What changed in this filing

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Item 1. Business

2022-09-15 compared with 2021-09-15 · 101 added, 212 removed, 14 unchanged (96% of the section changed)

Rezolute, Inc.

Rezolute ”,

Company ”, “

us ”) is a clinical-stage biopharmaceutical company developing

transformative therapies for metabolic diseases related to chronic glucose imbalance.

In October 2020 we completed a private placement

of equity securities that resulted in net proceeds to the Company of approximately $37.4 million.

Also in October 2020, our Board of Directors (our

Board of Directors ”

or our “

Board ”) approved a one share for every fifty shares reverse stock split

of our common stock (the “

Reverse Stock Split ”).

The Reverse Stock Split was previously approved by shareholders at

our annual meeting on October 23, 2019 and was effective at 5:00 PM EST on October 9, 2020.

The first day of trading after the Reverse

Stock Split was on October 13, 2020.

In connection with the Reverse Stock Split, proportionate adjustments were made to increase the per

share exercise prices and decrease the number of shares of common stock issuable upon exercise of stock options and warrants whereby approximately

the same aggregate price is required to be paid for such securities upon exercise as had been payable immediately preceding the Reverse

In addition, any fractional shares that would otherwise be issued as a result of the Reverse Stock Split were rounded up

to the nearest whole share.

All references in this Annual Report to the number of shares of common stock and the related per share amounts

have been retroactively adjusted to give effect to the Reverse Stock Split.

In September 2020, we made adjustments to the

composition of our Board of Directors, which included appointing Philippe Fauchet as an independent director.

Furthermore, in March 2021,

our Board of Directors appointed Dr.

Kreher and Dr.

Wladimir Hogenhuis as independent directors.

Our board consists of a majority

of independent directors.

In November 2020, our application to the Nasdaq

Capital Markets was approved and we began trading on this market under the “RZLT”

In December 2020, we entered into an Equity Distribution

Agreement (“

EDA ”) with Oppenheimer & Co.

Inc., pursuant to which we may offer and sell, from time to time, shares

of the our common stock, par value $0.001 per share, having an aggregate offering price of up to $50.0 million.

August 2021, we sold 138,388 shares of our common stock pursuant to the EDA at an average price per share of $10.78 for net proceeds of

approximately $1.5 million.

In April 2021, we entered into a Loan and Security

Agreement (the “

Loan Agreement ”) with SLR Investment Corp.

SLR ”) and certain other lenders (the

Lenders ”) that provided for total borrowings up to $30.0 million in three tranches.

The initial tranche of funding

for $15.0 million was received in April 2021.

Under the Loan Agreement, we are required to maintain a restricted cash balance of at least

$5.0 million beginning no later than December 31, 2021.

The second tranche for $7.5 million is available upon our request by January 2022,

and the third tranche for $7.5 million is available upon our request by September 2022.

Access to the additional borrowings under the

second and third tranches is subject to our ability by the requested funding date to raise cumulative equity or subordinated debt financing

of $35.0 million and $70.0 million, respectively, and the achievement of certain clinical milestones related to RZ358 and RZ402.

permitted to make interest-only payments on each term loan at least through May 1, 2023, and the maturity date is on April 1, 2026.

In June 2021, we merged with and into our wholly

owned subsidiary, Rezolute Nevada Merger Corporation, a Nevada corporation (“

Merger Sub ”), pursuant to an Agreement

and Plan of Merger, dated as of June 18, 2021 (the “

Reincorporation Merger Agreement ”), between us and Merger Sub,

with Merger Sub as the surviving corporation (the “

Reincorporation Merger ”).

At the effective time of the Reincorporation

Merger (the “

Effective Time ”), the Merger Sub was renamed “Rezolute, Inc.”

and succeeded to the assets,

continued our business and assumed our rights and obligations by operation of law.

The Reincorporation Merger Agreement was approved by

our shareholders at the 2021 annual meeting of our shareholders held on May 26, 2021.

(“Rezolute”, the “Company”, “we” or “us”) is a clinical-stage biopharmaceutical company developing therapies for metabolic diseases related to chronic glucose imbalance.

Summary of Clinical Assets

Our lead clinical asset, RZ358, is an

antibody therapy in Phase 2b development as a potential treatment for congenital hyperinsulinism (“

HI ”), an

ultra-rare pediatric genetic disorder.

