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Provectus Announces Acceptance of PV-10® Liver Cancer Abstracts at American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program

On April 29, 2020 Provectus (OTCQB: PVCT) reported that abstracts about and data from our clinical trials of investigational autolytic cancer immunotherapy PV-10 (rose bengal disodium) as a single-agent for the treatment of neuroendocrine tumors metastatic to the liver (NCT02693067) and in combination with immune checkpoint blockade for the treatment of uveal melanoma metastatic to the liver (NCT00986661) were accepted for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program, to be held May 29-31, 2020 online (Press release, Provectus Pharmaceuticals, APR 29, 2020, View Source [SID1234556851]).

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Small molecule-based PV-10 is administered by percutaneous intratumoral injection to primary or metastatic tumors of the liver, such as hepatocellular carcinoma, metastatic colorectal cancer, metastatic neuroendocrine tumors, and metastatic uveal melanoma. By targeting tumor cell lysosomes, PV-10 treatment may yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells.1-4

Abstract #1:

Title: Percutaneous hepatic injection of rose bengal disodium (PV-10) in metastatic uveal melanoma
Poster session: Developmental Therapeutics – Immunotherapy
Abstract number for publication: 3143
Abstract #2:

Title: Cohort 1 results of a phase I study of autolytic immunotherapy of metastatic neuroendocrine neoplasms using intralesional rose bengal disodium
Abstract number for publication: e16694
About PV-10

PV-10 is an investigational new drug undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver (including metastatic neuroendocrine tumors and metastatic uveal melanoma). PV-10 is also undergoing preclinical study for pediatric solid tumor cancers (like neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma) and pediatric blood cancers (like leukemia).5,6

Tumor Cell Lysosomes as the Seminal Drug Target

Lysosomes are the central organelles for intracellular degradation of biological materials, and nearly all types of eukaryotic cells have them. Discovered by Christian de Duve, MD in 1955, lysosomes are linked to several biological processes, including cell death and immune response. In 1959, de Duve described them as ‘suicide bags’ because their rupture causes cell death and tissue autolysis. He was awarded the Nobel Prize in 1974 for discovering and characterizing lysosomes, which are also linked to each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Building on the Discovery, Exploration, and Characterization of Lysosomes

Cancer cells, particularly advanced cancer cells, are very dependent on effective lysosomal functioning.7 Cancer progression and metastasis are associated with lysosomal compartment changes8,9, which are closely correlated with (among other things) invasive growth, angiogenesis, and drug resistance10.

PV-10 selectively accumulates in the lysosomes of cancer cells upon contact, disrupting the lysosomes and causing the cells to die. Provectus1,11, external collaborators6, and other researchers13,14,16 have independently shown that PV-10 (RB) triggers each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Cancer Cell Autolytic Death via PV-10: PV-10 induced autolytic cell death, or death by self-digestion, in Hepa1-6 murine HCC cells can be viewed in this Provectus video of the event (ethidium homodimer 1 [ED-1] stains DNA, but is excluded from intact nuclei; lysosensor green [LSG] stains intact lysosomes; the video is provided in 30-second frames; the event has a duration of approximately one hour). Exposure to PV-10 triggers the disruption of lysosomes, followed by nucleus failure and autolytic cell death. Identical responses have been shown by the Company in HTB-133 human breast carcinoma (which can be viewed in this Provectus video; this event has a duration of approximately two hours) and H69Ar human multidrug-resistant small cell lung carcinoma. Cancer cell autolytic cell death was reproduced by research collaborators from POETIC using relapsed and refractory human pediatric neuroblastoma cells to show that lysosomes are disrupted upon exposure to PV-10.5

Immune Signaling Pathways: PV-10 causes acute autolytic destruction of injected tumors (i.e., cell death), mediating several identified immune signaling pathways studied to date, such as the release of danger-associated molecular pattern molecules (DAMPs) and tumor antigens that initiate an immunologic cascade where local response by the innate immune system facilitates systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. Other mediated immune signaling pathways that have been identified include poly-ADP ribose polymerase (PARP) cleavage5 and, now, stimulator of interferon genes (STING), which plays an important role in innate immunity15. PV-10 is the first cancer drug that may facilitate multiple, complementary, immune system signaling pathways.16

Orphan Drug Designations (ODDs)

ODD status has been granted to PV-10 by the U.S. Food and Drug Administration for the treatments of metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

Drug Product

Rose bengal disodium (RB) (4,5,6,7-tetrachloro-2’,4’,5’,7’-tetraiodofluorescein disodium salt) is a small molecule halogenated xanthene and PV-10’s active pharmaceutical ingredient. PV-10 drug product is a formulation of 10% w/v RB in 0.9% saline, supplied in single-use glass vials containing 5 mL (to deliver) of solution, and administered without dilution to solid tumors via intratumoral injection.

