On June 14, 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 second quarter ended April 30, 2021 and provides a business update (Press release, Advaxis, JUN 14, 2021, View Source [SID1234583949]).
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Second Quarter Ended April 30, 2021 Financial Results 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 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting
10 patients have been treated with ADXS-503 as an add on therapy in patients failing pembrolizumab as last therapy with 10 patients evaluable for safety and 9 patients evaluable for efficacy
Combination therapy was well tolerated with no dose-limiting toxicities (DLTs) or added toxicity of the two drugs
The disease control rate (DCR) was 44% (4/9) with durable clinical benefit observed including a partial response (PR) and stable disease (SD) sustained for over a year, and another observed SD lasting over 6 months. An additional PR was maintained for approximately 4 months
Biomarker data demonstrate that patients who seem to achieve clinical benefit include those with PD-L1 expression ≥50%, secondary resistance disease to pembrolizumab and those who show proliferation and/or activation of NK and CD8+ T cells within the first weeks of therapy
Translational studies show antitumoral T-cell responses elicited against hot-spot mutation antigens and/or tumor associated antigens (TAAs), induction of proliferation and/or activation of pre-existing CD8+ T-cell clones, emergence of naive CD8+ T cell clones, and PD-1 and CD38 upregulation
Continuing to enroll patients for treatment with ADXS-503 in combination with KEYTRUDA (pembrolizumab) as first line therapy as well
Presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual meeting, in collaboration with Precision for Medicine, on the development of a novel immunophenotyping assay to accurately evaluate PD-1 expression as a pharmacodynamic marker during PD-1 blockade treatment with pembrolizumab, and the correlation of changes in T cell populations with observed clinical activity in the ongoing ADXS-503 clinical trial
Announced agreement with Columbia University Irving Medical Center to fund Phase 1 Study of ADXS-504 for the treatment of early prostate cancer with biochemical recurrence
Achieved second milestone under ADXS-HER2 licensing agreement with OS Therapies
Announced $20 million registered direct offering and concurrent private placement priced at-the-market with two healthcare-focused institutional investors to fund continued development and expansion of the Company’s product pipeline
Cash balance at April 30, 2021 of $48.1 million providing the Company with an anticipated cash runaway into fiscal 3rd quarter of 2023.
Management Commentary
"Our recent presentation at ASCO (Free ASCO Whitepaper) adds to the strong foundation of data which suggest treatment with ADXS-503 has the potential provide durable clinical benefit in patients with certain clinical characteristics and early T cell responses," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Achieving clinical benefit in patients with immediate prior progression on KEYTRUDA is particularly meaningful, suggesting that ADXS-503 has the potential to enhance and/or restore sensitivity to checkpoint inhibitors. These encouraging data, combined with our expanded set of translational data which show on-mechanism innate and adaptive immune stimulation, leave us confident that our off-the-shelf neoantigen immunotherapy may be an important new treatment option to expand the reach of immunotherapies in diverse treatment settings and indications. We will continue our progress with ADXS-503 in NSCLC and will expand our ADXS-HOT program to additional indications, with our planned study of ADXS-504 in early stage prostate cancer, and look forward to providing additional study updates in the coming months."
Second Quarter Ended April 30, 2021 Financial Results
Research and development expenses for the second quarter of fiscal year 2021 were $4.34 million, compared with $3.92 for the second quarter of fiscal year 2020. The increase of $0.42 million was primarily attributable to winding down some legacy studies and losses on disposal of research-related property and equipment in connection with the termination of the office lease at the Company’s former location.
General and administrative expenses for the three months ended April 30, 2021 were at $3.35 million, compared to $2.65 million in the same three-month period in fiscal 2020. The increase of $0.7 million primarily relates to increases in sub-license fees and legal fees, amounts paid in settlement of shareholder demand letters and losses on disposal of other property and equipment in connection with the termination of the Company’s office lease at its former location.
As of April 30, 2021, the Company had approximately $48.1 million in cash and cash equivalents. The Company believes this is sufficient capital to fund its obligations, as they become due, in the ordinary course of business into the 3rd fiscal quarter of 2023.