MacroGenics Provides Update on Corporate Progress and 2023 Financial Results
MacroGenics, Inc. (NASDAQ: MGNX) provides updates on recent corporate progress, including the presentation of preliminary data from the TAMARACK Phase 2 study of vobra duo in mCRPC patients at ASCO 2024. The company also initiates a Phase 1 study of MGC026, its first topoisomerase I inhibitor-based ADC. Preclinical data on two ADC product candidates, MGC026 and MGC028, will be presented at AACR. A conference call is scheduled to discuss these developments.
The initiation of the Phase 1 study of MGC026 and the presentation of preclinical data on MGC026 and MGC028 are significant milestones for MacroGenics. These topoisomerase I inhibitor-based Antibody-Drug Conjugates (ADCs) represent a novel class of therapeutics that combine the specificity of monoclonal antibodies with the potency of cytotoxic drugs. ADCs have shown promise in targeting cancer cells while sparing healthy ones, potentially offering a more favorable safety profile compared to traditional chemotherapy.
As an oncologist, the progression of these compounds through the developmental pipeline is promising, especially for metastatic Castration-Resistant Prostate Cancer (mCRPC) patients. mCRPC is a challenging condition to treat due to its resistance to hormonal therapies. The TAMARACK Phase 2 study's preliminary data presentation at ASCO 2024 will be closely watched for its efficacy and safety outcomes, which could influence future treatment paradigms for mCRPC.
From a financial perspective, MacroGenics' update is a harbinger of potential future value creation. The successful completion of enrollment for the TAMARACK Phase 2 study ahead of schedule is a positive operational indicator. Efficiency in clinical trial management can lead to cost savings and faster time-to-market, subject to regulatory approvals. Investors should monitor the upcoming data presentations as they could impact the company's stock performance, especially if the results are favorable and demonstrate a competitive edge in the oncology market.
Furthermore, the initiation of new trials and the continued progress of the company's pipeline are critical for sustained investor interest. The development of lorigerlimab and the combination study with vobra duo could diversify MacroGenics' portfolio and mitigate risks associated with clinical trial failures. The financial results for the year ended December 31, 2023, will also be scrutinized for indications of the company’s burn rate and runway, which are pivotal for assessing its financial health and future funding needs.
Looking at the broader oncology market, MacroGenics' focus on ADCs positions it within a growing segment that is gaining traction due to its potential to deliver targeted therapies for cancer. The global ADC market is expected to grow significantly, driven by a robust pipeline and increasing incidence of cancer. The presentation of preclinical and clinical data at prestigious conferences such as ASCO and AACR enhances the company's visibility within the scientific community and can foster collaborations or attract potential partnership opportunities.
It's also important to consider the competitive landscape. The outcome of the TAMARACK and LORIKEET studies will determine how MacroGenics' candidates stack up against existing treatments and other ADCs in development. Positive data could position the company as a strong player in the mCRPC treatment space, while any setbacks could be detrimental given the high stakes and investment in these trials.
03/07/2024 - 04:01 PM
Presentation of preliminary data from TAMARACK Phase 2 study of vobra duo in mCRPC patients expected at ASCO 2024 Initiation of Phase 1 study of MGC026, MacroGenics' first topoisomerase I inhibitor-based ADC Preclinical data on two topoisomerase I inhibitor-based ADC product candidates, MGC026 and MGC028, to be presented in posters at AACR Conference call scheduled for today at 4:30 p.m. ET ROCKVILLE, Md., March 07, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing 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 year ended December 31, 2023.
“We expect that 2024 will be an important year for MacroGenics, with multiple pipeline advancements anticipated," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Late last year, we completed enrollment of 177 patients in the TAMARACK Phase 2 study of vobra duo, which was ahead of schedule. We plan to present the initial TAMARACK clinical data in the second quarter of this year. Later in the year, we expect to share updated clinical data from the trial. In addition, we continue to enroll the LORIKEET Phase 2 study of lorigerlimab in mCRPC and expect to start enrolling patients in the dose expansion portion of the combination study of vobra duo and lorigerlimab. Finally, we are excited about the potential of our topoisomerase I inhibitor-based ADCs, including MGC026, for which we recently began a Phase 1 study, and MGC028, for which we anticipate submitting an IND by year end.”
Updates on Proprietary Investigational Programs
Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below.
