1、 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington,D.C.20549 FORM 10-K (Mark One)ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31,2022OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT
2、OF 1934 FOR THE TRANSITION PERIOD FROM TOCommission File Number:001-40047 Talis Biomedical Corporation(Exact name of Registrant as specified in its Charter)Delaware(State or other jurisdiction ofincorporation or organization)46-3122255(I.R.S.EmployerIdentification No.)3400 Bridge ParkwayRedwood City
3、,California 94065(Address of principal executive offices)(Zip Code)(650)433-3000 (Registrants telephone number,including area code)Securities registered pursuant to Section 12(b)of the Act:Title of each class TradingSymbol(s)Name of each exchange on which registeredCommon Stock,$0.0001 par value per
4、 share TLIS The Nasdaq Stock Market LLC Securities registered pursuant to Section 12(g)of the Act:NoneIndicate by check mark if the Registrant is a well-known seasoned issuer,as defined in Rule 405 of the Securities Act.YES NO Indicate by check mark if the Registrant is not required to file reports
5、pursuant to Section 13 or 15(d)of the Act.YES NO Indicate by check mark whether the Registrant:(1)has filed all reports required to be filed by Section 13 or 15(d)of the Securities Exchange Act of 1934 during the preceding 12 months(or for such shorter period that the Registrant was required to file
6、 such reports),and(2)has been subject to such filing requirements for the past 90 days.YES NO Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(232.405 of this chapter)during the prec
7、eding 12 months(or for such shorter period that the Registrant was required to submit such files).YES NO Indicate by check mark whether the Registrant is a large accelerated filer,an accelerated filer,a non-accelerated filer,smaller reporting company,or an emerging growth company.See the definitions
8、 of“large accelerated filer,”“accelerated filer,”“smaller reporting company,”and“emerging growth company”in Rule 12b-2 of the Exchange Act.Large accelerated filer Accelerated filer Non-accelerated filer Smaller reporting company Emerging growth company If an emerging growth company,indicate by check
9、 mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a)of the Exchange Act.Indicate by check mark whether the Registrant has filed a report on and attestation to its manageme
10、nts assessment of the effectiveness of its internal control over financial reporting under Section 404(b)of the Sarbanes-Oxley Act(15 U.S.C.7262(b)by the registered public accounting firm that prepared or issued its audit report.Indicate by check mark whether the Registrant is a shell company(as def
11、ined in Rule 12b-2 of the Exchange Act).YES NO If securities are registered pursuant to Section 12(b)of the Act,indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.Indicate by ch
12、eck mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrants executive officers during the relevant recovery period pursuant to 240.10D-1(b).The aggregate market value of the voting and non-votin
13、g common equity held by non-affiliates of the Registrant,based on the closing price of the Registrants common stock on The Nasdaq Stock Market on June 30,2022,was$7,342,048.The calculation of the aggregate market value of voting and non-voting common equity excludes shares held by executive officers
14、,directors and stockholders that the Registrant concluded were affiliates of the Registrant on such date.Exclusion of such shares should not be construed to indicate that any such person possesses the power,direct or indirect,to direct or cause the direction of the management or policies of the Regi
15、strant or that such person is controlled by or under common control with the Registrant.As of March 15,2023,there were 56,730,589 shares of the Registrants common stock and preferred stock outstanding,consisting of 26,866,915 shares of common stock and 29,863,674 shares of Series 1 convertible prefe
16、rred stock,which is a voting common stock equivalent,subject to certain limitations.DOCUMENTS INCORPORATED BY REFERENCEPortions of the Registrants definitive proxy statement relating to its 2023 Annual Meeting of Stockholders(the“2023 Proxy Statement”)are incorporated by reference into Part III of t
17、his Annual Report on Form 10-K.The 2023 Proxy Statement will be filed with the U.S.Securities and Exchange Commission within 120 days after the end of the fiscal year to which this Annual Report relates.Table of Contents PageSpecial Note Regarding Forward-Looking Statements1Summary of Risk Factors3
18、PART I Item 1.Business5Item 1A.Risk Factors20Item 1B.Unresolved Staff Comments71Item 2.Properties71Item 3.Legal Proceedings71Item 4.Mine Safety Disclosures72 PART II Item 5.Market for Registrants Common Equity,Related Stockholder Matters and Issuer Purchases of Equity Securities73Item 6.Reserved73It
19、em 7.Managements Discussion and Analysis of Financial Condition and Results of Operations74Item 7A.Quantitative and Qualitative Disclosures About Market Risk87Item 8.Financial Statements and Supplementary Data88Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosu
20、re114Item 9A.Controls and Procedures114Item 9B.Other Information114 Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections115 PART III Item 10.Directors,Executive Officers and Corporate Governance116Item 11.Executive Compensation116Item 12.Security Ownership of Certain Beneficia
21、l Owners and Management and Related Stockholder Matters116Item 13.Certain Relationships and Related Transactions,and Director Independence116Item 14.Principal Accountant Fees and Services116 PART IV Item 15.Exhibit and Financial Statement Schedules117Item 16.Form 10-K Summary120 Signatures121 i Spec
22、ial Note Regarding Forward-Looking StatementsThis Annual Report on Form 10-K(this Annual Report)contains forward-looking statements.The forward-looking statements are contained principally in the sections entitled“Risk Factors,”“Managements Discussion and Analysis of Financial Condition and Results
23、of Operations”and“Business.”These statements relate to future events or to our future financial performance and involve known and unknown risks,uncertainties and other factors which may cause our actual results,performance or achievements to be materially different from any future results,performanc
24、e or achievements expressed or implied by the forward-looking statements.Forward-looking statements include,but are not limited to,statements about:our expectations regarding our revenue,expenses and other operating results;the timing or outcome of any of our domestic and international regulatory su
25、bmissions;our planned regulatory clearance pathways;our efforts to successfully develop and commercialize our products and services,including our ability to successfully conduct clinical trials and studies and expand our product menu;our expectations of the reliability,accuracy and performance of ou
26、r products and services,as well as expectations of the benefits to patients,clinicians and providers of our products and services;future investments in our business,our anticipated capital expenditures and our estimates regarding our capital requirements,future revenues,expenses,reimbursement rates
27、and needs for additional financing;our ability to manufacture a regulatory cleared product at a low cost;impact from future regulatory,judicial,and legislative changes or developments in the United States and foreign countries;our ability to establish,maintain and grow our commercial capabilities an
28、d acquire customers;our expectations regarding our sales models;the costs and success of our research and development efforts,including the potential effects of inflation;our ability to increase demand for our products and services,obtain and maintain favorable coverage and reimbursement determinati
29、ons from third-party payers and expand geographically;the performance of our third-party suppliers and manufacturers;our ability to effectively grow,including our ability to retain and recruit personnel,and maintain our culture;the impact of the ongoing COVID-19 pandemic on our business,clinical tri
30、als,financial conditions,liquidity and results of operations;our ability to compete effectively with existing competitors and new market entrants;the impact on our business of economic or political events or trends;the size and growth potential of the markets for our products and services,and our ab
31、ility to serve those markets;andthe rate and degree of market acceptance of our products and services.In some cases,you can identify these statements by terms such as“anticipate,”“believe,”“could,”“estimate,”“expects,”“intend,”“may,”“plan,”“potential,”“predict,”“project,”“should,”“will,”“would”or th
32、e negative of those terms,and similar expressions that convey uncertainty of future events or outcomes.These forward-looking statements reflect our managements beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Annual Report and are subj
33、ect to risks and uncertainties.In addition,statements that“we believe”and similar statements reflect our beliefs and opinions on the relevant subject.These statements are based upon information available to us as of the date of this Annual Report,and while we believe such information forms a reasona
34、ble basis for such statements,such information may be limited or incomplete,and our 1 statements should not be read to indicate that we have conducted an exhaustive inquiry into,or review of,all potentially available relevant information.These statements are inherently uncertain and investors are ca
35、utioned not to unduly rely upon these statements.We discuss many of the risks associated with the forward-looking statements in this Annual Report in greater detail under the heading“Risk Factors.”Moreover,we operate in a very competitive and rapidly changing environment.New risks emerge from time t
36、o time.It is not possible for our management to predict all risks,nor can we assess the impact of all factors on our business or the extent to which any factor,or combination of factors,may cause actual results to differ materially from those contained in any forward-looking statements we may make.G
37、iven these uncertainties,you should not place undue reliance on these forward-looking statements.You should carefully read this Annual Report and the documents that we reference in this Annual Report and have filed as exhibits to this Annual Report completely and with the understanding that our actu
38、al future results may be materially different from what we expect.We qualify all of the forward-looking statements in this Annual Report by these cautionary statements.Except as required by law,we assume no obligation to update these forward-looking statements publicly,or to update the reasons actua
39、l results could differ materially from those anticipated in any forward-looking statements,whether as a result of new information,future events or otherwise.2 Summary of Risk Factors Below is a summary of material factors that make an investment in our common stock speculative or risky.Importantly,t
40、his summary does not address all of the risks and uncertainties that we face.Additional discussion of the risks and uncertainties summarized in this risk factor summary,as well as other risks and uncertainties that we face,can be found under“Risk Factors”in Part I,Item 1A of this Annual Report.The b
41、elow summary is qualified in its entirety by that more complete discussion of such risks and uncertainties.You should carefully consider the risks and uncertainties described under“Risk Factors”in Part I,Item 1A of this Annual Report as part of your evaluation of an investment in our common stock.We
42、 have realigned our business strategy to focusing on developing tests that decentralize testing primarily in the womens and sexual health markets,which will require pursuing marketing authorization through the FDAs standard 510(k)clearance process.We may not be able to obtain marketing authorization
43、 for these tests,which would adversely affect our business,financial condition and results of operations.We will likely need to raise additional capital to fund our existing operations,further develop our diagnostic system,commercialize products,if and when approved,and expand our operations.We have
