SION — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-12

• We believe our robust pipeline provides multiple potential pathways to achieve our mission, either through development of an NBD1 stabilizer and a complementary modulator in combination with each other to produce a proprietary dual combination, or an NBD1 stabilizer administered in combination with …

• Since our inception, we have funded our operations primarily with proceeds from private placements of convertible preferred stock and through net proceeds from our initial public offering. In March 2026, we entered into a sales agreement with Leerink Partners LLC (“Leerink”), to issue and sell share…

• Due to our significant research, development and manufacturing expenditures, we have accumulated substantial losses and negative cash flows since our inception, including net losses of $26.8 million and $16.5 million for the three months ended March 31, 2026, and 2025, respectively. As of March 31, …

• rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

• business in the future. We may never obtain regulatory approval for any of our product candidates, and, even if we do, drug commercialization takes several years and millions of dollars in development costs.

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• We believe our robust pipeline of NBD1 stabilizers and complementary CFTR modulators provide multiple potential pathways to achieving our goal, either in combination with each other to produce a proprietary dual combination CF therapy, or an NBD1 stabilizer in combination with the current standard o…

• Our portfolio of complementary CFTR modulator candidates are designed to work synergistically with our NBD1 stabilizers to improve CFTR function, as seen in preclinical models. During 2024, we in-licensed three clinical-stage compounds from AbbVie Global Enterprises Ltd. (“AbbVie”) to expand our por…

• We currently have exclusive rights to develop and commercialize our compounds.

• Since our inception in 2019, we have not generated any revenue. We have historically funded our operations primarily with proceeds from the sale and issuance of our preferred stock. As of September 30, 2025, we raised aggregate net proceeds of $330.4 million from the sale and issuance of our preferr…

• Due to our significant research, development and manufacturing expenditures, we have accumulated substantial losses and negative cash flows since our inception, including net losses of $54.8 million and $45.8 million for the nine months ended September 30, 2025, and 2024, respectively. As of Septemb…

Text added vs the prior filing · source: 10-Q · 2026-05-12

• •the scope, timing, progress, costs, complexity and results of discovery, preclinical development and clinical trials for our current or future product candidates, including any additional expenses attributable to adjusting our anticipated development plans;

• •the availability of drug substance and drug product for use in production of our product candidates;

• •the impact of competition with other products approved for the treatment of CF and product candidates in development for the treatment of CF; and

• For example, either the combination of our product candidates with each other, or an NBD1 stabilizer with the standard of care, may result in adverse side effects or toxicities that the product candidates or other

• therapy do not produce when used alone. In addition, the product candidates may interact with each other, or with the approved product, in undesirable ways that could negatively impact the efficacy of our product candidates, any components of the approved product, or the combination as a whole. Test…

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• •the scope, timing, progress, costs, complexity and results of discovery, preclinical development and clinical trials for our current or future product candidates, including our ongoing Phase 2a proof-of-concept clinical trial to evaluate SION-719 in combination with Vertex Pharmaceuticals, Inc.'s (…

• Our assumptions about the development potential of SION-719 and SION-451 are based entirely on the data generated from our Phase 1 clinical trials of SION-719 and SION-451 in healthy subjects and from preclinical studies. We have not, as a company, completed any clinical trials of our product candid…

• For example, either the combination of our product candidates with each other, or an NBD1 stabilizer with the standard of care, may result in adverse side effects or toxicities that the product candidates or other therapy do not produce when used alone. In addition, the product candidates may intera…

• adverse effects or failed clinical trials. The timing, outcome and cost of developing products to be used in combination with other therapies is difficult to predict and dependent on a number of factors that are outside our reasonable control.

• In addition, to the extent we choose to develop and commercialize a product candidate for use in combination with an approved therapy, any safety, efficacy, regulatory, manufacturing or supply issues that could arise with respect to the approved therapy could have an adverse impact on us. Prescribin…

Text added vs the prior filing · source: 10-Q · 2026-05-12

• (1) A trading arrangement may expire on an earlier date if all contemplated transactions are completed before such trading arrangement's expiration date, upon termination by broker or the holder of the trading arrangement, or as otherwise provided in the trading arrangement.