On December 20, 2019 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, 2019 and provides a business update (Press release, Advaxis, DEC 20, 2019, View Source [SID1234552551]).

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Fiscal Year 2019 and Recent Key Accomplishments

●Completed enrollment in the first and second dose levels in Part A of the ongoing Phase 1/2 trial evaluating ADXS-503, the Company’s ADXS-HOT drug candidate in non-small cell lung cancer, with immune response data anticipated in early 2020.
●Completed manufacturing of ADXS-506, the Company’s ADXS-HOT drug candidate for bladder cancer, enabling future potential clinical development.
●Reported early immune response data from the Phase 1 ADXS-NEO study demonstrating the generation of CD8+ T cells against hotspot neoantigen mutations. These results serve as an important proof-of-mechanism for the Company’s off-the-shelf ADXS-HOT program which targets common hotspot mutations found in tumors.
Announced updated overall survival from the KEYNOTE-046 Phase 1/2 trial evaluating ADXS-PSA in combination with KEYTRUDA in metastatic castrate resistant prostate cancer. Median overall survival increased to 33.6 months from the previously reported 21.1 months.
● Entered collaborative research agreement with University of California, Los Angeles to investigate anti-tumor immunity and responses generated by Lm vaccines targeting glioblastoma neoantigens.
●Continued pipeline prioritization efforts enabling the reduction of operating expenses and extension of cash runway into early 2021.

Management Commentary

"Fiscal year 2019 has been marked with continued progress in the strategic advancement of our most promising clinical programs," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "With encouraging clinical proof-of-concept data, we are focused on developing and expanding our off-the-shelf neoantigen program, ADXS-HOT, and look forward to sharing immunogenicity data in early 2020. In addition, the announcement of significant improvements in overall survival from our KEYNOTE-046 study in prostate cancer further bolsters our confidence in the power of our Lm technology to improve patient outcomes and potentially shift the immunotherapy treatment paradigm. These promising data, in combination with our successful efforts to reduce cash burn and increase efficiencies, leave us positioned to execute on our innovative immunotherapy clinical pipeline."

Balance Sheet Highlights

As of October 31, 2019, Advaxis had cash and cash equivalents of $32.4 million. The Company used $36.1 million in cash to fund operations during fiscal year 2019, mainly attributed to funding research and development and general and administrative activities. Throughout fiscal year 2019, the Company continued a strategic pipeline prioritization across all programs and reduced its annual expenses by approximately $37.6 million, or nearly 50%.

Fiscal Year 2019 Financial Information

Research and development expenses for fiscal year 2019 were $26.7 million, compared with $57.0 million for fiscal year 2018. The $30.3 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 2019 were $12.2 million, compared to $19.5 million for fiscal year 2018. The $7.3 million decrease was primarily attributable to the institution of control cost measures for non-essential items in areas that did not support the strategic direction of the Company, as well as a reduction in external costs associated with strategy, business consulting and regulatory in fiscal year 2018 that did not recur in fiscal year 2019.

The net loss for the fiscal year ended October 31, 2019 was $16.6 million or $1.09 per share based on 15.2 million weighted average shares outstanding. This compares with a net loss for fiscal year 2018 of $66.5 million or $19.36 per share based on 3.4 million weighted average shares outstanding.