Lehman Brothers Eighth Annual Global Healthcare Conference March 30, 2005 Bruce A. Peacock President and Chief Executive Officer
|
|
- Kelly Arline Armstrong
- 5 years ago
- Views:
Transcription
1
2 Lehman Brothers Eighth Annual Global Healthcare Conference March 30, 2005 Bruce A. Peacock President and Chief Executive Officer 2005 Adolor Corporation. All rights reserved.
3 Safe Harbor Statement This oral presentation and the questions and answers that follow contain forward-looking statements, including, but not limited to, statements about: anticipated date of providing FDA with information about Study 001 anticipated actions with respect to the FDA target action date for our NDA for Entereg our ability to receive FDA approval for our NDA for Entereg our collaborator s plans for development of Entereg in the management of postoperative ileus our collaborator s plans for development of Entereg in opioid bowel dysfunction including targets for initiating further clinical trials and a NDA submission target anticipated dates of clinical trial initiation, completion, and announcement of trial results by us and our collaborators anticipated dates for regulatory submissions by us and our collaborators and regulatory actions anticipated results of clinical trials anticipated efforts of our collaborators our plans for manufacturing and supply for our products our ability to complete additional studies for ADL our research efforts anticipated operating losses and capital expenditures estimates of the market opportunity and the commercialization plans for our product candidates our ability to acquire or in-license products and product candidates our plans to build a hospital-focused sales staff. These statements are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such known risks and uncertainties relate to, among other factors: the risk that Adolor does not submit the information from Study 001 in a timely manner for FDA to consider in connection with the New Drug Application (NDA) for use of Entereg in postoperative ileus (POI); the risk that the FDA does not extend the PDUFA target action date; the risk that the FDA may not meet the PDUFA target action date; the risk that Adolor may not obtain FDA approval of the Entereg POI NDA whether due to the adequacy of Studies 302, 306, 308 and 313 to support FDA approval, FDA not agreeing with our analyses of Studies 302, 306, 308 and 313 and evaluating the results of these studies by different methods or concluding that the results from the studies are not statistically significant, clinically meaningful or do not support safety, or that there were human errors in the conduct of the studies or otherwise, the adequacy of the development program, results from Study 001, the conduct of the clinical trials, changing regulatory requirements, different methods of evaluating and interpreting data, reliance on third party manufacturers, unfavorable results from ongoing clinical trials, including trials being conducted by our collaborator, adverse safety findings, or otherwise; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; the risk that the results from Study 001 do not support the submission of a marketing approval application for Entereg in Europe; the risk of unfavorable results of Entereg in trials in other indications; the risk that NDAs may not be submitted in other indications; Adolor s history of operating losses since inception and its need for additional funds to operate its business; Adolor s reliance on its collaborators, including GlaxoSmithKline, in connection with the development and commercialization of Entereg ; market acceptance of Adolor s products, if regulatory approval is achieved; securities litigation; competition; and other risk factors detailed from time to time in reports filed by Adolor with the Securities and Exchange Commission. We urge you to carefully review and consider the disclosures found in these filings which are available in the SEC EDGAR database at Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Adolor undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise.
4 Adolor Addressing Significant Market Opportunities Opioid Analgesics Over $5 billion U.S. market More than 240 million scripts are estimated to be written in the U.S. each year Need for Better management of GI side effects Improved product profile reduction of other side effects or abuse potential
5 Product Development Pipeline Entereg (alvimopan) Postoperative Ileus (POI) Chronic Opioid Bowel Dysfunction (cobd) Sterile Lidocaine Patch Postoperative Incisional Pain Analgesic Discovery Research Programs Novel Opioid and Non-opioid Targets Focused on Moderate to Severe Pain
6 Adolor and GlaxoSmithKline Entereg (alvimopan) Collaboration ROW development and promotion Ex-US royalties US co-development/ co-promotion profit split Milestones received: $50,000,000 upon signing $10,000,000 on NDA acceptance ROW/US manufacturing
7 Adolor/GSK Arixtra Co-Promotion Relationship with GSK expanded in January 2005 to include co-promotion of GSK s Arixtra for the prophylaxis of deep vein thrombosis (DVT) Adolor deploying a Field Force comprised of 3 regional directors and 30 specialty account managers targeting surgeons and related healthcare professionals Two-year agreement; GSK providing cost reimbursement for Adolor reps ARIXTRA is a registered trademark of GlaxoSmithKline
8 Entereg (alvimopan) Postoperative Ileus (POI) Chronic Opioid Bowel Dysfunction (cobd) Sterile Lidocaine Patch Postoperative Incisional Pain Analgesic Discovery Research Programs Novel Opioid and Non-opioid Targets Focused on Moderate to Severe Pain