In February 2020, we announced the initiation of the RZ358-606 Phase 2b study

RIZE ”) globally at multiple study centers.

Prior to COVID-19, we had planned to complete the RIZE study by the

middle of calendar year 2021.

In March 2020, we paused the RIZE study as a result of the COVID-19 pandemic.

In January 2021, as the

COVID-19 pandemic began to abate in different regions, we resumed clinical activities including trial site initiations and patient

Subject to COVID-19 conditions, we are expecting to substantially complete enrollment in the RIZE study by the end of

calendar year 2021 and have top-line data in the first quarter of calendar year 2022.

In addition, in the first half of calendar year

2020, we had positive interactions with the U.S.

Food and Drug Administration (“

FDA ”).

In June 2020, we announced that

FDA granted us Rare Pediatric Disease (“

RPD ”) designation for RZ358, which qualifies us to receive a priority review

voucher (“PRV”) upon marketing approval of the drug in HI.

Such a voucher could be redeemed to receive a priority review of

a subsequent marketing application for any drug candidate in any disease indication.

Further, we submitted the RIZE protocol to FDA which

allows us to expand the study to clinical sites in the United States.

Our second clinical asset, RZ402, is a selective

and potent plasma kallikrein inhibitor (“

PKI ”) being developed as a potential oral therapy for the chronic treatment

of diabetic macular edema (“

DME ”).

RZ402 is currently in Phase 1 development.

In January 2021, we dosed the first subject

in the Phase 1a study, and in May 2021, we announced positive topline results whereby single dose oral administration of RZ402 resulted

in plasma concentrations that substantially exceeded target pharmacologically-active drug levels, demonstrating the potential for once

daily dosing.

RZ402 was generally safe and well-tolerated at all doses tested, without dose-limiting toxicities.

In August 2021, we announced

the initiation in the Phase 1b multiple-ascending dose study and planned to be completed by the first quarter of calendar year 2022.

favorable results are also obtained in the Phase 1b study, we expect to advance developmental activities toward a Phase 2a proof-of-concept

study during the second half of calendar year 2022.

HI is an ultra-rare pediatric genetic disorder

characterized by excessive production of insulin by the pancreas.

If untreated, the elevated insulin levels in these patients can induce

extreme hypoglycemia (low blood sugar) events, increasing the risk of neurological and developmental complications, including persistent

feeding problems, learning disabilities, recurrent seizures, brain damage or even death.

There are no approved therapies for HI and the

current standard of care treatments are suboptimal.

In some cases, pancreatic surgery is a treatment option, but this approach is invasive

and may require repeat surgeries.

Our lead candidate, RZ358, is an intravenously

administered human monoclonal antibody that binds to a unique site (allosteric) on the insulin receptor throughout the body, such as in

the liver, fat, and muscle.

The antibody modifies insulin's binding and signaling to maintain glucose levels in a normal range which counteracts

the effects of elevated insulin in the body.

Therefore, we believe that RZ358 is ideally suited as a potential therapy for conditions

characterized by excessive insulin levels, and it is being developed to treat the hyperinsulinism and low blood sugar characteristic of

diseases such as HI.

As RZ358 acts downstream from the beta cells, it has the potential to be universally effective at treating HI caused

by any of the underlying genetic defects.

RZ358 received Pediatric Rare Disease Designation

as well as Orphan Drug Designation in the U.S.

and European Union.

RZ358 is currently in Phase 2b development (the RIZE study,

The RIZE study is a multi-center, open-label, repeat-dose Phase 2b study of RZ358 in four sequential dosing cohorts of patients

with HI who are at least two years old and have residual low blood sugar (<70 mg/dL) that is inadequately controlled on existing therapies.

In addition to safety and pharmacokinetic evaluations, continuous glucose monitoring (“CGM”) and self-monitored blood glucose

will be utilized to evaluate several glycemic efficacy endpoints.

The primary endpoint is the time within a glucose target range of 70-180

mg/dL by CGM after week 8 of treatment compared to baseline.

DME is a vascular complication of diabetes and

a leading cause of blindness in the U.S.

and elsewhere.

Chronic exposure to high blood sugar levels can lead to inflammation, cell damage,

and the breakdown of blood vessel walls.

