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NeuroBo Pharmaceuticals, Inc.
FORM 10-Q
INDEX
2
PART I – FINANCIAL INFORMATION
ITEM 1 – FINANCIAL STATEMENTS
NeuroBo Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share amounts and par value)
| September 30, |
| December 31, |
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2021 | 2020 |
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(unaudited) |
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Assets | |||||||
Current assets: | |||||||
Cash | $ | | $ | | |||
Prepaid expenses | | | |||||
Other assets |
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Total current assets |
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Right-of-use assets and other | | | |||||
Property and equipment, net |
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Total assets | $ | | $ | | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | | $ | | |||
Accrued liabilities |
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Lease liability, short-term | | | |||||
Total current liabilities |
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Lease liability, long-term | | | |||||
Total liabilities |
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Commitments and contingencies (Notes 4, 5, 6 and 11) | |||||||
Stockholders’ equity | |||||||
Preferred stock, $ | |||||||
Common stock, $ |
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Additional paid–in capital |
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Accumulated other comprehensive income | | | |||||
Accumulated deficit |
| ( |
| ( | |||
Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | |
See accompanying notes to condensed consolidated financial statements.
3
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 Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||
Operating expenses: |
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Research and development | $ | | $ | | $ | | $ | | |||||
General and administrative | | | | | |||||||||
Total operating expenses |
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Loss from operations |
| ( |
| ( |
| ( |
| ( | |||||
Interest income |
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Other expense, net |
| — |
| — |
| — |
| ( | |||||
Loss before income taxes | ( | ( | ( | ( | |||||||||
Provision for income taxes | — | — | — |
| — | ||||||||
Net loss |
| ( |
| ( |
| ( |
| ( | |||||
Other comprehensive (loss) income, net of tax |
| |
| |
| ( |
| ( | |||||
Comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Loss per share: | |||||||||||||
Net loss per share, basic and diluted | ( | ( | ( | ( | |||||||||
Weighted average common shares outstanding: | |||||||||||||
Basic and diluted |
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| |
| |
See accompanying notes to condensed consolidated financial statements.
4
NeuroBo Pharmaceuticals, Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
(in thousands, except share amounts)
(unaudited)
Additional | Accumulated |
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Common Stock | Paid–In | Comprehensive | Accumulated | Total |
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| Shares |
| Amount |
| Capital | Income (Loss) |
| Deficit |
| Equity | ||||||||
Balance at December 31, 2019 | | $ | | $ | | $ | | $ | ( | $ | | ||||||||
Exercise of stock options | | — | | — | — | | |||||||||||||
Stock–based compensation | — | — | | — | — | | |||||||||||||
Foreign currency translation adjustment | — | — | — | ( | — | ( | |||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||
Balance at March 31, 2020 | | | | ( | ( | | |||||||||||||
Issuance of common stock in connection with equity financing | | | | — | — | | |||||||||||||
Transaction costs in connection with equity financing | — | — | ( | — | — | ( | |||||||||||||
Stock–based compensation | — | — | | — | — | | |||||||||||||
Issuance of broker warrants in connection with equity financing | — | — | | — | — | | |||||||||||||
Foreign currency translation adjustment | — | — | — | | — | | |||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||
Balance at June 30, 2020 | | | | ( | ( | | |||||||||||||
Stock–based compensation | — | — | | — | — | | |||||||||||||
Foreign currency translation adjustment | — | — | — | | — | | |||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||
Balance at September 30, 2020 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||
Balance at December 31, 2020 | | $ | | $ | | $ | | $ | ( | $ | | ||||||||
Issuance of common stock and warrants in connection with equity financing | | | | — | — | | |||||||||||||
Transaction costs in connection with equity financing | — | — | ( | — | — | ( | |||||||||||||
Stock–based compensation | — | — | | — | — | | |||||||||||||
Foreign currency translation adjustment | — | — | — | ( | — | ( | |||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||
Balance at March 31, 2021 | | | | $ | | ( | | ||||||||||||
Stock–based compensation | — | — | | — | — | | |||||||||||||
Exercise of stock options | | — | | — | — | | |||||||||||||
Foreign currency translation adjustment | — | — | — | ( | — | ( | |||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||
Balance at June 30, 2021 | | | | | ( | | |||||||||||||
Stock–based compensation | — | — | | — | — | | |||||||||||||
Foreign currency translation adjustment | — | — | — | | — | | |||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||
Balance at September 30, 2021 | | $ | | $ | | $ | | $ | ( | $ | | ||||||||
See accompanying notes to condensed consolidated financial statements.
