What changed in this filing

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Item 1. Business

2026-05-04 compared with 2025-04-15 · 1433 added, 619 removed, 806 unchanged (72% of the section changed)

On December 1, 2025, Apimeds Pharmaceuticals US, Inc.,

a Delaware corporation (“ APUS ”, the “ Company ,” “ we ,” “ us ,”

or “ our ”) entered into and closed an Agreement and Plan of Merger (the “ Merger Agreement ”), with

Apimeds Merger Sub, Inc., a Delaware corporation (“ Merger Sub ”), MindWave Innovations Inc, a Delaware corporation (“ MindWave ”),

Lokahi Therapeutics, Inc., a Nevada corporation (“ Bio Sub ”), and Erik Emerson, solely in his capacity as representative

for the Bio Business (the “ Bio Business Representative ”).

The transactions contemplated by the Merger Agreement are

referred to herein as the “ Transactions ” and the closing of the Transactions is referred to herein as the “ Closing ”.

Pursuant to the terms and conditions of the Merger

Agreement, immediately prior to the Closing, a certificate of merger (the “ Certificate of Merger ”) was filed with the

Secretary of State of the State of Delaware (the “ DE SOS ”) (such time of the filing of the Certificate of Merger, the

“ Effective Time ”), in accordance with the DGCL.

Pursuant to the Certificate of Merger, Merger Sub was merged with

and into MindWave (the “ Merger ”), with MindWave surviving the Merger as the surviving corporation (the “ Surviving

Corporation ”).

As a result of the Merger, MindWave became a direct wholly owned subsidiary of the Company.

At the Effective

Time, all of the property, rights, privileges, powers and franchises of MindWave and Merger Sub vested in the Surviving Corporation and

all of the debts, liabilities and duties of MindWave and Merger Sub became the debts, liabilities and duties of the Surviving Corporation.

The Closing occurred simultaneously with the execution and delivery of the Merger Agreement on the Closing Date.

At the Effective Time, (i) each share of MindWave

common stock issued and outstanding immediately prior to the Effective Time shall be canceled and converted into the right to receive

a portion of the Merger Consideration, consisting of shares of Company Preferred Stock;

and (ii) each holder of such shares shall

receive, for each share of MindWave Common Stock held immediately prior to the Effective Time, a pro rata portion of the Merger Consideration,

allocated as follows:

(A) a number of duly authorized, validly issued, fully paid and nonassessable shares of Company Common Stock,

such that the aggregate number of shares of Company Common Stock issued to all holders of MindWave Common Stock shall equal 0% of the

total number of shares of Company Common Stock issued and outstanding as of the date of the Merger Agreement (the “ Common Stock

Cap ”), with each holder’s allocation rounded down to the nearest whole share;

and (B) a number of duly authorized,

validly issued, fully paid and nonassessable shares of Company Preferred Stock, such that, immediately following the Effective Time, the

holders of MindWave Common Stock collectively hold, on an as-converted to Company Common Stock basis, 90.9% of the total issued and

outstanding equity securities of the Company (exclusive of the Company Common Stock issued pursuant to clause (A) and calculated

on a fully diluted basis).

The shares of Company Common Stock and Company Preferred Stock issued to holders of MindWave Common Stock pursuant

to the Merger Agreement, on an as-converted and fully diluted basis, shall collectively represent 90.9% of the equity capital of

the Company as of the Closing.

For purposes of the Merger Agreement, the shares of Company Common Stock, Company Preferred Stock, and

MindWave Common Stock issued pursuant to the Merger Agreement are collectively referred to as the “ Merger Consideration .”

In connection with the Merger Agreement, on December 1,

2025, certain stockholders of the Company, collectively holding approximately 51% of the Company’s shares of common stock, par value

$0.01 per share (the “ Common Stock ”), approved by written consent in lieu of a special meeting (the “ Written

Consent ”), in accordance with Section 228 of the Delaware General Corporation Law (the “ DGCL ”) and the

Company’s Amended and Restated Certificate of Incorporation, the following actions (the “ Corporate Actions ”):

The Preferred Stock Conversion and Issuance :

the issuance of Company Common Stock upon

the conversion (the “ Preferred Stock Conversion ”) of the Series A Convertible Preferred Stock, par value $0.01

per share of the Company (the “ Preferred Stock ”);

The Notes Conversion and Issuance :

the issuance of Company Common Stock upon the conversion

of the convertible notes (the “ Notes Conversion ”) issued by the Company pursuant to that certain Securities Purchase

Agreement, entered into by the Company and certain institutional investors on December 1, 2025, and amended by that certain Amendment

1 to Securities Purchase Agreement on December 8, 2025;

The Reverse Stock Split :

a 1-for-10 reverse stock split (the “ Reverse

Stock Split ”) of the Company’s Common Stock, a change in the par value per share of the Company’s Common Stock from

$0.01 to $0.001 (the “ Change in Par Value ”), and a corresponding amendment (the “ Charter Amendment ”)

to the Company’s Amended and Restated Certificate of Incorporation (the “ Charter ”) to (i) authorize the

Board of Directors to effect the Reverse Stock split and (ii) the Change in Par Value;

The 2024 Plan Share Increase :

an amendment to the Apimeds Pharmaceuticals US, Inc.

2024 Equity Incentive Plan (the “ 2024 Plan ”) to increase the number of shares of Common Stock issuable under the 2024

Plan to 2,096,679;

The 2025 Equity Plan :

the approval and adoption the Apimeds Pharmaceuticals US, Inc.

2025 Equity Incentive Plan (the “ 2025 Plan ”).

In connection with such Corporate Actions, the Company

filed and mailed an information statement (the “ Information Statement ”) to its stockholders pursuant to Rule 14c-2

under the Securities Act of 1934, as amended.

The Corporate Actions will not become effective until at least 20 calendar days after the

mailing of the definitive Information Statement (the “ Waiting Period ”).

Following the expiration of the Waiting Period,

or March 25, 2026, the Company expects to file the Charter Amendment with the Secretary of State of the State of Delaware to effect the

Reverse Stock Split and the Change in Par Value.

As a result of the Merger, the Preferred Stock Conversion,

and the Notes Conversion, a change in control of the Company will occur within the meaning of the NYSE American Company Guide.

the Company will be required to submit a new listing application to NYSE American (the “ Listing Application ”).

stockholder approval of the Preferred Stock Conversion and the Notes Conversion has been obtained by the Written Consent, which will become

effective at the Action Effective Time, the Company does not intend to effect the Preferred Stock Conversion and the Notes Conversion

unless and until NYSE American has approved the Listing Application.

There can be no assurance that NYSE American will approve the Listing

If such approval is not obtained, the Preferred Stock Conversion and the Notes Conversion will not be completed.

INFORMATION ABOUT THE BUSINESS OF APIMEDS PHARMACEUTICALS

Unless the context otherwise indicates or requires,

all references in this section to “we,” “us,” “our,” “our company” “the Company”

and “Apimeds US” refer to Apimeds Pharmaceuticals US, Inc.

The Company conducts its business through two

wholly-owned operating subsidiaries, Lokahi Therapeutics, Inc.and MindWave Innovations Inc.

INFORMATION ABOUT THE BUSINESS OF LOKAHI THERAPEUTICS,

Unless the context otherwise indicates or requires,

all references in this section to “we,” “us,” “our,” “our company” “the Company”

and “Lokahi” refer to Lokahi Therapeutics, Inc.

We are a clinical stage biopharmaceutical company

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by the FDA for any indication.

Apitox is a purified, pharmaceutical grade venom

(bee venom), of the Apis mellifera, or western honeybee, which is classified by the FDA as an active pharmaceutical ingredient

Apitox is a purified, pharmaceutical grade venom (bee

venom), of the Apis mellifera, or western honeybee, which is classified by the FDA as an active pharmaceutical ingredient

Bee venom has been used in Asia and Europe to treat pain for hundreds of years.

While not FDA approved in a

controlled, prescription based biologic environment for defined indications, the use of bee venom has been FDA approved as a “under

While not FDA approved

in a controlled, prescription based biologic environment for defined indications, the use of bee venom has been FDA approved as a “under

the skin injection” to reduce the allergic reactions to bee stings.

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Apimeds Korea successfully completed Phase I,

Phase II, and Phase III trials in OA in 2003, at which point Apitoxin was approved by the Korean Ministry of Food and Drug Safety (“MFDA”)

to treat pain and mobility in patients with OA.

Since 2003, a post-marketing/approval safety study in South Korea followed 3,194 patients

from 2003 through 2009, with no serious adverse events.

The purpose of a Phase I trial is to test to determine whether a new

treatment is safe and look for the best way to give the treatment.

Phase II trials test to determine whether a condition or disease

responds to the new treatment.

Phase III trials test to determine whether a new treatment is better than a standard treatment.

Phase II, and Phase III trials in OA in 2003, at which point Apitoxin was approved by the Korean Ministry of Food and Drug Safety

(“MFDA”) to treat pain and mobility in patients with OA.

Since 2003, a post-marketing/approval safety study in South

Korea followed 3,194 patients from 2003 through 2009, with no serious adverse events.

The purpose of a Phase I trial is to test

to determine whether a new treatment is safe and look for the best way to give the treatment.

Phase II trials test to determine whether

a condition or disease responds to the new treatment.

Phase III trials test to determine whether a new treatment is better than a

standard treatment.

In 2013, the first of two required U.S.

III clinical trials was authorized to enroll patients to study the use of Apitoxin to study the same indication as approved in South Korea

clinical trials was authorized to enroll patients to study the use of Apitoxin to study the same indication as approved in South Korea

in 2023 — treatment of pain and lack of mobility in patients with OA (the “ Apimeds Korea Phase III OA Trial ”).

The Apimeds Korea Phase III OA Trial (330 patients) was completed in 2018, and displayed no serious adverse events.

Based on the results from the Apimeds Korea Phase

III OA Trial, which demonstrated therapeutic (statistical and clinically significant improvements in all outcome measures of pain, physical

Based on the results from the Apimeds Korea Phase III

OA Trial, which demonstrated therapeutic (statistical and clinically significant improvements in all outcome measures of pain, physical

function, and disease assessment) effect compared to the placebo group, but in combination with prior development by Apimeds Korea, did

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inadequate, resulting in a study that did not demonstrate a significant treatment effect.

We will be pursuing a second Phase III trial

to meet agreed upon FDA standards.

We will be pursuing a second Phase III

trial to meet agreed upon FDA standards.

Based on results from the Apimeds Korea Phase III OA Trial, we have evaluated the most appropriate

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to progress our own Phase III trial.

Pursuant to our previous correspondence with the FDA, we have designed and will implement our Phase

III trial to best address our patient population, appropriate dosing, and the most effective way to evaluate Apitox in meeting the patient

population’s needs.

Pursuant to our previous correspondence with the FDA, we have designed and will implement our

Phase III trial to best address our patient population, appropriate dosing, and the most effective way to evaluate Apitox in meeting

the patient population’s needs.

We believe the progress we are making in clinical

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Treatment of OA

OA is typically treated with painkillers known

as non-steroidal anti-inflammatory drugs (NSAIDs).

OA is typically treated with painkillers known as non-steroidal

anti-inflammatory drugs (NSAIDs).

These medications have an anti-inflammatory and pain-relieving effect.

These medications

include ibuprofen (Motrin, Advil) naproxen (Aleve) and diclofenac (Voltaren and others).

All of these medications work by blocking enzymes

that cause pain and swelling.

These medications include ibuprofen

(Motrin, Advil) naproxen (Aleve) and diclofenac (Voltaren and others).

All of these medications work by blocking enzymes that cause pain

and swelling.

The problem is that some of those enzymes also help blood to clot and protect the lining of your stomach.

Without them, you can bruise easily, develop ulcers and may even bleed in your intestines.

NSAIDs also increase your chance of heart attack,

stroke and heart failure.

Without them,

you can bruise easily, develop ulcers and may even bleed in your intestines.

NSAIDs also increase your chance of heart attack, stroke

and heart failure.

The risk increases the longer you use them and the more you take.

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to NSAIDs in the treatment of the inflammation and pain management symptoms associated with OA without the harmful side effects.

According to MedicalNewsToday, OA is the most

common form of arthritis, affecting around 500 million people worldwide, or around 7% of the global population.

Currently, in the

United States, over 32 million people suffer from OA.

As the 15 th highest cause of years lived

with disability (YLDs) worldwide, the burden OA poses to individuals is substantial, characterized by pain, activity limitations, and

reduced quality of life.

The economic impact of OA, which includes direct and indirect (time) costs, is also substantial, ranging

from 1 to 2.5% of gross national product (GNP) in countries with established market economies, like the United States.

Though trends

in OA prevalence vary by geography, the prevalence of OA is projected to rise in regions with established market economies such as North

America and Europe, where populations are aging and the prevalence of obesity is rising.

While OA can occur in any joint, it occurs most

frequently in the knee, which, according to ScienceDirect, currently accounts for 365 million cases worldwide and 61% of YLDs lost

due to OA, followed by the hand.

According to MedicalNewsToday, OA is the most common

form of arthritis, affecting around 500 million people worldwide, or around 7% of the global population.

Currently, in the United States, over

32 million people suffer from OA.

As the 15 th highest cause of years lived with disability (YLDs)

worldwide, the burden OA poses to individuals is substantial, characterized by pain, activity limitations, and reduced quality of

The economic impact of OA, which includes direct and indirect (time) costs, is also substantial, ranging from 1 to 2.5% of gross

national product (GNP) in countries with established market economies, like the United States.

Though trends in OA prevalence vary

by geography, the prevalence of OA is projected to rise in regions with established market economies such as North America and Europe,

where populations are aging and the prevalence of obesity is rising.

While OA can occur in any joint, it occurs most frequently

in the knee, which, according to ScienceDirect, currently accounts for 365 million cases worldwide and 61% of YLDs lost due to OA,

followed by the hand.

Our current efforts are focused on the development

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Treatment of MS

Additionally, we believe the previous clinical

trial success of Apimeds Korea with respect to the use of Apitoxin to treat symptoms associated with knee OA, and pending the success

of our anticipated Phase III trial in knee OA, we will be in a position to further explore the use of Apitox as a potential treatment

for the symptoms of MS.

Additionally, we believe the previous clinical trial

success of Apimeds Korea with respect to the use of Apitoxin to treat symptoms associated with knee OA, and pending the success of our

anticipated Phase III trial in knee OA, we will be in a position to further explore the use of Apitox as a potential treatment for

the symptoms of MS.

MS is a chronic disease of the central nervous system.

It is an autoimmune condition that is characterized

by the body’s own immune cells (macrophages and lymphocytes) attacking the myelin that coats nerve cells, which can lead to

inflammation throughout the central nervous system.

It is an autoimmune condition that is characterized by

the body’s own immune cells (macrophages and lymphocytes) attacking the myelin that coats nerve cells, which can lead to inflammation

throughout the central nervous system.

MS is an unpredictable disease that affects people differently.

Some people with MS

may have only mild symptoms.

Others may lose their ability to see clearly, write, speak, or walk when communication between the brain

and other parts of the body becomes disrupted.

Some people with MS may have only

mild symptoms.

Others may lose their ability to see clearly, write, speak, or walk when communication between the brain and other parts

of the body becomes disrupted.

MS is the most common progressive neurologic disease

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at a young age, resulting in a greater loss of productivity and quality of life.

Beta interferon drugs are among the most common

medications used to treat MS.

Beta interferon drugs are among the most common medications

used to treat MS.

Interferons are signaling molecules that regulate immune cells.

Potential side effects of these drugs

include flu-like symptoms (which usually fade with continued therapy), depression, or elevation of liver enzymes.

Potential side effects of these drugs include flu-like

symptoms (which usually fade with continued therapy), depression, or elevation of liver enzymes.

Pain from MS can be felt in different

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OA and the Current Standard of Care

OA is a degenerative joint disease in which

the tissues in the joint break down over time.

OA is a degenerative joint disease in which the

tissues in the joint break down over time.

It is the most common type of arthritis and is more common in older people.

osteoarthritis usually have joint pain and, after rest or inactivity, stiffness for a short period of time.

People with osteoarthritis

usually have joint pain and, after rest or inactivity, stiffness for a short period of time.

There are four stages of OA:

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of bony spurs may cause severe pain.

With the progression of OA of the knee, there

is obvious joint inflammation which causes frequent pain when walking, running, squatting, extending or kneeling.

Along with joint stiffness

after sitting for long or when waking up in the morning, there may be popping or snapping sounds when walking.

