What changed in this filing

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Item 1. Business

2025-03-31 compared with 2024-03-28 · 219 added, 238 removed, 208 unchanged (69% of the section changed)

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Our goals include treating and preventing influenza virus, coronavirus, and norovirus infections by discovering

and developing drug candidates targeting required steps in the viral replication process.

Additionally, one of our goals is to decrease

the duration of HCV therapy.

To discover and design these virus replication inhibitors, we use a proprietary platform comprising computational

chemistry, medicinal chemistry, X-ray crystallography and our extensive know-how.

We determine the structures of cocrystals containing

the inhibitors bound to the viral enzyme or protein to guide our structure-based drug design.

We also use advanced computational methods

to screen and design product candidates using proprietary cocrystal structural information.

In designing the candidates, we seek to anticipate

and avert potential viral mutations leading to resistance.

By designing and selecting drug candidates that interrupt the viral replication

process and also have specific binding characteristics, we seek to develop drugs that are not only effective against both the virus and

possible mutants of the virus, but which also have reduced off-target interactions that may cause undesirable clinical side effects.

and developing direct-acting antiviral drug candidates targeting required steps in the viral replication process.

To discover and design

these direct-acting antiviral drug candidates, we use a proprietary platform comprising computational chemistry, medicinal chemistry,

X-ray crystallography and our extensive know-how.

We determine the structures of cocrystals containing the inhibitors bound to the viral

enzyme or protein to guide our structure-based drug design.

We also use advanced computational methods to screen and design product candidates

using proprietary high-resolution cocrystal structural information.

In designing the candidates, we seek to anticipate and avert potential

viral mutations leading to resistance.

By designing and selecting drug candidates that interrupt the viral replication process and specific

binding characteristics, we seek to develop drugs that are effective against both the virus and possible mutants of the virus and have

reduced off-target interactions that may cause undesirable clinical side effects.

successful application of our approach requires an extensive knowledge of viruses and drug targets.

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proprietary drug discovery technology.

Company’s proprietary technology integrates several powerful and specialized techniques:

Company’s proprietary technology integrates several powerful and specialized computational techniques for drug design:

of viral drug targets amenable to broad-spectrum antiviral drug development and essential for viral genome replication;

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Drug resistance is a major obstacle to developing effective antiviral therapies.

Viruses can reproduce

rapidly and in enormous quantities in infected human cells.

During viral replication, random changes in the viral genome, called mutations,

If such a mutation occurs in a region of the viral genome that is targeted by a given antiviral therapy, that therapy may no

longer be effective against the mutated virus.

These mutated or “resistant” viruses can freely infect and multiply even in

individuals who have received drug treatment.

In some cases, resistant virus strains may even predominate.

For example, in the 2009 swine

influenza pandemic, the predominant strain was resistant to the best available therapies.

During the COVID-19 pandemic outbreak newly

emergent mutated coronaviruses have been identified, pointing out the ineffectiveness of vaccines and therapeutics.

Another example,

the Omicron variant which arose as the dominant strain of COVID-19 in late 2021 until it diminished in the winter of 2022 displayed increased

resistance to available vaccines and treatments, resulting in the limitation or suspension of emergency use authorizations by the FDA

for certain therapeutic products.

In early 2024, a new strain of COVID-19 named JN.1 rapidly grew to the predominant strain of the virus

in circulation, believed to be either more transmissible or better at evading the immune system than other circulating variants.

Company’s focus on viral replication proteins can potentially overcome the obstacle of viral resistance.

We identify and target

critical residues of viral replication proteins that are essential for function, and therefore, sensitive to change.

A mutation in these

critical residues is likely to inactivate or slow down the replication processes and, in turn, render the virus incapable of replicating.

Because such mutations cannot propagate, the virus cannot effectively develop resistance to the enzyme inhibitors we employ.

the effectiveness of our compounds against existing drug resistant variants and select compounds with the highest barrier to resistance.

effective against major strains responsible for a viral disease :

For any given viral disease, there are different strains of viruses

that cause the disease.

reproduce rapidly and in enormous quantities in infected human cells.

During viral replication, random changes in the viral genome,

called mutations, develop.

If such a mutation occurs in a region of the viral genome that is targeted by a given antiviral therapy,

that therapy may no longer be effective against the mutated virus.

These mutated or “resistant” viruses can freely

infect and multiply even in individuals who have received drug treatment.

