Archive for March, 2017
Aurinia Pharmaceuticals Inc., (NASDAQ:AUPH)(TSX:AUP) today announced that its Chief Executive Officer, Richard M. Glickman, will present at the Cowen and Company 37th Annual Healthcare Conference in Boston, MA on March 6, 2017 at 1:20pm ET. A webcast will be available and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay will also be archived on the site following the event.
About Aurinia
Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of lupus nephritis (LN), an inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE) and represents a serious progression of SLE. The company is headquartered in Victoria, BC and focuses its development efforts globally. www.auriniapharma.com.
We Seek Safe Harbor.
Aurinia Pharmaceuticals Inc.
Investor & Media Contact:
Celia Economides
Head of IR & Communications
ceconomides@auriniapharma.com
WEST PALM BEACH, FL–(March 02, 2017) – Rennova Health, Inc. (NASDAQ: RNVA) (NASDAQ: RNVAZ) (“Rennova” or the “Company”), a vertically integrated provider of industry-leading diagnostics and supportive software solutions to healthcare providers, announced today that the recently re-named Big South Fork Medical Center in Oneida, Tenn. has received nearly 200 job applications within hours of opening its online portal to facilitate the hiring of new staff.
“We continue to believe we are on schedule to reopen this hospital in the second quarter, and look forward to the provision of a needed service to the community,” said Joseph Herrod, who is leading the hospital division for Rennova. “Where possible, we will hire people from the local community and initial applications indicate that many previous employees are looking forward to getting their jobs back. The hospital will employ approximately 130 people in full operation,” concluded Mr. Herrod.
Big South Fork Medical Center is classified as a Critical Access Hospital (rural), with 25 beds, a 24/7 emergency department, operating rooms and a laboratory that provides a range of ancillary diagnostic services. The facility includes a 52,000-sq. ft. hospital building and a 6,300 sq. ft. professional building on approximately 4.3 acres. The hospital enjoys numerous in-network contracts with payers that the Company believes will ensure predictable and reliable payment for services. The hospital had unaudited annual revenues of approximately $12 million, and a normalized EBITDA of approximately $1.3 million for fiscal 2015, the last full year of the hospital’s operation
The Company is pleased to announce that its diagnostics division continues to successfully expand its footprint as a participating provider with multiple Insurance payers. We have now increased the number of states within which we hold Medicaid licenses to 30, and the number of payer contracts it holds, both state and national, to 24. This includes a recent success with one of the largest insurance providers by market share.
“We believe our accomplishments and timeline to reopen the hospital in Oneida and continued accomplishments in our overall business are in keeping with our strategy and business plan,” said Seamus Lagan, CEO of Rennova Health. “We look forward to a strong recovery in 2017 after a very difficult 2016, and we anticipate filing our 2016 audit timely by March 31st and updating our shareholders and investors at that time.”
About Rennova Health, Inc.
Rennova provides industry-leading diagnostics and supportive software solutions to healthcare providers, delivering an efficient, effective patient experience and superior clinical outcomes. Through an ever-expanding group of strategic brands that work in unison to empower customers, we are creating the next generation of healthcare. For more information, please visit www.rennovahealth.com.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Actual results may differ from expectations and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Additional information concerning these and other risk factors are contained in the Company’s most recent filings with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or any change in events, conditions or circumstances on which any such statement is based, except as required by law.
HERNANDO, FL–(Mar 2, 2017) – National Waste Management Holdings, Inc. (OTC: NWMH) (“National Waste”), a growing and emerging vertically integrated solid waste management company, today announces that it has acquired Burts Refuse LLC, continuing its commitment to completing one acquisition per quarter.
Burts Refuse is a waste disposal and recycling business located in West Davenport, New York. The acquisition of the company, which closed February 28, 2016, increases National Waste’s territory for commercial and residential garbage collection in Upstate New York, as well as expands its roll-off customer base and business relationships. Additionally, the acquired trucks, equipment and containers fortify National Waste’s existing line of equipment.
“We are pleased to demonstrate to shareholders our ability to execute an aggressive acquisition strategy,” says Louis “Tiny” Paveglio, CEO of National Waste Management. “This approach exemplifies the hard work of our team to identify and pursue acquisition targets that supplement our existing operations while facilitating additional growth.”
