UNITED STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM 10-K

For the fiscal

year ended December 31, 2025

For the transition

period from__________ to ___________

Commission

file number 001-32188

ORAGENICS,

INC.

(Exact name

of registrant as specified in its charter)

9015 Town Center Parkway, Suite 143, Lakewood Ranch, FL 34202

(Address of Principal Executive Offices) (Zip Code)

813-286-7900

(Registrant’s

Telephone Number, Including Area Code)

SECURITIES

REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:

Title of each class Trading Symbol Name of each exchange on which registered

Common Stock $0.001 par value per share OGEN NYSE AMERICAN

SECURITIES

REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:

None

Indicate by

check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by

check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ☐

No ☒

Indicate by

check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act

of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has

been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by

check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405

of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was

required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large, accelerated filer,

an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large,

accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company”

in Rule 12b-2 of the Exchange Act.

☐ Large, accelerated filer ☐ Accelerated filer

☒ Non-accelerated filer ☒ Smaller reporting company

☐ Emerging growth company

If an emerging

growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any

new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by

check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its

internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public

accounting firm that prepared or issued its audit report. ☐

If securities

are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included

in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by

check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received

by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by

check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2). Yes ☐ No ☒

The aggregate

market value of the voting and non-voting common equity stock held by non-affiliates of the registrant, was approximately $3,126,135

computed based upon a last sales price of $3.82 as reported by the NYSE American as of June 30, 2025, the last business day of the registrant’s

most recently completed second fiscal quarter.

As of March

13, 2026, there were 4,336,029 shares of the registrant’s Common stock outstanding.

Note

Regarding Reverse Stock Split

June 3, 2025, the Company effected a 1-for-30 reverse stock split of its outstanding common stock. All share and per share amounts in

these consolidated financial statements and related footnotes have been retroactively adjusted to reflect the reverse stock split for

all periods presented in the accompanying financial statements, unless otherwise indicated (the “Reverse Stock Split”).

TABLE

OF CONTENTS

FORWARD-LOOKING STATEMENTS AND CERTAIN CONSIDERATIONS ii

PART I

ITEM 1. BUSINESS 1

ITEM 1A. RISK FACTORS 21

ITEM 1B. UNRESOLVED STAFF COMMENTS 54

ITEM 1C. CYBERSECURITY 54

ITEM 2. PROPERTIES 55

ITEM 3. LEGAL PROCEEDINGS 55

ITEM 4. MINE SAFETY DISCLOSURES 55

PART II

ITEM 6. RESERVED 56

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 63

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 63

ITEM 9A. CONTROLS AND PROCEDURES 63

ITEM 9B. OTHER INFORMATION 64

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 64

PART III

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 65

ITEM 11. EXECUTIVE COMPENSATION 68

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 82

PART IV

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 83

SIGNATURES 84

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM F-2

CONSOLIDATED BALANCE SHEETS F-3

CONSOLIDATED STATEMENTS OF OPERATIONS F-4

CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ (DEFICIT) EQUITY F-5

CONSOLIDATED STATEMENTS OF CASH FLOWS F-6

CONSOLIDATED NOTES TO FINANCIAL STATEMENTS F-7

FORWARD

LOOKING STATEMENTS AND CERTAIN CONSIDERATIONS

This

report, along with other documents that are publicly disseminated by us, contains or might contain forward-looking statements within

the meaning of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements included in this report

and in any subsequent filings made by us with the Securities and Exchange Commission (the “SEC”) other than statements of

historical fact, that address activities, events or developments that we or our management expect, believe or anticipate will or may

occur in the future are forward-looking statements. These statements represent our reasonable judgment on the future based on various

factors and using numerous assumptions and are subject to known and unknown risks, uncertainties and other factors that could cause our

actual results and financial position to differ materially. We claim the protection of the safe harbor for forward-looking statements

provided in the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act and Section 21E of the Exchange Act.