44、 no products approved for commercial sale.We have no or limited experience in developing,marketing and commercializing diagnostic systems and tests,and we are continuing to evaluate the sales model for the Talis One system,which may make it difficult to evaluate the success of our business and to as
45、sess our future viability.We rely on a significant number of third-party manufacturers and suppliers for our instrument and cartridges,which has created and may continue to create delays due to the complexity of our manufacturing lines and supply chain,as well as exposure to manufacturing and supply
46、 limitations or interruptions and quality and quantity issues.We may be unable to validate our manufacturing for the Talis One instrument and cartridges at scale,which may impact our ability to support our research and development pipeline and future commercialization.The COVID-19 pandemic has and c
47、ould continue to materially adversely affect our business,financial condition and results of operations.If our products do not perform as expected,including due to errors,defects or reliability issues,our reputation and market acceptance of our products could be harmed,and our operating results,repu
48、tation and business will suffer.Our commercial success could be compromised if our customers do not receive coverage and adequate reimbursement for our products,if and when approved.Modifications to our products may require new 510(k)clearances,PMA approvals,or other marketing authorizations,or may
49、require us to cease marketing or recall the modified products until clearances,approvals,or other marketing authorizations are obtained.If we are not able to obtain,maintain,defend or enforce patent and other intellectual property protection for products,or if the scope of the patent and other intel
50、lectual property protection obtained is not sufficiently broad,our competitors could develop and commercialize products and technology similar or identical to ours,which could have a material adverse effect on our competitive position,business,financial conditions,results of operations,and prospects
51、.Some of our intellectual property has been discovered through government funded programs and thus may be subject to federal regulations such as“march-in”rights,certain reporting requirements and a preference for U.S.-based companies,and compliance with such regulations may limit our exclusive right
52、s and our ability to contract with non-U.S.manufacturers.We have incurred significant losses since our inception,and we anticipate that we will continue to incur losses for the foreseeable future,which could harm our future business prospects.3 If we are unable to regain compliance with the listing
53、requirements of the Nasdaq Capital Market,our common stock may be delisted from the Nasdaq Capital Market which could have a material adverse effect on our financial condition and could make it more difficult for you to sell your shares.4 Part IItem 1.Business.All references to“Talis Biomedical,”“Ta
54、lis,”“the Company,”“we,”“our,”and“us”in this Annual Report refer to Talis Biomedical Corporation.Overview Talis aims to transform diagnostic testing by developing and commercializing innovative products that are designed to enable accurate,reliable,low cost and rapid molecular testing for infectious
55、 diseases and other conditions at the point of care.While timely diagnosis of infectious diseases is critically important to enable effective treatment,testing is primarily performed in centralized laboratories,which require samples to be shipped for processing,delaying the return of results by days
56、.Point-of-care testing solves this problem by delivering the timely information necessary for clinical care.We are developing the Talis One system,a sample-to-answer,cloud-enabled molecular diagnostic system that could be deployed to a variety of testing settings in the United States and around the
57、world to diagnose infectious disease in the moment of need,at the point of care.The Talis One system comprises a compact instrument,single-use test cartridges and software supporting a central cloud database which work together.The system is designed to provide central laboratory levels of accuracy
58、and be operated by an untrained user.Corporate Information We were formed as a limited liability company under the Illinois Limited Liability Company Act in March 23,2010 under the name SlipChip LLC.In June 2013,SlipChip LLC merged with and into SlipChip Corporation,a Delaware corporation,with each
59、member of SlipChip LLC exchanging their respective membership interest for shares of common stock of SlipChip Corporation.In February 2018,we changed our corporate name to Talis Biomedical Corporation.Our principal executive offices are located at 3400 Bridge Parkway,Redwood City,California 94065,an
60、d our telephone number is(650)433-3000.Our corporate website address is http:/.This Annual Report contains references to our trademarks,including Talis,Talis One,and Sia DxTM and to trademarks belonging to other entities.Solely for convenience,trademarks and trade names referred to in this Annual Re
61、port,including logos,artwork and other visual displays,may appear without the or TM symbols,but such references are not intended to indicate,in any way,that their respective owners will not assert,to the fullest extent under applicable law,their rights thereto.We do not intend our use or display of
62、other companies trade names or trademarks to imply a relationship with,or endorsement or sponsorship of us by,any other companies.GeneralRecent surveys of womens and sexual health providers that we have conducted confirm the continued and strong interest in adoption of point-of-care systems,such as
63、the Talis One system.We believe the Talis One system is well positioned to meet this growing demand in both traditional and non-traditional care settings.Although there are several commercially available point-of-care systems,we believe that few,if any,sufficiently meet the needs of healthcare provi
64、ders to drive broad adoption of,and transition to,point-of-care testing from central lab testing for a broad range of infectious diseases.We believe that the ideal point-of-care technology for diagnosing infectious diseases would not only be highly accurate and rapid,but would also be easy to use,lo
65、w cost,cloud-compatible and enable multiplexing to detect multiple pathogens at the same time.We are developing Talis One tests to address some of the most critical infectious diseases in womens and sexual health,initially with a panel for Chlamydia trachomatis,Neisseria gonorrhoeae,and Trichomonas
66、vaginalis(CT/NG/TV),as well as a respiratory panel consisting of tests for influenza A,influenza B and COVID-19(Respiratory Panel).In order to bring the Talis One system to market as soon as possible,we are leveraging progress made to-date to direct our efforts on the pursuit of 510(k)clearances und
67、er the federal Food,Drug and Cosmetic Act(FDCA)for our highly differentiated platform and development of multiple test panels.We plan to conduct clinical trials to support clearance of the Respiratory Panel and CT/NG/TV test,as well as other sexually transmitted infections(STIs),such as herpes simpl
68、ex virus(HSV),vaginal infections including bacterial vaginosis(Vaginal Infections Panel),and urinary tract infections(UTI).We designed the Talis One system to address limitations of existing point-of-care diagnostic testing technologies for infectious diseases.Our system combines robust sample prepa
69、ration with highly optimized and rapid isothermal 5 nucleic acid amplification technology to enable rapid detection of infectious pathogens in a variety of unpurified patient sample types.We designed the Talis One system to have the following capabilities which we believe will create a competitive a
70、dvantage over other commercially available point-of-care technologies:Highly accurateThe Talis One system incorporates a shelf-stable,single-use test cartridge designed to fully integrate a nucleic acid amplification test(NAAT)with sample preparation,including nucleic acid extraction and purificatio
71、n.Sample preparation is well known to be a critical factor to achieve high sensitivity and specificity,along with low limits of detection for target pathogens,in molecular diagnostics.We believe this sample preparation step,which is performed in an automated fashion on our cartridge,has the potentia
72、l to result in higher sensitivity and specificity than point-of-care technologies that do not perform the sample preparation step.Our Talis One system reaches limits of detection as low as 500 viral particles per milliliter.We can achieve similarly high performance on the Talis One system for bacter
73、ia with limits of detection of bacterial pathogens as low as one infectious unit per milliliter(IFU/mL)in a variety of unpurified patient sample types,including nasal swab,vaginal swab,saliva and urine.Rapid turnaround timeThe Talis One system is designed to provide a positive or negative result in
74、less than 30 minutes,depending upon the test and the concentration of the pathogen in the sample.We believe this turnaround time meets target customers needs for a system fast enough to fit into their clinical practice.Ease of useWe designed the Talis One system for operation by untrained users and
75、to function in a CLIA-waived environment such as physicians offices,urgent care clinics,and decentralized care settings and hospitals.The Talis One system is designed to be a fully integrated sample-to-answer system requiring two minutes or less of hands-on time by users running the test.The intuiti
76、ve workflow of the Talis One system is also designed to facilitate the chain of custody of the sample without extensive tracking or handling by the user.Cartridge CapabilitiesThe cartridge is designed with five separate reaction chambers.There is the ability to add up to an additional nine chambers
77、for a total of 14 reaction chambers,which we believe could potentially enable a full menu of detection modes,from single organism to syndromic panel tests.The cartridge design allows for both robust sample purification and multiplexing capabilities that are both not generally offered by other point-
78、of-care diagnostic platforms.Cloud-enabledUnlike other point-of-care instruments,the Talis One system incorporates a cellular modem within the instrument,designed to connect to the cloud to help customers manage clinical data and workflow using our Sia Dx feature.Sia Dx is designed to allow(i)remote
79、 and secure access to the cloud to obtain key data required to collect,screen,collate,report and monitor disease infection and pandemic spread on a micro and macro level and(ii)remote management of instruments in the field,such as providing automated software updates and enabling customers to track
80、and manage instruments they have across their networks.For instances where cellular connectivity is unavailable or undesired,the instrument is designed to permit secure connectivity via ethernet.Sia Dx has been built into the Talis One system but will require that we submit additional data to the FD
81、A for review prior to implementation.Scalable for different throughput requirementsThe Talis One system is designed to provide a scalable system for different volume and throughput requirements.The instruments are portable and designed for multi-instrument deployments to satisfy different testing vo
82、lume requirements and can be stacked three instruments by three instruments without disturbing the cellular connection to the cloud.Low cost to manufactureWe designed the Talis One system to be low-cost and manufactured at scale.We believe this could facilitate(i)scale-up in manufacturing and provid
83、e a competitive advantage in cost-sensitive environments and(ii)customers acquiring multiple Talis One instruments to meet their volume requirements.6 Our Business Strategy Our strategy is to improve medical care through the transformation of diagnostic testing by enabling customers in distributed d
84、iagnostic locations to deploy accurate,reliable,low cost and rapid molecular testing for infectious diseases and other conditions.To achieve this,we intend to:Complete development of and,if marketing authorizations are obtained,commercialize tests for infections requested by the womens health and se
85、xually transmitted infections markets in the United StatesWe are developing tests for respiratory infections,including influenza A and influenza B.In 2022,we delivered a pre-submission to the U.S.Food and Drug Administration(FDA)for the Respiratory Panel,and we intend to pursue marketing authorizati
