On March 28, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported financial results for the fourth quarter ended December 31, 2017 and provided an update on recent clinical and corporate developments (Press release, Deciphera Pharmaceuticals, MAR 28, 2018, View Source [SID1234525037]).

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"2017 was a highly productive year for Deciphera marked by significant progress with our lead program, DCC-2618. Data presented throughout the year continue to support our belief that DCC-2618 has the potential to serve as a much-needed therapy across multiple disease indications where treatment options for patients are limited," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "We have entered 2018 with strong momentum, and we were pleased to announce the initiation of our pivotal Phase 3 INVICTUS study of DCC-2618 in fourth-line plus GIST, which, if successful, could serve as the basis for a New Drug Application (NDA). Pending regulatory feedback in the US and Europe, we expect to initiate an additional pivotal Phase 3 study in second-line GIST patients later this year, and we plan to report data emerging from our Phase 1 expansion study cohorts over the course of the year."

Dr. Taylor added, "Following our successful IPO last year, we have a strong balance sheet and believe we are well-positioned for continued success across our full clinical-stage pipeline, including DCC-3014 and rebastinib, and look forward to sharing our progress throughout the coming months."

Recent Clinical and Corporate Developments

DCC-2618
Announced the initiation of the Phase 3 INVICTUS pivotal study in January 2018 evaluating the safety and efficacy of DCC-2618, in heavily pretreated patients with advanced gastrointestinal stromal tumors (GIST). The Company expects to report top-line data from the study in 2019.
Received Orphan Drug Designation from the European Medicines Agency in November 2017 for the treatment of GIST.
Provided an enrollment update from the ongoing Phase 1 clinical trial of DCC-2618 at the Annual Meeting of The Connective Tissue Oncology Society in November 2017. As of October 31, 2017, a total of 125 patients had been dosed with DCC-2618 of which 109 were GIST patients, including 54 GIST patients in three expansion cohorts of the Phase 1 trial, which are enrolling second-line, third-line, and fourth-to-fifth line GIST patients, respectively.
Reported data on eight patients with malignant gliomas in the ongoing Phase 1 clinical trial of DCC-2618 at the 22nd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology in November 2017, including a 94% tumor reduction per RANO after 84 weeks (cycle 23, day 1) from a patient with glioblastoma multiforme (GBM) and amplification of three kinase genes, KIT, PDGFRα and VEGFR2.
Corporate Updates
Completed an initial public offering of 8,166,496 shares of its common stock in October 2017 at a public offering price of $17.00 per share, including shares pursuant to the partial exercise by the underwriters of their option to purchase additional shares. Deciphera Pharmaceuticals received net proceeds of approximately $124.6 million from the offering, after deducting underwriting discounts, commissions and offering expenses.
Fourth Quarter 2017 Financial Results

Cash Position: As of December 31, 2017, Deciphera Pharmaceuticals reported cash and cash equivalents of $196.8 million.

R&D Expenses: Research and development expenses for the fourth quarter of 2017 were $15.7 million compared to $6.5 million for the same period in 2016. The increase was primarily due to an increase in spending on the DCC-2618 program of $6.3 million as a result of clinical trial costs related to the Phase 1 trial as well as start-up activities related to the pivotal Phase 3 trial in fourth-line GIST, and increased manufacturing and preclinical study costs to support the current and planned clinical trials. In addition, facility and personnel related costs increased an aggregate of $2.9 million as the result of an increase in costs associated with early-stage drug discovery programs and headcount. Personnel costs for each of the fourth quarters of 2017 and 2016 included non-cash share-based compensation expense of $0.5 million and $0.2 million, respectively.

G&A Expenses: General and administrative expenses for the fourth quarter of 2017 were $4.7 million, compared to $2.0 million for the same period in 2016. The increase was primarily due to an increase in non-cash share-based compensation, which was $2.3 million and $0.4 million for each of the fourth quarters of 2017 and 2016, respectively. In addition, legal and professional fees increased as a result of ongoing business activities and operations as a public company.

Net Loss: For the fourth quarter of 2017, Deciphera reported a net loss of $19.9 million, or $0.62 per share, compared with a net loss of $8.6 million, or $0.74 per share, for the same period in 2016.

