Vitrafy Reports $22.8m Cash, $3m Quarterly Burn, and Strategic IMV Partnership

• Exclusive 12-month strategic agreement with IMV Technologies for animal reproduction cryopreservation
• First Guardion device arrives in North America, supporting commercial launch
• Progress in U.S. Military phase II blood platelet cryopreservation testing
• Board leadership changes with new Chair and Independent Non-Executive Director
• Strong cash position of $22.8 million with approximately eight quarters of funding

Strategic Partnership with IMV Technologies

Vitrafy Life Sciences has taken a major step forward in its animal health segment by entering into an exclusive 12-month strategic commercial agreement with IMV Technologies, a global leader in animal-assisted reproduction. This collaboration aims to co-develop a market-ready cryopreservation solution that leverages the strengths of both companies to set new standards in preserving reproductive biological materials for farm animals and aquaculture. The deal includes recurring monthly payments and milestone incentives totaling up to nearly A$1 million, with potential for extension and a longer-term commercial relationship.

North American Commercial Launch and Expansion

On the human health front, Vitrafy has made a significant commercial leap with the arrival of its first Guardion device in California, marking the beginning of its North American market launch. The company has also established a California office co-located with Planet Innovation’s Irvine facility, facilitating customer demonstrations, training, and accelerating market entry. This presence is critical as Vitrafy targets the blood and cell & gene therapy sectors, where demand for advanced cryopreservation solutions is growing.

Advancing Clinical Trials and Regulatory Pathways

Vitrafy’s collaboration with the U.S. Army Institute of Surgical Research has resumed following a government shutdown, progressing phase II testing for blood platelet cryopreservation. Initial data readouts are expected in the next quarter, generating industry interest. Concurrently, the company has initiated the FDA medical device clearance process, aiming for Class II registration in the first half of FY2027. Achieving this regulatory milestone would significantly broaden commercial opportunities in human health markets.

Governance and Financial Position

The company’s governance has been refreshed with Dr Leigh Farrell assuming the Chair role and the appointment of Dr Jeannette Joughin as an independent Non-Executive Director, bringing valuable expertise in the North American blood market. Financially, Vitrafy ended the quarter with $22.8 million in cash and term deposits, despite a net cash outflow of $3.0 million. The company maintains a healthy runway with approximately eight quarters of funding based on current cash burn, supporting ongoing commercial and regulatory investments.

Outlook and Upcoming Milestones

Looking ahead, Vitrafy plans to ramp up production of Guardion units to meet anticipated demand and continue its commercialisation efforts in North America. Activities under the IMV agreement are set to commence shortly, while the company prepares to showcase its technology at the Phacilitate conference, a key event in the cell and gene therapy space. Investors will be watching closely for the half-year results release scheduled for early February, which will provide further insights into the company’s progress and financial health.

Bottom Line?

Vitrafy’s strategic partnerships and North American expansion position it well for growth, but FDA clearance and milestone achievements will be critical next steps.

Questions in the middle?

• Will Vitrafy secure FDA Class II medical device clearance on schedule in 1H FY2027?
• How quickly will the IMV Technologies collaboration translate into long-term commercial revenue?
• What impact will initial phase II blood platelet data have on market adoption and partnerships?