Immuneering Corp 10-K for FY2021

Immuneering Corp (IMRX)

10-K 2022-03-10 For: 2021-12-31

Added on April 07, 2026

About this 10-K

Immuneering Corp filed this 10-K on March 10, 2022, covering the fiscal year ended December 31, 2021 (FY2021).

Headline figures

Fiscal year ended December 31, 2021, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $2.08M; down 10.0% from $2.31M a year earlier
Net loss: $33.54M; compared with a net loss of $17.04M a year earlier
Diluted EPS: -$2.46; compared with -$3.44 a year earlier

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Delaware	26-1976972
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification Number)

245 Main St.
Second Floor
Cambridge, MA	02142
(Address of Principal Executive Offices)	(Zip Code)


Title of Each Class	Trading symbol	Name of Exchange on which registered
Class A common Stock, par value $0.001 per share	IMRX	The Nasdaq Global Market

Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒	Emerging growth company	☒

		Page
PART I

Item 1.	Business	7

Item 1A.	Risk Factors	55

Item 1B.	Unresolved Staff Comments	116

Item 2.	Properties	116

Item 3.	Legal Proceedings	116

Item 4.	Mine Safety Disclosures	116

PART II

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	116

Item 6.	[Reserved]	117

Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	117

Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	129

Item 8.	Financial Statements and Supplementary Data	130

Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	157

Item 9A.	Controls and Procedures	157

Item 9B.	Other Information	157

Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	157

PART III

Item 10.	Directors, Executive Officers and Corporate Governance	158

Item 11.	Executive Compensation	158

Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	158

Item 13.	Certain Relationships and Related Transactions, and Director Independence	158

Item 14.	Principal Accounting Fees and Services	158

PART IV

Item 15.	Exhibits, Financial Statement Schedules	158

Item 16.	Form 10-K Summary	160

	•		expanded beneficiary eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 138% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
	•		expanded the types of entities eligible for the 340B Drug Pricing Program;
	•		required manufacturers to participate in a coverage gap discount program, under which they must agree to offer 70 percent point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
	•		imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” and biologic agents apportioned among these entities according to their market share in certain federal government programs;
	•		established the Center for Medicare and Medicaid Innovation within the Centers for Medicare and Medicaid Services (“CMS”) to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending;
	•		created the Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and
	•		required annual reporting of certain information regarding drug samples that manufacturers and distributors provide to licensed practitioners.


	•		required collection of rebates for drugs paid by Medicaid managed care organizations;


	Year Ended December 31,				Change
	2021		2020		$		%

	(in thousands, except percentages)

Revenue	$	2,080	$	2,311	$	(231)	(10.0)	%
Cost of revenue		1,153		1,280		(127)	(9.9)	%
Gross profit		927		1,031		(104)	(10.1)	%
Operating expenses
Research and development		26,541		15,004		11,537	76.9	%
General and administrative		8,272		3,110		5,162	166.0	%
Total operating expenses		34,813		18,114		16,699	92.2	%
Loss from operations		(33,886)		(17,083)		(16,803)	98.4	%

Other income (expense)
Interest income		170		43		127	295.3	%
Other expense		(127)		—		(127)	N/M	%
Loss before income taxes		(33,843)		(17,040)		(16,803)	98.6
Income tax benefit		307		—		307	N/M	%
Net loss	$	(33,536)	$	(17,040)


	Page(s)
Report of Independent Registered Public Accounting Firm (PCAOB ID: 49)	131
Consolidated Balance Sheets	132
Consolidated Statements of Operations and Comprehensive Loss	133
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)	134
Consolidated Statements of Cash Flows	135
Notes to Consolidated Financial Statements	136


	December 31, 2021		December 31, 2020

Assets
Current assets:
Cash and cash equivalents	$	74,888,145	$	37,090,151
Marketable securities, current		74,311,203		—
Accounts receivable		246,040		500,110
Prepaids and other current assets		2,888,608		140,958
Total current assets		152,333,996		37,731,219

Marketable securities, non-current		996,560		—
Property and equipment, net		807,223		64,363
Goodwill		6,701,726		—
Intangible asset		439,000		—
Right-of-use assets, net		5,324,198		613,103
Other assets		102,129		14,333
Total assets	$	166,704,832	$	38,423,018

