4,602 | 1,887 |
| Intangible assets | 1,607 | 1,129 |
| Operating lease liabilities | 2,857 | 480 |
| Research and development credits | 7,400 | 1,633 |
| Gross deferred tax assets | 74,552 | 27,966 |
| Valuation allowance | (71,512) | (27,432) |
| Total deferred tax assets | 3,040 | 534 |
| Deferred tax liabilities: | ||
| Property and equipment | (344) | (82) |
| Operating lease right-of-use assets | (2,696) | (452) |
| Total deferred tax liabilities | (3,040) | (534) |
| Net deferred tax assets | $— | $— |
The provisions of ASC Topic 740, Accounting for Income Taxes (ASC 740), require an assessment of both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable. For the years ended December 31, 2023 and 2022, based on all available objective evidence, including the existence of cumulative losses, the Company determined that it was not more likely than not that the net deferred tax assets were fully realizable. Accordingly, the Company established a full valuation allowance against its deferred tax assets. The Company intends to maintain a full valuation allowance on net deferred tax assets until sufficient positive evidence exists to support reversal of the valuation allowance. The Company’s valuation allowance increased by$44.2 million during the year ended December 31, 2023, primarily because of an increase to the Company's credits, stock compensation and capitalization of research and experimental expenses. In addition the Company was granted approval from the California Franchise Tax Board to utilize an alternative apportionment method to calculate the Company's California net operating losses which increased the Company's state net operating loss carryforward. The Company’s valuation allowance increased by$17.7 million during the year ended December 31, 2022, primarily because of an increase to the Company's net operating losses, credits, stock compensation and the capitalization of research and development expenses.
At December 31, 2023, the Company had net operating loss carryforwards available to reduce future taxable income, if any, for federal and state income tax purposes of approximately$84.5 million and$197.1 million, respectively. The federal net operating loss carryforwards at December 31, 2023 can be carried forward indefinitely, subject to an annual limitation of 80% of taxable income. The state net operating loss carryforward are subject to expiration in various tax years.
At December 31, 2023, the Company also had federal and California research and development tax credit carryforwards of$7.4 million and$2.7 million, respectively, available to offset future income tax, if any. The federal credit carryforwards begins expiring in 2040, and the California credits can be carried forward indefinitely.
Under Section 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change,” the corporation's ability to use its pre-change net operating loss carryforwards and other pre-change attributes, such as research tax credits, to offset its post-change income may be limited. In general, an “ownership change” will occur if there is a cumulative change in the Company's ownership by “5-percent shareholders” that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws. Therefore, certain of the Company's carryforward tax attributes may be subject to an annual limitation regarding their utilization against taxable income in future periods. The Company has performed a Section 382 study and has concluded that ownership changes have occurred. As a result, the federal and state NOL carryforwards and tax credit carryforwards may be subject to annual limitations before being applied to reduce future income tax liabilities.
Uncertain Tax Positions
The Company adopted the provisions of ASC 740, which requires companies to determine whether it is “more likely than not” that a tax position will be sustained upon examination by the appropriate taxing authorities before any tax benefit can be recorded in the financial statements. It also provides guidance on the recognition, measurement, classification and interest and penalties related to uncertain tax positions.
The following table summarizes the activity related to the Company’s gross unrecognized tax benefits (in thousands):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Beginning balance | $624 | $112 | $— |
| Increases for tax provisions related to prior year | 227 | 133 | 1 |
| Increases for tax provisions related to current year | 1,365 | 379 | 111 |
| Ending balance | $2,216 | $624 | $112 |
The unrecognized tax benefits, if recognized, would not affect the effective income tax rate due to the valuation allowance that currently offsets deferred tax assets. Interest and penalties were zero. The Company does not expect the unrecognized tax benefits to change significantly over the next twelve months.
The Company files federal and state income tax returns. All periods since inception are subject to examination by federal and state authorities, where applicable. There are currently no pending income tax examinations.
Note 8. Commitments and Contingencies
Operating Leases
The Company leases its headquarters with its main offices and laboratory facilities in Redwood City and San Carlos, California.
In September 2022, the Company entered into athirty-month sub-lease agreement for office space located at 900 Middlefield Road, 4th Floor, Redwood City, California, which commenced in January 2023 and expires in July 2025. In connection with the sub-lease, the Company made a security deposit of $2.1 million which is included in other assets on the balance sheet at December 31, 2023. Upon commencement, the Company recognized a right-of-use asset and lease liability of $6.0 million, discounted at 11.5%, the Company’s estimated incremental borrowing rate.
In November 2021, the Company entered into afour-year lease for additional lab space located at 1585 Industrial Road, San Carlos, California which commenced in January 2023 and expires in January 2027. Under the provisions of the agreement, upon the commencement date, the term of the lab space located at 1599 Industrial Road, San Carlos, California (1599 lease), was also extended from April 2026 to January 2027. The lease included a renewal option for an additional five years until January 2032, which has been included in the determination of the right-of-use as of December 31, 2023. As the term of the 1599 lease was extended, this did not result in a separate contract, accordingly, the Company remeasured the right-of-use asset and lease liability totaling to $7.8 million under one lease, discounted at 11.4%, the Company’s estimated incremental borrowing rate. In addition, the lease included a lease incentive in the form of a tenant improvement allowance of up to $1.5 million. In November 2023, the Company submitted a claim of approximately $1.5 million against tenant improvement allowance reimbursement in connection with its operating lease for lab space located at 1585 Industrial Road, San Carlos, California which was received in January 2024. Of the total reimbursement, approximately $0.4 million constitutes a loan required to be repaid in the form of additional lease payments over the remaining lease term at an annual interest rate of 7%, which requires remeasurement of lease liability and related right-of-use asset on receipt. The Company has determined that impact of the remeasurement to be immaterial. The remaining $1.1 million are recognized as receivable as of December 31, 2023 and are presented as a reduction of the operating lease liabilities on the balance sheet at December 31, 2023.
