On May 7, 2018 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer,reported financial results for the quarter ended March 31, 2018 (Press release, MacroGenics, MAY 7, 2018, View Source [SID1234526169]).

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"Our momentum continues to build in 2018, as our multiple product candidates advance toward data read-outs," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "During the first quarter, margetuximab passed an interim futility analysis for the SOPHIA Phase 3 metastatic breast cancer study. We also presented clinical data for the combination of margetuximab with an anti-PD-1 agent showing encouraging activity in the treatment of gastric cancer patients in a Phase 2 study. We plan to provide an update on this study, including presentation of biomarker data, at the upcoming ASCO (Free ASCO Whitepaper) meeting. During the second half of the year, we expect to provide clinical updates on both flotetuzumab in patients with relapsed/refractory acute myeloid leukemia (AML), and on the combination of enoblituzumab with an anti-PD-1 agent. In addition, we anticipate that two of our oncology product candidates will move into our clinical pipeline this year: MGD019 (PD-1 x CTLA-4 DART molecule) and MGC018 (B7-H3 ADC), the planned investigational new drug (IND) application submissions for which are both on track."

Key Pipeline Updates

Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody (mAb) that targets the human epidermal growth factor receptor 2, or HER2, include:

Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. In January 2018, the Company announced the completion of a pre-planned interim futility analysis with the recommendation of an independent data safety monitoring committee to continue SOPHIA as planned without modification. This analysis was based on a pre-specified assessment of progression-free survival as determined by independent central review. The Company also announced that the U.S. FDA had granted Fast Track designation for the investigation of margetuximab for treatment of patients with metastatic or locally advanced HER2 positive breast cancer who have previously been treated with anti-HER2-targeted therapy. MacroGenics remains on track to complete enrollment of the study in the fourth quarter of 2018, with anticipated disclosure of topline progression-free survival data in the first half of 2019.

Phase 2 Gastric Cancer Study. In January 2018, MacroGenics presented interim clinical data from a Phase 2 study of margetuximab plus an anti-PD-1 agent in patients with gastric and gastroesophageal junction (GEJ) cancer. These results included encouraging tolerability and anti-tumor activity in a subpopulation of 25 gastric cancer patients. Based on these results, MacroGenics expanded the study and is enrolling 25 additional gastric cancer patients. The Company will present updated clinical and biomarker data at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting in June.

Exhibit 99.1

Flotetuzumab. Recent highlights of the Company’s bispecific, humanized DART molecule that recognizes both CD123 and CD3, include:

Monotherapy Study. MacroGenics has completed the enrollment of its AML dose expansion cohort. The Company anticipates presenting updated clinical data and defining a potential registration path during the second half of 2018. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Korea and India for flotetuzumab, also known as S80880.

Planned Combination Study with an anti-PD-1. MacroGenics has previously presented data supporting the rationale for using checkpoint blockade as an approach to potentially enhance the anti-leukemic activity of flotetuzumab. MacroGenics intends to initiate a combination study with INCMGA0012, an anti-PD-1 mAb also known as MGA012, during the third quarter of 2018.
Other Pipeline Assets Update
Additional programs that the Company is advancing include the following:
PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing multiple PD-1-directed programs to enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. These programs include:

INCMGA0012. INCMGA0012 is a humanized, proprietary anti-PD-1 mAb being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. INCMGA0012 was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. MacroGenics transferred the INCMGA0012 U.S. IND to Incyte during the first quarter of 2018.

MGD013. MacroGenics designed a DART molecule, MGD013, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of solid tumors and hematological malignancies. MGD013 is currently being evaluated in a Phase 1 dose escalation study. MacroGenics expects to establish the dose and schedule for MGD013 administration as well as initiate dose expansion cohorts in the second half of 2018.

MGD019. This DART molecule is designed to provide co-blockade of both PD-1 and CTLA-4 on T cells. The Company is completing IND-enabling studies and anticipates submitting the IND application for MGD019 in the second half of 2018.
B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. These molecules include:

Enoblituzumab: The Company completed the recruitment of patients with four solid tumor types in an ongoing study of this Fc-optimized mAb that targets B7-H3, in combination with an anti-PD-1 mAb and expects to present clinical data from this study in the second half of 2018.

MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types. The Company expects to establish the dose and schedule for MGD009 administration as well as initiate monotherapy dose expansion cohorts in the second half of 2018. In addition, a combination study of MGD009 and INCMGA0012 was initiated during the first quarter of 2018.

Exhibit 99.1

MGC018: The Company is completing IND-enabling activities to support submission of an IND application for this anti-B7-H3 antibody drug conjugate (ADC) and anticipates initiation of a Phase 1 study in the second half of 2018.
Additional DART Clinical Programs. Additional DART molecules in Phase 1 clinical development being led by MacroGenics include the following:

MGD007. The Company recently completed a monotherapy study of MGD007, a DART molecule that recognizes gpA33 and CD3, and anticipates commencing a combination study with INCMGA0012 in the second quarter of 2018.

MGD014. MacroGenics’ first DART molecule designed to target an infectious agent, MGD014 recognizes the envelope protein of HIV-infected cells (Env) and the T cells’ CD3 component, to redirect the immune system’s T cells to kill HIV-infected cells. The Company expects to commence the Phase 1 study during the second quarter of 2018.

Corporate Update

Roche Collaboration. In January 2018, MacroGenics announced that it had entered into a research collaboration and license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche) to jointly discover and develop novel bispecific molecules to undisclosed targets. MacroGenics received an upfront payment of $10 million from Roche in January 2018 and is eligible to receive potential milestone payments and royalties on future sales.

GMP Manufacturing Suite Build-out: The Company is expanding its manufacturing capacity by completing the build-out of a GMP suite in its headquarters building in Rockville, Maryland to support larger-scale clinical and commercial manufacturing. MacroGenics expects to commence GMP production runs in this facility in the third quarter of 2018.

Common Stock Financing. On April 2, 2018, the Company closed its public offering of 5,175,000 shares of common stock. Net proceeds to MacroGenics, after deducting underwriting discounts and commissions and offering expenses, were $103 million.
First Quarter 2018 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2018, were $260.1 million, compared to $305.1 million as of December 31, 2017.

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $4.7 million for the quarter ended March 31, 2018, compared to $2.1 million for the quarter ended March 31, 2017. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.

R&D Expenses: Research and development expenses were $45.7 million for the quarter ended March 31, 2018, compared to $32.8 million for the quarter ended March 31, 2017. This increase was primarily due to the continued enrollment in the Company’s two margetuximab studies and the INCMGA0012 monotherapy clinical trial.

G&A Expenses: General and administrative expenses were $9.2 million for the quarter ended March 31, 2018, compared to $7.5 million for the quarter ended March 31, 2017. This increase

Exhibit 99.1

was primarily due to consulting and other costs incurred related to the implementation of the Company’s new enterprise resource planning (ERP) system.
Net Loss: Net loss was $49.5 million for the quarter ended March 31, 2018, compared to net loss of $37.7 million for the quarter ended March 31, 2017.

Shares Outstanding: Shares outstanding as of March 31, 2018 were 37,024,623.

Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended March 31, 2018 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: 1647389.
The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source 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.

On May 7, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has approved DARZALEX (daratumumab) in combination with VELCADE (bortezomib)*, a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone – VMP –for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) (Press release, Johnson & Johnson, MAY 7, 2018, View Source [SID1234526259]). DARZALEX is the first monoclonal antibody approved for newly diagnosed patients with this disease. Clinical trial results showed DARZALEX in combination with VMP reduced the risk of disease progression or death by 50 percent compared to treatment with VMP alone.

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"This approval is significant as we now have the first antibody-based regimen for treating newly diagnosed multiple
myeloma patients who are not eligible for a stem cell transplant," said Andrzej Jakubowiak, M.D., Ph.D., Director of
the Multiple Myeloma Program at University of Chicago Medical Center, Chicago, Illinois and a DARZALEX
clinical study investigator. "In clinical studies, patients who received treatment with daratumumab experienced a
lower risk of disease progression and higher rates of response."

