Item 9A. Controls and Procedures
ITEM 9A.
CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15(b) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, under the direction of the Chief Executive Officer and the principal financial officer, we
have evaluated our disclosure controls and procedures as of the end of the period covered by this Annual Report. Based on this evaluation, our Chief Executive Officer and principal financial officer have concluded that our disclosure controls
and procedures were effective as of the end of the period covered by this Annual Report.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting to provide reasonable assurance regarding the reliability of
our financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles. Internal control over financial reporting includes those policies and procedures that: (i)
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation
of financial statements in accordance with U.S. generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and Board; and (iii) provide reasonable
assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.
Our management, including our Chief Executive Officer and principal financial officer, recognizes that our internal control over financial reporting cannot prevent or detect
all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that
there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that
misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. The design of any system of controls is based in part on certain assumptions about the likelihood of future events,
and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Management, with the participation of the Chief Executive Officer and principal financial officer, assessed our internal control over financial reporting as of December 31,
2021, the end of our fiscal year. Management based its assessment on criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on that evaluation,
management has concluded that the Company’s internal control over financial reporting was effective as of December 31, 2021.
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Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d‑15(f) under the Exchange Act) that occurred during the quarter ended December 31,
2021 which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B.
OTHER INFORMATION
None.
ITEM 9C.
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
We will file a definitive Proxy Statement for our 2022 Annual Meeting of Stockholders (the “2022 Proxy Statement”) with the SEC, pursuant to Regulation 14A, not later than 120 days after the end
of our fiscal year. Accordingly, certain information required by Part III has been omitted under General Instruction G(3) to Form 10-K. Only those sections of the 2022 Proxy Statement that specifically address the items set forth herein are
incorporated by reference.
ITEM 10.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by Item 10 is hereby incorporated by reference to the sections of the 2022 Proxy Statement under the
captions “Board and Committee Information” and “Proposal No. 1 – Election of Directors,” “Executive Officers”.
ITEM 11.
EXECUTIVE COMPENSATION
The information required by Item 11 is hereby incorporated by reference to the sections of the 2022 Proxy Statement under the captions “Executive Compensation” and “Proposal No. 1 – Election of
Directors – Non-Employee Director Compensation.”
ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by Item 12 is hereby incorporated by reference to the sections of the 2022 Proxy Statement under the captions “Security Ownership of Certain Beneficial Owners and
Management” and “Securities Authorized for Issuance under Equity Compensation Plans.”
ITEM 13.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by Item 13 is hereby incorporated by reference to the sections of the 2022 Proxy Statement under the captions “Certain Relationships and Related-Party Transactions” and
“Board and Committee Information.”
ITEM 14.
PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by Item 14 is hereby incorporated by reference to the sections of the 2022 Proxy Statement under the caption “Proposal No. 2 – Ratification of Independent Registered
Public Accounting Firm.”
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PART IV
The following documents are filed as a part of this Annual Report on Form 10-K:
(a)
Financial Statements: The financial statements filed as part of this report are listed in Part II, Item 8.
(b)
Financial Statement Schedules: The schedules are either not applicable or the required information is presented in the consolidated financial statements or notes thereto.
(c)
Exhibits: The following exhibits are incorporated by reference or filed as part of this Annual Report on Form 10-K:
ITEM 15.
EXHIBITS, FINANCIAL STATEMENT SCHEDULES
EXHIBIT
NUMBER
DESCRIPTION OF DOCUMENT
2.1+
Agreement and Plan of Merger, dated as of June 17, 2020, by and among the Registrant, Razor Merger Sub, Inc. and Ocuphire Pharma, Inc. (incorporated by reference to Exhibit 2.1 to the Registrant’s Current
Report on Form 8-K, filed on June 19, 2020)..
2.2
First Amendment to Agreement and Plan of Merger and Reorganization, dated as of June 29, 2020, by and among Rexahn, Merger Sub and Ocuphire (incorporated by reference to Exhibit 2.1 to the Registrant’s
Current Report on Form 8-K , filed on July 1, 2020).
3.1
Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Appendix G to the Registrant’s Definitive Proxy Statement on Schedule 14A, filed on April 29, 2005).
3.2
Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on May 5,
2017).
3.3
Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on August 30,
2018).
3.4
Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on April 12,
2019).
3.5
Certificate of Amendment of Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on November 6, 2020).
3.6
Certificate of Amendment of Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed on November 6, 2020).
3.7
Second Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.3 to the Registrant’s Current Report on Form 8-K, filed on November 6, 2020).
4.1
Specimen Certificate for the Registrant’s Common Stock, par value $.0001 per share (incorporated by reference to Exhibit 4.3 to the Registrant’s Registration Statement on Form S-8 (File No. 333-129294),
filed on October 28, 2005).
4.2
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on November 6, 2015).
4.3
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on February 26, 2016).
4.4
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on September 14, 2016).
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4.5
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on June 7, 2017).
4.6
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on October 13, 2017).
4.7
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on October 19, 2018).
4.8
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on January 25, 2019).
4.9
Stockholders Agreement, dated as of April 10, 2018, among Ocuphire Pharma, Inc. and Stockholders as defined therein (incorporated by reference to Exhibit 4.9 to the Registrant’s Registration Statement on
Form S-4 (File No. 333-239702), filed on September 30, 2020).
4.10
Form of Series A/B Warrants (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on July 1, 2020).
4.11
Description of Securities (incorporated by reference to Exhibit 4.11 to the Registrant’s Annual Report on Form 10-K, filed on March 11, 2021).
4.12
Form of Warrant to purchase shares of common stock (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K/A, filed on June 7, 2021).
10.1*++
Amended and Restated Employment Agreement by and among the Company and Mina Sooch, effective as of November 5, 2020 (incorporated by reference to Exhibit 10.27 to the Registrant’s Registration Statement on
Form S-4 (File No. 333-239702), filed on September 30, 2020).
10.2*
Amended and Restated Employment Agreement by and among the Company and Bernhard Hoffmann, effective as of November 5, 2020 (incorporated by reference to Exhibit 10.29 to the Registrant’s Registration
Statement on Form S-4 (File No. 333-239702), filed on September 30, 2020).
10.3*
Form of Indemnification Agreement (incorporated by reference to Exhibit 10.30 to the Registrant’s Registration Statement on Form S-4 (File No. 333-239702), filed on September 30, 2020).
10.4++
Sublicense Agreement, dated as of January 21, 2020, by and between Ocuphire Pharma, Inc. and Apexian Pharmaceuticals, Inc (incorporated` by reference to Exhibit 10.31 to the Registrant’s Registration
Statement on Form S-4 (File No. 333-239702), filed on September 30, 2020).
10.4.1
First Amendment to Sublicense Agreement, dated as of June 4, 2020, by and between Apexian Pharmaceuticals, Inc. and Ocuphire Pharma, Inc (incorporated by reference to Exhibit 10.32 to the Registrant’s
Registration Statement on Form S-4 (File No. 333-239702), filed on September 30, 2020).
10.5
Lease Agreement, dated as of May 19, 2019, by and between Ocuphire Pharma, Inc. and Duke & Duke, LP (incorporated by reference to Exhibit 10.33 to the Registrant’s Registration Statement on Form S-4
(File No. 333-239702), filed on September 30, 2020).
10.5.1
First Amendment to Lease Agreement, dated as of October 29, 2019, by and between Ocuphire Pharma, Inc. and Duke & Duke, LP (incorporated by reference to Exhibit 10.34 to the Registrant’s Registration
Statement on Form S-4 (File No. 333-239702), filed on September 30, 2020).
10.5.2
Second Lease Amendment, dated as of November 17, 2020, by and between the Company and Duke & Duke (incorporated by reference
to Exhibit 10.43 to the Registrant’s Annual Report on Form 10-K, filed on March 11, 2021)
10.5.3
Third Lease Amendment, dated as of September 9, 2021, by and between the Company and Duke & Duke. (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on
November 12, 2021)
10.6*
Ocuphire Pharma, Inc. 2018 Equity Incentive Plan, dated as of April 9, 2018 (incorporated by reference to Exhibit 10.35 to the Registrant’s Registration Statement on Form S-4 (File No. 333-239702), filed on
September 30, 2020).
10.6.1*
First Amendment to 2018 Equity Incentive Plan, dated as of December 23, 2019 (incorporated by reference to Exhibit 10.36 to the Registrant’s Registration Statement on Form S-4 (File No. 333-239702), filed
on September 30, 2020).
10.6.2*
Form of Option Agreement issuable under the Ocuphire Pharma, Inc. 2018 Equity Incentive Plan (incorporated by reference to Exhibit 10.37 to the Registrant’s Registration Statement on Form S-4 (File No.
333-239702), filed on September 30, 2020).
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10.7*
Ocuphire Pharma, Inc. 2020 Equity Incentive Plan (incorporated by reference to Exhibit 10.38 to the Registrant’s Registration Statement on Form S-4 (File No. 333-239702), filed on September 30, 2020).
10.8
Contingent Value Rights Agreement, dated as of November 5, 2020, by and among the Company, Shareholder Representative Services LLC and the Olde Monmouth Stock Transfer Co., Inc. (incorporated by reference
to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K, filed on November 6, 2020).
10.9*
Ocuphire Pharma, Inc. 2021 Inducement Plan (incorporated by reference to Exhibit 10.41 to the Registrant’s Annual Report on Form 10-K, filed on March 11, 2021)
10.10*
Employment Agreement dated November 11, 2020, by and between the Company and Amy Rabourn (incorporated by reference to Exhibit 10.42 to the Registrant’s Annual Report on Form 10-K, filed on March 11, 2021)
10.11
Capital on Demand™ Sales Agreement, dated March 11, 2021 between the Company and JonesTrading Institutional Services LLC (incorporated by reference to Exhibit 1.1 to the Registrant’s Current Report on Form
8-K, filed on March 11, 2021).
10.12
Form of Securities Purchase Agreement, dated as of June 4, 2021, by and among Ocuphire Pharma, Inc. and the purchasers identified on the signature pages thereto (incorporated by reference to Exhibit 10.1 to
the Registrant’s Current Report on Form 8-K/A, filed on June 7, 2021).
10.13
Processa License Agreement dated June 16, 2021 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on June 23, 2021).
21.1
Subsidiaries of the Registrant
23.1
Consent of Ernst & Young, LLP.
31.1
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
31.2
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to section 302 of the Sarbanes-Oxley Act of
2002
32.1
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rules 13a-14(b) and 15d-14(b) promulgated under the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, as
adopted pursuant to section 906 of The Sarbanes-Oxley Act of 2002
101.INS
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document).
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
*
Indicates management contract or compensatory plan.
+
Certain schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request.
++
Portions of this exhibit have been omitted in compliance with Item 601 of Regulation S-K.
ITEM 16.
FORM 10-K SUMMARY
None
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ITEM 8.
CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 )
126
Consolidated Balance Sheets
128
Consolidated Statements of Comprehensive Loss
129
Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
130
Consolidated Statements of Cash Flows
131
Notes to Consolidated Financial Statements
132
125
Table of Contents
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders
Ocuphire Pharma, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Ocuphire Pharma, Inc. (the Company) as of December 31, 2021 and 2020, the related consolidated
statements of comprehensive loss, changes in stockholders’ equity (deficit) and cash flows for each of the two years in the period ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial
statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2021 and 2020, and the results of its operations and its cash flows for each
of the two years in the period ended December 31, 2021, in conformity with U.S. generally accepted accounting principles.