Specifically, in DME, blood vessels behind the back of the eye become porous and permeable leading

to the unwanted infiltration of fluid into the macula.

This fluid leakage creates distorted vision and left untreated, blindness.

Currently available treatments for DME

involve frequent burdensome anti-vascular growth factor (anti-VEGF) injections into the eye or invasive laser surgery.

designed to be a once daily oral therapy for the treatment of DME.

Unlike the anti-VEGF therapies, RZ402 targets the

Kallikrein–Kinin System in order to address inflammation and vascular leakage.

We believe that systemic exposure through oral

delivery is critical to target the microvasculature behind the back of the eye.

Further, as an oral therapy, RZ402 has the potential

to substantially change the therapeutic paradigm for patients suffering with DME by providing a convenient, self-administered

treatment option to encourage patients to initiate therapy sooner, adhere to prescribed treatment guidelines, and improve overall

We face competition from pharmaceutical and biotechnology

companies, academic institutions, governmental agencies, and private research organizations in recruiting and retaining highly qualified

scientific personnel and consultants and in the development and acquisition of technologies.

There are a handful of companies developing therapies

for HI that are potential competitors to RZ358.

Crinetics Pharmaceuticals Inc is one such company.

There are a handful of companies developing oral

therapies for DME that are potential competitors to the PKI therapy, KalVista Pharmaceuticals

being one such company.

Our lead clinical asset, RZ358, is a potential treatment for congenital hyperinsulinism (“HI”), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas .

If untreated, the elevated insulin levels in patients suffering with congenital HI can induce extreme hypoglycemia (low blood sugar) events, increasing the risk of neurological and developmental complications, including persistent feeding problems, learning disabilities, recurrent seizures, brain damage or even death.

There are no FDA approved therapies for all forms of congenital HI and the current standard of care treatments are suboptimal.

The current treatments used by physicians include glucagon, diazoxide, somatostatin analogues and pancreatectomy.

RZ358, is an intravenously administered human monoclonal antibody that binds to a unique site (allosteric) on the insulin receptor in insulin target tissues, such as in the liver, fat, and muscle.

The antibody modifies insulin’s binding and signaling to maintain glucose levels in a normal range which counteracts the effects of elevated insulin in the body.

RZ358 shows dose dependent pharmacokinetics with a half- life greater than two weeks which has the potential for semi-monthly dosing.

Therefore, we believe that RZ358 is ideally suited as a potential therapy for conditions characterized by excessive insulin levels, and it is being developed to treat hyperinsulinism and low blood sugar.

As RZ358 acts downstream from the beta cells, it has the potential to be universally effective at treating congenital HI caused by any of the underlying genetic defects.

A summary of the completed clinical studies for RZ358 is as follows.

A Phase 1 pharmacokinetic (“PK”) study of single intravenous doses of RZ358 at 0.1 to 9 mg/kg in healthy volunteers revealed dose-dependent pharmacokinetics with a half-life of 15 days, supporting the biweekly dosing approach.

In healthy volunteers, RZ358 prevented hypoglycemia induced by insulin administration, without producing hyperglycemia.

This effect showed a PK-pharmacodynamic (dose—response) correlation, with the hypoglycemia blunting effects of RZ358 lasting for two weeks.

The clinical proof-of-concept of RZ358 in congenital HI was evaluated in a Phase 2a study in a total of 14 patients with congenital HI.

The study investigated the PK, pharmacodynamics (“PD”), safety and preliminary efficacy of RZ358.

RZ358 was well-tolerated in adult and pediatric patients with congenital HI who received single intravenous doses in the Phase 2a study and the PK results from the Phase 2a studies were consistent with those in healthy volunteers.

There was a durable normalization of blood sugar in patients with hypoglycemia, with an approximate 50% improvement and near normalization of glucose control, which was sustained for more than two weeks after dosing.

RZ358 did not increase blood sugar levels in patients with normal blood sugar levels at baseline.

In calendar year 2022 we completed the RZ358-606 Phase 2b global clinical study for RZ358 (“RIZE”).

The RIZE study was conducted in a repeat-dose fashion to evaluate the safety, pharmacokinetics, dose-exposure response relationship and to assess the glycemic efficacy across a range of continuous glucose monitoring (“CGM”) and blood glucose monitoring-based principle glycemic endpoints to inform Phase 3.