The transaction is a direct tuck-in of operations in which National Waste will not absorb the overhead of Burts Refuse, allowing for expected EBITDA numbers in the 45 percent range of carved-out operations.
About National Waste Management Holdings Inc.
National Waste Management Holdings Inc. is a growing and emerging vertically integrated solid waste management company with a concentration on C&D collection, hauling and recycling. National Waste services Florida’s west coast and upstate New York and is a distinguished leader in solid waste services. More information may be found at the Company’s website: http://www.nationalwastemgmt.com.
This release contains certain statements that are, or may be deemed to be, forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934, and are made in reliance upon the protections provided by such Acts for forward-looking statements. We have identified forward-looking statements by using words such as “expect,” “believe,” and “should.” Although we believe our expectations are reasonable, our operations involve a number of risks and uncertainties that are beyond our control, and these statements may turn out not to be true. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company’s Form SEC filings.
Liberty Interactive Corporation (Nasdaq: QVCA, QVCB, LVNTA, LVNTB) announced that Michael George, President and CEO of QVC, Inc., will be presenting at the UBS Global Consumer & Retail Conference on Wednesday, March 8th at 3:15 p.m., E.S.T. at the Four Seasons in Boston, MA. During his presentation, Mr. George may make observations regarding the company’s financial performance and outlook.
The presentation will be broadcast live via the Internet. All interested persons should visit the Liberty Interactive Corporation website at http://www.libertyinteractive.com/events to register for the webcast. An archive of the webcast will also be available on this website for one year after appropriate filings have been made with the SEC.
About Liberty Interactive Corporation
Liberty Interactive Corporation operates and owns interests in a broad range of digital commerce businesses. Those businesses are currently attributed to two tracking stock groups: the QVC Group and the Liberty Ventures Group. The businesses and assets attributed to the QVC Group (Nasdaq: QVCA, QVCB) consist of Liberty Interactive Corporation’s subsidiaries, QVC, Inc. and zulily, llc, and its interest in HSN, Inc., and the businesses and assets attributed to the Liberty Ventures Group (Nasdaq: LVNTA, LVNTB) consist of all of Liberty Interactive Corporation’s businesses and assets other than those attributed to the QVC Group, including its interests in Liberty Broadband Corporation and FTD, Liberty Interactive Corporation’s subsidiary Evite, and minority interests in Interval Leisure Group, Lending Tree and Charter Communications.
Liberty Interactive Corporation
Courtnee Chun, 720-875-5420
AUSTIN, Texas, March 1, 2017 — ASPiRA LABs, a Vermillion company (NASDAQ: VRML), today announced a major contracted agreement with Blue Cross Blue Shield of Michigan for ASPiRA’s U.S. FDA cleared, American College of Obstetricians and Gynecologists (ACOG) recommended ovarian cancer risk assessment test, OVA1 (MIA). Blue Cross Blue Shield of Michigan serves over six million beneficiaries throughout Michigan and surrounding states.
“We are pleased to announce our Blue Cross Blue Shield of Michigan agreement for OVA1 (MIA),” said Valerie Palmieri, President and CEO of Vermillion, Inc. “We continue to execute on our managed care strategy, which has direct impact on access for women in Michigan and the surrounding states. Michigan and the Great Lakes area is a target market for ASPiRA.”
“Days and weeks matter with ovarian cancer. The mortality rate of ovarian cancer has not changed in 40 years, even following the introduction of CA125. Two thirds of women today with ovarian cancer do not receive the initial appropriate treatment. Now that ACOG has included OVA1 (MIA) in their guidelines for the Evaluation and Management of Adnexal Masses,1 and the FDA clarified in December 2016 that its Ovarian Cancer Screening safety warning did not apply to OVA1 (MIA)/Overa (MIA2G), we believe Vermillion is well positioned to continue to expand coverage and increase access to our technologies, and ensure optimal care for all patients.”
