NASDAQ: TTRX

Our Solutions

We are seeking new drug approvals
for the GX-03 formula as a treatment for both eczema and onychomycosis, two skin conditions which require FDA drug approval for marketing.
The drug candidate is based on GX-03’s inclusion of polyhexanide (“PHMB”), a well-characterized polymer that, despite
its long history of being well-tolerated in wound care, has never been formally submitted or approved as an API for a drug product within
the United States. This API has demonstrated strong antimicrobial, anti-inflammatory, and newly discovered upstream and downstream immunomodulating
properties, and has an established safety profile with no known adverse effects. We are pursuing its use as a drug active in indications
such as inflammatory skin diseases and fungal nail infections. PHMB has no demonstrated or documented systemic uptake in humans.

Our proposed drug formulation
for GX-03 is identical to the formula employed in previously cleared medical devices. It has the same active ingredient concentration,
petrolatum base, and employs the same proprietary mixing process. Our decision to pursue indications in eczema and onychomycosis is supported
by physician feedback and case studies, as discussed below, as well as sponsor initiated in-vivo and in-vitro data. We believe such signals,
along with PHMB’s well-documented antimicrobial and anti-inflammatory properties, which have been validated by scientific literature
and in-vivo studies, form a sound scientific basis for cross-indication effectiveness across these two dermatologic conditions.

Our founder obtained 510(k)
FDA clearance for the GX-03 formula under product category FRO in November 2016 (K160872). To achieve this clearance, extensive animal,
laboratory and manufacturing testing was conducted to demonstrate that the formula was as well-tolerated and effective as “predicate
products” with comparable form and function. Additional 510(k) clearance was granted in August 2017 (K171191) to manage the skin
and symptoms of various skin conditions, including atopic, irritant, and radiation dermatitis. In October 2019, a third clearance was
obtained for a porous antimicrobial gauze saturated with the GX03 formula (K183681), following further testing, including packaging and
sterilization validations.

In 2020, our founder developed
the FleX Product, designed for use in wound and burn care. The rights to this medical device formulation were licensed to MiMedx prior
to FDA clearance. MiMedx subsequently elected to pursue a De Novo classification pathway for truly novel innovations rather than a traditional
510(k) route and assumed responsibility for all remaining product testing and regulatory interactions for the FleX Product. For more information
with respect to the license agreement with MiMedx, see “- Marketing - MiMedx Agreement.”

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Our current business model
is to license and/or sell medical device products through commercial partners, without significant capital commitments from us, which
allows us to focus our internal efforts on drug development. From 2017 to 2019, GX-03 was commercially distributed by McKesson for wound
care. Following physician reports and case studies suggesting positive outcomes in patients with eczema and onychomycosis, we voluntarily
ceased internal wound care sales in 2019 to pursue new drug approvals related to these results. We continue to explore additional licensing
opportunities for device applications. We have recently completed a license and supply agreement with Medline with respect to K183681
and other wound care opportunities, as well as antimicrobial personal care/OTC products to be jointly developed. We maintain a business
model that strategically leverages contractors and vendors while employing a comparatively small internal team in order to minimize cash
burn. We believe this reduces the amount of cash needed for internal operations, reduces waste and results in a larger proportion of available
capital that can be spent toward furthering clinical development.

Core Products and Programs

GX-03 for Moderate-to-Severe Eczema
(Lead Program)

GX-03 is a non-systemic topical
immunomodulator being clinically developed for moderate-to-severe eczema. Preclinical studies demonstrated inhibition of cytokines associated
with inflammatory skin disease, including IL-31, IL-36α/γ, and IL-4. GX-03 is currently being evaluated in a randomized, double-blind,
vehicle-controlled clinical trial in adults with moderate-to-severe eczema.

An interim assessment will
be performed at approximately 50% trial completion. An independent interim assessment committee (“IAC”) will review emerging
signals of tolerability and efficacy. The IAC is empowered to deliver pre-written statements regarding conditional probability of a statistically
significant favorable trial outcome, as well as increase the sample size up to 200% if the committee sees a strong likelihood of achieving
statistical significance based upon positive trending. This adaptive trial design, due to the independence of the committee, pre-established
rights, and pre-written statements the committee is permitted to deliver after deliberating, does not increase the likelihood of primary
error and/or expend alpha.

GX-03 for Onychomycosis

GX-03 is also being advanced
as a topical treatment for onychomycosis. In-vivo studies in a validated animal model demonstrated nail-plate penetration and reduction
of fungal burden within the nail. Additional clinical program steps are expected to follow completion of the eczema clinical program and
related IND activities.

Medical Device Products (Wound
and Dermatitis Management)

The company has previously
developed and obtained FDA clearance for several medical device formulations containing the same base formulation used in GX-03:

●
K183681: a porous
antimicrobial gauze impregnated with the GX-03 formulation. The product has recently been licensed to Medline under a license and supply
agreement.

●
K160872: a device cleared for acute
and chronic wound management.

●
K171191: a device cleared to manage
the skin and symptoms of atopic, irritant, and radiation dermatitis.

These medical devices provide
historical real-world usage experience but are not the focus of current clinical development efforts.

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Thermostable Intranasal Vaccine
Platform (Exploratory Program)

The company continues to
conduct exploratory research into the use of its formulation process for live vaccine stabilization and nasal application. This program
remains early-stage and operates independently of the dermatology development programs.

PIND Meetings Summary and Drug
Programs:

The FDA has provided a potential
regulatory pathway for GX-03’s drug development programs. Following two early PIND meetings to discuss clinical development programs
for conditions of the nails and skin (PIND 137155 and PIND 138686 on January 17, 2018 and May 9, 2018, respectively), the FDA communicated
an openness to the Company leveraging existing 510(k) clinical data to bypass Phase 2 studies.

Electively, the Company chose
to sponsor an approximately 114-patient double-blind, randomized, vehicle-controlled trial within the United States in moderate-to-severe
eczema to provide insight into Phase 3 design and clinical signal. Patient dosing commenced in mid-July 2025. While we have obtained and
are actively completing CMC work required for IND submission, we are able to conduct this trial with significant cost savings by utilizing
the existing 510(k) clearance (K171191) for the candidate formula (GX-03), which permits its use on human subjects with atopic dermatitis.
Although we are running this trial as a Phase 2-equivalent, we are simultaneously leveraging the cleared status of the formulation. As
such, this trial was deemed low-risk and required institutional review board approval rather than an active IND. This trial is designed
to (i) generate high-quality tolerability and efficacy data that, if successful, we expect to include in an IND package to support a Phase
3 study and (ii) provide insight to stakeholders regarding the clinical efficacy of our product candidate.

At the conclusion of this
study and subsequent regulatory interaction(s), our present plan is to advance to Phase 3 trials for moderate-to-severe eczema following
a meeting with the FDA to discuss the data and development plan(s). We intend to conduct additional nonclinical and clinical studies,
such as PK max-use and additional healthy volunteer exposure trials, and anticipate requesting permission to conduct such studies in parallel
with Phase 3 trials.

