On August 29, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that management plans to participate at the following events in September 2019 (Press release, Celyad, AUG 29, 2019, View Source [SID1234539118]):

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Wells Fargo Healthcare Conference
Date: Wednesday, September 4, 2019
Presentation Time: 4:10 p.m. EDT
Location: Boston, Massachusetts, USA
Webcast: Celyad’s website, under Events & Webcasts section

CAR-TCR Summit
Date: September 10 – 13, 2019
Location: Boston, Massachusetts, USA

International Conference on Lymphocyte Engineering (ICLE)
Date: September 13 – 15, 2019
Location: London, United Kingdom

KBC Annual Healthcare Conference
Date: Thursday, September 26, 2019
Location: Brussels, Belgium

On August 29, 2019 Milestone Pharmaceuticals Inc. reported that members of the Milestone management team will participate in the following September investor conferences (Press release, Milestone Pharmaceuticals, AUG 29, 2019, View Source [SID1234539135]):

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Citi’s 14th Annual Biotech Conference on Thursday, September 5, 2019 in Boston, MA
Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Disease on Tuesday, September 24, 2019 in New York, NY

On August 29, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported financial results for the six months ended June 30, 2019 (Press release, Can-Fite BioPharma, AUG 29, 2019, View Source [SID1234539119]).

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Clinical Development and Corporate Highlights During Q2 2019 Include:

Received Payments for New Distribution Deals for Piclidenoson and Namodenoson in South Korea – During the second quarter, Chong Kun Dang Pharmaceuticals (CKD) paid Can-Fite $1,000,000 upfront, with up to an additional $5,000,000 due upon completion of milestones, plus transfer pricing on the drug for an expanded distribution deal for Namodenoson in South Korea for the indication of NASH. This expanded distribution deal, which was signed in the first quarter of 2019, expands upon the original agreement between Can-Fite and CKD for Namodenoson in the treatment of liver cancer in South Korea. Additionally, in the weeks following the end of the second quarter, Can-Fite entered into an exclusive distribution agreement with Kyongbo Pharm for Piclidenoson in the treatment of psoriasis in South Korea in a deal with upfront and milestone payments of up to $4,000,000 plus transfer pricing on the drug, upon regulatory approval in South Korea. Can-Fite received an upfront payment of $750,000 from Kyongbo Pharm.
Preparing for End-of-Phase II Study and Initiation of Planned Phase III for Namodenoson in Liver Cancer – The Company is now preparing for an end-of-Phase II meeting with the FDA in which Can-Fite will review the data from its recently completed Phase II study in patients with hepatocellular cancer (HCC), the most common form of liver cancer, and present the design of its planned Phase III trial, which it expects to initiate following agreement with the FDA. Namodenoson is approved and available for use under Compassionate Use guidelines for the treatment of advanced liver cancer in Israel with patients at the Rabin Medical Center by key opinion leader Salomon M. Stemmer, MD, Principal Investigator of the Company’s completed Phase II liver cancer study.
Phase II Liver Cancer Data Presented at ASCO (Free ASCO Whitepaper) – Data from Can-Fite’s recently completed Phase II trial in patients with HCC was presented at the late-breaking abstract session of the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the world’s largest clinical cancer research meeting. The most impressive finding was that in the largest subgroup of patients, those with Child Pugh B7, 44% of the patients treated with Namodenoson were alive at one-year post treatment compared to 18% in the placebo group, despite the trial not achieving its primary endpoint.
Anti-NASH Effects of Namodenoson Presented at the International Conference on Fatty Liver – Can-Fite presented compelling preclinical data showing Namodenoson improved liver function through its anti-inflammatory, anti-fibrotic, and anti-steatotic effects at a podium presentation in a session ‘Selected Abstracts of Excellence’. The presentation titled, "Namodenoson anti-NAFLD/NASH Activity is Mediated via De-regulation of the Wnt/β-catenin Pathway" was delivered at the 2nd Annual International Conference on Fatty Liver (ICFL 2019) in Berlin.
Phase II Liver Cancer Data Accepted for Presentation at ILCA Conference – Findings from Can-Fite’s Phase II study in liver cancer have been accepted for presentation at the International Liver Cancer Association (ILCA) annual meeting which brings together the leading thought leaders, researchers, and physicians in the treatment of liver cancer. Can-Fite is scheduled to deliver an oral presentation titled, "The Safety and Efficacy of Namodenoson in the Second Line Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients with Underlying Child-Pugh B (CPB) Liver Cirrhosis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled" on September 22, 2019.
Cash Infusion of $11 Million from Distribution Deals and Equity Raise – During the second quarter, Can-Fite raised a total of $9,200,000 through two equity offerings in April and May. Additionally, the Company received up-front payments from distribution agreement for its drugs in specific territories and indications in the amount of $1,000,000, during the second quarter and $750,000 following the end of the second quarter.
"As we advance our clinical pipeline into Phase III studies, the demand for safe and effective drugs in our chosen indications is evidenced through the distribution agreements that we continue to enter for Piclidenoson and Namodenoson in the global market. In the coming months, we expect to announce top line results from our Phase II study of Namodenoson in the treatment of NASH," stated Can-Fite CEO Pnina Fishman.

