Apellis Pharmaceuticals Reports Third Quarter 2019 Business Update and Financial Results
November 5, 2019
Dosed First Patient in Phase 3 Study of APL-2 for Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Cash Position of
“Apellis made continued clinical and business progress in the third quarter of 2019, highlighted by dosing the first patient in the Phase 3 PRINCE study for treatment-naïve patients with PNH and significantly extending our cash runway through a convertible senior notes offering,” said
Business Highlights and Upcoming Milestones:
APL-2 in Systemic Indications
October 2019, Apellis announced it will present preliminary clinical data on APL-2 (pegcetacoplan) in C3 glomerulopathy (C3G) at the American Society of Nephrology Kidney Week2019 in Washington D.C.from Nov. 5-10. Data from eight patients in the C3G cohort of the Phase 2 DISCOVERY trial of APL-2 will be presented through study day 84 (12 weeks).
September 2019, Apellis announced the dosing of the first patient in the Phase 3 clinical study, PRINCE (APL2-308), evaluating the efficacy and safety of APL-2 for treatment-naïve patients with PNH. The PRINCE study is a randomized, multicenter, open-label, controlled study that aims to enroll 54 treatment-naïve adult patients with PNH.
- Apellis met with regulatory authorities this fall to discuss the program in cold agglutinin disease (CAD). The company will update plans and timing for further clinical development of APL-2 for patients with CAD in early 2020.
APL-2 in Geographic Atrophy
September 2019, details about the company’s Phase 2 FILLY study investigating intravitreal APL-2 for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration were published in Ophthalmology, the journal of the American Academy of Ophthalmology.
- Apellis continues to expect its two Phase 3 trials for APL-2 in patients with GA will be fully enrolled by the end of the first quarter of 2020.
Corporate & Other Highlights
September 2019, Apellis announced the closing of its offering of $220.0 millionaggregate principal amount of 3.500% convertible senior notes due 2026. The notes are convertible into cash, shares of Apellis common stock, or a combination of cash and shares of Apellis common stock, at Apellis’ election.
Third Quarter 2019 Financial Results:
Apellis reported a net loss of
Research and development expenses were
General and administrative expenses were
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the implications of preliminary clinical data. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether the Company’s clinical trials will be fully enrolled and completed when anticipated; whether preliminary or interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials will be indicative of results that will be generated in future clinical trials; whether APL-2 will successfully advance through the clinical trial process on a timely basis, or at all; whether the results of such clinical trials will warrant regulatory submissions and whether APL-2 will receive approval from the
|APELLIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|December 31,||September 30,|
|Cash and cash equivalents||$||176,267,666||$||433,994,644|
|Other current assets||1,837,704||2,457,530|
|Total current assets||202,439,221||451,194,872|
|Property and equipment, net||977,918||1,592,787|
|Liabilities and Stockholders' Equity|
|Current portion of long-term debt||1,666,667||-|
|Current portion of right of use liabilities||—||2,304,147|
|Total current liabilities||17,024,607||44,572,363|
|Convertible senior notes||—||140,614,523|
|Development derivative liability||—||130,103,000|
|Term loan facility||18,722,321||-|
|Preferred stock, $0.0001 par value; 10,000,000 shares authorized, and zero shares issued and outstanding at December 31, 2018 and September 30, 2019||—||—|
|Common stock, $0.0001 par value; 200,000,000 shares authorized at December 31, 2018 and September 30, 2019 and 56,279,307 shares issued and outstanding at December 31, 2018 and 63,872,762 shares issued and outstanding at September 30, 2019||5,628||6,387|
|Additional paid in capital||437,855,681||608,015,713|
|Accumulated other comprehensive loss||(122,807||)||(205,249||)|
|Total stockholders' equity||160,972,655||139,561,814|
|Total liabilities and stockholders' equity||$||203,533,559||$||466,356,957|
|APELLIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||29,539,456||$||51,319,017||$||74,479,965||$||142,497,342|
|General and administrative||6,265,125||18,628,945||16,248,203||39,577,627|
|Loss on extinguishment of debt||—||(293,083||)||—||(1,501,215||)|
|Loss from remeasurement of development derivative liability||—||(263,000||)||—||(10,103,000||)|
|Other (expense)/income, net||(22,234||)||(61,048||)||(86,575||)||(85,941||)|
|Other comprehensive gain:|
|Foreign currency gain||(86,249||)||(83,272||)||(86,249||)||(82,442||)|
|Total other comprehensive gain||(86,249||)||(83,272||)||(86,249||)||(82,442||)|
|Comprehensive loss, net of tax||$||(35,632,173||)||$||(69,907,931||)||$||(90,702,778||)||$||(191,571,632||)|
|Net loss per common share, basic and diluted||$||(0.64||)||$||(1.10||)||$||(1.69||)||$||(2.79||)|
|Weighted-average number of common shares used in net loss per common share, basic and diluted||56,201,299||63,752,719||53,770,400||68,737,045|
Source: Apellis Pharmaceuticals, Inc.