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Table of Contents

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, 2022

OR

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

For the transition period from            to

Commission File Number 001-38191

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 August 9, 2022

Class A Common Stock, $0.0001 par value

 

845,385

Common Stock, $0.0001 par value

 

105,221,651

Table of Contents

MUSTANG BIO, INC.

QUARTERLY REPORT ON FORM 10-Q

TABLE OF CONTENTS

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

21

Item 3.

Quantitative and Qualitative Disclosures About Market Risks

28

Item 4.

Controls and Procedures

28

PART II. OTHER INFORMATION

29

Item 1.

Legal Proceedings

29

Item 1A

Risk Factors

29

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

70

Item 3.

Defaults Upon Senior Securities

70

Item 4.

Mine Safety Disclosures

70

Item 5.

Other Information

70

Item 6.

Exhibits

71

Signatures

72

2

Table of Contents

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)

June 30, 

December 31, 

    

2022

    

2021

ASSETS

 

  

 

  

Current Assets:

 

  

 

  

Cash and cash equivalents

$

107,369

$

109,618

Other receivables - related party

 

33

 

50

Prepaid expenses and other current assets

 

1,974

 

2,038

Total current assets

 

109,376

 

111,706

 

  

 

  

Property, plant and equipment, net

 

8,663

 

9,025

Fixed assets - construction in process

 

1,537

 

2,027

Restricted cash

 

1,000

 

1,000

Other assets

 

359

 

362

Operating lease right-of-use asset, net

970

1,050

Total Assets

$

121,905

$

125,170

 

  

 

  

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

  

 

  

Current Liabilities:

 

  

 

  

Accounts payable and accrued expenses

$

10,165

$

9,744

Payables and accrued expenses - related party

448

723

Operating lease liabilities - short-term

368

348

Total current liabilities

 

10,981

 

10,815

 

  

 

  

Deferred income

 

270

 

270

Note payable, long-term, net

 

27,150

 

Operating lease liabilities - long-term

1,496

1,685

Total Liabilities

 

39,897

 

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 June 30, 2022 and December 31, 2021, respectively

 

 

Common stock ($0.0001 par value), 200,000,000 and 150,000,000 shares authorized as of June 30, 2022 and December 31, 2021, respectively

 

  

 

  

Class A common shares, 845,385 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

 

 

Common shares, 104,511,195 and 93,582,991 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

 

10

 

9

Common stock issuable, 41,652 and 2,536,607 shares as of June 30, 2022 and December 31, 2021, respectively

 

28

 

4,329

Additional paid-in capital

 

372,708

 

359,906

Accumulated deficit

 

(290,738)

 

(251,844)

Total Stockholders’ Equity

 

82,008

 

112,400

Total Liabilities and Stockholders’ Equity

$

121,905

$

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 June 30, 

For the six months ended June 30, 

    

2022

    

2021

    

2022

    

2021

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

$

15,164

$

10,902

$

31,453

$

22,520

Research and development – licenses acquired

 

 

1,000

 

 

1,000

General and administrative

 

3,077

 

2,538

 

6,426

 

6,007

Total operating expenses

 

18,241

 

14,440

 

37,879

 

29,527

Loss from operations

 

(18,241)

 

(14,440)

 

(37,879)

 

(29,527)

 

  

 

  

 

  

 

  

Other income (expense)

 

  

 

  

 

  

 

  

Interest income

 

77

 

85

 

150

 

219

Interest expense

 

(935)

 

(4)

 

(1,165)

 

(8)

Total other income (expense)

 

(858)

 

81

 

(1,015)

 

211

Net Loss

$

(19,099)

$

(14,359)

$

(38,894)

$

(29,316)

 

 

  

 

 

  

Net loss per common share outstanding, basic and diluted

$

(0.19)

$

(0.16)

$

(0.39)

$

(0.35)

 

  

 

  

 

  

 

  

Weighted average number of common shares outstanding, basic and diluted

 

102,947,158

 

87,561,764

 

100,444,938

 

84,033,508

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 June 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 March 31, 2022

 

250,000

$

 

845,385

$

 

100,287,838

$

10

$

27

$

368,933

$

(271,639)

$

97,331

Issuance of common shares, net of offering costs - At-the-Market Offering

 

 

 

 

 

3,979,289

 

 

 

3,051

 

 

3,051

Issuance of common shares, equity fee on At-the-Market Offering

 

 

 

 

 

84,207

 

 

1

 

74

 

 

75

Issuance of common shares under ESPP

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expenses

 

 

 

 

 

159,861

 

 

 

650

 

 

650

Net loss

 

 

 

 

 

 

 

 

 

(19,099)

 

(19,099)

Balances at June 30, 2022

 

250,000

$

 

845,385

$

 

104,511,195

$

10

$

28

$

372,708

$

(290,738)

$

82,008

For the Six Months Ended June 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

 

 

 

 

 

6,753,083

 

1

 

 

5,789

 

 

5,790

Issuance of common shares, equity fee on At-the-Market Offering

 

