htgm-8k_20211110.htm
false 0001169987 0001169987 2021-11-10 2021-11-10

 

 

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

November 10, 2021

Date of Report (Date of earliest event reported)

 

HTG Molecular Diagnostics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-37369

 

86-0912294

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

3430 E. Global Loop

Tucson, AZ

 

85706

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (877289-2615

 

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 obligations 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, $0.001 par value per share

 

HTGM

 

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 2.02 Results of Operations and Financial Condition.

On November 10, 2021, HTG Molecular Diagnostics, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2021. A copy of this press release is attached hereto as Exhibit 99.1.

The information in this Item 2.02 and the attached exhibit 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 incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

 

Exhibit

No.

 

Description

 

 

 

99.1

 

Press release of HTG Molecular Diagnostics, Inc. dated November 10, 2021

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.

 

 

 

HTG Molecular Diagnostics, Inc.

 

 

 

 

 

Dated: November 10, 2021

 

By:

 

/s/ Shaun D. McMeans

 

 

 

 

Shaun D. McMeans

 

 

 

 

SVP and Chief Financial Officer

 

 

htgm-ex991_6.htm

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

HTG Molecular Diagnostics Reports Third Quarter 2021 Results

 

Call scheduled for today, November 10, at 4:30 pm ET

 

TUCSON, Ariz., November 10, 2021 -- HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling technology, today reported its financial results for the quarter ended September 30, 2021.

 

 

Recent Business Highlights

 

 

Total revenue for the quarter ended September 30, 2021 increased by approximately 42% when compared to the same period in 2020.  

 

 

HTG Transcriptome Panel revenue increased in the third quarter and accounted for 27% and 18% of consumables product revenue for the three and nine months ended September 30, 2021, respectively.

 

 

Continued collaboration with participants in the Early Adopter Program (EAP) for the Company’s HTG Transcriptome Panel (HTP) throughout the US and EU who are exploring potential applications for the panel in their research and clinical programs. EAP collaborators are expected to assist HTG with customer testimonials, white papers, technical notes and peer-reviewed publications highlighting their use of the HTP and their overall experience relative to alternative technologies.

 

 

Completed an audit of HTG’s quality management system for continued certification to ISO 13485:2016, valid through June 2024.

 

 

Announced the creation of a drug discovery business unit, HTG Therapeutics, and the hiring of the leadership team for the unit. HTG Therapeutics is expected to leverage HTG’s proprietary RNA profiling technology platform to inform advanced chemical library designs seeking to improve efficacy and lower toxicity profiles for drug candidates. The team has signed up several KOL’s to assist in the development of a portfolio of potentially licensable drug candidates for drug discovery. This effort is aimed at the generation of high-quality primary data from our proprietary profiling platform from known and well annotated cohorts and overcoming the notable shortfalls of data mined from public sources. HTG Therapeutics intends to leverage the Company’s past experience partnering with biopharma to collaborate throughout the drug development process, with a view toward creating future revenue and opportunities for HTG.

 

“Our profiling revenue has continued to grow quarter over quarter in 2021, reflecting the efforts of our employees and our customers’ response to and recovery from the challenges imposed on our industry and by the many challenges we faced as a company in 2020,” said John Lubniewski, President and CEO of HTG. “Increasing instrument placements resulting from the reopening of customer facilities and increased sample processing activity in our VERI/O laboratory drove our quarterly growth. A resurgence of consumable product orders from existing and new customers is expected to drive continued growth in our product revenue. Our commercial team remains focused on our strategic priorities of customer and market diversification, while continuing to strengthen relationships with our existing customers.

 


“We will continue this drive throughout the remainder of 2021, with expected increasing demand for our HTP,” Mr. Lubniewski added. Our HTG Therapeutics team continues to make strides toward our vision for disrupting drug discovery by using advanced transcriptomic profiling capabilities to de-risk drug candidate development.”

 

Third Quarter 2021 Financial Highlights:

Total revenue for the quarter ended September 30, 2021 was $2.5 million, compared with $1.8 million for the same period in 2020.

 

Product and product-related services revenue increased by 48% for the quarter ended September 30, 2021 to $2.5 million, compared with $1.7 million for the same period in 2020. This reflects an increase in instrument sales and RUO sample processing services for which demand has begun to recover to pre-COVID-19 levels as customers have resumed development activities. Revenue for the quarter ended September 30, 2020 included $0.1 million of collaborative development services revenue.

 

Net loss from operations for the quarter ended September 30, 2021 was $4.2 million, compared with $5.2 million for the same period in 2020. Net loss per share was $(0.60) for the quarter ended September 30, 2021 compared with $(1.12) for the third quarter of 2020.

 

Cash, cash equivalents and short-term available-for-sale securities totaled $25.4 million as of September 30, 2021, with current liabilities of approximately $8.1 million and non-current liabilities of $11.5 million.

 

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

 

Date:

 

Wednesday, November 10, 2021

Time:

 

4:30 p.m. Eastern Time

Toll Free:

 

(877) 407-0789

International:

 

(201) 689-8562

Conference ID:

 

13721188

Webcast:

 

http://public.viavid.com/index.php?id=145556

 

About HTG:

HTG is accelerating precision medicine from diagnosis to treatment by harnessing the power of transcriptome-wide profiling to drive translational research, clinical diagnostics and targeted therapeutics across a variety of disease areas.

 

Building on more than a decade of pioneering innovation and partnerships with biopharma leaders and major academic institutes, HTG’s proprietary RNA platform technologies are designed to make the development of life science tools and diagnostics more effective and efficient and to unlock a differentiated and disruptive approach to transformative drug discovery. For more information visit www.htgmolecular.com.



