Abliva — Interim / Quarterly Report 2021

Nov 19, 2021

Interim Report January – September 2021

We continue to build the foundations to deliver on our goal of becoming the leader in the development of therapeutics for patients suffering from primary mitochondrial diseases.

Ellen Donnelly, CEO

Delivering mitochondrial health

Third quarter summary

Endpoint validated enables KL1333 Phase 2/3 study start Favorable feedback supports progressing NV354 into Phase 1

Important events third quarter (Jul - Sep 2021)

• The study to create a primary mitochondrial disease fatigue endpoint for use in the KL1333 Phase 2/3 study was completed.
• The first chronic toxicology study with KL1333 (six months) was completed.
• Favorable feedback was received from UK pharmaceutical regulators (MHRA) on the NV354 preclinical data package.

Financial information

July-September 2021*

• Net revenues: SEK 85,000 (0,000)
• Other operating income: SEK 0,000 (63,000)
• Loss before tax: SEK 34,854,000 (10,078,000)
• Loss per share: SEK 0.09 (0.03)
• Diluted loss per share: SEK 0.09 (0.03)

January-September 2021*

• Net revenues: SEK 103,000 (105,000)
• Other operating income: SEK 0,000 (45,000)
• Loss before tax: SEK 86,624,000 (46,927,000)
• Loss per share: SEK 0.24 (0.20)
• Diluted loss per share: SEK 0.24 (0.20)

* APM Alternative perfomance measures, see definition on page 20.

The Momentum Continues: NV354 moves into clinical development

Abliva continued the momentum in the third quarter (Q3) with significant focus on the study start up activities for KL1333. The highlight of the quarter, however, was the announcement that NV354 has the preclinical data necessary to move into clinical development. With two programs in the clinic in 2022, Abliva continues to build the foundations to deliver on its goal of becoming the leader in the development of therapeutics for patients suffering from primary mitochondrial diseases.

Validation of Mitochondrial Disease endpoint has been completed

A key focus for Abliva over the past six months has been the establishment of the first validated mitochondrial disease-specific endpoint. Over the period the Abliva team, in collaboration with Sprout Health Solutions, tested questions from validated fatigue scales with mitochondrial disease patients to understand the relevance of the questions to mitochondrial disease fatigue. Through in-depth patient discussions and research we have now completed the study and finalized this mitochondrial disease-specific fatigue scale. The team is looking forward to review of the scale by the FDA and the incorporation of the scale as a primary endpoint in the upcoming study.

KL1333 continues to progress to Phase 2/3 study start

The readout of the Phase 1b study in mitochondrial disease patients during Q2 allowed us to return to the FDA in late July to confirm key aspects of the Phase 2/3 clinical design. The

meeting was collaborative and productive, and the feedback provided by the FDA confirmed that we will be able to move forward with two primary endpoints in the study, our mitochondrial disease-specific fatigue endpoint, as well as the functional assessment of 30-Second Sit to Stand. We will now be able to assess the impact of KL1333 on multiple aspects of the disease from fatigue to muscle weakness and endurance. In addition, if both endpoints are positive, it will give us a broader label for the approved medicine, meaning that more patients will be able to gain access to this important therapeutic.

Financing activities initiated

A major focus of Q3 has been initiating conversations with banks, investors and potential partners to raise the financing for the Phase 2/3 study of KL1333. We are also in tangible discussions with both specialist investors and industry players which

we hope will come to fruitful conclusions, as we aim to recruit the first patients as soon as possible in 2022.

NV354 towards clinical development

The team requested a meeting with the UK pharmaceutical regulatory authority, MHRA, in early September to discuss the NV354 preclinical package. In that meeting the MHRA agreed that the preclinical data package on NV354 supports dosing in a Phase 1 setting. The team will now assemble a clinical trial application for MHRA review as we work to dose our first healthy volunteer with NV354 in 2022.

Ellen Donnelly

CEO

Primary mitochondrial disorders are metabolic diseases that affect the cells' ability to convert energy. The diseases can manifest very differently depending on the organs affected. They have historically been viewed as clinical syndromes and more recently as disease spectra, caused by genetic defects affecting mitochondrial function. It is estimated that 125 persons

Primary mitochondrial diseases often present in early childhood and can lead to severe symptoms, such as stunted growth, muscle weakness, pronounced fatigue, heart failure and rhythm disturbances, diabetes, movement disorders, stroke-like episodes, deafness, blindness, limited mobility of the eyes and epilep-

PROJECT	DISEASE	DISCOVERY	PRECLINICAL	PHASE 1	PHASE 2/3	MARKET
KL1333*	PMD (mtDNA disorders)
NV354	PMD (Leigh syndrome)
Early programs	PMD

*Orphan drug designation in the US and Europe

PMD stands for Primary Mitochondrial Diseases, often referred to as 'mito disease'. mtDNA disorders are disorders caused by mutation(s) in mitochondrial DNA (as opposed to nuclear DNA).

