UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549

Form 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended June 30, 2022

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934

For the transition period from                to ________

Commission File Number: 001-34079
 
Ocuphire Pharma, Inc.
(Exact name of Registrant as specified in its charter)

Delaware
 
11-3516358
(State or Other Jurisdiction of Incorporation or Organization)
 
(I.R.S. Employer Identification Number)

 
37000 Grand River Avenue, Suite 120
Farmington Hills, MI
 
48335
(Address of Principal Executive Offices)
 
(Zip Code)

Registrant’s Telephone Number, Including Area Code: (248) 681-9815
 
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class
 
Trading Symbol(s)
 
Name of Each Exchange on Which Registered
Common Stock, $0.0001 par value per share

OCUP
 
The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer
Non-accelerated filer
Accelerated filer
Smaller reporting company

   
Emerging growth company


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

The number of outstanding shares of the registrant’s common stock as of August 9, 2022 was 20,579,779.



OCUPHIRE PHARMA, INC.
FORM 10-Q
INDEX
 
 
 
Page
 
3
Item 1.
3
 
3
 
4
 
5
 
6
 
7
Item 2.
17
Item 3.
27
Item 4.
27
 
 

 
28
 
 

Item 1.
28
Item 1A.
28
Item 2.
28
Item 3.
28
Item 4.
28
Item 5.
28
Item 6.
29
 
 

30
 
2

PART I – FINANCIAL INFORMATION

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

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

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.

5

 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

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.
 
7

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 not 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.
 
8

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
   
$
 

9

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.
 
10

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

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

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.
Stockholders’ 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

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

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 not 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. During the three and six months ended June 30, 2022, 82 and 123 options expired.

15

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 1st, 2021, the Company began offering a 401(k) plan (“401K Plan”) to its employees. All employees are eligible to participate in the 401K 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 401K Plan, respectively.
 
16

Ocuphire Pharma, Inc.
Form 10-Q

Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion of our financial condition and results of operations should be read in conjunction with the financial statements and notes included in Part I “Financial Information”, Item I “Financial Statements” of this Quarterly Report on Form 10-Q (the “Report”) and the audited financial statements and related footnotes included in our Annual Report on Form 10-K for the year ended December 31, 2021.

Forward-Looking Statements

Certain statements contained in this Report are not statements of historical fact and are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements give current expectations or forecasts of future events or our future financial or operating performance. We may, in some cases, use words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements.

These forward-looking statements reflect our management’s beliefs and views with respect to future events, are based on estimates and assumptions as of the date of this Report and are subject to risks and uncertainties, many of which are beyond our control, that could cause our actual results to differ materially from those in these forward-looking statements. We discuss many of these risks in greater detail under Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent reports filed with or furnished to the Securities and Exchange Commission (the “SEC”). Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

Any forward-looking statement made by us in this Report speaks only as of the date hereof or as of the date specified herein. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable laws or regulations.
 
Overview

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.

Its 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. As a result, Nyxol can potentially be used for the treatment of multiple indications such as reversal of pharmacologically-induced mydriasis (“RM”) (dilation of the pupil), presbyopia (age-related blurry near vision) and dim light or night vision disturbances (“NVD”) (halos and glares). Ocuphire’s management believes these multiple indications potentially represent a significant market opportunity. Nyxol has been studied in a total of 12 clinical trials (3 Phase 1, 5 Phase 2, 4 Phase 3) in a total of approximately 1,100 patients (with over 650 Nyxol-treated) and has demonstrated promising clinical data for use in the multiple ophthalmic indications mentioned above. Ocuphire reported positive top-line data from the 1st Phase 3 trial (MIRA-2) for RM in March 2021, reported positive top-line data from a 2nd Phase 3 RM trial (MIRA-3) in March 2022, reported positive data from a pediatric safety study (MIRA-4) for RM in April 2022, and Ocuphire reported positive top-line data from a Phase 3 trial of Nyxol for treatment of NVD in May 2022. Ocuphire also reported positive top-line data from a Phase 2 trial of Nyxol for treatment of presbyopia, both alone and with low-dose pilocarpine (pilocarpine hydrochloride 0.4% ophthalmic solution, “LDP”) as adjunctive therapy in June 2021 and January 2022. Ocuphire anticipates submitting a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in late 2022 under the 505(b)(2) pathway for its drug-led combination product. Ocuphire has started pre-commercialization planning and activities in anticipation of approval of its RM application.