Liabilities, convertible preferred stock and stockholders' equity (deficit)
Current liabilities:
Accounts payable	$	1,394,340	$	1,480,537
Accrued expenses		3,965,447		698,992
Lease liabilities, current		274,039		76,322
Total current liabilities		5,633,826		2,255,851

Long-term liabilities:
Lease liabilities, non-current		5,090,897		544,767
Total liabilities		10,724,723		2,800,618
Commitments and contingencies (Note 13)
Convertible preferred stock:
Series B preferred stock, $0.001 par value, 0 and 6,032,183 shares authorized at December 31, 2021 and December 31, 2020, 0 and 3,619,292 shares issued and outstanding at December 31, 2021 and December 31, 2020		—		36,983,910
Series A preferred stock, $0.001 par value, 0 and 2,495,933 shares authorized at December 31, 2021 and December 31, 2020, 0 and 2,495,933 shares issued and outstanding at December 31, 2021 and December 31, 2020		—		21,119,940
Total convertible preferred stock		—		58,103,850
Stockholders’ deficit:
Preferred stock, $0.001 par value; 10,000,000 and 0 shares authorized at December 31, 2021 and December 31, 2020, respectively; No shares issued or outstanding		—		—
Class A common stock, $0.001 par value, 200,000,000 and 22,026,200 shares authorized at December 31, 2021 and December 31, 2020 respectively; 26,320,199 and 4,950,129 shares issued and outstanding at December 31, 2021 and December 31, 2020		26,320		4,950
Class B common stock, $0.001 par value, 20,000,000 and 6,032,183 shares authorized at December 31, 2021 and December 31, 2020 respectively; 0 shares issued and outstanding at December 31, 2021 and December 31, 2020		—		—
Additional paid-in capital		215,276,186		3,251,240
Accumulated other comprehensive loss		(49,009)		—
Accumulated deficit		(59,273,388)		(25,737,640)
Total stockholders' equity (deficit)		155,980,109		(22,481,450)
Total liabilities, convertible preferred stock and stockholders' equity (deficit)	$	166,704,832	$	38,423,018


	Convertible Preferred Stock									Stockholders' Equity (Deficit)
								Total									Additional		Accumulated other				Total
	Series B			Series A				Convertible		Class A Common Stock				Class B Common Stock			Paid-In		comprehensive		Accumulated		Stockholders'
	Shares	Amount		Shares		Amount		Preferred Stock		Shares		Par Value		Shares	Par Value		Capital		loss		Deficit		Equity (Deficit)

Balance at December 31, 2019	—	$	—		1,966,043	$	16,611,832	$	16,611,832		4,950,129	$	4,950	—	$	—	$	2,164,471	$	—	$	(8,697,742)	$	(6,528,321)

Issuance of Series A convertible preferred stock, net of issuance costs	—		—		529,890		4,508,108		4,508,108		—		—	—		—		—		—		—		—

Issuance of Series B convertible preferred stock, net of issuance costs	3,619,292		36,983,910		—		—		36,983,910		—		—	—		—		—		—		—		—

Stock-based compensation expense	—		—		—		—		—		—		—	—		—		1,086,769		—		—		1,086,769

Net loss	—		—		—		—		—		—		—	—		—		—		—		(17,039,898)		(17,039,898)

Balance at December 31, 2020	3,619,292	$	36,983,910		2,495,933	$	21,119,940	$	58,103,850		4,950,129	$	4,950	—	$	—	$	3,251,240	$	—	$	(25,737,640)	$	(22,481,450)

Issuance of Series B convertible preferred stock, net of issuance costs	2,412,853		24,788,851		—		—		24,788,851		—		—	—		—		—		—		—		—

Issuance of common stock upon exercise of stock options	—		—		—		—		—		117,846		118	—		—		354,316		—		—		354,434

Issuance of common stock upon exercise of warrants	—		—		—		—		—		308,308		308	—		—		926,817		—		—		927,125

Conversion of Preferred Stock into common stock	(6,032,145)		(61,772,761)		(2,495,933)		(21,119,940)		(82,892,701)		11,939,281		11,939	—		—		82,880,762		—		—		82,892,701

Issuance of common stock upon initial public offering, net of issuance costs ($2,124,317)	—		—		—		—		—		8,625,000		8,625	—		—		118,185,808		—		—		118,194,433

Issuance of common stock for acquisition	—		—		—		—		—		379,635		380	—		—		7,874,620		—		—		7,875,000

Stock-based compensation expense	—		—		—		—		—		—		—	—		—		1,802,623		—		—		1,802,623

