10-Q

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 September 30, 2022

OR

☐ 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: 001-39662

SQZ BIOTECHNOLOGIES COMPANY

(Exact Name of Registrant as Specified in its Charter)

Delaware	46-2431115
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
200 Arsenal Yards Blvd, Suite 210 Watertown, MA	02472
(Address of principal executive offices)	(Zip Code)

(617) 758-8672

(Registrant’s telephone number, including area code)

N/A

(Former name, former address and former fiscal year, if changed since last report)

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, $0.001 par value per share	SQZ	New York Stock Exchange

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

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

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

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

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

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

As of November 3, 2022, the registrant had 29,450,616 shares of common stock, $0.001 par value per share, outstanding.

SQZ BIOTECHNOLOGIES COMPANY

Table of Contents

		Page
	Forward-Looking Statements		1
PART I.	FINANCIAL INFORMATION		2
Item 1.	Financial Statements (Unaudited):
	Condensed Consolidated Balance Sheets		2
	Condensed Consolidated Statements of Operations and Comprehensive Loss		3
	Condensed Consolidated Statements of Stockholders’ Equity		4
	Condensed Consolidated Statements of Cash Flows		5
	Notes to Unaudited Condensed Consolidated Financial Statements		6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		15
Item 3.	Quantitative and Qualitative Disclosures About Market Risk		27
Item 4.	Controls and Procedures		27
PART II.	OTHER INFORMATION		29
Item 1.	Legal Proceedings		29
Item 1A.	Risk Factors		29
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds		30
Item 3.	Defaults Upon Senior Securities		30
Item 4.	Mine Safety Disclosures		30
Item 5.	Other Information		30
Item 6.	Exhibits		31
Signatures			34

i

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. All statements other than statements of historical fact contained in this Quarterly Report, including without limitation statements regarding our plans to develop, manufacture and commercialize our product candidates, the timing or outcome of our ongoing or planned clinical trials for SQZ-PBMC-HPV, SQZ-AAC-HPV, SQZ-eAPC-HPV or any of our other pipeline product candidates and any future product candidates, the clinical utility of our product candidates, the anticipated impact of the COVID-19 pandemic on our business and operations, including manufacturing, research and development, clinical trials and employees, our cash needs and availability, our plans to mitigate the risk that we are unable to continue as a going concern, and the plans and objectives of management for future operations, are forward-looking statements.

The forward-looking statements in this Quarterly Report are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from those projected in the forward-looking statements, including, but not limited to, risks and uncertainties related to our ability to continue as a going concern; our limited operating history; our significant losses incurred since inception and expectation to incur significant additional losses for the foreseeable future; the development of our initial product candidates, upon which our business is highly dependent; the impact of the COVID-19 pandemic on our operations and clinical activities; our need for additional funding and our cash runway; the lengthy, expensive, and uncertain process of clinical drug development, including uncertain outcomes of clinical trials and potential delays in regulatory approval; our ability to maintain our relationships with our third party vendors and strategic collaborators; protection of our proprietary technology, intellectual property portfolio and the confidentiality of our trade secrets; general economic conditions and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, this Quarterly Report on Form 10-Q and our other filings with the U.S. Securities and Exchange Commission.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

1

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

SQZ BIOTECHNOLOGIES COMPANY

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

	SEPTEMBER 30,			DECEMBER 31,
	2022			2021
Assets
Current assets:
Cash and cash equivalents	$	84,239		$	143,513
Accounts receivable		—			3,000
Prepaid expenses and other current assets		3,098			4,122
Total current assets		87,337			150,635
Property and equipment, net		2,521			3,046
Restricted cash		2,305			2,305
Deferred offering costs		306			323
Operating lease right-of-use assets		62,385			69,843
Total assets	$	154,854		$	226,152
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	3,311		$	3,971
Accrued expenses		7,823			6,810
Current portion of deferred revenue		3,500			12,507
Current portion of operating lease liabilities		10,627			9,936
Total current liabilities		25,261			33,224
Deferred revenue, net of current portion		9,196			9,196
Operating lease liabilities, net of current portion		51,823			59,756
Total liabilities		86,280			102,176
Commitments and contingencies (Note 8)
Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2022 and December 31, 2021; No shares issued or outstanding.		—			—
Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2022 and December 31, 2021; 29,350,158 and 28,133,368 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively.		29			28
Additional paid-in capital		329,972			319,458
Accumulated deficit		(261,427	)		(195,510	)
Total stockholders’ equity		68,574			123,976
Total liabilities and stockholders’ equity	$	154,854		$	226,152

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

2

SQZ BIOTECHNOLOGIES COMPANY

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

	THREE MONTHS ENDED SEPTEMBER 30,						NINE MONTHS ENDED SEPTEMBER 30,
	2022			2021			2022			2021
Revenue:
Collaboration revenue	$	3,130		$	4,755		$	9,011		$	14,748
Grant revenue		322			—			524			—
Total revenue		3,452			4,755			9,535			14,748
Operating expenses:
Research and development		19,631			20,520			55,401			52,942
General and administrative		6,919			6,691			20,789			18,744
Total operating expenses		26,550			27,211			76,190			71,686
Loss from operations		(23,098	)		(22,456	)		(66,655	)		(56,938	)
Other income (expense):
Interest income		436			8			608			28
Other income (expense), net		19			(2	)		130			(9	)
Total other income, net		455			6			738			19
Net loss and comprehensive loss		(22,643	)		(22,450	)		(65,917	)		(56,919	)
Net loss per share, basic and diluted	$	(0.77	)	$	(0.80	)	$	(2.30	)	$	(2.08	)
Weighted-average common shares outstanding, basic and diluted		29,284,151			28,050,130			28,603,020			27,421,839

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

3

SQZ BIOTECHNOLOGIES COMPANY

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except share amounts)

(Unaudited)

	COMMON STOCK
	SHARES		AMOUNT		ADDITIONAL PAID-IN CAPITAL		ACCUMULATED DEFICIT			TOTAL STOCKHOLDERS’ EQUITY
Balances at June 30, 2022		29,148,053	$	29	$	326,943	$	(238,784	)	$	88,188
Issuance of common stock under at-the-market offering, net of issuance costs of $3		202,105		—		653		—			653
Stock-based compensation expense		—		—		2,376		—			2,376
Net loss		—		—		—		(22,643	)		(22,643	)
Balances at September 30, 2022		29,350,158	$	29	$	329,972	$	(261,427	)	$	68,574

	COMMON STOCK				ADDITIONAL					TOTAL
	SHARES		AMOUNT		PAID-IN CAPITAL		ACCUMULATED DEFICIT			STOCKHOLDERS’ EQUITY
Balances at June 30, 2021		28,031,404	$	28	$	313,914	$	(161,238	)	$	152,704
Issuance of common stock upon exercise of stock options		33,365		—		171		—			171
Stock-based compensation expense		—		—		2,781		—			2,781
Net loss		—		—		—		(22,450	)		(22,450	)
Balances at September 30, 2021		28,064,769	$	28	$	316,866	$	(183,688	)	$	133,206

	COMMON STOCK
	SHARES		AMOUNT		ADDITIONAL PAID-IN CAPITAL		ACCUMULATED DEFICIT			TOTAL STOCKHOLDERS’ EQUITY
Balances at December 31, 2021		28,133,368	$	28	$	319,458	$	(195,510	)	$	123,976
Issuance of common stock upon exercise of stock options		14,757		—		29		—			29
Issuance of common stock under employee stock purchase plan		41,265		—		111		—			111
Issuance of common stock under at-the-market offering, net of issuance costs of $195		1,160,768		1		3,744		—			3,745
Stock-based compensation expense		—		—		6,630		—			6,630
Net loss		—		—		—		(65,917	)		(65,917	)
Balances at September 30, 2022		29,350,158	$	29	$	329,972	$	(261,427	)	$	68,574

	COMMON STOCK				ADDITIONAL					TOTAL
	SHARES		AMOUNT		PAID-IN CAPITAL		ACCUMULATED DEFICIT			STOCKHOLDERS’ DEFICIT
Balances at December 31, 2020		24,786,324	$	25	$	253,943	$	(126,769	)	$	127,199
Issuance of common stock upon public offering, net of issuance costs of $798		3,000,000		3		55,599		—			55,602
Issuance of common stock upon exercise of stock options		278,445		—		1,131		—			1,131
Stock-based compensation expense		—		—		6,193		—			6,193
Net loss		—		—		—		(56,919	)		(56,919	)
Balances at September 30, 2021		28,064,769	$	28	$	316,866	$	(183,688	)	$	133,206

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

4

SQZ BIOTECHNOLOGIES COMPANY

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

	NINE MONTHS ENDED SEPTEMBER 30,
	2022			2021
Cash flows from operating activities:
Net loss	$	(65,917	)	$	(56,919	)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation and amortization expense		833			932
Amortization of operating lease right-of-use assets		7,458			7,384
Stock-based compensation expense		6,630			6,193
Loss on disposal of equipment		43			7
Changes in operating assets and liabilities:
Accounts receivable		3,000			1,892
Prepaid expenses and other current assets		1,024			2,669
Accounts payable		(624	)		(507	)
Accrued expenses		1,013			(1,402	)
Deferred revenue		(9,007	)		(14,523	)
Operating lease liabilities		(7,242	)		(6,843	)
Net cash used in operating activities		(62,789	)		(61,117	)
Cash flows from investing activities:
Purchases of property and equipment		(421	)		(613	)
Proceeds from disposals of property and equipment		34			—
Net cash used in investing activities		(387	)		(613	)
Cash flows from financing activities:
Proceeds from follow-on public offering of common stock, net of commissions and underwriting discounts		—			56,400
Payment of public offering costs		—			(1,904	)
Proceeds from issuance of common stock under at-the market offering		3,762			—
Proceeds from issuance of common stock under employee stock purchase plan		111			—
Proceeds from exercise of stock options		29			1,131
Net cash provided by financing activities		3,902			55,627
Net (decrease) increase in cash, cash equivalents and restricted cash		(59,274	)		(6,103	)
Cash, cash equivalents and restricted cash at beginning of period		145,818			172,662
Cash, cash equivalents and restricted cash at end of period	$	86,544		$	166,559
Supplemental disclosure of non-cash investing and financing activities:
Lease assets obtained in exchange for operating lease liabilities	$	—		$	31,306

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

5

SQZ BIOTECHNOLOGIES COMPANY

Notes to Unaudited Condensed Consolidated Financial Statements

1. Nature of the Business and Basis of Presentation

SQZ Biotechnologies Company (the “Company”) is a clinical-stage biotechnology company developing cell therapies for patients with cancer, autoimmune and infectious diseases and other serious conditions. The Company uses its proprietary Cell Squeeze technology to physically squeeze cells through a microfluidic chip, temporarily opening the cell membrane and enabling biologic material of interest, or cargo, to diffuse into the cell. The Company is using Cell Squeeze technology to create multiple cell therapy platforms focused on directing specific immune responses. The Company was incorporated in March 2013 under the laws of the State of Delaware.

The Company is subject to a number of risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, the ability to obtain additional financing, protection of proprietary technology, dependence on key personnel, the ability to attract and retain qualified employees, compliance with government regulations, the impact of the COVID-19 pandemic, and the clinical and commercial success of its product candidates. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

Since inception, the Company has funded its operations primarily with payments received in connection with collaboration agreements, proceeds from equity and debt financing, and most recently, with proceeds from its 2020 initial public offering (“IPO”) and its 2021 follow-on offering. On November 10, 2021, the Company entered into an Open Market Sales Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) to issue and sell up to $75,000,000 in shares of the Company’s common stock from time to time during the term of the Sales Agreement through an “at-the-market” equity offering program under which Jefferies acts as the Company’s sales agent (the “ATM Facility”). During the nine months ended September 30, 2022, the Company sold 1,160,768 shares of common stock under the ATM Facility for net proceeds of approximately $3.7 million.

The Company has incurred recurring losses since inception, including net losses of $65.9 million for the nine months ended September 30, 2022. As of September 30, 2022, the Company had an accumulated deficit of $261.4 million. The Company expects to continue to generate operating losses for the foreseeable future. The Company’s current financial resources and currently forecasted operating plan would allow the Company to operate into the fourth quarter of 2023, but not for more than one year after the date that these condensed consolidated financial statements are issued. The Company is developing plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or debt financings, and/or potentially new collaborations, business transactions and reducing cash expenditures. If the Company is not able to secure adequate additional funding, the Company plans to make significant reductions in spending. In that event, the Company may have to delay, scale back, or eliminate some or all of the Company’s research and development programs and technology platform activities which could adversely affect its business prospects, or the Company may be unable to continue operations.

Management has assessed the Company’s ability to continue as a going concern in accordance with the requirements of ASC 205-40, taking into consideration its recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations. As of November 9, 2022, the issuance date of these interim condensed consolidated financial statements for the three and nine month periods ended September 30, 2022, the Company has concluded that there is substantial doubt about its ability to continue as a going concern for a period of one year from the date that these condensed consolidated financial statements are issued. The Company will require additional funding through private or public equity financings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into collaborations or other arrangements. The terms of any financing may adversely affect the holdings or the rights of the Company's stockholders. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. If the Company is unable to obtain funding, the Company will 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, or at all.

The accompanying condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. Accordingly, the consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.

6

Impact of the COVID-19 Pandemic

In December 2019, a novel strain of coronavirus, which causes the disease known as COVID-19, was initially reported and since then, COVID-19 has spread globally. In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic and the U.S. government-imposed travel restrictions on travel between the United States, Europe and certain other countries. The outbreak and government measures taken in response have had a significant impact, both direct and indirect, on hospitals, businesses and commerce, as worker shortages have occurred, supply chains have been disrupted, prices have increased, and the use of facilities and production have been suspended. The future progression of the pandemic and its effects on the Company’s business and operations are uncertain.

The COVID-19 pandemic has impacted and may continue to impact personnel at third-party manufacturing facilities or the availability or cost of materials, which would disrupt the Company’s supply chain. It also has affected and may continue to affect the Company’s ability to enroll patients in and timely complete its ongoing clinical trials of SQZ-PBMC-HPV, SQZ-AAC-HPV and SQZ-eAPC-HPV and delay the initiation of future clinical trials, disrupt regulatory activities or have other adverse effects on its business and operations.

The Company is monitoring the potential impact of the COVID-19 pandemic on its business and financial statements. To date, the Company has not incurred impairment losses in the carrying values of its assets as a result of the pandemic and it is not aware of any specific related event or circumstance that would require it to revise its estimates reflected in these interim condensed consolidated financial statements. The extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations, financial condition and liquidity, including planned and future clinical trials and research and development costs, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19, the actions taken to contain or treat it, and the duration and intensity of the related effects.

Basis of Presentation

The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, SQZ Biotechnologies Security Corporation, SQZ Biotech HK Limited and SQZ Biotech (Shanghai) Co., Ltd. All intercompany accounts and transactions have been eliminated in consolidation.

2. Summary of Significant Accounting Policies

Unaudited Interim Financial Information

The accompanying condensed consolidated financial statements as of September 30, 2022 and for the three and nine months ended September 30, 2022 and 2021 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. The accompanying condensed consolidated balance sheet as of December 31, 2021 was derived from audited financial statements but does not include all disclosures required by GAAP. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the SEC on March 16, 2022. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial position as of September 30, 2022, the consolidated results of operations for the three and nine months ended September 30, 2022 and 2021, and the consolidated cash flows for the nine months ended September 30, 2022 and 2021 have been made. The Company’s consolidated results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results of operations that may be expected for the full year or any other subsequent interim period.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, revenue recognition, the accrual of research and development expenses, and the valuation of stock-based awards. 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. On an ongoing basis, management evaluates its estimates, judgments and methodologies as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions.

Segment Information

7

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is developing methods of engineering cell function and therapies for the treatment of patients across a range of indications. The Company has determined that its chief operating decision maker is its Chief Executive Officer. The Company’s chief operating decision maker reviews the Company’s financial information on a consolidated basis for purposes of allocating resources and assessing financial performance.

Revenue Recognition for Government Grants

The Company generates revenue from government contracts that reimburse the Company for certain allowable costs for funded projects. For contracts with government agencies where the funding arrangement is considered central to the Company’s ongoing operations, the Company classifies the recognized funding received as revenue. Revenue from government grants is recognized as the qualifying expenses related to the contracts are incurred, provided that there is reasonable assurance of recoverability. The Company submits a budget, which outlines the expected project costs, to the funding government agency on a periodic basis. If the government agency approves the project proposed by the Company, the government agency generally funds the project upon receipt of the support for the costs incurred. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded as unbilled receivables, a component of prepaid expenses and other current assets, in the consolidated balance sheet. The related costs incurred by the Company are included in research and development expense in the Company’s consolidated statements of operations and comprehensive loss. In certain cases, the Company may obtain grants from an economic development agency that are not central to the Company's ongoing business. The income from these grants is recognized within Other income (expense), net in the consolidated statement of operations and comprehensive loss when there is reasonable assurance of recoverability.

Recently Issued Accounting Pronouncements

The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company will adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and will do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company. The Company may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for nonpublic companies.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes will result in the earlier recognition of credit losses, if any. In May 2019, the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”), which provides additional implementation guidance on the previously issued ASU 2016-13. For the Company, both ASU 2016-13 and ASU 2019-05 are effective for fiscal years beginning after December 15, 2022. The Company is currently evaluating the impact that the adoption of ASU 2016-13 will have on its consolidated financial statements, however the Company does not expect that the standard will have a material impact on its consolidated financial statements.

In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes (Topic 740) (“ASU 2019-12”), which simplifies the accounting for income taxes by eliminating certain exceptions, including the approach for intraperiod tax allocation, the accounting for income taxes in an interim period, hybrid taxes and the recognition of deferred tax liabilities for outside basis differences. It also clarifies and simplifies other aspects of the accounting for income taxes. The Company adopted this standard as of January 1, 2022 and the standard did not have a material impact on its consolidated financial statements.

In November 2021, the FASB issued ASU 2021-10, Disclosures by Business Entities about Government Assistance, which requires business entities to provide certain disclosures when they have 1) received government assistance and 2) use a grant or contribution accounting model by analogy to other accounting guidance. The Company adopted this standard as of January 1, 2022 and the standard did not have a material impact on its consolidated financial statements.

3. Fair Value Measurements

8

The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands):

	FAIR VALUE MEASUREMENTS AT SEPTEMBER 30, 2022 USING:
	LEVEL 1		LEVEL 2		LEVEL 3		TOTAL
Assets:
Cash equivalents:
Money market funds	$	83,107	$	—	$	—	$	83,107
	$	83,107	$	—	$	—	$	83,107

	FAIR VALUE MEASUREMENTS AT DECEMBER 31, 2021 USING:
	LEVEL 1		LEVEL 2		LEVEL 3		TOTAL
Assets:
Cash equivalents:
Money market funds	$	142,547	$	—	$	—	$	142,547
	$	142,547	$	—	$	—	$	142,547

Money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. There were no changes to the valuation methods during the nine months ended September 30, 2022.The Company evaluates transfers between levels at the end of each reporting period. There were no transfers between levels during the nine months ended September 30, 2022.

4. Property and Equipment, Net

Property and equipment, net consisted of the following (in thousands):

	SEPTEMBER 30,			DECEMBER 31,
	2022			2021
Machinery and equipment	$	6,728		$	6,659
Leasehold improvements		579			579
Furniture and fixtures		319			319
	$	7,626		$	7,557
Less: Accumulated depreciation and amortization		(5,105	)		(4,511	)
	$	2,521		$	3,046

Depreciation and amortization expense for each of the three months ended September 30, 2022 and 2021 was $0.3 million. Depreciation and amortization expense for the nine months ended September 30, 2022 and 2021 was $0.8 million and $0.9 million, respectively.

5. Accrued Expenses

Accrued expenses consisted of the following (in thousands):

	SEPTEMBER 30,		DECEMBER 31,
	2022		2021
Accrued external research, development and manufacturing costs	$	2,728	$	2,156
Accrued employee compensation and benefits		3,540		3,040
Other		1,555		1,614
	$	7,823	$	6,810

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6. Stock-Based Compensation

The following table summarizes the Company’s stock option activity since December 31, 2021:

	NUMBER OF SHARES			WEIGHTED- AVERAGE EXERCISE PRICE		WEIGHTED- AVERAGE REMAINING CONTRACTUAL TERM		INTRINSIC VALUE
						(in years)		(in thousands)
Outstanding at December 31, 2021		4,339,523		$	9.75		7.68	$	8,823
Granted		2,541,920			5.75
Exercised		(14,757	)		1.95
Forfeited or canceled		(260,186	)		10.63
Outstanding at September 30, 2022		6,606,500		$	8.19		7.69	$	169
Vested and expected to vest at September 30, 2022		6,606,500		$	8.19		7.69	$	169
Options exercisable at September 30, 2022		2,825,300		$	7.97		5.94	$	169

Stock-Based Compensation Expense

Stock-based compensation expense related to stock options was classified in the consolidated statements of operations as follows (in thousands):

	THREE MONTHS ENDED SEPTEMBER 30,				NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021		2022		2021
Research and development expenses	$	1,034	$	1,423	$	2,563	$	2,670
General and administrative expenses		1,342		1,358		4,067		3,523
	$	2,376	$	2,781	$	6,630	$	6,193

As of September 30, 2022, total unrecognized stock-based compensation expense related to unvested stock-based awards was $19.3 million, which is expected to be recognized over a weighted-average period of 2.7 years.

7. Income Taxes

For the three and nine months ended September 30, 2022 and 2021, the Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period, due to its uncertainty of realizing a benefit from those items. Substantially all of the Company’s operating losses since inception have been generated in the United States.

8. Commitments and Contingencies

Leases

The Company’s commitments under its leases are described in Note 9.

License and Supply Agreements

License Agreement with Massachusetts Institute of Technology

In December 2015, the Company entered into an exclusive patent license agreement with the Massachusetts Institute of Technology (“MIT”) (the “MIT Agreement”). The MIT Agreement replaced a May 2013 exclusive agreement with MIT. Under the MIT Agreement, the Company received an exclusive license under the licensed patent rights to develop, manufacture and commercialize any products related to certain intracellular delivery methods that were developed at MIT.

As of September 30, 2022 and December 31, 2021, the Company had no outstanding liabilities related to the MIT Agreement. During each of the three and nine months ended September 30, 2022 and 2021, the Company did not recognize any research and development expense under the sublicense terms of the MIT Agreement.

