Spero Therapeutics, Inc. (NASDAQ:SPRO) Q1 2022 Earnings Conference Call May 16, 2022 4:30 PM ET Company Participants Ted Jenkins - Vice President-Investor Relations Ankit Mahadevia - Chief Executive Officer David Melnick - Chief Medical Officer Sath Shukla - Chief Financial Officer Conference Call Participants Louise Chen - Cantor Ram Selvaraju - H.C. Wainwright Kevin DeGeeter - Oppenheimer Elaine Kim - Berenberg Operator Good afternoon, and welcome to the Spero Therapeutics First Quarter of 2022 Financial ...

[PART I – FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section details the unaudited financial statements, key notes, management's discussion, and market risk disclosures for the quarter ended March 31, 2022 [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This chapter presents the unaudited condensed consolidated financial statements for the quarter ended March 31, 2022, including balance sheet, statements of operations, and cash flows, with key accompanying notes [Condensed Consolidated Financial Statements](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements) Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $72,111 | $112,584 | | Total current assets | $132,704 | $157,872 | | Total assets | $145,830 | $171,072 | | Liability related to the sale of future royalties, current | $50,902 | $0 | | Total current liabilities | $69,199 | $18,670 | | Total liabilities | $83,357 | $82,783 | | Total stockholders' equity | $62,473 | $88,289 | Condensed Consolidated Statements of Operations (in thousands) | Account | Three Months Ended Mar 31, 2022 | Three Months Ended Mar 31, 2021 | | :--- | :--- | :--- | | Total revenues | $2,069 | $7,300 | | Research and development | $16,971 | $18,404 | | General and administrative | $15,305 | $8,299 | | Loss from operations | $(30,207) | $(19,403) | | Net loss | $(32,829) | $(19,423) | | Net loss per share, basic and diluted | $(1.01) | $(0.66) | Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | Three Months Ended Mar 31, 2022 | Three Months Ended Mar 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(28,223) | $(15,479) | | Net cash (used in) provided by investing activities | $(16,064) | $3,003 | | Net cash provided by financing activities | $3,814 | $4,309 | | Net decrease in cash and cash equivalents | $(40,473) | $(8,167) | [Key Notes to Financial Statements](index=11&type=section&id=Key%20Notes%20to%20Financial%20Statements) - The company's product pipeline includes tebipenem HBr for complicated urinary tract infections (cUTIs), SPR720 for non-tuberculous mycobacterial (NTM) infections, and SPR206 for multi-drug resistant (MDR) Gram-negative infections[29](index=29&type=chunk) - The company entered into a Revenue Interest Agreement with HealthCare Royalty Management (HCR), receiving **$50.0 million** upfront, with a requirement to repay the **$50.0 million** plus interest at a **13.5% annual rate** if tebipenem HBr is not approved by the FDA by December 31, 2022, which is accounted for as debt[138](index=138&type=chunk)[140](index=140&type=chunk) - The liability related to the sale of future royalties to HCR stood at **$50.9 million** as of March 31, 2022, with an effective interest rate of **20.8%**[143](index=143&type=chunk)[145](index=145&type=chunk) - The company has various government contracts, including a BARDA award for tebipenem HBr development, which was increased by **$12.9 million** in January 2022 to a total committed funding of approximately **$46.9 million**[102](index=102&type=chunk) - On May 3, 2022, following FDA feedback, the company suspended commercialization activities for tebipenem HBr, initiated a restructuring, and reduced its workforce by approximately **75%** to focus on its SPR720 and SPR206 programs[31](index=31&type=chunk)[149](index=149&type=chunk)[150](index=150&type=chunk) - Management has determined that there is substantial doubt regarding the company's ability to continue as a going concern within one year, citing recurring losses and uncertainty surrounding the approval of tebipenem HBr[34](index=34&type=chunk)[154](index=154&type=chunk)[290](index=290&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic restructuring, financial performance for Q1 2022, and liquidity, highlighting the going concern uncertainty and future funding outlook - The company announced a strategic restructuring on May 3, 2022, to reduce costs and reallocate resources to its clinical programs for SPR720 and SPR206, while continuing dialogue with the FDA on a path forward for tebipenem HBr[159](index=159&type=chunk)[160](index=160&type=chunk) - Existing cash, cash equivalents, and marketable securities of **$122.0 million** as of March 31, 2022, are expected to fund the restructured operating plan through late 2023, though this projection is subject to uncertainty and assumes the repayment of the HCR debt[154](index=154&type=chunk)[204](index=204&type=chunk) Comparison of Operating Results (in thousands) | Line Item | Q1 2022 | Q1 2021 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $2,069 | $7,300 | $(5,231) | | R&D Expenses | $16,971 | $18,404 | $(1,433) | | G&A Expenses | $15,305 | $8,299 | $7,006 | | Loss from Operations | $(30,207) | $(19,403) | $(10,804) | | Net Loss | $(32,829) | $(19,423) | $(13,406) | - The