UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): September 12, 2022
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
(Address of principal executive offices and zip code)
(203 ) 208-4111
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Common Stock, par value $0.001 per share | ||||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check 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. ☐
Item 7.01. Regulation FD Disclosure.
On September 12, 2022 at 4:50 p.m. Eastern Time, the Company is participating in a fireside chat at the Morgan Stanley Global Healthcare Conference in New York, New York. In connection with such presentation, the Company is posting an investor slide deck to its website at www.isoplexis.com, a copy of which is furnished herewith as Exhibit 99.1.
The information furnished in this Item 7.01, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
Exhibit No. | Description | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ISOPLEXIS CORPORATION | ||||||||||||||
| Date: September 12, 2022 | ||||||||||||||
| By: | /s/ John Strahley | |||||||||||||
| Name: | John Strahley | |||||||||||||
| Title: | Chief Financial Officer | |||||||||||||
September 2022 EMPOWERING LABS, CHANGING HUMAN HEALTH
Disclaimer and Forward-Looking Statements Forward-looking statements and other information This presentation contains “forward-looking statements.” These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on IsoPlexis’ current beliefs, expectations an d assumptions regarding the future of its business, future plans and strategies and other future conditions. Such forward-looking statements may include, without limitation, statements about future opportunities for IsoPlexis and its products and services, its future operations, financial or operating results, including its financial guidance, anticipated business levels, future earnings, planned activities, anticipated growth, market opportun ities, strategies, competitions and other expectations and targets for future periods. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “estimate,” “expe ct,” “intend,” “may,” “predict,” “project,” “target,” “potential,” “seek,” “will,” “would,” “could,” “continuing,” “forward,” “should,” “continue,” “contemplate,” “plan,” and other words and terms of similar meaning. Forward -looking statements are subject to known and unknown risks and uncertainties, many of which may be beyond its control. IsoPlexis cautions you that forward-looking statements are not guarantees of future performance or outcomes and that actual performance and outcomes may differ materially from those made in or suggested by the forward-looking statements contained in this press release. In addition, even if its results of operations, financial condition and cash flows, and the development of the markets in which IsoPlexis operates, are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in subsequent periods. New factors emerge from time to time that may cause IsoPlexis’ business not to develop as it expects, and it is not possible for it to predict a ll of them. Factors that could cause actual results and outcomes to differ from those reflected in forward -looking statements include, among others, the following: estimates of IsoPlexis’ addressable market, market growth, future revenue, expenses, capital requirements and IsoPlexis’ needs for additional financing; the implementation of IsoPlexis’ busin ess model and strategic plans for its products and technologies; competitive companies and technologies and IsoPlexis’ industry; IsoPlexis’ ability to manage and grow its business by expanding its sales to existing c ustomers or introducing its products to new customers; IsoPlexis’s ability to develop and commercialize new products; IsoPlexis’ ability to establish and maintain intellectual property protection for its products or avoid or defend claims of infringement; the performance of third party suppliers; IsoPlexis’ ability to hire and retain key personnel and to manage its future growth effectively; IsoPlexis’s ability to obtain additional financing in future offerings; the volatility of the trading price of its common stock; IsoPlexi s’ expectations regarding