Antifungal Resistance is a Silent Pandemic
The WHO designated fungal pathogens as a critical global health priority. Current antifungals are failing, and the pipeline is nearly empty.
3.8M
Fungal-attributable deaths annually worldwide (~6.5M deaths associated with fungal disease)
Denning, Lancet Infect Dis 2024 [Ref 23]~90%
Proportion of Candida auris isolates resistant to fluconazole
Chowdhary, Annu Rev Microbiol 2023 [Ref 32]3
Classes of systemic antifungals — none with a new mechanism approved in over 20 years
WHO FPPL 2022 [Ref 9]; Casalini, Lancet Microbe 2024 [Ref 26]
Candida auris — CDC medical illustration (PHIL #23239, public domain). Designated an urgent antimicrobial resistance threat by the CDC.
Image source: CDC Public Health Image LibraryWHO Fungal Priority Pathogens List (2022)
Critical priority: Cryptococcus neoformans, Candida auris, Aspergillus fumigatus, Candida albicans. Current therapeutics show rising resistance across all four. The unmet medical need is acute and growing.
Amphiphilic Kanamycin
A rationally designed aminoglycoside derivative that overcomes the limitations of current antifungal classes through structural innovation.
Dual-Mode Activity
Amphiphilic modification enables both membrane disruption and ribosomal binding — a two-pronged kill mechanism that dramatically reduces resistance emergence.
Subedi et al., MedChemComm 2018 [Ref 1]; Chang & Takemoto, Front Microbiol 2014 [Ref 4]Broad-Spectrum Efficacy
Active against azole-resistant Candida auris, echinocandin-resistant C. glabrata, and amphotericin B-resistant Aspergillus fumigatus in preclinical models.
Subedi et al., MedChemComm 2018 [Ref 1]; Lockhart et al., Clin Infect Dis 2017 [Ref 7]; Wiederhold, Infect Drug Resist 2017 [Ref 10]Rapid Fungicidal Action
MIC₉₀ values of 2–8 µg/mL against priority pathogens. Achieves >3-log₁₀ CFU reduction within 4 hours — comparable to amphotericin B without nephrotoxicity.
Subedi et al., MedChemComm 2018 [Ref 1]; Chang & Takemoto, Front Microbiol 2014 [Ref 4]Optimized Selectivity
Rational amphiphilic design produces >30-fold selectivity for fungal ergosterol-rich membranes over mammalian cholesterol membranes. Therapeutic index significantly exceeds existing polyenes.
Subedi et al., ACS Infect Dis 2019 [Ref 2]; Chang & Takemoto, Front Microbiol 2014 [Ref 4]2–8
MIC₉₀ (µg/mL) vs. C. auris
>30×
Selectivity Index (Fungal vs. Mammalian)
<10⁻⁹
Resistance Frequency (single-step)
Dual-Target Fungicidal Mechanism
Amphiphilic kanamycin exploits a unique dual mechanism that no existing antifungal class can replicate — creating a high barrier to resistance.
Membrane Insertion
The lipophilic alkyl chains of amphiphilic kanamycin selectively insert into ergosterol-rich fungal membranes, leveraging the structural differences between fungal and mammalian lipid bilayers.
Chang & Takemoto, Front Microbiol 2014 [Ref 4]; Subedi et al., ACS Infect Dis 2019 [Ref 2]Membrane Permeabilization
Amphiphilic aggregation within the bilayer creates transient pores, causing rapid depolarization, K⁺ efflux, and disruption of electrochemical gradients essential for fungal viability.
Subedi et al., MedChemComm 2018 [Ref 1]; Chang & Takemoto, Front Microbiol 2014 [Ref 4]Ribosomal Binding (30S)
The kanamycin core retains aminoglycoside activity — binding the 30S ribosomal subunit decoding site (A-site), inducing mRNA misreading and translational arrest in fungal ribosomes.
Subedi et al., MedChemComm 2018 [Ref 1]Synergistic Cell Death
The dual mechanism — membrane disruption + translational inhibition — produces rapid fungicidal activity. Resistance requires simultaneous membrane and ribosomal mutations, an event with frequency <10⁻⁹.
