EX-99.1 2 tlis-ex991_6.htm EX-99.1 tlis-ex991_6.htm

Exhibit 99.1

 

Talis Biomedical Announces Second Quarter 2021 Financial Results and Business Progress

Conference call and webcast today at 4:30pm Eastern/1:30pm Pacific

 

MENLO PARK, Calif. – August 10, 2021 – Talis Biomedical Corporation (Nasdaq: TLIS), a company dedicated to developing innovative molecular diagnostic tests for infectious diseases at the point-of-care, today reported financial results and business progress for the second quarter ended June 30, 2021.  

 

"During the second quarter, we made meaningful progress on the execution of our strategic business initiatives, including the successful completion of our point-of-care clinical validation study for the Talis One™ COVID-19 assay and subsequent EUA submission to the FDA in July,” said Brian Coe, Chief Executive Officer of Talis. “As we prepare for commercial launch of this first assay, continue to optimize our manufacturing capabilities and broaden our test menu, we are building our core foundation for the future to meet the needs of the large and growing respiratory, sexual health and women’s health testing markets.”

 

Business Updates

 

 

Completed a clinical validation study for Talis One COVID-19 assay in a point-of-care environment to support an Emergency Use Authorization (EUA) application submission to the FDA.

 

Conducted analysis of 10 distinct COVID-19 variants through the NIH RADx program demonstrating high sensitivity of detection.  At the time of testing in June, the emerging Delta variant was not available to be included in this study. Subsequently, a small internal study showed correct identification of the delta variant in clinical specimens.  

 

Submitted an EUA application for Talis One System and Talis One COVID-19 Assay to the FDA on July 23, 2021.

 

Completed installation and are in the final stages of validation for the first set of automated cartridge production lines.

 

Second Quarter 2021 Financial Results

 

Revenue was $0.1 million for the second quarter of 2021, as compared to $0.8 million in the same period in 2020. The revenue for the second quarter of 2021 was grant revenue related to an NIH grant.

 

Operating expenses were $64.5 million in the second quarter of 2021, compared to $10.8 million in the same period in 2020. The increase in operating expenses was primarily driven by investments in manufacturing scale-up and development of the first test using the Talis One system.  

 

Net loss was $64.5 million for the second quarter of 2021, compared to $10.0 million for the same period in 2020.

 

Cash and cash equivalents on June 30, 2021, were $313.5 million, and restricted cash was $34.7 million.

 

Conference Call and Webcast Details

The company will host a live conference call and webcast to discuss these results and provide a corporate update on Tuesday, August 10, 2021, at 4:30 PM ET / 1:30 PM PT.

 

 


 

 

To participate in the call, please dial (833) 715-1329 (domestic) or (430) 755-1933 (international) and provide conference ID 5966606. The live webcast will be available on the News & Events page of the investors section of Talis Biomedical’s website at talisbio.com.

 

About Talis Biomedical

Talis is dedicated to transforming diagnostic testing by developing and commercializing innovative products that are designed to enable accurate, low cost, and rapid molecular testing for infectious diseases at the point-of-care. The company is developing the Talis One, a compact, sample-to-answer, cloud-enabled, molecular diagnostic platform. 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," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "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 commercialize Talis One following regulatory authorization; our future ability to meet the needs of the large and growing respiratory, sexual health and women’s health testing markets; and our ability to grow and expand our business.  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: the impact to our business of the ongoing COVID-19 pandemic, including any impact on our ability to market our products, demand for our products due to deferral of procedures using our products or disruption in our supply chain, our ability to achieve or sustain profitability, our ability to gain market acceptance for our products and to accurately forecast and meet customer demand, our ability to compete successfully, our ability to enhance our product offerings, development and manufacturing problems, capacity constraints or delays in production of our products, maintenance of coverage and adequate reimbursement for procedures using 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 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.

 

Investor Contact

Media & Investors
Emily Faucette
efaucette@talisbio.com
415-595-9407

 


 

 

Talis Biomedical

Consolidated Balance Sheet

(In thousands)

(Unaudited)


 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

313,458

 

 

$

138,483

 

Restricted cash

 

 

34,650

 

 

 

34,650

 

Grants receivable

 

 

 

 

 

238

 

Unbilled grants receivable

 

 

117

 

 

 

233

 

Prepaid research and development expenses

 

 

2,431

 

 

 

12,014

 

Prepaid expenses and other current assets

 

 

3,209

 

 

 

3,106

 

Total current assets

 

 

353,865

 

 

 

188,724

 

Property and equipment, net

 

 

10,178

 

 

 

9,114

 

Operating lease right-of-use-assets

 

 

13,747

 

 

 

567

 

Other long-term assets

 

 

1,748

 

 

 

 

Total assets

 

$

379,538

 

 

$

198,405

 

Liabilities and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

11,695

 

 

$

4,906

 

Accrued compensation

 

 

5,291

 

 

 

2,738

 

Accrued liabilities

 

 

54,761

 

 

 

7,694

 

Operating lease liabilities, current portion

 

 

882

 

 

 

693

 

Total current liabilities

 

 

72,629

 

 

 

16,031

 

Operating lease liabilities, long-term portion

 

 

13,177

 

 

 

 

Total liabilities

 

$

85,806

 

 

$

16,031

 

 

 

 

 

 

 

 

 

 

Convertible preferred stock

 

 

 

 

 

290,945

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

 

 

Series 1 convertible preferred stock

 

 

3

 

 

 

 

Common stock

 

 

2

 

 

 

 

Additional paid-in capital

 

 

591,597

 

 

 

64,335

 

Accumulated deficit

 

 

(297,870

)

 

 

(172,906

)

Total stockholders’ equity (deficit)

 

 

293,732

 

 

 

(108,571

)

Total liabilities, convertible preferred stock and stockholders’ equity

 

$

379,538

 

 

$

198,405

 

 

 


 

 

 

 


Talis Biomedical

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Grant revenue

 

$

117

 

 

$

820

 

 

$

7,117

 

 

$

1,219

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

54,495

 

 

 

8,184

 

 

 

114,688

 

 

 

13,898

 

Selling, general and administrative

 

 

9,983

 

 

 

2,660

 

 

 

17,310

 

 

 

4,740

 

Total operating expenses

 

 

64,478

 

 

 

10,844

 

 

 

131,998

 

 

 

18,638

 

Loss from operations

 

 

(64,361

)

 

 

(10,024

)

 

 

(124,881

)

 

 

(17,419

)

Other expense, net

 

 

(111

)

 

 

(22

)

 

 

(83

)

 

 

(1

)

Net loss and comprehensive loss

 

$

(64,472

)

 

$

(10,046

)

 

$

(124,964

)

 

$

(17,420

)

Net loss per share, basic and diluted

 

$

(2.51

)

 

$

(4.75

)

 

$

(6.44

)

 

$

(8.23

)

Weighted average shares used in the calculation of net loss per share, basic and diluted

 

 

25,648,151

 

 

 

2,116,623

 

 

 

19,414,066

 

 

 

2,116,437