AbbVie to Present at the UBS Virtual Healthcare Conference

On May 14, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the UBS Virtual Healthcare Conference on Wednesday, May 20, 2020 (Press release, AbbVie, MAY 14, 2020, View Source [SID1234557978]). Michael Severino, M.D., vice chairman and president and Robert A. Michael, executive vice president and chief financial officer, will present at 9:50 a.m. Central time.

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!

A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

Vivoryon Therapeutics AG Reports First Quarter 2020

On May 14, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY, ISIN DE0007921835) reported its first quarter business update for the period ending March 31, 2020 (Press release, Vivoryon Therapeutics, MAY 14, 2020, View Source [SID1234557966]). The first quarter 2020 report is available for download on the Company website: View Source

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!

KEY HIGHLIGHTS

Vivoryon Therapeutics and Nordic Bioscience Entered into a Research and Development Collaboration
Vivoryon Therapeutics Announced Update on Phase 2b Alzheimer’s Clinical Trial, VIVIAD

POST PERIOD HIGHLIGHTS

Vivoryon Therapeutics Initiated Development Program for Meprin Protease Inhibitors with Intended Therapeutic Use in Fibrosis, Cancer and Alzheimer’s Disease
Vivoryon Therapeutics Announced Outcome of Exclusive Option Deal with MorphoSys

CORPORATE REVIEW

Financial Review (According to IFRS)

In the first quarter of 2020, research and development expenses rose to EUR 2,783k compared to EUR 447k in the first quarter of 2019. This increase was mainly driven by costs associated with the ramp-up phase of the clinical Phase 2b study in Alzheimer’s disease. General and administrative expenses in the first quarter 2020 resulted in EUR 580k, compared to EUR 488k in 2019. Vivoryon’s finance expenses amounted to EUR 300k in the reporting period. In line with corporate planning, revenues were not generated in the reporting period. The net loss in the first quarter resulted in EUR 3,328k compared to EUR 910k in the first quarter of 2019.

All results are within management expectations.

Vivoryon Therapeutics held EUR 20.2 million in cash and cash equivalents and EUR 19.7 million in other short-term securities as of March 31, 2020.

OPERATIONAL REVIEW

Vivoryon Therapeutics and Nordic Bioscience entered into a Research and Development Collaboration

Vivoryon announced that it entered into a research and development collaboration with Nordic Bioscience for the clinical development of PQ912 for Alzheimer’s Disease (AD). In addition to taking on the role as CRO (Clinical Research Organization) for Vivoryon Therapeutics’ Phase 2b trail, VIVIAD, Nordic Bioscience and Vivoryon will enter into a collaboration to benefit from Nordic Bioscience’s world leading expertise in the development of blood-based biomarkers for the identification of specific patients that may benefit most from treatment with PQ912, Vivoryon’s Phase 2 clinical-stage candidate in AD.

Vivoryon Therapeutics Announced an Update on Phase 2b Alzheimer’s Clinical Trial, VIVIAD

The clinical trial, VIVIAD, derived from "advancing disease modifying treatment and non-invasive diagnostics of Alzheimer’s disease," has been designed to test the efficacy and safety of various doses of PQ912 in 250 early-stage Alzheimer’s patients in a randomized, placebo-controlled study over the course of 48 to 96 weeks.

The primary endpoints of the study will assess the safety and tolerability of PQ912 in addition to its efficacy on working memory and attention. The secondary endpoints include long-term safety and tolerability of PQ912 and its efficacy on brain activity, cognition and daily activities.

Vivoryon has also added exploratory parameters selected with the rationale of advancing less invasive diagnostic technologies. This will include the Winterlight Labs speech assessment, the use of EEG to test neuronal network activity and connectivity, as well as a set of blood-based biomarkers run by Nordic Bioscience. The inclusion of these parameters will further strengthen PQ912’s data package and introduce more innovative and less demanding diagnostic tools to patients in the future.

POST PERIOD HIGHLIGHTS

Vivoryon Therapeutics Initiated Development Program for Meprin Protease Inhibitors with Intended Therapeutic Use in Fibrosis, Cancer and Alzheimer’s Disease

In March 2020, the Company entered into a research collaboration with the Fraunhofer Institute for Cell Therapy and Immunology (IZI), acquiring related patents for a meprin protease inhibitor and assay platform, to advance first-in-class small molecule meprin inhibitors.

The collaboration will combine Vivoryon’s expertise in translating basic research into marketable small molecule therapeutics with the department’s focus on discovery and development of new treatment options that target recognized pathologic post-translational modifications.

Vivoryon Therapeutics Announced Outcome of Exclusive Option Deal with MorphoSys

MorphoSys will not execute the option deal to license Vivoryon’s small molecule QPCTL inhibitors for oncology.