Financial Results

Revenues for the six months ended June 30, 2019 were $0.7 million compared to revenues of $0.9 million during the first six months of 2018. The decrease in revenues was mainly due to the recognition of a higher portion of the $2.2 million advance payment received in January 2018 under the distribution agreement with Gebro in the six month period ended June 30, 2018.

Research and development expenses for the six months ended June 30, 2019 were $3.9 million compared with $2.6 million for the same period of 2018. Research and development expenses for the first six months of 2019 comprised primarily of expenses associated with the Phase II studies for Namodenoson in the treatment of NASH and HCC, as well as expenses for ongoing Phase III studies of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis.

General and administrative expenses were $1.3 million for the six months ended June 30, 2019 compared to $1.8 million for the same period in 2018. The decrease is primarily due to a decrease in professional services and investor relations expenses.

Financial expense, net for the six months ended June 30, 2019 was $0.3 million compared to financial income, net of $0.6 million for the same period in 2018. The increase in financial expense, net in the first six months of 2019 is mainly due to fair value revaluation of the Wize Pharma Inc. shares which are classified under short term investment.

Can-Fite’s net loss for the six months ended June 30, 2019 was $4.9 million compared with a net loss of $3.0 million for the same period in 2018. As of June 30, 2019, Can-Fite had cash and cash equivalents of $8.2 million as compared to $3.62 million at December 31, 2018. The increase in cash during the six months ended June 30, 2019 is due to net cash provided by financing activity of $10.1 million which was offset by net cash used in operating activity of $5.5 million. As of the date hereof, the Company estimates that it has approximately $6 million in cash and cash equivalents.

In April and May 2019, the Company raised $3.2 million and $6 million in gross proceeds, respectively, in registered direct offerings.

The Company’s consolidated financial results for the six months ended June 30, 2019 are presented in accordance with International Financial Reporting Standards.

On August 29, 2019 Luye Pharma Group (02186.HK) reported its financial results for the first half of 2019 on August 28 (Press release, Luye Pharma, AUG 29, 2019, View Source [SID1234539136]). The results show the company has achieved a revenue of RMB 3.131 billion, up 42.1% year-on-year; EBITDA reached RMB 1.263 billion, up 44.1% year-on-year, while profit attributed to shareholders reached RMB 767 million, up 36.2% year-on-year.

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The pharmaceutical industry experienced vast changes in the first half of 2019. However, Luye Pharma is firmly sticking to its development strategy of "innovation" and "internationalization", focusing on four core therapeutic areas, with a particular attention to the central nervous system (CNS) and oncology therapeutic areas, achieving satisfactory performance returns and laying solid foundations for the global launch and commercial operations for a number of new drugs.

A Number of New CNS Drugs to Be Launched Soon

The U.S. Food and Drug Administration (FDA) has accepted filing of LY03004’s (Extended-Release Microspheres for Injection) new drug application (NDA). LY03004 for the treatment of schizophrenia and bi-polar disorder is the first innovative formulation from China to have an NDA accepted by the FDA, indicating that China’s first independently-developed microsphere product is likely to be on U.S. market in the near future. The company will file the NDA for LY03004 in China in the second half of this year.