5
NeuroBo Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
For the Nine Months Ended |
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September 30, |
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2021 | 2020 |
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Operating activities | |||||||
Net loss | $ | ( | $ | ( | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Stock-based compensation |
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Non-cash lease expense | | | |||||
Depreciation |
| |
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Change in assets and liabilities | |||||||
Prepaid expenses and other assets |
| ( |
| ( | |||
Accounts payable |
| ( |
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Accrued and other liabilities |
| ( |
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Net cash used in operating activities |
| ( |
| ( | |||
Investing activities | |||||||
Purchases of property and equipment | ( | ( | |||||
Net cash used in investing activities |
| ( |
| ( | |||
Financing activities | |||||||
Proceeds from equity offering | | | |||||
Issuance costs | ( | ( | |||||
Exercise of stock options | | | |||||
Net cash provided by financing activities |
| |
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Net decrease in cash |
| ( |
| ( | |||
Net foreign exchange difference | ( | ( | |||||
Cash at beginning of period |
| |
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Cash at end of period | $ | | $ | | |||
Supplemental disclosure of cash flow information: | |||||||
Cash paid for income taxes | $ | — | $ | — | |||
Cash paid for interest | $ | — | $ | — | |||
Supplemental non-cash investing and financing transactions: | |||||||
Unpaid deferred issuance costs | $ | | $ | — | |||
Placement warrants issued in connection with equity financing | $ | — | $ | | |||
Unpaid fixed asset purchases | $ | — | $ | | |||
See accompanying notes to condensed consolidated financial statements.
6
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
1. The Company and Basis of Presentation
NeuroBo Pharmaceuticals, Inc. (together with its subsidiaries, the “Company” or “NeuroBo”), is a clinical-stage biotechnology company with four therapeutics programs designed to impact a range of indications in viral, neurodegenerative and cardiometabolic disease:
● | ANA001, which is focused on the development for coronavirus indications, is currently in Phase 2/3 clinical trials as a treatment for COVID-19; |
● | NB-01, which is primarily focused on the development of a treatment for painful diabetic neuropathy, but which the Company believes could also treat a range of neuropathic conditions, including chemotherapy-induced peripheral neuropathy and post-traumatic peripheral neuropathy; |
● | NB-02, which has the potential to treat the symptoms of cognitive impairment and modify the progression of neurodegenerative diseases associated with the malfunction of a protein called tau, and with amyloid beta plaque deposition; and |
● | Gemcabene, which is currently being assessed as an acute indication for COVID-19. Gemcabene was previously focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease, focused on orphan indications such as homozygous familial hypercholesterolemia, as well as nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. |
The Company was originally incorporated as Gemphire Therapeutics Inc. (“Gemphire”). In connection with the closing of the 2019 Merger (as defined below), the Company changed its name to NeuroBo Pharmaceuticals, Inc. The Company’s operations have consisted principally of performing research and development activities, clinical development and raising capital. The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved.
COVID-19
The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on the Company’s business is highly uncertain and difficult to predict, as the responses that the Company, other businesses and governments are taking continue to evolve. Furthermore, capital markets and economies worldwide have also been negatively impacted by the COVID-19 pandemic, and it is possible that it could cause a lasting national or global economic recession. Policymakers around the globe have responded with fiscal policy actions to support the healthcare industry and economy as a whole. The magnitude and overall effectiveness of these actions remain uncertain.
Exclusive of the development of certain of the Company’s proposed therapies, the severity of the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on the Company’s service providers, suppliers, contract research organizations and the Company’s clinical trials, all of which are uncertain and cannot be predicted. As of the date of issuance of Company’s financial statements, the extent to which the COVID-19 pandemic may in the future materially impact the Company’s financial condition, liquidity or results of operations is uncertain. To date, other than prioritizing development on COVID-19 therapeutics over non-COVID related therapeutics, the Company has not experienced any significant external changes in our business that has had a significant negative impact on its consolidated statements of operations or cash flows.
7
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
Mergers
2020 Merger with ANA
On December 31, 2020, the Company acquired
2019 Merger with Gemphire
On July 24, 2019, Gemphire and NeuroBo Pharmaceuticals, Inc. (“Private NeuroBo”) entered into a definitive agreement, which was amended on October 29, 2019 (the “2019 Merger Agreement”). The merger closed on December 30, 2019, whereby Private NeuroBo merged with a wholly-owned subsidiary of the Company in an all-stock transaction (the “2019 Merger”).
