NeuroBo Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update
DA-1726 Phase 1 IND Filing Expected by Year End 2023
Board Strengthened with Recent Appointment of Industry Veteran,
Cash and Cash Equivalents of
"During the third quarter, we continued to advance the clinical development of our two, next generation cardiometabolic assets, which address the significant nonalcoholic steatohepatitis (
"As it relates to our second asset, DA-1726, a novel oxyntomodulin (OXM) analogue which acts as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist, DA-1726 has shown highly encouraging results in preclinical testing including reduced food intake via activation of the GLP-1 receptor as well as increased energy expenditure via glucagon activation. Specifically, in obese mouse models, DA-1241 elicits similar weight loss efficacy compared to Tirzepatide, even while consuming more food, and has exhibited superior weight loss compared to Semaglutide, while also showing further improvements in hepatic steatosis, inflammation, and fibrosis. As a result, we believe DA-1726 will be an effective therapy to address the growing obesity market. We intend to continue to advance DA-1726 through the Investigational New Drug (IND) process during the fourth quarter of this year. If the IND is accepted by the
Third Quarter 2023 and Subsequent Highlights
November 2023 : AppointedJames P. Tursi , M.D., a pharmaceutical industry veteran, to its Board of Directors and as a member of the Board's Nominating Committee.September 2023 : Dosed the first patient in the Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, for the treatment ofNASH , atThe Pinnacle Edinberg/South Texas Research Institute inEdinburg, Texas , under the supervision of Principal Investigator, Dr.David Ramirez .August 2023 : Appointed current Board member,Hyung Heon Kim , as the Company's President and Chief Executive Officer.August 2023 : Received the first site IRB approval forZeid Kayali , M.D., Medical Director atInland Empire Liver Foundation , inRialto, CA , to proceed with the Phase 2a clinical trial of DA-1241, for the treatment ofNASH .August 2023 : Signed a term sheet with MTHERA to out-license the worldwide rights, excludingKorea , for NB-01, for the treatment of painful diabetic neuropathy, and allowing MTHERA to conduct research in order to seek new patents for NB-01 and conduct clinical trials, including, but not limited to, a potential Phase 3 clinical trial inthe United States for the future commercialization of NB-01.
Anticipated Clinical Milestones
- DA-1241 in
NASH : Data from an interim analysis of the Phase 2a clinical trial of DA-1241 inNASH expected to be available in the first half of 2024. The full data readout is expected in the second half of 2024. - DA-1726 in Obesity: IND submission for a Phase 1 single ascending dose (SAD) study and multiple ascending dose (MAD) study, expected by year end 2023. Initiation of the Phase 1a safety study targeted for the first half of 2024, pending IND acceptance by the FDA, with a data readout expected in the second half of 2024.
Third Quarter 2023 Financial and Operating Results
- Research and Development (R&D) Expenses were approximately
$2.3 million for the three months endedSeptember 30, 2023 as compared to approximately$0.6 million for the three months endedSeptember 30, 2022 . The increase of approximately$1.7 million was primarily due to costs related to the Company's clinical trial of DA-1241 which was initiated in the third quarter of 2023, including increases in clinical trial costs and toxicology studies of$1.3 million and$0.4 million , respectively.
For the nine months endedSeptember 30, 2023 , R&D expenses were approximately$5.3 million , as compared to approximately$2.5 million for the nine months endedSeptember 30, 2022 . The increase of approximately$2.8 million was primarily due to costs related to the Company's clinical trial of DA-1241 which was initiated in the third quarter of 2023, including increases in clinical trial costs, toxicology studies and related drug manufacturing of$0.9 million ,$1.6 million , and$0.5 million , respectively. The increase was partially offset by a decrease of$0.2 million in general research and development overhead, as the Company was finishing the ANA001 study.
- General and Administrative Expenses were approximately
$1.6 million for the three months endedSeptember 30, 2023 , compared to approximately$2.5 million for the three months endedSeptember 30, 2022 . The decrease of approximately$0.9 million was primarily due to a decrease in professional fees of$0.7 million related to the exploration of business opportunities during the three months endedSeptember 30, 2022 , as well as a decrease in insurance costs of approximately$0.2 million .
For the nine months endedSeptember 30, 2023 , G&A expenses were approximately$4.9 million , as compared to approximately$6.7 million for the nine months endedSeptember 30, 2022 . The decrease of approximately$1.8 million was primarily due to a decrease in professional fees of$1.0 million chiefly related to the exploration of business opportunities during the nine months endedSeptember 30, 2022 , as well as a decrease in insurance costs of approximately$0.7 million and a decrease in stock-based compensation of$0.5 million , offset partially by increases in payroll and executive consultant fees in the aggregate of$0.4 million .
