What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-08-12 compared with 2025-05-13 · 110 added, 42 removed, 201 unchanged (43% of the section changed)

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Our ability to continue our relationship with the University of Texas MD Anderson Cancer Center (MD Anderson), including, but not limited to, our ability to maintain current licenses and license future intellectual property resulting from our sponsored research agreements with MD Anderson;

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

Our ability to satisfy any requirements imposed by the US Food & Drug Administration (FDA) (or its foreign equivalents) as a condition of our clinical trials proceeding or beginning as planned;

World-wide events including the wars in Ukraine and in the Middle East, the COVID-19 pandemic, and the general supply chain shortages effects on our clinical trials, clinical drug candidate supplies, preclinical activities and our ability to raise future financing;

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

Our ability to satisfy any requirements imposed by the United States (US) Food & Drug Administration (FDA) (or its foreign equivalents) as a condition of our clinical trials proceeding or beginning as planned;

World-wide events including geopolitical conflicts, public health emergencies, and global supply chain disruptions that may affect our clinical trials, clinical drug candidate supplies, preclinical activities and our ability to raise future financing;

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

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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 Moleculin R/R AML AnnAraC Clinical Evaluation) within one year of dosing the first subject.

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.

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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 trials is currently underway.

One Phase 2B/3 trial is currently underway.

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

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Cardiac health biomarkers such as blood Troponin levels are considered an indicator of potential long-term heart damage.

The Expert issued periodic reports during our MB-106 clinical trial and will also issue updated reports after each unblinding in the Phase 2B portions of the MIRACLE trial.

The Expert issued periodic reports during our MB-106 clinical trial and will also issue updated reports over the course of the MIRACLE trial.

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.

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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 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).

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.

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 GBM at Northwestern University that is actively recruiting.

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.

MIRACLE Trial

We have a Phase 3 pivotal trial for the treatment of AML patients who are R/R after induction therapy with Annamycin in combination with Cytarabine.

We have a Phase 3 pivotal trial for the treatment, with Annamycin in combination with Cytarabine, of AML patients who are R/R after induction therapy.

This Phase 3 “MIRACLE” trial is a global study.

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Clinical and Regulatory

As of April 30, 2025, we have selected 38 sites to conduct the MIRACLE trial in the US, Europe and the Middle East/Africa (MENA) for the MIRACLE trial with one site in Ukraine actively treating subjects.

Besides the one site in Ukraine, we have contracted with two other sites in Georgia and Romania.

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.

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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Then in February 2025 we received FDA feedback and guidance on that amendment.

Such feedback allowed a reduction in the size of our Part B of the Phase 3 pivotal trial protocol to 222.

Such feedback allowed a reduction in the size of our Part B of the Phase 3 pivotal trial protocol to 222 subjects.

Guidance from FDA included a recommendation to alter the statistical plan that reduced the initially proposed size of Part B of our trial by approximately 10%.

Moreover, the nature of the feedback helps us move forward quickly to open sites in the US, in addition to the non-US sites we are expecting to open.

Any reduction in recruitment helps to shorten the time to completion of the trial.

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.

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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.

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

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).

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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.

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.

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.

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.

The FDA response calls for including patients from 6 months of age and older, with no minimum number of patients between 6 months and 2 years old.

FDA also clarified that drug concentration exposure and safety profile that are comparable would allow extrapolation from efficacy in adults.

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.

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

We plan on hosting a Key Opinion Leader (KOL) call announcing and reviewing the final top line data from the MB-107 trial in May or early June.

Originally scheduled for April, we had to delay due to KOL schedules and availability.

We remain positive regarding the data.

We recently hosted a Key Opinion Leader (KOL) call announcing and reviewing the final top line data from the MB-107 trial.

The MB-107 trial involved Annamycin monotherapy treatment for STS Lung Mets.

The final top line results of MB-107 demonstrated median overall survival (OS) of 13.5 months for subjects as median 7th line therapy (n=36).

This compares to OS of 8-12 months in standard of care treatments and 13.4 months for experimental treatments for advanced STS as 2nd line (Comandone A, et al;

“Salvage Therapy in Advanced Adult Soft Tissue Sarcoma:

A Systematic Review and Meta-Analysis of Randomized Trials”;

The Oncologist 2017;22:1518–1527).

