−Removed: for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
−Removed: common stock has been quoted on the NASDAQ Global Market since August 22, 2017, under the symbol “MBIO.”
−Removed: this there was no public market for our common stock.
−Removed: Authorized for Issuance Under Equity Compensation Plans
−Removed: November 30, 2017, we filed a registration statement on Form S-8 under the Securities Act registering the common stock issued,
−Removed: issuable or reserved for issuance under our 2016 Plan.
−Removed: That registration statement became effective immediately upon filing, and
−Removed: shares covered by the registration statement are eligible for sale in the public markets, subject to grant of the underlying awards,
−Removed: vesting provisions and Rule 144 limitations applicable to our affiliates.
−Removed: of December 31, 2019, there were approximately 123 holders of record of our common stock and one holder of record for our
−Removed: Class A common stock.
−Removed: The actual number of stockholders of our common shares is greater than this number of record holders and
−Removed: includes stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees.
−Removed: number of holders of record also does not include stockholders whose shares may be held in trust by other entities.
−Removed: have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our
−Removed: common stock in the foreseeable future.
−Removed: We intend to retain all available funds and any future earnings to fund the development
−Removed: and expansion of our business.
−Removed: Any future determination to pay dividends will be at the discretion of our board of directors and
−Removed: will depend upon a number of factors, including our results of operations, financial condition, future prospects, contractual
−Removed: restrictions, restrictions imposed by applicable law and other factors our board of directors deems relevant.
−Removed: Sales of Unregistered Securities
−Removed: Financial Data
−Removed: Management’s
−Removed: Discussion and Analysis of the Results of Operations
−Removed: in the following discussion and throughout this report that are not historical in nature are “forward-looking statements.”
−Removed: You can identify forward-looking statements by the use of words such as “expect,”
−Removed: “anticipate,”
−Removed: “estimate,”
−Removed: “may,”
−Removed: “will,”
−Removed: “should,”
−Removed: “intend,”
−Removed: “believe,”
−Removed: and similar expressions.
−Removed: Although we believe the expectations reflected in these forward-looking statements are reasonable, such statements are inherently
−Removed: subject to risk and we can give no assurances that our expectations will prove to be correct.
−Removed: Actual results could differ from
−Removed: those described in this report because of numerous factors, many of which are beyond our control.
−Removed: These factors include, without
−Removed: limitation, those described under Item 1A “Risk Factors.”
−Removed: We undertake no obligation to update these forward-looking
−Removed: statements to reflect events or circumstances after the date of this report or to reflect actual outcomes.
−Removed: Please see “Forward-Looking
−Removed: Statements”
−Removed: at the beginning of this Form 10-K.
−Removed: following discussion of our financial condition and results of operations should be read in conjunction with our financial statements
−Removed: and the related notes thereto and other financial information appearing elsewhere in this Form 10-K.
−Removed: We undertake no obligation
−Removed: to update any forward-looking statements in the discussion of our financial condition and results of operations to reflect events
−Removed: or circumstances after the date of this report or to reflect actual outcomes.
−Removed: (“Mustang,”
−Removed: “We,”
−Removed: “Us”
−Removed: or the “Company”) is a clinical-stage biopharmaceutical
−Removed: company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic
−Removed: cancers, solid tumors and rare genetic diseases.
−Removed: We aim to acquire rights to these technologies by licensing or otherwise acquiring
−Removed: an ownership interest in the technologies, funding their research and development and eventually either out-licensing or bringing
−Removed: the technologies to market.
−Removed: Our pipeline is currently focused in three core areas:
−Removed: therapy programs for rare genetic disorders, CAR T therapies for hematologic malignancies and CAR T therapies for solid tumors.
−Removed: For each therapy we have partnered with world class research institutions.
−Removed: For our gene therapy programs we have partnered with
−Removed: Jude in the development of a first-in-class ex vivo lentiviral treatment of XSCID, and for our CAR T therapies we have
−Removed: partnered with the COH, Fred Hutch and Nationwide.
−Removed: partnership with St.
−Removed: Jude, our gene therapy program (MB-107) is being conducted under
−Removed: an exclusive license to develop a potentially curative treatment for XSCID, a rare genetic
−Removed: immune system condition in which affected patients do not live beyond infancy without
−Removed: This first-in-class ex vivo lentiviral gene therapy is currently in
−Removed: two Phase 1/2 clinical trials:
−Removed: a multicenter trial in newly diagnosed infants sponsored
−Removed: Jude and a single-center trial in previously transplanted patients sponsored by
−Removed: the National Institutes of Health (“NIH”).
