On January 10, 2019 Advaxis, Inc. (NASDAQ: ADXS) (the Company), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported its financial results for the fiscal year ended October 31, 2018 and provides a business update (Press release, Advaxis, JAN 10, 2019, View Source [SID1234532616]).
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Fiscal Year 2018 and Recent Key Accomplishments
Received U.S. Food and Drug Administration allowance of the Investigational New Drug application for the Company’s first ADXS-HOT off-the-shelf neoantigen drug candidate, ADXS-503, for the treatment of all types of non-small cell lung cancer;
Dosed the first patients in the ADXS-NEO Phase 1 dose-escalation study in patients with several solid tumor types;
Raised gross proceeds totaling approximately $40 million from an underwritten public offering of common stock and an underwritten public offering of common stock and warrants;
Appointed a permanent chief executive officer, Kenneth A. Berlin, a new chief medical officer, Andres Gutierrez, M.D., and a new chief financial officer, Molly Henderson;
Licensed ADXS-HER2 to OS Therapies for evaluation in the treatment of pediatric osteosarcoma;
Significantly reduced annual net cash usage through a prioritization of programs and assets; and
Presented and published data from several preclinical and clinical trials with the Company’s drug candidates.
Management Commentary
"Fiscal 2018 was an eventful year for Advaxis as we worked to reorganize the company, prioritize our pipeline and define a strategic direction that supports our mission to improve the lives of people suffering from cancer and their loved ones," said Kenneth A. Berlin, president and chief executive officer of Advaxis. "Our diverse pipeline of drug candidates and constructs at various stages of development is based on our proprietary Lm platform, which has a significant safety database from first-generation constructs already tested in humans."
Mr. Berlin added, "We are dosing patients under our ADXS-NEO program and anticipate the first patient to be enrolled in our ADXS-503 study within the next several weeks. These are significant accomplishments for the Company and we’re excited to start to see early correlative and safety data from these neoantigen programs during the first half of 2019."
Mr. Berlin continued, "During the second half of fiscal year 2018 we took steps to significantly reduce our cash burn and align our spending in keeping with a company our size. We are committed to advancing our various clinical programs as rapidly and cost effectively as possible throughout fiscal year 2019. We also continue to evaluate opportunities for partnerships and collaborations across all of our programs, and anticipate several catalysts for the Company in 2019. We remain committed to demonstrating that the drug candidates emanating from our Lm platform have the potential to positively impact people with cancer," Mr. Berlin concluded.
Balance Sheet Highlights
As of October 31, 2018, Advaxis had cash and cash equivalents of $44.1 million. The Company used $62.1 million in cash to fund operations during fiscal 2018, mainly attributed to funding research and development and general and administrative activities. Throughout fiscal 2018, the Company completed an in-depth review of all programs and cash expenditures, and reduced its net annual cash usage to approximately $50 million.
Fiscal Year 2018 Financial Information
Research and development expenses for fiscal 2018 were $57.0 million, compared with $70.5 million for fiscal 2017. The $13.5 million decrease was primarily attributable to a decrease in laboratory costs, drug manufacturing process validation and drug stability studies.
General and administrative expenses for fiscal 2018 were $19.5 million, compared with $40.0 million for fiscal 2017. The $20.5 million decrease was primarily attributable to an $18.0 million decrease in stock-based compensation expense.
The net loss for the fiscal year ended October 31, 2018 was $66.5 million or $1.29 per share based on 51.5 million weighted average shares outstanding. This compares with a net loss for fiscal 2017 of $93.4 million or $2.31 per share based on 40.5 million weighted average shares outstanding.
Conference Call and Webcast Information
Advaxis’ senior management will host a conference call to review financial results, provide a business update and answer questions at 11:00 a.m. Eastern time on Tuesday, January 15, 2019.
To access the conference call please dial (844) 348-6133 for domestic callers or (631) 485-4564 for international callers. A live and archived audio webcast of the call will be available on the Company’s website at www.ir.advaxis.com/news-events.
A recording will be available beginning two hours after the call ends by dialing (855) 859-2056 for domestic callers or (404) 537-3406 for international callers and providing conference ID 4862946.