What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-13 compared with 2025-08-12 · 166 added, 116 removed, 195 unchanged (59% of the section changed)

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

The need to obtain and retain regulatory approval of our drug candidates, both in the United States and in Europe, and in countries deemed necessary for future trials;

The need to obtain and retain regulatory approval of our drug candidates, both in the US and in Europe, and in countries deemed necessary for future trials;

Our ability to complete our clinical trials in a timely fashion in line with our stated milestones and within our expected budget and resources;

Our ability to maintain compliance with the continued listing requirements of the Nasdaq Capital Market;

Our ability to regain in the short-term, and then maintain, compliance with the continued listing requirements of the Nasdaq Capital Market;

Our ability to source our drug products at reasonable prices;

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Furthermore, we cannot guarantee future results, events, levels of activity, performance, or achievements.

We are a late-stage pharmaceutical development company currently conducting a pivotal Phase 3 trial evaluating Annamycin (also known by its non-proprietary name "naxtarubicin") in combination with Cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML).

This Phase 3 trial should have an interim unblinding of data by the end of 2025, less than a year from its commencement, and an additional unblinding in the first half of 2026.

We believe such early visibility for a pivotal registration-enabling trial is highly unique in that stakeholders will receive preliminary safety and efficacy data in the “MIRACLE” trial (derived from M olecul i n R /R AML A nnAraC Cl inical E valuation) within one year of dosing the first subject.

Additionally, we have two portfolios of technologies for hard-to-treat cancers and viruses with clinical and preclinical research funded by investigators at academic institutions.

We are a late-stage pharmaceutical development company currently conducting a pivotal Phase 3 trial evaluating Annamycin (also known by its non-proprietary name "naxtarubicin") in combination with Cytarabine for the second line (2L) treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML).

This Phase 3 trial plans to have an interim unblinding of data upon the recruitment of the first 45 subjects and the readout of the data from the sites, expected shortly thereafter.

We plan an additional unblinding on the first 90 subjects (includes the previously mentioned first 45 subjects).

We have two additional portfolios of technologies for hard-to-treat cancers and viruses currently with clinical and preclinical research funded by investigators at academic institutions.

Each of our three core technologies is based substantially on discoveries made at and licensed from MD Anderson in Houston, Texas, and features one or more drugs that have successfully completed a Phase 1 clinical trial.

Some of the intellectual property was co-developed by us with MD Anderson.

Three of our six drug candidates have shown human activity in clinical trials and are currently or have been in Phase 1B/2 or Phase 2 clinical trials.

One Phase 2B/3 trial is currently underway.

One Phase 2B/3 trial and one Phase 2 trial are currently underway.

Since our inception, our drugs have completed, are currently in, or have been permitted to proceed in, fourteen clinical trials.

This is expected to increase in 2026 with an expansion of treated indications with Annamycin.

Annamycin is in a class of drugs referred to as Anthracyclines, which are inhibitors of topoisomerase II, enabling them to cause DNA damage in rapidly replicating tumor cells.

Annamycin, in a unique multilamellar lipid formulation, is our lead molecule and we have recently concluded treating subjects in one Phase 1B/2 clinical trial for treating Acute Myeloid Leukemia (AML) and are embarking on a Phase 3 clinical trial for the treatment of AML, which we believe will be pivotal.

Annamycin has also been in two Phase 1B/2 clinical trials for treating Soft Tissue Sarcoma metastasized to the lungs (STS lung metastases, STS lung mets, or Advanced STS).

Annamycin, in a unique multilamellar lipid formulation, is our lead molecule and we have recently concluded treating subjects in several Phase 1B/2 clinical trial for treating AML and are embarking on a Phase 3 clinical trial for the treatment of AML, which we believe will be pivotal.

Annamycin has also been in two Phase 1B/2 clinical trials for treating Soft Tissue Sarcoma metastasized to the lungs (STS lung metastases, STS lung mets, STS or Advanced STS).

Our Phase 1B/2 STS lung mets trial MB-107 is completed, and a clinical study report has been issued.

The other trial is an investigator initiated Advanced STS trial which is closed to recruitment.

One of our core management beliefs is that anthracyclines represent one of the most important treatments for AML and Advanced STS, and we believe Annamycin may, for the first time ever, allow a majority of these patients to benefit from this treatment.

One of our core management beliefs is that anthracyclines represent one of the most important treatments for nearly half of all cancers, including AML and Advanced STS, and that Annamycin may increase the efficacy, safety and tolerability of anthracycline therapy fora majority of these patients.

We believe that such a benefit could be disruptive to the competitive landscape for these markets.

This belief, coupled with our limited resources, leads us to currently focus mainly on the development of Annamycin.

We intend to advance our other drug candidates via investigator led studies – both clinically and preclinically.

We intend to advance our other drug candidates via investigator led studies – both preclinically and clinically.

Focus and Core Technologies

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a) Annamycin or L-Annamycin is a “next generation” anthracycline (one of the most widely used classes of chemotherapy), designed to be different than currently approved anthracyclines, which are limited in utility because of cardiotoxicity risks and their susceptibility to multidrug resistance mechanisms.

Annamycin was designed to avoid multidrug resistance and to be non-cardiotoxic and, with intensive cardiac monitoring, has shown no cardiotoxicity in subjects treated in our five Annamycin clinical trials to date.

Annamycin was designed to avoid multidrug resistance and to be non-cardiotoxic and, with intensive cardiac monitoring, has shown no cardiotoxicity in subjects treated in our six Annamycin clinical trials to date.

