On November 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 September 30, 2018 (Press release, MacroGenics, NOV 7, 2018, View Source [SID1234531176]).

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"During the third quarter, MacroGenics made tremendous progress in advancing its portfolio of immuno-oncology product candidates towards multiple near-term data read-outs," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Given the Company’s substantial pipeline progress over the past several months, we believe that the next twelve months are poised to be transformative for MacroGenics, during which we expect to continue to advance our core mission of developing breakthrough biologics that may become life-changing medicines for patients."

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:
• Fully Enrolled Phase 3 Metastatic Breast Cancer Study. The Company has completed enrollment of 530 relapsed/refractory HER2-positive metastatic breast cancer patients in its pivotal SOPHIA study. MacroGenics anticipates disclosure of topline PFS data in the first quarter of 2019. In anticipation of a potential future product launch, MacroGenics is progressing its U.S. commercial planning and actively exploring ex-U.S. development and commercialization partnership opportunities.
• Phase 2 Gastric Cancer Study Demonstrated Antitumor Activity. At the 2018 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October, MacroGenics presented updated interim clinical data from a Phase 2 study of margetuximab plus an anti-PD-1 agent in patients with HER2-positive gastroesophageal adenocarcinoma. This chemotherapy-free combination, designed to coordinately engage innate and adaptive immunity, demonstrated antitumor activity in patients with advanced gastric cancer. The Company recently completed enrollment of 25 additional gastric cancer patients and expects to present data from this ongoing portion of the study in the first quarter of 2019.

PD-1 Franchise. MacroGenics is advancing multiple PD-1-directed programs to provide further differentiation from existing PD-1-based treatment options and enable a broad set of combination opportunities across the Company’s portfolio. Recent program highlights include:

Exhibit 99.1
• MGA012 Achieves Development Milestones. This anti-PD-1 mAb, also known as INCMGA0012, was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. MacroGenics retains the rights to develop MGA012 in combination with its pipeline assets. MGA012 met certain clinical proof-of-concept criteria, triggering a total of $15 million in milestones from Incyte, $10 million of which has been recognized in the third quarter and $5 million of which is expected to be recognized in the fourth quarter. Incyte plans to present updated data from the cohort expansion portion of the Phase 1 study of MGA012 in a poster session at the upcoming Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Incyte has announced its intention to pursue monotherapy development of MGA012 in MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer through registration-directed studies with initial data anticipated in 2020. In addition, across both Incyte and MacroGenics, multiple studies have been initiated which will feature various combination regimens with MGA012.
• MGD013 Dose Expansion Initiated. This first-in-class DART molecule provides 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. MacroGenics recently established the dose and schedule for MGD013 administration and has initiated dose expansion in up to nine tumor types in a Phase 1 study.
• MGD019 IND Cleared. This DART molecule is designed to provide co-blockade of both PD-1 and CTLA-4, two immune checkpoint inhibitors, on T cells. MacroGenics’ Investigational New Drug (IND) application for MGD019 was cleared by the FDA and the Company is currently engaged in Phase 1 study startup.
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. Recent program highlights include:
• Enoblituzumab Oral Presentation at SITC (Free SITC Whitepaper): Clinical data from MacroGenics’ study of this Fc-optimized mAb that targets B7-H3 combined with an anti-PD-1 mAb was selected for oral presentation at the upcoming SITC (Free SITC Whitepaper) Annual Meeting. Like the combination of margetuximab and anti-PD-1, enoblituzumab and anti-PD-1 is designed to leverage Fc-optimization and checkpoint blockade to coordinately engage innate and adaptive immunity, the two major components of the immune response. As an update of the recently released abstract, the combination of enoblituzumab and anti-PD-1 demonstrated antitumor activity in checkpoint inhibitor-naïve patients who had squamous cell carcinoma of the head and neck (SCCHN) and in checkpoint inhibitor-naïve patients with non-small cell lung cancer (NSCLC) with tumor PD-L1 expression of <1%. In these two cohorts, objective responses occurred in 6/18 (33%) response-evaluable SCCHN patients and in 5/14 (36%) response-evaluable NSCLC patients. Additional details will be provided at SITC (Free SITC Whitepaper).
• Orlotamab Studies Ongoing: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 monotherapy study in multiple tumor types. In addition, a combination study of orlotamab and MGA012 is ongoing.
• MGC018 Phase 1 Startup Initiated: MacroGenics’ IND submission for this anti-B7-H3 antibody-drug conjugate (ADC) was cleared by the FDA and the Company is initiating a Phase 1 study. This first-in-man study is designed to study MGC018 both as monotherapy and in combination with MGA012 in patients with solid tumors.
Flotetuzumab. Recent highlights of the Company’s bispecific, humanized DART molecule that recognizes both CD123 and CD3, include:
• Oral Presentations at ASH (Free ASH Whitepaper). MacroGenics plans to present both updated clinical data as well as gene signature data from its completed acute myeloid leukemia (AML) dose expansion cohort in two oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting next month. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Korea and India for flotetuzumab, also known as S80880.

