On February 27, 2018 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported a corporate update and financial results for the fourth quarter and full year ending December 31, 2017 (Press release, Five Prime Therapeutics, FEB 27, 2018, View Source [SID1234524230]).

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"2017 was a year of continued progress across our pipeline," said Aron Knickerbocker, chief executive officer of Five Prime Therapeutics. "Notably, positive and important data in microsatellite stable pancreatic cancer are driving further development of the cabiralizumab/Opdivo combination in this cancer type, which is associated with tremendous unmet need, and in which no response to immunotherapy has been demonstrated. We also presented data in 2017 showing clinical benefit with cabiralizumab in patients with PVNS, and with bemarituzumab in patients with gastric cancer. In 2018, our clinical pipeline is on track to more than double to five products, and we will initiate our first global registrational clinical trial. Our unique discovery platform is proving to be an IND engine, and more programs are forthcoming. Additionally, our strategic alliances and strong balance sheet position us well to further advance our multiple assets."

2017 Business Highlights and Recent Developments

Clinical Pipeline:

Cabiralizumab (FPA008): an antibody that inhibits CSF1R and has been shown to block the activation and survival of monocytes and macrophages.

• Completed enrollment of the ongoing Phase 1a/1b trial of cabiralizumab/Opdivo (nivolumab) and Five Prime continues to treat patients who remain in the study.

- Five Prime completed enrollment in the trial, including patients with pancreatic cancer who were added to the trial after encouraging data were observed in the initial Phase 1b cohort of 31 patients with late-line pancreatic cancer.

- Five Prime and Bristol-Myers Squibb Company (BMS) are evaluating the safety, tolerability and preliminary efficacy of the immunotherapy combination of cabiralizumab with the PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in advanced solid tumors, including non-small cell lung cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, glioblastoma, renal cell carcinoma and ovarian cancer.

• BMS initiated randomized Phase 2 clinical trial in patients with locally advanced or metastatic pancreatic cancer.

- In January 2018, BMS initiated a randomized Phase 2 clinical trial (NCT03336216), evaluating cabiralizumab and Opdivo (nivolumab) with and without chemotherapy compared to chemotherapy alone in patients with advanced pancreatic cancer. The Phase 2 trial is expected to enroll approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy.

- The advancement of the cabira/ Opdivo (nivolumab) combination into Phase 2 development triggered a $25 million payment to Five Prime.

- Five Prime and others have previously demonstrated evidence of synergy by combining CSF-1R and PD-1 antibodies with chemotherapy in preclinical models of pancreatic cancer.

• Presented initial Phase 1a/1b data demonstrating early efficacy signal in heavily pre-treated patients with advanced pancreatic cancer with microsatellite stable (MSS) disease.

- In November 2017, Five Prime and BMS presented initial clinical safety data from all cohorts in the Phase 1a/1b clinical trial of cabiralizumab and Opdivo (nivolumab), and efficacy data from the Phase 1b pancreatic cancer cohort. In this Phase 1b cohort of heavily pre-treated patients with advanced pancreatic cancer (n=31 evaluable patients), durable clinical benefit was observed in five patients (16%), including confirmed objective responses in four patients with microsatellite stable (MSS) disease (objective response rate of 13%, confirmed by blinded independent review committee), a patient population in which no prior responses to immunotherapy have been demonstrated.

- Preliminary results show that the safety profile of cabiralizumab plus Opdivo (nivolumab) was generally consistent with that of monotherapy of the two drugs.

• Advanced the ongoing Phase 1/2 trial of cabiralizumab in patients with pigmented villonodular synovitis (PVNS).

- Five Prime reported initial trial data at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2017, showing that cabiralizumab demonstrated clinical benefit in patients with PVNS.

- The company is enrolling up to 30 additional patients in the Phase 2 portion of the trial to refine the dosing schedule to optimize the therapeutic index of cabiralizumab in this chronic disease setting. Data from these additional patients are intended to enable a go/no go decision by the end of 2018 on whether to advance cabiralizumab in PVNS into a pivotal trial.

- Five Prime estimates the combined prevalence of diffuse PVNS is approximately 67,500 patients in the U.S., EU5 and Japan.

Bemarituzumab (FPA144): an isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immuno-therapy for tumors that overexpress FGFR2b.

