SEC Filing - Checkmate Pharmaceuticals

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10-Q

Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM

10-Q

(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2021

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from

Commission File Number

001-39425

Checkmate Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)


Delaware		36-4813934
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

245 Main Street, 2

Floor

Cambridge, MA 02142

(617)

682-3625

(Address of principal executive offices including zip code)

Registrant’s telephone number, including area code: (617)

682-3625

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


Title of each class	Trading S ym bol	Name of each exchange on which registered
Common Stock, $0.0001 par value per share	CMPI	The Nasdaq Global 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, 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.

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

☒

As of August 11, 2021, the registrant had

21,625,891

shares of common stock, $0.0001 par value per share outstanding.

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SUMMARY OF THE MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS

•

We are a clinical-stage biopharmaceutical company with a very limited operating history. We have incurred net losses since our inception and anticipate that we will continue to incur substantial and increasing net losses in the foreseeable future. We may never achieve or sustain profitability.

•

A pandemic, epidemic, or outbreak of an infectious disease, such as the global novel coronavirus disease 2019

(“COVID-19”)

pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third-parties on whom we rely, our supply chain, our ability to raise capital, and our financial results.

•

We have never generated any revenue from product sales, and our ability to generate revenue from product sales and become profitable will depend significantly on our success in achieving a number of goals and on other factors.

•

We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our research, product development or commercialization efforts.

•

We are heavily dependent on the success of vidutolimod (formerly

CMP-001),

our only current product candidate.

•

We will not be able to commercialize vidutolimod and future product candidates if our preclinical studies do not produce successful results and our clinical trials do not demonstrate the safety and efficacy of vidutolimod and future product candidates.

•

Vidutolimod is based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product candidate development.

•

Difficulty in enrolling patients could delay or prevent clinical trials of vidutolimod and future product candidates. We may find it difficult to enroll patients in our clinical trials or any subsequent trials that we may conduct.

•

Vidutolimod is being, and future product candidates may be, evaluated in combination with third-party drugs, and we do not have control over the supply, regulatory status, or regulatory approval of such drugs.

•

We currently rely on third-party contract manufacturing organizations (“CMOs”) for the production of clinical supply of vidutolimod and may rely on CMOs for the production of commercial supply of vidutolimod, if approved. This reliance on CMOs increases the risk that we will not have sufficient quantities of such materials, product candidates, or any therapies that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts.

•

We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials. If those third parties do not perform satisfactorily, we may be unable to obtain regulatory approval for vidutolimod or any future product candidates or any approvals that may be obtained may be delayed.

•

Our collaboration agreements with any future third-parties may not be successful, which could adversely affect our ability to develop and commercialize vidutolimod or any future product candidates.

•

The regulatory approval processes of the U.S. Food and Drug Administration (the “FDA”) and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize vidutolimod and future product candidates as expected, and our ability to generate revenue may be materially impaired or eliminated.

•

Our relationships with patients and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.

•

We face significant competition, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. If competitive product candidates are shown to be safer or more effective than ours, our commercial opportunity may be reduced or eliminated.

•

If we are unable to obtain, maintain and protect our intellectual property rights for our technology and our product candidates, or if our intellectual property rights are inadequate, our competitive position could be harmed.

•

Our success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on

Form 10-Q

contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. All statements, other than statements of historical facts, contained in this Quarterly Report on

Form 10-Q,

including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements include, among other things, statements about:

•

our current expectations and anticipated results of operations;

•

the timing and the success of preclinical studies and clinical trials of vidutolimod and future product candidates, including our current Phase 2 trial for

anti-PD-1

refractory melanoma, our current randomized Phase 2/3 trial for first-line melanoma, and our current Phase 2 proof of concept study in advanced head and neck squamous cell carcinoma (“HNSCC”) and our currently anticipated Phase 2 proof of concept, multi-indication trial in cutaneous squamous cell carcinoma and Merkel cell carcinoma;

•

the initiation and completion of any clinical trials of vidutolimod and future product candidates;

•

the ongoing impact of the

COVID-19

pandemic on our business;

•

our need to raise additional funding before we can expect to generate any revenues from product sales and our ability to raise capital, including in light of the impact of the

COVID-19

global pandemic and the related potential impact on the US and global economies;

•

our ability to conduct successful clinical trials or obtain regulatory approval for vidutolimod or any future product candidates that we may identify or develop;

•

our ability to ensure adequate supply of vidutolimod and any future candidates;

•

our ability to maintain third-party relationships necessary to conduct our business;

•

our dependence upon the success of our research to generate and advance additional product candidates;

•

our ability to establish an adequate safety and efficacy profile for vidutolimod or any future product candidates that we may pursue;

•

the implementation of our strategic plans for our business, vidutolimod and any other product candidates we may develop and our technology;

•

our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

•

the rate and degree of market acceptance and clinical utility for vidutolimod and any other product candidates we may develop;

•

our estimates about the size of our market opportunity;

•

our ability to maintain and establish collaborations and strategic relationships, including our clinical trial collaborations with an affiliate of Merck KGaA (“Merck”), Pfizer Inc. (“Pfizer”), Bristol-Myers Squibb Company (“BMS”), and Regeneron Pharmaceuticals, Inc. (“Regeneron”);

•

the potential benefits of the continued research, development, testing and manufacturing services provided by contract manufacturing organizations;

•

our financial performance and liquidity;

•

our ability to effectively manage our anticipated growth;

•

developments relating to our competitors and our industry, including the impact of government regulation;

•

our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;

•

our ability to maintain adequate internal controls over financial reporting;

•

our expectations regarding the period during which we qualify as an “emerging growth company” under the Jumpstart Our Business Startups Act (the “JOBS Act”);

•

our expectations regarding the period during which we qualify as a “smaller reporting company”;

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•

our use of proceeds from our initial public offering and our expectations regarding our estimated expenses, the sufficiency of our cash resources, our expected cash runway and our need for additional financing, and

•

other risks and uncertainties, including those listed under the section titled “Risk Factors.”

The forward-looking statements in this Quarterly Report on Form

10-Q

represent our views as of the date of this Quarterly Report on Form

10-Q.

We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report on Form

10-Q.

We may from

time-to-time

provide estimates, projections and other information concerning our industry, our business and the markets for our product candidate or future product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from our own internal estimates and research as well as from reports, research surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. These estimates involve numerous assumptions, are subject to risks and uncertainties and are subject to change based on various factors.

Table of Contents

CHECKMATE PHARMACEUTICS, INC.

QUARTERLY REPORT ON FORM

10-Q

FOR THE QUARTER ENDED JUNE 30, 2021

TABLE OF CONTENTS


PART I. – FINANCIAL INFORMATION			5

	Item 1.	Condensed Consolidated Financial Statements	5

		Condensed Consolidated Balance Sheets (Unaudited) as of June 30, 2021 and December 31, 2020	5

		Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Six Months Ended June 30, 2021 and 2020	6

		Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) (Unaudited) for the Three and Six Months Ended June 30, 2021 and 2020	7

		Condensed Consolidated Statements of Cash Flows (Unaudited) for the Six Months Ended June 30, 2021 and 2020	8

		Notes to Unaudited Condensed Consolidated Financial Statements	9

	Item 2.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	16

	Item 3.	Quantitative and Qualitative Disclosures About Market Risk	24

	Item 4.	Controls and Procedures	25

	PART II. – OTHER INFORMATION		25

	Item 1.	Legal Proceedings	25

	Item 1A.	Risk Factors	25

	Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	74

	Item 3.	Defaults Upon Senior Securities	75

	Item 4.	Mine Safety Disclosures	75

	Item 5.	Other Information	75

	Item 6.	Exhibits	76

	SIGNATURES		77

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PART I. – FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements

CHECKMATE PHARMACEUTICALS, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

(Unaudited)


