What changed in this filing

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Item 1. Business

2024-02-20 compared with 2023-03-09 · 138 added, 204 removed, 533 unchanged (39% of the section changed)

We are a biopharmaceutical company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.

Our pipeline of product candidates is designed with the goal to become the patient-friendly, new-era standard-of-care medicines, in the therapeutic area of oncology.

On December 5, 2022, we entered into a Collaboration and License Agreement (the “License Agreement”) with Akeso, Inc.

and its affiliates (“Akeso”) pursuant to which we are partnering with Akeso to in-license its breakthrough bispecific antibody, ivonescimab.

Ivonescimab, known as AK112 in China and Australia, and also as SMT112 in the United States, Canada, Europe, and Japan, is a novel, potential first-in-class bispecific antibody intending to combine the benefits of immunotherapy via a blockade of PD-1 with the anti-angiogenesis benefits of an anti-VEGF into a single molecule.

Ivonescimab was engineered to bring two well established oncology targeted mechanisms together.

Through the License Agreement, we obtained the rights to develop and commercialize SMT112 in the United States, Canada, Europe, and Japan (the “Licensed Territory”).

The License Agreement and transaction closed on January 17, 2023 following customary waiting periods.

The entry into the License Agreement represents a significant change in the Company’s strategy.

All prior development and marketing activities relating to ridinilazole are being terminated.

All business activities related to anti-infectives are being reviewed for partnership opportunities for potential further development.

Our future operations will be focused on the development of ivonescimab and other future activities as the Company determines.

On September 28, 2022, we determined that we would seek partners or a divestiture of ridinilazole, our lead product candidate for treating patients suffering from Clostridioides difficile infection, also known as C.

difficile infection, or CDI, as the path forward for the clinical development of the asset.

As a result of this determination, we discontinued our only active study for ridinilazole, a pediatric clinical trial evaluating ridinilazole for treating adolescent patients with CDI.

We are currently involved in activities related to closeout of ridinilazole clinical trials.

Our other product candidate, SMT-738, has been in development for combating multidrug resistant infections, specifically carbapenem-resistant Enterobacteriaceae (“CRE”) infections.

SMT-738 is the first of a novel class of precision antibiotics that has been in preclinical development and has been undergoing investigational new drug (“IND”) enabling activities.

We will continue to pursue partnerships for further development of SMT-738.

Summit Therapeutics Inc.

(“we”, “Summit” or the “Company”) is a biopharmaceutical company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.

The Company’s pipeline of product candidates is designed with the goal to become the patient-friendly, new-era standard-of-care medicines, in the therapeutic area of oncology.

The Company’s current lead development candidate is ivonescimab, a novel, potential first-in-class bispecific antibody intending to combine the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects of an anti-VEGF compound into a single molecule.

On December 5, 2022, the Company entered into a Collaboration and License Agreement (the “License Agreement”) with Akeso, Inc.

and its affiliates (“Akeso”) pursuant to which the Company has in-licensed ivonescimab.

Through the License Agreement, the Company obtained the rights to develop and commercialize ivonescimab in the United States, Canada, Europe, and Japan (the “Licensed Territory”).

The License Agreement and transaction closed in January 2023 following customary waiting periods.

The Company’s operations will be focused on the development of ivonescimab and other future activities, as the Company determines.

The Company has begun its development for ivonescimab in non-small cell lung cancer (“NSCLC”), specifically launching Phase III clinical trials in the following indications:

a) ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (“EGFR”)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (“TKI”) (“HARMONi”);

b) ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)

As of the date of these financial statements, both studies are enrolling patients.

The entry into the License Agreement with Akeso represents a significant change in the Company’s strategy and its future operations will be focused on the development of ivonescimab and other future activities as the Company determines.

The Company’s portfolio includes ridinilazole, a product candidate for treating patients suffering from Clostridioides difficile infection, also known as C.

difficile infection, or CDI.

All prior development and marketing activities related to ridinilazole have been terminated.

The Company’s anti-infectives portfolio includes SMT-738, the first of a novel class of precision antibiotics for combating multidrug resistant infections, specifically carbapenem-resistant Enterobacteriaceae (“CRE”) infections.

The Company will continue to pursue partnerships for further development of SMT-738.

Akeso Collaboration and License Agreement

Our License Agreement with Akeso, as referred to above, calls for Summit to receive the rights to develop and commercialize ivonescimab in the United States, Canada, Europe, and Japan (the “Licensed Territory”).

Akeso will retain development and commercialization rights for the rest of the regions including China.

In exchange for these rights, Summit made an upfront payment during the first quarter of 2023 comprising of $474.9 million cash and the issuance of 10 million shares of Company common stock in lieu of $25.1 million cash pursuant to the a share transfer agreement.

In connection with the License Agreement, the Company has also agreed to enter into a Supply Agreement with Akeso, pursuant to which Summit agreed to purchase a certain portion of drug substance for clinical and commercial supply (the “Supply Agreement”).

Pursuant to the License Agreement with Akeso, the Company received the rights to develop and commercialize ivonescimab in the Licensed Territory.

Akeso will retain development and commercialization rights for the rest of the world excluding the Licensed Territory.

In addition, the Company will potentially owe Akeso (a) milestone payments tied to achievement of regulatory approval of ivonescimab with various regulatory authorities in Licensed Territory (b) milestone payments tied to achievement of annual revenue from ivonescimab in Licensed Territory and (c ) Royalty payments equal to low-double-digit percentage of annual revenues from ivonescimab in Licensed Territory.

In connection with the License Agreement, the Company has also agreed to enter into a Supply Agreement with Akeso;

pursuant to the License Agreement, Summit agreed to purchase a certain portion of drug substance for clinical and commercial supply (the “Supply Agreement”).