Vivoryon will continue to evaluate QPCTL inhibitors in oncology based on preclinical studies conducted in collaboration with the University of Kiel and will, based on existing proof-of-concept data, remain open for opportunities to collaborate with pharma partners in upcoming clinical development steps.

Vivoryon Therapeutics´ Ordinary General Meeting of Shareholders postponed until September

The Ordinary General Meeting of Vivoryon Therapeutics will be postponed until the 2nd half of September 2020 due to coronavirus restrictions.

Oasmia Pharmaceutical announces poster presentation at American Society of Clinical Oncology 2020 annual meeting

On May 14, 2020 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that data collected from the Company’s development program of docecal, a solvent-free nanoparticle micellar formulation of docetaxel have been accepted for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Annual meeting taking place between May 29 -June 02, 2020 (Press release, Oasmia, MAY 14, 2020, View Source [SID1234557965]).

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 poster, entitled; "Pharmacokinetics, safety and early activity of a nanoparticle micellar formulation of docetaxel in women with metastatic breast cancer: Results of two randomized trials (phase I and II)" will be presented by Dr Markus Joerger, MD, PhD, Cantonal Hospital, St. Gallen, Switzerland at the session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology. The phase I study was performed to determine the pharmacokinetics of docetaxel micellar in 30 patients and the phase II study was a randomized active-controlled study where 200 patients were treated. The bioequivalence of docetaxel micellar to docetaxel and the improved safety profile will be presented and discussed in relation to the future development program of the product.

"We are pleased to present and discuss this important research, which highlights results from our pipeline. Our clinical program continues to advance our XR17 technology platform," says Dr. Reinhard Koenig, Acting Chief Medical Officer at Oasmia Pharmaceutical.

ASCO is an organization for clinical oncologists and provides recommendations for clinical practices and publishes the scientific journal Journal of Clinical Oncology among other things. Due to public health safety concerns related to COVID-19, this year’s meeting will be a global virtual event held during the dates of the originally planned in-person Annual meeting.

Business Results for the First Quarter of the Fiscal Year Ending December 31, 2020 (Unaudited)

On May 14, 2020 Kuraray reported that First Quarter of the Fiscal Year Ending December 31, 2020 (Press release, Kuraray, MAY 14, 2020, https://pdf.irpocket.com/C3405/yCGV/mXhw/evng.pdf [SID1234557964])

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!

1. Consolidated Financial Results for the First Quarter of the Fiscal Year Ending December 31, 2020 (January 1, 2020 to March 31, 2020)

(1) Consolidated Operating Results

(2) Consolidated Financial Position

2. Dividends

3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2020 (January 1, 2020 to December 31, 2020) Regarding the full-year forecasts of consolidated financial results, due to the difficulty of reasonably calculating the impact of COVID-19 pandemic on the Group’s results from the third quarter onward, we have temporarily withdrawn the forecasts released on February 13, 2020 and it is to be determined. We will swiftly release a forecast once calculations become possible. [Reference]

(1) Changes in Important Subsidiaries during the Period (Changes in Special Subsidiaries Involving Changes in the Scope of Consolidation) Added: No companies Excluded: No companies

(2) Adoption of Special Accounting Practices in the Preparation of Quarterly Consolidated Financial Statements No

(3) Changes in Accounting Principles, Procedures and Presentation Methods in Connection with the Preparation of Quarterly Consolidated Financial Statements

1. Changes following revision of accounting standards:

No 2. Changes besides

1. above:

No 3. Changes in accounting estimates:

No 4. Restatement:

No (4) Number of Shares Issued and Outstanding (Common Shares)

1. Number of shares issued and outstanding (including treasury stock) as of the period-end: As of March 31, 2020 354,863,603 shares As of December 31, 2019 354,863,603 shares

2. Number of treasury shares as of the period-end: As of March 31, 2020 11,005,846 shares As of December 31, 2019 11,130,834 shares 3. Average number of shares for the period (cumulative): As of March 31, 2020 343,781,244 shares As of March 31, 2019 348,198,564 shares Note: It is not required that this type of earnings report be audited.

Cautionary Statement with Respect to Forecasts of Consolidated Business Results (Cautionary note regarding forward-looking statements) The results forecasts presented in this document are based upon currently available information and assumptions deemed rational. A variety of factors could cause actual results to differ materially from forecasts. Please refer to "

1. Qualitative Information regarding Business Results

(3) Basis for the Revision in Forecasts, Including Consolidated Operating Results Forecasts" on page 4 of the Attachment for the assumptions used.