In some cases, resistant virus strains may even

For example, in the 2009 swine influenza pandemic, the predominant strain was resistant to the best available

During the COVID-19 pandemic outbreak newly emergent mutated coronaviruses were identified, resulting in the

ineffectiveness of some vaccines and therapeutics.

For example, the Omicron variant that arose as the dominant strain of COVID-19 in

late 2021 until COVID-19 diminished in the winter of 2022 displayed increased resistance to available vaccines and treatments,

resulting in the limitation or suspension of emergency use authorizations by the FDA for certain therapeutic products.

2024, a new strain of COVID-19 named JN.1 became the predominant strain of the virus in circulation and was believed to be either

more transmissible or better at evading the immune system than other circulating variants.

As of early 2025, the prevalent variants

of COVID-19 were XEC and LP.8.1, each of which emerged in 2024.

These two variants are variants under monitoring (VUM) by the World

Health Organization as of February 2025 due to their increasing prevalence globally.

Company’s focus on viral drug targets inhibiting replication proteins can potentially overcome the obstacle of viral resistance.

We identify and target critical residues of viral drug targets that are essential for function, and therefore, sensitive to change.

mutation in these critical residues is likely to inactivate or slow down the replication processes and, in turn, render the virus incapable

of replicating.

Because such mutations cannot propagate, the virus cannot effectively develop resistance to the enzyme inhibitors we

We test the effectiveness of our compounds against existing drug-resistant variants and select compounds with the highest barrier

to resistance.

effective against major strains responsible for a viral disease and multiple indications :

For any given viral disease, there are

different strains of viruses that cause the disease.

For example, there are three types of influenza viruses, A, B, and C.

Influenza A and B viruses are significant

human respiratory pathogens that cause seasonal flu and hospitalizations, with influenza A viruses being solely responsible for past

influenza pandemics.

Influenza C is a subtype of the influenza virus that tends to cause only mild illness and is not responsible for

seasonal or pandemic infections.

Our goal is to design and develop drug candidates that will be effective on the broadest possible range

of viruses causing the disease.

A and B viruses are significant human respiratory pathogens that cause seasonal flu and hospitalizations, with influenza A viruses being

solely responsible for past influenza pandemics.

Influenza C is a subtype of the influenza virus that tends to cause only mild illness

and is not responsible for seasonal or pandemic infections.

Our goal is to design and develop drug candidates that will be effective

on the broadest possible range of viruses causing the disease.

antiviral drugs available today are effective only against certain strains of a given virus and less effective or not effective at all

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By targeting these highly conserved regions of the replication enzymes

our antiviral compounds are designed and tested to be effective against major virus strains.

Replication enzymes are generally conserved

not only among subtypes of a given virus but also among many different viruses, creating an opportunity for the development of broad-spectrum

antiviral drugs.

and proteases, our antiviral compounds are designed and tested to be effective against major virus strains.

Replication enzymes and proteases

are generally conserved not only among subtypes of a given virus but also among many different viruses, creating an opportunity for the

development of broad-spectrum antiviral drugs and pan-viral drugs.

onset of action:

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and Development Update

the year ended December 31, 2023 the Company focused its research and development efforts primarily in three areas:

the twelve months ended December 31, 2024 the Company continued to focus its research and development efforts primarily in three areas.

have several candidates under development for the treatment of influenza infection.

CC-42344, a novel PB2 inhibitor, was selected as

a preclinical lead for the treatment of pandemic and seasonal influenza A.

Oral CC-42344 was advanced to a Phase 2a influenza human challenge

clinical study in 2023 as described in more detail below.

This drug candidate binds to a highly conserved PB2 site of influenza polymerase

complex (PB1:

a preclinical lead as an oral or inhaled treatment of pandemic and seasonal influenza A.

This candidate binds to a highly conserved PB2

site of influenza polymerase complex (PB1:

PA) and exhibits a novel mechanism of action.

CC-42344 showed excellent antiviral activity against influenza A strains,

including avian pandemic strains, Tamiflu® and baloxavir resistant strains, and has favorable pharmacokinetic and drug resistance

This drug candidate was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery

platform technology.

March 2022 enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 1 study of orally delivered CC-42344, which

was conducted in Australia.

Later that year we reported favorable safety and tolerability results from the Phase 1 study of CC-42344

for the treatment of both pandemic and seasonal influenza A.

October 2023 we announced receipt of authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA)

to initiate a Phase 2a human challenge trial with oral CC-42344 as a potential treatment for pandemic and seasonal influenza A.

