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Autolus Therapeutics to Participate in Upcoming Investor Conferences in September

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.

CrystalGenomics Receives Orphan Drug Designation from the US FDA for CG-745 in Pancreatic Cancer

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]).

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.

EDAP Reports 2019 Second Quarter Results

On August 28, 2019 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in therapeutic ultrasound, reported financial results for the second quarter of 2019 and provided an update on strategic and operational developments (Press release, EDAP TMS, AUG 28, 2019, View Source [SID1234539117]).

Marc Oczachowski, EDAP’s Chief Executive Officer, said: "We are very pleased with our second quarter results that demonstrated another period of robust HIFU revenue growth, significant gross margin expansion and profitability. We have now posted three consecutive profitable quarters, and we are confident that this type of growth and consistency in our results could be maintained going forward. We were very pleased with the American Medical Association’s decision in June to accept our request for a Category 1 CPT code that will facilitate reimbursement for the ablation of malignant prostate tissue with HIFU technology. This is an important milestone for the adoption curve of HIFU technology, and, we believe will help our customers gain confidence in implementing next generation prostate cancer therapy programs. Importantly, we are still in the early stages of our Focal One marketing and sales development efforts, and as these activities continue, we expect to see continued robust expansion of our pipeline of sales prospects. We look forward to providing further updates on our progress in the coming months."

Second Quarter 2019 Results

Total revenue for the second quarter 2019 was EUR 12.5 million (USD 14.0 million), a 45.1% increase compared to EUR 8.6 million (USD 10.2 million) for the second quarter of 2018.

Total revenue in the HIFU business for the second quarter 2019 was EUR 4.6 million (USD 5.1 million), a 97.1% increase compared to EUR 2.3 million (USD 2.7 million) for the second quarter of 2018.

For the three months ended June 30, 2019, total revenue for the UDS division was EUR 7.9 million (USD 8.9 million), a 25.9% increase compared to EUR 6.3 million (USD 7.4 million) during the year-ago period.

Gross profit for the second quarter 2019 was EUR 6.3 million (USD 7.1 million), compared to EUR 3.6 million (USD 4.2 million) for the year-ago period. Gross profit margin on net sales was 50.7% in the second quarter of 2019, compared to 41.3% in the year-ago period.

Operating expenses were EUR 4.7 million (USD 5.3 million) for the second quarter of 2019, compared to EUR 4.6 million (USD 5.5 million) for the same period in 2018.

Operating profit for the second quarter 2019 was EUR 1.7 million (USD 1.9 million), compared to an operating loss of EUR 1.1 million (USD 1.3 million) in the second quarter of 2018.

Net income for the second quarter 2019 was EUR 1.4 million (USD 1.6 million), or earnings of EUR 0.05 per diluted share, as compared to a net loss of EUR 0.8 million (USD 0.9 million), or a loss of EUR 0.03 per diluted share in the year-ago period.

First six months 2019 Results

Total revenue for the first half of 2019 was EUR 22.6 million (USD 25.6 million), a 27.3% increase compared to EUR 17.8 million (USD 21.4 million) for the first half of 2018.

Total revenue in the HIFU business for the first six months of 2019 was EUR 8.4 million (USD 9.5 million), a 77.4% increase compared to EUR 4.8 million (USD 5.7 million) for the six months ended June 30, 2018.

For the six months ended June 30, 2019, total revenue for the UDS division was EUR 14.2 million (USD 16.0 million), a 9.0% increase compared to EUR 13.0million (USD 15.7 million) during the year-ago period.

Gross profit for the first half of 2019 was EUR 11.2 million (USD 12.6 million), compared to EUR 7.6 million (USD 9.1 million) for the year-ago period. Gross profit margin on net sales was 49.5% compared to 42.6% in the year-ago period.

Operating expenses were EUR 9.3 million (USD 10.5 million) for the first six months of 2019, compared to EUR 9.0 million (USD 10.9 million) for the same period in 2018.

Operating profit for the first half of 2019 was EUR 1.9 million (USD 2.1 million), compared to an operating loss of EUR 1.5 million (USD 1.8 million) in the first six months of 2018.

Net income for the first half of 2019 was EUR 1.7 million (USD 1.9 million), or earnings of EUR 0.06 per diluted share, as compared to a net loss of EUR 0.7 million (USD 0.8 million), or a loss of EUR 0.02 per diluted share in the year-ago period.

As of June 30, 2019, cash and cash equivalents, including short term investments, were EUR 16.3 million (USD 18.5 million).

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT on Thursday, August 29, 2019. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Thursday August 29th @ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13693076
Webcast: View Source

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."

Alder BioPharmaceuticals® to Present at Two Upcoming September Investor Conferences

On August 28, 2019 Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that members of the management team will provide a business overview and update at the Wells Fargo Securities 2019 Healthcare Conference at 2:25 p.m. ET on Wednesday, September 4, 2019 in Boston, MA and at the Morgan Stanley 17th Annual Global Healthcare Conference at 4:05 p.m. ET on Tuesday, September 10, 2019 in New York, NY (Press release, Alder Biopharmaceuticals, AUG 28, 2019, View Source [SID1234539116]).

