Ocular Therapeut - OCUL STOCK NEWS

Ocular Therapeutix (NASDAQ: OCUL), a biopharmaceutical company focused on improving vision through innovative therapies, has announced the granting of inducement awards to four newly hired employees. These awards, made under Ocular's 2019 Inducement Stock Incentive Plan, include:

1. Non-statutory stock options to purchase up to 132,400 shares of Ocular's common stock, with a ten-year term and a four-year vesting schedule.

2. Restricted stock unit awards representing the right to receive 44,133 shares of Ocular's common stock, with a three-year vesting schedule.

The grants, effective August 5, 2024, are designed to incentivize new employees and comply with Nasdaq Listing Rule 5635(c)(4).

Ocular Therapeutix (NASDAQ: OCUL) reported Q2 2024 results and provided updates on its AXPAXLI™ wet AMD program. Key highlights include:

1. FDA confirmed SOL-R repeat dosing study is acceptable as a registrational trial
2. SOL-1 enrollment accelerating; SOL-R actively enrolling patients
3. Cash balance of $459.7M as of June 30, 2024, expected to fund operations into 2028
4. Q2 2024 total net revenue: $16.4M, up 8.3% YoY
5. Full-year 2024 DEXTENZA revenue guidance: $62.0M - $67.0M
6. Q2 2024 net loss: $(43.8M) or $(0.26) per share

The company remains focused on becoming a leader in retinal disease treatment, with promising progress in its AXPAXLI clinical trials for wet AMD and NPDR.

Ocular Therapeutix (NASDAQ: OCUL) has received FDA confirmation that its Phase 3 SOL-R clinical trial is suitable as a registrational study for AXPAXLI™ (axitinib intravitreal implant) in treating wet age-related macular degeneration (wet AMD). The FDA agreed that using one superiority study (SOL-1) and one non-inferiority study (SOL-R) is acceptable for a potential New Drug Application. SOL-R evaluates repeat dosing of AXPAXLI every six months compared to standard aflibercept treatment. This development clarifies the regulatory path for AXPAXLI in wet AMD, potentially offering a new treatment paradigm with long-term visual improvements through durable VEGF suppression.

Ocular Therapeutix (NASDAQ:OCUL), a biopharmaceutical company focused on developing innovative therapies for retinal diseases and other eye conditions, has announced its plans to host a conference call and webcast on August 7, 2024, at 8:00 AM ET. The event will cover recent business progress and financial results for the second quarter ended June 30, 2024.

Participants can join the call using the following details:

• U.S. Dial-In: 1 (800) 343-4136
• International Dial-in: 1 (203) 518-9843
• Conference ID: OCULAR

Ocular Therapeutix (NASDAQ: OCUL) has initiated patient enrollment in the Phase 3 SOL-R clinical trial for AXPAXLI™, evaluating its efficacy in treating wet age-related macular degeneration (wet AMD). This global study involves 825 patients and aims to demonstrate non-inferiority of AXPAXLI dosed every six months compared to 2 mg aflibercept dosed every eight weeks. The trial includes a third arm with 8 mg aflibercept dosed every six months for masking purposes.

SOL-R complements the ongoing SOL-1 trial, focusing on repeat dosing to reflect real-world treatment scenarios. It will initially enroll patients ineligible for SOL-1, later expanding to include treatment-naïve patients or those recently diagnosed with wet AMD. The study design incorporates multiple aflibercept loading doses and evaluates patients to limit retinal fluid fluctuations, potentially increasing the likelihood of success.

Ocular Therapeutix (NASDAQ:OCUL), a biopharmaceutical company focused on developing therapies for eye diseases, has announced inducement awards for its new Senior Vice President and Chief of Staff, Chad Clatterbaugh. The awards, granted under Ocular's 2019 Inducement Stock Incentive Plan, include:

1. A non-statutory stock option to purchase 110,000 shares of Ocular's common stock, vesting over four years.

2. A restricted stock unit award for 36,666 shares, vesting over three years.

These awards are designed to incentivize Mr. Clatterbaugh's employment and are subject to his continued service with Ocular. The grants comply with Nasdaq Listing Rule 5635(c)(4) and were effective as of July 12, 2024.

Ocular Therapeutix announced the acceptance of a late-breaking abstract related to their Phase 1 HELIOS study for presentation at the 42nd ASRS Annual Scientific Meeting. The study evaluates AXPAXLI, an axitinib intravitreal implant, for non-proliferative diabetic retinopathy (NPDR). The presentation, titled 'Interim Safety and Efficacy Results From the Phase 1 HELIOS Trial of Sustained-release Axitinib Implant (OTX-TKI) for NPDR', is scheduled for July 18, 2024, during the Diabetic Retinopathy Symposium 2 at 10:47 – 10:51 AM CEST. Dr. Dilsher S. Dhoot will present the interim findings emphasizing the potential of AXPAXLI in treating NPDR.

Ocular Therapeutix announced the grant of inducement awards to its newly appointed Director of Statistical Programming, Yong Rao, and three other new employees, under its 2019 Inducement Stock Incentive Plan. The awards comply with Nasdaq Listing Rule 5635(c)(4). Effective July 1, 2024, Mr. Rao received a non-statutory stock option to purchase up to 20,000 shares and a restricted stock unit award for 6,666 shares. The stock options have a ten-year term and vest over four years, while the restricted stock units vest over three years.

Additionally, the three new employees received stock options for up to 38,800 shares and restricted stock unit awards for 12,933 shares. These stock options also have a ten-year term and vest over four years, with the restricted stock units vesting over three years. All awards are contingent on continued service to the company.

Ocular Therapeutix reported significant progress in its AXPAXLI clinical studies and corporate strategy at its recent Investor Day. As of June 7, 2024, 151 subjects have enrolled in the SOL-1 study for wet AMD, with plans for a new repeat dosing study, SOL-R. The SOL-1 study, under an FDA Special Protocol Assessment, aims to compare a single AXPAXLI implant to aflibercept injections. The company disclosed positive 48-week data from the HELIOS NPDR study, showing a ≥2-step DRSS improvement in 23.1% of AXPAXLI-treated patients without vision-threatening complications.

Ocular has also fortified its balance sheet to support operations through 2028 and has strategically streamlined its organization. The company aims to de-risk AXPAXLI’s regulatory pathway and focus on expansive retinal disease markets, confident in the drug's safety and potential best-in-class durability.