What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2026-08-13 compared with 2026-05-14 · 101 added, 44 removed, 156 unchanged (48% of the section changed)

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Forward-looking statements include, but are not limited to, statements about:

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;

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

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

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;

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 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 evaluating Annamycin, also known as L-Annamycin and by its generic name "naxtarubicin”, which we believe is a "next-generation” anthracycline and, with it, are conducting a pivotal Phase 3 trial in combination with cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML).

Moleculin is a late-stage pharmaceutical development company currently evaluating Annamycin, also known as L-Annamycin and by its generic name "naxtarubicin”, which we believe is a "next-generation” anthracycline and, with it, are conducting a pivotal Phase 2/3 trial in combination with cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML).

We call this the "MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation).

A blinded preliminary data readout has already been released for the MIRACLE trial, and we expect to have an interim unblinding of data in mid-2026 and an additional unblinding in the second half of 2026, thereby concluding Part A of the two-part trial.

We released interim unblinded data on June 30, 2026 for the first 45 subjects of Part A of MIRACLE where the Annamycin arms demonstrated a complete remission (CR) rate at least three times greater than the control arm’s CR rate.

The unblinding of Part A’s full 90 subjects (including the first 45 subjects already released) is expected in the December 2026 to February 2027 timeframe, thereby concluding Part A of the two-part trial.

Since results from Part A will be combined with Part B to determine the trial outcome, this means that preliminary primary endpoint results for approximately 20% of the total trial will be disclosed with the completion of Part A.

We believe such early visibility for a pivotal registration-enabling trial is unique in that stakeholders will receive preliminary safety and efficacy data long before the conclusion of the trial.

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For each of the core technologies, one or more drug candidates have successfully completed a Phase 1 or greater clinical trial.

Three of our drug candidates have shown human activity in clinical trials and are currently or have been in Phase 1B/2, Phase 2, Phase 2B/3 clinical trials.

Three of our drug candidates have shown human activity in clinical trials and are currently or have been in Phase 1B/2, Phase 2, Phase 2/3 clinical trials.

One of those drug candidates is Annamycin, which is currently in the MIRACLE trial.

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It is our lead drug candidate, and we have concluded a Phase 1B/2 clinical trial for treating AML and are now conducting a Phase 3 clinical trial for R/R AML, which we believe will be registration enabling.

We have also sponsored two Phase 1B/2 clinical trials of Annamycin for treating Soft Tissue Sarcoma metastasized to the lungs (STS lung metastases, STS lung mets, or Advanced STS), the results of which we believe supports further clinical development beyond Phase 1 and further evaluation of Annamycin’s therapeutic potential in this indication.

We have also sponsored two Phase 1B/2 clinical trials of Annamycin for treating soft tissue sarcoma metastasized to the lungs (STS lung metastases, STS lung mets, or Advanced STS), the results of which we believe support further clinical development beyond Phase 1 and further evaluation of Annamycin’s therapeutic potential in this indication.

We believe that our lead drug candidate Annamycin has:

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3) shown in preclinical models to circumvent multidrug resistance by avoiding MDR1 mechanisms and also to avoid cross-resistance with some of the most commonly used drugs for the treatment of AML (as well as many other cancers), including currently prescribed anthracyclines, cytarabine and venetoclax and, 4) exhibited in preclinical models substantially improved tissue/organ distribution;

Demonstrated a complete remission (CR) rate of 50% and a composite complete remission (CRc) rate of 60% in combination with cytarabine for the treatment of R/R AML as second line therapy (n=10).

On an all-comer’s basis (no limit on prior lines of therapy), the population of subjects who achieved a CR (n=8) demonstrated durability of approximately 13 months with median overall survival of 15 months and developing at the time of analysis, with 4 of 8 subjects (50%) censored;

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

Demonstrated positive clinical activity in our MB-106 trial with a CR rate of 50% and a composite complete remission (CRc) rate of 60% in combination with cytarabine for the treatment of R/R AML as second line therapy (n=10).

Exhibited positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the Company's pivotal Phase 2/3 MIRACLE trial, analyzed on a full intent-to-treat basis with no patient exclusions with both Annamycin treatment arms demonstrating favorable efficacy trends compared with the control arm in patients with relapsed or refractory acute myeloid leukemia (R/R AML).

