Total US AD patients
Atopic dermatitis prevalence — 10% of US population
Investor Presentation · 2026
A new class of antimicrobial.
Niche Biopharmaceuticals is developing NB2 — a topical small-molecule new chemical entity with coupled anti-infective and immunomodulatory action. Resistance-resilient. Pre-IND complete. Two lead indications: atopic dermatitis and diabetic foot ulcers.
52wk
No resistance development at sub-MBC
40+
Bacterial organisms with µg/mL activity
2
Lead indications: AD + DFU
3
Issued US composition & use patents
What we do
Two problems. One molecule.
NB2 — a Coupled Anti-Infective Immunomodulatory Therapeutic — pairs direct antimicrobial action with built-in anti-inflammatory effect in a single new chemical entity.
Broad-spectrum potency
µg/mL activity against more than forty bacterial organisms — including AD-driving S. aureus and DFU-implicated strains — plus enveloped viruses such as SARS-CoV-2 and influenza.
Resistance-resilient
52 weeks of continuous passage at 50% of the MBC against S. aureus MN8 produced no observed resistance development — a property of the chemical class.
Dual mechanism by design
Anti-infective and immunomodulatory action coupled in the same molecule — not delivered as a combination. Toxin synthesis shut down at 1/15 of MBC.
Where we are
From bench to first-in-human.
A pre-IND meeting was completed with FDA Dermatology in May 2024 on the lead atopic dermatitis program. A parallel DFU pre-IND meeting is planned post-financing close.
Our Science
The CAIT class & NB2.
CAIT — Coupled Anti-Infective Immunomodulatory Therapeutic — is a proprietary chemical class invented at Niche. NB2 is a lipase-resistant analogue of glycerol monolaurate (GML), the antimicrobial scaffold in human breast milk.
The Compound
NB2 — a new chemical entity.
NB2 is classified as a new chemical entity per FDA regulations, qualifying for 5-year NCE exclusivity at approval. It is structurally optimized from glycerol monolaurate (GML) — the antimicrobial scaffold in human breast milk — to be fully lipase-resistant.
Class
CAIT — Coupled Anti-Infective Immunomodulatory TherapeuticProprietary chemical class invented at Niche.
Lead
NB2 — New Chemical EntityFirst synthesized at Niche to >99% purity.
Activity
µg/mL range, > 40 organismsPlus enveloped viruses such as SARS-CoV-2 and influenza.
Resistance
None observed at 52 weeks, 50% MBCContinuous-passage culture against S. aureus MN8.
Mechanism
Coupled anti-infective + anti-inflammatoryIn one molecule — not a combination product.
Mechanism
Two problems, one molecule.
01
Direct antimicrobial activity
µg/mL bactericidal potency against more than 40 bacterial organisms. Activity extends to enveloped viruses including SARS-CoV-2 and influenza.
02
Coupled anti-inflammatory effect
Toxin production (TSST-1 and other superantigens) is shut down at sub-MBC levels — addressing the inflammatory driver of disease in tandem with infection. Built into the same molecule, not delivered as a combination.
03
Resistance-resilient by design
Lipase resistance combined with multi-target action limits bacterial escape pathways. The 52-week no-resistance result is a property of the chemical class, applicable across S. aureus-driven indications.
The Headline Result
52 weeks. No resistance.
Antimicrobial resistance is the dominant failure mode in anti-infective drug development. NB2's chemical class did not select for resistance under continuous selective pressure — a foundational property that motivates both lead indications.
Fig. 02 — Continuous-passage assay, illustrative
MBC trajectory: NB2 vs. comparator class
Compounds in the CAIT class were cultured continuously at 50% of the minimum bactericidal concentration — a pressure regime designed to select for resistant survivors. Over 52 weeks the bacteria did not develop resistance.
This is not a single-organism result; it is a property of the chemical class. MRSA panel expansion is planned in Year 1 to confirm class-level validation across clinical isolates.
A resistance-resilient antimicrobial that also resolves inflammation — in one molecule — is what the field has wanted for a generation.
Preclinical Data
5–10× more potent. Full lipase resistance. Tox clean.
In vitro · S. aureus MN8
Potency vs. GML reference
| Compound | MIC (µg/mL) | MBC (µg/mL) | Toxin inh. |
|---|---|---|---|
| GML | 300 | 300 | 16 |
| NB2 | 31 | 63 | <4 |
Toxin synthesis shut down at 1/15 of MBC — anti-virulence at sub-killing dose.
In vivo & tox
10⁹-fold S. aureus reduction.