On March 28, 2018 Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing a T-cell immunotherapy product candidate designed to reduce Graft versus Host Disease (GVHD) in hematopoietic stem cell transplantations (HSCT), reported it will be announcing its 2017 Annual Results for the year ended December 31, 2017 at 7:00am CEST on Friday, April 13, 2018 (Press release, Kiadis, MAR 28, 2018, View Source [SID1234525133]). The Kiadis management will also be hosting an analyst and investor conference call at 2:00pm CEST / 8:00am EDT on Friday, April 13, 2018.

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For more information, please contact:

Kiadis Pharma:
Karl Hård, Head of IR & Communications
Tel. +31 (0) 611 096 298
[email protected] Optimum Strategic Communications:
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 (0) 203 714 1787
[email protected]

On March 28, 2018 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that it initiated patient dosing in its Phase 1 clinical trial of FPA150, a first-in-class immuno-oncology antibody that targets B7-H4 (Press release, Five Prime Therapeutics, MAR 28, 2018, View Source [SID1234525038]).

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"We’re excited to advance into the clinic our targeted, first-in-class B7-H4 antibody, FPA150, which offers a differentiated approach to existing immunotherapies," said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. "We’re studying FPA150 in patients whose tumors overexpress B7-H4 and in which there is high unmet need for immuno-oncology treatments, such as in breast, ovarian and endometrial cancer. We’re hopeful that a targeted therapy such as FPA150 may provide clinical benefit."

Five Prime designed the Phase 1 trial of monotherapy FPA150 with a dose-escalation phase in patients with solid tumors, followed by dose expansion in pre-specified cohorts in tumor types based on B7-H4 expression levels. The initial targeted tumors are advanced or metastatic breast, ovarian, endometrial and bladder cancers. Phase 1a dose escalation endpoints include identification of a maximum tolerated dose (MTD), safety, and pharmacokinetics (PK) of FPA150. Phase 1b dose expansion endpoints include objective response rate, as well as safety and PK.

About FPA150

FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 expression is observed in multiple solid tumors, including breast, bladder and gynecologic cancers, and has been documented to correlate with poor prognosis. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as delivering potent ADCC against tumor cells expressing B7-H4.

Osiris Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Osiris Therapeutics, 2018, MAR 28, 2018, View Source [SID1234525028]).

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On March 28, 2018 Molecular Templates, Inc. (Nasdaq:MTEM) ("Molecular"), 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 fourth quarter of 2017. As of December 31, 2017, cash and cash equivalents totaled $58.9 million (Press release, Molecular Templates, MAR 28, 2018, View Source [SID1234525039]). Molecular’s current cash balance is expected to fund operations into late 2019.

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"We are excited by the continued progress of our pipeline as well as our partnership with Takeda," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "We expect the remainder of 2018 to bring more data on our lead program MT-3724 in DLBCL, additional IND filings for other pipeline programs, and the potential for more business development transactions that would support additional programs with non-dilutive capital."

Company Highlights and Upcoming Milestones

Corporate

In 4Q17, Molecular expanded its senior management team with the additions of Adam Cutler as Chief Financial Officer; Barbara Ruskin J.D. Ph.D. as SVP, General Counsel and Chief Patent Officer; Nenad Sarapa M.D. M.S. as SVP of Clinical Development, and Conrad Jordaan as SVP of Finance and Corporate Controller.
On March 2, 2018, Molecular closed a $10 million debt facility with Perceptive Advisors. The proceeds were used to repay an existing debt facility with Silicon Valley Bank and will support Molecular’s build out of its GMP manufacturing facility, which should shorten the time from lead development to IND and better support Molecular’s own pipeline as well as partnerships.
MT-3724

