On November 21, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported Walter Klemp, Chairman and Chief Executive Officer and Jonathan Foster, Chief Financial Officer will present at the 10th Annual LD Micro Main Event on Tuesday, December 5, 2017 at 11:30 a.m. PT (2:30 p.m. ET) in Track 5 (Press release, Moleculin, NOV 21, 2017, View Source [SID1234522198]). The conference is being held at the Luxe Sunset Boulevard Hotel in Los Angeles, CA.

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Management will be available for one-on-one meetings on Tuesday, December 5, 2017. Investors interested in arranging a meeting with management should contact their LD Micro representative or Lytham Partners at (602) 889-9700 or [email protected].

On November 21, 2017 Cancer Prevention Pharmaceuticals (CPP), a clinical stage biotechnology company, reported it will give a corporate presentation at the Piper Jaffray 29th Annual Healthcare Conference on November 28, 7:50-8:10 a.m. ET at the Lotte New York Palace in New York City (Track Seven: Kennedy 2, 4th floor) (Press release, Cancer Prevention Pharmaceuticals, NOV 21, 2017, http://canprevent.com/wp-content/uploads/2013/08/CPP-Piper-Jaffray-Conference-FINAL-2017-11-21.pdf [SID1234522220]). CPP CEO Jeff Jacob will give an update on the company’s pipeline including its lead Phase 3 drug CPP-1X/sul for treatment of familial adenomatous polyposis (FAP). CPP recently engaged Piper Jaffray to support its anticipated financing activities.

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FAP is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. In June, an Independent Data Monitoring Committee (IDMC) recommended continuation of the Phase 3 trial following a planned interim futility analysis. In September, the U.S. Food and Drug Administration granted CPP-1X/sul "fast track" status, potentially speeding regulatory approval and commercialization.

In 2016 CPP signed a collaboration agreement with Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) that grants Sucampo the sole option to acquire an exclusive license to commercialize CPP-1X/sul in North America. Sucampo recently highlighted CPP-1X/sul during their 2017 R&D Day in New York City.

For more information on the FAP clinical trial (CPP FAP-310), please visit: View Source

On November 21, 2017 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported its financial results for the third quarter ended September 30, 2017 (Press release, BioLineRx, NOV 21, 2017, View Source;p=RssLanding&cat=news&id=2318081 [SID1234522187]).

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Highlights and achievements during the third quarter 2017 and to date:

Continued execution on multiple clinical development studies for BL-8040, the Company’s lead oncology program:

Initiation of two additional Phase 1b/2 studies under collaboration with Genentech, following the first study which was initiated in July 2017. All studies are exploring the combination of BL-8040 with Tecentriq (atezolizumab), Genentech’s anti-PDL1 cancer immunotherapy agent.
Phase 1b/2 trial for the maintenance treatment of patients with intermediate- and high-risk acute myeloid leukemia (AML) who have achieved complete response (CR) following induction and consolidation therapy.
Phase 1b/2 trial for the treatment of gastric cancer. This study is conducted as part of MORPHEUS, Roche’s Novel Cancer Immunotherapy Development Platform.
Completion of enrollment to the COMBAT study, which is investigating the combination of BL-8040 and Merck’s PD-1 inhibitor, Keytruda, in the treatment of pancreatic cancer patients.
Regulatory submission to initiate Phase 3 pivotal study with BL-8040 as novel stem cell mobilization treatment for autologous bone-marrow transplantation, expected to commence by the end of 2017, following receipt of regulatory approvals; and

Several abstracts accepted to key scientific conferences:
Oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2017 of pre-clinical data supporting BL-8040 as a robust mobilizer of hematopoietic stem cells associated with long-term engraftment.
Poster presentation at the ASCO (Free ASCO Whitepaper) GI conference of partial results from the monotherapy portion of the Phase 2a COMBAT study in pancreatic cancer. The abstract for this presentation will be published prior to the conference in January 2018.

