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Item 1. Business

2024-04-04 compared with 2023-03-29 · 504 added, 570 removed, 941 unchanged (53% of the section changed)

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developing products using both natural and engineered phage technologies designed to target and kill specific harmful bacteria associated

with chronic diseases, such as cystic fibrosis, or CF.

Bacteriophage or phage are bacterial, species-specific, strain-limited viruses

that infect, amplify and kill the target bacteria and are considered inert to mammalian cells.

By utilizing proprietary combinations of

naturally occurring phage and by creating novel phage using synthetic biology, we develop phage-based therapies intended to address both

large-market and orphan diseases.

In our therapeutic programs, we focus on using phage

therapy to target specific strains of pathogenic bacteria that are associated with diseases.

Our phage-based product candidates are developed

utilizing our proprietary research and development platform named BOLT.

with chronic diseases, such as cystic fibrosis, or CF and diabetic foot osteomyelitis, or DFO.

Bacteriophage or phage are bacterial, species-specific,

strain-limited viruses that infect, amplify and kill the target bacteria and are considered inert to mammalian cells.

By utilizing proprietary

combinations of naturally occurring phage and by creating novel phage using synthetic biology, we develop phage-based therapies intended

to address both large-market and orphan diseases.

Based on the urgency of treating the infection (whether acute or chronic),

the susceptibility of the target bacteria to phage (e.g.

the ability to identify a phage cocktail that would target a broad range of bacterial

strains) and other considerations, we offer two phage-based product types:

(1) Fixed cocktail therapy – in this approach a single product containing a fixed number of selected phages is developed to cover

a wide range of bacterial strains, thus allowing treatment of broad patient populations with the same product.

Fixed cocktails are developed

using our proprietary BOLT platform, in which high throughput screening, directed evolution, and bioinformatic approaches are leveraged

to produce an optimal phage cocktail.

(2) Personalized therapy – in this approach a large library of phages is developed, of which single optimal phages are personally

matched to treat specific patients.

Matching optimal phages with patients is carried out using a proprietary phage susceptibility testing,

or PST, where multiple considerations are analyzed simultaneously – allowing for an efficient screen of the phage library while

maintaining short turnaround times.

In our therapeutic programs, we focus on using

phage therapy to target specific strains of pathogenic bacteria that are associated with diseases.

Our phage-based product candidates

are developed utilizing our BOLT proprietary research and development platform.

The BOLT platform is unique, employing cutting edge methodologies

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such as broad target host range, ability to prevent resistance, biofilm penetration, stability and ease of manufacturing.

Our goal is to develop multiple products based on the

ability of phage to precisely target harmful bacteria and on our ability to screen, identify and combine different phage, both naturally

occurring and created using synthetic engineering, to develop these treatments.

Our goal is to develop multiple products based

on the ability of phage to precisely target harmful bacteria and on our ability to screen, identify and combine different phage, both

naturally occurring and created using synthetic engineering, to develop these treatments.

Our Product Pipeline

below identifies our product candidates’ pipeline, their current status and expected timing for the upcoming milestones.

not have any products approved or available for sale, our product candidates are still in the preclinical and clinical development stages,

and we have not generated any revenue from product sales.

below identifies our product candidates’ pipeline, their current status and expected timing for upcoming milestones.

We do not have

any products approved or available for sale, our product candidates are still in the preclinical and clinical development stages, and

we have not generated any revenue from product sales.

Ongoing Programs

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under development for chronic pulmonary infections caused by Pseudomonas aeruginosa, or P.

aeruginosa, a main contributor

to morbidity and mortality in patients with CF.

Enhanced resistance to antibiotics develops, particularly in CF patients, due to extensive

drug use consisting of prolonged and repeated broad-spectrum antibiotic courses often beginning in childhood, and leading to the appearance

of multidrug-resistant strains.

aeruginosa, a main contributor to morbidity

and mortality in patients with CF.

Enhanced resistance to antibiotics develops, particularly in CF patients, due to extensive drug use

consisting of prolonged and repeated broad-spectrum antibiotic courses often beginning in childhood, and leading to the appearance of

multidrug-resistant strains.

In preclinical in vitro studies, BX004 was shown to be active against antibiotic resistant strains

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respiratory infections caused by P.

is comprised of two parts.

The study design is based on recommendations from the

Cystic Fibrosis Therapeutic Development Network.

was comprised of two parts.

The study design was based on recommendations from

the Cystic Fibrosis Therapeutic Development Network.

In February 2023, we announced positive results

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Part 1 evaluated the safety, tolerability, pharmacokinetics, or PK, and microbiologic

activity of BX004 over a 7-day treatment period in nine CF patients (7 on BX004, 2 on placebo) with chronic P.

aeruginosa pulmonary infection

in a single ascending dose and multiple dose design.

activity of BX004 over a 7-day ascending treatment period in nine CF patients (7 on BX004, 2 on placebo) with chronic P.

pulmonary infection in a single ascending dose and multiple dose design.

Results from Part 1 of the Phase 1b/2a trial included

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No safety events related to treatment with BX004 occurred;

aeruginosa colony forming units (CFU) at Day

15 (compared to baseline):

aeruginosa colony forming units, or CFU, at

Day 15 (compared to baseline):

-1.42 log (BX004) vs.

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no phage were detected in patients receiving placebo;

there was no emerging resistance to BX004 during or after

treatment with BX004;

and there was no detectable effect on % predicted FEV1.

Part 2 of the Phase 1b/2a trial will evaluate the safety

and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio.

Results from Part 2 are expected in

the third quarter of 2023.

In January 2022, we announced that we received an award

of up to $5 million from the Cystic Fibrosis Foundation, or CF Foundation, in two tranches.

The first tranche of $3 million, was received

on December 21, 2021, as an equity investment.

Upon completion of patient dosing in Part 1 of our Phase 1b/2a study of BX004 we had the

right to receive the second tranche of $2 million, also as an equity investment.

Following the results from Part 1 of the ongoing

Phase 1b/2a trial, the CF Foundation agreed to make its second tranche investment of $2 million through its participation in the Company’s

$7.5 million private placement.

The funding provided by the CF Foundation will be used to support the development of BX004.

there was no evidence of treatment-related resistance to

BX004 during or after treatment , compared to placebo;

and as expected due to the short duration of treatment, there was no detectable

effect on % predicted forced expiratory volume in 1 second, or FEV1.

In November 2023, we announced positive topline

results from Part 2 of the Phase 1b/2a trial evaluating BX004.

The objectives of Part 2 of the Phase 1b/2a trial were to evaluate the

safety and tolerability of BX004 in a larger number of CF patients dosed for a longer treatment duration than Part 1 of the study, with

the anticipation that the longer treatment might result in greater effects than in the Part 1.

In Part 2, 34 CF patients were randomized

in a 2:1 ratio with 23 CF patients receiving BX004 and 11 patients receiving placebo via nebulization twice daily for 10 days.

Key results from Part 2 of the Phase 1b/2a trial included the following

● Study drug was safe and well-tolerated, with no related SAEs

(serious adverse events) or related APEs (acute pulmonary exacerbations) to study drug.

● In the BX004 arm, 3 out of 21 (14.3%) patients with quantitative

CFU at baseline converted to sputum culture negative for P.

aeruginosa after 10 days of treatment (including 2 patients

after 4 days) compared to 0 out of 10 (0%) in the placebo arm.

placebo showed a positive clinical effect in a predefined

subgroup of patients with reduced baseline lung function (FEV1<70%).

Difference between groups at Day 17:

relative FEV1 improvement

of 5.67% (change from baseline +1.46 vs.

-4.21) and +8.87 points in Cystic Fibrosis Questionnaire-Revised (CFQR) respiratory

symptom scale (change from baseline +2.52 vs.

● In full population, BX004 vs.

aeruginosa levels

were more variable in sputum, potentially driven by aligning initiation of study drug administration with the initiation of standard

of care antibiotic treatment regimen.

In a prespecified subgroup of patients on standard of care inhaled antibiotics on continuous regimen,

placebo reduced sputum P.

aeruginosa levels at Day 10:

difference in change from baseline between groups of -2.8

log10 CFU/g sputum (change from baseline -2.91 vs -0.11), exceeding Part 1 results.

● Alternating/cycling background antibiotic regimen likely associated

with fluctuations in P.

aeruginosa levels potentially confounding the ability to observe a P.

aeruginosa reduction

in this subgroup.

● During the study period, based on current available data,

no evidence of treatment-related phage resistance was observed in patients treated with BX004 compared to placebo.

