On November 14, 2017 Molecular Templates, Inc. (Nasdaq:MTEM), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported financial results for the third quarter of 2017 (Press release, Molecular Templates, NOV 14, 2017, View Source [SID1234522067]). As of September 30, 2017, cash and cash equivalents totaled $68.2 million.

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"The completion of our merger with Threshold Pharmaceuticals as well as the $60M in financings in the third quarter mark a significant milestone for Molecular Templates," said Molecular Templates’ Chief Executive Officer and Chief Scientific Officer, Eric Poma, Ph.D. "The merger and financings put us in a strong position to continue to execute on the development of our lead program, MT-3724, in aggressive lymphomas as well as make strides toward the clinic in 2018 with our next generation of ETBs currently in preclinical development. Additionally, we are excited about our ongoing research collaboration with Takeda Pharmaceuticals as we look to expand the application of our ETB technology."

Company Highlights and Upcoming Milestones

Corporate
On August 1, 2017, we successfully completed the reverse merger with Threshold Pharmaceuticals, Inc. (previously Nasdaq ticker: THLD) and concurrently changed the Company’s name to Molecular Templates, Inc. (new Nasdaq ticker: MTEM).

On August 1, 2017, we closed an equity financing for $40 million; as well as a private placement of $20 million to Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd.

MT-3724
On October 24, 2017, we announced the identification of the maximum tolerated dose (MTD) for MT-3724 and the initiation of and first patient dosed in an expansion cohort, as part of the second portion of the ongoing Phase I study focused on relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients. The expansion cohort is expected to better define the overall response rate to MT-3724 in heavily pre-treated DLBCL patients. Initial results of this expansion cohort are expected to be announced in 1H18.

Molecular anticipates initiating a Phase II monotherapy study in relapsed and refractory DLBCL patients in 2018.
Takeda Collaboration

Expanded Takeda collaboration in June 2017 with Multi-Target Research and Licensing Collaboration Agreement to develop next-generation oncology therapies, including stock purchase.

MT-4019
Continued development of MT-4019, an ETB candidate that is designed to target CD38-expressing myeloma cancer cells.

Plan to submit an IND application to the FDA in mid-2018 to initiate a Phase I clinical trial in the United States.
Research

Several other ETB candidates in pre-clinical development targeting both solid and hematological cancers where the differentiated mechanism of action innate to ETBs, ribosome inactivation, could play a significant role in treating cancer.

Financial Results
The net loss attributable to common shareholders for the third quarter was $(11.1) million, or $(0.62) per basic and diluted share. This is compared to a net loss attributable to common shareholders for the same period in 2016, of $(3.6) million, or $(11.89) per basic and diluted share. As of September 30, 2017, cash and cash equivalents totaled $68.2 million, which includes $11.2 million received from the merger with Threshold Pharmaceuticals in August 2017 and the receipt of $60 million for two financings that closed on the same day.
Revenues for the third quarter of 2017 were $0.6 million, compared to no revenues during the same period in 2016. Revenues for the third quarter of 2017 related to research and development revenues from our collaboration with Takeda.

Total research and development (R&D) expenses for the third quarter of 2017 were $2.5 million, compared with $2.3 million for the same period in 2016. The $0.2 million increase in R&D expenses in the third quarter of 2017, compared with the same period in 2016, was primarily due to severance benefits related to the merger with Threshold.

Total general and administrative (G&A) expenses for the third quarter of 2017 were $4.0 million, compared with $0.8 million for the same period in 2016. The $3.2 million increase in G&A expenses in the third quarter of 2017, compared with the same period in 2016, was primarily due to costs associated with the Merger and being a publicly traded company.

Revenues for the nine months ended September 30, 2017 were $2.6 million, compared to $1.5 million for the same period in 2016. Revenues for the nine months ended September 30, 2017 were primarily comprised of research and development revenues from our collaboration with Takeda. Revenues for the same period in 2016 comprised of grant revenue from the Cancer Prevention & Research Institute of Texas ("CPRIT").

Total R&D expenses for the nine months ended September 30, 2017 were $4.8 million, compared to $7.2 million for the same period in 2016. The $2.4 million decrease in R&D expenses for the nine months ended September 30, 2017, compared the same period in 2016, was primarily due to decreased spending for outsourced preclinical costs.
Total G&A expenses for the nine months ended September 30, 2017 were $8.2 million, compared to $2.6 million for the same period in 2016. The $5.6 million increase in G&A spending for the nine months ended September 30, 2017, compared to the same period in 2016, was primarily due to costs associated with the Merger and being a publicly traded company.

The net loss attributable to common shareholders for the nine months ended September 30, 2017 was $(17.2) million, or $(2.75) per basic and diluted share, compared to a net loss attributable to common shareholders of $(9.6) million or $(32.01) per basic and diluted share, for the same period in 2016.

On November 14, 2017 Purdue Pharma L.P. reported completion of significant oncology related investments as part of its ongoing efforts to diversify its scientific research into areas of high unmet medical need (Press release, Purdue Pharma, NOV 14, 2017, View Source [SID1234527505]). Through these investments, executed over a multi-year period and capped recently in 2017, Purdue is establishing a portfolio of drug candidates with the potential to deliver new cancer therapies to patients within the next five years.

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"With this formal entry into oncology research and development, Purdue is evolving as a company and renewing its foundational commitment to bring important new medicines to patients and physicians who need them," said Craig Landau, president and CEO, Purdue Pharma. "We are excited by the opportunity and the potential to make meaningful contributions to the field of cancer medicine."