- Net Loss for the three months ended
September 30, 2023 was$3.8 million , or$0.09 per basic and diluted share, based on 40,606,537 weighted average shares of common stock outstanding, compared with a net loss of$3.1 million , or$3.50 per basic and diluted share, based on 888,693 weighted average shares of common stock outstanding for the three months endedSeptember 30, 2022 .
Net Loss for the nine months endedSeptember 30, 2023 was$7.2 million , or$0.18 per basic and diluted share, based on 40,517,356 weighted average shares of common stock outstanding, compared with a net loss of$9.3 million , or$10.45 per basic and diluted share, based on 888,693 weighted average shares of common stock outstanding for the nine months endedSeptember 30, 2022 .
- Cash and Cash Equivalents were
$25.8 million as ofSeptember 30, 2023 , compared with$33.4 million as ofDecember 31, 2022 . The company expects its cash position will be adequate to fund operations at least into the fourth quarter of 2024.
About
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, including without limitation, statements about the closing of the offering of securities. 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 our ability to execute on our commercial strategy, the timeline for regulatory submissions, regulatory steps and potential regulatory approval of our current and future product candidates, the ability to realize the benefits of the license agreement with
Contact:
+1-917-633-6086
mmiller@rxir.com
ir@neurobopharma.com
- Tables to Follow -
Condensed Consolidated Balance Sheets (in thousands, except share amounts and par value) |
|||||||
|
|||||||
2023 |
|
||||||
(unaudited) |
2022 |
||||||
Assets |
|||||||
Current assets: |
|||||||
Cash |
$ |
25,837 |
$ |
33,364 |
|||
Prepaid expenses |
308 |
168 |
|||||
Total current assets |
26,145 |
33,532 |
|||||
Property and equipment, net |
41 |
2 |
|||||
Right-of-use asset |
218 |
— |
|||||
Other assets |
21 |
— |
|||||
Total assets |
$ |
26,425 |
$ |
33,534 |
|||
Liabilities and stockholders' equity |
|||||||
Current liabilities: |
|||||||
Accounts payable |
$ |
1,981 |
$ |
708 |
|||
Accrued liabilities |
1,614 |
280 |
|||||
Warrant liabilities |
1,062 |
10,796 |
|||||
Lease liability, short-term |
65 |
— |
|||||
Total current liabilities |
4,722 |
11,784 |
|||||
Lease liability, long-term |
153 |
— |
|||||
Total liabilities |
4,875 |
11,784 |
|||||
Commitments and contingencies (Note 4) |
|||||||
Stockholders' equity |
|||||||
Preferred stock, as of outstanding as of |
— |
— |
|||||
Common stock, authorized as of and 25,436,019 shares issued and outstanding as of and |
38 |
25 |
|||||
Additional paid–in capital |
124,463 |
117,520 |
|||||
Accumulated deficit |
(102,951) |
(95,795) |
|||||
Total stockholders' equity |
21,550 |
21,750 |
|||||
Total liabilities and stockholders' equity |
$ |
26,425 |
$ |
33,534 |
Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (unaudited) |
||||||||||||
For the Three Months Ended |
For the Nine Months Ended |
|||||||||||
|
|
|||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||
Operating expenses: |
||||||||||||
Research and development |
$ |
2,292 |
$ |
571 |
$ |
5,293 |
$ |
2,473 |
||||
General and administrative |
1,601 |
2,533 |
4,926 |
6,725 |
||||||||
Total operating expenses |
3,893 |
3,104 |
10,219 |
9,198 |
||||||||
Loss from operations |
(3,893) |
(3,104) |
(10,219) |
(9,198) |
||||||||
Other income (expense): |
||||||||||||
Change in fair value of warrant liabilities |
(87) |
— |
2,901 |
— |
||||||||
Interest income |
162 |
— |
162 |
— |
||||||||
Other expense |
— |
(9) |
— |
(93) |
||||||||
Loss before income taxes |
(3,818) |
(3,113) |
(7,156) |
(9,291) |
||||||||
Provision for income taxes |
— |
— |
— |
— |
||||||||
Net loss |
(3,818) |
(3,113) |
(7,156) |
(9,291) |
||||||||
Other comprehensive loss, net of tax |
— |
— |
— |
(4) |
||||||||
Comprehensive loss |
$ |
(3,818) |
$ |
(3,113) |
$ |
(7,156) |
$ |
(9,295) |
||||
Loss per share: |
||||||||||||
Net loss per share, basic and diluted |
$ |
(0.09) |
$ |
(3.50) |
$ |
(0.18) |
$ |
(10.45) |
||||
Weighted average shares of common stock outstanding: |
||||||||||||
Basic and diluted |
40,606,537 |
888,693 |
40,517,356 |
888,693 |
||||||||
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