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Fourth quarter and full year 2022 financial results and business update

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  • Evaxion presented promising data from its Phase 1/2a clinical trial of EVX-02 in patients with late-stage melanoma at the 2023 AACR meeting
  • EVX-03, a DNA-based personalized cancer vaccine, is expected to have a CTA filing in Q3 2023 and start a Phase 1 trial in solid tumor patients in Q4 2023
  • Recent collaborations with Pantherna Therapeutics GmbH (utilizing PIONEER™) and ExpreS2ion Biotechnologies ApS (utilizing RAVEN™) highlight the broad utility of Evaxion’s differentiated AI platforms, which now includes the new ObsERVTM AI technology, which is designed to identify patient-specific viral targets from endogenous retroviruses (ERVs) known to be overexpressed in certain tumors
  • $13 million in cash and equivalents as of December 31, 2022 is expected to fund operations into December 2023
  • Evaxion to host a webcast and conference call today, April 27 at 8:30 am EDT

COPENHAGEN, Denmark, April 27, 2023 (GLOBE NEWSWIRE) — Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, announced today the fourth quarter and full-year 2022 financial results and provided a business update.

“Evaxion made excellent progress across its core AI technologies for vaccine target discovery in 2022 and early 2023, validated through the progress in the pipeline,” said Per Norlén, Chief Executive Officer of Evaxion. “Looking back on our accomplishments, I’d like to highlight the initial proof-of-concept clinical trials in melanoma for EVX-01 and EVX-02, developed using our PIONEER™ artificial intelligence (AI)-platform, and our next-generation immuno-oncology candidate, EVX-03, scheduled to begin clinical testing in Q4 2023. We also announced another proprietary AI technology, ObsERV™, targeting endogenous retroviruses (ERVs), which is planned to be incorporated into our personalized cancer vaccines. Over the last six months, as we have refined our development strategy and business focus, re-aligned our organization and extended our cash runway, I am grateful to the outstanding work of the team and remain impressed by the strength of Evaxion’s core AI-science.”

Per concluded, “We recently reported promising clinical results from the Phase 1/2a EVX-02 study in melanoma at the 2023 annual meeting for the American Association for Clinical Research (AACR). Looking ahead to the rest of the year, we plan to report final Phase 1/2a results and interim Phase 2 data from the EVX-01 program in melanoma. In addition, we intend to initiate recruitment in a Phase 1 study with EVX-03 in Q4 2023. We look forward to inform the investment community and our key stakeholders with further updates on our progress throughout the year.”

Pipeline Updates

Technology advances:
Novel ObsERV™ technology — In March 2023, Evaxion reported the discovery of a novel new source of antigens for personalized cancer immunotherapy, based on endogenous retroviruses (ERVs). The AI-enabled technology has the potential to make “cold” tumors responsive to immunotherapy, which has the potential to broaden the patient population for immunotherapy significantly.

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Novel mRNA vaccine delivery collaboration with Pantherna — In February 2023, Evaxion and Pantherna announced promising mRNA vaccine data. The preclinical data demonstrated that tumor neoantigens identified by Evaxion’s AI PIONEER™ platform could drive a strong immune response and lead to complete inhibition of tumor growth when delivered using Pantherna’s proprietary mRNA platform.

Program Overview
EVX-01 (1st generation, Peptide based vaccine, Phase 2 in melanoma) – The ongoing single-arm, multi-center trial (NCT05309421) is evaluating EVX-01 for the treatment of adults with metastatic melanoma in combination with the [PD-1 inhibitor/checkpoint inhibitor/CPI], KEYTRUDA®.

  • The Company plans to present a full read-out of the previous Phase 1/2a study in 12 patients at the American Society for Clinical Oncology (ASCO) Annual Meeting in June 2023, in which interim data demonstrated clinical response in six out of the first nine patients.
  • The Phase 2 study, initiated in September 2022, is expected to enroll up to 20 patients and report interim data in Q4 2023.

EVX-02 (2nd generation, DNA-based vaccine, Phase 1/2a in melanoma) – The single-arm, open-label study (NCT04455503) evaluated EVX-02 in combination with the CPI, nivolumab, in patients with advanced melanoma who had undergone complete surgical resection and were at high risk for recurrence.

