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MUSTANG BIO INC

For the period ended Mar 31, 2024. Filed May 15, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2024 · Filed May 15, 2024

MBIO$0.45+15.1%Stored close · as of Nov 10, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

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Item 1. Unaudited Financial Statements

Balance Sheets** (Unaudited)**

(in thousands, except share and per share amounts)

​​​​​​​
​ · ​ · March 31, · ​ · December 31,
​ · 2024 · 2023
​ · ​ · ​ · ​ · ​
ASSETS · ​ · ​
Current Assets: · ​ · ​
Cash and cash equivalents​$1,337​$6,234
Other receivables​​6,738​​3,879
Prepaid expenses and other current assets​1,165​1,233
Total current assets​9,240​11,346
​​​
Property, plant and equipment, net​2,962​3,247
Restricted cash​375​750
Other assets​530​833
Operating lease right-of-use asset, net​​1,485​​1,566
Total Assets​$14,592​$17,742
​​​
LIABILITIES AND STOCKHOLDERS’ EQUITY​​
Current Liabilities:​​
Accounts payable and accrued expenses​$15,014​$14,017
Payables and accrued expenses - related party​​1,854​​834
Operating lease liabilities - short-term​​570​​520
Total current liabilities​17,438​15,371
​​​
Deferred income​270​270
Operating lease liabilities - long-term​​1,827​​1,978
Total Liabilities​19,535​17,619
​​​​
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 March 31, 2024 and December 31, 2023, respectively​—​—
Common stock ($0.0001 par value), 200,000,000 shares authorized as of March 31, 2024 and December 31, 2023, respectively​​
Class A common shares, 845,385 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively​—​—
Common shares, 9,545,541 and 8,374,869 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively​1​1
Common stock issuable, zero and 419,089 shares as of March 31, 2024 and December 31, 2023, respectively​—​591
Additional paid-in capital​381,218​380,502
Accumulated deficit​(386,162)​(380,971)
Total Stockholders’ Equity​(4,943)​123
Total Liabilities and Stockholders’ Equity​$14,592​$17,742

Statements of Operations** (Unaudited)**

(in thousands, except share and per share amounts)

​​​​​​​​
​ · ​ · For the three months ended March 31, · ​
​ · 2024 · 2023
Operating expenses: · ​ · ​
Research and development​$3,804​$14,000​
General and administrative​1,427​2,321​
Total operating expenses​5,231​16,321​
Loss from operations​(5,231)​(16,321)​
​​​​
Other income (expense)​​​
Other income​​—​​351​
Interest income​41​453​
Interest expense​(1)​(1,176)​
Total other income (expense)​40​(372)​
Net Loss​$(5,191)​$(16,693)​
​​​​​
Net loss per common share outstanding, basic and diluted​$(0.46)​$(2.06)​
​​​​
Weighted average number of common shares outstanding, basic and diluted​11,253,767​8,093,662​

Statements of Stockholders’ Equity (Unaudited)

(in thousands, except share amounts)

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · For the Three Months Ended March 31, 2024
​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · 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, 2023250,000​$—845,385​$—8,374,869​$1​$591​$380,502​$(380,971)​$123
Issuance of common shares - Founders Agreement—​——​—353,086​—​(477)​477​—​—
Issuance of common shares, equity fee on At-the-Market Offering—​——​—66,003​—​(114)​114​—​—
Issuance of common shares under ESPP—​——​—41,774​—​—​48​—​48
Stock-based compensation expenses—​——​—5,573​—​—​76​—​76
Exercise of warrants—​——​—704,236​—​—​1​—​1
Net loss—​——​——​—​—​—​(5,191)​(5,191)
Balances at March 31, 2024250,000​$—845,385​$—9,545,541​$1​$—​$381,218​$(386,162)​$(4,943)
​​​​​​​​​​​​​​​​​​​​​​​​​​​​
​ · ​ · For the Three Months Ended March 31, 2023
​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · Common · ​ · Additional · ​ · ​ · ​ · ​ · Total
​ · ​ · Class A Preferred Stock · ​ · Class A Common Shares · ​ · Common Shares · ​ · Stock · ​ · Paid-in · ​ · Accumulated · ​ · Stockholders'
​ · Shares · Amount · Shares · Amount · Shares · Amount · Issuable · Capital · Deficit · Equity
Balances at December 31, 2022250,000​$—845,385​$—7,100,111​$11​$1,109​$374,522​$(329,369)​$46,273
Issuance of common shares - Founders Agreement—​——​—187,134​—​(1,109)​1,109​—​—
Stock-based compensation expenses​—​​—​—​​—​5,905​​—​​—​​235​​—​​235
Exercise of warrants—​——​—92​—​—​—​—​—
Reverse Split (15:1) adjustment​—​——​——​(10)​—​10​—​—
Net loss—​——​——​—​—​—​(16,693)​(16,693)
Balances at March 31, 2023250,000​$—845,385​$—7,293,242​$1​$—​$375,876​$(346,062)​$29,815