1. Qualitative Information regarding Business Results (1) Overview of Consolidated Business Results In the first quarter of fiscal 2020 (January 1, 2020–March 31, 2020), the world economy dramatically decelerated due to the serious impacts on consumption and production of the restrictions on economic activity to counter the global spread of COVID-19. Consequently, consolidated operating results for the first quarter of fiscal 2020 are as follows: net sales fell ¥4,719 million, or 3.3%, compared with the previous fiscal year to ¥136,927 million; operating income decreased ¥2,660 million, or 18.2%, to ¥11,971 million; ordinary income decreased ¥1,488 million, or 11.6%, to ¥11,306 million; and net income attributable to owners of the parent increased ¥619 million, or 10.2%, to ¥6,705 million.

The global spread of COVID-19 remains a serious issue with no end in sight regarding containment. In addition, it is expected to take a long time for economic activity to return to normal. Even amid this kind of environment, we will continue to supply needed products around the world. We realize the importance of the role that has been given to us, and we will maintain our business activities while thoroughly ensuring safety and working to prevent infection. The Group’s long-term vision, Kuraray Vision 2026, is to become a "Specialty Chemical Company, growing sustainably by incorporating new foundational platforms into its own technologies." As we continue working to realize this vision, we will steadily take specific measures in line with the key management strategies underlined in the medium-term management plan "PROUD 2020" from a medium-to long-term perspective.

Through these efforts, we will also continue working to establish a new business portfolio. Results by Business Segment Vinyl Acetate Sales in this segment decreased 3.6% year on year to ¥63,866 million, and segment income fell 22.4% year on year to ¥8,387 million.

(1) The volume of PVA resin declined due to stagnant global demand. Due to the effect of an LCD panel inventory adjustment continuing from the second half of the previous fiscal year, shipments of optical-use poval film stayed level with the previous year. In addition, sales of PVB film remained weak, mainly for automotive applications. However, sales of water-soluble PVA film steadily expanded for use in unit dose detergent packets.

(2) The sales volume of EVAL ethylene vinyl alcohol copolymer (EVOH resin) increased for food packaging applications but sales for gas tank applications were weak due to a decline in the number of vehicles produced. Isoprene Sales in this segment decreased 3.4% year on year to ¥13,162 million, and segment income fell 16.0% year on year to ¥3,140 million.

(1) Shipments of isoprene chemicals declined, especially those to China. Sales of SEPTON thermoplastic elastomer struggled in Asia, but U.S. demand remained firm.

(2) The sales volume of GENESTAR heat-resistant polyamide resin increased due to anticipatory demand in China for electric and electronic device applications. Demand for connectors for automotive devices remained favorable. Functional Materials Sales in this segment increased 1.0% year on year to ¥30,766 million, and segment income grew 12.5% year on year to ¥1,268 million.

(1) Although the sales volume of methacrylic resins and sheets increased, the methacrylate business was affected by worsening market conditions.

(2) In the medical business, sales were steady in the first quarter due to anticipatory demand for dental materials, especially exports, but there are concerns about decelerating demand as many dental clinics have closed, mainly across the United States and Europe.

(3) As for Calgon Carbon, demand remained steady in North America, especially for drinking water applications while demand was sluggish in Europe. In the Carbon Materials business, sales of high value-added products increased. Fibers and Textiles Sales in this segment fell 12.5% year on year to ¥14,467 million while segment income decreased 18.1% year on year to ¥916 million.

(1) The sales volume of CLARINO man-made leather decreased due to stagnant demand in Asia and Europe.

(2) In fibers and industrial materials, the performance of KURALON for cement reinforcement use remained weak. Sales of products used in reinforcing rubber were negatively affected by a decline in vehicle production. However, sales results for VECTRAN were firm.

(3) In consumer goods and materials, sales of KURAFLEX were weak as demand for cosmetic and automotive applications fell despite an increase in sales for mask-related applications. Trading In fiber-related businesses, sales of sportswear-use products remained steady, but sales of resins and chemicals targeting Japanese and Chinese markets struggled. As a result, segment sales decreased 5.1% year on year to ¥29,771 million, and segment income rose 9.9% to ¥961 million. Others In other business, due to weak sales of domestic affiliates, segment sales declined 18.0% year on year to ¥11,661 million, and segment income fell 67.2% to ¥43 million.

(2) Overview of Financial Position Total assets increased ¥1,950 million from the end of the previous fiscal year to ¥993,099 million mainly because of a ¥4,757 million increase in cash and cash deposits and a ¥4,515 million increase in inventory assets that offset a ¥3,716 million decrease in intangible fixed assets and a ¥4,204 million decrease in investment securities. Total liabilities increased ¥10,693 million to ¥463,297 million due to factors that included the issuance of commercial paper totaling ¥26,000 million and a ¥23,364 million increase in long-term loans payable, despite a ¥29,392 million decrease in accrued expenses. Net assets fell ¥8,742 million to ¥529,802 million. Equity attributable to owners of the parent amounted to ¥515,406 million, for an equity ratio of 51.9%.