The Company also intends
to initiate additional clinical development of GX-03 for onychomycosis. The clinical development of topical therapies for onychomycosis
benefits from a well-established body of regulatory precedent, including defined endpoints, validated trial designs, and historical comparators.
While the Agency previously communicated potential openness to advancing the onychomycosis program directly into Phase 3 trials, in light
of evolving regulatory openness to a single adequate and well-controlled registrational study, the Company may elect to structure such
a single registrational trial as an adaptive Phase 2b/3 study within a single development framework. The Company may also initiate certain
foundational clinical activities for onychomycosis in select ex-U.S. jurisdictions with clinically respected regulatory environments,
while IND preparation and U.S. site activation for this indication continue. This approach is intended to support alignment of global
development timelines for the onychomycosis program while preserving optionality as the Company engages with the FDA on its overall development
strategy.

Clinical Highlights for GX-03:

GX-03 has demonstrated broad
upstream cytokine inhibition in preclinical models of inflammatory skin disease, including IL-31, IL-36α/γ, and IL-4. These
findings correspond to pathways implicated in eczema pathophysiology. In animal studies, treatment with GX-03 resulted in significant
reductions in Investigator’s Global Assessment (IGA) scores and suppression of inflammatory signaling.

Additional in-vivo work demonstrated
nail penetration and antifungal activity relevant to onychomycosis. Across these programs, GX-03 demonstrated a favorable tolerability
profile with no observed systemic exposure.

Vaccine Delivery Platform

In addition to our dermatology
programs, we are actively advancing vaccine delivery technologies through our PermaFusion suspension platform aimed at extending the ambient
and refrigerated stability of live vaccines. If successful, this technology will enable critical vaccines to be delivered intranasally
without injection which, alongside increased stability, may enable the delivery of immunizations to patients in clinic, hospital, and
home-health settings.

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In May 2025, we achieved
a key technical milestone: the successful 100% recovery of a live VSV vaccine vector from our oil-based delivery system. Viral vectors
are base viruses used to make vaccines via strategic modifications. We established that we could recover 100% of this VSV vector suspended
in our carrier at 72 hours at room temperature, with all of the VSV being “recovered,” a measurement term for surviving. These
findings suggest that lipid-enveloped live viruses may remain viable in our viscous suspension system without degradation, thereby offering
preliminary evidence that challenges prior assumptions about incompatibility between lipid carriers and live, lipid-enveloped viruses.

On June 6, 2025, we began
a parallel stability analysis of a live, VSV-based vaccine candidate (suspended in our carrier) and the same vaccine in traditional, solution
form. Both forms, along with an unmodified VSV control, were stored at ambient temperature and refrigerated (4°C) for 28 days. Evaluations
of viability took place at 3, 7, 14, and 28 days. That trial has been completed and produced results demonstrating that the live vaccine
in our delivery system was 100% recoverable at up to 14 days in ambient storage and 100% recoverable at up to 28 days in refrigerated
storage.

Competitive Strengths

Non-Systemic Cytokine Modulation
for Inflammatory Skin Disease

GX-03 has demonstrated inhibition
of cytokines associated with inflammatory skin disease without evidence of systemic uptake. This approach is intended to enable topical
immunomodulation without systemic immunosuppression or injectable administration.

Proprietary Platform Technology
Enabling Broad Formulation Capabilities Across Multiple Therapeutic Categories

The company’s formulation
process enables suspension of water-soluble actives in oil-based carriers without emulsifiers, supporting uniform delivery and stability.

Improved Therapeutic Profile for
Onychomycosis and Other Dermatologic Indications

Current topical therapies
for onychomycosis, such as Jublia® (efinaconazole), are associated with long treatment durations, low complete cure rates (often
below 20% in real-world use), and limited penetration into the nail bed. Oral antifungals offer better efficacy but carry systemic risks,
including hepatotoxicity, drug interactions, and the need for liver monitoring. Our topical antifungal product candidate, developed using
the PermaFusion platform, is designed to overcome these limitations by enhancing delivery through the nail plate while avoiding systemic
exposure. We believe our candidate represents a potentially attractive topical therapy with a differentiated tolerability and efficacy
profile.

Needle-Free, Non-Systemic Approach
Aligned with Patient and Caregiver Preferences

There is increasing demand - particularly
among pediatric, geriatric, and chronic care populations - for therapies that avoid injections, steroids, and systemic immunosuppression.
Our pipeline is focused on non-steroidal, non-injectable, and non-biologic product candidates with localized activity. This approach is
intended to maximize safety and convenience without compromising therapeutic effect, addressing a growing preference for treatments that
are easier to administer and better tolerated over long-term use.

Immunomodulatory Activity Without
the Cost and Risks of Biologics

Many immunomodulatory therapies
rely on injectable and topical biologics that target pathways such as IL-4, IL-13, IL-31, and IL-36. While these agents tend to show effectiveness
in clinical trials, they come with tradeoffs: high cost, systemic immunosuppression, higher incidence of side effects, and, for injectables,
low patient adherence due to injection burden. Our non-biologic, non-systemic candidates have demonstrated cytokine modulation without
the need for injections or systemic absorption. Cytokine modulation refers to the alteration - either reduction, increase,
or normalization - of the levels of signaling proteins (cytokines) that regulate immune and inflammatory responses. In inflammatory
skin diseases such as eczema, certain cytokines (e.g., IL-36α, IL-36γ, IL-31, and IL-4) are overproduced, driving redness, swelling,
and itch. Modulating these cytokines can reduce the inflammatory response and improve disease symptoms.

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GX-03 has demonstrated cytokine
modulation in pre-clinical (animal) studies. In a murine model of Staphylococcus aureus-induced eczema, topical pretreatment with GX-03
significantly reduced protein expression of IL-36α (−50%, p=3.08×10⁻¹³), IL-36γ (−49%, p=4.35×10⁻⁸),
IL-31 (−68%, p=1.12×10⁻⁶), and IL-4 (−17%, p=2.87×10⁻⁵) compared to untreated controls,
as measured by quantitative Western blot analysis. These findings were associated with a statistically significant improvement in Investigator’s
Global Assessment (IGA) scores (mean 0.8 vs. 2.4; p=7.93×10⁻¹⁰), indicating reduced clinical signs of skin inflammation.
This may provide a potential new therapeutic class to compete in biologic-driven markets while avoiding the limitations inherent to biologic
therapy.

Tolerability Experience From Cleared
Medical Devices

Historical use of related
formulations in cleared medical device products provides background tolerability experience relevant to future development.

Intellectual Property Protecting
Core Technology and Product Candidates

We hold numerous issued patents
and multiple pending applications across major jurisdictions, covering composition, manufacturing methods, and delivery mechanisms. These
patents are expected to provide coverage for our lead product candidates into the late 2040s. Our intellectual property strategy includes
both product-specific and platform-level claims, supporting both internal development and potential licensing opportunities. For more
information, see “- Intellectual Property.”