Net loss	—		—		—		—		—		—		—	—		—		—		—		(33,535,748)		(33,535,748)

Other comprehensive loss	—		—		—		—		—		—		—	—		—		—		(49,009)		—		(49,009)

Balance at December 31, 2021	—	$	—		—	$	—	$	—		26,320,199	$	26,320	—	$	—	$	215,276,186	$	(49,009)	$	(59,273,388)	$	155,980,109


	2021		2020

Cash flows from operating activities:
Net loss	$	(33,535,748)	$	(17,039,898)
Adjustment to reconcile to net loss to net cash used in operating activities:
Depreciation expense		45,467		24,328
Right-of-use asset amortization		113,605		54,977
Stock based compensation expense		1,802,623		1,086,769
Net amortization of premium (accretion of discount) on marketable securities		130,240		—
Deferred tax benefit		(307,485)		—
Change in assets and liabilities:
(Increase) decrease in:
Accounts receivable		279,713		(290,170)
Prepaid expenses and other current assets		(2,408,986)		(69,740)
Other assets		—		(14,333)
Increase (decrease) in:
Accounts payable		(130,398)		1,185,589
Accrued expenses		3,240,940		488,644
Lease liability		(80,853)		(46,991)
Net cash used in operating activities		(30,850,882)		(14,620,825)
Cash flows from investing activities:
Purchases of property and equipment		(60,786)		(53,415)
Purchases of marketable securities		(75,625,529)		—
Cash acquired in business combination		70,348		—
Net cash used in investing activities		(75,615,967)		(53,415)
Cash flows from financing activities:
Proceeds from the issuance of Series A preferred stock, net of issuance costs		—		998,306
Proceeds from the issuance of Series B preferred stock, net of issuance costs		24,788,851		36,983,910
Proceeds from initial public offering of common stock, net of commissions and underwriting		120,318,750		—
Payment of initial public offering costs		(2,124,317)		—
Proceeds from exercise of stock options		354,434		—
Proceeds from exercise of warrants		927,125		—
Net cash provided by financing activities		144,264,843		37,982,216
Net increase in cash and cash equivalents		37,797,994		23,307,976
Cash and cash equivalents at beginning of period		37,090,151		13,782,175
Cash and cash equivalents at end of period	$	74,888,145	$	37,090,151
Supplemental disclosures of noncash investing and financing information:
Conversion of convertible Series A and B preferred stock into common stock	$	82,892,701	$	—
Business combination non cash		7,804,652		—
Class A common stock issued for business combination		7,875,000		—
Reclassification of liability for Series A preferred stock		—		3,509,802


	Year Ended December 31, 2021				As of December 31, 2021
	Revenue		% of Total		Accounts Receivable		% of Total
Customer #1	$	745,030	35.8	%	$	235,500	95.7%	%
Customer #2		380,000	18.3			*	*
Customer #5		353,050	17.0			*	*


	Year Ended December 31, 2020				As of December 31, 2020
	Revenue		% of Total		Accounts Receivable		% of Total
Customer #1	$	676,710	29.3	%	$	214,345	42.9	%
Customer #2		570,000	24.7			71,250	14.2
Customer #3		306,900	13.3			*	*
Customer #4		250,880	10.9			63,000	12.6
Customer #5		*	*			91,975	18.4


		Estimated
Asset Class		Useful Lives
Computer equipment		3 years
Furniture and fixtures		5 years
Lab equipment		7 years
Leasehold improvements		1-10 years


	December 31, 2021
	Amortized Cost		Unrealized Gains		Unrealized Losses		Fair Value
Assets:
Current:
U.S. Treasuries	$	42,147,385	$	-	$	(28,575)	$	42,118,810
Government securities		19,218,057		-		(13,689)		19,204,368
Commercial Paper		12,992,165		57		(4,197)		12,988,025
Total Current		74,357,607		57		(46,461)		74,311,203

Non-current:
U.S. Treasuries		999,186		-		(2,626)		996,560
Government securities		-		-		-		-
Total Non-current		999,186		-		(2,626)		996,560
Total marketable securities	$	75,356,793	$	57	$	(49,087)	$	75,307,763


		Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents
Money market	$	33,961,344	$	-	$	-	$	33,961,344
Commercial paper		-		2,000,000		-		2,000,000
Total cash equivalents		33,961,344		2,000,000		-		35,961,344

