We took an effective chemotherapy drug and made it much safer, with no side effects.

Conventional chemotherapy damages normal cells as well as cancer cells, causing toxicities that limit treatment. ONX-1006 carries paclitaxel (PTX), a widely used chemotherapy drug, chemically bound in stable nanoparticles designed to concentrate PTX in tumors while protecting normal cells.

Major Milestone: FDA IND Package and SEND Completion

On November 6, 2026, Onselex Pharmaceuticals announced completion of the FDA IND application package for ONX-1006, including the complete nonclinical summaries, Investigator's Brochure, and Phase I/IIa clinical trial protocol for Stage IV pancreatic cancer.

• 15 SEND-applicable studies converted into 199 electronic datasets, all successfully passing Pinnacle 21 validation.
• 25 complete nonclinical study reports totaling 2,122 pages, supported by more than 30 studies and over 4,000 pages of documentation.
• Complete FDA IND application documents prepared for submission.
• Only one major component remaining: The cGMP clinical manufacturing batch, which the current capital raise will fund along with the first human trial.

The IND has not yet been submitted. FDA submission will follow completion of the cGMP clinical batch.

1. Outstanding Safety Results

• Over 30 preclinical tests and 4,000 pages of supporting data.
• Excellent safety findings in rat and beagle dog GLP toxicity studies.
• Beagle dogs, weekly for 4 weeks: No Side Effects at 480 mg PTX equivalent (60 kg adult).
• Beagle dogs, weekly for 13 weeks: No Side Effects at 320 mg PTX equivalent (60 kg adult).
• 2.4× and 1.6× a typical 200 mg Abraxane (PTX) dose. Abraxane’s label reports severe side effects.

2. Superior Antitumor Efficacy

• 20% greater tumor reduction than Abraxane at the same weekly PTX dose.
• Highest tumor cell death in the test.
• Uses established chemotherapy anticancer activity.

3. Development Goals

• One year or longer of continuous treatment without side effects.
• 90–100% tumor elimination.
• 70% one-year survival rate.

These are future clinical development goals based on preclinical results.

4. Pancreatic Cancer Market Opportunity

RASONQUE – Revolution Medicines (RVMD)

• FDA Approval: Aug. 2026, Stage IV pancreatic cancer.
• One Drug, $45 Billion: Market cap, Oct. 2026.
• Survival Benefit: ~6.5 months longer.
• One-Year Survival Rate: 53.2%.
• Severe Side Effects: 43.6% (Grade ≥3).

Despite advances in pancreatic cancer treatment, severe toxicities and limited long-term survival remain major challenges. We believe ONX-1006 can address both challenges.

5. Manufacturing and Platform Expansion

• Standardized ONX-1006 manufacturing SOP.
• 15 kg of nanoparticles produced.
• Platform expansion across solid tumors and neurological diseases.

6. Our Goals

• Advance ONX-1006 into human clinical trials.
• Protect patients' quality of life.
• Extend and save millions of lives.

We invite investors and strategic partners to join Onselex in transforming cancer treatment and bringing a new generation of therapies to patients worldwide.

For investment or partnership opportunities, please visit our Investment & Partner Inquiry page and complete the inquiry form.

We look forward to welcoming you as part of Onselex’s journey.
Ernie Shin