Apellis Pharmaceuticals, Inc. - APLS STOCK NEWS

Apellis Pharmaceuticals (Nasdaq: APLS) has announced the approval of equity awards for one new employee, effective October 1, 2024. These awards, granted outside the company's 2017 Stock Incentive Plan but under the 2020 Inducement Stock Incentive Plan, are in compliance with Nasdaq Listing Rule 5635(c)(4). The employee received 4,240 restricted stock units (RSUs). The vesting schedule for these RSUs is as follows:

• 25% of the shares will vest on the first anniversary of the grant date
• An additional 25% will vest annually thereafter

Vesting is subject to the employee's continued employment on each vesting date. These equity awards are considered material to the employee's acceptance of employment with Apellis Pharmaceuticals.

Apellis Pharmaceuticals (Nasdaq: APLS) has announced its participation in the UBS Virtual Ophthalmology Day. The company will host a fireside chat on Wednesday, October 2, 2024, at 8:30 a.m. ET. This event will be accessible through a live webcast on the company's website, specifically on the "Events and Presentations" page within the "Investors and Media" section.

For those unable to attend the live event, Apellis will provide a replay of the webcast, which will remain available for approximately 90 days following the event. This virtual participation underscores Apellis' commitment to engaging with investors and industry professionals in the ophthalmology sector.

Apellis Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its negative opinion on the marketing authorization application of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration in the EU.

The company expressed disappointment with the decision, which leaves millions of Europeans with GA without a treatment option. Despite support from the European retina community and dissenting votes from some CHMP members, the negative opinion was upheld. Apellis remains committed to expanding access to pegcetacoplan in other regions globally, focusing on unmet patient needs in the U.S. and elsewhere.

GA is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, affecting over five million people globally. Pegcetacoplan is approved in the United States under the brand name SYFOVRE® for the treatment of GA secondary to age-related macular degeneration.

Apellis Pharmaceuticals (Nasdaq: APLS) has announced the approval of equity inducement awards for one new employee, effective September 3, 2024. The grants, made outside the company's 2017 Stock Incentive Plan but under the 2020 Inducement Stock Incentive Plan, comply with Nasdaq Listing Rule 5635(c)(4). The employee received 1,015 restricted stock units (RSUs). These RSUs will vest over four years, with 25% vesting on the first anniversary of the grant date and an additional 25% annually thereafter, contingent on continued employment.

Apellis Pharmaceuticals (Nasdaq: APLS) has announced its participation in two upcoming investor conferences in September 2024. The company will be featured in fireside chats at the Wells Fargo Annual Healthcare Conference on September 5 at 9:30 a.m. ET and the Baird 2024 Global Healthcare Conference on September 11 at 9:05 a.m. ET.

Investors and interested parties can access live webcasts of these presentations through the 'Events and Presentations' page in the 'Investors and Media' section of Apellis' website. Replays of the webcasts will be available for approximately 90 days after the events, providing an opportunity for those unable to attend live to catch up on the company's latest updates and insights.

Apellis Pharmaceuticals (Nasdaq: APLS) and Sobi announced positive topline results from the Phase 3 VALIANT study of pegcetacoplan in C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study met its primary endpoint, showing a statistically significant 68% reduction in proteinuria compared to placebo at Week 26. Results were consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys.

Pegcetacoplan also demonstrated significance on key secondary endpoints and favorable safety. Apellis plans to submit a supplemental new drug application to the FDA in early 2025, while Sobi plans to submit a marketing application with the EMA in 2025.

Apellis Pharmaceuticals (Nasdaq: APLS), a global biopharmaceutical company specializing in complement therapies, has announced the approval of equity inducement awards for one new employee. The grants, made outside the company's 2017 Stock Incentive Plan but under the 2020 Inducement Stock Incentive Plan, were approved on August 1, 2024, in accordance with Nasdaq Listing Rule 5635(c)(4).

The employee received 1,015 restricted stock units (RSUs). These RSUs will vest over four years, with 25% vesting on the first anniversary of the grant date and an additional 25% vesting annually thereafter, contingent on the employee's continued employment.

Apellis Pharmaceuticals (Nasdaq: APLS) announced its Q2 2024 financial results, generating $199.7 million in revenue, a significant increase from $95 million in Q2 2023. U.S. net product sales included $154.6 million from SYFOVRE and $24.5 million from EMPAVELI. Cost of sales rose to $23.1 million, while R&D expenses decreased to $78 million. SG&A expenses increased to $128.1 million. Net loss narrowed to $37.7 million from $122 million in Q2 2023. The company holds $360.1 million in cash and anticipates reaching positive cash flow.

Notable milestones include the re-examination of SYFOVRE's marketing application by the EMA, expected by Q4 2024, and upcoming Phase 3 trial data for systemic pegcetacoplan in C3G/IC-MPGN in August 2024. SYFOVRE remains market leader in GA with over 84,000 doses delivered in Q2 2024. EMPAVELI shows high patient compliance at 97%.

Apellis Pharmaceuticals (Nasdaq: APLS) has announced a conference call and webcast to discuss its second quarter 2024 financial results on August 1, 2024, at 8:30 a.m. ET. Investors can pre-register for the call, and a live audio webcast with accompanying slides will be available on the company's website. A replay will be accessible for 90 days following the event.

Apellis is a global biopharmaceutical company focused on developing therapies for challenging diseases. They have introduced the first new class of complement medicine in 15 years and have two approved medicines targeting C3, including the first-ever therapy for geographic atrophy, a leading cause of blindness worldwide. The company aims to further explore C3 targeting across retinal, rare, and neurological diseases.