Apellis Pharmaceuticals Reports First Quarter 2018 Business Update and Financial Results
April 30, 2018
- APL-2 in Geographic Atrophy (GA) and Paroxysmal Nocturnal Hemoglobinuria (PNH) On Track to Advance into Phase 3 Trials in 2H18 -
- Cash Position of
“The first quarter of 2018 set the foundation for advancement across our clinical programs, and was marked by the positive 18-month results of the Phase 2 FILLY trial of APL-2 in patients with GA. Shortly after quarter end, we announced encouraging interim results of APL-2 in patients with PNH naïve to eculizumab, showing a reduction in lactate dehydrogenase, an increase in hemoglobin levels and improvements in other markers for anemia,” said
Business Highlights and Upcoming Milestones:
APL-2 in Geographic Atrophy
- Reported 18-month data on its Phase 2 FILLY trial of APL-2 in patients with GA in
- The Phase 3 trial of APL-2 in GA remains on track to begin in the second half of 2018.
APL-2 in PNH
- Recently reported interim data from its Phase 1b PADDOCK trial in patients with PNH. The interim data showed APL-2 has generally been well-tolerated to date, reduced lactate dehydrogenase, increased hemoglobin levels and also showed substantial improvements in other biomarkers of anemia in patients not previously treated with eculizumab (Soliris).
- The Phase 3 trial of APL-2 in PNH remains on track to begin in the second half of 2018.
APL-2 In Other Indications
- The Phase 2 proof-of-concept (POC) monotherapy data for APL-2 in AIHA remains on track for the first half of 2018.
- The Phase 2 POC monotherapy data for APL-2 in four types of complement-dependent nephropathies, including IgA nephropathy, C3 glomerulonephropathy, primary membranous nephropathy, and lupus nephritis, are expected in the second half of 2018.
First Quarter 2018 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 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 such as the results referenced in this release 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 submission; whether APL-2 will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if Apellis’ products receive approval, they will be successfully distributed and marketed; whether Apellis’ cash resources will be sufficient to fund the company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 19, 2018, and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
|APELLIS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|Three Months Ended|
|Research and development||$||7,231,084||$||17,402,890|
|General and administrative||1,821,409||4,035,255|
|Interest income (expense), net||10,112||(266,686||)|
|Other income, net||(8,392||)||(31,473||)|
|Net loss and comprehensive loss||$||(9,050,773||)||$||(21,736,304||)|
|Net loss per common share, basic and diluted||$||(1.07||)||$||(0.43||)|
|Weighted-average number of common shares used in net|
|loss per common share, basic and diluted||8,428,366||50,353,812|
|APELLIS PHARMACEUTICALS, INC.|
|CONSOLIDATED BALANCE SHEETS|
|December 31,||March 31,|
|Cash and cash equivalents||$||175,643,529||$||152,930,977|
|Refundable research and development credit||1,297,361||1,828,565|
|Other current assets||14,823||205,713|
|Total current assets||182,015,306||163,086,857|
|Liabilities and Stockholders' Equity|
|Total current liabilities||6,553,958||7,294,859|
|Term loan facility||19,806,944||20,015,568|
|Promissory note - related party||6,583,402||6,600,475|
|Common stock warrant liability||244,292||250,000|
|Preferred stock, $0.0001 par value; zero shares authorized, issued and
outstanding at December 31, 2016 and 10,000,000 shares authorized,
and zero shares issued and outstanding at December 31, 2017
|Common stock, $0.0001 par value; 87,000,000 shares authorized and
8,428,366 shares issued and outstanding at December 31, 2016 and
200,000,000 shares authorized and 50,334,152 shares issued and
outstanding at December 31, 2017
|Additional paid in capital||298,201,480||300,037,020|
|Total stockholders' equity||148,942,860||129,042,105|
|Total liabilities and stockholders' equity||$||182,131,456||$||163,203,007|
Alex Kaneakane@w2ogroup.com 212.301.7218 (office) 929.400.2691 (mobile) Media Contact: Tully Nicholas firstname.lastname@example.org 617.482.0042 (office) 860.490.0218 (mobile)
Source: Apellis Pharmaceuticals, Inc.