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Compounds For Cures. To the extent that statements in this presentation are not strictly historical, including statements as to revenue projections, business.

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Presentation on theme: "Compounds For Cures. To the extent that statements in this presentation are not strictly historical, including statements as to revenue projections, business."— Presentation transcript:

1 Compounds For Cures

2 To the extent that statements in this presentation are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this presentation are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix's success are more fully disclosed in Cellceutix's most recent public filings with the U.S. Securities and Exchange Commission. Safe Harbor Forward-Looking Statements

3 Management Leo Ehrlich, CPA CEO and Chief Financial Officer Board of Directors Founder of Cellceutix in 2007 CEO since December 2010

4 Management Krishna Menon, RCM, PhD, VMD President, Chief Scientific Officer Board of Directors Dr. Menon has more than 30 years in drug development for academia and industry Menon's PhD work focused on anti-folate therapy of various cancers. Menon was a Research Associate Scientist at Dana Farber (Harvard University) from 1988 to 1991 and Research Scientist, In Vivo Research (Cancer & Metabolic Diseases), at Miles Laboratories from 1991 to 1993 Group Leader, Cancer In Vivo Research and Clinical Development, for Eli Lilly (1995- 2001), where he played a key role in lead selection and pre-clinical development of Gemzar and Alimta, well known multi-billion dollar drugs In 1999, Lilly honored Menon with the President's Recognition Award, the most prestigious award at Lilly

5 Key Acquisition Acquired PolyMedix September 4, 2013 Pipeline consists of 10 compounds for infectious diseases, cancer supportive care and antimicrobial applications Proprietary computational drug design technology Substantial equipment assets Brilacidin completed Phase IIa clinical trial Delparantag - Good Efficacy but with SAE- Possible reformulation 2012 - $227 million market cap (before bankruptcy) - Outperform rating - strong institutional support Brilacidin Small molecule, first-in-class defensin-mimetic antibiotic Completed 200-patient Phase II clinical trial in patients with ABSSSI caused by Staph aureus Hit primary endpoints, high and low doses outperformed Cubist Pharmaceuticals Cubicin in control arm Prime candidate to benefit from GAIN Act of 2012 Other possible indications include blood stream infections, lung infections and oral mucositis Delparantag Anticoagulant reversing agent Multiple clinical trials showed drug to reverse heparin and low molecular weight heparin We are in the excellent position to be Monday Morning Quarterbacking Adverse side effects; re-formulation possible

6 Active Projects Kevetrin Breakthrough p53 targeted activator Drug resistant cancers, e.g., lung, breast, colon Phase 1 at Dana Farber/ Harvard Cancer Center and Beth Israel Deaconess Medical Center (BIDMC) began Nov 2012 Phase1b trial at University of Bologna for hematological cancers Additional Phase 2 trial at BIDMC for renal cell carcinoma Prurisol (KM-133) Psoriasis FDA 505(b)(2) application to be filed Drug manufacturing completed by Dr. Reddys Labs (SYMBOL:RDY) KM-391 Autism

7 Kevetrin for Cancer Unique chemistry Strong IP position; many novel compounds in patent application Unique mechanism of action Wild type and mutant p53 (p53 is a potent tumor suppressor) Transcriptional dependent and independent manner p53 is a potent tumor suppressor Large therapeutic index Potent anti-tumor activity even in drug resistant tumors Excellent toxicity profile No development of drug resistance Non-genotoxic

8 Kevetrin Phase 1 Dana Farber / Harvard Cancer Center and Beth Israel Deaconess Medical Center (BIDMC) Dose escalation study in chemotherapy-resistant subjects with solid tumors Cycle: treatment once/ week for 3 weeks, followed by 1 week off treatment p53 status of tumors will be evaluated 18 patients enrolled to date Endpoints Safety Maximum Tolerated Dose (MTD) Tumor size Serum tumor markers Biomarker: increased p21 expression in lymphocytes Completed 4 cohorts, currently in 5 th cohort 1 subject completed 7 cycles, 1 completed 4 cycles No dose limiting toxicity Have not yet reached maximum tolerated dose 5 th cohort dose is 7.5 times initial dose; 75mg/m 2

9 Kevetrin Phase 1 Observed stabilization of disease by restaging in multiple types of cancer Evidence of stable disease by radiological examination in 6 cases, which includes head and neck cancer, ovarian cancer, liposarcoma and clear cell carcinoma Disease progression occurred following stabilization of disease in some cases Subject 103 had 6 months of treatment and 2 successful restaging with stable disease Subject 202 completed 4 cycles of treatment *Stabilization was achieved at low doses in terminal patients with relapsed tumors that were resistant to current chemotherapies. Pharmacokinetic profiles and parameters show no evidence of accumulation in plasma This points to possibility to increase dose and frequency p21 biomarker expression in patients Kevetrin activated p21 in 4 out of 5 patients treated with 20 or 30 mg/m 2

10 Kevetrin Phase 1 No alteration in hematological profile was observed due to Kevetrin No leukopenia No neutropenia No anemia No thrombocytopenia *In contrast, standard cytotoxic chemotherapeutic drugs have adverse effects on hematology During infusion with Kevetrin: No neuropharmacological changes were observed No adverse effects on cardiovascular system No change in subjects cardiac rhythm or ECG No change in respiratory rate, minute volume or tidal volume

11 Kevetrin Phase 1 Adverse Events No observed Serious Adverse Events (Grade 3) attributable to Kevetrin to date (5 th cohort at 75 mg/m 2 ) Observed Adverse Events (Grade 1, Grade 2): Cutaneous erythema (redness of the skin) was observed in a few subjects, lesser number had pruritus Reactions subsided when infusion was completed Reactions were manageable with antihistamines and steroids Occurred without hemodynamic changes

12 Kevetrin Phase 1 Adverse Events The following occurred in at least 1 subject: Nausea Vomiting Chest tightness Shortness of breath High blood pressure Fatigue Pre-medication with antihistamines or steroids was administered per direction of the attending physician *None were Grade 3 Adverse Events

13 Active Projects Kevetrin Breakthrough p53 targeted activator Drug resistant cancers, e.g., lung, breast, colon Phase 1 at Dana Farber/ Harvard Cancer Center and Beth Israel Deaconess Medical Center (BIDMC) began Nov 2012 Phase1b trial at University of Bologna for hematological cancers to start 2014 Additional Phase 2 trial at BIDMC for renal cell carcinoma to start 2014 Prurisol (KM-133) Psoriasis FDA 505(b)(2) application KM-391 Autism

14 Prurisol for Psoriasis Prurisol Controls

15 Prurisol for Psoriasis Drug product: Manufacturing has been completed by Dr. Reddys Laboratories, Ltd. (NYSE: RDY) Tablet is ~250 mg

16 Pipeline IndicationCompound CancerKevetrin (KM-3174) PsoriasisPrurisol (KM-133) AutismKM-391 ABSSSI, Blood Stream Infections, Lung Infections Brilacidin Anticoagulation ReversalDelparantag Oral MucositisBrilacidin-OM NeurologicalKM-362 ArthritisKM-277 Arthritis/AsthmaKM-278

17 Pipeline (cont.) IndicationCompound Hypertensive EmergencyKM-732 Biomaterials ApplicationsPolyCide Bacterial InfectionsPMX-50003 Bacterial InfectionsPMX-70004 TuberculosisPMX-10072 MalariaPMX-30024 Fungal InfectionsPMX-10098 BiodefensePMX-30016 OncologyPMX-20005

18 www.Cellceutix.com Thank You!


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