• |
APX3330: Special Protocol Assessment (“SPA”)
submission and agreement with U.S. Food and Drug Administration (“FDA”)
|
• |
In October 2023, Ocuphire had a successful End-of-Phase 2 (“EOP2”) meeting with the FDA for oral APX3330 in Diabetic Retinopathy and agreed on the Phase 3 primary
endpoint of 3-step worsening (measuring delay or prevention of progression) on a binocular diabetic retinopathy severity scale. The Company plans to submit a SPA to the FDA to agree on the protocol and statistical analysis plan of the first
Phase 3 trial.
|
• |
In September 2023, Ocuphire and Viatris announced FDA approval of RYZUMVI™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically induced
mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide). Ocuphire received a $10 million milestone payment from Viatris upon the approval. RYZUMVI is expected to be commercially available in the U.S. in the first half of 2024.
|
• |
The VEGA-2 Phase 3 study evaluating phentolamine ophthalmic solution 0.75% in presbyopia achieved its primary endpoint. Viatris is expected to continue Phase 3
development for this indication in the first half of 2024.
|
• |
The Company has submitted a SPA to the FDA for night vision disturbances or dim light vision and Viatris is expected to continue Phase 3 development of phentolamine ophthalmic solution 0.75% for this indication in the first half of 2024.
|
• |
A presentation at the Eyecelerator American Academy of Ophthalmology 2023 Retina Showcase by Jay Pepose, M.D. Ph.D., Chief Medical Advisor, highlighting the agreement
of Phase 3 registration endpoint at the EOP2 FDA meeting.
|
• |
A paper presentation delivered by Veeral Sheth, M.D., at the 23rd Euretina Congress in October 2023.
|
• |
An oral presentation delivered by Anat Lowenstein, M.D., at the 56th Annual Retina Society Scientific Meeting in October 2023.
|
• |
An oral presentation delivered by Priya Vakharia, M.D., at the Women in Ophthalmology Summer Symposium in August 2023. The abstract was rated as one
of the top three scoring abstracts out of nearly 600 submissions and received the Joanne Angle Abstract of Distinction Award.
|
Corporate
|
Investor Relations
|
George Magrath, M.D., M.B.A., M.S.
CEO
|
Corey Davis, Ph.D.
LifeSci Advisors
|
As of
|
||||||||
September 30,
2023
(unaudited)
|
December 31,
2022
|
|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
42,350
|
$
|
42,634
|
||||
Accounts receivable
|
10,132
|
1,298
|
||||||
Contract assets and unbilled receivables
|
1,211
|
3,552
|
||||||
Prepaids and other current assets
|
484
|
1,453
|
||||||
Short-term investments
|
11
|
49
|
||||||
Total current assets
|
54,188
|
48,986
|
||||||
Property and equipment, net
|
3
|
6
|
||||||
Total assets
|
$
|
54,191
|
$
|
48,992
|
||||
Liabilities and stockholders’ equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
1,890
|
$
|
1,069
|
||||
Accrued expenses
|
1,926
|
1,684
|
||||||
Derivative liability
|
93
|
—
|
||||||
Total current liabilities
|
3,909
|
2,753
|
||||||
Total liabilities
|
3,909
|
2,753
|
||||||
Commitments and contingencies
|
||||||||
Stockholders’ equity
|
||||||||
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of September 30, 2023 and
December 31, 2022; no shares issued and outstanding at September 30, 2023 and December 31, 2022.
|
—
|
—
|
||||||
Common stock, par value $0.0001; 75,000,000 shares authorized as of September 30, 2023 and
December 31, 2022; 22,610,131 and 20,861,315 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively.
|
2
|
2
|
||||||
Additional paid-in capital
|
126,951
|
117,717
|
||||||
Accumulated deficit
|
(76,671
|
)
|
(71,480
|
)
|
||||
Total stockholders’ equity
|
50,282
|
46,239
|
||||||
Total liabilities and stockholders’ equity
|
$
|
54,191
|
$
|
48,992
|
For the Three Months Ended
September 30,
|
For the Nine Months Ended
September 30,
|
|||||||||||||||
2023
|
2022
|
2023
|
2022
|
|||||||||||||
License and collaborations revenue
|
$
|
11,935
|
$
|
—
|
$
|
17,358
|
$
|
—
|
||||||||
Operating expenses:
|
||||||||||||||||
General and administrative
|
2,055
|
1,703
|
8,680
|
5,215
|
||||||||||||
Research and development
|
3,494
|
2,835
|
13,812
|
10,769
|
||||||||||||
Total operating expenses
|
5,549
|
4,538
|
22,492
|
15,984
|
||||||||||||
Income (loss) from operations
|
6,386
|
(4,538
|
)
|
(5,134
|
)
|
(15,984
|
)
|
|||||||||
Financing costs
|
(1,328
|
)
|
—
|
(1,328
|
)
|
—
|
||||||||||
Interest expense
|
—
|
—
|
—
|
(9
|
)
|
|||||||||||
Fair value change in derivative liability
|
61
|
—
|
61
|
—
|
||||||||||||
Other income (expense), net
|
456
|
7
|
1,224
|
(60
|
)
|
|||||||||||
Income (loss) before income taxes
|
5,575
|
(4,531
|
)
|
(5,177
|
)
|
(16,053
|
)
|
|||||||||
Provision for income taxes
|
(14
|
)
|
—
|
(14
|
)
|
—
|
||||||||||
Net income (loss)
|
5,561
|
(4,531
|
)
|
(5,191
|
)
|
(16,053
|
)
|
|||||||||
Other comprehensive income (loss), net of tax
|
—
|
—
|
—
|
—
|
||||||||||||
Comprehensive income (loss)
|
$
|
5,561
|
$
|
(4,531
|
)
|
$
|
(5,191
|
)
|
$
|
(16,053
|
)
|
|||||
Net income (loss) per share:
|
||||||||||||||||
Basic
|
$
|
0.26
|
$
|
(0.22
|
)
|
$
|
(0.25
|
)
|
$
|
(0.82
|
)
|
|||||
Diluted
|
$
|
0.25
|
$
|
(0.22
|
)
|
$
|
(0.25
|
)
|
$
|
(0.82
|
)
|
|||||
Number of shares used in per share calculations:
|
||||||||||||||||
Basic
|
21,446,648
|
20,498,229
|
21,117,211
|
19,635,651
|
||||||||||||
Diluted
|
22,405,995
|
20,498,229
|
21,117,211
|
19,635,651
|