Item 1. Financial Statements
Item 1.
Financial Statements
Ocuphire Pharma, Inc.
Condensed
Balance Sheets
(in thousands, except share amounts and par value)
As of
June 30 ,
2022
December 31,
2021
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
17,025
$
24,534
Prepaids and other current assets
740
1,314
Short-term investments
126
219
Total current assets
17,891
26,067
Property and equipment, net
8
10
Total assets
$
17,899
$
26,077
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
1,886
$
1,584
Accrued expenses
1,418
1,733
Short-term loan
—
538
Total current liabilities
3,304
3,855
Warrant liabilities
—
—
Total liabilities
3,304
3,855
Commitments and contingencies (Note 4 and Note 9)
Stockholders’ equity:
Preferred stock, par value $ 0.0001 ; 10,000,000 shares authorized as of June 30, 2022 and December 31, 2021 ; no shares issued and outstanding at June 30, 2022 and
December 31, 2021 .
—
—
Common stock, par value $ 0.0001 ; 75,000,000 shares authorized as of June 30, 2022 and December 31, 2021 ; 20,099,602 and 18,845,828 shares issued and outstanding at
June 30, 2022 and December 31, 2021 , respectively.
2
2
Additional paid-in-capital
115,483
111,588
Accumulated deficit
( 100,890
)
( 89,368
)
Total stockholders’ equity
14,595
22,222
Total liabilities and stockholders’ equity
$
17,899
$
26,077
See accompanying notes.
3
Index
Ocuphire Pharma, Inc.
Condensed Consolidated
Statements of Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
For the Three Months Ended
June 30,
For the Six Months Ended
June 30,
2022
2021
2022
2021
Collaborations revenue
$
—
$
100
$
—
$
100
Operating expenses:
General and administrative
1,776
3,408
3,512
5,112
Research and development
3,162
3,829
7,934
7,311
Total operating expenses
4,938
7,237
11,446
12,423
Loss from operations
( 4,938
)
( 7,137
)
( 11,446
)
( 12,323
)
Interest expense
( 4
)
—
( 9
)
—
Fair value change of warrant liabilities
—
—
—
( 33,829
)
Other income (expense), net
15
1
( 67
)
2
Loss before income taxes
( 4,927
)
( 7,136
)
( 11,522
)
( 46,150
)
Benefit (provision) for income taxes
—
—
—
—
Net loss
( 4,927
)
( 7,136
)
( 11,522
)
( 46,150
)
Other comprehensive loss, net of tax
—
—
—
—
Comprehensive loss
$
( 4,927
)
$
( 7,136
)
$
( 11,522
)
$
( 46,150
)
Net loss per share:
Basic and diluted (Note 10)
$
( 0.25
)
$
( 0.52
)
$
( 0.60
)
$
( 3.76
)
Number of shares used in per share calculations:
Basic and diluted
19,502,563
13,608,596
19,197,213
12,273,541
See accompanying notes.
4
Index
Ocuphire Pharma, Inc.
Condensed Consolidated Statements of
Changes in Stockholders’ Equity (Deficit)
(in thousands, except share amounts)
(Unaudited)
Common Stock
Additional
Paid–In
Accumulated
Total
Shares
Amount
Capital
Deficit
Equity (Deficit)
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
Stock–based compensation
40,000
—
494
—
494
Exercise of stock options
7,386
—
10
—
10
Net and comprehensive loss
—
—
—
( 39,014
)
( 39,014
)
Balance at March 31, 2021
10,929,881
1
81,504
( 71,689
)
9,816
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
900,943
—
4,067
—
4,067
Issuance of common stock in connection with settlement with investors
350,000
—
1,614
—
1,614
Issuance costs
—
—
( 1,271
)
( 1,271
)
Stock–based compensation
4,474
—
463
—
463
Exercise of Series B warrants
1,629,634
—
—
—
—
Net and comprehensive loss
—
—
—
( 7,136
)
( 7,136
)
Balance at June 30, 2021
16,891,855
$
2
$
101,376
$
( 78,825
)
$
22,553
Balance at December 31, 2021
18,845,828
$
2
$
111,588
$
( 89,368
)
$
22,222
Issuance of common stock in connection with the at-the-market program
336,544
—
1,208
—
1,208
Issuance costs
—
—
( 35
)
—
( 35
)
Stock–based compensation
6,970
—
445
—
445
Exercise of stock options
24,309
—
27
—
27
Net and comprehensive loss
—
—
—
( 6,595
)
( 6,595
)
Balance at March 31, 2022
19,213,651
2
113,233
( 95,963
)
17,272
Issuance of common stock in connection with the at-the-market program
877,927
—
1,858
—
1,858
Issuance costs
—
( 53
)
—
( 53
)
Stock–based compensation
8,024
—
445
—
445
Net and comprehensive loss
—
—
—
( 4,927
)
( 4,927
)
Balance at June 30, 2022
20,099,602
$
2
$
115,483
$
( 100,890
)
$
14,595
See accompanying notes.
