Moleculin Biotech, Inc. 8-K Filings

Moleculin Biotech, Inc. (MBRX) is using an attached presentation for its corporate presentation posted on the company website. The company states that the presentation is furnished, not filed under the Exchange Act, and will not be incorporated by reference into other filings unless specifically identified as incorporated.

Moleculin Biotech, Inc. (MBRX) stockholders approved an increase of 3,861,894 shares in the 2024 Stock Plan, bringing the number of shares authorized for issuance under the plan to 3,875,999, including the increase. Walter V. Klemp, Robert E. George, Michael D. Cannon, John Climaco and Elizabeth A. Cermak were elected as directors. Stockholders also ratified Grant Thornton LLP as the independent registered public accounting firm for the year ending December 31, 2026, and approved a non-binding advisory resolution on executive compensation.

Stockholders approved board authority to effect a reverse stock split at a ratio from 1-for-2 to 1-for-20, as determined by the board in its sole discretion prior to the one-year anniversary of the Annual Meeting. The proposed amendment to eliminate supermajority voting requirements was not approved; the amendment required affirmative votes from two-thirds of outstanding common shares. As of August 19, 2026, 19,477,380 common shares were outstanding and entitled to vote, and 8,247,089 shares were present or represented, constituting a quorum.

Moleculin Biotech, Inc. is using an attached presentation for its corporate presentation posted on its website. The presentation is furnished, not filed under the Exchange Act, and is not incorporated by reference into other filings unless specifically identified as incorporated.

Moleculin Biotech, Inc. (MBRX) closed enrollment in Part A of its pivotal Phase 2/3 MIRACLE trial of Annamycin plus cytarabine for adults with relapsed or refractory acute myeloid leukemia, with 89 subjects enrolled. The company says it remains on track for a comprehensive Part A data readout in the first quarter of 2027.

Part A is randomized and double-blind, comparing two Annamycin doses plus cytarabine with cytarabine plus placebo; outcomes for all arms are measured after one cycle. The planned analysis is expected to assess efficacy and safety across the randomized population and support selection of a dose for Part B. Moleculin said blinded data continue to show a lack of cardiotoxicity. It also disclosed that trial milestones assume timely access to significant additional financing, for which it has no commitments.

Moleculin Biotech, Inc. (MBRX) announced publication of a peer-reviewed pooled analysis of Annamycin’s cardiac safety across five clinical trials. The analysis covered 90 patients with acute myeloid leukemia or metastatic soft tissue sarcoma; paired echocardiographic data were available for 78 patients. Moleculin said an independent evaluation by a Cleveland Clinic cardio-oncology laboratory found no clinical or subclinical evidence of treatment-related cardiotoxicity, including at cumulative Annamycin exposures exceeding traditional lifetime limits for conventional anthracyclines.

The authors concluded that the findings support continued clinical evaluation. Annamycin is being evaluated in Moleculin’s MIRACLE program for relapsed or refractory AML. Moleculin said it requires significant additional financing, for which it has no commitments, to conduct the described clinical trials. The company also said the dataset is subject to review of data from future subjects in current and future trials and long-term follow-up with subjects in current trials.

Moleculin Biotech, Inc. (MBRX) announced preclinical data indicating that its lead drug candidate Annamycin (naxtarubicin) has antitumor activity in pancreatic cancer that is partially mediated by CD8+ T-cell cytotoxicity. The findings are being presented at the AACR Conference on Pancreatic Cancer in San Diego, September 25–28, 2026. The results suggest a possible immune-mediated mechanism alongside Annamycin’s direct cytotoxic activity.

The findings come from preclinical models, may not predict results in humans, and Annamycin is not currently in clinical development for pancreatic cancer. Moleculin said its lead clinical program remains the MIRACLE trial evaluating AnnAraC for relapsed or refractory acute myeloid leukemia; the pancreatic cancer findings are separate from that trial. The company stated that it will require significant additional financing, for which it has no commitments, to conduct the clinical trials described, and that its milestones assume timely financing.

Moleculin Biotech, Inc. (MBRX) announced that the Mexican Patent Office granted Patent No. 436849 for its lung-targeted liposomal Annamycin technology; the patent remains in force until November 23, 2040.

To date in September 2026, Moleculin issued 888,400 common shares through its at-the-market offering for $0.48 million in aggregate gross proceeds. Following completion of those issuances, the company will have 20,385,780 shares outstanding. The Series I Warrants’ exercise price was reduced from $0.75 to $0.51 per share after the ATM share issuances; the warrants cover up to 37,130,001 shares. Moleculin said it will require significant additional financing, for which it has no commitments, to conduct the clinical trials described.

Moleculin Biotech, Inc. (MBRX) reports that on September 15, 2026 it received a Nasdaq staff determination letter stating that the company is not in compliance with the $1.00 minimum bid price requirement, because its common stock’s closing bid price was below $1.00 for 30 consecutive business days from July 31, 2026 through September 11, 2026. Due to a prior 1-for-25 reverse stock split effected on December 1, 2025, Nasdaq Listing Rule 5810(c)(3)(A)(iv) makes the company ineligible for the usual 180‑day compliance period. Moleculin plans to request a hearing before the Nasdaq Hearings Panel; a timely request will stay any suspension or delisting, and the stock will continue trading on The Nasdaq Capital Market during the hearing process, though there is no assurance continued listing will be granted.

Moleculin Biotech, Inc. (MBRX) reported that new preclinical and translational data on its lead drug candidate Annamycin (naxtarubicin) will be presented at three scientific venues in September 2026, including the AACR Conference on Pancreatic Cancer: New Frontiers in Biology and Therapeutic Development.

The presentations examine how Annamycin’s lipophilic structure drives tissue-specific concentration, its activity as a topoisomerase II–targeting anthracycline, and preclinical antitumor effects in pancreatic cancer that may involve CD8+ T cell cytotoxicity. These data are intended to inform development of Annamycin alongside the ongoing MIRACLE pivotal Phase 2/3 trial in relapsed or refractory acute myeloid leukemia.

Moleculin Biotech, Inc. (MBRX) reported that on August 31, 2026 it is using a corporate presentation for its investor communications, which is included as Exhibit 99.1. The presentation is furnished under a disclosure item for informational purposes and is not deemed filed or incorporated into other securities law filings unless specifically stated.

Moleculin Biotech reported second quarter 2026 results and updated progress on its pivotal Phase 2/3 MIRACLE trial of Annamycin in relapsed or refractory acute myeloid leukemia. Preliminary unblinded data from the first 45 patients in Part A showed complete remission rates at least three times greater than the control arm, with no evidence of cardiotoxicity reported to date. Enrollment is on track to reach 90 patients in September 2026, with an unblinded efficacy readout expected in the December 2026 to February 2027 timeframe and Part B initiation planned for the first half of 2027.

Research and development expenses for the quarter were $5.5 million, up from $3.6 million a year earlier, mainly driven by the MIRACLE trial. General and administrative expenses were approximately $2.1 million, flat year over year. The company reported a quarterly net loss of $7.6 million, or $1.40 per share. Cash and cash equivalents were $7.3 million as of June 30, 2026, and together with $9.3 million raised after quarter-end, management expects this to fund planned operations into the first quarter of 2027, while also noting that significant additional financing will be required to conduct clinical trials as described.

Moleculin Biotech entered placement agency and securities purchase agreements for a public offering of 12,376,667 shares of common stock or pre-funded warrants and Series I common stock purchase warrants to buy up to 37,130,001 shares. The combined public offering price is $0.75 per share (or pre-funded warrant) and accompanying warrant, generating approximately $9.3 million in gross proceeds before fees and expenses. The sale closed on August 3, 2026 under an effective Form S-1 registration statement.

