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Item 1. Business

2026-03-31 compared with 2025-04-22 · 376 added, 211 removed, 1227 unchanged (32% of the section changed)

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Subsidiary candidates are companies that

are either already existing entities or new companies formed in connection with acquiring or licensing existing assets from pharmaceutical

are either already existing entities or new companies formed in connection with acquiring or licensing existing assets from industry or

We expect to attract industry partners either as co-investors or through technology licensing deals and may raise capital

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T-cell immunotherapies based on a live attenuated, safe, orally, available bacterial vaccine strain, genetically modified to develop and elicit patients’ cytotoxic T-cells against specific pre-defined targets

Platform integrating different protein domain sequences linking into a Design augmented recombinant biologic with enhanced biological functionality

Platform integrating different protein domain sequences linking into a Design-augmented (DA) recombinant biologic with enhanced biological functionality for bone and cartilage regeneration

Neurovascular surgical devices

the Company portfolio

company snapshot.

the Company subsidiary portfolio snapshot.

Intellectual Property Overview

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AU, CA, CN, EP, IN, JP, KR, US, ZA

VXM01 – dosing (2)

WO 2014/005683, DNA Vaccine for Use in Pancreatic Cancer Patients

VXM01 – dosing (2) WO 2014/005683, DNA Vaccine

for Use in Pancreatic Cancer Patients

AU, CN, EP, JP, KR, US, ZA

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Composition of Matter

Activin/bmp7 chimeras:

super-active sab704 and sab715, and their respective

noggin-sensitized variants, nab704 and nab715;

WO2020/101366

Composition of Matter

Individual patents are in force for varying periods of time, depending

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Vaximm Corporate Overview

Vaximm is developing innovative oral immunotherapies for the treatment

of cancer and immunological disorders.

Based on over 20 years of research, Vaximm’s customizable immunotherapy platform has

the potential to be efficiently and effectively adapted to treat various diseases and address specific patient needs.

Vaximm currently

has three clinical and pre-clinical drug candidates targeting diseases ranging from glioblastoma to gastrointestinal stromal tumor

to ocular diseases.

Vaximm’s flagship asset, VXM01, is a late clinical-stage (NCT037500701)

immuno-oncology candidate for glioblastoma, which early-stage clinical trials suggest may be a potentially specific and effective

VXM01 has been granted Orphan Drug Designation by the U.S.

Food and Drug Administration (FDA) and European Medicines Agency

(EMA) for both glioblastoma and pancreatic cancer on August 31, 2017 from FDA and August 23, 2017 from EMA.

An Orphan Drug

Designation will permit Vaximm to receive additional years of market exclusivity upon regulatory approval, which provides a significant

competitive advantage.

Vaximm is developing innovative oral T-cell immunotherapies for the

treatment of disorders that require the safe and targeted elimination of specific cell populations.

neoplasms, other proliferative

diseases, chronic infections).

Based on over 20 years of research, Vaximm’s customizable immunotherapy platform has the potential

to be efficiently and effectively adapted to treat various diseases and address specific patient needs.

Vaximm currently has three clinical

and pre-clinical drug candidates targeting diseases ranging from glioblastoma to gastrointestinal stromal tumor to ocular diseases.

Vaximm holds the only clinically tested oral cancer vaccine with proven safety and demonstrated efficacy

Vaximm’s flagship asset, VXM01, is a late

clinical-stage (NCT037500701) immuno-oncology candidate for glioblastoma, which early-stage clinical trials

(NCT02718443 and NCT01486329) suggest may be a potentially specific and effective treatment.

VXM01 has been granted Orphan Drug

Designation by the U.S.

Food and Drug Administration (FDA) and European Medicines Agency (EMA) for both glioblastoma and

pancreatic cancer on August 31, 2017 from FDA and August 23, 2017 from EMA.

An Orphan Drug Designation will permit

Vaximm to receive additional years of market exclusivity upon regulatory approval, which provides a significant competitive

See “ Government Regulation — Orphan Drug Designation and Exclusivity .” “

While VXM01 moves into planned phase 2 clinical trials, we are continuing to advance Vaximm’s other preclinical candidates in investigational

Based on evolving science, Vaximm is developing the VXM01 v 2.0.

While meant to improve efficacy, it leverages the proven vector

safety data from VXM01 to move into late-stage development at speed.

While VXM01 (including version 2.0) moves into planned phase 2, phase

2/3 clinical trials, we are continuing to evaluate Vaximm’s other preclinical candidates for further development in investigational

new drug (IND)-enabling studies.

A preclinical-stage oral T-cell vaccine

targeting mesothelin

A preclinical-stage oral T-cell vaccine

targeting Wilms Tumor Protein (WT1)

A preclinical-stage oral T-cell vaccine

targeting CEA(Carcinoembryonic antigen)

A preclinical-stage oral T-cell vaccine

targeting PD-L1

Importantly, the live, attenuated S.

typhi strain Ty21a, presents

a proprietary platform for inducing an immune response to other antigens beyond the here chosen VEGFR-2, such as Carcinoembryonic Antigen

(CEA), Fibroblast Activation Protein (FAP) expressed in the tumor stroma, or Multiple Drug Resistance 1 (MDR-1).