decrease in grant revenue was primarily due to a **$5.6 million** reduction in qualified expenses under the BARDA contract for tebipenem HBr as related activities concluded[181](index=181&type=chunk) - General and Administrative expenses increased by **$7.0 million** year-over-year, mainly due to higher personnel costs and professional fees to support the potential commercialization of tebipenem HBr prior to the decision to suspend these activities[188](index=188&type=chunk)[189](index=189&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section details the company's primary market risk exposures, focusing on interest rate sensitivity and foreign currency fluctuations affecting its financial instruments - As of March 31, 2022, the company held **$122.0 million** in cash, cash equivalents, and marketable securities[213](index=213&type=chunk) - The primary market risk is interest rate sensitivity, where a **50 basis point** increase in rates would hypothetically decrease the portfolio's fair value by **$0.1 million**[213](index=213&type=chunk) [PART II – OTHER INFORMATION](index=39&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section outlines various other information, including significant risk factors impacting the company's operations, financial position, and future prospects [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This chapter details significant risks related to product development, financial position, dependence on third parties, government contracts, and regulatory compliance [Risks Related to Product Development and Commercialization](index=39&type=section&id=Risks%20Related%20to%20Product%20Development%20and%20Commercialization) - The company has suspended commercialization efforts for tebipenem HBr based on FDA feedback suggesting the data package may be insufficient for approval during the current review cycle, making the timing and terms of any potential approval uncertain[219](index=219&type=chunk)[220](index=220&type=chunk)[221](index=221&type=chunk) - The strategic shift to focus on earlier-stage programs, SPR720 and SPR206, carries significant risk, as clinical trials may fail to produce favorable results, encounter delays, or ultimately not lead to commercial products[219](index=219&type=chunk)[222](index=222&type=chunk) - The company faces substantial competition for tebipenem HBr from established oral therapies like Levaquin and Cipro, as well as other product candidates in development[255](index=255&type=chunk)[256](index=256&type=chunk) [Risks Related to Financial Position and Need for Additional Capital](index=49&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) - The Revenue Interest Agreement with HCR requires repayment of the **$50.0 million** initial investment plus **13.5%** annual interest if tebipenem HBr does not receive FDA approval for cUTI by December 31, 2022[284](index=284&type=chunk) - The company has a history of losses and its auditor's report expresses substantial doubt about its ability to continue as a going concern, indicating additional funding will be necessary but may not be available on acceptable terms[289](index=289&type=chunk)[290](index=290&type=chunk)[295](index=295&type=chunk) - The company's ability to use its **$303.7 million** in federal net operating loss (NOL) carryforwards may be limited by Section 382 ownership change rules[303](index=303&type=chunk) [Risks Related to Dependence on Third Parties and Government Contracts](index=54&type=section&id=Risks%20Related%20to%20Dependence%20on%20Third%20Parties%20and%20Government%20Contracts) - The company relies entirely on third-party contract research organizations (CROs) to conduct all nonclinical studies and clinical trials, limiting control over these critical activities[318](index=318&type=chunk) - Manufacturing of all product candidates is outsourced to a small number of third-party contract manufacturers (CMOs), primarily in Asia, creating supply chain, quality control, and geopolitical risks[323](index=323&type=chunk)[324](index=324&type=chunk)[325](index=325&type=chunk) - Government contracts, such as the BARDA award, are subject to unilateral termination or modification by the government and may grant the government 'march-in' rights to intellectual property developed with federal funds[336](index=336&type=chunk)[341](index=341&type=chunk)[348](index=348&type=chunk) [Risks Related to Regulatory and Legal Compliance](index=63&type=section&id=Risks%20Related%20to%20Regulatory%20and%20Legal%20Compliance) - The company must navigate a complex, lengthy, and unpredictable regulatory approval process with the FDA and foreign authorities, where failure to obtain approval will prevent commercialization[369](index=369&type=chunk)[371](index=371&type=chunk) - Special designations like Fast Track (for tebipenem HBr and SPR720) and Priority Review (for tebipenem HBr) do not guarantee or necessarily lead to a faster approval process[378](index=378&type=chunk)[379](index=379&type=chunk) - Even if approved, products will be subject to extensive ongoing regulatory requirements, including for manufacturing (cGMPs), labeling, promotion, and potentially costly post-marketing studies or Risk Evaluation and Mitigation Strategies (REMS)[387](index=387&type=chunk)[388](index=388&type=chunk)

