● |
Reversal of Mydriasis (RM): Plan to submit New Drug Application (NDA) with the FDA for
Nyxol in RM indication in Q4 2022, with potential approval and commercial launch as first dilation reversal drop in 2023.
|
● |
Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Plan to report top-line results
from the ZETA-1 Phase 2b trial of APX3330 in early 2023. APX3330 is a novel oral therapy with a dual mechanism of action in validated pathways, decreasing both abnormal angiogenesis and inflammation.
|
● |
Presbyopia: Plan to initiate VEGA-2 Phase 3 trial in Q4 2022 investigating Nyxol alone and
Nyxol with 0.4% low-dose pilocarpine (LDP) as adjunctive therapy. In addition, VEGA-3 (2nd Phase 3) and LYRA-1 (1-year safety) trials are planned to begin in 2023.
|
● |
In September, the Company announced that the last of the 103 enrolled patients in the ZETA-1 Phase 2b trial of oral APX3330 for the treatment of diabetic retinopathy (DR) completed
the final visit of the 24-week study.
|
● |
In September, the Company announced that U.S. Food and Drug Administration (FDA) has granted a small-business waiver of the Prescription Drug User Fee Act (PDUFA) fee of $3.1
million for the 505(b)(2) NDA for Nyxol.
|
● |
Year to date, Ocuphire was represented at multiple key ophthalmological conferences with updates on Nyxol in RM, presbyopia and night vision disturbances, as well as masked safety
data for APX3330 in DR. In total, more than 25 papers, posters, and panel talks were presented over 20 medical and industry conferences. Highlights in October and early November 2022:
|
● |
Mitchell Jackson, MD presented a poster highlighting presbyopia data at the American Academy of Ophthalmology Annual Meeting in Chicago, IL.
|
● |
Prominent optometry thought leaders and clinical trial investigators Justin Schweitzer, OD, Mitch Ibach, OD, Leslie O’Dell, OD, Shane Foster, OD, Doug , Devries, OD and Shane
Kannarr, OD presented six posters on Nyxol and APX3330 at the American Academy of Optometry Annual Meeting in San Diego, CA.
|
● |
The Company announced publication of an earlier Phase 2 clinical trial in patients with severe night vision disturbances in the BMC Ophthalmology peer-reviewed journal. The
publication can be accessed here.
|
● |
In October, the Company held a Key Opinion Leader (KOL) webinar on oral APX3330. The event featured presentations by KOLs Peter Kaiser, MD, from the Cleveland Clinic, Caroline
Baumal, MD, from Tufts Medical Center, and David Lally, MD, from New England Retina Consultants. KOL. The discussion highlighted the unmet need and current treatment landscape for DR/DME and included new data on study demographics and 24-week
masked safety data from the ZETA-1 trial. A replay of the event can be found on the company’s corporate website here.
|
● |
On August 2, 2022, Ocuphire was granted extended intellectual property protection for Nyxol with the issuance of U.S. Patent No. 11,400,077 with claims directed to methods for
mydriasis treatment using phentolamine, extended by 5 years into 2039.
|
● |
In September, the Company appointed seven new Key Opinion Leaders (KOLs) across retina, cornea/refractive, and medical optometry to its Medical Advisory Board (MAB): Anat
Loewenstein, MD, PhD, Caroline Baumal, MD, Zaina Al-Mohtaseb, MD, Inder Paul Singh, MD, Leslie O’Dell, OD, Selina McGee, OD, Justin Schweitzer, OD.