9 Alvimopan Mechanism of Action Mu Opioid Narcotic Analgesics: - morphine - codeine - oxycodone Central Mu Opioid Receptor Alvimopan is a patented small molecule that antagonizes G.I. Opioid Receptors Peripheral Mu Opioid Receptors in Bowel Postoperative Ileus, Opioid Bowel Dysfunction
10 Postoperative Ileus Impairment of G.I. motility after abdominal or other surgeries Major factor contributing to postoperative discomfort Opioid analgesics used for treatment of postoperative pain delay G.I. recovery Delays gastrointestinal recovery and often prolongs hospital stay No current FDA approved pharmacologic treatments to manage POI
11 Entereg (alvimopan) for the Management of Postoperative Ileus U.S. Phase 3 Studies Study N= 2,146 Treatment Arms Primary Objective Population (%MITT) 302 N=451 6 mg 12 mg Placebo Efficacy Bowel Resection (70%) Radical Hysterectomy (8%) Simple Hysterectomy (23%) 313 N=510 6 mg 12 mg Placebo Efficacy Bowel Resection (96%) Radical Hysterectomy (4%) 308 N=666 6 mg 12 mg Placebo Efficacy Bowel Resection (68%) Radical Hysterectomy (17%) Simple Hysterectomy (15%) 306 N= mg Placebo Safety Simple Hysterectomy (100%)
12 Entereg (alvimopan) for the Management of Postoperative Ileus, Phase 3 Efficacy Studies Primary Efficacy Endpoint Time to recovery of gastrointestinal (GI) function last to occur of upper GI recovery (solid food) and lower GI recovery (first of flatus or bowel movement) = GI 3 Study 14CL302 14CL313 14CL308 EU Study 001** 6 mg P-value <0.01* <0.05* < mg P-value <0.01* Generally well tolerated; in addition to nausea and vomiting, abdominal distension (Study 302), hypotension (Study 313), pruritus (Study 308) and pyrexia (EU Study 001) are included in the 3 most frequent adverse events. **Primary analysis reflects bowel resection subjects only (total enrolled was 911 subjects including 170 radical hysterectomy subjects) * Statistically significant 1 Due to the multiple dose comparison to a single placebo group, a p-value less than is required for statistical significance when one p-value is > 0.05
13 Entereg (alvimopan) for the Management of Postoperative Ileus, Phase 3 Safety Study Study 306 Primary Objective Alvimopan was generally well tolerated Most frequent adverse events were : Placebo (N=106) 12 mg (N=413) Nausea 64.2% 72.6% Vomiting Constipation 25.5% 31.1% 31.5% 23.0% Discontinuations for adverse events: Total 4.7% 3.9%
14 Entereg (alvimopan) for the Management of Postoperative Ileus, Phase 3 Safety Study Study 306 Summary of Secondary Objectives 2 Mean in hours Time to: Alvimopan Placebo Difference First Flatus First Solids D/C Order GI First BM * GI * Responder 1 75% 72% * Denotes Statistically Significant 1 Defined as proportion of patients achieving GI recovery within 60 hours 2 Patients were evaluated both in the hospital as well as when they went home, for a total of 7 days of treatment
15 Entereg (alvimopan) for the Management of Postoperative Ileus, Phase 3 Efficacy Studies Secondary Efficacy Endpoint Time to recovery of gastrointestinal (GI) function last to occur of upper GI recovery (solid food) and lower GI recovery (bowel movement) = GI 2 Study 14CL CL313 14CL308 6 mg P-value <0.01* <0.05* <0.01* 12 mg P-value <0.001* <0.05* EU Study 001** <0.001 * 0.008* **Primary analysis reflects bowel resection subjects only (total enrolled was 911 subjects including 170 radical hysterectomy subjects) * Statistically significant 1 Not a prespecified endpoint for study 302
16 Entereg (alvimopan) for the Management of Postoperative Ileus, Study 313 Additional Analysis Hospital Discharge Order Written by Postoperative Day 30 % of Subjects Placebo 12 mg Postoperative Day
17 Summary of Entereg Clinical Studies for the Management of POI U.S. Phase 3 Clinical Studies Primary endpoint GI 3 Statistically significant difference in 2 U.S. pivotal studies; 12 mg dose submitted in proposed indication Secondary endpoints Difference in favor of Entereg (TM) as compared to placebo in all secondary endpoints in all 3 efficacy studies Fewer reports of nausea, vomiting, nasogastric tube re-insertion and hospital re-admission Generally well tolerated in all Phase 3 studies EU Phase 3 Clinical Study EU data targeted to be provided to the FDA in a time frame that would allow for an extension of 3 months to the PDUFA target action date from April 25, 2005 to July 25, 2005 GSK target for submission of MAA 2005
18 Entereg (alvimopan) Postoperative Ileus (POI) Chronic Opioid Bowel Dysfunction (cobd) Sterile Lidocaine Patch Postoperative Incisional Pain Analgesic Discovery Research Programs Novel Opioid and Non-opioid Targets Focused on Moderate to Severe Pain
19 In effect, I am a virtual prisoner in my own body Georgetown s pain management specialist assured me there was no reason to be in pain take more pain medication when I needed it. You don t have to tell me that twice. The only problem was that the painkillers brought on more constipation, which brought on more pain. While in the hospital, I had half the staff at Georgetown concerned with my bowels. Cathy Hainer, Reporter, USA Today
20 Entereg (alvimopan) Chronic Opioid Bowel Dysfunction Impairment of GI motility associated with chronic opioid use characterized by: Constipation, abdominal distension & bloating An additional quality of life impediment for chronic pain sufferers No current FDA approved treatments specifically to manage cobd 79.2% 190 mm Rx s for 1-14 days duration 240 million Opioid Rx s in the U.S. 20.8% 50 mm Rx s for 15+ days duration
