Mustang Bio Reports First Quarter 2021 Financial Results and Recent Corporate Highlights
Mustang Bio, Inc. (NASDAQ: MBIO) reported Q1 2021 financial results, highlighting significant clinical advancements. The FDA lifted a CMC hold on the MB-107 IND for infants with XSCID, enabling patient dosing soon. The company announced progress on MB-106, a CAR T cell therapy, with FDA approval to conduct a Phase 1/2 trial for B-NHL and CLL. As of March 31, 2021, cash equivalents totaled $130.4 million, up from $98.8 million at year-end 2020. Despite increased R&D and G&A expenses, the net loss was $15 million, or $0.19 per share.
- FDA lifted CMC hold on MB-107 IND, allowing patient dosing.
- FDA approved IND for MB-106, enabling Phase 1/2 trial initiation.
- Cash and equivalents increased to $130.4 million from $98.8 million.
- Net loss increased to $15 million, compared to $11.9 million in Q1 2020.
- R&D expenses rose to $11.6 million, up from $9.6 million in Q1 2020.
- General and administrative expenses increased to $3.5 million, compared to $2.0 million in Q1 2020.
WORCESTER, Mass., May 14, 2021 (GLOBE NEWSWIRE) -- 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 first quarter ended March 31, 2021.
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “In the first quarter of 2021, we successfully executed our clinical and regulatory strategies and achieved milestones that we believe will drive Mustang’s continued progress. We announced encouraging MB-107 and MB-207 clinical updates from our investigator-IND trials for X-Linked Severe Combined Immunodeficiency (“XSCID”), as well as additional consistent safety and efficacy data pertaining to our lentiviral vector gene therapies that we have seen over the more than eight years since the first patient was treated in 2012. In January, the U.S. Food and Drug Administration (“FDA”) lifted a Chemistry, Manufacturing and Controls (“CMC”) hold on the MB-107 Investigational New Drug (“IND”) application for newly diagnosed infants under the age of two and we expect to dose the first infant in the multicenter trial soon. We also plan to file an IND for our MB-207 clinical trial for patients with XSCID who have been previously treated with hematopoietic stem cell transplantation (“HSCT”) and for whom re-treatment is indicated.”
Dr. Litchman continued, “Notably, we are thrilled with the progress of our MB-106 CD20-targeted CAR T cell therapy program for relapsed or refractory CD20+ B-cell non-Hodgkin lymphomas (“B-NHL”) and chronic lymphocytic leukemia (“CLL”). Earlier this month, we announced that the FDA approved Mustang’s IND to initiate a multicenter Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 for relapsed or refractory CD20+ B-NHL and CLL. Also, we look forward to the Fred Hutchinson Cancer Research Center presentation at the European Hematology Association 2021 (“EHA2021”) Virtual Congress next month, where Dr. Mazyar Shadman will present updated interim data from their ongoing CD20-targeted CAR T clinical trial. We are very pleased to have three active Mustang-sponsored INDs, and we anticipate having four active Mustang-sponsored INDs by the end of the year.”
Financial Results:
- As of March 31, 2021, Mustang’s cash and cash equivalents and restricted cash totaled
$130.4 million , compared to$98.8 million as of December 31, 2020, an increase of$31.6 million year-to-date. - Research and development expenses including license acquisitions were
$11.6 million for the first quarter of 2021, compared to$9.6 million for the first quarter of 2020. Non-cash, stock-based expenses included in research and development were$0.7 million for the first quarter of 2021, compared to$0.4 million for the first quarter of 2020. - General and administrative expenses were
$3.5 million for the first quarter of 2021, compared to$2.0 million for the first quarter of 2020. Non-cash, stock-based expenses included in general and administrative expenses were$1.5 million for the first quarter of 2021, compared to$0.5 million for the first quarter of 2020. - Net loss attributable to common stockholders was
$15.0 million , or$0.19 per share, for the first quarter of 2021, compared to a net loss attributable to common stockholders of$11.9 million , or$0.28 per share, for the first quarter of 2020.