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Manufacturing Services Agreements

The Company has entered into agreements with a contract manufacturing organization to provide manufacturing services related to its product candidates. As of September 30, 2022, the Company had no non-cancelable payments under these agreements, as amended, other than the amounts included in the current portion of operating lease liabilities on the Company's consolidated balance sheets.

401(k) Plan

The Company sponsors a 401(k) defined contribution benefit plan (the “401(k) Plan”), which covers all employees who meet certain eligibility requirements as defined in the 401(k) Plan and allows participants to defer a portion of their annual compensation on a pre-tax basis. Contributions to the 401(k) Plan may be made at the discretion of management. For the three months ended September 30, 2022 and 2021, the Company contributed $0.3 million and $0.1 million, respectively to the 401(k) Plan. For the nine months ended September 30, 2022 and 2021, the Company contributed $0.5 million and $0.2 million, respectively to the 401(k) Plan.

Indemnification Agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to its vendors, lessors, contract research organizations, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with its executive officers and members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or executive officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. The Company has not incurred any material costs as a result of such indemnification agreements and is not currently aware of any indemnification claims.

Legal Proceedings

The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings.

9. Leases

As of September 30, 2022, the Company leases its office and laboratory facilities under a non-cancelable operating lease entered into in December 2018, which included lease incentives, payment escalations and rent holidays. In addition, the Company has an agreement entered into in April 2019 with a contract manufacturing supplier that is considered an embedded lease because the Company has substantially all the economic benefits of the related asset and can direct its use. The Company had not entered into any financing leases or any short-term operating leases as of September 30, 2022 and December 31, 2021.

The components of lease cost and other information for the Company’s lease portfolio were as follows (in thousands, except term and discount rate amounts):

	THREE MONTHS ENDED SEPTEMBER 30,				NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021		2022		2021
Lease cost:
Operating lease cost	$	3,347	$	3,430	$	10,867	$	9,965
Variable lease cost		454		425		1,424		1,428
	$	3,801	$	3,855	$	12,291	$	11,393

	SEPTEMBER 30, 2022			DECEMBER 31, 2021
Other information:
Weighted-average remaining lease term (in years)		5.5			6.2
Weighted-average discount rate		7.6	%		7.6	%

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Supplemental cash flow information related to the Company’s operating leases was as follows (in thousands):

	NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021
Cash paid for amounts included in the measurement of operating lease liabilities:
Operating cash flows from operating leases	$	11,060	$	9,424

10. License and Collaboration Agreements

2017 License and Collaboration Agreement with Roche

In April 2017, the Company entered into a second license and collaboration agreement with Roche (the “2017 Roche Agreement”) to allow Roche to use the Company’s Cell Squeeze technology to enable gene editing of immune cells to discover new targets in cancer immunotherapy. The 2017 Roche Agreement included several licenses granted by Roche to the Company and by the Company to Roche in order to conduct a specified research program in accordance with a specified research plan. In the first quarter of 2022, the 2017 Roche Agreement was terminated and all active work streams under the 2017 Roche Agreement were concluded. As of December 31, 2021, the Company determined that it expected to incur no additional costs to satisfy the remaining performance obligations under the 2017 Roche Agreement and all remaining deferred revenue was recognized as of that date. There was no revenue recorded under this agreement during the three and nine months ended September 30, 2022.

During the three and nine months ended September 30, 2021, the total costs expected to be incurred to satisfy the performance obligation under the 2017 Roche Agreement decreased by $0.1 million and $0.4 million, respectively. The Company recognized revenue of $0.3 million and $1.0 million during the three and nine months ended September 30, 2021, respectively.

2018 License and Collaboration Agreement with Roche

In October 2018, the Company entered into a license and collaboration agreement with Roche (the “2018 Roche Agreement”) to jointly develop certain products based on mononuclear antigen presenting cells (“APCs”), including human papillomavirus (“HPV”), using the SQZ APC platform for the treatment of oncology indications. The Company granted Roche a non-exclusive license to its intellectual property, and Roche granted the Company a non-exclusive license to its and its affiliates’ intellectual property for the purpose of performing research activities. In connection with this agreement, the parties terminated an earlier agreement. The 2018 Roche Agreement has a term that extends until all royalty, profit-share and other payment obligations expire or have been satisfied. Roche has the right to terminate the 2018 Roche Agreement, in whole or on a product-by-product basis, upon a specified amount of notice to the Company. The Company or Roche may terminate the agreement if the other party fails to cure its material breach within a specified period after receiving notice of such breach.

Under the 2018 Roche Agreement, Roche was granted option rights to obtain an exclusive license to develop APC products or products derived from the collaboration programs on a product-by-product basis. These option rights are exercisable upon the achievement of clinical Phase 1 proof of concept and expire, if unexercised, as of a date specified in the agreement. In addition, Roche was granted an option right to obtain an exclusive license to develop a Tumor Cell Lysate (“TCL”) product. This option right is exercisable upon the achievement of clinical proof of concept and expires, if unexercised, as of a date specified in the agreement. For each of the APC products and TCL product, once Roche exercises its option and pays a specified incremental amount ranging from $15.0 million to $50.0 million for APC products and of $100.0 million for the TCL product, Roche will receive worldwide, exclusive commercialization rights for the licensed products, subject to the Company’s alternating option to retain U.S. APC commercialization rights. The Company will retain worldwide commercialization rights to any APC products or the TCL product for which Roche elects not to exercise its applicable option. For the first APC product that Roche exercises its option, Roche will receive worldwide, exclusive commercialization rights for the licensed product. On a product-by-product basis for the APC products, after the first product option is exercised by Roche and for every other product for which Roche exercises its option, the Company will retain an option to obtain the exclusive commercialization rights in the United States. Upon exercise of the TCL option by Roche, (i) the Company will be entitled to receive the aforementioned milestone payment of $100.0 million and (ii) profits from the TCL product will be shared equally by the Company and Roche. Through September 30, 2022, Roche had not exercised any of its options under the 2018 Roche Agreement.

Under the 2018 Roche Agreement, the Company received an upfront payment of $45.0 million and is eligible to receive (i) reimbursement of a mid-double-digit percentage of its development costs; (ii) aggregate milestone payments on a product-by-product basis of up to $1.6 billion upon the achievement of specified milestones, consisting of up to $217.0 million of development milestone payments, up to $240.0 million of regulatory milestone payments and up to $1.2 billion of sales milestone payments; and (iii) tiered royalties on annual net sales of APC and TCL products licensed under the agreement, as described below. The Company received the upfront payment of $45.0 million in October 2018 upon execution of the agreement. In addition, during the second quarter of 2019, the

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Company received a payment of $10.0 million following the achievement of the first development milestone under the 2018 Roche Agreement related to submission by the Company of preclinical data to the U.S. Food and Drug Administration (“FDA”). During the first quarter of 2020, the Company received a payment of $20.0 million following the achievement of the second development milestone under the 2018 Roche Agreement related to first-patient dosing in a Phase 1 clinical trial. In the first quarter of 2022, the Company received a milestone payment of $3.0 million having achieved in the fourth quarter of 2021 the following: (i) the endorsement by an independent panel that it could advance its SQZ-PBMC-HPV clinical trial to combination therapy using checkpoint inhibitors and (ii) the initiation of that therapy.

Roche will pay tiered royalties based on annual net sales of APC and TCL products. If Roche exercises its option to obtain a license to commercialize an APC product, Roche will pay the Company tiered royalties on annual net sales of that licensed product at rates ranging from a mid-single-digit percentage to a mid-teens percentage, depending on net sales of the product. If the Company exercises its option to obtain a license to commercialize an APC product in the United States, it will pay Roche tiered royalties on annual net sales of that licensed product at rates ranging from a mid-single-digit percentage to a mid-teens percentage, depending on net sales of the product in the United States. For APC products selected by Roche, rather than mutually, Roche will pay the Company royalties on annual net sales of that licensed product at rates ranging from a mid-single-digit percentage to a high single-digit percentage, depending on net sales of the product. For APC products that are selected mutually and for which the Company has not exercised its option to commercialize the product in the United States, Roche will pay the Company tiered royalties on annual net sales of that licensed product at a rate ranging from a high single-digit percentage to a mid-teens percentage, depending on net sales of the product. For TCL products, Roche will pay the Company tiered royalties on the aggregate net sales of all TCL products at rates ranging from either a mid-single digit percentage to a percentage in the low twenties, with the caveat that the rates for sales in the United States may instead range from a low-teens percentage to a percentage in the mid-twenties, depending on whether and when the Company opts out of sharing certain profits and costs of commercializing the TCL product in the United States with Roche.

The Company identified three performance obligations at the outset of the 2018 Roche Agreement: (1) the license to the Company’s intellectual property, the research and development activities related to HPV through Phase 1 clinical trials under a specified research plan, and the manufacturing of the Company’s SQZ APC platform and equipment in order to support the HPV research plan (the “first performance obligation”); (2) the license to the Company’s intellectual property and the research and development activities on next-generation APCs (the “second performance obligation”); and (3) the license to the Company’s intellectual property and the research and development activities on TCL (the “third performance obligation”).

During the fourth quarter of 2019, the Company evaluated its overall program priorities and determined that it would continue to focus its resources on progressing the specified APC programs related to the 2018 Roche Agreement as well as its Activating Antigen Carriers (“AAC”) and Tolerizing Antigen Carriers (“TAC”) platforms. As a result of its continuing focus on these specific programs, the Company reduced the level of priority of the TCL research activities under the 2018 Roche Agreement and expects to perform such TCL research activities over a longer time period than as originally expected under the specified research plan of the agreement. Since the fourth quarter of 2019, the Company has classified $9.2 million as non-current deferred revenue, which will remain unrecognized as revenue until TCL research activities resume or the 2018 Roche Agreement is modified by the Company and Roche.

The Company separately recognizes revenue associated with each of the three performance obligations as the research, development and manufacturing services are provided using an input method, based on the cumulative costs incurred compared to the total estimated costs expected to be incurred to satisfy each performance obligation. The transfer of control to the customer occurs over the time period that the research and development services are to be provided by the Company, and this cost-to-cost method is, in management’s judgment, the best measure of progress towards satisfying each performance obligation. The amounts received that have not yet been recognized as revenue are deferred as a contract liability in the Company’s consolidated balance sheet and will be recognized over the remaining research and development period until each performance obligation is satisfied.

During the three and nine months ended September 30, 2022, there were no significant changes in the total estimated costs expected to be incurred to satisfy the performance obligations under the 2018 Roche Agreement. During the three and nine months ended September 30, 2021, the estimated costs expected to be incurred to satisfy the performance obligations increased by $0.4 million. The Company recognized revenue of $3.1 million and $4.5 million during the three months ended September 30, 2022 and 2021, respectively, under this agreement. The Company recognized revenue of $9.0 million and $13.6 million during the nine months ended September 30, 2022 and 2021, respectively, under this agreement. As of September 30, 2022, the Company recorded as a contract liability deferred revenue related to the 2018 Roche Agreement of $12.2 million, of which $3.0 million was a current liability. As of September 30, 2022, the research and development services related to the performance obligations were expected to be performed over a remaining period of three months. As of December 31, 2021, the Company recorded as a contract liability deferred revenue related to the 2018 Roche Agreement of $21.2 million, of which $12.0 million was a current liability.

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As of September 30, 2022 and December 31, 2021, the expected remaining period of performance of the Company’s research and development services related to the third performance obligation was not determinable, and it will not become determinable until TCL research activities resume or the 2018 Roche Agreement is modified by the Company and Roche.

Contract Liability

The changes in the total contract liability (deferred revenue) balances related to the Company’s license and collaboration agreements were as follows (in thousands):

	THREE MONTHS ENDED SEPTEMBER 30,						NINE MONTHS ENDED SEPTEMBER 30,
	2022			2021			2022			2021
Balance at beginning of period	$	15,326		$	35,308		$	21,203		$	45,201
Recognition of deferred revenue		(3,130	)		(4,755	)		(9,011	)		(14,748	)
Other		—			—			4			100
Balance at end of period	$	12,196		$	30,553		$	12,196		$	30,553

11. Net Loss per Share

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):

	THREE MONTHS ENDED SEPTEMBER 30,						NINE MONTHS ENDED SEPTEMBER 30,
	2022			2021			2022			2021
Numerator:
Net loss	$	(22,643	)	$	(22,450	)	$	(65,917	)	$	(56,919	)
Denominator:
Weighted-average common shares outstanding, basic and    diluted		29,284,151			28,050,130			28,603,020			27,421,839
Net loss per share attributable to common stockholders, basic and    diluted	$	(0.77	)	$	(0.80	)	$	(2.30	)	$	(2.08	)

The Company’s potential dilutive securities, which consist of common stock options have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

	THREE MONTHS ENDED SEPTEMBER 30,				NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021		2022		2021
Stock options to purchase common stock		6,606,500		4,527,642		6,606,500		4,527,642
		6,606,500		4,527,642		6,606,500		4,527,642

12. Subsequent Event

On November 1, 2022, as part of a transition to a more cost-effective manufacturing format, the Company provided notice to terminate its agreement with the contract manufacturing supplier referred to in Note 9, Leases. The agreement requires a nine-month prior written notice of termination, which results in an estimated termination date of July 31, 2023. As a result of the termination, the Company reduced its remaining lease payments by approximately $36.7 million. The termination will be accounted for as a lease modification in the three months ending December 31, 2022. The Company estimates the modification will reduce the right of use asset and lease liability by approximately $31.5 million.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission, or SEC, on March 16, 2022 (the “2021 Form 10-K”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of our 2021 Form 10-K and this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We are a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies to benefit patients with cancer, autoimmune and infectious diseases, and other serious conditions. The company was founded on the therapeutic potential of Cell Squeeze® technology, our proprietary technology which allows for rapid delivery of a variety of cargo into different cell types. We aim to create multiple cell therapies that drive the immune system to combat diseases.

In oncology, we are developing cell therapy platforms that are based on directing tumor antigen-specific immune activation via engineered antigen presentation. We believe that by engineering physiological antigen presentation signals in subsets of peripheral blood cells that act on immune priming pathways, we have the potential to develop cell therapies that are designed to be potent drivers of tumor-specific immunity, well-tolerated, administered without lymphodepleting preconditioning or hospitalization, and produced in under 24 hours. We have three oncology candidates in clinical trials across our SQZ® Antigen Presenting Cell, or APC, SQZ® enhanced APC, or eAPC, and SQZ® Activating Antigen Carrier, or AAC, cell therapy platforms. In our autoimmune diseases portfolio, we are developing our SQZ® Tolerizing Antigen Carrier, or TAC, cell therapy platform with the aim to restore immune tolerance to self-antigens or other autoimmune disease-associated antigens that are central to disease pathogenesis.

In 2021, we executed on several key areas of our pipeline and advanced our APC platform objectives. As of December 31, 2021, we have dosed 20 patients in our Phase 1 trial for our lead APC candidate, SQZ-PBMC-HPV, in HPV16+ advanced solid tumors. We reported interim data from the first three monotherapy dose-escalation cohorts at the 2021 American Society of Clinical Oncology, or ASCO, Annual Meeting, and presented interim safety, biomarker, and clinical data from the highest dose SQZ-PBMC-HPV monotherapy cohort at the 2021 European Society for Medical Oncology Immuno-Oncology, or ESMO-IO, Congress. Key observations from the reported data include, as of a cutoff date of October 8, 2021 (n=18 patients):

•SQZ-PBMC-HPV induced a radiographic response and led to symptomatic improvement as a monotherapy treatment in a checkpoint refractory head-and-neck cancer patient

•Across all dose levels, there were no observed treatment-related Grade 3 or greater serious adverse events, and no patient met the dose limiting toxicity, or DLT, criteria

•Autologous cell therapy manufacturing was demonstrated in under 24 hours for all monotherapy patients, with multiple doses produced and an average vein-to-vein time of approximately one week

Although clinical enrollment has remained challenging across our clinical trials, we have advanced our trial to evaluate SQZ-PBMC-HPV in combination with checkpoint inhibitor therapies. In April 2022, the U.S. Food and Drug Administration, or FDA, granted Fast Track Designation to SQZ-PBMC-HPV for the treatment of HPV16+ advanced or metastatic solid tumors. We are targeting initial interim data for patients in combination with checkpoint inhibitors by the end of 2022. Additionally, we are continuing to enroll patients in the highest dose monotherapy cohort and are targeting additional monotherapy data by the end of 2022.

We have continued to build upon the progress of our SQZ® APC platform through the development of the novel SQZ® eAPC platform. Our lead eAPC product candidate leverages the added capabilities and functionality of multiple antigen presentation and immunological signals achieved through multiplexed mRNA delivery to diverse immune cell types. In January 2022, we received allowance to proceed with clinical trials from the FDA under our Investigational New Drug, or IND, application for SQZ-eAPC-HPV, our lead eAPC candidate engineered with HPV16 antigens and costimulatory signals. We initiated the SQZ-eAPC-HPV trial, the COMMANDER-001 Phase 1/2 study, in patients with HPV16+ advanced solid tumors in the first half of 2022. We anticipate announcing initial cohort 1 data by the end of 2022.

In 2021, we received allowance to proceed with clinical trials from the FDA under our IND for SQZ-AAC-HPV, our lead AAC product candidate derived from red blood cells engineered with tumor-specific antigens. We are currently enrolling monotherapy cohorts as part of the Phase 1 ENVOY-001 trial to assess safety and tolerability as well as secondary outcome measures of the investigational SQZ-AAC-HPV therapy in HPV16+ advanced solid tumors, and plan to announce initial interim safety data for a limited number of patients by the end of 2022.

We are also advancing our SQZ® TAC platform focused on creating novel and proprietary cell therapies as it relates to modulating or restoring immune tolerance. We have selected Celiac disease as the first proposed autoimmune indication for SQZ® TAC platform

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development. We believe the evidence of a causal disease antigen and T-cell driven pathology, and the substantial unmet need for a tolerizing treatment option provide a compelling opportunity for us to pursue Celiac disease. We presented characterization of TAC-mediated mechanisms of antigen-specific tolerance in preclinical models at the 2021 Federation of Clinical Immunology Societies, or FOCIS, Meeting. We anticipate further development of our TAC-Celiac candidate through IND-enabling studies in 2022 to support an IND submission in the first half of 2023, and, in parallel, are planning to use our proprietary, point-of-care manufacturing system for the production of the clinical batches.

As we continue to develop our point-of-care manufacturing system we are also evaluating the capacity to utilize the system to reduce manufacturing-related costs for our other therapeutic product candidates. Furthermore, we are evaluating the possibility of allowing access to the Cell Squeeze® technology, associated methods and clinical-scale systems for manufacturing uses together with third-parties.

Since our inception, we have focused substantially all of our resources on building our Cell Squeeze technology, establishing and protecting our intellectual property portfolio, conducting research and development activities, developing our manufacturing process and manufacturing product candidate materials, preparing for and initiating clinical trials of our product candidates, organizing and staffing our company, business planning, raising capital and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any revenue from product sales. Through September 30, 2022, we have funded our operations primarily with upfront and milestone payments received under our collaboration agreements with Hoffman La Roche Inc. and F. Hoffman La Roche Ltd. (together, "Roche",) and with proceeds from equity and debt offerings, most recently from our initial public offering, or IPO, and follow-on public offering of common stock, or the Follow-on Offering. During the nine months ended September 30, 2022, we raised $3.7 million in net proceeds, utilizing an “at-the-market” offering facility, pursuant to which we sold 1,160,768 shares of our common stock.

Since our inception, we have incurred significant operating losses. Our ability to generate any product revenue or product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our product candidates. We reported a net loss of $65.9 million for the nine months ended September 30, 2022. As of September 30, 2022, we had an accumulated deficit of $261.4 million. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. Absent significant changes to our current operating structure, we expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

•conduct clinical trials for our product candidates, including our ongoing clinical trials of SQZ-PBMC-HPV, SQZ-AAC-HPV and SQZ-eAPC-HPV, both in the United States and abroad;

•further develop our Cell Squeeze® technology;

•continue to develop additional product candidates;

•maintain, expand and protect our intellectual property portfolio;

•hire additional clinical, scientific manufacturing and commercial personnel;

•expand external and/or establish internal commercial manufacturing sources and secure supply chain capacity sufficient to provide commercial quantities of any product candidates for which we may obtain regulatory approval;

•acquire or in-license other product candidates and technologies;

•seek regulatory approvals for any product candidates that successfully complete clinical trials;

•establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain regulatory approval; and

•add operational, financial and management information systems and personnel to support our product development, clinical execution and planned future commercialization efforts, as well as to continue to support our status as a public company.

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, and distribution.

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, distribution or licensing arrangements. Currently, market conditions in the biotechnology sector are challenging due to ongoing global and economic uncertainties. Accordingly, 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 would have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates.

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Because of the numerous risks and uncertainties associated with cell therapy 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.

As of November 9, 2022, the issuance date of the interim condensed consolidated financial statements for the three and nine month periods ended September 30, 2022, included elsewhere in this Quarterly Report on Form 10-Q, based on our recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, our management has concluded that there is substantial doubt about our ability to continue as a going concern for a period of one year from the date that the condensed consolidated financial statements are issued. See “—Liquidity and Capital Resources.”

Impact of the COVID-19 Pandemic

The COVID-19 pandemic and government measures taken in response have had a significant impact, both direct and indirect, on hospitals, businesses and commerce, as worker shortages have occurred, supply chains have been disrupted, prices have increased, and the use of facilities and production have been suspended. The future progression of the pandemic and its effects on our business and operations are uncertain.

The COVID-19 pandemic has impacted and may continue to impact personnel at third-party manufacturing facilities or the availability or cost of materials, which would disrupt our supply chain. It also has affected and may continue to affect our ability to enroll patients in and timely complete our ongoing clinical trials of SQZ-PBMC-HPV, SQZ-AAC-HPV and SQZ-eAPC-HPV and delay the initiation of future clinical trials, disrupt regulatory activities or have other adverse effects on our business and operations. For example, we have experienced delays in receiving supplies of raw materials for our preclinical activities due to the impact of COVID-19 on our suppliers’ ability to timely manufacture these materials, and we have experienced an increase in the transportation cost of our product candidates due to the decreased availability of commercial flights. In addition, we have experienced delays in opening clinical trial sites and sites that are open may also have challenges enrolling patients. Further, staff shortages, including staff that are required to conduct certain testing, such as biopsies, at our clinical sites or at third-party vendors have resulted in delays in site initiations and in some tests not being properly or timely performed or being delayed. In response to the public health directives and to help reduce the risk to our employees, we took precautionary measures, including implementing work-from-home policies for our administrative employees and staggered work times for our lab employees. We plan to continue to implement restrictive measures as appropriate and continue to assess when and how to resume normal operations. The effects of the public health directives and our work-from-home policies may negatively impact productivity, disrupt our business and delay our clinical programs and timelines and future clinical trials, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, results of operations and financial condition, including our ability to obtain financing.

