Evaxion A/S F-1/A, filed Jan 28, 2025

Evaxion A/S (EVAX)

F-1/A 2025-01-28

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	ABOUT THIS PROSPECTUS					v
	SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS					vii
	PROSPECTUS SUMMARY					1
	RISK FACTORS					20
	DIVIDEND POLICY					40
	MARKET, INDUSTRY AND OTHER DATA					40
	USE OF PROCEEDS					41
	CAPITALIZATION					42
	DILUTION					44
	BUSINESS OVERVIEW					46
	MANAGEMENT					109
	SHARE OWNERSHIP					114
	DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION					117
	DESCRIPTION OF AMERICAN DEPOSITARY SHARES					135
	MATERIAL INCOME TAX CONSIDERATIONS					143
	DESCRIPTION OF SECURITIES WE ARE OFFERING					154
	PLAN OF DISTRIBUTION					157
	EXPENSES OF THE OFFERING					160
	LEGAL MATTERS					160
	EXPERTS					160
	WHERE YOU CAN FIND MORE INFORMATION					160
	INFORMATION INCORPORATED BY REFERENCE					161
	DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES					162

Figure 1	A clearly differentiated position with AI based drug discovery and development	2
Figure 2	The Evaxion Three-Pronged Business Model	3
Figure 3	2024 company milestones	4
Figure 4	2025 company milestones	5
Figure 5	The AI-Immunology™ platform	6
Figure 6	The Evaxion pipeline	9
Figure 7	Our AI models and vaccine pipeline	47
Figure 8	A clearly differentiated position with AI based drug discovery and development	51
Figure 9	The Evaxion three-pronged business model	52
Figure 10	2024 milestones	53
Figure 11	2025 company milestones	54
Figure 12	Illustration of mechanisms within the tumor cell that are required for a neoantigen to have a clinical effect in patients	57
Figure 13	Benchmark study of PIONEER™ against state-of-the-art, public tools for number of hits identified in the top 10 best-ranked neoantigens	58
Figure 14	PIONEER™ improvement demonstrated in a preclinical study	59
Figure 15	Our process for manufacturing a personalized cancer vaccine	61
Figure 16	Our immuno-oncology product candidates derived from PIONEER™ and ObsERV™	62
Figure 17	Clinical design of the first-in-human Phase 1/2a clinical trial in the EVX-01 program	64
Figure 18	Patient disease status, treatment outcome and immune response from the EVX-01 phase 1/2a clinical trial	65
Figure 19	% change in target lesion size for patients treated with EVX-01	65
Figure 20	Dose-responsiveness of immunogenic neoantigens. Pre, immune responses to EVX-01 neopeptides before vaccination, Post; Immune responses to EVX-01 neopeptides after vaccination	66
Figure 21	Frequency of immunogenic neoantigens in patients	67
Figure 22	Correlation between PIONEER quality score and immunogenicity	68
Figure 23	Kaplan-Meier plots displaying PFS of patients based on TMB high/low calculated FDA guidelines (left) Median PIONEER score (right)	68
Figure 24	Schematic presentation of the EVX-01 Phase 2 clinical trial design. Each patient receives 18 cycles with pembrolizumab (approximately two years)	69
Figure 25	Vaccine neoantigen-specific T-cell responses induced during the priming	69
Figure 26	Vaccine-specific CD4+ and CD8+ T-cells were analyzed by intracellular cytokine staining (ICS) and flow cytometry after in vitro expansion	70
Figure 27	Immunogenicity of individual EVX-01 neoantigen (neoAg) and correlation with neoAg quality score	70
Figure 28	Clinical event timeline and change in tumor target lesion size	71
Figure 29	Immunogenicity and correlation analysis between AI-Immunology™ and immune response	72
Figure 30	Illustration of our two neoantigen targeting DNA therapies, EVX-02 and EVX-03	73
Figure 31	Anti-tumor effect of the mouse EVX-02 surrogate vaccine	74
Figure 32	In vivo tumor study investigating the combinatorial effect of mEVX-02 and anti-mPD-1 antibody.	75
Figure 33	In vivo pre-clinical data for EVX-03	76