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. As discussed in Note 1 to the financial statements,
the Company has suffered recurring losses from operations, has negative cash flow from operations, and has stated that substantial doubt exists about the Company’s ability to continue as a going concern. Management’s evaluation of the events
and conditions and management’s plans regarding these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We
are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are
required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such
opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that were communicated or required to be communicated to the
audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not
alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or
disclosures to which it relates.
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Accounting for Warrants
Description of
the Matter
As discussed in Notes 1 and 9 to the consolidated financial statements, in connection with the merger transaction, the Company issued Series A and Series B warrants (collectively, the Warrants) to purchase additional common stock on
November 19, 2020 (the Warrant Closing Date). As of the Warrant Closing Date and December 31, 2020, the Series A warrants were determined to be liability classified instruments and the Series B warrants were determined to be equity
classified instruments. On February 3, 2021, the Company entered into Waiver Agreements which, among other things, modified certain features of the Warrants. Upon the effective date of the Waiver Agreements, the Series A warrants were
reclassified to equity.
Auditing the accounting conclusions related to the Warrants was challenging because of the complex provisions affecting valuation and classification and required extensive audit effort. The accounting for the Warrants involved an
assessment of the particular features of each type of warrant, and the impact of those features on the accounting and classification of the Warrants.
How we
Addressed the
Matter in Our
Audit
To test the accounting and determine proper classification of the Warrants, our audit procedures included, among others, inspecting the agreements and evaluating the completeness and accuracy of the Company’s technical accounting
analyses, application of the relevant accounting guidance and review of legal interpretation from counsel. Our audit procedures also included the involvement of subject matter resources to assist in evaluating management’s conclusion on
the interpretation and application of the relevant accounting literature.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2018.
Detroit, Michigan
March 24, 2022
127
Table of Contents
Ocuphire Pharma, Inc.
Consolidated Balance Sheets
(in thousands, except share amounts and par value)
As of December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
24,534
$
16,399
Prepaids and other current assets
1,314
1,269
Short-term investments
219
—
Total current assets
26,067
17,668
Property and equipment, net
10
14
Total assets
$
26,077
$
17,682
Liabilities and stockholders’ equity (deficit)
Current liabilities:
Accounts payable
$
1,584
$
1,214
Accrued expenses
1,733
1,971
Short-term loan
538
—
Total current liabilities
3,855
3,185
Warrant liabilities
—
27,964
Total liabilities
3,855
31,149
Commitments and contingencies (Note 3 and Note 9)
Stockholders’ equity (deficit)
Preferred stock, par value $ 0.0001 ; 10,000,000 shares authorized as of December 31, 2021 and 2020 ; no shares issued and outstanding at December 31, 2021 and 2020 .
—
—
Common stock, par value $ 0.0001 ; 75,000,000 shares authorized as of December 31, 2021 and 2020 ; 18,845,828 and 10,882,495 shares issued
and outstanding at December 31, 2021 and 2020 , respectively.
2
1
Additional paid-in capital
111,588
19,207
Accumulated deficit
( 89,368
)
( 32,675
)
Total stockholders’ equity (deficit)
22,222
( 13,467
)
Total liabilities and stockholders’ equity (deficit)
$
26,077
$
17,682
See accompanying notes.
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Table of Contents
Ocuphire Pharma, Inc.
Consolidated
Statements of Comprehensive Loss
(in thousands, except share and per share amounts)
For the Year Ended
December 31,
2021
2020
Collaborations revenue
$
589
$
—
Operating expenses:
General and administrative
8,121
2,818
Research and development
15,173
6,648
Acquired in-process research and development
—
10,502
Total operating expenses
23,294
19,968
Loss from operations
( 22,705
)
( 19,968
)
Interest expense
( 2
)
( 6,847
)
Fair value change in derivative and warrant liabilities
( 33,829
)
( 1,486
)
Gain on note extinguishment
—
3,672
Other (expense) income, net
( 157
)
9
Loss before income taxes
( 56,693
)
( 24,620
)
Benefit (provision) for income taxes
—
—
Net loss
( 56,693
)
( 24,620
)
Other comprehensive loss, net of tax
—
—
Comprehensive loss
$
( 56,693
)
$
( 24,620
)
Net loss per share:
Basic and diluted (Note 11)
$
( 3.82
)
$
( 5.28
)
Number of shares used in per share calculations:
Basic and diluted
14,852,745
4,661,110
See accompanying notes.
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Ocuphire Pharma, Inc.
Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
(in thousands, except share amounts)
Common Stock
Additional
Paid–In
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit
Equity
(Deficit)
Balance at December 31, 2019
2,852,485
$
—
$
495
$
( 8,055
)
$
( 7,560
)
Issuance of common stock in exchange for in-process research and development
891,422
—
2,126
—
2,126
Gain on note extinguishment
—
—
971
—
971
Conversion of convertible notes into common stock upon close of the merger
977,128
—
6,953
—
6,953
Issuance of common stock and warrants in connection with pre-merger financing
4,999,988
1
( 1
)
—
—
Issuance costs attributed to pre-merger financing
—
—
( 1,080
)
—
( 1,080
)
Issuance of common stock, warrants and options to former Rexahn stockholders and effect of asset acquisition
1,120,800
—
8,115
—
8,115
Share-based compensation
—
—
1,506
—
1,506
Reclassification of Rexahn warrants from liability to equity
—
—
64
—
64
Exercise of stock options
40,672
—
58
—
58
Net and comprehensive loss
—
—
—
( 24,620
)
( 24,620
)
Balance at December 31, 2020
10,882,495
1
19,207
( 32,675
)
( 13,467
)
Reclassification of Series A warrant liability to equity
—
—
61,793
—
61,793
Issuance of common stock and warrants in connection with registered direct offering
3,076,923
1
14,999
—
15,000
Issuance of common stock in connection with the at-the-market program
2,778,890
—
13,491
—
13,491
Issuance of common stock in connection with settlement with investors
350,000
—
1,614
—
1,614
Issuance costs
—
—
( 1,517
)
—
( 1,517
)
Exercise of Series B warrants
1,629,634
—
—
—
—
Share-based compensation
54,444
—
1,914
—
1,914
Exercise of stock options
73,442
—
87
—
87
Net and comprehensive loss
—
—
—
( 56,693
)
( 56,693
)
Balance at December 31, 2021
18,845,828
$
2
$
111,588
$
( 89,368
)
$
22,222
See accompanying notes.
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Ocuphire Pharma, Inc.
Consolidated
Statements of Cash Flows
(in thousands)
For the Year Ended
December 31,
2021
2020
Operating activities
Net loss
$
( 56,693
)
$
( 24,620
)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation
1,914
1,506
Depreciation
4
8
Non-cash acquired in-process research and development
—
10,502
Gain on note extinguishment
—
( 3,672
)
Non-cash interest on convertible notes
—
492
Non-cash interest on convertible notes – related party
—
51
Non-cash discount amortization on convertible notes
—
873
Non-cash discount amortization on convertible notes – related party
—
71
Fair value change in derivative and warrant liabilities
33,829
1,486
Non-cash interest attributed to Series A warrant issuance
—
4,671
Issuance costs attributed to Series A warrants
—
689
Non-cash share settlement with investors
1,614
—
Receipt of investments related to license agreement
( 289
)
—
Unrealized loss from short-term investments
70
—
Change in assets and liabilities:
Prepaid expenses and other assets
( 45
)
( 906
)
Accounts payable
381
792
Accrued expenses
( 155
)
1,260
Net cash used in operating activities
( 19,370
)
( 6,797
)
Investing activities
Cash acquired in connection with asset acquisition
—
2,014
Transaction costs in connection with asset acquisition
( 100
)
( 1,475
)
Net cash (used in) provided by investing activities
( 100
)
539
Financing activities
Proceeds from pre-merger financing
—
21,150
Proceeds from issuance of common stock
28,491
—
Proceeds from issuance of convertible notes
—
2,197
Issuance costs attributed to pre-merger financing
—
( 1,769
)
Issuance costs attributed to common stock and convertible notes
( 1,511
)
( 10
)
Proceeds from short-term loan
646
—
Payment made on short-term loan principal
( 108
)
—
Settlement of Rexahn warrants
—
( 506
)
Exercise of stock options
87
58
Net cash provided by financing activities
27,605
21,120
Net increase in cash and cash equivalents
8,135
14,862
Cash and cash equivalents at beginning of period
16,399
1,537
Cash and cash equivalents at end of period
$
24,534
$
16,399
Supplemental disclosure of cash flow information:
Cash paid for income taxes
$
—
$
—
Cash paid for interest
$
2
$
—
Supplemental non-cash financing transactions:
Non-cash reclassification of Series A warrant liability to equity
$
61,793
$
—
Non-cash conversion of convertible notes to common stock
$
—
$
9,365
Common stock and warrants issued in connection with the asset acquisition
$
—
$
8,883
Unpaid transaction costs in connection with asset acquisition
$
—
$
100
Net assets assumed in connection with asset acquisition
$
—
$
68
Bifurcation and modification of premium conversion derivative related to convertible notes
$
—
$
831
Unpaid issuance costs
$
6
$
—
See accompanying notes.
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Ocuphire Pharma, Inc.
Notes to Consolidated Financial Statements
1.
Company Description and Summary of Significant Accounting Policies
Nature of Business
Ocuphire is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders. Ocuphire ’s pipeline currently includes two small molecule product candidates targeting several of such indications. The Company’s lead product candidate, Nyxol® Eye Drops (“Nyxol”), is
a once-daily eye drop formulation of phentolamine mesylate designed to reduce pupil diameter and improve visual acuity. The Company’s second product candidate, APX3330, is a twice-a-day oral tablet designed to target multiple pathways
relevant to retinal and choroidal (the vascular layer of the eye) diseases such as diabetic retinopathy (“DR”) and diabetic macular edema (“DME”) which, if left untreated, can result in permanent visual acuity loss and eventual
blindness . The Company has also in-licensed APX2009 and APX2014, which are second-generation product candidates and analogs of APX3330.
The Company has sustained operating losses since inception and expects such losses to continue indefinitely until a sustained revenue source is realized.
Management plans to continue financing the Company’s operations primarily through additional issuances of the Company’s equity and debt securities. If adequate funds are not available, the Company may be required to delay, reduce the scope
of, or eliminate part or all of its research and development programs.
Reverse Merger with Rexahn
On June 17, 2020, Ocuphire, Rexahn Pharmaceuticals, Inc. (“Rexahn”), Razor Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Rexahn (“Merger
Sub”), entered into an Agreement and Plan of Merger and Reorganization, as amended on June 29, 2020 (as amended, the “Merger Agreement”), pursuant to which, among other things, and subject to the satisfaction or waiver of certain conditions set
forth in the Merger Agreement, Merger Sub would merge with and into Ocuphire, with Ocuphire continuing as a wholly-owned subsidiary of Rexahn and the surviving corporation of the merger (the “Merger”). The Merger closed on November 5, 2020. Upon
completion of the Merger, Rexahn changed its name to Ocuphire Pharma, Inc. and changed its ticker symbol on the Nasdaq Capital Market to “OCUP”.