• Initiated Phase 1 portion (NCT03343301) of the FGFR2b Inhibition in Gastric Cancer Treatment (FIGHT) Phase 1/3 clinical trial, a global registrational study.

- The FIGHT trial will evaluate bemarituzumab in combination with the modified FOLFOX6 regimen (mFOLFOX6) versus placebo plus mFOLFOX6 in approximately 550 patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b or have FGFR2 gene amplification.

- In January 2018, Five Prime initiated patient dosing in the Phase 1 portion of the FIGHT trial. This safety lead-in portion of the study is designed to identify a recommended dose of bemarituzumab and to support the Phase 3 portion of the trial.

- The Phase 3 portion of the FIGHT trial is expected to begin in 2018 and will include sites in the U.S., Europe and Asia, including China, South Korea and Japan, where the incidence of gastric cancer is high.

- Five Prime will use immunohistochemistry (IHC) and circulating tumor DNA (ctDNA) tests to identify the estimated 10% of patients with gastric cancer who would be eligible for the trial.

• Entered into strategic development collaboration and exclusive license agreement in Greater China for bemarituzumab with Zai Lab in December 2017. Five Prime’s collaboration with Zai Lab will increase the speed of the FIGHT trial and lower Five Prime’s global development costs for the FIGHT trial. Five Prime earned a $5 million upfront payment and is eligible to receive up to $39 million in development and regulatory milestone payments. Five Prime is also eligible to receive from Zai Lab a royalty percentage on net sales of bemarituzumab in Greater China ranging from the high teens to the low twenties.

• In December 2017, Five Prime filed a clinical trial application (CTA) for bemarituzumab in China. With its collaborators at Zai Lab, Five Prime is aiming to initiate clinical trial sites in China for the FIGHT trial by the end of 2018.

• Enrolling patients in Phase 1 safety trial of bemarituzumab monotherapy in unselected patients with gastric cancer in Japan, where the incidence of gastric cancer is high. Completion of this Phase 1 trial is intended to enable the inclusion of Japanese patients in the Phase 3 portion of the FIGHT trial.

• Advanced the Phase 1 monotherapy cohort testing bemarituzumab in patients with metastatic bladder cancer. The company continues to enroll patients in the Phase 1 clinical trial cohort testing bemarituzumab as a treatment for patients with metastatic bladder cancer whose tumors overexpress FGFR2b.

FPA150 (anti-B7-H4): An antibody designed for two mechanisms of action: to block an inhibitory T cell checkpoint pathway and to enhance killing of B7-H4-expressing tumors by ADCC. B7-H4 is frequently overexpressed in breast, ovarian, endometrial and bladder cancers.

• Investigational New Drug (IND) application submitted December 2017.

- Five Prime anticipates initiating the Phase 1 trial in the first half of 2018.

• Data featured in an oral poster discussion during the ESMO (Free ESMO Whitepaper) 2017 Congress.

- Data presented suggest that FPA150, which possesses T cell checkpoint and ADCC activity, has the potential to be an effective therapeutic by improving anti-tumor immune responses in patients with cancer.

BMS TIM-3 Antibody: Achieved a $5 million milestone payment for the first IND filing by BMS for a therapeutic candidate under the immuno-oncology research collaboration with Five Prime.

• In January 2018, BMS filed an IND for the first clinical candidate from the immuno-oncology research collaboration with Five Prime. The candidate is a fully-human monoclonal antibody targeting TIM-3 (T-cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that is known to limit the duration and magnitude of T-cell responses.

• In December 2017, BMS extended the research term an additional year to March 2019. This is the second extension to the original research term under the agreement that was established in March 2014.

Preclinical Research and Development:

FPT155 (CD80-Fc): A CD80 fusion protein that uses the binding interactions of soluble CD80 to (i) block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment and (ii) directly engage CD28 to further enhance its co-stimulatory T-cell activation activity without inducing super agonism.

• Preclinical data on FPT155 were featured in a poster presentation at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October. Work done in preclinical models with FPT155 suggests that it has the potential to be a potent T-cell co-stimulator with strong monotherapy antitumor activity, and it may have a synergistic effect when combined with anti-PD1 therapy.

• Five Prime anticipates filing an IND application or a foreign equivalent in mid-2018.

Target discovered by Five Prime in its respiratory disease collaboration exclusively licensed by partner GSK.