The pre-funded warrants are exercisable at $0.001 per share until fully exercised, while the common warrants are exercisable at $0.75 per share for five years after the initial exercise date, subject to 4.99%–9.99% beneficial ownership limits and an exercise price adjustment feature with a $0.21 floor. Net proceeds are intended to advance the Annamycin program through clinical development and for working capital. The company agreed to restrictions on additional equity issuances and variable rate transactions, 60‑day lock-ups for directors and officers, a 6.5% cash fee plus up to $100,000 of expenses to the placement agent, and a 1.0% fee to a financial advisor.

Moleculin Biotech is reporting updated preliminary blinded results from Part A of its pivotal Phase 2/3 MIRACLE trial of Annamycin plus cytarabine (AnnAraC) in relapsed or refractory acute myeloid leukemia. With 62 subjects evaluable, the blinded complete remission (CR) rate is 24% and the composite complete remission (CRc) rate is 37%.

Of these 62 subjects, 30 (48%) had previously received a venetoclax-based regimen; in this subgroup, blinded CR and CRc rates are 23% and 37%, similar to the overall evaluable population. The analysis remains blinded and includes control-arm patients, and is therefore expected to be below unblinded Annamycin-arm results reported in June, when CRc reached 50% and 57% in the two Annamycin arms versus 29% for control after a single cycle. Enrollment stands at 74 of 90 Part A subjects, with the Company expecting to treat the 90th subject in September 2026 and to unblind comprehensive Part A data in the December 2026 to February 2027 timeframe. Across the trial, the Company reports no evidence of cardiotoxicity, and notes that Annamycin holds Fast Track Status and Orphan Drug Designations for relapsed or refractory AML.

Moleculin Biotech reported positive preliminary results from the first 45 patients in Part A of its pivotal Phase 2/3 MIRACLE trial in relapsed or refractory acute myeloid leukemia. On a full intent-to-treat basis, both Annamycin arms showed higher remission rates after a single treatment cycle compared with the HiDAC control arm.

The 190 mg/m² and 230 mg/m² Annamycin plus HiDAC arms achieved complete remission rates of 43% and 36%, versus 12% for control. Composite complete remission reached 50% and 57% in the Annamycin arms versus 29% for control. An independent data monitoring committee saw a strong numeric efficacy trend favoring Annamycin and recommended continuing the trial without dropping either dose.

Enrollment in Part A has reached 67 of 90 planned subjects, and efficacy data from Part A are expected to carry into the pivotal Part B analysis. The company notes that these efficacy results are interim, based on a small sample size and not yet statistically significant, and it will need significant additional financing, with no current commitments, to complete its clinical plans.

Moleculin Biotech, Inc. reported that, after filing its quarterly report for the period ended March 31, 2026, investors exercised warrants to purchase 1,361,500 shares of common stock, generating gross proceeds of approximately $2.7 million for the company. As of June 29, 2026, Moleculin Biotech had 7,065,000 shares of common stock outstanding. The company also made available an updated corporate presentation, furnished as Exhibit 99.1.

Moleculin Biotech furnished an update on independent market research evaluating its lead drug candidate Annamycin for relapsed/refractory acute myeloid leukemia. Surveyed oncologists reported an average likelihood-to-prescribe score of 6 out of 7, citing deep remissions, transplant-bridging potential, biomarker-agnostic use and reduced cardiotoxicity.

Interviews with hospital administrators and insurers indicated that payers view Annamycin as addressing a significant unmet need, with a potentially meaningful value proposition. Moleculin highlighted that it is a Phase 3 clinical stage company and is advancing the MIRACLE pivotal Phase 2b/3 trial of AnnAraC in R/R AML, while emphasizing that the research sample was small and qualitative and that it will require significant additional financing to conduct its clinical trials.

