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.
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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.
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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.
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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.
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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.
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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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Copyright Business Wire 2014