|
|
|
(State or Other Jurisdiction of Incorporation or Organization)
|
(I.R.S. Employer Identification Number)
|
|
|
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
Title of Each Class
|
Trading Symbol(s)
|
Name of Each Exchange on Which Registered
|
||
|
|
|
Large accelerated filer
|
☐ |
|
☒ |
Accelerated filer
|
☐ |
Smaller reporting company
|
|
Emerging growth company
|
|
|
Page
|
|
|
|
Item 1.
|
2
|
|
|
2 |
|
|
3 |
|
|
4 |
|
|
5 |
|
|
6 |
|
Item 2.
|
18 |
|
Item 3.
|
29 |
|
Item 4.
|
29 |
|
|
|
|
|
29 |
|
|
|
|
Item 1.
|
29 |
|
Item 1A.
|
29 |
|
Item 2.
|
29 |
|
Item 3.
|
29 |
|
Item 4.
|
29 |
|
Item 5.
|
29 |
|
Item 6.
|
30 |
|
|
|
|
31 |
Item 1. |
Financial Statements
|
As of
|
||||||||
September 30,
2022
|
December 31,
2021
|
|||||||
(unaudited)
|
||||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Prepaids and other current assets
|
||||||||
Short-term investments
|
|
|
||||||
Total current assets
|
|
|
||||||
Property and equipment, net
|
|
|
||||||
Total assets
|
$
|
|
$
|
|
||||
Liabilities and stockholders’ equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Accrued expenses
|
|
|
||||||
Short-term loan
|
||||||||
Total current liabilities
|
|
|
||||||
Warrant liabilities
|
|
|
||||||
Total liabilities
|
|
|
||||||
Commitments and contingencies (Note 4, Note 9 and Note 10)
|
||||||||
Stockholders’ equity:
|
||||||||
Preferred stock, par value $
|
|
|
||||||
Common stock, par value $
|
|
|
||||||
Additional paid-in-capital
|
|
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Total stockholders’ equity
|
|
|
||||||
Total liabilities and stockholders’ equity
|
$
|
|
$
|
|
For the Three Months Ended
September 30,
|
For the Nine Months Ended
September 30,
|
|||||||||||||||
2022
|
2021
|
2022 | 2021 | |||||||||||||
Collaborations revenue |
$ | $ | $ | $ | ||||||||||||
Operating expenses:
|
||||||||||||||||
General and administrative
|
|
|
||||||||||||||
Research and development
|
|
|
||||||||||||||
Total operating expenses
|
|
|
||||||||||||||
Loss from operations
|
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Interest expense
|
|
|
( |
) | ||||||||||||
Fair value change of warrant liabilities
|
|
|
( |
) | ||||||||||||
Other income (expense), net
|
|
|
( |
) | ||||||||||||
Loss before income taxes
|
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Benefit (provision) for income taxes
|
|
|
||||||||||||||
Net loss
|
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Other comprehensive loss, net of tax
|
|
|
||||||||||||||
Comprehensive loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$ | ( |
) | $ | ( |
) | ||||
Net loss per share:
|
||||||||||||||||
Basic and diluted (Note 11)
|
$
|
(
|
)
|
$
|
(
|
)
|
$ | ( |
) | $ | ( |
) | ||||
Number of shares used in per share calculations:
|
||||||||||||||||
Basic and diluted
|
|
|
Common Stock
|
Additional
Paid–In
|
Accumulated
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Equity (Deficit)
|
||||||||||||||||
Balance at December 31, 2020
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
|||||||||
Reclassification of Series A warrant liability to equity | — | |||||||||||||||||||
Stock–based compensation
|
|
|
|
|
|
|||||||||||||||
Exercise of stock options | ||||||||||||||||||||
Net and comprehensive loss
|
—
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance at March 31, 2021
|
|
|
|
(
|
)
|
|
||||||||||||||
Issuance of common stock and warrants in connection with registered direct offering | ||||||||||||||||||||
Issuance of common stock in connection with the at-the-market program | ||||||||||||||||||||
Issuance of common stock in connection with settlement with investors | ||||||||||||||||||||
Issuance costs | — | ( |
) | ( |
) | |||||||||||||||
Stock–based compensation
|
|
|
|
|
|
|||||||||||||||
Exercise of Series B warrants | ||||||||||||||||||||
Net and comprehensive loss
|
—
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance at June 30, 2021
|
|
|
|
(
|
)
|
|
||||||||||||||
Issuance of common stock in connection with the at-the-market program | ||||||||||||||||||||
Issuance costs |
— | ( |
) | ( |
) | |||||||||||||||
Share–based compensation | ||||||||||||||||||||
Exercise of options |
||||||||||||||||||||
Net and comprehensive loss |
— | ( |
) | ( |
) | |||||||||||||||
Balance at September 30, 2021 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
Balance at December 31, 2021
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Issuance of common stock in connection with the at-the-market program | ||||||||||||||||||||
Issuance costs | — | ( |
) | ( |
) | |||||||||||||||
Stock–based compensation
|
|
|
|
|
|
|||||||||||||||
Exercise of stock options
|
|
|
|
|
|
|||||||||||||||
Net and comprehensive loss
|
—
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance at March 31, 2022
|
|
|
|
(
|
)
|
|
||||||||||||||
Issuance of common stock in connection with the at-the-market program
|
|
|
|
|
||||||||||||||||
Issuance costs
|
— |
|
(
|
)
|
(
|
)
|
||||||||||||||
Stock–based compensation
|
|
|
|
|
|
|||||||||||||||
Net and comprehensive loss
|
—
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance at June 30, 2022
|
|
|
|
(
|
)
|
$
|
|
|||||||||||||
Issuance of common stock in connection with the at-the-market program |
||||||||||||||||||||
Issuance costs |
— | ( |
) | ( |
) | |||||||||||||||
Stock–based compensation |
||||||||||||||||||||
Exercise of Series B warrants |
||||||||||||||||||||
Net and comprehensive loss |
— | ( |
) | ( |
) | |||||||||||||||
Balance at September 30, 2022 |
$ | $ | $ | ( |
) | $ |
Nine Months Ended
September 30,
|
||||||||
2022
|
2021
|
|||||||
Operating activities
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Stock-based compensation
|
|
|
||||||
Depreciation
|
|
|
||||||
Fair value change in warrant liabilities
|
|
|
||||||
Non-cash share settlement with investors
|
||||||||
Receipts of investments related to
license agreement
|
( |
) | ||||||
Unrealized loss (gain) from short-term investments
|
( |
) | ||||||
Change in assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
|
|
||||||
Accounts payable
|
(
|
)
|
|
|||||
Accrued and other liabilities
|
(
|
)
|
(
|
)
|
||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
Investing activities
|
||||||||
Net cash used in investing activities
|
|
|
||||||
Financing activities
|
||||||||
Proceeds from issuance of common stock – registered direct offering | ||||||||
Proceeds from issuance of common stock – at-the-market program
|
||||||||
Issuance costs | ( |
) | ( |
) | ||||
Payments in connection with short-term loan | ( |
) | ||||||
Exercise of stock options and Series B warrants
|
|
|
||||||
Net cash provided by financing activities
|
|
|
||||||
Net (decrease) increase in cash and cash equivalents
|
(
|
)
|
|
|||||
Cash and cash equivalents at beginning of period
|
|
|
||||||
Cash and cash equivalents at end of period
|
$
|
|
$
|
|
||||
Supplemental disclosure of cash flow information:
|
||||||||
Cash paid for income taxes
|
$
|
|
$
|
|
||||
Cash paid for interest
|
$
|
|
$
|
|
||||
Supplemental non-cash financing transactions:
|
||||||||
Non-cash reclassification of Series A warrant liability to equity
|
$
|
|
$
|
|
||||
Unpaid issuance and deferred offering costs
|
$
|
|
$
|
|
1. |
Company Description and Summary of Significant Accounting Policies
|
● |
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 September 30, 2022
|
||||||||||||||||
Description
|
Total
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||
Assets:
|
||||||||||||||||
Short-term investments |
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Total assets at fair value
|
$
|
|
$
|
|
$
|
|
$
|
|
As of December 31, 2021
|
||||||||||||||||
Description
|
Total
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||
Assets:
|
||||||||||||||||
Short-term investments
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Total assets at fair value
|
$
|
|
$
|
|
$
|
|
$
|
|
2022
|
2021
|
|||||||
Short-term investments
|
||||||||
Balance as of beginning of period
|
$
|
|
$
|
|
||||
Receipt of investments related to license agreement | ||||||||
Unrealized (loss) gain
|
(
|
)
|
|
|||||
Balance as of end of period
|
$
|
|
$
|
|
2022
|
2021
|
|||||||
Warrant liabilities
|
||||||||
Balance as of beginning of period
|
$
|
|
$
|
|
||||
Change in fair value of warrant liabilities
|
|
|
||||||
Reclassification of Series A warrants from liability to equity
|
|
(
|
)
|
|||||
Balance as of end of period
|
$
|
|
$
|
|
2. |
Merger and Contingent Value Rights Agreement
|
● |
|
● |
|
● |
|
3.
|
Pre-Merger Financing
|
5. |
Supplemental Balance Sheet Information
|
September 30,
2022
|
December 31,
2021
|
|||||||
Prepaids
|
$
|
|
$
|
|
||||
Other
|
|
|
||||||
Total prepaids and other assets
|
$
|
|
$
|
|
September 30,
2022
|
December 31,
2021
|
|||||||
Equipment
|
$
|
|
$
|
|
||||
Furniture
|
|
|
||||||
Total property and equipment
|
|
|
|
|
||||
Less accumulated depreciation
|
(
|
)
|
(
|
)
|
||||
Property and equipment, net
|
$
|
|
$
|
|
September 30,
|
December 31,
|
|||||||
2022
|
2021
|
|||||||
R&D services and supplies
|
$
|
|
$
|
|
||||
Payroll
|
|
|
||||||
Professional services
|
|
|
||||||
Other
|
|
|
||||||
Total
|
$
|
|
$
|
|
6. |
Related Party Transactions
|
7. |
Stockholders’ Equity
|
8. |
Stock-based Compensation
|
|
Three Months
Ended
September 30,
|
Nine Months
Ended
September 30,
|
||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
||||||||||||
General and administrative
|
$
|
$
|
|
$
|
|
$
|
|
|||||||||
Research and development
|
|
|
|
|
||||||||||||
Total stock-based compensation
|
$
|
|
$
|
|
$
|
|
$
|
|
|
Three Months
Ended
September 30,
|
Nine Months
Ended September 30, |
||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
||||||||||||
Expected stock price volatility
|
|
%
|
|
%
|
|
%
|
|
%
|
||||||||
Expected life of options (years)
|
|
|
|
|
||||||||||||
Expected dividend yield
|
|
%
|
|
%
|
|
%
|
|
%
|
||||||||
Risk free interest rate
|
|
%
|
|
%
|
|
%
|
|
%
|
9. |
Apexian Sublicense Agreement
|
10.
|
Collaboration and License Agreements
|
11. |
Net loss per share
|
September 30,
|
||||||||
2022
|
2021
|
|||||||
Series A, Series B, and RDO warrants
|
|
|
||||||
Stock options
|
|
|
||||||
Unissued common stock for services
|
|
|
||||||
Former Rexahn warrants
|
|
|
||||||
Former Rexahn options
|
|
|
12.
|
Income Taxes
|
13.
|
Deferred Compensation Plan
|
14. |
Subsequent Events
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
• |
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;
|
• |
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.
