ADXS Advaxis Inc.

0.55
+0.02  (+5%)
Previous Close 0.53
Open 0.56
52 Week Low 0.2051
52 Week High 1.95
Market Cap $34,167,564
Shares 61,607,580
Float 61,542,143
Enterprise Value $10,874,017
Volume 591,704
Av. Daily Volume 1,380,653
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Drug Pipeline

Drug Stage Notes
ADXS-PSA and Keytruda - KEYNOTE-046
Castrate-resistant prostate cancer
Phase 1/2
Phase 1/2
Phase 1 presentation at ASCO Genitourinary Cancers Symposium February 13, 2020 noted median overall survival (95% CI) of 33.7 months.
ADXS-HOT 503
Non-small cell lung cancer (NSCLC)
Phase 1/2
Phase 1/2
Phase 1 data noted 50% (3 of 6) of evaluable patients from monotherapy arm and 1/1 patients on combo arm (Keytruda) showed stable disease - February 20, 2020.
Axalimogene filolisbac + durvalumab
Recurrent or refractory HPV-associated cervical cancer and head & neck cancer
Phase 1/2
Phase 1/2
Enrollment to be terminated - noted November 2, 2018.
ADXS-NEO
Non-small cell lung cancer (NSCLC)
Phase 1
Phase 1
Phase 1 safety and immunogenicity data presented at AACR March 2019
Axalimogene filolisbac - AIM2CERV Trial
High-risk, locally advanced cervical cancer
Phase 3
Phase 3
Phase 3 trial closed - noted June 27, 2019.
Axalimogene filolisbac
Anal cancer (FAWCETT)
Phase 2
Phase 2
Noted in 10-K December 21, 2017 that it will not initiate the Stage 2 portion of the trial in order to focus its resources on other clinical priorities.
ADXS-HER2
HER2-driven malignancies - cancer
Phase 1b
Phase 1b
Decided not to proceed to the expansion phase of the trial - noted in 10K December 21, 2017.

Latest News

  1. PRINCETON, N.J., June 23, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced that Kenneth A. Berlin, President and Chief Executive Officer of Advaxis, will be featured in a webinar, "Grand Rounds: A Webinar in Biotech and Specialty Pharma," hosted by James Molloy, Managing Director of Equity Research, Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners, on Monday, June 29, 2020.

    Presentation Information:
    Date: Monday, June 29, 2020
    Time: 11:00amET / 8:00amPT
    Webcast: https://us02web.zoom.us/webinar/register/WN_ghcqA0vHSX2Zxa3bR533Bw


    About Advaxis, Inc.

    Advaxis, Inc. is a clinical-stage biotechnology…

    PRINCETON, N.J., June 23, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced that Kenneth A. Berlin, President and Chief Executive Officer of Advaxis, will be featured in a webinar, "Grand Rounds: A Webinar in Biotech and Specialty Pharma," hosted by James Molloy, Managing Director of Equity Research, Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners, on Monday, June 29, 2020.

    Presentation Information:
    Date: Monday, June 29, 2020
    Time: 11:00amET / 8:00amPT
    Webcast: https://us02web.zoom.us/webinar/register/WN_ghcqA0vHSX2Zxa3bR533Bw



    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 www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.

    Investor Contact

    Tim McCarthy

    LifeSci Advisors, LLC



    (212) 915-2564

    Primary Logo

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  2. Expanding Phase 1/2 Study of ADXS-503 in NSCLC based on sustained and durable clinical responses in first two patients from Part B combination arm with KEYTRUDA®

    Increasing patient enrollment in Part B and initiating Part C to move into first-line regimen with KEYTRUDA® in patients ineligible for standard of care platinum-based chemotherapy

    Conference call scheduled for 11am ET today

    PRINCETON, N.J., June 11, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced an update on its clinical pipeline and financial results for the second quarter ended April 30, 2020.

