On March 22, 2019 WuXi AppTec Co., Ltd. (stock code: 603259.SH / 02359.HK), a leading global pharmaceutical and medical device open-access capability and technology platform company with global operations, reported its audited annual results for the year ended December 31, 2018 today (Press release, WuXi AppTec, MAR 22, 2019, View Source [SID1234534573]).

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All financials disclosed in this press release are prepared based on International Financial Reporting Standards (or "IFRS").

Financial Highlights

Strong revenue growth of 23.8% year-over-year to RMB9,614 million. Applying a constant exchange rate, revenue grew 25.4% to RMB9,739 million. We continued to enhance capabilities and build capacity across all segments, while investing in the latest technologies to expand our service offering. We particularly benefited from a surging increase in business from China-based customers, and biotech customers globally.
Gross profit grew 16.6% year-over-year to RMB3,777 million. Gross profit margin was 39.3%.[1] Excluding the impact of foreign exchange loss, gross profit margin was 39.9%.
Net profit attributable to owners of the Company increased 84.2% year-over-year to RMB2,261 million, due to strong operations execution coupled with an extraordinary gain of RMB616 million from the fair value change of our investment portfolio.
Adjusted non-IFRS net profit attributable to owners of the Company grew 23.3% year-over-year to RMB1,742 million.
Diluted EPS and adjusted non-IFRS EPS increased by 70.0% and 13.9%, respectively.
Operational Highlights

We acquired 1,400+ new customers, and our active customers count reached 3,500+. – All of the top 20 global pharmaceutical companies are our customers. – We achieved 100% retention rate for our top 10 customers. – We continue to expand our biotech customer base rapidly as our integrated R&D platform enables them to efficiently and effectively discover and develop products.
For our success-based drug discovery services, in 2018 we filed 27 new-chemical-entity INDs for our customers with the NMPA (China National Medical Products Administration) and obtained 17 CTAs (clinical trial approval). As of December 31, 2018, we have cumulatively submitted 55 new-chemical-entity IND filings with NMPA for our customers and obtained 34 CTAs.
Our small molecule CDMO/CMO segment provided services to 650+ projects, including 40 in Phase III clinical trials and 16 that have been commercialized.
We became the first CMO services provider under China’s newly implemented MAH (Market Authorization Holder) policy and began commercial manufacturing services for two products, including: Ganovo, developed by Ascletis Pharma for treatment of Hepatitis C and Elunate, developed by Hutchison MediPharma for treatment of colorectal cancer.
In the highly-specialized field of cell and gene therapy, we provided CDMO services for 30 clinical stage cell and gene therapies projects; 25 in phase I and 5 in phase II/III.
Our fast growing clinical research services business helped one multinational company’s PD-1 antibody obtain market approval in China. We also helped a domestic company’s break-through drug obtain market approval for the treatment of colorectal cancer. In addition, we helped the BLA submission of the first CD20 biosimilar product in China.
In July 2018, we acquired an Austin, Texas based clinical research CRO WuXi Clinical Development, Inc. (carrying on business as ResearchPoint Global). This acquisition has allowed us to expand our global clinical trial service offering to both China based companies and US based companies for their global clinical development.
To support future growth, we are significantly expanding capacity including: chemistry laboratory expansion in our Tianjin site and new Qidong site; new cell and gene therapy GMP facilities in our Philadelphia site and Wuxi Jiangsu site; API GMP manufacturing facilities in our Changzhou site; a new medical device testing laboratory in Suzhou, and a new biology research laboratory in San Diego, California.
Management Comments

"2018 was an incredible year for the global healthcare industry and a fantastic one for our company," said Dr. Ge Li, Chairman and CEO. "The industry experienced significant progress as new innovative drugs address increasingly complex indications with remarkable results. And with the drug approval timeline greatly accelerated, the number of new drugs approved for market in the United States and in China has reached a record high. We were proud to see that 39 out of the 59 new drugs approved by the FDA came from our customers and we are committed to continually investing in our capabilities and capacity to consistently provide the highest level of service in this rapidly-changing environment."

