Moleculin Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Moleculin Biotech reported its Q3 2024 financial results and provided a corporate update. Key highlights include the initiation of dosing in the Phase 3 MIRACLE trial for Annamycin in Q1 2025. The median durability of CRc in the MB-106 trial has exceeded 8 months. Moleculin hosted a virtual AML KOL event and appointed Dr. Daniel D. Von Hoff to its Scientific Advisory Board.
Financially, R&D expenses rose to $4.9 million from $3.3 million year-over-year, while G&A expenses decreased to $2.2 million from $2.6 million. The company closed a $5.5 million financing and has $9.4 million in cash reserves, expected to fund operations into Q1 2025.
Upcoming milestones include the first subject treated in the MIRACLE trial in Q1 2025 and final data readout for the STS lung metastases trial in 2025. Moleculin will host a conference call on November 11, 2024, at 8:30 AM ET to discuss these updates.
Moleculin Biotech ha riportato i risultati finanziari del terzo trimestre 2024 e fornito un aggiornamento aziendale. I principali punti salienti includono l'inizio della somministrazione nel trial di Fase 3 MIRACLE per Annamycin nel primo trimestre del 2025. La durata mediana della risposta completa confermata (CRc) nel trial MB-106 ha superato gli 8 mesi. Moleculin ha ospitato un evento virtuale con esperti nel campo della leucemia mieloide acuta (AML) e ha nominato il Dr. Daniel D. Von Hoff nel suo Consiglio Consultivo Scientifico.
Dal punto di vista finanziario, le spese di ricerca e sviluppo sono aumentate a 4,9 milioni di dollari rispetto ai 3,3 milioni dell'anno precedente, mentre le spese generali e amministrative sono diminuite a 2,2 milioni di dollari rispetto ai 2,6 milioni. L'azienda ha chiuso un finanziamento di 5,5 milioni di dollari e dispone di 9,4 milioni di dollari in riserve di cassa, che si prevede copriranno le operazioni fino al primo trimestre del 2025.
I prossimi traguardi includono il primo soggetto trattato nel trial MIRACLE nel primo trimestre del 2025 e la lettura finale dei dati per il trial su metastasi polmonari STS nel 2025. Moleculin ospiterà una conferenza telefonica l'11 novembre 2024, alle 8:30 AM ET, per discutere di questi aggiornamenti.
Moleculin Biotech informó sobre sus resultados financieros del tercer trimestre de 2024 y proporcionó una actualización corporativa. Los puntos clave incluyen el inicio de la dosificación en el ensayo de Fase 3 MIRACLE para Annamycin en el primer trimestre de 2025. La duración media de la respuesta completa confirmada (CRc) en el ensayo MB-106 ha superado los 8 meses. Moleculin organizó un evento virtual con líderes de opinión clave (KOL) sobre leucemia mieloide aguda (AML) y nombró al Dr. Daniel D. Von Hoff en su Consejo Asesor Científico.
Financieramente, los gastos de I+D aumentaron a 4,9 millones de dólares desde 3,3 millones del año anterior, mientras que los gastos generales y administrativos disminuyeron a 2,2 millones desde 2,6 millones. La compañía cerró un financiamiento de 5,5 millones de dólares y tiene 9,4 millones de dólares en reservas de efectivo, que se espera financien las operaciones hasta el primer trimestre de 2025.
Los próximos hitos incluyen el primer sujeto tratado en el ensayo MIRACLE en el primer trimestre de 2025 y la lectura final de datos para el ensayo de metástasis pulmonares STS en 2025. Moleculin llevará a cabo una conferencia telefónica el 11 de noviembre de 2024, a las 8:30 AM ET, para discutir estas actualizaciones.
Moleculin Biotech는 2024년 3분기 재무 결과를 보고하고 기업 업데이트를 제공했습니다. 주요 하이라이트에는 2025년 1분기에 Annamycin에 대한 3상 MIRACLE 시험에서 투여를 시작한 것이 포함됩니다. MB-106 시험에서의 CRc(완전 관해 지속 시간) 중앙값이 8개월을 초과했습니다. Moleculin은 AML(급성 골수성 백혈병) 관련 가상 KOL 이벤트를 개최했으며, Dr. Daniel D. Von Hoff를 과학 자문 위원회에 임명했습니다.