2023 we announced achievement of first-patient-in for this Phase 2a human challenge clinical trial.

This ongoing randomized, double-blind,

placebo-controlled study is evaluating the safety, tolerability, viral and clinical measurements of influenza A infection in subjects

dosed with oral CC-42344 treatment.

Topline clinical results from the Phase 2a trial are expected in 2024.

addition to the oral CC-42344, we developed inhaled CC-42344 for the prophylactic treatment of pandemic and seasonal influenza A infections.

Our preclinical data of the inhaled CC-42344 showed excellent antiviral activity in influenza H1N1-infected human upper airway epithelium

with favorable safety profile.

We completed inhalation formulation development and are evaluating plans to initiate a Phase 1 study in

also continue developing novel broad-spectrum influenza antivirals targeting replication enzymes of influenza A and B strains.

and Norovirus Programs

October 2022 we announced the selection of a novel, broad-spectrum antiviral drug candidate CDI-988 for clinical development as an oral

treatment for SARS-CoV-2, the virus that causes COVID-19.

CDI-988 targets a highly conserved region in the active site of SARS-CoV-2

main (3CL) protease required for viral replication and and was discovered to exhibit pan-coronavirus activity against MERS-CoV, SARS-CoV,

and common coronaviruses.

This drug candidate was specifically designed and developed as a pan-viral protease inhibitor using Cocrystal’s

proprietary structure-based drug discovery platform technology.

preclinical studies demonstrated that pan-coronavirus lead CDI-988 also showed broad-spectrum antiviral activity against the multiple

pandemic norovirus proteases.

High resolution crystal structures confirmed that CDI-988 binds to the highly conserved region of the norovirus

protease active site.

In August 2023 we announced the selection of pan-viral CDI-988 as a potential oral therapy for coronaviruses and

May 2023 we announced approval from the Australian Human Research Ethics Committee (HREC) to conduct a randomized, double-blind, placebo-controlled

Phase 1 study of CDI-988.

The study is designed to access the safety, tolerability and pharmacokinetics of CDI-988.

September 2023 we announced dosing of the first subjects in our Phase 1 clinical study with our oral, first-in-class pan-norovirus and

pan-coronavirus 3CL protease inhibitor CDI-988.

Topline clinical results from the Phase 1 trial are expected in 2024.

A worldwide public health problem, including the potential for pandemic disease .

CC-42344 showed excellent in vitro

antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu® and Xofluza® resistant strains,

and has favorable pharmacokinetic and drug resistance profiles.

addition to the oral candidate of CC-42344, the inhaled CC-42344 is being developed for the potential prophylactic treatment of pandemic

and seasonal influenza infections.

Dry powder inhalation development and toxicology studies have been evaluated.

received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) to conduct a Phase 2a human

challenge study with oral CC-42344 as a potential treatment for pandemic and seasonal influenza A.

This randomized, double-blind, placebo-controlled

study is designed to evaluate the safety, tolerability, viral and clinical measurements of influenza A infection in subjects dosed with

oral CC-42344 treatment.

In May 2024 we announced completion of enrollment of 78 subjects.

In December 2024, the Company announced plans

to extend enrollment for the oral CDI-42344 Phase 2a study due to unexpectedly low influenza infection among study participants.

Specifically,

management determined that an extension of the study is necessary due to low infectivity rate of the challenge influenza strain used

in this study, as the establishment of robust influenza infection in healthy, uninfected study subjects is critical to determine clinical

endpoints for evaluating antiviral molecule, and the low infectivity obtained in this study hindered antiviral data analysis.

is currently in continuing discussions with the clinical research organization to address this study and determine a course forward with

respect thereto, including potentially by preparing a protocol amendment or a resubmission for approval by the United Kingdom Medicines

and Healthcare Products Regulatory Agency (“MHRA”) in order to seek enrollment to study and to ensure necessary infection

rates among enrolled study subjects in the study.

CC-42344 has demonstrated favorable safety and tolerability profile from the Phase

2a study to date, with no SAEs and no drug-related discontinuations by study participants.

June 2024 we reported the potential efficacy of CC-42344 against the new Texas avian flu strain from in vitro studies with the

recently published genome sequence for H5N1.

Using our proprietary structure-based platform technology, the Company reported a high-resolution

cocrystal structure of this avian PB2 protein complexed with CC-42344 and confirmed that CC-42344 binds to its highly conserved PB2 region.

