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]
Mustang Bio(MBIO) - 2024 Q2 - Quarterly Report