We have since tested

in preclinical models a variety of other antigens with success.

A preclinical-stage oral T-cell vaccine targeting mesothelin (MSLN)

A preclinical-stage oral T-cell vaccine targeting Wilms Tumor Protein (WT1)

A preclinical-stage oral T-cell vaccine targeting CEA(Carcinoembryonic antigen)

A preclinical-stage oral T-cell vaccine targeting PD-L1 (Programmed death-ligand 1)

These products are currently undergoing preclinical studies to evaluate

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from preclinical to late-stage clinical trials and developed a pipeline of other preclinical therapeutic candidates, other than receiving

Orphan Drug Designation for VSMO1, Vaximm has limited experience in applying for regulatory or marketing approval for any of its product

As Vaximm continues to advance its line of oral immunotherapies, it will remain flexible and opportunistic to explore partnering

Orphan Drug Designation for VXMO1, Vaximm has limited experience in applying for regulatory or marketing approval for any of its product

candidates specifically.

That said, this experience exists within the team.

As Vaximm continues to advance its line of oral immunotherapies,

it will remain flexible and opportunistic to explore partnering options.

Current approaches to targeted immunotherapies have various limitations,

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Vaximm’s lead product candidate, VXM01, targets the tumor vasculature and specific tumor antigens.

VXM01 is currently being evaluated

in a Phase 2 clinical trial in Europe for the treatment of recurrent glioblastoma.

It differs decidedly from other

vaccine approaches, since VXM01 does not have to overcome local immune suppression/encapsulation.

The target, further, does not allow

for mutations and immune escape.

VXM01 and the underlying proprietary platform, further, has the potential to target multiple indications,

even beyond oncology.

VXM01 has recently completed a Phase 2 clinical trial in Europe

for the treatment of recurrent glioblastoma, where activity has been observed to date.

Vaximm also plans to initiate a new clinical trial

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Identify novel tumor-specific antigens:

Vaximm will leverage

its expertise in antigen discovery to identify new tumor-specific antigens that can be targeted by Vaximm’s platform.

Conduct preclinical studies with the FDA’s good laboratory

practice (“GLP” regulations):

Before testing any drug or biological product candidate in humans, the product candidate must

undergo rigorous pre-clinical testing.

The pre-clinical developmental stage generally involves laboratory evaluations of drug

chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to assess the potential for adverse events

and, in some cases, to establish a rationale for therapeutic use.

The conduct of pre-clinical studies is subject to federal regulations

and requirements, including GLP regulations for safety/toxicology studies.

Vaximm will perform preclinical studies to evaluate the safety,

immunogenicity, and anti-tumor efficacy of its oral cancer vaccine candidates in line with the GLP regulations that the FDA requires.

Vaximm will leverage its

expertise in antigen discovery to identify new tumor-specific antigens that can be targeted by Vaximm’s platform.

include, as per precedent, targets which are expressed by cancer supporting tissue.

The safety profile and the mode of action of the platform make it a

prime candidate for combination with standard of care treatments.

Thus, currently envisioned clinical development will initially focus

on add-on trials, avoiding initially combinations of non-approved assets.

This presents a straight forward way to approval.

Conduct preclinical studies with the FDA’s good laboratory practice (“GLP” regulations):

Before testing any drug or biological product candidate in humans, the product candidate must undergo rigorous pre-clinical testing.

The pre-clinical developmental stage generally involves laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to assess the potential for adverse events and, in some cases, to establish a rationale for therapeutic use.

The conduct of pre-clinical studies is subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies.

Vaximm will perform preclinical studies to evaluate the safety, immunogenicity, and anti-tumor efficacy of its oral cancer vaccine candidates in line with the GLP regulations that the FDA requires.

File an Investigational New Drug (IND) application:

successful completion of preclinical studies, Vaximm will submit an IND application to regulatory authorities such as the FDA.

is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be allowed to

proceed by the FDA before human clinical trials may begin.

This submission includes all relevant data from preclinical studies and outlines

the proposed clinical trial protocols.

The IND review period typically takes 30 days, during which the regulatory agency evaluates

the submission to ensure the safety of proceeding to human trials.

Upon the successful completion of preclinical studies, Vaximm will submit an IND application to regulatory authorities such as the FDA.

IND is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be allowed to proceed by the FDA before human clinical trials may begin.

This submission includes all relevant data from preclinical studies and outlines the proposed clinical trial protocols.

The IND review period typically takes 30 days, during which the regulatory agency evaluates the submission to ensure the safety of proceeding to human trials.

Initiate clinical trials:

Based on the preclinical data and

IND approval, the company will design and conduct additional Phase 1/2 clinical trials to assess the safety, tolerability, and preliminary

efficacy of its oral cancer vaccines in other cancer indications.

Based on the preclinical data and IND approval, the company will design and conduct additional Phase 2 clinical trials to assess the safety, tolerability, and preliminary efficacy of its oral cancer vaccines in other cancer indications.

