SAN DIEGO, Oct. 14, 2015 /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, 2015.
"We made significant progress in fiscal year 2015, including the
addition of several key employees, meeting important clinical
milestones, and continued strengthening of our balance sheet," said
Punit Dhillon, President and CEO of
OncoSec. "Immuno-oncology continues to give rise to groundbreaking
new treatments and is shifting the cancer treatment paradigm. I am
very excited about the prospects for OncoSec as we develop
therapies that aim to harness the immune system to fight cancer and
address a great unmet medical need in oncology: anti-PD-1
non-responders. OncoSec's talented and professional team has the
experience, insight, and resources to advance our R&D and
clinical efforts to capture the value in this opportunity."
FINANCIAL RESULTS
For the fourth quarter of fiscal
2015 and the fiscal year ended July 31,
2015, OncoSec reported a net loss of $6.5 million and $21.2
million, or $0.48 per share
and $1.67 per share, respectively,
compared to a net loss of $3.6
million and $12.0 million, or
$0.30 per share and $1.26 per share, respectively, for the same
period last year. The increase in net loss for the year ended
July 31, 2015, compared with the same
period in 2014, resulted primarily from (i) an increase in
headcount as OncoSec continues to grow its discovery research and
clinical teams, (ii) additional outside services costs to support
its device development and clinical activities and (iii) corporate
communication, financing and other administrative investments to
expand investor awareness and list the Company on The Nasdaq Stock
Market. There were no revenues for the fiscal years ended
July 31, 2015 or July 31, 2014.
Research and development expenses were $3.8 million and $13.1
million for the fourth quarter of fiscal 2015 and the fiscal
year ended July 31, 2015,
respectively, compared to $1.9
million and $5.8 million for
the same periods in 2014. General and administrative expenses were
$2.7 million and $8.1 million for the fourth quarter of fiscal
2015 and the fiscal year ended July 31,
2015, compared to $1.7 million
and $6.2 million for the same period
in 2014.
At July 31, 2015, OncoSec had
$32.0 million in cash and cash
equivalents, as compared to $37.9
million of cash and cash equivalents at July 31, 2014. 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 for the treatment of cancer. The Company's
investigational technology, ImmunoPulse™, is designed to enhance
the local delivery and uptake of DNA-based immune-targeting agents,
such as interleukin-12 (IL-12). In Phase I and II clinical trials,
OncoSec's lead program, ImmunoPulse™ IL-12, demonstrated a
favorable safety profile and evidence of anti-tumor activity in the
treatment of various skin cancers as well as the potential to
initiate a systemic immune response. ImmunoPulse™ IL-12 is
currently in Phase II development for several indications,
including metastatic melanoma, squamous cell carcinoma of the head
and neck, and triple-negative breast cancer. In addition to
ImmunoPulse™ IL-12, the Company is also seeking to identify and
develop 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 regarding future events and the future performance of
OncoSec. Forward-looking statements are subject to risks and
uncertainties, which may cause actual results to differ materially
from current expectations. These risks and uncertainties
include, among others, the following: our ability to raise
additional funding necessary to fund continued operations on
reasonable terms or at all; our ability to protect our intellectual
property; 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; delays in the
commencement or completion of clinical testing for product
candidates; unexpected new data, safety and technical issues; our
ability to develop and commercialize the assets we have acquired or
develop and any new assets and product candidates; and
competitive, market and regulatory conditions. Other risks and
uncertainties are described in OncoSec's annual report on Form 10-K
filed on October 10, 2014, and
subsequent filings with the U.S. Securities and Exchange Commission
made by OncoSec. Except as required by law, OncoSec undertakes no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
|
OncoSec Medical
Incorporated
|
|
Balance Sheet and
Consolidated Balance Sheet
|
|
|
|
July 31,
2015
|
|
July 31,
2014
|
|
Assets
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
32,035,264
|
|
$
|
37,852,694
|
|
Prepaid
expenses
|
|
1,511,587
|
|
442,888
|
|
Other current
assets
|
|
21,130
|
|
23,595
|
|
Total Current
Assets
|
|
33,567,981
|
|
38,319,177
|
|
Property and
equipment, net
|
|
1,807,982
|
|
581,054
|
|
Intangible assets,
net
|
|
—
|
|
464,693
|
|
Other long-term
assets
|
|
214,127
|
|
26,685
|
|
Total
Assets
|
|
$
|
35,590,090
|
|
$
|
39,391,609
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
2,360,505
|
|
$
|
1,236,352
|
|
Accrued compensation
related
|
|
501,446
|
|
42,654
|
|
Accrued income
taxes
|
|
—
|
|
800
|
|
Accrued
other
|
|
32,518
|
|
43,745
|
|
Total
Liabilities
|
|
2,894,469
|
|
1,323,551
|
