Sionna Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results
Sionna Therapeutics (SION) has reported its Q4 and full year 2024 financial results, highlighting significant progress in its cystic fibrosis (CF) treatment programs. The company completed Phase 1 MAD dosing for SION-451 and plans the final MAD cohort for SION-719, with both compounds showing encouraging tolerability profiles. Interim data indicates potential clinical benefits for CF patients, with topline data expected in H1 2025.
The company successfully completed an upsized IPO raising $219 million in gross proceeds, extending their cash runway into 2028. Financial results show R&D expenses of $57.3 million and G&A expenses of $13.3 million for 2024, with a net loss of $61.7 million. The company plans to initiate NBD1 Phase 2a proof-of-concept trials and combination MAD trials in H2 2025, with topline data anticipated in mid-2026.
Sionna Therapeutics (SION) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando progressi significativi nei suoi programmi di trattamento per la fibrosi cistica (CF). L'azienda ha completato la somministrazione della dose MAD di Fase 1 per SION-451 e prevede il gruppo finale di MAD per SION-719, con entrambi i composti che mostrano profili di tollerabilità incoraggianti. I dati preliminari indicano potenziali benefici clinici per i pazienti affetti da CF, con i dati principali attesi nel primo semestre del 2025.
L'azienda ha completato con successo un'IPO ampliata, raccogliendo 219 milioni di dollari in proventi lordi, estendendo la loro liquidità fino al 2028. I risultati finanziari mostrano spese per R&S di 57,3 milioni di dollari e spese generali e amministrative di 13,3 milioni di dollari per il 2024, con una perdita netta di 61,7 milioni di dollari. L'azienda prevede di avviare studi clinici di Fase 2a per NBD1 e studi combinati MAD nel secondo semestre del 2025, con dati principali attesi a metà 2026.
Sionna Therapeutics (SION) ha reportado sus resultados financieros del cuarto trimestre y del año completo 2024, destacando avances significativos en sus programas de tratamiento para la fibrosis quística (CF). La compañía completó la dosificación MAD de Fase 1 para SION-451 y planea el grupo final de MAD para SION-719, con ambos compuestos mostrando perfiles de tolerabilidad alentadores. Los datos interinos indican beneficios clínicos potenciales para los pacientes con CF, con datos principales esperados en el primer semestre de 2025.
La compañía completó con éxito una IPO ampliada, recaudando 219 millones de dólares en ingresos brutos, extendiendo su liquidez hasta 2028. Los resultados financieros muestran gastos de I+D de 57,3 millones de dólares y gastos generales y administrativos de 13,3 millones de dólares para 2024, con una pérdida neta de 61,7 millones de dólares. La compañía planea iniciar ensayos de prueba de concepto de Fase 2a para NBD1 y ensayos combinados MAD en el segundo semestre de 2025, con datos principales anticipados para mediados de 2026.
시온나 테라퓨틱스 (SION)는 2024년 4분기 및 연간 재무 결과를 보고하며, 낭포성 섬유증 (CF) 치료 프로그램에서의 상당한 진전을 강조했습니다. 회사는 SION-451의 1상 MAD 용량을 완료했으며 SION-719의 최종 MAD 집단을 계획하고 있으며, 두 화합물 모두 고무적인 내약성 프로필을 보여주고 있습니다. 중간 데이터는 CF 환자에게 잠재적인 임상적 이점을 나타내며, 주요 데이터는 2025년 상반기에 예상됩니다.
회사는 2억 1천 9백만 달러의 총 수익을 올리며 확대된 IPO를 성공적으로 완료하여 2028년까지 자금 조달을 연장했습니다. 재무 결과는 2024년 R&D 비용이 5천 7백 30만 달러, 일반 관리 비용이 1천 3백 30만 달러이며, 순손실은 6천 1백 70만 달러로 나타났습니다. 회사는 2025년 하반기에 NBD1 2a 단계 개념 증명 시험과 조합 MAD 시험을 시작할 계획이며, 주요 데이터는 2026년 중반에 예상됩니다.
