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.
The company’ share is trading with robust volumes as it announces updated data from the Phase 1/2 KEYNOTE-046 study in metastatic, castration-resistant prostate cancer (mCRPC). This trial is being conducted in conjunction with Merck (known as MSD outside the U.S. and Canada) and is evaluating ADXS-PSA, one of Advaxis’ Listeria monocytogenes (Lm)-based immunotherapies, alone and in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. The results are being presented at AACR in Atlanta.
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).
“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
- 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.
- 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.
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