In August 2023, the FDA granted BX004 Fast Track

designation for the treatment of chronic respiratory infections caused by P.

aeruginosa bacterial strains in patients with CF.

In addition, in December 2023, BX004 received orphan drug designation from the FDA.

BiomX expects to initiate a randomized, double blind, placebo-controlled, multi-center

Phase 2b study in CF patients with chronic P.

aeruginosa pulmonary infections in the fourth quarter of 2024.

The study is designed

to enroll approximately 60 patients randomized at a 2:1 ratio to BX004 or placebo.

Treatment is expected to be administered via inhalation

twice daily for a duration of 8 weeks.

The study is designed to monitor the safety and tolerability of BX004 and is designed to demonstrate

improvement in microbiological reduction of P.

aeruginosa burden and evaluation of effects on clinical parameters such as

lung function measured by FEV1 and patient reported outcomes.

Study results are expected in the third quarter 2025.

BX211 – Treatment of Diabetic Foot Osteomyelitis (DFO)

BX211 is a personalized phage therapy for the treatment

of DFO associated with Staphylococcus aureus, or S.

The personalized phage treatment tailors a specific phage selected

from a proprietary phage-bank according to the specific strain of S.

aureus biopsied and isolated from each patient.

DFO is a bacterial

infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes.

We believe that scientific literature demonstrating the potential benefit in treating osteomyelitis using phage in animal models as well

as numerous successful compassionate cases using phage therapy to treat DFO patient support our approach of using phage therapy to treat

The ongoing randomized, double-blind, placebo-controlled,

multi-center phase 2 study investigating the safety, tolerability, and efficacy of BX211 for subjects with DFO associated with S.

is expected to enroll approximately 45 subjects randomized at a 2:1 ratio to BX211 or placebo.

BX211 or placebo is designed to be administered

weekly, by topical and intravenous, or IV route at week 1 and by the topical route only at each of weeks 2-12.

Over the 12-week treatment

period, all subjects are expected to continue to be treated in accordance with standard of care which will include antibiotic treatment

as appropriate.

A first readout of study topline results is expected at week 13 evaluating healing of the wound associated with osteomyelitis,

followed by a second readout at week 52 evaluating amputation rates and resolution of osteomyelitis based on X-ray, clinical assessments,

and established biomarkers (Erythrocyte Sedimentation Rate, or ESR, and C-Reactive Protein, or CRP).

These readouts are expected in the

first quarter of 2025 and the first quarter of 2026, respectively.

National Institutes of Health, or NIH study in Cystic Fibrosis

We are supporting a study conducted by the NIH and The Antibacterial

Resistance Leadership Group targeting P.

Aeruginosa infections in CF patients under FDA emergency Investigational New Drug, or

eIND allowance.

The Phase 1b/2, multi-centered, randomized, double-blind, placebo-controlled trial is assessing the safety and microbiological

activity of a single IV dose of bacteriophage therapy in cystic fibrosis subjects colonized with P.

Programs on hold

BX005 – Treatment of Atopic Dermatitis

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aureus strains (120 strains isolated from skin of subjects from the

We are currently supporting a range of pre-clinical

activities to move this program forward and working on evaluating timelines for a clinical trial.

On April 8, 2022, the FDA approved the Company’s

IND application for BX005.

In October 2021, we entered into a stock purchase

agreement with a subsidiary of Maruho Co.

Ltd., or Maruho, a leading dermatology-focused pharmaceutical company in Japan, pursuant to

which we issued to Maruho 375,000 shares of our common stock, par value $0.0001 per share, or Common Stock, at a price of $8.00 per share

for gross proceeds of $3 million.

We also granted Maruho a right of first offer to license BX005, in Japan.

The right of first offer will

commence following the availability of results from the Phase 1/2 study.

Programs on hold

BX003 – Treatment of IBD and PSC

In November 2020, we combined our inflammatory bowel

disease, or IBD and primary sclerosing cholangitis, or PSC programs to create a single product candidate called BX003, which targets K.

pneumoniae to treat both diseases.

Previously, we had separate candidates named BX002 and BX003.

In February 2021, a Phase 1a pharmacokinetic

study of BX002 demonstrated that it was safe and well-tolerated with no serious adverse events, and with high concentrations of viable

phage delivered to the gastrointestinal tract.

On November 15, 2021, we announced that we have paused

development efforts for BX003 due to prioritizing resources towards our CF and AD programs, and we cannot provide guidance on resuming

its development.

We are developing synthetically engineered phage to

target bacteria found in colorectal tumors.

We observed in vitro and in vivo that phage can be used to target Fusobacterium nucleatum,

which is commonly found in colorectal tumors.

Our goal is to use phage to deliver payload genes, such as those encoding immunostimulatory

proteins, to tumors and eradicate the bacteria.

We have successfully engineered an IL-15 gene into F.

nucleatum phage.

On November 15, 2021, we announced that we have paused

development efforts for this program due to prioritizing resources towards our CF and AD programs, and we cannot provide guidance on resuming

On April 8, 2022, the FDA approved the Company’s IND application for BX005.

As of the date of this Annual Report, we have paused

development efforts for BX005 due to prioritizing resources towards our CF and DFO programs, and we cannot provide guidance on resuming

its development.

Discontinued programs

BX001 – Treatment of Acne

BX001 is a topical gel developed to modify skin appearance

in a range of skin types, including acne-prone skin, using naturally occurring phage that target Cutibacterium acnes, or C.

A 4-week Phase 1 clinical study demonstrated that BX001 was safe, well-tolerated, and significantly reduced C.

acnes levels for

the high dose compared to the placebo.

A 12-week Phase 2 clinical study on 140 women with mild-to-moderate acne vulgaris found that BX001

was well-tolerated, and a statistically significant improvement in the appearance of acne-prone skin was observed.

However, there was

no meaningful difference demonstrated compared to the placebo arm of the study.

As a result, we decided to discontinue the program.

Our goal is to develop multiple products based on the

ability of phage to precisely target harmful bacteria and on our ability to screen, identify and optimally combine different phage, both

naturally occurring and generated using synthetic engineering, to develop these treatments.

Prosthetic Joint Infections, or PJI

Our personalized phage therapy for treating PJI

targets multiple bacterial organisms such as Staphylococcus aureus, Staphylococcus epidermidis and Enterococcus faecium.

This treatment

was granted Orphan-drug designation by the FDA in July 2020.

As of the date of this Annual Report, we have paused development efforts

of this program due to prioritizing resources towards our CF and DFO programs, and we cannot provide guidance on resuming its development.

Our goal is to develop multiple products based

on the ability of phage to precisely target harmful bacteria and on our ability to screen, identify and optimally combine different phage,

both naturally occurring and generated using synthetic engineering, to develop these treatments.

We intend to continue to:

● Investigate clinical safety

and efficacy of our lead phage-based product candidates in CF;

and efficacy of our lead phage-based product candidates to treat CF and DFO;

Identify new pathogenic bacteria to be targeted by phage therapy for our existing indications and possible new indications;

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to treat conditions and diseases by precisely targeting pathogenic bacteria without disrupting elements of the healthy microbiota.

Our phage-based product candidates are developed

utilizing our proprietary research and development platform named BOLT.

The BOLT platform is unique, employing cutting edge methodologies

and capabilities across disciplines including computational biology, microbiology, synthetic engineering of phage and their production

bacterial hosts, bioanalytical assay development, manufacturing and formulation, to allow agile and efficient development of natural or

engineered phage combinations, or cocktails.

BOLT is designed to allow the rapid development of

optimized phage cocktails.

Our phage-based product candidates, either fixed

phage cocktails or personalized phage treatments, are developed utilizing our proprietary research and development platforms, named BOLT

The BOLT, platform is unique, employing cutting edge methodologies and capabilities across disciplines including computational

biology, microbiology, synthetic engineering of phage and their production bacterial hosts, bioanalytical assay development, manufacturing

and formulation, to allow agile and efficient development of natural or engineered phage combinations, or cocktails.

The PST platform utilizes proprietary assays to

allow us to screen extensive phage libraries in search of optimal phage for treatment of the specific target bacteria isolated from a

given patient.

BOLT is designed to allow the rapid development

of optimized phage cocktails.

These cocktails may be comprised of naturally-occurring or synthetically engineered phage.

The cocktail contains

phage with complementary features and is optimized for multiple characteristics such as broad target host range, ability to prevent resistance,

biofilm penetration, stability and ease of manufacturing.

