ADDED
o Yes x No The aggregate market value of the common stock of the registrant held by non-affiliates of the registrant as of June 30, 2025, the last business day of the registrant s second fiscal quarter, was $ 45.3 million.
These forward-looking statements include, but are not limited to, statements concerning the following: the sufficiency of our existing cash and cash equivalents and marketable securities to fund our future operating expenses and capital expenditure requirements; our ability to obtain funding for our operations, including funding necessary to develop and commercialize sabirnetug or any A oligomer-targeted Enhanced Brain Delivery, or EBD , product candidates that we may develop pursuant to our collaboration with JCR Pharmaceuticals Co.
We will require substantial additional funding to finance our operations, complete the development and commercialization of sabirnetug for Alzheimer s disease, or AD, and evaluate future product candidates, including any A oligomer-targeted EBD product candidates that we may develop pursuant to our collaboration with JCR.
Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report in our audited financial statements included in this Annual Report on Form 10-K.
If we are unable to obtain sufficient funding, our business, results of operations, financial condition and prospects may be adversely affected and we may be unable to continue as a going concern.
If we are unable to enter into a commercial collaboration or, alternatively, establish internal sales, marketing and distribution capabilities for sabirnetug or any other product candidate, including any A oligomer-targeted EBD product candidates that we may develop pursuant to our collaboration with JCR, that may receive regulatory approval, we may not be successful in commercializing those product candidates if and when they are approved.
We are currently focused on advancing a targeted immunotherapy drug candidate, sabirnetug (ACU193), in our Phase 2 ALTITUDE-AD clinical trial, and expect to announce top-line results in late 2026.
Sabirnetug is a recombinant humanized immunoglobulin gamma 2, or IgG2, monoclonal antibody, or mAb, that was designed to selectively target A Os, has demonstrated functional and protective effects in in vitro assays, and has demonstrated in vivo safety and pharmacologic activity in multiple animal species, including transgenic mouse models for AD, as well as in human AD patients in our Phase 1 INTERCEPT-AD clinical trial of sabirnetug, the results of which were announced in July 2023.
ALTITUDE-AD is a randomized, double-blind, placebo-controlled, three-arm clinical trial designed to evaluate the clinical efficacy, safety and tolerability of sabirnetug with up to 180 participants per arm for a total of 542 participants with mild cognitive impairment, or MCI, or mild dementia due to AD.
We plan to use the Integrated Alzheimer s Disease Rating Scale at 18 months as the primary outcome measure.
REMOVED
o Yes x No The aggregate market value of the common stock of the registrant held by non-affiliates of the registrant as of June 28, 2024, the last business day of the registrant s second fiscal quarter, was $ 97.5 million.
You should not rely on forward-looking statements as predictions of future events.
We will require substantial additional funding to finance our operations, complete the development and commercialization of sabirnetug for Alzheimer s disease, or AD, and evaluate future product candidates.
If we are unable to enter into a commercial collaboration or, alternatively, establish internal sales, marketing and distribution capabilities for sabirnetug or any other product candidate that may receive regulatory approval, we may not be successful in commercializing those product candidates if and when they are approved.
If we are unable to obtain and maintain sufficient intellectual property protection for sabirnetug and any future product candidate, and other proprietary technologies we develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product candidate, and other proprietary technologies if approved, may be adversely affected.
We are currently focused on advancing a targeted immunotherapy drug candidate, sabirnetug (ACU193), in our Phase 2 ALTITUDE-AD clinical trial following Phase 1 results in early AD patients (patients with mild cognitive impairment, or MCI, or mild dementia due to AD) that were reported in July 2023.
Sabirnetug is a recombinant humanized immunoglobulin gamma 2, or IgG2, monoclonal antibody, or mAb, that was designed to selectively target A Os, has demonstrated functional and protective effects in in vitro assays, and has demonstrated in vivo safety and pharmacologic activity in multiple animal species, including transgenic mouse models for AD.
In our nonclinical studies using an enzyme-linked immunosorbent assay, or ELISA assay, we observed that sabirnetug has over 500-fold greater selectivity for targeting A Os over A monomers and 87-fold selectivity for targeting A Os over A fibrils.
In 2024, we completed a nonclinical study using Surface Plasmon Resonance, or SPR, technology, which demonstrated that sabirnetug is 8750-fold more selective for A Os than A monomers.
We completed a Phase 1 clinical trial of sabirnetug in the second quarter of 2023, which we named INTERCEPT-AD.