- First patient dosed in Phase 1 study of MGD024 in CD123-positive hematologic malignancies
- Plan to initiate MGC018 Phase 2/3 study in prostate cancer by year-end
- Initiates cost-saving measures through corporate restructuring with focus on key clinical programs, extending cash runway into 2024 with goal of delivering value-creating data milestones
$30 millionmilestone payments received in July from Incyte as part of collaboration agreement
- Conference call scheduled for today at 4:30 p.m. ET.
“We made important progress in the second quarter, during which we completed enrollment in a Phase 1/2 dose expansion study of lorigerlimab, a PD-1 × CTLA-4 DART® molecule. In addition, we recently dosed the first patient in a Phase 1 study of MGD024, our next-generation CD123 × CD3 DART molecule, in patients with CD123-positive hematologic malignancies,” said
Updates on Proprietary Investigational Programs
Recent progress and anticipated events in 2022 related to MacroGenics’ investigational product candidates in clinical development are highlighted below.
- MGC018 is an ADC that targets 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.
- Following constructive interactions with the
U.S. Food and Drug Administration(FDA) and European Medicines Agency, MacroGenicsexpects to start the TAMARACK Phase 2/3 study of MGC018 in patients with mCRPC by year-end. The Company believes that this should enable the delivery of interim data from the Phase 2 portion of the study by the end of 2024.
- Patient recruitment continues in a Phase 1/2 dose escalation study of MGC018 in combination with lorigerlimab in patients with various advanced solid tumors.
- Following constructive interactions with the
- Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule.
MacroGenicscompleted enrollment of a Phase 1/2 dose expansion study with lorigerlimab as monotherapy in cohorts of patients with microsatellite stable colorectal cancer, mCRPC, melanoma and checkpoint-naïve non-small cell lung cancer. The Company expects to provide a data update from this study by early 2023.
- MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing through a longer half-life.
MacroGenicsrecently dosed the first patient in a Phase 1 study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes.
- Enoblituzumab is an Fc‐engineered, monoclonal antibody (mAb) that targets B7‐H3.
- As previously announced in
July 2022, MacroGenicsclosed the Phase 2 study evaluating enoblituzumab in combination with either retifanlimab (anti-PD-1 mAb) or tebotelimab (PD-1 × LAG-3 bispecific antibody), each an investigational agent, in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The decision to discontinue this study was based on an internal review of safety data and a risk benefit analysis in front-line SCCHN patients. The Company does not believe this decision has any impact on its other B7-H3-directed programs or its ability to potentially develop enoblituzumab in other indications.
- At the 2022
American Society of Clinical Oncology(ASCO) Annual Meeting, investigators at Johns Hopkins Universitypresented encouraging clinical and safety data from their ongoing, investigator-sponsored Phase 2 trial of enoblituzumab in patients with localized prostate cancer in the neoadjuvant setting. In the 32-patient, single-arm study, enoblituzumab showed a favorable safety profile and encouraging activity with 66% of patients having PSA 0 at one-year post-surgical resection, which correlated with peripheral expansion of tumor associated T-cell clones. This published data from the ongoing investigator-sponsored trial to date provide rationale for further evaluation of enoblituzumab in prostate cancer.
- As previously announced in
Other Program Updates:
- Teplizumab is an investigational, anti-CD3 mAb acquired from
MacroGenicsby Provention Bio, Inc. (Provention) under an asset purchase agreement in 2018. Provention is developing teplizumab for the treatment of type 1 diabetes. On June 30, 2022, Provention announced that the FDA had extended its review period by three months for the biologics license application (BLA) for teplizumab. The extended Prescription Drug User Fee Act (PDUFA) target date is November 17, 2022. MacroGenicsis eligible to receive royalties on net sales of teplizumab, if approved, in addition to milestone payments, including $60 millionupon approval of a BLA in the United States.
- Retifanlimab is an investigational anti-PD-1 mAb that has been exclusively licensed to Incyte Corporation.
