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In Brief This Week: MDxHealth, Co-Diagnostics, HTG Molecular Diagnostics, Immunovia, and More

NEW YORK – MDxHealth said this week that its initial public offering in the US of 3,750,000 American Depositary Shares (each representing 10 of the company’s ordinary shares) has increased its share capital to 118.7 million ($135.8 million) from 90.1 million, and that the number of its issued and outstanding shares has increased to 155,969,226 ordinary shares from 118,469,226 ordinary shares through the issuance of a total of 37.5 million new shares. The IPO closed on Nov. 8.

Co-Diagnostics this week posted revenues for the third quarter of 2021 of $30.1 million, up 38 percent year over year primarily due to sales of its Logix Smart COVID-19 Test Kit. For the quarter ended Sept. 30, the Salt Lake City-based molecular diagnostics company posted net income of $11.5 million, or $.38 per share, compared to net income of $15.7 million, or $.53 per share, in the third quarter of 2020. At the end of Q3, the firm had cash, cash equivalents, and marketable securities of $83.9 million.

Co-Diagnostics' Q3 R&D expenses rose more than sixfold year over year to $5.9 million compared to $921,889, while its SG&A expenses rose 140 percent year over year to $7.2 million compared to $3.0 million.

The firm noted that during the recently completed quarter, its joint venture firm CoSara received clearance from India's Central Drugs Standard Control Organization for chikungunya and dengue tests. Co-Diagnostics also obtained approval to sell its Logix Smart ABC (Influenza A/B, SARS-CoV-2) Test Kit in Mexico and Logix Smart COVID-19 Test Kit in Brazil.

For full year 2021, the company expects its revenue will be between $96.0 million and $100.0 million and its diluted earnings per share will be between $1.07 and $1.16.

HTG Molecular Diagnostics reported this week that its third quarter revenues increased 42 percent year over year to $2.5 million from $1.8 million, reflecting an increase in instrument sales and research-use-only sample processing services. HTG trimmed its Q3 net loss to $4.2 million, or $.60 per share, from $5.2 million, or $1.12 per share a year ago. The company's Q3 SG&A expenses fell 13 percent to $4.2 million from $4.8 million, while its R&D spending edged up 15 percent to $1.5 million from $1.3 million. HTG Molecular finished the quarter with $25.4 million in cash, cash equivalents, and short-term available-for-sale securities.

Swedish diagnostic firm Immunovia said this week that its third quarter sales rose tenfold to SEK 377,000 ($43,300) from SEK 37,000 a year ago. The company also said it had a net loss of SEK 36.1 million, or SEK 1.60 per share, for the three months ended Sept. 30, compared to a net loss of SEK 38.1 million, or SEK 1.68 per share, a year ago.

Epigenomics said this week that its revenues for the first nine months of 2021 grew significantly to €6.0 million ($6.9 million) from €541,00 a year ago. The company attributed the increase to €5.7 million in sales of samples from its biobank in the recently completed quarter. Product revenues, meanwhile, declined 27 percent to €453,000 from €330,000 due to the COVID-19 pandemic. Epigenomics had a net loss of €691,000, or €.07 per share, for the first nine months of 2021 compared to a net loss of €9.1 million, or €1.59 per share, a year ago. Its R&D costs decreased 35 percent to €2.2 million from €3.4 million and its sales and administrative costs grew 7 percent to €5.8 million from €5.4 million. Epigenomics had cash and cash equivalents of €23.6 million as of Sept. 30. The firm also revised its revenue guidance for full-year 2021 to €6 million from a previous estimate of €400,000 to €1 million, due to the sale of its biobank to New Horizon Health.

Prenetics this week reported more than a tenfold increase in year-over-year revenues for the first half of 2021, driven by continued demand for its genomic and diagnostic testing services, including increased demand for COVID-19 testing. For the six months ended June 30, the Hong Kong-based firm booked $136.5 million in revenues, up from $12.0 million in the first half of 2020. As of June 30, Prenetics had $37.6 million in cash and $60.3 million in trade receivables. The company increased its revenue guidance for full-year 2021 to more than $205 million and said it is on track to go public through a merger with special purpose acquisition company Artisan Acquisition, a transaction it expects to close in the first quarter of 2022. Prenetics offers its Circle HealthPod system for COVID-19 testing and is developing Circle ColoClear, a noninvasive stool-based FIT-DNA test for colorectal cancer screening, and Circle SnapShot, an at-home blood test.

