8-K
Quantum-Si Inc (QSI)
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): March 8, 2022
QUANTUM-SI INCORPORATED
(Exact name of registrant as specified in its charter)
| Delaware | 001-39486 | 85-1388175 |
|---|---|---|
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer<br><br> <br>Identification No.) |
| 530 Old Whitfield Street<br><br> <br>Guilford, Connecticut<br><br> <br>(Address of principal executive offices) | 06437<br><br> <br>(Zip Code) | |
| --- | --- |
Registrant’s telephone number, including area code: (203) 458-7100
N/A
(Former name or former address, if changed since last report)
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:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which<br><br> <br>registered |
|---|---|---|
| Class A common stock, par value $0.0001 per share | QSI | The Nasdaq Stock Market LLC |
| Redeemable warrants, each whole warrant exercisable for one share of Class A common stock, each at an exercise price of $11.50 per share | QSIAW | The Nasdaq Stock Market LLC |
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. |
|---|
From time to time, Quantum-Si Incorporated (the “Company”) presents and/or distributes slides and presentations to the investment community to provide updates and summaries of its business. On March 8, 2022, the Company gave a presentation at the 42^nd^ Annual Cowen Health Care Conference. The presentation slides and a replay of the webcast is available on the “Investors” section of the Company’s website at https://ir.quantum-si.com. This presentation is also furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 is being furnished
and 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 registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit<br><br> <br>No. | Description |
|---|---|
| 99.1 | Corporate Presentation of Quantum-Si Incorporated dated March 8, 2022. |
| 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.
| QUANTUM-SI INCORPORATED | ||
|---|---|---|
| By: | /s/ Claudia Drayton | |
| Name: | Claudia Drayton | |
| Title: | Chief Financial Officer | |
| Date: March 8, 2022 |
Exhibit 99.1
Quantum-Si Investor Update March 8 2022
Disclaimer This presentation includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. The actual results of the Company may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company's expectations with respect to future performance and development and commercialization of products and services. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. Most of these factors are outside the Company's control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the impact of COVID-19 on the Company's business; the inability to maintain the listing of the Company's Class A common stock on The Nasdaq Stock Market; the ability to recognize the anticipated benefits of the recently completed business combination, which may be affected by, among other things, competition and the ability of the Company to grow and manage growth profitably and retain its key employees; our ongoing leadership transition; changes in applicable laws or regulations; the ability of the Company to raise financing in the future; the success, cost and timing of the Company's product development and commercialization activities; the potential attributes and benefits of the Company's products and services; the Company's ability to obtain and maintain regulatory approval for its products, and any related restrictions and limitations of any approved product; the Company's ability to identify, in-license or acquire additional technology; the Company's ability to maintain its existing lease, license, manufacture and supply agreements; the Company's ability to compete with other companies currently marketing or engaged in the development or commercialization of products and services that the Company is developing; the size and growth potential of the markets for the Company's future products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company's products and services following anticipated commercial launch; the Company's estimates regarding future expenses, future revenue, capital requirements and needs for additional financing; the Company's financial performance; and other risks and uncertainties discussed in the “Risk Factors” section of the Company’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC), and risks described in other filings the Company may make with the SEC in the future. The Company cautions that the foregoing list of factors is not exclusive. The Company cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.
“I start each company to improve the life of somebody I love.” Dr. Jonathan M. RothbergFounder & ChairmanInterim CEOQuantum-Si QUANTUM SI 3
We build ecosystems toDigitize MedicineApply Deep Learning Enabled AIDemocratize Healthcare 4
We harness the power of semiconductor technology for Speed Simplicity Scale QUANTUM SI 5
90% Most diseases are linked to dysfunctional proteins, as humans share 99.9% of DNA sequence. 85% of the human proteome is currently undrugged2, potential for game changing drug development. of FDA-approved drugs target a protein Source(s): 1. The Human Proteome Tissue Atlas - Druggable Proteome, 2015, The Human Protein Atlas Project2. A Quest to Drug the Undruggable, June 2018, Chemical & Engineering News QUANTUM SI 6 Protein modifications are real-time indicators of health and disease, making them ideal markers for disease, drug response and health.
