SION

Enrollment completed in the PreciSION CF Phase 2a proof-of-concept trial evaluating NBD1 stabilizer SION-719 as an add-on to standard of care in participants with cystic fibrosis; topline data on track for the summer of 2026 Ongoing Phase 1 trial evaluating NBD1 stabilizer SION-451 in proprietary dual combinations with SION-2222 and with SION-109 in healthy volunteers is also on track for topline data in the summer of 2026 Maintained strong cash position with approximately $289.9 million in cash and cash equivalents, expected to fund operations into 2028 WALTHAM, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- Sionna Therapeutics, Inc. (Nasdaq: SION), a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF) today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “We entered 2026 with strong execution across our programs, highlighted by the recent completion of enrollment in our proof-of-concept Phase 2a trial of SION-719, an important milestone for Sionna,” said Mike Cloonan, President and Chief Executive Officer of Sionna. “With both of our clinical stage NBD1 stabilizer programs on track for topline readouts this summer, we remain focused on advancing these first-in-class product candidates that could expand therapeutic options for people with CF.” Pipeline Updates NBD1 Stabilizers Enrollment Completed in PreciSION CF Phase 2a Proof-of-Concept Trial with SION-719; Topline Data On Track: In April 2026, Sionna announced it had completed enrollment in the PreciSION CF Phase 2a proof-of-concept (POC) trial (NCT07108153) evaluating SION-719 as an add-on to standard of care (SOC) in CF patients. The trial is evaluating the safety, tolerability, and pharmacokinetics (PK) of SION-719 when administered with SOC and assessing change in CFTR function as measured by sweat chloride levels. Topline data from this trial are anticipated in the summer of this year. Ongoing Phase 1 Dual Combination Trial with SION-451 and Complementary Modulators; Topline Data On Track: The Phase 1 trial (NCT07035990) is evaluating SION-451 in proprietary dual combinations with SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and with SION-109, an intracellular loop 4 (ICL4)-directed CFTR corrector, in healthy volunteers. Topline data from this...

Ongoing PreciSION CF Phase 2a proof-of-concept trial evaluating NBD1 stabilizer SION-719 as an add-on to standard of care in participants with cystic fibrosis is on track with topline data anticipated in mid-2026 Ongoing Phase 1 trial evaluating NBD1 stabilizer SION-451 in proprietary dual combinations with SION-2222 and with SION-109 in healthy volunteers is on track with topline data anticipated in mid-2026 Maintained strong cash position with approximately $310.3 million in cash and cash equivalents, expected to fund operations into 2028 WALTHAM, Mass., March 02, 2026 (GLOBE NEWSWIRE) -- Sionna Therapeutics, Inc. (Nasdaq: SION), a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF) by developing novel medicines that normalize the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “2025 was a remarkable and transformative year for Sionna. Propelled by the momentum of our upsized IPO in February, we have been steadily executing across our pipeline and strengthening the capabilities of our team. We delivered positive results from the two Phase 1 trials of our first-in-class NBD1 stabilizers SION-719 and SION-451 and expeditiously advanced these candidates into the next stages of development,” said Mike Cloonan, President and Chief Executive Officer of Sionna. “With topline readouts from both of our ongoing trials anticipated this year, along with the capital to support us into 2028, Sionna is making meaningful progress toward our goal to deliver additional options for those living with CF.” Pipeline Updates NBD1 Stabilizers Ongoing PreciSION CF Phase 2a Proof-of-Concept Trial with SION-719 On Track: In October 2025, Sionna announced the initiation of the PreciSION CF Phase 2a proof-of-concept (POC) trial (NCT07108153) evaluating SION-719 as an add-on to standard of care (SOC) in CF patients. The trial is evaluating the safety, tolerability, and pharmacokinetics (PK) of SION-719 when administered with SOC and assessing change in CFTR function as measured by sweat chloride levels. Topline data from this trial are anticipated in mid-2026. Ongoing Phase 1 Dual Combination Trial with SION-451 and Complementary Modulators On Track: I...

