EX-99.1 2 ex99-1.htm

 

OncoSec Announces Fourth Quarter and Year End Results for Fiscal Year 2016

 

SAN DIEGO, October 13, 2016 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced financial results for the fourth quarter and fiscal year ended July 31, 2016.

 

“During the fourth quarter, we continued to advance the development of our lead clinical program, ImmunoPulse® IL-12, focused on the anti-PD1 non-responsive patient population in melanoma. The development of ImmunoPulse® IL-12 in combination with an anti-PD1 checkpoint inhibitor represents a potential immunotherapy for melanoma patients that are progressing on anti-PD1 therapy,” noted Punit Dhillon, President and Chief Executive Officer. “We have enrolled over 20 patients in our Phase II combination clinical study of ImmunoPulse® IL-12 with Merck’s KEYTRUDA® (pembrolizumab) in melanoma patients that are considered non-responders to anti-PD1, and OncoSec remains on track to announce interim data from approximately 15 of these patients at a three-month follow-up later this quarter. Subject to these interim results and discussions with the U.S. Food and Drug Administration, we expect to submit a registration directed study design for ImmunoPulse® IL-12 by the end of 2016. We have also continued to expand our research pipeline and broaden our engineering efforts relating to new devices that will be launched with our next clinical candidate. We look forward to discussing research and pre-clinical updates and timing data and clinical development milestones relating to our Melanoma program on our conference call and webcast on October 13th.”

 

FINANCIAL RESULTS

 

For the fourth quarter of fiscal 2016 and the fiscal year ended July 31, 2016, OncoSec reported a net loss of $6.6 million and $26.9 million, or $0.39 per share and $1.63 per share, respectively, compared to a net loss of $6.5 million and $21.2 million, or $0.48 per share and $1.67 per share, respectively, for the same period last year. The increase in net loss for the year ended July 31, 2016, compared with the same period in 2015, resulted primarily from (i) the progression of its clinical trials, (ii) consulting services costs to support its device development and clinical activities, (iii) facility costs related to its new corporate headquarters, and (iv) stock-based compensation expense. There were no revenues for the fiscal years ended July 31, 2016 or July 31, 2015.

 

Research and development expenses were $3.7 million and $14.8 million for the fourth quarter of fiscal 2016 and the fiscal year ended July 31, 2016, respectively, compared to $3.8 million and $13.1 million for the same periods in 2015. General and administrative expenses were $2.9 million and $12.1 million for the fourth quarter of fiscal 2016 and the fiscal year ended July 31, 2016, compared to $2.7 million and $8.1 million for the same period in 2015.

 

At July 31, 2016, OncoSec had $28.7 million in cash and cash equivalents, as compared to $32.0 million of cash and cash equivalents at July 31, 2015. 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

Balance Sheets

 

   July 31, 2016   July 31, 2015 
Assets          
Current assets          
Cash and cash equivalents  $28,746,224   $32,035,264 
Prepaid expenses   656,434    1,511,587 
Other current assets   14,750    21,130 
Total Current Assets   29,417,408    33,567,981 
Property and equipment, net   2,799,930    1,807,982 
Other long-term assets   189,309    214,127 
Total Assets  $32,406,647   $35,590,090 
           
Liabilities and Stockholders’ Equity          
           
Liabilities          
Current liabilities          
Accounts payable and accrued liabilities  $3,223,327   $2,360,505 
Accrued compensation related   242,924    501,446 
Total Current Liabilities   3,466,251    2,861,951 
Other long-term liabilities   887,292    32,518 
Total Liabilities   4,353,543    2,894,469 
           
Commitments and Contingencies (Note 9)          
           
Stockholders’ Equity          
Common stock authorized - 160,000,000 common shares with a par value of $0.0001, common stock issued and outstanding — 18,036,263 and 14,820,854 common shares as of July 31, 2016 and July 31, 2015, respectively (1)   25,269    24,947 
Additional paid-in capital   88,233,965    71,572,714 
Warrants issued and outstanding — 12,859,286 and 1,895,102 warrants as of July 31, 2016 and July 31, 2015, respectively (1)   13,288,527    7,704,103 
Accumulated deficit   (73,494,657)   (46,606,143)
Total Stockholders’ Equity   28,053,104    32,695,621 
Total Liabilities and Stockholders’ Equity  $32,406,647   $35,590,090 

