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MGNX - MacroGenics Inc News Story

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Mid Cap
Market Cap £581.5m
Enterprise Value £359.8m
Revenue £86.0m
Position in Universe 3090th / 7414

MacroGenics Provides Update on Corporate Progress and Third Quarter 2021 Financial Results

Tue 2nd November, 2021 8:01pm
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* Investigational New Drug (IND) application submitted for MGD024, a next
generation DART(®) molecule targeting CD123 and CD3 for AML
* U.S. Food & Drug Administration (FDA) approves MacroGenics’ GMP
manufacturing facility to produce MARGENZA(®) drug substance 
* Discontinuing enrollment of Cohort A of Phase 2/3 MAHOGANY study of
* Conference call scheduled for today at 4:30 p.m. ET.
ROCKVILLE, Md., Nov. 02, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:
MGNX), a biopharmaceutical company focused on developing and commercializing
innovative monoclonal 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 September 30, 2021.

“In September, we were pleased to present encouraging preliminary results
from our ongoing Phase 1 cohort expansion study of MGC018 at the European
Society for Medical Oncology (ESMO) Annual Meeting. We look forward to
providing additional clinical data updates on this study next year as well as
sharing our future development plans for this molecule in the first quarter of
next year, after continued engagement with Key Opinion Leaders and regulatory
agencies,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics.
“Beyond MGC018, we continue to advance our growing pipeline of
investigational product candidates for the potential treatment of cancer.
Finally, the recent FDA approval to manufacture MARGENZA drug substance at our
GMP manufacturing facility is an important achievement for the Company.”

Updates on Proprietary Programs

The recent progress and key events related to MacroGenics’ investigational
product candidates in clinical development and its approved product, MARGENZA,
are highlighted below:
* MGC018 is an antibody-drug conjugate (ADC) that targets B7-H3. At ESMO,
MacroGenics presented encouraging preliminary clinical results from the
ongoing Phase 1 study of MGC018 in patients with solid tumors. The Phase 1
study cohort expansions are ongoing for metastatic castrate-resistant prostate
cancer (mCRPC), non-small cell lung cancer (NSCLC), melanoma, squamous cell
carcinoma of the head and neck (SCCHN) and triple negative breast cancer
(TNBC). The Company expects to present additional data from the ongoing Phase
1 study of MGC018 in the first half of next year. In addition, MacroGenics
intends to provide details regarding further development plans in mCRPC in the
first quarter of 2022. The Company also intends to initiate a study combining
MGC018 with one of its proprietary checkpoint inhibitor molecules in the first
half of next year. 

* Enoblituzumab is an Fc‐engineered, monoclonal antibody that targets
B7‐H3. MacroGenics continues to recruit patients into its Phase 2 study of
enoblituzumab in a chemotherapy-free regimen in combination with retifanlimab
in front-line patients with SCCHN who are PD-L1 positive and with tebotelimab
in SCCHN patients who are PD-L1 negative. In September, I-Mab Biopharma
announced that an IND to initiate a Phase 2 trial of enoblituzumab in
combination with pembrolizumab in patients with select solid tumors was
accepted in China, triggering a net $4.5 million milestone payment to
MacroGenics. I-Mab has development and commercial rights to enoblituzumab in
Greater China. 

* Bispecific CD123 × CD3 DART molecules: 

 * Flotetuzumab is a bispecific CD123 × CD3 DART molecule being evaluated
in patients with refractory acute myeloid leukemia (AML). MacroGenics is
conducting a single-arm clinical study to evaluate flotetuzumab in up to 200
patients with refractory AML, with complete remission (CR) and CR with partial
hematological recovery (CRh) as the composite primary endpoint. The Company
anticipates providing further updates on the clinical development of
flotetuzumab in 2022.

* MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule designed
to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic
activity, and has an Fc domain to permit intermittent dosing through a longer
half-life. MacroGenics submitted an IND application for MGD024 to the FDA in
October. The Company intends to present preclinical MGD024 data at the
American Society of Hematology (ASH) Annual Meeting in December. 

* Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and
LAG-3. MacroGenics is evaluating the molecule in patients as monotherapy as
well as in combination with other agents. The Company’s partner for this
molecule in Greater China, Zai Lab, expanded its Phase 1b/2 study of
tebotelimab in combination with the PARP inhibitor niraparib into new
indications, including gastric cancer, TNBC and biliary tract cancer. In
addition, Zai Lab enrolled the first patient in an endometrial cancer cohort
in October 2021. 