Intellectual Property (IP)

Provectus’ IP includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the process by which pharmaceutical grade RB and related halogenated xanthenes are produced, reducing the formation of previously unknown impurities that exist in commercial grade RB in uncontrolled amounts. The requirement to control these impurities is in accordance with International Council on Harmonisation (ICH) guidelines for the manufacturing of an injectable pharmaceutical. US patent numbers are 8,530,675, 9,273,022, and 9,422,260, with expirations ranging from 2030 to 2031.

The Company’s IP also includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the combination of PV-10 and systemic immunomodulatory therapy (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers. US patent numbers are 9,107,887, 9,808,524, 9,839,688, and 10,471,144, with expirations ranging from 2032 to 2035.

Entry into a Material Definitive Agreement

On April 29, 2020, PTC Therapeutics, Inc. (the "Company"), reported that certain of the former equityholders of Agilis Biotherapeutics, Inc. ("Agilis"), and, for the limited purposes set forth in the agreement, Shareholder Representative Services LLC, entered into a Rights Exchange Agreement (the "Rights Exchange Agreement"), pursuant to which the Company agreed to issue 2,821,176 shares of its common stock (the "Common Stock Consideration") and paid $36,881,009 (the "Cash Consideration"), in the aggregate, to such former equityholders of Agilis (the "Participating Rightholders") in exchange for the cancellation and forfeiture by the Participating Rightholders of their rights to receive certain milestone-based contingent payments under the Agreement and Plan of Merger (the "Merger Agreement") by and among the Company, Agility Merger Sub, Inc., Agilis, and, solely in its capacity as the representative, agent and attorney-in-fact of the equityholders of Agilis, Shareholder Representative Services LLC, dated as of July 19, 2018, pursuant to which the Company acquired Agilis in 2018 (the "Acquisition") (Filing, 8-K, PTC Therapeutics, APR 29, 2020, View Source [SID1234556842]). Also on April 29, 2020, the Company issued 2,723,826 shares of the Common Stock Consideration to certain of the Participating Rightholders pursuant to the Rights Exchange Agreement, with the issuance of the remaining 97,350 shares of the Common Stock Consideration to certain of the Participating Rightholders who are former employees of Agilis or current or former employees of the Company to be deferred until the earlier of (i) December 15, 2020 or (ii) the date on which the Company files a registration statement on Form S-3 with respect to the resale of the shares of the Common Stock Consideration pursuant to the terms of the Rights Exchange Agreement, as further described below.
Pursuant to the terms of the Rights Exchange Agreement, the Participating Rightholders have canceled and forfeited their rights under the Merger Agreement to receive (i) $174.0 million, in the aggregate, of potential milestone payments based on the achievement of certain regulatory milestones and (ii) $37.6 million, in the aggregate, of $40.0 million in development milestone payments due upon the passing of the second anniversary of the closing of the Acquisition, regardless of whether the milestones are achieved.
The Rights Exchange Agreement has no effect on the Merger Agreement other than to provide for the cancellation and forfeiture of the Participating Rightholders’ rights to receive $211.6 million, in the aggregate, of the milestone payments described above. As a result, all other rights and obligations under the Merger Agreement remain in effect pursuant to their terms, including the Company’s obligation to pay up to an aggregate maximum amount of $22.4 million upon the achievement of certain development milestones (representing the remaining portion of potential development milestone payments after deducting the $37.6 million for which rights were canceled and forfeited pursuant to the Rights Exchange Agreement from the $40.0 million in development milestone payments that are due upon the passing of the second anniversary of the closing of the Acquisition), up to an aggregate maximum amount of $361.0 million upon the achievement of certain regulatory milestones (representing the remaining portion of potential regulatory milestone payments for which rights were not canceled and forfeited pursuant to the Rights Exchange Agreement), up to a maximum aggregate amount of $150.0 million upon the achievement of certain net sales milestones and a percentage of annual net sales for Friedreich ataxia and Angelman syndrome during specified terms, ranging from 2% to 6%, pursuant to the terms of the Merger Agreement.
Pursuant to the Rights Exchange Agreement, the Company has agreed to use commercially reasonable efforts to file as promptly as practicable after the date of the Rights Exchange Agreement, but in no event earlier than the date on which the Company files a Quarterly Report on Form 10-Q following the date of the Rights Exchange Agreement, a registration statement on Form S-3 with respect to the resale of the shares of the Common Stock Consideration issued to the Participating Rightholders pursuant to the Rights Exchange Agreement and to maintain the effectiveness of such registration statement until the six-month anniversary date of the Rights Exchange Agreement or such earlier time as all shares of the Common Stock Consideration covered by the registration statement have been sold, subject to certain exceptions and the provision of certain information by the Participating Rightholders. The Rights Exchange Agreement contains customary indemnification obligations of the Company and the former Agilis equityholders with respect to the registration statement.