"We are grateful to our investors who continue to believe in our vision. The capital they provide drives our growth reinforcing the confidence they have in our management team and our business model. In May and December of 2018, we successfully listed on the Shanghai Stock Exchange and the Main Board of the Hong Kong Stock Exchange, respectively."

"Our ‘Follow the Project / Follow the Molecule / Follow the Customer’ strategy continues to deliver stellar results. All along, we continued to successfully execute on our business plan achieving revenue of RMB9,614 million, representing growth of 23.8% year-over-year. Applying a constant exchange rate, our revenue grew 25.4% to RMB9,739 million. Revenue growth was broad-based across all business segments; especially our China-based laboratory services, CDMO/CMO services and clinical research and other CRO services. In addition to investments in our operations, i.e. new talent, new laboratories and facilities, our unique ecosystem that we are relentlessly building provided additional opportunities for us to effectively put our capital to use laying the foundation for future growth."

"WuXi AppTec is committed to enable innovation worldwide, catalyzing and benefiting from the continuous transformation of the healthcare ecosystem," Dr. Li continued. "Once the platform boasts enough scale and depth, the long tail effects will be truly dramatic. Looking forward, we are now entering an unprecedented golden age with the healthcare ecosystem emerging, where an ever-increasing number of participants are able to play a role at different stages of innovation. Through our integrated platform, more and more institutions, scientists, hospitals, and doctors will realize their dreams of innovation. In doing so, we will undoubtedly help bring vital medicine to patients faster."

Full-Year 2018 IFRS Results

2018 revenue increased 23.8% year-over-year to RMB9,614 million. Applying a constant exchange rate, revenue increased 25.4% year-over-year to RMB9,739 million. – Our China-based laboratory services revenue increased 24.1% year-over-year to RMB5,113 million. We fully leveraged our platform to attract more customers, especially "long-tail" customers, while expanding services to our existing customers. – We grew our CDMO/CMO services revenue 28.0% year-over-year to RMB2,699 million by diligently executing our "follow the molecule" strategy. As our customers’ projects move into late stage, we progress alongside of them by providing process validation services all the way through to commercial manufacturing services. – Our US-based laboratory services revenue increased 6.1% year-over-year to RMB1,204 million. Revenue growth was driven by our cell and gene therapies CDMO services and partially offset by a decline in medical device testing services. Cell and gene therapies CDMO services revenue grew 7.5% and 28.4% in the first half of 2018 and second half of 2018, respectively. – Our clinical research and other CRO services revenue increased 64.2% year-over-year to RMB585 million. Revenue growth was mainly driven by the substantial increase of the domestic drug clinical trial market as well as significant improvement of our services in terms of quality, scale and capabilities. – Across all segments, we benefitted from the rapid rise of pharmaceutical innovation in China experiencing 55.5% year-over-year revenue growth from China-based customers.
2018 gross profit increased 16.6% year-over-year to RMB3,777 million. Gross profit margin was 39.3%, slightly lower than 41.7% in 2017[2] primarily due to a decrease in gross profit of US-based laboratory services and RMB appreciation against USD in the first half of 2018. Applying a constant exchange rate, the gross profit margin would be 39.9%.
2018 IFRS net profit attributable to owners of the Company increased 84.2% year-over-year to RMB2,261 million. We experienced significant synergies across business segments by fully leveraging the strength of our "integrated end-to-end" R&D services platform. In addition, we experienced an extraordinary gain of RMB616 million from the fair value change of our investment portfolio.
Full-Year 2018 Non-IFRS Results

2018 non-IFRS net profit attributable to owners of the Company increased 75.5% year-over-year to RMB2,464 million. This excludes RMB46 million share-based payments, RMB22 million listing expenses for the offering of our A shares and H shares, RMB116 million foreign exchange-related losses and RMB19 million amortization of intangible assets acquired.
Full-Year 2018 Adjusted Non-IFRS Results

Excluding a further RMB750 million realized and unrealized gains from our venture investments and RMB28 million losses from our joint ventures, 2018 adjusted non-IFRS net profit attributable to owners of the Company increased 23.3% year-over-year to RMB1,742 million in 2018.
[1] If prepared under Accounting Standard for Business Enterprises of PRC, the gross profit grew 16.8% year over year to RMB 3,793 million. Gross profit margin was 39.5%.

