- Cash runway extended through 2025 with $250 million in non-dilutive funding over past eight months
- TAMARACK study design modified with objective of accelerating data readout
- Encouraging lorigerlimab (PD-1 × CTLA-4 bispecific DART® molecule) monotherapy clinical data presented at ASCO-GU
- Conference call scheduled for today at 4:30 p.m. ET
“Our recent presentation of encouraging, preliminary lorigerlimab data in patients with metastatic castration-resistant prostate cancer (mCRPC) at the ASCO Genitourinary Cancers Symposium, together with data we previously shared regarding vobramitamab duocarmazine in mCRPC patients, supports continued development of our two potential new treatment options for men with prostate cancer,” said
Updates on Proprietary Investigational Programs
Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below.
- Vobramitamab duocarmazine (vobra duo), formerly known as 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.
MacroGenicsinitiated the Phase 2 portion of the TAMARACK study of vobra duo in patients with mCRPC in late 2022. This study is designed to evaluate 100 patients across two experimental arms in which they receive vobra duo at either 2.0 mg/kg or 2.7 mg/kg Q4W. This study initially included a control arm in which patients received a second androgen receptor axis-targeted (ARAT) agent. The treatment landscape for patients with mCRPC has evolved with declining acceptability regarding the use of a second ARAT agent in patients who progress on earlier therapies and the approval of a radiopharmaceutical medication. Given MacroGenics’ objective to enroll TAMARACK and determine an optimal dose expeditiously, the Company has modified the trial by removing the ARAT control arm and the Phase 3 portion of the study, with regulatory approval for the modified protocol obtained to date in several countries. MacroGenicsbelieves that removal of the control arm should allow the Company to provide a clinical update in 2024 potentially in support of a subsequent Phase 3 study in mCRPC. MacroGenicscontinues to pursue a Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with various advanced solid tumors.
- Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule.
MacroGenicspresented preliminary clinical results from a dose expansion, single arm study of lorigerlimab in patients with advanced solid tumors in a poster session at the 2023 ASCO Genitourinary Cancers Symposium in February 2023. Among the data presented, 12 of 42 patients (28.6%) with mCRPC achieved ≥ 50% prostate-specific antigen (PSA) reduction (PSA50), including nine (21.4%) who achieved ≥ 90% PSA reduction (PSA90). Nine of 35 patients (25.7%) who had measurable mCRPC achieved confirmed partial responses. The overall safety profile observed across 127 patients from multiple solid tumor expansion cohorts was manageable. MacroGenicsplans to initiate a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel in second-line, chemotherapy-naïve mCRPC patients in the second half of 2023. A total of 150 patients are planned to be randomized 2:1. The current study design includes a primary study endpoint of radiographic progression-free survival (rPFS).
- 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.
- As previously announced in
October 2022, MacroGenicsand Gilead Sciences, Inc. entered into an exclusive option and collaboration agreement to develop MGD024 and up to two additional bispecific research programs. The agreement granted Gilead the option to license MGD024 at predefined decision points during the Phase 1 study.
Other Corporate Updates
- TZIELD™ (teplizumab-mzwv) approval. As previously announced in
November 2022, the FDA approved TZIELD to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D. Teplizumab was acquired from MacroGenicsby Provention Bio (Provention) in 2018, pursuant to an asset purchase agreement, as amended, with specific provisions that include:
- Provention is obligated to pay
MacroGenicsa $60 millionmilestone for this first approval, which was split into four $15 millionpayments. The first two payments were received in November 2022and March 2023and the two remaining payments are due June 1, 2023and September 1, 2023. MacroGenicsis eligible to receive additional contingent payments from Provention.
- Provention is obligated to pay
- Sale of TZIELD Royalty Interest for up to
$200 Million. As announced last week, MacroGenicssold its royalty interest in TZIELD to a wholly-owned subsidiary of DRI Healthcare Trust (DRI). MacroGenicsretains its other economic interests related to TZIELD, including future potential regulatory and commercial milestones. The Company received a $100 millionupfront payment from DRI for the sale of its single-digit royalty on global net sales of TZIELD. The Company retains the right to receive a 50% share of the royalty on global net sales above a certain annual threshold. In addition, MacroGenicsis eligible to receive up to $50 millionfrom DRI upon the occurrence of pre-specified events tied to the advancement of TZIELD for the treatment of newly diagnosed T1D and may also receive an additional $50 millionif TZIELD achieves a certain level of net sales.
- Expanded ADC Collaboration with Synaffix. In
March 2023, MacroGenicsexpanded its technology agreement with Synaffix, which will allow MacroGenicsto gain access to Synaffix’s proprietary linker-payload platform to support up to four additional ADC molecules.
- New Board Members. As previously announced in
January 2023, Dr. Margaret A. Liuand Meenu Chhabra Karsonwere appointed to MacroGenics’ Board of Directors. Dr. Liuserves as a member of MacroGenics’ Science and Technology Committeeand Ms. Karsonserves as a member of the Company’s Audit Committee. Biographical information for both new Board members can be found on the Company’s website.
2022 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities as of
December 31, 2022, were $154.3 million, compared to $243.6 millionas of December 31, 2021. This cash balance did not include the $45 millionreceivable due from Provention or the recent $100 millionpayment from DRI.
- Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was
$151.9 millionfor the year ended December 31, 2022, compared to total revenue of $77.4 millionfor the year ended December 31, 2021.
- R&D Expenses: Research and development expenses were
$207.0 millionfor the year ended December 31, 2022, compared to $214.6 millionfor the year ended December 31, 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
$58.9 millionfor the year ended December 31, 2022, compared to $63.0 millionfor the year ended December 31, 2021. The decrease was primarily related to decreased selling costs for MARGENZA as well as decreased legal, consulting and stock-based compensation expenses.
- Net Loss: Net loss was
$119.8 millionfor the year ended December 31, 2022, compared to net loss of $202.1 millionfor the year ended December 31, 2021.
- Shares Outstanding: Shares of common stock outstanding as of
December 31, 2022were 61,701,467.
- Cash Runway Guidance:
MacroGenicsanticipates that its cash, cash equivalents and marketable securities balance of $154.3 millionas of December 31, 2022, plus the $100 millionproceeds received from DRI related to the sale of the Company’s TZIELD royalty interest, projected and anticipated future payments from partners and product revenues should extend its cash runway through 2025. The Company’s expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial, the planned Phase 2 study of lorigerlimab in mCRPC as well as MacroGenics’ other clinical and preclinical studies currently ongoing.
Conference Call Information
To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.
The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)
|Cash, cash equivalents and marketable securities||$||154,346||$||243,616|
|Total stockholders' equity||142,013||239,618|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share data)
|Collaborative and other agreements||$||119,303||$||63,294||$||97,764|
|Product sales, net||16,727||12,349||—|
|Costs and expenses:|
|Cost of product sales||3,351||2,651||—|
|Cost of manufacturing services||4,033||—||—|
|Research and development||207,026||214,577||193,201|
|Selling, general and administrative||58,949||63,014||42,742|
|Total costs and expenses||273,359||280,242||235,943|
|Loss from operations||(121,418||)||(202,795||)||(131,060||)|
|Other comprehensive income (loss):|
|Unrealized gain (loss) on investments||56||(54||)||(23||)|
|Basic and diluted net loss per common share||$||(1.95||)||$||(3.37||)||$||(2.47||)|
|Basic and diluted weighted average common shares outstanding||61,433,124||$||59,944,717||52,442,389|
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.