−Removed: Market for Registrant’s Common Equity, Related Stock holder Matters and Issuer Purchases of Equity Securities.
+Added: Market for Registrant’s Common Equity, Related Stock holder Matters and Issuer Purchases of Equity Securities.
Market Information
−Removed: Our common stock has been publicly traded on The Nasdaq Global Select Market under the symbol “SPRO”
−Removed: since the initial public offering of our common stock on November 2, 2017.
+Added: Our common stock has been publicly traded on the Nasdaq Global Select Market under the symbol “SPRO” since the initial public offering of our common stock on November 2, 2017.
Prior to that time, there was no public market for our common stock.
7 unchanged sentences
Purchases of Equity Securities by the Issuer
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes appearing elsewhere in this Annual Report on Form 10-K.
−Removed: Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties.
−Removed: As a result of many factors, including those factors set forth in the “Risk Factors”
−Removed: section of this Annual Report on Form 10-K, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.
−Removed: We are a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for bacterial infections, including MDR bacterial infections, and rare diseases.
−Removed: Our lead product candidate, SPR720, is an oral antimicrobial agent in development for the treatment of NTM pulmonary disease, a rare orphan disease, where treatment failure is common, and no approved therapies exist.
−Removed: We believe that SPR720, if successfully developed and approved, has the potential to be the first approved oral agent for NTM pulmonary infection.
−Removed: Our partnership-directed programs consist of tebipenem HBr and SPR206, which through our business development efforts, each have partnership relationships supporting their ongoing development.
−Removed: Tebipenem HBr is designed to be the first broad-spectrum oral carbapenem-class antibiotic for use to treat certain bacterial infections that cause cUTIs, including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options.
−Removed: SPR206 is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections in the hospital setting.
−Removed: We believe that our novel product candidates, if successfully developed and approved, would have meaningful patient impacts and significant commercial applications for the treatment of bacterial infections, including MDR infections, in both the community and hospital settings.
−Removed: Since our inception in 2013, we have focused substantially all of our efforts and financial resources on organizing and staffing our company, business planning, raising capital, acquiring and developing product and technology rights, building our intellectual property portfolio and conducting research and development activities for our product candidates.
−Removed: We do not have any products approved for sale and have not generated any revenue from product sales.
−Removed: We have experienced net losses and significant cash outflows from cash used in operating activities since our inception.
−Removed: Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates.
−Removed: As of December 31, 2022, we had an accumulated deficit of $413.9 million, and cash and cash equivalents of $109.1 million.
−Removed: We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.
−Removed: We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the issuance of the financial statements included in this report.
−Removed: Based on our current operating plans, we believe that our cash runway will be sufficient to fund us beyond 2024.
−Removed: During this period, our strategic refocusing prioritizes advancing SPR720 and SPR206 to key Phase 2 milestones.
−Removed: Beyond this point we will need additional funding, which primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations, additional grant funding and/or reducing cash expenditures.
−Removed: If we are not able to secure adequate additional funding, we plan to make reductions in spending.
−Removed: In that event, we may have to delay, scale back, or eliminate some or all of our planned clinical trials and research stage programs.
−Removed: We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates.
−Removed: If we obtain regulatory approval for any of our product candidates and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing and distribution.
−Removed: Further, we expect to incur additional costs associated with our continued operation as a public company.
−Removed: As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.
−Removed: Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, government funding arrangements, collaborations, strategic alliances and marketing, distribution or licensing arrangements.
−Removed: We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all.
−Removed: If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates.
−Removed: Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability.
−Removed: Even if we are able to generate product sales, we may not become profitable.
−Removed: If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
−Removed: Components of Our Results of Operations
−Removed: Sales Revenue
−Removed: To date, we have not generated any revenue from product sales.
−Removed: If our development efforts for our product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales.
−Removed: We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of our product candidates.
−Removed: We may never succeed in obtaining regulatory approval for any of our product candidates.
−Removed: Grant Revenue
−Removed: We expect that a portion of our revenue for the next few years will continue to be derived from payments under our government awards that we have currently entered into and that we may enter into in the future.
−Removed: Collaboration Revenue
−Removed: Collaboration revenue relates to our agreements with Everest, Pfizer and GSK.
−Removed: Operating Expenses
−Removed: Research and Development Expenses
−Removed: Research and development expenses consist primarily of costs incurred for our research activities, including our drug discovery efforts, and the development of our product candidates, which include:
−Removed: employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in research and development functions;
−Removed: expenses incurred in connection with the preclinical and clinical development of our product candidates, including under agreements with contract research organizations (“CROs”);
−Removed: costs incurred in connection with our government awards;
−Removed: the cost of consultants and contract manufacturing organizations (“CMOs”) that manufacture drug products for use in our preclinical studies and clinical trials;
−Removed: facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and supplies;
−Removed: payments made under third-party licensing agreements.
−Removed: We have recorded research and development expenses conducted by our Australian subsidiary net of a 43.5% research and development tax incentive we expect to receive for qualified expenses from the Australian government.
−Removed: In June 2019, we entered into a collaboration with Gates MRI to develop SPR720 for the treatment of lung infections caused by Mtb.
−Removed: In furtherance of the Gates MRI’s charitable purposes, we also granted the Gates MRI a no cost, exclusive license to develop, manufacture and commercialize SPR720 for the treatment of TB in low- and middle- income countries.
−Removed: Gates MRI will conduct and fund preclinical and clinical studies for the development of SPR720 against TB and fund certain agreed upon collaborative research activities performed by us.
−Removed: Due to our assessment that we do not have a vendor/customer relationship with the Gates MRI, we recognize the funding received under the agreement as a reduction to the research and development expenses as the related expenses are incurred.
−Removed: We expense research and development costs as incurred.
−Removed: Nonrefundable advance payments we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses.
−Removed: The prepaid amounts are expensed as the related goods are delivered or the services are performed.
−Removed: Our direct research and development expenses are tracked on a program-by-program basis and consist primarily of external costs, such as fees paid to consultants, contractors, CMOs and CROs in connection with our preclinical and clinical development activities.
−Removed: License fees and other costs incurred after a product candidate has been designated and that are directly related to the
−Removed: product candidate are included in direct research and development expenses for that program.
−Removed: License fees and other costs incurred prior to designating a product candidate are included in early stage research programs.
−Removed: We do not allocate employee costs, costs associated with our preclinical programs or facility expenses, including depreciation or other indirect costs, to specific product development programs because these costs are deployed across multiple product development programs and, as such, are not separately classified.
−Removed: Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
−Removed: At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates.
−Removed: The successful development and commercialization of our product candidates is highly uncertain.
−Removed: This is due to the numerous risks and uncertainties, including the following:
−Removed: successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority, including on account of the disruptive impacts of the COVID-19 pandemic;
−Removed: receipt of marketing approvals from applicable regulatory authorities;
−Removed: establishment of arrangements with third-party manufacturers to obtain manufacturing supply;
−Removed: obtainment and maintenance of patent, trade secret protection and regulatory exclusivity, both in the United States and internationally, including our ability to maintain our license agreement with Meiji with respect to tebipenem HBr;
−Removed: protection of our rights in our intellectual property portfolio;
−Removed: launch of commercial sales our product candidates, if approved, whether alone or in collaboration with others;
−Removed: acceptance of our product candidates, if approved, by patients, the medical community and third-party payors;
−Removed: competition with other therapies;
−Removed: a continued acceptable safety profile of tebipenem HBr and our other product candidates, if approved.
−Removed: A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs and timing associated with the development of that product candidate.
−Removed: We may never succeed in obtaining regulatory approval for any of our product candidates.
−Removed: General and Administrative Expenses
−Removed: General and administrative expenses consist primarily of salaries and related costs, including share-based compensation, for personnel in executive, finance and administrative functions.
−Removed: General and administrative expenses also include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, investor and public relations, accounting and audit services.
−Removed: We also anticipate that we will continue to incur accounting, audit, legal, regulatory, compliance, infrastructure and director and officer insurance costs as well as investor and public relations expenses associated with our continued operation as a public company.
−Removed: Restructuring
−Removed: In light of our decision to suspend commercialization activities for tebipenem HBr and our strategic restructuring as announced in May 2022, our operating expenses were substantially reduced during the year ended December 31, 2022.
−Removed: We expect to continue to incur research and development and general and administrative expenses in 2023 to support activities under our subsequently announced GSK License Agreement that closed in November 2022.
−Removed: In connection with our restructuring, during the year ended December 31, 2022 we incurred approximately $11.6 million of costs in connection with the reduction in workforce related to severance pay and other restructuring costs.
−Removed: We incurred the majority of the costs associated with our restructuring during the second quarter of 2022.
−Removed: Other Income (Expense)
−Removed: Interest Income (Expense)
−Removed: Interest income (expense) consists of interest expense related to the sale of future royalties and interest earned on our cash equivalents, which are primarily invested in money market accounts, as well as interest earned on our investments in marketable securities that we held during the years ended December 31, 2022 and 2021.
−Removed: Other Income (Expense), Net
−Removed: Other income (expense), net, consists of insignificant amounts of miscellaneous income, as well as the loss on extinguishment of liability related to the sale of future royalties, the change in the fair value of our derivative liability, realized and unrealized gains and losses from foreign currency-denominated cash balances, vendor payables and receivables from the Australian research and development tax incentive.
−Removed: Since our inception, we have not recorded any income tax benefits for the net losses we have incurred in each year or for our earned research and development tax credits, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credits will not be realized.
−Removed: As of December 31, 2022, we had federal and state net operating loss carryforwards of $291.9 million and $282.9 million, respectively, which may be available to offset future income tax liabilities.
−Removed: The federal NOLs of $73.0 million will expire at various dates from 2033 to 2037 and approximately $218.9 million can be carried forward indefinitely.
−Removed: The state NOLs begin to expire in 2033 and will expire at various dates through 2039.
−Removed: In addition, as of December 31, 2022, we had foreign net operating loss carryforwards of $4.6 million, which may be available to offset future income tax liabilities and do not expire.
−Removed: As of December 31, 2022, we also had federal and state research and development tax credit carryforwards of $11.5 million and $2.8 million, respectively, which begin to expire in 2033 and 2028, respectively.
−Removed: We have recorded a full valuation allowance against our net deferred tax assets at each balance sheet date.
−Removed: Critical Accounting Policies and Significant Judgments and Estimates
−Removed: Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States (“GAAP”).
−Removed: The preparation of our consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures.
−Removed: We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
−Removed: We evaluate our estimates and assumptions on an ongoing basis.
−Removed: Our actual results may differ from these estimates under different assumptions or conditions.
−Removed: We believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
−Removed: Funding Received from Government Contracts and Collaborations
−Removed: Since our inception, we have been able to obtain partial funding for our research and development activities from government contracts, government tax incentives and collaboration arrangements.
−Removed: The classification within our statement of operations and comprehensive loss of the funding received under these arrangements is subject to management judgment based on the nature of the arrangements we enter into, the source of the funding and whether the funding is considered central to our business operations.
−Removed: Government Contracts
−Removed: We generate revenue from government contracts that reimburse us for certain allowable costs for funded projects.
−Removed: For contracts with government agencies, when we have concluded that we are the principal in conducting the research and development expenses and where the funding arrangement is considered central to our ongoing operations, we classify the recognized funding received as revenue.
−Removed: Revenue from government grants is recognized as the qualifying expenses related to the contracts are incurred, provided that there is reasonable assurance of recoverability.
−Removed: Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded as unbilled receivables, a component of prepaid expenses and other current assets, in the consolidated balance sheet.
−Removed: We recognize funding received from BARDA, the DoD and the NIAID of the NIH, as revenue, rather than as a reduction of research and development expenses, because we are the principal in conducting the research and development activities and these contracts are central to our ongoing operations.
−Removed: We recognize revenue only after the qualifying expenses related to the contracts have been incurred, we are reasonably assured that the expenses will be reimbursed and the revenue is collectible.
−Removed: We record revenue recognized upon incurring qualifying expenses in advance of billing as unbilled revenue, which is included in other receivables in our consolidated balance sheet.
−Removed: The related costs incurred by us are included in research and development expense in our consolidated statements of operations and comprehensive loss.
−Removed: Collaboration Agreements
−Removed: For collaboration agreements with a third party, to determine the appropriate statement of operations classification of the recognized funding, we first assess whether the collaboration arrangement is within the scope of the accounting guidance for collaboration arrangements.
−Removed: If it is, we evaluate the collaborative arrangement for proper classification in the statement of operations based on the nature of the underlying activity and we assess the payments to and from the collaborative partner.
−Removed: If the payments to and from the collaborative partner are not within the scope of other authoritative accounting guidance, we base the statement of operations classification for the payments received on a reasonable, rational analogy to authoritative accounting guidance, applied in a consistent manner.
−Removed: Conversely, if the collaboration arrangement is not within the scope of accounting guidance for collaboration arrangements, we assess whether the collaboration arrangement represents a vendor/customer relationship.
−Removed: If the collaborative arrangement does not represent a vendor/customer relationship, we then classify the funding payments received in the statement of operations and comprehensive loss as a reduction of the related expense that is incurred.
−Removed: Revenue Recognition - GSK License Agreement
−Removed: In determining the accounting treatment for the GSK License Agreement, we developed assumptions to determine the stand-alone selling price for each performance obligation in the contract.
−Removed: We developed the estimated standalone selling price for the license using a discounted cash flow model.
−Removed: To develop this model, we applied significant judgement in the determination of the significant assumptions relating to forecasted future revenues, development time lines, the discount rate, and probabilities of technical and regulatory success.
−Removed: We developed the estimated standalone selling price for the research and development services using a discounted cash flow model.
−Removed: The assumptions to develop the estimated standalone selling price for the related research and development services include estimates of costs to be incurred to fulfill its obligations associated with the performance of the research and development services, plus a reasonable margin.
−Removed: Accrued Research and Development Expenses
−Removed: As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses.
−Removed: This process involves reviewing open contracts and purchase orders, communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs.
−Removed: The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met;
−Removed: however, some require advance payments.
−Removed: We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time.
−Removed: We periodically confirm the accuracy of the estimates with the service providers and make adjustments if necessary.
−Removed: Examples of estimated accrued research and development expenses include fees paid to:
−Removed: vendors in connection with the preclinical development activities;
−Removed: CMOs in connection with the production of preclinical and clinical trial materials;
−Removed: CROs in connection with preclinical and clinical studies;
−Removed: investigative sites in connection with clinical trials.
−Removed: We base our expenses related to preclinical studies and clinical trials on our estimates of the services received and efforts expended pursuant to quotes and contracts with multiple research institutions and CROs that conduct and manage preclinical studies and clinical trials on our behalf.
−Removed: The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows.
−Removed: There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense.
−Removed: In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period.
−Removed: If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or prepaid expense accordingly.
−Removed: Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period.
−Removed: To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.
−Removed: Share-Based Compensation
−Removed: We issue stock-based awards to employees and directors in the form of stock options and restricted stock units.
−Removed: We measure and recognize compensation expense for our stock-based awards granted to our employees and directors based on the estimated grant date fair value in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification Topic 718 (“ASC 718”), Compensation—Stock Compensation.
−Removed: We determine the fair value of restricted stock units based on the fair value of our common stock.
−Removed: We measure all share-based options granted to employees and directors based on the fair value on the date of grant
−Removed: using the Black-Scholes option-pricing model, and we recognize compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award.
−Removed: Generally, we issue awards with only service-based vesting conditions and record the expense for these awards using the straight-line method.
−Removed: The Black-Scholes option-pricing model uses as inputs the fair value of our common stock and assumptions we make for the volatility of our common stock, the expected term of our common stock options and performance-based awards, the risk-free interest rate for a period that approximates the expected term of our common stock options and performance-based awards, and our expected dividend yield.
−Removed: In 2022, the Company granted certain awards with performance-based criteria.
−Removed: Certain performance-based awards are recorded as an accrued liability on the Company's condensed consolidated balance sheet and accrued over time as achievement of performance metrics become probable.
−Removed: Restructuring
−Removed: We made estimates and judgments regarding the amount and timing of our restructuring expense and liability, including one-time termination benefits and other exit costs accounted for upon the announcement of our restructuring in May 2022.
−Removed: Restructuring charges are reflected in our consolidated statements of income.
−Removed: Results of Operations
−Removed: Comparison of the Years Ended December 31, 2022 and 2021
−Removed: The following table summarizes our results of operations for the years ended December 31, 2022 and 2021:
−Removed: Year Ended December 31,
−Removed: Grant revenue
−Removed: Collaboration revenue
−Removed: Total revenues
−Removed: Operating expenses:
−Removed: Research and development
−Removed: General and administrative
−Removed: Restructuring
−Removed: Total operating expenses
−Removed: Loss from operations
−Removed: Other income (expense):
−Removed: Interest income
−Removed: Other income (expense), net
−Removed: Interest expense related to the sale of future royalties
−Removed: Loss on extinguishment of liability related to the sale of future royalties
−Removed: Change in fair value of derivative liability
−Removed: Total other income (expense), net
−Removed: Grant Revenue
−Removed: Year Ended December 31,
−Removed: BARDA Contract (Tebipenem HBr)
−Removed: NIAID Contract (SPR206)
−Removed: DoD Agreement (SPR206)
−Removed: Total revenue
−Removed: Grant revenue recognized during 2022 and 2021 consisted of the reimbursement of qualifying expenses incurred in connection with our various government awards.
