SPRO — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-12

• We are a clinical-stage biopharmaceutical company advancing next generation medicines for patients with immune-mediated diseases.

• Our lead program, SP001, is a third-generation, fully humanized, Fc-silent IgG1 monoclonal antibody targeting CD40L. On July 8, 2026, we entered into the Innovent Agreement with Innovent, pursuant to which Innovent granted the Company an exclusive (even as to Innovent and its affiliates, subject to …

• SP001 targets CD40L, an immune signal protein that sits upstream of multiple immune pathways and has the potential to be developed across a range of immune-mediated diseases. We are developingSP001 for the treatment of patients with Immunoglobulin G4 related disease, or IgG4-RD. IgG4-RD is a rare di…

• In September 2022, we entered into an exclusive licensing agreement with GSK for Utebzi (tebipenem pivoxil), which included transfer of the IND application and NDA ownership to GSK. We initially developed Utebzi as tebipenem HBr. In May 2025, we and GSK announced that the pivotal Phase 3 PIVOT-PO tr…

• We have experienced mostly net losses and significant cash outflows from cash used in operating activities since our inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development of SP001 and any other product candidate we ma…

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• We are a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need.

• Our clinical-stage product candidate, tebipenem HBr, has completed a second Phase 3 trial, and we believe has the potential to be the first oral carbapenem to treat adult patients with complicated urinary tract infections (“cUTIs”), including pyelonephritis, caused by certain microorganisms. In Sept…

• Following the termination of our earlier stage programs (SPR206 and SPR720), we remain focused on supporting GSK in the FDA approval process pursuant to our obligations under the GSK License Agreement and advancing other corporate activities, including exploring opportunities to grow our portfolio o…

• We have experienced mostly net losses and significant cash outflows from cash used in operating activities since our inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and commercialization of tebipenem HBr, or any…

• We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for any of our product candidates. If we obtain regulatory approval for any of our future product candidates and do not enter into a commercialization partner…

Text added vs the prior filing · source: 10-Q · 2026-08-12

• We are substantially dependent on the success of our new product candidate, SP001, and focus on SP001 may not be successful.

• On June 17, 2026, we and GSK announced that the FDA approved Utebzi (tebipenem pivoxil). We are party to an exclusive license agreement with GSK for the development, manufacture and commercialization of Utebzi, which includes the transfer of the

• IND and the NDA ownership to GSK, and pursuant to which GSK is obligated to make milestone payments if certain milestones are achieved and to pay royalties based on commercial launch and achievement of pre-specified sales thresholds. On July 8, 2026, we and our affiliates entered into a non-recourse…

• Following the FDA approval of Utebzi, and the termination of our earlier stage programs (SPR206 and SPR720), we remain focused on advancing other corporate activities, including growing our portfolio of clinical-stage product candidates. On July 8, 2026, we entered into a license agreement with Inno…

• Our business and future success depends on our ability to successfully develop, obtain regulatory approval for and successfully commercialize our new lead product candidate, SP001. SP001 is our only product candidate currently in clinical development, and our business depends on its successful devel…

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• As of March 2025, we have ceased development of our SPR206 program, and as of November 2025, we have ceased development of our SPR720 oral program, and have shifted our focus and resources to advancing the development of the tebipenem HBr program, as well as other corporate activities. Consequently,…

• As of March 2025, we have ceased development of SPR206. Additionally, as of November 2025, we have ceased development of our SPR720 oral program and have shifted our focus and resources to advancing the clinical development of our tebipenem HBr program, as well as other corporate activities. We beli…

• As a result, we are currently substantially dependent on our tebipenem program and our collaboration with GSK. As described under Note 9 to our condensed consolidated financial statements, GSK has the right to terminate the GSK License Agreement (1) at any time upon a specified number of days’ notic…

• 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.

• We currently have no products approved for sale and have invested a significant portion of our efforts and financial resources in the development of tebipenem HBr as a product candidate for the treatment of bacterial infections causing cUTI. Our ability to realize the value of tebipenem HBr, current…