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ERYTECH TO PARTICIPATE IN UPCOMING VIRTUAL INVESTOR CONFERENCES IN MARCH

On February 24, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that Chief Executive Officer, Gil Beyen, will present at the following conferences in the month of March and participate in select one-on-one investor meetings alongside members of the senior management (Press release, ERYtech Pharma, FEB 24, 2021, View Source [SID1234575739]).

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Cowen and Company – 41st Annual Health Care Conference – March 1-4, 2021

Gil Beyen, Chief Executive Officer, will participate in the GI Oncology and Pancreatic Cancer Panel Discussion on March 2, 2021 at 9:50am ET and management will conduct one-on-one meetings with investors during the conference.

The GI Oncology and Pancrearic Cancer Panel will stream live and a replay will be available on Cowen’s Conference Site: View Source

H.C. Wainwright – Global Life Sciences Conference, March 9-10, 2021

A pre-recorded corporate presentation will be accessible to conference attendees starting on Tuesday, March 9th 2021 at 7am ET to 90 days after the event. Management will conduct one-on-one meetings with investors during the conference.

A link to the HCW webcast will be accessible via ERYTECH’s website at View Source

If you are interested in arranging a one-on-one meeting request please contact your bank conference representative or contact Corey Davis at LifeSciAdvisors.

YishengBio Raises $130 Million in Series B Funding to Accelerate Pipeline Development and Commercialization

On February 24, 2021 YishengBio Co., Ltd. ("YishengBio", the "Company") reported the closing of a US$130 million in Series B funding round (Press release, Yisheng Biopharma, FEB 24, 2021, View Source [SID1234575622]). The new investment was co-led by Oceanpine and OrbiMed. After completing the Series B funding round, the company’s institutional investors include: OrbiMed, Oceanpine, EightRoad, F-Prime Capital, 3W Capital, Hillhouse Capital, Adjuvant Capital, MSA Capital, AIHC, Epiphron Capital, Superstring Capital, Haitong International, etc. This round of funding will strongly support the expansion of the company’s R&D center, accelerate our commercialization strategies including the clinical development of multiple vaccine candidates and the construction of biologics production facilities in China and Singapore. CEC Capital was the company’s exclusive financial advisor in Series B funding round. Wilson Sonsini Goodrich & Rosati and Tian Yuan Law Firm acted as the international legal counsel and legal counsel in China of YishengBio respectively. Sidley Austin LLP acted as the legal counsel of OrbiMed and Adjuvant Capital. Han Kun Law Offices acted as the legal counsel of Oceanpine Capital.

YishengBio is a global, fully integrated biopharmaceutical company headquartered in Beijing. The company is engaged in discovering, developing and commercializing innovative biotherapeutics for cancers and infectious diseases using novel PIKA immunomodulating technology. YishengBio operates in China, USA, and Singapore with over 500 employees. YishengBio’s YSJA rabies vaccine is the first alum-free lyophilized rabies vaccine launched in China. The rabies vaccine has been commercialized in China and has served over 16 million patients for post-exposure protection against rabies. The novel PIKA immunomodulating technology platform is a new immunomodulation technology developed by YishengBio. Its proprietary PIKA technology augments both innate and adaptive immune responses through the TLR3, RIG-I and MDA5 pathways. With the PIKA immunomodulating technology platform, YishengBio has developed a series of new immune drugs and innovative vaccine products and has obtained over 60 patents for its PIKA immunomodulating technology across more than 30 countries and regions. Being able to accelerate post-exposure immune protection, PIKA rabies vaccine has the potential to lead in the rabies vaccines market in the future. The product has been cited as a novel vaccine by the World Health Organization and classified as a therapeutic biologics product by the China National Medical Products Administration. The product is planned to enter into its global multi-center Phase III clinical trial. Other products in clinical development include YS-ON-001 for the treatment of advanced solid tumors, YS-HBV-001 for hepatitis B and PIKA YS-SC2-010, a prophylactic and therapeutic vaccine candidate against Covid-19 virus. PIKA YS-HBV-002 for chronic HBV and PIKA YS-ON-002 for solid tumor, among others, are product candidates in preclinical and discovery stages.

