Spero Therapeutics Announces Second Quarter 2026 Operating Results and Provides Business Update
Rhea-AI Summary
Spero Therapeutics (Nasdaq: SPRO) reported second quarter 2026 results and major strategic milestones. Net loss was $9.6 million (vs. $1.7 million in Q2 2025), or $0.16 per diluted share. Total revenue was $0 compared with $14.2 million a year earlier, as prior collaboration and grant revenue was fully recognized in earlier periods.
Research and development expenses fell to $3.4 million from $10.7 million, mainly due to reduced Utebzi Phase 3 costs, while general and administrative expenses increased to $6.5 million from $5.9 million. Cash and cash equivalents were $50.8 million at June 30, 2026, excluding proceeds from a subsequent royalty financing.
Operationally, the FDA approved Utebzi, the first and only oral carbapenem for certain adult cUTI patients, with GSK holding U.S. and European commercialization rights. Spero also entered an exclusive license with Innovent Biologics for SP001 outside Greater China, closed a $105 million non-recourse, non-dilutive royalty financing backed by a portion of future Utebzi proceeds, and appointed Debra Jeske Zack, M.D., Ph.D., as Chief Medical Officer. The company expects its June 30 cash plus financing proceeds to fund operations into the second half of 2029.
Positive
- FDA approval of Utebzi as first and only oral carbapenem for certain adult cUTI patients
- Closed non-recourse, non-dilutive royalty financing for $105 million in gross proceeds
- Cash plus royalty financing expected to fund operations into second half of 2029
- Exclusive global (ex-Greater China) license for Phase 2-ready anti-CD40L antibody SP001
- R&D expenses decreased to $3.4 million from $10.7 million year over year in Q2
- Company may retain 35% interest in GSK Utebzi proceeds after NPA payments
Negative
- Q2 2026 revenue was $0 versus $14.2 million in Q2 2025
- Net loss widened to $9.6 million from $1.7 million year over year in Q2
- General and administrative expenses rose to $6.5 million from $5.9 million
- Total stockholders' equity declined to $44.2 million from $59.0 million since year-end 2025
News Explained
Future GSK proceeds will repay the royalty financing, while Spero retains 35% after required payments rather than issuing stated equity.
The SP001 license entered in
The financing is generally payable solely from those GSK proceeds, and Spero may retain
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 13 | Q1 earnings report | Positive | +13.1% | Lower net loss and continued FDA review of tebipenem HBr |
| Mar 26 | Q4 earnings report | Positive | -1.7% | Reported quarterly and annual net income alongside NDA resubmission |
| Nov 13 | Q3 earnings report | Negative | -1.2% | Program discontinuation and lower revenue offset positive Phase 3 data |
| Aug 12 | Q2 earnings report | Positive | -18.0% | PIVOT-PO trial stopped early after meeting efficacy endpoints |
| May 13 | Q1 earnings report | Negative | -5.8% | Higher net loss and lower revenue during Phase 3 development |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-specific earnings events averaged -2.72%, with the latest Q1 2026 report followed by a positive reaction while earlier listed events were negative.
Key Terms
exclusive license agreement financial
monoclonal antibody medical
non-recourse financial
non-dilutive financial
royalty financing financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Entered an exclusive license agreement with Innovent Biologics for SP001, a Phase 2-ready, third-generation anti-CD40L antibody for immune-mediated diseases
- U.S. Food and Drug Administration approved Utebzi™ (tebipenem pivoxil), the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections (cUTIs), including pyelonephritis
- Closed
$105 million non-recourse, non-dilutive financing backed by a portion of future Utebzi milestones and royalties, extending cash runway into the second half of 2029 - Appointed Debra Zack, M.D., Ph.D., as Chief Medical Officer
- Conference call today at 5pm EDT
CAMBRIDGE, Mass., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on advancing next-generation medicines in immunology and inflammation, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update.
"During the second quarter, we achieved several defining milestones that have fundamentally strengthened Spero's business. We entered the quarter as a company preparing for an important regulatory milestone and have since then announced the FDA approval of Utebzi; a new Phase 2-ready immunology program with SP001; and financing that positions us to continue executing on our mission to deliver transformative therapies to patients,” said Esther Rajavelu, President and Chief Executive Officer of Spero. "As we look to the remainder of 2026, our priorities are to advance SP001 toward a Phase 2 study in IgG4-related disease and continue evaluating additional development opportunities in immune-mediated diseases to expand the SP001 value proposition, while maintaining our disciplined approach to execution.”