Conduct Phase 3 clinical trials:

Phase 3 trials are

large-scale, randomized, controlled studies designed to provide additional supporting evidence of the efficacy and safety of therapeutic

These trials typically involve hundreds to thousands of patients and are conducted at multiple sites worldwide.

work closely with clinical investigators, regulatory authorities, and patient advocacy groups to design and execute Phase 3 clinical

trials for its oral cancer vaccine candidates.

Phase 3 trials are large-scale, randomized, controlled studies designed to provide additional supporting evidence of the efficacy and safety of therapeutic candidates.

These trials typically involve hundreds of patients and are conducted at multiple sites worldwide.

Vaximm will work closely with clinical investigators, regulatory authorities, partners and patient advocacy groups to design and execute Phase 3 clinical trials for its oral cancer vaccine candidates.

Seek regulatory approval:

Following the successful completion

of Phase 3 clinical trials, the result of the pre-clinical studies and clinical trials, together with detailed information

relating to the product’s chemistry, manufacture, controls, and proposed labeling, among other things, are submitted to authorities,

such as the FDA or EMA.

Following the successful completion of Phase 3 clinical trials, the result of the pre-clinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls, and proposed labeling, among other things, are submitted to authorities, such as the FDA or EMA.

This stage is known as the New Drug Application (NDA) review.

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any data from studies that may have been conducted in other countries, institutional review board compliance information and directions

Vaximm has that information largely readily available due to past work.

Especially, there seems no need for expensive and long-lasting

animal safety studies.

Once each authority such as FDA or EMA receives an NDA, the review

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The process includes the following:

● Each member of the review team conducts a full review of his

or her section of the application.

For example, the medical officer and the statistician review clinical data, while a pharmacologist

reviews the data from animal studies.

Each member of the review team conducts a full review of his or her section of the application.

For example, the medical officer and the statistician review clinical data, while a pharmacologist reviews the data from animal studies.

Within each technical discipline represented on the team, there is also a supervisory review.

● FDA or EMA inspectors travel to clinical study sites to conduct

a routine inspection.

All expertise needed with a proven track record are available within the team

FDA or EMA inspectors travel to clinical study sites to conduct a routine inspection.

The Agency looks for evidence of fabrication, manipulation, or withholding of data.

● The project manager assembles all individual reviews and other

documents, such as the inspection report, into an “action package.” This document becomes the record for NDA review.

review team issues a recommendation, and a senior official makes a decision.

The project manager assembles all individual reviews and other documents, such as the inspection report, into an “action package.” This document becomes the record for NDA review.

The review team issues a recommendation, and a senior official makes a decision.

In cases where FDA or EMA determines that a drug has been shown to

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Antigen discovery and vaccine formulation:

● Preclinical studies:

● IND filing and review:

● Phase 1/2 clinical trials:

● Phase 3 clinical trials:

● Regulatory approval (including NDA review):

Based on this timeline, Vaximm anticipates that its first oral cancer

(This step is not necessary for VXM01

including 2.0, but may have to in part be executed for new targets)

● Preclinical

filing and review:

clinical trials:

approval (including NDA review):

Based on this timeline, Vaximm anticipates that its next oral cancer

vaccine candidate beyond VXM01 could enter clinical trials within the next 3-5 years, with potential regulatory approval in

the next 7-9 years.

less than 7 years.

In case of the improved version of VXM01, these timelines are expected

to be significantly shorter (about 4years).

Clinical Trials

Overview of VXM01 clinical trial

A phase1 clinical trial of VXM01 in Glioblastoma was initiated in May 2016

(ClinicalTrials.gov ID:

VXM01 was clinically tested in two trials in advanced pancreatic cancer

and in Glioblastoma:

Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer (NCT01486329)

Phase I Pilot Study in Patients With Operable Recurrence of a Glioblastoma (NCT02718443)

In both studies, VXM01 was found to be extremely safe and found to

consistently elicit the expected immune response including biomarkers and indication of efficacy.

A randomized, double blinded, placebo phase 1/2 trial in pancreatic carcinoma (NCT01486329):

VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced,

Inoperable and Stage IV Pancreatic Cancer.

NCT01486329 was a randomized, placebo-controlled, double-blinded

dose-escalation study included a total of 72 treated patients with locally advanced and stage IV pancreatic cancer.

received in this trial VXM01 or placebo (S.

typhi carrying a non-coding DNA plasmid) in addition to gemcitabine as standard of care.

In addition to safety as primary endpoint, the VXM01-specific immune reaction, as well as clinical response parameters were

After the initial doses, patients received up to six monthly boost vaccinations, or placebo treatment.

Vaccinations were

applied orally, and concomitant treatment with standard-of-care gem-citabine during the priming phase (first 4 weekly doses):

● Part 1 (n=45, 5 dose levels) initiation treatment only in

the first week on days 1, 3, 5, and 7 at doses ranging from 106 colony forming units (CFU) up to 1010 CFU of VXM01 or placebo (2:1 randomization).

● Part 2 (n=27, 2 dose levels) at two alternative doses of

either 106 colony-forming units (CFU)or 107 CFU with up to 6 monthly boosts after initiation treatment.