Recent Corporate Highlights:
- In February 2021, Mustang announced encouraging MB-107 and MB-207 clinical updates from its investigator-IND XSCID trials, as well as additional consistent safety and efficacy data. On January 28, 2021, the FDA removed a CMC hold on the MB-107 Phase 2 clinical trial IND after reviewing a comprehensive CMC package that was submitted by Mustang in late December 2020. The company expects to enroll the first patient in this pivotal multicenter trial in the second quarter of 2021 and is targeting topline data from the trial in the second half of 2022. The company also expects to file an IND in the second quarter of 2021 for its pivotal multicenter Phase 2 clinical trial of MB-207.
- In May 2021, Mustang announced that the FDA approved its IND application to initiate a multicenter Phase 1/2 clinical trial investigating the safety and efficacy of MB-106, a CD20-targeted CAR T therapy for high-risk B-NHL and CLL.
- Also in May 2021, Mustang announced that CD20-targeted CAR T therapy data were selected for presentation at the EHA2021 Virtual Congress scheduled to take place in June. Dr. Mazyar Shadman of Fred Hutch will present updated interim data from the ongoing Phase 1/2 clinical trial for B-NHL and CLL. A copy of the abstract can be viewed online through the EHA2021 website here.
About Mustang Bio
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, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
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 share and per share amounts)
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 129,371 | $ | 97,804 | ||||
| Other receivables - related party | 17 | 15 | ||||||
| Prepaid expenses and other current assets | 1,581 | 1,715 | ||||||
| Total current assets | 130,969 | 99,534 | ||||||
| Property, plant and equipment, net | 7,080 | 7,529 | ||||||
| Fixed assets - construction in process | 1,458 | 499 | ||||||
| Restricted cash | 1,000 | 1,000 | ||||||
| Other assets | 255 | 250 | ||||||
| Operating lease right-of-use asset, net | 1,060 | 1,088 | ||||||
| Total Assets | $ | 141,822 | $ | 109,900 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 5,959 | $ | 8,747 | ||||
| Payables and accrued expenses - related party | 343 | 490 | ||||||
| Operating lease liabilities - short-term | 284 | 278 | ||||||
| Total current liabilities | 6,586 | 9,515 | ||||||
| Operating lease liabilities - long-term | 1,875 | 1,950 | ||||||
| Total Liabilities | 8,461 | 11,465 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders’ Equity | ||||||||
| Preferred stock ( | — | — | ||||||
| Common Stock ( | ||||||||
| Class A common shares, 845,385 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | — | — | ||||||
| Common shares, 85,043,153 and 70,920,693 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 8 | 7 | ||||||
| Common stock issuable, 63,688 and 2,103,122 shares as of March 31, 2021 and December 31, 2020, respectively | 218 | 7,939 | ||||||
| Additional paid-in capital | 333,566 | 275,963 | ||||||
| Accumulated deficit | (200,431 | ) | (185,474 | ) | ||||
| Total Stockholders’ Equity | 133,361 | 98,435 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 141,822 | $ | 109,900 | ||||
MUSTANG BIO, INC.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
| For the three months ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 11,618 | $ | 9,314 | ||||
| Research and development – licenses acquired | — | 250 | ||||||
| General and administrative | 3,469 | 1,956 | ||||||
| Total operating expenses | 15,087 | 11,520 | ||||||
| Loss from operations | (15,087 | ) | (11,520 | ) | ||||
| Other income (expense) | ||||||||
| Interest income | 134 | 263 | ||||||
| Interest expense | (4 | ) | (600 | ) | ||||
| Total other income (expense) | 130 | (337 | ) | |||||
| Net Loss | $ | (14,957 | ) | $ | (11,857 | ) | ||
| Net loss per common share outstanding, basic and diluted | $ | (0.19 | ) | $ | (0.28 | ) | ||
| Weighted average number of common shares outstanding, basic and diluted | 80,466,049 | 41,971,316 | ||||||
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