resTORbio and Adicet Bio Announce Merger Agreement to Advance Allogeneic Gamma Delta CAR-T Cell Therapy Technology

On April 29, 2020 resTORbio, Inc. (Nasdaq: TORC) and Adicet Bio, Inc., a privately-held biopharmaceutical company, reported that they have entered into a definitive merger agreement to create a combined publicly-traded biotechnology company focused on the development of Adicet’s off-the-shelf allogeneic gamma delta T cell therapies for oncology and other indications (Press release, ResTORbio, APR 29, 2020, View Source [SID1234556818]). Adicet’s lead candidate, ADI-001, is a gamma delta CAR-T cell therapy targeting CD20 being developed for non-Hodgkin’s lymphoma. Adicet has a pipeline of differentiated pre-clinical and discovery programs leveraging its universal, off-the-shelf gamma delta CAR-T cell platform.

Under the terms of the agreement, Adicet would merge with a wholly-owned subsidiary of resTORbio in an all-stock transaction, and the equityholders of Adicet will become the majority owners (75%) of resTORbio’s outstanding common stock upon the close of the merger.

"After a thorough evaluation of strategic alternatives, the Board of Directors of resTORbio believes that this merger represents the highest-potential value creation opportunity for resTORbio stockholders," commented Chen Schor, Co-Founder, President and Chief Executive Officer of resTORbio, Inc. "The combined company will leverage Adicet’s scientific and product development expertise and pipeline of engineered immune cell therapeutics for cancer based on its proprietary gamma delta T cell therapy platform. We believe this transformative transaction will provide the resources for the combined company to advance multiple programs into the clinic, including Adicet’s lead candidate, ADI-001, a gamma delta CAR-T cell therapy targeting CD20, and expand the pipeline in oncology and other indications."

"Adicet believes that its novel and highly productive efforts to date have generated a compelling allogeneic cell therapy platform that overcomes key challenges faced by existing CAR-T therapy," said Anil Singhal, Ph.D. President and Chief Executive Officer of Adicet Bio, Inc. "The proposed merger with resTORbio is the right next step in our trajectory, and we expect that it will provide Adicet with the resources to rapidly accelerate the development of its unique product candidates based on this platform and leverage our cGMP manufacturing process to create best-in-class therapies for patients in need."

Adicet completed an $80 million Series B financing in October 2019 and was backed by OrbiMed Advisors, aMoon2 Fund, Novartis Venture Fund, Regeneron Pharmaceuticals, Inc., Johnson & Johnson Innovation – JJDC, Inc. (JJDC), OCI Enterprises, Inc, KB Investment Co., Ltd., Consensus Business Group, SBI JI Innovation Fund, Samsung Venture Investment Corporation, Handok, Inc., DSC Investment, Inc. and Pontifax.

In August 2016, Adicet entered into a strategic collaboration with Regeneron focused on developing next-generation engineered immune cell therapeutics using Adicet’s gamma delta T cell allogeneic platform technology.

