On November 7, 2018 Inventiva reported that it will be presenting a poster on its YAP/TEAD pre-clinical program at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Therapeutics Symposium being held on November 13-16, 2018 in Dublin, Ireland (Press release, Inventiva Pharma, NOV 7, 2018, View Source [SID1234625407]).

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The poster to be presented, entitled "Discovery of promising anti-cancer drug combination using YAP-TEAD inhibitors with standard of care treatment in mesothelioma and NSCLC cells", illustrates some of the recent data observed by Inventiva in pre-clinical studies, which suggest that the YAP/TEAD inhibitor molecules being investigated by the Company may have potential as a therapy in the treatment of mesothelioma, Non-Small Cell Lung Cancer (NSCLC) and other cancers.

Inventiva’s YAP/TEAD approach aims at disrupting the formation of the transcriptional complex formed by YAP and TEAD, which are believed to be key players in the oncogenic process as well as in fibrogenesis.

Inventiva has observed that its lead YAP/TEAD inhibitor molecules have prevented the formation of the YAP/TEAD transcriptional complex in vitro and are associated with a reduction of YAP/TEAD target genes expression and anti-proliferative effects in cancer cell lines where proliferation is under the control of the Hippo pathway. The Company has also observed in xenograft and patient-derived xenograft (PDX) mice models that its YAP/TEAD inhibitor molecules exhibited activity both as a stand-alone treatment or in combination with standard of care.

Based on these promising results, the Company plans to finalize the toxicological studies necessary to advance its YAP/TEAD program into Phase I/II clinical development in 2019.

"We have made significant progress in our understanding of the Hippo pathway, which offers exciting potential for the treatment of rare and prevalent cancers," stated Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva. "We have observed that our patented small molecules exhibited activity both as a stand-alone treatment and in combination with standard of care in pre-clinical models. In addition, molecules that inhibit the YAP/TEAD interaction have already shown a potential to overcome drug resistance and tumor escape mechanisms, which makes this pathway particularly interesting. Our program is advancing well and we are looking forward to see it progressing into Investigational New Drug (IND) enabling studies."

The event details for the presentations are as follows:

Poster Title: "Discovery of promising anti-cancer drug combination using YAP-TEAD inhibitors with standard of care treatment in mesothelioma and NSCLC cells"
Session Title: Drug Resistance and Modifiers
Date: Tuesday, November 13th
Time: 10am to 2pm
Location: The Convention Centre, Spencer Dock, North Wall Quay, Dublin, Ireland

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."