Rocket Pharmaceuticals Announces Participation at the Bank of America Merrill Lynch 2019 Healthcare Conference

On May 7, 2019 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a leading U.S.-based multi-platform clinical-stage gene therapy company, reported that Gaurav Shah, M.D., Chief Executive Officer and President of Rocket is scheduled to present on Wednesday, May 15, 2019, at 3:40p.m. Pacific Time at the Bank of America Merrill Lynch 2019 Healthcare Conference in Las Vegas, Nevada (Press release, Rocket Pharmaceuticals, MAY 7, 2019, View Source [SID1234535847]).

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Gaurav Shah, M.D. will also participate in a Gene Therapy Panel on Wednesday, May 15, 2019, at 4:20p.m. Pacific Time

A live audio webcast of the presentation will be available on the Investors section of the company’s website, www.rocketpharma.com. A replay of the presentation will be archived on the Rocket website following the conference.

Adamis Pharmaceuticals Schedules First Quarter 2019 Earnings Conference Call and Business Update

On May 7, 2019 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) ("Adamis"), a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas including respiratory disease and allergy, reported that it will host an investor conference call on Thursday, May 9, 2019 at 2:00 pm Pacific Time to discuss its financial and operating results for the first quarter of 2019 as well as provide an update on business developments and activities (Press release, Adamis Pharmaceuticals, MAY 7, 2019, View Source [SID1234535846]). The company’s press release concerning its first quarter 2019 financial results will be available after 1:00 p.m. Pacific time on May 9, 2019, on its website at www.adamispharmaceuticals.com , and the company also expects to file its quarterly report on Form 10-Q for the first quarter ended March 31, 2019, on that date.

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Event: Adamis Pharmaceuticals First Quarter 2019 Conference Call

Date:Thursday, May 9, 2019

Time:2:00 pm PT (5:00 pm ET)

US Dial-in (Toll Free): 1-800-458-4148

TOLL/International Dial-in: 1-323-794-2597

Conference ID: 1311319

Dr. Dennis J. Carlo, President and CEO of Adamis, will host the call along with other members of the management team. The call is open to the public and will provide an update on recent developments, events that have taken place during this quarter and certain target milestones and goals for future periods. Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

A live audio webcast of the conference call will also be available via this link – View Source Participants should access this webcast site 10 minutes before the start of the call. In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on May 9, 2019. To listen to the replay, call toll free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay PIN number 1311319.

CohBar Appoints Steven B. Engle as Chief Executive Officer

On May 7, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases and extend healthy lifespan, reported that it has appointed Steven B. Engle as its Chief Executive Officer, effective May 15, 2019 (Press release, CohBar, MAY 7, 2019, View Source [SID1234535845]). CohBar’s interim Chief Executive Officer Dr. Philippe Calais will continue to serve on the company’s Board, a position he has held since June 2018.

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"Steven is a highly accomplished healthcare executive, and we are very happy to have him leading the CohBar team at this important time in the company’s evolution," said Albion J. Fitzgerald, Chairman of the Board of Directors. "With our phase 1a/1b clinical trial of CB4211 in NASH and obesity, and our expanding pipeline of mitochondrial-derived peptides that hold great promise as a new class of novel therapeutics, we believe we are well positioned to become a leader in the development of therapeutics to treat a broad range of age-related diseases. We expect that Steven’s extensive experience in drug discovery, development and commercialization, together with his track record of executing value-creating strategic transactions, will be instrumental in leading the company toward achieving our corporate and clinical goals."

"On behalf of the Board, I would like to thank Philippe for his dedication, contributions and leadership during this transition. We look forward to his continued contributions as a valued member of our Board," Mr. Fitzgerald concluded.

"I am very pleased to be working with the CohBar Board, executive management and the broader team to realize the company’s vision to develop mitochondria based therapeutics that treat chronic diseases with underlying metabolic dysfunction," commented Mr. Engle. "This is an exciting time for CohBar, and I look forward to our advancing the company’s novel pipeline through value-creating milestones."

Steven Engle has over 20 years of executive leadership experience with public biotech companies developing breakthrough products in metabolic, autoimmune, oncologic and infectious disease areas. Before joining CohBar, Mr. Engle served for seven years as CEO of Averigon Consulting, an advisory firm to the life science industry, supporting companies through product partnering, regulatory planning, investor relations and executive management. Previously, he served for four years as Chairman and CEO of XOMA Corporation, a leader in therapeutic antibodies and antibody technologies. Prior to XOMA, Mr. Engle served for fourteen years as Chairman and CEO of La Jolla Pharmaceutical Company, which discovered the biology of B cell tolerance, developed the first B cell toleragen for lupus patients, and received an approvable letter from the FDA. Earlier, he also served as Vice President of Marketing for Cygnus, Inc., a drug delivery systems company, where he helped to gain FDA approval and to launch Nicotrol for smoking cessation.