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Index
Ocuphire Pharma, Inc.
Condensed Consolidated
Statements of
Cash Flows
(in thousands)
(Unaudited)
Six Months Ended
June 30,
2022
2021
Operating activities
Net loss
$
( 11,522
)
$
( 46,150
)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
890
957
Depreciation
2
2
Fair value change in warrant liabilities
—
33,829
Non-cash share settlement with investors
—
1,614
Unrealized loss from short-term investments
93
—
Change in assets and liabilities:
Collaborations receivable
—
( 50
)
Prepaid expenses and other assets
574
313
Accounts payable
302
161
Accrued and other liabilities
( 318
)
( 816
)
Net cash used in operating activities
( 9,979
)
( 10,140
)
Investing activities
Net cash used in investing activities
—
—
Financing activities
Proceeds from issuance of common stock – registered direct offering
—
15,000
Proceeds from issuance of common stock – at-the-market program
3,066
4,067
Issuance costs
( 85
)
( 1,102
)
Payments in connection with short-term loan
( 538
)
—
Exercise of stock options
27
10
Net cash provided by financing activities
2,470
17,975
Net (decrease) increase in cash and cash equivalents
( 7,509
)
7,835
Cash and cash equivalents at beginning of period
24,534
16,399
Cash and cash equivalents at end of period
$
17,025
$
24,234
Supplemental disclosure of cash flow information:
Cash paid for income taxes
$
—
$
—
Cash paid for interest
$
9
$
—
Supplemental non-cash financing transactions:
Non-cash reclassification of Series A warrant liability to equity
$
—
$
61,793
Unpaid issuance and deferred offering costs
$
3
$
169
See accompanying notes.
6
Index
Notes to Condensed Consolidated Financial Statements
1.
Company Description and Summary of Significant Accounting Policies
Nature of Business
Ocuphire Pharma, Inc. (the "Company" or "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 or through collaborations or partnerships with other companies . 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.
The Company’s headquarters is located in Farmington Hills, Michigan.
Global Economic Conditions
The COVID-19 pandemic that began around December 2019 introduced significant volatility to the global economy,
disrupted supply chains and had a widespread adverse effect on the financial markets. As a result of the COVID-19 pandemic, the Company has experienced, and may 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. Testing and clinical trials, manufacturing, component supply, shipping and research and development operations may be further
impacted by the continuing effects of COVID-19.
The lingering impacts of COVID-19 throughout 2021 and into 2022 have impeded global supply chains and resulted in
inflationary cost increases. These broad-based inflationary impacts may increase future manufacturing costs of our products and product candidates. We expect these inflationary impacts to continue for the foreseeable future.
In addition to the direct and indirect impacts of COVID-19, the United States and global markets are experiencing
volatility and disruption following the escalation of geopolitical tensions and the start of the military conflict between Russia and Ukraine. In February 2022, Russia launched a full-scale military invasion of Ukraine. As a result of the
conflict, the United States, United Kingdom, European Union and other countries have levied economic sanctions and bans on Russia and Russia has responded with its own retaliatory measures. These measures have contributed to significant
volatility and negative pressure in financial markets. Securities of microcap and small-cap companies, including biotechnology companies in particular, have experienced substantial volatility in the recent past, often based on factors
unrelated to the companies’ financial performance or prospects. Further decline in global economic conditions could have a lasting impact on regional and global economies, and may have a material adverse effect on the Company’s results of
future operations, financial position, and liquidity for the duration of fiscal year 2022 and beyond .
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared by the
Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S.
generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations.
The December 31, 2021 condensed balance sheet was derived from audited financial statements,
and may not include all disclosures required by GAAP; however, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed financial statements should be read in
conjunction with the audited financial statements and the notes thereto for the fiscal year ended December 31, 2021.
