On March 30, 2021 Immunovia reported improved performance of its blood based IMMray PanCan-d biomarker signature together with CA 19-9, in a clinical retrospective study (Press release, Immunovia, MAR 30, 2021, View Source [SID1234577294]). The study was designed to evaluate detection of early stage pancreatic cancer in high risk patients with non-specific but concerning symptoms. The study data demonstrate that Immunovia’s test now detects pancreatic cancers (all stages) with 92% specificity and 81% sensitivity for this cohort, which is equivalent to results presented in the previous Commercial Test Model Study (link to PR). Importantly, early stage PDAC I/II were detected with specificity of 92% and sensitivity of 80%. The improved test performance was demonstrated in a combined samples cohort of newly collected samples and samples from the Clinical Verification study. In total 433 samples of which 202 were PDACs whereof 89 PDAC stage I/II and 231 symptomatic controls were analyzed. These samples have been freshly collected from 7 sites in the US and Europe: Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, Pancreatic Cancer Center at NYU Langone’s Perlmutter Cancer Center in the US; University College London in the UK; Sahlgrenska University Hospital in Sweden; and University Hospital Erlangen in Germany; and Ramón y Cajal University Hospital, IRYCIS, CIBERONC in Spain.

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Linda Mellby, PhD, VP R&D Immunovia commented: "Detecting pancreatic cancer as early as possible in high risk symptomatic patients is a challenging but extremely important achievement that will support clinicians in providing accelerated and correct diagnosis to the patients. We are very excited to report 92% specificity and 80 % sensitivity for detecting early stage pancreatic cancer in this risk group of patients."

Patrik Dahlen, CEO, Immunovia added: " These results demonstrate great performance for detection of early stage pancreatic cancer in symptomatic cohorts, and they further confirm the commercialization strategy for this important risk group of patients. The market size for the symptomatic risk group is 1-2 million patients in USA and Europe. Our test is designed to help clinicians find the cancer at a treatable stage and thus help the patients live longer."

Webcasted teleconference

These results will be presented Tuesday March 30, 2021, in a webcasted teleconference at 16.30 (CET).

Presenters: Thomas King, MD, PhD, Linda Mellby, PhD, Patrik Dahlen CEO, Immunovia

The presentations will be followed by a Q&A session. The webcasted teleconference will be held in English.

On March 30, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the fiscal year ended December 31, 2020 and provided a business update on recent corporate and clinical developments (Press release, Protalix, MAR 30, 2021, View Source [SID1234577333]).

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"2020 was an important year for Protalix, as we continued to strengthen the clinical profile of PRX–102 for the treatment of Fabry disease and advance towards potential commercialization of our lead pipeline program," said Dror Bashan, Protalix’s President and Chief Executive Officer. "We advanced our earlier stage pipeline with the exclusive partnership we announced with SarcoMed USA for our PRX–110 asset, and we solidified our balance sheet to provide the financial backing to drive the Company through our 2021 milestones."

"We expect 2021 will also be an important year for Protalix as we await the FDA’s review of the PRX–102 BLA on the upcoming April 27, 2021 PDUFA date. We are grateful to our employees and external partners for their commitment and dedication during a very challenging time with the global pandemic. We look forward to continuing to build stockholder value," concluded Mr. Bashan.

2020 Full-Year and Recent Business Highlights

Regulatory Advancements

On August 11, 2020, the Company, together with its development and commercialization partner, Chiesi Farmaceutici S.p.A., or Chiesi, announced that the FDA had accepted the BLA for PRX–102, and granted Priority Review designation for PRX–102, for the proposed treatment of adult patients with Fabry disease. The FDA indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application. The FDA set a PDUFA action date of January 27, 2021. However, as previously announced in November 2020, the FDA subsequently extended the PDUFA action date to April 27, 2021. As we disclosed last year, the FDA has advised that it will have to inspect our manufacturing facility and the facility of a third party in Europe that performs fill and finish processes for PRX-102 as part of its review of the BLA to ensure cGMP compliance. Due to COVID-19-related FDA travel restrictions, the FDA has advised that it may be unable to conduct the inspections prior to the PDUFA action date. The Company, together with Chiesi, is addressing this issue.
Clinical Advancements