86、on through the 510(k)clearance pathway.The FDAs marketing authorization requirements for the Respiratory Panel will impact the timing to develop and commercialize this combination panel,if authorized.We are also developing a full menu of tests for infections related to womens health and sexually tra
87、nsmitted infections.We are focusing initially on our CT/NG/TV test,for which we plan to initiate a clinical study to support a 510(k)pre-market notification.We are subsequently targeting other STIs,such as a panel for sexually transmitted inflection that would include CT/NG/TV,a Vaginal Infection Pa
88、nel,a panel for UTI,and single target tests for infectious agents such as HSV and Group B streptococcus(Group B Strep).Increase the flexibility of our manufacturing capabilities to support the development and commercialization of the Talis One system with a clear path to meaningful margins in the fu
89、tureWe have invested in automated cartridge manufacturing lines to consistently produce cartridges that meet industry standards and our anticipated commercial needs.We have also invested in internal cartridge manufacturing lines that(i)provide us with flexibility to support our internal research and
90、 development and upcoming clinical trials,(ii)improve our understanding of the manufacturing process and(iii)help maintain our cartridge inventory.We continue to refine and improve high throughput in our manufacturing lines to ensure that we maintain our ability to manufacture at scale with acceptab
91、le cost of goods for commercialization.Pursue commercialization of our Talis One system in the United StatesWe intend to initially launch the Talis One system in the United States and will further refine our commercialization strategy as regulatory milestones are cleared.Continue to invest in capabi
92、lities to drive sustainable growthWe intend to focus on innovation to improve the technical performance of our Talis One system and develop an expanded test menu.We intend to continue our research and development activities and to leverage proprietary innovations to develop additional systems in the
93、 future designed to solve diagnostic challenges for our customers.We continue to strive for operational efficiencies and manufacturing capabilities to further drive economies of scale and lower manufacturing costs.We are restructuring our contract manufacturing partnerships and leveraging internal p
94、rocesses to enable greater flexibility and a pathway to what we believe will be industry-leading cost of goods sold.Industry background Infectious disease remains among the top health problems facing populations around the world.Mortality rate for all infectious disease in the United States ranged b
95、etween 42 and 63 deaths per 100,000 population,accounting for 5.4%of overall mortality for the period of 1980-2014.7 The drawbacks of centralized laboratory testingThe need to send samples to a central location for testing introduces delays in treatment or incentivizes prescribing treatment in the a
96、bsence of a definitive diagnosis.The turnaround time for centralized lab tests is typically one to five days and can often be longer.Therefore,physicians are faced with one of two choices:either wait days for test results before initiating treatment and risk that an infected patient may continue to
97、spread the infection and suffer increasingly negative health effects from delayed treatment or treat empirically while the patient is in front of them.Smaller hospital and clinic laboratories,many in rural settings,may not have the testing volume to justify investing in high throughput molecular dia
98、gnostic instruments,requiring smaller hospitals to send out molecular testing to reference laboratories and wait for the results.We believe that immediate access to high-quality diagnostic test results will improve medical treatment of disease and avoid inappropriate prescription of antibiotics,whic
99、h can amplify the growing problem of antibiotic resistant bacteria.In a 2016 study of 1,103 emergency room patients at St.John Hospital&Medical Center in Detroit,440 patients who had a suspected chlamydia or gonorrhea infection were treated with antibiotics even though the vast majority,323 patients
100、(74%),ultimately tested negative for the infection.Similarly,in some cases,test result delays lead to patients who do not return after the initial visit,resulting in the health care provider losing these patients to follow-up and unnecessarily exposing additional individuals to detectable and treata
101、ble infections.This is particularly problematic in pediatric care and for urgent care and community care clinics.Limitations of current point-of-care diagnostic technologiesThere are a broad range of point-of-care technologies available for use in physician offices for a variety of applications,rang
102、ing from glucose strips for diabetes to lateral flow immunoassays for detecting high pathogen load infections,such as Strep A or influenza.Molecular testing is less common in point-of-care settings,despite being highly accurate.We believe that this is due to a lack of available point-of-care molecul
103、ar technologies that sufficiently balance speed,accuracy and cost to meet customer needs and drive broad adoption.We believe that most molecular diagnostic solutions currently being marketed for use at the point-of-care each have one or more of the following limitations:Low performance as measured b
104、y sensitivity,specificity and limit of detection can result in misdiagnosis and poor clinical outcomes.Several point-of-care molecular diagnostic systems provide results in less than 30 minutes but achieve this speed by performing nucleic acid amplification on samples,foregoing sample preparation,wh
105、ich is known to limit the sensitivity,specificity and limit of detection of these nucleic acid tests.Slow turnaround time can extend beyond the time a patient will wait for results and potentially result in loss of patient to follow-up.Other available point-of-care systems may provide reliable,high
106、performance results,but these tests can take 45 to 90 minutes to return a result.While results returned within hours is better than days,we believe that the longer a test takes,the less willing patients will be to wait at the clinical site for results,thereby risking patients failing to return after
107、 the initial visit and unnecessarily exposing additional individuals to a detectable infectious agent.Systems requiring significant user interaction or monitoring will not work well with clinical workflow.Some sold as point-of-care solutions require users to transfer solutions midway through a run o
108、r handle the instrument,test cartridge and/or sample multiple times,in order to process one test.The typical physicians office does not have laboratory personnel who can monitor an instrument,nor personnel trained in sample custody tracking.Systems that are difficult to manufacture at low cost or at
109、 scale can limit adoption.We believe that the cost of purchasing and using diagnostic testing systems and consumables is a primary concern for customers.Limited test menus fail to meet the needs of clinicians.The adoption of diagnostic technologies is contingent upon the technology having both clini
110、cal utility,and economic rationale.Without a broad and relevant testing menu,testing systems may not sufficiently meet the clinical needs of customers to justify the expense.We believe the ability to develop our planned additional tests will create a competitive barrier to entry for other systems.8
111、The Talis One system We are developing the Talis One system to address the limitations of existing point-of-care diagnostic testing technologies for infectious diseases.Our system combines robust sample preparation with highly-optimized and rapid isothermal nucleic acid amplification technology to e
112、nable rapid detection of infectious pathogens in a variety of unpurified patient sample types.The Talis One system is an integrated system that includes a compact instrument,single-use test cartridges and software,including a central cloud database.Talis One cartridgeAt the core of our system is the
113、 Talis One cartridge,a versatile shelf-stable and single-use test cartridge designed to fully integrate proprietary highly-optimized nucleic acid isothermal amplification tests with sample preparation.The cartridge is designed to handle a wide range of sample types,including nasal swab,vaginal swab,
114、saliva,urine,whole blood,plasma,serum and sputum,to be compatible with chemical,enzymatic,and mechanical lysis,e.g.,by bead-beating in order to process a wide range of pathogens,including viral,bacterial and hard-to-lyse fungal pathogens.The cartridge design incorporates a patented rotary valve that
115、 integrates sample purification and is easily adaptable to alternate fluidic layouts to accommodate alternate testing methods that may require pre-treatment of specimens,pre-amplification and/or multiple purification steps to facilitate expansion of the testing menu.The cartridge also incorporates r
116、eagent plug technology,which is designed to enable implementation of new tests on the same cartridge backbone simply by inserting plugs with different target test reagents.The reagent plugs in our cartridges are optically clear,permitting the instrument to visualize and detect fluorescent signals fr
117、om the amplification test.Patented test wells employ a fluidic design and include a mechanism to heat-seal the cartridge for amplicon containment designed to prevent contamination of the work surfaces.The cartridge,with modifications,is designed to support up to 14-well multiplexing,which we believe
118、 will enable development of expanded panels and syndromic applications.The specific cartridge that we developed for the CT/NG/TV test provides 5-fold multiplexing,which we believe is sufficient to meet our near-term product plans.Talis One instrumentThe Talis One instrument is designed to enable sam
119、ple-to-answer capabilities without user intervention.We designed the instrument to be low cost,portable and easy to use.We believe the modular design,which is divided into major subsystems for performing cartridge handling,sample preparation,amplification and detection,will facilitate automated asse
120、mbly and low-cost manufacturing.The compact size,approximately 7 x 10 x 14 inches,is designed to enable portability and use in various front-line locations.The instrument incorporates a touchpad interface for easily communicating instructions,information and results to the user.An integrated camera
121、that reads and enables registration of a label on the cartridge,facilitates sample custody by linking an image of the cartridge label with test results.The instruments are designed for multi-instrument deployments to satisfy different testing volume requirements and can be stacked three instruments
122、by three instruments without disturbing the cellular connection to the cloud.Talis One software and ITThe Talis One system incorporates the Sia Dx software which enables the communication of test results to a central cloud database that can be remotely and securely accessed to obtain key data requir
123、ed to collect,screen,collate,report,and monitor disease infection and pandemic spread on a micro and macro level.The cellular and ethernet connectivity built into each Talis One instrument is also designed to enable Health Insurance Portability and Accountability Act of 1996(HIPAA)-compliant transmi
124、ssion,storage,and review.Such centralized storage could permit(i)creation of a public health interface granting access to select information to governmental entities and/or(ii)automatic transmission of notifiable diseases to public health authorities.The cloud-based data could serve to help institut
125、ions better manage clinical practice and also to improve infection control.With substantially increased adoption over time,the data may offer a mapping of infection patterns that public health and research institutions can use to address care on a larger scale.Additionally,for organizations that may
126、 desire multiple instrument placements,such as in multiple exam rooms,multiple departments or distributed testing sites,authorized administrators may be able to monitor,in real-time,the status of any instrument in the organization,as well as manage users,passwords,and certain security features.The c