The pandemic and related uncertainties have already caused significant disruptions in the financial markets, and may continue to cause such disruptions, which could impact our ability to raise additional funds to support our operations. Moreover, the pandemic has significantly impacted inflation and economies worldwide and could result in adverse effects on our business and operations. We are monitoring the potential impact of the COVID-19 pandemic on our business and financial statements. To date, we have not incurred impairment losses in the carrying values of our assets as a result of the pandemic and we are not aware of any specific related event or circumstance that would require us to revise our estimates reflected in our interim condensed consolidated financial statements. We cannot be certain what the overall impact of the COVID-19 pandemic will be on our business and people. The extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations, financial condition, and liquidity, including planned and future clinical trials and research and development costs, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19, the actions taken to contain or treat it, and the duration and intensity of the related effects.

Components of Our Results of Operations

Revenue

To date, we have not generated any revenue from product sales and do not expect to do so for the next several years. All of our revenue to date has been derived from three collaboration agreements with Roche, and, to a lesser extent, from government grants.

If our development efforts for our product candidates are successful and result in regulatory approval, or in license or additional collaboration agreements with third parties, we may generate revenue in the future from product sales, payments from additional collaboration or license agreements that we may enter into with third parties, or any combination thereof. We expect that our revenue for

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the next several years will be derived primarily from our collaboration agreements with Roche as well as any additional collaborations that we may enter into in the future. We cannot provide assurance as to the timing of future milestone or royalty payments or that we will receive any of these payments at all.

Collaboration Revenue

2017 License and Collaboration Agreement with Roche

In April 2017, we entered into a second license and collaboration agreement with Roche (the “2017 Roche Agreement”) to allow Roche to use our Cell Squeeze® technology to enable gene editing of immune cells to discover new targets in cancer immunotherapy. The 2017 Roche Agreement included several licenses granted by Roche to us and by us to Roche in order to conduct a specified research program in accordance with a specified research plan. In the first quarter of 2022, the 2017 Roche Agreement was terminated and all active work streams under the 2017 Roche Agreement were concluded. As of December 31, 2021, we had determined that we expected to incur no additional costs to satisfy the remaining performance obligations under the 2017 Roche Agreement and all remaining deferred revenue was recognized as of that date. There was no revenue recorded under this agreement during the three and nine months ended September 30, 2022.

During the three and nine months ended September 30, 2021, the total costs expected to be incurred to satisfy the performance obligation under the 2017 Roche Agreement decreased by $0.1 million and $0.4 million, respectively. We recognized revenue of $0.3 million and $1.0 million during the three and nine months ended September 30, 2021, respectively.

2018 License and Collaboration Agreement with Roche

In October 2018, we entered into a license and collaboration agreement with Roche, or the 2018 Roche Agreement, to jointly develop certain products based on mononuclear antigen presenting cells, or APCs, including human papillomavirus, or HPV, using our SQZ APC platform for the treatment of oncology indications. We granted Roche a non-exclusive license to our intellectual property, and Roche granted us a non-exclusive license to its and its affiliates’ intellectual property for the purpose of performing research activities. In connection with this agreement, the parties terminated an earlier agreement.

Under the 2018 Roche Agreement, Roche was granted option rights to obtain an exclusive license to develop APC products or products derived from the collaboration programs on a product-by-product basis and to develop a Tumor Cell Lysate, or TCL, product. For each of the APC products and TCL product, once Roche exercises its option and pays a specified incremental amount, Roche will receive worldwide, exclusive commercialization rights for the licensed products. Through September 30, 2022, Roche had not exercised any of its options under the 2018 Roche Agreement.

Under the 2018 Roche Agreement, we received an upfront payment of $45.0 million and are eligible to receive (i) reimbursement of a mid-double-digit percentage of our development costs; (ii) aggregate milestone payments on a product-by-product basis of up to $1.6 billion upon the achievement of specified milestones, consisting of up to $217.0 million of development milestone payments, up to $240.0 million of regulatory milestone payments and up to $1.2 billion of sales milestone payments; and (iii) tiered royalties on annual net sales of APC and TCL products licensed under the agreement at specified rates ranging from a mid-single-digit percentage to a percentage in the mid-twenties. We received the upfront payment of $45.0 million in October 2018 upon execution of the agreement. In addition, during the second quarter of 2019, we received a payment of $10.0 million following the achievement of the first development milestone under the 2018 Roche Agreement related to submission by us of preclinical data to the FDA. During the first quarter of 2020, we received a payment of $20.0 million following the achievement of the second development milestone under the 2018 Roche Agreement related to first-patient dosing in a Phase 1 clinical trial. In the first quarter of 2022, we received a milestone payment of $3.0 million having achieved in the fourth quarter of 2021 the following: (i) the endorsement by an independent panel that we could advance our SQZ-PBMC-HPV clinical trial to combination therapy using checkpoint inhibitors and (ii) the initiation of that therapy.

We identified three performance obligations at the outset of the 2018 Roche Agreement: (1) the license to our intellectual property, the research and development activities related to HPV through Phase 1 clinical trials under a specified research plan, and the manufacturing of our SQZ APC platform and equipment in order to support the HPV research plan (the “first performance obligation”); (2) the license to our intellectual property and the research and development activities on next-generation APCs (the “second performance obligation”); and (3) the license to our intellectual property and the research and development activities on TCL (the “third performance obligation”).

In addition, we determined that the upfront payment of $45.0 million as well as the reimbursable costs of $10.8 million estimated by us constituted the entirety of the consideration to be included in the transaction price. This transaction price of $55.8 million was initially allocated to the three performance obligations based on the relative standalone selling price of each obligation. The potential milestone payments that we may be eligible to receive were excluded from the transaction price at the outset of the arrangement. We reevaluate the

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transaction price at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur, and, if necessary, we will adjust our estimate of the transaction price.

We separately recognize revenue associated with each of the three performance obligations as the research, development and manufacturing services are provided using an input method, based on the cumulative costs incurred compared to the total estimated costs expected to be incurred to satisfy each performance obligation. The amounts received from Roche that have not yet been recognized as revenue are deferred as a contract liability in our consolidated balance sheet and will be recognized over the remaining research and development period until each performance obligation is satisfied.

During the fourth quarter of 2019, we evaluated our overall program priorities and determined that we would continue to focus our resources on progressing the specified APC programs related to the 2018 Roche Agreement as well as our SQZ AAC and SQZ TAC platforms. As a result of our continuing focus on these specific programs, we reduced the level of priority of the TCL research activities under the 2018 Roche Agreement and expect to perform such TCL research activities over a longer time period than as originally expected under the specified research plan of the agreement. Since the fourth quarter of 2019, we have classified $9.2 million as non-current deferred revenue, which will remain unrecognized as revenue until TCL research activities resume or the 2018 Roche Agreement is modified by us and Roche.

During the three and nine months ended September 30, 2022, there were no significant changes in the total estimated costs expected to be incurred to satisfy the performance obligations under the 2018 Roche Agreement. During the three and nine months ended September 30, 2021, the estimated costs expected to be incurred to satisfy the performance obligations under the 2018 Roche Agreement increased by $0.4 million. We recognized revenue of $3.1 million and $4.5 million during the three months ended September 30, 2022 and 2021, respectively, under this agreement. We recognized revenue of $9.0 million and $13.6 million during the nine months ended September 30, 2022 and 2021, respectively, under this agreement. As of September 30, 2022, we recorded as a contract liability deferred revenue related to the 2018 Roche Agreement of $12.2 million, of which $3.0 million was a current liability. As of September 30, 2022, the research and development services related to the performance obligations were expected to be performed over a remaining period of three months.

As of September 30, 2022, the expected remaining period of performance of our research and development services related to the third performance obligation was not determinable, and it will not become determinable until TCL research activities resume or the 2018 Roche Agreement is modified by us and Roche.

Grant Revenue

We generate revenue from a government contract with the National Institutes of Health (NIH), which reimburses us for certain allowable costs for funded projects, plus an agreed upon fee. Revenue from government grants is recognized as the qualifying expenses related to the contracts are incurred, provided that there is reasonable assurance of recoverability. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded as unbilled receivables, a component of prepaid expenses and other current assets, in our consolidated balance sheet.

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including development of our product candidates and costs incurred under our collaboration arrangements with Roche, which include:

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

•expenses incurred in connection with the preclinical and clinical development of our product candidates and research programs, including under agreements with third parties, such as consultants, contractors and contract research organizations, or CROs;

•the costs of developing and scaling our manufacturing process and of manufacturing our product candidates for use in our preclinical studies and clinical trials, including the costs under agreements with third parties, such as consultants, contractors and contract manufacturing organizations, or CMOs;

•laboratory and consumable materials and research materials;

•facilities, depreciation and other expenses, which include direct and allocated expenses for rent and utilities; and

•payments made under third-party licensing agreements.

We expense research and development costs as incurred. 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. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the

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

Our direct research and development expenses are tracked on a program-by-program basis and consist of external costs and fees paid to consultants, contractors, CMOs and CROs in connection with our preclinical and clinical development and manufacturing activities. Such program costs also include the external costs of laboratory and consumable materials and costs of raw materials that are directly attributable to and incurred for any single program. We do not allocate employee costs, costs associated with our platform development and discovery efforts, payments made under third-party licensing agreements, costs of laboratory supplies and consumable materials that are not directly attributable to any single program, and facilities expenses, including rent, depreciation and other indirect costs, to specific product development programs because these costs are deployed across multiple programs and our platform technology and, as such, are not separately classified.

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. We expect that our research and development expenses will increase substantially in connection with our planned preclinical and clinical development activities in the near term and in the future, particularly should Roche determine not to exercise its options and we decide to continue clinical development of a product candidate. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates. The successful development of our product candidates is highly uncertain. This is due to the numerous risks and uncertainties associated with product development, including the following:

•the timing and progress of preclinical and clinical development activities, including geographic expansion of our clinical sites into Europe and Asia;

•the number and scope of preclinical and clinical programs we decide to pursue;

•raising additional funds necessary to complete preclinical and clinical development of our product candidates;

•the progress of the development efforts of parties with whom we have entered, or may enter, into collaboration arrangements;

•our ability to maintain our current research and development programs and to establish new ones;

•our ability to establish new licensing or collaboration arrangements;

•the successful initiation and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;

•the receipt and related terms of regulatory approvals from applicable regulatory authorities;

•the availability of specialty raw materials for use in production of our product candidates;

•our ability to consistently manufacture our product candidates for use in clinical trials;

•our ability to establish and operate a manufacturing facility, or secure manufacturing supply through relationships with third parties;

•our ability to obtain and maintain patents, trade secret protection and regulatory exclusivity, both in the United States and internationally; and

•our ability to protect our rights in our intellectual property portfolio.

A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. In addition, we may never succeed in obtaining regulatory approval for any of our product candidates.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, investor and public relations, accounting, and audit services. We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates. We also anticipate that we will incur increased 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.

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Other Income (Expense)

Interest Income

Interest income consists of interest earned on our cash equivalents balances.

Other Income (Expense), Net

Other income (expense), net consists of miscellaneous income and expense unrelated to our core operations.

Income Taxes

Since our inception, we have not recorded any income tax benefits for the net losses we have incurred in each year or for our earned research and development tax credits, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credit carryforwards will not be realized.

Results of Operations

Comparison of the Three Months Ended September 30, 2022 and 2021

The following table summarizes our results of operations for the three months ended September 30, 2022 and 2021:

	THREE MONTHS ENDED SEPTEMBER 30,
	2022	2021	CHANGE
	(in thousands)
Collaboration revenue	$3,130	$4,755	$(1,625)
Grant revenue	322	—	322
Total revenue	3,452	4,755	(1,303)
Operating expenses:
Research and development	19,631	20,520	(889)
General and administrative	6,919	6,691	228
Total operating expenses	26,550	27,211	(661)
Loss from operations	(23,098)	(22,456)	(642)
Other income (expense):
Interest income	436	8	428
Other income (expense), net	19	(2)	21
Total other income, net	455	6	449
Net loss	$(22,643)	$(22,450)	$(193)

Revenue

Collaboration revenue decreased by $1.6 million to $3.1 million for the three months ended September 30, 2022, compared to $4.8 million for the three months ended September 30, 2021. The decrease in revenue was primarily due to the following:

•an increase in the expected remaining performance period of the 2018 Roche Agreement at the end of 2021, resulting in a longer period over which revenue is recognized in 2022 as compared to the same period in 2021.

•a decrease in the number of performance obligations for which revenue is being recognized. During the three months ended September 30, 2021, we recognized revenue of $0.3 million under the 2017 Roche Agreement whereas during the three months ended September 30, 2022, we recognized no revenue under this agreement as the performance obligations were fully satisfied.

The decrease in collaboration revenue for the three months ended September 30, 2022 was partially offset by a $0.3 million increase in grant revenue. We were awarded a government grant by the NIH at the end of the first quarter of 2022 and began performing services under this grant during the second quarter of 2022.

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Research and Development Expenses

	THREE MONTHS ENDED SEPTEMBER 30,
	2022	2021	CHANGE
	(in thousands)
Direct research and development expenses by program:
SQZ-PBMC-HPV	$2,975	$4,187	$(1,212)
SQZ-AAC-HPV	2,003	895	1,108
SQZ-eAPC-HPV	3,567	6,393	(2,826)
Other programs	2,211	1,369	842
Unallocated research and development expenses:
Personnel related (including stock-based compensation)	6,336	5,317	1,019
Facility related	1,430	1,251	179
Laboratory and consumable materials	395	389	6
Platform-related external services and other	714	719	(5)
Total research and development expenses	$19,631	$20,520	$(889)

Research and development expenses decreased by $0.9 million to $19.6 million for the three months ended September 30, 2022, from $20.5 million for the three months ended September 30, 2021. The net decrease was primarily due to the following:

•SQZ-PBMC-HPV program costs decreased by $1.2 million primarily due to a decrease in allocated manufacturing costs partially offset by an increase in clinical trial costs.

•SQZ-eAPC-HPV program costs decreased by $2.8 million due to a decrease in manufacturing, materials and setup costs partially offset by an increase in allocated manufacturing costs and an increase in clinical trial-related costs.

Partially offsetting the above decreases were:

•SQZ-AAC-HPV program costs, which increased by $1.1 million primarily as a result of an increase in allocated manufacturing costs and clinical trial-related costs.

•Other program costs, which increased by $0.8 million primarily due to expenses incurred on developing a point-of-care system to manufacture our product candidates.

•Personnel-related costs, which increased by $1.0 million primarily due to a $1.4 million increase in salary and benefit costs as a result of increased headcount in our research and development function, partially offset by a $0.4 million decrease in stock-based compensation expense.

The changes in facilities, laboratory and consumable materials and platform-related external services and other costs were not significant.

General and Administrative Expenses

	THREE MONTHS ENDED SEPTEMBER 30,
	2022	2021	CHANGE
	(in thousands)
Personnel related (including stock-based compensation)	$3,780	$3,207	$573
Professional, consultant and patent related costs	1,282	1,709	(427)
Facility related and other costs	1,857	1,775	82
Total general and administrative expenses	$6,919	$6,691	$228

General and administrative expenses increased by $0.2 million during the three months ended September 30, 2022 to $6.9 million, compared to $6.7 million for the three months ended September 30, 2021. The increase was primarily due to:

•an increase of $0.6 million in personnel-related costs due to an increase in salary and benefit costs as a result of increased headcount and higher salary costs.

•a decrease of $0.4 million in professional, consultant and patent related costs due to lower legal costs incurred.

Interest Income

Interest income for the three months ended September 30, 2022 and 2021 was $0.4 million and $8 thousand, respectively. The increase in interest income was due to the increase in average interest rates during the respective periods.

Other Income (Expense), Net

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Other income (expense), net for the both the three months ended September 30, 2022 and 2021 was not significant.

Comparison of the Nine Months Ended September 30, 2022 and 2021

The following table summarizes our results of operations for the nine months ended September 30, 2022 and 2021:

	FOR THE NINE MONTHS ENDED SEPTEMBER 30,
	2022			2021			CHANGE
	(in thousands)
Revenue:
Collaboration revenue	$	9,011		$	14,748		$	(5,737	)
Grant revenue		524			—			524
Total revenue	$	9,535		$	14,748		$	(5,213	)
Operating expenses:
Research and development		55,401			52,942			2,459
General and administrative		20,789			18,744			2,045
Total operating expenses		76,190			71,686			4,504
Loss from operations		(66,655	)		(56,938	)		(9,717	)
Other income (expense):
Interest income		608			28			580
Other income (expense), net		130			(9	)		139
Total other income, net		738			19			719
Net loss	$	(65,917	)	$	(56,919	)	$	(8,998	)

Revenue

Collaboration revenue decreased by $5.7 million to $9.0 million for the nine months ended September 30, 2022, compared to $14.7 million for the three months ended September 30, 2021. The decrease in revenue was primarily due to the following:

•an increase in the expected remaining performance period of the 2018 Roche Agreement at the end of 2021, resulting in a longer period over which revenue is recognized in 2022 as compared to the same period in 2021.

•a decrease in the number of performance obligations for which revenue is being recognized. During the nine months ended September 30, 2021, we recognized revenue of $1.0 million under the 2017 Roche Agreement whereas during the nine months ended September 30, 2022, we recognized no revenue under this agreement as the performance obligations were fully satisfied.

The decrease in collaboration revenue for the nine months ended September 30, 2022 was partially offset by a $0.5 million increase in grant revenue. We were awarded a government grant by the NIH at the end of the first quarter of 2022 and began performing services under this grant during the second quarter of 2022.

Research and Development Expenses

	FOR THE NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021		CHANGE
	(in thousands)
Direct research and development expenses by program:
SQZ-PBMC-HPV	$	7,193	$	11,314	$	(4,121	)
SQZ-AAC-HPV		4,889		3,005		1,884
SQZ-eAPC-HPV		9,622		11,607		(1,985	)
Other programs		8,557		5,870		2,687
Unallocated research and development expenses:
Personnel related (including stock-based compensation)		17,604		13,991		3,613
Facility related		4,149		3,816		333
Laboratory and consumable materials		1,041		985		56
Platform-related external services and other		2,346		2,354		(8	)
Total research and development expenses	$	55,401	$	52,942	$	2,459

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Research and development expenses increased by $2.5 million to $55.4 million for the nine months ended September 30, 2022 from $52.9 million for the nine months ended September 30, 2021. The net increase was primarily due to the following:

•SQZ-AAC-HPV program costs increased by $1.9 million primarily as a result of an increase in allocated manufacturing costs and clinical trial-related costs partially offset by reduced technology transfer costs.

•Other program costs increased by $2.7 million primarily due to expenses incurred on developing a point-of-care system to manufacture our product candidates, as well as development of other platform related programs.

•Personnel-related costs increased by $3.6 million was primarily due to a $3.7 million increase in salary and benefit costs as a result of increased headcount in our research and development function, partially offset by a $0.1 million decrease in stock-based compensation expense.

•Facilities costs increased by $0.3 million due to higher operational costs.

Partially offsetting the above increases were:

•SQZ-PBMC-HPV program costs, which decreased by $4.1 million primarily due to a decrease in allocated and direct manufacturing costs, partially offset by an increase in clinical trial-related costs.

•SQZ-eAPC-HPV program costs, which decreased by $2.0 million due to a decrease in mRNA materials manufacturing costs, partially offset by an increase in allocated and direct manufacturing and clinical costs.

The changes in laboratory and consumable materials and platform-related external services and other costs were not significant.

General and Administrative Expenses

	FOR THE NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021		CHANGE
	(in thousands)
Personnel related (including stock-based compensation)	$	10,887	$	9,141	$	1,746
Professional, consultant and patent related costs		4,384		4,398		(14	)
Facility related and other costs		5,518		5,205		313
Total general and administrative expenses	$	20,789	$	18,744	$	2,045

General and administrative expenses increased by $2.1 million during the nine months ended September 30, 2022 to $20.8 million, compared to $18.7 million for the nine months ended September 30, 2021. The increase was primarily due to:

•an increase of $1.7 million in personnel-related costs due to a $1.1 million increase in salary and benefit costs as a result of increased headcount and higher salary costs and a $0.6 million increase in stock-based compensation expense.

•an increase of $0.3 million in facility related and other costs primarily due to higher operational costs.

Interest Income

Interest income for the nine months ended September 30, 2022 and 2021 was $0.6 million and $28 thousand, respectively. The increase in interest income was due to the increase in average interest rates during the respective periods.

Other Income (Expense), Net

Other income (expense), net for the nine months ended September 30, 2022 was $0.1 million. The other income of $0.1 million for the nine months ended September 30, 2022 was primarily related to a grant received from a Massachusetts economic development and investment agency. Other income (expense), net for the nine months ended September 30, 2021 was insignificant.

Liquidity and Capital Resources

Since our inception, we have incurred significant operating losses. 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 the next several years, if at all. Through September 30, 2022, we have funded our operations primarily with payments received in connection with collaboration agreements, proceeds from equity and debt financing, most recently, with proceeds from our IPO, Follow-On Offering and our at-the market offering facility with Jefferies LLC ("ATM Facility"). During the nine months ended September 30, 2022, we raised $3.7 million in net proceeds, under the ATM Facility, pursuant to which we sold 1,160,768 shares of our common stock. See Note 1 to our consolidated financial statements

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appearing elsewhere in this Quarterly Report on Form 10-Q for further information on the ATM Facility. As of September 30, 2022, we had cash and cash equivalents of $84.2 million.

