ADXS Advaxis Inc.

0.44
+0.01  (+3%)
Previous Close 0.43
Open 0.43
52 Week Low 0.2051
52 Week High 1.48
Market Cap $29,471,225
Shares 66,227,473
Float 66,162,036
Enterprise Value $11,855,225
Volume 426,497
Av. Daily Volume 1,000,121
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Upcoming Catalysts

Drug Stage Catalyst Date
ADXS-HOT 503
Non-small cell lung cancer (NSCLC)
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
ADXS-NEO
Non-small cell lung cancer (NSCLC)
Phase 1
Phase 1
Phase 1 safety and immunogenicity data presented at AACR March 2019
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.
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.
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. Strategic expansion of ADXS-503 HOT program in NSCLC to explore potential to enhance and or restore sensitivity to checkpoint inhibitors

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

    Enrolling in Part C for first-line regimen with KEYTRUDA® in NSCLC patients with PD-L1 expression ≥ 1% and patients who are unfit for standard of care combination therapy with KEYTRUDA® and platinum-based chemotherapy

    PRINCETON, N.J., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products…

    Strategic expansion of ADXS-503 HOT program in NSCLC to explore potential to enhance and or restore sensitivity to checkpoint inhibitors

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

    Enrolling in Part C for first-line regimen with KEYTRUDA® in NSCLC patients with PD-L1 expression ≥ 1% and patients who are unfit for standard of care combination therapy with KEYTRUDA® and platinum-based chemotherapy

    PRINCETON, N.J., Sept. 10, 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 third quarter ended July 31, 2020.

    Key recent corporate and clinical pipeline updates:

    • Presented updated clinical data from the ongoing Phase 1/2 trial of ADXS-503 in non-small cell lung cancer (NSCLC) demonstrating durable clinical benefit in two out of 3 evaluable patients with immediate prior progression on KEYTRUDA® including one durable response now out to 34 weeks with 25% reduction in target lesion and another sustained response now out to 33 weeks with a 60% reduction in site lesions. Both patients remain on treatment in Part B, the combination arm with KEYTRUDA®  
      • 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®
    • Initiated ADXS-503 Part B combination arm efficacy expansion which will enroll up to 15 patients to evaluate the potential of ADXS-503 in combination with KEYTRUDA® to restore and/or enhance responsiveness to checkpoint inhibitors in PD-1/L-1 refractory NSCLC patients
    • Initiated ADXS-503 Part C combination arm to evaluate ADXS-503 in combination with KEYTRUDA® as a first line treatment in patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy
    • ADXS-503 monotherapy and in combination with KEYTRUDA® appeared safe and well tolerated with no dose limiting toxicities or added toxicity in the combination setting
    • Announced common stock purchase agreement for up to $20 million with Lincoln Park Capital

    Management Commentary

    "We are highly encouraged by the clinical and on-mechanism biomarker data from our ongoing Phase 1/2 study of ADXS-503 in NSCLC and have continued to execute on our expansion of the evaluation of 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. "This quarter, we have begun enrollment in the expansion of Part B to further evaluate the promising signals of sustained clinical benefit observed in the first dose cohort of Part B in NSCLC patients with immediate prior progression on KEYTRUDA®. This could yet be another strategy to rechallenge the tumor with a checkpoint inhibitor without having to stop the drug at progression. In addition, we have started enrollment in Part C which will evaluate ADXS-503 in combination with KEYTRUDA®, moving our HOT program to a first line treatment for patients with metastatic NSCLC that would receive KEYTRUDA® alone as per label indication (i.e., PD-L1 expression ≥ 1%) and patients who are unfit to receive the standard of care regimen of KEYTRUDA® in combination with platinum based-chemotherapy. We believe these two clinical evaluations in Part B and Part C of this study will elucidate the potential of ADXS-503 to improve responses to checkpoint inhibitors in diverse clinical settings and for patients who have limited treatment options. We anticipate having additional data on this program by the end of the year."  

    Mr. Berlin continued, "We are particularly encouraged by the safety and tolerability profile of ADXS-503 as a monotherapy and in combination KEYTRUDA®, and with no dose limiting toxicities observed, we believe this can be an important addition to standard of care for those patients whose illness makes them ineligible for other forms of chemotherapy. Our recently announced common stock purchase agreement allows us to continue the prioritization of our HOT program with the ongoing expansions in NSCLC as well as the initiation of a Phase 1 study of ADXS-504 in prostate cancer patients with biochemical recurrence before year end."

    Third Quarter Ended July 31, 2020 Financial Results

    Research and development expenses for the third quarter of fiscal year 2020 were $3.5 million, compared with $7.1 million for the third quarter of fiscal year 2019. The decrease is largely attributable to the winding down of the 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 July 31, 2020 were approximately $2.4 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 business development costs.