In the opinion of management, all adjustments, consisting of only normal recurring adjustments
that are necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, have been made. The results of operations for the interim periods are not necessarily indicative of the operating
results for the full fiscal year or any future periods.
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 in the periods presented. Upon close of this merger, the Company did not
have any remaining entities that required consolidation for financial statement reporting purposes. All significant intercompany accounts and transactions were eliminated in the preparation of the condensed financial statements prior to
the December 31, 2021 merger with OcuSub Inc .
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Index
Notes to Condensed Consolidated Financial Statements
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 and debt instruments to finance operating and working capital requirements, including additional issuances under the 2021 at-the-market program
discussed further below. 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 condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and
assumptions that affect the amounts reported in the condensed 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 June 30, 2022, the Company had deposits
that exceeded federally insured amounts by $ 16.5 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 short-term 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
balance sheets. Subsequent changes in fair values are recorded in other income (expense), net on the condensed consolidated statements of comprehensive loss. The Company classifies investments available to fund current operations as
current assets on its balance sheets. The Company did no t recognize any impairments on its investments to date through June
30, 2022.
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 Expenses
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.
Other Income (Expense), net
Other income (expense), net includes payments made by the Company in connection with the
Contingent Value Rights Agreement discussed further below with former stockholders of Rexahn Pharmaceuticals, Inc. (“Rexahn”). In addition, Other income (expense), net includes interest earned from cash and cash equivalent investments,
realized and unrealized gains (losses) from equity investments, and when they occur, reimbursements in connection with grants and other sources.
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Index
Notes to Condensed Consolidated Financial Statements
Stock-Based Compensation
The Company accounts for stock-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. Stock-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 3 – 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 was recognized as a component of the fair value change in warrant liabilities line item in the condensed consolidated statements of comprehensive loss.
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.
As of June 30, 2022 and December 31, 2021, the fair
values of cash and cash equivalents, prepaid and other assets, accounts payable, accrued expenses and short-term loan, while outstanding, approximated their carrying values because of the short-term nature of these assets or liabilities.
The fair value of the short-term 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, 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 six months ended June 30, 2022 and 2021.
The fair value of financial instruments measured on a
recurring basis is as follows (in thousands):
As of June 30, 2022
Description
Total
Level 1
Level 2
Level 3
Assets:
Short-term investments
$
126
$
126
$
—
$
—
Total assets at fair value
$
126
$
126
$
—
$
—
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
$
—
$
—
The following table provides a roll-forward of short-term investments measured at fair value on a recurring basis using observable level
1 inputs for the six months ended June 30, 2022 and 2021 (in thousands):
2022
2021
Short-term investments
Balance as of beginning of period
$
219
$
—
Unrealized loss
( 93
)
—
Balance as of end of period
$
126
$
—
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Index
Notes to Condensed Consolidated Financial Statements
The following table provides a roll-forward of the
warrant liabilities measured at fair value on a recurring basis using unobservable level 3 inputs for the six months ended June 30, 2022 and 2021 (in thousands):
2022
2021
Warrant liabilities
Balance as of beginning of period
$
—
$
27,964
Change in fair value of warrant liabilities
—
33,829
Reclassification of Series A warrants from liability to equity
—
( 61,793
)
Balance as of end of period
$
—
$
—
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 condensed 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 condensed 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
adopted this guidance on January 1, 2022 and it did not have a material impact to our financial statements.
2.
Merger and Contingent Value Rights Agreement
On November 5, 2020, the Company
completed its merger transaction (the “Merger”) with Rexahn. 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 terms of the Merger
and the CVR Agreement, Rexahn stockholders of record as of immediately prior to the effective time of the Merger 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.
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Notes to Condensed Consolidated Financial Statements
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 June 30, 2022, no milestones had been accrued as there were no
additional potential milestones yet considered probable beyond those previously reported in the second and third quarters of calendar year 2021.
Former Rexahn Warrants
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 June 30, 2022, 63,734 of the Rexahn
warrants remained outstanding with exercise prices ranging from $ 38.40 to $ 146.88 per share with an average remaining contractual life of 1.5
years.
3.
Pre-Merger Financing
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 Ocuphire Pharma, Inc., prior to the Merger and one director of Rexahn upon closing of the Merger (the “Pre-Merger Financing”). The Pre-Merger Financing also included the issuance of Series A Warrants and Series B Warrants discussed
further below.