(3) Basis for the Revision in Forecasts, Including Consolidated Operating Results Forecasts Due to economic restrictions to combat the global spread of COVID-19, first quarter results for all segments were weak as demand for automobiles, electronic devices, displays and other mainstay Kuraray applications stagnated. Further deterioration in demand from the second quarter is unavoidable, and we need to respond accordingly with production adjustments and other measures. We expect this to have a large impact on our operating results. Based on these circumstances, the forecast of consolidated operating results for the second quarter of fiscal 2020 (January 1, 2020 to June 30, 2020) is as shown below. Furthermore, regarding the full-year forecasts of the consolidated financial results, due to the difficulty of reasonably calculating the impact of COVID-19 pandemic on the Group’s results from the third quarter onward, we have temporarily withdrawn the forecasts released on February 13, 2020 and it is to be determined. We will swiftly release a forecast once calculations become possible. In addition, although we recorded an extraordinary loss in fiscal 2019 related to the litigation over the fire at the U.S. subsidiary in May 2018, if it is determined that we need to revise our results forecasts in the course of future negotiations, we will make a swift announcement.

Chi-Med Highlights Clinical Data to be Presented at the Upcoming ASCO20 Virtual Scientific Program

On May 14, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that new and updated analyses on the ongoing studies of savolitinib, surufatinib, and fruquintinib will be presented at the upcoming ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, taking place on May 29-31, 2020 (Press release, Hutchison China MediTech, MAY 14, 2020, https://www.chi-med.com/asco20-virtual-scientific-program/ [SID1234557962]).

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!

Chi-Med plans to hold a conference call on the following Monday, June 1, to discuss the results.

SAVOLITINIB
Title: Phase II study of savolitinib in patients (pts) with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping
Lead Author: Shun Lu, MD, PhD., Shanghai Chest Hospital, Shanghai Jiao Tong University
Session: Lung Cancer—Non-Small Cell Metastatic
Abstract Number: 9519

Title: SAVOIR: A phase III study of savolitinib versus sunitinib in pts with MET-driven papillary renal cell carcinoma (PRCC)
Lead Author Toni K. Choueiri, MD, Dana-Farber Cancer Institute and Harvard Medical School
Session: Genitourinary Cancer—Kidney and Bladder
Abstract Number: 5002

SURUFATINIB
Title: Efficacy and safety of surufatinib in United States (US) patients (pts) with neuroendocrine tumors (NETs)
Lead Author: Arvind Dasari, MD, MS, MD Anderson Cancer Center
Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4610

Title: Health-related quality-of-life results from SANET-ep: A phase III study of surufatinib versus placebo for advanced extrapancreatic neuroendocrine tumors
Lead Author Chunmei Bai, MD, Peking Union Medical College Hospital
Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4613

FRUQUINTINIB (Publication only)
Title: Early carcinoembryonic antigen (CEA) dynamics to predict fruquintinib efficacy in FRESCO, a 3+ line metastatic colorectal carcinoma (mCRC) phase III trial
Lead Author: Yuxian Bai, Harbin Medical University Cancer Hospital
Abstract Number: e16001

Title: Efficacy and safety of fruquintinib in the treatment of poor patients with metastatic gastrointestinal cancer
Lead Author: Yanzhi Cui, MD, Tumour Institute, Fourth Hospital of Hebei Medical University
Abstract Number: e16028

About Savolitinib
Savolitinib is an inhibitor of MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective MET inhibitors. In clinical studies to date, involving over 1,000 patients, savolitinib has shown promising signs of clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.

About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.

A New Drug Application ("NDA") for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration (NMPA) and granted Priority Review status in December 2019. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET is being prepared for submission. We are preparing for regulatory interactions in the U.S., Europe and Japan to confirm clinical development and path to registration. In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET, and Orphan Drug Designation for pancreatic NET. Additionally, surufatinib is in several late-stage and proof-of-concept trials in China, including in combination with immunotherapies, and proof-of-concept clinical trials in the U.S.

Chi-Med currently retains all rights to surufatinib worldwide.

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for combinations with other anti-cancer therapies.

Fruquintinib was approved for marketing in China by the NMPA in September 2018 and commercially launched by Eli Lilly and Company ("Lilly") in late November 2018 under the brand name Elunate, for the treatment of patients with metastatic colorectal cancer ("CRC"). We also intend to initiate a Phase III registration study for CRC in the U.S., Europe and Japan. A Phase III registration study is also ongoing in China for the treatment of patients with gastric cancer, in combination with paclitaxel. Additionally, fruquintinib is in several other proof-of-concept trials in China and the U.S., including in combination with immunotherapies.

Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.