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Advaxis, Inc. (ADXS)

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0.5700-0.0165 (-2.81%)
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0.5776 +0.01 (1.33%)
After hours: 7:31PM EDT

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Previous Close0.5865
Open0.5988
Bid0.5711 x 1100
Ask0.5777 x 1000
Day's Range0.5600 - 0.6000
52 Week Range0.2640 - 1.5700
Volume3,841,376
Avg. Volume11,188,500
Market Cap68.096M
Beta (5Y Monthly)2.56
PE Ratio (TTM)N/A
EPS (TTM)-0.3270
Earnings DateJun 09, 2021 - Jun 14, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target EstN/A
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  • Advaxis, Inc. Announces $20 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
    GlobeNewswire

    Advaxis, Inc. Announces $20 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

    PRINCETON, N.J., April 12, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS) (the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced it has entered into definitive agreements with two healthcare-focused, institutional investors for the purchase of (i) 17,577,400 shares of common stock , (ii) 7,671,937 pre-funded warrants (the “Pre-Funded Warrants”) to purchase 7,671,937 shares of common stock and (iii) registered common share purchase warrants to purchase 11,244,135 shares of common stock. The Company has also agreed to issue to the investors, in a concurrent private placement, unregistered common share purchase warrants to purchase 14,005,202 shares of the Company’s common stock. Each share of common stock and accompanying common share purchase warrant are being sold together at a combined offering price of $0.7921, and each Pre-funded Warrant and accompanying common warrant are being sold together at a combined offering price of $0.7911, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules. The Pre-Funded Warrants are immediately exercisable, at an exercise price of $0.001, and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. The registered common share purchase warrants will have an exercise price of $0.70 per share, will be immediately exercisable, and will expire five (5) years from the date of issuance. The unregistered common share purchase warrants will have an exercise price of $0.70 per share, will be exercisable fourteen days after the Company increases its authorized share capital, and will expire five (5) years from their initial exercise date (collectively, the “Offering”). The Company plans to use the net proceeds from the offering to fund its continued research and development initiatives in connection with expanding its product pipeline including, but not limited to, investment in its ADXS-HOT program and for general corporate purposes. The Company may also use a portion of the net proceeds to acquire or invest in other businesses, products and technologies. A.G.P./Alliance Global Partners is acting as sole placement agent for the Offering. The Offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-226988) previously filed with the U.S. Securities and Exchange Commission (the “SEC”), and an additional registration statement on Form S-3 filed pursuant to Rule 462(b) under the Securities Act, which became effective upon filing on August 30, 2018. A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: prospectus@allianceg.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering. Copies of the Supplement, the Base Shelf Prospectus and the Registration Statement may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: prospectus@allianceg.com. No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Advaxis 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. 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. 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. Such risks include, but are not limited to: the success and timing of the Company’s clinical trials, including patient accrual; the Company’s ability to develop and commercialize its products; the Company’s ability to identify license and collaboration partners and to maintain existing relationships; the Company’s available cash and its ability to obtain additional funding; and any outcomes from the Company’s review of strategic transactions. 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, as amended, and its periodic reports on Form 10-Q and Form 8-K. 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 whether as a result of new information, future events or otherwise, except as otherwise required by law. Investor ContactTim McCarthyLifeSci Advisors, LLCTim@lifesciadvisors.com(212) 915-2564

  • Advaxis Presents Translational Biomarker Data from Ongoing ADXS-503 Phase 1/2 Lung Cancer Trial at the American Associated for Cancer Research (AACR) 2021 Annual Meeting
    GlobeNewswire

    Advaxis Presents Translational Biomarker Data from Ongoing ADXS-503 Phase 1/2 Lung Cancer Trial at the American Associated for Cancer Research (AACR) 2021 Annual Meeting