The Company’s headquarters is located in Farmington Hills, Michigan.
COVID-19
As a result of the COVID-19 pandemic, the Company has experienced, and will likely continue to experience, delays and disruptions in our clinical trials, as well
as interruptions in our manufacturing, supply chain, shipping and research and development operations.
The Company’s plans for further testing or clinical trials may be further impacted by the continuing effects of COVID-19. The global outbreak of COVID-19
continues to evolve. The extent to which the COVID-19 pandemic may further impact our business and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the effect of
the pandemic on our suppliers and distributors and the global supply chain, the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and social distancing in the U.S. and other countries, business
closures or business disruptions and the effectiveness of actions taken in the U.S. and other countries to contain and treat the disease. The COVID-19 pandemic may also continue to impact our business as a result of employee illness, school
closures, and other community response measures.
The COVID-19 pandemic may also impact the Company’s ability to secure additional financing. Although the Company cannot estimate the length or gravity of the
impact of the COVID-19 outbreak at this time, if the pandemic continues, it may have a material adverse effect on the Company’s results of future operations, financial position, and liquidity in for fiscal year 2022 and beyond.
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Notes to Consolidated Financial Statements
Basis of Presentation
The accompanying financial statements have been prepared in accordance with accounting standards generally accepted in the United States of America (“GAAP”).
All of the share and per share amounts presented were adjusted, on a retroactive basis, to reflect the exchange of the shares of Ocuphire pre-Merger (“Private
Ocuphire”) into 1.0565 shares of the Company (the “Exchange Ratio”), except for par value and share authorizations of Private Ocuphire
for periods presented prior to the Merger.
On December 31, 2021, the Company merged its wholly owned subsidiary, OcuSub Inc, with and into the Company, with the Company remaining as the surviving entity.
The merger of the Company’s wholly owned subsidiary did not have a financial impact to the periods presented. Upon close of this merger, the Company did not have any remaining entities that required consolidation for financial statement
reporting purposes.
Going Concern
The Company’s ability to continue operating as a going concern is contingent upon, among other things, its ability to secure additional financing and to achieve and
maintain profitable operations. The Company plans to issue additional equity instruments and possibly debt to finance operating and working capital requirements. While the Company expects to obtain the additional financing that is needed, there
is no assurance that the Company will be successful in obtaining the necessary funding for future operations. These factors raise substantial doubt as to the Company’s ability to continue as a going concern. The consolidated financial statements
do not include any adjustments that might result from the outcome of these uncertainties.
Common Stock Valuation
Prior to the close of the Merger, due to the absence of an active market for the Private Ocuphire’s common stock, the Company utilized methodologies in accordance
with the framework of the American Institute of Certified Public Accountants’ Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation , to estimate the fair
value of Private Ocuphire common stock. The valuation methodology included estimates and assumptions that required the Company’s judgment. These estimates and assumptions included a number of objective and subjective factors, including external
market conditions affecting the biotechnology industry sector, and the likelihood of achieving a liquidity event, such as an initial public offering (“IPO”), reverse merger or sale. Significant changes to the key assumptions used in the
valuations resulted in different fair values of common stock at each valuation date.
For the valuation of equity awards granted in October 2020 and September 2020, the Company used a contemporaneous third-party valuation of $ 8.76 and $ 7.89 per share, respectively.
For the valuation of equity awards granted in April 2020 and June 2020, the Company applied a straight-line calculation using the contemporaneous third-party valuations of $ 1.74 per share as of March 31, 2020 and $ 9.54 per share as of
June 18, 2020 to determine the fair value of Private Ocuphire common stock. Using the benefit of hindsight, the Company determined that the straight-line calculation would provide the most reasonable conclusion for the valuation of the Company’s
common stock on these interim dates between valuations because the Company did not identify any single event or series of events that occurred during this interim period that would have caused a material change in fair value. Based on this
calculation, the Company assessed the fair value of its common stock for awards granted in April 2020 and June 2020 at $ 2.33 and $ 8.65 per share, respectively.
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Notes to Consolidated Financial Statements
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported
in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates.
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 one operating segment, which is the business of development and commercialization of products related to vision
performance and health. Accordingly, the Company has a single reporting segment.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of deposit to be cash equivalents.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company’s cash is held
by two long-standing financial institutions in the United States. Amounts on deposit may at times exceed federally insured limits. Management believes that the financial institutions are financially sound, and accordingly, minimal credit
risk exists with respect to the financial institutions. As of December 31, 2021, the Company had deposits that exceeded federally insured amounts by approximately $ 24.0 million.
Short-term Investments
The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and are recorded on a settlement
date basis. The Company’s investments are comprised of equity securities, which in accordance with the fair value hierarchy described below are recorded at fair value using Level l inputs on the consolidated balance sheets. Subsequent
changes in fair values are recorded in other (expense) income, net on the consolidated statements of comprehensive loss. The Company classifies investments available to fund current operations as current assets on its consolidated balance
sheets. The Company did no t recognize any impairments on its investments to date through December 31, 2021.
Revenue Recognition
The Company follows the provisions of Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers . The guidance provides a five-step model to determine
how revenue is recognized. The Company has entered into license agreements which have revenue recognition implications. (See Note 10 – Collaboration License Agreements.)
In determining the appropriate amount of revenue to be recognized, the Company performs the following steps: (i) identification of the contracts with a
customer; (ii) determination of the performance obligations in the contract; (iii) measurement of the transaction price, including potential constraints on variable consideration; (iv) allocation of the transaction price to the performance
obligations based on estimated stand-alone selling prices; and (v) recognition of revenue when (or as) the Company satisfies a performance obligation.
A performance obligation is a promise in a contract to transfer a distinct good or service to
the customer and is the unit of account in ASC 606. Performance obligations may include license rights, development services, and services associated with regulatory submission and approval processes. Significant management judgment is
required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its
performance obligations are either completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of
performance using the cumulative catch-up method.
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Notes to Consolidated Financial Statements
As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each
performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount
rates and probabilities of technical and regulatory success. The Company allocates the total transaction price to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service
underlying each performance obligation.
Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations
identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. For licenses
that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if
over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of
performance and related revenue recognition.
Milestone payments: At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable
of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a
regulatory submission) is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable of being achieved until such contingency occurs
(such as receipt of those approvals). When the Company’s assessment of probability of achievement changes and variable consideration becomes probable, any additional estimated consideration is allocated to each performance obligation based
on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation and recorded in collaborations revenue based upon when the customer obtains control of each element.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the
predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been
satisfied (or partially satisfied).
General and Administrative Expenses
General and administrative expenses (“G&A”) 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 relating to intellectual property and corporate matters, professional fees for accounting and tax services, settlement costs
with third parties and other services provided by business consultants.
Research and Development
Research and development expenses (“R&D”) consist of costs incurred in performing research and development activities, including compensation for research and
development employees and consultants, costs associated with preclinical studies and clinical trials, regulatory activities, manufacturing activities to support clinical activities, license fees, fees paid to external service providers that
conduct certain research and development, and an allocation of R&D related overhead expenses.
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Ocuphire Pharma, Inc.
Notes to Consolidated Financial Statements
Acquired In‑Process Research and Development Expenses
The Company includes costs to acquire or in‑license product candidates as acquired in‑process research and development expenses (“IPR&D”). These costs are
immediately expensed provided that the payments do not also represent processes or activities that would constitute a “business” as defined under GAAP or provided that the product candidate has not achieved regulatory approval for marketing, and
absent obtaining such approval, has no alternative future use. Royalties owed on future sales of any licensed product will be expensed in the period the related revenues are recognized. See Note 8 – Apexian Sublicense Agreement.
Other (Expense) Income, net
Other (expense) income, net reflected in this line item includes payments made by the Company in connection with the Contingent Value Rights Agreement discussed
further below with former Rexahn shareholders. In addition, Other (expense) income, net includes interest earned from cash and cash equivalent investments, realized and unrealized gains (losses) from equity investments and reimbursements in
connection with grants and other sources.
Share‑Based Compensation
The Company accounts for share‑based compensation in accordance with the provisions of the Financial Accounting Standards Board (“FASB”) Accounting Standards
Codification (“ASC 718”), Compensation — Stock Compensation . Accordingly, compensation costs related to equity instruments granted are recognized at the grant‑date fair value. The Company records
forfeitures when they occur. Share‑based compensation arrangements to non‑employees are accounted for in accordance with the applicable provisions of ASC 718.
Warrant Liabilities
The Company issued Series A Warrants in connection with the Pre-Merger Financing (see Note 9 – Pre-Merger Financing) and assumed Rexahn warrants issued prior to
the Merger. The Company accounts for these warrants as a liability while outstanding at fair value during periods when certain provisions preclude equity accounting treatment for these instruments. Additionally, issuance costs associated with
the warrants classified as liabilities are expensed as incurred and reflected as interest expense in the accompanying consolidated statements of comprehensive loss. The change in fair value of the warrant liabilities while outstanding were
recognized as a component of the fair value change in derivative and warrant liabilities line item in the consolidated statements of comprehensive loss.
Premium Conversion Derivatives
The Company evaluates all conversion and redemption features contained in a debt instrument to determine if there are any embedded derivatives that require
separation from the host debt instrument. An embedded derivative that requires separation is bifurcated from its host debt instrument and a corresponding discount to the host debt instrument is recorded. The discount is amortized and recorded to
interest expense over the term of the host debt instrument using the straight-line method which approximates the effective interest method. The embedded derivative is accounted for separately on a fair market value basis while outstanding. The
Company records the fair value changes of a separated embedded derivative at each reporting period in the fair value change in derivative and warrant liabilities line item in the accompanying consolidated statements of comprehensive loss. The
Company determined that the redemption features under the convertible notes, while they were outstanding, qualified as embedded derivatives and were separated from their debt hosts.
Fair Value Measurements
The Company follows accounting guidance that emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Fair value is defined as
“the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy:
•
Level 1 inputs: Unadjusted quoted prices for identical assets or liabilities in active markets;
•
Level 2 inputs: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the
asset or liability; and
•
Level 3 inputs: Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or
liability at the measurement date.
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Ocuphire Pharma, Inc.
Notes to Consolidated Financial Statements
As of December 31, 2021 and 2020, the fair values of cash and cash equivalents, prepaid and other assets, accounts
payable, accrued expenses and short-term loan approximated their carrying values because of the short-term nature of these assets or liabilities. The estimated fair value of the Company’s convertible notes while outstanding were based on
amortized cost which was deemed to approximate fair value. The fair value of the investments, while outstanding, were based on observable Level 1 inputs in the form of quoted market prices from a major stock exchange. The fair value of the
warrant liabilities and premium conversion derivatives, while outstanding, were based on cash flow models discounted at current implied market rates evidenced in recent arms-length transactions representing expected returns by market
participants for similar instruments and were based on Level 3 inputs. There were no transfers between fair value
hierarchy levels during the years ended December 31, 2021 and 2020.