The data from the Apimeds Korea Phase III OA Trial

suggest that Apitox would have the most potential in treating OA in stages 3 and 4.

With the progression of OA of the knee, there is obvious

joint inflammation which causes frequent pain when walking, running, squatting, extending or kneeling.

Along with joint stiffness after

sitting for long or when waking up in the morning, there may be popping or snapping sounds when walking.

The data from the Apimeds Korea Phase III OA

Trial suggest that Apitox would have the most potential in treating OA in stages 3 and 4.

MS and the Current Standard of Care

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(evidence of disability accrual over time, with or without relapse or new MRI activity) or without progression.

Patients with MS tend to be more educated about

their disease and better organized than patients with other diseases, resulting in patients that are aggressive in their approach to treatment.

Patients with MS tend to be more educated about their

disease and better organized than patients with other diseases, resulting in patients that are aggressive in their approach to treatment.

This is due to MS impacting otherwise healthy people in the prime of their lives.

MS treatment has undergone significant evolution

in the last ten years with the development and approval of certain new drugs, including several oral agents such as Ocrevus, in the

MS treatment has undergone significant evolution in

the last ten years with the development and approval of certain new drugs, including several oral agents such as Ocrevus, in the

United States.

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OA Trial suggest that Apitox may have the potential as an adjunctive therapy for all four types of MS.

We intend to Apitox as a potential

adjunctive therapy through non-registered corporate sponsorship studies to begin determining the appropriate MS patient populations.

We intend to explore Apitox

as a potential adjunctive therapy through non-registered corporate sponsorship studies to begin determining the appropriate MS patient

Market Opportunity

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diseases that involve difficult to control pain and inflammation.

According to Pharmaceutical Technology the MS

market size in the United States accounted for $10.73 billion in 2022 and is expected to hit $24.4 billion by 2030, expanding

According to Pharmaceutical Technology the MS market

size in the United States accounted for $10.73 billion in 2022 and is expected to hit $24.4 billion by 2030, expanding

at a CAGR of 10.32%.

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of our Phase III data may lead to a small indication for narcotic use reduction in the treatment of stage 4 OA.

Lokahi partners with

universities to give students hands-on exposure to the strategic side of biopharma, from evaluating clinical assets to understanding intellectual

property, market dynamics, and go-to-market strategies.

The ai² Futures Lab™ functions as both a discovery engine for potential

therapeutic assets and a training ground for the next generation of biotech and business leaders.

Our Product Candidate

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the toxicity and safety of Apitoxin in 20 healthy subjects.

The purpose of the Phase I trial was to determine if therapeutic doses of

Apitoxin was safe and to identify possible side-effects, if any.

Injections of Apitoxin were given two to three times a week, for a total

of 12 sessions spanning over four to six weeks.

Laboratory and physical examination of the subjects included (i) serum cortisol levels

(to see if Apitoxin stimulated the release of cortisol), (ii) serum ionized calcium level (to determine if Apitoxin decreased the serum

calcium level), (iii) urinalysis, (iv) hematology and blood chemistry, and (v) vital signs.

The Phase I trial demonstrated that there

were no significant changes pre- and post-testing of the serum cortisol levels, serum ionized calcium levels, hematology, blood chemistry,

urinalysis, and vital signs after the subjects were injected with Apitoxin according to the protocol.

There were no significant physiological

changes in the clinical evaluations of the subjects and localized itching was the most frequent side effect and was managed with ice packs

or external anti-itching gels.

The purpose of the Phase I trial was to determine if therapeutic doses

of Apitoxin was safe and to identify possible side-effects, if any.

Injections of Apitoxin were given two to three times a week, for a

total of 12 sessions spanning over four to six weeks.

Laboratory and physical examination of the subjects included (i) serum

cortisol levels (to see if Apitoxin stimulated the release of cortisol), (ii) serum ionized calcium level (to determine if Apitoxin

decreased the serum calcium level), (iii) urinalysis, (iv) hematology and blood chemistry, and (v) vital signs.

trial demonstrated that there were no significant changes pre- and post-testing of the serum cortisol levels, serum ionized calcium levels,

hematology, blood chemistry, urinalysis, and vital signs after the subjects were injected with Apitoxin according to the protocol.

were no significant physiological changes in the clinical evaluations of the subjects and localized itching was the most frequent side

effect and was managed with ice packs or external anti-itching gels.

No severe side effects or aftereffects were observed.

The Phase I trial indicated that Apitox is safe for

humans when applied in therapeutic doses.

The Phase I trial was followed by a Phase II trial

in 101 subjects to determine the efficacy of Apitoxin at various dose levels.

This was a randomized active-controlled clinical trial with

three groups receiving the study drug at various dose levels and one group receiving the control drug (nabumetone) for a six-week period.

Patients received twice weekly injections of Apitox intradermally at dosages titrated to a maximum of 0.7 mg (Group A), 1.5 mg (Group

B), and 2.0 mg (Group C) for a period of six weeks.

Control group patients (Group D) received 1,000 mg of nabumetone orally each day for

the same six-week period.

trial indicated that Apitox is safe for humans when applied in therapeutic doses.

The Phase I trial was followed by a Phase II

trial in 101 subjects to determine the efficacy of Apitoxin at various dose levels.

This was a randomized active-controlled clinical trial

with three groups receiving the study drug at various dose levels and one group receiving the control drug (nabumetone) for a six-week

Patients received twice weekly injections of Apitox intradermally at dosages titrated to a maximum of 0.7 mg (Group A), 1.5 mg

(Group B), and 2.0 mg (Group C) for a period of six weeks.

Control group patients (Group D) received 1,000 mg of nabumetone

orally each day for the same six-week period.

There were 25, 26, 25 and 25 patients assigned to Groups A, B, C and D, respectively.

Efficacy of treatment

was evaluated by the physician investigators using a 4-point Likert-like symptom severity rating scale developed by the authors to assess

Pain, Disability and Physical Signs.

Efficacy of treatment was evaluated by the physician investigators using a 4-point Likert-like symptom severity rating scale developed

by the authors to assess Pain, Disability and Physical Signs.

A similar 5-point scale was used for patient self-evaluation.

Safety of the Apitoxin injection was

evaluated by patient reaction, hematologic examination, and laboratory chemistry analysis of blood and urine.

Efficacy data was reported

for the 81 patients who completed the study.

While there were no significant differences in symptom severity scores among the four groups

at baseline, symptom scores were significantly better in the bee venom injection groups than in the control group at six weeks and 10

weeks after the start of treatment (p<0.01).

A treatment was considered effective if there was a 20% improvement from baseline in symptom

scores after 6 weeks of treatment.

Based on this definition, therapy demonstrated overall efficacy in 70.0% of patients in Group A, 85.7%

in Group B, 90.0% in Group C, and 61.9% in Group D (drug control).

Overall efficacy was significantly greater in treatment Groups

B and C combined than in the nabumetone-treated control group D (p<0.0177).

Importantly, efficacy of treatment among all patients treated

with Apitoxin injection was greater than among nabumetone-treated patients for each category assessed:

the Apitoxin injection was evaluated by patient reaction, hematologic examination, and laboratory chemistry analysis of blood and urine.

Efficacy data was reported for the 81 patients who completed the study.

While there were no significant differences in symptom severity

scores among the four groups at baseline, symptom scores were significantly better in the bee venom injection groups than in the control

group at six weeks and 10 weeks after the start of treatment (p<0.01).

A treatment was considered effective if there was

a 20% improvement from baseline in symptom scores after 6 weeks of treatment.

Based on this definition, therapy demonstrated overall

efficacy in 70.0% of patients in Group A, 85.7% in Group B, 90.0% in Group C, and 61.9% in Group D (drug control).

Overall efficacy

was significantly greater in treatment Groups B and C combined than in the nabumetone-treated control group D (p<0.0177).

efficacy of treatment among all patients treated with Apitoxin injection was greater than among nabumetone-treated patients for each category

85.2% versus 76.2%;

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and Physical Signs:

It is also noteworthy that, unlike the drug control group, the Apitoxin injection

groups continued to demonstrate improved symptom scores at four weeks after the last treatment (10 weeks).

There were no significant changes

in vital signs or results of laboratory examinations of any patient in this clinical trial.

Localized itching was experienced by all patients

who received Apitox injections.

Itching at the injection site generally lasted for two to three weeks;

several patients had this reaction

for a longer period.

This Phase II study showed that Apitoxin was significantly more effective than the control drug, nabumetone, in the

treatment of knee and spinal osteoarthritis patients.

It clearly showed that improvement in pain, disability and physical signs was greater

in the bee venom injection groups than in the nabumetone control group.

No significant side effects developed at the therapeutic doses

However, research should be continued to minimize itching and pain at bee venom injection sites, and possible allergic reaction

should always be considered with treatment at high doses.

In 2002, a formal Phase III double-blind, placebo-controlled

trial was completed with 407 subjects (311 of which obeyed the trial protocol and completed the clinical study).

The purpose of the Phase

III trial was conducted to verify the efficacy and safety of the medicine resulting from the prior Phase I and Phase II trials.

The therapeutic

course treatment included a total of 12 injections over a period of 6 weeks.

Final evaluations were completed in the 8 th week,

following two weeks of no injections.

During the trial period, laboratory tests were carried out three times (before injection, in the

second week, in the sixth week), and the efficacy evaluation was performed four times (before injection, in the second week, in the sixth

week, and in the eighth week).

Safety of the Apitoxin injection was evaluated by, hematologic examination, measurement of cortisol and

calcium levels, and laboratory chemistry analysis of blood and urine.

The primary efficacy variable for the trial was the ratio of the

subjects who showed more than 20% improvement in the total points of test items for efficacy evaluation 6 weeks after injection, compared

with the total points before injection of the medicine (the “improvement rate”).

Data obtained from subjects of the clinical

test were analyzed by two methods, ITT (Intention to Treat) analysis and PP (Per Protocol) Among 310 subjects who participated in the

efficacy evaluation, 153 and 157 patients belonged to the Apitoxin group and the nabumetone group, respectively.

For the Apitoxin group,

the ratio of the subjects who showed more than 20% improvement in the total points was 48.70% (75/154 subjects, 95% confidence interval

40.8~56.6%), while for the nabumetone group, it was 46.15% (72/156 subjects, 95% CI:

38.3~54.0%), indicating that

the improvement rate in the Apitoxin group was greater than in the nabumetone group;

It is also noteworthy that, unlike

the drug control group, the Apitoxin injection groups continued to demonstrate improved symptom scores at four weeks after the last

treatment (10 weeks).

There were no significant changes in vital signs or results of laboratory examinations of any patient in this

clinical trial.

Localized itching was experienced by all patients who received Apitox injections.

Itching at the injection site generally

lasted for two to three weeks;

several patients had this reaction for a longer period.

This Phase II study showed that Apitoxin

was significantly more effective than the control drug, nabumetone, in the treatment of knee and spinal osteoarthritis patients.

showed that improvement in pain, disability and physical signs was greater in the bee venom injection groups than in the nabumetone control

No significant side effects developed at the therapeutic doses studied.

However, research should be continued to minimize itching

and pain at bee venom injection sites, and possible allergic reaction should always be considered with treatment at high doses.

In 2002, a formal Phase III double-blind,

placebo-controlled trial was completed with 407 subjects (311 of which obeyed the trial protocol and completed the clinical study).

purpose of the Phase III trial was conducted to verify the efficacy and safety of the medicine resulting from the prior Phase I

and Phase II trials.

The therapeutic course treatment included a total of 12 injections over a period of 6 weeks.

Final evaluations

were completed in the 8 th week, following two weeks of no injections.

During the trial period, laboratory tests

were carried out three times (before injection, in the second week, in the sixth week), and the efficacy evaluation was performed four

times (before injection, in the second week, in the sixth week, and in the eighth week).

Safety of the Apitoxin injection was evaluated

by hematologic examination, measurement of cortisol and calcium levels, and laboratory chemistry analysis of blood and urine.

efficacy variable for the trial was the ratio of the subjects who showed more than 20% improvement in the total points of test items for

efficacy evaluation 6 weeks after injection, compared with the total points before injection of the medicine (the “improvement

Data obtained from subjects of the clinical test were analyzed by two methods, ITT (Intention to Treat) analysis and PP

(Per Protocol) Among 310 subjects who participated in the efficacy evaluation, 153 and 157 patients belonged to the Apitoxin group and

the nabumetone group, respectively.

For the Apitoxin group, the ratio of the subjects who showed more than 20% improvement in the total

points was 48.70% (75/154 subjects, 95% confidence interval (“CI”):

40.8~56.6%), while for the nabumetone group, it was 46.15%

(72/156 subjects, 95% CI:

38.3~54.0%), indicating that the improvement rate in the Apitoxin group was greater than in the nabumetone group;

however, there was no statistical significance.

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Nabumetone group:

203), 38.24% (78/204) of the Apitoxin group showed more than 20%

improvement during the 6 th week of injection, while 38.42% of the Nabumetone group improved by more than 20%, indicating that

the two groups showed similar improvement rate (p=0.9688).

The second efficacy variable was the improvement rate during the 8 th

week (2 weeks after the completion of the final injection).

According to results from comparing the total points of efficacy evaluation

items during the second week after completion of injection (during the 8 th week after injection) with the total points before

injection, 58.44% (90/154) of the Apitoxin group showed a higher improvement rate than during the 6 th week (48.70%), while

42.95% (67/156) of the Nabumetone group showed lower improvement rate than during the 6 th week (46.15%).

There was statistical

difference in total point of efficacy evaluation items between the two groups (p=0.0064).

These results suggest that even after treatment

stops, the efficacy of Apitoxin continues.

With respect to safety, among a total of 407 subjects who participated in the safety evaluation,

69 (33.82%) of the Apitoxin group showed an adverse event, while 59 (29.06%) of the Nabumetone indicated adverse event.

These results

indicate that the Apitoxin group had an elevated adverse event rate than the Nabumetone group, but there was no statistically significant

difference between the two groups (p=0.3526).

In May 2003, MFDA granted approval for the

use of Apitoxin in the treatment of pain and mobility in patients with OA.

A post-marketing/approval safety study in South Korea

followed 3,194 patients from 2003 through 2009, with no serious adverse events or negative safety signals.

38.24% (78/204) of the Apitoxin group showed more than 20% improvement during the 6 th week of injection, while 38.42%

of the Nabumetone group improved by more than 20%, indicating that the two groups showed similar improvement rate (p=0.9688).

efficacy variable was the improvement rate during the 8 th week (2 weeks after the completion of the final injection).

According to results from comparing the total points of efficacy evaluation items during the second week after completion of injection

(during the 8 th week after injection) with the total points before injection, 58.44% (90/154) of the Apitoxin group

showed a higher improvement rate than during the 6 th week (48.70%), while 42.95% (67/156) of the Nabumetone group

showed lower improvement rate than during the 6 th week (46.15%).

There was statistical difference in total point

of efficacy evaluation items between the two groups (p=0.0064).

These results suggest that even after treatment stops, the efficacy of

Apitoxin continues.

With respect to safety, among a total of 407 subjects who participated in the safety evaluation, 69 (33.82%) of the

Apitoxin group showed an adverse event, while 59 (29.06%) of the Nabumetone indicated adverse event.

These results indicate that the Apitoxin

group had an elevated adverse event rate than the Nabumetone group, but there was no statistically significant difference between the

two groups (p=0.3526).

In May 2003, MFDA granted approval for the use

of Apitoxin in the treatment of pain and mobility in patients with OA.

A post-marketing/approval safety study in South Korea followed

3,194 patients from 2003 through 2009, with no serious adverse events or negative safety signals.

In 2013, preliminary Phase III clinical trials

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and lack of mobility in patients with OA.

The results of the preliminary Phase III clinical trial indicated statistical and clinically

significant improvements in all outcome measures of pain, physical function, and disease assessment in the study group.

The study group

included 330 patients with diagnosed osteoarthritis of the knee.

The subjects were evaluated for relief of pain using Western Ontario

and McMaster Osteoarthritis Index (WOMAC) and physician and patient global assessments.

The primary efficacy measure was relief of pain

and inflammation over a 12-week treatment period after randomization into the trial.

The secondary efficacy measure was improvement of

The results of the preliminary Phase III clinical trial indicated statistical and

clinically significant improvements in all outcome measures of pain, physical function, and disease assessment in the study group.

study group included 330 patients with diagnosed osteoarthritis of the knee.

The subjects were evaluated for relief of pain using Western

Ontario and McMaster Osteoarthritis Index (WOMAC) and physician and patient global assessments.