Notwithstanding our numerous
issued patents and pending applications, we have been party to, and may in the future become involved in, proceedings in the United States
or in foreign jurisdictions challenging the validity, priority or other features of patentability of our patent rights or those of third
parties that conflict with our own. For example, we filed a derivation proceeding in 2017 before the U.S. Patent and Trademark Office
(“USPTO”) against Marc Selner, alleging that Selner improperly and without authorization filed a patent application for an
invention conceived by Bradley Burnam. The USPTO did not name Mr. Burnam sole inventor of Selner’s application or cancel Selner’s
patent application, as we requested, and the U.S. Court of Appeals for the Federal Circuit affirmed the USPTO’s decision. The derivation
proceeding was to determine the party that was first inventor of the claims of Selner’s application. As a result, Selner’s
application may contain claims similar in scope to certain issued patents and patent applications. However, we own multiple issued patents
for which Mr. Burnam is an inventor that cover the inventions at issue in the derivation proceeding (and related subject matter). Furthermore,
prior to its issuance, we intend to file for reexamination of the Selner patent application based upon its lack of enabling data, disclosures,
and expert testimony. Should the application ultimately issue as a patent, he may attempt to seek royalties or try to prevent our development
and commercialization of products he may allege overlap with his application claims or otherwise seek damages from us. For more information,
see “Risk Factors - Risk Related to Our Intellectual Property, Data Privacy and Cybersecurity.”

Capital-Efficient Operating Model
Designed for Scalable Growth

We operate with a lean infrastructure,
leveraging expert consultants and outsourced manufacturing to minimize fixed overhead and preserve capital for high-value activities.
Our pipeline strategy is informed by independent clinical observations, peer-reviewed publications, and identified gaps in the standard
of care. This model allows us to advance multiple assets in parallel while maintaining operational discipline.

Positioned to Capitalize on Market
Disruption and Patent Expirations

Several incumbent therapies
across dermatology and antifungal markets are nearing the end of their patent protection periods. We believe this shift creates an opportunity
to introduce differentiated, formulation-driven therapies into markets with stagnant innovation and increasing generic pressure. Our products
are designed to compete not just on efficacy, but also on tolerability, usability, and alignment with evolving patient and provider expectations.

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Our Growth Strategy

Our growth strategy is built around the following
key priorities:

1.
Advance GX-03 as
the primary development program for moderate-to-severe eczema. The eczema program is the central focus of ongoing clinical development,
regulatory planning, and potential partnering discussions.

2.
Develop GX-03 for onychomycosis as a
secondary dermatology indication.

3.
Maintain and expand
medical device partnerships. The recent license and supply agreement with Medline for K183681 reflects the company’s approach to
leveraging device assets through commercial partners.

4.
Continue exploratory work in thermostable
intranasal vaccines as a separate development lane.

Clinical Results

Previous in-vivo and in-vitro
work for GX-03, as well as GX-03 derived technology indicate a favorable tolerability profile, including a lack of cytotoxicity, irritation,
and/or sensitization, as well as a lack of systemic uptake.

These results culminated
in our previous FDA clearances for the GX-03 formula and its derivative products in 2016, 2017, and 2019 (K160872, K171191, and K183681,
respectively). These 510k FDA clearances were filed and cleared as FRO classification combination products and subject to performance
testing including ISO-10993 cytotoxicity, irritation, and sensitization studies. All studies were conducted in GLP and received passing
scores per ISO-10993 guidelines.

In support of our onychomycosis
development program, we conducted an in-vivo study titled “Efficacy In Vivo Onychomycosis (Trichophyton mentagrophytes) Study”
at Altogen Labs (Austin, Texas), under IACUC protocol LC03456, initiated in May 2019 and completed in June 2019. The study employed a
well-characterized rabbit onychomycosis model, using Trichophyton mentagrophytes to mimic clinically relevant fungal infections of the
nail, as described in a peer-reviewed protocol published in Antimicrobial Agents and Chemotherapy (2011). In the study, infected rabbits
were treated topically with our GX-03 formulation (0.5% PHMB in petrolatum) once daily for 30 days. Fungal burden was quantified using
qPCR on nail clippings, targeting T. mentagrophytes DNA. The treatment group showed a statistically significant reduction in fungal DNA
expression relative to untreated controls (p = 0.0005), with no adverse events or animal deaths observed. These findings demonstrate that
the GX-03 topical formulation was able to penetrate the nail plate and exert antifungal activity against organisms located in the deeper
layers of the nail - a capability not typically achieved by conventional topical therapies - and support further
development of the product for onychomycosis and related fungal skin conditions.

In June 2024, we completed
an in vivo efficacy study titled “In Vivo Staphylococcus aureus Dermal Toxicity Study” (Study R#XTN025486; protocol LC-04761)
at Altogen Labs in Austin, Texas, designed to evaluate the therapeutic potential of GX-03 in a mouse model of Staphylococcus aureus - induced
skin inflammation. The study utilized a published eczema induction protocol established by Liu et al. (Cell Host & Microbe, 2017)
and enrolled 30 mice randomized across three treatment arms. Following a 7-day course of GX-03 topical application, the treatment group
demonstrated a mean ISGA score of 1.44, compared to 3.00 in untreated controls, representing a 57% reduction in disease severity. No adverse
events or clinical signs of toxicity were observed. We believe these data support rapid skin-calming and anti-inflammatory effects of
GX-03 and may provide early validation for its use in inflammatory skin conditions such as eczema.

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In July 2024, we completed
a second in vivo study titled “In Vivo Pretreatment Staphylococcus aureus Dermal Toxicity Study” (Study R#XTN025491; protocol
LC-04785), also conducted at Altogen Labs, to assess the immunological impact of GX-03 in a cytokine-driven model of eczema. In this study,
40 C57BL/6 mice received a 4-day topical pretreatment with GX-03 prior to disease induction. Skin inflammation was evaluated by blinded
ISGA scoring and protein-level analysis of key inflammatory markers. Mice treated with GX-03 showed a mean ISGA score of 0.83, compared
to 2.44 in controls, with a highly significant p-value (p = 7.93 × 10⁻¹⁰). Western blot analysis of skin tissue
samples revealed suppression of eczema-related cytokines, including:

●
IL-31: 67.7% reduction (p = 1.12 ×
10-6)

●
IL-36α: 50% reduction (p = 3.08
× 10-13)

●
IL-36γ: 49% reduction (p = 4.35
× 10-8)

●
IL-4: 17% reduction (p = 2.87 ×
10-5)

No adverse reactions or health
concerns were noted throughout the study. Together, these findings demonstrate that GX-03 is capable of downregulating multiple upstream
inflammatory cytokines associated with atopic dermatitis in animal model.

We are currently conducting
a randomized, double-blind, vehicle-controlled clinical trial to evaluate the tolerability and effectiveness of topical investigational
product, GX-03, in adult subjects with moderate-to-severe eczema. The study is titled: “A Double-Blind, Vehicle-Controlled Study
to Assess the Efficacy of GX-03 When Used in a Population of Adult Individuals with Moderate to Severe Eczema”, and is classified
as a Phase 2 trial.

The study is being conducted
at a Center of Excellence in Franklin, Texas, operated by Australia Laboratory Sciences (ALS), a multinational contract research organization.
The study investigators are Barry Reece, MS, Dr. Max Adler, and Dr. Gene Ream.

