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MIRATI THERAPEUTICS REPORTS THIRD QUARTER 2017 FINANCIAL RESULTS

On November 1, 2017 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, reported financial results for the third quarter 2017 (Press release, Mirati, NOV 1, 2017, View Source [SID1234521440]).

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“We are excited by the momentum we have created our programs, including sitravatinib as both a single agent and in combination with nivolumab (OPDIVO) where we reported promising clinical data in non-small cell lung cancer patients at medical conferences in September and October,” said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. “We remain on track to provide program updates on glesatinib, mocetinostat and KRAS by the end of the year.”

Third Quarter 2017 Financial Results

Cash, cash equivalents, and short-term investments were $75 million at September 30, 2017, compared to $56.7 million at December 31, 2016.

Research and development expenses for the third quarter of 2017 were $13.5 million, compared to $16.1 million for the same period in 2016. Research and development expenses for the nine months ended September 30, 2017 were $42.8 million, compared to $52.5 million for the same period in 2016. The decrease in research and development expenses for both the three and nine months ended September 30, 2017 is primarily due a decrease in third party research and development expense, including a reduction in glesatinib manufacturing expenses. In addition, share-based compensation expense decreased in the nine months ended September 30, 2017 compared to the same period of 2016 due to lower exercise prices for options granted during the last half of 2016 and most of 2017. These decreases in expenses are partially offset by increases in expenses associated with our ongoing sitravatinib Phase 1b clinical trial and early discovery costs.

General and administrative expenses for the third quarter of 2017 and 2016 were $3.1 million and $3.5 million, respectively. General and administrative expenses for the nine months ended September 30, 2017 were $10.5 million, compared to $11.4 million for the same period in 2016. The decrease in general and administrative expense is primarily due to a decrease in share-based compensation expense, which is due to lower exercise prices for options granted during the last half of 2016 and most of 2017.

Net loss for the third quarter of 2017 was $16.4 million, or $0.65 per share basic and diluted, compared to net loss of $19.4 million, or $0.97 per share basic and diluted for the same period in 2016. Net loss for the nine months ended September 30, 2017 was $52.5 million, or, $2.12 per share basic and diluted, compared to net loss of $63.4 million, or $3.21 per share basic and diluted for the same period in 2016.

[Topics] IR Meeting for FY2017 2nd Quarter Business Results[Material][Audio]

On November 1, 2017 Mitsubishi Tanabe Pharma presented 2nd Quarter Results results for FY2017 (Press release, Mitsubishi Tanabe Pharma, NOV 1, 2017, View Source [SID1234521441])

[Topics] IR Meeting for FY2017 2nd Quarter Business Results[Material][Audio]

On November 1, 2017 Mitsubishi Tanabe Pharma presented financial results for FY2017 (Press release, Mitsubishi Tanabe Pharma, NOV 1, 2017, View Source [SID1234521441])

Pain Therapeutics Reports Third Quarter 2017 Financial Results

On November 1, 2017 Pain Therapeutics, Inc. (Nasdaq:PTIE) reported financial results for the third quarter ended September 30, 2017. Net loss for the third quarter of 2017 was $2.6 million, or $0.40 per share, respectively, compared to a net loss for the same period in 2016 of $3.5 million, or $0.54 per share (Press release, Pain Therapeutics, NOV 1, 2017, View Source [SID1234521444]). Net cash used during the third quarter was $2.2 million. Cash and investments were $11.9 million as of September 30, 2017, with no debt. The Company still expects net cash usage in the calendar year 2017 may be approximately $10 million. Following the resubmission of the REMOXY NDA in Q1 2018, the Company believes net cash usage in 2018 will decrease significantly compared to 2017.

“The White House recently declared the opioid epidemic a public health emergency,” said Remi Barbier, President & CEO. “We fully support this policy position, and have been a voice in support of such a policy for many years. Nearly 15 years ago, Pain Therapeutics pioneered abuse-deterrent technology for opioid drugs specifically to provide policy makers, regulators, physicians, pharmacists and patients an additional tool to help combat the opioid epidemic. In partnership with all constituents, we look forward to doing our part to address the issues of overdose and death from extended-release opioid drugs.”

Operating Highlights for Q3 2017

In September, the National Institutes of Health (NIH) awarded us a $1.8 million research grant to develop a blood-based diagnostic to detect Alzheimer’s disease.
In September, The National Institute on Drug Abuse (NIDA) awarded us a $2.2 million research grant to further develop FENROCK, an abuse-deterrent transdermal patch that contains the prescription drug fentanyl.
In October, we announced a successful Phase I clinical study for PTI-125, our drug candidate for the treatment of Alzheimer’s disease. As previously announced, our scientists plan to present full results of this study at the 10th Annual International Conference on Clinical Trials on Alzheimer’s Disease, in Boston, MA, on November 1-4th.
In October, we announced the FDA had agreed to a pre-NDA guidance meeting on November 14th to discuss the upcoming resubmission of an NDA for REMOXY ER. We will provide details of this FDA meeting after receipt of final meeting minutes.
Recently, we substantially completed a previously announced human nasal study with REMOXY ER. We plan to announce top-line results of this study by yearend 2017.
Financial Highlights for Q3 2017

