On February 27, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported full-year 2018 financial results (Press release, CytomX Therapeutics, FEB 27, 2019, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-full-year-2018-financial-results" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-full-year-2018-financial-results" rel="nofollow">View Source [SID1234533793]). As part of its 2019 Research and Development Day held yesterday in New York, CytomX provided an operational update on the company.

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As of December 31, 2018, CytomX had cash, cash equivalents and short-term investments of $436.1 million, sufficient capital to fund its operating expenses and capital requirement into 2021.

"Over the last year, we have generated meaningful clinical proof of concept data for the Probody platform across both of our lead, wholly-owned programs," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "As we showed at our inaugural Research and Development Day yesterday, our PD-L1 Probody therapeutic, CX-072, is active across a wide range of tumors and has a potentially differentiated safety profile as monotherapy and in combination. CX-2009, our first-in-class CD166 Probody Drug Conjugate, is well tolerated and has demonstrated anti-tumor activity across multiple tumor types. In 2019, we will continue to explore the full potential of these innovative product candidates as we maintain our intense focus on discovery, development and ultimate commercialization of a new generation of differentiated cancer therapeutics."

2018 Business Highlights and Recent Developments

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program

CX-072 is a Probody therapeutic targeting PD-L1, a clinically- and commercially-validated anti-cancer target.
Enrollment began in January 2017 in PROCLAIM-CX-072, a Phase 1/2 clinical trial evaluating CX-072 as monotherapy and in combination with YERVOY (ipilimumab) or Zelboraf (vemurafenib) in patients with cancer.
Enrollment is complete with follow-up continuing in the monotherapy dose escalation arm evaluating CX-072 in patients with advanced unresectable solid tumors or lymphomas (Part A) and in the monotherapy dose escalation arm in patients with PD-L1-positive tumors (Part A2).
Enrollment and follow-up are ongoing in the monotherapy expansion cohorts of CX-072 at 10 mg/kg in multiple indications (Part D).
Data from Parts A, A2 and D was presented most recently at CytomX’s 2019 Research and Development Day.
Additional data from Part D is expected in 2019.
Enrollment of the dose escalation arm combining CX-072 plus Yervoy (ipilimumab) in patients with advanced unresectable solid tumors or lymphomas (Part B) is complete and was presented most recently at CytomX’s 2019 Research and Development Day.
Enrollment is ongoing in the dose escalation combination arm of CX-072 plus Zelboraf (vemurafenib) in patients with V600E BRAF-positive melanoma (Part C).
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a Probody drug conjugate (PDC) that targets CD166, an antigen that is broadly and highly expressed in many types of cancer, and is conjugated with DM4, a clinically-validated toxin licensed from ImmunoGen.
Enrollment began in June 2017 in PROCLAIM-CX-2009, a Phase 1/2 clinical trial, evaluating CX-2009 as monotherapy in a subset of seven cancer types (Part A) and in patients selected for high level of CD166 expression (Part A2).
Preliminary data from Parts A and A2 was presented at CytomX’s 2019 Research and Development Day.
BMS-986249 (CTLA-4 Probody Therapeutic) Clinical Program

Bristol-Myers Squibb (BMS), continues enrollment in a Phase 1/2 clinical trial evaluating BMS-986249 alone and in combination with OPDIVO (nivolumab) in solid tumors that are advanced and have spread.
BMS has stated that they anticipate preliminary data from this trial in 2019.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program

CytomX, in collaboration with AbbVie, is advancing CX-2029, a CD71-directed Probody Drug Conjugate.
CD71, also known as the transferrin receptor 1 (TfR1), is highly expressed in a number of solid and hematologic cancers and has particularly attractive molecular properties for efficient delivery of cytotoxic payloads to tumor cells.
Enrollment began in late June 2018 in PROCLAIM-CX-2029, a Phase 1/2 clinical trial evaluating CX-2029 as monotherapy in patients with solid tumors or lymphomas and is ongoing.
CX-188 (PD-1 Probody Therapeutic) Program

CX-188 is a PD-1-directed Probody therapeutic.
PD-1 is the receptor for the PD-L1 ligand responsible for inhibiting T-cell activation in a variety of cancers and is a clinically- and commercially-validated anti-cancer target.
In October 2018, CytomX filed an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) on CX-188. The CX-188 IND was cleared by the FDA in November 2018. Due to a recent program and portfolio prioritization, the company has decided to indefinitely postpone the CX-188 clinical trials. The company may elect to initiate clinical trials of CX-188 in the future.
CytomX Technology Acquisition from Agensys, Inc.

