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SPRO on Nasdaq

Spero Therapeutics, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need. We do not have any products approved for sale and have not generated any revenue from product sales. Our clinical-stage product candidate, tebipenem HBr, has completed a second Phase 3 trial, and has the potential to be the first oral carbapenem to treat adult patients with complicated urinary tract infections, including pyelonephritis, caused by certain microorganisms.”4 It is headquartered in Cambridge, United States.2 Its shares trade on Nasdaq under the symbol SPRO.2

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Last updated Oct 21, 2026.

Overview

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  • TickerSPRO on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersCambridge, United States2
  • Incorporated inDE3
  • Business address675 Massachusetts Avenue, 14Th Floor, Cambridge, Ma 021393
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI54930074G13LHWJT23232
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 54482872

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We are a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need. Since our inception in 2013, we have focused 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 revenue from product sales.4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

50.2%Operating margin5
68.1%Net margin5
3292.5%Revenue growth, 20255
14.5%Return on equity5

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Collaboration Revenue Related Party brought in 70% of the revenue Spero Therapeutics, Inc. broke down this way in fiscal 2025.

  1. Collaboration Revenue Related Party$47.0M570%up 74% from 2024
  2. Collaboration Revenue$12.6M519%up 3292% from 2024
  3. Grant revenue$7.2M511%down 65% from 2024
Products and services by year
Products and services20242025
Collaboration Revenue Related Party$27.0M$47.0M
Collaboration Revenue$371.0K$12.6M
Grant revenue$20.6M$7.2M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development81¢$38.5M
  • Income tax1¢$261.0K
  • Profit18¢$8.6M

Out of $12.6M in revenue.5

Financial statements

Revenue6789105$12.6M in 2025+165% since 2019
0$5.0M$10.0M$15.0M2019: $4.7M$4.7M20192020: $258.0K$258.0K2020−95%2021: $3.1M$3.1M2021+1090%2022: $2.5M$2.5M2022−18%2023: $933.0K$933.0K2023−63%2024: $371.0K$371.0K2024−60%2025: $12.6M$12.6M2025+3292%
Operating income6789105$6.3M in 2025
-$100.0M-$50.0M0$50.0M2019: -$63.2M-$63.2M20192020: -$79.1M-$79.1M2020+25%2021: -$88.0M-$88.0M2021+11%2022: -$42.2M-$42.2M2022−52%2023: $21.5M$21.5M20232024: -$73.4M-$73.4M20242025: $6.3M$6.3M2025
Net income679105$8.6M in 2025
-$100.0M-$50.0M0$50.0M2019: -$60.9M-$60.9M20192020: -$78.3M-$78.3M2020+29%2021: -$89.8M-$89.8M2021+15%2022: -$46.4M-$46.4M2022−48%2023: $22.8M$22.8M20232024: -$68.6M-$68.6M20242025: $8.6M$8.6M2025

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Grant revenue$7.2M$20.6M
Collaboration revenue - related party$47.0M$27.0M
Collaboration revenue$12.6M$371.0K
Total revenues$66.8M$48.0M
Research and development$38.5M$96.8M
General and administrative$21.2M$23.7M
Impairment of long-term asset$587.0K$0
Restructuring$258.0K$877.0K
Total operating expenses$60.5M$121.3M
Income (loss) from operations$6.3M-$73.4M
Interest income$2.5M$4.7M
Other income (expense), net$7.0K$60.0K
Total other income, net$2.5M$4.8M
Net income (loss) before income taxes$8.8M-$68.6M
Income tax expense-$261.0K$0
Net income (loss) and comprehensive income (loss)$8.6M-$68.6M
Net income (loss) per share attributable to common stockholders, basic$0.15-$1.27
Net income (loss) per share attributable to common stockholders, diluted$0.15-$1.27
Weighted average common shares outstanding, basic:56.0M shares54.0M shares
Weighted average common shares outstanding, diluted:59.0M shares54.0M shares

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Corporate structure

Spero Therapeutics, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Spero Therapeutics, Inc.