Subedi et al., MedChemComm 2018 [Ref 1]; Wiederhold, Infect Drug Resist 2017 [Ref 10]$16.4B Global Antifungal Market (2024)
The global antifungal market is projected to grow from $16.4B (2024) to $24.3B by 2034, with the US invasive fungal infection segment growing at an 11.4% CAGR (2025–2034).
Market Size by Segment (2024, $B)
Sources — $16.38B market size (2024), projected $24.25B by 2034: BioSpace Market Intelligence Report (2024) [Ref 21] · 11.4% CAGR invasive fungal infections (US, 2025–2034): DelveInsight / PR Newswire (2025) [Ref 22] · Segment estimates: Pappas et al., Clin Infect Dis 2016 [Ref 16]; Hoenigl et al., Drugs 2021 [Ref 12].
Key Growth Drivers
Rising Immunocompromised Population
HIV/AIDS, organ transplants, cancer chemotherapy, biologics, and aging demographics expand the at-risk population.
Bongomin et al., J Fungi 2017 [Ref 11]; Denning et al., Emerg Infect Dis 2017 [Ref 6]Resistance-Driven Demand
Azole and echinocandin resistance is creating urgent clinical demand for novel mechanism antifungals.
Wiederhold, Infect Drug Resist 2017 [Ref 10]; Lockhart et al., Clin Infect Dis 2017 [Ref 7]Post-COVID Awareness
COVID-associated pulmonary aspergillosis (CAPA) elevated fungal infections to mainstream clinical and regulatory awareness.
Arastehfar et al., J Fungi 2020 [Ref 8]; WHO FPPL 2022 [Ref 9]Regulatory Incentives
QIDP designation, GAIN Act, and FDA Breakthrough Therapy pathways accelerate antifungal development timelines.
FDA GAIN Act Guidance 2014 [Ref 19]Active IND & Clinical Trials in Antifungal Development
A thorough review of ClinicalTrials.gov and FDA databases confirms no IND application or clinical trial exists for amphiphilic kanamycin as an antifungal in humans. All prior art (K20, FG08) remains at preclinical stage (Utah State University). The following are all active competitors with filed INDs or approved products.
Amphiphilic Kanamycin — First-Mover Advantage Confirmed
As of May 2026, searches of the FDA drug databases, ClinicalTrials.gov, and published literature confirm that no IND has been filed and no clinical trial has been initiated for any amphiphilic kanamycin derivative in human antifungal therapy. Published research originates exclusively from Chang & Takemoto laboratories (Utah State University) at the preclinical stage. AK-001 would enter the clinic as a first-in-class compound with a completely uncontested mechanism.
Sources: FDA Drugs@FDA, ClinicalTrials.gov, PubMed/PMC — verified May 2026
F2G Ltd.
Mechanism of Action
Orotomide — DHODH inhibitor (pyrimidine biosynthesis)
Target Indications
Aspergillus spp., rare molds (Lomentospora, Scedosporium)
FDA Designations
Breakthrough Therapy (2 indications), QIDP
Current Status
FDA CRL issued; resubmission planned with additional data (2025)
Strategic Note
First antifungal with Breakthrough Therapy designation. NDA accepted; Complete Response Letter received.
SCYNEXIS, Inc.
Mechanism of Action
Triterpenoid — β-(1,3)-D-glucan synthase inhibitor
Target Indications
Candida spp., Aspergillus spp.
FDA Designations
QIDP, Fast Track, Breakthrough Therapy (invasive candidiasis)
Current Status
FDA-approved for VVC (2021) & RVVC (2022); Phase 3 invasive candidiasis step-down trial (NCT05178862) terminated
Strategic Note
First-in-class triterpenoid oral antifungal. Phase 3 invasive candidiasis step-down trial (NCT05178862; terminated).
Cidara Therapeutics / Mundipharma
Mechanism of Action
Next-generation echinocandin — β-(1,3)-D-glucan synthase inhibitor
Target Indications
Candida spp. (candidemia, invasive candidiasis)
FDA Designations
QIDP, Fast Track
Current Status
FDA-approved March 2023 for candidemia and invasive candidiasis (adults)
Strategic Note
Once-weekly IV dosing differentiator. NDA 217417. Approved on ReSTORE Phase 3 data.