	June 30, 2021			December 31, 2020
Assets
Current Assets:
Cash and cash equivalents	$	63,110		$	43,055
Restricted cash		20			20
Short-term investments		22,240			51,831
Prepaid expenses and other current assets		5,704			7,195

Total current assets		91,074			102,101

Investments, non-current		10,240			30,973
Machinery and equipment, net		367			—

Total assets	$	101,681		$	133,074

Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable	$	2,198		$	2,297
Accrued expenses		4,504			5,578

Total current liabilities		6,702			7,875

Total liabilities		6,702			7,875

Commitments and Contingencies (Note 9)
Stockholders’ Equity:
Preferred stock, $0.0001 par value, 10,000,000 shares authorized as of June 30, 2021 and December 31, 2020; no shares outstanding as of June 30, 2021 and December 31, 2020		—			—
Common stock, $0.0001 par value; 300,000,000 authorized as of June 30, 2021 and December 31, 2020; 21,625,891 and 21,560,398 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively		2			2
Additional paid-in capital		268,179			265,342
Accumulated other comprehensive gain (loss)		(33	)		(74	)
Accumulated deficit		(173,169	)		(140,071	)

Total stockholders’ equity		94,979			125,199

Total liabilities and stockholders’ equity	$	101,681		$	133,074

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

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CHECKMATE PHARMACEUTICALS, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

(Unaudited)


	Three Months Ended June 30,						Six Months Ended June 30,
	2021			2020			2021			2020
Operating expenses:
Research and development	$	14,865		$	6,476		$	25,243		$	12,789
General and administrative		4,090			1,795			7,893			3,305

Total operating expenses		18,955			8,271			33,136			16,094

Loss from operations		(18,955	)		(8,271	)		(33,136	)		(16,094	)

Other income (expense), net:
Interest income		20			6			73			28
Loss on sale of available-for-sale investments		(35	)		—			(35	)		—
Change in fair value of convertible loan notes		—			(83	)		—			(83	)

Total other income (expense), net		(15	)		(77	)		38			(55	)

Net loss	$	(18,970	)	$	(8,348	)	$	(33,098	)	$	(16,149	)

Reconciliation of net loss attributable to common stockholders:
Net loss	$	(18,970	)	$	(8,348	)	$	(33,098	)	$	(16,149	)
Accretion of issuance costs on redeemable convertible preferred stock		—			(429	)		—			(456	)
Accrued dividends on redeemable convertible preferred stock		—			(2,187	)		—			(3,957	)

Net loss attributable to common stockholders	$	(18,970	)	$	(10,964	)	$	(33,098	)	$	(20,562	)

Weighted-average common shares outstanding—basic and diluted		21,624,568			1,488,489			21,603,563			1,488,489

Net loss per share attributable to common stockholders—basic and diluted	$	( 0.88	)	$	(7.37	)	$	(1.53	)	$	(13.81	)



Comprehensive loss:
Net los s	$	(18,970	)	$	(8,348	)	$	(33,098	)	$	(16,149	)
Unrealized gain on available-for-sale investments		50			—			41			—
Comprehensive loss	$	(18,920	)	$	(8,348	)	$	(33,057	)	$	(16,149	)

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

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CHECKMATE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

(In thousands, except share and per share amounts)

(Unaudited)


	Series A Redeemable Convertible Preferred Stock				Series B Redeemable Convertible Preferred Stock				Series C Redeemable Convertible Preferred Stock				Common Stock				Additional Paid-In Capital		Accumulated Deficit			Accumulated Other Comprehensive Gain/(Loss)			Total Stockholders’ Equity (Deficit)
	Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Additional Paid-In Capital		Accumulated Deficit			Accumulated Other Comprehensive Gain/(Loss)			Total Stockholders’ Equity (Deficit)
Balances at December 31, 2020		—	$	—		—	$	—		—	$	—		21,560,398	$	2	$	265,342	$	(140,071	)	$	(74	)	$	125,199
Exercise of stock options		—		—		—		—		—		—		59,225		—		118		—			—			118
Stock-based compensation expense		—		—		—		—		—		—		—		—		1,216					—			1,216
Unrealized losses on available-for-sale investments		—		—		—		—		—		—		—		—		—		—			(9	)		(9	)
Net loss		—		—		—		—		—		—		—		—		—		(14,128	)		—			(14,128	)

Balances at March 31, 2021		—		—		—		—		—		—		21,619,623		2		266,676		(154,199	)		(83	)		112,396
Exercise of stock options		—		—		—		—		—		—		6,268		—		16		—			—			16
Stock-based compensation expense		—		—		—		—		—		—		—		—		1,487		—			—			1,487
Unrealized gains on available-for- sale investments		—		—		—		—		—		—		—		—		—		—			50			50
Net loss		—		—		—		—		—		—		—		—		—		(18,970	)		—			(18,970	)

Balances at June 30, 2021		—	$	—		—	$	—		—	$	—		21,625,891	$	2	$	268,179	$	(173,169	)	$	(33	)	$	94,979


	Series A Redeemable Convertible Preferred Stock				Series B Redeemable Convertible Preferred Stock				Series C Redeemable Convertible Preferred Stock				Common Stock				Additional Paid - In			Accumulated			Accumulated Other Comprehensive		Total Stockholders’
	Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Capital			Deficit			Gain/(Loss)		Equity (Deficit)

Balances at December 31, 2019		25,000,000	$	32,482		26,283,386	$	64,446		—	$	—		1,488,489	$	1	$	—		$	(97,437	)	$	—	$	(97,436	)
Issuance of series B redeemable convertible preferred stock at $2.1687 per share, net of issuance costs of $27		—		—		3,688,898		7,973		—		—		—		—		—			—			—		—
Exercise of series B preferred stock tranche right		—		—		—		300		—		—		—		—		—			—			—		—
Accretion of issuance costs related to redeemable convertible preferred stock		—		—		—		27		—		—		—		—		—			( 27	)		—		( 27	)
Stock-based compensation expense		—		—		—		—		—		—		—		—		101			—			—		101
Accrued dividends on redeemable convertible preferred stock		—		498		—		1,272		—		—		—		—		(101	)		(1,669	)		—		(1,770	)
Net loss		—		—		—		—		—		—		—		—		—			(7,801	)		—		(7,801	)

Balances at March 31, 2020		25,000,000		32,980		29,972,284		74,018		—		—		1,488,489		1		—			(106,934	)		—		(106,933	)
I ssuance of series C redeemable convertible preferred stock at $1.6016 per share, net of issuance costs of $429		—		—		—		—		46,828,167		74,571		—		—		—			—			—		—
Conversion of convertible notes into series C convertible redeemable preferred stock		—		—		—		—		6,295,756		10,083		—		—		—			—			—		—
Accretion of issuance costs related to redeemable convertible preferred stock		—		—		—		—		—		429		—		—		—			(429	)		—		(429	)
Stock-based compensation expense		—		—		—		—		—		—		—		—		100			—			—		100
Accrued dividends on redeemable convertible preferred stock		—		499		—		1,296		—		392		—		—		(100	)		(2,087	)		—		(2,187	)
Net loss		—		—		—		—		—		—		—		—		—			(8,348	)		—		(8,348	)

Balances at June 30, 2020		25,000,000	$	33,479		29,972,284	$	75,314		53,123,923	$	85,475		1,488,489	$	1	$	—		$	(117,798	)	$	—	$	(117,797	)

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

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CHECKMATE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)


	Six Months Ended June 30,
	2021			2020
Cash flows from operating activities
Net loss	$	(33,098	)	$	(16,149	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock based compensation		2,703			201
Depreciation		11			—
Change in fair value of notes payable		—			83
Amortization/accretion of investments		370			—
Change in operating assets and liabilities:
Prepaid expenses and other current assets		1,491			(610	)
Accounts payable		(98	)		(31	)
Accrued expenses		(1,075	)		464

