– Luspatercept phase 2 data showed encouraging
activity in lower risk myelodysplastic syndromes (MDS) patients
–
– Celgene and Acceleron selected luspatercept
to advance into Phase 3 programs in MDS and beta-thalassemia by
year-end –
– Promising data from dalantercept phase 2
clinical trial in patients with renal cell carcinoma presented at
ASCO-GU conference –
Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel therapeutic candidates that regulate
cellular growth and repair, today provided a corporate update and
reported financial results for the first quarter ended
March 31, 2015.
“Acceleron’s clinical pipeline of proprietary compounds
continues to generate encouraging data across several disease
indications,” said John Knopf, Ph.D., Chief Executive Officer of
Acceleron. “Furthermore, we are making great operational progress
advancing our pipeline, including plans to initiate phase 3
programs with luspatercept in both MDS and beta-thalassemia by
year-end with our collaboration partner Celgene.”
Recent Highlights and Current Updates
Clinical Development Programs
- Luspatercept selected to advance to
phase 3 program in myelodysplastic syndromes (MDS) and
beta-thalassemia by year-end
- Presented preliminary MDS phase 2
data showing that luspatercept increased hemoglobin levels and
enabled transfused patients to become transfusion independent -
Lower risk MDS patients that were either non-responsive, refractory
or deemed ineligible to receive erythropoiesis stimulating agents,
were treated with luspatercept for three months. 54% of patients in
the higher dose groups achieved the International Working Group
hematologic improvement-erythroid response. Furthermore, 36% of
patients who received red blood cell transfusions during the 8
weeks prior to treatment in the study achieved transfusion
independence for at least 8 weeks during the study.
- Presented preliminary renal cell
carcinoma (RCC) phase 2 data showing that the combination of
dalantercept and axitinib generated encouraging progression-free
survival - In 2nd through 4th line RCC patients, the
combination of dalantercept and axitinib generated a median
progression-free survival rate of 8.3 months in the ongoing phase 2
clinical trial.
- Advanced and expanded pipeline -
Made solid progress across the pipeline including therapeutic
candidates luspatercept, sotatercept, dalantercept and ACE-083.
Advanced several preclinical programs as pipeline continues to
expand with promising new programs.
Upcoming Milestones
- Presentations of new preliminary
phase 2 data from the luspatercept program in MDS and
beta-thalassemia patients at the 19th Congress of the
European Hematology Association (EHA) - New data from the
luspatercept phase 2 studies will be presented at the EHA annual
meeting in June in Vienna, Austria.
- Presentation of phase 2 data for
dalantercept in renal cell carcinoma at the American Society of
Clinical Oncology (ASCO) - Acceleron’s clinical investigators
will present data from the dose escalation and expansion stage of
the clinical trial at ASCO's annual meeting in June in
Chicago.
- Presentation of phase 2 data for
sotatercept in chronic kidney disease at the European Renal
Association - European Dialysis and Transplantation Association
(ERA-EDTA) - Acceleron’s collaboration partner Celgene and its
clinical investigators will present data at the ERA-EDTA meeting in
May in London, U.K.
- Data from new muscle program
expected to be presented at the World Muscle Society - We plan
to present data from a new preclinical program at the World Muscle
Society's 20th International Congress in Brighton, UK.
Other Business Highlights
- Francois Nader, M.D. appointed Chair
of the Acceleron Board of Directors
- Steven Ertel promoted to Executive
Vice President and Chief Operating Officer
- Matthew Sherman, M.D. promoted to
Executive Vice President and Chief Medical Officer
Financial Results
- Cash Position – Cash, cash
equivalents and investments as of March 31, 2015 were $165.0
million. As of December 31, 2014 the company had cash and cash
equivalents of $176.5 million. Acceleron expects that its
cash, cash equivalents and investments as of March 31, 2015
will be sufficient to fund the Company’s operations into the second
half of 2017.
Conference Call and Webcast
The company will host a conference call and live audio webcast
to report its first quarter financial results for 2015 and provide
a corporate update on May 7, 2015, at 8:00 AM EDT. To
participate by teleconference, please dial 877-312-5848 (domestic)
or 253-237-1155 (international) and refer to the “Acceleron Q1
Earnings Call.” To access the live webcast, please select “Events
& Presentations” in the Investors & Media section on the
Company’s website (www.acceleronpharma.com) at least 10 minutes
beforehand to ensure time for any downloads that may be
required.