  • Data presented at the 2023 AACR meeting showed that all 10 patients who completed the full course of dosing with the EVX-02/CPI combination were relapse-free during the 12-month study period. The treatment also produced neoantigen-specific long-lasting T-cell immune responses involving both CD4+ and CD8+ T-cells. The EVX-02/CPI treatment combination was well tolerated, and only mild EVX-02-associated adverse events (AEs) were observed.

EVX-03 (3rd generation, DNA-based vaccine, Phase 1 study expected to begin in Q4 2023) – EVX-03 is a DNA-based personalized cancer immunotherapy that combines patient-specific neoantigens with personalized ERVs. Bringing these personalized antigens together into a single plasmid construct, armed with a genetic immune adjuvant, will enable Evaxion to develop an immunotherapy with the potential for inducing a robust and patient-specific immune response and for increased efficacy.

  • A clinical trial authorization (CTA) filing with the European Medicines Agency to evaluate the combination of EVX-03 and a CPI is anticipated to be filed in Q3 2023 and the Phase 1 study is anticipated to begin in Q4 2023 in patients with solid tumors.

Infectious diseases programs: based on Evaxion’s EDEN™ and RAVEN™ technologies

Technology advances:
EVX-B1 (S. aureus, preclinical) – Evaxion has demonstrated significant protection from S. aureus infection in both sepsis and skin infection models. The next step for this partnering-ready program is IND-enabling toxicology studies.

EVX-B2 (N. gonorrhoeae, preclinical) – In June 2022, Evaxion announced gonorrhea as a new bacterial vaccine candidate for N. gonorrhoeae. In September 2022, Evaxion announced that the Company, in collaboration with the UMass Chan Medical School, had received a grant from the U.S. National Institutes of Health (NIH) for the development of a lead vaccine candidate.

EVX-V1 (Cytomegavirus/CMV, preclinical) – In December 2022, Evaxion and ExpreS²ion initiated the discovery phase of a joint research collaboration to develop a next generation CMV vaccine candidate that elicits both cellular and humoral antibody responses; this phase will be jointly funded until 2025. After that, the parties could expand the research collaboration into a Development and Commercialization agreement.

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Expected milestones in 2023

  • Q2 2023 – Full readout EVX-01 Phase 1/2a – to be presented at ASCO in June 2023
  • Q4 2023 – Report interim results from EVX-01 Phase 2 trial
  • Q4 2023 – Initiate patient recruitment in a Phase 1 study for EVX-03

Full Year 2022 Financial Results

  • Cash position: As of December 31, 2022, cash and cash equivalents were $13.2 million as compared to $32.2 million as of December 31, 2021. This along with capital raised in Q1 2023 of $4.2 million, is anticipated to be sufficient to fund operations into December 2023.
  • Research and Development expenses were $17.1 million for the year ended December 31, 2022 as compared to $19.6 million for the year ended December 31, 2021. The decrease was primarily related to a decrease in spending on clinical trials, net of grant income and preclinical product candidates countered by an increase in employee-related costs.
  • General and Administrative expenses were $8.2 million for the year ended December 31, 2022 compared to $6.3 million for the year ended December 31, 2021. The increase was primarily related to professional fees incurred by the corporate functions as a listed company.
  • Net loss was $23.2 million for the year ended December 31, 2022 or ($0.98) loss per basic and diluted share as compared to $24.5 million, or ($1.26) loss per basic and diluted share for the year ended December 31, 2021.

Based on the Company’s current cash position, with a cash runway until beginning of December and the need for further funding, our auditors EY have provided an emphasis of matter in their auditors report that there exists substantial doubt about the Company’s ability to continue as a going concern.

Webcast and Conference Call

Evaxion will host a webcast and conference call today, April 27, at 8:30 am EDT.