The study is designed to
enroll 114 to 120 adult subjects aged 18 to 70, with a target of at least 100 subjects completing the full protocol. Participants
are randomized to receive either GX-03 or a matched vehicle control, applied topically in blinded form. The primary objective is to evaluate
clinical improvement in eczema relative to baseline and vehicle control.

An interim assessment will
be performed at approximately 50% trial completion. An independent interim assessment committee (“IAC”) will review emerging
signals of tolerability and efficacy. The IAC is empowered to deliver pre-written statements regarding conditional probability of a statistically
significant favorable trial outcome, as well as increase the sample size up to 200% if the committee sees a strong likelihood of achieving
statistical significance based upon positive trending. This adaptive trial design, due to the independence of the committee, pre-established
rights, and pre-written statements the committee is permitted to deliver after deliberating, does not increase the likelihood of primary
error and/or expend alpha.

The primary endpoint is the
change in Eczema Area and Severity Index (EASI) scores from baseline to weeks 4 and 8. Secondary endpoints include changes in Validated
Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) and Peak Pruritus Numeric Rating Scale (PP-NRS) scores over the
same period. Tolerability and effectiveness are assessed throughout the study by monitoring treatment-emergent adverse events and evaluating
potential causal associations with the study drug.

This trial is designed to
generate controlled data on the potential clinical utility of GX-03 in treating inflammatory skin disease, particularly in non-steroidal
management of moderate-to-severe atopic dermatitis. We intend to include these findings in our investigational new drug application package.
Additionally, we expect findings from this study to inform the broader development strategy and potential regulatory submissions for GX-03.

Onychomycosis (Fungal Nail Infection)

Turn is pursuing indications
for GX-03 as a topical PHMB-based formulation for onychomycosis. The company has identified the mechanism of action via in-vivo data demonstrating
nail plate penetration and antifungal activity within the nail. This ability to effectively penetrate the keratin clinically differentiates
this candidate from other topicals on the market, which studies have shown lack effective nail penetration capabilities.

Clinical Products

K183681

K183681 represents the first
antimicrobial version of Adaptic®-style non-adherent wound dressings, incorporating liquid antimicrobials to provide both moisture
retention and antimicrobial protection in wound dressing changes and post-surgical management. K183681 is FDA cleared to include these
antimicrobial claims in both name and indications, and we have licensed this product to Medline.

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K171191

Turn has received FDA clearance
for the GX-03 formula as a medical device indicated to manage the symptoms of atopic, radiation, and irritant dermatitis. Sampling for
human use under this labeling confirmed patient and clinician satisfaction. Mechanism of action studies later confirmed meaningful reductions
in inflammatory cytokines without the use of systemic biologics, including IL-4, IL-31, and IL-36 variants, which are implicated in eczema
pathogenesis. These findings are complemented by reductions in Investigator’s Global Assessment (IGA) scores in animal models of
atopic dermatitis. GX-03/K171191 operates through multiple mechanisms of action: direct antimicrobial activity of excess inflammatory
staph aureus common in eczema patients’ skin, buildup of the fractured skin mantle facilitated said excess staph aureus colonization,
as well as modulation of inflammatory pathways that lead to the symptoms of eczema. The product is currently being studied under this
labeling in a double-blind RCT for its safety and effectiveness in moderate-severe eczema patients. Leveraging this data, its previous
FDA clearance in atopic dermatitis management, and other clinical and preclinical data, the company intends to move from this RCT to IND
submission under which Phase 3’s and any additional human testing would be conducted prior to a potential new drug approval submission.
We have not currently out-licensed this product but are actively identifying potential partners for distribution outside the United States.

K160872

K160872 is an FDA cleared
medical device indicated for acute and chronic wound management that has been used on thousands of patients to accelerate healing of advanced
wounds, including traumatic and diabetic wounds. It has been proven to cause no damage to healthy cells while offering broad antibacterial,
antifungal, and anti-yeast activity. K160872’s petrolatum base does not macerate wounds and can be left in place for days between
dressing changes. The formula has been the subject of many publications, including peer-reviewed publications such as “A Novel Approach
to the Treatment of Necrotizing Fasciitis” in Acta Scientific Orthopaedics in 2023. We have not out-licensed this product.

Marketing

We strategically license
and commercialize our medical device technologies through commercial partners while we concentrate on the research, development and regulatory
advancement of new drug indications, a model intended to provide financing flexibility to the company via passive revenue streams.

MiMedx Agreement

In November 2022, we entered
into the MiMedx Agreement wherein we granted MiMedx an exclusive, sublicensable license under certain of our intellectual property, technology
and biomaterials, including as related to the FleX Product, to develop, manufacture and commercialize (i) the FleX Product in the Territory
and (ii) certain other biological products worldwide, in each case, in the wound care, burn care and surgical care fields only. We also
granted MiMedx certain exclusive and non-exclusive licenses under specified trademarks. We retain exclusive development and commercialization
rights for the FleX Product outside the Territory with MiMedx having the right of first refusal to acquire, subject to certain procedures,
exclusive development, manufacturing and commercialization rights. We are responsible for overseeing, monitoring and coordinating all
regulatory actions, communications and filings with, and submissions to the FDA with respect to initial marketing approval.

We received a $1.0 million
milestone payment upon the execution of the MiMedx Agreement and payments totaling $450.0 thousand as part of the letter of intent entered
into with MiMedx in February 2022, as amended.

In the event development
and commercialization of the FleX Product in the Territory is successful, we are eligible to receive milestone payments of up to $69.55
million specifically related to the development and commercialization of the FleX Product. However, if the FleX Product is not launched
within four months after receiving FDA marketing approval or the execution of the supply agreement for the FleX Product, then, provided
the delay is not caused by us, MiMedx must also pay us monthly payments in the low hundreds of thousands of dollars, to be deducted from
a specified milestone. In addition, we are entitled to receive milestone payments of $1.0 million for each additional product developed
and commercialized under the agreement.

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Subject to the terms and
conditions of the MiMedx Agreement, MiMedx is required to pay a mid-single digit royalty of net sales on a quarterly basis. The MiMedx
Agreement includes certain adjustments for third party royalties. If MiMedx reasonably believes it must obtain or maintain a third-party
license to manufacture or commercialize the FleX Product or another licensed product in a territory, it may generally credit up to 50%
of the total royalty payments it must pay the third-party licensee against royalties payable to us. We are eligible to receive royalty
payments on a country by country basis for each product commercialized under the agreement, for a period beginning upon the first commercial
sale of the product and expiring ten years after launch of the product. We have determined that we have one combined performance obligation
remaining under the MiMedx Agreement related to the development and commercialization of the FleX Product in the Territory, which primarily
includes knowledge and bio-materials transfer to MiMedx, assisting and coordinating the regulatory approvals with the FDA and ongoing
access and upkeep of intellectual property during the term of the MiMedx Agreement and related development and regulatory services. Development
and commercialization milestones were not considered probable at inception and therefore were excluded from the initial transaction price.
The royalties were excluded from the initial transaction price because they relate to a license of intellectual property and are subject
to the royalty constraint.