 

Safe Harbor Statement:

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected contributions from EAP collaborators, capabilities of the HTG Transcriptome Panel, the expected performance and benefits of HTG Therapeutics, future revenue opportunities, expected continued growth in product revenue, trends in our core business, and our ability to grow our business. Words such as “designed to,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, risks associated with the impact of the COVID-19 pandemic on us and our customers; the risk that our transcriptome panel and advanced chemical library designs may not provide the benefits that we expect; risks associated with our lack of experience in drug discovery and related collaborations; risks associated with our ability to develop and commercialize our products, including our transcriptome panel; the risk that our products and services may not be adopted by biopharmaceutical companies or other customers as anticipated, or at all; our ability to manufacture our products to meet demand; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of our Annual Report on Form 10‑K for the year ended December 31, 2020 and our most recently filed quarterly report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

Contact:

 

Ashley R. Robinson
LifeSci Advisors, LLC
Phone: (617) 430-7577
Email: arr@lifesciadvisors.com

 

 

-Financial tables follow-



 

 

HTG Molecular Diagnostics, Inc.

 

Condensed Consolidated Statements of Operations

 

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

 

 

2020

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product and product-related services

 

$

2,520,410

 

 

 

 

$

1,701,068

 

 

$

6,029,760

 

 

$

5,417,731

 

Collaborative development services

 

 

 

 

 

 

 

76,030

 

 

 

 

 

 

548,135

 

Total revenue

 

 

2,520,410

 

 

 

 

 

1,777,098

 

 

 

6,029,760

 

 

 

5,965,866

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Cost of product and product-related services revenue

 

 

983,761

 

 

 

 

 

940,892

 

 

 

2,740,004

 

 

 

2,931,026

 

     Selling, general and administrative

 

 

4,232,313

 

 

 

 

 

4,752,321

 

 

 

11,995,747

 

 

 

13,683,069

 

     Research and development

 

 

1,534,818

 

 

 

 

 

1,255,416

 

 

 

4,188,219

 

 

 

4,914,467

 

Total operating expenses

 

 

6,750,892

 

 

 

 

 

6,948,629

 

 

 

18,923,970

 

 

 

21,528,562

 

Operating loss

 

 

(4,230,482

)

 

 

 

 

(5,171,531

)

 

 

(12,894,210

)

 

 

(15,562,696

)

Other income (expense), net

 

 

(258,206

)

 

 

 

 

(238,676

)

 

 

(774,820

)

 

 

(482,599

)

Gain on forgiveness of PPP Loan

 

 

 

 

 

 

 

 

 

 

1,735,792

 

 

 

 

Loss on extinguishment of MidCap Credit

    Facility and QNAH Convertible Note

 

 

 

 

 

 

 

 

 

 

 

 

 

(522,394

)

Net loss before income taxes

 

 

(4,488,688

)

 

 

 

 

(5,410,207

)

 

 

(11,933,238

)

 

 

(16,567,689

)

Provision for income taxes

 

 

(1,934

)

 

 

 

 

(1,581

)

 

 

(20,643

)

 

 

(12,548

)

Net loss

 

$

(4,490,622

)

 

 

 

$

(5,411,788

)

 

$

(11,953,881

)

 

$

(16,580,237

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.60

)

 

 

 

$

(1.12

)

 

$

(1.78

)

 

$

(3.68

)

Shares used in computing net loss per share, basic and diluted

 

 

7,440,287

 

 

 

 

 

4,821,562

 

 

 

6,727,916

 

 

 

4,504,469

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

HTG Molecular Diagnostics, Inc.

 

Condensed Consolidated Balance Sheets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

September 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

(Unaudited)

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

10,229,646

 

 

$

22,397,812

 

Short-term investments available-for-sale, at fair value

 

 

15,187,672

 

 

 

6,298,075

 

Accounts receivable

 

 

1,904,534

 

 

 

1,588,767

 

Inventory, net

 

 

2,340,766

 

 

 

1,492,126

 

Prepaid expenses and other

 

 

2,082,410

 

 

 

1,094,273

 

Total current assets

 

 

31,745,028

 

 

 

32,871,053

 

 

 

 

 

 

 

 

 

 

Operating lease right-of-use assets

 

 

1,444,348

 

 

 

1,009,097

 

Property and equipment, net

 

 

1,219,190

 

 

 

1,227,402

 

Other non-current assets

 

 

98,828

 

 

 

90,356

 

Total assets

 

$

34,507,394

 

 

$

35,197,908

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,145,868

 

 

$

1,348,762

 

Accrued liabilities

 

 

1,609,001

 

 

 

1,459,878

 

Contract liabilities - current

 

 

213,462

 

 

 

185,083

 

NuvoGen obligation - current

 

 

530,657

 

 

 

512,729

 

Current portion of long-term debt

 

 

4,167,107

 

 

 

3,022,139

 

Operating lease liabilities - current

 

 

398,313

 

 

 

685,220

 

Other current liabilities

 

 

17,558

 

 

 

22,563

 

Total current liabilities

 

 

8,081,966

 

 

 

7,236,374

 

NuvoGen obligation - non-current, net of discount

 

 

4,072,831

 

 

 

4,479,396

 

Long-term debt, net

 

 

6,309,416

 

 

 

8,568,308

 

Operating lease liabilities - non-current

 

 

1,055,984

 

 

 

368,682

 

Other non-current liabilities

 

 

99,825

 

 

 

60,488

 

Total liabilities

 

 

19,620,022

 

 

 

20,713,248

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

Total stockholders’ equity

 

 

14,887,372

 

 

 

14,484,660

 

Total liabilities and stockholders' equity

 

$

34,507,394

 

 

$

35,197,908