Announcement • Apr 18
Mustang Bio, Inc. Receives Notice of Non-Compliance with Nasdaq Listing Rule On April 15, 2026, Mustang Bio, Inc. (the Company) received a notice from the Listing Qualifications Department (the Staff) of The Nasdaq Stock Market LLC (Nasdaq) indicating that the bid price of the Company's common stock, par value $0.0001 per share (Common Stock), had closed below $1.00 per share for 30 consecutive business days and, as a result, the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), which sets forth the minimum bid price requirement for continued listing on the Nasdaq Capital Market. The Staff notice has no immediate effect on the listing of the Company's Common Stock on Nasdaq. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company was afforded a 180-calendar day grace period, or until October 12, 2026, to regain compliance with the bid price requirement. Compliance can be achieved by evidencing a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days (but generally not more than 20 consecutive business days) during the 180-calendar day grace period. If the Company does not regain compliance with the bid price requirement by October 12, 2026, the Company may be eligible for an additional 180-calendar day compliance period so long as it satisfies the criteria for initial listing on The Nasdaq Stock Market and the continued listing requirement for market value of publicly held shares and the Company provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company is not eligible for the second grace period, Nasdaq staff will provide written notice that the Company's Common Stock is subject to delisting; however, the Company may request a hearing before the Nasdaq Hearings Panel (the Panel), which request, if timely made, would stay any further suspension or delisting action by the Staff pending the conclusion of the hearing process and expiration of any extension that may be granted by the Panel. There can be no assurance that the Company would be successful in its efforts to maintain the Nasdaq listing. The Company intends to closely monitor the closing bid price of its Common Stock and consider all available options to remedy the bid price deficiency, but no decision regarding any action has yet been made. Announcement • Dec 04
Mustang Bio, Inc., Annual General Meeting, Dec 22, 2025 Mustang Bio, Inc., Annual General Meeting, Dec 22, 2025. Announcement • Mar 06
Mustang Bio Regains Compliance with Nasdaq Capital Market Requirement Mustang Bio, Inc. announced that it has received notice from The Nasdaq Stock Market LLC (“Nasdaq”) informing the Company that it has regained compliance with the Nasdaq Capital Market’s minimum stockholders’ equity requirement as required by Nasdaq Listing Rule 5550(b)(1). On February 26, 2025, Mustang received formal notice from Nasdaq confirming that the Company has satisfied the minimum stockholders’ equity requirement as set in Nasdaq Listing Rule 5550(b)(1). As previously disclosed, the Company regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. Therefore, Mustang now meets all Nasdaq Capital Market listing requirements for continued listing, and the matters are now closed. Announcement • Feb 28
Mustang Bio, Inc. Anticipates Supporting and Initiating A Novel Clinical Trial with MB-109 Mustang Bio, Inc. expects to continue to rely on its academic partners and future contract manufacturing relationships to support clinical trials. As a result of the termination of its lease, the Company expects savings of approximately $2.0 million of cash expenses related to the lease over the next 24 months. The Company remains focused on advancing its existing portfolio and anticipates supporting and initiating a novel clinical trial with MB-109, a combination therapy of MB-108 (HSV-1 oncolytic virus) and MB-101 (IL13Ra2-targeted CAR-T cell therapy) for the treatment of recurrent glioblastoma (“GBM”) and high-grade astrocytomas in the second half of 2025. About MB-109 (MB-101 (IL13Ra2targeted CAR-T cells) + MB-108 oncolytic virus): MB-109 is Mustang’s designation for the treatment regimen combining MB-101 (IL13Ra2-targeted CAR-T cell therapy licensed from City of Hope) with MB-108 (HSV-1 oncolytic virus licensed from Nationwide Children’s Hospital). The combination is designed to leverage MB-108 to make immunologically “cold” tumors “hot” and potentially improve the efficacy of MB-101 CAR-T cell therapy. MB-108 oncolytic virus is first injected to infect tumor cells which, in turn, leads to reshaping of the tumor microenvironment (“TME”) through recruitment of endogenous CD8- and CD3-positive effector T-cells. This inflamed TME potentially permits MB-101 CAR-T cells injected into and around the tumor to better infiltrate into and throughout the tumor mass, undergo activation and, ideally, effect tumor cell killing. Announcement • Feb 12
Mustang Bio Regains Compliance with Nasdaq Minimum Bid Price Requirement Mustang Bio, Inc. announced that it has received notice from The Nasdaq Stock Market LLC (“Nasdaq”) informing the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. In addition, as a result of the closing of the public offering announced by the Company on February 10, 2025, the Company believes that it has a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market as required by Nasdaq Listing Rule 5550(b)(1). The Company is awaiting a formal compliance determination from Nasdaq, however, and there can be no assurance that the Company will receive the determination. Announcement • Feb 10
Mustang Bio, Inc. has completed a Follow-on Equity Offering. Mustang Bio, Inc. has completed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 495,000
Price\Range: $3.01
Discount Per Security: $0.2107
