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Moleculin Reports Full Year 2024 Financial Results and Provides Corporate Update

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Moleculin Biotech (NASDAQ: MBRX) has reported its financial results for fiscal year 2024 and provided updates on its MIRACLE trial progress. The company is advancing its pivotal Phase 3 clinical trial for Annamycin in combination with Cytarabine for treating relapsed or refractory Acute Myeloid Leukemia (R/R AML).

Key developments include:

  • First subject treatment expected in Q1 2025
  • Initial data readout from 45 subjects anticipated in H2 2025
  • Multiple subjects currently being screened at first MIRACLE site
  • Received positive FDA guidance leading to smaller trial size
  • Secured first European country approval for trial enrollment

Financial highlights for 2024:

  • R&D expenses decreased to $17.7M from $19.5M in 2023
  • G&A expenses reduced to $8.8M from $10.0M in 2023
  • Cash position of $4.3M as of December 31, 2024
  • Additional $9.3M raised in February 2025
The company expects current funding to support operations into Q3 2025.

Moleculin Biotech (NASDAQ: MBRX) ha riportato i risultati finanziari per l'anno fiscale 2024 e fornito aggiornamenti sui progressi del trial MIRACLE. L'azienda sta avanzando con il suo trial clinico di fase 3 cruciale per Annamycin in combinazione con Cytarabine per il trattamento della leucemia mieloide acuta recidivante o refrattaria (R/R AML).

Sviluppi chiave includono:

  • Il trattamento del primo soggetto è previsto nel primo trimestre del 2025
  • La lettura dei dati iniziali da 45 soggetti è attesa nel secondo semestre del 2025
  • Numerosi soggetti sono attualmente in fase di screening presso il primo sito MIRACLE
  • Ricevuta guida positiva dalla FDA che ha portato a una dimensione del trial ridotta
  • Ottenuta l'approvazione del primo paese europeo per l'arruolamento nel trial

Risultati finanziari per il 2024:

  • Le spese per R&S sono diminuite a $17.7M rispetto a $19.5M nel 2023
  • Le spese generali e amministrative sono state ridotte a $8.8M rispetto a $10.0M nel 2023
  • Posizione di liquidità di $4.3M al 31 dicembre 2024
  • Ulteriori $9.3M raccolti a febbraio 2025
L'azienda prevede che il finanziamento attuale sosterrà le operazioni fino al terzo trimestre del 2025.

Moleculin Biotech (NASDAQ: MBRX) ha reportado sus resultados financieros para el año fiscal 2024 y ha proporcionado actualizaciones sobre el progreso de su ensayo MIRACLE. La compañía está avanzando con su ensayo clínico pivotal de fase 3 para Annamycin en combinación con Cytarabine para tratar la leucemia mieloide aguda en recaída o refractaria (R/R AML).

Desarrollos clave incluyen:

  • Se espera el tratamiento del primer sujeto en el primer trimestre de 2025
  • Se anticipa la lectura de datos iniciales de 45 sujetos en la segunda mitad de 2025
  • Varios sujetos están siendo evaluados actualmente en el primer sitio MIRACLE
  • Recibida orientación positiva de la FDA que ha llevado a un tamaño de ensayo más pequeño
  • Aprobación del primer país europeo para la inscripción en el ensayo

Aspectos financieros destacados para 2024:

  • Los gastos de I+D disminuyeron a $17.7M desde $19.5M en 2023
  • Los gastos generales y administrativos se redujeron a $8.8M desde $10.0M en 2023
  • Posición de efectivo de $4.3M al 31 de diciembre de 2024
  • Se recaudaron $9.3M adicionales en febrero de 2025
La compañía espera que el financiamiento actual respalde las operaciones hasta el tercer trimestre de 2025.

몰레큘린 바이오텍 (NASDAQ: MBRX)는 2024 회계연도의 재무 결과를 보고하고 MIRACLE 시험 진행 상황에 대한 업데이트를 제공했습니다. 이 회사는 재발성 또는 불응성 급성 골수성 백혈병(R/R AML) 치료를 위해 Cytarabine과 함께 Annamycin의 중요한 3상 임상 시험을 진행하고 있습니다.

주요 개발 사항은 다음과 같습니다:

  • 첫 번째 피험자 치료는 2025년 1분기에 예상됨
  • 45명의 피험자로부터의 초기 데이터는 2025년 하반기에 예상됨
  • 첫 번째 MIRACLE 사이트에서 여러 피험자가 현재 선별 중
  • 작은 시험 규모로 이어지는 긍정적인 FDA 가이드라인 수령
  • 시험 등록을 위한 첫 번째 유럽 국가 승인 확보

2024년 재무 하이라이트:

  • R&D 비용이 2023년 1950만 달러에서 1770만 달러로 감소
  • 일반 및 관리 비용이 2023년 1000만 달러에서 880만 달러로 감소
  • 2024년 12월 31일 기준 현금 보유액 430만 달러
  • 2025년 2월에 930만 달러 추가 조달
회사는 현재 자금이 2025년 3분기까지 운영을 지원할 것으로 예상하고 있습니다.

