NeuroBo Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Corporate Update
NeuroBo Pharmaceuticals reported Q3 2024 financial results and clinical progress. The company announced positive top-line data from the SAD Part 1 Phase 1 trial of DA-1726 for obesity treatment, showing favorable safety and dose-linear pharmacokinetics. With $21.7 million cash on hand, operations are funded into Q3 2025. Key upcoming milestones include top-line results from DA-1241's Phase 2a MASH trial in December 2024 and DA-1726's MAD Part 2 data in Q1 2025. Q3 net loss was $5.7 million, with R&D expenses increasing to $4.5 million compared to $2.3 million in Q3 2023.
NeuroBo Pharmaceuticals ha riportato i risultati finanziari del terzo trimestre del 2024 e i progressi clinici. L'azienda ha annunciato dati positivi di alto livello dalla fase 1 del trial SAD Part 1 di DA-1726 per il trattamento dell'obesità, mostrando una sicurezza favorevole e una pharmacocinetica dose-lineare. Con 21,7 milioni di dollari in cassa, le operazioni sono finanziate fino al terzo trimestre del 2025. Tra i principali traguardi futuri ci sono i risultati di alto livello dal trial MASH di fase 2a di DA-1241 a dicembre 2024 e i dati della parte MAD 2 di DA-1726 nel primo trimestre del 2025. La perdita netta del terzo trimestre è stata di 5,7 milioni di dollari, con le spese per R&S che sono aumentate a 4,5 milioni di dollari rispetto ai 2,3 milioni di dollari del terzo trimestre del 2023.
NeuroBo Pharmaceuticals presentó los resultados financieros del tercer trimestre de 2024 y los avances clínicos. La compañía anunció datan positivos de alto nivel del ensayo SAD Parte 1 de la fase 1 de DA-1726 para el tratamiento de la obesidad, mostrando una seguridad favorable y una farmacocinética lineal por dosis. Con 21.7 millones de dólares en efectivo, las operaciones están financiadas hasta el tercer trimestre de 2025. Los hitos clave que se acercan incluyen resultados de alto nivel del ensayo MASH de fase 2a de DA-1241 en diciembre de 2024 y los datos de la parte MAD 2 de DA-1726 en el primer trimestre de 2025. La pérdida neta del tercer trimestre fue de 5.7 millones de dólares, con los gastos en I+D aumentados a 4.5 millones de dólares en comparación con 2.3 millones de dólares en el tercer trimestre de 2023.
NeuroBo Pharmaceuticals는 2024년 3분기 재무 결과 및 임상 진행 상황을 보고하였습니다. 회사는 비만 치료를 위한 DA-1726의 SAD 1부 1상 시험에서 긍정적인 주요 데이터를 발표했으며, 유리한 안전성과 용량 선형 약리학적 특성을 보여주었습니다. 2170만 달러의 현금을 보유한 회사는 2025년 3분기까지 운영 자금을 확보하고 있습니다. 주요 향후 이정표로는 2024년 12월에 있을 DA-1241의 2a상 MASH 시험의 주요 결과와 2025년 1분기에 있을 DA-1726의 MAD 2부 데이터가 포함됩니다. 3분기 순손실은 570만 달러였으며, R&D 비용은 3분기 2023년의 230만 달러에서 450만 달러로 증가했습니다.
NeuroBo Pharmaceuticals a communiqué les résultats financiers du troisième trimestre 2024 et les progrès cliniques. La société a annoncé des données positives de haut niveau de l'essai SAD Partie 1 de la phase 1 de DA-1726 pour le traitement de l'obésité, montrant une sécurité favorable et une pharmacocinétique linéaire en fonction de la dose. Avec 21,7 millions de dollars de liquidités disponibles, les opérations sont financées jusqu'au troisième trimestre 2025. Les grandes étapes à venir comprennent les résultats de haut niveau de l'essai MASH de phase 2a de DA-1241 en décembre 2024 et les données de la partie MAD 2 de DA-1726 au premier trimestre 2025. La perte nette du troisième trimestre s'élève à 5,7 millions de dollars, avec des dépenses de R&D en hausse à 4,5 millions de dollars par rapport à 2,3 millions de dollars au troisième trimestre 2023.