The presentations will be webcast live on the Events & Presentations page of the Investors section of Alder’s website at View Source, or by following the links below in your web browser. An archived replay of the webcasts will be available on Alder’s website for at least 30 days after the live event concludes.

Wells Fargo: https://cc.talkpoint.com/well001/090419a_js/?entity=66_M510UX8

Morgan Stanley: https://cc.talkpoint.com/morg007/090919b_js/?entity=90_K3MMOX0

Oncternal Expands Leadership Team with Appointment of Frank Hsu, M.D., as Chief Medical Officer, and Rajesh Krishnan, Ph.D., as Senior VP CMC and Manufacturing

On August 28, 2019 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biotechnology company developing potential first-in-class product candidates for cancers with critical unmet medical needs, reported the appointment of Frank Hsu, M.D., as Chief Medical Officer, and Rajesh Krishnan, Ph.D., as Senior Vice President, Chemistry, Manufacturing and Controls (CMC) and Manufacturing (Press release, Oncternal Therapeutics, AUG 28, 2019, View Source [SID1234539115]).

Dr. Hsu brings to Oncternal extensive experience in cancer drug development, most recently from Immune Design Corporation, where he served as Vice President and Head of Oncology, responsible for development and execution of the company’s clinical programs, supporting preclinical and business efforts. Dr. Krishnan brings a wealth of experience in manufacturing, process development, technology transfer and technical operations, most recently from Dynavax Technologies Corporation, where he served as Vice President, Process Development and Manufacturing Sciences.

"I am very excited to announce these two key executive appointments. Frank Hsu’s arrival reflects the growing importance of clinical drug development at Oncternal," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We believe that Frank’s wealth of expertise in oncology drug development and regulatory approval, his deep academic oncology background and proven ability to collaborate and lead teams make him an ideal fit for Oncternal as we advance our pipeline of potential first-in-class targeted therapies. Raj Krishnan’s appointment also reflects Oncternal’s commitment to advancing its diverse targeted therapeutic candidates. Raj has extensive experience and a proven track record of innovation and success in cross-functional CMC programs involving biologic and small molecule product candidates. We believe that the addition of these two outstanding professionals to the Oncternal executive team will be instrumental as we continue to advance our lead clinical product candidate, cirmtuzumab, along with our clinical TK216 product candidate and our preclinical ROR1 targeted CAR-T program."

Dr. Hsu stated, "This is an exciting time at Oncternal, with its diversified clinical pipeline targeting emerging cancer biology and multiple indications, including both hematological and solid tumor programs. I look forward to working with the talented individuals at Oncternal to execute the Company’s clinical development programs."

"I am delighted to have the opportunity to bring my extensive experience with process development and manufacturing of both biologic and small molecule product candidates to Oncternal," said Dr. Krishnan.

Dr. Hsu has held positions of increasing responsibility in both biotech and academic settings. From 2013 through 2018, he served as Vice President and Head of Oncology at Immune Design Corporation prior to its acquisition by Merck Co., Inc., where he was responsible for development of several immuno-oncology programs. From 2012 until 2013, Dr. Hsu served as Chief Medical Officer at Zyngenia, Inc., where he was responsible for development of its multivalent protein therapeutics. From 2002 through 2012, he served as Senior Medical Director at Genzyme Corporation prior to its acquisition by Sanofi, S.A. Previously, Dr. Hsu was a faculty member at Yale University, serving as an Assistant Professor of Medicine in the Section of Oncology and co-Director/Director of the Immunology Research Program of the Yale Cancer Center. Dr. Hsu holds a B.S. degree in biology from Stanford University, and an M.D. degree from Harvard Medical School and the Health Science and Technology Program at the Massachusetts Institute of Technology. He completed his internship/residency in Internal Medicine at the University of California, San Francisco and his oncology training at Stanford University.

Dr. Krishnan has experience across a range of CMC and manufacturing technologies for U.S. and international manufacturing sites, involving both internal and partnered programs. From 2018 until 2019, he served as Vice President, Process Development and Manufacturing Sciences at Dynavax Technologies Corporation, where he led manufacturing, drug process development, process validation and technology transfer efforts for commercial and clinical development programs. From 2012 through 2017, Dr. Krishnan served in several positions at Gilead Sciences, Inc., most recently as Head, Biologics Drug Substance Process Development. Previously, he served in positions of increasing responsibility at Merck & Co., Inc., Amgen Inc. and Pfizer from 2000 through 2012. Dr. Krishnan holds a B.S.E. degree in chemical engineering from Princeton University, an M.S. degree in chemical engineering from the University of California, Davis, and a Ph.D. degree in Biochemical Engineering from the University of California, Davis.