Corporate Presentation
October 2023
Cautionary Statement
This presentation contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For such forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, any statements relating to our growth strategy, products and product development programs , including the timing of and our ability to make regulatory filings such as INDs and other applications and to obtain regulatory approvals for our product candidates, statements concerning the potential of therapies and product candidates, statements regarding the potential addressable market of our therapies and any other statements that are not descriptions of fact. 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 price. Factors that could cause actual results to differ materially from those currently anticipated include , among other things, risks related to whether the Company's third-party manufacturer is able to successfully perform its obligation to produce the Company's products under the manufacturing services agreement on a timely basis and to acceptable standards, disruption from the sale of the Company's manufacturing facility making it more difficult to maintain business and operational relationships, negative effects of the announcement of the consummation of the sale of the Company's manufacturing facility on the market price of the Company's common stock, significant transaction costs, the development stage of the Company's primary product candidates, 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 Part I, Item 1A, "Risk Factors," in our Annual Report on Form 10-K filed on March 30, 2023, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. 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 may be required by law. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this presentation should be read as applying mutatis mutandis to every other instance of such information appearing herein, as required by law.
This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other data about our industry. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such data and estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. Neither we nor our affiliates, advisors or representatives makes any representation as to the accuracy or completeness of that data or undertake to update such data after the date of this presentation.
Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained by third-party sources and the Company's own internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified and makes not representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources.
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Mustang Bio is Pioneering Innovative CAR-T Therapies for Cancer and Gene Therapies for Primary Immunodeficiencies
Milestones
Over Next 6
Months
- First data disclosed from Ph 1 multicenter Mustang-sponsoredCAR-T trial for non-Hodgkin lymphoma (NHL) & chronic lymphocytic leukemia (CLL); expect more extensive data disclosure by year end, start of first pivotal trial mid-2024
- Expect to file IND for groundbreaking combination Ph 1 trial of CAR-T + oncolytic virus in malignant brain tumors
- Expect to publish proof-of-concept data in a murine cancer model for in vivo CAR-T program
Key Programs
▪ First-in-classCD20-targetedCAR-T for non-Hodgkin lymphoma & chronic lymphocytic leukemia | ||
MB-106 | - First multicenter data provide early confirmation of Phase 1 Fred Hutch trial across multiple institutions & | |
multiple indolent histologies; expect to present entire phase 1 indolent NHL arm in 4Q 2023 | ||
- Expect to treat 1st pt in pivotal Ph 2 trial for Waldenstrom macroglobulinemia mid-2024;top-line data mid-2026 | ||
MB-101 + | ▪ First-in-class combination of CAR-T therapy + an oncolytic virus for malignant brain tumors | |
MB-108 | ▪ Expect to file IND 4Q 2023 | |
In vivo | ▪ Novel platform to make CAR-Ts in the patient's own body - i.e., not in a manufacturing facility | |
CAR-T | ▪ Expect to publish first proof-of-concept data 4Q 2023 | |
MB-117 / | ▪ Transformational gene therapies for XSCID* (rare genetic disease) | |
3 | MB-217 | ▪ Phase 1 investigator IND trials with modified lentiviral vector expected to start 4Q 2023 |
* XSCID = X-linked severe combined immunodeficiency
Robust Pipeline of Therapies Addressing Highly Challenging Diseases
Therapeutic | Product (Target) | Pre-IND | Phase 1 | Registrational | |
Modality | Phase 2 | ||||
Hematologic CAR-T | MB-106 for NHL (including WM) & CLL (CD20) | Expect to disclose follow-up data from | |||
Mustang IND trial by year end 2023 | |||||
Combination CAR-T | MB-101CAR-T for GBM | COH first-in-human (FIH) MB-101 Phase 1 complete | |||
(IL13Rα2) | Combination | Expect MB-109 Mustang | |||
+ | |||||
= MB-109 | IND filing 4Q 2023 | ||||
oncolytic virus (OV) | |||||
MB-108 OV for GBM | |||||
UAB FIH MB-108 Phase 1 ongoing* | |||||
In vivo CAR-Ts | TBD | Publication expected | |||
4Q 2023 | |||||
Ex-vivoGene | MB-117 (modified vector) for newborn XSCID | ||||
(IL2RG) | Investigator IND trials | ||||
Therapy | |||||
MB-217 (modified vector) for previously | expected to start 4Q 2023 | ||||
transplanted XSCID (IL2RG) | |||||
CLL = Chronic lymphocytic leukemia | OV = Oncolytic virus | ||||
COH = City of Hope National Medical Center | UAB = University of Alabama at Birmingham | ||||
FIH = First-in-human | WM = Waldenstrom macroglobulinemia | ||||
GBM = Glioblastoma | XSCID = X-linked severe combined immunodeficiency | ||||
NIH = National Institutes of Health | * Partially or totally supported by grants` | ||||
4 | NHL = Non-Hodgkin lymphoma |
Leadership Team with Extensive Cell, Gene & Rare Disease Therapy Experience
Lynn E. Bayless, MS | Kerry Biron, BBA | Richard Bodmer, MS | Bruce Dezube, MD | James Edinger, PhD | Greg Furrow, MS, FRQA |
VP & Head, | VP & Head, | Head of CMC | Senior VP & Head, | Senior VP & Head, | Chief Quality Officer |
Regulatory Affairs | Clinical Operations | Development | Clinical Development | Preclinical Sciences |
Eliot Lurier, CPA | Manuel Litchman, MD | Debra Manning, SPHR | Robert Sexton, MS, MBA | Matthew Wein, JD |
Ad interim CFO | President & Chief | Senior VP & Head, | VP & Head, Program & | Vice President & |
Executive Officer | Human Resources | Alliance Leadership | General Counsel |
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Mustang Bio Inc. published this content on 13 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 October 2023 13:30:25 UTC.