ALMS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-14

• We are a clinical stage biopharmaceutical company with an initial focus on developing our two Tyrosine Kinase 2 (“TYK2”) inhibitors: envu, a second-generation inhibitor that we are developing to maximize target inhibition and optimize tolerability, and A-005, a central nervous system (“CNS”) penetra…

• We have incurred significant operating losses and negative cash flows since our inception. Our net loss for the three months ended March 31, 2026 and 2025 was $93.1 million and $99.0 million, respectively. As of March 31, 2026, we had an accumulated deficit of $994.9 million.

• Substantially all of our net losses have resulted from costs incurred in connection with our research and development efforts, including acquisitions of in-process research and development assets, and, to a lesser extent, from general and

• administrative costs associated with our operations. Our net losses and operating losses may fluctuate from quarter to quarter and year to year depending primarily on the timing of acquisition of any new product candidates, the timing of our preclinical studies and clinical trials, our other researc…

• ●prepare to submit an NDA for envu in PsO in the second half of 2026, including as we conduct activities, including CMC activities, that are required to complete our planned NDA submission;

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• We are a clinical stage biopharmaceutical company with an initial focus on developing our two Tyrosine Kinase 2 (“TYK2”) inhibitors: envudeucitinib (or “envu”), formerly known as ESK-001, a second-generation inhibitor that we are developing to maximize target inhibition and optimize tolerability, an…

• To date, we have primarily funded our operations primarily through issuance of common stock, including in our IPO and Concurrent Private Placement, the issuance of redeemable convertible preferred stock and convertible promissory notes in private placements and, most recently, the acquisition of cas…

• We have incurred significant operating losses and negative cash flows since our inception. Our net loss for the three and nine months ended September 30, 2025 and 2024 was $110.8 million, $93.1 million, $150.4 million and $199.5 million, respectively. As of September 30, 2025, we had an accumulated …

• ●continue committing substantial capital resources to the integration and development activities related to the acquired ACELYRIN business;

• We do not have any products approved for sale and have not generated any revenue from product sales since our inception. We do not expect to generate revenue from any product candidates that we develop until we obtain regulatory approval for one or more of such product candidates and commercialize o…

Text added vs the prior filing · source: 10-Q · 2026-05-14

• ●Enrollment and retention of participants in clinical trials is an expensive and time-consuming process and could

• be made more difficult or rendered impossible by multiple factors outside our control, including difficulties in identifying patients, the availability of competitive products and significant competition for recruiting participants in clinical trials.

• ●Even if we receive regulatory approval for our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally,

• our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal. We may also be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.

• ●We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, rules; contractual obligations; policies; and other obligations related to data privacy and security. Our (including the third parties with whom we work) actual or perceived failure …

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• ●Enrollment and retention of participants in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, including difficulties in identifying patients, the availability of competitive products and signif…

• ●We are subject to various risks related to the acquisition of ACELYRIN.

• ●Even if we receive regulatory approval for our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other rest…

• ●We may have conflicts with any current or future licensors or collaborators that could delay or prevent the development or commercialization of our product candidates.

• We have and will continue to incur significant development and other expenses related to our research and clinical development programs and ongoing operations. For the three and nine months ended September 30, 2025, our net loss was $110.8 million and $150.4 million, respectively. As of September 30…