The in vitro data using purified Texas avian H5N1 PB2 protein further showed in vitro affinity of CC-42344 similar to that of

previous data using pandemic avian and seasonal influenza A PB proteins.

also continue developing novel broad-spectrum influenza antivirals targeting replication enzymes of seasonal and pandemic influenza A

and B strains.

and Coronavirus Programs

developed the novel protease inhibitor CDI-988 as an oral pan-viral treatment of noroviruses and coronaviruses, including SARS-CoV-2

and its variants.

CDI-988 was specifically designed and developed using our proprietary structure-based drug discovery platform technology

as a broad-spectrum antiviral inhibitor to a highly conserved region in the active site of noroviruses, coronaviruses and other 3CL viral

We believe CDI-988 represents a first-in-class pan-viral antiviral for the treatment of viral gastroenteritis caused by noroviruses

and coronaviruses, including SARS-CoV-2 and its variants.

CDI-988 is being clinically evaluated for safety, tolerability and pharmacokinetics including a food-effect cohort in healthy volunteers

in a single-center, randomized, double-blind, placebo-controlled Phase 1 study being conducted in Australia.

We expect that the oral

CDI-988 Phase 1 data will support future norovirus and coronavirus Phase 2 and Phase 3 studies.

July 2024 we announced favorable safety and tolerability results from the single-ascending dose (SAD) cohorts of the Phase 1 study with

Study participants in the SAD cohorts received CDI-988 in doses ranging from 100 mg to 600 mg.

All participants completed the

study with no discontinuations.

There were no serious adverse events or severe treatment-emergent adverse events.

No clinically significant

observations were noted in laboratory assessments, physical exams or electrocardiograms.

September 2024 we initiated dosing of the first subjects in the multiple-ascending dose (MAD) portion of the Phase 1 study with CDI-988

and topline Phase 1 study safety and tolerability SAD results and testing of 800 mg for 10 consecutive days were reported in January

2025 indicating favorable safety and tolerability results.

The topline data of the MAD cohorts, including based on an additional cohort

with a higher dose of 1200 mg and a shorter treatment duration of five consecutive days, is expected to be released in the first half

A worldwide public health problem, including the potential for pandemic Avian Flu.

is a severe respiratory illness, caused primarily by influenza A or B virus.

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Strains of influenza virus

that are resistant to the approved treatments oseltamivir phosphate (Tamiflu®) and zanamavir (Relenza®), baloxavir marboxil (Xofluza®)

have appeared, and in some cases are predominated.

resistant to the approved treatments oseltamivir phosphate (Tamiflu®), zanamavir (Relenza®) and baloxavir marboxil (Xofluza®)

have appeared and in some cases are predominant.

For example, the predominant strain of the 2009 swine influenza pandemic was resistant

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Oseltamivir inhibits influenza neuraminidase enzymes, which are not highly conserved between viral strains.

to the WHO, approximately 15% of the H1N1 isolated circulating worldwide were oseltamivir resistant.

to the WHO, approximately 15% of the H1N1 isolates circulating worldwide were oseltamivir resistant.

Also, treatment-emergent resistance

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could significantly diminish baloxavir effectiveness.

Company developed CC-42344, a novel PB2 inhibitor, as a lead candidate for the treatment of influenza A.

We completed a Phase 1 study

with oral CC-42344 and in December 2022 reported on favorable safety and tolerability results from the CC-42344 Phase 1 study.

Upon approval

of United Kingdom MHRA, we initiated a randomized, double-blind, placebo-controlled influenza Phase 2a human challenge study in the first

half of 2023 and announced dosing of the first subjects in this study with oral CC-42344 in December 2023.

Topline clinical results from

the Phase 2a trial are expected in 2024.

COVID-19 continues to be a global pandemic fueled by an emergence of new strains .

a global pandemic with 774,631,044 COVID-19 confirmed cases globally, including 7,031,216 deaths, as of February 27, 2024, according

to the data reported by the WHO.

The COVID-19 pandemic and the measures taken by the federal, state and foreign governments to stop the

spread of the virus have caused a significant disruption to the U.S.

and global economy.

COVID-19 continues to be a global health concern fueled by an emergence of new strains.

is a global health concern responsible for more than 777 million reported cases globally, including more than 7 million deaths, as of

March 2025, according to data reported by the WHO.