The term of the MiMedx Agreement
runs until the last date on which any licensed product is covered by a valid claim of any of the licensed patents, the earliest of which
is currently expected to expire in 2044. Following the expiration of the term of the MiMedx Agreement, the licenses granted become fully
paid-up and perpetual, but to the extent MiMedx continues to commercialize the FleX Product after the expiration of the term of the MiMedx
Agreement, and such commercialization requires use of our trade secrets, MiMedx must continue to pay us a reduced royalty for a period
expiring 10 years after the launch of the FleX Product.

The agreement allows for
termination under specific circumstances. Either party may terminate the agreement if the other party materially breaches the agreement
and fails to cure the breach within 90 days of receiving written notice, or if the other party becomes bankrupt or insolvent. MiMedx also
has the right to terminate (i) the agreement in its sole discretion with three months’ prior written notice and (ii) the license
to the FleX Product at any time. We retain the right to terminate the agreement if MiMedx fails to launch the FleX Product in the United
States within 10 months of receiving FDA marketing approval or executing the supply agreement for the FleX Product, whichever is later,
provided the delay is not caused by us.

Medline Agreement

On October 27, 2025, we entered
into the Medline Agreement with Medline, the world’s largest manufacturer and distributor of medical-surgical products. Pursuant
to the Medline Agreement, we will collaborate with Medline to develop, manufacture, and commercialize professional and consumer health
products that leverage our proprietary PermaFusion® delivery platform. Medline will lead global commercialization and distribution
across its professional and retail networks in more than one hundred countries and territories, while we will contribute formulation expertise,
intellectual property, and clinical development capabilities. The Medline Agreement establishes a multi-year framework for supply and
co-development activities, including manufacturing scale-up for our PermaFusion-based formulations and the co-branding of future products
in the professional and retail space(s).

Sales Process

For medical device products
and indications, we intend to partner with existing organizations with established sales forces and commercial channels. We intend to
serve as an educational and sales resource as well as a contract manufacturer given our established production chain. We intend to seek
partners for drug programs during the approval process timeline, but we will prepare to commercialize if management deems it a superior
choice for the company.

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Our Market

Eczema / Atopic Dermatitis: Market
Overview and Unmet Needs

Atopic dermatitis, commonly
referred to as eczema, is a chronic inflammatory skin condition characterized by pruritus (itching), erythema (redness), and skin barrier
dysfunction. According to the National Eczema Association, it is one of the most prevalent skin disorders globally, affecting an estimated
10-20% of children and up to 10% of adults in developed countries. In the United States, approximately 16.5 million adults are impacted
by eczema, with moderate-to-severe eczema accounting for 40% of these patients.

According to Fact MR, the
global market for the treatment of atopic dermatitis, commonly known as eczema, is estimated at approximately $12.0 to $18.0 billion.
The market is expected to expand, largely driven by rising awareness of eczema, quick detection and rising use of harsh sanitary products.
Moderate-to-severe cases represent an estimated 40% of the total market. According to the National Eczema Association, it is estimated
that 6.6 million adults and 3.2 million children in the United States have moderate-to-severe eczema. Dupixent® (dupilumab), an injectable
biologic, currently leads the market in sales and revenue. Despite its success, Dupixent’s injectable format remains a barrier for
certain patient populations, particularly pediatric patients, underscoring demand for noninvasive, effective alternatives.

Current treatment paradigms
for atopic dermatitis include topical corticosteroids, calcineurin inhibitors, systemic immunosuppressants, and more recently, biologic
therapies targeting specific cytokines involved in disease pathogenesis. While biologics such as Dupixent® (dupilumab) have demonstrated
efficacy in moderate-to-severe cases, they are associated with high costs, require systemic administration, and may present risks of immune
modulation. Additionally, topical corticosteroids are limited by concerns over long-term skin thinning, irritation, and sensitization.
While newer biological topicals, such as JAK inhibitors like Vtama®, have demonstrated some efficacy in moderate-severe eczema, they
are hindered by high cost and poor safety profiles that often lead to so-called “black-box” warnings.

There remains unmet need
for effective, non-steroidal, non-systemic topical therapies that can address both microbial burden and inflammatory pathways without
the adverse effects commonly associated with existing treatments. Turn Therapeutics has initiated human trials for GX-03 as a topical,
non-steroidal, non-biologic immunotherapy for moderate-severe eczema, leveraging its dual mechanism of action: direct antimicrobial activity
and inhibition of pro-inflammatory cytokines implicated in atopic dermatitis. Data and FDA clearances indicate the formula is non-cytotoxic,
non-irritating, and non-sensitizing, which we believe will help address key tolerability concerns as compared to current therapies.

Nail Fungus / Onychomycosis: Market
Overview and Unmet Needs

Onychomycosis is a common
fungal infection of the nails, primarily caused by dermatophytes, yeasts, and non-dermatophyte molds. The condition results in nail discoloration,
thickening, and separation from the nail bed, leading to pain, discomfort, and cosmetic concerns. According to CDC, onychomycosis is estimated
to effect approximately 14% of the U.S. and global population, with prevalence increasing in older adults and individuals with comorbidities
such as diabetes or peripheral vascular disease. Most patients with onychomycosis do not seek professional treatment due to the limitations
of current therapeutic options, detailed below.

According to Grand View Research,
the global market for the treatment of onychomycosis (fungal nail infections) was valued at approximately $3.81 billion in 2024, with
North America representing 40.3% of the global market in 2024. Despite the high prevalence of onychomycosis, a majority of affected individuals
do not seek treatment. This is largely due to factors such as lack of awareness, the need for confirmed diagnosis through nail samples,
and expensive treatments often not covered by insurance. Topical antifungals have demonstrated limited efficacy, with success rates ranging
from 6.5% to 17.9%; CDC only suggests oral therapies for onychomycosis based on limited efficacy of topicals, yet oral terbinafine (LAMISIL®),
the oral/primary systemic alternative, is associated with hepatotoxicity risks and typically requires ongoing liver function monitoring.
The market presents substantial opportunity for novel, safe, and efficacious topical therapies. Current treatment options include oral
antifungal medications (e.g., terbinafine, itraconazole) and topical therapies (e.g., ciclopirox, efinaconazole). Oral therapies demonstrate
higher efficacy but are associated with systemic side effects, including hepatotoxicity and drug-drug interactions, limiting their use
in certain patient populations. Treatment durations are long, often requiring 12 weeks or more, and recurrence rates remain high.

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Topical therapies offer a
safer route of administration but are limited by poor nail penetration and suboptimal efficacy. Clinical cure rates for topicals are typically
below 20%, with efinaconazole (Jublia®), one of the leading products, demonstrating complete cure rates of approximately 15-18% in
pivotal trials. These limitations underscore the need for novel topical treatments capable of effectively penetrating the nail plate and
delivering therapeutic concentrations to the site of infection without systemic exposure.

