Full Press Release Details
Ocular Therapeutix Reports
First Quarter 2025 Results and Business Highlights
AXPAXLI SOL trials for wet AMD progressing
rapidly following recent updates to accelerate and enhance the registrational program
Following positive FDA feedback for potential
AXPAXLI NPDR registrational trial, Ocular is actively planning next steps in NPDR and DME
SOL-1 retention remains exceptional as trial
is on track for 1Q 2026 topline data readout
SOL-R continues to have strong enrollment through
streamlined, accelerated execution
Cash balance of $349.7M as of March 31, 2025,
with expected runway through topline data for SOL-1 and SOL-R and into 2028
BEDFORD, MA, May 5, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc.
(NASDAQ: OCUL, "Ocular"), a fully-integrated biopharmaceutical company committed to redefining the retina experience, today
reported financial results for the first quarter ended March 31, 2025, and provided recent business highlights.
"We continue to advance the SOL registrational program for our
product candidate AXPAXLI in wet AMD with urgency and precision. Our unwavering focus is on redefining the retina experience. Delivering
a more sustainable therapy designed to drive better long-term outcomes is central to this effort. Earlier this year, we implemented strategic
regulatory updates designed to accelerate the SOL program, enhancing capital and operational efficiencies. We believe these refinements
could position AXPAXLI for an unprecedented 6 to 12-month dosing regimen on the label for the treatment of wet AMD and potentially enable
an earlier NDA submission. These enhancements were made in alignment with FDA feedback and preserve the scientific integrity and robust
powering of our two complementary registrational studies, SOL-1 and SOL-R," said Pravin U. Dugel, MD, Executive Chairman,
President and Chief Executive Officer of Ocular Therapeutix. "In addition to our momentum in wet AMD, we are thrilled with
the positive written feedback received from the FDA on the design of a potential registrational trial for AXPAXLI in NPDR. These encouraging
interactions represent a meaningful step forward as we plan our next steps in both NPDR and DME."
"Backed by a world-class team, strong capital position, and disciplined
execution, we believe we are in an outstanding position as we pursue our goal of becoming a leading retina company," concluded Dr.
Recent Achievements and Upcoming Milestones:
| SOL-R (Phase 3, wet AMD) enrollment continues to be strong following the recent reduction in target randomization to approximately 555 subjects (previously 825). The strong SOL-1 subject retention observed to date and re-dosing amendment have enabled Ocular to reduce the size of the SOL-R non-inferiority study while continuing to meet the FDA requirements for long-term safety data. Streamlining the execution of SOL-R is expected to accelerate the trial readout and, if successful, the AXPAXLI wet AMD NDA submission timeline. SOL-R remains robustly powered at 90% with the non-inferiority margin of -4.5 ETDRS letter per FDA guidance. | ||
| Written feedback received from FDA on AXPAXLI registrational trial in non-proliferative diabetic retinopathy (NPDR) . The FDA provided positive feedback to Ocular on a potential registrational trial design for AXPAXLI in NPDR. Following recent changes more broadly within the FDA, Ocular has not noticed any disruption in the cadence and nature of its dialogue with the Agency to date and continues to maintain productive interactions. The Company is actively planning next steps in the development of AXPAXLI for NPDR and diabetic macular edema (DME) and expects to provide further details at a later date. |
First Quarter Ended March 31, 2025, Financial Results:
Total cash and cash equivalents were $349.7 million
as of March 31, 2025. Based on current plans and related estimates of anticipated cash inflows from DEXTENZA , the Company believes
that its current cash balance is sufficient to support its planned expenses, debt service obligations, and capital expenditure requirements
into 2028. This cash projection does not factor in the impact of potential clinical trial activities for AXPAXLI in NPDR and DME.
Total net revenue was $10.7 million for
the first quarter of 2025, a 27.6% decrease as compared to total net revenue of $14.8 million in the comparable quarter in 2024. This
decrease was driven by decreased gross revenues from DEXTENZA sales. Total net revenue includes both gross DEXTENZA product revenue, net
of discounts, rebates, and returns, which the Company refers to as net product revenue, and collaboration revenue.
The Company's net product revenue was $10.6 million
for the three months ended March 31, 2025, reflecting a decrease of $4.1 million or 27.7% over the comparable quarter in 2024. The Company
believes the decline in first quarter 2025 DEXTENZA net sales is primarily attributable to the impact of its pricing strategy on distributor
stocking patterns and buying patterns by ambulatory surgical centers (ASCs), hospital outpatient departments (HOPDs), and physicians'
offices, as well as the recent inclusion of DEXTENZA into the cost performance category of the Centers for Medicare & Medicaid Services'
Merit-based Incentive Payment System (MIPS) for 2025.