An archived webcast recording will be available on the Acceleron
website beginning approximately two hours after the event.
About Acceleron
Acceleron is a clinical stage biopharmaceutical company focused
on the discovery, development and commercialization of novel
therapeutic candidates that regulate cellular growth and repair.
The company is a leader in understanding the biology of the
Transforming Growth Factor-Beta (TGF-beta) protein superfamily, a
large and diverse group of molecules that are key regulators in the
growth and repair of tissues throughout the human body, and in
targeting these pathways to develop important new medicines.
Acceleron has built a highly productive R&D platform that has
generated innovative clinical and preclinical therapeutic
candidates with novel mechanisms of action. These therapeutic
candidates have the potential to significantly improve clinical
outcomes for patients with cancer and rare diseases.
We routinely post information that may be important to investors
in the “Investors and Media” section of our website at www.acceleronpharma.com. We encourage investors
and potential investors to regularly consult our website for
important information about us.
ACCELERON PHARMA INC.CONDENSED
CONSOLIDATED BALANCE SHEET(Amounts in
thousands)(unaudited)
March 31, 2015
December 31, 2014
Cash, cash equivalents and investments $ 165,028 $ 176,460 Other
assets 10,545 9,836 Total assets $ 175,573 $ 186,296
Accrued expenses 8,259 7,572 Deferred revenue 5,606 5,978
Warrants to purchase common stock 13,702 14,124 Other liabilities
2,212 2,337 Total liabilities 29,779 30,011 Total
stockholders’ equity 145,794 156,285 Total liabilities and
stockholders’ equity $ 175,573 $ 186,296
ACCELERON PHARMA INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS(Amounts in thousands
except per share data)(unaudited)
Three Months Ended March 31,
2015 2014 Revenue: Collaboration revenue 4,420
3,307 Costs and expenses: Research and development 14,779 11,765
General and administrative 4,700 3,750 Total costs
and expenses 19,479 15,515 Loss from operations (15,059 ) (12,208 )
Total other income, net 485 3,088 Net loss applicable
to common stockholders $ (14,574 ) $ (9,120 ) Net loss per
share applicable to common stockholders-basic and diluted $ (0.45 )
$ (0.30 )
Weighted-average number of common shares
used in computing net loss per shareapplicable to common
stockholders-basic and diluted
32,633 30,321
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements about the
Company’s strategy, future plans and prospects, including
statements regarding the development of the Company’s compounds,
including sotatercept, luspatercept, dalantercept, or ACE-083 and
the Company’s TGF-beta superfamily program generally, the timeline
for clinical development and regulatory approval of the Company’s
compounds, the expected timing for the reporting of data from
ongoing trials, and the structure of the Company’s planned or
pending clinical trials. The words “anticipate,” “appear,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions are intended
to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Each
forward-looking statement is subject to risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied in such statement. Applicable risks and
uncertainties include the risks that the Company’s cash position
will be insufficient to fund operations into the second half of
2017, that preclinical testing of the Company’s compounds and data
from clinical trials may not be predictive of the results or
success of ongoing or later clinical trials, that data may not be
available when we expect it to be, that the Company or its
collaboration partner, Celgene, will be unable to successfully
complete the clinical development of its compounds, that the
development of the Company’s compounds will take longer or cost
more than planned, that the Company or Celgene may be delayed in
initiating or completing any clinical trials, and that the
Company’s compounds will not receive regulatory approval or become
commercially successful products. Other risks and uncertainties
include those identified under the heading “Risk Factors” included
in the Company’s Annual Report on Form 10-K which was filed with
the Securities and Exchange Commission (SEC) on March 2, 2015, and
other filings that the Company has made and may make with the SEC
in the future. The forward-looking statements contained in this
press release reflect the Company’s current views with respect to
future events, and the Company does not undertake and specifically
disclaims any obligation to update any forward-looking
statements.
Acceleron Pharma Inc.Kevin F. McLaughlin, 617-649-9204Senior
Vice President and Chief Financial OfficerorMedia:Suda
Communications LLCMaureen L. Suda, 585-387-9248
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