Basis of presentation and consolidation principles
The accompanying condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The condensed consolidated financial statements may not include all disclosures required by GAAP; however, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the fiscal year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K filed with the SEC on April 15, 2021. The condensed consolidated balance sheet as of December 31, 2020 was derived from the audited financial statements.
In the opinion of management, all adjustments, consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, have been made. The results of operations for the interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods.
The condensed consolidated financial statements of the Company include a South Korean subsidiary, NeuroBo Co., LTD., which is fully owned by the Company. All significant intercompany accounts and transactions have been eliminated in the preparation of the financial statements.
Going Concern
From its inception through September 30, 2021, the Company has devoted substantially all of its efforts to drug discovery and development and conducting clinical trials. The Company has a limited operating history and the sales and income potential of the Company's business and market are unproven. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company's cost structure. As of September 30, 2021, the Company had $
8
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
To date, the Company has raised capital principally through the registered offerings and private placements of common stock, warrants and redeemable convertible preferred stock as well as via the issuance of convertible notes. On April 13, 2020, the Company entered into a Securities Purchase Agreement, pursuant to which the Company issued and sold shares of the Company’s common stock in a registered offering (the “ April 2020 Registered Offering”) which resulted in gross proceeds of $
The determination as to whether the Company can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company expects to continue to incur net losses and negative cash flows from operations into the foreseeable future. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company's cost structure. The Company has incurred net losses since inception and has relied on its ability to fund its operations through debt and equity financings. These conditions raise substantial doubt about the Company's ability to continue as a going concern. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company's assets and the satisfaction of liabilities in the normal course of business.
The Company believes that its existing cash will be sufficient to fund its operations into the fourth quarter of 2022. The Company plans to continue to fund its operations and capital funding needs through a combination of equity offerings, debt financings, or other sources, potentially including collaborations, licenses and other similar arrangements. There can be no assurance that the Company will be able to obtain any sources of financing on acceptable terms, or at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company's stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company's ability to conduct its business.
2. Summary of Significant Accounting Policies
Use of estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company's condensed consolidated financial statements relate to accrued expenses and the fair value of stock-based compensation and warrant issuances. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgements about the carrying values of assets and liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash. The Company’s cash is principally held by one financial institution in the United States. Amounts on deposit may at times exceed federally insured limits. Management believes that the financial institution is financially sound, and accordingly, minimal credit risk exists with respect to the financial institution. As of September 30, 2021, the Company had deposits in excess of federally insured amounts by $
9
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
Segment Information
Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in
Fair Value of Financial Instruments
The Company’s financial instruments include principally cash, prepaid, other assets, right of use assets, accounts payable, accrued liabilities and warrants. The carrying amounts of prepaid expenses, other assets, accounts payable, and accrued liabilities are reasonable estimates of their fair value because of the short maturity of these items.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related costs, including salaries and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include legal fees related to intellectual property and corporate matters and professional fees for accounting and other services.
Research and Development Costs
Research and development costs are charged to expense as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including clinical trial costs, manufacturing costs for both clinical and pre-clinical materials as well as other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received, rather than when payment is made, in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development.
Income Taxes
The Company utilizes the liability method of accounting for income taxes as required by ASC 740, Income Taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and the tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. Currently, there is
Stock-Based Compensation
The Company accounts for stock-based compensation in accordance with the provisions of ASC 718, Compensation — Stock Compensation (“ASC 718”). Accordingly, compensation costs related to equity instruments granted are recognized at the grant-date fair value. The Company records forfeitures when they occur. Stock-based compensation arrangements to non-employees are accounted for in accordance with the applicable provisions of ASC 718 using a fair value approach.
Leases
On July 1, 2019, the Company adopted Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842). The Company assesses its contracts at inception to determine whether the contract contains a lease, including evaluation of
10
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
whether the contract conveys the right to control an explicitly or implicitly identified asset for a period of time. The Company has recognized right-of-use assets and lease liabilities that represent the net present value of future operating lease payments utilizing a discount rate corresponding to the Company’s incremental borrowing rate and amortized over the remaining terms of the leases. For operating leases of a short-term nature, i.e., those with a term of less than twelve months, the Company recognizes lease payments as an expense on a straight-line basis over the remaining lease term.
