On January 25, 2021 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported its financial results for the fiscal year ended October 31, 2020 and provides a business update (Press release, Advaxis, JAN 25, 2021, View Source [SID1234574249]).
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Fiscal Year 2020 and Recent Key Accomplishments:
Presented updated clinical data from the ongoing Phase 1/2 trial of ADXS-503 as a monotherapy and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in non-small cell lung cancer (NSCLC) at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting
In the Part B combination arm, reported disease control rate of 67% and overall response rate of 17% in first six evaluable patients with immediate prior progression on KEYTRUDA
Reported durable and sustained tumor control, with confirmed stable disease and a partial response lasting out to 10 months
Biomarker data across 9 patients across trial arms confirmed on-mechanism activation of innate and adaptive immune responses to ADXS-503 with activation of cytotoxic -and/or memory CD8+ T cells as well as 100% efficient priming by ADXS-503
Across trial arms, ADXS-503 appeared safe and well tolerated as a monotherapy and in combination with KEYTRUDA with no added toxicities from combination therapy
Initiated ADXS-503 Part B combination arm efficacy expansion which will enroll up to 15 patients to evaluate the potential of ADXS-503 in combination with KEYTRUDA to restore and/or enhance responsiveness to checkpoint inhibitors in PD-1/L-1 refractory NSCLC patients
Initiated ADXS-503 Part C combination arm to evaluate ADXS-503 in combination with KEYTRUDA as a first line treatment in patients with metastatic NSCLC that would receive KEYTRUDA alone as per label indication with PD-L1 expression ≥ 1% or who are unfit to receive the standard of care regimen of KEYTRUDA in combination with platinum based-chemotherapy
Announced FDA Clearance of new Investigational New Drug (IND) application for ADXS-504 for the treatment of prostate cancer at a leading medical institution
Announced common stock purchase agreement for up to $20 million of common stock with Lincoln Park Capital
Announced an at-the-market offering program for up to $40 million of common stock with A.G.P./Alliance Global Partners, as sales agent
Announced closing of $9.2 million public offering of common stock and warrants, with proceeds being used to fund continued development and expansion of our product pipeline, including investment in our ADXS-HOT program and for general corporate purposes
Cash runway currently anticipated to take the Company into fiscal second quarter of 2022
Management Commentary
"Fiscal year 2020 was transformative for Advaxis, with important clinical and biomarker data from the ongoing Phase 1/2 study of ADXS-503 in NSCLC which now consistently show the potential of ADXS-503 to synergistically enhance and/or restore sensitivity to checkpoint inhibitors," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Based on these encouraging results, we have prioritized this study, beginning enrollment in the expansion of Part B to further evaluate the promising signals of sustained clinical benefit observed in Part B in NSCLC patients with immediate prior progression on KEYTRUDA, as well as Part C, which will evaluate ADXS-503 in combination with KEYTRUDA in the first line setting. We remain confident that our clinical strategy will explore the full potential of ADXS-503 to improve responses to checkpoint inhibitors across diverse clinical settings and patient populations, and are highly enthusiastic about the on-mechanism innate and adaptive immune stimulation seen in our broadly accessible, off-the-shelf neoantigen immunotherapy. In addition to these encouraging data, our strengthened balance sheet ensures our continued momentum with the ADXS-HOT program as we advance our Lm-technology to expand the reach of checkpoint inhibitors."
Balance Sheet Highlights
As of October 31, 2020, Advaxis had cash and cash equivalents of $25.2 million. The Company used $21.9 million in cash to fund operations during fiscal year 2020, mainly attributed to funding research and development and general and administrative activities. Throughout fiscal year 2020, the Company continued to prioritize its strategic pipeline across all programs and reduced its annual operating expenses by approximately $12.2 million, or nearly 31%.
Fiscal Year 2020 Financial Information
Research and development expenses for fiscal year 2020 were $15.6 million, compared with $26.7 million for fiscal year 2019. The $11.1 million decrease was primarily attributable to decreases in clinical trial costs, laboratory costs, drug manufacturing process validation and drug stability studies.
General and administrative expenses for fiscal year 2020 were $11.1 million, compared to $12.2 million for fiscal year 2019.
The net loss for the fiscal year ended October 31, 2020 was $26.5 million or $0.43 per share based on about 61 million weighted average shares outstanding. This compares with a net loss for fiscal year 2019 of $16.6 million or $1.09 per share based on 15.2 million weighted average shares outstanding.