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Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-101 (IL13Ra2-targeted CAR T-cells) to Treat Astrocytomas and Glioblastoma
Globenewswire· 2025-07-07 12:30
In an ongoing Phase 1 trial published in Nature Medicine, MB-101 was well-tolerated and 50% of patients achieved stable disease or better with two partial responses and two complete responses lasting 7.5 and 66+ months, respectively Preclinical data support a novel combination of MB-101 (IL13Rα2‐targeted CAR-T cell therapy) and MB-108 (HSV-1 oncolytic virus) to optimize clinical results FDA previously granted Orphan Drug Designation to Mustang for MB-108 for the treatment of malignant glioma WORCESTER, Mas ...
Mustang Bio(MBIO) - 2025 Q1 - Quarterly Report
2025-05-14 20:05
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, 2025 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 MUSTANG BIO, INC. (Exact name of registrant as specified in its charter) Delaware 47-3828760 (State or other jurisd ...
Mustang Bio(MBIO) - 2024 Q4 - Annual Report
2025-03-28 12:02
Financial Performance and Condition - The company incurred net losses of $51.6 million and $15.8 million for the years ended December 31, 2023, and 2024, respectively, with an accumulated deficit of $396.7 million as of December 31, 2024[157]. - As of December 31, 2024, the company's cash and cash equivalents were $6.8 million, raising substantial doubt about its ability to continue as a going concern for the next year[162]. - The company has not generated any revenue from its development stage products and does not expect to do so in the foreseeable future[156]. - The company anticipates significant fluctuations in its financial condition and operating results from quarter to quarter and year to year[169]. - The company will require substantial additional funding to advance its product candidates and may not be able to secure this funding on acceptable terms[171]. - The company has a limited operating history since its inception in March 2015, making it difficult to evaluate its business and prospects[167]. - The company reported a stockholders' deficit of $3.7 million as of December 31, 2024, indicating non-compliance with Nasdaq's minimum stockholders' equity requirement of $2.5 million[351]. - The company received a deficiency letter from Nasdaq on March 13, 2024, regarding non-compliance with the Equity Rule, with a plan submitted to regain compliance by April 29, 2024[351]. - The company was granted an extension until September 9, 2024, to demonstrate compliance with the Equity Rule but failed to do so[352]. - A hearing was requested on September 17, 2024, to address the potential delisting from Nasdaq due to continued non-compliance[353]. - The company was notified on May 16, 2024, of non-compliance with the Bid Price Rule, requiring a closing bid price of at least $1.00 per share for ten consecutive business days by November 12, 2024[354]. - The Panel granted an extension to demonstrate compliance with the Equity Rule through February 18, 2025, and the Bid Price Rule through January 31, 2025[355]. - The company completed a public offering on February 10, 2025, raising approximately $6.9 million, which helped in regaining compliance with the Equity Rule[356]. - The company is now subject to mandatory monitoring by the Panel for one year following the compliance notification on February 26, 2025[356]. - If the company fails to maintain compliance with Nasdaq's continued listing rules, it may face delisting, which could adversely affect stockholder liquidity and confidence[357]. - A delisting could also hinder the company's ability to obtain financing and may result in increased price volatility for its common stock[357]. Regulatory and Compliance Risks - The company faces risks related to the development and commercialization of CAR T products, which are expensive and may not generate meaningful revenues until marketing approval is obtained[161]. - The company is subject to SEC regulations limiting the amount of funds it can raise through public offerings, which may impact its ability to secure necessary capital[175]. - The company incurs significant increased costs due to compliance with the Sarbanes-Oxley Act, impacting legal and financial compliance costs[183]. - The company is classified as a "smaller reporting company," with reduced disclosure requirements until certain thresholds are met, including $250 million in non-affiliate common shares or $100 million in annual revenues[185]. - The company must navigate complex regulatory requirements and may need to amend clinical trial protocols, impacting costs and timelines[204]. - The regulatory approval process for product candidates is uncertain and expensive, often taking many years to complete[207]. - The FDA may delay, limit, or deny approval for various reasons, including disagreement with trial design or insufficient data demonstrating safety and efficacy[208]. - Approval procedures vary among foreign markets, which may involve additional testing and administrative reviews, potentially leading to significant delays[210]. - Regulatory approvals are limited to specific indications and conditions for which safety and efficacy have been