nexi-20220930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

______________________

FORM 10-Q

______________________


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

For the quarterly period ended September 30, 2022


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

For the transition period from to

Commission File Number: 001-40045

______________________

NEXIMMUNE, INC.

(Exact Name of Registrant as Specified in its Charter)

______________________


Delaware		42-2518457
(State or other jurisdiction of incorporation or organization)		(IRS Employer Identification No.)

9119 Gaither Road
Gaithersburg,	MD	20877
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (301) 825-9810

______________________

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

Title of Each Class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share

NEXI

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 x No o

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 x No o

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

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. o

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

As of November 1, 2022, the registrant had 26,078,451 shares of common stock, $0.0001 par value per share, outstanding.

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			Page
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS			1
PART I -	FINANCIAL INFORMATION		3
	Item 1.	Financial Statements	3
		Balance sheets (unaudited)	3
		Statements of Operations (unaudited)	4
		Statements of Comprehensive Loss (unaudited)	5
		Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) (unaudited)	6
		Statements of Cash Flows (unaudited)	8
		Notes to Unaudited Financial Statements	9
	Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20
	Item 3.	Quantitative and Qualitative Disclosures About Market Risk	31
	Item 4.	Controls and Procedures	32
PART II -	OTHER INFORMATION		30
	Item 1.	Legal Proceedings	30
	Item 1A.	Risk Factors	30
	Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	31
	Item 3.	Defaults Upon Senior Securities	32
	Item 4.	Mine Safety Disclosures	32
	Item 5.	Other Information	32
	Item 6.	Exhibits	32
SIGNATURES			34

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

•our ability to execute successfully on our strategic realignment announced in November 2022, including with respect to our realigned focus on the development of the AIM INJ platform;

•our ability to obtain and maintain regulatory approval of our potential product candidates, including any potential product candidates developed using our AIM INJ platform or any of NEXI-001, NEXI-002 or NEXI-003;

•our ability to successfully commercialize and market our potential product candidates, including any potential product candidates developed using our AIM INJ platform or any of NEXI-001, NEXI-002 or NEXI-003, in each case if approved;

•our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately;

•the potential market size, opportunity and growth potential for our potential product candidates, including any potential product candidates developed using our AIM INJ platform or any of NEXI-001, NEXI-002, and NEXI-003, in each case if approved;

•our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize our potential product candidates, including any potential product candidates developed using our AIM INJ platform or any of NEXI-001, NEXI-002 or NEXI-003, in each case if approved;

•our ability to obtain funding for our operations;

•the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs;

•the timing of anticipated regulatory filings;

•the timing of availability of data from our clinical trials;

•the impact of the ongoing COVID-19 pandemic and our response to it;

•the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing;

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

•our ability to advance product candidates into, and successfully complete, clinical trials;

•our ability to recruit and enroll suitable patients in our clinical trials;

•the timing or likelihood of the accomplishment of various scientific, clinical, regulatory and other product development objectives;

•the pricing and reimbursement of our product candidates, if approved;

•the rate and degree of market acceptance of our product candidates, if approved;

•the implementation of our business model and strategic plans for our business, product candidates and technology;

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

•developments relating to our competitors and our industry;

•the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing;

•the development of major public health concerns, including the novel coronavirus outbreak or other pandemics arising globally, and the future impact of it and COVID-19 on our clinical trials, business operations and funding requirements; and

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•our financial performance.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the “Risk Factors” section and elsewhere in this Form 10-Q. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Form 10-Q may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable as of the date of this Form 10-Q, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Form 10-Q to conform these statements to new information, actual results or to changes in our expectations, except as required by law.

You should read this Form 10-Q and the documents that we reference in this Form 10-Q and have filed with the Securities and Exchange Commission, or SEC, as exhibits to this Form 10-Q with the understanding that our actual future results, levels of activity, performance, and events and circumstances may be materially different from what we expect.

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PART I - FINANCIAL INFORMATION

Item 1. Financial Statements.

NEXIMMUNE, INC.

BALANCE SHEETS


	September 30, 2022		December 31, 2021
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	45,860,454	$	30,326,352
Marketable securities	—		51,491,942
Restricted cash	105,000		67,500
Prepaid expenses and other current assets	6,034,874		4,394,916
Total current assets	52,000,328		86,280,710
Property and equipment, net	4,506,566		4,427,307
Operating lease right-of-use assets	1,095,475		—
Other non-current assets	72,079		324,099
Total assets	$	57,674,448	$	91,032,116
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,260,511	$	1,045,159
Accrued expenses	7,539,235		6,170,709
Operating lease liabilities, current	594,664		—
Total current liabilities	9,394,410		7,215,868
Operating lease liabilities, net of current portion	564,505		—
Deferred rent, net of current portion	—		55,581
Total liabilities	9,958,915		7,271,449
Commitments and contingencies
Stockholders’ equity
Common Stock, $0.0001 par value, 250,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 26,078,451 and 22,828,904 shares issued and outstanding as of September 30, 2022 and December 31, 2021	2,608		2,283
Additional paid-in-capital	221,069,554		211,498,827
Accumulated other comprehensive (loss) income	—		3,012
Accumulated deficit	(173,356,629)		(127,743,455)
Total stockholders’ equity	47,715,533		83,760,667
Total liabilities and stockholders’ equity	$	57,674,448	$	91,032,116

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

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NEXIMMUNE, INC.

STATEMENTS OF OPERATIONS

(unaudited)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Revenue	$	—	$	—	$	—	$	—
Operating expenses:
Research and development	11,136,500		11,331,189		33,422,862		25,468,770
General and administrative	3,719,601		4,159,196		12,412,725		12,254,838
Total operating expenses	14,856,101		15,490,385		45,835,587		37,723,608
Loss from operations	(14,856,101)		(15,490,385)		(45,835,587)		(37,723,608)
Other income (expense):
Interest income	226,752		19,855		344,066		30,319
Change in fair value of derivative liability	—		—		—		2,424,877
Gain on extinguishment of debt	—		843,619		—		843,619
Interest expense	—		(1,106)		—		(905,326)
Other expense	(100,031)		(19,095)		(121,653)		(45,791)
Other income	126,721		843,273		222,413		2,347,698
Net loss	$	(14,729,380)	$	(14,647,112)	$	(45,613,174)	$	(35,375,910)
Accumulated dividends on Redeemable Convertible Preferred Stock	—		—		—		(377,562)
Net loss attributable to common stockholders	$	(14,729,380)	$	(14,647,112)	$	(45,613,174)	$	(35,753,472)
Basic and diluted net loss attributable to common stockholders per common share	$	(0.60)	$	(0.65)	$	(1.95)

SEC Form 10-Q filed by NexImmune Inc.