−Removed: The decrease in revenue during 2022 was primarily due to a decrease of $7.7 million in funding under our BARDA contract for tebipenem HBr, a decrease of $3.5 million in funding under our DoD agreement relating to SPR206, partially offset by an increase of $0.9 million in qualified expenses incurred under our NIAID award relating to SPR206.
−Removed: Collaboration Revenue
−Removed: During the year ended December 31, 2022 we recognized collaboration revenue of $46.1 million related to our agreement with GSK, $1.8 million related to our agreement with Pfizer, and $0.7 million related to milestones earned under our agreement with Everest.
−Removed: During the year ended December 31, 2021 we recognized collaboration revenue of $1.8 million related to our agreement with Pfizer consisting primarily of the delivery of the license for SPR206 in ex-U.S.
−Removed: and ex-Asia territories and $1.3 million related to milestones earned under our agreement with Everest.
−Removed: Research and Development Expenses
−Removed: Year Ended December 31,
−Removed: Direct research and development expenses by program:
−Removed: Tebipenem HBr
−Removed: Unallocated expenses:
−Removed: Personnel related (including share-based compensation)
−Removed: Facility related and other
−Removed: Total research and development expenses
−Removed: Direct costs related to our SPR720 program increased by $0.6 million during 2022 compared to 2021, due to increased clinical and preclinical activity during the period related to our Phase 2a clinical trial of SPR720, which we initiated in the fourth quarter of 2022.
−Removed: We expect to continue to incur direct costs related to SPR720 as we progress preclinical and clinical activities.
−Removed: During the year ended December 31, 2022, we did not record a reduction to direct costs related to our SPR720 program related to activities funded by Gates MRI.
−Removed: During the year ended December 31, 2021, direct costs related to our SPR720 program reflected a $1.5 million reduction to expense related to activities funded by Gates MRI.
−Removed: Direct costs related to our tebipenem HBr program decreased by $11.8 million during 2022 compared to 2021 primarily due to the reduced program activity as a result of our strategic restructuring announced in May 2022 and further described in Note 10 –
−Removed: Restructuring to the Financial Statements.
−Removed: During the year ended December 31, 2022, direct costs related to tebipenem HBr included $6.6 million paid to Meiji, as a percentage of certain amounts received from any sublicensees, out of the $7.5 million we are obligated to pay under the Meiji License.
−Removed: Direct costs related to our SPR206 program decreased by $1.8 million during the year ended December 31, 2022, primarily due to decreased clinical activity during the period.
−Removed: We expect to continue to incur direct costs related to SPR206 as we progress preclinical and clinical activities.
−Removed: The decrease in personnel-related costs of $3.7 million was primarily due to decreased research and development headcount costs related to our strategic restructuring.
−Removed: Personnel-related costs for the years ended December 31, 2022 and 2021 included share-based compensation expenses of $3.7 million and $4.2 million, respectively.
−Removed: Facility-related and other costs primarily reflect costs related to supporting our research and development staff.
−Removed: General and Administrative Expenses
−Removed: Year Ended December 31,
−Removed: Personnel related (including share-based compensation)
−Removed: Professional and consultant fees
−Removed: Facility related and other
−Removed: Total general and administrative expenses
−Removed: The decrease in personnel-related costs of $1.8 million was primarily a result of decreased headcount costs in our commercial and general and administrative functions as a result of our strategic restructuring.
−Removed: Personnel-related costs for the years ended December 31, 2022 and 2021 included share-based compensation expense of $5.4 million and $5.3 million, respectively.
−Removed: The decrease in professional and consultant fees of $3.8 million was primarily due to decreased commercial operation expenses related to our strategic restructuring, partially offset by legal expenses.
−Removed: Facility-related and other costs primarily reflect costs related to supporting our general and administrative staff.
−Removed: Restructuring
−Removed: During the year ended December 31, 2022, we incurred restructuring expenses of $11.6 million related to our strategic restructuring that we announced in May 2022.
−Removed: Restructuring expenses for the period were primarily comprised of $8.6 million of severance and other employee costs and $3.0 million of discontinuation costs such as contract termination fees and lease impairment expenses.
−Removed: For further information, refer to Note 10 –
−Removed: Restructuring to the Financial Statements.
−Removed: Other Income (Expense), Net
−Removed: Other income (expense), net was $(4.2) million during 2022, compared to $(1.8) million during 2021.
−Removed: Total other expense for the year ended December 31, 2022 included $2.6 million in interest expense related to the sale of future royalties, $3.6 million in loss on extinguishment of liability related to the sale of future royalties and net immaterial changes primarily due to fluctuations in unrealized foreign currency gains, offset by a $0.9 million net change in derivative liability and $1.1 million in interest income.
−Removed: Liquidity and Capital Resources
−Removed: Since our inception, we have incurred significant operating losses.
−Removed: We have recognized revenue to date from funding arrangements with the DoD, NIAID, CARB-X and BARDA and our license agreements with Everest, Pfizer and GSK.
−Removed: We have not yet commercialized any of our product candidates and we may not generate revenue from sales of any product candidates.
−Removed: To date, we have funded our operations with payments received under license and collaboration agreements and funding from government contracts, and mostly from the proceeds of multiple common stock offerings.
−Removed: As of December 31, 2022, we had cash and cash equivalents of $109.1 million.
−Removed: Below is a summary of some of the items impacting our liquidity and capital resources in 2022:
−Removed: On May 3, 2022, we implemented a strategic restructuring initiative and corresponding reduction in workforce.
−Removed: The restructuring initiative and corresponding reduction in workforce was designed to reduce costs and reallocate resources towards the Company’s clinical development programs for SPR720 and SPR206, while maintaining key personnel needed to help preserve the value of the tebipenem HBr program.
−Removed: On June 7, 2022, we entered into the Termination Agreement with HCR and HCR Collateral Management, LLC, as collateral agent for HCR under the previously disclosed Revenue Interest Agreement, pursuant to which the parties mutually terminated the HCR Agreements, and certain other related ancillary agreements, arrangements or understandings under or contemplated by the HCR Agreements.
−Removed: We were released from all of our obligations and the rights to any future revenues and collateral reverted back to us in return for a cash payment of $54.5 million.
−Removed: We recognized a loss on the extinguishment of $3.6 million, as reported on our condensed consolidated statement of operations and comprehensive loss.
−Removed: In September 2022, we entered into the GSK License Agreement with respect to tebipenem HBr.
−Removed: Pursuant to the GSK License Agreement, we received a $66.0 million upfront payment from GSK and are eligible to receive up to $525.0 million in development, sales, and commercial milestones payments, as well as low single-digit to low double-digit tiered royalties on net product sales.
−Removed: In exchange, GSK received an exclusive license to develop and commercialize tebipenem pivoxil and tebipenem pivoxil HBr in all territories, except Japan, and certain other Asian countries, territories which will be retained by our partner Meiji.
−Removed: In connection with the GSK License Agreement, an affiliate of GSK purchased 7,450,000 shares of the Company’s common stock at a purchase price of approximately $1.20805 per share for an aggregate purchase price of $9.0 million.
−Removed: During the year ended December 31, 2022, we sold 5,963,294 shares of our common stock under the Sales Agreement at an average price of approximately $2.46 per share for aggregate gross proceeds of approximately $14.7 million prior to deducting sales commissions.
−Removed: In addition, on January 19, 2022, we announced BARDA added and exercised a new option on the contract originally awarded to us in 2018.
−Removed: The new option increases the total amount of committed funding by $12.9 million to $46.9 million, increasing the total potential contract value to $59.7 million.
−Removed: As previously announced, the DTRA is providing up to approximately $10.0 million, in addition to the total potential award from BARDA, to cover the cost of the nonclinical biodefense aspects of the collaboration program for tebipenem HBr.
−Removed: In September 2022, remaining funding from the $12.9 million option was reprogrammed to support clinical trials for patients with cUTIs, including acute pyelonephritis.
−Removed: The period of performance for this new option extends through December 31, 2025 and does not change the total amount of committed funding or potential contract value.
−Removed: The following table summarizes our sources and uses of cash for the years ended December 31, 2022 and 2021:
−Removed: Year Ended December 31,
−Removed: Cash used in operating activities
−Removed: Cash provided by investing activities
−Removed: Cash provided by (used in) financing activities
−Removed: Net increase (decrease) in cash and cash equivalents
−Removed: Operating Activities
−Removed: Net cash used in operating activities for the year ended December 31, 2022 was $7.7 million, primarily resulting from our net loss of $46.4 million, adjusted for net non-cash items of $16.6 million (primarily stock-based compensation, interest expense associated with the sale of future royalties, loss on extinguishment of liability related to the sale of future royalties, change in the value of derivative liabilities and depreciation and amortization expense).
−Removed: Net cash provided by changes in our operating assets and liabilities was $22.1 million and consisted primarily of a $21.9 million net increase in deferred revenue, a decrease of $5.9 million in accrued expenses and accounts payable, a $5.2 million decrease in prepaid expenses and other current assets and a $1.5 million net decrease in receivables related to our tax incentive receivables and government awards.
−Removed: Net cash used in operating activities for the year ended December 31, 2021 was $64.3 million, primarily resulting from our net loss of $89.8 million, adjusted for net non-cash items of $12.5 million (primarily stock-based compensation, interest expense associated with the sale of future royalties and depreciation and amortization expense).
−Removed: Net cash provided by changes in our operating assets and liabilities was $12.9 million and consisted primarily of a $10.6 million net increase in deferred revenue, an increase of $2.1 million in accrued expenses and accounts payable, a $2.8 million increase in prepaid expenses and other current assets and a $3.8 million net decrease in receivables related to our tax incentive receivables and government awards and a $0.3 million net increase in other assets.
−Removed: Changes in accounts payable, accrued expenses and other current liabilities and prepaid expenses and other current assets in all periods were generally due to the advancement of our development programs, the timing of vendor invoicing and payments and write-offs during the second quarter of 2022 related to our strategic restructuring.
−Removed: Changes in deferred revenue are primarily related to our license agreement with GSK.
−Removed: Investing Activities
−Removed: Net cash provided by investing activities for the year ended December 31, 2022 was $33.8 million, primarily related to the maturities of marketable securities of $60.8 million, offset by purchases of marketable securities of $27.0 million.
−Removed: Net cash provided by investing activities for the year ended December 31, 2021 was $7.7 million, primarily related to the maturities of marketable securities of $51.5 million, offset by purchases of marketable securities of $43.9 million.
−Removed: Financing Activities
−Removed: Net cash used in financing activities for the year ended December 31, 2022 was $29.6 million, consisting primarily of the $54.5 million repayment of our liability related to the sales of future royalties, partially offset by net proceeds of $14.2 million from the sale of common stock under our “at-the-market”
−Removed: offering program Sales Agreement, proceeds of $9.0 million related to our GSK SPA, and proceeds of $0.4 million from the exercise of employee stock options.
−Removed: Net cash provided by financing activities for the year ended December 31, 2021 was $84.1 million, consisting primarily of $47.3 million in proceeds from the sale of future royalties, net of transaction costs, $27.5 million in proceeds related to the Pfizer Purchase Agreement, net proceeds of $7.8 million from the sale of common stock under our “at-the-market”
−Removed: offering program Sales Agreement and proceeds of $1.5 million from the exercise of employee stock options, offset by the payment of offering expenses of approximately $0.2 million.
−Removed: Funding Requirements
−Removed: We expect our expenses to increase in connection with our ongoing activities, particularly as we advance our clinical programs and prepare for possible commercialization of one or more of our product candidates.
−Removed: In addition, we expect to incur additional costs associated with our continued operation as a public company.
−Removed: The timing and amount of our operating expenditures will depend largely on:
−Removed: the timing and costs of our ongoing and planned clinical trials;
−Removed: the initiation, progress, timing, costs and results of preclinical studies and clinical trials of our product candidates and potential new product candidates;
−Removed: the amount of funding that we receive under government contracts that we have applied for;
−Removed: the number and characteristics of product candidates that we pursue;
−Removed: the outcome, timing and costs of seeking regulatory approvals;
−Removed: the costs of commercialization activities for our product candidates if we receive marketing approval, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;
−Removed: the terms and timing of any future collaborations, licensing or other arrangements that we may establish;
−Removed: the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights, including milestone and royalty payments and patent prosecution fees that we are obligated to pay pursuant to our license agreements;
−Removed: the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property related claims;
−Removed: the costs of operating as a public company;
−Removed: the extent to which we in-license or acquire other products and technologies.
−Removed: As of December 31, 2022, we had cash and cash equivalents of $109.1 million.
−Removed: In accordance with ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we are required to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern from the issuance date of our financial statements.
−Removed: We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the issuance of the financial statements included in this report.
−Removed: Based on our current operating plans, we believe that our cash runway will be sufficient to fund us beyond 2024.
−Removed: Beyond this point we will need additional funding, which primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations, additional grant funding and/or reducing cash expenditures.
−Removed: If we are not able to secure adequate additional funding, we plan to make reductions in spending.
−Removed: In that event, we may have to delay, scale back, or eliminate some or all of our planned clinical trials and research stage programs.
−Removed: We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.
−Removed: Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements.
−Removed: Our future funding requirements will depend on and could increase significantly as a result of many factors, including those listed above.
−Removed: Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, government funding, collaborations, strategic alliances and marketing, distribution or licensing arrangements.
−Removed: To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders’
−Removed: ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders.
−Removed: Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends.
−Removed: If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.
−Removed: The COVID-19 pandemic has resulted in ongoing volatility in financial markets.
−Removed: If our access to capital is restricted or associated borrowing costs increase as a result of developments in financial markets, including relating to the COVID-19 pandemic, our operations and financial condition could be adversely impacted.
−Removed: If we are unable to raise additional funds through equity or debt
−Removed: financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
−Removed: Contractual Obligations and Commitments
−Removed: The following table summarizes our contractual obligations as of December 31, 2022 and the effects that such obligations are expected to have on our liquidity and cash flows in future periods:
−Removed: Payments Due by Period
−Removed: Less Than 1 Year
−Removed: More than 5 Years
−Removed: (in thousands)
−Removed: Operating lease commitments (1)
−Removed: (1) Reflects payments due for our lease of office space under an operating lease agreement that expires in 2027.
−Removed: As further described below, under various licensing and related agreements with third parties, we have agreed to make milestone payments and pay royalties to third parties.
−Removed: We have not included any contingent payment obligations, such as milestones or royalties, in the table above as the amount, timing and likelihood of such payments are not known.
−Removed: Under our license agreement with Meiji, we are obligated (i) to make future milestone payments of up to $1.0 million upon the achievement of specified clinical and regulatory milestones for tebipenem HBr, (ii) to pay royalties, on a product-by-product and country-by-country basis, of a low single-digit percentage based on net sales of products licensed under the agreement and (iii) to pay to Meiji a low double-digit percentage of any sublicense fees received by us up to $7.5 million, of which we paid $6.6 million in the fourth quarter of 2022.
−Removed: Under an agreement we entered into with PBB, we are obligated to make milestone payments of up to $5.8 million upon the achievement of specified clinical milestones and a payment of £5.0 million ($6.0 million as of December 31, 2022) upon the achievement of a specified commercial milestone for SPR206.
−Removed: In addition, we have agreed to pay to PBB royalties, on a product-by-product and country-by-country basis, of a low single-digit percentage based on net sales of products licensed under the agreement.
−Removed: Under our agreement with Vertex, we are obligated to make future milestone payments of up to $80.2 million upon the achievement of specified clinical, regulatory and commercial milestones related to SPR720 and to pay to Vertex tiered royalties, on a product-by-product and country-by-country basis, of a mid single-digit to low double-digit percentage based on net sales of products licensed under the agreement.
−Removed: We enter into contracts in the normal course of business with CROs, CMOs and other third parties for clinical trials, preclinical research studies and testing, manufacturing and other services.
−Removed: These contracts are cancelable by us upon prior notice.
−Removed: Payments due upon cancellation consist only of payments for services provided or expenses incurred, including non-cancellable obligations of our service providers, up to the date of cancellation.
−Removed: These payments are not included in the table of contractual obligations and commitments above.
−Removed: Recently Adopted Accounting Pronouncements
−Removed: Please refer to Note 2 to our consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data,”
−Removed: of this Annual Report on Form 10-K for a description of recent accounting pronouncements applicable to our business.
−Removed: Quantitative and Qualitati ve Disclosures About Market Risk.
−Removed: As of December 31, 2022, we had cash and cash equivalents of $109.1 million, consisting of cash and money market accounts.
−Removed: The primary objectives of our investment activities are to preserve principal, provide liquidity and maximize income without significantly increasing risk.
−Removed: Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of United States interest rates.
−Removed: We did not have any assets classified as marketable securities as of December 31, 2022.
−Removed: As we incur research expenses in foreign countries, we face exposure to movements in foreign currency exchange rates, primarily the Euro, British Pound and Australian dollar against the United States dollar.
−Removed: Historically, foreign currency fluctuations have not had a material impact on our consolidated financial statements.
−Removed: Financial Statement s and Supplementary Data.
