Clinical Development - The company is focused on developing CAR T therapies for hematologic malignancies and solid tumors, partnering with leading research institutions[115]. - As of September 30, 2024, 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[118][120]. - The overall complete response rate for follicular lymphoma in the Phase 1 trial was sustained at 100% (N=6), with no occurrences of severe CRS[124]. - The FDA accepted the IND application for the combination therapy MB-109, which includes MB-101 and MB-108, for treating IL13Rα2+ recurrent glioblastoma and high-grade astrocytoma[121][131]. - The FDA granted RMAT designation for MB-106, which may expedite the development and review process for the treatment of relapsed or refractory CD20 positive WM and FL[126]. - The Phase 1 investigator-sponsored trial for MB-106 in autoimmune diseases is planned to initiate in Q4 2024, with proof-of-concept anticipated in 2025[130]. - The company discontinued development of several CAR T therapy programs (MB-102, MB-103, MB-104, MB-105) following a portfolio review[122]. Financial Performance - The company has incurred substantial operating losses since inception and expects to continue incurring significant losses for the foreseeable future[134]. - The company reported stockholders' equity of $123,000 as of December 31, 2023, and a stockholders' deficit of approximately $8.7 million as of September 30, 2024[148]. - The company received a deficiency letter from Nasdaq on March 13, 2024, for not meeting the minimum stockholders' equity requirement of $2.5 million[148]. - The company submitted a Compliance Plan to Nasdaq on April 29, 2024, and was granted an extension of 180 days to regain compliance[149]. - The company completed a best efforts equity offering on May 2, 2024, raising approximately $3.2 million in net proceeds[156]. - The company entered into a Securities Purchase Agreement on June 19, 2024, for a registered direct offering, raising approximately $2.1 million in net proceeds[160]. - The company plans to use the proceeds from the June 2024 offering for general corporate purposes and working capital requirements[160]. - Research and development expenses for Q3 2024 were $57,000, a decrease of approximately $9.5 million compared to $9.5 million in Q3 2023, primarily due to reduced personnel costs and other R&D expenses[180]. - Total operating expenses for Q3 2024 were $1.457 million, down 86% from $10.307 million in Q3 2023[181]. - Net loss for Q3 2024 was $1.410 million, significantly improved from a net loss of $10.058 million in Q3 2023, representing an 86% reduction[181]. - For the nine months ended September 30, 2024, research and development expenses decreased by approximately $26.2 million to $8.2 million from $34.4 million in the same period of 2023, a reduction of 76%[189]. - General and administrative expenses for the nine months ended September 30, 2024, were $4.4 million, down from $7.5 million in 2023, representing a decrease of approximately $3.1 million or 42%[194]. - The company incurred impairment charges of $2.6 million for the nine months ended September 30, 2024, with no impairment recorded in the same period of 2023[191]. - Other income for the nine months ended September 30, 2024, was $0.4 million, compared to a loss of $2.5 million in 2023, reflecting an increase of approximately $2.9 million[196]. - Net loss for the nine months ended September 30, 2024, was $14.8 million, a decrease of $28.2 million or 66% from a net loss of $42.9 million in 2023[188]. - Cash and cash equivalents as of September 30, 2024, were $3.5 million, with expectations that current resources will fund operations through the first half of 2025[199]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $9.4 million, significantly lower than $42.2 million in the same period of 2023[203]. - The company completed equity offerings in May and June 2024, raising approximately $5.3 million for working capital and general corporate purposes[198]. - The company anticipates continued operating losses and has substantial doubt about its ability to continue as a going concern for the next 12 months[197]. Corporate Actions - The company announced a workforce reduction of approximately 81% in April 2024 to reduce costs and preserve capital, incurring restructuring charges of approximately $0.2 million[136]. - The sale of the manufacturing facility to uBriGene was completed on July 28, 2023, for an upfront consideration of $6 million[138]. - The company agreed to repurchase assets from uBriGene for a total purchase price of $1,395,138, with an upfront payment of $100,000 and a deferred amount of $1,295,138[145]. - The company executed a National Security Agreement on May 13, 2024, agreeing to abandon the transaction with uBriGene due to national security concerns[143]. - The company has been granted multiple extensions by CFIUS for the review of its transaction with uBriGene, with the latest investigation period ending on May 13, 2024[142]. - The company terminated its license agreements with St. Jude and the Mayo Clinic in April and June 2024, respectively, which included the forgiveness of outstanding amounts owed[199]. Stock and Warrant Activity - The company issued approximately 2.7 million shares of common stock at an average price of $0.44, generating gross proceeds of $1.2 million under the ATM Agreement during the nine months ended September 30, 2024[171]. - In October 2024, the company issued approximately 4.4 million shares of common stock at an average price of $0.34, resulting in gross proceeds of approximately $1.5 million[172]. - The company received approximately $4.0 million in gross proceeds from the exercise of Existing Warrants, which will be used for general corporate purposes and working capital[166]. - The exercise price for the New Series B-1 and B-2 Warrants is set at $0.27 per share, with the New Series B-1 Warrants expiring five years after stockholder approval[165]. - The company paid Wainwright a cash fee of 7.0% on the gross proceeds from the exercise of Existing Warrants, along with additional reimbursements totaling $75,000[167]. - The company recorded a gain of approximately $1.4 million on the sale of equipment in Q3 2023, with no such sales occurring in Q3 2024[183]. - The company is classified as a "smaller reporting company," with a market value of shares held by non-affiliates below $700 million and annual revenue under $100 million[176]. - Net cash used in financing activities was $30.0 million during the nine months ended September 30, 2023, primarily due to the repayment of the Term Loan[208]. - The company raised $0.2 million from the issuance of common shares in connection with the Employee Stock Purchase Plan (ESPP)[208]. - The company also generated $0.2 million of net proceeds from the Mustang ATM[208].
Mustang Bio(MBIO) - 2024 Q3 - Quarterly Report