UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE

ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED APRIL 30, 2022

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE

ACT OF 1934

FOR THE TRANSITION PERIOD FROM __ TO __

COMMISSION FILE NO. 000-54318

ONCOSEC MEDICAL INCORPORATED

(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)

nevada		98-0573252
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)

24 NORTH MAIN STREET
PENNINGTON, NJ		08534
(Address of principal executive offices)		(Zip Code)

(855) 662-6732

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Exchange Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		ONCS		Nasdaq Capital Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The number of shares outstanding of the Registrant’s Common Stock, $0.0001 par value, was 39,365,543 as of June 14, 2022.

OncoSec Medical Incorporated

Form 10-Q

for the Quarterly Period Ended April 30, 2022

PART I—FINANCIAL INFORMATION		3
Item 1.	Financial Statements:	3
	Condensed Consolidated Balance Sheets as of April 30, 2022 (unaudited) and July 31, 2021	3
	Condensed Consolidated Statements of Operations for the three and nine months ended April 30, 2022 and 2021 (unaudited)	4
	Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended April 30, 2022 and 2021 (unaudited)	5
	Condensed Consolidated Statements of Stockholders’ Equity for the three and nine months ended April 30, 2022 and 2021 (unaudited)	6
	Condensed Consolidated Statements of Cash Flows for the nine months ended April 30, 2022 and 2021 (unaudited)	8
	Notes to Condensed Consolidated Financial Statements (unaudited)	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	28
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	36
Item 4.	Controls and Procedures	37
PART II—OTHER INFORMATION		37
Item 1.	Legal Proceedings	37
Item 1A.	Risk Factors	37
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	38
Item 3.	Defaults Upon Senior Securities	38
Item 4.	Mine Safety Disclosures	38
Item 5.	Other Information	38
Item 6.	Exhibits	38
SIGNATURES		39

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

OncoSec Medical Incorporated

Condensed Consolidated Balance Sheets

		April 30, 2022			July 31, 2021
	(Unaudited)
Assets
Current assets
Cash and cash equivalents	$	19,477,493		$	45,951,233
Prepaid expenses and other current assets		1,658,436			3,228,191
Total Current Assets		21,135,929			49,179,424
Property and equipment, net		1,023,728			928,821
Intangible assets, net		396,000			448,412
Operating lease right-of-use assets		4,910,443			5,445,744
Other long-term assets		528,090			273,523
Total Assets	$	27,994,190		$	56,275,924

Liabilities and Stockholders’ Equity

Liabilities
Current liabilities
Accounts payable and accrued liabilities	$	3,145,828		$	5,561,645
Accrued compensation related		342,881			320,655
Operating lease liabilities		1,073,440			845,483
Note payable		124,755			1,234,133
Total Current Liabilities		4,686,904			7,961,916
Operating lease liabilities, net of current portion		4,418,671			5,238,207
Liability under co-promotion agreement - related party		5,000,000			5,000,000
Total Liabilities		14,105,575			18,200,123

Commitments and Contingencies (Note 9)		-

Stockholders’ Equity
Common stock authorized – 100,000,000 common shares with a par value of $0.0001 as of April 30, 2022 and July 31, 2021, common stock issued and outstanding – 39,364,449 and 39,152,610 common shares as of April 30, 2022 and July 31, 2021, respectively		3,937			3,916
Additional paid-in capital		287,855,594			286,337,291
Warrants issued and outstanding – 1,706,190 warrants as of April 30, 2022 and July 31, 2021		3,591,734			3,591,734
Accumulated other comprehensive income (loss)		178,731			(79,109	)
Accumulated deficit		(277,741,381	)		(251,778,031	)
Total Stockholders’ Equity		13,888,615			38,075,801
Total Liabilities and Stockholders’ Equity	$	27,994,190		$	56,275,924

The accompanying notes are an integral part of these condensed consolidated financial statements.

OncoSec Medical Incorporated

Condensed Consolidated Statements of Operations

(Unaudited)


	Three Months Ended						Nine Months Ended
	April 30, 2022			April 30, 2021			April 30, 2022			April 30, 2021
Revenue	$	-		$	-		$	-		$	-
Expenses:
Research and development		7,030,607			7,589,779			20,501,917			26,304,520
General and administrative		2,517,105			2,847,151			8,377,722			8,198,580
Loss from operations		(9,547,712	)		(10,436,930	)		(28,879,639	)		(34,503,100	)
Gain on extinguishment of debt		-			960,790			-			960,790
Other income (expense), net		2,182			1,723			(2,412	)		660
Interest expense		(2,701	)		(1,732	)		(16,128	)		(12,587	)
Foreign currency exchange gain (loss), net		(36,191	)		35,365			(399,338	)		187,039
Loss before income taxes		(9,584,422	)		(9,440,784	)		(29,297,517	)		(33,367,198	)
Income tax (benefit) expense		(3,337,117	)		1,542			(3,334,167	)		4,492
Net loss	$	(6,247,305	)	$	(9,442,326	)	$	(25,963,350	)	$	(33,371,690	)
Basic and diluted net loss per common share	$	(0.16	)	$	(0.25	)	$	(0.66	)	$	(1.08	)
Weighted average shares used in computing basic and diluted net loss per common share		39,355,672			37,335,563			39,281,841			30,857,405

The accompanying notes are an integral part of these condensed consolidated financial statements.

OncoSec Medical Incorporated

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)


	Three Months Ended						Nine Months Ended
	April 30, 2022			April 30, 2021			April 30, 2022			April 30, 2021

Net Loss	$	(6,247,305	)	$	(9,442,326	)	$	(25,963,350	)	$	(33,371,690	)
Foreign currency translation adjustments		4,857			(70,491	)		257,840			(336,310	)
Comprehensive Loss	$	(6,242,448	)	$	(9,512,817	)	$	(25,705,510	)	$	(33,708,000	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

OncoSec Medical Incorporated

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

Three Months Ended April 30, 2022

	Shares		Amount		Capital			Shares		Amount		Loss		Deficit			Equity
	Common Stock				Additional Paid-In			Warrants				Accumulated Other Comprehensive		Accumulated			Total Stockholders’
	Shares		Amount		Capital			Shares		Amount		Loss		Deficit			Equity
Balance, January 31, 2022		39,349,269	$	3,935	$	287,539,711			1,706,190	$	3,591,734	$	173,874	$	(271,494,076	)	$	19,815,178
Stock-based compensation expense		15,180		2		315,697			—		—		—		—			315,699
Tax withholdings paid on equity awards		—		—		(10,378	)		—		—		—		—			(10,378	)
Tax shares sold to pay for tax withholdings on equity awards		—		—		10,564			—		—		—		—			10,564
Other comprehensive income		—		—		—			—		—		4,857		—			4,857
Net loss		—		—		—			—		—		—		(6,247,305	)		(6,247,305	)
Balance, April 30, 2022		39,364,449	$	3,937	$	287,855,594			1,706,190	$	3,591,734	$	178,731	$	(277,741,381	)	$	13,888,615

Nine Months Ended April 30, 2022

	Common Stock				Additional Paid-In			Warrants				Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Capital			Shares		Amount		Loss			Deficit			Equity
Balance, July 31, 2021		39,152,610	$	3,916	$	286,337,291			1,706,190	$	3,591,734	$	(79,109	)	$	(251,778,031	)	$	38,075,801
Stock-based compensation expense		67,839		7		1,272,266			—		—		—			—			1,272,273
Tax withholdings paid on equity awards		—		—		(43,383	)		—		—		—			—			(43,383	)
Tax shares sold to pay for tax withholdings on equity awards		—		—		42,949			—		—		—			—			42,949
Common stock issued for services		12,500		1		42,499			—		—		—			—			42,500
Exercise of common stock options		130,000		13		202,787			—		—		—			—			202,800
Common stock issued for employee stock purchase plan		1,500		—		1,185			—		—		—			—			1,185
Other comprehensive income		—		—		—			—		—		257,840			—			257,840
Net loss		—		—		—			—		—		—			(25,963,350	)		(25,963,350	)
Balance, April 30, 2022		39,364,449	$	3,937	$	287,855,594			1,706,190	$	3,591,734	$	178,731		$	(277,741,381	)	$	13,888,615

The accompanying notes are an integral part of these condensed consolidated financial statements.

Three Months Ended April 30, 2021

														Accumulated
					Additional									Other						Total
	Common Stock				Paid-In			Warrants						Comprehensive			Accumulated			Stockholders’
	Shares		Amount		Capital			Shares			Amount			Loss			Deficit			Equity
Balance, January 31, 2021		36,491,976	$	3,649	$	274,633,208			2,221,315		$	4,330,949		$	(285,323	)	$	(230,539,664	)	$	48,142,819
Exercise of common stock warrants		507,000		51		2,401,358			(507,000	)		(652,259	)		—			—			1,749,150
Exercise of common stock options		136,636		13		227,840			—			—			—			—			227,853
Stock-based compensation expense		6,541		1		841,569			—			—			—			—			841,570
Tax withholdings paid on equity awards		—		—		(26,979	)		—			—			—			—			(26,979	)
Tax shares sold to pay for tax withholdings on equity awards		—		—		26,142			—			—			—			—			26,142
Purchase of shares under CGP and Sirtex stock purchase agreements		1,691,806		169		5,836,562			—			—			—			—			5,836,731
Common stock issued for services		37,500		4		127,496			—			—			—			—			127,500
Dividends declared ($0.00 per share)		—		—		—			—			—			—			—			—
Net loss		—		—		—			—			—			—			(9,442,326	)		(9,442,326	)
Other comprehensive loss		—		—		—			—			—			(70,491	)		—			(70,491	)
Balance, April 30, 2021		38,871,459	$	3,887	$	284,067,196			1,714,315		$	3,678,690		$	(355,814	)	$	(239,981,990	)	$	47,411,969