−Removed: We plan to file separate Investigational
−Removed: New Drug Applications in 2020 in order to conduct a pivotal non-randomized phase 2 registration
−Removed: trial in each of the two patient populations.
−Removed: pipeline of CAR T therapies is being developed under exclusive licenses from several world class research institutions.
−Removed: is to license these technologies, support preclinical and clinical research activities by our partners and transfer the underlying
−Removed: technology to our cell processing facility located in Worcester, Massachusetts, to conduct our own clinical trials.
−Removed: We are developing CAR T therapies for hematologic malignancies
−Removed: in partnership with COH targeting CD123 (MB-102) and CS1 (MB-104) and with Fred Hutch targeting CD20 (MB-106).
−Removed: Phase 1 clinical
−Removed: trials sponsored by COH for MB-102 and MB-104 and by Fred Hutch for MB-106 are underway.
−Removed: In the third quarter of 2019 the FDA approved
−Removed: our IND application to initiate a multicenter Phase 1/2 clinical trial of MB-102, and our clinical trial is expected to begin
−Removed: enrollment in the first half of 2020 for the treatment of patients with acute myeloid leukemia, blastic plasmacytoid dendritic
−Removed: cell neoplasm, and high-risk myelodysplastic syndrome.
−Removed: We expect to file an IND for MB-104 in the second half of 2020 and
−Removed: to initiate our own Phase 1 clinical trial shortly thereafter for the treatment of patients with multiple myeloma.
−Removed: to file an IND and initiate our own clinical trial for MB-106 for the treatment of patients with non-Hodgkin lymphoma and chronic
−Removed: lymphocytic leukemia.
−Removed: We are also developing CAR
−Removed: T therapies for solid tumors in partnership with COH targeting IL13R a 2
−Removed: (MB-101), HER2 (MB-103) and PSCA (MB-105).
−Removed: In addition, we have partnered with Nationwide for the C134 oncolytic virus (MB-108)
−Removed: in order to enhance the activity of MB-101 for the treatment of patients with GBM.
−Removed: Phase 1 clinical trials sponsored by COH for
−Removed: MB-101, MB-103 and MB-105 are underway.
−Removed: A Phase 1 clinical trial sponsored by UAB for MB-108 began during the third quarter of
−Removed: 2019 and, in the second half of 2020, we plan to file an IND for the combination of MB-101 and MB-108 for the treatment of patients
−Removed: We also plan to file INDs and initiate our own clinical trials for MB-103 for the treatment of patients with metastatic
−Removed: breast cancer to brain and for MB-105 for the treatment of patients with prostate and pancreatic cancer .
−Removed: (IL13Rα2 CAR T for Glioblastoma)
−Removed: October 2019, Mustang announced that COH received $4.1 million in grant awards for a clinical trial of MB-101 (IL13Rα2-targeted
−Removed: CAR T) in combination with nivolumab (commercial name:
−Removed: Opdivo®) and ipilimumab (commercial name:
−Removed: Yervoy®) in patients
−Removed: with recurrent malignant glioma.
−Removed: The trial, which is now enrolling patients, is the first human study to combine IL13Rα2-targeted
−Removed: CAR T cell therapy with checkpoint inhibitors, as well as the first to locally deliver CAR T cells with systemic nivolumab combination
−Removed: Additional information on the trial can be found on www.CinicalTrials.gov using identifier NCT04003649.
−Removed: (PSCA CAR T for Prostate & Pancreatic Cancers)
−Removed: In September 2019, we announced that COH had opened and initiated
−Removed: patient treatments in a Phase 1 clinical trial of MB-105, a PSCA CAR T technology for the treatment of prostate cancer.
−Removed: information on the Phase 1 trial can be found on www.CinicalTrials.gov using identifier NCT03873805.
−Removed: (CD123 CAR T for AML)
−Removed: On August 5, 2019, we announced that the FDA had approved our
−Removed: IND application to initiate a multi-center Phase 1/2 clinical trial of MB-102 (CD123 CAR T) in acute myeloid leukemia (“AML”),
−Removed: blastic plasmacytoid dendritic cell neoplasm (“BPDCN”) and high-risk myelodysplastic syndrome (“hrMDS”).
