UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
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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 2.02 Results of Operations and Financial Condition.
On May 11, 2023, Talis Biomedical Corporation (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2023. A copy of the press release is attached hereto as Exhibit 99.1.
The information contained under this Item 2.02, including Exhibit 99.1 attached hereto are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall they be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 7.01 Regulation FD Disclosure.
On May 11, 2023, the Company posted an investor presentation to its website at https://investors.talisbio.com. A copy of the investor presentation is attached hereto as Exhibit 99.2.
The information contained under this Item 7.01, including Exhibit 99.2 attached, hereto are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall they be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit |
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Description |
99.1 |
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99.2 |
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104 |
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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.
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Talis Biomedical Corporation |
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Date: |
May 11, 2023 |
By: |
/s/ Rebecca L. Markovich |
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Rebecca L. Markovich |
Exhibit 99.1
Talis Biomedical Announces Business Update and First Quarter 2023 Financial Results
Conference call and webcast today at 4:30pm Eastern/1:30pm Pacific
REDWOOD CITY, Calif. – May 11, 2023 – Talis Biomedical Corporation (Nasdaq: TLIS), a diagnostic company dedicated to advancing health equity and outcomes through the delivery of accurate infectious disease testing in the moment of need, at the point of care, today announced a business update and reported financial results for the first quarter ended March 31, 2023.
Business Update
“With significant advances in our manufacturing capabilities, a clearly defined product menu and disciplined regulatory strategy to minimize risk, Talis Biomedical is executing on our plan to deliver multiple women’s and sexual health test panels at the point of care,” said Rob Kelley, chief executive officer of Talis Biomedical. “We are well capitalized and have an experienced team in place to unlock this large and untapped $3 billion market with our differentiated Talis One system.”
First Quarter 2023 Financial Results
Revenue was $1.2 million for the first quarter of 2023, compared to $3.2 million for the same period in 2022. This includes $1.1 million of NIH grant revenue and $0.1 million of product revenue from antigen testing sales.
Operating expenses were $20.2 million in the first quarter of 2023, compared to $36.2 million for the same period in 2022. The decrease was primarily driven by lower antigen test and raw card inventory expenses and the realization of benefits from the cost reduction measures implemented during 2022. The Company also incurred $3.1 million of non-recurring expenses to obtain a license to patents and cartridge raw materials in connection with the termination of a supply agreement with one of its contract manufacturers.
Net loss was $17.8 million for the first quarter of 2023, compared to $33.1 million for the same period in 2022.
Cash and Liquidity
Unrestricted cash and cash equivalents as of March 31, 2023, were $113.0 million.
Net cash used in operating activities for the first quarter of 2023 was $16.5 million, as compared to $43.8 million in the first quarter of 2022. This decrease was primarily driven by lower headcount costs from the Company’s spending reduction program as well as declines in payments for antigen test and raw card inventory.
About Talis Biomedical
Talis Biomedical is dedicated to advancing health equity and outcomes through the delivery of accurate infectious disease testing in the moment of need, at the point of care. The company plans to develop and commercialize innovative products on its sample-to-answer Talis One®system to enable accurate, low cost, and rapid molecular testing. For more information, visit talisbio.com.
Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as “may,” “might,” “will,” “would,” “should,” “believe,” “expect,” “anticipate,” “could,” “estimate,” “continue,” “predict,” “potential,” “forecast,” “project,” “plan,” “intend” or similar expressions, or other words that convey uncertainty of future events or outcomes can be used to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our plans to advance our pipeline, including the plans to develop Talis One assays in the women’s and sexual health markets; the size and potential of our opportunity in the women’s and sexual health markets; our ability to capitalize on any competitive advantages; our ability to position the Company to provide durable value to our shareholders; the benefits of our regulatory strategy; our future revenue growth and profit margins; and our ability to lower our cash burn, extend operations and extend our cash runway. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: risks and uncertainties associated with development and regulatory approval, the impact to our business from global economic conditions, including inflationary pressures, the ongoing COVID-19 pandemic and any related impact on our ability to develop our pipeline products, our ability to achieve or sustain profitability, our ability to launch and gain market acceptance for our pipeline products and to accurately forecast and meet customer demand, our ability to compete successfully, our ability to enhance our product offerings, development and manufacturing, capacity constraints or delays in production of our products, product defects or failures. These and other risks and uncertainties are described more fully in the “Risk Factors” section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our 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 cautioned not to unduly rely upon these statements. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Talis assumes no obligation to updates forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.
