EpiQuell™: The Future of Anti-Infectives

Sept. 11, 2017

Other conferences being attended through end of 2017:

• Chief Business Officer, Jeffrey Travis, PhD will be a presenter at the BioPharm America conference on September 26-27 in Boston.
• CEO, Alex Huang will be a presenter in the 2017 BIO Investor Forum taking place in San Francisco on October 17-18.
• Chief Business Officer, Jeffrey Travis, PhD will be a presenter Bionetwork Partnering Summit. Laguna Nigel, California on October 23-25

September 10, 2017

Quellthera CEO, Alex Huang will be a panelist on “The New Wave of Anti-Infectives: MicroBiome & Immunotherapy” at the 2017 Anti-Infectives Rx conference taking place at Harvard Medical School on September 18. Other panelists will include Steven Gilman, Chairman, ContraFect; Alex Huang, CEO, Quellthera; Lee Jones, President & CEO, Rebiotix; Deborah O’Neil, CEO, NovaBiotics; Chris Stevens, Chief Medical Officer, Arsanis
Moderator: Bernat Olle, CEO, Vedanta Biosciences.

August 9, 2017

Quellthera will be a silver sponsor and presenter at the VIP dinner of the 5th annual Cdiff international Awareness Conference and Awareness Expo, November 9-10, in Las Vegas, Nevada.

August 1, 2017

FDA response to Quellthera’s Pre-IND meeting lays out clear IND path directly into Phase 2 clinical trial under the FDA’s extensively revised Botanical Drug Development Guidance for Industry, 2016. Quellthera will be able to leverage CMC and safety record from the company’s prior non-pharmaceutical versions of what is now designated EPQ-100. The FDA response also recommended pediatric inclusion in studies and affirmed consideration for a Special Protocol Assessment (SPA). The company anticipates submission of IND before year end and commencement of Phase 2A clinical trial in Q1, 2018.

June 15, 2017

Quellthera program plans for future growth were presented during a Stockholder Information Session held on June 15 for LiveLeaf preferred equity holders. LiveLeaf CEO, Alex Huang introduced the Quellthera team of Edward Schnipper, MD, Randy Johnson PhD, Ron Najafi PhD, Jeff Travis PhD to elaborated on their perspectives and specific roles in pursuing FDA drug approval for EPQ-100 as a C. difficile infection treatment. The well attended meeting was also an opportunity for shareholders to engage in dialog with LiveLeaf corporate counsel, Mitch Marder ; CFO, Jennifer Aichele and Grazix CEO, Zachary Wochok, PhD.

May 26, 2017

Quellthera team submits meeting request to FDA commencing the process for obtaining clinical trial permission to potentially commence phase II clinical trials before year end on the company’s lead anti-virulence compound EPQ-100 as an Investigational New Drug. The intended first indication will be Clostridium difficile infection in patients who had failed antibiotic treatment. The FDA’s recently approved Botanical Drug Development guidance is a major regulatory shift providing Quellthera a clear, streamlined regulatory path, enabling the company to leverage prior commercial use and the historical safety of the botanical components used in manufacture. “Our EpiQuell™ platform is a new pharmaceutical pro-drug concept that overcomes a fundamental stability problem that has kept natural biologic processes in plants from being refined into practical modern medicines.” according to Dr. Jeff Travis, Quellthera’s Chief Business Officer.

May 22, 2017

Quellthera, Inc., announces successful completion of testing using the EpiQuell botanical pro-drug against a panel of super resistant pathogens (so called ESKAPE pathogens) and found Quellthera’s lead drug candidate, EPQ-100 to be extremely potent against these pathogens. Data associated with this result will be presented at the upcoming Infectious Disease Society of America Conference by Quellthera’s R&D partner Emery Pharma based in Alameda, CA.

ESKAPE pathogens are: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter. C. diff infection remains a significant challenge worldwide. These pathogens are highly resistant to many antibiotics and are responsible for nearly most nosocomial hospital infections and death in the United States and are on Serious Threat Level standing by the Center for Disease Control.

Alex Huang, CEO of LiveLeaf stated, “We have known our polyphenol pro-drug has broad spectrum inhibition. This and other ongoing experiments are elucidating a powerful ability to address even the toughest infections by inhibiting the signals that trigger pathogen proliferation as opposed to trying eradicate by killing. We believe this is a major breakthrough that could revitalize an anti-infective industry that has not seen a novel class of drugs in over thirty years.”