In addition to its gamma delta T cell therapy platform, Adicet also identifies and validates cancer specific targets derived from the intracellular proteome and then generates T cell receptor-like monoclonal antibodies (TCRLs) directed to these cancer-specific peptide targets presented by major histocompatibility complex (MHC) Class I complexes. These TCRLs are designed to arm CAR-modified T cells or as T cell engaging antibodies that target solid tumors.

About the Proposed Merger
Under the terms of the merger agreement, stockholders of Adicet will receive shares of newly issued resTORbio common stock. On a pro forma basis, Adicet equityholders are expected to own approximately 75% of the combined company and current resTORbio equityholders are expected to own approximately 25% of the combined company. The parties anticipate that the combined company’s primary focus will be to advance Adicet’s unique cell therapy platform. The parties anticipate that the combined company will continue the development of RTB101, resTORbio’s small molecule product candidate that is a potent inhibitor of target of rapamycin complex 1 (TORC1), for a COVID-19 related indication, with clinical data expected by Q1 2021. The terms of the merger agreement contemplate that a contingent value right (a "CVR") will be distributed to resTORbio stockholders as of immediately prior to the effective time of the merger, entitling CVR holders to receive net proceeds from the commercialization, if any, received from a third party commercial partner of the product candidate RTB101. The terms and conditions of the CVRs will be pursuant to a CVR Agreement resTORbio will enter into prior to the closing of the merger (the "CVR Agreement").

Following the merger, the combined company will leverage expertise from both companies with Chen Schor to serve as President and Chief Executive Officer, Stewart Abbot, Ph.D., as Senior Vice President and Chief Operating and Scientific Officer, Francesco Galimi, M.D., Ph.D., as Senior Vice President and Chief Medical Officer, Lloyd Klickstein, M.D., Ph.D., as Chief Innovation Officer, Carrie Krehlik, as Senior Vice President and Chief Human Resource Officer and Joan Mannick, M.D., as Head of Infectious Diseases to oversee the clinical program conducted under the CVR. At closing, the combined board of directors is anticipated to consist of seven members, which will include five designated from Adicet, one designated from resTORbio and Chen Schor, President and Chief Executive Officer. Anil Singhal will serve as an advisor to the board of directors. The company will maintain offices in Menlo Park, CA and Boston, MA.

"On behalf of the Adicet Board, we thank Anil for his service to Adicet and welcome his contributions as an advisor to the Board of Directors," said Carl Gordon, Ph.D., member of Adicet’s Board of Directors.

The transaction is expected to close in the second half of 2020, subject to approvals of each company’s stockholders and other customary closing conditions. Upon completion of the merger, the combined company will operate under the name Adicet Bio and is expected to trade on the Nasdaq Global Market under a new ticker symbol to be determined.

JMP Securities LLC is acting as financial advisor to resTORbio and Goodwin Procter LLP is serving as legal counsel to resTORbio. Morrison & Foerster LLP is serving as legal counsel to Adicet Bio.

E1912 trial leads to FDA approval of ibrutinib-rituximab combo for untreated CLL

On April 29, 2020 ECOG-ACRIN reported that Patients with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma now have a new treatment option—a combination of the targeted agent ibrutinib with the immunologic agent rituximab (Press release, ECOG-ACRIN, APR 29, 2020, View Source [SID1234556809]). The U.S. Food and Drug Administration (FDA) has approved the combination based on data from E1912, a phase 3 trial developed and led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN). The E1912 study showed that the ibrutinib-rituximab combination not only provided better leukemia control, it also prolonged life and had fewer side effects when compared with the standard chemotherapy/immunotherapy of fludarabine, cyclophosphamide, and rituximab (FCR). The E1912 trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. The importance of these findings is reinforced by the breadth of participation of academic and community institutions that together completed this innovative study.

peter odwyer"Elimination of chemotherapy from the initial therapy of these common forms of leukemia is a major step in the development of more specific treatments for cancer," said ECOG-ACRIN Group Co-Chair Peter J. O’Dwyer, MD (pictured at left), a medical oncologist at the University of Pennsylvania. "The E1912 trial emphasizes the advances for patients that are powered by Cooperative Group research."