demonstrated, affecting marketing capabilities[211]. - Off-label promotion is restricted, and non-compliance with FDA regulations could result in severe penalties, including product recalls[212]. - Manufacturing processes must comply with stringent regulations, and any failure could delay commercialization or lead to revenue loss[213]. - The FDA may require costly post-marketing studies or clinical trials to monitor product safety and efficacy after approval[223]. - Public concern regarding drug safety could lead to unfavorable labeling changes or additional regulatory scrutiny[228]. - Delays in patient enrollment for clinical trials could hinder the receipt of necessary regulatory approvals[229]. - The company must obtain FDA approval for any proposed product brand names, and delays in this process could adversely impact business[226]. - The company faces significant delays in clinical trial patient enrollment, which could increase development costs and limit financing opportunities[230]. - The company faces risks related to third-party manufacturers, including potential delays and compliance issues that could impact the development and commercialization of product candidates[260][265]. - The company is subject to regulatory compliance risks, including potential sanctions for non-compliance with cGMP regulations by third-party manufacturers[265]. - Compliance with healthcare laws and regulations may expose the company to significant civil, criminal, and administrative penalties, impacting future earnings[286]. - Relationships with healthcare providers and payors may be constrained by fraud and abuse laws, affecting marketing and distribution strategies[287]. Market and Competitive Risks - The company currently has no products for sale and is heavily dependent on the success of its product candidates, which are in early-stage clinical trials[190]. - The company has invested significant resources in the acquisition and development of product candidates but has not yet demonstrated the ability to commercialize them successfully[191]. - The development of CAR T technology is a focus area, but it presents significant challenges and uncertainties in commercialization[195]. - Delays in clinical trials could increase costs and hinder the ability to pursue regulatory approval for product candidates[199]. - The company anticipates facing increasing competition from generic versions of branded products, which could impact market acceptance and pricing[234]. - Market acceptance of product candidates is contingent on factors such as efficacy, safety, and third-party reimbursement, which are critical for generating revenue[235]. - The market for certain cancer treatments may be limited, affecting potential sales if the product candidates are only effective for specific cancer types[250]. - Negative public perception and regulatory scrutiny could hinder the commercialization of product candidates and affect business operations[251]. - The company must establish sales and marketing capabilities or partner with third parties to successfully commercialize approved product candidates[245]. - Obtaining adequate coverage and reimbursement from third-party payors is crucial for the commercial success of the company's product candidates[240]. - The company relies on third parties for conducting preclinical studies and clinical trials, which may affect control over these activities and lead to delays[253]. - The company may face challenges in establishing strategic collaborations, which could result in significant resource expenditure without guaranteed financial return[277]. - Competitors may develop alternative formulations that do not infringe on the company's patents, potentially harming the commercial opportunity for its product candidates[233]. Intellectual Property Risks - The company faces risks related to patent protection, which could impair its ability to commercialize technology and products if competitors develop similar offerings[293]. - The patent prosecution process is costly and time-consuming, and failure to secure necessary patents could adversely affect competitive positioning and revenue generation[296]. - The uncertain patent landscape in biotechnology and pharmaceuticals may hinder the company's ability to protect its innovations effectively[297]. - The company relies on a regulatory period of market exclusivity for its biologic product candidates, which is generally 12 years from marketing approval, but this period could be shortened by legislative changes[301]. - The company depends on licensors to maintain and enforce intellectual property rights, with limited control over their resources and strategies[302]. - If licensors fail to maintain patents, the company risks losing patent rights, which could significantly impact its business[303]. - The company may face costly litigation related to intellectual property claims, which could distract management and increase operating losses[309]. - The company in-licenses intellectual property from third parties, and disputes over these agreements could adversely affect product development and commercialization[315]. - The uncertainty surrounding patent litigation could compromise the company's competitive position