Immune monitoring involved interferon-gamma

(IFN-훾) ELIspot analysis with long overlapping peptides spanning the entire VEGFR-2 sequence.

(Designation:

VXM01 has received

orphan drug designation from the U.S.

Food and Drug Administration (FDA) and the European Commission.

This trial was completed at the University of Heidelberg and the German

Cancer Research Center (DKFZ).

Overall survival (all comers):

Importantly, target specific T cell activation over placebo was noted

in both, periphery and tumor tissue.

Part 1, T cell response over placebo:

Activation was noted in both, subjects with and without pre-dosing

existing immune response

Boosting after 40 days sustained and increased the immune response:

There was encouraging survival in subjects boosted in part 2 with bad

prognosis based on CA-19-9, status, extend of disease.

Subgroup analysis “bad prognosis”:

The effect gets more pronounced when looking at patients with successful

immune induction at prime:

Observed pharmacodynamic effects in VXM01 treatment group vs.

● a decrease in tumor perfusion,

● increase in serum collagen,

● mild elevation in blood pressure,

● mild drop in thrombo-cyte, leukocyte and lymphocyte counts.

All of which are indictive of successful vessel targeting and ratification.

For example, increased blood pressure in patients treated with VXM01 over placebo indicates blood vessel rarefication.

Increase of VEGF-A and collagen IV (indicator of vessel destruction)

after vaccination further supported the observed vaccination effects on tumor perfusion, particularly since we observed a significant

inverse correlation between collagen IV serum levels and alterations of tumor perfusion after the vaccination.

DCE-MRI was employed to assess tumor perfusion.

After 38 days, tumor

perfusion as 18% reduced in the VXM01 subjects while unchanged in placebo treated patients

In conclusion, VXM01 elicits a productive, complex

VEGFR-2-specific effector T-cell response in patients with pancreatic cancer that correlates with anti- angiogenic activity and has

a favorable safety profile.

Changes indicative of anti-angiogenic efficacy in tumor perfusion, serum biomarkers, and blood pressure

in VXM01 treated patients but not in the control arm were recorded.

Importantly, no safety concerns were noted

Trial design end results are published in:

AG, Lubenau H, Mikus G, Knebel P, Hohmann N, Leowardi C, Beckhove P, Akhisaroglu M, Ge Y, Springer M, Grenacher L, Buchler MW, Koch M,

Weitz J, Haefeli WE, Schmitz-Winnenthal FH.

Double-blind, placebo-controlled first in human study to investigate an oral vaccine aimed

to elicit an immune reaction against the VEGF-Receptor 2 in patients with stage IV and locally advanced pancreatic cancer.

2012 Aug 20;12:361.

● Schmitz-Winnenthal

FH, Hohmann N, Niethammer AG, Friedrich T, Lubenau H, Springer M, Breiner KM, Mikus G, Weitz J, Ulrich A, Buechler MW, Pianka F, Klaiber

U, Diener M, Leowardi C, Schimmack S, Sisic L, Keller AV, Koc R, Springfeld C, Knebel P, Schmidt T, Ge Y, Bucur M, Stamova S, Podola

L, Haefeli WE, Grenacher L, Beckhove P.

Anti-angiogenic activity of VXM01, an oral T-cell vaccine against VEGF receptor 2, in patients

with advanced pancreatic cancer:

A randomized, placebo-controlled, phase 1 trial.

Oncoimmunology.

2015 Mar 16;4(4):

A phase1 clinical trial of VXM01 in Glioblastoma was initiated in May 2016 (ClinicalTrials.gov ID:

NCT02718443).

The trial was conducted at the Neurology Clinic and National Center for Tumor Diseases in Heidelberg,

Germany, and the principal investigator is Dr.

Wolfgang Wick, MD, who is a professor at the Neurology Clinic and National Center

for Tumor Diseases.

trial was conducted at the Neurology Clinic and National Center for Tumor Diseases in Heidelberg, Germany, and the principal investigator

Wolfgang Wick, MD, who is a professor at the Neurology Clinic and National Center for Tumor Diseases.

The phase I clinical trial was evaluated for 14 patients with

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https://ec.europa.eu/health/documents/community-register/html/o1909.htm

As a next step, on November 21, 2018, a combination study of

VXM01 and anti-PD-L1 checkpoint inhibitor avelumab in 28 patients with relapsed glioblastoma began (ClinicalTrials.gov ID NCT03750071).

As a next step, on November 21, 2018, a combination study of VXM01

and anti-PD-L1 checkpoint inhibitor avelumab in 28 patients with relapsed glioblastoma began (ClinicalTrials.gov ID NCT03750071 ).

The trial included 25 patients with non-resectable tumors and 3 with resectable tumors.

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Wolfgang Wick, the principal investigator for the Phase I

clinical trial, also conducted this combination study.

clinical trial and also a key opinion leader in the field of brain malignancies, also conducted this combination study.

He will remain

principal investigator for future trials.

This Phase I/II clinical trial was not sized or designed to yield

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Initiation of such trials is planned for 2026.

