On November 9, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported preliminary biomarker data from the ongoing Phase 2 clinical trial of sitravatinib in combination with nivolumab (OPDIVO) in non-small cell lung cancer (NSCLC) patients at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C (Press release, Mirati, NOV 9, 2018, View Source [SID1234531183]). The data will be presented today in a poster and also in an oral presentation on Saturday, November 10th.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The ongoing Phase 2 clinical trial is evaluating the safety and efficacy of sitravatinib in combination with an anti-PD-1 immune checkpoint inhibitor, in patients who have experienced documented disease progression following prior checkpoint inhibitor therapy. Efficacy data were recently presented at the October 2018European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The data demonstrated a higher rate of durable responses than would be expected from treatment with docetaxel, the standard of care. Today’s presentation, "Preliminary Biomarker Analysis of Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor", highlighted an initial assessment of correlative biomarkers for the 56 evaluable patients from the on-going clinical trial. Exploratory baseline and dynamic biomarker endpoints were evaluated for correlation with clinical outcomes.

The analysis demonstrated a CD8+ T effector cell response in patients who achieved a clinical benefit, suggesting a therapy-driven restoration of the anti-tumor immune response in patients who had become refractory to prior checkpoint inhibitor treatment. The data suggest that patients with high PD-L1 at baseline may be more likely to benefit from treatment with the combination although the difference was not statistically significant. There was no difference in treatment outcomes for patients based on their baseline tumor mutational burden or other baseline biomarkers.

"We are encouraged that we observed clear evidence of an adaptive immune response in our Phase 2 clinical trial evaluating sitravatinib in combination with nivolumab. This suggests that the mechanism of sitravatinib is mediated, at least in part, by its effect on immune cell populations and that an anti-tumor immune response can be restored by sitravatinib administered with checkpoint therapy," said James Christensen, Ph.D., Chief Scientific Officer, Mirati Therapeutics. "We will continue to evaluate correlative endpoints as clinical trial data mature and determine whether biomarkers can be utilized to select patients who are most likely to benefit."

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.

On November 9, 2018 Medtronic plc (NYSE:MDT) reported that it will report financial results for the second quarter of fiscal year 2019 on Tuesday, November 20, 2018. A news release will be issued at approximately 5:45 a.m. Central Standard Time (CST) and will be available at View Source The news release will include summary financial information for the company’s second quarter of fiscal year 2019, which ended on Friday, October 26, 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Medtronic will host a webcast at 7:00 a.m. CST to discuss financial results for its second quarter of fiscal year 2019. The webcast can be accessed at View Source on November 20, 2018.

Within 24 hours of the webcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source.

Looking ahead, Medtronic plans to report its fiscal year 2019 third and fourth quarter financial results on Tuesday, February 19, 2019, and Thursday, May 23, 2019, respectively. Medtronic plans to report its fiscal year 2020 first quarter on Tuesday, August 20, 2019. Confirmation and additional details will be provided closer to the specific event.

On November 9, 2018 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the third quarter ended September 30, 2018 and a business update (Press release, Adamis Pharmaceuticals, NOV 9, 2018, View Source [SID1234531098]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "The third quarter of 2018 was a significant one for Adamis. We opened the quarter by announcing an agreement with Sandoz to sell and distribute Symjepi in the U.S. In August, we strengthened our cash position with an underwritten equity offering which netted approximately $37.6 million and closed the quarter by announcing FDA approval for our Symjepi low dose (0.15 mg) product. This represents our second approved product using our Symject injectable platform. In addition, the company continued product development on our late-stage product candidates including the naloxone injection (APC-6000) and beclomethasone HFA (APC-1000) and announced the addition of a sublingual tadalafil product candidate to the development pipeline. To continue this momentum, Adamis is targeting additional milestones for the fourth quarter."

Product Updates

Symjepi (epinephrine) Injections (0.30mg and 0.15mg)

In the third quarter, the company entered into a commercialization and distribution agreement with Sandoz, a division of Novartis, to market and sell Symjepi in the U.S. The company also granted Sandoz a right of first negotiation for territories outside the U.S. On September 27th, the FDA approved the lower dose (0.15mg) Symjepi product. The company is continuing to support Sandoz in preparing for the commercial launch of both products.

APC-8000 (sublingual tadalafil)

The company has completed the testing of its sublingual tadalafil tablet product candidate in human patients. If analysis of the results of the testing is positive, the company’s goal is to file a New Drug Application (NDA) before the end of the fourth quarter.

APC-6000 (naloxone)

Progress has continued on the company’s naloxone injection product candidate for the treatment of opioid overdoses. Drug overdoses are now the leading cause of death for Americans under 50 years of age. According to statistics published by the Centers for Disease Control and Prevention (CDC), in 2017 drug overdoses resulted in approximately 72,000 deaths in the United States. The proliferation of more powerful synthetic opioids, such as fentanyl, may lead to an increase in the number of deaths from opioid overdoses. The company’s goal is to file an NDA before the end of the fourth quarter.