See website to review clinical studies showing OVA1’s (MIA’s) strong performance over CA125:
http://vermillion.com/providers/ova-1/clinical-validation-studies/
About Vermillion
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, discovers, develops and delivers innovative diagnostic and technology tools that help women with serious diseases. The company’s initial in vitro diagnostic test, OVA1® (MIA), was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, and represented a new class of software-based liquid biopsy in vitro diagnostics. In March 2016, Vermillion received FDA clearance for Overa™, a second generation OVA1 (MIA2G) test with significantly improved specificity and ease of use. For additional information, including published clinical trials, visit www.vermillion.com.
About OVA1® (MIA) and Overa™ (MIA2G)
- OVA1 (MIA) is a proprietary FDA-cleared blood test designed to help physicians assess the risk of ovarian cancer prior to surgery, facilitating more effective referral of high risk patients to a specialist (gynecologic oncologist) for surgical treatment.
- OVA1 (MIA) now has an ACOG Level B recommendation for the Evaluation and Management of Adnexal Masses (ACOG Practice Bulletin #174, November 2016).
- The OvaCalc® proprietary algorithm combines five biomarker results into a single numerical “risk score” that stratifies patients into “higher risk” and “lower risk” when combined with clinical assessment.
- In two pivotal clinical trials, OVA1 (MIA) plus clinical assessment (ca) detected 94% of all malignancies vs. only 77% for CA125 plus ca,2 and OVA1 (MIA) plus ca detected 95.3% of all malignancies vs. only 80% for CA125 plus ca.3
- In a study focused on early-stage ovarian cancer detection, 31% of cases were missed by clinical impression alone. This was reduced to 5% when OVA1 (MIA) was added to clinical impression, a reduction of 85%.4
- Overa (MIA2G) measures the levels of five proteins found in the blood and then uses a second-generation OvaCalc® algorithm to stratify risk. A woman’s risk of cancer is measured by using a 0-10 scale with a single cut-off point of 5 eliminating the ambiguity in determining menopausal status. A high Overa score is not a diagnosis of cancer, rather it indicates an increased risk of malignancy when used as intended.
- OVA1 (MIA) has shown clinical utility in increasing the rate of referrals of malignant adnexal masses to gynecologic oncologists. The increased involvement of specialists may lead to increased adherence to National Comprehensive Cancer Network guidelines which includes surgical treatment by a gynecologic oncologist, which is associated with improved cancer outcomes, including overall survival. In a study focused on specialist involvement in ovarian cancer treatment, 94% of patients with an elevated-risk OVA1 (MIA) result who had primary ovarian malignancies were appropriately referred to a gynecologic oncologist.5
- PRECAUTION: OVA1® and Overa tests should not be used without an independent clinical/radiological evaluation and are not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of OVA1® or Overa carries the risk of unnecessary testing, surgery and/or delayed diagnosis.
Forward-Looking Statements
This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995 that involve significant risks and uncertainties including statements regarding Vermillion’s position to expand coverage for OVA1 (MIA). Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained in this press release are based on Vermillion’s expectations as of the date of this press release. A variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements, including changes to interpretations of existing laws and regulations and other factors that are described in Vermillion’s Form 10-K for the year ended December 31, 2015 and Form 10-Q for the quarter ended March 31, 2016 as filed with the Securities and Exchange Commission. Vermillion expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.
Investor Relations Contact:
Michael Wood
LifeSci Advisors LLC
Tel 1-646-597-6983
1 American College of Obstetricians and Gynecologists. ACOG Practice Bulletin #174. Evaluation and Management of Adnexal Masses. Obstet Gynecol. 2016; 128:e210-26.
2 Ware Miller R, Smith A, DeSimone CP, Seamon L, Goodrich S, Podzielinski I, et al. Performance of the American College of Obstetricians and Gynecologists’ ovarian tumor referral guidelines with an index assay. Obstet Gynecol 2011 Jun; 117(6):1298-306.
3 Longoria TC, Ueland FR, Zhang Z, Chan DW, Smith A, Fung ET, et al. Clinical performance of a multivariate index assay for detecting early-stage ovarian cancer. Am J Obstet Gynecol 2014 Jan; 210(1):78.e1-9.
4 Bristow RE, Smith A, Zhang Z, Chan DW, Crutcher G, Fung ET, et al. Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay. Gynecol Oncol 2013 Feb; 128(2):252-9.
5 Eskander RN, Carpenter BA, Wu HG, Wolf JK. The clinical utility of an elevated-risk multivariate index assay score in ovarian cancer patients. Curr Med Res Opin 2016 Jun; 32(6):1161-5.
