Programs

The problem

Current exogenous T treatments may carry high risk for patients:

Problem-1

Increased risk of stroke, heart
attack & high blood pressure

Problem-1

May promote
prostate tumorigenesis

Problem-1

May reduce intratesticular T
and sperm numbers
leading to infertility

ACESIS’ SOLUTION

Our T inducing proprietary family of peptides, expected upon rigorous testing and the necessary regulatory approvals, to be a safe treatment for male hypogonadism

Comparison of acesis’s novel solution with marketed low t treatments

Acesis plans to fulfill an unmet market need
ATTRIBUTE ACESIS’ PEPTIDE MARKETED T PRODUCTS MARKETED T PRODUCTS
Active compound Peptide (non-steroidal) 100% - Anabolic steroids
Intervention T Restoration (Induces the body to recover T) 100% - T Replacement (Introduces excess exogenous T)
Administration Oral >95% - Transdermal, Injections etc.
Safety No significant side effects expected & in preclinical testing our peptides are bioactive in very low concentrations 100% - Steroidal side effects FDA Black Box Warning*
Abuse/Misuse None expected 100% - Possible steroidal abuse

*”A black box warning is the FDA’s most stringent warning for drugs and medical devices on the market alerting the public and health care providers to serious side effects, such as injury or death” https://www.drugwatch.com/fda/black-box-warnings

Pipeline

Orally bioavailable ACE-167 Peptide: Platform Product Will be Developed for Additional Indications
INDICATION CONCEPT/DISCOVERY PRECLINICAL EFFICACY in relevant animal models Preclinical IND Enabling studies Phase 1 VALUE ADDED EVENT
Primary
Hypogonadism (PH)
Arrow 8 -22 months ~ 24 months
  • Peptide manufacturing
  • Pivotal animal trials
  • IND submission to FDA
Secondary
Hypogonadism (SH)
Arrow 8 -22 months ~ 24 months
  • Peptide manufacturing
  • Pivotal animal trials
  • IND submission to FDA
Orphan Diseases:
- Klinefelter Syndrome(PH)
Arrow 12 –18 months 18 – 24 months *
  • Initiate partnerships w/ academic or private partner
  • Obtain orphan drug designation
NAFLD (non-alcoholic fatty liver disease) Arrow 16 –20 months > 24 months *
  • Initiate partnerships w/ academic or industry partner
Pre-Diabetes/Diabetes type II Arrow > 18 months > 24 months *
  • Initiate partnerships w/ academic or industry partner
Overweight/Obesity Arrow > 18 months > 24 months *
  • Initiate partnerships w/ academic or industry partner
CACHEXIA
- Cancer
- HIV
Arrow > 18 months > 24 months *
  • Initiate partnerships w/ academic or industry partner

Acesis’ clinical lead ACE-167 peptide is a platform PRODUCT to be used across many disease indications where there is strong scientific evidence linking low T to conditions such as obesity and type II diabetes and as per list above; ACE-167 is targeting the same “protein to protein interaction” of 14-3-3ε with VDAC1, across all proposed indications with the biological effect to restore/increase endogenous low T levels; additional clinical studies will be required for testing the efficacy of our product candidate in the above indications.

Starting of timelines is triggered after successful closing of financing

* Additional funding will be required for testing Acesis’s drug candidate(s) in these indications

Market opportunity

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