On February 14, 2022 Advaxis, Inc. (OTCQX: 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, 2021 and provides a business update (Press release, Advaxis, FEB 14, 2022, View Source [SID1234608068]).
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Fiscal Year 2021 and Recent Key Accomplishments:
Presented updated clinical data from ongoing Phase 1/2 Trial of ADXS-503 in NSCLC
In Part B combination arm
a second partial response was observed
overall response rate was 15% and disease control rate was 46%
In Part C combination arm in newly diagnosed subjects
disease control rate of 67% was observed
Initiated Phase 1 trial of ADXS-504 for the treatment of early prostate cancer
Management Commentary
"Fiscal year 2021 was a busy year 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. "We are executing on 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. Major milestones for the ADXS-503 trial in the second half of 2022 include updated clinical and immunogenicity data for all patients in Stage 1 in Part B and from up to 10 patients in Part C. Also, initial clinical and immunogenicity data from the ADXS-504 trial in early prostate cancer are expected to be reported in the second half of this year."
Mr. Berlin continued, "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. We 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, 2021, Advaxis had cash and cash equivalents of $41.6 million. The Company used $15.4 million in cash to fund operations during fiscal year 2021, mainly attributed to funding research and development and general and administrative activities. Throughout fiscal year 2021, the Company continued to prioritize its main ADXS-503 product candidate while winding down its legacy studies and reducing its annual operating expenses by approximately $4.7 million, or nearly 18%.
Fiscal Year 2021 Financial Information
Research and development expenses for fiscal year 2021 were $10.6 million, compared with $15.6 million for fiscal year 2020. The $5.0 million decrease was primarily attributable to decreases in clinical, laboratory and personnel costs as a result of the winding down of several legacy studies.
General and administrative expenses for fiscal year 2021 were $11.5 million, compared to $11.1 million for fiscal year 2020.
The net loss for the fiscal year ended October 31, 2021 was $17.9 million or $0.14 per share based on approximately 129 million weighted average shares outstanding. This compares with a net loss for fiscal year 2020 of $26.5 million or $0.43 per share based on approximately 61 million weighted average shares outstanding.