SAN DIEGO, June 1, 2017 /PRNewswire/ -- OncoSec Medical
Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing
DNA-based intratumoral cancer immunotherapies, today announced
third quarter and year-to-date financial results ended April 30, 2017.
"We have made significant progress this past quarter in
advancing our clinical and regulatory pathway for
ImmunoPulse® IL-12, which we believe can provide a
meaningful clinical benefit to patients with limited or no
treatment options," said Punit
Dhillon, President and CEO of OncoSec. "With a clinical
collaboration and drug supply agreement for pembrolizumab and FDA
Fast Track designation in hand, we are working diligently on the
site start-up and initiation activities related to our
registration-directed study, which we call PISCES. By pursuing an
accelerated pathway, this puts us in a favorable position to secure
the first approval in the anti-PD-1 non-responder patient
population in advanced melanoma."
Third Quarter and YTD 2017 Financial Results
- For the third quarter of fiscal 2017 and the nine months ended
April 30, 2017, OncoSec reported a
net loss of $4.6 million and
$15.6 million, or $0.22 per share and $0.79 per share, respectively, compared to a net
loss of $6.3 million and $20.3 million, or $0.37 per share and $1.27 per share, respectively, for the same
periods last year.
- The decrease in net loss for the third quarter ended
April 30, 2017, compared with the
same period in 2016, resulted primarily from: (i) a decrease in
research and development expenses, mainly $0.7 million related to clinical trial costs due
to a lower number of patient enrollments in a smaller number of
actively enrolling trials, as well as lower trial management costs;
and, (ii) a decrease of $0.9 million
in stock compensation expense, mainly related to a reduction in the
value of equity compensation awards.
- The decrease in net loss for the nine months ended April 30, 2017, compared with the same period in
2016, resulted primarily from: (i) a decrease in research and
development expenses, mainly $2.1
million related to clinical trial costs and outside services
due to a lower number of patient enrollments in a smaller number of
actively enrolling trials, as well as lower trial management costs,
and lower salary costs of $0.7
million; and, (ii) a decrease of $1.5
million in stock compensation expense.
- There were no revenues for the three and nine months ended
April 30, 2017 or April 30, 2016.
- Research and development expenses were $2.7 million and $8.6
million for the third quarter of fiscal 2017 and the nine
months ended April 30, 2017,
respectively, compared to $3.4
million and $11.1 million for
the same periods in 2016.
- General and administrative expenses were $1.9 million and $6.9
million for the third quarter of fiscal 2017 and the nine
months ended April 30, 2017, compared
to $2.9 million and $9.2 million for the same period in 2016.
- At April 30, 2017, OncoSec had
$16.1 million in cash and cash
equivalents, as compared to $28.7
million of cash and cash equivalents at July 31, 2016. OncoSec, based on its current rate
of cash consumption, estimates it will need additional capital in
the first calendar quarter of 2018 to continue to operate its
business.
Third Quarter 2017 and Recent Highlights
ImmunoPulse® IL-12 Progress
- Presented positive topline results from the primary analysis of
the Phase II combination trial of ImmunoPulse® IL-12 and
pembrolizumab in melanoma patients that were predicted to be
non-responders to anti-PD-1 at the 2017 ASCO-SITC Clinical
Immuno-Oncology Symposium. Data showed an objective response of 43%
and a best overall response rate (ORR) of 48% at 24 weeks; ORR of
33% in patients with prior checkpoint therapy;
- Granted FDA Fast Track designation for ImmunoPulse®
IL-12 for the treatment of metastatic melanoma following
progression on pembrolizumab or nivolumab;
- Completed clinical trial collaboration and supply agreement for
pembrolizumab for the Phase II registration-directed trial,
referred to as PISCES; and,
- Granted international nonproprietary name (INN) for pIL-12-
"tavokinogene telseplasmid."
Strategic Collaborations
- Initiated a Technology Access Program collaborations with
Inhibrx and another undisclosed company.
R&D and Pipeline Expansion
- Presented positive preclinical data demonstrating the latest
developments of the Company's gene delivery platform in a murine
melanoma model at the American Association of Cancer Research
(AACR) Annual Meeting;
- Presented intratumoral electroporation-mediated IL-12 gene
therapy data showing enhanced tumor immunogenicity at the Keystone
Symposia conference;
- Continued development of novel multi-gene constructs and
advancing new preclinical candidates that target multiple cancer
immune regulating mechanisms in solid tumors; and,
- Advanced tumor targeted delivery technologies focused on
treating visceral tumor applications.
