MBRX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• • Our ability to obtain additional funding to commence or continue our clinical trials, fund operations and develop our product candidates;

• • The success or the lack thereof, including the ability to recruit subjects and onboard new clinical trial sites on a timely basis, for a variety of reasons, of our clinical trials through all phases of clinical development;

• • Exhibited positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the Company's pivotal Phase 2/3 MIRACLE trial, analyzed on a full intent-to-treat basis with no patient exclusions with both Annamycin treatment arms demonstrating favorable efficacy trends c…

• Blinded data update (n=62): On July 31, 2026, we announced updated preliminary blinded results from Part A of our MIRACLE trial. With 62 subjects evaluable to date in Part A, the preliminary blinded CR rate was 24% and the CRc rate was 37%. Of those 62 subjects, 30, or 48%, had previously received a…

• Across three successive blinded analyses, at 30, 45 and 62 evaluable subjects, the blinded CRc has remained within a narrow band of approximately 37% to 40%, while the proportion of subjects entering the trial after failure of a first-line venetoclax-based regimen has risen from 31.1% in the n=45 po…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• • The success or the lack thereof, including the ability to recruit subjects and onboard new clinical trial sites on a timely basis, for a variety of reasons, of our clinical trials through all phases of clinical development;

• Our ability to obtain additional funding to commence or continue our clinical trials, fund operations and develop our product candidates;

• • Shown promising blinded safety and efficacy data for the first 30 subjects treated in the MIRACLE trial as we head towards the planned interim unblinding of data for the first 45 subjects treated in Part A of the MIRACLE trial in mid-2026;

• On May 13, 2026, we announced that the first unblinding of data from our pivotal Phase 2B/3 “MIRACLE” trial remains on track to occur prior to June 30, 2026, as expected. The MIRACLE trial is evaluating Annamycin in combination with cytarabine compared to cytarabine plus a placebo for the treatment …

• We also reported that preliminary blinded efficacy data for the first 45 subjects treated continue to approximate previously disclosed results, including a composite complete remission rate (CRc) exceeding 40% and a complete remission (CR) rate of approximately 30%. These results compare favorably t…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• We are not currently in compliance with Nasdaq’s continued listing requirements related to the bid price of our common stock and if we are unable to regain compliance with the listing requirements, our common stock will be delisted from Nasdaq which could have a material adverse effect on our financ…

• Since July 31, 2026, the closing price of our common stock has been below $1.00, and if our common stock remains below $1.00 for 30 consecutive business days we will not be in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). In accordance with Nasdaq rules, we would normally be…

• Delisting from Nasdaq would adversely affect our ability to raise additional financing through the public or private sale of equity securities, may significantly affect the ability of investors to trade our securities and may negatively affect the value and liquidity of our common stock. Delisting a…

• We will require additional financing in the near term, which financing may result in the reduction of the exercise price of the Series I warrants that we issued in our August 2026 Offering.

• Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. We will require substantial additional future capital in order to complete clinical development and commercialize Annamycin. The Series I warrants that we issued in the August 2026 Offerin…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• We are subject to Nasdaq's continued listing requirements. We have in the recent past failed to satisfy one or more of the requirements, and if we fail to satisfy one or more of the requirements in the future, we may be delisted from Nasdaq.

• During 2025, we received notices that we were not in compliance with Nasdaq Listing Rule 5550(b)(1) (the “Equity Rule”), which requires that we maintain a minimum of $2.5 million in stockholders’ equity, and Nasdaq Listing Rule 5550(a)(2), which related to the bid price for our common stock being be…

• On December 15, 2025, we received a letter from Nasdaq confirming that we had regained compliance with the Bid Price Rule because the closing bid price of the Company’s common stock was $1.00 per share or greater for the 10 consecutive business days from December 1, 2025, through December 12, 2025. …

• Although we are currently in compliance with all Nasdaq continued listing standards, there is no assurance that we will be able to maintain such compliance in the future. Delisting from Nasdaq would adversely affect our ability to raise additional financing through the public or private sale of equi…

• We will require additional financing in the near term, which financing may result in the reduction of the exercise price of certain of our warrants.

Text added vs the prior filing · source: 10-Q · 2026-08-13

• On August 10, 2026, Joy Yan resigned as a member of the Company's Board of Directors. Dr. Yan's resignation from the Board was not a result of any disagreement with the Company on any matter relating to the Company's operations, policies or practices.

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• On May 6, 2026, we agreed to issue warrants to purchase 100,000 shares of common stock with an exercise price of $2.48 per share to an entity providing consulting services, which warrants will vest in 12 equal monthly installments over one year, subject to the entity's continued provision of consult…