May 3, 2017

Quellthera makes plans to have a significant display presence at the Infectious Disease Week (ID Week 2017) conference in San Diego this October 4-8. IDWeek is the combined annual meeting of the IDSA, SHEA, HIVMA, and PIDS, where infectious diseases professionals can meet, share experiences, and develop collaborations for the improvement of patient care and public health.

May 2, 2017

Quellthera’s executive leadership will be attending the upcoming Biotechnology Innovation Organization convention (BIO 2017) in San Diego, California from 19th- 22nd June, 2017 to kick off its strategic partnering efforts with engagement with several major pharmaceutical companies. The convention is typically attended by over 15,000 biotechnology and pharma leaders who come together to connect and discover new opportunities and promising partnerships. A wide range of life science and application areas like drug discovery, bio manufacturing, genomics, biofuels, cell therapy, and nanotechnology will be covered during the event.

April 15, 2017

Quellthera’s team will begin working with the Florida-based regulatory consultancy, Pharmaceutical Development Group on drug approval submissions. Dr. Cheryl Blume, founder and president of PDG brings more than 35 years of pharmaceutical industry experience, having participated in more than 150 NDAs / ANDA submission to the FDA. “PDG” largely completes the suite of required specializations including toxicologists, pharmacologists, epidemiologists, RAPS certified regulatory affairs personnel and labeling experts. According to Quellthera Chairman, Alex Huang, “We chose PDG as a highly regarded consulting group with a long, stable history of operation and a strong track record with regulatory agencies around the world. We see PDG as a highly cost effective resource with the depth to enable us to confidently expand into multiple drug programs in the future.”

April 14, 2017

Jeffrey C. Travis, Ph.D Joins Quellthera as Chief Business Officer. Dr. Travis has over 35 years of experience in entrepreneurial and large corporate executive management in the biotech/pharma, medical device/diagnostics, and clinical industries and has career-long success in development of FDA approved products. Dr. Travis was Founder, Chairman, CEO, and Director of Clinical Operations of Microanalytic Research, Inc., a pioneering diagnostics and pharma contract firm, where he developed and commercialized many FDA approved diagnostics (later acquired by ICN Pharmaceuticals). He has held executive leadership positions in operations, business development, R&D and marketing for various companies including: Enigma Diagnostics, Inc. (COO); Maven Biotechnologies (President and COO), Cryptome Pharmaceuticals Ltd. (CEO and Managing Director, Board Member) and more. He completed a post-doctorate in the Department of Clinical Pathology, City of Hope National Medical Center, before directing an Advanced Technologies Laboratory there, and is a licensed Clinical Chemist. He obtained his Ph.D. in Physiology and Neuroendocrinology from the University of California, Santa Barbara and his B.A. in Biology and Neurobiology from the University of Pennsylvania.

April 11, 2017

San Carlos, CA. – Quellthera, Inc., a biopharmaceutical company pioneering novel anti-virulence drugs to combat antibiotic resistant bacterial infection, announces research collaboration with leading contract research organization, Emery Pharma.

“Evolution has given plants an elegant means to coexist with potentially harmful bacteria without generating resistance. The biochemistry responsible for this was also part of our evolutionary diet and intrinsically safe. We have now learned to harness this to treat infection while protecting the delicate balance of human gut microflora. We look forward to leveraging Emery Pharma’s unique microbiology and analytical capabilities in creating a new generation of drugs to address the global superbug crisis. ” says Alex Huang, Founder and CEO of LiveLeaf.

“More than ever, we are in need of new approaches in dealing with multidrug resistant pathogens. Emery Pharma has the largest collection of ESKAPE pathogens for rapid drug screening in the USA. Emery Pharma’s biology and chemistry group are eager to support LiveLeaf in their development goals. ” says Ron Najafi, Ph.D., President & CEO of Emery Pharma.

About Emery Pharma

Emery Pharma (http://emerypharma.com) is a contract research organization focused on supporting mid-size biotech, pharma, synthetic fuel, agrochem and novel battery technology being developed all over the world. Emery Pharma is located in Alameda, CA (just outside of San Francisco). Emery Pharma’s experienced chemists and biologists, deploys the most modern equipment (NMR, LCMS, Prep-HPLC, ICP-MS) in support of it’s research and development collaboration partners. The team is capable of conducting organic synthesis in supporting of medicinal chemistry effort, biological screening, deformulation projects and much more. Emery Pharma can be contacted by calling 1-510-899-8814 or 1-888-98-EMERY or sending a message through it’s website: http://emerypharma.com/contact/