The Company anticipates that net product revenue on a quarterly
basis should increase for the remainder of 2025, driven primarily by expected increases in the number of units sold, as clinicians adjust
to the impact of MIPS, and as the Company increases sales efforts directed towards HOPDs, which are receiving separate payment for DEXTENZA
in 2025 after being ineligible for separate payments in 2024.
Research and development expenses for the first quarter
of 2025 were $42.9 million versus $20.7 million for the comparable quarter in 2024, reflecting an increase in overall clinical expenses
associated with the SOL-1 and SOL-R Phase 3 clinical trials, as well as additional personnel and professional services to support these
Selling and marketing expenses were $14.1 million
for the first quarter of 2025, as compared to $10.2 million for the comparable quarter of 2024, primarily reflecting an increase in personnel-related
costs, including stock-based compensation expense, and professional fees associated with pre-commercialization activities for AXPAXLI.
General and administrative expenses were $16.3 million
for the first quarter of 2025, as compared to $14.1 million for the comparable quarter of 2024, primarily due to an increase in personnel-related
costs, including stock-based compensation expense.
Net loss for the first quarter of 2025 was $(64.1) million,
or a net loss of $(0.38) per share on both a basic and diluted basis, compared to a net loss of $(64.8) million, or a net
loss of $(0.49) per share on a basic and diluted basis, for the comparable quarter of 2024. The net loss in the first quarter
of 2025 includes a net loss from the change in fair value of our derivative liability of $(1.0) million, which is comprised of a non-cash
loss from fair value measurement of the derivative liability associated with the Barings Credit Facility of $(0.6) million, and expense
related to actual royalty fees under the Barings Credit Facility of $(0.4) million, compared to a $(5.2) million net loss for the first
quarter of 2024, which is comprised of a net non-cash loss attributable to fair value measurements of the derivative liabilities associated
with the Barings Credit Facility and the Company's convertible notes of $(4.6) million, and expense related to actual royalty fees under
the Barings Credit Facility of $(0.5) million.
Outstanding shares as of May 1, 2025, were approximately
known as OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target,
tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD, diabetic retinopathy, diabetic
macular edema, and other retinal diseases.
About the SOL-1 Study
The registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked,
randomized (1:1), parallel group study that involves more than 100 clinical trial sites located in the U.S. and Argentina. In December
2024, the trial completed randomization of 344 evaluable treatment-na ve subjects with a diagnosis of wet AMD in the study eye.
The superiority study has an eight-week loading segment prior to
randomization. During the loading segment, subjects who have 20/80 vision or better and who satisfy other enrollment criteria
receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Eligible subjects who achieve best corrected visual acuity (BCVA) of
20/20 at Day 1 or gain at least 10 early treatment diabetic retinopathy study (ETDRS) letters at Day 1 are then randomized to
receive a single dose of AXPAXLI or a single dose of aflibercept (2 mg). At Week 52 and at Week 76, all subjects are re-dosed with
their respective initial treatment of AXPAXLI or aflibercept (2 mg). Subjects will be followed for safety until the end of Year 2.
Throughout the study, subjects are assessed monthly. Trial subjects and designated study personnel will remain masked through the
end of Year 2. The clinical trial protocol requires that, during the study, subjects in either arm meeting pre-specified rescue
criteria will receive a supplemental dose of aflibercept (2 mg).
The primary endpoint of SOL-1 is the proportion of subjects who maintain
visual acuity, defined as a loss of <15 ETDRS letters of BCVA, at Week 36. Subjects will continue to be evaluated for durability up
to Week 52. The study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
About the SOL-R Study
The registrational Phase 3 SOL-R trial (NCT06495918) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked,
randomized (2:2:1), three-arm study that will involve sites located in the U.S. and the rest of the world. The trial is intended to randomize
approximately 555 subjects who are treatment-na ve or were diagnosed with wet AMD in the study eye within about four months prior
This non-inferiority trial reflects a patient enrichment strategy over
the six months prior to randomization that includes three screening doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and monitoring
to exclude those subjects with significant retinal fluid fluctuations. Subjects that continue to meet eligibility will enter a run-in
period and receive two loading doses of aflibercept (2 mg) prior to Day 1. Subjects in the first arm receive a single dose of AXPAXLI
at Day 1 and are re-dosed at Weeks 24, 48, and 72. Subjects in the second arm receive aflibercept (2 mg) on-label every eight weeks. Subjects
in the third arm receive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Weeks 24, 48, and 72, aligned with the AXPAXLI
treatment arm for adequate masking. Subjects will be followed for safety until the end of Year 2. Throughout the study, subjects are assessed
monthly. Trial subjects and designated study personnel will remain masked through the end of Year 2. Subjects in any arm that meet pre-specified
rescue criteria will receive a supplemental dose of aflibercept (2 mg). The pre-specified rescue criteria include loss of 10 letters
of BCVA from baseline or a combination of worsening anatomical measures and BCVA loss.