On September 10, 2021 Advaxis, Inc., a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported its financial results for the third quarter ended July 31, 2021 and provides a business update (Press release, Advaxis, SEP 10, 2021, View Source [SID1234587528]).
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Third Quarter Ended July 31, 2021 Financial Results and Recent Key Accomplishments:
●Entered into a definitive merger agreement with Biosight Ltd. The proposed merger will create a public company, operating as Biosight Therapeutics, to advance a pipeline of clinical-stage oncology programs including Biosight’s lead product, aspacytarabine (BST-236). The combined company is expected to have approximately $50 million in cash, cash equivalents and marketable securities at closing. Following the closing, which is expected to occur in the 4th calendar quarter of 2021, Advaxis will be renamed Biosight Therapeutics and is expected to trade on the Nasdaq Capital Market under the ticker symbol "BSTX".
●The combined company anticipates the following milestones across the combined pipeline over the next 12-18 months:
○Topline results in 65 patients from the ongoing Phase 2 trial of aspacytarabine, which has completed enrolment, as first-line therapy in acute myeloid leukemia (AML) patients who are unfit for standard chemotherapy
■Recent data presented at 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showed that aspacytarabine alone achieved complete remission (CR) rates of 39% across all evaluable patients (n=46) with 63% of cases analyzed to date with negative minimal residual disease (MRD(-) and median duration of response not yet reached at 12 months. Altogether these results are encouraging considering the high-risk factors in this population at baseline;
○Initial results from the Phase 2 trial of aspacytarabine in collaboration with the European cooperative group, Groupe Francophone des Myélodysplasies (GFM) in patients with relapsed/refractory AML and higher-risk Myelodysplastic Syndrome (MDS);
○Initiation in the U.S. of a second, Phase 2 trial of aspacytarabine in patients with relapsed/refractory AML and higher-risk MDS;
○Results from the ongoing Phase 1/2 trial with ADXS-503 in combination with pembrolizumab in non-small cell lung cancer; and
○Initial results from the Phase 1 trial of ADXS-504 in biochemically recurrent prostate cancer
●Initiated Phase 1 clinical trial of ADXS-504 being conducted at Columbia University Irving Medical Center for the treatment of biochemically recurrent prostate cancer, expanding the off-the-shelf ADXS-HOT program to a second indication
●Presented updated clinical data from Part B of the ongoing Phase 1/2 trial of ADXS-503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in non-small cell lung cancer (NSCLC) at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting; data presented from the Part B arm of this study, demonstrate a disease control rate of 44%, 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 SD was maintained for approximately 4 months. Translational and biomarker results demonstrate on-mechanism immune activation tied to clinical benefit
●Presented data from Part B of the ongoing Phase 1/2 study of ADXS-503 in combination with KEYTRUDA (pembrolizumab) at the Non-Small Cell Lung Cancer Drug Development Summit
●Announced Nasdaq extension, to November 22, 2021, to regain compliance with the $1.00 minimum bid price rule and complete merger transaction with Biosight, Ltd.
●Cash balance at July 31, 2021 of $45.3 million
Management Commentary
"We are thrilled by the transformative potential of our proposed merger with Biosight and believe the opportunity to build a diversified clinical pipeline with both early and late-stage oncology assets will benefit both patients and our stockholders," said Kenneth A. Berlin, President, Chief Executive Officer and Interim Chief Financial Officer of Advaxis. "We expect that the coming months will provide data readouts from our expanded off-the-shelf neoantigen program in both NSCLC and prostate cancer which will build upon our strong foundation of data show consistent clinical benefit, the potential to enhance and/or restore responsiveness to checkpoint inhibitors and on-mechanism innate and adaptive immune system stimulation. These results, in combination with key data readouts from Biosight’s ongoing studies evaluating aspacytarabine in AML and MDS, will elucidate the promise of the combined clinical pipeline across both solid tumors and hematological malignancies and disorders. We look forward to continued progress in the clinic and expect to provide updated guidance regarding the proposed merger before year end."
Third Quarter Ended July 31, 2021 Financial Results
Research and development expenses for the third quarter of fiscal year 2021 were $1.70 million, compared with $3.46 million for the third quarter of fiscal year 2020. The decrease of $1.76 million was primarily attributable to the substantial reduction in costs associated with the winding down of clinical studies that have been discontinued.
General and administrative expenses for the three months ended July 31, 2021 were at $2.68 million, compared to $2.38 million in the same three-month period in fiscal 2020. The increase of $0.3 million primarily relates to increases in legal and consulting fees, and were partially offset by decreases in rent and utilities, personnel costs, and charges related to the abandonment of non-strategic intellectual property.
As of July 31, 2021, the Company had approximately $45.3 million in cash and cash equivalents.