Current tools limit the use of protein biomarkers. Routine tests for Serum & Cerebrospinal Fluid (CSF) are constrained by number of analytes they can look at, sensitivity, and specificity. thousands research papers found of protein biomarkers 100 yet less than are routinely used in clinic1 150,000 QUANTUM SI 7 Source: 1.https://www.nature.com/articles/469156a
We Understand Digital Technologies Transform Markets Microarray DNA Sequencing Analog Digital Protein Sequencing Digital Affinity Arrays 20k genes 200k transcripts 1M+ proteoforms 1 cell Analog
Analog Affinity-based Approaches Digital Sequencing-based Approaches Identify known proteins Decode Novel Sequences SomaLogic Olink Nautilus Quantum-Si Encodia Erisyon Detection Method Aptamers Antibodies Aptamers / Antibodies Direct Real-Time N-terminal binding + Edman degradation with NGS readout Side chain labeling + Edman degradation with scanning Instrument Costs $$ - $$$(NGS Optional) $ - $$$(NGS Optional) $$$ $ $$ - $$$(NGS Required) $$ Run Costs $$ - $$$(NGS Optional) $ - $$$(NGS Optional) $$ - $$$ $ $$ - $$$ (NGS Required) $$ AA Sequencing NO NO NO YES LIMITED LIMITED Read Length Scaling N/A N/A N/A HIGH LOW LOW PTM Detection ?(Affinity Reagent) ?(Affinity Reagent) ?(Affinity Reagent) SCALABLE ? ? Notes *Can’t differentiate between proteoforms unless they create a specific affinity reagent Kinetics for amino acids & PTMs NGS erases quantitative information Harsh acidic environment limits utility Analog vs Digital Approaches to Proteomics
Q-Si End-to-End Proteomics Solution CARBON: $20,000Cartridge based sample preparation for Protein or DNA PLATINUM: $70,000Real Time, Massively Parallel, Single Molecule CONSUMABLES: $1,000/Each Library Prep & Protein Sequencing Sample Prep Sequencing & Cloud Analysis Kitted Reagents & Chips
Results Library Prep Loading Enrichment Sequencing Analyze sequence to discover new proteins, decode amino acid sequence & post-translational modifications Sequence by recognizing the amino acid at the end, removing it, and recognizing the next one Immobilize peptides in wells (2 Million wells per chip) Digest and add Linker for bar-coding and loading (multiple samples or single cell proteomics) Workflow for Q-Si Next-Gen Protein Sequencing™ Enrich proteins of interest F L Y I AFVILVEDSDDFRSEFKSDDKLIVFFDSEFRELFDERKSLSAWDSELKSELKILCSF AFVILVEDSDDFRSEFKSDDKLIVFFDSEFRELFDERKSLSAWDSELKSELKILCSF AFVILVEDSDDFRSEFKSDDKLIVFFDSEFRELFDERKSLSAWDSELKSELKILCSF
World’s First Massively Parallel Next-Gen Protein SequencingTM Additional details are available in our preprint on bioRxiv Library Preparation and Loading Protein Sequencing QUANTUM-SI
The Magic Enabling Broad Coverage of the Proteome While each protein is unique, the enzyme machines we engineer (aminopeptidases) have evolved to make all peptides behave the same in our system! QUANTUM SI 13
Fits into existing proteomic workflow. Universal Process for Protein Sequencing Cells Sub-cellular Fractionations Chromatography IP/Co-IP Gel Hormones Peptide Antigens Panels of Interest Single Protein/Complex C-Functionalization Digestion | K-Functionalization Post-Translational Modifications Amino Acid Sequence Protein Identification Serum Tissue Spinal Fluid
500+ Advanced Leads by Workflow Estimates based on 50% IP/Co-IP, 30% Chromatography, and 20% Gel of 500+ advanced leads
Collect Cerebrospinal Fluid (CSF) Biological & Clinical Challenge:Less than 1% of Alzheimer’s caused by an inherited single gene.Somatic mutations - mutations accumulated over a lifetime.Technical Challenge:Source of mutation not known.Mass spec is expensive, inconsistent, and often not sensitive enough.Solution:Sequencing of the peptides to identify changes in amino acid sequence. Alzheimer’s Risk Assessment How can you test for early onset Disease? Workflow CSF Library Prep Loading Sequencing Results LVFF LVLF Enrich Beta Amyloid from CSF Healthy Plaque forming Sequence 16
Metabolic Disease How can you identify modification of critical peptide hormones? Biological & Clinical Challenge:Heterogeneous populations of variants.Technical Challenge:Accuracy of detection for small mass differences is not consistent by mass spec.Sensitivity challenging for less abundant modifications.Solution:Immunoprecipitation and Sequencing of the peptides to identify point mutations. GFFYTPKWT Insulin Peptide GFLYTPKHyperproinsulinemia Insulin Peptide VFFYTPKPNDM Insulin Peptide Sequence Insulin Tissue / Biofluid Library Prep Loading Sequencing Results No action Proinsulin/Insulin ratio monitoring,Insulin resistance improvement therapy (pioglitazone) Insulin supplement therapy Enrich Insulin from blood 17