MT-3724 (an ETB targeting CD20) is in an ongoing Phase Ib expansion study intended to better define the overall response rate to this candidate as a single-agent in heavily pre-treated diffuse large B-cell lymphoma (DLBCL) patients.
A brief update on the first three patients dosed in the MT-3724 Phase Ib expansion study was delivered at the World ADC Summit Europe today. Observations included the following:
One of the three patients achieved a partial response (PR) after a single dose of MT-3724. The PR was confirmed at the end of cycle 2 per protocol and the patient remains on study with continued dosing of MT-3724. The other two patients were assessed as having stable disease (SD) and progressive disease (PD).
A dose interruption and reduction was required in two of the first three patients in Phase Ib expansion. These patients had high body weights which resulted in high absolute doses of MT-3724 based on 75 mcg/kg dosing. The adverse events observed (grade 2 and 3) were reversible and dosing resumed at 50 mcg/kg, which has been generally well tolerated.
Based on these data, the deep and sustained clinical responses to MT-3724 observed at doses as low as 5 mcg/kg, as well as the near-complete peripheral B-cell depletion at doses up to 50 mcg/kg, the maximum tolerated dose (MTD) of MT-3724, has been defined as 50 mcg/kg with a maximum total drug per dose of 6,000 mcg, or 6 mg.
Enrollment in the Phase Ib expansion study continues, with further updates on results expected in 2Q18.
Nine DLBCL patients with low serum levels of rituximab have been treated at doses ranging from 5 mcg/kg to 75 mcg/kg in the Phase I dose-finding and Phase Ib expansion studies. In these nine patients, one complete response, two partial responses, three patients with stable disease (including one patient with a 48% reduction in tumor size), and three patients with progressive disease, were observed.
Based on the peripheral B-cell depletion observed at 50 mcg/kg and responses seen at doses as low as 5 mcg/kg, 50 mcg/kg appears to be an efficacious and well-tolerated dose.
Molecular also expects to initiate combination studies with MT-3724 in earlier lines of DLBCL therapy in 2Q18.
Takeda Collaboration

In December 2017, Takeda selected two targets for further research using Molecular’s ETBs. This has triggered $4 million in milestone payments to be paid by Takeda in 2018.
Takeda and Molecular are evaluating CD38 ETBs and could select a drug candidate for development by the end of 2Q18.
MT-4019

MT-4019, an ETB candidate that is designed to target CD38-expressing myeloma cancer cells, is progressing through IND enabling studies. If Takeda and Molecular do not select a joint candidate for development, Molecular anticipates filing an IND application for MT-4019 in mid-2018 to initiate a Phase I clinical trial in the United States in 2H18.
Research

Preclinical data for Molecular’s ETBs targeting PD-L1 (which incorporates Molecular’s Antigen Seeding Technology – a differentiated immune-oncology approach) and HER2 will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2018
Molecular expects to file an IND application for an ETB targeting HER2 in 4Q18
Molecular expects to file an IND application for an ETB targeting PD-L1 (with antigen seeding) in 1Q19
Several other ETB candidates are in preclinical development targeting both solid and hematological cancers
Financial Results

The net loss attributable to common shareholders for the fourth quarter was $6.9 million, or $0.26 per basic and diluted share. This is compared to a net loss attributable to common shareholders for the same period in 2016, of $2.9 million, or $13.82 per basic and diluted share.

Revenues for the fourth quarter of 2017 were $0.8 million, compared to $0.4 million for the same period in 2016. Revenues in the fourth quarters of 2017 and 2016 were comprised of grant revenue from the Cancer Prevention & Research Institute of Texas ("CPRIT"). Total research and development (R&D) expenses for the fourth quarter of 2017 were $4.7 million, compared with $1.7 million for the same period in 2016. Total general and administrative (G&A) expenses for the fourth quarter of 2017 were $3.5 million, compared with $1.1 million for the same period in 2016.

Revenues for the year ended December 31, 2017 were $3.4 million, compared to $1.9 million for 2016. These revenues were primarily comprised of research and development revenues from our collaboration with Takeda of $1.9 million, and grant revenue from CPRIT of $1.0 million. Revenues for the same period in 2016 comprised of grant revenue from CPRIT. Total R&D expenses for the year ended December 31, 2017 were $9.5 million, compared to $8.0 million for 2016. Total G&A expenses for the year ended December 31, 2017 were $11.8 million, compared to $4.5 million for 2016.

The net loss attributable to common shareholders for the year ended December 31, 2017 was $24.1 million, or $2.11 per basic and diluted share, compared to a net loss attributable to common shareholders of $12.6 million or $59.04 per basic and diluted share, for 2016. As of December 31, 2017, cash and cash equivalents totaled $58.9 million. Molecular’s current cash balance is expected to fund operations into late 2019.