Expected significant upcoming milestones for 2017 and 2018:

Partial results from immuno-oncology Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck’s KEYTRUDA, expected to be announced at ASCO (Free ASCO Whitepaper) GI conference in January 2018; top line results expected in H2 2018;
Initiation of Phase 3 pivotal study for BL-8040 in stem-cell mobilization for autologous transplantation, expected by the end of 2017;
Initiation of Phase 1b/2 immuno-oncology study for BL-8040 in combination with Genentech’s atezolizumab for non-small cell lung cancer, expected by early 2018. Partial results in Phase 1b/2 solid tumors and AML trials in collaboration with Genentech are expected in H2 2018;
Initiation of Phase 1 immuno-oncology study for AGI-134 in several solid tumor indications expected in H1 2018;
Top-line results of Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by mid-2018.

Philip A. Serlin, Chief Executive Officer of BioLineRx, remarked, "We are pleased to report third quarter-to-date activities that continue to demonstrate clinical and regulatory execution on our multiple programs. This included timely initiation of the studies under our cancer immunotherapy collaboration with Genentech for gastric cancer and AML, as well as finalization of all preparations for initiation of our Phase 3 GENESIS study in stem cell mobilization. We are also very excited about the completion of enrollment to the COMBAT study, which will allow us to report topline results as planned in H2 2018. By year-end 2017, we remain on track to have one Phase 3 and seven Phase 2 or 1b/2 clinical trials up and running, and in January 2018 we plan to announce partial results from our Phase 2 study in pancreatic cancer under our immunotherapy collaboration with Merck."

Financial Results for the Third Quarter Ended September 30, 2017

Research and development expenses for the three months ended September 30, 2017 were $5.7 million, an increase of $2.7 million, or 91.4%, compared to $3.0 million for the three months ended September 30, 2016. The increase resulted primarily from spending on the recently acquired AGI-134 near-clinical project and from higher expenses in 2017 associated with new BL-8040 studies commenced during the third quarter of 2016 and during 2017. Research and development expenses for the nine months ended September 30, 2017 were $13.3 million, an increase of $5.1 million, or 61.6%, compared to $8.2 million for the nine months ended September 30, 2016. The reason for the increase is the same as that presented in the three-month comparison above.

Sales and marketing expenses for the three months ended September 30, 2017 were $0.2 million, a decrease of $0.2 million, or 39.1%, compared to $0.4 million for the three months ended September 30, 2016. The decrease resulted primarily from market research activities related to BL-8040, as well as legal expenses related to business development collaborations and in-licensing activities, in the 2016 period. Sales and marketing expenses for the nine months ended September 30, 2017 were $1.2 million, an increase of $0.3 million, or 31.2%, compared to $0.9 million for the nine months ended September 30, 2016. The increase resulted primarily from one-time legal fees related to AGI-134.

General and administrative expenses for the three months ended September 30, 2017 were $1.1 million, similar to the comparable period in 2016. General and administrative expenses for the nine months ended September 30, 2017 were $3.0 million, similar to the comparable period in 2016.

The Company’s operating loss for the three months ended September 30, 2017 amounted to $7.1 million, compared with an operating loss of $4.5 million for the corresponding 2016 period. The Company’s operating loss for the nine months ended September 30, 2017 amounted to $17.6 million, compared with an operating loss of $12.1 million for the corresponding 2016 period. The increase in operating loss reflects a significant increase in research and development expenses for the respective periods.

Non-operating income (expenses) for the three and nine months ended September 30, 2017 and 2016 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet. Non-operating expenses for the three-month and nine-month periods ended September 30, 2017 primarily result from a $0.3 million fair-value adjustment of derivative liabilities on account of the warrants issued in the direct placement conducted in July 2017. These fair-value adjustments are highly influenced by the Company’s share price at each period end (revaluation date).