On February 23, 2021, the Company, together Chiesi, announced positive topline results from the phase III BRIGHT clinical trial, a study designed to evaluate the safety, efficacy and pharmacokinetics of pegunigalsidase alfa, or PRX–102, treatment, 2 mg/kg every four weeks, in up to 30 patients with Fabry disease previously treated with a commercially available enzyme replacement therapy (ERT) (agalsidase alfa – Replagal or agalsidase beta – Fabrazyme). Topline results indicate that 2 mg/kg of PRX-102 administered by intravenous infusion every four weeks was found to be well tolerated among treated patients, and stable clinical presentation was maintained in adult Fabry patients.
On December 30, 2020, the Company, together with Chiesi, announced final study results from the phase III BRIDGE clinical trial, a 12–month open-label, single arm switch-over study evaluating the safety and efficacy of PRX–102, 1 mg/kg infused every two weeks, in up to 22 Fabry patients. Final results of the data generated in the study showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched from agalsidase alfa to PRX-102.
On October 2, 2020, the Company, together with Chiesi, announced the launch of an Expanded Access Program (EAP) in the United States for PRX–102 for the proposed treatment of Fabry disease.
Corporate & Financial Developments

On February 17, 2021, the Company successfully completed a public offering of its common stock raising gross proceeds of approximately $40.2 million at a price equal to $4.60 per share, before deducting the underwriting discount and estimated expenses of the offering, which was led by BofA Securities and Oppenheimer & Co.
On February 10, 2021, the Company entered into an exclusive partnership with SarcoMed USA for the worldwide development and commercialization of alidornase alfa, or PRX-110, for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis and other related diseases via inhaled delivery.
On March 18, 2020, the Company successfully completed a private placement of its common stock to certain existing and new institutional and other accredited investors raising aggregate net proceeds of approximately $41.3 million at a price equal to $2.485 per share. Each share of common stock issued in the transaction was accompanied by a warrant to purchase an additional share of common stock at an exercise price equal to $2.36.
On March 16, 2020, the Company announced that it had agreed to conduct a feasibility study with Kirin Holdings Company, Limited, or Kirin, to evaluate the production of a novel complex protein utilizing ProCellEx. Kirin is providing research funding for Protalix scientists to conduct cell line engineering and protein expression studies on the target protein.
Financial Results

For the year ended December 31, 2020, compared to the year ended December 31, 2019

The Company recorded revenues from selling goods of $16.2 million for the year ended December 31, 2020 compared to revenues of $15.9 million for the same period of 2019.
Revenue from licenses and R&D services for the year ended December 31, 2020 were $46.7 million compared to $38.8 million for the year ended December 31, 2019. Revenue from license agreements is recognized in conjunction with the license and supply agreements with Chiesi. The increase is primarily due to revenues recognized in connection with an updated cost estimation of two completed phase III clinical trials of PRX-102.
Cost of goods sold was $10.9 million for the years ended December 31, 2020, and December 31, 2019.
Research and development expenses net for the year ended December 31, 2020 were $38.2 million compared to $44.6 million for the year ended December 31, 2019. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX-102 and reduced costs related to the phase III BALANCE study, as well as a decrease in costs related to manufacturing of the Company’s drug in development as some of the manufactured drug product and related costs have been recorded as inventory. The Company expects research and development expenses to continue to be its primary expense as it enters into a more advanced stage of preclinical and clinical trials for certain of its product candidates.
Selling, general and administrative expenses were $11.1 million for the year ended December 31, 2020, an increase of $1.2 million, or 12%, from $9.9 million for the year ended December 31, 2019. The increase resulted primarily from an increase in share-based compensation costs.
Financial expenses, net was $9.2 million for the year ended December 31, 2020 compared to $7.6 million for the same period of 2019.
Cash, cash equivalents and short-term bank deposits were approximately $38.5 million on December 31, 2020. During the first quarter of 2021, the Company raised gross proceeds of $8.8 million from the sale of common stock under its ATM program and gross proceeds of $40.2 million via the public offering of its common stock.
Net loss for the year ended December 31, 2020 was $6.5 million, or $0.22 per share, basic and diluted, compared to a net loss of $18.3 million, or $1.23 per share, basic and diluted, for the same period in 2019.
Conference Call and Webcast Information

The Company will host a conference call today, March 30, 2021 at 8:30 am Eastern Daylight Time, to review the clinical, corporate, and financial highlights, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Conference Call Details:

The conference call will be webcast live from the Company’s website and will be available via the following links:

Webcast Details:

Company Link: View Source
Webcast Link: View Source
Conference ID: 13716316

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On March 30, 2021 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints reported the closing of a $73 million Series B1 and B2 financing (Press release, Immune-Onc Therapeutics, MAR 30, 2021, View Source [SID1234577375]). The round was led by Oceanpine Capital with participation from additional new investors including Octagon Capital and Sphera Healthcare, and existing investors, including Northern Light Venture Capital and Vivo Capital. In conjunction with this round of financing, Oceanpine CEO and managing partner Dave Chenn joins the Immune-Onc Board of Directors. In addition, the company received a strategic capital investment from The Leukemia & Lymphoma Society’s Therapy Acceleration Program (LLS TAP), directed toward advancing the company’s work to treat blood cancers.

