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Resumed Dosing in Phase 3 Geographic Atrophy Program
Announced Innovative Collaboration & Financing with SFJ Pharmaceuticals®
Cash Position of $288.2 Million at Quarter-End
WALTHAM Mass. and CRESTWOOD, Ky., May 08, 2019 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals Inc., (Nasdaq:APLS) a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, today announced its first quarter 2019 financial results and business highlights.
“Apellis made considerable clinical and corporate progress during the first quarter. We resumed dosing in our Geographic Atrophy (GA) program while maintaining our original enrollment timeline guidance, strengthened our capital position and continued enrollment in the Phase 3 PEGASUS trial in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH), which we expect to fully enroll by the end of the second quarter of 2019,” said Cedric Francois, CEO and co-founder of Apellis. “The innovative collaboration with SFJ Pharmaceuticals provides Apellis with validation and substantial non-dilutive funding to develop APL-2 in hematologic diseases of complement with serious unmet need, which, along with the equity offering completed in March, solidified our capital position. The more we study APL-2, the more we understand what the unique mode of action of C3 inhibition can provide to these patients – the potential for increased survival, broad hematologic correction and clear quality of life improvement.”
Business Highlights and Upcoming Milestones:
APL-2 in GA
APL-2 in Hematologic Diseases
First Quarter 2019 Financial Results:
As of March 31, 2019, Apellis had $288.2 million in cash and cash equivalents, compared to $176.3 million as of December 31, 2018. This includes $109.6 million in net proceeds raised in the public offering of common stock in March 2019 and a $60.0 million upfront payment received through the collaboration with SFJ Pharmaceuticals.
Apellis reported a net loss of $50.6 million for the first quarter of 2019, compared to a net loss of $21.7 million for the first quarter of 2018.
Research and development expenses were $40.5 million in the first quarter of 2019, compared to $17.4 million for the same period in 2018. The increase was primarily attributable to an increase of $9.7 million in clinical trial costs, an increase of $8.1 million in manufacturing expenses, an increase of $3.9 million in employee related costs primarily due to the hiring of additional personnel, an increase of $0.7 million related to research and development supporting activities, and an increase of $0.7 million in pre-clinical study expenses, partially offset by a decrease of $0.1 million in device development expenses.
General and administrative expenses were $8.1 million in the first quarter of 2019, compared to $4.0 million for the same period in 2018. The increase was primarily attributable to an increase in employee related costs of $2.8 million due to the hiring of additional personnel, an increase in professional and consulting fees of $0.9 million, an increase in general office costs of $0.3 million and an increase of $0.1 million in insurance costs.
APL-2, an investigational drug, is designed to inhibit the complement cascade centrally at C3 and may have the potential to treat a wide range of complement-mediated diseases more effectively than is possible with partial inhibitors of complement. APL-2 is a synthetic cyclic peptide conjugated to a polyethylene glycol (PEG) polymer that binds specifically to C3 and C3b, effectively blocking all three pathways of complement activation (classical, lectin, and alternative). Apellis is currently evaluating APL-2 in clinical studies in patients with geographic atrophy, in patients with PNH who are being treated with eculizumab or who are naïve to complement inhibitor treatment, in patients with autoimmune hemolytic anemia and in patients with C3G and other glomerular diseases.
About the DERBY and OAKS Trials
The DERBY and OAKS trials are 600-patient prospective, international, multicenter, randomized, double-masked, sham-injection controlled Phase 3 studies assessing the efficacy and safety of multiple intravitreal (IVT) injections of APL-2 in patients with geographic atrophy secondary to age-related macular degeneration (AMD). For more information, please visit https://gastudy.com/.
About APL-2 in Hematologic Diseases
Apellis is currently evaluating APL-2 in PEGASUS, a Phase 3 trial to evaluate the efficacy and safety of APL-2 in patients with PNH as well as in two Phase 1b trials (PHAROAH and PADDOCK) for systemic administration. Previously reported interim data from these Phase 1b trials showed improvements in lactate dehydrogenase and hemoglobin levels in patients who are suboptimal responders to eculizumab and untreated patients, respectively. Apellis is also testing APL-2 in a Phase 2 open-label trial assessing the safety, tolerability, efficacy, and PK of multiple subcutaneous (SC) doses of APL-2 administered daily in patients with warm autoimmune hemolytic anemia (wAIHA) or cold agglutinin disease (CAD). In this trial to date, patients treated with APL-2 have experienced improvements in hemoglobin, reticulocytes, bilirubin and lactate dehydrogenase. For additional information regarding our clinical trials, visit www.apellis.com/clinical-trials.html.
Apellis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds for the treatment of a broad range of life-threatening or debilitating autoimmune diseases based upon complement immunotherapy through the inhibition of the complement system at the level of C3. Apellis is the first company to advance chronic therapy with a C3 inhibitor into clinical trials. For additional information about Apellis and APL-2, please visit http://www.apellis.com.
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 FDA or equivalent foreign regulatory agencies for GA, PNH, CAD, wAIHA or any other indication; whether, if Apellis’ products receive approval, they will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of Apellis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2019 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.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|Three Months Ended March 31,|
|Research and development||$||17,402,890||$||40,479,899|
|General and administrative||4,035,255||8,170,671|
|Loss on extinguishment of debt||—||(1,208,132||)|
|Loss on remeasurement of development derivative liability||—||(736,000||)|
|Other income (expense), net||(31,473||)||(253,177||)|
|Other comprehensive income (loss):|
|Foreign currency gain||—||2,162|
|Total other comprehensive loss||—||2,162|
|Comprehensive loss, net of tax||$||(21,736,304||)||$||(50,572,205||)|
|Net loss per common share, basic and diluted||$||(0.43||)||$||(0.87||)|
|Weighted-average number of common shares used in net
loss per common share, basic and diluted
|APELLIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|December 31,||March 31,|
|Cash and cash equivalents||$||176,267,666||$||288,246,706|
|Refundable research and development credit||1,473,591||1,755,639|
|Other current assets||364,113||15,570|
|Total current assets||202,439,221||310,527,863|
|Property and equipment, net||977,918||1,041,063|
|Liabilities and Stockholders' Equity|
|Current portion of long-term debt||1,666,667||-|
|Current portion of right of use liabilities||—||1,127,720|
|Total current liabilities||17,024,607||20,386,473|
|Development derivative liability||—||60,736,000|
|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 March 31, 2019
|Common stock, $0.0001 par value; 200,000,000 shares authorized
at December 31, 2018 and March 31, 2019 and 56,279,307 shares
issued and outstanding at December 31, 2018 and 63,218,476 shares
issued and outstanding at March 31, 2019
|Additional paid in capital||437,855,681||552,209,429|
|Accumulated other comprehensive loss||(122,807||)||(120,645||)|
|Total stockholders' equity||160,972,655||224,754,892|
|Total liabilities and stockholders' equity||$||203,533,559||$||318,353,078|
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