Furthermore, we have demonstrated safe dosing significantly beyond the lifetime dose limitations imposed by regulatory authorities upon commonly prescribed anthracyclines due to their inherent cardiotoxicity.

The clinical activity for Annamycin is discussed below.

b) Our WP1066 Portfolio includes WP1066, WP1193 and WP1220, three of several Immune/Transcription Modulators in the portfolio designed to inhibit p-STAT3 (phosphorylated signal transducer and activator of transcription 3) among other transcription factors associated with tumor activity.

These also stimulate a natural immune response to tumors by inhibiting the errant activity of Regulatory T-Cells (TRegs).

These also stimulate a natural immune response to tumors by inhibiting the errant activity of Regulatory T-Cells (TRegs).We have an oral formulation of WP1066 that has been in three clinical trials to date and we are currently performing preclinical work on an intravenous formulation, all of which are funded and performed by investigator-initiated studies.

c) Our WP1122 Portfolio contains compounds (including WP1122, WP1096, and WP1097) designed to exploit the potential uses of inhibitors of glycolysis such as 2-deoxy-D-glucose (2-DG).

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Such data from clinical trials where a clinical study report has not yet been issued include some data which are preliminary and subject to change.

We received several independent assessments for the absence of cardiotoxicity in subjects treated with Annamycin.

We now have independent assessments covering 84 subjects that have been treated with Annamycin in five different clinical trials in the U.S.

and Europe with no evidence of cardiotoxicity.

We now have independent assessments covering 84 subjects that have been treated with Annamycin in five different clinical trials in the US and Europe with no evidence of cardiotoxicity.

To date of the 77 subjects treated in our internally funded trials, 56 were treated above the FDA’s lifetime maximum anthracycline limit of 550 mg/m 2 , including one subject whose repeated Annamycin treatments took that subject to a total cumulative anthracycline exposure of 3,420 mg/m 2 (or roughly five times the FDA approved lifetime anthracycline exposure) and there has been no evidence of cardiotoxicity reported.

After review of the data provided, the Independent Expert, in their most recent report and as stated in previous reports, concluded that there was no evidence of drug-related cardiotoxicity in any subjects.

After review of the data provided, the Independent Expert concluded that there was no evidence of drug-related cardiotoxicity in any subjects.

Furthermore, additional subjects have been treated in the MIRACLE trial and, to date, no cardiotoxicity has been observed, bringing the total subjects treated safely with Annamycin to almost 100 subjects.

We believe the Expert's reports are particularly relevant in light of a recently published retrospective study showing that the incidence of heart failure more than doubles for cancer patients treated with anthracyclines compared to cancer patients not receiving anthracyclines (C Larson, et al.

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2) Preclinical studies have demonstrated Annamycin lacks cardiotoxicity as compared to a currently prescribed anthracycline;

and, 3) Our Expert’s conclusions from analyzing the data from 84 subjects treated with Annamycin in five clinical studies conducted in the US and in Europe.

and, 3) Our Expert’s conclusions from analyzing the data from 84 subjects treated with Annamycin in five clinical studies conducted in the US and in the EU.

Our discussions will reflect any additional data or analyses as they become available.

Clinical Trials Summary

We have multiple active INDs/CTAs ("Investigational New Drug" authorization in the US or "Clinical Trial Authorization" in Europe).

We have multiple active INDs/CTAs ("Investigational New Drug" authorization in the US or "Clinical Trial Authorization" in other countries).

These INDs/CTAs are under development, approved, in progress, or completed and comprise a total of fourteen clinical trials, internally and externally funded.

With Annamycin, we currently have active two AML clinical trials:

MB-106 which is a Phase 1B/2 treating AML with AnnAraC (recruitment is closed and this trial is now in subject long-term follow-up) and MB-108 which is a Phase 2B/3 pivotal clinical trial treating R/R AML as 2 nd line therapy (recruitment has started and additional sites are being added).

Additionally, there is one externally funded Phase 1B/2 trial treating STS Lung Mets with Annamycin as monotherapy.

With Annamycin, we closed one AML clinical trial:

MB-106 which was a Phase 1B/2 treating AML with the combination of Annamycin and Cytarabine (together referred tp as “AnnAraC”).

The Clinical Study Report is now being written.

Additionally, MB-108 is a Phase 2B/3 pivotal clinical trial treating R/R AML as 2 nd line therapy (recruitment has started and additional sites are being added) with AnnAraC.

Finally, there is one externally funded Phase 1B/2 trial treating STS Lung Mets with Annamycin as monotherapy.

This trial is closed and is in follow-up on the trial’s subjects.

With WP1066, we have an externally funded Phase 1B/2 trial in combination with radiation treating glioblastoma (GBM) at Northwestern University that is actively recruiting.

With WP1066, we have an externally funded a Phase 1B/2 trial in combination with radiation treating glioblastoma (GBM) at Northwestern University that is active.

MIRACLE Trial

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Clinical and Regulatory

As of July 25, 2025, we have selected over 35 sites to conduct Part A of the MIRACLE trial in the US, the European Union (EU) and Eastern Europe.

Four sites (one each in Ukraine, the country of Georgia, Spain and the US) are actively recruiting, screening and/or treating subjects.

Besides these four sites the MIRACLE trial has been submitted to or has been approved by over 25 ethics committees of various clinics in the US and the EU.

Eight subjects have been treated as of July 25, 2025 in the randomized, three-arm, blinded MIRACLE trial.

