Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic
biopharmaceutical company focused on developing and commercializing
therapies for the treatment of several eye disorders, today
announced financial results for the first quarter of 2021 and
provided a corporate update.
“The highlight of the first quarter was our
announcement of positive top-line results from the pivotal MIRA-2
Phase 3 trial investigating Nyxol® eye drops for reversal of
pharmacologically-induced mydriasis (pupil dilation). The highly
statistically significant results provide the foundation to advance
Nyxol towards NDA submission in an indication representing over 100
million annual eye exams with no commercial treatments currently
available”, said Mina Sooch, MBA, President and CEO of Ocuphire
Pharma. “The recent Phase 3 data further validate Nyxol’s unique
mechanism of action on the iris dilator muscle, its consistent
therapeutic effect of pupil diameter reduction, and its favorable
safety and tolerability profile for additional refractive
indications including Presbyopia and Night Vision Disturbances. We
are also making progress with our second product candidate,
APX3330, and are currently enrolling patients in a Phase 2 trial
primarily in Diabetic Retinopathy. Overall, 2021 is off to a strong
start and we look forward to more updates on our programs
throughout the year including the Phase 2 Presbyopia data readout
expected at the end of June.”
Cam Gallagher, MBA, Chair of Ocuphire’s Board of
Directors commented, “Since our public listing via reverse merger
just six months ago, the management team together with Ocuphire’s
clinical and manufacturing partners have successfully launched an
impressive four Phase 3 and 2 clinical trials for Nyxol and
APX3330, clearly demonstrating their execution capabilities.
Importantly, data from multiple trials at Ocuphire have been
published in several peer-reviewed journals and presented at
multiple ophthalmic and healthcare banking conferences, further
establishing our presence within the industry. We look forward to
continuing this momentum in 2021, and with our recent positive
Phase 3 data, we are excited to move ahead with our
commercialization strategies for Nyxol.”
Key Anticipated Future
Milestones
-
Presbyopia: Top-line data expected end of Q2 2021
for Phase 2 VEGA-1 trial investigating a kit combination of Nyxol
and low-dose 0.4% pilocarpine
- Reversal
of Mydriasis: Presenting Phase 3 MIRA-2 results at the
2021 American Society of Cataract and Refractive Surgeons
conference in Las Vegas in July
- Night
Vision Disturbances: Top-line data expected end of Q3 2021
for pivotal Phase 3 LYNX-1 trial investigating Nyxol
- Reversal
of Mydriasis: Planning to initiate second Phase 3 MIRA-3
registration trial in 2H 2021 investigating Nyxol with results
expected in early 2022
- Diabetic
Retinopathy and Diabetic Macular Edema: Completion of
enrollment in Phase 2 ZETA-1 trial investigating APX3330 with
top-line data expected early 2022
First Quarter and Recent Business
Highlights
Clinical Development
- Reported positive
results in pivotal Phase 3 MIRA-2 trial investigating Nyxol for
Reversal of Mydriasis (within 4 months of initiation) which met
primary and multiple secondary endpoints demonstrating a more rapid
return to baseline pupil diameter after dilation across multiple
commonly used dilating agents and iris colors
- Initiated ZETA-1
Phase 2 trial investigating the first-in-class oral anti-VEGF and
anti-inflammatory APX3330 in Diabetic Retinopathy and Diabetic
Macular Edema
- Initiated Phase 2
VEGA-1 trial evaluating a kit combination of Nyxol and low-dose
pilocarpine in Presbyopia with a differentiated pharmacologic
approach that moderately acts on both the iris dilator and iris
sphincter muscles that control pupil diameter
Presentations and Publications
- Presented
positive pre-clinical data supporting oral APX3330’s efficacy and
sufficient exposure to the retina at the Association for Research
in Vision and Ophthalmology (ARVO) virtual Annual Meeting
- Published
positive results from the MIRA-1 Phase 2b clinical trial
evaluating the safety and efficacy of Nyxol for Reversal of
Mydriasis in Optometry and Visual Science journal
- Presented
highlights of Nyxol presbyopia program at the 2021 Ophthalmology
Innovation Summit (OIS) Presbyopia Innovation Showcase
First Quarter 2021 Financial
Highlights
As of March 31, 2021, the Company had cash and cash
equivalents of approximately $10.6 million.
General and administrative expenses for the three
months ended March 31, 2021 were $1.7 million compared to $0.4
million for the three months ended March 31, 2020. The $1.3 million
increase was primarily attributable to an increase in
administrative employee headcount, stock-based compensation,
professional services, insurance, and legal costs associated with
the operating as a public company in the current period subsequent
to the merger.
