• Clinical validation study of INOVIQ’s SubB2M/CA15-3 test for breast cancer detection show ‘outstanding results’ 
  • A study using StarPharma technology put on hold, ‘won’t affect other programs or partnerships’ 
  • Advanced Health Intelligence faces NASDAQ delisting

INOVIQ soars 44% following clinical data for breast cancer test

Developer of next-generation exosome solutions and precision diagnostics INOVIQ (ASX:IIQ) has soared 44% in morning trade after announcing what it calls “excellent results” from an independent clinical validation study of its SubB2M/CA15-3 test for breast cancer detection.

The study showed high accuracy (87%), sensitivity (81%), and specificity (93%) for INOVIQ’s SubB2M test, outperforming a leading approved CA15-3 test.

“The outstanding results from this independent clinical validation study of our SubB2M breast cancer test represent a major milestone for INOVIQ,” CEO Dr Leearne Hinch said.

“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.

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

INOVIQ’s disruptive SubB2M technology is an engineered protein that detects the pan-cancer biomarker Neu5Gc, found in multiple human cancers.

SubB2M tests are designed to enhance the sensitivity, specificity and clinical utility of existing tumour marker tests routinely used for cancer detection and monitoring, such as CA15-3 for breast cancer, CA125 for ovarian cancer, PSA for prostate cancer and CA19.9 for pancreatic cancer.


Trial using Starpharma tech put on hold

Meanhwile, Starpharma (ASX:SPL) has dropped more than 6% today after announcing a voluntary partial clinical hold has been implemented on a trial in which its technology is used.

The Phase 1/2 study titled AZD0466 Monotherapy or in Combination in Patients with Advanced Haematological Malignancies (NCT04865419) is in the dose escalation phase.

SPL said the asymptomatic reported events leading to the voluntary partial hold were assessed as not related to its DEP dendrimer.

The company said the voluntary partial clinical hold does not impact its platform technology, or other clinical DEP programs or partnerships.

The other clinical study of AZD0466 in patients with non-Hodgkin’s lymphoma (NCT05205161) is not impacted and continues to enrol patients.

SPL said it will provide further details to the market when additional relevant information becomes available.


Advance Health Intelligence facing NASDAQ delisting

Dual-listed Advanced Health Intelligence (ASX:AHI)  has dropped more than 15% today after announcing it is looking down the barrel of a NASDAQ delisting.

It seems a little complex but in June 2022 AHI received a deficiency notification letter from NASDAQ listing qualifications staff indicating it was not in compliance with listing Rule 5550(a)(2) because the bid price for the company’s American Depositary Shares (ADSs) had closed below $1/share for the previous 33 consecutive business days.

In accordance with another NASDAQ Listing Rule 5810(c)(3)(A) AHI was provided 180 calendar days until December 21, 2022, to regain compliance with the minimum bid price requirement.

On December 22, 2022, AHI received notification from NASDAQ granting it a further 180 days, or until June 19, 2023, to regain compliance, following an application for extension.

According to the latest announcement on June 20, 2023, AHI received a determination letter from NASDAQ stating that the company has not regained compliance with the rule and as a result its securities will be delisted from the bourse and trading of its securities suspended at the opening of business on June 29, 2023.

However, all is not lost and AHI has appealed NASDAQ’s determination to a hearings panel, which it can do under more listing rules. The hearing is scheduled for August 17, 2023.

AHI said accordingly, the delisting action referenced in NASDAQ’s determination letter has been stayed, pending a final written decision by the panel, meaning it can keep trading.

And the company has a plan to present to the panel to regain compliance with the bid price rule. AHI said it intends to take the necessary steps to immediately effect a ratio change of the ADSs to its non-traded ordinary shares from the current ratio of one ADS representing seven ordinary shares to a new ratio which will have the same effect as a reverse split of the existing ADSs.

Once the ratio change has taken effect, the ADSs must trade at or above $1 for 10 consecutive business days for AHI to regain compliance.

AHI said NASDAQ’s written notice doesn’t affect the listing or trading of its common stock at this time.  The AHI share price has fallen more than 94% on both the ASX and NASDAQ over the past year.


Sonic to buy  SYNLAB Group for ~$250 million

Sonic Healthcare (ASX:SHL) has announced it has signed a binding agreements to acquire SYNLAB Suisse SA, the Swiss laboratory network of SYNLAB Group for CHF150 million  (~A$250 million).

The purchase follows a strategic decision of the SYNLAB Group to divest its Swiss operations. SHL said SYNLAB Suisse is expected to generate annual revenues of CHF100 million and employs around 600 staff across 19 laboratories.

It is one of the few laboratory groups with coverage of all three Swiss language regions and provides services to GP, specialist and hospital clients across the full range of routine and specialty laboratory medicine, including anatomical pathology and human genetics.

The integration of SYNLAB Suisse with SHL will be led by SHL’s existing Swiss leadership team together with the management team of SYNLAB Suisse.

The purchase price of ~$250 million will be funded in Swiss francs from Sonic’s existing cash and debt facilities.

SHL said the transaction will be earnings per share (EPS) accretive from CY24 and the return on invested capital (ROIC) will exceed its cost of capital within two years of acquisition.

Swiss merger control clearance has been obtained and the transaction is expected to close on  July 3, 2023.


Immutep completes underwritten retail entitlement

Immutep (ASX:IMM) has announced a fully underwritten placement to institutional investors and a 1 for 7.6 pro rata accelerated non-renounceable entitlement offer of new fully paid ordinary shares to raise ~$80 million.

IMM said the placement and institutional component of the entitlement offer were successfully completed, raising ~$67.9 million.

The retail entitlement offer allowed eligible retail shareholders in IMM to subscribe for one new share for every 7.6 existing fully paid ordinary shares which they held at 7pm (AES) on  June 2, 2023 at a price of 26 cents/new share, and also the opportunity to apply for additional new shares in excess of their entitlement.

IMM said the retail entitlement offer closed at 5pm (AEST) on June 23, 2023 and a total of 2,009 valid applications for retail entitlements were received raising approximately ~$4.7 million.

Eligible retail shareholders also applied for and were allocated a further ~$1.8 million of additional new shares.

Total eligible applications under the Rretail entitlement offer of approximately $6.5 million represents a total take-up rate by eligible retail shareholders of 52.9%.

Together with the placement and the institutional component of the entitlement Offer, the total amount raised under the offer, which was fully underwritten, is ~$80 million.


The IIQ, SPL, AHL, SHL & IMM share price today: