Health

NeuroBo Pharmaceuticals Reports First Quarter 2021 Financial Results

BOSTON, May 17, 2021 — NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced financial results for the first quarter ended March 31, 2021.

First Quarter Achievements

Broadened the potential for product candidate, Gemcabene, by amending its Contingent Value Rights (CVR) agreement with the holders of the outstanding CVRs, to incentivize the evaluation of Gemcabene as a treatment for COVID-19. The CVRs were distributed to the holders of Gemphire Therapeutics, Inc. common stock on December 30, 2019, immediately prior to its merger with NeuroBo.

The CVR amendment will allow NeuroBo to pursue Gemcabene as a therapy for COVID-19, with its own resources. In exchange, CVR holders will receive 10% of certain gross proceeds received by the company for any indication outside of treating cardiometabolic diseases. CVR holders will retain the original CVR for 80% of any proceeds of Gemcabene for cardiovascular conditions.

Strengthened the balance sheet with the successful completion of a private placement of 2.5 million shares of common stock and warrants to purchase up to an aggregate 2.5 million shares of common stock, with aggregate gross proceeds to the company of $10.0 million and net proceeds to the company of approximately $9.2 million.

Management Commentary

“Throughout the first quarter of 2021, we continued to make progress advancing the 60-patient Phase 2/3 clinical trial of our lead drug candidate, ANA001, a proprietary oral niclosamide formulation, as a treatment for moderate to severe COVID-19,” stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo.

“We remain on track to report the data monitoring committee safety results of this study and pharmacokinetic (PK) data from the Phase 1 in the second quarter. In order to enhance enrollment in the Phase 2/3 study, we are in the process of expanding to sites in the U.S. where the number of COVID-19 cases are increasing and including clinical sites in countries overseas where COVID-19 is growing and vaccinations are well behind the U.S.  In addition, we expect to report preclinical in vitro data demonstrating Gemcabene’s ability to treat COVID-19 variants alone and in combination with ANA001.”

Dr. Kang continued, “Our plans moving forward with NB-01 and NB-02 remain under evaluation as we focus our resources on advancing our COVID-19 franchise with ANA001 and Gemcabene.  With our recent fund raise, we believe NeuroBo has the financial foundation to fund operations at the current level into the fourth quarter of 2021 and we expect to achieve a number of value-creating milestones with our COVID-19 programs in the coming months.”

First Quarter 2021 Financial and Operating Results

Research and Development (R&D) Expenses were approximately $1.1 million for the quarter ended March 31, 2021, compared with approximately $2.2 million for the quarter ended March 31, 2020.  The $1.0 million decrease was primarily attributed to overall Contract Research Organization termination costs associated with the Phase 3 clinical trials of NB-01 in the amount of $0.7 million and the further development of Gemcabene under the CVR Agreement in the amount of $0.4 million that occurred during the first quarter of 2020 with a small offset for increased research activities in the first quarter of 2021 when compared with the comparable quarter in the prior year.

General and Administrative Expenses were $2.2 million for the three months ended March 31, 2021, compared with $2.6 million for the three months ended March 31, 2020. The decrease of $0.4 million was primarily due to a reduction in transactional related costs in the amount of $0.3 million with regard to the company’s acquisitions when compared with the comparable quarter in the prior year. In addition, there was a reduction in legal costs in the amount of $0.2 million in the current quarter associated with the streamlining of the company’s intellectual property portfolio, offset in part by increases in insurance premium costs during the current quarter of $0.1 million.

Net Loss for the quarter ended March 31, 2021 was $3.3 million, or $0.15 per basic and diluted share, based on 21,615,626 weighted average common shares outstanding, compared with a net loss of $4.8 million, or $0.30 per basic and diluted share, based on 15,670,800 weighted average common shares outstanding for the quarter ended March 31, 2020.

Cash and Cash Equivalents were $13.0 million as of March 31, 2021, compared with $10.1 million as of December 31, 2020. Operating at its level of scientific activity during the quarter ended March 31, 2021, NeuroBo expects that its cash position will be adequate to fund operations into the fourth quarter of 2021.

About NeuroBo Pharmaceuticals

NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on developing and commercializing multi-modal disease-modifying therapies for viral, neuropathic, and neurodegenerative diseases, has a current portfolio of four drug candidates. The company’s recently acquired ANA001 candidate is a proprietary oral niclosamide formulation in development as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators).
Niclosamide is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans. ANA001 is currently being studied in a 60-subject Phase 2/3 clinical trial conducted at up to 20 clinical sites in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. The company’s NB-01 candidate has been shown in a Phase 2 study to significantly reduce pain symptoms associated with painful diabetic neuropathy (PDN), with a superior safety profile when compared to currently available treatments. Due to the global COVID-19 crisis, a planned Phase 3 study of NB-01 was postponed.
In the interim, NeuroBo is exploring a potential orphan drug indication targeting chronic pain for NB-01. NeuroBo’s NB-02 drug candidate 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 fourth program, Gemcabene, was previously being developed for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease. Gemcabene is currently being assessed as an acute treatment for COVID-19.

– Tables to Follow –

NeuroBo Pharmaceuticals, Inc.

Consolidated Balance Sheets

(in thousands, except share amounts and par value)

March 31, 

December 31, 

2021

2020

(unaudited)

Assets

Current assets:

 Cash

$

13,035

$

10,089

 Prepaid expenses

831

546

 Other assets

28

48

Total current assets

13,894

10,683

Right-of-use assets and other

123

130

Property and equipment, net

143

155

Total assets

$

14,160

$

10,968

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$

468

$

2,575

Accrued liabilities

452

1,096

Lease liability, short-term

24

24

Total current liabilities

944

3,695

Lease liability, long-term

65

70

Total liabilities

1,009

3,765

Commitments and contingencies (Notes 4, 5, 6 and 11)

Stockholders’ equity

Preferred stock, $0.001 par value; 10,000,000 shares authorized as of

March 31, 2021 and December 31, 2020; no shares issued or outstanding

as of March 31, 2021 and December 31, 2020.

Common stock, $0.001 par value per share, 100,000,000 shares authorized

as of March 31, 2021 and December 31, 2020; 22,171,182 and 19,671,182

shares issued and outstanding as of March 31, 2021 and December 31, 2020,

respectively.

22

20

Additional paid–in capital

82,990

73,713

Accumulated other comprehensive income

7

14

Accumulated deficit

(69,868)

(66,544)

Total stockholders’ equity

13,151

7,203

Total liabilities and stockholders’ equity

$

14,160

$

10,968

NeuroBo Pharmaceuticals, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(unaudited)

For the Three Months Ended

March 31, 

2021

2020

Operating expenses:

Research and development

$

1,143

$

2,152

General and administrative

2,187

2,597

Total operating expenses

3,330

4,749

Loss from operations

(3,330)

(4,749)

Interest income

6

20

Other income (expense), net

(1)

Loss before income taxes

(3,324)

(4,730)

Provision for income taxes

Net loss

(3,324)

(4,730)

Other comprehensive loss, net of tax

(7)

(34)

Comprehensive loss

$

(3,331)

$

(4,764)

Loss per share:

Net loss per share, basic and diluted

$

(0.15)

$

(0.30)

Weighted average common shares outstanding:

Basic and diluted

21,615,626

15,670,800

This article was shared with Prittle Prattle News as a Press Release by PRNewswire.

Related Posts

1 of 848