UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): March 8, 2016

 

ONCOSEC MEDICAL INCORPORATED

(Exact name of registrant as specified in its charter)

 

Nevada

 

000-54318

 

98-0573252

(State or other jurisdiction

 

(Commission

 

(I.R.S. Employer

of incorporation)

 

File Number)

 

Identification No.)

 

5820 Nancy Ridge Drive
San Diego, California

 

92121

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (855) 662-6732

 

Not Applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 2.02.             Results of Operations and Financial Condition

 

On March 8, 2016, OncoSec Medical Incorporated (the “Company”) issued a press release regarding the Company’s financial results for the second quarter of the fiscal year ending July 31, 2016. A copy of the Company’s press release containing this information is being furnished as Exhibit 99.1 to this Current Report.

 

The information in this Current Report, including Exhibit 99.1 furnished herewith, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Current Report shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing to this Current Report.

 

Item 9.01.             Financial Statements and Exhibits.

 

(d)           Exhibits.

 

Exhibit

 

Description

99.1

 

OncoSec Medical Incorporated press release dated March 8, 2016

 

1



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

ONCOSEC MEDICAL INCORPORATED

 

 

Dated: March 8, 2016

By:

/s/ Punit Dhillon

 

 

Name: Punit Dhillon

 

 

Title: President & Chief Executive Officer

 

2




Exhibit 99.1

 

OncoSec Announces Second Quarter and YTD Results for Fiscal Year 2016 and Calendar 2016 Milestones

 

SAN DIEGO, March 8, 2016 — 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 second quarter and year to date ended January 31, 2016.

 

CORPORATE OBJECTIVES

 

“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. The fundamental goal of our technology, ImmunoPulse™ IL-12, is to promote a systemic, tumor-specific immune response. We believe this holds the greatest potential to provide meaningful clinical benefit to patients and investment value to OncoSec’s shareholders,” said Punit Dhillon, President and CEO of OncoSec. “Our objectives over the next year are focused on establishing clinical response data to support the combination rationale for ImmunoPulse™ IL-12 with anti-PD-1/PD-L1 as well as identifying a new lead candidate to expand our ImmunoPulse platform and deliver multiple immune molecules in a single treatment.”

 

OncoSec’s development milestones and value drivers over the next 12 months include:

 

·                  Complete patient enrollment in the Phase II combination trial of ImmunoPulse™ IL-12 with anti-PD-1 in patients with metastatic melanoma

 

·                  Present preliminary clinical and biomarker data from our Phase II melanoma clinical trials at upcoming scientific conferences; data to be used to finalize development strategy

 

·                  Identify novel “multi-gene” combination ImmunoPulse™ candidate

 

·                  Complete triple negative breast cancer pilot study as proof-of-concept and present interim data

 

·                  Present data from our preclinical programs, including studies with our existing industry collaborators

 

FINANCIAL RESULTS

 

For the second quarter of fiscal 2016 and the six months ended January 31, 2016, OncoSec reported a net loss of $7.0 million and $14.1 million, or $0.42 per share and $0.89 per share, respectively, compared to a net loss of $4.6 million and $8.7 million, or $0.38 per share and $0.71 per share, respectively, for the same periods last year. The increase in net loss for the year ended January 31, 2016, compared with the same period in 2015, resulted primarily from (i) an increase of $3.1 million in personnel costs, inclusive of non-cash stock-based compensation (ii) an increase of $1.3 million in clinical studies costs due to the progression of patient treatments in all of our clinical programs, (iii) an increase of $0.5 million related to outside services primarily associated with discovery research and next generation electroporation device development and (iv) an increase of $0.5 million in facility costs which consists primarily of rental expense due to the relocation of our Corporate headquarters, which includes onsite laboratory space. There were no revenues for the three and six months ended January 31, 2016 or January 31, 2015.

 

Research and development expenses were $4.1 million and $7.8 million for the second quarter of fiscal 2016 and the six months ended January 31, 2016, respectively, compared to $2.9 million and $5.4 million for the same periods in 2015. General and administrative expenses

 



 

were $2.9 million and $6.3 million for the second quarter of fiscal 2016 and the six months ended January 31, 2016, compared to $1.7 million and $3.3 million for the same period in 2015.

