LadRx Corporation · OTC:LADX
LadRx — Investor Presentation (March 2025)
20 slides from LadRx's investor presentation, March 2025
Slide 1: Corporate Overview March 2025
OTCQB:LADX CORPORATE OVERVIEW March 2025 Non-Confidential
Slide 2: LadRx Corporation Safe Harbor Statement
LadRx Corporation Safe Harbor Statement THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE CERTAIN RISKS AND UNCERTAINTIES. SUCH STATEMENTS MAY BE PRECEDED BY THE WORDS “INTENDS,” “MAY,” “WILL,” “PLANS,” “EXPECTS,” “ANTICIPATES,” “PROJECTS,” “PREDICTS,” ESTIMATES,” “AIMS,” “BELIEVES,
Slide 3: Management and Board
Management and Board Board of Directors • Jennifer Simpson, PhD LadRx Chair of the Board. CEO of Panbela Therapeutics. Former CEO of Delcath, Oncology Stephen Snowdy, PhD Gilad Gordon, MD John Caloz Lead at Imclone, Product Director Oncology CEO R&D/Regulatory Consultant CFO Marketing at Ortho Biote
Slide 4: Despite Progress, Cancer is a Massive Burden Needing Solutions
Despite Progress, Cancer is a Massive Burden Needing Solutions In 2019, cancer claimed over 10 million lives worldwide 1 Leading attributable causes (approx. half of cancers are attributable) are smoking, alcohol use, and high BMI 1 Cancer is the second leading cause of death in the US, behind heart
Slide 5: Investment Highlights
Investment Highlights LadRx has developed elegant tumor targeting and release molecules called LADR that are based on small molecular entities (no complex antibodies or nanoparticles) allowing for higher dosing, lower off-target toxicity. With LADR, no need to screen patients for targets. ➢ First LA
Slide 6: LADR=Linker-Activated Drug Release
LADR=Linker-Activated Drug Release LADR-based drugs take advantage of circulating albumin as trojan horse: ➢ Most abundant protein in blood ➢ Major source of amino acids for tumors* ➢ Tumors use as carrier for metabolites, hormones, nutrients* ➢ Undergoes macropinocytosis* ➢ Accumulates in tumors du
Slide 7: Aldoxorubicin: 1st Gen LADR-Based Drug Has Proven Higher Dosing with Improved Safety
Aldoxorubicin: 1st Gen LADR-Based Drug Has Proven Higher Dosing with Improved Safety in Human Trials Compared to Native Doxorubicin ➢ LADR allows for 3X higher dosing or more of doxorubicin When attached to LADR backbone, ➢ Aldoxorubicin crosses the Blood-Brain doxorubicin has Barrier been dosed in
Slide 8: Aldoxorubicin-Early Clinical Experience
Aldoxorubicin-Early Clinical Experience Phase I • Inclusion of up to 700 mg/m2 prior doxorubicin or epirubicin • No tox up to 200 mg/m2 dose equivalence (DE) • 260 mg/m2 Grade 2 mucositis, anemia, grade 3 neutropenia/leukocytopenia • 340 mg/m2 DE determined to be MTD • RP2D: 260 mg/m2 DE every 3 wee
Slide 9: Aldoxorubicin-Phase II in Soft Tissue Sarcoma
Aldoxorubicin-Phase II in Soft Tissue Sarcoma Structure • Advanced Soft Tissue Sarcoma versus doxorubicin, randomized 2:1 • Pts could have received up to 225 mg/m2 DE of doxorubicin adjuvant, but were naïve for advanced STS systemic therapy • 21-day cycle for 6-8 cycles • Aldoxorubicin 260 mg/m2 DE
Slide 10: Aldoxorubicin-Phase III in Soft Tissue Sarcoma
Aldoxorubicin-Phase III in Soft Tissue Sarcoma Structure • Structure very different from successful Phase II • 433 patients, randomized 1:1 to aldoxorubicin at 260 mg/m 2 DE on 21-day cycle versus investigators choice among 3 regimens that included, 1) dacarbazine, pazopanib, gemcitabine/docetaxel;
Slide 11: Plan for Aldoxorubicin: NDA under 505(b)(2)
Plan for Aldoxorubicin: NDA under 505(b)(2) • Doxorubicin sells approximately $1B per year, and is dose limited by cardiotoxicity • Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act allows for marketing approval of drugs that employ an active ingredient of an already approved drug (the “
Slide 12: Next-Gen LADRs: LADR 7, 8, 9, 10
Next-Gen LADRs : LADR 7, 8, 9, 10 • High-throughput screening yielded four compounds selected for evaluation: • LADR 7: Auristatin-E with Ketone Linker • LADR 8: Auristatin-E with Ester Linker • LADR 9: Maytansine with Ketone Linker • LADR 10: Maytansine with Ester Linker • Auristatins and Maytansin
Slide 13: LADRs 7 and 8 in PDX/CDX cancer models: Melanoma
LADRs 7 and 8 are powerful anti-cancer drugs in multiple PDX/CDX cancer models: Melanoma
Slide 14: LADRs 7 and 8 in PDX/CDX cancer models: Ovarian
LADRs 7 and 8 are powerful anti-cancer drugs in multiple PDX/CDX cancer models: Ovarian
Slide 15: LADRs 7 and 8 in PDX/CDX cancer models: Non-Small Cell Lung Cancer
LADRs 7 and 8 are powerful anti-cancer drugs in multiple PDX/CDX cancer models: Non-Small Cell Lung Cancer
Slide 16: ...As are LADRs 9 and 10
.As are LADRs 9 and 10 w of the antitumor activity of maytansine and bumin-binding drugs in various human PDX and nograft tumor me glee rel els e. IEA bos 4 ABB 1 of b ils Flee z 3k & glelle/s lode ge glg/22 be eee 8 tle] eg mad a vPP EEE oem ARIE 25 & sls|s.3 cae [Ts 3 ame |e ora [ans | , ene ee oy
Slide 17: All Four LADR Candidates Meet Initial Development Criteria
All Four LADR Candidates Meet Initial Development Criteria Maytansinoid LADR s (LADR- Auristatin LADR s 9 and (LADR-7 and LADR-8) LADR-10) Selective Binding to Albumin and Stable in Plasma Payload Releases at pH 4 Robust Anti-Tumor Activity in Multiple Tumor Types Durable Responses Averaged 60‒90 Da
Slide 18: Next-gen LADR Drug, LADR-7, Near IND Readiness
Next-gen LADR Drug, LADR-7, Near IND Readiness ✓ Stability in plasma (mouse, rat, dog, monkey, human) ✓ pH-dependent release ✓ Rat and mouse MTD ✓ In-vitro efficacy ✓ In-vivo efficacy (small and large tumor PDX and CDX) ✓ Non-GLP rodent tox ✓ CMC ✓ Manufacturing of clinical batch under Good Manufact
Slide 19: Business Status of Arimoclomol and Aldoxorubicin
Business Status of Arimoclomol and Aldoxorubicin Xoma, Inc. In 2023, LadRx transferred the economic rights to aldoxorubicin and arimoclomol in exchange for certain payments from Xoma to LadRx: ✓ $5M gross proceeds upon closing ✓ $1M upon acceptance by FDA of arimoclomol NDA ✓ $1M upon first commerci
Slide 20: Summary
Summary LadRx has developed a targeted delivery platform for chemotherapeutic agents that takes advantage of the concentration of albumin in solid tumors. Being small molecules, the agents are easier/cheaper to manufacture than macromolecules, confer solubility, cross the blood-brain barrier, and ar