 

 

(1) Effective May 18, 2015, the Company implemented a reverse stock split pursuant to which each 20 shares of issued and outstanding common stock held by each stockholder were combined into and became one share of common stock, with such resulting shares rounded up to the next whole share. No fractional shares were issued. All options, warrants and other convertible securities outstanding immediately prior to the reverse split were adjusted by dividing the number of shares of common stock into which the options, warrants and other convertible securities are exercisable or convertible by 20 and multiplying the exercise or conversion price by 20, all in accordance with the terms of the agreements governing such options, warrants and other convertible securities. The accompanying financial statement data for the annual prior periods presented have been retroactively adjusted to reflect the effects of the reverse stock split.

 

  
 

OncoSec Medical Incorporated

Statements of Operations

 

   Year Ended   Year Ended 
   July 31, 2016   July 31, 2015 
Revenue  $—   $— 
Expenses:          
Research and development   14,741,694    13,132,898 
General and administrative   12,144,358    8,108,244 
Loss from operations   (26,886,052)   (21,241,142)
Provision for income taxes   2,462    1,969 
Net loss  $(26,888,514)  $(21,243,111)
Basic and diluted net loss per common share (1)  $(1.63)  $(1.67)
Weighted average shares used in computing basic and diluted net loss per common share (1)   16,514,737    12,708,974

 

 

 

 

(1) Effective May 18, 2015, the Company implemented a reverse stock split pursuant to which each 20 shares of issued and outstanding common stock held by each stockholder were combined into and became one share of common stock, with such resulting shares rounded up to the next whole share. No fractional shares were issued. All options, warrants and other convertible securities outstanding immediately prior to the reverse split were adjusted by dividing the number of shares of common stock into which the options, warrants and other convertible securities are exercisable or convertible by 20 and multiplying the exercise or conversion price by 20, all in accordance with the terms of the agreements governing such options, warrants and other convertible securities. The accompanying financial statement data for the annual prior periods presented have been retroactively adjusted to reflect the effects of the reverse stock split.

 

  
 

OncoSec Medical Incorporated

Statements of Cash Flows

 

   Year Ended   Year Ended 
   July 31, 2016   July 31, 2015 
Operating activities          
Net loss  $(26,888,514)  $(21,243,111)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   355,583    664,596 
Stock-based compensation   6,116,660    2,547,729 
Stock-based compensation related to stock issuance liability in connection with a contractual agreement   —    55,500 
Common stock issued for services   55,387    57,750 
Loss on disposal of property and equipment   203,196    4,325 
Changes in operating assets and liabilities:          
(Increase) decrease in prepaid expenses   855,152    (1,068,699)
(Increase) decrease in other current   6,380    2,465 
(Increase) decrease in other long-term assets   24,818    (187,442)
(Decrease) increase in accounts payable and accrued liabilities   861,634    1,068,652 
(Decrease) increase in accrued compensation   (258,522)   459,592 
(Decrease) increase in other long-term liabilities   854,773    (12,027)
(Decrease) Increase in accrued income taxes   (800)   (800)
Net cash used in operating activities   (17,814,253)   (17,651,470)
Investing activities          
Purchases of property and equipment   (1,470,635)   (1,412,217)
Leasehold improvements   (80,102)   (18,938)
Net cash used in investing activities   (1,550,737)   (1,431,155)
Financing activities          
Proceeds from issuance of common stock and warrants   17,451,565    13,580,001 
Payment of financing and offering costs   (1,381,615)   (1,091,794)
Proceeds from exercise of warrants and stock options   6,000    776,988 
Net cash provided by financing activities   16,075,950    13,265,195 
Net increase (decrease) in cash   (3,289,040)   (5,817,430)
Cash and cash equivalents, at beginning of year   32,035,264    37,852,694 
Cash and cash equivalents, at end of year  $28,746,224   $32,035,264 
           
Supplemental disclosure for cash flow information:          
Cash paid during the period for:          
Interest  $—   $— 
Income taxes  $2,462   $1,969 
           
Noncash investing and financing transaction:          
Fair value of placement agent warrants issued in the public offerings  $536,909   $571,868 
Noncash expiration of March 2011 and June 2011 warrants  $963,356   $— 

 

  
 

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