Full Press Release Details
Therapeutix Reports Fourth Quarter and Full Year 2024 Results and Business Highlights
updates to enhance and accelerate AXPAXLI registrational program in wet AMD, potentially supporting label flexibility of 6-12 months
to showcase expected best-in-class durability
Amendment to SOL-1 Special Protocol Agreement (SPA) to include AXPAXLI re-dosing at Weeks 52 and 76
36 primary endpoint data now expected in 1Q 2026 due to requirement for masking until Week 52 to allow for re-dosing
re-dosing in SOL-1, along with exceptional retention seen to date in the study, paves way for reduction of SOL-R trial size to 555 subjects
(previously 825), potentially accelerating registration timelines
provided on SOL-R non-inferiority margin and rescue criteria
of $392.1M as of December 31, 2024, expected to fund operations into 2028 and the Company currently does not intend to raise additional
on clinical trial design for AXPAXLI in NPDR and DME expected in 1H 2025
a 4Q 2024 conference call and webcast today, March 3rd, at 8:00 AM ET
BEDFORD, MA, March 3, 2025 (GLOBE
NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular"), a biopharmaceutical company committed to redefining
the retina experience, today reported financial results for the fourth quarter and year ended December 31, 2024 and provided recent
business highlights, including updates to the registrational program for AXPAXLI (axitinib intravitreal hydrogel) in wet age-related
macular degeneration (wet AMD) designed to accelerate a potential path to NDA submission and increased label flexibility.
"2024 was a transformative year
for Ocular Therapeutix. We sharpened our focus on a single, bold mission - to redefine the retina experience - starting with
wet AMD as our top priority. Despite effective treatments today, the burden of frequent pulsatile dosing leads to high dropout rates
and poor long-term visual outcomes. AXPAXLI has the potential to disrupt this paradigm by offering a more sustainable solution and possibly
improve long-term outcomes. And we see wet AMD as just the beginning. There is a significant opportunity to expand into non-proliferative
diabetic retinopathy (NPDR) and diabetic macular edema (DME), along with several other retinal diseases, where millions remain untreated,"
said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. "We're
executing not only with speed but also with precision. Today we announced key updates designed to accelerate our path to NDA submission
while maintaining strong study integrity and alignment with FDA guidance. By incorporating 52-week and 76-week re-dosing in SOL-1, we
anticipate a label supporting dosing every 6-12 months, reinforcing AXPAXLI's potential best-in-class durability. Equally important
is the exceptional retention we have seen to date in SOL-1. The combination of this outstanding retention and the addition of re-dosing
in SOL-1 allows us to reduce the size of SOL-R while ensuring it remains well-powered for success. Trial conduct for both studies remains
a top priority, and we are pleased to see the vast majority of SOL-1 rescue treatments continue to track in line with the pre-specified
criteria in the protocol. Ultimately, these trials were developed to be complementary and to de-risk the clinical trials' patient
populations in a bespoke manner. We expect the complementary nature of the two trials will continue to provide us with a significant
advantage in our regulatory and registrational strategy as we prepare for potential commercialization."
Dr. Dugel concluded, "We
have started 2025 with confidence and conviction, backed by a world-class team, a groundbreaking asset, strong trial momentum, and a
substantial capital position providing runway into 2028 with no plans to raise additional capital this year. With our registrational
program for AXPAXLI making significant progress in wet AMD and plans coming into focus this year for NPDR and DME, we believe we are
well on our way to becoming a leading retina company."
Recent Achievements and Upcoming
non-inferiority trial comparing AXPAXLI, administered every 24 weeks, to aflibercept (2 mg), administered every eight weeks. The
primary endpoint is the mean change in best corrected visual acuity (BCVA) at Week 56. As per the protocol agreed to by the FDA, the
non-inferiority margin for the lower bound is -4.5 letters of mean BCVA when compared to aflibercept (2 mg) dosed every eight weeks.
This is also in line with the FDA draft guidance, which Ocular is adhering to by including an aflibercept (8 mg) masking comparator
arm with the exact same dosing frequency as the AXPAXLI arm.
"We designed the SOL program to
answer the most relevant questions a retina specialist may have about durability, flexibility, and repeatability of AXPAXLI in wet AMD.