Moleculin Biotech filed an 8-K to highlight new clinical data on its lead drug candidate Annamycin presented at the 2026 ASCO meeting. A pooled analysis of 90 patients with acute myeloid leukemia and soft tissue sarcoma found no detectable cardiotoxicity, even at cumulative doses far above traditional anthracycline limits.

The analysis used paired left ventricular ejection fraction assessments in 78 patients and was independently reviewed by Cleveland Clinic cardiology specialists. Moleculin views these safety data as strengthening support for its pivotal Phase 2b/3 MIRACLE trial of AnnAraC (Annamycin plus cytarabine) in relapsed or refractory AML, with unblinding of the first 45 patients expected in June 2026.

Moleculin Biotech, Inc. furnished a new investor presentation as part of a current report. The company is using this May 2026 corporate presentation, attached as Exhibit 99.1, for its website and investor communications. The material is provided under a Regulation FD disclosure item and is expressly treated as “furnished,” not “filed,” which means it is not automatically incorporated into other Securities Act or Exchange Act filings unless specifically referenced later.

Moleculin Biotech, Inc. furnished a press release announcing that pooled cardiac safety data for its lead drug candidate Annamycin were accepted for poster presentation at the 2026 ASCO Annual Meeting. The pooled analysis covered 90 patients with acute myeloid leukemia and soft tissue sarcoma treated across five completed clinical trials.

The abstract reports a median cumulative L-Annamycin dose of 660 mg/m2, with most patients receiving doses above conventional lifetime anthracycline limits, yet showing no statistically significant change in left ventricular ejection fraction from baseline to final assessment and no evidence of drug-induced cardiotoxicity on independent review. Previously reported Phase 1b/2 data in relapsed or refractory AML showed a 50% complete remission rate, 60% composite complete remission rate, and median overall survival of 12.39 months, supporting the company’s ongoing pivotal Phase 2b/3 MIRACLE trial of Annamycin plus cytarabine.

Moleculin Biotech reported first quarter 2026 results and highlighted progress in its pivotal MIRACLE trial for relapsed or refractory acute myeloid leukemia. Early blinded data show a 40% composite complete remission rate in this difficult-to-treat population. The first interim unblinding is expected in June 2026 after enrollment of 45 subjects, with the 90th subject targeted for Q3 2026.

For the quarter ended March 31, 2026, Moleculin had no revenue and reported research and development expenses of $5.4 million, up from $3.4 million a year earlier, mainly due to MIRACLE trial costs. General and administrative expenses were stable at about $2.5 million. The company recorded a net loss of $12.8 million versus $5.9 million in 2025, influenced by warrant-related fair value charges and a warrant deemed dividend, bringing net loss available to common stockholders to $14.6 million, or $3.54 per share.

Cash and cash equivalents were $10.3 million as of March 31, 2026. Management believes existing cash, together with recent financing proceeds, will fund planned operations into the third quarter of 2026, and notes that significant additional financing will be required to conduct the described clinical trials.

Moleculin Biotech reported encouraging preliminary blinded results from its pivotal Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in relapsed or refractory acute myeloid leukemia. Among the first 45 subjects, the complete remission rate approximates 30%, with a composite complete remission rate exceeding 40%.

The company notes these blinded response rates compare favorably to historical cytarabine monotherapy complete remission rates of about 17–18% in similar second-line AML populations. As of May 1, 56 of the planned 90 Part A subjects had been recruited, and the first 45-subject unblinding is expected before June 30, 2026.

Moleculin Biotech, Inc. furnished an update on its lead drug Annamycin, highlighting new cardiac safety data in relapsed/refractory acute myeloid leukemia (R/R AML). An abstract accepted for the European Hematology Association 2026 Congress reports an independent Cleveland Clinic review of pooled results from five completed trials.