Vobramitamab duocarmazine (vobra duo MacroGenics completed enrollment of the TAMARACK Phase 2 study of vobra duo in November 2023. A total of 177 patients have been dosed in the study, exceeding the study design goal of 100 participants. TAMARACK is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with one prior androgen receptor axis-targeted therapy (ARAT). Participants may have received up to one prior taxane-containing regimen, but no other chemotherapy agents. The TAMARACK study is designed to evaluate vobra duo at two different doses: 2.0 mg/kg or 2.7 mg/kg every four weeks (q4W). MacroGenics intends to expand the TAMARACK study of vobra duo by enrolling patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), melanoma, squamous cell carcinoma of the head and neck (SCCHN) and anal cancer. The Company expects to initiate dosing in these additional cohorts in mid-2024. MacroGenics continues to enroll a Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with various advanced solid tumors. The Company anticipates commencing a dose expansion study of this combination in mCRPC and at least one additional indication in 2024. Lorigerlimab ® molecule. MacroGenics is enrolling LORIKEET, a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve mCRPC patients. A total of 150 patients are planned to be treated in the 2:1 randomized study. The current trial design includes a primary study endpoint of radiographic progression-free survival (rPFS). The Company anticipates providing a study update in the second half of 2024.MGD024 MGC026 MGC028 Enoblituzumab 2023 Financial Results
Cash Position : Cash, cash equivalents and marketable securities balance as of December 31, 2023, was $229.8 million , compared to $154.3 million as of December 31, 2022.Revenue : Total revenue was $58.7 million for the year ended December 31, 2023, compared to total revenue of $151.9 million for the year ended December 31, 2022. The decrease was primarily due to a decrease in revenue from collaborative and other agreements.R&D Expenses : Research and development expenses were $166.6 million for the year ended December 31, 2023, compared to $207.0 million for the year ended December 31, 2022. The decrease was primarily due to decreased manufacturing-related costs for vobra duo, decreased development and clinical trial costs related to margetuximab, and decreased costs related to discontinued studies, partially offset by increased expenses related to MGC026 and MGC028 development.SG&A Expenses : Selling, general and administrative expenses were $52.2 million for the year ended December 31, 2023, compared to $58.9 million for the year ended December 31, 2022. The decrease was primarily related to decreased selling costs for MARGENZA® .Other Income : During the year ended December 31, 2023, MacroGenics received $100.0 million proceeds from the sale of its single-digit royalty interest on global net sales of TZIELD® to DRI Healthcare Acquisitions LP. In addition, the Company received a $50.0 million milestone payment from Sanofi S.A. related to the achievement of a primary endpoint in a TZIELD clinical study. Under GAAP guidelines and pursuant to Financial Accounting Standards Board’s Accounting Standards Codification 470, this combined $150.0 million was included in Other Income as a “Gain on royalty monetization arrangement” in 2023.Net Loss : Net loss was $9.1 million for the year ended December 31, 2023, compared to net loss of $119.8 million for the year ended December 31, 2022.Shares Outstanding : Shares of common stock outstanding as of December 31, 2023 were 62,070,627.Cash Runway Guidance : MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $229.8 million as of December 31, 2023, in addition to projected and anticipated future payments from partners and product revenues should extend its cash runway into 2026. The Company’s expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial, the Phase 2 LORIKEET study as well as MacroGenics’ other ongoing clinical and preclinical studies.Conference Call Information
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The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ 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 MacroGenics’ website for 30 days following the call.
MACROGENICS, INC. SELECTED CONSOLIDATED BALANCE SHEET DATA (Amounts in thousands) December 31, 2023 December 31, 2022 Cash, cash equivalents and marketable securities $ 229,805 $ 154,346 Total assets 298,418 280,468 Deferred revenue 80,893 69,468 Total stockholders' equity 152,613 142,013
MACROGENICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Amounts in thousands, except share and per share data) 2023 2022 2021 Revenues: Collaborative and other agreements $ 28,990 $ 119,303 $ 63,294 Product sales, net 17,939 16,727 12,349 Contract manufacturing 9,833 13,988 — Royalty revenue 431 — — Government agreements 1,556 1,923 1,804 Total revenues 58,749 151,941 77,447 Costs and expenses: Cost of product sales 619 3,351 2,651 Cost of manufacturing services 7,603 4,033 — Research and development 166,583 207,026 214,577 Selling, general and administrative 52,188 58,949 63,014 Total costs and expenses 226,993 273,359 280,242 Loss from operations (168,244 ) (121,418 ) (202,795 ) Gain on royalty monetization arrangement 150,930 — — Interest and other income 9,686 1,660 680 Interest expense (1,430 ) — — Net loss (9,058 ) (119,758 ) (202,115 ) Other comprehensive income (loss): Unrealized gain (loss) on investments (1 ) 56 (54 ) Comprehensive income (loss) $ (9,059 ) $ (119,702 ) $ (202,169 ) Basic and diluted net loss per common share $ (0.15 ) $ (1.95 ) $ (3.37 ) Basic and diluted weighted average common shares outstanding 61,929,198 61,433,124 59,944,717
About MacroGenics, Inc.
MacroGenics (the Company) is a biopharmaceutical company focused on discovering, developing, manufacturing 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, manufacturing services revenue, 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, as well as future global net sales of TZIELD and the Company’s ability to achieve the milestone payments set forth under the terms of the agreement with DRI (or its successors or assigns with respect to such agreement), 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 TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal 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; expectations of future milestone payments; 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, 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.
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What is the ticker symbol for MacroGenics, Inc.?
The ticker symbol for MacroGenics, Inc. is MGNX.
What study is MacroGenics presenting data from at ASCO 2024?
MacroGenics is presenting preliminary data from the TAMARACK Phase 2 study of vobra duo in mCRPC patients at ASCO 2024.
What is the focus of MacroGenics' Phase 1 study of MGC026?
MacroGenics' Phase 1 study of MGC026 is focused on its first topoisomerase I inhibitor-based ADC.
Where will preclinical data on two ADC product candidates be presented?
Preclinical data on two ADC product candidates, MGC026 and MGC028, will be presented in posters at AACR.
When is the conference call scheduled for?
The conference call is scheduled for today at 4:30 p.m. ET.