21 Entereg (alvimopan) Chronic OBD Study 011 Phase 2b Efficacy Study Primary Efficacy Endpoint Spontaneous bowel movement (SBM) defined as bowel movement with no laxative use in previous 24 hours Dose Placebo SBM change from baseline weeks SBM SBM change from baseline weeks SBM 0.5 mg 2x/day 3.36 SBM* 3.58 SBM* 1.0 mg 1x/day 3.29 SBM* 3.39 SBM* 1.0 mg 2x/day 4.17 SBM* 4.34 SBM* N=522 non-cancer patients suffering from chronic pain AEs affecting the GI tract were the most common, occurring in 30-43% of alvimopan treated patients, compared to 36% on placebo. The most frequently reported AEs were abdominal pain, nausea and diarrhea and GI adverse events were also the most common reason for study withdrawal. Alvimopan was generally well tolerated. The incidence of any patient reporting of an AE was numerically similar between treatment and placebo groups *Statistically significant
22 Entereg (alvimopan) Ongoing Development Program QOL in POI, pre-op dose window, GI recovery OBD in cancer pain subjects Status Clinical study ongoing Clinical study ongoing by GSK Combo Product Formulation and assay evaluation
23 Entereg (alvimopan) Postoperative Ileus (POI) Chronic Opioid Bowel Dysfunction (cobd) Sterile Lidocaine Patch Postoperative Incisional Pain Analgesic Discovery Research Programs Novel Opioid and Non-opioid Targets Focused on Moderate to Severe Pain
24 Sterile Lidocaine Patch Important strategic asset in Adolor s focus on pain management Second lead product candidate; intended for incisional pain Robust lidocaine patch market exists today; unmet need in surgical application Potential market size: 17 million procedures in U.S. U. S. Phase 2 study targeted for 2005 Leverage potential for field hospital sales force
25 Sterile Lidocaine Patch Phase 2 Clinical Study Double-blind, randomized, placebo controlled study (N = 215) Hernia repair surgery Primary efficacy endpoint; pain intensity scores measured 2-48 hours Treatment for 48 hours VAS Pain Scores (AUC) Placebo 9.5% Lidocaine Patch P=0.06 P=0.015 P= Time Post Surgery (hours) 27% Pain Reduction ]
26 Entereg (alvimopan) Postoperative Ileus (POI) Chronic Opioid Bowel Dysfunction (cobd) Sterile Lidocaine Patch Postoperative Incisional Pain Analgesic Discovery Research Programs Novel Opioid and Non-opioid Targets Focused on Moderate to Severe Pain
27 Adolor Discovery Research Strategic Goal The discovery and development of novel compounds with the broad beneficial therapeutic effects of opioids with reduced side effects or abuse potential Approaches Structurally novel centrally acting opioid receptor agonists Non-opioid receptor agonists Peripheral opioid and non-opioid receptor agonists
28 Delta Opioid Receptor Agonists Activity in Inflammatory Pain Model p < VEHICLE NTI (0.3 mg/kg s.c.) 150 % Antihyperalgesia CONTROL ACTIVE Delta Agonist
29 Delta Opioid Receptor Program Status Potent, selective delta opioid receptor agonist Novel, proprietary chemical structure Orally bioavailable Activity in several rodent pain models Satisfactory non-clinical safety profile Next steps Scale-up compound manufacturing Pre-clinical IND support studies IND Filing target = late 2005
30 Financial Results (unaudited, in millions) Twelve Months Ended December 31, 2004 Revenues $25.5 Net Loss $43.6 December 31, 2004 Cash and Investments $162.3 Total Assets $178.1 Total Stockholders Equity $123.2 Shares Outstanding 39.1
31 Adolor Highlights Worldwide development and commercialization collaboration with GSK for Entereg US POI - NDA Submitted; EU data to be provided Chronic OBD Phase 2 statistically significant results reported NDA target 2007 Field force co-promoting Arixtra Initiate Sterile Lidocaine Patch Phase 2 program targeted in 2H 2005 Advance discovery compound into development targeted in 2H 2005
32 2005 Adolor Corporation. All rights reserved. Adolor Corporation 700 Pennsylvania Drive Exton, PA
Theravance Announces Positive Results from Phase 1 and Phase 2 Clinical Studies with TD-1211 in Development for Opioid-Induced Constipation
Theravance Announces Positive Results from Phase 1 and Phase 2 Clinical Studies with TD-1211 in Development for Opioid-Induced Constipation TD-1211 Achieves Primary and Secondary Endpoints SOUTH SAN FRANCISCO,
More informationAVENUE THERAPEUTICS, INC. NASDAQ: ATXI JANUARY 2018
AVENUE THERAPEUTICS, INC. NASDAQ: ATXI JANUARY 2018 Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward-looking statements within the meaning
More informationARDELYX REPORTS POSITIVE T3MPO-2 PHASE 3 TRIAL RESULTS IN IBS-C
ARDELYX REPORTS POSITIVE T3MPO-2 PHASE 3 TRIAL RESULTS IN IBS-C OCTOBER 11, 2017 NASDAQ: ARDX FORWARD-LOOKING STATEMENTS To the extent that statements contained in this presentation are not descriptions
More informationIRONWOOD AND FOREST ANNOUNCE POSITIVE LINACLOTIDE RESULTS FROM PHASE 3 TRIAL IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION
FOR IMMEDIATE RELEASE Ironwood Contact: Forest Contact: Susan Brady Frank J. Murdolo Corporate Communications Vice President, Investor Relations 617.621.8304 212.224.6714 sbrady@ironwoodpharma.com frank.murdolo@frx.com
More informationSynergy Pharmaceuticals TRULANCE (Plecanatide) Receives U.S. FDA Approval for the Treatment of Adults with Chronic Idiopathic Constipation
January 19, 2017 Synergy Pharmaceuticals TRULANCE (Plecanatide) Receives U.S. FDA Approval for the Treatment of Adults with Chronic Idiopathic Constipation NEW YORK--(BUSINESS WIRE)-- Synergy Pharmaceuticals
More informationADAPTIMMUNE INVESTOR PRESENTATION. August 2016
ADAPTIMMUNE INVESTOR PRESENTATION August 2016 DISCLAIMER This presentation contains forward-looking statements, as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA),
More informationDynavax Corporate Presentation
Dynavax Corporate Presentation Forward-Looking Statements This presentation contains forward-looking statements, including statements regarding our HEPLISAV-B TM regulatory submissions, product profile,
