Apellis Pharmaceuticals Reports First Quarter 2018 Business Update and Financial Results
- APL-2 in Geographic Atrophy (GA) and Paroxysmal Nocturnal Hemoglobinuria (PNH) On Track to Advance into Phase 3 Trials in 2H18 -
- Cash Position of $152.9 Million at Quarter-End; April 2018 Public Offering Raised Additional $131.3 Million in Net Proceeds To Support Advancing APL-2 Into Phase 3 Programs in GA and PNH -
CRESTWOOD, Ky. and CAMBRIDGE, Mass., April 30, 2018 (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 2018 financial results and business highlights.
“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 Cedric Francois, MD, PhD, founder and chief executive officer of Apellis. “The 18-month FILLY trial results and interim data from the Phase 1b PADDOCK trial increase our confidence in the potential for APL-2 to treat a variety of complement-mediated conditions and we look forward to initiating Phase 3 trials in both GA and PNH in the second half of this year. The recently completed financing supports advancing APL-2 into both Phase 3 programs and provides the capital necessary to further advance our pipeline in multiple indications.”
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 February 2018.
- 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:
As of March 31, 2018, Apellis had $152.9 million in cash and cash equivalents, compared to $175.6 million as of December 31, 2017. In April 2018, the Company completed a public offering of 5.5 million shares of common stock at $25.50 per share, raising net proceeds of $131.3 million, after deducting underwriting discounts, commissions and offering expenses.
Apellis reported a net loss of $21.7 million for the first quarter of 2018, compared to a net loss of $9.1 million for the first quarter of 2017. The increase was primarily due to the expansion of operations and activities necessary to advance the Company’s two lead programs into Phase 3 trials during 2018.
Research and development expenses were $17.4 million in the first quarter of 2018, compared to $7.2 million for the same period in 2017. The increase was primarily due to increases of $4.4 million in clinical trial costs, $3.3 million in manufacturing expenses, $1.3 million in employee related costs primarily due to the hiring of additional personnel, $0.6 million in research and development supporting activities, $0.4 million in device development expenses and $0.2 million in pre-clinical study expenses.
General and administrative expenses were $4.0 million in the first quarter of 2018, compared to $1.8 million in the first quarter of 2017. The increase was primarily due to increases of $0.9 million in employee related costs, $0.4 million in director stock option compensation, $0.4 million in office, travel and related costs, $0.3 million in professional and consulting fees and $0.2 million in insurance costs.
About Apellis
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.
Forward-Looking Statements
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 | |||||||||
| (Unaudited) | |||||||||
| Three Months Ended | |||||||||
| March 31, | |||||||||
| 2017 | 2018 | ||||||||
| Operating expenses: | |||||||||
| Research and development | $ | 7,231,084 | $ | 17,402,890 | |||||
| General and administrative | 1,821,409 | 4,035,255 | |||||||
| Operating loss | (9,052,493 | ) | (21,438,145 | ) | |||||
| 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 | |||||||||
| (Unaudited) | |||||||||
| December 31, | March 31, | ||||||||
| 2017 | 2018 | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 175,643,529 | $ | 152,930,977 | |||||
| Refundable research and development credit | 1,297,361 | 1,828,565 | |||||||
| Prepaid assets | 5,059,593 | 8,121,602 | |||||||
| Other current assets | 14,823 | 205,713 | |||||||
| Total current assets | 182,015,306 | 163,086,857 | |||||||
| Other assets | 116,150 | 116,150 | |||||||
| Total assets | $ | 182,131,456 | $ | 163,203,007 | |||||
| Liabilities and Stockholders' Equity | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 3,663,253 | $ | 4,585,058 | |||||
| Accrued expenses | 2,890,705 | 2,709,801 | |||||||
| Total current liabilities | 6,553,958 | 7,294,859 | |||||||
| Long-term liabilities: | |||||||||
| 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 | |||||||
| Total liabilities | 33,188,596 | 34,160,902 | |||||||
| Stockholders' equity: | |||||||||
| 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 |
5,033 | 5,042 | |||||||
| Additional paid in capital | 298,201,480 | 300,037,020 | |||||||
| Accumulated deficit | (149,263,653 | ) | (170,999,957 | ) | |||||
| Total stockholders' equity | 148,942,860 | 129,042,105 | |||||||
| Total liabilities and stockholders' equity | $ | 182,131,456 | $ | 163,203,007 | |||||
CONTACT: Investor Contact: Alex Kane akane@w2ogroup.com 212.301.7218 (office) 929.400.2691 (mobile) Media Contact: Tully Nicholas tnicholas@denterlein.com 617.482.0042 (office) 860.490.0218 (mobile)