This build-up to over 35 sites in the targeted countries of Ukraine, Georgia, US, Romania, Spain, Lithuania, Poland, Italy and Czechia should accelerate in August and September supporting our maintenance of our target for recruiting the first 45 subjects in Part A and unblinding the top line results in the second half of 2025.

On November 13, 2025, we announced an update, as of November 4, 2025, on recruitment for MIRACLE with 60% of the targeted 45 subjects consented into the trial with additional subjects identified by site investigators.

We believe that the blinded complete remission response activity to date is within the randomized expectations, based on historical clinical data for the treatment arms.

The currently consented subjects are from across sites in five countries, providing a diverse base of subjects.

With the upcoming holidays in addition to unexpected bed shortages at certain EU sites, we expect treatment of the last of the first 45 subjects in the first quarter of 2026.

Such data will be audited, locked, and reviewed prior to release.

The release of the unblinded data will be thereafter.

The final unblinded data of the first 90 subjects will be the basis for the Data Safety Monitoring Committee’s (DSMC) recommendation of the treatment arms going forward and, most importantly, on any needed actions related to subject safety.

Subjects have been identified in the US, and to date, none have passed our pre-screening protocol.

We announced on September 9, 2025, updates to our site status and recruitment and as of early September 2025, 13 subjects had been screened, enrolled, or dosed, with a target of reaching 20 active/screening sites by month-end.

On September 1, 2025, and treated our first subject in the European Union (EU).

As of July 25, 2025, we selected over 35 sites to conduct Part A of the MIRACLE trial in the US, the EU, and Eastern Europe.

Four sites (one each in Ukraine, the country of Georgia, Spain and the US) were actively recruiting, screening and/or treating subjects.

Besides these four sites the MIRACLE trial was approved by over 25 ethics committees of various clinics in the US and the EU.

Eight subjects were treated as of July 25, 2025 in the MIRACLE trial.

Since February and through October of 2025, we received a total of ten separate communications from the FDA including additional comments and information requests, all of which we addressed.

These requests focused mainly on safety, subject monitoring, clinical pharmacology, statistics, and inclusion/exclusion criteria.

None of the requests resulted in significant changes to overall trial design or dosing of Annamycin.

Such requests require from time to time, an update to our protocol, which must be processed through each regulatory/clinical jurisdiction, and we believe such requests and responses will continue as we progress the MIRACLE trial through multiple countries.

The US and EU protocols with the FDA and EMA, respectively, are currently “harmonized” and future requests as we proceed may require future “harmonization”.

In November 2024, we amended our existing US investigational new drug application or IND for inclusion of the MIRACLE trial protocol.

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Any reduction in recruitment enables shortening the time for completion of the trial.

In February through April of 2025, we received a total of five separate communications from the FDA including additional comments and information requests, all of which we believe we have adequately addressed.

These requests focused mainly on safety, subject monitoring, clinical pharmacology, and inclusion/exclusion criteria.

None of the requests focused on the overall trial design or dosing of Annamycin.

Our last response was submitted on April 18, 2025 and we have not received follow-up communication since that time.

However, we cannot be assured that our responses will be adequate for the FDA to continue to allow the amended IND to proceed, or that there will not be additional requests for information.

Because we are amending an existing IND, there is no required time for the FDA to respond to our submissions, but neither is a positive FDA response required for us to proceed with the MIRACLE trial.

At this time, we will proceed with the MIRACLE trial, as amended, in the US.

As with all clinical trials, if at any time the FDA believes there is a safety issue that merits it, the agency may put the MIRACLE trial on clinical hold.

Expands Phase 3 MIRACLE Clinical Trial into the Country of Georgia

On July 9, 2025, we announced that the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in the country of Georgia has approved our Clinical Trial Application (CTA) to conduct the MIRACLE trial, further expanding our active sites beyond Ukraine.

Receives European Medicines Agency Approval to Expand Phase 3 MIRACLE Clinical Trial

On May 12, 2025, we announced that the European Medicines Agency (EMA) approved its Clinical Trial Application to conduct its MIRACLE trial in all nine countries submitted in the European Union (EU).

On May 12, 2025, we announced that the European Medicines Agency (EMA) approved its Clinical Trial Application to conduct the MIRACLE trial in all nine countries submitted in the European Union (EU).

We received the final Report for the Application and Evaluation Assessment (part of the EMA’s Clinical Trial Information System or CTIS process) of "Acceptable" for Belgium, Czechia, France, Germany, Italy, Lithuania, Poland, Romania, and Spain.

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Such results will be submitted as a substantial modification.

Along with the individual country committee and/or ethics approvals for these nine countries in the EU allows us to proceed.

Along with the individual country committee and/or ethics approvals for these nine countries in the EU, this allows us to proceed.

While there are minor differences between the US and EU protocols with the FDA and EMA, respectively, we do not view these as a barrier to conducting the study and are working to harmonize the protocols as appropriate.

MB-106 Clinical Study with AnnAraC for the Treatment of AML (1st through 7th Linse Subjects)

We completed our Phase 1B/2 (MB-106) clinical trial evaluating AnnAraC for the treatment of subjects with AML with the database for the trial locked in September 2025.

The data below is subject to the final Clinical Study Report (CSR) being published which is projected to be in the first quarter of 2026.

In total, 23 subjects were enrolled and 22 dosed in the trial, with all subjects (1st Line through 7th Line or 1L-7L) who received AnnAraC per protocol having completed their efficacy evaluations (n=20).

