Follow on from the breast cancer test results there has been online speculation that the ovarian cancer test results are about to drop. This announcement could be the precursor as Promega colab is needed to produce a lab test.

INOVIQ and Promega sign a global joint marketing agreement for INOVIQ’s EXO-NET® exosome capture technology and Promega Nucleic Acid purification systems

• Initial deal enables co-marketing of both INOVIQ and Promega products to deliver exosome solutions to global customers for manual and high-throughput exosome isolation and nucleic acid extraction

• Agreement expected to deliver world-class exosome tools and technologies to researchers, pharma and clinical laboratories globally to enable their exosome isolation, biomarker discovery and diagnostics needs in a market expected to reach US$8.7b by 2029

A HT EXO-NET solution was critical to the ongoing development and clinical validation of INOVIQ’s exosome-based Ovarian Cancer Test. This blood test has the potential to aid in earlier detection of ovarian cancer, when it can be cured and help save women’s lives. Our new HT EXO-NET solution truly enables the development and commercialisation of exosome-based diagnostics in clinical laboratories worldwide.”

IIQ SP up 40% on clinical validation of the breast cancer blood test. Commercial discussions mentioned but a long way to go for full commercial use. More detail in an investor briefing on Thursday. INOVIQ reports outstanding results from 483 sample SubB2M breast cancer study

• INOVIQ’s SubB2M/CA15-3 breast cancer test detected all-stages of breast cancer with excellent accuracy (87%), sensitivity (81%) and specificity (93%) 
• The results of the comprehensive 483-sample, case-control study established that INOVIQ's SubB2M/CA15-3 blood test significantly outperformed a leading approved test, routinely used for monitoring of breast cancer. It demonstrated an area under the curve (AUC) of 0.93 compared to 0.70 
• INOVIQ is finalizing its planned breast cancer monitoring study and advancing discussions with potential partners and Key Opinion Leaders (KOL’s) for its SubB2M platform and tests

Commenting on the data, CEO, Dr Leearne Hinch said: “The outstanding results from this independent clinical validation study of our SubB2M breast cancer test represent a major milestone for INOVIQ. Our SubB2M/CA15-3 blood test detected all-stages of breast cancer with 81% sensitivity and 93% specificity, outperforming a leading CA15-3 test. These positive results support the commercial potential of our simple, cost-effective SubB2M/CA15-3 test for screening and monitoring of breast cancer.  

INOVIQ intends to present these data and our development plans to potential partners and KOLs to advance commercial discussions for its SubB2M/CA15-3, SubB2M/CA125 and SubB2M multi-cancer tests.” 

You are invited to join us for an investor briefing this week, where Leearne and CSO, Dr Greg Rice will talk to the data in detail. Access details are outlined below: 

Date: Thursday 29 June 2023

Time: 11:00am AEST 

Register via the following link: https://us02web.zoom.us/webinar/register/WN_etcraaRmT-i0s2NJmpSZWw 

Disc: Held in SM and RL

Broker report commissioned by IIQ. "We value IIQ at A$195m or A$2.11 per share (undiluted), using a risk-adjusted net present value (rNPV) method to discount future cash flows through to 2043, consistent with the expiry life of patent families. "

No projection of +ve cashflow up to CY24. A long term hold for me in RL and SM

Positive news on the UQ trial with 92% detection of early stage Ovarian cancer using the Exo-net technology in plasma samples has given the SP a welcome boost.

Disc held in RL and SM

EXO-NET® feasibility study completed by The University of Queensland, confirms the utility of EXO-NET for isolating Extracellular Vesicle (EV) biomarkers and development of an EV-based ovarian cancer screening test

• Data from 97 plasma samples (ovarian cancer, benign and healthy controls) identified highly significant differences between the EV biomarker content of ovarian cancer and control samples

• A multivariate algorithm using selected EV biomarkers achieved 92% accuracy for detection of early-stage ovarian cancers in an independent sample set

• Next step is an analytical validation study to establish equivalence of the EV-based ovarian cancer test in plasma compared to serum from the same cohort of patients

• INOVIQ holds the exclusive Option to license rights to the development and commercialisation of the EV-based ovarian cancer test to improve women’s health outcomes and help save lives

Legal proceedings finally settled. Deal seems reasonable and still retains some potential revenue if the lung cancer test is developed. Should allow the Breast and Ovarian cancer test development to proceed.