2017 Development Milestones
- PISCES a Phase II study of ImmunoPulse® IL-12 in
combination with anti-PD-1 in melanoma patients that progress on
anti-PD-1 therapies, will be open for enrollment in June 2017;
- Availability of top-line data for PISCES targeted for fourth
quarter of 2017;
- Patients predicted to be non-responders treated with the
combination with tavokinogene telseplasmid and pembrolizumab;
- Assess long-term follow-up data from first cohort of patients
(n=22) enrolled in Phase II Investigator Sponsored Trial assessing
combination of ImmunoPulse® IL-12 and pembrolizumab in
melanoma patients; and,
- Establish key collaborations and expand the use of our
technology through the technology access program using our novel
Tissue Responsive Adaptive Controlled Electroporation (TRACE)
enabled delivery technology.
About OncoSec Medical Incorporated
OncoSec is a
biotechnology company developing DNA-based intratumoral
immunotherapies with an investigational technology,
ImmunoPulse®, for the treatment of cancer.
ImmunoPulse® is designed to enhance the local delivery
and uptake of DNA-based immune-targeting agents, such as IL-12. In
Phase I and II clinical trials, ImmunoPulse® IL-12 has
demonstrated a favorable safety profile and evidence of anti-tumor
activity in the treatment of various solid tumors as well as a
systemic immune response. OncoSec's lead program,
ImmunoPulse® IL-12, is currently in clinical development
for several indications, including metastatic melanoma and
triple-negative breast cancer. The program's current focus is on
the significant unmet medical need in patients with melanoma who
are refractory or non-responsive to anti-PD-1/PD-L1 therapies. In
addition to ImmunoPulse® IL-12, the Company is also
identifying and developing new immune-targeting agents for use with
the ImmunoPulse® platform. For more information, please
visit www.oncosec.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains "forward-looking
statements" within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995. Forward-looking statements can be
identified by words such as "objective," "expect," and similar
references to future periods.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they 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.
Potential risks and uncertainties that could cause actual results
to differ from those predicted include, among others, the
following: uncertainties inherent in pre-clinical studies and
clinical trials, such as the ability to enroll patients in clinical
trials and the risk of adverse events; unexpected new data, safety
and technical issues; our ability to raise additional funding
necessary to fund continued operations; and the other factors
discussed in OncoSec'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
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.
OncoSec Medical
Incorporated
Condensed Consolidated Balance Sheet and Condensed Balance
Sheet
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
April 30,
|
|
July 31,
|
|
|
2017
|
|
2016
|
Assets
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
$
|
16,106,338
|
$
|
28,746,224
|
Prepaid expenses and
other current assets
|
|
987,160
|
|
671,184
|
Total Current
Assets
|
|
17,093,498
|
|
29,417,408
|
Property and
equipment, net
|
|
2,493,784
|
|
2,799,930
|
Other long-term
assets
|
|
384,256
|
|
189,309
|
Total
Assets
|
$
|
19,971,538
|
$
|
32,406,647
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
2,644,259
|
$
|
3,223,327
|
Accrued
compensation
|
|
168,234
|
|
242,924
|
Total Current
Liabilities
|
|
2,812,493
|
|
3,466,251
|
Other long-term
liabilities
|
|
1,196,716
|
|
887,292
|
Total
Liabilities
|
|
4,009,209
|
|
4,353,543
|
|
|
|
|
|
Commitments and
Contingencies
|
|
|
|
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
|
Common stock
authorized - 160,000,000 common shares with a par value of
$0.0001, common stock issued and outstanding — 21,168,194 and
18,036,263 common shares as of April 30, 2017 and
July 31, 2016, respectively
|
|
25,582
|
|
25,269
|
Additional paid-in
capital
|
|
93,195,870
|
|
88,233,965
|
Warrants issued and
outstanding — 9,494,740 and 12,859,286 warrants as of April 30,
2017 and July 31, 2016, respectively
|
|
11,780,307
|
|
13,288,527
|
Accumulated other
comprehensive income
|
|
7,094
|
|
-
