$VYGR Positive Interim Results, Phase 1b #VYAADC01 in #Parkinson’s

VY-AADC01 dose-dependently improved measures of motor function and enhanced response to levodopa at six and twelve months; administration of VY-AADC01 was well-tolerated

Program on track to report Cohort 3 data mid-2017 and to begin placebo-controlled trial Q4:17

Conference call scheduled for today at 4:30 p.m. EST

CAMBRIDGE, Mass., Dec. 07, 2016  — Voyager Therapeutics, Inc. (NASDAQ:VYGR), a clinical-stage gene therapy company developing life-changing treatments for severe diseases of the central nervous system (CNS), today announced positive results from the ongoing Phase 1b trial of VY-AADC01 at six and twelve months of follow-up in patients with advanced Parkinson’s disease.  The interim data from Cohorts 1 and 2 of this trial demonstrated that accurate MRI-guided delivery of escalating doses of VY-AADC01 were well tolerated and resulted in increased coverage of the putamen, increased AADC enzyme activity, enhanced response to levodopa, and dose-related, clinically meaningful improvements in various measures of patients’ motor function.  This was especially evident at the higher dose in Cohort 2 with improved UPDRS off medication and on medication scores, and corresponding improvements in patient-reported diary hours, suggesting higher peak effects and a longer duration of action of levodopa.  These effects were maintained and in some patients improved at 12 months of follow-up.

“At 12 months in Cohort 2, treatment with VY-AADC01 resulted in a 14-point, or 44%, improvement in UPDRS-III off medication, a 9-point, or 55% improvement in UPDRS-III on medication, and a 2.2 hour, or 48%, decrease in diary off-time from baseline,” said Bernard Ravina, M.D., M.S., vice president of clinical development at Voyager Therapeutics.  “Very importantly, these improvements in motor function occurred with a substantial 34% reduction in daily doses of oral levodopa and related medications at six months in Cohort 2 that was maintained at 12 months, a magnitude that we find compelling and consistent with the mechanism of action of VY-AADC01.  The dose-escalating portion of this trial continues and we plan to complete Cohort 3 enrollment in early 2017, report 6-month data from this Cohort as well as longer-term data from Cohorts 1 and 2 in mid-2017, and present results from this trial at a medical conference in the first half of next year.”

About the Phase 1b Trial

In advanced Parkinson’s disease, the putamen is depleted of dopamine and of the enzyme aromatic L-amino acid decarboxylase (AADC) that is responsible for converting levodopa to dopamine.  VY-AADC01 is Voyager’s gene therapy vector that contains the gene that encodes the AADC enzyme.  The Phase 1b, open-label trial includes up to 20 patients with advanced Parkinson’s disease and disabling motor fluctuations, treated with a single administration of VY-AADC01.  The primary objective of the trial is to assess the safety and surgical coverage of ascending doses of VY-AADC01 in the putamen, a region of the brain associated with motor function in Parkinson’s disease.  The secondary objectives of the trial include the assessment of AADC expression and activity in the putamen measured by positron emission tomography (PET) using [¹⁸F] fluorodopa (or ¹⁸F-DOPA).  In addition, changes in motor responses to levodopa are measured by a controlled intravenous infusion of levodopa and by measuring daily requirements for levodopa and related medications.  Other secondary objectives include assessment of motor function as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS) and a patient-completed (Hauser) diary.

The UPDRS is a standard clinical rating scale for Parkinson’s disease.  Part III of this scale measures motor function by physician examination. The UPDRS is conducted when patients are taking their Parkinson’s disease medications (referred to as “on” medication) and when patients are not taking their Parkinson’s disease medications (referred to as “off” medication).  In the patient-completed diary, patients record their motor response over the course of several days as on-time, or time when they have good mobility with or without non-troublesome dyskinesia, off-time when they have poor mobility, and on-time with troublesome dyskinesia when they have uncontrolled movements.

Biomarker and Clinical Results Summary

Today’s interim results include data from all 10 patients treated in Cohorts 1 and 2 at six months (five patients in each Cohort), and where indicated, data from five patients in Cohort 1 and three patients in Cohort 2 who have reached 12 months of follow-up.  Patients in Cohorts 1 and 2 received a single administration of VY-AADC01 at a total dose of up to 7.5×10¹¹ vector genomes (vg) and 1.5×10¹² vg, respectively.  Patients enrolled in Cohorts 1 and 2 were on average 58 years of age with a Parkinson’s disease diagnosis for an average of 10 years.  Patients were candidates for surgical intervention due to disabling motor complications despite treatment with optimal anti-Parkinsonian medication.  At baseline, the average UPDRS III off medication score was 37.2 and 35.8, and the average patient diary off-time was 4.9 and 4.2 hours, for Cohort 1 and 2, respectively.  Patients’ average amount of Parkinson’s disease medications at baseline was 1,468 mg per day for Cohort 1 and 1,636 mg per day for Cohort 2.  The results below are reported as mean changes from baseline to six months, or 12 months where indicated.

Putamen Coverage and Biomarker Data

• The use of real-time, intra-operative MRI-guided delivery and increasing infusion volumes resulted in 21% coverage of the volume of the putamen with VY-AADC01 in Cohort 1 and 34% coverage in Cohort 2.
• VY-AADC01 treatment resulted in a 13% increase in putaminal AADC enzyme activity in Cohort 1 and a 56% increase in putaminal AADC enzyme activity in Cohort 2 at six months relative to baseline as measured by ¹⁸F-DOPA PET scans.
• Patients reduced their daily oral dose of levodopa and related medications by 14% in Cohort 1 and 34% in Cohort 2 at six months.  This reduction in oral medication was generally maintained at twelve months.
• VY-AADC01 treatment prolonged the duration and markedly increased the motor symptom response to levodopa measured following a controlled intravenous infusion of levodopa administered six months after surgery when compared to baseline.

Clinical Data Summary

Treatment with VY-AADC01 resulted in the following:

• 15.6-point and 17.8-point (42% and 50%) improvement (reduction) in UPDRS-III off medication at six months in Cohort 1 and Cohort 2, respectively.  These improvements were 16.4-point and 14.3-point (44% and 44%) for Cohorts 1 and 2, respectively, at 12 months.
• 9.6-point (56%) improvement (reduction) in UPDRS-III on medication in Cohort 2 at six months that was sustained at 12 months.  Cohort 1 demonstrated a 1.6-point (21%) worsening (increase) at six months that was sustained at 12 months.
• 2.2 hours (20%) increase in diary on-time (with no dyskinesias or non-troublesome dyskinesias) in Cohort 2 at six months that further increased to 4.1 hours (43%) at 12 months.  Cohort 1 showed a slight decrease in on-time at six months of 0.3 hours (-3%) and an increase of 1.6 hours (16%) at 12 months.
• 1.1 hour (27%) decrease in diary off-time in Cohort 2 at six months that further decreased to 2.2 hours (48%) at 12 months.  Decreases in diary off-time in Cohort 2 also occurred in conjunction with a reduction in troublesome dyskinesias.  Cohort 1 showed a decrease in diary off-time of 0.8 hours (16%) at six months and 1.4 hours (27%) at 12 months.

Safety Data from Cohorts 1 and 2

The surgical procedure was successfully completed in all 10 patients and infusions of VY-AADC01 have been well-tolerated with no vector-related serious adverse events (SAEs).  Nine of the 10 patients were discharged from the hospital within one to two days following surgery.  As previously reported, one patient experienced two SAEs; a pulmonary embolism or blood clot in the lungs, and related heart arrhythmia or irregular heartbeat.  The patient was treated with an anti-coagulant and symptoms associated with the SAEs have completely resolved.  Investigators determined that this was most likely related to immobility during the surgical procedure and subsequent formation of a blood clot, or deep vein thrombosis (DVT), in the lower extremity.  Consequently, DVT prophylaxis was added to the surgical protocol and no subsequent events have been observed following implementation of these measures.

“Our surgical experience with VY-AADC01 and the results to date show that MRI-guided infusions are well tolerated and substantially improve our ability to tailor the infusions to fit the patients’ anatomy and accurately deliver vector to the putamen,” said Paul Larson, M.D., Professor and Vice Chair of Clinical Neurological Surgery, University of California San Francisco, and investigator in the trial.  “The increased surgical coverage of the putamen is further validated by the PET data and is translating into motor function improvement in patients with advanced stages of the disease.”

Todd Sherer, Ph.D., Chief Executive Officer, The Michael J. Fox Foundation for Parkinson’s Research added, “Levodopa has been the gold-standard treatment for Parkinson’s for decades, but it has limitations.  Enhancing a patient’s response to this therapy represents an important development for those who suffer from the advanced stages of this disease, and we are glad to see the continued progress of this program.”  The Michael J. Fox Foundation funded part of the initial pioneering research for this program in Dr. Krystof Bankiewicz’s laboratory at the University of California San Francisco.

Cohort 3 and Posterior Trajectory Trial On Track

To advance the planned dose-escalating portion of the trial, Voyager continues to enroll patients in Cohort 3 (up to five patients) who will receive a single administration of VY-AADC01 at a total dose of up to 4.5×10¹² vector genomes (vg), representing a three-fold higher total dose than patients in Cohort 2 (1.5 × 10¹² vg).  To date, four of five patients have been treated in Cohort 3 and Voyager plans to complete Cohort 3 enrollment in early 2017 and remains on track to report six-month data in mid-2017.  In preparation for the randomized, placebo-controlled trial, Voyager also plans to initiate a new trial that could enhance the efficiency of the surgical delivery and further increase both coverage and total vector dose.  This trial will employ a posterior (i.e., back of the head), or occipital, trajectory which aligns the infusion of VY-AADC01 with the anatomical structure of the putamen. Voyager believes this will result in a higher total volume of coverage of the putamen and therefore a higher total dose (up to 9.4×10¹² vg, representing a two-fold higher total dose than patients in Cohort 3) and may reduce surgical times.  Voyager is activating additional clinical trial sites this quarter and plans to dose the first patient with this trajectory in the first quarter of 2017.  Data from Cohorts 1-3 and from this posterior trajectory trial will inform the design of the placebo-controlled trial planned to begin in the fourth quarter of 2017.

