On November 8, 2017 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported results for its first quarter ended September 30, 2017 (Press release, MEI Pharma, NOV 8, 2017, View Source [SID1234521744]).

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"In this first quarter of the new fiscal year we announced an important milestone with the dosing of the first patient in the pivotal Phase 3 study of pracinostat in combination with azacitidine in adults with newly diagnosed acute myeloid leukemia (AML) who are unfit to receive intensive induction chemotherapy. In addition, we announced that we had further strengthened our oncology clinical pipeline with the addition of the clinical-stage cyclin-dependent kinase (CDK) inhibitor voruciclib," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We are well positioned for a momentous year ahead, with a healthy cash balance and a series of key milestones in each of our clinical programs."

Upcoming Milestones

Pracinostat

Expecting results from Stage 1 of a Phase 2 dose-optimization study in myelodysplastic syndrome (MDS) in the first half of 2018.
ME-401

Expecting to initiate combination study with Rituxan in indolent lymphoma & diffuse large B-cell lymphoma (DLBCL) in the fourth quarter of 2017.
Expecting results from proof-of-concept study in relapsed/refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma to be presented at a scientific meeting in the first half of 2018.
Voruciclib

Expecting to initiate Phase1/2 single-agent study in relapsed/refractory B lymphocyte malignancies and subsequently in a combination study with venetoclax (marketed as Venclexta) in the second quarter of 2018.
ME-344

Expecting interim results from the proof-of-concept study in human epidermal growth factor receptor 2 (HER2) negative breast cancer in combination with bevacizumab (marketed as Avastin) in the first half of 2018.
Financial Highlights

As of September 30, 2017, MEI Pharma had $47.0 million in cash, cash equivalents and short-term investments, with no outstanding debt. The Company believes its cash position will be sufficient to fund operations into calendar year 2019.
Cash used in operating activities was $6.6 million for the three months ended September 30, 2017, compared to cash provided by operating activities of $8.8 million for 2016. Included in cash expenditures for the three months ended September 30, 2017 was $1.9 million cash paid for the voruciclib acquisition. Included in the cash provided by operating activities in 2016 is the $15 million upfront payment from Helsinn for pracinostat.
Research and development expenses, including cost of research and development revenue, were $6.7 million for the three months ended September 30, 2017, compared to $2.7 million for 2016. The increase was primarily due to the acquisition of voruciclib and increased costs for ME-401, offset by a reduction in expenses related to pracinostat.
General and administrative expenses were $2.5 million for the three months ended September 30, 2017, compared to $2.7 million for 2016. The decrease was primarily due to professional service costs incurred in 2016 related to the Helsinn license agreement.
Revenues were $0.3 million for the three months ended September 30, 2017, compared to $1.1 million in 2016. The decrease is related to activities performed pursuant to the Helsinn license agreement.
Net loss was $8.8 million, or $0.24 per share, for the three months ended September 30, 2017, compared to a net loss of $4.3 million, or $0.12 per share for the three months ended September 30, 2016

On November 8, 2017 Medtronic plc (NYSE:MDT) reported its preliminary revenue for its second quarter of fiscal year 2018, which ended October 27, 2017. The company announced preliminary second quarter worldwide revenue of approximately $7.050 billion, a decrease of 4 percent as reported, with the decline driven by the company’s divestiture of its Patient Care, Deep Vein Thrombosis (Compression), and Nutritional Insufficiency businesses to Cardinal Health that occurred at the beginning of the quarter. Second quarter revenue increased 3 percent on a comparable, constant currency basis, which adjusts for the divestiture and a $35 million positive impact from foreign currency (Press release, Medtronic, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315619 [SID1234521801]). Excluding the impact of Hurricane Maria, second quarter revenue growth would have been 4 percent on a comparable, constant currency basis.

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The company announced that the impact of Hurricane Maria was approximately $55 to $65 million to its second quarter revenue and is expected to be approximately $0.03 to its second quarter non-GAAP earnings per share (EPS). The company was able to limit the financial impact versus its original expectations provided on October 6th due to the performance and resilience of its employees driving a faster-than-anticipated recovery of its operations in Puerto Rico. As expected, the majority of the impact was to its Minimally Invasive and Restorative Therapies Groups in the United States.

On September 20th, Hurricane Maria devastated the island of Puerto Rico and incapacitated Medtronic’s four manufacturing plants. Within two weeks, on October 2nd the company had substantially repaired its four Puerto Rico manufacturing facilities and restarted limited production, with production reaching 50 to 60 percent capacity by October 9th, and ramping to near pre-hurricane capacity by October 18th.

