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OPERATIONAL HIGHLIGHTS & 2021 FINANCIAL RESULTS
Commercialization of Nu.Q Vet
On March 29, 2022, VolitionRx VNRX introduced the signing of an unique License and Provide Settlement with Heska Company HSKA for the distribution of the Nu.Q Vet Most cancers Screening Check on the point-of-care for companion animals. Heska is a rising veterinary well being laboratory diagnostic programs firm specializing in point-of-care checks, analyzers and specialty merchandise for canines and felines in North America (62.6% of revenues) and 9 worldwide markets.
VolitionRx acquired a $10 million upfront cost on signing (in late-March) and can obtain as much as an extra $18 million primarily based upon the achievement of sure milestones. Initially, the licensing settlement grants unique rights to commercialize Nu.Q Vet for canine most cancers screening and monitoring on the level of care. Heska will provide the Nu.Q Vet take a look at on its proprietary Component i+ Immunodiagnostic Analyzer point-of-care platform, which was launched in 2020. Component i+ is designed to ship take a look at ends in minutes.
Additionally, Heska has been granted non-exclusive rights to promote the Nu.Q Vet take a look at kits by means of its reference laboratory community. The cost for the kits and key elements shall be at pre-agreed costs, which ought to present one other income stream for VolitionRx.
VolitionRx estimates that the entire addressable market (TAM) worldwide for most cancers screening and monitoring in canines and felines to be about $11 billion. The managements of VolitionRx and Heska share the identical imaginative and prescient of with the ability to present inexpensive diagnostic checks that allow the early detection and therapy of well being situations with a view to obtain higher outcomes. Nu.Q Vet checks are anticipated to be provided at a value level of underneath $50 per equipment (of which VolitionRx will obtain round $10), which can place the take a look at as a mass market product with the goal of supporting medical selections throughout annual check-ups, wellness exams and healthcare therapies. Consequently, an ongoing income stream is predicted to be generated by offering kits and key elements to veterinarians world wide.
The commercialization course of is anticipated to take at the very least six months as Nu.Q Vet take a look at is customized to Heska’s Component i+ point-of-care platform, and probably on Heska’s multiplexed Heska panels. Revenues could possibly be generated as early as late 2022.
As well as, in mid-December 2021, VolitionRx entered into non-exclusive License and Provide Settlement with SAGE Healthcare Non-public Restricted for the Nu.Q Vet Most cancers Screening Check in Asia. Preparations for the launch of the Nu.Q Vet take a look at into centralized labs in Singapore are at present in progress.
Nu.Q Assays Offered at ASCO GI 2022
In February 2022, VolitionRx introduced two posters of research knowledge at 2022 ASCO Gastrointestinal Cancers Symposium:
• Circulating nucleosomes ranges enhance FIT efficiency for detecting high-risk colorectal neoplasms in a symptomatic inhabitants (n=476 sufferers enrolled)
• Circulating nucleosomes for detection of colorectal most cancers and high-risk superior adenomas (n=520 average-risk asymptomatic sufferers)
The 476-patient research is encouraging in that Volition’s Nu.Q assays (H3K36Me3 and H3K9Me3) when used along with the FIT (Fecal Immunochemical Check) seems to detect CRC (colorectal most cancers) and all high-risk superior adenomas, each proximal and distal, in symptomatic sufferers. Probably, pointless colonoscopy could possibly be lowered by 28%. The subsequent step is to facilitate an unbiased, potential validation research.
The 520 -patient research of average-risk asymptomatic sufferers indicated that two completely different Volition’s Nu.Q assays (H3K27Me3 and H3R8Cit) of the seven examined, when along with the FIT, might probably scale back pointless colonoscopies by over 20%. Simultaneous checks of sure nucleosome ranges seem to reinforce the standard of diagnoses since the usage of the FIT alone generates false-positives within the neighborhood of 60%.
The research have been undertaken by VolitionRx and the Division of Inner Medication on the Nationwide Taiwan College Hospital.