Cytek Biosciences this week reported a 37 percent increase in year-over-year revenues for the third quarter. For the three months ended Sept. 30, the Fremont, California-based cell analysis company, which went public in July, booked $34.4 million in revenues, compared to $25.1 million in Q3 of 2020. Net income for the quarter was $1.6 million compared to $6.5 million during the year-ago period. Cytek did not report its earnings per share. R&D expenses almost doubled to $6.1 million in Q3 from $3.4 million a year ago, and SG&A costs more than doubled to $12.2 million in Q3 from $5.5 million in the same quarter last year. As of Sept. 30, Cytek had $376.7 million in cash and cash equivalents.

Israel-based rapid, point-of-care testing firm PixCell Medical said this week it has opened a US subsidiary in the Denver metropolitan area. The new site will increase logistical and commercial support for the firm's US customers, as well as fulfill orders across the country and provide technical and clinical support to customers.

Sona Nanotech said this week it has reached a binding licensing agreement to license the intellectual property for its rapid, saliva-based COVID-19 test to Arlington Scientific. Springville, Utah-based Arlington will work to gain Emergency Use Authorization from the US Food and Drug Administration for use of the test at the point of care and at home. If EUA is granted, Arlington will coordinate manufacturing and distribution of the test in the US on a profit-sharing basis. Arlington will also receive part of Halifax, Nova Scotia-based Sona's profits from international sales of the test, Sona said.

Genomtec this week reported third quarter revenues of PLN 33,600 ($8,478) compared to PLN 2,000 in the prior-year quarter. The Wroclaw, Poland-based genetic test developer said Q3 proceeds from grants were PLN 332,000 compared to PLN 832,700 a year earlier. The company reported a Q3 net loss of PLN 947,500 compared to a net loss of PLN 368,500 a year earlier.

In Q3, the firm continued the development of its Genomtec ID mobile platform for genetic testing at the point of care. According to Genomtec's website, the platform includes an analyzer and reaction card with integrated genetic tests and provides multiplexing of up to five genetic targets at the same time.

Bayer and nonprofit organization The Life Raft Group this week announced a research collaboration to expand access to comprehensive genomic testing for gastrointestinal stromal tumor patients. The program will offer comprehensive genomic testing for free to GIST patients who have not previously received genetic testing and who agree to be part of The Life Raft Group GIST Patient Registry. The partners hope to expand screening for GIST patients beyond testing for single genes, like c-KIT, PDGFRA, and BRAF, and to use comprehensive genomic testing to identify more GIST patients who harbor NTRK fusions. Bayer's TRK inhibitor larotrectinib (Vitrakvi) is approved in the US to treat solid tumors with NTRK gene fusions, including GIST.

SEngine Precision Medicine and Dana-Farber Cancer Institute this week announced a collaboration to make the company’s diagnostic test PARIS available to adult and pediatric patients with primary or metastatic solid-tumor central nervous system cancers. Dana-Farber's Center for Patient Derived Models will develop live tumor models from a biopsy or resection of patients' tumors and those models will be analyzed at SEngine's lab. The PARIS test assesses up to 44 drugs and drug combinations against each patient's tumor and ranks the therapies in a report to aid treatment selection.

CareDx said this week that it has acquired New Jersey-based MedActionPlan, a provider of medication safety and adherence technology and patient education for transplant patients. Terms of the deal were not disclosed.

CareDx said the deal adds to its goal of connecting offerings for transplant patients. MedActionPlan offers MedActionPlan PRO, a medication management and adherence platform to simplify post-transplant medication regimens; MyMedSchedule Plus, a companion mobile app that works with MedActionPlan PRO to provide patients with up-to-date medication schedules and medication reminders to reinforce adherence; and the Patient Connect and MedActionPlan Dashboard, a tool that allows the healthcare team to monitor a patient’s progress and send medication schedule updates.

Canadian on-demand virtual pharmacy Mednow has acquired the license and exclusive distribution rights to epigenetic testing kits from US-based company TruDiagnostic. The deal covers TruDiagnostic’s TruAge Complete Collection, which enables a patient to analyze methylation biomarkers to quantify the process of aging including biological age, immune age, and telomere length, the companies said. Mednow paid a one-time licensing fee of $150,000 for rights to the technology, which it said will enhance its approach to provide a "full-spectrum healthcare ecosystem" in Canada.

Caris Life Sciences said this week that the Georgia Cancer Center at Augusta University has joined its Precision Oncology Alliance, a collaborative network of 55 leading cancer centers and academic institutions seeking to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology.

Georgia Cancer Center leads the state’s only minority-based research program through the National Cancer Institute’s Community Oncology Research Program. The cancer center is also on its way to achieving NCI designation, which would give it national recognition as a leader in cancer research, including clinical trials. By joining Caris' POA, the center gains early access to the firm's extensive database and Molecular Intelligence platform, as well as to a network of precision medicine clinical trials and collaborative opportunities with other alliance members.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.