– Trial 006 demonstrated a statistically significant and clinically meaningful reduction in OFF-time and increase in proportion of patients “ON” by 8:00 am (primary and key secondary endpoints) –
– The trial also showed statistically significant reduction in troublesome dyskinesia and a complete reduction of OFF-time to zero hours in 66% of responders (post hoc sub-groups analyses) –
– Company to host conference call and webcast today at 8:30 a.m. ET-
REHOVOT, Israel, March 01, 2017 — NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical company developing drug-device combinations for central nervous system (CNS) disorders, today announced that a preliminary analysis of trial 006 demonstrated that the trial successfully met its primary, key secondary and additional secondary endpoints. Trial 006 was an international open label, blinded rater, phase II study of ND0612H, NeuroDerm’s high dose continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation, in patients with advanced Parkinson’s disease.
NeuroDerm also announced that it has modified its EU clinical and regulatory development strategy following a meeting with the European Medicines Agency (EMA). The modified strategy will be based on NeuroDerm’s restarted and amended iNDiGO phase III efficacy study (trial 007), rather than on bioequivalent pharmacokinetic (PK) studies. Based on discussions with the EMA, NeuroDerm believes that this strategy should allow it to pursue a broader EU label, with no effect on its clinical and regulatory timelines.
“The very prominent responder effect, as well as the significant reductions in OFF-time and troublesome dyskinesia observed in trial 006, are extremely encouraging and demonstrate the substantial potential for ND0612 to make a meaningful difference in the lives of patients living with Parkinson’s disease,” said Oded S. Lieberman, PhD, CEO of NeuroDerm. “We believe that restarting and amending the iNDiGO trial, incorporating both an ND0612H arm and new endpoints that reflect these very positive preliminary results from trial 006, should support a broader label in the EU and increase the clinical and commercial potential of ND0612 while not affecting our clinical timelines. We are committed to improving the lives of Parkinson’s patients by achieving our clinical and regulatory objectives as quickly as possible and providing Parkinson’s disease patients with a safer and more effective alternative to current treatment options.”
Trial 006 Endpoints
The primary endpoint of this study was to assess the change from baseline to day 28 in daily OFF-time (normalized to 16 waking hours) as assessed by a blinded rater. A key secondary endpoint was to assess the percentage of subjects who were “ON” by 8:00am and 9:00am. Additional secondary endpoints were also evaluated as well as safety and tolerability.
Trial 006 Design
Trial 006 was a 28-day multicenter, international (US, EU and Israel), parallel-group, blinded rater, randomized phase II study that investigated the efficacy, safety, tolerability and pharmacokinetics of two dosing regimens (R1 and R2) of ND0612H and compared them to the baseline of standard optimized oral therapy:
- R1: 24 hour administration of ND0612H (720/90mg LD/CD) at a high day rate for 18 hours and a low night rate for 6 hours.
- R2: 14 hour administration of ND0612H during the waking hours (538/68mg LD/CD) complemented by a morning dose of 150/15mg oral LD/CD.
All patients could add oral LD/CD therapy at any time as needed. The trial enrolled 38 patients with advanced Parkinson’s disease.
Trial 006 Preliminary Results
The 38 enrolled subjects had typical characteristics for patients with advanced Parkinson’s disease including: an average age of 63.5 years, 11.5 years since diagnosis and an average baseline OFF-time of 5.3 hours per day.
OFF-time (primary endpoint):
The primary endpoint was met in R1. From 5.5 hours at baseline, the OFF-time was reduced by 2.8 hours (p equals 0.004). There was a smaller, non-statistically significant reduction of 1.3 hours in OFF-time in R2.
“ON” by 8:00am and 9:00am (key secondary endpoint):
In R1, the proportion of patients who achieved the first “ON” by 8:00am (as reported by the patient) increased from 11% at baseline to 50% by day 28 (p equals 0.020), and, by 9:00am, from 26% at baseline to 75% (p equals 0.004). In R2, dosing began in the morning and there was therefore no improvement from baseline at either timepoint.