Examples of forward-looking statements include: (i) projections of revenue, earnings, capital structure and other financial items, (ii)

statements of our plans and objectives, (iii) statements of expected future economic performance, and (iv) assumptions underlying statements

regarding us or our business. Forward-looking statements can be identified by, among other things, the use of forward-looking language,

such as “believes,” “expects,” “estimates,” “may,” “will,” “should,”

“could,” “seeks,” “plans,” “intends,” “anticipates” or “scheduled to”

or the negatives of those terms, or other variations of those terms or comparable language, or by discussions of strategy or other intentions.

Forward-looking

statements are subject to known and unknown risks, uncertainties and other factors that could cause the actual results to differ materially

from those contemplated by the statements. The forward-looking information is based on various factors and was derived using numerous

assumptions. Important factors that could cause our actual results to be materially different from the forward-looking statements include

the following risks and other factors discussed under the Item 1A “Risk Factors” in this Annual Report on Form 10-K. These

factors include:

● The timing, progress and results of clinical trials of our product candidates;

● Our ability to successfully commercialize our product candidates;

● Our ability to identify, recruit and retain key personnel and consultants;

● The safety, efficacy, and benefits of our product candidates;

caution investors that actual results or business conditions may differ materially from those projected or suggested in forward-looking

statements as a result of various factors including, but not limited to, those described above and in the Risk Factors section of this

report. We cannot assure you that we have identified all the factors that create uncertainties. Moreover, new risks emerge from time

to time, and it is not possible for our management to predict all risks, nor can we assess the impact of all risks on our business or

the extent to which any risk, or combination of risks, may cause actual results to differ from those contained in any forward-looking

statements. Readers should not place undue reliance on forward-looking statements. Except as required by applicable law, we undertake

no obligation to publicly release the result of any revision of these forward-looking statements to reflect events or circumstances after

the date they are made or to reflect the occurrence of unanticipated events.

PART

ITEM

1. BUSINESS.

This

description contains certain forward-looking statements that involve risks and uncertainties. Our actual results could differ materially

from the results discussed in the forward-looking statements as a result of certain of the risks set forth herein. We assume no obligation

to update any forward-looking statements contained herein.

Overview

are a development-stage biopharmaceutical company dedicated to the research and development of nasal delivery pharmaceutical therapies

targeting neurological conditions and infectious diseases. The Company is currently focused on advancing the development and commercialization

of its lead product candidate, ONP-002. Our lead product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid, is lipophilic,

and we believe it can cross the blood-brain barrier with the goal of rapidly eliminating swelling, oxidative stress and inflammation

while restoring proper blood flow through gene amplification.

Our

ONP-002 Neurology Asset for Brain Related Illness and Injury

Our

lead product and focus are on the development and commercialization of ONP-002 for the treatment of mild traumatic brain injury (“mTBI”

or “Concussion”).

ONP-002,

together with our other neurology assets, are referred to herein as the Neurology Assets. To date, ONP-002 has been shown to be stable

up to 104 degrees for 18 months. The drug candidate is manufactured into a powder and filled into a novel intranasal device. The drug

is then administered through the nasal passage from the device. The novel intranasal device is lightweight and easy to use in the field.

believe the proprietary powder formulation and intranasal administration allows for rapid and direct accessibility to the brain. The

device is breath propelled and is designed to allow patients to blow into the device which closes the soft palate in the back of the

nasopharynx, preventing the flow of drug to the lungs or esophagus, minimizes system exposure and side effects, and effectively crosses

the blood brain barrier. This mechanism is designed to trap ONP-002 in the nasal cavity allowing for more abundant and faster drug availability

in the traumatized brain.

Expected

ONP-002 Product Development Timeline:

Complete Complete Q1 2026 Start Estimated Q1 2027 start Estimated Q1 2028 start

This

product development plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals.

