On May 10, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the first quarter ended March 31, 2021, which were in line with its previously announced, preliminary first-quarter results (Press release, Veracyte, MAY 10, 2021, View Source [SID1234579573]). The company also provided an update on recent business progress.

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"We delivered strong financial results for the first quarter of 2021, with particular momentum in March, as our business continues to emerge from the COVID-19 pandemic," said Bonnie Anderson, chairman and chief executive officer of Veracyte. "On March 12, we completed our acquisition of Decipher Biosciences which, with its market-leading urologic cancer portfolio, expands our reach into 7 of the top 10 cancers in the U.S. and will accelerate revenue growth.

"Additionally, we are excited to unveil pivotal clinical validation data at ASCO (Free ASCO Whitepaper) for our Percepta Nasal Swab test for early lung cancer detection. We expect to launch it and the Percepta Genomic Atlas as part of our comprehensive lung cancer portfolio later this year. We also anticipate strengthening our global commercial footprint with the introduction of the Envisia classifier, for improved diagnosis of interstitial lung diseases, on the nCounter Analysis System by the end of this year."

First Quarter 2021 Financial Results

For the three months ended March 31, 2021, compared to the prior year (Decipher Biosciences one-time acquisition-related expenses in the first quarter of 2021 increased our operating expenses, net loss and net cash used in operations by $35.1 million and our net loss per share by $0.55):

Total Revenue was $36.7 million, including $3.8 million for urologic cancer testing, an increase of 18%;
Gross Margin was 66%;
Operating Expenses were $82.1 million. Operating Expenses, Excluding Cost of Revenue, were $69.7 million, including $35.1 million related to the acquisition of Decipher Biosciences;
Net Loss and Comprehensive Loss was $41.9 million, including $35.1 million of expenses related to the acquisition of Decipher Biosciences;
Basic and Diluted Net Loss Per Common Share was $0.66, including $0.55 per share attributable to the acquisition related expenses recorded in G&A;
Net Cash Used in Operating Activities was $40.6 million; and
Cash and Cash Equivalents were $324.1 million at March 31, 2021.
First Quarter 2021 and Recent Business Highlights

Commercial Growth:

Total genomic testing and product revenue was $36.1 million, an increase of 19%, compared to the first quarter of 2020.
Total genomic volume was 14,437 tests, an increase of 11%, compared to prior year, including 1,560 tests from Decipher Biosciences.
Continue to expect a mid-year Medicare coverage decision for Decipher Bladder test, which will allow us to leverage our urology sales footprint to accelerate commercial adoption.
Launched General Manager-based global structure, vertically aligning commercial teams within each clinical indication to provide enhanced focus and clinical expertise. Also added key new hires in marketing, managed care and international market access to support multiple new product launches and global expansion later this year.
Evidence Development and Pipeline Advancement:

Six abstracts for our pulmonology products accepted as posters at the American Thoracic Society (ATS) 2021 International Conference this month:
– Percepta Genomic Atlas – New data demonstrating the test’s ability to inform treatment decisions on the same sample used in diagnosis, in anticipation for product launch in Q4 2021.
– Envisia – New data from five abstracts demonstrates the test’s clinical utility and our ability to enable the CLIA lab-based test on the nCounter Analysis System, in anticipation of the test’s international launch later this year.
Six abstracts for our oncology tests accepted for the ASCO (Free ASCO Whitepaper) Annual Meeting in June, including:
– Percepta Nasal Swab – Pivotal, multicenter, double-blind clinical validation data for test to enable early lung cancer detection, setting the stage for anticipated product launch in 2H 2021.
– Decipher Prostate – Two abstracts, including an oral presentation showing test’s ability to identify African American men with higher likelihood of aggressive prostate cancer, will help further distinguish Decipher Prostate from other prostate cancer genomic tests.
– Afirma XA – New data demonstrate the test’s ability to identify patients with gene alterations who may benefit from targeted therapies – at the time of diagnosis.
Two abstracts presented as posters at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Virtual Congress 2021 meeting this month highlighted potential applications of the PAM50 biomarker on which the Prosigna test is based, as well as initial results from the PROCURE study, which aims to develop consensus around the use of breast cancer genomic tests, including Prosigna.
First patient enrolled and randomized in a study using Veracyte’s LymphMark lymphoma subtyping test to identify and enroll patients with untreated DLBCL who may benefit from Acerta Pharma and AstraZeneca’s Calquence in combination with a traditional chemoimmunotherapy regimen.
Financing:

