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Evaxion Announces Business Update and Third Quarter 2023 Financial Results Christian Kanstrup joined Evaxion as Chief Executive Officer in September Evaxion has launched its refined strategy with an increased focus on va

Key Takeaway: Evaxion Biotech A/S has provided a business update and reported its third quarter 2023 financial results, revealing cash and cash equivalents of $2.6 million. The company has priced a bridge financing round expected to raise approximately $5.3 million, aimed at funding operations into early 2024. Under new CEO Christian Kanstrup, Evaxion is focusing on its AI-Immunology platform, highlighting recent successful partnerships and encouraging Phase 2 data for its personalized cancer vaccine candidate EVX-01, although the company anticipates a significant cash burn in the upcoming year.

Market Sentiment Analysis

POSITIVE FACTORS

  • Evaxion has launched a refined strategy focusing on execution and value realization.
  • The recent bridge financing round, led by MSD Global Health Innovation Fund, demonstrates strong investor confidence.
  • Progress in partnerships and positive Phase 2 data for personalized cancer vaccines are promising developments.

CONCERNS & RISKS

  • The company anticipates a cash burn of $14 million for 2024, indicating potential financial pressures.
  • The reduced focus on Evaxion-driven clinical trials may impact new drug development timelines.

Full Press Release Details

Evaxion Announces Business Update and Third
Quarter 2023 Financial Results
Cash and cash equivalents of $2.6 million on September 30, 2023. On December 18, 2023, Evaxion priced a bridge financing round, expected to raise aggregate proceeds of approximately $5.3 million. This private placement is expected to close on or around December 21, 2023, and will fund operations towards the end of March 2024, marking an important step in Evaxion's long-term funding strategy
The ambition is to fund 2024 cash burn, excluding financing activities, with income from business development activities. Cash burn for 2024, excluding financing activities, is expected at the level of $14 million (with Q1 cash burn being significantly higher than other quarters in 2024)
Denmark, December 19, 2023 (GLOBE NEWSWIRE) - Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"),
a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, today provided a business update and
announced its third quarter 2023 financial results.
Christian Kanstrup, Evaxion's CEO, report,
"It has been a great pleasure to join Evaxion, and the first three months have confirmed my belief in a world-class organization
and business with strong potential for addressing significant unmet needs within cancer and infectious diseases. Our AI-Immunology
platform offers unique opportunities in this connection. A key focus for the first months has been to refine the Evaxion strategy with
a strong focus on execution and value realization.
I am pleased to be able to share the refined strategy
in a simple, straightforward overview below. The core of our strategy lies in our pioneering AI-Immunology platform, which has
been continuously refined and validated over the past many years. This platform holds the potential for generating one new target every
24 hours, is delivery modality agnostic, and is easily adaptable to partner needs. Based on the unique multi-disciplinary capabilities
built around our different AI prediction models, we focus on value realization via Targets, Pipeline and Responders. We have already
seen substantial progress within each of these three areas: Two partnerships announced within Targets and encouraging initial EVX-01
Phase 2 data showcase significant progress in our Pipeline. Within Responders, we have obtained proof-of-principle for our
checkpoint inhibitor responder model.
The refined strategy also means reduced focus
on Evaxion-driven clinical trials, significantly reducing the cash burn. Combined with a stronger focus on value realization based upon
our AI-Immunology platform, we have the ambition of being able to generate full-year 2024 business development income equal to
our cash burn in 2024, excluding financing activities. We believe we are set for strong business execution based on our refined strategy."
The Evaxion Three-Pronged Strategy
Christian Kanstrup continued, "I am also
very pleased with the bridge financing round we just priced. It is an important element in our long-term financing strategy. The investor
base in the round consists of existing investors, management, and the board of directors, as well as new investors. The largest new investor
is MSD Global Health Innovation Fund (MSD GHI), the corporate venture capital arm of Merck & Co., Inc., Rahway, NJ, USA,
accounting for some 25% of the private placement. I am looking very much forward to be working with the capable team from MSD GHI. We
believe this financing round shows strong confidence in our future business outlook."
"We are also excited to see that the validation
of the AI-Immunology platform has continued. The EDEN AI prediction model has been validated for B-cell antigen discovery
across seven different pathogens and formed a central component of the two important partnerships Evaxion entered into during the third
quarter. One of these partnerships brings together AI-discovered antigens and mRNA technology - a first in the Evaxion pipeline.
EDEN and the T-cell epitope discovery model, RAVEN , are pivotal components of the other partnership forged with a leading
pharmaceutical company to discover and develop vaccines against a pathogen with high unmet medical need for which no vaccines are available.
Evaxion plans to build on this momentum and leverage our AI-Immunology platform to pursue new partnerships for novel vaccine targets
within infectious diseases."
"This quarter has also seen significant