The primary efficacy measure was relief

of pain and inflammation over a 12-week treatment period after randomization into the trial.

The secondary efficacy measure was improvement

Treatment effect will be compared in a 2-1 Apitox vs active control.

Compared with the placebo group (histamine), subjects in

the Apitox group who received a maximum dose (1500 micrograms) at each weekly visit over 12 weeks showed a significantly more improvement

in all outcome measures (WOMAC pain, WOMAC physical function, visual analog scale (“VAS”) pain, patient and physician global

assessments of OA).

Further, post hoc analyses showed that a statistically significant greater percentage of Apitox-treated subjects had

at least a 40% and 60% reduction in WOMAC pain as compared to placebo-treated subjects.

Sensitivity analyses confirmed the validity of

the statistical methods and population definitions.

The improvements in pain endpoints were highly significant for both the modified intention

to treat and per protocol populations and the improvement was sustained during the four weeks following Apitox treatment.

Compared with the placebo group (histamine), subjects

in the Apitox group who received a maximum dose (1500 micrograms) at each weekly visit over 12 weeks showed a significantly more

improvement in all outcome measures (WOMAC pain, WOMAC physical function, visual analog scale (“VAS”) pain, patient and physician

global assessments of OA).

Further, post hoc analyses showed that a statistically significant greater percentage of Apitox-treated subjects

had at least a 40% and 60% reduction in WOMAC pain as compared to placebo-treated subjects.

Sensitivity analyses confirmed the validity

of the statistical methods and population definitions.

The improvements in pain endpoints were highly significant for both the modified

intention to treat and per protocol populations and the improvement was sustained during the four weeks following Apitox treatment.

Except for an expected higher incidence of injection

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The incidence of adverse events overall was similar between the Apitox and Placebo groups

and 46.3%, respectively), and there were no clinically meaningful changes, within and between groups, in laboratory parameters, vital

signs, physical examination, or electrocardiogram results.

During Apimeds Korea meetings with the FDA, the

FDA highlighted concerns regarding the opioid crisis.

As Apitoxin has been previously approved in South Korea, we believe Apitox could

be a viable treatment option within the United States after additional clinical investigation, including our anticipated Phase III

(49.0% and 46.3%, respectively), and there were no clinically meaningful changes, within and between groups, in laboratory parameters,

vital signs, physical examination, or electrocardiogram results.

During Apimeds Korea meetings with the FDA, the FDA

highlighted concerns regarding the opioid crisis.

As Apitoxin has been previously approved in South Korea, we believe Apitox could be

a viable treatment option within the United States after additional clinical investigation, including our anticipated Phase III

Initially, Apimeds Korea elected not to pursue the OA indication in the United States based on its evaluation of potential

market adoption and the existing competitive environment for OA.

Based on results from the Apimeds Korea Phase III OA Trial and correspondence

with the FDA, we believe we are now in a position to continue to advance our Phase III trial for knee OA.

Based on results from the Apimeds Korea Phase III OA Trial

and correspondence with the FDA, we believe we are now in a position to continue to advance our Phase III trial for knee OA.

We intend to conduct an additional Phase III

trial in knee OA.

Based on our previous correspondence with the FDA, we have started to design and will implement our Phase III trial

to best address our patient population of patients with grade 2, 3 and 4 knee OA, appropriate dosing, and the most effective way to evaluate

Apitox in meeting a patient’s needs.

This trial will be an update to the plan of execution based on review of data, discussions

with former principal investigators from Apimeds Korea.

Upon successful completion and FDA clearance of our Phase III trial in knee OA,

we will be positioned to submit a BLA.

We intend that the purpose of this trial will

be to evaluate the effectiveness of Apitox in the treatment of grade 2, 3 and 4 OA of the knee.

The trial will be designed with a specific

focus on the identified subgroup from which we see the highest degree of benefit.

The following table summarizes the preliminary

clinical trial activity by Apimeds Korea with respect to Apitoxin:

Based on our previous correspondence with the FDA, we have started to design and will implement our Phase III

trial to best address our patient population of patients with grade 2, 3 and 4 knee OA, appropriate dosing, and the most effective way

to evaluate Apitox in meeting a patient’s needs.

This trial will be an update to the plan of execution based on review of data,

discussions with former principal investigators from Apimeds Korea.

Upon successful completion and FDA clearance of our Phase III

trial in knee OA, we will be positioned to submit a BLA.

We intend that the purpose of this trial will be to

evaluate the effectiveness of Apitox in the treatment of grade 2, 3 and 4 OA of the knee.

The trial will be designed with a specific focus

on the identified subgroup from which we see the highest degree of benefit.

The following table summarizes the preliminary clinical

trial activity by Apimeds Korea with respect to Apitoxin:

Preliminary Clinical Data in MS Patients

The United States data from the literature

on bee venom studies in MS patients, Table A (Hauser et al.

The United States data from the literature on

bee venom studies in MS patients, Table A (Hauser et al.

2001) below, showed clinically significant improvements in disability symptoms

following treatment.

In Table A, results were categorized into the

following groups:

In Table A, results were categorized into the following

dramatic disability improvement (>12 points on the Related Observable Symptom Scale (“ROSS”), good improvement

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improvement in disability (dramatic, good or minimal) and 58% demonstrated a marked improvement (dramatic or good).

Summary of Patient Disability

Improvement to Bee Venom Treatment Using ROSS

of Patient Disability Improvement to Bee Venom Treatment Using ROSS

Follow-up Survey

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clinical trial for OA and peer reviewed publications, including those referenced in Table A above and formal Phase I (the “Castro

Phase I Trial”) and Phase II (the “Wesselius Phase II Trial”) publications specific to MS, to support its submission

in 2014 of its Investigational New Drug Application (“IND”) 122804 (A Phase III, Multi-Center, Randomized, Double-Blind,

Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and Quality

of Life in Patients with Multiple Sclerosis).

Phase I Trial”) and Phase II (the “Wesselius Phase II Trial”) publications specific to MS, to support

its submission in 2014 of its Investigational New Drug Application (“IND”) 122804 (A Phase III, Multi-Center, Randomized,

Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Apitox Add-on Therapy for Improving Disability

and Quality of Life in Patients with Multiple Sclerosis).

Castro Phase I Trial

The Castro Phase I Trial involved a total of nine

bee venom nonallergic patients with progressive forms of MS, who were 21–55 years of age with no other illnesses.

The subjects distributed

across four groups (A, B, C, and D) and followed a structured 1-year immunization schedule.

Hyperreactivity to bee venom was evaluated

by questionnaire, physical examination, and a battery of hematologic, metabolic, and immunologic tests.

Responses to therapy were evaluated

by questionnaire, functional neurological tests, and changes in measurement of somatosensory-evoked potentials.

While no serious adverse

allergic reactions were observed in any of the subjects, four experienced worsening of neurological symptoms, requiring their discontinuation

in the study.

The observed negative effects could not be conclusively attributed to adverse reactions arising from the administered therapy.

Of the remaining five subjects, three reported subjective amelioration of symptoms and two exhibited objective improvement.

Despite suggesting

safety in this preliminary study, the small sample size precluded definitive conclusions regarding the efficacy of the treatment for MS.

The Castro Phase I Trial involved a total of

nine bee venom nonallergic patients with progressive forms of MS, who were 21 – 55 years of age with no other illnesses.

The subjects distributed across four groups (A, B, C, and D) and followed a structured 1-year immunization schedule.

Hyperreactivity to

bee venom was evaluated by questionnaire, physical examination, and a battery of hematologic, metabolic, and immunologic tests.

to therapy were evaluated by questionnaire, functional neurological tests, and changes in measurement of somatosensory-evoked potentials.

While no serious adverse allergic reactions were observed in any of the subjects, four experienced worsening of neurological symptoms,

requiring their discontinuation in the study.

The observed negative effects could not be conclusively attributed to adverse reactions

arising from the administered therapy.

Of the remaining five subjects, three reported subjective amelioration of symptoms and two exhibited

objective improvement.

Despite suggesting safety in this preliminary study, the small sample size precluded definitive conclusions regarding

the efficacy of the treatment for MS.

Larger and more carefully conducted multicenter studies were required to establish efficacy.

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crossover study of 26 patients diagnosed with relapsing-remitting or relapsing secondary progressive MS.

Participants were assigned to

24 weeks of medically supervised bee sting therapy, or a control period of 24 weeks of no treatment.

Live bees (up to a maximum of 20)

were used to administer bee venom three times per week.

The primary outcome was the cumulative number of new gadolinium-enhancing lesions

on T1-weighted MRI of the brain.

Participants were assigned

to 24 weeks of medically supervised bee sting therapy, or a control period of 24 weeks of no treatment.

Live bees (up to a maximum

of 20) were used to administer bee venom three times per week.

The primary outcome was the cumulative number of new gadolinium-enhancing

lesions on T1-weighted MRI of the brain.

Secondary outcomes were lesion load on T2*-weighted MRI, relapse rate, disability (Expanded Disability

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Fatigue Impact Scale), and health-related quality of life (Medical Outcomes Study 36-Item Short Form General Health Survey).

of the Wesselous Phase II Trial indicated that during bee sting therapy, there was no significant reduction in the cumulative number of

new gadolinium-enhancing lesions.

The T2*-weighted lesion load further progressed, and there was no significant reduction in relapse rate.

The results of the Wesselous Phase II Trial indicated that during bee sting therapy, there was no significant reduction in the cumulative

number of new gadolinium-enhancing lesions.

The T2*-weighted lesion load further progressed, and there was no significant reduction in

relapse rate.

There was no improvement of disability, fatigue, and quality of life.

Bee sting therapy was well tolerated, and there were no serious

adverse events.

In this trial, treatment with bee venom in patients with relapsing multiple sclerosis did not reduce disease activity,

disability, or fatigue and did not improve quality of life measured using gadolinium-enhancing MRI.

From June 2014 to June 2018, Apimeds

Korea corresponded with the FDA and there were no clinical holds at that time.

Sponsorship of IND 122804 was transferred from Apimeds

Korea to us in October 2020.

Bee sting therapy was well tolerated, and there were

no serious adverse events.

In this trial, treatment with bee venom in patients with relapsing multiple sclerosis did not reduce disease

activity, disability, or fatigue and did not improve quality of life measured using gadolinium-enhancing MRI.

From June 2014 to June 2018, Apimeds Korea

corresponded with the FDA and there were no clinical holds at that time.

Sponsorship of IND 122804 was transferred from Apimeds Korea

to us in October 2020.

On September 21, 2021, we responded to customary non-clinical hold comments from the FDA.

November 2021, we received a customary clinical hold from the FDA due to the retirement of the former principal investigator.

have subsequently updated the FDA with a new principal investigator via our Chief Medical Officer, Dr.

In November 2021,

we received a customary clinical hold from the FDA due to the retirement of the former principal investigator.

We have subsequently updated

the FDA with a new principal investigator via our Chief Medical Officer, Dr.

Christopher Kim.

2023, the FDA removed the clinical hold and concluded it may be initiated.

We have subsequently made the strategic decision to focus our

efforts and capital on our Phase III trial in knee OA, and instead focus our MS efforts on the early prosecution of appropriate MS patient

populations through non-registered corporate sponsorship studies.

In February 2023, the FDA removed

the clinical hold and concluded it may be initiated.

We have subsequently made the strategic decision to focus our efforts and capital

on our Phase III trial in knee OA, and instead focus our MS efforts on the early prosecution of appropriate MS patient populations

through non-registered corporate sponsorship studies.

Our Commercialization Strategy

We are dedicated to the effective implementation

of regulatory, clinical and legal strategies to create value in Apitox.

We are dedicated to the effective implementation of

regulatory, clinical and legal strategies to create value in Apitox.

The effective execution of this strategy will provide us the opportunity

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Manufacturing

We intend to continue to engage a third-party

manufacturer, Piramal Pharma Solutions, in Lexington, Kentucky to support our Phase III trial and, if Apitox is approved by the FDA,

commercial manufacturing.

This manufacturer has dedicated experience in development and technology transfer of sterile dose formulations,

including liquid and lyophilized formulations.

We intend to continue to engage a third-party manufacturer,

Piramal Pharma Solutions, in Lexington, Kentucky to support our Phase III trial and, if Apitox is approved by the FDA, commercial

manufacturing.

This manufacturer has dedicated experience in development and technology transfer of sterile dose formulations, including

liquid and lyophilized formulations.

Research and Development

We are currently engaged exclusively in the clinical

development of Apitox for continued use in knee OA through a Phase III trial in knee OA and potential use for MS through the early prosecution

of appropriate patient populations through non-registered corporate sponsorship studies.

development of Apitox for continued use in knee OA through a Phase III trial in knee OA and potential use for MS through the early

prosecution of appropriate patient populations through non-registered corporate sponsorship studies.

Sales and Marketing

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Each of these providers represents a potential customer for Apitox.

Apitoxin, which will be known as Apitox in the

United States, has established technological credibility through its preclinical testing, Phase I, Phase II and preliminary

Phase III clinical studies completed by Apimeds Korea.

Apimeds Korea received regulatory approval for Apitoxin by the MFDA in South

Korea, as well as long-term safety data from treatment of patients in Korea from 2003 to 2009.

There were no serious adverse events from

over 3,000 patients monitored, and Apitoxin has been approved and marketed in South Korea for OA since 2003.

We update the FDA annually

on safety data generated by Apimeds Korea from South Korea.

We aim to obtain FDA approval for Apitox in the

United States market for treatment of inflammation and pain management symptoms associated with knee OA, and eventually MS, and expand

the indication portfolio in the autoimmune market with a strategic marketing partner.

The marketing partner strategy is common in the

pharmaceutical marketplace, as the infrastructure, overhead, and barriers to entry dilute the focus and can rapidly erode the financial

well-being of small, product development-based companies such as us.

By identifying the strategic marketing partner at an early stage,

the companies can deliver a final product, or family of products, in a form factor or variety of form factors over time, that specifically

suit the target market.

We believe that Apitox represents a significant opportunity as a platform technology, with numerous product-line

extensions, and the potential for new, ancillary products such as delivery devices.

Apitoxin, which will be known as Apitox in the United States,

has established technological credibility through its preclinical testing, Phase I, Phase II and preliminary Phase III

clinical studies completed by Apimeds Korea.

Apimeds Korea received regulatory approval for Apitoxin by the MFDA in South Korea, as well

as long-term safety data from treatment of patients in Korea from 2003 to 2009.

There were no serious adverse events from over 3,000 patients

monitored, and Apitoxin has been approved and marketed in South Korea for OA since 2003.

We update the FDA annually on safety data generated

by Apimeds Korea from South Korea.

We aim to obtain FDA approval for Apitox in the United States

market for treatment of inflammation and pain management symptoms associated with knee OA, and eventually MS, and expand the indication

portfolio in the autoimmune market with a strategic marketing partner.

The marketing partner strategy is common in the pharmaceutical

marketplace, as the infrastructure, overhead, and barriers to entry dilute the focus and can rapidly erode the financial well-being of

small, product development-based companies such as us.

By identifying the strategic marketing partner at an early stage, the companies

can deliver a final product, or family of products, in a form factor or variety of form factors over time, that specifically suit the

target market.

We believe that Apitox represents a significant opportunity as a platform technology, with numerous product-line extensions,

and the potential for new, ancillary products such as delivery devices.

Reimbursement Strategy

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codes are issued by CMS on a rolling quarterly basis.

We will engage third party contractors to assist

the us with reimbursement, coding and policy development prior to, during and at the time of approval of Apitox.

We will engage third party contractors to assist the

us with reimbursement, coding and policy development prior to, during and at the time of approval of Apitox.

We will look for a contractor

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leading to launch),

● Coding/access implications prior to code assignment (e.g.,

NOC/miscellaneous codes), review the merits/risks of Q-code.

● coding/access implications prior to code assignment (e.g., NOC/miscellaneous

codes), review the merits/risks of Q-code,

● further review the application processes, expectations, case

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with payers and CMS,

● Review of reimbursement implications;

● review of reimbursement implications, and

● methodologies (ASP, WAC, AWP), role of sequestration, 340B,

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of many age-associated diseases.

Many of our competitors, either alone or with

strategic partners, have substantially greater financial, technical, and human resources than we do.

Accordingly, our competitors may

be more successful in obtaining approval for treatments and achieving widespread market acceptance, rendering our treatments obsolete

or non-competitive.

Accelerated merger and acquisition activity in the biotechnology and biopharmaceutical industries may result

in even more resources concentrated among a smaller number of our competitors.