INOVIQ has settled the legal proceeding related to the BARD1 performance shares

Plaintiffs to receive BARD1 Lung Cancer Test IP and $1 million payment. INOVIQ retains Breast and Ovarian Cancer IP and receives 10% of future sales of BARD1 Lung Cancer Test until the expiry of relevant patents, and 5% thereafter

Legal Proceeding by Plaintiffs will be dismissed in accordance with agreed Court orders and no costs awarded

INOVIQ will transfer its shareholding in BARD1AG SA to the Plaintiffs. BARD1AG SA is the entity that holds rights in relation to the intellectual property (IP) associated with the BARD1 Lung Cancer Test (LCT), namely the licence in patent WO/2012/023112 entitled 'Bard1 Isoforms In Lung And Colorectal Cancer and Use Thereof' and ownership of the patent WO/2015/067666 entitled 'Lung Cancer Diagnosis' (the LCT IP);

INOVIQ will retain through a separate agreement with BARD1AG an entitlement to (among other things) 10% of the net sales of any products developed using the LCT IP for the duration of the patents, and then 5% upon expiry of both patents;

INOVIQ will pay the Plaintiffs a lump-sum payment of A$1 million (inclusive of GST) and the Plaintiffs have an obligation to commit $300,000 to the development of the LCT over the next 2 years; and

Good to see IIQ moving towards a commercial application of the SubB2M technology. Providing the test on a high throughput platform with up to 200 times less sample and minimal hands‐ on time as a cancer screen could lead to broad use.

“The project aims to demonstrate effective discrimination between cancer and cancer‐free blood samples on the Alto instrument. INOVIQ will pay (non‐ material) agreed costs for the work undertaken and the project is expected to complete within six months from commencement date.

On successful completion, INOVIQ will need to conduct additional studies to further develop and validate the SubB2M‐based SPR test for risk assessment of multiple cancers. Additionally, INOVIQ and Nicoya intend to enter a commercial arrangement enabling INOVIQ to commercialise the SubB2M‐based SPR test on the Alto instrument for detection and monitoring of multiple cancers.”

Contract signed with Nicoya to transfer, develop and evaluate a SubB2M-based Surface Plasmon Resonance (SPR) test on the AltoTM Digital SPR instrument

• Nicoya has commercialised Alto, a next-generation benchtop SPR instrument for the highly sensitive detection of analytes such as proteins, antibodies, nucleic acids and sugars

• Nicoya’s Alto has the potential to deliver in vitro diagnostic tests for use in pathology laboratories worldwide

• The SubB2M-based SPR test measures Neu5Gc levels and will initially be developed for use as a cancer risk assessment test

Held in RL and SM

https://iiq2.live.irmau.com/site/pdf/c0b97281-08e1-4c18-ba56-30a392911568/INOVIQ-to-Develop-SubB2MBased-Test-on-Nicoya-SPR-Platform.pdf

IIQ announces results of a SubB2M further use feasibility study for detecting melanoma in tissue samples

POSITIVE SUBB2M IHC RESULTS FOR MELANOMA

Immunohistochemistry (IHC) feasibility study successfully completed using INOVIQ’s SubB2M probe to aid in diagnosis of malignant melanoma in tissue samples

Data from 144 tissue samplesin thisfeasibility study demonstrated that SubB2M IHC detected melanoma with 91% sensitivity and discriminated between malignant melanoma and benign skin lesions

INOVIQ’s SubB2M technology detects the pan‐cancer biomarker Neu5Gc that is found at elevated levels in multiple human cancers

SubB2M‐based IHC applications represent a new product opportunity for SubB2M as an IHC reagent in the $1.9b IHC market

INOVIQ to seek partners to sublicence the further development and commercialisation of SubB2M IHC tissue‐based tests

The skin cancer diagnostics market size is expected to be worth US$5.8b by 2028, with the melanoma segment representing US$2b. In 2020, an estimated 324,635 people were diagnosed with melanoma globally and an estimated 57,043 people worldwide died from melanoma in the same year

CSO Dr Gregory Rice said: “The results obtained in this feasibility study support further optimization and validation of SubB2M as an IHC reagent, particularly as an aid in the diagnosis of malignant melanoma.  Importantly, the detection of Neu5Gc in these cancer tissues is consistent with its role as a pan‐cancer biomarker and further supports the development of INOVIQ’s SubB2M‐based blood tests for breast and ovarian cancers.”

IIQ contracts out sales and logistics for EXO_NET roll out (no details of cost) and is granted an extension patent to expand IP coverage for hTERT tech.