To dial in for the conference call, please use the following details:

  • US: 877‑407‑0792
  • International: +1‑201‑689‑8263
  • Conference ID: 13727933

Alternatively to access the audio webcast, please visit the events page of Evaxion’s website at: https://evaxion-biotech.com/news-and-events/events/default.aspx

About Evaxion

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Evaxion Biotech A/S is a clinical-stage biotech company developing AI-powered immunotherapies. Evaxion’s proprietary and scalable AI technologies decode the human immune system to discover and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Evaxion has a broad pipeline of product candidates, including three personalized cancer immunotherapies. It is located in Hørsholm, Denmark and is listed on the Nasdaq New York stock exchange. For more information, please visit: www.evaxion-biotech.com.

Source: Evaxion Biotech

Forward-Looking Statements

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from the worldwide COVID-19 pandemic and the ongoing conflict in the region surrounding Ukraine and Russia; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

Evaxion Biotech A/S

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Consolidated Statements of Financial Position Data (Unaudited)

(USD in thousands)

             
       Dec 31,      Dec 31,
    2022   2021
Cash and cash equivalents   $ 13,184   $ 32,166
Total assets     22,025     40,163
Total liabilities     13,722     7,726
Share capital     3,886     3,755
Other reserves     77,076     79,114
Accumulated deficit     (72,659)     (50,432)
Total equity     8,303     32,437
Total liabilities and equity   $ 22,025   $ 40,163
             

Evaxion Biotech A/S

Consolidated Statements of Comprehensive Loss Data (Unaudited)

(USD in thousands, except per share data)

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    Three Months   Twelve months
    Ended Dec 31   Ended Dec 31
       2022      2021      2022      2021
Research and development expenses   $ (4,073)   $ (6,154)   $ (17,056)   $ (19,583)
General and administrative expenses     (2,452)     (1,567)     (8,208)     (6,251)
Operating loss     (6,525)     (7,721)     (25,264)     (25,834)
Finance income     70     746     2,831     2,039
Finance expenses     (590)     (72)     (1,508)     (915)
Net loss before tax     (7,045)     (7,047)     (23,941)     (24,710)
Income tax benefit     173     (1,323)     772     178
Net loss for the period   $ (6,872)   $ (8,370)   $ (23,169)   $ (24,532)
Net loss attributable to equity holders of Evaxion Biotech A/S   $ (6,872)   $ (8,370)   $ (23,169)   $ (24,532)
Loss per share – basic and diluted   $ (0.29)   $ (0.39)   $ (0.98)   $ (1.26)
Number of shares used for calculation (basic and diluted)     24,082,247     21,671,312     23,638,685     19,493,143
                         

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Artificial Intelligence

ZA Tech Rebrands as Peak3, Raises US$35M Series A led by EQT

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SINGAPORE, June 19, 2024 /PRNewswire/ — ZA Tech, the next-generation insurance core system SaaS provider, has rebranded as Peak3. With the successful completion of its US$35 million Series A fundraising from EQT (lead investor) and Alpha JWC Ventures, Peak3 now accelerates its expansion in the EMEA region and investments in complementary data and AI solutions.