The analysis covered 90 Annamycin-treated subjects and found no clinically significant treatment-related cardiotoxicity even at cumulative anthracycline-equivalent doses beyond conventional lifetime limits. Among 78 patients with verified pre- and post-treatment ejection fraction measurements, none met criteria for clinically significant left ventricular dysfunction and mean ejection fraction remained stable, with no link between cumulative dose and cardiac decline. Management believes this supports Annamycin’s potential as a differentiated anthracycline for heavily pretreated R/R AML patients, while noting that further data, long-term follow-up, and significant additional financing will be needed to advance clinical trials.

Moleculin Biotech, Inc. filed a current report to highlight a new Hong Kong patent covering its proprietary method of reconstituting liposomal Annamycin, its lead oncology candidate. The patent, titled “Method of Reconstituting Liposomal Annamycin” (No. 40073244), extends protection through June 25, 2040 and is jointly owned with The University of Texas System.

The company views this as an additional layer of global intellectual property protection for Annamycin ahead of an expected Phase 3 clinical data release later this quarter. Moleculin notes broader Annamycin patent coverage across regions including the United States, Europe and multiple Asian markets, supporting its long-term commercialization strategy in relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases.

Moleculin Biotech, Inc. reported new preclinical data showing its lead drug candidate Annamycin extended median survival by more than 60% in a metastatic pancreatic cancer model, from 18 to 29 days. Liposomal Annamycin produced significant tumor growth inhibition across multiple pancreatic ductal adenocarcinoma models with strong statistical significance (p<0.001).

The drug showed much higher accumulation in pancreatic tissue and tumors than doxorubicin (p<0.0001), suggesting a mechanistic basis for its activity, and induced increased CD8+ and CD4+ T-cell infiltration, indicating potential to turn “cold” tumors more immune-responsive. Annamycin continued to demonstrate absence of cardiotoxicity and is also being evaluated in the pivotal Phase 2B/3 MIRACLE trial in relapsed or refractory acute myeloid leukemia.

Moleculin Biotech, Inc. reported results of a Special Meeting of Stockholders. As of the February 20, 2026 record date, there were 4,933,110 shares of common stock outstanding, with 2,382,989 shares represented at the meeting, constituting a quorum.

Stockholders approved a Nasdaq-related proposal authorizing the issuance of up to 6,367,956 shares of common stock upon exercise of certain warrants issued on February 20, 2026. The vote was 854,036 for, 211,394 against, and 7,489 abstentions, with 1,310,070 broker non-votes.

Stockholders did not approve an amendment to change the company’s name to Moleculin Inc., as this proposal required a majority of all outstanding shares to vote in favor. An adjournment proposal to allow additional proxy solicitation, if needed, was approved.

Moleculin Biotech announced enrollment of the 45th subject in its pivotal Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine (AnnAraC) for adults with relapsed or refractory acute myeloid leukemia. This completes the threshold for an interim data unblinding targeted for mid-2026.

The interim analysis is expected to include about 30 AnnAraC-treated patients and 15 control patients on cytarabine plus placebo, providing early insight into efficacy, safety, and dose selection as the study advances toward its Phase 3 portion and a potential accelerated approval pathway based on complete remission.

Moleculin Biotech, Inc. furnished a new corporate presentation as Exhibit 99.1. The company states this presentation is being used for its corporate presentation and is also posted on its website. The material is provided under Item 7.01 and is furnished, not filed, under the Exchange Act.

Moleculin Biotech reported a 2025 net loss of $33.6M, with research and development expenses of $15.9M and general and administrative plus depreciation and amortization expenses of $9.2M. Cash and cash equivalents were $8.9M as of December 31, 2025, and management expects existing cash plus $8.3M of first‑quarter 2026 financing proceeds to fund operations into the third quarter of 2026.

The company highlighted rapid progress in its pivotal global MIRACLE trial of Annamycin plus cytarabine (AnnAraC) for relapsed or refractory AML. Blinded preliminary data from the first 30 subjects showed a composite complete remission rate of 40%, including 30% complete remission and 10% CRh, across six countries, despite roughly 35% of subjects having prior venetoclax exposure and other high‑risk features. An initial 45‑patient interim unblinding is planned for mid‑2026 as part of the adaptive Phase 2B/3 design.