−Removed: INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Report of Independent Registered Public Accounting Firm (PCAOB ID 238 )
−Removed: Consolidated Balance Sheets
−Removed: Consolidated Statements of Operations and Comprehensive Loss
−Removed: Consolidated Statements of Convertible Preferred Shares and Stockholders’
−Removed: Consolidated Statements of Cash Flows
−Removed: Notes to Consolidated Financial Statements
−Removed: Report of Independent Regis tered Public Accounting Firm
−Removed: To the Board of Directors and Stockholders of Spero Therapeutics, Inc.
−Removed: Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets of Spero Therapeutics, Inc.
−Removed: and its subsidiaries (the “Company”) as of December 31, 2022 and 2021, and the related consolidated statements of operations and comprehensive loss, of convertible preferred shares and stockholders’
−Removed: equity and of cash flows for the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
−Removed: Basis for Opinion
−Removed: These consolidated financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
−Removed: As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.
−Removed: Accordingly, we express no such opinion.
−Removed: Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical Audit Matters
−Removed: The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: Revenue Recognition - GSK License Agreement Determination of Standalone Selling Price of the License
−Removed: As described in Notes 7 and 14 to the consolidated financial statements, on November 7, 2022, the Company closed the GSK plc (GSK) license agreement under which the Company received an upfront payment of $66.0 million in exchange for granting GSK an exclusive royalty-bearing license to develop, manufacture and commercialize tebipenem pivoxil and tebipenem HBr.
−Removed: The Company will be responsible for the execution and costs of the follow-up Phase 3 clinical trial of tebipenem HBr and for providing and paying for the clinical supply of tebipenem HBr.
−Removed: Concurrently with the execution of the GSK license agreement, the Company entered into a stock purchase agreement with Glaxo Group Limited (GGL), an affiliate of GSK, pursuant to which GGL purchased shares of the Company’s common stock for an aggregate purchase price of $9.0 million.
−Removed: The fair market value of the Company’s common stock issued under the stock purchase agreement was $10.3 million.
−Removed: The Company identified two performance obligations, related to the license and to research and development services.
−Removed: The total transaction price is $64.7 million, which includes the initial payment of $66.0 million and the discount of $1.3 million related to the stock purchase agreement.
−Removed: The total transaction price was allocated to the performance obligations under the agreement in proportion to the standalone selling price of each obligation.
−Removed: Management developed the estimated standalone selling price for the license using a discounted cash flow model.
−Removed: In developing this estimate, management applied significant judgment in the determination of the significant assumptions relating to forecasted future cash flows, the discount
−Removed: rate, and the probability of success.
−Removed: Of the total transaction price, $45.7 million was allocated to the license performance obligation, which was fully satisfied and recognized as revenue upon delivery of the license, and the additional $19.0 million was allocated to the research and development services obligation and is being recognized over time as the services are delivered.
−Removed: The principal considerations for our determination that performing procedures relating to revenue recognition and the determination of standalone selling price for the license is a critical audit matter are (i) the significant judgment by management when developing the estimate of standalone selling price for the license;
−Removed: (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating management’s significant assumptions related to forecasted future cash flows, the discount rate, and the probability of success;
−Removed: and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.
−Removed: Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.
−Removed: These procedures included, among others (i) reading the contractual terms of the license agreement;
−Removed: (ii) testing management’s process for developing the estimate of standalone selling price for the license;
−Removed: (iii) evaluating the appropriateness of the discounted cash flow model;
−Removed: and (iv) evaluating the reasonableness of the significant assumptions related to forecasted future cash flows, the discount rate, and the probability of success.
−Removed: Evaluating management’s assumptions related to forecasted future cash flows and the probability of success involved evaluating whether the assumptions used were reasonable considering (i) the consistency with data from internal and external sources including market and industry data and (ii) whether the assumptions were consistent with evidence obtained in other areas of the audit.
−Removed: Professionals with specialized skill and knowledge were used to assist in evaluating (i) the appropriateness of the discounted cash flow model and (ii) the reasonableness of the discount rate.
−Removed: /s/ PricewaterhouseCoopers LLP
−Removed: Boston, Massachusetts
−Removed: March 30, 2023
−Removed: We have served as the Company's auditor since 2016.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: CONSOLIDATED B ALANCE SHEETS
−Removed: (In thousands, except unit, share and per share amounts)
−Removed: Current assets:
−Removed: Cash and cash equivalents
−Removed: Marketable securities
−Removed: Other receivables
−Removed: Prepaid expenses and other current assets
−Removed: Total current assets
−Removed: Property and equipment, net
−Removed: Operating lease right-of-use assets
−Removed: Liabilities and Stockholders' Equity
−Removed: Current liabilities:
−Removed: Accounts payable
−Removed: Accrued expenses and other current liabilities
−Removed: Operating lease liabilities
−Removed: Deferred revenue, current
−Removed: Total current liabilities
−Removed: Liability related to the sale of future royalties
−Removed: Non-current operating lease liabilities
−Removed: Deferred revenue, non-current
−Removed: Derivative liability
−Removed: Other long-term liabilities
−Removed: Total liabilities
−Removed: Commitments and contingencies (Note 12)
−Removed: Stockholders' equity:
−Removed: Preferred stock, $ 0.001 par value;
−Removed: 10,000,000 shares authorized, no shares issued and outstanding as of December 31, 2022 and 3,218,152 shares issued and outstanding as of December 31, 2021
−Removed: Common stock, $ 0.001 par value;
−Removed: 120,000,000 shares authorized as of December 31, 2022 and December 31, 2021;
−Removed: 52,456,195 shares issued and outstanding as of December 31, 2022 and 32,393,738 shares issued and outstanding as of December 31, 2021
−Removed: Additional paid-in capital
−Removed: Accumulated deficit
−Removed: Accumulated other comprehensive gain (loss)
−Removed: Total stockholders' equity
−Removed: Total liabilities and stockholders' equity
−Removed: The accompanying notes are an integral part of these consolidated financial statements.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: CONSOLIDATED STATEMENTS OF OPER ATIONS AND COMPREHENSIVE LOSS
−Removed: (In thousands, except share and per share data)
−Removed: Year Ended December 31,
−Removed: Grant revenue
−Removed: Collaboration revenue
−Removed: Total revenues
−Removed: Operating expenses:
−Removed: Research and development
−Removed: General and administrative
−Removed: Restructuring
−Removed: Total operating expenses
−Removed: Loss from operations
−Removed: Other income (expense):
−Removed: Interest income
−Removed: Other income (expense), net
−Removed: Interest expense related to the sale of future royalties
−Removed: Loss on extinguishment of liability related to the sale of future royalties
−Removed: Change in fair value of derivative liability
−Removed: Total other income (expense), net
−Removed: Net loss per share attributable to common stockholders, basic and diluted
−Removed: Weighted average common shares outstanding, basic and diluted:
−Removed: Comprehensive loss:
−Removed: Other comprehensive gain (loss):
−Removed: Unrealized gain on marketable securities
−Removed: Net unrealized gains (losses) on securities
−Removed: Total comprehensive loss
−Removed: The accompanying notes are an integral part of these consolidated financial statements.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED SHARES AND
−Removed: STOCKHOLDERS’
−Removed: (In thousands, except unit and share amounts)
−Removed: Series A, B, C and D
−Removed: Convertible Preferred Stock
−Removed: Other Comprehensive
−Removed: Stockholders'
−Removed: Income (Loss)
−Removed: Balances at December 31, 2020
−Removed: Issuance of common stock upon the exercise of stock options
−Removed: Issuance of common stock, net of issuance costs
−Removed: Issuance of common stock under Pfizer Purchase Agreement, net of premium of $ 12.5 million and net of financing costs of $ 0.2 million
−Removed: Conversion of convertible preferred stock to common stock
−Removed: Share-based compensation expense
−Removed: Unrealized gain on available-for-sale securities
−Removed: Balances at December 31, 2021
−Removed: Issuance of common stock upon the exercise of stock options
−Removed: Issuance of common stock upon the vesting of RSUs
−Removed: Issuance of common stock, net of issuance costs
−Removed: Issuance of common stock under GSK Share Purchase Agreement, net of discount of $ 1.3 million
−Removed: Conversion of convertible preferred stock to common stock
−Removed: Share-based compensation expense
−Removed: Unrealized gain on available-for-sale securities
−Removed: Balances at December 31, 2022
−Removed: The accompanying notes are an integral part of these consolidated financial statements.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: CONSOLIDATED STATEM ENTS OF CASH FLOWS
−Removed: (In thousands)
−Removed: Year Ended December 31,
−Removed: Cash flows from operating activities:
−Removed: Adjustments to reconcile net loss to net cash used in operating activities:
−Removed: Depreciation and amortization
−Removed: Non-cash lease cost
−Removed: Impairment of assets
−Removed: Share-based compensation
−Removed: Unrealized foreign currency transaction loss
−Removed: Accretion of premium (discount) on marketable securities
−Removed: Change in fair value of derivative liabilities
−Removed: Non-cash interest expense associated with the sale of future royalties
−Removed: Loss on extinguishment of liability related to the sale of future royalties
−Removed: Changes in operating assets and liabilities:
−Removed: Other receivables
−Removed: Prepaid expenses and other current assets
−Removed: Tax incentive receivables
−Removed: Accounts payable
−Removed: Accrued expenses and other current liabilities
−Removed: Deferred revenue, current and non-current
−Removed: Other long-term liabilities
−Removed: Operating lease liabilities
−Removed: Net cash used in operating activities
−Removed: Cash flows from investing activities:
−Removed: Purchases of marketable securities
−Removed: Proceeds from maturities of marketable securities
−Removed: Net cash provided by investing activities
−Removed: Cash flows from financing activities:
−Removed: Repayment of liability related to the sale of future royalties
−Removed: Proceeds from the issuance of common stock, net of issuance costs
−Removed: Proceeds from the issuance of common stock related to the GSK Share Purchase Agreement
−Removed: Proceeds from the issuance of common stock related to the Pfizer Purchase Agreement
−Removed: Proceeds from sale of future royalties, net
−Removed: Transaction costs from sale of future royalties
−Removed: Royalty payments
−Removed: Payment of offering costs
−Removed: Proceeds from stock option exercises
−Removed: Net cash (used in) provided by financing activities
−Removed: Net increase (decrease) in cash and cash equivalents
−Removed: Cash and cash equivalents at beginning of period
−Removed: Cash and cash equivalents at end of period
−Removed: The accompanying notes are an integral part of these consolidated financial statements.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Nature of the Business and Basis of Presentation
−Removed: Spero Therapeutics, Inc., together with its consolidated subsidiaries (the “Company”
−Removed: or “Spero”), is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments for bacterial infections, including multi-drug resistant (“MDR”) bacterial infections, and rare diseases.
−Removed: The Company's lead product candidate, SPR720, is an oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (“NTM”) pulmonary disease, a rare orphan disease.
−Removed: The Company's partnership-directed programs consist of SPR206 and tebipenem HBr.
−Removed: SPR206 is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections in the hospital setting.
−Removed: Tebipenem HBr is designed to be the first broad-spectrum oral carbapenem-class antibiotic for use to treat certain bacterial infections that cause complicated urinary tract infections (“cUTIs”) including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options.
−Removed: The Company was formed as Spero Therapeutics, LLC in December 2013 under the laws of the State of Delaware .
−Removed: On June 30, 2017 , through a series of transactions, Spero Therapeutics, LLC merged with and into Spero Therapeutics, Inc.
−Removed: (formerly known as Spero OpCo, Inc.), a Delaware corporation.
−Removed: The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, risks of failure or unsatisfactory results of nonclinical studies and clinical trials, the need to obtain marketing approval for its product candidates, the need to successfully commercialize and gain market acceptance of its product candidates and the ability to secure additional capital to fund operations.
−Removed: The Company’s product candidates will require additional preclinical and clinical testing and regulatory approval prior to commercialization.
−Removed: These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities.
−Removed: Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
−Removed: The accompanying consolidated financial statements of the Company have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of the Company and its consolidated subsidiaries.
−Removed: All intercompany accounts and transactions have been eliminated in consolidation.
−Removed: Since inception, the Company has funded its operations with proceeds from sales of preferred units (including bridge units, which converted into preferred units), payments received in connection with a concluded collaboration agreement, funding from government contracts, licensing agreements and through the sale of the Company’s common and preferred stock.
−Removed: The Company has incurred recurring losses since inception, including net losses of $ 46.4 million and $ 89.8 million for the years ended December 31, 2022 and 2021, respectively.
−Removed: In addition, as of December 31, 2022, the Company had an accumulated deficit of $ 413.9 million.
−Removed: The Company expects to continue to generate operating losses for the foreseeable future.
−Removed: In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued.
−Removed: As of the issuance date of these annual consolidated financial statements, the Company expects its current operating plan, existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of these annual consolidated financial statements.
−Removed: Beyond that point, the Company will require additional funding to fund the development of its product candidates through regulatory approval and commercialization, and to support its continued operations.
−Removed: The Company will seek additional funding through public or private financings, debt financing, collaboration agreements, government grants or other venues.
−Removed: There is no assurance that the Company will be successful in obtaining sufficient funding on acceptable terms, if at all, and it could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could materially adversely affect its business prospects or its ability to continue operations.
−Removed: Summary of Significant Accounting Policies
−Removed: Use of Estimates
−Removed: The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods.
−Removed: Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, revenue recognition, the accrual for clinical trial costs and other
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: research and development expenses and the valuation of share-based awards.
−Removed: There may be changes to those estimates in future periods.
−Removed: On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts and experience.
−Removed: Actual results may differ from those estimates or assumptions.
−Removed: Segment Information
−Removed: The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.
−Removed: The Company’s singular focus is on identifying, developing and commercializing novel treatments for bacterial infections, including MDR bacterial infections, and rare diseases.
−Removed: All of the Company’s tangible assets are held in the United States.
−Removed: Concentrations of Credit Risk and of Significant Suppliers
−Removed: Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents.
−Removed: The Company maintains most of its cash and cash equivalents at one accredited financial institution.
−Removed: The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
−Removed: The Company is dependent on third-party manufacturers to supply products for research and development activities in its programs.
−Removed: In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs.
−Removed: These programs could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients and formulated drugs.
−Removed: As of December 31, 2022, and 2021, the Company had no off-balance sheet risk such as foreign exchange contracts, option contracts, or other hedging arrangements.
−Removed: Cash Equivalents
−Removed: The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents.
−Removed: Cash and cash equivalents include cash held in banks and money market instruments.
−Removed: Marketable Securities
−Removed: Marketable securities consist of investments in corporate obligations with original maturities greater than 90 days.
−Removed: The Company considers its portfolio of investments to be available-for-sale.
−Removed: Accordingly, these investments are recorded at fair value, which is based on quoted market prices.
−Removed: Investments with maturities beyond one year are generally classified as short term, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations.
−Removed: Unrealized gains and losses are reported as a component of accumulated other comprehensive income (loss) in stockholders’
−Removed: Realized gains and losses and declines in value are included as a component of other income (expense), net based on the specific identification method.
−Removed: Any credit impairments are recorded through an allowance account.
−Removed: Property and Equipment
−Removed: Property and equipment are stated at cost less accumulated depreciation and amortization.
−Removed: Depreciation and amortization expense are recognized using the straight-line method over the estimated useful life of each asset as follows:
−Removed: Estimated Useful Life
−Removed: Laboratory equipment
−Removed: Computer software and equipment
−Removed: Office furniture and equipment
−Removed: Manufacturing equipment
−Removed: Leasehold improvements
−Removed: Shorter of life of lease or 5 years
−Removed: Costs for capital assets not yet placed into service are capitalized as construction in progress and are depreciated in accordance with the above guidelines once placed into service.
−Removed: Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in loss from operations.
−Removed: Expenditures for repairs and maintenance are charged to expense as incurred.
−Removed: The Company periodically evaluates whether events and circumstances have occurred that may warrant revision of the estimated useful life of property and equipment.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement.
−Removed: Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and short-term and long-term lease liabilities, as applicable.
−Removed: The Company has elected not to recognize on the balance sheet leases with terms of one year or less.
−Removed: As of December 31, 2022 and 2021, the Company had no short-term leases with terms of one year or less.
−Removed: Options to renew a lease are not included in the Company’s initial lease term assessment unless there is reasonable certainty that the Company will renew.
−Removed: The Company monitors its plans to renew its material leases on a quarterly basis.
−Removed: Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term.
−Removed: Certain adjustments to the right-of-use asset may be required for items such as incentives received.
−Removed: The interest rate implicit in lease contracts is typically not readily determinable.
−Removed: As a result, the Company utilizes its incremental borrowing rate (“IBR”), which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, and in a similar economic environment.
−Removed: Since the Company does not have any debt and has not been rated by any major credit rating agency, the Company’s IBR was estimated by developing a synthetic credit rating for the Company.
−Removed: The Company has elected to account for lease and non-lease components together as a single lease component.
−Removed: Other assets consist of long-term prepayments and deposits.
−Removed: Impairment of Long-Lived Assets
−Removed: Long-lived assets consist of property and equipment and operating lease right-of-use assets.
−Removed: Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable.
−Removed: Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets.
−Removed: If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value.
−Removed: An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount.
−Removed: The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows.