The interim analysis in a difficult to treat population (increased age and prior venetoclax therapies included) demonstrated an efficacy advantage for both Annamycin treatment arms, 190 mg/m² plus HiDAC and 230 mg/m² plus HiDAC, over the HiDAC control arm.

CR reached 43% and 36% in the respective Annamycin cohorts, compared with 12% for control, while CRc reached 50% and 57%, respectively, versus 29% for the control arm;

Shown encouraging activity in a total of five different clinical trials, which are now complete with clinical study reports for internally funded trials, funded both internally and externally (through investigator-initiated trials);

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Recent Business Developments

Clinical and Regulatory Updates

On May 13, 2026, we announced that the first unblinding of data from our pivotal Phase 2B/3 “MIRACLE” trial remains on track to occur prior to June 30, 2026, as expected.

The MIRACLE trial is evaluating Annamycin in combination with cytarabine compared to cytarabine plus a placebo for the treatment of subjects that have been relapsed or refractory to their primary line of treatment for acute myeloid leukemia (R/R AML).

The trial incorporates two arms of Annamycin at different doses plus cytarabine compared to the control arm of cytarabine plus a placebo.

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

Clinical, Market Research and Scientific/Regulatory Updates

Blinded data update (n=62):

On July 31, 2026, we announced updated preliminary blinded results from Part A of our MIRACLE trial.

With 62 subjects evaluable to date in Part A, the preliminary blinded CR rate was 24% and the CRc rate was 37%.

Of those 62 subjects, 30, or 48%, had previously received a venetoclax-based regimen.

Among that subgroup, the preliminary blinded CR and CRc rates were 23% and 37%, respectively, essentially identical to the evaluable population as a whole.

Because this analysis remains blinded, it includes subjects randomized to the control arm and is therefore expected to be lower than the unblinded Annamycin-arm results reported at the June 2026 interim analysis, stated below.

The two sets of response rates – blinded data versus unblinded data - are not directly comparable.

Across three successive blinded analyses, at 30, 45 and 62 evaluable subjects, the blinded CRc has remained within a narrow band of approximately 37% to 40%, while the proportion of subjects entering the trial after failure of a first-line venetoclax-based regimen has risen from 31.1% in the n=45 population to 48% in the latest blinded data readout.

As of August 6, 2026, enrollment stands at 76 of 90 subjects, and additional subjects continue to be identified by site investigators.

The Company expects to treat the 90th subject in September 2026, with unblinding of the comprehensive Part A data anticipated in the December 2026 to February 2027 timeframe.

The trial continues with no evidence of drug-related cardiotoxicity.

Unblinded data update (n=45):

On June 30, 2026, we announced positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the Company's pivotal Phase 2/3 MIRACLE trial, analyzed on a full intent-to-treat basis with no patient exclusions.

Both Annamycin treatment arms demonstrated favorable efficacy trends compared with the control arm in patients with relapsed or refractory acute myeloid leukemia (R/R AML).

The interim analysis demonstrated a clear efficacy advantage for both Annamycin treatment arms, 190 mg/m² plus HiDAC and 230 mg/m² plus HiDAC, over the HiDAC control arm.

CR reached 43% and 36% in the respective Annamycin cohorts, compared with 12% for control, while CRc reached 50% and 57%, respectively, versus 29% for the control arm.

The n=45 population contained 75.6% over 60 years of age, 55.6% 7 days of cytarabine plus 3 days of an anthracycline (7+3) and 31.1% venetoclax regimens for first line (1L) therapies.

Importantly, the remission rates for all three arms, including the control arm, reflect outcomes measured after only a single cycle of therapy, as specified by the MIRACLE protocol.

The most commonly cited historical benchmarks in this setting, including the MIRROS and CLASSIC I studies, as well as Moleculin’s own MB-106 study, permitted multiple cycles of treatment.

The Company therefore expected absolute remission rates for both the control and Annamycin arms in this single-cycle interim analysis to be lower than those reported in such multi-cycle datasets and believes the most meaningful comparison is the performance of the Annamycin arms relative to the concurrent, randomized control arm evaluated on the same single-cycle basis.

Blinded data update (n=45):

On May 13, 2026, we reported that preliminary blinded efficacy data for the first 45 subjects treated continue to approximate previously disclosed results, including a composite complete remission rate (CRc) exceeding 40% and a complete remission (CR) rate of approximately 30%.