The fair value of financial instruments measured on a recurring basis is as follows (in thousands):
As of December 31, 2021
Description
Total
Level 1
Level 2
Level 3
Assets:
Short-term investments
$
219
$
219
$
—
$
—
Total assets at fair value
$
219
$
219
$
—
$
—
As of December 31, 2020
Description
Total
Level 1
Level 2
Level 3
Liabilities:
Warrant liabilities
$
27,964
$
—
$
—
$
27,964
Total liabilities at fair value
$
27,964
$
—
$
—
$
27,964
The following table provides a roll-forward of investments measured at fair value on a recurring basis using observable level 1 inputs for the year ended December
31, 2021 and 2020 (in thousands):
2021
2020
Short-term investments
Balance as of beginning of period
$
—
$
—
Receipt of investments related to license agreement
289
—
Unrealized loss
( 70
)
—
Balance as of end of period
$
219
$
—
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Ocuphire Pharma, Inc.
Notes to Consolidated Financial Statements
The following table provides a roll-forward of the warrant liabilities and premium conversion derivatives measured at fair value on a recurring basis using
unobservable level 3 inputs for the years ended December 31, 2021 and 2020 (in thousands):
2021
2020
Warrant liabilities
Balance as of beginning of period
$
27,964
$
—
Value assigned to warrants upon in connection with pre-merger financing
—
25,821
Issuance of warrants to former Rexahn stockholders classified as a liability
—
768
Cash settlement of warrant liabilities
—
( 506
)
Change in fair value of warrant liabilities
33,829
1,945
Reclassification of warrants from liability to equity
( 61,793
)
( 64
)
Balance as of end of period
$
—
$
27,964
2021
2020
Premium conversion derivatives
Balance as of beginning of period
$
—
$
2,714
Value assigned to the underlying derivatives in connection with convertible notes
—
831
Revaluation due to convertible note extinguishment
—
( 3,086
)
Change in fair value of premium conversion derivatives
—
( 459
)
Balance as of end of period
$
—
$
—
There were no financial instruments measured on a
non-recurring basis for any of the periods presented.
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 no provision for income taxes, as the Company has incurred operating losses to date, and a full valuation allowance has been provided on the net deferred tax assets.
Property and Equipment
Property and equipment, net 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. Equipment and furniture are depreciated over a five year estimated useful life. Tangible
assets acquired for research and development activities which have alternative use are capitalized and depreciated over the useful life of the acquired asset. Estimated useful lives are periodically reviewed, and when appropriate, changes are
made prospectively. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts. Maintenance and repairs are charged
directly to expense as incurred.
Recent Accounting Pronouncements
In June 2016, the FASB issued Accounting Standards Update (“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. The Company does not expect that the adoption of this ASU on January 1, 2023 will have a significant impact on its consolidated financial statements.
In August 2020, 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 EPS computation. The amendments in this ASU are effective for public business entities that meet the definition of a Securities and Exchange
Commission (“SEC”) filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the
amendments are effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. The Company is currently evaluating the impact of ASU 2020-06 on its consolidated financial statements.
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Ocuphire Pharma, Inc.
Notes to Consolidated Financial Statements
In November 2021, the FASB issued ASU 2021-10, Government
Assistance (Topic 832) - Disclosures by Business Entities about Government Assistance, to increase the transparency of government assistance including the disclosure of the types of assistance, an entity’s accounting for the
assistance, and the effect of the assistance on an entity’s financial statements. The amendments in this ASU are effective for all entities within their scope for financial statements issued for annual periods beginning after December 15, 2021.
The Company is currently evaluating the impact of the adoption of Topic 832.
2.
Merger
On November 5, 2020, the Company completed its merger transaction with Rexahn in accordance with the terms of the Merger Agreement. Immediately after the Merger,
there were approximately 7,091,878 shares of the Company’s common stock, par value $ 0.0001 per share (the “Common Stock”) outstanding (not including 3,749,992
Additional Shares under the Securities Purchase Agreement that were held in escrow subject to final adjustment). The former stockholders and option holders of Private Ocuphire (including the Investors under the Securities Purchase Agreement)
owned, or held rights to acquire, in the aggregate approximately 86.6 % of the fully-diluted Common Stock, which for these purposes is
defined as the outstanding Common Stock, plus outstanding options of the Company, and not including any Additional Shares (the “Fully-Diluted Common Stock”), with the former Rexahn stockholders immediately prior to the Merger owning approximately
13.4 % of the Fully-Diluted Common Stock. Pursuant to the Merger Agreement, the number of shares of Common Stock issued to Private
Ocuphire’s stockholders for each share of Ocuphire’s common stock outstanding immediately prior to the Merger was calculated using an Exchange Ratio of approximately 1.0565 shares of Common Stock for each share of Private Ocuphire common stock. Immediately following the Merger, the stockholders of Private Ocuphire owned approximately
86.6 % of the outstanding common stock of the Company.
The transaction was accounted for as an asset acquisition in accordance with GAAP. Under this method of accounting, Private Ocuphire was deemed to be the accounting
acquirer for financial reporting purposes. This determination was primarily based on the facts that, immediately following the Merger: (i) Private Ocuphire’s stockholders owned substantially all of the voting rights in the combined company, (ii)
Private Ocuphire designated all, but one , of the members of the initial board of directors of the combined company, and (iii) Private
Ocuphire’s senior management holds all key positions in the senior management of the combined company. As a result, as of the closing date of the Merger, the net assets of Rexahn were recorded at their acquisition-date relative fair values in the
consolidated financial statements of the Company and the reported operating results prior to the Merger are those of Private Ocuphire.
The total purchase price paid in the Merger has been allocated to the net assets acquired and liabilities assumed based on their fair values as of the completion of
the Merger. The following summarizes the purchase price paid in the Merger (in thousands, except share and per share amounts):
Number of shares of the combined organization owned by the Company’s Pre-Merger stockholders
1,120,800
Multiplied by the fair value per share of REXN’s common stock (1)
$
7.24
Fair value of common stock issued to affect the Merger
8,115
Fair value of warrants and options issued to affect the Merger
768
Transaction costs
1,575
Purchase price
$
10,458
(1)
Based on the last reported sale price of the Rexahn’s common stock on the Nasdaq Capital Market on November 5, 2020, the closing date of
the Merger, and gives effect to the Reverse Stock Split.
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Notes to Consolidated Financial Statements
The allocation of the purchase price is as follows:
Cash acquired
$
2,014
Net assets assumed
68
IPR&D (2)
8,376
Purchase price
$
10,458
(2)
Represents the pre-Merger research and development projects of Rexahn which were in-process, but not yet
completed, and which the Company may advance post-Merger. This includes the development of RX-3117, RX-0301 and RX-0047. Current accounting standards require that the fair value of IPR&D projects acquired in an asset acquisition with
no alternative future use be allocated a portion of the consideration transferred and charged to expense on the acquisition date. The acquired assets did not have outputs or employees.
Contingent Value Rights Agreement
On November 5, 2020, in connection with the Merger, the Company, Shareholder Representatives Services LLC, as representative of the Rexahn stockholders prior to
the Merger, and Olde Monmouth Stock Transfer Co., Inc., as the rights agent, entered into a Contingent Value Rights Agreement (the “CVR Agreement”).
Pursuant to the Merger Agreement and the CVR Agreement, Rexahn stockholders of record as of immediately prior to the Effective Time received one contingent value right (“CVR”) for each share of Rexahn Common Stock held.
Each CVR entitles such holders to receive, for each calendar quarter (each, a “CVR Payment Period”) during the 15 -year period after the Closing (the “CVR Term”), an amount equal to the following:
•
90 % of all payments received by Rexahn or its affiliates during such
CVR Payment Period from or on behalf of BioSense Global LLC (“BioSense”) pursuant to that certain License and Assignment Agreement, dated as of February 25, 2019, by and between BioSense and Rexahn, as amended by Amendment No. 1,
dated August 24, 2019, and as further amended by Amendment No. 2, dated March 10, 2020, minus certain permitted deductions;
•
90 % of all payments received by Rexahn or its affiliates during such
CVR Payment Period from or on behalf of Zhejiang HaiChang Biotechnology Co., Ltd. (“HaiChang”) pursuant to that certain Exclusive License Agreement, dated as of February 8, 2020, by and between HaiChang and Rexahn, minus certain
permitted deductions; and
•
75 % of the sum of (i) all cash consideration paid by a third party to
Rexahn or its affiliates during the applicable CVR Payment Period in connection with the grant, sale or transfer of rights to Rexahn’s pre-Closing intellectual property (other than a grant, sale or transfer of rights involving a sale
or disposition of the post-Merger combined company) that is entered into during the 10 -year period after the Closing
(“Parent IP Deal”), plus (ii) with respect to any non-cash consideration received by Rexahn or its affiliates from a third party during the applicable CVR Payment Period in connection with any Parent IP Deal, all amounts received by
Rexahn and its affiliates for such non-cash consideration at the time such non-cash consideration is monetized by Rexahn or its affiliates, minus (iii) certain permitted deductions.
The CVRs are not transferable, except in certain limited circumstances, will not be certificated or evidenced by any instrument, will not accrue interest and will not be registered with the SEC or listed for trading on any exchange.
The CVR Agreement will continue in effect until the later of the end of the CVR Term and the payment of all amounts payable thereunder. As of December 31, 2021, $ 91,000 was paid under the CVR Agreement and was recorded in the other (expense) income, net line item in the condensed consolidated statements of comprehensive loss .
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Ocuphire Pharma, Inc.
Notes to Consolidated Financial Statements
As of the
November 5, 2020, the Merger closing date, and December 31, 2021, no additional milestones under the license agreements
subject to the CVR Agreement had been accrued as there were no potential milestones yet considered probable.
Former Rexahn Warrants and Stock Options
Following the closing of the Merger, 231,433
outstanding, unexercised Rexahn warrants to purchase Common Stock remained outstanding, the majority of which were subsequently repurchased according to the terms of the original warrant agreements. As of December 31, 2021, 66,538 of the Rexahn warrants remained outstanding with exercise prices ranging from $ 38.40 to $ 198.00 per share with an average remaining
contractual life of 1.9 years. In addition, there were 993 outstanding, unexercised Rexahn stock options to purchase Common Stock upon close of the Merger of which 82 options were outstanding as of December 31, 2021 (see Note 7 – Share-based Compensation).
3.
Commitments and Contingencies
Apexian Sublicense Agreement
On January 21, 2020, the Company entered into a sublicense agreement with Apexian Pharmaceuticals, Inc., pursuant to which it obtained exclusive worldwide patent and
other intellectual property rights. In exchange for the patent and other intellectual rights, the Company agreed to certain milestone and royalty payments on future sales (See Note 8 — Apexian Sublicense Agreement). As of December 31, 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 sublicense agreement, and as such, no liabilities were recorded
related to the sublicense agreement.
Facility Leases
In May 2019, the Company entered into a short-term non-cancellable facility lease (the “Lease”) for its operations and headquarters for a seven-month term beginning in June 2019. The Lease, as amended, has extended the term to December 31, 2022. Additionally, Ocuphire leased office space
in Rockville, Maryland through June 30, 2021 previously occupied by Rexahn (the “Rexahn Lease”). The Lease and the Rexahn Lease qualified for the short-term lease exception under ASC 842, Leases . The
monthly base rent, as amended, for the Lease is approximately $ 3,000 . The monthly base rent for the Rexahn Lease was $ 13,000 . The rent expense associated with the Lease and Rexahn Lease amounted to $ 116,000 and $ 54,000 during the years ended December 31, 2021 and 2020,
respectively. Total expected rental payments under the Lease for the year ended December 31, 2022 are approximately $ 36,000 .