  • Anson Funds Management LP Filed SCHEDULE 13G/A on Spero Therapeutics, Inc., latest Aug 14, 2025 (3 filings since Feb 14, 2024)
  • GSK Filed SCHEDULE 13D/A on Spero Therapeutics, Inc., latest Mar 28, 2025 (3 filings since Nov 14, 2022)
  • Aquilo Capital Management, LLC Filed SC 13G/A on Spero Therapeutics, Inc., latest Feb 14, 2023 (4 filings since Feb 14, 2022)
  • BIOTECHNOLOGY VALUE FUND L P Filed SC 13G/A on Spero Therapeutics, Inc., latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • BlackRock Filed SC 13G on Spero Therapeutics, Inc., latest Jul 8, 2022 (2 filings since Feb 3, 2022)
  • Atlas Venture Fund IX, L.P. Filed SC 13G/A on Spero Therapeutics, Inc., latest Jan 25, 2022
  • Spero Therapeutics, Inc. Cambridge, Massachusetts, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Spero Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$3.6M10 Dec 31, 2024$3.6M10 Dec 31, 20230%
Accumulated depreciation$3.6M10 Dec 31, 2024$3.6M10 Dec 31, 2023+0.1%
Property and equipment, net$010 Dec 31, 2024$2.0K10 Dec 31, 2023−100.0%
Operating-lease assets (leased space)$1.5M5 Dec 31, 2025$3.1M5 Dec 31, 2024−52.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$40.3M5 Dec 31, 2025$52.9M5 Dec 31, 2024−23.9%

Properties, in its own words

Our headquarters are located in Cambridge, Massachusetts, where we lease approximately 23,400 square feet of office space. Our lease extends through July 2027. In September 2025, we entered into sublease agreements for a portion of our lease through the remainder of its lease term. We believe that our existing facilities will be sufficient to meet our current needs.

Item 2 of the 10-K filed Mar 26, 2026.4

Leadership

Who has led Spero Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Sath Shukla2023–now

President

  1. Sath Shukla2023–now

Chief financial officer

  1. Joel Sendek2017–2019
  2. Stephen J. Dipalma2019
  3. Sath Shukla2021–2023
  4. Esther Rajavelu2024–now

Chief operating officer

  1. Cristina Larkin2017–2022
  2. Timothy Keutzer2023–now
20202025
Board members and other officers (21)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorAnkit Mahadevia named Nov 15, 202240
  • Executive OfficerSatyavrat Shukla named Nov 15, 202240

Former names

  • Spero Therapeutics, LLCMar 21, 2017 to Mar 21, 20173

Timeline

  1. Aug 28, 20268-K Entered a material agreement; Other events41
  2. Aug 12, 20268-K Results of operations42
  3. Jul 14, 20268-K Entered a material agreement; New debt or obligation; Regulation FD disclosure43
  4. Jun 25, 20268-K Executive or director change; Bylaws or fiscal year changed; Shareholder vote44
  5. Jun 22, 20268-K Regulation FD disclosure; Other events45
  6. May 13, 20268-K Results of operations46
  7. Mar 26, 20268-K Results of operations47
  8. Jan 30, 20268-K Executive or director change; Other events48
  9. Dec 19, 20258-K Other events49
  10. Nov 13, 20258-K Results of operations; Regulation FD disclosure50
  11. Aug 12, 20258-K Results of operations; Regulation FD disclosure51
  12. Jun 18, 20258-K Executive or director change; Shareholder vote52
  13. Aug 3, 2023New chief executive Sath Shukla becomes CEO13
  14. Dec 12, 2013Founded Spero Therapeutics, Inc. is founded2

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.13) a share, on Nov 13, 2025.53

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results42
  2. May 13, 2026Reported quarterly or annual results46
  3. Mar 26, 2026Reported quarterly or annual results47
  4. Nov 13, 2025Reported quarterly or annual results50
  5. Aug 12, 2025Reported quarterly or annual results51
  6. May 13, 2025Reported quarterly or annual results54
  7. Mar 27, 2025Reported quarterly or annual results55
  8. Jan 10, 2025Reported quarterly or annual results56

Drug trials and FDA: recently

  1. Jan 27, 2025Phase 3 trial completed Phase 3 trial of TBP-PI-HBr, Imipenem-cilastatin and others in Urinary Tract Infection: primary completion Jan 27, 2025, results posted Mar 10, 2026 (ClinicalTrials.gov NCT06059846).57

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

243 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 61 major events, 112 insider forms, 15 large holders, 1 private raises, 34 other. The latest 20:

  1. Sep 10, 2026EFFECT EDGAR
  2. Aug 28, 20268-K EDGAR
  3. Aug 28, 2026S-3 EDGAR
  4. Aug 12, 20268-K EDGAR
  5. Aug 12, 202610-Q EDGAR
  6. Aug 6, 20264 EDGAR
  7. Aug 6, 20263 EDGAR
  8. Jul 14, 20268-K EDGAR
  9. Jun 25, 20264 EDGAR
  10. Jun 25, 20264 EDGAR
  11. Jun 25, 20264 EDGAR
  12. Jun 25, 20264 EDGAR
  13. Jun 25, 20264 EDGAR
  14. Jun 25, 20264 EDGAR
  15. Jun 25, 20264 EDGAR
  16. Jun 25, 20268-K EDGAR
  17. Jun 23, 2026S-8 EDGAR
  18. Jun 22, 20268-K EDGAR
  19. May 13, 202610-Q EDGAR
  20. May 13, 20268-K EDGAR

The 243 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

53 open-market trades by officers, directors and large owners since October 2021: 13 buys and 40 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 4, 2026Rajavelu EstherSee RemarksSale25,240$2.51$63.4KForm 4
Feb 6, 2026Rajavelu EstherSee RemarksSale87,917$2.36$207.5KForm 4
Feb 6, 2026Keutzer TimothyChief Operating OfficerSale18,652$2.36$44.0KForm 4
Feb 4, 2026Keutzer TimothyChief Operating OfficerSale3,471$2.24$7.8KForm 4
Feb 3, 2026Keutzer TimothyChief Operating OfficerSale24,224$2.14$51.8KForm 4
Feb 2, 2026Keutzer TimothyChief Operating OfficerSale18,891$2.20$41.6KForm 4
Feb 2, 2026Rajavelu EstherSee RemarksSale18,442$2.20$40.6KForm 4
Nov 7, 2025Rajavelu EstherSee RemarksSale40,270$2.37$95.4KForm 4
Aug 28, 2025Mahadevia AnkitDirectorSale6,572$1.97$12.9KForm 4
Aug 28, 2025Keutzer TimothyChief Operating OfficerSale1,695$1.97$3.3KForm 4
Feb 5, 2025Keutzer TimothyChief Operating OfficerSale56,537$0.78$44.1KForm 4
Feb 5, 2025Rajavelu EstherSee RemarksSale20,689$0.78$16.1KForm 4
Feb 5, 2025Shukla SathCEO & PresidentSale155,333$0.78$121.2KForm 4
Feb 5, 2025Mahadevia AnkitDirectorSale69,219$0.78$54.0KForm 4
Nov 8, 2024Rajavelu EstherSee RemarksSale17,245$1.30$22.4KForm 4
Nov 7, 2024Rajavelu EstherSee RemarksSale23,351$1.31$30.6KForm 4
Aug 27, 2024Mahadevia AnkitDirectorSale5,912$1.35$8.0KForm 4
Aug 27, 2024Keutzer TimothyChief Operating OfficerSale2,213$1.35$3.0KForm 4
Aug 27, 2024Shukla SathCEO & PresidentSale2,757$1.35$3.7KForm 4
Aug 5, 2024Shukla SathCEO & PresidentSale17,641$1.31$23.1KForm 4

All 53 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Esther Rajavelu47$577.2K$2.1M64
2025Satyavrat Shukla$244.2K$2.0M64
2025Tim Keutzer$484.6K$1.4M64
2024Former President and Chief Executive Officer$603.8K$2.0M64
2024Chief Operating Officer$475.1K$1.0M64
2024President and Chief Executive OfficerChief Financial Officer, Chief Business Officer and Treasurer$483.3K$856.5K64

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$75.9M 2018–2025
Money received by yearMoney received by year, 2018–2025: $75.9M in all. Private raises (Form D) $9.0M; Federal grants $5.9M; Federal contracts $61.0M.$0$10M$20M$30M2018 · Federal contracts: $16.2M20182019 · Federal grants: $5.9M2019 · Federal contracts: $2.7M20202021 · Federal contracts: $2.1M2022 · Private raises (Form D): $9.0M2022 · Federal contracts: $17.0M20222023 · Federal contracts: $1.5M2024 · Federal contracts: $15.1M20242025 · Federal contracts: $6.4M2025
Without federal contracts$14.9M 2019–2022
Without federal contractsWithout federal contracts, 2019–2022: $14.9M in all. Private raises (Form D) $9.0M; Federal grants $5.9M.$0$2.5M$5M$7.5M$10M2019 · Federal grants: $5.9M2019202020212022 · Private raises (Form D): $9.0M2022
Figures by year
YearPrivate raises (Form D)Federal grantsFederal contractsTotal
2025––$6.4M$6.4M
2024––$15.1M$15.1M
2023––$1.5M$1.5M
2022$9.0M–$17.0M$26.0M
2021––$2.1M$2.1M
2019–$5.9M$2.7M$8.6M
2018––$16.2M$16.2M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Nov 7, 2022Raised $9 million in a private offering of equity40 Form D: 1 investor so far Form D

Federal awards

Obligated amounts from USAspending.gov65, by calendar year, 2018–2025, for its registration. Obligations are what agencies committed, not always what was paid out. Contracts pay for goods and services; grants, loans and direct payments are assistance. Loans are charted at the face value of the loans listed here. An award’s amount below is its lifetime total, and some began before the years charted.