Pursuant to the terms of the License Agreement, Summit will have final decision-making authority with respect to commercial strategy, pricing and reimbursement and other commercialization matters in the Licensed Territory.

Summit has not assumed any liabilities (including contingent liabilities), nor acquired any physical assets or trade names, or hired or acquired any employees from Akeso in connection with the License Agreement.

Ivonescimab is a novel potential first-in-class PD-1 / VEGF bispecific antibody, believed to be the most advanced in clinical development.

Ivonescimab is a novel potential first-in-class PD-1 / VEGF bispecific antibody, believed to be the most advanced in clinical development in the Licensed Territories.

Engineered with Akeso’s unique Tetrabody technology, ivonescimab, as a single molecule, blocks programmed cell death protein 1 (“PD-1”) from binding to PD-L1 and PD-L2, and blocks vascular endothelial growth factor (“VEGF”) from binding to VEGF receptors.

In view of the co-expression of VEGF and PD-1 in the tumor microenvironment, ivonescimab, may block these two pathways more effectively and enhance the antitumor activity, as compared to combination therapy.

Ivonescimab has received Breakthrough Therapy Designation status in China from the National Medical Products Administration (“NMPA”) for three indications:

a) ivonescimab combined with chemotherapy for the treatment of EGFR-mutated locally advanced or metastatic NSCLC patients who have progressed after taking an EGFR-TKI treatment

b) ivonescimab as the first-line treatment for locally advanced or metastatic NSCLC patients with positive PD-L1 expression

c) ivonescimab combined with docetaxel for the treatment of locally advanced or metastatic NSCLC patients who have progressed after taking a prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy .

Ivonescimab is currently being developed in China and Australia in multiple solid tumors and has been dosed in more than 500 patients.

Akeso is currently conducting, in China, a Phase III clinical trial in patients with NSCLC who are positive for an epidermal growth factor receptor (“EGFR”) mutation and whose disease has progressed after treatment with an EGFR tyrosine-kinase inhibitor (“TKI”).

As presented at ASCO 2022, ivonescimab treatment was associated with an overall response rate (ORR) in a Phase II study in patients with NSCLC who have failed EGFR-TKI’s of 68.4% and a median Progression-Free Survival (“mPFS”) time period of 8.2 months when combined with combination chemotherapy (pemetrexed and carboplatin).

The phase II study, which similarly had patients receiving ivonescimab plus chemotherapy as their first line therapy for metastatic disease, was considered to have demonstrated a tolerable safety profile and a low discontinuation rate for adverse events.

In a separate cohort, in the same phase II study, ivonescimab, combined with docetaxel in patients who have failed PD-(L)1 and chemotherapies, demonstrated a mPFS of 6.6 months.

Akeso is currently conducting, in China, a phase III clinical trial of ivonescimab monotherapy versus pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression.

Summit has clinical development and commercialization rights for SMT112 in its Licensed Territory (United States, Canada, Europe, and Japan).

Summit plans to design and conduct the clinical trial activities for SMT112 in its Licensed Territory, to support and submit relevant regulatory filings.

Summit is initiating development activities for ivonescimab and will do so first in NSCLC indications.

Ivonescimab is designed to potentially allow cooperative binding of the intended targets, such that the finding of PD-1 increases the binding affinity of VEGF and the binding of VEGF increases the affinity towards PD-1.

In view of the co-expression of VEGF and PD-1 in the tumor micro-environment (“TME”), ivonescimab, may block these two pathways more effectively and enhance the antitumor activity, as compared to combination therapy through what is believed to be a unique cooperative binding mechanism.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the TME as compared to normal tissue in the body.

As shown in Akeso’s in-vitro studies, ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18 fold increased binding affinity to PD-1 in the presence of VEGF in vitro , and over 4 times increased binding affinity to VEGF in the presence of PD-1 in vitro .

This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue.

The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

In addition, the two Phase III clinical trials sponsored by the Company, ivonescimab is also being developed in China and Australia by Akeso in multiple solid tumors and has been dosed in more than 1,600 patients globally.

Based on data published by Akeso with a cut-off date of October 2023, ivonescimab treatment after a median follow-up time of approximately 25.8 months, was associated with an overall response rate (ORR) in a Phase II study in patients with NSCLC who have failed EGFR-TKI’s of 68.4%, a median Progression-Free Survival (“mPFS”) time period of 8.5 months, and a median Overall Survival (“mOS”) of 22.5 months when combined with combination chemotherapy (pemetrexed and carboplatin).

The Phase II study, AK112-201, Cohort 2, was considered to have demonstrated a tolerable safety profile and a low discontinuation rate for adverse events.

In a separate group in the same Phase II study, AK112-301 (Cohort 1) for NSCLC patients with squamous histology, ivonescimab, combined with carboplatin and paclitaxel, in first-line advanced or metastatic patients demonstrated a mPFS of 11.1 months.

Median overall survival was not reached after a median follow-up period of 21.0 months.

Phase II study was considered to have demonstrated a tolerable safety profile and a low discontinuation rate for adverse events.

Summit plans to conduct its current clinical trials, as well as design and conduct additional clinical trial activities for ivonescimab in its Licensed Territory, to support and submit relevant regulatory filings.

Summit also plans to support additional study activities through its Investigator Initiated Study program.

Product Pipeline

Summit Sponsored Ivonescimab Trials:

Ivonescimab is currently being investigated in global Phase III clinical trials.

Phase I and II trials were completed by our partner Akeso.

This pipeline reflects clinical trials that have been initiated by Summit in its Licensed Territory.

HARMONi study (NCT05184712) is a multi-regional, registration-enabling clinical trial that we joined with Akeso, and for which we started initiating and activating sites in North America and Europe during 2023.

The first patient in our Licensed Territory was enrolled during the second quarter of 2023.

We plan to initiate additional sites in North America and Europe over the next few quarters.

We expect to complete enrollment during second half of 2024.