[2] If prepared under Accounting Standard for Business Enterprises of PRC, 2018 gross profit increased 16.8% year-over-year to RMB 3,793 million. Gross profit margin was 39.5%, slightly lower than 41.8% in 2017.

On March 21, 2019 Cofactor Genomics reported that Natalie LaFranzo, the company’s Director of Scientific Projects and Market Development, reported that it will present at the 2019 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) being held at the Georgia World Congress Center in Atlanta, GA (Press release, Cofactor Genomics, MAR 21, 2019, View Source [SID1234534535]). The presentation is scheduled to take place on Sunday, March 31, 2019, at in Session PO.TB06.04 – Gene Expression in the Tumor Microenvironment. The presentation features Predictive Immune Modeling and multidimensional biomarker data generated in collaboration with TriStar Technology Group, a leading provider of archived human bio specimens and related research services offering highly-characterized and well-curated donor samples with extensive clinical follow-up data.

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Executives from the company including CEO, Jarret Glasscock, will be attending the meeting to engage with current and future collaborators, clients, and investors. Visit View Source to arrange a time to meet with executives from Cofactor. The company also continues to solicit applications for their ImmunoPrism Grant Program, closing April 15. The grant program offers researchers the first opportunity to access Cofactor’s Predictive Immune Modeling platform. More information on the grant program may be found here: View Source

On March 21, 2019 Unum Therapeutics Inc. (Nasdaq: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies to treat cancer using its novel T cell technology platforms, reported that the company will host a conference call and live audio webcast on Thursday, March 28, 2019 at 8:00 a.m. ET to discuss financial results for the fourth quarter and full year of 2018 (Press release, Unum Therapeutics, MAR 21, 2019, View Sourcenews-releases/news-release-details/unum-therapeutics-host-fourth-quarter-and-full-year-2018" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-host-fourth-quarter-and-full-year-2018" rel="nofollow">View Source [SID1234534521]). Unum management will also provide an update on the Company’s recent progress and upcoming milestones.

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Participants may access the conference call by dialing 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 8169027. To join the live webcast, please visit the investor relations section of the Unum Therapeutics website at View Source at least 10 minutes before the event begins.

A webcast replay will be available at the same location on the Unum Therapeutics website beginning approximately two hours after the event and will be archived for 90 days.

On March 21, 2019 City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, reported that it will showcase ongoing studies and data on chimeric antigen receptor (CAR) T cell therapy, immunotherapy against solid tumors and more at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting from March 29 through April 3 in Atlanta (Press release, City of Hope, MAR 21, 2019, View Source [SID1234534536]).

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"We hope to move enhanced T cell therapy forward in solid tumors, especially in lung cancers."

More than 22,500 scientists, advocates and clinicians from around the globe are expected to attend the 2019 AACR (Free AACR Whitepaper) meeting at the Georgia World Congress Center to discuss the latest advances in immunotherapy, artificial intelligence, targeted therapy, liquid biopsy, science policy and cancer health disparities.

"City of Hope’s physicians and scientists will share their discoveries and leading-edge expertise with colleagues in the cancer field," said Michael Caligiuri, Deana and Steve Campbell Physician-in-Chief Distinguished Chair, president of City of Hope National Medical Center and former AACR (Free AACR Whitepaper) president.

