NeuroBo Pharmaceuticals Reports Year End 2023 Financial Results and Provides Corporate Update
- Received IRB approval for Phase 1 trial of DA-1726 in Obesity and SRC approval for Phase 2a trial of DA-1241 for MASH
- Positive pre-clinical safety data for DA-1241 and expected data from Phase 2a trial in the second half of 2024
- Cash position of $22.4 million as of December 31, 2023, expected to fund operations into the fourth quarter of 2024
- None.
Insights
The financial results of NeuroBo Pharmaceuticals highlight a strategic shift in resource allocation, with a marked increase in R&D expenses from $2.8 million to $9.2 million year-over-year. This signifies a heavy investment in the clinical development of DA-1241 and DA-1726, which targets MASH and obesity, respectively. The decrease in General and Administrative Expenses by $1.9 million suggests a cost-optimization strategy, possibly to offset the increased R&D outlay. Investors should note the company's cash runway extending into Q4 2024, which is important for continuity in their clinical trials without immediate additional funding needs.
NeuroBo's operational focus on advancing DA-1241 and DA-1726 positions the company in the high-potential markets of MASH and obesity treatment. The SRC's nod to continue the Phase 2a trial of DA-1241 without modification is a positive signal for the drug's safety profile. Moreover, the comparison of DA-1726's preclinical efficacy to established drugs like semaglutide and tirzepatide could stir market interest. However, the true impact on the stock will hinge on the actual clinical trial results expected in H2 2024 for DA-1241 and in 2025 for DA-1726. The biotech sector is highly sensitive to such milestones and positive outcomes could lead to significant valuation changes.
The progression of DA-1241 and DA-1726 into later-stage clinical trials is a testament to NeuroBo's commitment to addressing cardiometabolic diseases. The SRC's recommendation to proceed with the Phase 2a trial of DA-1241 is an encouraging development. However, the true efficacy and safety will only be determined upon the completion of the trial and subsequent data analysis. The initiation of the Phase 1 trial for DA-1726 in obesity is noteworthy, especially given the preclinical promise shown against semaglutide and tirzepatide. The challenge for NeuroBo will be to translate these preclinical results into clinical success, which is not always guaranteed given the complexity of human pathophysiology compared to preclinical models.
Received First Site Institutional Review Board (IRB) Approval to Proceed With the Phase 1 Trial of DA-1726 in Obesity
Phase 1 Trial of DA-1726 Expected to Dose First Patient in Second Quarter of 2024
Received Safety Review Committee (SRC) Approval Recommending That the Two-Part Phase 2a Trial of DA-1241 for the Treatment of MASH Continue Without Modification
Data from the Phase 2a Trial of DA-1241 Expected in the Second Half of 2024
Cash of
"Throughout 2023 and into the first quarter of 2024, we made remarkable progress advancing the clinical development of our two, next generation cardiometabolic assets, which address the significant metabolic dysfunction-associated steatohepatitis (MASH) and obesity markets," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "Most recently, we received Safety Review Committee (SRC) approval, recommending that the Phase 2a clinical trial for DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for treating MASH, continue without modification. The SRC recommendation was based on no significant safety trends found in the first six months of study conduct, which is an early indication of the safety of DA-1241. Pre-clinical safety data, reported in January, showed promising results for DA-1241 in combination with sitagliptin, a DPP4 inhibitor. Enrollment for Part 2 has also begun, indicating a strong commitment to the timely development of our pipeline programs. As previously reported, based on the pre-clinical evidence to date, DA-1241 has been shown to effectively improve hepatic and systemic inflammation, with the sitagliptin combination therapy showing synergistic anti-inflammatory effects. The drug has also been shown to be well tolerated in both healthy volunteers and patients with type 2 diabetes mellitus (T2DM). We continue to believe that DA-1241 has the potential to be a safe and effective treatment for MASH and look forward to reporting full trial data in the second half of this year.
"Our second asset, DA-1726, a novel oxyntomodulin (OXM) analogue acting as a GLP1R and GCGR dual agonist, is currently in preparations for a Phase 1 study for the treatment of obesity. In February of this year, shortly after the
Mr. Kim concluded, "It is an exciting time at NeuroBo and to add to this, I would like to welcome Marshall Woodworth, who was recently appointed as our permanent Chief Financial Officer. He has already made a significant impact on the company and its financial operations and his continued contributions to the team will be key as we continue to execute on the clinical development of our two promising cardiometabolic assets."
Fourth Quarter 2023 and Subsequent Highlights
- March 2024: Received SRC approval recommending that the two-part Phase 2a trial of DA-1241 for the treatment of MASH continue without modification following a blinded safety review of the first six months of study conduct.
- March 2024: Announced the appointment of Marshall Woodworth as Chief Financial Officer, following his tenure as Acting Chief Financial Officer.
- February 2024: Received first site Institutional Review Board (IRB) approval for Alexander Prezioso, M.D., Investigator, Clinical Pharmacology of
Miami , inHialeah, FL , to proceed with the Phase 1 clinical trial of DA-1726 for the treatment of obesity. - February 2024: Announced that the FDA has cleared its Investigational New Drug (IND) application for the Phase 1 trial DA-1726 in obesity, previously submitted in December 2023.
- January 2024: Reported positive pre-clinical safety data of DA-1241 in combination with sitagliptin, a DPP4 inhibitor. The pre-clinical results demonstrated that once daily oral administration in rats, of sitagliptin alone (180 mg/kg/day), DA-1241 alone (100 mg/kg/day), or sitagliptin in combination with DA-1241 (up to 180/100 mg/kg/day sitagliptin+DA-1241) for 13 weeks, was well tolerated with no adverse effects. Additionally, the company announced it had opened enrollment for Part 2 of its Phase 2a clinical trial of DA-1241 when co-administered with sitagliptin for the treatment of MASH.
