UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

________________________________

FORM 10-Q

________________________________


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

For the quarterly period ended June 30, ~~2021~~2022


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

Commission File Number: 001-33958

SELLAS Life Sciences Group, Inc.

(Exact name of registrant as specified in its charter)


Delaware						20-8099512
(State of incorporation)						(I.R.S. Employer Identification No.)

7 Times Square, Suite 2503, New York, NY 10036

(646) 200-5278

(Address, including zip code, and telephone number, including

area code, of registrant's principal executive offices)

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


Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value per share	SLS	The Nasdaq Stock Market LLC

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 time 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 August ~~12, 2021,~~10, 2022, SELLAS Life Sciences Group, Inc. had outstanding ~~15,873,941~~20,551,918 shares of common stock.

SELLAS LIFE SCIENCES GROUP, INC.

FORM 10-Q - Quarterly Report

For the Quarter Ended June 30, ~~2021~~2022

TABLE OF CONTENTS


		Page
	PART I - FINANCIAL INFORMATION
Item 1	Financial Statements	3
	Unaudited Consolidated Balance Sheets Asas of June 30, ~~2021~~2022 and December 31, ~~2020~~2021	3
	Unaudited Consolidated Statements of Operations F orfor the T ~~hree~~Three and S ix M ~~onths~~ E ~~nded~~Six Months Ended June 30, ~~2021~~2022 and ~~2020~~2021	4
	Unaudited Consolidated Statements of Stockholders' Equity ~~For~~for the Three and Six Months Ended June 30, ~~2021~~2022 and ~~2020~~2021	5
	Unaudited Consolidated Statements of Cash Flows F orfor the S ix M ~~onths~~ E ~~nded~~Six Months Ended June 30, ~~2021~~2022 and ~~2020~~2021	6
	Unaudited Notes to Consolidated Financial Statements	7
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2221
Item 3	Quantitative and Qualitative Disclosures About Market Risk	3132
Item 4	Controls and Procedures	3132
	PART II - OTHER INFORMATION
Item 1	Legal Proceedings	3234
Item 1A	Risk Factors	3234
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	3234
Item 3	Defaults Upon Senior Securities	3234
Item 4	Mine Safety Disclosures	3234
Item 5	Other Information	3234
Item 6	Exhibits	3234

	Signatures

The names “SELLAS Life Sciences Group, Inc.,” “SELLAS,” the SELLAS logo, and other trademarks or service marks of SELLAS Life Sciences Group, Inc. appearing in this Quarterly Report on Form 10-Q are the property of SELLAS Life Sciences Group, Inc. Other trademarks, service marks or trade names appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. We do not intend the use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of or by either of, these other companies.

Unless the context otherwise indicates, references in these notes to the “Company,” “we,” “us” or “our” refer to SELLAS Life Sciences Group, Inc. and its wholly owned subsidiaries.

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS

This Quarterly Report on Form 10-Q includes forward-looking statements that reflect our current views with respect to our development programs, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and our industry, in general. Such forward-looking statements include the words "expect," "intend,” "plan," "believe," "project," "estimate,” "may,” "should," "anticipate," "will" and similar statements of a future or forward-looking nature identify forward-looking statements.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. The COVID-19 pandemic has caused a widespread global health crisis that could adversely affect the economies and financial markets of many countries, resulting in an economic downturn that could impact our operating results. We expect the COVID-19 pandemic tomay continue to have both a direct and an indirect impact on our business operations and financial results ~~however,~~and the business operations of our partners and collaborators, including direct and indirect economic effects as a result of inflation, supply chain disruptions and labor shortages. The extent of the impact on our clinical development and regulatory efforts and those of our partners and collaborators, our corporate development objectives, our financial position and the value of and market for our common stock will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, including infection rate and hospitalizations, the emergence of new variants, ~~of COVID-19, the emergence of new geographic hotspots where the coronavirus is spreading more rapidly,~~ travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, ~~as well as~~including the European Union and China, and the effectiveness of actions taken globally to contain and treat the disease, including the availability of safe and effective vaccines and the uptake ~~thereof, and whether existing vaccines are effective with respect to new variants.~~thereof. There are or will be important factors that could cause actual results to differ materially from those indicated in these statements. These factors include, but are not limited to, those factors set forth in the sections captioned "Business – Overview,” “Risk Factors,” “Legal Proceedings,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in this Quarterly Report on Form 10-Q, in our Annual Report on Form 10-K for the year ended December 31, ~~2020~~2021 as filed with the Securities and Exchange Commission ("SEC") on March ~~23,~~ 31, 2022 ("2021 ~~("2020~~ Annual Report") and in our other public filings with the SEC, all of which you should review carefully. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

PART I FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

SELLAS LIFE SCIENCES GROUP, INC.

CONSOLIDATED BALANCE SHEETS

(Amounts in thousands, except share and per share data)

(Unaudited)


		June 30, 2021		December 31, 2020			June 30, 2022			December 31, 2021

ASSETS	ASSETS								ASSETS
Current assets:	Current assets:					Current assets:
Cash and cash equivalents	Cash and cash equivalents	$	29,917	$	35,302	Cash and cash equivalents	$	26,987		$	21,355
Restricted cash and cash equivalents	Restricted cash and cash equivalents	100		100		Restricted cash and cash equivalents	100			100
Stock subscription receivable		2,240		0

Contract asset		0		1,128
Prepaid expenses and other current assets	Prepaid expenses and other current assets	2,318		395		Prepaid expenses and other current assets	1,650			1,589

Total current assets	Total current assets	34,575		36,925		Total current assets	28,737			23,044

Operating lease right-of-use asset		812		896
In-process research and development		5,700		5,700

Operating lease right-of-use assets						Operating lease right-of-use assets	1,045			723
Goodwill	Goodwill	1,914		1,914		Goodwill	1,914			1,914
Deposits and other assets	Deposits and other assets	623		614		Deposits and other assets	514			594
Total assets	Total assets	$	43,624	$	46,049	Total assets	$	32,210		$	26,275
LIABILITIES AND STOCKHOLDERS’ EQUITY	LIABILITIES AND STOCKHOLDERS’ EQUITY					LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:	Current liabilities:					Current liabilities:

Accounts payable	Accounts payable	$	2,276	$	4,657	Accounts payable	$	3,339		$	2,144
Accrued expenses and other current liabilities	Accrued expenses and other current liabilities	1,781		1,913		Accrued expenses and other current liabilities	3,006			2,640

Operating lease liability		182		166
Deferred revenue		0		5,600

Operating lease liabilities						Operating lease liabilities	341			198
Acquired in-process research and development payable						Acquired in-process research and development payable	5,500			—
Total current liabilities	Total current liabilities	4,239		12,336		Total current liabilities	12,186			4,982

Operating lease liability, non-current		721		825
Deferred tax liability		239		239
Operating lease liabilities, non-current						Operating lease liabilities, non-current	783			610
Warrant liability	Warrant liability	114		55		Warrant liability	3			40
Contingent consideration	Contingent consideration	4,896		4,633		Contingent consideration	181			296

Total liabilities	Total liabilities	10,209		18,088		Total liabilities	13,153			5,928
Commitments and contingencies (Note 6)		0		0
Commitments and contingencies (Note 7)						Commitments and contingencies (Note 7)	0			0
Stockholders’ equity:	Stockholders’ equity:					Stockholders’ equity:
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; Series A convertible preferred stock, 17,500 shares designated; 0 shares issued and outstanding at June 30, 2021 and December 31, 2020		0		0
Common stock, $0.0001 par value; 350,000,000 shares authorized, 15,873,941 and 14,254,554 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively.		2		1
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; Series A convertible preferred stock, 17,500 shares designated; no shares issued and outstanding at June 30, 2022 and December 31, 2021						Preferred stock, $0.0001 par value; 5,000,000 shares authorized; Series A convertible preferred stock, 17,500 shares designated; no shares issued and outstanding at June 30, 2022 and December 31, 2021	—			—
Common stock, $0.0001 par value; 350,000,000 shares authorized, 20,551,918 and 15,895,637 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively						Common stock, $0.0001 par value; 350,000,000 shares authorized, 20,551,918 and 15,895,637 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively	2			2
Additional paid-in capital	Additional paid-in capital	158,333		145,864		Additional paid-in capital	182,816			158,948
Accumulated deficit	Accumulated deficit	(124,920)		(117,904)		Accumulated deficit	(163,761)			(138,603)

Total stockholders’ equity	Total stockholders’ equity	33,415		27,961		Total stockholders’ equity	19,057			20,347
Total liabilities and stockholders’ equity	Total liabilities and stockholders’ equity	$	43,624	$	46,049	Total liabilities and stockholders’ equity	$	32,210		$	26,275

See accompanying notes to these unaudited consolidated financial statements.

Table of Contents

SELLAS LIFE SCIENCES GROUP, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands, except share and per share data)

(Unaudited)


		Three Months Ended June 30,				Six Months Ended June 30,					Three Months Ended June 30,				Six Months Ended June 30,
		2021		2020		2021		2020			2022		2021		2022		2021
Licensing revenue	Licensing revenue	$	1,900	$	0	$	7,600	$	0	Licensing revenue	$	—	$	1,900	$	1,000	$	7,600
Operating expenses:	Operating expenses:									Operating expenses:
Cost of licensing revenue	Cost of licensing revenue	100		0		200		0		Cost of licensing revenue	—		100		100		200
Research and development	Research and development	3,456		2,280		7,740		4,144		Research and development	5,529		3,456		10,140		7,740
Acquired in-process research and development										Acquired in-process research and development	—		—		10,000		—
General and administrative	General and administrative	2,797		1,987		6,358		4,187		General and administrative	3,094		2,797		6,118		6,358

Total operating expenses	Total operating expenses	6,353		4,267		14,298		8,331		Total operating expenses	8,623		6,353		26,358		14,298
Operating loss	Operating loss	(4,453)		(4,267)		(6,698)		(8,331)		Operating loss	(8,623)		(4,453)		(25,358)		(6,698)
Non-operating income (expense), net:	Non-operating income (expense), net:									Non-operating income (expense), net:

Change in fair value of warrant liability	Change in fair value of warrant liability	(28)		(16)		(59)		19		Change in fair value of warrant liability	48		(28)		37		(59)

Change in fair value of contingent consideration	Change in fair value of contingent consideration	(134)		(143)		(263)		(281)		Change in fair value of contingent consideration	115		(134)		115		(263)

Interest income	Interest income	2		1		4		25		Interest income	46		2		48		4
Total non-operating expense, net		(160)		(158)		(318)		(237)

Total non-operating income (expense), net										Total non-operating income (expense), net	209		(160)		200		(318)
Net loss	Net loss	(4,613)		(4,425)		(7,016)		(8,568)		Net loss	$	(8,414)	$	(4,613)	$	(25,158)	$	(7,016)

Deemed dividend arising from warrant modifications		0		0		0		(78)
Net loss attributable to common stockholders		$	(4,613)	$	(4,425)	$	(7,016)	$	(8,646)

Per share information:	Per share information:									Per share information:

Net loss per common share attributable to common stockholders, basic and diluted		$	(0.30)	$	(0.66)	$	(0.47)	$	(1.32)
Net loss per common share, basic and diluted										Net loss per common share, basic and diluted	$	(0.41)	$	(0.30)	$	(1.39)	$	(0.47)
Weighted-average common shares outstanding, basic and diluted	Weighted-average common shares outstanding, basic and diluted	15,270,288		6,717,900		15,074,887		6,546,440		Weighted-average common shares outstanding, basic and diluted	20,286,624		15,270,288		18,104,176		15,074,887

See accompanying notes to these unaudited consolidated financial statements.

Table of Contents

SELLAS LIFE SCIENCES GROUP, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

(Amounts in thousands, except share amounts)

(Unaudited)


		Three Months Ended June 30, 2021
	Common Stock		Additional Paid-In Capital			Accumulated Deficit				Total Stockholders' Equity (Deficit)
		Shares			Amount
Balance at March 31, 2021		15,084,754	$	2		$	149,047	$	(120,307)		$	28,742
Issuance of common stock and common stock warrants, net of issuance costs		786,927	—			9,005		—			9,005
Issuance of common stock upon exercise of warrants, net of offering costs		2,260	—			17		—			17

Stock-based compensation		—	—			264		—			264
Net loss		—	—			—		(4,613)			(4,613)
Balance at June 30, 2021		15,873,941	$	2		$	158,333	$	(124,920)		$	33,415

		Six Months Ended June 30, 2021
	Common Stock		Additional Paid-In Capital			Accumulated Deficit				Total Stockholders' Equity
		Shares			Amount
Balance at December 31, 2020		14,254,554	$	1		$	145,864	$	(117,904)		$	27,961
Issuance of common stock and common stock warrants, net of issuance costs		786,927	—			9,005		—			9,005

														Three Months Ended June 30, 2022
														Common Stock			Additional Paid-In Capital				Accumulated Deficit				Total Stockholders' Equity
														Shares	Amount
Balance at March 31, 2022													Balance at March 31, 2022	15,905,999	$	2			$	159,370			$	(155,347)			$	4,025
Issuance of common stock and common stock warrants, net of issuance costs													Issuance of common stock and common stock warrants, net of issuance costs	4,645,919	—		22,996				—				22,996

Stock-based compensation													Stock-based compensation	—	—		450				—				450
Net loss													Net loss	—	—		—				(8,414)				(8,414)
Balance at June 30, 2022													Balance at June 30, 2022	20,551,918	$	2	$	182,816			$	(163,761)			$	19,057

														Six Months Ended June 30, 2022
														Common Stock			Additional Paid-In Capital				Accumulated Deficit				Total Stockholders' Equity
														Shares	Amount
Balance at December 31, 2021													Balance at December 31, 2021	15,895,637	$	2			$	158,948			$	(138,603)			$	20,347
Issuance of common stock and common stock warrants, net of issuance costs													Issuance of common stock and common stock warrants, net of issuance costs	4,645,919	—		22,996				—				22,996

Issuance of common stock under employee stock purchase plan													Issuance of common stock under employee stock purchase plan	10,362	—		47				—				47
Stock-based compensation													Stock-based compensation	—	—		825				—				825
Net loss													Net loss	—	—		—				(25,158)				(25,158)
Balance at June 30, 2022													Balance at June 30, 2022	20,551,918	$	2	$	182,816			$	(163,761)			$	19,057

Issuance of common stock upon exercise of warrants		832,460	1			3,016		—			3,017

Stock-based compensation		—	—			448		—			448

Net loss		—	—			—		(7,016)			(7,016)
Balance at June 30, 2021		15,873,941	$	2		$	158,333	$	(124,920)		$	33,415


			Three Months Ended June 30, 2020									Three Months Ended June 30, 2021
		Common Stock		Additional Paid-In Capital			Accumulated Deficit				Total Stockholders' Equity (Deficit)	Common Stock					Additional Paid-In Capital		Accumulated Deficit					Total Stockholders' Equity
			Shares			Amount										Shares											Total Stockholders' Equity
Balance at March 31, 2020			6,717,900	$	1		$	113,351	$	(105,290)			$	8,062
Balance at March 31, 2021															Balance at March 31, 2021	15,084,754	$	2				$	149,047					$	(120,307)			$	28,742
Issuance of common stock and common stock warrants, net of issuance costs															Issuance of common stock and common stock warrants, net of issuance costs	786,927	—		9,005					—				9,005
Issuance of common stock upon exercise of warrants															Issuance of common stock upon exercise of warrants	2,260	—		17					—				17
Stock-based compensation															Stock-based compensation	—	—		264					—				264
Net loss															Net loss	—	—		—					(4,613)				(4,613)
Balance at June 30, 2021															Balance at June 30, 2021	15,873,941	$	2	$	158,333				$	(124,920)			$	33,415

																Six Months Ended June 30, 2021
																Common Stock			Additional Paid-In Capital					Accumulated Deficit				Total Stockholders' Equity
																Shares	Amount

Balance at December 31, 2020															Balance at December 31, 2020	14,254,554	$	1			$	145,864				$	(117,904)			$	27,961
Issuance of common stock and common stock warrants, net of issuance costs															Issuance of common stock and common stock warrants, net of issuance costs	786,927	—		9,005					—				9,005
Issuance of common stock upon exercise of warrants															Issuance of common stock upon exercise of warrants	832,460	1		3,016					—				3,017
Stock-based compensation	Stock-based compensation		—	—			146		—				146		Stock-based compensation	—	—		448					—				448

Net loss	Net loss		—	—			—		(4,425)				(4,425)		Net loss	—	—		—					(7,016)				(7,016)
Balance at June 30, 2020			6,717,900	$	1		$	113,497	$	(109,715)			$	3,783

			Six Months Ended June 30, 2020
		Common Stock		Additional Paid-In Capital			Accumulated Deficit				Total Stockholders' Equity
			Shares			Amount
Balance at December 31, 2019			5,080,100	$	1		$	107,239	$	(101,147)			$	6,093
Issuance of common stock and common stock warrants, net of issuance costs			1,189,000	—			5,963		—				5,963

Issuance of common stock upon exercise of pre-funded warrants			448,800	—			4		—				4

Stock-based compensation			—	—			291		—				291

Net loss			—	—			—		(8,568)				(8,568)
Balance at June 30, 2020			6,717,900	$	1		$	113,497	$	(109,715)			$	3,783
Balance at June 30, 2021															Balance at June 30, 2021	15,873,941	$	2	$	158,333				$	(124,920)			$	33,415

See accompanying notes to these unaudited consolidated financial statements.