127、ontinuous connectivity of the Talis One instruments is also designed to enable us to provide automated updates including security patches,instrument configurations,and 9 firmware and software updates,the latter of which could be deployed to enable the instrument to recognize and run newly released t
128、ests.Talis One workflowThe Talis One system is capable of being integrated into the clinical workflow as follows:(1)label cartridge with patient information,(2)dispense sample into loading port and close lid,(3)insert cartridge into instrument,and(4)follow on-instrument instructions to initiate test
129、ing,results will automatically display after less than 30 minutes.The workflow may vary for alternate sample types.The Talis One workflow follows a few simple steps from sample preparation to results.The system is designed to return results in less than 30 minutes and requires two minutes or less of
130、 hands-on time for the operator.After the sample is collected and the cartridge is introduced into the instrument,the instrument confirms the operability of the cartridge,runs the test and communicates the test result to the instrument display.We believe the ease of use,compact size and speed could
131、enable near-patient diagnosis in a broad range of settings.Talis One test kitsWe are a development stage company and,to date,our only source of revenue has been from the sale of the third-party COVID-19 antigen tests(Antigen Tests)which concluded at the end of 2022,and we have not generated revenue
132、from the sales of our own product.As described below,we are developing Talis One tests for infections related to womens health,STIs and respiratory infections.Our first test to be marketed will be a test for CT/NG/TV pursuant to a 510(k)pre-market notification to the FDA(if available to us;otherwise
133、 we would plan to submit another form of marketing authorization under the FDAs standard medical device authorities).We chose our test development roadmap to address the most common clinically relevant tests that require high sensitivity and specificity and for which timely results provide significa
134、nt clinical benefit.In addition to the CT/NG/TV test,our womens and sexual health roadmap includes plans to develop and seek marketing authorization for(1)a test for HSV;(2)a multitarget panel test for UTI;(3)the Vaginal Infection Panel;and(4)a single target test for Group B Strep.Infectious Disease
135、sWe are developing our Talis One system to be used for infections related to womens health,STIs and respiratory infections.We intend to complete clinical development of our Talis One system for CT/NG/TV and submit a 510(k)pre-market notification to the FDA after the successful completion of our clin
136、ical trials.We further intend to explore authorization to affix a CE Mark from the EMA soon after 510(k)clearance,if obtained.If cleared or otherwise authorized for marketing,this would be our first commercial offering in our womens health menu.We are planning to develop additional tests for infecti
137、ons related to womens health,including a panel for STIs and other infections,such as the Vaginal Infection Panel,UTI and HSV.The American Congress of Obstetricians and Gynecologists recommends annual CT/NG screening of all sexually active women age 25 and younger and for women over age 25 with risk
138、factors.In addition to promoting our test menu to our existing customers,we will engage in a focused commercialization effort directed towards obstetricians and gynecologists,where we estimate that a substantial majority of CT/NG testing occurs.Traditionally,testing is carried out by centralized lab
139、oratories,and we believe that there is a significant opportunity to move these tests to the point-of-care at the office of the obstetrician and gynecologist or in urgent care clinics or primary care facilities.We believe testing at the point-of-care could(i)improve decision making and enable the pro
140、vider to use this information to treat the patient in the same visit and(ii)improve the patient experience and empower providers and patients to adhere to screening guidelines and improve outcomes.We also believe that care providers may be able to create profit opportunities by bringing testing in-h
141、ouse to the point-of-care.We believe the tests that we are developing for our Talis One system have established reimbursement codes,enabling healthcare providers to submit for reimbursement.The Talis One COVID-19 test was the first product that we developed for respiratory infections.Although we do
142、not currently plan a broad commercial launch for the stand-alone COVID-19 test,we plan to seek marketing authorization for the Respiratory Panel through a 510(k)clearance process.10 Future applicationsWe are developing new algorithms and a bioinformatics pipeline to design rapid isothermal tests tha
143、t are based on isothermal amplification chemistries.On the Talis One system,we have observed limits of detection of bacterial pathogens as low as one IFU/mL in a variety of unpurified patient sample types,including nasal swab,vaginal swab,saliva and urine.We have also demonstrated,in a research sett
144、ing,rapid detection of similarly low concentrations for a variety of bacterial,fungal,parasitic and viral pathogens.We are investigating adding multi-color and semi-quantitative detection capabilities to the Talis One instrument to support our test product roadmap.Commercialization and Manufacturing
145、We are developing relevant in-vitro diagnostic tests for a variety of respiratory infections and infections related to womens health and STIs.We estimate that the total potential annualized addressable global market opportunity for molecular testing of infectious diseases is over$5.4 billion for 202
146、2 and is expected to grow to over$7.1 billion by 2026.We intend to initially launch in the US and will explore commercialization strategies outside of the United States in the future.We intend to offer our Talis One system to customers via direct purchase of the instrument and through reagent rental
147、.Under these options we expect to generate revenue in the form of instrument sales or rentals,test cartridge sales,instrument warranty payments,and test collection device revenue.In 2022,we discontinued further investment in commercializing our stand-alone COVID test.In conjunction with this decisio
148、n,we eliminated our sales force and reduced our commercial team supporting our product development and marketing needs.Leveraging progress we have made to-date with our stand-alone COVID test,we are conducting investigational field studies with the Talis One system to gain user experience and feedba
149、ck on the platforms physical components,workflow,and software.Results from these studies will help inform the development of our planned product roadmap.To support future commercialization of the Talis One system,we invested in automated manufacturing to provide us with the advantages of quality,spe
150、ed and cost at full scale.In 2022,we demonstrated our ability to manufacture cartridges and instruments at the quality and pace needed with a clear path to what we believe will be attractive gross margins in the future.In order to drive further efficiency and cost reduction in the manufacturing proc
151、ess,we have begun restructuring our relationships with our contract manufacturing partners.We believe we have sufficient instrument and cartridge inventory and in-house capacity to support our internal development and clinical trial needs through initial commercialization.CompetitionThe in vitro dia
152、gnostics industry is characterized by rapidly advancing technologies,intense competition and a strong emphasis on proprietary intellectual property.Due to the significant interest and growth in diagnostics,we expect ongoing intense competition primarily from centralized laboratories and diagnostic c
153、ompanies offering both point-of-care and at-home solutions.We believe key competitive factors include the accuracy,utility,turnaround time and economics of our products,and commercial execution.We also believe our ability to succeed in the future depends on the timing of obtaining regulatory clearan
154、ces and approvals,as well as the timing of our ability to deliver instruments and consumables into the marketplace in significant volumes.Our competitors include those offering molecular,antibody and antigen tests.Competitors in the reference lab category include Laboratory Corporation of America Ho
155、ldings(commonly referred to as LabCorp)and Quest Diagnostics Incorporated,along with many hospital laboratories.Our competitors in the point-of-care and/or at-home category,for molecular and/or antigen tests include Abbott Laboratories,bioMrieux SA,Cepheid(a subsidiary of Danaher Corporation),Thermo
156、 Fischer Scientific Inc.,Roche Molecular Systems,Inc.,and QuidelOrtho.Many of our current or potential competitors,either alone or with their collaboration partners,have significantly greater financial resources and expertise in research and development,manufacturing,regulatory clearance approval an
157、d compliance,and sales and distribution than we do.Smaller or early-stage companies developing tests may also prove to be significant competitors,particularly through collaborative arrangements with large and established companies or customer networks.If our competitors(i)develop and commercialize d
158、iagnostic products or services that are more accurate,more convenient to use or more cost-effective than our products or services and/or 11(ii)obtain FDA or other regulatory clearance or approval for their products more rapidly than we may obtain clearance or approval or other marketing authorizatio
159、ns for ours,our commercial opportunity could be reduced or eliminated,especially if our competitors establish a strong market position before we are able to enter a particular market.Government ContractNational Institutes of Health-Rapid Acceleration of Diagnostics(RADx)In July 2020,we were awarded
160、a$25.4 million contract from the National Institutes of Health(NIH)for Phase 2 of its RADx initiative(NIH Contract),of which$9.6 million had been received as of December 31,2022,for the validation,approval,and scale-up of capacity for manufacturing of the Talis One instrument and test cartridges.Due
161、 to delays in meeting certain milestones,we received several extensions to the NIH Contract that concomitantly extended the time to perform the remaining milestones and reduced the potential milestone payments.The NIH Contract expired on January 30,2022,and we did not achieve the final two milestone
162、s.We intend to explore additional government grants to help support our product roadmap.Operations Our products have been manufactured by several third parties.The instrument assembly is largely manual with some automation in testing.We have various suppliers that provide molded parts and reagents t
163、hat are assembled by two contract manufacturers for the cartridge.We have made significant investments to scale up cartridge manufacturing including high cavity count molding capability and automation of significant portions of the cartridge assembly process.In addition to restructuring and streamli
164、ning our contract manufacturing relationships,we have focused on developing more internal expertise in manufacturing and have developed internal pilot manufacturing lines.Our operations consist of demand forecast planning,raw material procurement,and quality oversight.The operations team is responsi
165、ble for ensuring adherence to our Quality Management System to meet or exceed applicable standards to support manufacturing,testing and distribution of our products.Supply chain managementWe utilize multiple vendors for our supply chain.Currently,many of the materials,enzymes and reagents used in ou
166、r systems and cartridges are from single source suppliers.However,we continually evaluate redundancy vendors for reagents and other materials,where possible.We believe we have sufficient inventory for the majority of our materials to support our research and development efforts and planned clinical
167、trials but will supplement our inventory,as needed.We continue to manage inventory levels,our supplier terms and other supply chain risks to help ensure an uninterrupted supply as we approach commercialization.Supply Agreement with thinXXS Microtechnology AG(thinXXS)In May 2020,we entered into a sup