    Key recent corporate and clinical pipeline updates…

    Expanding Phase 1/2 Study of ADXS-503 in NSCLC based on sustained and durable clinical responses in first two patients from Part B combination arm with KEYTRUDA®

    Increasing patient enrollment in Part B and initiating Part C to move into first-line regimen with KEYTRUDA® in patients ineligible for standard of care platinum-based chemotherapy

    Conference call scheduled for 11am ET today

    PRINCETON, N.J., June 11, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced an update on its clinical pipeline and financial results for the second quarter ended April 30, 2020.

    Key recent corporate and clinical pipeline updates:

    • Presented updated clinical and preliminary biomarker data from the ongoing Phase 1/2 trial of ADXS-503 in non-small cell lung cancer (NSCLC) demonstrating clinical benefit in two patients with immediate prior progression on KEYTRUDA® including one durable response out to 25 weeks and another sustained response out to out least 16 weeks with both patients remaining on treatment in Part B, the combination arm with KEYTRUDA®  
      • One sustained partial response with 60% reduction in site lesions at 16 weeks and one durable response of stable disease with 25% reduction in target lesion at 25 weeks confirmed by radiographic scans
      • Clinical benefit achieved after immediate prior progression on KEYTRUDA® with previous best responses of stable disease suggest ADXS-503 may re-sensitize or enhance response to KEYTRUDA®
    • Part A monotherapy has been completed with three of six evaluable patients achieving responses of stable disease
    • As monotherapy, as well as in combination with KEYTRUDA®, ADXS-503 appeared safe and well tolerated with no dose-limiting toxicities
    • Preliminary biomarker data from seven patients in Part A monotherapy demonstrated activation of cytotoxic and memory CD8+ and CD4+ T cells in 100% of patients and antigen spreading in five of seven evaluable patients, including the first patient in combination therapy
    • Presented updated survival data from the Phase 1/2 trial with ADXS-PSA in combination with KEYTRUDA® at the ASCO Genitourinary Cancers Symposium. Data highlights include reported median overall survival (95% CI) of 16.4 months (4.0-NR) (n=11) for advanced prostate cancer patients with prior docetaxel therapy and visceral metastases treated with ADXS-PSA in combination with KEYTRUDA® compared to an estimated 11 months with current standard of care. In addition, median overall survival (95% CI) was 33.7 months (15.4-33.7) in all patients treated with ADXS-PSA in combination with KEYTRUDA® (n=37)
    • Announced a research agreement with Personalis to deploy ImmunoID NeXT Platform in the ADXS-503 clinical program. Personalis will conduct comprehensive tumor genomic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance

    Management Commentary

    "We have continued our momentum throughout the second quarter with updated clinical data which support the prioritization of our off-the-shelf neoantigen HOT program," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "These updated data from our ongoing Phase 1/2 study of ADXS-503 in NSCLC increase our confidence that ADXS-503 may synergistically enhance and/or restore sensitivity to checkpoint inhibitors and we are particularly encouraged by the sustained clinical benefit observed, now out to 16 and 25 weeks, in two patients who had immediate prior progression on KEYTRUDA®. Our results are further supported by preliminary biomarker data which provide insight into the on-mechanism immune stimulation which we believe are driving these responses."

    Mr. Berlin continued, "Based on these results, we are expanding Part B, dose level 1, to enroll up to an additional 15 patients who have progressed on KEYTRUDA® to further characterize the clinical activity of ADXS-503 in combination with KEYTRUDA® as previously observed in the first two evaluable patients in this part of our study.  In addition, we have opened enrollment in Part C to evaluate ADXS-503 in combination with KEYTRUDA® as a first line treatment for patients with metastatic NSCLC that either have a high PD-L1 expression score and can receive KEYTRUDA® alone or for patients who are ineligible to receive the standard of care regimen of KEYTRUDA® in combination with platinum based-chemotherapy." He added, "The safety, tolerability and clinical activity observed so far supports the initiation of Part C for advanced patients in a first-line setting as well as the expansion of Part B in later treatment settings. Based on the clinical and immune correlative results to date, we are hopeful for enhanced responses to KEYTRUDA® in patients in both of these settings who have limited treatment options and poor prognoses.  We look forward to continued execution and the expansion of our HOT program to new indications including our planned Phase 1 study of ADXS-504 in prostate cancer patients with biochemical recurrence which we expect to enter the clinic by the end of this year." 