APC-1000 (beclomethasone)

With development complete on the company’s beclomethasone metered dose inhaler, and with the clearance from the FDA to begin Phase 3 trials, Adamis intends to begin enrolling patients into the pivotal study in December.

APC-4000 (fluticasone)

Development and manufacturing for the patented "dry powder inhaler" technology that the company acquired from 3M was completed in the first half of the year. We are now completing the drug development work, which includes loading the drug substance onto the tape in order to demonstrate proper dosing.

Drug Outsourcing Division

The company’s wholly-owned subsidiary, US Compounding received notice of allowance for a patent in the US for its novel combination product for treating and/or preventing gastrointestinal conditions including ulcers in horses and other livestock. This patent will strengthen its portfolio of veterinary products.

Third Quarter Financial Results

Revenues were approximately $3.8 million and $3.4 million for the three months ended September 30, 2018 and 2017, respectively. The increase in revenues for the three months ended September 30, 2018, compared to the comparable period of 2017, reflected an increase in sales of USC’s compounded and non-compounded pharmaceutical formulations.

Selling, general and administrative expenses ("SG&A") for the three months ended September 30, 2018 and 2017 were approximately $6.5 million and $5.7 million, respectively. Compensation expense for SG&A employees increased by approximately $409,000 for the three months ended September 30, 2018, compared to the comparable period of 2017, primarily due to new hires, increases in salary expenses and bonus accruals, and expenses associated with stock options grants and other employee benefits. SG&A expenses for the third quarter of 2018 compared to the comparable period of 2017, also increased by approximately $96,000 in patent expenses and $76,000 in PDUFA fees. Approximately $206,000 of the increase in the 2018 period compared to the same period of 2017 was due to increases in accounting, audit and other professional fees, depreciation, selling expenses, IT consulting expenses, taxes, travel expenses and other related expenses.

Research and development expenses were approximately $3.9 million and $1.2 million for the three months ended September 30, 2018 and 2017, respectively. The increase in research and development expenses for the three months ended September 30, 2018, compared to the comparable period of the prior year was due in part to an increase of approximately $2.5 million in development costs of our product candidates. This amount was partially offset by a decrease of approximately $134,000 in development costs primarily attributable to the APC-1000 and APC 5000 product candidates. Compensation expense for research and development increased by approximately $339,000 for the three months ended September 30, 2018, compared to the comparable period of 2017, primarily due to new hires, increases in salary expenses and bonus accruals, and expenses associated with stock options grants and other employee benefits. The company expects that research and development spending in the fourth quarter of 2018 will see an increase due to advancement of the company’s pipeline development activities, which may include FDA filing fees for NDAs for the naloxone and tadalafil product candidates if those NDAs are filed before the end of 2018, fees and costs associated with initiating a Phase 3 trial for the beclomethasone product candidate, and other spending and expenses relating to our pipeline product candidates, related regulatory expenses and other development expenses.

At September 30, 2018, the Company had cash and cash equivalents of $32.0 million.

Net cash used in operating activities for the nine months ended September 30, 2018 and 2017, was approximately $20.4 million and $9.9 million, respectively. Net cash used in operating activities increased primarily due to the decrease in gross profit and the increase in operating expenses.

Targeted Future Milestones

Commercial launch of Symjepi (epinephrine) Injection 0.3mg and 0.15mg in the U.S.;
Announcement of a commercial partner on Symjepi for territories outside the U.S.;
Filing an NDA for the naloxone injection product candidate;
Filing an NDA for the sublingual tadalafil product candidate;
Initiate pivotal Phase 3 studies of the beclomethasone product candidate in asthmatics;
Growing net revenue of the company’s outsourcing facility (US Compounding) by 30% over 2017.

On November 9, 2018 Cerus Corporation (Nasdaq:CERS) reported that William ‘Obi’ Greenman, Cerus’ president and chief executive officer, and Vivek Jayaraman, Cerus’ chief commercial officer, are scheduled to present a corporate update at the 2018 Canaccord Genuity Medical Technologies and Diagnostics Forum at 1:30 p.m. ET on Thursday, November 15, 2018 (Press release, Cerus, NOV 9, 2018, View Source;Diagnostics-Forum/default.aspx [SID1234531218]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available from the Investor Relations page of the Cerus web site at View Source A replay will be available for approximately two weeks following the completion of the

On November 9, 2018 Cytori Therapeutics, Inc. (NASDAQ: CYTX) reported that it will provide a live webcast of its third quarter financial results and business update on Wednesday, November 14, 2018 at 5:30 PM Eastern Time (Press release, Cytori Therapeutics, NOV 9, 2018, View Source [SID1234531153]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The dial-in information is as follows:
Dial-In Number: +1.877.402.3914
Conference ID: 9699923

Prior to the webcast at approximately 4:30 PM Eastern Time on November 14, Cytori will issue its third quarter earnings release which will review Cytori’s third quarter and year-to-date performance. The webcast will be available both live and by replay two hours after the call in the "Webcasts" section of the company’s investor relations website.