 

 

 

 

178,582

 

 

(89)

 

237

 

 

148

Issuance of common shares under ESPP

 

 

 

 

 

157,281

 

 

 

116

 

 

116

Stock-based compensation expenses

 

 

 

 

 

347,724

 

 

 

1,314

 

 

1,314

Issuance of common shares - Equity fee on RWG debt

 

 

 

954,927

750

750

Issuance of warrants for RWG debt

 

 

 

384

384

Exercise of warrants

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

(38,894)

 

(38,894)

Balances at June 30, 2022

 

250,000

$

 

845,385

$

 

104,511,195

$

10

$

28

$

372,708

$

(290,738)

$

82,008

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For the Three Months Ended June 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 March 31, 2021

 

250,000

$

 

845,385

$

 

85,043,153

$

8

$

218

$

333,566

$

(200,431)

$

133,361

Issuance of common shares, net of offering shares -At-the-Market Offering

4,606,102

1

15,087

15,088

Issuance of common shares - Equity fee on At-the-Market Offering

127,744

(33)

421

388

Issuance of common shares under ESPP

1,043

Stock-based compensation expenses

 

 

 

 

 

158,120

 

 

547

 

 

547

Net loss

 

 

 

 

 

 

 

 

(14,359)

 

(14,359)

Balances at June 30, 2021

 

250,000

$

 

845,385

$

 

89,936,162

$

9

$

185

$

349,621

$

(214,790)

$

135,025

For the Six Months Ended June 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

16,203,605

2

62,617

62,619

Issuance of common shares - Equity fee on At-the-Market Offering

452,965

(177)

1,763

1,586

Issuance of common shares under ESPP

55,963

158

158

Stock-based compensation expenses

301,308

1,543

1,543

Exercise of warrants

 

 

 

 

 

138

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

(29,316)

 

(29,316)

Balances at June 30, 2021

 

250,000

$

 

845,385

$

 

89,936,162

$

9

$

185

$

349,621

$

(214,790)

$

135,025

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 six months ended June 30, 

    

2022

    

2021

Cash Flows from Operating Activities:

 

  

 

  

Net loss

$

(38,894)

$

(29,316)

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

 

147

 

1,586

Common shares issuable for Founders Agreement

1

Research and development - licenses acquired

1,000

Issuance of common shares - Equity fee to Fortress Biotech on note payable

750

Stock-based compensation expenses

 

1,314

 

1,543

Depreciation expense

 

1,298

 

934

Amortization of debt discount

185

Amortization of operating lease right-of-use assets

 

80

 

68

Loss on disposal of property and equipment

239

Changes in operating assets and liabilities:

 

 

  

Prepaid expenses and other assets

 

67

 

324

Other receivables - related party

17

(17)

Accounts payable and accrued expenses

 

1,376

 

(3,414)

Payable and accrued expenses - related party

 

(275)

 

(241)

Lease liabilities

(169)

(142)

Net cash used in operating activities

 

(33,864)

 

(27,675)

 

  

 

  

Cash Flows from Investing Activities:

 

  

 

  

Purchase of research and development licenses

 

 

(750)

Purchase of fixed assets

 

(1,640)

 

(2,149)

Net cash used in investing activities

 

(1,640)

 

(2,899)

 

  

 

  

Cash Flows from Financing Activities:

 

  

 

  

Proceeds from issuance of common shares - at-the-market offering

5,900

63,773

Offering costs for the issuance of common shares - at-the-market offering

(110)

(1,238)

Proceeds from debt issuance

30,000

Fees paid on the issuance of debt

(2,651)

Proceeds from issuance of common shares under ESPP

116

158

Net cash provided by financing activities

 

33,255

 

62,693

 

  

 

  

Net change in cash, cash equivalents and restricted cash

 

(2,249)

 

32,119

Cash, cash equivalents and restricted cash, beginning of the period

 

110,618

 

98,804

Cash, cash equivalents and restricted cash, end of the period

$

108,369

$

130,923

 

  

 

  

Supplemental disclosure of cash flow information:

 

  

 

  

Cash paid for interest

$

845

$

 

  

 

  

Supplemental disclosure of noncash investing and financing activities:

 

  

 

  

Fixed assets (acquired but not paid)

$

315

$

298

Issuance of common shares - Founders Agreement

$

4,212

$

7,577

Research and development licenses included in accounts payable and accrued expenses

$

$

250

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

$

$

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 June 30, 2022, the Company had an accumulated deficit of $290.7 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 June 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.

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 six months ended June 30, 2022 and 2021:

June 30,

($ in thousands)

2022

2021

Cash and cash equivalents

$ 107,369

$ 129,923

Restricted cash

1,000

1,000

Total cash, cash equivalents and restricted cash

$ 108,369

$ 130,923

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 six months ended, June 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 six months ended June 30, 2022.

Mayo Clinic – CAR T Technology License

For the three and six months ended June 30, 2021, the Company recorded $0.8 million in research and development expenses – licenses acquired. There were no such expenses for the three and six months ended June 30, 2022.