    Second Quarter Ended April 30, 2020 Financial Results

    Research and development expenses for the second quarter of fiscal year 2020 were $3.9 million, compared with $6.0 million for the second quarter of fiscal year 2019. The decrease is largely attributable to the winding down of our Phase 3 AIM2CERV and Phase 1 ADXS-NEO studies as announced in June 2019 and October 2019, respectively.

    General and administrative expenses for the three months ended April 30, 2020 were approximately $2.6 million compared to $3.1 million in the same three-month period in 2019. The decrease in expenses is mainly attributable to lower legal fees, and reduced employee and business development costs.

    As of April 30, 2020, the Company had approximately $28.2 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 until at least August 2021.

    The company will host a conference call today at 11:00am ET to provide a business update. The call-in information is below and accessible on the Company's investor relations section of its website:

    Webcast: http://public.viavid.com/index.php?id=140132

    Domestic: 877-407-0789

    International: 201-689-8562

    Conference ID: 13704683

    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 www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.

    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 expected clinical development of the Company's drug product candidates. 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 December 20, 2019 and Form 10-K/A on February 28, 2020, 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.

     

    Advaxis, Inc.
    Selected Balance Sheet Data
    (In thousands)
     
     April 30,   
     2020  October 31,
     (Unaudited)  2019
    Cash and cash equivalents$28,217  $32,363 
    Total assets$45,210  $45,257 
    Total stockholders' equity$35,437  $39,531 

    STATEMENTS OF OPERATIONS

    (unaudited, in thousands, except share and per share data)

      

      Three Months Ended

    April 30,
      Six Months Ended

    April 30,
     
      2020  2019  2020  2019 
                 
    Revenue $250  $1,188  $253  $20,877  
                      
    Operating expenses *                 
    Research and development expenses  3,922   5,969   8,781   12,675  
    General and administrative expenses  2,649   3,092   5,679   5,759  
    Total operating expenses  6,571   9,061   14,460   18,434  
                      
     (Loss) income from operations  (6,321)  (7,873)  (14,207)  2,443  
                      
    Other income (expense)  48   (1,510)  97   1,041  
    Net (loss) income before benefit for income taxes  (6,273)  (9,383)  (14,130)  3,484  
                      
    Income tax expense  50   -   50   50  
                      
    Net (loss) income $(6,323) $(9,383) $(14,180) $3,434  
                    



     
      
    Net (loss) income per common share, diluted                 
    Basic   (0.10) $(1.59) $(0.25) $0.65  
    Diluted $(0.10) $(1.59) $(0.25) $0.20  
                      
    Weighted average number of common shares outstanding                  
    Basic  60,572,632   5,900,449   56,107,657   5,259,677  
    Diluted  60,572,632   5,900,449   56,107,657   5,282,772  
                      
    * Includes stock-based compensation as follows:                 
    Research and development $62  $258  $153  $581  
    General and administrative  148   221   299   520  
      $210  $479  $452  $1,101  

    Contact:

    Tim McCarthy, LifeSci Advisors, LLC

    212.915.2564

     

    Primary Logo

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  3. PRINCETON, N.J., June 01, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, announced today that it will release financial results for the second quarter ended April 30, 2020 before the market opens on Thursday, June 11, 2020. The company will host a conference call at 11:00am EDT on the same day to provide a business update.

