Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel protein therapeutics for cancer and rare
diseases, today provided a corporate update and reported financial
results for the third quarter ended September 30, 2013.
“The third quarter was transformative for Acceleron as we
completed a successful IPO, raised net proceeds of approximately
$97 million and advanced our business on all fronts,” said John
Knopf, Ph.D., Chief Executive Officer of Acceleron. “We’ve made
great progress with all three of our clinical programs –
sotatercept, ACE-536 and dalantercept – each of which is being
studied in multiple phase 2 clinical trials. Also, we continue to
advance several exciting preclinical programs, with the goal of
bringing an additional product into the clinic in 2014. We have
generated significant momentum across the entire pipeline and
expect to present interim clinical data and provide updates on our
clinical programs during each of the next several quarters.”
Business Highlights
- Completion of Initial Public
Offering – Acceleron announced on September 24, 2013, that it
had completed its initial public offering of common stock, which
yielded gross proceeds of $106.3 million and aggregate net proceeds
to the Company, after underwriting discounts and commissions and
other estimated offering expenses of approximately $96.8 million.
The net proceeds include a $10 million side-by-side private
placement of common stock to Celgene Corporation.
- Continued progress with sotatercept
and ACE-536 phase 2 trials for rare anemias – Acceleron and its
collaboration partner, Celgene, continue to enroll patients in the
dose escalation stages of the four ongoing phase 2 clinical trials
of sotatercept and ACE-536 in patients with β-thalassemia and
myelodysplastic syndromes (MDS).
- Completed enrollment of the dose
escalation stage for the dalantercept phase 2 clinical trial in
patients with renal cell carcinoma (RCC) – Acceleron has
completed enrollment in the dose escalation stage of the phase 2
clinical trial of dalantercept plus axitinib in renal cell
carcinoma patients who have failed at least one prior treatment
with a VEGF receptor tyrosine kinase inhibitor.
- Presentations – Acceleron’s
Chief Scientific Officer, Ravi Kumar, Ph.D., gave an oral
presentation of preclinical data with ACE-536 in a mouse model of
β-thalassemia at the Thalassaemia International Federation’s World
Congress 2013. β-thalassemia is characterized by the formation of
globin aggregates within red blood cell precursors in the bone
marrow that prevents these cells from maturing into functional red
blood cells. Data from a mouse model of β-thalassemia showed that
treatment with ACE-536 decreased these globin aggregates allowing
these precursors cells to mature into functional red blood cells
and alleviate the severe anemia and other serious comorbidities
associated with this disease.
Financial Results
- Cash Position – Cash and cash
equivalents as of September 30, 2013 were $116.5 million,
compared to $39.6 million at December 31, 2012. The cash
increase was primarily driven by total net proceeds of $96.8
million from Acceleron’s initial public offering and the
side-by-side private placement of common stock to Celgene.
Acceleron expects that its cash and cash equivalents will fund the
Company into the second half of 2015.
- Revenue - Collaboration revenue
was $4.3 million for the third quarter of 2013 and $45.7 million
for the nine months ended September 30, 2013, compared to $3.9
million and $11.3 million for the comparable periods in 2012. The
increase in 2013 year to date collaboration revenue compared to
2012 was primarily driven by recognition of deferred revenue in the
second quarter of 2013 associated with termination of the Shire
collaboration.
- R&D Expenses – Research and
development expenses were $8.1 million for the third quarter of
2013 and $25.8 million for the nine months ended September 30,
2013, compared to $8.7 million and $25.6 million for the comparable
periods in 2012.
- G&A Expenses – General and
administrative expenses were $3.0 million for the third quarter of
2013 and $9.5 million for the nine months ended September 30, 2013,
compared to $2.0 million and $6.3 million for the comparable
periods in 2012. The increase was largely driven by higher
corporate legal fees as well as incremental expenses to support
public company operations.
- Net Income (Loss) – Our net loss
was $18.5 million for the third quarter of 2013 and $3.8 million
for the nine months ended September 30, 2013, compared to a net
loss of $7.2 million and $22.2 million for the comparable periods
in 2012. The third quarter and year-to-date results were affected
by the expenses associated with marking to market outstanding
warrants to purchase of common stock. The expenses associated with
the increase in common warrant valuation of $10.1 million and $11.3
million for the three months and nine months ending September 30,
2013, respectively, were due to a higher September 30, 2013 closing
stock price compared to the value of the Company’s stock in earlier
periods.
Upcoming Milestones
- Sotatercept interim data from the
β-thalassemia phase 2 clinical trial to be presented at the 2013
American Society of Hematology Annual Meeting – Acceleron’s
collaboration partner, Celgene, will provide a poster presentation
with interim data from the dose escalation stage of the ongoing
phase 2 clinical trial in patients with β-thalassemia at the 2013
American Society of Hematology Annual Meeting on Monday, December
9th in New Orleans.
- Plans to report interim data from
the dose escalation stages of the sotatercept and ACE-536 clinical
trials in β-thalassemia and MDS – Acceleron expects to announce
these interim data during the second quarter of 2014.
- Initiating sotatercept phase 2 trial
in patients with chronic kidney disease – Acceleron expects
Celgene to initiate a phase 2 clinical trial of sotatercept in
patients with end stage renal disease on hemodialysis who are
anemic and suffer from chronic kidney disease mineral and bone
disorder in the fourth quarter of 2013 or early in the first
quarter of 2014.