• In August 2017, GSK exercised its right to license exclusively a drug target discovered by Five Prime in the respiratory disease collaboration between the companies. This resulted in a $500,000 payment to Five Prime.

• This is the second respiratory target that GSK exclusively licensed from Five Prime under the respiratory disease collaboration.

Summary of Financial Results and Guidance:

• Cash Position. Cash, cash equivalents and marketable securities totaled $292.7 million on December 31, 2017 compared to $421.7 million on December 31, 2016. The decrease in year-end cash in 2017 was primarily attributable to net cash used in operations to advance the company’s clinical and preclinical pipeline. On January 29, 2018, Five Prime completed a public offering resulting in estimated net proceeds of approximately $108 million.

• Revenue. Collaboration and license revenue for the fourth quarter of 2017 increased by $4.9 million, or 59%, to $13.2 million from $8.3 million for the fourth quarter of 2016. Five Prime earned a $5 million milestone payment from BMS in the fourth quarter of 2017 for the first IND application by BMS for a therapeutic candidate under the immune checkpoint pathway discovery collaboration. Collaboration and license revenue for the full year 2017 increased by $8.8 million, or 29%, to $39.5 million from $30.7 million for the full year 2016. This difference was primarily from increases in revenue from the cabiralizumab collaboration agreement with BMS and the immune checkpoint pathway discovery collaboration with BMS.

•

R&D Expenses. Research and development expenses for the fourth quarter of 2017 increased by $3.6 million, or 12%, to $32.7 million from $29.1 million in the

fourth quarter of 2016. Full year 2017 research and development expenses increased by $56.8 million, or 60%, to $150.9 million from $94.1 million in 2016. These increases were primarily related to advancing the bemarituzumab program in a Phase 1 clinical trial, advancing the cabiralizumab program in immuno-oncology and PVNS, advancing the FPA150 program to an IND application, and advancing our internal immuno-oncology preclinical and research activities.

• G&A Expenses. General and administrative expenses for both the fourth quarters of 2017 and 2016 was $10.5 million. Full year 2017 general and administrative expenses were $40.0 million, an increase of $4.2 million, or 12%, from $35.8 million in 2016. This increase was primarily due to greater facilities expenses related to our new corporate office and personnel related expenses, including stock-based compensation.

• Net Income (Loss). Net loss for the fourth quarter of 2017 was $29.2 million, or $1.04 per basic share and diluted share, compared to a net loss of $20.1 million, or $0.73 per basic and diluted share, for the fourth quarter of 2016. Full year 2017 net loss was $150.2 million, or $5.38 per basic share and diluted share, compared to a net loss of $65.7 million, or $2.44 per basic share and diluted share for the full year 2016. These increases in net loss were primarily related to advancing the clinical pipeline and preclinical research and development.

Cash Guidance. Five Prime expects full-year 2018 net cash used in operating activities to be less than $135 million, which includes the previously mentioned milestone payments earned by Five Prime. The company estimates ending 2018 with approximately $250 million in cash, cash equivalents and marketable securities.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 7184787. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On February 27, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that it will host a conference call and webcast to provide an update on development plans for GMI-1271 in acute myeloid leukemia (AML) as well as to report its fourth quarter and fiscal year 2017 financial results on Tuesday, March 6, 2018, at 8:30 a.m. ET (Press release, GlycoMimetics, FEB 27, 2018, View Source [SID1234524233]).

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The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 1453008. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, participant code 1453008.

About GMI-1271

GlycoMimetics plans to initiate in mid-2018 a Phase 3 clinical trial evaluating GMI-1271 in relapsed/refractory AML patients. In the recently completed Phase 1/2 clinical trial, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, as well as lower than expected induction-related mortality rates. Importantly, treatment in this patient population was well tolerated with minimal adverse effects. The candidate drug is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.

On February 27, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies reported that it will be presenting at the Cowen & Company 38th Annual Healthcare Conference in Boston on Tuesday, March 13 at 9:20 a.m. ET/6:20 a.m. PT (Press release, Halozyme, FEB 27, 2018, View Source [SID1234524234]). Laurie Stelzer, senior vice president and chief financial officer, will provide a company overview.

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A webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following the event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

On February 27, 2018 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and twelve months ended December 31, 2017 and highlighted recent corporate progress (Press release, Heron Therapeutics, FEB 27, 2018, View Source [SID1234524237]).