Statements of Cash Flows** (Unaudited)**

(in thousands)

​​​​​​​
​ · ​ · For the three months ended March 31,
​ · 2024 · 2023
Cash Flows from Operating Activities: · ​ · ​
Net loss​$(5,191)​$(16,693)
Stock-based compensation expenses​76​235
Depreciation expense​285​752
Amortization of debt discount​​—​​143
Amortization of operating lease right-of-use assets​​411​​106
Changes in operating assets and liabilities:​​​​​
Prepaid expenses and other assets​371​131
Other receivables​​(2,859)​​—
Other receivables - related party​​—​​36
Accounts payable and accrued expenses​997​(2,311)
Payable and accrued expenses - related party​1,020​(165)
Lease liabilities​​(431)​​(42)
Net cash used in operating activities​(5,321)​(17,808)
​​​
Cash Flows from Investing Activities:​​
Net cash from investing activities​—​—
​​​
Cash Flows from Financing Activities:​​
Proceeds from exercise of warrants​​1​​—
Proceeds from issuance of common shares under ESPP​​48​​—
Net cash provided by financing activities​49​—
​​​
Net change in cash, cash equivalents and restricted cash​(5,272)​(17,808)
Cash, cash equivalents and restricted cash, beginning of the period​6,984​76,656
Cash, cash equivalents and restricted cash, end of the period​$1,712​$58,848
​​​​
Supplemental disclosure of cash flow information:​​​
Cash paid for interest​$—​$1,024
​​​
Supplemental disclosure of noncash activities:​​
Fixed assets (acquired but not paid)​$—​$18
Issuance of common shares - Founders Agreement​$477​$1,109

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

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 medical breakthroughs in cell and gene therapy into potential cures for hematologic cancers and solid tumors. 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”).

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 March 31, 2024, the Company had an accumulated deficit of $386.2 million.

The Company has funded its operations to date primarily through the sale of equity and via debt raises. The Company expects to continue to use the proceeds from its previous financing transactions and asset sale primarily for working capital and general corporate purposes.

The Company will require substantial 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 product candidates. The continuation of our business as a going concern is dependent upon raising additional capital and eventually attaining and maintaining profitable operations.

In accordance with Accounting Standards Codification (“ASC”) 205-40, 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 date that these unaudited consolidated financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that these unaudited consolidated financial statements are issued. In performing its evaluation, management excluded certain elements of its operating plan that cannot be considered probable. Under ASC 205-40, the future receipt of potential funding from future equity or debt issuances cannot be considered probable at this time because these plans are not entirely within the Company’s control nor have been approved by the Board of Directors as of the date of these financial statements.

The Company's expectation to generate operating losses and negative operating cash flows in the future, and the need for additional funding to support its planned operations raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date that these unaudited consolidated financial statements are issued. The Company made strategic decisions, including a significant reduction in the workforce by approximately 81% in April 2024, and terminated certain license agreements with St. Jude and Leiden University Medical Centre, also in April 2024 to preserve capital and prioritize the allocation of resources. The Company continues to pursue additional cash resources through public or private equity or debt financings. The Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of these unaudited financial statements.

The accompanying unaudited financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that may be necessary if the Company is unable to continue as a going concern.

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 under the Securities Exchange Act of 1934, as amended (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, 2023, which were included in the Company’s Annual Report on Form 10-K and filed with the Securities and Exchange Commission (“SEC”) on March 11, 2024 (the “2023 Form 10-K”). 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.