Security Name: Pre-funded Warrants
Security Type: Equity Warrant
Securities Offered: 2,162,807
Price\Range: $3.01
Discount Per Security: $0.2107
Security Name: Series C-1 Warrants
Security Type: Equity Warrant
Securities Offered: 2,657,807
Security Name: Series C-2 Warrants
Security Type: Equity Warrant
Securities Offered: 2,657,807 Announcement • Jan 16
Mustang Bio, Inc. has filed a Follow-on Equity Offering. Mustang Bio, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-funded Warrants
Security Type: Equity Warrant
Security Name: Series C-1 Warrants
Security Type: Equity Warrant
Security Name: Series C-2 Warrants
Security Type: Equity Warrant
Security Name: Series C-3 Warrants
Security Type: Equity Warrant Announcement • Dec 09
Mustang Bio, Inc., Annual General Meeting, Dec 26, 2024 Mustang Bio, Inc., Annual General Meeting, Dec 26, 2024. Announcement • Sep 14
Listing Qualifications Department of Nasdaq Determines to Delist the Mustang Bio's Securities from Nasdaq As previously disclosed, on May 16, 2024, the Staff of the Listing Qualifications Department (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") granted Mustang Bio, Inc. (the Company") an extension through September 9, 2024, to regain compliance with the $2.5 million stockholders' equity requirement for continued listing on The Nasdaq Capital Market, as set in Nasdaq Listing Rule 5550(b) (the Rule"). The Company was unable to demonstrate compliance with the Rule by that date. Accordingly, on September 10, 2024, the Staff formally notified the Company that it had determined to delist the Company's securities from Nasdaq based upon the Company's continued non-compliance with the Rule unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the Panel"). The Company intends to timely request a hearing before the Panel, which request will stay any further action by Nasdaq at least pending completion of the hearing and the expiration of any extension that may be granted by the Panel to the Company following the hearing. The Company is considering all options available to it to regain compliance with the Rule; however, there can be no assurance that the Panel will grant the Company's request for continued listing or that the Company will be able to evidence compliance with the Rule within any extension period that may be granted by the Panel. Neither the Staff's notification nor the Company's noncompliance with the Rule have an immediate effect on the listing or trading of the Company's common stock, par value $0.0001 per share, which will continue to trade on The Nasdaq Capital Market under the symbol MBIO". New Risk • Sep 12
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.87m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$27m free cash flow). Share price has been highly volatile over the past 3 months (61% average daily change). Negative equity (-US$8.3m). Shareholders have been substantially diluted in the past year (355% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.87m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$22m net loss next year). New Risk • Aug 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$27m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$27m free cash flow). Share price has been highly volatile over the past 3 months (62% average daily change). Negative equity (-US$8.3m). Shareholders have been substantially diluted in the past year (327% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$22m net loss next year). Market cap is less than US$100m (US$11.5m market cap). New Risk • Aug 06
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.52m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (62% average daily change). Negative equity (-US$4.9m). Shareholders have been substantially diluted in the past year (329% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.52m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$21m net loss next year). Announcement • Jun 21
Mustang Bio, Inc. has filed a Follow-on Equity Offering in the amount of $2.51299 million. Mustang Bio, Inc. has filed a Follow-on Equity Offering in the amount of $2.51299 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,025,000
Price\Range: $0.41
Discount Per Security: $0.0287
Security Name: Pre Funded Warrants
Security Type: Equity Warrant
Securities Offered: 3,105,000
Price\Range: $0.4099
Discount Per Security: $0.0287
Transaction Features: Registered Direct Offering Announcement • Jun 20
Mustang Bio, Inc. has completed a Follow-on Equity Offering in the amount of $5.6 million. Mustang Bio, Inc. has completed a Follow-on Equity Offering in the amount of $5.6 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Announcement • Jun 18
Mustang Bio, Inc. Announces Favorable Efficacy and Safety Data from Complete Waldenstrom Macroglobulinemia Cohort of Phase 1/2 Clinical Trial of Mb-106, Cd20-Targeted Autologous Car-T Therapy Mustang Bio, Inc. announced that updated data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T-cell therapy, show a favorable safety and efficacy profile in patients with Waldenstrom macroglobulinemia, a rare form of blood cancer. MB-106 is being developed in a collaboration between Mustang and Fred Hutch Cancer Center to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHLs”) and chronic lymphocytic leukemia. The updated results from the single-institution Phase 1/2 clinical trial were presented during a poster session at the European Hematology Association 2024 Hybrid Congress (“EHA2024”) by Brian Till, M.D., Associate Professor and physician at Fred Hutch and University of Washington. All ten patients in the study were previously treated with Bruton's tyrosine kinase inhibitors (“BTKi”), and their disease continued to progress while on BTKi. Overall, 