Pre-clinical development of the optimized phage cocktail is anticipated to require

combine multiple technologies that originate from the laboratories of our scientific founders and that were developed internally.

that were developed by its scientific founders are described in leading scientific journals.

One of our scientific founders, Professor

Rotem Sorek, a Professor in the Department of Molecular Genetics at the Weizmann Institute of Science, or WIS, is a world leader in phage

genomics and bacterial defense mechanisms.

Another scientific founder, Professor Eran Elinav, a Professor in the Department of Immunology

at the WIS, is an expert in investigating the link between the microbiome and human health and disease.

Our third scientific founder,

Professor Timothy K.

Lu, is a world leader in synthetic biology approaches to engineering gene circuits and phage, leading the Synthetic

Biology Group in the Department of Electrical Engineering and Computer Science and the Department of Biological Engineering at the Massachusetts

Institute of Technology.

contains phage with complementary features and is optimized for multiple characteristics such as broad target host range, ability to prevent

resistance, biofilm penetration, stability and ease of manufacturing.

Pre-clinical development of the optimized phage cocktail is anticipated

to require 1-2 years.

We combine multiple technologies that originate

from the laboratories of our scientific founders and that were developed internally.

Technologies that were developed by our scientific

founders are described in leading scientific journals.

One of our scientific founders, Professor Rotem Sorek, a Professor in the Department

of Molecular Genetics at the Weizmann Institute of Science, or WIS, is a world leader in phage genomics and bacterial defense mechanisms.

Another scientific founder, Professor Eran Elinav, a Professor in the Department of Immunology at the WIS, is an expert in investigating

the link between the microbiome and human health and disease.

Our third scientific founder, Professor Timothy K.

Lu, is a world leader

in synthetic biology approaches to engineering gene circuits and phage, leading the Synthetic Biology Group in the Department of Electrical

Engineering and Computer Science and the Department of Biological Engineering at the Massachusetts Institute of Technology.

addition, through the acquisition of the privately held Israel-based company, RondinX Ltd.

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is critical in enabling us to focus on treating complex human diseases and conditions by precise manipulation of the microbiome.

Additionally, we developed proprietary assays and

screening technology for robust and high throughput testing PST.

The PST platform combines state of the art automation with advanced microbiology

The output is a reproducible conclusive decision for optimal phage matching, based on multiple factors, including success of phage

infection, suppression of resistant mutants, and antibiofilm activity.

Manufacturing

We have developed a manufacturing process that

utilizes state of the art industrial methods for the manufacturing of our product candidates.

This process is designed to comply with

We have developed manufacturing processes that

utilize state of the art industrial methods for the manufacturing of our product candidates.

These processes are designed to comply with

current Good Manufacturing Practice, or cGMP, with the appropriate scale to meet our clinical study needs, and to fulfill the requirements

of regulators for human studies.

We currently operate a manufacturing model that combines an in-house process development and manufacturing

suite with the flexibility to outsource to third-party manufacturing organizations when needed.

As such, for BX004 we have engaged an

additional third-party provider to supplement our in-house process development activities.

We have selected this organization based on

its experience, capability, capacity and regulatory status.

Projects are managed by a specialist team of our internal staff, who assure

compliance with the technical aspects and regulatory requirements of the manufacturing process.

We maintain service agreements with multiple manufacturers.

These service agreements generally are short-term in nature and can be extended or renewed.

The production amounts identified in our current

service agreements are sufficient to support our current clinical study needs.

In March 2021, we moved into a new 6,500 square

foot manufacturing facility in our headquarters, in Ness Ziona, Israel.

Our facility is designed with the capacity to produce clinical

quantities of our product candidates required for future early-stage clinical development.

Our facility consists of two suites for drug

substance phage production/development as well as formulation and final drug product production rooms to support topical, oral, inhaled

and injectable phage-based products in a liquid, cream, semi-solid or dry form.

While we do not have a current need for a commercial

scale manufacturing capacity, at the appropriate time we intend to evaluate building large scale cGMP internal manufacturing capabilities,

which may include expansion of our operations.

In February 2021, we consolidated our U.S.

Manufacturing Practice, or GMP, manufacturing, testing and development into a 6,100 square feet space in our Gaithersburg facility and

in March 2021, we moved into a new 6,500 square feet manufacturing facility in our headquarters, in Ness Ziona, Israel.

Both facilities

are designed to produce clinical quantities of our product candidates required for early-stage clinical development with compliance suitable

for this stage of development and to support eIND.

The Ness Ziona facility consists of two suites

for drug substance phage production/development as well as formulation and final drug product production rooms to support topical, oral,

inhaled and injectable phage-based products in a liquid, cream, semi-solid or dry form.

The Gaithersburg facility consists of three manufacturing

suites, one for upstream seed banking, one for drug substance phage production, and one for formulation and fill of the final drug product.

This facility is also equipped with in-house quality control testing laboratories to support the release of injectable phage-based products

in a liquid form.

Additional laboratory space is allocated for process development and there are laboratory and office spaces available

that can be repurposed for future GMP expansion.

We currently operate a manufacturing model that

combines in-house process development, manufacturing and testing with the flexibility to outsource to third-party development, manufacturing,

testing, and logistics organizations, when needed.

We maintain service agreements with multiple manufacturers, testing laboratories and

a third-party logistics warehouse for product candidate distribution.

These service agreements are generally short-term in nature and

can be extended or renewed.

As such, for BX004, we have engaged a third-party to supplement our in-house process development activities.

We selected this organization based on its experience, capability, capacity and regulatory status.

Manufacturing and development projects

are managed by a team of internal staff who assure compliance with the technical aspects and regulatory requirements of the manufacturing

Additional phage bank product candidates collectively

known as BX211 are manufactured at our in-house GMP facility in Gaithersburg.

Such product candidates are produced and released by internal

staff in compliance with cGMPs.

We perform release testing in house for most release assays and also outsource testing to qualified laboratories.

In addition, we utilize a third-party logistics warehouse for product storage and distribution to clinical sites.

We are considering consolidation of the two GMP

sites into one based on future needs.

While we do not have a current need for a commercial scale manufacturing capacity, at the appropriate

time we intend to evaluate building large scale cGMP internal manufacturing capabilities, which may include expansion of our operations.

Intellectual Property

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We co-own one US patent family with Keio University in Tokyo, Japan, or Keio, one international patent family (United

States, Australia, Brazil, Canada, European Patent Office national filings) with Yeda Research and Development Company Limited, or Yeda,

and one international patent family (United States, Europe) with both Keio and Yeda.

We have an exclusive license from Yeda and Keio for

these co-owned patent applications.

We have exclusive licenses from Yeda or Keio for the rest of the patents and patent applications in

its portfolio.

States, Australia, Canada, European Patent Office national filings) with Yeda Research and Development Company Limited, the technology

transfer office of the WIS, or Yeda, and one international patent family (United States, Europe) with both Keio and Yeda.

We have an exclusive

license from Yeda and Keio for these co-owned patent applications.

We have exclusive licenses from Yeda or Keio for the rest of the patents

and patent applications in its portfolio.

A significant portion of our portfolio is directed

to our product candidates, specifically:

CF, AD, IBD, PSC and CRC, as well as to our bacterial target discovery and bacteriophage discovery

technology platforms.

Prosecution has yet to commence for most of the pending patent applications covering our product candidates.

is a lengthy process, during which the scope of the claims initially submitted for examination by the USPTO are often significantly narrowed

by the time they issue, if they issue at all.

We expect this to be the case with respect to our licensed and co-owned patent applications,

described briefly below.

We solely own one patent family (PCT stage) containing

claims directed to pharmaceutical compositions comprising combinations of bacteriophage to treat chronic Pseudomonas lung infections,

especially common in CF patients, methods of use for these bacteriophage combinations, and methods of identifying patients who will respond

to these bacteriophage combinations.

Any United States patents issuing from the pending application covering our lead bacteriophage combination

in this program, if issued, are expected to expire in 2042.

Patent term adjustments or patent term extensions could result in later expiration

We solely own one patent family (PCT stage) containing

claims directed to pharmaceutical compositions comprising combinations of bacteriophage to treat skin infections, especially common in

AD patients, methods of use for these bacteriophage combinations, and methods of identifying patients who will respond to these bacteriophage

combinations.

Any United States patents issuing from the pending application covering our lead bacteriophage combination in this program,

if issued, are expected to expire in 2042.

Patent term adjustments or patent term extensions could result in later expiration dates.