Figure 34	mEVX-02 A) and mEVX-03 B) dose-dependently inhibited the growth of subcutaneous CT26 tumors. Antitumor of EVX-02 and EVX-03 was obtained at doses as low as 5 and 0.25 μg, respectively	77
Figure 35	Pre-clinical data for mEVX-03 containing ObsERV™ identified ERV antigens (mEVX-03_ERV_CT26)	77
Figure 36	Results obtained in GLP toxicology study of EVX-03	78
Figure 37	Prediction of patient response to immunotherapy from immunogenomic profiles in baseline tumor biopsy	79
Figure 38	Prediction of patient response to immunotherapy from genomic profiles, neoantigen and ERV antigen signatures in baseline tumor biopsy	80
Figure 39	EDEN™ is a self-taught AI model that provides important insight into what makes antigens elicit a protective immune response. EDEN™ identifies novel protective proteins by recognizing abstract features shared with known highly protective proteins	82
Figure 40	Our approach to bacterial vaccine discovery and design	83
Figure 41	Correlation between EDEN prediction and protection	85
Figure 42	EDEN™ outperform reverse vaccinology	86
Figure 43	Multicomponent approach to the development of EVX-B1	87
Figure 44	Assessing protection of EVX-B1 in a mouse sepsis model	89
Figure 45	Assessing protection of EVX-B1 in a mouse skin infection model	89
Figure 46	IgG titers. Mice were immunized with EVX-B1	90
Figure 47	EVX-B1 prevents both disease and infection as the bacterial burden in the kidneys is blocked for at least 30 days post infection	90
Figure 48	EVX-B2 is composed of a fusion protein of NGO0265 and NGO1549 formulated with adjuvant GLA-SE	92
Figure 49	EVX-B2 induce significant protection against challenge in a N. gonorrhoeae vaginal colonization model	93
Figure 50	Both antigens used in the product candidate induce protection, which was enhanced when the antigens were fused together, as was the case in EVX-B2	94
Figure 51	EVX-B2 demonstrates high level of immunogenicity as specific antibodies can be detected already after one immunization	94
Figure 52	Cellular immune response induced by EVX-B2	95
Figure 53	EVX-B2 immune sera demonstrate broad bacterial killing activity	95
Figure 54	RAVEN™ workflow with EDEN™ integration	97
Figure 55	Vaccination with RAVEN™ identified SARS-CoV-2 T-cell epitopes protects against lethal disease	99
Figure 56	Engraftment of CD4+ T-cell epitope in the influenza hemagglutinin antigen	99

	For The Year Ended December 31,
	2023		2022		2021
	(USD in thousands, except per share amounts)
Revenue		73		—		—
Research and development		(11,916)		(17,056)		(19,583)
General and administrative		(10,354)		(8,208)		(6,251)
Operating loss		(22,197)		(25,264)		(25,834)
Finance income		963		2,831		2,039
Finance expense		(1,681)		(1,508)		(915)
Net loss before tax		(22,915)		(23,941)		(24,710)
Income tax benefit		790		772		178
Net loss for the year		(22,125)		(23,169)		(24,532)
Net loss attributable to shareholders of Evaxion Biotech A/S.		(22,125)		(23,169)		(24,532)
Loss per share – basic and diluted		(0,81)		(0,98)		(1,26)

	Six Months Ended June 30,
	2024		2023		2022
	(USD in thousands, except per share amounts)
Revenue		205		—		—
Research and development		(5,588)		(6,788)		(8,916)
General and administrative		(3,594)		(5,283)		(3,742)
Operating loss		(8,977)		(12,071)		(12,658)
Finance income		5,838		332		2,058
Finance expense		(2,282)		(604)		(383)
Net loss before tax		(5,421)		(12,343)		(10,983)
Income tax benefit		417		419		424
Net loss for the year		(5,004)		(11,924)		(10,559)
Net loss attributable to shareholders of Evaxion Biotech A/S.		(5,004)		(11,924)		(10,559)
Loss per share – basic and diluted		(0.10)		(0.46)		(0.45)

	Nine Months Ended September 30,
	2024		2023		2022
	(USD in thousands, except per share amounts)
Revenue		3.222		—		—
Research and development		(8,202)		(9,618)		(12,983)
General and administrative		(5,728)		(8,215)		(5,756)
Operating loss		(10,708)		(17,833)		(18,739)
Finance income		5,922		404		2,761
Finance expense		(2,665)		(786)		(918)
Net loss before tax		(7,451)		(18,215)		(16,896)
Income tax benefit		513		613		599
Net loss for the year		(6,938)		(17,602)		(16,297)
Net loss attributable to shareholders of Evaxion Biotech A/S.		(6,938)		(17,602)		(16,297)
Loss per share – basic and diluted		(0.13)		(0.66)		(0.69)