The co-primary endpoints for this study are Progression free survival (PFS) and Overall survival (OS).

We expect to combine data across all regions, including China, for assessing the results.

HARMONi-3 study (NCT05899608) is a phase III, is multi-regional, registration-enabling clinical trial for which we initiated activating sites in North Americas and China during fourth quarter of 2023.

We plan to initiate additional sites in North America, China, European countries, Japan and several other countries through early 2025.

Our plan to initiate in new countries and sites is dependent upon the timing and requirements for getting the regulatory approval of the clinical trial applications with the respective regulatory authorities and approvals from central or local independent review boards.

We may decide to modify our plans to go in certain regions or countries based on the timelines and requirements from the respective regulatory regions.

We commenced patient enrollment in the HARMONi-3 study during fourth quarter of 2023.

The primary endpoint for this study is Overall survival (OS).

In Q4 2023 we began collaborating with multiple institutions globally and opened our investigator initiated study program across several disease areas.

In addition, our partners at Akeso are sponsoring multiple, ongoing Phase II and III clinical trials in NSCLC and other cancers outside of our Licensed Territory.

We plan to review the data generated from these clinical trials as a part of our consideration for advancing our clinical development pipeline for ivonescimab in our Licensed Territory.

Status of Anti-Infectives Pipeline

Discuva Platform

In December 2017, we expanded our activities in the field of infectious diseases with the acquisition of Discuva Limited, a privately held United Kingdom-based company.

In December 2017, we acquired Discuva Limited, a privately held United Kingdom-based company.

Through this acquisition, we obtained a bacterial genetics platform and a suite of software-based technologies (collectively termed our “Discuva Platform”), which facilitate the discovery and development of new mechanism antibiotics.

Our Discuva Platform can be used to identify new bacterial targets for drug discovery, understand the mechanism of action of small molecules targeting varying types of bacteria and select the most optimal preclinical candidates, including those with the least propensity to develop bacterial resistance.

Our Discuva Platform uses pathogen specific transposons and aligns modified bacterial transposon mutagenesis with next generation sequencing and a proprietary end user interface.

Transposons are small segments of DNA that are capable of replicating and inserting copies of DNA at random sites in the same or a different chromosome.

Our pathogen specific transposons have three different activating promoters to drive bacterial gene upregulation, to cause gene disruption, or cause the downregulation of bacterial gene expression.

There is a single transposon insertion per genome.

The density of transposon insertion at the different genomic loci is determined in the whole library with insertion rates potentially being as high as every two to three base pairs.

We believe that our Discuva Platform has three principal uses:

i) Identifying Essential Genes in Bacteria.

We are able to use our Discuva Platform to identify genes within bacteria that are essential for their survival.

This allows us to identify new bacterial targets against which to develop new antibiotic drugs.

ii) Elucidating Mechanism of Action.

We are able to use our Discuva Platform to elucidate the mechanism of action of a compound to be inferred by the genes that are upregulated during experiments when in the presence of a drug.

We are able to rapidly identify the mechanism of action of a potential drug and this represents an important capability of our Discuva Platform.

We have been able to validate the ability of our Discuva Platform to elucidate mechanisms of action by testing antibiotic compounds representative of known classes whose mechanisms of action are known.

iii) Understanding Emergent Mechanisms of Resistance.

We are able to use our Discuva Platform to test a compound’s susceptibility towards known mechanisms of antibiotic resistance to allow us to select potential drug candidates with what we believe will be much better resistance profiles.

We believe the importance of understanding patients prior to the development of widespread resistance.

On January 20, 2023, we announced that, given the License Agreement that we entered into in December 2022 and the shift in Company’s focus to oncology, we will cease further investment in the Discuva platform and evaluate further options for the use of the Discuva Platform.

Based on the evaluation of further options for the use of the Discuva Platform, management concluded that this indicated the carrying amount of the acquired Discuva Platform intangible asset may not be recoverable and therefore, performed an impairment assessment to evaluate whether the fair value of the intangible asset was less than its carrying amount.

Based on this assessment, an impairment charge of $8.5 million was recognized during the year ended December 31, 2022, representing the aggregate carrying value of the intangible asset.

See Note 13 to our consolidated financial statements contained in this Annual Report on Form 10-K for further details.

Enterobacteriaceae Program

We have used our Discuva Platform to identify our DDS-04 series, a novel chemotype active against a clinically unexploited bacterial target that has the potential to treat Enterobacteriaceae infections.

The DDS-04 series act via a clinically unexploited target, LolCDE, which is involved in the transport of lipoproteins from the inner to outer membrane in Gram-negative bacteria.

The cell membrane is crucial for cell viability and the lol genes are essential in bacteria such as E.coli .

In April 2019, we reported data that showed our DDS-04 series to be rapidly bactericidal and highly potent across globally diverse Enterobacteriaceae strains, including multi-drug resistant isolates.

Importantly, our DDS-04 series has a low propensity for resistance development and displays no cross resistance with existing classes of antibiotics.

In July 2019, we reported initial, positive proof of concept data on an exemplar compound from our DDS-04 series across in vivo rodent models of sepsis, urinary tract infection, and pneumonia with further data presented in September 2019.

Our lead preclinical candidate for the Enterobacteriaceae program from the DDS-04 series is SMT026738 (formerly “DIS-0104145” and referred to as “SMT-738”).

SMT-738 is a novel small molecule inhibitor of the essential bacterial lipoprotein transport system (“LolCDE”) in Gram-negative bacteria, which displays a narrow spectrum of activity towards Enterobacteriaceae, that currently have very limited and failing treatment options due to resistance to existing antibiotic classes.

SMT-738 has demonstrated potent in vitro activity against global MDR isolates of E.

pneumoniae , including the clinically challenging NDM-carrying CRE isolates where many currently available treatment options have succumbed to clinical resistance including colistin, an antibiotic of last resort.