Conference Call and Webcast Information

Voyager will host a conference call and webcast today with slides at 4:30 p.m. EST to discuss the results.  The conference call may be accessed by dialing (877) 851-3834 for domestic callers or +1 (631) 291-4595 for international callers, and referencing conference ID number 32331935.  A live audio webcast of the conference call and replay will be available online from the Investors & Media section of Voyager’s website at www.voyagertherapeutics.com.  The webcast will be archived for 30 days.

About Parkinson’s Disease and VY-AADC01

Parkinson’s disease is a chronic, progressive and debilitating neurodegenerative disease that affects approximately 700,000 people in the U.S.¹ and seven to 10 million people worldwide².  It is estimated that up to 15% of the prevalent population with Parkinson’s disease, or approximately 100,000 patients in the U.S., have motor fluctuations that are refractory, or not well-controlled, with levodopa.  While the underlying cause of Parkinson’s disease in most patients is unknown, the motor symptoms of the disease arise from a loss of neurons in the midbrain that produce the neurotransmitter dopamine.  Declining levels of dopamine in this particular region of the brain leads to the motor symptoms associated with Parkinson’s disease including tremors, slow movement or loss of movement, rigidity, and postural instability.  Motor symptoms during the advanced stages of the disease include falling, gait freezing, and difficulty with speech and swallowing, with patients often requiring the daily assistance of a caregiver.

There are currently no therapies that effectively slow or reverse the progression of Parkinson’s disease.  Levodopa remains the standard of care treatment, with its beneficial effects on symptom control having been discovered over 40 years ago³.  Patients are generally well-controlled with oral levodopa in the early stages of the disease, but become less responsive to treatment as the disease progresses.  Patients experience longer periods of reduced mobility and stiffness termed off-time, or the time when medication is no longer providing benefit, and shorter periods of on-time when their medication is effective.

The progressive motor symptoms of Parkinson’s disease are largely due to the death of dopamine neurons in the substantia nigra, a part of the midbrain that converts levodopa to dopamine, in a single step catalyzed by the aromatic L-amino acid decarboxylase (AADC) enzyme.  Neurons in the substantia nigra release dopamine into the putamen where the receptors for dopamine reside.  In advanced Parkinson’s disease, neurons in the substantia nigra degenerate and the enzyme AADC is markedly reduced in the putamen, which limits the brain’s ability to convert oral levodopa to dopamine⁴.  The neurons in the putamen do not degenerate in Parkinson’s disease^5,6.  VY-AADC01, comprised of the adeno-associated virus-2 capsid and a cytomegalovirus promoter to drive AADC transgene expression, is designed to deliver the AADC gene directly into the putamen where the dopamine receptors are located, bypassing the substantia nigra neurons and enabling the neurons of the putamen to express the AADC enzyme to convert levodopa into dopamine.  The approach with VY-AADC01, therefore, has the potential to durably enhance the conversion of levodopa to dopamine and provide clinically meaningful improvements in motor symptoms following a single administration.

About Voyager Therapeutics

Voyager Therapeutics is a clinical-stage gene therapy company developing life-changing treatments for severe diseases of the CNS.  Voyager is committed to advancing the field of adeno-associated virus (AAV) gene therapy through innovation and investment in vector engineering and optimization, manufacturing and dosing and delivery techniques.  The Company’s pipeline focuses on severe CNS diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of ALS, Friedreich’s ataxia, Huntington’s disease, frontotemporal dementia, Alzheimer’s disease and severe, chronic pain.  Voyager has broad strategic collaborations with Sanofi Genzyme, the specialty care global business unit of Sanofi, and the University of Massachusetts Medical School.  Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager Therapeutics is headquartered in Cambridge, Massachusetts.  For more information, please visit www.voyagertherapeutics.com.  Follow Voyager on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities law. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements.  For example, all statements Voyager makes regarding the initiation, timing, progress and reporting of results of its preclinical programs and clinical trials and its research and development programs, its ability to advance its AAV-based gene therapies into, and successfully complete, clinical trials, its ability to continue to develop its product engine, its ability to add new programs to its pipeline, its expected cash, cash equivalents and marketable securities at the end of a fiscal year and anticipation for how long expected cash, cash equivalents and marketable securities will last, and the timing or likelihood of its regulatory filings and approvals, are forward looking.  All forward-looking statements are based on estimates and assumptions by Voyager’s management that, although Voyager believes to be reasonable, are inherently uncertain.  All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected.  These statements are also subject to a number of material risks and uncertainties that are described in Voyager’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as updated by its future filings with the Securities and Exchange Commission.  Any forward-looking statement speaks only as of the date on which it was made.  Voyager undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

¹ Willis et al, Neuroepidemiology.2010;34:143–151

² www.pdf.org/en/parkinson_statistics

³ Poewe W, et al, Clinical Interventions in Aging.2010;5:229-238.

⁴ Lloyd, J Pharmacol Exp Ther. 1975;195:453-464, Nagatsu, J Neural Transm Suppl.2007

⁵ Cold Spring Harb Perspect Med 2012;2:a009258

⁶ Braak et al, Cell Tissue Res.2004;318:121-134

Investor Relations:	
Matt Osborne
Head of Investor Relations & Corporate Communications
857-259-5353
mosborne@vygr.com   

Media:	
Katie Engleman
Pure Communications, Inc.
910-509-3977
Katie@purecommunicationsinc.com

$ANTH Positive Data for #BRIGHTSC in #IgANephropathy Study

• Lower proteinuria in blisibimod versus placebo treated patients
• Changes in circulating B-cells and serum immunoglobulins consistent with BAFF inhibition

HAYWARD, Calif., Dec. 06, 2016  — Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced positive trends from the Week 48 analysis of the Phase 2 BRIGHT-SC proof-of-concept study in 57 patients with IgA nephropathy.

The effects of blisibimod versus placebo were assessed through at least the 48 week time point in all patients in the BRIGHT-SC study.   Patients enrolled in the BRIGHT-SC study had biopsy-proven IgA nephropathy with a mean proteinuria level of 2.4 grams and an estimated glomerular filtration rate of less than 70 mL/min/1.73m² – indicative of stage 2 chronic kidney disease per the National Kidney Foundation.  Patients were on background angiotensin converting enzyme inhibitors or receptor blockers, but corticosteroids were not permitted during the trial.

A positive trend on proteinuria of blisibimod in patients with biopsy-proven IgA nephropathy was observed. Consistent with the previously announced Week 24 analysis, blisibimod treated-patients over time demonstrated stable to slightly decreasing levels of estimated 24 hour urinary protein excretion, as assessed by urinary protein to creatinine ratio (PCR), as compared to slowly increasing levels of proteinuria in the placebo group. 44 of the original 57 patients had a Week 48 observation and 22 patients had a Week 96 observation at the time of this analysis.

Total B cell counts and serum immunoglobulins IgA, IgG, and IgM, continued to demonstrate marked reduction, consistent with data from the Week 24 analysis as well as other studies with blisibimod.

No safety or tolerability concerns were observed with blisibimod during routine reviews of the unblinded trial data by the study’s independent Data and Safety Monitoring Board.

“The sustained effects of blisibimod versus placebo on proteinuria after up to 2 years of treatment are very encouraging for IgA nephropathy patients, for whom no treatments exist,” said Jonathan Barratt, MD, Reader in the Department of Infection, Immunity & Inflammation, University of Leicester, Honorary Consultant Nephrologist at Leicester General Hospital, and Head of the Postgraduate Specialty School of Clinical Academic Training at Health Education East Midlands. “We look forward to receiving longer term data from the study which will provide more conclusive assessment of blisibimod on the progression of kidney disease.”

“The Week 48 observations from the BRIGHT-SC study continue to demonstrate consistent pharmacological effects on B cells and serum immunoglobulins, and suggest an effect on proteinuria,” said William Shanahan, MD, Anthera’s Chief Medical Officer. “We believe proteinuria is a robust surrogate biomarker for IgA nephropathy disease activity, and we remain optimistic that a longer-term evaluation in greater numbers of patients could provide further validation of blisibimod’s effects on IgA nephropathy by demonstrating continuing effects on proteinuria and preservation of glomerular function.”

The full dataset from this study will be submitted and presented at an upcoming scientific conference.

About BRIGHT-SC

The study enrolled 57 patients, 44 of whom completed assessments through a minimum of 48 weeks. Patients with persistent proteinuria (1-6 g/24hrs) prior to enrollment were randomized to receive either blisibimod (300mg/wk for 8 weeks and 200mg/wk thereafter) or matching placebo over background angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) for up to 104 weeks and are followed thereafter in the absence of study drug to assess longer term outcome. All patients were treated with an optimal dose of ACEi or ARB for a minimum of 90 days prior to randomization and this therapy was continued throughout the trial as background medication for all patients. Steroid intervention was not permitted during the trial.