MacroGenicsis eligible to receive royalties on net sales of retifanlimab, if approved, in addition to milestone payments. In July 2022, MacroGenicsreceived $30 millionin milestone payments from Incyte as part of its collaboration agreement. Retifanlimab is currently being studied as monotherapy or in combination with other agents across multiple studies.
The reduction in workforce announced today will be implemented immediately in some areas and completed over time as certain projects are wound down and sites are closed. MacroGenics expects to incur additional costs as the Company recognizes one-time employee termination-related charges.
“In an effort to prioritize our pipeline of product candidates and reduce our spending, we have previously announced the termination of multiple studies. Today, we are taking additional decisive action to extend our cash runway and put
Second Quarter 2022 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities as of
June 30, 2022, were $133.7 million, compared to $243.6 millionas of December 31, 2021. The June 30, 2022balance did not include $34.5 millionin payments subsequently received from collaboration partners in July 2022.
- Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was
$26.0 millionfor the quarter ended June 30, 2022, compared to total revenue of $30.8 millionfor the quarter ended June 30, 2021. Revenue for the quarter ended June 30, 2022included MARGENZA net sales of $4.7 million, compared to $3.2 million for the quarter ended June 30, 2021.
- R&D Expenses: Research and development expenses were
$51.7 millionfor the quarter ended June 30, 2022, compared to $55.8 millionfor the quarter ended June 30, 2021. The decrease was primarily related to decreased retifanlimab manufacturing costs for Incyte and decreased costs related to discontinued studies. These decreases were partially offset by increased development of discovery projects and preclinical molecules, increased clinical expenses related to lorigerlimab, and increased costs related to MGC018.
- SG&A Expenses: Selling, general and administrative expenses were
$13.7 millionfor the quarter ended June 30, 2022, compared to $15.2 millionfor the quarter ended June 30, 2021. The decrease was primarily related to decreased selling costs for MARGENZA, which launched in March 2021, as well as decreased consulting expenses.
- Net Loss: Net loss was
$41.3 millionfor the quarter ended June 30, 2022, compared to net loss of $39.9 millionfor the quarter ended June 30, 2021.
- Shares Outstanding: Shares of common stock outstanding as of
June 30, 2022were 61,458,790.
- Cash Runway Guidance:
MacroGenicsanticipates that its cash, cash equivalents and marketable securities balance of $133.7 millionas of June 30, 2022, combined with $34.5 millionin payments subsequently received from collaboration partners, anticipated and potential collaboration payments, product revenues and savings from the execution of the Company's restructuring plan should extend its cash runway into 2024. This cash runway guidance reflects anticipated expenditures related to the planned Phase 2 portion of the MGC018 TAMARACK study as well as continuation of MacroGenics’ other ongoing preclinical and clinical studies.
Conference Call Information
To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.
The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)
|Cash, cash equivalents and marketable securities||$||133,740||$||243,616|
|Total stockholders' equity||142,481||239,618|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share data)
|Three Months Ended
||Six Months Ended
|Collaborative and other agreements||$||16,863||$||27,168||$||23,956||$||42,352|
|Product sales, net||4,672||3,203||8,252||4,090|
|Costs and expenses:|
|Cost of product sales||180||22||228||39|
|Cost of manufacturing services||2,222||—||2,222||—|
|Research and development||51,744||55,780||113,182||108,901|
|Selling, general and administrative||13,669||15,234||29,922||30,270|
|Total costs and expenses||67,815||71,036||145,554||139,210|
|Loss from operations||(41,808||)||(40,279||)||(108,446||)||(91,572||)|
|Other comprehensive income (loss):|
|Unrealized gain (loss) on investments||(43||)||(10||)||(265||)||8|
|Comprehensive income (loss)||$||(41,347||)||$||(39,945||)||$||(108,012||)||$||(91,199||)|
|Basic and diluted net loss per common share||$||(0.67||)||$||(0.66||)||$||(1.76||)||$||(1.56||)|
|Basic and diluted weighted average common shares outstanding||61,384,943||60,068,315||61,354,721||58,643,496|
About MacroGenics, Inc.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
Source: MacroGenics, Inc.