Advaxis, Inc. (NASDAQ: ADXS) is a late-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. Advaxis has four programs in various stages of clinical development: ADXS-HPV for cervical cancer; ADXS-NEO, personalized neoantigen-directed therapy for multiple cancers; ADXS-503 for non-small cell lung cancer, from its ADXS-HOT off-the-shelf neoantigen-directed program; and ADXS-PSA for prostate cancer.
Key findings from the combination arm of KEYNOTE-046 include the following:
- The majority of treatment-related adverse events consisted of transient and reversible Grade 1-2 chills/rigors, fever, hypotension, nausea and fatigue. The combination of ADXS-PSA and pembrolizumab has been well-tolerated, to date, with no additive toxicity observed.
- Median overall survival was 21.1 months at data cut-off (February 1, 2019) (95% CI, range 16.0 months to not-yet-reached) in this dataset of 37 patients.
- Correlative immune analyses showed T-cell responses against PSA in 75% of subjects and antigen spreading in 85% of subjects.
- Broader immune stimulation, including B-cell activation, was observed in the combination arm (n=37) than in the ADXS-PSA monotherapy arm (n=13).
Management commentary:
“We are very excited to report the updated ADXS-PSA data today at the AACR meeting,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “These data show the clinical potential of ADXS-PSA both alone and in combination with KEYTRUDA®. It is meaningful that the combination has been well-tolerated in the study population because dose-related toxicities can present challenges for cancer patients, and an additive therapy with a favorable safety and tolerability profile may offer an attractive option for clinicians if developed further in this indication.” He concluded, “Based on the prolonged survival data and strong safety profile to date, we believe that continued clinical development of ADXS-PSA in combination with KEYTRUDA® is warranted and represents a potentially significant opportunity for Advaxis.”
The company’s Board of Directors approved a one-for-fifteen (1-for-15) reverse stock split of its common stock that became effective March 29, 2019, upon the filing of a Certificate of Amendment to its Certificate of Incorporation with the Secretary of the State of Delaware.
Clinical Pipeline Overview:
Upcoming Milestone/Catalysts: Multiple Catalysts (Read-outs) Anticipated in 2019
Outlook over the near to medium term: The company expects 2019 will be an important and eventful year for Advaxis due to the amount of information we anticipate generating from its programs and it looks forward to reporting data throughout the year.
To ensure its various programs progress to data readout, the management is continually evaluating ways to increase its cash runway by controlling expenses and generating cash from potential out-licensing and/or financing transactions. ADXS is an emerging player in the anti-tumor immunity segment, and 2019 is expected to be a remarkable year for biotech space and oncology/cancer segment will likely continue to dominate the industry.
Updates on the progress of the Company’s clinical pipeline include:
- Cancer Type-Focused Hotspot/Off-the-Shelf Neoantigen Therapies (ADXS-HOT) – The Company initiated its first clinical trial using a novel and proprietary approach to cancer immunotherapy that targets hotspot mutations, cancer testis antigens, and oncofetal antigens. The first drug candidate from this program, ADXS-503, is designed to treat all types of non-small cell lung cancer and is now enrolling patients. The end of June 2019 anticipates Safety, tolerability and immune correlative data from this Phase1/2 study.
- Personalized, Neoantigen-Directed Therapy (ADXS-NEO) – The Company continues to enroll patients in Phase 1 dose-escalation study with its personalized antigen delivery program using whole-exome sequencing of a patient’s tumor to identify personal neoantigens. Early immune response data from the first cohort of this study were presented last month at the Immuno-Oncology 360o Conference, and safety, tolerability and immune correlative data from the first two cohorts will be presented at the American Association of Cancer Research (AACR) Annual Meeting on March 31, 2019.
- Prostate Cancer (ADXS-PSA) – Previously reported data from a Phase 1/2 study of ADXS-PSA in combination with KEYTRUDA® (pembrolizumab) demonstrated a manageable safety profile (mostly grade 1-2 treatment-related adverse events), in a cohort of 37 heavily pretreated metastatic castration-resistant prostate cancer patients and showed a greater level of clinical activity compared to monotherapy. The Company will be presenting updated clinical and biomarker data on this program at the AACR Annual Meeting on April 1, 2019.