VXM01 Phase I clinical trial — Patient selection

That said, the data to date shows promising responses, including as single

agent, having generated considerable interest in the field at the time.

VXM01 Phase 1/2 clinical trial — Patient selection

Patients were selected by a third-party clinical trial provider, each

of whom met the following criteria:

anaplastic astrocytoma (WHO Grade III)

or glioblastoma (WHO Grade IV) located above the tentorium cerebelli in the brain.

anaplastic astrocytoma (WHO Grade III) or glioblastoma (WHO Grade IV) located above the tentorium cerebelli in the brain.

18 years or older.

men or women who were post-menopausal for

at least 2 years or surgically sterile.

men or women who were post-menopausal for at least 2 years or surgically sterile.

Disease progression:

evidence of tumor growth

after at least one treatment regimen containing radiation and temozolomide chemotherapy.

evidence of tumor growth after at least one treatment regimen containing radiation and temozolomide chemotherapy.

Resectable tumor:

eligible for a repeat surgery

to remove the tumor, with the surgery able to be delayed for 30 days.

eligible for a repeat surgery to remove the tumor, with the surgery able to be delayed for 30 days.

General health:

good bone marrow, liver, and

kidney function (as determined by blood and urine tests);

good bone marrow, liver, and kidney function (as determined by blood and urine tests);

able to undergo MRI scans;

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No recent clinical trials:

no participation in

another clinical trial within 30 days before screening.

no participation in another clinical trial within 30 days before screening.

No specific infections:

negative test results

for Hepatitis B, Hepatitis C, and HIV.

negative test results for Hepatitis B, Hepatitis C, and HIV.

No interfering conditions:

no other medical or

social conditions that might interfere with the study or make it unsafe for the patient to participate.

no other medical or social conditions that might interfere with the study or make it unsafe for the patient to participate.

The study included 14 white patients with a mean age of 56.8 years.

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10 6 CFU dose group.

VXM01 phase I clinical trial — Immune response

VXM01 phase 1/2 clinical trial — Immune response

The effect of VXM01 was explored by evaluating the VEGFR-2 specific

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of whom met the following criteria:

confirmed glioblastoma (WHO Grade IV)

located above the tentorium cerebelli in the brain.

confirmed glioblastoma (WHO Grade IV) located above the tentorium cerebelli in the brain.

Disease progression:

evidence of tumor growth

after receiving standard treatment with radiation and temozolomide chemotherapy.

evidence of tumor growth after receiving standard treatment with radiation and temozolomide chemotherapy.

Prior treatment:

completion of radiotherapy at

least 3 months before entering the trial.

completion of radiotherapy at least 3 months before entering the trial.

Resectable tumors (subset of patients):

for a repeat surgery to remove the tumor, with the surgery able to be delayed for 30 days.

eligible for a repeat surgery to remove the tumor, with the surgery able to be delayed for 30 days.

General health:

good bone marrow, liver, and

kidney function;

good bone marrow, liver, and kidney function;

able to undergo MRI scans;

no active serious infections;

and a Karnofsky performance status of 70 or higher (meaning

they could mostly care for themselves).

and a Karnofsky performance status of 70 or higher (meaning they could mostly care for themselves).

Tumor samples:

availability of tumor tissue for

availability of tumor tissue for analysis.

men were eligible.

Women had to be post-menopausal or

surgically sterile due to a lack of safety data on the vaccine’s potential impact on reproduction.

Women had to be post-menopausal or surgically sterile due to a lack of safety data on the vaccine’s potential impact on reproduction.

With these criteria, the trial recruited 25 patients with non-resectable tumors

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Overall, 12 of 28 patients (42.9%, all in the 10 7 CFU/mL

non-resctable group) had a VEGFR-2 specific T cell response classified as negative for all peptides at all time points tested.

non-resectable group) had a VEGFR-2 specific T cell response classified as negative for all peptides at all time points tested.

The VEGFR-2 specific T cell response was decreased on Day 21 compared with baseline in 6 patients, was increased in 4 patients (all

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independently of the patient’s underlying condition, thus it was not reported as TLT.

Four patients experienced a total of 5 (five)

immune-related AEs (irAEs).

These immune-related AEs included hypothyroidism, autoimmune thyroiditis, fatigue, and the aforementioned

rheumatoid arthritis.

As with other reported events, these immune-related AEs were assessed and determined to be unrelated to VXM01

administration.

Four patients experienced a total of

5 (five) immune-related AEs (irAEs).

These immune-related AEs included hypothyroidism, autoimmune thyroiditis, fatigue,

and the aforementioned rheumatoid arthritis.

As with other reported events, these immune-related AEs were assessed and determined

to be unrelated to VXM01 administration.

Adverse Event Category

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and slow biodegradation, it enables rapid initial bone bonding and long-term support dynamics.

DRT-102 pre-clinical study for toxicity measurement in animal

DRT-102 pre-clinical study for toxicity measurement in

animal models

The toxicity test of DRT-102 was conducted with multiple institutions

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Inclusion Criteria:

(1) Age between 30-80 years

(2) Patients requiring one-level posterior

decompression and fusion between L1 and S1 due to severe spinal stenosis, spondylolisthesis, spondylosis, or retrolisthesis.

