OTC: INTI

We
have also engaged Avior Bio, Inc. (“Avior”) to develop a proprietary micronized/amorphous itraconazole formulation intended
to support our BCCNS program. Formulation development has been completed, and we are pursuing pharmacokinetic work designed to compare
the Avior formulation to previously studied itraconazole formulations used in clinical settings. We believe this formulation strategy
may support a differentiated chemistry, manufacturing and controls package, may improve bioavailability and plasma consistency, and may
enhance the economic durability of the program if paired with new patent protection and orphan-drug exclusivity.

As
part of our development activities, we also maintain relationships with patient advocacy groups and incorporate insights from these interactions
into our development strategy.

Selected
Program Metrics

Metric

Current
Program Disclosure

Lead indication

Basal cell carcinoma
nevus syndrome (“BCCNS” / Gorlin Syndrome)

Clinical study

HP2001 Phase IIb;
38 patients; 477 surgically eligible baseline lesions

Key efficacy metric
reported to FDA

Per-lesion objective
response rate of 57.7%

Patient-level disease
control reported to FDA

97.4%

Regulatory status

Type C meeting granted;
written responses expected May 2026

Formulation status

Proprietary Avior micronized/amorphous
formulation developed; PK work in progress

Disease
Background and Unmet Need

BCCNS
is a rare hereditary cancer predisposition syndrome characterized by the continuous development of basal cell carcinomas over a patient’s
lifetime. The syndrome has been described as affecting approximately 1 in 30,000 to 1 in 31,000 individuals (Bree & Shah, 2011; National
Organization for Rare Disorders), and our current internal estimates assume a U.S. patient population of approximately 11,000 based on
these prevalence rates and U.S. Census data. Patients often begin developing tumors at a relatively young age, and the disease course
is chronic rather than episodic (Kimonis et al., 1997).

The
burden of BCCNS is not limited to the number of tumors. In the Gorlin Syndrome Alliance Voice of the Patient report submitted to the
U.S. Food and Drug Administration, patients described having dozens to more than one thousand basal cell carcinomas removed over the
course of their lives, with some individuals undergoing a substantial number of surgical interventions (Gorlin Syndrome Alliance, 2018).
Patients and caregivers describe the disease as physically painful, psychologically burdensome and progressively disfiguring. We believe
these characteristics distinguish BCCNS from more typical presentations of basal cell carcinoma and support the view of the disease as
a chronic condition requiring ongoing management.

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Selected
References

● Bree
AF, Shah MR. Consensus statement from the first international colloquium on basal cell nevus
syndrome (BCCNS). Am J Med Genet A. 2011;155A:2091–2097.

● Kimonis
VE, et al. Clinical manifestations in 105 persons with nevoid basal cell carcinoma syndrome.
Am J Med Genet. 1997;69:299–308.

● Gorlin
Syndrome Alliance. Voice of the Patient Report: Basal Cell Carcinoma Nevus Syndrome. Submitted
to FDA, 2018.

● National
Organization for Rare Disorders (NORD). Nevoid Basal Cell Carcinoma Syndrome.

Current
Treatment Paradigm

Patients with BCCNS are typically managed by dermatologists and frequently require treatment by Mohs micrographic surgeons as part of
ongoing care. As a result, we believe that Mohs surgeons represent a concentrated and identifiable group of specialists involved in the
management of this patient population. We further believe that this group consists of approximately 1,000 to 1,500 specialists in the
United States, and that this concentrated prescriber base may be relevant in the context of potential future commercialization or strategic
transactions.

Management
of basal cell carcinomas in patients with BCCNS remains predominantly procedural. Standard care generally consists of repeated Mohs micrographic
surgery, surgical excision, curettage, electrodessication and other lesion-directed dermatologic interventions as tumors arise (National
Comprehensive Cancer Network; American Academy of Dermatology). These approaches are effective for removing individual lesions but do
not address the underlying predisposition to continued tumor development.

In
selected cases, systemic therapies such as Hedgehog pathway inhibitors may be used, particularly in patients with locally advanced or
inoperable disease. Approved agents including vismodegib and sonidegib have demonstrated clinical activity in basal cell carcinoma; however,
their use may be limited by tolerability considerations and discontinuation rates in some patients (Sekulic et al., 2012; Migden et al.,
2015). As a result, many patients with BCCNS continue to rely primarily on repeated procedural interventions over time.

We
believe the current treatment paradigm reflects a reactive, lesion-by-lesion approach to disease management, which may result in a cumulative
procedural burden for patients given the chronic and recurring nature of BCCNS.

Selected
References

● National
Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Basal Cell
Skin Cancer.

● American
Academy of Dermatology (AAD). Guidelines of Care for the Management of Basal Cell Carcinoma.

● Sekulic
A, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med.
2012;366:2171–2179.