Initiated PreciSION CF Phase 2a proof-of-concept trial evaluating NBD1 stabilizer SION-719 as an add-on to standard of care in participants with cystic fibrosis Successfully completed drug-drug interaction study to support initiation of PreciSION CF Phase 2a Initiated Phase 1 trial evaluating NBD1 stabilizer SION-451 in proprietary dual combinations with SION-2222 and with SION-109 in healthy volunteers Topline data from both trials anticipated in mid-2026 Maintained strong cash position with approximately $325.0 million in cash and cash equivalents, expected to fund operations into 2028 WALTHAM, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Sionna Therapeutics, Inc. (Nasdaq: SION), a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF) by developing novel medicines that normalize the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, today reported financial results for the quarter ended September 30, 2025, and provided a business update. “We maintain our track record of strong execution, achieving substantial progress across our pipeline in the third quarter. Following the positive data from the two Phase 1 clinical trials evaluating our first-in-class NBD1 stabilizers SION-719 and SION-451, we have initiated both the PreciSION CF Phase 2a proof-of-concept trial of SION-719 as an add-on to standard of care and the Phase 1 trial of SION-451 in proprietary dual combinations. We are looking forward to sharing results from both trials in mid-2026,” said Mike Cloonan, President and Chief Executive Officer of Sionna. “Our recent engagement with the CF community at the North American Cystic Fibrosis Conference in October has reinforced the importance of our science and our mission to revolutionize the treatment paradigm for people living with CF.” Pipeline Updates NBD1 Stabilizers Initiated PreciSION CF Phase 2a Proof-of-Concept Trial with SION-719: In October 2025, Sionna announced initiation of the PreciSION CF Phase 2a proof-of-concept (POC) trial (NCT07108153) evaluating nucleotide binding domain 1 (NBD1) stabilizer SION-719 as an add-on to the current standard of care (SOC) in CF participants. The trial will evaluate the safety, tolerability, and pharmacokinetics (PK) of SION-719 when administered with SOC and assess change in CFTR function as measured by sw...

Announced positive Phase 1 data for SION-719 and SION-451 demonstrating both first-in-class NBD1 stabilizers were generally well tolerated and exceeded pharmacokinetic targets Initiation of Phase 2a proof-of-concept trial of SION-719 as an add-on to standard of care in cystic fibrosis patients is on track for the second half of 2025 with topline data expected in mid-2026 Advancement of Phase 1 healthy volunteer trial of SION-451 in two proprietary dual combinations is on track for the second half of 2025 with topline data expected in mid-2026 Maintained strong cash position with approximately $337.3 million in cash and cash equivalents, expected to fund operations into 2028 WALTHAM, Mass., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Sionna Therapeutics, Inc. (Nasdaq: SION), a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF) by developing novel medicines that normalize the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, today reported financial results for the quarter ended June 30, 2025, and provided a business update. “We are pleased with the progress we’ve made this past quarter, underscored by the encouraging tolerability and PK data from the Phase 1 trials of our first-in-class NBD1 stabilizers, SION-719 and SION-451,” said Mike Cloonan, President and Chief Executive Officer of Sionna. “These data reinforce our confidence in advancing both NBD1 stabilizers into the next stages of development. We are preparing to initiate the Phase 2a proof-of-concept trial of SION-719 as an add-on to standard of care and the Phase 1 trial of SION-451 in dual combinations this year and look forward to sharing topline results from both studies in mid-2026. Supported by a clear development plan and a strong financial position, we are excited to be advancing CF therapies that have the potential to make a meaningful difference for people affected by the disease.” Pipeline Updates NBD1 Stabilizers Positive Phase 1 Results for SION-719 and SION-451: In June 2025, Sionna announced positive Phase 1 data for its first-in-class nucleotide binding domain 1 (NBD1) stabilizers, SION-719 and SION-451. The randomized, double-blind, placebo-controlled trials enrolled over 200 healthy volunteers and evaluated each compound’s safety, tolerability, and pharmacokinetics (PK) across single...

