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