05/03/2022 | Press release | Distributed by Public on 05/03/2022 14:07
MacroGenics Provides Update on Corporate Progress and First Quarter 2022 Financial Results
ROCKVILLE, Md., May 03, 2022 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative 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 March 31, 2022.
"We are very pleased by the progress made during the first quarter. Our recent end of Phase 1 meeting with the U.S. Food and Drug Administration (FDA) regarding MGC018, our B7-H3-directed antibody-drug conjugate (ADC), marks a significant milestone for the Company. Our current Phase 2/3 clinical plan for MGC018 reflects our productive dialogue with the FDA and feedback received on key elements of the program. We are targeting commencement of enrollment of the Phase 2/3 study by year-end," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Other exciting developments include the initiation of a Phase 1 dose escalation study of MGC018 in combination with lorigerlimab in advanced solid tumors and FDA clearance of the IND for MGD024, our investigational next-generation CD123 × CD3 DART® molecule, enabling MacroGenics to proceed with the planned initiation of a clinical trial in CD123-positive neoplasms, including acute myeloid leukemia (AML) in mid-2022."
Updates on Proprietary Investigational Programs
B7-H3 Programs: MacroGenics is developing two clinical product candidates that target B7-H3, an antigen with broad expression across multiple solid tumor types and a member of the B7 family of molecules involved in immune regulation. Recent highlights for these two molecules include:
The Company expects analysis of the data to be performed upon completion of the Phase 2 portion of the study. In the Phase 3 portion, MacroGenics plans to randomize additional patients 1:1 to receive either MGC018 at the recommended dose or an ARAT agent for the control group. The inclusion of the Phase 2 interim analysis to evaluate the two MGC018 dose levels will allow the Company to further assess safety, tolerability and futility before proceeding to the Phase 3 portion of the study. The primary endpoint of the study will be radiographic progression-free survival (rPFS) and key secondary endpoints include objective response rate (ORR) and overall survival (OS). The Company expects to begin enrollment by year-end 2022.
DART Molecules for Immune Checkpoint Blockade: MacroGenics is studying multiple PD-1-directed programs to provide further differentiation from existing PD-1-based treatment options and enable combination opportunities across the Company's portfolio. Recent highlights for one of these molecules include:
Bispecific CD123 × CD3 DART molecule: MacroGenics is developing an investigational, next-generation CD123 × CD3 DART molecule. Recent updates include:
Other Program Updates:
First Quarter 2022 Financial Results
Conference Call Information
MacroGenics will host a conference call today at 4:30 p.m. (ET) to discuss financial results for the quarter ended March 31, 2022, 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: 6791448.
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) |
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March 31, 2022 | December 31, 2021 | ||||||
Cash, cash equivalents and marketable securities | $ | 183,986 | $ | 243,616 | |||
Total assets | 271,445 | 335,245 | |||||
Deferred revenue | 31,926 | 20,646 | |||||
Total stockholders' equity | 178,214 | 239,618 | |||||
MACROGENICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) |
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(Amounts in thousands, except share and per share data) | ||||||||
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
Revenues: | ||||||||
Revenue from collaborative and other agreements | $ | 7,093 | $ | 15,184 | ||||
Product revenue, net | 3,580 | 887 | ||||||
Revenue from government agreements | 428 | 810 | ||||||
Total revenues | 11,101 | 16,881 | ||||||
Costs and expenses: | ||||||||
Cost of product sales | 48 | 17 | ||||||
Research and development | 61,438 | 53,121 | ||||||
Selling, general and administrative | 16,253 | 15,036 | ||||||
Total costs and expenses | 77,739 | 68,174 | ||||||
Loss from operations | (66,638 | ) | (51,293 | ) | ||||
Other income | 195 | 21 | ||||||
Net loss | (66,443 | ) | (51,272 | ) | ||||
Other comprehensive income (loss): | ||||||||
Unrealized gain (loss) on investments | (222 | ) | 18 | |||||
Comprehensive income (loss) | $ | (66,665 | ) | $ | (51,254 | ) | ||
Basic and diluted net loss per common share | $ | (1.08 | ) | $ | (0.90 | ) | ||
Basic and diluted weighted average common shares outstanding | 61,324,163 | 57,202,846 | ||||||
About MacroGenics, Inc.
MacroGenics (the Company) 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 MacroGenics ("Company"), including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, including initiation and enrollment in clinical trials, expected timing of results from clinical trials, discussions with regulatory agencies, commercial prospects of or product revenues from MARGENZA and the Company's product candidates, if approved, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "potential," "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 MGC018, MARGENZA or any other product candidate's revenue, expenses and costs may not be as expected, risks relating to MGC018, MARGENZA or any other product candidate's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, the availability of financing to fund the development of our product candidates, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business, or economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises such as the novel coronavirus (referred to as COVID-19 pandemic), 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 CommunicationsJim Karrels, Senior Vice President, CFO
1-301-251-5172
[email protected]
Source: MacroGenics, Inc.