in the marketplace[309]. - The company may not be able to ensure the protection of its trade secrets, which are difficult to safeguard and could harm its competitive position if disclosed[312]. - The company may face claims regarding the wrongful use of trade secrets by employees or consultants, leading to potential litigation costs[311]. - The scope and validity of the company's patent rights are highly uncertain, with risks of patents being invalidated or interpreted narrowly[307]. Operational and Strategic Risks - The company may need to revise its business plan and strategy due to current funding constraints, potentially leading to delays or discontinuation of research and development programs[166]. - The company is increasingly dependent on information technology systems, which face risks from cyber-attacks and system failures that could disrupt operations[323]. - Health pandemics or epidemics, such as COVID-19, could disrupt operations, delay research and development, and negatively impact productivity[331]. - Economic and geopolitical conditions, including trade policies and conflicts, could materially affect the company's operations and financial condition[332][333]. - Attracting and retaining key personnel is critical, as competition for qualified management and scientific personnel is intense[334]. - Misconduct by employees or third-party partners could lead to regulatory noncompliance and significant reputational harm[335][337]. - Unauthorized disclosures of proprietary information could result in monetary damages and harm strategic initiatives[338]. - Legislative changes, such as the ACA and the IRA, could increase costs and limit pricing flexibility, adversely affecting profitability and growth prospects[278][280]. - Future healthcare reforms could limit government payments for healthcare products, resulting in reduced demand and pricing pressures for the company's products[282]. - Future healthcare reforms may impose stricter coverage criteria and downward pressure on product pricing, potentially affecting revenue generation and profitability[283]. - Changes in FDA funding could hinder the agency's ability to hire key personnel, impacting the timely development and commercialization of new products[284]. - Disruptions at the FDA, including government shutdowns, may delay the review and approval of new drugs, adversely affecting business operations[285].
Mustang Bio Regains Compliance with Nasdaq Capital Market Requirement
Globenewswire· 2025-03-05 21:15
Group 1 - Mustang Bio, Inc. has regained compliance with Nasdaq's minimum stockholders' equity requirement as per Nasdaq Listing Rule 5550(b)(1) [1][2] - The company previously satisfied the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing, thus meeting all Nasdaq Capital Market listing requirements [2] - Mustang Bio is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers, aiming to license or acquire technologies to fund research and development [3] Group 2 - Mustang Bio has partnered with leading medical institutions to advance CAR-T therapies [3] - The company's common stock is registered under the Securities Exchange Act of 1934 and it files periodic reports with the SEC [3]
Mustang Bio Announces Sale of Fixed Assets and Exit of Facility
Globenewswire· 2025-02-27 21:05
Core Viewpoint - Mustang Bio, Inc. has exited its lease for a manufacturing facility in Worcester, Massachusetts, and divested certain fixed assets to AbbVie for $1.0 million, while relocating its corporate headquarters to Waltham, Massachusetts [1][2]. Group 1: Financial Implications - The termination of the lease is expected to result in approximately $2.0 million in cash expense savings over the next 24 months [2]. - The divestment of fixed assets to AbbVie Bioresearch Center Inc. was completed for a total of $1.0 million [1]. Group 2: Strategic Focus - The company remains committed to advancing its existing portfolio and plans to initiate a novel clinical trial with MB-109, targeting recurrent glioblastoma and high-grade astrocytomas in the second half of 2025 [3]. - MB-109 is a combination therapy that includes MB-101 (IL13Rα2-targeted CAR-T cell therapy) and MB-108 (HSV-1 oncolytic virus), aimed at enhancing the efficacy of CAR-T cell therapy by modifying the tumor microenvironment [4]. Group 3: Company Overview - Mustang Bio is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers, partnering with leading medical institutions to advance CAR-T therapies [5].
Mustang Bio Regains Compliance with Nasdaq Minimum Bid Price Requirement
Globenewswire· 2025-02-11 21:10
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]
Mustang Bio(MBIO) - 2024 Q3 - Quarterly Report
2024-11-08 21:01
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 Granted Orphan Drug Designation by U.S. FDA for MB-108 (HSV-1 oncolytic virus) to Treat Malignant Glioma
GlobeNewswire News Room· 2024-11-07 13:30
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]
Mustang Bio Announces Exercise of Warrants for $4 Million Gross Proceeds
GlobeNewswire News Room· 2024-10-24 18:10
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].
Mustang Bio(MBIO) - 2024 Q2 - Quarterly Report
2024-08-13 20:01
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]