In January 2019, CytomX announced the acquisition of drug conjugate linker-toxin and CD3-based bispecific technologies from Agensys, Inc., an affiliate of Astellas Pharma Inc.
CytomX Therapeutics 2019 Research and Development Day

CytomX hosted a Research and Development Day on Tuesday, February 26, 2019. A replay of the webcasted event is available under the "Investors & News" section of www.CytomX.com.

Full Year Financial Results

Cash, cash equivalents and short-term investments totaled $436.1 million as of December 31, 2018, compared to $374.1 million as of December 31, 2017.

Revenue was $59.5 million for the year ended December 31, 2018, compared to $71.6 million for the year ended December 31, 2017. The $12.1 million decrease is largely attributable to the recognition of $14.0 million in milestone revenue in 2017 from AbbVie (net of a $1.0 million license fee paid to SGEN) as a result of completion of certain milestones under the CD71 Agreement, the recognition of a $10 million milestone in 2017 from BMS related to the IND filing for BMS-986249, the recognition of $6.5 million in revenue in 2017 related to the delivery of the ImmunoGen 2017 License to ImmunoGen in connection with the ImmunoGen Research Agreement, a decrease of $4.5 million in the amortization of deferred revenue under the ImmunoGen Research Agreement which concluded on June 30, 2018, and a decrease of $0.5 million in revenues from Pfizer as a result of Pfizer terminating our Research Collaboration, Option and License Agreement in March 2018. These decreases were partially offset by the recognition of $11.7 million of revenue in 2018 related to the milestone payment of $21.0 million from AbbVie (net of the associated $4.0 million sublicense fee to SGEN) for the achievement of the IND filing success criteria under the CD71 Agreement, an increase of $7.9 million in amortization of deferred revenue in 2018 related to the $200.0 million upfront payment received in the second quarter of 2017 as a result of the extension of the BMS collaboration, and an increase of $3.6 million of revenue from Amgen under the Amgen Agreement entered into in September 2017.

Research and development expenses increased by $11.6 million during the year ended December 31, 2018 compared to the corresponding period in 2017. The increase was primarily attributed to an increase in lab services of $10.0 million and $12.3 million in clinical trial expenses related to CX-072, CX-2009 and CX-2029 Phase 1/2 clinical development. There was also an increase of $10.5 million in personnel related expenses; $1.2 million increase in allocation of information technology and facilities related expenses; $0.9 million in lab supplies and $0.7 in consulting expenses. These amounts were largely offset by the recognition, during the third quarter of 2017, of $10.7 million of non-cash in-process research and development expense; $12.1 million of sublicense fees payable to the University of California, Santa Barbara, as a result of both the $200 million upfront payment made by BMS in connection with the expanded collaboration and the Amgen Agreement and a $1.0 million sublicense fee to ImmunoGen upon commencement of enrollment of Phase 1/2 and first patient dosing in the clinical trial for CX-2009 in the second quarter of 2017.

General and administrative expenses increased by $7.9 million during the year ended December 31, 2018 compared to the corresponding period in 2017. This increase was largely attributed to an increase of $5.6 million in personnel related expenses due to increases in headcount, and $2.3 million for various consulting and other services.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 3748238. An archive of the webcast will be available on the CytomX website from February 27, 2019, until March 6, 2019.

On February 27, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of an abstract demonstrating a biomarker for predicting clinical response in patients treated with pelareorep (Press release, Oncolytics Biotech, FEB 27, 2019, View Source [SID1234533792]). This analysis was conducted in patient samples from REO 024; a study of pelareorep and Keytruda in combination with chemotherapy in patients with second-line pancreatic cancer. Detailed results will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place March 30 through April 3 in Atlanta, Georgia.