|
Accumulated
deficit
|
|
(89,046,524)
|
|
(73,494,657)
|
Total Stockholders'
Equity
|
|
15,962,329
|
|
28,053,104
|
Total Liabilities and
Stockholders' Equity
|
$
|
19,971,538
|
$
|
32,406,647
|
|
|
|
|
|
OncoSec Medical
Incorporated Condensed Consolidated Statements of
Operations and Condensed Statements of Operations
(unaudited)
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
April 30,
2017
|
|
April 30,
2016
|
|
April 30,
2017
|
|
April 30,
2016
|
Revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
Expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
2,656,073
|
|
3,376,757
|
|
8,638,423
|
|
11,149,652
|
General and
administrative
|
|
1,904,899
|
|
2,874,362
|
|
6,912,053
|
|
9,174,406
|
Loss before income
taxes
|
|
(4,560,972)
|
|
(6,251,119)
|
|
(15,550,476)
|
|
(20,324,058)
|
Provision for income
taxes
|
|
-
|
|
290
|
|
1,391
|
|
2,462
|
Net loss
|
$
|
(4,560,972)
|
$
|
(6,251,409)
|
$
|
(15,551,867)
|
$
|
(20,326,520)
|
Basic and diluted net
loss per common share
|
$
|
(0.22)
|
$
|
(0.37)
|
$
|
(0.79)
|
$
|
(1.27)
|
Weighted average
shares used in computing basic and diluted net loss per common
share
|
|
20,704,393
|
|
16,971,214
|
|
19,809,739
|
|
15,955,116
|
OncoSec Medical
Incorporated Condensed Consolidated Statements of
Comprehensive Loss and Condensed Statements of Comprehensive Loss
(unaudited)
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
|
|
|
April 30,
2017
|
April 30,
2016
|
|
April 30,
2017
|
April 30,
2016
|
|
|
|
|
|
|
Net Loss
|
$
(4,560,972)
|
$
(6,251,409)
|
|
$
(15,551,867)
|
$
(20,326,520)
|
Foreign currency
translation adjustments
|
7,080
|
-
|
|
7,094
|
-
|
Comprehensive
Loss
|
$
(4,553,892)
|
$
(6,251,409)
|
|
$
(15,544,773)
|
$
(20,326,520)
|
OncoSec Medical
Incorporated Condensed Consolidated Statement of Cash
Flows and Condensed Statement of Cash Flow
(unaudited)
|
|
|
|
|
|
Nine Months
Ended
|
|
|
April 30,
2017
|
|
April 30,
2016
|
Operating
activities
|
|
|
|
|
Net loss
|
$
|
(15,551,867)
|
$
|
(20,326,520)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
Depreciation and
amortization
|
|
284,319
|
|
253,664
|
Loss on disposal of
property and equipment
|
|
-
|
|
41,989
|
Stock-based
compensation
|
|
3,378,991
|
|
4,676,215
|
Changes in operating
assets and liabilities:
|
|
|
|
|
Decrease(Increase) in
prepaid expenses and other current assets
|
(315,976)
|
|
532,214
|
Decrease(Increase) in
other long-term assets
|
|
(163,542)
|
|
25,286
|
Decrease(Increase) in
accounts payable and accrued liabilities
|
|
(579,068)
|
|
461,617
|
Increase (decrease)
in accrued compensation
|
|
(74,690)
|
|
15,724
|
Increase in other
long-term liabilities
|
|
309,424
|
|
573,654
|
Net cash used in
operating activities
|
|
(12,712,409)
|
|
(13,746,157)
|
Investing
activities
|
|
|
|
|
Purchases of property
and equipment
|
|
(9,578)
|
|
(1,156,420)
|
Net cash used in
investing activities
|
|
(9,578)
|
|
(1,156,420)
|
Financing
activities
|
|
|
|
|
Proceeds from
issuance of common stock and warrants
|
|
-
|
|
7,500,010
|
Payment of financing
and offering costs
|
|
-
|
|
(613,915)
|
Proceeds from
exercise of warrants
|
|
30,950
|
|
-
|
Proceeds from
issuance of common stock
|
|
44,057
|
|
-
|
Net cash provided by
financing activities
|
|
75,007
|
|
6,886,095
|
Effect of exchange
rate changes on cash
|
|
7,094
|
|
-
|
Net (decrease) in
cash
|
|
(12,639,886)
|
|
(8,016,482)
|
Cash and cash
equivalents, at beginning of period
|
|
28,746,224
|
|
32,035,264
|
Cash and cash
equivalents, at end of period
|
$
|
16,106,338
|
$
|
24,018,782
|
|
|
|
|
|
Supplemental
disclosure for cash flow information:
|
|
|
|
|
Cash paid during the
period for:
|
|
|
|
|
Interest
|
$
|
-
|
$
|
-
|
Income
taxes
|
$
|
1,391
|
$
|
2,462
|
|
|
|
|
|
Noncash investing and
financing transaction:
|
|
|
|
|
Fair value of
placement agent warrants issued in the public offering
|
$
|
-
|
$
|
242,143
|
Issuance of common
stock in connection with a contractual
agreement
|
$
|
-
|
$
|
55,500
|
Noncash expiration of
warrants
|
$
|
1,479,274
|
$
|
431,981
|
R&D Equipment in
use but financed through accounts payable and accrued
liabilities
|
$
|
-
|
$
|
393,718
|
CONTACTS:
Investor Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
investors@oncosec.com
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SOURCE OncoSec Medical Incorporated