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Recent Corporate Progress

CINV Franchise

SUSTOL Sales. Net product sales of SUSTOL (granisetron) extended-release injection for the three months ended December 31, 2017 were $10.1 million, up 17% from the net product sales for the three months ended September 30, 2017 of $8.6 million. SUSTOL net product sales for the twelve months ended December 31, 2017 were $30.8 million, versus guidance of $25 million to $30 million.
2018 CINV Sales Guidance. Net product sales guidance for full-year 2018 for the CINV franchise is $60 million to $70 million.
Permanent J-Code Now Effective. On January 1, 2018,a product-specific billing code, or permanent J-code, for SUSTOL became available. The new J-code was assigned by the Centers for Medicare and Medicaid Services (CMS) and will help simplify the billing and reimbursement process for prescribers of SUSTOL.
CINVANTI Now Available. In November 2017, the U.S. Food and Drug Administration (FDA) approved the Company’s New Drug Application (NDA) for CINVANTI (aprepitant) injectable emulsion, the first and only polysorbate 80-free intravenous (IV) formulation of a neurokinin-1 (NK1) receptor antagonist indicated for the prevention of acute and delayed CINV. CINVANTI became commercially available in the United States on January 4, 2018.

Pain Management Franchise

Enrollment Complete in Phase 3 Pivotal Trials for HTX-011 in Postoperative Pain. Heron completed enrollment in its two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair. Heron anticipates reporting top-line results in the first half of 2018 and expects to file an NDA with the FDA in the second half of 2018.

"2017 was an excellent year for Heron, with significant progress in both our CINV and pain management franchises," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "2018 should be an equally exciting year as we look forward to reporting top-line pivotal Phase 3 data and filing an NDA for HTX-011, while continuing to ramp up net product sales for our CINV franchise."

Financial Results

Net product sales of SUSTOL for the three and twelve months ended December 31, 2017 were $10.1 million and $30.8 million, respectively. Heron commenced commercial sales of SUSTOL in October 2016. Net product sales of SUSTOL for both the three and twelve months ended December 31, 2016 were $1.3 million.

Heron’s net loss for the three and twelve months ended December 31, 2017 was $62.5 million and $197.5 million, or $1.09 per share and $3.65 per share, respectively, compared to a net loss of $48.0 million and $173.1 million, or $1.22 per share and $4.56 per share, respectively, for the same periods in 2016. Net loss for the three and twelve months ended December 31, 2017 included non-cash, stock-based compensation expense of $6.9 million and $30.5 million, respectively, compared to $7.3 million and $26.0 million, respectively, for the same periods in 2016.

As of December 31, 2017, Heron had $172.4 million in cash, cash equivalents and short-term investments, which included net proceeds of $142.6 million from an underwritten public offering of common stock completed in December 2017. Net cash used for operating activities for the three and twelve months ended December 31, 2017 was $47.1 million and $170.3 million, respectively, compared to net cash used for operating activities of $38.5 million and $134.1 million, respectively, for the same periods in 2016.

About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. The Phase 2 development program for HTX-011 was designed to target the many patients undergoing a wide range of surgeries who experience significant postoperative pain. Heron completed enrollment in its two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair and anticipates reporting top-line results in the first half of 2018 and expects to file an NDA with the FDA in the second half of 2018.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI is indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist. CINVANTI is the first intravenous (IV) formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 receptor antagonist to significantly reduce CINV in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). CINVANTI does not contain polysorbate 80 or any other synthetic surfactant. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain. FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion.

Please see Full Prescribing Information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).

On February 27, 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 a corporate progress update and financial results for the year ended December 31, 2017 (Press release, MacroGenics, FEB 27, 2018, View Source [SID1234524243]).

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"We have had multiple advances in our portfolio of product candidates recently," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "In addition to margetuximab passing an interim futility analysis for the SOPHIA Phase 3 metastatic breast cancer study, a combination of margetuximab with an anti-PD-1 agent has shown encouraging activity in the treatment of gastric cancer patients in a Phase 2 study. Furthermore, we continue to enroll relapsed/refractory acute myeloid leukemia (AML) patients in the flotetuzumab dose expansion study following the promising results that were presented at recent medical conferences. As we continue to advance these and our other candidates, we look forward to presenting additional data in 2018 and defining future development strategies across our portfolio."