Table of Contents

SELLAS LIFE SCIENCES GROUP, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Amounts in thousands)

(Unaudited)


		For the Six Months Ended June 30,					For the Six Months Ended June 30,
		2021		2020			2022		2021
Cash flows from operating activities:	Cash flows from operating activities:					Cash flows from operating activities:
Net loss	Net loss	$	(7,016)	$	(8,568)	Net loss	$	(25,158)	$	(7,016)
Adjustment to reconcile net loss to net cash used in operating activities:	Adjustment to reconcile net loss to net cash used in operating activities:					Adjustment to reconcile net loss to net cash used in operating activities:
Acquired in-process research and development expense						Acquired in-process research and development expense	10,000		—
Non-cash stock-based compensation						Non-cash stock-based compensation	825		448
Change in operating lease right of use assets						Change in operating lease right of use assets	127		—
Change in fair value of common stock warrants						Change in fair value of common stock warrants	(37)		59
Change in fair value of contingent consideration						Change in fair value of contingent consideration	(115)		263
Changes in operating assets and liabilities:						Changes in operating assets and liabilities:
Contract asset						Contract asset	—		1,128

Non-cash stock-based compensation		448		291

Change in operating lease right of use assets		0		24

Change in fair value of common stock warrants		59		(19)

Change in fair value of contingent consideration		263		281

Changes in operating assets and liabilities:

Contract asset		1,128		0
Prepaid expenses and other assets	Prepaid expenses and other assets	(1,932)		(1,383)		Prepaid expenses and other assets	19		(1,932)

Accounts payable	Accounts payable	(2,381)		(1,476)		Accounts payable	1,195		(2,381)
Accrued expenses and other current liabilities	Accrued expenses and other current liabilities	(136)		638		Accrued expenses and other current liabilities	366		(136)
Operating lease liabilities						Operating lease liabilities	(133)		—
Deferred revenue	Deferred revenue	(5,600)		0		Deferred revenue	—		(5,600)
Net cash used in operating activities						Net cash used in operating activities	(12,911)		(15,167)
Cash flows from investing activities:						Cash flows from investing activities:
Cash paid for acquisition of in-process research and development						Cash paid for acquisition of in-process research and development	(4,500)		—
Net cash used in investing activities						Net cash used in investing activities	(4,500)		—
Cash flows from financing activities:						Cash flows from financing activities:
Proceeds from issuance of common stock and common stock warrants, net of offering costs						Proceeds from issuance of common stock and common stock warrants, net of offering costs	22,996		6,765

Net cash used in operating activities		(15,167)		(10,212)

Cash flows from financing activities:

Proceeds from issuance of common stock, net of offering costs		6,765		5,963

Collection of stock subscription receivable		0		308
Proceeds from employee stock purchases						Proceeds from employee stock purchases	47		—
Net proceeds from exercise of warrants	Net proceeds from exercise of warrants	3,017		4		Net proceeds from exercise of warrants	—		3,017

Net cash provided by financing activities	Net cash provided by financing activities	9,782		6,275		Net cash provided by financing activities	23,043		9,782
Net decrease in cash, cash equivalents, restricted cash, and restricted cash equivalents		(5,385)		(3,937)
Net increase (decrease) in cash, cash equivalents, restricted cash, and restricted cash equivalents						Net increase (decrease) in cash, cash equivalents, restricted cash, and restricted cash equivalents	5,632		(5,385)
Cash, cash equivalents, restricted cash, and restricted cash equivalents at the beginning of period	Cash, cash equivalents, restricted cash, and restricted cash equivalents at the beginning of period	35,402		7,377		Cash, cash equivalents, restricted cash, and restricted cash equivalents at the beginning of period	21,455		35,402
Cash, cash equivalents, restricted cash, and restricted cash equivalents at the end of period	Cash, cash equivalents, restricted cash, and restricted cash equivalents at the end of period	$	30,017	$	3,440	Cash, cash equivalents, restricted cash, and restricted cash equivalents at the end of period	$	27,087	$	30,017

Supplemental disclosure of cash flow information:	Supplemental disclosure of cash flow information:					Supplemental disclosure of cash flow information:
Cash received during the period for interest	Cash received during the period for interest	$	4	$	25	Cash received during the period for interest	$	48	$	4

Supplemental disclosure of non-cash investing and financing activities:	Supplemental disclosure of non-cash investing and financing activities:					Supplemental disclosure of non-cash investing and financing activities:

Payable for acquired in-process research and development						Payable for acquired in-process research and development	$	5,500	$	—
Stock subscription receivable	Stock subscription receivable	$	2,240	$	0	Stock subscription receivable	$	—	$	2,240

Operating right of use asset and current and non-current lease liability		$	0	$	976

Offering expenses in accounts payable and accrued expenses and other current liabilities		$	0	$	25

Increase in operating right of use asset and current and non-current lease liability						Increase in operating right of use asset and current and non-current lease liability	$	449	$	—

See accompanying notes to these unaudited consolidated financial statements.

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SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. Description of Business

Overview

SELLAS Life Sciences Group, Inc. (the "Company" or "SELLAS") is a late-stage clinical biopharmaceutical company focused on novel ~~cancer immunotherapeutics~~therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, galinpepimut-S ("GPS"), is a cancer immunotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center ("MSK") and targets the Wilms Tumor 1 ("WT1") protein, which is present in ~~20 or more cancer~~an array of tumor types. ~~Based on its mechanism of action as a directly immunizing agent,~~ GPS has potential as a monotherapy or in combination with other immunotherapeutic agents to address a broad spectrum of hematologic, or blood, cancers and solid tumor indications. ~~SELLAS’~~SELLAS' second product candidate ~~nelipepimut-S~~is GFH009, a small molecule, highly selective cyclin-dependent kinase 9 ("~~NPS"~~CDK9") inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), ~~is a cancer immunotherapy targeting~~Inc., for all therapeutic and diagnostic uses in the ~~human epidermal growth factor receptor 2 ("HER2") expressing cancers with potential for the treatment~~world outside of patients with early stage breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, which includes triple negative breast cancer ("TNBC") patients, following standard of care.Greater China.

~~As used in this Quarterly Report on Form 10-Q,~~

2. Liquidity

On April 5, 2022, the ~~words~~Company closed an underwritten public offering (the "April 2022 Offering"), issuing 4,629,630 shares of common stock and accompanying common stock warrants to purchase an aggregate of 4,629,630 shares of common stock. The shares of common stock and accompanying common stock warrants were sold at a combined price of $5.40 per share and accompanying common stock warrant. Each common stock warrant sold with the ~~"Company," and "SELLAS" refer~~shares of common stock represents the right to ~~SELLAS Life Sciences Group, Inc. and its consolidated subsidiaries following the completion~~purchase 1 share of the ~~business combination with Galena Biopharma, Inc., a Delaware corporation ("Galena"),~~Company’s common stock at an exercise price of $5.40 per share. The common stock warrants are exercisable immediately and ~~SELLAS Life Sciences Group, Ltd., a privately held Bermuda exempted company ("Private SELLAS"), in December 2017. This business combination is referred~~will expire on April 5, 2027, five years from the date of issuance. The net proceeds to as the ~~Merger. Upon completion~~Company from the April 2022 Offering, after deducting the underwriting discounts and commissions and other offering expenses, and excluding the exercise of ~~the Merger, the Company's name changed from "Galena Biopharma, Inc." to "SELLAS Life Sciences Group, Inc." and the Company's financial statements became those of Private SELLAS.~~any warrants, were approximately $23.0 million.

On March ~~11, 2020,~~31, 2022, the ~~World Health Organization declared~~Company entered into an exclusive license agreement with GenFleet Therapeutics (Shanghai) Inc. ("GenFleet") pursuant to which GenFleet granted to the ~~outbreak~~Company a sublicensable, royalty-bearing license, under certain of its intellectual property, to develop, manufacture, and commercialize a ~~new coronavirus to be a “pandemic”~~small molecule CDK9 inhibitor for the treatment, diagnosis or prevention of disease in humans and animals in all countries and territories of the world other than mainland China, Hong Kong, Macau and Taiwan (the "GFH009 Territory"). The COVID-19 pandemic continues to present substantial public health and economic challenges around the world which have impacted, and will continue to impact, millions of individuals and business worldwide. Efforts to contain the spread of the coronavirus since March 2020 have led to travel bans and restrictions, quarantines, shelter-in-place orders and shutdowns. The CompanyCDK9 inhibitor, GFH009, is ~~continuously monitoring the impact of the pandemic on its~~currently in a Phase 1 clinical development programs. The full extent to which the COVID-19 pandemic directly or indirectly impacts the Company's business, results of operations and financial condition will depend on future developments that are highly uncertain, subject to change and cannot be predicted with confidence, including the actions taken to contain or treat COVID-19, the ultimate overall duration of the pandemic, the emergence of new variants of COVID-19, the emergence of new geographic hotspots where the coronavirus is spreading more rapidly, and continued or new travel restrictions, quarantines, social distancing and business closure requirementstrial in the United States and in other countries, as well as the effectiveness of actions taken globally to contain and treat the coronavirus, including the availability of safe and effective vaccines and the uptake thereof and whether existing vaccines are effective with respect to new variants. In particular, the continued spread of the coronavirus globally could adversely impact the Company's clinical trial operations and could have an adverse impact on our business and the financial results.China.

In consideration for the exclusive license, the Company agreed to pay GenFleet (i) an upfront and technology transfer fee of $10.0 million, of which $4.5 million was paid in April 2022 and $5.5 million is due upon the first day of the 15th calendar month following the effective date of the license agreement, (ii) development and regulatory milestone payments for up to three indications totaling up to $48.0 million in the aggregate, and (iii) sales milestone payments totaling up to $92.0 million in the aggregate upon the achievement of certain net sales thresholds in a given calendar year. The Company has also agreed to pay GenFleet single-digit tiered royalties based upon a percentage of annual net sales of GFH009 in the GFH009 Territory, with the royalty rate escalating based on the level of annual net sales ranging from the low to high single digits.

On March 31, 2022, the Company announced that an investigational new drug ("IND") application filed by 3D Medicines Inc. ("3DMed"), pursuant to its Exclusive License Agreement with the Company (the “3DMed License Agreement) for a small Phase 1 clinical trial investigating safety of GPS in China, was approved by China's National Medical Products Administration ("NMPA"). The IND approval by the NMPA triggered a $1.0 million milestone payment to the Company which was recognized as licensing revenue in the first quarter of 2022 and payment was received in May 2022. An additional $191.5 million in potential future development, regulatory, and sales milestones, not including future royalties, remains under the 3DMed License Agreement as of June 30, 2022, which milestones are variable in nature and not under the Company's control. The current clinical development plan provides for initiation of a Phase 2 clinical trial following receipt of satisfactory safety data from the Phase 1 clinical trial. In addition, the Company and 3DMed are planning a regulatory submission in China by the end of 2022 for the commencement of a Phase 1 or Phase 1/2 clinical trial of GPS in combination with envafolimab, 3DMed's checkpoint inhibitor which has been approved in China and is the first single-domain PD-L1 targeting antibody

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SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

~~2. Liquidity~~

~~Since inception,~~administered by rapid subcutaneous injection. Under the ~~Company has incurred recurring losses and negative cash flows from operations and, as~~terms of ~~June 30, 2021, has an accumulated deficit~~the 3DMed License Agreement, the initiation of ~~$124.9 million. During the six months ended June 30, 2021, the Company used $15.2 million of cash in operations which included~~ a ~~net loss of $7.0 million, a $1.9 million increase in prepaid expenses and other assets primarily for insurance and prepaid~~Phase 2 clinical trial ~~costs,~~will trigger a ~~$5.6 million decrease in deferred revenue due~~milestone payment to the recognition of licensing revenues and a $2.5 million decrease in accounts payable and accrued expenses and other current liabilities, partially offset by a $1.1 million decrease of contract acquisition costs related to the out-licensing of intellectual property rights and transfer of technical know-how and various net non-cash charges of $0.7 million. The Company expects to continue to generate operating losses and negative cash flows for the next few years and will need additional funding to support its planned operating activities through profitability. The transition to profitability is dependent upon the successful development, approval, and commercialization of the Company's product candidates and the achievement of a level of revenues adequate to support its cost structure.Company.

On April 16, 2021, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. (the "Agent"). From time to time during the term of the Sales Agreement, the Company may offer and sell shares of common stock having an aggregate offering price up to a total of $50.0 million in gross proceeds. The Agent will collect a fee equal to 3% of the gross sales price of all shares of common stock sold. Shares of common stock sold under the Sales Agreement ~~will be~~are offered and sold pursuant to the Company's registration statement on Form S-3, which was filed with the SEC on April 16, 2021 and ~~was~~ declared effective on April 29, 2021. During the ~~three months~~year ended ~~June 30,~~December 31, 2021, the Company sold a total of 786,927 shares of common stock pursuant to the Sales Agreement at an average price of $12.04 per share for aggregate net proceeds of approximately $9.0 ~~million, of which approximately $2.2 million in net proceeds were received in July 2021 and classified as a stock subscription receivable as of~~million. During the six months ended June 30, ~~2021.~~2022, the Company sold an additional 16,289 shares of common stock pursuant to the Sales Agreement at an average price of $3.16 per share for aggregate gross proceeds of approximately $0.1 million. There remains approximately $40.5 million available for future sales of shares of common stock under the Sales Agreement. Other than the Sales Agreement, the Company currently does not have any commitments to obtain additional funds.

~~The~~Since inception, the Company ~~received $1.0 million~~has incurred recurring losses and ~~$2.0 million during~~negative cash flows from operations and, as of June 30, 2022, has an accumulated deficit of $163.8 million. During the ~~three and~~ six months ended June 30, ~~2021, respectively,~~2022, the Company incurred a net loss of $25.2 million, which includes a one-time $10.0 million expense for acquired in-process research and development related to the upfront license fee for GFH009, and used $12.9 million of cash in operations. The Company expects to generate losses from operations for the ~~achievement of certain~~foreseeable future primarily due to research and development ~~milestones pursuant to~~costs for its product candidates, which raises substantial doubt about the Company's Exclusive License Agreement (the "3DMed License Agreement) with 3D Medicines, Inc. ("3DMed"). An additional $192.5 million in potential future certain development, regulatory, and sales milestones remains under the 3DMed License Agreement, which milestones are variable in nature and not under the Company's control.ability to continue as a going concern.

As of June 30, ~~2021,~~2022, the Company had cash and cash equivalents of approximately ~~$29.9~~$27.0 million and restricted cash and cash equivalents of $0.1 ~~million, and $2.2 million of stock subscription receivable which cash was received in July 2021.~~million. In accordance with Accounting Standards Codification ("ASC") 205-40, Presentation of Financial Statements - Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the consolidated financial statements are issued. The Company expects its cash and cash equivalents ~~together with access to the Sales Agreement to sell common stock,~~ will not be sufficient to fund its current planned operations for at least the next 12twelve months from the date of issuance of these financial statements. The Company has prepared its consolidated financial statements ~~though~~assuming that it may pursue additional capital resources through public or private equity or debt financings or by entering into additional license agreements or collaborations with other companies. Management's expectations with respect to its ability to fund current planned operations is based on estimates that are subject to riskswill continue as a going concern, which contemplates the realization of assets and ~~uncertainties. If actual results are different from management's estimates,~~ the ~~Company may need to seek additional strategic or financing opportunities sooner than would otherwise be expected. There is no guarantee that any~~satisfaction of ~~these strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders. If~~liabilities in the ~~Company is unable to obtain additional funding on a timely basis, it may be forced to significantly curtail, delay, or discontinue one or more~~normal course of its planned research and development programs or be unable to expand its operations or otherwise prepare for the potential regulatory approval and commercialization of its product candidates, assuming positive data.business.