These results compare favorably to historical CR rates from two major independent trials of approximately 17–18% observed with cytarabine alone in similar patient populations.

Cytarabine monotherapy is considered a standard of care for second line treatment of AML.

Based on preliminary data, the median age for subjects enrolled is in the mid-60’s, with over 30% entering the trial after becoming relapsed from or refractory to a prior venetoclax regimen as first line therapy, which is considered a particularly challenging patient group.

As of May 5, 2026, 56 subjects (62% of Part A) have been recruited and randomized in the MIRACLE trial, keeping us on track to recruit the 90th subject in Part A in Q3 2026.

Recruitment Update March 2026:

On March 23, 2026, we announced that the 45th subject was enrolled in the MIRACLE trial, a milestone triggering the final phase of preparation for the trial’s highly anticipated interim 45 subject data unblinding, which remains on track for mid-2026.

Scientific Presentations of Preclinical Data

Market Research

On June 5, 2026, we announced results from an independent market landscape assessment evaluating Annamycin in relapsed/refractory acute myeloid leukemia (R/R AML).

The research demonstrated strong physician interest in Annamycin, with oncologists reporting an average likelihood-to-prescribe score of 6 out of 7.

Physicians cited Annamycin's reported complete remission rates, MRD-negative responses, potential to bridge patients to bone marrow transplant, biomarker-agnostic applicability and no evidence of cardiotoxicity as key factors supporting potential adoption.

The study included perspectives from academic and community hematologist-oncologists, medical oncologists and pediatric AML specialists.

Respondents consistently identified significant unmet need in R/R AML, particularly for patients without actionable mutations and those who relapse or progress following venetoclax-based therapy.

Separately, interviews with hospital administrators and insurers revealed that payers view Annamycin as a potentially meaningful value proposition, driven by its efficacy and safety profile and applicability to a broad patient population.

Scientific/Regulatory

Poster on Cardiac Safety of Annamycin at ASCO

On May 29, 2026, new data were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting further reinforcing the differentiated cardiac safety profile of our lead drug candidate, Annamycin (also known as “L-Annamycin” or “naxtarubicin”).

The poster presentation, titled “Cardiac safety of L-annamycin at high cumulative anthracycline exposure:

Pooled analysis,” highlighted findings from a pooled analysis across five completed clinical trials evaluating Annamycin in patients with acute myeloid leukemia (AML) and soft tissue sarcoma.

The analysis demonstrated no detectable cardiotoxicity despite cumulative exposure levels that substantially exceeded traditional lifetime anthracycline dose limitations.

The pooled analysis included 90 patients treated with Annamycin across five completed clinical trials, with source-verified paired pre- and post-treatment left ventricular ejection fraction (LVEF) assessments available for 78 patients.

Patients received a median cumulative Annamycin dose of 660 mg/m², with exposure ranging from 210 mg/m² to 2,970 mg/m² – levels that, in many cases, substantially exceeded conventional anthracycline lifetime dose thresholds.

Abstract on Cardiac Safety of Annamycin at EHA

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Mean ejection fraction remained stable, and no association was observed between cumulative dose and cardiac function decline.

Additional analyses of serial ECG's, troponins, and global longitudinal strain assessments similarly demonstrated no evidence of drug-induced cardiotoxicity.

Additional analyses of serial ECGs, troponins, and global longitudinal strain assessments similarly demonstrated no evidence of drug-induced cardiotoxicity.

Data Presented at AACR 2026 Annamycin Extends Survival in Metastatic Pancreatic Cancer Preclinical Models

On April 23, 2026, we announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting 2026 highlighting the potential of our lead drug candidate, Annamycin, in pancreatic cancer.

Access the poster here.

The data demonstrate that liposomal Annamycin (L-ANN or naxtarubicin), a novel, non-cardiotoxic anthracycline, produced significant tumor growth inhibition across multiple pancreatic ductal adenocarcinoma (PDAC) models, including orthotopic human PDAC and syngeneic systems, with strong statistical significance (p < 0.001).

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Abstract Accepted for Poster Presentation at the 2026 ASCO Annual Meeting

On April 21, 2026, we announced that an abstract highlighting data on our lead drug candidate, Annamycin, was accepted for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois.

On April 21, 2026, we announced that an abstract highlighting data on our lead drug candidate, Annamycin, was accepted for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, was held May 29 – June 2, 2026, in Chicago, Illinois.