Rivastigmine transdermal patch products in the CNS therapeutic area have also achieved remarkable progress: the multi-day transdermal patch has completed a pivotal study for the treatment of Alzheimer’s disease in Germany. The once-a-day transdermal patch will soon be launched in China, while the high dosage strength (13.3mg/24h) once-a-day transdermal patch has received market authorization in Germany.

The registration application for Pramipexole Dihydrochloride Sustained Release Tablet for the treatment of Parkinson’s disease has been accepted by China’s National Medical Products Administration. Ansofaxine Hydrochloride Extended-Release Tablet for the treatment of depression (LY03005) and Rotigotine Extended-Release Microspheres for Injection for the treatment of Parkinson’s disease (LY03003) have filed a clinical trials application and began phase I clinical trials in Japan, respectively. These two investigational drugs have entered the late clinical stage in China and the U.S.

Outside of the CNS business, four other investigational biosimilar drugs have started clinical trials in China, among which LY01008 (a biosimilar of Avastin) and LY6006 (a biosimilar of Prolia) have undergone smooth progress in the phase III clinical trials stage.

R&D expense has increased by 30.6% year-on-year in the first half of 2019, and Luye Pharma will continue increasing its investment in R&D, with more efforts made to speed up new drug registration and launch processes.

Comprehensive Strategic Planning Focused on Core Therapeutic Areas

Luye Pharma has a long-term focus on the four therapeutic areas with the largest scale and fastest growth: oncology, central nervous system (CNS), cardiovascular and metabolism, with a strategic focus given to oncology and CNS. Key products are seeing stable double-digit growth, especially Lipusu, Seroquel, Xuezhikang, Maitongna and Beixi.

In the oncology therapeutic area, of note is the inclusion of the innovative paclitaxel liposome formulation, Lipusu, as a first-line drug in the 2019 Chinese Society of Clinical Oncology (CSCO) Guidelines on Diagnosis and Treatment of Primary Lung Cancer, a strong driver of sales growth for relative indications. Luye Pharma has been actively involved in clinical data collection following the drug’s launch, with several research projects completed including "Comparison of the Efficacy of Lipusu with Cisplatin vs. Gemcitabine with Cisplatin for the First-Line Treatment of Advanced Squamous Cell Lung Carcinoma" and "A Study on the Safety and Effectiveness of Sintilimab with Platinum-Based Chemotherapy and Lipusu for the Neoadjuvant Therapy of Esophagus Cancer", among others, bringing greater benefit to more patients.

In the central nervous system therapeutic area, global business integration for Seroquel and Seroquel XR is progressing smoothly to date. A Nervous System Drug Business Unit has been established in China, and a global business network and global pharmacovigilance system also built up, meanwhile, the product’s marketing authorization transfer for various countries and regions has been progressing well, laying a solid foundation for global marketing of the Seroquel product series and commercialization of the upcoming new drugs in the central nervous system therapeutic area.

External Collaborations Accelerate Development of R&D Product Pipelines and Commercial Capability

Luye Pharma has embarked on a number of license-in agreements and collaborations in the first half of 2019, based on the company’s strategy of internationalization, which supports product pipeline development and improvements to commercial capability.

In April of this year, Luye Pharma and an international biopharmaceutical company PharmaMar entered into a license development and commercialization agreement with respect to an innovative anticancer investigational drug, Zepsyre (Lurbinectedin), which will strengthen Luye Pharma’s innovative product pipelines in oncology and generate synergy by leveraging the company’s strong marketing capability in mainland China. Zepsyre was granted orphan drug designation by the U.S. FDA for the treatment of patients with Small Cell Lung Cancer in August 2018. Recently, the FDA also agreed with the company’s proposal to file for accelerated approval of Zepsyre’s New Drug Application (NDA) for monotherapy in the treatment of second-line small cell lung cancer.

Luye Pharma has made increasing efforts to speed up the introduction of new drugs to China and bring the company’s original products to overseas markets. Exclusive promotion rights for Xuezhikang Capsules were granted to AstraZeneca in mainland China, following which both parties signed a Memorandum of Understanding to promote Xuezhikang Capsules in international markets. Currently, in addition to mainland China, AstraZeneca is also granted the right to promote the product in Singapore, accelerating Xuezhikang’s route to other international markets.