developments in our cancer portfolio and capabilities. A comprehensive clinical update on the EVX-01 Phase 2 trial shared at the SITC
conference confirms the encouraging Phase 1 immune profile seen for our lead personalized cancer vaccine asset. This achievement solidifies
our confidence in the potential AI-Immunology holds at becoming a new treatment paradigm for metastatic melanoma."
"Another truly exciting element in the AI-Immunology
platform is the ObsERV model, which is unique to Evaxion and allows us to harness a new source of tumor-specific antigens in oncology
patients. With ObsERV , we hope to expand the therapeutic reach of personalized cancer vaccines to patients with high mutational
burden tumors but low numbers of high-quality neoantigens and patients with low tumor mutational burden who would otherwise not qualify
for many of the treatment options available today. One exciting possibility we are currently looking into is whether we could use ObsERV
to identify shared cancer antigens in particular cancer subtypes. This would hold the promise to develop the first precision cancer vaccines
targeting indications with no equivalent treatment option to date. Details on this principle were shared at ASH in December this
"With the recent development within cancer
and infectious diseases, we have been seeing a further confirmation of our approach and are looking forward to discussing partnering opportunities
across all parts of our strategy and associated with our three-pronged business model: Targets, Pipeline, and Responders."
Anticipated 2024 Milestones
AI-Immunology - Launch of EDEN model 5.0, mid-2024
EVX B2 mRNA - Preclinical proof of principle obtained, Q3 2024
Recent Events (July-December 2023)
Christian Kanstrup Leads Evaxion's AI
Evaxion appoints Christian Kanstrup as CEO, emphasizing
his unique leadership and strategic development skills. Kanstrup's vision aims to harness the full potential of Evaxion's
AI platform for therapeutic innovation.
Evaxion's EDEN Model Validated:
Revolutionizing Vaccine Development
Evaxion shared data at the Vaccines Europe conference
validating the EDEN model for bacterial vaccine discovery. This groundbreaking achievement emphasizes the models' ability
to swiftly generate novel vaccine targets, offering a faster, cheaper, and lower-risk approach to vaccine development. CEO Christian Kanstrup
and Founder Andreas Holm Mattsson highlight its potential impact on high unmet medical needs, signaling a paradigm shift in vaccine discovery.
Evaxion Initiates AI-Designed Vaccine Program
EVX-B3 in Collaboration with Leading Pharmaceutical Partner
Evaxion Biotech launches EVX-B3, an AI-guided
vaccine program, in collaboration with a leading pharmaceutical company. Leveraging Evaxion's EDEN and RAVEN AI models,
the project aims to efficiently identify protective antigens against an undisclosed bacterial pathogen, addressing a critical global health
concern. The collaborative effort highlights Evaxion's dedication to harnessing AI for innovative vaccine design.
Evaxion and Afrigen Join Forces for Gonorrhea
Evaxion Biotech partners with Afrigen Biologics
to develop an mRNA vaccine against gonorrhea, utilizing EDEN -discovered targets. The collaboration, leveraging mRNA technology
from the WHO and Medicines Patent Pool, aims to address the global medical need for a gonorrhea vaccine. Evaxion CEO Christian Kanstrup
sees this collaboration as a strategic step to bring AI-designed vaccines to market, emphasizing the importance of identifying the right
Evaxion's EVX-01 Phase 2 Trial Shows
Promise in Personalized Cancer Treatment
Evaxion Biotech reports encouraging Phase 2 data
for its personalized cancer vaccine, EVX-01, confirming earlier Phase 1 findings. Notably, a metastatic melanoma patient with initial
progressive disease showed significant and continuous tumor reduction after EVX-01 treatment. CEO Christian Kanstrup highlights the potential
of their AI-Immunology platform to revolutionize oncology.
Webinar: Evaxion Shares Insights on EVX-01
Phase 2 Clinical Data
Evaxion Biotech hosted an online webinar on November 8
featuring KOL Professor Adnan Khattak, one of the principal investigators of the EVX-01 Phase 2 clinical trial. The 30-minute event explores malignant
melanoma, summarizes Phase 1 results, and details the Phase 2 update.
Evaxion Introduces AI Model for Predicting
Cancer Immunotherapy Responses
Evaxion unveils its AI model at the
Biomarkers & Precision Oncology Europe conference, aiming to predict patient responses to cancer immunotherapy. The model
shows promise in enhancing outcomes and reducing healthcare costs, aligning with Evaxion's commitment to advancing the
AI-Immunology Responders area.
Evaxion Unveils Innovative Precision Vaccine
Concept for Hematological Malignancies
Evaxion announces a groundbreaking precision vaccine
concept for hematological malignancies at the 65th American Society of Hematology (ASH) Annual Meeting. The use of AI-Immunology
to target endogenous retroviruses represents a significant advancement, offering tailored vaccines for hematological malignancies. The
upcoming oral presentation on December 9 signifies a major milestone in Evaxion's pursuit of innovative cancer solutions.
Third Quarter of 2023 Financial Results

Frequently Asked Questions

What is Evaxion's cash position as of September 30, 2023?

Evaxion reported cash and cash equivalents of $2.6 million.

How much does Evaxion plan to raise in its bridge financing round?

The company expects to raise approximately $5.3 million in the financing round.

What is the focus of Evaxion's AI-Immunology platform?

The platform aims to develop vaccines powered by AI to address unmet needs.

What is the anticipated cash burn for Evaxion in 2024?

Evaxion anticipates a cash burn of $14 million for 2024, excluding financing activities.

Which investor is the largest in Evaxion's recent financing round?

MSD Global Health Innovation Fund is the largest new investor, holding 25%.

Last updated: Dec 19, 2023