Turn Therapeutics is advancing
GX-03 as a topical formulation for onychomycosis, designed to overcome nail penetration challenges while leveraging its established antimicrobial
properties. In-vivo data support the formulation’s ability to reach the nail bed and exhibit fungicidal activity against dermatophytes,
addressing key shortcomings of current topical therapies. Additionally, data from a 100 plus patient, independent investigation entitled
“A Novel Approach to Polymicrobial Nail Infection” conducted by R. Daniel Davis, DPM in 2018-2019, suggests that Turn’s
formulation may achieve clinical clearance (based on visible evidence of the development of a Beau’s line with progression of a
clear nail plate to the distal end of the nail) as high as 70-85% in diverse patient populations (including diabetic patients) when applied
topically once or twice daily. This data suggests favorable outcomes among patients beyond Turn’s in-vivo models as conducted by
Altogen Laboratories. Data generated by any independent investigators may not predict the results of later clinical trials of any of our
current or future product candidates. “A Novel Approach to Polymicrobial Nail Infection” involved no placebo or comparator
group, and was an investigator-initiated trial, meaning that Turn has less control over the protocols, administration or conduct of the
trial as compared to its own trials, including follow-up with patients and ongoing collection of data after treatment.

Advanced Wound Care and Vaccines

According to Market Research
Future, the global advanced wound care market was estimated at approximately $18.72 billion in 2024 and is projected to grow to $30.76
billion by 2034, reflecting a compound annual growth rate (“CAGR”) of 5.09% over the forecast period. Advanced wound care
products are essential for treating chronic wounds such as diabetic foot ulcers, pressure ulcers, and burns. However, current offerings
are frequently limited by short duration of action, wound cytotoxicity, and vulnerability to microbial colonization. The advanced wound
care market encompasses a diverse range of solutions, including negative pressure wound therapy, advanced dressings, tissue engineered
skin substitutes, wound cleansers and irrigants, and wound closure devices. Significant revenue growth is occurring across various regions,
with North America demonstrating the highest expected growth rate, with revenue valued at $7.2 billion in 2023 and projected to reach
approximately $11.0 billion by 2032. Effective products that minimize risk and maximize healing rate while reducing the rate of microbial
infiltration to the wound/ dressing(s) would meet significant unmet needs in this space.

Vaccines represent a crucial
market segment. However, challenges such as cold-chain logistics and limited thermostability have historically hindered vaccine access
for patients, who must seek out caregivers to deliver highly unstable vaccines via injection. Innovations in thermostable, intranasal
vaccines can address these issues, opening significant opportunities to improve global immunization coverage and penetrate untapped markets.
A study conducted by University of Liverpool shows that the introduction of a mobile vaccination unit has the potential of increasing
the number of first-time vaccinations among patients by 25%, which we believe suggests that the more convenient nature of a thermostable,
intranasal vaccine could result in significant growth in vaccine uptake. Furthermore, leading players have engaged in mergers and acquisitions
for strategic reasons such as expanding their product line and market potential.

We anticipate the primary
market for an initial influenza vaccine candidate will consist of governmental and military agencies seeking to stockpile vaccines, as
well as public health organizations aiming to distribute the vaccine without need for cold chain logistics. We also anticipate increased
uptake of needle-free vaccines that can be administered in clinics or homes. Subject to successful clinical development and regulatory
approval, we believe our initial vaccine candidate could be eligible for multi-year procurement contracts from government agencies including
BARDA and the Department of Defense, as well as international public health stakeholders such as the WHO and CEPI. The current global
market for influenza vaccines was assessed at $8.49 billion in 2024 and is projected to reach $16.73 billion by 2034, growing at a CAGR
of 7.02% for the forecasted period.

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Our Competition

The biopharmaceutical industry
utilizes rapidly advancing technologies and is characterized by intense competition. There is also a strong emphasis on intellectual property
and proprietary products. In our segment of the biopharmaceutical industry, competition from different sources including major biopharmaceutical
companies, academic institutions, government agencies and public and private research institutions will continue. Many of our competitors
have significantly greater financial resources and expertise in product candidate development and may have progressed further toward approval
and marketing. In addition, smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large and established companies.

Regulatory Environment

We are subject to extensive
federal, state and local government regulation, including those relating to public health and safety, labeling and disclosure requirements
and drug and device safety regulations. Failure to obtain or retain necessary licenses, registrations, clearances, approvals or exemptions
could adversely affect the operation of our business. We are also subject to federal and state labor and employment laws, including the
Fair Labor Standards Act, the Immigration Reform and Control Act of 1986, and the Americans with Disabilities Act, among others, which
regulate matters such as minimum wage, overtime, employment tax rates, workers’ compensation, citizenship requirements and workplace
accommodations.

In the United States, the
FDA regulates the safety of food, drugs, medical devices, and cosmetics under the Federal Food, Drug, and Cosmetic Act (the “FDCA”)
and the Public Health Services Act and implements related regulations. Failure to comply with applicable FDA requirements can result in
a range of penalties, from warnings and product recalls to significant fines and even criminal prosecution. The products in our portfolio
and pipeline require either FDA clearance as a medical device or FDA approval as a drug or biologic. The FDA regulatory process varies
depending on whether a product is classified as a medical device or pharmaceutical (drug) and biologic, as discussed below.

Drugs and Biologics

The FDA extensively regulates
pharmaceutical products in the United States. Pharmaceutical drugs and biologics undergo a rigorous NDA or BLA process, which includes
multiple stages:

●
Preclinical Testing - Completion
of laboratory and animal studies assess the safety and efficacy of the product before human trials in accordance with applicable regulations
such as the FDA’s Good Laboratory Practice Regulations.

●
IND Application - The
company must submit an IND to the FDA, detailing results of pre-IND data and proposed additional studies intended to be used for new drug
approval, such as phase 3 studies. The IND must become effective before beginning human clinical trials as an investigational drug candidate.

●
Clinical Trials - Conducting
adequate and well-controlled human clinical trials according to IND and good clinical practice regulations. Trials are conducted in three
phases unless specified by the agency in meetings/interactions; these phases may overlap or be combined:

●
Phase 1: The product
is initially introduced into a small number of healthy human subjects or patients and tested for safety, dosage tolerance, absorption,
metabolism, distribution and excretion and, if possible, to gain early evidence on effectiveness. In the case of some products for severe
or life-threatening diseases, especially when the product is suspected or known to be unavoidably toxic, the initial human testing may
be conducted in patients.

●
Phase 2: Involves
clinical trials in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy
of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage and schedule.

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●
Phase 3: Clinical
trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed
clinical trial sites. These clinical trials are intended to establish the overall risk/benefit relationship of the product and provide
an adequate basis for product labeling.

●
NDA or BLA - Following successful
clinical trials, a formal application is submitted for FDA approval.

●
Pre-Approval Inspection - Successful
completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the product is, or will be, produced. This
inspection verifies that the facilities, methods, and controls used in the production of the drug are in compliance with the FDA’s
cGMP regulations.

●
Clinical Trial
Site Audit - Potential audits of the clinical trial sites that generated the data supporting the NDA or BLA, which help ensure
the accuracy and reliability of the data used to evaluate the safety and effectiveness of the drug.