Nine Months Ended April 30, 2021

														Accumulated
					Additional									Other						Total
	Common Stock				Paid-In			Warrants						Comprehensive			Accumulated			Stockholders’
	Shares		Amount		Capital			Shares			Amount			Loss			Deficit			Equity
Balance, July 31, 2020		23,054,474	$	2,305	$	214,789,808			3,114,288		$	5,708,127		$	(19,504	)	$	(206,610,300	)	$	13,870,436
Common stock issued for employee stock purchase plan		1,538		—		5,798			—			—			—			—			5,798
Exercise of common stock warrants		1,389,261		139		6,580,106			(1,389,261	)		(1,787,294	)		—			—			4,792,951
Exercise of common stock options		294,884		30		489,550			—			—			—			—			489,580
Stock-based compensation expense		19,623		2		3,213,748			—			—			—			—			3,213,750
Tax withholdings paid on equity awards		—		—		(53,438	)		—			—			—			—			(53,438	)
Tax shares sold to pay for tax withholdings on equity awards		—		—		54,191			—			—			—			—			54,191
Cancellation of expired warrants		—		—		242,143			(10,712	)		(242,143	)		—			—			—
August 2020 Registered Direct Offering, net of $1,464,276 issuance costs		4,608,589		461		13,513,177			—			—			—			—			13,513,638
January 2021 Public Offering, net of $2,970,165 issuance costs		7,711,284		771		39,055,561			—			—			—			—			39,056,332
Purchase of shares under CGP and Sirtex stock purchase agreements		1,691,806		169		5,836,562			—			—			—			—			5,836,731
Common stock issued for services		100,000		10		339,990			—			—			—			—			340,000
Dividends declared ($0.00 per share)		—		—		—			—			—			—			—			—
Net loss		—		—		—			—			—			—			(33,371,690	)		(33,371,690	)
Other comprehensive loss		—		—		—			—			—			(336,310	)		—			(336,310	)
Other comprehensive income (loss)		—		—		—			—			—			(336,310	)		—			(336,310	)
Balance, April 30, 2021		38,871,459	$	3,887	$	284,067,196			1,714,315		$	3,678,690		$	(355,814	)	$	(239,981,990	)	$	47,411,969

The accompanying notes are an integral part of these condensed consolidated financial statements.

OncoSec Medical Incorporated

Condensed Consolidated Statements of Cash Flows

(Unaudited)

		April 30, 2022			April 30, 2021
	Nine Months Ended
	April 30, 2022			April 30, 2021
Operating activities
Net loss	$	(25,963,350	)	$	(33,371,690	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		194,700			172,074
Amortization of right-of-use asset		564,102			626,486
Stock-based compensation		1,272,273			3,213,750
Common stock issued for services		42,500			340,000
Foreign currency exchange (gain) loss, net		399,338			(187,039	)
Gain on extinguishment of debt		—			(960,790	)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		1,561,333			681,630
Other long-term assets		(290,876	)		(28	)
Accounts payable and accrued liabilities		(2,432,847	)		(3,458,989	)
Accrued compensation related		22,226			(36,343	)
Operating lease liabilities		(591,579	)		(406,462	)
Net cash used in operating activities		(25,222,180	)		(33,387,401	)

Investing activities
Purchase of property and equipment		(244,857	)		(259,662	)
Purchase of intangible assets		—			(495,000	)
Net cash used in investing activities		(244,857	)		(754,662	)

Financing activities
Proceeds from issuance of common stock through ESPP		1,185			5,798
Proceeds from issuance of common stock		—			57,004,411
Payment of financing and offering costs		(15,500	)		(4,434,441	)
Proceeds from exercise of warrants		—			4,792,951
Proceeds from exercise of stock options		202,800			489,580
Purchase of shares under CGP and Sirtex stock purchase agreements		—			5,836,731
Proceeds from co-promotion agreement		—			5,000,000
Principal payments on note payable		(1,109,378	)		(497,319	)
Tax withholdings paid on equity awards		(43,383	)		(53,438	)
Tax shares sold to pay for tax withholdings on equity awards		42,949			54,191
Net cash provided by (used in) financing activities		(921,327	)		68,198,464
Effect of exchange rate changes on cash and cash equivalents		(85,376	)		(18,362	)
Net increase (decrease) in cash and cash equivalents		(26,473,740	)		34,038,039
Cash and cash equivalents, at beginning of period		45,951,233			20,354,462
Cash and cash equivalents, at end of period	$	19,477,493		$	54,392,501

Supplemental disclosure for cash flow information:
Cash paid during the period for:
Interest	$	16,128		$	7,032
Income taxes	$	2,950		$	4,492
Noncash investing and financing transactions:
Expiration of warrants	$	—		$	242,143
Increase in right-of-use assets and operating lease liabilities resulting from contract modification	$	—		$	338,819

The accompanying notes are an integral part of these condensed consolidated financial statements.

OncoSec Medical Incorporated

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Note 1—Nature of Operations and Basis of Presentation

OncoSec Medical Incorporated (together with its subsidiary, unless the context indicates otherwise, being collectively referred to as the “Company”) began its operations as a biotechnology company in March 2011. The Company has not generated any revenues since its inception. The Company was incorporated in the State of Nevada on February 8, 2008 under the name of Netventory Solutions, Inc. and changed its name to OncoSec Medical Incorporated in March 2011 when it began operating as a biotechnology company.