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 three months ended March 31, 2024, and 2023:

​​​​
​March 31,
($ in thousands)2024​2023
Cash and cash equivalents$ 1,337​$ 58,098
Restricted cash375​750
Total cash, cash equivalents and restricted cash$ 1,712​$ 58,848

Significant Accounting Policies

There have been no material changes to the Company’s significant accounting policies previously disclosed in the 2023 Form 10-K.

Recently Issued Accounting Standards

As of March 31, 2024, there were no new accounting pronouncements or updates to recently issued accounting pronouncements disclosed in the 2023 Form 10-K that affect the Company’s present or future results of operations, overall financial condition, liquidity, or disclosures upon adoption.

Note 3 - Clinical Trial and Sponsored Research Agreements

Research and Development Expenses - Sponsored Research and Clinical Trial Agreements

For the three months ended March 31, 2024 and 2023, the Company recorded the following expenses in research and development for sponsored research and clinical trial agreements in the Unaudited Statements of Operations pursuant to the terms of these agreements:

​​​​​​​​
​ · ​ · For the three months ended March 31, · ​
($ in thousands) · 2024 · 2023
City of Hope National Medical Center​​​​​​​
IL13Rα2​​280​​310​
CS1​​—​​50​
PSCA​​—​​22​
Fred Hutchinson Cancer Center - CD20​​—​​554​
St. Jude Children's Research Hospital - XSCID​​(434)​​419​
Leiden University Medical Center - RAG1 SCID​​120​​112​
Mayo Clinic​​—​​275​
Total​$(34)​$1,742​

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 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 October 2020, the Company has been party to a Sponsored Research Agreement (“SRA”) with COH to conduct combination studies of a potential IL13Rα2* *CAR (MB-101) and herpes simplex-1 oncolytic virus therapy (MB-108). Pursuant to the SRA, the Company funded research in the amount of $0.3 million for the program. In November 2022, the SRA was amended to include additional funding of $0.6 million.

CS1 (MB-104) Clinical Research Support Agreement

Beginning in June 2020, the Company was 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 $2.2 million. In May 2023, the Company determined to discontinue development of its MB-104 program and terminated the associated CRA and license.

PSCA (MB-105) Clinical Research Support Agreement

Beginning in October 2020, the Company was 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 $0.5 million. In May 2023, the Company determined to discontinue development of its MB-105 program and terminated the associated CRA and license.

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

Since July 3, 2017, in conjunction with the CD20 Technology License from Fred Hutchinson Cancer 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 million.

XSCID (MB-107) Data Transfer Agreement with St. Jude Children’s Research Hospital

Since June 2020, the Company has been party to a Data Transfer Agreement with St. Jude Children’s Research Hospital (“St. Jude”) under which Mustang will reimburse St. Jude for costs associated with St. Jude’s clinical trial for the treatment of infants with X-linked severe combined immunodeficiency (“XSCID”), whereby the Company will continue to reimburse St. Jude for costs incurred in connection with this trial. In April 2024, the Company terminated its license agreement and the associated Data Transfer Agreement with St. Jude, in exchange for a mutual release of liability and forgiveness by St. Jude of all amounts previously owed by the Company.

RAG1-SCID (MB-110) Sponsored Research Support Agreement (“SRA”) with Leiden University Medical Centre

Since September 8, 2021, in connection with the Leiden License, the Company has been party to a Sponsored Research Support Agreement (“SRA”) with Leiden University Medical Centre (“LUMC”) under which the Company will fund research in the amount of approximately $0.5 million annually over a period of 5 years. The research performed pursuant to this agreement will support technology the Company has licensed from Leiden for the use of a gene therapy under development for the treatment of severe immunodeficiency caused by mutations in theRAG1 gene. In April 2024, the Company delivered a termination notice to LUMC, pursuant to which it terminated the license agreement underpinning the MB-110 product candidate; the Company is currently in discussions with LUMC regarding the terms that will govern such termination.

Sponsored Research Support Agreement with Mayo Clinic

Since June 2021, the Company has been party to an SRA with the Mayo Clinic under which the Company will fund research in the amount of $2.1 million over a period oftwo years. In October 2022, the SRA was amended to include additional funding of approximately $0.1 million. The research performed pursuant to this agreement will support technology the Company has licensed from Mayo Clinic for a novel technology that may be able to transform the administration of CAR T therapies and has the potential to be used as an off-the-shelf therapy.

