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NeuroBo Pharmaceuticals Q3 2024 Financial Results and Corporate Update
15 November 2024
NeuroBo Pharmaceuticals Reports Third Quarter 2024 Financial Results and Highlights
NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology firm specializing in cardiometabolic diseases, has released its financial outcomes for the third quarter ending September 30, 2024, alongside key corporate updates. Prominent among these is the positive top-line data from the single ascending dose (SAD) Part 1 of its Phase 1 clinical trial evaluating DA-1726 for obesity treatment. This trial showcases DA-1726's safety, tolerability, and dose-linear pharmacokinetics, positioning it as a potential best-in-class treatment.
The CEO of NeuroBo, Hyung Heon Kim, emphasized the significance of the positive safety data from SAD Part 1, which has spurred further investigation into DA-1726's maximum tolerated dose. With its balanced activation of glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), DA-1726 demonstrates promise in enhancing energy expenditure and potentially offering a better tolerability profile than current GLP-1 agonists. The favorable safety results have also expedited the initiation of the multiple ascending dose (MAD) study, with top-line results expected in Q1 2025.
NeuroBo has entered into a joint research agreement with Dong-A ST and ImmunoForge to develop a long-acting, once-monthly formulation of DA-1726. Additionally, the company is planning a proof-of-concept, multicenter, randomized, double-blind, placebo-controlled Part 3 of the Phase 1 trial to assess DA-1726's efficacy and safety in obese patients, expected to commence after completing Part 2.
In addition to the DA-1726 developments, NeuroBo has also made progress with DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist. The Phase 2a clinical trial for DA-1241, targeting metabolic dysfunction-associated steatohepatitis (MASH), has reached the last patient visit milestone, with full data readout anticipated by December 2024. The trial is investigating DA-1241's efficacy both independently and in combination with sitagliptin, a DPP-4 inhibitor, to determine potential synergistic effects.
Key milestones and financial highlights from Q3 2024 include:
- November 2024: Completion of the last patient visit in the Phase 2a trial for DA-1241.
- September 2024: Positive top-line data from SAD Part 1 of the Phase 1 trial for DA-1726, involving 45 obese participants. The study revealed the drug to be safe and well-tolerated, with a dose-linear pharmacokinetic profile.
- August 2024: Enrollment completion for SAD Part 1 of the Phase 1 trial for DA-1726.
- August 2024: Joint research agreement signed with Dong-A ST and ImmunoForge for developing a long-acting DA-1726 formulation using ImmunoForge's ELP technology.
- July 2024: Exclusive out-license agreement with MThera Pharma Co., Ltd. for developing and commercializing NB-01 for painful diabetic neuropathy.
- July 2024: Engagement of Chris Fang, MD, as Advisor/Consulting Chief Medical Officer.
Financial Overview for Q3 2024:
Research and Development (R&D) expenses totaled approximately $4.5 million, up from $2.3 million in Q3 2023, attributed to increased activities for DA-1241 and DA-1726 trials. For the nine months ending September 30, 2024, R&D expenses reached approximately $17.5 million, a notable increase from $5.3 million in the same period of 2023. This rise is linked to intensified R&D efforts following the acquisition of DA-1241 and DA-1726.
General and Administrative (G&A) expenses were around $1.7 million for Q3 2024, slightly up from $1.6 million in Q3 2023. For the nine months ending September 30, 2024, G&A expenses were approximately $5.7 million, compared to $4.9 million in the same period of 2023.
Total other income was approximately $0.6 million for Q3 2024, up from $0.1 million in Q3 2023, primarily due to a $0.3 million gain from changes in the fair value of warrant liabilities and higher interest income. For the nine months ending September 30, 2024, total other income was approximately $0.8 million, down from $3.1 million in the same period of 2023.
The net loss for Q3 2024 was approximately $5.7 million, compared to $3.8 million in Q3 2023. For the nine months ending September 30, 2024, the net loss was approximately $22.4 million, up from $7.2 million in the same period of 2023.
