Core Points - Mustang Bio, Inc. has regained compliance with Nasdaq's minimum bid price requirement for continued listing [1] - The company believes it has at least $2.5 million in stockholders' equity following a public offering, meeting Nasdaq's continued listing requirement [2] - Mustang Bio is a clinical-stage biopharmaceutical company focused on cell therapies for difficult-to-treat cancers, partnering with leading medical institutions for CAR-T therapy development [3]

Core Insights - Mustang Bio, Inc. announced that the FDA granted Orphan Drug Designation for MB-108, a herpes simplex virus type 1 (HSV-1) oncolytic virus, for the treatment of malignant glioma, which could provide additional market exclusivity [1][3] - The company is advancing a novel combination therapy of MB-108 and MB-101 (IL13Rα2-targeted CAR-T cell therapy) aimed at improving treatment outcomes for patients with recurrent glioblastoma and high-grade astrocytomas [1][3] - Preclinical data supports the combination therapy's potential to reshape the tumor microenvironment, making cold tumors "hot" and enhancing the efficacy of CAR-T cell therapy [3][5] Company Overview - Mustang Bio is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers, aiming to translate medical breakthroughs into potential cures [6] - The company has partnered with leading medical institutions to advance CAR-T therapies and is actively seeking to raise additional funding or form strategic partnerships to further develop its programs [4][6] Clinical Development - The ongoing Phase 1 clinical trials for MB-101 and MB-108 are enrolling patients, with previous data indicating that the therapies were well tolerated in patients with recurrent glioblastoma [3][5] - The combination therapy aims to leverage MB-108 to enhance the infiltration and activation of MB-101 CAR-T cells within the tumor mass, potentially leading to improved tumor cell killing [5]

Core Viewpoint - Mustang Bio, Inc. has entered into a definitive agreement to exercise existing warrants for the purchase of 16,877,638 shares of common stock at an exercise price of $0.237 per share, expected to generate approximately $4 million in gross proceeds [1][2]. Group 1: Financial Details - The exercise of existing warrants will result in the issuance of new unregistered warrants to purchase up to 33,755,276 shares of common stock at an exercise price of $0.27 per share [2]. - The new warrants will have a term of five years for 16,877,638 shares and a term of twelve months for the remaining shares from the date of stockholder approval [2]. - The offering is anticipated to close on or about October 25, 2024, subject to customary closing conditions [2]. Group 2: Regulatory and Compliance - The new warrants and the shares of common stock issuable upon their exercise are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933 and Regulation D [3]. - The company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon the exercise of the new warrants [3]. Group 3: Company Overview - Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers [5]. - The company aims to acquire rights to innovative technologies through licensing or ownership interests to fund research and development [5]. - Mustang has partnered with leading medical institutions to advance CAR-T therapies [5].

Clinical Development - The company is focused on developing CAR T therapies for hematologic malignancies and solid tumors, partnering with institutions like Fred Hutch and City of Hope[99] - As of December 2023, approximately 40 patients have been treated in an ongoing Phase 1 clinical trial for MB-106, with a favorable safety profile and complete response rate[102] - The FDA accepted the IND application for MB-109 in October 2023, allowing the initiation of a Phase 1 study for patients with IL13Rα2+ recurrent glioblastoma[104] - The overall complete response rate for follicular lymphoma in the Phase 1 trial was sustained at 100% with no occurrences of severe CRS[106] - The company plans to initiate a proof-of-concept trial for MB-106 in autoimmune diseases in Q4 2024, with results anticipated in 2025[110] - The FDA granted RMAT designation for MB-106, expediting its development and review process[107] Financial Performance - The company has incurred substantial operating losses since inception and expects to continue incurring significant losses for the foreseeable future[112] - The company reported stockholders' equity of $123,000 as of December 31, 2023, and negative stockholders' equity of $(8.3) million as of June 30, 2024, failing to meet Nasdaq's minimum requirement of $2.5 million[125] - A public offering in May 2024 raised approximately $3.2 million, with shares sold at $0.237 each, alongside various warrants[131] - The company entered into a Securities Purchase Agreement for a registered direct offering on June 21, 2024, raising approximately $2.1 million at a price of $0.41 per share[134] - The May 2024 Offering included 1,160,000 shares of common stock and multiple series of warrants, with the public offering price set at $0.237 per share[128] - The company was granted a 180-day extension until September 9, 2024, to regain compliance with Nasdaq's stockholders' equity requirement[125] - The company reported a net loss of $13.4 million for the six months ended June 30, 2024, which is a 59% improvement compared to a net loss of $32.9 million in 2023[167] - Cash and cash equivalents as of June 30, 2024, were $4.3 million, with an accumulated deficit of $394.4 million[162] - Net cash used in operating activities was $7.7 million for the six months ended June 30, 2024, significantly lower than $30.2 million in 2023[167] - The company raised approximately $5.3 million from equity offerings completed in May and June 2024[162] Cost Management - The company announced a workforce reduction of approximately 81% in April 2024 to reduce costs and preserve capital[113] - Research and development expenses for Q2 2024 were $4.36 million, a decrease of 60% from $10.84 million in Q2 2023[148] - Total operating expenses for Q2 2024 were $8.54 million, down 39% from $13.89 million in Q2 2023[148] - General and administrative expenses decreased to $1.53 million in Q2 2024 from $3.05 million in Q2 2023, reflecting a 50% reduction[148] - Research and development expenses for the six months ended June 30, 2024, totaled $8.2 million, down 67% from $24.8 million in the same period of 2023[156] - Total operating expenses for the six months ended June 30, 2024, were $13.8 million, a decrease of 54% compared to $30.2 million for the same period in 2023[157] - General and administrative expenses were $3.0 million for the six months ended June 30, 2024, a reduction of 45% from $5.4 million in 2023[160] Asset Management - The sale of the manufacturing facility to uBriGene was completed on July 28, 2023, for an upfront consideration of $6 million[115] - CFIUS requested the withdrawal and re-filing of the joint voluntary notice regarding the transaction with uBriGene, initiating a new 45-day review period on November 14, 2023[117] - The transaction was ultimately abandoned on May 13, 2024, following the execution of a National Security Agreement (NSA) due to CFIUS's concerns about national security risks[119] - The NSA obligates uBriGene to sell or dispose of certain equipment assets within 180 days, with potential expedited divestment options[120] - The company has the option to delay the payment of the deferred amount in the repurchase transaction if net assets fall below $20 million[122] - The company has terminated several license agreements, including those with St. Jude and the Mayo Clinic, which included forgiveness of outstanding amounts owed[163] Impairment and Other Charges - The company incurred impairment charges of $2.6 million in Q2 2024, with no impairment recorded in Q2 2023[152] - Other income for Q2 2024 was $0.31 million, compared to an expense of $2.34 million in Q2 2023, marking a $2.65 million improvement[154] - Impairment charges of $2.6 million were recorded for the six months ended June 30, 2024, related to leasehold improvements[159] Offerings and Agreements - The company issued warrants to purchase up to 367,800 shares at an exercise price of $0.5125 per share as part of its offerings[136] - The company entered into an At the Market Offering Agreement on May 31, 2024, allowing for the sale of common stock at its discretion[138] - The company terminated its 2018 At Market Issuance Sales Agreement effective June 5, 2024, which previously allowed for the issuance of up to $100 million in common stock[141]

