UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
For the quarterly period ended
or
For the transition period ended from ________ to ________
Commission File Number:
(Exact name of registrant as specified in its charter)
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incorporation or organization) |
(Address of principal executive offices)
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Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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Large accelerated filer | ¨ | Accelerated filer | ¨ | |
x | Smaller reporting company | |||
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| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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As of August 6, 2021, there were
TABLE OF CONTENTS
PART I – FINANCIAL INFORMATION | ||
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Management’s Discussion and Analysis of Financial Condition and Results of Operations. | 20 | |
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PART II – OTHER INFORMATION | ||
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Unregistered Sales of Equity Securities and Use of Proceeds. | 29 | |
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PART I - FINANCIAL INFORMATION
Item 1. Unaudited Condensed Consolidated Financial Statements
SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, |
| December 31, | |||
2021 | 2020 | |||||
(Unaudited) | ||||||
ASSETS |
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Current assets: |
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Cash | $ | | $ | | ||
Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Total assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Current liabilities |
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Accounts payable and accrued expenses | $ | | $ | | ||
Convertible notes payable, net |
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Common stock warrant liability | | | ||||
Total current liabilities |
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COMMITMENTS AND CONTINGENCIES (NOTE 8) |
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Stockholders’ equity (deficit): |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Note receivable |
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Accumulated deficit |
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Accumulated other comprehensive loss |
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Total stockholders’ equity (deficit) |
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Total liabilities and stockholders’ equity (deficit) | $ | | $ | |
See accompanying notes to condensed consolidated financial statements.
1
SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
| Three Months Ended June 30, |
| Six Months Ended June 30, | |||||||||
2021 |
| 2020 | 2021 |
| 2020 | |||||||
Revenues | $ | | $ | | $ | | $ | | ||||
Operating expenses: |
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General and administrative |
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Research and development |
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Total operating expenses |
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Loss from operations |
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Other expense: |
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Interest expense |
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Change in fair value of common stock warrant liability | ( | — | ( | — | ||||||||
Total other expense | ( | ( | ( | ( | ||||||||
Net loss |
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Comprehensive income (loss): |
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Foreign currency translation adjustment |
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Total comprehensive loss |
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Net loss per common share: |
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Basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Weighted-average common shares outstanding: |
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Basic and diluted |
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See accompanying notes to condensed consolidated financial statements.
2
SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
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| Accumulated Other |
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Common Stock | Additional | Note | Accumulated | Comprehensive | Total Stockholders’ | |||||||||||||||
Shares |
| Amount | Paid-in Capital | Receivable | Deficit | Loss | Equity (Deficit) | |||||||||||||
Balances as of March 31, 2021 | | $ | | $ | | $ | ( | $ | ( | $ | ( | $ | | |||||||
Issuance of common stock for acquisition of in-process research and development | | | | — | — | — | | |||||||||||||
Issuance of common stock on achievement of research and development milestones | | | | — | — | — | | |||||||||||||
Common stock warrant liability | — | — | ( | — | — | — | ( | |||||||||||||
Stock-based compensation expense |
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Foreign currency translation adjustment |
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Net loss |
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Balances as of June 30, 2021 |
| | $ | | $ | | $ | ( | $ | ( | $ | ( | $ | ( |
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| Accumulated Other |
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Common Stock | Additional | Note | Accumulated | Comprehensive | Total Stockholders’ | |||||||||||||||
Shares |
| Amount | Paid-in Capital | Receivable | Deficit | Loss | Equity (Deficit) | |||||||||||||
Balances as of December 31, 2020 | | $ | | $ | | $ | ( | $ | ( | $ | ( | $ | ( | |||||||
Issuance of common stock - net of issuance costs of $ | | | | — | — | — | | |||||||||||||
Issuance of common stock for acquisition of in-process research and development | | | | — | — | — | | |||||||||||||
Issuance of common stock on achievement of research and development milestones |
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Common stock warrant liability | — | — | ( | — | — | — | ( | |||||||||||||
Stock-based compensation expense |
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Foreign currency translation adjustment |
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Net loss |
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Balances as of June 30, 2021 |
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See accompanying notes to condensed consolidated financial statements.
