SAN DIEGO, March 16, 2017 /PRNewswire/ -- OncoSec Medical
Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing
DNA-based intratumoral cancer immunotherapies, today announced
financial results for the second quarter and year to date ended
January 31, 2017.
"As we enter the next quarter, we are confident in our clinical
and regulatory pathway for the development of our lead candidate,
ImmunoPulse® IL-12, which we believe holds the greatest potential
for patients who are anti-PD-1 non-responders," said Punit Dhillon, President and CEO of OncoSec.
"Since we've secured Fast Track designation, our main objectives
are focused on initiating the Phase IIb registration-directed trial
in Stage III/IV melanoma anti-PD-1 non-responder population and
finalizing a drug supply agreement for this trial."
FINANCIAL RESULTS
For the second quarter of fiscal
2017 and the six months ended January 31,
2017, OncoSec reported a net loss of $5.4 million and $11.0
million, or $0.27 per share
and $0.57 per share, respectively,
compared to a net loss of $7.0
million and $14.1 million, or
$0.42 per share and $0.89 per share, respectively, for the same
periods last year. The decrease in net loss for the second quarter
ended January 31, 2017, compared with
the same period in 2016, resulted primarily from (i) a decrease in
research and development expenses, mainly $1.2 million related to clinical trial costs that
were lower 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 $0.4 million related to lower salary and non-cash
stock compensation costs. The decrease in net loss for the six
months ended January 31, 2017,
compared with the same period in 2016, resulted primarily from (i)
a decrease in research and development expenses, mainly
$1.8 million related to clinical
trial costs and outside services that were lower due to a lower
number of patient enrollments in a smaller number of actively
enrolling trials as well as lower trial management costs; (ii) a
decrease of $1.1 million related to
lower salary and non-cash stock compensation costs; and, (iii) a
decrease of $0.2 million related to
lower accounting fees. There were no revenues for the three and six
months ended January 31, 2017 or
January 31, 2016.
Research and development expenses were $2.9 million and $6.0
million for the second quarter of fiscal 2016 and the six
months ended January 31, 2017,
respectively, compared to $4.1
million and $7.8 million for
the same periods in 2016. General and administrative expenses were
$2.5 million and $5.0 million for the second quarter of fiscal
2017 and the six months ended January 31,
2017, compared to $2.9 million
and $6.3 million for the same period
in 2016.
At January 31, 2017, OncoSec had
$20.5 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 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 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
|
|
|
|
January 31,
2017
|
|
|
July 31,
2016
|
|
|
(unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
20,541,455
|
|
|
$
|
28,746,224
|
|
Prepaid expenses and
other current assets
|
|
|
793,612
|
|
|
|
671,184
|
|
Total Current
Assets
|
|
|
21,335,067
|
|
|
|
29,417,408
|
|
Property and
equipment, net
|
|
|
2,589,063
|
|
|
|
2,799,930
|
|
Other long-term
assets
|
|
|
383,780
|
|
|
|
189,309
|
|
Total
Assets
|
|
$
|
24,307,910
|
|
|
$
|
32,406,647
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
3,296,824
|
|
|
$
|
3,223,327
|
|
Accrued
compensation
|
|
|
116,930
|
|
|
|
242,924
|
|
Total Current
Liabilities
|
|
|
3,413,754
|
|
|
|
3,466,251
|
|
Other long-term
liabilities
|
|
|
1,193,230
|
|
|
|
887,292
|
|
Total
Liabilities
|
|
|
4,606,984
|
|
|
|
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 —
19,734,645 and 18,036,263 common shares as of
January 31, 2017
and July 31, 2016, respectively
|
|
|
25,439
|
|
|
|
25,269
|
|
Additional paid-in
capital
|
|
|
91,196,781
|
|
|
|
88,233,965
|
|
Warrants issued and
outstanding — 11,286,995 and 12,859,286
warrants as of January 31, 2017 and July 31, 2016,
respectively
|
|
|
12,964,244
|
|
|
|
13,288,527
|
|
Accumulated other
comprehensive income
|
|
|
14
|
|
|
|
-
|
|
Accumulated
deficit
|
|
|
(84,485,552)
|
|
|
|
(73,494,657)
|
|
Total Stockholders'
Equity
|
|
|
19,700,926
|
|
|
|
28,053,104
|
|
Total Liabilities and
Stockholders' Equity
|
|
$
|
24,307,910
|
|
|
$
|
32,406,647
|
|
|
The notes are an
integral part of these condensed consolidated financial
statements.