The following table summarizes the lease costs and cash paid for the Company’s leases (in thousands):
| December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Cash paid for operating lease liabilities | $2,469 | $700 | $346 |
| Operating lease costs | 4,099 | 711 | 482 |
| Short-term lease costs | — | 2,921 | 671 |
| Variable lease costs | 1,326 | 357 | 105 |
Supplemental balance sheet information related to operating leases is as follows:
| December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Weighted average remaining lease term | 5.6 | 3.3 | 4.3 |
| Weighted average discount rate | 10.9% | 5.4% | 5.4% |
Maturities of lease liabilities as of December 31, 2023 were as follows (in thousands):
| Operating Lease | |
|---|---|
| Year Ending December 31, | Commitments |
| 2024 | 4,054 |
| 2025 | 2,757 |
| 2026 | 1,380 |
| 2027 | 1,431 |
| 2028 | 1,474 |
| Thereafter | 4,826 |
| Total undiscounted lease payments | 15,922 |
| Less: Present value adjustments | (4,488) |
| Less: Tenant improvement allowance yet to be received | (1,138) |
| Total operating lease liabilities | $10,296 |
| Operating lease liabilities, current | 2,466 |
| Operating lease liabilities, non-current (1) | 7,830 |
| Total operating lease liabilities (1) | $10,296 |
(1) Total operating lease liabilities are presented net of tenant improvement allowances yet to be received which exceeds the minimum lease payments to be paid over the next 12 months. As such, the current portion of the related lease liability is fully reduced and the noncurrent portion of the related lease liability is reduced by the remaining portion of the lease incentive yet to be received.
Legal Proceedings
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 during the years ended December 31, 2023 and 2022, and, to the best of its knowledge, no material legal proceedings are currently pending or threatened.
Indemnification
The Company enters into standard indemnification agreements in the ordinary course of business. Pursuant to these arrangements, the Company indemnifies, holds harmless and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third party with respect to its technology. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The maximum potential amount of future payments the Company could be required to make under these arrangements is not determinable. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements. As a result, the Company believes the fair value of these agreements is not material.
The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by Delaware corporate law. The Company currently has directors’ and officers’ insurance.
Note 9. 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 data):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Numerator: | |||
| Net loss | $(117,255) | $(81,828) | $(41,567) |
| Denominator: | |||
| Weighted-average common shares outstanding, basic and diluted | 34,106,923 | 29,271,777 | 23,858,552 |
| Net loss per share, basic and diluted | $(3.44) | $(2.80) | $(1.74) |
Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all common stock equivalents outstanding would have been anti-dilutive. Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows:
| December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Stock options, issued and outstanding | 7,357,607 | 5,341,975 | 4,254,504 |
| Estimated shares issuable under the employee stock purchase plan | 31,645 | 17,655 | 6,542 |
| Restricted stock, issued and outstanding | 111,920 | 292,236 | 493,914 |
| Total | 7,501,172 | 5,651,866 | 4,754,960 |
Note 10. Selected Quarterly Financial Data (Unaudited)
The following tables provide the selected quarterly financial data for the years ended December 31, 2023 and 2022 (in thousands, except share and per share data):
| First | Second | Third | Fourth | |
|---|---|---|---|---|
| Quarter | Quarter | Quarter | Quarter | |
| Statements of Operations Data: | ||||
| Operating expenses: | ||||
| Research and development | $24,395 | $21,938 | $25,347 | $30,866 |
| General and administrative | 5,636 | 5,719 | 5,772 | $6,462 |
| Total operating expenses | 30,031 | 27,657 | 31,119 | 37,328 |
| Loss from operations | (30,031) | (27,657) | (31,119) | (37,328) |
| Interest and other income, net | 980 | 2,766 | 2,690 | $2,444 |
| Net loss | $(29,051) | $(24,891) | $(28,429) | $(34,884) |
| Net loss per share, basic and diluted | $(0.98) | $(0.70) | $(0.80) | $(0.98) |
| Weighted-average number of common shares used to compute basic and diluted net loss per common share | 29,586,468 | 35,348,293 | 35,653,988 | 35,754,165 |
| First | Second | Third | Fourth | |
|---|---|---|---|---|
| Quarter | Quarter | Quarter | Quarter | |
| Statements of Operations Data: | ||||
| Operating expenses: | ||||
| Research and development | $11,350 | $12,582 | $18,242 | $20,539 |
| General and administrative | 5,050 | 4,892 | 5,242 | 5,737 |
| Total operating expenses | 16,400 | 17,474 | 23,484 | 26,276 |
| Loss from operations | (16,400) | (17,474) | (23,484) | (26,276) |
| Interest and other income, net | 34 | 216 | 594 | 962 |
| Net loss | $(16,366) | $(17,258) | $(22,890) | $(25,314) |
| Net loss per share, basic and diluted | $(0.56) | $(0.59) | $(0.78) | $(0.86) |
| Weighted-average number of common shares used to compute basic and diluted net loss per common share | 29,126,088 | 29,196,398 | 29,319,042 | 29,441,596 |
Note 11. Subsequent Events
None.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.