More informationPATENCY-1 Top-Line Results
PATENCY-1 Top-Line Results December 13, 2016 2016 Proteon Therapeutics, Inc. Cautionary Note Regarding Forward-Looking Statements This presentation contains statements that are, or may be deemed to be,
More informationPhase 2b/3 Topline Trial Results
Phase 2b/3 Topline Trial Results RP-G28 For the Treatment of Lactose Intolerance March 2017 Forward - Looking Statement To the extent that statements contained in this presentation are not descriptions
More informationUBS Global Healthcare Conference May 19, 2014
UBS Global Healthcare Conference May 19, 2014 Safe Harbor Statement This presentation may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section
More informationSunesis Pharmaceuticals Reports Second Quarter 2011 Financial Results
Investor and Media Inquiries: David Pitts Argot Partners 212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc. 650-266-3717 Sunesis Pharmaceuticals Reports Second Quarter 2011 Financial Results SOUTH
More informationCorporate Presentation August 6, 2015
Corporate Presentation August 6, 2015 Creating the Next Generation of CNS Drugs Forward-Looking Statement This presentation contains forward-looking statements. These statements relate to future events
More informationMerrill Lynch's Global Pharmaceutical, Biotechnology, and Medical Device Conference. February 7, 2007
Merrill Lynch's Global Pharmaceutical, Biotechnology, and Medical Device Conference February 7, 2007 Information related to forward-looking statements This presentation includes forward-looking statements
More informationDavid Zaccardelli, PharmD Chief Executive Officer. J.P. Morgan 37 th Annual Healthcare Conference January 8, 2019
David Zaccardelli, PharmD Chief Executive Officer J.P. Morgan 37 th Annual Healthcare Conference January 8, 2019 Disclaimer Certain information contained in this presentation relates to or is based on
More informationAvenue Therapeutics, Inc. May 2017
Avenue Therapeutics, Inc. May 2017 Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward looking statements within the meaning of the safe
More informationOncology Therapeutics without Compromise APRIL 2011
Oncology Therapeutics without Compromise APRIL 2011 Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties, including among other
More informationAvenue Therapeutics, Inc. September 2016
Avenue Therapeutics, Inc. September 2016 Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward looking statements within the meaning of the
More informationINVESTOR PRESENTATION
INVESTOR PRESENTATION May 2018 2 FORWARD-LOOKING INFORMATION The following presentation contains statements that are considered forward-looking information ( FLI ) within the meaning of securities regulation.
More informationXARACOLL Phase 3 Results Webcast. MATRIX 1 and MATRIX 2 Clinical Trials May 25, 2016
XARACOLL Phase 3 Results Webcast MATRIX 1 and MATRIX 2 Clinical Trials May 25, 2016 Forward Looking Statements This presentation contains forward-looking statements about our ongoing development of XARACOLL
More informationAugust 7, Q Financial Results
August 7, 2018 Q2 2018 Financial Results 1 Agenda Today s Speakers Paul Cox, Senior Director, Investor Relations Jeff Jonas, M.D., Chief Executive Officer Steve Kanes, M.D., Ph.D., Chief Medical Officer
More informationDiagnostics for the early detection and prevention of colon cancer. Publication of DeeP-C Study Data in New England Journal of Medicine March 2014
Diagnostics for the early detection and prevention of colon cancer Publication of DeeP-C Study Data in New England Journal of Medicine March 2014 Safe Harbor Statement Certain statements made in this presentation
More informationIdenix Pharmaceuticals Building a Leading Antiviral Franchise. Cowen & Company 27 th Annual Healthcare Conference March 13, 2007 Boston
Idenix Pharmaceuticals Building a Leading Antiviral Franchise Cowen & Company 27 th Annual Healthcare Conference March 13, 2007 Boston Safe Harbor This presentation includes forward-looking statements
More informationInvestor Presentation March 2015
Investor Presentation March 2015 1 Safe Harbor Statement This presentation and other matters discussed today or answers that may be given to questions asked include forward-looking statements within the
More informationInovio Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event
More informationBioCryst Pharmaceuticals
BioCryst Pharmaceuticals Jefferies 2010 Global Life Sciences Conference New York Stuart Grant Senior Vice President & Chief Financial Officer Rob Bennett Executive Director, Investor Relations & Business
More informationQ3 18 Earnings Supplemental Slides
(Nasdaq: INSY) Q3 18 Earnings Supplemental Slides November 5, 2018 Safe-Harbor Statement This presentation contains both historical information and forward-looking statements. Forward-looking statements
More informationDeveloping & Commercializing Targeted Small Molecule Drugs in Cancer
Developing & Commercializing Targeted Small Molecule Drugs in Cancer SAFE HARBOR STATEMENT 2 Forward-looking statements made in the course of this presentation are made pursuant to the safe harbor provisions
More informationPROMISE 1 Top-Line Data Results. June 27, 2017
PROMISE 1 Top-Line Data Results dd June 27, 2017 Forward Looking Statements This presentation and the accompanying commentary contains certain forward-looking statements within the meaning of Section 27A
More informationTargeting and Treating Cancer
Targeting and Treating Cancer Mark R. Baker, Chief Executive Officer Jefferies 2016 DISCLOSURE NOTICE This presentation may contain projections and other forward-looking statements regarding future events.