−Removed: We will begin enrollment on our MB-102 clinical trial in the first half of 2020 and process patient cells in our manufacturing
−Removed: facility, which opened in June 2018.
−Removed: Additional information on the trial can be found on www.CinicalTrials.gov using identifier
−Removed: In July 2019,
−Removed: we announced that the FDA had granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of AML.
−Removed: The FDA also previously
−Removed: granted Orphan Drug Designation to MB-102 for the treatment of BPDCN.
−Removed: The FDA grants Orphan Drug Designation to drugs and biologics
−Removed: that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer
−Removed: than 200,000 people in the U.S.
−Removed: Orphan Drug Designation provides certain incentives, such as tax credits toward the cost of clinical
−Removed: trials and prescription drug user fee waivers.
−Removed: If a product holding Orphan Drug Designation receives the first FDA approval for
−Removed: the disease in which it has such designation, the product is entitled to seven years of market exclusivity, which is independent
−Removed: from intellectual property protection.
−Removed: (HER2 CAR T for GBM & Metastatic Breast Cancer to Brain)
−Removed: In August 2019,
−Removed: we announced that the California Institute for Regenerative Medicine had awarded a $9.3 million grant to Dr.
−Removed: Saul Priceman at
−Removed: COH to conduct a Phase 1 clinical trial evaluating the safety and effectiveness of intraventricular delivery of HER2-directed
−Removed: CAR T cells to the brains of patients with HER2-positive breast cancer with brain metastases.
−Removed: City of Hope exclusively licensed
−Removed: MB-103 to us in 2017.
−Removed: Additional information on the Phase 1 trial can be found on www.CinicalTrials.gov using identifier
−Removed: (CD20-targeted CAR T cell therapy)
−Removed: In February 2020, we announced that the first subject treated
−Removed: with the optimized MB-106 (CD20-targeted, autologous CAR T cell therapy) manufacturing process, developed in collaboration between
−Removed: Mustang and Fred Hutch, has achieved a complete response (CR) at the lowest starting dose in an ongoing Phase 1/2 clinical trial.
−Removed: The Phase 1/2, open-label, dose-escalation trial is evaluating the maximum tolerated dose of MB-106.
−Removed: Secondary endpoints include
−Removed: safety and toxicity, preliminary antitumor activity as measured by overall response rate and complete remission rate, progression-free
−Removed: survival, and overall survival.
−Removed: Fred Hutch intends to enroll approximately 30 subjects on the trial, which is being led by principal
−Removed: investigator Mazyar Shadman, M.D., M.P.H., Assistant Member of Fred Hutch’s Clinical Research Division.
−Removed: Additional information
−Removed: on the Phase 1/2 trial can be found on www.CinicalTrials.gov using identifier NCT03277729.
−Removed: (Ex vivo Lentiviral Therapy for X-linked Severe Combined Immunodeficiency (XSCID))
−Removed: In April 2019, the New England Journal
−Removed: of Medicine published data from St.
−Removed: The data is from a Phase 1/2 clinical trial of a lentiviral gene therapy for the
−Removed: treatment of newly diagnosed infants under two years old with XSCID, also known as bubble boy disease.
−Removed: The data demonstrates that
−Removed: the lentiviral gene therapy achieved normalization of T-cell numbers in all eight newly diagnosed infants with XSCID to date, and
−Removed: disseminated infections resolved completely in all affected infants.
−Removed: Seven of the eight infants treated have developed normal IgM
−Removed: levels to date.
−Removed: Four of those seven infants have discontinued monthly infusions of intravenous immunoglobulin (“IVIG”)
−Removed: therapy to date.
−Removed: Three of those four infants who discontinued monthly IVIG infusions have responded to vaccines to date.
−Removed: In August 2019, the Company, together with St.
−Removed: Jude, announced
−Removed: that MB-107 was granted the Regenerative Medicine Advanced Therapy (“RMAT”) designation by the FDA.
−Removed: Under the RMAT
−Removed: designation, the FDA will help facilitate the program’s expedited development and review and provide guidance on generating
−Removed: the evidence needed to support the approval of MB-107 for XSCID.
−Removed: in August 2019, we entered into a license agreement with CSL Behring (Calimmune) for the Cytegrity TM stable producer
−Removed: cell line developed and used by St.