Ocuphire’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. DR is a disease resulting from diabetes in which chronically elevated blood sugar levels cause progressive damage to blood vessels in the retina. DME is a severe form of DR which involves leakage of protein and fluid into the macula, the central portion of the retina, causing swelling and vascular damage. Prior to Ocuphire’s in-licensing of the product candidate, APX3330 had been studied by other sponsors in a total of 11 clinical trials (6 Phase 1 and 5 Phase 2) in a total of over 420 healthy volunteers or patients (with over 340 APX3330-treated) for inflammatory and oncology indications, and had demonstrated evidence of tolerability, pharmacokinetics, durability, and target engagement. Ocuphire has also in-licensed APX2009 and APX2014, which are second-generation product candidates and analogs of APX3330. Ocuphire initiated a Phase 2 trial for APX3330 in April 2021 for the treatment of patients with DR, including moderately severe non-proliferative DR (“NPDR”) and mild proliferative DR (“PDR”), as well as patients with DME without loss of central vision. Ocuphire reported enrollment completion of 103 patients in the ZETA-1 trial in March 2022 and expects to report top-line results from the ZETA-1 DR/DME Phase 2b study in the second half of 2022. In July 2022, Ocuphire reported masked safety data as of mid-June 2022, from the ongoing Phase 2 trial in DR/DME for the 103 patients enrolled where 100% of these patients completed 12 weeks of dosing and approximately 70% patients completed 24 weeks of dosing. These masked safety data are consistent with the favorable safety profile from the prior 11 clinical trials with total exposure experience of over 9,000 subject-days with 600 mg daily dose of APX3330.

17

Ocuphire Pharma, Inc.
Form 10-Q
Strategic Outlook

As part of its strategy, Ocuphire will continue to explore opportunities to acquire additional ophthalmic assets and to seek strategic partners for late-stage development, regulatory preparation and commercialization in key global markets. To date, Ocuphire’s primary activities have been conducting research and development activities, planning clinical trials, performing business and financial planning, recruiting personnel and raising capital. Ocuphire does not have any products approved for sale and has not generated any significant amounts of revenue. Ocuphire does not expect to generate significant revenues until, and unless, the FDA or other regulatory authorities approve Nyxol or APX3330 and Ocuphire successfully commercializes its product candidates. Until such time, if ever, as Ocuphire can generate substantial product revenue, Ocuphire expects to finance its cash needs through a combination of equity and debt financings as well as collaborations, strategic alliances and licensing arrangements. Through June 30, 2022, Ocuphire has funded its operations primarily through equity financings that totaled $52.7 million in gross proceeds, of which $21.15 million was received in connection with the merger (“Merger”) with Rexahn Pharmaceuticals, Inc. (“Rexahn”), net cash at Rexahn, a minor amount of license fee payments earned under license agreements related to Rexahn’s RX-3117 drug compound, and through the issuance of convertible notes in private placements that totaled $8.5 million in gross proceeds. Ocuphire’s net losses were $11.5 million and $46.2 million for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, Ocuphire had an accumulated deficit of $100.9 million. Ocuphire anticipates that its expenses will increase substantially as it:
 

continues clinical trials for Nyxol, APX3330 and for any other product candidate in its future pipeline;

continues preclinical studies for Nyxol, APX3330 and for any other product candidate in its future pipeline;

develops additional product candidates that it identifies, in-licenses or acquires;

seeks regulatory approvals for any product candidates that successfully complete clinical trials;

contracts to manufacture its product candidates;

maintains, expands and protects its intellectual property portfolio;

hires additional staff, including clinical, scientific, operational and financial personnel, to execute its business plan;

adds operational, financial and management information systems and personnel, including personnel to support its product development and potential future commercialization efforts;

continues to operate as a public company; and

establishes on its own or with partners, a sales, marketing and distribution infrastructure to commercialize any products for which Ocuphire may obtain regulatory approval;
 
Ocuphire’s net losses may fluctuate significantly from quarter–to quarter and year–to year, depending on the timing of its preclinical studies, clinical trials and its expenditures on other research and development activities as well as level of license fee payments received under license agreements in connection with the former Rexahn drug compounds.