Largest grants

  1. Jul 15, 2019$5.9M from Defense Health Agency: Military Medical Research And Development66 To SPERO THERAPEUTICS, INC. Award W81XWH1910295

Largest contracts

  1. Jul 12, 2018$49.2M from Office of Assistant Secretary for Preparedness and Response: Igf::ot::igf67 To SPERO THERAPEUTICS, INC. Award 75A50118C00015
  2. May 17, 2021$10.5M from National Institutes of Health: To advance clinical and non-clinical development of an antibiotic candidate.68 To SPERO THERAPEUTICS, INC. Award 75N93021C00022
  3. Jun 30, 2015$5.9M from National Institutes of Health: Igf::ot::igf - "development of a second generation polymyxin for therapy of mdr gram-negative infections"69 To SPERO THERAPEUTICS, INC. Award HHSN272201500014C

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 60. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
GSK plc9,190,606$20.3M3.4%No change
Pfizer Inc2,362,348$5.3M3.1%No change
Vanguard Capital Management LLC2,036,226$4.5M0.0%+236,346
Renaissance Technologies LLC947,904$2.1M0.0%−241,331
Alphabet Inc.889,979$2.0M0.0%No change
Susquehanna International Group, Llp759,290$1.7M0.0%+426,175
BlackRock, Inc.594,404$1.3M0.0%+161,202
Geode Capital Management, LLC566,329$1.3M0.0%+46,407
Raymond James Financial Inc521,705$1.2M0.0%New
Two Sigma Investments, LP382,814$846.0K0.0%−502,817
Arrowstreet Capital, Limited Partnership332,970$735.9K0.0%New
Vanguard Fiduciary Trust Co287,648$635.7K0.0%+23,533
Dimensional Fund Advisors LP274,820$607.6K0.0%+245,052
Goldman Sachs Group Inc256,985$567.9K0.0%New
State Street Corp214,751$474.6K0.0%No change
Jane Street Group, LLC158,097$349.4K0.0%+51,752
UBS Group AG139,680$308.7K0.0%+136,671
Bridgeway Capital Management, LLC114,800$253.7K0.0%No change
Northern Trust Corp108,274$239.3K0.0%−12,710
Point72 Asset Management, L.P.104,377$230.7K0.0%+44,709
Ionic Capital Management LLC102,698$227.0K0.2%−93,241
Federation des caisses Desjardins du Quebec91,900$202.2K0.0%New
Shay Capital LLC72,391$160.0K0.0%+2,037
Invesco Ltd.64,245$142.0K0.0%+18,871
Simplex Trading, LLC61,312$135.5K0.0%+31,008

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Spero Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARSpero Therapeutics, Inc.1
  • CIK0001701108
  • Employer ID (EIN)46-45906834
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address675 Massachusetts Avenue, 14Th Floor, Cambridge, MA 021391
  • Phone857-242-16001
  • Shares outstanding58,234,827 as of Aug 7, 202612
  • Public float$160.3M as of Jun 30, 20254
  • AuditorPricewaterhouseCoopers LLP, Boston, Massachusetts PCAOB ID 238; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceMar 21, 20171
  • Filings513 in all: 4 (197), 8-K (115), 3 (31), 10-Q (27), SC 13G/A (23), S-8 (16), SC 13G (11), 10-K (9)1
    All 34 form types

    DEF 14A (9), SC 13D/A (9), CORRESP (6), EFFECT (6), 424B5 (5), CT ORDER (5), ARS (4), DEFA14A (4), S-3 (4), 8-K/A (3), D (3), PRE 14A (3), UPLOAD (3), 144 (2), 424B4 (2), DRS (2), DRS/A (2), S-1 (2), S-1/A (2), SC 13D (2), 10-K/A (1), 8-A12B (1), CERTNAS (1), DRSLTR (1), SCHEDULE 13D/A (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 26, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Aug 28, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per shareSPROThe Nasdaq Global Select Market