Mr. Engle is Chairman of the Board of Prescient Therapeutics Ltd., a clinical stage oncology company, and also serves on the Boards of Author-it Software Corporation, and AROA Biosurgery Ltd. He is a former director of BIO, BayBio and BIOCOM, and served on the board of the Lupus Foundation of America. Mr. Engle holds M.S.E.E. and B.S.E.E. degrees from the University of Texas with a focus in biomedical engineering.

About CB4211

CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. In July 2018, CB4211 entered a Phase 1a/1b clinical trial which includes a potential activity readout relevant to NASH and obesity. In November 2018, the company announced the temporary suspension of the trial to address mild injection site reactions that were unexpectedly persistent, and announced the anticipated resumption of the clinical trial in May 2019. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.

AbbVie to Present at the Bank of America Merrill Lynch Healthcare Conference

On May 7, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the Bank of America Merrill Lynch Healthcare Conference on Wednesday, May 15, 2019 (Press release, AbbVie, MAY 7, 2019, View Source [SID1234535844]). Michael Severino, vice chairman and president, will present at 3:00 p.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

Aeglea BioTherapeutics Reports First Quarter 2019 Financial Results and Corporate Highlights

On May 7, 2019 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that engineers next generation human enzymes to provide solutions for diseases with unmet medical need, reported financial results for the first quarter ended March 31, 2019 and corporate highlights (Press release, Aeglea BioTherapeutics, MAY 7, 2019, View Source [SID1234535843]).

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"Aeglea built on its momentum from 2018 with a terrific start to the year, including the presentation of new compelling clinical data from the Phase 1/2 trial of pegzilarginase for Arginase 1 Deficiency," said Anthony G. Quinn, M.B Ch.B, Ph.D., president and chief executive officer. "We see marked and sustained reductions in plasma arginine in all patients with clinically meaningful improvements in mobility and adaptive behavior. We believe the emergent data from this trial reaffirms the design of our upcoming pivotal Phase 3 PEACE trial, with first patient dosing on track for this quarter."

Corporate Highlights

Pegzilarginase in Arginase 1 Deficiency: Continued progress towards commercialization of the Company’s lead program

Aeglea presented new positive Phase 1/2 data for pegzilarginase in patients with Arginase 1 Deficiency (ARG1-D) at the 2019 Annual Meeting of the Society for Inherited Metabolic Disorders (SIMD). The oral presentation was delivered by Dr. George Diaz, M.D., Ph.D., Division Chief of Medical Genetics in the Department of Genetics and Genomic Sciences at the Icahn School of Medicine at Mt. Sinai, New York, NY, and a Principal Investigator on the pegzilarginase Phase 1/2 trial. Highlights of the presentation included the following:

Plasma arginine reduction was statistically significant (p<0.001) at eight weeks with sustained control through longer-term dosing.
Five of five (100%) and eight of 14 (57%) patients showed overall clinical response (mobility or adaptive behavior) at 20 weeks and eight weeks, respectively. Clinical responses were effectively captured using mobility and adaptive behavior assessments.
Pegzilarginase was generally well tolerated. Serious adverse events included hypersensitivity and hyperammonemia. Hypersensitivity reactions were infrequent, managed with standard treatment and did not lead to any patient discontinuations.
Upcoming Events

Aeglea will present at the following conferences, with details regarding the date and time of the presentations and webcasts to be announced prior to the events.

Jefferies 2019 Healthcare Conference to be held June 4-7 in New York, NY.
BMO 2019 Prescriptions for Success Healthcare Conference to be held June 25 in New York, NY.
First Quarter 2019 Financial Results

As of March 31, 2019, Aeglea had available cash, cash equivalents and marketable securities of $123.7 million. Based on Aeglea’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations through the first quarter of 2021.

Research and development expenses totaled $14.4 million for the first quarter of 2019, compared with $6.9 million for the first quarter of 2018. The increase was primarily due to expanded clinical development activity, investment in manufacturing and pre-commercial activities for Aeglea’s lead product candidate, pegzilarginase, and a ramp-up in manufacturing activities for our Homocystinuria program.

General and administrative expenses totaled $3.3 million for the first quarter of 2019, compared with $2.9 million for the first quarter of 2018. This increase was primarily due to additional employee headcount and compensation to support company growth.

Net loss totaled $17.2 million and $8.1 million for the first quarter of 2019 and 2018, respectively, with non-cash stock compensation expense of $1.1 million and $0.8 million for the first quarter of 2019 and 2018, respectively.

About Pegzilarginase in Arginase 1 Deficiency

Pegzilarginase is an enhanced human arginase that enzymatically depletes the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency, a rare debilitating disease presenting in childhood with persistent hyperargininemia, severe progressive neurological abnormalities and early mortality. Pegzilarginase is intended for use as an enzyme replacement therapy in patients to reduce elevated blood arginine levels. Aeglea’s Phase 1/2 data for pegzilarginase in patients with Arginase 1 Deficiency demonstrated clinical improvements and sustained lowering of plasma arginine. The Company intends to initiate its single, global pivotal Phase 3 PEACE trial designed to assess the effects of treatment with pegzilarginase versus placebo over 24 weeks with a primary endpoint of plasma arginine reduction.