On September 10, 2020 Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, reported that the China National Medical Products Administration (NMPA) has approved its supplemental New Drug Application (sNDA) for ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy (Press release, Zai Laboratory, SEP 10, 2020, View Source [SID1234564931]).

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"We believe ZEJULA is a potential best-in-class PARP inhibitor. It is the first and only PARP inhibitor approved anywhere globally, including in China as monotherapy for all-comer patients in the first-line and recurrent maintenance treatment settings," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. "The NMPA’s rapid approval of our sNDA for ZEJULA underscores the unmet medical needs it serves and further enables Zai Lab to make a meaningful impact on the way ovarian cancer is treated in China."

"The approval of ZEJULA for the first-line maintenance treatment setting represents an opportunity to fundamentally change how women with ovarian cancer will be treated in China and a new standard of care for these patients," said Dr. Lingying Wu, Director of the Department of Gynecologic Oncology of the Cancer Hospital of China Academy of Medical Sciences. "In addition to its compelling efficacy data as monotherapy for all-comer patients, ZEJULA also has the convenience of once-daily dosing, excellent safety profile and attractive pharmacokinetic properties, including its ability to cross the blood brain barrier."

ZEJULA’s sNDA for the first-line maintenance treatment setting was accepted by the NMPA in March 2020, and was granted priority review status in April 2020.

About Ovarian Cancer

Ovarian cancer is one of the most common gynecologic cancers in China with approximately 52,000 newly diagnosed cases and 23,000 deaths in China per year. While platinum-based

chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. Effective treatment options for patients with platinum-sensitive recurrent ovarian cancer remain limited. New agents that prolong the duration of response following platinum-based treatment and delay the inevitable relapse of ovarian cancer will benefit patients with ovarian cancer in China.

About ZEJULA (Niraparib)

ZEJULA (niraparib) is indicated as monotherapy for the maintenance treatment of adult patients with advanced and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first and second-line platinum-based chemotherapy.

The PRIMA study conducted by Zai Lab’s partner GlaxoSmithKline plc (GSK) demonstrated significant progression-free survival (PFS) improvement when given as monotherapy in women with first-line platinum responsive ovarian cancer, resulting in a 38% reduction in the risk of disease progression or death in the overall study population. Clinically meaningful reduction in risk of disease progression or death was further demonstrated with hazard ratios (HRs) of 0.40, 0.43 and 0.68 for BRCA mutant, HRD positive and HRD negative tumors, respectively. This study showed ZEJULA as the first PARP inhibitor to significantly improve PFS in this setting, regardless of biomarker status.

Zai Lab has several studies ongoing or completed in Chinese patients with ovarian cancer:

In November 2019, Zai Lab completed patient enrollment of its self-sponsored Phase III PRIME study evaluating ZEJULA as a first-line maintenance therapy in ovarian cancer patients who are in a complete or partial response to first-line platinum-based chemotherapy.

In May 2020, Zai Lab announced positive top-line results from its self-sponsored Phase III NORA study of ZEJULA as maintenance therapy for Chinese patients with platinum-sensitive, recurrent ovarian cancer. The full results from the NORA study will be presented at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2020 Virtual Congress on September 19, 2020.

In August 2020, the first patient was dosed in the registrational bridging trial for late-line ovarian cancer treatment.

Zai Lab also conducted a Phase I pharmacokinetic (PK) study of ZEJULA in Chinese patients with ovarian cancer.

ZEJULA is also being evaluated in China in a Phase Ib dose escalation and expansion clinical study, in combination with tebotelimab (PD-1 x LAG-3 DART molecule) for the treatment of patients with advanced or metastatic gastric cancer who failed prior treatment.

Zai Lab has a collaboration, development and license agreement with GSK for the development and commercialization of ZEJULA in Mainland China, Hong Kong and Macau.

Important Safety Information

The most common side effects for patients taking ZEJULA include heart not beating regularly, nausea, constipation, vomiting, pain in the stomach area, mouth sores, diarrhea, indigestion or heartburn, dry mouth, tiredness, loss of appetite, urinary tract infection, shortness of breath,

cough, rash, changes in liver function or other blood tests, pain in your joints, muscles, and back, headache, dizziness, change in the way food tastes, trouble sleeping, anxiety, sore throat and changes in the amount or color of your urine. Other potential serious side effects include bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML), symptoms of low blood cell counts (which can be a sign of serious bone marrow problems) and high blood pressures. Patients should take a few medical tests before they are treated with ZEJULA. Healthcare providers should periodically monitor their patients’ blood cell counts and blood pressures.