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”With a simple blood draw, this biomarker data allows physicians to understand which patients are likely to respond to treatment, allowing for the design of clinical studies that are cheaper, faster and more likely to succeed,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. ”Our biomarker data that we will present at AACR (Free AACR Whitepaper) is immediately applicable to future clinical studies. Investigators should now be able to predict which patients will respond to pelareorep in combination with a checkpoint inhibitor. This biomarker will be evaluated in our clinical studies with checkpoint inhibitors, including both of our multiple myeloma studies, the AWARE-1 breast cancer study, and importantly, in the same setting this data was produced, our phase two second-line pancreatic study in combination with Keytruda.”

"Using patient blood samples from our REO 024 study in second line pancreatic cancer, T cell receptor sequencing was performed with Adaptive Biotechnologies’ immunoSEQ Assay to measure the diversity or clonality of the T cell population,” said Dr. Rita Laeufle, CMO of Oncolytics Biotech. ”Results from this analysis demonstrate that higher clonality after one three-week cycle of treatment can identify patients likely to respond to combination treatment of pelareorep and a checkpoint inhibitor.”

The results suggest that those patients with a statistically significant change in their T cell population demonstrate a clinical benefit from pelareorep treatment. High T cell clonality correlates with progression free survival at baseline (HR=0.05, p=0.01). Moreover, high clonality correlates with overall survival at both baseline (HR=0.124, p=0.01) and after one cycle of treatment (HR=0.08, p=0.01). This research highlights the potential utility of measuring T cell clonality as a predictive and prognostic biomarker of pelareorep therapy.

The abstract, authored by Dr. Grey Wilkinson, a translational scientist at Oncolytics Biotech, and his colleagues, in collaboration with Northwestern University, UT Health San Antonio and Adaptive Biotechnologies, can be found online at View Source!/6812/presentation/4866. Full details from the poster presentation will be announced after it is presented.

Poster Board Number: 1
Presentation Number: 2272
Title: Exploratory analysis of T cell repertoire dynamics upon systemic treatment with the oncolytic virus pelareorep in combination with pembrolizumab and chemotherapy in patients with advanced pancreatic adenocarcinoma
Date: Monday, April 1
Lecture Time: 1:00 p.m. ET – 5:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 20
Speakers: Grey Wilkinson
Session Category: Clinical Research
Session: Current Developments in Non-invasive Biomarkers for Assessment of Cancer 3

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On February 27, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that data from its Phase II HORIZON study and Phase I/II ANCHOR study evaluating the company’s novel candidate melflufen, a peptide-conjugated alkylator belonging to the novel class of peptidase enhanced compounds, have been selected as poster presentations at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on 29 March – 3 April 2019 in Atlanta, Georgia, USA (Press release, Oncopeptides, FEB 27, 2019, View Source [SID1234533791]).

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– Data demonstrate tolerability and high level of activity associated with melflufen in relapsed/refractory multiple myeloma (RRMM) patients –

– Early signs of high efficacy are encouraging; studies are ongoing –

"Our rigorous clinical development program is initially focused on our first-in-class candidate melflufen, which is currently being studied in global Phase II studies and the Phase III OCEAN study," said Jakob Lindberg, CEO of Oncopeptides. "We are extremely pleased that these data have been selected for poster presentation at AACR (Free AACR Whitepaper), following their initial presentation at the ASH (Free ASH Whitepaper) 2018 Annual Meeting, and believe that this further validates the promise that melflufen holds for the treatment of patients with advanced multiple myeloma whose treatment options are limited."

Melflufen’s novel mechanism of action works by eliciting increased cytotoxicity in target multiple myeloma (MM) cells and substantially reduced off-target cell toxicity. Melflufen is in a pivotal Phase III study, OCEAN, for its initial indication in RRMM under a Special Protocol Assessment from the US Food and Drug Administration (FDA). Based on ongoing preclinical studies, Oncopeptides is also exploring the potential for the use of melflufen, or other peptide-conjugated drugs, to treat various cancers beyond MM.

The full AACR (Free AACR Whitepaper) 2019 Annual Meeting abstract book can be viewed at www.aacr.org.

