MGNX MacroGenics Inc.

24.96
-1.12  -4%
Previous Close 26.08
Open 25.26
52 Week Low 18.16
52 Week High 36.4804
Market Cap $1,498,508,719
Shares 60,036,407
Float 58,451,665
Enterprise Value $1,255,496,908
Volume 659,356
Av. Daily Volume 797,303
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
MARGENZA (margetuximab) and MGA012 (MAHOGANY)
Gastric cancer
Phase 2/3
Phase 2/3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
MGC018
Solid tumors
Phase 1
Phase 1
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
MARGENZA (margetuximab)
Metastatic breast cancer
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Tebotelimab (MGD013)
Solid tumors
Phase 1
Phase 1
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Flotetuzumab
AML
Phase 1/2
Phase 1/2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
IMGC936
Solid Tumors
Phase 1
Phase 1
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
MGD024
cytokine-release syndrome
Phase 1
Phase 1
IND to be submitted 4Q 2021.
MGD019
Solid tumors
Phase 1
Phase 1
Phase 1 data presented at ESMO September 2020. ORR 4/18. Phase 1 dose expansion trial ongoing.
Enoblituzumab and retifanlimab
Squamous cell carcinoma of the head and neck (SCCHN)
Phase 2
Phase 2
Phase 2 trial has been initiated.
Retifanlimab
Anal cancer
Phase 2
Phase 2
Phase 2 data noted objective response rate of 14% and disease control rate of 49% - September 18, 2020.
Retifanlimab - (POD1UM-304)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial initiation announced September 21, 2020.

Latest News

    • Upcoming MGC018 and margetuximab MAHOGANY clinical data presentations at European Society for Medical Oncology (ESMO) Meeting
    • Conference call scheduled for today at 4:30 p.m. ET.

    ROCKVILLE, Md., July 29, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2021.

    "In June, we presented encouraging data from a Phase 1 study of MGC018 at ASCO. We look forward to providing further updates on this compound and margetuximab in gastric cancer at ESMO in September. Beyond these…

    • Upcoming MGC018 and margetuximab MAHOGANY clinical data presentations at European Society for Medical Oncology (ESMO) Meeting
    • Conference call scheduled for today at 4:30 p.m. ET.

    ROCKVILLE, Md., July 29, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2021.

    "In June, we presented encouraging data from a Phase 1 study of MGC018 at ASCO. We look forward to providing further updates on this compound and margetuximab in gastric cancer at ESMO in September. Beyond these two programs, we continue to progress our growing pipeline of investigational therapeutics for the potential treatment of cancer as well as to execute on the recent launch and commercialization of MARGENZA® with our partner, EVERSANA," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Also in June, we announced our broad strategic collaboration with Zai Lab to develop and commercialize preclinical bispecific antibodies in oncology. We're very pleased to have entered this second collaboration with Zai Lab."

    Key Updates on Proprietary Programs

    Recent progress and anticipated events in 2021 related to MacroGenics' approved product, MARGENZA, and its investigational product candidates in clinical development are highlighted below.