These companies also compete with us in recruiting and

retaining qualified scientific and management personnel, establishing clinical study sites, patient registration for clinical studies,

and acquiring technologies complementary to, or necessary for, our programs.

Smaller or early-stage companies may also prove to be significant

competitors, particularly through collaborative arrangements with large and established companies.

Our commercial opportunity could be

substantially limited in the event that our competitors develop and commercialize products that are more effective, safer, more tolerable,

more convenient, or less expensive than our comparable products.

In geographies that are critical to our commercial success, competitors

may also obtain regulatory approvals before us, resulting in our competitors building a strong market position in advance of our products’

We believe the factors determining the success of our programs will be the efficacy, safety, and convenience of our drug candidates.

Additionally, consumer preference for branded,

generic or private label products sold by competitors could adversely impact our financial performance.

Our competitors, which differ

within individual geographic markets, include large-scale retailers, smaller high-growth companies (which often operate on a regional

basis and offer aggressive competition), multinational corporations moving into or expanding their presence in the consumer healthcare

market, and “private-label” products sold by retailers.

Many of our competitors, either alone or with strategic

partners, have substantially greater financial, technical, and human resources than we do.

Accordingly, our competitors may be more successful

in obtaining approval for treatments and achieving widespread market acceptance, rendering our treatments obsolete or non-competitive.

merger and acquisition activity in the biotechnology and biopharmaceutical industries may result in even more resources concentrated among

a smaller number of our competitors.

These companies also compete with us in recruiting and retaining qualified scientific and management

personnel, establishing clinical study sites, patient registration for clinical studies, and acquiring technologies complementary to,

or necessary for, our programs.

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative

arrangements with large and established companies.

Our commercial opportunity could be substantially limited in the event that our competitors

develop and commercialize products that are more effective, safer, more tolerable, more convenient, or less expensive than our comparable

In geographies that are critical to our commercial success, competitors may also obtain regulatory approvals before us, resulting

in our competitors building a strong market position in advance of our products’ entry.

We believe the factors determining the success

of our programs will be the efficacy, safety, and convenience of our drug candidates.

Additionally, consumer preference for branded, generic

or private label products sold by competitors could adversely impact our financial performance.

Our competitors, which differ within individual

geographic markets, include large-scale retailers, smaller high-growth companies (which often operate on a regional basis and offer aggressive

competition), multinational corporations moving into or expanding their presence in the consumer healthcare market, and “private-label”

products sold by retailers.

Our aim is to reduce the use of NSAIDS and opioid

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process of manufacturing Apitox.

We purchase venom from our United States

supplier, Apico, Inc.

We purchase venom from our United States supplier,

(“Apico”), via a letter agreement.

Pursuant to the letter agreement, Apico agreed that for a period

of ten years, or until November 3, 2031 it would not supply Apis Mellifea venom for pharmaceutical use for any buyer

other than us;

Pursuant to the letter agreement, Apico agreed that for a period of ten years,

or until November 3, 2031 it would not supply Apis Mellifea venom for pharmaceutical use for any buyer other than

provided that Apico may also supply Apimeds Korea for its use outside of the United States.

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terminated upon mutual written consent of both Apico and the Company.

Apico has developed and practices a proprietary

method of harvesting venom.

It operates under and is certified in current good manufacturing practice regulations enforced by the FDA

and has an active and current Drug Master File (“DMF”) with the FDA.

DMF’s are submissions to the FDA used to provide

confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing

of human drug products.

We have an exclusive relationship with our supplier for pharmaceutical use in the United States and they

are not permitted to sell to any other party for pharmaceutical use.

Apico has developed and practices a proprietary method

of harvesting venom.

It operates under and is certified in current good manufacturing practice regulations enforced by the FDA and has

an active and current Drug Master File (“DMF”) with the FDA.

DMF’s are submissions to the FDA used to provide confidential,

detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug

We have an exclusive relationship with our supplier for pharmaceutical use in the United States and they are not permitted

to sell to any other party for pharmaceutical use.

Apimeds Korea has a number of proprietary analytical

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developed and practiced for the commercial manufacturing of Apitoxin include dilution, filtering, vial staging and lyophilization parameters

We plan to file Apitox as a BLA with the Centers

for Biologics and Research of the FDA following the successful completion of our Phase III trial for knee OA.

We plan to file Apitox as a BLA with the Centers for

Biologics and Research of the FDA following the successful completion of our Phase III trial for knee OA.

The FDA provides 12-year

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Government Regulation and Product Approval

In the United States, biological products

are subject to regulation under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), and the Public Health Service Act (the

In the United States, biological products are

subject to regulation under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), and the Public Health Service Act (the

“PHSA”), and other federal, state, and local statutes and regulations.

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the expenditure of substantial time and financial resources.

Government policies may change, and additional

government regulations may be enacted that could prevent or delay further development or regulatory approval of any product candidates,

product or manufacturing changes, additional disease indications or label changes.

We cannot predict the likelihood, nature or extent

of government regulation that might arise from future legislative or administrative action.

Government policies may change, and additional government

regulations may be enacted that could prevent or delay further development or regulatory approval of any product candidates, product or

manufacturing changes, additional disease indications or label changes.

We cannot predict the likelihood, nature or extent of government

regulation that might arise from future legislative or administrative action.

Review and Approval for Licensing Biologics

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in accordance with FDA’s good laboratory practice (“GLP”) regulations;

● manufacture, labeling and distribution of investigational

drugs in compliance with FDA’s current good manufacturing practice (“cGMP”) requirements;

● manufacture, labeling and distribution of investigational drugs

in compliance with FDA’s current good manufacturing practice (“cGMP”) requirements;

● submission to FDA of an investigational new drug application

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for each clinical site before each clinical trial may be initiated;

● performance of adequate and well-controlled human clinical

trials in accordance with FDA’s Good Clinical Practices (“GCP”) to establish the safety, purity, and potency of the

proposed biological product candidate for its intended purpose;

● performance of adequate and well-controlled human clinical trials

in accordance with FDA’s Good Clinical Practices (“GCP”) to establish the safety, purity, and potency of the proposed

biological product candidate for its intended purpose;

● after completion of all pivotal clinical trials, preparation

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when appropriate, as may be requested by FDA to assist with its review;

● satisfactory completion of one or more FDA inspections of

the manufacturing facility or facilities at which the proposed product, or certain components thereof, are produced to assess compliance

● satisfactory completion of one or more FDA inspections of the

manufacturing facility or facilities at which the proposed product, or certain components thereof, are produced to assess compliance

with cGMP and data integrity requirements to assure that the facilities, methods, and controls are adequate to preserve the biological

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investigation sites to assure compliance with GCP requirements and the integrity of the clinical data;

● satisfactory completion of an FDA sponsor GCP inspection,

often conducted at the applicant’s headquarters facility;

● payment of user fees (unless there is a waiver, exemption,

or reduction) under the Prescription Drug User Fee Act (“PDUFA”) for the relevant year;

● satisfactory completion of an FDA sponsor GCP inspection, often

conducted at the applicant’s headquarters facility;

● payment of user fees (unless there is a waiver, exemption, or

reduction) under the Prescription Drug User Fee Act (“PDUFA”) for the relevant year;

● FDA’s review and approval of the BLA to permit commercial

marketing of the licensed biologic for particular indications for use in the United States;

● compliance with post-approval requirements, including the

potential requirements to implement a risk evaluation and mitigation strategy (“REMS”), to report adverse events and biological

product deviations, and to complete any post-approval studies;

● completion of any post-approval clinical studies required

by FDA, such as confirmatory trials or pediatric studies.

● compliance with post-approval requirements, including the potential

requirements to implement a risk evaluation and mitigation strategy (“REMS”), to report adverse events and biological product

deviations, and to complete any post-approval studies;

● completion of any post-approval clinical studies required by

FDA, such as confirmatory trials or pediatric studies.

From time to time, legislation is drafted, introduced,

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submitted to FDA as part of an IND.

An IND is a request for authorization from FDA

to administer an investigational new drug product to humans.

An IND is an exemption from the FDCA that allows an unapproved drug to be

shipped in interstate commerce for use in a clinical trial.

An IND is a request for authorization from FDA to

administer an investigational new drug product to humans.

An IND is an exemption from the FDCA that allows an unapproved drug to be shipped

in interstate commerce for use in a clinical trial.

Such authorization must be secured prior to interstate shipment and administration

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development and for any subsequent protocol amendments.

Human clinical trials may not begin until an IND

is effective.

The IND automatically becomes effective 30 days after receipt by FDA, unless FDA raises safety concerns or questions

about the proposed clinical trial within the 30-day time period.

Human clinical trials may not begin until an IND is

The IND automatically becomes effective 30 days after receipt by FDA, unless FDA raises safety concerns or questions about

the proposed clinical trial within the 30-day time period.

In such a case, FDA may place the IND on clinical hold and the IND sponsor

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may or may not result in regulatory authorization to begin a clinical trial.

FDA may also place a clinical hold or partial

clinical hold on a clinical trial following commencement of the trial under an IND.

A clinical hold is an order issued by FDA to

the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation.

A partial clinical hold is a delay or suspension

of only part of the clinical work requested under the IND.

For example, under a partial clinical hold, FDA may instruct a sponsor

not to enroll any new patients into a study but permit the previously enrolled patients to continue in the study.

FDA may also place a clinical hold or partial clinical

hold on a clinical trial following commencement of the trial under an IND.

A clinical hold is an order issued by FDA to the sponsor

to delay a proposed clinical investigation or to suspend an ongoing investigation.

A partial clinical hold is a delay or suspension of

only part of the clinical work requested under the IND.

For example, under a partial clinical hold, FDA may instruct a sponsor not

to enroll any new patients into a study but permit the previously enrolled patients to continue in the study.

No more than 30 days

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previously cited or otherwise satisfying FDA that the investigation can proceed.

Clinical trials involve the administration of

the investigational product to human subjects under the supervision of qualified investigators in accordance with GCP regulations, which

include the requirement that all research subjects provide their informed consent for their participation in any clinical trial.

sponsor chooses to conduct a foreign clinical study under an IND, all FDA IND requirements must be met unless waived.

When the foreign

clinical study is not conducted under an IND, the sponsor must ensure that the study complies with GCP regulations in order to use the

study as support for an IND or application for marketing approval, including review and approval by an IRB and informed consent from subjects.

Furthermore, an independent IRB for all sites

participating in a clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical

trial begins at each site and must monitor the trial until completed.

Regulatory authorities, the IRB, or the sponsor may suspend a clinical

trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the

trial is unlikely to meet its stated objectives.

Clinical trials involve the administration of the

investigational product to human subjects under the supervision of qualified investigators in accordance with GCP regulations, which include

the requirement that all research subjects provide their informed consent for their participation in any clinical trial.

chooses to conduct a foreign clinical study under an IND, all FDA IND requirements must be met unless waived.

When the foreign clinical

study is not conducted under an IND, the sponsor must ensure that the study complies with GCP regulations in order to use the study as

support for an IND or application for marketing approval, including review and approval by an IRB and informed consent from subjects.

Furthermore, an independent IRB for all sites participating

in a clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins

at each site and must monitor the trial until completed.

Regulatory authorities, the IRB, or the sponsor may suspend a clinical trial

at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial

is unlikely to meet its stated objectives.

Some trials also include oversight by an independent

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modify or stop the trial.

Other grounds for a sponsor’s decision to

suspend or terminate a study may be made based on evolving business objectives or the competitive climate.

For purposes of BLA approval, clinical trials

are typically conducted in the following sequential phases:

The investigational product is initially introduced into a small group of

healthy human subjects or patients with the target disease or condition.

These trials are designed to test the safety, dosage

tolerance, absorption, metabolism and distribution of the investigational product in humans and the side effects associated with

increasing doses.

Other grounds for a sponsor’s decision to suspend

or terminate a study may be made based on evolving business objectives or the competitive climate.

For purposes of BLA approval, clinical trials are

typically conducted in the following sequential phases:

The investigational

product is initially introduced into a small group of healthy human subjects or patients with the target disease or condition.

trials are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans

and the side effects associated with increasing doses.

These trials may also yield early evidence of effectiveness.

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These phases may overlap or be combined.

cases, FDA may require, or companies may voluntarily pursue, additional clinical trials after a product are approved to gain more information

In some cases,

FDA may require, or companies may voluntarily pursue, additional clinical trials after a product are approved to gain more information

about the product, referred to as Phase 4 trials.

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additional data and information relating to the use of the product in new indications.

Progress reports detailing the results of the

clinical trials must be submitted at least annually to FDA.

In addition, IND safety reports must be submitted to FDA for any of the

Progress reports detailing the results of the clinical

trials must be submitted at least annually to FDA.

In addition, IND safety reports must be submitted to FDA for any of the following:

serious and unexpected suspected adverse reactions in study subjects;

findings from epidemiological studies, pooled analysis

of multiple studies, animal or in vitro testing, or other clinical studies, whether or not conducted under an IND, and whether or not

conducted by the sponsor, that suggest a significant risk in humans exposed to the drug;

and any clinically important increase in the

rate of a serious suspected adverse reaction over such rate listed in the protocol or investigator brochure.

A sponsor’s planned clinical trials may

not be completed successfully within any specified period, or at all.

findings from epidemiological studies, pooled analysis of multiple

studies, animal or in vitro testing, or other clinical studies, whether or not conducted under an IND, and whether or not conducted by

the sponsor, that suggest a significant risk in humans exposed to the drug;

and any clinically important increase in the rate of a serious

suspected adverse reaction over such rate listed in the protocol or investigator brochure.

A sponsor’s planned clinical trials may not

be completed successfully within any specified period, or at all.

Furthermore, the FDA or the sponsor may suspend or terminate a clinical

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data submitted.

During clinical development, the sponsor often

refines the indication and endpoints on which the BLA will be based.

For endpoints based on patient-reported outcomes (“PROs”),

the process typically is an iterative one.

During clinical development, the sponsor often refines

the indication and endpoints on which the BLA will be based.

For endpoints based on patient-reported outcomes (“PROs”), the

process typically is an iterative one.

FDA has issued guidance on the framework it uses to evaluate PRO instruments.

agency may offer advice on optimizing PRO instruments during the clinical development process, FDA usually reserves final judgment until

it reviews the BLA.

Concurrent with clinical trials, companies often

complete additional animal studies, and develop additional information about the chemistry and physical characteristics of the drug and

finalize a process for manufacturing the product in commercial quantities in accordance with cGMP.

The manufacturing process must

be capable of consistently producing quality batches of the drug candidate and, among other things, must develop methods for testing the

identity, strength, quality, purity and potency of the final drug.

Additionally, appropriate packaging must be selected and tested, and

stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over its shelf

Although the agency

may offer advice on optimizing PRO instruments during the clinical development process, FDA usually reserves final judgment until it reviews

Concurrent with clinical trials, companies often complete

additional animal studies, and develop additional information about the chemistry and physical characteristics of the drug and finalize

a process for manufacturing the product in commercial quantities in accordance with cGMP.

The manufacturing process must be capable

of consistently producing quality batches of the drug candidate and, among other things, must develop methods for testing the identity,

strength, quality, purity and potency of the final drug.

Additionally, appropriate packaging must be selected and tested, and stability

studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over its shelf life.

BLA Submission and Review

Assuming successful completion of all required

clinical testing in accordance with all applicable regulatory requirements, an applicant may submit a BLA requesting licensing to market

the biologic for one or more indications in the United States.

The BLA must include the results of nonclinical studies and clinical

detailed information on the product’s chemistry, manufacture, controls;

Assuming successful completion of all required clinical

testing in accordance with all applicable regulatory requirements, an applicant may submit a BLA requesting licensing to market the biologic

for one or more indications in the United States.

The BLA must include the results of nonclinical studies and clinical trials;

information on the product’s chemistry, manufacture, controls;

and proposed labeling.

Under the PDUFA, a BLA submission

is subject to an application user fee, unless a waiver, reduction, or exemption applies.

Under the PDUFA, a BLA submission is subject

to an application user fee, unless a waiver, reduction, or exemption applies.

FDA will initially review the BLA for completeness

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is an important component of the sponsor’s responsibility to ensure the safety, efficacy and quality of its product or products.

For cellular products, FDA will not approve the

product if the manufacturer is not in compliance with the GTPs, to the extent applicable.

GTPs are FDA regulations and guidance documents

that govern the methods used in, and the facilities and controls used for, the manufacture of human cells, tissue, and cellular and tissue-based

For cellular products, FDA will not approve the product

if the manufacturer is not in compliance with the GTPs, to the extent applicable.

GTPs are FDA regulations and guidance documents that

govern the methods used in, and the facilities and controls used for, the manufacture of human cells, tissue, and cellular and tissue-based

products (“HCT/Ps”), which are human cells or tissue intended for implantation, transplant, infusion, or transfer into a human

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does not satisfy the regulatory criteria for approval.

The performance goals and policies implemented

by FDA under the PDUFA generally provide for FDA action on an original BLA within 10 months of filing, which (as discussed above)

typically occurs within 60 days of submission, but that deadline is extended in certain circumstances.

Furthermore, the review process

is often significantly extended by FDA’s requests for additional information or clarification.

FDA may refer applications for novel products

or products that present difficult questions of safety or efficacy to an advisory committee.

Typically, an advisory committee consists

of a panel that includes clinicians and other experts who will review, evaluate, and provide a recommendation as to whether the application

should be approved and, if so, under what conditions.

The performance goals and policies implemented by

FDA under the PDUFA generally provide for FDA action on an original BLA within 10 months of filing, which (as discussed above) typically

occurs within 60 days of submission, but that deadline is extended in certain circumstances.

Furthermore, the review process is often

significantly extended by FDA’s requests for additional information or clarification.

FDA may refer applications for novel products or products

that present difficult questions of safety or efficacy to an advisory committee.

Typically, an advisory committee consists of a panel

that includes clinicians and other experts who will review, evaluate, and provide a recommendation as to whether the application should

be approved and, if so, under what conditions.

The FDA is not bound by the recommendations of an advisory committee, but it considers

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may decide that the application does not satisfy the regulatory criteria for approval.

During the approval process, FDA will determine

whether a REMS is necessary to help ensure the benefits outweigh the risks of the biologic.

A REMS is a safety strategy to manage a known

or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their

safe use, and could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution

methods, patient registries and other risk minimization tools.

If FDA concludes that a REMS is needed, the BLA sponsor must submit a proposed

REMS and FDA will not approve the BLA without a REMS that the agency has determined is acceptable.

If the FDA approves a product, it may limit the

approved indications for use for the product, or require that contraindications, warnings, or precautions be included in the product labeling.

During the approval process, FDA will determine whether

a REMS is necessary to help ensure the benefits outweigh the risks of the biologic.

A REMS is a safety strategy to manage a known or potential

serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use, and

could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods,

patient registries and other risk minimization tools.

If FDA concludes that a REMS is needed, the BLA sponsor must submit a proposed REMS

and FDA will not approve the BLA without a REMS that the agency has determined is acceptable.

If the FDA approves a product, it may limit the approved

indications for use for the product, or require that contraindications, warnings, or precautions be included in the product labeling.

FDA may also require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess the drug’s

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FDA may prevent or limit further marketing of a product based on the results of post-market studies or surveillance

FDA may also require testing and surveillance

programs to monitor the product after commercialization.

For biologics, such testing may include official lot release, which requires

the manufacturer to perform certain tests on each lot of the product before it is released for distribution.

The manufacturer then typically

must submit samples of each lot of products to the FDA, together with a release protocol showing a summary of the history of manufacture

of the lot and the results of all of the manufacturer’s tests performed on the lot.

The FDA may also perform certain confirmatory

tests on lots of some products itself, before releasing the lots for distribution by the manufacturer.

FDA may also require testing and surveillance programs

to monitor the product after commercialization.

For biologics, such testing may include official lot release, which requires the manufacturer

to perform certain tests on each lot of the product before it is released for distribution.

The manufacturer then typically must submit

samples of each lot of products to the FDA, together with a release protocol showing a summary of the history of manufacture of the lot

and the results of all of the manufacturer’s tests performed on the lot.

The FDA may also perform certain confirmatory tests on

lots of some products itself, before releasing the lots for distribution by the manufacturer.

In general, an approved BLA only allows the sponsor

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and quality control to maintain compliance with cGMP, data integrity, pharmacovigilance, and other aspects of regulatory compliance.

The FDA may withdraw the approval if compliance

with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.

Later discovery

of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing

processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information;

imposition of post-approval studies to assess new safety risks;

The FDA may withdraw the approval if compliance with

regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.

Later discovery of

previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes,

or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information;

of post-approval studies to assess new safety risks;

or imposition of distribution or other restrictions under a REMS.

potential consequences include, for example:

Other potential

consequences include, for example:

● restrictions on the marketing or manufacturing of a product,

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to approved applications, or suspension or revocation of existing product approvals;

● product seizure or detention, or refusal of FDA to permit

the import or export of products;

● permanent injunctions and consent decrees, including the

imposition of civil or criminal penalties.

FDA strictly regulates the marketing, labeling,

advertising, and promotion of prescription drug products placed on the market.

A company can make only those claims relating to safety

and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved labeling.

regulation includes, among other things, standards and regulations for direct-to-consumer advertising, communications regarding unapproved

uses, industry-sponsored scientific and educational activities and promotional activities involving the Internet and social media.

● product seizure or detention, or refusal of FDA to permit the

import or export of products;

● permanent injunctions and consent decrees, including the imposition

of civil or criminal penalties.

FDA strictly regulates the marketing, labeling, advertising,

and promotion of prescription drug products placed on the market.

A company can make only those claims relating to safety and efficacy,

purity and potency that are approved by the FDA and in accordance with the provisions of the approved labeling.

FDA’s regulation

includes, among other things, standards and regulations for direct-to-consumer advertising, communications regarding unapproved uses,

industry-sponsored scientific and educational activities and promotional activities involving the Internet and social media.

claims relating to a product’s safety or effectiveness are prohibited before the drug is approved.

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journal information.

If a company is found to have promoted off-label

uses, it may become subject to adverse public relations and administrative and judicial enforcement by FDA, the DOJ, or the Office of

the Inspector General of the Department of Health and Human Services (“HHS”), as well as other federal and state authorities.

This could subject a company to a range of penalties that could have a significant commercial impact, including civil, administrative,

and criminal fines, penalties, and agreements that materially restrict the manner in which a company promotes or distributes products.

The federal government has levied large civil, administrative, and criminal fines and penalties against companies for alleged improper

promotion and has also requested that companies enter into Corporate Integrity Agreements and Consent Decrees of Permanent Injunction

under which specified promotional conduct is changed or curtailed.

If a company is found to have promoted off-label uses,

it may become subject to adverse public relations and administrative and judicial enforcement by FDA, the DOJ, or the Office of the Inspector

General of the Department of Health and Human Services (“HHS”), as well as other federal and state authorities.

subject a company to a range of penalties that could have a significant commercial impact, including civil, administrative, and criminal

fines, penalties, and agreements that materially restrict the manner in which a company promotes or distributes products.

government has levied large civil, administrative, and criminal fines and penalties against companies for alleged improper promotion and

has also requested that companies enter into Corporate Integrity Agreements and Consent Decrees of Permanent Injunction under which specified

promotional conduct is changed or curtailed.

The distribution of prescription drugs and biologics

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Expedited Development and Review Programs

FDA offers a number of expedited development and

review programs for qualifying product candidates.

The fast-track program is intended to expedite or facilitate the process of reviewing

new products that meet certain criteria.

FDA offers a number of expedited development and review

programs for qualifying product candidates.

The fast-track program is intended to expedite or facilitate the process of reviewing new

products that meet certain criteria.

Specifically, new products are eligible for fast-track designation if they are intended to treat

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Biosimilars and Marketing Exclusivities

The Biologics Price Competition and Innovation

Act (“BPCIA”) created an abbreviated approval pathway for biological product candidates shown to be highly similar to or interchangeable

The Biologics Price Competition and Innovation Act

(“BPCIA”) created an abbreviated approval pathway for biological product candidates shown to be highly similar to or interchangeable

with an FDA licensed biological product.

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of the abbreviated approval pathway that are still being resolved by FDA.

A reference biologic is granted 12 years

of exclusivity from the time of first licensure of the reference product, and no application for a biosimilar can be submitted for four years

from the date of licensure of the reference product.

A reference biologic is granted 12 years of exclusivity

from the time of first licensure of the reference product, and no application for a biosimilar can be submitted for four years from

the date of licensure of the reference product.

The first biological product candidate submitted under the abbreviated approval pathway

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Coverage, Pricing, and Reimbursement

Our ability to successfully commercialize any

products for which we receive regulatory approval for commercial sale will depend, in part, on the extent to which third-party payors

provide coverage and establish adequate reimbursement levels for such products, and significant uncertainty exists as to the coverage

and reimbursement status of any products for which may we obtain regulatory approval.

In the United States, third-party payors include

federal and state health care programs, private managed care providers, health insurers and other organizations.

The process for determining

whether a third-party payor will provide coverage for a product may be separate from the process for setting the price of a product or

for establishing the reimbursement rate that such a payor will pay for the product.

Third-party payors may limit coverage to specific

products on an approved list, also known as a formulary, which might not include all of the FDA-approved products for a particular indication.

Third-party payors are increasingly challenging the price, examining the medical necessity, and reviewing the cost-effectiveness of medical

products, therapies, and services, in addition to questioning their safety and efficacy.

We may need to conduct expensive pharmaco-economic

studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain

the FDA approvals.

Our ability to successfully commercialize any products

for which we receive regulatory approval for commercial sale will depend, in part, on the extent to which third-party payors provide coverage

and establish adequate reimbursement levels for such products, and significant uncertainty exists as to the coverage and reimbursement

status of any products for which may we obtain regulatory approval.

In the United States, third-party payors include federal and

state health care programs, private managed care providers, health insurers and other organizations.

The process for determining whether

a third-party payor will provide coverage for a product may be separate from the process for setting the price of a product or for establishing

the reimbursement rate that such a payor will pay for the product.

Third-party payors may limit coverage to specific products on an approved

list, also known as a formulary, which might not include all of the FDA-approved products for a particular indication.

Third-party payors

are increasingly challenging the price, examining the medical necessity, and reviewing the cost-effectiveness of medical products, therapies,

and services, in addition to questioning their safety and efficacy.

We may need to conduct expensive pharmaco-economic studies in order

to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA approvals.

Our product candidates may not be considered medically necessary or cost-effective.

A payor’s decision to provide

coverage for a product does not imply that an adequate reimbursement rate will be approved.

Further, one payor’s determination to

provide coverage for a product does not assure that other payors will also provide coverage for the product.

Adequate third-party reimbursement

may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

The marketability of any product candidates for

which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate

coverage and reimbursement.

In addition, emphasis on managed care in the United States has increased and we expect will continue

to increase the pressure on healthcare pricing.

A payor’s decision to provide coverage for a

product does not imply that an adequate reimbursement rate will be approved.

Further, one payor’s determination to provide coverage

for a product does not assure that other payors will also provide coverage for the product.

Adequate third-party reimbursement may not

be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

The marketability of any product candidates for which

we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage

and reimbursement.

In addition, emphasis on managed care in the United States has increased and we expect will continue to increase

the pressure on healthcare pricing.

Coverage policies and third-party reimbursement rates may change at any time.

favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable

coverage policies and reimbursement rates may be implemented in the future.

Other Healthcare Laws and Compliance

Even if favorable coverage

and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies

and reimbursement rates may be implemented in the future.

Other Healthcare Laws and Compliance Requirements

Although we currently do not have any commercialized

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and exclusion from participation in federal healthcare programs.

Moreover, a claim including items or services

resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil

False Claims Act.

The federal civil False Claims Act prohibits,

among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment

of government funds or knowingly making, using, or causing to be made or used, a false record or statement material to an obligation to

pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay

money to the federal government.

Persons and entities can be held liable under these laws if they are deemed to “cause” the

submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting

a product off-label.

Many pharmaceutical and other healthcare companies have been investigated and have reached substantial financial

settlements with the federal government under the civil False Claims Act for a variety of alleged improper marketing activities, including:

providing free product to customers with the expectation that the customers would bill federal programs for the product;

providing sham

consulting fees, grants, free travel and other benefits to physicians to induce them to prescribe the company’s products;

and inflating

prices reported to private price publication services, which are used to set drug payment rates under government healthcare programs.

Penalties for federal civil False Claims Act violations may include up to three times the actual damages sustained by the government,

plus mandatory civil penalties of between $13,508 and $27,018 for each separate false claim, and the potential for exclusion from participation

in federal healthcare programs.

In addition, although the federal False Claims Act is a civil statute, False Claims Act violations may

also implicate various federal criminal statutes.

The healthcare fraud provisions of the Health

Insurance Portability and Accountability Act (“HIPAA”) prohibit knowingly and willfully executing, or attempting to execute,

a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing

from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully

falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection

with the delivery of or payment for healthcare benefits, items or services.

Like the federal Anti-Kickback Statute, a person or entity

does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

Many states have analogous laws and regulations,

Moreover, a claim including items or services resulting

from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False

The federal civil False Claims Act prohibits, among

other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of

government funds or knowingly making, using, or causing to be made or used, a false record or statement material to an obligation to pay

money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money

to the federal government.

Persons and entities can be held liable under these laws if they are deemed to “cause” the submission

of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product

Many pharmaceutical and other healthcare companies have been investigated and have reached substantial financial settlements

with the federal government under the civil False Claims Act for a variety of alleged improper marketing activities, including:

free product to customers with the expectation that the customers would bill federal programs for the product;

providing sham consulting

fees, grants, free travel and other benefits to physicians to induce them to prescribe the company’s products;

and inflating prices

reported to private price publication services, which are used to set drug payment rates under government healthcare programs.

for federal civil False Claims Act violations may include up to three times the actual damages sustained by the government, plus mandatory

civil penalties of between $13,508 and $27,018 for each separate false claim, and the potential for exclusion from participation in federal

healthcare programs.

In addition, although the federal False Claims Act is a civil statute, False Claims Act violations may also implicate

various federal criminal statutes.

The healthcare fraud provisions of the Health Insurance

Portability and Accountability Act (“HIPAA”) prohibit knowingly and willfully executing, or attempting to execute, a scheme

to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a

healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying,

concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery

of or payment for healthcare benefits, items or services.

Like the federal Anti-Kickback Statute, a person or entity does not need to

have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

Many states have analogous laws and regulations, such

state anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims involving healthcare items

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civil and/or criminal penalties.

federal Physician Payment Sunshine

Act, implemented as the Open Payments Program, requires manufacturers of drugs, devices, biologics, and medical supplies for which payment

federal Physician Payment Sunshine Act,

implemented as the Open Payments Program, requires manufacturers of drugs, devices, biologics, and medical supplies for which payment

is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to

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other practitioners as of 2022), as well as ownership and investment interests held in the company by physicians and their immediate family

Because we intend to commercialize products that

could be reimbursed under a federal health care program and other governmental healthcare programs, we intend to develop a comprehensive

compliance program that establishes internal control to facilitate adherence to the rules and program requirements to which we will or

may become subject.

Although the development and implementation of compliance programs designed to establish internal control and facilitate

compliance can mitigate the risk of investigation, prosecution, and penalties assessed for violations of these laws, the risks cannot

be entirely eliminated.

If our operations are found to be in violation

of any of such laws or any other governmental regulations that apply to us, we may be subject to penalties, including, without limitation,

Because we intend to commercialize products that could

be reimbursed under a federal health care program and other governmental healthcare programs, we intend to develop a comprehensive compliance

program that establishes internal control to facilitate adherence to the rules and program requirements to which we will or may become

Although the development and implementation of compliance programs designed to establish internal control and facilitate compliance

can mitigate the risk of investigation, prosecution, and penalties assessed for violations of these laws, the risks cannot be entirely

If our operations are found to be in violation of

any of such laws or any other governmental regulations that apply to us, we may be subject to penalties, including, without limitation,

administrative, civil and criminal penalties, damages, fines, disgorgement, contractual damages, reputational harm, diminished profits

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programs and individual imprisonment, any of which could adversely affect our ability to operate our business and our financial results.

Health Care Reform

Health Care Reforms

In the United States and some foreign jurisdictions,

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manufacturers to pay rebates on Medicaid managed care utilization and by enlarging the population potentially eligible for Medicaid drug

There have been judicial challenges to certain

aspects of the ACA, as well as efforts by Congress to modify, and by agencies to alter the implementation of, certain aspects of the ACA.