The BRIGHT-SC study was originally designed as a phase 2/3 study with a target enrollment of 200 patients with renal biopsy verified IgA nephropathy, 24 hour urine protein excretion of 1-6 grams by urinary protein to creatinine ratio (PCR), and an estimated glomerular filtration rate (eGFR) of more than 30 ml/min/1.73 m² of body surface area.  The original primary endpoint of the study was the number of patients who achieved a partial or complete response in urinary protein excretion at Week 24. A partial response is defined as achieving proteinuria ≤1g/24hrs, and a complete response as follows: for patients with baseline proteinuria ≥1g/24hrs but ≤2g/24hrs, achievement of proteinuria ≤1.0g/24hr AND a 50% reduction from baseline at 2 consecutive visits; for patients with baseline proteinuria >2g/24hrs, achievement of proteinuria ≤1.0g/24hr OR a 50% reduction from baseline at 2 consecutive visits. Due to slow recruitment, enrollment was curtailed at 57 and the study was converted to phase 2. An observed case analysis was conducted when all patients had the opportunity to complete Week 24 and topline results were previously announced.  Based upon the Week 24 results, applications for Orphan Drug and Breakthrough Status have been filed with the FDA, with responses expected by late 1Q2017.

About IgA Nephropathy

IgA nephropathy (IgAN, also known as Berger’s disease) is the most common cause of primary glomerulonephritis worldwide, occurring more frequently in Asia than in Europe or North America. Patients express under-glycosylated immunoglobulin A1 (IgA1) which is immunogenic and targeted by other immunoglobulins.  The resulting IgA-containing immune complexes are deposited in the kidney, causing inflammation with consequent blood and protein leakage into the urine. The disease typically progresses slowly, but as many as 40-50% of adults will eventually develop end-stage-renal disease and require dialysis or kidney transplant. The current management of IgAN is non-specific treatment aimed at blood pressure control and reduction of proteinuria with angiotensin converting enzyme inhibitors (ACEI) and/or angiotensin II receptor blockers (ARBs); corticosteroids and immunosuppressive therapy are used in some patients but benefits are uncertain.

About Anthera Pharmaceuticals, Inc.

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious and life-threatening diseases, including lupus, lupus with glomerulonephritis, IgA nephropathy, and exocrine pancreatic insufficiency due to cystic fibrosis. Additional information on the Company can be found at www.anthera.com.

Safe Harbor Statement

Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as “estimate,” “intend,” “anticipate,” “believe,” “plan,” “goal,” “expect,” “project,” or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera’s expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera’s public filings with the SEC, including Anthera’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

Contact Information:

Nikhil Agarwal of Anthera Pharmaceuticals, Inc.,
nagarwal@anthera.com or 510.856.5600 x5621

$PLAY Promotes #MargoManning to #COO, #SeniorVP

DALLAS, Dec. 06, 2016  — Dave & Buster’s Entertainment, Inc., (NASDAQ:PLAY), (“Dave & Buster’s” or “the “Company”), an owner and operator of entertainment and dining venues, today announced the promotion of Margo Manning to Chief Operating Officer and Senior Vice President.

Ms. Manning had previously served as Senior Vice President of Human Resources since November 2010. Prior to that, she was our Senior Vice President of Training and Special Events from September 2006 until November 2010, our Vice President of Training and Sales from June 2005 until September 2006 and our Vice President of Management Development from September 2001 until June 2005. From December 1999 until September 2001, she was our Assistant Vice President of Team Development, and from 1991 until December 1999, she served in various positions of increasing responsibility for us and our predecessors.

“I sincerely appreciate the confidence placed in me by the executive leadership and board and am honored to accept this promotion. For the last 25 years, I have been fortunate to work at such a dynamic company and to be surrounded by a dedicated team who are so passionate about strengthening our brand positioning as a ‘one of a kind’ entertainment and dining destination. While we have certainly accomplished a great deal in appealing to our targeted demographics, growing Dave & Buster’s to more than 90 stores, and generating nearly $1 billion in annual revenue, I believe that we have an even brighter future. I intend to do my part as Chief Operating Officer to see that our brand drives results, delivers shareholder value, and achieves its full potential,” said Ms. Manning.

“Margo has always been a stellar performer who brings an infectious level of energy and excitement to everything that she does. We congratulate her on this well-deserved promotion,” said Steve King, Chief Executive Officer.

The Company also announced the resignation of Dolf Berle, former President and Chief Operating Officer. Mr. Berle is expected to announce his decision to accept a position with another company shortly.

“We’d like to thank Dolf for his many contributions over the last years and wish him our very best,” added King.

About Dave & Buster’s Entertainment, Inc.

Founded in 1982 and headquartered in Dallas, Texas, Dave & Buster’s Entertainment, Inc., is the owner and operator of 91 venues in North America that combine entertainment and dining and offer customers the opportunity to “Eat, Drink, Play and Watch,” all in one location.  Dave & Buster’s offers a full menu of “Fun American New Gourmet” entrées and appetizers, a full selection of alcoholic and non-alcoholic beverages, and an extensive assortment of entertainment attractions centered around playing games and watching live sports and other televised events.  Dave & Buster’s currently has stores in 33 states and Canada.

For Investor Relations Inquiries:
Arvind Bhatia, CFA
Dave & Buster’s Entertainment, Inc.
214.904.2202
arvind_bhatia@daveandbusters.com

$ONTX and #Cellworks Announce #MDS Presentation for 2016 ASH

Computational Subgroup Analysis of Phase 3 ONTIME Trial Provides Insights into Clinical Response to Rigosertib in Higher-risk MDS

CONTACT: Onconova Therapeutics

Benjamin Hoffman, 267-759-3036

bhoffman@onconova.us

CONTACT: Cellworks

Taher Abbasi, 408-467-3805

taher@cellworksgroup.com

$VKTX Receives #OrphanDrug Designation for #VK0214 in #Adrenoleukodystrophy

– Orphan Drug Designation program provides development and regulatory benefits to medications intended for the safe and effective treatment, diagnosis or prevention of rare diseases – VK0214 is a novel, selective thyroid receptor β agonist that stimulates the expression of genes believed to be relevant to the manifestation of X-ALD

SAN DIEGO, Dec. 6, 2016  — Viking Therapeutics, Inc. (“Viking”) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to VK0214 for the treatment of X-linked adrenoleukodystrophy (X-ALD).  VK0214 is a novel, orally available thyroid receptor beta (TRβ) agonist that selectively regulates the expression of genes believed to be relevant to the manifestation of X-ALD.

VK0214 is currently being evaluated in preclinical models of X-ALD under a sponsored research agreement with the Kennedy Krieger Institute.  Data to date have demonstrated promising in vivo activity, including significant reductions in plasma very long chain fatty acids (VLCFA), important biochemical markers of disease.

“Viking is committed to evaluating the potential of VK0214 for the treatment of X-ALD, a devastating and progressively debilitating disease for which there is no approved therapy.  Our research indicates that VK0214 positively impacts key genes and biomarkers that may affect the onset of X-ALD, which suggests potential therapeutic benefits in this setting,” said Brian Lian, Ph.D., chief executive officer of Viking Therapeutics.  “The Orphan Drug designation underscores the importance of new therapies in areas of high unmet medical need, such as X-ALD, and we look forward to the continued advancement of VK0214 for this underserved disease.”

X-ALD is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells; a process known as demyelination.  The disease, for which there is no approved treatment, is caused by mutations in a peroxisomal transporter of VLCFAs, known as ABCD1.  As a result, transporter function is impaired and patients are unable to efficiently metabolize VLCFA.  The resulting accumulation can trigger a rapid, inflammatory demyelination, which leads to cognitive impairment, motor skill deterioration, and even death.  X-ALD is estimated to occur in approximately 1 in 17,000 births.

FDA’s Orphan Drug Designation program provides certain incentives for companies developing therapeutics to treat rare diseases or conditions, defined as those affecting less than 200,000 individuals in the U.S.  A drug candidate and its sponsor must meet several key criteria in order to qualify for, and obtain, orphan drug status.  Once a drug has received orphan drug designation, the developer qualifies for a range of benefits, including federal grants, tax credits, reduction in certain regulatory fees, and the potential for seven years of market exclusivity for the drug following FDA marketing approval.

About VK0214
VK0214 is a novel, orally available thyroid receptor beta (TRβ) agonist that selectively modulates lipoprotein and triglyceride levels in liver tissue.  This mechanism has been demonstrated to affect the expression of the genes that are relevant to the manifestation of X-ALD.  In X-ALD, mutations in the ABCD1 gene lead to the accumulation of very long-chain fatty acids (VLCFAs) which is believed to be a fundamental cause of the disease.  Research has shown that increasing the expression of the ABCD2 gene can counteract this process and lead to normalization of VLCFA levels.  In preclinical studies, VK0214 has been shown to induce expression of ABCD2 by increasing TRβ activity, leading to the belief that it may provide therapeutic benefit to X-ALD patients.

About X-ALD
X-ALD is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells; a process known as demyelination.  The disease, for which there is no approved treatment, is caused by mutations in a peroxisomal transporter of VLCFAs, known as ABCD1.  As a result, transporter function is impaired and patients are unable to efficiently metabolize VLCFA.  The resulting accumulation can trigger a rapid, inflammatory demyelination, which leads to cognitive impairment, motor skill deterioration, and even death.  X-ALD is estimated to occur in approximately 1 in 17,000 births.

The thyroid beta receptor is known to regulate expression of an alternative VLCFA transporter, known as ABCD2.  Various preclinical models have demonstrated that increased expression of ABCD2 can lead to normalization of VLCFA metabolism.

About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders.  The company’s research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients’ lives.  Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.  The company’s clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, in Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist in Phase 2 development for hypercholesterolemia and fatty liver disease, and VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes.  Viking is also developing novel and selective agonists of the thyroid beta receptor for adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.

Follow Viking on Twitter @Viking_VKTX.

Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, including statements about Viking’s expectations regarding its development activities, timelines and milestones, as well as the company’s goals and plans regarding VK0214. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking’s product candidate development activities and clinical trials; and risks regarding regulatory requirements, among others. These forward-looking statements speak only as of the date hereof.  Viking disclaims any obligation to update these forward-looking statements.