168、ply agreement with thinXXS(thinXXS Agreement),a wholly-owned subsidiary of IDEX Corporation(NYSE:IEX),for the purchase of certain materials,including single-use cartridges for use with the Talis One system and components and subassemblies of such single-use cartridges.In March 2023,we entered into a
169、 termination agreement with thinXXS,pursuant to which we(i)terminated the thinXXS Agreement,(ii)received possession and title to automated manufacturing lines and certain related materials,and(iii)entered into a license agreement under which we received a patent license to thinXXS intellectual prope
170、rty that may be incorporated into the Talis One system.Intellectual propertyOur intellectual property strategy is focused on protecting our core technologies,including target-specific amplification reagents,integrated cartridges and components thereof,and related instrumentation and software applica
171、tions through patents and other intellectual property rights.In addition,we protect our ongoing research and development into the detection of infectious diseases through patents and other intellectual property rights in the United States and foreign jurisdictions,such as Japan,China,the United King
172、dom and the European Union(through 12 shared registration or examination agencies such as the European Patent Office or European Intellectual Property Office).PatentsAs of March 1,2023,we solely own 15 issued U.S.patents,17 pending U.S.patent applications,23 issued foreign patents,and 128 pending fo
173、reign patent applications.Our patent portfolio generally includes patents and patent applications relating to microfluidic systems,our rapid isothermal amplification method,integrated cartridges and instrument for the Talis One system,as well as components thereof and methods of operating the same.I
174、n addition to patents and applications related generally to the Talis One system,our portfolio includes patents and applications drawn to test reagents for specific targets,including CT and NG.Issued U.S.patents in our portfolio of company-owned and in-licensed patents and patent applications(if iss
175、ued)are expected to expire between 2035 and 2045.TrademarksOur trademark portfolio is designed to protect the brands of our current and future products and includes U.S.trademark applications for registration for our company name,Talis,and the product names,Talis One and Sia Dx.Trade secretsWe also
176、rely on trade secrets,including know-how,unpatented technology and other proprietary information,to strengthen our competitive position.We have determined that certain technologies,such as aspects of our amplification chemistry,some bioinformatics,data processing and analysis techniques,and manufact
177、uring processes are better kept as trade secrets,rather than pursuing patent protection.To prevent disclosure of trade secrets to others,it is our policy to enter into nondisclosure,invention assignment and confidentiality agreements with parties who have access to trade secrets,such as our employee
178、s,collaborators,outside scientific collaborators,consultants,advisors and other third parties.These agreements also provide that all inventions resulting from work performed for us or relating to our business and conceived or completed during the period of employment or assignment,as applicable,are
179、our exclusive property.In addition,we take other appropriate precautions,such as physical and technological security measures,to guard against misappropriation of our proprietary information by third parties.In addition to Talis-owned intellectual property,we may also in-license third party intellec
180、tual property for use in our products through both exclusive and non-exclusive licensing agreements.Although we have been able to obtain licenses on commercially reasonable terms,there is no guarantee that we may obtain such licenses in the future on reasonable terms or at all.Government regulation
181、and product approval Our products under development and our operations are subject to significant government regulation.Regulation in the United StatesIn the United States,our products are regulated as medical devices by the FDA and other federal,state,and local regulatory authorities.Numerous laws
182、and regulations govern the processes by which medical devices are brought to market and marketed,including the FDCA and the FDAs implementing regulations,among others.The FDA regulates the preclinical and clinical testing,approval,manufacture,labeling,distribution,and promotion of medical devices.Th
183、e FDA enforces these requirements by inspection and market surveillance.Failure to comply with applicable regulatory requirements may result in enforcement action by the FDA,which may include fines,injunctions,civil penalties,recall or seizure of products,total or partial suspension of production,re
184、fusing our request for 510(k)clearance or pre-market authorization(PMA)of new product versions,revocation of 510(k)clearance or PMAs previously granted,and criminal prosecution and penalties.The FDA classifies all medical devices into one of three classesClass I,Class II or Class IIIdepending on the
185、 degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness.Class I and Class II devices are subject to the FDAs General Controls,and special controls as deemed necessary by the FDA to ensure the safety and e
186、ffectiveness of Class II devices,including performance standards,post-market surveillance,clinical investigations,patient registries and additional conditions set forth in FDA guidance documents.While most Class I devices are exempt from the 510(k)pre-market notification requirement,manufacturers of
187、 most Class II devices are required to submit to the FDA a pre-market notification under Section 510(k)of the FDCA requesting permission to commercially distribute the device.The FDAs permission to commercially distribute a device subject to a 510(k)pre-market notification is generally known 13 as a
188、 510(k)clearance.Devices deemed by the FDA to pose the greatest risks are placed in Class III,requiring approval of a PMA application.At this time,we have no Class III devices in the pipeline nor plans to add Class IIIs.In addition,EUAs and other forms of approval or clearance may be limited for use
189、 with tests by authorized laboratories certified under CLIA to perform moderate and high-complexity tests.In order for a test to be used at the point-of-care,the FDA must grant the test waived status under CLIA,which would permit any laboratory with a Certificate of Waiver to perform the test.The U.
190、S.Secretary of the Department of Health and Human Services(HHS)may declare public health emergencies that have a significant potential to affect national security or the health and security of U.S.citizens.On February 4,2020,the novel coronavirus was declared a public health emergency,and it was dec
191、lared that circumstances existed justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus that causes COVID-19.These EUAs will terminate upon declaration that the public health emergency circumstances have ceased,or the product pro
192、vided pursuant to EUA has otherwise achieved commercial authorization for the emergency indication for use,such as through 510(k)clearance,de novo process,or PMA approval.In order to be the subject of an EUA,the FDA Commissioner(under authority delegated by the Secretary of the HHS)must conclude tha
193、t,based on the totality of scientific evidence available,it is reasonable to believe that the product may be effective in diagnosing,treating,or preventing a disease attributable to the agents described above,that its known and potential benefits outweigh its known and potential risks,and that there
194、 is no adequate,approved and available alternative.The FDA may revise or revoke an EUA to protect the public health.510(k)clearance processTo obtain 510(k)clearance,we must submit a pre-market notification to the FDA demonstrating that the proposed device is substantially equivalent to a previously-
195、cleared 510(k)device,a pre-amendment device that was in commercial distribution before May 28,1976 for which the FDA has not yet called for the submission of a 510(k)or PMA applications,or is a device that has been reclassified from Class III to either Class II or I.In rare cases,Class III devices m
196、ay be cleared through the 510(k)process.The FDAs 510(k)clearance process usually takes from three to twelve months from the date the application is submitted and filed with the FDA but may take significantly longer.Although many 510(k)pre-market notifications are cleared without clinical data,in som
197、e cases,the FDA requires significant clinical data to support substantial equivalence.In reviewing a pre-market notification submission,the FDA may request additional information,including clinical data,which may significantly prolong the review process.If the FDA agrees that the device is substanti
198、ally equivalent to a predicate device currently on the market,it will grant 510(k)clearance to commercially market the device.If the FDA determines that the device is not substantially equivalent to a previously cleared device,the device is automatically designated as a Class III device.The device s
199、ponsor must then fulfill more rigorous PMA requirements,or can request a risk-based classification determination for the device in accordance with the de novo classification process,which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalen
200、t to a predicate device.Once a de novo application is reviewed and approved,it results in the device having a Class II status and future devices from the company or a competitor may use the companys de novo-classified device as a 510(k)predicate.After a device receives 510(k)clearance,any subsequent
201、 modification of the device that could significantly affect its safety or effectiveness,or that would constitute a major change in its intended use,will require a new 510(k)clearance or could require a PMA.The FDA requires each manufacturer to make this determination initially,but the FDA may review
202、 any such decision and may disagree with a manufacturers determination.If the FDA disagrees with a manufacturers determination,the FDA may require the manufacturer to cease marketing and/or recall the modified device until 510(k)clearance or approval of a PMA is obtained.Under these circumstances,th
203、e FDA may also subject a manufacturer to significant regulatory fines or other penalties.Over the last several years,the FDA has proposed reforms to its 510(k)clearance process,and such proposals could include increased requirements for clinical data and a longer review period,or could make it more
204、difficult for manufacturers to utilize the 510(k)clearance process for their products.For example,in November 2018,FDA officials announced forthcoming steps that the FDA intends to take to modernize the pre-market notification pathway under Section 510(k)of the FDCA.Among other things,the FDA announ
205、ced that it planned to develop proposals to drive manufacturers utilizing the 510(k)pathway toward the use of newer predicates.These proposals included plans to potentially sunset certain older devices that were used as predicates under the 510(k)clearance 14 pathway,and to potentially publish a lis
206、t of devices that have been cleared on the basis of demonstrated substantial equivalence to predicate devices that are more than 10 years old.The FDA also announced that it intends to finalize guidance to establish a pre-market review pathway for“manufacturers of certain well-understood device types
207、”as an alternative to the 510(k)clearance pathway and that such pre-market review pathway would allow manufacturers to rely on objective safety and performance criteria recognized by the FDA to demonstrate substantial equivalence,obviating the need for manufacturers to compare the safety and perform
208、ance of their medical devices to specific predicate devices in the clearance process.In May 2019,the FDA solicited public feedback on its plans to develop proposals to drive manufacturers utilizing the 510(k)pathway toward the use of newer predicates,including whether the FDA should publish a list o
209、f devices that have been cleared on the basis of demonstrated substantial equivalence to predicate devices that are more than 10 years old.These proposals have not yet been finalized or adopted,and the FDA may work with Congress to implement such proposals through legislation.More recently,in Septem