The Company will require substantial additional financing to commercially develop any current or future product candidates. Alternatively, the Company will be required to scale back its plans and place certain activities on hold. Other than the Sales Agreement, the Company currently does not have any commitments to obtain additional funds, and may be unable to obtain sufficient funding in the future on acceptable terms, if at all. The Company's management continues to evaluate different strategies to obtain the required funding for future operations. These strategies may include utilizing the Sales Agreement, public and private placements of equity and/or debt securities, payments from potential strategic research and development collaborations, and licensing and/or marketing arrangements with pharmaceutical companies. Additionally, the Company may continue to pursue discussions with global and regional pharmaceutical companies for licensing and/or co-development rights to its product candidates.

~~Table of Contents~~

~~SELLAS LIFE SCIENCES GROUP, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued~~

~~(Unaudited)~~

3. Basis of Presentation and Significant Accounting Policies

The Company's complete summary of significant accounting policies can be found in "Item 8. Financial Statements and Supplementary Data - Note 3. Basis of Presentation and Significant Accounting Policies" in the audited annual consolidated financial statements included in the ~~2020~~2021 Annual Report. The significant accounting policies summarized and included in the ~~2020~~2021 Annual Report have not materially changed, except as set forth below.

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SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

Basis of Presentation

The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the ~~Accounting Standards Codification ("ASC")~~ASC and Accounting Standards Updates ("ASUs") of the Financial Accounting Standards Board ("FASB").

Principles of Consolidation

The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated upon consolidation. Unless the context otherwise indicates, reference in these notes to the "Company" refer to SELLAS Life Sciences Group, Inc., and its wholly owned subsidiaries, ~~Private~~ SELLAS Life Sciences Group, Ltd., a privately held Bermuda exempted company, SLSG Limited, LLC, Sellas Life Sciences Limited, and Apthera, Inc. ~~The functional currency of the Company's non-U.S. operations is the U.S. dollar.~~

Unaudited Interim Results

These consolidated financial statements and accompanying notes should be read in conjunction with the Company's annual consolidated financial statements and the notes thereto included in the ~~2020~~2021 Annual Report. The accompanying consolidated financial statements as of June 30, ~~2021~~2022 and for the three and six months ended June 30, ~~2021~~2022 and ~~2020,~~2021, are unaudited, but include all adjustments, consisting of normal recurring entries, that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, ~~2020~~2021 have been derived from the audited financial statements as of that date.

~~Reclassification~~Impact of COVID-19

~~Certain prior year amounts have been reclassified~~The ongoing global COVID-19 pandemic, including the surges of cases from various variants, continues to ~~conform~~disrupt the Company’s business operations and those of its collaborators, including 3DMed and GenFleet, contractors, contract research organizations (“CROs”), suppliers, clinical sites, contract manufacturing organizations (“CMOs”), and other partners. The COVID-19 pandemic has and may continue to ~~current year presentation. These reclassifications had no effect~~affect the health and availability of the Company’s workforce and that of the third-parties it relies on, such as its CROs, clinical sites, CMOs, and other contractors as well as the ~~Company's loss from~~governmental agencies, such as the U.S. Food and Drug Administration (“FDA”) and health authorities in other countries which could delay or otherwise adversely impact the ability of such parties to fulfill their obligations. The Company is continuously monitoring the impact of the pandemic on its clinical development programs. The full extent to which the COVID-19 pandemic will continue to directly or indirectly impact the Company’s business, results of operations ~~net loss,~~ and ~~net loss per share.~~financial condition will depend on future developments that are highly uncertain, subject to change and cannot be predicted with confidence, including the duration of the outbreak, the continued availability and efficacy of vaccines and booster shots, new information which may emerge concerning the severity of COVID-19, the emergence of new variants of COVID-19, the actions to contain COVID-19 or treat its impact, including continuing or new lockdowns, among others, and the direct and indirect economic effects of the pandemic, including as a result of inflation, supply chain disruptions and labor shortages.

~~Stock Subscription Receivable~~Acquired In-Process Research and Development

~~In accordance with FASB ASC 505-10-45-2,~~ ~~Receivables for Issuance of Equity~~,Costs incurred in obtaining technology licenses are immediately recognized as acquired in-process research and development expense, provided the ~~Company recorded a stock subscription receivable as of June 30, 2021~~technology licensed has no alternative future use. Payments related to contingent consideration such as development milestones, commercial milestones and royalties (Note 5) will be recognized when the ~~sale, prior to June 30, 2021~~contingency is probable and before the financial statements are issued or available to be issued, of 157,130 shares of common stock pursuant to the Sales Agreement for net proceeds of $2.2 million which cash was collected on July 2, 2021.reasonably estimable as prescribed by ASC 450, Contingencies.

~~Time-Vested Restricted Stock Units~~

During the six months ended June 30, 2021, the Board of Directors granted restricted stock units ("RSUs") to employees that vest based on continuous service. Time-vested RSUs awarded to employees vest one-fourth per year annually over four years, provided the employee remains employed with the Company. The fair values of the RSUs are measured on the date of grant and are based on the Company's closing stock price on such date. Compensation expense for RSUs with only service conditions is recognized straight-line over the applicable service period. The Company accounts for forfeitures of RSUs when they occur. Previously recognized compensation expense for forfeited RSUs are reversed in the period the RSUs are forfeited.

~~Table of Contents~~

~~SELLAS LIFE SCIENCES GROUP, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued~~

~~(Unaudited)~~

Net Loss Per Share

Net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, stock options and unvested

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SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

restricted stock that would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share, the weighted average number of shares remains the same for both calculations due to the fact that, when a net loss exists, dilutive shares are not included in the calculation as the impact is anti-dilutive.

The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive (in thousands):

Six Months Ended June 30,
2021 2020
Common stock warrants 559 1,120
Stock options 520 208
RSUs 210 170
1,289 1,498

~~Recent Accounting Standards Adopted and Recent Accounting Standards Not Yet Adopted~~


	Six Months Ended June 30,
	2022	2021
Common stock warrants	5,148	559
Stock options	1,012	520
Restricted stock units ("RSUs")	297	210
	6,457	1,289

Recent Accounting Standards Adopted

In ~~December 2019,~~May 2021, the FASB issued ASU ~~2019-12,~~No. 2021-04, ~~Income Taxes (Topic 740): Simplifying the~~Issuer’s Accounting for ~~Income Taxes~~Certain Modifications of Exchanges of Freestanding Equity-Classified Written Call Options which, among other things, eliminates certain exceptions in the current rules regarding the approach for intraperiod tax allocations and the methodology for calculating income taxes in an interim period, and clarifiesto clarify the accounting for ~~transactions~~modifications or exchanges of freestanding equity-classified written call options, such as warrants, that ~~result in a step-up in the tax basis of goodwill. The standard was adopted by~~remain equity classified after modification or exchange. This ASU became effective for the Company on January 1, ~~2021. This new standard~~2022 and did not have a material impact on the ~~Company’s~~Company's consolidated financial statements.

Recent ~~accounting standards not yet adopted~~Accounting Standards Not Yet Adopted

In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity which, among other things, simplifies the accounting models for the allocation of proceeds attributable to the issuance of a convertible debt instrument. As a result, after adopting the ASU’s guidance, entities will not separately present in equity an embedded conversion feature in such debt. Instead, they will account for a convertible debt instrument wholly as debt, and for convertible preferred stock wholly as preferred stock (i.e., as a single unit of account), unless (i) a convertible instrument contains features that require bifurcation as a derivative under ASC 815 or (ii) a convertible debt instrument was issued at a substantial premium. The standard becomes effective for the Company in the first quarter of ~~2022~~2024 and early adoption is permitted. The Company is currently evaluating the potential impact of the adoption of this standard on its consolidated financial statements.

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SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

4. Fair Value Measurements

The following tables present information about the Company's assets and liabilities measured at fair value on a recurring basis in the consolidated balance sheets (in thousands):

~~Table of Contents~~


Description	June 30, 2022		Quoted Prices In Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Unobservable Inputs (Level 3)
Assets:
Cash equivalents	$	25,984	$	25,984	$	—	$	—
Restricted cash equivalents	100		100		—		—
Total assets measured and recorded at fair value	$	26,084	$	26,084	$	—	$	—
Liabilities:
Warrant liability	$	3	$	—	$	—	$	3
Contingent consideration	181		—		—		181
Total liabilities measured and recorded at fair value	$	184	$	—	$	—	$	184

~~SELLAS LIFE SCIENCES GROUP, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued~~

~~(Unaudited)~~

Description June 30, 2021 Quoted Prices In
Active Markets
(Level 1) Significant Other
Observable
Inputs (Level 2) Unobservable
Inputs
(Level 3)
Assets:
Cash equivalents $ 29,455 $ 29,455 $ 0 $ 0
Restricted cash equivalents 100 100 0 0
Total assets measured and recorded at fair value $ 29,555 $ 29,555 $ 0 $ 0
Liabilities:
Warrant liability $ 114 $ 0 $ 0 $ 114
Contingent consideration 4,896 0 0 4,896
Total liabilities measured and recorded at fair value $ 5,010 $ 0 $ 0 $ 5,010


Description	Description	December 31, 2020		Quoted Prices In Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Unobservable Inputs (Level 3)		Description	December 31, 2021		Quoted Prices In Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Unobservable Inputs (Level 3)
Assets:	Assets:									Assets:
Cash equivalents	Cash equivalents	$	34,959	$	34,959	$	0	$	0	Cash equivalents	$	21,000	$	21,000	$	—	$	—
Restricted cash equivalents	Restricted cash equivalents	100		100		0		0		Restricted cash equivalents	100		100		—		—
Total assets measured and recorded at fair value	Total assets measured and recorded at fair value	$	35,059	$	35,059	$	0	$	0	Total assets measured and recorded at fair value	$	21,100	$	21,100	$	—	$	—
Liabilities:	Liabilities:									Liabilities:
Warrant liability	Warrant liability	$	55	$	0	$	0	$	55	Warrant liability	$	40	$	—	$	—	$	40
Contingent consideration	Contingent consideration	4,633		0		0		4,633		Contingent consideration	296		—		—		296
Total liabilities measured and recorded at fair value	Total liabilities measured and recorded at fair value	$	4,688	$	0	$	0	$	4,688	Total liabilities measured and recorded at fair value	$	336	$	—	$	—	$	336

The Company did not transfer any financial instruments into or out of Level 3 classification, during the six months ended June 30, ~~2021~~2022 or during the year ended December 31, ~~2020.~~2021. See Note 8,9, Warrants to Acquire Shares of Common Stock, for a reconciliation of the changes in the fair value of the warrant liability for the six months ended June 30, ~~2021.~~2022.

A reconciliation of the change in the fair value of the contingent consideration liability for the six months ended June 30, ~~2021~~2022 is as follows (in thousands):


	Fair Value Measurements Using Significant Unobservable Inputs (Level 3)
Contingent consideration, December 31, ~~2020~~2021	$	~~4,633~~296
Change in the estimated fair value of the contingent consideration	~~263~~ (115)
Contingent consideration, June 30, ~~2021~~2022	$	~~4,896~~181

~~The fair value~~

Table of ~~the contingent consideration is measured at the end of each reporting period using Level 3 inputs in a probability-weighted, discounted cash-outflow model.~~ Contents

SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

The contingent consideration relates to ~~Galena's acquisition of Apthera, Inc. in 2011 and~~ the future contingent payments of up to $32.0 million based on the achievement of certain development and commercial milestones relating to the Company’s ~~NPS~~nelipepimut-S ("NPS") product candidate, of which $2.0 million has been paid to date. The remaining contingent consideration of up to $30.0 million is payable at the election of the Company in either cash or shares of common stock, provided that the Company may not issue any shares in satisfaction of any contingent consideration, unless it has first obtained approval from its stockholders in accordance with Rule 5635(a) of the Nasdaq Marketplace Rules.

~~Table~~ The fair value of ~~Contents~~

~~SELLAS LIFE SCIENCES GROUP, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued~~

~~(Unaudited)~~

the contingent consideration is measured at the end of each reporting period using Level 3 inputs. The fair value of development and regulatory milestones are estimated utilizing a probability adjusted, discounted cash flow approach and the fair value of net sales milestones is estimated utilizing an option pricing model with Monte Carlo simulation.

The following significant unobservable ~~assumptions include~~inputs were used in the probability of achieving each milestone, the date the Company expects to reach the milestone, and a determination of present value factors used to discount future expected cash outflows. Changes in fair value reflect new information about the probability and anticipated timing of meeting the conditionsvaluation of the ~~milestone payments. In the absence of new information, changes in fair value will only reflect the interest component of~~ contingent consideration related to the passage of time. As of June 30, 2021, estimated future contingent milestone payments related to the Company's business range from 0, if no milestone events are achieved, to a maximum of $30.0 million if all development and commercial milestones are reached. As of June 30, 2021, resulting probability-weighted cash flows were discounted using a weighted average cost of capital of 11.8% for development milestones and cost of debt of 5.4% for the commercial milestones. The Company estimates the timing of achievement of these development milestones to range from liability:

~~five~~
~~to eight years as of June 30, 2021.~~


	As of June 30, 2022		As of December 31, 2021
Potential milestone payments	$0 - $30 million		$0 - $30 million
Discount rate	16.5	%	15.5	%
Cumulative probability of success	5.3	%	5.3	%
Projected years of payments	2028 - 2031		2028 - 2031

5. ~~Balance Sheet Accounts~~Acquired In-Process Research and Development

~~Prepaid expenses and other current assets consist of the following (in thousands):~~

June 30, 2021 December 31, 2020
Insurance $ 1,247 $ 221
Clinical trial costs 996 95
Professional fees 72 49
Other 3 30
Prepaid expenses and other current assets $ 2,318 $ 395
Exclusive License Agreement with GenFleet Therapeutics (Shanghai) Inc.

On March 31, 2022, the Company entered into an exclusive license agreement with GenFleet pursuant to which GenFleet granted to the Company a sublicensable, royalty-bearing license, under certain of its intellectual property, to develop, manufacture, and commercialize GFH009 for the treatment, diagnosis or prevention of disease in humans and animals in the GFH009 Territory. GFH009 is currently in a Phase 1 clinical trial in the United States and China.

~~Accrued expenses~~In consideration for the exclusive license, the Company has agreed to pay to GenFleet (i) an upfront and ~~other current liabilities consist~~technology transfer fee of $10.0 million, of which $4.5 million was paid in April 2022 and $5.5 million is due upon the first day of the 15th calendar month following ~~(in thousands):~~the effective date of the license agreement, (ii) development and regulatory milestone payments for up to three indications totaling up to $48.0 million in the aggregate, and (iii) sales milestone payments totaling up to $92.0 million in the aggregate upon the achievement of certain net sales thresholds in a given calendar year. The Company has also agreed to pay GenFleet single-digit tiered royalties based upon a percentage of annual net sales of GFH009 in the GFH009 Territory, with the royalty rate escalating based on the level of annual net sales ranging from the low to high single digits.

June 30, 2021 December 31, 2020
Clinical trial costs $ 806 $ 631
Compensation and related benefits 576 812
Professional fees 149 276
Other 250 194
Accrued expenses and other current liabilities $ 1,781 $ 1,913

During the six months ended June 30, 2022, the Company expensed $10.0 million related to the acquired technology as in-process research and development based on the assessment that the technology has no alternative future use, $4.5 million of which was paid in April 2022 and the remaining $5.5 million expected to be paid by the end of the second quarter of 2023 for which the Company has recorded a current payable as of June 30, 2022.

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SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

6. Balance Sheet Accounts

Prepaid expenses and other current assets consist of the following (in thousands):


	June 30, 2022		December 31, 2021
Insurance	$	1,206	$	217
Clinical development	240		1,309
Professional fees	111		36
Other	93		27
Prepaid expenses and other current assets	$	1,650	$	1,589

Accrued expenses and other current liabilities consist of the following (in thousands):


	June 30, 2022		December 31, 2021
Clinical trial costs	$	1,815	$	1,325
Compensation and related benefits	869		989
Professional fees	30		165
Other	292		161
Accrued expenses and other current liabilities	$	3,006	$	2,640

7. Commitments and Contingencies

~~Lease~~Leases

The Company has a non-cancelable operating lease for certain executive, administrative, and general business office space for its headquarters in New York, New York, which began on June 5, 2020, was amended in February 2022 to add additional space, and has a term through December 31, 2024. The Company assessed the lease amendment for the additional space and determined it should be accounted for as a separate contract.