90% (9/10) of the patients treated with MB-106 responded to treatment, including 3 complete responses, 2 very good partial responses and 4 partial responses. In addition, 1 patient experienced stable disease. One of the patients who achieved a complete response has remained in remission for 31 months, with an immunoglobulin M (IgM) level that decreased rapidly to the normal range after treatment with MB-106 and has remained normal since. Patients had a median of nine prior lines of therapy and only one patient has started additional anti-WM treatment after being treated with MB-106. From a safety perspective, cytokine release syndrome (CRS) occurred in nine patients: five patients with grade 1 and four patients with grade 2. One patient experienced grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS). No grade 3 or 4 CRS or grade 2, 3 or 4 ICANS has been observed, despite dose escalation. Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and its scientists may benefit financially from this work in the future. The Company’s ability to further develop the MB-106 program for hematologic malignancies is contingent upon raising a significant amount of additional funding and /or consummating a strategic partnership. New Risk • May 23
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 53% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Negative equity (-US$4.9m). Shareholders have been substantially diluted in the past year (53% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.99m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$22m net loss next year). Announcement • May 22
Mustang Bio Receives Notice from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirement Under Nasdaq Listing Rule 5550(a)(2) for Continued Listing on the Nasdaq Capital Market On May 16, 2024, Mustang Bio, Inc. (the ‘Company’) received a notice (the ‘Second Letter’) from the Listing Qualifications Department (the ‘Staff’) of The Nasdaq Stock Market LLC (‘Nasdaq’) indicating that the bid price of the Company’s common stock, par value $0.0001 per share (‘Common Stock’), had closed below $1.00 per share for 31 consecutive business days and, as a result, the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), which sets the minimum bid price requirement for continued listing on the Nasdaq Capital Market. The Second Letter from Nasdaq has no immediate effect on the listing of the Company’s Common Stock on Nasdaq. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company was afforded a 180-calendar day grace period, or until November 12, 2024, to regain compliance with the bid price requirement. Compliance can be achieved by evidencing a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days (but generally not more than 20 consecutive business days) during the 180-calendar day grace period. If the Company does not regain compliance with the bid price requirement by November 12, 2024, the Company may be eligible for an additional 180-calendar day compliance period so long as it satisfies the criteria for initial listing on The Nasdaq Stock Market and the continued listing requirement for market value of publicly held shares and the Company provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company is not eligible for the second grace period, Nasdaq staff will provide written notice that the Company’s Common Stock is subject to delisting; however, the Company may request a hearing before the Nasdaq Hearings Panel (the ‘Panel’), which request, if timely made, would stay any further suspension or delisting action by the Staff pending the conclusion of the hearing process and expiration of any extension that may be granted by the Panel. There can be no assurance that the Company would be successful in its efforts to maintain the Nasdaq listing. The Company intends to closely monitor the closing bid price of its Common Stock and consider all available options to remedy the bid price deficiency, but no decision regarding any action has yet been made. Price Target Changed • May 14
Price target decreased by 43% to US$10.00 Down from US$17.50, the current price target is provided by 1 analyst. New target price is 3,623% above last closing price of US$0.27. Stock is down 94% over the past year. The company is forecast to post a net loss per share of US$0.65 next year compared to a net loss per share of US$6.00 last year. New Risk • Apr 04
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 3.7% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$8.47m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$55m net loss in 2 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Announcement • Mar 28
Mustang Bio, Inc Announces Vision for CAR T-Cell Therapy Platform Expansion into Autoimmune Diseases Mustang Bio, Inc. announced its expansion into autoimmune diseases with MB-106, a personalized CD20-targeted, 3rd-generation autologous CAR T-cell therapy. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”). Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases. This expansion is supported by promising scientific evidence. Several antibody therapies targeting CD20 on B-cells have successfully transitioned from cancer to autoimmune diseases, such as rituximab for both lymphoma and rheumatoid arthritis. Additionally, clinical studies with CAR-T therapies have already demonstrated early success in the treatment of autoimmune conditions, with published reports showing remission in patients with refractory systemic lupus erythematosus and other autoimmune diseases. MB-106 is currently in a Mustang-sponsored multicenter Phase 1/2 clinical trial for relapsed or refractory B-cell non-Hodgkin lymphomas (“NHL”) and chronic lymphocytic leukemia (“CLL”). Mustang expects to enroll the first patient in a registrational study evaluating MB-106 for Waldenstrom macroglobulinemia (“WM”), a rare type of B-Cell NHL, in the second half of this year. Announcement • Mar 18
