NeuroBo Pharmaceuticals, Inc. - NRBO STOCK NEWS

NeuroBo Pharmaceuticals (NRBO) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

• Completed a $70 million financing, with $20 million upfront and $50 million in milestone-based warrants
• $27.9 million cash at quarter-end, expected to fund operations into Q2 2025
• Fully enrolled SAD Part 1 of DA-1726 Phase 1 trial for obesity, with top-line data expected in Q3 2024
• Entered joint research agreement to develop long-acting formulation of DA-1726
• Part 2 of DA-1241 Phase 2a trial for MASH underway, top-line data expected in Q4 2024
• Net loss of $10.1 million for Q2 2024, compared to $0.7 million in Q2 2023

The company is advancing its cardiometabolic pipeline with multiple upcoming milestones for DA-1726 and DA-1241.

NeuroBo Pharmaceuticals (Nasdaq: NRBO) has completed enrollment for Part 1 of its Phase 1 clinical trial evaluating DA-1726, a novel dual oxyntomodulin analog agonist for obesity treatment. The single ascending dose (SAD) study enrolled 45 participants across 5 cohorts. No significant issues were encountered, allowing an accelerated start to the multiple ascending dose (MAD) Part 2.

Key points:

• Top-line data from SAD Part 1 expected in Q3 2024
• MAD Part 2 results anticipated in Q1 2025
• Pre-clinical data showed superior weight loss compared to semaglutide and tirzepatide
• DA-1726 may become a best-in-class obesity drug with better tolerability
• Part 3 of the trial planned to start in Q3 2025, with interim data expected mid-2026 and top-line results in H2 2026

NeuroBo Pharmaceuticals (Nasdaq: NRBO) has entered a joint research agreement with Dong-A ST and ImmunoForge to develop a long-acting, once-monthly formulation of DA-1726 for obesity treatment. DA-1726 is a novel, dual oxyntomodulin analog agonist functioning as a GLP1R and GCGR agonist, currently in Phase 1 studies. The collaboration will utilize ImmunoForge's Elastin-Like Polypeptide (ELP) platform technology, which can potentially increase a drug's half-life by up to 200 times.

This agreement aims to enhance patient compliance and ease of administration for obesity treatment. The ELP technology could overcome limitations in creating longer-acting forms of peptides like DA-1726. The collaboration seeks to develop what could be a first-in-class, once-monthly obesity treatment. Financial terms of the agreement were not disclosed.

NeuroBo Pharmaceuticals (Nasdaq: NRBO) has signed an exclusive license agreement with MThera Pharma for NB-01, a potential treatment for painful diabetic neuropathy. The agreement grants MThera rights to conduct research and clinical trials, including a possible Phase 3 trial in the US and South Korea. This move aligns with NeuroBo's strategy to out-license legacy assets and focus on developing DA-1726 and DA-1241.

MThera, with its expertise in natural medicines and botanical drugs, plans to utilize its SyMthomics platform to identify NB-01's mechanism of action and active ingredients. This approach aims to predict clinical efficacy and advance NB-01 into further clinical development, building on its positive Phase 2 results for diabetic neuropathy.

NeuroBo Pharmaceuticals (Nasdaq: NRBO), a clinical-stage biotech company, will present at the Emerging Growth Conference on July 18, 2024, at 10:50 am ET. Hyung Heon Kim, President and CEO, along with Marshall H. Woodworth, CFO, will provide an overview of the company's work. The focus will be on DA-1726, a novel dual OXM agonist targeting GLP1R and GCGR receptors for obesity treatment. The session will include a Q&A segment, with questions to be submitted in advance or during the event. Register online to attend and receive updates. For additional meetings, contact Michael Miller.

NeuroBo Pharmaceuticals (Nasdaq: NRBO) has dosed the first patient in Part 2 of its Phase 1 clinical trial of DA-1726, a dual oxyntomodulin analog agonist for obesity treatment. This MAD study, expected to enroll 36 participants, will investigate safety, tolerability, and pharmacokinetics, with top-line data anticipated in Q1 2025. Part 3 of the trial, assessing weight loss and dietary changes over 24 weeks, will begin in Q3 2025, with interim data expected mid-2026. A recent $70 million financing will support the clinical development. Pre-clinical models showed DA-1726's superior weight loss compared to other drugs. The trial aims to establish DA-1726 as a best-in-class obesity treatment.

NeuroBo Pharmaceuticals has closed a private placement and a registered direct offering priced at-the-market under Nasdaq rules, securing approximately $20 million upfront. The company issued 4,325,701 shares of common stock at $3.93 per share in the private placement and 763,359 shares in the direct offering.

The total gross proceeds could reach up to $70 million, contingent on the full exercise of Series Warrants linked to clinical milestones. The funds will support working capital, general corporate purposes, and the clinical development of DA-1726 for obesity treatment.

H.C. Wainwright & Co. served as the exclusive placement agent for the offerings.

NeuroBo Pharmaceuticals (Nasdaq: NRBO) has announced two concurrent financial events: a private placement and a registered direct offering, both priced at-the-market under Nasdaq rules. The company aims to secure $20 million initially, with potential additional gross proceeds of up to $50 million through the exercise of Series Warrants. The funds will support the Phase 1 Part 3 clinical trial for DA-1726, targeting obesity treatment.

The private placement involves selling 4,325,701 shares at $3.93 per share, while the direct offering includes 763,359 shares at the same price. Unregistered Series A and B warrants will be issued for the purchase of up to 12,722,651 shares in total, with varying expiration conditions based on clinical milestones.

The closing is expected around June 25, 2024, pending customary conditions. H.C. Wainwright & Co. is the exclusive placement agent. The proceeds will be used for working capital, general corporate purposes, and continued clinical development of DA-1726.

NeuroBo Pharmaceuticals revealed pre-clinical data for DA-1726, a new dual oxyntomodulin analog agonist, showing superior weight loss, lean body mass retention, and lipid-lowering effects compared to survodutide. In obese mouse models, DA-1726 significantly outperformed survodutide in reducing cholesterol (T-CHO: -67.7% vs. -49.6%) and triglycerides (TG: -49.5% vs. -41.2%). DA-1726 also demonstrated better glucose-lowering effects (-54.7% vs. -30.4% of survodutide). The drug's efficacy was tested at the ADA 84th Scientific Sessions in Orlando, June 21-24, 2024. The Phase 1 trial is ongoing, with initial dosing in Q3 and top-line data expected in Q1 2025.