CLL is one of the most common types of leukemia in adults. It typically occurs during or after middle age and rarely occurs in individuals under the age of 40. Ibrutinib (Imbruvica, Pharmacyclics, an AbbVie company/Janssen) is a Bruton’s tyrosine kinase (BTK) inhibitor that interferes with the survival of lymphocytic leukemia cells. Rituximab (Rituxan, Roche/Genentech, and generics) enhances the ability of the body’s immune system to destroy the cells. The FDA had previously approved ibrutinib as monotherapy, in combination with obinutuzumab, or in combination with bendamustine and rituximab (BR) for patients with CLL.

In addition to ECOG-ACRIN, the E1912 trial represents a collaboration with the Alliance for Clinical Trials in Oncology, NRG Oncology, and SWOG cooperative groups in the NCI’s National Clinical Trials Network. These groups participated in the design and conduct of the trial and supported the enrollment and treatment of the 529 patients.

mark-litzow"The E1912 study demonstrates the power of the National Clinical Trials Network to conduct practice-changing clinical trials that improve survival and lessen toxicity in patients with CLL, and will allow hematologists and oncologists to take advantage of the power of targeted agents and minimize the use of toxic chemotherapy," said ECOG-ACRIN Leukemia Committee Chair Mark R. Litzow, MD (pictured at left), a hematologist at the Mayo Clinic and senior investigator on the E1912 trial.

In December 2018, the results of the first interim analysis of E1912 were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting after the data and safety monitoring board overseeing the trial recommended the information be released immediately given its significance to public health. Lead investigator Tait D. Shanafelt, MD, of Stanford University (pictured at left) reported that the combination of ibrutinib plus rituximab was superior to standard treatment for patients age 70 and younger with previously untreated CLL.

This was the first time any BTK inhibitor, in this case, an ibrutinib-based treatment approach, had been compared with the most effective standard treatment for CLL patients.

The trial met its primary endpoint of an improvement in progression-free survival (the length of time patients live before their disease worsens). The combination also improved overall survival, the trial’s secondary endpoint. In general, patients in the ibrutinib-rituximab arm were less likely to experience serious side effects than those in the standard treatment arm.

The New England Journal of Medicine published final results in August 2019. Those results reported a two-thirds reduction in the risk of disease progression and less toxicity from therapy with ibrutinib plus rituximab compared to standard FCR.

Dr. Shanafelt presented results from an extended follow-up analysis of patients in E1912 at the ASH (Free ASH Whitepaper) annual meeting in December 2019. The analysis provided new safety and efficacy information on the patients in E1912 who completed six months of combined ibrutinib plus rituximab therapy and continued to receive ibrutinib alone for as long as it remained effective. The analysis, based on a median follow-up of 48 months, reported that 73% of patients in the ibrutinib plus rituximab treatment arm remained on ibrutinib. At the time of that report, the median time on treatment was 43 months (range of 0.2 to 61 months). The median time to progression or death after discontinuing ibrutinib was 23 months. Superior progression-free survival benefits were sustained for the ibrutinib plus rituximab arm compared to the FCR treatment arm (hazard ratio [HR]=0.39; 95 percent CI, 0.26-0.57; p<0.0001). Overall survival also continued to favor the ibrutinib plus rituximab arm (HR=0.34, 95 percent CI, 0.15-0.80; p=0.010).

The only pretreatment characteristic that predicted discontinuation of ibrutinib for a reason other than progression was the number and severity of health problems other than CLL.

WuXi AppTec Reports Solid First-Quarter 2020 Results

On April 29, 2020 WuXi AppTec Co., Ltd. (stock code: 603259.SH / 2359.HK), a company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients, reported its unaudited financial results for the First-Quarter 2020 ("Reporting Period") (Press release, WuXi AppTec, APR 29, 2020, View Source [SID1234556796]).

This document serves purely as a summary and is not intended to provide a complete representation of the relevant matters. For further information, please refer to the 2020 first quarterly report and relevant announcements published on the websites of the Shanghai Stock Exchange (www.sse.com.cn) and the Stock Exchange of Hong Kong (www.hkexnews.hk), and the designated media for dissemination of the relevant information. Investors are advised to exercise caution and be aware of the investment risks in dealing in the shares of the Company.