Highlights of City of Hope’s significant contribution to discovering breakthroughs in cancer diagnosis, prevention and treatment include the following:

The immunotherapy arsenal: Ecology of the tumor microenvironment in breast cancer

Monday, April 1, from 3 to 5 p.m. in Room A311

To destroy a tumor, physicians shouldn’t just target the cancer cells, said Peter P. Lee, M.D., Billy and Audrey L. Wilder Professor in Cancer Immunotherapeutics at City of Hope. Doctors should also develop treatments that target or alter the tumor microenvironment. "Think of the tumor microenvironment as an ecosystem or a game of Jenga," Lee said. "The building blocks of a tumor comprise not just cancer cells, but also support (stromal) cells, immune cells, as well as an extracellular matrix. If you target any of the critical building blocks that support the cancer cells, you would still be able to get the tumor ecosystem to collapse."

For the past three years, Lee has led a convergent science team to study the Ecology of the Tumor Microenvironment in Breast Cancer through the support of Stand Up to Cancer. His team of biomedical scientists, physician-scientists, physicists, mathematicians and computer scientists has generated petabytes of data about the impact of the spatial interplay between components of the tumor microenvironment on disease progression. They have published papers in Nature Communications and the Proceedings of the National Academy of Sciences (PNAS); they are currently working on several additional manuscripts.

How population differences and environmental exposures affect tumor biology

Tuesday, April 2, from 10:30 a.m. to 12:30 p.m. in Room B206

Scientists are beginning to learn how environmental exposures like culture and individual life choices influence the biology of tumors and specific cell mechanisms. Research shows that more aggressive tumors with worse prognoses are sometimes the result of population differences and increased exposure to disease risk factors. Rick A. Kittles, Ph.D., associate director of Health Equities at City of Hope’s comprehensive cancer center, will discuss an ongoing study that looks at the role of vitamin D in prostate cancer. He will elaborate on how vitamin D intake can serve as a biomarker for prostate cancer risk. Victoria L. Seewaldt, M.D., Ruth Ziegler Chair in Population Sciences at City of Hope, will discuss breast cancer and how health disparities can result in obesity and inflammation, both of which improve the chance of incurring aggressive tumors in the breast.

How global health research advances cancer health equity in the U.S.

Friday, March 29, from 3 to 6 p.m. at Morehouse School of Medicine

Rick A. Kittles, Ph.D., director of the Division of Health Equities at City of Hope, and other scientists will discuss how global efforts to eliminate cancer contributes to the advancement of cancer health equity in the United States. Kittles will explore the impact different environments have on genes. In particular, he will talk about the African diaspora, which moved millions of people from western and central Africa to the Americas and the Caribbean. Genetically, these individuals are not very different, but different environmental and social experiences across the lifespan resulted in varied disease susceptibility and health outcomes.

Natural killer cells

Wednesday, April 3, from 7 to 8 a.m. in Room A311

Michael Caligiuri, M.D., president of City of Hope National Medical Center and former AACR (Free AACR Whitepaper) president, will detail natural killer cells and the findings his scientific teams have made in the past 25-plus years in this field. His research in natural killer cells and other topics led the AACR (Free AACR Whitepaper) Academy to induct Caligiuri as a fellow last year to recognize his significant scientific contributions that have propelled consequential innovation and progress against cancer.

The protein CD27+ may mark just how effective CAR T cell products are

Monday, April 1, from 1 to 5 p.m.

City of Hope researchers continue to make headway in developing more efficient CAR T cell treatments and are using a new preclinical study finding to try to refine its ongoing clinical trial of CAR T cell therapy against glioblastomas. Dongrui Wang, a Ph.D. candidate at the institution, Christine Brown, Ph.D., Heritage Provider Network in Immunotheraphy and associate director of the T Cell Therapeutics Research Laboratory at City of Hope, and others found that the immune T cell surface protein CD27 makes CAR T cells better tumor killers through interaction within its signaling molecule CD70. Specifically, CAR T cells enriched for CD27+ cells exhibited enhanced memory function and were able to perform their antitumor activity longer both in vitro and in vivo. "This study is a big step toward refining our CAR T cell manufacturing processes: We should preserve the CD27+ population to magnify the immunotherapy’s therapeutic applications," Wang said. "Our study also suggests that CD27+ can be used as a biomarker to predict how effective and potent an immunotherapy will be in specific patients in City of Hope’s clinical trials."