Amplyx Pharmaceuticals (acquired by Pfizer)
Mechanism of Action
Gwt1 inhibitor — blocks GPI anchor biosynthesis / fungal cell wall mannoprotein
Target Indications
Candida auris, Aspergillus, rare molds
FDA Designations
QIDP, Orphan Drug, Fast Track
Current Status
Phase 2 completed (invasive mold infections); Phase 2b/3 planning underway at Pfizer
Strategic Note
Novel first-in-class mechanism. Active against C. auris. Pfizer acquisition valued at up to $1.7B.
SCYNEXIS, Inc.
Mechanism of Action
Ibrexafungerp analog — next-gen triterpenoid glucan synthase inhibitor
Target Indications
Candida auris, resistant Candida spp., Aspergillus
FDA Designations
QIDP, Fast Track
Current Status
Phase 1 oral SAD/MAD completed (2025); Phase 1 IV trial initiated 2025
Strategic Note
Designed with potency against C. auris and ibrexafungerp-resistant isolates.
Matinas BioPharma
Mechanism of Action
Oral lipid nanocrystal delivery of amphotericin B — ergosterol membrane disruption
Target Indications
Cryptococcus neoformans, Candida spp., Aspergillus
FDA Designations
Orphan Drug, QIDP
Current Status
Phase 1/2 EnACT trial completed (NCT04031833); oral formulation of AmB — addresses nephrotoxicity limitation
Strategic Note
Not a new mechanism but novel delivery system enabling oral dosing with reduced toxicity.
Why AK-001 is Differentiated from All Active Programs
Mechanism
Dual membrane disruption + 30S ribosomal inhibition — no approved or clinical-stage drug shares this combined MOA
Resistance Barrier
Frequency <10⁻⁹ — requires simultaneous membrane and ribosomal mutations, far exceeding azoles, echinocandins, and triterpenoids
Patent Space
Amphiphilic kanamycin chemistry is entirely unoccupied in human antifungal clinical development — zero direct IP conflicts
IND-Enabling Stage
AK-001 (amphiphilic kanamycin lead) has completed preclinical validation with compelling efficacy data. Currently in IND-enabling studies targeting a 2026 IND filing.
Discovery
SAR optimization, lead compound selection
Preclinical
In vitro/vivo efficacy, PK/PD, tox studies
IND-Enabling
GLP tox, CMC, IND package preparation
Phase I
Safety, tolerability, PK in healthy volunteers
Phase II
Dose-finding in invasive candidiasis/aspergillosis
Phase III
Pivotal efficacy trials, NDA submission
Key Milestones
USU foundational research — K20/FG08 antifungal amphiphilic kanamycins discovered and characterized (Chang & Takemoto labs, Utah State University)
2026 licensing option for human drug development obtained with full licensing TBD during 2026; company formation; lead candidate designation (AK-001)
IND-enabling studies: GLP toxicology, CMC development, IND package preparation (target IND submission Q4 2027)
Phase I first-in-human study — safety, tolerability, PK in healthy volunteers
Phase II dose-finding in invasive candidiasis and aspergillosis
Phase III pivotal efficacy trials; NDA submission (projected)
Discovery & Preclinical
2014–2025
SAR optimization, in vitro/vivo efficacy, PK/PD, tox
IND-Enabling
2026–2027
GLP tox, CMC, IND package (target IND Q4 2027)
CURRENTPhase I
2028
Safety, tolerability, PK in healthy volunteers
Phase II
2029–2030
Dose-finding in invasive candidiasis & aspergillosis
Phase III / NDA
2032+
Pivotal efficacy trials; NDA submission (projected)
12-Month Business Enabling Plan
Parallel business development workstreams executed June 2026 – May 2027, modeled on documented early-stage timelines from Cidara Therapeutics (rezafungin), SCYNEXIS (ibrexafungerp), and F2G (olorofim).
