PR Newswire
SAN DIEGO, June 1, 2017
SAN DIEGO, June 1, 2017 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced third quarter and year-to-date financial results ended April 30, 2017.
"We have made significant progress this past quarter in advancing our clinical and regulatory pathway for ImmunoPulse® IL-12, which we believe can provide a meaningful clinical benefit to patients with limited or no treatment options," said Punit Dhillon, President and CEO of OncoSec. "With a clinical collaboration and drug supply agreement for pembrolizumab and FDA Fast Track designation in hand, we are working diligently on the site start-up and initiation activities related to our registration-directed study, which we call PISCES. By pursuing an accelerated pathway, this puts us in a favorable position to secure the first approval in the anti-PD-1 non-responder patient population in advanced melanoma."
Third Quarter and YTD 2017 Financial Results
Third Quarter 2017 and Recent Highlights
ImmunoPulse® IL-12 Progress
Strategic Collaborations
R&D and Pipeline Expansion
2017 Development Milestones
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 | ||||
(unaudited) |
||||
April 30, |
July 31, | |||
2017 |
2016 | |||
Assets |
||||
Current assets |
||||
Cash and cash equivalents |
$ |
16,106,338 |
$ |
28,746,224 |
Prepaid expenses and other current assets |
987,160 |
671,184 | ||
Total Current Assets |
17,093,498 |
29,417,408 | ||
Property and equipment, net |
2,493,784 |
2,799,930 | ||
Other long-term assets |
384,256 |
189,309 | ||
Total Assets |
$ |
19,971,538 |
$ |
32,406,647 |
Liabilities and Stockholders' Equity |
||||
Liabilities |
||||
Current liabilities |
||||
Accounts payable and accrued liabilities |
$ |
2,644,259 |
$ |
3,223,327 |
Accrued compensation |
168,234 |
242,924 | ||
Total Current Liabilities |
2,812,493 |
3,466,251 | ||
Other long-term liabilities |
1,196,716 |
887,292 | ||
Total Liabilities |
4,009,209 |
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 — 21,168,194 and 18,036,263 common shares as of April 30, 2017 and July 31, 2016, respectively |
25,582 |
25,269 | ||
Additional paid-in capital |
93,195,870 |
88,233,965 | ||
Warrants issued and outstanding — 9,494,740 and 12,859,286 warrants as of April 30, 2017 and July 31, 2016, respectively |
11,780,307 |
13,288,527 | ||
Accumulated other comprehensive income |
7,094 |
- | ||
Accumulated deficit |
(89,046,524) |
(73,494,657) | ||
Total Stockholders' Equity |
15,962,329 |
28,053,104 | ||
Total Liabilities and Stockholders' Equity |
$ |
19,971,538 |
$ |
32,406,647 |
OncoSec Medical Incorporated | ||||||||
Three Months Ended |
Nine Months Ended | |||||||
April 30, 2017 |
April 30, 2016 |
April 30, 2017 |
April 30, 2016 | |||||
Revenue |
$ |
- |
$ |
- |
$ |
- |
$ |
- |
Expenses: |
||||||||
Research and development |
2,656,073 |
3,376,757 |
8,638,423 |
11,149,652 | ||||
General and administrative |
1,904,899 |
2,874,362 |
6,912,053 |
9,174,406 | ||||
Loss before income taxes |
(4,560,972) |
(6,251,119) |
(15,550,476) |
(20,324,058) | ||||
Provision for income taxes |
- |
290 |
1,391 |
2,462 | ||||
Net loss |
$ |
(4,560,972) |
$ |
(6,251,409) |
$ |
(15,551,867) |
$ |
(20,326,520) |
Basic and diluted net loss per common share |
$ |
(0.22) |
$ |
(0.37) |
$ |
(0.79) |
$ |
(1.27) |
Weighted average shares used in computing basic and diluted net loss per common share |
20,704,393 |
16,971,214 |
19,809,739 |
15,955,116 |
OncoSec Medical Incorporated | |||||
Three Months Ended |
Nine Months Ended | ||||
April 30, 2017 |
April 30, 2016 |
April 30, 2017 |
April 30, 2016 | ||
Net Loss |
$ (4,560,972) |
$ (6,251,409) |
$ (15,551,867) |
$ (20,326,520) | |
Foreign currency translation adjustments |
7,080 |
- |
7,094 |
- | |
Comprehensive Loss |
$ (4,553,892) |
$ (6,251,409) |
$ (15,544,773) |
$ (20,326,520) |
OncoSec Medical Incorporated | ||||
Nine Months Ended | ||||
April 30, 2017 |
April 30, 2016 | |||
Operating activities |
||||
Net loss |
$ |
(15,551,867) |
$ |
(20,326,520) |
Adjustments to reconcile net loss to net cash used in operating |
||||
Depreciation and amortization |
284,319 |
253,664 | ||
Loss on disposal of property and equipment |
- |
41,989 | ||
Stock-based compensation |
3,378,991 |
4,676,215 | ||
Changes in operating assets and liabilities: |
||||
Decrease(Increase) in prepaid expenses and other current assets |
(315,976) |
532,214 | ||
Decrease(Increase) in other long-term assets |
(163,542) |
25,286 | ||
Decrease(Increase) in accounts payable and accrued liabilities |
(579,068) |
461,617 | ||
Increase (decrease) in accrued compensation |
(74,690) |
15,724 | ||
Increase in other long-term liabilities |
309,424 |
573,654 | ||
Net cash used in operating activities |
(12,712,409) |
(13,746,157) | ||
Investing activities |
||||
Purchases of property and equipment |
(9,578) |
(1,156,420) | ||
Net cash used in investing activities |
(9,578) |
(1,156,420) | ||
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 |
30,950 |
- | ||
Proceeds from issuance of common stock |
44,057 |
- | ||
Net cash provided by financing activities |
75,007 |
6,886,095 | ||
Effect of exchange rate changes on cash |
7,094 |
- | ||
Net (decrease) in cash |
(12,639,886) |
(8,016,482) | ||
Cash and cash equivalents, at beginning of period |
28,746,224 |
32,035,264 | ||
Cash and cash equivalents, at end of period |
$ |
16,106,338 |
$ |
24,018,782 |
Supplemental disclosure for cash flow information: |
||||
Cash paid during the period for: |
||||
Interest |
$ |
- |
$ |
- |
Income taxes |
$ |
1,391 |
$ |
2,462 |
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 |
$ |
- |
$ |
55,500 |
Noncash expiration of warrants |
$ |
1,479,274 |
$ |
431,981 |
R&D Equipment in use but financed through accounts payable and accrued liabilities |
$ |
- |
$ |
393,718 |
CONTACTS:
Investor Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
[email protected]
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/oncosec-announces-third-quarter-and-ytd-results-for-fiscal-year-2017-300467453.html
SOURCE OncoSec Medical Incorporated
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