COPENHAGEN, Denmark, Aug. 10, 2022 (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 its second quarter 2022 financial results and provided an operational and business update.
Lars Wegner, CEO of Evaxion, said: “Evaxion announced multiple exciting milestones in the second quarter of 2022. We expanded our DNA oncology vaccine program into non-small cell lung cancer, identified gonorrhea as our second bacterial product target and successfully produced our personalized melanoma immunotherapies for our dedicated clinical trial of EVX-02 for resectable melanoma. We expect to begin the Phase 2b trial combining EVX-01 with Merck’s KEYTRUDA®, for treatment of patients with metastatic melanoma, in the second half of 2022. We believe that these significant steps, including the progression of our clinical programs and the manufacture of clinical supplies, highlight the potential for our exciting pipeline of cancer therapies to improve the treatment landscape in melanoma and other cancers.”
Dr. Wegner continued, “Evaxion’s goal is to develop our programs through Phase 2 before seeking to out-license them. We are actively discussing potential partnerships with multiple pharmaceutical and biotechnology companies. As of June 30, 2022, our cash reserves totaled $25.3 million. We expect these funds to support our product development efforts for the next 12 months.”
Operational and Business Highlights in the Second Quarter of 2022
Events after the Reporting Period
Expected Milestones in the Second Half of 2022
Expected Milestones in First Half of 2023
Second Quarter 2022 Financial Results
Guidance
Webcast and Conference Call
Evaxion will host a webcast and conference call today, August 10, at 8:30 a.m. EDT.
To dial-in for the conference call, please use the following details:
US: +1-844-825-9789
International: +1-412-317-5180
Conference ID: 10169785
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
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About Evaxion
Evaxion Biotech A/S is a clinical-stage biotech company developing AI-powered immunotherapies. With our proprietary and scalable AI technology, we decode the human immune system to discover and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Evaxion has a broad pipeline of novel product candidates, including three patient-specific cancer immunotherapies. It is located in Hørsholm, Denmark, with 70 employees.
For more information Evaxion Biotech A/S Bo Karmark Chief Financial Officer [email protected] +45 27 10 20 50 | LifeSci Advisors LLC Corey Davis, Ph.D. Managing Director [email protected] 212-915-2577 |
Source: Evaxion Biotech
Forward-looking statement
This announcement contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this announcement regarding the Company’s future operations, plans and objectives are forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this announcement about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “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 or the negative thereof. 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 associated with the Company’s financial condition and need for additional capital; risks associated with the Company’s development work; cost and success of the Company’s product development activities and preclinical and clinical trials; risks related to commercializing any approved pharmaceutical product developed using the Company’s AI platform technology, including the rate and degree of market acceptance of the Company’s product candidates; risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture; risks associated with the Company’s inability to enter into partnerships; risks related to government regulation; risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s ADSs and ordinary shares, risks associated with the pandemic caused by the coronavirus known as COVID-19 and the emergence and prevalence of COVID-19 variants, such as the Delta and Omicron variant and certain related variants such as the Omicron BA.4 and BA.5 variants, risks associated with the invasion of the Ukraine by Russia and other risks and uncertainties affecting the Company’s business operations and financial condition.
Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, see the risks described in the “Risk Factors” section included in the Company’s Annual Report on Form 20-F filed on March 31, 2022 and the Company’s current and future reports filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this announcement speak only as of the date hereof, and except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
Evaxion Biotech A/S
Consolidated Statements of Financial Position Data (Unaudited)
(USD in thousands)
Jun 30, | Dec 31, | ||||||
2022 | 2021 | ||||||
Cash and cash equivalents | $ | 25,252 | $ | 32,166 | |||
Total assets | 34,004 | 40,163 | |||||
Total liabilities | 13,854 | 7,726 | |||||
Share capital | 3,844 | 3,755 | |||||
Other reserves | 76,632 | 79,114 | |||||
Accumulated deficit | (60,326 | ) | (50,432 | ) | |||
Total equity | 20,150 | 32,437 | |||||
Total liabilities and equity | $ | 34,004 | $ | 40,163 |
Evaxion Biotech A/S
Consolidated Statements of Comprehensive Loss Data (Unaudited)
(USD in thousands, except per share data)
Three Months | Six months | ||||||||||||||
Ended Jun 30 | Ended Jun 30 | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Research and development expenses | $ | 4,112 | $ | 5,111 | $ | 8,916 | $ | 9,004 | |||||||
General and administrative expenses | 2,147 | 1,915 | 3,742 | 3,197 | |||||||||||
Operating loss | (6,259 | ) | (7,026 | ) | (12,658 | ) | (12,201 | ) | |||||||
Finance income | 1,539 | 33 | 2,058 | 1,005 | |||||||||||
Finance expenses | (225 | ) | (495 | ) | (383 | ) | (792 | ) | |||||||
Net loss before tax | (4,945 | ) | (7,488 | ) | (10,983 | ) | (11,988 | ) | |||||||
Income tax benefit | 177 | 669 | 424 | 1,076 | |||||||||||
Net loss for the period | $ | (4,768 | ) | $ | (6,819 | ) | $ | (10,559 | ) | $ | (10,912 | ) | |||
Net loss attributable to equity holders of Evaxion Biotech A/S | $ | (4,768 | ) | $ | (6,819 | ) | $ | (10,559 | ) | $ | (10,912 | ) | |||
Loss per share – basic and diluted | $ | (0.20 | ) | $ | (0.36 | ) | $ | (0.45 | ) | $ | (0.59 | ) | |||
Number of shares used for calculation (basic and diluted) | 23,361,533 | 19,198,668 | 23,283,107 | 18,535,685 |