(1) Age between 30-80 years old.

(2) Patients requiring one-level posterior decompression

and fusion between L1 and S1 due to severe spinal stenosis, spondylolisthesis, spondylosis, or retrolisthesis.

Exclusion Criteria:

(1) Average spine T-score< -2.5

on dual-energy X-ray absorptiometry (DEXA),

(1) Average spine T-score< -2.5 on dual-energy X-ray absorptiometry

(2) History of cancer,

(3) Patient unable to discontinue anticoagulation

(4) Female patients of childbearing

(3) Patient unable to discontinue anticoagulation therapy,

(4) Female patients of childbearing potential,

(5) Patients testing positive for DRT-102 antibody,

(6) Specific conditions, including

psychological problems.

(6) Specific conditions, including psychological problems.

Patients were regularly followed up at 2, 12, 24 and 48 weeks

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The criteria for determining bone fusion were as follows:

Formation of continuous

trabeculation between the adjacent vertebral body and the graft bone.

Evidence of remodeling

between the adjacent vertebral body and the graft bone.

Absence of radiolucent

areas between the adjacent vertebral body and the graft bone.

Formation of continuous trabeculation between the

adjacent vertebral body and the graft bone.

Evidence of remodeling between the adjacent vertebral

body and the graft bone.

Absence of radiolucent areas between the adjacent

vertebral body and the graft bone.

Fusion was determined successful if at least two of the criteria (a,

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criteria are satisfied:

Continuous trabeculation

Continuous trabeculation formation

Evidence of bone remodeling

Absence of radiolucent

Absence of radiolucent areas

[Bone Fusion Rate Based on CT Scans

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Evaluation Criteria

Formation of bridging

Absence of bone spurs

connecting the two vertebrae at the surgical site.

Formation of bridging callus

Absence of bone spurs connecting the two vertebrae

at the surgical site.

Control Group

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decreases to 0.026, indicating stronger statistical evidence of the difference in success rates between the control and test groups.

Finally, in the largest sample size of 60 patients, the p-value reaches 0.002, demonstrating a statistically significant difference.

Throughout the analysis, the test group outperformed the control group in success rates.

in the largest sample size of 60 patients, the p-value reaches 0.002, demonstrating a statistically significant difference.

the analysis, the test group outperformed the control group in success rates.

Development plans for DRT-101 and DRT-102

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Darnatein’s strategy generally involves the following key steps:

Identify novel drug

candidate for cartilage- and bone-degenerative disorders:

Darnatein will leverage its expert knowledge and experience in tissue regenerative

medicine to identify new cartilage- and bone-degenerative disorders that can be targeted by Darnatein’s DRT-101 and DRT-102 platforms.

Conduct preclinical

studies with the FDA’s good laboratory practice (“GLP”) regulations:

Before testing any drug or biological product candidate

in humans, the product candidate must undergo rigorous pre-clinical testing.

The pre-clinical developmental stage generally

involves laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to

assess the potential for adverse events and, in some cases, to establish a rationale for therapeutic use.

The conduct of pre-clinical studies

is subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies.

Darnatein will first perform

preclinical studies to evaluate the safety, immunogenicity, and efficacy of regenerating the new target tissue candidates.

File an Investigational

New Drug (IND) application:

Upon the successful completion of preclinical studies, Darnatein will submit an IND application to regulatory

authorities such as the FDA.

IND is a request for authorization from the FDA to ship an investigation product and then administer

it to humans and must be allowed to proceed by the FDA before human clinical trials may begin.

This submission includes all relevant data

from preclinical studies and outlines the proposed clinical trial protocols.

The IND review period typically takes 30 days, during

which the regulatory agency evaluates the submission to ensure the safety of proceeding to human trials.

Identify novel drug candidate for cartilage- and bone-degenerative disorders:

Darnatein will leverage its expert knowledge and experience in tissue regenerative medicine to identify new cartilage- and bone-degenerative disorders

that can be targeted by Darnatein’s DRT-101 and DRT-102 platforms.

Conduct preclinical studies with the FDA’s good

laboratory practice (“GLP”) regulations:

Before testing any drug or biological product candidate in humans, the product candidate

must undergo rigorous pre-clinical testing.

The pre-clinical developmental stage generally involves laboratory evaluations of

drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to assess the potential for adverse events

and, in some cases, to establish a rationale for therapeutic use.

The conduct of pre-clinical studies is subject to federal regulations

and requirements, including GLP regulations for safety/toxicology studies.

Darnatein will first perform preclinical studies to evaluate

the safety, immunogenicity, and efficacy of regenerating the new target tissue candidates.

File an Investigational New Drug (IND) application:

Upon the successful completion of preclinical studies, Darnatein will submit an IND application to regulatory authorities such as the

IND is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be

allowed to proceed by the FDA before human clinical trials may begin.

This submission includes all relevant data from preclinical studies

and outlines the proposed clinical trial protocols.