The Company is a late-stage immuno-oncology company focused on designing, developing and commercializing innovative, proprietary, intra-tumoral DNA-based therapeutics to stimulate and augment anti-tumor immune responses for the treatment of cancers. Its core technology platform ImmunoPulse® is a drug-device therapeutic modality platform comprised of a proprietary intratumoral electroporation (“EP”) delivery device (the “OMS EP Device”) and a proprietary DNA plasmid that triggers transient expression of target protein in cells. The OMS EP Device is designed to deliver plasmid DNA-encoded drugs directly into a solid tumor and promote an immunological response against the cancer. The OMS EP Device can be adapted to treat different tumor types, and consists of an electrical pulse generator and disposable applicators. The Company’s lead product candidate is a DNA-encoded interleukin-12 (“IL-12”) called tavokinogene telseplasmid (“TAVO™”). The OMS EP Device is used to deliver TAVO™ intratumorally, with the aim of reversing the immunosuppressive microenvironment in the treated tumor and elicit systemic tumor-specific immune responses in cancer patients. The activation of the appropriate inflammatory response in the treated tumor can drive a systemic anti-tumor response against untreated tumors in other parts of the body. In 2017, the Company received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (“FDA”) for TAVO™ in metastatic melanoma, which could qualify TAVO™ for expedited FDA review, a rolling Biologics License Application (“BLA”) review and certain other benefits.

The Company’s primary focus is to pursue its study of TAVO™ in combination with KEYTRUDA® (pembrolizumab) in melanoma and triple negative breast cancer (“TNBC”).

The Company’s KEYNOTE-695 study is a registration-directed, Phase 2b open-label, single-arm, multicenter study in approximately 100 patients treated with TAVO™ in combination with KEYTRUDA® (pembrolizumab) in anti-PD-1 checkpoint inhibitor (nivolumab or pembrolizumab) relapsed or refractory metastatic melanoma, being conducted in the United States, Canada, Australia and Europe. In May 2017, the Company entered into a clinical trial collaboration and supply agreement with a subsidiary of Merck & Co., Inc. (“Merck”) in connection with the KEYNOTE-695 study. Pursuant to the terms of the agreement, each company will bear its own costs related to manufacturing and supply of its product, as well as be responsible for its own internal costs. The Company is the study sponsor and is responsible for external costs. The study completed enrollment of the primary cohort in December 2020. In December 2020, the protocol was amended to include an additional cohort, consisting of patients who were exposed to treatment with ipilimumab and progressed on prior anti-PD-1 checkpoint inhibitor. The amendment also enabled enrollment of approximately 25 additional patients to be treated with an updated version of the OMS EP Device (i.e., GenPulse^TMgenerator and Series 3 Applicator), in preparation for seeking FDA approval.

The Company’s KEYNOTE-890 study is a Phase 2, open-label, single-arm, multicenter study conducted in the United States and Australia to evaluate the safety and efficacy of TAVO™ in combination with KEYTRUDA® in patients with inoperable locally advanced or metastatic TNBC who have previously failed at least one systemic chemotherapy or immunotherapy (Cohort 1) or TAVO™ in combination with KEYTRUDA® and chemotherapy in patients with inoperable locally advanced or metastatic TNBC who have had no prior systemic therapy in the advanced or metastatic setting (Cohort 2). In May 2018, the Company entered into a second clinical trial collaboration and supply agreement with a subsidiary of Merck with respect to the KEYNOTE-890 study, Cohort 1. Pursuant to the terms of the agreement, each company will bear its own costs related to manufacturing and supply of its product, as well as be responsible for its own internal costs. The Company is the study sponsor and is responsible for external costs. In June 2020, the Company amended its second clinical trial collaboration and supply agreement to include KEYNOTE-890, Cohort 2. Enrollment of Cohort 1 was completed (26 patients) in December 2020. Interim data for Cohort 1 was initially presented at the San Antonio Breast Cancer Symposium (“SABCS”) in December 2019, and an update on this cohort was presented at the SABCS in December 2021. Enrollment of Cohort 2 (target 40 patients) began in January 2021 and is expected to be completed in 2023.

In May 2019, the Company supported commencement of an investigator-initiated Phase 1 clinical trial conducted by the University of California San Francisco (“UCSF”) Helen Diller Family Comprehensive Cancer Center. This study targets patients with Squamous Cell Carcinoma of the Head & Neck and is a single-arm open-label clinical trial in which 68 evaluable patients will receive TAVO™, KEYTRUDA® and epacadostat. Recruitment on this study has been halted after the last patient was treated in June 2021.

In August 2020, the Company supported commencement of an investigator-initiated Phase 2 study conducted by the H. Lee Moffitt Cancer Center and Research Institute and the University of South Florida Morsani College of Medicine to evaluate TAVO™ as neoadjuvant treatment (administered before surgery) in combination with intravenous OPDIVO® (nivolumab) in up to 33 patients with operable locally/regionally advanced melanoma. This study has been designed to evaluate whether the addition of TAVO™ can increase the published anti-tumor response observed with monotherapy OPDIVO®, an anti-PD-1 checkpoint inhibitor, in patients with locally/regionally advanced melanoma prior to surgical resection of tumors. This study began enrolling patients in December of 2020. Enrollment for this trial is expected to be completed in 2023.