Cash reserves stood at approximately $21.7 million as of September 30, 2024, expected to support operations into Q3 2025.
NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology firm specializing in cardiometabolic diseases, has released its financial outcomes for the third quarter ending September 30, 2024, alongside key corporate updates. Prominent among these is the positive top-line data from the single ascending dose (SAD) Part 1 of its Phase 1 clinical trial evaluating DA-1726 for obesity treatment. This trial showcases DA-1726's safety, tolerability, and dose-linear pharmacokinetics, positioning it as a potential best-in-class treatment.
The CEO of NeuroBo, Hyung Heon Kim, emphasized the significance of the positive safety data from SAD Part 1, which has spurred further investigation into DA-1726's maximum tolerated dose. With its balanced activation of glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), DA-1726 demonstrates promise in enhancing energy expenditure and potentially offering a better tolerability profile than current GLP-1 agonists. The favorable safety results have also expedited the initiation of the multiple ascending dose (MAD) study, with top-line results expected in Q1 2025.
NeuroBo has entered into a joint research agreement with Dong-A ST and ImmunoForge to develop a long-acting, once-monthly formulation of DA-1726. Additionally, the company is planning a proof-of-concept, multicenter, randomized, double-blind, placebo-controlled Part 3 of the Phase 1 trial to assess DA-1726's efficacy and safety in obese patients, expected to commence after completing Part 2.
In addition to the DA-1726 developments, NeuroBo has also made progress with DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist. The Phase 2a clinical trial for DA-1241, targeting metabolic dysfunction-associated steatohepatitis (MASH), has reached the last patient visit milestone, with full data readout anticipated by December 2024. The trial is investigating DA-1241's efficacy both independently and in combination with sitagliptin, a DPP-4 inhibitor, to determine potential synergistic effects.
Key milestones and financial highlights from Q3 2024 include:
- November 2024: Completion of the last patient visit in the Phase 2a trial for DA-1241.
- September 2024: Positive top-line data from SAD Part 1 of the Phase 1 trial for DA-1726, involving 45 obese participants. The study revealed the drug to be safe and well-tolerated, with a dose-linear pharmacokinetic profile.
- August 2024: Enrollment completion for SAD Part 1 of the Phase 1 trial for DA-1726.
- August 2024: Joint research agreement signed with Dong-A ST and ImmunoForge for developing a long-acting DA-1726 formulation using ImmunoForge's ELP technology.
- July 2024: Exclusive out-license agreement with MThera Pharma Co., Ltd. for developing and commercializing NB-01 for painful diabetic neuropathy.
- July 2024: Engagement of Chris Fang, MD, as Advisor/Consulting Chief Medical Officer.
Financial Overview for Q3 2024:
Research and Development (R&D) expenses totaled approximately $4.5 million, up from $2.3 million in Q3 2023, attributed to increased activities for DA-1241 and DA-1726 trials. For the nine months ending September 30, 2024, R&D expenses reached approximately $17.5 million, a notable increase from $5.3 million in the same period of 2023. This rise is linked to intensified R&D efforts following the acquisition of DA-1241 and DA-1726.
General and Administrative (G&A) expenses were around $1.7 million for Q3 2024, slightly up from $1.6 million in Q3 2023. For the nine months ending September 30, 2024, G&A expenses were approximately $5.7 million, compared to $4.9 million in the same period of 2023.
Total other income was approximately $0.6 million for Q3 2024, up from $0.1 million in Q3 2023, primarily due to a $0.3 million gain from changes in the fair value of warrant liabilities and higher interest income. For the nine months ending September 30, 2024, total other income was approximately $0.8 million, down from $3.1 million in the same period of 2023.
The net loss for Q3 2024 was approximately $5.7 million, compared to $3.8 million in Q3 2023. For the nine months ending September 30, 2024, the net loss was approximately $22.4 million, up from $7.2 million in the same period of 2023.
Cash reserves stood at approximately $21.7 million as of September 30, 2024, expected to support operations into Q3 2025.
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