The abstract, titled “ Cardiac safety of L-annamycin at high cumulative anthracycline exposure:

Pooled analysis, ” will be presented in a poster session focused on Symptom Science and Palliative Care.

The abstract presents a pooled analysis evaluating the cardiac safety profile of annamycin in patients with high cumulative exposure to anthracyclines, an important consideration given the known risk of cardiotoxicity associated with this class of chemotherapeutic agents.

Pooled analysis, ” was presented in a poster session focused on Symptom Science and Palliative Care.

The abstract presented a pooled analysis evaluating the cardiac safety profile of Annamycin in patients with high cumulative exposure to anthracyclines, an important consideration given the known risk of cardiotoxicity associated with this class of chemotherapeutic agents.

Other Corporate

Financing in August 2026

On August 3, 2026, we completed a public offering of (i) 12,376,667 shares of common stock, or pre-funded warrants in lieu thereof, and (ii) Series I Warrants to purchase up to 37,130,001 shares of common stock.

The combined public offering price was $0.75 per share of common stock (or pre-funded warrant in lieu thereof) and accompanying warrant.

Each pre-funded warrant is exercisable into one share of common stock at an exercise price of $0.001 per share and expires when exercised in full.

The Series I Warrants are exercisable into one share of common stock at an exercise price of $0.75 per share and expire on the five-year anniversary of the closing date.

The Series I Warrants contain anti-dilution provisions that reduce the exercise price (subject to a floor price of $0.21) in the event we issue common stock or common stock equivalents at a price below the then-current exercise price, other than in connection with certain exempt issuances.

In connection with the offering, we agreed not to issue any shares of common stock or securities convertible into common stock for 45 days after the closing date, subject to certain exceptions, and agreed not to effect any variable rate transaction for 180 days after the closing date.

We received gross proceeds of approximately $9.3 million in the offering, before deducting placement agent fees and other offering expenses.

We paid total placement agent fees and other offering expenses of approximately $0.8 million.

Due to the pricing of the offering, and certain provisions, the exercise price of our outstanding Series G warrants was adjusted to $1.326 per share, and the exercise price of our outstanding Series H warrants was adjusted to $0.962 per share.

We issued 11,088,334 common shares, and prefunded warrants for 1,288,333 shares, which were exercised shortly after the offering.

Closing Australian Subsidiary

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The invention is jointly owned with The University of Texas System.

Business transactions

In May 2026, we sold 354,757 shares under the 2025 ATM Agreement for net proceeds of approximately $0.8 million where the lowest price sold was $2.01 per share which reset the Series G and H warrants from $2.40 to $2.01 per share.

In May 2026, we entered into a consulting agreement to provide clinical services pursuant to which it issued the consultant a five-year warrant to purchase 100,000 shares of common stock at an exercise price of $2.48 per shares vesting in twelve equal installments over a one-year period.

Other Corporate

These warrants were reset subsequent to the period to $1.326 and $0.962, respectively.

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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Other income (loss):

Gain from change in fair value of warrant liability

Gain (loss) from change in fair value of warrant liability

Transaction costs allocated to warrant liabilities

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Other income, net

Interest income, net

Three Months Ended March 31, 2026 Compared to Three Months Ended March 31, 2025

Interest income (expense), net

Three Months Ended June 30, 2026 Compared to Three Months Ended June 30, 2025

Research and Development Expense.

Research and development (R&D) expense was $5.4 million and $3.4 million for the three months ended March 31, 2026 and 2025 , respectively.

The increase of $2.0 million is mainly related to the MIRACLE clinical trials in Europe of $1.4 million and additional nonclinical studies of $0.3 million plus other research costs during the current quarter as compared to the prior year quarter.

Gain from Change in Fair Value of Warrant Liability.

We recorded a net gain of $10.8 million in the first quarter of 2026 due to the change in fair value of the Series H warrant liability after the February 2026 inducement.

Research and development (R&D) expense was $5.5 million and $3.6 million for the three months ended June 30, 2026 and 2025 , respectively.

The increase of $1.9 million is mainly related to the MIRACLE clinical trials of $1.1 million, additional nonclinical studies of $0.4 million, and $0.4 million in other research costs during the current quarter as compared to the prior year quarter.

Loss from Change in Fair Value of Warrant Liability.