In November 2020, the Company obtained an exclusive license to the Cliniporator® electroporation gene electrotransfer platform from IGEA Clinical Biophysics. This platform has been used for electrochemotherapy in and outside of Europe in over 200 major oncological centers to treat cutaneous metastatic cancer nodules, including melanoma. The license encompasses a broad field of use for gene delivery in oncology, including use as part of the Company’s visceral lesion applicator (“VLA”) program.

In April 2021, the Company announced that it received authorization to CE mark the OMS EP Device for use in solid tumors. That CE mark indicates compliance with Medical Device Directives (MDD) of the European Commission for the OMS EP Device as configured at the time. Subsequent to receiving the CE mark for that version of the OMS EP Device, the Company has advanced the design of the applicator component of the OMS EP Device, which the Company refers to as the Series 3 Applicator. This newer version of the OMS EP Device, which still includes the GenPulse^TM generator, is currently used as an investigational device in clinical trial sites in Australia, the EU and Switzerland. The Company is currently seeking FDA agreement for investigational use of the GenPulse^TM and the Series 3 Applicator in US clinical sites.

The Company intends to continue to pursue potential new trials and studies related to TAVO™, in various tumor types. In addition, the Company is also developing its next-generation EP device and applicator, including advancements toward prototypes, pursuing discovery research to identify other product candidates that, in addition to IL-12, can be encoded into proprietary plasmid-DNA and delivered intratumorally using EP. Specifically, the Company is developing proprietary technology to potentially treat liver, lung, bladder, pancreatic and other difficult to treat visceral lesions through the direct delivery of plasmid-based IL-12 with the VLA.

The VLA is being designed to work with low voltage EP generators, including but not limited to the Company’s proprietary APOLLO^TMEP generator and Cliniporator^®, and is expected to enable transfection of immunologically relevant genes into cells located in visceral organs. In early 2020, the Company had two poster presentations, one at the Society for Interventional Oncology and one at the Society for Interventional Radiology, where it presented preclinical data pertaining to visceral delivery of plasmid therapy. Additionally, the Company has successfully completed several large animal studies to assess VLA design. The Company expected to bring a VLA into the clinic in 2023. However, this timeline is under evaluation and may extend beyond 2023. The Company believes that the flexibility of the Company’s proprietary plasmid-DNA technology allows the Company to deliver other immunologically relevant molecules into the tumor microenvironment in addition to the delivery of plasmid-DNA encoding for IL-12.

The Company established a collaboration with Emerge Health Pty (“Emerge”), the leading Australian company providing full registration, reimbursement, sales, marketing and distribution services of therapeutic products in Australia and New Zealand, to commercialize TAVO™ and make it available under Australia’s Special Access Scheme (“SAS”). Emerge was acquired in late 2019 and in June 2021 informed the Company that oncology will not be a core therapeutic focus for Emerge into the future. The collaboration was terminated effective October 1, 2021, and the Company will not continue to participate in the SAS program.

Unaudited Interim Financial Information

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated balance sheet as of April 30, 2022, the condensed consolidated statements of operations for the three and nine months ended April 30, 2022 and 2021, the condensed consolidated statements of comprehensive loss for the three and nine months ended April 30, 2022 and 2021, the condensed consolidated statements of stockholders’ equity for the three and nine months ended April 30, 2022 and 2021, and the condensed consolidated statements of cash flows for the nine months ended April 30, 2022 and 2021, are unaudited, but include all adjustments (consisting of normal recurring adjustments) that, in the opinion of management, are necessary for a fair presentation of the Company’s financial position, results of operations and cash flows for the periods presented and necessary in order to make the Company’s financial statements not misleading. The condensed consolidated results of operations for the three and nine months ended April 30, 2022 shown herein are not necessarily indicative of the consolidated results that may be expected for the year ending July 31, 2022, or for any other period. These condensed consolidated financial statements, and notes thereto, should be read in conjunction with the audited consolidated financial statements for the fiscal year ended July 31, 2021, included in the Company’s Annual Report on Form 10-K (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (“SEC”) on October 29, 2021. The condensed consolidated balance sheet at July 31, 2021 has been derived from the audited financial statements at that date but does not include all the information and footnotes required by U.S. GAAP for complete financial statements.

Note 2—Significant Accounting Policies

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, OncoSec Medical Australia PTY LTD. All significant intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

The accompanying condensed consolidated financial statements have been prepared in conformity with U.S. GAAP, which requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Such estimates include the Company’s ability to continue as a going concern and certain calculations related to that determination, stock-based compensation, the accrual of research, product development and clinical obligations, impairment of long-lived assets, determining the Incremental Borrowing Rate for calculating Right-Of-Use (“ROU”) assets and lease liabilities and accounting for income taxes, including the related valuation allowance on the deferred tax asset and uncertain tax positions. The Company bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. On an ongoing basis, the Company reviews its estimates to ensure that they appropriately reflect changes in the business or as new information becomes available. Actual results may differ from these estimates.