Issued and sold 8,547,297 shares of common stock in February 2021, including 1,114,864 shares sold upon full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $74.00 per share. The net proceeds to Veracyte from the offering were approximately $593.8 million.
Veracyte used a portion of the net proceeds from the offering, together with its existing cash and cash equivalents, to finance its $600 million cash acquisition of Decipher, which was completed in March 2021. The company intends to use the remaining net proceeds of the offering for working capital and other general corporate purposes, which may include acquiring or investing in complementary businesses, technologies or other assets.
Additionally, in March 2021, the company announced the appointment of Muna Bhanji, a global senior healthcare executive, to its board of directors.

2021 Financial Outlook

Veracyte is reiterating its previous 2021 annual total revenue guidance of approximately $190 million to $200 million, representing growth of approximately 65% over 2020 at the midpoint of the range.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

On May 10, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended March 31, 2021 (Press release, ImmunoGen, MAY 10, 2021, View Source [SID1234579591]).

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"During the first quarter, we advanced our portfolio of innovative ADCs and accelerated preparations for two potential product launches next year," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "We saw a limited delay in patient enrollment in the pivotal SORAYA trial for our lead program, mirvetuximab soravtansine, which has shifted the anticipated timing of top-line data from the third into the fourth quarter of this year and the projected submission of the BLA into the first quarter of 2022. We have also experienced some COVID-related impact on accrual to our confirmatory MIRASOL trial and now expect the read-out on the primary endpoint to move from the second into the third quarter of 2022. Beyond SORAYA and MIRASOL, we are commencing several studies to move mirvetuximab into earlier lines of ovarian cancer therapy, including an investigator-sponsored trial of mirvetuximab in combination with carboplatin in the neoadjuvant setting that initiated this quarter. We are also supporting a randomized study comparing mirvetuximab combined with carboplatin to standard of care in patients with recurrent platinum-sensitive disease and have submitted a protocol to FDA for a single-arm study of mirvetuximab monotherapy in later-line platinum-sensitive patients, with both studies anticipated to begin enrollment in the second half of this year. Finally, we were pleased to receive notice that mature data from our mirvetuximab plus Avastin doublet cohort in recurrent ovarian cancer, regardless of platinum status, have been selected for an oral presentation at ASCO (Free ASCO Whitepaper) in June."

Enyedy added, "We continued enrollment for our second pivotal program, IMGN632, in patients with frontline and relapsed/refractory BPDCN, with top-line data expected in the first half of 2022. IMGN632 is also in ongoing development in AML, both as a monotherapy and in combinations. Moving to our earlier-stage portfolio, we presented preclinical data at AACR (Free AACR Whitepaper) last month on IMGC936, our first-in-class ADAM9-targeting ADC, demonstrating anti-tumor activity in multiple solid tumor models, and we advanced dose escalation in the Phase 1 study for this program. IND-enabling activities for our next-generation anti-FRα ADC, IMGN151, are on track to submit an application to the FDA by the end of 2021. With pre-commercial activities underway, we look forward to a meaningful year ahead with a number of important milestones across the business as we work towards bringing our first two therapies to market next year."