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

First-Quarter 2020 Financial Highlights

Revenue grew 15.1% year-over-year to RMB3,188 million, driven by solid growth of our China-based laboratory services and US-based laboratory services.
IFRS gross profit grew 3.9% year-over-year to RMB1,097 million. Gross profit margin was 34.4%, lower than the 38.1% achieved in the same period of 2019[2], mainly because of: (1) the COVID-19 impact on our Wuhan site and clinical research services business, and (2) an increase in share-based compensation expenses.
Non-IFRS gross profit grew 10.3% year-over-year to RMB1,224 million. Non-IFRS gross profit margin was 38.1% compared to 39.9% for the same period in 2019.
EBITDA grew 2.7% year-over-year to RMB746 million.
Adjusted EBITDA grew 22.1% year-over-year to RMB1,035 million.
IFRS net profit attributable to owners of the Company was down 21.6% year-over-year to RMB303 million. In First-Quarter 2020, we experienced a RMB105 million loss from the fair value change of our investment portfolio and a RMB84 million loss of equity pick up from our joint ventures and associates, primarily due to a decline in stock price as of March 31, 2020, of certain public companies in our investment portfolio. During the same period in 2019, we reported a RMB189 million loss from the fair value change of our investment portfolio and a RMB181 million gain of equity pick up from our joint ventures and associates.
Adjusted non-IFRS net profit attributable to owners of the Company grew 10.8% year-over-year to RMB576 million.
Adjusted diluted non-IFRS EPS increased by 9.4% to RMB0.35 versus the same period last year, while diluted EPS was down 25.0% to RMB0.18.[3]
[1] In the three months ended March 31, 2019 and three months ended March 31, 2020, we had a fully-diluted weighted average share count of 1,630 million and 1,638 million ordinary shares, respectively.

[2] If prepared under Accounting Standard for Business Enterprises of PRC, the gross profit grew 4.0% year-over-year to RMB1,098 million. Gross profit margin was 34.5%, lower than the 38.1% achieved during the same period in 2019.

[3] In the three months ended March 31, 2019 and three months ended March 31, 2020, we had a fully-diluted weighted average share count of 1,630 million and 1,638 million ordinary shares, respectively.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "We achieved solid growth in the first quarter of 2020, in spite of the COVID-19 impact on our Wuhan site, which was closed for almost two months, and dramatically reduced activities in our China clinical research services business. Our revenue grew 15.1% year-over-year to RMB3,188 million and our adjusted Non-IFRS net profit grew 10.8% year-over-year to RMB576 million, which was attributable to the timely implementation of our Business Continuity Plan. We maintained and continue to be in close communication with our global customers through video conferencing."

"For the three months ended March 31, 2020, we added over 240 new customers, including 128 global customers, and our number of active customers continued to exceed 3,900. We also continued to make progress across all business segments. As of March 31, 2020, our small molecule CDMO/CMO pipeline has grown to more than 1,000 active projects, including 42 projects in Phase III clinical trials and 22 in commercial manufacturing, and our cell and gene therapies CDMO business provided services for 35 clinical stage projects, including 24 projects in Phase I and 11 projects in Phase II/III. During the Reporting Period, our success-based drug discovery unit filed INDs for 6 new-chemical-entities for our customers and obtained 5 CTAs. As of March 31, 2020, we have cumulatively submitted 91 new-chemical-entities IND filings for our customers and obtained 62 CTAs."

Dr. Ge Li concluded, "The fundamentals of our business remain very strong. Our laboratories and facilities in China are fully operational and we expect to deliver a strong second quarter. Due to the spread of COVID-19 in the United States, our US operations will be negatively impacted in the second quarter, however, we expect the continued implementation of our Business Continuity Plan to mitigate some of this impact. We are determined to navigate through the COVID-19 crisis in partnership with our global customers, and to assume an even greater responsibility for keeping the R&D and manufacturing engine humming. We are confident that we will win back 2020 and deliver another year of strong growth."

First-Quarter 2020 Adjusted Non-IFRS Results

First-Quarter 2020 adjusted non-IFRS net profit attributable to owners of the Company grew 10.8% year-over-year to RMB576 million. This adjusts for share-based compensation expenses, listing expenses and convertible bonds issuance expenses, fair value gain or loss from conversion option of convertible bonds, foreign exchange-related effects, amortization of intangible assets acquired in business combinations, realized/unrealized gains or losses from our venture investments and realized/unrealized gains or losses from our joint ventures.