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8-K
0001850906false00018509062021-11-092021-11-09

 

 

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): November 9, 2021

 

 

Singular Genomics Systems, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

001-40443

81-2948451

(State or other jurisdiction
of incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

10931 N. Torrey Pines Road, Suite #100
La Jolla, California 92037

 

(858) 333-7830
(Registrant’s address of principal executive offices

and telephone number, including area code)

 

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 Registered

Common Stock, par value $0.0001 per share

 

OMIC

 

Nasdaq Global Select Market

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 November 9, 2021, Singular Genomics Systems, Inc. (the “Company”) issued a press release regarding the Company’s financial results for the quarter ended September 30, 2021. A copy of the press release is attached as Exhibit 99.1 and incorporated herein by reference.



The information in this Item 2.02 and the press release attached as Exhibit 99.1 hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall such information be deemed incorporated by reference in any 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

99.1

Press Release dated November 9, 2021

104

Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document.

 

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Singular Genomics Systems, Inc.

 

 

 

 

Dated:

November 9, 2021

By:

/s/ Dalen Meeter

 

 

 

Dalen Meeter
Senior Vice President, Finance
Principal Financial Officer and Principal Accounting Officer

 

 
EX-99.1

https://cdn.kscope.io/d8f63100153caf0b299700af6ae3f7a4-img160378605_0.jpg 

 

Singular Genomics Systems, Inc. Reports Recent Highlights and Third Quarter Financial Results

 

La Jolla, CA, November 9, 2021 – Singular Genomics Systems, Inc. (Nasdaq: OMIC), a company focused on delivering genomic technologies for the advancement of science and medicine, today highlighted recent corporate achievements and reported financial results for the third quarter of 2021.

 

“Early access partnerships for the G4 have been successful, and our partners are achieving accuracy and performance measures at our intended targeted specs. We are grateful for the collaboration of our partners at these pioneering labs as we establish robust installation protocols, further enhance system performance and lock in manufacturing operations,” said Drew Spaventa, Chairman and Chief Executive Officer. “We remain on track for our commercial launch, to take orders by year end and to ship commercial systems during the first half of 2022. The commercial team is ramping to drive instrument placements and deliver an unparalleled customer experience.”

 

Recent Highlights

Achieved targeted performance specifications at three Early Access Program (EAP) partners’ labs with the G4 Integrated Solution. Results from next generation sequencing (NGS) runs performed by partners demonstrated the following:
o
Harvard’s Beth Israel Deaconess Medical Center achieved average read counts of 136 million per flow cell and accuracy of 99.6%–99.7% utilizing targeted sequencing panels requiring 100 cycle kits.
o
Site 2 achieved average read counts of greater than 150 million per flow cell and accuracy of 99.6%–99.8% utilizing targeted sequencing panels requiring 150 cycle kits.
o
Site 3 achieved average read counts of greater than 170 million per flow cell and accuracy of approximately 99.8% utilizing targeted panels and exome libraries requiring 200 cycle kits.

 

Added an additional three EAP partners, for a total of six, to further validate the G4 performance specifications across various applications and lab settings that represent our targeted early customers and markets.

 

G4 commercial launch remains on track for the end of 2021. As part of commercial launch, we plan to include the release of specifications and pricing for the G4 instrument and initial consumable kit configurations, publish a technical report and provide known data sets for evaluation by prospective customers. Preparations are underway to accept limited orders from thought leading organizations by year end with initial shipments targeted during the first half of 2022.

 

Advanced operational readiness through continued hiring of manufacturing, customer support, sales and other commercial personnel and completed the buildout of a dedicated manufacturing facility to support the launch and anticipated initial demand for both the G4 and PX Integrated Solutions.

 

 

Financial Results

Operating expenses for the third quarter of 2021 totaled $17.5 million, compared to $7.8 million for the third quarter of 2020. Operating expenses for the third quarter of 2021 included non-cash stock-based compensation of $2.9 million. The year-over-year increase in operating expenses was driven primarily by headcount growth, investments to support the G4 commercial launch and continued investment in the PX Integrated Solution development.