Net cash used in operating activities		(29,696	)		(16,042	)

Cash flows from investing activities
Purchases of investments		(10,197	)		—
Maturities of investments		29,500			—
Sale of investments		30,692			—
Purchase of machinery and equipment		(378	)		—

Net cash provided by investing activities		49,617			—
Cash flows from financing activities
Proceeds from stock option exercises		134			—
Cash paid for initial public offering costs		—			(398	)
Proceeds from issuance of convertible preferred stock, net of issuance costs		—			82,544
Proceeds from issuance of convertible loan notes		—			10,000

Net cash provided by financing activities		134			92,146

Net increase in cash, cash equivalents and restricted cash		20,055			76,104
Cash, cash equivalents and restricted cash at beginning of period		43,075			4,205

Cash, cash equivalents and restricted cash at end of period	$	63,130		$	80,309

Supplemental disclosure of non-cash financing activities:
Accretion of issuance costs to redeemable convertible preferred stock	$	—		$	456
Exercise of Series B preferred stock tranche right	$	—		$	300
Accrued dividends on redeemable convertible preferred stock	$	—		$	3,957
Conversion of loan notes into series C preferred stock	$	—		$	10,083
Deferred offering costs included in prepaid expenses and other current assets and accounts payable or accrued expenses	$	—		$	1,217

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

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CHECKMATE PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1 – N

ATURE

USINESS

Nature of Business

Checkmate

Pharmaceuticals

, Inc. (“Checkmate” or the “Company”), headquartered in Cambridge, Massachusetts, is a clinical stage biotechnology company incorporated under the laws of the State of Delaware in July 2015 that is focused on developing and commercializing its proprietary technology to harness the power of the immune system to combat canc

r. Since its inception, the Company has devoted substantially all of its efforts to the research and development activities, including recruiting management and technical staff, raising capital, producing materials for

non-clinical

and clinical studies and building infrastructure to support such activities, and has not yet generated any revenue. Expenses have primarily been for research and development and related administrative costs. The Company has financed its operations through the sale of common stock, convertible debt and redeemable convertible preferred stock.

Initial Public Offering

On August 11, 2020, the Company closed its initial public offering (“IPO”), at which time the Company issued and sold 5,000,000 shares of its common stock, at a price to the public of $15.00 per share. On September 3, 2020, the underwriters of the IPO exercised a portion of their overallotment option by purchasing an additional 109,861 shares from the Company at the IPO price. The Company received approximately $67.7 million in net proceeds, inclusive of the over-allotment exercise and after deducting underwriting discounts and commissions and other offering expenses payable by the Compan

connection with the closing of the IPO, all outstanding shares of the Company’s preferred stock were converted into 14,948,241 shares of the Company’s common stock.

On July 31, 2020, the Company effected a

one-for-7.4771

reverse stock split of its common stock. All shares, stock options, warrants, redeemable convertible preferred stock conversion prices, ratios and per share information presented in the condensed consolidated financial statements have been adjusted to reflect the reverse stock split on a retroactive basis for all periods presented. The par value per share and the authorized number of shares of common stock were not adjusted as a result of the reverse stock split.

Risks and Uncertainties

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, the outcome of clinical trials, development by competitors of new therapeutics and technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, ability to secure additional capital to fund operations, and risks associated with the ongoing

COVID-19

global pandemic or future pandemics, including known and potential delays associated with its ongoing and anticipated trials and the Company’s ability to raise additional capital to finance its operations. There can be no assurance that the Company will be able to successfully complete the development of, or receive regulatory approval for, any products developed, and if approved, that any products will be commercially viable. Any products resulting from the Company’s current research and development efforts will require significant additional research and development, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts will require significant amounts of additional capital, adequate personnel, infrastructure and extensive compliance reporting capabilities. The Company has not generated any revenues from the sale of any products to date. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

The Company may seek additional funding through private or public equity financings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing agreements. If the Company is unable to obtain additional funding, the Company may be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these

plans

, there is no assurance that the Company

will

be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all.

The Company expects that its cash, cash equivalents and

available-for-sale

investments of $95.6

million as of June 30, 2021 will be sufficient to fund its operating expenses and capital requirements for at least 12 months beyond the date of issuance of these condensed consolidated financial statements.

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2 – S

UMMARY

IGNIFICANT

CCOUNTING

OLICIES

The Company’s significant accounting policies are described in Note 2,

Summary of Significant Accounting Policies

, to the financial statements for the year ended December 31, 2020 in the Company’s 2020 Annual Report on Form

10-K.

There have been no material changes to the significant accounting policies during the

six-month

period ended June 30, 2021, except as noted below.

Basis of Presentation

The accompanying condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and include the accounts of the Company and its wholly owned subsidiary Checkmate Pharmaceuticals Security Corporation. Any reference in these notes to applicable guidance is meant to refer to the authoritative accounting principles generally accepted in the United States as found in the Accounting Standard Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB).

Unaudited interim financial information

The accompanying interim condensed consolidated financial statements and related disclosures are unaudited and have been prepared in accordance with GAAP for interim financial information and the instructions to Form

10-Q

and Article 10 of Regulation

S-X

of the Exchange Act. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s financial statements and related footnotes as of and for the year ended December 31, 2020, included in the Company’s 2020 Annual Report on Form

10-K.

The Company’s financial information as of June 30, 2021, and for the three and six months ended June 30, 2021 and 2020 is unaudited, but in the opinion of management, includes all adjustments, consisting only of normal recurring adjustments, considered necessary for a fair presentation of the financial position, results of operations and cash flows at the dates and for the periods presented. The balance sheet data as of December 31, 2020 was derived from audited financial statements. The results of the Company’s operations for any interim period are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year.

Use of estimates

The preparation of the Company’s condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual of research and development expenses and the valuation of stock-based awards before the Company’s IPO. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions.

Machinery and equipment

Machinery and equipment is recorded at cost less accumulated depreciation. Depreciation is recognized using the straight-line method over the estimated useful life of five years for each asset. Accumulated depreciation at June 30, 2021 was $11,000.

Recently issued accounting pronouncement

In June 2016, the FASB issued ASU

2016-13,

“Credit Losses (Topic 326).” ASU

2016-13

requires that financial assets measured at amortized cost, such as trade receivables and investments, be represented net of expected credit losses, which may be estimated based on relevant information such as historical experience, current conditions, and future expectation for each pool of similar financial asset. The new guidance requires enhanced disclosures related to trade receivables and associated credit losses. In May 2019, the FASB issued ASU

No. 2019-05,

“Financial Instruments—Credit Losses (Topic 326) Targeted Transition Relief,” which allows for a transition election on certain instruments. The guidance is effective for Smaller Reporting Companies for fiscal years beginning after December 15, 2022 and interim periods in those fiscal years. In November 2019, the FASB issued ASU

No. 2019-11

which amends certain aspects of ASU

No. 2016-13,

including transition relief for trouble debt restructuring, among other topics. The Company is currently evaluating the impact of this pronouncement on its consolidated financial statements.

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3 – I

NVESTMENTS

AND

AIR

ALUE

EASUREMENT

he following tables summarizes the amortized cost and estimated fair value of the Company’s investments, which are considered to be

available-for-sale

investments as of June 30, 2021 and December 31, 2020.