Contact
Media & Investors
Emily Faucette
efaucette@talisbio.com
415-595-9407
Talis Biomedical Corporation
Condensed Balance Sheets
(in thousands)
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March 31 |
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December 31, |
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2023 |
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2022 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ 112,959 |
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$ 130,191 |
Restricted cash |
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1,010 |
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— |
Accounts receivable, net |
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127 |
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308 |
Prepaid expenses and other current assets |
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1,492 |
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2,783 |
Total current assets |
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115,588 |
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133,282 |
Property and equipment, net |
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3,634 |
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3,312 |
Operating lease right-of-use-assets |
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12,289 |
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30,920 |
Other long-term assets |
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1,542 |
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1,776 |
Total assets |
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$ 133,053 |
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$ 169,290 |
Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ 3,871 |
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$ 3,768 |
Accrued compensation |
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2,733 |
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4,212 |
Accrued liabilities |
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1,614 |
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989 |
Operating lease liabilities, current portion |
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2,962 |
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3,703 |
Total current liabilities |
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11,180 |
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12,672 |
Operating lease liabilities, long-term portion |
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11,749 |
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29,879 |
Total liabilities |
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$ 22,929 |
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$ 42,551 |
Stockholders’ equity: |
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Series 1 convertible preferred stock |
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3 |
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3 |
Common stock |
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3 |
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3 |
Additional paid-in capital |
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605,903 |
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604,687 |
Accumulated deficit |
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(495,785) |
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(477,954) |
Total stockholders’ equity |
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110,124 |
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126,739 |
Total liabilities and stockholders’ equity |
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$ 133,053 |
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$ 169,290 |
Talis Biomedical Corporation
Condensed Statements of Operations and Comprehensive Loss (Unaudited)
(in thousands)
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Three Months Ended March 31, |
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2023 |
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2022 |
Revenue |
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Grant revenue |
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$ 1,081 |
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$ 874 |
Product revenue, net |
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137 |
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2,313 |
Total revenue, net |
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1,218 |
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3,187 |
Operating expenses: |
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Cost of products sold |
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20 |
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3,521 |
Research and development |
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13,796 |
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20,703 |
Selling, general and administrative |
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6,399 |
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11,930 |
Total operating expenses |
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20,215 |
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36,154 |
Loss from operations |
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(18,997) |
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(32,967) |
Other income (expense), net |
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1,166 |
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(84) |
Net loss and comprehensive loss |
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$ (17,831) |
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$ (33,051) |
Talis Biomedical Corporate Presentation May 2023 Decentralizing Women’s and Sexual Health Testing
Disclaimer This presentation may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these words or other similar terms or expressions. Talis Biomedical (“Talis Bio,” “we,” “our”) has based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and results of operations. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our plans to advance our pipeline, including our plans to develop Talis One assays in the women’s and sexual health markets; the size and potential of our opportunity in the women’s and sexual health markets; our ability to capitalize on any competitive advantages; the potential to realize the benefit of our restructuring plan in the fourth quarter of 2022; our ability to position Talis Bio to provide durable value to our shareholders; our future revenue growth and profit margins; and our ability to lower our cash burn, extend operations and our cash runway. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: risks and uncertainties associated with development and regulatory approval, the impact to our business from global economic conditions, including the ongoing COVID-19 pandemic, and inflationary pressures and any related impact on our ability to develop our pipeline products, our ability to achieve or sustain profitability, our ability to launch and gain market acceptance for our pipeline products and to accurately forecast and meet customer demand, our ability to compete successfully and our ability to enhance our product offerings, development and manufacturing, capacity constraints or delays in production of our products, product defects or failures. These and other risks and uncertainties are described more fully in the “Risk Factors” section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Any forward-looking statements that we make in this presentation speak only as of the date of this presentation, and Talis Bio assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this presentation, except as required under applicable law. This presentation also contains estimates and information concerning our industry and business, including estimated market size and projected growth rates of the markets in which Talis Bio participates. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Talis Bio has not independently verified the statistical and other industry data generated by independent parties and contained in this presentation and, accordingly, we cannot guarantee their accuracy or completeness. In addition, projections, assumptions and estimates of our future performance and the future performance of the industries in which we operate are necessarily subject to a high degree of uncertainty and risk due to a variety of factors. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by Talis Bio.
