SAN DIEGO, Dec. 8, 2016 /PRNewswire/ -- OncoSec Medical
Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing
DNA-based intratumoral cancer immunotherapies, today announced
financial results for the fiscal first quarter 2017.
"We are delivering on our commitment to address an unmet medical
need in melanoma with ImmunoPulse® IL-12. We are pleased with the
early clinical response data presented from the melanoma
combination trial, and we are focused on advancing our lead program
– ImmunoPulse® IL-12 – in anti-PD-1 non-responder advanced melanoma
patients. Based on our current cash runway, we are positioned to
meet our value-driving clinical and regulatory milestones into
calendar 2018 and have a clear strategy to expand our therapeutic
platform," noted Punit Dhillon,
OncoSec President and Chief Executive Officer. "Our primary focus
for the next year is to initiate a melanoma registration-directed
clinical study. We believe we will generate meaningful data in 2017
and 2018 to support the discussions with the FDA and a future
biologics license application (BLA) to attract a partner, who is
ready to advance this innovative therapy."
FINANCIAL RESULTS
For the first quarter of fiscal
2017, OncoSec reported a net loss of $5.6
million or $0.29 per share,
compared to a net loss of $7.0
million, or $0.47 per share
for the same period last year. The decrease in net loss for the
quarter ended October 31, 2016,
compared with the same period in fiscal 2016, resulted primarily
from (i) the completion of the melanoma monotherapy extension
clinical trial, (ii) decreased engineering and lab supplies costs
due to the completion of next-generation electroporation
prototypes, (iii) decreased outside service fees due to leveraging
in-house capabilities, and (iv) decreased stock-based compensation
expense. There were no revenues for the quarter ended October 31, 2016 or October 31, 2015.
Research and development expenses were $3.1 million for the first quarter of fiscal
2017, compared to $3.7 million for
the same period in fiscal 2016. General and administrative expenses
were $2.5 million for the first
quarter of fiscal 2017, compared to $3.4
million for the same period in fiscal 2016.
At October 31, 2016, OncoSec had
$24.4 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 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
|
|
Condensed
Consolidated Balance Sheet and Condensed Balance
Sheet
|
|
|
|
October 31,
2016
|
|
|
July 31,
2016
|
|
|
|
(unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
24,350,898
|
|
|
$
|
28,746,224
|
|
|
Prepaid expenses and
other current assets
|
|
|
861,070
|
|
|
|
671,184
|
|
|
Total Current
Assets
|
|
|
25,211,968
|
|
|
|
29,417,408
|
|
|
Property and
equipment, net
|
|
|
2,687,992
|
|
|
|
2,799,930
|
|
|
Other long-term
assets
|
|
|
189,785
|
|
|
|
189,309
|
|
|
Total
Assets
|
|
$
|
28,089,745
|
|
|
$
|
32,406,647
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
3,011,475
|
|
|
$
|
3,223,327
|
|
|
Accrued
compensation
|
|
|
309,463
|
|
|
|
242,924
|
|
|
Total Current
Liabilities
|
|
|
3,320,938
|
|
|
|
3,466,251
|
|
|
Other long-term
liabilities
|
|
|
1,130,166
|
|
|
|
887,292
|
|
|
Total
Liabilities
|
|
|
4,451,104
|
|
|
|
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 — 19,584,645 and 18,036,263
common shares as of October 31, 2016 and July 31, 2016,
respectively
|
|
|
25,424
|
|
|
|
25,269
|
|
|
Additional paid-in
capital
|
|
|
89,664,757
|
|
|
|
88,233,965
|
|
|
Warrants issued and
outstanding — 11,478,693 and 12,859,286 warrants as of October 31,
2016 and July 31, 2016, respectively
|
|
|
13,046,712
|
|
|
|