|
|
|
|
|
|
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 - 14,820,854
and 12,233,203 common shares as of July 31,
2015 and July 31, 2014, respectively (1)
|
|
24,947
|
|
24,463
|
|
Additional paid-in
capital
|
|
71,572,714
|
|
56,081,475
|
|
Warrants issued and
outstanding — 1,895,102 and 1,882,399 warrants as of
July 31, 2015 and July 31, 2014, respectively
(1)
|
|
7,704,103
|
|
7,325,152
|
|
Accumulated
deficit
|
|
(46,606,143)
|
|
(25,363,032)
|
|
Total Stockholders'
Equity
|
|
32,695,621
|
|
38,068,058
|
|
Total Liabilities and
Stockholders' Equity
|
|
$
|
35,590,090
|
|
$
|
39,391,609
|
|
|
|
|
(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
|
|
Statement of
Operations and Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
Year Ended
|
|
Year Ended
|
|
|
July 31, 2015
|
|
July 31, 2014
|
|
July 31, 2013
|
|
Revenue
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
Expenses:
|
|
|
|
|
|
|
|
Research and
development
|
|
13,132,898
|
|
5,796,347
|
|
3,159,209
|
|
General and
administrative
|
|
8,108,244
|
|
6,153,313
|
|
3,905,763
|
|
Loss from
operations
|
|
(21,241,142)
|
|
(11,949,660)
|
|
(7,064,972)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Non-cash interest
expense
|
|
—
|
|
(20,684)
|
|
(83,215)
|
|
Net loss before
income taxes
|
|
(21,241,142)
|
|
(11,970,344)
|
|
(7,148,187)
|
|
Provision for income
taxes
|
|
1,969
|
|
41,773
|
|
2,000
|
|
Net loss, net of
tax
|
|
$
|
(21,243,111)
|
|
$
|
(12,012,117)
|
|
$
|
(7,150,187)
|
|
Basic and diluted net
loss per common share (1)
|
|
$
|
(1.67)
|
|
$
|
(1.26)
|
|
$
|
(1.34)
|
|
Weighted average
shares used in computing basic and diluted net loss
per common share (1)
|
|
12,708,974
|
|
9,527,182
|
|
5,327,917
|
|
|
|
|
(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
|
|
Statement of Cash
Flows and Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
Year Ended
|
|
Year Ended
|
|
|
July 31, 2015
|
|
July 31, 2014
|
|
July 31, 2013
|
|
Operating
activities
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(21,243,111)
|
|
$
|
(12,012,117)
|
|
$
|
(7,150,187)
|
|
Adjustments to
reconcile net loss to net cash used in
operating activities:
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
664,596
|
|
780,110
|
|
736,875
|
|
Non-cash interest
expense
|
|
—
|
|
20,684
|
|
83,215
|
|
Stock-based
compensation
|
|
2,547,729
|
|
1,815,559
|
|
452,128
|
|
Stock-based
compensation related to stock issuance liability in connection with
a contractual agreement
|
|
55,500
|
|
—
|
|
—
|
|
Common stock issued
for services
|
|
57,750
|
|
150,000
|
|
34,500
|
|
Loss on sale of fixed assets
|
|
4,325
|
|
—
|
|
—
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
(Increase) decrease in
prepaid expenses
|
|
(1,068,699)
|
|
(405,904)
|
|
156,194
|
|
(Increase) decrease
in other current
|
|
2,465
|
|
(11,067)
|
|
(30,845)
|
|
(Increase) decrease
in other long-term assets
|
|
(187,442)
|
|
—
|
|
—
|
|
(Decrease) increase in
accounts payable and accrued liabilities
|
|
1,068,652
|
|
657,266
|
|
344,764
|
|
(Decrease) increase in
accrued compensation
|
|
459,592
|
|
42,654
|
|
(218,849)
|
|
(Decrease) increase in
accrued other
|
|
(12,027)
|
|
(16,858)
|
|
60,603
|
|
(Decrease) Increase in
accrued income taxes
|
|
(800)
|
|
(800)
|
|
(1,600)
|
|
Net cash used in
operating activities
|
|
(17,651,470)
|
|
(8,980,473)
|
|
(5,533,202)
|
|
Investing
activities
|
|
|
|
|
|
|
|
Purchases of property
and equipment
|
|
(1,412,217)
|
|
(512,500)
|
|
(114,550)
|
|
Leasehold
improvements
|
|
(18,938)
|
|
—
|
|
—
|
|
Net cash used in
investing activities
|
|
(1,431,155)
|
|
(512,500)
|
|
(114,550)
|
|
Financing
activities
|
|
|
|
|
|
|
|
Proceeds from
issuance of common stock and warrants
|
|
13,580,001
|
|
27,948,001
|
|
7,200,000
|
|
Payment of financing
and offering costs
|
|
(1,091,794)
|
|
(1,981,360)
|
|
(504,000)
|
|
Payment of amounts due
under acquisition obligation
|
|
—
|
|
(1,000,000)
|
|
(1,500,000)
|
|
Proceeds from exercise
of warrants and stock options
|
|
776,988
|
|
17,408,851
|
|
280,418
|
|
Net cash provided by
financing activities
|
|
13,265,195
|
|
42,375,492
|
|
5,476,418
|
|
Net increase
(decrease) in cash
|
|
(5,817,430)
|
|
32,882,519
|
|
(171,334)
|
|
Cash and cash
equivalents, at beginning of period
|
|
37,852,694
|
|
4,970,175
|
|
5,141,509
|
|
Cash and cash
equivalents, at end of period
|
|
$
|
32,035,264
|
|
$
|
37,852,694
|
|
$
|
4,970,175
|
|
|
|
|
|
|
|
|
Supplemental
disclosure for cash flow information:
|
|
|
|
|
|
|
|
Cash paid during the
period for:
|
|
|
|
|
|
|
|
Interest
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
Income
taxes
|
|
$
|
1,969
|
|
$
|
1,600
|
|
$
|
2,800
|
|
|
|
|
|
|
|
|
Noncash investing and
financing transaction:
|
|
|
|
|
|
|
|
Fair value of
placement agent warrants issued in the
public offerings
|
|
$
|
571,868
|
|
$
|
1,042,242
|
|
$
|
228,240
|
Contact
Investor Relations:
Jordyn Kopin
OncoSec Medical Incorporated
855-662-6732
investors@oncosec.com
Media Relations:
Mary Marolla
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com
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SOURCE OncoSec Medical Incorporated