    Thursday, June 11, 11:00 am EDT
    Webcast: http://public.viavid.com/index.php?id=140132
    Domestic: 877-407-0789
    International: 201-689-8562
    Conference ID: 13704683

    About Advaxis, Inc.
    Advaxis, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of proprietary…

    PRINCETON, N.J., June 01, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, announced today that it will release financial results for the second quarter ended April 30, 2020 before the market opens on Thursday, June 11, 2020. The company will host a conference call at 11:00am EDT on the same day to provide a business update.

    Thursday, June 11, 11:00 am EDT
    Webcast: http://public.viavid.com/index.php?id=140132
    Domestic: 877-407-0789
    International: 201-689-8562
    Conference ID: 13704683

    About Advaxis, Inc.
    Advaxis, Inc. is a clinical-stage biotechnology company focused on the discovery, 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 www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.

    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 expected clinical development of the Company's drug product candidates. 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 December 20, 2019, 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.

    Contact:
    Tim McCarthy, LifeSci Advisors, LLC
    212.915.2564

    Primary Logo

    View Full Article Hide Full Article
  4. Sustained clinical benefit seen in patients treated with ADXS-503 in combination with KEYTRUDA® after 16 weeks, including a partial response and stable disease in patients who had most recently progressed on KEYTRUDA®

    Positive preliminary immunogenicity data with CD8+ T cells generated in all of the first seven patients evaluated for ADXS-503 antigens

    PRINCETON, N.J., May 14, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced updated clinical and biomarker results from the monotherapy and combination arms of the Company's ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer…

    Sustained clinical benefit seen in patients treated with ADXS-503 in combination with KEYTRUDA® after 16 weeks, including a partial response and stable disease in patients who had most recently progressed on KEYTRUDA®

    Positive preliminary immunogenicity data with CD8+ T cells generated in all of the first seven patients evaluated for ADXS-503 antigens

    PRINCETON, N.J., May 14, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced updated clinical and biomarker results from the monotherapy and combination arms of the Company's ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer (NSCLC). The trial is evaluating ADXS-503, alone and in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy.  ADXS-503 is part of the Company's ADXS-HOT cancer-type specific immunotherapy program which leverages Advaxis' proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens.

    Key data updates:

    • Sustained clinical benefit in the combination arm, Part B, in the first two evaluable patients who had previously progressed on KEYTRUDA® as last therapy whose best response while on KEYTRUDA® was stable disease.
      • One observed partial response and one response of stable disease with 25% reduction in a target lesion, as confirmed in the radiographic scans at 16 weeks of combination therapy  
      • Responses achieved after immediate prior progression on KEYTRUDA® with previous best responses of stable disease suggests ADXS-503 may re-sensitize or enhance response to KEYTRUDA®
    • Preliminary biomarker data from seven patients in monotherapy demonstrates:
      • Activation of cytotoxic and memory CD8+ and CD4+ T cells
      • CD8+ T cells generated in all seven patients evaluated
      • Antigen spreading observed in five of seven patients for epitopes not incorporated in ADXS-503
    • Part A monotherapy has been completed (n=7) with three out of six (50%) evaluable patients showing stable disease.
    • As a monotherapy, and in combination with KEYTRUDA®, ADXS-503 appeared safe and well tolerated with no dose limiting toxicities at the dose-levels evaluated.                         

    "We are thrilled to see sustained clinical benefit with ADXS-503 in combination with KEYTRUDA® in these first two evaluable patients who had recently progressed on KEYTRUDA®," said Ken Berlin, Chief Executive Officer of Advaxis. "Importantly these responses were achieved in patients with prior best responses that were limited to stable disease during their two years on this checkpoint inhibitor. Taken together, these results leave us increasingly confident that ADXS-503 has the potential to restore or enhance sensitivity to checkpoint inhibitors. In addition, we believe our recent biomarker data, which shows the robust and specific activation of an immune response to ADXS-503 antigens, provides important understanding and validation of the mechanism of action of ADXS-503."