We solely own one patent family (PCT stage), co-own

with Keio one US patent family and co-own with Keio and Yeda one international patent family (United States, Europe), containing claims

directed to pharmaceutical compositions comprising combinations of bacteriophage useful to treat IBD and other diseases of the gastrointestinal

tract, methods of use for these bacteriophage combinations, methods of identifying patients who will respond to these bacteriophage combinations,

and methods of treating IBD by targeting bacterial strains discovered to cause or contribute to that disease.

We also have an exclusive license from Keio for

an international patent family including patent applications in the United States, Australia, Canada, China, Europe and Japan.

These applications

are directed to methods of use for these bacteriophage combinations, methods of identifying patients who will respond to these bacteriophage

combinations, and methods of treating IBD by targeting a bacterial strain discovered to cause or contribute to that disease.

States patents issuing from the pending applications covering our lead bacteriophage combination in this program, if issued, are expected

to expire in 2037, 2038 or 2042.

Patent term adjustments or patent term extensions could result in later expiration dates.

We have an exclusive license to one United States

national patent application and two Japanese patent applications with claims directed to pharmaceutical compositions comprising bacterial

strains discovered to be beneficial in the treatment of PSC and methods of using the same, and to methods of treating PSC by reducing

the level of certain bacterial strains discovered to contribute to PSC.

Any United States patents issuing from the pending applications

in this program, if issued, are expected to expire in 2038 or 2039.

Patent term adjustments or patent term extensions could result in

later expiration dates.

We solely own one patent family (PCT stage), containing

claims directed to pharmaceutical compositions and formulations comprising combinations of bacteriophage (both synthetic and naturally

occurring) useful to treat cancer.

patent issuing from the pending application covering our lead bacteriophage combination in

this program, if issued, are expected to expire in 2041.

Patent term adjustments or patent term extensions could result in later expiration

CF and atopic dermatitis as well as product candidates relevant to programs which we have stopped

their development such as:

inflammatory bowel disease, or IBD, primary sclerosing cholangitis and colorectal cancer, or CRC, as well as

to our bacterial target discovery and bacteriophage discovery technology platforms.

Prosecution has yet to commence for most of the pending

patent applications covering our product candidates.

Prosecution is a lengthy process, during which the scope of the claims initially

submitted for examination by the USPTO are often significantly narrowed by the time they issue, if they issue at all.

We expect this to

be the case with respect to our licensed and co-owned patent applications, described briefly below.

In connection with the Acquisition, we further

enhanced our intellectual property portfolio with the addition of APT’s portfolio comprising of 7 issued or allowed patents, 19

patent families (including applications in United States, Europe, Australia, Canada, China, India, Japan, Korea, Israel, Brazil, and

South Africa).

APT’s patents and patent applications consist of patents and patent applications with respect to pharmaceutical compositions

and methods of treatment, methods of manufacture of such compositions and expire between June 2037 and October 2043.

We solely own one patent family (United States,

Australia, Canada, European Patent Office, Japan and China) containing claims directed to pharmaceutical compositions comprising combinations

of bacteriophage to treat chronic Pseudomonas lung infections, especially common in CF patients, methods of use for these bacteriophage

combinations, and methods of identifying patients who will respond to these bacteriophage combinations.

Any United States patents issuing

from the pending application covering our lead bacteriophage combination in this program, if issued, are expected to expire in 2042.

term adjustments or patent term extensions could result in later expiration dates.

Atopic Dermatitis

We solely own one patent family (United States,

Australia, Canada, European Patent Office and Japan) containing claims directed to pharmaceutical compositions comprising combinations

of bacteriophage to treat skin infections, especially common in atopic dermatitis patients, methods of use for these bacteriophage combinations,

and methods of identifying patients who will respond to these bacteriophage combinations.

Any United States patents issuing from the pending

application covering our lead bacteriophage combination in this program, if issued, are expected to expire in 2042.

Patent term adjustments

or patent term extensions could result in later expiration dates.

The term of individual patents depends upon the

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developing bacteriophage products to treat diseases.

To our knowledge, several biotechnology companies, such as Adaptive Phage Therapeutics,

Locus Biosciences, Inc., Armata Pharmaceuticals, Inc.

and SNIPR Biome, as well as academic institutions, have discovery stage or clinical

programs utilizing naturally occurring phage or synthetic biology approaches.

In addition, we are aware of several investigational and

marketed products to treat the indications that we are targeting with our product candidates, including, but not limited to:

To our knowledge, several biotechnology companies, such as Locus Biosciences, Inc.,

Armata Pharmaceuticals, Inc.

and SNIPR Biome, as well as academic institutions, have discovery stage or clinical programs utilizing naturally

occurring phage or synthetic biology approaches.

In addition, we are aware of several investigational and marketed products to treat the

indications that we are targeting with our product candidates, including, but not limited to:

Trikafta, Symdeco,

Pulmozyme, Tobramycin, Aztreonam

Elidel, Eucrisa,

Ruxolitinib, Dupixent

TP-102 being developed

by Technophage, a phage-based product being developed by Phaxiam

Many of our competitors, either alone or with their

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2021, we entered into a stock purchase agreement with a subsidiary of Maruho, a leading dermatology-focused pharmaceutical company in

Japan, pursuant to which we issued to Maruho 375,000 shares of our Common Stock, at a price of $8.00 per share for gross proceeds of $3

We also granted Maruho a right of first offer to license BX005 in Japan.

The right of first offer will commence following the

availability of results from the Phase 1/2 study.

Japan, pursuant to which we issued to Maruho 375,000 shares of Common Stock, at a price of $8.00 per share for gross proceeds of $3 million.

We also granted Maruho a right of first offer to license our BX005 product candidate for atopic dermatitis in Japan.

The right of first

offer will commence following the availability of results from a the Phase 1/2 study which is currently on hold.

Government Regulation

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of drug and biological products.

Generally, before a new drug or biologic can be marketed, considerable data demonstrating its quality,

safety, efficacy, purity, and/or potency must be obtained, organized into a format specific for each regulatory authority, submitted for

review and approved by the regulatory authority where the product is intended to be marketed.

Generally, before a new drug or biologic can be studied in human clinical trials or marketed, considerable

data demonstrating its quality, safety, efficacy, purity, and/or potency must be obtained, organized into a format specific for each regulatory

authority, submitted for review and approved by the regulatory authority where the product is intended to be studied or marketed.

Biological Product Development Process

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The process generally involves the following:

● Completion of extensive preclinical

studies in accordance with applicable regulations, including studies conducted in accordance with GLP requirements, if needed;

● Submission to the FDA of an

IND, which must become effective before human clinical trials may begin;

● Approval by an institutional

review board, or IRB, at each clinical trial site before each trial may be initiated;

● Performance of adequate and

well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practice, or GCP, requirements and

other clinical trial-related regulations to establish the safety, purity, potency and efficacy of the investigational product for each

proposed indication;

Completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with GLP requirements, if needed;

Submission to the FDA of an IND, which must become effective before human clinical trials may begin;

Approval by an institutional review board, or IRB, at each clinical trial site before each trial may be initiated;

Performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practice, or GCP, requirements and other clinical trial-related regulations to establish the safety, purity, potency and efficacy of the investigational product for each proposed indication;

Submission to the FDA of a BLA;

● A determination by the FDA within

60 days of its receipt of a BLA to accept the application for review;

● Satisfactory completion of an

FDA pre-approval inspection of the manufacturing facility or facilities where the biologic will be produced to assess compliance with

cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength,

quality and purity;

● Potential FDA audit of the clinical

trial sites that generated the data in support of the BLA;

● Payment of user fees for FDA

review of the BLA (unless a fee waiver applies);

● FDA review and approval of the

BLA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the biologic in

the United States.

A determination by the FDA within 60 days of its receipt of a BLA to accept the application for review;

Satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the biologic will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength, quality and purity;

Potential FDA audit of the clinical trial sites that generated the data in support of the BLA;

Payment of user fees for FDA review of the BLA (unless a fee waiver applies);

FDA review and approval of the BLA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the biologic in the United States.

Preclinical Studies and IND

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Clinical trials involve the administration of the

biological product candidate to healthy volunteers or disease-affected patients under the supervision of qualified investigators, generally

physicians not employed by, or under, the trial sponsor’s control.

Clinical trials are conducted under protocols detailing, among

other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to

be used to monitor subject safety and efficacy, including stopping rules that assure a clinical trial will be stopped if certain adverse

drug or biological product candidate to healthy volunteers or disease-affected patients under the supervision of qualified investigators,

generally physicians not employed by, or under, the trial sponsor’s control.