The updated overall survival (OS) data revealed the following:

Median OS for Complete Remissions (CR):

Technically median OS was not met as 50% of the subjects in the CR population were alive at study close.

A median OS of 15+ months (n=8) was reported at study close with 4 subjects alive.

Median OS for the intent to treat (ITT) Safety Population (1L-7L):

9 months (n=22;

13 subjects experienced an event, 9 subjects censored)

Median OS for 2L Safety Evaluable Population:

12 months (n=9)

Industry publications note that the typical OS for relapsed AML patients is roughly 4-6 months.

As previously reported, 8 subjects in the intent-to-treat (ITT) population of 22 (36%) achieved a complete remission (CR) following treatment with AnnAraC.

Among the subjects treated in the second line (2L) setting (n=10), the CR rate (the same primary efficacy endpoint as in the ongoing Phase 2B/3 pivotal MIRACLE trial), was 50%.

Median durability for the 8 subjects achieving a CR was 10 months and continuing at the end of the study.

CR durability ranged from 2 months to 22 months and continuing.

CRs were achieved in subjects with a variety of prior treatments, including traditional 7+3 and venetoclax regimens.

This data is considered preliminary until a final CSR is published.

Pediatric Study for Annamycin in Combination Therapy with Cytarabine for the Treatment R/R AML

Received Positive FDA Feedback on Pediatric Study Plan for Annamycin in Children with R/R AML

We announced on June 18, 2025, we received a written response from the Office of Oncologic Diseases – Pediatric Oncology of the FDA regarding our Initial Pediatric Study Plan (iPSP), which was submitted after a June 2024 end-of-phase 1/2 meeting.

We announced on June 18, 2025, that we received a written response from the Office of Oncologic Diseases – Pediatric Oncology of the FDA regarding our Initial Pediatric Study Plan (iPSP), which was submitted after a June 2024 end-of-phase 1/2 meeting.

The FDA has agreed to a single pediatric approval study in which Annamycin (also known as naxtarubicin) in combination with Cytarabine will be evaluated as second line therapy in pediatric patients with R/R AML.

Believing that this is particularly important in pediatric oncology because about 60% of children with cancer are treated with anthracyclines that present a high risk of causing heart damage, we expect to commence this trial in the second half of 2027.

We believe that this is particularly important in pediatric oncology because about 60% of children with cancer are treated with anthracyclines that present a high risk of causing heart damage, we expect to commence this trial in the second half of 2027.

As part of the iPSP, we proposed a single-arm study evaluating pharmacokinetics (PK), efficacy, and safety of AnnAraC in patients between 2 and 16 years of age.

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Importantly, FDA said we would be able to start the pediatric trial before having the full two years of follow-up data from the adult trial.

We processed the updates to our iPSP to incorporate FDA’s recommendations and have received additional FDA comments, which we consider to be minor, to process.

Between August 2025 and September 2025, we corresponded with the FDA regarding certain specifics of this trial.

On September 26, 2025 we received the iPSP agreement letter from the FDA.

MB-107 Annamycin in Monotherapy for the Treatment of STS Lung Mets

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The Oncologist 2017;22:1518–1527).

Investigator-Initiated Study Annamycin for the Treatment of Pancreatic Cancer

On November 2025 we announced grant funded research evaluating Annamycin for the treatment of pancreatic cancer at University of North Carolina - Chapel Hill (UNC).

In early November we entered into a research and material transfer agreement with the UNC for investigator-initiated preclinical research evaluating Annamycin for the treatment of pancreatic cancer.

The studies covered under this agreement will evaluate the ability of novel treatment agents and modalities to enhance the tumor delivery of liposomal Annamycin (L-Annamycin) and Free-Annamycin as compared to Doxil and Free-doxorubicin in the PDAC GEMM models.

Under the terms of the agreement the Company will supply Annamycin and the UNC Eshelman School of Pharmacy, UNC Lineberger Comprehensive Cancer Center, and Carolina Institute of Nanomedicine will conduct the planned preclinical research as part of a series of funded grants .

On October 23, 2025, we announced that the Company is working with Atlantic Health on an investigator-initiated Phase 1B/2 single-arm study evaluating Annamycin for third-line (3L) treatment of advanced pancreatic cancer.

Pancreatic cancer continues to present significant treatment challenges, being the cancer with the highest mortality rate globally and the seventh leading cause of cancer death.

However, recent preclinical studies indicate that Annamycin may target critical factors associated with this disease, showcasing its potential as a novel therapeutic option.

In connection with the planned study, Moleculin will supply Annamycin and be responsible for submitting and maintaining an Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA), and Atlantic Health will be responsible for conducting the Phase 1B/2 study.

Moleculin estimates the additional cost to run this trial from 2026 into 2030 (for long-term follow-up) will be approximately $1 million, mainly for drug supply and outside laboratory testing.

This trial is subject to the successful filing of an IND with the FDA, both parties agreeing on a clinical trial agreement, ensuring sufficient drug supply and other critical items leading up to expected commencement of the clinical trial in 2026.

Scientific Presentations of Preclinical Data

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This is an investigator-initiated trial where our main cost is supplying drug product.

To date Northwestern has recruited 7 subjects, of which 5 have completed treatment and are undergoing follow-up while 2 continue with treatment.

As of the end of October 2025, Northwestern had recruited 8 subjects, of which 3 were active with treatment, 1 off treatment and in follow-up, and 4 off study.

No data has been released.