재무적으로, 연구 및 개발 비용은 작년 대비 3.3 백만 달러에서 4.9 백만 달러로 증가했으며, 일반 관리 비용은 2.6 백만 달러에서 2.2 백만 달러로 감소했습니다. 회사는 5.5 백만 달러의 자금을 확보했으며, 2025년 1분기까지 운영 자금을 지원할 것으로 예상되는 9.4 백만 달러의 현금 잔고를 보유하고 있습니다.
앞으로의 이정표에는 2025년 1분기에 MIRACLE 시험에서 처음으로 치료받는 대상이 포함되며, 2025년 STS 폐 전이 시험의 최종 데이터 결과가 포함됩니다. Moleculin은 2024년 11월 11일 오전 8시 30분 ET에 이 업데이트를 논의하기 위한 전화 회의를 개최할 것입니다.
Moleculin Biotech a publié ses résultats financiers du troisième trimestre 2024 et a fourni une mise à jour sur l'entreprise. Les points clés incluent le démarrage de l'administration dans l'essai de Phase 3 MIRACLE pour l'Annamycin au premier trimestre 2025. La durée médiane de la réponse complète confirmée (CRc) dans l'essai MB-106 a dépassé 8 mois. Moleculin a organisé un événement virtuel avec des leaders d'opinion sur la leucémie myéloïde aiguë (AML) et a nommé le Dr Daniel D. Von Hoff à son Conseil consultatif scientifique.
Sur le plan financier, les dépenses en R&D sont passées de 3,3 millions de dollars à 4,9 millions de dollars d'une année sur l'autre, tandis que les dépenses générales et administratives ont diminué de 2,6 millions à 2,2 millions. L'entreprise a clôturé un financement de 5,5 millions de dollars et possède 9,4 millions de dollars en réserves de liquidités, ce qui devrait financer ses opérations jusqu'au premier trimestre 2025.
Les prochaines étapes incluent le premier sujet traité dans l'essai MIRACLE au premier trimestre 2025 et la lecture finale des données pour l'essai sur les métastases pulmonaires STS en 2025. Moleculin organisera une conférence téléphonique le 11 novembre 2024 à 8h30 ET pour discuter de ces mises à jour.
Moleculin Biotech hat seine Finanzberichte für das dritte Quartal 2024 veröffentlicht und ein Unternehmens-Update bereitgestellt. Zu den wichtigsten Highlights gehört der Beginn der Dosierung in der Phase-3-Studie MIRACLE für Annamycin im ersten Quartal 2025. Die mediane Dauer des „Complete Response Confirmed“ (CRc) in der MB-106-Studie hat 8 Monate überschritten. Moleculin veranstaltete ein virtuelles AML KOL-Event und ernannte Dr. Daniel D. Von Hoff in seinen wissenschaftlichen Beirat.
Finanziell sind die F&E-Ausgaben von 3,3 Millionen Dollar auf 4,9 Millionen Dollar im Jahresvergleich gestiegen, während die allgemeinen und administrativen Ausgaben von 2,6 Millionen Dollar auf 2,2 Millionen Dollar gesenkt wurden. Das Unternehmen hat eine Finanzierung in Höhe von 5,5 Millionen Dollar abgeschlossen und verfügt über 9,4 Millionen Dollar an Barmitteln, die voraussichtlich die Operationen bis ins erste Quartal 2025 unterstützen werden.
Zu den bevorstehenden Meilensteinen gehört der erste behandelte Proband in der MIRACLE-Studie im ersten Quartal 2025 und die endgültige Datenauswertung für die STS-Lungenmetastasen-Studie im Jahr 2025. Moleculin wird am 11. November 2024 um 8:30 Uhr ET eine Telefonkonferenz abhalten, um diese Updates zu besprechen.