Waiver Agreements
Effective February 3, 2021, each investor that invested in the Pre-Merger Financing 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 in the aggregate with respect to all investors, eliminating
any future resets.
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 June 30, 2022. Prior to the execution of the Waiver Agreements, the Series A Warrants were accounted for and
classified as liabilities on the accompanying condensed balance sheets given certain price reset provisions not used for a fair valuation under a fixed for fixed settlement scenario as required for equity balance sheet classification. 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 line item on the accompanying condensed consolidated statements of comprehensive loss for the six months ended June 30, 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 issuable thereunder. The Series B Warrants outstanding as of June 30, 2022 were exercisable for 78,701 shares of common stock.
The Series B Warrants were accounted for and classified as equity on the accompanying condensed balance sheets.
11
Index
Notes to Condensed Consolidated Financial Statements
4.
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 payments and royalty payments on future
sales (See Note 9 — Apexian Sublicense Agreement). As of June 30, 2022, there was sufficient uncertainty with regard to any future 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 “HQ Lease”) for its operations and headquarters for a seven-month term beginning in June
2019. The HQ 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 HQ Lease and the Rexahn Lease qualified for the short-term lease exception under ASC 842, Leases . The monthly base rent, as amended, for the HQ Lease is approximately $ 3,000 . The monthly base rent for the Rexahn
Lease was $ 13,000 . The rent expense associated with the HQ Lease and Rexahn Lease amounted to $ 9,000 and $ 50,000
during the three months ended June 30, 2022 and 2021, respectively. The rent expense associated with the HQ Lease and Rexahn Lease amounted to $ 21,000 and $ 98,000 during the six months ended June 30, 2022
and 2021, respectively. Total remaining expected rental payments under the HQ Lease amount to $ 18,000 through its December
31, 2022 expiration date .
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 .
5.
Supplemental Balance Sheet Information
Prepaid and Other Assets
Prepaid and other assets consist of the following (in
thousands):
June 30,
2022
December 31,
2021
Prepaids
$
709
$
1,243
Other
31
71
Total prepaids and other assets
$
740
$
1,314
Property and Equipment, net
Property and equipment held for use by category are presented in the
following table (in thousands):
June 30,
2022
December 31,
2021
Equipment
$
20
$
20
Furniture
5
5
Total property and equipment
25
25
Less accumulated depreciation
( 17
)
( 15
)
Property and equipment, net
$
8
$
10
Depreciation
expense was $ 1 ,000 during each of the three month periods ended June 30, 2022 and 2021 and $ 2 ,000 during each of the six month periods ended June 30, 2022 and 2021.
Accrued Expenses
Accrued expenses consist of the following (in thousands):
June 30,
December 31,
2022
2021
R&D services and supplies
$
945
$
1,081
Payroll
330
488
Professional services
104
84
Other
39
80
Total
$
1,418
$
1,733
12
Index
Notes to Condensed Consolidated Financial Statements
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 was payable in six monthly installments of $ 108 ,000
beginning in December 2021. The Loan had an annual interest rate of 5.5 % per annum. Interest expense in the amount of $ 4 ,000 and $ 9 ,000 was
recognized in connection with the Loan during the three and six months ended June 30, 2022. The final payment on the Loan was made in May 2022.
6.
Related Party Transactions
Pre-Merger
Financing and Waiver Agreements
Five directors of Ocuphire Pharma, Inc., prior to the Merger, 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 of common stock, 53,189 converted shares of additional common stock, 80,366
Series A Warrants and 9,444 Series B Warrants. In connection with the Pre-Merger Financing, six directors of the Company signed Waiver Agreements, waiving certain reset provisions and financing restrictions. These directors did not
receive any of the additional Series B Warrants that were issued in connection with the Waiver Agreements. See Note 3 – Pre-Merger Financing.
On April 8, 2022, Ocuphire entered into a consulting agreement with a director of the Company. The consulting
agreement provides for $ 10,000 a month in cash payments, effective as of April 1, 2022. Additionally, on April 8, 2022, in
connection with the consulting arrangement, the director received a stock option grant for 50,000 options, 25 % of which will vest on March 31, 2023, with the remainder vesting in equal monthly installments over 36 months. The Company incurred related consulting expenses of $ 30,000 during the three and six months ended June 30, 2022. There were no related
consulting expenses incurred during the three and six months ended June 30, 2021. $ 10,000 and none of the related consulting expenses were unpaid as of June 30, 2022 and December 31, 2021, respectively .