    • Margetuximab is an Fc-engineered, monoclonal antibody (mAb) that targets the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal and other solid tumor cells.
      • MARGENZA (margetuximab-cmkb) commercial launch. In March 2021, MacroGenics and its commercial partner, EVERSANA, launched MARGENZA for the treatment of adult patients with metastatic HER2-positive breast cancer, in combination with chemotherapy, who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Based on the accrued overall survival (OS) events in the SOPHIA metastatic breast cancer Phase 3 study, the Company expects to complete and share top-line results from the final analysis of OS data, based on 385 OS events by the end of the third quarter of 2021.
      • Phase 2/3 MAHOGANY study in advanced gastric and gastroesophageal junction cancer.  All 40 patients have been enrolled in the first part of Module A of the MAHOGANY study, which is evaluating margetuximab in combination with retifanlimab, an anti-PD-1 molecule the Company licensed to Incyte Corporation in 2017. The Company plans to report interim safety and efficacy data on these patients at ESMO in September 2021.
    • Flotetuzumab is a bispecific CD123 × CD3 DART® molecule being evaluated in patients with primary induction failure (PIF) and early relapsed (less than six months, or ER6) acute myeloid leukemia (AML). MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER6 AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the composite primary endpoint. The Company anticipates providing further updates on the clinical development of flotetuzumab in late 2021.
    • MGC018 is an antibody-drug conjugate (ADC) that targets B7-H3. In June 2021, MacroGenics presented updated clinical data at the American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating anti-tumor activity in patients with melanoma and metastatic castration-resistant prostate cancer (mCRPC). Preliminary results in the mCRPC cohort expansion showed 11 of 22 patients (50%) had a PSA reduction of 50% or greater, with anti-tumor activity observed in four of seven patients with measurable disease who had their first 9-week imaging results available, including one unconfirmed partial response. Anti-tumor activity was also reported in all three melanoma patients who received 4 mg/kg in dose escalation, with one patient achieving a confirmed partial response. MGC018 trial cohorts are ongoing for mCRPC, melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN) and triple negative breast cancer (TNBC). MacroGenics will provide an update of clinical data at ESMO in September.
    • Enoblituzumab is an Fc‐engineered, anti‐B7‐H3 mAb. MacroGenics continues to recruit its Phase 2 study of enoblituzumab in a chemotherapy-free regimen in combination with retifanlimab in front-line patients with SCCHN who are PD-L1 positive and with tebotelimab in SCCHN patients who are PD-L1 negative. The Company has recently activated clinical trial sites in Europe to advance enrollment of the study.
    • Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. MacroGenics is evaluating the molecule in patients as both monotherapy as well as in combination with other agents. The Company's partner in Greater China, Zai Lab, is evaluating tebotelimab as monotherapy in patients with hepatocellular carcinoma and melanoma as well as in combination with niraparib in a variety of advanced or metastatic solid tumors. MacroGenics expects to provide an update on the next stage of development for tebotelimab later this year.
    • MGD019 is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. The Company is conducting a Phase 1 dose expansion study in cohorts of patients with microsatellite stable colorectal cancer (MSS CRC), checkpoint-naïve NSCLC, mCRPC and melanoma.
    • IMGC936 is an ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types, and is being developed jointly under a 50/50 collaboration with ImmunoGen, Inc. Under the collaboration, ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in patients with select cancers and have indicated they anticipate disclosing initial data in early 2022.
    • MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule in preclinical development. The molecule incorporates a CD3 component designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, along with an Fc domain to permit intermittent dosing through a longer half-life. The Company expects to submit an Investigational New Drug (IND) application to the FDA in the fourth quarter of 2021.

    Second Quarter 2021 Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2021 were $297.3 million, compared to $272.5 million as of December 31, 2020. This does not include $55 million in consideration (consisting of a $25 million upfront payment and a $30 million equity investment) received from Zai Lab in July 2021, which related to the execution of the collaboration agreement that was announced on June 16, 2021.

       
    • Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $30.8 million for the quarter ended June 30, 2021, including $3.2 million net sales of MARGENZA, compared to total revenue of $20.3 million for the quarter ended June 30, 2020. This increase was primarily due to the recognition of $14.4 million of revenue from Zai Lab related to the recent June 2021 collaboration announcement and recognition of a $5 million milestone from Incyte Corporation.



    • R&D Expenses: Research and development expenses were $55.8 million for the quarter ended June 30, 2021, compared to $57.4 million for the quarter ended June 30, 2020.



    • SG&A Expenses: Selling, general and administrative expenses were $15.2 million for the quarter ended June 30, 2021, compared to $10.2 million for the quarter ended June 30, 2020. This increase was primarily related to MARGENZA launch costs.
    • Net Loss: Net loss was $39.9 million for the quarter ended June 30, 2021, compared to net loss of $46.9 million for the quarter ended June 30, 2020.