NeuroBo Pharmaceuticals hat die finanziellen Ergebnisse für das dritte Quartal 2024 und den klinischen Fortschritt berichtet. Das Unternehmen gab positive Hochdaten aus der SAD Teil 1 Phase 1 Studie zu DA-1726 zur Behandlung von Fettleibigkeit bekannt, die eine günstige Sicherheit und eine dosenlineare Pharmakokinetik zeigen. Mit 21,7 Millionen Dollar an liquiden Mitteln sind die Betriebe bis ins dritte Quartal 2025 finanziert. Zu den wichtigen kommenden Meilensteinen gehören die Hochdaten der Phase 2a MASH Studie von DA-1241 im Dezember 2024 sowie die MAD Teil 2 Daten von DA-1726 im ersten Quartal 2025. Der Nettoverlust im dritten Quartal betrug 5,7 Millionen Dollar, wobei die F&E-Ausgaben auf 4,5 Millionen Dollar im Vergleich zu 2,3 Millionen Dollar im dritten Quartal 2023 gestiegen sind.
- Positive top-line safety and tolerability data from DA-1726 Phase 1 trial
- Strong cash position of $21.7M funding operations through Q3 2025
- Signed exclusive out-license agreement for NB-01 with MTHERA
- Established joint research agreement for long-acting DA-1726 formulation
- Net loss increased to $5.7M in Q3 2024 from $3.8M in Q3 2023
- R&D expenses doubled to $4.5M from $2.3M year-over-year
- G&A expenses increased to $1.7M from $1.6M year-over-year
Insights
Analysis of NeuroBo's Q3 2024 results reveals significant developments in their clinical pipeline alongside concerning financial metrics. R&D expenses increased substantially to
The net loss widened to
The clinical progress for DA-1726 shows promise in the competitive obesity treatment landscape. The positive SAD Part 1 results demonstrating favorable safety profile and dose-linear pharmacokinetics are encouraging early indicators. The development of a potential once-monthly formulation through the joint research agreement could provide a significant competitive advantage in the GLP-1 market.
The upcoming Q4 2024 milestones, including DA-1241's Phase 2a results in MASH and DA-1726's MAD data, represent critical validation points. The dual mechanism of DA-1726 targeting both GLP1R and GCGR receptors could potentially offer improved efficacy compared to existing treatments, though this remains to be proven in later-stage trials.
Reported Positive Top-Line Data From the SAD Part 1 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity, Revealing Favorable Safety, Tolerability and Dose-Linear Pharmacokinetics
Top-Line Results from the Phase 2a Trial of DA-1241 for the Treatment of MASH Expected in December of 2024
Top-Line Data From the MAD Part 2 of the Phase 1 Trial of DA-1726 Expected in the First Quarter of 2025
Entered into a Joint Research Agreement, Together With Dong-A ST and ImmunoForge to Develop a Long-Acting Once-Monthly Formulation of DA-1726
"The third quarter was punctuated by the positive top-line results from the single ascending dose (SAD) Part 1 of our Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity, revealing it to be safe and tolerable as well as demonstrating dose-linear pharmacokinetics (PK)," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "Based on the excellent safety data from the SAD Part 1, we are currently engaged in the addition of one or more cohorts to further investigate the maximum tolerated dose, enabling us to fully harness the potential of DA-1726. Based on the pre-clinical data available, along with DA-1726's balanced activation of GLP1R and glucagon receptors, which enhances energy expenditure, we maintain our belief that it can emerge as a best-in-class obesity treatment, offering a more favorable tolerability profile compared to existing GLP-1 agonists and those in late-stage clinical trials. Importantly, the drug's strong safety profile also enabled the accelerated initiation of the multiple ascending dose (MAD) study, for which we expect to report top-line results from the planned cohorts during the first quarter of 2025.