Clinical trials are conducted under protocols detailing,

among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters

to be used to monitor subject safety and efficacy, including stopping rules that assure a clinical trial will be stopped if certain adverse

events should occur.

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sequential phases, known as Phase 1, Phase 2 and Phase 3, and may overlap.

● Phase 1 clinical trials generally

involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple

doses of the product candidate.

The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, side

effect tolerability and safety of the product candidate.

● Phase 2 clinical trials generally

involve studies in disease-affected patients to evaluate proof of concept and/or determine the dosing regimen(s) for subsequent investigations.

At the same time, safety and sometimes further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects

and safety risks are identified and a preliminary evaluation of efficacy is conducted.

● Phase 3 clinical trials generally

involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness

of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide

an adequate basis for labeling for new drugs.

Phase 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate.

The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the product candidate.

Phase 2 clinical trials generally involve studies in disease-affected patients to evaluate proof of concept and/or determine the dosing regimen(s) for subsequent investigations.

At the same time, safety and sometimes further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified and a preliminary evaluation of efficacy is conducted.

Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for labeling for new drugs.

Post-approval trials, sometimes referred to as

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Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor,

known as a data safety monitoring board or committee.

This group provides authorization for whether a trial may move forward at designated

check points based on access to certain data from the trial.

or the Data Safety Monitoring Board.

This group provides authorization for whether a trial may move forward at designated check points

based on access to certain data from the trial.

Concurrent with clinical trials, companies may

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drug receives marketing approval for an indication broader than that which is designated, it may not be entitled to orphan drug exclusivity.

In December 2023, BX004, received orphan drug designation from the FDA.

Expedited Development and Review Programs

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Companion Diagnostics

We may employ companion diagnostics to help it

to more accurately identify patients within a particular bacterial strain, both during our clinical trials and in connection with the

commercialization of our product candidates that we are developing or may in the future develop.

Companion diagnostics can identify patients

who are most likely to benefit from a particular therapeutic product;

identify patients likely to be at increased risk for serious side

effects as a result of treatment with a particular therapeutic product;

or monitor response to treatment with a particular therapeutic

product for the purpose of adjusting treatment to achieve improved safety or effectiveness.

Companion diagnostics are regulated as medical

devices by the FDA and, as such, require either clearance or approval prior to commercialization.

The level of risk combined with available

controls to mitigate risk determines whether a companion diagnostic device requires Premarket Approval Application approval or is cleared

through the 510(k) premarket notification process.

For a novel therapeutic product for which a companion diagnostic device is essential

for the safe and effective use of the product, the companion diagnostic device should be developed and approved or 510(k)-cleared contemporaneously

with the therapeutic.

The use of the companion diagnostic device will be stipulated in the labeling of the therapeutic product.

We may employ companion diagnostics to identify

the most suitable phage to treat a specific patient under our personalized phage treatments and to help more accurately identify patients

sensitive to our phage cocktails, during our clinical trials and potentially also in connection with the commercialization of our product

candidates that we are developing or may in the future develop.

Companion diagnostics can identify patients who are most likely to benefit

from a particular therapeutic product;

identify patients likely to be at increased risk for serious side effects as a result of treatment

with a particular therapeutic product;

or monitor response to treatment with a particular therapeutic product for the purpose of adjusting

treatment to achieve improved safety or effectiveness.

Companion diagnostics are regulated as medical devices by the FDA and, as such,

require either clearance or approval prior to commercialization.

The level of risk combined with available controls to mitigate risk determines

whether a companion diagnostic device requires Premarket Approval Application approval or is cleared through the 510(k) premarket notification

For a novel therapeutic product for which a companion diagnostic device is essential for the safe and effective use of the product,

the companion diagnostic device should be developed and approved or 510(k)-cleared contemporaneously with the therapeutic.

the companion diagnostic device will be stipulated in the labeling of the therapeutic product.

Government Regulation Outside of the United States

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In the European Union, for example, a clinical trial application, or CTA, must be submitted

for each clinical trial to the national health authority and an independent ethics committee in each country in which the trial is to

be conducted, much like the FDA and an IRB, respectively.

CTAs must be accompanied by an investigational medicinal product dossier with

supporting information prescribed by the Clinical Trials Directive (and corresponding national laws of the member states) and further

detailed in applicable guidance documents.

Once the CTA is approved in accordance with a country’s requirements, the clinical trial

A similar process to the one described for the European Union is required in Israel for initiation of clinical trials.

requirements and process governing the conduct of clinical trials vary from country to country.

In all cases, the clinical trials must

be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the

Declaration of Helsinki.

for each clinical trial to the relevant national health authority and an independent ethics committee in each country in which the trial

is to be conducted through a single EU portal for harmonized assessment, much like the FDA and an IRB, respectively.

CTAs must be accompanied

by an investigational medicinal product dossier with supporting information prescribed by the Clinical Trials Directive (and corresponding

national laws of the member states) and further detailed in applicable guidance documents.

Once the CTA is approved in accordance with

a country’s requirements, the clinical trial may proceed.

A similar process to the one described for the European Union is required

in Israel for initiation of clinical trials.

The requirements and process governing the conduct of clinical trials vary from country to

In all cases, the clinical trials must be conducted in accordance with GCP and the applicable regulatory requirements and the

ethical principles that have their origin in the Declaration of Helsinki.

Approval Process

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the accelerated approval:

EMA may reduce the maximum timeframe for the evaluation of an MAA from 210 days to 150 days when the future medicinal product is of major

interest from the point of view of public health, in particular from the viewpoint of therapeutic innovation.

the EMA may reduce the maximum timeframe for the evaluation of an MAA from 210 days to 150 days when the future medicinal product is of major interest from the point of view of public health, in particular from the viewpoint of therapeutic innovation.

the conditional marketing authorization:

as part of its marketing authorization process, the European Commission may grant marketing authorizations on the basis of less complete

data than is normally required.

as part of its marketing authorization process, the European Commission may grant marketing authorizations on the basis of less complete data than is normally required.

A conditional marketing authorization may be granted

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been supplied, all the following requirements are met:

● the risk/benefit balance of

the medicinal product is positive;

● it is likely that the applicant

will be in a position to provide the comprehensive clinical data;

● unmet medical needs will be

● the benefit to public health

of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional

data is still required.

the risk/benefit balance of the medicinal product is positive;

it is likely that the applicant will be in a position to provide the comprehensive clinical data;

unmet medical needs will be addressed;

the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data is still required.

The granting of a conditional marketing authorization

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The laws that may affect our ability to operate include:

● the federal Anti-Kickback Statute,

which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any

kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the

referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may

be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs;

a person or entity does

not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation.

In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback

Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act or federal civil money penalties statute;

● federal civil and criminal false

claims laws and civil monetary penalties laws, such as the federal False Claims Act, which impose criminal and civil penalties and authorize

civil whistleblower or qui tam actions, against individuals or entities for, among other things:

knowingly presenting, or causing to

be presented, to the federal government, claims for payment that are false or fraudulent;

making, using or causing to be made or used,

a false statement or record material to a false or fraudulent claim or obligation to pay or transmit money or property to the federal

the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs;

a person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation.

In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act, or FCA, or federal civil money penalties statute;

federal civil and criminal false claims laws and civil monetary penalties laws, such as the FCA, which impose criminal and civil penalties and authorize civil whistleblower or qui tam actions, against individuals or entities for, among other things:

knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent;

making, using or causing to be made or used, a false statement or record material to a false or fraudulent claim or obligation to pay or transmit money or property to the federal government;

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

● the civil monetary penalties

law, which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of

items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the

person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of items or services reimbursable

by a federal or state governmental program;

● HIPAA, which created new federal

criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit

program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or

under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and

willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection

with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

similar to the federal Anti-Kickback

Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed

● the federal transparency requirements

under the Affordable Care Act, or ACA, including the provision commonly referred to as the Physician Payments Sunshine Act, which requires

manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s

Health Insurance Program to report annually to the U.S.

Department of Health and Human Services information related to payments or other

transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician

practitioners (physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered

nurse anesthetists and certified nurse midwives) and teaching hospitals, as well as ownership and investment interests held by the physicians

described above and their immediate family members;

● federal government price reporting

laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs;

● federal consumer protection

and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.

the civil monetary penalties law, which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of items or services reimbursable by a federal or state governmental program;

the Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

the federal transparency requirements under the Affordable Care Act, or ACA, including the provision commonly referred to as the Physician Payments Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the U.S.