As filed with the Securities and Exchange Commission on July 19, 2024. Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Mustang Bio, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 47-3828760 (I.R.S. Employer Identification Number) 377 Plantation ...

Core Insights - Mustang Bio's MB-106 therapy demonstrated a 90% overall response rate (ORR) in patients with Waldenstrom macroglobulinemia (WM), including three complete responses (CR) and six partial responses [1][10] - The therapy is being developed for relapsed or refractory B-cell non-Hodgkin lymphomas (B-NHLs) and chronic lymphocytic leukemia (CLL), with plans to expand into autoimmune indications [3][12] - Mustang Bio's stock has underperformed, losing 44.4% year to date compared to the industry's 7.1% decline [2] Efficacy and Safety - MB-106 showed a favorable safety and efficacy profile in a cohort of heavily pre-treated WM patients, all of whom were refractory to BTK inhibitors [5][12] - The therapy's results improved from a previous study where the ORR was 83% with two CRs [6][10] - If approved, MB-106 would be the first FDA-approved therapy for WM patients in the third-line setting [7] Market Context - Currently, there are no FDA-approved CAR T treatments for WM, indicating a significant unmet need that MB-106 could address [12] - The FDA granted orphan drug designation to MB-106 for the WM indication in 2022, highlighting its potential in the market [12] - Competing therapies in the WM space include Imbruvica and Brukinsa, both of which are BTK inhibitors [13][14]

Core Viewpoint - Mustang Bio (NASDAQ:MBIO) is experiencing a significant increase in stock trading volume, with over 13.9 million shares traded, far exceeding its average of 345,000 shares, amidst a delisting notice from Nasdaq [1][2]. Group 1: Stock Performance - MBIO stock has surged by 58.4% as of Wednesday morning, although it has declined by 76.5% year-to-date as of the previous market close [4]. - The company has a float of 9.36 million shares, indicating a relatively low number of shares available for trading [1]. Group 2: Delisting Notice - Mustang Bio received a delisting notice from Nasdaq due to its shares trading below the minimum bid price of $1 for an extended period [2][3]. - The company has until November 12, 2024, to regain compliance with Nasdaq's listing standards by maintaining a share price above $1 for 10 consecutive trading days [2][3]. - If compliance is not achieved, Mustang Bio may qualify for an additional 180-day extension to adjust its share price [4].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38191 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: | ...

As filed with the Securities and Exchange Commission on April 29, 2024. Registration Statement No. 333-275997 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Mustang Bio, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 2834 47-3828760 (Primary Standard Industrial Classification Code Number) Identification Number) 377 P ...

As filed with the Securities and Exchange Commission on April 29, 2024. Registration No. 333-278006 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MUSTANG BIO, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 2836 (Primary Standard Industrial Classification Code Number) 47-3828760 (I.R.S. Employer Identification Number ...