Recent Business Highlights
Exclusive License Agreement with Innovent Biologics for SP001
- In July 2026, Spero entered into an exclusive license agreement with Innovent Biologics, Inc. for SP001. Spero gained exclusive rights to develop, research, manufacture, and commercialize SP001 worldwide, excluding Greater China (Mainland China, Hong Kong, Macau, and Taiwan), where Innovent retains rights.
- SP001 is a third-generation, fully humanized, Fc-silent IgG1 monoclonal antibody targeting CD40L, an upstream immune activation signal involved in T-cell, B-cell, antigen-presenting cell, and platelet biology. Innovent completed two healthy volunteer Phase 1 trials, a single ascending dose (“SAD”) study and a multiple ascending dose (“MAD”) study, as well as a Phase 1b MAD study in patients with primary Sjögren’s disease (“SjD”). Data from the Phase 1b SjD study were presented in a poster session at the EULAR 2026 Congress.
- Spero plans to advance SP001 into a Phase 2 study in IgG4-related disease (IgG4-RD), a serious, rare chronic fibroinflammatory disease with significant treatment burden and limited therapeutic options.
Utebzi (tebipenem pivoxil) U.S. FDA Approval
- In June 2026, Spero and GSK announced that the U.S. Food and Drug Administration (FDA) approved Utebzi for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain susceptible pathogens in adult patients who have limited or no alternative oral treatment options. Utebzi is the first and only oral carbapenem antibiotic approved for these patients. The product is expected to be made available by GSK to U.S. patients by the end of 2026. GSK holds commercialization rights in the U.S. and Europe.
- In July 2026, Spero announced a non-recourse, non-dilutive royalty financing with affiliates of HealthCare Royalty Partners, a business of KKR (HCRx), for
$105 million in gross proceeds, in exchange for rights to a portion of the anticipated payments from sales of Utebzi owing from GSK (GSK Proceeds). - The transaction is structured as a non-recourse Note Purchase and Guaranty Agreement (NPA) generally payable solely from the GSK proceeds, and a Royalty and Milestone Payment Interest Purchase and Sale Agreement (RPA) under which the Company may retain
35% interest in the GSK Proceeds arising after required payments under the NPA, preserving potential long-term upside from the asset. - The proceeds will primarily support advancement of SP001.
Corporate
- In July 2026, Spero announced the appointment of Debra Jeske Zack, M.D., Ph.D., as Chief Medical Officer. Dr. Zack is a board-certified rheumatologist with a Ph.D. in immunology and brings more than 25 years of leadership in developing therapeutics for immune-mediated diseases. She will oversee Spero's clinical development strategy and organization as the Company advances its immunology program.
Second Quarter 2026 Financial Results
- Spero reported a net loss of
$9.6 million for the second quarter of 2026 compared to a net loss of$1.7 million for the second quarter of 2025, or a diluted net loss per share of common stock of$0.16 and$0.03 , respectively. - No revenue was recognized for the second quarter of 2026, compared to total revenue of
$14.2 million for the second quarter of 2025, as all deferred revenue under the collaboration agreements was recognized in prior periods and all grant revenue has been fully recognized, and the awards have been completed and closed out. - Research and development expenses for the second quarter of 2026 were
$3.4 million , compared to$10.7 million of research and development expenses for the same period in 2025. The decrease in research and development expenses was a result of decreased clinical activities related to our pivotal Phase 3 clinical trial of Utebzi, which was stopped early for efficacy in the first half of 2025, and a decrease in personnel related costs. - General and administrative expenses for the second quarter of 2026 were
$6.5 million , compared to$5.9 million of general and administrative expenses for the same period in 2025. The increase was a result of increased legal and business development costs, offset partially by a decrease in personnel related costs. - As of June 30, 2026, cash and cash equivalents were
$50.8 million . This balance does not reflect the proceeds from the royalty financing completed in July 2026. - The company expects that its cash and cash equivalents at June 30, 2026, together with the proceeds of the royalty financing, will be sufficient to fund operating expenses and capital expenditure into the second half of 2029.
For further details on Spero’s financials, refer to Spero’s Quarterly Report on Form 10-Q, filed with the U.S. Securities and Exchange Commission (SEC) today.
