Sionna Therapeutics Inc(SION) - 2025 Q2 - Quarterly Results

Executive Summary Key Highlights Sionna Therapeutics reported positive Phase 1 data for NBD1 stabilizers, is advancing to Phase 2a and dual combination trials in H2 2025, and holds $337.3 million in cash to fund operations into 2028 - Positive Phase 1 data for SION-719 and SION-451 demonstrated both NBD1 stabilizers were generally well tolerated and exceeded pharmacokinetic targets[1] - Initiation of Phase 2a proof-of-concept trial of SION-719 and advancement of Phase 1 healthy volunteer trial of SION-451 in two proprietary dual combinations are on track for the second half of 2025, with topline data expected in mid-2026[1] Cash Position and Funding Outlook | Metric | Amount (Millions) | | :----- | :---------------- | | Cash, cash equivalents, and marketable securities (as of June 30, 2025) | $337.3 | | Expected to fund operations | Into 2028 | Business Update CEO Commentary CEO Mike Cloonan expressed satisfaction with positive Phase 1 data for SION-719 and SION-451, reinforcing confidence in advancing NBD1 stabilizers to Phase 2a and dual combination trials this year with mid-2026 topline results - CEO Mike Cloonan expressed pleasure with progress, citing encouraging tolerability and PK data from Phase 1 trials of SION-719 and SION-451[2] - Confidence in advancing both NBD1 stabilizers into next development stages, with Phase 2a SION-719 and Phase 1 SION-451 dual combination trials planned for initiation this year and topline results in mid-2026[2] Pipeline Updates Sionna provided updates on NBD1 stabilizers SION-719 and SION-451, including positive Phase 1 results, plans for Phase 2a and Phase 1 dual combination trials, and preclinical data showing full F508del-CFTR correction with dual combinations NBD1 Stabilizers (SION-719 & SION-451) Positive Phase 1 results for SION-719 and SION-451, announced in June 2025, demonstrated general tolerability and exceeded target exposure levels in healthy volunteers, suggesting potential for clinically meaningful benefit as add-on or dual combination therapies - Positive Phase 1 data for SION-719 and SION-451 announced in June 2025, demonstrating general tolerability and exceeding target exposure levels in over 200 healthy volunteers[3] - Data reinforces Sionna's decision to progress SION-719 and SION-451, believing they have the potential for clinically meaningful benefit as add-on therapies or in proprietary dual combinations[3] Phase 2a Proof-of-Concept Trial with SION-719 Sionna is on track to initiate a Phase 2a proof-of-concept trial for SION-719 in H2 2025, with topline data anticipated in mid-2026, following completion of a midazolam drug-drug interaction study - Phase 2a proof-of-concept trial for SION-719 as an add-on to standard of care in CF patients is on track for H2 2025, with topline data expected in mid-2026[3] - The trial aims to demonstrate the unique mechanism of NBD1 stabilization and potential to improve CFTR function beyond current SOC, as defined by sweat chloride[3] - Midazolam drug-drug interaction study for SION-719 initiated and on track for completion prior to Phase 2a trial[4] Phase 1 Dual Combination Trial with SION-451 and Complementary Modulators Sionna plans to advance a Phase 1 healthy volunteer trial for SION-451 in dual combination with SION-2222 and SION-109 in H2 2025, with topline data expected in mid-2026 - Phase 1 healthy volunteer trial evaluating SION-451 in combination with SION-2222 (TMD1-directed CFTR corrector) and SION-109 (ICL4-directed CFTR corrector) is on track for H2 2025[9] - Topline data from the SION-451 dual combination trial is anticipated in mid-2026[9] Preclinical Data Presented at 48th European Cystic Fibrosis Conference Sionna presented preclinical data at the 48th ECFS Annual Conference in June 2025, demonstrating full correction of F508del-CFTR in CF models using NBD1 stabilizers in dual combinations with complementary modulators - Preclinical data presented at 48th ECFS Annual Conference in June 2025 demonstrated full correction of F508del-CFTR in CF models using Sionna's NBD1 stabilizers in dual combinations with proprietary complementary modulators[9] - These findings highlight the strong mechanistic rationale and synergy of Sionna's dual combination approach to restoring CFTR function[9] Financial Results Second Quarter 2025 Financial Performance Sionna Therapeutics reported increased Q2 2025 operating expenses, driven by higher R&D and G&A costs, resulting in a widened net loss of $18.1 million compared to $8.6 million in Q2 2024 Research and Development Expenses Research and development expenses significantly increased to $15.4 million in Q2 2025 from $8.2 million in Q2 2024, primarily due to direct program spend supporting Sionna's clinical pipeline Research and Development Expenses (QoQ) | Period | 2025 Q2 (in thousands) | 2024 Q2 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | R&D Expenses | $15,383 | $8,233 | +86.8% | - Increase mainly driven by direct program spend to support Sionna's clinical pipeline[5] General and Administrative Expenses General and administrative expenses rose to $6.5 million in Q2 2025 from $3.1 million in Q2 2024, primarily due to personnel-related costs and professional fees General and Administrative