The FDA approval of DARZALEX in combination with VMP is supported by data from the randomized, open-label,
multicenter Phase 3 ALCYONE (MMY3007) study, recently published in the New England Journal of Medicine.
The combination of DARZALEX with VMP reduced the risk of disease progression or death by 50 percent,
compared to treatment with VMP alone (Hazard Ratio [HR] = 0.50; 95 percent CI [0.38-0.65], p<0.0001).1 The
median progression-free survival (PFS) for DARZALEX-VMP had not yet been reached, compared to a median
PFS of 18.1 months for patients who received VMP alone.1

"A patient’s best chance at lasting remission often begins with a durable response to frontline therapy, because
multiple myeloma can become more difficult to treat after relapse," said Maria-Victoria Mateos, M.D., Ph.D.,
Director of the Myeloma Unit at University Hospital of Salamanca-IBSAL, Salamanca, Spain and ALCYONE
primary investigator. "Combination therapy with daratumumab resulted in deep and durable responses in newly
diagnosed patients with multiple myeloma who are transplant ineligible, supporting this regimen as an important
new treatment option for these patients."

Treatment with DARZALEX in combination with VMP significantly improved overall response rates (91 vs. 74
percent) compared to VMP alone.
1 Additionally, measures of stringent complete response (18 vs. 7 percent),
complete response or better (43 vs. 24 percent) and very good partial response or better (71 vs. 50 percent) all
showed marked improvement.
1 Patients receiving DARZALEX in combination with VMP achieved a more than
three-fold increase in the minimal residual disease (MRD) negativity rate (22 vs. 6 percent) compared to those who
received VMP alone.1
In the ALYCONE study, the most frequent adverse reactions (>20 percent) with at least 5 percent greater
frequency in the DARZALEX
-VMP arm were upper respiratory tract infection (48 vs. 28 percent), infusion
reactions (28 vs. 0 percent) and peripheral edema (21 vs. 14 percent).1 Serious adverse reactions with at least a 2
percent greater incidence in the DARZALEX
-VMP arm vs. VMP were pneumonia (11 vs. 4 percent), upper
respiratory tract infection (5 vs.1 percent) and pulmonary edema (2 vs. 0 percent).1 The most common Grade 3/4
treatment-emergent hematology laboratory abnormalities for DARZALEX
-VMP vs. VMP were lymphopenia (58 vs.
53 percent), neutropenia (44 vs. 43 percent) and thrombocytopenia (38 vs. 42 percent).
1 The warnings and
precautions for DARZALEX include infusion reactions, interference with cross-matching and red blood cell
antibody screening, neutropenia and thrombocytopenia (see Important Safety Information).1
"Slowing the progression of myeloma translates to more time in remission for those battling the disease. This latest
approval for DARZALEX in combination with VMP is an exciting step forward for newly diagnosed patients and
the healthcare teams who treat them," said Paul Giusti, President and CEO of the Multiple Myeloma Research
Foundation (MMRF). "The MMRF congratulates Janssen, our long-time collaborator in myeloma research, the
3
dedicated healthcare providers in the myeloma community as well as the patients who donate their time and data
on clinical trials, for making this critical new combination therapy possible."
Today’s FDA approval marks the fifth indication for DARZALEX
, the first CD38-directed antibody approved
anywhere in the world and the first antibody approved for newly diagnosed patients with multiple myeloma who are
transplant ineligible.
1 DARZALEX was first approved by the FDA in November 2015 as a monotherapy for
patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an
immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent.2 DARZALEX
received additional approvals in November 2016 in combination with lenalidomide and dexamethasone, or
bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least
one prior therapy.3 In June 2017, DARZALEX received approval in combination with pomalidomide and
dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies,
including lenalidomide and a PI.4
"We are grateful to the patients and physicians who participated in the clinical program that enabled today’s
important approval of DARZALEX combination therapy as a treatment option for newly diagnosed patients with
