Evaxion announces business update and third quarter 2024 financial results
COPENHAGEN, Denmark, October 31, 2024 - Evaxion Biotech A/S (NASDAQ:EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, provides business update and announces third quarter 2024 financial results.
Business highlights (since last quarterly update)
Since the second quarter 2024 business update, we have continued to execute strongly on our strategy and plans with several major milestones achieved. Key highlights include:
Significant expansion of the infectious disease vaccine development collaboration with MSD (tradename of Merck & co., Inc., Rahway, NJ, USA) in a transformative deal for Evaxion
Continuously increasing external interest and several ongoing partnerships discussions covering both our platform and pipeline
Strong progress in clinical and preclinical development with convincing phase 2 data presented for personalized cancer vaccine EVX-01 and preclinical Proof-of-Concept obtained for EVX-B2 mRNA Gonorrhea vaccine candidate
Launch of improved AI-Immunology™ platform for vaccine antigen prediction
Thomas Schmidt appointed as interim Chief Financial Officer
"We continued to make solid progress on our strategy execution in a busy third quarter and are very pleased to have achieved several important milestones across our company. The MSD agreement, which holds the potential to transform Evaxion over the coming years, and the groundbreaking EVX-01 phase 2 efficacy data, stand out among our many achievements. We continue to demonstrate our strong capabilities as a truly AI-based TechBio company and remain focused on advancing on-going partnerships as well as new partnership discussions, progressing the EVX-01 trial and carrying through preclinical studies as a basis for expanding our R&D pipeline," says Christian Kanstrup, CEO of Evaxion.
2024 Milestones
Milestones
Target
EVX-B1
Conclusion of final MTA study with potential partner
Q1 2024 ✓
AI-Immunology™
Launch of EDEN™ model version 5.0
Mid 2024 (ECCB, September) ✓
EVX-B2-mRNA
EVX-B2-mRNA preclinical Proof-of-Concept obtained
Q3 2024 (18th Vaccine Congress, September) ✓
EVX-01
Phase 2 one-year readout
Q3 2024 (ESMO Congress, September) ✓
EVX-B3
Conclusion of target discovery and validation work in collaboration with MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA)*
H2 2024 (✓)
Precision ERV cancer vaccines
Preclinical Proof-of-Concept obtained
H2 2024
Funding
Ambition for full year 2024 is to generate business development income or cash in equal to 2024 cash burn (excluding financing activities) of $14 million**
* MSD option and license agreement on EVX-B2 and EVX-B3 supersedes this milestone** See update on the business development income ambition below
Research & Development update
We maintain a high activity level in Research & Development (R&D) from both a preclinical and clinical perspective. This work yielded outstanding results in the third quarter, first and foremost with the presentation of encouraging one-year data from the ongoing phase 2 trial with our lead asset EVX-01, an AI-Immunology™ designed personalized cancer vaccine, in patients with advanced melanoma (skin cancer).
The data demonstrates 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, an immunogenicity rate of 79%, and a positive correlation between our AI-Immunology™ platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). The observed immunogenicity rate means that 79% of EVX-01's vaccine targets triggered a targeted immune response, which compares very favorably to what is seen with other approaches.
These clinical findings underscore the significant therapeutic potential of EVX-01 and are yet another validation of the AI-Immunology™ platform as a leading AI technology for fast and effective vaccine target discovery and design.
We were also successful in our preclinical research, obtaining Proof-of-Concept for novel mRNA Gonorrhea vaccine candidate EVX-B2. This was based on new data documenting that EVX-B2 mRNA triggers a targeted immune response that leads to the elimination of the gonorrhea bacteria. The same had earlier been shown for the protein-based version of EVX-B2, which is now part of our partnership with MSD. The mRNA data has been generated as part of our partnership with Afrigen Biologics.
Further to our pipeline, our R&D investments are also allocated to the continued improvement of our AI-Immunology™ platform. During the third quarter, we updated the platform with the launch of a new version of its EDEN™ AI prediction model. Among other improvements, the model can now predict toxin antigens, allowing for the development of improved bacterial vaccines. We expect this update to further solidify the strong interest seen in AI-Immunology™ from potential partners.
Business development income
Our strategy is based upon a multi-partner approach, making effective execution upon our business development plans crucial to our success. We were thrilled to sign the significantly expanded vaccine development collaboration with MSD during the third quarter. Further, we continue to see an increasing interest from potential partners and are excited by the current partnership opportunities both around existing pipeline assets as well as our AI-Immunology™ platform.
The agreement with MSD carries potential business development income of up to $10 million for 2025 on top of the $3.2 million upfront payment received in 2024. Based upon the current business development opportunities, we remain confident in our ability to execute upon our multi-partner strategy and bring in significant business development income.
Given that certain partnership ...