Net financial income amounted to $0.2 million for the three months ended September 30, 2017, similar to the comparable period in 2016. Net financial income amounted to $0.9 million for the nine months ended September 30, 2017 compared to net financial income of $0.4 million for the nine months ended September 30, 2016. The increase in net financial income relates primarily to gains recorded on foreign currency hedging transactions and higher investment income due to higher levels of cash and short-term bank deposits.

The Company’s net loss for the three months ended September 30, 2017 amounted to $7.2 million, compared with a net loss of $4.3 million for the corresponding 2016 period. The Company’s net loss for the nine months ended September 30, 2017 amounted to $17.0 million, compared with a net loss of $11.6 million for the corresponding 2016 period.

The Company held $55.0 million in cash, cash equivalents and short-term bank deposits as of September 30, 2017.

Net cash used in operating activities was $14.2 million for the nine months ended September 30, 2017, compared with net cash used in operating activities of $10.4 million for the nine months ended September 30, 2016. The $3.8 million increase in net cash used in operating activities during the nine-month period in 2017, compared to the nine-month period in 2016, was primarily the result of increased research and development expenses in the 2017 period.

Net cash used in investing activities for the nine months ended September 30, 2017 was $19.5 million, compared to net cash provided by investing activities of $7.3 million for the nine months ended September 30, 2016. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits, as well as the acquisition of Agalimmune and investment in iPharma.

Net cash provided by financing activities for the nine months ended September 30, 2017 was $37.7 million, compared to net cash provided by financing activities of $1.5 million for the nine months ended September 30, 2016. The increase in cash flows from financing activities primarily reflects our public offering completed in April 2017 and the registered direct placement completed in July 2017.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, November 21, 2017, at 10:00 a.m. EST. To access the conference call, please dial 1-888-407-2553 from the U.S. or +972-3-918-0664 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available approximately two hours after completion of the live conference call at the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until November 24, 2017; please dial 1-866-500-4953 from the U.S. or +972-3-925-5946 internationally.

On November 21, 2017 Medtronic plc (NYSE:MDT) reported financial results for its second quarter of fiscal year 2018, which ended October 27, 2017 (Press release, Medtronic, NOV 21, 2017, View Source;p=RssLanding&cat=news&id=2318070 [SID1234522197]).

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The company reported second quarter worldwide revenue of $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. Excluding the approximate $55 to $65 million impact of Hurricane Maria to the company’s revenue, which was split across the company’s Minimally Invasive Therapies Group and Restorative Therapies Group, second quarter revenue growth would have been 4 percent on a comparable, constant currency basis.

As reported, second quarter GAAP net income and diluted earnings per share (EPS) were $2.017 billion and $1.48, respectively. As detailed in the financial schedules included through the link at the end of this release, second quarter non-GAAP net income and diluted EPS were $1.456 billion and $1.07, decreases of 7 percent and 4 percent, respectively. Adjusting for the divestiture, a positive 1 cent impact from foreign currency, and the approximate 3 cent impact from Hurricane Maria, second quarter non-GAAP diluted EPS increased approximately 5 percent.

Second quarter U.S. revenue of $3.734 billion represented 53 percent of company revenue and decreased 10 percent as reported, or was flat on a comparable basis. Non-U.S. developed market revenue of $2.241 billion represented 32 percent of company revenue and increased 1 percent as reported, or 5 percent on a comparable, constant currency basis. Emerging market revenue of $1.075 billion represented 15 percent of company revenue and increased 9 percent as reported, or 12 percent on a comparable, constant currency basis.

"Our second quarter financial results are very encouraging, when considered in the context of a quarter in which we faced three hurricanes and the California wildfires. Hurricane Maria, in particular, significantly affected our manufacturing operations in Puerto Rico," said Omar Ishrak, Medtronic chairman and chief executive officer. "Against this backdrop, we delivered a sequential acceleration in our organic revenue growth, as expected."

Cardiac and Vascular Group

The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic & Peripheral Vascular (APV) divisions. CVG worldwide second quarter revenue of $2.773 billion increased 7 percent on both a reported and constant currency basis. CVG revenue performance was driven by strong, low-double digit growth in CSH and mid-single digit growth in CRHF and APV, all on a constant currency basis.