Most importantly, SMT-738 has also shown robust in vivo efficacy in relevant murine models of UTI, pneumonia and sepsis.

Preliminary toxicity studies have been conducted, and the data supports the continued clinical development of SMT-738.

SMT-738 has the potential to become a first in class antibiotic to treat life-threatening infections.

We retain worldwide clinical development and commercial rights to SMT-738.

We will continue to pursue partnerships for further development of SMT-738.

Other Material Agreements

The following material agreements relate to our commitments and obligations with respect to ridinilazole and SMT-738 only.

The entry into the License Agreement represents a significant change in the Company’s strategy.

All prior development and marketing activities relating to ridinilazole are being terminated and all business activities related to anti-infectives are being reviewed for partnership opportunities for potential further development.

In September 2017, we were awarded a contract from the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services, to fund, in part, the clinical and regulatory development of ridinilazole for the treatment of infections caused by C.

The awarded contract was originally worth up to $62.0 million.

In June 2019 and again in January 2020, BARDA increased the value of the contract such that it is now worth up to $72.5 million and brought the total amount of committed funding to $62.4 million.

As of December 31, 2022, based on translation of historical foreign currency amounts in the period, the Company has recognized $59.2 million of cumulative income since contract inception.

The contract provides for a cost-sharing arrangement under which BARDA funded a specified portion of estimated costs for the continued clinical and regulatory development of ridinilazole for CDI.

Under this cost sharing arrangement, we were responsible for a portion of the costs associated with each segment of work, including any costs in excess of the estimated amounts.

The remaining federal government funding is dependent on BARDA in its sole discretion exercising the final independent option work segment, upon the achievement by the Company of certain agreed-upon milestones for ridinilazole.

This option work segment was never exercised by BARDA.

The contract ran through April 2022 and was extended through December 2022 as a no cost contract, solely to close out open activities.

As a result of the Company's decision to not pursue further internal

clinical development of ridinilazole and seek partners or a divestiture related to ridinilazole as a path forward for the clinical development of the asset, the Company recorded expenses for the remaining clinical trial costs associated with the close out activities of ridinilazole and recognized the remainder of the deferred income that had been received from BARDA prior to the expenses being recognized during the third quarter of 2022.

Wellcome Trust

In October 2012, we entered into a translation award funding agreement with the Wellcome Trust Limited, as trustee of the Wellcome Trust, in order to support a Phase I and a Phase II clinical trial of ridinilazole for the treatment of CDI, for which we received $6.3 million.

The translation award funding agreement followed an initial funding agreement we and the Wellcome Trust entered into in October 2009, under which we received $3.7 million for preclinical development of CDI antibiotics.

In October 2017, we entered into a revenue sharing agreement with the Wellcome Trust.

Under the terms of the revenue sharing agreement upon commercialization of ridinilazole the Wellcome Trust is eligible to receive a share of the net revenues that we, our affiliates, licensees or third-party collaborators receive from commercial sales, and a one-time milestone payment of a specified amount if cumulative net revenues that we our affiliates, licensees or third-party collaborators receive exceed a specified amount.

In addition, if a third party commercializes ridinilazole following the first commercial sale by such third party, the Wellcome Trust is eligible to receive a one-time milestone payment of a share of the aggregate amount of any pre-commercial payments we receive from third-party licensees prior to such commercial sale and in the event of an assignment or sale of the assets or intellectual property pertaining to ridinilazole, the net proceeds we receive from such assignment or sale would be treated as net revenue under the revenue sharing agreement.

Eurofarma Laboratórios S.A.

In December 2017, we entered into an exclusive license and commercialization agreement with Eurofarma, pursuant to which we granted Eurofarma the exclusive right to commercialize ridinilazole in specified countries in South America, Central America and the Caribbean (the licensed territory).

We have retained commercialization rights in the rest of the world.

Under the terms of the license agreement, we received an upfront payment of $2.5 million and are entitled to receive additional development milestones upon the achievement of staged patient enrollment targets in the licensed territory in our Ri-CoDIFy 1 and Ri-CoDIFy 2 Phase III clinical trials for ridinilazole.

In February 2020, we achieved the first of these patient enrollment targets to trigger a milestone payment of $1.0 million.

In September 2021, we reached the second enrollment milestone and earned $1.25 million.

In addition, we are eligible to receive an additional $2.5 million in various development milestones, $2.4 million in commercial milestones and up to $18.0 million in sales milestones when cumulative net sales equal or exceed $100.0 million in the Eurofarma licensed territory.

Each subsequent achievement of an additional $100.0 million in cumulative net sales will result in Summit receiving additional milestone payments, which, when combined with anticipated product supply transfer payments from Eurofarma paid to us in connection with a commercial supply agreement to be entered into between the two parties, would provide payments estimated to range from a mid-teens to high-teens percentage of cumulative net sales in the Eurofarma licensed territory.

We estimate such product supply transfer payments from Eurofarma would range from a high single-digit to low double-digit percentage of cumulative net sales in the licensed territory.

With the closeout of ridinilazole clinical trials, at this time, we are not anticipating any future payments from Eurofarma under this agreement.

Under the license agreement, Eurofarma is responsible for all costs related to obtaining regulatory approval of ridinilazole in the licensed territory and is obligated to use commercially reasonable efforts to file applications for regulatory approval in specified countries in the licensed territory within a specified time period after we have filed an application for regulatory approval, or obtained regulatory approval, for ridinilazole in a jurisdiction where we retain commercial rights.

We retain sole responsibility for the clinical development of ridinilazole in all countries and are responsible for all costs related to obtaining regulatory approval for ridinilazole outside of the licensed territory.

University College London

On March 23, 2010, we entered into a collaborative research agreement with the School of Pharmacy, University of London which was later novated on November 28, 2011, by the School of Pharmacy to University College London.