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"We are delighted that this high-caliber group of new and existing investors share our excitement about the transformative potential of myeloid checkpoint inhibition and believe in Immune-Onc’s ability to deliver on this promise with our pipeline of first-in-class cancer immunotherapies," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "This round of investment was substantially over-subscribed, enabling the company to accelerate the clinical development of multiple novel assets, and deliver what we believe is the next breakthrough in immunotherapy treatment for many of the world’s most devastating cancers."

Proceeds from the financing will allow Immune-Onc to advance its portfolio of blood cancer and solid tumor immunotherapies targeting myeloid checkpoints with a focus on the LILRB family. Immune-Onc has raised more than $110 million from investors since the company began operations in 2016. In August 2020, the company announced it had been awarded a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to support clinical development of IO-202.

"We are enthusiastic about Immune-Onc’s novel approach to cancer immunotherapy targeting myeloid checkpoints and their leading portfolio of first-in-class assets," said Dave Chenn, CEO and managing partner of Oceanpine Capital. "We have full confidence in the company’s highly experienced management team and are excited to be at the forefront of this new area of research and development through our investment in Immune-Onc supporting their next phase of growth."

Immune-Onc’s Pipeline

Immune-Onc’s research and development programs focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints to overcome immune resistance of cancer. The company has invested in proprietary models, assays and tools to interrogate the biology and translate this cutting-edge research into the development of novel therapies.

Immune-Onc’s lead program IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), is being developed to treat blood cancers, including acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML), and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of hematologic cancer cells.

In September 2020, Immune-Onc initiated a Phase I trial evaluating IO-202 in AML with monocytic differentiation and in CMML. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation status for treatment of AML in October 2020. The company is also evaluating IO-202 in solid tumors and will present preclinical data for the first time on April 10, 2021 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (#AACR21).

Immune-Onc has active preclinical programs targeting other members of the LILRB family including IO-108, a novel antagonist antibody targeting LILRB2 (also known as ILT4) which is currently in the IND-enabling stage. The company presented preclinical data supporting IO-108 for the treatment of solid tumors at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting and plans to submit an investigational new drug application in mid-2021. Other preclinical assets include IO-106, a first-in-class anti-LAIR1 antibody, and multiple undisclosed programs for solid tumors and hematologic malignancies.

About The Leukemia & Lymphoma Society and Therapy Acceleration Program (TAP)

The Leukemia & Lymphoma Society (LLS) is a global leader in the fight against cancer. The LLS mission is to cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. LLS TAP is a strategic initiative that builds business alliances and collaborations with biotechnology companies and academic researchers to identify potential breakthrough therapies with the ability to change the standard of care. LLS TAP funds late-stage pre-clinical studies, and proof of concept or registrational clinical trials to help advance therapeutics along the drug development and approval pathway. To learn more, visit www.LLS.org/therapy-acceleration-program. Follow LLS on Facebook, Twitter, and Instagram.

On March 30, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported its financial results for the year ended December 31, 2020 and the corporate progress. In 2020, the Company achieved total revenue of RMB 3843.8 million (Press release, Innovent Biologics, MAR 30, 2021, View Source [SID1234577391]). In addition to the first commercial product TYVYT (sintilimab injection), the Company successfully added three more antibody drugs to the commercial portfolio with the NMPA approval of BYVASDA (bevacizumab biosimilar), SULINNO (adalimumab biosimilar) and HALPRAZA (rituximab biosimilar), becoming the only biopharmaceutical company that successfully launched four antibody drugs in China in only nine years since inception.

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated, "2020 is a landmark year for Innovent. In the past year, despite the challenges of COVID-19, we minimized the impact on our business and achieved remarkable milestones. We ensured product supply with the non-stop operation of our production line even during the peak of pandemic in the beginning of 2020. Production capability expanded significantly from 5,000L to 24,000L. With the NRDL coverage, we more than doubled the sales of Tyvyt with even higher volume growth. We kept advancing our valuable assets rapidly in China and globally, with six NDAs submitted, four NDAs approved, five assets in Phase 3 or pivotal Phase 2 stage, and 14 assets in the early clinical stage. We also accelerated our global footprint with six assets under global development and a series of international collaborations achieved. More importantly, we’ve upgraded our R&D platform to strive toward global innovation for the next stage."