The weighted average discount rate of the Company's operating ~~lease~~leases under FASB Topic ASC ~~842:~~ 842,Leases is ~~the Company's estimated incremental borrowing rate of 13%~~approximately 13.95%. As of June 30, ~~2021,~~2022, the ~~lease has~~leases have a remaining term of ~~3.5~~2.50 years.

Rent expense related to the Company's operating ~~lease~~leases was approximately $0.1 million ~~for~~ for each of the three months ended June 30, 2022 and 2021, and ~~2020~~$0.2 million and $0.1 million ~~and $0.2 million~~ forfor the six months ended June 30, ~~2021~~2022 and ~~2020,~~2021, respectively. The Company made cash payments related to its operating ~~lease~~leases of approximately $0.1 million for each of the three months ended June 30, ~~2021~~2022 and ~~2020~~2021 and $0.2 million for each of the six months ended June 30, ~~2021~~2022 and ~~2020.~~ 2021.

Future minimum lease payments ~~under the Company's non-cancelable operating lease~~ are as follows as of June 30, ~~2021~~2022 (in thousands):


Future minimum lease payments:	Future minimum lease payments:			Future minimum lease payments:
2021 (remaining)		$	152
2022		311
2022 (remaining)				2022 (remaining)	$	253
2023	2023	321		2023	518
2024	2024	330		2024	533
Total future minimum lease payments	Total future minimum lease payments	1,114		Total future minimum lease payments	1,304
Less: imputed interest	Less: imputed interest	(211)		Less: imputed interest	(180)
Current and non-current operating lease liability		$	903
Current and non-current operating lease liabilities				Current and non-current operating lease liabilities	$	1,124

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SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

Legal Proceedings

From time to time, the Company is subject to various pending or threatened legal actions and proceedings, including those that arise in the ordinary course of its business, which may include employment matters, breach of contract disputes and stockholder litigation. Such actions and proceedings are subject to many uncertainties and to outcomes that are not predictable with assurance and that may not be known for extended periods of time. The Company records a liability in its consolidated financial statements for costs related to claims, including future legal costs, settlements and judgments, when the Company has assessed that a loss is probable and an amount can be reasonably estimated. If the reasonable estimate of a probable loss is a range, the Company records the most probable estimate of the loss or the minimum amount when no amount within the range is a better estimate than any other amount. The Company discloses a contingent liability even if the liability is not probable or the amount is not estimable, or both, if there is a reasonable possibility that a material loss may have been incurred. In the opinion of management, as of the date ~~hereof,~~of filing of these unaudited interim consolidated financial statements as of and for the period ended June 30, 2022, the amount of liability, if any, with respect to these matters, individually or in the aggregate, will not materially affect the Company’s consolidated results of operations, financial position or cash flows.

~~The Company’s predecessor company, Galena,~~ As of June 30, 2022 there was involved in multiple legal proceedings and administrative actions, including stockholder class actions, both state and federal. The remaining legal proceedings to which the Company is now subject are as follows:

~~Table of Contents~~

~~SELLAS LIFE SCIENCES GROUP, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued~~

~~(Unaudited)~~

On February 13, 2017, certain putative shareholder securities class action complaints were filed in federal court alleging, among other things, that Galena and certain of Galena's former officers and directors failed to disclose that Galena’s promotional practices for Abstral® (fentanyl sublingual tablets) were allegedly improper and that Galena may be subject to civil and criminal liability, and that these alleged failures rendered Galena’s statements about its business misleading. The actions were consolidated, lead plaintiffs were named by the U.S. District Court for the District of New Jersey and a consolidated complaint was filed. The Company filed a motion to dismiss the consolidated complaint. On August 21, 2018, the Company's motion to dismiss the consolidated complaint was granted without prejudice to file an amended complaint. On September 20, 2018, the plaintiffs filed an amended complaint. On October 22, 2018, the Company filed a motion to dismiss the amended complaint. On November 13, 2019, the U.S. District Court for the District of New Jersey granted the Company's motion to dismiss without prejudice to file an amended complaint. On December 20, 2019, the lead plaintiffs filed a second Amended Consolidated Class Action Complaint. On January 29, 2020, the Company filed a motion to dismiss the amended complaint. On January 5, 2021, the U.S. District Court for the District of New Jersey granted the Company's motion to dismiss without prejudice to file an amended complaint. On February 18, 2021, the lead plaintiffs filed a third Amended Consolidated Class Action Complaint. The Company has reached a settlement in principle with the plaintiffs in this action which is subject to final documentation and court approval and which will be fully covered by the Company's directors and officers insurance policy applicable to this case.

In March 2017, a derivative complaint was filed in the U.S. District Court for the District of New Jersey against the Company’s former directors and Galena, as a nominal defendant. In July 2017, a derivative complaint was filed in California state court against the Company’s former directors and Galena, as a nominal defendant. In January 2018, a derivative complaint was filed in the U.S. District Court for the District of New Jersey against the Company’s former directors, officers and employees, and the Company as a nominal defendant. These complaints purport to assert derivative claims for breach of fiduciary duty on the Company’s behalf against the Company’s former directors and, in certain of the complaints, the Company’s current directors, and the Company’s former officers and former employees, based on substantially similar facts as alleged in the putative shareholder securities class action complaints mentioned above. The derivative lawsuit filed in California state court is currently stayedno pending resolution of a motion to dismiss in the referenced securities class action. On July 13, 2020 and July 16, 2020, respectively, the Company filed motions to dismiss the 2 complaints filed in the U.S. District Court for the District of New Jersey. The Company has reached a settlement in principle with the plaintiffs in these three cases which is subject to final documentation and court approval and which will be fully covered by the Company's directors and officers insurance policy applicable to these cases.or threatened litigation.

~~Table of Contents~~

~~SELLAS LIFE SCIENCES GROUP, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued~~

~~(Unaudited)~~

7.8. Stockholders’ Equity

Preferred Stock

The Company has authorized up to 5,000,000 shares of preferred stock, $0.0001 par value per share, for issuance. There were no preferred shares outstanding as of June 30, 2022 and December 31, 2021.

Common Stock

The Company has authorized up to 350,000,000 shares of common stock, $0.0001 par value per share, for issuance.

As of June 30, ~~2021,~~2022, the Company has shares of common stock reserved for future issuance as follows (in thousands):


Warrants outstanding			~~559~~5,148

Stock options outstanding			~~520~~1,012
RSUs outstanding			~~210~~297
Shares reserved for future issuance under the Company’s 2019 Equity Incentive Plan			~~463~~666
Shares reserved for future issuance under the 2021 Employee Stock Purchase Plan			~~300~~290
~~Shares reserved for future issuance under the 2017 Employee Stock Purchase Plan~~			11

Total common stock reserved for future issuance			~~2,063~~7,413

Table of Contents

SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

9. Warrants to Acquire Shares of Common Stock

Warrants Outstanding

The following is a summary of the activity of the Company's warrants to acquire shares of common stock for the six months ended June 30, ~~2021~~2022 (in thousands):


Warrant Issuance	Warrant Issuance	Outstanding, December 31, 2020	Granted	Exercised	Canceled/Expired	Outstanding, June 30, 2021	Expiration	Warrant Issuance	Outstanding, December 31, 2021	Granted	Canceled/Expired	Outstanding, June 30, 2022	Exercise Price per Share		Expiration
Warrants classified as equity:								Warrants classified as equity:
April 2022 Offering								April 2022 Offering	—	4,630	—	4,630	$	5.40	April 2027
January 2020 Offering								January 2020 Offering	309	—	—	309	$	3.93	July 2025
July 2020 PIPE Offering	July 2020 PIPE Offering	445	0	(420)	0	25	August 2025	July 2020 PIPE Offering	25	—	—	25	$	3.30	August 2025
January 2020 Offering		719	0	(410)	0	309	July 2025

June 2019 Offering		2	0	(1)	0	1	June 2024

July 2018 Offering								July 2018 Offering	132	—	—	132	$	7.50	July 2023
March 2019 Exercise Agreement	March 2019 Exercise Agreement	63	0	0	0	63	March 2024	March 2019 Exercise Agreement	30	—	—	30	$	7.50	March 2024
July 2018 Offering		141	0	(1)	0	140	July 2023

Other	Other	22	0	0	(1)	21	November 2021 - November 2023	Other	9	—	—	9	$	306.66	December 2022 - June 2024
									505	4,630	—	5,135
Warrants classified as liability								Warrants classified as liability	14	—	(1)	13	$	7.50	September 2023 - November 2023
									519	4,630	(1)	5,148

		1,392	0	(832)	(1)	559

Warrants to acquire shares of common stock primarily consist of equity-classified warrants. In addition, warrants to acquire shares of common stock that may ~~be settled~~require the Company to settle in cash ~~which~~ are liability-classified ~~warrants, and equity-classified~~ warrants.

Warrants Classified as Equity

~~Table~~The warrants to acquire shares of ~~Contents~~common stock issued during the April 2022 Offering were recorded as equity upon issuance. During its evaluation of equity classification of these warrants, the Company considered the conditions as prescribed within ASC 815-40, Derivatives and Hedging, Contracts in an Entity’s own Equity (“ASC 815-40”). The conditions within ASC 815-40 are not subject to a probability assessment. The warrants to acquire shares of common stock do not fall under the liability criteria within ASC 480, Distinguishing Liabilities from Equity, as they are not puttable and do not represent an instrument that has a redeemable underlying security. The warrants do meet the definition of a derivative instrument under ASC 815, but are eligible for the scope exception as they are indexed to the Company’s own stock and would be classified in permanent equity if freestanding.

~~SELLAS LIFE SCIENCES GROUP, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued~~

~~(Unaudited)~~

Warrants Classified as Liabilities

Liability-classified warrants consist of warrants to acquire common stock issued in connection with certain previous equity financings. These warrants may be settled in cash and were determined not to be indexed to the Company’s common stock.

The estimated fair value of outstanding warrants accounted for as liabilities is determined at each balance sheet date. Any decrease or increase in the estimated fair value of the warrant liability since the most recent balance sheet date is recorded in the consolidated statement of operations as change in fair value of warrant liability. The fair value of the warrants is estimated using a Black-Scholes pricing model with the following inputs:

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SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

As of June 30, 2021
Warrant Issuance Outstanding (in thousands) Strike price (per share) Expected term (years) Volatility % Risk-free rate %
Other warrants (liability-classified) 13 $ 7.50 2.26 151.45 % 0.30 %
As of December 31, 2020
Warrant Issuance Outstanding (in thousands) Strike price (per share) Expected term (years) Volatility % Risk-free rate %
Other warrants (liability-classified) 13 $ 7.50 2.75 150.38 % 0.16 %


	June 30, 2022			December 31, 2021
Risk free interest rate	2.83		%	0.65		%
Volatility	90.76		%	131.04		%
Expected term (years)	1.26			1.75
Expected dividend yield	—		%	—		%
Strike price	$	7.50		$	7.50

The expected volatility assumptions are based on the Company's implied volatility in combination with the implied volatilities of similar publicly traded entities. The expected life assumption is based on the remaining contractual terms of the warrants. The risk-free rate is based on the 0zero coupon rates in effect at the time of valuation. The dividend yield used in the pricing model is 0,zero, because the Company has no present intention to pay cash dividends.

The changes in fair value of the warrant liability for the six months ended June 30, ~~2021~~2022 were as follows (in thousands):

Warrant Issuance Warrant liability, December 31, 2020 Change in fair value of warrants Warrant liability, June 30, 2021
Other warrants (liability-classified) $ 55 $ 59 $ 114
$ 55 $ 59 $ 114


Warrant liability, December 31, 2021	$	40


Change in fair value of warrants	(37)
Warrant liability, June 30, 2022	$	3

~~Table of Contents~~

~~SELLAS LIFE SCIENCES GROUP, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued~~

~~(Unaudited)~~

9.10. License Revenue ~~with 3D Medicines, Inc.~~

Exclusive License Agreement with 3D Medicines Inc.

In December 2020, the Company, together with its wholly-owned subsidiary, SLSG Limited, LLC, entered into an Exclusive License Agreement (the “3DMed License Agreement”) with 3D Medicines Inc. ("3DMed"), pursuant to which the Company granted 3DMed a sublicensable, royalty-bearing license, under certain intellectual property owned or controlled by the Company, to develop, manufacture and have manufactured, and commercialize GPS and heptavalent GPS (referred to as GPS Plus) product candidates ("GPS Licensed Products") for all therapeutic and other diagnostic uses in mainland China, Hong Kong, Macau and Taiwan ("3DMed Territory"). The license is exclusive, except with respect to certain know-how that has been non-exclusively licensed to the Company and is sublicensed to 3DMed on a non-exclusive basis. The Company has retained development, manufacturing and commercialization rights with respect to the GPS Licensed Products in the rest of the world.

In partial consideration for the rights granted by the Company, 3DMed agreed to pay the Company (i) a one-time upfront cash payment of $7.5 million, and (ii) milestone payments totaling up to $194.5 million in the aggregate upon the achievement of certain technology transfer, development and regulatory milestones, as well as sales milestones based on certain net sales thresholds of GPS Licensed Products in the 3DMed Territory in a given calendar year. ~~The Company is responsible for providing the licensed technology and data (the "3DMed License") as well as transferring certain technological and manufacturing know-how (the "transfer of know-how").~~

3DMed also agreed to pay tiered royalties based upon a percentage of annual net sales of GPS Licensed Products in the 3DMed Territory ranging from the high single digits to the low double digits. The royalties are payable on a GPS Licensed Product-by-GPS Licensed Product and region-by-region basis commencing on the first commercial sale of a GPS Licensed Product in a region and continuing until the latest of (i) the date that is 15 years from the receipt of marketing authorization for such GPS Licensed Product in such region and (ii) the date that is 10 years from the expiration of the last valid claim of a licensed patent covering or claiming such GPS Licensed Product in such region. The royalty rate is subject to reduction under certain circumstances, including when generic competition for a GPS Licensed Product exists in a particular region.

3DMed is responsible for all costs related to developing, obtaining regulatory approval of and commercializing the GPS Licensed Products in the 3DMed Territory. 3DMed is required to use commercially reasonable best efforts to develop and obtain regulatory approval for, and upon receipt of regulatory approval, commercialize the GPS Licensed Products in the 3DMed Territory. A joint steering committee has been established between 3DMed and the Company to coordinate and review the development, manufacturing and commercialization plans with respect to the GPS Licensed Products in the 3DMed Territory. The Company and 3DMed also agreed to negotiate in good faith the terms and conditions of a clinical supply agreement, a commercial supply agreement, and related quality agreements pursuant to which the Company will manufacture or have manufactured and supply 3DMed with all quantities of the GPS Licensed Products necessary for 3DMed to develop and commercialize the GPS Licensed Products in the 3DMed Territory until 3DMed has received all approvals required for 3DMed or its designated contract manufacturing organization to manufacture the GPS Licensed Products in the 3DMed Territory.

The 3DMed License Agreement will expire on a GPS Licensed Product-by-GPS Licensed Product and region-by-region basis on the date of the expiration of all of 3DMed’s payment obligations to the Company. Upon expiration of the 3DMed License Agreement, the license granted to 3DMed will become fully paid-up, perpetual and irrevocable. Either party may terminate the 3DMed License Agreement for the other party’s material breach following a cure period or upon certain insolvency events. The Company may terminate the 3DMed License Agreement if 3DMed or its affiliates or sublicensees challenge the validity or enforceability of the licensed patents. At any time following the two-year anniversary of the effective date, 3DMed has the right to terminate the 3DMed License Agreement for convenience, subject to certain requirements. 3DMed may terminate the 3DMed License Agreement upon prior notice to the Company if the grant of the license to 3DMed is prohibited or delayed for a period of time due to a change of U.S. export laws and regulations.

~~The 3DMed License Agreement includes customary representations and warranties, covenants and indemnification obligations for a transaction of this nature.~~

~~Table of Contents~~

~~SELLAS LIFE SCIENCES GROUP, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued~~

~~(Unaudited)~~

~~Revenue Recognition~~

The Company evaluated the 3DMed License Agreement and concluded that 3DMed was a customer and the 3DMed License Agreement should be evaluated under ASC 606. In determining the appropriate amount of revenue to be recognized under ASC 606 as the Company fulfills its obligations under the 3DMed License Agreement, the Company performs the following steps: (i) identifies the promised goods or services in the contract; (ii) determines whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measures the transaction price, including any constraints on variable consideration; (iv) allocates the transaction price to the performance obligations; and (v) recognizes revenue when (or as) the Company satisfies each performance obligation.