As part of this agreement, and in consideration of their role in the development of the initial compound series from which ridinilazole was later identified, we agreed to pay the School of Pharmacy (now University College London) a low single-digit share of all revenue received by us with respect to ridinilazole, including any pre-commercial licensing revenue, up to a maximum of $1.2 million.

To date, we have paid $0.1 million under this agreement.

In May 2021, we announced the selection of a new preclinical candidate, SMT-738, which originated from the DDS-04 series.

SMT-738 has been under development to combat multi-drug resistant infections, specifically Carbapenem-resistant Enterobacteriaceae ("CRE") infections.

Simultaneously, Summit has received a sub-award from CARB-X to progress SMT-738 through preclinical development and an option to continue into Phase Ia clinical studies.

The award commits initial non-dilutive funding of up to $4.1 million for the preclinical phase, with the potential for a further $3.7 million available for the Phase Ia clinical phase upon successfully achieving key preclinical development milestones.

During the quarter ended September 30, 2022, CARB-X announced changes to its funding arrangements and terms and conditions.

As a result, the current arrangement concluded as of June 30, 2022 however, we have the ability to recognize revenue for any milestone payments related to work incurred subsequent to this date in accordance with this agreement.

Discuva Limited Acquisition

In December 2017, we entered into a share purchase agreement with the shareholders of Discuva, a private limited company organized under the laws of England and Wales pursuant to which we acquired all of the outstanding share capital of Discuva.

Discuva was a discovery-stage company with a bacterial genetics-based platform that facilitates the discovery and development of new mechanism antibiotics.

Under the terms of the share purchase agreement, we paid the Discuva shareholders a total upfront consideration comprised of (A) $6.7 million in cash , (B) $6.7 million of shares of common stock, satisfied by the issue of 586,685 of our fully-paid shares of common stock at a price per share of $11.41 and (C) an additional balancing amount in respect of the closing cash position.

In addition, the Discuva shareholders are entitled to receive contingent payments from us based on (i) the receipt of potential research and development tax credits to which Discuva may be entitled for the period from April 1, 2015, to the date of the share purchase agreement and (ii) approximately one-half of the economic benefit from any amounts received in connection with certain payments made to us under an existing collaboration agreement between Discuva and F.

Hoffman - La Roche Limited, or Roche.

We made two contingent payments to the Discuva shareholders in December 2018 and May 2019 totaling $1.0 million with respect to research and development tax credits for the period from April 2015 to December 2017 (when the acquisition occurred).

Separately, certain employees, former employees and former directors of Discuva are eligible for further payments from Discuva of up to $10.9 million based on specified development and clinical milestones related to proprietary product candidates developed under the platform.

The share purchase agreement contained customary representations and warranties that we and the selling Discuva shareholders made to each other as of specific dates.

The assertions embodied in those representations and warranties were made solely for purposes of the share purchase agreement and may be subject to important qualifications and limitations agreed to by us and the Discuva shareholders in connection with negotiating its terms.

Moreover, the representations and warranties may be subject to a contractual standard of materiality that may be different from what may be viewed as material to shareholders or may have been used for the purpose of allocating risk between us and the Discuva shareholders rather than establishing matters as facts.

For the foregoing reasons, no person should rely on such representations and warranties as statements of factual information at the time they were made or otherwise.

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products.

While we believe that our technologies, knowledge, experience, and scientific resources provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions, government agencies, and private and public research institutions.

Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

The markets for oncology pharmaceuticals, in which we compete, are characterized by significant scientific innovation, regulatory oversight and intense competition.

The key competitive factors affecting the success of our product candidates are

likely to be their efficacy, safety, convenience, price and availability of coverage and reimbursement from government and other third-party payors.

Many of our competitors may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do.

5 unchanged sentences

Our commercial opportunity could also be reduced or eliminated if the results of our clinical trials, both safety and efficacy, combined with other factors, do not lead to significant adoption of our product.

The key competitive factors affecting the success of our product candidates are likely to be their efficacy, safety, convenience, price and availability of coverage and reimbursement from government and other third-party payors.

Competition for ivonescimab (SMT112)

Ivonescimab is a novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking of VEGF into a single molecule.

Ivonescimab is the most advanced PD-1/VEGF bispecific antibody in clinical development and received Breakthrough Therapy Designation status in China for three indications:

a) ivonescimab combined with chemotherapy for the treatment of EGFR-mutated locally advanced or metastatic NSCLC patients who have progressed after taking an EGFR-TKI treatment

b) ivonescimab as the first-line treatment for locally advanced or metastatic NSCLC patients with positive PD-L1 expression

Ivonescimab is currently being investigated in Phase III clinical trials in China.

Summit is initiating development activities for SMT112 and will do so first in NSCLC indications.

Summit plans to start treating patients in clinical studies by the second quarter of 2023.

There are no known approved PD-(L)1/VEGF bispecific antibodies that are further advanced in clinical trial development or approved in the territories in which we have licensed ivonescimab.

There are also no known PD-1-based bispecific antibodies approved by the US Food and Drug Administration (“FDA”) or the European Medicines Agency (“EMA”).

Ivonescimab is currently being investigated in Phase III clinical trials in Summit’s Licensed Territory in two metastatic NSCLC indications:

b) ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)

Ivonescimab is also being investigated in multiple Phase II and Phase III clinical trials in China.

We plan to review the data generated from these clinical trials as a part of our consideration for advancing our clinical development pipeline for ivonescimab in our Licensed Territory.

There are no known approved PD-1/VEGF bispecific antibodies that are further advanced in clinical trial development or approved in the territories in which we have licensed ivonescimab.

There are also no known PD-1-based bispecific antibodies approved by the US Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”), or Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”).

