May 2014 A bio-pharmaceutical company developing treatments for hypertension, diabetes , diabetic nephropathy and metabolic syndrome. 1
Forward-Looking Statements This document contains forward-looking information pursuant to applicable securities law. All information that addresses activities or developments that we expect to occur in the future are forward-looking statements. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans or objectives will be achieved. Actual results may differ materially from those expressed or implied by the forward-looking information set forth in this document due to risks and uncertainties affecting the Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. The forward-looking statements in this document are based on a number of assumptions which may prove to be incorrect, including assumptions concerning general business and economic conditions, positive clinical trials and the availability of financing. XORTX assumes no responsibility to update forward-looking statements in this document. 2
XORTX Company Overview • XORTX is a bio-pharmaceutical company founded on patents and patent applications that include US and worldwide rights for the development of uric acid lowering agents to treat hypertension, diabetic nephropathy, insulin resistance, metabolic syndrome and diabetes. • XORTX’s technology has been validated by successful phase II pilot trials in adolescent hypertension and chronic kidney injury. These trails demonstrated that when uric acid levels are decreased, clinically meaningful reduction in hypertension and decrease in progression of chronic kidney injury occurs. • African Queen Mines Ltd. (TSX- V: AQ) (the “Company”) is acquiring all of the issued and outstanding securities of XORTX (a private CBCA company with approximately 38 shareholders) in a reverse take-over, by way of a share exchange agreement. • XORTX will become a wholly-owned subsidiary of the Company, which will change its name to reflect its new business. • In connection with or prior to the Closing, the Company will complete a brokered private placement to raise a minimum CDN $3,000,000 and up to CDN $6,000,000 plus a 20% over-allotment option. 3
Chronically increased Serum Uric Acid is a Multi-modal cause of hypertension. Uric Acid a Novel Mechanism of Action for Hypertension 1) Uric acid- Decreases Endothelial Nitric Oxide Production VASOCONSTRICTION Nakagawa et al, Am J Physiol 2006; 290:F625-631 2) Uric acid- Increases Renin-Angiotensin-Aldosterone Activation VASOCONSTRICTION Mazzali et al Hypertension 38:1101-1106, 2001; JASN 2005; 16:35553-3562 3) Uric acid- Increases circulating Insulin concentration VASOCONSTRICTION Reaven GM, Lithell H, Landsberg L. N Engl J Med. 1996;334(6):374-381. 4) Insulin in absence during Nitric Oxide VASOCONSTRICTION SALT SENSITIVE 5) Uric Acid induces glomerular - kidney injury HYPERTENSION Mazzali et al, AJP Renal Physiol 282:F991, 2002 Conclusion: Uric acid can cause Progressive, Worsening Hypertension
Serum Uric Acid “Disease Axis” Non-Clinical Evidence Clinical Evidence Serum Uric Acid Causes Lowering Serum Uric Acid . . . “Disease Axis” Obesity BLOCKS Weight Gain Hypertension Vascular Injury Kidney Injury DECREASES High Blood Pressure Salt Sensitive Hypertension Renal Injury /Diabetic DECREASES Nephropathy Insulin Resistance Diabetes /Met Syn May Decrease Diabetes Insulin Resistance Kidney loss, Blindness, Ischemic limbs 5
The Product Vision: XORLO New Mechanism of Action : Best “first choice” for treatment of Early-Stage Hypertension A Superior Uric Acid Lowering Agent For Controlling Blood Pressure New formulation includes proprietary molecule-Oxypurinol with additives to improve bio availability. 6
A Solution with Strong Clinical Validation And Multiple Therapeutic Indications 1. New Onset Hypertension • 2 Successful Phase II Clinical Trials- Show Uric Acid is a Causative Factor. • Fieg D, et al, JAMA, 300(8):924:2008 • Soletsky B. and Fieg D., Uric Acid Reduction Rectifies Prehypertension in Obese Adolescents, Hypertension 60:1148: 2012 2. Prevention of Diabetes/Insulin Resistance 3. Prevention of Diabetic Nephropathy • 2 Successful Phase II Clinical Trials- Show Uric Acid Drives Injury • Siu YP, et al., Am J Kidney Dis, 47;1;2006 • Goicoechea, M., et al., Clin J Am Soc Nephrol, 5:1388;2010 XORLO is being developed for the indications of Hypertension and Diabetic Nephropathy. 7
Strong Correlation Between High Blood Pressure and Increased Serum Uric Acid in Adolescents 180 160 R= 0.80 Drug Intervention 140 Systolic BP LifeStyle Change 120 (mm Hg) 100 Feig D and R Johnson Hypertension 2003; 42:247- 80 252 60 1 2 3 4 5 6 7 8 9 10 Uric Acid (mg/dl) 8