Cash Flows

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

	NINE MONTHS ENDED SEPTEMBER 30,
	2022			2021
	(in thousands)
Net cash used in operating activities	$	(62,789	)	$	(61,117	)
Net cash used in investing activities		(387	)		(613	)
Net cash provided by financing activities		3,902			55,627
Net (decrease) increase in cash, cash equivalents and restricted cash	$	(59,274	)	$	(6,103	)

Operating Activities

During the nine months ended September 30, 2022, operating activities used $62.8 million of cash, primarily resulting from our net loss of $65.9 million and changes in our operating assets and liabilities of $11.8 million, partially offset by net non-cash charges of $15.0 million. Net cash used by changes in our operating assets and liabilities for the nine months ended September 30, 2022 consisted primarily of a $9.0 million decrease in deferred revenue, a $7.2 million decrease in operating lease liabilities, a $1.0 million decrease in prepaid expenses and other current assets, a $1.0 million increase in accrued expenses, all of which were partially offset by a $3.0 million decrease in accounts receivable. The decrease in deferred revenue during the nine months ended September 30, 2022 was due to the revenue we recognized in that same period under the 2018 Roche Agreement.

During the nine months ended September 30, 2021, operating activities used $61.1 million of cash, primarily resulting from our net loss of $56.9 million and changes in our operating assets and liabilities of $18.7 million, partially offset by net non-cash charges of $14.5 million. Net cash used by changes in our operating assets and liabilities for the nine months ended September 30, 2021 consisted primarily of a $14.5 million decrease in deferred revenue, a $6.8 million decrease in operating lease liabilities, a $1.4 million decrease in accrued expenses, all of which were partially offset by a $2.7 million decrease in prepaid expenses and other current assets and a $1.9 million decrease in accounts receivable. The decrease in deferred revenue during the nine months ended September 30, 2021 was due to the revenue we recognized in that same period under the 2018 Roche Agreement.

In all periods presented, other changes in prepaid expenses and other current assets, accounts receivable, accounts payable, accrued expenses and other liabilities not described above were generally due to growth in our business, the advancement of our research programs and the timing of vendor invoicing and payments. In all periods presented, decreases in operating lease liabilities were primarily due to our recurring payments made under recorded operating lease liabilities, including those arising from embedded leases.

Investing Activities

During the nine months ended September 30, 2022 and 2021, net cash used in investing activities was $0.4 million and $0.6 million, respectively, consisting of purchases of property and equipment.

The purchases of property and equipment in each period were primarily for equipment purchases and leasehold improvements related to the expansion of our research and development activities and the growth of our business.

Financing Activities

During the nine months ended September 30, 2022, net cash provided by financing activities was $3.9 million consisting of proceeds from the ATM Facility, employee stock purchase plan issuances, and stock option exercises during the period.

During the nine months ended September 30, 2021, net cash provided by financing activities was $55.6 million, consisting of net proceeds from the Follow-on Offering in February 2021, of $56.4 million, in addition to proceeds of $1.1 million from stock option exercises during the period, offset by the payment of $1.9 million of IPO and Follow-on Offering costs.

Funding Requirements

Absent significant changes to our current operating structure, we expect that our expenses will increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials for our product candidates in development. The timing and amount of our operating and capital expenditures will depend largely on:

•the timing and progress of preclinical and clinical development activities, including geographic expansion of our clinical sites into Europe and Asia;

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•the commencement, enrollment or results of the planned clinical trials of our product candidates or any future clinical trials we may conduct, or changes in the development status of our product candidates;

•the timing and outcome of regulatory review of our product candidates;

•our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial as well as Roche’s decision whether to exercise its options;

•changes in laws or regulations applicable to our product candidates, including but not limited to clinical trial requirements for approvals;

•adverse developments concerning our manufacturers and other third-party providers;

•our ability to obtain materials to produce adequate product supply for any approved product or inability to do so at acceptable prices;

•our ability to establish collaborations if needed;

•the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we obtain marketing approval;

•the legal patent costs involved in prosecuting patent applications and enforcing patent claims and other intellectual property claims;

•additions or departures of key scientific or management personnel;

•unanticipated serious safety concerns related to the use of our product candidates;

•the terms and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments thereunder; and

•the severity, duration and impact of the COVID-19 pandemic and macroeconomic conditions, which may adversely impact our business.

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. To the extent that we raise additional capital through the sale of equity or convertible debt securities, existing stockholders' interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. 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 technologies, 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, including due to adverse macroeconomic conditions such as rising interest rates, we would be required to delay, scale back or discontinue 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.

As of September 30, 2022, we had an accumulated deficit of $261.4 million. During the nine months ended September 30, 2022, we recorded a net loss of $65.9 million. In addition, during the nine months ended September 30, 2022 we used $63.2 million in operating and investing activities resulting in a cash and cash equivalents balance of $84.2 million as of September 30, 2022. We expect that our operating losses and negative cash flows will continue for the foreseeable future. Based on our currently forecasted operating plan, we believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2023, but not for more than one year after the date that the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued. Therefore, based on our recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, as of November 9, 2022, the issuance date of these interim condensed consolidated financial statements for the three and nine months ended September 30, 2022, included elsewhere in this Quarterly Report on Form 10-Q, management has concluded that there is substantial doubt about our ability to continue as a going concern for a period of one year from the date that the condensed consolidated financial statements are issued. We are developing plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or debt financings, and/or potentially new collaborations, business transactions and reducing cash expenditures. If we are not able to secure adequate additional funding, we plan to make significant reductions in spending. In that event, we may have to delay, scale back, or eliminate some or all of our research and development programs and technology platform activities which could adversely affect our business prospects, or we may be unable to continue operations.

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Contractual Obligations and Commitments

There have been no material changes to our contractual obligations from those described in our 2021 Form 10-K. For additional information, see Note 8 and 9 to our condensed consolidated financial statements appearing in this Quarterly Report on Form 10-Q.

Critical Accounting Policies and Significant Judgments and Estimates

Our financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures. 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 Significant Judgments and Estimates” in our 2021 Form 10-K. If actual results or events differ materially from the estimates, judgments and assumptions used by us in applying these policies, our reported financial condition and results of operations could be materially affected. There have been no significant changes to our critical accounting policies from those described in the 2021 Form 10-K.

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

Emerging Growth Company Status

The Jumpstart Our Business Startups Act of 2012 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 not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised 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. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

As of September 30, 2022, we had cash and cash equivalents of $84.2 million, which consisted of cash and money market funds. Interest income is sensitive to changes in the general level of interest rates; however, due to the nature of these balances, an immediate 10% change in interest rates would not have a material effect on the fair market value of our cash and cash equivalents.

We are not currently exposed to significant market risk related to changes in interest rates or foreign currency exchange rates. Our operations may be subject to fluctuations in foreign currency exchange rates in the future.

We do not believe that inflation has had a material effect on our business, financial condition, or results of operations. Our operations may be subject to inflation in the future.

Item 4. Controls and Procedures.

Limitations on Effectiveness of Controls and Procedures

Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Principal Executive Officer and Principal Financial Officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934). Based on that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2022.

Changes in Internal Control over Financial Reporting

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No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the three months ended September 30, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

We are not subject to any material legal proceedings.

Item 1A. Risk Factors.

Investing in our common stock involves a high degree of risk. In addition to the other information in this Quarterly Report on Form 10-Q, including our interim condensed consolidated financial statements and the related notes and “Management’s Discussion and Analysis of Results of Operations and Financial Condition”, you should carefully consider the factors described in the section titled “Risk Factors” in our 2021 Form 10-K. Other than as discussed below, there have been no material changes to our risk factors as previously disclosed in our 2021 Form 10-K.

We do not currently have sufficient working capital to fund our planned operations for the next twelve months and may not be able to continue as a going concern.
 

As of November 9, 2022, the issuance date of the interim condensed consolidated financial statements, included elsewhere in this Quarterly Report on Form 10-Q, our management has concluded that there is substantial doubt about our ability to continue as a going concern, as we currently do not have adequate financial resources to fund our forecasted operating costs for at least twelve months from the filing of this Quarterly Report on Form 10-Q. As of September 30, 2022, we have an accumulated deficit of $261.4 million. During the nine months ended September 30, 2022, we recorded a net loss of $65.9 million. In addition, during the nine months ended September 30, 2022 we used $63.2 million in operating and investing activities resulting in a cash and cash equivalents balance of $84.2 million as of September 30, 2022.As a result, absent significant changes to our operating structure, our existing cash resources are not expected to be sufficient to meet our anticipated needs over the next twelve months from the date hereof, and we will need to raise additional capital to continue our operations and to implement our business plan. Although we have been able to raise capital in the past primarily through debt or equity financings and strategic collaborations, there is no assurance that we will be able to obtain additional financing on favorable terms or at all.

If we raise funds from the issuance of equity securities, substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business. Further, any contracts or license arrangements we enter into to raise funds may require us to relinquish our rights to our products or technology, and we may not be able to enter into any such contracts or license arrangements on favorable terms, or at all. Additionally, our fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates, if approved. Having insufficient funds may require us to delay or scale back our development programs and other activities, revise our business plan and strategy, liquidate certain assets to remain afloat, or cease our operations altogether.

Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock, and it may be more difficult for us to obtain financing. If potential collaborators decline to do business with us or potential investors decline to participate in any future financings due to such concerns, our ability to increase our cash position may be limited. The perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.

We have prepared our condensed consolidated financial statements on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Our interim condensed consolidated financial statements included in this Quarterly Report on Form 10-Q do not include any adjustments to reflect our possible inability to continue as a going concern within one year after the issuance of such financial statements. If we are unable to continue as a going concern, you could lose all or part of your investment in our Company.

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

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Effective November 1, 2022, our Board of Directors, or Board, appointed existing director Bernard Coulie, M.D., to serve as Chair of the Board following Amy W. Schulman's decision to step down as Chair. Ms. Schulman continues to serve on the Board.

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Item 6. Exhibits.

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Exhibit Number	Description	Form	File No.	Exhibit	Filing Date	Filed/ Furnished Herewith
3.1	Restated Certificate of Incorporation of SQZ Biotechnologies Company.	8-K	001-39662	3.1	11/04/2020
3.2	Amended and Restated Bylaws of SQZ Biotechnologies Company.	S-1/A	333-249422	3.4	10/26/2020
4.1	Amended and Restated Investors’ Rights Agreement, dated as of December 19, 2019, as amended.	S-1	333-252889	4.1	02/09/2021
4.2	Specimen Stock Certificate.	S-1/A	333-249422	4.2	10/26/2020
10.1	Separation Agreement between SQZ Biotechnologies Company and Howard Bernstein, dated September 2, 2022.					*
10.2	Transition Consulting Agreement between SQZ Biotechnologies Company and Howard Bernstein, dated November 1, 2022.					*
10.3	Employment Agreement between SQZ Biotechnologies Company and Micah Zajic, dated July 7, 2022.	8-K	001-39662	10.1	07/11/2022
31.1	Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.					*
31.2	Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.					*
32.1	Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.					**
32.2	Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002					**
101.INS	Instance Document – the instance document does not appear in the Interactive Data file because its XBRL tags are embedded within the Inline XBRL document					*
101.SCH	Inline XBRL Taxonomy Extension Schema Document					*
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document					*
101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document					*
101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document					*
101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document					*

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104 Cover Page Interactive Data File (as formatted as Inline XBRL and contained in Exhibit 101) *

* Filed herewith.

** Furnished herewith.

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SIGNATURES

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

	SQZ Biotechnologies Company
Date:  November 9, 2022	By:	/s/ Armon Sharei, Ph.D.
		Armon Sharei, Ph.D.
		President and Chief Executive Officer
		(principal executive officer)

Date:  November 9, 2022	By:	/s/ Micah Zajic
		Micah Zajic
		Chief Financial Officer
		(principal financial officer)

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EX-10.1

 

Exhibit 10.1

September 2, 2022

Via Email - Personal and Confidential

Dear Howard:

This letter (the “Agreement”) summarizes the terms of your separation from employment with SQZ Biotechnologies Company (“SQZ” or the “Company”) and establishes an amicable arrangement under which you release the Company from any claims, and, in return, you receive severance pay.

1.Employment Status; Final Payments; Benefits Cessation:

(a) Employment Status: As discussed, your last day of employment with the Company shall be October 31, 2022 (the “Separation Date”). As of the Separation Date, your salary shall cease and you will no longer be entitled to the payment of a base salary, bonus or any other form of compensation, except as set forth in this Agreement. On the Separation Date, the Company shall pay to you all earned but unpaid base salary, if any, up to the Separation Date. You will receive this payment regardless of whether you execute this Agreement.

(b) Expense Reimbursement: The Company will reimburse you for appropriately documented business expenses per Company policy that you have incurred up to the Separation Date, provided that you submit all documentation of any such expenses within five days of the Separation Date and in accordance with applicable Company policy (regardless of whether you sign this Agreement).

(c) Benefits Cessation: As of the Separation Date, any entitlement you have or might have under a Company-provided benefit plan, program or practice shall terminate, except as required by law, and except for rights under the Equity Documents (defined below) and the Company’s 401(k) retirement plan. Your rights to benefits, if any, are governed by the terms of the respective benefit plans and programs. The Separation Date shall be the date of the “qualifying event” under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”). You may, upon timely completion of the required forms, continue your medical and dental insurance coverage to the extent permitted by COBRA. You will receive COBRA information under separate cover.

(d) Equity Awards: You were granted options to purchase 503,546 shares of the Company’s common stock (the “Option”) pursuant to the Company’s 2014 Stock Incentive Plan and 2020 Stock Incentive Plan (the “Plan”). Under the terms of the Plan, your stock option grant notices, and your stock option agreements (collectively, the “Equity Documents”), vesting ceases as of the Separation Date. Subject to Section 2, your rights to exercise the Option as to any vested shares will be as set forth in the Equity Documents and you acknowledge that under the Plan and except as provided herein, you must exercise your right to purchase any vested shares no later than the date that is 90 days following the Separation Date.

2. Consideration: In exchange for, and in consideration of, your execution of this Agreement, and your compliance with the terms of this Agreement, the Consulting Agreement (as defined below) and the NDA (as defined below), (i) the Company will pay to you, on or before November 15, 2022, a gross lump sum

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payment equivalent to 10/12 (83.33%) of your full target performance bonus opportunity for 2022, (ii) if you elect to receive COBRA benefits, the Company shall pay to you or on your behalf a sum equal to the Company portion of health and dental insurance premiums for the period from November 1, 2022 through December 31, 2022, and (iii) you and the Company have agreed to enter into the Transition Consulting Agreement (“Consulting Agreement”) attached hereto as Exhibit A. In connection therewith, notwithstanding Section 1(d) of this Agreement, you and the Company have agreed, subject to approval by the Company’s Board of Directors (“Board Approval”), that the Option will continue to vest during the term of the Consulting Agreement or other qualifying services to the Company (it being agreed that qualifying services shall include but not be limited to any service by you on the Company’s Board of Directors), and that you may continue to exercise all of your vested Options up to 90 days after termination of the Consulting Agreement or other qualifying services to the Company. The Company acknowledges that the foregoing continued vesting and exercise terms shall apply notwithstanding any assignment of the Consulting Agreement by you to a corporation or limited liability company of which you are the majority owner so long as you (on behalf of said entity) are the person providing services under the Consulting Agreement. The Company represents that, with Board Approval, these changes to the Option are permissible under and consistent with the Plan. Your professional and timely performance of your obligations hereunder and under the Consulting Agreement is a condition of receiving the consideration set forth in this Section 2. Any lump sums will be subject to all applicable deductions and withholdings. These payments shall be made following receipt, not earlier than the Separation Date, of a fully signed version of the Certificate attached as Exhibit B.

You expressly acknowledge and agree that the payments provided to you or on your behalf under this Section 2 are benefits to which you are not otherwise entitled and are being given to you solely in exchange for your promise to be bound by the terms of this Agreement.

3. Taxes; Code Section 409A:

(a) All payments set forth in this Agreement shall be subject to all applicable federal, state and/or local withholding and/or payroll taxes, and the Company may withhold from any amounts payable to you (including any amounts payable pursuant to this Agreement) in order to comply with such withholding obligations. The Company shall undertake to make deductions, withholdings and tax reports with respect to the payments and benefits under this Agreement to the extent that it reasonably and in good faith determines that it is required to make such deductions, withholdings and tax reports. Payments under this Agreement shall be in amounts net of any such deductions or withholdings. Nothing in this Agreement shall be construed to require the Company to make any payments to compensate you for any adverse tax effect associated with any payments or benefits or for any deduction or withholding from any payment or benefit.

(b) Neither the Company nor you shall have the right to accelerate or defer the delivery of any such payments or benefits except to the extent specifically permitted or required by Section 409A of the Internal Revenue Code of 1986, as amended. The Company makes no representation or warranty and shall have no liability to you or any other person if any provision of this Agreement is determined to constitute deferred compensation subject to Section 409A, but do not satisfy an exemption from, or the conditions of, Section 409A.

4. General Release of Claims; Accord and Satisfaction:

(a) General Release: In exchange for the amounts described in Section 2, and other good and valuable consideration, the receipt of which you hereby acknowledge, you and your representatives, agents,

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estate, heirs, successors and assigns (“You”), absolutely and unconditionally hereby release, discharge, indemnify and hold harmless the Released Parties (defined in Section 4(f) below), from any and all actions or causes of action, suits, claims, complaints, contracts, liabilities, agreements, promises, torts, debts, damages, controversies, judgments, rights and demands, whether existing or contingent, known or unknown, suspected or unsuspected, arising on or before the Effective Date (the “Claims”).

This general release includes, without limitation, any and all Claims arising out of or in connection with:

(i) your employment, change in employment status, and/or termination of employment with the Company;

(ii) any federal, state or local law, constitution or regulation regarding either employment, employment benefits, or employment discrimination and/or retaliation including, without limitation, the National Labor Relations Act, as amended; Title VII of the Civil Rights Act of 1964, as amended, 42 U.S.C. 2000e etseq.; Sections 1981 through 1988 of Title 42 of the United States Code, as amended; the Employee Retirement Income Security Act of 1974, as amended, 29 U.S.C. 1001 etseq.; the Workers Adjustment and Retraining Notification Act, 29 U.S.C. Section 2101 etseq.; the Immigration Reform and Control Act, as amended; the Americans with Disabilities Act of 1990, as amended; the Family and Medical Leave Act, as amended; the Fair Labor Standards Act, as amended; the Equal Pay Act; the Occupational Safety and Health Act, as amended; the Consolidated Omnibus Budget Reconciliation Act, as amended; and laws relating to workers compensation, family and medical leave, retaliation, discrimination on the basis of race, color, religion, creed, sex, sex harassment, age, gender identity, sexual orientation, marital status, pregnancy, national origin, ancestry, handicap, disability, veteran’s status, alienage, blindness, present or past history of mental disorders or physical disability, candidacy for or activity in a general assembly or other public office, constitutionally protected acts of speech, whistleblower status, membership in any organization engaged in civil defense, veteran’s status, any military service, application for military service, or any other federal, state or local civil or human rights law or any other local, state or federal law, regulation or ordinance;

(iii) any Massachusetts state or local laws respecting employment, including but not limited to, the Massachusetts Wage Payment Act, M.G.L. c. 149 §148, the Massachusetts Minimum Fair Wages Act, M.G.L. c. 151 § 1 et. seq., the Massachusetts Fair Employment Practices Act, M.G.L. c. 151B et seq., the Massachusetts Parental Leave Law, M.G.L. c. 149, §105D, the Massachusetts Civil Rights Act, M.G.L. c. 12, §11H et seq., as amended, the Massachusetts Equal Rights Act, c. 93, §102 et seq., as amended, the Massachusetts Equal Pay Act, M.G.L. c. 149 §105A et seq., as amended, the Massachusetts law against sexual harassment, M.G.L. c. 214 §1C et seq., as amended, the Massachusetts law against retaliation, M.G.L. c. 19C, §11. et seq., as amended, the Massachusetts Privacy Statute, M.G.L. c. 214 § 1B, the Massachusetts Small Necessities Leave Act, M.G.L. c. 149, §52D, and the Massachusetts Earned Sick Time Law. Please note that this section specifically includes a waiver and release of Claims that you have or may have regarding payments or amounts covered by the Massachusetts Wage Payment Act or Massachusetts Minimum Fair Wages Act (including, for instance, hourly wages, salary, overtime, minimum wages, commissions, vacation pay, holiday pay, sick leave pay, dismissal pay, bonus pay or severance pay), as well as Claims for retaliation under these Acts;

(iv) breach of contract or breach of the implied covenant of good faith and fair dealing;

(v) claims under any Massachusetts (or any other state), federal, or local statute, regulation or executive order (as amended through the Effective Date) relating to whistleblower protections, violation of

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public policy, or any other form of retaliation or wrongful termination, or intentional or negligent infliction of emotional distress, negligent misrepresentation, intentional misrepresentation, fraud, defamation, promissory estoppel, false light invasion of privacy, conspiracy, violation of public policy; and

(vi) any other tort, statutory or common law cause of action.

(b) No Claims Through Others/Class Action Waiver: You further agree to release and discharge the Released Parties from any and all claims which might be made by any other person or organization on your behalf and you specifically waive any right to become, and promise not to become, a member of any class in a case in which a claim or claims against the Company are made involving any matters subject to release pursuant to Section 4(a).

(c) Interpretation: The foregoing general release-of-claims provisions shall be given the broadest possible interpretation permitted by law. The listing of specific claims shall not be interpreted to exclude any other claims not specifically listed therein.

(d) Accord and Satisfaction: The payments set forth in Sections 1 and 2 shall be complete and unconditional payment, settlement, accord and/or satisfaction with respect to all obligations and liabilities of the Released Parties to You including, without limitation, all claims for back wages, salary, vacation pay, sick pay, bonuses, commissions, bonuses or other incentive compensation, severance pay, any and all other forms of compensation or benefits, attorney's fees, or other costs or sums.