There have been judicial challenges to certain aspects

of the ACA, as well as efforts by Congress to modify, and by agencies to alter the implementation of, certain aspects of the ACA.

example, Congress eliminated the tax penalty for failure to comply with the ACA’s individual mandate to carry health insurance.

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federal health care programs may result in a similar reduction or restriction by private payors.

Other legislative changes have been proposed and

adopted in the U.S.

Other legislative changes have been proposed and adopted

since the ACA was enacted.

For example, the Inflation Reduction Act introduces several changes to the Medicare

Part D benefit, including a limit on annual out-of-pocket costs and a change in manufacturer liability under the program which could

negatively affect the profitability of our product candidates.

The IRA sunsets the current Part D coverage gap discount program starting

in 2025 and replaces it with a new manufacturer discount program.

Failure to pay a discount under this new program will be subject to

a civil monetary penalty.

In addition, the IRA establishes a Medicare Part B inflation rebate scheme effective January 2023

and a Medicare Part D inflation rebate scheme effective October 2022, under which, generally speaking, manufacturers will owe

rebates if the price of a Part B or Part D drug increases faster than the pace of inflation.

Failure to timely pay a Part B

or D inflation rebate is subject to a civil monetary penalty.

The IRA also creates a drug price negotiation program under which the prices

for Medicare units of certain high Medicare spend drugs and biologicals without generic or biosimilar competition will be capped by reference

to, among other things, a specified non-federal average manufacturer price starting in 2026.

Failure to comply with requirements under

the drug price negotiation program is subject to an excise tax and/or a civil monetary penalty.

Congress continues to examine various

policy proposals that may result in pressure on the prices of prescription drugs with respect to the government health benefit programs

and otherwise.

For example, the Inflation Reduction Act introduces several changes to the Medicare Part D

benefit, including a limit on annual out-of-pocket costs and a change in manufacturer liability under the program which could negatively

affect the profitability of our product candidates.

The IRA sunsets the current Part D coverage gap discount program starting in

2025 and replaces it with a new manufacturer discount program.

Failure to pay a discount under this new program will be subject to a civil

monetary penalty.

In addition, the IRA establishes a Medicare Part B inflation rebate scheme effective January 2023 and a Medicare

Part D inflation rebate scheme effective October 2022, under which, generally speaking, manufacturers will owe rebates if the

price of a Part B or Part D drug increases faster than the pace of inflation.

Failure to timely pay a Part B or D inflation

rebate is subject to a civil monetary penalty.

The IRA also creates a drug price negotiation program under which the prices for Medicare

units of certain high Medicare spend drugs and biologicals without generic or biosimilar competition will be capped by reference to, among

other things, a specified non-federal average manufacturer price starting in 2026.

Failure to comply with requirements under the drug

price negotiation program is subject to an excise tax and/or a civil monetary penalty.

Congress continues to examine various policy proposals

that may result in pressure on the prices of prescription drugs with respect to the government health benefit programs and otherwise.

The IRA or other legislative changes could impact the market conditions for our product candidates.

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Drug Pedigree Laws

State and federal governments have proposed or

enacted various drug pedigree laws which can require the tracking of all transactions involving prescription drugs from the manufacturer

to the pharmacy (or other dispensing) level.

Companies are required to maintain records documenting the chain of custody of prescription

drug products beginning with the purchase of such products from the manufacturer.

State and federal governments have proposed or enacted

various drug pedigree laws which can require the tracking of all transactions involving prescription drugs from the manufacturer to the

pharmacy (or other dispensing) level.

Companies are required to maintain records documenting the chain of custody of prescription drug

products beginning with the purchase of such products from the manufacturer.

Compliance with these pedigree laws requires implementation

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to comply could result in fines or penalties, as well as loss of business that could have a material adverse effect on our financial results.

Federal Regulation of Patent Litigation Settlements and Authorized

Generic Arrangements

Federal Regulation of Patent Litigation Settlements

and Authorized Generic Arrangements

As part of the Medicare Prescription Drug, Improvement,

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or proceedings by the FTC or other governmental authorities.

federal government, various states

and localities have laws regulating the manufacture and distribution of pharmaceuticals, as well as regulations dealing with the substitution

federal government, various states and

localities have laws regulating the manufacture and distribution of pharmaceuticals, as well as regulations dealing with the substitution

of generic drugs for branded drugs.

1 unchanged sentence

and localities in which our operations are located or in which we conduct business.

Certain of our activities are also subject to

FTC enforcement actions.

The FTC enforces a variety of antitrust and consumer protection laws designed to ensure that the nation’s

markets function competitively, are vigorous, efficient and free of undue restrictions.

Federal, state, local and foreign laws of general

applicability, such as laws regulating working conditions, also govern us.

Certain of our activities are also subject to FTC

enforcement actions.

The FTC enforces a variety of antitrust and consumer protection laws designed to ensure that the nation’s markets

function competitively, are vigorous, efficient and free of undue restrictions.

Federal, state, local and foreign laws of general applicability,

such as laws regulating working conditions, also govern us.

In addition, we are subject to numerous and increasingly

12 unchanged sentences

impacts from historical operations at sites we have acquired in the past or may acquire in the future.

As of the date of this Annual Report, we have two full time employees.

As of the date of this Annual Report, we have

seven (7) full time employees.

We have no part-time employees and we engage one consultant.

We believe that we maintain good relations with our employees.

As a smaller reporting company, as defined in

Rule 12b-2 of the Exchange Act, we are not required to provide the information required by this Item.

We believe that we maintain good relations

with our employees.

INFORMATION ABOUT THE BUSINESS OF MINDWAVE INNOVATIONS

Unless the context otherwise indicates or requires,

all references in this section to “we,” “us,” “our,” “our company” “the Company”

and “MindWave” refer to MindWave Innovations Inc

MindWave Innovations Inc (“MindWave,”

the “Company,” “we,” “us” or “our”) is a technology platform company focused on institutional

Digital Asset Treasury (“ DAT ”) solutions, centered on enabling corporations and institutions to hold, manage, and generate

yield on Bitcoin reserves through a compliant, scalable infrastructure.

Our strategic model integrates secure digital treasury wallets,

AI-supported Bitcoin yield programs, and a validator-enabled ecosystem supported by our native token, $NILA.

TechyTrade Innovations

is a Singapore exempt private company and wholly owned subsidiary of MindWave Innovations Inc (“ TechyTrade (Singapore) ”).

FZ LLC is a limited liability company operating under the laws of the Ras Al Khaimah Economic Zone is a wholly owned subsidiary of TechyTrade

Singapore (“ TechyTrade (Dubai) ”).

MindWave operates through an international structure that includes TechyTrade (Singapore)

and TechyTrade (Dubai), which contains the primary business operations of MindWave.

Our balance sheet strategy is designed to align with

our DAT offering.

TechyTrade (Dubai) owns or controls 1,000 Bitcoin free of encumbrances, identifiable and segregated within a sub-wallet

architecture created and administered by MindWave Ltd.

for the benefit of TechyTrade (Dubai), with private keys and beneficial ownership

retained by TechyTrade (Dubai).

TechyTrade (Dubai) has no indebtedness other than trade payables, which were less than fifty percent of

cash on hand.

This reserve posture is intended to preserve purchasing power, provide continuous exposure to Bitcoin, and support our yield

infrastructure without requiring asset sales.

We intend to commercialize our principal DAT offerings

for institutional clients, which comprise:

(i) secure corporate Bitcoin treasury infrastructure designed for public-company balance

sheets and institutional controls;

(ii) AI-supported Bitcoin yield strategies intended to deliver risk-managed, programmatic yield

including InsureTech;

and (iii) a validator-enabled ecosystem that supports utility and governance via $NILA across interoperable

verticals, including AdTech engagement platforms and ClimateTech impact systems, as described in our technical materials.

Custody of client

assets is expected to occur through regulated third-party providers and institutional-grade wallet solutions, implemented within a segregation

and control framework consistent with institutional compliance requirements.

Our operating framework is designed around Bitcoin

as the core reserve and risk collateral reference for treasury and yield solutions.

We expect to avoid hybrid collateral models in favor

of a Bitcoin-centric approach that is transparent, simple, and consistent with our treasury and platform design.

Within our ecosystem,

$NILA functions as an economic and governance substrate to activate services, enable staking mechanisms that align incentives, and facilitate

validator economics across our interoperable platforms.

We intend to serve corporate treasuries and institutions

that maintain or plan to maintain Bitcoin reserves and require scalable, compliant DAT capabilities.

We also expect to support high-net-worth

individuals and funds seeking institutional controls for Bitcoin reserve management and programmatic yield.

Consistent with institutional

practices, our anticipated operations emphasize transparency and risk management, including conservative collateralization where relevant

to client programs, real-time risk monitoring, and robust anti-money laundering (AML) and know-your-customer (KYC) processes.

We are pursuing

strategic relationships with financial institutions, placement agents, and digital-asset service providers to support custody, treasury

operations, and capital formation for expansion of our platform.

We believe that our combination of (i) an institutional

Bitcoin reserve posture supported by segregated custody architecture and independent attestation, (ii) AI-enhanced yield strategies

integrated into a controlled DAT stack, and (iii) a validator-enabled ecosystem powered by $NILA positions us to meet emerging institutional

demand for Bitcoin treasury solutions.

In connection with our merger with Apimeds Pharmaceuticals US, Inc., our DAT platform is expected

to be operated within a publicly listed structure, with Apimeds’ biopharmaceutical business continuing within a subsidiary post-closing,

and capital formation initiatives contemplated to support both the DAT platform and biopharmaceutical development.

We believe this structure

enhances our ability to scale client adoption while maintaining regulatory discipline and institutional-grade controls.

General Development of Our Business

MindWave Innovations Inc was incorporated in the State

of Delaware in 2025.

On December 1, 2025, MindWave signed and closed an Agreement and Plan of Merger with Apimeds Pharmaceuticals

(“ Apimeds ”), Apimeds Merger Sub, Inc.

(“ Merger Sub ”), Lokahi Therapeutics, Inc., and Erik

Emerson, pursuant to which Merger Sub merged with and into MindWave, with MindWave surviving as a wholly owned subsidiary of Apimeds (the

Following the Merger, we have focused our development

efforts on scaling an institutional DAT platform.

Consistent with our treasury reserve posture, our group maintains Bitcoin as its core

reserve asset.

As previously mentioned, TechyTrade (Dubai) owns and controls 1,000 Bitcoin, identifiable and segregated in sub-wallets

administered by MindWave Ltd.

Our principal activities consist of:

our institutional DAT stack, including secure corporate Bitcoin treasury infrastructure and AI-supported Bitcoin yield strategies;

(ii) implementing

and attesting to our Bitcoin reserve and segregated custody architecture;

and (iii) forming relationships with regulated custodians,

wallet and validator providers, financial institutions, and placement agents to support custody, risk management, compliance (including

AML/KYC), and capital formation.

We are in the execution stage and are preparing for commercialization of our DAT offerings.

Roadmap and Milestones

Our near-term priorities focus on:

(i) onboarding

initial institutional clients to our corporate Bitcoin treasury infrastructure;

(ii) progressing AI-supported, risk-managed yield

programs under defined policy and control frameworks;

(iii) standing up enterprise validator services to support network participation

and governance;

and (iv) advancing development of our ClimateTech, AdTech, and InsurTech verticals to interoperate with our DAT stack.

Over time, we intend to expand treasury management capabilities, scale validator operations, and develop ecosystem utility, subject to

applicable regulatory requirements, market conditions, and governance approvals.

Our Treasury Strategy and Digital Asset Treasury

Bitcoin Treasury Strategy

We believe that Bitcoin is an attractive

reserve asset because (i) it can serve as a store of value supported by a robust, public, open-source architecture that is independent

of sovereign monetary policy, (ii) its fixed supply offers the potential to serve as a long-term hedge against inflation and, as

adoption increases, the opportunity for appreciation, and (iii) the Bitcoin network provides infrastructure for financial and technological

We were formed with the intention of operating an

institutional-focused Digital Asset Treasury (“DAT”) platform, and our group has adopted a Bitcoin-centric reserve posture aligned

with that platform.

Under this posture, our treasury reserve assets consist principally of:

● Cash and cash equivalents sufficient for working capital

and operational needs;

● Bitcoin held at the operating-subsidiary level as our primary

reserve asset, maintained within a segregated sub-wallet architecture and free of encumbrances, subject to business needs and market

Consistent with this reserve posture, we may from

time to time evaluate capital raising transactions to support platform development, working capital, and expansion of our reserve

We expect future capital allocation decisions to consider market conditions, risk management, regulatory considerations, and

anticipated operating requirements.

Our strategy contemplates that we may (i) periodically rebalance or sell Bitcoin for general

corporate purposes, (ii) utilize our Bitcoin reserve within conservative, risk-managed programs that support our yield and validator

infrastructure, and (iii) evaluate compliant structures to generate programmatic returns consistent with institutional practices

and applicable law.

We also plan to conduct advocacy and educational

initiatives regarding institutional Bitcoin treasury standards, custody segregation, controls, and reporting, including thought leadership

and partnerships intended to support the broader adoption of compliant corporate Bitcoin treasury operations.

DAT Yield and Validator Infrastructure

Our core offerings center on an institutional

DAT stack designed to help corporations and institutions hold, manage, and generate yield on Bitcoin reserves.

Key components include:

● Institutional treasury infrastructure.

wallet architecture with segregation and controls designed to align with public-company balance sheet requirements and institutional

compliance frameworks.

● AI-supported yield programs.

strategies intended to produce programmatic returns on Bitcoin reserves, with governance and monitoring controls suitable for institutional

participants.

● Validator-enabled ecosystem.

that support network economics and governance across our ecosystem, including utility powered by our native token, $NILA.

Client assets, if and when onboarded, are expected

to be held through regulated third-party custodians or institutional-grade wallet solutions within a segregation and control

framework consistent with AML/KYC and other applicable requirements.

We emphasize conservative collateralization (where relevant to client

programs), real-time risk monitoring, and robust compliance processes.

Our Bitcoin Holdings

On March 31, 2025, TechyTrade (Dubai) entered

into an Asset Purchase Agreement with MindWave Ltd., pursuant to which TechyTrade (Dubai) acquired 1,000 bitcoin.

The bitcoin are held

free of encumbrances within a segregated sub-wallet architecture administered by MindWave Ltd.

We did not sell any bitcoin during 2024

Our Industry Overview

Bitcoin Industry

Bitcoin is a digital asset that is issued by and transmitted

through an open-source protocol, known as the Bitcoin protocol, collectively maintained by a peer-to-peer network of decentralized user

This network hosts a public transaction ledger, known as the Bitcoin blockchain, on which bitcoin holdings and all validated transactions

that have ever taken place on the Bitcoin network are recorded.

Balances of bitcoin are stored in individual “wallet” functions,

which associate network public addresses with one or more “private keys” that control the transfer of bitcoin.

blockchain can be updated without any single entity owning or operating the network.

Creation of New Bitcoin and Limits on Supply

The Bitcoin protocol limits the total number of bitcoins

that can be generated over time to 21 million.

As of October 2025, approximately 19.93 million bitcoins have been generated.

New bitcoins are created and allocated by the Bitcoin protocol through a “mining” process that rewards users that validate

transactions in the Bitcoin blockchain.

Validated transactions are added in “blocks” approximately every 10 minutes.

process serves to validate transactions and secure the Bitcoin network.

Mining is a competitive and costly operation that requires a large

amount of computational power to solve complex mathematical algorithms.

This expenditure of computing power is known as “proof of

To incentivize miners to incur the costs of mining

bitcoin, the Bitcoin protocol rewards miners that successfully validate a block of transactions with newly generated bitcoin.

reward for miners that successfully validate a block of transactions is 3.125 bitcoin per mined block.

The mining reward is reduced by

half, which is referred to as a bitcoin halving, after every 210,000 blocks are mined.

This has historically occurred approximately every

The most recent bitcoin halving occurred in April 2024, and the next bitcoin halving is expected to occur sometime

Modifications to the Bitcoin Protocol

Bitcoin is an open-source network that has no central

authority, so no one person can unilaterally make changes to the software that runs the network.

However, there is a core group of developers

that maintains the code for the Bitcoin protocol, and they can propose changes to the source code and release periodic updates and other

Unlike most software that has a central entity that can push updates to users, bitcoin is a peer-to-peer network in which individual

network participants, called nodes, decide whether to upgrade the software and accept the new changes.

As a practical matter, a modification

becomes part of the Bitcoin protocol only if the proposed changes are accepted by participants collectively having more than 50% of the

processing power, known as hash rate, on the network.

