WALTHAM, Mass., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced its third quarter 2020 financial results and business highlights.

“This has been another remarkable quarter for Apellis, culminating in our new collaboration with Sobi for global co-development and ex-U.S. commercialization of systemic pegcetacoplan for up to $1.25 billion in payments plus tiered royalties ranging from high teens to high twenties,” said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis. “This collaboration allows us to more fully explore the pipeline-in-a-product opportunity of systemic pegcetacoplan while also putting us in a position of financial strength for the Phase 3 readout in geographic atrophy next year, a program for which we retain worldwide rights.

“During the quarter, we also announced new data in several diseases including geographic atrophy, C3G, and severe COVID-19, further reinforcing the broad platform potential of our targeted C3 approach. Our team remains focused on delivering groundbreaking therapies for patients with a wide range of serious diseases, beginning with a potential U.S. launch in PNH.”

Business Highlights and Upcoming Milestones:

Systemic Pegcetacoplan (APL-2)

Intravitreal Pegcetacoplan

COVID-19 Clinical Program

Third Quarter 2020 Financial Results:

As of September 30, 2020, Apellis had $728.2 million in cash, cash equivalents, and short-term marketable securities, compared to $352 million in cash and cash equivalents as of December 31, 2019. This does not include the $250 million upfront proceeds from the Sobi transaction that was announced on October 27, 2020.

Apellis reported a net loss of $135.7 million for the third quarter of 2020, compared to a net loss of $69.8 million for the third quarter of 2019.

Research and development expenses were $93.2 million in the third quarter of 2020, compared to $51.3 million for the same period in 2019. The increase was primarily attributable to an increase of $18.0 million in contract manufacturing expenses in connection with the supply of pegcetacoplan for our Phase 3 clinical trials, an increase of $6.7 million in clinical trial costs associated with the continued enrollment of our Phase 3 clinical trials in PNH and GA, an increase of $9.9 million in personnel-related costs primarily due to the hiring of additional personnel, an increase of $7.8 million related to research and innovation activities and other development costs and offset by a decrease of $0.5 million in pre-clinical study expenses and device development expenses. We would expect our research and development expenses to continue to increase with the number of aggregate patients enrolled in our trials and as we may add to the number of ongoing trials for systemic pegcetacoplan.

General and administrative expenses were $37.0 million in the third quarter of 2020, compared to $18.6 million for the same period in 2019. The increase was primarily attributable to an increase in employee-related costs of $8.2 million, an increase in professional and consulting fees and general commercial preparation activities of $9.7 million, an increase of $0.4 million in director stock compensation expense, and an increase in $0.3 million in insurance, offset by a decrease in general office costs and conference and travel-related expenses of $0.2 million. The increase in employee-related costs of $8.2 million consisted of a $5.7 million increase in salaries and benefits primarily due to the increase in the number of employees, $3.5 million related to stock expense associated with the grant of stock options and restricted stock units to employees offset by a decrease of $1.0 million in recruitment expense. The increase in other professional and consulting fees and general commercial preparation activities of $9.7 million primarily related to an increase in commercial-related activity of $6.3 million, a $2.6 million increase in legal and accounting fees, and an increase in general professional fees of $0.7 million and an increase in communication and public relations fees of $0.1 million.

About Pegcetacoplan (APL-2)
Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan is a synthetic cyclic peptide conjugated to a polyethylene glycol polymer that binds specifically to C3 and C3b. Apellis is evaluating pegcetacoplan in several clinical studies across hematology, ophthalmology, nephrology, and neurology. Pegcetacoplan was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and the treatment of geographic atrophy, and received orphan drug designation for the treatment of C3 glomerulopathy (C3G) by the FDA and European Medicines Agency. For additional information regarding our clinical trials, visit https://apellis.com/our-science/clinical-trials.

About APL-9
APL-9 is an investigational, targeted C3 therapy designed to control the complement cascade centrally and may have the potential to treat a range of diseases caused by excessive activation of complement. APL-9 leverages the same mechanism of action as Apellis’ lead compound, pegcetacoplan, but has a lower molecular weight and shorter half-life. APL-9 is designed to be intravenously administered for acute use.