"We are very pleased to have the support of healthcare investors in the Series B investment," said David Shao, CEO of YishengBio. "We believe their investments in YishengBio reflects the confidence in our development of novel PIKA immunomodulating technology, the revenue potential of YSJA rabies vaccine, and the market prospectus of our innovative vaccine pipeline. This new round of capital will accelerate the building of our management and R&D teams and will facilitate the growth of our pipeline and construction of production sites both at home and abroad. YishengBio is committed to providing more innovative, safer and more effective vaccines and biologics for doctors and patients all over the world."

Dave Chenn, CEO and Managing Partner of Oceanpine Capital, the lead investor on YishengBio’s series B investment, said, "The COVID-19 epidemic has triggered abrupt development in vaccine research around the globe, which has been a focus of our investment in healthcare sector. Specializing in the development of innovative vaccines and therapeutic biologics for infectious diseases and cancer, YishengBio boasts a management team of comprehensive and complementary capabilities in the vaccine industry and commercialization. The YSJA rabies vaccine is well received by the market as a quality product and the in-house developed competitive PIKA technology has been applied to the development of a new generation of antiviral vaccines. We are optimistic about the future of YishengBio. Oceanpine is very excited to be the lead investor in the Series B investment to grow and thrive with the company and partners, and to help accelerate YishengBio in becoming a world-leading biopharmaceutical company."

Iris Wang, Managing Director of Orbimed Asia-Pacific, said, "Chinese biotech companies are playing an increasingly significant role in the innovation era of the whole world. As an existing shareholder of YishengBio, we are very glad to support the company’s strategy in developing and commercializing innovative vaccines and therapeutic biologics once again and are very confident in the execution capability of the management team."

Xiao Zhang, Managing Director of CEC Capital, said, "We are delighted to support YishengBio’s seried B investment. Vaccines and healthcare sectors have long been the focus of global investment and YishengBio is well-sought after company in innovative vaccines and biologics. We recognized the talented management team and strong capability. We look forward to seeing new milestones by YishengBio after this investment."

ASLAN Pharmaceuticals Announces Private Placement of Ordinary Shares

On February 24, 2021, ASLAN Pharmaceuticals Limited (the "Company") reported that entered into a Securities Purchase Agreement (the "Purchase Agreement") with the purchasers named therein (the "Purchasers"), pursuant to which the Company agreed to sell to the Purchasers, in an unregistered offering, an aggregate of 25,568,180 Ordinary Shares, nominal value $0.01 per share ("Ordinary Shares") at a purchase price of $0.704 per share (the "Purchase Price"), which represents the closing sale price of the Company’s American Depositary Shares ("ADSs") on the Nasdaq Global Market on February 24, 2021 of $3.52 per ADS divided by five (the "Private Placement") (Press release, ASLAN Pharmaceuticals, FEB 24, 2021, View Source [SID1234575595]). Each ADS represents five Ordinary Shares. The Private Placement is expected to close on or about February 25, 2021 (the "Closing"), subject to customary closing conditions.

The Private Placement is expected to result in gross proceeds to the Company of approximately $18 million before deducting offering expenses.

The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission within 30 days after the Closing to register the Ordinary Shares, which will be represented by ADSs (collectively, the "Securities").

The Company has also agreed, among other things, to indemnify the Purchasers, their partners, members, officers and directors, and each person who controls such Purchasers, from certain liabilities and to pay certain expenses incurred by the Company in connection with the registration of the Securities.

The Private Placement is exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended as a transaction by an issuer not involving a public offering. The Purchasers have agreed to acquire the Ordinary Shares for investment only and not with a view to or for sale in connection with any distribution thereof.

Adaptive Biotechnologies Reports Fourth Quarter and Full Year 2020 Financial Results

On February 24, 2021 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Adaptive Biotechnologies, FEB 24, 2021, View Source [SID1234575583]).

"Adaptive’s launch of T-Detect COVID marks a pivotal moment in the diagnostic testing paradigm. We have now proven that it is possible to read how T cells detect disease in the blood and we are on a fast path to develop this product for many other indications," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "As we move into 2021, we are poised to execute on several key catalysts across all business areas that will accelerate our vision to power the age of immune medicine."