- Initiation of Phase 3 MIRACLE trial for Annamycin in Q1 2025.
- Median CRc durability in MB-106 trial exceeds 8 months.
- Closed $5.5 million financing with potential for an additional $11 million.
- Decreased G&A expenses from $2.6 million to $2.2 million.
- Increased R&D expenses from $3.3 million to $4.9 million.
- Cash reserves of $9.4 million only sufficient to fund operations into Q1 2025.
Insights
The Q3 2024 results reveal significant operational progress but concerning financial metrics. R&D expenses increased by
The pivotal MIRACLE trial for Annamycin in AML treatment represents a major catalyst, with patient dosing expected in Q1 2025. However, the extensive trial design requiring 315-330 subjects suggests substantial future funding requirements. The recent
While clinical progress is promising, investors should monitor cash burn rate and potential dilution risks. The company's market cap of
The MIRACLE trial design shows strategic positioning for potential accelerated approval pathway. The adaptive two-stage approach with dose optimization aligns with FDA's Project Optimus initiative, potentially streamlining the development process. The 8+ month durability of complete response composite (CRc) in the MB-106 trial is particularly noteworthy, as durability of response is important for AML treatments.
The dual development programs in AML and STS lung metastases provide multiple shots on goal. The locked database for the STS trial and pending clinical study report in early 2025 could offer near-term validation of Annamycin's efficacy profile. The addition of Dr. Von Hoff to the Scientific Advisory Board adds credibility to the pancreatic cancer program expansion potential.
- On track to start dosing in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML in Q1 2025
- Median durability of CRc in MB-106 Annamycin+ Cytarabine AML clinical trial continues to climb - now past 8 months
- Recent virtual AML KOL event underscores how Annamycin could significantly change the AML treatment landscape; Replay available here
- Company to host conference call and webcast today, Monday, November 11th at 8:30 AM ET
"We are thrilled to have emerged as a late stage company. Our focus remains on the ramp up for and execution of our upcoming MIRACLE trial. We have been extremely active and our recent interactions with potential clinical trial sites globally have been overwhelmingly positive as we prepare for the start of enrollment and dosing early next year. We believe with our recent clinical and regulatory 'wins,' we have foundationally set the stage for a transformational year ahead and the opportunity to drive significant value for all stakeholders. With that said, we continue to follow our CRc (complete response composite) preliminary data from our MB-106 Phase 1B/2 AML clinical trial. We are also pleased with the median durability continuing to climb – and is now in excess of 8 months," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.
Recent Highlights
- Appointed Daniel D. Von Hoff, M.D., F.A.C.P., FASCO, FAACR, leading expert in Pancreatic Cancer to its Scientific Advisory Board to Support Development of Annamycin;
- Hosted a Virtual Acute Myeloid Leukemia KOL event with internationally renowned Acute Myeloid Leukemia (AML) Key Opinion Leaders to discuss Annamycin, the use of anthracyclines, how Annamycin could significantly change the AML treatment landscape, and the Company's recently announced global Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (the "MIRACLE" trial);
- Presented positive in vivo efficacy data of Annamycin in orthotopic and experimental lung metastatic models of Sarcoma in a poster titled "Annamycin: Opening New Doors for Organotropic Targeting of Primary and Metastatic Lung Cancer," at the IASLC 2024 World Conference on Lung Cancer;
- Commenced enrollment and treatment of patients in the Investigator-initiated Phase 2 study evaluating WP1066 in combination with radiation therapy for the treatment of adults with glioblastoma; and
- Closed a
$5.5 million $11.0 million
Clinical Development Update
Annamycin is currently being evaluated in ongoing clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. 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).
AML
The Company recently announced the positive discussion and outcome of its End of Phase 1B/2 (EOP1B/2) meeting with the US Food and Drug Administration (FDA) supporting the advancement of 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") to 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 a global trial, including sites in the US.