Segment Reporting

The Company operates in a single industry segment—the discovery and development of novel immunotherapeutic product candidates to improve treatment options for patients and physicians, intended to treat a wide range of oncology indications.

Cash and Cash Equivalents

The Company considers all highly liquid investments that are readily convertible into cash and have an original maturity of three months or less at the time of purchase to be cash equivalents.

Concentrations and Credit Risk

The Company maintains cash balances at a small number of financial institutions in both the United States and Australia and such balances commonly exceed the $250,000 amount insured by the Federal Deposit Insurance Corporation and $250,000 AUD (approximately $176,000 USD) insured by the Australian Financial Claims Scheme. The Company has not experienced any losses in such accounts and management believes that the Company does not have significant credit risk with respect to such cash and cash equivalents.

Property and Equipment

The Company’s capitalization threshold is $5,000 for property and equipment. The cost of property and equipment is depreciated on a straight-line basis over the estimated useful lives of the related assets. The useful lives of property and equipment for the purpose of computing depreciation are as follows:

Computers and equipment:		3 to 10 years
Computer software:		1 to 3 years
Leasehold improvements:		Shorter of lease period or useful life

Construction-in-progress is stated at cost, which relates to the cost of equipment not yet placed into service. No depreciation expense is recorded on construction-in-progress until such time as the relevant assets are completed and put into use.

Intangible Assets

Definite life intangible assets include a license. Intangible assets are recorded at cost. License agreement cost represents the fair value of the license agreement on the date acquired. Intangible assets are amortized on a straight-line basis over their estimated useful life.

Impairment of Long-Lived Assets

The Company periodically assesses the carrying value of intangible and other long-lived assets, and whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. The assets are considered to be impaired if the Company determines that the carrying value may not be recoverable based upon its assessment, which includes consideration of the following events or changes in circumstances:

	●	the asset’s ability to continue to generate income from operations and positive cash flow in future periods;

	●	loss of legal ownership or title to the asset(s);

	●	significant changes in the Company’s strategic business objectives and utilization of the asset(s); and

	●	the impact of significant negative industry or economic trends.

If the assets are considered to be impaired, the impairment recognized is the amount by which the carrying value of the assets exceeds the fair value of the assets. Fair value is determined by the application of discounted cash flow models to project cash flows from the assets. In addition, the Company bases estimates of the useful lives and related amortization or depreciation expense on its subjective estimate of the period the assets will generate revenue or otherwise be used by it. Assets to be disposed of are reported at the lower of the carrying amount or fair value, less selling costs. The Company also periodically reviews the lives assigned to long-lived assets to ensure that the initial estimates do not exceed any revised estimated periods from which the Company expects to realize cash flows from its assets.

Research and Development Expenses

Research and development expenses consist of costs incurred for internal projects, as well as partner-funded collaborative research and development activities. These costs include direct and research-related overhead expenses, which include salaries, stock-based compensation and other personnel-related expenses, facility costs, supplies, depreciation of facilities and laboratory equipment, as well as research consultants and the cost of funding research at universities and other research institutions, and are expensed as incurred. Costs to acquire technologies that are utilized in research and development that have no alternative future use, are expensed when incurred. In accordance with Accounting Standards Codification (“ASC”) 730-20, the Company accounts for upfront, non-refundable research and development payments received from a related party as a long-term liability as there has not been a substantive and genuine transfer of risk and there is a presumption that the Company is obligated to repay the related party.

Accruals for Research and Development Expenses and Clinical Trials

The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company accounts for these expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company determines accrual estimates through financial models and takes into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates.

Fair Value of Financial Instruments

The carrying amounts for cash and cash equivalents, prepaid expenses, accounts payable and accrued expenses and notes payable approximate fair value due to the short-term nature of these instruments. It is management’s opinion that the Company is not exposed to significant interest, currency, or credit risks arising from its other financial instruments and that their fair values approximate their carrying values except where expressly disclosed.

The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in the absence of a principal, most advantageous market for the specific asset or liability.

The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value.

The three tiers are defined as follows:

●	Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets at the measurement date. Since valuations are based on quoted prices that are readily and regularly available in an active market, valuation of these products does not entail a significant degree of judgment.

●	Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities.

●	Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement.

The development and determination of the unobservable inputs for Level 3 fair value measurements and fair value calculations are the responsibility of the Company’s management.

Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate.

The Company had no assets or liabilities that required remeasurement on a recurring basis as of April 30, 2022 and July 31, 2021.