    Collaboration with Precision for Medicine to develop novel flow cytometry PD-1 expression assay as a pharmacodynamic biomarker in T cells during PD-1 blockade Assay enables determination of PD-1 expression independent of PD-1 receptor status, accounting for both free and drug-bound PD-1 Results confirm on-mechanism activation of innate and adaptive immune responses in patients with demonstrated clinical benefit from ADXS-503 treatment in combination with pembrolizumab PRINCETON, N.J., April 10, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, and Precision for Medicine, a specialized services company supporting next generation approaches to drug development and commercialization, today announced data on the development of a novel flow immunophenotyping assay to accurately evaluate total PD-1 expression as a pharmacodynamic marker during PD-1 blockade, and translational data demonstrating immune responses correlated to observed clinical benefit from the Company’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA®, presented as a poster at the American Association for Cancer Research (AACR) Annual Meeting 2021. ADXS-503 is the first drug construct from the ADXS-HOT off-the-shelf, 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. “These presented data suggest this novel immunophenotyping assay has the potential to more accurately measure pharmacodynamic biomarkers in immunotherapy,” said Ken Berlin, Chief Executive Officer of Advaxis. “This assay enables the detection of both free and drug-bound PD-1 expression, independent of PD-1 receptor status or interference due to PD-1 blockade, enabling the accurate evaluation of PD-1 expression in patients undergoing treatment with pembrolizumab. We believe this is another important step forward in further understanding immune responses in patients treated with immunotherapy agents, and may provide important translational insights specific to PD-1 expression and immune modulation which may help shape treatment strategies moving forward.” Mr. Berlin continued, “The flow cytometry data confirmed the on-mechanism activation of the innate and adaptive immune systems in patients with observed clinical benefit following treatment with ADXS-503 in combination with pembrolizumab. The demonstrated proliferation and activation of NK cells and CD8 + T cells, plus increased PD-1 expression in diverse immune cells in patients achieving clinical benefit, add to the growing body of evidence which demonstrate the potential of ADXS-503 to re-sensitize or enhance responses to pembrolizumab, even in patients with prior progression. We will continue these analyses with Precision for Medicine on additional patients from our ongoing Phase 1/2 study in NSCLC, and look forward to continued progress as we build upon our previously reported efficacy results which show promising and durable clinical benefit after treatment with ADXS-503, our first off-the-shelf neoantigen immunotherapy candidate.” Key presentation highlights: Poster presentation titled, “Evaluation of total PD-1 expression using multi-color flow cytometry in metastatic non-small cell lung cancer patients treated with multi-neoantigen vector (ADXS-503) alone and in combination of pembrolizumab to assess T-cell & T-cell memory subsets” presented by Dr.Venkat Mohanram, Senior Scientist at Precision for Medicine. A novel multi-color flow cytometry analysis was developed to accurately identify PD-1 expression on peripheral blood mononuclear cells (PBMCs) of NSCLC patients receiving PD-1/PD-L1 blockade therapy with pembrolizumab and ADXS-503No interference in PD-1 detection due to pembrolizumab blockage was observed, enabling the determination of PD-1 expression independent of PD-1 receptor status, with both free and drug-bound PD-1 detectedPreliminary flow cytometry data demonstrated on-mechanism activation of innate and adaptive immune responses to ADXS-503. Three patients from the ongoing Phase 1/2 with demonstrated clinical benefit of stable disease showed: Proliferation and activation of NK cellsIncreased PD-1 expression on circulating CD4+, CD8+ and NK cellsIncreased counts of CD8+ T cells including proliferative, cytotoxic and memory CD8+ T cells 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. Part B with ADXS-503 (1 X108 CFU) in combination with KEYTRUDA® is currently enrolling its efficacy expansion for up to 15 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. Part C, which is evaluating ADXS-503 in combination with KEYTRUDA® (1 X108 CFU + KEYTRUDA®) as a first line treatment for patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy is currently enrolling patients. About ADXS-HOTADXS-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 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 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 Company’s drug product candidates, statements about the Company’s balance sheet position, 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. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA. Investor ContactTim McCarthyLifeSci Advisors, LLCTim@lifesciadvisors.com(212) 915-2564

  • Advaxis Announces Agreement with Columbia University Irving Medical Center to Fund Phase 1 Study of ADXS-504 for the Treatment of Early Prostate Cancer
    GlobeNewswire

    Advaxis Announces Agreement with Columbia University Irving Medical Center to Fund Phase 1 Study of ADXS-504 for the Treatment of Early Prostate Cancer

