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
"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
First Quarter 2024 and Subsequent Highlights
April 2024 : Dosed the first patient in the SAD Part 1 of its two-part Phase 1 clinical trial of DA-1726 for the treatment of obesity.April 2024 : Completed enrollment of Part 1 of its two-part Phase 2a trial evaluating the efficacy and safety of DA-1241 in MASH. Approximately 49 patients with presumed MASH were randomized into Part 1 with a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo.March 2024 : Received SRC approval to continue the two-part Phase 2a trial of DA-1241 for the treatment of MASH without modification following a blinded safety review of the first six months of study conduct.March 2024 : Announced the appointment ofMarshall Woodworth as Chief Financial Officer, following his tenure as Acting Chief Financial Officer.February 2024 : Received first siteInstitutional Review Board (IRB) approval forAlexander Prezioso , M.D., Investigator, Clinical Pharmacology ofMiami , 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 clinical trial of DA-1726 in obesity.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, opened enrollment for Part 2 of its Phase 2a clinical trial of DA-1241 when co-administered with sitagliptin for the treatment of MASH.
Anticipated Clinical Milestones
- DA-1726 in Obesity: Top-line data from the single ascending dose (SAD) Part 1 is expected in the third quarter of 2024. Initiation of the multiple ascending dose (MAD) study Part 2 is expected in the third quarter of 2024 and the top-line data expected in the first quarter of 2025.
- DA-1241 in MASH: Full enrollment of the two-part Phase 2a clinical trial of DA-1241 in MASH is expected in the third quarter of 2024. Top-line results are expected to be available in the fourth quarter of 2024.
First Quarter Financial and Operating Results
- Research and Development (R&D) Expenses were approximately
$4.9 million for the three months endedMarch 31, 2024 , as compared to approximately$0.6 million for the three months endedMarch 31, 2023 . The increase of approximately$4.3 million was primarily attributable to increased development activities for DA-1241 and DA-1726. Specifically, the$4.3 million increase in R&D expenses was primarily attributable to (i)$3.9 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting and (ii)$0.4 million in higher employee compensation and benefits. - General and Administrative Expenses were approximately
$2.0 million for the three months endedMarch 31, 2024 , compared to approximately$1.9 million for the three months endedMarch 31, 2023 . The increase of approximately$0.1 million was primarily attributable to$0.2 million in higher non-cash stock-based compensation, partially offset by$0.1 million in lower legal and professional fees. - Other Income (Expense) was approximately
$0.2 million for the three months endedMarch 31, 2024 , compared to approximately ($0.1 million ) for the three months endedMarch 31, 2023 . The change was primarily attributable to$0.2 million of interest income earned on our cash balance for the three months endedMarch 31, 2024 , of which there was none for the three months endedMarch 31, 2023 . - Net Loss for the three months ended
March 31, 2024 , was approximately$6.7 million , or$1.32 per basic and diluted share, based on 5,089,408 weighted average shares of common stock, basic and diluted, compared with a net loss of approximately$2.6 million , or$0.51 per basic and diluted share, based on 5,059,003 weighted average shares of common stock, basic and diluted, for the three months endedMarch 31, 2023 . - Cash was approximately
$16.0 million as ofMarch 31, 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 fourth quarter of 2024 and we are currently exploring various financing alternatives.
About
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
Contacts:
Chief Financial Officer
+1-857-299-1033
marshall.woodworth@neurobopharma.com
+1-917-633-6086
mmiller@rxir.com
- Tables to Follow -
|
||||||
Condensed Consolidated Balance Sheets |
||||||
(In thousands, except per share amounts) |
||||||
As of |
||||||
|
|
|||||
(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 |
$ |
2,079 |
$ |
821 |
||
Accrued liabilities (including related party payable of |
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, |
— |
— |
||||
Common stock, |
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 |
|
||||||
Condensed Consolidated Statements of Operations |
||||||
(Unaudited - In thousands, except share and per share amounts) |
||||||
Three Months Ended |
||||||
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 |
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