CRHF second quarter revenue of $1.467 billion increased 5 percent, or 4 percent on a constant currency basis. Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by high-teens growth in AF Solutions and low-double digit growth in Diagnostics, both on a constant currency basis, as well as strong adoption of the Micra(TM) Transcatheter Pacing System and TYRX(TM) absorbable antibacterial envelope. Heart Failure grew in the high-single digits on a constant currency basis, driven by strong demand for the company’s portfolio of quadripolar cardiac resynchronization therapy-pacemakers (CRT-P), as well as growth in Mechanical Circulatory Support.
CSH second quarter revenue of $854 million increased 13 percent, or 12 percent on a constant currency basis, led by high-thirties growth on a constant currency basis in transcatheter aortic valves on the strength of the recently launched CoreValve Evolut PRO and U.S. intermediate risk indication. In addition, the Coronary business returned to growth, driven by the company’s recent launch of the Resolute Onyx(TM) drug-eluting stent in the U.S. and Japan.
APV second quarter revenue of $452 million increased 5 percent, or 4 percent on a constant currency basis. Aortic growth was led by the solid adoption of the Heli-FX EndoAnchor System and solid performance of the Valiant Captivia thoracic stent graft systems. Peripheral was driven by double digit growth in both PTA balloons and drug-coated balloons. Mid-single digit growth in endoVenous was driven by the recently launched Concerto(TM) 3D detachable coil system.
Minimally Invasive Therapies Group

The Minimally Invasive Therapies Group (MITG) is now organized into the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions following the divestiture of its Patient Care, Deep Vein Thrombosis (Compression), and Nutritional Insufficiency (Enteral Feeding) businesses. MITG worldwide second quarter revenue of $1.952 billion decreased 21 percent as reported, or increased 2 percent on a comparable, constant currency basis. MITG second quarter revenue growth reflected mid-single digit growth in SI, which was affected by Hurricane Maria, offset by low-single digit declines in RGR.

SI second quarter revenue of $1.334 billion increased 4 percent on a comparable, constant currency basis, driven by new products in Advanced Stapling and Advanced Energy, including endo stapling specialty reloads, the Signia(TM) powered stapler, and LigaSure(TM) vessel sealing instruments.
RGR second quarter revenue of $618 million decreased 3 percent on a comparable, constant currency basis. The declines were driven by difficult comparisons in its Respiratory business following the return to market last year of the Puritan Bennett(TM) 980 ventilator.
Restorative Therapies Group

The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. RTG worldwide second quarter revenue of $1.863 billion increased 2 percent on both a reported and constant currency basis. Group results were driven by low-double digit growth in Brain Therapies, offsetting declines in Spine, Specialty Therapies, and Pain Therapies, all on a constant currency basis. Hurricane Maria primarily affected the Spine and Pain Therapies division, as well as the Pelvic Health business in the Specialty Therapies division.

Spine second quarter revenue of $659 million decreased 1 percent on both a reported and constant currency basis. Mid-single digit constant currency growth in Biologics worldwide and low-single digit constant currency growth in Core Spine in international markets was offset by mid-single digit declines in Core Spine in the U.S. as a result of the impact of Hurricane Maria.
Brain Therapies second quarter revenue of $575 million increased 14 percent, or 13 percent on a constant currency basis. Growth was driven by high-twenties constant currency growth in Neurovascular, with strength across its product portfolio. The Neurosurgery business grew in the mid-teens on a constant currency basis, led by strong sales of the StealthStation(TM) S8 surgical navigation system, O-arm2 surgical imaging system, Visualase MRI-guided laser ablation system, and Midas Rex surgical instruments.
Specialty Therapies second quarter revenue of $365 million decreased 1 percent on both a reported and constant currency basis. Mid-single digit global constant currency growth in Transformative Solutions, ENT, and high-single digit international constant currency growth in Pelvic Health was offset by mid-single digit declines in Pelvic Health in the U.S., with the declines driven by the impact of Hurricane Maria on InterStim II sales.
Pain Therapies second quarter revenue of $264 million decreased 8 percent, or 9 percent on a constant currency basis. Growth in Interventional Pain was offset by mid-teens declines in Spinal Cord Stimulation and mid-single digit declines in Pain Pumps, all on a constant currency basis, driven in part by the impact of Hurricane Maria.
Diabetes Group

