ACHV — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-11

• We believe we will be able to commercialize independently in the U.S. market by focusing our commercial efforts on areas where patient unmet needs are highest, while developing a framework to support broader adoption across payers, prescribers, and health systems. We are conducting market research t…

• including market access, medical education, patient advocacy and government affairs, trade, and customer strategy. Additionally, we are evaluating the use of field-based representatives to supplement digital promotional efforts.

• We have no products approved for commercial sale and have not generated any revenue from product sales to date. We have never been profitable and have incurred operating losses in each year since inception. Our net loss was $84.9 million for the six months ended June 30, 2026. As of June 30, 2026, w…

• Manufacturing costs for our product candidate, cytisinicline, are expensed as incurred as R&D expenses prior to regulatory approval.

• We manage our clinical trials through contract research organizations and independent medical investigators at our sites and at hospitals and expect this practice to continue. Due to our ability to utilize resources across several projects, we do not record or maintain information regarding the indi…

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

• We believe we will be able to commercialize independently in the U.S. market by focusing our marketing and sales efforts on highly targeted prescriber and patient audiences. We are planning to launch cytisinicline by utilizing a well-established marketing technology infrastructure and embedding Arti…

• established for key functional areas including market access, medical education, prescriber and patient marketing, and digital infrastructure. Additionally, field-based and virtual sales representatives will supplement digital promotional efforts.

• We have no products approved for commercial sale and have not generated any revenue from product sales to date. We have never been profitable and have incurred operating losses in each year since inception. Our net loss was $10.2 million for the three months ended March 31, 2026. As of March 31, 202…

• We manage our clinical trials through contract research organizations and independent medical investigators at our sites and at hospitals and expect this practice to continue. Due to our ability to utilize resources across several projects, we do not record or maintain information regarding the indi…

• we believe that allocating costs on the basis of time incurred by our employees does not accurately reflect the actual costs of a project.

Text added vs the prior filing · source: 10-Q · 2026-08-11

• The current financing environment in the United States, particularly for biotechnology companies like us, is challenging and we can provide no assurances as to when this will improve. Our business may be impacted by macroeconomic conditions, including fluctuating inflation, interest and tariff rates…

• and other geopolitical events and uncertainties beyond our control. Supply chain disruptions and delays as a result of any new tariff policies or trade restrictions could also negatively impact our cost of materials and production processes. For example, the United States has announced tariffs on ma…

• Our obligations under our outstanding debt are secured by substantially all of our assets, other than intellectual property. If we are unable to make payment on our secured debt instruments when due, the lender under such instrument may foreclose on and sell the assets securing such indebtedness to …

• business and conducting our business as planned, which could materially harm our financial condition and results of operations. Further, if we are liquidated, the rights of the Lender to repayment would be senior to the rights of the holders of our common stock to receive any proceeds from the liqui…

• Our planned NDA resubmission following receipt of a CRL citing deficiencies at a third-party manufacturing facility may be delayed, may not adequately address the FDA's concerns, or may not result in approval on the timeline we expect, or at all.

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

• The current financing environment in the United States, particularly for biotechnology companies like us, is challenging and we can provide no assurances as to when this will improve. Our business may be impacted by macroeconomic conditions, including fluctuating inflation, interest and tariff rates…

• Our obligations under our outstanding debt are secured by substantially all of our assets, other than intellectual property. If we are unable to make payment on our secured debt instruments when due, the lender under such instrument may foreclose on and sell the assets securing such indebtedness to …

• The use or misuse of cytisinicline in clinical trials and the sale of cytisinicline if marketing approval is obtained, exposes us to the risk of potential product liability claims. Product liability claims might be brought against us by consumers, healthcare providers,

• pharmaceutical companies or others selling or otherwise coming into contact with our product. There is a risk that cytisinicline may induce adverse events. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs.

• government agencies. These initiatives could prevent, limit or delay development and regulatory approval of our product candidates, which would adversely affect our business.