In the study, eligible patients received RZ358 in open-label fashion in one of 4, sequentially conducted dosing cohorts of up to 8 participants per cohort.

RZ358 was administered as a 30 minute intravenous infusion every other week for eight weeks.

The first three cohorts were fixed dosing levels of RZ358 and the fourth cohort was designed to explore whether there were any advantages of a fixed titration approach.

The RIZE study enrolled 23 patients and was primarily in a young pediatric population, average ~6.5 years of age, and in a diverse group of patients across gender and genetic cause of congenital HIs.

A key entry criterion was for patients to

have continued hypoglycemia despite available therapies, to be eligible for enrollment.

We observed that patients enrolled on stable background therapies had clinically significant, and in many cases, substantial residual hypoglycemia as well as some hyperglycemia (> 180 mg/dL) at baseline.

Results from the RIZE study showed that target and expected RZ358 concentrations were achieved and dose-exposure dependent responses were also observed.

RZ358 was generally safe and well-tolerated and there were no adverse drug reactions, adverse events leading to study discontinuations, or dose-limiting toxicities.

Importantly, RZ358 demonstrated a ~50% improvement in hypoglycemia across all doses and cohorts and a ~75% improvement in hypoglycemia at the 6 mg/kg and 9 mg/kg cohorts.

Time in range by CGM improved 8% across all doses, 16% at the top dose, and more significantly (>25%) in patients without baseline hyperglycemia on SOC.

In calendar year 2022, we reported positive topline results from the RIZE study which were presented at the Pediatric Endocrine Society Meeting on May 1, 2022.

We believe that the positive results from the RIZE study will be Phase 3 enabling and accordingly we have initiated interactions with regulatory authorities in the US and Europe.

Our objective is to complete the regulatory dialogue prior to the end of the first quarter of calendar year 2023, which would facilitate initiation of a Phase 3 study in the first half of calendar year 2023.

Our second clinical asset, RZ402, is an oral plasma kallikrein inhibitor (“PKI”) being developed as a potential therapy for the chronic treatment of diabetic macular edema (“DME”).

DME is a vascular complication of diabetes and a leading cause of blindness in the US and elsewhere.

Chronic exposure to high blood sugar levels can lead to inflammation, cell damage, and the breakdown of blood vessel walls.

Specifically, in DME, blood vessels behind the back of the eye become porous and permeable leading to the unwanted infiltration of fluid into the macula.

This fluid leakage creates distorted vision, and if left untreated, blindness.

Currently available treatments for DME include anti-vascular growth factor (anti-VEGF) injections into the eye or laser surgery.

RZ402 is designed to be a once daily oral therapy for the treatment of DME and unlike the anti-VEGF therapies, RZ402 targets the Kallikrein-Kinin System to address inflammation and vascular leakage.

We believe that systemic exposure through oral delivery is critical to target the microvasculature behind the back of the eye.

Further, as an oral therapy, RZ402 has the potential to substantially change the therapeutic paradigm for patients suffering with DME by providing a convenient, self-administered treatment option to encourage earlier initiation of therapy, adherence to prescribed treatment guidelines, and improved overall outcomes.

Results from our single ascending dose (“SAD”) Phase 1a Study (“RZ402-101”) were reported in May 2021.

RZ402-101 was a first-in-human single-center, randomized, double-blind, placebo-controlled SAD study in healthy adult volunteers.

The study objectives were to characterize the safety profile and pharmacokinetics of RZ402 administered as single oral doses.

The study enrolled 30 individuals in three planned sequential dose- level cohorts of 25 mg, 100 mg, and 250 mg.

Within each ten-subject dose cohort, volunteers were randomized 8:2 to receive either RZ402 oral solution or matched placebo.

After receiving single doses, participants remained in the clinic for seven days for serial PK and safety assessments, before completing two outpatient follow-up visits at study days 14 and 30.

Dose advancement proceeded following blinded reviews of safety and PK data from the preceding cohort(s).

Single doses of RZ402 resulted in dose-dependent increases in systemic exposure.