- Expanding phase 2 program for
dalantercept in renal cell cancer – Acceleron plans to begin
enrolling patients in the expansion stage of the ongoing phase 2
clinical trial of dalantercept in renal cell cancer during the
fourth quarter of 2013 and to report data from the dose escalation
stage in the first quarter of 2014. Additionally, the Company
expects to begin the randomized, blinded, placebo-controlled stage
of this trial comparing the combination of dalantercept plus
axitinib to axitinib plus placebo by the end of the first quarter
of 2014.
- Advancing new clinical development
candidate – Acceleron is conducting preclinical activities in
preparation for the submission of an Investigational New Drug (IND)
application for its clinical candidate ACE-083, a locally acting
drug designed to increase muscle mass and strength. The Company
plans to submit the IND for ACE-083 in 2014.
Conference Call and Webcast Information
The company will host a conference call and live audio webcast
to report its third quarter financial results and provide a
corporate update on November 6, 2013, at 9:00 AM EST. To
participate by teleconference, please dial (877) 312-5848
(domestic) or (253) 237-1155 (international) and refer to the
“Acceleron Q3 Earnings Call.” To access the live webcast, please
select “Events & Presentations” in the Investors & Media
section on the Company’s website (www.acceleronpharma.com). To
ensure a timely connection, it is recommended that users register
at least 15 minutes prior to the scheduled webcast.
A replay of the webcast will be archived on the Company’s
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
protein therapeutics for cancer and rare diseases. The company is a
leader in understanding the biology of the Transforming Growth
Factor-Beta (TGF-β) 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 protein therapeutic candidates with novel
mechanisms of action. These protein therapeutic candidates have the
potential to significantly improve clinical outcomes for patients
with cancer and rare diseases.
For more information, please visit www.acceleronpharma.com.
ACCELERON PHARMA INC.
CONDENSED BALANCE SHEET
(UNAUDITED)
(Amounts in thousands)
September
30,2013 December 31,2012 Cash and
cash equivalents $ 116,479 $ 39,611 Other assets 10,781 9,601 Total
assets $ 127,260 $ 49,212 Deferred revenue $ 8,556 $ 34,600
Notes payable, net of discount 18,635 20,193 Warrants to purchase
common stock 16,526 5,229 Other liabilities 8,979 11,553 Total
liabilities 52,696 71,575 Redeemable convertible preferred stock —
268,610 Stockholders’ equity (deficit) 74,564 (290,973 ) Total
liabilities, redeemable convertible preferred stock and
Stockholders’ equity (deficit) $ 127,260 $ 49,212
ACCELERON PHARMA INC.
CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
(Amounts in thousands except per share
data)
Three Months Ended
September 30, Nine Months Ended September 30,
2013 2012 2013 2012
Collaboration revenue $ 4,270 $ 3,905 $ 45,710 $ 11,269
Costs and expenses: Research and development 8,143 8,722
25,834 25,646 General and administrative 3,011 2,041
9,472 6,318 Total costs and expenses 11,154
10,763 35,306 31,964 (Loss) income from operations (6,884 )
(6,858 ) 10,404 (20,695 ) Other expense, net (11,629
) (357 ) (14,192 ) (1,508 ) Net loss $
(18,513 ) $ (7,215 ) $ (3,788 ) $ (22,203 )
Accretion of dividends, interest,
redemption
value and issuance costs on redeemable
convertible preferred stock
(6,272 ) (6,747 ) (19,870 ) (20,293 )
Gain on extinguishment of redeemable
convertible preferred stock
— — 2,765 —
Net loss applicable to common stockholders
–
basic and diluted
$ (24,785 ) $ (13,962 ) $ (20,893 ) $ (42,496 ) Net
loss per share applicable to common stockholders: Basic $ (5.62 ) $
(5.82 ) $ (6.74 ) $ (17.73 ) Diluted $ (5.62 ) $ (5.82 ) $ (6.74 )
$ (17.73 )
Weighted average number of common
shares
used in computing net loss per share
applicable to common stockholders:
Basic 4,406 2,400 3,100 2,397 Diluted 4,406 2,400 3,100 2,397
Note: Common shares outstanding as of the end of the third
quarter of 2013 were 28.1 million following the sale of
6.4 million shares of common stock, including all additional
shares sold to cover over-allotments, in the Company’s initial
public offering, 0.7 million shares of common stock to Celgene in a
private placement and the resulting automatic conversion of the
Company’s redeemable convertible preferred stock into
18.5 million shares of common stock, compared to
2.5 million common shares as of the end of the third quarter
of 2012. The Company’s weighted average shares outstanding for the
third quarter of 2013 were 4.4 million shares.
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, ACE-536, dalantercept, or ACE-083 and the
Company’s TGF-β 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 preclinical testing of the
Company’s compounds and preliminary 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, 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 Registration Statement on Form S-1 which was
declared effective by the Securities and Exchange Commission (SEC)
on September 18, 2013, and other filings that the Company 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.
Media:Acceleron PharmaKevin F. McLaughlin, 617-649-9204Senior
Vice President and Chief Financial OfficerorSuda Communications
LLCMaureen L. Suda, 585-387-9248
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