|
|
OncoSec Medical
Incorporated
|
|
Condensed
Consolidated Statements of Operations and Condensed Statements of
Operations (unaudited)
|
|
|
|
Three Months
Ended
|
|
|
Six Months
Ended
|
|
|
January 31,
2017
|
|
|
January 31,
2016
|
|
|
January 31,
2017
|
|
|
January 31,
2016
|
|
Revenue
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
2,882,611
|
|
|
|
4,113,582
|
|
|
|
5,982,351
|
|
|
|
7,772,895
|
|
General and
administrative
|
|
|
2,504,700
|
|
|
|
2,924,138
|
|
|
|
5,007,152
|
|
|
|
6,300,044
|
|
Loss before income
taxes
|
|
|
(5,387,311)
|
|
|
|
(7,037,720)
|
|
|
|
(10,989,503)
|
|
|
|
(14,072,939)
|
|
Provision for income
taxes
|
|
|
-
|
|
|
|
-
|
|
|
|
1,391
|
|
|
|
2,172
|
|
Net loss
|
|
$
|
(5,387,311)
|
|
|
$
|
(7,037,720)
|
|
|
$
|
(10,990,894)
|
|
|
$
|
(14,075,111)
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.27)
|
|
|
$
|
(0.42)
|
|
|
$
|
(0.57)
|
|
|
$
|
(0.89)
|
|
Weighted average
shares used in computing basic and diluted net loss per common
share
|
|
|
19,733,015
|
|
|
|
16,761,586
|
|
|
|
19,376,998
|
|
|
|
15,794,970
|
|
|
The notes are
an integral part of these condensed consolidated financial
statements.
|
|
OncoSec Medical
Incorporated
|
|
Condensed
Consolidated Statements of Comprehensive Loss and Condensed
Statements of Comprehensive Loss (unaudited)
|
|
|
|
Three Months
Ended
|
|
|
Six Months
Ended
|
|
|
January 31,
2017
|
|
|
January 31,
2016
|
|
|
January 31,
2017
|
|
|
January 31,
2016
|
|
Net Loss
|
|
$
|
(5,387,311)
|
|
|
$
|
(7,037,720)
|
|
|
$
|
(10,990,894)
|
|
|
$
|
(14,075,111)
|
|
Foreign currency
translation adjustments
|
|
|
23
|
|
|
|
-
|
|
|
|
14
|
|
|
|
-
|
|
Comprehensive
Loss
|
|
$
|
(5,387,288)
|
|
|
$
|
(7,037,720)
|
|
|
$
|
(10,990,880)
|
|
|
$
|
(14,075,111)
|
|
|
The notes are
an integral part of these condensed consolidated financial
statements.
|
|
OncoSec Medical
Incorporated
|
|
Condensed
Consolidated Statement of Cash Flows and Condensed Statement of
Cash Flows (unaudited)
|
|
|
|
Six Months
Ended
|
|
|
January 31,
2017
|
|
|
January 31,
2016
|
|
Operating
activities
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(10,990,894)
|
|
|
$
|
(14,075,111)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
189,039
|
|
|
|
151,601
|
|
Loss on disposal of
property and equipment
|
|
|
-
|
|
|
|
41,989
|
|
Stock-based
compensation
|
|
|
2,596,280
|
|
|
|
3,030,225
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
(Increase) in prepaid
expenses and other current assets
|
|
|
(122,428)
|
|
|
|
313,499
|
|
(Increase) in other
long-term assets
|
|
|
(163,064)
|
|
|
|
25,751
|
|
Increase in accounts
payable and accrued liabilities
|
|
|
73,497
|
|
|
|
1,100,097
|
|
Increase (decrease)
in accrued compensation
|
|
|
(125,994)
|
|
|
|
104,237
|
|
Increase in other
long-term liabilities
|
|
|
305,936
|
|
|
|
292,534
|
|
Net cash used in
operating activities
|
|
|
(8,235,628)
|
|
|
|
(9,015,178)
|
|
Investing
activities
|
|
|
|
|
|
|
|
|
Purchases of property
and equipment
|
|
|
(9,578)
|
|
|
|
(1,060,910)
|
|
Net cash used in
investing activities
|
|
|
(9,578)
|
|
|
|
(1,060,910)
|
|
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 (Sabby)
|
|
|
16,808
|
|
|
|
-
|
|
Proceeds from
issuance of common stock (ESPP)
|
|
|
25,615
|
|
|
|
-
|
|
Net cash provided by
financing activities
|
|
|
42,423
|
|
|
|
6,886,095
|
|
Effect of exchange
rate changes on cash
|
|
|
14
|
|
|
|
-
|
|
Net (decrease) in
cash
|
|
|
(8,204,769)
|
|
|
|
(3,189,993)
|
|
Cash and cash
equivalents, at beginning of period
|
|
|
28,746,224
|
|
|
|
32,035,264
|
|
Cash and cash
equivalents, at end of period
|
|
$
|
20,541,455
|
|
|
$
|
28,845,271
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure for cash flow information:
|
|
|
|
|
|
|
|
|
Cash paid during the
period for:
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
-
|
|
|
$
|
-
|
|
Income
taxes
|
|
$
|
1,391
|
|
|
$
|
2,172
|
|
|
|
|
|
|
|
|
|
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
|
|
|
309,477
|
|
|
|
-
|
|
|
|
The notes
are an integral part of these condensed consolidated financial
statements
|
CONTACTS:
Investor Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
investors@oncosec.com
Media:
Laura Radocaj
DGI Comm
Phone: 212-825-3210
media@oncosec.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/oncosec-announces-second-quarter-and-ytd-results-for-fiscal-year-2017-300424959.html
SOURCE OncoSec Medical Incorporated