Several pharmaceutical and biotechnology companies have established themselves in the market for the treatment of NSCLC, and several additional companies are developing products for the treatment of NSCLC.

Currently, the most commonly used treatments for NSCLC are several immuno-oncology drugs and chemotherapies, administered either as monotherapy or in combination with other approved therapeutics.

Currently, the most commonly used treatments for NSCLC are several immuno-oncology drugs and chemotherapies, administered either individually as monotherapy, in combination with each other, or in combination with other approved therapeutics.

NSCLC treatment regimens vary due to several factors, including genetic mutations and progression of disease.

Several medications have been approved by the FDA for these treatments, including, but not limited to pembrolizumab, atezolizumab, nivolumab and durvalumab.

In addition, several potential therapeutics are in various stages of development and clinical trials for the treatment of NSCLC, including Daiichi Sankyo with patritumab deruxtecan, Merck with pembrolizumab and Janssen Research & Development, LLC with their drugs lazertinib and amivantamab.

In addition to various chemotherapies, several immunotherapies have been approved by the FDA for these treatments, including, but not limited to pembrolizumab, atezolizumab, nivolumab, durvalumab, and ipilimumab.

There are anti-angiogenic therapies which are approved for the treatment of certain lung cancers, including bevacizumab and ramucirumab.

In addition, there are several targeted therapies that have also been approved, including, but not limited to, osimertinib, adagrasib, and alectinib.

Beyond currently approved therapies, several potential therapeutics are in various stages of development and clinical trials for the treatment of NSCLC, including late-stage candidates which have recently released Phase III clinical trial data in NSCLC in 2023, such as Daiichi Sankyo and AstraZeneca’s datopotamab deruxetecan and Johnson & Johnson’s amivantamab and lazertinib.

Finally, there are candidates in various stages of ongoing clinical trials for NSCLC, including Daiichi Sankyo and Merck with patritumab deruxtecan and AstraZeneca’s volrustomig, each currently enrolling in Phase III clinical trials.

Manufacturing

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We currently rely, and expect to continue to rely, on third parties for the manufacture of our product candidates and any products that we may develop.

In connection with the License Agreement, we have also agreed to enter into a supply agreement with Akeso, pursuant to which we agree to purchase a certain portion of drug substance for clinical and commercial supply (the “Supply Agreement”).

Akeso shall initially be solely responsible for the manufacture of our requirements of clinical and commercial drug substance for use in the Licensed Territory until such time that we are able to establish second source suppliers or are able to manufacture the drug substance independently.

We are using a different third-party supplier for clinical packaging, labeling and distribution of the finalized drug product.

We engaged a third-party manufacturer to provide clinical material of the active pharmaceutical ingredient ("API") of ridinilazole with a different supplier responsible for drug product manufacturing services that supplied the final drug product for use in the Phase III clinical program.

We used a different third-party supplier for clinical packaging, labeling and distribution of the finalized ridinilazole drug product.

We obtain the supplies of our API and drug products from these manufacturers pursuant to agreements that include specific supply timelines and volume expectations.

In connection with the License Agreement, we have also agreed to enter into the Supply Agreement with Akeso, pursuant to which we agree to purchase a certain portion of drug substance for clinical and commercial.

Until such time that we are able to establish second source suppliers or are able to manufacture the drug substance independently, Akeso shall initially be solely responsible for the manufacture of our requirements of clinical and commercial drug substance for use in the Licensed Territory.

We have engaged with third-parties to initiate transfer of relevant know-how and potentially establish them as second source supplier of ivonescimab.

We are using a different third-party supplier for clinical packaging, labeling and distribution of the clinical drug product.

Intellectual Property

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We also rely on trade secrets, know-how, continuing technological innovation and in-licensing opportunities to develop and maintain our proprietary and competitive position.

As of December 31, 2022, we owned or exclusively licensed a total of 6 U.S.

patents, 3 U.S.

patent applications, 3 European patents and 2 European patent applications, including original filings, continuations, divisional and validation applications, as well as numerous other foreign counterparts to these U.S.

and European patents and patent applications.

Our patent portfolio currently contains a total of 86 patents and patent applications.

Ivonescimab Program .

Following the completion of the License and Collaboration Agreement with Akeso, Summit has in-licensed the rights to various Akeso patent applications directed to ivonescimab in specific countries and has rights to control prosecution of such in-licensed intellectual property in these specific countries in collaboration with Akeso.

The collaboration has 1 patent issued with 14 pending and we expect that these patent applications (assuming the applications proceed to grant) will provide patent coverage for the program until 2042.

Discuva Platform Technology.

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We anticipate that our existing portfolio (assuming the applications proceed to grant) will provide patent coverage for our SMT-738 program until 2042.

In addition to the intellectual property patents and applications owned by the Company, following the completion of the License and Collaboration Agreement with Akeso, Summit has in-licensed the rights to various Akeso patent applications in the Licensed Territory and has rights to control prosecution of such in-licensed intellection property in the Licensed Territory in collaboration with Akeso.

Patent Term Extension .

Patent term extensions are available in the U.S.

and in some foreign countries to compensate a patentee for patent term lost between patent grant and obtaining marketing approval by a regulatory agency, such as the FDA, for a product that is protected by the patent.

In accordance with the patent term extension provision of the Drug Price Competition and Patent Term Restoration Act, better known as the “Hatch-Waxman Act”, an extension of time may be granted for one of Summit’s patents protecting ridinilazole, for example, which patent was granted several years before we may obtain marketing approval for the drug product.

This extension may provide up to an additional five years of patent term.

Similarly, patent extensions called supplementary protection certificates (“SPCs”) may be obtained in some foreign countries for patents granted in advance of obtaining market authorization.

SPCs may also provide up to an additional five years of patent term.

Summit will submit applications for patent term extensions in all countries where such extensions are available to extend patent protection for ridinilazole, as well as for future patents granted that are directed to Summit’s other drug programs in development.