The posters we present are found under the title:
HORIZON: Melflufen in patients (pts) with relapsed/refractory multiple myeloma (RRMM) refractory to daratumumab (dara) and/or pomalidomide (pom) (OP-106)

ANCHOR: Melflufen and dexamethasone (dex) plus bortezomib (BTZ) or daratumumab (dara) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) (OP-104)

For more information, please contact:
Jakob Lindberg, CEO of Oncopeptides
Telephone: +46 (0)8 615 20 40
E-mail: [email protected]

Rein Piir, Head of Investor Relations at Oncopeptides
Cell phone: +46 70 853 72 92
E-mail: [email protected]

This information was submitted for publication at 22.30 CET, 27 February 2019

On February 27, 2019 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology-focused biopharmaceutical company developing novel therapeutics for global markets, and BioGenetics Co Ltd, a leading South Korean healthcare company, reported that have entered into an agreement whereby both parties will collaborate to commercialise varlitinib in all indications in South Korea (Press release, ASLAN Pharmaceuticals, FEB 27, 2019, View Source [SID1234533789]).

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ASLAN will grant BioGenetics exclusive rights to commercialise varlitinib in South Korea in exchange for an upfront payment of US$2 million and up to US$11 million in sales and development milestones. ASLAN is also eligible to receive tiered double digit royalties on net sales up to the mid-twenties. ASLAN will continue to fund all clinical development of varlitinib, BioGenetics will be responsible for obtaining initial and all subsequent regulatory approvals of varlitinib in South Korea.

ASLAN is currently conducting a global pivotal trial (TreeTopp) in second-line biliary tract cancer (BTC), with topline data expected in the second half of 2019. At the recent ASCO (Free ASCO Whitepaper) GI conference, ASLAN presented positive data from an ongoing multicentre phase 1b/2 clinical trial of varlitinib plus gemcitabine and cisplatin in first-line BTC. Varlitinib has been awarded orphan drug designation for the treatment of BTC by the Ministry of Food and Drug Safety in South Korea, which provides certain benefits for the development and commercialisation of varlitinib in South Korea including an extension of the marketing exclusivity period and exemption of certain local clinical trial requirements.

Dr Carl Firth, Chief Executive Officer of ASLAN Pharmaceuticals, commented: "We are delighted to partner with a team that brings strong knowledge of the South Korean regulatory and commercial environment. We believe BioGenetics is well placed to maximise the value of varlitinib in BTC and potentially other tumour types in the future."

JooHoon Ahn, Chief Executive Officer of Biopharma, BioGenetics, commented: "We are excited by the clinical data in BTC that ASLAN has generated to date. The unmet need for effective treatments for BTC, one of the ten most prevalent cancers in South Korea, is high. Our partnership with ASLAN is in-line with our strategy to identify high-quality, late stage development assets that have the potential to transform treatment paradigms and address pressing needs in oncology. We have attracted a team of experienced pharmaceutical executives to build our pharmaceutical division and we look forward to working closely with ASLAN to realise the potential of varlitinib in South Korea."

In 2015, ASLAN entered a collaboration and license agreement with Hyundai Pharm to develop and commercialise varlitinib for the treatment of cholangiocarcinoma (CCA) in South Korea. Prior to executing a broader agreement with BioGenetics, ASLAN exercised its right to buy back the rights to varlitinib in CCA, making a payment of $0.3M to Hyundai Pharm.

On February 27, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported recent business highlights, anticipated upcoming milestones, and financial results for the fourth quarter and full year of 2018 (Press release, BeiGene, FEB 27, 2019, View Source/phoenix.zhtml?c=254246&" target="_blank" title="View Source/phoenix.zhtml?c=254246&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2389335 [SID1234533788]).

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"Building on a strong foundation, in 2018 we took BeiGene to new heights with our first three new drug applications accepted and currently under priority review in China for zanubrutinib and tislelizumab," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. "In the United States, we received Breakthrough Therapy designation for zanubrutinib in patients with relapsed/refractory mantle cell lymphoma. We have become a global leader in China-inclusive global clinical development, supported by our internal clinical team of more than 800 people and a commitment to high quality standards."

Oyler continued, "In 2019, we plan to continue to grow our commercial business, paving the way for our planned commercial launches in China this year and for our first new drug application in the United States planned for this year or in early 2020."

