Sionna Therapeutics SION
Sionna Therapeutics reported a net loss of $32.42 million
Sionna Therapeutics (SION) filed a 10-Q with the SEC on Nov 10, 2026, 7:11 am ET. Source: the filing on SEC EDGAR.
Quarterly report, 10 new risk factors
- Form
- 10-Q
- Filed
- Importance
- Major
- Accession
- 0001628280-26-072499
- Net loss: $32.42 million for the three months ended Sep 30, 2026
- Diluted EPS: -$0.72 for the three months ended Sep 30, 2026
- Cash and equivalents: $83.88 million at Sep 30, 2026
Written from the 10-Q on EDGAR. AI can make mistakes. Check the filing.
What changed since last quarter
10 new risk factors · 9 removed
Compared with the 10-Q for the period ended Jun 30, 2026.
| This filing | Previous | Change vs prior 10-Q | |
|---|---|---|---|
| Operating income and margin | −$34.82M | −$32.47M | −7.2% |
| Net income | −$32.42M | −$29.89M | −8.5% |
| Operating cash flow | −$18.72M | −$22.22M | +16% |
| Cash | $83.88M | $63.32M | +33% |
New risk factors (10)
- We are substantially dependent on the success of our dual combination of SION-451 + SION-2222. If we are unable to advance SION-451 + SION-2222 into our planned proof-of-concept clinical trial or later-stage clinical development, or to obtain regulatory approval and commercialize a combination therapy of SION-451 +… +2 more paragraphs
- Further, we have conducted, and may in the future conduct, clinical trials of our current or future product candidates outside the United States. Conducting clinical trials in foreign countries presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled…
- The current treatment paradigm in CF for all patients with the F508del mutation is based on a combination of drug therapies. We expect to initiate the AscenSION CF Phase 2 proof-of-concept trial in CF patients in the first quarter of 2027. AscenSION CF will be an open-label trial evaluating people with CF who are… +1 more paragraph
- The historical failure rate for product candidates in our industry is high, particularly in the earlier stages of development. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily…
- •the number of patients required for clinical trials of our product candidates being larger than we anticipate; +2 more paragraphs
- and 5 more in the filing
Removed risk factors (9)
- We are substantially dependent on the success of at least one of our nucleotide binding domain 1 ("NBD1") stabilizers. If we are unable to advance an NBD1 stabilizer product candidate into later-stage clinical development or unable to obtain regulatory approval and commercialize an NBD1 stabilizer- anchored… +2 more paragraphs
- Further, conducting clinical trials in foreign countries, as we are currently doing and plan to do in the future for our current or future product candidates, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere…
- The current treatment paradigm in CF for all patients with the F508del mutation is based on a combination of drug therapies. We expect to report in the summer of 2026 topline data from a Phase 2a proof-of-concept trial in CF patients evaluating SION-719 in combination with the standard of care and a Phase 1 trial… +2 more paragraphs
- •the number of patients required for clinical trials of our product candidates being larger than we anticipate; enrollment in these clinical trials being slower than we anticipate, for example, due to the availability of standard of care therapy, changes to standard of care therapy, and the reluctance of patients to…
- For example, central to our pipeline prioritization strategy is our application of an in vitro electrophysiology assay to measure CFTR function in a CF model, known as the cystic fibrosis human bronchial epithelial ("CFHBE") model, which uses lung cells from CF patients and has been shown to be predictive of clinical…
- and 4 more in the filing