Moleculin Biotech entered into warrant exercise inducement agreements with holders of existing warrants to buy up to 2,122,652 shares at $3.90 per share. The company expects aggregate gross proceeds of up to approximately $8.3 million from these exercises before fees.

In return, Moleculin will issue new Series H Inducement Warrants to purchase up to 6,367,956 shares, equal to 300% of the exercised shares. These warrants will have a five-year term and an exercise price per share equal to the lesser of $3.90 and the lowest volume-weighted average price over the five trading days after the public announcement, subject to shareholder approval. The warrants include price-adjustment features with a floor of $0.962, beneficial ownership limits of 4.99% or 9.99%, and cashless exercise under certain conditions.

Moleculin Biotech, Inc. filed a current report to make investors aware that it is using an updated corporate presentation. The company states that this presentation is posted on its website and is included as Exhibit 99.1.

The company clarifies that the information in this presentation is being furnished under a disclosure item and is not considered "filed" under securities laws, unless a future document specifically incorporates it by reference. This distinction affects how the information is treated for legal and liability purposes.

Moleculin Biotech updated progress on its pivotal Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in second-line relapsed/refractory AML. As of February 10, 2026, 35 subjects have been treated, with another 11 in screening or identified, targeting 45 subjects for the first data unblinding.

In the first 30 treated subjects with blinded efficacy data, the company reports a preliminary composite complete remission (CRc) rate of 40%, made up of 30% complete remission (CR) and 10% CR with partial hematologic recovery (CRh). Moleculin highlights that roughly 35% of treated subjects had failed prior venetoclax regimens and that current blinded CR rates are described as 67% higher than historical cytarabine-alone HiDAC trials at about 17–18% CR.

The company continues to report an absence of cardiotoxicity for Annamycin based on safety data from 90 prior trial subjects and expects to reach 45 treated MIRACLE subjects in the first quarter of 2026, with unblinding of the first 45 subjects’ efficacy data anticipated in late second quarter 2026, followed by additional unblindings as Part A of the trial completes.

Moleculin Biotech reported that the Japan Patent Office issued a notice of allowance for Patent Application No. 2021-577862, titled “METHOD OF RECONSTITUTING LIPOSOMAL ANNAMYCIN.” A patent from this application is expected to be granted in Japan in the coming months.

The allowed claims cover proprietary methods for reconstituting and preparing liposomal Annamycin from a preliposomal lyophilizate under controlled temperature conditions, targeting precise concentrations for intravenous use and consistent dosing and stability. This Japanese protection complements existing U.S. and European patent coverage for Annamycin.

Annamycin, also known as naxtarubicin, is Moleculin’s lead anthracycline drug candidate in Phase 3 development for relapsed or refractory acute myeloid leukemia, with Fast Track Status and multiple Orphan Drug Designations in the U.S. and Europe.

Moleculin Biotech, Inc. stockholders approved the issuance of up to 2,610,823 shares of common stock upon exercise of certain warrants issued on December 11, 2025. The warrant-related Nasdaq Proposal passed with 578,385 votes for, 68,176 against and 3,444 abstentions, with 546,307 broker non-votes.

Stockholders did not approve changing the company’s name to Moleculin Inc., because the vote did not reach the required majority of all outstanding shares, even though 1,124,921 voted for, 67,441 against and 3,950 abstained. They also approved a potential adjournment to solicit additional proxies if needed.

Moleculin Biotech, Inc. filed a current report to note that it is using a new corporate presentation for investors and other audiences. The presentation is posted on the company’s website and is included as Exhibit 99.1 to the report. The company specifies that this material is being furnished under a disclosure item for informational purposes and is not deemed filed under securities laws unless later specifically incorporated by reference.