Validation

and Stability of ONP-002

Certificate of Analysis (COA) was issued by the manufacturer of the drug, indicating that testing methods were standard and include appearance,

identification by 1H NMR (a technique used to determine the structure of organic molecules), identification by Mass Spectroscopy (MS),

optical purity by HPLC, residual solvent analysis, elemental impurities, percent water, and residue on ignition. The manufacturer has

shown both the specifications and the results, indicating that the material supplied passes all criteria. ONP-002 is supplied in pure

form. As such, no excipients are present. Stability studies were performed by storing samples under carefully controlled conditions with

respect to temperature and humidity. The stability testing protocol included storage at 25 °C± 2 °C at 60% relative humidity

± 5% relative humidity for 24 months and 40 °C± 2 °C at 75% relative humidity ± 5% for 18 months. Samples

were pulled at the scheduled time and analyzed for appearance, purity, assay, optical purity, and water content. No changes in ONP-002

were seen.

Intellectual

Property

Patent

applications that concern ONP-002 and the nasal delivery device have been filed as follows:

○ An issued U.S. patent expiration without patent term extension - 9/17/2035.

○ An exemplary issued U.S. patent expiration - 10/19/2042.

ONP-002

Development and Studies

ONP-002

Pre-Clinical Trials

The

ONP-002 drug has completed toxicology studies in rats and dogs. Those studies show that ONP-002 has a large safety margin for its predicted

efficacious dose. In preclinical animal studies, the drug demonstrated rapid and broad biodistribution throughout the brain while simultaneously

reducing swelling, inflammation, and oxidative stress, along with an excellent safety profile.

Results

from the preclinical studies suggest that ONP-002 has an equivalent, and potentially superior, neuroprotective effect compared to related

neurosteroids. The animals treated with the drug post-concussion showed positive behavioral outcomes using various testing platforms

including improved memory and sensory-motor performance, and reduced depression and anxiety-like behaviors.

ONP-002

Induction of Pregnane X Receptor (PXR)

The

induction of the human CYP450 enzymes, CYP2B6, and CYP3A4, by ONP-002, as measured by mRNA expression, was tested in human hepatocytes

from 3 donors at 3 concentrations: 1 μM, 10 μM and 100 μM. Results reflected that ONP-002, through the known PXR-mechanism,

produced a modest induction of CYP3A4, up to 17% of the positive control, and a greater induction of CYP2B6, of up to 59% of the positive

control, both at a concentration of 100 μM. Past data reflected that ONP-001 (entProgesterone) and Progesterone induce the PXR receptor.

Receptor binding studies have been performed showing ONP-002 does not activate the classical Progesterone Receptor.

ONP-002

Animal Studies

All

surgical animals (male Sprague-Dawley rats weighing approximately 250 grams) were anesthetized with an initial isoflurane induction for

4 minutes, the minimum time necessary to sedate the animal. The scalp was shaved and cleaned with isopropanol and betadine. During the

stereotaxic surgery, anesthesia was maintained with isoflurane. A medial incision was made, and the scalp was pulled back over the medial

frontal cortex. A 6mm diameter craniotomy was performed exposing the brain tissue. An electrically controlled injury device using a 5mm

metal impactor was positioned over the exposed brain. An impact speed of 1.6 m/s at a 90-degree angle from vertical was used to produce

an open head injury at a depth of 1mm to create a milder TBI. All treatments were given intranasal (IN) as a liquid solution with a micro

atomizer. Vehicle for all administrations was 22.5% Hydroxy-Propyl-β-cyclodextrin (HPβCD).

Molecular

Studies - Brain tissue was taken from the penumbral region of injury.

Cerebral

Edema

Figure 1, we show that ONP-002 reduces swelling in rats compared to vehicle-treated at 24hours after brain injury by measure of brain

water content through speed-vacuum dehydration and tissue weight comparisons. ONP-002-treated (4mg/kg) and vehicle-treated were compared

to sham which was set at zero. Local edema can occur after mTBI.

