SAN DIEGO, Oct. 13, 2016 /PRNewswire/ -- OncoSec
Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company
developing DNA-based intratumoral cancer immunotherapies, today
announced financial results for the fourth quarter and fiscal year
ended July 31, 2016.
"During the fourth quarter, we continued to advance the
development of our lead clinical program, ImmunoPulse®
IL-12, focused on the anti-PD1 non-responsive patient population in
melanoma. The development of ImmunoPulse® IL-12 in
combination with an anti-PD1 checkpoint inhibitor represents a
potential immunotherapy for melanoma patients that are progressing
on anti-PD1 therapy," noted Punit
Dhillon, President and Chief Executive Officer. "We
have enrolled over 20 patients in our Phase II combination clinical
study of ImmunoPulse® IL-12 with Merck's
KEYTRUDA® (pembrolizumab) in melanoma patients that are
considered non-responders to anti-PD1, and OncoSec remains on track
to announce interim data from approximately 15 of these patients at
a three-month follow-up later this quarter. Subject to these
interim results and discussions with the U.S. Food and Drug
Administration, we expect to submit a registration directed study
design for ImmunoPulse® IL-12 by the end of 2016.
We have also continued to expand our research pipeline and broaden
our engineering efforts relating to new devices that will be
launched with our next clinical candidate. We look forward to
discussing research and pre-clinical updates and timing data and
clinical development milestones relating to our Melanoma program on
our conference call and webcast on October
13th."
FINANCIAL RESULTS
For the fourth quarter
of fiscal 2016 and the fiscal year ended July 31, 2016, OncoSec reported a net loss of
$6.6 million and $26.9 million, or $0.39 per share and $1.63 per share, respectively, compared to a net
loss of $6.5 million and $21.2 million, or $0.48 per share and $1.67 per share, respectively, for the same
period last year. The increase in net loss for the year ended
July 31, 2016, compared with the same
period in 2015, resulted primarily from (i) the progression of its
clinical trials, (ii) consulting services costs to support its
device development and clinical activities, (iii) facility costs
related to its new corporate headquarters, and (iv) stock-based
compensation expense. There were no revenues for the fiscal years
ended July 31, 2016 or July 31, 2015.
Research and development expenses were $3.7 million and $14.8
million for the fourth quarter of fiscal 2016 and the fiscal
year ended July 31, 2016,
respectively, compared to $3.8
million and $13.1 million for
the same periods in 2015. General and administrative expenses were
$2.9 million and $12.1 million for the fourth quarter of fiscal
2016 and the fiscal year ended July 31,
2016, compared to $2.7 million
and $8.1 million for the same period
in 2015.
At July 31, 2016, OncoSec had
$28.7 million in cash and cash
equivalents, as compared to $32.0
million of cash and cash equivalents at July 31, 2015. OncoSec expects these funds to be
sufficient to allow it to continue to operate its business for at
least the next 12 months.
