GlobeNewswire Inc | Jun 14, 2021 04:05PM EDT

June 14, 2021

ADXS-503 Phase 1/2 trial data presented at ASCO demonstrate disease control rate of 44% with durable clinical benefit observed beyond one year in patients with disease progression on KEYTRUDA

Expansion of off-the-shelf ADXS-HOT program with planned Phase 1 study in early prostate cancer with biochemical recurrence

Cash runway anticipated into fiscal 3rd quarter of 2023

PRINCETON, N.J., June 14, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announces its financial results for the second quarter ended April 30, 2021 and provides a business update.

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), Mercks anti-PD-1 therapy, in non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) 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 efficacyCombination therapy was well tolerated with no dose-limiting toxicities (DLTs) or added toxicity of the two drugsThe 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 monthsBiomarker 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 therapyTranslational 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 upregulationContinuing 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) 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 Companys 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 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 Companys former location.

General and administrative expenses for the three months ended April 30, 2021 were at $3.35 million, compared to$2.65 millionin 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 Companys 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.

About Advaxis, Inc.Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietaryLm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. TheseLm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors.

To learn more about Advaxis, visitwww.advaxis.comand connect on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking StatementsThis press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to statements related to the expected clinical development of the Companys drug product candidates, statements about the Companys balance sheet position, including the sufficiency of the Companys cash and cash equivalents to fund its obligations into the future, and statements related to the goals, plans and expectations for the Companys ongoing clinical studies. These and other risks are discussed in the Companys filings with the SEC, including, without limitation, its Annual Report on Form 10-K, filed on January 22, 2021, and its periodic reports on Form 10-Q and Form 8-K. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

Contact:Tim McCarthy,LifeSci Advisors, LLC212.915.2564tim@lifesciadvisors.com

ADVAXIS, INC.CONDENSED BALANCE SHEETS(In thousands, except share and per share data)

April 30, October 2021 31, (Unaudited) 2020 ASSETS Current Assets: Cash and cash equivalents $ 48,110 $ 25,178 Deferred expenses 1,333 1,808 Accounts receivable 1,375 - Prepaid expenses and other current assets 1,295 865 Total current assets 52,113 27,851 Property and equipment (net of accumulated 333 2,393 depreciation)Intangible assets (net of accumulated 3,325 3,261 amortization)Operating right-of-use asset (net of accumulated - 4,839 amortization)Other assets - 182 Total assets $ 55,771 $ 38,526 LIABILITIES AND STOCKHOLDERS? EQUITY Current liabilities: Accounts payable $ 1,156 $ 410 Accrued expenses 2,133 1,737 Common stock warrant liability 4,931 17 Current portion of operating lease liability - 962 Deferred revenue - 165 Total current liabilities 8,220 3,291 Operating lease liability, net of current portion - 5,055 Total liabilities 8,220 8,346 Commitments and contingencies ? Note 9 Stockholders? equity: Preferred stock, $0.001 par value; 5,000,000shares authorized; Series B Preferred Stock; 0shares issued and outstanding at April 30, 2021 - - and October 31, 2020; Liquidation preference of $0at April 30, 2021 and October 31, 2020Common stock - $0.001 par value; 170,000,000shares authorized, 145,638,459 and 78,074,023 146 78 shares issued and outstanding at April 30, 2021and October 31, 2020, respectivelyAdditional paid-in capital 467,227 440,840 Accumulated deficit (419,822 ) (410,738 )Total stockholders? equity 47,551 30,180 Total liabilities and stockholders? equity $ 55,771 $ 38,526

ADVAXIS, INC.CONDENSED STATEMENTS OF OPERATIONS (Unaudited)(In thousands, except share and per share data)

Three Months Ended Six Months Ended April 30, April 30, 2021 2020 2021 2020 Revenue $ 1,375 $ 250 $ 2,990 $ 253 Operating expenses:Research anddevelopment 4,344 3,922 6,914 8,781 expensesGeneral andadministrative 3,352 2,649 6,360 5,679 expensesTotaloperating 7,696 6,571 13,274 14,460 expenses Loss from (6,321 ) (6,321 ) (10,284 ) (14,207 )operations Other income (expense):Interest 2 35 3 101 income, netNet changes infair value of 995 14 968 (23 )derivativeliabilitiesOther income 217 (1 ) 229 (1 )(expense)Net lossbefore income (5,107 ) (6,273 ) (9,084 ) (14,130 )taxes Income tax - 50 - 50 expense Net loss $ (5,107 ) $ (6,323 ) $ (9,084 ) $ (14,180 ) Net loss percommon share, $ (0.04 ) $ (0.10 ) $ (0.08 ) $ (0.25 )basic anddiluted Weightedaverage numberof common 123,145,051 60,572,632 111,895,403 56,107,657 shares, basicand diluted

ADVAXIS, INC.CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)(In thousands)

Six Months Ended April 30, 2021 2020 OPERATING ACTIVITIES Net loss $ (9,084 ) $ (14,180 )Adjustments to reconcile net loss to net cash used in operating activities:Stock compensation 451 452 Employee stock purchase plan expense - 1 Loss (gain) on change in value of warrants (968 ) 23 Loss on disposal of property and equipment 1,530 - Loss on write-down of intangible assets 69 - Abandonment of intangible assets - 603 Depreciation expense 316 457 Amortization expense of intangible assets 135 181 Amortization of right-of-use asset 327 365 Net gain on write off of right-of-use asset and (1,116 ) - lease liabilityChange in operating assets and liabilities: Accounts receivable (1,375 ) - Prepaid expenses, other current assets and 45 235 deferred expensesOther assets 182 1 Accounts payable and accrued expenses 1,142 (1,161 )Deferred revenue (165 ) - Operating lease liabilities (389 ) (397 )Net cash used in operating activities (8,900 ) (13,420 ) INVESTING ACTIVITIES Proceeds from disposal of property and equipment 214 - Cost of intangible assets (268 ) (358 )Net cash used in investing activities (54 ) (358 ) FINANCING ACTIVITIES Net proceeds of issuance of common stock and 28,115 9,628 warrantsWarrant exercises 3,771 - Proceeds from employee stock purchase plan - 4 Net cash provided by financing activities 31,886 9,632 Net increase in cash and cash equivalents 22,932 (4,146 )Cash and cash equivalents at beginning of period 25,178 32,363 Cash and cash equivalents at end of period $ 48,110 $ 28,217 SUPPLEMENTAL CASH FLOW INFORMATION Cash paid for taxes $ - $ 50 SUPPLEMENTAL DISCLOSURE OF NON-CASH AND FINANCING ACTIVITIESWarrant liability reclassified into equity - 2