Severe

cerebral edema is associated with poor outcomes including increased mortality after mTBI with Second Impact Syndrome (2). *Denotes

significance at p<0.05, n=6

Figure

Inflammation

mTBI

causes vascular and neuronal stress. Microglia and reactive astrocytes infiltrate the areas of injury and release inflammatory mediators

like TNF-alpha. We show that ONP-002 (4mg/kg) reduces TNF-alpha-mediated neuroinflammation in brain tissue of rats compared to vehicle

at 24 hours after mTBI (ELISA).

Pharmacokinetics

and Safety of IN ONP-002 in Dogs

This

pivotal GLP 14-day study used repeat dosing of ONP-002, 3X a day, approximately 4 hours apart, for 14 consecutive days at concentrations

of 0, 3, 10 or 23 mg/mL at a volume of 1ml/nostril to beagle dogs (both nostrils had drug administered). The IN treatment was given as

a liquid solution using a micro atomizer using 22.5% HPβCD as the vehicle. IN ONP-002 dosing revealed that ONP-002 was well tolerated

up to the highest dose of 23mg/ml or 46mg in total per dosing. Clinical observations were limited to increased salivation in dogs which

occurred in a dose-dependent manner. There were no effects on body weight, food consumption, ophthalmic parameters, clinical chemistry,

hematology, or organ weights at any of the doses tested. Microscopic analysis revealed purulent exudates in the nasal turbinate and evidence

of inflammatory infiltrates and fibrin deposition in the lungs. All of these events were classified as mild, reversed during the recovery

period, and did not appear to show any dose dependency. Similar findings were evident in vehicle control treated dogs indicating the

findings were vehicle related. The highest dose of 23mg/ml was thus determined to be the no-observed adverse-effect level (NOAEL), which

is equivalent to a ONP-002 dose of 1.5mg/kg and 2.3mg/kg in male and female dogs, respectively. Testing shows the dose-dependent increase

in plasma exposure of ONP-002 in male and female dogs following IN administration. Plasma exposure levels were similar in males and females

and there did not appear to be any evidence of drug accumulation following multiple doses.

Cardiopulmonary

Safety Pharmacology

The

effect of ONP-002 on the human ether-a-go-go related gene (hERG) tail currents was assessed in a non-Good Laboratory Practice (GLP) study

using manual whole-cell patch clamp. ONP-002 tested at a single concentration of 10μM inhibited hERG tail currents by 42.6% (n=3).

In order to achieve a safety factor of 30-fold between in vitro hERG IC50 and free plasma levels of ONP-002 in clinical studies, Cmax

should not exceed a free drug concentration of 0.33μM (99ng/ml). ONP-002 is 97.2% human plasma protein bound and is estimated to reach

a plasma Cmax of 12.5nM, the highest dose of 0.533mg/kg to be administered in the planned first in human (FIH) study, which provides

a safety factor of 800-fold. A GLP study is planned at Charles River, Inc. and will be performed prior to IND submission.

ONP-002

Clinical Trials

ONP-002

has completed a Phase 1 clinical trial in healthy human subjects showing it is safe and well tolerated.

Safety

studies have established a dosing regimen of 2X/day for fourteen days. The Phase I clinical trial was performed in Melbourne, Australia

with a Contract Research Organization (CRO), Avance Clinical Pty Ltd and Nucleus Network Pty Ltd. The country of Australia provides a

currency exchange advantage and a tax rebate at the end of our fiscal year from the Australian government on all Research and Development

performed in Australia.

The

Phase 1 study was double-blinded, randomized and placebo controlled (3:1, drug: placebo). Phase 1 used a Single Ascending/Multiple Ascending

(SAD/MAD) drug administration design. The SAD component was a 1X treatment (low, medium, or high dose) and the MAD component was a 1X/day

treatment for five consecutive days (low and medium dose). Blood and urine samples were collected at multiple time points for safety

pharmacokinetics. Standard safety monitoring was provided for each body system.