RECENT PROGRESS

Further enrolled patients in the pivotal SORAYA and confirmatory MIRASOL trials.
Supported initiation of an investigator-sponsored trial of mirvetuximab plus carboplatin in the neoadjuvant setting.
Submitted to the US Food and Drug Administration (FDA) a single-arm study protocol for mirvetuximab monotherapy in later-line platinum-sensitive ovarian cancer patients.
Advanced accrual of the pivotal 801 Phase 1/2 study of IMGN632 in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients.
Continued patient enrollment in the 802 Phase 1b/2 study of IMGN632 in combination with Vidaza (azacitidine) and Venclexta (venetoclax) in R/R and frontline acute myeloid leukemia (AML) patients and as a monotherapy in minimal residual disease positive (MRD+) AML.
Presented preclinical data on IMGC936, our novel ADAM9-targeting ADC in co-development with MacroGenics, in a poster at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
Moved through dose-escalation cohorts in the Phase 1 study of IMGC936 in multiple solid tumor types.
Progressed activities to support an investigational new drug (IND) application for IMGN151.
ANTICIPATED UPCOMING EVENTS

Generate top-line pivotal SORAYA data in the fourth quarter of 2021 and submit the biologics license application (BLA) in the first quarter of 2022 to support potential accelerated approval in 2022.
Complete patient enrollment in MIRASOL and generate top-line data in the third quarter of 2022.
Present mature data from the Phase 1b FORWARD II cohort evaluating mirvetuximab in combination with Avastin (bevacizumab) in recurrent ovarian cancer in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Initiate a single-arm study of mirvetuximab monotherapy in recurrent platinum-sensitive ovarian cancer in the second half of 2021 to support potential label expansion.
Support the start of a randomized Phase 2 investigator-sponsored study of mirvetuximab plus carboplatin in recurrent platinum-sensitive ovarian cancer in the second half of 2021.
Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Complete dose escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in early 2022.
Submit the IND application for IMGN151 by the end of 2021.
FINANCIAL RESULTS

Revenues for the quarter ended March 31, 2021 were $15.7 million, compared with $13.3 million for the quarter ended March 31, 2020, which consisted primarily of non-cash royalty revenues.

Operating expenses for the first quarter of 2021 were $44.6 million, compared with $37.1 million for the same quarter in 2020. The increase was largely driven by research and development expenses, which were $34.4 million in the first quarter of 2021, compared with $27.4 million for the first quarter of 2020. This increase was primarily due to greater clinical trial expenses driven by costs related to the MIRASOL, SORAYA, and IMGC936 studies, greater external manufacturing costs, and greater personnel and temporary staffing costs. General and administrative expenses for the first quarter of 2021 increased to $10.2 million, compared to $8.9 million for the first quarter of 2020, primarily due to increased professional fees and personnel costs, including greater stock-based compensation. Operating expenses for the first quarter of 2020 included a $0.8 million restructuring charge related to retention costs.

Net loss for the first quarter of 2021 was $34.1 million, or $0.17 per basic and diluted share, compared to a net loss of $29.1 million, or $0.17 per basic and diluted share, for the first quarter of 2020. Weighted average shares outstanding increased to 198.8 million for the 2021 period from 166.9 million in the prior year.

ImmunoGen had $283.1 million in cash and cash equivalents as of March 31, 2021, compared with $293.9 million as of December 31, 2020, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $44.6 million for the first three months of 2021, compared with cash used in operations of $28.3 million for the same period in 2020. Capital expenditures were $(0.9) million for the first quarter of 2021, compared with net proceeds from the sale of equipment of $1.4 million for the first quarter of 2020.

FINANCIAL GUIDANCE

ImmunoGen’s financial guidance for 2021 remains unchanged:

revenues between $65 million and $75 million;
operating expenses between $200 million and $210 million; and
cash and cash equivalents at December 31, 2021 to be between $140 million and $150 million.
ImmunoGen expects that its current cash will fund operations into the second half of 2022.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 9982696. The call may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.

On May 10, 2021 Promega Corporation reported that Serious runners and casual walkers alike are invited to join a month-long Get Your Rear in Gear – Madison run/walk virtual event during May to raise money and awareness for colorectal cancer screening efforts (Press release, Promega, MAY 10, 2021, View Source [SID1234579609]). Colorectal cancer is the nation’s No. 2 cancer killer, but it is up to 95% preventable with proper screening. The number of people being screened has dropped drastically worldwide since the start of the COVID-19 pandemic. The event is aimed to help encourage this important, life-saving health screening.