Recent Highlights

Revenues of $30.2 million for the fourth quarter and $98.4 million for the full year of 2020, representing a 25% increase and 16% increase, respectively, over the corresponding periods in 2019.
Clinical sequencing volume increased 41% to 4,539 clinical tests delivered in the fourth quarter of 2020, compared to the fourth quarter 2019 and ended the year with 15,216 clinical tests delivered, up 50% versus 2019.
Launched T-Detect COVID, first clinical T-cell based test for patients to confirm recent or prior COVID-19 infection. In final review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).
Extended collaboration agreement with Labcorp to enable broader access to our growing portfolio of immune-driven clinical diagnostic and research products.
Submitted a 510(k) application to the FDA for the use of clonoSEQ in blood for B-cell acute lymphoblastic leukemia (ALL) patients.
Fourth Quarter 2020 Financial Results

Revenue was $30.2 million for the quarter ended December 31, 2020, representing a 25% increase from the fourth quarter in the prior year. Sequencing revenue was $12.7 million for the quarter, representing an 8% decrease from the fourth quarter in the prior year. Development revenue was $17.5 million for the quarter, representing a 69% increase from the fourth quarter in the prior year.

Operating expenses were $74.4 million for the fourth quarter of 2020, compared to $48.4 million in the fourth quarter of the prior year, representing an increase of 54%.

Net loss was $44.6 million for the fourth quarter of 2020, compared to $20.6 million for the same period in 2019.

Adjusted EBITDA (non-GAAP) was a loss of $34.6 million for the fourth quarter of 2020, compared to a loss of $18.7 million for the fourth quarter of the prior year.

Full Year 2020 Financial Results

Revenue was $98.4 million for the year ended December 31, 2020, representing a 16% increase from the prior year. Sequencing revenue was $41.4 million in 2020, representing a 5% decrease from 2019. Development revenue was $56.9 million in 2020, representing a 37% increase from the prior year.

Operating expenses for 2020 were $251.2 million, compared to $163.5 million for 2019, representing an increase of 54%.

Net loss was $146.2 million in 2020, compared to $68.6 million in 2019.

Adjusted EBITDA (non-GAAP) was a loss of $119.6 million for 2020, compared to a loss of $57.5 million in the prior year.

Cash, cash equivalents and marketable securities was $806.8 million as of December 31, 2020.

2021 Financial Guidance

Management will provide the 2021 outlook during the conference call scheduled to discuss the 2020 financial results.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its fourth quarter and full year 2020 financial results after market close on Wednesday, February 24, 2021 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

Daiichi Sankyo and LYSA-LYSARC-CALYM Enter Research Collaboration for Valemetostat in Patients with Relapsed/Refractory B-Cell Lymphoma

On February 24, 2021 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and LYSA-LYSARC-CALYM reported that they have entered a strategic research collaboration to study valemetostat (DS-3201), Daiichi Sankyo’s potential first-in-class EZH1/2 dual inhibitor, in B-cell malignancies starting with a phase 2 study in patients with five subtypes of relapsed/refractory B-cell lymphoma (Press release, Daiichi Sankyo, FEB 24, 2021, https://www.businesswire.com/news/home/20210223006211/en/Daiichi-Sankyo-and-LYSA-LYSARC-CALYM-Enter-Research-Collaboration-for-Valemetostat-in-Patients-with-RelapsedRefractory-B-Cell-Lymphoma [SID1234575573]).

The collaboration brings together Daiichi Sankyo’s innovative science and the multidisciplinary expertise of the Lymphoma Study Association (LYSA), the Lymphoma Academic Research Organization (LYSARC) and the CALYM research consortium to conduct clinical and translational research that will build upon the ongoing phase 1 study of valemetostat in patients with relapsed/refractory non-Hodgkin lymphoma.1

Lymphoma is a heterogenous disease with more than 90 different subtypes and while new treatment advances have improved outcomes for some patients, management of relapsed/refractory B-cell lymphoma remains a major challenge.2 There are currently no dual EZH1/2 directed therapies approved for cancer treatment.

"We are pleased to join forces with Europe’s largest lymphoma research organization to advance and strengthen the development of valemetostat as a potential novel precision medicine for patients with relapsed/refractory B-cell lymphoma," said Arnaud Lesegretain, Vice President, Global Oncology Development, Alpha Portfolio, Daiichi Sankyo. "LYSA-LYSARC-CALYM together with Daiichi Sankyo have designed a phase 2 study that will enroll patients based on disease subtype and biomarkers in order to further evaluate safety and efficacy, and we are planning a comprehensive translational research program to answer important scientific questions relating to clinical utility, optimal patient selection and mechanisms of resistance."