Randomized Independent Phase II Trial Success in Obese, Hypertensive Adolescents Randomized trial of 60 obese, pre-hypertensive adolescents, treated for 2 months with Allopurinol to determine effect on blood pressure Oxypurinol is a metabolic derivative of Allopurinol . At 2 Months Allopurinol significantly decreased: Uric Acid: -2.4 mg/dL (p=0.0005) SBP: -11.8 mmHg (p=0.0001) DBP: - 9.6 mmHg (p=0.0002) > 80% of individuals whose uric acid was lowered blood pressure was also normalized. Weight: -3.1 kg (p=0.039) (N.B. Placebo Corrected Differences Reported) Soletsky B. and Fieg D., Uric Acid Reduction Prehypertension in Obese Adolescents, Hypertension 60:1148: 2012 9
XORTX Program Milestones (66 Months to NDA) 2015 2016 2017 2019 2014 2018 2020 $6.0 M $18 M License / Sell / Series C XORLO – Early Stage / Type I Hypertension: FDA mtg. Phase II Phase III Phase III (if necessary) NDA PhII ($31 M) ($3.6 M) ($15.2 M) Approval XORLO – Treatment of Diabetic Nephropathy Pivotal Phase III ($ XX,XXX,XXX ) Pivotal Phase III XORLO – Treatment of Diabetes/IR/ Met Syn XORTX Operations: ($1.8 M/yr) ($1.8 M/yr) ($1.2 M/yr) ($1.2 M/yr) ($1.8 M/yr) ($1.8 M/yr) ($1.8 M/yr)
Patent Portfolio Comprised of 5 Families URIC ACID LOWERING AGENTS (UALA) FDA Approvable Indications: 1- Hypertension: US 7,799,794- Claim Granted “Allopurinol for the treatment of hypertension CIP: “All UALA for Hypertension” Exp-July 2022 2- Treatment of Diabetes / Insulin Resistance: PCT-Worldwide application “Claims all UALA for the treatment of insulin resistance.” Granted in US June 2013- Worldwide pending US Exp- Sept 2028 3- Treatment of Diabetic Nephropathy: PCT-Worldwide application “Claims all UALA for the treatment of Diabetic Nephropathy” Exp-July 2028 4- Improved Dosing Formulation of Xanthine Oxidase Inhibitor: “Claims All XOI in dosing formulation for treatment of Hypertension, Insulin Resistance, Prevention of Diabetes, Prevention of Diabetic Nephropathy” PCT-Worldwide application, Exp- Mar 2033 5- Treatment of Metabolic Syndrome : US Patent Application Number 11/995,943 entitled: “Compositions and Methods for Treatment and Treatment of Hyperuricemia Related Health Consequences ” Exp-Jan 2028 11
Competitive Analysis: Hypertension Cost to Lowers Renal 1’ Side Treats Cause Patient BP Concern Effect YES XORLO (UALA) Low YES ++ None Rash ~1% SUA, RAAS, Insulin Thiazides (#1) NO Low YES Known Worsens Met Syn Contraindicated for hyperuricemia Dry Cough ~20% ACEI (#2) RAAS only Modest YES Concern Worsens Met Syn RAAS = renin-angiotensin-aldosterone system activation Conclusion • Niche 1: Only 50% of patient have adequately controlled BP, thus need for new MoA (CDC.gov) • Niche 2: Physicians first choice- Thiazides are contraindicated further support for new MoA. (~33% of prescriptions for BP) • Niche 3: Recent evidence suggests ACEI may worsen kidney function. • KEY: Treats cause & does not worsen metabolic syndrome! • Overall XORLO will be ideal first choice therapy (lower BP and prevent kidney injury)! 12
XORLO Target Markets US Market Size (individuals/year): • Adolescent Hypertension: ~2.8 million • New Onset Hypertension: ~63 million • Treatment of: • Diabetic Nephropathy: ~10 million • Diabetes/ Insulin Resistance: ~86 million • Metabolic Syndrome – Fatty Liver ~10 million 13
Strong Management Team Allen Davidoff, Ph.D., CEO and President • Former Co-Founder & CSO of Stem Cell Therapeutics • 12 Years Drug Development Experience- Bench to NDA • 8 yrs – C Level management experience-CSO, VP- Product Development • 2 IND’s – 9 Clinical trials – 1 NDA Jennifer Toddhunter, CFO • Current CFO of African Queen Mines. • Ms. Todhunter has served as VP Financial Administration, and prior to that served as the Finance Manager of both African Queen Mines and it predecessor , Pan African Mining Corp., since May 2005. • 14 yrs. experience with public companies, predominantly those in the mining industry. Irwin Olian, Chairman • Current Chairman and CEO African Queen Mines Ltd. • Founder and served as CEO and Chairman of Pan African Mining Corp. until its acquisition by Asia Thai Mining Co. Ltd. in June 2008. • Co-founder and principal shareholder of North American Scientific, Inc., a Los Angeles based manufacturer of radioisotope products for the treatment of prostate cancer. • Senior Vice President, Investments, with Sutro & Co. Inc., an established investment banking and brokerage firm in San Francisco. • He also served as Vice President of Bear Stearns & Co. Inc. 14
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