Warrants

The Company assesses its warrants as either equity or a liability based upon the characteristics and provisions of each instrument. Warrants classified as equity are recorded at fair value as of the date of issuance on the Company’s balance sheet and no further adjustments to their valuation are made. Warrants classified as derivative liabilities and other derivative financial instruments that require separate accounting as liabilities are recorded on the Company’s balance sheet at their fair value on the date of issuance and are re-measured on each subsequent balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods recorded as other income or expense. Management estimates the fair value of these liabilities using option pricing models and assumptions that are based on the individual characteristics of the warrants or other instruments on the valuation date, as well as assumptions for future financings, expected volatility, expected life, yield and risk-free interest rate. As of April 30, 2022 and July 31, 2021, all outstanding warrants issued by the Company were classified as equity.

Net Loss Per Share

The Company computes basic net loss per common share by dividing the applicable net loss by the weighted-average number of common shares outstanding during the period. Diluted earnings per share is computed by dividing the applicable net loss by the weighted-average number of common shares outstanding during the period plus additional shares to account for the dilutive effect of potential future issuances of common stock relating to stock options and other potentially dilutive securities using the treasury stock method.

The Company did not include shares underlying stock options, restricted stock units and warrants issued and outstanding during any of the periods presented in the computation of net loss per share, as the effect would have been anti-dilutive. The following potentially dilutive outstanding securities were excluded from diluted net loss per share because of their anti-dilutive effect:

	For the Three and Nine Months Ended		For the Three and Nine Months Ended
	April 30, 2022		April 30, 2021
Stock options		2,323,314		2,491,898
Restricted stock units		74,805		21,541
Warrants		1,706,190		1,714,315
Total		4,104,309		4,227,754

Stock-Based Compensation

The Company grants equity-based awards (typically stock options or restricted stock units) under its stock-based compensation plan and occasionally outside of its stock-based compensation plan, with terms generally similar to the terms under the Company’s stock-based compensation plan. The Company estimates the fair value of stock option awards using the Black-Scholes option valuation model. For employees, directors and consultants, the fair value of the award is measured on the grant date. The fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. The Company estimates the fair value of restricted stock unit awards based on the closing price of the Company’s common stock on the date of issuance.

Employee Stock Purchase Plan

Employees may elect to participate in the Company’s stockholder-approved employee stock purchase plan. The stock purchase plan allows for the purchase of the Company’s common stock at not less than 85% of the lesser of (i) the fair market value of a share of common stock on the beginning date of the offering period and (ii) the fair market value of a share of common stock on the purchase date of the offering period, subject to a share and dollar limit as defined in the plan and subject to the applicable legal requirements. There are two six-month offering periods during each fiscal year, ending on January 31 and July 31.

In accordance with applicable accounting guidance, the fair value of awards under the stock purchase plan is calculated at the beginning of each offering period. The Company estimates the fair value of the awards using the Black-Scholes option valuation model. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and the offering period. This fair value is then amortized at the beginning of the offering period. Stock-based compensation expense is based on awards expected to be purchased at the beginning of the offering period, and therefore is reduced when participants withdraw during the offering period.

Leases

The Company determines if an arrangement is a lease at inception. Operating lease ROU assets represent the Company’s right to use an underlying asset during the lease term, and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating leases are included in ROU assets, current operating lease liabilities, and long-term operating lease liabilities on the Company’s condensed consolidated balance sheets.

Lease ROU assets and lease liabilities are initially recognized based on the present value of the future minimum lease payments over the lease term at commencement date calculated using the Company’s incremental borrowing rate applicable to the lease asset, unless the implicit rate is readily determinable. ROU assets also include any lease payments made at or before lease commencement and exclude any lease incentives received. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Leases with a term of 12 months or less are not recognized on the condensed consolidated balance sheets. The Company’s leases do not contain any residual value guarantees. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company accounts for lease and non-lease components as a single lease component for all its leases.

Foreign Currency Translation

The Company uses the U.S. Dollar as the reporting currency for its financial statements. Functional currency is the currency of the primary economic environment in which an entity operates. The functional currency of the Company’s wholly owned subsidiary is the Australian dollar.

Assets and liabilities of the Company’s subsidiary are translated into U.S. Dollars at period-end foreign exchange rates, and revenues and expenses are translated at average rates prevailing throughout the period. Translation adjustments are included in “Accumulated other comprehensive income” as a separate component of stockholders’ equity, and in the “Effect of exchange rate changes on cash and cash equivalents,” on the Company’s condensed consolidated statements of cash flows. Transaction gains and losses including intercompany transactions denominated in a currency other than the functional currency of the entity involved are included in “Foreign currency exchange gain (loss), net” on the Company’s condensed consolidated statements of operations.

Accumulated Other Comprehensive Income (Loss)

Accumulated other comprehensive income (loss) includes foreign currency translation adjustments related to the Company’s subsidiary in Australia and is excluded from the accompanying condensed consolidated statements of operations.

Australia Research and Development Tax Credit

The Company’s wholly-owned Australian subsidiary incurs research and development expenses, primarily in the course of conducting clinical trials. The Company’s Australian research and development activities qualify for the Australian government’s tax credit program, which provides a 43.5% credit for qualifying research and development expenses. The tax credit does not depend on the Company’s generation of future taxable income or ongoing tax status or position. Accordingly, the credit is not considered an element of income tax accounting under ASC 740 “Income Taxes” and is recorded against qualifying research and development expenses.

