8-K
MUSTANG BIO, INC. (MBIO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): August 10, 2020
Mustang Bio, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-38191 | 47-3828760 |
|---|---|---|
| (State or Other Jurisdiction <br><br>of Incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) |
377 Plantation Street
Worcester, Massachusetts 01605
(Address of Principal Executive Offices)
(781) 652-4500
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written<br>communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting<br>material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ¨ | Pre-commencement<br>communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ¨ | Pre-commencement<br>communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). x
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. x
| Item 2.02. | Results of Operations and Financial Condition. |
|---|
On August 10, 2020, Mustang Bio, Inc. issued a press release to provide a corporate update and to announce its financial results for the second quarter ended June 30, 2020. A copy of such press release is being furnished as Exhibit 99.1 to this report.
| Item 9.01. | Financial Statements and Exhibits. |
|---|---|
| (d) | Exhibits. |
| --- | --- |
The following exhibit is furnished herewith:
| Exhibit Number | Description |
|---|---|
| 99.1 | Press release issued by Mustang Bio, Inc., dated August 10, 2020. |
| 104 | Cover Page Interactive Data File (formatted in Inline XBRL and<br>contained in Exhibit 101) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| **** | Mustang Bio, Inc. | |
|---|---|---|
| (Registrant) | ||
| Date: August 10, 2020 | ||
| By: | /s/ Manuel Litchman, M.D. | |
| Manuel Litchman, M.D. | ||
| President and Chief Executive Officer |
Exhibit 99.1
Mustang Bio Reports Second Quarter 2020Financial Results and Recent Corporate Highlights
Worcester, MA – August 10, 2020 – Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2020.
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “Mustang made progress on multiple fronts during the second quarter of 2020. In June, we raised gross proceeds of approximately $37.2 million in an underwritten public offering of common stock. On the clinical front, we continued to advance our robust pipeline of gene and CAR T cell therapy programs. Notably, we began enrolling patients in a Phase 1/2 clinical trial of MB-102 (CD123-targeted CAR T cell therapy) under our own Investigational New Drug (“IND”) application for relapsed or refractory blastic plasmacytoid dendritic cell neoplasm, acute myeloid leukemia and high-risk myelodysplastic syndrome. We look forward to continued progress throughout the second half of this year, as we expect to initiate our pivotal MB-107 and MB-207 lentiviral gene therapy programs for newly diagnosed infants and previously transplanted patients with X-linked severe combined immunodeficiency (“XSCID”) and to disclose additional data from our MB-106 CD20-targeted CAR T cell therapy program.”
Recent Corporate Highlights:
| · | In June 2020, Mustang raised gross proceeds of approximately $37.2 million in an underwritten public<br>offering of common stock, including the exercise of the underwriter’s option. |
|---|---|
| · | In May 2020, City of Hope presented two posters pertaining to MB-104, an innovative CS1 CAR T cell<br>therapy, at the virtual 23^rd^ Annual Meeting of the American Society of Gene & Cell Therapy (“ASGCT”). |
| --- | --- |
| · | Also in May 2020, Mustang submitted an IND application to the U.S. Food and Drug Administration<br>(“FDA”) to initiate a multi-center Phase 2 clinical trial of MB-107 in newly diagnosed infants with XSCID who are under<br>the age of two. The trial is expected to enroll 10 patients who, together with 15 patients enrolled in the current multi-center<br>trial led by St. Jude Children’s Research Hospital, will be compared with 25 matched historical control patients who have<br>undergone hematopoietic stem cell transplant (“HSCT”). The primary efficacy endpoint will be event-free survival. The<br>initiation of this trial is currently on hold pending CMC clearance by the FDA, which is expected in early Q4 2020. Mustang is<br>targeting topline data from this trial in the second half of 2022. |
| --- | --- |
| · | Mustang expects to file an IND in the fourth quarter of 2020 for a registrational multi-center<br>Phase 2 clinical trial of its lentiviral gene therapy in previously transplanted XSCID patients. This product will be designated<br>MB-207. Mustang anticipates enrolling 20 patients and comparing them to matched historical control patients who have undergone<br>a second HSCT. The company is targeting topline data from this trial in the second half of 2022. |
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| · | In the ongoing Phase 1 trial of MB-105, a PSCA-directed CAR T administered systemically to patients<br>with PSCA-positive castration resistant prostate cancer, at City of Hope, the first<br>patient to receive the therapy following a standard CAR T conditioning regimen experienced a significant reduction in his prostate-specific<br>antigen (“PSA”) at day 28. This PSA response was associated with radiographic improvement of the patient’s metastatic<br>disease. |
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| · | In April 2020, Mustang announced that the European Medicines Agency (“EMA”) granted Advanced Therapy Medicinal<br>Product (“ATMP”) classification to MB-107 for the treatment of XSCID. |
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Financial Results:
| · | As of June 30, 2020, the company’s cash, cash equivalents and restricted cash totaled $86.4<br>million, compared to $56.8 million as of March 31, 2020, and $62.4 million as of December 31, 2019. |
|---|---|
| · | Research and development expenses were $9.8 million for the second quarter of 2020. This compares<br>to $6.8 million for the second quarter of 2019. Non-cash, stock-based compensation expenses included in research and development<br>were $0.4 million for the second quarter of 2020, compared to $0.3 million for the second quarter of 2019. |
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| · | Research and development expenses from license acquisitions totaled $1.3 million for the second<br>quarter of 2020, compared to $0.2 million for the second quarter of 2019. |
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| · | General and administrative expenses were $3.0 million for the second quarter of 2020. This compares<br>to $3.2 million for the second quarter of 2019. Non-cash, stock-based compensation expenses included in general and administrative<br>expenses were $1.5 million for the second quarter of 2020, compared to $1.6 million for the second quarter of 2019. |
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| · | Net loss attributable to common stockholders was $14.6 million, or $0.32 per share, for the second<br>quarter of 2020, compared to a net loss attributable to common stockholders of $10.4 million, or $0.29 per share, for the second<br>quarter of 2019. |
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About MustangBio
Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR T therapies across multiple cancers, as well as a lentiviral gene therapy for XSCID. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). Mustang was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.mustangbio.com.