3
SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
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Common Stock | Additional | Note | Accumulated | Comprehensive | Total Stockholders’ | |||||||||||||||
Shares |
| Amount | Paid-in Capital | Receivable | Deficit | Loss | Equity (Deficit) | |||||||||||||
Balances as of March 31, 2020 | | $ | | $ | | $ | — | $ | ( | $ | ( | $ | ( | |||||||
Issuance of common stock for acquired in-process research and development | | | | — | — | — | | |||||||||||||
Issuance of warrants with Convertible Notes | — | — | | — | — | — | | |||||||||||||
Issuance of warrants | — | — | | — | — | — | | |||||||||||||
Issuance of warrants relating to note receivable | — | — | | ( | — | — | — | |||||||||||||
Stock-based compensation expense |
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Foreign currency translation adjustment |
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Net loss |
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Balances as of June 30, 2020 |
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| Accumulated Other |
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Common Stock | Additional | Note | Accumulated | Comprehensive | Total Stockholders’ | |||||||||||||||
Shares |
| Amount | Paid-in Capital | Receivable | Deficit | Loss | Equity (Deficit) | |||||||||||||
Balances as of December 31, 2019 | | $ | | $ | | $ | — | $ | ( | $ | ( | $ | ( | |||||||
Issuance of common stock and warrants for acquisition of in-process research and development | | | | — | — | — | | |||||||||||||
Issuance of warrants with Convertible Notes | — | — | | — | — | — | | |||||||||||||
Issuance of warrants - net of issuance costs of $ | | — | — | — | | |||||||||||||||
Issuance of warrants relating to note receivable |
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Stock-based compensation expense | — | — | | — | — | — | | |||||||||||||
Foreign currency translation adjustment |
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Net loss |
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Balances as of June 30, 2020 |
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See accompanying notes to condensed consolidated financial statements.
4
SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| Six Months Ended June 30, | |||||
2021 | 2020 | |||||
Cash flows from operating activities: |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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Issuance of common stock and warrants for acquisition of in-process research and development | | | ||||
Issuance of common stock on achievement of research and development milestones | | | ||||
Change in fair value of common stock warrant liability | | | ||||
Stock-based compensation |
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Amortization of debt issuance costs and debt discount |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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Accounts payable and accrued expenses |
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Net cash used in operating activities |
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Cash flows from financing activities: |
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Gross proceeds from issuance of common stock |
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Issuance costs related to the issuance of common stock |
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Gross proceeds from issuance of Convertible Notes and warrants | | | ||||
Issuance costs related to the issuance of Convertible Notes and warrants | | ( | ||||
Gross proceeds from issuance of units and warrants |
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Issuance costs related to the issuance of units and warrants |
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Payment of deferred offering costs |
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Net cash provided by financing activities |
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Effects of changes in foreign currency exchange rates on cash |
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Net increase in cash |
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Cash, beginning of period |
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Cash, end of period | $ | | $ | | ||
Supplemental disclosure of cash flow information: |
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Non-cash financing activity: |
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Purchases of property and equipment in accounts payable and accrued expenses | $ | | $ | | ||
Offering costs in accounts payable and accrued expenses |
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Deferred financing costs on convertible notes payable in accounts payable and accrued expenses |
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Purchase price for acquisitions payable in cash in accounts payable and accrued expenses | | | ||||
Convertible notes issued in lieu of cash |
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W Warrants issued in lieu of cash |
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See accompanying notes to condensed consolidated financial statements.
5
SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. Organization and Description of the Business
Nature of Operations
Scopus BioPharma Inc. (“Scopus”) and its subsidiary, Vital Spark, Inc. (“VSI”), are headquartered in New York. Its other subsidiaries, Olimmune Inc. (“Olimmune”) and Scopus BioPharma Israel Ltd. (“SBI”), are headquartered in Los Angeles, California and Jerusalem, Israel, respectively. Scopus, VSI, Olimmune, and SBI are collectively referred to as the “Company.” The Company is a clinical-stage biopharmaceutical company developing transformational therapeutics for serious diseases with significant unmet medical needs.