March 19, 2017

Quellthera engaged Mitchell Marder of Arent Fox LLP as corporate counsel. As a partner for several national and international law firms, Mitchell represented public and private emerging growth companies and venture capital investment funds in venture capital and other equity financings. He has handled a broad range of corporate and transactional matters, including venture capital financings, public offerings, mergers and acquisitions, general corporate/securities law matters, and intellectual property licensing arrangements. Mr. Marder is also the Executive Vice President, Corporate Development and Chief Legal Officer at Cytimmune Science, Inc., a Maryland-based clinical stage nanomedicine company, giving him a unique legal and executive perspective. Quellthera has been working with Arent Fox on a number of matters and has been impressed with the nimble guidance and deep industry experience.

January 10, 2017

Quellthera presents poster at the San Francisco, RESI conference, revealing its intention to pursue FDA approval for its EpiQuell™ platform as acute therapy for Clostridium difficile infection (CDI). Clostridium difficile is a leading cause of healthcare acquired infection, affecting an estimated 450,000 patients in the US each year, primarily in the elderly, but can infect all ages. Its primary risk factor is antibiotic disruption of the gut microbiome and causes severe and potentially life-threatening diarrhea and colitis. Liveleaf’s commercially available predecessor to Quellthera’s lead compound EPQ-100, had demonstrated better than 80% efficacy in physician case studies on pediatric and adult CDI patients, using diarrhea and toxin A clearance as evaluation endpoints. Many of these patients had previously failed standard antibiotic therapies. EPQ-100 has the advantage of inhibiting bacterial virulence rather than relying on anti-biotic killing, and appears to be less disruptive of the microbiome and functions through mechanisms that circumvent known drug resistance mechanisms.

December 29, 2016

The Food and Drug Administration is announcing the final adoption of a guidance for industry entitled “Botanical Drug Development.” This guidance describes FDA’s current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations for submitting investigational new drug applications (INDs) to support future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. This guidance replaces the guidance for industry entitled “Botanical Drug Products” issued in June 2004 and finalizes the August 2015 draft guidance entitled “Botanical Drug Development.” This is a monumental regulatory change for manufactures of botanical health products. It recognizes the distinction between botanical drugs with efficacy that may be the result of many natural compounds versus synthetic, purified or chemically modified drugs, including antibiotics derived from microorganisms, characterized by a specific molecule that provides clinical benefit. Previously, most botanical products were relegated to foods or ‘dietary supplements’ and not viewed as capable of treating or preventing a disease. The new FDA guidance allows manufacturers to potentially bypass much of Phase I safety evaluation for medicines made from plants with significant historical or clinical safety record.

December 11, 2016

Quellthera selected to present in the RESI Innovation Challenge on January 10 during J. P. Morgan week in San Francisco. Companies with innovative technologies and compelling proof-of-concept animal data or early stage clinical data are selected by Life Science Nation’s internal scientific review board to be part of the RESI Innovation Challenge, presenting their technologies in an exhibition-style format at the Redefining Early Stage Investments (RESI) conference. RESI is an established global circuit partnering conference for early stage life science companies, creating a global dialogue to bring products to market at a faster pace. RESI brings qualified investors from ten categories including, Family Offices, Venture Philanthropy, Patient Groups, Corporate Development, Virtual Pharma, Endowments, Foundation, and Angels. RESI also serves as an excellent opportunity for large pharma/ medtech companies and service providers to connect with attending companies and investors representing their portfolio companies.

December 2, 2016

Quellthera engages Randolph M. Johnson, Ph.D., and Nooshin Azimi, PhD to assess CMC and pre-clinical readiness as well as developing preliminary program plans for pursuing anti-infective drug indications under the FDA’s pending Botanical Drug Development guidance.

Dr. Johnson is a highly experienced Clinical Development consultant with 25+ years in drug discovery to commercialization, having delivered Herceptin®, Aloxi®, together generating over $2 Billion in annual sales and a 3rd drug Parsabiv® expecting approval in 2017. Dr. Johnson has raised over $130 Million in capital funds, filed 11 INDs, is inventor on 12 U.S. and international patents and author of over 120 scientific publications, abstracts and book chapters. Previously he has held executive positions at Cortexyme , KAI Pharmaceuticals, Cellgate and DURECT Corp; was the head of Neurobiology and Molecular and Cellular Biochemistry at Roche and directed R&D at Syntex and Genentech. Dr. Johnson was Assistant Professor of Pharmacology at University of Virginia after receiving his Ph.D. in Biomedical Sciences-Pharmacology, from the University of South Carolina, and an M.A in Biology and B.S. in Zoology.