       
    • Shares Outstanding: Shares outstanding as of June 30, 2021 were 60,133,447, which excluded 958,467 shares issued to Zai Lab in July as part of the recently announced collaboration.

       
    • Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of June 30, 2021, plus consideration received from Zai Lab in July 2021, as well as anticipated and potential collaboration payments, should enable it to fund its operations through 2023, assuming the Company's programs and collaborations advance as currently contemplated.

    Conference Call Information

    MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended June 30, 2021 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 7983402.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    MACROGENICS, INC.

    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (Amounts in thousands)

     June 30, 2021 December 31, 2020
     (unaudited)  
    Cash, cash equivalents and marketable securities$297,316  $272,531 
    Total assets425,911  378,743 
    Deferred revenue30,041  11,382 
    Total stockholders' equity319,045  295,884 

    MACROGENICS, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Amounts in thousands, except share and per share data)

     Three Months Ended June 30, Six Months Ended June 30,
     2021 2020 2021 2020
    Revenues:       
    Revenue from collaborative and other agreements$27,168   $15,636   $42,352   $28,603  
    Product revenue, net3,203      4,090     
    Revenue from government agreements386   4,621   1,196   5,336  
    Total revenues30,757   20,257   47,638   33,939  
    Costs and expenses:       
    Cost of product sales22      39     
    Research and development55,780   57,351   108,901   106,245  
    Selling, general and administrative15,234   10,216   30,270   20,449  
    Total costs and expenses71,036   67,567   139,210   126,694  
    Loss from operations(40,279)  (47,310)  (91,572)  (92,755) 
    Other income344   425   365   1,146  
    Net loss(39,935)  (46,885)  (91,207)  (91,609) 
    Other comprehensive income:       
    Unrealized gain on investments(10)  (55)  8   1  
    Comprehensive loss$(39,945)  $(46,940)  $(91,199)  $(91,608) 
            
    Basic and diluted net loss per common share$(0.66)  $(0.94)  $(1.56)  $(1.85) 
    Basic and diluted weighted average common shares outstanding60,068,315   50,018,462   58,643,496   49,515,562  

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, MARGENZA and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    CONTACTS:

    Chris James, M.D., Vice President, Investor Relations & Corporate Communications

    Jim Karrels, Senior Vice President, CFO

    1-301-251-5172



    Primary Logo

    View Full Article Hide Full Article
  1. ROCKVILLE, MD, July 22, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the second quarter 2021 after the market closes on Thursday, July 29, 2021. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, July 29, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID# 7983402.

    The listen-only webcast of the…

    ROCKVILLE, MD, July 22, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the second quarter 2021 after the market closes on Thursday, July 29, 2021. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, July 29, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID# 7983402.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc. 



    CONTACTS: 
    Christopher James, M.D., Vice President, Investor Relations and Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, 
    

    Primary Logo

    View Full Article Hide Full Article
    • Zai Lab granted combination of regional Asian and global rights for up to four CD3- or CD47-based bispecific molecules
    • MacroGenics provides rights to Zai Lab for its DART® and TRIDENT® multi-specific platforms and a lead research program targeting solid tumors
    • Zai Lab provides rights to MacroGenics for certain intellectual property related to CD47 for select tumor targets

    ROCKVILLE, MD, SHANGHAI and SAN FRANCISCO, June 16, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal-antibody-based therapeutics for the treatment of cancer, and Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), an innovative commercial-stage biopharmaceutical company, announced today…

    • Zai Lab granted combination of regional Asian and global rights for up to four CD3- or CD47-based bispecific molecules
    • MacroGenics provides rights to Zai Lab for its DART® and TRIDENT® multi-specific platforms and a lead research program targeting solid tumors
    • Zai Lab provides rights to MacroGenics for certain intellectual property related to CD47 for select tumor targets

    ROCKVILLE, MD, SHANGHAI and SAN FRANCISCO, June 16, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal-antibody-based therapeutics for the treatment of cancer, and Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), an innovative commercial-stage biopharmaceutical company, announced today that the companies have entered into an exclusive collaboration and license agreement involving up to four immuno-oncology molecules.