Recent Business Highlights and Upcoming Milestones

Clinical Programs

Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects

Received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy;
Granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA, formerly known as CFDA) to new drug applications (NDAs) for the treatment of patients with relapsed or refractory (R/R) MCL and with R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL);
Presented full results of the pivotal Phase 2 trial in Chinese patients with R/R MCL in an oral presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting;
Presented updated data from a global Phase 1 trial in patients with MCL at the ASH (Free ASH Whitepaper) Annual Meeting;
Completed enrollment of a significantly expanded cohort 2, of 110 previously untreated patients with 17p deletion in the Phase 3 trial in first-line CLL/SLL; and
Initiated a global Phase 2 trial in patients with R/R marginal zone lymphoma (MZL).
Expected Milestones for Zanubrutinib in 2019

Receive approvals in China for the treatment of patients with R/R MCL and R/R CLL/SLL;
Submit an initial NDA for zanubrutinib in the U.S. in 2019 or early 2020;
Announce top-line results from the pivotal Phase 2 trial in Chinese patients with Waldenström macroglobulinemia (WM) and submit an NDA in China for WM;
Announce top-line results from the Phase 3 trial comparing zanubrutinib to ibrutinib in patients with WM; and
Present updated data from the global Phase 1 trial in WM and MCL; pivotal data from the China Phase 2 trials in R/R MCL and CLL/SLL; Phase 1 obinutuzumab combination data in CLL/SLL; data from the MYD88WT cohort of the Phase 3 WM trial; updated data from the Phase 1 obinutuzumab combination trial in non-Hodgkin’s lymphoma (NHL); and updated data from the global Phase 1 trial in CLL/SLL.
Tislelizumab (BGB-A317), an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages

Granted priority review by the CDE of NMPA to our NDA for the treatment of patients with R/R classical Hodgkin’s lymphoma (cHL);
Presented data from the pivotal Phase 2 trial of tislelizumab in Chinese patients with R/R cHL in an oral session at the ASH (Free ASH Whitepaper) Annual Meeting;
Presented updated data from Phase 1 trial expansion cohorts in patients with urothelial carcinoma, esophageal, gastric, hepatocellular, and non-small cell lung cancers at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) congress;
Presented Phase 2 clinical results in esophageal squamous cell carcinoma (ESCC) and gastric cancer (GC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI);
Completed enrollment of the global Phase 2 trial in second- or third-line patients with hepatocellular carcinoma (HCC); and
Initiated the following clinical trials:
— A global Phase 3 trial of tislelizumab in combination with chemotherapy in patients with front-line advanced gastric or gastroesophageal junction adenocarcinoma; and
— A global Phase 3 trial of tislelizumab in combination with chemotherapy in patients with front-line, locally advanced recurrent or metastatic ESCC.
Expected Milestones for Tislelizumab in 2019

Receive NDA approval in China for treatment of patients with R/R cHL;
Announce top-line results from the pivotal Phase 2 trial in Chinese and Korean patients with PD-L1 positive urothelial bladder cancer (UBC) and submit an NDA in China for UBC;
Announce top-line results from the global Phase 2 trial in second- or third-line patients with HCC and have regulatory discussions;
Present updated China pivotal Phase 2 data in R/R cHL; updated Phase 2 chemotherapy combination data; and Phase 1 data from China trials;
Complete or close to completing enrollment in all four ongoing Phase 3 trials in lung and liver cancers; and
Initiate additional pivotal solid tumor trials.
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor

Presented preliminary Phase 1/2 trial data of pamiparib in combination with radiation therapy and/or temozolomide in patients with newly diagnosed or R/R glioblastoma in an oral presentation at the 23rd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO); and
Initiated a global Phase 2 trial in patients with metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination deficiency (HRD).
Expected Milestones for Pamiparib in 2019

Announce top-line results from the pivotal Phase 2 trial in Chinese patients with previously treated ovarian cancer in late 2019 or early 2020; and
Present data in patients with ovarian cancer from the global Phase 1 trial and updated Phase 1 combination data.
Sitravatinib, an investigational tyrosine kinase inhibitor of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET, licensed from Mirati Therapeutics in Asia (excluding Japan), Australia, and New Zealand

Expanded Phase 1 combination trial with tislelizumab in China and Australia to a total of five advanced solid tumors including non-small cell lung cancer, renal cell carcinoma, ovarian cancer, HCC, and GC.
BGB-A425, an investigational TIM-3 antibody