Going Concern
The provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements - Going Concern (ASC 205-40) requires management to assess an entity’s ability to continue as a going concern within one year of the date the financial statements are issued. In each reporting period (including interim periods), an entity is required to assess conditions known and reasonably knowable as of the financial statement issuance date to determine whether it is probable an entity will not meet its financial obligations within one year from the financial statement issuance date. Substantial doubt about an entity’s ability to continue as a going concern exists when conditions and events, considered in the aggregate, indicate it is probable the entity will be unable to meet its financial obligations as they become due within one year after the date the financial statements are issued.
The Company is an early-stage company and has not generated revenues to date. As such, the Company is subject to all of the risks associated with early-stage companies. Since inception, the Company has incurred losses and negative cash flows from operating activities which have been funded from the issuance of convertible notes, common stock, and warrants (sees Notes 3, 6 and 9). The Company does not expect to generate positive cash flows from operating activities in the near future, if at all, until such time it completes the development of its drug candidates, including obtaining regulatory approvals, and anticipates incurring operating losses for the foreseeable future.
The Company incurred net losses of $
The Company’s ability to fund its operations is dependent upon management’s plans, which include raising capital through issuances of debt and equity securities, securing research and development grants, generating sufficient revenues, and controlling the Company’s expenses. A failure to raise sufficient financing, generate sufficient revenues, or control expenses, among other factors, will adversely impact the Company’s ability to meet its financial obligations as they become due and payable and to achieve its intended business objectives.
This evaluation is further impacted by an ongoing pandemic related to the COVID-19 coronavirus. While uncertain at this time, the extent of its impacts depends largely on the spread and duration of the outbreak, and may result in disruptions to capital raises, employees, and vendors which could result in negative impacts to operational and financial results.
Accordingly, management has concluded this raises substantial doubt of the Company’s ability to continue as a going concern within one year after the date the condensed consolidated financial statements are issued.
6
SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1.Organization and Description of the Business (Continued)
Going Concern (continued)
The Company’s condensed consolidated financial statements have been prepared on a going concern basis which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities should the Company be unable to continue as a going concern.
COVID-19 Pandemic
The Company is continually monitoring the impact of the global pandemic on its business, especially since the Company conducts activities in multiple locations, both in and outside of the United States. These locations are New York City and Los Angeles in the United States and Jerusalem and Tel Aviv in Israel. At various times since the onset of the global pandemic, these locations have been severely affected by COVID-19 and, as a result, have been subject to various requirements to stay at home and self-quarantine, as well as constraints on mobility and travel, especially international travel.
In many locations, the primary focus of healthcare providers and hospitals has been to combat the virus. While the Company continues to advance its development programs, the Company is also continually assessing the impact of the global pandemic on its product development efforts, including any impact on the timing and/or costs for its clinical trials, investigational new drug application (“IND”) enabling work, and other research and development activities. There is no certainty as to the length and severity of societal disruption caused by COVID-19. Consequently, the Company does not have sufficient visibility to predict the impact of the global pandemic on its operations and overall business, including delays in the progress of its planned pre-clinical work and clinical trials, or by limiting its ability to recruit physicians or clinicians to run its clinical trials, enroll patients or conduct follow-up assessments in its clinical trials. Further, the business or operations of its strategic partners and other third parties with whom the Company conducts business may also be adversely affected by the global pandemic. The Company continues to monitor the impact of the global pandemic, including regularly reevaluating the timing of its research and development and clinical milestones. In light of the more restrictive constraints on international travel, the Company continues to adjust program emphasis and prioritization. Until the Company is able to gain greater visibility as to the impact of the global pandemic, the Company intends to commit greater resources to its existing and future programs in the United States and is slowing investment in program development outside the United States.
2. Summary of Significant Accounting Policies
The Company’s accounting policies are the same as those described in Note 2 to the Company’s Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the U.S. Securities and Exchange Commission (“SEC”) on March 29, 2021, and as amended on April 29, 2021 (collectively, “the 2020 10-K”).
