MUSTANG BIO, INC. [MBIO] Filings

10-Q 1 tmb-20220930x10q.htm 10-Q

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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 September 30, 2022

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

For the transition period from to

Commission File Number 001-38191

MUSTANG BIO, INC.

(Exact name of registrant as specified in its charter)

Delaware		47-3828760
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

377 Plantation Street

Worcester, MA 01605

(Address including zip code of principal executive offices)

(781) 652-4500

(Registrant’s telephone number, including area code)

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, par value $0.0001 per share	MBIO	NASDAQ Global Market

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

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

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

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

Class of Common Stock		Outstanding Shares as of November 11, 2022
Class A Common Stock, $0.0001 par value		845,385
Common Stock, $0.0001 par value		106,458,821

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MUSTANG BIO, INC.

QUARTERLY REPORT ON FORM 10-Q

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PART I. FINANCIAL INFORMATION		5

Item 1.	Unaudited Financial Statements	5

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	22

Item 3.	Quantitative and Qualitative Disclosures About Market Risks	29

Item 4.	Controls and Procedures	30

PART II. OTHER INFORMATION		30

Item 1.	Legal Proceedings	30

Item 1A	Risk Factors	30

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	72

Item 3.	Defaults Upon Senior Securities	72

Item 4.	Mine Safety Disclosures	72

Item 5.	Other Information	72

Item 6.	Exhibits	73

Signatures		74

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SUMMARY OF RISK FACTORS

Our business is subject to risks of which you should be aware before making an investment decision. The risks described below are a summary of the principal risks associated with an investment in us and are not the only risks we face. You should carefully consider these risk factors, the risk factors described in Item 1A, and the other reports and documents that we have filed with the Securities and Exchange Commission (“SEC”).

Risks Related to our Finances and Capital Requirements

●

We have incurred significant losses since our inception and anticipate that we will incur continued losses for the foreseeable future. We have not generated any revenue from our development stage products, and we do not know when, or if, we will generate any revenue.

●

Our short operating history makes it difficult to evaluate our business and prospects.

●

Our success is contingent upon raising additional capital, which efforts may fail. Even if successful, our future capital raising activities may dilute our current stockholders, restrict our operations, or cause us to relinquish proprietary rights.

Risks Pertaining to our Business Strategy, Structure and Organization

●

Our future growth and success depend on our ability to successfully develop and commercialize our product candidates, which we have yet to do.

●

Our growth and success depend on our acquiring or in-licensing products or product candidates and integrating such products into our business, and we may have limited growth opportunities if we fail to do so.

●

Our future success is highly dependent on the successful development of our chimeric antigen receptor (“CAR”) engineered T cell (“CAR T”) and gene therapy technology and product candidates.

Risks Inherent in Drug Development and Commercialization

●

Preclinical development is highly speculative and carries a high failure risk.

●

We may not receive the required regulatory approvals for any of our product candidates on our projected timelines, if at all, which may result in increased costs and delay our ability to generate revenue.

●

We may not obtain the desired labeling claims or intended uses for product promotion, or favorable scheduling classifications, to successfully promote our products.

●

If a product candidate demonstrates adverse side effects, we may need to abandon or limit the development of such product candidate.

●

Even if a product candidate is approved, it may be subject to various post-marketing requirements, including studies or clinical trials, and increased regulatory scrutiny.

●

Our competitors may develop treatments for our products’ target indications, which could limit our product candidates’ commercial opportunity and profitability.

●

If our products are not broadly accepted by the healthcare community, the revenues from any such product will likely be limited.

●

Any successful products liability claim related to any of our current or future product candidates may cause us to incur substantial liability and limit the commercialization of such products.

●

Our gene therapy product candidates are based on a novel technology, which makes it difficult to predict the time and cost of product candidate development and subsequently obtaining regulatory approval.

Risks Related to Reliance on Third Parties

●

We rely, and expect to continue to rely, on third parties to conduct our preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials or complying with applicable regulatory requirements.

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●

We contract with third parties for the manufacture of our product candidates for preclinical and clinical testing and may also do so for commercialization, if and when our product candidates are approved.

●

We rely on clinical data and results obtained by third parties, which may prove inaccurate or unreliable.

●

We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.

Risks Relating to Legislation and Regulation Affecting the Biopharmaceutical and Other Industries

●

We operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations.

●

We may be subject to anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

●

We are subject to numerous environmental, health and safety laws and regulations and could become subject to fines or penalties or incur costs that could harm our business.