INOVIQ engages US-based Percorso Life Sciences to provide contract sales force and logistics services to accelerate commercial roll-out of EXO-NET® products in the USA

Contract sales force covers the key East-Coast, West-Coast and Mid-West US regions

Services include marketing, sales, inventory, logistics and warehousing of EXO-NET research tools to academia and biopharma customers

Engagement in line with INOVIQ’s strategy to first commercialise EXO-NET as a research tool in the global exosome research market, which is expected to reach US$661 million by 2026, with US representing 41.5% of market

US Patent granted covering the hTERT technology. Provides further IP protection for hTERT in the USA for cancer applications beyond bladder cancer due to expire on 11 March 2035 and claims use of the Company’stelomerase antibody to resolve inconclusive cytology and detect malignant cells.   

CEO Dr Leearne Hinch said: “This application is a continuation of US patent 10,338,072 and provides additional coverage of our hTERT assay for telomerase‐based detection of cancers other than bladder cancer, such as thyroid and breast cancer.” The hTERT test is an immunocytochemistry (ICC) assay that detects hTERT, a component of telomerase, which is upregulated in most human epithelial cancers. The present test is used as an adjunct to urine cytology, assisting in the diagnosis of bladder cancer.

Little cash incoming but plenty in bank. Progress towards commercial cancer tests. Exo-Net research commercialisation progressing.

Operating cash receipts during the quarter included:

$141k from the Biomedical Translation Bridge (BTB) grant program supporting the development of SubB2M-based liquid biopsy tests to detect and monitor breast cancer (YTD $168k);

$30k from the Export Market Development Grant (EMDG) program;

$16k in bank interest (YTD $27k);

No receipts from customers were recorded during the quarter (YTD $221k). As discussed in section 1.1, receipts will be recorded during the June 2022 quarter for orders received in February, March, and April.

Net cash used in operating activities for the quarter was $1.3m (YTD $4.9m) with the main expenses being:

Research and Development (R&D) expenditure of $592k (YTD $2.1m);

Non-R&D staff costs of $363k (YTD $1.3m);  Administration and corporate costs of $322k (YTD $1.5m); and

Patent fees of $127k (YTD $295k)

INOVIQ has executed a Master Manufacturing Agreement with MP Biomedicals for production of the SubB2M protein for the Company’s SubB2M-based tests

Agreement with MP Biomedicals enables production of cGMP protein for commercial SubB2M tests and represents a key milestone for INOVIQ 

FUTURE MILESTONES

Report SubB2M IHC data for cancer

Progress EXO-NET collaborations in Australia and internationally with leading research institutes

Publication of EXO-NET data (product comparison)

Appoint US sales force/distribution partner for EXO-NET

Progress development of new EXO-NET products for use in additional disease indications and clinical trials

Progress UQ collaboration for exosome-based ovarian cancer screening test

Commence SubB2M clinical studies for breast cancer and ovarian cancer 

IIQ has fallen out of favour with investors and even a couple of positive announcements haven’t stopped the decline. Progress on development of the SubB2M tests and use of the EXO-NET® technology in developing another ovarian cancer test with an option to license the tech from UQ.

INOVIQ’s SubB2M technology detects the pan-cancer biomarker Neu5Gc found at elevated levels in multiple human cancers

SubB2M-based tests are in early development for multiple uses including monitoring of breast and ovarian cancers, and for a general health panel

ResearchDx, a US-based specialty contract diagnostics organisation, will undertake further development and validation of SubB2M-based tests

Key milestones met to transfer SubB2M-based tests to an accredited CRO for commercial development and also for a potential LDT laboratory partner in the USA

INOVIQ and The University of Queensland (UQ) expand collaboration to develop a world-first exosome-based ovarian cancer screening test

UQ to develop exosome-based blood test for the earlier detection of ovarian cancer under a $2.7m Medical Research Future Fund (MRFF) grant

INOVIQ to provide its EXO-NET® technology for fast, accurate and scalable exosome isolation in thousands of blood samples

INOVIQ has the exclusive option to license rights to the development and commercialisation of UQ’s exosome-based early detection test for ovarian cancer to improve women’s health outcomes and help save lives,

Held in RL

Further protection of IP : Brazilian patent granted covering use of BARD1 isoforms in lung and colorectal cancer

Protects a BARD1 autoantibody test for detection of lung or colorectal cancer

This BARD1 patent family now has thirteen granted patents enforcing protection in Australia, Canada, China, Europe, Hong Kong, Israel, Japan, Singapore and the USA.

Disappointing that the hTERT sales have gone to zero. Legal case still ongoing. Research ongoing. Have to think this will be sold down. I still think the technology has good potential but with no revenue in the near term need to think about opportunity cost.

“ The COVID-19 Omicron variant has continued to reduce routine pathology testing and is a key factor leading to nil receipts for hTERT during the quarter ended December 2021. Previous hTERT receipts were $221k in the September 2021 quarter and $152k in the December 2020 quarter.