As of June 30, 2021



	Amortized Cost		Unrealized Gains		Unrealized Losses			Fair Value		Short-term Investments		Investments, non-current
					(in thousands)

Commercial paper	$	2,991	$	—	$	—		$	2,991	$	2,991	$	—
Corporate debt securities		29,522		—		(33	)		29,489		19,249		10,240

Total	$	32,513	$	—	$	(33	)	$	32,480	$	22,240	$	10,240

As of December

31, 2020

	Amortized Cost		Unrealized Gains		Unrealized Losses			Fair Value		Short-term Investments		Investments, non-current
					(in thousands)

Commercial paper	$	42,709	$	8	$	(16	)	$	42,701	$	42,701	$	—
Corporate debt securities		41,169		—		(66	)		41,103		10,130		30,973

Total	$	83,878	$	8	$	(82	)	$	83,804	$	52,831	$	30,973

The amortized cost and estimated fair value of investments by contractual maturity at June 30, 2021 are as follows:


			Estimated
	Amortized		Fair
	Cost		Value
	(in thousands)

Due in one year or less	$	22,258	$	22,240
Due after one year through two years		10,255		10,240

	$	32,513	$	32,480

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At June 30, 2021

there

were no available-for-sale

securities in the Company’s total investment portfolio that were in a continuous unrealized loss position for more than 12 m

nths. The Company concluded that the net declines in market value of

available-for-sale

securities were temporary in nature and did not consider any of investments to be other-than-temporarily impaired.

The following tables set forth the fair value of the Company’s financial assets and liabilities by level within the fair value hierarchy that are measured at fair value on a recurring basis:


	June 30, 2021
	Level 1		Level 2		Level 3		Total
	(in thousands)
Assets:
Money markets funds (included in cash equivalents)	$	61,907	$	—	$	—	$	61,907
Commercial paper		—		2,991		—		2,991
Corporate debt securities		—		29,489		—		29,489

Total assets	$	61,907	$	32,480	$	—	$	94,387


	December 31, 2020
	Level 1		Level 2		Level 3		Total
	(in thousands)
Assets:
Money markets funds (included in cash equivalents)	$	7,839	$	—	$	—	$	7,839
Commercial paper		—		42,701		—		42,701
Corporate debt securities		—		41,103		—		41,103

Total assets	$	7,839	$	83,804	$	—	$	91,643

Investments classified as Level 2 within the valuation hierarchy consist of commercial paper and corporate debt securities. The Company estimates the fair values of these marketable securities by taking into consideration valuations obtained from third-party pricing sources.

4 – A

CCRUED

XPENSES

Accrued expenses consist of the following:


	June 30,		December 31,
	2021		2020
	(in thousands)
Payroll and employee related expenses	$	1,677	$	1,555
External research and development		2,077		3,633
Other accrued expenses		750		390

Total accrued expenses	$	4,504	$	5,578

5 – R

EDEEMABLE

ONVERTIBLE

REFERRED

TOCK

On August 11, 2020, in connection with the closing of the IPO, all outstanding shares of the Company’s preferred stock were converted into 14,948,241 shares of common stock. As a r

sult of the conversion, the Company reclassified the carrying value of its preferred stock, which included all cumulative but unpaid dividends, to common stock and additional

paid-in-capital

and therefore there was no outstanding redeemable convertible preferred stock as of June 30, 2021 and December 31, 2020.

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6 – E

QUITY

The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders. Common stockholders are entitled to receive dividends declared out of funds legally available, subject to the payment in full of all preferential dividends to which the holders of preferred stock are entitled.

On August 11, 2020, the Company fil

d a restated certificate of incorporation in the State of Delaware, which, among other things, restated the number of shares of all classes of stock that the Company has authority to issue up to 310,000,000 shares, consisting of (i) 300,000,000 shares of common stock, $0.0001 par value per share, and (ii) 10,000,000 shares of preferred stock, $0.0001 par value per share. The shares of preferred stock are currently undesignated and no shares are outstanding.

Also on August 11, 2020, the Company completed its IPO, pursuant to which it issued and sold 5,109,861 shares of common stock, inclusive of 109,861 shares sold by the Company pursuant to the full exercise of the underwriters’ option to purchase additional shares. The aggregate net proceeds received by the Company from the IPO were $67.7 million, after deducting underwriting discounts and commissions and other offering costs

7 – S

TOCK

-B

ASED

OMPENSATION

Total stock-based compensation expense was classified in the accompanying condensed consolidated statements of operations and comprehensive loss as follows:


	Three Months Ended June 30,				Six Months Ended June 30,
	2021		2020		2021		2020
	(in thousands)				(in thousands)
Research and development	$	608	$	39	$	1,094	$	78
General and administrative		879		61		1,609		123

Total stock-based compensation expense	$	1,487	$	100	$	2,703	$	201

During the six months ended June 30, 2021, the Company granted options with service-based vesting conditions for the purchase of 862,350 shares of common stock with a weighted average exercise price of $12.70 per share and a weighted average grant-date fair value of $8.85 per share.

8 – N

OSS

HARE

Net Loss Per Share Attributable To Common Stockholders

Because the Company reports a net loss attributable to common stockholders, basic and diluted net loss per share attributable to common stockholders are the same for both years presented. All preferred stock and stock options have been excluded from the computation of diluted weighted-average shares outstanding because such securities would have an antidilutive impact. The following common stock equivalents outstanding at June 30, 2021 and 2020 have been excluded from the calculation of diluted net loss per share because their inclusion would have been antidilutive:


	June 30,
	2021		2020
Options to purchase common stock		3,284,323		1,073,044
Redeemable convertible preferred stock		—		14,948,249

9 – C

OMMITMENTS

AND

ONTINGENCIES

Operating Lease

The Company has a

month-to-month

lease agreement for its corporate space in Cambridge, Massachusetts. Rent expense is recognized as incurred. Rent expense for the three months ended June 30, 2021 and 2020 was $0.2 million and $0.1 million, respectively. Rent expense for each of the six months ended June 30, 2021 and 2020 was $0.3 million.

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Clinical Trial Collaboration and Supply Agreements

On May 10, 2021, the Company entered into a Supply and

Non-Exclusive

License Agreement (“SNLA”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”). The SNLA dictates the general terms that govern specific collaborative studies between the Company and Regeneron, including a Phase 2 proof of concept trial, with patient cohorts in

anti-PD-1

naïve and

anti-PD-1

refractory cutaneous squamous cell carcinoma

and anti-PD-1

refractory Merkel cell carcinoma. Pursuant to the SNLA, Regeneron agreed to provide cemiplimab, a drug to be used concurrently or in combination with vidutolimod in the aforementioned studies, at its own expense. As part of the SNLA, the parties granted each other

non-exclusive

licenses to use background intellectual property and regulatory documentation to seek regulatory approval of the other party’s compound solely for use as a combination therapy. The Company does not expect any future consideration to be payable to Regeneron pursuant to the SNLA.

On December 7, 2020, the Company entered into the Master Clinical Trial Collaboration Agreement (“MCTCA”) with Bristol-Myers Squibb Company (“BMS”). The MCTCA dictates the general terms that govern specific collaborative studies between the companies, including the Company’s Phase 2 refractory melanoma study and Phase 2 front-line melanoma study (collectively, the “collaborative studies”). Pursuant to the MCTCA, BMS agreed to provide nivolumab, a drug to be used in combination with vidutolimod in the collaborative studies, at its own expense. As part of the MCTCA, the parties granted each other

non-exclusive

licenses to use background intellectual property and regulatory documentation to seek regulatory approval of the other party’s compound solely for use as a combination therapy. The Company does not expect any further consideration to be payable to BMS pursuant to the MCTCA.