* MGD019 is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4.
The Company is conducting a Phase 1 dose expansion study in cohorts of
patients with microsatellite stable colorectal cancer (MSS CRC),
checkpoint-naïve NSCLC, mCRPC and melanoma. The Company anticipates sharing
data from its ongoing Phase 1 dose expansion study next year. 

* IMGC936 is an ADC that targets ADAM9, a cell surface protein over-expressed
in several solid tumor types, and is being developed jointly under a 50/50
collaboration with ImmunoGen, Inc. Under the collaboration, ImmunoGen is
leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating
safety and pharmacokinetics in multiple solid tumors and has indicated they
anticipate disclosing initial data in 2022. 

* Margetuximab is an Fc-engineered, monoclonal antibody (mAb) that targets
the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal
and other solid tumor cells. 

 * MARGENZA Commercial Launch. In March 2021, MacroGenics and its commercial
partner, EVERSANA, launched MARGENZA for the treatment of adult patients with
metastatic HER2-positive breast cancer, in combination with chemotherapy, who
have received two or more prior anti-HER2 regimens, at least one of which was
for metastatic disease. As previously reported, the median overall survival
(OS) in the intent-to-treat population was not statistically different between
the two arms. A prespecified, non-alpha allocating, exploratory analysis of OS
by CD16A genotype in the SOPHIA trial showed a numerical OS advantage in favor
of margetuximab in F homozygous patients and a numerical OS advantage in favor
of trastuzumab in V homozygous patients. Finally, MacroGenics recently
received U.S. FDA approval to manufacture MARGENZA drug substance at its GMP
manufacturing facility in Rockville, MD.

* MAHOGANY Study. At ESMO, MacroGenics presented results from Cohort A Part 1
of the Phase 2/3 MAHOGANY study of margetuximab in combination with
retifanlimab, an anti-PD-1 molecule the Company licensed to Incyte
Corporation, in patients with advanced gastric and gastroesophageal junction
cancer. Although the number of confirmed responses by independent review
(twenty one of 40 (53%) patients) exceeded the prespecified futility boundary
for this chemotherapy-free regimen, MacroGenics has decided to discontinue
enrollment of Cohort A based on a number of factors, including the
prioritization of its other product candidates given the competition in this
indication, and the accelerated approval of combination therapy with
pembrolizumab. MacroGenics’ partner for margetuximab in Greater China, Zai
Lab, continues to enroll patients in Cohort B. 

* Zai Lab’s Bridging Study. In October 2021, Zai Lab announced that the
bridging study of margetuximab plus chemotherapy in advanced, previously
treated HER2-positive breast cancer met its primary endpoint with acceptable
safety and tolerability. The study showed that efficacy of the combination in
Chinese patients was consistent with that seen in the global population in
MacroGenics’ SOPHIA Phase 3 trial. Zai Lab has indicated that it anticipates
submitting a BLA in China for pretreated metastatic HER2-positive breast
cancer by approximately year-end 2021.
Updates on Partnered Program
* Retifanlimab is an investigational anti-PD-1 antibody that MacroGenics
licensed to Incyte. Incyte will present clinical results in poster
presentations from both a Phase 2 study of retifanlimab in patients with
advanced or metastatic Merkel cell carcinoma and a tumor specific expansion
cohort study in patients with recurrent MSI-H or deficient mismatch repair
(dMMR) recurrent endometrial cancer at the 2021 Society for Immunotherapy of
Cancer (or SITC) Virtual Meeting taking place November 10 - 14, 2021.
Third Quarter 2021 Financial Results
* Cash Position: Cash, cash equivalents and marketable securities as of
September 30, 2021, were $298.9 million, compared to $272.5 million as of
December 31, 2020.
* Revenue: Total revenue, consisting primarily of revenue from collaborative
agreements, was $15.7 million for the quarter ended September 30, 2021,
compared to total revenue of $18.3 million for the quarter ended
September 30, 2020. Revenue for the quarter ended September 30, 2021
included $3.6 million net sales of MARGENZA.
* R&D Expenses: Research and development expenses were $49.8 million for the
quarter ended September 30, 2021, compared to $44.7 million for the quarter
ended September 30, 2020. The increase was primarily related to increased
clinical trial and development costs related to the Company’s product
candidates, as well as research costs related to preclinical molecules,
partially offset by decreased clinical costs and BLA support for margetuximab
and decreased development and manufacturing costs related to flotetuzumab.
* SG&A Expenses: Selling, general and administrative expenses were $17.2
million for the quarter ended September 30, 2021, compared to $9.7 million
for the quarter ended September 30, 2020. The increase was primarily related
to MARGENZA launch, as well as labor-related costs and legal expenses.
* Net Loss: Net loss was $52.9 million for the quarter ended September 30,
2021, compared to net loss of $36.0 million for the quarter ended
September 30, 2020.
* Shares Outstanding: Shares outstanding as of September 30, 2021 were
* Cash Runway Guidance: MacroGenics anticipates that its cash, cash
equivalents and marketable securities as of September 30, 2021, plus
anticipated and potential collaboration payments, should enable it to fund its
operations through 2023, assuming the Company’s programs and collaborations
advance as currently contemplated.
Conference Call Information