Exhibit 99.1
• Combination Study with MGA012 Planned. MacroGenics has previously presented data supporting the rationale for using checkpoint blockade as an approach to potentially enhance the anti-leukemic activity of flotetuzumab and plans to commence a combination study with MGA012.

Third Quarter 2018 Financial Results
• Cash Position: Cash, cash equivalents and marketable securities as of September 30, 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 $20.8 million for the quarter ended September 30, 2018, compared to $1.7 million for the quarter ended September 30, 2017. This increase was primarily due to revenue recognized under the Incyte MGA012 collaboration. 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 $46.2 million for the quarter ended September 30, 2018, compared to $41.0 million for the quarter ended September 30, 2017. This increase was primarily due to the initiation of combination studies of MGA012, continued enrollment in multiple ongoing studies, increased development/manufacturing costs related to MGA012, which were partially reimbursed by Incyte, and increased headcount to support expanded manufacturing and development activities.
• G&A Expenses: General and administrative expenses were $9.6 million for the quarter ended September 30, 2018, compared to $8.4 million for the quarter ended September 30, 2017. This increase was primarily due to increased patent-related expenses and consulting and other costs incurred related to the implementation of the Company’s new enterprise resource planning (ERP) system.
• Net Loss: Net loss was $34.0 million for the quarter ended September 30, 2018, compared to net loss of $47.0 million for the quarter ended September 30, 2017.
• Shares Outstanding: Shares outstanding as of September 30, 2018 were 42,248,075.

Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended September 30, 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: 6548008.

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 November 7, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported financial results for the third quarter ended Sept. 30, 2018 and provided an operational update (Press release, Endocyte, NOV 7, 2018, View Source [SID1234530913]).

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"177Lu-PSMA-617’s value as a potential treatment for patients with mCRPC has been reinforced in both our regulatory interactions and our entry into a merger agreement with Novartis AG, along with our longstanding interactions with patients and physicians in the prostate cancer community," said Mike Sherman, president and CEO of Endocyte. "The team at Endocyte has always been passionate about developing innovative therapies to help change the treatment landscape for cancer patients, and we look forward to being able to leverage Novartis’ global expertise and commitment to help realize this mission."

Third Quarter and Recent Highlights

Announced on October 18, 2018, our entry into an agreement and plan of merger with Novartis AG (Novartis), subject to the terms and conditions of which Novartis will acquire Endocyte for $24 per share, or a total equity value of approximately $2.1 billion, in cash. The merger price represents a premium of 54% to Endocyte’s closing price of $15.56 on October 17, 2018.
Announced FDA acceptance of radiographic progression free survival (rPFS) as an alternative primary endpoint of the ongoing phase 3 VISION trial to support the submission of a New Drug Application (NDA) for full approval of 177Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
Completed an underwritten registered public offering of 10,878,379 shares of its common stock, including full exercise of the underwriters’ option to purchase additional shares of common stock, raising aggregate net proceeds from the offering of $188.9 million.
Presented pre-clinical data from the company’s chimeric antigen receptor T-cell (CAR T) adaptor molecule (CAM) platform at CAR-TCR Summit 2018.
Expected Upcoming Milestones

Submission of an Investigational New Drug (IND) application for a phase 1 trial of EC17/CAR T-cell therapy in patients with osteosarcoma (4Q 2018).
Completion of the proposed transaction between Endocyte and Novartis expected in 1H 2019, subject to approval by Endocyte stockholders, antitrust and regulatory approvals, and other customary closing conditions.
Analysis of rPFS in VISION trial (late 2019).
Third Quarter 2018 Financial Results

Endocyte reported a net loss of $12.6 million, or $0.17 per basic and diluted share, for the third quarter of 2018, compared to a net loss of $23.3 million, or $0.55 per basic and diluted share, for the same period in 2017.