On August 22, 2018, the Company entered into the Clinical Trial Collaboration and Supply Agreement (“CTCSA”) with an affiliate of Merck KGaA (“Merck”) and Pfizer Inc. (“Pfizer”) (Merck and Pfizer together are referred to herein as the “Alliance”). Pursuant to the CTCSA, the Company, and the Alliance will each provide compound drug product that will be dosed concurrently or in combination in a clinical trial sponsored by Pfizer. This agreement was amended on March 4, 2019. In addition to providing a compound drug product to be used in the clinical trial, the Company will reimburse Pfizer for each patient dosed in the study using the Company’s compound at a specified rate outlined in the CTCSA. In no event will the amount of costs due by the Company to Pfizer exceed $4.0 million over the term of the CTCSA. The costs of services performed, and material used in connection with the research and development activities of the CTCSA, including reimbursements due to Pfizer, are included in research and development costs and expensed as incurred. The Company incurred $1.0 million and $0.5 million of expense during the years ended December 31, 2020 and 2019, respectively. By mutual agreement of the Company and the Alliance, the clinical trial was discontinued in 2020, and the Company does not expect to incur any further costs in connection with the CTCS

License Agreement

In June 2015, the Company entered into an exclusive license agreement with Cytos Biotechnology LTD (now Kuros Biosciences AG, or “Kuros”) as amended in August 2017 and as further amended in January 2018 (the “Kuros License Agreement”). Pursuant to the Kuros License Agreement, in return for payments made, the Company was granted an exclusive, royalty-bearing, sublicensable, worldwide license, under all of Kuro’s intellectual property rights, including any intellectual property rights arising during the term of the agreement, to commercially develop, manufacture, use, distribute, and sell certain therapeutic products, including vidutolimod, (the “Licensed Products”) for the diagnosis, treatment and prevention of all indications in humans and animals. Under the terms of the Kuros License Agreement, the Company is required to use commercially reasonable efforts to develop at least one Licensed Product. Under the Kuros License Agreement, the Company agreed to make payments to Kuros for each product that achieves certain development and regulatory milestones, including payments of up to $56.0 million for the Company’s current oncology programs. As of June 30, 2021, the Company has incurred license fees and milestone payments totaling $8.3 million pursuant to the Kuros License Agreement. These payments are comprised of: (i) a license fee of $1.0 million which was recognized in research and development expense in 2015, (ii) a $1.0 million milestone payment in connection with the dosing of the first patient in our first Phase 1 clinical trial, which was recognized in research and development expense in 2016, (iii) a $0.3 million license amendment fee in connection with the signing of the second amendment to the Kuros License Agreement, which was recognized in research and development expense in 2018, (iv) a $2.0 million milestone payment in connection with the dosing of the first patient in the Phase 2 first-line melanoma trial for vidutolimod, which was recognized in the statement of operations for the three months ended March 31, 2021 and (v) a $4.0 million milestone payment in connection with the dosing in a Phase 2 trial intended to assess the efficacy and safety of vidutolimod in combination with nivolumab for the treatment of patients with

anti-PD-1

refractory melanoma and to potentially support a Biologics License Application (“BLA”) and marketing approval of vidutolimod, which was recognized in the consolidated statements of operations for the three months ended June 30, 2021.

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The Company is also required to pay tiered royalties of high single-digit to low teens percentages on annual net sales of Licensed Products that are covered by a licensed patent, as well as royalties at 50% of the foregoing amounts with respect to sales of Licensed Products that are not covered by a licensed patent, but are covered by

licensed know-how.

The Kuros License Agreement expires upon the expiration of

the last-to-expire royalty

term for the Licensed Products in the territory. Either party has the right to terminate the agreement in full for an uncured material breach of the agreement upon written 60 days’ notice to the other party. The Company has the right to terminate the agreement for any reason upon 90

days’ written notice to Kuros.

Other Contingencies

During the ordinary course of its operations, the Company may become a party to contractual disputes, litigation, and potential claims. The Company does not believe that the resolution of any of these matters, if any, will have a material adverse effect on its financial position or results of operations

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Item 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis should be read in conjunction with the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form

10-Q

and our audited financial statements and related notes thereto for the year ended December 31, 2020 included in our 2020 Annual Report on Form

10-K. This

discussion and analysis and other parts of this Quarterly Report on Form

10-Q

contain forward-looking statements based upon current beliefs, plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth in the “Risk Factors” section of this Quarterly Report on Form

10-Q

and in other filings with the SEC. Please also see the section entitled “Note Regarding Forward-Looking Statements” contained in the Quarterly Report on Form

10-Q.

Overview

We are a clinical-stage biotechnology company focused on developing and commercializing our proprietary technology to harness the power of the immune system to combat cancer. Our product candidate, vidutolimod (formerly

CMP-001),

is a differentiated Toll-like receptor 9 (“TLR9”), agonist delivered as a biologic virus-like particle (“VLP”), utilizing a

CpG-A

oligonucleotide as a key component. When injected into a tumor, vidutolimod is designed to trigger the body’s innate immune system, thereby altering the tumor microenvironment and directing activated anti-tumor T cells to attack both the injected tumor and also tumors throughout the body. In a clinical trial of vidutolimod in combination with a systemic checkpoint inhibitor (“CPI”), in patients whose tumors were unresponsive or no longer responsive to a CPI, we have observed a best objective response rate (“ORR”), of 28% (27/98), including post-progression responders. We are evaluating vidutolimod across multiple tumor types in combination with other immunotherapy agents. Our founder, Art Krieg, first reported the discovery of immunostimulatory cytosine-phosphate-guanine (“CpG”), DNA in 1995, which, combined with the discovery of TLR9, led to the recognition that synthetic

CpG-A

oligonucleotides have the potential to stimulate the TLR9 receptor for therapeutic purposes. Our goal is to establish vidutolimod as a foundational immuno-oncology therapy that engages the innate immune system to fight cancer and improve outcomes for patients with a broad range of solid tumors.

Since our inception, we have devoted substantially all of our efforts and financial resources to the research and development activities related to our technology and our vidutolimod program, and the administrative support for such activities including raising capital, business planning, undertaking

pre-clinical

studies and clinical trials and other support activities. We do not have any products approved for sale and have not generated any revenue from product sales or any other sources and do not expect to generate any revenue for the next several years. We have not yet successfully completed any registrational clinical trials, obtained any regulatory approvals, manufactured a commercial-scale drug, or conducted sales and marketing activities.

We have incurred recurring losses and had negative operating cash flows since inception and our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of vidutolimod or any other products we acquire or develop. Our net losses were $28.3 million and $36.9 million for the years ended December 31, 2019 and 2020, respectively, and for the six months ended June 30, 2021, our net loss was $33.1 million. As of June 30, 2021, we had an accumulated deficit of $173.2 million. We expect to continue to incur significant expenses and to increase operating losses for at least the next several years.

We expect our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly as we:

•

prepare for, initiate and conduct additional clinical trials and preclinical studies of vidutolimod, including, among others, our current Phase 2 trial in

anti-PD-1

refractory melanoma, our current randomized Phase 2/3 trial in first-line melanoma, our current Phase 2 proof of concept study in head and neck squamous cell carcinoma, and our currently anticipated Phase 2 proof of concept trial with patient cohorts in

anti-PD-1

naïve and

anti-PD-1

refractory cutaneous squamous cell carcinoma and Merkel cell carcinoma;

•

conduct the necessary

scale-up

activities to support the potential commercialization of vidutolimod, if approved;

•

hire additional clinical and scientific personnel to support our ongoing preclinical activities and clinical trials of vidutolimod and any other product candidates we choose to develop;

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•

develop any future product candidates;

•

seek marketing approval for vidutolimod and any other product candidates that successfully complete clinical development;

•

acquire or

in-license

additional product candidates;

•

maintain compliance with applicable regulatory requirements;

•

maintain, expand, protect and enforce our intellectual property portfolio;

•

develop and expand our sales, marketing and distribution capabilities for vidutolimod and any other product candidates for which we obtain marketing approval;

•

take precautionary measures to help minimize the risk of the coronavirus or any other future pandemic to our employees and encounter continued delays or interruptions related to current development activities, our supply chain, or the third-parties on whom we rely due to the

COVID-19

pandemic;

•

expand our infrastructure and facilities to accommodate the planned growth of our employee base; and

•

expand our operational, financial and management systems and increase administrative personnel, including to support our clinical development and commercialization efforts and our operations as a public company.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing and distribution or licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of vidutolimod or any of our future product candidates.