Differentiated to Lead in Significant Untapped Market Advancing health equity and outcomes by delivering accurate infectious disease testing in the moment of need, at the point of care Talis One® System Established innovative, high-performing diagnostic platform at the point of care PROMISING PIPELINE OPPORTUNITY Refocused product roadmap in growing women’s and sexual health markets OPERATIONAL OPTIMIZATION Demonstrated scalable manufacturing capabilities with path to attractive margins WELL-POSITIONED FOR COMMERICIALIZATION Built strong commercial infrastructure
Women’s/Sexual Health Providers Eager to Test at Point-of-Care (POC) INHERENT CLINICAL ADVANTAGE Accurate, immediate treatment reduces empirical prescribing, office visits and patients lost to follow-up ECONOMIC BENEFIT Shifts reimbursement to those providing care COVID ACCELERATED POC PLATFORM ADOPTION Created demand and channel for broader infectious disease testing at the point of care
Large and Growing Market Opportunity 1. BofA Merrill Lynch Global Research, 2015; 2. Talis Bio management estimates; 3. https://health.gov 2018 Tailwinds will accelerate and sustain transition from lab-based testing to POC Incidence of STIs increasing and a growing public-health priority Patients are becoming engaged consumers, expecting convenience and immediacy Physicians want test results while patients are there Practices seeking new, profitable revenue streams Untapped opportunity with only 56% of sexually active females aged 16-24 screened for chlamydial infections3 40M CT, NG + TV tests performed annually1 24M UTI, Vaginitis, GBS + HSV tests performed annually2 $3B U.S. market opportunity with 2022 W&SH testing converted to POC2
The Talis One System is Designed to Win in POC Market SENSITIVITY & SPECIFICITY Embedded Sample Prep, Nucleic Acid Extraction RAPID TURNAROUND Results in <30 Minutes DESIGNED FOR UNTRAINED USERS CLIA Waiver for POC Market RELEVANT MENU Women’s & Sexual Health Menu + Respiratory LOW COST Automated Manufacturing Drives Down Cost
Talis One System Technology Overview
Differentiated to Lead in Women’s/Sexual Health Market POC sample-to-result in <30 minutes Demonstrated ease of use for untrained users1 Integrated DNA/RNA extraction, purification, detection and results management Proven to lyse difficult pathogens in <4 minutes2 Multiple system interface capabilities or standalone function 1. Talis Bio internal usability studies, external IUO studies, and expert evaluations; 2. Yeast and gram+ bacteria, Internal Talis Bio feasibility studies CLOUD SOFTWARE INSTRUMENT CONSUMABLE
Onboard Precision Sample Metering Labeled for Human and Instrument Reading Multiplexed Reaction Plugs Robust Mechanical Lysis Easy Sample Loading Solid-Phase Nucleic Acid Purification Closed-System Design Reduces Contamination Risk Integrated Test Cartridge Enables Sample Prep, Menu Expansion Self-Contained, Single Use Consumable
Designed for Untrained User Touchscreen Interface Cloud Connectivity Flexible Multiplexing Instrument Designed for Ease-of-Use
3 Simple Steps to Rapid, Accurate Results Results 1 Label with patient ID: Barcode or handwritten 2 Add specimen to cartridge 3 Insert cartridge into instrument
>$100M investment in automated manufacturing to deliver 1M tests/month at full scale High speed assembly lines consistently produce cartridges Ability to build instruments efficiently Talis One System performing well in hands of study users Established Ability to Manufacture at Scale Investment in automation provides advantages of quality, throughput and cost
Three Tiers of Cartridge Manufacturing Lines Provide Flexibility and Stability as Business Scales 1 Assumes one 8-hour shift; 2 Assumes operating all three lines simultaneously 1. Manual 2. Semi Automated 3. Fully Automated Business Use Research & Development Clinical Studies/Early Commercialization Full-Scale Commercialization Capacity 300 cartridges/day 2,000 cartridges/day1 40,000 cartridges/day2 Benefit Flexibility to customize production for different assays in small batches Additional volume with some customization and lower card to card variability Volume to support commercial scale and attractive margins Location Redwood Shores, CA (Talis) Chicago, IL (Talis) Phoenix, AZ (Contract Manufacturer)
Delivering Clinical and Economic Value to Physicians Minimal capital costs and lower practice overhead with better informed diagnosis and treatment Pricing below established CPT codes Redirects reimbursement from central lab to providers
Not All POC Tests are Created Equal Does it include sample preparation to ensure lab-quality results? Can it generate a result in less than 30 minutes while the patient is in the office? Can an untrained user operate? Can it deliver multiplex panels with difficult to lyse organisms to meet customer needs? Can it be produced at scale for low cost? Talis One Uniquely Positioned to Meet Key Customer Needs RAPID TURNAROUND Results in <30 Minutes SENSITIVITY & SPECIFICITY Embedded Sample Preparation, Nucleic Acid Purification CLIA Waiver for POC Market EASE OF USE LOW COST Automated Manufacturing Drives Down Cost RELEVANT MENU High-Value Women’s and Sexual Health Tests Important Questions to Ask
Prioritizing Assay Development to Accelerate Market Entry Symptomatic patients Nasopharyngeal swab Ob/Gyn demand confirmed 510(k) pre submission complete Asymptomatic and Symptomatic patients Vaginal swab (physician and self collection) Female and male urine 510(k) pre submission complete CT/NG/TV Chlamydia trachomatis, neisseria gonorrhoeae and trichomonas vaginalis Vaginal Panel Bacterial vaginosis, vulvovaginal candidiasis and trichomonas vaginalis BV / CV / TV Volume Driver Platform Differentiator Respiratory Panel Influenza A, Influenza B and SARS-CoV-2 Market Entrant HSV-1/2 Herpes Simplex Virus oral and genital HSV-1 / 2 Platform Differentiator Symptomatic patients Vaginal swab Assay design underway Symptomatic patients Vaginal swab Feasibility studies underway Multi color detection and ability to lyse yeast on cartridge demonstrated 1 2 3 4
Roadmap for Menu Expansion Planning Feasibility Development Clinical Trials Regulatory Submission Respiratory Panel CT/NG/TV HSV 1/2 Vaginal Panel Group B Strep UTI
Talis Biomedical Wins Over Time Nascent and growing $3B U.S. market opportunity addressing women’s and sexual health testing Talis One System designed to deliver accuracy, speed, and ease of use High-value efficient product roadmap and clear path to attractive margins Capitalized to execute strategy into 2025 with cash ending 1Q23 of $113M Large unmet need with shifting diagnostic testing from centralized labs to the point of care
Thank you.