use of proceeds from its initial public offering (“IPO”); the potential effects of government regulati on; the impact of COVID-19 on IsoPlexis’ business; and IsoPlexis’ expectations about market trends. For a further discussion of these and other factors that could impact IsoPlexis’ future results, performance or trans actions, see the section “Risk Factors” included in its Form 10 -K filed with the Securities and Exchange Commission (“SEC”) on March 30, 2022, and its other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. It is not possible for IsoPlexis to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combinat ion of factors, may cause actual results to differ materially from those contained in any forward - looking statements it may make. IsoPlexis qualifies all of the forward-looking statements in this presentation by these cautionary statements. Except as required by law, IsoPlexis undert akes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Market, Industry and Other Data This presentation includes estimates regarding market and industry data. Unless otherwise indicated, information concerning o ur industry and the markets in which we operate, including our general expectations, market position, market opportunity and market size, are based on our management’s knowledge and experience in the markets in which we operate, together with currently available information obtained from various sources, including publicly available information, industry reports and publications, surveys, our customers, trade and business organ izations and other contacts in the markets in which we operate. Certain information is based on management estimates, which have been derived from third-party sources, as well as data from our internal research. In presenting this information, we have made certain assumptions that we believe to be reasonable based on such data and other similar sources and on our knowledge of, and our experience to date in, the markets in which we operate. Market and industry data, which is derived in part from management’s estimates and beliefs, are subject to change and may be limited by the availability of raw data, the voluntary nature of the data gathering process and other limitations inherent in any statistical survey of such data. In addition, projections, assumptions and estimates of the future performance of the markets in which we operate and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, including those described in “Risk Factors” and “Special Note Regarding Forward -Looking Statements” of the registration statement. These and other factors could cause results to differ materially from those expressed in the estimates made by third parties and by us. Trademarks Each trademark, trade name or service mark of any other company appearing or incorporated by reference in this presentation b elongs to its holder. We do not intend our use or display of other companies’ trademarks, trade names or service marks to imply a relationship with, or endorsement or sponsorship of us by, such other companies. 2
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Our Differentiated Lab Tools are Empowering the Field 4 100% OF TOP 15 PHARMA 2 78% OF COMPREHENSIVE CANCER CENTERS 3 112 PUBLICATIONS 254 INSTRUMENTS IN THE FIELD $18.7M TTM REVENUE 1 • Differentiated, High Need Product Positioning: Cell behavior & proteome workflow • Easy to Access package: Small, benchtop instruments with effortless workflow / software • Consumable Driven: Expanding installed base increasingly positions for “razorblade” model 1 Unaudited results for Q2 ending 6/30/2022. 2 By 2020 revenue. 3 Based on the National Cancer Institute’s list of Comprehensive Cancer Centers 18 inches 28 inches Leading customer base in Pharma, Biotech, Medical Centers
Key Growth Initiatives Driving IsoPlexis 5 Cellular Behavior Proteomic Multiomics Effortless Proteomics + • Commercial Growth: Drive continued velocity of 254 instrument base & flexibility of applications, demonstrating ability to ‘land and expand’ with installed base, increasing ‘razorblade’ consumable percentage of revenue • Product Growth: Enhance flexibility of IsoCode cell analysis & launch Codeplex product suite to appeal to two larger mainstream markets, with attractive differentiation vs. market leaders • Operations & Finance: Expand consumables gross margin to 70%+ range, driving top-line impact & profitability. Continue company-wide OpEx efficiencies to conserve cash while driving path to more profitable growth Proliferate Instruments, Drive “Razorblade” consumables 18 inches