The expiration dates referred to above are without regard to any potential patent term extension or other extension that may be available in the U.S.

or any other market.

Pediatric Exclusivity .

Pediatric exclusivity is another type of marketing exclusivity in the U.S.

that, if granted, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity, as well as any patent term that is listed in the FDA “Orange Book” for the corresponding drug product.

This six-month exclusivity may be granted if an NDA sponsor submits pediatric data that fairly respond to a written request from the FDA for such data.

does not need to show the product to be effective in the pediatric population studied;

rather if the pediatric clinical trial is deemed to fairly respond to the FDA’s request, and reports of the requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits, the additional six months exclusivity is granted.

A six-month pediatric extension of a SPC may also be obtained in some foreign countries, subject to carrying out an agreed pediatric investigation plan and compliance with other regulatory requirements of that country.

Trade Secrets .

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We also seek to preserve the integrity and confidentiality of our data, trade secrets and know-how by maintaining physical security of our premises and physical and electronic security of our information technology systems.

Summit, in working with Akeso, is in the process of selecting a name for ivonescimab, which we will pursue protection for as a trademark in Licensed Territories.

Summit, in working with Akeso, is in the process of selecting a name for ivonescimab, which we will pursue protection for as a trademark in licensed Summit countries.

In connection with the development of our product pipeline, we will seek protection for marks we currently use and future marks when appropriate.

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For more information, please see the section on “Risk Factors – Risks Related to Intellectual Property”.

Other Material Agreements

The following material agreements relate to our commitments and obligations with respect to ridinilazole and SMT-738 only.

The entry into the License Agreement represents a significant change in the Company’s strategy.

All prior development and marketing activities relating to ridinilazole have been terminated and all business activities related to anti-infectives are being reviewed for partnership opportunities for potential further development.

In September 2017, we were awarded a contract from the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services, to fund, in part, the clinical and regulatory development of ridinilazole for the treatment of infections caused by C.

The contract provides for a cost-sharing arrangement under which BARDA funded a specified portion of estimated costs for the continued clinical and regulatory development of ridinilazole for CDI.

Under this cost sharing arrangement, we were responsible for a portion of the costs associated with each segment of work, including any costs in excess of the estimated amounts.

The awarded contract, as amended in 2019 and 2020, provided for total award up to $72.5M, and total amount of committed funding to $62.4 million.

As of December 31, 2023, based on translation of historical foreign currency amounts in the period, the Company has recognized $59.2 million of cumulative income since contract inception.

As a result of the Company’s decision to not pursue further internal clinical development of ridinilazole and seek partners or a divestiture related to ridinilazole as a path forward for the clinical development of the asset, the Company recorded expenses for the remaining clinical trial costs associated with the close out activities of ridinilazole and recognized the remainder of the deferred income that had been received from BARDA prior to the expenses being recognized during the third quarter of 2022.

Wellcome Trust

In October 2017, we entered into a revenue sharing agreement with the Wellcome Trust.

Eurofarma Laboratórios S.A.

We have retained commercialization rights in the rest of the world.

Under the terms of the license agreement, we received an upfront payment of $2.5 million.

In 2020 and 2021, we achieved the first and second enrollment targets and earned $2.25 million We are also entitled to receive additional development, commercial and sales milestones and have a provision to enter into commercial supply agreement.

With the closeout of ridinilazole clinical trials, at this time, we are not anticipating any future payments from Eurofarma under this agreement.

University College London

To date, we have paid $0.1 million under this agreement.

In May 2021, we announced the selection of a new preclinical candidate, SMT-738, which originated from the DDS-04 series.

SMT-738 has been under development to combat multi-drug resistant infections, specifically Carbapenem-resistant Enterobacteriaceae (“CRE”) infections.

Simultaneously, Summit has received a sub-award from CARB-X to progress SMT-738 through preclinical development and an option to continue into Phase Ia clinical studies.

During the quarter ended September 30, 2022, CARB-X announced changes to its funding arrangements and terms and conditions.

Government Regulation

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All promotional materials for product candidates approved under accelerated regulations are subject to prior review by the FDA.

Limited Population Antibacterial Drug Pathway

With passage of the Cures Act, Congress authorized the FDA to approve an antibacterial or antifungal drug, alone or in combination with one or more other drugs, as a “limited population drug”.

To qualify for this approval pathway, the drug must be intended to treat a serious or life-threatening infection in a limited population of patients with unmet needs;

the standards for approval of drugs and biologics under the FDCA and the Public Health Service Act ("PHSA"), must be satisfied;

and the FDA must receive a written request from the sponsor to approve the drug as a limited population drug pursuant to this provision.

The FDA’s determination of safety and effectiveness for such a product must reflect the benefit-risk profile of such drug in the intended limited population, taking into account the severity, rarity, or prevalence of the infection the drug is intended to treat and the availability or lack of alternative treatment in such a limited population.

Any drug or biologic approved under this pathway must be labeled with the statement “Limited Population” in a prominent manner and adjacent to the proprietary name of the drug or biological product.

The prescribing information must also state that the drug is indicated for use in a limited and specific population of patients and copies of all promotional materials relating to the drug must be submitted to the FDA at least 30 days prior to dissemination of the materials.

If the FDA subsequently approves the drug for a broader indication, the agency may remove any post-marketing conditions, including requirements with respect to labeling and review of promotional materials applicable to the product.

Nothing in this pathway to approval of a limited population drug prevents sponsors of such products from seeking designation or approval under other provisions of the FDCA, such as accelerated approval.

The FDA’s Decision on an NDA/BLA

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The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included.

Even with submission of

this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

If the FDA approves a product, it may limit the approved indications for use for the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase IV clinical trials, be conducted to further assess the drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms, including REMS, which can materially affect the potential market and profitability of the product.

