HTG Molecular Diagnostics Reports First Quarter 2021 Results and Provides a Corporate Update
HTG Molecular Diagnostics reported financial results for Q1 2021, showing total revenue of $1.4 million, down from $2.2 million in Q1 2020, attributed to COVID-19 impacts. The net loss decreased to $4.6 million, with a net loss per share of $(0.80). The company is progressing on its transcriptome panel using HTG EdgeSeq technology, with anticipated commercialization by Q3 2021. Cash and equivalents stood at $30.8 million. The ongoing Early Adopter Program has seen increased participation, refining study details with over 25 collaborators from academia and pharma.
- Progress in developing a transcriptome panel with potential as an alternative to RNA-Seq.
- Increased participation in the Early Adopter Program with over 25 collaborators.
- Anticipated commercialization of the transcriptome panel by Q3 2021.
- Total revenue decreased from $2.2 million in Q1 2020 to $1.4 million in Q1 2021 due to COVID-19.
- Net loss remains significant at $4.6 million, despite a decrease from $5.4 million in the prior year.
Call scheduled for today, May 13, at 4:30 pm ET
TUCSON, Ariz., May 13, 2021 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today reported its financial results for the first quarter ended March 31, 2021.
Recent Business Highlights
● Released a second technical white paper (White Paper Two) characterizing the company’s planned transcriptome panel using the HTG EdgeSeq technology. White Paper Two, among other things, compares the performance and feasibility of a prototype of HTG’s planned transcriptome panel to RNA sequencing (RNA-Seq) across multiple cancer indications. White Paper Two also demonstrates the feasibility and expected performance of the transcriptome panel, including:
○ Ability to differentiate samples based on gene expression profiles;
○ Repeatability amongst replicates from multiple cancer indications with archived samples;
○ Accuracy of differential expression analysis using a direct comparison to RNA-Seq;
○ Potential as a robust alternative to RNA-Seq for gene expression profiling while maintaining the advantages of the HTG EdgeSeq technology.
With the feasibility testing for all elements of the panel’s design complete, the company is now in the optimization phase of development, working to further improve the panel’s design, workflow, and robustness. Having completed our final round of probe quality control testing, defined our quality control metric strategy and finalized the reagent formulation during the quarter, we have ordered our final probe pool for the panel. Final panel design lock is anticipated in the second quarter of 2021 followed by formal panel design verification with initial commercialization anticipated by the third quarter of 2021.
● Increased participation in the company’s transcriptome panel Early Adopter Program (EAP), refining study details with over 25 collaborators to date, including those in both academia and pharma. The EAP allows a select group of customers access to the initial transcriptome panel for use in their laboratories or through services performed by HTG prior to commercial launch of the panel.
“Our team continues to be very optimistic about the launch of the transcriptome panel using our HTG EdgeSeq technology,” said John Lubniewski, President and CEO of HTG. “Data published in our second white paper highlight the potential of this panel as a robust, clinically deployable alternative to RNA-Seq for gene expression profiling. We believe the benefits of our HTG EdgeSeq technology and the transcriptome panel, including ease of use, cost savings, turnaround time and broad applicability, will make this a very attractive alternative for gene expression profiling applications. We continue to meet our development milestones and look forward to providing updates on our progress in the coming months.”
“In the fourth quarter of 2020, our base business showed signs of recovery after experiencing a substantial impact from COVID-19 in the second and third quarters of 2020. The reopening process stalled again in the first quarter of 2021 in Europe and our pharmaceutical company customers have continued a slow return to pre-COVID-19 clinical trial levels. We are hopeful of a return to pre-COVID revenue levels as vaccinations become more widely available and business continues to normalize,” Mr. Lubniewski continued.