Strategic Focus: Primary Mitochondrial Diseases (PMD)

Abliva is focused on becoming the leading biopharmaceutical company in mitochondrial medicine, developing therapeutics for primary mitochondrial diseases, orphan indications of high unmet medical need. The company will build a fully integrated research, development, and commercial organization, developing innovative therapeutics and taking them directly to the patients.

Building the Premier Mitochondrial Medicine Company

Abliva's long-term goal is to become the leading global biopharmaceutical company focused on the discovery of therapeutics for mitochondrial diseases. Abliva has the foundation to do this with a clear strategy, a strong portfolio of assets, a research organization and a team that has over two decades of experience in mitochondrial medicine as well as decades of experience in drug development.

Over the next five years we will focus on the delivery of our portfolio to the market. We will augment our strong research and development capabilities and build a commercial organization. We will bring new innovative therapeutics to the clinic and fuel our pipeline with new candidates from discovery. We will attract and retain talented colleagues with a passion for drug development. We will build a strong network of experts that will complement, enhance and support our efforts across development that will include patients, physicians, researchers, regulators, payers and technical experts. We will generate future revenues through two paths: sales revenue for the drugs Abliva intends to bring to market, and revenue from out-licensing assets (through milestone payments and royalties).

Addressing Primary Mitochondrial Diseases (PMD)

Mitochondria function as the powerhouses of our cells and are crucial for the cells' energy metabolism. PMD are rare orphan diseases where the energy metabolism in the cells is impaired, causing deterioration that leads to multifaceted disorders and great suffering for patients. The symptoms worsen over time

and, in many cases, the diseases lead to premature mortality. Mitochondrial medicine has become an area of increasing focus for the pharmaceutical industry as there are currently no effective treatment options for patients. Through Abliva's research and development, we have an opportunity to improve the quality of life for these patients.

Delivering a Portfolio of First-in-Class Therapies

Abliva's in-house R&D capabilities have been instrumental in creating and delivering a portfolio that includes several projects with mechanisms of action suitable for a wide range of PMDs.

KL1333 restores the balance of the coenzymes NAD+ and NADH, creating new mitochondria and improved energy levels. KL1333 has completed a number of key Phase 1 studies to prepare the asset for registrational Phase 2/3 study start in 2022. KL1333 is protected by both a composition of matter patent as well as Orphan Drug Designation (ODD) in the U.S. and in Europe. The commercial opportunity is significant with even conservative estimates exceeding USD 1 billion per year in annual sales.

NV354, an energy replacement therapy, is a pro-drug of succinate. The drug was invented in the Abliva laboratories at Lund University and is supported by a strong group of patents. NV354 is being developed for the PMD Leigh Syndrome initially with potential to expand to other PMD indications that have a dysfunctional complex I in the electron transport chain.

Additionally, Abliva has additional efforts ongoing in discovery that are focused on the regulation and stabilization of the mitochondrion's energy production.

Leveraging Opportunities in Rare Diseases

Abliva is continually working to take advantage of the opportunities afforded to companies working in the rare disease space. The company requested, and was granted, orphan drug designation (ODD) for KL1333 in both the US and EU. ODD is a regulatory designation that provides sponsors with a number of advantages including more regulatory assistance and scientific advice during the development process, lower development costs, attractive pricing, and market exclusivity (10 years in the EU and 7 years in the US). The outlook for reaching the market is also better than for traditional medicines1,2.

In addition, we have sought advice from pharmaceutical regulators in the US, UK and Europe. This advice has been extremely important to the company, as is clearly demonstrated with the advice from the FDA that led us to move to a single, registrational Phase 2/3 study (versus the traditional sequential Phase 2 followed by Phase 3 design), allowing us to get to market more quickly.

Building a World Class Organization

The key to the success of any company is the people who work there, and the leadership at Abliva is committed to attracting and retaining a group of bright, innovative scientists, clinicians, and drug development experts. We will continue to support development opportunities for our colleagues and ensure that they have the tools and resources available to deliver on our goals. We will continue to complement our core team with a network of specialists, physicians, advisors and others who will bring their expertise to our programs.

Accessing Capital to Finance the Vision

Abliva is a public company traded on NASDAQ Stockholm (ABLI, Small cap). The company appreciates the continued commitment of our shareholders and looks to attract new investors as we advance our portfolio and build the company. The investment of Hadean Ventures was the first step to bringing specialist investors into the company and the company aims to continue to attract new specialist and institutional investors across Sweden, Europe and America as the financial needs of the company increase with the KL1333 registrational study, the progression of the portfolio, and the build of a commercial organization.