(e) Exclusions: Excluded from the General Release in Section 4(a) are:

(i) any claims or rights that cannot be waived by law, including your right to file a charge with the NLRB, EEOC, MCAD and/or any other government or regulatory agency, entity, or official (“Government Agencies”), or assist or participate in any agency investigation, hearing or proceeding. You, however, are waiving your right to recover money from the Released Parties regarding any such agency charge or investigation, hearing or proceeding. You also are waiving your right to recover any damages from the Released Parties in connection with a charge filed by any other individual or individuals, or by any Government Agency, on your behalf, except as permitted by applicable law. Nothing in this Agreement shall prohibit or restrict you from (1) communicating directly with, cooperating with, providing or causing to be provided information to, or otherwise assisting in an investigation by a Government Agency regarding a possible violation of any law, rule, or regulation; or (2) responding to any inquiry or legal process directed to you individually (and not directed to the Company and/or its subsidiaries) from any such Government Agency, including an inquiry about the existence of this Agreement or its underlying facts or circumstances. In addition, nothing in this Agreement shall prohibit you from making any other disclosures that are protected under the whistleblower provisions of federal law or regulations; or otherwise fully participating in any federal whistleblower programs. Further, nothing contained in this Agreement limits any right you have to receive any award for information you provide to the Securities and Exchange Commission in connection with any whistleblower action to report possible violations of securities laws. This Agreement does not require you to obtain prior authorization from the Released Parties before engaging in any conduct described in this paragraph, or to notify the Released Parties that you have engaged in any such conduct;

(ii) and any vested interests in the 401(k) retirement plans, the Plan or other employee benefit plans;

(iii) your right to enforce the terms of this Agreement;

(iv) your right to apply for unemployment compensation; and/or.

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(v) any claim for indemnification, contribution, defense or insurance coverage from or through the Company or its insurers, under the Company’s (or its affiliates’) charter or By-laws, under applicable law, or under the Company’s (or its affiliates’) insurance policies, with respect to prior actions or inactions relating in any way to Executive’s duties as an employee or officer of the Company prior to the Separation Date.

(f) Definition of Released Parties: As used in this Agreement, “Released Parties” shall mean: (i) the Company; (ii) all of the Company’s past, present, and future subsidiaries, parents, affiliates and divisions; (iii) all of the Company’s successors and/or assigns, as well as legal representatives; (iv) all of the Company’s past, present, and future officers, directors, managers, employees, shareholders, owners, attorneys, agents, insurers, employee benefit plans (including such plans’ administrators, trustees, fiduciaries, record-keepers, and insurers), and legal representatives (all individually, in their capacity acting on the Company’s behalf, and in their official capacities); and (v) all persons acting by, through, under, or in concert with any of the entities or persons listed in subsections (i)-(iv).

5.OWBPA Disclosure/Waiver of Rights and Claims Under the Age Discrimination in Employment Act: Because you are 40 years of age or older, you hereby are informed that you have or might have specific rights and/or claims under the Age Discrimination and Employment Act of 1967 (the “ADEA”), and you agree and understand that:

(a)In consideration for the amounts described in Section 2, which you are not otherwise entitled to receive, as set forth in Section 4, you specifically waive such rights and/or claims under the ADEA to the extent that such rights and/or claims arose prior to or on the date this Agreement was executed;

(b)You understand that rights or claims under the ADEA which may arise after the date this Agreement is executed are not waived by you;

(c)You acknowledge that you have been advised that you should consult with your counsel of choice prior to executing this Agreement, that you have twenty-one (21) days to review this Agreement and consider its terms before signing it, and such 21-day review period will not be affected or extended by any revisions, whether material or immaterial, that might be made to this Agreement, and that you have not been subject to any undue or improper influence interfering with the exercise of your free will in deciding whether to consult with counsel;

(d)You carefully have read and fully understand all of the provisions of this Agreement, you knowingly and voluntarily agree to all of the terms set forth in this Agreement, and you acknowledge that in entering into this Agreement, you are not relying on any representation, promise or inducement made by the Company or its representatives with the exception of those promises contained in this document; and

(e)You may revoke this Agreement for a period of seven (7) days following your execution hereof and all rights and obligations of both parties under this Agreement shall not become effective or enforceable until the seven (7) day revocation period has expired. Please see Section 12 for more details.

6. Covenant Not to Sue: A “covenant not to sue” is a legal term that means you promise not to file a lawsuit in court. It is different from the release of claims in Sections 4(a) and 5 above. Besides waiving and releasing the claims covered by Sections 4(a) and 5, you further agree never to sue the Released Parties in any forum based on the claims, laws or theories covered by the release language in Sections 4(a) and 5. You represent and warrant that you have not filed any complaints, charges, or claims for relief against the Released Parties with any local, state or federal court or administrative agency, with the sole exception of

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your right to pursue a state unemployment claim. Notwithstanding this Covenant Not to Sue, you may bring a claim as permitted under Section 4(e)(i). Except as set forth in Section 4(e)(i) or as permitted pursuant to this Section 6, if you institute any other action that is subject to the release of claims set forth in Sections 4(a), 4(b) and/or 5, that claim shall be dismissed upon the presentation of this Agreement and you shall reimburse the Company for all legal fees and expenses incurred in defending such claim and obtaining its dismissal. Notwithstanding the foregoing, should you bring an action to challenge the validity of the release and waiver of ADEA claims based on the insufficiency of the disclosures included in Section 5, the Company acknowledges that it will not be entitled to recover costs and expenses (including attorneys’ fees) incurred in defense of the validity of the release and waiver of ADEA claims.

7. Company Property: By the Separation Date, except as required to perform services under the Consulting Agreement, you agree to return to the Company all Company property and materials, including, but not limited to, laptops, tablets, cds, dvds, hard drives, portable drives, intangible information stored on any such hardware and/or media, software programs and data compiled with the use of those programs, software passwords or codes, tangible copies of trade secrets and Confidential Information (as that term is defined in your NDA (see Section 9 below), charge/credit cards, building keys and passes, trial information, clinical information, lab notes, lab notebooks, memoranda, business or marketing plans, reports, projections, and any and all other information or property previously or currently held or used by you that is or was related to your employment with the Company (“Property”). If you discover any other Property, including any proprietary materials, in your possession after the Separation Date, you immediately will notify the Company and arrange for their promptreturn. Except as required to perform services under the Consulting Agreement, you also must delete and finally purge any duplicates of files or documents that may contain Company information from any non-Company computer or other device that remains in your possession after the Separation Date. Failure to return immediately any such materials will be considered a breach of this Agreement. Subject to the nondisclosure obligations set forth in the NDA (as defined below), nothing herein shall require you to return (i) any personal compensation, benefits, stock option or tax information specific to your employment with the Company, (ii) copies of any contract or agreement between you and the Company, or (iii) materials distributed to shareholders generally.

8. No Liability or Wrongdoing: You understand and agree that the release and accord and satisfaction set forth in Section 4(d) constitute a final compromise of the claims released thereby, and are not an admission by the Released Parties that any such claims exist and/or of liability by the Released Parties with respect to such claims. Nothing in this Agreement, nor any of the proceedings connected with it, is to be construed as, offered as, received as, or deemed to be evidence of an admission by the Released Parties of any liability or unlawful conduct whatsoever, and each of the Released Parties expressly deny any such liability or wrongdoing.

9. Future Conduct:

(a) Employee Nondisclosure, Noncompetition and Assignment of Intellectual Property Agreement: You confirm the existence and continued validity of your Employee Nondisclosure, Noncompetition and Assignment of Intellectual Property Agreement (the “NDA”). A copy of your NDA is enclosed herewith. You agree that your obligations under the NDA expressly survive the end of your employment, and a condition of the Company paying severance benefits to you is that you abide by the terms of the NDA in accordance with the NDA’s terms.

(b) Non-disparagement; Confidentiality of this Agreement: You agree not to take any action or make any statement, written or oral, which disparages or criticizes the Released Parties, their officers, directors, investors or employees, the Released Parties’ business practices, or which disrupts or impairs their normal

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operations, including actions that would (i) harm the Released Parties’ reputation with their current and prospective clients, business partners, or the public; or (ii) interfere with existing contracts or employment relationships with current and prospective clients, business partners or Released Parties’ employees. Further, you shall maintain confidentiality concerning this Agreement, including the substance, terms, existence and/or any discussions relating to it. Except as required by legal or regulatory process, you will not discuss the same with anyone except your immediate family, and (when such disclosure is necessary for them to render professional services) accountants and attorneys. Nothing herein shall prohibit or bar you from providing truthful testimony in any legal or regulatory proceeding or in communicating with any Government Agencies or representative or from making any truthful disclosure required, authorized or permitted under law or regulation; provided, however, that in providing such testimony or making such disclosures or communications, you will use your best efforts to ensure that this Section is complied with to the maximum extent reasonably possible. Unless required by law, the Company agrees that neither the Company nor, during their term of employment, its current Chief Executive Officer, Armon Sharei, PhD, Chief Business Officer, Micah Zajic, Chief People Officer, David First, Vice President and Head of Exploratory, Jon Gilbert, and General Counsel, Lawrence Knopf, Esq., shall make statements, remarks or comments to third parties, orally, in writing or via social media, directly or indirectly, that are, or could be reasonably interpreted to be, disparaging about you or indicate that your separation from the Company was involuntary.The Company will instruct members of Board of Directors of the Company not to make statements, remarks or comments to third parties, orally, in writing or via social media, directly or indirectly, that are, or could be reasonably interpreted to be, disparaging about you or indicate that your separation from the Company was involuntary.

(c) Advance Notice: Except as set forth in Section 4(e) or as otherwise prohibited by applicable law, above, you agree to give reasonable notice to the Company of any and all attempts by third parties to compel disclosure of any confidential information (as referred to in your NDA), the terms of this Agreement, or to require you to testify in any matter concerning the Company, this Agreement and/or the Released Parties. Please direct such notice in writing to the Company’s General Counsel at least ten business days before compliance with any subpoena or order; if the subpoena or order requires compliance within less than ten business days, however, you shall provide such written notice, or if impractical, shall provide telephonic notice, within five business days after receiving notice that an attempt will be or has been made to compel your testimony or your disclosure of the Company’s confidential information.

(d) Breach; Remedies: In the event that litigation becomes necessary to resolve any case or controversy arising pursuant to this Agreement, the NDA, the Option, or any other agreement referenced herein, the parties agree that the prevailing party shall be entitled to recover from the non-prevailing party its/his attorneys’ fees and costs incurred in enforcing its/his rights under such agreement, to the extent such recovery is not prohibited by law. If you materially breach this Agreement, the NDA, the Option or the Consulting Agreement, you agree, provided that you have failed to cure such breach within twenty-one (21) days of receipt of written notice from the Company describing such breach, that the Company shall be relieved of its obligations to make any further payments to you under Section 2 of this Agreement or under the Consulting Agreement and the Company shall be entitled to recover 95% of payments already made to you pursuant to Section 2. This Agreement in all other respects, including, but not limited to, the release provisions in Section 4(a), shall remain in full force and effect. The remedies in this Section shall be in addition to, and not as an alternative to, any other available remedies at law or in equity.

(e) Defend Trade Secrets Act Notice. You are hereby notified in accordance with the Defend Trade Secrets Act of 2016 that you will not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that is made in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney solely for the purpose of reporting or

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investigating a suspected violation of law, or that is made in a complaint or other document that is filed under seal in a lawsuit or other proceeding. If you file a lawsuit for retaliation against the Company for reporting a suspected violation of law, you may disclose the Company’s trade secrets to your attorney and use the trade secret information in the court proceeding if you file any document containing the trade secret under seal, and do not disclose the trade secret, except pursuant to court order.

(f)Prior Review of Separation Language. Prior to the Separation Date, the Company agrees to provide you a reasonable opportunity to comment, and will consider your comments in good faith, on the proposed language announcing your separation from the Company to be included or disseminated by the Company (i) in any filing pursuant to securities laws (including on Form 8-K), (ii) in any press release, (iii) in any social media post, (iv) on any website controlled by the Company, or (v) in other similar written or electronic published medium. Such disclosure shall standalone and shall not be commingled with other disclosures except as may be required by law or regulation.

10. Cooperation: You agree to cooperate fully with the Company’s employees and business partners in completely transitioning your work as the Company may reasonably designate. You agree to be available for reasonable periods of time (at mutually convenient times, considering your own commitments), either by telephone or, if you and the Company believe necessary, in person upon reasonable notice, to assist with matters relating to work performed by you on the Company’s behalf. You also agree to cooperate with the Company and its attorneys at reasonable times and places in the prosecution and/or defense of any legal action wherein the Company is a party. Such cooperation includes, but is not limited to, meeting with the Company’s attorneys at reasonable times and places to discuss your knowledge of pertinent facts, appearing as required at deposition, arbitration, trial or other proceeding to testify as to those facts, and testifying truthfully to the best of your abilities at any such proceeding. The Company shall reimburse you for any reasonable and approved out-of-pocket travel-related costs and expenses you incur in connection with such cooperation. The Company shall pay you a reasonable, mutually agreeable hourly rate for documented time you spend at the request of the Company providing cooperation or assistance pursuant to this Section 10, to the extent the cooperation or assistance is provided after the end of your service pursuant to the Consulting Agreement.

11. Representations, Governing Law, Miscellaneous:

(a) Entire Agreement; Amendment; Waiver; Construction of Agreement: This Agreement sets forth the complete and sole agreement between the parties and supersedes any and all other agreements or understandings, whether oral or written, express or implied, except for the NDA, the Consulting Agreement and the Equity Documents, which are expressly preserved herein and remain in full force and effect in accordance with their terms. This Agreement may not be changed or rescinded except upon the express written consent of both you and an authorized Company officer. Any waiver of any provision of this Agreement must be set forth in a written instrument signed by the party waiving compliance and shall not constitute a waiver of any other provision of this Agreement unless expressly so indicated otherwise. The language of all parts of this Agreement shall in all cases be construed as a whole according to its fair meaning and not strictly for or against either party.

(b) Governing Law; Consent to Jurisdiction: This Agreement shall be deemed to be made and entered into in the Commonwealth of Massachusetts. This Agreement and any claims arising out of this Agreement (or any other claims arising out of the relationship between the parties) shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts and shall in all respects be interpreted, enforced and governed under the internal and domestic laws, without giving effect to the principles of

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conflicts of laws of such Commonwealth. Any claims or legal actions by one party against the other shall be commenced and maintained in any state or federal court located in such Commonwealth, and the parties hereby submit to the jurisdiction and venue of any such court. EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.

(c) Severability: If any provision of this Agreement, or part thereof, is held invalid, void or voidable as against public policy or otherwise, the invalidity shall not affect other provisions, or parts thereof, which may be given effect without the invalid provision or part. To this extent, the provisions, and parts thereof, of this Agreement are declared to be severable.

(d) Assignment: You shall not assign this Agreement; the Company may assign this Agreement. The benefits and obligations of this Agreement shall inure to the successors and assigns of the Company and the Released Parties and to your successors.

(e) Acknowledgment of Company’s Compliance with Applicable Law: You represent that:

(i) you have not been subject to any retaliation or any other form of adverse action by the Released Parties for any action taken by you as an employee or resulting from your exercise of, or attempt to exercise, any statutory rights recognized under federal, state or local law;

(ii) you have been paid all unpaid wages and accrued unused vacation that are due and payable as of the date of your execution of this Agreement;

(iii) the Released Parties have satisfied in full all obligations they ever had regarding leaves of absence and other time off of any kind (including, but not limited to, short-term disability leave, family medical leave, military leave, vacations, meal and rest periods, sick and personal days, and personal leave), and you have not suffered any adverse employment action as a result of seeking or taking any such leave of absence or time off; and

(iv) you have no known workplace injuries or occupational diseases, have not sustained any disabling injury and/or occupational disease that have resulted in a loss of wage-earning capacity during your employment, and have no personal injury and/or occupational disease that has been contributed to, or aggravated or accelerated in a significant manner by, your employment or separation from employment.

(f) Counterparts/Electronic Signature: This Agreement may be executed in any number of counterparts, each of which will be deemed an original, but all of which will be deemed one and the same instrument. This Agreement may be executed by facsimile or electronic signature, and any such signature by any party shall be deemed to be an original signature and shall be binding on such party to the same extent as if such facsimile or electronic signature were an original signature.

12. Review Period; Expiration of this Offer: As set forth in Section 5, you will have the opportunity to review and consider this Agreement for twenty-one (21) days before signing it.In addition, you have the right to revoke your execution of this Agreement at any time during the seven (7) days immediately following the date on which you sign it. For such a revocation to be effective, it must be delivered by email to David First via email at or before the expiration of the seven (7) day revocation period. This Agreement shall become effective on the first day following the expiration of the seven (7) day revocation period (the “Effective Date”). Because this Agreement includes a waiver and release of your rights, the Company advises you to consult with an attorney prior to executing it.

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If you wish to accept this Agreement, please sign and date the Agreement below as well as the Consulting Agreement and return them to David First via email on or before 5:00 p.m. on September 16, 2022, which is at least 21 days after the date you received a copy of this Agreement. If you do not return a signed Agreement prior to the expiration of the review period, then this offer of severance shall expire.

We thank you for your service and wish you well.

Very truly yours,

SQZ Biotechnologies Company,

_/s/ David First_____________________

By: David First

Title: Chief People Officer

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PLEASE REVIEW CAREFULLY

THIS AGREEMENT HAS A RELEASE OF CERTAIN LEGAL RIGHTS YOU MAY HAVE. YOU SHOULD CONSULT WITH AN ATTORNEY REGARDING THE RELEASE AND OTHER ASPECTS OF THIS AGREEMENT BEFORE SIGNING IT.

YOU UNDERSTAND THAT BY SIGNING THIS AGREEMENT, YOU ARE EXPRESSLY WAIVING ANY AND ALL RIGHTS TO A TRIAL OR HEARING BEFORE A JURY FOR ANY AND ALL DISPUTES AND CLAIMS RELATING TO THIS AGREEMENT, THE TRANSACTIONS CONTEMPLATED THEREBY, AND/OR THE EMPLOYMENT RELATIONSHIP.

YOUR EMPLOYMENT BY THE COMPANY WILL TERMINATE ON OCTOBER 31, 2022. SUCH TERMINATION WILL NOT BE AFFECTED BY YOUR ACCEPTANCE OR FAILURE TO ACCEPT THIS AGREEMENT. IF YOU DO NOT ACCEPT IT, YOU WILL NOT RECEIVE THE PAYMENTS IN SECTION 2.

YOU REPRESENT THAT YOU HAVE READ THE FOREGOING AGREEMENT, FULLY UNDERSTAND ITS TERMS AND CONDITIONS, AND VOLUNTARILY ARE EXECUTING IT.

IN ENTERING INTO THIS AGREEMENT, YOU DO NOT RELY ON ANY REPRESENTATION, PROMISE OR INDUCEMENT MADE BY THE RELEASED PARTIES WITH THE EXCEPTION OF THE CONSIDERATION IN THIS DOCUMENT.

ACCEPTED:

_/s/ Howard Bernstein ___________________ Date: September 2, 2022

Howard Bernstein

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EXHIBIT A

Transition Consulting Agreement

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Exhibit B

CERTIFICATE UPDATING RELEASE OF CLAIMS

[TO BE SIGNED NO EARLIER THAN October 31, 2022]

I, Howard Bernstein, hereby acknowledge and certify that I entered into a Severance Agreement and General Release (the “Agreement”) with SQZ Biotechnologies Company (the “Company”). Pursuant to that Agreement, I am required to execute this certificate, which updates the release of claims in Section 4 of the Agreement (this “Certificate”) in order to receive the severance benefits in Section 2 of the Agreement. I, therefore, agree as follows:

1.A blank copy of this Certificate was attached to the Agreement as Exhibit B. I hereby certify and acknowledge that I received the Agreement and this Certificate at least 21 days before I was required to sign them. The Company has advised me to consult an attorney prior to signing this Certificate.

2.In consideration of the severance payments and benefits described in Section 2 of the Agreement, for which I become eligible only if I sign this Certificate, I hereby extend the release of claims in Section 4 of the Agreement to any and all claims that arose after the date I signed the Agreement through the date I signed this Certificate, subject to all other exclusions and terms set forth in the Agreement.

3.I have carefully read and fully understand all of the provisions of this Certificate, I knowingly and voluntarily agree to all of the terms set forth in this Certificate, and I acknowledge that in entering into this Certificate, I am not relying on any representation, promise or inducement made by the Company or its representatives with the exception of those promises contained in the Certificate and the Agreement; and

4.I agree that this Certificate is part of the Agreement.

______________________________

Howard Bernstein

Date: _________________________

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EX-10.2

Exhibit 10.2

TRANSITION CONSULTING AGREEMENT

This Consulting Agreement (this "Agreement") dated as of November 1, 2022 (the “Effective Date”), is made by and between SQZ Biotechnologies Company, a Delaware corporation (the "Company"), and Howard Bernstein (the "Consultant").

The Company desires to engage the Consultant to perform consulting services on behalf of the Company and the Consultant desires to perform such services on the terms and conditions hereinafter set forth.

In consideration of the agreements set forth in this Agreement and intending to be legally bound by this Agreement the parties agree as follows:

1. Consulting Services. The Company hereby retains the Consultant and the Consultant hereby agrees to perform the consulting services described in Schedule A to this Agreement (the “Consulting Services”).

2. Compensation. The Company shall pay the Consultant a consulting fee as provided in Schedule A. The Company will reimburse the Consultant for such reasonable business expenses as are incurred by the Consultant in the performance of Consulting Services for the Company and pre-approved in writing by the Company.

3. Independent Contractor. In furnishing the Consulting Services, the Consultant understands that the Consultant will at all times be acting as an independent contractor of the Company and, as such, will not be an employee of the Company and will not by reason of this Agreement or by reason of the Consulting Services to the Company be entitled to participate in or to receive any benefit or right under any of the Company's employee benefit or welfare plans. The Consultant also will be responsible for paying all withholding and other taxes required by law to be paid as and when the same become due and payable. Consultant shall not enter into any agreements or incur any obligations on behalf of the Company.

4. Term. This Agreement shall remain in effect through the one year anniversary of the Effective Date, unless amended by mutual written agreement of the parties, and further provided that both the Consultant and the Company may terminate this Agreement at any time due to the other party’s material breach of this Agreement which is not cured within thirty (30) days’ written notice to the non-breaching party describing such breach.

5. Confidential Information.

(a) While providing the Consulting Services to the Company and thereafter, the Consultant shall not, directly or indirectly, use any Confidential Information (as defined below) other than pursuant to Consultant’s provision of the Consulting Services by and for the benefit of the Company, or disclose to anyone outside of the Company any such Confidential Information. The term "Confidential Information" as used throughout this Agreement shall mean all trade secrets, proprietary information and other data or information (and any tangible evidence, record or representation thereof), written or oral, whether prepared, conceived or developed by a

DOCPROPERTY "CUS_DocIDString" B4115942.v1

consultant or employee of the Company (including the Consultant) or received by the Company from an outside source, which is in the possession of the Company (whether or not the property of the Company) and which is maintained in secrecy or confidence by the Company. Notwithstanding the foregoing, the term Confidential Information shall not apply to information which (i) the Company has voluntarily disclosed to the public without restriction or which has otherwise lawfully entered the public domain, (ii) becomes known to the Consultant through disclosure by sources other than the Company without such sources violating any confidentiality obligations to the Company or (iii) is independently developed by the Consultant without reference to or reliance upon the Company’s Confidential Information.

(b) The Consultant acknowledges that the Company from time to time has in its possession information (including product and development plans and specifications) which represent information which is claimed by others to be proprietary and which the Company has agreed to keep confidential. The Consultant agrees that all such information shall be Confidential Information for purposes of this Agreement.

(c) The Consultant agrees that all originals and all copies of materials containing, representing, evidencing, recording, or constituting any Confidential Information, however and whenever produced (whether by the Consultant or others), shall be the sole property of the Company.

6. Inventions.

(a) Certain inventions made by others. The Consultant will disclose to the Company technology and product opportunities which come to the attention of the Consultant that directly relate to the business of the Company (the “Business”), and any invention, improvement, discovery, process, formula or method or other intellectual property directly relating to the Business, whether or not patentable or copyrightable, and whether or not discovered or developed by Consultant.

(b) Inventions made by the Consultant. The Consultant agrees that all Confidential Information and all other discoveries, inventions, ideas, concepts, trademarks, service marks, logos, processes, products, formulas, computer programs or software, source codes, object codes, algorithms, machines, apparatuses, items of manufacture or composition of matter, or any new uses therefor or improvements thereon, or any new designs or modifications or configurations of any kind, or works of authorship of any kind, including, without limitation, compilations and derivative works, whether or not patentable or copyrightable, conceived, developed, reduced to practice or otherwise made by the Consultant during the term of this Agreement, either alone or with others, and directly related to or arising out of: (i) the Business when made on or after the Effective Date; (ii) the Consulting Services; or (iii) Confidential Information of the Company, whether or not conceived, developed, reduced to practice or made on the Company’s premises (collectively “Inventions”), and any and all services and products which embody, emulate or employ any such Invention or Confidential Information shall be the sole property of the Company and all copyrights, patents, patent rights, trademarks and reproduction rights to, and other proprietary rights in, each such Invention or Confidential Information, whether or not patentable or copyrightable, shall belong exclusively to the Company without further compensation of any kind to Consultant. The Consultant agrees that all such Inventions shall constitute works made for

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hire under the copyright laws of the United States and hereby assigns and, to the extent any such assignment cannot be made at the present time, agrees to assign to the Company, without any additional consideration from the Company, any and all copyrights, patents and other proprietary rights Consultant may have in any such Invention, together with the right to file and/or own wholly without restrictions applications for United States and foreign patents, trademark registration and copyright registration and any patent, or trademark or copyright registration issuing thereon.

7. Consultant’s Obligation to Keep Records. Consultant shall make and maintain adequate and current written records of all Inventions, and shall disclose all Inventions promptly, fully and in writing to the Company immediately upon development of the same and at any time upon request.

8. Consultant’s Obligation to Cooperate. The Consultant will, at any time during or after the term of this Agreement, upon request of the Company, execute all documents and perform all lawful acts which the Company reasonably considers necessary or advisable to secure its rights hereunder and to carry out the intent of this Agreement. Without limiting the generality of the foregoing, the Consultant will: (i) assist the Company in any reasonable manner to obtain for the Company’s benefit patents or copyrights in any and all countries with respect to all Inventions assigned pursuant to Section 6, and the Consultant will execute, when requested, patent and other applications and assignments thereof to the Company and any other lawful documents reasonably deemed necessary by the Company to carry out the purposes of this Agreement; and (ii) assist the Company at reasonable times and places in every reasonable way to enforce any patents and copyrights obtained, including testifying in any suit or proceeding involving any of said patents or copyrights or executing any documents reasonably deemed necessary by the Company. In the event that the Company makes a request for assistance pursuant to this Section and it would require Consultant more than one hour to reasonably perform such assistance, then the Company shall compensate Consultant for Consultant’s time at the rate per hour most recently in effect under this Agreement. The Company shall also reimburse the Consultant for reasonable out-of-pocket expenses incurred at the request of the Company pursuant to this Section. In regards to out-of-pocket expenditures for travel, based on the travel policy of the Client, good-faith efforts shall be made to avoid business or first-class travel whenever possible.

9. Return of Property. Upon termination of the Consultant’s engagementwith the Company, or at any other time upon request of the Company, the Consultant shall return promptly any and all Confidential Information belonging to the Company or its customers which the Consultant may then possess or have under Consultant’s control. The Consultant further agrees that upon termination of Consultant’s engagement Consultant shall not take with Consultant any documents or data in any form or of any description containing or pertaining to Confidential Information or any Inventions. However, Consultant's obligations of confidentiality and restrictions on the use of Confidential Information disclosed by the Company, shall survive the termination of this Agreement (a) indefinitely with respect to any software source code or any information treated by the Company as a trade secret; and (b) otherwise, for a period of five (5) years from the date of disclosure.

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10. Limits of Liability; Indemnification.

(a) Neither party shall have any liability under any provision of this Agreement for any incidental, consequential, punitive, multiple or other special damages. Except with respect to the Company’s liability set forth in Section 10(b), in no event shall a party’s aggregate liability to Company under this Agreement exceed the total of fifty percent (50%) all fees actually paid by Company to Consultant for the Services.

(b) The Company will defend, indemnify and hold the Consultant and (if/as applicable) its directors, managers, members, owners, officers, employees, contractors, agents, successors and assigns (each, a “Consultant Indemnified Party/ies”) harmless from and against any and all claims, liabilities, judgments, damages, suits, costs and expenses, including court costs and reasonable attorneys’ fees of any nature whatsoever (“Losses”), with respect to, arising out of, or in connection with (a) any breach of any provision of this Agreement or any agreement, representation or warranty made by the Company herein; (b) any act or omission of the Company; and/or (c) the Company’s failure to comply with applicable laws, policies and regulations.

11. Miscellaneous.

(a) Entire Agreement. This Agreement and the documents referred to herein constitute the entire agreement among the parties with respect to the subject matter hereof and supersede all other prior agreements and understandings, both written and oral, between the parties with respect to such subject matter.

(b) Assignment. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns. This Agreement is not intended to confer upon any person other than the parties hereto any rights or remedies hereunder, except as otherwise expressly provided herein and shall not be assignable by operation of law or otherwise. Notwithstanding the foregoing, the parties agree that Consultant may, upon notice to the Company, assign its rights and obligations under this Agreement to a corporation or limited liability company of which the Consultant is the majority owner, provided that all Services shall be rendered (on behalf of said entity) by the Consultant.

(c) Amendments and Supplements. This Agreement may not be altered, changed or amended, except by an instrument in writing signed by the parties hereto.

(d) No Waiver. The terms and conditions of this Agreement may be waived only by a written instrument signed by the party waiving compliance. The failure of any party hereto to enforce at any time any of the provisions of this Agreement shall in no way be construed to be a waiver of any such provision, nor in any way to affect the validity of this Agreement or any part hereof or the right of such party thereafter to enforce each and every such provision. No waiver of any breach of or non-compliance with this Agreement shall be held to be a waiver of any other or subsequent breach or non-compliance.

(e) Governing law. This Agreement shall be governed by, and construed and enforced in accordance with, the substantive laws of The Commonwealth of Massachusetts, without regard to its principles of conflicts of laws.

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(f) Survival; Validity. Notwithstanding the termination of the Consultant’s relationship with the Company (whether pursuant to Section 4 or otherwise), the Consultant’s covenants and obligations set forth in Sections 6, 7, 8, 9 and 10 shall remain in effect and be fully enforceable in accordance with the provisions thereof.

(g) Counterparts. This Agreement may be executed in one or more counterparts, all of which together shall constitute one and the same Agreement.

(h) Force Majeure. In the event either party shall be delayed or hindered in or prevented from the performance of any act required, hereunder by reason of strike, lockouts, labor troubles, inability to procure materials or services, failure of power, judicial orders or decrees, riots, insurrection, war, Acts of God, inclement weather, disease, epidemic, pandemic, quarantine, acts of government or other reason or cause beyond that party’s reasonable control, then performance of such act (except for the payment of money owed) shall be excused for the period of such delay.

The Company and the Consultant have caused this Agreement to be executed as of the date first written above.

SQZ BIOTECHNOLOGIES COMPANY

By:_/s/ Armon Sharei ________________
Name: Armon Sharei
Title: Chief Executive Officer

Date: September 2, 2022

CONSULTANT

/s/ Howard Bernstein Name: Howard Bernstein

Date: September 2, 2022

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Schedule A

Description of Services to be Rendered:

Consultant shall provide scientific, technical and manufacturing advisory services, including serving as an advisor and mentor for members of the R&D, Quality and Product Development teams, for the period commencing as of the Effective Date and terminating as of the one year anniversary of the Effective Date, unless amended by mutual written agreement of the parties, as reasonably requested by the Chief Executive Officer of the Company or the Chair of the R&D Committee of the Board of Directors. Services shall be rendered at times and dates mutually convenient to the parties as follows: (i) ten (10) hours per week from the Effective Date through December 31, 2022 (proportionately reduced in weeks in which the Company is closed for holidays or other reasons), and (ii) as mutually agreed thereafter during the term. Unless otherwise agreed, Services shall be compensated at a rate of Three Hundred Dollars ($300) per hour.

Compensation:

As provided herein and in the Separation Agreement between Howard Bernstein and the Company dated as of September 2, 2022.

Reimbursement Terms:

Consultant shall invoice the Company on a monthly basis for time and reasonable expenses incurred in performing the Services. The Company shall remit payment of all undisputed charges to Consultant within thirty (30) days of the Company’s receipt of each invoice.

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EX-31.1

Exhibit 31.1

CERTIFICATION

I, Armon Sharei, Ph.D., certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of SQZ Biotechnologies Company;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 9, 2022	By:	/s/ Armon Sharei, Ph.D.
		Armon Sharei, Ph.D.
		Chief Executive Officer (principal executive officer)

EX-31.2

Exhibit 31.2

CERTIFICATION

I, Micah Zajic, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of SQZ Biotechnologies Company;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 9, 2022	By:	/s/ Micah Zajic
		Micah Zajic
		Chief Financial Officer (principal financial officer)

EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of SQZ Biotechnologies Company (the “Company”) for the period ended September 30, 2022, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: November 9, 2022	By:	/s/ Armon Sharei, Ph.D.
		Armon Sharei, Ph.D.
		Chief Executive Officer (principal executive officer)

EX-32.2

Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of SQZ Biotechnologies Company (the “Company”) for the period ended September 30, 2022, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: November 9, 2022	By:	/s/ Micah Zajic
		Micah Zajic
		Chief Financial Officer (principal financial officer)

XML

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2022	Nov. 03, 2022
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2022
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Entity Registrant Name	SQZ BIOTECHNOLOGIES COMPANY
Entity Central Index Key	0001604477
Entity Incorporation, State or Country Code	DE
Current Fiscal Year End Date	--12-31
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	SQZ
Security Exchange Name	NYSE
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Shell Company	false
Entity Ex Transition Period	false
Entity Common Stock, Shares Outstanding		29,450,616
Entity Address, State or Province	MA
Entity File Number	001-39662
Entity Tax Identification Number	46-2431115
Entity Address, Address Line One	200 Arsenal Yards Blvd
Entity Address, Address Line Two	Suite 210
Entity Address, City or Town	Watertown
Entity Address, Postal Zip Code	02472
City Area Code	617
Local Phone Number	758-8672

XML

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 84,239	$ 143,513
Accounts receivable		3,000
Prepaid expenses and other current assets	3,098	4,122
Total current assets	87,337	150,635
Property and equipment, net	2,521	3,046
Restricted cash	2,305	2,305
Deferred offering costs	306	323
Operating lease right-of-use assets	62,385	69,843
Total assets	154,854	226,152
Current liabilities:
Accounts payable	3,311	3,971
Accrued expenses	7,823	6,810
Current portion of deferred revenue	3,500	12,507
Current portion of operating lease liabilities	10,627	9,936
Total current liabilities	25,261	33,224
Deferred revenue, net of current portion	9,196	9,196
Operating lease liabilities, net of current portion	51,823	59,756
Total liabilities	86,280	102,176
Commitments and contingencies (Note 8)
Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2022 and December 31, 2021; No shares issued or outstanding.
Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2022 and December 31, 2021; 29,350,158 and 28,133,368 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively.	29	28
Additional paid-in capital	329,972	319,458
Accumulated deficit	(261,427)	(195,510)
Total stockholders’ equity	68,574	123,976
Total liabilities and stockholders’ equity	$ 154,854	$ 226,152

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Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	200,000,000	200,000,000
Common stock, shares issued	29,350,158	28,133,368
Common stock, shares outstanding	29,350,158	28,133,368

XML

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Revenue Not from Contract with Customer	$ 322		$ 524
Revenues, Total	$ 3,452	$ 4,755	$ 9,535	$ 14,748
Revenue, Product and Service [Extensible Enumeration]	Collaboration [Member]	Collaboration [Member]	Collaboration [Member]	Collaboration [Member]
Operating expenses:
Research and development	$ 19,631	$ 20,520	$ 55,401	$ 52,942
General and administrative	6,919	6,691	20,789	18,744
Total operating expenses	26,550	27,211	76,190	71,686
Loss from operations	(23,098)	(22,456)	(66,655)	(56,938)
Other income (expense):
Interest income	436	8	608	28
Other income (expense), net	19	(2)	130	(9)
Total other income, net	455	6	738	19
Net loss and comprehensive loss	$ (22,643)	$ (22,450)	$ (65,917)	$ (56,919)
Net loss per share, basic	$ (0.77)	$ (0.80)	$ (2.30)	$ (2.08)
Net loss per share, diluted	$ (0.77)	$ (0.80)	$ (2.30)	$ (2.08)
Weighted-average common shares outstanding, basic	29,284,151	28,050,130	28,603,020	27,421,839
Weighted-average common shares outstanding, diluted	29,284,151	28,050,130	28,603,020	27,421,839
Collaboration [Member]
Revenue	$ 3,130	$ 4,755	$ 9,011	$ 14,748

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Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Total	Public Offering [Member]	At-the-market Offering [Member]	Common Stock [Member]	Common Stock [Member] Public Offering [Member]	Common Stock [Member] At-the-market Offering [Member]	Additional Paid-in Capital [Member]	Additional Paid-in Capital [Member] Public Offering [Member]	Additional Paid-in Capital [Member] At-the-market Offering [Member]	Accumulated Deficit [Member]
Beginning balance at Dec. 31, 2020	$ 127,199			$ 25			$ 253,943			$ (126,769)
Beginning balance (Shares) at Dec. 31, 2020				24,786,324
Issuance of common stock		$ 55,602			$ 3			$ 55,599
Issuance of common stock (Shares)					3,000,000
Issuance of common stock upon exercise of stock options	1,131						1,131
Issuance of common stock upon exercise of stock options (Shares)				278,445
Stock-based compensation expense	6,193						6,193
Net loss	(56,919)									(56,919)
Ending balance at Sep. 30, 2021	133,206			$ 28			316,866			(183,688)
Ending balance (Shares) at Sep. 30, 2021				28,064,769
Beginning balance at Jun. 30, 2021	152,704			$ 28			313,914			(161,238)
Beginning balance (Shares) at Jun. 30, 2021				28,031,404
Issuance of common stock upon exercise of stock options	171						171
Issuance of common stock upon exercise of stock options (Shares)				33,365
Stock-based compensation expense	2,781						2,781
Net loss	(22,450)									(22,450)
Ending balance at Sep. 30, 2021	133,206			$ 28			316,866			(183,688)
Ending balance (Shares) at Sep. 30, 2021				28,064,769
Beginning balance at Dec. 31, 2021	123,976			$ 28			319,458			(195,510)
Beginning balance (Shares) at Dec. 31, 2021				28,133,368
Issuance of common stock under employee stock purchase plan	$ 111						111
Issuance of common stock under employee stock purchase plan (Shares)				41,265
Issuance of common stock			$ 3,745			$ 1			$ 3,744
Issuance of common stock (Shares)	1,160,768					1,160,768
Issuance of common stock upon exercise of stock options	$ 29						29
Issuance of common stock upon exercise of stock options (Shares)	14,757			14,757
Stock-based compensation expense	$ 6,630						6,630
Net loss	(65,917)									(65,917)
Ending balance at Sep. 30, 2022	68,574			$ 29			329,972			(261,427)
Ending balance (Shares) at Sep. 30, 2022				29,350,158
Beginning balance at Jun. 30, 2022	88,188			$ 29			326,943			(238,784)
Beginning balance (Shares) at Jun. 30, 2022				29,148,053
Issuance of common stock	653								$ 653
Issuance of common stock (Shares)						202,105
Stock-based compensation expense	2,376						2,376
Net loss	(22,643)									(22,643)
Ending balance at Sep. 30, 2022	$ 68,574			$ 29			$ 329,972			$ (261,427)
Ending balance (Shares) at Sep. 30, 2022				29,350,158

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Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2022	Sep. 30, 2021
Payment of issuance costs			$ 1,904
Public Offering [Member]
Payment of issuance costs			$ 798
At-the-market Offering [Member]
Payment of issuance costs	$ 3	$ 195

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Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash flows from operating activities:
Net loss	$ (65,917)	$ (56,919)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation and amortization expense	833	932
Amortization of operating lease right-of-use assets	7,458	7,384
Stock-based compensation expense	6,630	6,193
Loss on disposal of equipment	43	7
Changes in operating assets and liabilities:
Accounts receivable	3,000	1,892
Prepaid expenses and other current assets	1,024	2,669
Accounts payable	(624)	(507)
Accrued expenses	1,013	(1,402)
Deferred revenue	(9,007)	(14,523)
Operating lease liabilities	(7,242)	(6,843)
Net cash used in operating activities	(62,789)	(61,117)
Cash flows from investing activities:
Purchases of property and equipment	(421)	(613)
Proceeds from disposals of property and equipment	34
Cash flows from investing activities	(387)	(613)
Cash flows from financing activities:
Proceeds from issuance of common stock		56,400
Payment of issuance costs		(1,904)
Proceeds from issuance of common stock under at-the market offering	3,762
Proceeds from issuance of common stock under employee stock purchase plan	111
Proceeds from exercise of stock options	29	1,131
Net cash provided by financing activities	3,902	55,627
Net (decrease) increase in cash, cash equivalents and restricted cash	(59,274)	(6,103)
Cash, cash equivalents and restricted cash at beginning of period	145,818	172,662
Cash, cash equivalents and restricted cash at end of period	$ 86,544	166,559
Supplemental disclosure of non-cash investing and financing activities:
Lease assets obtained in exchange for operating lease liabilities		$ 31,306

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Nature of the Business and Basis of Presentation

9 Months Ended

Sep. 30, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Nature of the Business and Basis of Presentation

1. Nature of the Business and Basis of Presentation

SQZ Biotechnologies Company (the “Company”) is a clinical-stage biotechnology company developing cell therapies for patients with cancer, autoimmune and infectious diseases and other serious conditions. The Company uses its proprietary Cell Squeeze technology to physically squeeze cells through a microfluidic chip, temporarily opening the cell membrane and enabling biologic material of interest, or cargo, to diffuse into the cell. The Company is using Cell Squeeze technology to create multiple cell therapy platforms focused on directing specific immune responses. The Company was incorporated in March 2013 under the laws of the State of Delaware.

The Company is subject to a number of risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, the ability to obtain additional financing, protection of proprietary technology, dependence on key personnel, the ability to attract and retain qualified employees, compliance with government regulations, the impact of the COVID-19 pandemic, and the clinical and commercial success of its product candidates. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

Since inception, the Company has funded its operations primarily with payments received in connection with collaboration agreements, proceeds from equity and debt financing, and most recently, with proceeds from its 2020 initial public offering (“IPO”) and its 2021 follow-on offering. On November 10, 2021, the Company entered into an Open Market Sales Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) to issue and sell up to $75,000,000 in shares of the Company’s common stock from time to time during the term of the Sales Agreement through an “at-the-market” equity offering program under which Jefferies acts as the Company’s sales agent (the “ATM Facility”). During the nine months ended September 30, 2022, the Company sold 1,160,768 shares of common stock under the ATM Facility for net proceeds of approximately $3.7 million.

The Company has incurred recurring losses since inception, including net losses of $65.9 million for the nine months ended September 30, 2022. As of September 30, 2022, the Company had an accumulated deficit of $261.4 million. The Company expects to continue to generate operating losses for the foreseeable future. The Company’s current financial resources and currently forecasted operating plan would allow the Company to operate into the fourth quarter of 2023, but not for more than one year after the date that these condensed consolidated financial statements are issued. The Company is developing plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or debt financings, and/or potentially new collaborations, business transactions and reducing cash expenditures. If the Company is not able to secure adequate additional funding, the Company plans to make significant reductions in spending. In that event, the Company may have to delay, scale back, or eliminate some or all of the Company’s research and development programs and technology platform activities which could adversely affect its business prospects, or the Company may be unable to continue operations.

Management has assessed the Company’s ability to continue as a going concern in accordance with the requirements of ASC 205-40, taking into consideration its recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations. As of November 9, 2022, the issuance date of these interim condensed consolidated financial statements for the three and nine month periods ended September 30, 2022, the Company has concluded that there is substantial doubt about its ability to continue as a going concern for a period of one year from the date that these condensed consolidated financial statements are issued. The Company will require additional funding through private or public equity financings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into collaborations or other arrangements. The terms of any financing may adversely affect the holdings or the rights of the Company's stockholders. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. If the Company is unable to obtain funding, the Company will 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, or at all.

The accompanying condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. Accordingly, the consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.

Impact of the COVID-19 Pandemic

In December 2019, a novel strain of coronavirus, which causes the disease known as COVID-19, was initially reported and since then, COVID-19 has spread globally. In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic and the U.S. government-imposed travel restrictions on travel between the United States, Europe and certain other countries. The outbreak and government measures taken in response have had a significant impact, both direct and indirect, on hospitals, businesses and commerce, as worker shortages have occurred, supply chains have been disrupted, prices have increased, and the use of facilities and production have been suspended. The future progression of the pandemic and its effects on the Company’s business and operations are uncertain.