First Quarter 2021 Financial Highlights:
Total revenue for the first quarter ended March 31, 2021 was
Product and product-related services revenue was
There was no collaborative development services revenue for the quarter ended March 31, 2021, compared with
Net loss from operations for the first quarter ended March 31, 2021 was
Cash, cash equivalents and short-term available-for-sale securities totaled
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: | Thursday, May 13, 2021 | |
| Time: | 4:30 p.m. Eastern Time | |
| Toll Free: | (877) 407-0789 | |
| International: | (201) 689-8562 | |
| Conference ID: | 13719223 | |
| Webcast: | http://public.viavid.com/index.php?id=144644 | |
| About HTG: | ||
| HTG is focused on NGS-based molecular profiling. The company’s proprietary HTG EdgeSeq technology automates complex, highly multiplexed molecular profiling from solid and liquid samples, even when limited in amount. HTG’s customers use its technology to identify biomarkers important for precision medicine, to understand the clinical relevance of these discoveries, and ultimately to identify treatment options. Its mission is to empower precision medicine. | ||
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 anticipated performance characteristics and benefits of our planned transcriptome panel, the related Early Access Program, the impact of strategic adjustments made to lessen the impact of COVID-19, our belief that direct revenue from our core oncology business will begin to recover to pre-COVID levels, and the expected timing of the commercial launch of our transcriptome panel. Words such as “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 may not provide the benefits that we expect; 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 without limitation our Quarterly Report on Form 10-Q for the period ended March 31, 2021. 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 Robinson
Phone: (617) 430-7577
Email: arr@lifesciadvisors.com
| -Financial tables follow- | ||||||||
| HTG Molecular Diagnostics, Inc. | ||||||||
| Consolidated Statements of Operations | ||||||||
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Revenue: | ||||||||
| Product and product-related services | $ | 1,435,146 | $ | 1,988,137 | ||||
| Collaborative development services | — | 237,337 | ||||||
| Total revenue | 1,435,146 | 2,225,474 | ||||||
| Operating expenses: | ||||||||
| Cost of product and product-related services revenue | 785,200 | 1,015,492 | ||||||
| Selling, general and administrative | 3,859,619 | 4,675,263 | ||||||
| Research and development | 1,372,040 | 1,926,275 | ||||||
| Total operating expenses | 6,016,859 | 7,617,030 | ||||||
| Operating loss | (4,581,713 | ) | (5,391,556 | ) | ||||
| Other income (expense), net | (264,145 | ) | (61,166 | ) | ||||
| Net loss before income taxes | (4,845,858 | ) | (5,452,722 | ) | ||||
| Provision for income taxes | (2,449 | ) | (5,176 | ) | ||||
| Net loss | $ | (4,848,307 | ) | $ | (5,457,898 | ) | ||
| Net loss per share, basic and diluted | $ | (0.80 | ) | $ | (1.27 | ) | ||
| Shares used in computing net loss per share, basic and diluted | 6,040,752 | 4,304,529 | ||||||
| HTG Molecular Diagnostics, Inc. | ||||||||
| Consolidated Balance Sheets | ||||||||
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 21,777,687 | $ | 22,397,812 | ||||
| Short-term investments available-for-sale, at fair value | 8,987,844 | 6,298,075 | ||||||
| Accounts receivable | 1,250,048 | 1,588,767 | ||||||
| Inventory, net | 1,602,874 | 1,492,126 | ||||||
| Prepaid expenses and other | 1,530,203 | 1,094,273 | ||||||
| Total current assets | 35,148,656 | 32,871,053 | ||||||
| Operating lease right-of-use assets | 349,074 | 1,009,097 | ||||||
| Property and equipment, net | 1,124,258 | 1,227,402 | ||||||
| Other non-current assets | 5,853 | 90,356 | ||||||
| Total assets | $ | 36,627,841 | $ | 35,197,908 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,352,837 | $ | 1,348,762 | ||||
| Accrued liabilities | 1,114,810 | 1,459,878 | ||||||
| Contract liabilities - current | 493,869 | 185,083 | ||||||
| NuvoGen obligation - current | 479,403 | 512,729 | ||||||
| Current portion of long-term debt | 4,501,741 | 3,022,139 | ||||||
| Operating lease liabilities - current | 373,946 | 685,220 | ||||||
| Other current liabilities | 20,293 | 22,563 | ||||||
| Total current liabilities | 8,336,899 | 7,236,374 | ||||||
| NuvoGen obligation - non-current, net of discount | 4,354,839 | 4,479,396 | ||||||
| Long-term debt, net | 7,046,617 | 8,568,308 | ||||||
| Operating lease liabilities - non-current | — | 368,682 | ||||||
| Other non-current liabilities | 49,424 | 60,488 | ||||||
| Total liabilities | 19,787,779 | 20,713,248 | ||||||
| Commitments and Contingencies | ||||||||
| Total stockholders’ equity | 16,840,062 | 14,484,660 | ||||||
| Total liabilities and stockholders' equity | $ | 36,627,841 | $ | 35,197,908 | ||||
FAQ
What were HTGM's total revenues for Q1 2021?
How did HTGM's net loss change in Q1 2021 compared to Q1 2020?
What is the anticipated timeline for HTGM's transcriptome panel commercialization?
How many collaborators are involved in HTGM's Early Adopter Program?
What factors contributed to HTGM's revenue decline in Q1 2021?