The Company is an “emerging growth company”, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has irrevocably elected to avail itself of this exemption from new or revised accounting standards, and, therefore, will not be subject to the same new or revised accounting standards as public companies that are not emerging growth companies.
The Company has reviewed recent accounting pronouncements and concluded they are either not applicable to the business or no material effect is expected on the condensed consolidated financial statements as a result of future adoption.
7
SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
2. Summary of Significant Accounting Policies (Continued)
Basis of Presentation and Principles of Consolidation
The condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to such rules and regulations. In management’s opinion, the accompanying statements reflect adjustments necessary to present fairly the financial position, results of operations, and cash flows for those periods indicated, and contain adequate disclosure to make the information presented not misleading. Adjustments included herein are of a normal, recurring nature unless otherwise disclosed in the footnotes. All significant intercompany transactions have been eliminated upon consolidation. Certain prior period amounts have been reclassified to conform to current period presentation.
The condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2020 included in the Company’s 2020 10-K. The accompanying condensed consolidated balance sheet at December 31, 2020 has been derived from the audited balance sheet at December 31, 2020 contained in the Company’s 2020 10-K. Results of operations for interim periods are not necessarily indicative of the results of operations for a full year.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Significant estimates in these condensed consolidated financial statements include those related to the fair value of common stock, warrants, stock-based compensation, the provision or benefit for income taxes and the corresponding valuation allowance on deferred tax assets, and probability of meeting certain milestones. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company evaluates its estimates, judgments, and methodologies. The Company bases its estimates on historical experience and on various other assumptions believed to be reasonable. Due to the inherent uncertainty involved in making estimates, actual results could differ materially from those estimates.
Offering Costs
Offering costs totaling $
Fair Value Measurement
Certain assets and liabilities are carried at fair value in accordance with U.S. GAAP. Fair value is defined as the price which would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants at the measurement date. A three-tier fair value hierarchy which prioritizes the inputs used in the valuation methodologies, are as follows:
Level 1 | Valuations based on quoted prices for identical assets and liabilities in active markets. |
Level 2 | Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets which are not active, or other inputs observable or can be corroborated by observable market data. |
Level 3 | Valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment. |
8
SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
2. Summary of Significant Accounting Policies (Continued)
Fair Value Measurement (Continued)
As of June 30, 2021 and December 31, 2020, the carrying amounts of the Company’s cash, accounts payable and accrued expenses, and convertible notes payable approximate their respective fair value due to the short-term nature of these instruments.
The common stock warrant liability is recorded at fair value on a recurring basis and is considered a Level 3 liability. The fair value of the common stock warrant liability is included in “Common stock warrant liability” in current liabilities on the condensed consolidated balance sheets, as the warrants become exercisable within one year.
Net Loss Per Share
Basic net loss per common share attributable to common shareholders is calculated by dividing net loss attributable to common shareholders by the weighted average number of common shares outstanding for the relevant period. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as dilutive net loss per share as the inclusion of the weighted-average number of all potential dilutive common shares which consist of convertible debt, stock options and warrants, would be anti-dilutive.