From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Spero Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 26, 2026: 65 risks under these headings, as written.4

  • Risks Related to Product Development and Commercialization
  • Our ability to realize the value of tebipenem HBr depends on obtaining FDA approval. Even if such approval is obtained, the timeline of, and any requirements imposed as part of, such approval may impact the attractiveness of commercialization of tebipenem HBr through our partnership with GSK.
  • If our clinical trials fail to produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of any existing and future product candidates.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, clinical development activities could be delayed or otherwise adversely affected.
  • Analyses of preliminary or interim data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Serious adverse events or undesirable side effects or other unexpected properties of any product candidates may be identified during development or after approval that could delay, prevent or cause the withdrawal of regulatory approval, limit the commercial potential, or result in significant negative consequences following marketing approval.
  • Even if a product candidate does obtain regulatory approval, it may never achieve the market acceptance by physicians, patients, hospitals, third-party payors and others in the medical community that is necessary for commercial success and the market opportunity may be smaller than we estimate.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • If we or our collaborators are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing any product candidates if such product candidates are approved.
  • If we engage in future acquisitions or strategic collaborations, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.
  • We face substantial competition from other pharmaceutical and biotechnology companies and our operating results may suffer if we fail to compete effectively.
  • Even if we or our partners are able to commercialize our existing or future product candidates, the product may become subject to unfavorable pricing regulations, or third-party payor coverage and reimbursement policies that could harm our business.
The other 54 risks
  • We cannot predict whether bacteria may develop resistance to our product candidate, if approved, which could affect its revenue potential.
  • If we are not successful in developing and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.
  • Product liability lawsuits against us could divert our resources, cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.
  • Our internal computer systems, or those of our contract research organizations or other contractors or consultants, may fail or suffer cybersecurity incidents, which could result in a material disruption of our product development programs, and could subject us to liability.
  • Our actual or perceived failure to comply with data protection laws and regulations could lead to government enforcement actions, private litigation and/or adverse publicity and could negatively affect our business.
  • We or third parties upon whom we depend may be adversely affected by natural disasters and/or health epidemics, and our business, financial condition and results of operations could be adversely affected.
  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have not generated any revenue from the sale of our products, have a history of losses and expect to incur future losses. If we are unable to obtain additional capital, we may not be able to continue our operations on the scope or scale as currently conducted, and that could have a material adverse effect on our business, results of operations and financial condition.
  • We expect to continue to incur significant expenses and operating losses for the foreseeable future. If we are unable to achieve commercialization, revenue from product sales, and, ultimately, profitability, the market value of our common stock will likely decline.
  • If we are unable to raise capital when needed, or do not receive payments from our collaboration partnership agreements, it could limit our ability to support our operations.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to any of our technologies or product candidates.
  • We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability.
  • Our ability to use our net operating loss carryforwards may be limited.
  • Risks Related to Our Dependence on Third Parties
  • We may not achieve the milestones triggering payments to us in our existing, or any future, license and collaboration agreements with third parties.
  • We may have to alter our development and commercialization plans if we are not able to establish collaborations.
  • We rely on third parties to conduct all of our nonclinical studies and all of our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize any product candidates. If they do not perform satisfactorily, our business may be materially harmed.
  • We contracted with third parties for the manufacture of clinical supplies of tebipenem HBr and expect to continue to do so in connection with any future clinical trials and commercialization of any potential product candidates. This reliance on third parties increases the risk that we will not have sufficient quantities of our existing and future product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • If we fail to comply with our obligations in the agreements under which we in-license or acquire development or commercialization rights to products, technology or data from or to third parties, we could lose such rights that are important to our business.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain sufficient patent protection for our technology or our existing or future product candidates, or if the scope of the patent protection is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and product candidates may be adversely affected.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
  • If we are sued for infringing intellectual property rights of third parties, or otherwise become involved in disputes regarding our intellectual property rights, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our existing or future product candidates.
  • We may be subject to claims that we or our employees, consultants or contractors have misappropriated the intellectual property of a third party, or claims asserting ownership of what we regard as our own intellectual property.
  • If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.
  • We have registered trademarks and pending trademark applications. Failure to enforce our registered marks or secure registration of our pending trademark applications could adversely affect our business.
  • Risks Related to Regulatory Approval and Other Legal Compliance Matters
  • If we or our collaboration partners are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our existing and future product candidates, and our ability to generate revenue will be materially impaired.
  • A fast track designation may not actually lead to a faster development or regulatory review or approval process.
  • Priority review designation by the FDA may not lead to a faster regulatory review or approval process and, in any event, does not assure FDA approval.
  • While we negotiated a SPA agreement with the FDA relating to our pivotal Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including acute pyelonephritis, this agreement does not guarantee approval of tebipenem HBr or any other particular outcome from regulatory review of the clinical trial or the product candidate.
  • We may seek orphan drug designation for one or more of our future product candidates. We may not be able to obtain or maintain orphan drug designations for any product candidates, and we may be unable to take advantage of the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • If approved for commercial marketing in the United States, our existing or future product candidates may face generic competition sooner than anticipated.
  • If we or our partners are unable to obtain marketing approval in international jurisdictions, we will not be able to market our existing or future product candidates abroad.
  • If we receive regulatory approval for any product candidates, we will be subject to ongoing obligations and continuing regulatory review, which may result in significant additional expense. Our existing or future product candidates, if approved, could be subject to restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our existing or future product candidates, when and if approved.
  • Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Recently enacted and future policies and legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize any of our product candidates and may affect the reimbursement made for any product candidate for which we receive marketing approval.
  • Changes in tax laws or in their implementation or interpretation could adversely affect our business and financial condition.
  • If we successfully commercialize one of our product candidates, failure to comply with our reporting and payment obligations under U.S. governmental pricing programs could have a material adverse effect on our business, financial condition and results of operations.
  • Our employees, independent contractors, principal investigators, contract research organizations, consultants or vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program and develop and secure approval of any of our product candidates in a timely manner, which would negatively impact our business.
  • Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact our business and operating results.
  • Risks Related to Employee Matters and Managing Growth
  • Our future success depends on our ability to retain our key executives and to attract, retain and motivate qualified personnel.
  • We undertook internal restructuring activities that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition.
  • If foreign approvals are obtained, we will be subject to additional risks in conducting business in international markets.
  • Risks Related to Our Common Stock
  • The price of our common stock has been and, in the future, may continue to be volatile whether related or unrelated to our operations, which could result in a decline in value for our stockholders.
  • An active trading market for our common stock may not be sustained.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.
  • Unstable global economic and political conditions, including economic uncertainty tied to volatility in interest rates and inflation, credit and financial market instability, and uncertainty related to ongoing geopolitical conflicts, could adversely affect our business, financial condition, stock price and ability to raise capital.
  • We have broad discretion in the use of our cash reserves and may not use them effectively.
  • We are a smaller reporting company and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance initiatives and corporate governance practices.
  • Failure to maintain effective internal controls in accordance with Section 404 of Sarbanes-Oxley in the future could have a material adverse effect on our ability to produce accurate financial statements and on our stock price.
  • A significant portion of our total outstanding shares may be sold into the market at any time, which could cause the market price of our common stock to decline significantly, even if our business is doing well.
  • We do not anticipate paying any cash dividends on our capital stock in the foreseeable future. Accordingly, stockholders must rely on capital appreciation, if any, for any return on their investment.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • We may become involved in securities litigation that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages.