    Initiation of Phase 1 study in biochemically recurrent prostate cancer anticipated in Q2PRINCETON, N.J., April 05, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced an agreement with Columbia University Irving Medical Center to fund a Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer. The study, expected to begin in Q2 2021, will be the first clinical evaluation of ADXS-504, Advaxis’ off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer. Mark Stein, M.D., associate professor of medicine in the Division of Hematology/Oncology at Columbia University Vagelos College of Physicians and Surgeons, will be the study’s principal investigator. The Phase 1 open-label study will evaluate the safety and tolerability of ADXS-504 monotherapy, administered via infusion, in 9-18 patients with biochemically recurrent prostate cancer, i.e., those with elevation of prostate-specific antigen (PSA) in the blood after radical prostatectomy or radical radiotherapy (external beam or brachytherapy) and who are not currently receiving androgen ablation therapy. The study will also evaluate preliminary clinical and immune responses following treatment with ADXS-504 monotherapy. Nearly 248,530 men in the United States will be diagnosed with prostate cancer in 2021, and approximately 34,130 will die from this disease. Many more men with prostate cancer will experience rising prostate-specific antigen (PSA) levels following local therapy with radical radiotherapy or prostatectomy, a condition known as biochemical recurrence (BCR). BCR is not typically associated with imminent death, and biochemical progression may occur over a prolonged period. Clinicians treating men with BCR thus face a difficult set of decisions in attempting to delay the onset of metastatic disease and death while avoiding over-treating patients whose disease may never affect their overall survival or quality of life. “Currently, men with biochemically recurrent prostate cancer are either monitored for a period of time without intervention or may be started on medicine to decrease the level of testosterone in the body, which can have significant side effects,” said Dr. Stein. “Therefore, we need new approaches to stimulate the body’s immune system to control the prostate cancer. Given the encouraging results from a Phase 2 study of ADXS-PSA, which targets a single-antigen, in combination with KEYTRUDA®, in men with advanced prostate cancer, and emerging signals of potential clinical activity of the Company’s multi-antigen technology in non-small cell lung cancer, we are excited to have the opportunity to explore the potential of ADXS-504 immunotherapy as a novel treatment modality for biochemically recurrent prostate cancer.”ADXS-504 is a novel Lm-based immunotherapy, bioengineered to elicit T cell responses against 24 tumor antigens that include 14 peptide antigens derived from frequently occurring and commonly shared hotspot mutations in patients with prostate cancer and 10 peptide antigens derived from sequence-optimized tumor-associated antigens (TAAs) that are differentially expressed or overexpressed in prostate cancer. ADXS-504 is designed to express multiple tumor antigen targets to which patients may generate a broad set of effector T cells for tumor control. Similar to Advaxis’ other Lm-based immunotherapies, ADXS-504 is expected to induce an innate immune response followed by the adaptive response and modification of the immunosuppressive tumor microenvironment (TME) by reducing regulatory T cells (Tregs) and myeloid-derived suppressor cell (MDSC) frequencies in the TME. Kenneth A. Berlin, President and Chief Executive Officer of Advaxis said, “We are pleased to be working with Columbia University Irving Medical Center to conduct the first clinical evaluation of ADXS-504 in earlier stages of prostate cancer where drug constructs of this type could potentially control micrometastasis efficiently. The strategic decision to transition the ADXS-504 to an investigator-sponsored study at Columbia will provide access to world-class expertise and has the potential to accelerate patient recruitment in order to expedite our clinical progress. We are encouraged by our momentum and look forward to continued progress across our ADXS-HOT program, which also includes ongoing studies in NSCLC in the first line setting and in patients who have progressed on pembrolizumab.” About Advaxis 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. 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. 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. Such risks include, but are not limited to: the success and timing of the Company’s clinical trials, including patient accrual; the Company’s ability to develop and commercialize its products; the Company’s ability to identify license and collaboration partners and to maintain existing relationships; the Company’s available cash and its ability to obtain additional funding; and any outcomes from the Company’s review of strategic transactions. 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, and its periodic reports on Form 10-Q and Form 8-K. 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 whether as a result of new information, future events or otherwise, except as otherwise required by law. 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