Property and Equipment
Property and equipment is recorded at cost and reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line method. The estimated useful life for property and equipment ranges from
Foreign Currency Translation
The foreign subsidiary uses the local currency as the functional currency. The Company translates the assets and liabilities of its foreign operation into U.S. dollars based on the rates of exchange in effect as of the balance sheet date. Expenses are translated into U.S. dollars using average exchange rates for each period. The resulting adjustments from the translation process are included in accumulated other comprehensive loss in the accompanying condensed consolidated balance sheets.
Certain transactions of the Company are settled in foreign currency and are thus translated to U.S. dollars at the rate of exchange in effect at the end of each month. Gains and losses resulting from the translation are included in other income or expense in the accompanying condensed consolidated statements of operations and comprehensive loss.
Patent Costs
Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are included in general and administrative expenses.
Comprehensive Loss
Comprehensive loss is comprised of net loss and other comprehensive income or loss. Comprehensive loss includes net loss as well as other changes in stockholders' equity that result from transactions and economic events other than those with stockholders. Comprehensive loss currently consists of net loss and changes in foreign currency translation adjustments.
Recent Accounting Pronouncements Adopted
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB") or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption.
In December 2019, FASB issued ASU No. 2019-12, Income Taxes (Topic 740) which amends the existing guidance relating to the accounting for income taxes. This ASU is intended to simplify the accounting for income taxes by removing certain exceptions to the general principles of accounting for income taxes and to improve the consistent
11
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
application of GAAP for other areas of accounting for income taxes by clarifying and amending existing guidance. The ASU is effective for fiscal years beginning after December 15, 2020. The Company adopted this new guidance on January 1, 2021 and the adoption did not have a material impact on the Company’s condensed consolidated financial statements.
In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which, among other things, provides guidance on how to account for contracts on an entity’s own equity. This ASU eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, this ASU modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted earnings per share computation. The amendments in this ASU are effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The Company adopted this new guidance on January 1, 2021 and the adoption did not have a material impact on the Company’s condensed consolidated financial statements.
Recent Accounting Pronouncements Not Yet Adopted
In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses”. The ASU sets forth a “current expected credit loss” (CECL) model which requires the Company to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost and applies to some off-balance sheet credit exposures. This ASU is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, with early adoption permitted. Recently, the FASB issued the final ASU to delay adoption for smaller reporting companies to calendar year 2023. The Company is currently assessing the impact of the adoption of this ASU on its condensed consolidated financial statements.
3. Balance Sheet Detail (in thousands)
Property and Equipment
Property and equipment consist of the following:
September 30, | December 31, | |||||||
2021 | 2020 | |||||||
Research and development equipment | $ | | $ | | ||||
Office equipment | | | ||||||
Total property and equipment | | | ||||||
Less accumulated depreciation | ( | ( | ||||||
Property and equipment, net | $ | | $ | | ||||
Depreciation expense was $
12
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
Accrued liabilities
Accrued liabilities consist of the following as of:
| September 30, | December 31, |
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2021 | 2020 |
| |||||
External research and development expenses | $ | | $ | | |||
Payroll related |
| |
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Professional services | | | |||||
Other |
| |
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Total | $ | | $ | | |||
4. Merger Related Agreements
ANA Merger Milestone Payments
Pursuant to the 2020 Merger Agreement, following the closing of the 2020 Merger, the Company is obligated to pay milestone payments (each, a “Milestone Payment”) to certain persons identified in the 2020 Merger Agreement (each a “Stakeholder” and collectively, the “Stakeholders”) in the form, time and manner as set forth in the 2020 Merger Agreement, upon the achievement of the following milestone events set forth below by the Company or any of its affiliates (each, a “Milestone Event”):
Milestone Event | Milestone Payment | |||||
First receipt of Marketing Approval (as defined in the 2020 Merger Agreement) from the FDA for any Niclosamide Product (as defined in the 2020 Merger Agreement) | $ | |||||
Sales Milestones: | ||||||
Milestone Event – Worldwide Cumulative Net Sales of a Niclosamide Product | ||||||
equal to or greater than: | Milestone Payment | |||||
$ | $ | $ | ||||
$ | $ | |||||
$ | $ | |||||
$ | $ | 72.0 million |
In connection with the
Merger, the Company assumed a license agreement (the “YourChoice Agreement”) between ANA and YourChoice Therapeutics, Inc. (“YourChoice”).YourChoice granted to ANA, during the term of the YourChoice Agreement, an exclusive, worldwide, fee-bearing license derived from the licensed intellectual property throughout the world. As further discussed in Note 5, pursuant to the YourChoice Agreement, the Company is obligated to pay Milestone Payments to YourChoice.Additionally, pursuant to the 2020 Merger Agreement, the Company is obligated to pay a royalty of two and a half percent (
13
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
payment, a “Royalty Payment”) to the Stakeholders in the form, time and manner as set forth in the 2020 Merger Agreement, following the first commercial sale of each Niclosamide Product (as defined in the 2020 Merger Agreement) on a country-by-country and Niclosamide Product-by-Niclosamide Product basis.
