OncoSec Medical Announces YTD Results for Fiscal Year End 2014
October 10 2014 - 6:02AM
Business Wire
OncoSec Medical Inc. (OTCQB: ONCS), a company developing
DNA-based intratumoral cancer immunotherapies, today announced
financial results for the fiscal year ended July 31, 2014.
FINANCIAL RESULTS
For the fiscal year ended July 31, 2014, OncoSec Medical
reported a net loss of $12.0 million, or $0.06 per share, compared
to a net loss of $7.2 million, or $0.07 per share, for the same
period last year. The increase in net loss attributable to common
stockholders for the year ended July 31, 2014, compared with the
same period in 2013, resulted primarily from (i) an increase in
salary related expenses (inclusive of stock-based compensation) due
to increased headcount as we continue to grow our company in
support of our corporate goals and (ii) an increase in outside
services costs (sponsored research, clinical development
consulting, and corporate development/communications consulting) as
we continue to expand our research and development operations and
corporate infrastructure. There were no revenues for fiscal year
ended July 31, 2014 or July 31, 2013.
Research and development expenses were $5.8 million for the
fiscal year ended July 31, 2014, compared to $3.2 million for the
same period in 2013. General and administrative expenses were $6.2
million for the fiscal year ended July 31, 2014, compared to $3.9
million for the same period in 2013.
At July 31, 2014, we had $37.9 million in cash and cash
equivalents, as compared to $5.0 million of cash and cash
equivalents at July 31, 2013. We expect these funds to be
sufficient to allow us to continue to operate our business for at
least the next 12 months.
RECENT HIGHLIGHTS IN FISCAL YEAR 2015
It has been a year of tremendous progress thus far with the
expansion of our team and R&D capabilities. As we prepare for
more success in the coming months, it is important to note the
significant advancements that have brought us to this point. Below
is a summary of noteworthy events in fiscal year 2015 to-date.
- Dr. Holbrook Kohrt, M.D., Ph.D., was
appointed to our Scientific Advisory Board. Dr. Kohrt is an
Assistant Professor at Stanford Cancer Institute, and currently
investigates novel therapeutic strategies to enhance anti-tumor
immunity. Dr. Kohrt is a leader in the research of intratumoral
immunotherapies, and his expertise will be pivotal in the
development of new immune-modulating agents for intratumoral
therapy.
- Dr. Mai H. Le, M.D., was appointed
Chief Medical Officer. Dr. Le has a strong background in drug
development, with extensive experience in clinical research and
regulatory affairs. Prior to joining OncoSec, Dr. Le was Medical
Director at Calithera Biosciences, Inc., where she formulated and
launched the early clinical development plans for a novel small
molecule inhibitor of glutaminase for a variety of solid and
hematological tumor indications. Furthermore, her work at Proteolix
and, later, Onyx Pharmaceuticals, was critical to the accelerated
approval of carfilzomib (Kyprolis®), a second-generation proteasome
inhibitor for the treatment of relapsed/refractory multiple
myeloma.
- Dr. Robert H. Pierce, M.D., was
appointed Chief Scientific Officer and Global Head of R&D, and
Tu Diep, M.Sc., was appointed Vice President of Operations.
- Sheela Mohan-Peterson, J.D., M.S., was
appointed General Counsel and Corporate Secretary. Ms.
Mohan-Peterson will be responsible for leading the Company’s legal
strategy and guiding the continued expansion of its intellectual
property portfolio. She has spent more than 27 years working in the
pharmaceutical and biotech industries, most recently as a Senior
Patent Counsel with Merck & Co., Inc.
- On September 28, 2014, we presented our
latest correlative data on IL-12 electroporation at the ESMO 2014
Congress. These data demonstrate the ability of intratumoral IL-12
electroporation to generate a systemic anti-tumor immune response,
and provide strong support for moving forward with a combination of
intratumoral IL-12 electroporation and an anti-PD1
therapeutic.
FISCAL YEAR 2014 HIGHLIGHTS
In December of 2013, Dr. Robert H. Pierce, M.D., was appointed
to our senior management team. Dr. Pierce joined OncoSec from Merck
Research Labs, where he spent almost seven years leading a
20-person team dedicated to developing disease-oriented and
tissue-based translational medicine platforms. Most notably Dr.
Pierce was a key member of the global development team behind
Merck’s recently approved “breakthrough” immunotherapy for
unresectable melanoma, pembrolizumab (MK-3475). As Executive
Director at Merck Research Labs for almost 7 years, he was
responsible for contributions to multiple successful IND
applications, including critical biomarker development programs
such as the anti-PD-L1 immunohistochemistry assay supporting
Merck’s Phase I and II pembrolizumab (MK-3475) clinical trials. Dr.
Pierce has been the driving force behind OncoSec’s position as a
leader in developing intratumoral immune-modulating therapies.
The year continued with the announcement of numerous clinical
updates:
- On October 8, 2013, we announced our
intent to evaluate the potential of combining intratumoral IL-12
electroporation with immune-modulating checkpoint inhibitor
antibodies like anti-PD-1, anti-PD-L1 and anti-CTLA-4. Based on a
preliminary preclinical safety study in mice, conducted by Dr.
Richard Heller at Old Dominion University, the combination of
intratumoral IL-12 electroporation with these immune-modulating
agents appeared to be safe.
- On March 12, 2014, we announced the
expansion of our Phase 2 melanoma trial, with plans to evaluate an
increased dosage frequency in up to 21 patients. This expansion was
warranted by the encouraging safety profile observed in studies
thus far.