The glioblastoma clinical trial Wang referenced earlier opened in 2015 and is a part of the California Institute for Regenerative Medicine-sponsored Alpha Stem Cell Clinic at City of Hope.

Poster session title: 2321 / 20: Dual-function of CD27-CD70 costimulatory signal in CAR T cell therapy

Combining engineered autologous T cells with enhanced T cell receptors in combination with a monoclonal antibody to treat solid tumors in advanced lung cancer

Tuesday, April 2, from 1 to 5 p.m.

Leading the path into the next stage of immunotherapy, City of Hope is enrolling patients in an autologous T cell clinical trial that aims to re-engineer and use a patient’s own immune T cells to attack solid tumors in their body. Enhanced T cell therapy has been successful in treating hematologic (blood) cancers and is in early development for solid tumors.

The randomized 1a/2b study will investigate the safety and efficacy of enhancing a patient’s own T cells with NY-ESO-1/LAGE-1a antigens so that their immune system will better attack advanced nonsmall cell lung cancer. The therapy, of course, can be used only in people whose tumors express the NY-ESO-1 and/or LAGE-1a receptors.

Today’s standard of care for advanced non-small cell lung cancer leads to long-term benefits for about 10 percent of patients, said Karen Reckamp, M.D., M.S., co-director of the Lung Cancer and Thoracic Oncology Program at City of Hope and principal investigator of the ongoing clinical trial. The majority of patients with this disease have few treatment options. "T cell therapy is a high priority for City of Hope," Reckamp said. "We hope to move enhanced T cell therapy forward in solid tumors, especially in lung cancers."

In the ongoing clinical trial, the patient’s engineered T cells, called GSK3377794, will be used alone and in combination with pembrolizumab, a monocolonal antibody that blocks PD-1/PD-L1 interaction and increases the antitumor function of T cells. The synergistic treatment potentially can help certain patients with Stage 3 or Stage 4 nonsmall cell lung cancer – people who have tried other treatments but have not been able to find their way back to health.

The study is a part of the California Institute for Regenerative Medicine-sponsored Alpha Stem Cell Clinic at City of Hope. It is supported by GlaxoSmithKline and is a collaboration with Merck & Co., Inc.

Poster session title: CT225 / 19: A Phase 1b/2a randomized pilot study to investigate the safety and tolerability of autologous T cells with enhanced T cell receptors specific to NY-ESO-1L/LAGE-1a (GSK3388894) alone, or in combination with pembrolizumab, in advanced non-small cell lung cancer

Moving diagnostic technology into today’s world using artificial intelligence and 3D imaging

Monday, April 1, from 8 a.m. to noon

City of Hope and its affiliate Translational Genomics Research Institute (TGen) is collaborating with others to create the future of oncologic radiology – what City of Hope’s Syed Rahmanuddin, M.B.B.S., calls "the mammogram of pancreatic cancers." His team is using top-of-the-line technology to create artificial intelligence algorithms that compile a detailed 3D image of pancreatic cancer. The purpose is to enable physicians to identify the volume of blood flow (perfusion kinetics) of tumors and learn how effective a treatment is, facilitating adjustments to regimens to allow for improved targeted cancer therapy. Right now, the standard of care is flat, black-and-white multiphase computed tomography (CT) imaging. "Our new, patient-centered 3D imaging approach is like the transition from thinking the world is flat to understanding that the world is a globe: It opens up a whole world of possibility," Rahmanuddin said. "Our pilot study suggests that change in 3D volume and perfusion (blood flow) are important imaging markers that correlate with tumor progression, regression and aggression, which could be very helpful for the early detection of pancreatic cancer."