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"It is imperative that patients are encouraged to get back in with their primary doctor to get screening tests they may have missed," says Dr. Sam Lubner, an oncologist at the University of Wisconsin Carbone Cancer Center. "Without accurate diagnosis as early as possible, all of the advancements we have made in cancer research cannot be brought to bear for patients."

Get Your Rear in Gear – Madison is presented by Promega and Exact Sciences with the support of the Colon Cancer Coalition. This inaugural event is one of nearly 40 held annually across the country planned by local volunteers. Money raised will go to UW Carbone Cancer Center programs aimed at increasing colon cancer screening and early detection.

Registration is open during the entire month of May at www.ColonCancerCoalition.org/Madison. Event participation for colorectal cancer patients and survivors is free. Fundraising by participants is encouraged, but not required.

On May 10, 2021 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported financial results for the first quarter of 2021, along with recent product highlights and corporate updates (Press release, Zai Laboratory, MAY 10, 2021, View Source [SID1234579637]).

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"Zai Lab continued to execute well in all aspects of the business during the first quarter," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "We entered into several strategic collaborations to further strengthen our gastric and lung cancer disease strongholds; significantly bolstered our autoimmune franchise with an exclusive agreement with argenx for efgartigimod, a pipeline-in-a-product opportunity; advanced numerous clinical programs toward key data readouts; gained approval of QINLOCK by the National Medical Products Administration (NMPA), our third innovative oncology product approval in the last 15 months in China and the first commercial product in what we expect to become a world-class gastric cancer franchise; and generated solid revenue growth, in part from increased volume of ZEJULA driven by its recent inclusion on the National Reimbursement Drug List (NRDL). In addition, we recently received encouraging news on several key assets from our partners. The Biologics License Application (BLA) filing of efgartigimod in generalized myasthenia gravis (gMG) was accepted by the U.S. Food and Drug Administration (FDA). The Phase 3 pivotal LUNAR trial of Tumor Treating Fields in non-small cell lung cancer (NSCLC) was recommended to continue with reduced sample size based on an accelerated interim analysis. Bemarituzumab was granted Breakthrough Therapy Designation by the FDA as first-line treatment for gastric cancer patients who overexpress FGFR2b.

"With the completion of our recent global public offering with gross proceeds of nearly $860 million, we significantly strengthened our capital position. This new capital will allow us to accelerate our growth by entering into additional strategic partnerships, advancing our clinical development pipeline, and scaling our commercial and R&D organizations to drive strong revenue growth and enhance our global pipeline.

"We remain on target to advance all stages of our product pipeline throughout 2021. We continue to expect approval of Nuzyra for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) by the NMPA. We plan to file margetuximab for Her2-positive breast cancer, Tumor Treating Fields for mesothelioma and ZEJULA for late-line ovarian cancer in China. We are engaging with the NMPA on the regulatory filing strategy for efgartigimod in gMG in China. And we anticipate numerous data readouts, including for Tumor Treating Fields in liver cancer and ovarian cancer, for QINLOCK in second-line GIST, for margetuximab in gastric cancer, for CLN-081 in NSCLC and for TPX-0022 in NSCLC and gastric cancer.

"In our mission to address serious unmet medical needs for patients in China and around the world, we believe that we have built a sustainable platform that we can leverage," Dr. Du concluded. "Our team continues to deliver on our aggressive growth objectives. I believe that the future of Zai Lab has never been brighter."

Recent Product Highlights and Anticipated Milestones

Oncology

ZEJULA (niraparib)

ZEJULA is an oral, once-daily small-molecule poly ADP-ribose polymerase (PARP) 1/2 inhibitor. It is the only PARP inhibitor approved in the United States, the European Union and mainland China (hereinafter, "China") as a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.

Anticipated 2021 Zai Milestones

Complete enrollment of the Phase 1b study of ZEJULA in combination with tebotelimab (PD-1 x LAG-3) in gastric cancer.