Research and development expenses for the three
months ended March 31, 2021 were $3.5 million compared to $0.2
million for the three months ended March 31, 2020. The $3.3 million
increase as compared to the prior period was primarily attributable
to four new clinical trials and manufacturing activities for Nyxol
and APX3330 as well as regulatory, preclinical, and other
development activities.
The total GAAP loss from operations for the three
months ended March 31, 2021 was $5.2 million compared to $2.7
million for the three months ended March 31, 2020. This included
non-cash stock-based compensation expense of $494,000 and $61,000,
respectively.
The quarter ended March 31, 2021 included a
non-cash charge of $33.8 million related to the fair value change
in warrant liabilities included in other expense. The quarter ended
March 31, 2020 included a non-cash charge of $0.6 million related
to interest expense on convertible notes and a $0.2 million
non-cash benefit due to the fair value change in premium conversion
derivatives related to convertible notes, both included in other
expense. As a result, GAAP net loss attributable to common
stockholders for the quarter ended March 31, 2021 was $39.0 million
compared to $3.1 million for the quarter ended March 31, 2020.
Effective February 3, 2021, each investor that
invested in the Pre-Merger Financing entered into a Waiver
Agreement with Ocuphire. The Waiver Agreements provide for the
elimination of the full ratchet anti-dilution provisions contained
in the Series A Warrants (as certain of the anti-dilution
provisions had previously caused liability accounting treatment for
the Series A Warrants). Upon the effective date of the Waiver
Agreements, the Series A Warrants were reclassified to equity. In
addition, the investors agreed to waive certain rights, finalize
the exercise price and number of Series A Warrants and Series B
Warrants, eliminate certain financing restrictions, extend the term
of certain leak-out agreements, and, in the case of certain
investors, grant certain registration rights for the shares
underlying the Series A Warrants.
Non-GAAP adjusted net loss was $5.2 million or
($0.47) per share for the three months ended March 31, 2021,
compared with a non-GAAP adjusted net loss of $3.3 million or
($0.93) per share for the three months ended March 31, 2020.
Non-GAAP adjusted net loss for the three months ended March 31,
2021 and 2020 excludes expenses for the fair value change in
warrant liabilities related to the Pre-Merger Financing and premium
conversion derivatives related to convertible notes, respectively.
See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to
Non-GAAP Financial Measures" below for a reconciliation of this
GAAP and non-GAAP financial measure.
For further details on Ocuphire’s financial
results, refer to the Company’s Quarterly Report on Form 10-Q for
the quarter ended March 31, 2021, to be filed with the Securities
and Exchange Commission.
About Ocuphire Pharma
Ocuphire is a publicly traded (NASDAQ: OCUP),
clinical-stage ophthalmic biopharmaceutical company focused on
developing and commercializing therapies for the treatment of
several eye disorders. Ocuphire’s pipeline currently includes two
small-molecule product candidates – Nyxol and APX3330 – targeting
front and back of the eye indications. As part of its strategy,
Ocuphire will continue to explore opportunities to acquire
additional ophthalmic assets and to seek strategic partners for
late-stage development, regulatory preparation, and
commercialization in key global markets. For more information,
please visit www.ocuphire.com.
About Nyxol
Ocuphire’s lead product candidate,
Nyxol® (0.75% phentolamine ophthalmic solution) Eye Drops, is
a once-daily, preservative-free eye drop formulation of
phentolamine mesylate, a non-selective alpha-1 and alpha-2
adrenergic antagonist designed to reduce pupil size, and is being
developed for several indications, including dim light or night
vision disturbances (NVD), reversal of pharmacologically-induced
mydriasis (RM), and presbyopia. Nyxol has been studied in 8
clinical trials demonstrating a favorable safety and tolerability
profile. Ocuphire recently reported positive top-line data for
pivotal MIRA-2 Phase 3 trial for treatment of RM. Nyxol is also
currently in Phase 2 for presbyopia, with top-line results expected
Q2 2021, and in Phase 3 clinical development for NVD with top-line
results expected Q3 2021. Please
visit www.clinicaltrials.gov to learn more about
Ocuphire’s completed Phase 2 trials in RM, Glaucoma, and NVD,
recently completed Phase 3 registration trial in
RM (NCT04620213), and ongoing Phase 2 trial in presbyopia
(NCT04675151) and Phase 3 registration trial in
NVD (NCT04638660).