Mustang Bio Receives Deficiency Letter from Nasdaq Due to Non-Compliance with the Minimum Stockholders’ Equity Requirement Under Nasdaq Listing Rule 5550(b)(1) On March 13, 2024, Mustang Bio, Inc. (the ‘Company’) received a deficiency letter (the ‘Letter’) from the Listing Qualifications Department (the ‘Staff’) of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that it was not in compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1). Nasdaq Listing Rule 5550(b)(1) requires companies listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 (the ‘Stockholders’ Equity Requirement’). The Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, reported stockholders’ equity of $123,000. The Letter further noted that as of its date, the Company did not have a market value of listed securities of $35 million, or net income from continued operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years, the alternative quantitative standards for continued listing on the Nasdaq Capital Market. The Letter has no immediate effect on the Company’s continued listing on the Nasdaq Capital Market, subject to the Company’s compliance with the other continued listing requirements. In accordance with Nasdaq rules, the Company has been provided 45 calendar days, or until April 29, 2024, to submit a plan to regain compliance (the ‘Compliance Plan’). If the Compliance Plan is acceptable to the Staff, it may grant an extension of 180 calendar days from the date of the Letter. If the Staff does not accept the Compliance Plan, the Staff will provide written notification to the Company that the Compliance Plan has been rejected. At that time, the Company may appeal the Staff’s determination to a Nasdaq Hearings Panel. The Company intends to submit a Compliance Plan on or before April 29, 2024. Further, the Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. However, there can be no assurance that Nasdaq will approve the Compliance Plan or that the Company will ultimately regain compliance with all applicable requirements for continued listing. Neither the Letter nor the Company’s noncompliance have an immediate effect on the listing or trading of the Company’s common stock, which will continue to trade on the Nasdaq Capital Market under the symbol ‘MBIO’. New Risk • Mar 17
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.81m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 3.7% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$9.81m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$55m net loss in 2 years). Shareholders have been diluted in the past year (27% increase in shares outstanding). Announcement • Mar 16
Mustang Bio, Inc. has filed a Follow-on Equity Offering in the amount of $10.5 million. Mustang Bio, Inc. has filed a Follow-on Equity Offering in the amount of $10.5 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Warrants
Security Type: Equity Warrant
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant New Risk • Mar 12
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$50m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$50m free cash flow). Earnings are forecast to decline by an average of 22% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$80m net loss in 2 years). Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (US$10.6m market cap). Announcement • Mar 07
Mustang Bio, Inc. Announces Publication in Nature Medicine of Data from Phase 1 Trial Evaluating MB-101IL13Ra2-targeted CAR T-Cells in High-Grade Glioma Mustang Bio, Inc. announced Phase 1 clinical data were published in Nature Medicine that demonstrated the promising safety and clinical activity of Mustang's MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of patients with recurrent and refractory malignant glioma, including glioblastoma. MB-101 was developed by City of Hope, one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Mustang. Highlights from the data include: Stable disease or better was achieved in 50% (29/58) of heavily pretreated patients for at least two months, with two partial responses, one complete response (CR), and a second CR after additional CAR-T cycles under compassionate use; Patients with recurrent GBM treated in the final cohort with dual intratumoral (ICT)/intraventricular (ICV) delivery and an optimized manufacturing process exhibited superior median overall survival of 10.2 months, compared to the expected survival rate of six months in patients with recurrent GBM. The median overall survival for all patients was eight months; Intermediate/high pre-treatment tumor T-cell levels that are indicative of a “hot” tumor microenvironment (TME) correlated with a significant survival benefit over negative/low pre-treatment tumor T-cell levels that are indicative of a “cold” TME; Overall, all routes of delivery (ICT, ICV and dual ICT?+?ICV) were well-tolerated at doses up to 200×106 CAR?T-cells; Central nervous system (CNS) increases in inflammatory cytokines, including IFN?, CXCL9, and CXCL10, were associated with CAR T-cell administration and bioactivity. The data reported on 65 patients with recurrent high-grade glioma, the majority being glioblastoma (GBM; 2?