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Spero Therapeutics (SPRO) widens Q2 loss but lands $105M non-dilutive financing

(High)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Spero Therapeutics reported second quarter 2026 results and provided a business update. The company highlighted three key milestones: U.S. FDA approval of Utebzi (tebipenem pivoxil), advancement of its new immunology program SP001 toward Phase 2, and a $105 million non-recourse, non-dilutive royalty financing.

For the quarter ended June 30, 2026, Spero reported no revenues, compared with $14.2 million in total revenues in the same quarter of 2025, reflecting the absence of prior grant and related-party collaboration revenue. Operating expenses were $9.9 million, versus $16.6 million a year earlier, driven by lower research and development spending.

Net loss for the quarter was $9.6 million (basic and diluted net loss per share of $0.16), compared with a net loss of $1.7 million (per share $0.03) in the prior-year quarter. As of June 30, 2026, cash and cash equivalents totaled $50.8 million, up from $40.3 million at December 31, 2025. Total assets were $52.8 million and stockholders’ equity was $44.2 million. The company continues to position SP001, a third-generation Fc-silent anti-CD40L monoclonal antibody, for development in IgG4-related and other immune-mediated diseases.

Positive

  • U.S. FDA approval of Utebzi (tebipenem pivoxil) provides Spero with an approved product, a major milestone that can support its strategic and financial position.
  • The company entered into a $105 million non-recourse, non-dilutive royalty financing, which provides significant capital without issuing equity, limiting shareholder dilution.
  • Cash and cash equivalents increased to $50.8 million as of June 30, 2026, from $40.3 million at December 31, 2025, strengthening the near-term liquidity profile.

Negative

  • Total revenues for the quarter were $0, compared with $14.2 million in the prior-year quarter, reflecting a sharp decline in grant and collaboration income.
  • Quarterly net loss widened to $9.6 million from $1.7 million a year earlier, and net loss per share increased from $0.03 to $0.16.
  • Total assets declined to $52.8 million at June 30, 2026, from $68.9 million at December 31, 2025, and stockholders’ equity fell from $59.0 million to $44.2 million.

Filing Explained

Cash of 50,774,000 dollars equaled 853.3 days of latest-quarter operating cash use; Utebzi patient availability remained a year-end expectation.

The August 12 Form 8-K furnishes Spero’s second-quarter release, a filing type used to report specified material events within four business days.

At June 30, 2026, cash and equivalents were $50,774,000; that balance equals 853.3 days of the latest quarter’s operating cash use, a backward-looking liquidity comparison rather than a forecast.

The release describes Utebzi as FDA-approved, but says making it available to U.S. patients by the end of 2026 remains an expectation, so patient availability is a future milestone rather than a completed one.

Sources and calculations
  • Cash and equivalents vs quarterly operating cash outflow, in days of cash use $50,774,000 / ($5,355,000 / 90) = [object Object]
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash and cash equivalents $50,774 As of June 30, 2026
Total revenues Q2 2026 $0 Three months ended June 30, 2026
Total revenues Q2 2025 $14,189 Three months ended June 30, 2025
Net loss Q2 2026 $9,552 Three months ended June 30, 2026
Net loss Q2 2025 $1,700 Three months ended June 30, 2025
Non-recourse royalty financing $105,000 Non-recourse, non-dilutive royalty financing amount
Total assets $52,766 As of June 30, 2026
Weighted average shares Q2 2026 57,968,608 Weighted average shares outstanding, basic and diluted, quarter ended June 30, 2026
non-recourse, non-dilutive royalty financing financial
"A $105 Million Non-Recourse, Non-Dilutive Royalty Financing"
Fc-silent IgG1 monoclonal antibody medical
"SP001 is a third-generation, potential best-in-class, fully humanized, Fc-silent IgG1 monoclonal antibody"
CD40L medical
"monoclonal antibody targeting CD40L, an upstream immune activation signal"
CD40L (CD40 ligand) is a protein found on the surface of certain immune cells that acts like a molecular switch, helping immune cells talk to one another and coordinate responses. Investors should care because drugs that block or mimic this switch are common targets in biotech — they can treat autoimmune diseases, prevent transplant rejection, or boost vaccines — and clinical trial results or safety issues around CD40L-targeting therapies can strongly affect a company’s value.
immune-mediated diseases medical
"development opportunities in immune-mediated diseases to expand the SP001 value proposition"
Total revenues $0
Net loss $9,552
Net loss per share, basic and diluted $0.16
Total operating expenses $9,926

FAQ

What were Spero Therapeutics (SPRO) revenues in the second quarter of 2026?