−Removed: Fair Value Measurements
−Removed: Certain assets and liabilities are carried at fair value under GAAP.
−Removed: Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
−Removed: Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
−Removed: Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
−Removed: Level 1—Quoted prices in active markets for identical assets or liabilities.
−Removed: Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
−Removed: Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
−Removed: The Company’s cash equivalents are carried at fair value, determined according to the fair value hierarchy described above (see Note 3).
−Removed: The carrying values of the Company’s accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities.
−Removed: Revenue Recognition - Collaboration Revenue
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The Company has entered into licensing agreements that are evaluated under Accounting Standards Codification, Topic 606 (“Topic 606”), Revenue from Contracts with Customers, through which the Company licenses certain of its product candidates’
−Removed: rights to a third party.
−Removed: Terms of these arrangements include various payment types, typically including one or more of the following:
−Removed: upfront license fees;
−Removed: development, regulatory and commercial milestone payments;
−Removed: payments for manufacturing supply services;
−Removed: and/or royalties on net sales of licensed products.
−Removed: Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services.
−Removed: To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps:
−Removed: (i) identify the contract with a customer;
−Removed: (ii) identify the performance obligations under the agreement;
−Removed: (iii) determine the transaction price, including constraint on variable consideration, if any;
−Removed: (iv) allocate the transaction price to the performance obligations in the contract;
−Removed: and (v) determine how the revenue will be recognized for each performance obligation.
−Removed: The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration to which it is entitled in exchange for the goods or services it transfers to a customer.
−Removed: Once a contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations.
−Removed: Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options.
−Removed: The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations.
−Removed: The exercise of a material right may be accounted for as a contract modification or as a continuation of the contract for accounting purposes.
−Removed: The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract.
−Removed: This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship.
−Removed: Promised goods and services are considered distinct provided that:
−Removed: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract).
−Removed: In assessing whether a promised good or service is distinct in the evaluation of a collaboration arrangement subject to Topic 606, the Company considers factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace.
−Removed: The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract.
−Removed: If a promised good or service is not distinct, the Company is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct.
−Removed: The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (“SSP”) on a relative SSP basis.
−Removed: The SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied.
−Removed: Determining the SSP for performance obligations requires significant judgment.
−Removed: In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs.
−Removed: In certain circumstances, the Company may apply the residual method to determine the SSP of a good or service if the standalone selling price is considered highly variable or uncertain.
−Removed: The Company validates the SSP for performance obligations by evaluating whether changes in the key assumptions used to determine the SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations.
−Removed: If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer.
−Removed: The Company determines the amount of variable consideration by using the expected value method or the most likely amount method.
−Removed: The Company includes the unconstrained amount of estimated variable consideration in the transaction price.
−Removed: The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur.
−Removed: At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price.
−Removed: Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: If an arrangement includes development and regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method.
−Removed: If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price.
−Removed: Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received.
−Removed: In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing.
−Removed: The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less.
−Removed: The Company assessed its revenue-generating arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in the arrangements.
−Removed: For arrangements with licenses of intellectual property that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied.
−Removed: The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output or input method.
−Removed: In determining the accounting treatment for these arrangements, the Company develops assumptions to determine the stand-alone selling price for each performance obligation in the contract.
−Removed: The Company develops the estimated standalone selling price for the license using a discounted cash flow model.
−Removed: To develop this model, the Company applies significant judgement in the determination of the significant assumptions relating to forecasted future revenues, development time lines, the discount rate, and probabilities of technical and regulatory success.
−Removed: The Company develops the estimated standalone selling price for the research and development services using a discounted cash flow model.
−Removed: The assumptions to develop the estimated standalone selling price for the related research and development services include estimates of costs to be incurred to fulfill its obligations associated with the performance of the research and development services, plus a reasonable margin.
−Removed: Government Tax Incentives
−Removed: For available government tax incentives that the Company may earn without regard to the existence of taxable income and that require the Company to forego tax deductions or the use of future tax credits and net operating loss carryforwards, the Company classifies the funding recognized as a reduction of the related qualifying research and development expenses incurred.
−Removed: Since the fourth quarter of 2016, the Company’s operating subsidiary in Australia has met the eligibility requirements to receive a tax incentive for qualifying research and development activities.
−Removed: The Company recognizes these incentives as a reduction of research and development expenses in the consolidated statements of operations and comprehensive loss in the same period that the related qualifying expenses are incurred.
−Removed: Reductions of research and development expense recognized upon incurring qualifying expenses in advance of receipt of tax incentive payments are recorded in the consolidated balance sheet as tax incentive receivables.
−Removed: Research and Development Costs
−Removed: Research and development costs are expensed as incurred.
−Removed: Research and development expenses are comprised of costs incurred in performing research and development activities, including personnel salaries, share-based compensation and benefits, allocated facilities costs, depreciation, manufacturing expenses, costs related to the Company’s government contract and grant arrangements, and external costs of outside vendors engaged to conduct preclinical development activities, clinical trials as well as the cost of licensing technology.
−Removed: Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred.
−Removed: Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses.
−Removed: The prepaid amounts are expensed as the related goods are delivered or the services are performed.
−Removed: In June 2019, the Company entered into a collaboration agreement with the Bill and Melinda Gates Medical Research Institute (the “Gates MRI”) and concluded that the agreement is within the scope of the accounting guidance for collaboration arrangements (see Note 14).
−Removed: Due to the cost-funded nature of the payments and the Company’s assessment that it does not have a vendor/customer relationship with the Gates MRI, the Company recognizes the funding received under the agreement as a reduction to the research and development expenses incurred, as the related expenses are incurred.
−Removed: Clinical Trial and other Research Contract Costs and Accruals
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The Company has entered into various research and development contracts with clinical research organizations and other companies both inside and outside of the United States.
−Removed: These agreements are generally cancelable, and related payments are recorded as research and development expenses as incurred.
−Removed: There may be instances in which payments made to these vendors exceed the level of service provided and will result in a prepayment of the expense.
−Removed: The Company records accruals for estimated ongoing research and clinical trial costs based on the services received and efforts expended pursuant to multiple contracts with these vendors.
−Removed: When evaluating the adequacy of the accrued liabilities, the Company analyzes the progress of the studies or trials, including the phase or completion of events, invoices received and contracted costs.
−Removed: Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period.
−Removed: Actual results could differ from the Company’s estimates.
−Removed: The Company’s historical accrual estimates have not been materially different from the actual costs.
−Removed: Restructuring
−Removed: The Company made estimates and judgments regarding the amount and timing of its restructuring expense and liability, including one-time termination benefits and other exit costs accounted for upon the announcement of the restructuring in May 2022.
−Removed: Restructuring charges are reflected in the Company's consolidated statements of income.
−Removed: All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure.
−Removed: Amounts incurred are classified as general and administrative expenses.
−Removed: Share-Based Compensation
−Removed: The Company issues stock-based awards to employees and directors in the form of stock options and restricted stock units.
−Removed: The Company measures and recognizes compensation expense for its stock-based awards granted to its employees and directors based on the estimated grant date fair value in accordance with ASC 718 and determines the fair value of restricted stock units based on the fair value of its common stock.
−Removed: The Company measures all share-based options granted to employees and directors based on the fair value on the date of grant using the Black-Scholes option-pricing model.
−Removed: Compensation expense of those awards is recognized over the requisite service period, which is generally the vesting period of the respective award.
−Removed: The Company records the expense for awards with service-based conditions using the straight-line method over the requisite service period, net of any actual forfeitures.
−Removed: The Company has also granted certain awards subject to performance-based vesting eligibility and a subsequent partial time-based vesting schedule.
−Removed: Performance-based awards will be recorded as an accrued liability on the Company's condensed consolidated balance sheet and accrued over time as achievement of performance metrics become probable.
−Removed: The Company classifies share-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.
−Removed: Comprehensive Loss
−Removed: Comprehensive loss includes net loss as well as other changes in stockholders’
−Removed: equity that result from transactions and economic events other than those with shareholders.
−Removed: For the years ended December 31, 2022 and 2021, these changes related to unrealized gains and losses on the Company’s available-for-sale marketable securities.
−Removed: There were no reclassifications out of comprehensive loss for the years ended December 31, 2022 and 2021.
−Removed: Net Loss per Share
−Removed: The Company follows the two-class method when computing net income (loss) per share, as the Company has issued shares that meet the definition of participating securities.
−Removed: The two-class method determines net income (loss) per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings.
−Removed: The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed.
−Removed: Net income (loss) per share attributable to common stockholders is calculated based on net income (loss) attributable to Spero Therapeutics, Inc.
−Removed: Basic net income (loss) per share attributable to common stockholders is computed by dividing the net income (loss) attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period.
−Removed: Diluted net income (loss) attributable to common stockholders is computed by adjusting net income (loss) attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities.
−Removed: Diluted net income (loss) per share attributable to common stockholders is computed by dividing the diluted net income (loss) attributable to common stockholders by the weighted
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of common stock equivalents.
−Removed: The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns.
−Removed: Deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse.
−Removed: Changes in deferred tax assets and liabilities are recorded in the provision for income taxes.
−Removed: The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense.
−Removed: Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies.
−Removed: The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized.
−Removed: First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities.
−Removed: If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements.
−Removed: The amount of the benefit that may be recognized is the largest amount that has a greater than 50 % likelihood of being realized upon ultimate settlement.
−Removed: The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties.
−Removed: On December 22, 2017, the Tax Cuts and Jobs Act ("TCJA") was signed into law.
−Removed: Under the TCJA provisions, effective with tax years beginning on or after January 1, 2022, taxpayers can no longer immediately expense qualified research and development expenditures, including all direct, indirect, overhead and software development costs.
−Removed: Taxpayers are now required to capitalize and amortize these costs over five years for research conducted within the United States or 15 years for research conducted abroad.
−Removed: Liability Related to the Sale of Future Royalties
−Removed: Prior to repayment, as discussed further in Note 9, the Company treated the liability related to the sale of future royalties as a debt instrument, amortized under the effective interest rate method over the estimated life of the revenue streams.
−Removed: The Company recognized interest expense thereon using the effective rate, which was based on its estimates of future revenues over the life of the arrangement.
−Removed: The Company periodically assessed its expected revenues using internal projections, imputed interest on the carrying value of the deferred royalty obligation and recorded interest expense using the imputed effective interest rate.
−Removed: To the extent its estimates of future revenues were greater or less than previous estimates or the estimated timing of such payments was materially different than previous estimates, the Company accounted for any such changes by adjusting the effective interest rate on a prospective basis, with a corresponding impact to the reclassification of the deferred royalty obligation.
−Removed: The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs required that the Company made estimates that could impact the short-term and long-term classification of such costs, as well as the period over which such costs were amortized.
−Removed: Derivative Liability
−Removed: In connection with certain transactions, the Company has identified certain embedded derivatives, which are recorded as liabilities on the Company’s consolidated balance sheet and are remeasured to fair value at each reporting date until the derivative is settled.
−Removed: Changes in the fair value of the derivative liabilities are recognized as other income (expense) in the consolidated statement of operations and comprehensive loss.
−Removed: Recently Issued and Adopted Accounting Pronouncements
−Removed: From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date.
−Removed: Unless otherwise noted, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its condensed consolidated financial statements and disclosures.
−Removed: In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions .
−Removed: The ASU clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value.
−Removed: The ASU also clarifies that an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction and requires specific disclosures for equity securities
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: subject to contractual sale restrictions.
−Removed: These changes will become effective for the Company after December 15, 2023.
−Removed: The Company early adopted this standard during the fourth quarter of 2022 and it did not have a material impact on its consolidated financial statements and related disclosures.
−Removed: In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740):
−Removed: Simplifying the Accounting for Income Taxes , amended guidance on the accounting and reporting of income taxes.
−Removed: The guidance is intended to simplify the accounting for income taxes by removing exceptions related to certain intraperiod tax allocations and deferred tax liabilities;
−Removed: clarifying guidance primarily related to evaluating the step-up tax basis for goodwill in a business combination;
−Removed: and reflecting enacted changes in tax laws or rates in the annual effective tax rate.
−Removed: The amended guidance is effective for interim and annual periods in 2021.
−Removed: Early adoption is permitted.
−Removed: The application of the amendments in the new guidance are to be applied on a retrospective basis, on a modified retrospective basis through a cumulative-effect adjustment to retained earnings or prospectively, depending on the amendment.
−Removed: This standard became effective for the Company on January 1, 2021, and did not have a material impact on its consolidated financial statements and related disclosures.
−Removed: Fair Value Measurements and Marketable Securities
−Removed: The following tables present information about the Company’s assets and liabilities that are measured at fair value on a recurring basis (in thousands):
−Removed: Fair Value Measurements at December 31, 2022 Using:
−Removed: Cash equivalents:
−Removed: Money market funds
−Removed: Total cash equivalents
−Removed: Fair Value Measurements at December 31, 2021 Using:
−Removed: Cash equivalents:
−Removed: Money market funds
−Removed: Corporate bonds
−Removed: Total cash equivalents
−Removed: Marketable securities:
−Removed: Corporate bonds
−Removed: Commercial paper
−Removed: Total marketable securities
−Removed: Total cash equivalents and marketable securities
−Removed: Derivative liability
−Removed: Excluded from the tables above is cash of $ 0.9 million and $ 0.6 million as of December 31, 2022 and 2021, respectively.
−Removed: During the years ended December 31, 2022 and 2021, there were no transfers between Level 1, Level 2 and Level 3 categories.
−Removed: Marketable Securities
−Removed: The Company’s marketable securities are classified as Level 2 assets under the fair value hierarchy as these assets were primarily determined from independent pricing sources, which generally derive security prices from recently reported trades for identical or similar securities.
−Removed: The Company evaluated debt securities with unrealized losses for any expected credit losses and determined unrealized losses on these securities were related to non-credit factors.
−Removed: Additionally, the Company currently does no t intend to and is not required to sell these investments prior to an anticipated recovery in value.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The Company did not have any assets classified as marketable securities as of December 31, 2022 .
−Removed: The following table summarizes the gross unrealized gains and losses of the Company’s marketable securities as of December 31, 2021 (in thousands):
−Removed: December 31, 2021
−Removed: Corporate bonds
−Removed: Commercial paper
−Removed: As of December 31, 2021, all of the Company’s marketable securities had remaining contractual maturity dates of one year or less from the respective consolidated balance sheet date.
−Removed: Embedded Derivative
−Removed: Liability related to change of control
−Removed: During the year ended December 31, 2022, in connection with the termination of the Revenue Interest Agreement (as defined below) (see Note 9), the Company classified $ 0.1 million as a derivative liability on its condensed consolidated balance sheet because of an embedded feature that represented a conditional obligation to pay HCR (as defined below) an additional cash amount upon a change of control.
−Removed: The Company remeasured the derivative liability to fair value at each reporting date until it expired on December 31, 2022, and recognized changes in the fair value of the derivative liability as a component of other income (expense) in the condensed consolidated statement of operations and comprehensive loss.
−Removed: The Company valued the change of control provision under the Revenue Interest Termination Agreement, dated June 7, 2022, by and between the Company and HCR, using a series of Black-Scholes-Merton option pricing models.
−Removed: The assumptions used in the valuation model include (1) the Company's estimates of the probability of a change of control event occurring prior to or as of December 31, 2022, (2) the Company's common stock closing stock price as of June 7, 2022, (3) the Company's fully-diluted number of shares of common stock outstanding as of June 7, 2022, (4) volatility, (5) risk-free rate, and (6) the Company's credit-risk-adjusted discount rate.
−Removed: The fair value of the derivative liability upon issuance in June 2022 was $ 0.1 million, and was classified as Level 3 liability under the fair value hierarchy.
−Removed: As of December 31, 2022 the fair value of the derivative liability expired, and as such, was reduced by $ 0.1 million to zero .
−Removed: Liability related to the sale of future royalties
−Removed: During the year ended December 31, 2021, in connection with the liability related to the sale of future royalties, the Company classified a derivative liability on its consolidated balance sheet at inception of its Revenue Interest Financing Agreement because there were embedded instruments that represented a conditional obligation to pay HCR the final payment.
−Removed: The fair value of the derivative liability upon issuance in October 2021 was $ 1.0 million, and was classified as Level 3 liability under the fair value hierarchy.
−Removed: As of December 31, 2021 the fair value of the derivative liability decreased by $ 0.2 million to $ 0.8 million, primarily due to the passage of time and changes in the market volatility and underlying credit risk inputs.
−Removed: The Revenue Interest Agreement was terminated on June 7, 2022, and as such, the fair value of this derivative liability was reduced to zero.
−Removed: The fair value for the liability related to the sale of future royalties at the time of the initial transaction was based on the Company's current estimates of future royalties expected to be paid to HCR over the remaining patent life of the product, which were considered Level 3 inputs (see Note 9).
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Property and Equipment, Net
−Removed: Property and equipment, net consisted of the following (in thousands):
−Removed: Leasehold improvements
−Removed: Manufacturing equipment
−Removed: Computer software and equipment
−Removed: Office furniture and equipment
−Removed: Accumulated depreciation and amortization
−Removed: Property and equipment decreases during the year ended December 31, 2022 were primarily related to impairments due to our strategic restructuring announced in May 2022.