"To further differentiate DA-1726, early in the quarter, we signed a joint research agreement, together with our collaboration partner, Dong-A ST and ImmunoForge, to develop a long-acting once monthly formulation of the drug. Additionally, we continue to plan for an early proof-of-concept, multicenter, randomized, double-blind, placebo-controlled Part 3 of the Phase 1 clinical trial to evaluate the efficacy and safety of DA-1726 in obese, otherwise healthy subjects, reflecting our strong commitment to rapidly advancing the clinical development of this promising cardiometabolic asset. Part 3 is anticipated to begin upon the completion of Part 2."
Mr. Kim continued, "After recently announcing the last patient last visit in our Phase 2a clinical trial for DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in subjects with presumed metabolic dysfunction-associated steatohepatitis (MASH), our next clinical milestone is the full data readout expected in December of this year. As a reminder, the trial is exploring the efficacy of DA-1241 independently, as well as in combination with sitagliptin, a DPP-4 inhibitor, which we believe will show synergistic effects compared to DA-1241, alone. Based on pre-clinical and clinical evidence generated to date, we continue to believe that DA-1241 has the potential to be a safe and effective treatment for MASH."
Third Quarter 2024 and Subsequent Highlights
- November 2024: Completed the last patient last visit in its two-part, Phase 2a clinical trial evaluating the efficacy and safety of DA-1241 for the treatment of MASH.
- September 2024: Announced positive top-line safety, tolerability and dose-linear PK data from the SAD Part 1 of its Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity. A total of 45 obese, otherwise healthy participants were randomized in a double-blind, 6:3 ratio of DA-1726 or placebo. Single ascending doses were found to be safe and well tolerated, with no serious adverse events. Only 5 subjects in the DA-1726 treatment group reported adverse events compared with 3 subjects in the placebo group. A dose-linear PK profile was observed across the investigated dose range. Additional cohorts are being added to the SAD Part 1 to explore the maximum tolerated dose.
- August 2024: Completed enrollment in the SAD Part 1 of the Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity.
- August 2024: Signed a joint research agreement, along with Dong-A ST and ImmunoForge, to develop a long-acting, once-monthly, formulation of DA-1726 utilizing ImmunoForge's long-lasting half-life extension Elastin-Like Polypeptide (ELP) platform technology.
- July 2024: Signed an exclusive out-license agreement, providing MThera Pharma Co., Ltd. (MTHERA) with the rights to develop and commercialize NB-01, one of the Company's four legacy assets, for the treatment of painful diabetic neuropathy, allowing MTHERA to conduct research and clinical trials, including, but not limited to, a potential Phase 3 clinical trial in
the United States andSouth Korea , for the future commercialization of NB-01. - July 2024: Engaged veteran biotech and pharmaceutical professional, Chris Fang, MD, as Advisor/Consulting Chief Medical Officer, effective July, 2, 2024.
Anticipated Clinical Milestones
- DA-1726 in Obesity: The last patient visit in the multiple ascending dose (MAD) study Part 2 is expected in the fourth quarter of 2024 and top-line data is expected in the first quarter of 2025. The planned Phase 1 Part 3 will evaluate early proof of concept, with the first patient expected to be enrolled during the third quarter of 2025, followed by an interim data readout in or around mid-2026 and top-line results are expected in the second half of 2026.
- DA-1241 in MASH: Top-line results from the two-part Phase 2a clinical trial of DA-1241 in MASH are expected to be available in December of 2024.
Third Quarter Financial and Operating Results
- Research and Development (R&D) Expenses were approximately
$4.5 million $2.3 million $2.2 million $2.2 million $1.9 million $0.3 million $0.7 million $0.4 million
R&D expenses were approximately$17.5 million $5.3 million $12.2 million $12.2 million $11.2 million $1.0 million $4.3 million $2.2 million - General and Administrative (G&A) Expenses were approximately
$1.7 million $1.6 million $0.1 million $0.2 million $0.1 million
G&A expenses were approximately$5.7 million $4.9 million $0.8 million $0.9 million $0.1 million - Total Other Income was approximately
$0.6 million $0.1 million $0.5 million $0.3 million $0.1 million $0.1 million
Total other income was approximately$0.8 million $3.1 million $2.3 million $2.8 million $0.5 million - Net Loss for the three months ended September 30, 2024, was approximately
$5.7 million $0.55 $3.8 million $0.75
Net loss for the nine months ended September 30, 2024, was approximately$22.4 million $3.24 $7.2 million $1.41 - Cash was approximately
$21.7 million $22.4 million
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The Company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control.
