SOUTH PLAINFIELD, N.J., Nov. 14, 2013 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT), a biopharmaceutical company focused on the discovery and development of orally administered, proprietary small molecule drugs that target post-transcriptional control processes, today announced financial and corporate results for the quarter ended September 30, 2013.
"2013 has thus far been an exciting year for us. PTC was founded based upon a strong scientific platform focused on RNA biology with the goal of bringing new therapies to patients with rare disorders and we have made tremendous progress this year towards realizing that goal," said Stuart Peltz, PhD, Chief Executive Officer, PTC Therapeutics, Inc. "We initiated our nonsense mutation Duchenne muscular dystrophy confirmatory Phase 3 clinical trial, which was informed by our previous clinical results that defined the natural history of ambulation in DMD patients as measured by the six-minute walk test. These natural history results have been corroborated by subsequent studies, giving us a high degree of confidence that our ongoing confirmatory study is both well designed and well powered to demonstrate the efficacy of ataluren. In addition, a development candidate was selected in our spinal muscular atrophy (SMA) program in collaboration with Roche and the SMA Foundation. This development candidate was originally developed using PTC's Alternative Splicing platform, which we are also deploying against other medically important targets."
"As we look ahead to 2014, we are well positioned to execute on our strategy. This includes completing enrollment in our nonsense mutation Duchenne muscular dystrophy confirmatory Phase 3 clinical trial and the initiation of our Phase 3 confirmatory trial in nonsense mutation cystic fibrosis. We also look forward to advancement of our other programs highlighted in our R&D day."
Third Quarter 2013 Financial Highlights:
Today's Conference Call and Webcast Reminder
The PTC management team will host a conference call to discuss the company's financial results and recent and upcoming developments today, Thursday, November 14, 2013, at 8:00 a.m. ET. The call can be accessed by dialing 877-303-9216 (domestic) or 973-935-8152 (international) five minutes prior to the start of the call and providing the passcode 24942756.
The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors Relations" section of the company's website at ir.ptcbio.com. A replay of the webcast will be archived on the PTC website for 30 days following the call.
About PTC Therapeutics, Inc.
PTC Therapeutics is biopharmaceutical company focused on the discovery and development of orally administered, proprietary small molecule drugs that target post-transcriptional control processes. Post-transcriptional control processes regulate the rate and timing of protein production and are essential to proper cellular function. PTC's internally discovered pipeline addresses multiple therapeutic areas, including rare disorders, oncology and infectious diseases. PTC has developed proprietary technologies that it applies in its drug discovery activities and form the basis for collaborations with leading biopharmaceutical companies. For more information on the company, please visit our website www.ptcbio.com
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for PTC, the development of and potential market for PTC's product candidates, our Phase 3 clinical trials for ataluren in nmDMD and nmCF, our collaboration in SMA with Roche and the SMA Foundation, our current and planned regulatory filings with EMA, our earlier stage programs, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan" "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from those expressed or implied by these forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and conduct of clinical trials, availability of data from clinical trials, expectations for regulatory approvals, our scientific approach and general development progress, the availability or commercial potential of our product candidates and other factors discussed in the "Risk Factors" in the most recent Quarterly Report, which is on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent PTC's views only as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, the Company specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing PTC's views as of any date subsequent to the date of this press release.
PTC Therapeutics, Inc.Statements of Operations(In thousands, except per share data)Three Months EndedNine Months EndedSeptember 30,September 30,2012201320122013Revenues: Collaboration revenue
$6,043$15,455$22,861$27,395 Grant revenue
1,1528344,4452,890Total revenues and non-cash cancellation revenue
7,19516,28927,30630,285Operating expenses: Research and development (1)
10,46613,88636,68939,855 General and administrative (1)
3,7846,67911,39117,735Total operating expenses
14,25020,56548,08057,590Loss from operations
(7,055)(4,276)(20,774)(27,305)Interest (expense) income, net
(247)27(1,007)(6,250)Loss on extinguishment of debt
—(130)—(130)Other income (expense), net
———(18,249)Gain on exchange of convertible preferred stock inconnection with recapitalization
——159,9543,391Less beneficial conversion charge
——(378)—Net (loss) income attributable to common stockholders
($7,297)($4,416)$139,613($48,546)Weighted-average shares outstanding (in shares):Basic
4,54523,803,28213,5938,995,167Net (loss) income per share applicable to common stockholders - basic (in dollars per share)
($1,605.53)($0.19)$182.41($5.40)Net (loss) income per share applicable to common stockholders - diluted (in dollars per share)
($1,605.53)($0.19)$39.41($5.40)(1) Non-cash share-based compensation expenseincluded in operating expenses are as follows:Research and development
$193$677$654$1,378General and administrative
3271,9631,1623,764Total share-based compensation expense
PTC Therapeutics, Inc.Summary Balance Sheet(In thousands, except share amounts)December 31, September 30,20122013Cash, cash equivalents and marketable securities
$2,726$157,227Total assets$13,072$167,244Total debt
4,88384Total deferred revenue
17,4323,631Total liabilities$31,889$16,212Total stockholders' (deficit) equity (4,526 and 23,803,282 common shares issued and outstanding at December 31, 2012 and September 30, 2013, respectively)
(99,641)151,032Total liabilities, convertible preferred stocks and stockholders' (deficit) equity$13,072$167,244
|SOURCE PTC Therapeutics, Inc.|
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