Evolving One Benchtop Platform into 3 Mass Market Opportunities Coverage of Majority Cell Types Flexible Cytometry: All proteins 2022 20232021 Phospho- proteomics across cells Each Advancement increases addressable market by 2-5x 18 inches Early Access + Data Effortless Proteomics: Cytokines Early Access + Data Effortless Proteomics: All Proteins Cytometry in Throughput 2024 Targeted Transcript +All Proteins 6 IsoCode™ Single-Cell Analysis CodePlex™ Bulk Proteomics Duomic™ Multi- omics
Unique ISO Products are Increasingly Positioned for Mass Market Users 7 CodePlex Bulk Proteomics Unique Effortless Workflow, Throughput, Cost vs. Multiplexed Proteomics • Launching workflow automates 90% labor, 80% less sample, 25% less cost • Fulfilling demand of proteomics users to eliminate workflow $1.5B / $10.0B1 Unique Dimension of Cell Behavior vs. Flow Cytometry • Increasing Cell Types, Proteins Accessible, & Cell Surface flexibility • Increasing demand of flow users for function + cytometry IsoCode Single-Cell Analysis $2.5B / $12.0B1 Duomic Multi- omics Uniquely ELISA Protein (Gold Standard) vs. Standard Multi-Omics • First to launch gold standard, non-NGS proteomic data + gene expression • Fulfilling demand for greater proteomics insights to multi-omics $750M / $12.0B1
IsoCode: Highly Differentiated Cell Behavior Analysis vs. Flow Cytometry 8 Cytokines / Output Proteins per Cell Few New Dimension of Cell Behavior Surface Marker per Cell Many Adding ISO Flexibility for flow users Ease of Cytokine Workflow ✓ Ease of Use of Instrument & Software Miniaturized System (<18 inches) ✓ Instrument Requires No Technician ✓ Informatics Requires No Technician ✓
Ease of End to End Cell Analysis Workflow is Key 9 RANGE OF CELL TYPES & PROTEIN PANELS LAB’S NEED REAGENTS UNIQUE TO OUR SYSTEM: FLOW CELLS EFFORTLESSLY AUTOMATED, SMALL FOOTPRINT ANALYTICS THAT DON’T REQUIRE TECHNICIANS IsoCode™ Chip IsoLight™ & IsoSpark™ IsoSpeak™ 1 See IsoPlexis website for annotated definition of evolving functional cell library IsoLight™ & IsoSpark™ Entire Cell Library Available 1
Cell flexibility on system has expanded significantly, expanding market Extracellular Matrix / Cardio/vascular 10 Cells of the Central Nervous System Broader Immune lineages Tumor Cells of all types Vascular /Transplant Biology COVID & Infectious Disease Tumor Cell Profiling Cell Matrix / Cells BROADER PUBLICATION AREAS IN LTMBROAD COVERAGE ON ISOPLEXIS SYSTEMS* * Protocols/Publications at isoplexis.com Multiple early factors anticipate post- acute COVID-19 sequelae
30+ Cytokines, Chemokines, Growth Factors (‘20) 15+ Phosphoproteins, Translation, Transcription Factors (‘21) 15+ Integrated Phosphoproteins & Cytokines (‘22) Increasing Cell Analysis Flexibility for Comprehensive Cellular Biology 11 3 Lasers: Today Adding Cytometry Flexibility Adding Key Multiplexed Proteins Inaccessible on Flow 405nm 473nm 638nm 2 established surface markers, stains within kit (‘21) Use cases / protocols / kits with wide range of cell types (‘22) Multiple surface markers; more open flexibility with cell stains (‘23) Capability of 7 colors + brightfield on IsoSpark today 7 Colors + Brightfield Capabilities: Today
CodePlex™: Effortless Proteomics Made for This Moment 121 Multiplexed bead based ELISA workflow; 2 Consulting research; 3 * Current and future targeted panel sizes, starting with Panels around 20 plex range 5 - 503 Proteins Per Sample* 17,0002 System TAM 15+ Steps1 → 1 Step Effortlessly Automated Workflow Fully Featured Product for Access in Q1 2023 Save of Labor Cost When Compared to Traditional Methods: Save of Sample Save Price Per Sample
CodePlex Addresses Customer Pain Points vs. Status Quo 13 CHANGING WORKFORCE demanding more time away from the bench, ie. effortless workflows RESULTS DRIVEN all labs need confidence to move forward, with gold standard proteomics PRECIOUS SAMPLES samples, whether fresh or banked, are valuable & harder to access COSTS MATTER Performance must be balanced with price & labor cost ✓ ✓ ✓ ✓