multiple myeloma who are transplant ineligible," said Peter Lebowitz, M.D., Ph.D, Global Therapeutic Area Head,
Oncology, Janssen Research & Development, LLC. "DARZALEX has redefined how we approach the treatment
of multiple myeloma, and we continue to evaluate its potential in combination with other regimens, with the aim of
arresting the disease at its earliest stages."
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen
an exclusive license to develop, manufacture and commercialize DARZALEX
.
5 Janssen Biotech, Inc.
commercializes DARZALEX in the U.S. For full Prescribing Information, please visit www.DARZALEX.com.
About DARZALEX (daratumumab) Injection, for Intravenous Infusion
DARZALEX (daratumumab) injection for intravenous use is the first CD38-directed antibody approved anywhere
in the world.1 CD38 is a surface protein that is highly expressed across multiple myeloma cells, regardless of
disease stage.6 DARZALEX is believed to induce tumor cell death through multiple immune-mediated
mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated
cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which
a series of molecular steps in a cell lead to its death.1 Subsets of myeloid derived suppressor cells (MDSCs),
CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by DARZALEX
.
1 DARZALEX is
being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple
myeloma, such as in frontline and relapsed settings.
7,8,9,10,11,12,13,14 Additional studies are ongoing or planned to
assess its potential in other malignant and pre-malignant hematologic diseases in which CD38 is expressed, such
4
as smoldering myeloma, as well as in solid tumors.
15,16,17 DARZALEX is the first and only CD38-directed antibody
to receive regulatory approval to treat multiple myeloma.1
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the
bone marrow.18,19 Refractory cancer occurs when a patient’s disease is resistant to treatment or in the case of
multiple myeloma, patients progress within 60 days of their last therapy.20,21 Relapsed cancer means the disease
has returned after a period of initial, partial or complete remission.22 In 2018, it is estimated that 30,700 people will
be diagnosed and 12,770 will die from the disease in the United States.23 While some patients with multiple
myeloma have no symptoms at all, most patients are diagnosed due to symptoms, which can include bone fracture
or pain, low red blood counts, fatigue, calcium elevation, kidney problems or infections.24
IMPORTANT SAFETY INFORMATION1
CONTRAINDICATIONS – None
WARNINGS AND PRECAUTIONS
Infusion Reactions – DARZALEX can cause severe infusion reactions. Approximately half of all patients
experienced a reaction, most during the first infusion. Infusion reactions can also occur with subsequent
infusions. Nearly all reactions occurred during infusion or within 4 hours of completing an infusion. Prior to the
introduction of post-infusion medication in clinical trials, infusion reactions occurred up to 48 hours after infusion.
Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, laryngeal edema
and pulmonary edema. Signs and symptoms may include respiratory symptoms, such as nasal congestion,
cough, throat irritation, as well as chills, vomiting and nausea. Less common symptoms were wheezing, allergic
rhinitis, pyrexia, chest discomfort, pruritus, and hypotension.
Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during
the entire infusion. Interrupt infusion for reactions of any severity and institute medical management as needed.
Permanently discontinue therapy for life-threatening (Grade 4) reactions. For patients with Grade 1, 2, or 3
reactions, reduce the infusion rate when re-starting the infusion.
To reduce the risk of delayed infusion reactions, administer oral corticosteroids to all patients following
DARZALEX infusions. Patients with a history of chronic obstructive pulmonary disease may require additional
post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting
bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease.
5
Interference with Serological Testing – Daratumumab binds to CD38 on red blood cells (RBCs) and results in
a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin
test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks
detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh
blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and