On September 10, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that members of management will present virtually at the H.C. Wainwright & Co. 22nd Annual Global Investment Conference on September 14th and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22nd (Press release, Moleculin, SEP 10, 2020, View Source [SID1234564930]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

H.C. Wainwright 22nd Annual Global Investment Conference:
Date: Monday, September 14th, 2020
Time: 5:00 PM ET
Link: View Source

Oppenheimer Fall Healthcare Life Sciences & MedTech Summit:
Date: Tuesday, September 22nd, 2020
Time: 10:00 AM ET
Link: View Source

Replays of the presentations will be available on the Company’s website for 90 days following the event. Members of management will hold 1-on-1 virtual investor meetings at the conferences. Investors attending the conferences virtually who are interested in meeting with Company management should contact their H.C Wainwright and Oppenheimer representatives.

On September 10, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Kenneth C. Frazier, chairman and chief executive officer, and Dr. Roger M. Perlmutter, president, Merck Research Laboratories, are scheduled to participate in a virtual fireside chat at the Morgan Stanley 18th Annual Conference on Sept. 15, 2020, at 9:30 a.m. EDT (Press release, Merck & Co, SEP 10, 2020, View Source [SID1234564929]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

On September 10, 2020 VBL Therapeutics (Nasdaq: VBLT) reported that the first two patients have been enrolled in the Phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo), an immune checkpoint inhibitor, for the treatment of metastatic colorectal cancer (Press release, VBL Therapeutics, SEP 10, 2020, View Source [SID1234564928]). The study is being conducted under a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute (NCI) and VBL.

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"Colon cancer is one of the most common cancers worldwide, but immune-based approaches in gastrointestinal cancers have unfortunately been largely unsuccessful," said Tim F. Greten, M.D., Deputy Branch Chief & Senior Investigator of the Thoracic and GI Malignancies Branch (TGMB), Co-Director of the NCI Center for Cancer Research (CCR) Liver Cancer Program, and the principal investigator of the study. "The reasons for this are unclear, but no doubt relate to the fact that, in advanced disease, GI cancer appears to be less immunogenic. The goal of this Phase 2 study is to investigate whether priming with VB-111 followed by the addition of nivolumab may induce anti-tumor immune response in metastatic colorectal cancer, for which there remains a major unmet need."

"We are pleased to see beginning of enrollment in this study, despite the challenges of COVID-19," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We look forward to collaborating with the NCI on investigating VB-111 for the potential benefit of patients with colorectal cancer."

For additional information on the study refer to View Source

For patients interested in enrolling in this clinical study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the Web site: View Source

On September 10, 2020 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (NASDAQ: ANPC), a biotechnology company with operations in China and the United States, reported its financial results for the six months ended June 30, 2020 (Press release, Anpac Bio, SEP 10, 2020, View Source [SID1234564926]).

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Financial Highlights for the First Six Months of 2020

Total revenues were RMB4.1 million (US$0.6 million) for the first six months of 2020, an increase of 3.4% from RMB3.9 million for the first six months of 2019.
Gross margin was 45.3% for the first six months of 2020, an increase of 3.9 percentage points from 41.4% for the first six months of 2019.
The average selling price ("ASP") of CDA-based tests increased by RMB228, or 114% from the first six months of 2019 to the same period of 2020 primarily due to higher pricing for new contracts and a more favorable distributor mix.
Net loss was RMB56.1 million (US$7.9 million) for the first six months of 2020, compared to net loss of RMB34.9 million for the first six months of 2019. The net loss for the first six months of 2020 was due in part to one-time charges and expenses of RMB19.4 million related to the Company’s initial public offering ("IPO") and non-cash share-based compensation of RMB17.5 million.
Debt has been dropped significantly (a decrease of approximately 84%) compared to the end of last year (December 31, 2019).
Business Highlights for the First Six Months of 2020

The Company successfully listed on the NASDAQ stock exchange on January 30, 2020
The San Jose, California US lab received the College of American Pathologists ("CAP") certification. The lab also began to validate a COVID-19 antibody test on a major supplier’s FDA emergency use approved instrument and expects to commercialize the test in the second half of the year.
The Philadelphia, Pennsylvania US lab completed renovations and the 1st phase of instrument installation was finalized.
Two new products were launched, including a proprietary immunology test named ADME (AnPac Defense Medical Examination) and a new cancer test package named APCS (AnPac Pan Cancer Screening) combining CDA technology with ct-DNA methods.
Company continued to receive validation on the efficacy of CDA testing through study follow-ups. As of June 30, 2020, AnPac Bio had contacted over 22,393 tested individuals in China and received substantive feedback regarding health conditions and disease development from 13,488 individuals.
As of June 30, 2020, the Company filed 238 patent applications globally; among these, 128 patents have been granted.
The Company continued to build a cancer risk assessment database, which totaled approximately 180,500 samples as of June 30, 2020, including approximately 137,200 samples from commercial CDA-based tests and approximately 43,300 samples from research studies.
Dr. Chris Yu, AnPac Bio’s Chairman and CEO commented: "We have accomplished a number of critical milestones in the first half of the year, including its successful listing on the NASDAQ Global Markets, the launch of two new products, such as our AnPac Defense Medical Examination immunology test. We have continued to work in obtaining the Class III medical device certification in China and laboratory developed test (LDT) designation in the US. We have improved our financial performance with increased revenue, gross margin and average selling price, and reduced our operating loss, with additional cost-cutting measures to take effect during the second half of the year. The above milestones were achieved despite the outbreak of COVID-19 in the period. Looking ahead, we are optimistic about further revenue growth and gross profit increases, and new test qualification and launches in the second half of the year and in future."