Coronaviruses

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from no symptoms to more severe disease that has included pneumonia, severe acute respiratory syndrome, kidney failure, and death.

incubation period for SARS-CoV-2 is believed to be within 14 days after exposure, with most illness occurring within about 5 days after

incubation period for SARS-CoV-2 is believed to be within 14 days after exposure, with most illness occurring within about five days

after exposure.

SARS-CoV-2, like other RNA viruses, is prone to mutate over time, resulting in the emergence of multiple variants.

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of the pandemic.

Also, as demonstrated in Delta and Omicron variants as well as the more recent JN.1 strain, some variations allow the

virus to spread more easily and make it resistant to the treatments and vaccines.

October 22, 2020, FDA approved the antiviral drug Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization.

is a nucleotide prodrug that inhibits viral replication and was previously evaluated in clinical trials for Ebola treatment in 2014.

On May 25, 2023, the FDA approved Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for use to treat COVID-19

for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization

For certain hospitalized adults with COVID-19, the FDA has also approved Olumiant (baricitinib) and Actemra (tocilizumab).

In addition, the FDA issued emergency authorization use on several antibody and antiviral therapeutics, including and Lagevrio (molpiravir).

Also, as demonstrated in the Delta, Omicron and other variants, some variations allow the virus to spread more easily

and make it resistant to the treatments and vaccines.

October 22, 2020, the U.S.

Food and Drug Administration (“FDA”) approved the antiviral drug Veklury® (remdesivir) for

the treatment of COVID-19 requiring hospitalization.

Remdesivir is a nucleotide prodrug that inhibits viral replication and was previously

evaluated in clinical trials for Ebola treatment in 2014.

On May 25, 2023, the FDA approved Paxlovid™ (nirmatrelvir tablets and

ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression

to severe COVID-19, including hospitalization or death.

For certain hospitalized adults with COVID-19, the FDA has also approved Olumiant®

(baricitinib) and Actemra® (tocilizumab).

In addition, the FDA issued emergency use authorization (EUA) for several antibody and

antiviral therapeutics, including and Lagevrio™ (molnupiravir).

continue pursuing the development of novel antiviral compounds for the treatment of coronavirus infections using our established proprietary

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for all coronavirus diseases including COVID-19, Severe Acute Respiratory Syndrome (SARS), and Middle East Respiratory Syndrome (MERS).

- coronaviruses.

A worldwide public health problem responsible for close to 90% of epidemic, non-bacterial outbreaks of gastroenteritis around the world .

is a very common and highly contagious virus that causes symptoms of acute gastroenteritis.

among people of all ages.

infection can be much more severe and prolonged in specific risk groups including infants, children, the elderly, and people with

immunodeficiency.

Symptoms include nausea, vomiting, stomach pain and diarrhea as well as fatigue, fever and dehydration.

occur most commonly in semi-closed communities, having become notorious for their occurrence in hospitals, nursing homes, childcare

A worldwide public health problem responsible for close to 90% of the global epidemic, non-bacterial outbreaks of gastroenteritis with

no effective treatment or vaccine.

is a very common and highly contagious virus that causes symptoms of acute gastroenteritis among people of all ages including nausea,

vomiting, stomach pain and diarrhea as well as fatigue, fever and dehydration.

Norovirus infection can be significantly more severe and

prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency.

In immunosuppressed patients,

chronic norovirus infection can lead to a debilitating illness with extended periods of nausea, vomiting and diarrhea.

Norovirus outbreaks

occur most commonly in semi-closed communities and have become notorious for their occurrence in hospitals, nursing homes, childcare

facilities, cruise ships, schools, disaster relief sites and military settings.

In the United States alone, noroviruses are

responsible for an estimated 21 million cases annually, including 109,000 hospitalizations, 465,000 emergency department visits and

nearly 900 deaths, according to the CDC.

alone, noroviruses are responsible for an

estimated 21 million cases annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths,

according to the CDC.

The NIH estimates the annual burden to the United States at $10.6 billion.

Noroviruses are

responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children in the developing world.

immunosuppressed patients, chronic norovirus infection can lead to a debilitating illness with extended periods of nausea, vomiting

and diarrhea.

There is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is

We have a candidate norovirus therapeutic in clinical testing.

A few companies have been developing vaccines and six

candidate vaccines are in stages of clinical testing by Vaxart Pharmaceutical, Moderna, Hillevax, Takeda Pharmaceuticals, Anhui

Zhifei Longcom Biopharmaceutical (China) and National Vaccine and Serum Institute (China).