Preclinical Studies with WP1066 IV Formula at Emory University

We have signed an agreement with Emory University whereby Emory will study various WP1066 IV formulations in preclinical studies with the goal of selecting the best molecule to move into a clinical setting towards, most likely, brain cancers such as GBM.

Study drug was delivered in April 2025 to Emory with results from such studies expected in the second half of 2025.

This initial enrollment was part of a "lead-in safety analysis".

The safety committee has approved moving forward and, pending approval from the study statistician, the study will proceed with further enrollment.

Prior Pediatric Brain Tumor Study and Preclinical Studies with WP1066 IV Formula at Emory University

A manuscript covering the prior pediatric study for WP1066 treating brain tumors conducted at Emory University has been drafted and was accepted for publication, expected in the second half of 2026.

We signed an agreement with Emory University whereby Emory will study various WP1066 IV formulations in preclinical studies with the goal of selecting the best molecule to move into a clinical setting towards, most likely, brain cancers such as GBM.

Study drug was delivered in April 2025 to Emory.

The protocol for the in vitro and in vivo studies were approved internally.

The in vitro studies should be completed in the fourth quarter of 2025 and the in vivo studies should be completed in the first half of 2026.

Other Corporate

Additional Patent for Annamycin in the EU

Additional Patents for Annamycin in the EU, Canada and Australia

On October 29, 2025, we announced that the Australian Patent Office (IP Australia) has granted Patent No.

2024203598 titled, " PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE ," with claims covering certain preliposomal Annamycin lyophilizates with improved stability and high purity, with a base patent term currently extending until June 2040, subject to extension to account for time required to fulfill requirements for regulatory approval.

We announced on September 25, 2025, that the Canadian Intellectual Property Office (CIPO) issued a notice of allowance for our patent application.

A patent from the application is expected to be issued in the coming months.

On July 30, 2025, we announced that we received a Notice of Intent to Grant for the European patent application titled, " PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE ." Such grant should solidify the Company’s European Union exclusivity of Annamycin.

The grant is subject to payment of fees and completion of final amendments and formalities.

When issued, the patent claims will cover methods of making a preliposomal Annamycin lyophilizate with improved stability and high purity, with a base patent term currently extending until into 2040, subject to extension to account for time required to fulfill requirements for regulatory approval.

In addition to the newly expected European patent and previously issued U.S.

patents, we have additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.

When issued, the patent claims will cover methods of making a preliposomal Annamycin lyophilizate with improved stability and high purity, with a base patent term currently extending into 2040, subject to extension to account for time required to fulfill requirements for regulatory approval.

In addition to the newly expected European patent and previously issued US patents, we have additional patent applications related to Annamycin pending in the US, Europe and in major jurisdictions worldwide.

World Health Organization Approval of “naxtarubicin” as International Non-Proprietary Name for Annamycin

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Additional Patents Issued for Annamycin in the US

We announced on May 5, 2025, that the U.S.

Patent and Trademark Office (USPTO) granted two additional U.S.

patents with claims covering Annamycin.

patent number 12,257,261 titled, “ Preparation of Preliposomal Annamycin Lyophilizate ”, has claims covering methods of making liposomal Annamycin and U.S.

patent 12,257,262 titled “ Method of Reconstituting Liposomal Annamycin “, has claims covering methods of making liposomal Annamycin suspension.

We announced on May 5, 2025, that the US Patent and Trademark Office (USPTO) granted two additional US patents with claims covering Annamycin.

US patent number 12,257,261 titled, “ Preparation of Preliposomal Annamycin Lyophilizate ”, has claims covering methods of making liposomal Annamycin and US patent 12,257,262 titled “ Method of Reconstituting Liposomal Annamycin “, has claims covering methods of making liposomal Annamycin suspension.

Both patents have a base patent term currently extending until June 2040, subject to adjustment for delays in prosecution and extension to account for time required to fulfill requirements for regulatory approval.

Moleculin has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.

Moleculin has additional patent applications related to Annamycin pending in the US, Europe and in major jurisdictions worldwide.

On March 6, 2025, we announced that we received a Notice of Intent to Grant for the European patent application titled, “ Method of Reconstituting Liposomal Annamycin “.

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When issued, the patent claims will cover methods of making liposomal Annamycin suspension as well as the resulting compositions for use in the treatment of cancers, with a base patent term currently extending until June 2040, subject to extension to account for time required to fulfill requirements for regulatory approval.

In addition to the expected European patent and previously issued U.S.

patents, Moleculin has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.

In addition to the expected European patent and previously issued US patents, Moleculin has additional patent applications related to Annamycin pending in the US, Europe and in major jurisdictions worldwide.

Licenses and Sponsored Research with MD Anderson

We have terminated certain licenses related to WP1122 with MD Anderson and are in discussions to execute an option or options on these technologies along with additional technologies where the term of such options will be tied to the term of our Sponsored Research Agreement with MD Anderson.

Such actions are in line with our efforts to focus our resources on the development of Annamycin.

We terminated certain licenses related to WP1122 with MD Anderson and began discussions to execute an option or options on these technologies along with additional technologies where the term of such options will be tied to the term of our Sponsored Research Agreement with MD Anderson.

In October 2025, we executed with MD Anderson separate options on intellectual property licenses for WP1122 for treatment of viral infections and on an intravenous formulation for the WP1066 portfolio.

Both of these technologies were co-developed by MD Anderson and Company personnel.

These options are linked to the Company continuing certain sponsored research at MD Anderson for the next two years.