Complete reduction of OFF-time (post-hoc analysis):
In R1, 42% of patients had a complete reduction in OFF-time to zero hours (in R2, 11% experienced complete resolution of OFF-time). Patients who experienced reduction in OFF-time (greater than 0 hours change) during the trial were defined as “Responders” and constituted 68% of all patients (12 patients in R1 and 14 patients in R2). Eight (66%) of the Responders in R1 (and two (14%) of the Responders in R2) experienced a complete reduction of their OFF-time to zero hours; all Responders in R1 experienced a reduction of more than 50% in their OFF-time.
“Good” ON (secondary endpoint):
Good ON (defined as “ON” with no or mild dyskinesia, as assessed by the blinded rater) increased in R1 from 9.2 hours by 3.7 hours (p less than 0.001), and in R2 from 8.5 hours by 2.8 hours (p equals 0.003).
Unified Parkinson’s Disease Rating Scale (UPDRS) III by 8:00am (post-hoc analysis):
UPDRS III score by 8:00am decreased in R1 from 37.4 at baseline by 19.1 points (p less than 0.001) and from 37.3 at baseline by 10.7 points in R2 (p equals 0.001).
Troublesome Dyskinesia (post hoc analysis):
Troublesome dyskinesia (defined as “ON” with moderate or severe dyskinesia as assessed by the blinded rater) decreased from 5.1 hours at baseline by 3.5 hours (p equals 0.011) in the subgroup of all patients who had at least 1 hour of troublesome dyskinesia at baseline (N equals 14, R1 and R2 combined).
Oral LD Dosing and Frequency (post hoc analysis):
Average dosing frequency of oral levodopa decreased in all patients from 6.6 times at baseline to 2.3 times per day by day 28. The average dose of oral LD decreased from approximately1100mg at baseline to approximately 330mg.
Safety and Tolerability:
33 subjects (87%) out of 38 completed the study with 5 who did not complete the study, two of which were due to adverse events: one due to an infection at the infusion site and the other due to worsening of symptoms. Infusion site reactions (nodules, bruising and erythema) were common yet generally well tolerated. These results corroborate the safety and tolerability data obtained in previous studies and did not raise new safety or tolerability concerns.
Preliminary Results:
Preliminary trial 006 results demonstrate that the R1 dosing regimen provides a significant reduction in OFF-time and a significant increase in ON-time with no or mild dyskinesia. A substantial percentage of subjects experienced complete resolution of OFF-time. The treatment was associated with some nodules, consistent with prior trials, but otherwise did not raise new safety or tolerability concerns. Benefits were also seen with the R2 regimen in spite of the study design whereby patients started levodopa therapy later in the morning. ND0612H devices were generally found to be reliable with only few minor, correctable malfunctions reported. No inconvenience related to the wearing of the device was reported for either day or night administration.
Detailed trial results will be presented at a future medical meeting.
ND0612 EU Clinical and Regulatory Development
NeuroDerm recently received minutes from a meeting held in January 2017 with the EMA’s Scientific Advice Working Party. Based on this meeting and on the preliminary results of trial 006, NeuroDerm has modified its EU clinical and regulatory development path. Upon completion of its ongoing trials, NeuroDerm plans to submit a marketing application based on the results of an amended iNDiGO phase III efficacy study and the ongoing BeyoND (trial 012) long-term safety trial, seeking to obtain a broader label for ND0612 than the label that could have been granted under a PK regulatory route in the EU. The previously planned PK trial (trial 009) will not be carried out. Anticipated timelines for submission of the EU marketing application remain unchanged. NeuroDerm’s U.S. clinical and regulatory development timelines also remain unchanged.
iNDiGO Trial
NeuroDerm’s iNDiGO phase III efficacy study (trial 007) will be restarted and amended to support a broad label claim in the EU for ND0612. The trial will be expanded from 150 to 240 patients by adding a third treatment arm of ND0612H to the current ND0612L and control arms. Furthermore, new endpoints that reflect the recent trial 006 results, including a responder analysis, will be incorporated into this trial. NeuroDerm believes that these should enable the company to seek approval for both the low- and high-dose versions of ND0612 in the EU. It is anticipated that iNDiGO will be completed in 2018, in parallel to the ongoing long term BeyoND safety trial (Trial 012).