−Removed: Property and equipment increases during the year ended December 31, 2021 primarily related to office furniture and equipment and construction-in-progress related to the expansion of Company’s leased office space (see Note 5).
−Removed: Depreciation and amortization expense related to property and equipment was $ 0.7 million and $ 0.6 million for the years ended December 31, 2022 and 2021, respectively.
−Removed: Operating Leases
−Removed: The Company has entered into, and subsequently amended, an operating lease agreement with U.S.
−Removed: REIF Central Plaza Massachusetts, LLC with respect to its corporate headquarters located at 675 Massachusetts Avenue, Cambridge, Massachusetts where the Company leases approximately 23,400 square feet of office space.
−Removed: The Company's lease extends through July 2027 .
−Removed: For the years ended December 31, 2022 and 2021, the components of operating lease expense were as follows (in thousands):
−Removed: Operating lease expense
−Removed: Statement of Operations Location
−Removed: December 31, 2022
−Removed: December 31, 2021
−Removed: Fixed operating lease expense
−Removed: Research and development expense
−Removed: General and administrative expense
−Removed: Variable operating lease expense
−Removed: Research and development expense
−Removed: General and administrative expense
−Removed: Total operating lease expense
−Removed: Supplemental cash flow information related to the Company’s operating leases for the years ended December 31, 2022 and 2021, was as follows (in thousands):
−Removed: December 31, 2022
−Removed: December 31, 2021
−Removed: Cash paid for amounts included in the measurement of lease liabilities:
−Removed: Operating cash flows from operating leases
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The following table presents the lease balances within the consolidated balance sheet, weighted average remaining lease term, and the weighted average discount rates related to the Company’s operating and finance leases as of December 31, 2022 and 2021 (in thousands, except for the weighted average remaining lease term and the weighted average discount rate):
−Removed: Lease Assets and Liabilities
−Removed: Classification
−Removed: December 31, 2022
−Removed: December 31, 2021
−Removed: Operating lease right-of-use assets
−Removed: Property and equipment, net
−Removed: Total leased assets
−Removed: Operating lease liabilities
−Removed: Non-current operating lease liabilities
−Removed: Total lease liabilities
−Removed: Weighted average remaining lease term (in years)
−Removed: Weighted average discount rate
−Removed: The following table presents the maturity of the Company’s operating lease liabilities as of December 31, 2022 (in thousands):
−Removed: Years Ending December 31,
−Removed: Total future minimum lease payments
−Removed: Less imputed interest
−Removed: Total operating lease liabilities
−Removed: Accrued Expenses and Other Current Liabilities
−Removed: Accrued expenses and other current liabilities consisted of the following (in thousands):
−Removed: December 31, 2022
−Removed: December 31, 2021
−Removed: Accrued external research and development expenses
−Removed: Accrued payroll and related expenses
−Removed: Accrued professional fees
−Removed: Accrued restructuring expenses
−Removed: Accrued other
−Removed: Total Accrued expenses and other current liabilities
−Removed: Convertible Preferred Shares
−Removed: Series A Convertible Preferred Shares
−Removed: The Company has designated 2,220 of the 10,000,000 authorized shares of preferred stock as Series A Preferred Stock.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Each share of Series A Preferred Stock is convertible into 1,000 shares of common stock at any time at the option of the holder, provided that the holder will be prohibited from converting the Series A Preferred Stock into shares of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99 % of the total number of shares of common stock then issued and outstanding, subject to certain exceptions.
−Removed: In the event of the Company’s liquidation, dissolution, or winding up, holders of Series A Preferred Stock will receive a payment equal to $ 0.001 per share of Series A Preferred Stock before any proceeds are distributed to the holders of common stock.
−Removed: Shares of Series A Preferred Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the then outstanding Series A Preferred Stock will be required to amend the terms of the Series A Preferred Stock.
−Removed: As such, the Company classified the Series A Preferred Stock within permanent equity in its consolidated balance sheet.
−Removed: Series B Convertible Preferred Shares
−Removed: The Company has designated 1,000 of the 10,000,000 authorized shares of preferred stock as Series B Preferred Stock.
−Removed: Each share of Series B Preferred Stock is convertible into 1,000 shares of common stock at any time at the option of the holder, provided that the holder will be prohibited from converting the Series B Preferred Stock into shares of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99 % of the total number of shares of common stock then issued and outstanding, subject to certain exceptions.
−Removed: In the event of the Company’s liquidation, dissolution, or winding up, holders of Series B Preferred Stock will receive a payment equal to $ 0.001 per share of Series B Preferred Stock before any proceeds are distributed to the holders of common stock and equal to any distributions to the holders of Series A Preferred Stock.
−Removed: Shares of Series B Preferred Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the then outstanding Series B Preferred Stock will be required to amend the terms of the Series B Preferred Stock.
−Removed: As such, the Company has classified the Series B Preferred Stock within permanent equity in its consolidated balance sheet.
−Removed: Series C Convertible Preferred Shares
−Removed: The Company has designated 3,333 of the 10,000,000 authorized shares of preferred stock as Series C Preferred Stock.
−Removed: Each share of Series C Preferred Stock is convertible into 1,000 shares of common stock at any time at the option of the holder, provided that the holder will be prohibited from converting the Series C Preferred Stock into shares of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99 % of the total number of shares of common stock then issued and outstanding, subject to certain exceptions.
−Removed: In the event of the Company’s liquidation, dissolution, or winding up, holders of Series C Preferred Stock will receive a payment equal to $ 0.001 per share of Series C Preferred Stock before any proceeds are distributed to the holders of common stock and equal to any distributions to the holders of Series A Preferred Stock and Series B Preferred Stock.
−Removed: Shares of Series C Preferred Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the then outstanding Series C Preferred Stock will be required to amend the terms of the Series C Preferred Stock.
−Removed: As such, the Company has classified the Series C Preferred Stock within permanent equity in its consolidated balance sheet.
−Removed: Series D Convertible Preferred Shares
−Removed: The Company has designated 3,215,000 of the 10,000,000 authorized shares of preferred stock as Series D Preferred Stock.
−Removed: The shares of Series D Preferred Stock are convertible on a one-to-one basis into shares of common stock at any time at the option of the holder, provided that the holder will be prohibited from converting the Series D Preferred Stock into shares of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99 % of the total number of shares of common stock then issued and outstanding, subject to certain exceptions.
−Removed: In the event of the Company’s liquidation, dissolution, or winding up, holders of Series D Preferred Stock will receive a payment equal to $ 0.001 per share of Series D Preferred Stock before any proceeds are distributed to the holders of common stock and equal to any distributions to the holders of Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock.
−Removed: Shares of Series D Preferred Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the then outstanding Series D Preferred Stock will be required to amend the terms of the Series D Preferred Stock.
−Removed: As such, the Company has classified the Series D Preferred Stock within permanent equity in its consolidated balance sheet.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: In February 2021, a holder of the Company’s Series B Preferred Stock elected to convert 62 shares of Series B Preferred Stock into 62,000 shares of the Company’s common stock, pursuant to such holder’s rights under the certificate of designation for such Series B Preferred Stock.
−Removed: In addition, a holder of the Company’s Series C Preferred Stock elected to convert 73 shares of Series C Preferred Stock into 73,000 shares of the Company’s common stock, pursuant to such holder’s rights under the certificate of designation for such Series C Preferred Stock.
−Removed: In June 2022, a holder of the Company’s Series B Preferred Stock elected to convert 938 shares of Series B Preferred Stock into 938,000 shares of the Company’s common stock, pursuant to such holder’s rights under the certificate of designation for such Series B Preferred Stock.
−Removed: In addition, a holder of the Company’s Series D Preferred Stock elected to convert 942,000 shares of Series D Preferred Stock into 942,000 shares of the Company’s common stock, pursuant to such holder’s rights under the certificate of designation for such Series D Preferred Stock.
−Removed: In September 2022, a holder of the Company’s Series C Preferred Stock elected to convert the remaining 2,214 shares of Series C Preferred Stock into 2,214,000 shares of the Company’s common stock, pursuant to such holder’s rights under the certificate of designation for such Series C Preferred Stock.
−Removed: In addition, a holder of the Company’s Series D Preferred Stock elected to convert the remaining 2,273,000 shares of Series D Preferred Stock into 2,273,000 shares of the Company’s common stock, pursuant to such holder’s rights under the certificate of designation for such Series D Preferred Stock.
−Removed: As of December 31, 2022, all of the Company's shares of preferred stock have been converted to common stock.
−Removed: “At-the-Market”
−Removed: On March 11, 2021, the Company entered into a sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.
−Removed: (“Cantor”) and filed a universal shelf registration statement on Form S-3 (Registration No.
−Removed: 333-254170), and pursuant to which the Company registered for sale up to $ 300.0 million of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine, including up to $ 75.0 million of its common stock available for issuance pursuant to the “at-the-market”
−Removed: offering program Sales Agreement.
−Removed: Under the Sales Agreement, Cantor may sell shares of the Company’s common stock by any method permitted by law deemed to be an “at the market”
−Removed: offering as defined in Rule 415 of the Securities Act, subject to the terms of the Sales Agreement.
−Removed: The Company’s universal shelf registration statement on Form S-3 (Registration No.
−Removed: 333-254170) became effective on March 29, 2021.
−Removed: During year ended December 31, 2022 the Company sold 5,963,294 shares of its common stock under the Sales Agreement at an average price of approximately $ 2.46 per share for aggregate gross proceeds of approximately $ 14.7 million prior to deducting sales commissions.
−Removed: Subsequent to December 31, 2022, the Company did not sell any shares of its common stock under the Sales Agreement.
−Removed: GSK License and Share Purchase Agreements
−Removed: Concurrently with the execution of the GSK License Agreement, on September 21, 2022 (the “GSK Effective Date”), the Company entered into a stock purchase agreement (the “GSK SPA”) with Glaxo Group Limited (“GGL”), an affiliate of GSK, which closed on November 7, 2022 (the “GSK Closing Date”), and pursuant to which GGL purchased on the GSK Closing Date 7,450,000 shares (the “GSK Shares”) of the Company’s common stock at a purchase price of approximately $ 1.20805 per share, which represented a discount on the closing price on November 4, 2022, for an aggregate purchase price of $ 9.0 million.
−Removed: The GSK SPA contains certain standstill, lock-up and registration rights provisions.
−Removed: Upon closing, the Company recorded the fair market value of the shares issued in stockholders’
−Removed: equity in its condensed consolidated balance sheet.
−Removed: The fair market value of 7,450,000 shares of the Company's common stock issued under the GSK SPA was $ 10.3 million.
−Removed: The common stock issued under the GSK SPA were valued using an option pricing valuation model as the shares are subject to certain holding period restrictions.
−Removed: The Company accounted for the associated discount of $ 1.3 million as a freestanding equity-linked instrument under ASC 815.
−Removed: The discount was allocated as consideration for the GSK License Agreement and evaluated under ASC 606.
−Removed: The discount was determined not to be constrained and was included in the calculation of the total transaction price related to the GSK License Agreement as of the effective date of the transaction.
−Removed: Refer to Note 14 for further discussion.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The GSK Shares were issued and sold without registration under the Securities Act in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder and in reliance on similar exemptions under applicable state laws.
−Removed: Refer to Note 14 for further discussion.
−Removed: Pfizer License and Share Purchase Agreements
−Removed: On June 30, 2021, the Company agreed to sell 2,362,348 shares of common stock to Pfizer Inc.
−Removed: (“Pfizer”) pursuant to a Share Purchase Agreement (the “Pfizer Purchase Agreement”), at a price of $ 16.93 per share, which represented a premium over the most recent closing price on June 30, 2021, for an aggregate purchase price of $ 40.0 million.
−Removed: No shareholder approval was required for the sale of the shares.
−Removed: Pfizer is an accredited investor as defined in the Securities Act, and the shares were sold pursuant to exemptions from registration under Regulation D of the Securities Act.
−Removed: The Company has not filed a registration statement with the SEC covering the resale of the shares and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws.
−Removed: The fair market value of 2,362,348 shares of the Company's common stock issued to Pfizer under the Pfizer Purchase Agreement was $ 27.5 million.
−Removed: The common stock issued under the Pfizer Purchase Agreement were valued using an option pricing valuation model as the shares are subject to certain holding period restrictions.
−Removed: The Company accounted for the associated premium of $ 12.5 million as a freestanding equity-linked instrument under ASC 815.
−Removed: The premium was allocated as consideration for the Company's license agreement with Pfizer (the “Pfizer License Agreement”) and evaluated under ASC 606.
−Removed: The premium was determined not to be constrained and was included in the calculation of the total transaction price related to the Pfizer License Agreement as of June 30, 2021.
−Removed: Refer to Note 14 for further discussion.
−Removed: The closing of the sale of the shares pursuant to the Pfizer Purchase Agreement occurred on July 1, 2021.
−Removed: Upon closing, the Company recorded the fair market value of the shares issued in stockholders’
−Removed: equity in its condensed consolidated balance sheet.
−Removed: Charter Amendment
−Removed: On August 17, 2021, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to increase the number of shares of the Company’s common stock authorized for issuance from 60,000,000 shares to 120,000,000 shares (the “Charter Amendment”).
−Removed: The Charter Amendment was approved by the Company’s stockholders at the annual meeting of stockholders held on August 17, 2021.
−Removed: Share-Based Compensation
−Removed: 2017 Stock Incentive Plan
−Removed: On June 28, 2017, the Company’s shareholders approved the 2017 Stock Incentive Plan (the “2017 Plan”).
−Removed: The 2017 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock grants and stock-based awards.
−Removed: The 2017 Plan is administered by the board of directors, or at the discretion of the board of directors, by a committee of the board.
−Removed: The exercise prices, vesting and other restrictions are determined at the discretion of the board of directors, or their committee if so delegated, except that the exercise price per share of stock options may not be less than 100 % of the fair market value of the share of common stock on the date of grant and the term of stock option may not be greater than ten years .
−Removed: The number of shares initially reserved for issuance under the 2017 Plan was 1,785,416 shares of common stock.
−Removed: The shares of common stock underlying any awards that are forfeited, cancelled, repurchased or are otherwise terminated by the Company under the 2017 Plan will be added back to the shares of common stock available for issuance under the 2017 Plan.
−Removed: On October 18, 2017, the Company’s shareholders approved an amendment to the 2017 Plan, which became effective upon the completion of the Company’s initial public offering, to increase the total number of shares reserved for issuance under the 2017 Plan from 1,785,416 to 2,696,401 .
−Removed: Additionally, the number of shares of common stock that may be issued under the 2017 Plan would be automatically increased on each January 1, beginning with the fiscal year ending December 31, 2019 and continuing for each fiscal year until, and including, the fiscal year ending December 31, 2027, equal to the lowest of (i) 607,324 shares of common stock, (ii) 4 % of the outstanding shares of common stock on such date and (iii) an amount determined by the Company’s board of directors or compensation committee.
−Removed: On August 17, 2021, the Company's shareholders approved amendments to the 2017 Plan.
−Removed: The amendments provided for the following:
−Removed: (i) increased the number of shares of the Company’s common stock authorized for issuance under the 2017 Plan by
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 3,170,254 shares, (ii) removed the “evergreen”
−Removed: provision historically included in the 2017 Plan, and (iii) made certain other amendments.
−Removed: In September 2022, the Company's shareholders approved an amendment to the 2017 Plan to increase the number of shares of the Company’s common stock authorized for issuance under the 2017 Plan by 2,000,000 shares.
−Removed: As of December 31, 2022 , there were 4,382,875 shares remaining available to be issued under the 2017 Plan, as amended.
−Removed: 2019 Equity Incentive Plan
−Removed: On March 11, 2019, the Company adopted the 2019 Inducement Equity Incentive Plan (the “2019 Inducement Plan”) to reserve 331,500 shares of its common stock to be used exclusively for grants of awards to individuals that were not previously employees or directors of the Company as a material inducement to such individuals’
−Removed: entry into employment with Spero within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules.
−Removed: The terms and conditions of the 2019 Inducement Plan are substantially similar to those of the 2017 Plan.
−Removed: In June 2020, the board of directors approved an amendment to the 2019 Inducement Plan to increase the number of shares of common stock authorized for issuance under the 2019 Inducement Plan by 700,000 shares.
−Removed: In December 2022, the board of directors approved an amendment to the 2019 Inducement Plan to increase the number of shares of common stock authorized for issuance under the 2019 Inducement Plan by 875,000 shares.
−Removed: As of December 31, 2022 , there were 1,030,096 shares remaining available to be issued under the 2019 Inducement Plan, as amended.
−Removed: The following table summarizes stock option activity for all of our plans during 2022:
−Removed: 2019 Inducement Plan
−Removed: Total Number of Stock Options
−Removed: Outstanding as of December 31, 2021
−Removed: Forfeited or cancelled
−Removed: Outstanding as of December 31, 2022
−Removed: As of December 31, 2022 , a total of 11,595,127 shares have been authorized and reserved for issuance under all equity plans and 5,412,971 shares were available for future issuance under such plans.
−Removed: Stock Option Valuation
−Removed: The fair value of stock options is estimated using the Black-Scholes option-pricing model.
−Removed: The Company does not have sufficient company-specific historical and implied volatility information and it therefore estimates its expected share volatility based on the historical volatility of a set of publicly traded peer companies.