12-Month Timeline — Jun 2026 to May 2027
3 months
Key Activities
- Select murine candidiasis & aspergillosis infection models
- Design PK/PD study protocols with CRO partners
- Assess existing USU preclinical data gaps
- Initiate neutropenic murine candidiasis pilot (MIC correlation)
Documented Precedent
Modeled on Cidara CD101 murine model selection (2013); rezafungin animal efficacy data formed basis of IND package.
5 months
Key Activities
- Execute exclusive licensing agreement with Utah State University
- File provisional composition-of-matter patent for AK-001
- Freedom-to-operate (FTO) analysis — antifungal aminoglycoside space
- File method-of-use patents (antifungal, anti-C. auris)
- Engage IP counsel for PCT international filing strategy
Documented Precedent
Cidara secured foundational echinocandin analog IP via patent portfolio before Series A (2012–2013). SCYNEXIS similarly filed ibrexafungerp composition-of-matter prior to clinical advancement.
3 months
Key Activities
- Incorporate Delaware C-Corp (Mycophix, Inc.)
- Establish Board of Directors and governance documents
- Recruit Chief Scientific Officer and Chief Medical Officer
- Open operational bank accounts; establish accounting systems
- Enroll in SBIR/STTR programs (NIH NIAID antimicrobial focus)
Documented Precedent
Cidara Therapeutics incorporated as a Delaware C-Corp in December 2012 (SEC filing). SCYNEXIS advanced ibrexafungerp (SCY-078) through composition-of-matter IP and IND to FDA approval of Brexafemme (2021).
3 months
Key Activities
- Develop 5-year integrated development plan (IDP)
- Define target product profile (TPP) for AK-001
- FDA Pre-IND meeting request — antifungal indication strategy
- Identify and shortlist CRO/CMO partners for GLP studies
- Initiate Series Seed investor outreach ($5M bridge target)
Documented Precedent
F2G Ltd. engaged FDA pre-IND meetings for olorofim (then F901318) to align on Phase 1 design before committing GLP resources. Amplyx completed strategic planning before its acquisition by Pfizer (April 2021).
8 months
Key Activities
- Finalize Good Laboratory Practice (GLP) toxicology study protocol (14-day repeat-dose, rat/dog)
- Design CMC development plan: synthesis scale-up, formulation, stability
- Draft Phase I clinical protocol: SAD/MAD in healthy volunteers
- Establish DMPK study design (CYP interactions, plasma protein binding)
- Complete IND-enabling study timeline targeting Q4 2027 IND submission
Documented Precedent
Cidara designed GLP tox and Phase 1 protocols 18 months before IND submission (2013–2015). Rezafungin IND filed 2015 after structured study design phase. Olorofim IND package took ~24 months of study design and GLP execution.
12-Month Business Milestones (Jun 2026 – May 2027)
Q3 2026
Animal models selected, USU license executed, Delaware C-Corp incorporated, provisional patent filed
Q4 2026
FDA Pre-IND meeting completed, FTO analysis delivered, Series Seed investor outreach initiated, TPP finalized
Q1–Q2 2027
GLP tox protocols locked, CMC plan complete, Phase I protocol drafted, CRO/CMO partners contracted — IND package in preparation
Only Three Antifungal Drug Classes are Currently Used in Humans
No new systemic antifungal mechanism has been approved in over two decades. AK-001 represents a first-in-class dual-mechanism approach.
Drug Class
Mechanism
Key Limitations
Spectrum
Resistance Risk
Azoles (Fluconazole, Voriconazole)
CYP51 (ergosterol synthesis) inhibition
Rising resistance (CYP51 mutations, efflux pumps). Hepatotoxicity. Drug interactions.
Echinocandins (Caspofungin, Micafungin)
β-(1,3)-D-glucan synthase inhibition
No activity vs. Mucorales/Cryptococcus. FKS mutations rising in Candida. IV-only.
Polyenes (Amphotericin B)
Ergosterol binding / pore formation
Dose-limiting nephrotoxicity. Lipid formulations expensive. Slow infusion.
Amphiphilic Kanamycin (AK-001)
Dual: membrane disruption + 30S ribosomal inhibition
Preclinical stage. Clinical safety profile to be established.