- On April 7, 2014, we announced the
relaunch of our Phase 2 cutaneous T-cell lymphoma study under a
protocol amendment. Enrollment was expanded to Stanford University,
a renowned center of excellence that is regarded as having a large
CTCL patient population and experience investigating novel
therapies for this disease. Additionally, it was announced that Dr.
Yuon Kim, M.D., would serve as principal investigator for the
Stanford University study. Dr. Kim is an internationally renowned
expert in cutaneous lymphomas and director of the multidisciplinary
cutaneous lymphoma program at Stanford University Medical
Center.
- On June 2, 2014, we presented positive
interim data from our Phase 2 melanoma study at the 2014 ASCO
Annual Meeting. The poster was presented by Adil Daud, M.D.,
OncoSec’s Chief Clinical Strategist and Principal Investigator of
the Phase 2 melanoma study. As well, the abstract was selected for
presentation during a poster highlights session for melanoma/skin
cancers, which was led by Axel Hauschild, M.D., Ph.D. At the time
of this interim analysis, 28 patients were evaluable for objective
response rate (ORR). Best ORR was reported and evaluated using a
modified RECIST1.1 criteria. Key data are listed below.- 32% of
evaluable patients achieved objective response- 11% of evaluable
patients achieved complete response- 59% of evaluable patients
achieved systemic response, defined as regression in at least one
non-injected tumor.These data demonstrate the clinical benefits of
ImmunoPulse and support the continued development of DNA IL-12 with
electroporation, and further evaluation as a potential combination
therapy with other immunomodulatory therapies.
- On June 10, 2014, we closed a $16
million registered direct offering. This was the largest offering
in company history, and provided us with support to begin expanding
our R&D and pre-clinical efforts, while continuing to advance
our ongoing programs forward toward commercialization. To further
develop and advance a differentiated immuno-oncology pipeline, we
added some notable new faces to the OncoSec team.
- Dr. Jean S. Campbell, Ph.D., was
appointed Executive Director of Research and Development. Dr.
Campbell was tasked with leveraging her considerable expertise in
cancer biology and signal transduction to investigate immune
tolerance in cancer. Concurrently, we announced the expansion of
our R&D facilities with dedicated laboratory space at the
Icogenex Bioincubator in Seattle as well as expanded research
capabilities in San Diego.
- Dr. Adil Daud, M.D., was appointed
Chief Clinical Strategist. Dr. Daud is a nationally recognized
expert in early-phase drug development in skin cancer and solid
tumors, and a longstanding member of OncoSec’s Melanoma Advisory
Board. In this expanded role, he was tasked with advising on
protocol and development, liaising with key stakeholders and
representing the company at conferences and other important
events.
- Dr. Soldano Ferrone, M.D., Ph.D., was
appointed to the Company’s Scientific Advisory Board. Dr. Ferrone
is an internationally renowned expert in tumor immunology, whose
results have been described in over 600 peer-reviewed journal
publications.
“I am extremely excited about the progress we made in fiscal
year 2014, with the addition of several key hires, meeting
important clinical milestones and strengthening our balance sheet,”
said Punit Dhillon, President and CEO of OncoSec Medical. “We now
have the infrastructure and resources in place to take our R&D
efforts to the next level, while continuing to advance our
product-differentiated immuno-oncology pipeline. The moves we made
this year should solidify our place in the immunotherapy landscape
by redefining the role of intratumoral-based approaches, and set us
up for continued success in fiscal year 2015 and beyond.”
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biotechnology company developing its
ImmunoPulse cancer immunotherapy. OncoSec Medical's core technology
is designed to enhance the local delivery and uptake of
DNA-based immune-targeting agents like DNA IL-12. Clinical studies
using DNA IL-12 with electroporation to-date have demonstrated an
acceptable safety profile and preliminary evidence of anti-tumor
activity in the treatment of various skin cancers, as well as the
potential to initiate a systemic immune response without the
systemic toxicities associated with other treatments. OncoSec's
lead program using DNA IL-12 with electroporation in the treatment
of metastatic melanoma is currently in Phase 2 development. The
company is focused on identifying and developing new
immune-targeting agents, investigating additional tumor
indications, and evaluating combination-based immunotherapy
approaches with DNA IL-12 or other immune-targeting agents. For
more information, please visit www.oncosec.com.
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this release that are not historical facts
may be considered such “forward-looking statements.”
Forward-looking statements are based on management’s current
preliminary expectations and are subject to risks and
uncertainties, which may cause our results to differ materially and
adversely from the statements contained herein. Some of the
potential risks and uncertainties that could cause actual results
to differ from those predicted include our ability to raise
additional funding, our ability to acquire, develop or
commercialize new products, uncertainties inherent in pre-clinical
studies and clinical trials, unexpected new data, safety and
technical issues, competition, and market conditions. These and
additional risks and uncertainties are more fully described in
OncoSec Medical’s filings with the Securities and Exchange
Commission. Undue reliance should not be placed on forward-looking
statements, which speak only as of the date they are made. OncoSec
Medical disclaims any obligation to update any forward-looking
statements to reflect new information, events or circumstances
after the date they are made, or to reflect the occurrence of
unanticipated events.
Investor Relations:OncoSec Medical Inc.Jordyn Kopin,
855-662-6732investors@oncosec.comorPublic Relations:Dian Griesel,
Int’l.Laura Radocaj, 212-825-3210lradocaj@dgicomm.com
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