Announce topline results of the Phase 3 PRIME study of ZEJULA in patients with first-line ovarian cancer in China in the second half.

Submit the supplemental New Drug Application (sNDA) for late-line ovarian cancer treatment in the second half.

Continue to explore additional indications and combination opportunities.
Tumor Treating Fields

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cell death.

Recent Product Highlights

In April 2021, Zai Lab partner Novocure announced an update regarding its Phase 3 pivotal LUNAR trial in stage 4 NSCLC following failure on platinum-based chemotherapy. After a review by an independent data monitoring committee (DMC), Novocure was informed by the committee that the pre-specified interim analysis for the LUNAR trial had been accelerated given the length of accrual and the number of events observed. The DMC concluded that it is likely unnecessary and possibly unethical for patients randomized to the control arm to continue accrual to 534 patients with 18 months follow-up. The DMC further recommended a reduced sample size of approximately 276 patients with 12 months follow-up. Novocure has filed an IDE supplement with the FDA and is awaiting the agency’s response.

Zai Lab has initiated the LUNAR trial in Greater China and will help accelerate the development of Tumor Treating Fields for NSCLC and other cancer patients worldwide.
Anticipated 2021 Zai Milestones

Submit a Marketing Authorization Application (MAA) for malignant pleural mesothelioma.

Join the global Phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer, the Phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer and the Phase 3 pivotal METIS trial in brain metastases from non-small cell lung cancer.

Complete enrollment of the Phase 2 pilot trial in first-line gastric adenocarcinoma.
Anticipated 2021 Partner Milestones

Receive FDA response to IDE supplement incorporating recommended protocol changes to the Phase 3 pivotal LUNAR trial in NSCLC in the second quarter.

Obtain final data from the Phase 2 HEPANOVA trial in advanced liver cancer in the second quarter.

Complete the interim analysis of the Phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer in the second half.
QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and PDGFRα-mutated kinases. It is the only therapeutic approved in the United States for advanced GIST patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.

Recent Product Highlight

In March 2021, Zai Lab announced that the NMPA approved its New Drug Application (NDA) for QINLOCK for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. This approval is the third innovative oncology product approval Zai Lab has received in the last 15 months in China.
Anticipated 2021 Zai Milestones

Commercial launch of QINLOCK for the treatment of fourth-line GIST in May, 2021.

Obtain regulatory approval in Taiwan in the second half.
Anticipated 2021 Partner Milestones

Obtain topline data from the INTRIGUE Phase 3 study of QINLOCK in patients with second-line GIST in the fourth quarter.
Odronextamab

Odronextamab is a bispecific monoclonal antibody designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).

Anticipated 2021 Zai Milestone

Enroll the first patient in Greater China in the global Phase 2 potentially pivotal program, subject to feedback from the FDA.
Anticipated 2021 Partner Milestones

Resume enrollment of the Phase 2 potentially pivotal program in B-cell non-Hodgkin lymphoma (B-NHL) in the second quarter, pending FDA approval of the updated protocol.

Initiate confirmatory OLYMPIA Phase 3 trials in combination with chemotherapy in follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), and explore other combination opportunities.

Initiate development of a subcutaneous formulation.
Repotrectinib

Repotrectinib is a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A/B/C, with the potential to treat TKI-naïve or TKI-pretreated patients.

Anticipated 2021 Zai Milestone

Enroll the first patient in Greater China in the global TRIDENT-1 Phase 2 registrational study in the second quarter.
Anticipated 2021 Partner Milestones

Reach target enrollment of the ongoing TRIDENT-1 study in the ROS1-positive TKI-naïve NSCLC patient cohort. An FDA meeting is anticipated during the first quarter of 2022 to discuss topline blinded independent central review (BICR) results.

Initiate TRIDENT-2, a Phase 1b/2 combination study in KRAS-mutant solid tumors, mid-year.

Provide a clinical data update from the ongoing TRIDENT-1 study in the second half.