$NVCN Provides Update on its #Tiara #MitralValve Clinical Program

-Recent results presented at the ICI Meeting in Israel-

NASDAQ: NVCN
TSX: NVC

VANCOUVER, Dec. 6, 2016  – Neovasc Inc. (“Neovasc” or the “Company“) (NASDAQ: NVCN) (TSX: NVC) today provided an update on the clinical experience with its Tiara™ transcatheter mitral valve.  Tiara™ is a novel transcatheter device designed to treat mitral regurgitation (MR), a condition that is often severe and can lead to heart failure and death.

To date, 22 patients have been treated with the Tiara™ valve at medical centers in Canada, the U.S. and Europe with more implantations scheduled for the coming weeks.  The technical success rate in these implantations was 19/22 or 86%.  In these technically successful implantations, paravalvular leak levels were reported as mild, trace or absent in 100% of these cases.  All cause 30-day mortality in the 19 patients who have reached 30 days post implant with Tiara™ is 15.7% (3/19).  The 3 remaining patients treated within the last 30 days are recovering well.  Of note, there has been no 30-day mortality reported in any of the last 8 patients treated over a month ago.

To date, the longest patient follow up available is nearing 3 years post implant, where the Tiara™ valve remains fully functional. There have been no reported adverse events related to the valve performance.  There have been no frame fractures, or any device performance issues observed with the Tiara™ in any patient follow-up.

The results noted above were presented today by Dr. Shmuel Banai, at the ICI Meeting 2016 (ICI) in Tel Aviv, Israel.  ICI is the premier International Conference for Innovations in Cardiovascular Systems.

Tiara has demonstrated the ability to treat a range of different patient anatomies, including patients with pre-existing prosthetic aortic valves (both mechanical and biological) and those with prior mitral repair surgery including mitral rings, which may be contra indications for other devices.

“Tiara’s unique shape and trigonal tab anchoring system enables the device to be securely implanted with reduced risk of projecting into the LVOT or potentially interfering with prosthetic aortic valves which are commonly present in this patient population,” stated Alexei Marko, Neovasc CEO. “Furthermore, the Tiara anchoring system does not rely significantly on the integrity of the native mitral leaflets and therefore can be suitable for certain degenerative MR patients with flail leaflets or calcification.  It has also been successfully shown that the design of Tiara makes it suitable for certain cases where mitral rings have been previously implanted in patients.”

TIARA II, a 115 patient, non-randomized, prospective clinical study evaluating Tiara’s safety and performance, recently received approval to begin enrolling patients in Italy.  It is expected that data from this study will be used to file for CE Mark approval for Tiara™.  CE Mark is the European Union (EU) regulatory approval to commercialize a medical device. It is anticipated  that the first implantations in the TIARA II trial will be conducted by the medical team at San Raffaele Hospital in Milan, Italy in the first quarter of 2017.  The Company will be initiating additional investigational sites in 2017 as required approvals are obtained.

About Tiara™
Tiara™ is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the U.S. with a similar number of patients effected throughout Europe.  Tiara™ is implanted in the heart using a minimally invasive, transapical transcatheter approach and is designed to replace the diseased native mitral valve without the need for open-heart surgery or use of a cardiac bypass machine.

About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace.  Its products include the Neovasc Reducer™, for the treatment of refractory angina which is not currently available in the U.S. and has been available in Europe since 2015 and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under investigation in the US, Canada and Europe. The Company also sells a line of advanced biological tissue products that are used as key components in third-party medical products including transcatheter heart valves. For more information, visit: www.neovasc.com.

This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws relating to the the potential for contra indications of Tiara for other devices, the suitability of the Tiara anchoring system for certain degenerative MR patients with flail leaflets or calcification and the Company’s plans and expectations concerning the TIARA II clinical study in Italy, including the Company’s expectation that data from the TIARA II clinical study in Italy will be used to file for CE Mark approval for Tiara, the anticipated location and timing of the implantations in the TIARA II trial and the expected initiation of additional investigational sites in 2017.The words “expected”, “will”, “anticipated”, “look forward”, “may”, “can” and similar words or expressions are intended to identify forward-looking statements.  Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate in the circumstances.  Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the conduct or possible outcomes of any actual or threatened legal proceedings; the Company’s ability to stay the payment of the awards in the CardiAQ litigation and its ability to successfully appeal the validity of the awards as well as the ruling on inventorship, which are inherently uncertain andwhich create material uncertainty and cast substantial doubt on the Company’s ability to continue as a going concern; the potential impact on the Company’s business of an adverse decision in the appeal on the question of inventorship even if the Company prevails on its appeal of the awards; potential changes in circumstances relating to the Company’s financing requirements, whether as a result of the CardiAQ litigation, unforeseen circumstances or otherwise; the Company’s ability to raise additional funding;  the potential benefits of the Neovasc Reducer™ and Tiara™ as compared with other products; successful enrollment of patients in studies and trials for the Neovasc Reducer™ and Tiara™; results of the trials and studies for the Neovasc Reducer™ and Tiara™ that meet the Company’s expectations; the Company’s receipt of any required local and institutional regulatory approvals and the timing and costs of obtaining such approvals; European enrollment in our clinical trials, studies and compassionate use cases and the success of applications in Europe; the Company’s ability to protect its intellectual property; changes in business strategy or development plans; existing governmental regulations and changes in, or the failure to comply with, governmental regulations and general economic and business conditions, both nationally and in the regions in which the Company operates. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form, which is included in its Annual Report on Form 40-F and Management’s Discussion and Analysis of Financial Condition and Results of Operation (copies of which filings may be obtained at www.sedar.com or www.sec.gov).  These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements.  The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

$MKGI Tip of the #Travel Industry Iceberg — SECFilings.com

$XXII Overview of #MMJ, Industrial #Hemp at this Year’s at the #LDMicro Conference

22nd Century Group, Inc. (NYSE MKT: XXII), a leader in tobacco harm reduction and cannabis research, announced today that the Company will present at the LD Micro Invitational Investor Conference at the Luxe Sunset Boulevard Hotel, 11461 Sunset Boulevard, Los Angeles, California, on Wednesday, December 7, 2016 at 1:30 p.m. EST.

Henry Sicignano, III, President and Chief Executive Officer, and Dr. Paul Rushton, Vice President of Plant Biotechnology, will provide investor attendees with a business update and will highlight 22nd Century’s advances in the rapidly evolving legal medical marijuana and industrial hemp markets. Headlining the presentation will be Dr. Rushton’s discussion of the Company’s proprietary cannabis initiatives, including the development of THC-free industrial hemp varieties and the propagation of medical marijuana strains that are selected for increased levels of medically-important cannabinoids, such as CBC and CBD. Both Mr. Sicignano and Dr. Rushton will be available for one-on-one meetings at the conference.

Dr. Rushton explained, “We are delighted that our research and development is opening exciting new paths to medically-important and industrially-important products. We are developing new medical marijuana as well as industrial hemp varieties with substantially altered levels of cannabinoids, all of which will be below the legal limit of 0.3% THC. We aim to become major suppliers of proprietary plants for both legal medical marijuana and industrial hemp cultivation, which are projected to be multi-billion dollar markets in the near term. The Company is actively filing provisional patents in these fields. We are also expanding our activities in an increasing number of pilot hemp projects with research universities possessing all necessary federal and state licenses and permits. These are exciting times indeed.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants through genetic engineering and plant breeding. The Company’s primary mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 200 issued patents and more than 50 pending patent applications around the world. For more information, visit www.xxiicentury.com and www.botanicalgenetics.com.

Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2015, filed on February 18, 2016, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.

$SELB Secures Licensing Agreement with $ONCE

Exclusive use of Selecta’s Synthetic Vaccine Particles (SVP™) platform technology provided to Spark Therapeutics for co-administration with up to five gene therapy targets, including FVIII for hemophilia A

SVP may enhance gene therapies by enabling repeat dosing and mitigating other potential immune responses to an AAV capsid

PHILADELPHIA and WATERTOWN, Mass., Dec. 05, 2016  — Spark Therapeutics (NASDAQ:ONCE) and Selecta Biosciences, Inc. (NASDAQ:SELB) today announced a license agreement that provides Spark Therapeutics with exclusive worldwide rights to Selecta’s proprietary Synthetic Vaccine Particles (SVP™) platform technology for co-administration with gene therapy targets, including FVIII for hemophilia A, as well as exclusive options for up to four additional undisclosed genetic targets.

Selecta’s immune tolerance SVP, including SVP-Rapamycin, is an investigational technology intended to suppress the formation of neutralizing antibodies to an adeno-associated virus (AAV) capsid when used in combination with gene therapies, without altering the therapeutic profile of the gene therapy. Neutralizing antibodies form in response to an initial administration of an AAV gene therapy and prevent effective subsequent usage. The potential ability to re-dose a gene therapy may be beneficial where a patient has not achieved a sufficient therapeutic expression of the transferred gene in the initial dose.

“Selecta’s nanoparticle technology, which is undergoing preclinical testing in gene therapy, may prevent formation of neutralizing antibodies, and thus potentially enable re-dosing up to an optimal therapeutic profile by extending the reach of gene therapy to diseases that require higher doses or more extensive transduction of target cells than may be achieved through one-time dosing,” said Jeffrey D. Marrazzo, chief executive officer of Spark Therapeutics. “Importantly, if proven successful, the co-administration of Selecta’s technology with a gene therapy may enable repeat dosing of AAV gene therapies in both adults and pediatric patients, potentially minimizing the risk of a T-cell immune response to the capsid.”

“Gene therapy is a core area of focus for Selecta; one that we believe could benefit profoundly from our immune tolerance SVP technology platform,” said Werner Cautreels, Ph.D., president, CEO and chairman of Selecta. “We are excited about this license agreement with Spark Therapeutics, a recognized gene therapy leader, which accelerates the application of our SVP platform in gene therapy. Our preclinical studies in this field, together with the clinical data we have generated with SEL-212 in gout showing prevention of anti-drug antibodies, suggest that the application of our immune tolerance SVP technology to biologic therapies may greatly benefit patients with life-threatening diseases who currently lack adequate treatment options due to the occurrence of undesired immune responses.”