In the validated rabbit AD model, NB2 produced a 10⁵-fold S. aureus reduction at 4 hours and a 10⁹-fold reduction at 8 hours, with clear time- and dose-dependent response across 15 and 30 mg/mL doses.
The minipig dermal tox study (completed February 2025) established NOAEL at 25 mg/kg BID over 7 days at 10% BSA, with plasma exposure of 2–6 ng/mL and no accumulation. Top proposed clinical dose: 15 mg/mL — well below NOAEL margin.
25
NOAEL (mg/kg)
2–6
Plasma (ng/mL)
15
Top dose (mg/mL)
Pipeline
Two lead indications. One mechanism. Platform breadth behind it.
NB2 targets S. aureus and its inflammatory drivers across two large, underserved markets — with extensible application across 10+ rare dermatology indications and the type 2 diabetes superantigen pathway.
Program
Indication
Modality
Stage
Next milestone
NB2-ADLead program · pre-IND complete
Atopic dermatitis
Topical small molecule
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
IND filing → Phase 1A
NB2-DFULead program · preclinical
Diabetic foot ulcer
Topical small molecule
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
FDA Type B pre-IND meeting
CAIT platform10+ rare derm + T2D mechanism
Multi-indication
Topical small molecule
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
Indication prioritization
Platform breadth — additional indications under evaluation
Bullous pemphigoid
Pemphigoid
Job Syndrome
Psoriasis
Ichthyosis
Desquamative inflammatory vaginitis
Localized scleroderma
Dermatitis herpetiformis
Chronic lupus with skin involvement
Cutaneous T-cell lymphoma
Sjögren's syndrome
Type 2 diabetes superantigen pathway
Lead Indication · NB2-AD
Atopic dermatitis
33M Americans with AD. 6M underserved by current therapy. NB2 targets the S. aureus driver.
Patient funnel
From 33M to Phase 2 PoC trial-eligible
33M
6M
Steroid-intolerant
Topical steroids contraindicated due to toxicity
~1M
Active S. aureus infection
Overt skin infection requiring treatment
~200K
P2 PoC trial-eligible
Mod-severe AD + active S. aureus burden
Positioning vs. Dupixent
Topical convenience. Differentiated MoA.
DUPIXENT
IL-4Rα biologic (Sanofi/Regeneron)
$40,000
Injectable, every 2 weeks
NB2 (target)
Topical small-molecule NCE
$9,800
Topical, course-based
Schlievert (ADRN / NIH-funded) co-inventor — directly connects NB2 to the "atopic march" thesis and the leading academic network in AD.
Lead Indication · NB2-DFU
Diabetic foot ulcers
No breakthrough therapy in 60 years. NB2 attacks the S. aureus driver — and the superantigens that block wound healing.
~2M
US patients/yr
develop foot ulcers
$10B
Annual US cost
direct healthcare burden
30%
5-yr mortality
comparable to many cancers
60yr+
No breakthrough
in published trials
Why NB2 should work
01 · Pathogen
S. aureus drives DFU
The majority of DFUs are infected with S. aureus producing superantigens (Schlievert lab, JID 2014).
02 · Healing block
Superantigens block healing
Demonstrated in vitro and in vivo (Schlievert lab, Biochemistry 2015). Until S. aureus and its superantigens are cleared, the wound does not close.
03 · NB2 does both
The two-pronged action
NB2 kills S. aureus and inhibits superantigen synthesis at sub-MBC — the exact mechanism DFU requires.
Standard of care
Debridement + offloading + systemic antibiotics — no effective topical breakthrough therapy
Regulatory path
Topical NCE, 505(b)(1) NDA; QIDP / Breakthrough Designation explorability under evaluation
Endpoint
% wound closure at 12 weeks — well-validated, modest n required
Leadership
Founders and board with 15+ FDA approvals.
A team that has registered more than fifteen products with FDA generating over $3 billion in annual sales — applied to a novel chemical class with a real differentiator.
Chairman, Co-founder
Dayton Reardan, PhD, RAC
PhD, Physical Chemistry (UC Davis). 15+ FDA approvals incl. 6 NCEs; 50+ INDs filed. Inventor on 53+ patents. Two-time FDA Commissioner's Award.
CSO, Co-founder
Patrick Schlievert, PhD
Discovered TSST-1; described 29 toxin-mediated diseases. 500+ publications. Former Chair of Microbiology, U. Iowa. 30+ years S. aureus pathogenesis. Author on DFU mechanism papers.
Chief Financial Officer
Dan Saccani
Founder, Ravix Group. 30+ yrs startup CFO. Helped clients raise $2.3B+ VC and $400M+ debt; managed M&A from $100M–$1.4B and multiple IPOs.
