Vertex to Announce Second-Quarter 2019 Financial Results on July 31

On July 17, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will reported its second quarter 2019 financial results on Wednesday, July 31, 2019 after the financial markets close (Press release, Vertex Pharmaceuticals, JUL 17, 2019, View Source [SID1234537573]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

Paragon Biosciences Launches Qlarity Imaging to Advance the First FDA-Cleared Artificial Intelligence Breast Cancer Diagnosis System

On July 17, 2019 Paragon Biosciences LLC — the Chicago-based life science innovator that invests in, builds, and advises bioscience companies — is reported the launch of its seventh portfolio company, Qlarity Imaging LLC, which was founded to harness the value of artificial intelligence (AI) to improve medical outcomes (Press release, Paragon Biosciences, JUL 17, 2019, View Source [SID1234537574]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Qlarity Imaging will further develop QuantX, the first-ever FDA-cleared computer-aided breast cancer diagnosis system in radiology. Qlarity plans to expand the diagnostic applications of its AI technology to additional image modalities and medical conditions, with the goal of improving patient care while lowering costs for hospitals and payers.

Qlarity Imaging acquired QuantX, the medical imaging AI system with intuitive displays, advanced analytics, and machine learning, initially developed at the University of Chicago based on research led by Dr. Maryellen L. Giger, and incubated at Quantitative Insights, a startup that had been launched with the support of the University of Chicago’s Polsky Center for Entrepreneurship and Innovation. A clinical study demonstrated the effectiveness of QuantX at helping radiologists interpret cancerous and non-cancerous breast lesions, leading to a 39% reduction in missed breast cancers without a reduction in specificity, as well as a 20% overall diagnostic improvement. The study led to the FDA clearance of the AI technology for breast cancer.

"By driving innovation across life sciences, Paragon fulfills its mission of improving outcomes for patients with severe medical conditions. So, we’re pleased to help further develop the first FDA-cleared, artificial intelligence-enabled diagnostic software for breast cancer MRIs," said Paragon Biosciences Chairman and CEO Jeff Aronin. "We are entering an exciting time where advances in supercomputing and machine learning make it possible for artificial intelligence to deliver on its promise for drug discovery, drug development, and diagnostics."

As a leader in innovating and building life science companies, Paragon’s capabilities and investment in Qlarity Imaging provide the company with the working capital needed to further develop and implement its computer-aided diagnosis system and explore expanded uses of AI-enabled diagnostic tools. Paragon Biosciences advises its portfolio companies on how to leverage AI technology to enhance the diagnostic insight of medical devices, accelerate the pace of drug development, and increase the efficacy of novel therapies.

Qlarity’s AI-enabled image processing and diagnostic algorithms are based on decades of research by Professor of Radiology Dr. Maryellen Giger, a pioneer in the field of computer-aided diagnosis. Now an advisor to Qlarity Imaging, Dr. Giger has conducted over 30 years of research in computer-aided diagnosis, including computer vision and machine learning for breast cancer, lung cancer, prostate cancer, lupus, and bone diseases.

"When we looked at how to best commercialize and scale QuantX, the computer-aided diagnostic system originally developed at the University of Chicago, Paragon Biosciences was the perfect partner," Dr. Giger said. "Paragon is already delivering on its promise, helping Qlarity Imaging to expand its management team, pursue new product opportunities, extend its customer base, and seek additional venture financing."

With today’s announcement, Qlarity Imaging becomes the third portfolio company launched by Paragon Biosciences in less than a year and the seventh launched since 2017. Over the last 18 months, Paragon Biosciences and its financial partners have invested and committed over $500 million to help Paragon’s portfolio companies develop innovative therapies and diagnostic tools.

Paragon Biosciences anticipates innovating, investing in, and launching additional portfolio companies this year and next.

Penumbra, Inc. Schedules Second Quarter 2019 Earnings Release and Conference Call for August 6, 2019

On July 16, 2019 Penumbra, Inc. (NYSE: PEN) reported that it will host a conference call to discuss financial results for the second quarter 2019 after market close on Tuesday, August 6, 2019 at 4:30 PM Eastern Time (Press release, Penumbra, JUL 16, 2019, View Source [SID1234537557]). A press release with second quarter 2019 financial results will be issued after market close that day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Webcast & Conference Call Information
The conference call can be accessed live over the phone by dialing (866) 393-4306 for domestic callers or (734) 385-2616 for international callers (conference id: 9790865), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for at least two weeks following the completion of the call.

Horizon Technology Finance to Announce Second Quarter 2019 Financial Results

On July 16, 2019 Horizon Technology Finance Corporation (NASDAQ: HRZN) ("Horizon") (the "Company"), a leading specialty finance company that provides capital in the form of secured loans to venture capital backed companies in the technology, life science, healthcare information and services, and cleantech industries, reported that it plans to release financial results for the second quarter ended June 30, 2019 on Tuesday, July 30, 2019, after the close of market trading (Press release, Horizon Technology, JUL 16, 2019, View Source [SID1234537558]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company has scheduled a conference call to discuss the results on Wednesday, July 31, 2019, at 9:00 a.m. ET. The conference call will feature remarks by Robert D. Pomeroy, Jr., Chairman and Chief Executive Officer, Gerald A. Michaud, President, and Daniel R. Trolio, Senior Vice President and Chief Financial Officer. To participate in the call, please dial (877) 407-9716 (domestic) or (201) 493-6779 (international). The conference ID is 13692493. Please dial into the call at least five minutes before the scheduled start time.

The conference call will also be available via a live listen-only webcast on the Company’s website, www.horizontechfinance.com. Please allow extra time prior to the call to visit the site and download any necessary software that may be needed to listen to the Internet broadcast.

For interested individuals unable to join the live conference call, a replay of the call will be available through August 1, 2019 at (844) 512-2921 (domestic) or (412) 317-6671 (international). The conference ID is 13692493. An online archive of the webcast will be available on the Company’s website for 30 days following the call.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for Second Quarter of 2019

On July 16, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 774 million in the second quarter of 2019 compared to USD 511 million in the second quarter of 2018, an increase of approximately 51% (Press release, Genmab, JUL 16, 2019, View Source [SID1234537543]). The 2019 second quarter net sales were USD 369 million in the U.S. and USD 405 million in the rest of the world.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Johnson & Johnson reported worldwide operational DARZALEX sales growth (excluding impact of foreign currency movements) between the two second quarter periods in 2018 and 2019, respectively, of approximately 57%. According to Johnson & Johnson, sales in the second quarter of 2019 included a one-time adjustment outside the U.S. related to the completion of pricing and reimbursement discussions in certain European countries, which positively impacted this worldwide operational growth by 16 percentage points.

Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.