- Collaboration with Gilead to develop bispecific antibodies, including MGD024, announced
- Planned initiation of Phase 2 portion of MGC018 TAMARACK study in prostate cancer by year-end
- Anticipated update on lorigerlimab (PD-1 × CTLA-4 bispecific DART® molecule) monotherapy clinical data in first quarter of 2023
- Conference call scheduled for today at 4:30 p.m. ET
“Over the past few months, we have strengthened our financial position by generating non-dilutive capital through our partnering efforts. We have achieved this through the receipt of
Updates on Proprietary Investigational Programs
Recent progress and anticipated events related to MacroGenics’ investigational product candidates in clinical development are highlighted below.
- MGC018, now also known as vobramitamab duocarmazine, is an antibody-drug conjugate (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.
MacroGenicscontinues to expect to start the Phase 2 portion of the TAMARACK study of vobramitamab duocarmazine in patients with metastatic castration-resistant prostate cancer (mCRPC) by year-end 2022. The Company believes that this should enable interim data from the Phase 2 portion of the study in 2024.
- Patient recruitment continues in a Phase 1/2 dose escalation study of vobramitamab duocarmazine in combination with lorigerlimab in patients with various advanced solid tumors.
- Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule.
MacroGenicsenrolled 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 (NSCLC) and expects to provide a data update from this study in the first quarter of 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.
MacroGenicscontinues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes.
Other Program Updates:
- Teplizumab is an investigational, anti-CD3 mAb acquired from
MacroGenicsby Provention Bio, Inc. under an asset purchase agreement in 2018. Provention Bio is developing teplizumab for the prevention and treatment of type 1 diabetes (T1D). The Prescription Drug User Fee Act (PDUFA) target date for action on the BLA for teplizumab for the prevention of T1D 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.
Third Quarter 2022 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities as of
September 30, 2022, were $123.6 million, compared to $243.6 millionas of December 31, 2021. The September 30, 2022balance did not include $60 millionsubsequently received from Gilead in October 2022.
- Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was
$41.7 millionfor the quarter ended September 30, 2022, compared to total revenue of $15.7 millionfor the quarter ended September 30, 2021. Revenue for the quarter ended September 30, 2022included MARGENZA net sales of $4.4 million, compared to $3.6 million for the quarter ended September 30, 2021.
- R&D Expenses: Research and development expenses were
$48.2 millionfor the quarter ended September 30, 2022, compared to $49.8 millionfor the quarter ended September 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, manufacturing and clinical trial costs related to vobramitamab duocarmazine, increased expenses related to discovery projects and preclinical molecules, and increased clinical expenses related to lorigerlimab and MGD024.
- SG&A Expenses: Selling, general and administrative expenses were
$15.4 millionfor the quarter ended September 30, 2022, compared to $17.2 millionfor the quarter ended September 30, 2021. The decrease was primarily related to decreased selling costs for MARGENZA as well as decreased consulting expenses.
- Net Loss: Net loss was
$24.8 millionfor the quarter ended September 30, 2022, compared to net loss of $52.9 millionfor the quarter ended September 30, 2021.
- Shares Outstanding: Shares of common stock outstanding as of
September 30, 2022were 61,462,189.
- Cash Runway Guidance:
MacroGenicsanticipates that its cash, cash equivalents and marketable securities balance of $123.6 millionas of September 30, 2022, $60 millionsubsequently received from Gilead, projected and anticipated future payments from partners and product revenues should extend its cash runway into mid-2024. This cash runway guidance reflects anticipated expenditures related to the planned Phase 2 portion of the TAMARACK study as well as MacroGenics’ other ongoing studies.
Conference Call Information
To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.
The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)
|Cash, cash equivalents and marketable securities||$||123,616||$||243,616|
|Total stockholders' equity||122,958||239,618|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share data)
|Three Months Ended
||Nine Months Ended
|Collaborative and other agreements||$||35,674||$||11,986||$||59,630||$||54,338|
|Product sales, net||4,371||3,591||12,623||7,681|
|Costs and expenses:|
|Cost of product sales||3,007||1,665||3,235||1,704|
|Cost of manufacturing services||136||—||2,358||—|
|Research and development||48,191||49,823||161,373||158,724|
|Selling, general and administrative||15,355||17,161||45,277||47,431|
|Total costs and expenses||66,689||68,649||212,243||207,859|
|Loss from operations||(24,955||)||(52,987||)||(133,401||)||(144,559||)|
|Other comprehensive income (loss):|
|Unrealized gain (loss) on investments||213||(4||)||(52||)||4|
|Comprehensive income (loss)||$||(24,600||)||$||(52,890||)||$||(132,612||)||$||(144,089||)|
|Basic and diluted net loss per common share||$||(0.40||)||$||(0.86||)||$||(2.16||)||$||(2.42||)|
|Basic and diluted weighted average common shares outstanding||61,459,831||61,169,754||61,390,143||59,494,836|
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.