Marketable securities:
U.S. Treasuries	$	43,115,370	$	-	$	-	$	43,115,370
Government securities		-		19,204,368		-		19,204,368
Commercial paper		-		12,988,025		-		12,988,025
Total marketable securities		43,115,370		32,192,393		-		75,307,763
Total cash equivalents and marketable securities	$	77,076,714	$	34,192,393	$	-	$	111,269,107


	December 31,		December 31,
	2021		2020

Computer equipment	$	281,666	$	174,317
Furniture and fixtures		84,477		18,798
Lab equipment		463,182		-
Leasehold improvements		152,117		-
Total		981,442		193,115
Accumulated depreciation		(174,219)		(128,752)
Property and equipment, net	$	807,223	$	64,363


	Preliminary Valuation		Weighted Average Life
Cash	$	70,348
Other currents assets		225,790
Other long term assets		87,796
Property, plant and equipment, net		727,539
Right of use assets		4,824,700
Intangible asset
Technology		439,000		15 years
Goodwill		6,701,726

Total assets acquired		13,076,899

Accounts payable, accrued expenses and other liabilities		69,714
Deferred tax liabilities		307,485
Lease liabilities		4,824,700
Net assets acquired	$	7,875,000


	2021	2020

Series A Preferred	—	3,494,306
Series B Preferred	—	5,066,995
Warrants to purchase common stock	—	308,308
Options to purchase common stock	2,859,544	1,801,263
Total shares of common stock equivalents	2,859,544	10,670,872


				Weighted
		Weighted-		Average
		Average		Remaining
	Number of	Exercise Price		Contractual	Aggregate
	Options	per Share		Term (in Years)	Intrinsic Value

Outstanding at of December 31, 2020	1,801,263	$	3.01
Granted	1,452,462		10.07
Exercised	(117,847)		3.01
Cancelled	(276,334)		3.58
Outstanding at December 31, 2021	2,859,544	$	6.55	8.30	$	27,615,466

Vested and exercisable at December 31, 2021	1,102,543	$	3.01	7.14	$	14,507,723
Vested and expected to vest at December 31, 2021	2,859,544	$	6.55	8.30	$	27,615,466


	2021		2020
Statutory federal income tax rate	21.0	%	21.0	%
State tax, net of federal benefit	5.5	%	6.3	%
Permanent differences	(0.6)	%	(1.5)	%
Federal research and development credits	5.6	%	4.5	%
State research and development credits	0.4	%	0.6	%
Uncertain tax positions	(0.6)	%	(1.0)	%
Other differences	0.7	%	(2.6)	%
Change in valuation allowance	(31.1)	%	(27.3)	%
Effective income tax rate	0.9	%	0.0	%


	2021		2020
Deferred tax assets:
Stock-based compensation expense	$	373,602	$	73,984
Unrealized losses		12,990		—
R&D credit carryforward		3,346,097		1,574,596
NOL carryforward		14,699,524		5,525,123
Gross deferred tax assets		18,432,213		7,173,703
Valuation allowance		(17,677,899)		(7,127,448)
Net deferred tax assets		754,314		46,255
Net deferred tax liabilities:
Prepaid expenses deducted for tax		(425,755)		(28,671)
Tax depreciation in excess of book		(328,559)		(17,584)
Total deferred tax liabilities		(754,314)		(46,255)
Net deferred taxes	$	—	$	—


	2021		2020
Beginning balance	$	174,950	$	96,952
Increase due to current year tax position		205,952		77,998
Ending balance	$	380,902	$	174,950


	Amount
2022	$	659,990
2023		880,121
2024		894,044
2025		906,839
2026		819,210
Thereafter		4,467,246
Total future lease payments		8,627,450
Less: Imputed interest		3,262,514
Total lease liabilities	$	5,364,936
Current portion lease liabilities		274,039
Lease liabilities, noncurrent		5,090,897
Total lease liabilities	$	5,364,936

op
		Incorporated by Reference				Filed/
Exhibit Number	Exhibit Description	Form	File No.	Exhibit	Filing Date	Furnished Herewith

