On March 17, 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 first quarter ended January 31, 2022 and provides a business update (Press release, Advaxis, MAR 17, 2022, View Source [SID1234610243]).

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First Quarter Ended January 31, 2022 Financial Results and Recent Key Accomplishments:

Announced that the Company’s common stock would begin trading on the OTCQX Best Market ("OTCQX") on December 23, 2021, under the symbol ADXS
Announced updated clinical data from the Company’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA (pembrolizumab)
In Part B of the study, with ADXS-503 as an add on therapy for patients failing KEYTRUDA, a second patient showed partial response (PR), bringing the overall response rate to 15.4% (2/13) and the disease control rate to 46% (6/13). Clinical benefit was durable, with two patients sustaining PR for 23 and 6 months, respectively, while three maintained stable disease (SD) for 15, 6 and 4 months, respectively. Another patient with SD is still under evaluation
Combination therapy was well tolerated with no dose-limiting-toxicity (DLT) or added toxicity of the two drugs
Patients achieving clinical benefit include those with PD-L1 expression ≥50%, secondary resistance disease to KEYTRUDA and those with proliferation and/or activation of NK cells and CD8+ T cells within the initial weeks of therapy
In Part C, with ADXS-503 being dosed in combination with KEYTRUDA, preliminary data show disease control rate of 67% (2/3). The two patients sustained SD for 3 and 11 months, respectively
Announced offering pricing of $5 million of convertible redeemable Series D preferred stock through a private placement
Each share has a purchase price of $4.75, representing an original issue discount ("OID") of 5% of the stated value. The shares of Series D preferred stock are convertible into shares of the Company’s common stock, upon the occurrence of certain events, determined by dividing the $5.00 stated value of a share of preferred stock by the conversion price of $0.25, subject to adjustment
The Series D preferred stockholders may exercise the option to convert the shares at any time following the receipt of the stockholder approval for a reverse stock split
Upcoming milestones
The results of translational studies, including flow cytometry, ELISPOT, cytokine/chemokine levels, mutational analysis, MSI TMB and cfDNA and their clinical correlates, will be presented at an upcoming medical meeting

Management Commentary

"The impressive initial results from our on-going phase 1/2 study suggest that ADXS-503 has the capacity to restore responsiveness to check point inhibitors in patients who were no longer benefiting from these medications," said Kenneth A. Berlin, President, Chief Executive Officer and Interim Chief Financial Officer of Advaxis. "The 15.4% overall response rate is close to the 20% durable response rate that, in the absence of significant toxicity, could lead ADXS-503 to become a new therapeutic option for this underserved population. We look forward to completing the full enrollment of 18 patients in Part B of the study and to the continuing enrollment of first line patients in Part C. In addition, through our careful control of expenses we have extended our cash runway into the second fiscal quarter of 2024."

First Quarter Ended January 31, 2022 Financial Results

Research and development expenses for the first quarter of fiscal year 2022 were $1.7 million, compared with $2.6 million for the first quarter of fiscal year 2021. The reduction of $0.9 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 January 31, 2022 were approximately $2.5 million, compared to $3.0 million in the same three-month period in 2021. The decrease of $0.5 million primarily relates to decreases in rent and utilities, personnel costs and legal costs, which were partially offset by proxy fees and the abandonment of non-strategic intellectual property.

As of January 31, 2022, the Company had approximately $36.5 million in cash and cash equivalents.