Moleculin Biotech, Inc. filed a current report to furnish a press release about new safety information for its investigational drug Annamycin. The company states that an independent assessment confirmed no cardiotoxicity of Annamycin in 90 subjects, addressing an important safety consideration related to potential effects on the heart. The press release is included as Exhibit 99.1 and is furnished under Item 7.01, meaning it is provided for information purposes and is not treated as filed under securities law requirements.

Moleculin Biotech, Inc. filed a current report to furnish a press release dated January 12, 2026. The release states that the company is accelerating its outlook into 2026, with its first pivotal trial unblinding described as on track.

The press release also highlights global trial expansion and multiple clinical programs that are externally and investigator-initiated trial (IIT) funded. The information is furnished under a Regulation FD disclosure item and is not deemed filed under the federal securities laws unless later specifically incorporated by reference.

Moleculin Biotech, Inc. reported that it has regained compliance with Nasdaq’s continued listing standards. The company had previously been notified in May 2025 that it failed to meet Nasdaq Listing Rule 5550(b)(1), which requires at least $2.5 million in stockholders’ equity, and that it also did not meet the alternative tests for market value of listed securities or net income from continuing operations. In November 2025, Nasdaq staff issued a delisting determination, which Moleculin appealed to a hearing panel. On January 6, 2026, Nasdaq staff informed the panel that Moleculin is now in compliance with Listing Rule 5550(b)(1) and all other applicable continued listing standards, so the previously scheduled hearing has been cancelled and the company’s Nasdaq listing remains in place.

Moleculin Biotech, Inc. reports that it has issued a press release announcing positive results from a physician-sponsored Phase 1 clinical trial conducted at Emory University. The trial took place at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta and was led by pediatric oncologist Tobey MacDonald, MD, who identified STAT3 as critical to certain childhood brain tumors and directs the Pediatric Neuro-Oncology Program.

The company has attached the press release as Exhibit 99.1 to this report and incorporated it by reference, while specifying that the information is being furnished under the securities laws rather than filed.

Moleculin Biotech, Inc. reports that it has regained compliance with Nasdaq’s minimum bid price requirement for continued listing of its common stock. The company had previously been notified on June 27, 2025 that its shares failed to meet the Nasdaq Listing Rule 5550(a)(2) requirement after trading below $1.00 per share for 30 consecutive business days.

Nasdaq’s Listing Qualifications Staff informed Moleculin on December 15, 2025 that the company is back in compliance because the closing bid price of its common stock was at or above $1.00 per share for 10 consecutive business days from December 1, 2025 through December 12, 2025. Nasdaq indicated that the company is now in compliance with the bid price rule and that the matter is closed.

Moleculin Biotech, Inc. (MBRX) furnished a new corporate presentation as an exhibit to a current report. The presentation, identified as Exhibit 99.1, is being used for the company’s corporate communications and is posted on its website. The company states that this material is being furnished under Regulation FD and will not be treated as "filed" for purposes of the Securities Exchange Act of 1934 or automatically incorporated into other SEC filings unless specifically referenced. This is primarily a disclosure and investor‑information update rather than an operational or financial event.

Moleculin Biotech, Inc. reported that Nasdaq has issued a determination to delist its common stock after the company failed to regain compliance with Nasdaq Listing Rule 5550(b)(1), which requires at least $2.5 million in stockholders’ equity or specified alternative criteria.

Nasdaq previously gave the company until November 19, 2025 to regain compliance, but a letter dated November 20, 2025 states that the company remains non-compliant.

Unless Moleculin requests a hearing before a Nasdaq panel by November 28, 2025, its securities are scheduled to be delisted on December 2, 2025. The company intends to appeal this determination under Nasdaq’s procedures, and its common stock is expected to continue trading on The Nasdaq Capital Market under the symbol “MBRX” while the appeal is pending.