If a certain percentage of the nodes reject the changes, then a “fork”

takes place, and participants can choose the version of the software they want to run.

Forms of Attack Against the Bitcoin Network and

Blockchain technology has many built-in security features

that make it difficult for hackers and other malicious actors to corrupt the protocol or blockchain.

However, as with any computer network,

the Bitcoin network may be subject to certain attacks.

Some forms of attack include unauthorized access to wallets that hold bitcoin and

direct attacks, like “51% attacks” or “denial-of-service attacks” on the Bitcoin network.

Bitcoin is controllable only by the possessor of both

the unique public key and private key(s) relating to the local or online digital wallet in which the bitcoin is held.

used to access bitcoin balances are not widely distributed and are typically held on hardware (which can be physically controlled by the

holder or by a third party such as a custodian) or via software programs on third-party servers.

One form of obtaining unauthorized access

to a wallet occurs following a phishing attack where the attacker deceives the victim and manipulates them into sharing their private

keys for their digital wallet or other sensitive information.

Other similar attacks may also result in the loss of private keys and the

inability to access, and effective loss of, the corresponding bitcoin.

A “51% attack” may occur when a group

of miners attain more than 50% of the Bitcoin network’s mining power, thereby enabling them to control the Bitcoin network and protocol

and manipulate the blockchain.

A “denial-of-service attack” occurs when legitimate users are unable to access information

systems, devices, or other network resources due to the actions of a malicious actor flooding the network with traffic until the network

is unable to respond or crashes.

The Bitcoin network has been, and can be in the future, subject to denial-of-service attacks, which can

result in temporary delays in block creation and in the transfer of bitcoin.

Bitcoin Industry Participants

The primary Bitcoin industry participants are miners,

investors and traders, digital asset exchanges and service providers, including custodians, brokers, payment processors, wallet providers

and financial institutions.

Miners range from bitcoin enthusiasts

to professional mining operations that design and build dedicated mining machines and data centers, including mining pools, which are

groups of miners that act cohesively and combine their processing power to mine bitcoin blocks.

See “— Creation

of New Bitcoin and Limits on Supply” above.

Investors and Traders.

Bitcoin investors

and traders include individuals and institutional investors who, directly or indirectly, purchase, hold, and sell bitcoin or bitcoin-based

On January 10, 2024, the Securities and Exchange Commission (“ SEC ”) issued an order approving several

applications for the listing and trading of shares of spot bitcoin exchange-traded products (“ ETPs ”) on U.S.

securities exchanges.

While the SEC had previously approved exchange-traded funds where the underlying assets were bitcoin futures contracts,

this order represented the first time the SEC approved the listing and trading of ETPs that acquire, hold and sell bitcoin directly.

can be bought and sold on a stock exchange like traditional stocks, and provide investors with another means of gaining economic exposure

to bitcoin through traditional brokerage accounts.

Digital Asset Exchanges.

Digital asset

exchanges provide trading venues for purchases and sales of bitcoin in exchange for fiat or other digital assets.

Bitcoin can be exchanged

for fiat currencies, such as the U.S.

dollar, at rates of exchange determined by market forces on bitcoin trading platforms, which

are not regulated in the same manner as traditional securities exchanges.

In addition to these platforms, over-the-counter markets and

derivatives markets for bitcoin also exist.

The value of bitcoin within the market is determined, in part, by the supply of and demand

for bitcoin in the global bitcoin market, market expectations for the adoption of bitcoin as a store of value, the number of merchants

that accept bitcoin as a form of payment, and the volume of peer-to-peer transactions, among other factors.

Service providers.

Service providers offer

a multitude of services to other participants in the Bitcoin industry, including custodial and trade execution services, commercial and

retail payment processing, wallet solutions and financial institutions.

If adoption of the Bitcoin network continues to materially increase,

we anticipate that service providers may expand the currently available range of services and that additional parties will enter the service

sector for the Bitcoin network.

Other Digital Assets

As of the date of this Annual Report, bitcoin

was the largest digital asset by market capitalization.

However, numerous alternative digital assets exist, and many entities, including

consortia and financial institutions, are actively researching and investing resources in blockchain platforms and digital assets that

utilize consensus mechanisms other than proof-of-work mining, which is employed by the Bitcoin network.

For example, in late 2022, the

Ethereum network transitioned to a “proof-of-stake” mechanism for validating transactions that requires significantly less

computing power than proof-of-work mining.

Other alternative digital assets that compete with bitcoin in certain ways include “stablecoins,”

which are designed to maintain a constant price because of their issuers’ promise to hold high-quality liquid assets (such as U.S.

deposits and short-term U.S.

treasury securities) equal to the total value of stablecoins in circulation.

Stablecoins have grown

rapidly as an alternative to bitcoin and other digital assets as a medium of exchange and store of value, particularly on digital asset

trading platforms.

As of December 31, 2024, two of the eight largest digital assets by market capitalization were U.S.

dollar-backed

Additionally, central banks in some countries have

started to introduce digital forms of legal tender.

For example, China’s central bank digital currency (“ CBDC ”)

project was made available to consumers in January 2022, and governments including the United States and the European Union

have discussed the potential creation of new CBDCs.

Our Market Opportunity for Institutional Bitcoin

Treasury and DAT Solutions

The use of Bitcoin as a corporate treasury reserve

asset has expanded as companies and institutions evaluate alternatives to traditional cash management strategies.

While fiat currency

and short-term government securities remain predominant, the emergence of U.S.

spot Bitcoin exchange-traded funds and increasing

recognition of Bitcoin as an investable asset class have contributed to broader institutional acceptance.

A growing number of public and

private companies, investment funds, and other institutional allocators have begun to evaluate or adopt Bitcoin reserves as a potential

long-term store of value and as a component of diversified treasury strategies.

Despite these developments, adoption of Bitcoin for

treasury purposes remains limited relative to the overall size of global corporate treasury balances.

We believe this gap highlights a

meaningful market opportunity for institutional-grade platforms that can provide compliant, transparent, and risk-managed infrastructure

for Bitcoin treasury operations.

Key needs we see in the market include secure custody with segregation and controls;

governance frameworks

aligned with public-company standards;

accounting and reporting support;

risk-managed yield programs;

and integration into existing treasury

We believe there is an opportunity to differentiate

by offering an integrated DAT solution that combines:

(i) corporate Bitcoin treasury infrastructure designed for institutional policies

and controls;

(ii) AI-supported, risk-managed yield programs intended to produce programmatic returns on reserve assets;

validator-enabled ecosystem that supports network participation and governance, with utility powered by our native token, $NILA.

institutional comfort and regulatory clarity continue to develop, we expect the use of Bitcoin in treasury management to expand, supported

by demand for transparent, regulated, and operationally disciplined solutions.

In our view, market growth will be driven by several

secular trends:

increased institutional access to Bitcoin through regulated vehicles and service providers;

enhancements in custody, compliance,

and accounting standards;

and the need for end-to-end platforms that allow corporate treasury teams to implement Bitcoin strategies without

building bespoke infrastructure.

Our platform is being developed to address these requirements by providing segregation, controls, monitoring,

and reporting consistent with institutional expectations, along with programmatic yield and validator capabilities designed to complement

a Bitcoin-centric reserve posture.

Our Products and Services

Our principal planned products and services focus

on delivering an institutional Digital Asset Treasury (“DAT”) platform that enables corporations and institutions to hold,

manage, and generate yield on Bitcoin reserves through a compliant, scalable infrastructure.

We are in the development execution stage

and are actively building the underlying architecture, governance, and partnerships necessary to support future commercialization.

Institutional DAT Platform

● Corporate Bitcoin treasury infrastructure.

Segregated wallet

architecture, permissions and controls, and reporting designed to align with institutional compliance frameworks and public-company balance

sheet requirements.

● AI-supported yield programs.

Risk-managed strategies intended

to produce programmatic returns on Bitcoin reserves, with governance, monitoring, and risk limits tailored for institutional participants.

● Validator-enabled ecosystem.

Network operations that support

validator economics and governance across our interoperable platforms, with utility powered by our native token, $NILA.

● Compliance and risk management.

Policies and tooling addressing

AML/KYC, ongoing monitoring, collateral and reserve discipline where relevant to client programs, and real-time risk analytics.

● Advisory and enablement.

Onboarding and operational support

to help clients adopt institutional Bitcoin treasury standards, including segregation, reconciliation, and controls.

Treasury Reserve and Bitcoin Strategy

Our group maintains a Bitcoin-centric reserve posture

that aligns with our DAT platform.

This approach is intended to preserve purchasing power, provide continuous exposure to Bitcoin, and

support our yield and validator infrastructure.

From time to time, we may evaluate capital raising transactions to fund platform development,

operations, and reserve strategy, subject to market conditions, risk management, regulatory considerations, and anticipated operating

Custody and Execution Services

We intend to utilize regulated third-party custodians

and institutional-grade wallet solutions for the safekeeping of any client assets onboarded to our platform, as well as our operating-subsidiary

These providers are expected to support secure custody, segregation, and controls, and to offer affiliated execution services

for Bitcoin acquisitions and dispositions consistent with institutional best practices.

Ecosystem Verticals Powered by $NILA

In addition to our core Digital Asset Treasury (“ DAT ”)

platform, we operate interoperable verticals powered by our native token, $NILA, which enables governance, utility, and value flow across

our ecosystem.

● ClimateTech (AQUAE Impact).

One our ecosystems is a blockchain-powered

sustainability engine intended to generate verifiable, insured environmental impact outcomes, including fractionalized credits linked

to analog forest projects and other conservation efforts.

The roadmap contemplates phases focused on expanding analog forest capacity,

introducing water-conservation and biodiversity credits, and building a secondary market for the exchange of such credits.

● AdTech (Wave+).

Another ecosystem is a micro-engagement

platform to convert user attention into tokenized value for brand and mission-aligned campaigns.

The platform is designed to support

daily active engagement, with contemplated revenue streams from ad placements, partner campaigns, and conversion fees.

● InsurTech (Institutional Insurance Engine).

We are designing

an insurance framework to complement digital treasury strategies through surplus-capital-style models backed by strengthened, Bitcoin-centric

balance sheets.

The goal is to support treasury protection, parametric digital-asset coverage, and institutional insurance primitives

that can be integrated with our DAT platform.

Validator Infrastructure

We intend to operate enterprise-grade validator nodes

to support network participation, governance, and rewards within our ecosystem and for institutional clients.

The validator stack

is being developed with an emphasis on high availability, slashing prevention, hardware security (including HSM/TEE-based protections),

governance controls, and policy-limited MEV/PBS participation.

Anticipated revenue drivers include staking rewards, protocol incentives,

enterprise validator service fees, and ecosystem transaction fees.

Revenue Model

Our contemplated revenue model includes multiple streams

that align with institutional treasury adoption:

● Treasury Management Fees:

Asset-under-management-based

fees for corporate treasury wallets and related services.

● Performance and Program Fees:

Participation in net returns

from AI-supported yield programs, subject to institutional governance and risk policies.

● Validator Services and Protocol Incentives:

staking and validator service fees, protocol-derived incentives, and transaction-based revenues tied to ecosystem activity.

associated with ClimateTech (e.g., fractionalized credits), AdTech (campaign and placement revenue), and InsurTech-related structures,

where applicable.

Our Customers

We target enterprise clients that require institutional

governance, custody segregation, and audit-ready reporting for Bitcoin treasury operations, including public and private corporate treasury

teams, institutional investors and asset managers, financial institutions and intermediaries, and high-net-worth organizations with significant

Bitcoin reserves.

We aim to integrate into CFO, treasury, and risk committee workflows, including policy design, compliance and accounting

support, and board-level reporting.

We have generated revenues and do not currently rely

on any single customer for more than 10% of our revenues.

Our Market Positioning

We believe our market positioning is strengthened

by the integration of our institutional Digital Asset Treasury (“ DAT ”) platform, segregated custody architecture, and

Bitcoin-centric reserve posture.

Our platform is designed to enable corporations and institutions to implement Bitcoin treasury operations

with the governance, controls, and reporting expected by institutional stakeholders, while complementing those reserves with AI-supported,

risk-managed yield programs and validator participation within our broader ecosystem.

Our Bitcoin holdings are maintained primarily as a

treasury reserve asset intended to support our balance sheet and operational resilience.

Our reserve posture reinforces our credibility

with institutional clients by aligning our incentives with a Bitcoin-centric treasury strategy and by demonstrating disciplined custody,

segregation, and control practices.

By maintaining a Bitcoin-centric reserve posture and

building end-to-end DAT infrastructure, we aim to provide a comprehensive, compliant, and scalable pathway for institutions to adopt Bitcoin

in treasury management.

This integration of reserve management, custody controls, yield programs, and validator operations is intended

to enhance risk management, support operational discipline, and provide a foundation for long-term value creation.

Our Competitive Strengths

Platform Governance and $NILA Utility

$NILA functions as a governance and utility token

within our ecosystem, facilitating validator participation, program access, and value exchange across verticals.

Governance processes

are designed to be policy-driven and auditable, with the objective of aligning incentives among stakeholders while maintaining institutional

Within our validator framework, we intend to limit protocol participation to policy-permitted activities and to maintain

risk controls, including stake diversification, slashing protection, and real-time monitoring.

We believe the following strengths position us to

compete effectively in the emerging institutional Bitcoin treasury market:

● Institutional DAT stack.

End-to-end infrastructure for

corporate Bitcoin treasury operations, including secure wallet architecture, permissions and controls, reconciliation, and reporting

aligned with institutional requirements.

● Segregated custody architecture.

Use of institutional-grade

wallet solutions and regulated third-party providers for safekeeping, with segregation and control frameworks designed to mitigate counterparty

and operational risks.

● Bitcoin-centric reserve posture.

A treasury strategy centered

on Bitcoin reserves intended to preserve purchasing power, maintain continuous exposure, and support platform credibility with institutional

● AI-supported yield programs.

Risk-managed strategies intended

to produce programmatic returns on reserve assets, governed by policies, monitoring, and limits consistent with institutional risk management.

● Validator-enabled ecosystem.

Network participation that

supports validator economics and governance across interoperable platforms, with utility powered by our native token, $NILA.

● Compliance and governance.

Emphasis on AML/KYC, surveillance,

and real-time risk monitoring, together with operational controls designed to align with institutional and public-company standards.

● Scalable partner network.

Strategic relationships with

custodians, wallet providers, financial institutions, and other service partners to support onboarding, execution, and operational scale.

● Operational discipline.

A focus on segregation, transparency,

and audit-ready processes to support institutional adoption and long-term sustainability.

We believe our integrated approach — combining

corporate Bitcoin treasury infrastructure, AI-supported yield programs, validator operations, and interoperable verticals powered by $NILA — addresses

key adoption barriers by offering a policy-driven, audit-ready, and scalable pathway for institutions.

Our multi-vertical design

is intended to enhance network effects and create diversified revenue opportunities aligned with institutional compliance and governance

expectations.

Custody of Our Bitcoin

Our Bitcoin reserve is maintained within a segregated

sub-wallet architecture created and administered by MindWave Ltd.

for the benefit of our operating subsidiary, TechyTrade (Dubai).

(Dubai) holds the private keys and retains full beneficial ownership and control of the segregated wallet(s).

The 1,000 Bitcoin are identifiable,

segregated, and held free and clear of any encumbrances.

This structure is intended to mitigate counterparty exposure associated with

omnibus custody while maintaining operational controls and traceability over our reserve assets.

We conduct diligence and ongoing oversight of our

wallet architecture and related service providers, focusing on segregation, key-management controls, access permissions, and incident-response

Our controls emphasize least-privilege access, multi-factor authentication, operational separation of duties, and audit trails

for key interactions and movement authorizations.

We supplement these controls with periodic independent attestations to verify the existence,

segregation, and control of our Bitcoin holdings as of specified dates.

For any client assets that may be onboarded to our

platform in the future, we expect to utilize regulated third-party custodians and institutional-grade wallet solutions, implemented within

a segregation and control framework designed to meet institutional compliance requirements (including AML/KYC, monitoring, and reporting).

We anticipate diversifying custody solutions as appropriate to support risk management and operational resilience, and we will evaluate

additional custodial partners over time.

Where we engage third-party providers, we expect to

conduct initial and periodic reviews of their security, operations, and controls, including — but not limited to — key-management

practices, cold-storage policies, cybersecurity programs, business continuity and disaster recovery readiness, and the availability of

third-party assurance reporting.

We also seek contractual provisions addressing segregation of assets and clarifying that digital assets

held for our benefit are not part of a custodian’s bankruptcy estate under applicable law.