Sionna Therapeutics (SION) a publié ses résultats financiers pour le quatrième trimestre et l'année complète 2024, mettant en évidence des progrès significatifs dans ses programmes de traitement de la fibrose kystique (CF). La société a terminé l'administration de la dose MAD de Phase 1 pour SION-451 et prévoit le dernier groupe MAD pour SION-719, les deux composés montrant des profils de tolérance encourageants. Les données préliminaires indiquent des avantages cliniques potentiels pour les patients atteints de CF, avec des données principales attendues au premier semestre 2025.
La société a réussi à réaliser une IPO élargie, levant 219 millions de dollars de produits bruts, prolongeant ainsi sa trésorerie jusqu'en 2028. Les résultats financiers montrent des dépenses de R&D de 57,3 millions de dollars et des dépenses générales et administratives de 13,3 millions de dollars pour 2024, avec une perte nette de 61,7 millions de dollars. La société prévoit de lancer des essais de preuve de concept de Phase 2a pour NBD1 et des essais combinés MAD au second semestre 2025, avec des données principales anticipées pour mi-2026.
Sionna Therapeutics (SION) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und erhebliche Fortschritte in seinen Programmen zur Behandlung von Mukoviszidose (CF) hervorgehoben. Das Unternehmen hat die MAD-Dosierung der Phase 1 für SION-451 abgeschlossen und plant die letzte MAD-Kohorte für SION-719, wobei beide Verbindungen ermutigende Verträglichkeitsprofile zeigen. Vorläufige Daten deuten auf potenzielle klinische Vorteile für CF-Patienten hin, wobei die Hauptdaten im ersten Halbjahr 2025 erwartet werden.
Das Unternehmen hat erfolgreich ein erweitertes IPO abgeschlossen und 219 Millionen Dollar an Bruttoeinnahmen gesammelt, wodurch die finanzielle Laufzeit bis 2028 verlängert wird. Die finanziellen Ergebnisse zeigen F&E-Ausgaben von 57,3 Millionen Dollar und allgemeine Verwaltungskosten von 13,3 Millionen Dollar für 2024, mit einem Nettoverlust von 61,7 Millionen Dollar. Das Unternehmen plant, in der zweiten Hälfte von 2025 Phase-2a-Studien für NBD1 und kombinierte MAD-Studien zu starten, wobei die Hauptdaten Mitte 2026 erwartet werden.
- Successful upsized IPO raising $219M gross proceeds
- Extended cash runway into 2028
- Positive interim Phase 1 data showing good tolerability for both SION-451 and SION-719
- Completed Phase 1 MAD dosing for SION-451
- Successfully achieved target drug exposures in clinical trials
- Increased net loss to $61.7M in 2024 from $47.3M in 2023
- R&D expenses increased 41% to $57.3M
- G&A expenses rose 37% to $13.3M
Insights
Sionna Therapeutics' Q4 and full-year 2024 results demonstrate strong financial positioning following their upsized IPO that raised
The company reported a net loss of
R&D expenses increased to
With
Sionna's clinical progress with their NBD1 stabilizers represents a scientifically significant approach to treating cystic fibrosis. Both SION-451 and SION-719 have completed or nearly completed multiple ascending dose (MAD) studies with encouraging preliminary safety profiles—no serious adverse events, primarily mild-to-moderate treatment-emergent adverse events, and importantly, no liver function abnormalities that have historically complicated CF drug development.
The company's scientific strategy targets the nucleotide-binding domain 1 (NBD1) of the CFTR protein, which represents a mechanistically distinct approach from current standard-of-care therapies. Their preclinical CFHBE (cystic fibrosis human bronchial epithelial) models suggest their compounds achieve exposures that could provide clinically meaningful benefit either in combination with complementary modulators or as add-ons to existing therapies.
Their clinical development strategy is methodically structured with logical progression: Phase 1 healthy volunteer studies to establish safety and target exposure, drug-drug interaction studies to evaluate compatibility with existing therapies, followed by Phase 2a proof-of-concept trials in CF patients. The planned initiation of combination studies with their complementary modulators (galifactor/SION-2222 and SION-109) in H2 2025 represents a critical step toward their ultimate goal of developing potentially more effective combination therapies.
