— Broad Product Pipeline Expands Both Vertically and Horizontally with Three New Potential First-in-Class or Best-in-Class Medicines
— Company to Host Conference Call and Webcast on November 10, 2021, at 8:00 a.m. EST
SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Nov. 09, 2021 (GLOBE NEWSWIRE) — Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced financial results for the third quarter of 2021, along with recent product highlights and corporate updates.
�In the third quarter of 2021, we continued to deliver strong growth and performance, said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. We made important advances across our broad, innovative product portfolio and recently added three new potentially transformative medicines. Our agreement with Blueprint Medicines for two promising lung cancer drug candidates presents opportunities to further deepen our potentially world-class lung cancer franchise. Our partnership with Karuna Therapeutics allows us to expand into neuroscience with an exciting anchor asset. Neuroscience is a disease area with a large patient population and significant unmet medical needs.
Notable updates across our business in the quarter included:
We have had a very productive year and built a stronger pipeline with depth and breadth, Dr. Du concluded. With 28 products in our innovative pipeline, we expect our fourth quarter and 2022 to be rich in milestones to unlock significant value in our business.
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.
Recent Product Highlight
Anticipated 2021 Zai Milestones
Tumor Treating Fields
Tumor Treating Fields (TTFields) 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
Anticipated 2021 / Early 2022 Zai Milestone
Anticipated 2021 Partner Milestone
QINLOCK® (ripretinib)
QINLOCK is a switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and PDGFR?-mutated kinases. It is the only therapeutic approved in the United States and China for advanced gastrointestinal stromal tumors (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.
Recent Product Highlights
Anticipated 2021 Partner Milestones
Adagrasib
Adagrasib is a highly selective and potent oral small-molecule inhibitor of KRAS G12C for treating KRAS-G12C-mutated NSCLC, colorectal cancer (CRC), pancreatic cancer and other solid tumors.
Recent Product Highlights
Anticipated 2021 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 2021 / 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 2021 / 2022 Partner Milestone
MARGENZA® (Margetuximab)
MARGENZA is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2).
Recent Product Highlight
Anticipated 2021 / Early 2022 Zai Milestone
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 Highlights
Anticipated Early 2022 Partner Milestone
Elzovantinib (TPX-0022)
Elzovantinib (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.
Recent Product Highlight
Anticipated 2021 / 2022 Partner Milestones
Tebotelimab
Tebotelimab is an investigational, first-in-class, bispecific, tetravalent DART molecule targeting PD-1 and LAG-3.
Recent Product Highlight
Anticipated First Half 2022 Zai and Partner Milestone
BLU-945
BLU-945 is a selective and potent inhibitor of EGFR activating mutations combined with the acquired T790M and C797S mutations, common on-target resistance mechanisms, for the potential treatment of EGFR-positive NSCLC.
Recent Product Highlight
Anticipated Early 2022 Partner Milestone
BLU-701
BLU-701 is a selective and potent inhibitor of EGFR activating mutations combined with the acquired C797S mutation, a common on-target resistance mechanism, for the potential treatment of EGFR-positive NSCLC.
Anticipated 2021 Partner 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 2021 / Early 2022 Zai Milestone
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 2021 / Early 2022 Zai Milestone
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.
Anticipated 2021 Zai Milestones
Anticipated 2021 / Early 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).
Recent Product Highlight
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).
Anticipated 2021 Zai Milestone
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.
Recent Product Highlight
Neuroscience
KarXT
KarXT combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist, to preferentially stimulate muscarinic receptors in the central nervous system for potential treatment of schizophrenia and dementia-related psychosis.
Recent Product Highlights
Anticipated 2021 Partner Milestones
Corporate Updates
Third-Quarter 2021 Financial Results
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast on November 10, 2021, at 8:00 a.m. ET. Listeners may access the live webcast by visiting the Companys website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows:
Registration Link: http://apac.directeventreg.com/registration/event/9666772
Conference ID: 9666772
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 Companys 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 and infectious disease. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order 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 in order to impact human health worldwide.