Moleculin Biotech (NASDAQ: MBRX) a publié ses résultats financiers pour l'année fiscale 2024 et a fourni des mises à jour sur l'avancement de son essai MIRACLE. L'entreprise fait progresser son essai clinique pivot de phase 3 pour l'Annamycin en combinaison avec le Cytarabine pour traiter la leucémie myéloïde aiguë récurrente ou réfractaire (R/R AML).

Les développements clés incluent:

  • Le traitement du premier sujet est prévu au premier trimestre 2025
  • Les premières données de 45 sujets sont attendues au second semestre 2025
  • Plusieurs sujets sont actuellement en cours de sélection au premier site MIRACLE
  • Obtention d'orientations positives de la FDA menant à une taille d'essai réduite
  • Obtention de l'approbation du premier pays européen pour l'inscription à l'essai

Points financiers pour 2024:

  • Les dépenses de R&D ont diminué à 17,7 millions de dollars contre 19,5 millions de dollars en 2023
  • Les dépenses générales et administratives ont été réduites à 8,8 millions de dollars contre 10,0 millions de dollars en 2023
  • Position de liquidités de 4,3 millions de dollars au 31 décembre 2024
  • 9,3 millions de dollars supplémentaires levés en février 2025
L'entreprise s'attend à ce que le financement actuel soutienne les opérations jusqu'au troisième trimestre 2025.

Moleculin Biotech (NASDAQ: MBRX) hat seine finanziellen Ergebnisse für das Geschäftsjahr 2024 veröffentlicht und Updates zum Fortschritt der MIRACLE-Studie bereitgestellt. Das Unternehmen führt seine entscheidende Phase-3-Studie für Annamycin in Kombination mit Cytarabine zur Behandlung von rezidivierter oder refraktärer akuter myeloischer Leukämie (R/R AML) voran.

Wichtige Entwicklungen umfassen:

  • Die Behandlung des ersten Probanden wird im ersten Quartal 2025 erwartet
  • Die ersten Daten von 45 Probanden werden für das zweite Halbjahr 2025 erwartet
  • Mehrere Probanden werden derzeit am ersten MIRACLE-Standort gescreent
  • Positive FDA-Richtlinien erhalten, die zu einer kleineren Studiengröße geführt haben
  • Erste Genehmigung eines europäischen Landes für die Studienanmeldung erhalten

Finanzielle Highlights für 2024:

  • F&E-Ausgaben sind von 19,5 Millionen USD im Jahr 2023 auf 17,7 Millionen USD gesunken
  • Allgemeine und Verwaltungskosten sind von 10,0 Millionen USD im Jahr 2023 auf 8,8 Millionen USD gesenkt worden
  • Bargeldbestand von 4,3 Millionen USD zum 31. Dezember 2024
  • Zusätzliche 9,3 Millionen USD im Februar 2025 gesammelt
Das Unternehmen erwartet, dass die aktuellen Mittel die Operationen bis ins dritte Quartal 2025 unterstützen werden.

Positive
  • FDA guidance led to smaller trial size, potentially accelerating development timeline
  • Secured first European country approval for MIRACLE trial enrollment
  • Reduced R&D and G&A expenses by $3M compared to 2023
  • Successfully raised $9.3M in February 2025 financing
  • New preclinical findings showed significant activity in Venetoclax resistant AML model
Negative
  • Cash runway only extends into Q3 2025, suggesting potential need for additional financing
  • First patient treatment delayed to Q1 2025
  • Complete trial results not expected until 2028

Insights

Moleculin's financial results and clinical progress show a company making strides toward key milestones while managing financial constraints. The Phase 3 MIRACLE trial for Annamycin in R/R AML features an adaptive design with planned early unblinding at 45 subjects in H2 2025, potentially providing a critical catalyst. The FDA-recommended trial optimization allowing for fewer subjects should accelerate development and reduce costs.

The company's regulatory achievements, including Fast Track Status and Orphan Drug Designation from both FDA and EMA, provide validation for their approach and potential expedited pathways. The adaptive trial design with dose optimization (190 mg/m² vs 230 mg/m²) demonstrates thoughtful regulatory engagement.