Initiated a global Phase 1 trial in combination with tislelizumab.
Manufacturing

Substantially completed physical construction of the commercial-scale biologics manufacturing facility in Guangzhou, China, with four 2,000 liter KUBio bioreactors installed.
Expected Milestone for Manufacturing in 2019

Complete Phase 1 construction of the Guangzhou manufacturing facility, with expanded capacity to follow, to support the manufacturing of tislelizumab and other potential drug candidates in the pipeline.
Commercial Operations

Generated $37.76 million and $130.89 million in product revenue in the fourth quarter and year ended December 31, 2018, respectively, from sales in China of ABRAXANE, REVLIMID and VIDAZA, which represents a 142% increase and a 436% increase, respectively, compared to the same periods in 2017 (2017 revenue was from the last four months of the year after the Celgene transaction closed on August 31, 2017); and
In support of the planned commercial launch of zanubrutinib in the United States, the Company made key hires in sales and marketing, market access, commercial operations, and business analytics. In China, the Company more than quadrupled the size of its commercial team since September 2017.
Corporate Developments

Announced license and collaboration agreements with Zymeworks Inc., under which BeiGene acquired exclusive development and commercial rights in Asia-Pacific for Zymeworks’ HER2-targeted therapeutic candidates ZW25 and ZW49, and a research and license agreement under which BeiGene acquired rights to internally develop and commercialize globally up to three other bispecific antibodies using Zymeworks’ Azymetric and EFECT platforms; and
Appointed Dr. Yong (Ben) Ben as Chief Medical Officer, Immuno-Oncology. Dr. Ben has extensive experience in immuno-oncology and early- to late-stage drug development, with multiple successful NDAs and biologics license applications (BLAs), including most recently the approval of PD-L1 immunotherapy IMFINZI (durvalumab) for the treatment of certain patients with locally advanced or metastatic urothelial cancer. Prior to joining BeiGene, he served most recently as chief medical officer of BioAtla, and previously worked at other pharmaceutical companies, including AstraZeneca, Millennium Pharmaceuticals, and Pfizer.
Fourth Quarter and Full Year 2018 Financial Results

Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1.81 billion as of December 31, 2018, compared to $2.10 billion as of September 30, 2018 and $837.52 million as of December 31, 2017.

The decrease of $291.85 million in the fourth quarter of 2018 was primarily due to $193.89 million of cash used in operating activities, a $60 million upfront payment made to Zymeworks under our collaboration agreement, $23.25 million for investments in property, plant and equipment, and the payment of the remaining $30.35 million acquisition cost for our research, development, and office facility in Changping, Beijing, China.
The increase of $971.71 million from the prior year period was primarily due to net proceeds received from our global follow-on offering and initial listing on the Hong Kong Stock Exchange of $869.71 million in August 2018 and net proceeds from our follow-on offering on the NASDAQ of $757.59 million in January 2018. These net proceeds were partially offset by $547.72 million of cash used in operating activities, $70 million in upfront payments related to the Zymeworks and Mirati collaboration agreements, investments in property, plant and equipment totaling $70.28 million and primarily attributable to the build-out of our Guangzhou biologics manufacturing facility, and $38.30 million of total cost related to the acquisition of our Changping facility.
Revenue for the fourth quarter and year ended December 31, 2018 was $58.67 million and $198.22 million, respectively, compared to $18.17 million and $238.39 million in the same periods in 2017. The increase in the quarter-over-quarter period is attributable to increased product revenue in China and collaboration revenue under our license and collaboration agreements with Celgene. The decrease in the year-over-year period is due to the upfront payment recognized in 2017 under our collaboration agreement with Celgene for tislelizumab.

Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA in China totaled $37.76 million and $130.89 million for the fourth quarter and year ended December 31, 2018, respectively, compared to $15.61 million and $24.43 million for the same periods in 2017 (2017 revenue was from the last four months of the year after the Celgene transaction closed on August 31, 2017).
Collaboration revenue totaled $20.91 million and $67.34 million for the fourth quarter and year ended December 31, 2018, respectively, compared to $2.57 million and $213.96 million for the same periods in 2017.
Expenses for the fourth quarter and year ended December 31, 2018 were $339.48 million and $903.99 million, respectively, compared to $121.97 million and $336.84 million in the same periods in 2017.

