Unlocking Immunology for a Better Tomorrow
Corporate Presentation
June 2024
Forward Looking Statements
This presentation contains certain statements which are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward- looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2023 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.
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Tharimmune (Nasdaq: THAR) Company Highlights
TH104: De-risked Clinical Program with approved active + novel delivery
Recently completed Phase 1 study. Positive safety readout and topline full readout completed 1H24
Anticipate initiation of Phase 2 in 2024 with potential Registrational Trial ready in 2025
Currently Funded into 2025
Company completed transaction for $11M public offering in 4Q23
Estimated Large Annual Market Opportunity for Pruritis Expansion
Initial indication: moderate-to-severe chronic pruritus in primary biliary cholangitis
Indication expansion to Pruritogenic Diseases, including atopic dermatitis (>$15 Billion market)
Expanded Pipeline and Platform Technologies
Bispecific ADC to target novel conformational epitopes on high value validated targets: HER2/HER3
Knob Domains- smallest known antibody fragments targeting undruggable epitopes
IP Protection of Assets
Multiple US Patents with wholly-owned Global commercial rights to pipeline
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Pipeline and Anticipated Milestones
Stage | Candidate | Modality & Indication | Preclinical | Phase 1 | Phase 2 | Anticipated |
Milestones | ||||||
Transmucosal Film : | 2024: | |||
avoids first pass liver effect | 2Q: Ph1 Readout | |||
Moderate-to-Severe | Phase 2 Ready* | Ph2 Initiation | ||
TH104 | ||||
Clinical | Chronic Pruritis in Primary | 2025: | ||
Stage | MOR/KOR | Biliary Cholangitis | Ph2 Topline | |
(+ ↓IL-17) | ||||
Readout | ||||
Undisclosed | Phase 1 Ready* | Potential | ||
Registration Trial | ||||
Indication | ||||
Initiation | ||||
PD-1/HER2/HER3 | 2024: | |||
Early | Bispecific Antibodies/ADCs | Pre-clinical Studies | ||
Stage | Multi-specific Knob | for multiple solid tumors | 2025: | |
Domain Platform | IND enabling studies | |||
*Pending discussions with FDA
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Lead Asset:
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Chronic Pruritis Highly Prevalent in Liver Disease Patients
Primary Biliary
Cholangitis
Affects 1 in 1,000
women over 40
< 200k US patients1
(similar in EU4+UK)
>70%
of PBC patients affected by pruritus at some point during their disease course2
Prevalence of pruritus in liver diseases2,3,4
PBC | Overlap Syndrome | Chronic HCV |
75 % 60 % 45 %
MASLD | PSC | Total |
45 % 70 % 40 %
1. Lu, M et. al. Clin Gastro Hepatol 2018 Aug;16(8):1333-1341.e6. doi: 10.1016/j.cgh.2017.10.018)
- Gungabissoon U, et al. BMJ Open Gastro 2022;9:e000857. doi:10.1136/bmjgast-2021-000857
- Oeda, S, et al. Prevalence of pruritus in patients with chronic liver disease: A multicenter study, Hepatology Research, 48: E252-E262, (2018)
- Nietsche Cholestatic pruritus: a knowledge update, Anais Brasileiros de Dermatologia,Volume 97, Issue 3, 2022.
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Nalmefene: Established Proof-of-Concept with Limitations
Nalmefene is currently only approved in US as intravenous and intranasal routes for acute use: opioid overdose*
Not ideal for chronic use
Oral route (approved in Europe) explored with high doses potentially due to first pass liver metabolism1;
Efficacy established in PBC patients with pruritis, but avoidance of liver metabolism could be beneficial in liver impaired patients.
Nalmefene Suppresses Pruritus in PBC Patients1
Oral dose ranging from 40 to 240 mg BID x 12 weeks
Nalmefene therapy was associated with a 75% reduction in hourly
scratching activity (P< .01)
1. Bergasa N et. al. Oral nalmefene therapy reduces scratching activity due to the pruritis of cholestasis: a controlled study J Am Acad Dermatol 1999;41:431-4 *Tablet formulation approved in Europe for Alcohol Use Disorder
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TH104: Proprietary Biodegradable Transmucosal Buccal Film
The Phase 1 study demonstrated TH104 oral film had comparable safety and tolerability to IV
Adheres to inner-cheek
Drug film is dime-sized
Active drug (nalmefene): transmucosal
TH104: Nalmefene transmucosal film
- Validated mechanism: MOR/KOR activation (+ IL-17 inhibition)
- De-riskedCMC using proprietary transmucosal film technology
- Two issued patents with multiple patents pending
TH104
developed by
embedding drug onto proprietary transmucosal film
TH104 designed
to bypass the
liver
(no first pass
effect)
- Once-DailyDosing
- Rapid Onset
- High Absorption
- Absorbed in oral mucosa & distributes to skin
- Designed to treat liver impaired conditions
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Initial Indication: Moderate-to-Severe Chronic Pruritis (itching) in PBC
In patient testimonials, PBC itch is described as "the worst, most unimaginable itch", like bugs crawling under the skin".
- PBC is an orphan disease in the USA and Europe, with <200k patients in the US.
- Affects men & women (rate higher in women: ~ 1 in 1,000 > 40 years old)2
- 65% of patients have "worse nocturnal pruritus" with 71% of patients stating a disturbance in their sleep3
More than 70% of Primary Biliary Cholangitis (PBC) patients affected by pruritus1
PBC is a chronic disease where bile ducts in the liver are eventually dysfunctional; the bile builds up and causes liver damage.4
- Gungabissoon U, et al. BMJ Open Gastro 2022;9:e000857. doi:10.1136/bmjgast-2021-000857
- https://www.healthywomen.org/condition/primary-biliary-cholangitis-pbc
- Rishe et. al. Itch in Primary Biliary Cholangitis: A Patients' Perspective Acta Derm Venereol 2008; 88: 34-37
- https://www.niddk.nih.gov/health-information/liver-disease/primary-biliary-cholangitis/definition-facts
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TH104 Mechanism of Action: Modulation of MOR/KOR
Pruritic Skin | Normal Skin |
Induction of itch from overactivation of | THAR104 looks to balance MOR and |
MOR and/or KOR deactivation | KOR activation to relieve pruritis |
Kappa-opioid receptors (KORs) and mu-opioid receptors (MORs) have been implicated in both the suppression and promotion of itch, respectively, and pronounced in conditions such as liver and atopic diseases
Endogenous Opioids
Overexpressed in CLD2
β-endorphin/dynorphin A ratio
VAS pruritus score in patients with CLD
CLD - chronic liver disease
- Kim, BS, et. al. Role of kappa-opioid and mu-opioid receptors in pruritus: peripheral and central itch circuits. Exp Dermatol. 2022; 31: 1900-1907. doi: 10.1111/exd.14669
- Moniaga CS, et. al. Plasma dynorphin A concentration reflects the degree of pruritus in CLD Acta Derm Venereol. 2019 Apr 1;99(4):442-443. doi: 10.2340/00015555-3139.
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Tharimmune Inc. published this content on 08 July 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 July 2024 14:40:07 UTC.