In assembling this portfolio, Purdue now has four drug candidates in development for multiple cancer types:

EDO-S7.1, a novel topoisomerase inhibitor, is designed to work by metabolizing into its active form through enzymes in the gastrointestinal tract that are particularly active in cancer cells. In an interim analysis of a phase 2 trial in patients with therapy refractory advanced biliary tract cancers, the trial met the primary endpoint of rate of disease control (DCR) after first stage. In the trial, commonly observed drug related adverse events were: myelosuppression (including grade 3-4 neutropenia and thrombocytopenia), infection, alopecia, fatigue, nausea, and abdominal pain.1
EDO-S101, also known as tinostamustine, is a novel, first-in-class alkylating deacetylase inhibitor (AK-DACi) compound currently advancing through phase 1 human trials. Preclinical studies suggest that tinostamustine delivers both alkylating activity and pan-histone deacetylase (HDAC) inhibition to simultaneously damage DNA and block damage repair in cancer cells. The development programs for this drug candidate are investigating its potential utility in both solid and hematologic tumors.
EDO-B776 and EDO-B278 are two late pre-clinical stage antibody-drug conjugates. EDO-B776 is being studied for its potential to target the cancer antigen 125 (CA-125) in ovarian cancer. EDO-B278 is an antibody-drug conjugate targeting the human tissue factor and is in development for various solid tumors.
Research on these drug candidates is being directed on behalf of Purdue by Mundipharma EDO GmbH, part of the Mundipharma network of independent associated companies.

"We are pleased to collaborate with Purdue Pharma on the development of these important compounds," said Dr. Thomas Mehrling, chief executive officer, EDO. "Purdue’s strong experience developing novel treatments will translate well to oncology and we are confident that this will be a successful partnership."

Purdue will also continue to selectively seek additional oncology product assets through licensing and acquisition, and the company will maintain a priority interest in candidates with mechanisms complementary to emerging immuno-oncology based treatment paradigms.

On November 14, 2017 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that the company will make a presentation at the following upcoming event (Press release, Arrowhead Research Corporation, NOV 14, 2017, View Source [SID1234522035]):

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29th Annual Piper Jaffray Healthcare Conference – New York, November 28-29, 2017

November 28, 9:30 a.m. EST – Christopher Anzalone Ph.D., Arrowhead president and chief executive officer will participate in a fireside chat presentation.

A webcast of the event may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

On November 14, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported the appointment of Eugene P. Kennedy, M.D., FACS, to the role of Chief Medical Officer. He will be responsible for leading all clinical development, medical affairs and related functions. Dr. Kennedy’s previous role at NewLink Genetics was Vice President of Clinical and Medical Affairs (Press release, NewLink Genetics, NOV 14, 2017, View Source [SID1234522068]).

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"Gene’s considerable experience in clinical trial design and implementation has made him an invaluable team member at NewLink," said Charles J. Link, Jr., MD, Chairman, Chief Executive Officer and Chief Scientific Officer. "We are glad he has taken on this new responsibility and know he will continue to contribute the critical expertise we need as we commence with enrollment of our pivotal trial for patients with advanced melanoma."

Dr. Kennedy joined NewLink in 2014 from Thomas Jefferson University in Philadelphia, PA where he served as Associate Professor of Surgery and held leadership positions as Chief of the Section of Pancreaticobiliary Surgery and Co-Director of the Jefferson Pancreas, Biliary, and Related Cancers Center. Previously, Dr. Kennedy has held faculty positions at the Johns Hopkins Hospital in Baltimore, MD and the Louisiana State University School of Medicine in New Orleans, LA. Dr. Kennedy obtained his undergraduate education at the University of Virginia and received his medical degree from the Medical College of Virginia. He completed a residency and fellowship in Surgery and Surgical Oncology as well as a research fellowship in tumor immunology at the Johns Hopkins Hospital.

On November 14, 2017 Tusk Therapeutics an immuno-oncology company with a focus on harnessing the power of the immune system to fight cancer through the development of novel immune modulating therapeutics, reported that it has been awarded a £2.5 million grant from Innovate UK (Press release, Tusk Therapeutics, NOV 14, 2017, View Source [SID1234522144]). The grant will be used to accelerate the development of its novel and strongly differentiated anti-CD38 monoclonal antibody as a cancer immunotherapy.
Tusk’s anti-CD38 antibody has the potential to significantly broaden the efficacious utility of monoclonal antibodies targeting the CD38 receptor, extending the current application beyond haematological tumours (e.g. Multiple Myeloma) to solid tumours. Tusk’s antibody’s novel mode of action aims to modulate the tumour microenvironment to allow the body’s immune system to generate a potent anti-tumour response.

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The grant will facilitate the completion of preclinical activities for its anti-CD38 antibody program and to conduct a Phase I trial and builds on Tusk’s preclinical research and recent novel insights into CD38 biology.

Luc Dochez, Chief Executive Officer of Tusk Therapeutics, commented: "We thank Innovate UK for supporting us with this grant which we believe is a great endorsement of the work currently being undertaken at Tusk. This grant will allow us to continue to accelerate the development of our novel CD38 programme. Tusk has established a growing, diversified pipeline of antibodies against a selection of both novel and validated targets that we believe have the potential to complement and improve upon current and emerging immune-oncology therapies. The UK is ideally placed as a hub for life science companies. Access to funding and support from industry bodies, such as Innovate UK, is invaluable for companies at our stage of development and is one of the reasons why Tusk, as a European company, has chosen to base itself in the UK."