More informationCommitted to Transforming the Treatment Paradigm for Migraine Prevention
Committed to Transforming the Treatment Paradigm for Migraine Prevention 36th Annual J.P. Morgan Healthcare Conference January 8, 2018 Forward-Looking Statements This presentation and the accompanying
More informationHALOZYME REPORTS SECOND QUARTER 2018 RESULTS
Contacts: Robert H. Uhl Managing Director Westwicke Partners, LLC 858-356-5932 robert.uhl@westwicke.com Laurie Stelzer 858-704-8222 ir@halozyme.com FOR IMMEDIATE RELEASE HALOZYME REPORTS SECOND QUARTER
More information35 th Annual J.P. Morgan Healthcare Conference
35 th Annual J.P. Morgan Healthcare Conference Forward Looking Statement This presentation includes forward-looking statements. All statements, other than statements of historical facts, regarding management's
More informationHTX-011 Postoperative Pain Program Topline Results From Phase 3. March 19, 2018
HTX-011 Postoperative Pain Program Topline Results From Phase 3 March 19, 2018 Forward-Looking Statements This presentation contains "forward-looking statements" as defined by the Private Securities Litigation
More informationBDSI Corporate Overview
BDSI Corporate Overview June 2017 1 2017 BioDelivery Sciences International Inc. All Rights Reserved. Jefferies 2017 Healthcare Conference Dr. Mark A. Sirgo President and Chief Executive Officer June 6
More informationDARA Reports Year-End 2012 Financial Results
April 1, 2013 DARA Reports Year-End 2012 Financial Results Company Provides a Commercial Portfolio and Development Pipeline Business Update RALEIGH, NC -- (MARKETWIRE) -- 04/01/13 -- DARA BioSciences,
More informationJefferies Healthcare Conference
Jefferies Healthcare Conference June 7, 2016 NASDAQ: CHMA Forward-Looking Statements These slides contain forward-looking statements and information. The use of words such as may, might, will, should,
More informationCommitted to Transforming the Treatment Paradigm for Migraine Prevention
June 14, 2018 Committed to Transforming the Treatment Paradigm for Migraine Prevention September 6, 2018 Forward-Looking Statements This presentation and the accompanying commentary contains certain forward-looking
More informationMemory Pharmaceuticals Establishes Plans for Clinical Program for MEM 3454 in Schizophrenia. -Broadens Roche Nicotinic Alpha-7 Alliance-
Memory Pharmaceuticals Establishes Plans for Clinical Program for MEM 3454 in Schizophrenia -Broadens Roche Nicotinic Alpha-7 Alliance- -Secures Additional $5M Debt Financing to Support Phase 2a Trial-
More informationPress Release. RedHill Biopharma Announces Enrollment of Last Patient in the BEKINDA Phase II Study for IBS-D
Press Release RedHill Biopharma Announces Enrollment of Last Patient in the BEKINDA Phase II Study for IBS-D Top-line results are expected in the third quarter of 2017 The randomized, double-blind, placebo-controlled
More informationAVENUE THERAPEUTICS, INC. NASDAQ: ATXI NOV 2018
AVENUE THERAPEUTICS, INC. NASDAQ: ATXI NOV 2018 Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward-looking statements within the meaning
More informationObsEva Reports Third Quarter 2018 Financial Results and Provides Business Update
ObsEva Reports Third Quarter 2018 Financial Results and Provides Business Update IMPLANT 4 trial of nolasiban in IVF starting in Q4 2018, European MAA filing expected late 2019 24-week data from Phase
More informationSPHERIX ANNOUNCES FIRST QUARTER 2010 FINANCIAL RESULTS
SPHERIX Investor Relations Phone: (301) 897-2564 Email: info@spherix.com SPHERIX ANNOUNCES FIRST QUARTER 2010 FINANCIAL RESULTS BETHESDA, MD, May 21, 2010 - Spherix Incorporated (NASDAQ CM: SPEX), an innovator
More information34 th Annual J.P. Morgan Healthcare Conference
JANUARY 2016 34 th Annual J.P. Morgan Healthcare Conference [ 1 ] Forward Looking Statements SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS In addition to historical information, this presentation contains
More informationCreating a Leading Global HBV Therapeutics Company. ARB-1467 Update Call December 12, 2016
Creating a Leading Global HBV Therapeutics Company ARB-1467 Update Call December 12, 2016 NASDAQ: ABUS www.arbutusbio.com Forward Looking Statements This presentation contains forward-looking statements
More informationMedicines that make a difference
Medicines that make a difference 11 th Annual Needham Healthcare Conference Mathai Mammen, M.D., Ph.D. Senior Vice President, Research and Early Clinical Development April 4, 2012 Theravance, Theravance
More informationImpact of a Pharmacist Implemented Protocol on Overall Use of Alvimopan (Entereg ) and Length of Stay in Laparoscopic Colorectal Surgeries
Journal of Pharmacy and Pharmacology 4 (2016) 521-525 doi: 10.17265/2328-2150/2016.10.001 D DAVID PUBLISHING Impact of a Pharmacist Implemented Protocol on Overall Use of Alvimopan (Entereg ) and Length
More informationAvenue Therapeutics, Inc. August 2016
Avenue Therapeutics, Inc. August 2016 Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward looking statements within the meaning of the safe