Our US distributor, StatLab, placed multiple orders in the June 2021 quarter in anticipation of an uplift in sales during the half-year to December 2021. However, hTERT sales remained flat due to the continuing COVID-19 epidemic, resulting in existing US laboratory customers being supplied from StatLab inventory. Sales of the hTERT test are expected to remain flat until the pandemic abates.

The Walker and Irminger legal proceedings against the Company remain before the Supreme Court.The discovery process is substantially completed and the Company continues to defend the matter. No further comments can be made in relation to the proceedings at this time.

Important protection of IP

US PATENT ISSUED PROTECTING BARD1 TECHNOLOGY FOR BREAST AND OVARIAN CANCER DIAGNOSIS

? US patent granted covering breast and ovarian cancer diagnosis

? Protects BARD1 autoantibody tests for detection of breast and ovarian cancer

Melbourne, Australia, 17 January 2022: INOVIQ Limited (ASX:IIQ) (INOVIQ or the Company) is pleased to announce that US Patent 11,193,944 titled ‘Kits for detecting breast or ovarian cancer in a body fluid sample and use thereof’ was issued by the United States Patent and Trademark Office (USPTO).

The issued US Patent 11,193,944 is a continuation of US 10,018,639 with additional claims directed towards a method for detecting BARD1 autoantibodies associated with breast or ovarian cancer in body fluids and related assays, kits and peptides. The patent application was filed by INOVIQ Ltd (previously BARD1 Life Sciences Limited) on 13 June 2018 and is due to expire on 28 November 2032.

CEO Dr Leearne Hinch said: “There is an important unmet medical need for non-invasive, accurate and reliable tests for earlier detection and monitoring of breast and ovarian cancers to improve women’s health outcomes. This patent provides IP protection for potential BARD1 autoantibody tests for detection of breast and ovarian cancer in the USA.”

This BARD1 patent family now has three granted patents enforcing protection in the key US and European markets.

Don’t think this’ll do anything to arrest the slump in the share price. Wonder how much it costs to redo all the marketing materials and stationery?

 BARD1 CHANGES ITS NAME TO INOVIQ

• New code ASX:IIQ from 9 December 2021

• INOVIQ represents ‘intelligent innovation’ as the Company builds an innovative portfolio of diagnostic and exosome-based products

BD1 had a +40% day today but at 1.40 is still a long way from its $5 peak. A US patent and presentation on their exosome technology is the recent news.

US PATENT ISSUED IN BARD1 PATENT FAMILY FOR LUNG CANCER DIAGNOSIS

• US Patent No 11137402 granted covering lung cancer diagnosis

• Protects a BARD1 autoantibody test for diagnosis of lung cancer in key US market

EXO-NET is either equivalent to or out-performs all competitor products tested. In addition it is faster, and scalable for high throughput applications

Simple, rapid procedure for intact exosome isolation, limited hands-on time and incubation time of 15 minutes.

• Protein and nucleic acid extraction possible from the same sample.

• Recovery of miRNA and mRNA is equivalent or substantially improved compared to other commercial products.

• Compatible with high through-put instrumentation.

• Uniquely flexible permitting isolation of a broad population of exosomes (EXO-NET) and customization for highly specific and selective isolation of sub-populations.

BD1 making steady progress but still a long way from FCF. Legal proceedings ongoing.

Biggest opportunity for value for SH is in a buyout or JV arising from commercialisation of cancer tests where specificity and selectivity of their technology is market leading compared to competitors. See linked diagrams from HC

https://hotcopper.com.au/attachments/image-png.3551379/?temp_hash=04eac4fc4e4e0709ef3345b39a6352ef

https://hotcopper.com.au/attachments/image-png.3551462/?temp_hash=04eac4fc4e4e0709ef3345b39a6352ef

https://hotcopper.com.au/attachments/image-png.3551456/?temp_hash=04eac4fc4e4e0709ef3345b39a6352ef

FINANCIAL RESULTS

The Group report an unaudited net loss of $12,367,119 (2020: $3,253,553 loss). It should be noted that the comparative period is based on financial results of the entity prior to the merger with Sienna.

The net loss includes the recognition of a non-cash intangible asset impairment loss of $7,321,047 (2020: $Nil).

Income from other sources was $1,003,957 (2020: $633,486) including receipt of $643,542 from the Research and Development Tax Incentive Refund (2020: $464,101) for the 2020 financial year, grant income of $317,533 (2020: $71,000) and interest and miscellaneous income of $42,882 (2020: $98,385).