−Removed: The Cytegrity™
−Removed: stable producer cell line will be used to produce the viral vector
−Removed: Updated Phase 1/2 clinical data for MB-107 were selected for
−Removed: oral and poster presentations at the 61st American Society of Hematology (“ASH”) Annual Meeting, which was held in
−Removed: December 2019.
−Removed: Data demonstrated that MB-107 preceded by low-dose busulfan conditioning continued to be well tolerated and resulted
−Removed: in the development of a functional immune system in newly diagnosed infants with XSCID, as well as in previously transplanted patients
−Removed: with XSCID who had experienced declining T cell function and recurrent infections.
−Removed: In this latter population, the enhanced transduction
−Removed: procedure demonstrated faster time to NK cell recovery and faster recovery from chronic norovirus infection.
−Removed: (C134 Oncolytic Virus for GBM)
−Removed: In February 2019, we partnered and entered into an exclusive
−Removed: worldwide license agreement with Nationwide Children’s Hospital to develop an oncolytic virus (C134), an attenuated herpes
−Removed: simplex virus type 1, for the treatment of GBM.
−Removed: We intend to combine MB-108 with MB-101 (IL13Rα2 CAR T) to potentially enhance
−Removed: efficacy in treating GBM.
−Removed: May 2019, the FDA granted Orphan Drug Designation to MB-108 for the treatment of malignant glioma, a type of brain cancer with
−Removed: a median survival of less than 18 months.
−Removed: October 2019, we announced that the first participant was dosed in a Phase 1 clinical trial to determine the safety and efficacy
−Removed: of MB-108 in recurrent GBM.
−Removed: Additional information on the Phase 1 trial can be found on www.CinicalTrials.gov using identifier
−Removed: August 2019, we filed a shelf registration statement No.
−Removed: 333-233350 on Form S-3 (the “2019 Mustang S-3”), which was
−Removed: declared effective on September 30, 2019.
−Removed: Under the 2019 Mustang S-3, we may sell up to a total of $75.0 million of our securities.
−Removed: As of December 31, 2019, no sales were made under the 2019 Mustang S-3.
−Removed: March 29, 2019 (the “Closing Date”), the Company entered into a $20.0 million Loan Agreement with Horizon, the
−Removed: proceeds of which will provide the Company with additional working capital to continue development of its gene and cell therapies.
−Removed: In accordance with the Loan Agreement, $15.0 million of the $20.0 million loan was funded on the Closing Date, with the remaining
−Removed: $5.0 million fundable upon the Company achieving certain predetermined milestones.
−Removed: At-the-Market
−Removed: July 13, 2018, the Company filed a shelf registration statement No.
−Removed: 333-226175 on Form S-3, as amended on July 20, 2018 (the “2018
−Removed: Mustang S-3”), which was declared effective in August 2018.
−Removed: Under the 2018 Mustang S-3, the Company may sell up to a total
−Removed: of $75.0 million of its securities.
−Removed: In connection with the 2018 Mustang S-3, the Company entered into an At-the-Market Issuance
−Removed: Sales Agreement (the “Mustang ATM”) with B.
−Removed: Riley FBR, Inc., Cantor Fitzgerald & Co., National Securities Corporation,
−Removed: and Oppenheimer & Co.
−Removed: (each an "Agent"
−Removed: and collectively, the “Agents”), relating to the sale of
−Removed: shares of common stock.
−Removed: Under the Mustang ATM, the Company pays the Agents a commission rate of up to 3.0% of the gross proceeds
−Removed: from the sale of any shares of common stock.
−Removed: the year ended December 31, 2019, the Company issued approximately 3.5 million shares of common stock at an average price of $6.42
−Removed: per share for gross proceeds of $22.5 million under the Mustang ATM.
−Removed: In connection with these sales, we paid aggregate fees of
−Removed: approximately $0.5 million for net proceeds of approximately $22.0 million.
−Removed: No sales were made under the 2018 Mustang ATM in 2018.
−Removed: Offering of Common Stock
−Removed: April 30, 2019, we announced the pricing of an underwritten public offering, whereby we sold 6,875,000 shares of common stock,
−Removed: (plus a 30-day option to purchase up to an additional 1,031,250 shares of common stock, which was fully exercised) at a price
−Removed: of $4.00 per share for gross proceeds of approximately $31.6 million, before deducting underwriting discounts and commissions
−Removed: and offering expenses.