Forty

human subjects (31 males, 9 females) were successfully enrolled in Phase I. The Safety Review Board, made up of medical doctors, has

reviewed the trial data and has determined the drug is safe and well tolerated at all dosing levels.

After

a delay due to a large hospital merger in Australia that included our lead site, we anticipate launching our Phase 2a clinical trials

in Australia in the first quarter of 2026. Phase 2a clinical trials are focused on feasibility metrics and we anticipate that this data

will be important in our clinical trial design and strategy for future U.S. based clinical trials.

anticipate preparing for Phase 2b clinical trials to further evaluate ONP-002’s safety and efficacy. Based on the Phase I data,

we plan to apply for an Investigational New Drug application (IND) with the FDA and conduct a Phase 2b trial in the U.S. Additional non-clinical

studies are planned for 2026 as part of our IND submission strategy.

Business

Development Strategy

Success

in the biopharmaceutical and product development industry relies on the continuous development of novel product candidates. Most product

candidates do not make it past the clinical development stage, which forces companies to look externally for innovation. Accordingly,

we expect, from time to time, to seek strategic opportunities through various forms of business development, which can include strategic

alliances, licensing deals, joint ventures, collaborations, equity or debt-based investments, dispositions, mergers, and acquisitions.

We view these business development activities as a necessary component of our strategies, and we seek to enhance shareholder value by

evaluating business development opportunities both within and complementary to our current business, as well as opportunities that may

be new and separate from the development of our existing product candidates.

Market

Opportunity

are currently focused on applying intranasal drug delivery to the development of therapies for neurological conditions, including mild

traumatic brain injury (“mTBI” or concussion). We believe the treatment of concussion represents a significant unmet medical

need, as there are currently no FDA-approved pharmacological therapies specifically indicated for the treatment of concussion.

believe intranasal delivery may offer certain advantages compared to systemic administration, including non-invasive administration and

the potential for more rapid central nervous system exposure. Systemic administration can present challenges in achieving efficient delivery

of certain therapies to the central nervous system, which we believe present an opportunity for intranasal drug delivery approaches.

Growth

Strategy

the FDA clears or approves our product candidates to be marketed commercially, we intend to enter into agreements with industry partners

or qualified distributors throughout the U.S. We intend to pursue a similar approach if our product candidates are cleared or approved

for marketing outside of the U.S. We intend to require such partners or distributors to pay us an initial license fee, as well as royalties

based on gross sales. Retaining exclusivity is expected to be based on a mutually agreeable semi-annual or quarterly sales minimum. We

also anticipate focusing on international growth because, generally, we believe such international license agreements provide a stronger

path to revenue and earnings than purely domestic products.

Our

objective is to eventually grow revenue through marketing and sales of ONP-002 if it gains regulatory approvals. Although no assurances

can be given, management anticipates company growth from the following areas:

currently have no products authorized for commercial distribution in the U.S., Europe, or any other country. We have development programs

for devices and pharmaceutical drugs, which are in various stages of development. Currently we are only funding the development of ONP-002

which is intended to treat concussion. All of our products require regulatory clearance or approvals, and we cannot begin marketing and

selling our product candidates until we obtain applicable authorizations from the respective regulatory agency.

Government

Regulations

the U.S., foods (including dietary supplements), drugs (including biological products), medical devices, cosmetics, tobacco products

and radiation-emitting products are subject to extensive regulation by the FDA. The FDC Act and other federal and state statutes and

regulations govern, among other things, the manufacture, distribution and sale of these products. These laws and regulations prescribe

criminal and civil penalties that can be assessed, and violation of these laws and regulations can result in enforcement actions by the

FDA and other regulatory agencies.

FDA

Regulation of Drugs - New Drug Approval Process

Pharmaceutical

products are subject to extensive regulation by the FDA. The FDC Act, and other federal and state statutes and regulations, govern, among

other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution,

post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. Failure to comply with applicable

U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending

NDAs or Biologics License Applications (BLAs), warning or untitled letters, product recalls, product seizures, total or partial suspension

of production or distribution, injunctions, fines, civil penalties and criminal prosecution.