The Company identified the 3DMed License and the transfer of know-how to be the material promises under the 3DMed License Agreement. The Company determined that the 3DMed License and the transfer of know-how are not distinct from each other. As such, for the purposes of ASC 606, the Company determined that these two material promises, described above, should be combined into a single performance obligation.

The Company determined the initial transaction price of the single performance obligation to be $9.5 million, which ~~includes~~included the $7.5 million upfront fee as well as $2.0 million in development milestones that ~~are~~were assessed ~~to be~~as probable of being achieved at the inception of the 3DMed License Agreement and therefore were not constrained. ~~The Company achieved $1.0~~As of December 31, 2021, the full $9.5 million ~~of these milestones in the first quarter of 2021 and achieved the remaining $1.0 million milestone in the second quarter of 2021.~~initial transaction price was fully recognized as licensing revenue. The Company determined that the remaining $192.5 million in certain future ~~certain~~ development, regulatory, and sales milestones ~~to be~~is variable consideration subject to constraint at inception. At the end of each ~~subsequent~~ reporting period, the Company ~~will reevaluate~~reevaluates the probability of achievement of the future development, regulatory, and sales milestones subject to constraint and, if necessary, will adjust its estimate of the overall transaction price. Any such adjustments will be recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.

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SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

On March 31, 2022, the Company announced that an IND application filed by 3DMed, pursuant to its 3DMed License Agreement for GPS, for a small Phase 1 clinical trial investigating safety of GPS in China was approved by China's NMPA. The IND approval by the NMPA triggered a $1.0 million milestone payment to the Company which was recognized as licensing revenue in the first quarter of 2022 and payment was received in May 2022. An additional $191.5 million in potential future development, regulatory, and sales milestones, not including future royalties, remains under the 3DMed License Agreement as of June 30, 2022, which milestones are variable in nature and not under the Company's control. The current clinical development plan provides for initiation of a Phase 2 clinical trial following receipt of satisfactory safety data from the Phase 1 clinical trial as well as a Phase 1 or Phase 1/2 clinical trial of GPS in combination with envafolimab, 3DMed’s checkpoint inhibitor which has been approved in China. Under the 3DMed License Agreement, the initiation of a Phase 2 clinical trial will trigger a milestone payment to the Company.

For the sales-based royalties, the Company will recognize revenue when the related sales occur. To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements.

Since 3DMed benefited from the combined single performance obligation relating to the 3DMed License and the transfer of know-how as the technology transfer occurred, the Company recognized the transaction price over the technology transfer period, which was finalized in the second quarter of 2021. The revenue recognized was based on an output method to measure progress, using a straight-line convention, which the Company believes reasonably approximates its efforts in satisfying the combined performance obligation. The Company recognized $1.9 million and $7.6 million of license revenue during the three and six months ended June 30, 2021, respectively. As of June 30, 2021, the initial transaction price of the single performance obligation of $9.5 million has been fully recognized as licensing revenue. There was 0 license revenue recognized during the three ~~and six~~ months ended June 30, ~~2020.~~

~~The following table presents a summary of~~2022, and $1.9 million in license revenue recognized during the ~~activity~~three months ended June 30, 2021. There was $1.0 million and $7.6 million in ~~the Company's deferred~~license revenue ~~related to the total cash payments received of $9.5 million to date under the 3DMed License,~~recognized during the six months ended June 30, 2022 and 2021, ~~(in thousands):~~respectively.

December 31, 2020 Additions Revenue Recognized June 30, 2021
Deferred revenue $ 5,600 $ 2,000 $ (7,600) $ 0

~~Table~~There was 0 cost of ~~Contents~~

~~SELLAS LIFE SCIENCES GROUP, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued~~

~~(Unaudited)~~

~~Cost of Contract Acquisition~~

The Company incurred contract acquisition costs (commissions) recorded as a contract asset amounting to approximately $1.4 million at inception of the 3DMed License Agreement which were capitalized under ASC 340-40 as incremental costs of obtaining the 3DMed License Agreement. These costs are amortized through general and administrative expense over the technology transfer period, commensurate with when the license revenue ~~is recognized. The Company~~ recognized ~~$0.3 million and $1.1 million in expense associated with these costs~~ during the three months ended June 30, 2022, and ~~six~~$0.1 million in cost of license revenue recognized during the three months ended June 30, 2021 ~~respectively. There was 0 contract acquisitions expense during the three and six months ended June 30, 2020.~~

~~Cost of License Revenue~~

~~The Company incurred $0.1 million and $0.2 million of~~for sublicensing fees ~~payable~~incurred under ~~its~~the Company's license from MSK in connection with the 3DMed License ~~during~~Agreement. There was $0.1 million and $0.2 million in cost of license revenues for the ~~three and~~ six months ended June 30, 2022 and 2021, ~~respectively. There was 0 cost of license revenue during~~respectively, for sublicensing fees incurred in connection with the ~~three and six months ended June 30, 2020.~~3DMed License Agreement.

~~10.~~11. Stock-Based Compensation

2017 Equity Incentive Plan

On December 29, 2017, the 2017 Equity Incentive Plan was approved by the stockholders of the Company, which ~~provided~~currently allows for ~~the~~ issuance of up to ~~a maximum of 24,204~~approximately 22,000 shares of common stock underlying stock options granted prior to September 10, 2019. The 2017 Equity Incentive Plan was terminated upon the approval of the 2019 Incentive Plan subject to outstanding stock options granted under the 2017 Equity Incentive Plan that remain exercisable through maturity for the Company's employees and directors.

2019 Equity Incentive Plan

On September 10, 2019, the 2019 Equity Incentive Plan was approved by the stockholders of the Company, which currently allows for issuance of up to approximately ~~(i) 1,191,000~~1,964,000 shares of common stock in connection with the grant of stock-based awards, including stock options, restricted stock, restricted stock units, stock appreciation rights and other types of awards as deemed ~~appropriate plus (ii) 2,684 shares of common stock under the 2017 Equity Incentive Plan that were forfeited back to the Company subsequent to September 10, 2019 and are available for future issuance.~~appropriate.

The number of shares reserved for issuance under the 2019 Equity Incentive Plan will automatically increase on January 1 of each year, for a period of not more than four years, commencing on January 1, 2020 and ending on (and including) January 1, 2023, by an amount equal to the lesser of (i) 5% of the total number of shares of common stock outstanding at the end of the prior fiscal year; and (ii) an amount determined by the board of directors or authorized committee. As of June 30, ~~2021,~~2022, approximately ~~463,000~~666,000 shares of common stock were reserved for future grants under the 2019 Equity Incentive Plan.

The following table summarizes the components of stock-based compensation expense in the consolidated statements of operations for the three and six months ended June 30, 2022 and 2021, respectively (in thousands):

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SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Research and development	$	70	$	35	$	125	$	48
General and administrative	380		229		700		400
Total stock-based compensation	$	450	$	264	$	825	$	448

Options to Purchase Shares of Common Stock

The following table summarizes stock option activity of the Company for the six months ended June 30, ~~2021:~~2022:

Total
Number of
Shares
(In Thousands) Weighted
Average
Exercise
Price Weighted Average Remaining Contractual Term (In Years) Aggregate
Intrinsic
Value
(In Thousands)
Outstanding at December 31, 2020 208 $ 13.38 9.08 $ 733
Granted 312 7.99
Outstanding at June 30, 2021 520 $ 10.14 9.25 $ 2,688
Options exercisable at June 30, 2021 90 $ 23.36 8.48 $ 695


	Total Number of Shares (In Thousands)	Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (In Years)	Aggregate Intrinsic Value (In Thousands)
Outstanding at December 31, 2021	534	$	10.09	8.77	$	681
Granted	478	5.28


Outstanding at June 30, 2022	1,012	$	7.81	8.92	$	67
Options exercisable at June 30, 2022	251	$	13.49	8.07	$	41

1918

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SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

The aggregate intrinsic values of outstanding and exercisable stock options at June 30, ~~2021~~2022 were calculated based on the closing price of the Company’s common stock as reported on the Nasdaq Capital Market on June 30, ~~2021~~2022 of ~~$11.10~~$2.23 per share. The aggregate intrinsic value equals the positive difference between the closing fair market value of the Company’s common stock and the exercise price of the underlying stock options.

The following table summarizes the components of stock-based compensation expense in the consolidated statements of operations for the three and six months ended June 30, 2021 and 2020, respectively (in thousands):

Three Months Ended June 30, Six Months Ended June 30,
2021 2020 2021 2020
Research and development $ 35 $ 4 $ 48 $ 5
General and administrative 229 142 400 286
Total stock-based compensation $ 264 $ 146 $ 448 $ 291

~~The~~ Company uses the Black-Scholes option-pricing model to determine the fair value of all its stock options granted. The weighted average assumptions used during the three and six months ended June 30, ~~2021~~2022 and ~~2020,~~2021, respectively, were as follows:

Three Months Ended June 30, Six Months Ended June 30,
2021 2020 2021 2020
Risk free interest rate 1.12 % 0.53 % 1.04 % 0.62 %
Volatility 121.47 % 108.08 % 121.23 % 106.24 %
Expected lives (years) 6.25 6.25 6.18 6.15
Expected dividend yield 0 % 0 % 0 % 0 %


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Risk free interest rate	2.87	%	1.12	%	1.80	%	1.04	%
Volatility	144.75	%	121.47	%	130.60	%	121.23	%
Expected lives (years)	6.25		6.25		6.21		6.18
Expected dividend yield	—	%	—	%	—	%	—	%

The weighted-average grant date fair value of options granted during the three months ended June 30, 2022 and 2021 was $2.13 and ~~2020 was~~ $6.89, ~~and $1.35,~~ respectively. The weighted-average grant date fair value of options granted during the six months ended June 30, 2022 and 2021 was $4.76 and ~~2020 was~~ $6.97, ~~and $1.53,~~ respectively.

The Company’s expected common stock price volatility assumption is based upon the Company's own implied volatility in combination with the implied volatility of a basket of comparable companies. The expected life assumptions for employee grants were based upon the simplified method, which averages the contractual term of the Company’s options of ten years with the average vesting term of four years for an average of approximately six years. The expected life assumptions for non-employees were based upon the contractual term of the option. The dividend yield assumption is 0zero because the Company has never paid cash dividends and presently has no intention to do so. The risk-free interest rate used for each grant was also based upon prevailing short-term interest rates. The Company accounts for forfeitures as they occur.

As of June 30, ~~2021,~~2022, there was ~~$2.4~~$3.6 million of unrecognized compensation cost related to outstanding stock options that is expected to be recognized as a component of the Company’s operating expenses over a weighted-average period of ~~2.98~~2.88 years.

Time-vested RSUs and RSUs with Performance Conditions

The following table summarizes RSU activity of the Company for the six months ended June 30, ~~2021:~~2022:

Shares
(In Thousands) Weighted Average Grant Date Fair Value
Unvested at December 31, 2020 170 $ 1.89
Granted 40 $ 8.00
Vested 0 $ 0
Unvested at June 30, 2021 210 $ 3.06

~~Table of Contents~~

~~SELLAS LIFE SCIENCES GROUP, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued~~

~~(Unaudited)~~


	Shares (In Thousands)	Weighted Average Grant Date Fair Value
Unvested at December 31, 2021	200	$	2.81
Granted	97	$	5.34

Unvested at June 30, 2022	297	$	3.64

As of June 30, ~~2021,~~2022, there was ~~$0.6~~$1.0 million of unrecognized compensation cost related to outstanding RSUs that is expected to be recognized as a component of the Company's operating expenses over a weighted-average period of ~~2.94~~2.51 years. ~~NaN~~No RSUs vested during the ~~three and~~ six months ended June 30, ~~2021.~~2022.

Table of Contents

SELLAS LIFE SCIENCES GROUP, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

(Unaudited)

2021 Employee Stock Purchase Plan

On April 22, 2021, the Board of Directors adopted the 2021 Employee Stock Purchase Plan ("2021 ESPP") which was approved by the Company's stockholders on June 8, 2021. The 2021 ESPP allows employees to contribute up to 20% of their cash earnings, subject to a maximum of $25,000 per year under Internal Revenue Service rules, to be used to purchase shares of the Company’s common stock on semi-annual purchase dates. The 2021 ESPP allows eligible employees to purchase shares of common stock at a price per share equal to 85% of the lower of the fair market value of the common stock at the beginning or end of each six-month offering period during the term of the 2021 ESPP. ~~The first offering period will begin in September 2021.~~

During the six months ended June 30, 2022, 10,362 shares of common stock were purchased by employees under the 2021 ESPP for proceeds of approximately $47,000. There are currently ~~300,000~~289,638 shares of common stock reserved for issuance under the 2021 ~~ESPP.~~ESPP as of June 30, 2022.

~~11.~~12. Subsequent Events

The Company evaluated all events or transactions that occurred after June 30, ~~2021~~2022 up through the date these financial statements were issued. Other than as disclosed elsewhere in the notes to the consolidated financial statements, the Company did not have any material subsequent events.

2120

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

This management’s discussion and analysis of financial condition as of June 30, ~~2021~~2022 and results of operations for the three and six months ended June 30, ~~2021~~2022 and ~~2020,~~2021, respectively, should be read in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission, or SEC, on March ~~23, 2021,~~31, 2022, or our ~~2020~~2021 Annual Report, and our other public reports filed with the SEC.

Overview

We are a late-stage clinical biopharmaceutical company focused on ~~developing~~the development of novel cancer ~~immunotherapeutics~~therapies for a broad range of ~~cancer~~ indications. Our product development candidates currently include galinpepimut-S, or GPS, and ~~nelipepimut-S.~~GFH009. We are pursuing an out-licensing strategy for a third product candidate, nelipepimut-S, or NPS.

Galinpepimut-S, or GPS

Our lead product candidate, ~~galinpepimut-S, or~~ GPS, is a cancer immunotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center, or MSK, that targets the Wilms tumor 1, or WT1, protein, which is present in 20 or more cancer types. Based on its mechanism of action as a directly immunizing agent, GPS has potential as a monotherapy or in combination with other immunotherapeutic agents to address a broad spectrum of hematologic, or blood, cancers and solid tumor indications.

In January 2020, we commenced in the United States a Phase 3 clinical trial, or the REGAL study, for GPS monotherapy in patients with acute myeloid leukemia, or AML, in the maintenance setting after achievement of second complete remission, or CR2, following successful completion of second-line antileukemic therapy. We expect this study will be used as the basis for submission of a Biologics License Application, or BLA, subject to a statistically significant and clinically meaningful data outcome and agreement with the U.S. Food & Drug Administration, or the FDA. We ~~expect~~plan to enroll approximately 116 patients at ~~up to~~ approximately ~~135~~95 clinical sites ~~primarily~~ in the United States, Europe and ~~Europe~~Asia with a planned interim safety and futility analysis after 80 events (deaths). Under our current planning assumptions, which take into account our best estimates of potential delays, including due to COVID-19, we believe that we will complete enrollment for the REGAL study in early 2023. We continue to face enrollment challenges, which we ~~anticipate~~believe are being experienced throughout our industry, and we plan to activate additional clinical sites in the United States and several countries in Europe and Asia throughout the remainder of 2022. Based upon our current assumptions with respect to completion of enrollment and the estimated survival times for both the treated and control groups in the study, we believe, after discussions with our external statisticians and experts, that the planned interim analysis after 80 events (deaths) per the protocol will ~~take place in~~occur by the end of the first half of ~~2022,~~ 2023, provided that our statistical assumptions and assumptions regarding the ~~ongoing~~impact of COVID-19 on the operations of our clinical sites as well as the duration of the pandemic ~~does not significantly adversely impact~~remain unchanged. Because this analysis is event driven, it may occur at a different time than currently expected.

In December 2020, we entered into an exclusive license agreement with 3D Medicines Inc., or 3DMed, a China-based biopharmaceutical company developing next-generation immuno-oncology drugs, for the development and commercialization of GPS, as well as our ~~projected timeline~~next generation heptavalent immunotherapeutic GPS Plus, which is at preclinical stage, across all therapeutic and diagnostic uses in the Greater China territory (mainland China, Hong Kong, Macau and Taiwan). We have retained sole rights to GPS and GPS Plus outside of the Greater China area. On March 30, 2022, an investigational new drug, or IND, application filed by 3DMed to initiate the first clinical trial in China for ~~enrollment.~~3D189, also known as GPS, was approved by China’s National Medical Products Administration, or NMPA. The IND is for a small Phase 1 clinical trial investigating safety. The approval by the NMPA triggered a $1.0 million milestone payment to the Company which we recognized as license revenue in the first quarter of 2022 and payment was received in the second quarter of 2022.