The COVID-19 pandemic has impacted and may continue to impact personnel at third-party manufacturing facilities or the availability or cost of materials, which would disrupt the Company’s supply chain. It also has affected and may continue to affect the Company’s ability to enroll patients in and timely complete its ongoing clinical trials of SQZ-PBMC-HPV, SQZ-AAC-HPV and SQZ-eAPC-HPV and delay the initiation of future clinical trials, disrupt regulatory activities or have other adverse effects on its business and operations.

The Company is monitoring the potential impact of the COVID-19 pandemic on its business and financial statements. To date, the Company has not incurred impairment losses in the carrying values of its assets as a result of the pandemic and it is not aware of any specific related event or circumstance that would require it to revise its estimates reflected in these interim condensed consolidated financial statements. The extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations, financial condition and liquidity, including planned and future clinical trials and research and development costs, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19, the actions taken to contain or treat it, and the duration and intensity of the related effects.

Basis of Presentation

The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, SQZ Biotechnologies Security Corporation, SQZ Biotech HK Limited and SQZ Biotech (Shanghai) Co., Ltd. All intercompany accounts and transactions have been eliminated in consolidation.

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Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Unaudited Interim Financial Information

The accompanying condensed consolidated financial statements as of September 30, 2022 and for the three and nine months ended September 30, 2022 and 2021 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. The accompanying condensed consolidated balance sheet as of December 31, 2021 was derived from audited financial statements but does not include all disclosures required by GAAP. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the SEC on March 16, 2022. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial position as of September 30, 2022, the consolidated results of operations for the three and nine months ended September 30, 2022 and 2021, and the consolidated cash flows for the nine months ended September 30, 2022 and 2021 have been made. The Company’s consolidated results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results of operations that may be expected for the full year or any other subsequent interim period.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, revenue recognition, the accrual of research and development expenses, and the valuation of stock-based awards. 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. On an ongoing basis, management evaluates its estimates, judgments and methodologies as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions.

Segment Information

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is developing methods of engineering cell function and therapies for the treatment of patients across a range of indications. The Company has determined that its chief operating decision maker is its Chief Executive Officer. The Company’s chief operating decision maker reviews the Company’s financial information on a consolidated basis for purposes of allocating resources and assessing financial performance.

Revenue Recognition for Government Grants

The Company generates revenue from government contracts that reimburse the Company for certain allowable costs for funded projects. For contracts with government agencies where the funding arrangement is considered central to the Company’s ongoing operations, the Company classifies the recognized funding received as revenue. Revenue from government grants is recognized as the qualifying expenses related to the contracts are incurred, provided that there is reasonable assurance of recoverability. The Company submits a budget, which outlines the expected project costs, to the funding government agency on a periodic basis. If the government agency approves the project proposed by the Company, the government agency generally funds the project upon receipt of the support for the costs incurred. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded as unbilled receivables, a component of prepaid expenses and other current assets, in the consolidated balance sheet. The related costs incurred by the Company are included in research and development expense in the Company’s consolidated statements of operations and comprehensive loss. In certain cases, the Company may obtain grants from an economic development agency that are not central to the Company's ongoing business. The income from these grants is recognized within Other income (expense), net in the consolidated statement of operations and comprehensive loss when there is reasonable assurance of recoverability.

Recently Issued Accounting Pronouncements

The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company will adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and will do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company. The Company may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for nonpublic companies.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes will result in the earlier recognition of credit losses, if any. In May 2019, the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”), which provides additional implementation guidance on the previously issued ASU 2016-13. For the Company, both ASU 2016-13 and ASU 2019-05 are effective for fiscal years beginning after December 15, 2022. The Company is currently evaluating the impact that the adoption of ASU 2016-13 will have on its consolidated financial statements, however the Company does not expect that the standard will have a material impact on its consolidated financial statements.

In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes (Topic 740) (“ASU 2019-12”), which simplifies the accounting for income taxes by eliminating certain exceptions, including the approach for intraperiod tax allocation, the accounting for income taxes in an interim period, hybrid taxes and the recognition of deferred tax liabilities for outside basis differences. It also clarifies and simplifies other aspects of the accounting for income taxes. The Company adopted this standard as of January 1, 2022 and the standard did not have a material impact on its consolidated financial statements.

In November 2021, the FASB issued ASU 2021-10, Disclosures by Business Entities about Government Assistance, which requires business entities to provide certain disclosures when they have 1) received government assistance and 2) use a grant or contribution accounting model by analogy to other accounting guidance. The Company adopted this standard as of January 1, 2022 and the standard did not have a material impact on its consolidated financial statements.

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Fair Value Measurements

9 Months Ended

Sep. 30, 2022

Fair Value Disclosures [Abstract]

Fair Value Measurements

3. Fair Value Measurements

The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands):

	FAIR VALUE MEASUREMENTS AT SEPTEMBER 30, 2022 USING:
	LEVEL 1		LEVEL 2		LEVEL 3		TOTAL
Assets:
Cash equivalents:
Money market funds	$	83,107	$	—	$	—	$	83,107
	$	83,107	$	—	$	—	$	83,107

	FAIR VALUE MEASUREMENTS AT DECEMBER 31, 2021 USING:
	LEVEL 1		LEVEL 2		LEVEL 3		TOTAL
Assets:
Cash equivalents:
Money market funds	$	142,547	$	—	$	—	$	142,547
	$	142,547	$	—	$	—	$	142,547

Money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. There were no changes to the valuation methods during the nine months ended September 30, 2022.The Company evaluates transfers between levels at the end of each reporting period. There were no transfers between levels during the nine months ended September 30, 2022.

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Property and Equipment, Net

9 Months Ended

Sep. 30, 2022

Property, Plant and Equipment [Abstract]

Property and Equipment, Net

4. Property and Equipment, Net

Property and equipment, net consisted of the following (in thousands):

	SEPTEMBER 30,			DECEMBER 31,
	2022			2021
Machinery and equipment	$	6,728		$	6,659
Leasehold improvements		579			579
Furniture and fixtures		319			319
	$	7,626		$	7,557
Less: Accumulated depreciation and amortization		(5,105	)		(4,511	)
	$	2,521		$	3,046

Depreciation and amortization expense for each of the three months ended September 30, 2022 and 2021 was $0.3 million. Depreciation and amortization expense for the nine months ended September 30, 2022 and 2021 was $0.8 million and $0.9 million, respectively.

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Accrued Expenses

9 Months Ended

Sep. 30, 2022

Payables and Accruals [Abstract]

Accrued Expenses

5. Accrued Expenses

Accrued expenses consisted of the following (in thousands):

	SEPTEMBER 30,		DECEMBER 31,
	2022		2021
Accrued external research, development and manufacturing costs	$	2,728	$	2,156
Accrued employee compensation and benefits		3,540		3,040
Other		1,555		1,614
	$	7,823	$	6,810

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Stock-Based Compensation

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

6. Stock-Based Compensation

The following table summarizes the Company’s stock option activity since December 31, 2021:

	NUMBER OF SHARES			WEIGHTED- AVERAGE EXERCISE PRICE		WEIGHTED- AVERAGE REMAINING CONTRACTUAL TERM		INTRINSIC VALUE
						(in years)		(in thousands)
Outstanding at December 31, 2021		4,339,523		$	9.75		7.68	$	8,823
Granted		2,541,920			5.75
Exercised		(14,757	)		1.95
Forfeited or canceled		(260,186	)		10.63
Outstanding at September 30, 2022		6,606,500		$	8.19		7.69	$	169
Vested and expected to vest at September 30, 2022		6,606,500		$	8.19		7.69	$	169
Options exercisable at September 30, 2022		2,825,300		$	7.97		5.94	$	169

Stock-Based Compensation Expense

Stock-based compensation expense related to stock options was classified in the consolidated statements of operations as follows (in thousands):

	THREE MONTHS ENDED SEPTEMBER 30,				NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021		2022		2021
Research and development expenses	$	1,034	$	1,423	$	2,563	$	2,670
General and administrative expenses		1,342		1,358		4,067		3,523
	$	2,376	$	2,781	$	6,630	$	6,193

As of September 30, 2022, total unrecognized stock-based compensation expense related to unvested stock-based awards was $19.3 million, which is expected to be recognized over a weighted-average period of 2.7 years.

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Income Taxes

9 Months Ended

Sep. 30, 2022

Income Tax Disclosure [Abstract]

Income Taxes

7. Income Taxes

For the three and nine months ended September 30, 2022 and 2021, the Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period, due to its uncertainty of realizing a benefit from those items. Substantially all of the Company’s operating losses since inception have been generated in the United States.

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Commitments and Contingencies

9 Months Ended

Sep. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

8. Commitments and Contingencies

Leases

The Company’s commitments under its leases are described in Note 9.

License and Supply Agreements

License Agreement with Massachusetts Institute of Technology

In December 2015, the Company entered into an exclusive patent license agreement with the Massachusetts Institute of Technology (“MIT”) (the “MIT Agreement”). The MIT Agreement replaced a May 2013 exclusive agreement with MIT. Under the MIT Agreement, the Company received an exclusive license under the licensed patent rights to develop, manufacture and commercialize any products related to certain intracellular delivery methods that were developed at MIT.

As of September 30, 2022 and December 31, 2021, the Company had no outstanding liabilities related to the MIT Agreement. During each of the three and nine months ended September 30, 2022 and 2021, the Company did not recognize any research and development expense under the sublicense terms of the MIT Agreement.

Manufacturing Services Agreements

The Company has entered into agreements with a contract manufacturing organization to provide manufacturing services related to its product candidates. As of September 30, 2022, the Company had no non-cancelable payments under these agreements, as amended, other than the amounts included in the current portion of operating lease liabilities on the Company's consolidated balance sheets.

401(k) Plan

The Company sponsors a 401(k) defined contribution benefit plan (the “401(k) Plan”), which covers all employees who meet certain eligibility requirements as defined in the 401(k) Plan and allows participants to defer a portion of their annual compensation on a pre-tax basis. Contributions to the 401(k) Plan may be made at the discretion of management. For the three months ended September 30, 2022 and 2021, the Company contributed $0.3 million and $0.1 million, respectively to the 401(k) Plan. For the nine months ended September 30, 2022 and 2021, the Company contributed $0.5 million and $0.2 million, respectively to the 401(k) Plan.

Indemnification Agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to its vendors, lessors, contract research organizations, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with its executive officers and members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or executive officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. The Company has not incurred any material costs as a result of such indemnification agreements and is not currently aware of any indemnification claims.

Legal Proceedings

The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings.

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Leases

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

Leases

9. Leases

As of September 30, 2022, the Company leases its office and laboratory facilities under a non-cancelable operating lease entered into in December 2018, which included lease incentives, payment escalations and rent holidays. In addition, the Company has an agreement entered into in April 2019 with a contract manufacturing supplier that is considered an embedded lease because the Company has substantially all the economic benefits of the related asset and can direct its use. The Company had not entered into any financing leases or any short-term operating leases as of September 30, 2022 and December 31, 2021.

The components of lease cost and other information for the Company’s lease portfolio were as follows (in thousands, except term and discount rate amounts):

	THREE MONTHS ENDED SEPTEMBER 30,				NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021		2022		2021
Lease cost:
Operating lease cost	$	3,347	$	3,430	$	10,867	$	9,965
Variable lease cost		454		425		1,424		1,428
	$	3,801	$	3,855	$	12,291	$	11,393

	SEPTEMBER 30, 2022			DECEMBER 31, 2021
Other information:
Weighted-average remaining lease term (in years)		5.5			6.2
Weighted-average discount rate		7.6	%		7.6	%

Supplemental cash flow information related to the Company’s operating leases was as follows (in thousands):

	NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021
Cash paid for amounts included in the measurement of operating lease liabilities:
Operating cash flows from operating leases	$	11,060	$	9,424

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License and Collaboration Agreements

9 Months Ended

Sep. 30, 2022

Research and Development [Abstract]

License and Collaboration Agreements

10. License and Collaboration Agreements

2017 License and Collaboration Agreement with Roche

In April 2017, the Company entered into a second license and collaboration agreement with Roche (the “2017 Roche Agreement”) to allow Roche to use the Company’s Cell Squeeze technology to enable gene editing of immune cells to discover new targets in cancer immunotherapy. The 2017 Roche Agreement included several licenses granted by Roche to the Company and by the Company to Roche in order to conduct a specified research program in accordance with a specified research plan. In the first quarter of 2022, the 2017 Roche Agreement was terminated and all active work streams under the 2017 Roche Agreement were concluded. As of December 31, 2021, the Company determined that it expected to incur no additional costs to satisfy the remaining performance obligations under the 2017 Roche Agreement and all remaining deferred revenue was recognized as of that date. There was no revenue recorded under this agreement during the three and nine months ended September 30, 2022.

During the three and nine months ended September 30, 2021, the total costs expected to be incurred to satisfy the performance obligation under the 2017 Roche Agreement decreased by $0.1 million and $0.4 million, respectively. The Company recognized revenue of $0.3 million and $1.0 million during the three and nine months ended September 30, 2021, respectively.

2018 License and Collaboration Agreement with Roche

In October 2018, the Company entered into a license and collaboration agreement with Roche (the “2018 Roche Agreement”) to jointly develop certain products based on mononuclear antigen presenting cells (“APCs”), including human papillomavirus (“HPV”), using the SQZ APC platform for the treatment of oncology indications. The Company granted Roche a non-exclusive license to its intellectual property, and Roche granted the Company a non-exclusive license to its and its affiliates’ intellectual property for the purpose of performing research activities. In connection with this agreement, the parties terminated an earlier agreement. The 2018 Roche Agreement has a term that extends until all royalty, profit-share and other payment obligations expire or have been satisfied. Roche has the right to terminate the 2018 Roche Agreement, in whole or on a product-by-product basis, upon a specified amount of notice to the Company. The Company or Roche may terminate the agreement if the other party fails to cure its material breach within a specified period after receiving notice of such breach.

Under the 2018 Roche Agreement, Roche was granted option rights to obtain an exclusive license to develop APC products or products derived from the collaboration programs on a product-by-product basis. These option rights are exercisable upon the achievement of clinical Phase 1 proof of concept and expire, if unexercised, as of a date specified in the agreement. In addition, Roche was granted an option right to obtain an exclusive license to develop a Tumor Cell Lysate (“TCL”) product. This option right is exercisable upon the achievement of clinical proof of concept and expires, if unexercised, as of a date specified in the agreement. For each of the APC products and TCL product, once Roche exercises its option and pays a specified incremental amount ranging from $15.0 million to $50.0 million for APC products and of $100.0 million for the TCL product, Roche will receive worldwide, exclusive commercialization rights for the licensed products, subject to the Company’s alternating option to retain U.S. APC commercialization rights. The Company will retain worldwide commercialization rights to any APC products or the TCL product for which Roche elects not to exercise its applicable option. For the first APC product that Roche exercises its option, Roche will receive worldwide, exclusive commercialization rights for the licensed product. On a product-by-product basis for the APC products, after the first product option is exercised by Roche and for every other product for which Roche exercises its option, the Company will retain an option to obtain the exclusive commercialization rights in the United States. Upon exercise of the TCL option by Roche, (i) the Company will be entitled to receive the aforementioned milestone payment of $100.0 million and (ii) profits from the TCL product will be shared equally by the Company and Roche. Through September 30, 2022, Roche had not exercised any of its options under the 2018 Roche Agreement.

Under the 2018 Roche Agreement, the Company received an upfront payment of $45.0 million and is eligible to receive (i) reimbursement of a mid-double-digit percentage of its development costs; (ii) aggregate milestone payments on a product-by-product basis of up to $1.6 billion upon the achievement of specified milestones, consisting of up to $217.0 million of development milestone payments, up to $240.0 million of regulatory milestone payments and up to $1.2 billion of sales milestone payments; and (iii) tiered royalties on annual net sales of APC and TCL products licensed under the agreement, as described below. The Company received the upfront payment of $45.0 million in October 2018 upon execution of the agreement. In addition, during the second quarter of 2019, the

Company received a payment of $10.0 million following the achievement of the first development milestone under the 2018 Roche Agreement related to submission by the Company of preclinical data to the U.S. Food and Drug Administration (“FDA”). During the first quarter of 2020, the Company received a payment of $20.0 million following the achievement of the second development milestone under the 2018 Roche Agreement related to first-patient dosing in a Phase 1 clinical trial. In the first quarter of 2022, the Company received a milestone payment of $3.0 million having achieved in the fourth quarter of 2021 the following: (i) the endorsement by an independent panel that it could advance its SQZ-PBMC-HPV clinical trial to combination therapy using checkpoint inhibitors and (ii) the initiation of that therapy.

Roche will pay tiered royalties based on annual net sales of APC and TCL products. If Roche exercises its option to obtain a license to commercialize an APC product, Roche will pay the Company tiered royalties on annual net sales of that licensed product at rates ranging from a mid-single-digit percentage to a mid-teens percentage, depending on net sales of the product. If the Company exercises its option to obtain a license to commercialize an APC product in the United States, it will pay Roche tiered royalties on annual net sales of that licensed product at rates ranging from a mid-single-digit percentage to a mid-teens percentage, depending on net sales of the product in the United States. For APC products selected by Roche, rather than mutually, Roche will pay the Company royalties on annual net sales of that licensed product at rates ranging from a mid-single-digit percentage to a high single-digit percentage, depending on net sales of the product. For APC products that are selected mutually and for which the Company has not exercised its option to commercialize the product in the United States, Roche will pay the Company tiered royalties on annual net sales of that licensed product at a rate ranging from a high single-digit percentage to a mid-teens percentage, depending on net sales of the product. For TCL products, Roche will pay the Company tiered royalties on the aggregate net sales of all TCL products at rates ranging from either a mid-single digit percentage to a percentage in the low twenties, with the caveat that the rates for sales in the United States may instead range from a low-teens percentage to a percentage in the mid-twenties, depending on whether and when the Company opts out of sharing certain profits and costs of commercializing the TCL product in the United States with Roche.

The Company identified three performance obligations at the outset of the 2018 Roche Agreement: (1) the license to the Company’s intellectual property, the research and development activities related to HPV through Phase 1 clinical trials under a specified research plan, and the manufacturing of the Company’s SQZ APC platform and equipment in order to support the HPV research plan (the “first performance obligation”); (2) the license to the Company’s intellectual property and the research and development activities on next-generation APCs (the “second performance obligation”); and (3) the license to the Company’s intellectual property and the research and development activities on TCL (the “third performance obligation”).

During the fourth quarter of 2019, the Company evaluated its overall program priorities and determined that it would continue to focus its resources on progressing the specified APC programs related to the 2018 Roche Agreement as well as its Activating Antigen Carriers (“AAC”) and Tolerizing Antigen Carriers (“TAC”) platforms. As a result of its continuing focus on these specific programs, the Company reduced the level of priority of the TCL research activities under the 2018 Roche Agreement and expects to perform such TCL research activities over a longer time period than as originally expected under the specified research plan of the agreement. Since the fourth quarter of 2019, the Company has classified $9.2 million as non-current deferred revenue, which will remain unrecognized as revenue until TCL research activities resume or the 2018 Roche Agreement is modified by the Company and Roche.

The Company separately recognizes revenue associated with each of the three performance obligations as the research, development and manufacturing services are provided using an input method, based on the cumulative costs incurred compared to the total estimated costs expected to be incurred to satisfy each performance obligation. The transfer of control to the customer occurs over the time period that the research and development services are to be provided by the Company, and this cost-to-cost method is, in management’s judgment, the best measure of progress towards satisfying each performance obligation. The amounts received that have not yet been recognized as revenue are deferred as a contract liability in the Company’s consolidated balance sheet and will be recognized over the remaining research and development period until each performance obligation is satisfied.

During the three and nine months ended September 30, 2022, there were no significant changes in the total estimated costs expected to be incurred to satisfy the performance obligations under the 2018 Roche Agreement. During the three and nine months ended September 30, 2021, the estimated costs expected to be incurred to satisfy the performance obligations increased by $0.4 million. The Company recognized revenue of $3.1 million and $4.5 million during the three months ended September 30, 2022 and 2021, respectively, under this agreement. The Company recognized revenue of $9.0 million and $13.6 million during the nine months ended September 30, 2022 and 2021, respectively, under this agreement. As of September 30, 2022, the Company recorded as a contract liability deferred revenue related to the 2018 Roche Agreement of $12.2 million, of which $3.0 million was a current liability. As of September 30, 2022, the research and development services related to the performance obligations were expected to be performed over a remaining period of three months. As of December 31, 2021, the Company recorded as a contract liability deferred revenue related to the 2018 Roche Agreement of $21.2 million, of which $12.0 million was a current liability.

As of September 30, 2022 and December 31, 2021, the expected remaining period of performance of the Company’s research and development services related to the third performance obligation was not determinable, and it will not become determinable until TCL research activities resume or the 2018 Roche Agreement is modified by the Company and Roche.

Contract Liability

The changes in the total contract liability (deferred revenue) balances related to the Company’s license and collaboration agreements were as follows (in thousands):

	THREE MONTHS ENDED SEPTEMBER 30,						NINE MONTHS ENDED SEPTEMBER 30,
	2022			2021			2022			2021
Balance at beginning of period	$	15,326		$	35,308		$	21,203		$	45,201
Recognition of deferred revenue		(3,130	)		(4,755	)		(9,011	)		(14,748	)
Other		—			—			4			100
Balance at end of period	$	12,196		$	30,553		$	12,196		$	30,553

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Net Loss per Share

9 Months Ended

Sep. 30, 2022

Earnings Per Share [Abstract]

Net Loss per Share

11. Net Loss per Share

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):

	THREE MONTHS ENDED SEPTEMBER 30,						NINE MONTHS ENDED SEPTEMBER 30,
	2022			2021			2022			2021
Numerator:
Net loss	$	(22,643	)	$	(22,450	)	$	(65,917	)	$	(56,919	)
Denominator:
Weighted-average common shares outstanding, basic and    diluted		29,284,151			28,050,130			28,603,020			27,421,839
Net loss per share attributable to common stockholders, basic and    diluted	$	(0.77	)	$	(0.80	)	$	(2.30	)	$	(2.08	)

The Company’s potential dilutive securities, which consist of common stock options have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

	THREE MONTHS ENDED SEPTEMBER 30,				NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021		2022		2021
Stock options to purchase common stock		6,606,500		4,527,642		6,606,500		4,527,642
		6,606,500		4,527,642		6,606,500		4,527,642

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Subsequent Events

9 Months Ended

Sep. 30, 2022

Subsequent Events [Abstract]

Subsequent Events

12. Subsequent Event

On November 1, 2022, as part of a transition to a more cost-effective manufacturing format, the Company provided notice to terminate its agreement with the contract manufacturing supplier referred to in Note 9, Leases. The agreement requires a nine-month prior written notice of termination, which results in an estimated termination date of July 31, 2023. As a result of the termination, the Company reduced its remaining lease payments by approximately $36.7 million. The termination will be accounted for as a lease modification in the three months ending December 31, 2022. The Company estimates the modification will reduce the right of use asset and lease liability by approximately $31.5 million.