Report initial clinical data from the Phase 1/2 CARE study in pediatric and young adult patients in the second half.
MARGENZA (Margetuximab)

MARGENZA is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2).

Anticipated 2021 Zai Milestone

Submit an NDA for pretreated metastatic HER2-positive breast cancer.
Anticipated 2021 Partner Milestones

Obtain initial data from Module A of the MAHOGANY study in the third quarter.

Complete the final overall survival analysis of the SOPHIA study, a randomized, open-label Phase 3 study evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer who have previously been treated with HER2-targeted therapies, in the third quarter.
Bemarituzumab

Bemarituzumab is a first-in-class antibody that is being developed in gastric and gastroesophageal junction cancer as a targeted therapy for tumors that overexpress FGFR2b.

Recent Product Highlight

In April 2021, the FDA granted Breakthrough Therapy Designation for bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2- (HER2-) negative metastatic and locally advanced gastric and gastroesophageal junction adenocarcinoma in combination with modified FOLFOX 6, based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b.
Anticipated 2021 Zai Milestone

Initiate a pivotal Phase 3 trial in gastric cancer.
CLN-081

CLN-081 is an orally available, small-molecule, next-generation, irreversible epidermal growth factor receptor (EGFR) inhibitor designed to selectively target cells expressing mutant EGFR variants, including EGFR exon 20 insertions.

Anticipated 2021 Zai Milestone

Enroll the first patient in Greater China in the global potentially pivotal study in the second half.
Anticipated 2021 Partner Milestone

Provide a clinical data update from the Phase 1/2a global study.
TPX-0022

TPX-0022 is an orally bioavailable, multi-targeted kinase inhibitor with a novel three-dimensional macrocyclic structure that inhibits the MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinases.

Anticipated 2021 Partner Milestones

Provide a clinical data update from the Phase 1 SHIELD-1 study and initiate the Phase 2 portion of the SHIELD-1 study in the second half, pending FDA feedback.

Initiate SHIELD-2, a Phase 1b/2 combination study with an EGFR targeted therapy, in the second half.
Tebotelimab

Tebotelimab is an investigational, first-in-class, bispecific, tetravalent DART molecule targeting PD-1 and LAG-3.

Anticipated 2021 Zai and Partner Milestone

Provide a clinical update, including future development plans.
Retifanlimab

Retifanlimab is an investigational monoclonal antibody that inhibits PD-1.

Recent Product Highlight

In January 2021, our partner Incyte announced that the FDA had accepted for Priority Review its BLA for retifanlimab in patients with pretreated advanced squamous cell anal cancer (SCAC), with a Prescription Drug User Fee Act (PDUFA) date of July 25, 2021.
Autoimmune Diseases

Efgartigimod

Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation.

Recent Product Highlight

Five Clinical Trial Applications (CTAs) accepted by the NMPA.
Anticipated 2021 Zai Milestones

Discuss with the NMPA a potential accelerated regulatory pathway for efgartigimod in gMG.

Continue to explore and advance additional indications in coordination with argenx.
Receive CTA approvals for additional indications.
Anticipated 2021 Partner Milestones

Potential FDA approval with a PDUFA target action date of December 17, 2021, and global commercial launch of efgartigimod for the treatment of patients with gMG.

Continue enrollment of the registrational ADHERE trial in chronic inflammatory demyelinating polyneuropathy (CIDP).

Initiate clinical trials in fifth and sixth indications.
Infectious Disease

NUZYRA (omadacycline)

NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with CABP and ABSSSI.

Anticipated 2021 Zai Milestone

Potential NMPA approval and commercial launch of NUZYRA for the treatment of CABP and ABSSSI.
Sulbactam-Durlobactam (SUL-DUR)

Sulbactam-Durlobactam is a beta-lactam/beta-lactamase inhibitor combination that provides unique activity against Acinetobacter organisms, including carbapenem-resistant strains.