    The first collaboration program covers a lead research molecule that incorporates MacroGenics' DART platform and binds CD3 and an undisclosed target that is expressed in multiple solid tumors. The next-generation CD3 component of the DART bispecific molecule has been designed to minimize cytokine-release syndrome while maintaining anti-tumor cytolytic activity. The second collaboration program will cover a target to be designated by MacroGenics. For both molecules, Zai receives commercial rights in Greater China, Japan, and Korea and MacroGenics receives commercial rights in all other territories. For the lead molecule, Zai Lab receives an option upon reaching a predefined clinical milestone to convert the regional arrangement into a global 50/50 profit share.

    Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules. For the four programs, each company will contribute intellectual property to generate either CD3- or CD47-based bispecific antibodies.

    "We are very pleased to be expanding our existing relationship with Zai Lab, which already includes regional rights in Greater China for two clinical-stage programs," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Zai has a strong track record of rapidly progressing the development of innovative product candidates in China. This new partnership enables us to jointly discover, develop and deliver potentially best-in-class therapeutics to address patients' unmet medical needs."

    "MacroGenics has been a great partner and one of the leading companies in the immuno-oncology field," said Samantha Du, Ph.D., Founder, Chairperson, Chief Executive Officer of Zai Lab.  "We are pleased to expand our strategic collaboration, which leverages both companies' unique research capabilities and gives Zai Lab access to MacroGenics' proprietary technologies to expand our innovative oncology portfolio on a global basis."

    Under the terms of the agreement, MacroGenics receives initial consideration from Zai Lab of $55 million, including an upfront payment of $25 million and an equity investment of $30 million in MacroGenics' common stock at $31.30 per share. In addition, MacroGenics is eligible to receive up to $1.4 billion in potential development, regulatory and commercial milestone payments for the four programs. If products from the collaboration are commercialized, MacroGenics would also receive royalties on annual net sales in Zai Lab's territories.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, DART and TRIDENT are trademarks or registered trademarks of MacroGenics, Inc.

    About Zai Lab

    Zai Lab (NASDAQ:ZLAB, HKEX: 9688))) is an innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer and infectious and autoimmune diseases to patients in China and around the world. We aim to address significant unmet medical needs in large, fast-growing segments of the pharmaceutical market. Our experienced team has secured partnerships with leading global biopharmaceutical companies to generate a broad pipeline of potentially innovative, marketed products and product candidates. We have also built an in-house team with strong drug discovery and translational research capabilities and are establishing a pipeline of proprietary drug candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to positively impact human health worldwide.

    For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

    MacroGenics Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Zai Lab Forward-Looking Statements

    This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects and plans for developing and commercializing the preclinical bispecific antibody-based molecules and other 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 Zai Lab's 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) Zai Lab's ability to successfully commercialize and generate revenue from its approved products; (2) Zai Lab's ability to finance its operations and business initiatives and obtain funding for such activities, (3) Zai Lab's results of clinical and pre-clinical development of its product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab's 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. Zai Lab anticipates that subsequent events and developments will cause Zai Lab's expectations and assumptions to change and undertakes 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 Zai Lab's views as of any date subsequent to the date of this press release.

    ###



    For more information, please contact:
    
    MacroGenics Contacts
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172
    
    
    Zai Lab Contacts
    Billy Cho, CFO
    +86 137 6151 2501 
    
    
    Media: Ryo Imai / Robert Flamm, Ph.D.
    Burns McClellan, on behalf of Zai Lab
    212-213-0006 ext. 315 / 364
     / 
    
    Investors: Mike Zanoni
    Endurance Advisors, on behalf of Zai Lab
    610-442-8570
    