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Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

Unaudited Interim Financial Information

Unaudited Interim Financial Information

The accompanying condensed consolidated financial statements as of September 30, 2022 and for the three and nine months ended September 30, 2022 and 2021 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. The accompanying condensed consolidated balance sheet as of December 31, 2021 was derived from audited financial statements but does not include all disclosures required by GAAP. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the SEC on March 16, 2022. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial position as of September 30, 2022, the consolidated results of operations for the three and nine months ended September 30, 2022 and 2021, and the consolidated cash flows for the nine months ended September 30, 2022 and 2021 have been made. The Company’s consolidated results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results of operations that may be expected for the full year or any other subsequent interim period.

Use of Estimates

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, revenue recognition, the accrual of research and development expenses, and the valuation of stock-based awards. 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. On an ongoing basis, management evaluates its estimates, judgments and methodologies as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions.

Segment Information

Segment Information

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is developing methods of engineering cell function and therapies for the treatment of patients across a range of indications. The Company has determined that its chief operating decision maker is its Chief Executive Officer. The Company’s chief operating decision maker reviews the Company’s financial information on a consolidated basis for purposes of allocating resources and assessing financial performance.

Revenue Recognition for Government Grants

Revenue Recognition for Government Grants

The Company generates revenue from government contracts that reimburse the Company for certain allowable costs for funded projects. For contracts with government agencies where the funding arrangement is considered central to the Company’s ongoing operations, the Company classifies the recognized funding received as revenue. Revenue from government grants is recognized as the qualifying expenses related to the contracts are incurred, provided that there is reasonable assurance of recoverability. The Company submits a budget, which outlines the expected project costs, to the funding government agency on a periodic basis. If the government agency approves the project proposed by the Company, the government agency generally funds the project upon receipt of the support for the costs incurred. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded as unbilled receivables, a component of prepaid expenses and other current assets, in the consolidated balance sheet. The related costs incurred by the Company are included in research and development expense in the Company’s consolidated statements of operations and comprehensive loss. In certain cases, the Company may obtain grants from an economic development agency that are not central to the Company's ongoing business. The income from these grants is recognized within Other income (expense), net in the consolidated statement of operations and comprehensive loss when there is reasonable assurance of recoverability.

Recently Issued Accounting Pronouncements

Recently Issued Accounting Pronouncements

The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company will adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and will do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company. The Company may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for nonpublic companies.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes will result in the earlier recognition of credit losses, if any. In May 2019, the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”), which provides additional implementation guidance on the previously issued ASU 2016-13. For the Company, both ASU 2016-13 and ASU 2019-05 are effective for fiscal years beginning after December 15, 2022. The Company is currently evaluating the impact that the adoption of ASU 2016-13 will have on its consolidated financial statements, however the Company does not expect that the standard will have a material impact on its consolidated financial statements.

In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes (Topic 740) (“ASU 2019-12”), which simplifies the accounting for income taxes by eliminating certain exceptions, including the approach for intraperiod tax allocation, the accounting for income taxes in an interim period, hybrid taxes and the recognition of deferred tax liabilities for outside basis differences. It also clarifies and simplifies other aspects of the accounting for income taxes. The Company adopted this standard as of January 1, 2022 and the standard did not have a material impact on its consolidated financial statements.

In November 2021, the FASB issued ASU 2021-10, Disclosures by Business Entities about Government Assistance, which requires business entities to provide certain disclosures when they have 1) received government assistance and 2) use a grant or contribution accounting model by analogy to other accounting guidance. The Company adopted this standard as of January 1, 2022 and the standard did not have a material impact on its consolidated financial statements.

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Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2022

Fair Value Disclosures [Abstract]

Summary of fair value hierarchy for assets and liabilities

The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands):

	FAIR VALUE MEASUREMENTS AT SEPTEMBER 30, 2022 USING:
	LEVEL 1		LEVEL 2		LEVEL 3		TOTAL
Assets:
Cash equivalents:
Money market funds	$	83,107	$	—	$	—	$	83,107
	$	83,107	$	—	$	—	$	83,107

	FAIR VALUE MEASUREMENTS AT DECEMBER 31, 2021 USING:
	LEVEL 1		LEVEL 2		LEVEL 3		TOTAL
Assets:
Cash equivalents:
Money market funds	$	142,547	$	—	$	—	$	142,547
	$	142,547	$	—	$	—	$	142,547

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Property and Equipment, Net (Tables)

9 Months Ended

Sep. 30, 2022

Property, Plant and Equipment, Net [Abstract]

Summary of property and equipment, net

Property and equipment, net consisted of the following (in thousands):

	SEPTEMBER 30,			DECEMBER 31,
	2022			2021
Machinery and equipment	$	6,728		$	6,659
Leasehold improvements		579			579
Furniture and fixtures		319			319
	$	7,626		$	7,557
Less: Accumulated depreciation and amortization		(5,105	)		(4,511	)
	$	2,521		$	3,046

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Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2022

Payables and Accruals [Abstract]

Summary of accrued expenses

Accrued expenses consisted of the following (in thousands):

	SEPTEMBER 30,		DECEMBER 31,
	2022		2021
Accrued external research, development and manufacturing costs	$	2,728	$	2,156
Accrued employee compensation and benefits		3,540		3,040
Other		1,555		1,614
	$	7,823	$	6,810

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Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement [Abstract]

Summary of Stock Option Activity

The following table summarizes the Company’s stock option activity since December 31, 2021:

	NUMBER OF SHARES			WEIGHTED- AVERAGE EXERCISE PRICE		WEIGHTED- AVERAGE REMAINING CONTRACTUAL TERM		INTRINSIC VALUE
						(in years)		(in thousands)
Outstanding at December 31, 2021		4,339,523		$	9.75		7.68	$	8,823
Granted		2,541,920			5.75
Exercised		(14,757	)		1.95
Forfeited or canceled		(260,186	)		10.63
Outstanding at September 30, 2022		6,606,500		$	8.19		7.69	$	169
Vested and expected to vest at September 30, 2022		6,606,500		$	8.19		7.69	$	169
Options exercisable at September 30, 2022		2,825,300		$	7.97		5.94	$	169

Summary of Stock-Based Compensation Expense

Stock-based compensation expense related to stock options was classified in the consolidated statements of operations as follows (in thousands):

	THREE MONTHS ENDED SEPTEMBER 30,				NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021		2022		2021
Research and development expenses	$	1,034	$	1,423	$	2,563	$	2,670
General and administrative expenses		1,342		1,358		4,067		3,523
	$	2,376	$	2,781	$	6,630	$	6,193

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Leases (Tables)

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

Summary of Components of Lease Cost and Other Information

The components of lease cost and other information for the Company’s lease portfolio were as follows (in thousands, except term and discount rate amounts):

	THREE MONTHS ENDED SEPTEMBER 30,				NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021		2022		2021
Lease cost:
Operating lease cost	$	3,347	$	3,430	$	10,867	$	9,965
Variable lease cost		454		425		1,424		1,428
	$	3,801	$	3,855	$	12,291	$	11,393

	SEPTEMBER 30, 2022			DECEMBER 31, 2021
Other information:
Weighted-average remaining lease term (in years)		5.5			6.2
Weighted-average discount rate		7.6	%		7.6	%

Summary of Supplementary Cash Flow Information Relating to Operating Leases

Supplemental cash flow information related to the Company’s operating leases was as follows (in thousands):

	NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021
Cash paid for amounts included in the measurement of operating lease liabilities:
Operating cash flows from operating leases	$	11,060	$	9,424

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License and Collaboration Agreements (Tables)

9 Months Ended

Sep. 30, 2022

Research and Development [Abstract]

Summary of Changes in the Total Contract Liability

The changes in the total contract liability (deferred revenue) balances related to the Company’s license and collaboration agreements were as follows (in thousands):

	THREE MONTHS ENDED SEPTEMBER 30,						NINE MONTHS ENDED SEPTEMBER 30,
	2022			2021			2022			2021
Balance at beginning of period	$	15,326		$	35,308		$	21,203		$	45,201
Recognition of deferred revenue		(3,130	)		(4,755	)		(9,011	)		(14,748	)
Other		—			—			4			100
Balance at end of period	$	12,196		$	30,553		$	12,196		$	30,553

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Net Loss per Share (Tables)

9 Months Ended

Sep. 30, 2022

Earnings Per Share [Abstract]

Summary of basic and diluted net loss per share attributable to common stockholders

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):

	THREE MONTHS ENDED SEPTEMBER 30,						NINE MONTHS ENDED SEPTEMBER 30,
	2022			2021			2022			2021
Numerator:
Net loss	$	(22,643	)	$	(22,450	)	$	(65,917	)	$	(56,919	)
Denominator:
Weighted-average common shares outstanding, basic and    diluted		29,284,151			28,050,130			28,603,020			27,421,839
Net loss per share attributable to common stockholders, basic and    diluted	$	(0.77	)	$	(0.80	)	$	(2.30	)	$	(2.08	)

Summary of potentially dilutive shares excluded from the calculation of diluted net loss

The Company’s potential dilutive securities, which consist of common stock options have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

	THREE MONTHS ENDED SEPTEMBER 30,				NINE MONTHS ENDED SEPTEMBER 30,
	2022		2021		2022		2021
Stock options to purchase common stock		6,606,500		4,527,642		6,606,500		4,527,642
		6,606,500		4,527,642		6,606,500		4,527,642

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Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($)	9 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Proceeds from issuance of common stock under at-the market offering	$ 3,762,000
Number of shares sold at-the-market offering facility	1,160,768
Income (loss) from continuing operations	$ (65,900,000)
Accumulated deficit	261,427,000	$ 195,510,000
Follow-on Offering [Member]
Proceeds from follow on public offer net of underwriting discounts and before payment of offering costs	3,700,000
Follow-on Offering [Member] | Maximum [Member]
Proceeds from issuance of common stock under at-the market offering	$ 75,000,000

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Fair Value Measurements - Summary of Fair Value Hierarchy for Assets and Liabilities (Detail) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Assets:
Assets, fair value disclosure	$ 83,107	$ 142,547
Level 1 [Member]
Assets:
Assets, fair value disclosure	83,107	142,547
Money Market Funds [Member] | Cash equivalents [Member]
Assets:
Assets, fair value disclosure	83,107	142,547
Money Market Funds [Member] | Cash equivalents [Member] | Level 1 [Member]
Assets:
Assets, fair value disclosure	$ 83,107	$ 142,547

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Fair Value Measurements - Additional Information (Details)	Sep. 30, 2022 USD ($)
Fair Value Disclosures [Abstract]
Fair value, assets, level 1 to level 2 transfers, amount	$ 0
Fair value, assets, level 2 to level 1 transfers, amount	0
Fair value, liabilities, level 1 to level 2 transfers, amount	0
Fair value, liabilities, level 2 to level 1 transfers, amount	0
Fair value, assets, level 1 to level 3 transfers, amount	0
Fair value, assets, level 2 to level 3 transfers, amount	0
Fair value, assets, level 3 to level 1 transfers, amount	0
Fair value, assets, level 3 to level 2 transfers, amount	0
Fair value, liabilities, level 1 to level 3 transfers, amount	0
Fair value, liabilities, level 2 to level 3 transfers, amount	0
Fair value, liabilities, level 3 to level 1 transfers, amount	0
Fair value, liabilities, level 3 to level 2 transfers, amount	$ 0

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Property and Equipment, Net - Summary of Property and Equipment, Net (Detail) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Property, Plant and Equipment, Net [Abstract]
Machinery and equipment	$ 6,728	$ 6,659
Leasehold improvements	579	579
Furniture and fixtures	319	319
Total property and equipment, gross	7,626	7,557
Less: Accumulated depreciation and amortization	(5,105)	(4,511)
Total property and equipment, net	$ 2,521	$ 3,046

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Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Property, Plant and Equipment [Line Items]
Depreciation and amortization expense	$ 300	$ 300	$ 833	$ 932

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Accrued Expenses - Summary of Accrued Expenses (Detail) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Payables and Accruals [Abstract]
Accrued external research, development and manufacturing costs	$ 2,728	$ 2,156
Accrued employee compensation and benefits	3,540	3,040
Other	1,555	1,614
Total accrued expenses	$ 7,823	$ 6,810

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Stock-Based Compensation - Additional Information (Detail) $ in Millions	9 Months Ended
	Sep. 30, 2022 USD ($)
Stockbased Compensation [Line Items]
Unrecognized compensation expense related to unvested stock based awards	$ 19.3
Unrecognized compensation expense expected period for recognition	2 years 8 months 12 days

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Stock-Based Compensation - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Share-Based Payment Arrangement [Abstract]
Number of Shares - Outstanding at December 31, 2021	4,339,523
Granted	2,541,920
Exercised	(14,757)
Forfeited or canceled	(260,186)
Number of Shares - Outstanding at September 30, 2022	6,606,500	4,339,523
Number of Shares - Vested and expected to vest at September 30, 2022	6,606,500
Number of Shares - Options exercisable at September 30, 2022	2,825,300
Weighted Average Exercise Price - Outstanding at December 31, 2021	$ 9.75
Granted	5.75
Exercised	1.95
Forfeited or canceled	10.63
Weighted Average Exercise Price - Outstanding at September 30, 2022	8.19	$ 9.75
Weighted Average Exercise Price - Vested and expected to vest at September 30, 2022	8.19
Weighted Average Exercise Price - Options exercisable at September 30, 2022	$ 7.97
Weighted-Average Remaining Contractual Term	7 years 8 months 8 days	7 years 8 months 4 days
Weighted-Average Remaining Contractual Term - Vested and expected to vest	7 years 8 months 8 days
Weighted-Average Remaining Contractual Term - Options exercisable	5 years 11 months 8 days
Aggregate Intrinsic Value - Outstanding	$ 169	$ 8,823
Aggregate Intrinsic Value - Vested and expected to vest	169
Aggregate Intrinsic Value - Options exercisable	$ 169

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Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 2,376	$ 2,781	$ 6,630	$ 6,193
Research and Development Expense [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	1,034	1,423	2,563	2,670
General and Administrative Expense [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 1,342	$ 1,358	$ 4,067	$ 3,523

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Income Taxes - Additional Information (Detail) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Income Tax Disclosure [Abstract]
Income tax benefits	$ 0	$ 0	$ 0	$ 0

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Commitments and Contingencies - Additional Information (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Other Commitments [Line Items]
Commitments and contingencies (Note 8)
Research and development	19,631,000	$ 20,520,000	55,401,000	$ 52,942,000
Discretionary contribution by the employer to defined contribution benefit plan	300,000	100,000	500,000	200,000
Manufacturing Services Agreements [Member]
Other Commitments [Line Items]
Non-cancelable payments	0		0
Sublicense Agreement [Member]
Other Commitments [Line Items]
Research and development	0	$ 0	0	$ 0
Massachusetts Institute Of Technology
Other Commitments [Line Items]
Commitments and contingencies (Note 8)	$ 0		$ 0		$ 0

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Leases - Summary of Components of Lease Cost and Other Information (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Lease cost:
Operating lease cost	$ 3,347	$ 3,430	$ 10,867	$ 9,965
Variable lease cost	454	425	1,424	1,428
Lease Cost	$ 3,801	$ 3,855	$ 12,291	$ 11,393
Other information:
Weighted-average remaining lease term (in years)	5 years 6 months		5 years 6 months		6 years 2 months 12 days
Weighted-average discount rate	7.60%		7.60%		7.60%

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Leases - Summary of Supplementary Cash Flow Information Relating to Operating Leases (Detail) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Leases [Abstract]
Operating cash flows from operating leases	$ 11,060	$ 9,424

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License and Collaboration Agreements - Additional Information (Detail) - USD ($)	1 Months Ended	3 Months Ended						9 Months Ended
	Oct. 31, 2018	Sep. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Mar. 31, 2020	Dec. 31, 2019	Jun. 30, 2019	Sep. 30, 2022	Sep. 30, 2021	Jun. 30, 2022	Dec. 31, 2021	Jun. 30, 2021	Dec. 31, 2020
License And Collaboration Agreements [Line Items]
Estimated costs to be incurred to satisfy performance obligation				$ 400,000					$ 400,000
Contract with customer liability revenue recognized		$ 3,130,000		4,755,000				$ 9,011,000	14,748,000
Estimated Costs To Be Incurred To Satisfy Performance Obligation				400,000					400,000
Contract with customer liability		12,196,000		30,553,000				12,196,000	30,553,000	$ 15,326,000	$ 21,203,000	$ 35,308,000	$ 45,201,000
2017 License and Collaboration Agreement With Roche [Member] | Roche [Member]
License And Collaboration Agreements [Line Items]
Estimated costs to be incurred to satisfy performance obligation				100,000					400,000
Contract with customer liability revenue recognized		0		300,000				0	1,000,000.0
Estimated Costs To Be Incurred To Satisfy Performance Obligation				100,000					400,000
2018 License and Collaboration Agreement With Roche [Member]
License And Collaboration Agreements [Line Items]
Milestone payment receivable on exercise of option rights		100,000,000.0						100,000,000.0
2018 License and Collaboration Agreement With Roche [Member] | Roche [Member]
License And Collaboration Agreements [Line Items]
Upfront payment received towards technology access fee	$ 45,000,000.0
Estimated costs to be incurred to satisfy performance obligation		0		0				0	0
Contract with customer liability current		3,000,000.0						3,000,000.0			12,000,000.0
Milestone payment receivable based on product		1,600,000						1,600,000
Milestone payment received			$ 3,000.0
Performance obligation revenue recognized		3,100,000		4,500,000				9,000,000.0	13,600
Estimated Costs To Be Incurred To Satisfy Performance Obligation		0		$ 0				0	$ 0
Contract with customer liability		12,200,000						12,200,000			$ 21,200,000
2018 License and Collaboration Agreement With Roche [Member] | Roche [Member] | Development Milestone [Member]
License And Collaboration Agreements [Line Items]
Milestone payment receivable based on product		217,000,000.0						217,000,000.0
2018 License and Collaboration Agreement With Roche [Member] | Roche [Member] | Development Milestone [Member] | First Patient Doosing Phase One Clinical Trial [Member]
License And Collaboration Agreements [Line Items]
Milestone payment received					$ 20,000,000.0
2018 License and Collaboration Agreement With Roche [Member] | Roche [Member] | Regulatory Milestone [Member]
License And Collaboration Agreements [Line Items]
Milestone payment receivable based on product		240,000,000.0						240,000,000.0
2018 License and Collaboration Agreement With Roche [Member] | Roche [Member] | Regulatory Milestone [Member] | Preclinical Data Submitted To FDA For Approval [Member]
License And Collaboration Agreements [Line Items]
Milestone payment received							$ 10,000,000.0
2018 License and Collaboration Agreement With Roche [Member] | Roche [Member] | Sales Milestone [Member]
License And Collaboration Agreements [Line Items]
Milestone payment receivable based on product		1,200,000,000						1,200,000,000
2018 License and Collaboration Agreement With Roche [Member] | Roche [Member] | APC [Member]
License And Collaboration Agreements [Line Items]
Amount payable on exercise of option rights to use the license		15,000,000.0						15,000,000.0
2018 License and Collaboration Agreement With Roche [Member] | Roche [Member] | TCL [Member]
License And Collaboration Agreements [Line Items]
Contract liabilities current reclassified to non current						$ 9,200,000
2018 License and Collaboration Agreement With Roche [Member] | Roche [Member] | Maximum [Member] | TCL [Member]
License And Collaboration Agreements [Line Items]
Amount payable on exercise of option rights to use the license		100,000,000.0						100,000,000.0
2018 License and Collaboration Agreement With Roche [Member] | Roche [Member] | Minimum [Member] | TCL [Member]
License And Collaboration Agreements [Line Items]
Amount payable on exercise of option rights to use the license		$ 50,000,000.0						$ 50,000,000.0

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License and Collaboration Agreements - Additional Information (Detail1)	Sep. 30, 2022
2018 License and Collaboration Agreement With Roche [Member] | Roche [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2022-10-01
License And Collaboration Agreements [Line Items]
Remaining period over which the performance obligation is to be satisfied	3 months

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License and Collaboration Agreements - Summary of Changes in the Total Contract Liability (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Research and Development [Abstract]
Balance at beginning of period	$ 15,326	$ 35,308	$ 21,203	$ 45,201
Recognition of deferred revenue	(3,130)	(4,755)	(9,011)	(14,748)
Other			4	100
Balance at end of period	$ 12,196	$ 30,553	$ 12,196	$ 30,553

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Net Loss Per Share - Summary of basic and diluted net loss per share attributable to common stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Earnings Per Share [Abstract]
Net loss	$ (22,643)	$ (22,450)	$ (65,917)	$ (56,919)
Weighted-average common shares outstanding, basic	29,284,151	28,050,130	28,603,020	27,421,839
Weighted-average common shares outstanding, diluted	29,284,151	28,050,130	28,603,020	27,421,839
Net loss per share attributable to common stockholders, basic	$ (0.77)	$ (0.80)	$ (2.30)	$ (2.08)
Net loss per share attributable to common stockholders, diluted	$ (0.77)	$ (0.80)	$ (2.30)	$ (2.08)

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Net Loss Per Share - Summary of potentially dilutive shares excluded from the calculation of diluted net loss (Detail) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share amount	6,606,500	4,527,642	6,606,500	4,527,642
Share-based Payment Arrangement, Option [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share amount	6,606,500	4,527,642	6,606,500	4,527,642

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Subsequent Events - Additional Information (Detail) - USD ($) $ in Thousands	Nov. 01, 2022	Sep. 30, 2022	Dec. 31, 2021
Subsequent Event [Line Items]
Operating lease right-of-use assets		$ 62,385	$ 69,843
Subsequent Event [Member]
Subsequent Event [Line Items]
Operating lease right-of-use assets	$ 31,500
Lease liability	31,500
Lease modification decrease in remaining operating lease payments	$ 36,700