Department of Health and Human Services information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members;

federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs;

federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.

Additionally, we are subject to state and foreign

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the ability to bring actions on behalf of the U.S.

government under the federal False Claims Act as well as under the false claims laws

of several states.

government under the federal FCA, as well as under the false claims laws of several

Law enforcement authorities are increasingly focused

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civil or administrative sanctions, including exclusions from government funded healthcare programs, which may also adversely affect our

Much like the Anti-Kickback Statute prohibition

in the United States, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement,

Much like the federal Anti-Kickback Statute in

the United States, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement,

purchase, supply, order or use of medicinal products is also prohibited in the European Union.

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Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

Since its enactment, there have been a number of significant

changes to the ACA.

Since its enactment, there have been a number of

significant changes to the ACA.

On June 17, 2021, the U.S.

Supreme Court dismissed the most recent judicial challenge to the ACA without specifically

ruling on the constitutionality of the ACA.

Prior to the Supreme Court’s decision, President Biden issued an executive order initiating

a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage

through the ACA marketplace.

The executive order also instructed certain governmental agencies to review and reconsider their existing

policies and rules that limit access to healthcare.

More recently, on March 11, 2021, President Biden signed the American Rescue

Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average

manufacturer price, beginning January 1, 2024.

In addition, the Budget Control Act of 2011 and the

Bipartisan Budget Act of 2015 led to aggregate reductions of Medicare payments to providers of 2% per fiscal year that will remain in

effect through 2030, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022 and a 1% reduction from April

1, 2022 through June 30, 2022, unless additional Congressional action is taken.

Further, on January 2, 2013, the American Taxpayer Relief

Act was signed into law, which, among other things, reduced Medicare payments to several types of providers, including hospitals, imaging

Supreme Court dismissed the most recent judicial challenge to the ACA

without specifically ruling on the constitutionality of the ACA.

Prior to the U.S.

Supreme Court’s decision, President Biden issued

an executive order initiating a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining

health insurance coverage through the ACA marketplace.

The executive order also instructed certain governmental agencies to review and

reconsider their existing policies and rules that limit access to healthcare.

More recently, on March 11, 2021, President Biden signed

the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of

a drug’s average manufacturer price, beginning January 1, 2024.

In addition, the Budget Control Act of 2011 and

the Bipartisan Budget Act of 2015 led to aggregate reductions of Medicare payments to providers of 2% per fiscal year that will remain

in effect through 2030, unless additional Congressional action is taken.

Further, on January 2, 2013, the American Taxpayer Relief Act

was signed into law, which, among other things, reduced Medicare payments to several types of providers, including hospitals, imaging

centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers

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In the United States, numerous federal and state laws and regulations, including data

breach notification laws, health information privacy and security laws, including Health Insurance Portability and Accountability Act

of 1996, or HIPAA, and federal and state consumer protection laws and regulations (e.g., Section 5 of the FTC Act), that govern the collection,

use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our

breach notification laws, health information privacy and security laws, including HIPAA, and federal and state consumer protection laws

and regulations (e.g., Section 5 of the FTC Act), that govern the collection, use, disclosure, and protection of health-related and other

personal information could apply to our operations or the operations of our partners.

In addition, certain state and non-U.S.

laws, such as the California Consumer Protection Act, the California Privacy Rights

Act, and the General Data Protection Regulation, or GDPR, govern the privacy and security of personal information, including health-related

information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant

ways and may not have the same effect, thus complicating compliance efforts.

Failure to comply with these laws, where applicable, can

result in the imposition of significant civil and/or criminal penalties and private litigation.

Privacy and security laws, regulations,

and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations,

proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.

as the California Consumer Protection Act, the California Privacy Rights Act, and the General Data Protection Regulation, or GDPR, govern

the privacy and security of personal information, including health-related information in certain circumstances, some of which are more

stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating

compliance efforts.

Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal

penalties and private litigation.

Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict

with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil

and/or criminal penalties and restrictions on data processing.

Material Agreements

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On June 22, 2015, BiomX Ltd.

entered into the Research

and License Agreement, with Yeda, or, as amended, the Yeda 2015 License Agreement, the technology transfer office of the WIS, pursuant

to which BiomX Ltd.

received an exclusive worldwide license to certain know-how and research information related to the development, testing,

manufacturing, production and sale of microbiome-based therapeutic product candidates, including candidates specified in the agreement,

which are used in our phage discovery platform, as well as patents, research and other rights to phage product candidates resulting from

the work of the consultants identified in the agreement and further research conducted at the WIS which BiomX Ltd.

In connection with this license, we are to pay a non-refundable

license fee of $10,000 per year.

entered into a Research

and License Agreement, with Yeda , or, as amended, the Yeda 2015 License Agreement, pursuant to which BiomX Ltd.

received an exclusive

worldwide license to certain know-how and research information related to the development, testing, manufacturing, production and sale

of microbiome-based therapeutic product candidates, including candidates specified in the agreement, which are used in our phage discovery

platform, as well as patents, research and other rights to phage product candidates resulting from the work of the consultants identified

in the agreement and further research conducted at the WIS which BiomX Ltd.

In connection with this license, BiomX Ltd.

to pay a non-refundable license fee of $10,000 per year.

In addition, BiomX Ltd.

contributed an aggregate of approximately $2.0 million to the research budget

agreed upon in the Yeda 2015 License Agreement.

We are also required to pay tiered royalties in the low single digits on net sales of

products and diagnostic kits covered by the Yeda 2015 License Agreement, subject to reductions as described therein.

The products and

diagnostic kits covered by the license agreement include those directed to IBD, CRC, and any other indications that may be treated by

phage-based therapies, as well as related technology platforms.

If we sublicense our rights under this agreement we will be obligated

to pay Yeda additional sublicense royalties expressed as a percentage of the sublicensing receipts described in the agreement received

ranging from the mid-teens to the mid-twenties.

We are obligated to pay filing and maintenance expenses in respect of patents licensed

under the Yeda 2015 License Agreement.

contributed an aggregate of approximately $2.0 million

to the research budget agreed upon in the Yeda 2015 License Agreement.

BiomX Ltd is also required to pay tiered royalties in the low single

digits on net sales of products and diagnostic kits covered by the Yeda 2015 License Agreement, subject to reductions as described therein.

The products and diagnostic kits covered by the license agreement include those directed to CF and any other indication that may be treated

by phage-based therapies, as well as related technology platforms.

If BiomX Ltd.

sublicenses its rights under the Yeda 2015 License Agreement,

will be obligated to pay Yeda additional sublicense royalties expressed as a percentage of the sublicensing receipts described

in the agreement received ranging from the mid-teens to the mid-twenties.

is obligated to pay filing and maintenance expenses

in respect of patents licensed under the Yeda 2015 License Agreement.

In connection with the Yeda 2015 License Agreement, BiomX Ltd.

also issued certain ordinary shares

which were subsequently converted to 193,406 shares of our Common Stock as part of the Business Combination (as defined below).

event of certain mergers and acquisitions we are party to, we are obligated to pay Yeda an amount equivalent to 1% of the consideration

received under such transaction.

issued certain ordinary shares which were subsequently converted to 193,406 shares of our Common Stock as part of the Business Combination.

In the event of certain mergers and acquisitions we are party to, we are obligated to pay Yeda an amount equivalent to approximately 1%

of the consideration received under such transaction.

Unless terminated earlier by either party, the

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a first commercial sale of any product in any country.

Yeda may also terminate the agreement if we fail to observe certain diligence and

development requirements and milestones as described in the agreement.

We or Yeda may terminate the agreement for the material uncured

breach of the other party after a notice period, or the other party’s winding up, bankruptcy, insolvency, dissolution or other similar

discontinuation of business.

Upon termination of the agreement, other than due to the passage of time, we are required to grant to Yeda

a non-exclusive, irrevocable, perpetual, fully paid-up, sublicensable, worldwide license in respect of our rights in know-how and research

results as described in the Yeda 2015 License Agreement, provided that if Yeda subsequently grants a license to a third party that utilizes

our rights, we are entitled to share in the net proceeds actually received by Yeda arising out of that license, subject to a cap based

on the development expenses that we incur in connection with the Yeda 2015 License Agreement.

We consult with Yeda with respect to patent prosecution

and maintenance decisions.

Yeda is primarily responsible for prosecution and maintenance with respect to Licensed Information (as defined

in the license) and we are responsible for prosecution and maintenance with respect to Subsequent Results (as defined in the license).