−Removed: The Company expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price.
−Removed: The Company has estimated the expected term of the Company’s stock option awards utilizing the “simplified”
−Removed: method for awards that qualify as “plain-vanilla.”
−Removed: The risk-free interest rate is determined by reference to the U.S.
−Removed: Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award.
−Removed: Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
−Removed: The assumptions that the Company used in the Black-Scholes option-pricing model to determine the fair value of stock option awards granted to employees and directors were as follows, presented on a weighted average basis:
−Removed: Year Ended December 31,
−Removed: Risk-free interest rate
−Removed: Expected term (in years)
−Removed: Expected volatility
−Removed: Expected dividend yield
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The following table summarizes details regarding stock options granted under our equity incentive plans for the year ended December 31, 2022:
−Removed: Number of Shares
−Removed: Weighted Average Exercise Price
−Removed: Weighted Average Contractual Term
−Removed: Aggregate Intrinsic Value
−Removed: (in thousands)
−Removed: Outstanding as of December 31, 2021
−Removed: Forfeited or cancelled
−Removed: Outstanding as of December 31, 2022
−Removed: Outstanding as of December 31, 2022 - vested and expected to vest
−Removed: Exercisable at December 31, 2022
−Removed: The weighted average grant-date fair value of stock options granted during the year ended December 31, 2022 was $ 7.94 per share.
−Removed: The weighted average grant-date fair value of awards granted during the year ended December 31, 2021 was $ 13.37 per share.
−Removed: The aggregate intrinsic value of stock options exercised during the years ended December 31, 2022 and 2021 was approximately $ 0.1 million and $ 1.2 million, respectively.
−Removed: The Company satisfies stock option exercises with newly issued shares of its common stock.
−Removed: As of December 31, 2022 , total unrecognized compensation cost related to unvested stock option grants was approximately $ 11.4 million.
−Removed: This amount is expected to be recognized over a weighted average period of approximately 2.42 years.
−Removed: Restricted Stock Units
−Removed: The Company granted 1,420,750 restricted stock units (“RSUs”) to employees during the year ended December 31, 2022.
−Removed: The following table summarizes RSU activity under all equity plans (excluding performance-based RSUs) during the year months ended December 31, 2022:
−Removed: Weighted Average Grant Date Fair Value
−Removed: Outstanding as of December 31, 2021
−Removed: Vested and released
−Removed: Forfeited or cancelled
−Removed: Outstanding as of December 31, 2022
−Removed: As of December 31, 2022, there was approximately $ 8.1 million of total unrecognized compensation expense related to RSUs, which is expected to be recognized over a weighted-average period of approximately 2.83 years.
−Removed: The fair value of the RSUs is determined on the date of grant based on the market price of the Company’s common stock on that date.
−Removed: Each RSU represents the right to receive one share of the Company’s common stock, $ 0.001 par value per share, upon vesting.
−Removed: Other than RSUs granted as retention awards, the RSUs vest in four equal annual installments, subject to the individual’s continued service to the Company through the applicable vesting date, and are subject to the terms and conditions of the Company’s form of RSU agreement under the 2017 Plan and 2019 Plan.
−Removed: Performance-Based awards
−Removed: In July 2022, as part of the retention awards referenced in Footnote 10, the Company issued awards containing performance-based vesting criteria ("performance-based awards") to be issued on May 31, 2023, with a value of $ 1.7 million based on the common stock price at such time, subject to the discretion of the Company's Board or Compensation Committee to pay in cash or a combination of cash and stock.
−Removed: Performance-based awards will be recorded as an accrued liability on the Company's condensed consolidated balance sheet and accrued over time as achievement of performance metrics become probable.
−Removed: The performance-based awards are eligible for vesting based on the achievement of certain performance criteria by May 31, 2023 relating to pipeline execution, business development, and financial stewardship.
−Removed: Performance-based awards for which the performance criteria have not
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: been achieved as specified by May 31, 2023 will lapse and be forfeited.
−Removed: The performance-based awards will be subject to acceleration of vesting in the event of termination of employment without cause by the Company or by the executive for good reason (each as defined in the executive’s employment agreement).
−Removed: In September 2022, the Company approved an award of 140,000 performance-based stock units as part of an executive inducement grant ("Inducement PSUs").
−Removed: The Inducement PSUs are eligible for vesting based on the same performance criteria, above.
−Removed: To the extent these performance criteria are met by May 31, 2023, 50 % of the Inducement PSUs will vest on September 12, 2023 and 50 % will vest on September 12, 2024.
−Removed: The Company recognized $ 1.0 million of compensation expense associated with performance-based awards and an insignificant amount of expense associated with the Inducement PSUs during the year ended December 31, 2022, as the performance conditions were considered probable of achievement.
−Removed: Share-Based Compensation Expense
−Removed: The Company recorded share-based compensation expense, for both RSUs and stock options in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands):
−Removed: Year Ended December 31,
−Removed: Research and development expenses
−Removed: General and administrative expenses
−Removed: Liability Related to the Sale of Future Royalties
−Removed: On September 29, 2021, the Company entered into a Revenue Interest Financing Agreement (“Revenue Interest Agreement”) with certain entities managed by HealthCare Royalty Management, LLC (“HCR”), pursuant to which the Company sold to HCR the right to receive certain royalty payments from the Company for a purchase price of up to $ 125.0 million.
−Removed: The Company evaluated the terms of the Revenue Interest Agreement and concluded that the features of the investment amount were similar to those of a debt instrument.
−Removed: The Company received gross proceeds of $ 50.0 million from HCR at an initial funding on October 19, 2021.
−Removed: As such, the Company accounted for this transaction as long-term debt as of December 31, 2021.
−Removed: The Company was entitled to receive an additional $ 50.0 million upon FDA approval of tebipenem HBr on or before December 31, 2022, and an additional $ 25.0 million subject to the mutual agreement of the Company and HCR and if the Company met certain minimum tebipenem HBr product sales thresholds in the United States within 12 months from commercial launch.
−Removed: On June 7, 2022, the Company entered into a Revenue Interest Termination Agreement (the “Termination Agreement”) with HCR and HCR Collateral Management, LLC, as collateral agent for HCR under the Revenue Interest Agreement, pursuant to which the parties mutually agreed to terminate the Revenue Interest Agreement between the parties, and certain other related ancillary agreements, arrangements or understandings under or contemplated by the Revenue Interest Agreement and Security Agreement between the Company and HCR.
−Removed: The Company was released from all of its obligations and the rights to any future revenues and collateral reverted back to the Company in return for a cash payment of $ 54.5 million and a potential additional cash amount contingent upon the occurrence of a change of control event.
−Removed: If a change of control event had occurred on or prior to December 31, 2022, the Company would have been obligated to pay to HCR an additional amount within 15 days following the consummation of such change of control transaction, calculated based on the fully-diluted equity value of the Company.
−Removed: If the change of control value was less than $ 100 million, the change of control payment would be $ 4 million, if $ 100 million to $ 200 million, the change of control payment would be $ 4 million plus 6 % of the change of control value in excess of $ 100 million and if above $ 200 million, the change of control payment would be $ 10 million plus 3 % of the change of control value in excess of $ 200 million.
−Removed: The change of control payment is not cumulative, such that only the highest applicable change of control value would apply in calculating the change of control payment.
−Removed: The rights to this contingent payment expired on December 31, 2022.
−Removed: The Company recognized a loss on the extinguishment of $ 3.6 million, as reported on the associated condensed consolidated statement of operations and comprehensive loss.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The following table presents the changes in the liability related to the sale of future royalties under the Revenue Interest Agreement with HCR as of December 31, 2022 (in thousands):
−Removed: December 31, 2022
−Removed: Liability related to sale of future royalties, as of December 31, 2021
−Removed: Repayment of liability
−Removed: Loss on extinguishment of liability
−Removed: Establish change of control derivative liability
−Removed: Interest expense recognized
−Removed: Liability related to sale of future royalties, as of December 31, 2022
−Removed: Restructuring
−Removed: On May 3, 2022, the Company implemented a strategic restructuring initiative and corresponding reduction in workforce.
−Removed: The restructuring initiative and corresponding reduction in workforce was designed to reduce costs and reallocate resources towards the Company’s clinical development programs for SPR720 and SPR206, while maintaining key personnel needed to help preserve the value of the Company’s tebipenem HBr program.
−Removed: The restructuring reduced the Company’s workforce from 146 full-time employees as of December 31, 2021 to 41 full-time employees as of the end of the second quarter of 2022 following the restructuring.
−Removed: During the year ended December 31, 2022, the Company recognized a restructuring charge of $ 11.6 million, the majority of which was incurred in the second quarter of 2022.
−Removed: Restructuring charges included approximately $ 8.6 million of employee related termination costs and $ 3.0 million of other discontinuation costs such as contract termination fees and lease impairment expense.
−Removed: The following tables summarize the restructuring related charges by line item within the Company’s consolidated statements of operations where they were recorded during the year ended December 31, 2022:
−Removed: Year Ended December 31, 2022
−Removed: Research and development
−Removed: General and administrative
−Removed: Severance and other employee costs
−Removed: Total restructuring charges
−Removed: The restructuring charge was included in accrued expenses and other current liabilities in the Company’s condensed consolidated balance sheet.
−Removed: Activity for the quarter is summarized as follows (amounts in thousands):
−Removed: As of December 31, 2022
−Removed: Balance as of December 31, 2021
−Removed: Charge to expense
−Removed: Payments made
−Removed: Write-offs and impairments
−Removed: Balance as of December 31, 2022
−Removed: As of December 31, 2022, the Company had $ 0.4 million remaining in accrued expenses related to restructuring costs on its condensed consolidated balance sheet, of which the majority will be paid by the end of the first quarter of 2023.
−Removed: Retention Awards
−Removed: In June 2022, upon recommendation of the Company's Compensation Committee, the Board of Directors approved retention awards for employees of the Company.
−Removed: Subject to remaining actively employed with the Company through May 31, 2023, the aggregate retention awards include (i) a cash bonus of $ 1.1 million, which was paid on November 30, 2022 and $ 0.2 million as fully vested RSU grants of the same value issued on November 30, 2022 and (ii) a cash bonus of $ 3.2 million payable on May 31, 2023 and $ 0.7 million to be paid in cash or as a fully vested RSU grant of the same value.
−Removed: These amounts are accrued as services are performed through May 31, 2023.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: On July 1, 2022, upon recommendation of the Company's Compensation Committee, the Board of Directors approved a cash and RSU retention award to certain members of the Company's executive leadership team consisting of the following:
−Removed: Subject to the certain members of the Company's executive leadership team remaining actively employed with the Company through May 31, 2023, they shall receive an aggregate of:
−Removed: (i) a cash bonus equal to $ 0.9 million, which was paid on November 30, 2022 and (ii) if certain performance criteria are achieved, a number of shares of common stock to be issued to them on May 31, 2023 having a value of $ 1.7 million based on the common stock price at such time, subject to the discretion of the Board or the Compensation Committee to pay in cash or a combination of cash and stock.
−Removed: The RSUs are eligible for vesting based on the achievement of certain performance criteria by May 31, 2023 relating to pipeline execution, business development, and financial stewardship.
−Removed: RSUs for which the performance criteria have not been achieved as specified by May 31, 2023 will lapse and be forfeited.
−Removed: The RSUs will be subject to acceleration of vesting in the event of termination of employment without cause by the Company or by the executive for good reason (each as defined in the executive’s employment agreement).
−Removed: These awards will be accrued as services are incurred through May 31, 2023.
−Removed: Awards with performance criteria will be accrued as performance metrics are met.
−Removed: During the year ended December 31, 2022, the Company recognized $ 1.0 million of compensation expense associated with these awards (see Note 8) .
−Removed: During the years ended December 31, 2022 and 2021, the Company recorded no income tax benefits for the net operating losses incurred in each year or interim period due to its uncertainty of realizing a benefit from those items.
−Removed: The domestic and foreign components of loss before income taxes were as follows (in thousands):
−Removed: Year Ended December 31,
−Removed: Loss before income taxes
−Removed: A reconciliation of the U.S.
−Removed: federal statutory income tax rate to the Company’s effective income tax rate is as follows:
−Removed: Year Ended December 31,
−Removed: Federal statutory income tax rate
−Removed: Federal and state research and development tax credit
−Removed: State taxes, net of federal benefit
−Removed: Nondeductible items
−Removed: Increase in deferred tax asset valuation allowance
−Removed: Effective income tax rate
−Removed: Net deferred tax assets as of December 31, 2022 and 2021 consisted of the following (in thousands):
−Removed: Net operating loss carryforwards
−Removed: Research and development tax credit carryforwards
−Removed: Capitalized research and development expenses, net
−Removed: Total deferred tax assets
−Removed: Valuation allowance
−Removed: Net deferred tax assets
−Removed: As of December 31, 2022, the Company had U.S.
−Removed: federal and state net operating loss carryforwards of $ 291.9 million and $ 282.9 million, respectively, which may be available to offset future income tax liabilities.
−Removed: The federal NOLs of $ 73.0 million will expire at various dates from 2033 to 2037 and approximately $ 218.9 million can be carried forward indefinitely.
−Removed: The state NOLs begin
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: to expire in 2033 and will expire at various dates through 2039 .
−Removed: In addition, as of December 31, 2022 , the Company had foreign net operating loss carryforwards of $ 4.6 million, which may be available to offset future income tax liabilities and do not expire.
−Removed: As of December 31, 2022 , the Company also had federal and state research and development tax credit carryforwards of $ 11.5 million and $ 2.8 million, respectively, which may be available to offset future income tax liabilities and begin to expire in 2033 and 2028 , respectively.
−Removed: Utilization of the U.S.
−Removed: net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future.
−Removed: These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income.
−Removed: In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50 % over a three-year period.
−Removed: If the Company experiences a change of control, as defined by Section 382, at any time since inception, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required.
−Removed: Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization.
−Removed: The Company completed an analysis under Section 382 through December 31, 2022 and concluded it had experienced ownership changes in the past.
−Removed: However, the ownership changes did not result in a limitation that at this time would materially reduce the total amount of net operating loss carryforwards and credits that can be utilized.
−Removed: The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets.
−Removed: Management has considered the Company’s history of cumulative net losses incurred since inception and its lack of commercialization of any products or generation of any revenue from product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets.
−Removed: Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31, 2022 and 2021.
−Removed: Management reevaluates the positive and negative evidence at each reporting period.
−Removed: Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2022 and 2021 related primarily to the increase in net operating loss carryforwards and research and development tax credit carryforwards, and were as follows (in thousands):
−Removed: Valuation allowance as of beginning of year
−Removed: Increases recorded to income tax provision
−Removed: Valuation allowance as of end of year
−Removed: The Company has no t recorded any amounts for unrecognized tax benefits as of December 31, 2022 or 2021.
−Removed: The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision.
−Removed: As of December 31, 2022 or 2021, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts had been recognized in the Company’s statement of operations and comprehensive loss.
−Removed: The Company has not, as yet, conducted a study of its research and development credit carryforwards.
−Removed: This study may result in an adjustment to the Company’s research and development credit carryforwards;
−Removed: however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position.
−Removed: A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance.
−Removed: The Company had filed separate U.S.
−Removed: income tax returns return for each of its subsidiaries prior to its reorganization in 2015.
−Removed: The Company now files U.S.
−Removed: income tax returns as a U.S.
−Removed: consolidated group.
−Removed: In Massachusetts, the Company files income tax returns as a combined group except for its Massachusetts Securities Corporation subsidiary, which is a separate income tax filing.
−Removed: The statute of limitations for assessment by the Internal Revenue Service and Massachusetts tax authorities remains open for all years since 2019.
−Removed: To the extent the Company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by the Internal Revenue Service or state authorities to the extent utilized in a future period.
−Removed: No federal or state tax audits are currently in process.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), was signed into law in the United States in March 2020.
−Removed: The CARES Act adjusted a number of provisions of the tax code, including the calculation and eligibility of certain deductions and the treatment of net operating losses and tax credits.
−Removed: The enactment of the CARES Act did not result in any material adjustments to the Company’s income tax provision for the year ended December 31, 2022, or to the Company’s net deferred tax assets as of December 31, 2022.
−Removed: On December 22, 2017, the Tax Cuts and Jobs Act ("TCJA") was signed into law.
−Removed: Under the TCJA provisions, effective with tax years beginning on or after January 1, 2022, taxpayers can no longer immediately expense qualified research and development expenditures, including all direct, indirect, overhead and software development costs.
−Removed: Taxpayers are now required to capitalize and amortize these costs over five years for research conducted within the United States or 15 years for research conducted abroad.
−Removed: As a result, the Company capitalized $ 47.6 million of research and development expenses for the year ended December 31, 2022.
−Removed: Commitments and Contingencies
−Removed: License Agreements
−Removed: The Company has entered into license agreements with various parties under which it is obligated to make contingent and non-contingent payments (see Note 14).
−Removed: Operating Leases
−Removed: The Company has entered into an operating lease agreement with U.S.
−Removed: REIF Central Plaza Massachusetts, LLC with respect to its corporate headquarters located at 675 Massachusetts Avenue, Cambridge, Massachusetts (see Note 5).