Risks Pertaining to Intellectual Property and Potential Disputes with Licensors Thereof

●

If we are unable to maintain sufficient patent protection for our technology and products, our competitors could develop and commercialize products similar or identical to ours and our ability to successfully commercialize our technology and products could be impaired.

●

We depend on our licensors to maintain and enforce the intellectual property covering certain of our product candidates.

●

We or our licensors may be subject to costly and time-consuming litigation for infringement of third-party intellectual property rights or to enforce our or our licensors’ patents.

●

Any dispute with our licensors may affect our ability to develop or commercialize our product candidates.

Risks Relating to Our Control by Fortress Biotech, Inc. (“Fortress”)

●

Fortress controls a voting majority of our common stock and has the right to receive significant share grants annually, which will result in dilution of our other stockholders and could reduce the value of our common stock.

●

We have entered into certain agreements with Fortress and may have received better terms from unaffiliated third parties.

Risks Related to Conflicts of Interest

●

We share certain directors with Fortress, which could create conflicts of interest between us and Fortress.

General Risks

●

We have received notice from the Nasdaq Stock Market of non-compliance with its minimum bid price rules; our common stock may be subject to delisting from The Nasdaq Global Market if we are unable to regain compliance which may decrease the market liquidity and market price of our common stock.

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PART I. FINANCIAL INFORMATION

Item 1. Unaudited Financial Statements

MUSTANG BIO, INC.

Balance Sheets (Unaudited)

(in thousands, except share and per share amounts)


	September 30,		December 31,
	2022		2021

ASSETS
Current Assets:
Cash and cash equivalents	$	91,364	$	109,618
Other receivables - related party		33		50
Prepaid expenses and other current assets		3,050		2,038
Total current assets		94,447		111,706

Property, plant and equipment, net		8,950		9,025
Fixed assets - construction in process		1,095		2,027
Restricted cash		1,000		1,000
Other assets		320		362
Operating lease right-of-use asset, net		3,024		1,050
Total Assets	$	108,836	$	125,170

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable and accrued expenses	$	12,810	$	9,744
Payables and accrued expenses - related party		152		723
Operating lease liabilities - short-term		595		348
Total current liabilities		13,557		10,815

Deferred income		270		270
Note payable, long-term, net		27,293		—
Operating lease liabilities - long-term		3,391		1,685
Total Liabilities		44,511		12,770

Commitments and Contingencies (Note 11)

Stockholders’ Equity
Preferred stock ($0.0001 par value), 2,000,000 shares authorized, 250,000 shares of Class A preferred stock issued and outstanding as of September 30, 2022 and December 31, 2021, respectively		—		—
Common stock ($0.0001 par value), 200,000,000 and 150,000,000 shares authorized as of September 30, 2022 and December 31, 2021, respectively
Class A common shares, 845,385 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively		—		—
Common shares, 106,427,767 and 93,582,991 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively		11		9
Common stock issuable, 6,987 and 2,536,607 shares as of September 30, 2022 and December 31, 2021, respectively		4		4,329
Additional paid-in capital		374,045		359,906
Accumulated deficit		(309,735)		(251,844)
Total Stockholders’ Equity		64,325		112,400
Total Liabilities and Stockholders’ Equity	$	108,836	$	125,170

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

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MUSTANG BIO, INC.

Statements of Operations (Unaudited)

(in thousands, except share and per share amounts)


	For the three months ended September 30,				For the nine months ended September 30,
	2022		2021		2022		2021
Operating expenses:
Research and development	$	15,419	$	14,083	$	46,872	$	36,603
Research and development – licenses acquired		40		630		40		1,630
General and administrative		3,389		2,364		9,815		8,371
Total operating expenses		18,848		17,077		56,727		46,604
Loss from operations		(18,848)		(17,077)		(56,727)		(46,604)

Other income (expense)
Grant income		669		—		669		—
Interest income		216		75		366		294
Interest expense		(1,034)		(3)		(2,199)		(11)
Total other income (expense)		(149)		72		(1,164)		283
Net Loss	$	(18,997)	$	(17,005)	$	(57,891)	$	(46,321)

Net loss per common share outstanding, basic and diluted	$	(0.18)	$	(0.19)	$	(0.57)	$	(0.54)

Weighted average number of common shares outstanding, basic and diluted		105,917,723		91,136,969		102,289,247		86,487,092

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

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MUSTANG BIO, INC.