●
NDLA/BLA Review
and Approval - Prior to commercial marketing and sale, the FDA will review the NDA or BLA submitted by the drug manufacturer.
If the application meets all the necessary requirements and the FDA deems the drug safe and effective, it will approve the application.

There is no assurance that
the FDA will ultimately approve a product for marketing in the United States, and we may encounter significant difficulties or costs during
the review process. If a product receives marketing approval, the approval may be significantly limited to specific diseases and dosages
or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require
that certain contraindications, warnings or precautions be included in the product labeling or may condition the approval of the NDA or
BLA on other changes to the proposed labeling, development of adequate controls and specifications, or a commitment to conduct post-market
testing or clinical trials and surveillance to monitor the effects of approved products.

Our Drug Programs

●
Eczema and Onychomycosis
Program: Assuming success of the clinical programs, these submissions will be NDAs incorporating a new chemical entity (NCE) as its active
ingredient (polyhexanide).

●
Thermostable Vaccine
Program: We expect to submit this vaccine candidate following successful IND filing, Phase 1 and Phase 2 clinical trials as a drug product
under an NDA or a BLA. The regulatory pathway will be determined based on classification as a drug or biologic.

Medical Devices

Medical devices are tools,
machines, implants, or instruments used to diagnose or manage medical conditions without altering the body’s chemical structure.
The FDA regulates medical devices under the FDCA and classifies them into three categories based on their risk profile:

●
Class I and II
devices typically require pre-market notification through the 510(k) process, demonstrating that the device is substantially equivalent
to an already legally marketed device. Our existing medical device clearances were obtained via the 510(k) process.

●
Class III devices
and novel devices that lack a predicate device may require De Novo classification or a pre-market Approval (“PMA”), which
involves more extensive clinical testing and a comprehensive review of safety and efficacy. Our partner has elected to pursue De Novo
classification for the FleX Product, which requires more testing.

As discussed above, authorization
to commercially distribute a new medical device in the United States can be obtained via either (i) pre-market notification (also known
as the 510(k) process), (ii) De Novo classification and (iii) PMA, depending on the specific classification determined by the FDA.

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Wound dressings, such as the
ones for which we previously received FDA clearance, including those under device classification FRO, have historically been designated
as unclassified devices. These legacy devices were first marketed prior to the Medical Device Amendments of 1976 and, while cleared for
use, have not been formally classified into Class I, II or III. The licensor elected to pursue clearance of the FleX Product through the
De Novo classification process, as it may represent a novel device without a direct predicate. Because the FleX Product is derived from
biologically sourced collagen and may incorporate features such as enhanced healing support or bioresorbability, we anticipate the FDA
will classify it as a Class II medical device, subject to special controls. This expectation aligns with prior FDA treatment of collagen-based
wound dressings submitted through De Novo or 510(k) pathways, particularly under product code KGN, which is now commonly associated with
Class II classification.

During a pre-submission meeting
with FDA attended by MiMedx and us, we indicated our desire to submit the FleX Product as a 510(k) under the FRO product code in order
to obtain antimicrobial claims available to products in said device category. We presented proposed predicate products to suit the FRO
category in a 510(k) submission. At the meeting, FDA suggested that the novelty of the product may lend itself better to a De Novo submission.
While the product is physically similar to KGN collagen powders in primary produced form, KGN is not an antimicrobial category. Therefore,
while the product could likely achieve KGN indications under 510(k) via removal of specific antimicrobial claims, those claims were stated
as desired by our partner. Therefore, the agency recommended the De Novo category, as well as suggested additional antimicrobial tests
that included three validated production lots aged in real time (one to two years) tested before and after aging for antimicrobial activity.
The agency also suggested a human factor test to include potential users mixing the product as would be intended in the directions for
use (premixing with saline) which would verify the capability to consistently mix across the users. MiMedx elected to assume control of
the data production and submission. De Novo clearances vary in review time. After any De Novo request is accepted, the FDA will conduct
a substantive review to determine if the device meets the criteria for De Novo classification. There can be no assurance as to the FDA’s
final determination.

Post-Marketing Requirements

Following FDA approval or
clearance, we are subject to a comprehensive set of post-marketing surveillance and regulatory compliance obligations intended to ensure
continued safety, efficacy, and regulatory adherence throughout the commercial life of the product, which includes:

●
Adverse event reporting
and post-market safety monitoring. We will be required to monitor and report adverse events and product complaints to the FDA in accordance
with applicable regulations. This includes submission of Medical Device Reports (MDRs) for devices and Adverse Event Reports or Field
Alert Reports (FARs) for drugs and biologics.

●
Post-market studies
(if required by the FDA for additional safety or efficacy data). Post-approval trials (also referred to as Phase 4 clinical trials) may
be conducted after a drug or device has received regulatory approval and is commercially available. These trials focus on monitoring the
long-term safety, effectiveness, and potential risks of the drug in a broader, real-world patient population.

●
Compliance with
cGMP for drugs and Quality System Regulations (“QSR”) for medical devices. We will be expected to maintain full compliance
with cGMP for drugs and biologics and QSR for medical devices. These frameworks govern all aspects of manufacturing, testing, labeling,
packaging, storage and distribution to ensure consistent product quality and prevent contamination, mislabeling or product failure. The
FDA regularly inspects manufacturing and quality control facilities to verify compliance, and significant violations may result in warning
letters, fines, import alerts or shutdowns.

●
Marketing and advertising
regulations to ensure promotional materials do not mislead consumers or misrepresent safety and effectiveness. Our promotional activities,
including advertising, product labeling, websites, and educational materials, will be subject to FDA regulation and oversight to ensure
they are not false, misleading, or unsubstantiated. All claims regarding a product’s safety, effectiveness, or performance must
be consistent with the product’s approved labeling.

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Failure to fully comply with
post-marketing requirements can result in a range of enforcement actions by the FDA or other regulatory agencies. These actions may include
the issuance of Form 483 inspectional observations, warning or untitled letters, civil monetary penalties, seizure of products, injunctions,
product recalls or withdrawal of product approval or clearance.

Intellectual Property

Our success depends in part
upon our ability to protect our intellectual property. To protect our intellectual property rights, we primarily rely on patents and trade
secret laws, confidentiality procedures, and invention assignment language binding on our employees. Our intellectual property is critical
to our business and we strive to protect it through a variety of approaches, including by obtaining and maintaining patent protection
in various countries for our products, product candidates and other inventions that are important to our business.

Patents

Our patents cover, among
other things, our methods of mixing, chemical compositions, and uses of such compositions. The patent positions of companies like ours
are generally uncertain and involve complex legal and factual questions. Changes in the patent laws and rules, either by legislation,
judicial decisions, or regulatory interpretation in other countries may diminish our ability to protect our inventions and enforce our
intellectual property rights, and more generally could affect the value of our intellectual property. In particular, our ability to stop
third parties from making, using, selling, offering to sell, importing or otherwise commercializing any of our patented inventions, either
directly or indirectly, will depend in part on our success in obtaining, defending and enforcing patent claims that cover our technology,
inventions and improvements. We cannot be sure that any patents will be granted with respect to any of our pending patent applications
or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents
that may be granted to us in the future will be commercially useful in protecting our products and product candidates and the methods
used to manufacture them. Moreover, our issued patents and those that may issue in the future may not guarantee us the right to practice
our technology in relation to the commercialization of our products. The area of patent and other intellectual property rights in the
biotechnology and pharmaceutical industries is an evolving one with many risks and uncertainties which may prevent us from commercializing
our products or product candidates.