"With the conclusion of the ninth year since incepted, we are now starting the final year of our first decade. Up to now we have built Innovent from a biotech start up to a biopharmaceutical company with a fully integrated functional platform. However, this is just a start. Our journey to excellence is still in the infancy stage. Heading into the next decade, we are committed to moving Innovent to become a global innovative biopharmaceutical company, capturing the substantial potential of the rising innovative drug market both in China and globally, as well as and delivering tremendous value for our patients, employees, and shareholders."

Business Highlights during 2020 to Year-to-Date 2021

Four commercial product portfolio with three new drugs approved; RMB 2,367.5 million product revenue in 2020

After the first product TYVYT (sintilimab injection) was approved in 2018, BYVASDA (bevacizumab biosimilar), SULINNO (adalimumab biosimilar) and HALPRAZA (rituximab biosimilar) were approved by the NMPA during 2020, making Innovent the only biopharmaceutical company that successfully launched four antibody drugs in China in only nine years since inception.
Total product revenue reached RMB 2,367.5 million for the year ended 31 December 2020, an increase of 133.0% compared to RMB 1,015.9 million in the prior year.
The leading product TYVYT (sintilimab injection) generated RMB2,289.8 million in revenue for the year ended 31 December 2020. This represents an increase of 125.4% from RMB1015.9 million in the prior year.
In addition, TYVYT (sintilimab injection) was approved as the first line treatment for non-squamous non-small cell lung cancer (NSCLC) in February 2021. Three more supplemental new drug applications (sNDA) for TYVYT (sintilimab injection) were under NMPA review with expected approval by 2021 or early 2022, including: 1) the first line treatment for squamous NSCLC; 2) the first line treatment for hepatocellular carcinomas in combination with BYVASDA (bevacizumab biosimilar), and 3) the second line treatment of squamous NSCLC.
Robust pipeline of 23 diverse-staged assets

The company has built up a highly differentiated and competitive pipeline consisting of 23 clinical stage valuable assets that are being developed globally, including four assets approved, five assets under Phase 3 or pivotal studies and 14 assets in other clinical stage. The 23 assets cover major areas including monoclonal antibodies, bispecific antibodies, CAR-T and small molecules etc.
Five assets in Phase 3 or pivotal clinical trial

In addition to the four commercial products, the Company owns a total of five assets in Phase 3 or pivotal clinical studies that are expected to be launched within the next several years, including:

IBI-310 (CTLA-4 monoclonal antibody)
IBI-375 (FGFR inhibitor)
IBI-376 (PI3Kδ inhibitor)
IBI-306 (PCSK9 monoclonal antibody)
IBI-326 (BCMA CAR-T)
Comprehensive and differentiated pipeline in oncology and immunology

Supported by the Company’s deep understanding in immunology (IO) and the unique strength in monoclonal antibody and bispecific antibody, the Company’s IO assets have high degree of differentiation and lead the development progress even in the global market. The comprehensive pipeline cover most of the promising IO targets including PD-1, CD47, LAG-3, TIGIT etc.

In CD47 area: the Company owns three differentiated assets in the area. The potential best-in-class CD47 monoclonal antibody IBI-188 have completed Phase 1a dose escalation and started Phase 1b in 2020. The Company plans to enter phase III or pivotal clinical trial this year for 1L MDS for IBI-188. IBI-322 is a first-in-class PD-L1/CD47 bispecific antibody under Phase 1 study in China and the US. The Company plans to obtain proof-of-concept (PoC) data for IBI-322 in 2021. The Company also has the potential best-in-class SIRPα monoclonal antibody under pre-clinical research stage.
In LAG-3 area: the Company’s LAG-3 monoclonal antibody IBI-110 is the first LAG-3 approved for IND in China. The Company has completed phase 1b enrollment for IBI-110 and will obtain PoC data in 2021. The potential first-in-class PD- L1/LAG-3 bispecific antibody has also received IND approval recently, and the Company will start Phase 1 study in 2021.
In TIGIT area: the TIGIT monoclonal antibody IBI-939 has entered Phase 1b study, with plan to obtain PoC data in 2021. The Company also submitted the IND application for its PD-1/TIGIT bispecific antibody IBI-321 recently, and plans to start clinical study in 2021.
Besides, in 2020, the PD-1/PD-L1 bispecific antibody IBI-318 has finished Phase 1a study and entered multiple Phase 1b studies to explore the potential of IBI-318 in different cancer indications.
Featured non-oncology pipeline with significant progress