    Primary Logo

    View Full Article Hide Full Article
    • Zai Lab granted combination of regional Asian and global rights for up to four CD3- or CD47-based bispecific molecules
    • MacroGenics provides rights to Zai Lab for its DART® and TRIDENT® multi-specific platforms and a lead research program targeting solid tumors
    • Zai Lab provides rights to MacroGenics for certain intellectual property related to CD47 for select tumor targets

    SHANGHAI, SAN FRANCISCO and ROCKVILLE, MD, June 16, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), an innovative commercial-stage biopharmaceutical company, and MacroGenics (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal-antibody-based therapeutics for the treatment of cancer, announced today…

    • Zai Lab granted combination of regional Asian and global rights for up to four CD3- or CD47-based bispecific molecules

    • MacroGenics provides rights to Zai Lab for its DART® and TRIDENT® multi-specific platforms and a lead research program targeting solid tumors
    • Zai Lab provides rights to MacroGenics for certain intellectual property related to CD47 for select tumor targets

    SHANGHAI, SAN FRANCISCO and ROCKVILLE, MD, June 16, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), an innovative commercial-stage biopharmaceutical company, and MacroGenics (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal-antibody-based therapeutics for the treatment of cancer, announced today that the companies have entered into an exclusive collaboration and license agreement involving up to four immuno-oncology molecules.

    The first collaboration program covers a lead research molecule that incorporates MacroGenics' DART platform and binds CD3 and an undisclosed target that is expressed in multiple solid tumors. The next-generation CD3 component of the DART bispecific molecule has been designed to minimize cytokine-release syndrome while maintaining anti-tumor cytolytic activity. The second collaboration program will cover a target to be designated by MacroGenics. For both molecules, Zai receives commercial rights in Greater China, Japan, and Korea and MacroGenics receives commercial rights in all other territories. For the lead molecule, Zai Lab receives an option upon reaching a predefined clinical milestone to convert the regional arrangement into a global 50/50 profit share.

    Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules. For the four programs, each company will contribute intellectual property to generate either CD3- or CD47-based bispecific antibodies.

    "We are very pleased to be expanding our existing relationship with Zai Lab, which already includes regional rights in Greater China for two clinical-stage programs," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Zai has a strong track record of rapidly progressing the development of innovative product candidates in China. This new partnership enables us to jointly discover, develop and deliver potentially best-in-class therapeutics to address patients' unmet medical needs."

    "MacroGenics has been a great partner and one of the leading companies in the immuno-oncology field," said Samantha Du, Ph.D., Founder, Chairperson, Chief Executive Officer of Zai Lab. "We are pleased to expand our strategic collaboration, which leverages both companies' unique research capabilities and gives Zai Lab access to MacroGenics' proprietary technologies to expand our innovative oncology portfolio on a global basis."

    Under the terms of the agreement, MacroGenics receives initial consideration from Zai Lab of $55 million, including an upfront payment of $25 million and an equity investment of $30 million in MacroGenics' common stock at $31.30 per share. In addition, MacroGenics is eligible to receive up to $1.4 billion in potential development, regulatory and commercial milestone payments for the four programs. If products from the collaboration are commercialized, MacroGenics would also receive royalties on annual net sales in Zai Lab's territories.

    About Zai Lab

    Zai Lab (NASDAQ:ZLAB, HKEX: 9688))) is an innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer and infectious and autoimmune diseases to patients in China and around the world. We aim to address significant unmet medical needs in large, fast-growing segments of the pharmaceutical market. Our experienced team has secured partnerships with leading global biopharmaceutical companies to generate a broad pipeline of potentially innovative, marketed products and product candidates. We have also built an in-house team with strong drug discovery and translational research capabilities and are establishing a pipeline of proprietary drug candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to positively impact human health worldwide.

    For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, DART and TRIDENT are trademarks or registered trademarks of MacroGenics, Inc.

