VOLT01 Reformulated Zoledronic Acid Targeted to be the first Disease- Modifying Drug in Osteoarthritis

 Levolta reformulates approved products to enhance their customer value, such as efficacy, safety and convenience.  VOLT01, a reformulated zoledronic acid, has demonstrated superior efficacy and safety in patients with knee osteoarthritis vs Novartis’ Reclast®  VOLT01 has advanced to phase III in Australia and is targeting a global placebo-controlled phase III trial in 1H  VOLT01 has broad patent protection in the U.S. and in International markets.

Levolta is currently focused on the development of its lead product, VOLT01, which will be the first approved therapy that treats osteoarthritis disease. += VOLT01

Cohort Post-dose Syndrome (Main Side effect) Change in Bone Marrow Density Change in Mean Visual Analogue Score (pain measurement) Reclast®9/16 (56%)0-10 mm VOLT012/16 (13%)0-35 mm EFFICACY: VOLT01 was statistically significantly superior to ZA (measured by VAS) with p<0.05*. SAFETY: VOLT01 was superior to ZA in safety (measured by PDS). SUSTAINED EFFECT: Patients in these cohorts were followed for 6 months with a significant reduction in pain still being reported. DISEASE MODIFICATION: The sustained effect suggests that disease is being modified, as was also suggested by the ZAP** study. ACR Poster Presentation Statistical analysis was done by an independent contractor (Percept Pharma Services, NJ). A phase 2 randomized controlled trial of ZA in OA of knee in Australia (ZAP study, Zoledronic Acid for Knee Pain) showed efficacy at six months of ZA in decreasing bone marrow lesions in OA by MRI.

Knee OA $2.7B The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.2% between 2010 and 2018 to $38 billion.

VOLT01 (zoledronic acid) There are no approved therapies that treat osteoarthritis disease, only the associated signs and symptoms. VOLT01 is the only DMAOD currently in development. Indirect competition may exist from pain and anti-inflammatory mediations, as well as surgeons with practice economic concerns.

7 Begin Global Phase III trial of VOLT Phase III trial in Australia (cost effective trial with Menzies Group provides differentiation vs Reclast. Results will drive global reimbursement). 2 Enter Phase III trial in Russia (will serve as a supportive trial for FDA / EMA approval. Independent regulatory body and cost efficiencies make Russia an attractive space). Leverage interim analysis data from AU into FDA / EMA meeting 3 3 File New Drug Application (NDA) with Therapeutic Goods Administration in Australia 4 4 File NDA with FDA, EMA & Ministry of Health (RUS) 5 5 Approvals in AU, NZ & some Asia Pacific countries 6 6 Approvals in USA & Russia Approvals in Europe & rest of world

First line in treatment of osteoarthritis Pharmacoeconomic benefit Enhanced Patient Compliance Superior safety profile

United States Patent # 8,859,530 issued on 10/14/14 Claims methods for treating OA by intravenously administering a combination of Zoledronic acid and steroids in a single infusion. Covers a method for providing long-term relief to OA. United States Patent # 9,012,432 issued on 04/21/15 Much broader claims …. Treatment of osteoarthritis with ZA and any steroid (not just prednisolone), but to any mode of administration (not just IV), and not just a single infusion. The application also includes various composition claims. 03/11/15 - Patent Cooperation Treaty Application No: PCT/US14/22169 International Preliminary Examination Report (“IPRP”) concluded that all of the pending claims have been indicated as being novel, inventive, and having industrial applicability.

Levolta is seeking a partner for development, sales and registration. Levolta is interested in global, regional and local partnering opportunities. VOLT01 is projected to be commercialized in 3 years.

After reviewing this Presentation Deck please feel free to contact Mr. Richard Becker with any questions you may have. Richard Becker, CEO Levolta Pharmaceuticals