Results of Operations

The following table sets forth, for the periods indicated, data derived from our statement of operations (table in thousands) and such changes in the periods are discussed below in approximate amounts:

During the third quarter of 2025, the Company elected to change its accounting policy for certain outstanding warrants from the liability method to accounting for warrants under the equity method.

Management believes this change is preferable as it reflects the economic substance of the arrangement with that of an equity instrument and enhances the consistency of the Company's financial reporting.

The effects of the change in accounting method have been retrospectively applied to all periods presented in all sections of this Form 10-Q, including Management's Discussion and Analysis.

Refer to Note 2, "Basis of presentation, principles of consolidation, and significant accounting policies and liquidity" in Item 1 of this Form 10-Q for further information related to the change in accounting principle.

The following table sets forth, for the periods indicated, data derived from our condensed consolidated statement of operations (table in thousands) and such changes in the periods are discussed below in approximate amounts:

Moleculin Biotech, Inc.

Condensed Consolidated Statements of Operations

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Operating expenses:

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Interest income, net

1 WHO Drug Information, Vol.

Three Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024

Three Months Ended September 30, 2025 Compared to Three Months Ended September 30, 2024

Research and Development Expense.

Research and development (R&D) expense was $3.6 million and $4.1 million for the three months ended June 30, 2025 and 2024 , respectively.

The decrease of $0.5 million is mainly related to a reduction in the clinical trials activity.

Research and development (R&D) expense was $3.7 million and $4.9 million for the three months ended September 30, 2025 and 2024 , respectively.

The decrease of $1.2 million is mainly related to lower drug production costs during the current quarter as compared to the prior year quarter due to timing of production and offset by higher clinical operations costs in the current period quarter.

General and Administrative Expense.

General and administrative e xpense was $2.1 million each for the three months ended June 30, 2025 and 2024 .

General and administrative e xpense was $2.1 million and $2.2 million for the three months ended September 30, 2025 and 2024 , respectively.

The decrease of $0.1 million is mainly related to higher consulting costs and investor relations expenses offset by lower salaries and bonuses and lower stock-based compensation expense.

Gain from Change in Fair Value of Warrant Liability.

We recorded a net gain of $9.6 million in the second quarter of 2025 as compared to a net gain of $1.7 million in the second quarter of 2024, for the change in fair value on revaluation of our warrant liability associated with our warrants issued in conjunction with certain of our previous stock offerings.

We are required to revalue our liability-classified warrants at the time of each warrant exercise, if applicable, and at the end of each reporting period and reflect in the statement of operations a gain or loss from the change in fair value of the warrant in the period in which the change occurred.

We calculated the fair value of the warrants outstanding using the Black-Scholes model.

A gain results principally from a decline in our share price during the period and a loss results principally from an increase in our share price.

We recorded a net gain of $1.6 million in the third quarter of 2025 due to the change in fair value of the warrant liability.

The liability-classified warrants are valued at the time of each warrant issuance date, if applicable, and at the end of each reporting period.

Changes in fair value are reflected in the statement of operations as a gain or loss from the change in fair value of the warrant in the period in which the change occurred.

A gain results principally from a decline in our share price during the period and a loss will result principally from an increase in our share price.

Transaction costs allocated to warrant liabilities and Loss on issuance of warrant liabilities.

Proceeds of offerings are allocated between common shares and warrants first by allocating to the warrants classified as a liability based on their fair value and then allocating the residual to the equity instruments, which would include pre-funded warrants.

As the fair value of the liability classified warrants in the June 2025 offerings exceeded the total proceeds, no consideration was allocated to the common shares or pre-funded warrants.

The full proceeds of the June 2025 offering was recorded to warrant liabilities, with an initial liability of $16.4 million, and a loss on initial recognition of $10.4 million.

Transaction costs related to the offering were correspondingly fully allocated to warrant liabilities, and $1.2 million in related transaction costs were expensed during the three months ended June 30, 2025.

Transaction costs on the Series F warrants in August 2025 amounted to $0.5 million as compared to no loss in the prior quarterly period.

The loss on issuance of the warrant liabilities for the Series F warrants was $20.6 million as compared to no loss for the prior quarterly period in 2024.

Interest income, net.

Interest income, n e t decreased by approximately $0.1 million f or the comparable quarterly periods due to a decreasing cash balance and decreasing interest rates during the past year.

Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024

Nine Months Ended September 30, 2025 Compared to Nine Months Ended September 30, 2024

Research and Development Expense.

Research and development (R&D) expense was $7.0 million and $8.3 million for the six months ended June 30, 2025 and 2024 , respectively.

The decrease of $1.3 million is mainly related to a reduction in the clinical trials activity.

Research and development (R&D) expense was $10.8 million and $13.3 million for the nine months ended September 30, 2025 and 2024 , respectively.

The decrease of $2.5 million is mainly related to increased clinical operations costs offset by lower drug production costs for the comparable nine month period.

General and Administrative Expense.

General and administrative e xpense was $4.6 million and $4.5 million for the six months ended June 30, 2025 and 2024 , respectively.

The increase of $0.1 million is mainly related to a slight overall increase in regulatory and legal fees.

General and administrative e xpense was $6.7 million and $6.6 million for the nine months ended September 30, 2025 and 2024 , respectively.

The increase of $0.1 million is mainly related to lower salary and bonus costs for the comparable nine month period, offset by increased consulting and investor relations expenses.

Gain from Change in Fair Value of Warrant Liability.

We recorded a net gain of $18.7 million in the six months ended June 30, 2025 as compared to a net gain of $3.2 million in the six months ended June 30, 2024, for the change in fair value on revaluation of our warrant liability associated with our warrants issued in conjunction with certain of our previous stock offerings.