About Apellis
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies. Leaders in targeted C3 therapies, we aim to develop transformative therapies for a broad range of debilitating diseases that are driven by excessive activation of the complement cascade, including those within hematology, ophthalmology, nephrology, and neurology. For more information, please visit http://apellis.com.

Apellis Forward-Looking Statement
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 pegcetacoplan will successfully advance through the clinical trial process on a timely basis, or at all; whether the results of the company’s clinical trials will warrant regulatory submissions and whether pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for GA, PNH, CAD, C3G, IC-MPGN, ALS or any other indication when expected or at all; 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 November 2, 2020 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.

Investor Contact:
Sam Martin / Maghan Meyers
Argot Partners
sam@argotpartners.com / maghan@argotpartners.com
212.600.1902

Media Contact:
Tracy Vineis
media@apellis.com
617.420.4839




APELLIS PHARMACEUTICALS, INC.   
CONDENSED CONSOLIDATED BALANCE SHEETS
 
(Amounts in thousands, except per share amounts)   
  September 30, December 31, 
   2020   2019  
Assets (Unaudited)   
Current assets:     
Cash and cash equivalents $415,560  $351,985  
Marketable Securities  312,598   -  
Prepaid assets  11,299   19,802  
Restricted Cash  1,255   -  
Other current assets  1,637   1,308  
Total current assets  742,349   373,095  
Non-current Assets:     
Right-of-use assets  18,545   14,110  
Property and equipment, net  6,531   1,655  
Other assets  909   385  
Total assets $768,334  $389,245  
Liabilities and Stockholders' Equity     
Current liabilities:     
Accounts payable $11,069  $8,361  
Accrued expenses  60,766   54,783  
Current portion of right of use liabilities  3,438   2,609  
Total current liabilities  75,273   65,753  
Long-term liabilities:     
Convertible senior notes  353,769   142,567  
Development derivative liability  217,778   134,839  
Operating lease liabilities  15,674   11,857  
Total liabilities  662,494   355,016  
Stockholders' equity:     
Preferred stock, $0.0001 par value; 10.0 million shares authorized, and zero shares issued and outstanding at September 30, 2020 and December 31, 2019  -   -  
Common stock, $0.0001 par value; 200.0 million shares authorized at September 30, 2020 and December 31, 2019; 75.7 million shares issued and outstanding at June 30, 2020, and 63.9 million shares issued and outstanding at December 31, 2019  8   6  
Additional paid in capital  1,112,203   615,850  
Accumulated other comprehensive loss  (1,759)  (154) 
Accumulated deficit  (1,004,612)  (581,473) 
Total stockholders' equity  105,840   34,229  
Total liabilities and stockholders' equity $768,334  $389,245  
      



APELLIS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
        
 For the Three Months Ended September 30, For the Nine Months Ended September 30,
  2020   2019   2020   2019 
 (Unaudited)
Revenue:       
Licensing revenue$646  $—  $646  $— 
Total revenue 646   —   646   — 
Operating expenses:       
Research and development 93,207   51,319   249,584   142,497 
General and administrative 36,991   18,629   94,909   39,578 
Total operating expenses: 130,198   69,948   344,493   182,075 
Net operating loss (129,552)  (69,948)  (343,847)  (182,075)
Loss on extinguishment of debt —   (293)  —   (1,501)
Gain/(loss) from remeasurement of development derivative liability 2,697   (263)  (62,939)  (10,103)
Interest income 670   1,342   3,970   3,630 
Interest expense (9,499)  (602)  (20,327)  (1,354)
Other income/(expense), net (16)  (61)  4   (86)
Net loss (135,700)  (69,825)  (423,139)  (191,489)
Other comprehensive loss:       
    Unrealized gain/(loss) on marketable securities (430)  —   122   — 
    Foreign currency loss (1,658)  (83)  (1,727)  (83)
Total other comprehensive loss (2,088)  (83)  (1,605)  (83)
Comprehensive loss, net of tax$(137,788) $(69,908) $(424,744) $(191,572)
Net loss per common share, basic and diluted$(1.79) $(1.10) $(5.65) $(2.79)
Weighted-average number of common shares used in net loss per common share, basic and diluted 75,628   63,753   74,925   68,737