KL1333 Blockbuster candidate heading to registrational Phase 2/3 study

Phase 1a/b study: Positive safety results and signs of efficacy Registrational Phase 2/3 study planned to recruit the first patient in 2022 Orphan drug designation in both the United States and Europe

Events in the third quarter

• The study to create a primary mitochondrial disease fatigue endpoint for use in the KL1333 Phase 2/3 study was completed.
• The first chronic toxicology study (six months) was completed.

Objectives for 2021

• Complete the Phase 1a/b study and report results. ✓ Complete the drug-drug interaction study and report results. ✓ Preparatory activities for the Phase 2/3 study:
• conduct a patient registry study ✓
• conduct a validation study of endpoints ✓
• initiate chronic toxicology studies ✓ Initiate registrational Phase 2/3 study.

KL1333 is being developed as a treatment for a subset of adult primary mitochondrial disease patients suffering from multiple debilitating symptoms, including mitochondrial fatigue and myopathy. Diagnoses can include MELAS-MIDD and KSS-CPEO spectrum disorders as well as MERRF syndrome.

The drug candidate is intended for long-term oral treatment.

DISEASE AREA PATH TO MARKET

The recommendation from the FDA to make a coherent, registrational Phase 2/3 study brings significant benefits to the KL1333 project, and Abliva's intention is to apply for market approval during 2024. The number of patients in the target group for treatment with KL1333 is approximately 40,0001) in Europe and the US. At typical orphan drug pricing, this translates into a blockbuster opportunity.

1) Gorman e tal.,Prevalence of Nuclear and Mitochondrial DNA Mutations Related to Adult Mitochondrial Disease, 2015

KL1333 has the ability to restore the balance of NAD+ and NADH, and thus leads to the formation of new mitochondria and improved energy levels.

NV354 First-in-class therapeutic heading towards clinical development

Positive feedback from UK MHRA Clinical Phase 1 study planned to commence in 2022

Events in the third quarter

• Favorable feedback was received from UK regulators (MHRA) on the NV354 preclinical data package.
• The planned preclinical pharmacology and safety studies were completed.

Objectives for 2021

- Complete preclinical pharmacology and safety studies ✓ Produce NV354 clinical trial material for clinical studies.

• Complete regulatory documentation to support clinical entrance.

PRIMARY INDICATION

NV354 is being developed for the treatment of Leigh syndrome, a severe primary mitochondrial disease that usually debuts at one to two years of age. The disease is fatal and children usually die before age 5.

Symptoms include developmental delay, psychomotor regression and hypotonia. There are currently no approved medicines. The drug candidate is intended for long-term oral treatment.

EXPANSION OPPORTUNITY

The unique mechanism of action and high brain uptake may be utilized to develop NV354 for the treatment of MELAS in children and adolescents with neurological symptoms, and for the treatment of LHON. MELAS is a serious disease with symptoms such as muscle weakness, diabetes, fatigue, epilepsy, other severe neurological effects, and shortened life span. LHON is a disease that causes sudden severe permanent visual impairment and can lead to blindness on both eyes.

In Leigh syndrome, the first step in energy formation does not work. NV354 restores the energy needed in the diseased mitochondria.

PATH TO MARKET

25 per 1,000,000 children are estimated to be born with Leigh syndrome. MELAS and LHON could also be treated with NV354. There are approximately 25,000 people with LHON in Europe.1)

1 Gorman et al., Prevalence of Nuclear and Mitochond- rial DNA Mutations Related to Adult Mitochondrial Disease, 2015

Non-core asset

The company is seeking a strategic partner for the continued development of NeuroSTAT. It has initiated preliminary discussions with the TRACK-TBI network on a potential collaboration for a Phase 2 traumatic brain injury study with NeuroSTAT under the Precision Medicine project1) 2) funded by the U.S. Department of Defense.

NEUROSTAT – FOR TREATMENT OF TBI

Traumatic brain injury (TBI) is caused by external force to the head resulting in immediate damage to nerve cells. The damage continues to worsen for several days after the acute trauma.

Treatment objective

The aim for NeuroSTAT, targeting the mitochondria, is to counteract the emergence of neurological and functional secondary brain damage after a traumatic injury, and thereby establish a therapy that will lead to increased survival, improved quality of life and preserved neurological function.

Project status

NeuroSTAT has shown favorable properties in a Phase 1b/IIa clinical study and in advanced experimental TBI models at the University of Pennsylvania (Penn). NeuroSTAT has orphan drug designation in Europe and the US as well as an IND approval and Fast Track designation for clinical development in the US.

Abliva continues in preliminary discussions with the TRACK- TBI network regarding a potential collaboration within the scope of the Precision Medicine project1) 2) for a Phase 2 study on traumatic brain injury with NeuroSTAT. The study, if authorized by US Department of Defense (DOD), would commence in 2022,

contingent upon DOD's approval of earlier steps of the project. With a potential agreement with TRACK-TBI as a partner, the company will review possible options that may enable developing the NeuroSTAT program further.

¹ Precision Medicine grant: TRACK-TBI Precision Medicine is a DOD-funded project run by the leading traumatic brain injury (TBI) clinical trial network TRACK-TBI in the US. The aim of the project is to validate novel imaging and blood -based biomarkers for moderate/ severe TBI to enable precision medicine TBI clinical trials with a focus on specific disease pathologies and enriched study populations.

² The views expressed regarding the Precision Medicine project are those of the company/authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.

Consolidated Statement of

Comprehensive Income

Revenues

The consolidated turnover during the third quarter of 2021 was SEK 85,000 (0,000). Other operating revenues for the third quarter were SEK 0,000 (63,000) and pertainen in 2021 to exchange-rate gains and compensation for sixk pay. During the first nine months of 2021 the consolidated turnover was SEK 103,000 (105,000) SEK. Other operating revenues for the first nine months amounted SEK 0,000 (45,000) SEK.

Results of operations

The operating loss for the third quarter was SEK 34,851,000 (10,070,000) and for the first nine months the operating loss amounted SEK -86,613,000 (-46,902,000). The net loss before tax for the third quarter amounted to SEK 34,854,000 (-10,078,000). For the fist nine months the loss before tax was -86,624,000 (-46,927,000).

The operating loss was affected by other external expenses, which for the first nine months were SEK 70,381,000 (34,606,000). Increased external costs relates primarily to preparing and start-up activities in the KL1333 project. Expenses related to development projects, as a part of external expenses, have affected the result with SEK 60,687,000 (21,256,000) whereof SEK 56,356,000 (15,722,000) relates to project in clinical phase. Personnel expenses during the first nine months amounts to KSEK 13,899,000 (10,506,000) including notice period and severance pay to former CEO of SEK 2,881,000. Other operating expenses amount to, SEK 456,000 (26,000) and pertains to exchange-rate losses.

	1 Jul, 2021	1 Jul, 2020	1 Jan, 2021	1 Jan, 2020	1 Jan, 2020
(SEK 000) Note		30 Sep, 2021 30 Sep, 2020 30 Sep, 2021 30 Sep, 2020 31 Dec, 2020
Net sales	85	-	103	105	216
Other operating income	-	63	-	45	1,648
Operating expenses	85	63	103	150	1,864
Other external expenses	-30,688	-6,760	-70,381	-34,606	-46,072
Personnel cost	-3,400	-2,722	-13,899	-10,506	-13,305
Depreciation and write-down of tangible and intangible assets	-663	-651	-1,980	-1,914	-2,558
Other operating expenses	-186	-	-456	-26	-
	-34,936	-10,133	-86,716	-47,052	-61,935
Operating income	-34,851	-10,070	-86,613	-46,902	-60,071
Profit/loss from financial items
Result from other securities and receivables related to non current assets	-	-	-	-	107
Financial costs	-2	-8	-10	-24	-30
	-2	-8	-10	-24	77
Profit/loss before tax	-34,854	-10,078	-86,624	-46,927	-59,994
Income tax 2	-	-	-	-	-
Profit/loss for the period	-34,854	-10,078	-86,624	-46,927	-59,994
Other comprehensive income
Items that may be reclassified to profit or loss
Translation differences on foreign subsidiaries	13	-0	11	-1	-3
Total comprehensive income for the period	-34,841	-10,078	-86,613	-46,928	-59,997
Loss for the period attributable to:
Parent company shareholders	-34,853	-10,078	-86,622	-46,926	-59,989
Non-controlling interests	0	-	-2	-1	-5
	-34,854	-10,078	-86,624	-46,927	-59,994
Total comprehensive income for the period
Parent company shareholders	-34,840	-10,078	-86,612	-46,927	-59,992
Non-controlling interests	0	-	-2	-1	-5
	-34,841	-10,078	-86,613	-46,928	-59,997
Earnings per share before and after dilution(SEK) based on average number of shares	-0.09	-0.03	-0.24	-0.20	-0.24
Average number of shares before and after dilution		403,006,798 293,969,762 359,221,764 234,981,562 250,321,204

