WntResearch

The Phase 2 clinical study NeoFox aimed to establish proof-of-concept for the drug candidate Foxy-5 for the treatment of colon cancer. The study included a total of 27 patients before it was stopped, including 16 patients on Foxy-5, and 11 patients in the control group, as previously announced. The initial result reading showed a favorable safety profile for Foxy-5, but without significant clinical benefit.

The reason for the early analysis was to support the continued funding of the NeoFox study. However, no clinically relevant effects were seen on any of the study's crucial endpoints, which could be assessed in 15 out of 16 Foxy-5 patients, neither at half dose (n=3) nor at full dose (n=12). These endpoints were analyzed by CT scanning and included assessment of tumor size, as well as the number and size of lymph nodes, before and after treatment with Foxy-5. The exploratory endpoints included vascular and perineural invasion and were evaluated by tissue analysis of the surgically removed cancer tissue. In these analyses, the two groups are compared with each other. However, the number of patients who could be evaluated in each group was so limited (7 controls, 10 patients with full dose Foxy-5 and 3 patients with half dose Foxy-5) that it is impossible to draw any conclusiongs from the exploratory endpoints.

To justify continued investments in the development of Foxy-5 for this indication, it would have been necessary to demonstrate large effects by CT already at this initial evaluation. The Company is of the view that the results achieved significantly reduce the possibility to raise additional money via future option programs or to attract a partner who would be willing to finance the extensive development program that wouldbe necessary for taking the drug canditade towards a future market approval. As a result, WntResearch decided to discontinue the study and has started to reduce the cost base and to safeguard the values that remain in the company. Discussions are ongoing with other companies regarding the possibility of carrying out a merger, reverse acquisition or similar. In parallel, the Board of Directors and management of WntResearch are also evaluating opportunities to realize the remaining value of the drug substance and the patent portfolio, and broadening the scope to pharmaceutical companies interested in the WNT signaling pathway both inside and outside oncology.

"Foxy-5 is based on groundbreaking research that has attracted extensive international attention. The results we have seen so far from the NeoFox study show that the drug candidate has a good safety profile. However, it is disappointing that, despite the promising ad hoc observations previously communicated, we have not succeeded in documenting a sufficiently clear effect of Foxy-5 to make the drug candidate commercially attractive as a neoadjuvant treatment for colon cancer. We have been completely dependent on positive results in this initial analysis to be able to raise money in the upcoming option program. With the results we are now seeing, we do not believe that it is reasonable to raise additional money for the study. It is possible that a different study design would provide better opportunities to demonstrate more pronounced effects, but this would require significantly greater financial resources than a small company like WntResearch is able to raise in the current financial climate.", says Christer Nordstedt, Chairman of the Board of WntResearch.

"In the discussions we have had with potential partners, it has been clear that strong effects on tumor size and lymph nodes would be a prerequisite for their interest in financing the continued development of the drug candidate. The study was stopped as a consequence of the fact that such effects could not be observed. Instead, we are focusing on safeguarding the remaining value in the company and have, among other things, initiated discussions with a number of external parties who have shown interest in mergers or reverse acquisitions. In parallel, we are also evaluating opportunities to secure values related to Foxy-5 and the extensive patent portfolio.", says WntResearch's CEO, Per Norlén.

WntResearch will keep its stakeholders updated on the progress of the ongoing strategic work aimed at best safeguarding the remaining values of the company.

For further information:

Per Norlen CEO
E-post: per.norlen@wntresearch.com

About WntResearch

WntResearch is a biotech company in oncology that develops new therapies to counteract the development of cancer metastases. The company's research is focused on studying the endogenous protein WNT5A, which in scientific studies has been shown to affect the ability of tumor cells to move and spread in the body. WntResearch's drug candidate Foxy-5 is a peptide that mimics the function of WNT5A with the aim of reducing the motility and spread of cancer cells and thereby preventing metastases from occurring. Although today's cancer treatment has become more effective, there are no effective ways to prevent the onset of metastases that cause about 90 percent of all cancer-related deaths. Foxy-5 has a unique mechanism of action and has demonstrated a good safety profile with few side effects in two clinical phase I studies.

WntResearch is headquartered in Malmö and the company is listed on the Spotlight Stock Market.
For more information see: www.wntresearch.com