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A4250 Phase 3 trial in PFIC underway
A4250 granted rare pediatric disease designation, eligible to apply for priority review voucher
Management to host conference call and webcast today at 8:30 a.m. EDT
BOSTON, Aug. 07, 2018 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced financial results and corporate highlights for the second quarter ended June 30, 2018.
“The first half of 2018 was defined for Albireo by initiation of our Phase 3 program for A4250 in progressive familial intrahepatic cholestasis (PFIC),” said Ron Cooper, President and Chief Executive Officer of Albireo. “Notably, A4250 also received rare pediatric disease designation from the FDA, making Albireo eligible to apply for a priority review voucher upon submission of a new drug application for A4250. At the same time, we secured U.S. and E.U. method of use patents for elobixibat in the treatment of NASH, shared important findings on cholestatic liver disease at two scientific meetings, continued to strengthen our understanding of the cholestatic liver disease population and made key board and management appointments for our company.”
Advanced A4250 Program
Financial Update for the Three and Six-Month Periods Ended June 30, 2018
Three Months Ended June 30, 2018 vs. 2017
Six Months Ended June 30, 2018 vs. 2017
As previously announced, Albireo will host a conference call and webcast today, August 7, 2018, at 8:30 a.m. EDT. To access the live conference call by phone, dial 877-407-0792 (domestic) or 201-689-8263 (international) and provide the access code 13680985. A live audio webcast will be accessible from the Media & Investors page of Albireo’s website, http://ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Media & Investors page of Albireo’s website for at least two weeks following the event.
Albireo Pharma is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases, and other liver and gastrointestinal diseases and disorders. Albireo’s lead product candidate, A4250, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in its initial target indication, progressive familial intrahepatic cholestasis. Albireo’s clinical pipeline also includes two Phase 2 product candidates. Albireo’s elobixibat, approved in Japan for the treatment of chronic constipation, is the first ileal bile acid transporter (IBAT) inhibitor approved anywhere in the world. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, duration or results or timing for availability of results of, development of A4250 or any other Albireo product candidate or program, including regarding the Phase 3 clinical program for A4250 in patients with PFIC; the target indication(s) for development, the size, design, population, location, conduct, objective, duration or endpoints of any clinical trial, or the timing for initiation or completion of or reporting of results from any clinical trial, including the double-blind Phase 3 PFIC trial for A4250; the size of the PFIC population or any other disease population for indications that may be targeted by Albireo; the potential benefits or competitive position of A4250, elobixibat or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential benefits of a rare pediatric disease designation, the pricing of A4250 if approved; any future payment that HealthCare Royalty Partners or EA Pharma may make to Albireo or any other action or decision that EA Pharma may make concerning elobixibat or its business relationship with Albireo; the period for which Albireo’s cash resources will be sufficient to fund its operating requirements (runway); or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from the trials comprising the Phase 3 PFIC program or any other clinical trials of A4250; whether either or both of the FDA and EMA will determine that the primary endpoint for their respective evaluations and treatment duration of the double-blind Phase 3 trial in patients with PFIC are sufficient, even if the primary endpoint is met with statistical significance, to support approval of A4250 in the United States or the European Union, to treat PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or completion of, or for availability of data from, clinical trials of A4250, including the trials comprising the Phase 3 PFIC program, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or European Union; delays or other challenges in the recruitment of patients for, or the conduct of, the double-blind Phase 3 trial; the significant control that EA Pharma has over the commercialization of elobixibat in Japan; and Albireo’s critical accounting policies. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading “Risk Factors” in Albireo’s most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.
Albireo Pharma, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
|June 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||183,228||$||53,231|
|Prepaid expenses and other assets||610||1,054|
|Total current assets||186,244||55,011|
|Property and equipment, net||210||178|
|Other noncurrent assets||422||775|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||7,914||7,929|
|Liability related to sale of future royalties||46,736||—|
|Common stock, $0.01 par value per share — 30,000,000 authorized at June 30,
2018 and December 31, 2017; 11,957,491 and 8,902,784
issued and outstanding at June 30, 2018 and December 31, 2017, respectively
|Additional paid in capital||211,140||114,522|
|Accumulated other comprehensive income||4,768||1,001|
|Total stockholders’ equity||149,447||65,253|
|Total liabilities and stockholders’ equity||$||204,136||$||73,224|
See accompanying notes to Condensed Consolidated Financial Statements.
Albireo Pharma, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||6,411||2,962||12,562||5,774|
|General and administrative||4,238||3,713||8,366||6,925|
|Other (income) expense, net||(191||)||(65||)||1,313||9|
|Total operating expenses||10,458||6,610||22,241||12,708|
|Interest income (expense), net||(1,666||)||(152||)||(2,682||)||(401||)|
|Non-operating income (expense), net||(3,209||)||585||(3,231||)||260|
|Net loss before income taxes||(14,603||)||(6,176||)||(16,222||)||(12,847||)|
|Net loss per share - basic and diluted||$||(1.22||)||$||(0.86||)||$||(1.42||)||$||(1.91||)|
|Weighted average shares outstanding - basic and diluted||11,938,357||7,171,610||11,417,463||6,734,555|
LifeSci Advisors, LLC
Source: Albireo Pharma, Inc.