Drug Development Workflow Cell Line Library Prep Loading Sequencing Results How do you identify proteins that interact with target proteins of interest? Biological & Clinical Challenge:New proteins in my pathway?How does the complex change in disease?Technical Challenge:Routine, robust, scalable, sensitive tools to discover new proteins and post-translational modifications.Solution:Peptide sequencing to discover new proteins.Comparisons between samples to identify new post-translational modifications. (-) AKT Phosphorylation Add drug candidate to cell culture Co-Immunoprecipitation (+) AKT Phosphorylation F L I pY Drug response No drug response Sequence 18
Single Molecule, Single Atom Detection 1,000,000+ Protein Variations! Biological & Clinical Challenge:A protein’s modifications determine its function.What biomarkers can we discover?Technical Challenge:Impossible technical challenge to generate affinity reagents to ALL PTMs in context (over 1 million).Solution:Q-Si detects modifications without a priori knowledge.Powerful new method for comparing disease & treatment states to find biomarkers.Kinetics enable the detection of post-translational modifications; oxidation, phosphorylation, glycosylation (in the penultimate amino acids). L0.93 s M0.17 s L0.28 s No a priori knowledge needed to detect new biological markers. The oxidation of the penultimate residue is detected by a reduction in the average pulse duration of the N-terminal recognizer (as well as by the blocking of recognition of methionine when it becomes the N-terminal amino acid, as sequencing proceeds). 19 Biological Challenge:Proteoforms are a potentially rich source of clinically relevant information and new biomarkersTechnical Challenge:Open ended questions, so can’t develop affinity reagents at start.Solution:Q-Si Sequencing is powerful for comparing biological states (eg disease & treatment) for proteoform-based biomarkers.Rich untapped biomarker opportunity.
Buy $200k benchtop MALDI?Send out sample to Mass Spec core? Can do a Western.But no Antibody identifies it or explains the difference. Sequence with convenient,easy to own benchtop box Workflow Gel Band Library Prep Loading Sequencing Results Sequence Proteins Like we Sequence DNA Biological & Clinical Challenge:What is this protein?How is it modified?Technical Challenge:Weeks waiting for answers from a mass spec core facility.Antibodies don’t provide new insights.Solution:Discover new proteins of interest.Identify new protein variations and post-translational modification. Proteomics Core on Your Benchtop Gel purified protein What is the second band? 20
Future of Therapy Selection Profiling Cancers to Guide Therapy Workflow Clinical Challenge:Survival depends on early correct therapy selection and modifications of treatment regimens.Technical Challenge:Genetic tests detect chromosomal aberrations, not protein alterations.Disease instability requires frequent testing & new understanding.Solution:Q-Si Sequencing enables biomarkers select therapy. Tissue / Biofluid Library Prep Loading Sequencing Results Immunoprecipitate 5-10 proteins from biopsy Chemotherapy Sequence Radiation therapy F L Y I MDM2 P16 kinase VEGFR p53 MTA1 21
Enabling Personalized Medicine Identify Antigens for Personalized Immunotherapy or to Understand Infection Workflow Clinical Challenge:Highly diverse peptides of unknown origin.Need to identify modifications.Technical Challenge:Peptides missed by mass specRelevant neoantigens or antigenic pathogens relatively low abundant.Solution:Q-Si sequencing to identify antigen targets.Understanding of new Covid Variants. Tissue / Biofluid Library Prep Loading Sequencing Results Isolate antigen presenting cells Elute MHC peptides Assess infection (long-haul COVID) Sequence Synthesize personal cancer vaccine F L Y I 22
Goals for Commercial Launch ~70% loading of proteome after library prep into 5 to 25 amino acid long peptides200,000+ reads per run, with 10 to 20 reads for each high confidence call5 to 50+ proteins over 3 or 4 logs concentration range
Roadmap for Customer Adoption & Growth Research DrivenAdoption Clinical Use to ExpandUser Base & Increase Utilization 2021 2025 Expand Coverage of Proteome ✅ Scaled Production/Supply Chain Early Access UnderstandKey Influencers Initial Launch2022 Product Updates2023 Portfolio Expansion2024 Consumables Devices
to fund work through 2024 ~$470 M With team members that invented and commercialized the first Next Generation DNA Sequencing and put DNA sequencing on a Semiconductor chip, we are well positioned to launch the World’s First Next-Generation Protein Sequencing Experienced team of 150+ QUANTUM SI 25
Oncology drove Next Generation DNA Sequencing Immunology, Immuno-oncology & Infectious Disease will drive Next-Gen Protein Sequencing™ QUANTUM SI 26 Catalyst for Success
The firstto bring Next-Gen DNA Sequencing to market The visionto bring Moore’s Law to DNA Sequencing The teamto bring Next-Gen Protein Sequencing™ to the world