The MIRACLE study, subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, is expected to initially utilize an adaptive design whereby approximately the first 75 to 90 subjects will be randomized to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin. At that point, the trial will be unblinded to select the optimum dose for Annamycin. For the second part of the trial, approximately 240 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin. The selection of the optimum dose will be based not only on the overall balance of safety, tolerability, pharmacokinetics and efficacy, consistent with the FDA's new Project Optimus initiative.
Expected Milestones for Annamycin AML Development Program
- 4Q 2024 – Contracting with MIRACLE trial sites and IRB approval
- 1Q 2025 – First subject treated in MIRACLE trial
- 4Q 2025 – Recruitment and overall efficacy rate update (n=45)
- 2H 2026 – Interim efficacy and safety data (n=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 2H – 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
STS Lung Metastases
As previously announced, the Company completed enrollment in the Phase 2 portion of its
Expected Milestones for Annamycin STS Lung Mets Development Program
- 2025 – Final MB-107 data readout
- 2025 – Identify next phase of development / pivotal program
Summary of Financial Results for the Third Quarter 2024
Research and development (R&D) expense was
General and administrative expense was
As of September 30, 2024, the Company had cash and cash equivalents of
Conference Call and Webcast
Moleculin management will host its quarterly conference call and webcast for investors, analysts, and other interested parties on Monday, November 11, 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 Company's forecasted cash burn rate (including its estimate of cash sufficient to meet its projected operating requirements) and the achievement of the expected milestones set forth above. 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) | September 30, 2024 | December 31, 2023 | ||||||
Current assets: | ||||||||
Cash and cash equivalents | $ 9,405 | $ 23,550 | ||||||
Prepaid expenses and other current assets | 2,201 | 2,723 | ||||||
Total current assets | 11,606 | 26,273 | ||||||
Furniture and equipment, net | 190 | 272 | ||||||
Intangible assets | 11,148 | 11,148 | ||||||
Operating lease right-of-use asset | 450 | 524 | ||||||
Total assets | $ 23,394 | $ 38,217 | ||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses and other current liabilities | $ 5,593 | $ 6,815 | ||||||
Total current liabilities | 5,593 | 6,815 | ||||||
Operating lease liability - long-term, net of current portion | 390 | 474 | ||||||
Warrant liability - long term | 9,932 | 4,855 | ||||||
Total liabilities | 15,915 | 12,144 | ||||||
Total stockholders' equity | 7,479 | 26,073 | ||||||
Total liabilities and stockholders' equity | $ 23,394 | $ 38,217 | ||||||
Unaudited Condensed Consolidated Statements of Operations | ||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||
(in thousands, except share and per share amounts) | 2024 | 2023 | 2024 | 2023 | ||||
Revenues | $ - | $ - | $ - | $ - | ||||
Operating expenses: | ||||||||
Research and development | 4,932 | 3,280 | 13,274 | 12,855 | ||||
General and administrative and depreciation and amortization | 2,203 | 2,667 | 6,724 | 7,857 | ||||
Total operating expenses | 7,135 | 5,947 | 19,998 | 20,712 | ||||
Loss from operations | (7,135) | (5,947) | (19,998) | (20,712) | ||||
Other income: | ||||||||
(Loss) gain from change in fair value of warrant liability | (1,728) | 1 | 1,423 | 76 | ||||
Transaction costs allocated to warrant liabilities | (993) | - | (993) | - | ||||
Loss on issuance of warrant liabilities | (847) | - | (847) | - | ||||
Other income, net | 9 | 13 | 31 | 30 | ||||
Interest income, net | 102 | 324 | 503 | 1,106 | ||||
Net loss | (10,592) | (5,609) | (19,881) | (19,500) | ||||
Net loss per common share - basic and diluted | $ (2.85) | $ (2.82) | $ (6.83) | $ (9.94) | ||||
Weighted average common shares outstanding - basic and diluted | 3,714,278 | 1,987,283 | 2,910,842 | 1,961,327 | ||||
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SOURCE Moleculin Biotech, Inc.
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