−Removed: In connection with the public offering, the Company paid aggregate fees of approximately $2.1 million for
−Removed: net proceeds of approximately $29.5 million.
−Removed: The shares were sold under the 2018 Mustang S-3, filed with the Securities and Exchange
−Removed: The offering closed on May 2, 2019, and the over-allotment closing was on May 8, 2019.
−Removed: August 16, 2019, the Company’s Board adopted resolutions of the Board to ratify, approve and recommend stockholder approval
−Removed: of an amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended, to revise Article IV, Authorized
−Removed: Stock thereof in order to effect an increase in the authorized number of shares of the Company’s common stock, par value
−Removed: $0.0001, from 50.0 million to 85.0 million (the “Amendment”).
−Removed: On August 16, 2019, the Company received approval of
−Removed: the Amendment by written consent in lieu of a meeting from the holders of a majority of issued and outstanding shares of the Company’s
−Removed: common and preferred stock.
−Removed: The increase in authorized shares to 85.0 million became effective on September 30, 2019.
−Removed: date, we have not received approval for the sale of our product candidates in any market and, therefore, have not generated any
−Removed: product sales from our product candidates.
−Removed: In addition, we have incurred substantial operating losses since our inception, and
−Removed: expect to continue to incur significant operating losses for the foreseeable future and may never become profitable.
−Removed: As of December
−Removed: 31, 2019, we have an accumulated deficit of $125.5 million.
−Removed: are a majority-controlled subsidiary of Fortress Biotech, Inc.
−Removed: (“Fortress”).
−Removed: As a “Controlled Company”
−Removed: we rely on the exemption provided by Nasdaq Listing Rule 5615(c)(2), which permits us to maintain less than a majority of independent
−Removed: directors on our board.
−Removed: Accounting Policies and Use of Estimates
−Removed: Note 2 to our Financial Statements.
−Removed: of Operations
−Removed: of the Years Ended December 31, 2019 and 2018
−Removed: the year ended December 31,
−Removed: in thousands)
−Removed: Operating expenses:
−Removed: and development
−Removed: and development –
−Removed: licenses acquired
−Removed: and administrative
−Removed: operating expenses
−Removed: from operations
−Removed: Other income (expense)
−Removed: other income (expense)
−Removed: and Development Expenses
−Removed: and development expenses primarily consist of personnel related expenses, including salaries, benefits, travel, and other related
−Removed: expenses, stock-based compensation, payments made to third parties for license, sponsored research and milestone costs related
−Removed: to in-licensed products and technology, payments made to third party contract research organizations for preclinical and clinical
−Removed: studies, investigative sites for clinical trials, consultants, the cost of acquiring and manufacturing clinical trial materials,
−Removed: costs associated with regulatory filings, laboratory costs and other supplies.
−Removed: For the year ended December 31, 2019,
−Removed: research and development expenses were approximately $30.0 million, compared to approximately $21.1 million, an increase of $8.9
−Removed: For the year ended December 31, 2019, research and development expenses primarily consisted of $6.1 million for Sponsored
−Removed: Research and Clinical Trial Agreements with our academic partners, $7.8 million for personnel compensation and benefits, $0.9
−Removed: million for stock compensation expense, $4.4 million for laboratory supplies, $3.2 million related to consulting and outside services,
−Removed: $3.6 million for clinical trial costs, $0.9 million related to facility costs, and $1.3 million depreciation expense.
−Removed: year ended December 31, 2018, research and development expenses primarily consisted of $5.7 million for Sponsored Research and
−Removed: Clinical Trial Agreements with our academic partners, $4.3 million for personnel compensation and benefits, $3.4 million for stock
−Removed: compensation expense, $2.3 million for laboratory supplies, $1.1 million related to consulting and outside services, $0.5 million
−Removed: related to facility costs, and $0.6 million depreciation expense.
−Removed: the year ended December 31, 2019, research and development expenses - licenses acquired were approximately $6.3 million, compared
−Removed: to approximately $3.4 million, an increase of $2.9 million.
−Removed: For the year ended December 31, 2019, research and development expenses
−Removed: - licenses acquired consisted of $4.9 million for the annual stock dividend to Fortress, $0.2 million for an upfront fee for our
−Removed: license with Nationwide Children’s Hospital, $0.2 million for our license with CSL Behring (Calimmune), $0.3 million for
−Removed: a development milestone paid to UCLA in connection with MB-105 and $0.7 million in connection with our licenses with COH.
