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Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) is a commercial-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapeutic compounds. The company's primary focus is on treating diseases with high unmet medical needs through the inhibition of the complement system, a crucial part of the immune system. Apellis targets the complement system at the level of C3, aiming to provide comprehensive disease control.
Apellis's flagship products include SYFOVRE® (pegcetacoplan injection) and EMPAVELI® (pegcetacoplan). SYFOVRE is the first-ever approved therapy for geographic atrophy (GA), a leading cause of blindness, while EMPAVELI is approved for treating paroxysmal nocturnal hemoglobinuria (PNH), a rare hematological disease. Both medicines reflect the company's innovative approach to complement immunotherapy.
In 2023, Apellis achieved significant milestones, including generating $397 million in revenue, with substantial contributions from SYFOVRE and EMPAVELI. The company has also presented positive data from its Phase 2 NOBLE study for systemic pegcetacoplan in rare kidney diseases at the European Renal Association Congress, highlighting the potential of pegcetacoplan to address complex medical conditions.
Looking ahead, Apellis anticipates regulatory developments, including the European Medicines Agency’s (EMA) review of the marketing authorization application (MAA) for SYFOVRE and the expected topline data from the Phase 3 VALIANT study of systemic pegcetacoplan in mid-2024. Financially robust, Apellis recently closed a $375 million funding deal with Sixth Street to buy out existing liabilities, significantly improving its liquidity profile and positioning the company for sustainable growth.
Apellis's commitment to advancing science is evident through its extensive pipeline and collaborations, such as its partnership with Sobi for systemic pegcetacoplan. The company's approach combines bold scientific endeavors with compassionate patient care, continually striving to bring life-changing therapies to those in need.
Apellis Pharmaceuticals (APLS) and Sobi have announced a positive opinion from the European Medicines Agency's CHMP for Aspaveli® (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) who remain anemic after at least three months on a C5 inhibitor. This recommendation is now forwarded to the European Commission for review. Aspaveli aims to provide a new treatment option for the approximately 72% of patients still anemic after C5 therapy. This follows recent U.S. approval for the same indication, which could significantly impact treatment paradigms for PNH in Europe.
Apellis Pharmaceuticals (APLS) announced the grant of equity awards to three new employees, effective October 1, 2021. The awards include options for 32,000 shares and 1,000 restricted stock units (RSUs), with an exercise price of $33.59, matching the stock's closing price on the grant date. The options will vest over four years, while the RSUs will vest 25% annually. This action, aligned with Nasdaq Listing Rule 5635(c)(4), is a strategic move to attract talent critical for the company's growth in targeted C3 therapies.
Apellis Pharmaceuticals (APLS) presented Phase 3 study results for pegcetacoplan, a targeted C3 therapy, at the Retina Society Annual Scientific Meeting. The OAKS trial showed significant reduction in geographic atrophy (GA) lesion growth with monthly (p=0.0003) and every-other-month (p=0.0052) treatments. The DERBY trial showed a reduction in lesion growth but narrowly missed the primary endpoint. Pegcetacoplan could become the first treatment for GA, which affects over five million globally. An NDA is planned for submission in H1 2022.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in the 2021 Cantor Virtual Global Healthcare Conference, scheduled for September 27, 2021, at 8:40 a.m. ET. The conference will be conducted virtually and accessible via a live webcast on the company’s website. A replay will be available for 90 days post-event. Apellis, a leader in targeted C3 therapies, focuses on transformative solutions for diseases caused by complement cascade activation.
Apellis Pharmaceuticals, Inc. (APLS) announced positive results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan for geographic atrophy (GA) due to age-related macular degeneration (AMD). In the OAKS study, pegcetacoplan achieved its primary endpoint, reducing GA lesion growth by 22% (p=0.0003) monthly and 16% (p=0.0052) every-other-month. Conversely, DERBY did not meet its primary endpoint, exhibiting lesser reductions. Overall, pegcetacoplan demonstrated a 26% reduction in lesion growth among patients with extrafoveal lesions. Aiming for FDA approval, Apellis plans to submit a New Drug Application in early 2022.
Apellis Pharmaceuticals (Nasdaq: APLS) announced the grant of equity awards to a new employee effective September 1, 2021, as part of their 2021 Inducement Stock Incentive Plan. The awarded equity includes options to purchase 1,000 shares at an exercise price of $64.73, the closing price on the grant date, and 500 restricted stock units (RSUs). The options will vest over four years, while the RSUs will vest annually over four years, contingent on continued employment. This move aims to incentivize talent acquisition in line with Nasdaq Listing Rule 5635(c)(4).
On September 3, 2021, Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity awards for Jim Chopas, its newly appointed VP, Corporate Controller / Chief Accounting Officer. The award includes options to purchase 21,750 shares at an exercise price of $65.41, equal to the stock's closing price on the grant date. Additionally, 7,600 restricted stock units (RSUs) were granted. The vesting schedule for both options and RSUs is contingent on Chopas' continued employment with the company. This appointment aligns with Nasdaq Listing Rule 5635(c)(4).
Apellis Pharmaceuticals (APLS) received FDA approval for EMPAVELI™, the first targeted C3 therapy for adults with paroxysmal nocturnal hemoglobinuria (PNH), and initiated a U.S. commercial launch. The company reported $0.6 million in net product revenue for Q2 2021, marking its first sales since EMPAVELI's approval. Additionally, positive results were announced from the Phase 3 PRINCE study, indicating statistical superiority in key endpoints. Apellis continues to expand its pipeline and has entered into a collaboration with Beam Therapeutics for new therapies.
Apellis Pharmaceuticals (Nasdaq: APLS) announced on August 6, 2021, that it approved equity awards for three new employees. The awards consist of options to purchase 75,100 shares and 5,050 restricted stock units (RSUs), granted under the 2021 Inducement Stock Incentive Plan. The options have an exercise price of $63.25, equal to the stock's closing price on the grant date. The vesting schedule includes a one-year cliff and monthly vesting thereafter for options, while RSUs vest 25% annually. This move aims to attract talent to support growth and innovation.
Apellis Pharmaceuticals (Nasdaq: APLS) plans to host a conference call and webcast on August 9, 2021, at 4:30 p.m. ET to discuss its second quarter 2021 financial results. Participants can join via phone or through the company’s website. A 90-day replay of the webcast will be accessible post-event. Apellis focuses on targeted C3 therapies and aims to develop transformative treatments for diseases driven by excessive complement activation. More information is available at www.apellis.com.