Issuance of Settlement Shares
On May 6, 2021, the Company issued 350,000 shares of common stock of the Company to three accredited investors
pursuant to a settlement agreement, dated May 6, 2021, in exchange for a release of potential claims. The fair value of the share settlement of $ 1,614,000
was based on the closing Ocuphire stock price for that day. The fair value of the share settlement was recorded in general and administrative expenses in the accompanying consolidated statements of comprehensive loss.
Other
In the ordinary course of business, from time to time, the Company may be subject to a broad range of claims and legal proceedings that relate to contractual
allegations, patent infringement and other claims. In addition, the Company from time to time may be potentially committed to reimburse third parties for costs incurred associated with business development related transactions upon the
achievement of certain milestones. The Company establishes accruals when applicable for matters and commitments which it believes losses are probable and can be reasonably estimated. To date, no loss contingency for such matters and potential
commitments have been recorded. Although it is not possible to predict with certainty the outcome of these matters or potential commitments, the Company is of the opinion that the ultimate resolution of these matters and potential commitments
will not have a material adverse effect on its results of operations or financial position.
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Notes to Consolidated Financial Statements
4.
Supplemental Balance Sheet Information
Prepaid and Other Assets
Prepaid and other assets consist of the following (in thousands):
December 31,
2021
2020
Prepaids
$
1,243
$
1,243
Other
71
26
Total prepaids and other assets
$
1,314
$
1,269
Property and Equipment, net
Property and equipment held for use by category are presented in the following table (in thousands):
December 31,
2021
2020
Equipment
$
20
$
20
Furniture
5
5
Total property and equipment
25
25
Less accumulated depreciation
( 15
)
( 11
)
Property and equipment, net
$
10
$
14
Depreciation expense was $ 4,000 and $ 8,000 for the years ended December 31, 2021 and 2020, respectively.
Accrued Expenses
Accrued expenses consist of the following (in thousands):
December 31,
2021
2020
R&D services and supplies
$
1,081
$
1,440
Payroll
488
320
Professional services
84
186
Other
80
25
Total
$
1,733
$
1,971
Short-Term Loan
The Company entered into an unsecured short-term loan (the “Loan”) agreement in the amount of $ 0.6 million in November 2021 related to financing an insurance policy. The Loan is payable in six monthly installments of $ 108,000 beginning in December 2021. The Loan
has an annual interest rate of 5.5 % per annum. Interest expense in the amount of $ 2,000 was recognized in connection with the Loan during the year ended December 31, 2021.
5.
Convertible Notes
The Company entered into a series of unsecured convertible note financings (the “Convertible Notes”) with certain investors beginning on May 25, 2018. The total
issuance of Convertible Notes amounted to $ 8.5 million (see Note 6 – Related Party Transactions). On November 4, 2020, all of Ocuphire’s outstanding Convertible Notes were converted into 977,128 shares of Ocuphire common
stock as adjusted for the Exchange Ratio in connection with the completion of the Merger. The conversion was accounted for as a debt extinguishment given the bifurcation of the embedded premium conversion derivatives. The fair value of the
newly issued common shares associated with the Convertible Notes conversion relative to the carrying value of the debt and fair value of premium conversion derivatives on the conversion date was $ 2.7 million lower and was recorded largely as a gain on note extinguishment in the amount of $ 2.4 million in the accompanying consolidated statements of comprehensive loss with the remaining portion of $ 0.3 million differential being recorded as additional paid-in capital for the portion attributed to related parties.
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Notes to Consolidated Financial Statements
Prior to the conversion of the Convertible Notes, the Company amended the Convertible Notes (the “Conversion Agreement”) on June 8, 2020. Under the Conversion
Agreement, upon such date selected by the Company following Rexahn’s receipt of the required Rexahn stockholder vote and prior to the effectiveness of the Merger, each Convertible Note would automatically and without any action required by any
purchaser or the Company be cancelled and, simultaneously with such cancellation, would convert into that number of fully paid and non-assessable shares of the Company’s common stock that was equal to 175 % times the outstanding principal and accrued but unpaid interest (Note Value) divided by the conversion price (the “Conversion Price”), rounded to the nearest whole
share. The Conversion Price had the meaning of the per share price resulting from the quotient of (1) $ 100,000,000 less the aggregate
amount of 175 % times the Note Value of all of the Convertible Notes divided by (2) the fully diluted shares (the “Fully Diluted
Shares”). Fully Diluted Shares had the meaning of: (1) all of the issued outstanding shares of the Company’s common stock; and (2) the aggregate number of shares of the Company’s common stock reserved for issuance under all outstanding options or
other awards under equity incentive plans of the Company in effect as of such date of determination.
The addition of the new conversion feature under the Conversion Agreement represented a substantial modification to the Convertible Notes, and as such, the Company
recorded the modification as a note extinguishment. On the modification date, the fair value of the Convertible Notes (inclusive of the embedded features) was $ 1.3 million lower upon modification than the aggregate of the carrying value of the Convertible Notes and the fair value of the embedded features; the difference was recorded as a gain on
note extinguishment in the accompanying consolidated statements of comprehensive loss for the year ended December 31, 2020.
Lastly, an increase to additional paid-in capital in the amount of $ 1.0
million was recorded in connection with the Conversion Agreement to account for the excess of the Convertible Notes’ fair value over the aggregate value of outstanding note principal, accrued interest and fair value of the premium conversion
derivatives upon execution of the Conversion Agreement.
The Convertible Notes accrued interest at a rate of 8 %
per annum, calculated on a 365-day year basis. Interest expense on principal during the year ended December 31, 2020 was $ 0.5 million.
Previous to the Conversion Agreement, the outstanding principal of, and accrued interest on the Convertible Notes were payable on demand, in the absence of the
Merger closing discussed above, at any time as of the first to occur of (i) September 30, 2020 or (ii) an event of default (each defined by the Convertible Notes as a Payoff Event). If, prior to a Payoff Event, the Company (i) completed an
initial public offering (“IPO”), (ii) completed a change in control (“CIC”), (iii) completed a sale and issuance of its capital stock resulting in gross proceeds to the Company of at least $ 5 million (“Qualified Financing”), or (iv) completed a reverse merger transaction (Reverse Merger), then the outstanding principal of, and accrued but unpaid interest on the Convertible
Notes would have automatically converted upon the earliest of such events to occur as follows:
•
IPO: The Convertible Notes would have automatically converted into the number of fully paid and non-assessable shares of the Company’s common stock equal to One Hundred and Seventy-Five Percent ( 175 %) times Note Value divided by the per share price such shares were issued to purchasers of the Company’s equity securities in the IPO
rounded to the nearest whole share.
•
CIC: The Convertible Notes would have automatically converted prior to the effectiveness of such CIC into that number of fully paid and non-assessable shares of the Company’s common stock equal
to Two Hundred Percent ( 200 %) of the Note Value divided by the per share price of the Company’s common stock at which the
Company’s common stock was valued in such CIC (after giving effect to such conversion). The Convertible Note holder would have been entitled to the same contractual rights and would have been bound by the same restrictions and obligations
as the other stockholders of the Company in such CIC.
•
Qualified Financing : The Convertible Notes would have automatically converted into that number of fully paid and non-assessable shares of the Company that were issued by the Company in the
Qualified Financing, determined by dividing an amount equal to One Hundred and Seventy-Five Percent ( 175 %) times the Note Value
by the per share price such shares of the Company were issued to purchasers of the Company’s equity securities in the Qualified Financing, rounded to the nearest whole share. The Convertible Note holder would have been entitled to the
same contractual rights and would have been bound by the same restrictions and obligations as the other purchasers of shares in the Qualified Financing. A Qualified Financing was defined as a sale and issuance of capital stock of the
Company (or its successor) in a single transaction or series of related transactions resulting in gross proceeds to the Company of not less than $ 5,000,000
(including new equity investment of at least $ 1,000,000 plus the sum of the outstanding principal amount of the Convertible
Notes being so converted under this provision).
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Notes to Consolidated Financial Statements
•
Reverse Merger (excluding close of Merger with Rexahn) : The Convertible Notes would have automatically converted into that number of fully paid and non-assessable shares of the Combined Company
whose shares were publicly traded in the United States or other jurisdiction following the completion of the Reverse Merger (the “Reverse Merger Parent”), determined by dividing an amount equal to One Hundred and Seventy-Five Percent ( 175 %) times the Note Value divided by the per share price at which such shares were issued by the Reverse Merger Parent in such Reverse
Merger, rounded to the nearest whole share. The Convertible Note holder would have been entitled to the same contractual rights and would have been bound by the same restrictions and obligations as the other stockholders of the Company in
the Reverse Merger.
The Company was not permitted to prepay the Convertible Notes prior to a Payoff Event. The Convertible Notes contained default provisions, and when triggered, the
holders of the Convertible Notes could have immediately accelerated payment of the Convertible Notes and the outstanding principal and interest would have become payable immediately. During a period of default, interest would have been assessed
at a 12 % per annum rate.
Redemption Features
The Company determined that all of the conversion provisions, except for the conversion provision upon Merger close, were redemption features that qualified as
embedded derivatives. The qualifying embedded derivatives were collectively separated from their debt host upon the issuance of the Convertible Notes. The bifurcation of the embedded derivatives from the debt host resulted in a discount to the
Convertible Notes in the amount of $ 0.8 million during the year ended December 31, 2020. The embedded derivatives were accounted for
separately on a fair market value basis. The fair value of the derivatives was $ 2.7 million at December 31, 2020 and was included in
the premium conversion derivatives line item on the accompanying consolidated balance sheets. There were no outstanding premium
conversion derivatives as of December 31, 2021 given the conversion of the Convertible Notes. The Company recorded the fair value changes of the premium conversion derivatives while outstanding to fair value change in derivative and warrant
liabilities in the accompanying consolidated statements of comprehensive loss which amounted to a benefit of $ 0.5 million during the
year ended December 31, 2020.
The Company recorded a discount to the Convertible Notes, attributed to both third party costs in connection with the note extinguishments and note issuance costs,
of $ 8,000 during the year ended December 31, 2020.
The note discounts were amortized to interest expense over the term of the Convertible Notes using the straight-line method which approximates the effective interest
method and amounted to $ 0.9 million during the year ended December 31, 2020.
6.
Related Party Transactions
CVR Agreement
The Company entered into a CVR Agreement with the former Rexahn stockholders. See Note 2 – Merger.
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Notes to Consolidated Financial Statements
Convertible Notes with Related Parties
The Company entered into Convertible Notes with certain investors beginning on May 25, 2018. Through December 31, 2021, Convertible Notes in the principal aggregate
amount equal to $ 0.7 million were issued to four board members and to two officers, one of which was also a board member of the Company. On November 4, 2020, all of Ocuphire’s outstanding Convertible Notes were converted into Ocuphire
common, see Note 5 – Convertible Notes.