Daniel Von Hoff, M.D., physician-in-chief and distinguished professor of TGen, and Ronald Korn, M.D., Ph.D., of Imaging Endpoints were key contributors to this research.

Poster session title: 1622 / 20: Role of 3d volumetric and perfusion imaging for detecting early changes in pancreatic adenocarcinoma

Molecule found in orange peel slows down breast cancer tumor growth in mouse models

Wednesday, April 3, from 8 a.m. to noon

A molecule found on the skin of citrus fruits appears to inhibit the growth of breast cancer tumors in a mouse model. Compared to control mice with xenografted breast cancer cells, those who received 2’-Hydroxyflavanone (2HF) experienced reduced viability and proliferation of breast cancer cells. In addition, 2HF inhibited the expression of RLIP, a protein that is overexpressed in breast cancer cells. "While more research is needed to see if what we found in our mouse models can be translated to human subjects, it is important to note that natural compounds extracted from, say, orange peels is not toxic and has been shown to be beneficial, including lowering glucose triglycerides and cholesterol levels," said Sharad Singhal, Ph.D., lead author of the study and research professor in medical oncology at City of Hope. "In the distant future, it’s possible that 2HF supplements can be taken by breast cancer patients to enhance the effectiveness of medical treatment."

Poster session title: 4801 / 15: 2’-Hydroxyflavanone, a diet-derived citrus bioflavonoid, inhibits in vitro and in vivo growth of breast cancer cells by targeting RLIP.

On March 21, 2019 In an article published today by SAGE Publishing, investigators from The Nagourney Cancer Institute and The Albert Einstein Israelite Hospital in São Paulo, Brazil, reported a new approach to identifying effective treatments for patients with advanced metastatic cancers (Press release, Nagourney Cancer Institute, MAR 21, 2019, View Source [SID1234534558]). A drug commonly used to treat kidney and liver cancer was discovered effective for breast cancer, which may open new drug therapies to patients regardless of tumor type. The full article can be found at View Source

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The study reports the use of 3-dimensional-human-tumor derived organoids that were isolated directly from a patient’s drug resistant breast cancer. The drug identified, sorafenib (Nexavar), is widely used for the treatment of kidney and liver cancers but has not been found active, used, nor approved for patients with breast cancer.

"The finding of sorafenib activity was unexpected," said Dr. Robert Nagourney, one of the authors of the paper and the director for the laboratory where the studies were conducted.

When the patient with disease that had spread throughout her body had a near complete remission with only two months of oral therapy, a remission that lasted for over a year, the researchers examined possible mechanism for the response and believe that it reflects an entirely new form of cancer cell death known as "ferroptosis." This iron-mediated process of cancer cell death is uniquely activated by sorafenib.

"Of the many targeted drugs that we tested on the cancer cells from a woman who had few options remaining, it was only sorafenib that had this effect, prompting our colleagues in São Paulo to begin therapy immediately," said Dr. Nagourney. "We are fortunate to have fantastic collaborators in Brazil who tested this therapy to such good effect."

The results could not have been more dramatic as the patient showed compete metabolic response by PET/CT only weeks later.

"We are witness to a new concept in cancer medicine where drugs can be identified and selected for individual patients in the laboratory regardless of the tumor type, that is, breast versus kidney versus lung. Drugs do not know what disease for which they were invented," he added.

The drug selection technique employed by Dr. Nagourney was developed by scientists in his laboratory in California. It uses fresh biopsies removed directly from patients to study each cancer patient’s biology to select from amongst dozens of drugs and combinations, those that will work the best. This is but one more example of what is known as repurposing drugs, allowing physicians to outsmart cancers by going around their defenses.

"It is the availability of the EVA/PCD testing platform that for this first time is making it possible to make rational drug choices for cancer patients based upon each individual’s unique features," Nagourney concluded.