−Removed: the year ended December 31, 2018, research and development expenses - licenses acquired consisted of $2.1 million for the annual
−Removed: stock dividend to Fortress, $1.0 million for an upfront fee for our license with St.
−Removed: Jude for the treatment of XSCID and $0.3
−Removed: million in connection with our licenses with COH.
−Removed: expect our research and development activities to increase as we develop our existing product candidates and potentially acquire
−Removed: new product candidates, reflecting increasing costs associated with the following:
−Removed: employee-related expenses, which include salaries and benefits;
−Removed: fees and milestone payments related to in-licensed products and technology;
−Removed: incurred under agreements with contract research organizations, investigative sites and consultants that conduct our clinical
−Removed: trials and our preclinical activities;
−Removed: facility expenses, which include rent,
−Removed: utilities and maintenance costs;
−Removed: cost of acquiring and manufacturing clinical trial materials;
−Removed: associated with non-clinical activities, and regulatory approvals.
−Removed: and Administrative Expenses
−Removed: and administrative expenses consist primarily of salaries and related expenses, including stock-based compensation, for executives
−Removed: and other administrative personnel, recruitment expenses, professional fees and other corporate expenses, including investor relations,
−Removed: legal activities including patent fees, and facilities-related expenses.
−Removed: For the year ended December 31, 2019, general
−Removed: and administrative expenses were approximately $9.6 million, compared to approximately $6.8 million, an increase of $2.8 million.
−Removed: For the year ended December 31, 2019, general and administrative expenses primarily consisted of $1.7 million for legal and professional
−Removed: fees, $1.7 million for personnel compensation and benefits, $1.8 million for stock compensation expense, $1.7 million for the equity
−Removed: fee on issuance of common shares to Fortress Biotech, $1.1 million related to consulting fees and $0.5 million for insurance and
−Removed: For the year ended December 31, 2018, general and administrative expenses consisted primarily of $1.3 million for legal
−Removed: and professional fees, $1.5 million for personnel compensation and benefits, $1.5 million for stock compensation expense and $0.6
−Removed: million for insurance and taxes.
−Removed: anticipate general and administrative expenses will increase in future periods, reflecting continued and increasing costs associated
−Removed: of our expanded research and development activities, including additional product candidates entering the clinic;
−Removed: compensation granted to key employees and non-employees;
−Removed: of business development activities;
−Removed: professional fees and other costs associated with the regulatory requirements and increased compliance associated with being
−Removed: a publicly traded company.
−Removed: Income (Expense)
−Removed: Other income (expense) consists primarily
−Removed: of interest income earned on cash balances and short-term investments and interest expense on the Company’s notes payable.
−Removed: For the year ended December 31, 2019 and 2018, total other income (expense) were approximately $0.5 million expense and $0.6 million
−Removed: income, respectively.
−Removed: and Capital Resources
−Removed: Company has incurred substantial operating losses and expects to continue to incur significant operating losses for the foreseeable
−Removed: future and may never become profitable.
−Removed: As of December 31, 2019, the Company had an accumulated deficit of $125.5 million.
−Removed: The Company has funded its operations to date primarily through
−Removed: the sale of equity.
−Removed: The Company expects to continue to use the proceeds from previous financing transactions primarily for general
−Removed: corporate purposes, including financing the Company’s growth, developing new or existing product candidates, and funding
−Removed: capital expenditures, acquisitions and investments.
−Removed: The Company currently anticipates that its cash and cash equivalents balances
−Removed: as of December 31, 2019, are sufficient to fund its anticipated operating cash requirements for at least one year from the date
−Removed: of this Form 10-K.
−Removed: Company will be required to expend significant funds in order to advance the development of its product candidates.
−Removed: The Company’s
−Removed: estimates as to how long it expects its existing cash to be able to continue to fund its operations is based on assumptions that
−Removed: may prove to be inaccurate, and it could use its available capital resources sooner than it currently expects, as a result of
−Removed: unforeseen events.
−Removed: Such changes in circumstances may require that the Company alter development plans of certain of its product
−Removed: Accordingly, the Company will require additional financings through equity and debt offerings, collaborations and
−Removed: licensing arrangements or other sources to fully develop, prepare regulatory filings, obtain regulatory approvals and commercialize
−Removed: its existing and any new product candidates.