Nu.Q NETs CE Mark Registration
Administration intends to finish the CE Mark certification course of in Europe for the corporate’s Nu.Q NETs assay. Volition plans to register the Nu.Q H3.1 NETs assay with a broad declare for detecting and monitoring ailments with a NETs part (e.g. sepsis, COVID-19, influenza, autoimmune ailments and most cancers) and throughout a number of platforms (ELISA plate, automated beads and so forth.). Administration expects the CE Mark registration course of to be accomplished by the summer season of 2022.
The corporate is growing a U.S. medical research for the aim of acquiring FDA approval of Nu.Q NETs. A pilot research is predicted to start later in 2022.
Nu.Q Seize
The primary two medical papers regarding Nu.Q Seize (A Novel Proteomics Method to Epigenetic Profiling of Circulating Nucleosomes and Serial profiling of cell-free DNA and nucleosome histone modifications in cell cultures) have been printed within the first half of 2021. The second half noticed the continued recruitment of crew members for Nu.Q Seize analysis on the innovation hub in San Diego. A number of strategies for enrichment have been recognized, together with utilizing Nu.Q Seize together with sequencing, different Nu.Q assays and mass spectrometry. Additionally, Nu.Q Seize expertise was used within the poster (regarding canines with lymphoma) that was introduced on the VCS Society Annual Convention.
VolitionRx is now engaged on growing a big 1,000+ affected person research within the areas of lung most cancers and colorectal most cancers.
Silver One
Throughout 221, a Service Lab was put in in Silver One. Through the second quarter, Volition offered quotes to a number of pharmaceutical and biotechnology firms for processing samples underneath the Nu.Q Uncover moniker. A handful of contracts have been at present within the negotiation part close to the tip of 2021.
On the year-end convention name (March 31, 2022), it was introduced that the first Nu.Q Uncover settlement was signed in 2021. An extra 5 contracts have been signed in early 2022; these contracts have an mixture annual value of barely over $200,000.
Nu.Q Most cancers – Updates on ongoing human research in hematological, lung and colorectal cancers)
Updates on Giant-Scale Blood, Lung and CRC Scientific Trials
On-going Giant-scale Examine of Colorectal Most cancers (CRC) Scientific Trial in Asia
The medical knowledge of the 5,000-subject asymptomatic screening research and the 2,000-subject symptomatic research, together with the information logs, have been analyzed in the course of the third quarter of 2021. The preliminary findings have been introduced in two posters on the 2022 ASCO Gastrointestinal Cancers Symposium in mid-February 2022.
On-going Giant-scale “Marquee” Examine for Lung Most cancers in Asia
Volition has accomplished preliminary evaluation of the lung most cancers research and abstracts have been submitted for displays at two (2) lung most cancers conferences to be held later in 2022.
On-going Scientific Trial for Prognosis of Non-Hodgkin’s Lymphoma (NHL) within the U.S.
On account of delays brought on by the COVID-19 pandemic, the research protocol of the 1,500-subject NHL research was altered with a view to improve to a high-throughput platform, which ought to help within the FDA approval course of. Recruitment for the altered research is now anticipated to start within the second quarter of 2022.
On-going Giant-scale “Marquee” Examine for Colorectal Most cancers (CRC) within the U.S.
In June 2021, collections resumed for EDRN (Early Detection Analysis Community) research; enrollments have been sluggish, however regular. The EDRN continues to anticipate that the research shall be accomplished within the fourth quarter of 2022.
Milestones Anticipated Through the The rest of 2022
• Nu.Q Vet Most cancers
◦ Achievement of Heska Settlement milestones with a view to obtain $18 million in milestone funds
◦ Further bulletins of licensing settlement(s) for the distribution of Nu.Q Vet Most cancers Screening Check nationally and/or internationally. VolitionRx continues to be in negotiations with 2 different firms.
