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| 8-K - ONCOSEC MEDICAL Inc | form8-k.htm |
OncoSec Announces Third Quarter and YTD Results for Fiscal Year 2016
SAN DIEGO, June 9, 2016 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced key corporate objectives as well as financial results for the third quarter and year to date ended April 30, 2016.
“As we enter the next quarter, we are confident in our team’s mission to deliver safer and more effective intratumoral immunotherapies to provide long-term benefits for cancer patients. We believe the advancements in our technology as well as the preclinical and clinical data generated to date hold the greatest potential to provide meaningful benefit to patients and investment value to OncoSec’s shareholders,” said Punit Dhillon, President and CEO of OncoSec. “We have sufficient funds to advance our development efforts for the combination of ImmunoPulse™ IL-12 with anti-PD-1/PD-L1 in melanoma as well as our next ImmunoPulse product.”
FINANCIAL RESULTS
For the third quarter of fiscal 2016 and the nine months ended April 30, 2016, OncoSec reported a net loss of $6.3 million and $20.3 million, or $0.37 per share and $1.27 per share, respectively, compared to a net loss of $6.0 million and $14.7 million, or $0.48 per share and $1.19 per share, respectively, for the same periods last year. The increase in net loss for the three months ended April 30, 2016, compared with the same period in 2015, resulted primarily from an increase of $1.0 million in personnel costs, inclusive of non-cash stock-based compensation, offset by a decrease in engineering costs, outside services and bonuses as compared to the prior year. The increase in net loss for the nine months ended April 30, 2016, compared with the same period in 2015, resulted primarily from (i) an increase of $3.5 million in personnel costs, inclusive of non-cash stock-based compensation; and (ii) an increase of $1.2 million in patient treatment costs related to our clinical trials. There were no revenues for the three and nine months ended April 30, 2016 or April 30, 2015.
Research and development expenses were $3.4 million and $11.1 million for the third quarter of fiscal 2016 and the nine months ended April 30, 2016, respectively, compared to $3.9 million and $9.3 million for the same periods in 2015. General and administrative expenses were $2.9 million and $9.2 million for the third quarter of fiscal 2016 and the nine months ended April 30, 2016, compared to $2.1 million and $5.4 million for the same periods in 2015.
At April 30, 2016, OncoSec had $24.0 million in cash and cash equivalents, as compared to $32.0 million of cash and cash equivalents at July 31, 2015; however, OncoSec raised an additional $9.1 million in net proceeds from a registered direct offering on May 26, 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 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 clinical development for several indications, including metastatic melanoma 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” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as “potential,” “will,” “expect,” “believe,” 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 Balance Sheets
April 30, 2016 | July 31, 2015 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 24,018,782 | $ | 32,035,264 | ||||
| Prepaid expenses and other current assets | 1,000,503 | 1,532,717 | ||||||
| Total Current Assets | 25,019,285 | 33,567,981 | ||||||
| Property and equipment, net | 3,062,459 | 1,807,982 | ||||||
| Other long-term assets | 188,841 | 214,127 | ||||||
| Total Assets | $ | 28,270,585 | $ | 35,590,090 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Liabilities | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 3,160,331 | $ | 2,360,505 | ||||
| Accrued compensation | 517,170 | 501,446 | ||||||
| Total Current Liabilities | 3,677,501 | 2,861,951 | ||||||
| Other long-term liabilities | 606,173 | 32,518 | ||||||