Medtronic’s primary focus has been to support the well-being of its more than 5,000 direct and contract employees on the island and restore its operations to full productivity. The company has and continues to provide critical supplies for its people in Puerto Rico, including water, food, temporary housing, medical care, counseling services, child care, laundry facilities, and power generators.

Despite ongoing island infrastructure challenges, the company is now fully prepared for sustained operations on the island. Medtronic took several actions to restore its manufacturing operations, including implementing on-site and redundant power generator systems; alternate technologies for telecommunication and data connectivity; access to critical suppliers and production materials; and shipping, transportation, and logistics capabilities. As a result, the company was able to minimize the impact of the hurricane on both its supply to customers as well as the company’s second quarter financial results.

"The creativity, dedication, and persistence of our employees – both on and off the island – in dealing with the aftermath of Hurricane Maria was simply incredible. In particular, our employees in Puerto Rico made countless selfless contributions, despite extensive impact to their personal lives, coming to work every day to ensure customers and patients worldwide received our products," said Omar Ishrak, Medtronic chairman and chief executive officer. "Through the efforts of our team, along with help from the local government and the U.S. FDA, we were able to achieve extraordinary results with our Puerto Rico operations over the month of October, well exceeding our initial expectations. I am extremely proud of our passionate employees whose tireless dedication was critical in restoring our operations."

Second Quarter EPS Guidance

Excluding the impact of Hurricane Maria, Medtronic today reiterated its expectation that second quarter adjusted EPS would be flat to slightly up on a comparable, constant currency basis from the prior year comparable EPS of $1.04. The company expects a one cent positive impact to adjusted EPS from foreign currency. Adjusted EPS guidance does not include any charges or gains that would be reported as non-GAAP adjustments to earnings.

Webcast Information

Medtronic will report financial results for the second quarter of fiscal year 2018 and provide an outlook for its fiscal year on Tuesday, November 21, 2017. This is one week earlier than the preliminary date previously provided by the company. A news release will be issued at approximately 5:45 a.m. Central Standard Time (CST) and will be available at View Source Medtronic will host a webcast at 7:00 a.m. CST to discuss its financial results. The webcast can be accessed at View Source on November 21, 2017. 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 2018 third and fourth quarter financial results on Tuesday, February 20, 2018, and Thursday, May 24, 2018, respectively. Confirmation and additional details will be provided closer to the specific quarterly earnings release date.

Non-GAAP Schedule

To view the Preliminary FY18 Second Quarter Non-GAAP Reconciliation schedule, click here. The document can also be accessed by visiting newsroom.medtronic.com.

On Nobember 8, 2017 Verseon, a technology-based pharmaceutical company employing a computer-driven platform to develop a diverse drug pipeline, reported its anticancer drug candidates at the BIO-Europe conference in Berlin yesterday (Press release, Verseon, NOV 8, 2017, View Source [SID1234521718]). Dr. Anirban Datta, Director of Discovery Biology, presented preclinical studies across a range of cancer cell lines, which show that the Company’s compounds may be especially well-suited for the treatment of multidrug resistant solid tumors.

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One of the most common ways in which cancer cells render chemotherapies ineffective is by triggering an overproduction of transport proteins that expel many organic substances, including drugs. The preclinical data presented at BIO-Europe demonstrate that Verseon’s drug candidates are significantly less susceptible to this mode of tumor resistance. In vitro studies furthermore show that the Company’s compounds maintain efficacy across multiple cell lines that are resistant to common chemotherapy agents.

Verseon’s drug candidates inhibit microtubule formation by targeting tubulin. They act against cancer cells by suppressing blood vessel growth and by interrupting the cell division cycle preventing mitosis, both proven treatment strategies for cancer. Lead candidates also show pharmacokinetics suitable for administration as infusion, an important prerequisite for inclusion in infusion-based chemotherapy regimens.

"There is an ongoing need for anticancer agents less susceptible to tumor resistance that can be used in conjunction with existing and new drugs," said Dr. Datta. "The fact that our tubulin inhibitors are mostly unaffected by major transporters could change the standard of care for cancer chemotherapy. In particular, using transporter overexpression as a biomarker to drive treatment decisions could lead to more effective precision second-line therapy."

About Verseon’s oncology program
Verseon plans to use its promising class of tubulin inhibitors to target multidrug resistant cancers. Several drug candidates show potency in functional and cellular assays. Furthermore, Verseon’s inhibitors maintain their efficacy across multiple chemotherapy-resistant cancer cell lines and are mostly unaffected by the overexpression of common transporters, a primary source of multidrug resistance.

Neuralstem has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Neuralstem, 2017, NOV 8, 2017, View Source [SID1234521752]).

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Cascadian Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Cascadian Therapeutics, 2017, NOV 8, 2017, View Source [SID1234521783]).

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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

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