Note 4 - Related Party Agreements

Founders Agreement and Management Services Agreement with Fortress

With respect to the Company’s Management Services Agreement (the “Management Services Agreement”) with Fortress for the three months ended March 31, 2024 and 2023, expenses related to the MSA are recorded 50% in research and development expenses and 50% in general and administrative expenses in the Unaudited Statements of Operations. For the three months ended March 31, 2024 and 2023, the Company recorded expense of $0.1 million and $0.1 million, respectively, related to the MSA.

Under the terms of the Second Amended and Restated Founders Agreement (the “Founders Agreement”), which became effective July 22, 2016, Fortress will receive a grant of shares of the Company’s common stock equal to two and one-half percent (2.5%) of the gross amount of any equity or debt financing. For the three months ended March 31, 2024, and 2023, no equity or debt financing occurred, andno common stock was issuable to Fortress under the Founders Agreement.

Annual Stock Dividend

Pursuant to the Company’s Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), the Company issued 353,086 shares of common stock to Fortress as the Annual Stock Dividend (as such term is defined in the Certificate of Incorporation), representing 2.5% of the fully-diluted outstanding equity of Mustang on January 2, 2024. This was recorded in the Statement of Stockholders’ Equity at December 31, 2023, as Common stock issuable – Founders Agreement. The Company recorded an expense of approximately $0.5 million in research and development – licenses acquired related to these issuable shares during the year ended December 31, 2023.

Payables and Accrued Expenses Related Party

In the normal course of business Fortress pays for certain expenses on behalf of the Company. Such expenses are recorded as payables and accrued expenses - related party and are reimbursed to Fortress in the normal course of business.

Note 5 – Property, Plant and Equipment

At March 31, 2024, and December 31, 2023, property, plant and equipment consisted of the following:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · Estimated Useful · March 31, · December 31,
($ in thousands)​Life (in years)​2024​2023
Leasehold improvements9​7,694​7,694
Construction in processN/A​29​29
Total property, plant and equipment​​​7,723​7,723
Less: accumulated depreciation​​​(4,761)​(4,476)
Property, plant and equipment, net​​​$2,962​$3,247

Depreciation expense for the three months ended March 31, 2024 and 2023, was approximately $0.3 million and $0.8 million, respectively, and was recorded in research and development expense in the Unaudited Statements of Operations.

Note 6 - Accounts Payable and Accrued Expenses

At March 31, 2024, and December 31, 2023, accounts payable and accrued expenses consisted of the following:

​​​​​​​​
​ · ​ · March 31, · ​ · December 31, · ​
($ in thousands) · ​ · 2024 · 2023 · ​
Accounts payable​$11,279​$6,322​
Accrued research and development​​1,857​​4,118​
Accrued compensation​​1,201​​2,838​
Other​​677​​739​
Total accounts payable and accrued expenses​$15,014​$14,017​

Note 7 – Notes Payable

On April 11, 2023, the Company’s long-term debt facility (the “Term Loan”) with Runway Growth Finance Corp. (“Runway”) was terminated upon receipt by Runway of a payoff amount of $30.4 million from the Company comprised of principal, interest and the applicable final payment amount. For the three months ended March 31, 2024 and 2023, the Company recorded the following components in interest expense:

​​​​​​​
​ · ​ · For the three months ended March 31,
($ in thousands) · ​ · 2024 · 2023
Interest expense​$—​$1,055
Amortization of Debt Discount​​—​​117
Other​​1​​4
Total Interest Expense​$1​$1,176

The Company entered into the Term Loan on March 4, 2022. Under the Term Loan, $30.0 million of the $75.0 million loan was funded on the Closing Date, with the remaining $45.0 million fundable if the Company achieved certain predetermined milestones.