Spero Therapeutics reported no revenues in the second quarter of 2026, compared with $14.2 million in total revenues in the same period of 2025, reflecting the lack of prior grant and related-party collaboration revenue streams.

What net loss did Spero Therapeutics (SPRO) report for Q2 2026?

Spero reported a net loss of $9.6 million for the quarter ended June 30, 2026, versus $1.7 million a year earlier. Basic and diluted net loss per share was $0.16, compared with $0.03 in the prior-year quarter.

How much cash did Spero Therapeutics (SPRO) have as of June 30, 2026?

As of June 30, 2026, Spero Therapeutics had $50.8 million in cash and cash equivalents, up from $40.3 million at December 31, 2025, supporting its clinical and corporate development plans.

What major strategic milestones did Spero Therapeutics (SPRO) highlight in this update?

Spero highlighted FDA approval of Utebzi, progress of SP001 as a Phase 2-ready immunology program, and a $105 million non-recourse, non-dilutive royalty financing, all described as key milestones strengthening its business.

What is SP001 in Spero Therapeutics’ (SPRO) pipeline?

SP001 is a third-generation, fully humanized, Fc-silent IgG1 monoclonal antibody targeting CD40L. Spero plans to advance SP001 into a Phase 2 study in IgG4-related disease and evaluate additional immune-mediated disease indications.

How did Spero Therapeutics’ (SPRO) operating expenses change year over year in Q2 2026?

Total operating expenses were $9.9 million in Q2 2026, compared with $16.6 million in Q2 2025. Research and development expenses decreased from $10.7 million to $3.4 million, while general and administrative expenses rose from $5.9 million to $6.5 million.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001701108 0001701108 2026-08-12 2026-08-12
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 12, 2026

 

 

SPERO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38266   46-4590683
(State or other jurisdiction
of incorporation)
 

(Commission

File Number)

  (I.R.S. Employer
Identification No.)

 

675 Massachusetts Avenue, 14th Floor  
Cambridge, Massachusetts   02139
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code (857) 242-1600

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange
on which registered

Common Stock, $0.001 par value   SPRO   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 


Item 2.02

Results of Operations and Financial Condition.

On August 12, 2026, Spero Therapeutics, Inc. (the “Company”) issued a press release announcing its results for the second quarter ended June 30, 2026. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in this Item 2.02 and in the press release furnished as Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, or incorporated by reference in any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.


Item 9.01

Financial Statements and Exhibits

(d) Exhibits

 

Exhibit
No.

  

Description

99.1    Press release issued by Spero Therapeutics, Inc. on August 12, 2026
104    Cover Page Interactive Data File (embedded within the Inline XBRL document and incorporated as Exhibit 101)


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: August 12, 2026   SPERO THERAPEUTICS, INC.
    By:  

/s/ Esther Rajavelu

      Esther Rajavelu
      Chief Executive Officer and Chief Financial Officer

Exhibit 99.1

 

LOGO

Spero Therapeutics Announces Second Quarter 2026 Operating Results and Provides Business Update

 

   

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, 2026Spero 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.


LOGO

 

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.

$105 Million Non-Recourse, Non-Dilutive Royalty Financing

 

   

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.


LOGO

 

   

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.


LOGO

 

Investor Relations Contact:

Shai Biran, PhD

Spero Therapeutics

IR@Sperotherapeutics.com

Media Inquiries:

media@sperotherapeutics.com


LOGO

 

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  

Filing Exhibits & Attachments

4 documents