Noroviruses are responsible for up to

1.1 million hospitalizations and 218,000 deaths annually in children in the developing world.

is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is limited.

We are developing

a novel norovirus antiviral candidate for the prophylactic and therapeutic treatment of norovirus infection that is currently in a Phase

1 clinical study.

A few companies have been developing vaccines and are in stages of clinical testing, including Vaxart Pharmaceutical,

Moderna, Hillevax, Takeda Pharmaceuticals, Anhui Zhifei Longcom Biopharmaceutical (China) and National Vaccine and Serum Institute (China).

targeting viral replication enzymes and a viral protease, we believe it is possible to develop an effective treatment for all genogroups

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Also, because of the significant unmet medical need and the possibility of chronic norovirus infection in immunocompromised

individuals, new antiviral therapeutic approaches may warrant an accelerated path to market.

The Company is developing inhibitors of

the RNA-dependent RNA polymerase and protease of norovirus.

Similar to the HCV polymerases, these enzymes are essential to viral replication

and are highly conserved between all noroviral genogroups.

Therefore, an inhibitor of these enzymes might be an effective treatment or

short-term prophylactic agent, when administered during a cruise or nursing home stay, for example.

We have developed X-ray quality norovirus

polymerase and protease crystals and have identified promising inhibitors.

We are implementing the platform and approaches that have

proven successful in our other antiviral programs.

September 2023 we announced dosing of the first subjects in our Phase 1 clinical study with our oral, first-in-class pan-norovirus and

pan-coronavirus 3CL protease inhibitor CDI-988.

Topline clinical results from the Phase 1 trial are expected in 2024.

individuals, new antiviral therapeutic and prophylactic approaches may warrant an accelerated path to market.

We are developing inhibitors

of the RNA-dependent RNA polymerase and protease of norovirus.

These enzymes are essential to viral replication and are highly conserved

between all noroviral genogroups.

Therefore, an inhibitor of these enzymes might be an effective treatment or short-term prophylactic

agent, when administered during a cruise or nursing home stay, for example.

We have developed X-ray quality norovirus polymerase and

protease crystals and have identified promising inhibitors.

We are implementing our proprietary drug discovery platform technology and

approaches that have proven successful in our other antiviral programs.

A large competitive market with opportunity for shorter treatment regimens.

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have been approved for the treatment of HCV infection.

These include Harvoni (sofosbuvir/ledipasvir) 12 weeks of treatment, Viekira Pak

(ombitasvir/paritaprevir/ritonavir, dasabuvir) twelve weeks of treatment, Epclusa (sofosbuvir/velpatasvir) twelve weeks of treatment,

Zepatier (elbasvir/grazoprevir) twelve weeks of treatment and Mavyret (glecaprevir/pibrentasvir) eight weeks of treatment.

the next improvements in HCV treatment will be ultra-short combination oral treatments of four to six weeks, which is the goal of our

These include Harvoni® (sofosbuvir/ledipasvir) 12 weeks of treatment, Viekira

Pak™ (ombitasvir/paritaprevir/ritonavir, dasabuvir) 12 weeks of treatment, Epclusa® (sofosbuvir/velpatasvir) 12 weeks of treatment,

Zepatier™ (elbasvir/grazoprevir) 12 weeks of treatment and Mavyret® (glecaprevir/pibrentasvir) eight weeks of treatment.

believe the next improvements in HCV treatment will be ultra-short combination oral treatments of four to six weeks, which is the goal

of our program.

anticipate a significant global HCV market opportunity that will persist through at least 2036, given the large prevalence of HCV infection

The 2024 World Health Organization Global Hepatitis Report estimates that 50 million people worldwide have chronic HCV infections

In July 2023, WHO published that globally, an estimated 58 million people have chronic HCV infection, with about 1.5 million new infections

occurring per year, and an estimated 3.2 million adolescents and children with chronic HCV infection.

are targeting the viral NS5B polymerase with an NNI, which could be developed as part of an all-oral, pan-genotypic combination regimen.

Our focus is on developing what is now called ultrashort treatment regimens from four to six weeks in length.

Such a combination treatment

CC-31244 with different classes of approved DAAs has the potential to change the paradigm of treatment for HCV with a shorter duration

of treatment.

Combination strategies with approved drugs could allow us to expand CC-31244 into the HCV antiviral therapeutic area globally

and could lead to a high and fast cure rate, to improved compliance, and to reduced treatment duration.