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Company Contacts:
Jaclyn Jaffe and William Begien
Mustang Bio, Inc.
(781) 652-4500
ir@mustangbio.com
Investor Relations Contact:
Daniel Ferry
LifeSci Advisors, LLC
(617) 430-7576
daniel@lifesciadvisors.com
Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com
MUSTANG BIO, INC.
Condensed Balance Sheets
($ in thousands, except for share andper share amounts)
| December 31, | |||||
|---|---|---|---|---|---|
| 2019 | |||||
| ASSETS | |||||
| Current Assets: | |||||
| Cash and cash equivalents | 85,361 | $ | 61,413 | ||
| Other receivables - related party | 25 | 19 | |||
| Prepaid expenses and other current assets | 886 | 1,631 | |||
| Total current assets | 86,272 | 63,063 | |||
| Property, plant and equipment, net | 7,675 | 6,779 | |||
| Fixed assets - construction in process | 493 | 1,157 | |||
| Restricted cash | 1,000 | 1,000 | |||
| Other assets | 250 | 250 | |||
| Operating lease right-of-use asset, net | 1,140 | 1,196 | |||
| Total Assets | 96,830 | $ | 73,445 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current Liabilities: | |||||
| Short-term notes payable | 5,000 | $ | 1,250 | ||
| Accounts payable and accrued expenses | 8,996 | 5,668 | |||
| Payables and accrued expenses - related party | 491 | 596 | |||
| Operating lease liabilities - short-term | 265 | 257 | |||
| Total current liabilities | 14,752 | 7,771 | |||
| Notes payable | 8,959 | 12,179 | |||
| Operating lease liabilities - long-term | 2,090 | 1,843 | |||
| Total Liabilities | 25,801 | 21,793 | |||
| Commitments and Contingencies | |||||
| 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, 2020 and December 31, 2019 respectively | — | — | |||
| Common Stock (0.0001 par value), 85,000,000 shares authorized | |||||
| Class A common shares, 845,385 shares issued and outstanding as of June 30, 2020 and December 31, 2019 respectively | — | — | |||
| Common shares, 54,826,243 and 39,403,519 shares issued and outstanding as of June 30, 2020 and December 31, 2019 respectively | 5 | 4 | |||
| Common stock issuable, 0 and 1,206,667 shares as of June 30, 2020 and December 31, 2019 respectively | — | 4,923 | |||
| Additional paid-in capital | 222,938 | 172,184 | |||
| Accumulated deficit | (151,914 | ) | (125,459 | ) | |
| Total Stockholders’ Equity | 71,029 | 51,652 | |||
| Total Liabilities and Stockholders’ Equity | 96,830 | $ | 73,445 |
All values are in US Dollars.
MUSTANG BIO, INC.
Condensed Statements of Operations
($ in thousands, except for share andper share amounts)
(Unaudited)
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 9,830 | $ | 6,823 | $ | 19,144 | $ | 13,783 | ||||
| Research and development – licenses acquired | 1,300 | 200 | 1,550 | 650 | ||||||||
| General and administrative | 2,991 | 3,189 | 4,947 | 5,533 | ||||||||
| Total operating expenses | 14,121 | 10,212 | 25,641 | 19,966 | ||||||||
| Loss from operations | (14,121 | ) | (10,212 | ) | (25,641 | ) | (19,966 | ) | ||||
| Other income (expense) | ||||||||||||
| Interest income | 142 | 387 | 405 | 539 | ||||||||
| Interest expense | (619 | ) | (574 | ) | (1,219 | ) | (585 | ) | ||||
| Total other income (expense) | (477 | ) | (187 | ) | (814 | ) | (46 | ) | ||||
| Net Loss | $ | (14,598 | ) | $ | (10,399 | ) | $ | (26,455 | ) | $ | (20,012 | ) |
| Net loss per common share outstanding, basic and diluted | $ | (0.32 | ) | $ | (0.29 | ) | $ | (0.61 | ) | $ | (0.62 | ) |
| Weighted average number of common shares outstanding, basic and diluted | 45,023,030 | 36,306,710 | 43,497,173 | 32,149,352 |