Apexian Sublicense Agreement
On January 21, 2020, as amended on June 4, 2020, the Company entered into a sublicense agreement with Apexian Pharmaceuticals, Inc. (“Apexian”) and issued a total of
843,751 shares of common stock to Apexian and to certain affiliates of Apexian. See Note 8 – Apexian Sublicense Agreement.
Pre-Merger Financing
Five directors of Private Ocuphire and one director of Rexahn participated in the Pre-Merger Financing, investing an aggregate of $ 300,000 . Following the closing of the Merger, these directors received 17,729
Converted Initial Shares, 53,189 Converted Additional Shares, 80,366 Series A Warrants and 9,444 Series B Warrants. See Note 9 –
Stockholders’ Equity (Deficit).
Waiver Agreements
Six directors of the Company signed Waiver Agreements,
waiving certain reset provisions financing restrictions. See Note 9 – Stockholders’ Equity (Deficit).
7.
Share-based Compensation
Share-based compensation expense was included in general and administrative and research and development costs as follows in the accompanying statements of
comprehensive loss for the periods indicated below (in thousands):
December 31,
2021
2020
General and administrative
$
1,116
$
675
Research and development
798
831
Total share-based compensation
$
1,914
$
1,506
Ocuphire Stock Options
Inducement Plan
On February 22,
2021, the Company adopted the Ocuphire Pharma, Inc. Inducement Plan (the “Plan”), pursuant to which the Company reserved 325,258
shares of its common stock to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company within
the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules.
2020 Equity Incentive Plan
The stockholders of the Company approved the 2020 Equity Incentive Plan (the “2020 Plan”) for share-based awards. The 2020 Plan became effective on November 5,
2020. Under the 2020 Plan, (i) 1,000,000 new shares of common stock are reserved for issuance and (ii) up to 70,325 additional shares of common stock may be issued, consisting of (A) shares that remain available for the issuance of awards under prior equity
plans and (B) shares of common stock subject to outstanding stock options or other awards covered by prior equity plans that have been cancelled or expire on or after the date that the 2020 Plan became effective. The 2020 Plan permits the grant of incentive and nonstatutory stock
options, appreciation rights, restricted stock, restricted stock units, performance stock and cash awards, and other share‑based awards .
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Notes to Consolidated Financial Statements
2018 Equity Incentive Plan
Prior to the 2020 Plan, the Company had adopted a 2018 Equity Incentive Plan (the “2018 Plan”) in April 2018 under which 1,175,000 shares of the Company’s common stock were reserved for issuance to employees, directors and consultants. Upon the effective date of the 2020 Plan, no additional shares were available for issuance under the 2018 Plan .
During the years ended December 31, 2021 and 2020, 420,300
and 830,167 stock options were granted to newly-hired officers, directors, employees and consultants (as adjusted for the Exchange
Ratio), respectively, generally vesting over an immediate to forty-eight ( 48 ) month period. The Company recognized $ 1.8 million and $ 1.4 million in
share-based compensation expense related to stock options during the years ended December 31, 2021 and 2020, respectively. During the years ended December 31,2021 and 2020, 73,442 and 40,672 stock options were exercised,
respectively, with an intrinsic value of $ 345,000 and $ 175,000 , respectively. The following table summarizes the Company’s stock option plan activity:
Number of
Options
Weighted
Average
Exercise
Price
Weighted Average
Remaining
Contractual
Term (years)
Aggregate
Intrinsic
Value(1)
(in thousands)
Outstanding at December 31, 2019
1,037,705
$
1.06
9.20
$
1,374
Granted
830,167
$
3.50
—
—
Exercised
( 40,672
)
$
—
—
—
Forfeited/Cancelled
( 43,002
)
$
—
—
—
Outstanding at December 31, 2020
1,784,198
$
2.17
8.87
$
7,744
Granted
420,300
$
5.72
—
—
Exercised
( 73,442
)
$
—
—
—
Forfeited/Cancelled
( 34,220
)
$
—
—
—
Outstanding at December 31, 2021
2,096,836
$
2.97
8.20
$
2,795
Vested and exercisable at December 31, 2021
1,281,263
$
1.88
7.63
$
2,370
(1)
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and
the fair value of our common stock as of December 31, 2021 and 2020 of $ 3.73 and $ 6.49 per share (as adjusted for the Exchange Ratio), respectively.
The weighted average fair value per share of options granted during the years ended December 31, 2021 and 2020 was $ 4.36 and $ 3.92 , respectively. The Company measures the fair
value of stock options with service‑based and performance‑based vesting criteria to employees, directors, 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 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 based on the contractual term for agreements that allow for exercise of vested options
through the end of the contractual term upon termination of continuous service, and for all other agreements, was 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.
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Notes to Consolidated Financial Statements
The weighted‑average assumptions used in the Black‑Scholes option‑pricing model are as follows during the years ended December 31, 2021 and 2020:
2021
2020
Expected stock price volatility
98.1
%
86.8
%
Expected life of options (years)
5.8
7.2
Expected dividend yield
0
%
0
%
Risk free interest rate
0.9
%
0.6
%
During the years ended December 31, 2021 and 2020, 468,301
and 379,576 stock options vested (as adjusted for the Exchange Ratio), respectively. The weighted average fair value per share of
options vesting during the years ended December 31, 2021 and 2020 was $ 3.49 and $ 2.77 , respectively. During the years ended December 31, 2021 and 2020, 34,220
and 43,002 stock options were forfeited, respectively. As of December 31, 2021, 890,542 shares in the aggregate were available for future issuance under the 2020 Plan and Inducement Plan.
Unrecognized share‑based compensation cost was $ 2.4
million as of December 31, 2021. The unrecognized share‑based expense is expected to be recognized over a weighted average period of 1.1
years.
Ocuphire Restricted Stock Awards
On November 11, 2020, the Company granted 40,000
restricted stock awards (“RSAs”) that vested on January 8, 2021. There were no RSAs granted during the years ended December 31, 2021.
The share-based compensation expense attributed to the RSAs during each of the years ended December 31, 2021 and 2020 was $ 22,000 and $ 0.1 million, respectively.
A summary of RSA activity is as follows for the years ended December 31, 2021 and 2020:
Number of
Shares
Non-vested at December 31, 2019
—
Granted
40,000
Vested
—
Non-vested at December 31, 2020
40,000
Granted
—
Vested
( 40,000
)
Non-vested at December 31, 2021
—
Common Stock Issued
for Services
The Company granted
stock for services in the amount of 21,414 common shares to two board members who elected to receive their board retainers in the form of stock for services performed during the year ended December 31, 2021. The share-based
compensation related to these services amounted to $ 108,000 during the year ended December 31, 2021.
Former Rexahn Options
Following the closing of the Merger, 123
unexercised and vested options to purchase Common Stock granted under the Rexahn Pharmaceuticals Stock Option Plan, as amended (the “Rexahn 2003 Plan”, and together with the Rexahn 2013 Plan, the “Prior Plans”) were outstanding. As of
December 31, 2021, 82 of the former Rexahn options remained outstanding. During the year ended December 31, 2021, 41 of the former Rexahn options expired. The exercise price related to the outstanding options granted under the Prior Plans was $ 182.40 per share with an average remaining contractual life of 0.5 years.
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Notes to Consolidated Financial Statements
8.
Apexian Sublicense Agreement
On January 21, 2020, as amended on June 4,
2020, the Company entered into a sublicense agreement (the “Sublicense Agreement”) with Apexian, pursuant to which it obtained exclusive worldwide patent and other intellectual property rights that constitute a Ref-1 Inhibitor program relating to
therapeutic applications to treat disorders related to ophthalmic and diabetes mellitus conditions. The lead compound in the Ref-1 Inhibitor program is APX3330, which the Company intends to develop as an oral pill therapeutic to treat diabetic
retinopathy and diabetic macular edema initially, and potentially later to treat wet age-related macular degeneration.
In connection with the Sublicense Agreement, the Company issued a total of 843,751 shares of its common
stock to Apexian and to certain affiliates of Apexian. The share issuance transaction was recorded in the amount of $ 2.1 million as
IPR&D expense for the year ended December 31, 2020 based on the fair market value of the common shares issued since no processes or activities that would constitute a “business” were acquired and none of the rights and underlying assets
acquired had alternative future uses or reached a stage of technological feasibility. Additionally, in accordance with the Sublicense Agreement, the Company was required to pay any balance remaining related to $ 0.4 million of Ref-1 Inhibitor program costs to Apexian following the Company’s listing on a major stock exchange. In December 2020, the Company
paid the remaining Ref-1 Inhibitor program cost balance to Apexian in the amount of $ 0.3 million following the close of the Merger.
The Ref-1 Inhibitor program costs were recorded as research and development expenses in the accompanying statements of comprehensive loss .
The Company also
agreed to make one-time milestone payments under the Sublicense Agreement for each of the first ophthalmic indication and the first diabetes mellitus indication for the Development and Regulatory milestones, and once for each of the Sales
milestones. These milestone payments include (i) payments for specified developmental and regulatory milestones (including completion of the first Phase 2 trial and the first Phase 3 pivotal trial in the United States, and filing and achieving
regulatory approval from the FDA for the first New Drug Application for a compound) totaling up to $ 11 million in the aggregate and
(ii) payments for specified sales milestones of up to $ 20 million in the aggregate, which net sales milestone payments are payable
once, upon the first achievement of such milestone. Lastly, the Company also agreed to make a royalty payment equal to a single-digit percentage of its net sales of products associated with the covered patents under the Sublicense Agreement. If
it is not terminated pursuant to its terms, the Sublicense Agreement shall remain in effect until expiration of the last to expire of the covered patents.
None of the milestone
or royalty payments, outside of the Ref-1 Inhibitor program cost reimbursement, were triggered or deemed probable as of December 31, 2021.
9.
Stockholder Equity (Deficit)
At-The-Market
Program
On February 4, 2021, Ocuphire filed a Form S-3 shelf registration under the Securities Act of 1933 which was declared effective by the SEC on February 12, 2021 (the “2021 Shelf”) under which the
Company may offer and sell, from time to time in its sole discretion, securities having an aggregate offering price of up to $ 125
million. In connection with the 2021 Shelf, on March 11, 2021, Ocuphire entered into a Sales Agreement with JonesTrading Institutional Services LLC (“JonesTrading”) under which the Company may offer and sell, from time to time at its sole
discretion, to or through JonesTrading, acting as agent and/or principal, shares of its common stock having an aggregate offering price of up to $ 40
million (the “2021 ATM”). During the year ended December 31, 2021, 2,778,890 common shares were sold under the 2021 ATM for gross proceeds in the amount
of $ 13.5 million before deducting issuance expenses, including the placement agent’s fees, legal and accounting expenses, in the
amount of $ 0.4 million.
Registered Direct Offering
On June 4, 2021, the Company entered into a placement agency agreement with A.G.P./Alliance Global Partners (“AGP”). Pursuant to the terms of the placement agency agreement, AGP on June 8, 2021
sold an aggregate of 3,076,923 shares of the Company’s common stock and warrants to purchase 1,538,461 shares of the Company’s common stock (the “RDO Warrants”) at an offering price of $ 4.875
per one share and 0.50 RDO Warrants, for gross proceeds of $ 15.0 million, before AGP’s fees and related offering expenses in the amount of $ 1.1 million.