	Sep 30, 2024		Jun 30 2024		Dec 31, 2023		Dec 31, 2022
Cash and cash equivalents		4,576		7,993		5,583		13,184
Total assets		15,185		15,231		12,889		22,025
Total liabilities		15,111		13,978		17,618		13,772
Share capital		8,732		8,244		5,899		3,886
Other reserves		106,245		105,983		99,946		90,262
Accumulated deficit		(114,903)		(112,974)		(107,860)		(85,845)
Total equity before derivative warrant liability		74		1,253		(2,015)		8,303
Effect from derivative liabilities from investor warrants		—		—		(2,714)		—
Total equity		74		1,253		(4,729)		8,303
Total liabilities and equity		15,185		15,231		12,889		22,025

$m	100%	% of Total
Gross Proceeds from Offering			100%
Use of Proceeds
Placement Agents Fees and Expenses			7%
Offering Expenses			6%
Research & Development			50%
General & Administrative			37%
Total Use of Proceeds			100%

	Sep 30, 2024		As adjusted		Pro forma as adjusted
	USD in thousands
Cash and cash equivalents		4,576		12,552		21,942
Total assets		15,185		23,161		32,551
Total liabilities		15,111		15,111		15,111
Share capital		2,183		4,149		7,306
Other reserves		112,794		118,804		125,038
Accumulated deficit		(114,903)		(114,903)		(114,903)
Total equity		74		8,050		17,440

Public offering price per ADS	$	6.03
Historical net tangible book value per ADS as at September 30, 2024	$	3.55
Increase in net tangible book value per ADS attributable to transactions in the period through the present offering, as described above	$	0.74
Pro forma net tangible book value per ADS as of September 30, 2024	$	4.29
Dilution per ADS to new investors purchasing ADSs in this offering	$	1.74

	Grade 1			8 (88.8)%
	Grade 2			4 (44.4)%
	Grade 3			0 (0)%
	Leading to drug discontinuation			0 (0)%
	Leading to death			0 (0)%

Assessments
Improvement from SD to PR/CR			2/5 (40.0%)
Improvement from PR to CR			2/9 (22.2%)
Overall improvement in response			4/16 (25%)
ORR			*11/16 (68.8%)
Median follow up (months)			14.8 (4.7 – 21.3)
Median OS			NR
Median PFS			NR

Bacterial species	In vivo PoC	In vivo model (mouse challenge models)	IP filed
Staphylococcus aureus	✓	Lethal peritonitis and skin abscess model	✓
Pseudomonas aeruginosa	✓	Lethal peritonitis and lethal acute pneumonia model	✓
Non-typeable Haemophilus influenzae	✓	Lung colonization model	✓
Moraxella catarrhalis	✓	Lethal peritonitis and lung colonization model	✓
Neisseria gonorrhoeae	✓	Vaginal colonization model	✓
Acinetobacter baumannii	✓	Lethal acute pneumonia model	✓
Klebsiella pneumoniae	✓	Lethal peritonitis and lethal acute pneumonia model	✓

# ID	Proteins	No. of Experiments		No. of Test Mice		No. of Control Mice		% Survival of Test Mice		% Survival of Control Mice		Difference in Survival (Test vs. Control)
1	EDEN-1		4		59		60		76%		28%		48%
2	EDEN-2		2		24		24		58%		13%		46%
3	EDEN-3		3		43		44		77%		32%		45%
4	EDEN-4		2		28		28		68%		25%		43%
5	EDEN-5		2		28		28		68%		25%		43%
6	EDEN-6		2		27		28		85%		43%		42%
7	EDEN-7		3		36		36		61%		19%		42%
8	EDEN-8		5		61		64		51%		9%		41%
9	EDEN-9		3		43		44		63%		30%		33%
10	EDEN-10		3		36		36		69%		36%		33%
11	EDEN-11		3		32		35		53%		20%		33%
12	EDEN-12		3		42		42		62%		31%		31%
13	EDEN-13		3		36		36		47%		28%		19%

Function	Number
Clinical Research & Development		4
Scientific Research & Development		20
Supporting Functions		17
Commercial & Business Development		3
TOTAL		44