Conference Call Details
NeuroDerm will host a conference call at 8:30 a.m. ET today. Individuals can access the webcast in the Events and Presentations section of the Company’s website, by clicking here, or by dialing 844-452-2810 (U.S.) or 574-990-9831 (outside of the U.S.). The passcode is 79280228. A webcast will be archived on the website.
About ND0612
ND0612 is designed to significantly reduce motor complications in Parkinson’s disease patients through continuous, subcutaneous delivery of LD/CD solution. Previously completed Phase II trials demonstrated that the low dose ND0612L maintained steady, therapeutic levodopa plasma concentrations that were associated with major changes in several clinical parameters including “OFF” time reductions when added to optimal oral standard of care. The high dose ND0612H, intended for severe Parkinson’s disease patients, was shown to reach even higher levodopa steady plasma levels, indicating that it may provide an effective therapy alternative to current treatments requiring surgery such as deep brain stimulation and LD/CD Intestinal Gel.
About Parkinson’s disease
Parkinson’s disease is a progressive neurodegenerative illness characterized by reduced dopamine in the brain, resulting in a debilitating decrease in the patient’s motor and non-motor functions. Its symptoms, such as trembling in the extremities and face, slowness of movement and impaired balance and coordination, worsen over time and gravely impact the patient’s quality of life. Levodopa is the most effective treatment for Parkinson’s disease. However, chronic oral levodopa treatment is associated with fluctuations in motor response as result of which, despite the benefits of the drug, patients can experience periods of impaired motor and non-motor functions, also referred to as “OFF” time. In addition, mainly as a result of excessive/intermittent oral doses of levodopa aimed at treating the “OFF” time, some patients experience involuntary movements, or dyskinesia. The “OFF” time and dyskinesia affect the majority of levodopa-treated Parkinson’s disease patients and can interfere with day-to-day functions, causing patients to become severely disabled. Current evidence suggests that intermittent dosing with standard oral formulations of levodopa contributes to the development of these motor complications. By contrast, it has been shown that continuous administration of levodopa can effectively treat motor fluctuations in Parkinson’s disease patients without increasing troublesome dyskinesia; however, a convenient route for continuous administration has not been introduced to date.
About NeuroDerm
NeuroDerm is a clinical-stage pharmaceutical company developing drug-device combinations for central nervous system (CNS) disorders that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration. NeuroDerm has three product candidates in different stages of development which offer a solution for almost every Parkinson’s disease patient from the moderate to the very severe stage of the disease. NeuroDerm has developed a line of levodopa and carbidopa (LD/CD) product candidates administered through small belt pumps that deliver a continuous, controlled dose of LD/CD. The LD/CD product candidates are ND0612L and ND0612H, which are used for treatment of moderate and advanced Parkinson’s disease patients, respectively, and which are delivered subcutaneously. In addition, NeuroDerm is developing ND0701, a novel subcutaneously delivered apomorphine formulation for patients who suffer from moderate to severe Parkinson’s disease and who do not respond well to LD/CD. NeuroDerm is headquartered in the Weizmann Science Park in Rehovot, Israel.
Forward-Looking Statements
This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties. Such forward-looking statements may include projections regarding our future performance and may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “seek” and similar terms or phrases. The forward-looking statements contained in this press release are based on management’s current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the risks provided under “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2015 filed with the Securities and Exchange Commission. Any forward-looking statement made by us in this press release speaks only as of the date hereof. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
NeuroDerm Contact:
Oded S. Lieberman, PhD, CEO
oded@neuroderm.com
Tel.: +972-8-946 2729; Cell: +1-617-517 6077
U.S. Investor Contact:
David Carey
Lazar Partners Ltd.
dcarey@lazarpartners.com
+212-867-1768
U.S. Media Contact:
Erich Sandoval
Lazar Partners Ltd.
esandoval@lazarpartners.com
+917-497-2867
SOUTH SAN FRANCISCO, Calif., March 01, 2017 — Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, today announced its participation at the Cowen and Company 37th Annual Health Care Conference 2017. Susan M. Molineaux, Ph.D., the company’s Founder, President and Chief Executive Officer, will present on Wednesday, March 8, 2017, at 10:00 a.m. Eastern Time in Boston, Massachusetts. The presentation will be webcast live and available for replay for up to 30 days at www.calithera.com in the Investor Relations section.
