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NeuroBo Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update Dosed First Patient in the Single Ascending Dose Part 1 of the Phase 1 Clinical Trial of DA-1726 in Obesity, With Top-Lin

Key Takeaway: NeuroBo Pharmaceuticals announced its first quarter 2024 financial results and a corporate update, highlighting the dosing of the first patient in the Phase 1 clinical trial of DA-1726 for obesity. The company expects to report top-line data from this trial in the third quarter of 2024. Additionally, it has fully enrolled Part 1 of the Phase 2a trial for DA-1241, targeting metabolic dysfunction-associated steatohepatitis (MASH), with results anticipated in the fourth quarter of 2024. However, the company's cash reserves have decreased, raising concerns about funding for ongoing trials.

Market Sentiment Analysis

POSITIVE FACTORS

  • First patient dosed in Phase 1 clinical trial of DA-1726 for obesity.
  • Anticipated top-line data from DA-1726 expected in Q3 2024.
  • Completing enrollment for Phase 2a trial of DA-1241 for MASH, indicating progress.

CONCERNS & RISKS

  • Financial results show a decrease from the last quarter with cash reserves down to $16 million.
  • Concerns around continued funding and ability to conduct clinical trials due to cash decrease.

Full Press Release Details

NeuroBo Pharmaceuticals Reports First Quarter 2024 Financial Results
and Provides Corporate Update
Dosed First Patient in the Single Ascending Dose Part 1 of the Phase 1 Clinical Trial of DA-1726 in Obesity, With Top-Line Data Readout Expected in the Third Quarter of 2024
Anticipate First Patient to be Dosed in the Multiple Ascending Dose Part 2 of the Phase 1 Clinical Trial of DA-1726 in the Third Quarter of 2024
Part 2 of the Phase 2a Trial of DA-1241 for the Treatment of MASH Underway After Enrollment of Part 1 Completed, With Data Expected in the Fourth Quarter of 2024
Cash of $16.0 Million, Expected to Fund the Company Into the Fourth Quarter of 2024
CAMBRIDGE, May 9, 2024 - NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update.
"During the first quarter and subsequently, we continued to diligently advance the clinical development of our two, next generation cardiometabolic assets, with promising therapeutic potential in the obesity and metabolic dysfunction-associated steatohepatitis (MASH) markets," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "This past month, we began dosing patients in our first-in-human, 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), in obesity. Based on pre-clinical evidence generated to date, we strongly believe that DA-1726 may offer a superior tolerability profile compared to currently available GLP-1 agonists, due to its unique ratio of GLP1R and glucagon receptors, reducing food intake while increasing energy expenditure, leading to improved patient outcomes. Looking ahead for DA-1726, we eagerly anticipate presenting new, compelling pre-clinical data at the American Diabetes Association 84th Scientific Sessions in June of this year. We anticipate reporting top-line data from the single ascending dose (SAD) Part 1 in the third quarter of this year and also expect to dose the first patient in the multiple ascending dose (MAD) Part 2 in the third quarter of this year, with the expectation for the top-line data from the MAD Part 2 in the first quarter of 2025."
Mr. Kim continued, "Additionally, just after quarter end, we fully enrolled Part 1 of the Phase 2a clinical trial for DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for treating MASH. This milestone followed closely on the heels of the Safety Review Committee (SRC) approval, allowing the study to continue without modification, an early indication of the safety of DA-1241. Part 2 of this trial, in combination with sitagliptin, a DPP4 inhibitor, continues to enroll patients. Pre-clinical safety data, reported in January, showed promising results for DA-1241 for this combination therapy. Notably, two poster presentations, with new pre-clinical evidence on DA-1241 in combination with semaglutide (Segovia ), will be presented at the EASL Congress 2024, in June. Based on both 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 and anticipate reporting top-line results in the fourth quarter of this year."
First Quarter 2024 and Subsequent Highlights
Anticipated Clinical Milestones
First Quarter Financial and Operating Results
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 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 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 our filings with the SEC. 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.
NeuroBo Pharmaceuticals, Inc.
Marshall H. Woodworth
Chief Financial Officer
Rx Communications Group
- Tables to Follow -
NeuroBo Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share amounts and par value)
(In thousands, except per share amounts)
As of
March 31, 2024 December 31, 2023
(Unaudited)
Assets
Current assets:
Cash $ 15,988 $ 22,435
Prepaid expenses and other current assets 776 77
Total current assets 16,764 22,512
Property and equipment, net 47 46
Right-of-use asset 186 202
Other assets 21 21
Total assets $ 17,018 $ 22,781
Liabilities and stockholders' equity
Current liabilities:
Accounts payable (including related party payable of $794 and $0 as of March 31, 2024 and December 31, 2023, respectively) $ 2,079 $ 821
Accrued liabilities (including related party payable of $175 and $789 as of March 31, 2024 and December 31, 2023, respectively) 3,948 4,414
Warrant liabilities 728 658
Lease liability, short-term 70 67
Total current liabilities 6,825 5,960
Lease liability, long-term 117 136
Total liabilities 6,942 6,096
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value per share; 10,000 shares authorized as of March 31, 2024 and December 31, 2023; no shares issued or outstanding as of March 31, 2024 and December 31, 2023 - -
Common stock, $0.001 par value per share, 100,000 shares authorized as of March 31, 2024 and December 31, 2023; 4,906 shares issued and outstanding as of March 31, 2024 and December 31, 2023 5 5
Additional paid-in capital 125,050 124,945
Accumulated deficit (114,979) (108,265)
Total stockholders' equity 10,076 16,685
Total liabilities and stockholders' equity $ 17,018 $ 22,781
NeuroBo Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited - In thousands, except share and per share amounts)
Three Months Ended March 31,
2024 2023
Operating expenses:
Research and development $ 4,904 $ 637
General and administrative 1,977 1,883
Total operating expenses 6,881 2,520
Loss from operations (6,881) (2,520)
Other income (expense):
Change in fair value of warrant liabilities (70) (84)
Interest income 237 -
Total other income 167 (84)
Loss before income taxes (6,714) (2,604)
Provision for income taxes - -
Net loss and comprehensive loss (6,714) (2,604)
Loss per share of common stock, basic and diluted $ (1.32) $ (0.51)
Weighted average shares of common stock, basic and diluted 5,089,408 5,059,003

Frequently Asked Questions

What is DA-1726 being developed for?

DA-1726 is being developed to treat obesity.

When will top-line data for DA-1726 be available?

Top-line data for DA-1726 is expected in Q3 2024.

What condition is DA-1241 targeting?

DA-1241 targets Metabolic Dysfunction-Associated Steatohepatitis (MASH).

When is the data readout for DA-1241's trial expected?

Data from DA-1241's trial is anticipated in Q4 2024.

How much cash does NeuroBo Pharmaceuticals have?

NeuroBo Pharmaceuticals has $16.0 million in cash.

Last updated: May 9, 2024