Consolidated Statement of

Financial Position

Financial position

The equity/assets ratio was 78 (92) percent as of 30 September 2021, and equity was SEK 77,957,000 (101,725,000). The equity includes funds from the in April and May completed two tranches directed share issue, which provided the company with SEK 75,900,000 after deduction of issue costs of SEK 4,100,000. Short term Liabilties amounted SEK 21,946,000 (8,954,000) as of 30 September 2021, the increase is mainly related to prepatory activities in the KL1333 phase 2/3 study. Cash and cash equivalents amounted to SEK 63,267,000 (73,188,000) as of 30 September 2021, an increase of SEK 1,624,000 from the beginning of the year. Total assets as of 30 September 2021 were SEK 99,903,000 (110,771,000).

The board continuously monitors and evaluates the company's funding need and financial position. The board has initiated a process to ensure adequate funding to enable the start of a pivotal Phase 2/3 study in the company's KL1333 project during 2022.

Financial instruments

Abliva holds unlisted securities. These assets should be measured at fair value and are classified as "financial assets measured at fair value through other comprehensive income."

The holding corresponds to 10% in one of Abliva's R&D partner companies, which conducts development activities. A prudent assessment is that book value corresponds to the market value.

Other financial assets and liabilities are valued at amortized cost. The carrying amount of these assets and liabilities is estimated to correspond to fair value.

(SEK 000)	Note		30 Sep, 2021 30 Sep, 2020 31 Dec, 2020
ASSETS
Non-current assets
Intangible assets	1
Development costs*		-	-	-
Patents		20,303	21,194	20,971
Other Intangible assets		1,243	1,378	1,344
		21,546	22,572	22,315
Tangible assets
Equipment		71	53	41
Rigth of use asset leases		86	429	343
		157	483	384
Financial assets
Other long-term securities		13,101	13,101	13,101
		13,101	13,101	13,101
Total non-current assets		34,804	36,155	35,800
Current assets
Other receivables		1,088	1,101	928
Prepaid expenses and accrued income		743	327	586
Cash and cash equivalents		63,267	73,188	61,643
		65,099	74,616	63,157
TOTAL ASSETS		99,903	110,771	98,957

*Capitalized Development Costs

The Board of Swedish Accounting Supervision examined the Company's interim report as of September 30, 2020 and the Annual report for 2020 regarding the accounting of capitalized development costs, and referred the case to Finansinspektionen (FI). In October FI announced that they would investigate whether Abliva AB complied with the regulations for accounting in its annual and consolidated accounts for 2020. More specifically, whether Abliva AB had violated the provisions of Article 4 of the European Parliament and Council Regulation (EC) No 1606/2002 of 19 July 2002 on the application of international accounting standards, and the Annual Accounts Act (1995: 1554) regarding the accounting of development expenses as an intangible asset. As an adaptation to the The Board of Swedish Accounting Supervision's view on the handling of capitalized development costs (IAS 38), the Board has made a correction of Opening balances 1 January 2020 in Equity, in accordance with IAS 8 Accounting Policies, Changes in Accounting Estimates and Errors. The total adjustment of SEK 51,706,000 refers to accumulated capitalized development costs related to the NeuroSTAT program processed up to and including 31 March 2017

Financial Position

Consolidated Statement of	(SEK 000)	Note		30 Sep, 2021 30 Sep, 2020 31 Dec, 2020
	EQUITY AND LIABILITIES
Financial	Equity attributable to the shareholders of the parent company
	Share capital		20,150	14,817	14,817
Position	Additional paid in capital		730,592	660,025	660,025
	Translation reserve		627	618	616
	Retained earnings*		-673,424	-573,739	-586,802
	Total equity attributable to the shareholders of the parent		77,944	101,721	88,656
	Non-controlling interests		13	4	-
	Total equity		77,957	101,725	88,656
	Long-term liabilities
	Other longtrem liabilities		-	92	92
			-	92	92
	Short-term liabilities
	Accounts payable		15,587	1,736	4,201
	Other liabilities		359	742	675
	Accrued expenses and deferred income		5,999	6,476	5,333
			21,946	8,954	10,209
	Total liabilities		21,946	9,138	10,392
	TOTAL EQUITY AND LIABILITIES		99,903	110,771	98,957

*Retained earnings

For further information, see page 10, *Capitalized Development Costs.

Consolidated Statement of

Changes in Equity

*Total equity includes funds from the April 6, 2021 and May 4th completed directed share issue with SEK 75,900,000 less expenses SEK 4,100,000.

