Zai Lab Announces First Quarter 2022 Financial Results and Corporate Updates – GlobeNewswire

| Source: Zai Lab Limited Zai Lab Limited
Pudong District, CHINA
SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., May 10, 2022 (GLOBE NEWSWIRE) — Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced financial results for the first quarter of 2022, along with recent product highlights and corporate updates.

“Our first-quarter results reflect Zai’s solid foundation and track record of consistent execution, and were marked by progress across the entire portfolio,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “Today, Zai’s broad, proprietary pipeline consists of 11 assets with global rights. Building upon last year’s proof of concept achievement for ZL-1102, our anti-IL-17A Humabody® for chronic plaque psoriasis, Zai recently unveiled preclinical data from four key oncology programs at the 2022 AACR Annual Meeting. With these assets just beginning to enter first-in-human and proof-of-concept clinical studies, we are in the exciting early days of demonstrating Zai’s commitment to its in-house discovery and translational research. And of course, this proprietary pipeline complements the advancements within our later-stage partnered pipeline, which is expected to produce numerous pivotal study readouts throughout 2022.”
“At the beginning of this year, we established 2022 strategic priorities that aim to position Zai to lead the next wave of biopharma innovation. I am pleased to say we continue to progress toward achieving these priorities, including progress toward filing the NDA for efgartigimod in China in mid-2022, initiation of a registrational study for bemarituzumab in first-line gastric cancer in Greater China, topline data readout for KarXT from its Phase 3 EMERGENT-2 trial in the third quarter of 2022, and continued investment in R&D to advance our proprietary pipeline with global rights, including moving ZL-1102 into full global development.
“Importantly, our commercial team continues to drive significant growth with our four marketed products in Greater China. We remain very confident in the underlying strengths of our business despite the challenges due to the COVID situation in certain regions in China, current macro and geopolitical headwinds. The fundamental drivers of value at Zai Lab are further strengthened by our expanding leadership team and global talent, the steps we have taken to facilitate access to global capital markets, and our track record of consistent execution in bringing global first and best-in-class medicines to patients in China and beyond. Looking forward, we at Zai Lab remain committed in pursuit of our overall vision of improving human health worldwide, and to build a leading global biopharmaceutical company.”
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 China as a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.
Recent Product Highlight
Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that disrupt cancer cell division. Optune and Optune Lua, commercial TTFields devices, are approved or marketed in certain countries or regions for the treatment of newly diagnosed and recurrent glioblastoma and malignant pleural mesothelioma.
Recent Product Highlights
Anticipated 2022 Partner and Zai Milestones
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 and China for advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.
Recent Product Highlight
Adagrasib
Adagrasib is a highly selective and potent oral small-molecule inhibitor of KRASG12C for treating KRASG12C-mutated NSCLC, colorectal cancer (CRC), pancreatic cancer and other solid tumors. 
Anticipated 2022 Zai Milestone
Anticipated 2022 Partner Milestones
Bemarituzumab
Bemarituzumab is a potential first-in-class antibody that is being developed in gastric and gastroesophageal junction (GEJ) cancer as a targeted therapy for tumors that overexpress FGFR2b.
Recent Product Highlights
Anticipated 2022 Zai Milestone
Anticipated 2022 Partner Milestone
Odronextamab
Odronextamab is a bispecific antibody designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).
Recent Product Highlight
Anticipated 2022 Partner and Zai Milestone
Anticipated 2022 Partner Milestones
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.
Recent Product Highlights
Anticipated 2022 Zai Milestones
Anticipated 2022 Partner Milestones
CLN-081
CLN-081 is an orally available, irreversible epidermal growth factor receptor (EGFR) inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR.
Recent Product Highlight
Anticipated 2022 Zai Milestone
Anticipated 2022 Partner Milestones
Elzovantinib (TPX-0022)
Elzovantinib 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 2022 Zai Milestone
Anticipated 2022 Partner Milestones
Retifanlimab
Retifanlimab is an investigational monoclonal antibody that inhibits PD-1.
Recent Product Update
Anticipated 2022 Partner and Zai Milestone
BLU-945
BLU-945 is a selective and potent investigational inhibitor of EGFR harboring either the activating L858R or exon 19 deletion mutations combined with the acquired T790M and C797S mutations, common on-target resistance mutations to first-generation EGFR inhibitors and osimertinib, respectively, for potential treatment of EGFR-driven NSCLC.
Recent Product Highlights
Anticipated 2022 Partner Milestones
BLU-701
BLU-701 is a selective and potent investigational inhibitor of EGFR harboring either the activating L858R or exon 19 deletion mutations combined with the acquired C797S mutation, a common on-target resistance mutation to osimertinib, for potential treatment of EGFR-driven NSCLC.
Recent Product Highlight
Anticipated 2022 Partner Milestone
Internal R&D Oncology Programs
Recent Highlights
