Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Moderated Conference Call: Oral Mucositis - Advancing the Next Generation of Therapies (November 2013)
22 slides from Soligenix's conference presentation, Nov 5, 2013
Slide 1: Moderated Conference Call: Oral Mucositis - Advancing the Next Generation of Therapies
(GOLIGENIX oderated Conference Call: Oral Mucositis — Advancing the Next Generation of Therapies OTC QB: SNGX
Slide 2: Conference Call Participants
Conference Call Participants Jason Kolbert Moderator and Managing Director of Biotechnology Research at the Maxim Group Stephen T. Sonis, DMD, DMSc Clinical Professor of Oral Medicine at Harvard School of Dental Medicine, Senior Surgeon and Chief, Divisions of Oral Medicine at Brigham and Women's Ho
Slide 3: Oral Mucositis
Oral Mucositis * What is Oral Mucositis (OM)? * What populations are at high risk? » What is the pharmacoeconomic impact? » What role does the innate immune system play in OM and how important is it? « What are the current therapies used to treat OM? « What other indications are related to mucositis
Slide 4: What is Oral Mucositis?
What is Oral Mucositis? * Severe, diffuse mouth sores caused by cancer treatment with chemotherapy or radiation * Affects up to 500,000 patients per year in the US * Considered by patients as the most troubling side effect of cancer treatment * Very painful with serious consequences for patient trea
Slide 5: What are the clinical features?
What are the clinical features? * Characterized by early redness of the mouth and burning » Within 10 days ulceration begins, limiting food intake and requiring narcotics + Ulceration progresses to involve large areas of the mouth making eating impossible with reliance on parenteral nutrition » Brea
Slide 6: How is severity scored?
How is severity scored? Ey J Grade 2 oral mucositis Grade 3 oral mucositis Grade 4 oral mucosit Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 None Soreness + erythema, no ulceration Ulcers. Patients can swallow solid diet Ulcers of such severity that intake limited to liquids Ulcers of such severity that
Slide 7: Who is at risk for mucositis?
Who is at risk for mucositis? * Close to 500,000 US patients per year suffer from from mucositis during cancer therapy — and the incidence is increasing Breast 14% Stem cell transplant 4% Head and Neck 15% SOLIGEN 7
Slide 8: What is the pharmacoeconomic impact?
What is the pharmacoeconomic impact? * Incremental cost of OM in head and neck cancer is ~$17,000 / patient 75,000: g © Without Mucositis/Pharyngitis 2 £23 With Mucositis/Pharyngitis % 60,000: a Ses SS 45,000. Be ws Qo 4 § B 20,000 H | Incremental cost = $17,244 s Ss 15,000- o = 6 , & LS © FS a Po x
Slide 9: What is the role of innate immunity in OM?
What is the role of innate immunity in OM? Normal Initiation Amplification Ulceration Healing Epithelium ro) 2 BI PPS Innate response to damage Epithelium Pag ALY Le f: = \) %. Y - fr bs Sub-Muscsa i emt & Wa BSS Pay @ { (GOLIGEN
Slide 10: What are the opportunities for intervention?
What are the opportunities for intervention? * The innate immune response is a key component in the initiation of the biological cascade that drives mucosal injury * It appears that the most effective interventions will be those that mitigate/prevent the activation of the initiation phase of mucosit
Slide 11: What therapies are currently used?
What therapies are currently used? Product [company | Phase [Indication [Comment issue | Kepivance Biovitrum Approved Prevent OM- Inconvenient IV dosing 3x pre + (drug) HSCT ‘3x post chemo, over priced Gelclair EKR Approved —_Palliation Poor reimbursement, poor data (device) Mucotrol Edwards Approve
Slide 12: What other indications are related to mucositis?
What other indications are related to mucositis? * The fundamental basis for all CRT-related tissue injury is similar * Consequently, an effective intervention for OM may, with modest modifications in formulation, be effective for: — Radiation-induced dermatitis — Radiation-induced proctitis — Radia
Slide 13: Why is SGX942 a good candidate in OM?
Why is SGX942 a good candidate in OM? * SGX942 is an innate defense regulator (IDR) and the first drug to address innate immunity directly to treat OM * Innate immune responses occur immediately after radiation or chemotherapy treatment and throughout the OM cycle * SGX942 therefore has the potentia
Slide 14: SGX942
SGX942 SOLIGENIX
Slide 15: Oral Mucositis
Oral Mucositis What is the mechanism of SGX942? What role does SGX942 play in oral mucositis? How might SGX942 impact oral mucositis? What is the preclinical data supporting mucositis? What is the clinical experience with SGX942? What are the next steps?
Slide 16: What is the mechanism of SGX942?
What is the mechanism of SGX942? iy aa Bacteria at x infection Damaged site Celis SGX942 Selective Effector Cell Recruitment ILira t " TNFa J Bacteria at ae ie infection site (Se Niipar q BR] Pathogen Killing & Clearance
Slide 17: What is the role of SGX942 in mucositis?
What is the role of SGX942 in mucositis? SGX942 functions immediately downstream of key innate defense receptors Responds to damage (including chemo-radiation) or pathogen associated triggers in the innate immune system Oral mucositis results from an exaggerated response of the innate immune system
Slide 18: SGX942 - Early and Continuous Impact on OM
SGX942 - Early and Continuous Impact on OM Normal Initiation Amplification Ulceration Healing Epithelium ye Innate response to damage Epithelium ~ 4 a x ay eg Stk ty! ad ba A Sub-Mucosa ¢ yi . at Jae = lL, S& ™ ie | x eS, 3) (GOLIGEN
Slide 19: Preclinical Data: Radiation-Induced Mucositis
Preclinical Data: Radiation-Induced Mucosi SclClone SCV-07 SGX942 p= 027 46% reduction} = 006 33% reduction X ‘%Animal Days with a Score of >/= 3 Summary: SGX942 (25mg/kg, IV) dosed every third day (| group) or on days of radiation treatment (green group) A dosing regimen which is most similar to th
Slide 20: Preclinical Data: Chemotherapy-Induced Mucositis
Preclinical Data:Chemotherapy-Induced Mucositis _ Duration of Severe Endoscopy % Body Weight each Day 3 Mucositis (Colitis) Score 5 Vehicle Days 1,2, 5 =e SGx94 Day i,2,5 53% reduction P<0.001 <05 Mean Endoscopy Colitis Score (+/-SEM) Mean % Weight Change (+/-SEM) % Animal Days with a Score of 3 o V
Slide 21: Clinical Experience - Completed Phase 1 Study
Clinical Experience — Completed Phase 1 Study » Placebo-controlled, randomized trial in 84 normal, healthy subjects + Single ascending dose phase of 54 subjects in 6 cohorts at doses up to 8 mg/kg + Multiple ascending dose phase of 30 patients in 5 cohorts at doses up to 6.5 mg/kg/day for 7 days * N
Slide 22: Next Steps - Phase 2 OM Clinical Study
Next Steps — Phase 2 OM Clinical Study * Double-blind, randomized, placebo-controlled trial with ~75 patients at ~25 centers * Initiation: H2 2013; Primary endpoint data: H2 2014 * Patients with tumors of the oropharynx and oral cavity undergoing intensity modulated radiation (IMRT) of 2.0-2.2 Gy pe