Research and development expenses were $8.9 million for the third quarter of 2018, compared to $4.1 million for the same period in 2017. The increase was primarily attributable to: an increase of $4.5 million in expenses related to development of PSMA-617, including expenses related to the phase 3 VISION trial; an increase of $1.2 million in compensation expense, of which $0.4 million related to stock-based compensation charges; and an increase of $0.1 million related to the company’s EC17/CAR T-cell therapy program. These increases were partially offset by a decrease of $0.8 million in EC1169 trial expenses and a decrease of $0.2 million for general research.

General and administrative expenses were $4.8 million for the third quarter of 2018, compared to $3.0 million for the same period in 2017. The increase was primarily attributable to: an increase of $0.8 million in compensation expense, of which $0.5 million related to stock-based compensation charges; an increase of $0.6 million in legal and professional fees; and an increase of $0.4 million in other general and administrative fees.

In September 2017, the company recorded $16.5 million of acquired in-process research and development ("IPR&D") expenses related to a development and license agreement with ABX GmbH that granted the company exclusive worldwide rights to develop and commercialize PSMA-617, including the product candidate known as 177Lu-PSMA-617. The company did not incur any IPR&D expenses in the third quarter of 2018.

Cash, cash equivalents and investments were $344.2 million at September 30, 2018, compared to $103.1 million at September 30, 2017, and $97.5 million at Dec. 31, 2017. Cash, cash equivalents and investments of $344.2 million at September 30, 2018 included $188.9 million of net proceeds from the public offering of 10,878,379 shares of the company’s common stock that closed in September 2018.

Financial Expectations

The company anticipates its cash, cash equivalents and investments balance at the end of 2018 to exceed $310 million. Based on current operational assumptions, Endocyte believes it has sufficient cash to fund its activities through the expected end of the VISION trial and potential proof of concept of its EC17/CAR T-cell therapy.

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

On November 7, 2018 Synlogic, Inc. (Nasdaq: SYBX), reported that the Company will release its third quarter 2018 financial results after the market closes on Tuesday, November 13, 2018 (Press release, Synlogic, NOV 7, 2018, View Source [SID1234530949]). The press release will be followed by a conference call at 5:00 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

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The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 2674209. Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section

On November 7, 2018 Exicure, Inc. (OTCQB:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional spherical nucleic acid (SNA) constructs, reported plans to attend two investor conferences and two scientific conferences in November 2018 (Press release, Exicure, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2375799 [SID1234530970]).

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Exicure will be providing a corporate update November 13th, from 3:30 to 4:10 EST at the Stifel Healthcare Conference at the Lotte New York Palace, New York City. A live audio webcast will be available on the Events & Presentations section of Exicure’s website: www.exicuretx.com. A replay will be available for approximately 30 days. The company will also be attending the Jefferies London Healthcare Conference, November 14-15 at the Waldorf Hilton, London.

On November 9th and 10th the company will be presenting at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference at the Walter E. Washington Convention Center; Washington, D.C. Additionally, the company will be presenting at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Molecular Targets and Cancer Therapeutics Symposium November 13-16 at The Convention Centre Dublin; Dublin, Ireland

On November 7, 2018 Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT) reported that the FDA approved its IND to conduct a Phase 1b/2 trial of the safety and therapeutic benefit of Lixte’s lead clinical compound, LB-100, in patients with low and intermediate-1 risk myelodysplastic syndrome (MDS) who have failed or are intolerant of standard treatment. The study will be conducted at Moffitt Cancer Center, Tampa, FL (Press release, Lixte Biotechnology, NOV 7, 2018, View Source [SID1234530996]).

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Dr. John S. Kovach, founder and CEO of Lixte, said, "We are very pleased to receive approval to proceed with a study of the potential benefit of our lead protein phosphatase 2A inhibitor, LB-100, in the treatment of refractory MDS to be conducted by the team at Moffitt, long-time leaders in this field. Low and intermediate-1 risk MDS are often characterized by failure to produce normal amounts of red blood cells, so that patients with this syndrome require frequent blood transfusions. Reduction in the number of transfusions needed by these patients is one major goal of therapy, and provides a readily assessable parameter of therapeutic benefit within a few months of initiating treatment. At present, there is only one drug, Revlimid (Celgene), approved for one subtype of MDS."