MacroGenics will host a conference call today at 4:30 p.m. (ET) to discuss
financial results for the quarter ended September 30, 2021 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: 6063045.

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 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.

(Amounts in thousands)

                                                   September 30, 2021           December 31, 2020        
 Cash, cash equivalents and marketable securities  $        298,898             $       272,531          
 Total assets                                      392,160                      378,743                  
 Deferred revenue                                  25,889                       11,382                   
 Total stockholders' equity                        291,438                      295,884                  


(Amounts in thousands, except share and per share data)

                                                               Three Months Ended September 30,                                  Nine Months Ended September 30,                                   
                                                               2021                               2020                           2021                                2020                          
 Revenue from collaborative and other agreements               $       11,986                     $       17,415                 $       54,338                      $       46,018                
 Product revenue, net                                          3,591                              —                              7,681                               —                             
 Revenue from government agreements                            85                                 838                            1,281                               6,174                         
 Total revenues                                                15,662                             18,253                         63,300                              52,192                        
 Costs and expenses:                                                                                                                                                                               
 Cost of product sales                                         1,665                              —                              1,704                               —                             
 Research and development                                      49,823                             44,656                         158,724                             150,901                       
 Selling, general and administrative                           17,161                             9,732                          47,431                              30,181                        
 Total costs and expenses                                      68,649                             54,388                         207,859                             181,082                       
 Loss from operations                                          (52,987          )                 (36,135          )             (144,559          )                 (128,890          )           
 Other income                                                  101                                92                             466                                 1,238                         
 Net loss                                                      (52,886          )                 (36,043          )             (144,093          )                 (127,652          )           
 Other comprehensive income:                                                                                                                                                                       
 Unrealized gain (loss) on investments                         (4               )                 (15              )             4                                   (14               )           
 Comprehensive loss                                            $       (52,890  )                 $       (36,058  )             $       (144,089  )                 $       (127,666  )           
 Basic and diluted net loss per common share                   $       (0.86    )                 $       (0.66    )             $       (2.42     )                 $       (2.49     )           
 Basic and diluted weighted average common shares outstanding  61,169,754                         54,463,412                     59,494,836                          51,176,884                    

About MacroGenics, Inc.

MacroGenics 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 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 the Company, including statements about the Company's strategy,
future operations, clinical development of the Company's therapeutic
candidates, commercial prospects of or product revenues from MARGENZA,
milestone or opt-in payments from the Company's collaborators, the Company's
anticipated milestones and other statements containing the words "subject to",
"believe", "anticipate", "plan", "expect", "intend", "estimate", "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 MARGENZA revenue, expenses and costs may not be as
expected, risks relating to MARGENZA’s market acceptance, competition,
reimbursement and regulatory actions, the uncertainties inherent in the
initiation and enrollment of future clinical trials, expectations of expanding
ongoing clinical trials, availability and timing of data from ongoing clinical
trials, expectations for regulatory approvals, other matters that could affect
the availability or commercial potential of the Company's product candidates
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.

Chris James, M.D., Vice President, Investor Relations & Corporate
Jim Karrels, Senior Vice President, CFO 

GlobeNewswire, Inc. 2021
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