 

At January 31, 2016, OncoSec had $28.8 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 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 Phase II 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 “expect,” “may,” “will,” “goal,” “objective,” “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: 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 Balance Sheets

 

 

 

(unaudited)
January 31,
2016

 

July 31,
2015

 

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

28,845,271

 

$

32,035,264

 

Prepaid expenses and other current assets

 

1,219,218

 

1,532,717

 

Total Current Assets

 

30,064,489

 

33,567,981

 

Property and equipment, net

 

2,675,294

 

1,807,982

 

Other long-term assets

 

188,376

 

214,127

 

Total Assets

 

$

32,928,159

 

$

35,590,090

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

3,405,093

 

$

2,360,505

 

Accrued compensation

 

605,683

 

501,446

 

Total Current Liabilities

 

4,010,776

 

2,861,951

 

Other long-term liabilities

 

325,053

 

32,518

 

Total Liabilities

 

4,335,829

 

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 January 31, 2016 and July 31, 2015, respectively

 

25,162

 

24,947

 

Additional paid-in capital

 

79,705,843

 

71,572,714

 

Warrants issued and outstanding — 3,073,675 and 1,895,102 warrants as of January 31, 2016 and July 31, 2015, respectively

 

9,542,579

 

7,704,103

 

Accumulated deficit

 

(60,681,254

)

(46,606,143

)

Total Stockholders’ Equity

 

28,592,330

 

32,695,621

 

Total Liabilities and Stockholders’ Equity

 

$

32,928,159

 

$

35,590,090

 

 



 

OncoSec Medical Incorporated

Condensed Statements of Operations (unaudited)

 

 

 

Three Months
Ended January 
31, 2016

 

Three Months
Ended January 
31, 2015

 

Six Months
Ended
January 31, 2016

 

Six Months
Ended
January 31, 2015

 

Revenue

 

$

 

$

 

$

 

$

 

Expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

4,113,582

 

2,859,894

 

7,772,895

 

5,361,162

 

General and administrative

 

2,924,138

 

1,758,343

 

6,300,044

 

3,317,281

 

Loss from operations

 

(7,037,720

)

(4,618,237

)

(14,072,939

)

(8,678,443

)

Net loss before income taxes

 

(7,037,720

)

(4,618,237

)

(14,072,939

)

(8,678,443

)

Provision for income taxes

 

 

 

2,172

 

910

 

Net loss

 

$

(7,037,720

)

$

(4,618,237

)

$

(14,075,111

)

$

(8,679,353

)

Basic net loss per common share (1)

 

$

(0.42

)

$

(0.38

)

$

(0.89

)

$

(0.71

)

Diluted net loss per common share (1)

 

$

(0.42

)

$

(0.38

)

$

(0.89

)

$

(0.71

)

Weighted average shares used in computing basic net loss per common share (1)

 

16,761,586

 

12,312,582

 

15,794,970

 

12,272,068

 

Weighted average shares used in computing diluted net loss per common share (1)

 

16,761,586

 

12,312,582

 

15,794,970

 

12,272,068

 

 


(1) Recast due to May 2015 reverse stock split.

 



 

OncoSec Medical Incorporated

Condensed Statements of Cash Flows (unaudited)

 

 

 

Six
Months
Ended
January 31,
2016

 

Six
Months
Ended
January 31,
2015

 

Operating activities

 

 

 

 

 

Net loss

 

$

(14,075,111

)

$

(8,679,353

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Depreciation and amortization

 

151,601

 

431,650

 

Loss on disposal of property and equipment

 

41,989

 

2,636

 

Stock-based compensation

 

3,030,225

 

1,016,771

 

Common stock issued for services

 

 

30,000

 

Changes in operating assets and liabilities:

 

 

 

 

 

(Increase) in prepaid expenses and other current assets

 

313,499

 

(163,758

)

(Increase) decrease in other long-term assets

 

25,751

 

(186,533

)

Increase in accounts payable and accrued liabilities

 

1,100,097

 

181,632

 

Increase in accrued compensation

 

104,237

 

 

Increase in other long-term liabilities

 

292,534

 

 

Net cash used in operating activities

 

(9,015,178

)

(7,366,955

)

Investing activities

 

 

 

 

 

Purchases of property and equipment

 

(1,060,910

)

(563,516

)

Net cash used in investing activities

 

(1,060,910

)

(563,516

)

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

 

(3,189,993

)

(7,153,476

)

Cash and cash equivalents, at beginning of period

 

32,035,264

 

37,852,694

 

Cash and cash equivalents, at end of period

 

$

28,845,271

 

$

30,699,218

 

 

 

 

 

 

 

Supplemental disclosure for cash flow information:

 

 

 

 

 

Cash paid during the period for:

 

 

 

 

 

Interest

 

$

 

$

 

Income taxes

 

$

2,172

 

$

910

 

 

 

 

 

 

 

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

 

$

 

 


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