** The adjustment pertains to development costs, for further information, see page 10, *Capitalized Development Costs.

	Equity attributable to the shareholders of the parent company
	Additional					Non-
	Share-		paid in Translation	Retained		controlling	Total
(SEK 000)	capital	capital	reserve	earnings	Total	interests	equity
Opening balance, 1 January 2020	9,298	592,980	619	-475,107	127,791	5	127,795
Retroactive adjustment of capitalized development costs**	-	-	-	-51,706	-51,706	-	-51,706
Restated total equity at the beginining of the year	9,298	592,980	619	-526,813	76,084	5	76,089
Comprehensive profit/loss for the period
Profit/loss for the period	-	-	-	-46,926	-46,926		-46,927
Other comprehensive income
Translation differences	-	-	-1	-	-1	-	-1
Other comprehensive profit/loss for the period, net after tax	-	-	-1	-	-1	-	-1
Total comprehensive profit/loss	-	-	-1	-46,926	-46,927	-1	-46,928
Transactions with shareholders
Rights Issue*	5,519	67,045	-	-	72,564	-	72,564
Total transactions with shareholders	5,519	67,045	-	-	72,564	-	72,564
Closing balance, 30 September 2020	14,817	660,025	618	-573,739	101,721	4	101,725
Opening balance, 1 January 2020	9,298	592,980	619	-475,107	127,791	5	127,795
Retroactive adjustment of capitalized development costs**	-	-	-	-51,706	-51,706	-	-51,706
Restated total equity at the beginining of the year	9,298	592,980	619	-526,813	76,084	5	76,089
Comprehensive profit/loss for the period	-	-	-	-	-	-	-
Profit/loss for the period	-	-	-	-59,989	-59,989	-5	-59,994
Other comprehensive income	-	-	-	-	-	-	-
Translation differences	-	-	-3	-	-3	-	-3
Other comprehensive profit/loss for the period, net after tax	-	-	-3	-	-3	-	-3
Total comprehensive profit/loss	-	-	-3	-59,989	-59,992	-5	-59,997
Transactions with shareholders	-	-	-	-	-	-	-
Rights Issue	5,519	67,045	-	-	72,564	-	72,564
Total transactions with shareholders	5,519	67,045	-	-	72,564	-	72,564
Closing balance, 31 December 2020	14,817	660,025	616	-586,802	88,656	0	88,656
Opening balance, 1 January 2021	14,817	660,025	616	-586,802	88,656	0	88,656
Comprehensive profit/loss for the period
Profit/loss for the period	-	-	-	-86,622	-86,622	-2	-86,624
Other comprehensive income
Translation differences	-	-	11	-	11	-	11
Other comprehensive profit/loss for the period, net after tax	-	-	11	-	11	-	11
Total comprehensive profit/loss	-	-	11	-86,622	-86,612	-2	-86,613
Transactions with shareholders
Rights Issue*	5,333	70,567	-	-	75,900	-	75,900
Shareholder contribution	-	-	-	-	-	14	14
Total transactions with shareholders	5,333	70,567	-	-	75,900	14	75,914
Closing balance, 30 September 2021	20,150	730,592	627	-673,424	77,944	13	77,957

Consolidated Statement of Cash Flows

Cash flow and investments

Operating cash flow for the second quarter was SEK -30,307,000 (-14,182,000). For the first nine months the operating cash flow amounted SEK -73,297,000 (-56,511,000). The cash flow effect related to investments in intangibles equals SEK -841,000 (-1,088,000) for the first nine months. Cash flow for the third quarter equals SEK -30,881,000 (3,907,000). Cashflow for the first nine months equals SEK 1,618,000 (14,697,000).

(SEK 000)	1 Jul, 2021	1 Jul, 2020	1 Jan, 2021	1 Jan, 2020	1 Jan, 2020
				30 Sep, 2021 30 Sep, 2020 30 Sep, 2021 30 Sep, 2020 31 Dec, 2020
Cash flow from operating activities
Operating income	-34,851	-10,070	-86,613	-46,902	-60,071
Adjustments for non-cash items:
Depreciation	663	651	1,980	1,914	2,558
Currency differences on intercompany items	13	-	6	-	-
Result from other securities and receivables related to non current assets	-	-	-	-	107
Interest received	-	-	-	-	-
Interest paid	-2	-8	-10	-24	-30
Net cash from operating activities before changes in working capital	-34,177	-9,426	-84,637	-45,013	-57,436
Changes in working capital
Increase/decrease of other current assets	456	1,590	-317	172	86
Increase/decrease of other short-term liabilities	3,414	-6,345	11,658	-11,670	-10,208
Changes in working capital	3,870	-4,755	11,341	-11,498	-10,122
Cash flow from operating activities	-30,307	-14,182	-73,297	-56,511	-67,558
Investing activities
Acquisition of intangible assets	-573	-283	-841	-1,088	-1,407
Acquisition of tangible assets	-	-	-65	-	-
Increase in other financial assets	-	-	-	-	-
Cash flow from investing activities	-573	-283	-907	-1,088	-1,407
Financing activities
Shareholder contribution subsidiary	-	-	14	-	-
New share issue	-	18,467	75,900	72,564	72,564
Amoritization lease	-	-95	-92	-269	-269
Cash flow from financing activities	-	18,371	75,822	72,295	72,295
Cash flow for the period	-30,881	3,907	1,618	14,697	3,330
Cash and cash equivalents at the beginning of the period	94,146	69,109	61,643	58,319	58,319
Effect of exchange rate changes on cash	2	-3	7	-3	-6
Cash and cash equivalents at end of period	63,267	73,013	63,267	73,013	61,643