However, the financial picture creates uncertainty. With $4.3 million cash at year-end plus $9.3 million from February financing providing runway only into Q3 2025, the company faces a concerning timeline mismatch with their H2 2025 data readout. This virtually guarantees additional financing before key catalysts materialize.

The decreased R&D ($17.7 million vs $19.5 million) and G&A expenses ($8.8 million vs $10.0 million) reflect cost discipline but may constrain development resources. For a company with a $14 million market cap running a global Phase 3 program, the financial runway relative to upcoming milestones creates significant investment uncertainty despite promising clinical progress.

– Continued progress in pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) toward first subject treated, on track to take place in the first quarter of 2025

– Multiple subjects currently being screened in first MIRACLE site activated

– Initial data readout of the Phase 3 MIRACLE trial expected in the second half of 2025

– Company to host conference call and webcast today, Monday, March 24th at 8:30 AM ET

HOUSTON, March 24, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today reported its financial results for the fiscal year ended December 31, 2024. As previously announced, the Company will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, March 24, 2025 (details below).

“This last year proved to be a very productive and substantial year for Moleculin. We believe that we continue to successfully execute on activities for our MIRACLE trial, supported by a growing body of positive preliminary data and encouraging interactions with FDA and clinical sites,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “Looking ahead, we look forward to an exciting year with a number of potential value-driving milestones expected in the coming months. Importantly, with the clinical and regulatory progress made to date, we still expect to unblind preliminary data from the first 45 subjects in the second half of this year. Our team is dedicated to advancing the development of Annamycin and we look forward to providing additional updates.”

Recent Highlights

  • Expanded global exclusivity for Annamycin with Notice of Intent to Grant for the European patent application titled, “Method of Reconstituting Liposomal Annamycin“;
  • Received positive FDA guidance for acceleration of its registration-enabling MIRACLE trial for R/R Acute Myeloid Leukemia (AML) resulting in a smaller number of subjects in MIRACLE;
  • Received first country regulatory approval in Europe to begin enrolling for the MIRACLE trial;
  • Received US Institutional Review Board (IRB) approval for pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) and engaged a leading contract research organization (CRO); and,
  • Announced new preclinical findings demonstrating significant activity of Annamycin in Venetoclax resistant AML model.

Clinical Development Update

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

The Company is currently evaluating Annamycin in combination with Cytarabine (also known as “Ara-C” and for which the combination of Annamycin and Ara-C is referred to as “AnnAraC”) in a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be global, including sites in the US, Europe and the Middle East.

The MIRACLE study is a Phase 2B/3 clinical trial whereby data from the 2B portion will be combined with the Phase 3 portion. MIRACLE is subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, utilizes an adaptive design whereby the first 75 to 90 subjects will be randomized (1:1:1) in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, which Annamycin doses were specifically recommended by the FDA in the Company’s end of Phase 1B/2 meeting. The amended protocol allows for the unblinding of preliminary primary efficacy data (Complete Remission or CR) and safety/tolerability of the three arms at 45 subjects, in addition to the conclusion of Part A (at 75 to 90 subjects). The first early unblinding will yield 30 subjects with Annamycin (190mg/m2 and 230/m2) and HiDAC and 15 subjects with just HiDAC. The Company expects to reach the first unblinding (45 subjects) in the second half of 2025, in addition to the second unblinding, which is expected in the first half of 2026. This accelerated estimated timeline is due to the positive response the Company received in meetings during December with potential investigators regarding recruitment for the trial.

Early activities include: Multiple first subjects in Ukraine are being screened and we expect to begin treatment by the end of March; Corresponding ethic committee approvals were received recently in Georgia and Egypt with the appropriate regulatory approvals remaining; and, multiple site evaluation and initiation visits are occurring and/or being scheduled.

For Part B of the trial, approximately 220 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin (randomized 1:1). The selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA’s new Project Optimus initiative. For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756.

Expected Milestones for Annamycin AML Development Program

  • 1Q – 3Q 2025 – Update on MIRACLE trial site selection/approvals by countries
  • 1Q 2025 – First subject enrolled and treated in MIRACLE trial
  • 2025 – Recruitment update for MIRACLE trial
  • 2H 2025 – Data readout (n=45) unblinded efficacy/safety review
  • 2H 2025 – 2026 – Impact of data readout (n=45) on regulatory pathway; Recruitment update
  • 1H 2026 – Interim efficacy and safety data (n=~75-90) unblinded and Optimum Dose set for MIRACLE trial
  • 2027 – Begin enrollment of 3rd line subjects in MIRACLE2
  • 2027 – Enrollment ends in 2nd line subjects
  • 2028 – Primary efficacy data for 2nd line subjects in MIRACLE
  • 2028 – Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE
  • 2028 – Primary efficacy data for 2nd line subjects
  • 2028 – Rolling NDA submission begins

Soft Tissue Sarcoma (STS) Lung Metastases

As previously announced, the Company completed enrollment in the Phase 2 portion of its U.S. Phase 1B/2 clinical trial evaluating Annamycin as monotherapy for the treatment of soft tissue sarcoma lung metastases. Subjects who had stable disease at the time of study discontinuation were followed for progression free response and overall survival. The clinical study report is finalized but not yet filed and is expected to be released by the end of April 2025.