| Total Liabilities | 4,283,674 | 2,894,469 | ||||||
| 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 — 16,971,214 and 14,820,854 common shares as of April 30, 2016 and July 31, 2015, respectively | 25,162 | 24,947 | ||||||
| Additional paid-in capital | 81,783,814 | 71,572,714 | ||||||
| Warrants issued and outstanding — 3,000,875 and 1,895,102 warrants as of April 30, 2016 and July 31, 2015, respectively | 9,110,598 | 7,704,103 | ||||||
| Accumulated deficit | (66,932,663 | ) | (46,606,143 | ) | ||||
| Total Stockholders’ Equity | 23,986,911 | 32,695,621 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 28,270,585 | $ | 35,590,090 | ||||
OncoSec Medical Incorporated
Condensed Statements of Operations (unaudited)
| Three Months Ended April 30, 2016 | Three Months Ended April 30, 2015 | Nine Months
Ended April 30, 2016 | Nine Months
Ended April 30, 2015 | |||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||
| Expenses: | ||||||||||||||||
| Research and development | 3,376,757 | 3,932,322 | 11,149,652 | 9,293,484 | ||||||||||||
| General and administrative | 2,874,362 | 2,053,964 | 9,174,406 | 5,371,245 | ||||||||||||
| Loss from operations | (6,251,119 | ) | (5,986,286 | ) | (20,324,058 | ) | (14,664,729 | ) | ||||||||
| Provision for income taxes | 290 | 1,059 | 2,462 | 1,969 | ||||||||||||
| Net loss | $ | (6,251,409 | ) | $ | (5,987,345 | ) | $ | (20,326,520 | ) | $ | (14,666,698 | ) | ||||
| Basic net loss per common share | $ | (0.37 | ) | $ | (0.48 | ) | $ | (1.27 | ) | $ | (1.19 | ) | ||||
| Diluted net loss per common share | $ | (0.37 | ) | $ | (0.48 | ) | $ | (1.27 | ) | $ | (1.19 | ) | ||||
| Weighted average shares used in computing basic net loss per common share | 16,971,214 | 12,349,693 | 15,955,116 | 12,347,450 | ||||||||||||
| Weighted average shares used in computing diluted net loss per common share | 16,971,214 | 12,349,693 | 15,955,116 | 12,347,450 | ||||||||||||
OncoSec Medical Incorporated
Condensed Statements of Cash Flows (unaudited)
| Nine Months
Ended April 30, 2016 | Nine Months
Ended April 30, 2015 | |||||||
| Operating activities | ||||||||
| Net loss | $ | (20,326,520 | ) | $ | (14,666,698 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 253,664 | 601,777 | ||||||
| Loss on disposal of property and equipment | 41,989 | 4,325 | ||||||
| Stock-based compensation | 4,676,215 | 1,650,550 | ||||||
| Common stock issued for services | — | 59,250 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Decrease (Increase) in prepaid expenses and other current assets | 532,214 | (550,688 | ) | |||||
| Decrease in other long-term assets | 25,286 | 6,625 | ||||||
| Increase in accounts payable and accrued liabilities | 461,617 | 466,051 | ||||||
| Increase in accrued compensation | 15,724 | — | ||||||
| Increase in other long-term liabilities | 573,654 | — | ||||||
| Net cash used in operating activities | (13,746,157 | ) | (12,428,808 | ) | ||||
| Investing activities | ||||||||
| Purchases of property and equipment | (1,156,420 | ) | (761,693 | ) | ||||
| Net cash used in investing activities | (1,156,420 | ) | (761,693 | ) | ||||
| 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 and stock options | — | 776,995 | ||||||
| Net cash provided by financing activities | 6,886,095 | 776,995 | ||||||
| Net (decrease) in cash | (8,016,482 | ) | (12,413,506 | ) | ||||
| Cash and cash equivalents, at beginning of period | 32,035,264 | 37,852,694 | ||||||
| Cash and cash equivalents, at end of period | $ | 24,018,782 | $ | 25,439,188 | ||||
| Supplemental disclosure for cash flow information: | ||||||||
| Cash paid during the period for: | ||||||||
| Interest | $ | — | $ | — | ||||
| Income taxes | $ | 2,463 | $ | 1,969 | ||||
| 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 March 2011 warrants | $ | 431,981 | $ | — | ||||
| R&D Equipment in use, but, financed through accounts payable and accrued liabilities | $ | 393,718 | $ | — | ||||