The Term Loan accrued interest at a variable annual rate equal to 8.75% plus the greater of (i)0.50% and (ii) the three month LIBOR Rate for U.S. dollar deposits or the rate otherwise reasonably determined by the Lender to be the rate at which U.S. dollar deposits with a term of three months would be offered by banks in London, England to major banks in the London or other offshore interbank market (the “Applicable Rate”); provided that the Applicable Rate would not be less than 9.25%. On December 7, 2022, the Company entered into the First Amendment (the “First Amendment”) to the Loan Agreement by and between the Company and Runway. The First Amendment amended certain definitions and other provisions of the Loan Agreement to replace LIBOR-based benchmark rates applicable to loans outstanding under the Loan Agreement with SOFR-based rates, subject to adjustments as specified in the First Amendment. The Applicable Rate at March 31, 2023 was 13.77%. For the three months ended March 31, 2023, the Company made interest payments of $1.0 million recorded in interest expense in the Unaudited Statements of Operations.

Amortization of the debt discount associated with the Term Loan was approximately $0.1 million for the three months ended March 31, 2023, and was recorded in interest expense in the Unaudited Statements of Operations.

In addition, the Term Loan was secured by a lien on substantially all of the Company’s assets other than certain intellectual property assets and certain other excluded collateral, and it contained a minimum liquidity covenant and other covenants that included among other items: (i) limits on indebtedness, and (ii) repurchase of stock from employees, officers and directors.

Note 8 - Stockholders’ Equity

Registration Statements

On April 23, 2021, the Company filed a shelf registration statement on Form S-3 (File No. 333-255476) (the “2021 S-3”), which was declared effective on May 24, 2021. Under the 2021 S-3, the Company may sell up to a total of $200.0 million of its securities. As of March 31, 2024, approximately $195.6 million of the 2021 S-3 remained available for sales of securities. The 2021 S-3 expires on May 24, 2024.

As of the filing of this Form 10-Q, the Company is subject to the General Instruction I.B.6 to Form S-3, known as the “baby shelf rules,” which limit the number of securities it can sell under its registration statements on Form S-3.

At-the-Market Offering

In July 2018, the Company entered into an At-the-Market Issuance Sales Agreement (the “Mustang ATM”) with B. Riley Securities, Inc. (formerly B. Riley FBR, Inc.), Cantor Fitzgerald & Co., National Securities Corporation (now B. Riley FBR, Inc.), and Oppenheimer & Co. Inc. (each an “Agent” and collectively, the “Agents”), relating to the sale of shares of common stock pursuant to the 2020 S-3. Under the Mustang ATM, the Company pays the Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock. On December 31, 2020, the Mustang ATM was amended to add H.C. Wainwright & Co., LLC as an Agent. On April 14, 2023, the Mustang ATM was amended to add the limitations imposed by General Instruction I.B.6 to Form S-3 and remove Oppenheimer & Co., Inc. as an Agent.

During the three months ended March 31, 2024 and 2023, no shares of common stock were issued under the Mustang ATM.

Equity Incentive Plan

The Company has in effect the 2016 Incentive Plan (the “Incentive Plan”). The Incentive Plan was adopted in 2016 by the Company’s stockholders and the compensation committee of the Company’s board of directors and is authorized to grant stock-based awards to directors, officers, employees and consultants. The plan initially authorized grants to issue up to 133,333 shares of authorized but unissued common stock, expires 10 years from adoption, and limits the term of each option to no more than 10 years from the date of grant. In June 2018, the Company’s stockholders approved an amendment to the Incentive Plan to increase the number of authorized shares issuable by 200,000 shares, for a total of 333,333 shares. In June 2021, the Company’s stockholders approved an amendment to the Incentive Plan to increase the number of authorized shares issuable by 200,000 shares, for a total of 533,333 shares. In June 2022, the Company’s stockholders approved an amendment to the Incentive Plan to increase the number of authorized shares issuable by 200,000 shares, for a total of 733,333 shares.

As of March 31, 2024,297,839 shares were available for future issuance under the Incentive Plan.

Stock Options

The following table summarizes stock option activities for the three months ended March 31, 2024:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​​​​Weighted Average
​ · ​ · ​ · ​ · ​ · ​ · ​ · Remaining
​ · ​ · ​ · ​ · Weighted Average · ​ · Contractual Life (in
​ · ​ · Stock Options · ​ · Exercise Price · ​ · years)
Outstanding at December 31, 202376,112​$85.953.31
Outstanding at March 31, 202476,112​$85.953.06
Options vested and exercisable at March 31, 202447,570​$85.953.06

As of March 31, 2024, the Company hadno unrecognized stock-based compensation expense related to options. The Company accounts for forfeited awards as they occur as permitted.