Phase 1 dosing completed for NBD1 stabilizers SION-719 & SION-451; both compounds continue to be generally well tolerated Phase 1 topline data anticipated this quarter On track to initiate Phase 2a proof-of-concept trial and at least one dual combination MAD trial in the second half of 2025; topline data for both anticipated in mid-2026 Strong cash position following completed upsized IPO, with approximately $354.7 million in cash and cash equivalents, expected to fund operations into 2028 WALTHAM, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- Sionna Therapeutics, Inc. (Nasdaq: SION), a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF) by developing novel medicines that normalize the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, today reported financial results for the quarter ended March 31, 2025, and provided a business update. “Following our upsized IPO in February, we are in a strong financial position to advance our mission to transform the treatment paradigm for patients with CF,” said Mike Cloonan, President and Chief Executive Officer of Sionna. “We continue to execute across our pipeline and have completed dosing in our Phase 1 trials for both SION-719 and SION-451. We look forward to announcing topline data from these trials this quarter, and to initiating our Phase 2a POC trial and the combination MAD Phase 1 program later this year. With multiple meaningful milestones on the horizon, we are focused on execution and building on our strong momentum throughout 2025.” Pipeline Updates NBD1 Stabilizers Phase 1 Dosing Completed: Sionna has completed dosing in the single ascending dose (SAD), multiple ascending dose (MAD), and food effect and tablet bioequivalence parts of the Phase 1 healthy volunteer trials of SION-719 and SION-451. Both compounds continue to be generally well tolerated, and their safety profiles remain consistent with prior disclosures. Full topline data are on schedule to be reported the second quarter of 2025. As previously reported in interim data, target exposures were achieved that have the potential, based on Sionna’s preclinical cystic fibrosis human bronchial epithelial (CFHBE) model, to provide clinically meaningful benefit to patients if SION-719 or SION-451 were administered as part of a dual combination with one of...

Phase 1 MAD dosing completed for SION-451 and final MAD cohort of SION-719 planned; Interim data in healthy volunteers show potential to provide clinically meaningful benefit to CF patients. Topline data anticipated in first half of 2025 On track to initiate NBD1 Phase 2a proof-of-concept trial in combination with SOC in CF patients and combination MAD trials of an NBD1 stabilizer with a complementary modulator in healthy volunteers in the second half of 2025, with topline data for both anticipated in mid-2026 Completed upsized IPO with gross proceeds of approximately $219 million, extending runway into 2028 WALTHAM, Mass., March 20, 2025 (GLOBE NEWSWIRE) -- Sionna Therapeutics, Inc. (Nasdaq: SION), a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF) by developing novel medicines that normalize the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. “2024 was an excellent year for Sionna including strong clinical execution across multiple programs. Encouraging interim Phase 1 data for SION-719 and SION-451, our highly potent nucleotide-binding domain 1 (NBD1) stabilizers, showed that both candidates were generally well tolerated and achieved target exposures—reinforcing their potential to deliver meaningful clinical benefits for people with CF,” said Mike Cloonan, President and Chief Executive Officer of Sionna. “Building on this momentum, we successfully completed an upsized IPO, a significant milestone that extends our cash runway into 2028 and provides financial and strategic flexibility. 2025 is off to a strong start with the consummation of the IPO and the progression of the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trials for SION-719 and SION-451. We look forward to announcing topline data in the first half of this year and initiating our Phase 2a proof-of-concept (POC) trial and the combination MAD Phase 1 program later this year.” Pipeline Updates NBD1 Stabilizers Phase 1 MAD advancement: Sionna has completed dosing in the MAD part of the Phase 1 healthy volunteer trial of SION-451 and the final MAD cohort of SION-719 is planned. The additional completed cohorts since Sionna reported interi...