The IND review period typically takes 30 days, during which the regulatory agency

evaluates the submission to ensure the safety of proceeding to human trials.

Initiate clinical trials:

Based on the preclinical data, Darnatein will design and conduct additional Phase 1 clinical trials to assess the safety, tolerability,

and preliminary efficacy of its regeneration of those new tissue candidates.

Conduct Phase 2

and Phase 3 clinical trials:

Phase 2 trials are designed to determine if the new treatment has sufficiently promising efficacy

to warrant further investigation in a large-scale randomized phase 3 trial, as well as to further assess safety.

These studies

usually involve a few hundred patients.

Phase 2 trials also generate insights on adverse events and their management, the diseases

in which the treatment is effective, and the best regimen for future use in a later phase, depending on the trial design.

Based on the preclinical

data, Darnatein will design and conduct additional Phase 1 clinical trials to assess the safety, tolerability, and preliminary efficacy

of its regeneration of those new tissue candidates.

Conduct Phase 2 and Phase 3 clinical trials:

Phase 2 trials are designed to determine if the new treatment has sufficiently promising efficacy to warrant further investigation

in a large-scale randomized phase 3 trial, as well as to further assess safety.

These studies usually involve a few hundred

Phase 2 trials also generate insights on adverse events and their management, the diseases in which the treatment is effective,

and the best regimen for future use in a later phase, depending on the trial design.

Phase 3 trials are large-scale, randomized, controlled

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Seek regulatory approval:

Following the successful completion of Phase 3 clinical trials, the result of the pre-clinical studies and clinical trials,

together with detailed information relating to the product’s chemistry, manufacture, controls, and proposed labeling, among other

things, are submitted to authorities, such as the FDA or EMA.

Following the successful

completion of Phase 3 clinical trials, the result of the pre-clinical studies and clinical trials, together with detailed information

relating to the product’s chemistry, manufacture, controls, and proposed labeling, among other things, are submitted to authorities,

such as the FDA or EMA.

This stage is known as the New Drug Application (NDA) review.

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Under Examination

201980075594.3

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neuro-intervention medical device equipment manufacturers, as well as expand sales of products offered by companies it currently

Strategic Evolution into a Healthcare 4PL Platform

As described above, RMC has historically operated as a medical device

importer and distributor in Korea with a primary focus on the neuro-intervention field.

However, following a comprehensive strategic review,

the management has determined to transform RMC into a fourth-party logistics (“4PL”) platform for the Korean healthcare supply

chain — a strategic evolution that we view as a significant new growth engine for the consolidated group and a material driver of

revenue growth through 2030.

Industry Context and Market Opportunity

The Korean medical device import and distribution sector is under material

structural stress, driven by two converging dynamics:

● Foreign exchange pressure:

Import purchase obligations are predominantly USD-denominated, while distributor revenues are generated

Sustained KRW depreciation has materially increased the local currency cost of Minimum Purchase Guarantee (“MPG”) commitments

to global manufacturers, compressing margins and straining liquidity across the independent distributor base.

● Working capital mismatch:

Large university hospitals — the dominant demand-side buyers — typically remit payment up to

six months after device delivery, while receiving National Health Insurance Service (“NHIS”) reimbursement within approximately

two weeks of claim filing.

Independent distributors are required to finance this five-to-six month A/R gap without adequate access to

institutional capital.

These dynamics have produced a class of financially constrained distributors

actively seeking to exit their Korea agency mandates, import licenses, and MPG obligations — a dislocation management believes presents

RMC with a compelling and time-sensitive consolidation opportunity.

RMC’s targeted 4PL product categories span eleven identified product

lines with a combined total addressable market (“TAM”) estimated at approximately KRW 159.9 billion (~$110.7 million) .

Management notes that this estimate reflects a conservative, narrowly scoped assumption based on RMC’s historical neurointervention focus,

representing approximately 2.3% of total Korean medical device imports of ~USD 4.88 billion (Korean Medical Device Association, 2022).

The Company intends to revisit and update this TAM as RMC establishes a presence in product categories beyond its current core market.

RMC 4PL Business Model

RMC’s 4PL model addresses the structural pain points above by positioning

the Company as a financially capable consolidator and central platform across the Korean medical device supply chain, built on three core

capabilities:

● Mandate Acquisition:

RMC assumes Korea agency mandates, import licenses, and MPG obligations from financially distressed independent

distributors, consolidating a historically fragmented and undercapitalized segment of the supply chain.

● Working Capital Intermediation:

Leveraging OSR Holdings’ NASDAQ-listed parent credibility and financial resources, RMC bridges the

structural A/R gap inherent in the distributor-to-hospital payment cycle — a capability most independent distributors cannot replicate.

● Scope Expansion and ICC Services:

The 4PL platform aggregates mandates across medical device categories beyond neurointervention,

enhancing scale economics and reducing concentration risk.

In-Country Care (“ICC”) services represent an additional, complementary

revenue stream as the platform matures.

A number of Korean distributors have already approached RMC proactively,

viewing its NASDAQ-listed parent as a credible and well-capitalized consolidator.