210、ber 2019,the FDA finalized the aforementioned guidance to describe an optional“safety and performance based”pre-market review pathway for manufacturers of“certain,well-understood device types”to demonstrate substantial equivalence under the 510(k)clearance pathway,by demonstrating that such device m
211、eets objective safety and performance criteria established by the FDA,obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process.Pervasive and continuing FDA regulationAfter a medical device is placed on
212、the market,numerous FDA regulatory requirements apply,including,but not limited to the following:the Quality System Regulation(QSR),which requires manufacturers to follow design,testing,control,documentation and other quality assurance procedures during the manufacturing process;establishment regist
213、ration,which requires establishments involved in the production and distribution of medical devices,intended for commercial distribution in the United States,to register with the FDA;medical device listing,which requires manufacturers to list the devices they have in commercial distribution with the
214、 FDA;clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices;medical device reporting regulations,which require that a manufacturer report to
215、 the FDA if a device it markets may have caused or contributed to a death or serious injury,or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury,if the malfunction were to recur;correction,removal and advisory not
216、ification reporting regulations,which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;complying with the new federal law
217、and regulations requiring Unique Device Identifiers(UDI)on devices and also requiring the submission of certain information about each device to the FDAs Global Unique Device Identification Database;the FDAs recall authority,whereby the agency can order device manufacturers to recall from the market
218、 a product that is in violation of governing laws and regulations;labeling regulations,which prohibit“misbranded”devices from entering the market,as well as prohibit the promotion of products for unapproved or“off-label”uses and impose other restrictions on labeling;andpost-market surveillance inclu
219、ding the clinical performance of the product after introduction into the market and Medical Device Reporting,which requires manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury,or malfunctioned in a way that would likely cause or contribute to a
220、 death or serious injury if it were to recur.15 The FDA enforces these requirements by inspection and market surveillance.Failure to comply with applicable regulatory requirements may result in enforcement action by the FDA,which may include one or more of the following sanctions:warning letters;cus
221、tomer notifications for repair,replacement or refunds;fines,injunctions,consent decrees and civil penalties;mandatory recall or seizure of our products;administrative detention or banning of our products;operating restrictions,partial suspension or total shutdown of production;refusing our request f
222、or 510(k)clearance or PMA of new product versions;revocation of 510(k)clearance or PMAs previously granted;andcriminal prosecution and penalties.International RegulationSales of medical devices outside the United States are subject to foreign government regulations and international standards compli
223、ance,which vary substantially from country to country.In order to market our products in other countries,we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries.The time required to obtain approval by a foreign country may be longer or shorter
224、than that required for FDA clearance or approval,and the requirements may differ significantly.Other healthcare laws Our current and future business activities are subject to healthcare regulation and enforcement by the federal government and the states and foreign governments in which we conduct ou
225、r business.These laws include,without limitation,state and federal anti-kickback,fraud and abuse,false claims,physician sunshine transparency,and healthy information privacy and security laws and regulations.The federal Anti-Kickback Statute(AKS)prohibits,among other things,any person or entity from
226、 knowingly and willfully offering,soliciting,receiving or providing remuneration,directly or indirectly,overtly or covertly,in cash or in kind,to induce either the referral of an individual,for an item or service or the purchasing,leasing,ordering,or arranging for or recommending the purchase,lease
227、or order of any good,facility,item or service,for which payment may be made,in whole or in part,under federal healthcare programs such as the Medicare and Medicaid programs.The term remuneration has been interpreted broadly to include anything of value.Although there are a number of statutory except
228、ions and regulatory safe harbors protecting some common activities from prosecution,the exceptions and safe harbors are drawn narrowly.Practices that involve remuneration that may be alleged to be intended to induce prescribing,purchases or recommendations may be subject to scrutiny if they do not q
229、ualify for an exception or safe harbor.Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the AKS.Instead,the legality of the arrangement will be evaluated on a case-by-case basis based on a
230、cumulative review of all its facts and circumstances.Several courts have interpreted the statutes intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business,the AKS has been violated.In addition,a person o
231、r entity does not need to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation.The federal civil and criminal false claims laws,such as the civil False Claims Act(FCA),prohibit individuals or entities from,among other things,knowingly presenti
232、ng,or causing to be presented,false,fictitious or fraudulent claims for payment or approval by the federal government,and knowingly making,using or causing to be made or used a false record or statement material to a false or fraudulent claim,or knowingly making a false statement to improperly avoid
233、,decrease or conceal an obligation to pay money to the federal government.Additionally,the FCA authorizes actions to be brought on behalf of the federal government by a private party having knowledge of the alleged fraud.Because the complaint is initially filed under seal,the action may be pending f
234、or some time before the 16 defendant is even aware of the action.If the government intervenes and is ultimately successful in obtaining redress in the matter,or if the plaintiff succeeds in obtaining redress without the governments involvement,then the plaintiff will receive a percentage of the reco
235、very.The federal government is using the FCA,and the accompanying threat of significant liability,in its investigation and prosecution of life sciences companies throughout the country,for example,in connection with the promotion of products for unapproved uses and other sales and marketing practice
236、s.In addition,the government may assert that a claim including items or services resulting from a violation of the federal AKS constitutes a false or fraudulent claim for purposes of the civil FCA.The government has obtained multi-million and multi-billion dollar settlements under the FCA in additio
237、n to individual criminal convictions under applicable criminal statutes.Given the significant size of actual and potential settlements,it isexpected that the government will continue to devote substantial resources to investigating healthcare providers and manufacturers compliance with applicable fr
238、aud and abuse laws.The civil monetary penalties statute imposes penalties against any person or entity that,among other things,is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not pro
239、vided as claimed or is false or fraudulent.The majority of states also have anti-kickback laws which establish similar prohibitions and,in some cases,may apply to items or services reimbursed by any third-party payor,including commercial insurers.HIPAA created new federal criminal statutes that proh
240、ibit,among other actions,knowingly and willfully executing,or attempting to execute,a scheme to defraud any healthcare benefit program,including private third-party payors,and knowingly and willfully falsifying,concealing or covering up a material fact or making any materially false,fictitious or fr
241、audulent statement in connection with the delivery of or payment for healthcare benefits,items or services.Like the AKS,a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.Moreover,the federal Physician Pa
242、yments Sunshine Act requires certain manufacturers of drugs,devices,biologics and medical supplies for which payment is available under Medicare,Medicaid or the Childrens Health Insurance Program,with specific exceptions,to report annually to the Centers for Medicare&Medicaid Services(CMS),informati
243、on related to payments or other transfers of value made to physicians(defined to include doctors,dentists,optometrists,podiatrists and chiropractors),certain other healthcare professionals(such as physician assistants and nurse practitioners),and teaching hospitals,and applicable manufacturers and a
244、pplicable group purchasing organizations to report annually to CMS ownership and investment interests held by such physicians and their immediate family members.The Physician Payments Sunshine Act includes in its reporting requirements a broad range of transfers of value including,but not limited to
245、,consulting fees,speaker honoraria,charitable contributions,research payments and grants.Failure to report could subject companies to significant financial penalties.Tracking and reporting the required payments and transfers of value may result in considerable expense and additional resources.Severa
246、l states currently have similar laws and more states may enact similar legislation,some of which may be broader in scope.For example,certain states require the implementation of compliance programs,compliance with industry ethics codes,implementation of gift bans and spending limits,and/or reporting
247、 of gifts,compensation and other remuneration to healthcare professionals.The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to comply with different compliance and/or reporting requirements in multiple jurisdictions increase the possibili
248、ty that a healthcare company may violate one or more of the requirements.If our future operations are found to be in violation of any of such laws or any other governmental regulations that apply to us,we may be subject to significant penalties,including,without limitation,administrative,civil and c
249、riminal penalties,damages,fines,disgorgement,imprisonment,the curtailment or restructuring of our operations,additional reporting and oversight requirements,exclusion from participation in federal and state healthcare programs and imprisonment.Coverage and reimbursementSales of our products will dep
250、end in large part on the availability of adequate coverage and reimbursement from third-party payors,including government programs such as Medicare and Medicaid,private insurance plans and managed care programs.These third-party payors are increasingly limiting coverage and reducing reimbursement fo
251、r medical products and services.In addition,the U.S.government,state legislatures and foreign governments have continued implementing cost-containment programs,including price controls and restrictions on coverage and reimbursement.Adoption of price controls and cost-containment measures,and adoptio
252、n of more restrictive policies in jurisdictions with existing controls and measures,could further limit our net revenue and results.17 Hospitals,clinical laboratories and other healthcare provider customers that may purchase our product candidates,if approved,generally bill various third-party payor
253、s to cover all or a portion of the costs and fees associated with diagnostic tests,including the cost of the purchase of our product candidates.If our product candidates are cleared or approved by the FDA as point-of-care tests and deemed CLIA-waived following market authorization,we expect that the