For additional information about the company, 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, date 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 investigational therapies; the anticipated benefits and potential of investments, collaborations and business development activities; our future financial and operating results; and 2021 financial guidance. These forward-looking statements include, without limitation, statements containing 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 statements of historical fact nor are they 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. Actual results may differ materially from those indicated by such 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 finance our operations and business initiatives and obtain funding for such activities, (3) our results of 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 and (6) the risk factors identified in our most recent annual or quarterly report 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, please contact:
ZAI LAB CONTACTS:
Investor Relations: Ron Aldridge / Lina Zhang
+1 (781) 434-8465 / +86 136 8257 6943
ronald.aldridge@zailaboratory.com / lina.zhang@zailaboratory.com
Media: Danielle Halstrom / Xiaoyu Chen
+1 (215) 280-3898 / +86 185 0015 5011
danielle.halstrom@zailaboratory.com / xiaoyu.chen@zailaboratory.com
Zai Lab Limited
Unaudited Condensed Consolidated balance sheets
(In thousands of U.S. dollars (“$”) except for number of shares and per share data)
As of | |||||
September 30, 2021 | December 31, 2020 | ||||
$ | $ | ||||
Assets | |||||
Current assets: | |||||
Cash and cash equivalents | 1,398,498 | 442,116 | |||
Short-term investments | 170,000 | 744,676 | |||
Accounts receivable (net of allowance for credit loss of $6 and $1 as of September 30, 2021 and December 31, 2020, respectively) | 21,018 | 5,165 | |||
Inventories | 12,494 | 13,144 | |||
Prepayments and other current assets | 17,077 | 10,935 | |||
Total current assets | 1,619,087 | 1,216,036 | |||
Restricted cash, non-current | 743 | 743 | |||
Long term investments (including the fair value measured investments of $20,070 and nil as of September 30, 2021 and December 31, 2020, respectively) | 20,801 | 1,279 | |||
Prepayments for equipment | 1,129 | 274 | |||
Property and equipment, net | 37,087 | 29,162 | |||
Operating lease right-of-use assets | 15,514 | 17,701 | |||
Land use rights, net | 7,749 | 7,908 | |||
Intangible assets, net | 1,678 | 1,532 | |||
Long-term deposits | 901 | 862 | |||
Value added tax recoverable | 23,390 | 22,141 | |||
Total assets | 1,728,079 | 1,297,638 | |||
Liabilities and shareholders’ equity | |||||
Current liabilities: | |||||
Accounts payable | 51,406 | 62,641 | |||
Current operating lease liabilities | 6,312 | 5,206 | |||
Other current liabilities | 54,292 | 30,196 | |||
Total current liabilities | 112,010 | 98,043 | |||
Deferred income | 17,487 | 16,858 | |||
Non-current operating lease liabilities | 10,652 | 13,392 | |||
Total liabilities | 140,149 | 128,293 | |||
Shareholders’ equity | |||||
Ordinary shares (par value of $0.00006 per share; 500,000,000 shares authorized, 95,273,589 and 87,811,026 shares issued and outstanding as of September 30,2021 and December 31, 2020, respectively) | 6 | 5 | |||
Additional paid-in capital | 2,812,830 | 1,897,467 | |||
Accumulated deficit | (1,206,249 | ) | (713,603 | ) | |
Accumulated other comprehensive loss | (15,124 | ) | (14,524 | ) | |
Treasury Stock (at cost, 27,722 and nil shares as of September 30, 2021 and December 31, 2020, respectively) | (3,533 | ) | | ||
Total shareholders’ equity | 1,587,930 | 1,169,345 | |||
Total liabilities and shareholders’ equity | 1,728,079 | 1,297,638 | |||
Zai Lab Limited
Unaudited Condensed Consolidated statements of operations
(In thousands of U.S. dollars (“$”) except for number of shares and per share data)
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||
$ | $ | $ | $ | ||||||||
Revenue | 43,103 | 14,651 | 100,141 | 33,864 | |||||||
Expenses: | |||||||||||
Cost of sales | ?12,162 | ) | (4,934 | ) | (30,535 | ) | (9,914 | ) | |||
Research and development | (55,144 | ) | (58,100 | ) | (401,220 | ) | (160,149 | ) | |||
Selling, general and administrative | (59,002 | ) | (27,874 | ) | (149,254 | ) | (70,346 | ) | |||
Loss from operations | (83,205 | ) | (76,257 | ) | (480,868 | ) | (206,545 | ) | |||
Interest income | 713 | 866 | 1,171 | 3,748 | |||||||
Interest expenses | | (43 | ) | | (157 | ) | |||||
Other (expenses) income, net | (13,580 | ) | 11,958 | (12,401 | ) | 11,267 | |||||
Loss before income tax and share of loss from equity method investment | (96,072 | ) | (63,476 | ) | (492,098 | ) | (191,687 | ) | |||
Income tax expense | | | | | |||||||
Share of loss from equity method investment | (340 | ) | (265 | ) | (548 | ) | (671 | ) | |||
Net loss | (96,412 | ) | (63,741 | ) | (492,646 | ) | (192,358 | ) | |||
Net loss attributable to ordinary shareholders | (96,412 | ) | (63,741 | ) | (492,646 | ) | (192,358 | ) | |||
Loss per share – basic and diluted | (1.01 | ) | (0.84 | ) | (5.34 | ) | (2.59 | ) | |||
Weighted-average shares used in calculating net loss per ordinary share – basic and diluted | 95,035,432 | 75,436,646 | 92,174,838 | 74,381,115 | |||||||
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)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||
2021 | 2020 | 2021 | 2020 | |||||
$ | $ | $ | $ | |||||
Net loss | (96,412 | ) | (63,741 | ) | (492,646 | ) | (192,358 | ) |
Other comprehensive income (loss), net of tax of nil: | ||||||||
Foreign currency translation adjustments | 1,741 | (9,901 | ) | (600 | ) | (7,535 | ) | |
Comprehensive loss | (94,671 | ) | (73,642 | ) | (493,246 | ) | (199,893 | ) |
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