Anticipated 2021 Zai and Partner Milestone

Complete patient enrollment in the global Phase 3 ATTACK trial, with a top-line data readout anticipated in the second half.
Internal Programs with Global Rights

ZL-2309 (CDC7)

ZL-2309 is an orally active, selective and ATP-competitive cell division cycle 7 (CDC7) kinase inhibitor.

Anticipated 2021 Zai Milestone

Initiate a biomarker-driven POC study in selected tumors.
ZL-1102 (IL-17)

ZL-1102 is a novel human nanobody targeting IL-17 with high affinity and avidity. Unlike other anti-IL-17 products, ZL-1102 is being developed as a topical treatment for chronic plaque psoriasis (CPP).

Anticipated 2021 Zai Milestone

A top-line data readout is anticipated in the second half.
Business Development Updates

In January 2021, Zai Lab announced an exclusive license agreement with argenx for the development and commercialization of efgartigimod in Greater China. Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process, with potential application in myasthenia gravis, pemphigus vulgaris, immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy and several additional indications.

In January 2021, Zai Lab expanded its collaboration with Turning Point Therapeutics with an exclusive license agreement for the development and commercialization of TPX-0022 in Greater China. TPX-0022 is a multi-targeted kinase inhibitor that targets MET, SCF1R and SRC kinases, with potential uses in treating advanced or metastatic solid tumors.
Corporate Updates

In April 2021, Zai Lab announced the closing of a global offering of American depositary shares and ordinary shares, including the full exercise of the greenshoe option, for total gross proceeds to Zai Lab of $857.5 million. This offering was the first ever dual-tranche offering on both NASDAQ and the Hong Kong Stock Exchange.

ZEJULA has been listed in 67 commercial health insurance plans and 52 supplemental insurance plans initiated by provincial or municipal governments since its commercial launch in January 2020 in China. Optune has also been listed in 13 supplemental insurance plans since its commercial launch in June 2020 in China.

On May 7, 2021, Tao Fu took a new role as Chief Strategy Officer of Zai Lab, and transitioned out of his roles as President and Chief Operating Officer and resigned from the Board of Directors of Zai Lab, in order to focus on Zai Lab’s corporate development and other strategic objectives.

Zai Lab continues to expand and hire talented professionals. As of April 15, 2021, Zai Lab employed 1,354 full-time employees, including 514 and 683 employees engaged in R&D and commercial activities, respectively.
First-Quarter 2021 Financial Results

For the three months ended March 31, 2021, net product revenues were $20.1 million, compared to $8.2 million for the same period in 2020. Revenues for the period were comprised of $12.6 million for ZEJULA, compared to $6.3 million for the same period in 2020; and $7.1 million for Optune, compared to $1.9 million for the same period in 2020.

Research and Development (R&D) expenses were $203.9 million for the three months ended March 31, 2021, compared to $33.7 million for the same period in 2020. The increase in R&D expenses was primarily attributable to a $62.3 million upfront payment in Zai Lab equity (fair value of the shares on the closing date of the agreement due to certain restrictions) and a $75 million development cost-sharing payment to argenx; a $25 million upfront payment to Turning Point; expenses related to ongoing and newly initiated late-stage clinical trials; and payroll and payroll-related expenses from increased R&D headcount.

Selling, General and Administrative expenses (SG&A) were $35.8 million for three months ended March 31, 2021, compared to $18.7 million for the same period in 2020. The increase was primarily due to payroll and payroll-related expenses from increased commercial headcount and related costs, as Zai Lab continued to expand its commercial operations in China.

For the three months ended March 31, 2021, Zai Lab reported a net loss of $232.9 million, or a loss per share attributable to common stockholders of $2.64, compared to a net loss of $48.0 million, or a loss per share attributable to common stockholders of $0.66, for the same period in 2020. The increase in the net loss was primarily attributable to payments related to new business development activities with argenx and Turning Point recorded in R&D expenses.
As of March 31, 2021, cash and cash equivalents, short-term investments and restricted cash totaled $1,014.2 million compared to $1,187.5 million as of December 31, 2020. In addition, in April 2021, Zai Lab announced the closing of a global follow-on offering. The expected total proceeds to Zai Lab, including both the American depositary shares offering and the ordinary shares offering, net of underwriting fees and other offering expenses, are approximately $818.1 million.
Conference Call and Webcast Information