254、 majority of our diagnostic tests will be performed in physician offices and other point-of-care settings and billed using existing Current Procedural Terminology(CPT)codes.Our healthcare provider customers may not purchase our tests unless third-party payors cover and provide adequate reimbursement
255、 for a substantial portion of the price of the tests.If we are not able to obtain coverage and an acceptable level of reimbursement for our tests from third-party payors,there would typically be a greater co-insurance or co-payment requirement from the patient for whom the test is ordered or the pat
256、ient may be forced to pay the entire cost of the test out-of-pocket,which could dissuade practitioners from ordering our tests and,if ordered,could result in a delay in or decreased likelihood of collecting payment,whether from patients or from third-party payors.Our customers access to adequate cov
257、erage and reimbursement for our products and/or product candidates by government and private insurance plans is central to the acceptance of our products.We may be unable to sell our products on a profitable basis if third-party payors deny coverage or reduce their current levels of payment,or if ou
258、r costs of production increase faster than increases in reimbursement levels.The potential end-users of our Talis One system and diagnostic tests include large elder care chains where vulnerable residents have unmet needs for millions of high sensitivity tests per year;urgent care chains that serve
259、on the front lines of COVID-19 diagnosis,needing millions of rapid tests to triage symptomatic patients;and traditional medical establishments including hospitals,ambulatory surgery centers,cancer treatment and dialysis centers,independent practice associations,accountable care organizations,and pub
260、lic health clinics that need rapid and high-quality testing to best serve their patients.Hospitals,physicians and other healthcare providers who purchase diagnostic products in the United States generally rely on third-party payors,such as private health insurance plans,Medicare and Medicaid,to reim
261、burse all or part of the cost of the product.Therefore,our market success is highly dependent upon government and commercial third-party payors providing coverage and adequate reimbursement for our test.While we believe our COVID-19 test will qualify for coverage that is currently available for othe
262、r COVID-19 tests on the market,coverage criteria and reimbursement rates for diagnostic tests are subject to adjustment by payors,and current reimbursement rates could be reduced,or coverage criteria restricted in the future,which could adversely affect the market for our tests.There has been federa
263、l and state legislation and other reform initiatives regarding the coverage and reimbursement for COVID-19 diagnostic testing in response to the COVID-19 outbreak.For example,the Families First Coronavirus Response Act(FFCRA)generally requires group health plans and health insurance issuers offering
264、 group or individual health insurance to cover FDA approved COVID-19 tests and associated diagnostic costs with no cost-sharing,as long as the test is deemed medically appropriate and furnished on or after March 18,2020 and during the applicable public health emergency period.The FFCRA also permits
265、states to cover testing for the uninsured through Medicaid with federal financing.Additionally,the Coronavirus Aid,Relief,and Economic Security Act expanded the FFCRA to include a broader range of diagnostic tests and services as well as requiring plans and issuers to cover out-of-network COVID-19 t
266、est claims at up to the cash price that the provider has posted on a public website.CMS announced plans in March 2020 to cover the cost of COVID-19 diagnostic testing under the Medicare program and identified the amount at which it would reimburse for such tests,which has been adjusted numerous time
267、s.For example,Medicare adjusted its payment methodology effective January 1,2021,such that it will pay$100 per test only to those laboratories that complete high throughput COVID-19 diagnostic tests within two calendar days of the specimen being collected and will only pay$75 per test to laboratorie
268、s that take longer than two days to complete such test.This change is indicative of the evolving nature of the coverage and reimbursement of COVID-19 tests.In addition,there has been federal and state legislation and other reform initiatives regarding the coverage and reimbursement for COVID-19 diag
269、nostic testing in response to the COVID-19 outbreak which continue to evolve.For example,effective January 15,2022,private health insurance companies and group health plans are required to cover eight free over-the-counter at-home COVID-19 diagnostic tests authorized,cleared,or approved by the FDA p
270、er covered individual per month.18 Data Privacy In the ordinary course of our business,we may process personal data and,accordingly,we are,or may become,subject to numerous data privacy and security obligations,including federal,state,local,and foreign laws,regulations,guidance,and industry standard
271、s related to data privacy,security,and protection.Such obligations may include,without limitation,the Federal Trade Commission Act,the Health Insurance Portability and Accountability Act of 1996(HIPAA),the California Privacy Rights Act of California(CRPA),the European Unions General Data Protection
272、Regulation 2016/679(EU GDPR),the EU GDPR as it forms part of United Kingdom(UK)law by virtue of section 3 of the European Union(Withdrawal)Act 2018(UK GDPR),and the ePrivacy Directive.In addition,several states within the United States have enacted or proposed data privacy laws,including Virginia,Co
273、lorado,Utah and Connecticut.The CRPA,EU GDPR,and UK GDPR are examples of the increasingly stringent and evolving regulatory frameworks related to personal data processing may increase our compliance obligations and exposure for any noncompliance.For example,the CPRA,effective January 1,2023,gives,am
274、ong other things,California residents the ability to limit use of certain sensitive personal data,establishes restrictions on personal data retention,expands the types of data breaches that are subject to a consumer private right of action,and establishes a new California Privacy Protection Agency t
275、o implement and enforce the new law.In addition,U.S.federal and state consumer protection laws may require us to publish statements that accurately and fairly describe how we handle personal data and choices individuals may have about the way we handle their personal data.European data privacy and s
276、ecurity laws(including the EU GDPR and UK GDPR)impose significant and complex compliance obligations on entities that are subject to those laws.For example,the EU GDPR applies to any company established in the European Economic Area(EEA)and to companies established outside the EEA that process perso
277、nal data in connection with the offering of goods or services to data subjects in the EEA or the monitoring of the behavior of data subjects in the EEA.These obligations may include limiting personal data processing to only what is necessary for specified,explicit,and legitimate purposes;requiring a
278、 legal basis for personal data processing;requiring the appointment of a data protection officer in certain circumstances;increasing transparency obligations to data subjects;requiring data protection impact assessments in certain circumstances;limiting the collection and retention of personal data;
279、increasing rights for data subjects;formalizing a heightened and codified standard of data subject consents;requiring the implementation and maintenance of technical and organizational safeguards for personal data;mandating notice of certain personal data breaches to the relevant supervisory authori
280、ty(ies)and affected individuals;and mandating the appointment of representatives in the UK and/or the EU in certain circumstances.See the section titled“Risk Factors Risks related to regulatory matters”for additional information about the laws and regulations to which we are or may become subject an
281、d about the risks to our business associated with such laws and regulations.Human capital resourcesAs of December 31,2022,we had a total of 102 full-time employees.Our employees are located in Redwood City,California,Chicago,Illinois and other locations within the United States.None of our employees
282、 are represented by any collective bargaining agreements.We believe that we maintain good relations with our employees.Our human capital resources objectives include,as applicable,identifying,recruiting,retaining,incentivizing and integrating our existing and additional employees.The principal purpo
283、ses of our equity incentive plans are to attract,retain and motivate selected employees,consultants and directors through the granting of stock-based compensation awards and cash-based performance bonus awards.Available InformationOur Annual Report on Form 10-K,Quarterly Reports on Form 10-Q,Current
284、 Reports on Form 8-K,and amendments to reports filed pursuant to Sections 13(a)and 15(d)of the Securities Exchange Act of 1934,as amended(Exchange Act),are filed with the SEC.Such reports and other information filed by us with the SEC are available free of charge on our website at http:/ when such r
285、eports are available on the SECs website.The SEC maintains an internet site that contains reports,proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov.The information contained on the websites referenced in this Annual Report o
286、n Form 10-K is not incorporated by reference into this filing.Further,our references to website URLs are intended to be inactive textual references only.19 Item 1A.Risk Factors.Careful consideration should be given to the following risk factors,together with the other information contained in this A
287、nnual Report,including our financial statements and the related notes.If any of the following risks occur,our business,financial condition,results of operations and future growth prospects could be materially and adversely affected.In these circumstances,the market price of our common stock could de
288、cline,and you may lose all or part of your investment.This Annual Report also contains forward-looking statements that involve risks and uncertainties.Our actual results could differ materially from those anticipated in the forward-looking statements as a result of a number of factors,including the
289、risks described below.See“Special note regarding forward-looking statements.”Risks related to our business and strategy We have realigned our business strategy to focusing on developing tests that decentralize testing primarily in the womens and sexual health markets,which will require pursuing mark
290、eting authorization through the FDAs standard 510(k)clearance process.We may not be able to obtain marketing authorization for these tests,which would adversely affect our business,financial condition and results of operations.We have focused our efforts on the development of the Talis One system fo
291、r FDA clearance or other marketing authorization as a point-of-care testing system for infectious diseases.Prior to the COVID-19 pandemic,we focused our research and development efforts on developing the Talis One point-of-care system for use in womens health and STI tests,including CT/NG/TV.However
292、,during the COVID-19 pandemic,we developed and received an EUA for the stand-alone Talis One COVID-19 test.Following our revocation request,the EUA was revoked by the FDA in August 2022.We have focused our resources on our multiplex products primarily in the womens and sexual health markets,initiall
293、y on a CT/NG/TV test on the Talis One system.In order to gain user experience and feedback on the Talis One systems physical components,workflow and software,we have resumed IUO system evaluations of the Talis One system.We intend to submit 510(k)submissions to the FDA for our future test menu.We ma
294、y not receive clearance or if we receive clearance,there are numerous factors to consider that make it difficult to evaluate our future business prospects and,therefore,we may not be able to achieve our goals and strategy.Failure to achieve marketing authorization for these tests would adversely aff
295、ect our business,financial conditions and resultof operations.Development of the data necessary to obtain marketing authorization of a diagnostic test is time-consuming and carries with it the risk of not yielding the desired results.The performance achieved in initial studies may not be repeated in
