Sionna Therapeutics Inc(US:SION)2025-05-12 11:31Part I - Financial Information Financial Statements (Unaudited) The company significantly strengthened its balance sheet post-IPO, though operating losses continued to grow due to increased R&D and G&A expenses - In February 2025, the company completed its IPO, raising net proceeds of approximately $199.6 million and converting all outstanding redeemable convertible preferred stock to common stock40 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $82,695 | $37,788 | | Marketable securities (current & noncurrent) | $271,993 | $130,255 | | Total Assets | $369,674 | $185,752 | | Total liabilities | $17,905 | $19,097 | | Total convertible preferred stock | $0 | $330,368 | | Total stockholders' equity (deficit) | $351,769 | ($163,713) | Condensed Consolidated Statements of Operations (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $13,668 | $10,220 | | General and administrative | $5,991 | $2,927 | | Loss from operations | ($19,659) | ($13,147) | | Interest income | $3,000 | $1,132 | | Net loss | ($16,482) | ($11,847) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($16,288) | ($13,175) | | Net cash used in investing activities | ($141,194) | ($123,927) | | Net cash provided by financing activities | $202,389 | $181,333 | Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A) The company's net loss grew to $16.5 million in Q1 2025, but its post-IPO cash position of $354.7 million is expected to fund operations into 2028 - The company's mission is to revolutionize CF treatment by developing medicines that normalize CFTR protein function, focusing on stabilizing the NBD1 domain69 - Topline data from Phase 1 trials of NBD1 stabilizers SION-719 and SION-451 are expected in Q2 2025, with a proof-of-concept trial planned for H2 20257172 - As of March 31, 2025, the company had $354.7 million in cash, cash equivalents, and marketable securities, sufficient to support operations into 202884113 - The $3.4 million increase in R&D expenses was primarily due to a $1.9 million increase in direct costs for clinical programs and a $1.2 million increase in personnel-related expenses101 - The $3.1 million increase in G&A expenses was driven by a $2.0 million increase in personnel-related costs and a $1.0 million increase in professional services fees102108 Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $13,668 | $10,220 | $3,448 | | General and administrative | $5,991 | $2,927 | $3,064 | | Total operating expenses | $19,659 | $13,147 | $6,512 | Quantitative and Qualitative Disclosures About Market Risk The company is exempt from providing market risk disclosures as it qualifies as a smaller reporting company under SEC regulations - As a "smaller reporting company," Sionna Therapeutics is exempt from providing the disclosures required by Item 305 of Regulation S-K124 Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls during the quarter - Management's evaluation concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of the end of the period covered by the report125 - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls126 Part II - Other Information Legal Proceedings The company is not currently involved in any material legal proceedings, nor is management aware of any pending or threatened material legal matters - The company's management is currently not aware of any legal matters that could have a material effect on its financial position, results of operations, or cash flows128 Risk Factors The company faces significant financial, developmental, competitive, and third-party dependency risks, including a history of losses and reliance on novel drug candidates - The company is a clinical-stage biopharmaceutical company with significant operating losses ($16.5 million for Q1 2025) and an accumulated deficit of $197.6 million as of March 31, 2025130131 - The business is substantially dependent on the success of its NBD1 stabilizer product candidates (e.g., SION-719, SION-451), which target a novel protein domain, making development inherently risky145180 - The company faces substantial competition from established players, with its main competitor, Vertex, holding a significant market share and possessing greater resources314315 - Sionna is dependent on intellectual property licensed from third parties like Sanofi and AbbVie and relies on CROs and CDMOs for clinical trials and manufacturing214215219223 - Lock-up agreements covering approximately 35.3 million shares of common stock from the IPO will expire in August 2025, potentially leading to significant sales and stock price volatility357 Unregistered Sales of Equity Securities and Use of Proceeds The company's IPO in February 2025 generated net proceeds of $199.6 million, with no material change in the planned use of these funds - The company's IPO registration statement (File No. 333-284352) became effective on February 6, 2025411 - There has been no material change in the planned use of the net proceeds from the IPO as described in the final prospectus412 Initial Public Offering (IPO) Details | Metric | Value | | :--- | :--- | | Shares Sold (incl. underwriter option) | 12,176,467 | | Price per Share | $18.00 | | Aggregate Net Proceeds | ~$199.6 million | Defaults Upon Senior Securities The company reports no defaults upon senior securities - None415 Mine Safety Disclosures This item is not applicable to the company - Not applicable416 Other Information No directors or executive officers of the company adopted, modified, or terminated a Rule 10b5-1 trading plan during the first quarter of 2025 - During the quarter ended March 31, 2025, none of the company's directors or executive officers adopted, modified, or terminated any trading plan intended to satisfy the conditions of Rule 10b5-1(c)417 Exhibits This section lists exhibits filed with the report, including corporate governance documents, stock plans, and required officer certifications - The report includes key corporate governance documents, such as the Fifth Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws420 - Compensatory plans filed as exhibits include the 2025 Stock Option and Incentive Plan, the 2025 Employee Stock Purchase Plan, and the Senior Executive Cash Incentive Bonus Plan420 - Certifications by the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are included as exhibits420