+?recurrences); 58 patients were evaluable for disease response. Primary endpoints were safety and feasibility, with secondary endpoints measuring therapy-related cytokine dynamics, CAR T-cell persistence and clinical outcomes. Patients were treated at one of three dose schedules with three weekly infusions administered without prior lymphodepleting chemotherapy and were evaluated one week after the third cycle for dose limiting toxicities. Additional infusions were allowed, and patients were followed for toxicities, response, and survival until they progressed or required subsequent therapy. This study evaluated five treatment arms: Arm 1, intratumoral following biopsy (ICT Biopsy); Arm 2, intratumoral following maximal surgical resection (ICT Resection); Arm 3, intraventricular (ICV); and Arms 4 and 5, combined ICT and ICV delivery (Dual ICT?+?ICV). ICV delivery (Arm 3) was added after trial initiation based on clinical experience, in which IL13Ra2-CAR T-cells that were administered ICV mediated a complete response in a patient with multifocal recurrent GBM, and preclinical data suggested ICV was more effective against multifocal tumors. Subsequently, City of Hope transitioned to dual delivery combining both ICV and ICT (Arms 4–5) – rather than continuing with ICV alone – as preclinical data also suggested that intratumoral delivery was more effective for defined unifocal tumors in comparison to ICV-only delivery. Weekly ICT and/or ICV administration of IL13Ra2-CAR T-cells was well-tolerated, with clinically manageable adverse events. No high-grade cytokine release syndrome or immune effector cell-mediated neurotoxicity adverse events were observed, and no dose limiting toxicities (DLTs) were noted during the 28-day dose limiting toxicity period. The most common toxicities with possible or higher attribution to CAR T-cells were fatigue, headache, and hypertension. Grade 3 and above toxicities with possible or higher attribution to CAR T-cells were seen in 35% of patients, including two incidences of transient grade 4 cerebral edema with possible attribution to CAR T-cells and one grade 3 encephalopathy and one grade 3 ataxia with probable attribution to CAR T-cells. Price Target Changed • Nov 16
Price target decreased by 29% to US$13.00 Down from US$18.25, the current price target is an average from 2 analysts. New target price is 713% above last closing price of US$1.60. Stock is down 79% over the past year. The company is forecast to post a net loss per share of US$6.04 next year compared to a net loss per share of US$11.24 last year. Announcement • Nov 04
Mustang Bio, Inc. announced that it has received $4.742942 million in funding On November 3, 2023, Mustang Bio, Inc. closed the transaction. The transaction included participation from a single investor. In connection with the offering, the placement agent received is $308,000.08 and warrants to purchase up to 155,294 shares of common stock exercisable at $2.125 per share. New Risk • Nov 01
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 9.4% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$63m free cash flow). Earnings are forecast to decline by an average of 4.2% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$71m net loss in 2 years). Share price has been volatile over the past 3 months (9.4% average weekly change). Shareholders have been diluted in the past year (17% increase in shares outstanding). Market cap is less than US$100m (US$15.1m market cap). Announcement • Oct 31
Mustang Bio, Inc. has completed a Follow-on Equity Offering in the amount of $4.398333 million. Mustang Bio, Inc. has completed a Follow-on Equity Offering in the amount of $4.398333 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 920,000
Price\Range: $1.7
Discount Per Security: $0.119
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,668,236
Price\Range: $1.699
Discount Per Security: $0.11893
Transaction Features: Registered Direct Offering New Risk • Oct 30
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 4.2% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$63m free cash flow). Earnings are forecast to decline by an average of 4.2% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$71m net loss in 2 years). Shareholders have been diluted in the past year (4.1% increase in shares outstanding). Market cap is less than US$100m (US$12.3m market cap). Announcement • Oct 27
Mustang Bio, Inc. Announces FDA Acceptance of IND Application for MB-109, A Novel Combination of MB-101 (IL13RA2-Targeted Car-T Cell Therapy) and MB-108 (HSV-1 Oncolytic Virus), for the Treatment of Recurrent Glioblastoma and High-Grade Astrocytoma Mustang Bio, Inc. announced that the U.S. Food and Drug Administration ("FDA") has accepted the Company's Investigational New Drug ("IND") application of MB-109 for the treatment of recurrent glioblastoma ("GBM") and high-grade astrocytoma. Mustang is planning to initiate a Phase 1 multicenter clinical trial at City of Hope ("COH") and the University of Alabama at Birmingham ("UAB") to assess the safety, tolerability and efficacy of MB-109, a novel combination of MB-101 (COH-developed IL13Ra2-targeted CAR-T cell therapy) and MB-108 [Nationwide Children's Hospital- ("Nationwide") developed HSV-1 oncolytic virus] in adult patients with recurrent GBM and high-grade astroCytomas that express IL13Ra2 on the surface of the tumor cells. As previously reported, preclinical data presented at the American Association for Cancer Research ("AACR") Annual Meeting in 2022 supported this combination therapy to potentially optimize results to treat recurrent GBM. The combination leverages MB-108 to reshape the tumor microenvironment ("TME") and make cold tumors "hot," thereby potentially improving the efficacy of MB-101 CAR-T cell therapy. Data presented separately on MB-101 and MB-108 showed that administration of these therapies was well tolerated in recurrent GBM patients. Phase 1 clinical trials of MB-101 at COH and of MB-108 at UAB continue to enroll patients. R risks and uncertainties 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, 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; dependence on third-party suppliers; ability to attract, integrate and retain key personnel; the early stage of products under development; need for substantial additional funds; government regulation; patent and regulatory approvals; patent and regulatory approvals and regulatory approvals. Announcement • Aug 17