We and Yeda are both entitled to consultation rights.

We are responsible for costs associated with prosecution and maintenance of all

patents and applications.

We are entitled to enforce the patent rights under

the license upon approval by Yeda.

Yeda may also terminate the agreement if BiomX Ltd.

fails to observe certain diligence

and development requirements and milestones as described in the Yeda 2015 License Agreement.

or Yeda may terminate the Yeda

2015 License Agreement for the material uncured breach of the other party after a notice period, or the other party’s winding up,

bankruptcy, insolvency, dissolution or other similar discontinuation of business.

Upon termination of the Yeda 2015 License Agreement,

other than due to the passage of time, BiomX Ltd.

is required to grant to Yeda a non-exclusive, irrevocable, perpetual, fully paid-up,

sublicensable, worldwide license in respect of our rights in know-how and research results as described in the Yeda 2015 License Agreement,

provided that if Yeda subsequently grants a license to a third party that utilizes our rights, BiomX Ltd.

is entitled to share in the

net proceeds actually received by Yeda arising out of that license, subject to a cap based on the development expenses that BiomX incurs

in connection with the Yeda 2015 License Agreement.

consults with Yeda with respect to patent

prosecution and maintenance decisions.

Yeda is primarily responsible for prosecution and maintenance with respect to Licensed Information

(as defined in the license) and we are responsible for prosecution and maintenance with respect to Subsequent Results (as defined in the

and Yeda are both entitled to consultation rights.

BiomX is responsible for costs associated with prosecution and

maintenance of all patents and applications.

is entitled to enforce the patent rights

under the license upon approval by Yeda.

Yeda may elect to join the lawsuit, but we are responsible for all litigation-related expenses.

reserves the right to bring its own actions if we do not notify Yeda of our intent to enforce a right or bring an action after we initially

notified Yeda of the potential action.

Exclusive Patent License Agreement with Keio

and JSR Corporation, or JSR, for IBD

entered into an Exclusive Patent License

Agreement with Keio, and JSR on December 15, 2017, as amended, pursuant to which BiomX Ltd.

was granted an exclusive, royalty-bearing,

worldwide, perpetual sublicense by JSR to certain patent rights related to our IBD program.

Specifically, these patent rights relate to

bacterial targets that have been observed to be related to IBD and the phage that were observed to eradicate these bacterial targets.

We paid JSR a license issue fee of $10,000 and

have agreed to pay annual fees ranging from $15,000 to $25,000 in each subsequent year.

In addition to the license fees, we have agreed

to make payments upon the satisfaction of certain clinical and regulatory milestones up to an aggregate of $3.2 million, of which $40,000

was paid in February 2021.

We are also required to pay tiered royalties expressed as a percentage of annual net sales of products developed

under the agreement in the low single digits.

If we sublicense our rights under this agreement, we will be obligated to pay sublicense

royalties expressed as a percentage of sublicense income received, including any license signing fee, license maintenance fee, distribution

or joint marketing fee and milestone payments, ranging in the high single digits to the low teens.

Our payments under this agreement are

subject to reductions as set forth therein.

Unless earlier terminated, this agreement will

expire on the later of the date on which all issued patents and filed patent applications have expired (which is expected to be in 2039),

or been abandoned, withdrawn, rejected, revoked or invalidated, and five years from the date of first commercial sale of a product developed

under the agreement in any country or, if later, when the product ceases to be covered by a valid claim in the United States, European

Union or Japan.

JSR may terminate this agreement if we fail to pay the amounts due under this agreement, or upon our winding up, bankruptcy,

insolvency, dissolution or other similar discontinuation of business, or if we breach the material terms of this agreement and such breach

We may terminate this agreement at any time upon three months’ advance written notice to JSR.

We, Keio and JSR are responsible for maintenance

and prosecution of patents that are to be jointly owned by the parties.

JSR is entitled to the opportunity to advise and approve decisions

that would have a material adverse impact on the scope of the claims.

JSR is responsible for patents that are listed in such agreement

and we are entitled to advise with respect to patent counsel, scope of claims, and other matters.

We are entitled to bring enforcement

actions (in our name alone and at our own expense).

We are required to obtain JSR’s prior written consent for each action we bring

with respect to the Patent Rights only.

Exclusive Patent License Agreement with Keio

and JSR for PSC

We entered into an additional Exclusive Patent

License Agreement with Keio and JSR on April 22, 2019, pursuant to which we were granted an exclusive, royalty-bearing, worldwide, perpetual

sublicense by JSR to certain patent rights related to our PSC program.

Specifically, these patent rights relate to bacterial targets that

have been observed to be related to PSC and the phage that were observed to eradicate these bacterial targets.

We paid JSR a license issue fee of $20,000 and

have agreed to pay annual fees ranging from $15,000 to $25,000 in each subsequent year.

In addition to the license fees, we have agreed

to make payments upon the satisfaction of certain clinical and regulatory milestones up to an aggregate amount of $3.2 million.

also required to pay tiered royalties expressed as a percentage of annual net sales of products developed under the agreement in the

low single digits.

If we sublicense our rights under this agreement, we will be obligated to pay sublicense royalties expressed as a

percentage of sublicense income received, including any license signing fee, license maintenance fee, distribution or joint marketing

fee and milestone payments, ranging in the high single digits to the low teens.

Our payments under this agreement are subject to reductions

as set forth therein.

Unless earlier terminated, this agreement will

expire on the later of the date on which all issued patents and filed patent applications have expired (which is expected to be in 2039),

or been abandoned, withdrawn, rejected, revoked or invalidated, and five years from the date of first commercial sale of a product developed

in connection with this agreement in any country or, if later, when the product ceases to be covered by a valid claim in the United States,

European Union or Japan.

JSR may terminate this agreement if we fail to pay the amounts due under this agreement, or upon our winding

up, bankruptcy, insolvency, dissolution or other similar discontinuation of business, or if we breach the material terms of this agreement

and such breach is uncured.

We may terminate this agreement at any time upon three months’ advance written notice to JSR.

We, Keio and JSR are responsible for maintenance

and prosecution of patents that are to be jointly owned by the parties.

JSR is entitled to the opportunity to advise and approve decisions

that would have a material adverse impact on the scope of the claims.

JSR is responsible for patents that fall under Patent Rights and

we are entitled to advise with respect to patent counsel, scope of claims, and other matters.

We are entitled to bring enforcement actions

(in our name alone and at our own expense).

Yeda reserves the right to bring its own actions if we do not notify Yeda of our intent to enforce a right or bring an action after we

initially notified Yeda of the potential action.

Exclusive License with United States Navy

On March 16, 2017, APT entered into an exclusive

license (as amended on January 10, 2019, or the USN License Agreement, with the United States of America, as represented by the Secretary

of the Navy or the USN, pursuant to which APT received an exclusive license throughout the territory encompassing the United States, Canada

and Europe to an invention entitled “Bacteriophage Compositions and Method of Selection of Components Against Specific Bacteria

or the USN Licensed Patent, as well as associated materials, including approximately 350 phage (or collectively with the USN Licensed

Patent, the USN Materials), in the field of treating and/or eliminating multi-drug resistant bacteria for all uses, including industrial

or medical uses.

Pursuant to the USN License Agreement, APT agreed to carry out a commercial development plan or the Commercial Development

Plan, for the development and marketing of an invention claimed or disclosed in the USN Licensed Patent or a Licensed Invention, to bring

a Licensed Invention to practical application consistent with the milestones provided in the Commercial Development Plan by December 31,

2022, and, thereafter, to continue to make the benefits of a Licensed Invention reasonably accessible to the public for the remainder

of the term of the USN License Agreement.

For the term of the license, any Licensed Invention or product produced through the use of a

Licensed Invention for use or sale in the United States must be manufactured substantially in the United States.

The Company uses the

phage provided in connection with the USN License Agreement as a potential source of phage for the development of its phage treatments.

In connection with the USN License Agreement, APT

paid the USN a license execution royalty of $5,000.

We are also required to pay royalties expressed as a percentage in the high single

digits on net sales of products, or Royalty-Bearing Products (i) defined by or containing a composition defined by any claim of the USN

Licensed Patent, (ii) made by a method claimed in a Licensed Invention, (iii) based on, originating from or containing USN Materials,

or (iv) based on, originating from or supported by USN-created information not found within the USN Licensed Patent and used to support

the commercialization or regulatory approval of a Royalty-Bearing Product, including, DNA sequence data, clinical trial data and detailed

laboratory methods, related to the Licensed Invention.