The Company’s featured pipeline in non-oncology cover high potential areas with unmet medical needs, including autoimmunity, metabolism, cardiovascular and ophthalmology. In particular, two unique assets with Best-in-Class or First-in-Class potentials made significant progress in 2020, including:

IBI-302 (VEGF/complement fusion protein): The Company has completed the Phase 1a study with optimistic preliminary data for the treatment of wet age-related macular degeneration ("wet AMD"). The Company plans to start Phase 2 clinical study in 2021.
IBI-362 (OXM3): The Company is conducting Phase 1b studies in both obesity objects and diabetic patients. IBI-362 has shown very promising effect on glucose control and weight reduction. The Company plans to start Phase 2 clinical studies in 2021.
Entered strategic collaborations with world-class partners

The company has made a series of collaborations with international and regional partners during the year of 2020. In particular:

The strategic expanded licensing out agreement with Lilly on the exclusive rights of TYVYT (sintilimab injection) outside of China marked the first major step in bringing our innovative portfolio to the global market.
The collaboration with Roche on the discovery and development of bispecific antibodies and multiple cell therapies shows the recognition of our drug discovery and R&D capabilities by a global top-tier pharmaceutical company, and could also further enrich our potential First-in-Class pipeline down the road.
Significant expansion in manufacturing capacity

In 2020, the Company expanded the manufacturing capacity from 5,000L to a total of 24,000L production capacity to support the production needs for both commercial product and clinical stage candidates in the pipeline.
In 2020, the Company has also started the construction of a new manufacturing facility that is designed to house additional twelve 3,000L production capacities, which once completed, will expand the production capacity to a total of 60,000L.
Continuous enlargement of talent pool; upgrade of R&D toward global innovation

In the year of 2020, the talent team increase from about 2,000 employees as at 31 December 2019 to more than 3,200 employees as at 31 December 2020.
In particular, the Company appointed Dr. Yongjun Liu, a renowned world class scientist and successful leader in biopharmaceutical industry as the president of the Company, responsible for our global R&D, portfolio strategy, business development as well as international operation.
In order to achieve the strategic goal of global innovation, the Company is upgrading the R&D to a fully functional structure with global scope, global talents and global vision.
Fruitful capital market achievements

In 2020, the "B" marker was also successfully removed from the Company’s stock name.
The stock was also included in the Hang Seng Composite Index and the Stock Connect in 2020.
During 2020 to year to the date of 2021, the Company has successfully raised a total of approximately US$1.3 billion fund from three rounds of new share placements, backed by strong subscription of well-known international and regional investors.
As the end of February 2021, the Company has approximately US$1.8 billion cash on hand, providing a strong support to our drug R&D, potential business collaboration, production facility expansion and increased international operation needs.
Financial highlights for the year ended December 31, 2020

Total revenue was RMB3,843.8 million for the year ended 31 December 2020, representing an increase of 266.9% from RMB1047.5 million in the prior year. The growth was mainly driven by the strong product growth as well as increase in license fee and service income in 2020.
Product revenue increased by 133.0% to RMB2,367.5 million in 2020 from RMB1,015.9 million in 2019. This was mainly driven by the strong growth of our leading product Tyvyt coupled with revenue contribution of three newly approved antibody drugs in the second half of 2020.
R&D expenses increased by 43.0% to RMB1,851.5 million for 2020. The R&D expenses were spent on progressing clinical trials of late-stage and prioritized assets towards our robust pipeline globally, and expanding collaboration and licensing programs to further enhance our all-rounded R&D capabilities.
Loss and total comprehensive expenses decreased by 42.0% to RMB998.4 million. This reduction in loss was primarily driven by higher product sales as well as license fee income from the upfront payment for the out-license of Tyvyt to Lilly in ex China region.

On March 30, 2021 LONDON, Silence Therapeutics plc, AIM: SLN and Nasdaq: SLN ("Silence" or "the Company"), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, reported its audited full year results for the year ended 31 December 2020 (Press release, Silence Therapeutics, MAR 30, 2021, View Source [SID1234577429]).