Mustang Bio, Inc. Announces First Data from Ongoing Multicenter Phase 1/2 Clinical Trial Evaluating MB-106 CAR-T Cell Therapy Mustang Bio, Inc. (Mustang or the Company) announced the first data from the indolent lymphoma cohort of the Company’s ongoing multicenter Phase 1/2 clinical trial evaluating MB-106, a first-in-class CD20-targeted, autologous CAR-T cell therapy for the treatment of relapsed or refractory B-cell non-Hodgkin lymphomas (B-NHL) and chronic lymphocytic leukemia (CLL), demonstrating clinical responses as well as safety and efficacy consistent with the ongoing Phase 1/2 clinical trial taking place at Fred Hutchinson Cancer Center (Fred Hutch). Initial data were presented by Mazyar Shadman, M.D., M.P.H., Study Chair, Associate Professor and physician at Fred Hutch and University of Washington, at the 5th International Workshop on CAR-T and Immunotherapies (iwCAR-T). The multicenter study data show clinical responses in four of four patients with relapsed or refractory indolent NHL at the starting dose of 3.3 x 106 CAR-T cells/kg, a dose comparable to that employed for the majority of the indolent lymphoma patients in the Fred Hutch trial. The multicenter data also show persistence of CAR-T cells at 6+ months and favorable safety data with only Grade 1 cytokine release syndrome (CRS) reported to date. Two patients with follicular lymphoma had complete response (CR) by both PET-CT and bone marrow, one of whom had been previously treated with a CD19-directed CAR-T. A third patient, with a diagnosis of Waldenstrom macroglobulinemia (WM), who had nine prior treatments and high disease burden, achieved complete metabolic response by PET-CT, morphologic clearance of lymphoma in bone marrow, and resolution of the IgM monoclonal protein. The fourth patient, with a diagnosis of hairy cell leukemia variant, who had been heavily transfusion dependent, continues to have stable disease with decreased disease in his bone marrow and achieved complete transfusion independence, which is ongoing at 6+ months. Following treatment of the four indolent NHL patients, the Safety Review Committee unanimously approved dose escalation to 1.0 x 107 CAR-T cells/kg. The five-center Phase 1/2 clinical trial is a three-arm study targeting CLL and B-NHL, including FL, diffuse large B-cell lymphoma and mantle cell lymphoma. We anticipate adding a sixth center by the end of 2023. The Mustang-sponsored multicenter clinical trial is using the same lentiviral vector as the Fred Hutch-sponsored single-center trial. Included in the eligibility criteria are patients who have relapsed after treatment with CD19 CAR-T cell therapy. Additionally, the FL arm will evaluate other indolent histologies including Waldenstrom macroglobulinemia, a rare type of B-NHL for which the U.S. Food and Drug Administration granted MB-106 Orphan Drug Designation. Patients will be enrolled in one of three arms, based on their primary diagnosis; escalating MB-106 dose levels will be tested independently in each arm using a 3+3 design. A total of up to 18 patients are anticipated to be treated in each Phase 1 arm, including six patients at the maximum tolerated dose in each independent arm. Safety of each dose level will be reviewed for each arm until the maximum tolerated dose has been reached and the recommended Phase 2 dose (RP2D) has been established for each arm. An assessment of the safety and tolerability of the dose will be made by the Safety Review Committee based on the data from the 28-day dose-limiting toxicity observation period. In Phase 2, specific arms of relapsed or refractory CD20-positive B-cell hematologic malignancies will be treated with MB-106 at the respective RP2D for each arm. The two top priorities are WM and diffuse large B-cell lymphoma (DLBCL) relapsed from prior CD19 CAR-T therapy. Each arm will initially include up to 20 patients. Based on the results of the interim analysis, up to an additional 51 patients may be added to each of the arms. Announcement • Aug 01
uBriGene (Boston) Biosciences Inc. completed the acquisition of Worcester manufacturing facility of Mustang Bio, Inc. uBriGene (Boston) Biosciences Inc. entered into asset purchase agreement to acquire Worcester manufacturing facility of Mustang Bio, Inc. for $11 million on May 18, 2023. The consideration includes $6 million payable upfront plus an additional $5 million payable upon Mustang raising $10 million in gross proceeds from equity raises following the closing of the transaction. The closing of the transaction is subject to the satisfaction of certain conditions, including approval of transfer of the Company’s lease to uBriGene by the owner of the building and the acceptance of offers of employment with uBriGene or its affiliates by certain key current Mustang employees. Subject to satisfaction of conditions, the Company expects the transactions to close in June 2023. If the Asset Purchase Agreement is terminated due to either party’s willful material breach, inaccuracy in or failure to perform any representation, warranty, covenant or agreement made pursuant to the Asset Purchase Agreement, such party shall pay $1 million to the other party within 30 days of such termination. As on June 30, 2023, Mustang Bio and uBriGene amended the Asset Purchase Agreement, under which the parties have extended the outside date by 30 days and the amended outside date is July 31, 2023.uBriGene (Boston) Biosciences Inc. completed the acquisition of Worcester manufacturing facility of Mustang Bio, Inc. on July 31, 2023. Announcement • Jun 16