Moleculin Biotech reported progress in its pivotal Phase 2B/3 MIRACLE study of Annamycin plus cytarabine for adult AML patients who are refractory to or relapsed after induction therapy. As of November 4, 2025, 60% of the target number of subjects for the first planned interim unblinding had consented.

The first interim unblinding targets 45 subjects. The company expects to complete treatment of these first 45 subjects in Q1 2026, with the initial unblinding of data thereafter. Identification and recruitment are ongoing. The update was announced via press release furnished as Exhibit 99.1.

Moleculin Biotech, Inc. (MBRX) reported that it entered into a research and material transfer agreement with the University of North Carolina at Chapel Hill to support investigator‑initiated preclinical research evaluating Annamycin for the treatment of pancreatic cancer. The company furnished this update via an 8‑K, noting that the related press release is attached as Exhibit 99.1.

The disclosure is provided under a furnished information item and is not deemed filed. This agreement enables UNC investigators to conduct preclinical studies of Annamycin in pancreatic cancer models, reflecting continued nonclinical development activity around Moleculin’s anthracycline candidate.

Moleculin Biotech (MBRX) furnished a corporate presentation under Regulation FD (Item 7.01), included as Exhibit 99.1. The presentation is posted on the company’s website and the exhibit is being furnished, not filed, which means it is not incorporated into other Securities Act or Exchange Act filings unless expressly stated.

Moleculin Biotech, Inc. (MBRX) announced a new patent grant in Australia. The company reported that IP Australia has granted Patent No. 2024203598 titled “PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE,” covering certain preliposomal Annamycin lyophilizates with improved stability and high purity.

The patent’s base term currently extends until June 2040, with potential extension to account for time required to fulfill regulatory approval requirements. The company furnished a press release with further details as an exhibit.

Moleculin Biotech reported that it entered into an agreement with Atlantic Health System to begin an investigator-initiated Phase 1B/2 single-arm study of Annamycin for third-line treatment of advanced pancreatic cancer. This design allows a clinical site to lead the study while evaluating Annamycin in a heavily pretreated setting.

The announcement was furnished under Item 7.01, with the related press release included as Exhibit 99.1. Because it is furnished rather than filed, it is intended for informational purposes. No financial terms or clinical timelines are included in the disclosure.

Moleculin Biotech, Inc. (MBRX) reported stockholder voting results from its Special Meeting. Holders approved the Nasdaq Proposal authorizing the issuance of up to 64,864,864 shares upon exercise of certain warrants issued on August 28, 2025. The proposal passed with 4,937,555 votes for, 1,479,087 against, and 142,257 abstentions, with 8,178,900 broker non-votes.

Stockholders did not approve changing the company name to Moleculin Inc., which required a majority of outstanding shares. The name proposal received 11,258,199 for, 843,364 against, and 2,636,236 abstentions. An adjournment proposal was approved with 5,589,386 for, 806,047 against, and 163,466 abstentions. As of August 28, 2025, there were 36,739,360 shares outstanding; 14,737,799 shares were present or represented by proxy, constituting a quorum.

Moleculin Biotech, Inc. filed a current report describing new intellectual property progress for its drug candidate Annamycin. The company announced that the Canadian Intellectual Property Office has issued a notice of intent to grant Patent Application No. 3,142,510, titled “PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE.” A patent from this application is expected to be issued in the coming months, which would strengthen Moleculin’s patent protection for this formulation in Canada.

Moleculin Biotech announced updates to its pivotal Phase 2B/3 trial ("MIRACLE") evaluating Annamycin combined with cytarabine ("AnnAraC") for adults with relapsed or refractory acute myeloid leukemia (R/R AML). The company reported active site status and recruitment updates for the multi-center, randomized, double-blind, placebo-controlled, adaptive-design study. The MIRACLE trial is described as a global approval trial with sites in the U.S., Europe and the Middle East. A press release providing these trial updates is attached to the report as Exhibit 99.1 and is furnished with the filing.