- Cervical Cancer (ADXS-HPV) – In January 2019 the Company announced that the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the Company’s Phase 3 AIM2CERV clinical trial for axalimogene filolisbac (AXAL) in high-risk locally advanced cervical cancer. The partial hold relates to FDA’s request for additional information pertaining to certain AXAL chemistry, manufacturing, and controls (CMC) matters. The FDA did not cite any safety issues related to the trial and all currently enrolled patients are continuing to receive treatment. The Company has submitted its initial response to the request for additional CMC information and is currently in discussions with the Agency. In parallel, Advaxis is in discussions with the Agency regarding the Company’s request, made late in 2018, to include a second interim analysis for efficacy. The Company is working diligently to reach a resolution with the Agency on both of these matters.
Key and unique differentiating factor for the Company:
- Unique Platform Yielding Broad Portfolio of I-O Drug Candidates: Listeria monocytogenes (Lm) platform optimized so as to generate a broad portfolio of I-O drug candidates across a large number of solid tumor types
- Validation in the Clinic: Demonstrated a manageable safety profile along with clinical activity – nearly 500 patients treated to date.
- Neoantigen-Directed Drug Candidates with High Tumor Immunogenicity Potential: Innovative, personalized and off-the-shelf neoantigen-directed drug candidate with preliminary clinical data demonstrating the potential for best-in-class CD8+ T cell response
- Strong Intellectual Property Portfolio: Over 400 patents/patent applications
- Experienced Management Team: Chief Executive Officer, Chief Financial Officer, and Chief Medical Officer joined within the past year
Industry potential:
- Annual, Worldwide Peak Revenue Opportunity of $500M for AXAL in High-Risk Locally Advanced Cervical Cancer
- Market Opportunity in the U.S and Europe – Estimated Annual Revenues
- Combined Worldwide Estimated Market Opportunity of ~$500M
- 5-year survival rates are poor for high-risk locally advanced patients; represents an area of great unmet need
Financial Results for First Quarter Ended
January 31, 2019
- Research and development expenses for the first quarter of the fiscal year 2019 were $6.7 million, compared with $16.8 million for the first quarter of the fiscal year 2018. The $10.1 million decreases were primarily attributable to costs incurred during the last fiscal year related to the Company’s Marketing Authorization Application in Europe and cost controls initiated in the latter part of the fiscal year 2018. Additionally, there was a decrease in clinical trial expenses resulting from the partial clinical hold on AIM2CERV and winding down of several older studies.
- Net income for the first quarter of the fiscal year 2019 was $12.8 million or $0.18 per share, compared with a net loss for the first quarter of the fiscal year 2018 of $20.5 million or $0.49 per share. Net cash used during the first quarter ended January 31, 2019, was $12.4 million.
Key Stock Influences:
- Successful completion of the upcoming catalysts would lead future direction for the company. Any adversities related to these upcoming milestones might adversely impact the overall investor sentiments.
- ADXS is still an early stage entity and has not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it.
- ADXS has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.
Stock Chart:
- On Monday, April 1st, 2019, ADXS is trading at $8.06 on an above average volume of 8.4 million shares exchanging hands. Market capitalization is $672.335 million. The current RSI is 61.81
- In the past 52 weeks, shares of ADXS have traded as low as $2.71 and as high as $30.60
- At $8.05, shares of ADXS are trading above its 50-day moving average (MA) at $5.92 and below its 200-day MA at $11.80
- The present support and resistance levels for the stock are at $3.98 & $7.56 respectively.
Disclaimer
Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Traders News Source has not been compensated for this report by anyone and the opinions if any are that of the author Vikas Agrawal, CFA. Author’s Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I, wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in the article.
This web site, published by TNS LLC, and is an investment newsletter that is built on the premise of assisting individual investors in learning about investing. Our goal as publishers of financial information is to provide research and analysis of investments to our subscribers. TNS LLC does not give buy or sell recommendations. We do purchase distribution rights from analyst, financial writers and bloggers for a fee that may be licensed to issue price targets and recommendations. Furthermore, we encourage you to speak to a licensed professional prior to making an investment in any type of publicly traded security.
We do sell advertising to other companies including brokerage firms, web sites, publicly traded issuers, investor relations firms, and investment publications, among others. TNS LLC makes no warranty as to the policies of these organizations, and in no way endorses their offers, services, or the content of their advertisements.
When an advertiser is a publicly traded company or a third party acting on behalf of a public company, we fully disclose all compensation in the email advertisement. Such disclosure is included in a disclosure statement in each of the advertisements sent via email.
17B Disclosure
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: TNS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operator’s owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.
TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur.
Understand there is no guarantee past performance will be indicative of future results. In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.