Management believes RMC is positioned to execute its

roll-up strategy promptly upon capital allocation by OSR Holdings.

4PL Product Pipeline

The table below sets forth the eleven identified 4PL product categories,

each with estimated Korean market TAM, target MFDS approval year, and projected market share for 2027–2030 (KRW millions).

Product Category

TAM (KRW mil)

159,903 (~$110 mil)

Market share projections reflect management estimates based on identified

pipeline opportunities and distributor consolidation targets.

Actual results may differ materially.

Financial Projections

The table below summarizes RMC’s projected revenue and profitability

across its three segments for fiscal years 2026–2030 (KRW millions).

Current Business

Total Revenue

Forward-looking estimates prepared by management.

Subject to risks

and uncertainties.

See “Forward-Looking Statements” and “Risk Factors” elsewhere in this Annual Report.

Key observations:

(i) 4PL revenue is not projected to commence until

2027, reflecting the time required for mandate acquisition and MFDS approvals following 2026 capital deployment;

(ii) total RMC revenue

is projected to grow from KRW 4.1 billion in 2026 to KRW 44.8 billion in 2030 (~82% CAGR), driven primarily by the 4PL ramp;

net margin is expected to stabilize at approximately 8% from 2028, with the current business providing a stable organic base throughout.

Key Execution Considerations

Investors should be aware of the following principal risks specific

to RMC’s 4PL initiative:

● Capital Deployment:

Execution pace is contingent upon OSR Holdings allocating sufficient capital;

delays could materially impact the

projected revenue ramp.

● Regulatory Timelines:

MFDS oversight of import license and mandate transfers may defer revenue commencement beyond projected periods.

● Foreign Exchange:

RMC will assume USD-denominated MPG obligations;

continued KRW depreciation could increase local currency costs

● Working Capital:

Scaling the platform will require disciplined management of an expanding A/R base given the structural hospital payment

● Pipeline Conversion:

No assurance exists that identified distributor candidates will transfer mandates on commercially acceptable

terms or within projected timeframes.

Management views RMC’s 4PL transformation as one of the most significant

value creation opportunities within the OSR Holdings portfolio.

The Company will provide updates on mandate acquisitions, capital deployed,

and MFDS milestones in its periodic filings and through other public disclosures as material developments warrant.

Intellectual Property

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Members of our management team are not obligated to devote any specific

number of hours to our matters but they intend to devote as much of their time as they, in the exercise of their respective business judgement,

deem necessary to our affairs until we have completed our initial business combination.

The amount of time that any member of our management

team will devote in any time period will vary based on whether a target business has been selected for our initial business combination

and the current stage of the business combination process.

We do not have an employment agreement with any member of our management team.

number of hours to our matters, but they intend to devote as much of their time as they, in the exercise of their respective business

judgment, deem necessary to our affairs until we have completed our initial business combination.

The amount of time that any member of

our management team will devote in any time period will vary based on whether a target business has been selected for our initial business

combination and the current stage of the business combination process.

We do not have an employment agreement with any member of our management

We believe our management team’s operating and transaction experience

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Our executive offices are provided to us by an affiliate of our Sponsor.

Commencing on March 1, 2023, we

agreed to pay an affiliate of our Sponsor a total of $7,500 per month for office space, utilities and secretarial and administrative

Commencing on March 1, 2023, we agreed

to pay an affiliate of our Sponsor a total of $7,500 per month for office space, utilities and secretarial and administrative support.

We consider our current office space adequate for our current operations.

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You should not rely on any such information in making your decision whether to invest in our securities.

We currently have five officers.

We currently have four officers.

These individuals are not obligated

to devote any specific number of hours to our matters but they intend to devote as much of their time as they deem necessary, in the exercise

of their respective business judgement, to our affairs until we have completed our initial business combination.

The amount of time they

will devote in any time period will vary based on whether a target business has been selected for our initial business combination and

the stage of the initial business combination process we are in.

to devote any specific number of hours to our matters, but they intend to devote as much of their time as they deem necessary, in the

exercise of their respective business judgement, to our affairs until we have completed our initial business combination.

The amount of

time they will devote in any time period will vary based on whether a target business has been selected for our initial business combination

and the stage of the initial business combination process we are in.

We do not have an employment agreement with any member of our management

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compliance with the Sarbanes-Oxley Act may increase the time and costs necessary to complete any such business combination.

the date of our prospectus in connection with our IPO, we filed a registration statement on Form 8-A with the SEC to voluntarily register

date of our prospectus in connection with our IPO, we filed a registration statement on Form 8-A with the SEC to voluntarily register

our securities under Section 12 of the Exchange Act.

As a result, we are subject to the rules and regulations promulgated under

the Exchange Act.

We have no current intention of filing a Form 15 to suspend our reporting or other obligations under the Exchange Act

prior or subsequent to the consummation of our initial business combination.

As a result, we are subject to the rules and regulations promulgated under the

Exchange Act.

We have no current intention of filing a Form 15 to suspend our reporting or other obligations under the Exchange Act prior

or subsequent to the consummation of our initial business combination.

We will remain an emerging growth company until the earlier of (1) the

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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