Name	Age	Position(s)
Executive Management:
Christian Kanstrup, MSc(1)	52	Chief Executive Officer
Thomas Frederik Schmidt, MSc(2)	53	Chief Financial Officer (interim)
Birgitte Rønø, Ph.D.	47	Chief Scientific Officer
Andreas Holm Mattsson	49	Chief AI Officer

	Years Ended December 31,
	2024		2023		2022
	(USD in thousands)
Bo Karmark (CFO)(8)
Salary		46		269		160
Bonus		—		65		74
Other employee benefits		(23)		31		35
Total		23		365		269
Jesper Nygaard Nissen (COO and CFO)(9)
Salary		233		269		209
Bonus(10)		50		—		44
Other employee benefits(10)		(2)		27		39
Total		281		296		292
Lars Staal Wegner(5)
Salary		—		—		352
Bonus		—		—		71
Other employee benefits		—		—		(16)
Total		—		—		407
Niels Iversen Møller (CBO)(2)
Salary		—		—		67
Bonus		—		—		6
Other employee benefits		—		—		2
Total		—		—		75
Andreas Holm Mattsson (CAICO)
Salary		255		233		229
Bonus(10)		12		—		68
Other employee benefits(10)		20		13		22
Total		287		246		319
Erik Deichmann Heegaard, Ph.D., DMSc (CMO)(3)
Salary		70		269		265
Bonus		29		—		52
Other employee benefits		(37)		70		162
Total		62		339		479
Birgitte Rønø, Ph.D. (CSO)(4)
Salary		261		233		235
Bonus(10)		23		—		45
Other employee benefits(10)		30		36		56
Total		314		269		336
Christian Kanstrup (CEO)(7)
Salary		360		116		—

	Years Ended December 31,
	2024		2023		2022
	(USD in thousands)
Marianne Søgaard (Chairman of the Board of Directors)(1)
Board and committee fees		143		145		132
Other Fee		33		17		23
Share-based compensation(5)		32		31		10
Total		208		193		165
Roberto Prego
Board and committee fees		61		63		57
Other Fee		—		—		—
Share-based compensation(5)		8		5		5
Total		69		68		62
Steven Projan(4)
Board and committee fees		—		24		63
Other Fee		—		—		—
Share-based compensation		—		(2)		5
Total		—		22		68
Lars Holtug(2)
Board and committee fees		59		59		59
Other Fee		—		—		—
Share-based compensation(5)		8		5		5
Total		67		64		64

Board	Warrants granted		Exercise price USD		Expiration date
Marianne Søegaard		40,000		0.4		31/12/2031
Roberto Prego Pineda		20,000		0.4		31/12/2031
Lars Holtug		20,000		0.4		31/12/2031
Niels Iversen Møller		20,000		0.4		31/12/2031

	Before Offering				After Offering
Name of Beneficial Owner	Number		Percent		Number		Percent
5% or Greater Shareholders
Merck Global Innovation Fund LLC(1)		7,720,588		6.7		7,720,588		3.75
Executive Management
Christian Kanstrup(2)		1,554,507		1.4		1,554,507		0.8
Andreas Holm Mattsson(3)		4,289,341		3.8		4,289,341		2.1
Birgitte Rønø(4)		187,170		—		187,170		—
Directors
Roberto Prego(5)		561,156		0.5		561,156		0.3
Lars Holtug(6)		179,978		—		179,978		—
Marianne Søgaard(7)		1,777,471		1.6		1,777,471		0.9
Lars Staal Wegner(8)		681,842		0.6		681,842		0.3
All current directors and executive management, as a group (7 persons)		9,231,465		7.9		9,231,465		4.5

Date	Transaction	Share Capital After Transaction		Price Per Share (DKK) (Rounded)
August 2008	Formation (Nominal DKK 1)		250,000		1.00
March 2014	Cash contribution (Nominal DKK 1)		268,148		120.00
December 2014	Cash contribution (Nominal DKK 1)		316,751		178.22
December 2015	Cash contribution (Nominal DKK 1)		336,549		435.76
March 2016	Cash contribution (Nominal DKK 1)		342,880		432.12
September 2017	Cash contribution (Nominal DKK 1)		358,806		1,034.75
March 2019	Transfer of reserves (Nominal DKK 1)		717,612		1.00
July 2019	Cash contribution and debt conversion (Nominal DKK 2)		836,994		914.71(avg)
December 2019	Cash contribution (Nominal DKK 1)		843,564		1,037.50
September 2020	Cash contribution (Nominal DKK 1)		884,974		1,002.90