Statements of Stockholders’ Equity (Unaudited)

(in thousands, except share amounts)


	For the Three Months Ended September 30, 2022
										Common		Additional				Total
	Class A Preferred Stock			Class A Common Shares			Common Shares			Stock		Paid-in		Accumulated		Stockholders'
	Shares	Amount		Shares	Amount		Shares	Amount		Issuable		Capital		Deficit		Equity
Balances at June 30, 2022	250,000	$	—	845,385	$	—	104,511,195	$	10	$	28	$	372,708	$	(290,738)	$	82,008
Issuance of common shares, net of offering costs - At-the-Market Offering	—		—	—		—	1,125,012		—		—		709		—		709
Issuance of common shares, equity fee on At-the-Market Offering	—		—	—		—	62,678		1		(24)		42		—		19
Issuance of common shares under ESPP	—		—	—		—	173,552		—		—		90		—		90
Stock-based compensation expenses	—		—	—		—	555,330		—		—		496		—		496
Net loss	—		—	—		—	—		—		—		—		(18,997)		(18,997)
Balances at September 30, 2022	250,000	$	—	845,385	$	—	106,427,767	$	11	$	4	$	374,045	$	(309,735)	$	64,325


	For the Nine Months Ended September 30, 2022
										Common		Additional				Total
	Class A Preferred Stock			Class A Common Shares			Common Shares			Stock		Paid-in		Accumulated		Stockholders'
	Shares	Amount		Shares	Amount		Shares	Amount		Issuable		Capital		Deficit		Equity
Balances at December 31, 2021	250,000	$	—	845,385	$	—	93,582,991	$	9	$	4,329	$	359,906	$	(251,844)	$	112,400
Issuance of common shares - Founders Agreement	—		—	—		—	2,536,607		—		(4,212)		4,212		—		—
Issuance of common shares, net of offering costs - At-the-Market Offering	—		—	—		—	7,878,095		2		—		6,498		—		6,500
Issuance of common shares, equity fee on At-the-Market Offering	—		—	—		—	241,260		—		(113)		279		—		166
Issuance of common shares under ESPP	—		—	—		—	330,833		—		—		206		—		206
Stock-based compensation expenses	—		—	—		—	903,054		—		—		1,810		—		1,810
Issuance of common shares - Equity fee on RWG debt	—		—	—		—	954,927		—		—		750		—		750
Issuance of warrants for RWG debt	—		—	—		—	—		—		—		384		—		384
Net loss	—		—	—		—	—		—		—		—		(57,891)		(57,891)
Balances at September 30, 2022	250,000	$	—	845,385	$	—	106,427,767	$	11	$	4	$	374,045	$	(309,735)	$	64,325

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	For the Three Months Ended September 30, 2021
										Common		Additional				Total
	Class A Preferred Stock			Class A Common Shares			Common Shares			Stock		Paid-in		Accumulated		Stockholders'
	Shares	Amount		Shares	Amount		Shares	Amount		Issuable		Capital		Deficit		Equity
Balances at June 30, 2021	250,000	$	—	845,385	$	—	89,936,162	$	9	$	185	$	349,621	$	(214,790)	$	135,025
Issuance of common shares, net of offering shares -At-the-Market Offering	—		—	—		—	1,050,328		—		—		3,084		—		3,084
Issuance of common shares - Equity fee on At-the-Market Offering	—		—	—		—	64,339		—		(148)		223		—		75
Issuance of common shares under ESPP	—		—	—		—	58,358		—		—		151		—		151
Stock-based compensation expenses	—		—	—		—	50,627		—		—		884		—		884
Net loss	—		—	—		—	—		—		—		—		(17,005)		(17,005)
Balances at September 30, 2021	250,000	$	—	845,385	$	—	91,159,814	$	9	$	37	$	353,963	$	(231,795)	$	122,214


	For the Nine Months Ended September 30, 2021
										Common		Additional				Total
	Class A Preferred Stock			Class A Common Shares			Common Shares			Stock		Paid-in		Accumulated		Stockholders'
	Shares	Amount		Shares	Amount		Shares	Amount		Issuable		Capital		Deficit		Equity
Balances at December 31, 2020	250,000	$	—	845,385	$	—	70,920,693	$	7	$	7,939	$	275,963	$	(185,474)	$	98,435
Issuance of common shares - Founders Agreement	—		—	—		—	2,001,490		—		(7,577)		7,577		—		—
Issuance of common shares, net of offering shares -At-the-Market Offering	—		—	—		—	17,253,933		2		—		65,701		—		65,703
Issuance of common shares - Equity fee on At-the-Market Offering	—		—	—		—	517,304		—		(325)		1,986		—		1,661
Issuance of common shares under ESPP	—		—	—		—	114,321		—		—		309		—		309
Stock-based compensation expenses	—		—	—		—	351,935		—		—		2,427		—		2,427
Exercise of warrants	—		—	—		—	138		—		—		—		—		—
Net loss	—		—	—		—	—		—		—		—		(46,321)		(46,321)
Balances at September 30, 2021	250,000	$	—	845,385	$	—	91,159,814	$	9	$	37	$	353,963	$	(231,795)	$	122,214

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

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MUSTANG BIO, INC.