Spero Therapeutics, Inc. (NASDAQ:SPRO) Q4 2021 Earnings Conference Call March 31, 2022 4:30 PM ET Company Participants Ted Jenkins - VP, Head of IR Ankit Mahadevia - CEO David Melnick - Chief Medical Officer Cristina Larkin - COO Sath Shukla - CFO Conference Call Participants Louise Chen - Cantor Ritu Baral - Cowen Esther Hong - Berenberg Kevin DeGeeter - Oppenheimer Operator Good afternoon, and welcome to the Spero Therapeutics Fourth Quarter and Year-End 2021 Financial Results Conference Call. [Operator I ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____to____ Commission file number 001-38266 SPERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Delaware | | 46-4590683 | | --- | --- ...

Spero Therapeutics, Inc. (NASDAQ:SPRO) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Ted Jenkins - Vice President, Head of Investor Relations Ankit Mahadevia - Chief Executive Officer David Melnick - Chief Medical Officer Cristina Larkin - Chief Operating Officer Sath Shukla - Chief Financial Officer Conference Call Participants Ritu Baral - Cowen Louise Chen - Cantor Fitzgerald & Co. Ram Selvaraju - H.C. Wainwright Esther Hong - Berenberg Operator Good afternoon, and we ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38266 SPERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 ( State or other jurisdiction of inco ...

Spero Therapeutics Announces Second Quarter 2021 Operating Results and Provides Business Update August 5, 2021 Tebipenem HBr on track for NDA submission in the fourth quarter of 2021 Announced $40 million equity investment from Pfizer Inc. and licensing agreement for SPR206 Initiated Phase 1 bronchoalveolar lavage and renal impairment clinical trials of SPR206 Conference call and live webcast at 4:30 p.m. ET today CAMBRIDGE, Mass., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a ...

Spero Therapeutics, Inc. (NASDAQ:SPRO) Q2 2021 Earnings Conference Call August 5, 2021 4:30 PM ET Company Participants Ted Jenkins - VP, IR Ankit Mahadevia - Co-Founder, CEO, President & Director David Melnick - Chief Medical Officer Cristina Larkin - COO Satyavrat Shukla - CFO Conference Call Participants Lyla Youssef - Cowen and Company Louise Chen - Cantor Fitzgerald & Co. Kevin DeGeeter - Oppenheimer Esther Hong - Berenberg Raghuram Selvaraju - H.C. Wainwright & Co. Operator Good day, everyone, and than ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38266 SPERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) ( State or other jurisdiction of incorpora ...

Ladenburg Thalmann Healthcare Conference July 13, 2021 Forward-looking Statements 2 This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, the design, initiation, timing and submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for tebipenem HBr and the potential approval of tebipenem HBr by the FDA; future commercialization, the potential number of patients who could be treat ...