NeuroBo Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Corporate Update
NRBO 11.07.2024
Drug:DA-1726-OBESITY DA-1726
Drug:DA-1241-MASH DA-1241
Diseases:Obesity
Diseases:MASH
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
"To further differentiate DA-1726, early in the quarter, we signed a joint research agreement, together with our collaboration partner,
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 withDong-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, providingMThera 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 inthe 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) Expenseswere approximately
$4.5 million for the three months endedSeptember 30, 2024 , as compared to approximately$2.3 million for the three months endedSeptember 30, 2023 . The increase of approximately$2.2 million was primarily related to increased R&D activities for DA-1241 and DA-1726 for the three months endedSeptember 30, 2024 related to the Phase 2a clinical trial for DA-1241 and Phase 1 trial for DA-1726. Specifically, the$2.2 million increase in R&D expenses was attributable to (i)$1.9 million in higher expenditures for clinical trials, non-clinical and preclinical services, and consulting and (ii)$0.3 million in higher employee compensation and benefits. Included in R&D expenses for the three months endedSeptember 30, 2024 was$0.7 million of non-clinical and preclinical expenses incurred under the Shared Services Agreement withDong-A ST as compared to$0.4 million for the three months endedSeptember 30, 2023 .R&D expenses were approximately$17.5 million for the nine months endedSeptember 30, 2024 , as compared to approximately$5.3 million for the nine months endedSeptember 30, 2023 . The approximately$12.2 million increase was primarily related to increased R&D activities related to Phase 2a clinical trial for DA-1241 and a Phase 1 trial for DA-1726 for the nine months endedSeptember 30, 2024 when R&D activities were starting to ramp up following the acquisition of DA-1241 and DA-1726 in the fourth quarter of 2022. Specifically, the$12.2 million increase in R&D expenses was attributable to (i)$11.2 million in higher expenditures for clinical trials, investigational drug manufacturing costs, non-clinical and preclinical services, and consulting and (ii)$1.0 million in higher employee compensation and benefits. Included in R&D expenses for the nine months endedSeptember 30, 2024 was$4.3 million of investigational drug manufacturing costs and non-clinical and preclinical expenses incurred under the Shared Services Agreement withDong-A ST as compared to$2.2 million for the nine months endedSeptember 30, 2023 . - General and Administrative (G&A) Expenseswere approximately
$1.7 million for the three months endedSeptember 30, 2024 , compared to approximately$1.6 million for the three months endedSeptember 30, 2023 . The increase of approximately$0.1 million was primarily attributable to$0.2 million in higher employee compensation and benefits, partially offset by$0.1 million in lower legal and professional fees.G&A expenses were approximately$5.7 million for the nine months endedSeptember 30, 2024 , as compared to approximately$4.9 million for the nine months endedSeptember 30, 2022 . The approximately$0.8 million increase was primarily attributable to$0.9 million in higher employee compensation and benefits, partially offset by$0.1 million in lower legal and professional fees. - Total Other Incomewas approximately
$0.6 million for the three months endedSeptember 30, 2024 , as compared to approximately$0.1 million for the three months endedSeptember 30, 2023 . The approximately$0.5 million increase was attributable to the recording of a gain of$0.3 million related to the change in fair value of warrant liabilities for the three months endedSeptember 30, 2024 compared to a loss of$0.1 million for the three months endedSeptember 30, 2023 , and$0.1 million in higher interest income earned on our cash balance.Total other income was approximately$0.8 million for the nine months endedSeptember 30, 2024 , as compared to approximately$3.1 million for the nine months endedSeptember 30, 2023 . The approximately$2.3 million decrease was primarily attributable to$2.8 million in lower gain related to the change in fair value of warrant liabilities, partially offset by$0.5 million of higher interest income earned on our cash balance. - Net Lossfor the three months ended
September 30, 2024 , was approximately$5.7 million , or$0.55 per basic and diluted share, based on 10,214,087 weighted average shares of common stock, basic and diluted, compared with a net loss of approximately$3.8 million , or$0.75 per basic and diluted share, based on 5,075,817 weighted average shares of common stock, basic and diluted, for the three months endedSeptember 30, 2023 .Net loss for the nine months endedSeptember 30, 2024 , was approximately$22.4 million , or$3.24 per basic and diluted share, based on 6,922,338 weighted average shares of common stock, basic and diluted, compared with a net loss of approximately$7.2 million , or$1.41 per basic and diluted share, based on 5,064,670 weighted average shares of common stock, basic and diluted, for the nine months endedSeptember 30, 2023 . - Cashwas approximately
$21.7 million as ofSeptember 30, 2024 , compared to approximately$22.4 million as ofDecember 31, 2023 . The Company expects its cash position will be adequate to fund operations into the third quarter of 2025.
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Forward Looking StatementsCertain 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
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- Tables to Follow -
NeuroBo Pharmaceuticals, Inc. | ||||||
Condensed Consolidated Balance Sheets | ||||||
(In thousands, except per share amounts) | ||||||
As of | ||||||
(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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