Statements of Cash Flows (Unaudited)

(in thousands)


	For the nine months ended September 30,
	2022		2021
Cash Flows from Operating Activities:
Net loss	$	(57,891)	$	(46,321)
Adjustments to reconcile net loss to net cash used in operating activities:
Issuance of common shares - Equity fee on at-the-market offering to Fortress Biotech		165		1,661
Research and development - licenses acquired		40		1,630
Issuance of common shares - Equity fee to Fortress Biotech on note payable		750		—
Stock-based compensation expenses		1,810		2,427
Depreciation expense		1,995		1,512
Amortization of debt discount		328		—
Amortization of operating lease right-of-use assets		202		102
Loss on disposal of property and equipment		255		—
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(970)		717
Other receivables - related party		17		(26)
Accounts payable and accrued expenses		4,316		(525)
Payable and accrued expenses - related party		(571)		(194)
Deferred income		—		270
Lease liabilities		(223)		(217)
Net cash used in operating activities		(49,777)		(38,964)

Cash Flows from Investing Activities:
Purchase of research and development licenses		(40)		(1,280)
Proceeds from the sale of fixed assets		127		—
Purchase of fixed assets		(2,619)		(2,609)
Net cash used in investing activities		(2,532)		(3,889)

Cash Flows from Financing Activities:
Proceeds from issuance of common shares - at-the-market offering		6,622		66,912
Offering costs for the issuance of common shares - at-the-market offering		(123)		(1,293)
Proceeds from debt issuance		30,000		—
Fees paid on the issuance of debt		(2,650)		—
Proceeds from issuance of common shares under ESPP		206		309
Net cash provided by financing activities		34,055		65,928

Net change in cash, cash equivalents and restricted cash		(18,254)		23,075
Cash, cash equivalents and restricted cash, beginning of the period		110,618		98,804
Cash, cash equivalents and restricted cash, end of the period	$	92,364	$	121,879

Supplemental disclosure of cash flow information:
Cash paid for interest	$	1,803	$	—

Supplemental disclosure of noncash activities:
Fixed assets (acquired but not paid)	$	21	$	1,376
Issuance of common shares - Founders Agreement	$	4,212	$	7,577
Research and development licenses included in accounts payable and accrued expenses	$	—	$	350
Note payable final payment fee (incurred but not paid)	$	1,050	$	—
Issuance of warrants - note payable	$	384	$	—
Lease liabilities arising from obtaining right-of-use assets	$	2,176	$	81

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

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MUSTANG BIO, INC.

Notes to Unaudited Financial Statements

Note 1 - Organization, Description of Business and Liquidity and Capital Resources

Mustang Bio, Inc. (the “Company” or “Mustang”) was incorporated in Delaware on March 13, 2015. Mustang is a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapy into potential cures for hematologic cancers, solid tumors and rare genetic diseases. The Company may acquire rights to these technologies by licensing the rights or otherwise acquiring an ownership interest in the technologies, funding their research and development and eventually either out-licensing or bringing the technologies to market.

The Company is a majority-controlled subsidiary of Fortress Biotech, Inc. (“Fortress” or “Parent”).

The Company’s common stock is listed on the NASDAQ Global Market and trades under the symbol “MBIO.”

Liquidity and Capital Resources

The Company has incurred substantial operating losses and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of September 30, 2022, the Company had an accumulated deficit of $309.7 million.

The Company has funded its operations to date primarily through the sale of equity and via debt raises, including its loan and financing agreement with Runway Growth Finance Corp. (the “Lender”), herein referred to as the (“Term Loan”). The Company expects to continue to use the proceeds from previous financing transactions primarily for general corporate purposes, including financing the Company’s growth, developing new or existing product candidates, and funding capital expenditures, acquisitions and investments. The Company currently anticipates that its cash and cash equivalents balances at September 30, 2022, are sufficient to fund its anticipated operating cash requirements for at least one year from the filing date of this Form 10-Q.