    Zai Lab Forward-Looking Statements

    This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects and plans for developing and commercializing the preclinical bispecific antibody-based molecules and other 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 Zai Lab's 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) Zai Lab's ability to successfully commercialize and generate revenue from its approved products; (2) Zai Lab's ability to finance its operations and business initiatives and obtain funding for such activities, (3) Zai Lab's results of clinical and pre-clinical development of its product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab's 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. Zai Lab anticipates that subsequent events and developments will cause Zai Lab's expectations and assumptions to change and undertakes 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 Zai Lab's views as of any date subsequent to the date of this press release.

    MacroGenics Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    For more information, please contact:

    Zai Lab Contacts

    Billy Cho, CFO

    +86 137 6151 2501

    Media: Ryo Imai / Robert Flamm, Ph.D.

    Burns McClellan, on behalf of Zai Lab

    212-213-0006 ext. 315 / 364

    /

    Investors: Mike Zanoni

    Endurance Advisors, on behalf of Zai Lab

    610-442-8570

    MacroGenics Contacts

    Jim Karrels, Senior Vice President, CFO

    1-301-251-5172

    Zai Lab Limited



    Primary Logo

    View Full Article Hide Full Article
    • Dose escalation: anti-tumor activity observed in melanoma (including one confirmed partial response) and in mCRPC patients
    • Cohort expansion in mCRPC: 11/22 (50%) patients have ≥ 50% PSA reduction; anti-tumor activity observed in four of seven patients evaluated (including one unconfirmed partial response)
    • Conference call and webcast with external guest presenters on Friday, June 4, 2021 at 4:30 P.M. ET

    ROCKVILLE, MD, May 19, 2021 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced preliminary safety and anti-tumor activity data from the Company's ongoing Phase 1 clinical…

    • Dose escalation: anti-tumor activity observed in melanoma (including one confirmed partial response) and in mCRPC patients
    • Cohort expansion in mCRPC: 11/22 (50%) patients have ≥ 50% PSA reduction; anti-tumor activity observed in four of seven patients evaluated (including one unconfirmed partial response)
    • Conference call and webcast with external guest presenters on Friday, June 4, 2021 at 4:30 P.M. ET

    ROCKVILLE, MD, May 19, 2021 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced preliminary safety and anti-tumor activity data from the Company's ongoing Phase 1 clinical trial of MGC018. This investigational antibody-drug conjugate (ADC) was designed to deliver a DNA alkylating duocarmycin payload to both dividing and non-dividing cells in a B7-H3-dependent manner. The dataset will be presented in a poster titled "Phase 1 Dose Escalation Study of MGC018, an anti-B7-H3 Antibody-Drug Conjugate (ADC), In Patients with Advanced Solid Tumors" (Abstract #2631) at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 4-8, 2021.

    Dose Escalation Results Update

    The ASCO abstract included data as of January 21, 2021; updated data as of a May 3, 2021 cut-off are included below and will be presented at ASCO.

    A total of 29 patients with advanced solid tumors were enrolled in five dose escalation cohorts with MGC018 at 0.5 to 4.0 mg/kg, administered intravenously every three weeks. This included six patients at the 4.0 mg/kg cohort enrolled subsequent to the 2020 ASCO poster presentation. A recommended Phase 2 dose (RP2D) was defined as 3.0 mg/kg every three weeks.

    mCRPC. Preliminary evidence of anti-tumor activity by MGC018 has been observed, most notably in patients with advanced metastatic castration-resistant prostate cancer (mCRPC). Reductions in prostate-specific antigen (PSA) levels of ≥ 50% were observed in five of nine mCRPC patients treated in dose escalation, including one with substantial regression of bone disease. Of the nine patients with mCRPC, eight were evaluated for tumor response, all of whom demonstrated a best response of stable disease. Two of these eight patients had measurable disease; both had reductions in target lesions, including a 29% reduction in one patient. The nine mCRPC patients treated in dose escalation received a median of four therapies prior to MGC018, including taxane chemotherapy (eight patients) and next generation hormonal agents (all patients had previously received abiraterone, enzalutamide or both). All nine mCRPC patients in dose escalation are off therapy.  Of the five patients who had ≥ 50% PSA reduction, one withdrew consent (without disease progression) at 4 months, one had new bone lesions at 6 months, one initiated subsequent therapy at 6 months, and two had no progression at 7 months.