Financial Results for the First Six Months of 2020

Revenue

Total revenues increased by 3.4% to RMB4.1 million (US$ 0.6 million) for the first six months of 2020 from RMB3.9 million for the first six months of 2019, primarily due to an increase in our ASP for the sales of cancer screening and detection tests.

Cost of Revenues

Cost of revenues decreased by 3.5% to RMB2.2 million (US$0.3 million) for the first six months of 2020 from RMB 2.3 million for the first six months of 2019. The decrease was primarily attributable to the Company’s streamlining of various staffing functions and less staff costs following the Chinese government’s stimulus policies in light of the COVID-19 pandemic. The decrease in our cost of revenues was also attributable to a decrease in outsourced testing expenses, as we performed more tests in our own labs.

Gross Profit and Gross Margin

Gross profit increased by 13.1% to RMB1.8 million (US$0.3 million) for the first six months of 2020 from RMB1.6 million for the first six months of 2019. Gross margin was 45.3% for the first six months of 2020, an increase of 3.9 percentage points from 41.4% for the first six months of 2019.

Selling and Marketing Expenses

Selling and marketing expenses decreased by 24.0% to RMB4.7 million (US$0.7 million) for the first six months of 2020 from RMB6.1 million for the first six months of 2019, primarily due to less share-based compensation.

Research and Development Expenses

Research and development expenses increased by 64.4% to RMB7.4 million (US$1.1 million) for the first six months of 2020 from RMB4.5 million for the first six months of 2019, primarily due to increased research activities under one of our research projects.

General and Administrative Expenses

General and administrative expenses increased by significantly to RMB50.7 million (US$7.2 million) for the first six months of 2020 from RMB24.0 million for the first six months of 2019, primarily due to higher professional service fees, which were primarily related to our IPO.

Interest Expenses

Interest expenses decreased by 59.7% to RMB517,000 (US$73,000) for the first six months of 2020 from RMB1,284,000 for the first six months of 2019, primarily due to our repayment of the short-term loans that were incurred prior to our IPO.

Other Income, Net

Net other income increased by significantly to RMB7.3 million (US$1.0 million) for the first six months of 2020 from RMB0.8 million for the first six months of 2019, primarily due to the reversal in fair value of the convertible loans that we borrowed from Zhijun after we repaid these loans.

Net Loss

Net loss was RMB56.1 million (US$7.9 million) for the first six months of 2020, compared to net loss of RMB34.9 million for the first six months of 2019. Basic and diluted loss per share was RMB5.12 (US$0.72) for the first six months of 2020, compared to that of RMB4.03 for the first six months of 2019.

Balance Sheet

As of June 30, 2020, the Company had cash and cash equivalents of RMB10.0 million (US$1.4 million), compared to RMB6.1 million as of December 31, 2019.

Cash Flow

Net cash used in operating activities was RMB53.9 million (US$7.6 million) for the first six months of 2020, compared to RMB22.2 million for the first six months of 2019.

Net cash used in investing activities was RMB1.2 million (US$0.2 million) for the first six months of 2020, compared to RMB0.4 million for the first six months of 2019.

Net cash provided by financing activities was RMB58.9 million (US$8.3 million) for the first six months of 2020, compared to RMB20.9 million for the first six months of 2019.

Conference Call

The Company’s management will host an earnings conference call at 8:00 am Eastern Time on September 10, 2020 (5:00 am Pacific Time/8:00 pm Beijing Time) to discuss the financial results for the first six months ended June 30, 2020. To attend this earnings conference call, please use the information below for either dial-in access or webcast access. When prompted, please reference "AnPac Bio/ANPC."

Conference Call
Date: September 10, 2020
Time: 8:00 am ET, U.S.
International Toll Free: United States: +1 888-346-8982

Mainland China: +86 400-120-1203

Hong Kong: +852 800-905-945
International: International: +1 412-902-4272
Conference ID: AnPac Bio-Medical Science Co., Ltd.
Please dial in at least 15 minutes before the commencement of the call to ensure timely participation. For those unable to participate, an audio replay of the conference call will be available from approximately one hour after the end of the live call until September 17, 2020. The dial-in for the replay is +1 877-344-7529 within the United States or +1 412-317-0088 internationally. The replay access code is 10147575.

A live webcast of the call will also be available at View Source