Restricted Stock

The following table summarizes restricted stock award activities for the three months ended March 31, 2024:

​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Weighted Average
​ · ​ · ​ · ​ · Grant Date Fair
​ · ​ · Number of Shares · ​ · Value
Nonvested at December 31, 202364,706​$11.59
Nonvested at March 31, 202464,706​$11.59

As of March 31, 2024, the Company had unrecognized stock-based compensation expense related to restricted stock of $0.3 million, which is expected to be recognized over the remaining weighted average vesting period of approximately 1.9 years.

Restricted Stock Units

Certain employees and consultants have been awarded restricted stock units with time-based vesting. The following table summarizes restricted stock units’ activities for the three months ended March 31, 2024:

​​​​​​
​ · ​ · Weighted Average
​ · ​ · ​ · ​ · Grant Date Fair
​ · ​ · Number of Units · ​ · Value
Nonvested at December 31, 202395,197​$18.78
Forfeited​(15,505)​​13.40
Vested(8,621)​22.13
Nonvested at March 31, 202471,071​$19.54

As of March 31, 2024, the Company had unrecognized stock-based compensation expense related to restricted stock units of approximately $0.3 million, which is expected to be recognized over the remaining weighted average vesting period of approximately 1.9 years.

The following table summarizes stock-based compensation expense for the three months ended March 31, 2024 and 2023 (in thousands):

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · For the three months ended March 31, · ​
​ · 2024 · 2023
General and administrative​$47​$109​
Research and development​29​126​
Total stock-based compensation expense​$76​$235​

Employee Stock Purchase Plan

Eligible employees can purchase the Company’s common stock at the end of a predetermined offering period at 85% of the lower of the fair market value at the beginning or end of the offering period. The Employee Stock Purchase Plan (“ESPP”) is compensatory and results in stock-based compensation expense. The ESPP was initially authorized in 2019 to sell up to 26,667 shares of authorized but unissued common stock. In June 2021, the Company’s stockholders approved an amendment to the ESPP to increase the number of authorized shares issuable by 40,000 shares. In addition, in June 2023, the Company’s stockholders approved an amendment to the ESPP to increase the number of authorized shares issuable thereunder by 400,000 for a total of 466,667 shares.

As of March 31, 2024,128,352 shares have been purchased and 338,315 shares are available for future sale under the Company’s ESPP.

Warrants

A summary of warrant activities for the three months ended March 31, 2024, is presented below:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​​​​Weighted Average
​ · ​ · ​ · ​ · ​ · ​ · ​ · Remaining
​ · ​ · ​ · ​ · Weighted Average · ​ · Contractual Life (in
​ · ​ · Warrants · ​ · Exercise Price · ​ · years)
Outstanding as of December 31, 20234,481,868​$1.345.34
Exercised(704,236)​——
Outstanding as of March 31, 20243,777,632​$1.595.09

Upon the cashless exercise of warrants, the Company will issue new shares of common stock. In connection with the Company’s Registered Direct Offering on October 26, 2023, the Company issued pre-funded warrants to purchase up to 1,668,236 shares of common stock, and in a concurrent private placement, the Company issued unregistered warrants to purchase up to 2,588,236 shares of common stock, which were subsequently registered in April 2024 on Form S-1 (File No. 333-275997). In connection with these offerings, H.C. Wainwright received Placement Agent Warrants to purchase up to 155,294 shares of common stock. During the three months ended March 31, 2024,704,236 of the pre-funded warrants were exercised at an exercise price of$0.001. In connection with the Public Offering the Company completed in May 2024, the 2,588,236 unregistered warrants were repriced from the original exercise price of $1.58 to $0.237. See Note 12 below.