Conference call and webcast
Management will host a conference call and live audio webcast at 5:00 pm EDT today, August 12, to discuss the results and provide a business and pipeline update. To access the call, please dial 1-877-407-0789 (domestic) or 1-201-689-8562 (international) and refer to conference ID 13762082, or click on this link to request a return call. The webcast for the event can be accessed live on this link, or on the Investor Relations page of the Spero Corporate website at https://www.sperotx.com/. The archived webcast will be available for 30 days following the call.
About SP001
SP001 is a third-generation, potential best-in-class, fully humanized, Fc-silent IgG1 monoclonal antibody targeting CD40L, an upstream immune activation signal involved in T-cell, B-cell, antigen-presenting cell, and platelet biology. By blocking CD40L, SP001 has the potential to provide a targeted non-B-cell-depleting treatment across multiple immune-mediated diseases where immune-cell interactions drive chronic inflammation, relapse, and tissue damage. SP001 is designed to address platelet activation concerns associated with earlier anti-CD40L antibodies, while preserving key monoclonal antibody properties, including FcRn interaction that supports IgG-like half-life.
About Spero Therapeutics
Spero Therapeutics is a clinical-stage biopharmaceutical company focused on advancing next-generation medicines for patients with serious immune-mediated diseases. The company’s lead program, SP001, is a third-generation, Fc-silent anti-CD40L monoclonal antibody being advanced first in IgG4-related disease, with potential for development in additional immunological & inflammatory diseases. For more information, visit www.sperotx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, but are not limited to, statements relating to Spero’s plans to advance SP001 into a Phase 2 study in IgG4-related disease; Spero’s plans to explore the use of SP001, and the role of CD40L inhibition, in additional autoimmune and inflammatory diseases; the anticipated benefits of the non-dilutive royalty-backed transaction, including the anticipated use of proceeds; Spero’s expectation that Utebzi will be made available to U.S. patients by the end of 2026; anticipated cash runway, and future milestones. Forward-looking statements are based on Spero’s current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to the completion and integration of the Innovent transaction; Spero’s ability to successfully develop SP001; the timing and outcome of clinical trials and regulatory interactions; the ability to obtain and maintain regulatory approvals; potential safety, efficacy, manufacturing, supply, intellectual property, financing, competitive, and market risks; and other risks described in Spero’s filings with the Securities and Exchange Commission. Spero undertakes no obligation to update any forward-looking statements, except as required by law.
Investor Relations Contact:
Shai Biran, PhD
Spero Therapeutics
IR@Sperotherapeutics.com
Media Inquiries:
media@sperotherapeutics.com
| Spero Therapeutics, Inc. | ||||||
| Condensed Consolidated Balance Sheet Data | ||||||
| (in thousands) | ||||||
| (unaudited) | ||||||
| June 30, | December 31, | |||||
| 2026 | 2025 | |||||
| Cash and cash equivalents | $ | 50,774 | $ | 40,265 | ||
| Other assets | 1,992 | 28,654 | ||||
| Total assets | $ | 52,766 | $ | 68,919 | ||
| Total liabilities | 8,562 | 9,898 | ||||
| Total stockholder's equity | 44,204 | 59,021 | ||||
| Total liabilities and stockholders' equity | $ | 52,766 | $ | 68,919 | ||
| Spero Therapeutics, Inc. | ||||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant revenue | $ | — | 2,387 | $ | — | 3,150 | ||||||||||
| Collaboration revenue - related party | — | 11,802 | 258 | 16,901 | ||||||||||||
| Collaboration revenue | — | — | — | 12 | ||||||||||||
| Total revenues | — | 14,189 | 258 | 20,063 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,434 | 10,672 | 6,343 | 24,278 | ||||||||||||
| General and administrative | 6,492 | 5,878 | 11,379 | 12,702 | ||||||||||||
| Restructuring | — | 83 | — | 258 | ||||||||||||
| Total operating expenses | 9,926 | 16,633 | 17,722 | 37,238 | ||||||||||||
| Loss from operations | (9,926 | ) | (2,444 | ) | (17,464 | ) | (17,175 | ) | ||||||||
| Total other income, net | 374 | 744 | 709 | 1,609 | ||||||||||||
| Net loss | $ | (9,552 | ) | $ | (1,700 | ) | $ | (16,755 | ) | $ | (15,566 | ) | ||||
| Net loss per share attributable to common shareholders per share, basic and diluted | $ | (0.16 | ) | $ | (0.03 | ) | $ | (0.29 | ) | $ | (0.28 | ) | ||||
| Weighted average shares outstanding, basic and diluted: | 57,968,608 | 56,026,767 | 57,626,986 | 55,703,275 | ||||||||||||