We continuously monitor the safekeeping of our Bitcoin

through internal controls, reconciliation, and external confirmations, and we will conduct supplemental diligence when warranted by market

conditions or other circumstances.

Policy Framework and Risk Management

We are building our platform around policy-based governance

intended to satisfy institutional requirements and auditor expectations.

Core elements include board-approved asset allocation and transaction

policies, segregation of duties, multi-step approval workflows, transaction screening, real-time solvency and exposure limits, and emergency

protocol “kill-switches.” For yield programs, we intend to maintain leverage caps, counterparty concentration limits, daily

reconciliations, and tail-risk hedging parameters.

For validator operations, we emphasize uptime targets, redundancy, slashing prevention,

and pre-defined MEV/PBS participation rules.

We expect to produce periodic “audit packs,” including reconciliations and

control attestations, for institutional users.

Potential Advantages and Disadvantages of Holding

We believe that bitcoin is an attractive asset because

it can serve as a store of value, supported by a robust and public open-source architecture, that is untethered to sovereign monetary

We also believe that, due to its limited supply, bitcoin offers the potential to serve as a hedge against inflation in the long-term

and, if its adoption increases, the opportunity for appreciation in value.

Bitcoin exists entirely in electronic form, as virtually

irreversible public transaction ledger entries on the blockchain, and transactions in bitcoin are recorded and authenticated not by a

central repository, but by a decentralized peer-to-peer network.

This decentralization mitigates the risks of certain threats common to

centralized computer networks, such as denial-of-service attacks, and reduces the dependency of the bitcoin network on any single system.

The decentralization of user nodes and miners also mitigates the risk of a 51% attack, which would be very costly and difficult to execute

with respect to bitcoin because the Bitcoin network is open source and widely distributed, and transactions on the blockchain require

significant computing power to be validated.

However, while the Bitcoin network as a whole is decentralized, the private keys used to

access bitcoin balances are not widely distributed and are susceptible to phishing and other attacks designed to obtain sensitive

information or gain access to password-protected systems.

Loss of such private keys can result in an inability to access, and effective

loss of, the corresponding bitcoin.

Consequently, bitcoin holdings are susceptible to all of the risks inherent in holding any electronic

data, such as power failure, data corruption, security breach, communication failure and user error, among others.

These risks, in turn,

make bitcoin substantially more susceptible to theft, destruction, or loss of value from hackers, corruption, viruses and other technology-specific

factors as compared to conventional fiat currency or other conventional financial assets.

In addition, the Bitcoin network relies on open-source

developers to maintain and improve the Bitcoin protocol.

Accordingly, bitcoin may be subject to protocol design changes, governance disputes

such as “forked” protocols, competing protocols, and other open source-specific risks that do not affect conventional proprietary

Government Regulation

The laws and regulations applicable to bitcoin and

digital assets are evolving and subject to interpretation and change.

Governments around the world have reacted differently

to digital assets;

certain governments have deemed them illegal, and others have allowed their use and trade without restriction, while

in some jurisdictions, such as the U.S., digital assets are subject to overlapping, uncertain and evolving regulatory requirements.

As digital assets have grown in both popularity and

market size, the U.S.

Executive Branch, Congress and a number of U.S.

federal and state agencies, including the Financial Crimes

Enforcement Network (“FinCEN”), the Commodity Futures Trading Commission (“CFTC”), the SEC, the Financial Industry

Regulatory Authority (“FINRA”), the Consumer Financial Protection Bureau (“CFPB”), the Department of Justice,

the Department of Homeland Security, the Federal Bureau of Investigation, the Internal Revenue Service (“IRS”) and state financial

regulators, have been examining the operations of digital asset networks, digital asset users and digital asset exchanges, with particular

focus on the extent to which digital assets can be used to violate state or federal laws, including to facilitate the laundering of proceeds

of illegal activities or the funding of criminal or terrorist enterprises, and the safety and soundness and consumer-protective safeguards

of exchanges or other service-providers that hold, transfer, trade or exchange digital assets for users.

Many of these state and federal

agencies have issued consumer advisories regarding the risks posed by digital assets to investors.

In addition, federal and state agencies,

and other countries have issued rules or guidance regarding the treatment of digital asset transactions and requirements for businesses

engaged in activities related to digital assets.

Depending on the regulatory characterization of bitcoin,

the markets for bitcoin in general, and our activities in particular, our business and our bitcoin strategy may be subject to regulation

by one or more regulators in the United States and globally.

Ongoing and future regulatory actions may alter, to a materially adverse

extent, the nature of digital assets markets, the participation of industry participants, including service providers and financial institutions

in these markets, and our ability to pursue our bitcoin strategy.

Additionally, U.S.

state and federal and foreign regulators and

legislatures have taken action against industry participants, including digital assets businesses, and enacted restrictive regimes in

response to adverse publicity arising from hacks, consumer harm, or criminal activity stemming from digital assets activity.

and state energy regulatory authorities are also monitoring the total electricity consumption of cryptocurrency mining, and the potential

impacts of cryptocurrency mining to the supply and dispatch functionality of the wholesale grid and retail distribution systems.

state legislative bodies have passed, or are actively considering, legislation to address the impact of cryptocurrency mining in their

respective states.

The CFTC takes the position that some digital assets,

including bitcoin, fall within the definition of a “commodity” under the Commodities Exchange Act of 1936,

as amended (the “CEA”).

Under the CEA, the CFTC has broad enforcement authority to police market manipulation and fraud in

spot digital assets markets in which we may transact.

Beyond instances of fraud or manipulation, the CFTC generally does not oversee cash

or spot market exchanges or transactions involving digital asset commodities that do not utilize margin, leverage, or financing.

CFTC regulations and CFTC oversight and enforcement authority apply with respect to futures, swaps, other derivative products and certain

retail leveraged commodity transactions involving digital asset commodities, including the markets on which these products trade.

The SEC and its staff have taken the position that

certain other digital assets fall within the definition of a “security” under the U.S.

federal securities laws.

statements made by senior officials and senior members of the staff at the SEC indicate that the SEC does not consider bitcoin to be a

security under the federal securities laws.

However, such statements are not official policy statements by the SEC and reflect only the

speakers’ views, which are not binding on the SEC or any other agency or court and cannot be generalized to any other digital assets.

In addition, since transactions in bitcoin provide a degree of anonymity, they are susceptible to misuse for criminal activities, such

as money laundering.

This misuse, or the perception of such misuse, could lead to greater regulatory oversight of bitcoin and Bitcoin

platforms, and there is the possibility that law enforcement agencies could close or blacklist bitcoin platforms or other bitcoin-related

infrastructure with little or no notice and prevent users from accessing or retrieving bitcoin held via such platforms or infrastructure.

For example, the U.S.

Treasury Department’s Office of Foreign Assets Control has issued updated advisories regarding the use

of virtual currencies, added a number of digital asset exchanges and service providers to the Specially Designated Nationals and

Blocked Persons list and engaged in several enforcement actions, including a series of enforcement actions that have either shut down

or significantly curtailed the operations of several smaller digital asset exchanges associated with Russian and/or North Korean nationals.

Additionally, in January 2025, the Consumer Financial Protection Bureau announced that it is seeking public input on privacy protections

and surveillance in digital payments, particularly those offered through large technology platforms.

As noted above, activities involving bitcoin and other

digital assets may fall within the jurisdiction of more than one financial regulator and various courts and such laws and regulations

are rapidly evolving and increasing in scope.

On January 23, 2025, President Trump issued an executive order titled, Strengthening

American Leadership in Digital Financial Technology.

While the executive order did not mandate the adoption of any specific regulations,

the executive order identifies certain key objectives to guide agencies involved in crypto regulation, including (i) protecting the

sovereignty of the United States dollar by promoting the development of United States dollar-backed stablecoins, (ii) providing

regulatory clarity and certainty built on technology-neutral regulations for individuals and firms involved in digital assets, including

through well-defined jurisdictional regulatory boundaries, and (iii) taking measures to protect Americans from the risks of Central

Bank Digital Currencies.

To achieve these objectives, the executive order established a working group on digital asset markets within

the National Economic Council, comprised of representatives from key federal agencies, with a tight timeline for examining existing regulations

and proposing a new regulatory framework.

There have also been several bills introduced in Congress that propose to establish additional

regulation and oversight of the digital asset markets.

Aspects of our business involve collecting, processing,

disclosing, storing, and transmitting personal data, which are subject to certain privacy policies, contractual obligations, and U.S.

foreign laws, regulations, and directives relating to privacy and data protection.

There are a broad variety of other data protection

laws in the United States that are or may be applicable to our activities, and a wide range of enforcement agencies at both the state

and federal levels that can review companies for privacy and data security concerns based on general consumer protection laws.

Trade Commission and state Attorneys General all are aggressive in reviewing privacy and data security protections for consumers.

laws also are being considered at both the state and federal levels.

A broad range of legislative measures also have been introduced at

the federal level.

Accordingly, failure to comply with federal and state laws (both those currently in effect and future legislation)

regarding privacy and security of personal information could expose us to fines and penalties under such laws.

In the event of a security

breach, we also may have obligations to notify our customers or other parties or individuals about this breach, and this can lead to significant

costs and the risk of potential enforcement and/or litigation.

There is also a threat of consumer class actions related to these laws

and the overall protection of personal data.

Even if we are not determined to have violated these laws, government investigations into

these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our reputation

and our business.

There are similar laws in other countries, including

the General Data Protection Regulation (“GDPR”) in the European Union which imposes requirements regarding the handling and

security of personal data, requires disclosure of data breaches to individuals, customers, and data protection authorities in certain

circumstances, requires companies to honor data subjects’ requests relating to their personal data, permits regulators to impose

fines of up to €20,000,000 or 4% of global annual revenue, whichever is higher, and establishes a private right of action.

In addition to these specific laws, we also are subject

to other privacy, security, and data protection laws around the world.

In addition to the laws in place already, other countries are also

considering new or expanded laws governing privacy and data security that may impact our business practices.

These laws may impact our

ongoing business activities and our relationships with our business partners, customers and service providers.

Furthermore, the U.S.

Congress is considering

comprehensive privacy legislation.

At this time, it is unclear whether Congress will pass such a law and if so, when and what it will

require and prohibit.

Moreover, it is not clear whether any such legislation would give the Federal Trade Commission (“FTC”)

any new authority to impose civil penalties for violations of the Federal Trade Commission Act in the first instance, whether Congress

will grant the FTC rulemaking authority over privacy and information security, or whether Congress will vest some or all privacy and data

security regulatory authority and enforcement power in a new agency, akin to EU data protection authorities.

Sales and Marketing

Our sales and marketing strategy is designed to expand

awareness of our institutional DAT platform, build credibility with corporate treasury teams and institutional allocators, and drive adoption

of our offerings across target enterprise markets.

Key elements include strategic partnerships, targeted distribution through enterprise

sales and channels, and education-led marketing that emphasizes governance, compliance, and risk management.

Strategic Partnerships

We intend to rely on strategic relationships with

regulated custodians, institutional-grade wallet providers, financial institutions, accounting and audit advisors, and other digital-asset

service providers to support our treasury operations and client enablement.

Because we are not directly licensed to provide custody, execution,

or intermediation services, we expect these partners to supply the necessary regulatory infrastructure and, in certain cases, act as distribution

These relationships are expected to support secure custody, segregation and control frameworks, execution services for Bitcoin

acquisitions and dispositions, validator operations, and programmatic risk management.

We also expect to collaborate with placement agents

and traditional financial institutions to broaden institutional reach and facilitate client onboarding.

We will continue to evaluate additional

partnerships with enterprise software integrators, cloud and security vendors, and protocol-level partners to enhance scale, resilience,

and interoperability.

Distribution Methods

We plan to distribute our DAT solutions directly to

enterprise clients through internal business development and relationship management teams focused on corporate treasuries, institutions,

and financial intermediaries.

In addition, we expect to leverage partnerships with custodians, wallet providers, and financial institutions

to support client acquisition, onboarding, and ongoing operations.

Over time, we anticipate supplementing these channels with participation

in industry conferences and education-led initiatives, including research and thought-leadership publications tailored for CFOs, treasury

leaders, boards, and risk committees.

We do not expect to rely on mass-market retail marketing programs.

We intend to emphasize education, transparency, and

strategic engagement aligned with institutional standards.

We expect to target the following principal audiences:

● Corporate treasury managers and CFO organizations seeking to

integrate Bitcoin into reserve strategies with institutional governance, controls, and reporting.

● Institutional investors and asset managers, including hedge

funds and family offices, seeking institutional-grade custody, risk-managed yield programs, and validator-enabled capabilities.

● Financial institutions and intermediaries evaluating Bitcoin

treasury offerings for their clients and seeking compliant, scalable infrastructure.

● High-net-worth individuals with significant Bitcoin holdings

who require institutional-grade custody, governance, and programmatic operations.

Our marketing strategy is expected to combine targeted

enterprise outreach, channel partnerships, and education-driven content intended to promote responsible adoption of institutional Bitcoin

treasury practices while reinforcing MindWave’s commitment to compliance, governance, and long-term value creation.

Intellectual Property

We rely on a combination of proprietary software,

trade secrets, and contractual protections to develop and operate our DAT platform, including components related to wallet orchestration,

segregation and controls, risk analytics, AI-supported yield programs, and validator operations.

We also rely on confidentiality and invention-assignment

agreements with employees, contractors, and partners.

From time to time, we may pursue trademark protection for brand names and logos

associated with our products and ecosystem (including, for example, MindWave and $NILA), and we will evaluate additional intellectual

property protections as our platform develops and markets evolve.

Our business is not subject to material seasonal variations.

However, our results of operations may be affected by fluctuations in the market price of bitcoin and by the timing of capital raising

activities, which may not occur evenly throughout the year.

As of January 11, 2026, we had a total of 9 employees,

none of whom are based in the United States.

None of our employees are represented by a labor union.

We have not experienced any

work stoppages and generally consider our relations with our employees to be good.

Legal Proceedings

From time to time, we may be involved in legal

proceedings, claims, or regulatory matters arising in the ordinary course of business.

As of the date of this Annual Report, we are not

a party to any material pending legal proceedings, nor are we aware of any such proceedings contemplated by governmental authorities.

On April 24, 2026, the Company, MindWave, and

Lokahi Therapeutics, Inc., a Nevada corporation (“ Lokahi ” and, together with the Company and MindWave, the “ Company

Parties ”), together with Erik Emerson, individually and in his capacity as Bio Business Representative under the Merger Agreement,

entered into a Confidential Settlement and Mutual Release Agreement (the “ Settlement Agreement ”) with Inscobee Inc.,

a South Korean corporation (“ Inscobee ”), and Apimeds Inc., a South Korean corporation and wholly owned subsidiary of

Inscobee (“ Apimeds Korea ” and, together with Inscobee, the “ Inscobee Parties ”).

Concurrently with

the Settlement Agreement, the Company Parties and the Inscobee Parties also entered into a Side Letter Agreement (Merger Unwind Conditions)

(the “ Side Letter ”), which is incorporated into and forms part of the Settlement Agreement.

The Settlement Agreement resolves all outstanding

disputes among the parties arising from the Merger Agreement and related transactions.

Also on April 30, 2026,

the Company entered into a Forbearance Agreement (the “ Forbearance Agreement ”) with Alto Opportunity Master Fund, SPC

– Segregated Master Portfolio B (the “ Investor ”), which holds a senior convertible note in the aggregate original

principal amount of $11,000,000 (the “ Existing Note ”), issued pursuant to a Securities Purchase Agreement, dated

December 1, 2025 (the “ Securities Purchase Agreement ”).

Pursuant to the Forbearance Agreement, the Investor

has agreed to forbear from exercising any of its rights or remedies under the Existing Note with respect to certain existing events of

default (collectively, the “ Existing Defaults ”) during the period commencing on the date of the Forbearance Agreement

through and including June 30, 2026 (or such later date as the Investor may elect in its sole discretion) (the “ Forbearance Period ”).

The Settlement Agreement, the Side Letter, and

the Forbearance Agreement are described in the Company’s Current Report on Form 8-K filed with the SEC on May 3, 2026, and are

incorporated herein by reference.

Our principal executive offices are located at 60

Paya Lebar Road #04-23, Singapore 409051.

Available Information

Our website is located at www.mindwavedao.com .

As a smaller reporting company, as defined in Rule

12b-2 of the Exchange Act, we are not required to provide the information required by this Item.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business