2.1	Share Purchase Agreement by and among Immuneering Corporation, BioArkive, Inc. and BioArkive’s shareholders, dated as of December 22, 2021	8-K	001-40675	2.1	12/22/2021
3.1	Amended and Restated Certificate of Incorporation of Immuneering Corporation	10-Q	001-40675	3.1	09/09/2021
3.2	Amended and Restated Bylaws of Immuneering Corporation	10-Q	001-40675	3.2	09/09/2021
4.1	Form of Specimen Stock Certificate	S-1/A	333-257791	4.1	07/26/2021
4.2	Amended and Restated Investors’ Rights Agreement, dated December 21, 2020, by and among the Registrant and the other parties thereto.	S-1/A	333-257791	4.2	07/26/2021
4.3	Description of Securities					*
10.1†	Employment Agreement, dated July 23, 2021, by and between Biren Amin and Immuneering Corporation	S-1/A	333-257791	10.5	07/26/2021
10.2†	Employment Agreement, dated July 23, 2021, by and between Brett Hall, Ph.D. and Immuneering Corporation	S-1/A	333-257791	10.6	07/26/2021
10.3†	Employment Agreement, dated July 23, 2021, by and between Scott Barrett, M.D. and Immuneering Corporation	S-1/A	333-257791	10.7	07/26/2021
10.4†	Employment Agreement, dated July 23, 2021, by and between Benjamin J. Zeskind, Ph.D. and Immuneering Corporation	S-1/A	333-257791	10.8	07/26/2021
10.5†	Employment Agreement, dated July 23, 2021, by and between Michael D. Bookman and Immuneering Corporation	S-1/A	333-257791	10.9	07/26/2021
10.6†	Immuneering Corporation 2008 Stock Incentive Plan and form of option agreement thereunder.	S-1	333-257791	10.4	07/09/2021
10.7†	Immuneering Corporation Long Term Incentive Plan and form of option agreement thereunder.	S-1	333-257791	10.5	07/09/2021
10.8†	Immuneering Corporation 2021 Incentive Award Plan and forms of award agreements thereunder.	S-1/A	333-257791	10.10	07/26/2021
10.9†	Immuneering Corporation 2021 Employee Stock Purchase Plan.	S-1/A	333-257791	10.11	07/26/2021
10.10†	Form of Indemnification Agreement by and among the Registrant and its directors and officers.	S-1/A	333-257791	10.12	07/26/2021
10.11†	Immuneering Corporation Non-Employee Director Compensation Program.	S-1/A	333-257791	10.13	07/26/2021
10.12	Advisory Agreement, dated September 17, 2019, by and between PEF LLC and the Registrant.	S-1	333-257791	10.3	07/09/2021
10.13	Master Services Agreement, dated August 5, 2019, by and between Bioarkive LLC and the Registrant.	S-1	333-257791	10.2	07/09/2021
10.14	Lease Agreement, by and between BioArkive, Inc. and Thornmint 13, LLC, dated as of July 22, 2021	8-K	001-40675	10.1	12/22/2021
21.1	Subsidiaries of Immuneering Corporation					*
23.1	Consent of RSM US, LLP, Independent Registered Pubic Accounting Firm					*
31.1	Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a).					*
31.2	Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a).					*
32.1	Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350.					**
32.2	Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350.					**


	IMMUNEERING CORPORATION

Date: March 10, 2022	By:	/s/ Benjamin J. Zeskind
	Name:	Benjamin J. Zeskind, Ph.D.
	Title:	Co-Founder, President, Chief Executive Officer and Director (Principal Executive Officer)


Name	Title	Date

/s/ Benjamin J. Zeskind	President, Chief Executive Officer and Director (Principal Executive Officer)	March 10, 2022
Benjamin J. Zeskind, Ph.D.

/s/ Biren Amin	Chief Financial Officer (Principal Financial and Accounting Officer)	March 10, 2022
Biren Amin

/s/ Ann E. Berman	Director	March 10, 2022
Ann E. Berman

/s/ Robert J. Carpenter	Director	March 10, 2022
Robert J. Carpenter

/s/ Peter Feinberg	Director	March 10, 2022
Peter Feinberg

/s/ Diana F. Hausman, MD	Director	March 10, 2022
Diana F. Hausman, MD

/s/ Laurie B. Keating	Director	March 10, 2022
Laurie B. Keating



	By:	/s/ Benjamin J. Zeskind
	Name:	Benjamin J. Zeskind, Ph.D
	Title:	Co-Founder, President, Chief Executive Officer and Director (Principal Executive Officer)

J.

	By:	/s/ Biren Amin
	Name:	Biren Amin
	Title:	Chief Financial Officer and Treasurer
		(Principal Financial Officer and Principal Accounting Officer)