7.
S tockholders’ Equity
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 three and six months ended June 30, 2022, 877,927 and 1,214,471 shares of common stock were sold under the 2021 ATM for aggregate gross proceeds in the amount of $ 1.9 million and $ 3.1 million,
respectively, before deducting issuance expenses, including the placement agent’s fees, legal and accounting expenses, in the amount of $ 53,000
and $ 88,000 , respectively. During the three and six months ended June 30, 2021, 900,943 shares were sold under the 2021 ATM for gross proceeds in the amount of approximately $ 4.1 million, before deducting issuance expenses in the amount of approximately $ 0.2 million.
Registered Direct Offering
On June 4, 2021, the Company entered into a placement agency agreement for a registered direct offering (“RDO”) 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 approximately $ 15,000,000 , before AGP’s fees and related offering expenses in the amount of approximately $ 1.1 million.
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. As of June 30, 2022, 1,538,461 RDO Warrants were outstanding.
8.
Stock-based Compensation
Stock-based
compensation expense was included in general and administrative and research and development costs as follows in the accompanying condensed consolidated statements of comprehensive loss for the three- and six-month periods indicated below
(in thousands):
Three Months
Ended
June 30,
Six Months
Ended
June 30,
2022
2021
2022
2021
General and administrative
$
276
$
288
$
571
$
481
Research and development
169
175
319
476
Total stock-based compensation
$
445
$
463
$
890
$
957
13
Index
Notes to Condensed Consolidated Financial Statements
Ocuphire Stock Options
Inducement
Plan
On February 22, 2021, the Company adopted the
Ocuphire Pharma, Inc. Inducement Plan (the “Inducement 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 stock-based awards. The 2020 Plan became effective on November 5, 2020. Under the 2020 Plan, (i) 1,000,000
new shares of common stock were 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 net loss
awards, and other stock-based awards.
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.
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.
General
During the three and six months ended June 30, 2022, 174,000 and 726,305 stock
options were granted to directors, officers, employees and consultants, respectively, generally vesting over a twelve ( 12 ) to
forty-eight ( 48 ) month period. During the three and six months ended June 30, 2021, 218,000 and 259,800 stock options were granted to
newly-hired consultants and employees, respectively, generally vesting over a six ( 6 ) to forty-eight ( 48 ) month period. The Company recognized $ 418 ,000 and
$ 434 ,000 in stock-based compensation expense related to stock options during the three months ended June 30, 2022 and 2021,
respectively, and $ 835 ,000 and $ 880 ,000
during the six months ended June 30, 2022 and 2021, respectively. During the six months ended June 30, 2022, 24,309 stock
options were exercised with an intrinsic value of $ 59,000 . During the six months ended June 30, 2021, 7,386 stock options were exercised with an intrinsic value of $ 74,000 .
The weighted average fair value per share of options granted during the
three and six months ended June 30, 2022 was $ 1.71 and $ 2.15 , respectively. The weighted average fair value per share of options granted during the three and six months ended June 30, 2021 was $ 4.50 and $ 4.85 . 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.
14
Index
Notes to Condensed Consolidated Financial Statements
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 midpoint between the vesting date and the end of the contractual term according to the “simplified method” as described in Staff Accounting Bulletin 110. The risk-free interest rate is determined by reference to implied
yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant. The Company records forfeitures when they occur.
The weighted‑average assumptions used
in the Black-Scholes option pricing model are as follows during the three and six months ended June 30, 2022 and 2021:
Three Months
Ended
June 30,
Six Months
Ended
June 30,
2022
2021
2022
2021
Expected stock price volatility
96.2
%
99.2
%
98.8
%
97.2
%
Expected life of options (years)
5.7
5.8
5.9
5.8
Expected dividend yield
0
%
0
%
0
%
0
%
Risk free interest rate
3.3
%
0.9
%
2.1
%
0.9
%
During the three and six months ended June 30, 2022, 204,406 and 267,103 stock options vested, respectively. During the three and six months ended June 30, 2021 , 114,727 and 232,944 stock options vested (as
adjusted for the Exchange Ratio), respectively.