Mustang Bio Announces Final Results from Follicular Lymphoma Cohort of Single-Institution Phase 1/2 Clinical Trial of MB-106, CD20-Targeted Autologous CAR T Therapy Mustang Bio, Inc. announced that final data from the follicular lymphoma (“FL”) cohort of the single-institution Phase 1/2 clinical trial of MB-106 demonstrate treatment with the CD20-targeted, autologous CAR T-cell therapy resulted in high overall response (“ORR”) and complete response (“CR”) rates and CAR T persistence in FL patients. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”) to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHLs”) and chronic lymphocytic leukemia (“CLL”). The final FL cohort results from the Phase 1/2 clinical trial being conducted at Fred Hutch were presented by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutch and University of Washington, at the 17thInternational Conference on Malignant Lymphoma (“17-ICML”). A total of 20 patients with relapsed FL with confirmed CD20 expression participated in the study and had day 28 assessment. Median age was 63 years (range: 44 – 81), and median prior lines of treatment was 4 (range: 1 – 12). High-risk features included patients with progression of disease within 24 months of first-line chemoimmunotherapy (POD24) (n=15; 75%), history of histologic transformation (n=4, 20%), prior treatment with a CD19 target CAR T (n=1, 5%). ORR was 95% (19/20), and CR rate was 80% (16/20). Patients who received higher dose levels (3.3 x 106 and 1.0 x 107 cells/kg) had an ORR of 100% and a CR rate of 91%. Ten patients are in remission over one year, seven of whom are over two years. One patient, previously treated with a CD19-targeted CAR T-cell therapy, achieved a CR and remains in remission after 18 months. From a safety profile perspective, all cytokine release syndrome (“CRS”) events were grade 1 (n=5; 25%) or grade 2 (n=1; 5%), with no grade = 3 CRS events. There was no occurrence of immune effector cell-associated neurotoxicity syndrome of any grade. Major Estimate Revision • May 25
Consensus EPS estimates upgraded to US$5.61 loss The consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$38.89 to -US$5.61 per share. Revenue forecast unchanged from US$1.50m at last update. Biotechs industry in the US expected to see average net income decline 88% next year. Consensus price target down from US$62.75 to US$40.75. Share price rose 11% to US$4.88 over the past week. Price Target Changed • May 24
Price target decreased by 35% to US$40.75 Down from US$62.75, the current price target is an average from 4 analysts. New target price is 776% above last closing price of US$4.65. Stock is down 53% over the past year. The company is forecast to post a net loss per share of US$9.19 next year compared to a net loss per share of US$11.24 last year. Major Estimate Revision • May 22
Consensus EPS estimates fall by 286% The consensus outlook for fiscal year 2023 has been updated. 2023 expected loss increased from -US$10.02 to -US$38.72 per share. Revenue forecast of US$1.50m unchanged since last update. Biotechs industry in the US expected to see average net income decline 81% next year. Consensus price target of US$60.75 unchanged from last update. Share price fell 6.9% to US$4.05 over the past week. Price Target Changed • May 21
Price target increased by 20% to US$75.00 Up from US$62.75, the current price target is an average from 4 analysts. New target price is 1,752% above last closing price of US$4.05. Stock is down 62% over the past year. The company is forecast to post a net loss per share of US$55.12 next year compared to a net loss per share of US$11.24 last year. Announcement • May 19
uBriGene (Boston) Biosciences Inc. entered into asset purchase agreement to acquire Worcester manufacturing facility of Mustang Bio, Inc. for $11 million. uBriGene (Boston) Biosciences Inc. entered into asset purchase agreement to acquire Worcester manufacturing facility of Mustang Bio, Inc. for $11 million on May 18, 2023. The consideration includes $6 million payable upfront plus an additional $5 million payable upon Mustang raising $10 million in gross proceeds from equity raises following the closing of the transaction. The closing of the transaction is subject to the satisfaction of certain conditions, including approval of transfer of the Company’s lease to uBriGene by the owner of the building and the acceptance of offers of employment with uBriGene or its affiliates by certain key current Mustang employees. Subject to satisfaction of conditions, the Company expects the transactions to close in June 2023. Price Target Changed • Nov 16
Price target decreased to US$5.00 Down from US$7.00, the current price target is an average from 5 analysts. New target price is 862% above last closing price of US$0.52. Stock is down 77% over the past year. The company is forecast to post a net loss per share of US$0.76 next year compared to a net loss per share of US$0.76 last year. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. No highly experienced directors. Independent Director Michael Zelefsky was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Seeking Alpha • Sep 23
Mustang Bio: This Horse May Gallop Still Summary
We are circling back on small CAR-T developmental firm Mustang Bio, Inc. today for the first time in nearly a year and a half.
The stock has been under pressure since we last looked in on this story, and the shares currently trade for less than net cash on the company's balance sheet.
Mustang still has several interesting candidates within its advancing pipeline. An investment analysis follows in the paragraphs below.