Persons depositing or withdrawing shares or ADS holders must pay:			For:
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)			Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property
			Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates
$0.05 (or less) per ADS			Any cash distribution to ADS holders

Persons depositing or withdrawing shares or ADS holders must pay:			For:
A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs			Distribution of securities distributed to holders of deposited securities (including rights) that are distributed by the depositary to ADS holders
$0.05 (or less) per ADS per calendar year			Depositary services
Registration or transfer fees			Transfer and registration of shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw shares
Expenses of the depositary			Cable and facsimile transmissions (when expressly provided in the deposit agreement) Converting foreign currency to United States dollars
Taxes and other governmental charges the depositary or the custodian has to pay on any ADSs or shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding taxes			As necessary
Any charges incurred by the depositary or its agents for servicing the deposited securities			As necessary

SEC registration fee	$	4,153
FINRA filing fee	$	4,569
Printing and engraving expenses	$	90,000
Legal fees and expenses	$	540,000
Accounting fees and expenses	$	45,000
Miscellaneous expenses	$	40,000
Total	$	723,722

Exhibit Number	Exhibit Description	Form	Date	Incorporated by Reference Number	File Number
1.1**	Form of Placement Agency Agreement for this Offering
3.1	Articles of Association currently in effect (including English translation)	6-K	1/27/2025	1.1	001-39950
4.1	Form of Deposit Agreement among the Registrant, the depositary and holders and beneficial owners of the American Depositary Shares	F-6	01/12/2021	1	333-252038
4.2	Form of Specimen American Depositary Receipt (included in Exhibit 4.1)
4.3	Form of Securities Purchase Agreement	6-K	12/21/2023	10.1	001-39950
4.4	Form of Investment Agreement	6-K	12/21/2023	10.2	001-39950
4.5	Form of Registration Rights Agreement	6-K	12/21/2023	10.3	001-39950
4.6	Form of Warrant Certificate	6-K	12/21/2023	4.1	001-39950
4.7	Form of Pre-Funded Warrant for this Offering	F-1	12/17/2024	4.7	333-283304
4.8	Form of Ordinary Warrant	F-1	12/17/2024	4.8	333-283304
5.1	Form of Opinion of Mazanti-Andersen regarding the validity of the Ordinary Shares being registered	F-1	12/17/2024	5.1	333-283304
8.1	Form of Tax Opinion of Mazanti-Andersen	F-1	12/05/2024	8.1	333-283304
10.1	CAF®09b Supply, Patent Know How & Trademark License Agreement dated November 30, 2020, between Statens Serum Institut and Evaxion Biotech A/S	F-1	01/08/2021	10.1	333-251982

Signature		Title	Date
/s/ Christian Kanstrup Christian Kanstrup		Chief Executive Officer (Principal Executive Officer)	January 28, 2025
/s/ * Thomas Frederik Schmidt		Interim Financial Officer	January 28, 2025
/s/ * Marianne Søgaard		Director	January 28, 2025
/s/ * Roberto Prego		Director	January 28, 2025
/s/ * Lars Wegner		Director	January 28, 2025
*By:	/s/ Christian Kanstrup Christian Kanstrup Attorney-In-Fact

	Very truly yours,

	LAKE STREET CAPITAL MARKETS, LLC

	By:
		Name: Michael Townley
		Title: Head of Investment Banking

	Address for notice:
	920 Second Avenue South, Suite 700
	Minneapolis, Minnesota 55402
	Attention: Michael Townley, Head of Investment Banking Email: mike.townley@lakestreetcm.com

	JONESTRADING INSTITUTIONAL SERVICES LLC

	By:
		Name: Burke Cook
		Title: General Counsel

	Address for notice:
	900 Island Park Drive, Suite 200
	Daniel Island, South Carolina 29492
	Attention: Burke Cook, General Counsel Email: legal@jonestrading.com

EVAXION BIOTECH A/S

By:
	Name: Christian Kanstrup
	Title: Chief Executive Officer


ADSs:                  _________________

Prefunded Warrant ADSs:  ____________	Beneficial Ownership Blocker ¨ 4.99% or ¨ 9.99%

Ordinary Warrant ADSs:   ____________	Beneficial Ownership Blocker ¨ 4.99% or ¨ 9.99%

EIN Number: _______________________