Sales of the hTERT test were negatively impacted by COVID-19 during the year with revenues of $468,096 achieved post-acquisition (2020: $0). This hTERT revenue excluded pre-acquisition sales of $81,052 in July 2020, and $60,000 of the $80,000 first order received from South Korea as only part of the order was shipped before balance date. Inclusion of the additional $141,052 would bring the full year sales to $609,148 for FY2021, a 29% increase in sales when compared the revenue reported by Sienna for FY2020, $472,809.

The Group’s reported total operating expenditures, other than impairment of intangible assets, were $8,092,828 (2020: $3,887,039). Research and Development expenses were $1,594,056 (2020: $515,339) on the BARD1, SubB2M and NETs programs. 

Patent expenses of $112,077 (2020: $169,558) were incurred on intellectual property maintenance.

The merger with Sienna and refocus of resources led to BD1’s workforce expanding to 15 employees, including 11 residing in Australia and 4 based in the US by year end. The increased headcount from the merger resulted in a higher employee expense of $3,185,127 (2020: $1,223,252).

The loss was reduced by the recognition of a $1,638,748 tax credit cash balance of $4,998,564 (2020: $7,326,861). This has subsequently increased following the $18.4 million placement and SPP

Diagnostics pipeline commercialisation

To support the commercialisation of the Company’s diagnostic pipeline, BD1 continues to progress discussions with potential laboratory partners to develop and validate the SubB2M-based assays in-house as laboratory developed tests (LDTs) in the US. 

The Company also continues to engage with clinical, regulatory and health economic experts to further define and progress its clinical development, regulatory and reimbursement strategies for its multi-product diagnostic pipeline for breast, ovarian, prostate, and other cancers.

The commercialisation strategy for the Company’s diagnostic pipeline is to first launch the tests as LDTs, followed by an FDA3 In Vitro Diagnostic (IVD) submission and clinical studies to support 510k clearance4 or PMA5 approval depending on the indication for use. 

These discussions are ongoing as the Company advances its diagnostic development programs towards clinical development and commercialisation.

On 17 August 2021, BD1 announced that proof-of-concept (POC) had been achieved for its SubB2M/CA125 enzyme-linked immunosorbent assay (ELISA)-based test. Importantly, achievement of this POC milestone supports and de-risks further development of SubB2M ELISA-based tests for ovarian, breast, prostate, and other cancers.

BD1 also achieved a successful ethics committee application during the year for the supply of samples from patients with breast, ovarian, prostate, and pancreatic cancers from the Victorian Cancer Biobank. These samples are critical for fast- tracking further development and validation of our SubB2M-based tests for breast, ovarian, prostate, and pancreatic cancers.

NET’s program

The Group also initiated and progressed development of customised EXO-NETs for use in the manufacturing of exosomes for therapeutic applications. Discussions were advanced with Australian-based therapeutic exosome groups to supply the modified EXO-NET prototype for initial evaluation in their proprietary therapeutic exosome manufacturing process.

OUTLOOK AND PLANS

financial year 2022 plans include:

• Feasibility results for SubB2M-ELISA tests,

• Advance clinical testing for SubB2M-based breast and ovarian cancer tests,

• Finalise contract manufacturing agreements for reagents,

• Secure laboratory partner/s for commercialisation of diagnostic pipeline,

• Appoint distribution partner/s for RUO EXO-NET®,

• Expand development and licensing opportunities for EXO-NET® products, and

• Advance other research programs including BARD1.

SPP successfully completed with oversubscribed applications of $3.4m accepted
• Total capital raised of $18.4m under both the SPP and recent placement to institutional and sophisticated investors
• BARD1 is now well funded with a pro forma cash balance of approximately $22.0m to advance its diagnostic programs towards key development and commercialisation milestones over the next 2 years
Melbourne, Australia, 23 August 2021: BARD1 Life Sciences Limited (ASX:BD1) (BARD1 or the Company) is pleased to announce that it has successfully completed the Share Purchase Plan (SPP) announced on 23 July 2021, with applications accepted for $3.4 million, including oversubscriptions. The Company was seeking to raise up to $2.0 million through the SPP. However, given the strong support for the SPP by eligible shareholders, the BARD1 Board has exercised its discretion to accept $3.4 million.

Good to see a company allowing retail investors to get what they wanted.

I think there is a good mix going forward

Dr Geoffrey Cumming, BARD1 Chairman added: "BARD1 is now well positioned to build a sustainable diagnostics business with a diversified portfolio of proprietary technologies, commercialised products and cancer diagnostics pipeline with the potential to deliver real benefits to patients, clinicians, payors and shareholders."