BOSTON, Aug. 11, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. NRBO, a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced financial results for the second quarter ended June 30, 2020.
"As planned, throughout the second quarter, our Board, management and scientific team evaluated a number of potential options for advancing the NB-01 clinical asset through different regulatory pathways," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. "Development of NB-01 as an orphan drug is key among the alternatives we are considering, and we may conduct feasibility studies to identify a specific rare disease relevant to this product candidate. While we had considered marketing NB-01 as a nutraceutical product, we have now determined not to pursue this pathway at this time."
Dr. Kang continued, "We are preparing an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for NB-02. We intend to postpone the first human clinical trials for NB-02 until global health and macroeconomic conditions improve, with a view toward commencing clinical trial activity in the first half of 2021, subject to improvement of the constraints imposed by the COVID-19 pandemic. We are also considering engaging with a strategic partner to assist with clinical trials for NB-02."
The Company previously announced, in May 2020, that it received written communication from the FDA stating that the clinical development program for Gemcabene remains on a partial clinical hold. The Company is reviewing its options regarding Gemcabene.
Second Quarter Financial and Operating Results Highlights
Upon the merger between Gemphire Therapeutics, Inc. and NeuroBo Pharmaceuticals, Inc. at year-end 2019, the formerly private NeuroBo was considered the accounting acquirer. In accordance with generally accepted accounting principles, the historical financial statements of private company, NeuroBo, are considered the financial statements of the combined company, with the merger accounted for as an acquisition of the Gemcabene family of related assets on December 30, 2019. The following highlights, therefore, represent the combined operations of both companies for the quarter ended June 30, 2020 and the operations of NeuroBo as a private company for the comparable quarter ended June 30, 2019.
- Research and Development (R&D) Expenses were approximately $0.7 million for the three months ended June 30, 2020 compared with approximately $0.9 million for the three months ended June 30, 2019. The approximately $0.3 million decrease in the second quarter of 2020 was primarily due to the overall reduction of clinical trial activity given the March 2020 decision to postpone Phase 3 clinical trials of NB-01. R&D expenses during the three months ended June 30, 2020 and 2019 included stock-based compensation of $4,000 and $16,000, respectively.
- General and Administrative Expenses were $1.7 million for the three months ended June 30, 2020, compared with $0.9 million for the three months ended June 30, 2019. The increase of $0.8 million was primarily due to the ramp up costs associated with operating and reporting as a public company and to post-Merger support costs in the second quarter of 2020. Stock-based compensation costs during the three-month periods ended June 30, 2020 and 2019 were $0.2 million and $63,000, respectively.
- Net Loss for the second quarter ended June 30, 2020 was approximately $2.4 million, or $0.15 per basic and diluted share, based on 16,303,681 weighted average common shares outstanding, compared with a net loss of approximately $1.9 million, or $0.37 per basic and diluted share, based on 5,166,812 weighted average common shares outstanding for the same period in 2019.
- Cash and Cash Equivalents were $14.3 million as of June 30, 2020, compared with $13.9 million at December 31, 2019. The Company expects that its cash position, which includes the net proceeds from the April 2020 registered direct common stock offering, will be adequate to fund operations into the second quarter of 2021.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative and cardiometabolic diseases affecting millions of patients worldwide. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The company's drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN), has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. Due to global COVID-19 crisis, a planned Phase 3 study was postponed. In the interim, NeuroBo is exploring a potential orphan drug indication targeting chronic pain for NB-01. NeuroBo's drug candidate, NB-02, is focused on the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. The company's third program, Gemcabene, is focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease.
NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. In December 2019, NeuroBo merged with Gemphire Therapeutics and through such merger, became listed on the Nasdaq Stock Market and added the Gemcabene family of related assets to its portfolio. For more information visit: https://www.neurobopharma.com.