    Dr. Andres Gutierrez, Chief Medical Officer at Advaxis, said, "With these promising clinical, safety and immunogenicity data, we have decided to expand Part B of the study, which will continue evaluating patients that have progressed on KEYTRUDA® as their last prior therapy. In addition, we will start Part C of the trial to evaluate ADXS-503 with KEYTRUDA® combination therapy as a first line treatment for NSCLC patients that cannot tolerate the standard of care regimen with KEYTRUDA® in combination with chemotherapy. With the recent dosing of the third patient in Part B, Dose Level 1 which completes this cohort, we anticipate beginning enrollment in the Part B expansion and Part C in early June and look forward to continued progress as we evaluate the ability of ADXS-503 to generate anti-tumor immune responses in advanced NSCLC patients with significant need for new treatment options."

    The Phase 1/2 clinical trial of ADXS-503 is seeking to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a KEYTRUDA® in approximately 50 patients with NSCLC, in at least five sites across the U.S. The two dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed and Part B with ADXS-503 (1 X108 CFU) in combination with KEYTRUDA® is currently closed to enrollment. With preliminary encouraging safety and efficacy results, the Company is planning to expand Part B to additional patients at dose level 1 (1 X108 CFU + KEYTRUDA®) with the potential to proceed to dose level 2 (5 X108 CFU + KEYTRUDA®) at a later date. In addition, the Company intends to expand the study to Part C, which will evaluate ADXS-503 in combination with KEYTRUDA® (1 X108 CFU + KEYTRUDA®) as a first line treatment for patients that are medically unfit to receive the standard of care regimen with KEYTRUDA® in combination with chemotherapy.

    About ADXS-HOT
    ADXS-HOT is a program that leverages the Company's proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.

    About Advaxis, Inc.
    Advaxis, Inc. is a clinical-stage biotechnology company focused on the discovery, 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 www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.

    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 expected clinical development of the Company's drug product candidates. 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 December 20, 2019, 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.https://www.businesswire.com/images/spacer.gif

    Contact:
    Tim McCarthy, LifeSci Advisors, LLC
    212.915.2564

    Primary Logo

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  5. PRINCETON, N.J., March 13, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced an update on its clinical pipeline and financial results for the first quarter ended January 31, 2020.

    Key recent corporate and clinical pipeline updates:

    • Presented updated clinical data from the ongoing Phase 1/2 ADXS-503 trial at the I/O 360° Conference. Data presented showed that the first two patients treated in the combination arm, who previously progressed on KEYTRUDA®, achieved a partial response with substantial tumor shrinkage of nearly 60% and the other patient achieving stable disease with a 25% reduction in a target lesion…

    PRINCETON, N.J., March 13, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced an update on its clinical pipeline and financial results for the first quarter ended January 31, 2020.

    Key recent corporate and clinical pipeline updates:

    • Presented updated clinical data from the ongoing Phase 1/2 ADXS-503 trial at the I/O 360° Conference. Data presented showed that the first two patients treated in the combination arm, who previously progressed on KEYTRUDA®, achieved a partial response with substantial tumor shrinkage of nearly 60% and the other patient achieving stable disease with a 25% reduction in a target lesion.
    • Presented updated survival data from the Phase 1/2 ADXS-PSA trial at the ASCO Genitourinary Cancers Symposium. Data highlights include reported median overall survival (95% CI) of 16.4 months (4.0-NR) (n=11) for advanced prostate cancer patients with visceral metastases treated with ADXS-PSA in combination with KEYTRUDA® compared to an estimated 11 months with current standard of care. In addition, median overall survival (95% CI) was 33.7 months (15.4-33.7) in all patients treated with ADXS-PSA in combination with KEYTRUDA® (n=37).
    • Data presented in 2020 suggest that both ADXS-503 and ADXS-PSA may have the potential to enhance or restore sensitivity to checkpoint inhibitors such as KEYTRUDA®.
    • Announced FDA allowance of its Investigational New Drug Application (IND) for ADXS-504 for the treatment of prostate cancer. ADXS-504 is the Company's second drug product candidate from its HOT off-the-shelf neoantigen clinical program targeting hotspot mutations and other tumor-associated antigens.
    • Closing of a $10.5 million equity financing with two investors.
    • Announced a research agreement with Personalis to deploy ImmunoID NeXT Platform in the ADXS-503 clinical program. Personalis will conduct comprehensive tumor immunogenic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance.

