Full Press Release Details
Ocular Therapeutix Reports Third Quarter
2024 Results and Business Highlights
SOL-1 expected to be fully randomized by YE
2024 with topline data expected in Q4 2025
Active clinical trial sites now enrolling patients
Cash balance of $427.2M as of September 30,
2024, expected to fund operations into 2028
Ocular to host a Q3 2024 conference call and
webcast today, November 14th, at 8:00 AM ET
BEDFORD, MA, November 14, 2024 (GLOBE NEWSWIRE) -- Ocular
Therapeutix, Inc. (NASDAQ: OCUL, "Ocular", the "Company"), a biopharmaceutical company committed to improving
vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions,
today reported financial results for the third quarter ended September 30, 2024 and provided recent business highlights, including
an update on the Phase 3 registrational program for AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI) in development
for wet age-related macular degeneration (wet AMD).
"2024 has been a year of significant change and tremendous execution
at Ocular, but this is all in anticipation of what's ahead. We are making outstanding progress on enrollment in the two complementary
studies in our registrational program for AXPAXLI in wet AMD, SOL-1 and SOL-R. I'm thrilled to share that SOL-1 has reached a key
enrollment milestone, as we have now flipped the switch' to allow direct enrollment of subjects into SOL-R. We expect to
complete SOL-1 randomization by year-end, with topline data to follow in the fourth quarter of 2025. As SOL-1 quickly approaches complete
randomization, eligible subjects who are not ultimately randomized can seamlessly enroll in SOL-R, creating a streamlined and efficient
pathway that capitalizes on recruitment momentum at our clinical sites," said Pravin U. Dugel, MD, Executive Chairman, President
and Chief Executive Officer of Ocular Therapeutix.
Dr. Dugel continued, "SOL-1 and SOL-R were strategically
designed with the goals of de-risking clinical outcomes, aligning with regulatory standards, enhancing each other's enrollment,
and providing a broad evaluation of AXPAXLI's durability, repeatability, and flexibility. Thanks to the team's strong execution,
attention to patient care, and long-standing relationships in the retina community, we have enrolled SOL-1 faster than we expected and
continue to build enthusiasm for SOL-R. Supported by our dedicated team and strong financial resources, Ocular is on solid footing as
we head towards what we expect will be an important milestone year in 2025."
Recent Achievements and Upcoming Milestones:
Third Quarter Ended September 30, 2024, Financial
Total cash and cash equivalents were $427.2 million as of September 30,
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, obligations, and capital expenditure requirements into 2028.
Total net revenue was $15.4 million for the third
quarter of 2024, a 2.3% increase over total net revenue of $15.1 million in the comparable period in 2023. This increase was driven by
increased gross revenues from DEXTENZA sales offset by higher gross-to-net provisions in the 2024 period compared to the prior comparable
period. The Company expects full-year 2024 total net revenues for DEXTENZA to be between $62.0 million and $67.0 million, compared to
$57.9 million reported for 2023. 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 third quarter of 2024
were $37.1 million versus $15.0 million for the comparable period in 2023, reflecting an increase in overall clinical expenses associated
with product development programs, specifically the SOL-1 and SOL-R Phase 3 clinical trials, as well as additional personnel and professional
services to support these clinical trials.
Selling and marketing expenses were $10.6 million in the third
quarter of 2024, as compared to $9.3 million for the comparable quarter of 2023, primarily reflecting an increase in professional fees
and personnel costs, including stock-based compensation.
General and administrative expenses were $12.2 million for the
third quarter of 2024 versus $8.6 million for the comparable quarter of 2023, primarily due to an increase in professional fees and personnel-related
costs, including stock-based compensation.
Net loss for the third quarter of 2024 was $(36.5) million,
or a net loss of $(0.22) per share on both a basic and diluted basis, compared to a net loss of $(0.5) million, or a net
loss of $(0.01) per share on a basic basis and $(0.25) per share on a diluted basis, for the comparable period in 2023. The
net loss in the third quarter of 2024 included a $7.6 million non-cash gain attributable to the change in the fair value of the derivative
liability associated with the Barings Credit Facility, partially offset by $0.5 million expense related to royalty fees under the Barings
Credit Facility, compared to a $7.1 million non-cash gain, net, attributable to the changes in the fair value of the derivative liability
associated with the Barings Credit Facility and the derivative liability associated with the Company's convertible notes, partially offset
by $0.4 million expense related to royalty fees under the Barings Credit Facility, for the third quarter of 2023.
Outstanding shares as of November 11, 2024, were approximately
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 third quarter 2024 financial results. To access the call, please dial: 1 (877) 407-9039
(United States) or 1 (201) 689-8470 (International). The live and archived webcast can also be accessed by visiting the Ocular
Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of the webcast will be archived for
AXPAXLI (axitinib intravitreal implant,
also known as OTX-TKI) is an investigational, bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target,
tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD, diabetic retinopathy, and other
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. The trial is intended to randomize approximately
300 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,
a 9-month treatment segment, and a safety follow-up. 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 (ETDRS) letters at Day 1 are
then randomized to receive a single dose of AXPAXLI or a single dose of aflibercept (2 mg) and assessed monthly for the duration of the
study. The clinical trial protocol requires that, during the study, subjects in any 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. The study is being conducted under a Special Protocol Agreement
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 825 subjects
who are treatment-na ve or were diagnosed with wet AMD in the study eye within three months prior to enrollment.
The non-inferiority study reflects a patient enrichment strategy that
includes multiple loading doses of aflibercept (2 mg) and monitoring to exclude subjects with significant retinal fluid fluctuations.
Subjects in the first arm receive a single dose of AXPAXLI at Day 1 and are re-dosed at Week 24. Subjects in the second arm receive aflibercept
(2 mg) on-label every 8 weeks. Subjects in the third arm receive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Week
24, aligned with the AXPAXLI treatment arm for adequate masking. Subjects in any arm that meet pre-specified rescue criteria will receive
a supplemental dose of aflibercept (2 mg).
The primary endpoint of SOL-R is non-inferiority in mean BCVA change
from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at one year. In a written Type C response received in August 2024,
the FDA agreed that the SOL-R repeat dosing wet AMD study should be appropriate as an adequate and well-controlled study in support of
a potential New Drug Application and product label.
Wet age-related macular degeneration (wet AMD) is a leading cause of
severe, irreversible vision loss affecting approximately 14 million individuals globally and 1.65 million in the United States alone (2023
Market Scope Retinal Pharmaceuticals Market Report). Wet AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability
and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor