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CLENE INITIATES MULTIPLE ASCENDING DOSE PROTOCOL IN ITS PHASE 1 STUDY IN HEALTHY HUMAN VOLUNTEERS

April 16, 2016 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal therapeutics, today announced the initiation of the Phase 1b Multiple Ascending Dose clinical program for its lead asset, CNM-Au8, in healthy human volunteer subjects at the clinical research organization Centre for Human Drug Research (CHDR) in Leiden, Netherlands. In the Multiple Ascending Dose protocol, which is a blinded, randomized, placebo-controlled trial, four doses (15, 30, 60 and 90 mg as an oral suspension) of CNM-Au8 will be clinically evaluated. Each dosing cohort will undergo a mandatory safety review before progression to the next higher dosing cohort. Each subject will be treated daily for 21 consecutive days, with periodic blood collection for pharmacokinetic profiling of CNM-Au8. Clene anticipates completion of the Phase 1b Multiple Ascending Dose protocol in late 2016.

DR. CONSUELO BLOSCH JOINS CLENE AS CHIEF MEDICAL OFFICER.

April 11, 2016 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal therapuetics, today announced the retirement of its founding Chief Medical Officer, Dr. William Houghton, and the hiring of Dr. Consuelo (Glenn) Blosch, MD. Dr. Blosch has extensive experience in clinical development, drug safety, and regulatory affairs with prior industry experience at The Medicines Company (Surgery & Perioperative Care –Raplixa®/RaplixaSpray®), Amgen (Global Therapeutic Safety - Inflammation & Endocrine), VSLT, Benaroya Research Institute (Clinical Research Program), NPS Pharmaceuticals (Preotact, Gattex®), and Immunex (Soluble Receptor Progams). Dr. Blosch led the clinical development program for Enbrel for the treatment of rheumatoid arthritis and most recently, medically supported the latter stages for the global registration FDA and EMEA) program for Raplixa® /RaplixaSpray® (human fibrin sealant) at The Medicines Company. Dr. Blosch completed her residency, as Dr. Consuelo M Glenn, in pediatrics with a fellowship in nephrology at Seattle Children’s Hospital and University of Washington Medical Center in Seattle, Washington. Dr. Houghton will continue to consult with Clene as he begins his third retirement.

EU PATENT VALIDATED FOR NOVEL BI-METALLIC PLATINUM-GOLD NANOCRYSTAL.

March 21, 2016 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal therapeutics, today announced it had received validation of its novel bi-metallic platinum-gold nanocrystal patent filing with the European Patent office for the countries of Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, Liechtenstein, and the United Kingdom. The granted claims are for the novel suspensions, methods for making the novel suspensions and therapeutic uses of the same. Clene has also recently received notification of a U.S. patent grant for manufacturing and therapeutic uses of a novel silver-zinc liquid composition. These latest patent approvals add to Clene’s patent portfolio for the novel nanocrystalline suspensions, manufacturing methods and therapeutic applications of metallic nanocrystalline drug suspensions.

CLENE ANNOUNCES COMPLETION OF THE SINGLE ASCENDING DOSE PORTION OF PHASE I PROTOCOL IN HEALTHY HUMAN VOLUNTEERS.

January 18, 2016 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal medicines, today announced completion of the first Single Ascending Dose portion of its Phase 1 program in healthy volunteers. The Phase 1 Single Ascending Dose portion concluded in December 2015 with no significant adverse effects attributable to CNM-Au8. The second part of the Phase 1 study, the Multiple Ascending Dose protocol, will commence in April 2016.

CLENE SIGNS COLLABORATIVE RESEARCH AGREEMENT WITH OHSU.

December 24, 2015 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal therapeutics, today announced the signature of a collaborative research agreement with OHSU in Portland, Oregon. Under the guidance of Drs. Susan Hayflick, M.D., and Suh Young Jeong, Ph.D., OHSU will complete a series of preclinical experiments, which will explore mitochrondrial protection and the mechanism and effects of CNM-Au8 on models of mitochondrial function and its potential application to neurodegenerative diseases.

CLENE SIGNS COLLABORATIVE RESEARCH AGREEMENT WITH NORTHWESTERN UNIVERSITY.

December 9, 2015 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal therapeutics, today announced the signature of a collaborative research agreement with Northwestern University. Under the guidance of Dr. Stephen Miller, Northwestern will complete a series of preclinical experiments exploring the mechanism and effects of CNM-Au8 on oliogodendrocyte biology in myelination and demyelination models. Clene expects the data from these experiments will further understanding regarding how CNM-Au8 affects foundational cellular processes in support of myelination and may identify optimal clinical indications for treatment of demyelinating diseases for Clene’s Phase 2 clinical program.

FDA Approval to Commence Phase I Single Ascending Dose Protocol.

September 29, 2015 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced the United States Food and Drug Administration has granted approval for Clene to proceed with its Phase 1a Single Ascending Dose clinical protocol of CNM-Au8 in healthy human volunteer subjects in the United States.

Initiation of Phase I Clinical Program.

May 8, 2015 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced the initiation of its Phase Ia Single Ascending Dose clinical program in healthy human volunteer subjects at the clinical research organization Centre for Human Drug Research (CHDR) in Leiden, Netherlands. In the Single Ascending Dose protocol, four doses of CNM-Au8 are administered in conjunction with blinded, randomized placebo. Each dosing cohort will undergo a mandatory safety review before progression to the next higher dosing cohort. Each subject will be followed for seventeen days post-dosing for safety review and blood collection for pharmacokinetic profiling of CNM-Au8. Following safety and PK analyses of the Phase 1a results, Clene anticipates continuation to a Phase Ib Multiple Ascending Dose protocol in early 2016.

Close of Series A Capital Raise.

April 29, 2015 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced the close of its oversubscribed Series A Financing Round at an aggregate amount of $31.6M USD. Notably, it is Clene’s understanding this may be one of the largest non- institutional, Angel-financed raises in biopharmaceutical history. Clene is pleased by the trust and commitment of its investor group. The capital raise will be used to fund continuing operations, the Phase I clinical program for Clene’s lead asset, CNM-Au8, and further preclinical studies to more fully elucidate the mechanism(s) of action of CNM-Au8 in the treatment of demyelinating disorders such as neuromyelitis optica and/or multiple sclerosis, as well as early development of another Clene nanotherapeutic drug asset.

Clene Receives IMPD Approval; Phase I Clinical Program Planned.

April 15, 2015 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced the approval by the Netherlands’ Competent Authority for the initiation of the Phase I study in healthy human volunteer subjects for Clene’s lead asset, CNM-Au8. Clene has chosen the Centre for Human Drug Research (CHDR), a globally reputable clinical research organization located near the University of Leiden for the execution of this Phase I study. Clene plans to initiate the Phase I program later this year.

Clene Appoints Head Head of Strategic Operations.

April 1, 2015  -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced the appointment of Michael Hotchkin as Head, Strategic Operations. Michael Hotchkin has over fifteen years in the biopharmaceutical industry with diverse experiences including roles in commercial and medical affairs. Most recently, Michael led a boutique strategic consulting firm, AvantureBio LLC supporting biopharmaceutical clients. Prior to that he led Actelion Pharmaceuticals Genetics business unit with primary commercial responsibility for sales and marketing. Michael’s extensive experiences in strategic planning, business development, medical affairs, and operational planning will assist Clene’s planning activities and fund raising

Clene Files Investigational Medicinal Product Dossier For Research in the EU.

March 17, 2015 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced it had filed an Investigational Medicinal Product Dossier (IMPD) for clinical research in the Netherlands. All essential regulatory documents have been prepared and submitted to both the Netherlands’ Competent Authority and the responsible Ethics Committee.

Clene Announces FDA Clinical Hold Placed on IND Application.

October 23, 2014 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced it had received a Full Clinical Hold in response to its IND submission on August 27, 2014. Due to the absence of identified toxicities at the highest doses tested in animals to date, the FDA has requested additional preclinical studies in animals to establish a maximum tolerated dose, maximum feasible dose, or to meet another criterion for an acceptable high dose. Clene anticipates fulfilling the FDA request by the second half of 2015.

Clene Files Investigational New Drug Application With FDA.

August 27, 2014 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced it has submitted an Investigational New Drug (IND) application with the Food and Drug Administation in the United States for its lead asset, CNM-Au8, a liquid nanosuspension consisting of clean surface elemental gold nanocrystals in buffered deionized water. The gold nanocrystal suspension is developed through a proprietary process utilizing electrochemistry and plasma physics to produce self-assembled, atomically clean-surface elemental gold nanocrystals unmodified by the addition of surfactants or surface capping agents. FDA approval of the IND will permit Clene to commence Phase I pharmacokinetic and safety studies in healthy human volunteers.

Clene Announces Incorporation.

July 31, 2014 -- Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced it had completed conversion from a Limited Liability Corporation (LLC) to a C-corp incorporated in the state of Delaware.

Pre-IND Meeting Request.

April 1, 2014 -- Clene Nanomedicine, LLC (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced it has formally requested a Pre-IND (Investigational New Drug application) meeting with the FDA to review its plan to enter clinical trials. This Pre-IND meeting is one of the final steps prior to filing an IND to begin clinical trials, and will be an opportunity to preview with the Agency its information package and clinical trial plan for Clene’s lead drug, CNM-Au8. This will clarify and allow us to resolve any remaining issues or questions. Starting clinical trials is the next key milestone in the evolution of Clene, and has important implications for the development and funding of the Company. Unlike companies in almost all other industries, most new pharmaceutical companies go public during the product development stage well before revenues, and prior to drug approval. Of the thirty-five biotech IPO’s launched through November of 2013, 85% were in clinical development stage with no commercialized drugs. In fact, the majority of 2013 biotechnology IPOs was in early to mid-stage clinical trials in Phase I or Phase II. Clene is keenly focused on completing nonclinical trials preparatory for the FDA submission package for its lead drug CNM-Au8, to propose a Phase I clinical trial, with a target of being in Phase II clinical trials closely following the completion of the Phase I program. This would continue to strengthen Clene’s pioneering nanomedicine platform technology, and could begin to position Clene as a potentially attractive IPO candidate.

Dr. William Houghton Joins Clene as Chief Medical Officer.

December 12, 2013 -- Clene Nanomedicine, LLC (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced that Dr. William Houghton has joined as the company’s Chief Medical Officer. Dr. Houghton has an exceptional track record of successful clinical development, and brings to Clene regulatory and medical expertise honed over twenty years of patient-centered clinical practice and nearly thirty years in the pharmaceutical industry. Most importantly, Bill has had exceptional success in shepherding new drug applications (NDAs) through clinical trials and working closely with the FDA to achieve approval and registration-- particularly in orphan and rare diseases, the precise area where Clene is focused. Bill’s experience in clinical development and with the FDA includes such diverse areas as narcolepsy, fibromyalgia, oncology, metabolic diseases, allogenic bone marrow suppression for adult and pediatric indications, migraine and schizophrenia therapy, utilizing oral, injection, intravenous, inhalation, and intrathecal routes of administration.
After medical school, Bill fell in love with clinical medicine and practiced for twenty years in anesthesia and intensive care. These years laid the groundwork for Bill’s career in drug development, instilling sensitivity to patients’ needs, to interpreting efficacy and safety signals, and to the practical concerns of clinicians. Bill was subsequently recruited by Abbott Laboratories to serve as medical director for Australia, New Zealand, and Southeast Asia, overseeing Medical, Scientific and Regulatory Affairs. He was ultimately promoted to international medical director at Abbott’s global center in Chicago, Illinois, where he oversaw clinical research and led international regulatory, licensing, and commercialization strategies. Bill was also medical director of Abbott’s Hospital Products Division. After eleven years at Abbott, Bill extended his experience to leadership roles in smaller pharmaceutical companies. He has been recruited to help five small companies, working primarily in orphan and rare diseases. He spent 8 years at Orphan Medical, successively as chief operating, then chief scientific and chief medical officer. At Orphan, Bill’s track record included five FDA approvals in orphan/rare indications, which he led from clinical trials to NDA registration. Bill’s clinical development work was one of the pivotal factors leading to the successful acquisition of Orphan by Jazz Pharmaceuticals. Today, one of his Orphan drugs, Xyrem (GBH), provides half the revenue of Jazz, a $6.0 B USD market-cap pharmaceutical company.
While working in orphan and rare diseases, Bill has become adept with diverse therapeutic areas, recruiting top scientific advisors and talented specialists in each. Because Clene Nanomedicine’s novel platform technology reaches so many different therapeutic areas, Bill’s diverse experience and adaptability is ideal for Clene. Regarding Clene Nanomedicine, Bill comments: “I see Clene as a unique, ground-level opportunity for a completely novel therapeutic platform--a new paradigm. It builds on and leverages all my prior experience, particularly my work with orphan and rare diseases.” Bill attended medical school at Sydney University. He and his wife Liz have dual Australian and US citizenship.