Pharmaceutical

product development for a new product or certain changes to an approved product in the U.S. typically involves the following steps before

a biological product or new drug may be marketed in the U.S.:

● submission of an NDA or BLA to the FDA for review;

● FDA approval of the NDA or BLA; and

● payment of user and establishment fees, if applicable.

Satisfaction

of FDA pre-market approval requirements typically takes many years, and the actual time required may vary substantially based upon the

type, complexity and novelty of the product or disease.

Pre-clinical

tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics

and potential safety and efficacy of the product. The conduct of the pre-clinical tests must comply with federal regulations and requirements,

including good laboratory practices. The results of preclinical testing are submitted to the FDA as part of an IND along with other information,

including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long term pre-clinical

tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.

30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA

has neither commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.

Clinical

trials involve the administration of the IND to healthy volunteers or patients under the supervision of a qualified investigator. Clinical

trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with good clinical practice, or GCP, an international

standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators, and monitors;

as well as (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness

criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the

FDA as part of the IND.

The

FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes

that the clinical trial is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial

patients. The trial protocol and informed consent information for patients in clinical trials must also be submitted to an institutional

review board or IRB for approval. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently,

for failure to comply with the IRB’s requirements, or may impose other conditions.

Clinical

trials to support NDAs or BLAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap.

In Phase 1, after the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism,

pharmacokinetics, pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence on effectiveness.

Phase 2 usually involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication,

dosage tolerance, and optimum dosage, and to identify common adverse effects and safety risks. If a compound demonstrates evidence of

effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information

about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit

the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.

In most cases the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug. A single

Phase 3 clinical trial with other confirmatory evidence may be sufficient in rare instances where the trial is a large multicenter trial

demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible

morbidity or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial would be practically

or ethically impossible.

The

length of time and related costs necessary to complete clinical trials varies significantly and may be difficult to predict. Clinical

trial results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. Additional

factors that can cause delay or termination of our clinical trials, or cause the costs of these clinical trials to increase, include:

● delays in approvals from a trial site’s IRB;

● lack of sufficient supplies of the drug candidate for use in clinical trials;

● adverse medical events or side effects in treated patients; and

● lack of effectiveness of the drug candidate being tested.

Any

drug is likely to produce some toxicities or undesirable side effects in animals and in humans when administered at sufficiently high

doses and/or for sufficiently long periods of time. Unacceptable toxicities or side effects may occur at any dose level, and at any time

in the course of animal studies designed to identify unacceptable effects of a drug candidate, known as toxicological studies, or in

clinical trials of our drug candidates. The appearance of any unacceptable toxicity or side effect could cause us or regulatory authorities

to interrupt, limit, delay or abort the development of any of our drug candidates and could ultimately prevent marketing approval by

the FDA or foreign regulatory authorities for any or all targeted indications.

addition, the manufacturer of an investigational drug in a Phase 2 or Phase 3 clinical trial for a serious or life-threatening disease

is required to make available, such as by posting on its website, its policy on evaluating and responding to requests for expanded access.

After

completion of the required clinical testing, an NDA or BLA is prepared and submitted to the FDA. FDA approval of the NDA or BLA is required

before marketing of the product may begin in the U.S. The NDA or the BLA must include the results of all pre-clinical, clinical and other

testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture and controls. The cost of preparing

and submitting an NDA is substantial.

The

FDA has 60 days from its receipt of an NDA or BLA to determine whether the application will be filed based on the agency’s threshold

determination that it is sufficiently complete to permit substantive review. If the NDA or BLA submission is filed, the FDA reviews the

NDA or BLA to determine, among other things, whether the proposed product is safe and effective for its intended use. The FDA has agreed

to certain performance goals in the review of NDAs or BLAs. Most such applications for standard review drug products are reviewed within

ten to twelve months; most applications for priority review drugs are reviewed in six to eight months. Priority review can be applied

to drugs that the FDA determines offer major advances in treatment or provide a treatment where no adequate therapy exists. For biologics,

priority review is further limited to drugs intended to treat a serious or life-threatening disease relative to the currently approved

products. The review process for both standard and priority review may be extended by the FDA for three additional months to consider

certain late-submitted information, or information intended to clarify information already provided in the submission.

