This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
2/9/2026
Good morning, everyone, and welcome to the Anovex Life Sciences Fiscal 2026 First Quarter Conference Call. My name is Clint Tomlinson, and I will be your host for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and during this session, if you would like to ask a question, please use the Q&A box or raise your hand. Please note this conference is being recorded, and the call will be available on Anavex's website at www.anavex.com. With us today is Dr. Christopher Missling, President and Chief Executive Officer, and Sondra Burnish, Principal Financial Officer. Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. We encourage you to review the company's filings with the SEC, and this includes, without limitation, the company's forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include without limitation risks inherent in the development and or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. This conference call discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such products will successfully complete clinical development or gain health authority approval. And with that, I would like to turn the call over to Dr. Misling.
Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our first quarter financial results and quarterly business update. As we enter 2026, we continue to progress our innovative clinical pipeline with particular focus on our lead candidate, oral Blakarmazine in early Alzheimer disease. Based on our commitment to improving the lives of patients with neurological disorders, we remain excited about the therapeutic potential of oral Blakarmazine. We look forward to working with the regulatory agencies in Europe and in the US to advance Blacarmazine as a potential new treatment option for patients. We recently announced Anavec's participation as a key industry partner in AccessAD. a major new European initiative designed to accelerate the adoption of innovative diagnostic and therapeutic approaches for Alzheimer's disease across real-world clinical settings. The multi-year program is funded by the European Commission's Innovative Health Initiative and unites leading academic centers, technology developers, industry innovators, and patient organizations to strengthen equitable access to timely and effective Alzheimer's disease care. As part of the consortium, Blacarmazine will be evaluated in a clinical prediction study. As an update to our regulatory pathway, in January we announced feedback from an FDA Type C meeting, in which the FDA shared their feedback to Anavex development plans. The meeting discussed the potential pathways to support Blacarmazine for Alzheimer's disease. In order to move forward, it is expected that existing data from the Phase 2b-3 ANAVEX 273-80-054 program will be submitted to the FDA. In December, as expected, the CHMP adopted a negative opinion on the marketing authorization application for Blakarmese. Subsequently, on December 18, ANAVEX announced it had requested the EMA to re-examine its opinion. We are working closely with the EMA during this process, which is being led by a different rapporteur and co-rapporteur. In November, we announced presentations at the 18 CTET conference in San Diego. The Oral Late-Breaking Communication Oral Blacamycin Phase 2b-3 Trial confirms identified precision medicine patient population. significant broad clinical and quality of life improvements for early Alzheimer's disease patients and to post those presentations featuring Blacarmazine. Looking forward, we will provide both regulatory and clinical trial updates on Blacarmazine in other indications such as Parkinson's disease and Fragile X. This will include disclosure of planned future clinical trial designs as we continue to advance our therapeutic pipeline. Additionally, new scientific findings will be presented at upcoming conferences or in upcoming publications. an oral presentation at the 16th Intrinsic Capacity, Friality, and Sarcopenia Research Conference for Healthy Longevity to be held March 10 to 12 at Johns Hopkins University Bloomberg Center in Washington, D.C. New findings on a clinical relationship with a biomarker, correlation between clinical endpoints, and reduced brain region atrophy with black carmesine in early Alzheimer's disease. a publication on Alzheimer's disease regarding precision medicine, AB Clear Public Populations of the Advex 273AD004 Phase 2B-3 Trial. Another publication on Alzheimer's disease on the precision medicine gene collagen 24A1, which with an estimated over 70% prevalence in the early Alzheimer's disease population, which has the potential to establish effective treatment of early Alzheimer's disease through effectiveness of autophagy-enhancing belkarmazine. and a publication regarding Fragile X. Placarmazine corrects EEG biomarkers of cortical dysfunction in a mouse model of Fragile X syndrome. With regard to Anavex 371, we will be advancing Anavex 371 towards pivotal clinical studies for the treatment of schizophrenia-related disorders. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex, for a financial summary of the recently reported quarter.
Thanks, Christopher. Good morning to everyone. I am pleased to share with you today our first quarter financial results. Our cash position at December 31st was $131.7 million with no debt. During the quarter, we utilized cash and cash equivalents of 7.1 million in operating activities after taking into account changes in non-cash working capital accounts. As of today, we anticipate that at the current cash utilization rate, our cash runway is more than three years. Our research and development expenses for the quarter were 4.7 million as compared to 10.4 million for the comparable quarter of last year. General and administrative expenses were $2.1 million as compared to $3.1 million for the comparable quarter of last year. And compared to the same quarter of fiscal 2025, we saw a decrease in operating expenses, mostly driven by the completion of a large manufacturing campaign of Blark-Hamazine conducted in fiscal 2025, and a decrease in clinical trial activities as a result of the completion of our Anavex 371 Phase 2 study in schizophrenia. And lastly, we reported a net loss of $5.7 million for the quarter, or $0.06 per share. Thanks, and I'll turn it back to you, Christopher.
You're reading a preview of the AVXL Q1 2026 earnings call.
Free account.