On August 11, 2020, we completed our initial public offering (“IPO”), pursuant to which we issued and sold 5,000,000 shares of our common stock, at a price to the public of $15.00 per share. On September 3, 2020, the underwriters of the IPO exercised a portion of their over-allotment option by purchasing an additional 109,861 shares from us at the IPO price. We received approximately $67.7 million in net proceeds, inclusive of the partial over-allotment exercise and after deducting underwriting discounts and commissions and other offering expenses payable by us. In connection with the IPO, on August 11, 2020, all redeemable convertible preferred stock was converted into shares of common stock.

Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder.

COVID-19

In March 2020 the World Health Organization declared the global novel coronavirus disease 2019

(“COVID-19”)

a pandemic. Although we have experienced some impact of the

COVID-19

pandemic on our business and operations, including delays in initiation of study sites and enrolling patients, we cannot currently predict the scope and severity of any potential business shutdowns or disruptions or the resulting impact on future clinical trials. As of the date hereof, certain of our ongoing clinical trials are nearing completion and have not been materially affected by the

COVID-19

pandemic, and the schedules for the near-term manufacture of vidutolimod at our contract manufacturers have also been largely unaffected to date. Certain of our clinical trials that commenced in 2020 were adversely affected by the

COVID-19

pandemic, resulting in patient enrollment delays in the first half of 2021. We are also in the planning stages for new clinical trials, and a number of activities are required in order to initiate patient enrollment into these trials that could be impacted by

COVID-19

as the pandemic continues to evolve.

While the

COVID-19

pandemic did not materially impact our results of operations during 2020, the ultimate impact on our operations is unknown and will depend on future developments, which, despite progress in vaccination efforts, remain uncertain and cannot be predicted with confidence, including the duration of the

COVID-19

pandemic, new strains of the virus which may impact rates of infection and vaccination efforts, developments or perceptions regarding the safety of vaccines, new information which may emerge, and any additional preventative and protective actions that governments, or we, may direct, which may result in extending ongoing business disruptions, reduced patient traffic and reduced operations. We are continuing to monitor the latest developments regarding the

COVID-19

pandemic, including the pace of vaccinations and the emergence of new and more contagious strains of the virus, and any resulting impact on our business, financial condition, results of operations and prospects. Any resulting financial impact cannot be reasonably estimated at this time and may have a material adverse impact on our business, financial condition and results of operations.

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Components of Our Results of Operations

Revenue

To date, we have not generated any revenue from any sources and do not expect to generate any revenue from the sale of products for the next several years. If our development efforts for vidutolimod or any future product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales. However, we cannot predict whether, when, or to what extent we will generate revenue from the commercialization and sale of vidutolimod or any future product candidates as we may never succeed in obtaining regulatory approval for any of our product candidates. If we enter into license or collaboration agreements for any of our product candidates or intellectual property, we may generate revenue in the future from payments as a result of such license or collaboration agreements, however there can be no assurance that we will be able to enter into any license or collaboration agreements.

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities and the development of our VLP technology and our vidutolimod program and include:

•

expenses incurred in connection with the preclinical and clinical development of our technology and vidutolimod, including clinical trials under agreements with contract research organizations (“CROs”), clinical investigators and consultants;

•

employee-related expenses, including salaries, benefits and travel and stock-based compensation expense, for employees engaged in research and development functions;

•

the cost of contract manufacturing organizations (“CMOs”), that manufacture drug product for use in our preclinical studies and clinical trials and perform analytical testing,

scale-up

and other services in connection with our development activities;

•

costs related to compliance with regulatory requirements;

•

payments made under third-party licensing agreements, such as the exclusive license agreement we entered into with Cytos Biotechnology LTD (now Kuros Biosciences AG, or “Kuros”) (the “Kuros License Agreement”);

•

facilities and other expenses, which include direct and allocated expenses for facilities, insurance and supplies; and

•

costs related to compliance with regulatory requirements.

We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers. This process involves reviewing open contracts, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. Any nonrefundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are expensed as the related goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered.

Upfront payments under license agreements are expensed upon receipt of the license, and any annual maintenance fees under license agreements are expensed in the period in which they are incurred. Milestone payments under license agreements are accrued and a corresponding expense is recognized in the period in which the milestone is determined to be probable of achievement and the related amount is reasonably estimable.

We do not track our research and development expenses by indication. Our direct external research and development expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research/testing laboratories and outside consultants in connection with our preclinical development, process development, manufacturing and clinical development activities. Our direct research and development expenses also include fees incurred under licensing agreements. We do not allocate these costs to specific indications because they are deployed across the entire the vidutolimod development program and, as such, are not separately classified. We use internal resources primarily to manage our preclinical development, outsourced clinical trials, process development, manufacturing and clinical development activities. These employees work across the entire the vidutolimod development program and, therefore, we do not track their costs by indication.

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Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will continue to increase substantially over the next several years as we advance vidutolimod into later stages of clinical development toward potential regulatory approval, advance vidutolimod for additional indications, as well as conduct translational research efforts and other preclinical and clinical development, including submitting regulatory filings for any other product candidates we may acquire or develop. In addition to the expected increase in third-party costs, we expect our personnel costs, including costs associated with stock-based compensation, will also increase substantially in the future. In addition, as we advance vidutolimod into potentially registrational clinical trials and, subject to positive data and regulatory approvals, potentially commercialize vidutolimod, we expect to incur additional expenses from milestone and royalty payments related to the Kuros License Agreement.

We do not believe that it is possible at this time to accurately project total program-specific expenses through commercialization of vidutolimod or any other product candidates we may acquire or develop. This is due to numerous factors, some of which are beyond our control, that are associated with the successful development and commercialization of vidutolimod and any other product candidates we may acquire or develop, including the following:

•

the scope, progress, outcome and costs of our preclinical studies and clinical trials for vidutolimod or any other product candidates we may acquire or develop;

•

making arrangements with third-party manufacturers for both clinical and commercial supplies of vidutolimod or any other product candidates;

•

successful patient enrollment in, and the initiation and completion of clinical trials;

•

raising additional funds necessary to complete clinical development and the potential commercialization, of vidutolimod or any other product candidates;

•

receipt, timing and related terms of marketing approvals from applicable regulatory authorities;

•

the extent of any required post-marketing approval commitments to applicable regulatory authorities;

•

developing and implementing marketing and reimbursement strategies;

•

establishing sales, marketing and distribution capabilities and launching commercial sales of vidutolimod or any other products, if approved, whether alone or in collaboration with others;

•

acceptance of vidutolimod or any other products, if approved, by patients, the medical community and third-party payors;

•

effectively competing with other therapies and/or changes in standard of care;

•

obtaining and maintaining third-party coverage and adequate reimbursement;

•

obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity for our product candidates;

•

protecting and enforcing our rights in our intellectual property portfolio;

•

significant and changing government regulations; and

•

maintaining an acceptable tolerability profile of the products following approval, if any.

A change in the outcome of any of these variables with respect to the development of vidutolimod or any future product candidates would significantly change the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval for any product candidate.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and benefits, stock-based compensation and travel expense for personnel in executive, business development, finance, human resources, legal and support functions. General and administrative expenses also include direct and allocated facility-related costs as well as insurance costs and professional fees for legal, patent, consulting, accounting and audit services, investor and public relations services and outsourced information technology services.

We anticipate that our general and administrative expenses will continue to increase in the future as we increase our headcount to support the continued advancement of vidutolimod toward potential commercialization and the future development of any other product candidates that we may pursue. We also anticipate that we will continue to experience an increase in accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company. Additionally, if we believe a regulatory approval of vidutolimod or any other product candidate appears likely, we anticipate an increase in payroll and other employee-related expenses as a result of our preparation for commercial operations to market and sell that product candidate.

