MBIO — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-05

• We expect to incur substantial expenses for the foreseeable future relating to research, development and commercialization of our potential products and may never achieve profitability. We do not have any products that are approved for commercial sale and, therefore, we do not expect to generate any…

• most recent fiscal years of audited financial statements in our Annual Reports on Form 10-K, have reduced disclosure obligations regarding executive compensation and certain other matters, and smaller reporting companies are permitted to delay adoption of certain recent accounting pronouncements dis…

• For the three months ended March 31, 2026 and 2025, research and development expenses were approximately $0.2 million and $(1.0) million, respectively. The increase of approximately $1.1 million is primarily attributed to $0.7 million of non-repeat savings recognized from the settlement of aged paya…

• For the three months ended March 31, 2026, and 2025, general and administrative expenses were $0.9 million and $1.2 million, respectively. The decrease of approximately $0.3 million is primarily attributed to a $0.2 million decrease in non-cash stock-based compensation expenses, primarily related to…

• For the three months ended March 31, 2026, and 2025, other income was $0.1 million and $0.1 million, respectively, all of which is related to interest income.

Text removed vs the prior filing · source: 10-Q · 2025-11-07

• We expect to incur substantial expenses for the foreseeable future relating to research, development and commercialization of our potential products. However, there can be no assurance that we will be successful in securing additional resources when needed, on terms acceptable to us, if at all. Ther…

• We are also developing a CAR T therapy for hematologic malignancies and autoimmune diseases in partnership with Fred Hutch targeting CD20 (MB-106) pursuant to a license agreement originally executed with Fred Hutch in 2017 (the “CD20 License”). In May 2021, we announced that the U.S. Food and Drug A…

• In September 2025, we received notice from Fred Hutch of its intent to terminate the CD20 License for cause in connection with unpaid patent expenses and maintenance fees. A 90-day cure period is applicable under the CD20 License. We intend to negotiate the terms of an arrangement with Fred Hutch pu…

• MB-106 (CD20-targeted CAR T cell therapy for Autoimmune Diseases)

• We are currently pursuing the development of MB-106, in collaboration with Fred Hutch, for autoimmune diseases. As described above, however, we are in ongoing discussions with Fred Hutch regarding potential termination of this program.

Text added vs the prior filing · source: 10-Q · 2026-05-05

• We are currently advancing our programs in solid tumors through clinical development. Developing and commercializing CAR T products is expensive, and we do not expect to generate meaningful product revenues in the foreseeable future until we obtain marketing approval for products in the United State…

• Since our inception, we have incurred substantial operating losses and expect to continue to incur significant operating losses for the foreseeable future, and we may never become profitable. To date, we have not generated positive cash flows from operations and have funded our operations primarily …

• We expect to continue generating operating losses and negative operating cash flows as we develop our product candidates, and we may need to raise substantial additional financing in the future to fund our operations and to support the continued development and potential commercialization of our pro…

• Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. The sale of additional equity o…

• In addition, in order to address our current or future funding constraints, we may be required to further revise our business plan and strategy, which may result in us (i) curtailing, delaying or discontinuing one or more of our research or development programs or the commercialization of any produc…

Text removed vs the prior filing · source: 10-Q · 2025-11-07

• We are currently advancing our programs in hematologic cancers, autoimmune diseases and solid tumors through clinical development. Developing and commercializing CAR T products is expensive, and we do not expect to generate meaningful product revenues in the foreseeable future until we obtain market…

• As of September 30, 2025, our cash and cash equivalents were $19.0 million. Based on our current business plan, there is substantial doubt regarding our ability to continue as a going concern for a period of one year after the date that our financial statements for the year ended September 30, 2025,…

• In addition, in order to address our current funding constraints, we may be required to further revise our business plan and strategy, which may result in us (i) further curtailing, delaying or discontinuing one or more of our research or development programs or the commercialization of any product …

• Our short operating history makes it difficult to evaluate our business and prospects.

• We have been conducting operations only since our incorporation in March 2015. Our operations to date have been limited. We have not yet demonstrated an ability to successfully complete clinical trials, obtain regulatory approvals, manufacture a clinical scale or