Zai Lab will host a live conference call and webcast today, May 10, 2021, at 8:00 a.m. ET. Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call. Details are as follows:

Registration Link: View Source

Conference ID: 2374839

All participants must use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive a dial-in number, Direct Event passcode and a unique access PIN, which can be used to join the conference call.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website at View Source

On May 9, 2021 Grand Pharmaceutical and Healthcare Holdings Limited reported that the core product SIR-Spheres Y-90 resin microspheres of Sirtex Medical Pty Ltd ("Sirtex"), an associate company of the Group, has been successfully completed the first patient administration recently, following the approval by the US Food and Drug Administration ("FDA") to conduct a clinical trial for hepatocellular carcinoma ("HCC") (Press release, Grand Pharmaceutical, MAY 9, 2021, View Source [SID1234653971]).

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Sticking to patients-centered and innovation-driven, the Group will continue to expand its strategic planning in anti-tumor field and increase its investment in the world-class innovative products in the fields of radiopharmaceuticals and precision interventional therapy. The Group will continue to introduce world-class innovative products for different cancer indications in response to unmet clinical needs and enrich product pipeline and improve supply chain, dedicating itself into building world-leading radiopharmaceuticals platform and anti-tumor platform integrating diagnostics and treatment. The Group adopts the strategy of "global expansion and dual-cycle operation", forming a new pattern of domestic and international cycles that synergize with each other.

The SIR-Spheres Y-90 resin microspheres clinical study, DOORwaY90, is being conducted in the United States to evaluate the safety and efficacy of SIR-Spheres Y-90 resin microspheres as a first-line treatment for patients with unresectable or inoperable HCC patients in order to obtain approval for the HCC indication in the United States. The study will be conducted at 15 oncology centers, led by MD Anderson Cancer Center, and will enroll 100 patients in an open-arm study. The primary clinical endpoints will be the overall response rate (ORR) and duration of response (DoR). DOORwaY90 will be the first U.S. registration trial to utilize and delineate personalized dosimetry treatment planning and to define actionable post-treatment dosimetric verification for endpoint assessment, further providing high-quality supporting data for the use of SIR-Spheres Y-90 resin microspheres in HCC patients to benefit more HCC patients.

SIR-Spheres Y-90 resin microspheres is a targeted internal radionuclide product for liver malignant tumors, applying the world’s leading interventional technology is used to inject SIR-Spheres Y-90 resin microspheres into the blood vessels of liver tumors and release high-energy beta radiation to kill tumor cells. In 2002, this product was approved by the U.S. FDA for the treatment of unresectable colorectal cancer liver metastases (mCRC) based on the pivotal research CRI9101 (n=74), and in the same year it was approved by the European Union for the treatment of unresectable advanced liver malignancies.

SIR-Spheres Y-90 resin microspheres have been given to over 100,000 people in over 50 countries and regions around the world. With its remarkable clinical efficacy, it is recommended for treatment of hepatic malignant tumors by many authoritative guidelines, including National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper). It is also covered by medical insurance in places such as the United States and Europe. In addition, it is included in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition) and Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis (2018 edition) , delineating clear clinical demands.

The registration of SIR-Spheres Y-90 resin microspheres in China is progressing smoothly. In August 2020, the National Medical Products Administration of the PRC was approved to file the new drug application for the treatment of colorectal liver metastases based on clinical trial data obtained overseas. The new drug application was accepted in November, 2020.

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, "The successful completion of the first patient administration of SIR-Spheres Y-90 resin microspheres is an important progress made by the Group in the field of tumor treatment, laying the foundation for benefiting more liver cancer patients worldwide in the future. Looking ahead, the Group will make full use of its domestic industrial advantages and research and development capabilities, to accelerate commercialization process for innovative products and provide cancer patients with more advanced and diverse treatment options in the world."