"We are very happy to engage our cooperative group in a collaboration with Daiichi Sankyo for this promising development program with valemetostat targeting relevant epigenetic factors EZH2 and EZH1 in B-cell lymphomas," said Franck Morschhauser, Professor of Hematology in Lille, France and President of LYSA-LYSARC. "We believe that our extensive multidisciplinary and international expertise will help advance the science behind the novel mechanism of action and we look forward to playing a role in bringing this potential new medicine to patients with lymphoma."

About the Collaboration

Under the agreement, LYSA-LYSARC will execute a multi-center, non-randomized, open-label phase 2 study to evaluate the safety and efficacy of valemetostat in six cohorts of patients with relapsed/refractory B-cell lymphoma.

The study will enroll patients with diffuse large B-cell lymphoma (with and without an EZH2 mutation) that has progressed on at least one prior treatment; follicular lymphoma (EZH2 mutant and EZH2 wild-type), mantle cell lymphoma, and marginal zone lymphoma/other indolent lymphomas that have progressed on two or more prior treatments; and Hodgkin lymphoma that has progressed on three or more prior treatments including checkpoint inhibitors.

The primary endpoint of the study is best overall response rate determined by investigator assessment. Secondary endpoints include complete response rate, progression-free survival, duration of response, time to response and safety measures including adverse events. Exploratory endpoints include overall survival and measures of biomarker expression and treatment response. Pharmacokinetic endpoints will also be assessed.

The study will include approximately 140 patients at 22 sites in France and Belgium and is anticipated to initiate in 2021.

About EZH1 and EZH2

EZH1 (enhancer of zeste homolog 1) and EZH2 (enhancer of zeste homolog 2) enzymes are part of polycomb protein complexes that act through histone methylation to regulate gene expression.3 EZH1 and EZH2 are recurrently highly expressed or mutated in many hematologic malignancies.4 Epigenetic dysregulation of the methylation process is associated with suppression of genes that regulate cancer cell growth and proliferation.4 Research shows that both EZH1 and EZH2 have a role in hematologic cancer progression and that simultaneous inhibition would be effective in targeting the cancers.5 There are no dual EZH1/2 directed therapies approved for treatment of cancer.

About Valemetostat

Valemetostat (DS-3201) is a potential first-in-class small molecule oral EZH1/2 dual inhibitor currently in clinical development in the Alpha portfolio of Daiichi Sankyo for several hematologic cancers. Valemetostat targets epigenetic regulation by inhibiting both the EZH1 and EZH2 enzymes. Valemetostat has displayed antitumor activity in various hematological malignancies in preclinical models.5,6

The development program of valemetostat includes a pivotal phase 2 trial in patients with relapsed or refractory adult T-cell leukemia/lymphoma (ATL) in Japan; a phase 1 study in patients with several types of non-Hodgkin lymphomas (NHL) including B-cell lymphoma, adult T-cell leukemia-lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) in the U.S. and Japan; and a phase 1 study in patients with acute lymphocytic leukemia (ALL) and acute myeloid leukemia (AML) in the U.S.

In April 2019, valemetostat received SAKIGAKE Designation for the treatment of adult patients with relapsed or refractory PTCL by the Japan Ministry of Health, Labour and Welfare (MHLW).

Valemetostat is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About B-Cell Lymphoma

Lymphoma is the most common type of blood cancer.7 There were more than 627,000 new cases of lymphoma diagnosed globally and more than 283,000 deaths from the disease in 2020.8

There are more than 90 different lymphoma subtypes, which occur in varying frequencies in different geographic regions around the world.7 Most lymphomas originate in B-cell lymphocytes, with the most common types being diffuse large B-cell lymphoma (about 33 percent), follicular lymphoma (about 20 percent), mantle cell lymphoma (about 5 percent) and marginal zone lymphoma (5 to 10 percent).9 Treatment recommendations and prognosis vary for different subtypes of B-cell lymphoma.10 New treatment advances have improved outcomes for some patients with certain types of B-cell lymphoma, but management of relapsed or refractory lymphoma remains a major challenge and new and novel treatments are needed.2