The following table presents the weighted-average, potentially dilutive shares that were excluded from the computation of diluted net (loss) per share of common stock attributable to common stockholders, because their effect was anti-dilutive:
Three months ended June 30, | Six months ended June 30, | |||||||
| 2021 |
| 2020 |
| 2021 |
| 2020 | |
Warrants | | | | | ||||
Convertible Notes (if converted) | | | | | ||||
Stock options | | | | | ||||
Contingent consideration in common stock |
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Total |
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3. Public Offering
On February 10, 2021, the Company completed a follow-on public offering of
4. Acquisitions
On June 25, 2021, the Company completed the acquisition of Olimmune, a developer of oligonucleotide immunotherapies for the treatment of multiple cancers. Olimmune owned the exclusive right to negotiate
9
SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
4. Acquisitions (Continued)
On June 10, 2020, the Company completed the acquisition of Bioscience Oncology Pty. Ltd. (“Bioscience Oncology”), a pre-clinical biopharmaceutical company which held a single asset, the exclusive right to negotiate a license agreement for CpG-STAT3siRNA, or CO-sTiRNATM, with City of Hope (see Note 7). The transaction was accounted for as an asset acquisition as the purchase primarily related to a single asset. The aggregate upfront expense, including the upfront license fees paid to City of Hope totaled approximately $
5. Accounts payable and accrued expenses
Accounts payable and accrued expenses consist of the following as of:
| June 30, |
| December 31, | |||
2021 | 2020 | |||||
Professional fees | $ | | $ | | ||
Research and development expenses | | | ||||
Management service fees and expenses |
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Convertible Notes interest payable | | | ||||
Other accounts payable and accrued expenses |
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Total accounts payable and accrued expenses | $ | | $ | |
Amounts due to related parties included in accounts payable and accrued expenses totaled $
6. Debt
In April 2020, the Company amended the terms of its December 2019 Private Placement (see Note 9) to issue convertible promissory notes (“Convertible Notes”) with W Warrants (“Convertible Notes Private Placement”) in an initial principal amount of up to $
Between June 2020 and September 2020, the Company issued an aggregate initial principal amount of $
Between February 2020 and June 2020, the Company issued convertible notes on identical terms to those of the Convertible Notes Private Placement to HCFP/Portfolio Services LLC (“Portfolio Services”) (see Note 9), investors and vendors, on a direct basis, in an aggregate initial principal amount of $
10
SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
6. Debt (Continued)
Investors who purchased W Warrants in the December 2019 Private Placement prior to the amendment of its terms were provided the option to surrender
The Convertible Notes principal amount of $
Balances related to the Convertible Notes included the following as of:
| June 30, |
| December 31, | |||
2021 | 2020 | |||||
Convertible Notes principal amount | $ | | | |||
Unamortized discount |
| ( |
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Deferred financing costs |
| ( |
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Convertible Notes payable, net | $ | | $ | |
Interest expense for the three and six months ended June 30, 2021 totaled $
7. Research and Development Agreements
Agreement Related to Intellectual Property Rights
In July 2017, VSI as “Licensee” entered into a Patent License Agreement (the “Patent License Agreement”) with The U.S. Department of Health and Human Services, as represented by the National Institute on Alcohol Abuse and Alcoholism (“NIAAA”) and the National Institute on Drug Abuse (“NIDA”) of the National Institutes of Health (“NIH”), (collectively “Licensor”). In the course of conducting biomedical and behavioral research, the Licensor developed inventions that may have commercial applicability. The Licensee acquired commercialization rights to certain inventions in order to develop processes, methods, or marketable products for public use and benefit.
Patent fee reimbursement under the Patent License Agreement was $
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SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
7. Research and Development Agreements (Continued)
Agreement Related to Intellectual Property Rights (Continued)
Pursuant to the terms of the Patent License Agreement, VSI is required to make minimum annual royalty payments on January 1 of each calendar year, which shall be credited against any earned royalties due for sales made in that year, throughout the term of the Patent License Agreement. For the three months ended June 30, 2021 and 2020, $
The Patent License Agreement also provides for payments from VSI to the Licensor upon the achievement of certain product development and regulatory clearance milestones, as well as royalty payments on net sales upon the commercialization of products developed utilizing the licensed patents. Through June 30, 2021, the Licensor has not achieved any milestones and therefore VSI has not made any milestone payments.
VSI is obligated to pay earned royalties based on a percentage of net sales, as defined in the Patent License Agreement, of licensed product throughout the term of the Patent License Agreement. Since April 18, 2017 (inception) through June 30, 2021, there have been
Cooperative Research and Development Agreement
Effective January 11, 2018, VSI signed a two-year Cooperative Research and Development Agreement (the “CRADA Agreement”) with the NIH for preclinical testing relating to the Patent License Agreement described above. Pursuant to the terms of the CRADA Agreement, each party will provide scientific staff and other support necessary to conduct the research and other activities described in the research plan. This agreement was subsequently amended to defer funding for year two subject to additional testing by NIH and approval of the results by VSI. On May 7, 2019, the Company made the first of
Total expenses incurred in connection with the CRADA Agreement for the three months ended June 30, 2021 and 2020 amounted to $
Memorandums of Understanding
Effective July 28, 2018, SBI entered into
The fees incurred in connection with these MOU’s for the three months ended June 30, 2021 and 2020 amounted to $
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SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
7. Research and Development Agreements (Continued)
Memorandums of Understanding (Continued)
Effective March 5, 2019, the Company entered in a license agreement with Yissum with respect to the results of the research relating to the combination of cannabidiol with approved anesthetics as a potential treatment for the management of pain. Under the license agreement, the Company is obligated to pay earned royalties based on a percentage of net sales, as defined in the license agreement, including net sales generated from sub-licensees. In addition, the Company will be obligated to make payments upon the achievement of certain clinical development and product approval milestones. From March 5, 2019 through June 30, 2021, there have been
Effective August 8, 2019, the Company entered into a second license agreement with Yissum with respect to the research results relating to the synthesis of novel cannabinoid dual-action compounds and novel chemical derivatives of cannabigerol and tetrahydrocannabivarin. Under this license agreement, the Company is required to pay earned royalties based upon a percentage of net sales at
CO-sTiRNA License Agreement and Sponsored Research Agreement
In June 2020, the Company entered into an exclusive, worldwide license agreement with City of Hope relating to CO-sTiRNA (the “CO-sTiRNA License Agreement”). In addition to the CO-sTiRNA License Agreement, the Company also entered into a Sponsored Research Agreement (the “SRA”) relating to on-going research and development activities in collaboration with City of Hope relating to CO-sTiRNA. The Company obtained the right to negotiate the CO-sTiRNA License Agreement with City of Hope as part of the Bioscience Oncology acquisition in June 2020. Under the terms of the CO-sTiRNA License Agreement, the Company is obligated to pay earned royalties based on a percentage of net sales, as defined in the CO-sTiRNA License Agreement, including net sales generated from sub-licensees. In addition, the Company is obligated to make payments in cash upon the achievement of certain clinical development and product approval milestones totaling $
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SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
7. Research and Development Agreements (Continued)
CO-sTiRNA License Agreement and Sponsored Research Agreement (Continued)
In March 2021, the Company paid to City of Hope approximately $
In May 2021, the Company received United States Food and Drug Administration (“FDA”) approval of its IND application related to CO-sTiRNA. Pursuant to the definitive agreement to acquire Bioscience Oncology, this approval satisfied a milestone that resulted in the issuance of approximately
Olimmune License Agreements
On June 25, 2021, the Company entered into
8. Commitments and Contingencies
Research and Development Agreements
The Company has entered into various research and development agreements which require the Company to provide certain funding and support. See Note 7 for further information regarding these agreements.
Legal Proceedings
Except as hereinafter set forth, the Company is not a party to any litigation. On April 7, 2021, a co-founder and former director of the Company, filed a Schedule 13D in which such former director claims sole beneficial ownership of certain shares. Such Schedule 13D sets forth that such former director has initiated litigation against the Company in the Delaware Court of Chancery with respect to ownership of shares of the Company’s common stock. The Company has moved to dismiss this lawsuit in its entirety. The Schedule 13D also provides that such former director has determined to vote against the future election of members of the Company’s board of directors. This litigation is still at an early stage and it is too early to assess potential liabilities, if any. Accordingly, the Company does not currently have any contingency reserves established for any potential litigation liabilities. Separate from the foregoing, the Company and such former director do not agree on numerous other matters, which creates the potential for additional litigation. Litigation is highly unpredictable and the costs of litigation, including legal fees and expenses, could be significant. Given the inherent uncertainties, the Company may become subject to liabilities, including monetary damages. Any such liabilities could have a material adverse impact on the Company’s business, financial position, results of operations and cash flows.