Our issued and future potential
patents may be challenged, narrowed, circumvented or invalidated, which could limit our ability to stop competitors from marketing related
platforms or product candidates or limit the length of the term of patent protection that we may have for our products of product candidates.
In addition, the rights granted under any issued patents may not provide us with complete protection or competitive advantages against
competitors with similar technology. Furthermore, our competitors may independently develop similar technologies that achieve similar
outcomes but with different approaches. For these reasons, we may have competition for our products and product candidates. Moreover,
the time required for development, testing and regulatory review of our products and product candidates may shorten the length of effective
patent protection following commercialization.

The term of individual patents
depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we file, the patent
term is 20 years from the earliest date of filing of a non-provisional patent application. In the United States, the patent term of a
patent that covers an FDA-approved drug or biologic may also be eligible for patent term extension, which permits patent term restoration
as compensation for the patent term lost during FDA regulatory review process. The Hatch-Waxman Act permits a patent term extension of
up to five years beyond the expiration of the patent. The length of the patent term extension is related to the length of time the drug
or biologic is under regulatory review. Patent term extension cannot extend the remaining term of a patent beyond a total of 14 years
from the date of product approval, only one patent applicable to an approved drug or biologic may be extended and only those claims covering
the approved drug or biologic, a method for using it, or a method for manufacturing it may be extended. Similar provisions are available
in Europe and other foreign jurisdictions to extend the term of a patent that covers an approved drug or biologic. In the future, if our
products or product candidates receive FDA approval, we expect to apply for patent term extensions where applicable on patents covering
those products. We plan to seek patent term extensions to any of our issued patents in any jurisdiction where these are available, however
there is no guarantee that the applicable authorities, including the USPTO in the United States, will agree with our assessment of whether
these extensions should be granted, and if granted, the length of these extensions.

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Our Patent Portfolio

As of December 31, 2025,
we own 14 issued U.S. patents, five pending U.S. non-provisional patent applications, two issued foreign patents, in the E.U. and Japan,
five pending foreign patent applications, in the E.U. and Canada, and two pending Patent Cooperation Treaty applications. These patents
and patent applications cover, among other things, oil-based compositions that incorporate the PermaFusion process (including Hexagen),
as well as compositions and methods for the treatment of inflammatory skin disease, eczema, and onychomycosis. These patents and patent
applications (including any patent applications that we timely file based on our pending provisional patent applications), if issued,
are expected to expire between 2036 and 2045, in each case assuming payment of all appropriate maintenance, renewal, annuity or other
governmental fees.

Trademarks, Trade Secrets and Other Proprietary Information

We also have several registered
trademarks for ATOPX, CurX, PermaFusion and Turn Therapeutics. In addition, we have various proprietary mixing processes and compositions
maintained as trade secrets. We take steps to protect our proprietary information and trade secrets, including through contractual means
with our employees, advisors and consultants. We also take other appropriate precautions, such as physical and technological security
measures, to guard against misappropriation of our proprietary technology by third parties. In addition, the agreements we enter into
with our employees provide that all inventions conceived of by the individual during the course of employment, and which relate to or
are reasonably capable or being used in our current or planned business or research and development are our exclusive property.

There can be no assurance,
however, that these agreements will not be breached, or that these agreements, measures, and policies will provide meaningful protection
of our trade secrets or adequate remedies, including for our trade secrets, in the event of unauthorized use or disclosure of such information.
In addition, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain
access to our trade secrets or disclose our technology. As a result, we may not be able to meaningfully protect our trade secrets.

For more information regarding
the risks related to our intellectual property, see “Risk Factors - Risks Related to Our Intellectual Property, Data
Privacy and Cybersecurity.”

Manufacturing and Supply

We currently utilize a U.S.-based,
FDA-compliant CMO for the final manufacture and packaging of our GX-03 formulation, including our proprietary PermaFusion mixing process
and final drug product fill/finish. The selected CMO has extensive experience producing FDA-regulated drug products and has successfully
implemented our validated formulation protocols, including release testing, batch-to-batch consistency verification, and stability assessments.

All analytical methods used
in the manufacturing process, including assays to quantify the active biocide and other release criteria, have been validated and applied
across multiple lots. Stability studies, both real-time and accelerated, have been conducted. As of the date of this filing, we have completed
up to five years of real-time stability testing and two years of accelerated stability studies.

The manufacturing site has
previously produced drug and device products and is fully compliant with current cGMP. In addition, Turn has identified and conduct test
batches with a secondary manufacturing site in the United States to support risk mitigation and ensure uninterrupted product supply. In
the event of a disruption at the primary site, raw material procurement and validation at the secondary site is estimated to take approximately
six weeks, with an additional four weeks required to complete three validation batches.

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We operate under ISO 13485-compliant
quality systems, ensuring alignment with international standards for both medical device and combination product manufacturing. All raw
materials are sourced and validated by our CMOs, and in-process testing is performed in accordance with validated protocols to ensure
product consistency and safety.

Turn retains full ownership
of the proprietary PermaFusion mixing process at all manufacturing sites. This proprietary know-how is protected via confidentiality and
quality agreements executed with each site, ensuring that our intellectual property and trade secrets remain secure.

For medical device applications
of GX-03, including GX-03 impregnated gauze, we utilize in-house sterilization services provided by SCAPA via gamma irradiation (GAMMA).
This sterilization process has been validated and reviewed by the FDA.

All manufacturing, packaging,
and sterilization for Turn’s GX-03 based products is currently performed in the United States.

Employees

We currently have two full
time employees, with various contractors serving in manufacturing, regulatory, IT, accounting, quality and laboratory/clinical testing
functions.

Property

We lease 1,788 square feet
of office space in Westlake, California, the term of which extends through August 2027. We pay approximately $4.1 thousand per month.

Legal Proceedings

We are involved in legal
proceedings from time to time in the ordinary course of our business. Based on information currently available and established reserves,
we have no reason to believe that the ultimate resolution of any known legal proceeding will have a material adverse effect on our financial
position, liquidity or results of operations. However, there can be no assurance that the outcome of any such legal proceeding will be
favorable, and adverse results in certain of these legal proceedings could have a material adverse effect on our financial position or
results of operations. See “Risk Factors - Risks Related to Our Intellectual Property, Data Privacy and Cybersecurity - If
we are unable to obtain, maintain and enforce patent protection for our current products and product candidates, and any future products
or product candidates we may develop, or if the scope of the patent protection obtained is not sufficiently broad, our competitors or
other third parties could develop and commercialize products and product candidates similar or identical to ours and our ability to successfully
develop and commercialize our products and product candidates may be adversely affected.”

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