The

FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to

an advisory committee – typically a panel that includes clinicians and other experts – for review, evaluation and a recommendation

as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally

follows such recommendations. Before approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance

with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve

the product unless compliance with current Good Manufacturing Processes (cGMPs) is satisfactory and the NDA or BLA contains data that

provide substantial evidence that the drug is safe and effective in the indication studied.

After

the FDA evaluates the NDA or BLA and the manufacturing facilities, it issues either an approval letter or a complete response letter.

A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information,

in order for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction

in a resubmission of the NDA or BLA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in

two or six months depending on the type of information included.

approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. As a condition

of NDA or BLA approval, the FDA may require a risk evaluation and mitigation strategy, or REMS, to help ensure that the benefits of the

drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals, and elements

to assure safe use, or ETASU. ETASU can include, but is not limited to, special training or certification for prescribing or dispensing,

dispensing only under certain circumstances, special monitoring and the use of patient registries. The requirement for a REMS can materially

affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval testing and

surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory

standards is not maintained, or problems are identified following initial marketing.

Changes

to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes

or facilities, require submission and FDA approval of a new NDA or BLA supplement before the change can be implemented. An NDA or BLA

supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same

procedures and actions in reviewing NDA or BLA supplements as it does in reviewing NDAs or BLAs.

The

required testing, data collection, analysis and compilation of an IND and a BLA or NDA are labor intensive and costly and may take a

great deal of time. Tests may have to be redone, or new tests performed in order to comply with FDA requirements. It can take considerable

time (e.g., 5-10 years) and resources to achieve enrollment sufficient to commence such trials and complete Phase 2 or 3 clinical trials.

Moreover, there is no guarantee a product will be approved.

The

Orphan Drug Act provides incentives to manufacturers to develop and market drugs for rare diseases and conditions affecting fewer than

200,000 people in the U.S. at the time of application for orphan drug designation. The first developer to receive FDA marketing approval

for an orphan drug is entitled to a seven-year exclusive marketing period in the U.S. for the orphan drug indication. However, a drug

that the FDA considers to be clinically superior to, or different from, another approved orphan drug, even though for the same indication,

may also obtain approval in the U.S. during the seven-year exclusive marketing period.

Legislation

similar to the Orphan Drug Act has been enacted in other countries outside of the U.S., including the EU. The orphan legislation in the

EU is available for therapies addressing conditions that affect five or fewer out of 10,000 persons, are life-threatening or chronically

debilitating conditions and for which no satisfactory treatment is authorized. The market exclusivity period is for ten years, although

that period can be reduced to six years if, at the end of the fifth year, available evidence establishes that the product does not justify

maintenance of market exclusivity.

Expedited

Development and Review Programs

Under

the FDA Modernization Act of 1997, designation as a Fast-Track product or a breakthrough therapy for a new drug or biological product

means that the FDA will take such actions as are appropriate to The FDA has the authority to facilitate and expedite the development

and review of a drug through various programs, such as fast track designation, breakthrough therapy designation and priority review designation.

Each program may be utilized by the FDA in the context of particular circumstances. For example, fast track designation would generally

be used to facilitate the development and review of a drug that addresses an unmet medical need. Breakthrough therapy designation applies

similarly in cases where a drug demonstrates substantial improvement over existing and available therapies. Priority review designation

suggests the FDA will act on an application within six months of filing.

cannot guarantee that the FDA will grant any of our requests for fast track or breakthrough therapy designations, that any such designations

would affect the time of review or that the FDA will approve the NDA or BLA submitted for any of our drug candidates, whether these designations

are granted or not. Additionally, FDA approval of a fast track/breakthrough product can include restrictions on the product’s use

or distribution (such as permitting use only for specified medical conditions or limiting distribution to physicians or facilities with

special training or experience). Approval of such designated products can be conditioned on additional clinical trials after approval.