● Migden
MR, et al. Treatment with two different doses of sonidegib in patients with advanced basal
cell carcinoma. Lancet Oncol. 2015;16:716–728.

Illustrative
Monthly Procedural Cost Ranges in BCCNS

Tumor burden period
Illustrative monthly

procedural cost
Illustrative annualized range

Low burden
$2,000 - $3,500
$24,000 - $42,000

Moderate burden
$4,500 - $7,500
$54,000 - $90,000

High burden
$7,500 - $14,500 +
$90,000 - $174,000 +

Our
Program and Clinical Experience with Itraconazole

Our
lead clinical dataset comes from Study HP2001, a Phase IIb open-label study of itraconazole in patients with BCCNS. According to our
February 2026 FDA meeting materials, the study enrolled 38 patients with 477 surgically eligible target basal cell carcinomas at baseline.
In those materials, we reported a per-lesion objective response rate of 57.7% and a patient-level disease control rate of 97.4%.

In
a separate scientific and strategic review prepared for the program, we further summarized lesion-level outcomes as follows: 27.3% of
lesions resolved completely, an additional 30.4% achieved partial response, 39.4% remained stable or modestly reduced, and only 2.9%
exhibited measurable growth during therapy. That review also reported a median duration of tumor reduction of 505 days. We believe these
data support the concept of itraconazole as a chronic tumor-control therapy for a disease defined by repeated emergence of independent
lesions.

4

Our
FDA briefing materials also emphasize that BCCNS presents a unique endpoint challenge because patients develop numerous independent primary
tumors rather than a single clonally related mass. For that reason, we have sought Agency feedback on whether per-lesion analysis is
an appropriate primary efficacy framework for this indication and whether the existing HP2001 dataset, together with the known safety
profile of itraconazole, may support an NDA strategy.

Scientific
Rationale: Anti-Angiogenic Activity

Our
scientific positioning for itraconazole in BCCNS is centered on anti-angiogenesis. Itraconazole has been reported to interfere with vascular
endothelial growth factor receptor 2 (“VEGFR2”) trafficking and glycosylation, thereby reducing VEGF-driven signaling and
neovascularization (Chong et al., 2007; Aftab et al., 2011). Published preclinical studies cited in our scientific review indicate that
itraconazole can reduce endothelial migration, sprouting and microvessel density, effects that are directly relevant to tumor vascular
support (Chong et al., 2007).

Our
materials also describe a complementary endothelial mechanism involving VDAC1, AMP-activated protein kinase and mTORC1. In this framework,
itraconazole disrupts endothelial bioenergetics, activates AMPK and suppresses mTORC1, which can reduce endothelial proliferation and
angiogenesis (Aftab et al., 2011). We believe this anti-angiogenic profile is particularly relevant in BCCNS because patients develop
continual waves of new lesions over time, and vascular suppression offers a disease-control rationale not limited to a single lesion
or treatment episode.

A
further advantage for a cutaneous oncology program is skin exposure. Published pharmacokinetic work summarized in our scientific review
indicates that itraconazole achieves sebum concentrations approximately 5 to 10 times higher than plasma, with sustained deposition in
the stratum corneum after treatment (Abuhelwa et al., 2015). We believe this skin-distribution profile supports the biological plausibility
of chronic oral itraconazole as a systemic therapy for a disease manifested primarily in the skin.

Selected
References

● Chong
CR, et al. Inhibition of angiogenesis by the antifungal drug itraconazole. Cancer Cell. 2007;11:403–413.

● Aftab
BT, et al. Itraconazole inhibits angiogenesis and tumor growth. Cancer Res. 2011;71:6764–6772.

● Abuhelwa
AY, et al. Itraconazole pharmacokinetics and tissue distribution. Clin Pharmacokinet. 2015;54:375–390.

Formulation
Strategy, Avior Relationship and Economic Implications

We
engaged Avior to develop what we refer to internally as Micro-ITRA, a proprietary micronized/amorphous itraconazole formulation intended
for long-term administration in BCCNS. We retain all rights to this formulation and any associated intellectual property arising from
its development. Our scientific materials describe this formulation as designed to improve dissolution, bioavailability and plasma consistency.
We believe these characteristics may be important both clinically and commercially: clinically, because they may support more predictable
systemic exposure over chronic dosing; commercially, because a differentiated formulation may provide a basis for patent protection and
help distinguish our program from commodity itraconazole products. We believe this formulation represents a core proprietary component
of our development strategy and is intended to serve as the basis for our regulatory, intellectual property and commercial positioning.

