OncoSec Medical Incorporated (NASDAQ: ONCS) is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer.
On October 25th, the company released financial results for the fourth quarter and fiscal year ended July 31, 2017. In the quarter, ONCS made significant progress in advancing the development of its lead clinical program, ImmunoPulse® IL-12, which it believes could provide a meaningful clinical benefit to metastatic melanoma patients with limited or no treatment options.
The company remains focused on advancing its PISCES/KEYNOTE-695 registration-directed trial to address this significant unmet medical need through an innovative accelerated pathway.
Company’s clinical development plans are progressing fast, and ONCS is scheduled for Late-breaking poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) 32nd 2017 Annual Meeting to be held in National Harbor, MD on November 8-12, 2017.
Immunotherapy is a very hot topic in cancer at the moment, but there are no drugs on the markets that include this sort of inducing technology. Therefore, if ONCS can get this one on the market, it could be a breakthrough in the space.
ImmunoPulse® IL-12: The Next Innovation for Oncology:
There are the potential upside catalysts for the company and, if news hits press favorably, the stock of the company will be on a growth trajectory. Even if it misses, the subsequent dip in share price will serve as an option to make a position for the eventual upside run.
Several equities research analysts recently issued favorable reports on ONCS shares. The analyst’s forecasts oscillate between $5.00 to $6.00. On average, the consensus target is $5.33 in the next year.
About the company: OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer.
Pipeline:
ImmunoPulse® IL-12 for stage III/IV relapsed/refractory melanoma positioned for accelerated approval.
- Initial data mid-2018 seek feedback on accelerated approval
- Potential approval in 2019 via accelerated pathway
- Global PISCES trial in melanoma
ImmunoPulse IL-12 + checkpoint inhibitor in low-TIL (cold) at 50% BORR
- Opportunity to expand 1st line anti-PD-1 response beyond 30-35%
ImmunoPulse IL-12 converts checkpoint inhibitor non-responders to responders Ø60-70% of melanoma patients do not respond to checkpoint inhibitors 1st line
Present Trials:
Anticipated near-term milestones:
Other recent highlights:
- Presented positive Phase 2 data with ImmunoPulse IL-12 as monotherapy and in combination with pembrolizumab at the 2017 9th World Congress of Melanoma – A Joint Meeting of the Society for Melanoma Research.
- Initiated global, open-label, registration-directed clinical trial, PISCES/KEYNOTE-695, of ImmunoPulse IL-12 in combination with pembrolizumab.
- Enrolling patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy.
- ImmunoPulse IL-12 granted Fast Track and Orphan Drug Designation in the U.S.
- Clinical trial collaboration and supply agreement with Merck (known as MSD outside the US and Canada); attained KEYNOTE status.
- Corporate Highlights: Added industry veterans Dr. Annalisa Jenkins, MBBS, FRCP and Daniel J. O’Connor to the Board of Directors; Initiated a Technology Access Program collaboration with Jounce Therapeutics; and, Raised and obtained commitments for $8.1 Million in offerings priced at or above market price.
Q4 and FYE 2017 Financial Results:
- There were no revenues for the fiscal years ended July 31, 2017, or July 31, 2016.
- At July 31, 2017, OncoSec had $11.4 million in cash and cash equivalents, as compared to $28.7 million of cash and cash equivalents at July 31, 2016. OncoSec expects these funds to be sufficient to allow it to continue to operate its business in the third calendar quarter of 2018.
- For the fourth quarter of fiscal 2017 and the fiscal year ended July 31, 2017, OncoSec reported a net loss of $5.8 million and $21.4 million, or $0.28 per share and $1.06 per share, respectively, compared to a net loss of $6.6 million and $26.9 million, or $0.39 per share and $1.63 per share, respectively, for the same period last year.
- Upcoming Results: OncoSec Medical Incorporated is likely to release their next quarterly earnings announcement on Thursday, December 14th, 2017
Key risk factors and potential stock drivers:
The company is optimistic about the positive outcome of the SITC meeting. This meeting will be a critical catalyst for the company going forward.
Notwithstanding promising data and partnerships, ONCS does not have a product yet approved by FDA. There is a risk that their potential drugs might fail during the clinical trials.
The outcome of the upcoming milestones/catalysts could be the near-term trigger for the company. Any non-favorable developments could impinge the business and financial risk profile of the company.
The company may experience financial, regulatory, or operational difficulties, which may impair its ability to commercialize their drug products.
Stock Chart:
On Friday, November 3rd, 2017, ONCS closed at $1.32 on an above average volume of 1.62 million shares exchanging hands. Market capitalization is $39.08 million. The current RSI is 63.55
In the past 52 weeks, shares of ONCS have traded as low as $0.88 and as high as $1.90
At $1.32, shares of ONCS are trading above its 50-day moving average (MA) at $1.07 and above its 200-day MA at $1.14 as well.
The present support and resistance levels for the stock are at $1.24 & $1.43 respectively.
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