Dr. Azimi is expert at managing Clinical Operations. Dr. Azimi has over 25 years of product development experience in pharmaceutical and medical devices, from proof-of-concept to post-launch and is responsible for multiple successful regulatory filings in U.S. and ROW throughout her career, including INDs, NDAs, BLAs, IMPDs, CTAs and 510 ks in a variety of therapeutic areas such as dermatology, oncology, diabetes, cardiovascular diseases, etc. She launched a major product (now Raptiva®) for treatment of psoriasis at Genentech, led the global team for Nartrecor® at J&J with a budget exceeding $500M, headed up project and portfolio development at Chiron and launched Freestyle® for Therasense (now Abbott).

November 15, 2016

Quellthera appoints Ramin (“Ron”) Najafi PhD. as a member of the newly formed business advisory board. Dr. Najafi is has been an accomplished entrepreneur and scientist who founded NovaBay Pharmaceuticals in 2000 to develop anti-infectives and took the company to IPO, raising over $150 million in public and private investment. He was the president and CEO of CP Lab Safety, Inc. He has also held scientific roles at Rhône Poulenc Rorer (now Sanofi-Aventis), Perkin Elmer (now Thermo Fisher), and Aldrich Chemical Company. Dr. Najafi has more than 70 patents and pending patent applications on his inventions. He received B.S. and M.S. degrees in chemistry from the University of San Francisco, and a Ph.D. in organic chemistry from the University of California at Davis.

November 12, 2016

Quellthera, Inc. announced today the appointment of Ed Schnipper, M.D., as Chief Medical Officer. Quellthera is a privately held biopharmaceutical company developing a new class of non-antibiotic anti-infectives based on its proprietary botanical pro-drug platform. Dr. Schnipper has more than 20 years of leadership experience in the clinical development of medicines for the pharmaceutical and biotechnology industries. Dr. Schnipper has been responsible for numerous clinical trial programs that resulted in successful development, approval and commercial growth for new therapeutic products in oncology and other therapeutic areas. Dr. Schnipper received his M.D. from Georgetown University, completed a Hematology fellowship at New York University and an Oncology fellowship at Sloan Kettering. He rose to Vice President at Hoffman-La Roche and Vice President, Clinical Development, at ALZA from 1997 to 2001, playing a leading role in the development and FDA approval of four of ALZA’s drugs, then served as President and CEO of Cellgate, developing novel anti-proliferative drugs where he raised over $50 million in venture capital. He also served as Executive Vice President & Chief Medical Officer of Novacea, developing therapies for the treatment of cancer, and also currently serves as managing director and chief medical officer for Velocity Pharmaceuticals.

“We are elated to have Ed join our team. His innovative drug development strategies have been proven by an extraordinary track record of the FDA approval and successful commercial launches of major drugs.” according to Alex Huang, Chairman of Quellthera.

November 8, 2016

Quellthera, Inc., a Delaware Corporation is established as a wholly owned subsidiary of San Francisco, Bay Area based LiveLeaf, Inc. Quellthera will have exclusive license to pursue FDA approvals for anti-infective and gastrointestinal drugs leveraging the intellectual property, products and clinical studies related to the novel botanical medicine platform developed by LiveLeaf. LiveLeaf founder, Alex Huang, anticipates the final approval of the FDA Botanical Drug Development guidance for industry to be pivotal in the ability to gain FDA approval for LiveLeaf’s polyphenol-based pro-drug platform, with the existing data set and commercial safety record to provide significant shortening of the drug approval timeline.

Quellthera licensed LiveLeaf’s LiveXtract platform of stable oxidant-polyphenol complexes intended for local activation in the gut by enzymes of the microbiome and injured gut lining. The resulting molecules strongly bind proteins that enable pathogenic activities while reducing evolutionary advantage for resistant survivors.

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LiveLeaf respects your privacy. To better protect your privacy, we provide this notice explaining our online information practices and the choices you can make about the way your information is collected and used. As we continue to improve our Website, our privacy policy and terms of use may be amended when appropriate to do so.

Please review the privacy policy regularly to ensure that you are familiar with our privacy practices. If you have any questions regarding our policy, please contact a representative of LiveLeaf and its subsidiaries by sending an e-mail to info@liveleaf.com.

If you have any questions or concerns about this privacy policy, please email LiveLeaf at info@liveleaf.com.