|
For the Three Months Ended
|
||||||||||||
September 30,
|
||||||||||||
2022
|
2021
|
Change | ||||||||||
Collaborations revenue
|
$
|
—
|
$
|
489
|
$
|
(489
|
)
|
|||||
Operating expenses:
|
||||||||||||
General and administrative
|
1,703
|
1,595
|
108
|
|||||||||
Research and development
|
2,835
|
3,126
|
(291
|
)
|
||||||||
Total operating expenses
|
4,538
|
4,721
|
(183
|
)
|
||||||||
Loss from operations
|
(4,538
|
)
|
(4,232
|
)
|
(306
|
)
|
||||||
Other income, net
|
7
|
2
|
5
|
|||||||||
Loss before income taxes
|
(4,531
|
)
|
(4,230
|
)
|
(301
|
)
|
||||||
Provision for income taxes
|
—
|
—
|
—
|
|||||||||
Net loss
|
$
|
(4,531
|
)
|
$
|
(4,230
|
)
|
$
|
(301
|
)
|
For the Nine Months Ended
|
||||||||||||
September 30,
|
||||||||||||
2022
|
2021
|
Change
|
||||||||||
Collaborations revenue
|
$
|
—
|
$
|
589
|
$
|
(589
|
)
|
|||||
Operating expenses:
|
||||||||||||
General and administrative
|
5,215
|
6,707
|
(1,492
|
)
|
||||||||
Research and development
|
10,769
|
10,437
|
332
|
|||||||||
Total operating expenses
|
15,984
|
17,144
|
(1,160
|
)
|
||||||||
Loss from operations
|
(15,984
|
)
|
(16,555
|
)
|
571
|
|||||||
Interest expense
|
(9
|
)
|
—
|
(9
|
)
|
|||||||
Fair value change in warrant liabilities
|
—
|
(33,829
|
)
|
33,829
|
||||||||
Other (expense) income, net
|
(60
|
)
|
4
|
(64
|
)
|
|||||||
Loss before income taxes
|
(16,053
|
)
|
(50,380
|
)
|
34,327
|
|||||||
Provision for income taxes
|
—
|
—
|
—
|
|||||||||
Net loss
|
$
|
(16,053
|
)
|
$
|
(50,380
|
)
|
$
|
34,327
|
• |
continued clinical trials and preclinical studies for Nyxol, APX3330 and for any other product candidate in its future pipeline;
|
• |
developing additional product candidates that it identifies, in-licenses or acquires;
|
• |
seeking regulatory approvals for any product candidates that successfully complete clinical trials;
|
• |
contracts to manufacture its product candidates;
|
• |
Establishing, on its own or with partners, a sales, marketing and distribution infrastructure to commercialize any products for which it may obtain regulatory approval;
|
• |
maintaining, expanding and protecting its intellectual property portfolio;
|
• |
hiring additional staff, including clinical, scientific, operational and financial personnel, to execute its business plan;
|
• |
adding operational, financial and management information systems and personnel, including personnel to support its product development and potential future commercialization efforts; and
|
• |
operating as a public company.
|
For the Nine Months Ended
|
||||||||
September 30,
|
||||||||
2022
|
2021
|
|||||||
Net cash used in operating activities
|
$
|
(14,477
|
)
|
$
|
(13,724
|
)
|
||
Net cash provided by (used in) investing activities
|
—
|
—
|
||||||
Net cash provided by financing activities
|
3,798
|
19,575
|
||||||
Net (decrease) increase in cash and cash equivalents
|
$
|
(10,679
|
)
|
$
|
5,851
|
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk
|
Item 4. |
Controls and Procedures
|
Item 1. |
Legal Proceedings
|
Item 1A. |
Risk Factors
|
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds
|
Item 3. |
Defaults Upon Senior Securities
|
Item 5. |
Other Information
|
Item 6. |
Exhibits
|
NUMBER
|
DESCRIPTION OF DOCUMENT
|
||
Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Appendix G to the Registrant’s Definitive Proxy Statement on Schedule 14A, filed on April 29, 2005).
|
|||
Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on May 5,
2017).
|
|||
Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on August 30,
2018).
|
|||
Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on April 12,
2019).
|
|||
Certificate of Amendment of Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on November 6, 2020).
|
|||
Certificate of Amendment of Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed on November 6, 2020).
|
|||
Second Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.3 to the Registrant’s Current Report on Form 8-K, filed on November 6, 2020).
|
|||
First Amendment to Second Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 10, 2022).
|
|||
Second Amendment to Second Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 17, 2022).
|
|||
Fourth Lease Amendment, dated as of October 17, 2022.
|
|||
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|||
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|||
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|||
101.INS
|
Inline XBRL Instance Document.
|
||
101.SCH
|
Inline XBRL Taxonomy Extension Schema Document.
|
||
101.CAL
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
|
||
101.DEF
|
Inline XBRL Taxonomy Extension Definition Linkbase Document.
|
||
101.LAB
|
Inline XBRL Taxonomy Extension Label Linkbase Document.
|
||
101.PRE
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
|
||
104
|
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
|
||
*
|
Documents are furnished not filed
|
Dated: November 4, 2022 | ||
Ocuphire Pharma, Inc. | ||
By:
|
/s/ Mina Sooch
|
|
Mina Sooch
|
||
Chief Executive Officer
|
||
(Principal Executive Officer)
|
By:
|
/s/ Amy Rabourn
|
|
Amy Rabourn
|
||
Vice President of Finance
|
||
(Principal Financial Officer)
|