We
intend to pursue patent protection covering the Avior formulation and related methods of use. If obtained, this protection could operate
alongside existing and potential regulatory exclusivities to strengthen the durability of the asset. From an economic standpoint, additional
formulation-based protection may reduce substitution risk, support lifecycle management, extend the period over which we may negotiate
commercial value with partners and enhance the overall strategic attractiveness of the program in a licensing or divestment process.
We believe that ownership of a differentiated formulation may be important in supporting exclusivity, reducing generic substitution risk
and enhancing the potential value of the program in any future strategic transaction.

We
also believe the formulation work may fit well with a 505(b)(2) strategy. FDA guidance explains that section 505(b)(2) can be appropriate
for applications that rely in part on investigations not conducted by or for the applicant and for which the applicant does not have
a right of reference, including published literature or prior Agency findings of safety and effectiveness for an approved drug. Subject
to FDA feedback, we believe that pairing existing itraconazole clinical and safety knowledge with a differentiated formulation and appropriate
bridging data could create an efficient regulatory and economic pathway for the program.

5

Regulatory
Strategy and Potential Exclusivity

Our
current regulatory focus is on obtaining FDA alignment regarding endpoint selection, data sufficiency and filing strategy. The FDA’s
formal meeting guidance states that Type C meetings are used to discuss development and review issues other than those assigned to Type
A or Type B meetings. Through the Type C interaction granted for our program, we are seeking guidance on whether the HP2001 dataset can
support a registration strategy, whether per-lesion response is an acceptable efficacy framework in BCCNS and whether our program may
be appropriate for expedited programs.

We
are also evaluating potential eligibility for Fast Track designation, Breakthrough Therapy designation, Accelerated Approval and Priority
Review. FDA describes these programs as tools intended to expedite development or review for therapies that address serious conditions
and unmet medical need. We already hold orphan-drug designation for itraconazole in BCCNS. FDA states that orphan designation provides
the potential for seven years of market exclusivity after approval, separate from patent rights, for the approved rare-disease use if
statutory and factual requirements are satisfied at approval.

Taken
together, we believe our regulatory strategy is important not only for development efficiency but also for asset value. A successful
505(b)(2) path, if available, may reduce development complexity relative to a full development program. Orphan exclusivity, if realized
upon approval, may provide a protected commercial window. Additional formulation patent protection, if granted, could extend the practical
economic life of the asset beyond regulatory exclusivity.

Market
Opportunity and Economic Framework

Our
internal economic report frames BCCNS as a chronic specialty dermatology opportunity rather than a conventional acute-treatment market.
Using an estimated U.S. BCCNS population of approximately 11,000 patients (Bree & Shah, 2011; National Organization for Rare Disorders),
one-third market penetration would correspond to roughly 3,700 treated patients annually. At an illustrative therapy price of $4,000
per month, annual gross revenue at that penetration level would be approximately $178 million; at $5,000 per month, annual gross revenue
would be approximately $222 million.

We
view those price levels as grounded in the structural economics of current care (Guy et al., 2015; American Academy of Dermatology).
Our economic work emphasizes that itraconazole is intended to shift care from episodic, procedure-driven intervention toward more predictable
chronic disease management, not to eliminate surgery entirely. In that framework, the commercial value proposition is tied to reducing
procedure frequency and intensity over time, improving predictability for patients and payors, and offering a fixed-price systemic approach
in a population defined by lifelong recurrent procedural burden.

Although
any commercial outcome will depend on regulatory approval, physician adoption, reimbursement, competition and other factors, we believe
the BCCNS program has attributes that are attractive from an economic standpoint: a defined rare-disease population, a concentrated prescriber
base, significant unmet need, relatively straightforward oral administration, and the potential for layered exclusivity if orphan protection
and formulation patents are realized.

Selected
References

● Bree
AF, Shah MR. Am J Med Genet A. 2011;155A:2091–2097.

● National
Organization for Rare Disorders (NORD). Nevoid Basal Cell Carcinoma Syndrome.

● American
Academy of Dermatology (AAD). Skin Cancer Data and Treatment Overview.

● Guy
GP Jr, et al. Prevalence and costs of skin cancer treatment in the U.S. Am J Prev Med. 2015;48:183–187.

● Company
estimates based on published literature, publicly available data and internal analyses.

Illustrative
Economic Snapshot

Illustrative assumption
Case 1
Case 2

Estimated U.S. BCCNS population
11,000
11,000

Illustrative treated patients at one-third penetration
~3,700
~3,700

Illustrative monthly therapy price
$4,000
$5,000

Illustrative annual gross revenue
~$178 million
~$222 million

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Intellectual
Property

On
December 12, 2023, we entered into an Exclusive License Agreement with Johns Hopkins University pursuant to which we obtained exclusive
worldwide rights to U.S. Patent No. 8,980,930, entitled “New Angiogenesis Inhibitors.” We believe this licensed asset supports
the development of itraconazole as an oncology therapeutic and remains an important foundational component of our intellectual property
estate.

