On August 28, 2019 LIDDS AB reported that Professor Laurence Klotz, a world leading expert in Active Surveillance of prostate cancer patients, reported that it will present the results of the LPC-004 prostate cancer study at the 11th European Multidisciplinary Congress on Urological Cancers, EMUC19 (Press release, Lidds, AUG 28, 2019, View Source [SID1234555905]). The oral presentation is scheduled for November 16, 2019.

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Professor Klotz is one of the LPC-004 study investigators and is Professor at the University of Toronto Division of Urology at the Sunnybrook Health Sciences Centre in Canada.

-I am very pleased that the Phase IIb study results will be presented at EMUC by the expert and key opinion leader Professor Klotz, says Monica Wallter, CEO, LIDDS.

LIDDS will announce the preliminary results of the LPC-004 study in September. The final study report is scheduled for the last quarter of 2019.

On August 28, 2019 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported financial results for the quarter ended June 30, 2019 (Press release, Ascendis Pharma, AUG 28, 2019, View Source [SID1234551448]).

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"The achievements across our three rare disease endocrinology product candidates during the first half of 2019 show we are on track to fulfill our ’Vision 3×3’ to become a leading biopharma company," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "Based on the integrated, holistic view of our data, we expect TransCon hGH to raise the bar in the treatment of growth hormone deficiency, and we are getting even more confident that we will also set a new standard with TransCon PTH and TransCon CNP."

Corporate Highlights & Progress

On track for a planned Biologics License Application (BLA) in the first half of 2020 and a marketing application (MAA) in Europe in the second half of 2020 for TransCon hGH, a long-acting prodrug of human growth hormone (hGH) in development as a once-weekly therapy for pediatric growth hormone deficiency (GHD). Results from the phase 3 program demonstrated statistically significantly greater efficacy (heiGHt Trial) and comparable safety and tolerability to a daily hGH (heiGHt Trial and fliGHt Trial). Additionally, Ascendis is working in collaboration with VISEN Pharmaceuticals to initiate a phase 3 trial later this year in subjects with pediatric GHD in China, and plans to initiate a global program for adult GHD in 2020.
Introduced the TransCon hGH Auto-Injector and dual-chamber cartridge (DCC) combination product as planned into the enliGHten Trial, a long-term extension trial for TransCon hGH. Data from the enliGHten Trial, including long-term safety data, will support the planned BLA and planned MAA for TransCon hGH.
Ongoing enrollment in the PaTH Forward Trial, a global, phase 2 trial designed to evaluate the safety and efficacy of TransCon PTH in adult subjects with hypoparathyroidism. TransCon PTH is a long-acting prodrug of parathyroid hormone (PTH) in development for the treatment of adult hypoparathyroidism. TransCon PTH has been designed to provide physiologic levels of PTH for 24 hours a day, seven days a week.
Completed filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of the ACcomplisH Trial, a global, phase 2, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of TransCon CNP at escalating doses in children with achondroplasia (ACH). TransCon CNP is a long-acting prodrug of C-type natriuretic peptide (CNP) that has been designed to provide continuous exposure to CNP at therapeutic levels with once-weekly dosing. All subjects who complete the ACcomplisH Trial will have the opportunity to receive TransCon CNP in a long-term safety extension trial.
Introduced the company’s oncology vision and programs.
Ended the second quarter of 2019 with cash and cash equivalents of €690.4 million.
Second Quarter 2019 Financial Results

For the second quarter, Ascendis Pharma reported a net loss of €58.9 million, or €1.25 per share (basic and diluted) compared to a net loss of €22.8 million, or €0.55 per share (basic and diluted) for the same period in 2018.

Revenue for the second quarter was €3.2 million compared to €18 thousand in the same quarter of 2018. The increase reflects recognition of revenue related to our strategic investment in VISEN Pharmaceuticals.

Research and development (R&D) costs for the second quarter were €43.8 million compared to €40.2 million during the same period in 2018. Higher R&D costs in 2019 primarily reflect an increase in personnel-related costs to support development and manufacturing of TransCon hGH, TransCon PTH and TransCon CNP, as well as increased costs for other research programs, partly offset by a decrease in costs associated with TransCon hGH due to completion of the phase 3 heiGHt Trial.

General and administrative expenses for the second quarter were €11.0 million compared to €5.2 million during the same period in 2018. The increase is primarily due to higher personnel-related costs and other increasing costs of preparing to become a commercial organization.

As of June 30, 2019, Ascendis had cash and cash equivalents of €690.4 million compared to €696.7 million as of March 31, 2019. As of June 30, 2019, Ascendis Pharma had 47,545,204 ordinary shares outstanding.

Conference Call and Webcast information

Ascendis Pharma will host a conference call and webcast today at 4:30 p.m. ET to discuss its second quarter 2019 financial results. Details include:

Date Wednesday, August 28, 2019
Time 4:30 p.m. ET
Dial In (U.S.) 844-290-3904
Dial In (International) 574-990-1036
Access Code 4793306
A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

On August 28, 2019 iCo Therapeutics (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or the "Company"), reported financial results for the Quarter ended June 30, 2019 (Press release, iCo Therapeutics, AUG 28, 2019, View Source [SID1234551419]). Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS").