The proceeds were allocated between the relative fair values of common stock and warrants at the sale date. The purchase agreement contains customary representations, warranties and agreements by the Company, customary conditions to
closing, indemnification obligations of the Company, other obligations of the parties and termination provisions. The offering of the Securities (the “Registered Direct Offering”) was made pursuant to the Company’s 2021 Shelf.
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Notes to Consolidated Financial Statements
The RDO Warrants have an exercise price of $ 6.09 per share, are exercisable from the
initial issuance date of June 8, 2021, and will expire five years following the initial issuance date. The fair value of the RDO Warrants was determined
to be $ 6.4 million based on the Black-Scholes pricing model. Input assumptions used were as follows: a risk-free interest rate of
0.8 % ; expected volatility of 99.2 % ; expected life of 5 years ; expected dividend yield of 0 % ; and the underlying fair market of the
common stock. The RDO Warrants were classified in stockholders’ equity (deficit) after considering indexation and settlement rules of ASC 480 and 815 that require that the number of issuable shares are fixed and determinable and other
conditions required for equity treatment. As of December 31, 2021, 1,538,461 RDO Warrants were outstanding.
Subject to limited exceptions, a holder of a RDO Warrant will not have the right to exercise any portion of its RDO Warrants if the holder, together with its affiliates, would beneficially own in
excess of 4.99 % (or, at the election of a holder prior to the date of issuance, 9.99 % ) of the number of shares of the Company’s common stock outstanding immediately after giving effect to such exercise; provided, however, that upon prior notice to the Company, the holder may
increase or decrease the beneficial ownership limitation, provided further that in no event shall the beneficial ownership limitation exceed 9.99 %.
Pre-Merger
Financing
Waiver Agreements
Effective February 3, 2021, each investor that invested in the Pre-Merger Financing (as defined below) entered into a Waiver Agreement with the Company (collectively, the “Waiver Agreements”).
Pursuant to the Waiver Agreements, the investors and the Company agreed to waive certain rights, finalize the exercise price and number of Series A Warrants and Series B Warrants, eliminate certain financing restrictions, extend the term of
certain leak-out agreements, and, in the case of certain investors, grant certain registration rights for the shares underlying the warrants.
The Waiver
Agreements provide for the elimination of the full ratchet anti-dilution provisions, contained in the Series A Warrants (as certain of the anti-dilution provisions had previously caused liability accounting treatment for the Series A Warrants).
Upon the effective date of the Waiver Agreements, the Series A Warrants were reclassified to equity.
Pursuant to the Waiver Agreements, the number of shares underlying all of the Series B Warrants was fixed to 1,708,334 in the aggregate with respect to all investors, eliminating any future resets.
Securities Purchase Agreement
On June 17, 2020, Ocuphire, Rexahn and certain investors entered into a Securities Purchase Agreement, which was amended and restated in its entirety on June 29,
2020 (as amended and restated, the “Securities Purchase Agreement”). Pursuant to the Securities Purchase Agreement, the investors invested a total of $ 21.15
million in cash, including $ 300 ,000 invested by five directors of Private Ocuphire and one director of Rexahn, upon closing of the Merger (the
“Pre-Merger Financing”). Pursuant to the Pre-Merger Financing, (i) Ocuphire issued and sold to the investors shares of Private Ocuphire common stock (the “Initial Shares”) which converted pursuant to the exchange ratio in the Merger into an
aggregate of approximately 1,249,996 shares (the “Converted Initial Shares”) of common stock, (ii) Ocuphire deposited into escrow, for
the benefit of the Investors, additional shares of Private Ocuphire common stock (the “Additional Shares”) which converted pursuant to the exchange ratio in the Merger into an aggregate of approximately 3,749,992 shares of common stock (the “Converted Additional Shares”), which Converted Additional Shares were delivered (or became deliverable) to the investors on November
19, 2020, and (iii) the Company agreed to issue to each investor on the tenth trading day following the consummation of the Merger (x)
Series A Warrants representing the right to acquire shares of common stock equal to the sum of (A) the Converted Initial Shares purchased by the investor, (B) the Converted Additional Shares delivered or deliverable to the investor, without
giving effect to any limitation on delivery contained in the Securities Purchase Agreement and (C) the initial number of shares of common stock, if any, underlying the Series B Warrants issued to the Investor and (y) additional warrants to
purchase shares of common stock.
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Notes to Consolidated Financial Statements
Series A Warrants
The Series A Warrants were issued on November 19, 2020 at an initial exercise price of $ 4.4795 per share, were immediately exercisable upon issuance and have a term of five years from the date of issuance. The Series A Warrants are exercisable for 5,665,838 shares of common stock in the
aggregate (without giving effect to any limitation on exercise contained therein) and were outstanding as of December 31, 2021.
The Series A Warrants provide that, until the second anniversary of the date on which all shares of common stock issued and issuable to the investors may be sold
without restriction or limitation pursuant to Rule 144, if Ocuphire publicly announces, issues or sells, enters into a definitive, binding agreement pursuant to which Ocuphire is required to issue or sell or is deemed, pursuant to the provisions
of the Series A Warrants, to have issued or sold, any shares of common stock for a price per share lower than the exercise price then in effect, subject to certain limited exceptions, then the exercise price of the Series A Warrants will be
reduced to such lower price per share. Further, on each Reset Date (as defined below under Series B Warrants ) the Series A Warrants will be adjusted downward (but not increased) such that the exercise price thereof becomes 120 % of the Reset Price (as defined below), and the number of shares underlying the Series A Warrants will be increased (but not decreased) to the
quotient of (a) (i) the exercise price in effect prior to such Reset (as defined below under Series B Warrants) multiplied by (ii) the number of shares underlying the Series A Warrants prior to the Reset divided by (b) the resulting exercise
price. In addition, the exercise price and the number of shares of Common Stock issuable upon exercise of the Series A Warrants will also be subject to adjustment in the event of any stock splits, dividends or distributions or other similar
transactions.
The
Series A Warrants were initially accounted for and classified as liabilities upon close of the Merger through the date of the Waiver Agreements given that certain price reset provisions existed that cannot be used for a fair valuation under a
fixed for fixed settlement scenario required for equity balance sheet classification. A Monte Carlo simulation model was used to estimate the aggregate fair value of the Series A Warrants. Input assumptions used were as follows: risk-free
interest rate 0.4 %; expected volatility of 83.6 %; expected life of 5 years ; and expected dividend yield zero percent. The underlying stock price used was the market price as quoted on Nasdaq as of November 19, 2020. The aggregate fair value of the
Series A Warrants of $ 25.8 million upon issuance was recorded as a long-term liability on the accompanying consolidated balance
sheets. The amount by which the aggregate fair value of the Series A Warrants exceeded the $ 21.15 million gross proceeds from the
Pre-Merger Financing, or $ 4.7 million, was recorded as day- one interest on the accompanying consolidated statements of comprehensive loss during the year ended December 31, 2020. The Company recorded the fair value change of the
Series A Warrants in the amount of $ 2.1 million to the fair value change in derivative and warrant liabilities line item on the
accompanying consolidated statements of comprehensive loss for the year ended December 31, 2020.
Upon the February 3, 2021 effective date of the Waiver Agreements, the Series A Warrants were reclassified to equity. A final fair valuation of the Series A Warrants was performed
utilizing a Black Scholes model to estimate the aggregate fair value of the Series A Warrants prior to being re-classified as equity. Input assumptions used were as follows: risk-free interest rate 0.4 %; expected volatility of 86.6 %;
expected life of 4.8 years; and expected dividend yield zero percent. The underlying stock price used was the market price as quoted on Nasdaq as of February 3, 2021, the effective date of the Waiver Agreement. The fair
value change of the Series A Warrants was $ 33.8 million and was recorded to the fair value change in warrant liabilities and
premium conversion derivatives line item on the accompanying consolidated statements of comprehensive loss for the year ended December 31, 2021. As a result of the reclassification to equity, the Series A Warrants are no longer subject to
remeasurement.
Series B Warrants
The Series B Warrants have an exercise price of $ 0.0001 ,
were exercisable upon issuance and will expire on the day following the later to occur of (i) the Reservation Date (as defined therein), and (ii) the date on which the investor’s Series B Warrants have been exercised in full (without giving
effect to any limitation on exercise contained therein) and no shares remain issuabl e thereunder. The Series B Warrants are fixed and were exercisable for 1,708,334 shares of Common Stock, as of the effective date of the Waiver Agreement, in the aggregate (without giving effect to any limitation on exercise contained
therein). In April 2021, investors exercised Series B Warrants for a total of 1,629,634 shares. As of December 31, 2021, 78,700 Series B warrants were outstanding.
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Notes to Consolidated Financial Statements
Prior to the Waiver Agreements, the Series B warrants were initially exercisable for 665,836 shares of Common Stock in the aggregate (without giving effect to any limitation on exercise contained therein). Additionally, prior to the Waiver Agreement, the number of Series B were subject to
adjustment whereby every ninth trading day up to and including the 45 th trading day (each, a “Reset Date”) following (i) six months
following the issuance date (the “ Six Month Reset Date”) and (ii) if a Public Information Failure has occurred at any time following
the Six Month Reset Date, the earlier to occur of (x) the date that such Public Information Failure is cured and no longer prevents
the holder from selling all underlying securities pursuant to Rule 144 without restriction or limitation and (y) the earlier to occur of (I) the date all of the underlying securities may be sold without restriction or limitation pursuant to Rule
144 and without the requirement to be in compliance with Rule 144(c)(1) and (II) one year after the issuance date (each such date
provided in the foregoing clauses (i), (ii) and (iii), an “End Reset Measuring Date”) (such 45 trading day period, the Reset Period
and each such 45 th trading day after an End Reset Measuring Date, an “End Reset Date”), the number of shares issuable upon exercise of
each Investor’s Series B Warrants shall be increased (a “Reset”) to the number (if positive) obtained by subtracting (i) the sum of (a) the number of Converted Initial Shares issued to the investor and (b) the number of Converted Additional
Shares delivered or deliverable to the investor as of the Warrant Closing Date, from (ii) the quotient determined by dividing (a) the pro rata portion of the Purchase Price paid by the Investor, by (b) the greater of (x) the arithmetic average of
the five lowest dollar volume-weighted average prices of a share of Common Stock on Nasdaq during the applicable Reset Period immediately preceding the applicable Reset Date to date and (y) a floor price per share calculated based on a pre-money
valuation (of the Combined Company, assuming for this purpose the pre-money issuance of the Converted Initial Shares and Converted Additional Shares) of $ 10
million.
The Series B
Warrants were accounted for and classified as equity on the accompanying consolidated balance sheets.
Other
In connection with the Pre-Merger Financing, the Company incurred issuance costs in the amount of $ 1.8 million which included (i) a placement agent cash fee of $ 1.6
million and (ii) legal and other fees of $ 0.2 million. Issuance costs in the amount of $ 0.7 million attributed to the Series A Warrants were recorded as interest expense on the accompanying consolidated statements of comprehensive loss for the year ended
December 31, 2020 and $ 1.1 million was recorded as an offset to additional paid-in capital.