To our knowledge no competing

company has yet developed a short HCV treatment of less than 8 weeks with a high (>95%) sustained virologic response (SVR) at week

with about 1 million new infections occurring per year and an estimated 3.2 million adolescents and children with chronic HCV infection.

are targeting the viral NS5B polymerase with a non-nucleoside inhibitor (“NNI”), which could be developed as part of an all-oral,

pan-genotypic combination regimen.

Our focus is on developing what is now called ultrashort treatment regimens from four to six weeks

Combining CC-31244 with different classes of approved direct-acting antivirals (“DAAs”) has the potential to change

the paradigm of treatment for HCV by shortening the duration of treatment.

Combination strategies with approved drugs could allow us

to expand CC-31244 into the HCV antiviral therapeutic area globally and could lead to a high and fast cure rate, to improved compliance,

and to reduced treatment duration.

To our knowledge no competing company has yet developed a short HCV treatment of less than 8 weeks

with a high (>95%) sustained virologic response (SVR) at week 12.

an HCV NNI, is a potential best in class pan-genotypic inhibitor of NS5B polymerase for the treatment of HCV.

The Company completed a

Phase 1a/b study in Canada in September 2016, with favorable safety results in a randomized, double-blinded, Phase 1a/b study in healthy

volunteers and HCV-infected subjects.

The Company completed a Phase 2a study in HCV genotype 1 subjects in the United States.

presented the interim results from the Phase1a/b study at the APASL in February 2017.

HCV-infected subjects treated with CC-31244 had

a rapid and marked decline in HCV RNA levels, and slow viral rebound after treatment.

Results of this study suggest that CC-31244 could

be an important component in a shortened duration all-oral HCV combination therapy.

The Company has completed the Phase 2a final study

report as filed with the FDA.

See “Item 1 – Business – Research and Development Update – Hepatitis C” for

more information.

Company has been seeking a partner for further clinical development of CC-31244 since completing Phase 2a trials.

We completed a randomized,

double-blinded Phase 1a/b study in healthy volunteers and HCV-infected subjects in Canada in September 2016, with favorable safety results.

We completed a Phase 2a study in HCV genotype 1 subjects in the U.S.

HCV-infected subjects treated with CC-31244 had a rapid

and marked decline in HCV RNA levels, and slow viral rebound after treatment.

Results of this study suggest that CC-31244 could be an

important component in a shortened duration all-oral HCV combination therapy.

In 2017, we completed the Phase 2a final study report as

filed with the FDA.

have been seeking a partner for further clinical development of CC-31244 since completing a Phase 2a study.

success depends, in part, upon our ability to protect our core technology.

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Collaborations

Collaboration

January 2, 2019, we entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration Agreement”)

with Merck Sharp & Dohme LLC (“Merck”) to discover and develop certain proprietary influenza A/B antiviral agents.

the terms of the Collaboration Agreement, Merck is funding research and development for the program at Cocrystal and Merck, including

clinical development at Merck, protecting intellectual property and Merck is responsible for worldwide commercialization of any products

derived from the collaboration.

December 15, 2023, we received written notice from Merck of Merck’s election to terminate the Collaboration Agreement, dated January

2, 2019, by and between the Company and Merck, with respect to the collaboration with Merck on the development of influenza A/B antiviral

The termination of the Agreement is effective on March 14, 2024.

The termination of the Agreement took effect on March 14, 2024.

The termination resulted from the inability to develop the

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State University Research Foundation

entered into a License Agreement with KSURF on February 18, 2020 to further develop certain proprietary broad-spectrum antiviral compounds

for the treatment of norovirus and coronavirus infections.

to the terms of the License Agreement, KSURF granted the Company an exclusive royalty bearing license to practice under certain patent

rights, under patent applications covering antivirals against coronaviruses, caliciviruses, and picornaviruses, and related know-how,

including to make and sell therapeutic, diagnostic and prophylactic products.

Company agreed to pay KSURF a one-time non-refundable license initiation fee of $80,000 under the License Agreement, and annual license

maintenance fees.

The Company also agreed to make certain future milestone payments of up to approximately $3.1 million, dependent upon

the progress of clinical trials, regulatory approvals, and initiation of commercial sales in the United States and certain countries

outside the United States.