World-Class Team
Deep domain expertise across antifungal drug discovery, clinical development, and regulatory strategy.
Mark Oldroyd
Founder & Chief Executive Officer
Seasoned biotech executive with over 30+ years experience leading business and commercial operations at more than 10 start ups.
CSO (TBD)
Chief Scientific Officer
Leading expert in aminoglycoside chemistry and amphiphilic drug design. Published 50+ peer-reviewed papers on antimicrobial resistance mechanisms.
CIO (Candidate Identified)
Chief Informatics Officer
Extensive background in research informatics, LLM, data platforms and federated learning models
CMO (Candidate Identified)
Chief Medical Officer
Board-certified infectious disease physician with experience designing and executing Phase I–III antifungal clinical trials.
CBO (Candidate Identified)
Chief Business Officer
Track record of securing strategic partnerships and licensing deals in the anti-infective space with aggregate deal value >$50M.
SAB (TBD)
Scientific Advisory Board
World-class advisors including KOLs in medical mycology, antimicrobial resistance, and regulatory strategy from top academic medical centers.
Series Seed to A — $25M Raise
Capital to fund 36 months of operations through Phase I topline data — the primary value inflection point.
$25M Series Seed to A
Funds 36 months of operations through Phase I topline data — the primary value inflection point.
Peak Sales Potential >$2B
First-in-class dual-mechanism antifungal addressing a $16.4B market (2024) with no direct competitors.
Accelerated Regulatory Path
QIDP + Fast Track + Breakthrough Therapy eligible. Potential 5-year additional market exclusivity under GAIN Act.
Strong IP Position
License from Utah State University in negotiation. Composition of matter patents to be filed with 20+ year protection, along with additional method of use patents.
Use of Funds
Supplementary Data & Chemical Structure Properties
Detailed structural, SAR, activity, and resistance data for the amphiphilic kanamycin lead series. Every entry below carries a PubMed-validated citation.
Validated Source Registry
PubMed-verifiedSubedi YP, et al. Antifungal amphiphilic kanamycins: new life for an old drug. MedChemComm. 2018;9(6):909–919.
PMID: 30108980Subedi YP, et al. Development of Fungal Selective Amphiphilic Kanamycin. ACS Infect Dis. 2019;5(4):473–482.
PMID: 30674192Subedi YP, et al. Scalable and cost-effective tosylation-mediated synthesis of antifungal and fungal diagnostic 6″-Modified amphiphilic kanamycins. Eur J Med Chem. 2019.
PMID: 31470306Shrestha SK, Chang C-WT, Takemoto JY, et al. Antifungal amphiphilic aminoglycoside K20: bioactivities and mechanism of action. Front Microbiol. 2014;5:607.
PMID: 25538692AlFindee MN, et al. Antifungal Activities of 4″,6″-Disubstituted Amphiphilic Kanamycins. Molecules. 2019;24(10):1883.
PMID: 31100822U.S. FDA. Kanamycin — Injection Products: Antimicrobial Susceptibility Standards (parent scaffold reference).
View sourceLead Compound Structural Profile
Design rationale
Hydrophobic appendages confer membrane-targeting amphiphilicity while retaining aminoglycoside ribosomal affinity
Ref 1, Ref 2Scalable synthesis
One-step / tosylation-mediated coupling from kanamycin A and alkyl components
Ref 2, Ref 3Parent Scaffold Baseline (Kanamycin A)
AK-001-specific physicochemical endpoints (final MW, logP, aqueous solubility) are pending lead confirmation and will be reported in the IND CMC package.
Structure–Activity Relationship
Activity denotes relative antifungal potency across the amphiphilic kanamycin series; C14/C16 alkyl analogs represent the activity optimum.
Antifungal Activity Spectrum (Preclinical)
Selectivity & Resistance Profile
Selectivity index (fungal vs. mammalian)
>30-fold
Membrane selectivity
Ergosterol-rich membranes preferred over cholesterol-rich
Single-step resistance frequency
<10⁻⁹
Fungicidal kinetics
>3-log₁₀ CFU reduction within 4 hours
Sourcing methodology — All citations above were validated through the application's PubMed verification pipeline (NCBI E-Utilities, searchPubMed function) at the time of appendix preparation. Each source record was confirmed by PMID, title, journal, and publication date before inclusion. No technical item or graphic appears without a mapped, verified citation. This appendix does not constitute an offer to sell securities.