About Calithera
Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839 takes advantage of the pronounced dependency many cancers have on the nutrient glutamine for growth and survival. It is currently being evaluated in Phase 1/2 clinical trials in combination with standard of care agents. CB-1158 is a first-in-class immuno-oncology metabolic checkpoint inhibitor targeting arginase, a critical immunosuppressive enzyme responsible for T-cell suppression by myeloid-derived suppressor cells. Arginase depletes arginine, a nutrient that is critical for the activation, growth and survival of the body’s cancer-fighting immune cells, known as cytotoxic T-cells. CB-1158 is currently in a Phase I clinical trial. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “poised” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the Company’s clinical pipeline of novel cancer therapies. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price. Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, and other periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

Contact:
Jennifer McNealey
ir@Calithera.com
650-870-1071
MINNEAPOLIS, March 01, 2017 — Skyline Medical Inc. (NASDAQ:SKLN) (“Skyline” or “the Company”),producer of the FDA-approved STREAMWAY® System for automated, direct-to-drain medical fluid disposal has received an Innovative Technology contract from Vizient, Inc. With an annual purchasing volume of almost $100 billion, Vizient is the largest, member-driven health care performance improvement company in the country. The contract was based on a recommendation of STREAMWAY by hospital experts with expertise in this category who serve on one of Vizient’s member-led councils. Innovative Technology contracts are reserved for technologies that demonstrate an ability to enhance clinical care or patient safety, and those that improve an organization’s care delivery and business model.
“We are delighted that STREAMWAY has been awarded the Innovative Technology contract, which will provide new avenues to reach member organizations as potential customers for STREAMWAY,” said Dr. Carl Schwartz, chief executive officer of Skyline Medical. “We also are honored that the system has been recognized by Vizient for its innovation. The award is the culmination of more than a year’s work for Skyline, beginning with a presentation and subsequent participation in Vizient’s Summit. The award has permitted STREAMWAY to be added to Vizient’s contracts outside of its competitive bidding cycle.”
“Due to the number of products and services being released and marketed as ‘innovative’, member hospitals truly value the peer-review system in place at Vizient to help them identify products worth further evaluation at their own facilities,” said Debbie Archer, director of procurement and leader of Vizient’s Innovative Technology program for suppliers. “After a review of the STREAMWAY® System, Vizient’s member council agreed this solution offers unique and incremental benefit over other products available on the market today, and recommended it for an Innovative Technology designation.”
Vizient, Inc. represents the combined strengths of the organizations formerly known as VHA Inc., University HealthSystem Consortium, Novation and MedAssets’ Spend and Clinical Resource Management. Since 2003, nearly 2200 new and innovative products and technologies have been submitted through the Vizient Innovative Technology program. Vizient works with member-led councils and task forces to identify and review potentially innovative products. If it is determined that a product is innovative, a contract may be awarded outside of Vizient’s competitive bid cycle.
About the STREAMWAY System
Skyline’s revolutionary, FDA-cleared STREAMWAY system is the first true direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures. It connects directly to a facility’s plumbing system to automate the collection, measurement and disposal of waste fluids. As of September 30, 2016, Skyline Medical customers have installed 96 STREAMWAY systems in 50 facilities across 19 states.
The STREAMWAY minimizes human intervention for better safety and improves compliance with Occupational Safety and Health Administration (OSHA) and other regulatory agency safety guidelines. It also provides unlimited capacity for increased efficiency in the operating room, which leads to greater profitability. Furthermore, the STREAMWAY eliminates canisters to reduce overhead costs and provides greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the U.S. For a demonstration please visit www.skylinemedical.com or call 855-785-8855.
About Skyline Medical
Skyline Medical produces a fully automated, patented, FDA-cleared waste fluid disposal system that virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods that require hand carrying and emptying filled fluid canisters present an exposure risk and potential liability. Skyline Medical’s STREAMWAY System fully automates the collection, measurement and disposal of waste fluids and is designed to: 1) reduce overhead costs to hospitals and surgical centers; 2) improve compliance with OSHA and other regulatory agency safety guidelines; 3) improve efficiency in the operating room, and radiology and endoscopy departments, thereby leading to greater profitability; and 4) provide greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills each year in the U.S. For additional information, please visit www.skylinemedical.com.