More informationInvestor Presentation
Investor Presentation February 2018 2 FORWARD-LOOKING INFORMATION The following presentation contains statements that are considered forward-looking information ( FLI ) within the meaning of securities
More informationClovis Oncology Announces Q Operating Results and Corporate Update. November 3, :05 PM ET
Clovis Oncology Announces Q3 2016 Operating Results and Corporate Update November 3, 2016 4:05 PM ET Rucaparib New Drug Application (NDA) accepted for Priority Review in the treatment of advanced BRCA-mutant
More informationCorporate Presentation Asia Investment Series March 2018
Corporate Presentation Asia Investment Series March 2018 Safe Harbor Statement Factors Affecting Future Performance This presentation contains "forward-looking" statements within the meaning of the United
More informationN A S D A Q : E V F M
N A S D A Q : E V F M Jefferies Global Healthcare Conference June 7, 2018 Disclaimer This presentation contains forward looking statements within the meaning of The Private Securities Litigation Reform
More informationJ.P. Morgan Healthcare Conference
J.P. Morgan Healthcare Conference Shire plc January 10, 2012 Angus Russell Chief Executive Officer Our purpose We enable people with life-altering conditions to lead better lives. THE SAFE HARBOR STATEMENT
More informationSupernus Pharmaceuticals
Supernus Pharmaceuticals Jefferies 2016 Healthcare Conference May 2016 1 Safe Harbor Statement This presentation and other matters discussed today or answers that may be given to questions asked include
More informationTargeting and Treating Cancer
Targeting and Treating Cancer Mark R. Baker, Chief Executive Officer Jefferies Healthcare Conference June 2015 Disclosure Notice This presentation may contain projections and other forward-looking statements
More informationNational Horizon Scanning Centre. Methylnaltrexone (MOA-728) for postoperative ileus. April 2008
(MOA-728) for postoperative ileus April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement
More informationThird Quarter 2018 Financial Results. November 1, 2018
Third Quarter 2018 Financial Results November 1, 2018 Agios Conference Call Participants Prepared Remarks Introduction RENEE LECK, Associate Director, Investor Relations Business Highlights & 2018 Key
More informationPhotocure ASA Executing the Strategy
Photocure ASA Executing the Strategy DECEMBER 6, 2012 KJETIL HESTDAL, CEO Disclaimer The information included in this Presentation contains certain forward-looking statements that address activities, events
More informationLauren Silvernail, CFO & VP Corporate Development to present at 2005 Thomas Weisel Partners Healthcare Conference on September 7, 2005 at 3:50 pm EST
Lauren Silvernail, CFO & VP Corporate Development to present at 2005 Thomas Weisel Partners Healthcare Conference on September 7, 2005 at 3:50 pm EST Forward Looking Statements Certain statements contained
More informationCredit Suisse 27 th Annual Healthcare Conference
CHANGING THE COURSE OF HUMAN HEALTH THROUGH BOLD PURSUITS IN SCIENCE Credit Suisse 27 th Annual Healthcare Conference November 14, 2018 Forward-Looking Statements and Adjusted Financial Information This
More informationCorporate Overview. February 2018 NASDAQ: CYTR
Corporate Overview February 2018 NASDAQ: CYTR CytRx Safe Harbor Statement THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE CERTAIN RISKS AND UNCERTAINTIES. ACTUAL RESULTS COULD DIFFER
More informationCalliditas Therapeutics Q2 Report Webcast August 16, 2018, 10:00 Presenters: Renée Aguiar-Lucander, CEO Fredrik Johansson, CFO
Calliditas Therapeutics Q2 Report 2018 Webcast August 16, 2018, 10:00 Presenters: Renée Aguiar-Lucander, CEO Fredrik Johansson, CFO Disclaimer Important information This presentation may contain certain
More informationASCEND Phase 2 Trial of AXS-05 in MDD Topline Results Conference Call
NASDAQ: AXSM ASCEND Phase 2 Trial of in MDD Topline Results Conference Call January 7, 2019 Overview in MDD ASCEND Phase 2 Trial Topline Results Introduction Mark Jacobson, Senior Vice President, Operations
More informationFuture Leaders in the Biotech Industry. Lee Bendekgey, SVP, CFO & General Counsel April 7, 2005
Future Leaders in the Biotech Industry Lee Bendekgey, SVP, CFO & General Counsel April 7, 2005 Safe Harbor This presentation contains "forward-looking statements" regarding potential use of Nuvelo clinical
More information37 th Annual J.P. Morgan Healthcare Conference. January 9, 2019
37 th Annual J.P. Morgan Healthcare Conference January 9, 2019 Forward Looking Statement This presentation includes forward-looking statements. All statements, other than statements of historical facts,
More informationDeveloping treatment options for patients with rare gastrointestinal and endocrine disorders and unmet medical need
Developing treatment options for patients with rare gastrointestinal and endocrine disorders and unmet medical need Luke Beshar, senior vice president and chief financial officer BioNJ BioPartnering 2011