- December 2023: Effected a 1-for-8 reverse stock split to regain compliance with the Nasdaq minimum bid price requirement. On January 8, 2024, company received notification from Nasdaq that it had regained compliance.
- November 2023: Appointed James P. Tursi, M.D., a pharmaceutical industry veteran, to its Board of Directors and as a member of the Board's Nominating and Governance Committee.
Anticipated Clinical Milestones
- DA-1241 in MASH: Full data from the Phase 2a clinical trial of DA-1241 in MASH is expected to be available in the second half of 2024.
- DA-1726 in Obesity: Initiation of a Phase 1 single ascending dose (SAD) study and multiple ascending dose (MAD) study, expected in the second quarter of 2024. Top-line data from the single ascending dose (SAD) Part 1 is expected in the first half of 2025 and from the multiple ascending dose (MAD) Part 2 in the second half of 2025.
Full Year 2023 Financial and Operating Results
- Research and Development (R&D) Expenses were approximately
$9.2 million $2.8 million $6.4 million $6.3 million $0.1 million $0.1 million - General and Administrative Expenses were approximately
$6.7 million $8.6 million $1.9 million $0.9 million $0.7 million $0.3 million $0.3 million $0.2 million - Total Operating Expenses were approximately
$15.9 million $19.6 million $3.7 million $8.2 million $1.9 million $6.4 million - Other Income was approximately
$3.4 million $5.7 million $5.0 million $0.5 million $2.3 million - Net Loss for the year ended December 31, 2023, was
$12.5 million $2.46 $14.0 million $43.42 - Cash was
$22.4 million $33.4 million
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Type 2 diabetes mellitus (T2DM), and is developing DA-1726 for the treatment of obesity. 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 preclinical 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. 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.
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", "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; 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 our contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between our 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; our 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; effects of changes in applicable laws or regulations; 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.
Contacts: | ||
NeuroBo Pharmaceuticals | ||
Marshall H. Woodworth | Michael Miller | |
Chief Financial Officer | +1-917-633-6086 | |
+1-857-299-1033 | ||
- Tables to Follow -
NeuroBo Pharmaceuticals, Inc. | ||||||
Condensed Consolidated Balance Sheets | ||||||
(in thousands, except share amounts and par value) | ||||||
As of December 31, | ||||||
2023 | 2022 | |||||
Assets | ||||||
Current assets: | ||||||
Cash | $ | 22,435 | $ | 33,364 | ||
Prepaid and other current assets | 77 | 168 | ||||
Total current assets | 22,512 | 33,532 | ||||
Property and equipment, net | 46 | 2 | ||||
Right-of-use asset | 202 | — | ||||
Other assets | 21 | — | ||||
Total assets | $ | 22,781 | $ | 33,534 | ||
Liabilities and stockholders' equity | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 821 | $ | 708 | ||
Accrued liabilities | 4,414 | 280 | ||||
Warrant liabilities | 658 | 10,796 | ||||
Lease liability, short-term | 67 | — | ||||
Total current liabilities | 5,960 | 11,784 | ||||
Lease liability, long-term | 136 | — | ||||
Total liabilities | 6,096 | 11,784 | ||||
Commitments and contingencies (Note 4) | ||||||
Stockholders' equity | ||||||
Preferred stock, | — | — | ||||
Common stock, | 5 | 25 | ||||
Additional paid–in capital | 124,945 | 117,520 | ||||
Accumulated deficit | (108,265) | (95,795) | ||||
Total stockholders' equity | 16,685 | 21,750 | ||||
Total liabilities and stockholders' equity | $ | 22,781 | $ | 33,534 | ||
NeuroBo Pharmaceuticals, Inc. | ||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||
(in thousands, except share and per share amounts) | ||||||
Year Ended December 31, | ||||||
2023 | 2022 | |||||
Operating expenses: | ||||||
Research and development | $ | 9,158 | $ | 2,778 | ||
Acquired in-process research and development | — | 8,210 | ||||
General and administrative | 6,728 | 8,640 | ||||
Total operating expenses | 15,886 | 19,628 | ||||
Loss from operations | (15,886) | (19,628) | ||||
Other income (expense): | ||||||
Change in fair value of warrant liabilities | 2,955 | 7,935 | ||||
Interest income | 461 | — | ||||
Financing expense | — | (2,191) | ||||
Other expense | — | (83) | ||||
Total other income | 3,416 | 5,661 | ||||
Loss before income taxes | (12,470) | (13,967) | ||||
Provision for income taxes | — | — | ||||
Net loss | $ | (12,470) | $ | (13,967) | ||
Loss per share of common stock, basic and diluted | $ | (2.46) | $ | (43.42) | ||
Weighted average shares of common stock, basic and diluted | 5,071,101 | 321,703 | ||||
Comprehensive loss: | ||||||
Net loss | $ | (12,470) | $ | (13,967) | ||
Other comprehensive loss, net of tax | — | (4) | ||||
Comprehensive loss | $ | (12,470) | $ | (13,971) | ||
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SOURCE NeuroBo Pharmaceuticals, Inc.
FAQ
What approvals did NeuroBo Pharmaceuticals, Inc. receive for its clinical trials related to obesity and MASH?
What positive data did NeuroBo report regarding DA-1241?
What is NeuroBo's cash position as of December 31, 2023, and how long is it expected to fund operations?