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 the
potential to initiate 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 "expects," "designed
to," "potential," 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 our ability to raise additional funding necessary
to fund continued operations; delays and other 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; our ability to recruit and retain qualified
personnel; unexpected new data, safety and technical issues; 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
Balance
Sheets
|
|
|
|
July 31,
2016
|
|
July 31,
2015
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
28,746,224
|
|
$
|
32,035,264
|
|
|
Prepaid
expenses
|
|
656,434
|
|
1,511,587
|
|
|
Other current
assets
|
|
14,750
|
|
21,130
|
|
|
Total Current
Assets
|
|
29,417,408
|
|
33,567,981
|
|
|
Property and
equipment, net
|
|
2,799,930
|
|
1,807,982
|
|
|
Other long-term
assets
|
|
189,309
|
|
214,127
|
|
|
Total
Assets
|
|
$
|
32,406,647
|
|
$
|
35,590,090
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
3,223,327
|
|
$
|
2,360,505
|
|
|
Accrued compensation
related
|
|
242,924
|
|
501,446
|
|
|
Total Current
Liabilities
|
|
3,466,251
|
|
2,861,951
|
|
|
Other long-term
liabilities
|
|
887,292
|
|
32,518
|
|
|
Total
Liabilities
|
|
4,353,543
|
|
2,894,469
|
|
|
|
|
|
|
|
|
Commitments and
Contingencies (Note 9)
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
|
|
|
Common stock
authorized - 160,000,000 common shares with a par value of
$0.0001, common stock issued and outstanding — 18,036,263 and
14,820,854 common shares as of July 31, 2016
and July 31, 2015, respectively (1)
|
|
25,269
|
|
24,947
|
|
|
Additional paid-in
capital
|
|
88,233,965
|
|
71,572,714
|
|
|
Warrants issued and
outstanding — 12,859,286 and 1,895,102 warrants as of
July 31, 2016 and July 31, 2015,
respectively (1)
|
|
13,288,527
|
|
7,704,103
|
|
|
Accumulated
deficit
|
|
(73,494,657)
|
|
(46,606,143)
|
|
|
Total Stockholders'
Equity
|
|
28,053,104
|
|
32,695,621
|
|
|
Total Liabilities and
Stockholders' Equity
|
|
$
|
32,406,647
|
|
$
|
35,590,090
|
|
|
|
___________________________
|
|
(1) Effective May 18,
2015, the Company implemented a reverse stock split pursuant to
which each 20 shares of issued and outstanding common stock held by
each stockholder were combined into and became one share of common
stock, with such resulting shares rounded up to the next whole
share. No fractional shares were issued. All options,
warrants and other convertible securities outstanding immediately
prior to the reverse split were adjusted by dividing the number of
shares of common stock into which the options, warrants and other
convertible securities are exercisable or convertible by 20 and
multiplying the exercise or conversion price by 20, all in
accordance with the terms of the agreements governing such options,
warrants and other convertible securities. The
accompanying financial statement data for the annual prior periods
presented have been retroactively adjusted to reflect the effects
of the reverse stock split.
|
|
OncoSec Medical
Incorporated
Statements of
Operations
|
|
|
|
|
|
|
|
|
Year Ended
|
|
Year Ended
|
|
|
|
July 31, 2016
|
|
July 31, 2015
|
|
|
Revenue
|
|
$
|
—
|
|
$
|
—
|
|
|
Expenses:
|
|
|
|
|
|
|
Research and
development
|
|
14,741,694
|
|
13,132,898
|
|
|
General and
administrative
|
|
12,144,358
|
|
8,108,244
|
|
|
Loss from
operations
|
|
(26,886,052)
|
|
(21,241,142)
|
|
|
Provision for income
taxes
|
|
2,462
|
|
1,969
|
|
|
Net loss
|
|
$
|
(26,888,514)
|
|
$
|
(21,243,111)
|
|
|
Basic and diluted net
loss per common share (1)
|
|
$
|
(1.63)
|
|
$
|
(1.67)
|
|
|
Weighted average
shares used in computing basic and diluted net
loss per common share (1)
|
|
16,514,737
|
|
12,708,974
|
|
|
|
___________________________
|
|
(1) Effective May 18,
2015, the Company implemented a reverse stock split pursuant to
which each 20 shares of issued and outstanding common stock held by
each stockholder were combined into and became one share of common
stock, with such resulting shares rounded up to the next whole
share. No fractional shares were issued. All options,
warrants and other convertible securities outstanding immediately
prior to the reverse split were adjusted by dividing the number of
shares of common stock into which the options, warrants and other
convertible securities are exercisable or convertible by 20 and
multiplying the exercise or conversion price by 20, all in
accordance with the terms of the agreements governing such options,
warrants and other convertible securities. The
accompanying financial statement data for the annual prior periods
presented have been retroactively adjusted to reflect the effects
of the reverse stock split.
