Advaxis Reports Fiscal Year 2021 Financial Results and Provides a Business Update

February 14, 2022

MONMOUTH JUNCTION, N.J., Feb. 14, 2022 (GLOBE NEWSWIRE) -- Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announces its financial results for the fiscal year ended October 31, 2021 and provides a business update.

Fiscal Year 2021 and Recent Key Accomplishments: 

  • Presented updated clinical data from ongoing Phase 1/2 Trial of ADXS-503 in NSCLC
    • In Part B combination arm
      • a second partial response was observed
      • overall response rate was 15% and disease control rate was 46%
    • In Part C combination arm in newly diagnosed subjects
      • disease control rate of 67% was observed
  • Initiated Phase 1 trial of ADXS-504 for the treatment of early prostate cancer

Management Commentary
“Fiscal year 2021 was a busy year for Advaxis, with important clinical and biomarker data from the ongoing Phase 1/2 study of ADXS-503 in NSCLC which now consistently show the potential of ADXS-503 to synergistically enhance and/or restore sensitivity to checkpoint inhibitors,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “We are executing on the expansion of Part B to further evaluate the promising signals of sustained clinical benefit observed in Part B in NSCLC patients with immediate prior progression on KEYTRUDA®, as well as Part C, which will evaluate ADXS-503 in combination with KEYTRUDA® in the first line setting. Major milestones for the ADXS-503 trial in the second half of 2022 include updated clinical and immunogenicity data for all patients in Stage 1 in Part B and from up to 10 patients in Part C. Also, initial clinical and immunogenicity data from the ADXS-504 trial in early prostate cancer are expected to be reported in the second half of this year.”

Mr. Berlin continued, “We remain confident that our clinical strategy will explore the full potential of ADXS-503 to improve responses to checkpoint inhibitors across diverse clinical settings and patient populations. We are highly enthusiastic about the on-mechanism innate and adaptive immune stimulation seen in our broadly accessible, off-the-shelf neoantigen immunotherapy. In addition to these encouraging data, our strengthened balance sheet ensures our continued momentum with the ADXS-HOT program as we advance our Lm-technology to expand the reach of checkpoint inhibitors.”

Balance Sheet Highlights
As of October 31, 2021, Advaxis had cash and cash equivalents of $41.6 million. The Company used $15.4 million in cash to fund operations during fiscal year 2021, mainly attributed to funding research and development and general and administrative activities. Throughout fiscal year 2021, the Company continued to prioritize its main ADXS-503 product candidate while winding down its legacy studies and reducing its annual operating expenses by approximately $4.7 million, or nearly 18%.

Fiscal Year 2021 Financial Information
Research and development expenses for fiscal year 2021 were $10.6 million, compared with $15.6 million for fiscal year 2020. The $5.0 million decrease was primarily attributable to decreases in clinical, laboratory and personnel costs as a result of the winding down of several legacy studies.

General and administrative expenses for fiscal year 2021 were $11.5 million, compared to $11.1 million for fiscal year 2020.

The net loss for the fiscal year ended October 31, 2021 was $17.9 million or $0.14 per share based on approximately 129 million weighted average shares outstanding. This compares with a net loss for fiscal year 2020 of $26.5 million or $0.43 per share based on approximately 61 million weighted average shares outstanding.

About Advaxis, Inc.

Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-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. These Lm-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, visit

Forward-Looking Statements

This 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 risks associated with being listed on the OTCQX; the outcome of any legal proceedings that may be instituted against the Company; the Company’s history of net operating losses and uncertainty regarding its ability to achieve profitability; expected clinical development of the Company’s drug product candidates, statements about the Company’s balance sheet position, including the sufficiency of the Company’s cash and cash equivalents to fund its obligations into the future, and statements related to the goals, plans and expectations for the Company’s ongoing clinical studies. These and other risks are discussed in the Company’s 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.

Tim McCarthy, LifeSci Advisors, LLC

(In thousands, except share and per share data)

    October 31,  
    2021     2020  
Current assets:                
Cash and cash equivalents   $ 41,614     $ 25,178  
Deferred expenses     -       1,808  
Prepaid expenses and other current assets     1,643       865  
Total current assets     43,257       27,851  
Property and equipment (net of accumulated depreciation)     118       2,393  
Intangible assets (net of accumulated amortization)     3,354       3,261  
Operating right-of-use asset (net of accumulated amortization)     40       4,839  
Other assets     11       182  
Total assets   $ 46,780     $ 38,526  
Current liabilities:                
Accounts payable   $ 87     $ 410  
Accrued expenses     2,836       1,737  
Current portion of operating lease liability     28       962  
Deferred revenue     -       165  
Common stock warrant liability     4,929       17  
Total current liabilities     7,880       3,291  
Operating lease liability, net of current portion     12       5,055  
Total liabilities     7,892       8,346  
Contingencies – Note 10                
Stockholders’ equity:                
Preferred stock, $0.001 par value; 5,000,000 shares authorized; Series B Preferred Stock; 0 shares issued and outstanding at October 31, 2021 and 2020. Liquidation preference of $0 at October 31, 2021 and 2020.     -       -  
Common stock - $0.001 par value; 170,000,000 shares authorized, 145,638,459 and 78,074,023 shares issued and outstanding at October 31, 2021 and 2020.     146       78  
Additional paid-in capital     467,342       440,840  
Accumulated deficit     (428,600 )     (410,738 )
Total stockholders’ equity     38,888       30,180  
Total liabilities and stockholders’ equity   $ 46,780     $ 38,526  

(In thousands, except share and per share data)

    Year Ended October 31,  
    2021     2020  
Revenue   $ 3,240     $ 253  
Operating expenses:                
Research and development expenses     10,562       15,612  
General and administrative expenses     11,464       11,090  
Total operating expenses     22,026       26,702  
Loss from operations     (18,786 )     (26,449 )
Other income (expense):                
Interest income     5       110  
Net changes in fair value of derivative liabilities     970       -  
Loss on shares issued in settlement of warrants     -       (77 )
Other expense     (1 )     (3 )
Net loss before income tax benefit     (17,812 )     (26,419 )
Income tax expense     50       50  
Net loss   $ (17,862 )   $ (26,469 )
Net loss per common share, basic and diluted   $ (0.14 )   $ (0.43 )
Weighted average number of common shares outstanding, basic and diluted     129,090,709       61,003,839  


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Source: Advaxis, Inc.