We recorded a net loss of $7 thousand in the second quarter of 2026 as compared to a net loss of $560 thousand in the second quarter of 2025, 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.

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.

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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.

There were no offerings during the second quarter of 2026, therefore, there was no loss as compared to $10.4 million loss for the prior quarterly period in 2025.

Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025

Research and Development Expense.

Research and development (R&D) expense was $10.8 million and $7.0 million for the six months ended June 30, 2026 and 2025 , respectively.

The increase of $3.8 million is primarily related to the MIRACLE clinical trials of $2.7 million, additional nonclinical studies of $0.7 million and other research costs of $0.4 million during the six months ended June 30, 2026 as compared to the six months ended June 30, 2025.

Gain (loss) from Change in Fair Value of Warrant Liability.

We recorded a net gain of $10.8 million in the six months ended June 30, 2026 as compared to a net loss of $0.6 million in the six months ended June 30, 2025, 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.

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.

Transaction costs on the Series H warrants in February 2026 amounted to $0.7 million.

The loss on issuance of the warrant liabilities for the Series H warrants was $15.2 million as compared to no loss for the prior quarterly period in 2025.

The loss on issuance of the warrant liabilities for the Series H warrants was $15.2 million as compared to a $10.4 million loss for the prior six month period in 2025.

Liquidity and Capital Resources

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

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Effect of exchange rate changes on cash and cash equivalents

Net increase in cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Cash used in operating activities

Cash used in operations was $6.1 million for the three months ended March 31, 2026 .

Cash used in operations was $12.8 million for the six months ended June 30, 2026 .

This $2.7 million increase over the prior year period of $10.1 million was primarily due to the timing of costs incurred and associated payments for clinical trial expenses and drug production and other testing related expenses.

Cash provided by fin ancing activities

During June of 2026, warrants were exercised for the issuance of 1,396,500 shares at $2.01 per share for proceeds of approximately $2.8 million.

In May 2026, we sold 354,757 shares under the 2025 ATM Agreement for net proceeds of approximately $0.8 million where the lowest price sold was $2.01 per share.

On February 19, 2026, we entered into warrant inducement agreements with certain holders of our existing equity-classified Series E and Series F warrants.

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In consideration for such exercises, we issued new Series H warrants to purchase up to 6,367,956 shares of common stock.

The Series H warrants have a five-year term and an exercise price of $2.3976 per share.

The Series H warrants have a five-year term and an initial exercise price of $2.3976 per share.

The warrants contain customary anti-dilution adjustments and beneficial ownership limitations and became exercisable upon stockholder approval in April 2026.

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In addition, the exercise price of our outstanding Series F warrants was adjusted to $2.75 per share, and the exercise price of our outstanding Series G warrants was adjusted to $2.3976 per share.

We recorded a deemed dividend of $1.8 million resulting from the downward adjustment to the exercise price of certain warrants and the increase in the number of shares underlying certain outstanding warrants, in each case triggered by the anti-dilution provisions contained in the original warrant agreements.

The deemed dividend was recorded within additional paid-in capital and recognized as a reduction to income available to common stockholders.

In connection with the August 2026 offering, the exercise price of the outstanding Series G warrants was further adjusted to $1.326 per share, and the exercise price of the outstanding Series H warrants was adjusted to $0.962 per share.

On December 23, 2025, we increased the maximum aggregate gross sales price of our common stock that may be offered, issued and sold under our at the market equity offering agreement (the “2025 ATM Agreement”) with Roth Capital Partners, LLC (“Roth”), which we initially entered into in July 2025, from $6.5 million to $8.2 million.

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During the first quarter of 2026, we sold 3,785 shares of common stock pursuant to the 2025 ATM Agreement for gross proceeds of approximately $18,000.

We believe that our cash on hand and cash equivalents as of March 31, 2026, plus the $0.8 million raised subsequent to the quarter via issuance of common stock under its ATM, is sufficient to fund our planned operations into the third quarter of 2026.

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

We believe that our cash on hand and cash equivalents as of June 30, 2026, plus the $9.3 million gross proceeds raised subsequent to the quarter as described above, are sufficient to fund our planned operations into the first quarter of 2027.

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 funds of approximately $25 million, to support MIRACLE and our operations into the first quarter of 2027 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 must seek additional funds of approximately $8 million, to support MIRACLE and our operations into the second quarter of 2027 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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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