In December 2018, pursuant to a Clinical Trial Collaboration and Supply Agreement, we initiated a Phase 1/2 multi-arm ~~"basket"~~“basket” type clinical study of GPS in combination with Merck & Co., Inc.’s, or Merck, anti-PD-1 therapy, ~~pembrolizumab (Keytruda®)~~Keytruda® (pembrolizumab). ~~The tumor type currently being studied is~~In 2020, we and Merck determined to focus on ovarian cancer (second or third ~~line)~~line WT1+ relapsed or refractory metastatic ovarian cancer). We reported updated clinical and initial immune response data from this study in June 2021. In February 2022, we reported that we had completed enrollment of 17

evaluable patients in this study. In May 2022, we reported the following preliminary data from 15 of the 17 evaluable patients:

•An ad hoc analysis of clinical outcomes showed a disease control rate, or DCR, which is the sum of overall response rate and rate of stable disease, of 53.9 percent at a median follow-up of 43.1 weeks. In a study of a similar platinum-resistant ovarian cancer patient population treated with a checkpoint inhibitor alone, the observed DCR was 37.2 percent. This is consistent with a DCR rate increase of 45 percent in the patients treated with the GPS combination with pembrolizumab over that seen for checkpoint inhibitors alone.

•Median progression-free survival, or PFS, was 12 weeks compared to 8.4 weeks seen in studies for checkpoint inhibitors alone with similar patient populations, which is a 43 percent increase in the GPS combination with pembrolizumab. Patients with fewer previous lines of chemotherapy experienced a more favorable median PFS than those with more than two previous lines: for patients with two or fewer previous lines of therapy treated with GPS in combination with pembrolizumab, median PFS was 24 weeks.

•With 43.1 weeks of follow-up the median overall survival, or OS, has not been reached.

•The safety profile of GPS in combination with pembrolizumab was similar to pembrolizumab alone, with only the addition of low-grade rapidly resolving local reactions at the GPS injection site, consistent with observations from other GPS clinical studies.

The final data analysis for all evaluable patients is expected by the end of 2022.

In February 2020, we commenced a Phase I1 open-label investigator-sponsored clinical trial of GPS, in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab (Opdivo®), in patients with malignant pleural mesothelioma, or MPM, who harbor relapsed or refractory disease after having received frontline standard of care multimodality therapy ~~(the "MPM IST")~~at MSK. Completion of enrollment of a target total of 10 evaluable patients is expected during the second half of 2022. In June 2022, we announced the following updated data from eight evaluable patients in this study, seven of which received at least three doses of GPS, the last given in combination with nivolumab:

•Of the eight evaluable patients, 75 percent of the patients entered the study as Stage III or IV patients, with 50 percent of patients entering as Stage IV. Initial tumor stages were II (two patients), III and IIIB (two patients) and IV (four patients). All patients had the MPM epithelioid and/or sarcomatoid variant, a tumor which is universally expressing WT1.

•Median OS calculated as the time from the cessation of the most recent previous therapy until confirmed death or most recent data update for patients who are still alive (50 percent of patients) was ~~commenced~~40.9 weeks (9.4 months) for all eight patients and 45.7 weeks (10.5 months) in patients who received the combination therapy (seven out of eight patients). The median PFS was 11.1 weeks for all eight patients and 11.9 weeks in patients who received the combination therapy.

•The safety profile of the GPS-nivolumab combination was similar to that seen with nivolumab alone, with the addition of only low-grade, temporary local reactions at ~~MSK.~~the GPS injection site, consistent with previously performed clinical studies with GPS. No Grade 3/4 toxicities were observed for GPS and there were no dose-limiting toxicities.

GPS was granted Orphan Drug Product Designations from the FDA, as well as Orphan Medicinal Product Designations from the European Medicines Agency, or EMA, for GPS in AML, MPM, and multiple myeloma, or MM, as well as Fast Track ~~Designation~~designation for AML, MPM, and MM from the FDA.

GFH009

On March 31, 2022, we entered into an exclusive license agreement with GenFleet Therapeutics (Shanghai), Inc., or GenFleet, a clinical-stage biotechnology company developing cutting-edge therapeutics in oncology and immunology, that grants rights to us for the development and commercialization of GFH009, a highly selective small molecule cyclin-dependent kinase 9, or CDK9, inhibitor, across all therapeutic and diagnostic uses worldwide outside of mainland China, Hong Kong, Macau and Taiwan.

CDK9 activity has been shown to correlate negatively with overall survival in a number of cancer types, including hematologic cancers, such as AML and lymphomas, as well as solid cancers, such as osteosarcoma, pediatric soft tissue sarcomas, and melanoma, and endometrial, lung, prostate, breast and ovarian cancer. As demonstrated in pre-clinical and clinical data, to date, GFH009’s high selectivity has the potential to reduce toxicity as compared to older CDK9 inhibitors and other next-generation CDK9 inhibitors currently in clinical development.

GFH009 is currently in a Phase 1 clinical trial in the United States and China. There are currently six dose levels in this dose-escalating trial of up to 80 patients (2.5 mg, 4.5 mg, 9 mg, 15 mg, 22.5 mg, and 30 mg), administered twice-a-week, and the indications are relapsed/refractory AML, chronic lymphocytic leukemia, or CLL, small lymphocytic leukemia, or SLL, and lymphoma. We may further increase the twice-a-week dose regimen beyond 30 mg, if warranted, which will be based on efficacy, safety and pharmacokinetic parameters, among others. The primary goal of the trial is to establish the recommended Phase 2 dose and to assess safety. We expect enrollment in the planned cohorts in the trial to be completed by the end of 2022. As of August 4, 2022, we have observed the following:

•Among the 30 patients evaluable for safety and efficacy, there have been no dose limiting toxicities, or DLTs, with doses up to 22.5 mg (given twice a week) for the AML cohort and up to 15 mg for the lymphoma cohort and no grade 3 or 4 neutropenias that fall under the DLT definition have been observed.

•In the initial data from the first five dose levels for the AML patients, significant anti-leukemic effects (i.e., greater or equal to 50 percent decrease in bone marrow blasts following GFH009 monotherapy) have been observed in two AML patients treated sufficiently long enough to assess efficacy at previous dose levels.

•Four lymphoma patients achieved stable disease (three at 4.5 mg and one at 9 mg); One patient with peripheral T cell lymphoma treated at 9 mg had a 62% decrease in the sum of the product of the perpendicular diameters for multiple lesions based on a computed tomography, or CT, scan.

In July 2022, we announced that a second, once-a-week dose cohort has been added in the study. Given that both AML and lymphoma patients tolerated all dose levels studied to date with the twice-a-week administration as well as the efficacy signals seen with both AML and lymphoma patients, we have amended the protocol for the study to introduce an additional single-dose cohort to study GFH009 once-a-week administration starting at the higher dose level of 30 mg. The new, weekly single-dose cohort regimen will commence at 30mg and escalate. The amended protocol allows us to expand our knowledge of the drug’s safety and efficacy profile, including observing whether efficacy could be increased beyond what has already been seen with twice-a-week dosing.

Following completion of the Phase 1 clinical trial and determination of the recommended Phase 2 dose, we intend to commence a Phase 2 clinical trial of GFH009 in combination with venetoclax and azacitidine in AML patients. The current standard of care for most AML patients, including older patients, is venetoclax in combination with a hypomethylating agent such as azacitidine. GFH009 has shown in preclinical models a strong synergy with venetoclax. The goal of the Phase 2 clinical trial, which we expect to initiate by the end of the second quarter of 2023, would be to show improved efficacy of venetoclax and would include patients who are resistant to venetoclax. We also intend to commence a Phase 1/2 basket clinical trial of monotherapy GFH009 in pediatric soft tissue sarcomas including Ewing’s sarcoma and rhabdomyosarcoma in late 2022 or early 2023 and complete by the end of 2023. We believe positive results from this program could provide the basis for a rare pediatric disease priority voucher.

Nelipepimut-S or NPS

Nelipepimut-S, or NPS, is a cancer immunotherapy ~~targeting the~~that targets human epidermal growth factor receptor 2, or HER2, expressing cancers. Data presented in 2018 from a Phase 2b clinical trial of the combination of trastuzumab (Herceptin®) plus NPS in HER2 low expressing (1+ or 2+ per immunohistochemistry, or IHC) breast cancer patients in the adjuvant setting to prevent recurrences showed a clinically and statistically significant improvement in the disease-free survival, or DFS, rate for the triple negative breast cancer, or TNBC, cohort at 24 months for patients treated with NPS plus trastuzumab of 92.6% compared to 70.2% for those treated with trastuzumab alone. Following ongoing discussions with the FDA and based upon written feedback from the FDA and on the totality of clinical, safety and translational NPS data to date, we have finalized the design and plan for a Phase 3 registration-enabling study of NPS in combination with trastuzumab for the treatment of patients with TNBC in the adjuvant setting after standard treatment. If successful, we believe this study may be considered as the basis for a BLA submission to the FDA. We ~~are seeking out-licensing opportunities to fund and conduct the future clinical development of NPS in order to maximize the potential of the program and we~~ do not currently plan to conduct ~~and~~or fund a ~~Phase 3~~further development program for NPS ~~on our own.~~

~~GPS Program Update~~and are seeking to out-license the asset.

In June 2021, we reported encouraging updated clinical data from the MPM IST. For the four evaluable patients, all of whom had the epithelioid and/or sarcomatoid variant and have received and progressed with, or are refractory to, frontline pemetrexed-based chemotherapy, the average overall survival, or OS, was 35.3 weeks with a median OS of 35.4 weeks at a median follow-up of 35.4 weeks. OS for relapsed/refractory patients receiving standard of care (pemetrexed, a chemotherapy) is approximately 28 weeks.Average progression-free survival, of PFS, was 8.8 weeks with a median PFS of seven weeks at a median follow-up of 35.4 weeks. The safety profile of the GPS-nivolumab combination was similar to that seen with nivolumab alone, with the addition of only low-grade, temporary local reactions at the GPS injection site which was consistent with previous clinical studies of GPS.

In June 2021, we also reported updated clinical data and immune response profiles from the basket study of GPS in combination with pembrolizumab for treating WT1+ advanced ovarian cancer. Of the 11 evaluable patients, 66.7% were refractory to or had failed their second-line therapies and 33.3% had failed third-line or later therapy and all patients were resistant to the standard of care platinum-based therapy. The expected overall survival for patients receiving standard of care platinum-based therapy is nine to 12 months. The median OS among the patients in this trial is not yet known as all patients remained alive at the time of analysis which time period exceeds nine months. In an ad hoc analysis of the clinical outcomes for the cohort of 11 patients, the disease control rate, or DCR, which is the sum of overall response rate and rate of stable disease, was 63.6% with a median follow-up of 15.4 weeks. At the time of follow-up analysis, median PFS was 11.8 weeks. The safety profile of the GPS-pembrolizumab combination was similar to that seen with pembrolizumab alone, with the addition of only low-grade, temporary local reactions at the GPS injection site, consistent with previously performed clinical studies with GPS. We also reported immunobiological data from this study. CD8+ and CD4+ T-lymphocytes were isolated from peripheral blood mononuclear cells from three patients from whom samples had been collected both at baseline and at the time of the sixth GPS dose (i.e., 18 weeks after starting investigational therapy). The T-cells were assayed ex-vivo for immune responses against the pool of the four peptides that comprise GPS using the validated assay intracellular cytokine staining with fluorescence-activated single cell sorting (ICS-FACS) (Scorpion Biological Services, San Antonio, Texas), with appropriate positive and negative controls. A total of five cytokine “channels” were used for the analysis (i.e., interferon-g, TNF-a, interleukin-2, CD107a and MIP-1b). The peptide re-challenge incubation period was seven days. At the 18-week time point versus pre-vaccination baseline, the assay demonstrated a relative increase in WT1-specific T-lymphocyte frequencies in peripheral blood averaging +242% (range: +104 to +385% across five cytokines) for CD8+ and +80.5% (range: +1 to +174%) for CD4+. There was also evidence of polyfunctional T-cell activation (increases in secretion of >2 cytokines) in two out of three patients (66%).

~~In June 2021, a peer-reviewed article was published in the journal~~ ~~Bone Marrow Transplantation~~ which included a comprehensive retrospective analysis of survival outcomes in 4,280 AML patients treated in more than 450 blood and marrow transplant centers worldwide between 2007 and 2015. The analysis demonstrates the high unmet medical need to extend survival in AML patients. The published analysis showed that even among patients eligible to receive a bone marrow transplant, considered to be the only potential curative therapy in AML, less than half of the patients are alive five years after initial diagnosis. The analysis highlights the importance of the presence of minimal residual disease, or MRD, with patients who harbored MRD at the time of transplant having only 34%-37% probability of surviving five years. In our completed Phase 2 study of AML patients who achieved first remission, or CR1, OS for patients treated with GPS was 48.5 months from time of enrollment in the study. The retrospective analysis of the pooled outcomes for AML patients who underwent a transplant in the article published in ~~Bone Marrow Transplantation~~ ~~indicates that the median OS from the time of transplant is approximately 26 months. In our Phase 2 AML CR1 study the median OS from the time of initial AML diagnosis was 67.6 months.~~

Impact of COVID-19

~~On March 11, 2020,~~The ongoing global COVID-19 pandemic, including the ~~World Health Organization declared~~surges of cases from the ~~outbreak~~Delta and Omicron variants, continues to disrupt our business operations and those of ~~a new coronavirus to be a “pandemic”.~~our collaborators, including 3D Med and GenFleet, contractors, contract research organizations, or CROs, suppliers, clinical sites, contract manufacturing organizations, or CMOs, and other partners. The COVID-19 pandemic ~~continues~~has affected and may continue to ~~present substantial public~~affect the health and ~~economic challenges around the world which have impacted,~~availability of our workforce and ~~will continue to impact, millions of individuals and businesses worldwide. Efforts to contain the spread~~that of the ~~coronavirus since March 2020 have led~~third-parties we rely on, such as our CROs, clinical sites, CMOs, and other contractors as well as the governmental agencies, such as the FDA and health authorities in other countries which could delay or otherwise adversely impact the ability of such parties to travel bans and restrictions, quarantines, shelter-in-place orders and shutdowns. As we have historically functioned operationally as a semi-virtual company, the transition to “work-from-home” for our employees has not materially altered our business operations.fulfill their obligations. We have implemented a return-to-work policy in compliance with federal, state and local requirements and guidance, which provides for a hybrid of remote and in-office ~~work, and we have operated on such a semi-virtual basis during the first half of 2021.~~work. We are continuously monitoring the impact of the pandemic on our clinical development ~~programs.~~programs and on those of our partners, 3DMed and GenFleet. Our Phase 3 REGAL study is progressing, with the necessary work to activate additional sites in the United States, Europe and ~~Europe~~Asia continuing. ~~Throughout 2020 and first half~~However, since the onset of ~~2021, we initiated additional sites as planned. However,~~the COVID-19 pandemic, we have observed that, at certain times and in certain instances, clinical site initiations, patient screening and patient enrollment ~~may be delayed~~have been delayed. These delays are likely due to many reasons, which have been changing and evolving as the COVID-19 pandemic itself has evolved, including the prioritization of hospital resources towards the care of patients with COVID-19, ~~pandemic. Clinicians~~delays in reviews and approvals by independent institutional review boards, or IRBs, and/or ethics committees at clinical sites, the challenges for clinicians and patients ~~may not be able~~ to comply with clinical trial protocols ifdue to quarantines ~~impede~~impeding patient movement or ~~interrupt~~interrupting operations at ~~sites. Accordingly, we are uncertain~~sites, restrictions on travel and, most recently, inadequate staffing at ~~this time~~clinical sites, supply chain-related delays, materials shortages and, most recently, lockdowns in China. Throughout the ~~extent to which these~~United States, Europe and Asia, newly initiated sites ~~will be~~have taken longer than expected to become fully operational ~~which we believe could have an impact on the projected timing~~and begin enrolling patients. We are continuing to monitor each clinical site through our CROs as well as conducting direct outreach to investigators and study staff through site visits investigator meetings and other modes of the REGAL study. Additionally, several European Union countries in which we plan to initiate clinical sites, including Germany, France, and Italy, continue to impose restrictions in response to the continued surge in coronavirus cases throughout the European Union. We believe that the COVID-19 pandemic has not materially impacted our efforts to out-license NPS.communication. The full extent to which the COVID-19 pandemic will continue to directly or indirectly ~~impacts~~impact our business, results of operations and financial condition will depend on future developments that are highly uncertain, subject to change and cannot be predicted with confidence, including the ~~actions taken to contain or treat COVID-19, the ultimate overall~~ duration of the ~~pandemic,~~outbreak, the continued availability and efficacy of vaccines, new information which may emerge concerning the severity of COVID-19, the emergence of new variants of COVID-19, the ~~emergence of new geographic hotspots where the coronavirus is spreading more rapidly, and continued~~actions to contain COVID-19 or treat its impact, including continuing or new travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, as well as the effectiveness of actions taken globally to contain and treat the coronavirus, including the availability of safe and effective vaccineslockdowns, among others, and the ~~uptake thereof~~direct and ~~whether existing vaccines are effective with respect to new variants. In particular, the continued spread~~indirect economic effects of the ~~coronavirus globally could adversely impact our clinical trial operations~~pandemic, including as a result of inflation, supply chain disruptions and ~~could have an adverse impact on our business and the financial results.~~

labor shortages.