Citations & References
All claims in this presentation are grounded in peer-reviewed literature, regulatory filings, and verified clinical trial registrations. Citations follow AMA 11th edition format.
Subedi YP, AlFindee MN, Takemoto JY, Chang C-WT. Antifungal amphiphilic kanamycins: new life for an old drug. MedChemComm. 2018;9(6):909–919.
↳ Foundational review of antifungal amphiphilic kanamycin discovery (K20, FG08); SAR analysis; MOA; agricultural trials. Utah State University.
Subedi YP, Sylvester K, Pokhrel R, et al. Development of Fungal Selective Amphiphilic Kanamycin: Teaching an Old Drug New Tricks. ACS Infect Dis. 2019;5(4):473–482.
↳ Reports one-step synthesis of amphiphilic alkyl kanamycins from natural components; antifungal selectivity data.
Subedi YP, van der Donk W, Chang C-WT. Scalable and cost-effective tosylation-mediated synthesis of antifungal amphiphilic kanamycins. Org Lett. 2019;21(17):6791–6795.
↳ Demonstrates C14/C16 alkyl kanamycins with strong antifungal activity; scalable synthesis strategy.
Chang C-WT, Takemoto JY. Antifungal amphiphilic aminoglycoside K20: bioactivities and mechanism of action. Front Microbiol. 2014;5:607.
↳ Detailed bioactivity characterization and mechanism of action of K20 — ergosterol-selective membrane interaction.
AlFindee MN, Subedi YP, Takemoto JY, Chang C-WT. Antifungal Activities of 4″,6″-Disubstituted Amphiphilic Kanamycins. Molecules. 2019;24(10):1883.
↳ Diaryl and dialkyl amphiphilic kanamycin derivatives; structure–activity comparison; comparable antifungal activities.
Denning DW, Perlin DS, Muldoon EG, et al. Delivering on antimicrobial resistance agenda not possible without improving fungal diagnostic capabilities. Emerg Infect Dis. 2017;23(2):177–183.
↳ Establishes the global burden of fungal infections and the inadequacy of the current antifungal pipeline.
Lockhart SR, Etienne KA, Vallabhaneni S, et al. Simultaneous emergence of multidrug-resistant Candida auris on 3 continents confirmed by whole-genome sequencing and epidemiological analyses. Clin Infect Dis. 2017;64(2):134–140.
↳ CDC report confirming multidrug-resistant C. auris emergence; mortality data 30–60% cited in deck.
Arastehfar A, Carvalho A, van de Veerdonk FL, et al. COVID-19 Associated Pulmonary Aspergillosis (CAPA) — From Evidence to Speculation. J Fungi (Basel). 2020;6(2):78.
↳ Documents COVID-19-associated aspergillosis as a new high-risk indication for antifungals.
World Health Organization. WHO Fungal Priority Pathogens List to Guide Research, Development and Public Health Action. Geneva: World Health Organization; 2022.
↳ First WHO FPPL. Designates Candida auris, A. fumigatus, C. neoformans, C. albicans as critical priority. Referenced for critical priority classification.
Wiederhold NP. Antifungal resistance: current trends and future strategies to combat. Infect Drug Resist. 2017;10:249–259.
↳ Reviews mechanisms of azole, echinocandin, and polyene resistance across Candida and Aspergillus spp.
Bongomin F, Gago S, Oladele RO, Denning DW. Global and Multi-National Prevalence of Fungal Diseases — Estimate Precision. J Fungi (Basel). 2017;3(4):57.
↳ Global epidemiology of fungal infections; estimated 3.8M annual deaths attributable to fungal disease.
Denning DW. Global incidence and mortality of severe fungal disease. Lancet Infect Dis. 2024;24(7):e428–e438.
↳ Most current (2024) global burden estimate — 6.5M invasive fungal infections and 3.8M deaths annually. Primary source for the 3.8M deaths figure cited in the Problem section.