Cost of sales for the fourth quarter and year ended December 31, 2018 were $9.19 million and $28.71 million, respectively, compared to $3.03 million and $4.97 million in the same periods in 2017 (the full year period in 2017 included only the last four months of the year after the Celgene deal closed on August 31, 2017). Cost of sales related to the cost of acquiring ABRAXANE, REVLIMID and VIDAZA for distribution in China.
R&D Expenses for the fourth quarter and year ended December 31, 2018 were $257.46 million and $679.01 million, respectively, compared to $91.34 million and $269.02 million in the same periods in 2017. The increase in R&D expenses was primarily attributable to increased spending on our ongoing and newly initiated late-stage pivotal clinical trials, preparation for regulatory submissions and commercial launch of our late-stage drug candidates, manufacturing costs related to pre-commercial activities and supply, as well as increases in spending related to our preclinical-stage programs. Also contributing to the fourth quarter and year-over-year increases were expenses for in-process research and development collaborations, which totaled $79 million in the fourth quarter of 2018 (including $60 million related to the Zymeworks collaboration and $19 million related to the termination of the Merck pamiparib collaboration) and $89 million (inclusive of the $10 million related to the Mirati collaboration) for the year ended December 31, 2018. We did not have any in-process research and development expense from collaborations in the fourth quarter or year ended December 31, 2017. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was $16.09 million and $54.38 million for the fourth quarter and year ended December 31, 2018, respectively, compared to $10.95 million and $30.61 million for the same periods in 2017, due to increased headcount and a higher share price.
SG&A Expenses for the fourth quarter and year ended December 31, 2018 were $72.49 million and $195.39 million, respectively, compared to $27.42 million and $62.60 million in the same periods in 2017. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our commercial products in China and the potential launches of our late-stage drug candidates, as well as higher professional service fees and costs to support our growing operations. The overall increase in SG&A expenses was also attributable to higher SG&A-related share-based compensation expense, which was $9.87 million and $32.74 million for the fourth quarter and year ended December 31, 2018, respectively, compared to $5.51 million and $12.25 million for the same periods in 2017, due to increased headcount and a higher share price.
Net Loss for the fourth quarter and year ended December 31, 2018 was $268.26 million and $673.77 million, or $0.35 and $0.93 per share, or $4.52 and $12.15 per American Depositary Share (ADS), respectively, compared to $99.32 million and $93.11 million, or $0.17 and $0.17 per share, or $2.19 and $2.23 per ADS, respectively, in the same periods in 2017.
Conference Call and Investor Event

The Company will hold a live webcast and conference call of fourth quarter and full year 2018 financial results, and business updates and expected upcoming milestones, at 6:00 p.m. EST on February 27 (7:00 a.m. HKT on February 28.) The conference call will be conducted in English, and can be accessed by dialing +1 (844) 461-9930 or +1 (478) 219-0535 in the U.S.; +852 3011-4522 in Hong Kong; or +86 400-682-8609 in mainland China. Please dial in five minutes prior to the start time and provide the passcode 8889396.

In addition, the Company will host an investor and analyst event in Hong Kong from 2:30 p.m. to 4:00 p.m. HKT on February 28 (Thursday, February 28, at 1:30 a.m. EST). This event will be conducted primarily in Mandarin Chinese.

Both events will have live webcast and can be accessed by visiting the investor relations section of the BeiGene website at View Source and/or View Source The replay of both events will be available on the BeiGene website approximately two hours following completion of the events and will be archived for three weeks.

[1] The bank loan is attributable to BeiGene Biologics, a joint venture that is 95% owned by BeiGene, Ltd, totaled $40.79 million as of December 31, 2018 and the current portion of long-term debt for a term note secured by our Suzhou manufacturing facility
[2] The shareholder loan is attributable to a RMB900 million convertible note obtained in 2017 from our joint venture partner for the construction and operation of our manufacturing facilities in Guangzhou.

Condensed Consolidated Statements of Operations (U.S. GAAP)
(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data)

[1] Research and development expense for the fourth quarter and year ended December 31, 2018 includes expenses related to in-process research and development collaborations totaling $79 million and $89 million, respectively.