Components of Results of Operations

License Revenue

License revenue consists of revenue recognized pursuant to our Exclusive License Agreement with ~~3D Medicines Inc., or~~ 3DMed dated December 7, 2020, or the 3DMed License Agreement. In the future, we may generate revenue from a combination of reimbursements, up-front payments, milestone payments and royalties in connection with the 3DMed License Agreement.

Cost of License Revenue

Cost of license revenue consists of sublicensing fees ~~payable~~incurred under our license from MSK in connection with the 3DMed License Agreement.

Research and Development Expense

Research and development expense consists of expenses incurred in connection with the discovery and development of our product candidates. We expense research and development costs as incurred. These expenses include:

•expenses incurred under agreements with CROs, as well as investigative sites and consultants that conduct our preclinical studies and clinical trials;

•manufacturing expenses;

•quality control and quality assurance services;

•outsourced professional scientific development services;

•employee-related expenses, which include salaries, benefits and stock-based compensation;

•payments made under our license agreements, under which we acquired certain intellectual property;

•expenses relating to certain regulatory activities, including filing fees paid to regulatory agencies;

•laboratory materials and supplies used to support our research activities; and

•allocated expenses, utilities and other facility-related costs.

The successful development of our current and future product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or when, if ever, material net cash inflows may commence from any current or future product candidates. This uncertainty is due to the numerous risks and uncertainties associated with the duration and cost of our clinical trials, which vary significantly over the life of a project as a result of many factors, including, but not limited to:

•the number of clinical sites and participating countries included in the trials;

•the length of time required to enroll suitable patients;

•the number of patients that ultimately participate in the trials;

•the number of doses patients receive;

•the duration of patient follow-up;

•the results of clinical trials;

•the expenses associated with manufacturing;

•the receipt of marketing approvals;

•the commercialization of current and future product candidates; and

•the impact of the COVID-19 pandemic.

Research and development activities are central to our business model. ~~Cancer immunotherapy~~Oncology product candidates in the later stages of clinical development generally have higher development costs than those in the earlier stages of clinical development, primarily due to the increased size and duration of the later-stage clinical trials. We expect our research and development expenses to increase for the foreseeable future as we conduct and complete our ongoing early and late stage clinical trials and initiate additional clinical trials.

Our expenditures are subject to additional uncertainties, including the terms and timing of regulatory approvals. We may never succeed in achieving regulatory approval for any of our current or future product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or target indications or focus on others. A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials due to the COVID-19 pandemic or otherwise, we could be required to expend significant additional financial resources and time on the completion of clinical development. ~~Cancer immunotherapy~~

Acquired In-Process Research and Development

Acquired in-process research and development consists of costs to acquire or license product ~~commercialization may take several years and millions of dollars in~~candidates from third-parties for development ~~costs.~~with no alternative future use.

General and Administrative Expense

General and administrative expenses consist principally of salaries and related costs for personnel in executive, administrative, finance and legal functions, including stock-based compensation, travel expenses and recruiting expenses, fees for outside legal counsel, amortization of contract acquisition costs (commissions), and director and officer insurance premiums. Other general and administrative expenses include facility related costs, patent filing and prosecution costs, professional fees for business development, accounting, consulting, legal and tax-related services associated with maintaining compliance with our Nasdaq listing and SEC reporting requirements, investor relations costs, and other expenses associated with being a public company.

If and when we believe that regulatory approval of a product candidate appears likely, we anticipate that an increase in general and administrative expenses will occur as a result of our preparation for commercial operations, particularly as it relates to the sales and marketing of such product candidate. ~~Cancer immunotherapy~~Oncology product commercialization may take several years and millions of dollars in development costs.

Non-Operating Income (Expense) ~~Income,~~, Net

Non-operating income (expense) ~~income,~~, net consists of changes in fair value of our warrant liability, changes in fair value of our contingent consideration, and interest income. Interest income primarily reflects interest earned from our cash and cash equivalents.

Critical Accounting Policies and Estimates

In the ~~2020~~2021 Annual Report, we disclosed our critical accounting policies and estimates upon which our financial statements are derived. There have been no material changes to these policies since December 31, ~~2020~~2021 that are not included in Note 3 of the accompanying consolidated financial statements for the six months ended June 30, ~~2021.~~2022. Readers are encouraged to read the ~~2020~~2021 Annual Report in conjunction with this Quarterly Report on Form 10-Q.

Results of Operations for the Three and Six Months Ended June 30, ~~2021~~2022 and ~~2020~~2021

The following table summarizes our results of operations for the three ~~months ended June 30, 2021~~ and ~~2020 (in thousands):~~

Three Months Ended June 30,
2021 2020 Change
Licensing revenue $ 1,900 $ — $ 1,900
Operating expenses:
Cost of license revenue 100 — 100
Research and development 3,456 2,280 1,176
General and administrative 2,797 1,987 810
Total operating expenses 6,353 4,267 2,086
Loss from operations (4,453) (4,267) (186)
Non-operating expense, net (160) (158) (2)
Net loss $ (4,613) $ (4,425) $ (188)

~~The following table summarizes our results of operations for the~~ six months ended June 30, ~~2021~~2022 and ~~2020~~2021 (in thousands):


		Six Months Ended June 30,							Three Months Ended June 30,
		2021		2020		Change			2022		2021		Change
Licensing revenue	Licensing revenue	$	7,600	$	—	$	7,600	Licensing revenue	$	—	$	1,900	$	(1,900)
Operating expenses:	Operating expenses:							Operating expenses:
Cost of license revenue	Cost of license revenue	200		—		200		Cost of license revenue	—		100		(100)
Research and development	Research and development	7,740		4,144		3,596		Research and development	5,529		3,456		2,073
Acquired in-process research and development								Acquired in-process research and development	—		—		—
General and administrative	General and administrative	6,358		4,187		2,171		General and administrative	3,094		2,797		297
Total operating expenses	Total operating expenses	14,298		8,331		5,967		Total operating expenses	8,623		6,353		2,270
Loss from operations		(6,698)		(8,331)		1,633
Non-operating expense, net		(318)		(237)		(81)

Operating loss								Operating loss	(8,623)		(4,453)		(4,170)
Non-operating income (expense), net								Non-operating income (expense), net	209		(160)		369
Net loss	Net loss	$	(7,016)	$	(8,568)	$	1,552	Net loss	$	(8,414)	$	(4,613)	$	(3,801)


	Six Months Ended June 30,
	2022		2021		Change
Licensing revenue	$	1,000	$	7,600	$	(6,600)
Operating expenses:
Cost of license revenue	100		200		(100)
Research and development	10,140		7,740		2,400
Acquired in-process research and development	10,000		—		10,000
General and administrative	6,118		6,358		(240)
Total operating expenses	26,358		14,298		12,060
Operating loss	(25,358)		(6,698)		(18,660)
Non-operating income (expense), net	200		(318)		518
Net loss	$	(25,158)	$	(7,016)	$	(18,142)

Further analysis of the changes and trends in our operating results are discussed below.

Licensing Revenue

~~Licensing~~There was no licensing revenue for the three ~~and six~~months ended June 30, 2022. Licensing revenue was $1.9 million for the three months ended June 30, 2021 ~~was $1.9 million and $7.6 million, respectively, and~~ related to the initial transaction price of $9.5 million under the 3DMed License Agreement, which was recognized over a period of time to satisfy the out-licensing of intellectual property rights and transfer of technical ~~know-how associated with the 3DMed License Agreement for the development and commercialization of GPS in China, Hong Kong, Macau, and Taiwan. There~~know-how.

Licensing revenue was ~~no licensing revenue~~$1.0 million for the six months ended June 30, ~~2020.~~2022 related to an approval by the NMPA of an IND application for a small Phase 1 clinical trial investigating safety of GPS in China, which triggered a development milestone under the 3DMed License Agreement. Licensing revenue was $7.6 million for the six months ended June 30, 2021 related to the initial transaction price of $9.5 million under the 3DMed License Agreement, which was recognized over a period of time to satisfy the out-licensing of intellectual property rights and transfer of technical know-how.

Cost of License Revenue

There was no cost of licensing revenue during the three months ended June 30, 2022. We incurred $0.1 million of sublicensing fees payable under our license from MSK in connection with the 3DMed License Agreement during the three months ended June 30, 2021.

We incurred $0.1 million and $0.2 million of sublicensing fees payable under our license from MSK in connection with the 3DMed License Agreement during the ~~three and~~ six months ended June 30, 2022 and 2021, respectively. ~~There was no cost of license revenue during for the six months ended June 30, 2020.~~

Research and Development

Research and development expenses were $5.5 million for the three months ended June 30, 2022 compared to $3.5 million for the three months ended June 30, ~~2021 compared to $2.3 million for the three months ended June 30, 2020.~~2021. The ~~$1.2~~$2.0 million increase was primarily attributable to a ~~$0.8~~$0.9 million increase in manufacturing expenses due to the purchase of drug supply and manufacturing of a registration batch of GPS, a $0.6 million increase in clinical trial expenses primarily related to our ongoing Phase 3 REGAL clinical trial of GPS in AML, a $0.4 million increase in ~~manufacturing and drug supply costs~~personnel related expenses due to ~~the ramp up of the manufacture of clinical trial materials and registration batches of GPS,~~increased headcount, and a $0.1 million increase in ~~personnel related expenses due to increased headcount. These increases were partially offset by a $0.1 million decrease in licensing fees.~~clinical and regulatory consulting expenses. We anticipate that our research and development expenses will increase in the future as we continue to advance the development of GPS and GFH009, including our Phase 3 clinical trial of GPS in AML, ~~and~~ the ongoing basket trial of GPS in combination with ~~pembrolizumab.~~pembrolizumab, and the ongoing Phase 1 clinical trial of GFH009.

Research and development expenses were $10.1 million for the six months ended June 30, 2022 compared to $7.7 million for the six months ended June 30, ~~2021 compared to $4.1 million for the six months ended June 30, 2020.~~2021. The ~~$3.6~~$2.4 million increase was primarily attributable to a $1.7 million increase in manufacturing and drug supply costs due to the ramp up of the manufacture of clinical trial materials and registration batches of GPS, a technology transfer to a new contract manufacturer, and clinical drug supply purchase costs in the European Union as we prepared to open sites and enroll patients in European Union countries for our Phase 3 REGAL clinical trial for GPS in AML, a $1.5$1.9 million increase in clinical trial expenses primarily related to our ongoing Phase 3 REGAL clinical trial ~~for~~of GPS in AML and a ~~$0.3~~$0.7 million increase in personnel related expenses due to increased ~~headcount,~~headcount. These increases were partially offset by a $0.2 million decrease in manufacturing expenses due to the timing of the manufacturing of registration batches of GPS in the prior year. We anticipate that our research and ~~a $0.1 million~~development expenses will increase in the future as we continue to advance the development of GPS and GFH009, including our Phase 3 clinical trial of GPS in AML, the ongoing basket trial of GPS in combination with pembrolizumab, and ~~regulatory consulting costs.~~the ongoing Phase 1 clinical trial of GFH009.

Acquired In-Process Research and Development

There was no acquired in-process research and development expense during the three months ended June 30, 2022. During the six months ended June 30, 2022, we recognized $10.0 million for the acquisition of in-process research and development related to the in-licensing of GFH009, $4.5 million of which was paid in April 2022 and the remaining $5.5 million which was deemed probable to occur and expected to be paid by the end of the second quarter of 2023. There was no acquired in-process research and development during the three and six months ended June 30, 2021.

General and Administrative

General and administrative expenses were $3.1 million for the three months ended June 30, 2022 compared to $2.8 million for the three months ended June 30, ~~2021 compared to $2.0 million for the three months ended June 30, 2020.~~2021. The ~~$0.8~~$0.3 million increase was primarily due to a ~~$0.3 million amortization expense of our contract asset associated with the 3DMed License Agreement, a $0.4~~$0.5 million increase in ~~legal fees as compared~~personnel expenses due to ~~the second quarter of 2020 in which we received a credit in legal fees that offset the majority of legal expenses incurred for the quarter, and~~increased headcount, including a $0.2 million increase in ~~personnel related expenses due to a $0.1 million increase in stock based-based~~non-cash stock-based compensation, ~~and increased headcounts. These increases were~~which was partially offset by a ~~$0.1~~$0.2 million decrease in ~~other general~~outside services and ~~administrative related expenses.~~public company costs.

General and administrative expenses were $6.1 million for the six months ended June 30, 2022 compared to $6.4 million for the six months ended June 30, ~~2021 compared to $4.2~~2021. The $0.3 million ~~for the six months ended June 30, 2020. The $2.2 million increase~~decrease was primarily due to a $1.1 million decrease related to the amortization ~~expense~~ of ~~our~~ contract asset costs associated with the 3DMed License Agreement ~~as well as~~in the prior year with no comparable expense in the current year, a ~~$0.8~~$0.3 million ~~increase~~decrease in legal fees, ~~as compared to the first half of 2020 in which we received a credit in legal fees that offset the majority of legal expenses incurred for the period,~~ and a ~~$0.3~~$0.1 million decrease in accounting fees. These decreases were partially offset by a $0.9 million increase in personnel related expenses due to increased headcount, including a ~~$0.1~~$0.3 million increase in non-cash stock-based compensation, and ~~increased headcount.~~a $0.3 million increase in outside services and public company costs.

Non-Operating Income (Expense), Net

~~Non-Operating Income (Expense), Net~~

Non-operating income (expense), net for the three and six months ended June 30, ~~2021~~2022 and ~~2020,~~2021, respectively, was as follows (in thousands):


		Three Months Ended June 30,						Six Months Ended June 30,							Three Months Ended June 30,						Six Months Ended June 30,
		2021		2020		Change		2021		2020		Change			2022		2021		Change		2022		2021		Change
Change in fair value of warrant liability	Change in fair value of warrant liability	$	(28)	$	(16)	$	(12)	$	(59)	$	19	$	(78)	Change in fair value of warrant liability	$	48	$	(28)	$	76	$	37	$	(59)	$	96
Change in fair value of contingent consideration	Change in fair value of contingent consideration	(134)		(143)		9		(263)		(281)		18		Change in fair value of contingent consideration	115		(134)		249		115		(263)		378
Interest income	Interest income	2		1		1		4		25		(21)		Interest income	46		2		44		48		4		44
Total non-operating expense, net		$	(160)	$	(158)	$	(2)	$	(318)	$	(237)	$	(81)
Total non-operating income (expense), net														Total non-operating income (expense), net	$	209	$	(160)	$	369	$	200	$	(318)	$	518

Net non-operating income ~~(expense) was nominal for~~of $0.2 million during the three and six months ended June 30, ~~2021~~2022 was primarily due to decreases in the fair value of the contingent consideration liability driven by an increase in discount rates, a decrease in the fair value of the warrant liability driven by a decrease in our common stock price, and ~~2020.~~an increase in interest income earned from our cash and cash equivalents.

Net non-operating expense of $0.2 million and $0.3 million ~~during~~for the three and six months ended June 30, 2021, respectively, was primarily due to ~~the increase~~increases in the change in the fair value of the contingent consideration liability and a slight increase in the change in the fair value of the warrant liability partially offset by nominal interest income. The change in the fair value of the contingent consideration liability ~~reflects~~reflected the interest component of contingent consideration related to the passage of time. The increase in the estimated fair value of our warrant liability was primarily due to an increase in our common stock price. Interest income consisted of interest earned from our cash and cash equivalents.