Note 9 – Net Loss per Share

Net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period less unvested restricted stock. Since dividends are declared, paid and set aside among the holders of shares of common stock and Class A common shares pro-rata on an as-if-converted basis, the two-class method of computing net loss per share is not required. Diluted net loss per share does not reflect the effect of shares of common stock to be issued upon the exercise of warrants or outstanding Class A preferred shares, as their inclusion would be anti-dilutive. The two-class method is an earnings allocation formula that treats participating securities as having rights that would otherwise have been available to common stockholders. In addition, as our non-pre-funded warrants are participating securities, we are required to calculate diluted earnings per share under the if-converted method and utilize the most dilutive result. In periods where there is a net loss, no allocation of undistributed net loss to non-pre-funded warrants is performed as the holders of our non-pre-funded warrants are not contractually obligated to participate in our losses.

The table below summarizes potentially dilutive securities that were not considered in the computation of diluted net loss per share because they would be anti-dilutive.

​ · ​ · ​ · ​ · ​
​ · ​ · For the three months ended March 31,
​ · 2024 · 2023
Warrants(1)2,813,632​70,102
Options76,11276,112
Class A Preferred Shares250,000250,000
Unvested restricted stock awards64,70634,016
Unvested restricted stock units71,071160,391
Total3,275,521590,621

(1)Excludes 964,000 pre-funded warrants, issued in connection with the Company’s October 2023 Registered Direct Offering. The shares underlying the pre-funded warrants are included in basic net loss per share for the three months ended March 31, 2024.

Note 10 – Income Taxes

The Company incurred net operating losses and recorded a full valuation allowance against net deferred tax assets for all periods presented. Accordingly, the Company has not recorded a provision for federal or state income taxes.

The Company is subject to US federal and state income taxes. Income tax expense is the total of the current year income tax due or refundable and the change in deferred tax assets and liabilities. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance when, in the opinion of Management, it is more likely than not that some portion, or all, of the deferred tax asset will not be realized.

Note 11 – Commitments and Contingencies

Indemnification

In accordance with its Certificate of Incorporation, amended and restated bylaws and indemnification agreements, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacity. The Company has director and officer insurance to address such claims. The Company also provides indemnification of contractual counterparties in certain situations, including without limitation to clinical sites, service providers and licensors.

Leases

The Company leases office space and copiers under agreements classified as operating leases that expire on various dates through 2030. The Company’s lease liabilities result from the lease of its Mercantile Center Facility, which expires in 2030, its Plantation Street Facility, which expires in 2026, and its copiers, which expire in 2024. Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees. Certain of the Company’s leases include renewal options and escalation clauses; renewal options have not been included in the calculation of the lease liabilities and right of use assets as the Company is not reasonably certain to exercise the options. The Company does not act as a lessor or have any leases classified as financing leases. At March 31, 2024, the Company had operating lease liabilities of $2.4 million and right of use assets of $1.5 million, which were included in the Unaudited

Balance Sheet. At December 31, 2023, the Company had operating lease liabilities of $2.5 million and right of use assets of $1.6 million, which were included in the Unaudited Balance Sheet.

The following summarizes quantitative information about the Company’s operating leases:

​​​​​​​​
​For the Three Months Ended
​​​March 31,​​March 31,​
($ in thousands) · 2024 · 2023
Lease cost · ​ · ​ · ​
Operating lease cost$52$197​
Variable lease cost​​15​​224​
Total$66$421​
​​​​​​​​​
​For the Three Months Ended
​​​March 31,​​​March 31,​
($ in thousands) · 2024 · 2023
Operating cash flows from operating leases$156​$132​
Gain on lease modification​$—​​$—​
Weighted-average remaining lease term – operating leases​​4.3​​​5.7​
Weighted-average discount rate – operating leases​​9.1%​​9.1%

Maturities of our operating leases, excluding short-term leases, are as follows:

​​​​
($ in thousands) · ​ · ​
Year ended December 31, 2024​$588
Year ended December 31, 2025​​774
Year ended December 31, 2026​703
Year ended December 31, 2027​269
Year ended December 31, 2028​274
Thereafter​​303
Total​2,910
Less present value discount​​(514)
Operating lease liabilities​$2,397

Note 12 – Subsequent Events

April 2024 Reduction in Work Force

On April 10, 2024, the Company’s board of directors approved a reduction of the Company’s workforce by approximately 81% of its employee base in order to reduce costs and preserve capital due to the fundraising environment and continued uncertainty regarding the CFIUS review of the transaction with uBriGene. The workforce reduction occurred primarily in April 2024 and is expected to be substantially completed in the second quarter of 2024. As a result of these actions, the Company expects to incur personnel-related restructuring charges of approximately $0.2 million in connection with one-time employee termination cash expenditures, which are expected to be incurred in the second quarter of 2024. The Company may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the workforce reduction or retention efforts. The estimates of the costs expected to be incurred, and the timing thereof, are subject to various assumptions and actual costs may differ. The Company and its board of directors continue to evaluate all strategic and other alternatives related to the business.