The Company will be required to expend significant funds in order to advance the development of its product candidates. The Company will require additional financings through equity and debt offerings, collaborations and licensing arrangements or other sources to fully develop, prepare regulatory filings, obtain regulatory approvals and commercialize its existing and any new product candidates. The rising interest rate environment may cause the Company to pay more interest on the Term Loan, which could lead to higher operating expenses.

In addition to the foregoing, the Company has experienced a moderate impact on its long-term development timeline and its liquidity due to the worldwide spread of the COVID-19 virus. The Company has experienced some delays in clinical trial activities, as well as in the availability and delivery of certain consumables and raw materials used in its laboratory and manufacturing operations due to the negative impact of COVID-19 on the global supply chain.

Note 2 - Significant Accounting Policies

Basis of Presentation

The accompanying interim unaudited financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X of the Exchange Act. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the interim unaudited financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. They do not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these financial statements should be read in conjunction with the Company's audited financial statements and notes thereto for the year ended December 31, 2021, which were included in the Company’s Form 10-K and filed with the SEC on March 23, 2022. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period.

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Use of Estimates

The Company’s unaudited financial statements include certain amounts that are based on management’s best estimates and judgments. The Company’s significant estimates include, but are not limited to, assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Due to the uncertainty inherent in such estimates, actual results could differ from those estimates.

Cash, Cash Equivalents and Restricted Cash

The Company records cash held in an escrow account as a security deposit for the manufacturing facility in Worcester, Massachusetts, as restricted cash.

The following table provides a reconciliation of cash, cash equivalents, and restricted cash from the Unaudited Balance Sheets to the Unaudited Statements of Cash Flows for the nine months ended September 30, 2022 and 2021:


	September 30,
($ in thousands)	2022	2021
Cash and cash equivalents	$ 91,364	$ 120,879
Restricted cash	1,000	1,000
Total cash, cash equivalents and restricted cash	$ 92,364	$ 121,879

Significant Accounting Policies

There have been no material changes to the Company’s significant accounting policies previously disclosed in the Company’s Form 10-K filed with the SEC on March 23, 2022.

Recently Issued Accounting Standards

In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption will be permitted. The Company is currently evaluating the impact of this standard on its financial statements.

In June 2016, FASB issued ASU 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments”. ASU 2016-13 requires that expected credit losses relating to financial assets are measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. ASU 2016-13 limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. Recently, the FASB issued the final ASU to delay adoption for smaller reporting companies to calendar year 2023. The Company is currently assessing the impact of the adoption of this ASU on its financial statements.

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Note 3 - Clinical Trial and Sponsored Research Agreements

Research and Development Expenses – All Licenses

City of Hope

CD123 License (MB-102)

For the three and nine months ended, September 30, 2021, the Company recorded $0.3 million related to a non-refundable milestone payment for the 24th patient treated in connection with the CD123 clinical study. There were no such expenses for the three and nine months ended September 30, 2022.

PSCA License (MB-105)

For the three and nine months ended, September 30, 2021, the Company expensed a non-refundable milestone payment of $0.3 million for the 12th patient treated in the Phase 1 clinical study of MB-105 at COH. There were no such expenses for the three and nine months ended September 30, 2022.

Leiden University Medical Centre License

For the three and nine months ended September 30, 2021, the Company expensed an upfront payment of $0.4 million in connection with an exclusive, worldwide licensing agreement with Leiden University Medical Centre for the use of a gene therapy under development for the treatment of severe immunodeficiency caused by RAG1 deficiency. There were no such expenses for the three and nine months ended September 30, 2022.

Mayo Clinic – CAR T Technology License

For the nine months ended September 30, 2021, the Company expensed an upfront payment of $0.8 million in connection with the exclusive license agreement with Mayo Clinic. There were no such expenses for the three and nine months ended September 30, 2022.

Research and Development Expenses - Sponsored Research and Clinical Trial Agreements

For the three and nine months ended September 30, 2022 and 2021, the Company recorded the following expense in research and development for sponsored research and clinical trial agreements in the Unaudited Statements of Operations pursuant to the terms of this agreement:


	For the three months ended September 30,				For the nine months ended September 30,
($ in thousands)	2022		2021		2022		2021
City of Hope National Medical Center	$	—	$	—	$	—	$	—
CD123		62		24		165		250
IL13Rα2		192		199		654		992
CS1		187		138		287		510
HER2		691		319		1,233		473
PSCA		27		23		77		69
Fred Hutchinson Cancer Center - CD20		132		492		978		1,490
St. Jude Children's Research Hospital - XSCID		184		330		402		610
LUMC - RAG1 SCID		92		—		357		—
Mayo Clinic