    As of July 31, 2020, the Company had approximately $23.8 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 July 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)
     
     July 31,  
     2020  October 31,
     (Unaudited)  2019
    Cash and cash equivalents$23,846  $32,363 
    Total assets$40,019  $45,257 
    Total stockholders' equity$31,466  $39,531 



    STATEMENTS OF OPERATIONS

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

      Three Months Ended

    July 31,
      Nine months ended

    July 31,
     
      2020  2019  2020  2019 
                 
    Revenue $-  $6  $253  $20,883 
                     
    Operating expenses:                
    Research and development expenses  3,458   7,060   12,239   19,735 
    General and administrative expenses  2,384   3,076   8,063   8,834 
    Total operating expenses  5,842   10,136   20,302   28,569 
                     
    Loss from operations  (5,842)  (10,130)  (20,049)  (7,686)
                     
    Other income  13   272   90   1,312 
                     
    Net loss before benefit for income taxes  (5,829)  (9,858)  (19,959)  (6,374)
                     
    Income tax expense  -   -   50   50 
                     
    Net loss $(5,829) $(9,858) $(20,009) $(6,424)
                     
    Net loss per common share, basic and diluted $(0.09) $(1.00) $(0.35) $(0.94)
                     
    Weighted average number of common shares outstanding, basic and diluted  61,634,031   9,870,461   57,963,228   6,813,494 
                     
    * Includes stock-based compensation as follows:                
    Research and development $79  $241  $233  $822 
    General and administrative  176   223   475   743 
      $255  $464  $708  $1,565 

    Contact:

    Tim McCarthy, LifeSci Advisors, LLC

    212.915.2564

     

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  2. PRINCETON, N.J., Sept. 04, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced that Molly Henderson, Executive Vice President and Chief Financial Officer, has resigned effective September 25, 2020 to pursue another business opportunity. Kenneth A. Berlin, Advaxis' President and Chief Executive Officer, will serve as interim Chief Financial Officer until a new Chief Financial Officer is appointed.

    "We are grateful for Molly's numerous contributions to Advaxis over the past two years," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Her exceptional leadership and financial stewardship…

    PRINCETON, N.J., Sept. 04, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced that Molly Henderson, Executive Vice President and Chief Financial Officer, has resigned effective September 25, 2020 to pursue another business opportunity. Kenneth A. Berlin, Advaxis' President and Chief Executive Officer, will serve as interim Chief Financial Officer until a new Chief Financial Officer is appointed.

    "We are grateful for Molly's numerous contributions to Advaxis over the past two years," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Her exceptional leadership and financial stewardship played an important role in allowing the company to focus its resources on, and advance the development of, our HOT programs. We wish her success in her new endeavor."

    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.

    Contact:

    Tim McCarthy, LifeSci Advisors, LLC

    212.915.2564

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  3. PRINCETON, N.J., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced that it has entered into a common stock purchase agreement for up to $20 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor. Upon execution of the purchase agreement, Lincoln Park made an initial purchase of $2 million of common stock at $0.57 per share.

    Under the terms of the purchase agreement, Advaxis will have the right at its sole discretion, but not the obligation, to sell to LPC up to $20 million worth of shares over the 36-month term of the agreement, subject to certain conditions. There…

    PRINCETON, N.J., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced that it has entered into a common stock purchase agreement for up to $20 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor. Upon execution of the purchase agreement, Lincoln Park made an initial purchase of $2 million of common stock at $0.57 per share.

    Under the terms of the purchase agreement, Advaxis will have the right at its sole discretion, but not the obligation, to sell to LPC up to $20 million worth of shares over the 36-month term of the agreement, subject to certain conditions. There are no upper limits to the price per share LPC may pay to purchase the shares, and the purchase price of the shares will be based on the prevailing market prices at the time of each sale to LPC. Advaxis controls the timing and amount of any future sales of its stock to LPC.

    There are no warrants, derivatives, financial or business covenants associated with the agreement, and LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Advaxis' common stock. Advaxis may terminate the purchase agreement at any time, at its discretion, without any cost or penalty.  In consideration for LPC entering into the purchase agreement, Advaxis issued shares of its common stock to LPC as a fee for LPC's obligation to purchase shares at the Company's discretion.

      

    Advaxis intends to use any net proceeds from the sale of its common stock to LPC to advance its ADXS-HOT program and for general corporate purposes.

    Additional information regarding the purchase agreement with LPC is available in the Current Report on Form 8-K that Advaxis will file with the Securities and Exchange Commission.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy any shares of common stock, nor shall there be any sale of shares of common stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    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.

    About Lincoln Park Capital Fund, LLC

    LPC is a long-only institutional investor headquartered in Chicago, Illinois. LPC's experienced professionals manage a portfolio of investments in public and private entities. These investments are in a wide range of companies and industries emphasizing life sciences and technology. LPC's investments range from multi-year financial commitments to fund growth to special situation financings to long-term strategic capital offering companies' flexibility and consistency. For more information, please visit www.lpcfunds.com.

    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 as amended on Form 10-K/A on January 21, 2020 and 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.

    Contact:

    Tim McCarthy, LifeSci Advisors, LLC

    212.915.2564

     

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  4. 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

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  5. 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

     

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