As of September 30, 2021,
Gemphire Contingent Value Rights Agreement.
On December 30, 2019, in connection with the 2019 Merger, Gemphire entered into the Contingent Value Rights Agreement (the “CVR Agreement”) with Grand Rapids Holders’ Representative, LLC, as representative of Gemphire’s stockholders prior to the 2019 Merger (the “Holders’ Representative”), and Computershare Inc. and Computershare Trust Company, N.A. as the rights agents (collectively, the “Rights Agent”). Under the CVR Agreement, which NeuroBo assumed in connection with the 2019 Merger, the holders of Gemphire shares at the time of the 2019 Merger (collectively, the “CVR Holders”) were entitled to receive
On March 23, 2021, NeuroBo, the Holders’ Representative, and the Rights Agent entered into the First Amendment to Contingent Value Rights Agreement (the “CVR Amendment”) to amend the CVR Agreement. Pursuant to the CVR Amendment, (i) the CVR Holders will continue to have the right to receive
As of the September 30, 2021,
5. Commitments and Contingencies (in thousands)
Operating Leases
Boston Lease
On May 14, 2021, the Company entered into a non-cancelable operating lease for its corporate headquarters located in Boston Massachusetts. The agreement, effective August 1, 2021, has a
Prior to May 2021, the Company entered a non-cancelable operating lease for its corporate headquarters effective February 1, 2021. The lease had a
14
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
September 30, 2020, expense under the New Boston Lease and Boston Lease in the aggregate was $
Lease in Korea:
In May 2019, the Company entered a non-cancelable operating lease for its new facility in Korea (the “Korea Lease”). The initial lease term is
The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the consolidated balance sheet as of September 30, 2021 (in thousands):
As of | ||||
September 30, | ||||
2021 (period October 1 to December 31) | $ | | ||
2022 | | |||
2023 | | |||
2024 | | |||
Total lease payments | | |||
Less effect of discounting | ( | |||
Total | | |||
Short-term portion | ( | |||
Long-term portion | $ | | ||
Xiehecheng Cultivation Service Agreement
On September 1, 2018 and as amended on October 1, 2020, the Company entered into a cultivation service agreement with Xiehecheng Chinese Herm Limited Corporation for the cultivation of two plants used to manufacture the Company's clinical assets.
As of September 30, 2021, future minimum payments under the agreement, which is cancellable annually at the end of each research year, are as follows (in thousands):
December 31, | ||||
2021 (October 1 to December 31) | $ | | ||
2022 | | |||
$ | | |||
15
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
YourChoice License Agreement
As described in Note 4, in connection with 2020 Merger, the Company assumed the YourChoice License Agreement. The fees due under the YourChoice Agreement include royalty payments of
As of September 30, 2021, there was sufficient uncertainty with regard to both the outcome of the clinical trials and the ability to obtain sufficient funding to support any of the cash milestone payments under the YourChoice Agreement, and as such, no liabilities were recorded related to the YourChoice Agreement.
Pfizer License Agreement
Upon the close of the 2019 Merger, the exclusive license agreement with Pfizer, Inc. (“Pfizer”) for the clinical product candidate Gemcabene (the “Pfizer Agreement”) was assumed by the Company. Under the Pfizer Agreement, in exchange for this worldwide exclusive right and license to certain patent rights to make, use, sell, offer for sale and import the clinical product Gemcabene, the Company has agreed to certain milestone and royalty payments on future sales.
The Company agreed to make milestone payments totaling up to $
The Company also agreed to pay Pfizer tiered royalties on a country-by-country basis based upon the annual amount of net sales, as specified in the Pfizer Agreement, until the later of: (a)
As of September 30, 2021 and December 31, 2020, there was sufficient uncertainty with regard to both the outcome of the clinical trials and the ability to obtain sufficient funding to support any of the cash milestone payments, and as such, no liabilities were recorded related to the Pfizer Agreement.