In
addition to this licensed patent, our current intellectual property efforts are focused on the Avior formulation and related methods
of treatment in BCCNS. We intend to continue evaluating additional patent opportunities that may strengthen the program’s defensibility
and commercial life. We also rely on trade secrets, know-how and development data as part of our overall strategy to protect program
value.

Commercial
and Strategic Alternatives

We
do not currently market any FDA-approved products and have not established a commercial sales infrastructure. At this stage, our primary
commercial strategy is to advance the BCCNS program through regulatory development toward potential approval and to evaluate strategic
transactions that may maximize the value of the program. These may include regional or global licensing, co-development arrangements,
strategic partnerships or divestment of the program or related assets.

We
are actively evaluating potential strategic transactions and may engage with pharmaceutical or biotechnology companies that have development,
regulatory and commercial capabilities in dermatology or oncology. Any such transaction may include upfront payments, development and
regulatory milestones, royalties on future net sales or other forms of consideration, although there can be no assurance that any agreement
will be completed on acceptable terms, or at all.

We
believe that pursuing strategic transactions may allow us to leverage external development, regulatory and commercial capabilities while
reducing capital requirements and execution risk. In addition, we believe that advancing the program through key regulatory milestones,
including potential FDA feedback and, if applicable, approval, may enhance its attractiveness as a potential licensing or divestment
opportunity. We may seek to retain economic participation in any such transaction through milestone payments, royalties or other structured
consideration.

Competition

The
BCCNS treatment landscape includes repeated procedural intervention, non-pharmacologic management strategies such as rigorous sun protection,
and systemic treatment approaches that may be used in selected settings. Competition may also arise from companies pursuing therapies
for basal cell carcinoma or rare dermatology populations more broadly.

Our
principal competitive challenge is not solely another drug candidate, but the entrenched procedural standard of care. We believe our
program is differentiated by its chronic disease-control positioning, oral route of administration, existing body of itraconazole safety
knowledge, anti-angiogenic rationale, and the possibility of supporting differentiated access and exclusivity through formulation and
regulatory strategy.

Government
Regulation

Pharmaceutical
products are subject to extensive regulation in the United States and other jurisdictions. In the United States, the FDA regulates, among
other things, preclinical and clinical development, manufacturing, labeling, approval, marketing, promotion and post-approval reporting.
Before a drug may be marketed in the United States, the sponsor generally must complete applicable development work, submit an NDA and
obtain FDA approval.

Our
program is expected to be regulated as a drug product. Depending on FDA feedback, our future regulatory path may involve a 505(b)(2)
NDA strategy, chemistry, manufacturing and controls work related to our proprietary formulation, inspection of manufacturing facilities
and, if applicable, post-approval commitments or pharmacovigilance requirements.

7

Human
Capital Resources

As
of the date of this Report, we have two full-time employees and six part-time employees. The full-time employees include our Executive
Chairman who is involved in our clinical development program history and status, as well as vetting additional opportunities and operations,
as well as our Vice President of Operations. The part-time employees include our Interim CFO, as well as administrative, legal and accounting
functions. None of our employees are covered by collective bargaining agreements. From time to time, we also employ independent contractors
to support our clinical development and administrative functions. We consider the number of our employees, their compensation, and their
functions to be appropriate for the current status of our business, and we also consider relations with each of our employees to be good.
Each of our employees has entered into confidentiality, intellectual property assignment and non-competition agreements with us.

Corporate
History

We
were founded under the name “Commonwealth Biotechnologies, Inc.” in Virginia in 1992, and completed an initial public offering
in October 1997 (we refer to our company prior to our emergence from bankruptcy as CBI). CBI previously provided, on a contract basis,
specialized life sciences services to the pharmaceutical and biotechnology sector. On January 20, 2011, CBI filed a voluntary petition
for bankruptcy. We recommenced our business operations in August 2013 as a Delaware corporation following the emergence of CBI from its
voluntary bankruptcy.

After
approximately five years of extended litigation between a minority shareholder and the former majority shareholder of the Company, the
matter was finalized through mediation in 2022. As part of the settlement agreement, the former majority shareholder surrendered all
equity securities of the Company for cancellation. Certain defendants in the litigation were directors and officers of the Company at
the time, and as a result of the legal settlement, resigned from these positions. New officers and directors were then elected and the
Company continued under new management.

Available
Information

Our
Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant to
Sections 13(a) and 15(d) of the Exchange Act are filed with the SEC. Such reports and other information that we file with the SEC are
available free of charge on our website at http://www.inhibitortx.com when such reports are available on the SEC website. The SEC maintains
an Internet site that contains reports, proxy and information statements and other information regarding issuers like us that file electronically
with the SEC at http://www.sec.gov. The contents of these websites are not incorporated into this filing. Further, the foregoing references
to the URLs for these websites are intended to be inactive textual references only.

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