We calculated the fair value of the warrants outstanding using the Black-Scholes model.

We recorded a net gain of $1.6 million for the nine months ended September 30, 2025 as compared to a net gain of $1.0 million in the nine months ended September 30, 2024, due to the change in fair value on revaluation of our warrant liability.

We are required to revalue our liability-classified warrants at the time of each warrant issuance, if applicable, and at the end of each reporting period and reflect in the statement of operations a gain or loss from the change in fair value of the warrant in the period in which the change occurred.

We calculated the fair value of the warrants outstanding using the Monte Carlo model for Series E and F warrants.

A gain results principally from a decline in our share price during the period and a loss results principally from an increase in our share price.

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As the fair value of the liability classified warrants in the June 2025 and February 2025 offerings exceeded the total proceeds, no consideration was allocated to the Common Shares or Pre-Funded Warrants.

The full proceeds of the June 2025 and February 2025 offerings were recorded to warrant liabilities, with initial liabilities of $35.4 million, and losses on initial recognition of $18.2 million.

Transaction costs related to the offering were correspondingly fully allocated to warrant liabilities, and $3.0 million in related transaction costs were expensed during the six months ended June 30, 2025.

As the fair value of the liability classified warrants exceeded the total proceeds, no consideration was allocated to the common shares or pre-funded warrants.

The full proceeds of the Series E and F warrants were recorded to warrant liabilities.

Transaction costs for the nine months ended September 30, 2025 was $1.7 million which included the Series E and F warrants as compared to the nine month period ended September 30, 2024.

In addition, the loss on issuance on warrant liabilities was $31.0 for the nine months ended September 30, 2025 on the Series E and F warrants as compared to none for the prior nine months ended September 30, 2024.

Interest income, net.

Interest income, n e t decreased by approximately $0.3 million f or the comparable quarterly periods due to a decreasing cash balance and decreasing interest rates during the past year.

Interest income, n e t decreased f or the comparable quarterly periods due to a decreasing cash balance and decreasing interest rates during the past year.

Liquidity and Capital Resources

The following table sets forth our primary sources and uses of cash for the period indicated (table in thousands):

Six Months Ended June 30,

Nine Months Ended September 30,

Net cash used in operating activities

Net cash used in investing activities

Net cash provided by (used in) financing activities

Net cash provided by financing activities

Effect of exchange rate changes on cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

As of June 30, 2025, there w as $0.03 million of cash on hand in a bank account in Australia and we know of no related limitations impacting our liquidity in Australia.

As of September 30, 2025, there w as $0.03 million of cash on hand in a bank account in Australia and we know of no related limitations impacting our liquidity in Australia.

Cash used in operating activities

Cash used in operations was $10.1 million for the six months ended June 30, 2025 .

This $2.6 million decrease over the prior year period of $12.7 million was primarily due to the timing of costs incurred and associated payments for drug production and clinical trial expenses.

Cash used in operations was $17.4 million for the nine months ended September 30, 2025 .

This $1.4 million decrease over the prior year period of $18.8 million was primarily due to the timing of costs incurred and associated payments primarily for clinical trial expenses and drug production costs.

Cash provided by fin ancing activities

In August 2025, we entered into a warrant exercise inducement offer letter with holders of certain existing warrants pursuant to which the holders agreed to exercise Series E warrants to purchase up to 16,216,216 shares of common stock with an exercise price of $0.37 per shares in exchange for the Company issuing new Series F warrants for the purchase of 64,864,864 shares of our common stock.

Each Series F warrant had an initial exercise price of $0.55 per share and was exercisable as of the date of issuance to October 16, 2030.

We received gross proceeds of $6.0 million.

In addition, during August and September 2025, 2,996,192 shares of Series E warrants were exercised for $1.1 million.

The Series F warrants are classified as liability warrants within our consolidated condensed interim financial statements.

In July 2025, we entered into an at-the-market equity agreement (the 2025 ATM Agreement) with Roth Capital Partners, LLC (Roth).

Pursuant to the terms of the 2025 ATM Agreement, the Company may offer and sell shares of our common stock having an aggregate offering price of up to $6.5 million from time to time through or to Roth acting as our sales agent or principal.

Pursuant to the terms of the 2025 ATM Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $6.5 million from time to time through or to Roth acting as our sales agent or principal.

Roth may also sell shares of our common stock in negotiated transactions at market prices prevailing at the time of sale at prices related to such prevailing market prices.

We paid a commission to Roth equal to 3.0% of the gross proceeds from the sale of our common stock under the 2025 ATM Agreement.

We will pay a commission to Roth equal to 3.0% of the gross proceeds from the sale of our common stock under the 2025 ATM Agreement.

We sold 736,549 shares of common stock pursuant to the 2025 ATM agreement in October for gross proceeds of $0.4 million at prices ranging from $0.4349 to $0.5601.

In June 2025, we completed a public offering for the sale of 9,972,026 shares of common stock, and 6,107,974 pre-funded warrants to purchase shares of common stock, and Series E warrants to purchase up to 48,240,000 shares of common stock.

The combined purchase price for the securities was $0.37 per share of common stock (or pre-funded warrant in lieu thereof).

Each Series E Warrant will be exercisable upon the receipt of shareholder approval, will have an exercise price of $0.37 per share, and expire five years from the initial exercise date.

The Company received gross proceeds of $5.9 million and up to an additional approximately $17.8 million in gross proceeds if the warrants are fully exercised for cash.