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Interest Income

Interest income consists of interest earned on our cash, cash equivalent and

available-for-sale

investments balances. We expect that our interest income will fluctuate based on prevailing interest rates, our ability to raise additional funds as well as the amount of expenditures for our clinical development of vidutolimod and ongoing business operations.

Income Taxes

There were no provisions for income taxes for the three and six months ended June 30, 2021 and 2020 because we have historically incurred operating losses and we maintain a full valuation allowance against our net deferred tax assets.

Results of operations

Comparison of the three months (“Q2”) and six months (“Q2 YTD”) ended June 30, 2021 and 2020

The following table summarizes our results of operations for the three and six months ended June 30, 2021 and 2020:


	Three months ended									Six months ended
	June 30,						Increase			June 30,						Increase
	2021			2020			(Decrease)			2021			2020			(Decrease)
							(unaudited, in thousands)
Operating expenses:
Research and development	$	14,865		$	6,476		$	8,389		$	25,243		$	12,789		$	12,454
General and administrative		4,090			1,795			2,295			7,893			3,305			4,588

Total operating expenses		18,955			8,271			10,684			33,136			16,094			17,042

Loss from operations		(18,955	)		(8,271	)		10,684			(33,136	)		(16,094	)		17,042
Total other income (expense), net		(15	)		(77	)		(62	)		38			(55	)		93

Net loss	$	(18,970	)	$	(8,348	)	$	10,622		$	(33,098	)	$	(16,149	)	$	16,949

Research and Development Expenses

Research and development expenses were $14.9 million in Q2 2021 compared to $6.5 million in the same quarter of 2020. The increase of approximately $8.4 million was primarily related to the $4.0 million milestone payment due to Kuros in Q2 2021, which became payable upon initiating dosing of the first patient in a Phase 2

anti-PD-1

refractory melanoma trial for vidutolimod in May 2021. This Phase 2 trial is intended to potentially support a BLA and marketing approval of vidutolimod and therefore triggered the Phase 3 study milestone as defined under our license agreement with Kuros. Also contributing to the increase was higher clinical costs of $1.5 million associated ongoing trials, higher contract manufacturing of $2.0 million related to producing vidutolimod to meet the needs of the clinical trials, and higher personnel and consulting costs of $0.3 million as well as stock-based compensation expense of $0.6 million associated with increased staffing.

Research and development expenses were $25.2 million in Q2 YTD 2021 compared to $12.8 million for the same period of 2020, an increase of $12.5 million. The increase was due to combined milestones payments of $6.0 million to Kuros which became payable upon the Company initiating dosing of patients in trials which triggered Phase 2 and Phase 3 milestone payments. Also contributing to the increase was increased clinical trials costs of $2.6 million and outsourced contract manufacturing costs of $2.4 million related to greater activity in our ongoing clinical trials, as well as additional personnel and consulting costs of $0.7 million and stock-based compensation costs of $1.0 million associated with increased staffing.

General and Administrative Expenses

General and administrative expenses were $4.1 million in Q2 2021 compared to $1.8 million in the same quarter of 2020. The increase of $2.3 million was primarily comprised of an increase in directors and officers insurance of $0.9 million associated with being a public company in 2021, an increase is stock-based compensation expenses of $0.8 million related to stock options granted after our IPO and an increase in personnel and consulting expense of $0.2 million associated with increased staffing.

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General and administrative expenses were $7.9 million in Q2 YTD 2021 compared $3.3 million in the same period of 2020, an increase of $4.6 million. The increase was primarily due to increased directors and officers insurance of $1.7 million, increased stock-based compensation of $1.5 million and increased personnel and consulting expense of $0.6 million.

Other income (expense), net

Other income (expense), net in the three and six month periods of 2021 include interest income, which was more than offset by losses on the sale of

available-for-sale

securities in Q2 2021 and partially offset by losses on the sale of

available-for-sale

investments in Q2 YTD 2021.

Other income (expense), net in the three and six month periods of 2020 primarily reflects the change in the fair value change of the convertible loan notes we issued to certain investors in April 2020 (the “Convertible Loan Notes”) by $0.1 million, primarily related to the accrued interest earned on the Convertible Loan Notes prior to conversion upon the sale of Series C preferred stock in June 2020, slightly offset by interest income.

Liquidity and capital resources

Overview

We have funded our operations to date primarily with proceeds from the sale of preferred stock, convertible debt and common stock. Since inception and through June 30, 2021, we have received net cash proceeds of $241.7 million from sales of our preferred stock, convertible debt and common stock. In April 2020, we received $10.0 million from the issuance of Convertible Loan Notes and in June 2020, we received $74.6 million in additional net proceeds from the sale of Series C preferred stock. The Convertible Loan Notes were converted into shares of Series C preferred stock in June 2020.

As noted above, in August 2020, we completed an IPO in which we received net proceeds of approximately $67.7 million, inclusive of the partial exercise of the over-allotment exercise and after deducting underwriting discounts and commissions and other offering expenses payable by us. In connection with the IPO, all outstanding shares of our redeemable preferred stock were converted to common stock.

We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all. As of June 30, 2021, we had cash, cash equivalents and

available-for-sale

investments of $95.6 million.

We believe that the net proceeds from the IPO, together with our existing cash, cash equivalents and

available-for-sale

investments as of June 30, 2021, will enable us to fund our operating expenses and capital expenditure requirements through the end of 2022. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Our future viability beyond that point is dependent on our ability to raise additional capital to finance our operations.

Cash Flows

The following table summarizes our sources and uses of cash for each of the periods presented:


	Six months ended June 30,						Increase
	2021			2020			(Decrease)
	( in thousands)
Net cash used in operating activities	$	(29,696	)	$	(16,042	)	$	13,654
Net cash provided by investing activities		49,617			—			49,617
Net cash provided by financing activities		134			92,146			(92,012	)

Net increase in cash, cash equivalents and restricted cash	$	20,055		$	76,104		$	(56,049	)

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Operating Activities

During Q2 YTD 2021, net cash used in operating activities was $29.7 million, primarily resulting from of our net loss of $33.1 million, which was partially offset by

non-cash

charges of $3.1 million and cash provided by working capital of $0.3 million.

During Q2 YTD 2020, net cash used in operating activities was $16.0 million, primarily resulting from our net loss of $16.1 million and cash used in working capital of $0.2 million, partially offset by

non-cash

charges of $0.3 million.

Investing Activities

Net cash provided by investing activities of $49.6 million during Q2 YTD 2021 reflects net liquidations of the Company’s

available-for-sale

investments of $50.0 million to fund current and future operating activities, partially offset by investments in machinery and equipment of $0.4 million.

Financing Activities

Net cash provided by financing activities in Q2 YTD 2021 was $0.1 million and consisted of proceeds from the exercise of stock options.

Net cash provided by financing activities in Q2 YTD 2020 was $92.1 million and consisted of the net proceeds from the issuance of Series B and Series C redeemable convertible preferred stock of $82.5 million and the proceeds from the issuance of the Convertible Loan Notes of $10.0 million. These were partially offset by $0.4 million in expenditures related for issuance costs in anticipation of the Company’s IPO.

Funding Requirements

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials for vidutolimod and any other product candidates that we may develop or acquire in the future. In addition, we have incurred, and expect to incur, additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company. The timing and amount of our operating expenditures will depend largely on:

•

the initiation, progress, timing, costs and results of current and future preclinical studies and clinical trials for vidutolimod and any other product candidates we may develop or acquire in the future;

•

the cost and timing of the manufacture of additional clinical trial materials and the completion of commercial-scale outsourced manufacturing activities;

•

the costs to seek regulatory approvals for any product candidates that successfully complete clinical trials;

•

the extent to which we experience delays or interruptions to preclinical studies and clinical trials, to our third-party service providers on whom we rely, or to our supply chain due to the

COVID-19

pandemic;

•

the need to hire additional clinical, quality assurance, quality control and other scientific personnel

•

the number and characteristics of product candidates that we develop or may

in-license;

•

the outcome, timing and cost of meeting and maintaining compliance with regulatory requirements established by the U.S. Food and Drug Administration (the “FDA”), the European Medical Agency (the “EMA”) and other comparable foreign regulatory authorities;

•

the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

•

the terms of any collaboration agreements we may choose to enter into;

•

the cost associated with the expansion of our operational, financial and management systems and increased personnel, including personnel to support our operations as a public company; and

•

the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products, if approved, on our own.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interests may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take

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specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, debt financing would result in fixed payment obligations. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Contractual obligations and other commitments

We enter into contracts in the normal course of business with CROs, CMOs and other third parties for clinical trials, preclinical research studies and testing and manufacturing services. These contracts are cancelable by us upon prior written notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation. The amount and timing of such payments are not known.

We have also entered into license and collaboration agreements with third parties, which are in the normal course of business. We have not included future payments under these agreements since obligations under these agreements are contingent upon future events such as our achievement of specified development, regulatory, and commercial milestones, or royalties on net product sales.

Pursuant to the Kuros License Agreement, we are required to make payments to Kuros for each product that achieves certain development and regulatory milestones. We are obligated to make up to $56.0 million in milestone payments to Kuros related to vidutolimod. We are also required to pay royalties on sales of future products, if any. As of June 30, 2021, we have incurred license fees and milestone payments totaling $8.3 million pursuant to the Kuros License Agreement. These payments are comprised of (i) a license fee of $1.0 million which was recognized in research and development expense in 2015, (ii) $1.0 million milestone payment in connection with the dosing of the first patient in our first Phase 1 clinical trial, which was recognized in research and development expense in 2016, (iii) a $0.3 million license amendment fee in connection with the signing of the second amendment to the Kuros License Agreement, which was recognized in research and development expense in 2018, (iv) a $2.0 million milestone payment in connection with the dosing of the first patient in the Phase 2 first-line melanoma trial for vidutolimod, which we recognized in March 2021 and (v) a $4.0 million milestone payment in connection with the dosing in a Phase 2 trial intended to assess the efficacy and safety of vidutolimod in combination with nivolumab for the treatment of patients with

anti-PD-1

refractory melanoma and to potentially support a Biologics License Application (“BLA”) and marketing approval of vidutolimod, which we recognized in May 2021.

We do not currently have any long-term leases. We rent our office space in Cambridge, Massachusetts based on a

month-to-month

license agreement with the landlord.

Critical Accounting Policies and Significant Judgments and Estimates

Our unaudited condensed consolidated financial statements are prepared in accordance with GAAP. The preparation of our unaudited condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses. We base our estimates on historical experience, known trends and events and various other factors that we believe 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. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Critical Accounting Policies and Use of Estimates” in our 2020 Annual Report on Form

10-K.

There have been no changes to the critical accounting policies during the six months ended June 30, 2021.

Off-balance

sheet arrangements

We did not have during the periods presented, and we do not currently have, any

off-balance

sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission.

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Recent accounting pronouncements

A description of recently issued and recently adopted accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form

10-Q.

Emerging Growth Company and Smaller Reporting Company Status

The Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to not “opt out” of this provision and, as a result, we will adopt new or revised accounting standards at the time private companies adopt the new or revised accounting standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. Other exemptions and reduced reporting requirements under the JOBS Act for emerging growth companies include presentation of only two years of audited financial statements in a registration statement for an initial public offering, an exemption from the requirement to provide an auditor’s report on internal controls over financial reporting pursuant to the Sarbanes-Oxley Act of 2012, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about our executive compensation arrangements. We would cease to be an emerging growth company upon the earliest of: (1) the last day of the fiscal year ending after the fifth anniversary of our initial public offering; (2) the last day of the fiscal year in which we have more than $1.07 billion in annual revenue; (3) the last day of the fiscal year in which we qualify as a “large accelerated filer,” with at least $700.0 million of equity securities held by

non-affiliates

as of the prior June 30th; or (4) the issuance, in any three-year period, by our company of more than $1.0 billion in

non-convertible

debt securities held by

non-affiliates.

We are also a “smaller reporting company” and we may take advantage of certain of the scaled disclosures available to smaller reporting companies until the fiscal year following the determination that (i) the market value of our stock held by

non-affiliates

is more than $250 million or (ii) our annual revenue was more than $100 million during the most recently completed fiscal year and the market value of our stock held by

non-affiliates

is more than $700 million measured on the last business day of our second fiscal quarter. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form

10-K

and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Interest rate risk

We are exposed to market risk related to changes in interest rates. Our current investment policy is to maintain an investment portfolio consisting mainly of United States money market, government-secured, and high-grade corporate securities, directly or through managed funds, with maturities of twenty-four months or less. Our cash is deposited in and invested through highly rated financial institutions in North America. Our investments are subject to interest rate risk and will fall in value if market interest rates increase. However, due to the conservative nature of our investments, low prevailing market rates and relatively short effective maturities of debt instruments, interest rate risk is mitigated. If market interest rates were to increase immediately and uniformly by 10% from levels at June 30, 2021, we estimate that the fair value of our investment portfolio would decline by an immaterial amount. We do not own derivative financial instruments in our investment portfolio.

Foreign currency exchange risk

Our primary exposure to market risk is foreign exchange rate sensitivity to the British Pound. Foreign currency losses were neglectable in each of the six months ended June 30, 2021 and 2020. These foreign currency transaction losses were recorded as a component of general and administrative expense in our condensed consolidated statements of operations. At June 30, 2021, an immediate 5% change in the British Pound exchange rate would not have a material effect on our results of operations.

As we continue to grow our business, our results of operations and cash flows may increasingly be subject to fluctuations due to changes in foreign currency exchange rates, which could adversely impact our results of operations. To date, we have not entered into any foreign currency hedging contracts to mitigate our exposure to foreign currency exchange risk.

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Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

We have carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in

Rules 13a-15(e) and

15d-15(e) under

the Exchange Act), as of June 30, 2021. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective in ensuring that (a) the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (b) such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the six months ended June 30, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Limitations on the Effectiveness of Controls

Systems of disclosure controls and internal controls over financial reporting and their associated policies and procedures, no matter how well conceived and operated, are designed to provide a reasonable, but not an absolute, level of assurance that the objectives of the system of control are achieved. Further, the design of a control system must be balanced against resource constraints, and therefore the benefits of controls must be considered relative to their costs. Given the inherent limitations in all systems of controls, no evaluation of controls can provide absolute assurance all control issues and instances of fraud, if any, within a company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Accordingly, given the inherent limitations in a cost-effective system of internal control, financial statement misstatements due to error or fraud may occur and may not be detected. Our disclosure controls and procedures are designed to provide a reasonable assurance of achieving their objectives. We conduct periodic evaluations of our systems of controls to enhance, where necessary, our control policies and procedures.

PART II. – OTHER INFORMATION

Item 1. Legal Proceedings

From

time-to-time,

we may become involved in legal proceedings arising in the ordinary course of our business. As of the date of this Quarterly Report on Form

10-Q,

we were not a party to any material legal matters or claims. In the future, we may become party to legal matters and claims in the ordinary course of business, the resolution of which we do not anticipate would have a material adverse impact on our financial position, results of operations or cash flows.

Item 1A. Risk Factors

In evaluating the Company and our business, careful consideration should be given to the following risk factors, in addition to the other information set forth in this Quarterly Report on

Form 10-Q

and in other documents that we file with the SEC. Investing in our common stock involves a high degree of risk. If any of the following risks and uncertainties actually occurs, our business, prospects, financial condition or results of operations could be materially and adversely affected. The risks described below are not intended to be exhaus