About APX3330
Ocuphire’s second product candidate, APX3330, is a
small molecule oral drug candidate and a first-in-class inhibitor
of the transcription factor regulator Ref-1 (reduction-oxidation
effector factor-1). With its novel mechanism of action, APX3330
blocks the downstream pathways regulated by Ref-1, specifically
decreasing abnormal activation of both angiogenesis (VEGF) and
inflammatory (NF-kB) pathways that are relevant to retinal and
choroidal vascular diseases, including diabetic retinopathy (DR),
diabetic macular edema (DME), and age-related macular degeneration
(AMD). APX3330 has been studied in 11 Phase 1 and 2 trials and has
demonstrated a favorable safety and tolerability profile in over
300 oncology and hepatic patients. APX3330 is actively recruiting
in a Phase 2 trial in DR/DME, with results expected in early 2022.
Please visit www.clinicaltrials.gov for more information about
Ocuphire’s ongoing Phase 2 trial in DR/DME (NCT04692688).
Forward Looking Statements
Statements contained in this press release
regarding matters that are not historical facts are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to, statements concerning Ocuphire’s product
candidates, results of ongoing and future clinical trials, and
commercialization and market opportunities. These forward-looking
statements are based upon Ocuphire’s current expectations and
involve assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties,
including, without limitation: (i) the success and timing of
regulatory submissions and pre-clinical and clinical trials,
including enrollment and data readouts; (ii) regulatory
requirements or developments; (iii) changes to clinical trial
designs and regulatory pathways; (iv) changes in capital resource
requirements; (v) risks related to the inability of Ocuphire to
obtain sufficient additional capital to continue to advance its
product candidates and its preclinical programs; (vi) legislative,
regulatory, political and economic developments, (vii) changes
in market opportunities, (viii) the effects of COVID-19 on
clinical programs and business operations, and (ix) the success and
timing of commercialization of any of Ocuphire’s product
candidates. The foregoing review of important factors that could
cause actual events to differ from expectations should not be
construed as exhaustive and should be read in conjunction with
statements that are included herein and elsewhere, including the
risk factors detailed in documents that have been and may be filed
by Ocuphire from time to time with the SEC. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Ocuphire undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were
made.
Note: All educational content of the ASCRS ASOA
Annual Meeting is planned by its program committee, and ASCRS ASOA
does not endorse, promote, approve, or recommend the use of any
products, devices, or services.
Ocuphire Contacts
Mina Sooch, President & CEO Ocuphire
Pharma, Inc. ir@ocuphire.com www.ocuphire.com
Corey Davis, Ph.D.LifeSci
Advisorscdavis@lifescieadvisors.com
|
Ocuphire Pharma,
Inc.Condensed Consolidated
Balance Sheets(in thousands,
except share amounts and par value) |
|
|
|
As of |
|
March 31, |
|
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
10,597 |
|
|
$ |
16,399 |
|
Prepaids and other assets |
|
1,428 |
|
|
|
1,269 |
|
Deferred costs |
|
88 |
|
|
|
— |
|
Total current assets |
|
12,113 |
|
|
|
17,668 |
|
Property and equipment, net |
|
13 |
|
|
|
14 |
|
Total assets |
$ |
12,126 |
|
|
$ |
17,682 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ deficit |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,415 |
|
|
$ |
1,214 |
|
Accrued expenses |
|
895 |
|
|
|
1,971 |
|
Total current liabilities |
|
2,310 |
|
|
|
3,185 |
|
Warrant liabilities |
|
— |
|
|
|
27,964 |
|
Total liabilities |
|
2,310 |
|
|
|
31,149 |
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity (deficit) |
|
|
|
|
|
|
|
Preferred stock, par value $0.0001; 10,000,000 shares authorized as
of March 31, 2021 and December 31, 2020; no shares issued and
outstanding at March 31, 2021 and December 31, 2020. |
|
— |
|
|
|
— |
|
Common stock, par value $0.0001; 75,000,000 shares authorized as of
March 31, 2021 and December 31, 2020; 10,929,881 and 10,882,495
shares issued and outstanding at March 31, 2021 and December 31,
2020, respectively. |
|
1 |
|
|
|
1 |
|
Additional paid-in-capital |
|
81,504 |
|
|
|
19,207 |
|
Accumulated deficit |
|
(71,689 |
) |
|
|
(32,675 |
) |
Total stockholders’ equity (deficit) |
|
9,816 |
|
|