More informationPhotocure ASA Executing the Strategy
Photocure ASA Executing the Strategy NOVEMBER 2012 ERIK DAHL, CFO KATHLEEN DEARDORFF, COO Disclaimer The information included in this Presentation contains certain forward-looking statements that address
More informationOppenheimer 29th Annual Healthcare Conference Mark Timney, Chief Executive Officer
Oppenheimer 29th Annual Healthcare Conference Mark Timney, Chief Executive Officer New York City 20th March 2019 1 Safe Harbor Forward-looking statements Statements contained in this presentation about
More informationSavient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference
Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference EAST BRUNSWICK, N.J., Oct 27, 2008 /PRNewswire-FirstCall
More informationInfinity Highlights Promising Preclinical Hedgehog Data and Announces First Quarter Financial Results
Infinity Highlights Promising Preclinical Hedgehog Data and Announces First Quarter Financial Results Heat Shock Protein 90 Program Continues to Advance Toward Potential Registration Trial CAMBRIDGE, Mass.,
More informationAnti-IL-33 (ANB020) Program
Anti-IL-33 (ANB020) Program Phase 2a Peanut Allergy Clinical Trial Interim Data Update March 26 th 2018 NASDAQ: ANAB Safe Harbor Statement This presentation and the accompanying oral presentation contain
More informationQ1 Results 2018 Webcast presentation 26 April 2018
Q1 Results 2018 Webcast presentation 26 April 2018 Disclaimer This presentation contains forward-looking statements, including (without limitation) statements concerning the progress of our clinical pipeline,
More informationMay 10, 2016 Q & Business Update
May 10, 2016 Q1 2016 Thank Financial you Results & Business Update Q1 2016 Financial Results Prepared Remarks Q1 Update Tom Hughes, Ph.D., Chief Executive Officer Clinical Update Dennis Kim, M.D., Chief
More informationObsEva Reports First Quarter 2018 Financial Results and Provides Business Update
ObsEva Reports First Quarter 2018 Financial Results and Provides Business Update -Key First Quarter 2018 Clinical Milestones Achieved Patient randomization completed in Phase 2b EDELWEISS trial of OBE2109
More informationEmisphere Technologies, Inc. Announces 2008 Second Quarter Financial Results
August 11, 2008 Emisphere Technologies, Inc. Announces 2008 Second Quarter Financial Results Conference Call/Webcast to be Held Monday, August 11 at 10:00 AM EDT CEDAR KNOLLS, N.J., Aug 11, 2008 /PRNewswire-FirstCall
More informationCorporate overview. September Exploring innovative solutions for acute pain
Corporate overview September 2017 Exploring innovative solutions for acute pain Forward-looking statements This presentation contains forward-looking statements, including, but not limited to, statements
More informationAVEO and Astellas Report Final Overall Survival Results from TIVO-1
AVEO and Astellas Report Final Overall Survival Results from TIVO-1 - Median Overall Survival of 28.8 Months Reported for Tivozanib in Patients with Advanced Kidney Cancer - CAMBRIDGE, Mass. and TOKYO,
More informationWARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
June 5, 2018 Synergy Pharmaceuticals Highlights New Data at Digestive Disease Week (DDW) 2018 Linking Uroguanylin Deficiency to Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation
More informationDiagnostics for the early detection and prevention of colon cancer. Fourth-Quarter 2014 Earnings Call February 24, 2015
Diagnostics for the early detection and prevention of colon cancer Fourth-Quarter 2014 Earnings Call February 24, 2015 Safe Harbor Statement Certain statements made in this presentation contain forward-looking
More informationPress Release. RedHill Biopharma Provides Update on BEKINDA Ongoing Phase III Study for Gastroenteritis and Announces Planned Phase II Study for IBS-D
Press Release RedHill Biopharma Provides Update on BEKINDA Ongoing Phase III Study for Gastroenteritis and Announces Planned Phase II Study for IBS-D Based on recent U.S. FDA feedback and prior feedback
More informationSAKURA 3 Open-Label Phase 3 Safety Study with DaxibotulinumtoxinA for Injection (RT002) for the Treatment of Moderate to Severe Glabellar Lines
SAKURA 3 Open-Label Phase 3 Safety Study with DaxibotulinumtoxinA for Injection (RT002) for the Treatment of Moderate to Severe Glabellar Lines Presented by Dan Browne, Co-Founder, President & CEO, and
More informationFirst self-administered antibody therapy for HIV in late-stage clinical trials. CytoDyn Annual Meeting of Stockholders August 24, 2017
First self-administered antibody therapy for HIV in late-stage clinical trials CytoDyn Annual Meeting of Stockholders August 24, 2017 (OTCQB: CYDY) www.cytodyn.com Forward-Looking Statements This presentation
More informationAM-125 : Intranasal Betahistine
AM-125 : Intranasal Betahistine February 3, 2017 NASDAQ: EARS Forward-looking Statements This presentation and the accompanying oral commentary contain forward-looking statements that involve substantial