During the three and six months ended June 30, 2022 , 6,000 and 14,288 options were forfeited, respectively. During the three and six months ended June 30, 2021 , 25,558 options were forfeited. As of June 30, 2022, 1,098,645 shares were available for future issuance under the 2020 Plan and Inducement Plan. No
shares were available for future issuance under the 2018 Plan.
Unrecognized
stock-based compensation cost was $ 3.2 million as of June 30, 2022. The unrecognized stock-based expense is expected to be
recognized over a weighted average period of 1.4 years.
Ocuphire Restricted Stock Awards
The Company did no t grant any restricted stock awards (RSAs) during any of the periods
presented. The RSAs granted in previous periods were subject to various vesting schedules. During the six months ended June 30, 2022 and 2021, zero and 40,000 RSAs vested, respectively, and no RSAs were forfeited during the periods presented. The stock-based compensation expense attributed to the RSAs during the six months
ended June 30, 2022 and 2021 was zero and $ 22,000 , respectively.
Common Stock Issued for Services
The Company
granted stock for services in the amount of 14,147 and 4,923 common shares to two board members who
elected to receive their board retainers in the form of stock for services performed during the three months ended June 30, 2022 and 2021, respectively, and 22,171 and 9,397 common shares during the six months ended June 30, 2022 and 2021,
respectively. The stock-based compensation related to these services amounted to $ 27 ,000 and $ 29 ,000 during the three months ended June 30, 2022 and 2021, respectively, and $ 55 ,000 during each of the six months ended June 30, 2022 and 2021.
Former
Rexahn Options
Zero and 123 outstanding,
unexercised and vested options to purchase Common Stock granted under the Rexahn Pharmaceuticals Stock Option Plan, as amended (the “Rexahn 2003 Plan”), remained outstanding as of June 30, 2022 and December 31, 2021, respectively. D uring the three and six months
ended June 30, 2022, 82 and 123
options expired .
15
Index
Notes to Condensed Consolidated Financial Statements
9.
Apexian Sublicense Agreement
On
January 21, 2020, the Company entered into a sublicense agreement (as amended on June 4, 2020, the “Apexian 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 Apexian Sublicense
Agreement, the Company issued a total of 891,422 shares of its common stock to Apexian and to certain affiliates of Apexian
in calendar year 2020. As a result of the common stock issued pursuant to the Apexian Sublicense Agreement, Apexian is considered by Ocuphire to be a related party.
The Company
also agreed to make one-time milestone payments under the Apexian 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 several 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 Apexian Sublicense Agreement. If it is not terminated pursuant to its terms, the Apexian Sublicense Agreement shall remain in effect until expiration of the last to expire of the covered patents.
None of the criteria to recognize
milestone or royalty obligations were met during the three and six month periods ended June 30 , 2022 and 2021.
10.
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, unissued common stock for services and
stock options while outstanding are considered common stock equivalents for this purpose. Diluted earnings are computed utilizing the treasury method for the warrants, unissued common stock for services 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 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 three and six month periods ended presented below:
June 30,
2022
2021
Series A, Series B, and RDO warrants
7,283,000
7,282,999
Stock options
2,784,544
2,011,054
Unissued common stock for services
14,147
4,923
Former Rexahn warrants
63,734
66,538
Former Rexahn options
—
82
11.
Income Taxes
The effective
tax rate for the three and six months ended June 30, 2022 and 2021 was zero percent. As of June 30, 2022, a full valuation
allowance has been established to reduce the Company’s net deferred income tax assets. As such, no tax benefit related to
the Company’s pre-tax loss was recognized for any of the periods presented.
The Company’s corporate returns are subject to examination for tax years beginning in 2018 for federal income tax purposes and subject to examination in various state jurisdictions. The Company does not have any reserves for
income taxes that represent the Company’s potential liability for uncertain tax positions.
12.
Deferred Compensation Plan
Effective October 1 st, 2021, the Company began offering a
401 (k) plan (“ 401 K Plan”) to its employees. All employees are eligible to participate in the 401 K Plan. The Company makes matching contributions equal to 100 % on the first 3 % of compensation that is deferred as an
elective deferral and an additional 50 % on the next 2 % of compensation. The Company’s matching contributions are made on a payroll-by-payroll basis. During the three and six months ended June 30 , 2022, the Company
contributed $ 20,000 and $ 45,000 to the 401 K Plan, respectively.
16
Index
Ocuphire Pharma, Inc.
Form 10-Q
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.