−Removed: Indemnification Agreements
−Removed: In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties.
−Removed: In addition, the Company has entered into indemnification agreements with members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers.
−Removed: The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited.
−Removed: To date, the Company has not incurred any material costs as a result of such indemnifications.
−Removed: The Company is not aware of any claims under indemnification arrangements that will have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2022 or 2021.
−Removed: Legal Proceedings
−Removed: Two putative class action lawsuits were filed against the Company and certain of its officers in the United States District Court for the Eastern District of New York, one captioned Richard S.
−Removed: Spero Therapeutics, Inc., Ankit Mahadevia, and Satyavrat Shukla, Case No.
−Removed: 1:22-cv-03125, filed on May 26, 2022, and the other captioned Kashif Memon v.
−Removed: Spero Therapeutics, Inc., Ankit Mahadevia, and Satyavrat Shukla Case No.
−Removed: 1:22-cv-04154, filed on July 15, 2022.
−Removed: The parties moved to consolidate the two complaints on July 22, 2022, which were ordered consolidated on August 5, 2022.
−Removed: Memon and stockholder Nabil Saad filed motions for appointment of lead plaintiff/lead counsel on July 25, 2022.
−Removed: Saad withdrew his opposition on August 15, 2022, and Mr.
−Removed: Memon was appointed lead plaintiff on September 19, 2022.
−Removed: The complaint purports to be brought on behalf of stockholders who purchased the Company’s common stock from May 6, 2021 through May 2, 2022 (Mr.
−Removed: Memon’s complaint alleged a six-month longer class period than the complaint originally filed by Mr.
−Removed: The complaint generally alleges that the Company and certain of its officers violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the New Drug Application for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
−Removed: The complaint seeks unspecified damages, interest, attorneys’
−Removed: fees, and other costs.
−Removed: Memon filed an amended complaint on December 5, 2022.
−Removed: The amended complaint generally alleges the same arguments provided in the original complaint.
−Removed: The Company notified the Court of its intention to file a motion to dismiss the amended complaint in its entirety.
−Removed: The Court held a conference on February 22, 2023 and set a date of March 31, 2023 for the Company to file a motion to dismiss.
−Removed: The Company denies any allegations of wrongdoing and intends to vigorously defend against this lawsuit.
−Removed: However, there is no assurance that the Company will be successful in its defense or that insurance will be
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: available or adequate to fund any settlement or judgment or the litigation costs of this action.
−Removed: Moreover, the Company is unable to predict the outcomes or reasonably estimate a range of possible loss at this time.
−Removed: Additional lawsuits against the Company and certain of its officers or directors may be filed in the future.
−Removed: If additional similar complaints are filed, absent new or different allegations that are material, the Company will not necessarily announce such additional filings.
−Removed: Government Contracts
−Removed: In July 2018, the Company was awarded a contract from Biomedical Advanced Research and Development Authority (“BARDA”) of up to $ 44.2 million to develop tebipenem HBr for the treatment of complicated urinary tract infections (“cUTI”) caused by antibiotic resistant Gram-negative bacteria and for assessment against biodefense pathogens.
−Removed: The award committed initial funding of $ 15.7 million over a three-year base period from July 1, 2018 to June 30, 2021 for cUTI development activities.
−Removed: In May 2019, the contract was modified to include additional funding of approximately $ 2.5 million for the development of tebipenem HBr, increasing the amount of the initial committed funding from $15.7 million to approximately $ 18.2 million and increasing the overall potential award to $ 46.8 million.
−Removed: In January 2020, BARDA exercised its first contract option for additional committed funding of $ 15.9 million, increasing the total committed funding to $ 34.0 million and extended the period of performance through November 1, 2021.
−Removed: In October 2022, BARDA extended the period of performance for the first contract option through December 15, 2023.
−Removed: As of December 31, 2022, the balance of the award was subject to BARDA exercising a second option which would entail funding of $ 12.7 million and is exercisable by BARDA subject to, among other things, satisfactory progress and results from the biodefense studies described below.
−Removed: On January 19, 2022, the Company announced that BARDA exercised a new option under the contract.
−Removed: The new option increases the total amount of committed funding by $ 12.9 million to approximately $ 46.9 million, increasing the total potential contract value to $ 59.7 million.
−Removed: In September 2022, remaining funding from the $ 12.9 million option was reprogrammed to support clinical trials for patients with cUTIs, including acute pyelonephritis.
−Removed: The period of performance for this new option extends through December 31, 2025 and does not change the total amount of committed funding or potential contract value.
−Removed: As part of an inter-agency collaboration between BARDA and the DTRA, a series of studies to assess the efficacy of tebipenem HBr in the treatment of infections caused by biodefense threats such as anthrax, plague and melioidosis will be conducted under the direction of Spero.
−Removed: DTRA provides up to $ 10.0 million, in addition to the total potential award from BARDA, to cover the cost of the nonclinical biodefense aspects of the collaborative program for tebipenem HBr.
−Removed: Together, BARDA and DTRA will provide up to $6 9.7 million in total funding for the clinical development and biodefense assessment of tebipenem HBr, of which $ 12.7 million is subject to the exercise of options by BARDA and Spero’s achievement of specified milestones.
−Removed: During the years ended December 31, 2022 and 2021, the Company recognized $ 2.2 million and $ 9.9 million of revenue under this agreement, respectively.
−Removed: Department of Defense
−Removed: On July 1, 2019, the Company received a $ 5.9 million award from the DoD Congressionally Directed Medical Research Programs (“CDMRP”) Joint Warfighter Medical Research Program.
−Removed: The funding supported the further clinical development of SPR206.
−Removed: The award committed non-dilutive funding of $ 5.9 million over a four-year period to cover the costs of select Phase 1 pharmacology studies, a 28-day GLP NHP toxicology study, and microbiological surveillance studies that would be required for a potential NDA submission with the FDA for SPR206.
−Removed: During the years ended December 31, 2022 and 2021, the Company recognized $ 1.0 million and $ 4.5 million in revenue under this agreement, respectively.
−Removed: As of December 31, 2022, all activities under this award were completed and this award was closed out.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: In May 2021, the Company was awarded a five-year contract from the U.S.
−Removed: National Institute of Allergy and Infectious Diseases (“NIAID”) under the Agency’s Omnibus Broad Agency Announcement No.
−Removed: HHS-NIH-NIAID-BAA2020-1 award mechanism to support further development of SPR206.
−Removed: Funding will be used to offset certain expenses related to manufacturing, clinical, non-clinical and regulatory activities.
−Removed: The Company can receive up to $ 23.4 million over a base period and five option periods.
−Removed: As of December 31, 2022, funding for the base period totaling $ 6.2 million has been committed.
−Removed: In December 2022, the contract was modified to include additional funding of approximately $ 0.1 million increasing the amount of base period committed funding from $ 2.1 million to $ 2.2 million.
−Removed: This increased the total potential contract value to $ 23.5 million.
−Removed: In October 2022, NIAID exercised its first option under the contract, committing $ 4.0 million for SPR206 through April 2025.
−Removed: The Company recognized $ 1.7 million and $ 0.4 million under this agreement during the years ended December 31, 2022 and 2021, respectively.
−Removed: In June 2016, the Company entered into agreements with Pro Bono Bio PLC (“PBB”), a corporation organized under the laws of England, and certain of its affiliates, including PBB Distributions Limited and Cantab Anti-Infectives Limited (“CAI”), in order to acquire certain intellectual property and government funding arrangements relating to SPR206.
−Removed: Under these agreements, CAI agreed to submit a request to NIAID to novate the then CAI-held NIAID contract to Spero, which was finalized in December 2017.
−Removed: The NIAID contract provided development funding of up to $ 6.5 million over a base period and three option periods.
−Removed: In March 2021, a contract modification was executed and the performance period for this award was extended through June 15, 2021.
−Removed: As of December 31, 2021, funding for the base period and the first two option periods totaling $ 5.9 million had been committed.
−Removed: The Company did not recognize revenue under this agreement during the year ended December 31, 2022 and recognized $ 0.4 million in revenue under this agreement, during the year ended December 31, 2021.
−Removed: License, Collaboration and Service Agreements
−Removed: The Company has certain obligations under license agreements with third parties that include annual maintenance fees and payments that are contingent upon achieving various development, regulatory and commercial milestones.
−Removed: Pursuant to these license agreements, the Company is required to make milestone payments if certain development, regulatory and commercial milestones are achieved, and may have certain additional research funding obligations.
−Removed: Also, pursuant to the terms of each of these license agreements, when and if commercial sales of a product commence, the Company will pay royalties to its licensors on net sales of the respective products.
−Removed: SPR720 Agreements
−Removed: In June 2019, the Company entered into a collaboration with Gates MRI to develop SPR720 for the treatment of lung infections caused by Mycobacterium tuberculosis.
−Removed: In furtherance of the Gates MRI’s charitable purposes, the Company also granted to Gates MRI a no-cost, exclusive license to develop, manufacture and commercialize SPR720 for the treatment of tuberculosis (“TB”) in low- and middle- income countries.
−Removed: The Gates MRI is responsible for formulating and funding its own research plan for the development of SPR720 for TB.
−Removed: As such, Gates MRI will conduct and fund preclinical and clinical studies for the development of SPR720 against TB.
−Removed: In addition, Gates MRI and the Company will jointly design and manage certain collaborative research activities, which the Company will perform and which will be funded by the Gates MRI.
−Removed: Due to the cost-funded nature of the payments and the Company’s assessment that it does not have a vendor/customer relationship with the Gates MRI, the Company will recognize the funding received under the agreement as a reduction to the research and development expenses incurred, as the related expenses are incurred.
−Removed: The Company did not record a reduction to research and development expense as no activities were funded by Gates MRI during the year ended December 31, 2022.
−Removed: The Company did not record a reduction to research and development expense related to activities funded by Gates MRI during the year ended December 31, 2022 and recorded a $ 1.5 million reduction to research and development expense related to activities funded by Gates MRI during the year ended December 31, 2021.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Vertex License Agreement
−Removed: In May 2016, the Company entered into an agreement with Vertex Pharmaceuticals Incorporated (“Vertex”) whereby Vertex granted the Company certain know-how and a sublicense to research, develop, manufacture and sell products for a proprietary compound, as well as a transfer of materials.
−Removed: In exchange for the know-how, sublicense and materials, Spero paid Vertex an upfront, one-time, nonrefundable, non-creditable fee of $ 0.5 million, which was recognized as research and development expense.
−Removed: As part of the agreement, the Company is obligated to make future milestone payments of up to $ 80.2 million upon the achievement of specified clinical, regulatory and commercial milestones and to pay Vertex tiered royalties, on a product-by-product and country-by-country basis, of a mid-single-digit to low double-digit percentage based on net sales of products licensed under the agreement.
−Removed: During the years ended December 31, 2022 and 2021, the Company did no t record any research and development expense under this agreement and the next milestone under this agreement is not accrued because it is not yet probable.
−Removed: The agreement continues in effect until the expiration of all payment obligations thereunder, with royalty payment obligations continuing on a product-by-product and country-by-country basis until the later of ten years after the first commercial sale of such product in such country or the date of expiration in such country of the last to expire applicable patent.
−Removed: Further, Vertex has the right to terminate the agreement if provided with notification from the Company of intent to cease all development or if no material development or commercialization efforts occur for one year .
−Removed: Tebipenem HBr Agreements
−Removed: GSK License and Share Purchase Agreement
−Removed: On November 7, 2022, the Company closed the transactions contemplated by the GSK License Agreement, which was entered into on September 21, 2022.
−Removed: Pursuant to the terms of the GSK License Agreement, the Company granted GSK an exclusive royalty-bearing license, with the right to grant sublicenses, under the Company’s intellectual property and regulatory documents and a sublicense under certain intellectual property of Meiji Seika Pharma Co.
−Removed: (“Meiji”) and Meiji’s regulatory documents to develop, manufacture and commercialize tebipenem pivoxil and tebipenem HBr and products that contain tebipenem pivoxil and tebipenem HBr (the “GSK Licensed Products”) in all territories, except certain Asian countries previously licensed to Meiji (Japan, Bangladesh, Brunei, Cambodia, China, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam (the “Meiji Territory”)) (the “GSK Territory”).
−Removed: If the Company's license with Meiji is terminated, or if Meiji forfeits or loses its rights to develop, manufacture and commercialize tebipenem HBr and products that contain tebipenem HBr in any countries in the Meiji Territory, then GSK will have an exclusive first right to negotiate with Spero to add any such countries to the GSK Territory.
−Removed: Under the terms of the GSK License Agreement, the Company received an upfront payment of $ 66.0 million for GSK to secure rights to the medicine.
−Removed: Remaining potential payments are milestone and royalty based, and are as follows (in millions):
−Removed: Milestone payments (up to)
−Removed: From FDA acceptance of clinical protocol, commencement of Phase 3 study through NDA submission
−Removed: $ 150.0 (in tranched milestones)
−Removed: Total commercial milestone payments based on first sale (US/EU)
−Removed: Total potential sales milestone payments
−Removed: Low-single digit to low-double digit (if sales exceed $ 1.0 billion) tiered royalties on net product sales
−Removed: Royalties are subject to reduction in the event of third-party licenses, entry of a generic product or expiration of patent and regulatory exclusivity prior to the tenth anniversary of the first commercial sale of a GSK Licensed Product in a particular country.
−Removed: The Company will be responsible for the execution and costs of the follow-up Phase 3 clinical trial of tebipenem HBr.
−Removed: GSK will be responsible for the execution and costs of any additional further development, including additional Phase 3 regulatory filing and commercialization activities for tebipenem HBr in the GSK Territory.
−Removed: The Company will also be responsible for providing and paying for the clinical supply of tebipenem HBr while GSK will be responsible for the costs of the commercial supply of tebipenem HBr.
−Removed: A joint development committee has been established between GSK and the Company to coordinate and review development activities for tebipenem HBr in the United States.
−Removed: Unless earlier terminated due to certain material breaches of the GSK License Agreement or by GSK for convenience, or otherwise, the GSK License Agreement will expire on a jurisdiction-by-jurisdiction and GSK Licensed Product-by-GSK Licensed
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Product basis on the latest to occur of (i) loss of patent exclusivity, (ii) loss of regulatory exclusivity or (iii) the Royalty Term.
−Removed: During the Royalty Term, the Company has agreed not to develop, manufacture or commercialize any oral carbapenem for any indication or any oral antibiotic for cUTI;
−Removed: this restriction does not apply to any third party which acquires control of Spero after the date of the GSK License Agreement if certain conditions are met.
−Removed: The Company has the right to terminate the GSK License Agreement upon a material breach by, or bankruptcy of, GSK.
−Removed: GSK has the right to terminate the GSK License Agreement at any time upon a specified number of days’
−Removed: notice or upon a material breach by, or bankruptcy of, the Company.
−Removed: In addition, in the event that GSK has the right to terminate the GSK License Agreement due to a breach by the Company, GSK may elect not to terminate the GSK License Agreement and in lieu thereof may assume the responsibility and expense of development of tebipenem HBr in the United States, in which event GSK’s obligation to make further development payments to the Company would cease, and/or to reduce all subsequent commercial and sales milestone payments and royalty payments otherwise due by GSK to the Company under the GSK License Agreement by 50 %.
−Removed: The GSK License Agreement contains representations and warranties, other covenants, indemnification provisions and other terms and conditions customary for transactions of the type contemplated by the GSK License Agreement.
−Removed: In support of certain of its rights to indemnification, GSK also has certain rights to suspend payments otherwise owed to the Company, as well as the right to offset payments otherwise owed to the Company against certain indemnifiable claims.
−Removed: Accounting Analysis and Revenue Recognition
−Removed: The Company determined that GSK is a customer and that the GSK License Agreement is within the scope of ASC 606 as licensing intellectual property and performing ongoing research and development services are ordinary activities that are ongoing and central to the Company’s operations.
−Removed: Accordingly, in determining the appropriate amount of revenue to be recognized, the Company performed the following steps:
−Removed: (i) identified the promised goods or services in the contract;
−Removed: (ii) determined whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract;
−Removed: (iii) measured the transaction price, including the constraint on variable consideration;
−Removed: (iv) allocated the transaction price to the identified performance obligations in proportion to their SSP;
−Removed: and (v) recognized revenue when each performance obligation was deemed to be satisfied.
−Removed: Based on that evaluation, the Company identified two performance obligations, related to the license and to research and development services.
−Removed: The Company developed the estimated SSP for the license using a discounted cash flow model.
−Removed: In developing this estimate, the Company applied significant judgment in the determination of the significant assumptions relating to forecasted future cash flows, the discount rate, and the probability of success.
−Removed: The SSP for the research and development services was estimated based on the Company's estimate of costs to be incurred to fulfill its obligations associated with the performance of the research and development services, plus a reasonable margin.
−Removed: The total transaction price is $ 64.7 million, which includes the initial payment of $ 66.0 million and the discount of $ 1.3 million related to the GSK SPA (see Note 7).
−Removed: At contract inception, $ 45.7 million of the initial $ 64.7 million was allocated to the license transfer performance obligation, which was fully satisfied and recognized as revenue upon delivery of the license.
−Removed: The additional $ 19.0 million was allocated to the research and development services obligation and is being recognized over time as services are delivered, estimated to be over a three year period.