|
(13,467 |
) |
Total liabilities and stockholders’ equity (deficit) |
$ |
12,126 |
|
|
$ |
17,682 |
|
|
Ocuphire Pharma, Inc.Condensed
Consolidated Statements of Comprehensive Loss(in
thousands, except share and per share
amounts)(unaudited) |
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, |
|
2021 |
|
2020 |
Operating expenses: |
|
|
|
|
|
General and administrative |
$ |
1,704 |
|
|
$ |
391 |
|
Research and development |
|
3,482 |
|
|
|
218 |
|
Acquired in process research and development |
|
— |
|
|
|
2,126 |
|
Total operating expenses |
|
5,186 |
|
|
|
2,735 |
|
Loss from operations |
|
(5,186 |
) |
|
|
(2,735 |
) |
Interest expense |
|
— |
|
|
|
(554 |
) |
Fair value change in warrant liabilities and premium conversion
derivatives |
|
(33,829 |
) |
|
|
198 |
|
Other income |
|
1 |
|
|
|
3 |
|
Loss before income taxes |
|
(39,014 |
) |
|
|
(3,088 |
) |
Benefit (provision) for income taxes |
|
— |
|
|
|
— |
|
Net loss |
|
(39,014 |
) |
|
|
(3,088 |
) |
Other comprehensive loss, net of tax |
|
— |
|
|
|
— |
|
Comprehensive loss |
$ |
(39,014 |
) |
|
$ |
(3,088 |
) |
Net loss per share: |
|
|
|
|
|
Basic and diluted |
$ |
(3.57 |
) |
|
$ |
(0.87 |
) |
Number of shares used in per share calculations: |
|
|
|
|
|
Basic and diluted |
|
10,923,651 |
|
|
|
3,547,990 |
|
|
|
|
|
|
|
Non-GAAP Financial MeasuresIn
addition to operating results as calculated in accordance with
Generally Accepted Accounting Principles (GAAP), Ocuphire uses
certain non-GAAP financial measures when evaluating operational
performance. The following table presents the Company's net loss
and net loss per common share calculated in accordance with GAAP
and as adjusted to remove the impact of certain non-cash charges.
Ocuphire's management believes that these non-GAAP financial
measures are useful to enhance understanding of the Company's
financial performance and are more indicative of its operational
performance and facilitate a better comparison among fiscal
periods.
These non-GAAP financial measures are not, and
should not be viewed as, substitutes for GAAP reporting measures.
These non-GAAP financial measures are not based on any
comprehensive set of accounting rules or principles, differ from
GAAP measures with the same names, and may differ from non-GAAP
financial measures with the same or similar names that are used by
other companies. Ocuphire believes that non-GAAP financial measures
should only be used to evaluate its results of operations in
conjunction with the corresponding GAAP financial measures.
Ocuphire encourages investors to carefully consider its results
under GAAP, as well as the reconciliations between these
presentations, to more fully understand our business.
Non-GAAP adjusted net loss and non-GAAP adjusted
net loss per share exclude the fair value change in warrant
liabilities and premium conversion derivatives. Ocuphire excludes
these items because they are non-cash expenses and have no direct
correlation to the operation of its business.
Ocuphire Pharma,
Inc.Reconciliation of GAAP to Non-GAAP Financial
Measures(in thousands, except share and per share
amounts)(unaudited)
A reconciliation between GAAP Net Loss to Non-GAAP
adjusted Net Loss and GAAP Net Loss per common share to Non-GAAP
adjusted Net Loss per common share:
|
Three Months Ended |
|
March 31, |
|
2021 |
|
|
2020 |
GAAP Net Loss |
$ |
(39,014 |
) |
|
$ |
(3,088 |
) |
Adjustments: |
|
|
|
|
|
|
|
Fair value change in warrant liabilities and premium conversion
derivatives(1) |
|
33,829 |
|
|
|
(198 |
) |
|
|
|
|
|
|
|
|
Non-GAAP adjusted Net Loss |
$ |
(5,185 |
) |
|
$ |
(3,286 |
) |
GAAP Net Loss per common share, Basic and diluted |
$ |
(3.57 |
) |
|
$ |
(0.87 |
) |
|
|
|
|
|
|
|
|
Adjustment to Net Loss per common share |
|
3.10 |
|
|
|
(0.06 |
) |
Non-GAAP adjusted Net Loss per common share, Basic and diluted |
$ |
(0.47 |
) |
|
$ |
(0.93 |
) |
Number of shares used in per share calculations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
10,923,651 |
|
|
|
3,547,990 |
|
|
|
|
|
|
|
|
|
- To reflect a non-cash charge to
other expense for the fair value change in warrant liabilities and
premium conversion derivatives. The $33.8 million fair value change
in warrant liabilities was due primarily to the issuance of the
Series A warrants in connection with the Pre-Merger Financing and
to the fluctuations in Ocuphire’s common stock fair value (between
December 31, 2020 and February 3, 2021) and other factors.
SOURCE: Ocuphire Pharma, Inc.
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