Board Member
Paul Brennan, PhD
Professor of Medicinal Chemistry & Director, Centre for Medicines Discovery, U. Oxford. Ex-Pfizer/Amgen. 200+ publications; co-founder of two biotechs.
Board Member
Robert Klem, PhD
Founder/CEO, JBL Scientific (200+ GMP products). Ex-CTO, Genta — drove CMC/IP for Genasense; co-negotiated the $190M + $700M Aventis deal. 12 US/EU patents; multiple FDA approvals.
15+
FDA approvals registered
$3B+
Annual product sales
70+
Issued US patents
Intellectual Property
Three issued US patents.
Broad composition-of-matter and use claims covering the CAIT chemical class. International filings pending.
Issued · US
11,365,176
Composition of matter and use claims covering the CAIT chemical class.
Issued · US
11,572,342
Composition of matter and use claims covering the CAIT chemical class.
Issued · US
11,873,272
Composition of matter and use claims covering the CAIT chemical class.
Clinical development plan
✓
STAGE 1
Pre-IND
✓ May 2024
2
STAGE 2
IND filing
6–9 mo post-close
3
STAGE 3
Phase 1A
12 healthy vol.
4
STAGE 4
Phase 1B
36 AD patients
5
STAGE 5
Phase 2 PoC
114 patients
Pre-IND outcome — FDA Dermatology, May 22, 2024
PATHWAY
505(b)(1) NCE; 5-yr NCE exclusivity at approval
DESIGN
Phase 1A: 12 healthy volunteers, 2-week treatment, safety + PK
BRIEFING
Phase 1B + Phase 2 designs reviewed and broadly accepted
POSTURE
No major CMC or tox concerns flagged
DFU PATH
Parallel pre-IND meeting planned post-financing close
EXPEDITED
QIDP / Breakthrough explorability for DFU under evaluation
May 2024
Pre-IND meeting completed
FDA Dermatology was receptive and supportive of the AD development plan.
Feb 2025
Minipig dermal tox complete
NOAEL 25 mg/kg BID over 7 days, 10% BSA. Plasma 2–6 ng/mL.
Designation
New chemical entity
5-year NCE exclusivity available at approval. QIDP/Breakthrough explorability for DFU under evaluation.
The Opportunity
Two large, underserved markets. Platform optionality on top.
Atopic dermatitis — peak US revenue ramp
$6.5B
Y5 projection at 5% market share, $9,800/treatment, 6.6M moderate-to-severe AD patients with steroid intolerance / active S. aureus.
DFU opportunity context
$10B
Annual US healthcare cost of diabetic foot ulcers. No approved breakthrough topical therapy — pricing power and reimbursement leverage are significant.
~2M
Incident US patients/year
30%
5-year mortality
Comparable transactions
Eucrisa → Pfizer (Anacor)
$5.2B · 2016
Dermavant → Organon
$1.2B · 2024
Opzelura — Incyte derm franchise
Multi-billion franchise
Use of Proceeds
$13–15M to Phase 2 PoC across two tranches.
Capital-efficient at 5–10× comparable derm programs. ~$400K cash burn to date.
Total program · two tranches over 2–3 years
$13–15M
To advance NB2 through Phase 2 proof-of-concept in atopic dermatitis, with a parallel DFU pre-IND meeting and IND-enabling work.
Tranche 1 · IND + Phase 1A
$5M
GLP tox · CMC manufacture · IND filing · Phase 1A initiation
Catalyst: Phase 1A safety readout · ~14 months
→
Tranche 2 · Phase 1B + Phase 2 PoC
$8–10M
Phase 1B (36 AD pts) · Phase 2 PoC (114 pts) · GMP transfer
Catalyst: Phase 2 PoC topline · ~30 months
Use-of-proceeds shown is illustrative; final allocation set in definitive subscription documentation.
Open to qualified investors.
Niche is currently raising to advance NB2 through Phase 2 PoC. We welcome inquiries from accredited investors, family offices, and strategic partners aligned with anti-infective and dermatology programs.
Contact
Get in touch.
For data-room access, the investor brief, or to schedule an introductory call.
Inquiries
Office
22345 Bracketts Road
Shorewood, MN 55331 · USA
Shorewood, MN 55331 · USA
Entity
Niche Biopharmaceuticals Inc.Delaware corporation, doing business in Minnesota
Founder
Dayton T. Reardan, PhD, RACChairman & Founder
CSO
Patrick Schlievert, PhDChief Science Officer & Co-founder