    Melanoma. During dose escalation, three melanoma patients were administered MGC018 at 4.0 mg/kg (the highest dose administered). All had previously received three different checkpoint inhibitor agents. The best responses in target lesion sum reductions for these patients after being treated with MGC018 were 24%, 28% and 36% (confirmed partial response), with this last patient remaining on MGC018 therapy for more than 6 months as of the data cut-off. Based on these data, MacroGenics recently initiated a melanoma expansion cohort (N=approximately 20).

    Safety. Adverse events for the dose escalation cohorts of 0.5 mg/kg to 4.0 mg/kg as of the May 3, 2021 data cut-off were generally consistent with those previously reported at ASCO 2020. MGC018-related toxicities included hematologic and skin toxicities that have been clinically manageable. In dose escalation overall, at least one treatment-related adverse event was experienced by 27 of 29 patients (93%). At 4.0 mg/kg, one patient developed a dose-limiting toxicity manifested by Grade 3 fatigue that lasted for more than 72 hours and as previously reported, a Grade 4 neutropenia occurred in a patient in the 2.0 mg/kg cohort.

    Preliminary Results for mCRPC Cohort Expansion

    As of the May 3, 2021 data cut-off, 28 of the 40 patients in the mCRPC cohort expansion had been enrolled, with disease classification available for 20 of these patients: seven had bone only, nine had mixed soft tissue and bone, and four had soft tissue only. Of the 28 mCRPC patients in cohort expansion, 22 had received at least one dose of MGC018 and had a post-baseline PSA. Eleven of these 22 patients (50%) had a PSA reduction of 50% or greater. All but three of these 22 patients were still on therapy as of the data cut-off. Of 13 patients who had measurable disease, six were not yet evaluable and seven had their first 9-week imaging, of which four had reductions in target lesion sums of 13%, 21%, 27% and 35% (unconfirmed partial response). Twelve of these 13 patients were still ongoing on MGC018.

    "We continue to be very encouraged by evolving data from our ongoing Phase 1 study of MGC018. To date, we have observed preliminary signals of anti-tumor effects, including PSA reductions of 50% or more in 16 of 31 (52%) patients with late-stage castration-resistant prostate cancer across dose escalation and dose expansion," said Scott Koenig, M.D., Ph.D., President and CEO. "We are very pleased to report decreases in target lesion sums, including an unconfirmed partial response, in mCRPC patients with measurable disease. Finally, we are encouraged to see anti-tumor activity, including a confirmed partial response, in post-checkpoint melanoma patients who have received MGC018. We look forward to sharing the full data at ASCO and providing further updates on our ongoing dose expansion cohorts, including patients with mCRPC, non-small cell lung cancer, triple negative breast cancer, melanoma and squamous cell carcinoma of the head and neck, at subsequent scientific conferences."

    Conference Call

    MacroGenics' management will host a conference call and webcast with external guest presenters to discuss the preliminary MGC018 results on Friday, June 4, 2021 at 4:30 P.M. ET. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 1583522. The listen-only audio and slide webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days.

    ASCO Presentation

    The abstract for MacroGenics' MGC018 poster presentation was submitted to ASCO in February 2021 and is available on the ASCO website at https://conferences.asco.org/am/abstracts. The poster will be available for on-demand viewing on the ASCO website and on the Events & Presentations page on MacroGenics' website at http://ir.macrogenics.com/events.cfm on or around June 4, 2021.

    About MGC018

    MGC018 is an ADC comprised of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. B7-H3 is a molecule highly expressed on many solid tumors and associated with a poor clinical outcome. MGC018 is being evaluated in a Phase 1 study (NCT03729596). MacroGenics retains worldwide rights to MGC018.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    CONTACTS:
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, 

    Primary Logo

    View Full Article Hide Full Article
View All MacroGenics Inc. News