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Aug 28

Ascendis Pharma A/S Reports Second Quarter 2020 Financial Results and Announces New Data from the Four-Week, Fixed Dose, Double-Blind Portion of the…

U.S. Biologics License Application for TransCon hGH submitted to U.S. Food and Drug Administration for pediatric growth hormone deficiency

Approval of Paediatric Investigation Plan by European Medicines Agency clears path for filing Marketing Authorisation Application for TransCon hGH in Europe in third quarter

New data from the four-week, fixed dose, double-blind portion of PaTH Forwarddemonstrated statistically significant and clinically meaningful improvementsin SF-36 functional health and well being outcomes

Conference call today at 4:30 p.m. Eastern Time

COPENHAGEN, Denmark, Aug. 27, 2020 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced new data from PaTH Forward and financial results for the quarter ended June 30, 2020.

We are executing across the globe on all elements of our Vision 3x3, including preparation for the expected U.S. launch for TransCon hGH following submission of our Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in June, and preparing to submit the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TransCon hGH in Europe planned for third quarter, said Jan Mikkelsen, Ascendis Pharmas President and Chief Executive Officer.

Mr. Mikkelsen continued, Additionally, with todays data release, we have, for the first time in a randomized, double-blind, placebo-controlled trial, demonstrated that a therapy for hypoparathyroidism (HP) may have a significant impact on improving quality of life for people living with HP compared to the standard of care. Our new data showed that TransCon PTH demonstrated a statistically significant1 and clinically meaningful impact on the SF-36 Health Survey (SF-36), a quality of life assessment tool validated to measure functional health and well being compared to placebo.2 Analysis of these exploratory endpoints, combined with expected findings from our proprietary patient reported outcome instrument, called Hypoparathyroidism Patient Experience Scale (HPES), will support the emerging body of evidence that TransCon PTH may function as a hormone replacement therapy and make a meaningful difference in improving the lives of people with HP.

Corporate Highlights & Progress

Second Quarter 2020 Financial Results

For the second quarter, Ascendis Pharma reported a net loss of 94.9 million, or 1.97 per share (basic and diluted) compared to a net loss of 58.9 million, or 1.25 per share (basic and diluted) for the same period in 2019.

Revenue for the second quarter was 1.4 million compared to 3.2 million in the same quarter of 2019. The decrease was due to a lower amount of license and service revenue being recognized from the companys strategic investment in VISEN Pharmaceuticals.

Research and development (R&D) costs for the second quarter were 63.6 million compared to 43.8 million during the same period in 2019. Higher R&D costs in 2020 reflect an increase in personnel-related costs, overhead costs allocated to R&D, and the continued progress in development of the companys product candidates.

Selling, general and administrative (SG&A) expenses for the second quarter were 20.8 million compared to 11.0 million during the same period in 2019. The increase is primarily due to additional personnel-related costs, higher IT and other site costs, and continued build out of the companys commercial capabilities.

As of June 30, 2020, Ascendis Pharma had cash, cash equivalents and marketable securities totaling 471.6 million compared to 534.4 million as of March 31, 2020. As of June 30, 2020, Ascendis Pharma had 48,345,782 ordinary shares outstanding.

Conference Call and Webcast information

Ascendis Pharma will host a conference call and webcast today at 4:30 p.m. Eastern Time (ET) to discuss its second quarter 2020 financial results. Details include:

A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at http://www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

About Ascendis Pharmas Pipeline

Ascendis Pharma currently has three product candidates in clinical development in rare endocrine diseases:

Additionally, the company has established oncology as its second therapeutic area of focus and plans to submit an IND or similar in the fourth quarter of 2020 for TransCon TLR7/8 Agonist, the companys first oncology product candidate.

AboutAscendis Pharma A/S

Ascendis Pharmais applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies.

Ascendis Pharmacurrently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and is advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs.

Ascendis is headquartered inCopenhagen, Denmark, with additional offices in Heidelberg andBerlin, Germany, and inPalo AltoandRedwood City, California.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis plans to submit its marketing application for TransCon hGH in in Europe in the third quarter of 2020, (ii) Ascendis plans to report six-month data from the open-label extension portion of the PaTH Forward Trial during the third quarter of 2020, (iii) Ascendis plans to submit regulatory filings to initiate a global phase 3 trial evaluating TransCon PTH in North America, Europe and Asia in the fourth quarter of 2020, (iv) Ascendis ability to apply its platform technology to build a leading, fully integrated biopharma company, (v) Ascendis product pipeline and expansion into additional therapeutic areas, and (vi) Ascendis expectations regarding its ability to utilize its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, selling, general and administrative expenses, other research and development expenses and Ascendis business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis ability to obtain additional funding, if needed, to support its business activities and the effects on its business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis business in general, see Ascendis prospectus supplement filed onJuly 9, 2020and Ascendis current and future reports filed with, or submitted to, theU.S. Securities and Exchange Commission(SEC), including its Annual Report on Form 20-F filed with theSEConApril 3, 2020. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

Ascendis,Ascendis Pharma, theAscendis Pharmalogo, the company logo and TransCon are registered trademarks owned by theAscendis Pharma Group. August 2020Ascendis Pharma A/S.

FINANCIAL TABLES FOLLOW

____________1 Data on file.2 Maruish, M. E. (Ed.). Users manual for the SF-36v2 Health Survey (3rd ed.). Lincoln, RI: QualityMetric Incorporated.3 Horton WA, et al.Lancet. 2007;370(9582):162172.4 D.B. Rosen, et al. Poster presented at the American Association of Cancer Research (AACR) 2020 Virtual Annual Meeting II, June 2224 (virtual).5 Pauli RM. J Rare Dis. 2019; 14:1

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Ascendis Pharma A/S Reports Second Quarter 2020 Financial Results and Announces New Data from the Four-Week, Fixed Dose, Double-Blind Portion of the...

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