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Mark Rothera, President and CEO of Silence Therapeutics, commented: "2020 was a transformational year for Silence Therapeutics, driven by the remarkable resilience of our people in what was a challenging year for the world. We have made significant progress with our mRNAi GOLD platform, with both lead programmes now in the clinic and three data readouts due this year. Alongside advancing our wholly owned pipeline, we continue to progress our high-value partnerships and through this two-pronged approach, our goal is to deliver 2-3 INDs per year from 2023. We are well positioned for success and motivated by our vision to transform people’s lives through our precision engineered medicines."

Craig Tooman, CFO of Silence Therapeutics, commented: "Silence ended 2020 in a strong financial position, driven by non-dilutive funding from our collaborations. Our balance sheet has been further strengthened by the recent $45 million financing, which demonstrated the growing appreciation for Silence and expanded our global shareholder base. We will look to build upon this in 2021 as we continue to enhance our capabilities and maximise the opportunity of our mRNAi GOLD platform."

Operational Highlights

Advanced both wholly owned product candidates, SLN360 for cardiovascular disease due to high Lipoprotein(a), or Lp(a) levels and SLN124 for thalassaemia and myelodysplastic syndrome (MDS).

SLN360 received approval of an initial drug application (IND) by the FDA and Silence initiated the APOLLO Phase 1 study in people with high Lp(a) levels.

SLN124 was granted rare paediatric disease designation for thalassaemia as well as orphan drug designations for MDS and thalassaemia by the FDA.

Initiated the GEMINI Phase 1 study of SLN124 in healthy volunteers.

Secured a significant collaboration deal with AstraZeneca to discover and develop siRNA therapeutics for up to 10 targets in cardiovascular, renal, metabolic and respiratory diseases.

Upfront cash payment of $20m was received and another $40m is due in the first half of 2021.

Deal economics include up to $400m in milestone payments and royalties for each programme.

Expanded RNAi collaboration with Mallinckrodt for complement-mediated diseases with Mallinckrodt exercising options to license two additional targets from Silence, bringing the total to the maximum three programmes envisaged in the collaboration deal.

Commenced a technology evaluation with Takeda to explore the potential of using Silence’s mRNAi GOLD platform against a novel, undisclosed target.

Appointed Dr Giles Campion as Executive Director, Dr Marie Wikström Lindholm as Senior Vice President, Molecular Design, Dr Eric Floyd as Senior Vice President, Head of Global Regulatory Affairs and Quality Assurance and Dr Barbara Ruskin as Senior Vice President, General Counsel and Chief Patent Officer.

Launched a Scientific Advisory Board comprising world-leading scientists and clinicians to support the optimisation of Silence’s mRNAi GOLD platform and guide development strategies for SLN360 and SLN124.

Completed U.S. listing and our American Depository Shares (ADSs) began trading on the Nasdaq Capital Market (Nasdaq) under the symbol "SLN" on 8 September 2020.

Appointed Mark Rothera as our President, Chief Executive Officer and Board member.

Financial Highlights

Cash and cash equivalents and term deposits of £37.4m at year-end (2019: £33.5m). The Group had £97.5m on a proforma basis, which includes £37.4m at year-end, plus the £29.3m ($40m) receivable from AstraZeneca due in the first half of 2021, plus net proceeds of £30.8m from the February 2021 capital raise.

Cash flow from operating activities was £10.8m outflow (2019: £1.7m inflow) against an operating loss of £35.8m (2019: £22.7m). 2020 included receipts of $20m upfront from AstraZeneca, $2.0m in milestones from Mallinckrodt Pharmaceuticals, and a $2.0m upfront from Takeda.

2020 loss was higher primarily due to increased research and development spend in relation to our SLN360 and SLN124 proprietary programmes, as well as general and administrative expenses mainly relating to the Nasdaq listing.

Post Year-end

Appointed Dr Michael H. Davidson to the Silence Board of Directors as a Non-Executive Director and Craig Tooman to the Executive Leadership Team as Chief Financial Officer.

Completed an oversubscribed $45m (c. £33m) private placement led by top-tier US institutional healthcare funds.

Initiated dosing in the APOLLO Phase 1 study of SLN360 in people with high Lp(a) levels.

Initiated work with Mallinckrodt on the third complement target which triggered a $2.0m research milestone payment to Silence.

Completed enrolment in the GEMINI Phase 1 study of SLN124 in healthy volunteers.

Initiated the GEMINI II Phase 1b study of SLN124 in people with thalassemia and MDS.