Spero Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Spero Therapeutics, Inc. filed its 2023 10-K, detailing its business operations, financial performance, and various strategic agreements.</b>

AI Summary

Spero Therapeutics, Inc. (SPRO) filed a Annual Report (10-K) with the SEC on March 13, 2024. Spero Therapeutics, Inc. filed its 2023 Form 10-K on March 13, 2024, reporting on its fiscal year ending December 31, 2023. The filing details various agreements including GSK, Pfizer, and Meiji license agreements, as well as the Everest License Agreement. It references stock incentive plans such as the 2017 Stock Incentive Plan and the 2019 Inducement Equity Incentive Plan. Key entities mentioned include NIAID, BARDA, and DTRA, indicating government and research collaborations. The report covers financial aspects like retained earnings and research and development expenses for the fiscal years 2022 and 2023.

Why It Matters

For investors and stakeholders tracking Spero Therapeutics, Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of Spero Therapeutics' financial health, R&D activities, and strategic partnerships, which are crucial for investors to assess the company's current standing and future prospects. Details on licensing agreements with major pharmaceutical companies and government agencies offer insights into the company's product development pipeline and potential revenue streams.

Risk Assessment

Risk Level: medium — Spero Therapeutics, Inc. shows moderate risk based on this filing. The company's financial performance and future prospects are heavily dependent on the success of its drug development pipeline and regulatory approvals, which carry inherent risks.

Analyst Insight

Investors should review the detailed breakdown of research and development expenses and licensing agreements to understand the company's investment in future growth and potential market penetration.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting Period)
• 2024-03-13 — Filing Date (10-K Filing)
• 2022 — Fiscal Year (Comparative Financial Data)
• 2023 — Fiscal Year (Comparative Financial Data)

Key Players & Entities

• Spero Therapeutics, Inc. (company) — Filer
• 2023-12-31 (date) — Fiscal Year End
• 2024-03-13 (date) — Filing Date
• GSK (company) — License Agreement
• Pfizer (company) — License Agreement
• Meiji (company) — License Agreement
• NIAID (company) — Collaboration
• BARDA (company) — Collaboration

FAQ

Risk Factors

• Going Concern [high — financial]: The company's ability to continue as a going concern is dependent on its ability to secure additional financing and achieve profitability.
• Drug Development and Approval Risks [high — regulatory]: The development and commercialization of pharmaceutical products are subject to extensive regulatory review and approval processes, which can be lengthy and uncertain.
• Competition [medium — market]: The pharmaceutical market is highly competitive, with many companies developing similar therapies, which could impact Spero's market share and pricing power.
• Reliance on Key Personnel [medium — operational]: The company's success depends on its ability to attract and retain highly qualified scientific and management personnel.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-13: 10-K Filing Date — Date Spero Therapeutics filed its annual report.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value per share SPRO The Nasdaq
• $20 — ections on the United States economy is $20–$35 billion in direct health care costs
• $35 billion — ons on the United States economy is $20–$35 billion in direct health care costs. The chal

Filing Documents

• spro-20231231.htm (10-K) — 3883KB
• spro-ex10_4.htm (EX-10.4) — 146KB
• spro-ex10_8.htm (EX-10.8) — 35KB
• spro-ex10_18.htm (EX-10.18) — 59KB
• spro-ex10_19.htm (EX-10.19) — 111KB
• spro-ex10_34.htm (EX-10.34) — 23KB
• spro-ex10_35.htm (EX-10.35) — 24KB
• spro-ex23_1.htm (EX-23.1) — 3KB
• spro-ex31_1.htm (EX-31.1) — 10KB
• spro-ex31_2.htm (EX-31.2) — 12KB
• spro-ex32.htm (EX-32) — 10KB
• spro-ex97_1.htm (EX-97.1) — 45KB
• img42278772_0.jpg (GRAPHIC) — 20KB
• img162092241_0.jpg (GRAPHIC) — 113KB
• img162092241_1.jpg (GRAPHIC) — 89KB
• img162092241_2.jpg (GRAPHIC) — 24KB
• img162092241_3.jpg (GRAPHIC) — 30KB
• img196655433_0.jpg (GRAPHIC) — 20KB
• 0000950170-24-030767.txt (&nbsp;) — 14392KB
• spro-20231231.xsd (EX-101.SCH) — 2161KB
• spro-20231231_htm.xml (XML) — 1819KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 37 Item 1B. Unresolved Staff Comments 72 Item 1C. Cybersecurity 72 Item 2.

Properties

Properties 74 Item 3.

Legal Proceedings

Legal Proceedings 74 Item 4. Mine Safety Disclosures 74 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 75 Item 6. [Reserved] 75 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 76 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 86 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 88 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 124 Item 9A.

Controls and Procedures

Controls and Procedures 124 Item 9B. Other Information 124 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 124 PART III Item 10. Directors, Executive Officers and Corporate Governance 125 Item 11.

Executive Compensation

Executive Compensation 131 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 140 Item 13. Certain Relationships and Related Transactions, and Director Independence 143 Item 14. Principal Accounting Fees and Services 145 PART IV Item 15. Exhibits, Financial Statement Schedules 146 Item 16. Form 10-K Summary 149 i Forward-Looking Information This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Annual Report on Form 10-K are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue" or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about: the initiation, timing, design, progress and results of, including interim data from, our preclinical studies and clinical trials, and our research and development programs; the regulatory path forward for tebipenem HBr and the potential approval of tebipenem HBr by the U.S. Food and Drug Administration ("FDA"); the potential receipt of milestone payments and royalties on future sales under our License Agreement (the "GSK License Agreement") with GlaxoSmithKline Intellectual Property (No. 3) Limited ("GSK"), and the potential receipt of milestone payments under our other various license and collaboration agreements; our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals; our ability to advance product candidates into, and successful

B usiness

Item 1. B usiness. Overview We are a multi-asset, clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases caused by multi-drug resistant ("MDR") bacterial infections with high unmet need. Our wholly-owned lead product candidate, SPR720, is an oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial ("NTM") pulmonary disease, a rare orphan disease. We believe that SPR720, if successfully developed and approved, has the potential to be the first approved oral agent for first-line treatment of NTM pulmonary disease in treatment-nave and treatment-experienced non-refractory patients. Our partnership-directed programs consist of tebipenem HBr and SPR206. Tebipenem HBr is designed to be the first oral carbapenem-class antibiotic for use to treat complicated urinary tract infections ("cUTIs"), including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options. SPR206 is an intravenous ("IV")-administered antibiotic that has shown activity in preclinical studies against MDR Gram-negative pathogens, including carbapenem-resistant Enterobacterales ("CRE"), Acinetobacter baumannii and Pseudomonas aeruginosa . We are developing SPR206 to treat MDR Gram-negative bacterial infections in the hospital setting. We believe that our novel product candidates, if successfully developed and approved, could provide meaningful benefits to patients suffering from serious rare orphan diseases and life-threatening bacterial infections, in both the community and hospital settings. Since our inception in 2013, we have focused substantially all of our efforts and financial resources on acquiring and developing product and technology rights, building our intellectual property portfolio and conducting research and development activities for our product candidates. We do not have any products approved for sale and have not generated any rev

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View this 10-K filing on SEC EDGAR