The successful completion of SION-109's Phase 1 trial, showing it achieved target exposure when combined with their NBD1 stabilizers, validates their platform approach. This systematic development of complementary modulators that work through different mechanisms provides multiple potential paths to clinical success, mitigating the risk inherent in single-asset development strategies typical in biotech.
Sionna Therapeutics' Q4 and full-year 2024 results showcase a company with exceptional financial strength following their substantially upsized IPO that raised
The company's CF therapeutic approach targeting NBD1 stabilization addresses a fundamental aspect of CFTR protein dysfunction—a scientifically differentiated strategy from current therapies. Both lead NBD1 stabilizers (SION-451 and SION-719) have demonstrated encouraging safety profiles in Phase 1 trials, with no serious adverse events, no liver function concerns, and achievement of target exposures predicted to provide clinical benefit based on their preclinical models.
Their strategic acquisition of three clinical-stage assets from AbbVie for
While R&D expenses increased to
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
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 interim Phase 1 data evaluated 225 mg and 25 mg (fed) of SION-451 and 160 mg of SION-719, dosed twice daily (BID) over 10 days. The final MAD cohort for SION-719 will evaluate 120 mg BID. All MAD data, including from the recently completed cohorts, remain blinded to individual subject treatment assignment. Both compounds were generally well tolerated in these additional completed cohorts. There were no serious adverse events (SAEs), and most treatment emergent adverse events (TEAEs) were mild to moderate. There were no TEAEs related to liver function tests and no TEAEs that led to discontinuation of trial drug. Part C of both trials, in which Sionna is evaluating the effect of food on the pharmacokinetics (PK) of each product candidate and the bioequivalence of a tablet formulation is ongoing. Topline data from both trials are expected in the first half of 2025.
- Encouraging Phase 1 Interim Data: Sionna previously reported encouraging Phase 1 interim data from the completed SAD part and three cohorts of the MAD part of each Phase 1 trial of SION-719 and SION-451 in healthy subjects. As of the data cutoff date of January 14, 2025, both SION-719 and SION-451 were generally well tolerated at all administered dose levels, achieving target exposures 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 Sionna’s complementary modulators or as an add-on to the current standard of care (SOC).
- Phase 2a Proof-of-Concept Trial: Sionna plans to initiate a Phase 2a POC trial in the second half of 2025, after completion of a drug-drug interaction trial, to evaluate an NBD1 stabilizer in combination with the current SOC in CF patients. Topline data from this trial are anticipated in mid-2026.
- Combination MAD Trials: Sionna plans to initiate combination MAD trials in the second half of 2025, evaluating dual combinations of an NBD1 stabilizer with galifactor (SION-2222), a transmembrane domain 1 (TMD1)-directed CFTR corrector and/or SION-109, an intracellular loop 4 (ICL4)-directed CFTR corrector, in healthy subjects. Topline data are expected in mid-2026.
Complementary Modulators
- Successful Completion of Phase 1 Trial for SION-109: In December 2024, Sionna completed a Phase 1 clinical trial of SION-109 in healthy subjects. SION-109 was generally well tolerated at all dose levels administered and its target exposure as part of a dual combination with SION-451 or SION-719 was achieved with both single and multiple doses.
Business Highlights
- Completion of Upsized IPO: In February 2025, Sionna completed its upsized IPO, raising approximately
$219 million gross proceeds before deducting underwriting discounts and commissions and other expenses. Sionna issued 12,176,467 shares of its common stock at a public offering price of$18.00 per share, which included 1,588,234 shares issued upon the full exercise by the underwriters of their option to purchase additional shares of common stock in the offering. Shares began trading on the Nasdaq Global Market on February 7, 2025, under the symbol “SION.” - Strengthened Leadership: Sionna enhanced its Board of Directors with the appointments of Laurie Stelzer, Marcella Kuhlman Ruddy, M.D., and Jo Viney, Ph.D., who collectively bring decades of leadership experience in the biopharmaceutical industry, further supporting Sionna’s strategic growth and innovation.