Contingencies
From time to time, the Company may be subject to various claims and suits arising in the ordinary course of business. The Company does not expect that the resolution of these matters will have a material adverse effect on its financial position or results of operations.
16
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
6. License and Collaboration Agreement
Beijing SL License and Collaboration Agreement
Upon the close of the 2019 Merger, the License and Collaboration Agreement (the “Beijing SL Agreement”) with Beijing SL Pharmaceutical Co., Ltd. (“Beijing SL”) was assumed by the Company, pursuant to which the Company granted Beijing SL an exclusive royalty-bearing license to research, develop, manufacture and commercialize pharmaceutical products comprising, as an active ingredient, Gemcabene in mainland China, Hong Kong, Macau and Taiwan. The terms of the Beijing SL Agreement include payments based upon achievement of milestones and royalties on net product sales. Under the Beijing SL Agreement, the Company has variable consideration in the form of milestone payments. As of September 30, 2021,
7. Stockholders’ Equity
2021 Private Placement
On January 21, 2021, the Company closed on a Securities Purchase Agreement (the “2021 Purchase Agreement”) with certain institutional and accredited investors, pursuant to which the Company, in a private placement (“2021 Private Placement”), agreed to issue and sell an aggregate of
Issuance costs in connection with the 2021 Private Placement were $
Warrants
The following warrants were outstanding as of September 30, 2021 and December 31, 2020:
Exercise Price | Number Outstanding | Expiration Date | Number Exercisable | |||||||||
$ | 186.75 | July 2028 | ||||||||||
$ | 260.00 | March 2022 | ||||||||||
$ | 12.50 | April 2025 | ||||||||||
Total outstanding December 31, 2020 | ||||||||||||
$ | $6.03 | July 2026 | — | |||||||||
Total outstanding September 30, 2021 | ||||||||||||
17
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
8. Stock-based Compensation
Stock-based compensation expense was included in general and administrative and research and development costs as follows in the accompanying statements of comprehensive loss (in thousands):
Three Months Ended | Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
2021 |
| 2020 |
| 2021 |
| 2020 | |||||||
Research and development | $ | — | $ | — | $ | — | $ | | |||||
General and administrative | | | | ||||||||||
Total stock-based compensation | $ | | $ | $ | | $ | |
Stock Options
2019 and 2018 Stock Plans
In December 2018, Private NeuroBo adopted the NeuroBo Pharmaceuticals, Inc. 2018 Stock Plan (the "2018 Plan") and in December 2019 in connection with the 2019 Merger, the Company adopted the 2019 Equity Incentive Plan (the “2019 Plan”). 2018 Plan options to purchase Private NeuroBo common stock outstanding as of immediately prior to the 2019 Merger were assumed by the Company upon the 2019 Merger and became options to purchase the Company’s common stock, as adjusted by the exchange ratio in effect for the 2019 Merger. The 2018 Plan and the 2019 Plan provide for the grant of stock options, restricted stock and other equity awards of the Company's common stock to employees, officers, consultants, and directors. Options expire within a period of not more than
The following table summarizes the Company’s activity related to its stock options for the nine months ended September 30, 2021 and 2020:
Nine Months Ended | |||||
September 30, | |||||
2021 | 2020 | ||||
Outstanding on January 1 | |||||
Granted | |||||
Exercised | ( | ( | |||
Forfeited/Cancelled | ( | ( | |||
Outstanding on September 30 |
During the three and nine month periods ended September 30, 2021,
The Company measures the fair value of stock options with service-based and performance-based vesting criteria to employees, consultants and directors on the date of grant using the Black-Scholes option pricing model. The Company does not have history to support a calculation of volatility and expected term. As such, the Company has used a weighted-average volatility considering the volatilities of several guideline companies.
For purposes of identifying similar entities, the Company considered characteristics such as industry, length of trading
18
NeuroBo Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
history, and stage of life cycle. The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. The average expected life of the options was determined based on the mid-point between the vesting date and the end of the contractual term according to the “simplified method” as described in Staff Accounting Bulletin 110. The risk-free interest rate is determined by reference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant. The Company records forfeitures when they occur.
The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows:
Three Months Ended | Nine Months Ended | ||||||||||
September 30, | September 30, | ||||||||||
| 2021 | 2020 |
| 2021 |
| 2020 | |||||