Scientific Presentations of Preclinical Data

Promising Preclinical Data of Annamycin in Liver Cancer Treatment Presented at a Symposium at MD Anderson

On August 6, 2025, we announced the presentation of encouraging preclinical data for its lead drug candidate, Annamycin which demonstrated significant efficacy against various primary and metastatic liver cancers, including hepatocellular carcinoma (HCC), colorectal liver metastases, and pancreatic ductal adenocarcinoma (PDAC) liver metastases.

This is believed to be the result of targeted accumulation in the liver and other organs.

These findings were highlighted in a poster titled "Liposomal Annamycin (L-ANN) Efficacy Against Primary and Metastatic Liver Cancers," presented by Dr.

Waldemar Priebe, Lead Author and Chairman of the Scientific Advisory Board at Moleculin at the recently held Shelby-Lavine Pancreatic Cancer Symposium at MD Anderson Cancer Center.

AACR Presentation of Pre-Clinical Data for Annamycin Market Expansion Potential, including Pancreatic Cancer

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Clinical Trial with WP1066 at Northwestern University

With our WP1066 oral formula, an externally funded Phase 1B/2 trial in combination with radiation treating glioblastoma (GBM), a form of brain cancer, is recruiting and treating subjects at Northwestern University (Northwestern).

With our WP1066 oral formula, an externally funded Phase 1B/2 trial in combination with radiation treating GBM, a form of brain cancer, is recruiting and treating subjects at Northwestern University (Northwestern).

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

To date Northwestern has recruited and treated 7 subjects.

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

No data has been released.

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

Intellectual Property, Licenses and Sponsored Research

Other Corporate

Additional Patent for Annamycin in the EU

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.

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

On May 5, 2025, we announced that the U.S.

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

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

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Moleculin has additional patent applications related to Annamycin pending in the U.S., 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 “.

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

Such grant will enhance the global exclusivity of Annamycin with the potential to be a next generation, non-cardiotoxic treatment for certain cancers.

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.

Licenses and Sponsored Research with MD Anderson

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

1 WHO Drug Information, Vol.

Results of Operations

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Condensed Consolidated Statements of Operations

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Operating expenses:

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Interest income, net

Three Months Ended March 31, 2025 Compared to Three Months Ended March 31, 2024

1 WHO Drug Information, Vol.

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

Research and Development Expense.

Research and development (R&D) expense was $3.4 million and $4.3 million for the three months ended March 31, 2025 and 2024 , respectively.

The decrease of $0.9 million is mainly related t o the clinical trials activity levels.

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.

General and Administrative Expense.

General and administrative e xpense was $2.5 million and $2.4 million for the three months ended March 31, 2025 and 2024 , respectively.

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

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.

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.

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

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.

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.

Gain from Change in Fair Value of Warrant Liability.

We recorded a net gain of $9.1 million in the first quarter of 2025 as compared to a net gain of $1.5 million in the first 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 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.

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

The full proceeds of the February 2025 offerings were recorded to warrant liabilities, with an initial liability of $19.0 million, and a loss on initial recognition of $7.8 million.

Transaction costs related to the offering were correspondingly fully allocated to warrant liabilities, and $1.8 million in related transaction costs were expensed during the three months ended March 31, 2025.

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.

Interest income, net.

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

Three Months Ended March 31,

Six Months Ended June 30,

Net cash used in operating activities

Net cash provided by financing activities

Net cash used in investing activities

Net cash provided by (used in) financing activities

Effect of exchange rate changes on cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

As of March 31, 2025, there w as $0.6 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 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.

Cash used in operating activities

Cash used in operations was $4.6 million for the three months ended March 31, 2025 .

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 provided by fin ancing activities

On February 25, 2025, the Company 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.

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.

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.

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.

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.

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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.

The Company received gross proceeds of $3.5 million.

On February 13, 2025, the Company 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 the Company's agreement to issue the inducement warrants to purchase up to 11,657,140 shares of the Company's common stock.

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.

The Company received gross proceeds of $5.8 million.

We received gross proceeds of $5.8 million.

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

On August 19, 2024, we announced the closing of our previously announced 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.

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 March 31, 2025, is sufficient to fund our planned operations into the third quarter of 2025.

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.

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

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

March 31, 2025 and 2024

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.

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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