Forward Looking Statements
Any statements in this press release that are not statements of historical fact constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, statements regarding the development of NeuroBo's product candidates and the therapeutic potential, timing and nature of clinical trials and potential regulatory approval of NeuroBo's clinical programs and pipeline. Forward-looking statements are usually identified by the use of words, such as "believes," "anticipates," "expects," "intends," "plans," "may," "potential," "will," "could" and similar expressions. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors and risks. These factors, risks and uncertainties include, but are not limited to: the occurrence of health epidemics or contagious diseases, such as COVID-19, and potential effects on NeuroBo's business, clinical trial sites, supply chain and manufacturing facilities; NeuroBo's ability to continue as a going concern; the timing of completion of NeuroBo's planned clinical trials; the timing of the availability of data from NeuroBo's clinical trials; NeuroBo's plans to research, develop and commercialize its current and future product candidates, including the potential alternative pathways for NB-01; NeuroBo's ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo's product candidates; the impact of government laws and regulations; NeuroBo's ability to protect its intellectual property position; and NeuroBo's need for additional financing to fulfill its stated goals; and other factors discussed in the "Risk Factors" section of NeuroBo's Annual Report on Form 10-K and in our other filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent NeuroBo's views as of the date hereof. NeuroBo anticipates that subsequent events and developments will cause its views to change. However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing NeuroBo's views as of any date subsequent to the date hereof.
Contacts:
Rx Communications Group
Melody Carey
+1-917-322-2571
mcarey@rxir.com
- Tables to Follow -
NeuroBo Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (in thousands, except share amounts and par value) | |||||||
June 30, | December 31, | ||||||
2020 | 2019 | ||||||
(unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash | $ | 14,298 | $ | 13,908 | |||
Restricted cash | — | 15 | |||||
Prepaid expenses | 908 | 153 | |||||
Other assets | 37 | 42 | |||||
Total current assets | 15,243 | 14,118 | |||||
Right-of-use assets | 105 | 116 | |||||
Property and equipment, net | 172 | 200 | |||||
Other assets | 32 | 34 | |||||
Total assets | $ | 15,552 | $ | 14,468 | |||
Liabilities and stockholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,683 | $ | 638 | |||
Accrued liabilities | 1,426 | 1,422 | |||||
Lease liability, short-term | 23 | 22 | |||||
Total current liabilities | 3,132 | 2,082 | |||||
Lease and other long-term liabilities | 82 | 94 | |||||
Total liabilities | 3,214 | 2,176 | |||||
Commitments and contingencies | |||||||
Stockholders' equity: | |||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares | — | — | |||||
Common stock, $0.001 par value per share, 100,000,000 shares authorized; | 17 | 16 | |||||
Additional paid–in capital | 56,317 | 49,130 | |||||
Accumulated other comprehensive (loss) income | (16) | 12 | |||||
Accumulated deficit | (43,980) | (36,866) | |||||
Total stockholders' equity | 12,338 | 12,292 | |||||
Total liabilities and stockholders' equity | $ | 15,552 | $ | 14,468 | |||
NeuroBo Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (unaudited) | |||||||||||||
For the Three Months Ended | For the Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||
Operating expenses: | |||||||||||||
Research and development | $ | 674 | $ | 948 | $ | 2,826 | $ | 2,748 | |||||
General and administrative | 1,718 | 939 | 4,315 | 1,590 | |||||||||
Total operating expenses | 2,392 | 1,887 | 7,141 | 4,338 | |||||||||
Loss from operations | (2,392) | (1,887) | (7,141) | (4,338) | |||||||||
Interest income (expense), net | 8 | (14) | 28 | (27) | |||||||||
Other expense, net | — | — | (1) | — | |||||||||
Loss before income taxes | (2,384) | (1,901) | (7,114) | (4,365) | |||||||||
Provision for income taxes | — | — | — | — | |||||||||
Net loss | (2,384) | (1,901) | (7,114) | (4,365) | |||||||||
Other comprehensive loss: | |||||||||||||
Foreign currency translation loss, net of tax | 6 | 11 | (28) | 9 | |||||||||
Total other comprehensive loss | 6 | 11 | (28) | 9 | |||||||||
Comprehensive loss | $ | (2,378) | $ | (1,890) | $ | (7,142) | $ | (4,356) | |||||
Loss per share: | |||||||||||||
Net loss per share, basic and diluted | $ | (0.15) | $ | (0.37) | $ | (0.44) | $ | (0.84) | |||||
Weighted average common shares outstanding: | |||||||||||||
Basic and diluted | 16,303,681 | 5,166,812 | 15,987,240 | 5,166,812 | |||||||||
View original content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-second-quarter-2020-financial-results-301110298.html
SOURCE NeuroBo Pharmaceuticals, Inc.
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