13,288,527
|
|
|
Accumulated other
comprehensive loss
|
|
|
(9)
|
|
|
|
—
|
|
|
Accumulated
deficit
|
|
|
(79,098,243)
|
|
|
|
(73,494,657)
|
|
|
Total Stockholders'
Equity
|
|
|
23,638,641
|
|
|
|
28,053,104
|
|
|
Total Liabilities and
Stockholders' Equity
|
|
$
|
28,089,745
|
|
|
$
|
32,406,647
|
|
|
OncoSec Medical
Incorporated
|
|
Condensed
Consolidated Statement of Operations and Condensed Statement
of
|
|
Operations
(unaudited)
|
|
|
|
Three
Months
Ended
October 31,
2016
|
|
Three
Months
Ended
October 31,
2015
|
|
|
Revenue
|
|
$
|
—
|
|
$
|
—
|
|
|
Expenses:
|
|
|
|
|
|
|
Research and
development
|
|
3,099,739
|
|
3,659,313
|
|
|
General and
administrative
|
|
2,502,455
|
|
3,375,906
|
|
|
Net loss before
income taxes
|
|
(5,602,194)
|
|
(7,035,219)
|
|
|
Provision for income
taxes
|
|
1,391
|
|
2,172
|
|
|
Net loss, net of
tax
|
|
$
|
(5,603,585)
|
|
$
|
(7,037,391)
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.29)
|
|
$
|
(0.47)
|
|
|
Weighted average
shares used in computing basic and diluted net loss
per common share
|
|
19,020,982
|
|
14,826,887
|
|
|
OncoSec Medical
Incorporated
|
|
Condensed
Consolidated Statement of Cash Flows and Condensed Statement
of
|
|
Cash Flows
(unaudited)
|
|
|
|
Three Months
Ended
October 31,
2016
|
|
|
Three Months
Ended
October 31,
2015
|
|
|
Operating
activities
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(5,603,585)
|
|
|
$
|
(7,037,391)
|
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
94,774
|
|
|
|
65,125
|
|
|
Loss on disposal of
property and equipment
|
|
|
—
|
|
|
|
572
|
|
|
Stock-based
compensation
|
|
|
1,148,209
|
|
|
|
1,562,066
|
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
|
(Increase) Decrease
in prepaid expenses and other current assets
|
|
|
(189,886)
|
|
|
|
441,669
|
|
|
(Increase) Decrease
in other long-term assets
|
|
|
(476)
|
|
|
|
26,685
|
|
|
(Decrease) Increase
in accounts payable and accrued liabilities
|
|
|
(183,121)
|
|
|
|
549,221
|
|
|
Increase in accrued
compensation
|
|
|
66,539
|
|
|
|
—
|
|
|
Increase (Decrease)
in other long-term liabilities
|
|
|
242,874
|
|
|
|
(265,735)
|
|
|
Net cash used in
operating activities
|
|
|
(4,424,662)
|
|
|
|
(4,657,788)
|
|
|
Investing
activities
|
|
|
|
|
|
|
|
|
|
Purchases of property
and equipment
|
|
|
(9,578)
|
|
|
|
(481,107)
|
|
|
Net cash used in
investing activities
|
|
|
(9,578)
|
|
|
|
(481,107)
|
|
|
Financing
activities
|
|
|
|
|
|
|
|
|
|
Proceeds from
issuance of common stock through employee stock purchase
plan
|
|
|
25,617
|
|
|
|
—
|
|
|
Proceeds from
exercise of warrants
|
|
|
13,306
|
|
|
|
—
|
|
|
Net cash provided by
financing activities
|
|
|
38,923
|
|
|
|
—
|
|
|
Effect of exchange
rate changes on cash
|
|
|
(9)
|
|
|
|
|
|
|
Net (decrease) in
cash
|
|
|
(4,395,326)
|
|
|
|
(5,138,895)
|
|
|
Cash and cash
equivalents, at beginning of period
|
|
|
28,746,224
|
|
|
|
32,035,264
|
|
|
Cash and cash
equivalents, at end of period
|
|
$
|
24,350,898
|
|
|
$
|
26,896,369
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure for cash flow information:
|
|
|
|
|
|
|
|
|
|
Cash paid during the
period for:
|
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Income
taxes
|
|
$
|
1,391
|
|
|
$
|
2,172
|
|
|
|
|
|
|
|
|
|
|
|
Noncash investing and
financing transaction:
|
|
|
|
|
|
|
|
|
|
Issuance of common
stock in connection with a contractual agreement
|
|
$
|
|
|
|
$
|
55,500
|
|
|
Noncash expiration of
warrants
|
|
$
|
228,509
|
|
|
$
|
—
|
|
|
Noncash activity
related to the issuance of warrants in-transit
|
|
$
|
2,000
|
|
|
$
|
__
|
|
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