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| 8-K - ONCOSEC MEDICAL Inc | form8-k.htm |
OncoSec Announces Second Quarter and YTD Results for Fiscal Year 2017
SAN DIEGO – March 16, 2017 — 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