inform blood banks that a patient has received DARZALEX. Type and screen patients prior to starting
DARZALEX.
Neutropenia – DARZALEX may increase neutropenia induced by background therapy. Monitor complete blood
cell counts periodically during treatment according to manufacturer’s prescribing information for background
therapies. Monitor patients with neutropenia for signs of infection. DARZALEX dose delay may be required to
allow recovery of neutrophils. No dose reduction of DARZALEX is recommended. Consider supportive care with
growth factors.
Thrombocytopenia – DARZALEX may increase thrombocytopenia induced by background therapy. Monitor
complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for
background therapies. DARZALEX dose delay may be required to allow recovery of platelets. No dose reduction
of DARZALEX is recommended. Consider supportive care with transfusions.
Interference with Determination of Complete Response – Daratumumab is a human IgG kappa monoclonal
antibody that can be detected on both, the serum protein electrophoresis (SPE) and immunofixation (IFE)
assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination
of complete response and of disease progression in some patients with IgG kappa myeloma protein.
Adverse Reactions –
In patients who received DARZALEX in combination with bortezomib, melphalan, and prednisone, the most
frequently reported adverse reactions (incidence ≥20%) were: upper respiratory tract infection (48%), infusion
reactions (28%), and peripheral edema (21%). Serious adverse reactions (≥2% greater compared to the VMP
arm) were pneumonia (11%), upper respiratory tract infection (5%), and pulmonary edema (2%). Treatment
emergent grade 3-4 hematology laboratory abnormalities ≥20% were thrombocytopenia (38%), neutropenia
(44%), and lymphopenia (58%).
In patients who received DARZALEX in combination with lenalidomide and dexamethasone, the most frequently
reported adverse reactions (incidence ≥20%) were: neutropenia (92%), thrombocytopenia (73%), upper
respiratory tract infection (65%), infusion reactions (48%), diarrhea (43%), fatigue (35%), cough (30%), muscle
spasms (26%), nausea (24%), dyspnea (21%) and pyrexia (20%). The overall incidence of serious adverse
6
reactions was 49%. Serious adverse reactions were pneumonia (12%), upper respiratory tract infection (7%),
influenza (3%) and pyrexia (3%).
In patients who received DARZALEX in combination with bortezomib and dexamethasone, the most frequently
reported adverse reactions (incidence ≥20%) were: thrombocytopenia (90%), neutropenia (58%), peripheral
sensory neuropathy (47%), infusion reactions (45%), upper respiratory tract infection (44%), diarrhea (32%),
cough (27%), peripheral edema (22%), and dyspnea (21%). The overall incidence of serious adverse reactions
was 42%. Serious adverse reactions were upper respiratory tract infection (5%), diarrhea (2%) and atrial
fibrillation (2%).
In patients who received DARZALEX as monotherapy, the most frequently reported adverse reactions
(incidence ≥20%) were: neutropenia (60%), thrombocytopenia (48%), infusion reactions (48%), fatigue (39%),
nausea (27%), back pain (23%), pyrexia (21%), cough (21%), and upper respiratory tract infection (20%).
Serious adverse reactions were reported in 51 (33%) patients. The most frequent serious adverse reactions
were pneumonia (6%), general physical health deterioration (3%), and pyrexia (3%).
In patients who received DARZALEX in combination with pomalidomide and dexamethasone, the most frequent
adverse reactions (≥20%) were infusion reactions (50%), diarrhea (38%), constipation (33%), nausea (30%),
vomiting (21%), fatigue (50%), pyrexia (25%), upper respiratory tract infection (50%), muscle spasms (26%),
back pain (25%), arthralgia (22%), dizziness (21%), insomnia (23%), cough (43%) and dyspnea (33%). The
overall incidence of serious adverse reactions was 49%. Serious adverse reactions reported in ≥5% patients
included pneumonia (7%).
DRUG INTERACTIONS
Effect of Other Drugs on daratumumab: The coadministration of lenalidomide, pomalidomide or bortezomib with
DARZALEX did not affect the pharmacokinetics of daratumumab.
Effect of Daratumumab on Other Drugs: The coadministration of DARZALEX with bortezomib or pomalidomide
did not affect the pharmacokinetics of bortezomib.