−Removed: If the Company is unable to arrange for such financings, or unable to arrange for
−Removed: them on terms acceptable to the Company, the Company’s current development plans and plans for expansion of its facility
−Removed: and general and administrative infrastructure will be curtailed.
−Removed: Flows for the Years Ended December 31, 2019 and 2018
−Removed: the year ended December 31,
−Removed: in thousands)
−Removed: of cash flows data:
−Removed: Total cash (used in)
−Removed: change in cash, cash equivalents and restricted cash
−Removed: cash used in operating activities was $33.6 million for the year ended December 31, 2019, compared to $19.2 million for the year
−Removed: ended December 31, 2018.
−Removed: Net cash used in operating activities for the year ended December 31, 2019, was primarily due to approximately
−Removed: $46.4 million in net loss, partially offset by $4.9 million of common shares issuable for Founders shares, $2.7 million of non-cash
−Removed: stock compensation expenses, $1.7 million of equity fee on issuance of common shares to Fortress Biotech, $1.4 million of research
−Removed: and development-licenses acquired, $1.3 million of depreciation expense and $0.7 million of accretion of debt discount.
−Removed: cash used in operating activities during the year ended December 31, 2018, was primarily due to approximately $30.7 million in
−Removed: net loss, partially offset by $5.0 million of non-cash stock compensation expenses, $1.3 million of research and development-licenses
−Removed: acquired, $2.1 million of common shares issuable for Founders shares, $2.5 million in change in operating assets and liabilities,
−Removed: and $0.6 million of depreciation expense.
−Removed: cash provided by investing activities was $13.9 million for the year ended December 31, 2019, representing our $17.6 million in
−Removed: maturities of certificates of deposits, offset by $1.4 million in purchases of research and development licenses and $2.3 million
−Removed: in purchases of fixed assets.
−Removed: cash provided by investing activities was $0.6 million for the year ended December 31, 2018, representing our purchase of $52.5
−Removed: million investment in certificates of deposits held to maturity, $6.9 million in purchases of fixed assets and construction in
−Removed: process, and $1.1 million in acquisition costs of acquired licenses, offset by $61.0 million in maturities of certificates of
−Removed: cash provided by financing activities was $65.1 million during the year ended December 31, 2019, due to net proceeds of $13.6
−Removed: million from the Horizon Notes;
−Removed: gross proceeds of $22.5 million, net of offering costs of $0.5 million, from the Mustang ATM;
−Removed: and gross proceeds of $31.6 million, net of offering costs of $2.1 million, from our May 2019 underwritten public offering.
−Removed: cash provided by financing activities was $0.2 million during the year ended December 31, 2018, due to net proceeds from the exercise
−Removed: and Qualitative Disclosures About Market Risks
−Removed: Statements and Supplementary Data.
−Removed: information required by this Item is set forth in the financial statements and notes thereto beginning at page F-1 of this Annual
−Removed: Report on Form 10-K.
−Removed: in and Disagreements with Accountants on Accounting and Financial Disclosure.
+Added: Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
+Added: Market information
+Added: Our common stock has been quoted on the NASDAQ Global Market since August 22, 2017, under the symbol “MBIO.” Prior to this there was no public market for our common stock.
+Added: Securities Authorized for Issuance Under Equity Compensation Plans
+Added: On November 30, 2017, we filed a registration statement on Form S-8 under the Securities Act registering the common stock issued, issuable or reserved for issuance under our 2016 Plan.
+Added: That registration statement became effective immediately upon filing, and shares covered by the registration statement are eligible for sale in the public markets, subject to grant of the underlying awards, vesting provisions and Rule 144 limitations applicable to our affiliates.
+Added: Holders of Record
+Added: As of December 31, 2020, there were approximately 113 holders of record of our common stock and one holder of record for our Class A common stock.
+Added: The actual number of stockholders of our common shares is greater than this number of record holders and includes
+Added: stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees.
+Added: This number of holders of record also does not include stockholders whose shares may be held in trust by other entities.
+Added: We have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
+Added: We intend to retain all available funds and any future earnings to fund the development and expansion of our business.
+Added: Any future determination to pay dividends will be at the discretion of our board of directors and will depend upon a number of factors, including our results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors our board of directors deems relevant.
+Added: Recent Sales of Unregistered Securities
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.