Expenses (QoQ) | Period | 2025 Q2 (in thousands) | 2024 Q2 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | G&A Expenses | $6,523 | $3,059 | +113.2% | - Increase primarily due to personnel-related costs, including stock-based compensation, and professional fees[6] Net Loss The net loss for Q2 2025 was $18.1 million, significantly higher than the $8.6 million net loss in Q2 2024, reflecting increased operating expenses Net Loss (QoQ) | Period | 2025 Q2 (in thousands) | 2024 Q2 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | Net Loss | $(18,068) | $(8,552) | +111.3% | Cash Position and Outlook As of June 30, 2025, Sionna held $337.3 million in cash, cash equivalents, and marketable securities, anticipated to fund operations into 2028 Cash Position and Funding Outlook | Metric | Amount (Millions) | Funding Outlook | | :----- | :---------------- | :-------------- | | Cash, cash equivalents, and marketable securities (as of June 30, 2025) | $337.3 | Into 2028 | Company Overview About Sionna Therapeutics Sionna Therapeutics is a clinical-stage biopharmaceutical company focused on revolutionizing cystic fibrosis treatment by developing novel medicines that normalize CFTR protein function through NBD1 stabilization and complementary modulators - Sionna Therapeutics is a clinical-stage biopharmaceutical company focused on normalizing CFTR protein function to revolutionize cystic fibrosis treatment[8] - The company's goal is to restore CFTR function by directly stabilizing its NBD1 domain and developing complementary CFTR modulators to work synergistically[8] - Leveraging over a decade of NBD1 research, Sionna is advancing small molecules engineered to correct defects caused by the F508del genetic mutation[8] Additional Information Investor Relations and Disclosure Sionna intends to use its Investor Relations website for disclosing material nonpublic information and fulfilling Regulation FD obligations, advising investors to monitor it alongside other public communications - Sionna intends to use its Investor Relations website for disclosing material nonpublic information and complying with Regulation FD[9][10] - Investors should monitor the Investor Relations website in addition to press releases, SEC filings, public conference calls, presentations, and webcasts[10] Cautionary Note Regarding Forward-Looking Statements This section highlights forward-looking statements subject to risks and uncertainties regarding clinical trial timing, results, safety, efficacy, and financial projections, advising that actual results may differ materially and disclaiming any obligation to update these statements except as required by law - The press release contains forward-looking statements regarding Sionna's goals, R&D programs, clinical trials (initiation, timing, results), product candidate safety/efficacy, preclinical study predictability, and financial projections[11] - These statements are subject to risks and uncertainties inherent in product development, regulatory developments, and economic conditions, which may cause actual results to differ materially[11] - Sionna explicitly disclaims any obligation to update forward-looking statements except as required by law[11] Media and Investor Contacts Contact information for media inquiries (Adam Daley, CG Life) and investor relations (Juliet Labadorf) is provided - Media contact: Adam Daley, CG Life (adaley@cglife.com, 212.253.8881)[12] - Investor contact: Juliet Labadorf (ir@sionnatx.com)[12] Consolidated Financial Statements Consolidated Statements of Operations The Consolidated Statements of Operations show a significant increase in operating expenses and net loss for both the three and six months ended June 30, 2025, compared to 2024, primarily driven by research and development and general and administrative expenses Consolidated Statements of Operations (Selected Data, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $15,383 | $8,233 | $29,051 | $18,453 | | General and administrative | $6,523 | $3,059 | $12,514 | $5,986 | | Total operating expenses | $21,906 | $11,292 | $41,565 | $24,439 | | Loss from operations | $(21,906) | $(11,292) | $(41,565) | $(24,439) | | Interest income | $3,667 | $2,566 | $6,667 | $3,698 | | Net loss | $(18,068) | $(8,552) | $(34,550) | $(20,399) | | Net loss per share, basic and diluted | $(0.41) | $(2.71) | $(0.98) | $(6.54) | | Weighted-average common shares outstanding | 44,116,997 | 3,159,815 | 35,404,928 | 3,121,225 | Selected Consolidated Balance Sheet Data Sionna's balance sheet data as of June 30, 2025, shows a significant increase in cash, cash equivalents, and marketable securities to $337.3 million from $168.0 million, with total assets and stockholders' equity also increasing substantially Selected Consolidated Balance Sheet Data (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :---------------------------------- | :-------------- | :---------------- | :----- | | Cash, cash equivalents, and marketable securities | $337,270 | $168,043 | +$169,227 | | Working capital | $259,196 | $140,573 | +$118,623 | | Total assets | $352,048 | $185,752 | +$166,296 | | Total stockholders' equity (deficit) | $336,429 | $(163,713) | +$500,142 | - Working capital is defined as current assets minus current liabilities[16]