10. Collaboration and License Agreements
BioSense License and Assignment Agreement
On March 10, 2020, pre-Merger, Rexahn entered into an amendment to its collaboration and license agreement, (as amended, the “BioSense License
and Assignment Agreement”) with BioSense to advance the development and commercialization of RX-3117 for all human uses in the Republic of Singapore, China, Hong Kong, Macau, and Taiwan (the “BioSense Territory”). Under the terms of the BioSense
License and Assignment Agreement, the Company (i) granted BioSense an exclusive license to develop and commercialize pharmaceutical products containing RX-3117 as a single agent for all human uses in the BioSense Territory and (ii) assigned and
transferred all of the former Rexahn patents and patent applications related to RX-3117 in the BioSense Territory. The upfront payment consisted of an aggregate of $ 1,650,000 , of which $ 1,550,000 was paid to Rexahn prior to the Merger.During
the year ended December 31, 2021, the Company satisfied a performance obligation for the $ 100,000 payment that was remaining and
recorded this amount as collaboration revenue.
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Notes to Consolidated Financial Statements
Under the BioSense
License and Assignment Agreement, the Company is eligible to receive additional milestone payments in an aggregate of up to $ 84,500,000
upon the achievement of development, regulatory and commercial goals and will also be eligible to receive tiered royalties at low double-digit rates on annual net sales in the BioSense Territory. The Company determined that none of the milestone
payments under the BioSense License and Assignment Agreement were probable of payment as of December 31, 2021, and as a result, no
revenue related to the milestones was recognized as the achievement of events entitling the Company to any milestone payments were highly susceptible to factors outside of the Company’s control. Future sales-based royalties related to the
exclusive license to develop RX-3117 will be recognized in the period the underlying sales transaction occurs.
Payments received
under the BioSense License and Assignment Agreement are subject to the CVR Agreement described in Note 2 – Merger.
Processa License Agreement
On June 16, 2021, the
Company entered into a license agreement (the “Processa License Agreement”) with Processa Pharmaceuticals, Inc. (“Processa”), pursuant to which the Company has agreed to grant Processa an exclusive license to develop, manufacture and
commercialize RX-3117 globally, excluding the BioSense Territory.
As consideration for the Processa License Agreement, the Company received an upfront payment in July 2021 consisting of 44,689 shares of Processa common stock with a fair value of $ 289,000 (at the contract date) and a $ 200,000 cash payment.The Company is
restricted from selling the Processa common stock for a period of one year ending June 16, 2022. As additional consideration, Processa
will make payments to the Company upon the achievement of certain development and regulatory milestones, which primarily consist of dosing a patient in pivotal trials or having a drug indication approved by a regulatory authority in the United
States or another country. In addition, Processa will pay the Company mid-single-digit royalties based on annual sales under the license and will make one -time
sales milestone payments based on the achievement during a calendar year of certain thresholds for annual sales. Processa is also required to give the Company 32 % of any milestone payments received based on any sub-license agreement Processa may enter into with respect to the Processa License Agreement.The Company determined that none of the
milestone payments under the Processa License Agreement were probable of payment as of December 31, 2021, and as a result, no revenue
related to the milestones was recognized, as the achievement of events entitling the Company to any milestone payments were highly susceptible to factors outside of the Company’s control.
Processa is required to use commercially reasonable efforts, at its sole cost and expense, to conduct development activities in one or more countries, including meeting specific diligence milestones that consist of: (i) first patient administered drug in a clinical trial of a
licensed product prior to the three ( 3 ) year anniversary of the effective date; and (ii) first patient administered drug in a pivotal
clinical trial of a licensed product or first patient administered drug in a clinical trial for a second indication of a licensed product prior to the five ( 5 ) year anniversary of the effective date. Either party may terminate the agreement in the event of a material breach of the agreement that has not been cured following written notice and
a 120 -day opportunity to cure such breach, and Processa may terminate the agreement for any reason upon 120 days prior written notice to Ocuphire.
As of December 31,
2021, the Company has fulfilled its performance obligations with respect to the upfront payment under the Processa License Agreement and has recognized the associated licensing revenue in connection with the payment.
Payments received
under the Processa License Agreement will be subject to the CVR Agreement described in Note 2 – Merger.
11.
Net loss per share
Basic loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period.
Diluted earnings or loss per share of common stock is computed similarly to basic earnings or loss per share except the weighted average shares outstanding are increased to include additional shares from the assumed exercise of any common stock
equivalents, if dilutive. The Company’s warrants, convertible notes, restricted stock awards and stock options while outstanding are considered common stock equivalents for this purpose. Diluted earnings is computed utilizing the treasury
method for the warrants, restricted stock and stock options. No incremental common stock equivalents were included in calculating diluted loss per share because such inclusion would be anti-dilutive given the net loss reported for the periods
presented. The historical share and per share data for periods on or prior to the November 5, 2020 close of the Merger have been adjusted to give effect to the Exchange Ratio.
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Notes to Consolidated Financial Statements
The following potential common shares were not considered in the computation of diluted net loss per share as their effect would have been anti-dilutive for the year
end periods presented below:
2021
2020
Series A, Series B and RDO warrants
7,282,999
6,331,674
Stock options
2,096,836
1,784,198
Restricted stock awards including pending issuances of stock for services
6,970
40,000
Former Rexahn warrants
66,538
66,538
Former Rexahn options
82
123
12.
Income Taxes
The effective tax rate for the years ended December 31, 2021 and 2020 was zero percent.
A reconciliation of income tax computed at the statutory federal income tax rate to the provision (benefit) for income taxes included in the accompanying statements
of comprehensive loss is as follows for the years ended December 31, 2021 and 2020:
2021
2020
Income tax (benefit) provision at federal statutory rate
( 21.0
)%
( 21.0
)%
Valuation allowance
11.9
13.8
State income tax, net of federal benefit
( 4.8
)
( 4.7
)
Acquired in-process research and development expense
—
8.8
Warrants
15.3
7.6
Convertible notes
—
( 3.3
)
Stock options
( 0.1
)
( 0.1
)
Research and development
( 1.1
)
( 1.1
)
Other
( 0.2
)
—
Effective tax rate
—
%
—
%
Significant components of the Company’s deferred tax assets and liabilities are summarized in the tables below as of December 31, 2021 and 2020:
2021
2020
Deferred tax assets:
Federal and state operating loss carryforwards
$
19,244
$
3,351
Acquired intangibles
547
547
Organizational costs
7
8
Other
18
—
Share-based compensation
811
466
Research and development
1,035
275
Subtotal
21,662
4,647
Valuation allowance
( 21,662
)
( 4,647
)
Total deferred tax assets, net of valuation allowance
—
—
Deferred tax liabilities:
Total deferred tax liabilities
—
—
Net deferred tax assets
$
—
$
—
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Notes to Consolidated Financial Statements
As of December 31, 2021 and 2020, the Company had gross deferred tax assets of approximately $ 21.7 million and $ 4.6 million, respectively. Realization of the
deferred assets is primarily dependent upon future taxable income, if any, the amount and timing of which are uncertain. The Company has had significant pre‑tax losses since its inception. The Company has not yet generated revenues and faces
significant challenges to becoming profitable. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance of $ 21.7
million and $ 4.6 million as of December 31, 2021 and 2020, respectively. U.S. net deferred tax assets will continue to require a
valuation allowance until the Company can demonstrate their realizability through sustained profitability or another source of income.
As of December 31, 2021 and 2020, the tax effect of the Company’s federal net operating loss carryforwards was approximately $ 15.7 million and $ 2.7 million,
respectively. The Company had federal research credit carryforwards as of December 31, 2021 and 2020 of approximately $ 1.0 million and
$ 0.3 million, respectively. The federal net operating loss carryforwards will not expire and the tax credit carryforwards will begin to
expire in 2040 if not utilized. As of December 31, 2021 and 2020, the Company had state net operating loss carryforwards with a tax effect of approximately $ 3.6 million and $ 0.6 million, respectively. The Company did no t have any state research credit carryforwards as of December 31, 2021 and 2020. The state net operating loss carryforwards will begin to expire in 2028.
Utilization of the net operating loss carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by
Section 382 and Section 383 of the Internal Revenue Code of 1986, as amended, and similar state provisions. Generally, in addition to certain entity reorganizations, the limitation applies when one or more “5-percent shareholders” increase their
ownership, in the aggregate, by more than 50 percentage points over a 3 year testing period, or beginning the day after the most recent ownership change, if shorter. The annual limitation may result in the expiration of net operating losses and
credits before utilization. As a result of the Merger, the Company recorded deferred tax assets of $ 10.3 million relating to net
operating loss carryforwards which were fully offset by a valuation allowance. The $ 10.3 million net deferred tax assets recorded in
relation to the Merger did not include federal and state net operating loss carryforwards that were estimated to expire under Internal Revenue Code Sections 382 as a result of the Merger. The Company has not yet evaluated the impact of Section
382 and Section 383 on its remaining tax attributes that were generated by Ocuphire since the formation of the Company in 2018.
The Company recognizes interest and/or penalties related to uncertain tax positions in income tax expense. There were no uncertain tax positions as of December 31, 2021 and 2020, and as such, no interest or penalties were recorded to income tax expense.
The Company’s corporate returns are subject to examination for the beginning with the 2018 tax year for both federal income tax purposes and for state income tax
purposes in one state jurisdiction.
13.
Subsequent Events
2020 Plan Evergreen Provision
Under the 2020 Plan, the shares reserved automatically increase on January 1 of each year, for a period of not more than ten years from the date the 2020 Plan is approved by the stockholders of the Company, commencing on January 1, 2021 and ending on (and including)
January 1, 2030, by an amount equal to 5 % of the shares of common stock outstanding as of December 31st of the preceding calendar
year. Notwithstanding the foregoing, the Board of Directors may act prior to January 1st of a given year to provide that there will be no January 1 increase in the share reserve for such year or that the increase in the share reserve for such
year will be a lesser number of shares of common stock than would otherwise occur pursuant to the preceding sentence. On January 1, 2022, 942,291
shares were added to the 2020 Plan as a result of the evergreen provision.
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Notes to Consolidated Financial Statements
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
OCUPHIRE PHARMA, INC.
Dated: March 24, 2022
By:
/s/ Mina Sooch
Mina Sooch
President, Chief Executive Officer and Director
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated.
By
/s/ Mina Sooch
Date: March 24, 2022
Mina Sooch
President, Chief Executive Officer and Director
By
/s/ Amy Rabourn
Date: March 24, 2022
Amy Rabourn
Vice President of Finance
By
/s/ Sean Ainsworth
Date: March 24, 2022
Sean Ainsworth
Director
By
/s/ James S. Manuso
Date: March 24, 2022
James S. Manuso
Director
By
/s/ Cam Gallagher
Date: March 24, 2022
Cam Gallagher
Director
By
/s/ Jay Pepose
Date: March 24, 2022
Jay Pepose
Director
By
/s/ Richard J. Rodgers
Date: March 24, 2022
Richard J. Rodgers
Director
By
/s/ Susan K. Benton
Date: March 24, 2022
Susan K. Benton
Director
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.