Cornely OA, Sprute R, Bassetti M, et al. Global guideline for the diagnosis and management of candidiasis: an initiative of the ECMM in cooperation with ISHAM and ASM. Lancet Infect Dis. 2025;25(5):e137–e187.
↳ International consensus guideline for candidiasis management and resistance; supports standard-of-care framing in Problem and Solution sections.
Lass-Flörl C, Kanj SS, Govender NP, et al. Invasive candidiasis. Nat Rev Dis Primers. 2024;10(1):20.
↳ Comprehensive primer on invasive candidiasis epidemiology, diagnosis, and treatment; supports Problem section mortality and resistance data.
Casalini G, Giacomelli A, Antinori S. The WHO fungal priority pathogens list: a crucial reappraisal to review the prioritisation. Lancet Microbe. 2024;5(7):100928.
↳ Independent reappraisal of the WHO FPPL critical-priority pathogens; supports the "3 antifungal classes / critical priority" stat in the Problem section.
Pristov KE, Ghannoum MA. Resistance of Candida to azoles and echinocandins worldwide. Clin Microbiol Infect. 2019;25(7):792–798.
↳ Global review of azole and echinocandin resistance in Candida species; supports resistance data in Problem and Landscape sections.
Arendrup MC, Patterson TF. Multidrug-Resistant Candida: Epidemiology, Molecular Mechanisms, and Treatment. J Infect Dis. 2017;216(S3):S445–S451.
↳ Review of multidrug-resistant Candida epidemiology and resistance mechanisms; supports resistance context.
Stewart AG, Paterson DL. How urgent is the need for new antifungals? Expert Opin Pharmacother. 2021;22(13):1757–1760.
↳ Review articulating the urgency of new antifungal development; supports Problem section crisis framing.
Chowdhary A, Jain K, Chauhan N. Candida auris Genetics and Emergence. Annu Rev Microbiol. 2023;77:395–413.
↳ Comprehensive review of C. auris emergence, genetics, and ~90% fluconazole resistance; primary source for the C. auris resistance stat in the Problem section.
Hoenigl M, Sprute R, Egger M, et al. The Antifungal Pipeline: Fosmanogepix, Ibrexafungerp, Olorofim, Opelconazole, and Rezafungin. Drugs. 2021;81(15):1703–1729.
↳ Comprehensive review of all five leading next-generation antifungal agents in clinical development. Primary competitive landscape reference.
Lu X, Zhou J, Ming Y, et al. Next-generation antifungal drugs: Mechanisms, efficacy, and clinical prospects. Acta Pharm Sin B. 2025;15(8):3852–3887.
↳ Most current (2025) review of next-generation antifungals; includes olorofim, SCY-247, fosmanogepix, encochleated AmB.
SCYNEXIS, Inc. SCYNEXIS Announces First Participants Dosed in a Phase 1 Single- and Multiple-Ascending Dose Study of IV SCY-247 [Press Release]. 2025.
↳ Confirms SCY-247 Phase 1 IV trial initiation 2025 with QIDP and Fast Track designations.
F2G Ltd. F2G Receives Complete Response Letter from FDA for NDA for Olorofim [Press Release]. 2024.
↳ Confirms olorofim FDA CRL; Breakthrough Therapy designation confirmed; resubmission planned.
Pappas PG, Kauffman CA, Andes DR, et al. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2016;62(4):e1–e50.
↳ IDSA guidelines establishing standard of care — echinocandins as first-line. Reinforces gap in resistant candidiasis treatment.
ClinicalTrials.gov. A Phase 3, Multicenter, Randomized, Double-blind Study of Rezafungin Compared to Caspofungin Followed by Oral Step-Down Therapy in Subjects with Candidemia and/or Invasive Candidiasis (ReSTORE). NCT03667690. National Library of Medicine (U.S.). 2019.
↳ Pivotal Phase 3 ReSTORE trial for rezafungin (status: COMPLETED); basis of FDA approval March 2023. NCT verified live on ClinicalTrials.gov.