 

Net loss for the third quarter of 2021 was $17.6 million, or $0.25 per common share, compared to $7.9 million, or $0.74 per common share, for the third quarter of 2020.

 

Cash, cash equivalents and short-term investments, excluding restricted cash, at September 30, 2021 totaled approximately $357.0 million.

 

Webcast and Conference Call Details

Singular Genomics’ management team will host a conference call today, November 9, 2021, beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. Investors interested in listening to the conference call may do so by accessing a live and archived webcast of the event at www.singulargenomics.com, on the Investors page in the Presentations & Events section.

 

About Singular Genomics Systems, Inc.

Singular Genomics is a life science technology company that is leveraging novel, next generation sequencing (NGS) and multiomics technologies to build products that empower researchers and clinicians. Our mission is to accelerate genomics for the advancement of science and medicine. Our Singular Sequencing Engine is the foundational platform technology that forms the basis of our products in development as well as our core product tenets: accuracy, speed, flexibility and scale. We are currently developing two integrated solutions that are purpose built to target applications in which these core product tenets matter most. Our first integrated solution, the G4 Integrated Solution, is targeted at the NGS market. Our second integrated solution in development, the PX Integrated Solution, combines single cell analysis, spatial analysis, genomics and proteomics in one integrated instrument to offer a versatile multiomics solution. The G4 and PX Integrated Solutions are both comprised of an instrument and an associated menu of consumable kits.

 

 

Forward-Looking Statements

Certain statements contained in this press release, other than historical information, constitute forward-looking statements within the meaning of the Federal securities laws. Forward-looking statements include, but are not limited to, statements regarding: (i) our ability to successfully complete the development of our G4 and PX Integrated Solutions; (ii) our ability to meet our commercial launch and product delivery timelines and objectives; and (iii) our ability to achieve customer and scientific acceptance for our G4 and PX Integrated Solutions. Any such forward-looking statements are based on our management’s current expectations and are subject to a number of risks and uncertainties that could cause our actual future results to differ materially from our management’s current expectations or those implied by the forward-looking statements. These risks and uncertainties include, but are not limited to: (i) we have incurred significant losses since inception, we expect to incur significant losses in the future and we may not be able to generate sufficient revenue to achieve and maintain profitability; (ii) we have no history commercializing our products or technology; (iii) the life sciences technology market is highly competitive, and if we fail to compete effectively, our business and operating results will suffer; (iv) if we are sued for infringing, misappropriating or otherwise violating intellectual property rights of third parties, this litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates; (v) if our products fail to achieve early customer and scientific acceptance, we may not be able to achieve broader market acceptance for our products, and our revenues and prospects may be harmed; and (vi) the COVID-19 pandemic and efforts to reduce its spread have adversely impacted, and may materially and adversely impact, our business and operations. These and other risk factors that may affect our future results of operations are identified and described in more detail in our filings with the SEC, including our Quarterly Report on Form 10-Q for period ended September 30, 2021, filed with the SEC on November 9, 2021. Accordingly, you should not rely upon forward-looking statements as predictions of future events or our future performance. Except as required by applicable law, we undertake no obligation to update publicly or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

 

Investor Contact

Matt Clawson

949-370-8500

ir@singulargenomics.com

 

Media Contact

Dan Budwick, 1AB

973-271-6085

dan@1abmedia.com

 

 

 

Singular Genomics Systems, Inc.

Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

8,910

 

 

$

6,080

 

 

$

23,200

 

 

$

15,431

 

Selling, general and administrative

 

8,551

 

 

 

1,698

 

 

 

18,406

 

 

 

4,518

 

Total operating expenses

 

17,461

 

 

 

7,778

 

 

 

41,606

 

 

 

19,949

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(17,461

)

 

 

(7,778

)

 

 

(41,606

)

 

 

(19,949

)

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

91

 

 

 

76

 

 

 

223

 

 

 

444

 

Interest expense

 

(234

)

 

 

(202

)

 

 

(654

)

 

 

(503

)

Change in fair value of convertible promissory notes

 

-

 

 

 

-

 

 

 

(35,199

)

 

 

-

 

Change in fair value of warrant liability

 

-

 

 

 

(49

)

 

 

(2,180

)

 

 

(49

)

Other (expense) income

 

(7

)

 

 

20

 

 

 

405

 

 

 

24

 

Net loss

$

(17,611

)

 

$

(7,933

)

 

$

(79,011

)

 

$

(20,033

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

$

(0.25

)

 

$

(0.74

)

 

$

(2.05

)

 

$

(1.91

)

Weighted-average shares used to compute basic and diluted net loss per share

 

71,721,861

 

 

 

10,726,496

 

 

 

38,553,685

 

 

 

10,507,732

 

 

 

Singular Genomics Systems, Inc.

Condensed Balance Sheets

(In thousands, except share and par value amounts)

 

 

 

 September 30,

 

 

 December 31,

 

 

 

2021

 

 

2020

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

239,263

 

 

$

11,688

 

Short-term investments

 

 

117,750

 

 

 

15,231

 

Prepaid expenses and other current assets

 

 

7,214

 

 

 

652

 

Total current assets

 

 

364,227

 

 

 

27,571

 

Property and equipment, net

 

 

4,917

 

 

 

2,368

 

Restricted cash

 

 

687

 

 

 

482

 

Other noncurrent assets

 

 

1,000

 

 

 

81

 

Total assets

 

$

370,831

 

 

$

30,502

 

 

 

 

 

 

 

 

Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,390

 

 

$

427

 

Accrued expenses

 

 

3,443

 

 

 

1,592

 

Current portion of long-term debt, net of issuance costs

 

 

-

 

 

 

926

 

Warrant liability

 

 

-

 

 

 

451

 

Other current liabilities

 

 

158

 

 

 

294

 

Total current liabilities

 

 

5,991

 

 

 

3,690

 

Long-term debt, net of issuance costs

 

 

9,868

 

 

 

8,469

 

Other noncurrent liabilities

 

 

2,904

 

 

 

714

 

Total liabilities

 

 

18,763

 

 

 

12,873

 

Commitments and contingencies

 

 

 

 

 

 

Convertible preferred stock, $0.0001 par value:

 

 

 

 

 

 

Series Seed, 6,520,790 shares authorized, 0 and 6,520,790 issued and outstanding at September 30, 2021 and December 31, 2020, respectively; liquidation preference of $0 and $4,499,998 at September 30, 2021 and December 31, 2020, respectively

 

 

-

 

 

 

4,486

 

Series A, 12,932,429 shares authorized, 0 and 12,932,429 issued and outstanding at September 30, 2021 and December 31, 2020, respectively; liquidation preference of $0 and $20,000,002 at September 30, 2021 and December 31, 2020, respectively

 

 

-

 

 

 

19,908

 

Series B, 19,566,903 shares authorized, 0 and 19,373,169 issued and outstanding at September 30, 2021 and December 31, 2020, respectively; liquidation preference of $0 and $44,999,997 at September 30, 2021 and December 31, 2020, respectively

 

 

-

 

 

 

44,790

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

Common stock, $0.0001 par value; 400,000,000 and 60,272,685 shares authorized, 71,934,170 and 10,816,937 of shares outstanding at September 30, 2021 and December 31, 2020, respectively

 

 

7

 

 

 

1

 

Additional paid-in capital

 

 

484,202

 

 

 

1,552

 

Accumulated other comprehensive (loss) gain

 

 

(5

)

 

 

17

 

Accumulated deficit

 

 

(132,136

)

 

 

(53,125

)

Total stockholders’ equity (deficit)

 

 

352,068

 

 

 

(51,555

)

Total liabilities, convertible preferred stock and stockholders’ equity

 

$

370,831

 

 

$

30,502