The Diabetes Group includes the Intensive Insulin Management (IIM), Diabetes Service & Solutions (DSS), and Non-Intensive Diabetes Therapies (NDT) divisions. Diabetes Group worldwide second quarter revenue of $462 million was flat, or decreased 2 percent on a constant currency basis. The group is experiencing strong global demand for its new sensor-augmented insulin pump systems, and similar to the first quarter, growth was tempered as demand outpaced supply. The group’s ability to meet increasing patient demand has improved, as evidenced by the improved sequential revenue growth. In addition, the Diabetes Group’s capacity expansion plans for the second half of fiscal year 2018 are on track.

IIM second quarter revenue declined in the low-single digits on a constant currency basis. In the U.S., IIM experienced a 15 percent growth in new patients. This was offset by delays in converting its existing installed base to new pumps due to CGM sensor supply constraints. In international markets, IIM delivered high-single digit constant currency growth due to the continued strength of the MiniMed 640G system.
DSS second quarter revenue was flat on a constant currency basis. In the U.S., consumables benefited from installed base growth and improved patient utilization, which was offset by price declines and increased payer requirements. In international markets, the Diabeter business had mid-twenties patient growth, while in consumables, installed base growth was offset by temporary market pressures in China and France.
NDT second quarter revenue declined in the high-twenties on a constant currency basis given the temporarily limited supply of sensors for professional CGM. However, the division had 60 percent new account growth in US primary care.
Guidance

Medtronic today reiterated its revenue and non-GAAP EPS guidance. The company’s guidance is given on a comparable, constant currency basis, which accounts for the divestiture of certain businesses from its prior period Patient Monitoring & Recovery division by removing the financial impact of these businesses from the second, third, and fourth quarters of fiscal year 2017, as well as removing the impact of foreign currency.

In fiscal year 2018, the company continues to expect comparable, constant currency revenue growth to be in the range of 4 to 5 percent. While the impact of foreign currency remains fluid, if current exchange rates remain similar for the remainder of the fiscal year, the company’s revenue would be positively affected by approximately $275 million to $375 million for the fiscal year, including an approximate $155 to $175 million positive impact in the third fiscal quarter.

In fiscal year 2018, the company continues to expect diluted non-GAAP EPS growth to be in the range of 9 to 10 percent on a comparable, constant currency basis from the prior year comparable EPS of $4.37. Assuming current exchange rates remain similar for the rest of the year, the foreign exchange impact on the company’s non-GAAP EPS would be approximately negative 2 cents for the fiscal year, including an approximate positive 1 cent impact in the third fiscal quarter.

"We are seeing increased revenue momentum from several important new product launches, which we expect to continue into the second half of the fiscal year," said Ishrak. "The combination of our growth momentum, business and geographic diversification, as well as our scale in markets around the world contribute to our goal of delivering increasingly consistent and dependable results for our shareholders."

Webcast Information

Medtronic will host a webcast today, November 21, at 8:00 a.m. EST (7:00 a.m. CST) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on our Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules

To view the second quarter financial schedules and non-GAAP reconciliations, click here. To view the second quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.

On November 21, 2017 Celgene Corporation (NASDAQ: CELG) reported that it plans to webcast an analyst and investor event being held at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in Atlanta on December 10 (Press release, Celgene, NOV 21, 2017, View Source [SID1234522188]). The webcast will begin at 8pm ET and will be available in the Investor Relations section of the Company’s website at www.celgene.com.

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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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