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However, FDA regulations impose rigorous restrictions on manufacturers’ communications, prohibiting the promotion of off-label uses.

It may be permissible, under very specific, narrow conditions, for a manufacturer to engage in

nonpromotional, non-misleading communication regarding off-label information, such as distributing scientific or medical journal information.

It may be permissible, under very specific, narrow conditions, for a manufacturer to engage in non-promotional, non-misleading communication regarding off-label information, such as distributing scientific or medical journal information.

If a company is found to have promoted off-label uses, it may become subject to adverse public relations and administrative and judicial enforcement by the FDA, the DOJ, or the Office of the Inspector General of the Department of Health and Human Services, as well as state authorities.

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The extent to which ongoing clinical trials will be governed by the Clinical Trials Regulation will depend on when the Clinical Trials Regulation becomes applicable and on the duration of the individual clinical trial.

If a clinical trial continues for more than three years from the day on which the Clinical Trials Regulation becomes applicable, the Clinical Trials Regulation will at that time begin to apply to the clinical trial.

If a clinical trial continues for more than three

years from the day on which the Clinical Trials Regulation becomes applicable, the Clinical Trials Regulation will at that time begin to apply to the clinical trial.

The new Clinical Trials Regulation aims to simplify and streamline the approval of clinical trials in the European Union.

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The European Commission may grant a so-called “marketing authorization under exceptional circumstances”.

Such authorization is intended for products for which the applicant can demonstrate that it is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, or in the present state of scientific knowledge, comprehensive information cannot be provided, or it would be contrary to generally accepted principles of medical ethics to collect such information.

Such authorization is intended for products for which the applicant can demonstrate that it is unable to provide comprehensive data

on the efficacy and safety under normal conditions of use, because the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, or in the present state of scientific knowledge, comprehensive information cannot be provided, or it would be contrary to generally accepted principles of medical ethics to collect such information.

Consequently, marketing authorization under exceptional circumstances may be granted subject to certain specific obligations, which may include the following:

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medicines rules expressly permit the E.U.

Member States to adopt national legislation prohibiting or restricting the sale, supply or use of any medicinal product containing, consisting of or derived from a specific type of human or animal cell,

such as embryonic stem cells.

While the products we have in development do not make use of embryonic stem cells, it is possible that the national laws in certain E.U.

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This requirement also applies when a company wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already authorized.

The Paediatric Committee of the EMA ("PDCO") may grant deferrals for some medicines, allowing a company to delay development of the medicine in children until

there is enough information to demonstrate its effectiveness and safety in adults.

The Paediatric Committee of the EMA (“PDCO”) may grant deferrals for some medicines, allowing a company to delay development of the medicine in children until there is enough information to demonstrate its effectiveness and safety in adults.

The PDCO may also grant waivers when development of a medicine in children is not needed or is not appropriate, such as for diseases that only affect the elderly population.

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These requirements include compliance with E.U.

cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients, including the manufacture of active pharmaceutical ingredients outside of the European Union with the intention to import the active pharmaceutical ingredients into the European Union;

cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients,

including the manufacture of active pharmaceutical ingredients outside of the European Union with the intention to import the active pharmaceutical ingredients into the European Union;

• The marketing and promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the European Union notably under Directive 2001/83EC, as amended, and E.U.

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Recently, many countries in the European Union have increased the amount of discounts required on pharmaceuticals and these efforts could continue as countries attempt to manage health care expenditures, especially in light of the severe fiscal and debt crises experienced by many countries in the European Union.

The downward pressure on health care costs in general, particularly prescription products, has become

The downward pressure on health care costs in general, particularly prescription products, has become intense.

As a result, increasingly high barriers are being erected to the entry of new products.

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In the United States and markets in other countries, patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs.

Significant uncertainty exists as to the coverage and reimbursement status of products approved by the FDA and other government authorities.

Significant uncertainty exists as to the coverage and reimbursement status of products approved by the FDA and other

government authorities.

Thus, even if a product candidate is approved, sales of the product will depend, in part, on the extent to which third-party payors, including government health programs in the United States such as Medicare and Medicaid, commercial health insurers and managed care organizations, provide coverage and establish adequate reimbursement levels for, the product.

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In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress.

A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs.

A Joint Select

Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs.

This includes aggregate reductions of Medicare payments to providers up to 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments, will remain in effect through 2027 unless additional Congressional action is taken.

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In 2022, we continued to strengthen the team by attracting a number of world class leaders with successful track records into the Company, all of our executive positions are now filled with proven leaders.

As of December 31, 2022, we had 76 full-time employees and 77 total employees.

As of December 31, 2023, we had 105 total employees.

Of our total workforce, approximately 72% work in research and development, and 28% work in finance, legal, information technology, general management and other administrative functions.

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Compensation and Benefits

We provide robust compensation and benefits programs to attract, motivate and retain our employees.

In addition to competitive compensation, we provide generous benefits including employer contributions to pension/401k plans, an employee stock purchase plan, insurance benefits, healthcare programs and paid vacation.

We provide competitive compensation and benefits programs to attract, motivate and retain our employees.

We regularly review our compensation practices and analyze the equity of compensation decisions for individual employees and our workforce as a whole.

In addition to competitive compensation, we provide generous benefits including employer contributions to pension/401k plans, an employee stock purchase plan, health and welfare programs and benefits, and paid vacation.

We are committed to ensuring that our total compensation packages are competitive while supporting our business plans and strategies.

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was incorporated in Delaware on July 17, 2020.

Our principal executive office is located at 2882 Sand Hill Road, Suite 106, Menlo Park, California and our phone number is (650) 460-8308.

Our principal executive office is located at 601 Brickell Key Drive, Suite 1000, Miami, Florida 33131 and our phone number is (650) 460-8308.

Our website is https://www.smmttx.com.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business