Legal proceedings

Securities Class Action Lawsuits and Derivative Actions

Two putative class action lawsuits were filed against the Company and certain of its current and former officers in the United States District Court for the Eastern District of New York, one captioned Richard S. Germond v. Spero Therapeutics, Inc., Ankit Mahadevia, and Satyavrat Shukla, Case No. 1:22-cv-03125, filed on May 26, 2022, and the other captioned Kashif Memon v. Spero Therapeutics, Inc., Ankit Mahadevia, and Satyavrat Shukla Case No. 1:22-cv-04154, filed on July 15, 2022. The parties moved to consolidate the two complaints on July 22, 2022, which were ordered consolidated on August 5, 2022 (“Consolidated Putative Class Action”). The parties filed an Amended Complaint on December 5, 2022, purported to be brought on behalf of stockholders who purchased our common stock from September 8, 2020 through May 2, 2022. The Amended Complaint generally alleges that the Company and certain of its current and former officers violated Sections 10(b) and/or 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the NDA for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA. Plaintiffs seek unspecified damages, interest, attorneys’ fees, and other costs. The Company filed a fully-briefed Motion to Dismiss on June 21, 2023. By Order entered on September 30, 2024, the Motion to Dismiss was granted, dismissing the Amended Complaint in its entirety. The Court ordered the case to be closed by Memorandum and Order entered on October 28, 2024.

The opening of Item 3, Legal Proceedings.4

Sources

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