Recent Developments

Clinical Milestones

On May 19, 2022, Ocuphire announced positive top-line results in LYNX-1, a Phase 3 pivotal clinical trial investigating the safety and efficacy of Nyxol for night (or dim light) vision disturbances (NVD) in 145 subjects. The FDA-agreed primary endpoint was met, with a statistically significant greater percentage of Nyxol-treated subjects having gained 15 or more letters of mesopic low contrast distance visual acuity (mLCVA) at Day 8, compared to placebo. Key secondary endpoints were also met, including 10 and 15 or more letters of mLCVA improvement at day 15. Nyxol continued to show a favorable safety and tolerability profile with no serious adverse events, and the low adverse events occurring in Nyxol-treated subjects were predominantly mild in severity and were consistent with those observed in previous trials. This is the first Phase 3 trial to study NVD and to show an improvement in distance and contrast vision at night with a pupil modulation mechanism which has cross-over differentiation to presbyopia.

Non-clinical Update

For presbyopia, the in-life phase of a 90-day nonclinical ocular toxicology study has been completed for Nyxol and LDP doses in Dutch-belted rabbits. This study was designed to support any future chronic indication for such combination.  Reports will be finalized and submitted to the FDA.

Regulatory Update

Previously, Ocuphire completed a Type-C meeting with the FDA on February 14, 2022 from which it obtained guidance regarding the design of VEGA-2 and VEGA-3 pivotal trials for Nyxol both as a single agent and with LDP as adjunct eye drops for the treatment of presbyopia. In addition to the February 2022 Type-C meeting, Ocuphire completed a Type B (Pre-NDA) meeting on June 24, 2022 from which it obtained guidance on the content of CMC, Clinical and Non-Clinical Modules. The FDA confirmed that OraVerse and Regitine were appropriate to use as reference listed drugs to support a 505(b)(2) NDA. In July 2022, Ocuphire submitted a Phase 3 protocol for Study OPI-NYXP-301 (VEGA-2).  This is the first of two Phase 3 registration trials intended to support the presbyopia indication and is anticipated to initiate in the second half of 2022. If successful, the Company expects to file a supplemental NDA for Nyxol as a single-agent for presbyopia and a new NDA for the combination thereafter.

18

Ocuphire Pharma, Inc.
Form 10-Q
Presentations, Publications and Conferences

Ocuphire’s management team and medical advisors have participated by invitation at twenty medical, scientific, industry and investment conferences from January through August 2022, at which over twenty papers, posters and panel talks were presented. The Company has been engaging with dozens of key opinion leaders to expand awareness of the Nyxol and APX3330 development programs.

Patents

On August 3, 2022, Ocuphire announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,400,077, with claims directed to methods of treating mydriasis using phentolamine mesylate. This patent extends patent protection for Nyxol for Reversal of Mydriasis by 5 years into 2039 and is listable in the FDA Orange Book. This new U.S. patent, issued on August 2, 2022, complements the company’s patent estate relating to Nyxol, which contains U.S. and foreign patents and patent applications for phentolamine mesylate formulations and methods of using phentolamine mesylate that include 19 patents and over 30 pending patent applications.

On June 29, 2022, Ocuphire announced that the United States Patent and Trademark Office (USPTO) issued new U.S. patent 11,351,130, which extends the duration of U.S. patent protection for, and broadens coverage of, the company’s late-stage oral product candidate, APX3330. U.S. Patent No. 11,351,130 has claims directed to methods of treatment using APX3330, which makes it eligible for listing in the U.S. FDA Orange Book. It issued on June 7, 2022 and has a term that expires in 2038.  Claims in this patent include methods of treating inflammation and chronic pain in a subject suffering from diabetes. This patent complements the company’s patent estate relating to APX3330 and the company’s pipeline products including APX2009 and APX2014, together the subject of over 40 cases that are a combination of patents and pending patent applications directed to ophthalmic and other uses in the U.S., Europe, Japan, and other foreign countries.