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Stated Andrew Rae, President and CEO of iCo Therapeutics Inc.,"Q2 efforts were significant in laying a foundation for the corporate milestones we expect in late 2019 and early 2020."

Q2 2019 Financial and Operational Highlights

During the quarter, the Company continued to participate in Immune Pharmaceutical’s bankruptcy proceedings ensuring iCo’s interests with respect to iCo-008 were presented to the Court.

Following feedback from an Australian IRB, requiring iCo to conduct a multi-dose escalation analysis in a number of healthy subjects prior to diseased subjects, iCo is currently working to revise its ethics application. iCo currently expects to commence recruitment of subjects in early Q4 2019 and will provide further details on study design upon ethics approval.

Subsequent to Q2, on August 16, 2019, the Company closed a non-brokered financing issuing 41,200,000 units at $0.05 per unit for aggregate gross proceeds of $2,060,000.

Financial results for Quarter ended June 30, 2019

We incurred a total comprehensive loss of $386,359 for the quarter ended June 30, 2019 compared to a total comprehensive loss of $620,227 for the quarter ended June 30, 2018, representing a decreased loss of $233,868. The decrease in the loss is primarily the result of lower research and development expenses recognized during 2019 offset by higher general and administrative expenses and lower other income.

Research and development expenses were $156,333 for the quarter ended June 30, 2019 compared to $671,359 for the quarter ended June 30, 2018, representing a decrease of $515,025. The decrease related to lower contract research expenses related to the Oral Amp B Phase 1 clinical study. This study was completed in 2018.

For the quarter ended June 30, 2019 general and administrative expenses were $241,512 compared to $200,966 for the quarter ended June 30, 2018, representing an increase of $40,546. The increase reflects increased professional fees during the quarter.

Liquidity and Outstanding Share Capital

As at June 30, 2019, we had cash and cash equivalents of $114,162 compared to $10,140 as at December 31, 2018. As at August 28, 2019, we had an unlimited number of authorized common shares with 150,657,713 common shares issued and outstanding.

On august 28, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that management will participate in the following investor conferences in September (Press release, Autolus, AUG 28, 2019, View Source [SID1234550687]):

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Dr. Christian Itin, chairman and chief executive officer, will present at the Wells Fargo 2019 Healthcare Conference in Boston on Wednesday, September 4 at 3:00 p.m. ET and will host one-on-one meetings with attendees. A live webcast of the presentation will be available on the investor relations section of Autolus’ website at View Source An archived replay will be available on the company’s website for a period of 90 days after the conference.
Dr. Itin will participate in a fireside chat at the Morgan Stanley 17th Annual Global Healthcare Conference in New York on Monday, September 9 at 9:20 a.m. ET and will host one-on-one meetings with attendees. A live audio webcast of the fireside chat will be available on the investor relations section of Autolus’ website at View Source An archived replay will be available on the company’s website for a period of 90 days after the conference.
Andrew Oakley, chief financial officer, will present at the H.C. Wainwright 21st Annual Global Investment Conference in New York on Tuesday, September 10 at 2:10 p.m. ET and will host one-on-one meetings with attendees.

On August 28, 2019 CrystalGenomics, Inc. (KOSDAQ: 083790) reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CG-745, a clinical stage histone deacetylase (HDAC) inhibitor being developed for several hematologic malignancies and solid tumors, for the treatment of patients with pancreatic cancer (Press release, CrystalGenomics, AUG 28, 2019, View Source;id=1821&page=1&num=126&nowpos=163&type=&sermun=&qu=&tb_name=eng_news&rt_page=/en/news/news.php [SID1234539162]).

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Dr. Joong Myung Cho, Chairman and Chief Executive Officer of CrystalGenomics, said, "We are pleased that CG-745 has received Orphan Drug Designation from the FDA for the treatment of pancreatic cancer. Currently our Phase II pancreatic cancer trial is still ongoing, and the results look promising thus far."

CG-745 is currently being studied in a Phase II clinical trial in combination with gemcitabine and erlotinib to evaluate its safety and efficacy for locally advanced unresectable, or metastatic pancreatic cancer. Additionally, there is another ongoing Phase II clinical trial to evaluate the safety and efficacy of CG-745 in patients with Myelodysplastic Syndrome (MDS) who have failed hypomethylating agents.

The FDA grants Orphan Drug Designation to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides incentives for sponsors to develop drugs and biologics for rare diseases. These incentives may include a partial tax credit for certain clinical trial expenditures, the waiver of certain FDA user fees, and if approved, potential eligibility for seven years of orphan drug marketing exclusivity, which is independent from intellectual property protection.

About Pancreatic Cancer
Pancreatic cancer is a deadly disease and one of the leading causes of cancer deaths in the US. The incidence of pancreatic cancer has increased over the past several decades and is considered the fourth leading cause of cancer deaths in the US as patients with this deadly disease have a 5-year survival rate of 8.5%. As pancreatic cancer tumors respond poorly to standalone chemotherapy and radiation, surgical resection is the only known curative treatment for patients with disease localized to the pancreas. However, patients with advanced or recurrent forms of the disease are not able to benefit from surgery, leaving these patients with limited effective treatment options and an overall survival of only up to 11.5%. Unfortunately, only 10% of pancreatic cancer patients have localized disease, leaving a large unmet medical need for treatment in 90% of the pancreatic cancer patient population.