Accelerated

approval is also possible in the event a product treats a serious or life-threatening condition and provides a meaningful advantage over

available therapies. Products in this category must also meet a number of additional requirements. While a product may qualify for one

or more of the foregoing programs, the FDA reserves the right to later decide the product no longer qualifies or that the product is

no longer subject to priority regarding its review or approval.

Emergency

Use Authorization

The

FDA also has the authority to grant an Emergency Use Authorization (“EUA”) to allow unapproved medical products to be used

in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved,

and available alternatives, as designated by the U.S. government. An EUA granted by the FDA would permit a drug candidate to be able

to be distributed under the conditions set forth in the EUA prior to FDA approval. Furthermore, the FDA may revoke an EUA for a variety

of reasons, including where it is determined that the underlying health emergency no longer exists or warrants such authorizations.

Pediatric

Information

Under

the Pediatric Research Equity Act, or PREA, NDAs, BLAs or supplements to NDAs or BLAs must contain data to assess the safety and effectiveness

of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric

subpopulation for which the drug is safe and effective. The FDA may grant full or partial waivers, or deferrals, for submission of data.

Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation has been granted,

except a product with a new active ingredient that is a molecularly targeted cancer product intended for the treatment of an adult cancer

and directed at a molecular target determined by FDA to be substantially relevant to the growth or progression of a pediatric cancer

that is subject to an NDA submitted on or after August 18, 2020.

The

Best Pharmaceuticals for Children Act, (“BPCA”), provides NDA holders a six-month extension of any exclusivity – patent

or non-patent – for a drug if certain conditions are met. For BLAs, the BPCA provides a six-month extension for non-patent exclusivity

if certain conditions are met. Conditions for exclusivity include the FDA’s determination that information relating to the use

of a new drug in the pediatric population may produce health benefits in that population, the FDA making a written request for pediatric

studies, and the applicant agreeing to perform, and reporting on, the requested studies within the statutory timeframe. Applications

under the BPCA are treated as priority applications, with all of the benefits that designation confers.

Disclosure

of Clinical Trial Information

OGEN US Equity

OGEN · 10-K · period ended 2025-12-31

ITEM 1. BUSINESS 1

ITEM 1A. RISK FACTORS 21

ITEM 1B. UNRESOLVED STAFF COMMENTS 54

ITEM 1C. CYBERSECURITY 54

ITEM 2. PROPERTIES 55

ITEM 3. LEGAL PROCEEDINGS 55

ITEM 4. MINE SAFETY DISCLOSURES 55

ITEM 6. RESERVED 56

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 63

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 63

ITEM 9A. CONTROLS AND PROCEDURES 63

ITEM 9B. OTHER INFORMATION 64

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 64

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 65

ITEM 11. EXECUTIVE COMPENSATION 68

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 82

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 83

OGEN US Equity☆

OGEN · 10-K · period ended 2025-12-31

ITEM 1. BUSINESS 1

ITEM 1A. RISK FACTORS 21

ITEM 1B. UNRESOLVED STAFF COMMENTS 54

ITEM 1C. CYBERSECURITY 54

ITEM 2. PROPERTIES 55

ITEM 3. LEGAL PROCEEDINGS 55

ITEM 4. MINE SAFETY DISCLOSURES 55

ITEM 6. RESERVED 56

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 63

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 63

ITEM 9A. CONTROLS AND PROCEDURES 63

ITEM 9B. OTHER INFORMATION 64

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 64

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 65

ITEM 11. EXECUTIVE COMPENSATION 68

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 82

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 83

OGEN US Equity