Subject to the terms of the agreement, Spark Therapeutics will make an initial $10 million cash payment to Selecta and purchase $5 million of Selecta’s common stock. Within 12 months of the agreement’s signing, Spark Therapeutics has agreed to pay Selecta an additional $5 million in cash and to purchase $10 million of Selecta’s common stock. Selecta will be eligible for up to $430 million in milestone payments for each target, with up to $65 million being based on Spark Therapeutics’ achievement of specified development and regulatory milestones and up to $365 million for specified commercial milestones. In addition, Spark Therapeutics will pay Selecta tiered mid-single to low-double-digit royalties on worldwide annual net sales of any resulting commercialized gene therapy.

The terms of this agreement do not apply to Spark Therapeutics’ ongoing investigational development programs in inherited retinal diseases (IRDs), including voretigene neparvovec for the treatment of RPE65-mediated IRD and SPK-7001 for choroideremia. This agreement does not impact Spark Therapeutics’ ongoing Phase 1/2 trial of SPK-9001 in hemophilia B in collaboration with Pfizer or its planned Phase 1/2 trial of SPK-8011 in hemophilia A.

Selecta independently is applying its SVP technology to its own proprietary gene therapy programs. Selecta has obtained an exclusive license from Massachusetts Eye and Ear to Anc80, an in silico-designed gene therapy vector, for Methylmalonic Acidemia and has options for additional pre-defined indications. Additionally, Selecta is advancing a proprietary gene therapy program for Ornithine Transcarbamylase Deficiency.

About Spark Therapeutics
Spark Therapeutics, a fully integrated company, is striving to challenge the inevitability of genetic disease by discovering, developing, and delivering gene therapies that address inherited retinal diseases (IRDs), liver-mediated diseases such as hemophilia, and neurodegenerative diseases. Our validated platform successfully has delivered proof-of-concept data with investigational gene therapies in the retina and liver. Our most advanced investigational candidate, voretigene neparvovec, in development for the treatment of RPE65-mediated IRD, has received orphan designations in the U.S. and European Union, and breakthrough therapy designation in the U.S. The pipeline also includes SPK-7001, in a Phase 1/2 trial for choroideremia, and two hemophilia development programs: SPK-9001 in a Phase 1/2 trial for hemophilia B being developed in collaboration with Pfizer (which also has received both breakthrough therapy and orphan product designations) and SPK-8011, a preclinical candidate for hemophilia A to which Spark Therapeutics retains global commercialization rights. To learn more about us and our growing pipeline, visit www.sparktx.com.

Spark Cautionary Note on Forward-looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the company’s SPK-FIX program. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the SVP nanoparticle technology used in connection with gene therapies will not produce results in humans that are similar to the preclinical results observed to date. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in our Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and other filings we make with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Spark undertakes no duty to update this information unless required by law.

About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company developing targeted therapies that use immunomodulators encapsulated in nanoparticles to induce antigen-specific immune responses to prevent and treat disease. Selecta’s proprietary Synthetic Vaccine Particles (SVP™) technology is a highly flexible nanoparticle platform capable of incorporating a wide range of antigens and immunomodulators, allowing SVP-based products to either induce antigen-specific tolerance or activate the immune system. Selecta’s focus and strategy is to leverage its SVP immune modulating platform to develop and commercialize highly differentiated life-sustaining biologic drugs that are uniquely capable of mitigating the formation of anti-drug antibodies (ADAs). Proprietary programs that use SVP-Rapamycin to enhance efficacy and safety of therapy include SEL-212, Selecta’s lead Phase 2 clinical program in chronic refractory gout, and two gene therapies programs for genetic metabolic diseases. Tolerance-inducing SVP biological products also have potential applications in the treatment of allergies and autoimmune diseases. Selecta is also developing SVP product candidates that activate the immune system to prevent and treat cancer, infections and other diseases. Selecta is based in Watertown, Massachusetts, USA. For more information, please visit http://selectabio.com.

Selecta Biosciences Forward-looking Statements
Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, statements regarding the company’s expectation about receiving payments from Spark Therapeutics under the license agreement, the progress of the Phase 1/2 clinical program of SEL-212 including the number of centers in the Phase 2 clinical trial of SEL-212 and the announcement of data, conference presentations, the ability of the company’s SVP platform, including SVP-Rapamycin, to mitigate immune response and create better therapeutic outcomes, the potential treatment applications for products utilizing the SVP platform including repeat dosing for gene therapy, any future development of the company’s discovery programs in peanut allergy and celiac disease, the sufficiency of the company’s cash, cash equivalents, investments, and restricted cash and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, the unproven approach of the company’s SVP technology, potential delays in enrollment of patients, undesirable side effects of the company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the company’s inability to maintain its existing or future collaborations or licenses, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, substantial fluctuation in the price of its common stock, a significant portion of the company’s total outstanding shares are eligible to be sold into the market in the near future, and other important factors discussed in the “Risk Factors” section of the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 10, 2016, and in other filings that the company makes with the SEC. In addition, any forward-looking statements included in this press release represent the company’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Spark Therapeutics Corporate Contact:
Daniel Faga, Chief Business Officer
(855) SPARKTX (1-855-772-7589)

Spark Therapeutics Media Contact:
Dan Quinn
Ten Bridge Communications
(781) 475-7974
dan@tenbridgecommunications.com

Selecta Biosciences Contact:
Jason Fredette
617-231-8078
jfredette@selectabio.com

$TXMD #VMS Indication #TX001HR Positive Top-Line Results, Phase 3

TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced positive top-line results from its pivotal phase 3 Replenish Trial of TX-001HR, an investigational bio-identical hormone therapy combination of 17ß-estradiol and progesterone in a single, oral softgel, for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause in post-menopausal women with an intact uterus.

The Replenish Trial evaluated four doses of TX-001HR and placebo in 1,835 post-menopausal women between 40 and 65 years old. The doses studied were:

• 17ß-estradiol 1 mg/progesterone 100 mg (n = 416)
• 17ß-estradiol 0.5 mg/progesterone 100 mg (n = 423)
• 17ß-estradiol 0.5 mg/progesterone 50 mg (n = 421)
• 17ß-estradiol 0.25 mg/progesterone 50 mg (n = 424)
• Placebo (n = 151)

The Replenish Trial results demonstrated:

• TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg both achieved all four of the co-primary efficacy endpoints and the primary safety endpoint.
• TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg both demonstrated a statistically significant and clinically meaningful reduction from baseline in both the frequency and severity of hot flashes compared to placebo.
• TX-001HR estradiol 0.5 mg/progesterone 50 mg and TX-001HR estradiol 0.25 mg/progesterone 50 mg were not statistically significant at all of the co-primary efficacy endpoints. The estradiol 0.25 mg/progesterone 50 mg dose was included in the clinical trial as a non-effective dose to meet the recommendation of the FDA guidance to identify the lowest effective dose.
• The incidence of consensus endometrial hyperplasia or malignancy was 0 percent across all four TX-001HR doses, meeting the recommendations established by the U.S. Food and Drug Agency’s (FDA) draft guidance.¹

As outlined in the FDA guidance, the co-primary efficacy endpoints in the Replenish Trial were the change from baseline in the number and severity of hot flashes at weeks 4 and 12 as compared to placebo.¹ The primary safety endpoint was the incidence of endometrial hyperplasia with up to 12 months of treatment. General safety was also evaluated.

The results of the Replenish Trial (p-values of < 0.05 meet FDA guidance and support evidence of efficacy) are summarized in the below table and included multimedia.

“We are very pleased that multiple doses of TX-001HR studied in the Replenish Trial demonstrated these positive results, suggesting that, if approved, this drug product candidate is poised to address the significant demand for bio-identical hormone therapy,” said Chief Executive Officer Robert G. Finizio. “We have successfully advanced the science for post-menopausal women’s health by finding a way to effectively combine bio-identical estradiol and bio-identical progesterone. The need for a bio-identical FDA-approved combination therapy has been unanswered for decades, driving women to use unapproved drugs mixed together by independent and community pharmacies that compound these products. We believe that TX-001HR, if approved, will provide women, healthcare providers and pharmacists with a proven safe, effective and insurance reimbursed bio-identical combination product, finally answering that need. We will continue to evaluate these promising data, and look forward to submitting a New Drug Application for TX-001HR to the Food and Drug Administration as early as the third quarter of 2017.”

The trial also demonstrated a dose response favoring the higher doses of estradiol in combination with progesterone. The availability of multiple doses of TX-001HR would allow for individualized therapy to meet the needs of a diverse population of women.

The most common adverse events (>5 percent) reported on average in all the active treatment groups were headache, nasopharyngitis, breast tenderness, and upper respiratory infection. There was a very low reported incidence of adverse events of somnolence with TX-001HR, in contrast to commercially available oral progesterone where somnolence has been reported as a significant side effect. There were no unexpected safety signals.

The Replenish Trial evaluated various secondary endpoints using well-validated patient reported outcome tools, including the Menopause-Specific Quality of Life (MENQOL), the Clinical Global Impression scale (CGI), and the responder analysis rate. Both TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg demonstrated clinically meaningful and statistically significant improvements in the secondary endpoints using these tools.

Additional efficacy and safety analyses of the Replenish Trial data are ongoing and TherapeuticsMD plans to submit the full Replenish Trial results for presentation at future scientific meetings and for publication in peer-reviewed journals.