Parent Company Income Statement

Parental company

Company earnings after tax for the third quarter amounts to SEK -32,808,000 (-10,087,000). Earnings after tax for the first nine months amount to KSEK -83,345,000 (-46,916,000). Most of the Group's operations are conducted within the parent company. Accordingly, no further specific information regarding the parent company is presented.

Parent Company

Statement of Comprehensive Income

(SEK 000)		1 Jul, 2021	1 Jul, 2020	1 Jan, 2021	1 Jan, 2020	1 Jan, 2020
					Note 30 Sep, 2021 30 Sep, 2020 30 Sep, 2021 30 Sep, 2020 31 Dec, 2020
Net sales		85	-	103	105	216
Other operating income		-	52	-	45	1,648
		85	52	103	150	1,864
Operating expenses
Other external expenses		-30,706	-6,850	-70,521	-34,878	-46,411
Personnel cost		-1,423	-2,722	-10,749	-10,506	-13,305
Depreciation and write-down of tangible and intangible assets		-577	-566	-1,722	-1,656	-2,215
Other operating expenses		-186	-	-456	-26	-
		-32,892	-10,138	-83,448	-47,066	-61,931
Operating income		-32,808	-10,086	-83,345	-46,916	-60,067
Profit/loss from financial items
Result from other securities and receivables related to non current assets		-	-	-	-	107
Interest expenses and other similar loss items		-	-1	-	-1	-1
		-	-1	-	-1	106
Profit/loss before tax		-32,808	-10,087	-83,345	-46,917	-59,961
Income tax	2	-	-	-	-	-
Profit/loss for the period		-32,808	-10,087	-83,345	-46,917	-59,961

(SEK 000)	1 Jul, 2021	1 Jul, 2020	1 Jan, 2021	1 Jan, 2020	1 Jan, 2020
				Note 30 Sep, 2021 30 Sep, 2020 30 Sep, 2021 30 Sep, 2020 31 Dec, 2020
Profit/loss for the period	-32,808	-10,087	-83,345	-46,917	-59,961
Other comprehensive income	-	-	-	-	-
Total comprehensive profit/loss for the period	-32,808	-10,087	-83,345	-46,917	-59,961

Parent Company Balance Sheet

(SEK 000) Note		30 Sep, 2021 30 Sep, 2020 31 Dec, 2020
ASSETS
Non-current assets
Intangible assets 1
Development costs*	-	-	-
Patents	20,303	21,194	20,971
Other intangible assets	1,243	1,378	1,344
	21,546	22,572	22,315
Tangible assets
Equipment	71	53	41
	71	53	41
Financial assets
Other long-term placement	13,101	13,100	13,101
Shares in subsidiaries 3	24,558	23,625	23,625
	37,659	36,726	36,726
Total non-current assets	59,276	59,351	59,082
Current assets
Short term receivables
Receivables from group companies	1,192	-	-
Other receivables	1,154	1,098	926
Prepaid expenses and accrued income	656	327	585
	3,002	1,425	1,511
Cash and bank balances	63,012	73,163	61,634
Total current assets	66,014	74,587	63,145
TOTAL ASSETS	125,290	133,938	122,226

*Development costs.