Key Pipeline Updates

Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody 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 by the end of 2018.
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, a 32% objective response rate and median progression-free survival of 5.5 months in a subpopulation of 25 patients with gastric cancer. Based on these results, MacroGenics is expanding the study by enrolling 25 additional gastric cancer patients and will continue to evaluate biomarkers to determine the patients who are most likely to benefit from margetuximab plus anti-PD-1 therapy.

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

Monotherapy Study. Updated data from an ongoing dose expansion study of flotetuzumab in patients with AML and myelodysplastic syndrome (MDS) were presented at the Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting in December 2017. Consistent with previously disclosed earlier dose escalation data, flotetuzumab demonstrated acceptable tolerability as well as evidence of anti-leukemic activity. MacroGenics continues to enroll the AML and MDS dose-expansion cohorts and anticipates presenting updated clinical data in 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 anti-PD-1. At the Annual ASH (Free ASH Whitepaper) Meeting in December 2017, MacroGenics 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 MGA012, an anti-PD-1 monoclonal antibody (mAb), by mid-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:

MGA012. MGA012 is a humanized, proprietary anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. MGA012 was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. Patients are being enrolled across multiple dose expansion cohorts in a Phase 1 study.
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 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 Investigational New Drug (IND)-enabling studies and anticipates submitting the IND application for MGD019 in 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 continues to recruit patients with various solid tumors in an ongoing study of this Fc-optimized monoclonal antibody that targets B7-H3, in combination with an anti-PD-1 mAb. The Company expects to present clinical data from this study in 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 2018. In addition, a combination study of MGD009 and MGA012 was recently initiated.
MGC018: The Company is completing IND-enabling activities to support submission of an IND application for this anti-B7-H3 antibody drug conjugate (ADC) in 2018.

Additional DART Clinical Programs. Additional DART molecules in Phase 1 clinical development being led by MacroGenics include the following:

MGD007. The Company is completing a monotherapy study of MGD007, a DART molecule that recognizes gpA33 and CD3, and anticipates commencing a combination study with MGA012 in 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 in 2018.

Corporate Update

Incyte Collaboration. In October 2017, MacroGenics announced that it had entered into a global collaboration and license agreement with Incyte. The Company received an upfront payment of $150 million upon closing in December 2017 and is eligible to receive milestones and royalties on any future sales of MGA012. MacroGenics retains the right to develop its own pipeline assets in combination with MGA012, with Incyte commercializing MGA012 and MacroGenics commercializing its combinatorial asset(s), if any such potential combinations are approved. In addition, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012.
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 began the expansion of its manufacturing capacity in early 2017 by commencing the build-out of a GMP suite in its headquarters building in Rockville, Maryland to support larger-scale clinical and commercial manufacturing. MacroGenics expects this manufacturing suite to be fully operational in 2018.
Dr. Jay Siegel Added to Board. In November 2017, MacroGenics announced the appointment of Jay Siegel, M.D., former Chief Biotechnology Officer and Head of Scientific Strategy and Policy at Johnson & Johnson, to its Board of Directors.

2017 Financial Results and Cash Runway Guidance

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2017, were $305.1 million, compared to $285.0 million as of December 31, 2016.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $157.7 million for the year ended December 31, 2017, compared to $91.9 million for the year ended December 31, 2016. 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 $147.2 million for the year ended December 31, 2017, compared to $122.1 million for the year ended December 31, 2016. This increase was primarily due to continued or expanded enrollment across multiple clinical trials as well as IND-enabling activities related to two preclinical product candidates.
G&A Expenses: General and administrative expenses were $32.7 million for the year ended December 31, 2017, compared to $29.8 million for the year ended December 31, 2016. This increase was primarily due to labor-related costs, including stock-based compensation expense, and information technology-related expenses, partially offset by lower patent expenses.
Net Loss: Net loss was $19.6 million for the year ended December 31, 2017, compared to net loss of $58.5 million for the year ended December 31, 2016.
Shares Outstanding: Shares outstanding as of December 31, 2017 were 36,859,077.
Cash Runway Guidance: MacroGenics expects that its current cash, cash equivalents and marketable securities, combined with anticipated funding under its current strategic collaborations, should fund the Company’s operations for approximately two years.