“TX-001HR is the first bio-identical combination hormone therapy of estradiol in combination with progesterone to be evaluated in a large, well-controlled, randomized clinical trial,” said TherapeuticsMD Chief Medical Officer Sebastian Mirkin, M.D. “The Replenish Trial demonstrated for the first-time safety and robust efficacy for the treatment of hot flashes at multiple doses of TX-001HR. If approved, TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg would provide TherapeuticsMD with a complete portfolio to meet the demands of women currently taking unapproved compounded hormones for the treatment of VMS, along with the healthcare providers and pharmacies that prescribe and compound these products.”

About TX-001HR

TX-001HR is a novel combination of 17ß-estradiol and natural progesterone under investigation for treating vasomotor symptoms related to menopause. If approved by the FDA, TX-001HR would represent the first bio-identical estradiol and progesterone approved for use in a single, combined product for postmenopausal women with an intact uterus offering women an important alternative to both the available FDA-approved synthetic (non-bio-identical) hormones and the unapproved compounded bio-identical hormone products. Bio-identical refers to estradiol and progesterone that are molecularly identical to the hormones circulating naturally in the woman’s body. An estimated one to two-and-a-half million women in the U.S. are using unapproved, compounded bio-identical hormone therapies to treat vasomotor symptoms.² Leading medical societies and the FDA advise that compounded hormone therapies may pose significant risk to women given lack of efficacy and safety data and lack of uniform manufacturing processes.

TX-001HR was developed using TherapeuticsMD’s unique SYMBODA^TM technology (meaning “similar to the body”), which enables partial and complete solubilization of estradiol and progesterone into medium-chain fatty acid oils often derived from coconut oil.

About Menopause and Vasomotor Symptoms (VMS)

Menopause is a natural life-stage transition for women with an average onset of 51 years. According to the United States Census Bureau, approximately 43 million women in the U.S. are of menopausal age (45-64 years).³

As the ovaries stop producing hormones, levels of circulating estrogen decrease, often causing vasomotor symptoms (VMS) such as night sweats, hot flashes, and sleep disturbances. VMS affect as many as 60-80 percent of all menopausal women.

Menopausal women can benefit from hormone therapy (HT), also known as hormone replacement therapy (HRT), which is recognized by key medical societies as the most effective treatment for relief of symptoms related to menopause.

Conference Call and Webcast

TherapeuticsMD will host a conference call today, during which management will discuss the top-line results of the pivotal phase 3 Replenish Trial. Details for the call are:

Date: December 5, 2016

Time: 4:30 p.m. ET

Telephone Access (US): (866) 665-9531

Telephone Access (International): (724) 987-6977

Access Code for All Callers: 30215405

Additionally, a live webcast of the conference call can be accessed on the company’s website, www.therapeuticsmd.com, under the “Investors & Media” section.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA^™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company’s clinical development pipeline includes two phase 3 products. The company also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD^® and BocaGreenMD^® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com and www.bocagreenmd.com.

Forward Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize its hormone therapy drug candidates and obtain additional financing necessary therefor ; whether the company will be able to prepare a new drug application for its TX-001HR product candidate and, if prepared, whether the FDA will accept and approve the application; whether the FDA will approve the company’s new drug application for its TX-004HR product candidate and whether any such approval will occur by the PDUFA date; the length, cost and uncertain results of the company’s clinical trials; the potential of adverse side effects or other safety risks that could preclude the approval of the company’s hormone therapy drug candidates; the company’s reliance on third parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.

References

¹ 2003 FDA Draft Guidance for Industry Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommendations for Clinical Evaluation http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm071643.pdf

² Pinkerton JV, Santoro N. 2015. Menopause, Vol.22, No.9, pp 0-11

³ United States Census Bureau

$NDRM Opts for #ND0612 Small Pharmacokinetic Trials Post End-of-Phase2 #FDA Meeting

– Company to pursue comparative bioavailability regulatory route instead of clinical efficacy development route –
– NeuroDerm to add patients to its long-term safety trial –
– Conference call and webcast today at 8:00 a.m. ET –

REHOVOT, Israel, Dec. 05, 2016  — NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, today announced that following its End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) in late October, the Company intends to pursue a comparative bioavailability regulatory path for the Company’s lead product candidate ND0612 based on comparative pharmacokinetic (PK) data in place of data from Phase 3 clinical efficacy trials. The FDA also reaffirmed that long-term safety data from the Company’s ongoing BeyoND trial (trial 012) should be part of the eventual New Drug Application (NDA) submission.  ND0612 is the Company’s continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) proprietary liquid formulation for the treatment of Parkinson’s disease.

In the End-of-Phase 2 meeting, the Company presented clinical data obtained to date from its ND0612 trials and discussed details of its clinical development plan and requirements for an eventual application. The FDA provided recommendations related to Chemistry, Manufacturing, and Control (CMC) specifications, device development, clinical trials design as well as the implications of the current orphan drug status of Duopa® levodopa carbidopa intestinal gel (LCIG).

Following the discussions with the FDA the Company has decided to discontinue preparations to initiate its Phase 3 clinical efficacy trial of ND0612H (trial 010) and suspend iNDiGO, its other ongoing Phase 3 trial (trial 007) for ND0612L. Both studies are no longer required for marketing approval and will be replaced by comparative PK studies that will be initiated in the upcoming months. The Company is also evaluating amending the iNDiGO trial to a life cycle management trial. In addition, the Company will add approximately 50 patients to its ongoing long-term BeyoND safety trial (trial 012) with a different dosing regimen in line with the planned PK studies, which may add approximately three months to the timeline for completing the study and eventual application.

Notwithstanding the Company’s changes to its U.S. regulatory development plans, the Company’s clinical, comparative bioavailability-based EU regulatory development strategy remains unchanged, pending an anticipated meeting with EU authorities in January.

“We are extremely pleased with the outcome of this FDA meeting that led us to replace two large, Phase 3 efficacy trials, with small PK trials,” said Oded Lieberman, PhD, CEO of NeuroDerm. “We are encouraged by the support that we have received from all those who care about Parkinson’s disease and share our hope that ND0612 will transform patients’ lives.  ND0612 has been designed to become the first non-surgical continuous levodopa therapy. We hope that it may offer Parkinson’s disease patients a new, effective and convenient alternative to the highly invasive treatment options available today, that are associated with potentially serious and sometimes life-threatening side effects.  We are committed to bringing this innovative therapy to market as quickly as possible, and believe that a PK-based regulatory development route in the United States charts a clear path to ND0612 NDA submission.”

Conference Call Details
NeuroDerm will host a conference call at 8:00 a.m. ET today. To access the call, dial 844-452-2810 (U.S.) or 574-990-9831 (outside of the U.S.). The passcode is 32376402.  A live webcast will be available in the Events and Presentations section of the Investor Relations page at NeuroDerm.com.  Please log in approximately 5-10 minutes prior to the scheduled start time.

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 2 trials demonstrated that a low dose of ND0612 (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.  A high dose of ND0612 (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 central nervous system (CNS) product candidates that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration.  The Company 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.  The Company 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 candidate in low dose and high dose form (ND0612L and ND0612H), are used for the treatment of moderate and advanced Parkinson’s disease patients, respectively, and 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

$COWN Completes #Reverse #Stock #Split

Cowen Group, Inc. (NASDAQ:COWN) (“Cowen” or the “Company”) completed its previously announced one-for-four reverse stock split. Pursuant to the reverse split, common shareholders automatically received one common share for every four common shares owned. The Company’s Class A common stock will begin trading on a reverse split adjusted basis on the NASDAQ Global Market at the opening of trading on December 5, 2016 under the symbol “COWN.” In connection with the reverse stock split, the Company’s Class A common stock CUSIP will change to USIP number 223622606.

The Company believes that existing stockholders will benefit from the ability to attract a broader range of investors as a result of the reverse stock split and a higher per share stock price.

The reverse stock split uniformly affects all record holders of common stock and does not affect any record holder’s percentage ownership in the Company, except for de minimis changes as a result of the elimination of fractional shares. The reverse stock split reduced the number of Class A shares of common stock outstanding from approximately 107,337,144 as of December 5, 2016 to approximately 26,834,286 shares post-split.

All outstanding preferred shares, stock options, stock appreciation rights, warrant, and equity incentive plans immediately prior to the reverse stock split will be appropriately adjusted by dividing the number of shares of Class A common stock into which the preferred shares, stock options, stock appreciation rights, warrants and equity incentive plans of the Class A common stock are exercisable or convertible by four and multiplying the exercise or conversion price by four, as a result of the reverse stock split.

The reverse stock split did not affect the number of authorized or outstanding shares of the Company’s 5.625% Series A Cumulative Perpetual Convertible Preferred Stock (“Preferred Stock”) or the dividend rate per share of any outstanding shares of Preferred Stock. The conversion price and conversion rate have been adjusted and effective as of the open of business on December 5, 2016. As a result of the adjustment, the conversion rate is 38.0619 and the conversion price is $26.2730.

The conversion rate of the Company’s 3.0% Cash Convertible Senior Notes due 2019 (“Convertible Notes”) automatically adjusted as follows: the conversion rate of the Convertible Notes adjusted from 187.62 shares of Common Stock per $1,000 principal amount of such notes to 46.905 shares of Common Stock per $1,000 principal amount of such notes. The maximum total number of shares of common stock issuable upon conversion in connection with a “Make Whole Adjustment” under the Convertible Notes adjusted from 28,048,786 shares per $1,000 principal amount of such notes to 7,012,196 shares of Common Stock per $1,000 principal amount of such notes.

No fractional shares will be issued in connection with the reverse split. Stockholders of fractional shares of the Company’s Class A common stock will receive a cash payment at a price equal to the closing price of the Company’s Class A common stock as of December 2, 2016. Stockholders who hold their shares in brokerage accounts or “street name” are not required to take any action in connection with the reverse stock split. Their accounts will be automatically adjusted to reflect the new number of shares owned. A letter of transmittal relating to the reverse stock split will be sent to record holders of certificates of Class A common stock. Stockholders who receive this communication should follow the instructions in that letter.