−Removed: The potential development milestone payments from the GSK License Agreement will be accounted for as variable consideration under ASC 606.
−Removed: Given the uncertain nature of these payments, the Company determined they were fully constrained as of December 31, 2022 and not included in the transaction price.
−Removed: The Company can also earn sales-based royalties.
−Removed: The Company recognizes revenue for the license performance obligation at a point in time, that is upon transfer of the license to GSK.
−Removed: Control of the license was transferred on the GSK Effective Date and GSK could begin to use and benefit from the license at the GSK Effective Date.
−Removed: In total, the Company recognized $ 46.1 million during the year ended December 31, 2022 related to the GSK License Agreement, which included $ 45.7 million recognized upfront upon the license and know-how transfer and $ 0.4 million related to the research and development service obligation.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The remaining transaction price balance of approximately $ 18.6 million from the GSK License Agreement allocated to the research and development services performance obligation has been recorded as deferred revenue in the condensed consolidated balance sheet.
−Removed: As of December 31, 2022, the research and development services related to the second performance obligation were expected to be recognized as costs are incurred over the project development timeframe.
−Removed: Meiji License Agreement
−Removed: In June 2017, the Company entered into agreements with Meiji, whereby Meiji granted to the Company a license under certain patents, know-how and regulatory documentation to research, develop, manufacture and sell products containing a proprietary compound in the licensed territory.
−Removed: In exchange for the license, the Company paid Meiji an upfront, one-time, nonrefundable, non-creditable fee of $ 0.6 million, which was recognized as research and development expense.
−Removed: In October 2017, the Company paid a $ 1.0 million milestone payment to Meiji upon the enrollment of the first patient in the Company’s Phase 1 clinical trial of tebipenem HBr.
−Removed: The payment was recorded as research and development expense in the statement of operations and comprehensive loss for the year ended December 31, 2017.
−Removed: The Company paid Meiji approximately $ 1.6 million during the fourth quarter of 2018 related to fixed assets which will be used in manufacturing related activities at Meiji.
−Removed: This equipment has been capitalized as property and equipment in the consolidated balance sheet as of December 31, 2022.
−Removed: In October 2021 , the Company paid a $ 1.0 million milestone payment to Meiji upon submission of a NDA to the FDA for tebipenem HBr.
−Removed: As part of the agreement, the Company is obligated to make future milestone payments of up to $ 1.0 million as of December 31, 2022 upon the achievement of specified regulatory milestones, to pay royalties, on a product-by-product and country-by-country basis, of a low single-digit percentage based on net sales of products licensed under the agreement and to pay Meiji a low double-digit percentage of any sublicense fees received by the Company up to a maximum amount of $ 7.5 million, of which the Company paid $ 6.6 million as of December 31, 2022 and was recorded as research and development expense in the Company's consolidated statement of operations.
−Removed: The agreement continues in effect until the expiration of all payment obligations thereunder (including royalty payments and licensee revenue) on a product-by-product and country-by-country basis, unless earlier terminated by the parties.
−Removed: Pursuant to the terms of the agreement, in addition to each party’s right to terminate the agreement upon the other party’s material breach (if not cured within a specified period after receipt of notice) or insolvency, the Company also has unilateral termination rights (i) in the event that the Company abandons the development and commercialization of tebipenem HBr for efficacy, safety, legal or business reasons, and (ii) under certain circumstances arising out of the head license with a global pharmaceutical company.
−Removed: Savior Service Agreement
−Removed: In November 2018, the Company entered into a service agreement with Savior Lifetec Corporation (“Savior”) to perform technology transfer, process development, analytical method development and testing and formulation development for tebipenem HBr.
−Removed: Per the terms of the agreement, the Company paid Savior a non-refundable supervision fee of approximately $ 2.0 million to manage the buildout of a commercial manufacturing facility.
−Removed: The supervision fee was classified as a prepaid asset on the Company’s balance sheet and was fully amortized as of December 31, 2021.
−Removed: The Company has paid Savior an additional $ 5.3 million for facility build out costs, which is classified as a long-term asset on the Company’s balance sheet as of December 31, 2022.
−Removed: SPR206 Agreements
−Removed: Cantab License Agreements
−Removed: Under the Cantab Agreements, the Company is obligated to make future milestone payments of up to $ 5.8 million upon the achievement of specified clinical and regulatory milestones and a payment of £ 5.0 million ( $ 6.0 million as of December 31, 2022) upon the achievement of a specified commercial milestone.
−Removed: In addition, the Company agreed to pay to PBB royalties, on a product-by-product and country-by-country basis, of a low single-digit percentage based on net sales of products licensed under the agreement.
−Removed: During both the years ended December 31, 2022 and 2021, the Company did no t record any research and development expense related to the achievement of regulatory milestones for SPR206.
−Removed: The Cantab Agreements continue indefinitely, with royalty payment obligations thereunder continuing on a product-by-product and country-by-country basis until the later of ten years after the first commercial sale of such product in such country or the expiration in such country of the last to expire valid claim of any of the applicable patents.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Everest Medicines License Agreement
−Removed: On January 4, 2019, the Company, through its wholly owned subsidiary New Pharma License Holdings Limited (“NPLH”), entered into a license agreement (the “Original Everest License Agreement”), with Everest.
−Removed: Under the terms of the Original Everest License Agreement, the Company granted Everest an exclusive license to develop, manufacture and commercialize SPR206 or products that contain SPR206 (the “Licensed Products”), in Greater China (which includes Mainland China, Hong Kong and Macau), South Korea and certain Southeast Asian countries (the “Territory”).
−Removed: The Company retained development, manufacturing and commercialization rights with respect to SPR206 and Licensed Products in the rest of the world and also retained the right to develop or manufacture SPR206 and Licensed Products in the Territory for use outside the Territory.
−Removed: In addition to the license grant with respect to SPR206, the Company, through its wholly owned subsidiary, Spero Potentiator, Inc., a Delaware corporation, granted Everest a 12 -month exclusive option to negotiate with it for an exclusive license to develop, manufacture and commercialize SPR741 in the Territory.
−Removed: Under the terms of the Original Everest License Agreement, the Company received an upfront payment of $ 3.0 million that was recognized in the first quarter of 2019, comprised of a $ 2.0 million payment to license SPR206 and $ 1.0 million for the exclusive option to negotiate a license to develop SPR741.
−Removed: The Company also received a milestone payment of $ 2.0 million in the fourth quarter of 2020 upon completion and delivery of the results of a clinical study.
−Removed: On January 15, 2021, the Company entered into an amended and restated license agreement (“the Amended Everest License Agreement”) with Everest and Spero Potentiator, Inc., which amended and restated in its entirety the Original Everest License Agreement.
−Removed: The Amended Everest License Agreement modifies the dates and values of certain milestone events related to development and commercialization of SPR206.
−Removed: Everest will now be making more significant investments in the development of SPR206 beyond what was contemplated at the time of the Original Everest License Agreement.
−Removed: The Original Everest License Agreement provided that the Company could receive up to $ 59.5 million upon achievement of certain milestones.
−Removed: The Amended Everest License Agreement provides that the Company may receive up to $ 38.0 million upon achievement of certain milestones, of which $ 2.0 million has been received to date.
−Removed: The Company received milestones of $ 1.5 million related to a clinical study for SPR206, of which the Company received approximately $ 0.8 million upon the initiation of the BAL clinical trial of SPR206 in June 2021 and received the remaining $ 0.7 million upon the delivery of the clinical study report in the second quarter of 2022.
−Removed: In addition, under the Amended Everest License Agreement, the Company assigned patents in the Territory to Everest, rather than licensing such patents to Everest, and the option related to SPR741 and the related provisions have been removed.
−Removed: Under the terms of the Amended Everest License Agreement, the Company is also entitled to receive high single-digit to low double-digit royalties on net sales, if any, of Licensed Products in the Territory following regulatory approval of SPR206.
−Removed: Everest has the right to sublicense to affiliates and third parties in the Territory.
−Removed: Everest is responsible for all costs related to developing, obtaining regulatory approval of and commercializing SPR206 and Licensed Products in the Territory, and is obligated to use commercially reasonable efforts to develop, manufacture and commercialize Licensed Products, including to achieve certain specified diligence milestones within agreed-upon periods.
−Removed: A joint development committee has been established between the Company and Everest to coordinate and review the development, manufacturing and commercialization plans with respect to Licensed Products in the Territory.
−Removed: Unless earlier terminated due to certain material breaches of the contract, or otherwise, the Amended Everest License Agreement will expire on a jurisdiction-by-jurisdiction and Licensed Product-by-Licensed Product basis upon the latest to occur of expiration of the last valid claim under a licensed patent in such jurisdiction, the expiration of regulatory exclusivity in such jurisdiction or ten years after the first commercial sale of such Licensed Product in such jurisdiction.
−Removed: The Amended Everest License Agreement may be terminated in its entirety by Everest upon 90 or 180 days ’
−Removed: prior written notice, depending on the stage of development of the initial Licensed Product.
−Removed: To date, all performance obligations under the contract were fully satisfied.
−Removed: As of December 31, 2022 remaining future milestone payments of $ 34.0 are fully constrained, and will be recognized when and if achievement of those milestones becomes probable.
−Removed: During the year ended December 31, 2022 , the Company recognized approximately $ 0.7 million of revenue under this agreement related to certain milestone achievements.
−Removed: During the year ended December 31, 2021, the Company recognized $ 1.3 million of revenue related to this agreement.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Pfizer License and Share Purchase Agreements
−Removed: On June 30, 2021, the Company and Pfizer entered into the Pfizer License Agreement and the Pfizer Purchase Agreement.
−Removed: Under the terms of the Pfizer License Agreement, the Company granted Pfizer an exclusive royalty-bearing license to develop, manufacture and commercialize SPR206 or products that contain SPR206 (the “Licensed Products”) globally with some territorial exceptions (the “Pfizer Territory”).
−Removed: The Pfizer Territory excludes the United States and the Asian markets previously licensed to Everest, those being the People’s Republic of China, including Hainan Island, the Hong Kong Special Administrative Region of the People’s Republic of China, and the Macau Special Administrative Region of the People’s Republic of China, Taiwan, the Republic of Korea (South Korea), the Republic of Singapore, Malaysian Federation, Kingdom of Thailand, the Republic of Indonesia, Socialist Republic of Vietnam and the Republic of the Philippines).
−Removed: Under the terms of the Pfizer Purchase Agreement, Pfizer purchased 2,362,348 shares of the Company’s common stock at a price of $ 16.93 per share for a total investment of $ 40.0 million.
−Removed: Under the terms of the Pfizer License Agreement, the Company received no other upfront payments but is eligible to receive up to $ 80.0 million in development and sales milestones, and may also receive high single-digit to low double-digit royalties on net sales of SPR206 in the Pfizer Territory.
−Removed: Achievement of these payments cannot be guaranteed.
−Removed: The Company and Pfizer agree that upon Pfizer’s request, the parties will negotiate in good faith regarding procuring a clinical or commercial supply of the compound.
−Removed: The fair market value of 2,362,348 shares of the Company's common stock issued to Pfizer under the Pfizer Purchase Agreement was determined to be $ 27.5 million.
−Removed: The common stock issued under the Pfizer Purchase Agreement were valued using an option pricing valuation model as the shares are subject to certain holding period restrictions.
−Removed: The Company accounted for the associated premium of $ 12.5 million as a freestanding equity-linked instrument under ASC 815.
−Removed: The premium was allocated as consideration for the Pfizer License Agreement and evaluated under ASC 606.
−Removed: The premium was determined not to be constrained and was included in the calculation of the total transaction price related to the Pfizer License Agreement as of June 30, 2021.
−Removed: The Company is responsible for all costs related to developing and obtaining regulatory approval of SPR206 and Licensed Products in the Pfizer Territory, with a focus on the European market, and is obligated to use commercially reasonable efforts, including to achieve certain specified diligence milestones within agreed-upon periods.
−Removed: A joint development committee was established between the Company and Pfizer to coordinate and review the development, manufacturing and commercialization plans with respect to Licensed Products in the Pfizer Territory.
−Removed: Pfizer is responsible for commercializing SPR206 and the Licensed Products in the Pfizer Territory.
−Removed: Unless earlier terminated due to certain material breaches of the contract or by Pfizer’s convenience, or otherwise, the Pfizer License Agreement will expire on a jurisdiction-by-jurisdiction and licensed product-by-licensed product basis after ten years from the effective date.
−Removed: The Pfizer License Agreement will automatically renew for an additional ten-year term unless terminated.
−Removed: Accounting Analysis and Revenue Recognition
−Removed: The Company determined that Pfizer is a customer and that the Pfizer License Agreement is within the scope of ASC 606 as licensing intellectual property and performing ongoing research and development services are ordinary activities that are ongoing and central to the Company’s operations.
−Removed: Accordingly, in determining the appropriate amount of revenue to be recognized, the Company performed the following steps:
−Removed: (i) identified the promised goods or services in the contract;
−Removed: (ii) determined whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract;
−Removed: (iii) measured the transaction price, including the constraint on variable consideration;
−Removed: (iv) allocated the transaction price to the identified performance obligations in proportion to their SSP;
−Removed: and (v) recognized revenue when each performance obligation was deemed to be satisfied.
−Removed: Based on that evaluation, the Company identified two performance obligations, license and know-how transfer and research and development services related to upcoming milestones.
−Removed: The Company determined that the supply agreement is a customer option and not a material right, as the pricing to Pfizer is not at a significant discount.
−Removed: Furthermore, Pfizer has the right to use third parties to manufacture the compound, or to manufacture the compound itself.
−Removed: At contract inception, $ 1.4 million of the then transaction price of $ 12.5 million was allocated to the license and know-how transfer performance obligations, which was fully satisfied and recognized as revenue upon delivery of the license.
−Removed: The additional $ 11.1 million was allocated to the research and development services obligation and is being recognized over time as services are delivered.
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: In the third quarter of 2022, upon the completion of a milestone related to regulatory engagement for SPR206, Pfizer communicated its approval that the milestone was achieved, and the Company received $ 5.0 million under the Pfizer License Agreement, which the Company accounted for as variable consideration under ASC 606 and was added to the transaction price in the third quarter of 2022.
−Removed: Of this $ 5.0 million milestone, $ 0.9 million was recognized during the third quarter of 2022 and the remaining $ 4.1 million was allocated to the research and development services performance obligation and will be recognized over time as the services are delivered.
−Removed: The potential license maintenance fees and development milestone payments from the Pfizer License Agreement will be accounted for as variable consideration under ASC 606.
−Removed: Given the uncertain nature of these payments, the Company determined they were fully constrained as of December 31, 2022 and not included in the transaction price.
−Removed: The Company can also earn sales-based royalties.
−Removed: The Company recognizes revenue for the license performance obligation at a point in time, that is upon transfer of the license to Pfizer.
−Removed: Control of the license was transferred on the Effective Date and Pfizer could begin to use and benefit from the license at the Effective Date.
−Removed: In total, and inclusive of the above, the Company recognized $ 1.8 million during both the twelve months ended December 31, 2022 and 2021, respectively.
−Removed: The remaining transaction price balance of approximately $ 13.9 million from the Pfizer Purchase Agreement allocated to the research and development services performance obligation has been recorded as deferred revenue in the condensed consolidated balance sheet.
−Removed: As of December 31, 2022, the research and development services related to the second performance obligation were expected to be recognized as costs are incurred over the project development timeframe.
−Removed: Net Loss per Share
−Removed: Basic and diluted net loss per share attributable to common stockholders of Spero Therapeutics, Inc.
−Removed: was calculated as follows (in thousands, except share and per share amounts):
−Removed: Year Ended December 31,
−Removed: Net loss attributable to common stockholders
−Removed: Weighted average common shares outstanding, basic and diluted
−Removed: Net loss per share, basic and diluted
−Removed: The Company excluded potentially dilutive securities from the computation of diluted net loss per share as the effect would be to reduce the net loss per share.
−Removed: Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders of Spero Therapeutics, Inc.
−Removed: The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net
−Removed: SPERO THERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
−Removed: Year Ended December 31,
−Removed: Options to purchase common stock
−Removed: Unvested restricted stock units
−Removed: Series A convertible preferred stock (as converted to common shares)
−Removed: Series B convertible preferred stock (as converted to common shares)
−Removed: Series C convertible preferred stock (as converted to common shares)
−Removed: Series D convertible preferred stock (as converted to common shares)
−Removed: Retirement Plan
−Removed: The Company has a defined-contribution plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”).
−Removed: The 401(k) Plan covers all employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pre-tax basis.
−Removed: As currently established, the Company is not required to make any contributions to the 401(k) Plan.
−Removed: The Company made matching contributions to the 401(k) Plan of $ 0.4 million and $ 0.5 million during the years ended December 31, 2022 and 2021, respectively.
−Removed: Subsequent Events
−Removed: The Company has evaluated, for potential recognition and disclosure, events that occurred prior to the date at which the consolidated financial statements were available to be issued.
−Removed: There were no material subsequent events.
−Removed: Subsequent to December 31, 2022, the Company did no t sell any shares of its common stock under the Sales Agreement.
−Removed: Changes in and Disagreements with Accou ntants on Accounting and Financial Disclosure.
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.