Forward-looking Statements
Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company’s business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable, adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company’s ability to implement its long range business plan for various applications of its technology, including the possibility that the development of applicable technologies by GLG Pharma, LLC will be delayed, will not occur or will not receive applicable regulatory approvals on a timely basis; the Company’s ability to consummate its joint venture with Electronic On-Ramp, Inc.; the Company’s ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, which are available for review at www.sec.gov. This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company’s financial position. See the Company’s most recent Annual Report on Form 10-K, and subsequent reports and other filings at www.sec.gov.

Contact:
Investors
LHA
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com
WESTON, FL–(Mar 1, 2017) – Monaker Group, Inc (OTCQB: MKGI), a technology-driven travel company focused on the alternative lodging rental (ALR) market, has been invited to present at 29th Annual ROTH Conference being held on March 13-15, 2017 at The Ritz-Carlton in Dana Point, California.
Monaker Chairman and CEO Bill Kerby is scheduled to present on Wednesday, March 15 at noon Pacific time. He will be joined by the company’s CFO, Omar Jimenez, and director of corporate development, Richard Marshall for one-on-one meetings with institutional analysts and investors held throughout the conference.
Management will discuss the company’s launch of the industry’s first real-time’ alternative lodging reservation system that includes mainstream travel products and service — all on a single site.
The presentation will be webcast live and available for replay at http://wsw.com/webcast/roth31/mkgi and via the News & Events section of the company’s website at www.monakergroup.com.
This year’s ROTH Conference will feature presentations from hundreds of growth companies, along with Q&A sessions, expert panels, and thousands of one-on-one and small group meetings. As one of the largest of its kind, the event is designed to provide investors with a unique opportunity to gain insight into emerging growth companies across a variety of industry sectors.
For more information about the conference or to schedule a one-on-one meeting with Monaker, please contact your ROTH representative at (800) 678-9147 or via e-mail at oneononerequests@roth.com.
About ROTH Capital Partners
ROTH Capital Partners, LLC is a relationship-driven investment bank focused on serving emerging growth companies and their investors. As a full-service investment bank, ROTH provides capital raising, M&A advisory, analytical research, trading, market-making services and corporate access. Headquartered in Newport Beach, CA, ROTH is privately-held and employee owned, and maintains offices throughout the U.S. For more information on ROTH, please visit www.roth.com.
About Monaker
Monaker Group, Inc. is a technology driven travel company with several divisions and brands that build upon more than 65 years of operational experience in leisure travel. Monaker’s flagship NextTrip website is powered by the industry’s first real-time booking engine that offers extensive choices in alternative lodging (vacation home rentals, resort residences and unused timeshares) along with a vast array of airlines, hotels, cruises, rental cars, tours and concierge services, all in a single platform. The site features rich content, imagery and high-quality video that enhances a traveler’s booking experience and assists them in the search, decision and purchasing process. By combining key features and functionality with advanced technology and established travel brands, NextTrip offers comprehensive vacation alternatives at best-pricing. For more information, visit www.monakergroup.com or www.nexttrip.com.
Safe Harbor Statement
This press release contains forward-looking statements that involve risks and uncertainties concerning the plans and expectations of Monaker Group. These statements are only predictions and actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties, some of which are out of our control. The potential risks and uncertainties include, among others, or the expectations of future growth may not be realized. These forward-looking statements are made only as of the date hereof, and Monaker Group undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise. All forward looking statements are expressly qualified in their entirety by the “Risk Factors” and other cautionary statements included in Monaker Group’s annual, quarterly and special reports, proxy statements and other public filings with the Securities and Exchange Commission (“SEC”), including, but not limited to, the Company’s Annual Report on Form 10-K for the period ended February 29, 2016 which has been filed with the SEC and is available at the SEC’s website at www.sec.gov.
Monaker Group Contact:
Richard Marshall
Director of Corporate Development
Monaker Group
Tel: (954) 888-9779
rmarshall@monakergroup.com
Investor Relations Contact:
Ronald Both or Grant Stude
CMA
Tel: (949) 432-7557
rb@cma.bz