April 19, 2020, the Company entered into a second License Agreement with KSURF in addition to the License Agreement entered into in February

to the terms of the second License Agreement, KSURF granted the Company an exclusive royalty bearing license to practice under certain

patent rights under patent applications covering antivirals against coronaviruses, caliciviruses, and picornaviruses, and related know-how,

including to make and sell therapeutic, diagnostic and prophylactic products.

Company agreed to pay KSURF a one-time non-refundable license initiation fee and annual license maintenance fees.

The Company also agreed

to make certain future milestone payments of up to approximately $4.2 million, dependent upon the progress of clinical trials, regulatory

approvals, and initiation of commercial sales in the United States and certain countries outside the United States.

February 28, 2024, the Company provided notice to KSURF of the Company’s election to terminate the License Agreements.

The terminations,

which were made due to the Company’s determination that further development efforts under the License Agreements would be futile,

are effective on March 29, 2024.

The Company continues to clinically progress its fully owned compound CDI-988 for coronaviruses and

entered into two License Agreement with KSURF (the “Foundation”) on February 18, 2020 to further develop certain proprietary

broad-spectrum antiviral compounds for the treatment of norovirus and coronavirus infections.

February 28, 2024, the Company provided notice to the Foundation of the Company’s election to terminate the 2020 License Agreements.

The terminations, which were made due to the Company’s determination that further development efforts under the License Agreements

would be futile, took effect on March 29, 2024.

Business-Competition

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will depend, to a great extent, on the speed in which we and our collaborators can develop safe and effective product candidates, complete

clinical testing and regulatory approval processes, and coordinate with third parties to produce and distribute the resulting products

in sufficient commercial quantities to create and maintain a market for such products at favorable costs and prices.

If we do complete

development of and obtain regulatory approval to market any product candidate, we anticipate that the competition we would face with

respect to such product would be based on a combination of a number of factors including efficacy, safety, reliability, availability,

price, patent position, and other factors.

effective clinical testing and advance through regulatory approval processes, and coordinate with third parties to produce and distribute

the resulting products in sufficient commercial quantities to create and maintain a market for such products at favorable costs and prices.

If we do complete development of and obtain regulatory approval to market any product candidate, we anticipate that the competition we

would face with respect to such product would be based on a combination of a number of factors including efficacy, safety, reliability,

availability, price, patent position, and other factors.

authorities extensively regulate the research, development, testing, manufacturing and commercialization of drug products.

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and production, we also must comply with applicable laws and regulations of any foreign jurisdictions in which we operate.

as a result of our Phase 1 trial in Australia for CC-42344, our lead Influenza A product candidate, we are subject to the Australian

government’s laws and regulations pertaining to the research and development, including clinical testing on human subjects, of

therapeutic product candidates.

Further, our Phase 2a study for in the United Kingdom in 2023 for CC-42344 subjects us to similar laws

and regulations in the United Kingdom.

as a result of our Phase 1 trial in Australia for CDI-988, our lead norovirus and coronavirus product candidate, we are subject to the

Australian government’s laws and regulations pertaining to the research and development, including clinical testing on human subjects,

of therapeutic product candidates.

Further, our Phase 2a study for in the United Kingdom for CC-42344 subjects us to similar laws and

regulations in the United Kingdom.

Our presence in foreign countries has also subjected us to more general laws applicable to operations

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similar anti-corruption laws and/or regulations.

Further, because of our reliance on one or more CROs and CMOs with respect to our research

and development activities both in the U.S.

and in foreign jurisdictions, we may have limited control over compliance with such requirements

in certain instances.

of March 28, 2024, we employed 12 full-time employees.

Of these full-time employees, nine are engaged in research and development activities.

In addition, we have contracts with CROs, CMOs and consultants to provide chemistry, toxicology, preclinical, clinical, and regulatory

work on our programs, including in both preclinical and clinical studies for our product candidates.

Further, because of our reliance on one or more CROs and clinical manufacturing organizations

(“CMOs”) with respect to our research and development activities both in the U.S.

and in foreign jurisdictions, we may have

limited control over compliance with such requirements in certain instances.

of December 31, 2024, we employed 11 full-time employees.

Of these full-time employees, eight are engaged in clinical advancement and

research and development activities.

In addition, we have contracts with CROs, CMOs and consultants to provide chemistry, toxicology,

preclinical, clinical, and regulatory work on our programs, including in both preclinical and clinical studies for our product candidates.

corporate website is www.cocrystalpharma.com.

4 unchanged sentences

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