About Cowen Group, Inc.

Cowen Group, Inc. is a diversified financial services firm and, together with its consolidated subsidiaries, provides alternative asset management, investment banking, research, sales and trading and prime brokerage services through its two business segments: Ramius and its affiliates make up the Company’s alternative investment segment, while Cowen and Company, a member of FINRA and SIPC, and its affiliates make up the Company’s broker-dealer segment. Ramius provides alternative asset management solutions to a global client base and manages a significant portion of Cowen’s proprietary capital. Cowen and Company and its affiliates offer industry focused investment banking for growth-oriented companies, domain knowledge-driven research, a sales and trading platform for institutional investors and a comprehensive suite of prime brokerage services. Founded in 1918, the firm is headquartered in New York and has offices worldwide. For additional information, visit www.cowen.com.

$SOHO Announces Board Authorization of #Stock #Repurchase Program

WILLIAMSBURG, Va., Dec. 02, 2016  — Sotherly Hotels Inc. (NASDAQ:SOHO) (the “Company”) today announced that its Board of Directors authorized a stock repurchase program under which the Company may acquire up to $10 million of its outstanding common stock, at the discretion of management.  The Company expects to complete the repurchase program prior to December 31, 2017, unless extended by the Board of Directors.

The shares will be purchased pursuant to the program from time to time at prevailing market prices, through open market or privately negotiated transactions, depending upon market conditions and may be made pursuant to one or more plans established pursuant to Rule 10b5-1 under the Securities Exchange Act, as amended. Under the program, the purchases will be funded from available working capital. There is no guarantee as to the exact number of shares that will be repurchased by the Company and the Company may discontinue purchases at any time that management determines additional purchases are not warranted. As of November 8, 2016, the Company had approximately 14.9 million shares outstanding.

Drew Sims, CEO and Chairman of the Company, remarked, “The Board’s approval of this program reflects our confidence in the Company’s future. Repurchasing stock is one means of underscoring our commitment to enhancing stockholder value.”

Forward Looking Statements

This news release includes “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. Although the Company believes that the expectations and assumptions reflected in the forward-looking statements are reasonable, these statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions which are difficult to predict and many of which are beyond the Company’s control. Therefore, actual outcomes and results may differ materially from what is expressed, forecasted or implied in such forward-looking statements. Factors which could have a material adverse effect on the Company’s future results, performance and achievements, include, but are not limited to: national and local economic and business conditions that affect occupancy rates and revenues at the Company’s hotels and the demand for hotel products and services; risks associated with the hotel industry, including competition, increases in wages, energy costs and other operating costs; the magnitude and sustainability of the economic recovery in the hospitality industry and in the markets in which the Company operates; the availability and terms of financing and capital and the general volatility of the securities markets; risks associated with the level of the Company’s indebtedness and its ability to meet covenants in its debt agreements and, if necessary, to refinance or seek an extension of the maturity of such indebtedness or modify such debt agreements; management and performance of the Company’s hotels; risks associated with maintaining our system of internal controls; risks associated with the conflicts of interest of the Company’s officers and directors; risks associated with redevelopment and repositioning projects, including delays and cost overruns; supply and demand for hotel rooms in the Company’s current and proposed market areas; risks associated with our ability to maintain our franchise agreements with our third party franchisors; the Company’s ability to acquire additional properties and the risk that potential acquisitions may not perform in accordance with expectations; the Company’s ability to successfully expand into new markets; legislative/regulatory changes, including changes to laws governing taxation of REITs; the Company’s ability to maintain its qualification as a REIT; and the Company’s ability to maintain adequate insurance coverage. These risks and uncertainties are described in greater detail under “Risk Factors” in the Company’s Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to and does not intend to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Although the Company believes its current expectations to be based upon reasonable assumptions, it can give no assurance that its expectations will be attained or that actual results will not differ materially.

About Sotherly Hotels Inc.
Sotherly Hotels Inc. is a self-managed and self-administered lodging REIT focused on the acquisition, renovation, upbranding and repositioning of upscale and upper-upscale full-service hotels in the Southern United States.  Currently, the Company’s portfolio consists of investments in twelve hotel properties, comprising 3,011 rooms. Most of the Company’s properties operate under the Hilton Worldwide, InterContinental Hotels Group and Marriott International, Inc. brands. Sotherly Hotels Inc. was organized in 2004 and is headquartered in Williamsburg, Virginia.  For more information, please visit www.sotherlyhotels.com

Contact at the Company:

Scott Kucinski 
Sotherly Hotels Inc.
410 West Francis Street
Williamsburg, Virginia 23185  
(757) 229-5648

$SENS Expands Distribution Agreement with #Roche

Senseonics Holdings, Inc. (NYSE-MKT:SENS), a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced it has expanded its exclusive distribution agreement with Roche to include all of Europe, the Middle East and Africa (EMEA), excluding Scandinavia, Finland and Israel. In May of this year, Senseonics signed an exclusive distribution with Roche for the commercialization of Senseonics’ Eversense® Continuous Glucose Monitoring System in Germany, Italy and the Netherlands.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161202005186/en/

Under the terms of the expanded agreement, Senseonics has granted Roche exclusive rights to promote, market, and sell the Eversense product line to diabetes clinics and patients in the covered territories.

“The partnership we formed with Roche earlier this year is off to a promising start. The early success and experience that each of our teams are gaining drove the mutual decision to expand our relationship. We are excited to add these additional countries and look forward to growing the presence of Eversense through this partnership,” said Tim Goodnow, CEO and President of Senseonics.

Senseonics will retain responsibility for product development, regulatory approval, quality management, and manufacturing, while Roche will be responsible for sales, marketing, customer support and distribution activities in the covered territories.

About Senseonics

Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics’ first generation CGM system, Eversense®, includes a small sensor, smart transmitter and mobile application. Based on fluorescence sensing technology, the sensor is designed to be inserted subcutaneously and communicate with the smart transmitter to wirelessly transmit glucose levels to a mobile device. After insertion, the sensor is designed to continually and accurately measure glucose levels. For more information on Senseonics, please visit www.senseonics.com.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com

About Roche Diabetes Care

Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. For more than 40 years, the Accu-Chek brand has been dedicated to enabling people with diabetes to live life as normally and actively as possible as well as to empowering healthcare professionals to manage their patients’ condition in an optimal way. Today, the Accu-Chek portfolio offers people with diabetes and healthcare professionals innovative products and impactful solutions for convenient, efficient and effective diabetes management, spanning from blood glucose monitoring through information management to insulin delivery. The Accu-Chek brand encompasses blood glucose meters, insulin delivery systems, lancing devices, data management systems and education programs – contributing to an improved medical outcome.

For more information please visit www.accu-chek.com

All trademarks used or mentioned in this release are protected by law.

Forward Looking Statements

Certain statements contained in this press release, other than statements of fact that are independently verifiable at the date hereof, may constitute “forward-looking statements.” These forward-looking statements reflect Senseonics’ current views about its plans, intentions, expectations, strategies and prospects, including statements concerning the marketing and commercialization of Eversense in Europe, the Middle East and Africa, which are based on the information currently available to Senseonics and on assumptions Senseonics has made. Although Senseonics believes that its plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, Senseonics can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond Senseonics’ control. Other risks and uncertainties are more fully described in the section entitled “Risk Factors” in Senseonics’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 19, 2016, its Quarterly Report on Form 10-Q filed with the SEC on November 3, 2016 and its other SEC filings. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause Senseonics’ expectations and beliefs to change. Unless otherwise required by applicable securities laws, Senseonics does not intend, nor do it undertake any obligation, to update or revise any forward-looking statements contained in this news release to reflect subsequent information, events, results or circumstances or otherwise. While Senseonics may elect to update these forward-looking statements publicly at some point in the future, Senseonics specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law.

Senseonics Holdings, Inc.
R. Don Elsey, 301-556-1602
Chief Financial Officer
don.elsey@senseonics.com

$CALA Announces #CB839 #Preclinical Data for 58th American Society of #Hematology

SOUTH SAN FRANCISCO, Calif., Dec. 02, 2016  — Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, today announced that preclinical data for its lead drug candidate CB-839, the company’s novel, orally bioavailable glutaminase inhibitor, will be presented at the 58th American Society of Hematology (ASH) Annual Meeting, which is being held from December 3-6, 2016 in San Diego, California. Data to be presented include the following two poster presentations:

Glutaminase Inhibitor CB-839 Enhances Proteasome Inhibitor Sensitivity in Multiple Myeloma Cells
Presenter: Ravyn Thompson, Nathan Dolloff, Medical University of South Carolina
Oral and Poster Abstracts Session 652: Myeloma: Pathophysiology and Preclinical Studies, Hall GH, Abstract 3294
Sunday, December 4, 2016, 6:00 p.m.-8:00 p.m. PT

Gls Inhibitor CB-839 Modulates Cellular Metabolism in AML and Potently Suppresses AML Cell Growth When Combined with 5-Azacitidine
Presenter: Tianyu Cai, Marina Konopleva, The University of Texas, MD Anderson Cancer Center
Oral and Poster Abstracts Session 616: Acute Myeloid Leukemia: Novel Therapy, Hall GH, Abstract 4064
Monday, December 5, 2016, 6:00 p.m.-8:00 p.m. PT

About Calithera Biosciences

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.  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

$SPU to Hold Annual Shareholders Meeting on December 29, 2016

XI’AN, China, Dec. 2, 2016  — SkyPeople Fruit Juice, Inc. (NASDAQ: SPU) (“SkyPeople” or “the Company”), a producer of fruit juice concentrates, fruit juice beverages and other fruit-related products, announced that it will hold its 2016 Annual Meeting of Shareholders (the “Annual Meeting”) on December 29, 2016, at 10:00 AM, local time, at the Company’s principal executive offices located at 16F, China Development Bank Tower, No. 2, Gaoxin 1^st Road, Xi’an, Shannxi, China.