Research and Development Expenses - Sponsored Research and Clinical Trial Agreements

For the three and six months ended June 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 June 30, 

For the six months ended June 30, 

($ in thousands)

    

2022

    

2021

    

2022

    

2021

City of Hope National Medical Center

$

$

$

$

CD123

52

21

103

226

IL13Rα2

234

279

462

793

CS1

50

197

100

372

HER2

271

31

542

154

PSCA

28

(4)

50

46

Fred Hutchinson Cancer Research Center - CD20

358

327

846

998

St. Jude Children's Research Hospital - XSCID

94

176

218

280

LUMC - RAG1 SCID

138

265

Mayo Clinic

231

233

462

233

Total

$

1,456

$

1,260

$

3,048

$

3,102

CD123 (MB-102) Clinical Research Support Agreement

Since February 2017, the Company has been party to a clinical research support agreement for the CD123-directed CAR T program (the “CD123 CRA”) with COH whereby, the Company has agreed to contribute approximately $0.1 million per patient in connection with the ongoing investigator-initiated study.

IL13Rα2 (MB-101) Clinical Research Support Agreements

Since February 2017, the Company has been party to a clinical research support agreement for the IL13Rα2-directed CAR T program (the “IL13Rα2 CRA”) with COH whereby, the Company has agreed to contribute $0.1 million related to patient costs in connection with the on-going investigator-initiated study.

Since October 2020, the Company has been party to a clinical research support agreement for the IL13Rα2-directed CAR T program for adult patients with leptomeningeal glioblastoma, ependymoma or medulloblastoma (the “IL13Rα2 Leptomeningeal CRA”) with COH whereby, the Company has agreed to contribute $0.1 million per patient in connection

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with the ongoing investigator-initiated study. Further, the Company agreed to fund approximately $0.2 million annually pertaining to the clinical development of the IL13Rα2-directed CAR T program for this patient population.

Since March 2021, the Company has been party to a clinical research support agreement for an Institutional Review Board-approved, investigator-initiated protocol entitled: “Single Patient Treatment with Intraventricular Infusions of IL13Rα2-targeting and HER2-targeting Chimeric Antigen Receptor (CAR)-T cells for a Single Patient (UPN 181) with Recurrent Multifocal Malignant Glioma.” Pursuant to the terms of this agreement, the Company will contribute up to $0.2 million in connection with the ongoing investigator-initiated study.

CS1 (MB-104) Clinical Research  Support Agreement

Since June 2020, the Company has been party to a clinical research and support agreement with COH in connection with an investigator-sponsored study conducted under an Institutional Review Board-approved for MB-104 whereby, the Company has agreed to reimburse COH for costs associated with this trial, when incurred, not to exceed $2.4 million. The agreement will expire upon the delivery of a final study report or earlier. Since inception, the Company has reimbursed COH $1.5 million.

HER2 (MB-103) Clinical Research Support Agreement

Since September 2020, the Company has been party to a clinical research support agreement with COH in connection with an investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled: “Phase I Study of Cellular Immunotherapy using Memory-Enriched T Cells Lentivirally Transduced to Express a HER2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients with Recurrent/Refractory Malignant Glioma” for MB-103. Under the terms of the agreement the Company will reimburse COH for costs associated with this trial not to exceed $3.0 million. The agreement will expire upon the delivery of a final study report or earlier. Since inception, the Company has reimbursed COH $2.5 million.

PSCA (MB-105) Clinical Research Support Agreement

Since October 2020, the Company has been party to a clinical research support agreement with COH in connection with an investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled: “A Phase 1 Study to Evaluate PSCA-Specific Chimeric Antigen Receptor (CAR)-T Cells for Patients with Metastatic Castration Resistant Prostate Cancer” for MB-105. The Company has agreed to reimburse COH for costs associated with this trial not to exceed $2.3 million.  The agreement will expire upon the delivery of a final study report or earlier. Since inception, the Company has reimbursed COH $0.3 million.

CD20 (MB-106) Clinical Trial Agreement with Fred Hutchinson Cancer Research Center

Since July 3, 2017, in conjunction with the CD20 Technology License from Fred Hutchinson Cancer Research Center (“Fred Hutch”), the Company has been party to an investigator-initiated clinical trial agreement (the “CD20 CTA”) to provide partial funding for a Phase 1/2 clinical trial at Fred Hutch evaluating the safety and efficacy of the CD20 Technology in patients with relapsed or refractory B-cell non-Hodgkin lymphomas. In connection with the CD20 CTA, the Company agreed to fund up to $5.3 million of costs associated with the clinical trial, which commenced during the fourth quarter of 2017. In November 2020, the CD20 CTA was amended to include additional funding of approximately $1.8 million, which includes $0.8 million for the treatment of five patients with chronic lymphocytic leukemia. In January 2022, the CD20 CTA was amended to include additional funding of $2.2 million increasing the total payment obligation of the Company in connection with the CD20 CTA not to exceed $9.3 m