Moonlight Therapeutics is a clinical-stage biotech company developing MOON101, a novel microneedle stamp treatment for peanut allergy that delivers allergen proteins directly into the skin to safely desensitize the immune system.
The Problem
30 million Americans suffer from food allergies, with 6 million affected by peanut allergy—a life-threatening condition with no robust, disease-modifying treatments widely adopted.
Current management relies on strict avoidance and emergency epinephrine, leaving patients and families in constant fear of accidental exposure.
The Solution
Moonlight Therapeutics’ proprietary microneedle stamp technology delivers food allergens directly into the upper skin layers, targeting skin-resident immune cells for efficient desensitization while minimizing systemic exposure.
This quick (<5-minute) application enables a robust efficacy response with a reduced risk of systemic reactions compared to oral therapies.
Lead Product
MOON101—the company’s first candidate for peanut allergy—has demonstrated strong efficacy in animal models, with results published in peer-reviewed journals.
Leadership
- Samir Patel, PhD – CEO & Co-Founder
Previously co-founded Clearside Biomedical (NASDAQ: CLSD), where he invented the suprachoroidal injection technology that led to FDA-approved XIPERE® and a successful 2016 IPO. Holds a BS in Chemical and Materials Engineering from UC Berkeley and a PhD from Georgia Tech. - Vladimir Zarnitsyn, PhD – COO & Co-Founder
Biomedical engineering expert with deep experience in medical device development, intellectual property, and regulatory strategy. Co-founded Clearside Biomedical and developed the device component of its FDA-approved therapy. Author of 20+ peer-reviewed publications, 27 patent applications, and 6 issued patents.
Commercial Strategy
- Target Prescribers
Upon FDA approval, MOON101 will be prescribed by allergists. - Reimbursement
Focus on securing insurance coverage and formulary inclusion for broad patient access. - Commercialization Approach
Intention is to partner with an established player experienced in selling to allergists rather than building an internal sales force. - Exit Pathways
Primary: IPO or acquisition following positive Phase 2 efficacy data.
Backup: Strategic partnership for co-development, with partner funding later-stage trials in exchange for commercial rights.
Post-approval revenue will come from product sales to allergists, supported by insurance reimbursement and formulary placement.
Moonlight intends to partner with a commercial-stage organization for distribution and sales, enabling efficient market penetration without building a full internal infrastructure.
Investment Ask
Moonlight Therapeutics is raising $2.5 million to fund efficacy data collection in peanut-allergic children within its ongoing, already-funded safety trial.
- Structure
SAFE or priced Series A-2 round - Existing Commitments
$1 million already secured - Use of Proceeds
Complete the current trial and generate pediatric efficacy data - Timeline
Trial completion within 2 years; target close of round in Q3 2026
This capital will bridge the company to a major value-inflection point with clinical efficacy results, positioning Moonlight for larger follow-on financing, partnership, or exit.
Current Status & Milestones
- Clinical Stage
Entering clinic in January 2026 with IND cleared by FDA (2025) - Regulatory Path
Drug/device combination product regulated by CBER; targeting Biologics License Application (BLA) - Trial Readiness
Protocol finalized and IRB-approved; 5 clinical sites selected (3 in Southeast); first GMP clinical batch manufactured - Next Milestone
First patient dosing expected January 2026
All preclinical animal studies were completed with published data supporting the safety and efficacy of the microneedle delivery platform.
Moonlight Therapeutics has secured $15.2 million in non-dilutive and private funding to date.
| Source | Amount | Year(s) |
|---|---|---|
| NIH SBIR Grants (3 awards) | $9 million total | 2019, 2023, 2024 |
| DOD CDMRP Grant | $3.3 million | 2025 |
| Private Seed Round | $2.9 million | 2024–2025 |