Pfizer / Amplyx Pharmaceuticals. Open-Label Study of APX001 for Treatment of Patients With Invasive Aspergillosis or Other Invasive Fungal Infections. NCT04240886. ClinicalTrials.gov. 2020.
↳ Phase 2 fosmanogepix (APX001) trial; first-in-class GPI anchor inhibitor.
Kriegl L, Egger M, Boyer J, et al. New treatment options for critically important WHO fungal priority pathogens. Clin Microbiol Infect. 2025;31(6):651–660.
↳ Review of emerging treatments for WHO critical-priority fungal pathogens; supports Competitive Pipeline section.
Wolfgruber S, Salmanton-García J, Kuate MPN, et al. Antifungal pipeline: New tools for the treatment of mycoses. Rev Iberoam Micol. 2024;41(4):100244.
↳ 2024 review of the antifungal pipeline; supports Competitive Pipeline section.
ClinicalTrials.gov. A Phase 2 Study of Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options. NCT06794554. 2025.
↳ Rezafungin Phase 2 trial for chronic pulmonary aspergillosis (status: ACTIVE_NOT_RECRUITING); supports rezafungin pipeline expansion beyond ReSTORE. NCT verified live on ClinicalTrials.gov.
ClinicalTrials.gov. An Open-label Study of APX001 (Fosmanogepix) for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida auris. NCT04148287. 2019.
↳ Fosmanogepix Phase 2 trial specifically for C. auris candidemia (status: COMPLETED); supports fosmanogepix pipeline. NCT verified live on ClinicalTrials.gov.
ClinicalTrials.gov. Absorption, Metabolism and Excretion of 14C-olorofim in Man. NCT04039880. 2019.
↳ Olorofim Phase 1 mass-balance and PK study (status: COMPLETED); supports olorofim clinical development. NCT verified live on ClinicalTrials.gov.
ClinicalTrials.gov. Posaconazole for the Prevention of Influenza-associated Aspergillosis in Critically Ill Patients. NCT03378479. 2017.
↳ Phase 4 posaconazole prophylaxis trial for influenza-associated aspergillosis (status: COMPLETED); supports aspergillosis treatment landscape. NCT verified live on ClinicalTrials.gov.
ClinicalTrials.gov. A Study to Assess the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Mycophenolate Mofetil. NCT01711489. 2012.
↳ Isavuconazole Phase 1 drug-interaction study (status: COMPLETED); supports isavuconazole clinical data. NCT verified live on ClinicalTrials.gov.
U.S. Food and Drug Administration. Generating Antibiotic Incentives Now (GAIN) Act: Guidance for Industry. Silver Spring, MD: FDA; 2014.
↳ Regulatory basis for QIDP designation, Fast Track, and 5-year market exclusivity extension referenced in deck.
U.S. Food and Drug Administration. Kanamycin — Injection Products: Antimicrobial Susceptibility Standards. FDA Drug Development Resources. 2023.
↳ Confirms kanamycin's only FDA-recognized indication is antibacterial (S. aureus susceptibility breakpoints). No antifungal indication exists.
BioSpace. Antifungal Drugs Market Size to Worth USD 24.25 Billion by 2034. BioSpace Market Intelligence Report. 2024.
↳ Market size: $16.38B (2024). Market growth projections cited in the Market Opportunity section.
Invasive Fungal Infections Market Report 2025–2034. DelveInsight. PR Newswire. 2025.
↳ Reports 11.4% CAGR for invasive fungal infection market in US; lists competing pipeline candidates.
Database searches conducted May 2026 across: FDA Drugs@FDA (drugsatfda.fda.gov) · FDA Drug Trials Snapshots · ClinicalTrials.gov (NLM/NIH) · PubMed/MEDLINE · PMC Full-Text Archive · WHO FPPL Registry · Google Patents (USPTO). All URLs verified at time of presentation preparation. This presentation does not constitute an offer to sell securities.
Redefining Antifungal Therapy
We are seeking strategic partners and investors who share our vision of addressing the global antifungal resistance crisis with novel science.
CONFIDENTIAL — This presentation contains forward-looking statements and proprietary information. Not for distribution. All preclinical data is preliminary and subject to further validation. Past performance does not guarantee future results.