Simurosertib, ZL-2309 (CDC7 Inhibitor, Global Rights)
Simurosertib, or ZL-2309, is a potential first-in-class oral selective inhibitor of CDC7, a protein kinase with key roles in DNA replication and in bypassing DNA damage response.
Anticipated 2022 Zai Milestone
ZL-1201 (CD47 Inhibitor, Global Rights)
ZL-1201 is a humanized, IgG4 monoclonal antibody, engineered to reduce effector function, that specifically targets CD47. Its therapeutic potential will be assessed in both solid tumors and hematological malignancies and in both monotherapy and combination opportunities.
Anticipated 2022 Zai Milestone
Autoimmune Diseases
VYVGART® (Efgartigimod)
Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) autoantibodies and block the IgG recycling process. It binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG from degradation.
Recent Product Highlights
Anticipated 2022 Zai Milestones
Anticipated 2022 Partner Milestones
ZL-1102 (IL-17 Human VH Antibody Fragment, Global Rights)
ZL-1102 is a novel human VH antibody fragment (Humabody®) targeting the IL-17A cytokine with high affinity and avidity. Unlike other anti-IL-17 products, ZL-1102 is being developed as a topical treatment for mild-to-moderate chronic plaque psoriasis (CPP).
Anticipated 2022 Zai Milestone
Infectious Disease
NUZYRA (Omadacycline)
NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Zai Lab led the China development and obtained approval by the NMPA in December 2021.
Anticipated 2022 Zai Milestones
Sulbactam-Durlobactam (SUL-DUR, Asia Pacific Rights)
Sulbactam-Durlobactam is a beta-lactam/beta-lactamase inhibitor combination that provides unique activity against Acinetobacter organisms, including carbapenem-resistant strains.
Recent Product Highlight
Anticipated 2022 Zai Milestone
Anticipated 2022 Partner Milestone
Neuroscience
KarXT
KarXT combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist. In November 2021, Zai partnered with Karuna to develop KarXT in Greater China for the treatment schizophrenia and possibly other indications like dementia-related psychosis.
Anticipated 2022 Zai Milestones
Anticipated 2022 Partner Milestones
Corporate Updates
First-Quarter 2022 Financial Results
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast tomorrow, May 11, 2022, at 8:00 a.m. ET. Listeners may access the live webcast by visiting the Company’s website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows:
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 http://ir.zailaboratory.com.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is a patient-focused, innovative, commercial-stage, global biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders, infectious diseases, and neuroscience. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies to generate a broad pipeline of innovative marketed products and product candidates. We have also built an in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing, and commercializing our portfolio to impact human health worldwide.
For additional information about Zai Lab, including information on our products, business activities and partnerships, research, or other events or developments that may be of interest to investors, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our strategy and plans; potential of and expectations for our business and pipeline programs; capital allocation and investment strategy; clinical development programs; clinical trial data, data readouts and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety and efficacy of our collaboration partners’ products and of our pipeline therapies; the anticipated benefits and potential of investments, collaborations and business development activities; our future financial and operating results; financial guidance, including our projections for the number of marketed products we will have in the future; our revenue projections for our current lung cancer and GI cancer franchises; our key data readouts and regulatory filings across our entire portfolio; our plans to file the NDA for efgartigimod in China and for our other products and product candidates in China and elsewhere; and our plans to initiate or continue existing clinical trials for our other products and product candidates. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on our business and general economic, regulatory and political conditions, (6) risks related to doing business in China and (7) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
For more information about our SEC filings, please go to www.SEC.gov.
For more information, please contact:
ZAI LAB CONTACTS:

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Investor Relations: Lina Zhang
+86 136 8257 6943
[email protected]

Media: Danielle Halstrom / Xiaoyu Chen
+1 (215) 280-3898 / +86 185 0015 5011
[email protected] / [email protected] 

Zai Lab Limited
Unaudited condensed consolidated balance sheets
(In thousands of U.S. dollars (“$”) except for number of shares and per share data)

Zai Lab Limited
Unaudited condensed consolidated statements of operations
(In thousands of U.S. dollars (“$”) except for number of shares and per share data)
Note: Basic and diluted net loss per ordinary share, weighted average number of ordinary shares for the three months ended March 31, 2021 have been retrospectively adjusted as a result of the Share Subdivision and the ADS Ratio Change that became effective on March 30, 2022. The Share Subdivision and ADS Ratio Change did not result in any change to the number of outstanding ADSs of the Company.  


Zai Lab Limited
Unaudited condensed consolidated statements of comprehensive loss
(In thousands of U.S. dollars (“$”) except for number of shares and per share data)
 

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