Financial Results for the Quarter and Year Ended December 31, 2024
Research and Development Expenses: Research and development expenses were
General and Administrative Expenses: General and administrative expenses were
Net Loss: Net loss was
Cash and Cash Equivalents: Cash, cash equivalents and marketable securities totaled
About Sionna Therapeutics
Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (NBD1), which Sionna believes is central to potentially unlocking dramatic improvements in clinical outcomes and quality of life for people with CF. Leveraging more than a decade of the co-founders’ research on NBD1, Sionna is advancing a pipeline of small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function. For more information about Sionna, visit www.sionnatx.com.
Sionna intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Sionna’s beliefs and expectations regarding: the initiation, timing, progress and results of Sionna’s research and development programs, preclinical studies and clinical trials, including the timing of Phase 1 topline data for SION-719 and SION-451, and the planned initiation of combination MAD trials and a Phase 2a POC trial; the ability of clinical trials to demonstrate safety and efficacy of Sionna’s product candidates; the ability of Sionna’s preclinical studies to predict later clinical trial results; financial projections and expectations regarding the time period in which Sionna’s capital resources will be sufficient to fund its anticipated operations, including cash runway, use of capital, expenses and other financial results; and other statements that are not historical facts. In some cases, the forward-looking statements can be identified by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties inherent in the development of product candidates, including uncertainties concerning the initiation, timing, progress, and results of our planned and future clinical trials and studies; our ability to replicate positive results from earlier preclinical studies or clinical trials in current or future clinical trials; our ability to demonstrate that our NBD1 stabilizers, complementary CFTR modulators, and any potential future product candidates are safe and effective for their proposed indications; regulatory developments in the United States and foreign countries; and general economic, industry and market conditions. These risks and uncertainties are described in the section entitled “Risk Factors” in Sionna’s most recent Annual Report on Form 10-K as well as any subsequent filings with the Securities and Exchange Commission. The events and circumstances reflected in the forward-looking statements may not be achieved or occur. In addition, any forward-looking statements represent Sionna’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Sionna explicitly disclaims any obligation to update any forward-looking statements except as required by law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Media Contact
Adam Daley
CG Life
212.253.8881
adaley@cglife.com
Investor Contact
Juliet Labadorf
ir@sionnatx.com
| Sionna Therapeutics, Inc. Consolidated Statements of Operations (In thousands, except per share data) (unaudited) | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 14,254 | $ | 9,891 | $ | 57,288 | $ | 40,626 | |||||||
| General and administrative | 3,880 | 2,705 | 13,268 | 9,707 | |||||||||||
| Total operating expenses | 18,134 | 12,596 | 70,556 | 50,333 | |||||||||||
| Loss from operations | (18,134 | ) | (12,596 | ) | (70,556 | ) | (50,333 | ) | |||||||
| Other income: | |||||||||||||||
| Interest income | 2,119 | 554 | 8,170 | 2,769 | |||||||||||
| Other income | 167 | 166 | 698 | 301 | |||||||||||
| Total other income | 2,286 | 720 | 8,868 | 3,070 | |||||||||||
| Net loss | $ | (15,848 | ) | $ | (11,876 | ) | $ | (61,688 | ) | $ | (47,263 | ) | |||
| Net loss per share, basic and diluted | $ | (3.38 | ) | $ | (3.93 | ) | $ | (15.99 | ) | $ | (16.11 | ) | |||
| Weighted-average common shares outstanding, basic and diluted | 4,691,141 | 3,024,701 | 3,858,859 | 2,933,218 | |||||||||||
| Sionna Therapeutics, Inc. Selected Consolidated Balance Sheet Data (In thousands) (Unaudited) | |||||||
| December 31, 2024 | December 31, 2023 | ||||||
| Cash, cash equivalents, and marketable securities | $ | 168,043 | $ | 38,521 | |||
| Working capital1 | 140,573 | 31,170 | |||||
| Total assets | 185,752 | 51,945 | |||||
| Total stockholders’ deficit | (163,713 | ) | (114,881 | ) | |||
| 1Sionna defines working capital as current assets minus current liabilities. | |||||||
FAQ
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