As fully discussed in the definitive proxy statement filed with the Securities and Exchange Commission (the “SEC”), the Annual Meeting will be for the following purposes:

(1) To elect five directors to hold office until the next Annual Meeting of Shareholders and until their successors are elected and qualified; and

(2) To ratify the Audit Committee’s selection of the independent registered public accounting firm for the fiscal year ending December 31, 2016; and

(3) To transact such other business as may properly come before the meeting or any adjournment thereof.

Stockholders of record at the close of business on November 4, 2016 are entitled to receive notice and vote at the meeting.

Additional Information

This press release may be deemed to be solicitation material in respect of the annual meeting.  In connection with the annual meeting, the Company filed with the Securities and Exchange Commission on December 1, 2016, a definitive proxy statement, which is publicly available, and has mailed such definitive proxy statement to stockholders on or about December 1, 2016. INVESTORS AND STOCKHOLDERS ARE URGED TO READ CAREFULLY AND IN THEIR ENTIRETY THE PROXY STATEMENT AND OTHER MATERIALS FILED WITH THE SEC IN CONNECTION WITH THE ANNUAL MEETING, AS THEY CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, THE PROPOSALS, THE PERSONS SOLICITING PROXIES IN CONNECTION WITH THE PROPOSALS ON BEHALF OF THE COMPANY, AND THE INTERESTS OF THOSE PERSONS IN THE PROPOSALS AND RELATED MATTERS. Stockholders may access the Company’s definitive proxy statement, without charge, at the SEC’s website www.sec.gov.

About SkyPeople Fruit Juice, Inc.

SkyPeople Fruit Juice, Inc., a Florida company, through its wholly-owned subsidiary Pacific Industry Holding Group Co., Ltd. (“Pacific”), a Vanuatu company, and SkyPeople Juice International Holding (HK) Ltd., a company organized under the laws of Hong Kong Special Administrative Region of the People’s Republic of China and a wholly owned subsidiary of Pacific, holds 73.42% ownership interest in SkyPeople Juice Group Co., Ltd. (“SkyPeople (China)”) and 100% ownership interest in SkyPeople Foods (China) Co., Ltd. (“SkyPeople Foods China”). SkyPeople (China) and (“SkyPeople Foods China”), together with their operating subsidiaries in China, are engaged in the production and sales of fruit juice concentrates, fruit beverages, and other fruit related products in the PRC and overseas markets. The Company’s fruit juice concentrates are sold to domestic customers and exported directly or via distributors. Fruit juice concentrates are used as a basic ingredient component in the food industry. Its brands, “Hedetang” and “SkyPeople,” which are registered trademarks in the PRC, are positioned as high quality, healthy and nutritious end-use juice beverages. For more information, please visit http://www.skypeoplefruitjuice.com.

Safe Harbor Statement

Certain of the statements made in this press release are “forward-looking statements” within the meaning and protections of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions, and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause the actual results, performance, capital, ownership or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “will,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “estimate,” “continue,” “plan,” “point to,” “project,” “could,” “intend,” “target” and other similar words and expressions of the future.

All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary notice, including, without limitation, those risks and uncertainties described in our annual report on Form 10-K for the year ended December 31, 2015 and otherwise in our SEC reports and filings, including the final prospectus for our offering. Such reports are available upon request from the Company, or from the Securities and Exchange Commission, including through the SEC’s Internet website at http://www.sec.gov. We have no obligation and do not undertake to update, revise or correct any of the forward-looking statements after the date hereof, or after the respective dates on which any such statements otherwise are made.

For more information, please contact:

$SBOT to Present at the #LDMicro @theLDMicro Main Event Investor Conference

$KURA Presents Preclinical Data on #KO947 & #MeninMLL

LA JOLLA, Calif., Dec. 01, 2016  — Kura Oncology, Inc. (Nasdaq:KURA), a clinical stage biopharmaceutical company, today presented preclinical data highlighting the identification and characterization of KO-947, its development candidate targeting ERK1/2 kinases. The company has also presented preclinical data relating to the identification and optimization of potent and selective inhibitors of the menin-MLL interaction. Both presentations took place at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (EORTC) in Munich, Germany.

“We are excited to present preclinical data from these two innovative programs at EORTC, both of which showed compelling activity in preclinical models of cancer,” said Yi Liu, Ph.D., Chief Scientific Officer. “Looking forward, we anticipate nominating a development candidate for our menin-MLL program by the end of 2016, and initiating a Phase 1 clinical trial for KO-947 in the first half of 2017.”

KO-947 – A potent and selective inhibitor of ERK1/2 kinases

The RAS/RAF/MEK pathway is estimated to be activated in more than 30% of human cancers, including cancers arising from mutations in KRAS, NRAS and BRAF. Although inhibitors of both BRAF and MEK have been approved for treatment of melanoma, acquired resistance to these inhibitors has been documented both in preclinical and clinical samples due to reactivation of ERK1/2 kinases.

In preclinical studies presented today at EORTC, KO-947 showed potent inhibition of ERK signaling pathways and proliferation of tumor cells exhibiting dysregulation of MAPK pathway, including mutations in BRAF, NRAS or KRAS. KO-947 also inhibits MAPK signaling and cell proliferation in preclinical models that are resistant to BRAF and MEK inhibitors. Results obtained from screening a large panel of PDX models demonstrate that KO-947 induces tumor regressions in BRAF or RAS mutated tumor models as well as in tumor models lacking BRAF/RAS mutations but characterized by other dysregulation of the MAPK pathway.

KO-947 appears to be differentiated from other published ERK inhibitors by an extended residence time and prolonged pathway inhibition in vitro and in vivo. The data further suggest that the drug properties of KO-947 may allow Kura to maximize the therapeutic window with flexible administration routes and schedules, including intermittent dosing.

Inhibitors of the Menin-MLL Interaction

Chromosomal translocations that affect the mixed lineage leukemia (MLL) gene result in aggressive acute myeloid and lymphoid leukemias that are often resistant to standard chemotherapy. Approximately 5-10% of acute leukemias in adults, and 70% of acute leukemias in infants, are characterized by tumors with abnormal MLL fusions. MLL fusion proteins require menin for leukemogenic activity and selective disruption of the menin-MLL interaction represents a potential therapeutic approach for the treatment of acute leukemias with MLL rearrangements.

In preclinical studies presented at EORTC, inhibitors of the menin-MLL interaction showed potent inhibition of the proliferation of MLL leukemic cells. Inhibitors of the menin-MLL interaction displayed a greater than 50-fold reduction in potency in non-MLL-fusion leukemia cell lines and induced regression in a MV4:11 mouse xenograft model. The data show that the anti-tumor activity of menin-MLL inhibitors correlates with target engagement in tumors as well as inhibition of expression of downstream genes under the regulation of the fusion protein. Moreover, the inhibitors demonstrated potent efficacy in subcutaneous and disseminated models of MLL-fusion leukemias.

Both of the posters presented at EORTC can be found on Kura’s website in the Scientific Presentations and Papers section or by clicking here.

About Kura Oncology

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The company’s pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, which is currently being studied in multiple Phase 2 clinical trials. The preclinical pipeline includes KO-947, an ERK inhibitor, and a menin-MLL program. For additional information about Kura Oncology, please visit the company’s website at www.kuraoncology.com.

Forward Looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the potential utility KO-947 and Kura Oncology’s other compounds and product candidates, the conduct, results and timing of preclinical studies and clinical trials and plans regarding future research and development. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura Oncology may not obtain approval to market its product candidates, uncertainties associated with regulatory filings and applications, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further research, clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura Oncology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT INFORMATION

INVESTOR CONTACT:
Robert H. Uhl
Managing Director
Westwicke Partners, LLC
(858) 356-5932
robert.uhl@westwicke.com

MEDIA CONTACT:
Mark Corbae
Vice President
Canale Communications
(619) 849-5375
mark@canalecomm.com

$SKLN VP Sales on WPSL-AM 1590 #MONEYINFO Program

Peter Alex Discusses Canadian Marketing and Distribution Plans for STREAMWAY® System

MINNEAPOLIS, Dec. 01, 2016  — Skyline Medical Inc. (NASDAQ:SKLN) (“Skyline” or “the Company”), producer of the FDA-approved STREAMWAY® System for automated, direct-to-drain medical fluid disposal, announces that Peter Alex, Vice President of Sales, was interviewed Tuesday on WPSL’s “MONEYINFO by PRINCETON RESEARCH with MIKE KING and CHARLES MOSKOWITZ” radio show.

The discussion focused on the STREAMWAY System’s recent regulatory approval in Canada and plans for marketing and distribution under its large, single-payer system.  In addition, Mr. Alex discussed the company’s new sales focus on general purchasing organizations and large surgical practice groups in the U.S.

The interview is available on Princeton Research’s website at http://www.princetonresearch.com/small-cap-undervalued-stocks-nov-29-2016/ and on the Investor Information section of Skyline Medical’s website at www.skylinemedical.com.

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; the potential delisting of the Company’s common stock on The Nasdaq Capital Market as a result of the Company’s failures to comply with listing standards, in which case the liquidity of our common stock would likely be impaired and there would likely be a reduction in our coverage by security analysts and the news media, thereby resulting in lower prices for our common stock than might otherwise prevail; 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

MoneyInfo, LLC
Charles Moskowitz
(781) 826-8882
cam@moneyinfo-llc.com

$MKGI Recruiter.com Launches Custom Travel & Loyalty Program via #Monaker #Partnership

Exclusive two-tiered travel and loyalty program is tailored for career professionals