In a market dominated by fragmented legacy technology, Peak3 has pioneered a cloud-native, modular insurance core and distribution system that combines comprehensive capabilities for life, health, and property and casualty (P&C) insurance. Since its founding in 2018, Peak3 has become a trusted technology partner to global insurers such as AIA, Generali, Prudential, and Zurich for their digital and traditional business. It has also partnered with leading digital platforms such as Carro, Grab, Klook, and PayPay to build and scale their embedded insurance businesses.
Besides the successful fundraising, Peak3 has recently achieved key milestones underpinning the rebranding. These transformative achievements include launching its first multi-country, multi-tenant core modernisation in Europe, rolling out an integrated customer data and big data platform for scaling analytics and AI capabilities, and establishing its first technology centre in Europe. The rebranding coincides with another major milestone: Issuing over a billion insurance policies on Peak3’s systems – including the first policies issued to North American customers and the first ones to be issued in Africa.
“We have evolved from an embedded insurance pioneer in Asia to a global end-to-end technology partner for the insurance industry,” said Bill Song, Peak3 Group CEO and Co-Founder. “Our new name represents three pinnacles: scaling the heights of innovation, surpassing performance limits, and delivering superior reliability – as we help insurers reach the highest summits of their cloud, data, and AI transformation.”
Bill Song also emphasised the growth opportunity: “There is an incredible tech investment backlog in the US$7-trillion global insurance industry. Continued digitalisation and the proliferation of AI will require structural investments by insurers over the next decade to modernise their core systems. We are uniquely positioned to capture this opportunity by providing the tech core foundations and innovation use cases.” 
To accelerate its growth journey, Peak3 completed its Series A fundraising and welcomed two new investors on its cap table: EQT, a major global technology investor with a deep heritage in Europe, and Alpha JWC Ventures, a leading venture firm in Southeast Asia. With the funding, Peak3 will advance its analytics and AI capabilities toward an intelligent core insurance solution, grow its EMEA operations and establish new system integrator partnerships. Peak3 targets double-digit ARR growth this year and is on the path to reach cashflow breakeven over the coming quarters.
“Peak3 has also proven its capability to deliver greenfield digital insurance initiatives and complex multi-country core modernisation projects in APAC and EMEA. As the lead investor, EQT is committed to empowering Peak3 in its go-to-market acceleration by leveraging our global network,” stated Clara Ho, Partner at EQT.
J.P. Morgan acted as exclusive financial advisor to Peak3 for this Series A fundraising.
For media inquiries and interview requests, please contact Carling Sia, Global Head of Branding and Marketing, at [email protected].
For more information on Peak3, please visit www.peak3.com. For more information on EQT, please visit www.eqtgroup.com.For more information on Alpha JWC Ventures, please visit www.alphajwc.com.
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Lucinity Recognized as One of the Top 100 AI Fintech Companies Globally

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REYKJAVIK, Iceland, June 18, 2024 /PRNewswire/ — Lucinity has been featured in the AIFinTech100 list for 2024, marking its recognition as one of the top AI companies in the financial services industry. The AIFinTech100 list, curated by industry experts, highlights the most innovative fintech companies globally. Lucinity was selected from over 2,000 fintech firms for its problem-solving, market potential, innovation, and customer engagement. Earlier this year, Lucinity was also highlighted as a RegTech100 company.

 
 
This recognition comes amid rapid AI adoption in fintech. According to Fintech Global, research predicts the AI market in fintech will grow from $42.83 billion to $44.08 billion by 2024, reaching $50.87 billion by 2029. Banks alone are expected to spend $4.9 billion on AI platforms by 2024, with a 21.8% annual growth rate since 2019.
Lucinity’s inclusion in the AIFinTech100 list reflects its success in developing AI solutions that enhance efficiencies and cost savings for financial crime operations teams. Notably, Luci, the world’s first Generative AI copilot for financial crime investigations, launched in 2023, leverages Microsoft OpenAI technologies to augment human analysts’ capabilities, reducing investigation times from 3 hours to just 30 minutes. 
Lucinity also recently launched Luci as a copilot plugin at Money20/20. Financial institutions are now able to integrate Luci with any web-based enterprise application including CRM systems, Case Manager systems, and Excel, delivering immediate ROI with zero upfront integration. 
Security remains a significant challenge in AI adoption. Lucinity addresses this by partnering with Microsoft Azure develop a secure infrastructure. With a strong emphasis on compliance, Luci offers comprehensive auditability through its detailed Audit Log functionality.
Guðmundur Kristjánsson (GK), CEO of Lucinity, comments, “Being named in the AIFinTech100 showcases our impact amongst banks and fintech through advanced AI. It underscores our platform’s ability to empower compliance teams, deliver ROI, and reduce operational costs.”
Richard Sachar, Director of FinTech Global, added, “AI is revolutionizing financial services, increasing efficiencies and offering personalized products. This year’s AIFinTech100 list includes top innovators transforming the industry with AI applications.”
Lucinity’s inclusion in the AIFinTech100 list for 2024 follows several achievements, including winning the Microsoft Partner of the Year Awards for Sustainability and Social Impact and Partner of the Year – Iceland. Lucinity was also included in Chartis Research’s FinCrime and Compliance 50 Ranking for 2024 and was recognized as the best tool for Workflow Automation.
Name: Celina PabloEmail: [email protected] +354 792 4321
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CRISIL wins Model Validation Tools and Accelerators category award, other recognitions from Chartis

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Recognized among top 50 financial services firms for analytics and risk tech
MUMBAI, India, June 18, 2024 /PRNewswire/ — CRISIL, a global provider of advanced analytics and risk management solutions, has won the Solution Category award for Model Validation Tools and Accelerators as part of the latest Chartis STORM 2024 report.