Global Economic Conditions
 
The COVID-19 pandemic that began in late 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.
 
Financial Operations Overview
 
Collaborations Revenue
 
To date, Ocuphire had limited collaborations revenue during the second and third quarters of 2021 related to fees earned from license agreements with BioSense Global LLC (“BioSense”) and Processa Pharmaceuticals, Inc. (“Processa”) in connection with the Rexahn RX-3117 drug compound. We anticipate that we may earn additional revenues stemming from additional milestone and royalty payments from these or other license agreements related to Rexahn’s legacy drug compounds; however, the attainment of milestones or level of sales required to earn royalty payments is highly uncertain.
 
Ocuphire does not expect to generate significant revenue unless or until it obtains regulatory approval of and commercializes Nyxol or APX3330. If Ocuphire fails to complete the development of Nyxol, APX3330, or any other product candidate it may pursue in the future, in a timely manner, or fails to obtain regulatory approval, Ocuphire’s ability to generate significant revenue would be compromised.
 
19

Ocuphire Pharma, Inc.
Form 10-Q
Operating Expenses
 
Ocuphire’s operating expenses are classified into two categories: general and administrative and research and development.
 
General and Administrative
 
General and administrative expenses consist primarily of personnel-related costs, including salaries, benefits and stock-based compensation costs, for personnel in functions not directly associated with research and administrative activities. Other significant costs include insurance coverage for directors and officers and other property and liability exposures, legal fees relating to intellectual property and corporate matters, professional fees for accounting and tax services, and other services provided by business consultants. Ocuphire anticipates that its general and administrative expenses will significantly increase in the future to support its continued research and development activities and costs associated with operating as a public company. These increases will include increased costs related to the hiring of additional personnel and fees for legal and professional services as well as other public company-related costs.
 
Research and Development
 
To date, Ocuphire’s research and development expenses have been related primarily to the clinical-stage development of Nyxol and APX3330. Research and development expenses consist of costs incurred in performing research and development activities, including compensation and benefits for research and development employees and costs for consultants, costs associated with preclinical studies and clinical trials, regulatory activities, manufacturing activities to support clinical activities, license fees, non-legal patent costs, fees paid to external service providers that conduct certain research and development, and an allocation of overhead expenses. Research and development costs are expensed as incurred and costs incurred by third parties are expensed as the contracted work is performed. Ocuphire accrues for costs incurred as the services are being provided by monitoring the status of the study or project, and the invoices received from its external service providers. Ocuphire adjusts its accrual as actual costs become known. Research and development activities are central to Ocuphire’s business model.
 
Ocuphire expects that Nyxol and APX3330 will have higher development costs during their later stages of clinical development, as compared to costs incurred during their earlier stages of development, primarily due to the increased size and duration of the later-stage clinical trials. Ocuphire expects its research and development expenses to significantly increase over the next several years. However, it is difficult for Ocuphire to determine with certainty the duration, costs and timing to complete its current or future preclinical programs and clinical trials of Nyxol, APX3330, and other product candidates. The duration, costs and timing of clinical trials and development of Nyxol, APX3330 and other product candidates will depend on a variety of factors that include, but are not limited to, the following:
 

per patient trial costs;

the number of patients that participate in the trials;

the number of sites included in the trials;

the countries in which the trials are conducted;

the length of time required to enroll eligible patients;

the number of doses that patients receive;

the drop-out or discontinuation rates of patients;

potential additional safety monitoring or other studies requested by regulatory agencies;

the duration of patient follow-up;

the phase of development of the product candidate;

arrangements with contract research organizations and other service providers; and

the efficacy and safety profile of the product candidates.
 
Interest Expense
 
Interest expense consists of interest costs related to interest on principal related to a short-term loan (related to financing an insurance policy) having an annual interest rate of 5.5%.
 