Expected Milestones for Annamycin STS Lung Mets Development Program

  • 1H 2025 – Final MB-107 data readout
  • 2025 – Identify next phase of development / pivotal IIT (investigator-initiated-trial) program

Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA).

Summary of Financial Results for the Full Year 2024

Research and development (R&D) expense was $17.7 million and $19.5 million for the years ended December 31, 2024 and 2023, respectively. The decrease in R&D of $1.8 million is mainly related to the $1.5 million WPD sublicense termination in 2023, which enabled the reacquisition of our intellectual property rights in certain territories, including parts of the European Union.

General and administrative (G&A) expenses were $8.8 million and $10.0 million for the years ended December 31, 2024 and 2023, respectively. The decrease in G&A of $1.2 million was mainly attributable to a decrease in regulatory and legal services, and consulting & advisory fees. 

As of December 31, 2024, the Company had cash and cash equivalents of $4.3 million. The Company believes that the existing cash and cash equivalents as of December 31, 2024, along with $9.3 million in gross proceeds received as part of the February 2025 financing activities will be sufficient to fund our planned operations into the third quarter of 2025.

Conference Call and Webcast

Moleculin management will host its quarterly conference call and webcast for investors, analysts, and other interested parties on Monday, March 24, 2024 at 8:30 AM ET.

Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live audio webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

The Company is initiating the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the achievements of each of the milestones in this press release. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com

Moleculin Biotech, Inc.    
Unaudited Condensed Consolidated Balance Sheets   
(in thousands) December 31, 2024 December 31, 2023
Current assets:    
Cash and cash equivalents $4,278  $23,550 
Prepaid expenses and other current assets  916   2,723 
     Total current assets  5,194   26,273 
Furniture and equipment, net  159   272 
Intangible assets  11,148   11,148 
Operating lease right-of-use asset  424   524 
     Total assets $16,925  $38,217 
     
Current liabilities:    
Accounts payable and accrued expenses and other current liabilities $5,359  $6,815 
     Total current liabilities  5,359   6,815 
Operating lease liability - long-term, net of current portion  358   474 
Warrant liability - long term  5,229   4,855 
     Total liabilities  10,946   12,144 
Total stockholders' equity  5,979   26,073 
     Total liabilities and stockholders' equity $16,925  $38,217 
     
Unaudited Condensed Consolidated Statements of Operations    
  Year Ended December 31,
(in thousands, except share and per share amounts)  2024   2023 
Revenues $-  $- 
Operating expenses:    
Research and development  17,729   19,487 
General and administrative and depreciation and amortization  8,912   10,144 
     Total operating expenses  26,641   29,631 
Loss from operations  (26,641)  (29,631)
Other income:    
Gain (loss) from change in fair value of warrant liability  6,125   (1,044)
Transaction costs allocated to warrant liabilities  (993)  (510)
Loss on issuance of warrant liabilities  (847)  - 
Other income, net  43   48 
Interest income, net  550   1,368 
Net loss  (21,763)  (29,769)
     
Net loss per common share - basic and diluted $(6.32) $(15.07)
Weighted average common shares outstanding - basic and diluted  3,442,997   1,975,610 

FAQ

When will Moleculin (MBRX) release initial data from the MIRACLE Phase 3 trial?

Moleculin expects to release the first unblinded data from 45 subjects in the second half of 2025.

How much cash does MBRX have and how long will it last?

MBRX has $4.3M in cash as of December 2024, plus $9.3M raised in February 2025, expected to fund operations into Q3 2025.

What are the key milestones for MBRX's MIRACLE trial in 2025?

Key 2025 milestones include first subject treatment in Q1, ongoing site approvals, recruitment updates, and initial data readout of 45 subjects in H2.

How did MBRX's R&D and G&A expenses change in 2024?

R&D expenses decreased by $1.8M to $17.7M, and G&A expenses decreased by $1.2M to $8.8M compared to 2023.

What regulatory designations does MBRX's Annamycin have?

Annamycin has FDA Fast Track Status and Orphan Drug Designation for R/R AML and soft tissue sarcoma, plus EMA Orphan Drug Designation for R/R AML.
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