296、 later studies that may be required to obtain marketing authorizations.In addition,limited results from earlier-stage verification studies may not predict results from studies conducted to obtain marketing authorization.Unfavorable results from ongoing preclinical and clinical studies could result i
297、n delays,modifications or abandonment of ongoing analytical or future clinical studies,or abandonment of a product development program,or may delay,limit or prevent regulatory approvals or clearances or commercialization of our products,any of which may materially adversely affect our business,finan
298、cial condition and results of operations.Furthermore,results that would be sufficient for regulatory approval or clearance may not demonstrate strong performance characteristics,limiting the market demand for the system,which would adversely affect our business.See“Risks related to regulatory matter
299、s.We have no experience with the entire commercialization process for the Talis One system.We have gained some experience with the initial stages of the process,including demand generation,evaluations,and quoting,and we have recent commercialization experience selling and distributing the Antigen Te
300、sts as an authorized distributor.As a result,we have limited experience forecasting future financial performance for our products,including any third-party products that we may offer,such as the Antigen Tests,and our actual results may fall below our financial guidance or other projections,or the ex
301、pectations of analysts or investors,which could cause the price of our common stock to decline.In addition,we are continuing to evaluate the appropriate acquisition model for our Talis One system and cannot predict the proportion of customers that would procure the Talis One instrument through capit
302、al purchase versus our planned equipment leasing model.Our results of operations could fluctuate with high variability depending on the changes in the proportion of our customers who directly purchase as compared to renting the equipment which will make it challenging to predict our operating result
303、s,particularly during the early stages of any future commercial launch following marketing approval.Future commercialization of the Talis One system in the United States will require pursuing 510(k)clearance or another available approval path.The launch of new products is inherently uncertain and re
304、quires the completion of 20 commercialization activities that are complex,costly,time-intensive and uncertain,and require us to accurately anticipate patients,providers and,if applicable,payors attitudes and needs,the future competitive landscape,and emerging technology and industry trends.This proc
305、ess is conducted in various stages,and each stage presents the risk that we will not achieve our goals on a timely basis,or at all.Our commercial success depends,in part,on the acceptance of our diagnostic tests and services as being safe,accurate,and relatively simple for medical personnel to learn
306、 and use,clinically flexible,operationally versatile and,with respect to providers and payors,cost effective.We cannot predict how quickly,if at all,payors,providers,clinics and patients will accept future diagnostic tests and services or,if accepted,how frequently they will be used.These constituen
307、ts must believe that our diagnostic tests offer benefits over other available alternatives.The degree of market acceptance of our current and future diagnostic tests and services depends on a number of factors,including:whether our customers are willing to incur the upfront costs associated with pur
308、chasing Talis One instruments;whether there is adequate utilization of our tests by clinicians,health systems and other target groups based on the potential and perceived advantages of our diagnostic tests over those of our competitors;the convenience and ease of use of our diagnostic tests relative
309、 to those currently on the market or when our tests are launched;the effectiveness of our sales and marketing efforts;our ability to provide incremental data that show the clinical benefits and cost effectiveness,and operational benefits,of our diagnostic tests;the coverage and reimbursement accepta
310、nce of our products and services;pricing pressure,including from group purchasing organizations(GPOs),seeking to obtain discounts on our diagnostic tests based on the collective bargaining power of the GPO members;negative publicity regarding our or our competitors diagnostic tests resulting from de
311、fects or errors;the performance of our tests relative to those of our competitors;product labeling or product insert requirements by the FDA or other regulatory authorities;andlimitations or warnings contained in the labeling cleared or approved by the FDA or other authorities.Additionally,even if o
312、ur diagnostic tests achieve widespread market acceptance,they may not maintain that market acceptance over time if competing diagnostic tests or technologies,which are more cost effective or are received more favorably,are introduced.Failure to achieve or maintain market acceptance and/or market sha
313、re would limit our ability to generate revenue and would have a material adverse effect on our business,financial condition and results of operations.We may experience research and development,regulatory,marketing and other difficulties that could delay or prevent our introduction of enhanced or new
314、 products and result in increased costs and the diversion of managements attention and resources from other business matters.For example,any molecular diagnostic tests that we may develop or further enhance may not prove to be clinically effective,or may not meet our desired target product profile o
315、r be offered at acceptable cost and with the sensitivity,specificity and other test performance metrics necessary to address the relevant clinical need or commercial opportunity;our molecular diagnostic test performance in commercial settings may be inconsistent with our validation or other clinical
316、 data;we may not be successful in achieving market awareness and demand,whether through our own sales and marketing operations or entering into collaborative arrangements;the collaborative arrangements we enter into may not be successful or we may not be able to maintain those that are successful;he
317、althcare providers may not use any tests that we may enhance or develop;or we may otherwise have to abandon a product,service ore development program in which we have invested substantial resources.An important factor in our ability to commercialize our products is collecting data that supports the
318、value proposition of our products,and in particular that our tests are just as accurate and reliable as central lab testing.The data collected from any studies we complete may not be favorable or consistent with our existing data or may not be 21 statistically significant or compelling to the medica
319、l community or to third-party payors seeking such data for purposes of determining coverage for our products.Any of the foregoing could have a negative impact on our ability to commercialize our future products,which could have a material adverse effect on our business,financial condition and result
320、s of operations.We rely on a significant number of third-party manufacturers and suppliers for our instrument and cartridges,which has created and may continue to create delays due to the complexity of our manufacturing lines and supply chain,as well as exposure to manufacturing and supply limitatio
321、ns or interruptions and quality and quantity issues.We do not have any commercial-scale manufacturing facilities.We rely,and expect to continue to rely,on third parties for the manufacture of the Talis One system and our tests,as well as for commercial supply for any approved products,if ever.The ma
322、nufacturing of our Talis One instrument and cartridge is a complex process that involves over 500 raw materials,intermediates and subassemblies.The complexity of the instrument and cartridge designs and number of parts involved has presented manufacturing challenges for us and our third-party manufa
323、cturers.In addition,our reliance on these third-party manufacturers exposes us to significant risk that we will not have sufficient quantities of our products at an acceptable cost or quality,which has and could delay,prevent or impair our commercialization efforts when we commercialize.We are also
324、susceptible to increased costs of good associated with rising inflation rates.While we do not have any commercial-scale manufacturing facilities,we have invested in the development of multiple automated assembly lines for production of the test cartridges.Prior to commercialization,we will need to v
325、alidate the lines which could cause us to incur substantial expenditures or delays in order to achieve acceptable quality,costs and output.In addition,delays that may occur with one supplier could have a ripple effect with other suppliers.Such ripple effects could increase costs or obligate us to pu
326、rchase materials before they are required for commercial purposes which could increase costs,increase risk of scrap or damage relationships with our suppliers.Such delays or required expenditures could further delay the launch of our Talis One system,which would adversely impact our business,financi
327、al condition and results of operations.As we have not yet completed process validation of our high-volume assembly lines with a cleared womens health or STI test,in accordance with FDA recommendations,it may be difficult to predict the cost of manufacturing our cartridges at scale.We are undertaking
328、 a number of initiatives designed to reduce the cost of manufacturing our instruments and diagnostic tests,including reducing the costs of supplies and restructuring our contract manufacturer relationships.However,there is no guarantee that we will be able to achieve planned cost reductions from suc
329、h initiatives.For example,yield from the automated lines may be low resulting in many components to be scrapped or quality of final products may not meet our requirements,which may increase scrap and therefore,our costs.There have been unforeseen occurrences that have increased our costs for supplie
330、s used in manufacturing our cartridges and instruments,and there could be other unforeseen occurrences,such as increased prices of the components of our diagnostic tests,changes to labor costs or less favorable terms with third-party suppliers or contract manufacturing partners,including as a result
331、 of increased shipping costs caused by the substantial increase in fuel prices.As a result,even if our automated lines perform as anticipated,we may be unable to manufacture our products in a profitable manner.Almost all the materials,enzymes and reagents used in or with our instrument and cartridge
332、s are obtained from single source suppliers,which exposes us to significant supplier risk.In addition,we may purchase supplies through purchase orders and may not have long-term supply agreements with,or guaranteed commitments from,many of our suppliers,including single source suppliers.A loss of su
333、fficient supply of such components could require us to expend significant time and resources to develop or license replacement technology and obtain additional marketing authorizations.While we are evaluating redundancy vendors for reagents and other materials there can be no assurance that we will successfully contract for such materials.Our third-party manufacturers may experience manufacturing
0731-84720580
sgpjbg002
工作日 9:30 - 18:00
研報
新質生產力
DeepSeek?
低空經濟
大模型
AI Agent
AI Infra
具身智能
自動駕駛
寵物
銀發經濟
人形機器人
企業出海
算力
微短劇
薪酬
白皮書
創新藥
人工智能
AI產業
信息科技
互聯網
消費經濟
汽車交通
電商零售
傳媒娛樂
醫藥健康
投資金融
能源環境
地產建筑
傳統產業
英文報告
其它
最新報告
中英對照
全文搜索
報告精選
PDF上傳翻譯
多格式文檔互轉
入駐&報告售賣
會員權益
機構報告
券商研報
財報庫
專題合集
英文報告
數據圖表
會議報告
其他資源
行業聚焦
芯片產業
熱點概念
全球咨詢智庫
人工智能
500強
新質生產力
會議峰會
新能源汽車
企業年報
互聯網
公司研究
行業綜觀
消費教育
科技通信
醫藥健康
人力資源
投資金融
汽車產業
物流地產
電子商務
傳統產業
傳媒營銷
其它
2025低空經濟/低空產業報告合集（共49套打包）
2025年智算中心/AIDC/AI數據中心研究報告合集（共37套打包）
AI、科技與通信
廣告、傳媒與營銷
消費、零售與支付
HR、文化與旅游
金融、保險與投資
能源、環境與工業
醫療制藥與大健康
物流、地產與建筑
其他行業
AI ? 科技 ? 通信
數字化
金融財經
智能制造
電商傳媒
地產建筑
醫療醫學
能源化工
其他行業
收藏
下載
2025-05-20
AI查數
行業數據
政策法規
商業模式
產業鏈
競爭格局
市場規模
產業概述
其它
2025年
AI讀財報
年報
一季報
半年報
三季報
IPO招股書
社會責任報告
A股
IPO申報
港股
美股&全球
新三板
掃碼登錄
手機快捷登錄
賬號登錄