|
|
OncoSec Medical
Incorporated
Statements of Cash
Flows
|
|
|
|
Year Ended
|
|
Year Ended
|
|
|
|
July 31, 2016
|
|
July 31, 2015
|
|
|
Operating
activities
|
|
|
|
|
|
|
Net loss
|
|
$
|
(26,888,514)
|
|
$
|
(21,243,111)
|
|
|
Adjustments to
reconcile net loss to net cash used in
operating activities:
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
355,583
|
|
664,596
|
|
|
Stock-based
compensation
|
|
6,116,660
|
|
2,547,729
|
|
|
Stock-based
compensation related to stock issuance liability in connection
with a contractual agreement
|
|
—
|
|
55,500
|
|
|
Common stock issued
for services
|
|
55,387
|
|
57,750
|
|
|
Loss on disposal of
property and equipment
|
|
203,196
|
|
4,325
|
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
(Increase) decrease in
prepaid expenses
|
|
855,152
|
|
(1,068,699)
|
|
|
(Increase) decrease in
other current
|
|
6,380
|
|
2,465
|
|
|
(Increase) decrease in
other long-term assets
|
|
24,818
|
|
(187,442)
|
|
|
(Decrease) increase in
accounts payable and accrued liabilities
|
|
861,634
|
|
1,068,652
|
|
|
(Decrease) increase in
accrued compensation
|
|
(258,522)
|
|
459,592
|
|
|
(Decrease) increase in
other long-term liabilities
|
|
854,773
|
|
(12,027)
|
|
|
(Decrease) Increase in
accrued income taxes
|
|
(800)
|
|
(800)
|
|
|
Net cash used in
operating activities
|
|
(17,814,253)
|
|
(17,651,470)
|
|
|
Investing
activities
|
|
|
|
|
|
|
Purchases of property
and equipment
|
|
(1,470,635)
|
|
(1,412,217)
|
|
|
Leasehold
improvements
|
|
(80,102)
|
|
(18,938)
|
|
|
Net cash used in
investing activities
|
|
(1,550,737)
|
|
(1,431,155)
|
|
|
Financing
activities
|
|
|
|
|
|
|
Proceeds from issuance
of common stock and warrants
|
|
17,451,565
|
|
13,580,001
|
|
|
Payment of financing
and offering costs
|
|
(1,381,615)
|
|
(1,091,794)
|
|
|
Proceeds from exercise
of warrants and stock options
|
|
6,000
|
|
776,988
|
|
|
Net cash provided by
financing activities
|
|
16,075,950
|
|
13,265,195
|
|
|
Net increase
(decrease) in cash
|
|
(3,289,040)
|
|
(5,817,430)
|
|
|
Cash and cash
equivalents, at beginning of year
|
|
32,035,264
|
|
37,852,694
|
|
|
Cash and cash
equivalents, at end of year
|
|
$
|
28,746,224
|
|
$
|
32,035,264
|
|
|
|
|
|
|
|
|
Supplemental
disclosure for cash flow information:
|
|
|
|
|
|
|
Cash paid during the
period for:
|
|
|
|
|
|
|
Interest
|
|
$
|
—
|
|
$
|
—
|
|
|
Income
taxes
|
|
$
|
2,462
|
|
$
|
1,969
|
|
|
|
|
|
|
|
|
Noncash investing and
financing transaction:
|
|
|
|
|
|
|
Fair value of
placement agent warrants issued in the
public offerings
|
|
$
|
536,909
|
|
$
|
571,868
|
|
|
Noncash expiration of
March 2011 and June 2011 warrants
|
|
$
|
963,356
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
Contact
Investor Relations:
Sophia Ononye, PhD MPH MBA
OncoSec Medical Incorporated
855-662-6732
investors@oncosec.com
Media Relations:
Sophia Ononye, PhD MPH MBA
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com
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SOURCE OncoSec Medical Incorporated