Fair Value Change in Warrant Liabilities
 
The fair value change in warrant liabilities comprises the change in the fair value of the warrant liabilities during the period the warrant liabilities are outstanding.
 
20

Ocuphire Pharma, Inc.
Form 10-Q
Other Income (Expense), net

Other income (expense), 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 when they occur. In addition, payments made by us in connection with the Contingent Value Rights Agreement (the “CVR Agreement”) with former Rexahn shareholders when they occur are also included in this line item.
 
Provision for Income Taxes
 
Provision for income taxes consists of federal and state income taxes in the United States, as well as deferred income taxes and changes in related valuation allowance reflecting the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Currently, there is no provision for income taxes, as Ocuphire has incurred operating losses to date, and a full valuation allowance has been provided on the net deferred tax assets as of June 30, 2022 and December 31, 2021.
 
Results of Operations
 
Comparison of the Three Months Ended June 30, 2022 and 2021
 
The following table summarizes Ocuphire’s operating results for the periods indicated (in thousands):
 
   
For the Three Months Ended
 
   
June 30,
 
   
2022
   
2021
   
Change
 
                   
Collaborations revenue
 
$
   
$
100
   
$
(100
)
                         
Operating expenses:
                       
General and administrative
   
1,776
     
3,408
     
(1,632
)
Research and development
   
3,162
     
3,829
     
(667
)
Total operating expenses
   
4,938
     
7,237
     
(2,299
)
Loss from operations
   
(4,938
)
   
(7,137
)
   
2,199
 
Interest expense
   
(4
)
   
     
(4
)
Fair value change in warrant liabilities
   
     
     
 
Other income, net
   
15
     
1
     
14
 
Loss before income taxes
   
(4,927
)
   
(7,136
)
   
2,209
 
Provision for income taxes
   
     
     
 
Net loss
 
$
(4,927
)
 
$
(7,136
)
 
$
2,209
 

Collaborations Revenue

Collaborations revenue was $0.1 million for the three months ended June 30, 2021. Revenue during the period was derived from the license agreement with BioSense related to certain technology transfers. There was no collaborations revenue recognized during the current year period.
 
General and Administrative Expenses
 
General and administrative expenses for the three months ended June 30, 2022 were $1.8 million compared to $3.4 million for the three months ended June 30, 2021. The $1.6 million decrease was largely attributed to settlement costs incurred with certain investors in the comparable prior year period. General and administrative expenses included $0.3 million in stock-based compensation expense during each of the three-month periods ended June 30, 2022 and 2021.
 
Research and Development Expenses
 
Research and development expenses for the three months ended June 30, 2022 were $3.2 million compared to $3.8 million for the three months ended June 30, 2021. The $0.7 million decrease was primarily attributable to the completion of clinical trials and the timing of manufacturing activities for Nyxol and APX3330. Research and development expenses also included $ 0.2 million in stock-based compensation expense during each of the three-month periods ended June 30, 2022 and 2021.
 
Interest Expense
 
Interest expense for the three months ended June 30, 2022 of $4,000 was comprised of interest on principal related to a short-term loan. There was no interest expense during the comparable prior year period.
 
Fair Value Change in Warrant Liabilities
 
There was a negligible change to the fair value of the warrant liability associated with the Rexahn warrants during the three months ended June 30, 2022 and 2021.
 
21

Ocuphire Pharma, Inc.
Form 10-Q
Other Income, net

During the three months ended June 30, 2022, Ocuphire had other income, net of $15,000 which consisted  of interest income related to cash and cash equivalents of $22,000 and realized currency gains of $2,000, offset in part by unrealized losses from our short-term investments of $9,000. Other income during the three months ended June 30, 2021 was attributed largely to interest income.

Comparison of the Six Months Ended June 30, 2022 and 2021

The following table summarizes Ocuphire’s operating results for the periods indicated (in thousands):
 
   
For the Six Months Ended
 
   
June 30,
 
   
2022
   
2021
    Change  
                   
Collaborations revenue
 
$
   
$
100
   
$
(100
)
                         
Operating expenses:
                       
General and administrative
   
3,512
     
5,112
     
(1,600
)
Research and development
   
7,934