• Silver One: Beneath the Nu.Q Uncover program, six contracts for processing samples using Nu.Q Discovery assays have been signed in late-2021 and the primary quarter of 2022. These contracts have an mixture annual value of barely over $200,000, however are anticipated to ramp up slowly all through 2022, however significantly within the second half.
• Nu.Q NET
◦ Administration expects to obtain CE Mark certification for Nu.Q NET in Europe in the course of the summer season.
◦ In an effort to acquire FDA approval of Nu.Q NETs, a pilot research is predicted to start later in 2022.
• Further Papers, Posters and/or Abstracts
◦ Nu.Q Vet
▪ The outcomes of a medical research with over 100 canines is in progress with the outcomes are anticipated to be submitted in a peer-reviewed publication in 2022. Preliminary knowledge recommend that Nu.Q Vet might be able to detect {that a} canine is popping out of remission weeks previous to the present methodology of bodily detection.
▪ The evaluation of over 600 canines, 504 of that are most cancers sufferers, has been accepted for publication by a veterinary journal and is at present underneath evaluation.
◦ Giant-scale Examine of Lung Most cancers Performed in Asia – The findings have been submitted for presentation at two conferences later in 2022.
Full 12 months 2021 Monetary Outcomes
On March 30, 2022, after the market shut, VolitionRx reported monetary outcomes for the fourth quarter and full 12 months ending December 31, 2021. Whole revenues for 2021 have been $90,035, which consisted of product income from direct gross sales of the Nu.Q Vet Most cancers Screening Exams being processed by the GI (Gastrointestinal) laboratory at Texas A&M College.
Whole working bills elevated 33.7% from $21.3 million to $28.4 million. R&D bills elevated 6.9% to roughly $15.5 million, primarily as a consequence of increased personnel bills and stock-based compensation. The variety of Full Time Equal (FTE) personnel elevated 21% from 47 to 57. G&A bills elevated 54.8% to $8.75 million, additionally pushed by personnel bills and stock-based compensation, together with elevated legal responsibility insurance coverage and authorized charges. Gross sales and advertising bills elevated 285%, pushed by increased personnel, stock-based compensation and direct advertising bills. On this division, the variety of FTE personnel elevated by 333% from three to 10. In all three expense classes, administration elevated the stock-based compensation part to a extra aggressive stage with a view to appeal to and retain staff.
For 2021, VolitionRx reported a internet lack of $26.81 million (or $0.51 per diluted share) versus a internet lack of roughly $20.35 million (or $0.45 per diluted share) in 2020.
The corporate’s money burn price is roughly $2.0 million per 30 days. As of December 31, 2021, working capital was roughly $15.46 million, a slight enchancment over the $14.10 million on December 31, 2020. The corporate has a robust steadiness sheet with barely above $20.58 million in money & money equivalents. As a part of the Heska world licensing & provide settlement, VolitionRx acquired $10.0 million close to the tip of the primary quarter of 2022.
Throughout 2021, Volition acquired internet proceeds of $23.22 million by means of the issuance of shares and was awarded $1.52 million in grant earnings from Walloon Area. Shares excellent elevated by 9.5% to 53,223,761 shares from 48,607,017 shares on December 31, 2020.
Throughout 2021, Volition acquired internet proceeds of roughly $4.6 million by means of the corporate’s aftermarket (or ATM) fairness distribution program, and was awarded $1.52 million in grant earnings from Walloon Area.
Along with capital financings, late within the first quarter of 2022, VolitionRx acquired a $10 million upfront charge from License and Provide Settlement with Heska Corp.
VolitionRx is engaged in a number of epigenetic initiatives primarily based on firm’s proprietary Nu.QTM platform, which encompasses quite a few blood-based medical assays which have been developed internally throughout the firm.
IP Portfolio
VolitionRx has a considerable IP portfolio with 84 granted patents, together with 12 within the U.S., 14 in Europe and an extra 58 worldwide as of December 31, 2021. The corporate has 93 patent purposes pending.
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