The CARES Act

On March 27, 2020, the president signed into law the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) providing nearly $2 trillion in economic relief to eligible businesses impacted by the coronavirus outbreak. The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer social security payments, net operating loss (“NOL”) utilization and carryback periods, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. In addition to the loan under the Paycheck Protection Program (the “PPP”) under the CARES Act received in April 2020 (see Note 5), the Company continues to review, and intends to seek, any other available potential benefits under the CARES Act as well as any future legislation signed into law during 2022. Other than the forgiveness of the PPP loan, the effects of the CARES Act did not have a significant impact on the Company’s condensed consolidated financial statements during the three and nine months ended April 30, 2022 and 2021.

Recent Accounting Pronouncements

No recent accounting pronouncements are anticipated to have an impact on or related to the Company’s financial condition, results of operations, or related disclosures.

Note 3—Going Concern and Management’s Plans

The Company has sustained losses in all reporting periods since inception, with an accumulated deficit of approximately $277.7 million as of April 30, 2022. These losses are expected to continue for an extended period of time. Further, the Company has never generated any cash from its operations and does not expect to generate such cash in the near term. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern within one year from the issuance date of the condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern within one year after the date the condensed consolidated financial statements are issued.

As of June 1, 2022, the Company had cash and cash equivalents of $17.3 million. Since inception, cash flows from financing activities have been the primary source of the Company’s liquidity. Based on the Company’s current cash levels, the Company believes its cash resources are insufficient to meet the Company’s anticipated needs for the 12 months following the date the condensed consolidated financial statements are issued.

The Company recognizes it will need to raise additional capital to continue operating its business and fund its planned operations, including research and development, clinical trials and, if regulatory approval is obtained, commercialization of its product candidates. In addition, the Company will require additional financing if it desires to in-license or acquire new assets, research and develop new compounds or new technologies and pursue related patent protection, or obtain any other intellectual property rights or other assets. There is no assurance that additional financing will be available to the Company when needed, that management will be able to obtain financing on terms acceptable to the Company, or whether the Company will become profitable and generate positive operating cash flow. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development programs. Similarly, if our common stock is delisted from the Nasdaq Capital Market, it may limit our ability to raise additional funds (see Note 13). The ongoing COVID-19 pandemic has also caused volatility in the global financial markets and threatened a slowdown in the global economy, which may negatively affect our ability to raise additional capital on attractive terms or at all. If the Company is unable to raise sufficient additional funds when needed, on favorable terms or at all, the Company will not be able to continue the development of its product candidates as currently planned or at all, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses or cease operations, any of which would have a significant negative impact on the Company’s prospects and financial condition.

Note 4—Balance Sheet Details

Property and Equipment

Property and equipment, net, is comprised of the following:

Schedule of Property and Equipment, Net

	April 30, 2022			July 31, 2021
Equipment and furniture	$	1,944,540		$	1,919,301
Computer software		109,242			109,242
Leasehold improvements		32,651			32,651
Construction in progress		446,367			234,409
Property and equipment, gross		2,532,800			2,295,603
Accumulated depreciation and amortization		(1,509,072	)		(1,366,782	)
Total	$	1,023,728		$	928,821

Depreciation and amortization expense recorded for the three and nine months ended April 30, 2022 was approximately $47,000 and $143,000, respectively.

Depreciation and amortization expense recorded for the three and nine months ended April 30, 2021 was approximately $47,000 and $143,000, respectively.

Intangible Assets

Intangible assets, net, is comprised of the following:

Schedule of Intangible Assets

	April 30, 2022			July 31, 2021
License	$	495,000		$	495,000
Accumulated amortization		(99,000	)		(46,588	)
Total	$	396,000		$	448,412

In November 2020, the Company licensed generator technology for use in its clinical trials and other research and development efforts. Unless earlier terminated, the term of the license agreement will remain in effect for 85 months. The Company has determined that the license has alternative future uses in research and development projects. The value of the acquired license is recorded as an intangible asset with amortization over the estimated useful life of 85 months.

Intangible asset amortization expense recorded for the three and nine months ended April 30, 2022 was approximately $17,000 and $52,000, respectively.

Intangible asset amortization expense recorded for the three and nine months ended April 30, 2021 was approximately $17,000 and $29,000, respectively.

At April 30, 2022, the estimated amortization expense by fiscal year based on the current carrying value of intangible assets is as follows:


Years ending July 31,
2022 – the remainder of the fiscal year	$	17,471
2023		69,882
2024		69,882
2025		69,882
2026		69,882
Thereafter		99,001
Total	$	396,000

Accounts Payable and Accrued Liabilities

Accounts payable and accrued liabilities are comprised of the following:

	April 30, 2022		July 31, 2021
Research and development costs	$	2,391,304	$	4,206,926
Professional services fees		664,035		1,229,040
Other		90,489		125,679
Total	$	3,145,828	$	5,561,645

Accrued Compensation

Accrued compensation is comprised of the following:

Schedule of Accrued Compensation

April 30, 2022

July 31, 2021

SEC Form 10-Q filed by OncoSec Medical Incorporated