At September 30, 2017, cash and investments were $11.9 million, compared to $14.1 million at June 30, 2017. The Company has no debt.
Net cash used during the three months ended September 30, 2017 was $2.2 million.
Research and development expenses for the three months ended September 30, 2017 decreased to $1.6 million, respectively, from $2.7 million for the same period in 2016, primarily due to decreases in REMOXY related expenses and the receipt of research grant funding from the National Institutes of Health for FENROCK and PTI-125, recorded as a reduction in research and development expenses activities. Research and development expenses included non-cash stock-related compensation of $0.3 million in both three months ended September 30, 2017 and 2016.
General and administrative expenses increased slightly to $1.0 million in the three months ended September 30, 2017 from $0.9 million for the same period in 2016. General and administrative expenses included non-cash stock-related compensation of $0.4 million in the three months ended September 30, 2017 compared to $0.5 million for same period in 2016.
About REMOXY ER (extended-release oxycodone capsules CII)
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for “the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” We developed REMOXY to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY’s thick, sticky, high-viscosity gel-cap formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking.

About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, oxycodone abuse and diversion remains a serious, persistent problem. Drug overdose deaths exceeded 64,000 in 2016, according to the CDC. For over a decade, Pain Therapeutics has pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight against prescription drug abuse. ADFs attempt to raise the bar on prescription drug abuse by making it difficult, longer or aversive to tamper with long-acting opioid formulations, recognizing that no drug can be made abuse-proof.

vTv Therapeutics Reports Third Quarter 2017 Financial and Operational Results

On November 1, 2017 vTv Therapeutics Inc. (vTv Therapeutics) (Nasdaq:VTVT) reported a corporate update and reported financial and operational results for the third quarter ended September 30, 2017 (Press release, vTv Therapeutics, NOV 1, 2017, View Source [SID1234521445]).

“We’ve made significant progress in the third quarter of 2017 across our strategic initiatives, and we attribute that to our ongoing development of innovative therapies, particularly in the areas of Alzheimer’s and diabetes,” said Steve Holcombe, president and CEO of vTv Therapeutics. “We look forward to building on this momentum as we approach several important milestones next year, including the Part A readout out of our Phase 3 STEADFAST Study of azeliragon in patients with mild Alzheimer’s disease.”

Third Quarter 2017 Highlights

Issuance of U.S. Patent Covering Methods of Treatment Using Azeliragon

The U.S. Patent and Trademark Office issued patent number 9,717,710 (‘710 Patent) with claims protecting methods of treatment using azeliragon, vTv Therapeutics’ oral antagonist of the Receptor for Advanced Glycation Endproducts (RAGE) for treatment of mild Alzheimer’s disease. The ‘710 Patent, expiring in October 2034, includes claims covering methods of treating patients with mild Alzheimer’s disease by administering about 5 mg per day of azeliragon.
2017 Alzheimer’s Association International Conference

In two poster presentations titled, “Assessment of Azeliragon QTc Liability through Integrated, Model-Based Concentration QTc Analysis” and “Effect of Food on the Pharmacokinetics of Azeliragon in Healthy Adult Subjects,” vTv Therapeutics’ researchers reviewed study data that indicated no deleterious effect of azeliragon on QT at therapeutic and supra-therapeutic doses and that azeliragon may be given without regard to meals.
vTv Therapeutics and JDRF Enter Into Industry Partnership

JDRF, the leading global organization funding type 1 diabetes (T1D) research, committed $3 million in funding, matched by vTv Therapeutics, to support a Phase 2 Proof of Concept study to explore the effect of vTv Therapeutics’ liver-selective glucokinase activator TTP399 as an oral drug for the treatment of T1D. The study will evaluate whether TTP399 is well tolerated when administered as an add-on to insulin therapy for people with T1D and whether TTP399 has the potential to significantly improve daily glucose profiles and HbA1c.
53rd European Association for the Study of Diabetes Annual Meeting

In a poster presentation titled “Beyond topline results for the oral (non-peptide) GLP-1R agonist TTP273 in type 2 diabetes: How much and when?” vTv Therapeutics’ researchers reviewed results from a concentration/effect analysis on the LOGRA study showing that lower doses of TTP273 may show more pronounced effects for key efficacy endpoints, including a reduction in HbA1c, weight, and fasting plasma glucose.
Upcoming Anticipated Milestones

STEADFAST Study (azeliragon in patients with mild Alzheimer’s disease): Expected to report top-line results from each of the Part A and Part B studies in early 2018 and late 2018, respectively.

Third Quarter 2017 Financial Results

Cash Position: Cash and cash equivalents as of September 30, 2017 were $20.5 million compared to $32.5 million as of June 30, 2017.
R&D Expenses: Research and development expenses were $9.0 million in the third quarter of 2017, compared to $9.6 million in the second quarter of 2017. The decrease in research and development expenses was primarily driven by decreases in spending for the STEADFAST Study due to the relative costs of patient visits.
G&A Expenses: General and administrative expenses were $2.6 million and $3.0 million, for the third and second quarters of 2017, respectively. The decrease in general and administrative costs was primarily due to the reduction in professional service fees between the periods.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $12.4 million for the third quarter of 2017 compared to net loss before non-controlling interest of $13.4 million for the second quarter of 2017.
Net Loss per Share: GAAP net loss per share was $0.38 and $0.41 for the three months ended September 30, 2017 and June 30, 2017, respectively, based on weighted-average shares of 9.7 million in each period. Non-GAAP net loss per fully exchanged share was $0.38 and $0.41 for the three months ended September 30, 2017 and June 30, 2017, respectively, based on non-GAAP fully exchanged weighted-average shares of 32.8 million in each period.