Bulk Multiplexed Proteomics: Codeplex & the Workflow Opportunity 14 Traditional Bead-Based Methods Laborious and difficult workflow • Flexible analytes • Customer familiarity • Tedious workflow • Performance affected by workflow • High sample volume • High sensitivity • Very high multiplex capabilities • Requires significant expertise • Takes days to get data, with difficult workflow CodePlex Proteomics • High Multiplexing capabilities • With effortless workflow Small, easy to use, reliable, cost-effective + - + - NGS-Derivative Proteomics Applies to technical labs, high technical hurdles
Traditional vs. Codeplex Bulk Proteomic Workflow 15 Codeplex
Over 75% of Proteomics Customers Choose Mid-Plex, Codeplex’ Specialty 16 Proteomics Survey: Approximately how many cytokines or other protein markers do you feel you need to measure to create an accurate profile of cellular function? 1-5 14% 6-10 31% 11-15 17% 16-20 19% 21-25 9% 26-30 5% 31-40 1% 41-100 4% Mid-plex = Largest Part of Market: Codeplex fulfills need uniquely in this highlighted area * 302-person survey / consulting research
It’s Bulk Multiplexed Proteome Analysis Without the Bulky Process 17 Prepare Reagents 1 pipette action per sample triplicate Load Instrument Fully Automated Effortless Workflow CodePlex Platform Traditional Method Prepare Reagents 12-18 hr Incubate 20 min Wash x3 20 min Export data ? Add samples to each well 20 min Incubate 20 min Wash 20 min Add antibody 20 min Incubate 20 min Wash 20 min Add reagent 20 min Incubate 20 min Wash 20 min Incubate 20 min Manual Analysis with 3rd party software ? 24+ Hours Hands-On Time <30 Minutes Hands-On Time • Raw data • Basic statistics • Bar chart • Heat map • Dot plot 15 min 10 min 5 min Fully Automated
What does CodePlex Deliver? • 20 sample chambers per chip (80 per run) at launch • 30 sample chambers per chip (120 per run) in later ‘23 • 5 – 50 plex Assays • <10uL sample per chamber • < 30 min hands on time for assay set up • </= 15% CVs (within a single chip and across chips) • Built-in triplicate for each sample chamber • Integrated Analysis Software • Test menu value: Same instrument as IsoCode Chips 18
Phosphoproteins Cytokines, Chemokines, Growth Factors Duomic: IsoPlexis Will Drive Leadership in Proteomic Driven Multiomics 19 Proteomic Driven Multi-omics in Single Cell Biology will drive Pre-Clinical and Translational Medicine: Late 2023 as Service IsoPlexis is the only company to provide functional protein analyte classes critical to the clinical arena 1 > Data presented at SITC, AACR, & AGBT Precision Health + 1Consulting research PROTEIN DRIVEN MULTIOMICS
Full Workflow for Duomic, Powered by Proteome + Transcriptome 20 cDNA IsoZipCode™: mRNA Capture Proteomic Barcode: Protein Capture Bead w/ Unique Cellular Identifier + IsoZipCode Illustrative Schematic of Duomic workflow Single-Cell Proteome from Chamber 250 Chamber #250 Transcriptome Proteome
Duomic Will Open Up New, Clinically Relevant Multiomic Markets 21 Nature Method of the Year: Single-Cell Multimodal omicsNature Method of the Year: Single-Cell Gene expression Duomic’s novel proteomic analytes enable large, new multiomic opportunities in medicine 2013 2019
167 Foundational Patents Issued and Filed Underpins Continued Expansion 22 IsoSpark IsoSpeak CodePlex Secretome CodePlex Metabolome CodePlex Intracellular Proteome Single-Cell Secretome Single-Cell Intracellular Proteome Single-Cell Metabolome Single-Cell Sequencing & Protein IsoLight 167 PROTEOMICS, SEQUENCING, AND SYSTEM PATENTS In Situ Sequencing and Reagents Cellular Behavior Proteomic Multiomics Effortless Proteomics +
23 To cell behavior and proteomics being accessible to every lab – driving proteomic driven health Cellular Behavior Proteomic Multiomics Effortless Proteomics + Empowering Labs to Leverage Cellular & Proteomic Biology to Advance Health Going from a world where access to the right cells and proteome take highly technical labs with laborious workflows +
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