These complementary studies were built with a strong scientific rationale and close alignment with the FDA," said Nadia K. Waheed,
MD, Chief Medical Officer of Ocular Therapeutix. "SOL-1 is a superiority study evaluating whether more subjects maintain vision
at Week 36 with AXPAXLI versus a single aflibercept (2 mg) injection. Our primary endpoint remains at Week 36, but we will wait until
Week 52 to unmask the data so that we can conduct all predefined assessments in a masked manner. The subjects will then be re-treated
with AXPAXLI or aflibercept (2 mg) at Week 52 and again at Week 76. SOL-R, on the other hand, is a non-inferiority study assessing AXPAXLI
every 24 weeks versus aflibercept (2 mg) every eight weeks. We initially aimed to randomize 825 patients to meet the FDA's re-dosing
requirements for AXPAXLI. With re-dosing now included in SOL-1, we can streamline SOL-R to randomize 555 patients while maintaining strong
powering assumptions to achieve the non-inferiority margin for the lower bound of -4.5 letters of mean BCVA when compared to aflibercept
Fourth Quarter and Full Year Ended
December 31, 2024, Financial Results:
Total cash and cash equivalents
were $392.1 million as of December 31, 2024. 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 potential impact of clinical trial activities for AXPAXLI
in NPDR and DME, however the Company currently does not intend to raise additional capital this year.
Total net revenue was $17.1
million for the fourth quarter of 2024, a 15.4% increase over total net revenue of $14.8 million in the comparable quarter in 2023.
Total net revenue for the full year 2024 was $63.7 million versus $58.4 million in 2023, an increase of 9.0%. This increase was driven
by increased gross revenues from DEXTENZA sales, partially offset by higher gross-to-net provisions in the 2024 period compared to the
prior year. 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.
Research and development
expenses for the fourth quarter of 2024 were $41.0 million versus $16.2 million for the comparable quarter in 2023, 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 clinical trials. Overall R&D expenses for the full year 2024
increased to $127.6 million from $61.1 million in 2023, reflecting the timing and conduct of the Company's
clinical trials as well as additional personnel and professional services to support these clinical trials.
Selling and marketing expenses
were $10.8 million for the fourth quarter of 2024, as compared to $9.2 million for the comparable quarter of 2023, primarily reflecting
an increase in professional fees. Overall, selling and marketing expenses for the full year 2024 increased to $41.6 million from $40.5
million for 2023, primarily related to an increase in professional fees.
General and administrative expenses
were $14.6 million for the fourth quarter of 2024, as compared to $8.0 million for the comparable quarter of 2023, primarily due
to an increase in personnel-related costs, including stock-based compensation. Overall, general and administrative expenses for the full
year 2024 increased to $60.7 million from $33.9 million for 2023, primarily due to an increase in personnel-related costs, including
stock-based compensation, professional fees including legal costs, and other facilities and IT related costs.
Net loss for the fourth quarter of
2024 was $(48.4) million, or a net loss of $(0.29) per share on both a basic and diluted basis, compared to a net
loss of $(29.2) million, or a net loss of $(0.35) per share on a basic and diluted basis, for the comparable quarter of
2023. The net loss in the fourth quarter of 2024 includes a net gain from the change in fair value of the Company's derivative liability of $0.6
million, which comprises a non-cash gain from fair value measurement of the derivative liability associated with the Barings Credit
Facility of $1.2 million, partially offset by expense related to actual royalty fees under the Barings Credit Facility of $0.6 million,
compared to a $(6.5) million net loss for the fourth quarter of 2023, which comprises a 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 $6.0 million, and expense
related to actual royalty fees under the Barings Credit Facility of $0.5 million.
Overall, the Company reported a net
loss of $(193.5) million, or a loss of $(1.22) per share on a basic and diluted basis, for the year ended December 31, 2024 versus
a net loss of $(80.7) million, or a loss of $(1.01) per basic share and $(1.02) per diluted share, for the year ended December 31,
Outstanding shares as of February 27,
2025, were approximately 159.0 million.
Conference Call and Webcast Information:
Ocular Therapeutix will host a conference
call and webcast today at 8:00 AM ET to discuss recent business progress and fourth quarter 2024 financial results. To access the call,
please dial: 1 (877) 407-9039 (United States) or 1 (201) 689-8470 (International), and reference Conference ID 13750940.
The live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section