    Management Commentary
    "We have started our fiscal year with encouraging positive data presented in our ADXS-PSA and ADXS-503 clinical programs," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Importantly, data from both studies suggest that Lm immunotherapies may have the ability to synergistically enhance or restore sensitivity to checkpoint inhibitors which could be a meaningful breakthrough in improving outcomes for advanced and refractory patients. We continue to execute on our HOT off-the-shelf program in NSCLC with enrollment continuing in the combination arm of the study, Part B, and a planned initiation of Part C which will move combination therapy to a first-line setting, later this year. We are also planning to move an additional HOT construct, ADXS-504, for prostate cancer, into the clinic later this year for which the IND was allowed earlier this year."

    Mr. Berlin continued, "We are currently evaluating next steps for our ADXS-PSA program based on the promising increases in median overall survival observed in combination with KEYTRUDA®. With an anticipated cash runway into mid-2021, we are positioned to explore the early signals of activity in our ongoing trials while advancing additional programs that leverage these important findings."

    First Quarter Ended January 31, 2020 Financial Results
    During the quarter ended January 31, 2019, the Company recognized $19.4 million in revenue associated with the revenue recognition requirements surrounding the termination of the collaboration agreement with Amgen in 2019; no similar situation existed during the fiscal quarter ended January 31, 2020.

    Research and development expenses for the first quarter of fiscal year 2020 were $4.9 million, compared with $6.7 million for the first quarter of fiscal year 2019. The decrease is largely attributable to the winding down of our Phase 3 AIM2CERV and Phase 1 ADXS-NEO studies as announced in June 2019 and October 2019, respectively.

    General and administrative expenses for the three months ended January 31, 2020 were approximately $3.0 million compared to $2.7 million in the same three-month period in 2019 as a result of higher business development and legal fees.

    As of January 31, 2020, the Company had approximately $34.2 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 until at least mid-2021.

    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 www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.

    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 expected clinical development of the Company's drug product candidates. 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 December 20, 2019 and Form 10-K/A on February 28, 2020, 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.

    Advaxis, Inc.
    Selected Balance Sheet Data
    (In thousands)
     
        January 31,   October 31,
        2020   2019
    Cash and cash equivalents   $ 34,156     $ 32,363
    Total assets   $ 51,348     $ 45,257
    Total stockholders' equity   $ 41,548     $ 39,531
                   


     
    STATEMENTS OF OPERATIONS
    (in thousands, except share and per share data)
         
        Three Months Ended
    January 31,
        2020     2019
               
    Revenue   $ 3     $ 19,689
                   
    Operating expenses*              
    Research and development expenses     4,859       6,707
    General and administrative expenses     3,030       2,666
    Total operating expenses     7,889       9,373
                   
    (Loss) income from operations     (7,886 )     10,316
                   
    Net changes in fair value of derivative liabilities     (37 )     2,409
    Other income and taxes     66       92
    Net (loss) income   $ (7,857 )   $ 12,817
                   
    Net (loss) income per common share, basic and diluted   $ (0.15 )   $ 2.76
                   
    Weighted average number of common shares outstanding, basic     51,412,408       4,642,718
    Weighted average number of common shares outstanding, diluted     51,412,408       4,642,817
                   
    * Includes stock-based compensation as follows:              
    Research and development   $ 91     $ 323
    General and administrative     151       299
        $ 242     $ 622


























    Contact:
    Tim McCarthy, LifeSci Advisors, LLC
    212.915.2564

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