Plasma concentrations of RZ402 significantly exceeded the 3.5 ng/mL target concentration that was pharmacologically active in animal models of DME for a 24-hour period after receipt of RZ402.

Across the dose and exposure range, there were no serious adverse events, adverse drug reactions, or discontinuations due to adverse events, and no imbalance of adverse events between the treatment and placebo control groups.

Similarly, regular laboratory, hemodynamic, cardiac, and ophthalmologic safety examinations were unremarkable.

Following the success of the SAD study, we undertook a follow-on multiple ascending dose (“MAD”) study (“RZ402-102”).

Results from the MAD Study were reported in February 2022.

RZ402-102 was a single center, randomized, double-blind, placebo-controlled, in healthy adult volunteers.

The objectives of the study were to characterize the repeat dose safety profile (including maximum tolerated dose) and PK of RZ402 administered as daily oral doses for two weeks.

study was conducted in 40 volunteers in sequential ascending dose cohorts with 10 individuals per cohort.

Within each cohort, participants were randomized in an 8:2 ratio to receive either RZ402 as an oral solution or a placebo.

Participants remained in the clinic throughout the two week dosing period for serial PK and safety assessments, before completing an outpatient follow-up visit at study day 28.

Blood biomarkers of target engagement (kallikrein activity) were explored as a systemic surrogate for DME, using a precedent from studies of kallikrein inhibitors in a systemic vascular leakage syndrome (hereditary angioedema).

Dose advancement proceeded in staggered fashion every three weeks as appropriate, following blinded reviews of data from the preceding cohort(s).

The MAD study showed dose-dependent increases in systemic exposures, with repeat-dosing to steady-state resulting in the highest concentrations of RZ402 explored to date, exceeding 200 ng/mL and 50 ng/mL at peak and 24-hour trough, respectively.

Following the precedent established in hereditary angioedema, steady-state plasma kallikrein activity in human plasma was measured on Day 14 as a biomarker of RZ402 target engagement.

Daily dosing with RZ402 inhibited plasma kallikrein in a dose and concentration-dependent manner (r=0.74;

Given that the in-vivo EC90 for RZ402 in animal models of DME is ~6 ng/mL, the results at both peak and 24-hour trough substantially exceeded target concentrations based on a combination of in-vitro and in-vivo profiling.

RZ402 was generally safe and well-tolerated, including at higher doses than previously tested in the SAD study.

There were no serious adverse events, adverse drug reactions or identified risks.

We are advancing developmental activities toward a Phase 2a proof-of-concept study, which we plan to initiate during the fourth quarter of calendar year 2022.

We face competition from pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and private research organizations in recruiting and retaining highly qualified scientific personnel and consultants and in the development and acquisition of technologies.

There are other companies developing therapies for HI that are potential competitors to RZ358, including Crinetics Pharmaceuticals, Eiger Biopharmaceuticals, Hanmi Pharmaceuticals, and Zealand Pharma.

There are also companies developing therapies for DME that are potential competitors to our PKI including Curacle, KalVista, Ocuphire Pharma, Oxurion and Verseon.

Government Regulation

Regulation by governmental authorities in the

and other countries is a significant factor in the development, manufacture and marketing of pharmaceutical products.

potential products will require regulatory approval by governmental agencies prior to commercialization.

In particular, pharmaceutical

therapies are subject to rigorous preclinical testing and clinical trials and other pre-market approval requirements by the FDA and regulatory

authorities in foreign countries.

Various federal, state and foreign statutes and regulations also govern or influence the manufacturing,

safety, labeling, storage, record keeping and marketing of such products.

We are also subject to various federal, state,

and local laws, regulations and recommendations relating to safe working conditions;

Regulation by governmental authorities in the US and other countries is a significant factor in the development, manufacture and marketing of pharmaceutical products.

All of our potential products will require regulatory approval by governmental agencies prior to commercialization.

In particular, pharmaceutical therapies are subject to rigorous preclinical testing and clinical trials and other pre-market approval requirements by FDA and regulatory authorities in foreign countries.

Various federal, state and foreign statutes and regulations also govern or influence the manufacturing, safety, labeling, storage, record keeping and marketing of such products.

We are also subject to various federal, state, and local laws, regulations and recommendations relating to safe working conditions;

laboratory and manufacturing practices;

the experimental

use of animals;

and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious

disease agents, used in connection with our research, development and manufacturing.

the experimental use of animals;

and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research, development and manufacturing.