|
● |
MIRA-2 (NCT04620213), MIRA-3 (NCT05134974), and MIRA-4 (NCT05223478 pediatric safety trial) registration trials for the treatment of RM
|
● |
VEGA-1 (NCT04675151) Phase 2 trial of Nyxol for treatment of presbyopia, which evaluated
both Nyxol as a single agent and Nyxol with low dose pilocarpine (“LDP”) 0.4% as adjunctive therapy
|
● |
LYNX-1 (NCT04638660) Phase 3 trial of Nyxol for night vision disturbances (NVD)
|
Corporate
|
Investor Relations
|
|
Mina Sooch, MBA
CEO & Founder
|
As of
|
||||||||
September 30,
|
December 31,
|
|||||||
2022
|
2021
|
|||||||
(unaudited)
|
||||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
13,855
|
$
|
24,534
|
||||
Prepaids and other current assets
|
605
|
1,314
|
||||||
Short-term investments
|
101
|
219
|
||||||
Total current assets
|
14,561
|
26,067
|
||||||
Property and equipment, net
|
7
|
10
|
||||||
Total assets
|
$
|
14,568
|
$
|
26,077
|
||||
Liabilities and stockholders’ equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
1,468
|
$
|
1,584
|
||||
Accrued expenses
|
1,223
|
1,733
|
||||||
Short-term loan
|
—
|
538
|
||||||
Total current liabilities
|
2,691
|
3,855
|
||||||
Warrant liabilities
|
—
|
—
|
||||||
Total liabilities
|
2,691
|
3,855
|
||||||
Commitments and contingencies
|
||||||||
Stockholders’ equity:
|
||||||||
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of September 30, 2022, and
December 31, 2021; no shares issued and outstanding at September 30, 2022 and December 31, 2021.
|
—
|
—
|
||||||
Common stock, par value $0.0001; 75,000,000 shares authorized as of September 30, 2022 and December
31, 2021; 20,801,506 and 18,845,828 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively.
|
2
|
2
|
||||||
Additional paid-in-capital
|
117,296
|
111,588
|
||||||
Accumulated deficit
|
(105,421
|
)
|
(89,368
|
)
|
||||
Total stockholders’ equity
|
11,877
|
22,222
|
||||||
Total liabilities and stockholders’ equity
|
$
|
14,568
|
$
|
26,077
|
For the Three Months Ended
|
For the Nine Months Ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2022
|
2021
|
2022
|
2021
|
|||||||||||||
Collaborations revenue
|
$
|
—
|
$
|
489
|
$
|
—
|
$
|
589
|
||||||||
Operating expenses:
|
||||||||||||||||
General and administrative
|
1,703
|
1,595
|
5,215
|
6,707
|
||||||||||||
Research and development
|
2,835
|
3,126
|
10,769
|
10,437
|
||||||||||||
Total operating expenses
|
4,538
|
4,721
|
15,984
|
17,144
|
||||||||||||
Loss from operations
|
(4,538
|
)
|
(4,232
|
)
|
(15,984
|
)
|
(16,555
|
)
|
||||||||
Interest expense
|
—
|
—
|
(9
|
)
|
—
|
|||||||||||
Fair value change of warrant liabilities
|
—
|
—
|
—
|
(33,829
|
)
|
|||||||||||
Other income (expense), net
|
7
|
2
|
(60
|
)
|
4
|
|||||||||||
Loss before income taxes
|
(4,531
|
)
|
(4,230
|
)
|
(16,053
|
)
|
(50,380
|
)
|
||||||||
Benefit (provision) for income taxes
|
—
|
—
|
—
|
—
|
||||||||||||
Net loss
|
(4,531
|
)
|
(4,230
|
)
|
(16,053
|
)
|
(50,380
|
)
|
||||||||
Other comprehensive loss, net of tax
|
—
|
—
|
—
|
—
|
||||||||||||
Comprehensive loss
|
$
|
(4,531
|
)
|
$
|
(4,230
|
)
|
$
|
(16,053
|
)
|
$
|
(50,380
|
)
|
||||
Net loss per share:
|
||||||||||||||||
Basic and diluted
|
$
|
(0.22
|
)
|
$
|
(0.25
|
)
|
$
|
(0.82
|
)
|
$
|
(3.64
|
)
|
||||
Number of shares used in per share calculations:
|
||||||||||||||||
Basic and diluted
|
20,498,229
|
16,925,006
|
19,635,651
|
13,841,067
|