CEO Fernando Andreu comments:

“GOOD COMMERCIAL PROGRESS AND PRIORITIZATION OF NEW BUSINESS MODEL
In October we shared a major update on our strategy. The core shift involves concentrating all our efforts on bringing IndiTreat® testing to hospitals worldwide swiftly and fast-track the development of an automated In Vitro Diagnostic (IVD) system. This decision has been brewing for a while, and despite Q3 showing improved results with discussions initiated in 46 new hospitals, 26 patient samples received, and revenue of 885K SEK (10% from commercial sales), it also highlighted a significant challenge.

To position ourselves as global leaders in the emerging Functional Drug Sensitivity Testing market (expected to reach multi-billion USD per year), we need to shift our business model. The focus now is on enabling in-house testing at customer labs, providing instruments, reagents, consumables, and software globally.

This is not a new strategy as we have envisioned the transition of IndiTreat® from service to product since our foundation. We have partnered, developed prototypes, and internally created a proprietary consumable concept ("drug cartridge"). Our plan involves accelerating the system's "industrialization" to achieve usability, serviceability, reliability, and manufacturing scalability. We will engage a Contract Development and Manufacturing Organization (CDMO) for this and meanwhile, we will continue offering IndiTreat® as a service, pushing the IGNITE program and clinical studies to expand our user base. The development project, ZENITH, is detailed in the report.

We believe refocusing on the automated system is the right move to unlock the full potential of Functional Drug Sensitivity Testing, making 2cureX a global leader. The efforts in product development, market reach, and regulatory compliance converge in this crucial project. It is a pathway to a more scalable and profitable business, creating opportunities for partnerships and value creation, aligning with shareholder expectations and we are thankful for the continued support in this new phase.

With a cash reserve of 18.1 MSEK, ongoing activities are secure into Q2 2024. To further fuel growth, 2cureX is exploring diverse options, including funding instruments, partnerships, and M&A, while acknowledging shareholders' unwavering support.”

Third quarter of 2023 (2023-07-01 until 2023-09-30) – the group

Net turnover for the period was 87 KSEK (0 KSEK).
Other operating income was 798 KSEK (395 KSEK)
The result before tax was -10 164 KSEK (-8 353 KSEK)
The result per share* was -0.58 SEK (-0.47 SEK)
The solidity** was 83 % (93 %).
The cash and bank were 18 104 KSEK (47 820 KSEK).

*Earnings per share: Profit for the period divided by the average number of shares. Average number of shares in third quarter of 2023: 17 602 916 shares. Total number of shares in 2cureX AB on September 30st, 2023: 17 602 916 shares.
**Equity ratio: Shareholder’s equity divided by total capital.

Significant events during the third quarter 2023

July:

2cureX releases invitation for the Q2 2023 update and Q&A

August:

2cureX publishes the interim report for Q2 2023

2cureX launches its first two IndiTreat products CE-marked under the new IVD Regulation

October:

2cureX releases invitation for the Q3 2023 online presentation with a Q&A session

2cureX advances towards IVD-R compliance by securing a contract with a Notified Body

2cureX calls for an extraordinary General Meeting

2cureX releases a strategy update: Leapfrogging to the decentralization of IndiTreat testing through full focus on automation

2cureX participatd in the “Knæk Cancer” panel discussion

November:

2cureX and its IndiTreat Image Uploader gets IVD CE-Mark

2cureX releases the bulleting from the Extraordinary General Meeting