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SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
9. Stockholders’ Equity
Preferred Stock
The Company is authorized to issue
Common Stock
The Company is authorized to issue
The powers, preferences, and rights of the holders of the common stock are junior to the preferred stock and are subject to all the powers, rights, privileges, preferences, and priorities of the preferred stock. The holder of each share of common stock shall have the right to
Equity Units
On February 4, 2020, the Company offered up to
Warrants
During the six months ended June 30, 2021, no warrants were issued, exercised, or forfeited. As of June 30, 2021,
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SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
9. Stockholders’ Equity (Continued)
Common Stock Warrant Liability
At June 30, 2021, the Company had outstanding
The fair value of the common stock warrant liability at reclassification and as of June 30, 2021 was estimated using a Monte Carlo daily price simulation based on the market value of the underlying common stock at the measurement date. Inputs to the model at each date included:
| June 25, |
| June 30, |
| ||
2021 | 2021 | |||||
Price of underlying common stock | $ | | $ | |
| |
Expected dividend rate | | % | | % | ||
Expected term (years) |
| |
| | ||
Weighted-average expected stock price volatility |
| | % | | % | |
Risk-free interest rate |
| | % | | % |
Contingent Common Stock
As a result of the Company’s acquisition of Bioscience Oncology, the previous shareholders of Bioscience Oncology are eligible to receive remaining contingent consideration of up to approximately
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SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
10. Stock Options
Effective September 24, 2018, the Company approved the Scopus BioPharma Inc. 2018 Equity Incentive Plan (the “Plan”), and reserved
In addition, in connection with the Company’s follow-on offering (see Note 3), the Company granted options to purchase
There were no stock options granted during the three and six months ended June 30, 2020.
Price of underlying common stock |
| $ | | — | $ | |
Expected dividend rate |
| |||||
Expected term (years) |
| |||||
Weighted-average expected stock price volatility |
| |||||
Risk-free interest rate |
|
Stock option activity is summarized as follows for the six months ended June 30, 2021:
|
|
| Weighted-average | |||||
Weighted-average | Grant Date | |||||||
Options | Exercise Price | Fair Value | ||||||
Outstanding at December 31, 2020 | | $ | | $ | | |||
Granted | | | | |||||
Exercised |
| |
| |
| | ||
Forfeited |
| ( |
| |
| | ||
Outstanding at June 30, 2021 |
| | $ | | $ | | ||
|
|
| ||||||
Vested and exercisable at June 30, 2021 |
| | $ | | $ | | ||
Unvested at June 30, 2021 |
| | $ | | $ | |
Stock-based compensation associated with vesting options was $
11. Related Party Transactions
The Company has a management services agreement, as amended, with Portfolio Services, an affiliated entity, to provide management services to the Company including, without limitation, financial and accounting resources, general business development, corporate development, corporate governance, marketing strategy, strategic development and planning, coordination with service providers and other services as agreed upon between the parties. The Company pays Portfolio Services a monthly management services fee plus related expense reimbursement and provision of office space and facilities. The monthly management services fee is $
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SCOPUS BIOPHARMA INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
11. Related Party Transactions (Continued)
For the three and six months ended June 30, 2021, the Company incurred expenses of $
Pursuant to a management services agreement with Clil Medical Ltd. (“Clil”), an affiliate of a co-founder and former director of the company, such individual was obligated to provide executive and other management services to the Company. This management services agreement was terminated in June 2020 and, concurrently, such individual resigned as a director of the Company, but continued to serve in various other capacities for the Company and its subsidiaries. Subsequently, such individual submitted resignations to the Company and its subsidiaries. The Company and such individual do not agree on various matters, including obligations under the applicable management services agreement, both prior and subsequent to its termination. The Company did not incur expenses related to this management services agreement during the three and six months ended June 30, 2021. For the three and six months ended June 30, 2020, the Company incurred expenses of $
In January and February of 2020, HCFP/Direct Investments LLC (“Direct Investments”) advanced a total of $
In April 2020, one of the Company’s directors invested $
Related party amounts included in “Accounts payable and accrued expenses” in the accompanying condensed consolidated balance sheets were as follows:
| June 30, |
| December 31, | |||
2021 | 2020 | |||||
HCFP/Portfolio Services LLC | $ | | $ | | ||
Clil Medical Ltd. |
| |
| | ||
HCFP LLC |
| |