Research and Development

We incurred approximately $15.0 million and $14.5

million in research and development expenses for the fiscal years ended June 30, 2021 and 2020, respectively.

For further discussion of

activities related to our RZ358 and RZ402 product candidates, please refer to the discussion above.

For further discussion of our research

and development expenses, please refer to the discussion under the caption Results of Operations under Item 7 of this Annual Report.

We incurred approximately $32.5 million and $15.0 million in research and development expenses for the fiscal years ended June 30, 2022 and 2021, respectively.

For further discussion of activities related to our RZ358 and RZ402 product candidates, please refer to the discussion above.

For further discussion of our research and development expenses, please refer to the discussion under the caption Results of Operations under Item 7 of this Annual Report.

Human Capital Management

As of June 30, 2021, we had 26 employees, of which

19 employees were engaged in research and development, manufacturing, clinical operations and quality activities and 7 employees in general

administrative functions.

As of June 30, 2022, we had 42 full time employees, of which 31 employees were engaged in research and development, manufacturing, clinical operations and quality activities and 11 employees in administrative functions.

Of the 42 employees, all were located in the United States.

We have a number of employees who hold advanced

degrees, such as a Ph.D.

None of our employees are covered by a collective bargaining agreement, and we have experienced no work

stoppages nor are we aware of any employment circumstances that are likely to disrupt work at any

of our facilities .

As part of our measures to attract and retain personnel, we provide a number of benefits to our full-time employees,

including health insurance, life insurance, retirement plans, paid holiday and vacation time.

We believe that we maintain good relations

with our employees.

We have a number of employees who hold Ph.D.

degrees and other advanced degrees.

None of our employees are covered by a collective bargaining agreement, and we have experienced no work stoppages nor are we aware of any employment circumstances that are likely to disrupt work at any of our facilities.

As part of our measures to attract and retain personnel, we provide a number of benefits to our full-time employees, including health insurance, life insurance, retirement plans, paid holiday and vacation time.

We believe that we maintain good relations with our employees.

Diversity and Inclusion

1 unchanged sentence

We believe that a rich culture of inclusion and diversity enables us to create, develop and fully leverage the strengths of our workforce.

Human Resources, Hiring and Professional

The development, attraction and retention of employees

is critical to our success.

We work diligently to attract the best talent from a diverse range of sources in order to meet the current

and future demands of our business.

Human Resources, Hiring and Professional Development

The development, attraction and retention of employees is critical to our success.

We work diligently to attract the best talent from a diverse range of sources in order to meet the current and future demands of our business.

We leverage both formal and informal programs to identify, foster and retain top talent.

Our Code of Business Conduct and Ethics ensures

that our conduct of business is consistent with the highest standards of business ethics.

Our Code of Business Conduct and Ethics serves

as a critical tool to help employees recognize and report unethical conduct, while preserving our culture of excellence.

Business Ethics

Our Code of Business Conduct and Ethics is designed to ensure that the conduct of our business is consistent with the highest standards of business ethics.

Our Code of Business Conduct and Ethics serves as a critical tool to help employees recognize and report unethical conduct, while preserving our culture of excellence.

Our Board of Directors, management and staff are provided with training regarding our Code of Business Conduct and Ethics.

Corporate Information

We were incorporated in Delaware in 2010 and

re-incorporated in Nevada in June 2021.

We maintain an executive office located at 201 Redwood Shores Parkway, Suite 315, Redwood City,

CA 94065 and our phone number is (650) 206-4507.

We were incorporated in Delaware in 2010 and we re-incorporated in Nevada in June 2021.

We maintain an executive office located at 201 Redwood Shores Parkway, Suite 315, Redwood City, CA 94065 and our phone number is (650) 206-4507.

Our website is located at www.rezolutebio.com .

The information contained in,

or that can be accessed through, our website is not part of, and is not incorporated into this document.

We file annual, quarterly, current reports, proxy statements and other information with the Securities and Exchange Commission (“SEC”).

The SEC maintains a website that contains our public filings and other information regarding the Company, at www.sec.gov.

The information contained in, or that can be accessed through, our website is not part of, and is not incorporated into this document.

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