On February 25, 2025, we entered into a securities purchase agreement with an institutional investor for the sale by the Company of 1,150,000 shares of common stock, and 2,121,029 pre-funded warrants to purchase shares of common stock, and series D warrants to purchase up to 6,543,058 shares of common stock.

Each Series E warrant has an exercise price of $0.37 per share, and expires five years from the initial exercise date, or August 18, 2030.

We received gross proceeds of $5.9 million and we may receive up to an additional approximately $17.8 million in gross proceeds if the Series E warrants are fully exercised for cash.

On February 25, 2025, we entered into a securities purchase agreement with an institutional investor for the sale of 1,150,000 shares of common stock, and 2,121,029 pre-funded warrants to purchase shares of common stock, and Series D warrants to purchase up to 6,543,058 shares of common stock.

The combined purchase price for the securities was $1.07 per share of common stock (or pre-funded warrant in lieu thereof).

Each pre-funded warrant is exercisable for one share of common stock at an exercise price of $0.001 per share.

The pre-funded warrants are exercisable immediately and may be exercised at any time until all of the pre-funded warrants are exercised in full, subject to the beneficial ownership limitation.

Each common warrant will be exercisable upon the receipt of shareholder approval, will have an exercise price of $1.07 per share, and expire five years from the initial exercise date.

Each pre-funded warrant was exercisable for one share of common stock at an exercise price of $0.001 per share.

All pre-funded warrants were exercised in June 2025.

Each Series D warrant has an exercise price of $1.07 per share, and expire five years from the initial exercise date, or August 18, 2030.

We received gross proceeds of $3.5 million.

All prefunded warrants were exercised in June 2025.

On February 13, 2025, we entered into a warrant exercise inducement offer letter with a holder of certain existing warrants to receive new warrants to purchase up to a number of shares of common stock equal to 200% of the number of warrant shares issued pursuant to the exercise of such existing warrants to purchase up to 5,828,570 shares of common stock (series C warrants) pursuant to which the Holder agreed to exercise for cash their existing warrants at a reduced exercise price of $1.00 in exchange for our agreement to issue the inducement warrants to purchase up to 11,657,140 shares of the Company's common stock.

Each inducement warrant will have an exercise price of $0.75, and will be exercisable as of the date of issuance and may be exercised for a period of five years therefrom.

On February 13, 2025, we entered into a warrant exercise inducement offer letter with a holder of certain existing warrants to receive new warrants to purchase up to a number of shares of common stock equal to 200% of the number of warrant shares issued pursuant to the exercise of such existing warrants to purchase up to 5,828,570 shares of common stock (Series C warrants) pursuant to which the warrant holder agreed to exercise for cash their existing warrants at a reduced exercise price of $1.00 in exchange for our agreement to issue the inducement warrants to purchase up to 11,657,140 shares of our common stock.

Each inducement warrant has an exercise price of $0.75, and is exercisable as of the date of issuance and may be exercised for a period of five years from the date of issuance.

We received gross proceeds of $5.8 million.

This brings the total gross proceeds received in February 2025 to $9.3 million.

This brought the total gross proceeds received in February 2025 to $9.3 million.

On August 19, 2024, we completed a public offering of 283,000 shares of common stock and 2,183,368 pre-funded warrants to purchase shares of common stock, Series A warrants to purchase up to 2,466,368 shares of common stock and Series B warrants to purchase up to 2,466,368 shares of common stock, at a combined public offering price of $2.23 per share (or per pre-funded warrant in lieu thereof) and accompanying warrants.

We received gross proceeds of $5.5 million, before deducting the placement agent's fees and other offering expenses.

We believe that our cash on hand and cash equivalents as of June 30, 2025, is sufficient to fund our planned operations into the fourth quarter of 2025.

We believe that our cash on hand and cash equivalents as of September 30, 2025, is sufficient to fund our planned operations into the first quarter of 2026.

This takes into account cash outlays for preparations for clinical trials beyond the current active trials.

The continuation of our Company as a going concern is dependent upon our ability to obtain necessary financing to continue operations and the attainment of profitable operations.

We must seek additional funding of approximately $10 million to support MIRACLE and our operations into the first quarter of 2026 through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof to continue our operations in the near term.

We must seek additional funds of approximately $7 million, to support MIRACLE and our operations into the second quarter of 2026 through the combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof to continue our operations in near term.

We cannot provide assurance that such events or a combination thereof can be achieved.

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We cannot predict when this matter will be resolved or what, if any, action the SEC may take following the conclusion of the investigation.

We expensed approximate

million and $0.1 million in related general and administrative fees and expenses for the three months ended

June 30, 2025 and 2024

, respectively, and approximate

million and $0.1 million in related general and administrative fees and expenses for the six months ended

June 30, 2025 and 2024

, respectively.

The Company's expenses for the three and nine months ended September 30, 2025, were not material.

The Company expensed approximately $0.1 million and $0.2 million in related general and administrative fees and expenses for the three and nine months ended September 30, 2024, respectively.

Critical Accounting Policies and Significant Judgments and Estimates

There have been no material changes to our critical accounting policies and use of estimates from those disclosed in our Form 10-K for the year ended December 31, 2024.

For a discussion of our critical accounting policies and use of estimates, refer to Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Estimates in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2024.

There have been no material changes to our critical accounting policies and use of estimates from those disclosed in our Form 10-K for the year ended December 31, 2024, refer to Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Estimates in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2024.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis