• |
APX3330: End of Phase
2 meeting with FDA to confirm Phase 3 regulatory path for Oral APX3330 in DR (2H 2023)
|
• |
Nyxol: PDUFA date for Nyxol in RM. FDA approval in RM would trigger a $10 million milestone payment to Ocuphire (September 28, 2023)
|
• |
Nyxol: Topline
results from VEGA-2 Phase 3 pivotal trial of Nyxol in Presbyopia (Late 2023)
|
• |
In January 2023, the Company announced topline results from the ZETA-1 Phase 2 trial of oral APX3330 for the treatment of diabetic retinopathy (DR). Oral APX3330 achieved statistical
significance on a key pre-specified secondary endpoint of binocular ≥ 3-step worsening of DRSS and demonstrated favorable safety and tolerability. This binocular secondary endpoint is a potential Phase 3 registration endpoint. The Company
plans an End-of-Phase 2 FDA meeting in the second half of 2023 to formally confirm this endpoint and other clinical trial parameters.
|
• |
In February 2023, the Company announced that the FDA has accepted for review a New Drug
Application (NDA) for Nyxol® in RM and set a PDUFA date of September 28, 2023. FDA approval in RM would trigger a $10
million milestone payment to Ocuphire.
|
• |
Topline results from the VEGA-2 Phase 3 pivotal trial of Nyxol in presbyopia are expected in late 2023. Nyxol clinical programs in presbyopia and dim light disturbances (DLD) continue to
progress as planned.
|
• |
From January 2023 through May 2023, several papers, posters, and panel talks were presented at medical and industry conferences with updates on APX3330 in DR and Nyxol in RM, DLD and
presbyopia. Highlights include:
|
• |
Results from ZETA-1 Phase 2 trial of APX3330 in DR were presented for the first time to the medical community at the 20th Angiogenesis, Exudation, and Degeneration
2023 Meeting in February 2023.
|
• |
Results from LYNX-1 Phase 3 trial of Nyxol in DLD were presented for the first time to the medical community at the Association for Research in Vision and Ophthalmology (ARVO) Annual
Meeting in April 2023, and at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in May 2023.
|
• |
Previously announced results from ZETA-1 Phase 2 trial of APX3330 in DR were presented to the medical community at the American Society of Cataract and Refractive
Surgery (ASCRS) Annual Meeting in May 2023.
|
Corporate
|
Investor Relations
|
|
Rick Rodgers
Interim President & CEO
|
Corey Davis, Ph.D.
LifeSci Advisors
|
Bret Shapiro
CoreIR
|
As of
|
||||||||
March 31,
2023
(unaudited)
|
December
31,
2022
|
|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
38,988
|
$
|
42,634
|
||||
Accounts receivable
|
2,834
|
1,298
|
||||||
Contract asset
|
2,467
|
3,552
|
||||||
Prepaids and other current assets
|
1,088
|
1,453
|
||||||
Short-term investments
|
22
|
49
|
||||||
Total current assets
|
45,399
|
48,986
|
||||||
Property and equipment, net
|
5
|
6
|
||||||
Total assets
|
$
|
45,404
|
$
|
48,992
|
||||
Liabilities and stockholders’ equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
2,221
|
$
|
1,069
|
||||
Accrued expenses
|
1,933
|
1,684
|
||||||
Total current liabilities
|
4,154
|
2,753
|
||||||
Warrant liabilities
|
—
|
—
|
||||||
Total liabilities
|
4,154
|
2,753
|
||||||
Commitments and contingencies
|
||||||||
Stockholders’ equity
|
||||||||
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of March 31, 2023 and December 31, 2022; no shares
issued and outstanding at March 31, 2023 and December 31, 2022.
|
—
|
—
|
||||||
Common stock, par value $0.0001; 75,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 20,947,830
and 20,861,315 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively.
|
2
|
2
|
||||||
Additional paid-in capital
|
118,519
|
117,717
|
||||||
Accumulated deficit
|
(77,271
|
)
|
(71,480
|
)
|
||||
Total stockholders’ equity
|
41,250
|
46,239
|
||||||
Total liabilities and stockholders’ equity
|
$
|
45,404
|
$
|
48,992
|
Three Months Ended
|
||||||||
March 31,
|
||||||||
2023
|
2022
|
|||||||
License and collaborations revenue
|
$
|
1,749
|
$
|
—
|
||||
Operating expenses:
|
||||||||
General and administrative
|
2,285
|
1,736
|
||||||
Research and development
|
5,595
|
4,772
|
||||||
Total operating expenses
|
7,880
|
6,508
|
||||||
Loss from operations
|
(6,131
|
)
|
(6,508
|
)
|
||||
Interest expense
|
—
|
(5
|
)
|
|||||
Fair value change in warrant liabilities
|
—
|
—
|
||||||
Other income (expense), net
|
340
|
(82
|
)
|
|||||
Loss before income taxes
|
(5,791
|
)
|
(6,595
|
)
|
||||
Benefit (provision) for income taxes
|
—
|
—
|
||||||
Net loss
|
(5,791
|
)
|
(6,595
|
)
|
||||
Other comprehensive loss, net of tax
|
—
|
—
|
||||||
Comprehensive loss
|
$
|
(5,791
|
)
|
$
|
(6,595
|
)
|
||
Net loss per share:
|
||||||||
Basic and diluted
|
$
|
(0.28
|
)
|
$
|
(0.35
|
)
|
||
Number of shares used in per share calculations:
|
||||||||
Basic and diluted
|
20,939,607
|
18,888,471
|