For more information, please visit www.neurobopharma.com.
Forward Looking Statements
Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects," "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contacts:
NeuroBo Pharmaceuticals, Inc.
Marshall H. Woodworth
Chief Financial Officer
+1-857-299-1033
marshall.woodworth@neurobopharma.com
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
- Tables to Follow -
NeuroBo Pharmaceuticals, Inc. | ||||||
Condensed Consolidated Balance Sheets | ||||||
(In thousands, except per share amounts) | ||||||
As of | ||||||
September 30, 2024 | December 31, 2023 | |||||
(Unaudited) | ||||||
Assets | ||||||
Current assets: | ||||||
Cash | $ | 21,669 | $ | 22,435 | ||
Prepaid expenses and other current assets | 266 | 77 | ||||
Total current assets | 21,935 | 22,512 | ||||
Property and equipment, net | 39 | 46 | ||||
Right-of-use asset | 151 | 202 | ||||
Other assets | 21 | 21 | ||||
Total assets | $ | 22,146 | $ | 22,781 | ||
Liabilities and stockholders' equity | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 1,017 | $ | 821 | ||
Clinical trial accrued liabilities | 3,354 | 3,033 | ||||
Accrued expenses and other current liabilities | 654 | 592 | ||||
Warrant liabilities | 564 | 658 | ||||
Related party payable | 3,450 | 789 | ||||
Lease liability, short-term | 75 | 67 | ||||
Total current liabilities | 9,114 | 5,960 | ||||
Lease liability, long-term | 79 | 136 | ||||
Total liabilities | 9,193 | 6,096 | ||||
Commitments and contingencies | ||||||
Stockholders' equity | ||||||
Preferred stock, | — | — | ||||
Common stock, | 9 | 5 | ||||
Additional paid–in capital | 143,628 | 124,945 | ||||
Accumulated deficit | (130,684) | (108,265) | ||||
Total stockholders' equity | 12,953 | 16,685 | ||||
Total liabilities and stockholders' equity | $ | 22,146 | $ | 22,781 | ||
NeuroBo Pharmaceuticals, Inc. | ||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||
(Unaudited - In thousands, except share and per share amounts) | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
September 30, | September 30, | |||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||
Operating expenses: | ||||||||||||
Research and development | $ | 4,517 | $ | 2,292 | $ | 17,495 | $ | 5,293 | ||||
General and administrative | 1,742 | 1,601 | 5,729 | 4,926 | ||||||||
Total operating expenses | 6,259 | 3,893 | 23,224 | 10,219 | ||||||||
Loss from operations | (6,259) | (3,893) | (23,224) | (10,219) | ||||||||
Other income (expense): | ||||||||||||
Change in fair value of warrant liabilities | 297 | (87) | 94 | 2,901 | ||||||||
Interest income | 310 | 162 | 711 | 162 | ||||||||
Total other income | 607 | 75 | 805 | 3,063 | ||||||||
Loss before income taxes | (5,652) | (3,818) | (22,419) | (7,156) | ||||||||
Provision for income taxes | — | — | — | — | ||||||||
Net loss and comprehensive net loss | (5,652) | (3,818) | (22,419) | (7,156) | ||||||||
Loss per share of common stock, basic and diluted | $ | (0.55) | $ | (0.75) | $ | (3.24) | $ | (1.41) | ||||
Weighted average shares of common stock, basic and diluted | 10,214,087 | 5,075,817 | 6,922,338 | 5,064,670 | ||||||||
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SOURCE NeuroBo Pharmaceuticals, Inc.
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