More informationPrucalopride (SHP555) Update for Global Investors
Prucalopride (SHP555) Update for Global Investors March 7, 2018 Prucalopride - Introduction U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation (CIC) Prucalopride
More informationAradigm Corporation. A respiratory specialty pharmaceutical company fulfilling unmet needs in pulmonary medicine (ARDM) February 2008
Aradigm Corporation A respiratory specialty pharmaceutical company fulfilling unmet needs in pulmonary medicine (ARDM) February 2008 Safe Harbor Statement This presentation contains forward-looking statements
More informationSucampo Pharmaceuticals, Inc. Jefferies 2015 Healthcare Conference
Sucampo Pharmaceuticals, Inc. Jefferies 2015 Healthcare Conference June 3, 2015 Peter Greenleaf Chief Executive Officer Forward-Looking Statements This presentation contains "forward-looking statements"
More informationUCB announces first presentation of primary data from latest Phase 3 study evaluating brivaracetam
UCB announces first presentation of primary data from latest Phase 3 study evaluating brivaracetam as adjunctive treatment of partial-onset seizures in epilepsy Primary efficacy and safety data from the
More informationAVEO and Astellas Announce TAURUS Patient Preference Clinical Study Comparing Tivozanib with Sunitinib in First-Line Kidney Cancer
FOR IMMEDIATE RELEASE AVEO and Astellas Announce TAURUS Patient Preference Clinical Study Comparing Tivozanib with Sunitinib in First-Line Kidney Cancer Study designed to build upon safety profile demonstrated
More informationNASDAQ: ZGNX. Company Presentation. October 2017
NASDAQ: ZGNX Company Presentation October 2017 2 Forward Looking Statement Zogenix cautions you that statements included in this presentation that are not a description of historical facts are forward-looking
More informationNovartis announces Phase III STRIVE data published in NEJM demonstrating significant and sustained efficacy of erenumab in migraine prevention
Novartis International AG Novartis Global Communications CH-4002 Basel Switzerland http://www.novartis.com MEDIA RELEASE COMMUNIQUE AUX MEDIAS MEDIENMITTEILUNG Novartis announces Phase III STRIVE data
More informationConference Call for Investment Community. Nov 19, 2018
Conference Call for Investment Community Nov 19, 2018 Agenda for Today s Call Topic Safe Harbor Statement Opening Remarks AR101 for Peanut Allergy Speaker Laura Hansen, PhD, VP, Investor Relations Jayson
More informationCorporate overview. December Exploring innovative solutions for acute pain
Corporate overview December 2017 Exploring innovative solutions for acute pain Forward-looking statements This presentation contains forward-looking statements, including, but not limited to, statements
More informationTheravance Biopharma, Inc. (NASDAQ: TBPH)
Theravance Biopharma, Inc. (NASDAQ: TBPH) FDA Approval of YUPELRI TM (revefenacin) Inhalation Solution November 9, 2018 THERAVANCE and the Cross/Star logo are registered trademarks of the Theravance Biopharma
More informationBuilding a Fully Integrated Biopharmaceutical Company. June 2014
Building a Fully Integrated Biopharmaceutical Company June 2014 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation
More informationNew SEL-212 Phase 2 Data Presented at EULAR. June 15, 2018
New SEL-1 Phase Data Presented at EULAR June 15, 1 Safe Harbor / Disclaimer Any statements in this presentation about the future expectations, plans and prospects of Selecta Biosciences, Inc. ( the company
More informationDetermined to realize a future in which people with cancer live longer and better than ever before Q Conference Call
Reimagining Cancer Treatment Determined to realize a future in which people with cancer live longer and better than ever before Q1 2016 Conference Call 1 Forward-Looking Statements Disclosure This presentation
More information- Plans Commercial Launch of three dosing options for Excellagen in pre-filled syringes
Generex Biotechnology Subsidiary Olaregen Therapeutix Inc. Plans Launch of FDA Cleared Excellagen Wound Conforming Gel Matrix with Three Dosage Options - Plans Commercial Launch of three dosing options
More informationUSPSTF Draft Recommendations Investor Call. October 6, 2015
USPSTF Draft Recommendations Investor Call October 6, 2015 v Safe Harbor Statement Certain statements made in this presentation contain forward-looking statements within the meaning of Section 27A of the
More informationValneva Reports Strong 2017 Revenues Driven by Double Digit Product Sales Growth
Valneva Reports Strong 2017 Revenues Driven by Double Digit Product Sales Growth Strong sales performance in 2017 (unaudited) Total revenues of 109.8 million in 2017 (2016-97.9 million) representing year-on-year
More informationForward-Looking Statements
Investor Presentation May 2012 Forward-Looking Statements Statements contained herein that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended.
More information