On May 7, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) and CrystalGenomics, Inc. (KOSDAQ:083790) reported that Aptose exercised its option under the 2016 Option Agreement to exclusively license CG-806, a first-in-class, non-covalent pan-inhibitor of the Bruton’s tyrosine kinase (BTK) and FMS-like tyrosine kinase 3 (FLT3) from CrystalGenomics, Inc (Press release, Aptose Biosciences, MAY 7, 2018, View Source;p=RssLanding&cat=news&id=2347268 [SID1234526152]). CG-806 is being developed as a highly potent, oral small molecule for acute myeloid leukemia (AML), B-Cell malignancies and other hematologic malignancies.

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With the early exercise of the option, Aptose owns global rights to develop and commercialize CG-806 for all indications outside of Korea and China – the Licensed Territory. The exercise triggers a payment of US $2.0 million to CrystalGenomics. CrystalGenomics is eligible for regulatory and sales milestone payments, as well as royalties on product sales in the Licensed Territory.

Aptose has been conducting Investigational New Drug (IND) enabling studies with CG-806, as well as numerous preclinical studies. When tested against fresh bone marrow samples from patients with AML, CG-806 demonstrated superior potency and range of activity relative to all other FLT3 inhibitors evaluated. Likewise, CG-806 demonstrated superiority over ibrutinib when tested against samples from CLL patients. The superior potency and breadth of activity against patient-derived hematologic malignancy cells is due to the ability of CG-806 to target all wild type (WT) and all known mutant forms of FLT3 and BTK, and to suppress multiple signaling pathways that can rescue hematologic cancers from other agents. Once-daily oral dosing of CG-806 in murine xenograft models of human hematologic malignancies demonstrated tumor eradication in the absence of observable toxicity, and dose range finding studies have shown CG-806 to have a robust safety profile. Aptose expects to submit an IND in late 2018 and initiate clinical trials immediately thereafter.

"CG-806 has the potential to serve as a transformational agent for AML, chronic lymphocytic leukemia (CLL) and other hematologic malignancies," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Recent pre-clinical studies, just highlighted at the 2018 AACR (Free AACR Whitepaper) Annual Meeting, demonstrated CG-806’s superior potential to other FLT3 inhibitors on AML patient samples and superior potential to ibrutinib on CLL patient samples."

"Aptose has made the clinical development of CG-806 a priority, and we are pleased to be working with them," said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics. "Aptose and its clinical advisors clearly recognize the potential of CG-806 as an exciting therapeutic option for patients with AML, CLL and other malignancies."

About CrystalGenomics

CrystalGenomics, Inc. is a commercial stage biopharmaceutical company focused in the structure-based drug discovery and development of novel therapeutics in unmet medical need areas of inflammation, oncology, and infectious disease. In addition to several drug programs in the R&D pipeline, the Company has an osteoarthritis drug on the market and, has recently added commercial manufacturing capabilities through acquisitions. For more information, please visit: www.cgxinc.com or www.crystalgenomics.com. CrystalGenomics, Inc. is listed on KOSDAQ (083790)

On May 7, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage oncology company, reported financial results for the first quarter ended March 31, 2018 (Press release, Mirati, MAY 7, 2018, View Source [SID1234526170]).

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"We have made significant progress in all of our programs and continue to be encouraged by positive clinical results for sitravatinib and mocetinostat with planned data presentations at a fall oncology conference," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "Additionally, we are on track to file our planned Investigational New Drug application (IND) for MRTX849, a potent and selective inhibitor for KRAS, in the fourth quarter of 2018."

Financial Results for the First Quarter 2018

Cash, cash equivalents, and short-term investments were $148.7 million at March 31, 2018, compared to $150.8 million at December 31, 2017.

License and collaboration revenues for the first quarter of 2018 were $9.5 million, compared to none in the same period in 2017. License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd. ("BeiGene"), which became effective January 7, 2018, under which the Company granted BeiGene an exclusive license to develop, manufacture and commercialize sitravatinib in Asia (excluding Japan and certain other countries).

Research and development expenses for the first quarter of 2018 were $19.7 million, compared to $14.4 million for the same period in 2017. The increase in research and development expenses is primarily due to an increase in third party research and development expense for sitravatinib due to the continuation and expansion of ongoing clinical trials. The increase is also related to continued development of our KRAS inhibitor program for costs associated with preparing to file a planned IND application for our selected lead clinical compound, MRTX849. These increases are partially offset by a decrease in glesatinib expenses.

General and administrative expenses for the first quarter of 2018 were $5.2 million, compared to $3.7 million for the same period in 2017. The increase is primarily due to an increase in share-based compensation expense due to an increase in the fair value of stock options granted during the three months ended March 31, 2018 compared to the same period in 2017.

Net loss for the first quarter of 2018 was $14.7 million, or $0.51 per share basic and diluted, compared to net loss of $17.8 million, or $0.73 per share basic and diluted for the same period in 2017.

Cellular Biomedicine Group has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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