Published by Chartis Research, the leading provider of research and analysis on the global market for risk technology, STORM 2024 is an annual report on quantitative technologies and the computational infrastructure supporting it.
Following an extensive evaluation process, which included a risk technology survey, product demo, customer reference checks, and third-party sources of information, CRISIL won the following recognitions:
Solution category award for Model Validation Tools and AcceleratorsRanked Top 25 (#24) in QuantTech50 2024 rankingsRanked Top 25 (#24) in BuySideRisk50 2024 rankingsRanked Top 50 (#38) in RetailFinanceAnalytics50 2024 rankingsThe recognitions reflect the unparalleled value CRISIL brings to its clients through deep domain expertise, specialized analytical and technical knowledge and our global perspective.
Says Jan Larsen, President and Head, CRISIL Global Research & Risk Solutions, “CRISIL is honored by the recognition across multiple STORM50 award categories this year, including being named first place for Model Validation Tools and Accelerators. This is a great testament to the contributions of our team in giving clients and their regulators confidence in the models they use for making critical decisions.”
The core tenets of CRISIL’s value proposition include expertise across asset classes and risk stripes, analytical excellence and regulatory experience, tailored solutions focused on client delight, continuous improvement and technological innovation. 
Says Ashish Vora, President, CRISIL Market Intelligence and Analytics, “This prestigious recognition underscores the global acceptance of our risk management solutions and highlights our unwavering commitment to excellence in the risk technology space. Our Credit+ technology solutions have been instrumental in offering AI-enabled advanced analytics and driving efficiency, and we are particularly proud of the exceptional client feedback we have received for these solutions. We are constantly exploring new ways to enhance customer value and are investing in cutting-edge technology and domain expertise to maintain our position at the forefront of the industry.”
Notable examples of CRISIL’s platforms that help demonstrate this value proposition include: 
Model Infinity: A leading platform for model inventory management and model risk management. This innovative platform empowers our client to centralize all model activities, eliminates manual processes and operational risk, and provides a full audit trail of approvals for modeling assumptions and updates. Scenario Expansion Manager (SEM): A platform for clients to expand, analyze and track all regulatory and internal scenarios used for stress testing. As a centralized repository of scenarios, SEM allows institutions to eliminate redundant internal work and even provide clients the ability to share internal scenarios with one another. Credit+ ICON: The platform enables credit decision-making through its extensive financial spreading and front-end based credit risk scorecard hosting capabilities. Powered by deep domain expertise, AI-driven analytics and extensive configurability, it serves 40+ global clients across 15 countries.Credit+ Early Warning Signals: The AI-powered solution provides banks with actionable insights to monitor their credit quality, lower loan-loss contingencies and track corrective action plan.About CRISIL Market Intelligence & Analytics
About Global Research & Risk Solutions
About CRISIL Limited
Connect with us: LINKEDIN | TWITTER | YOUTUBE | FACEBOOK 
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Disclaimer
This press release is transmitted to you for the sole purpose of dissemination through your newspaper/ magazine/ agency. The press release may be used by you in full or in part without changing the meaning or context thereof but with due credit to CRISIL. However, CRISIL alone has the sole right of distribution of its press releases for consideration or otherwise through any media including websites, portals, etc.
CRISIL has taken due care and caution in preparing this press release. Information has been obtained by CRISIL from sources which it considers reliable. However, CRISIL does not guarantee the accuracy, adequacy or completeness of information on which this press release is based and is not responsible for any errors or omissions or for the results obtained from the use of this press release. CRISIL, especially states that it has no financial liability whatsoever to the subscribers/ users/ transmitters/ distributors of this press release.
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