Being born in a stable does not make one a horse. " - Duke of Wellington
We put the spotlight on Mustang Bio, Inc. (MBIO) today for the first time in nearly 18 months. When we last looked at this small biotech name in May of 2021, insiders were purchasing the shares and MBIO seems to merit a small covered call holding. Unfortunately, for shareholders and insiders, that bet has not paid off. So, is there any hope left for this developmental firm or is it a dead horse that deserves to be left alone? An analysis follows below.
Seeking Alpha
Mustang Bio Overview:
Mustang Bio, Inc. is a clinical-stage biopharmaceutical company based in Massachusetts. Mustang is focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. The stock currently sells for around a half a buck a share and sports an approximate market capitalization of $55 million.
August Company Presentation
The company is developing CAR-T therapies designed to be effective against multiple cancer types as well as lentiviral gene therapies for severe combined immunodeficiency.
August Company Presentation
As you can see above, the company has several efforts underway within its pipeline. We will focus on Mustang's two Ex-vivo Gene Therapies (MB-107 and MB-207) for the purposes of this article given they are the farthest along in development.
August Company Presentation
MB-207 is targeting a very rare affliction called X-linked severe combined immunodeficiency, or XSCID, and is a lentiviral gene therapy. This candidate has garnered both Orphan Drug and Rare Pediatric Disease Designations.
MB-107 is another ex vivo lentiviral gene therapy for X-linked SCID (“XSCID”) in newly diagnosed infants under the age of two. Management presented at the American Society of Gene & Cell Therapy 25th Annual Meeting in May. Data showed all 23 treated patients were alive at 2.6-year median follow-up without evidence of malignant transformation, and the treatment established a stable, functioning immune system in patients.
August Company Presentation
Mustang expects to enroll the first patient in a pivotal multicenter Phase 2 clinical trial under Mustang’s IND to evaluate MB-107 in 2023 and is targeting 2024 for topline data. The company filed an IND application in late 2021 for its pivotal multicenter Phase 2 clinical trial of MB-207. That trial is currently on hold pending CMC clearance from the FDA. Based on feedback, management expects to enroll the first patient in this pivotal study sometime in 2023.
August Company Presentation
In addition, interim Phase 1/2 clinical trial data around Mustang's drug candidate MB-106 were presented at several conferences during the Spring. MB-106 is a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell NHL and CLL. MB-106 has Orphan Drug designation for Waldenstrom macroglobulinemia [WM], a rare type of B-cell non-Hodgkin lymphomas [B-NHLs]. Data presented demonstrated high efficacy and a favorable safety profile across all patients with a wide range of hematologic malignancies with no cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome greater than grade 2. The first patient in a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL under Mustang’s IND should begin dosing shortly.
August Company Presentation
Analyst Commentary & Balance Sheet:
Since late April, four analyst firms including BTIG and B. Riley Financial have reissued Buy ratings on the stock. Price targets proffered range from $4 to $8 a share. Here is the view from Oppenheimer's analyst who maintained his Outperform rating on MBIO with $8 price target on April 26th.
New data from an academic-sponsored trial of Mustang’s CD20 CAR-T program (MB-106) were presented at the 2022 Tandem Meetings in Transplantation & Cellular Therapy (TCT) on Sunday. The presentation included safety and efficacy data from 25 patients—including five new patients since the last update at ASH. In our view, the maturing data point to dose-dependent efficacy across a broad range of heavily-pretreated B-NHL and CLL patients. The ORR/CR rates across all tumor histologies were 96% and 72%, respectively (vs. 95% and 65% at ASH), with no ≥Grade 3 CRS or neurotox. Mustang plans to initiate a multicenter, company-sponsored Phase 1 trial in 2Q, and we continue to view MB-106 as an attractive potential alternative to currently approved CD19 CAR-T products" Price Target Changed • May 13
Price target decreased to US$7.40 Down from US$8.40, the current price target is an average from 5 analysts. New target price is 970% above last closing price of US$0.69. Stock is down 75% over the past year. The company is forecast to post a net loss per share of US$0.80 next year compared to a net loss per share of US$0.76 last year. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. No highly experienced directors. Independent Director Michael Zelefsky was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Price Target Changed • Jan 25
Price target decreased to US$8.40 Down from US$10.40, the current price target is an average from 5 analysts. New target price is 546% above last closing price of US$1.30. Stock is down 71% over the past year. The company is forecast to post a net loss per share of US$0.73 next year compared to a net loss per share of US$1.14 last year. Price Target Changed • Nov 17
Price target decreased to US$9.80 Down from US$10.75, the current price target is an average from 4 analysts. New target price is 322% above last closing price of US$2.32. Stock is down 23% over the past year. The company is forecast to post a net loss per share of US$0.73 next year compared to a net loss per share of US$1.14 last year. Recent Insider Transactions • Aug 06
President recently bought US$251k worth of stock On the 30th of July, Manuel Litchman bought around 86k shares on-market at roughly US$2.91 per share. This was the largest purchase by an insider in the last 3 months. Manuel has been a buyer over the last 12 months, purchasing a net total of US$1.1m worth in shares.