APT agreed to pay minimum annual royalties in the

amount of $5,000 from 2018 to 2020 and $20,000 thereafter.

APT also agreed to pay (a) a regulatory approval royalty in the low $100,000s

within 180 days of receiving FDA approval to market a Royalty-Bearing Product and (b) a revenue milestone royalty in the low $100,000s

when certain revenue thresholds have been met.

Additionally, we agreed to pay royalties expressed as a percentage in the mid-twenties

of all revenue received from sublicensing any Royalty-Bearing Product.

We are responsible for controlling and diligently

prosecuting the USN Licensed Patent and paying all costs associated with prosecuting and maintaining the USN Licensed Patent in the United

States and in foreign jurisdictions.

We agreed to submit annual progress reports on our efforts to achieve a practical application of

the Licensed Invention by January 1, 2021, and thereafter until such practical application has been received.

We may terminate the USN License Agreement upon

120 days’ written notice, and the USN may terminate the USN License Agreement if (i) the USN determines we are not executing the

Commercial Development Plan, (ii) the USN determines such termination is necessary to meet requirements for public use specified by U.S.

federal regulations issued after the date of the USN License Agreement and not reasonably satisfied by us, (iii) in the event we willfully

made a material false statement or omitted a material fact in our application for the USN License Agreement or any report required thereby,

or (iv) we commit a substantial material breach of the USN License Agreement that has not been remedied within 30 days of written notice.

License Agreement with Walter Reed Army Institute

On August 24, 2021, APT entered into a Biological

Materials License Agreement (or, as modified on August 31, 2022, the WRAIR License Agreement) with Walter Reed Army Institute of Research

or WRAIR, pursuant to which APT received a nonexclusive worldwide license to certain materials and information, including approximately

100 phage, or WRAIR Materials, to develop and commercialize phage products to treat/prevent Pseudomonas aeruginosa , Acinebactor

baumannii , Staphylococcus aureus , Klebsiella pneumonia , wound and UTI Escherichia coli and Enterobacter cloacae

bacterial infections.

The Company uses the phage provided in connection with the WRAIR License Agreement as a potential source of

phage for the development of its phage treatments.

In connection with the WRAIR License Agreement,

APT paid WRAIR an initial execution fee in the mid-thousands of dollars and agreed to pay a maintenance fee in the mid-thousands of dollars

We are also required to pay royalties expressed as a percentage in the low single digits on net sales of products that incorporate

the WRAIR Materials, or the WRAIR Licensed Products, subject to reductions as described in the WRAIR License Agreement.

In addition, if

we sublicense our rights under the WRAIR License Agreement we are obligated to pay WRAIR additional sublicense royalties expressed as

a percentage in the low teens of the sublicensing receipts we receive from any such sublicense royalties.

In addition, additional royalties

in the low teens may be assessed on any overdue royalty payments.

We are obligated to make written annual progress

reports to WRAIR, detailing our efforts to bring any inventions licensed under WRAIR License Agreement to the point of practical application,

together with any additional information requested by WRAIR or as contemplated or required under the development plan.

As part of our

performance under the WRAIR License Agreement, we have agreed to dose the first patient in a clinical trial with a WRAIR Licensed Product

within four years from the effective date of the WRAIR License Agreement.

In the event WRAIR files a non-provisional patent

application covering the WRAIR Materials and/or the use thereof, provided as part of this License Agreement, WRAIR is obligated to notify

us, and we and WRAIR will assess the need and/or desirability of a patent license.

In such case, we will have the first right of refusal

to negotiate a non-exclusive or exclusive license.

The WRAIR License Agreement will expire as to each

WRAIR Material ten years from the date that such WRAIR Material was added to the WRAIR License Agreement unless earlier terminated in

accordance with its terms.

We may terminate the WRAIR License Agreement upon 60 days’ written notice, and WRAIR may terminate if

we are in default and such default has not been remedied within 90 days after written notice of such default.

As of December 31, 2023, we had 58 full-time

employees and 13 part time employees.

Sixteen of our employees have Ph.D.

degrees and 50 of our employees are currently engaged

in research and development and clinical activities.

21 of our employees have Ph.D.

degrees and 53 of our employees are currently engaged in

research and development and clinical activities.

None of our employees is represented by labor unions or covered by collective bargaining

We consider our relationship with our employees to be very strong.

In May 2022, we announced, as part of our corporate restructuring plan,

our intention to reduce our operating costs, including a 50% reduction in personnel, while prioritizing our ongoing CF program.

In response to the COVID-19 pandemic, we implemented

significant changes designed to ensure the safety and well-being of our employees as well as the communities in which we operate.

not laid off any employees due to the pandemic.

We implemented additional safety measures including masks and social distancing protocols

in our offices and encouraged remote working arrangements for employees.

To date, our remote working arrangements have not significantly

affected our ability to maintain critical business operations.

We consider our relationship with our employees to be strong.

Corporate Information

3 unchanged sentences

is www.biomx.com.

The content of our website is not intended to be incorporated by reference into this report or in any other report or

document we file and any references to these websites are intended to be inactive textual references only.

Information About Our Executive Officers

The following table sets forth information regarding

our executive officers as of the date of this Annual Report:

Jonathan Solomon

Chief Executive Officer and Director

Chief Business Officer

Chief Development Officer

Marina Wolfson

Chief Financial Officer

Jonathan Solomon has served as the

Chief Executive Officer and as a director of the Company since October 2019.

Solomon served as Board member of BiomX Ltd.

from February

2016 and also as Chief Executive Officer from February 2017 to October 2019.

From July 2007 to December 2015, Mr.

Solomon was a co-founder,

President, and Chief Executive Officer of ProClara Biosciences Inc.

(formerly NeuroPhage Pharmaceuticals Inc.), a biotechnology company

pioneering an approach to treating neurodegenerative diseases.

Prior to joining ProClara, he served for ten years in a classified military

unit of the Israeli Defense Forces.

Solomon holds B.Sc.

magna cum laude in Physics and Mathematics from the Hebrew University, an

summa cum laude in Electrical Engineering from Tel Aviv University, and an MBA with honors from the Harvard Business School.

Assaf Oron has served as the Chief

Business Officer of the Company since October 2019.

Oron served as Chief Business Officer of BiomX Ltd.

from January 2017 to October

Prior to this position, he served in various roles at Evogene Ltd.

(Nasdaq:EVGN), an agriculture biotechnology company, which utilizes

a proprietary integrated technology infrastructure to enhance seed traits underlying crop productivity, from March 2006 to December 2016,

including Executive Vice President of Strategy and Business Development and Executive Vice President of Corporate Development.

joining Evogene, Mr.

Oron served as Chief Executive Officer of ChondroSite Ltd., a biotechnology company that develops engineered tissue

products in the field of orthopedics and as a senior project manager and strategic consultant at Israeli management consulting company

Oron holds an M.Sc.

in Biology (bioinformatics) and a B.Sc.

in Chemistry and Economics, both from Tel Aviv University.

Merav Bassan has served as the

Chief Development Officer of the Company since October 2019.

Prior to this position, she served in various development roles at Teva Pharmaceutical

Industries Limited between 2005 and 2019, including Vice President, Head of Translational Sciences, Specialty Clinical Development R&D

from 2017 to 2019, Vice President, Pain and Global Internal Medicine, Project Leadership, Innovative Product Development, Global IR&D

from 2015 to 2017, and Project Champion, Senior Director, Innovative Product Development, Global IR&D from 2009 to 2015.

holds a B.Sc.

in Biology, a M.Sc.

in Human Genetics and a Ph.D.

in Neurobiology from Tel Aviv University, and she completed a Post-Doctoral

Fellowship in Neuroscience at Harvard Medical School at Harvard University.

Marina Wolfson has served as the Chief

Financial Officer of the Company since April 2022.

Wolfson served in several finance and operations roles in the Company from December

2019 to March 2022.

Wolfson’s experience includes working with large pharmaceutical and hi-tech companies, as well as venture

capital funds.

Prior to joining the Company, Ms.

Wolfson worked as Vice President of Finance at BioView Ltd.

(TASE:BIOV) from 2010 to

2019 and a senior auditor at Ernst & Young, from 2007 to 2010.

Wolfson is a certified public accountant in Israel and holds

a B.A in Economics and Accounting (with honors) and an MBA (with honors, specializing in finance) from Ben-Gurion University.

The content of our website is not intended to be incorporated by reference into this Annual Report or in any other report

or document we file and any references to these websites are intended to be inactive textual references only.

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