On August 29, 2019 ADCendo, a spin-out from the University of Copenhagen and Rigshospitalet, reported having been accepted into the BioInnovation Institute (BII) Creation House program (Press release, ADCendo, AUG 29, 2019, View Source [SID1234573153]). As part of the program, ADCendo has secured a convertible loan of 10 million DKK for furthering its novel antibody-drug conjugates (ADCs) being developed for treatment of cancers.
In 2017, following publication of scientific proof-of-concept, ADCendo was established as a spin-out from the Finsen Laboratory of Rigshospitalet and the University of Copenhagen, with the purpose of developing a new type of targeted anti-cancer drug, in the form of antibody-drug conjugates (ADCs) directed at a novel target receptor, uPARAP. An approach that potentially enables targeted therapy in several cancer forms where expression of the target has been found to be highly upregulated, including soft-tissue sarcoma, osteosarcoma, glioblastoma multiforme (GBM) and triple-negative breast cancer. Furthermore, recent research suggests that targeting uPARAP-positive stromal cells (healthy cells surrounding a solid tumor) with this approach, may potentially offer opportunities for treating several much more commonly occurring carcinomas, including breast, colon, pancreatic, prostate, ovarian and renal cancers.

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CSO of ADCendo and group leader at The Finsen Laboratory, Niels Behrendt, explains: "Based on our early results obtained at the Finsen laboratory, we were granted a pre-seed grant from Novo Holdings enabling us to make significant improvements to the overall performance of our early ADC candidates. Our results have been very well received by our international ADC network, and with the expanded access to BII, as well as the additional financial support, we are looking forward to furthering the development of our clinical candidate. Having created the scientific basis of the company through many years of basic cancer research, we are of course very excited about this opportunity to take our results further towards clinical utilization, and we are very proud of having been selected for the Creation House program at BII".

Commenting on the ADCendo spin-out, Bo Porse, head of the Finsen Laboratory, notes: "At the Finsen Laboratory, we have a strong focus on the translational aspects, in addition to our basic research. The successful path of ADCendo from basic cancer research by its founders at the Finsen Laboratory, to a spin-out biotech, nicely illustrates how our research strategy may contribute to development of novel, innovative anti-cancer treatments".

ADCendo is, in parallel with furthering its ADCs, preparing pre-clinical and clinical development plans for metastatic soft tissue sarcoma (STS), a serious disease where patients have a median survival of only 12-18 months. Importantly, ADCendo aims to fill the gap following the drug Lartruvo (Olaratumab, an anti-PDGFR-α antibody), which was withdrawn from the STS market in early 2019 following a failed confirmatory phase III study. At launch, Lartruvo was the first new drug to be approved for first-line treatment of STS in 40 years, and the drug was well received and hoped to provide treatment for STS patients with substantial unmet needs. Going forward, ADCendo aims at developing its ADC strategy for STS, based on a development track similar to Lartruvo, which was granted orphan designation, fast track, breakthrough therapy designation, priority review status, and accelerated approval for STS, enabling a faster and more cost-effective clinical development path.

Henrik Stage, CEO of ADCendo explains: "In short, ADCendo’s business strategy is aimed at moving its lead compound into the clinic for STS patients, preferably based on an orphan drug designation, and hopefully receiving conditional approval for the drug to fill the gap after Lartruvo. Having been accepted for the BII program and receiving the convertible loan funding is an important step towards maturing the company, and preparing for the additional investments needed from investors and partners, to enable us to fulfil our ambitions of bringing our novel ADC drug to the market for treatment of patients with an unmet medical need".

Commenting on ADCendo’s acceptance for the BII program, Hervør Lykke Olsen, Senior Scientific Business Developer at BioInnovation Institute, says: "The goal for ADCendo is to develop a new drug for soft tissue sarcoma (STS), which is a heterogenous groups of tumors notorious for their recurrence, overall complexity, and difficulty to treat. Research from the ADCendo team has shown that the novel target, uPARAP, is highly overexpressed on the surface of cancer cells of STS tumors, making it very well suited for targeting with ADCendo’s ADCs. BII’s support on funding and business development can boost ADCendo to succeed in commercialization of the treatment to benefit patients".