Public Offering

On May 2, 2024, the Company completed a best efforts public offering (the “Offering”) of its securities pursuant to which it issued and sold to an institutional investor (the “Investor”) (i)1,160,000 shares (the “Shares”) of its common stock, (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of 15,717,638 shares of common stock (the “Pre-Funded Warrant Shares”), (iii) Series A-1 warrants (the “Series A-1 Warrants”) to purchase up to an aggregate of 16,877,638 shares of common stock (the “Series A-1 Common Warrant Shares”), (iv) Series A-2 warrants (the “Series A-2 Warrants”) to purchase up to an aggregate of 16,877,638 shares of common stock (the “Series A-2 Warrant Shares”), and (v) Series A-3 warrants (the “Series A-3 Warrants,” and together with the Series A-1 Warrants and Series A-2 Warrants, the “Warrants”) to purchase up to an aggregate of 16,877,638 shares of common stock (the “Series A-3 Warrant Shares”). Each Share or Pre-Funded Warrant was sold together withone Series A-1 Warrant to purchaseone share of common stock, one Series A-2 Warrant to purchaseone share of common stock, andone Series A-3 Warrant to purchaseone share of common stock. The public offering price for each Share and accompanying Warrants was $0.237, and the public offering price for each Pre-Funded Warrant and accompanying Warrants was $0.2369. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full. Each Warrant will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the Warrants (“Warrant Stockholder Approval”). The Series A-1 Warrant will expire on thefive-year anniversary of the Warrant Stockholder Approval. The Series A-2 Warrant will expire on thetwenty four month anniversary of the Warrant Stockholder Approval. The Series A-3 Warrant will expire on thenine month anniversary of the Warrant Stockholder Approval.

The net proceeds of the Offering, after deducting the fees and expenses of the placement agent for the Offering and other offering expenses payable by the Company, but excluding the net proceeds, if any, from the exercise of the Warrants, was approximately $3.3 million. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

Warrant Amendment Agreement

In connection with the Offering described above, the Company also entered into a warrant amendment agreement (the “Warrant Amendment Agreement”) with the Investor. Under the Warrant Amendment Agreement, the Company agreed to amend certain existing warrants to purchase up to 2,588,236 shares of common stock that were previously issued in October 2023 to the Investor, with an exercise price of $1.58 per share (the “Existing Warrants”), in consideration for their purchase of the securities in the Offering, as follows: (i) lower the exercise price of the Existing Warrants to $0.237 per share, (ii) provide that the Existing Warrants, as amended, will not be exercisable until the receipt of Warrant Stockholder Approval for the exercisability of the Warrants in the Offering, and (iii) extend the original expiration date of the Existing Warrants byfive years following the receipt of such Warrant Stockholder Approval. The Warrant Amendment Agreement became effective on May 2, 2024.

Voluntary Notice to U.S. Committee on Foreign Investment in the United State (“CFIUS”)

On May 13, 2024, the Company, uBriGene and CFIUS executed a National Security Agreement (the “NSA”), pursuant to which the Company and uBriGene agreed to abandon the Transaction and all other transactions contemplated by the Asset Purchase Agreement and the agreements entered into in connection therewith. The NSA imposes certain conditions on the Company and uBriGene and its affiliates. Most significantly, the Company agreed (i) not to effect the Transaction with uBriGene or any of its affiliates; and (ii) to appoint a point of contact representative with whom CFIUS and uBriGene’s designated contact person may interact as needed. The NSA also obligates uBriGene to sell, or otherwise dispose of, the equipment assets purchased within 180 days after the execution of the NSA, with uBriGene able to eliminate some of its obligations under the NSA if it is able to sell the equipment assets purchased back to the Company within 45 days after execution of the NSA.

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