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