The change in fair value of warrant liability and change in fair value of contingent consideration are non-cash in nature.

Income Tax Expense

There was no income tax expense for the three and six months ended June 30, ~~2021~~2022 and ~~2020.~~2021. We continue to maintain a full valuation allowance against our net deferred tax assets.

Liquidity and Capital Resources

We did not generate any revenue from product sales during the ~~three and~~ six months ended June 30, ~~2021~~2022 and ~~2020.~~2021. Through June 30, ~~2021,~~2022, the Company has only generated licensing revenue from the 3DMed License Agreement. Since inception, we have incurred net losses, used net cash in our operations, and have funded substantially all of our operations through proceeds of the sale of equity securities and convertible notes.

On April 5, 2022, we consummated an underwritten public offering, or the April 2022 Offering, issuing 4,629,630 shares of common stock and accompanying common stock warrants to purchase an aggregate of 4,629,630 shares of common stock. The shares of common stock and accompanying common stock warrants were sold at a combined price of $5.40 per share and accompanying common stock warrant. Each common stock warrant sold with the shares of common stock represents the right to purchase one share of our common stock at an exercise price of $5.40 per share. The common stock warrants are exercisable immediately and will expire on April 5, 2027, five years from the date of issuance. The net proceeds to us from the April 2022 Offering, after deducting the underwriting discounts and commissions and other offering expenses, and excluding the exercise of any warrants, were approximately $23.0 million.

On March 31, 2022, we entered into an exclusive license agreement with GenFleet pursuant to which GenFleet granted to us a sublicensable, royalty-bearing license, to certain of its intellectual property, to develop, manufacture, and commercialize a small molecule CDK9 inhibitor for the treatment, diagnosis or prevention of disease in humans and animals in all countries and territories of the world other than mainland China, Hong Kong, Macau and Taiwan, or the GFH009 Territory. The CDK9 inhibitor, GFH009, is currently in a Phase 1 clinical trial in the United States and China.

In consideration for the exclusive license, we agreed to pay GenFleet (i) an upfront and technology transfer fee of $10.0 million, of which $4.5 million was paid in April 2022, and $5.5 million is due upon the first day of the

15th calendar month following the effective date of the license agreement, (ii) development and regulatory milestone payments for up to three indications totaling up to $48.0 million in the aggregate, and (iii) sales milestone payments totaling up to $92.0 million in the aggregate upon the achievement of certain net sales thresholds in a given calendar year. We have also agreed to pay GenFleet single-digit tiered royalties based upon a percentage of annual net sales, with the royalty rate escalating based on the level of annual net sales of GFH009 in the GFH009 Territory ranging from the low to high single digits.

On March 31, 2022, we announced that an IND application filed by 3DMed, pursuant to its Exclusive License Agreement for GPS, for a small Phase 1 clinical trial investigating safety of GPS in China was approved by China's NMPA. The IND approval by the NMPA triggered a $1.0 million milestone payment to us which was recognized as licensing revenue in the first quarter of 2022 and the payment was received in May 2022. An additional $191.5 million in potential future development, regulatory, and sales milestones, not including future royalties, remains under the 3DMed License Agreement as of June 30, 2022, which milestones are variable in nature and not under our control. 3DMed's current clinical development plan provides for initiation of a Phase 2 clinical trial following receipt of satisfactory safety data from the Phase 1 clinical trial as well as a Phase 1 or Phase 1/2 clinical trial of GPS in combination with envafolimab, 3DMed's checkpoint inhibitor which has been approved in China. Under the 3DMed License Agreement, the initiation of a Phase 2 clinical trial will trigger a milestone payment to the Company.

On April 16, 2021, we entered into a Controlled Equity OfferingSM Sales Agreement, , or the Sales Agreement, with Cantor Fitzgerald & Co., or the ~~"Agent.~~Agent. From time to time during the term of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price up to a total of $50.0 million in gross proceeds. The Agent will collect a fee equal to 3% of the gross sales price of all shares of common stock sold. Shares of common stock sold under the Sales Agreement ~~will be~~are offered and sold pursuant to our registration statement on Form S-3, which was filed with the SEC on April 16, 2021 and ~~was~~ declared effective on April 29, 2021. During the ~~three months~~year ended ~~June 30,~~December 31, 2021, we sold a total of 786,927 shares of ~~our~~ common stock pursuant to the Sales Agreement at an average price of $12.04 per share for aggregate net proceeds of approximately $9.0 million. During the six months ended June 30, 2022, we sold an additional 16,289 shares of common stock pursuant to the Sales Agreement at an average price of $3.16 per share for aggregate gross proceeds of approximately $0.1 million. Approximately $40.5 million remains available for future sales of shares of common stock under the Sales Agreement. Other than the Sales Agreement, we currently do not have any commitments to obtain additional funds.

We received $1.0 million and $2.0 million during the three and six months ended June 30, 2021, respectively, for the achievement of certain development milestones pursuant to our 3DMed License Agreement. An additional $192.5 million in potential future certain development, regulatory, and sales milestones remains under the 3DMed License Agreement which milestones are variable in nature and not under our control.

As of June 30, ~~2021,~~2022, we had an accumulated deficit of ~~$124.9~~$163.8 million, cash and cash equivalents of ~~$29.9~~$27.0 million and restricted cash and cash equivalents of $0.1 ~~million, and a stock subscription receivable of $2.2 million, which cash was received in July 2021.~~million. In addition, we had ~~accounts payable and accrued expenses and other~~ current liabilities of ~~$4.1~~$12.2 million as of June 30, ~~2021.~~2022. We expect that our cash and cash equivalents ~~together with access to the Sales Agreement,~~ will not be sufficient to fund our current planned operations for at least the next twelve months from the date of issuance of these financial statements, although we may pursue additional capital resources through public or private equity or debt financings or by establishing additional collaborations with other companies. Our expectations with respectstatements. These conditions give rise to a substantial doubt over our ability to ~~fund~~continue as a going concern.

We will require substantial additional financing to commercially develop any current ~~planned operations is based on estimates that are subject to risks and uncertainties. If actual results are different from management's estimates,~~or future product candidates. Alternatively, we ~~may need to seek additional strategic or financing opportunities sooner than would otherwise be expected. There is no guarantee that any of these strategic or financing opportunities~~ will be ~~executed or executed~~required to scale back our plans and place certain activities on ~~favorable terms,~~hold. Other than the Sales Agreement, we currently do not have any commitments to obtain additional funds, and ~~some could~~may be ~~dilutive to existing stockholders. If we are~~ unable to obtain ~~additional~~sufficient funding in the future on ~~a timely basis, we~~acceptable terms, if at all. Our management continues to evaluate different strategies to obtain the required funding for future operations. These strategies may ~~be forced to significantly curtail, delay,~~ include utilizing the Sales Agreement, public and private placements of equity and/or ~~discontinue one or more of our planned~~debt securities, payments from potential strategic research and development ~~programs~~ collaborations, and licensing and/or marketing arrangements with pharmaceutical companies. Additionally, we continue to pursue discussions with global and regional pharmaceutical companies for licensing and/or co-development rights to its product candidates. There can be ~~unable to expand our operations or otherwise prepare for the potential regulatory approval and commercialization of our product candidates, assuming positive data.~~no assurance that these future funding efforts will be successful.

Our future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of any additional financings, (ii) our ability to complete revenue-generating partnerships with pharmaceutical and biotechnology companies, (iii) the success of our research and development activities, (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies, and, ultimately, (v) regulatory approval and market acceptance of our proposed future products. ~~on is imminent.~~

Cash Flows

The following table summarizes our cash flows from operating and financing activities for the six months ended June 30, ~~2021~~2022 and ~~2020~~2021 (in thousands):

Six Months Ended June 30,
2021 2020
Net cash (used in) provided by:
Operating activities $ (15,167) $ (10,212)
Financing activities 9,782 6,275
Net decrease in cash, cash equivalents, restricted cash, and restricted cash equivalents $ (5,385) $ (3,937)

~~We had no investing activities during the during the six months ended June 30, 2021 and 2020.~~


	Six Months Ended June 30,
	2022		2021
Net cash (used in) provided by:
Operating activities	$	(12,911)	$	(15,167)
Investing activities	(4,500)		—
Financing activities	23,043		9,782
Net increase (decrease) in cash, cash equivalents, restricted cash, and restricted cash equivalents	$	5,632	$	(5,385)

Net Cash Used in Operating Activities

Net cash used in operating activities of $12.9 million during the six months ended June 30, 2022 was primarily attributable to our net loss of $25.2 million, which was partially offset by various net non-cash charges of $10.8 million and the net change in our operating assets and liabilities of approximately $1.5 million. Net non-cash charges were driven by $10.0 million in expense related to the acquired in-process research and development and $0.8 million in non-cash stock compensation expense. The net change in our operating assets and liabilities of $1.5 million is primarily attributable to an increase in accounts payable of $1.2 million and an increase in accrued expenses and other current liabilities of $0.4 million, which were partially offset by a decrease in operating lease liabilities of $0.1 million.

Net cash used in operating activities of $15.2 million during the six months ended June 30, 2021 was primarily attributable to a $8.9 million change in our operating assets and liabilities and our net loss of $7.0 million, which was offset by various net non-cash charges of $0.7 million. The net change in our operating assets and liabilities of $8.9 million is primarily attributable to a decrease in deferred revenue of $5.6 million, a $1.9 million increase in prepaid expenses and other assets primarily for prepaid insurance premiums and clinical trial costs and a $2.5 million decrease in accounts payable and accrued expenses and other current liabilities, partially offset by a $1.1 million decrease in contract acquisition costs related to the out-licensing of intellectual property rights and transfer of technical know-how associated with the 3DMed License Agreement.

Net Cash Used in Investing Activities

Net cash used in ~~operating~~investing activities of ~~$10.2~~$4.5 million during the six months ended June 30, 2020 was primarily attributable to our net loss of $8.6 million and the prepayment of certain expenses and payment of certain payables. The net change in our operating assets and liabilities of $2.2 million is primarily attributable to an increase in prepaid expenses of $1.4 million and a $0.8 million decrease in accounts payable and accrued expenses and other current liabilities. The increase in prepaid expenses was primarily from payments of $1.0 million for insurance premiums and $0.4 million for clinical trial expenses2022 related to ~~our Phase 3 REGAL study.~~license payments made for the acquisition of in-process research and development under the Company's GenFleet License Agreement.

There was no cash used in investing activities during the six months ended June 30, 2021.

Net Cash Provided by Financing Activities

We generated $23.0 million in net cash from financing activities during the six months ended June 30, 2022 that was due to $23.0 million in aggregate net proceeds received from our underwritten public offering, which closed in April 2022.

We generated $9.8 million of net cash from financing activities for the six months ended June 30, 2021. We received $6.8 million in net proceeds from the issuance of common stock under the Sales Agreement, ~~with an additional $2.2 million in net proceeds received in July 2021,~~ as well as $3.0 million from the exercise of warrants to acquire shares of common stock.

We generated $6.3 million of net cash from financing activities for the six months ended June 30, 2020. We received $6.0 million in net proceeds from the sale of securities in a registered direct offering in January 2020 and $0.3 million from the collection of our stock subscription receivable.

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet financing arrangements as of June 30, ~~2021.~~2022.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Not applicable.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this Quarterly Report on Form 10-Q, our principal executive officer and our principal financial officer (the “Certifying Officer”), evaluated the effectiveness of our disclosure controls and procedures. Disclosure controls and procedures are controls and procedures designed to reasonably assure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934 (the “Exchange Act”), such as this Quarterly Report on Form 10-Q, is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms. Disclosure controls and procedures are also designed to reasonably assure that such information is accumulated and communicated to our management, including the Certifying Officers, as appropriate to allow timely decisions regarding required disclosure. Based on these evaluations, the Certifying Officers have concluded, that, as of the end of the period covered by this Quarterly Report on Form 10-Q:

(a)our disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act was recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms; and

(b)our disclosure controls and procedures were effective to provide reasonable assurance that material information required to be disclosed by us in the reports we file or submit under the Exchange Act was accumulated and communicated to our management, including the Certifying Officers, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended June 30, ~~2021~~2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

3133

PART II - OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

Please refer to Note 67 (Commitments and Contingencies) to our consolidated financial statements contained in Part I, Item 1 (Financial Statements) of this Quarterly Report on Form 10-Q, which is incorporated into this item by reference.

ITEM 1A. RISK FACTORS

Please refer to our note on forward-looking statements on page 2 of this Quarterly Report on Form 10-Q, which is incorporated into this item by reference.

In addition to the other information set forth in this report, you should carefully consider the risk factors discussed in our ~~2020~~2021 Annual ~~Report.~~Report and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022. The risks described in such ~~2020~~2021 Annual Report and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially and adversely affect our business, financial condition, operating results and stock price.

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

None.

3234

ITEM 6. EXHIBITS

Exhibit
#

Description

Form

Exhibit

Filing Date

Exhibit
#

Description

Form

Exhibit

Filing Date

3.1

Composite Amended and Restated Certificate of Incorporation of the Registrant (formerly, Galena Biopharma, Inc.) amended as of December 27, 2017

10-K

3.1

April 13, 2018

3.1

Composite Amended and Restated Certificate of Incorporation of the Registrant (formerly, Galena Biopharma, Inc.) amended as of December 27, 2017

10-K

3.1

April 13, 2018

3.2

Amended and Restated By-Laws of the Registrant

8-K

3.3

January 5, 2018

3.2

Amended and Restated By-Laws of the Registrant

8-K

3.3

January 5, 2018

10.1

2021 Employee Stock Purchase Plan * **

4.1

Form of Warrant

8-K

4.1

April 1, 2022

31.1

Certification of Principal Executive Officer pursuant to Rule13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act, as amended.**

31.1

Certification of Principal Executive Officer pursuant to Rule13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act, as amended.**

31.2

Certification of Principal Financial Officer pursuant to Rule13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act, as amended.**

31.2

Certification of Principal Financial Officer pursuant to Rule13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act, as amended.**

32.1

Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. ***

32.1

Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. ***

101.INS

XBRL Instance Document.*

101.INS

XBRL Instance Document.*

101.SCH

XBRL Taxonomy Extension Schema.*

101.SCH

XBRL Taxonomy Extension Schema.*

101.CAL

XBRL Taxonomy Extension Calculation Linkbase.*

101.CAL

XBRL Taxonomy Extension Calculation Linkbase.*

101.DEF

XBRL Taxonomy Extension Definition Linkbase.*

101.DEF

XBRL Taxonomy Extension Definition Linkbase.*

101.LAB

XBRL Taxonomy Extension Label Linkbase.*

101.LAB

XBRL Taxonomy Extension Label Linkbase.*

101.PRE

XBRL Taxonomy Extension Presentation Linkbase.*

101.PRE

XBRL Taxonomy Extension Presentation Linkbase.*


*			Indicates management contract or compensatory plans or arrangements.
**			Filed herewith
***			The certification attached as Exhibit 32.1 accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

3335

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.


			SELLAS Life Sciences Group, Inc.

			By:						/s/ Angelos M. Stergiou

									Angelos M. Stergiou, MD, ScD h.c.
									President and Chief Executive Officer

									Date: August ~~12, 2021~~11, 2022

3436


As of June 30, 2021

Warrant Issuance	Outstanding (in thousands)	Strike price (per share)		Expected term (years)	Volatility %		Risk-free rate %
Other warrants (liability-classified)	13	$	7.50	2.26	151.45	%	0.30	%






As of December 31, 2020
Warrant Issuance	Outstanding (in thousands)	Strike price (per share)		Expected term (years)	Volatility %		Risk-free rate %
Other warrants (liability-classified)	13	$	7.50	2.75	150.38	%	0.16	%


Warrant Issuance	Warrant liability, December 31, 2020		Change in fair value of warrants		Warrant liability, June 30, 2021
Other warrants (liability-classified)	$	55	$	59	$	114






	$	55	$	59	$	114


	December 31, 2020		Additions		Revenue Recognized		June 30, 2021
Deferred revenue	$	5,600	$	2,000	$	(7,600)	$	0


	Shares (In Thousands)	Weighted Average Grant Date Fair Value
Unvested at December 31, 2020	170	$	1.89
Granted	40	$	8.00
Vested	0	$	0
Unvested at June 30, 2021	210	$	3.06