|
||
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(IRS Employer Identification No.)
|
|
||
(Address of principal executive offices)
|
(Zip Code)
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
|
Item 2.02 |
Results of Operations and Financial Condition.
|
Item 9.01. |
Financial Statements and Exhibits.
|
Exhibit
No.
|
Description
|
Press Release, dated August 13, 2024
|
|
104
|
Cover Page Interactive Data File (embedded within the Inline XBRL document)
|
Dated: August 13, 2024
|
OCUPHIRE PHARMA, INC.
|
|
By:
|
/s/ Dr. George Magrath
|
|
Name:
|
Dr. George Magrath
|
|
Title:
|
Chief Executive Officer
|
• |
Data from studies with APX3330 in DR were featured at multiple medical meetings throughout the second quarter, including at the Association for Research in Vision and Ophthalmology Special Interest
Group panel, the American Society of Retina Specialists 42nd Annual Scientific Meeting, the Clinical Trials at the Summit meeting and the Retinal Imaging Biomarkers & Endpoints Summit meeting. Presentations featured results from a subset
analysis that evaluated the efficacy of APX3330 in slowing DR progression using a binocular DR severity person-level scale in high-risk non-proliferative DR patients.
|
• |
Discussions with the FDA are ongoing regarding the SPA and the development pathway of APX3330 for the treatment of DR.
|
• |
Enrollment has been strong for the LYNX-2 Phase 3 registration study evaluating phentolamine ophthalmic solution 0.75% for the treatment of decreased visual acuity under low (mesopic) light
conditions following keratorefractive surgery. The LYNX-2 trial is being conducted under conditions of an SPA with the FDA.
|
• |
The Company is also planning an additional Phase 3 study for decreased vision under mesopic (low) light conditions following keratorefractive surgery, LYNX-3, in 2024.
|
• |
The phentolamine ophthalmic solution 0.75% development portfolio is being funded by Ocuphire’s partner in both indications (presbyopia and dim light vision disturbances).
|
• |
The success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts;
|
• |
Regulatory requirements or developments;
|
• |
Changes to or unanticipated events in connection with clinical trial designs and regulatory pathways;
|
• |
Delays or difficulties in the enrollment of patients in clinical trials;
|
• |
Substantial competition and rapid technological change;
|
• |
Our development of sales and marketing infrastructure;
|
• |
Future revenue losses and profitability;
|
• |
• |
Changes in capital resource requirements;
|
• |
Risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs;
|
• |
• |
Employee misconduct;
|
• |
Changes in market opportunities and acceptance;
|
• |
• |
Future, potential product liability and securities litigation;
|
• |
System failures, unplanned events, or cyber incidents;
|
• |
The substantial number of shares subject to potential issuance associated with our equity line of credit arrangement;
|
• |
Risks that our partnership with our commercial partner, or our other licensing arrangements, may not facilitate the commercialization or market acceptance of Ocuphire’s product
candidates;
|
• |
Future fluctuations in the market price of our common stock;
|
• |
The success and timing of commercialization of any of Ocuphire’s product candidates; and
|
• |
Obtaining and maintaining Ocuphire’s intellectual property rights.
|
Corporate
|
Investor Relations
|
Nirav Jhaveri, MBA
CFO
ir@ocuphire.com
|
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
|
As of
|
||||||||
June 30,
|
December 31,
|
|||||||
2024
|
2023
|
|||||||
Assets
|
(unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
41,409
|
$
|
50,501
|
||||
Accounts receivable
|
1,358
|
926
|
||||||
Contract assets and unbilled receivables
|
948
|
1,407
|
||||||
Prepaids and other assets
|
1,114
|
1,099
|
||||||
Short-term investments
|
5
|
15
|
||||||
Total current assets
|
44,834
|
53,948
|
||||||
Property and equipment, net
|
—
|
—
|
||||||
Total assets
|
$
|
44,834
|
$
|
53,948
|
||||
Liabilities and stockholders’ equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
634
|
$
|
2,153
|
||||
Accrued expenses
|
3,490
|
1,815
|
||||||
Derivative liability
|
74
|
74
|
||||||
Total current liabilities
|
4,198
|
4,042
|
||||||
Total liabilities
|
4,198
|
4,042
|
||||||
Commitments and contingencies
|
||||||||
Stockholders’ equity:
|
||||||||
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of June 30, 2024 and December 31, 2023; no shares
issued and outstanding at June 30, 2024 and December 31, 2023.
|
—
|
—
|
||||||
Common stock, par value $0.0001; 125,000,000 and 75,000,000 shares authorized as of June 30, 2024 and December 31, 2023,
respectively; 25,979,038 and 23,977,491 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively.
|
3
|
2
|
||||||
Additional paid-in capital
|
136,970
|
131,370
|
||||||
Accumulated deficit
|
(96,337
|
)
|
(81,466
|
)
|
||||
Total stockholders’ equity
|
40,636
|
49,906
|
||||||
Total liabilities and stockholders’ equity
|
$
|
44,834
|
$
|
53,948
|
For the Three Months Ended
June 30,
|
For the Six Months Ended
June 30,
|
|||||||||||||||
2024
|
2023
|
2024
|
2023
|
|||||||||||||
License and collaborations revenue
|
$
|
1,112
|
$
|
3,674
|
$
|
2,823
|
$
|
5,423
|
||||||||
Operating expenses:
|
||||||||||||||||
General and administrative
|
3,354
|
4,340
|
8,024
|
6,625
|
||||||||||||
Research and development
|
6,086
|
4,723
|
10,835
|
10,318
|
||||||||||||
Total operating expenses
|
9,440
|
9,063
|
18,859
|
16,943
|
||||||||||||
Loss from operations
|
(8,328
|
)
|
(5,389
|
)
|
(16,036
|
)
|
(11,520
|
)
|
||||||||
Other income, net
|
563
|
428
|
1,165
|
768
|
||||||||||||
Loss before income taxes
|
(7,765
|
)
|
(4,961
|
)
|
(14,871
|
)
|
(10,752
|
)
|
||||||||
Benefit (provision) for income taxes
|
—
|
—
|
—
|
—
|
||||||||||||
Net loss
|
(7,765
|
)
|
(4,961
|
)
|
(14,871
|
)
|
(10,752
|
)
|
||||||||
Other comprehensive loss, net of tax
|
—
|
—
|
—
|
—
|
||||||||||||
Comprehensive loss
|
$
|
(7,765
|
)
|
$
|
(4,961
|
)
|
$
|
(14,871
|
)
|
$
|
(10,752
|
)
|
||||
Net loss per share:
|
||||||||||||||||
Basic and diluted
|
$
|
(0.30
|
)
|
$
|
(0.24
|
)
|
$
|
(0.59
|
)
|
$
|
(0.51
|
)
|
||||
Number of shares used in per share calculations:
|
||||||||||||||||
Basic and diluted
|
25,827,265
|
20,959,807
|
25,175,596
|
20,949,763
|
Document and Entity Information |
Aug. 13, 2024 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Aug. 13, 2024 |
Entity File Number | 001-34079 |
Entity Registrant Name | Ocuphire Pharma, Inc. |
Entity Central Index Key | 0001228627 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 11-3516358 |
Entity Address, Address Line One | 37000 Grand River Avenue, Suite 120 |
Entity Address, City or Town | Farmington Hills |
Entity Address, State or Province | MI |
Entity Address, Postal Zip Code | 48335 |
City Area Code | 248 |
Local Phone Number | 957-9024 |
Title of 12(b) Security | Common Stock, $0.0001 par value per share |
Trading Symbol | OCUP |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
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