The Board of Swedish Accounting Supervision examined the Company's interim report as of September 30, 2020 and the Annual report for 2020 regarding the accounting of capitalized development costs, and referred the case to Finansinspektionen (FI). In October FI announced that they would investigate whether Abliva AB complied with the regulations for accounting in its annual and consolidated accounts for 2020. More specifically, whether Abliva AB had violated the provisions of Article 4 of the European Parliament and Council Regulation (EC) No 1606/2002 of 19 July 2002 on the application of international accounting standards, and the Annual Accounts Act (1995: 1554) regarding the accounting of development expenses as an intangible asset. As an adaptation to the The Board of Swedish Accounting Supervision's view on the handling of capitalized development costs (IAS 38), the Board has made a correction of Opening balances 1 January 2020 in Equity, in accordance with IAS 8 Accounting Policies, Changes in Accounting Estimates and Errors. The total adjustment of SEK 51,706,000 refers to accumulated capitalized development costs related to the NeuroSTAT program processed up to and including 31 March 2017

Parent Company Balance Sheet EQUITY AND LIABILITIES

(SEK 000) Note		30 Sep, 2021 30 Sep, 2020 31 Dec, 2020
Equity
Restricted equity
Share capital	20,150	14,817	14,817
Statutory reserve	1,856	1,856	1,856
Development expenditure reserve**	3,153	4,044	3,821
	25,159	30,472	30,249
Unrestricted equity
Share premium reserve	137,611	170,111	67,045
Retained earnings*	25,431	-18,565	84,725
Profit/loss for the period	-83,345	-46,917	-59,961
	79,697	94,874	82,053
Total equity	104,857	125,346	112,302
Short-term liabilities
Accounts payable	15,544	1,736	4,201
Other liabilities	254	386	406
Accrued expenses and deferred income	4,635	6,470	5,317
	20,433	8,592	9,924
TOTAL EQUITY AND LIABILITIES	125,290	133,938	122,227

*Retained earnings

For further information, see page 15, *Development costs.

**Development expenditure reserve.

As a consequence of restroactive adjustments related to capitalized development costs, an adjustment of the Development expenditure reserve has been implemented in the Parent company of in total SEK 9,755,000 regarding accumulated capitalized development costs, which means that the new opening balance Development expenditure reserve as of January 1, 2020 amounts to SEK 4,351,000. Opening balance 1 January 2020 before adjustment was 14,106,000. The adjustment has been recorded against retained earnings and the net effect on equity is zero.

Notes Note 1 — Intangible assets

(SEK 000)	Development costs	Patents	Other	Total
ACCUMULATED COST
Opening balance 1 Jan. 2021	-	33,771	2,864	36,635
Additions	-	918	-	918
Closing balance 30 Jun. 2021	-	34,689	2,864	37,553
ACCUMULATED DEPRECIATION
Opening balance 1 Jan. 2021	-	-12,800	-1,519	-14,319
Depreciation for the period	-	-1,586	-102	-1,688
Closing balance 30 Jun. 2021	-	-14,386	-1,621	-16,007
Residual value 30 Jun. 2021	-	20,303	1,243	21,546

(SEK 000)	Development costs	Patents	Other	Total
ACCUMULATED COST
Opening balance 1 Jan. 2020	51,706	32,279	2,864	86,849
Retroactive adjustment of capitalized development costs*	-51,706	-	-	-51,706
Restated Opening Balance 1 Jan 2020	-	32,279	2,864	35,143
Additions	-	1,492	-	1,492
Closing balance 31 Dec. 2020	-	33,771	2,864	36,635
ACCUMULATED DEPRECIATION
Opening balance 1 Jan. 2020	-	-10,778	-1,385	-12,163
Retroactive adjustment of capitalized development costs*	-	-	-	-
Restated Opening Balance 1 Jan 2020	-	-10,778	-1,385	-12,163
Depreciation for the period	-	-2,022	-134	-2,156
Closing balance 31 Dec. 2020	-	-12,800	-1,519	-14,319
Residual value 31 Dec. 2020	-	20,971	1,345	22,315

Note 2 – Tax

The group's total loss carry-forwards amounts to SEK 761,613,000 as of 30 September 2021 (657,606,000). The parent company's total loss carry-forwards amounts to SEK 732,476,000 as of 30 September 2021 (631,771,000). Because the company is loss making, management cannot judge when deductible loss carry-forwards will be utilized.

*Retroactive adjustment of capitalized development costs. For further information, see page 10, Capitalized Development Costs.

Note 3 – Shares and participations in group companies

These shares are the holding of 82.47% in the subsidiary NeuroVive Pharmaceutical Asia Ltd., domiciled in Hong Kong, the wholly-owned American subsidiary Abliva Inc., registered in March 2021 and the Swedish subsidiary Abliva Incentive AB, registered in May 2021, holding option program for the CEO.

Other disclosures

Transactions with related parties

Transactions between the company and its subsidiarie, which are related parties to the company, have been eliminated on consolidation, and accordingly, no disclosures are made regarding these transactions.

(SEK 000)	1 Jan.2021- 30 Sep. 2021	1 Jan.2020- 31 Dec. 2020
Eskil Elmér, CSO	-	6
Magnus Hansson, CMO	-	4
Total	-	10

No compensation based on sales has been paid during the period under the agreement, in relation to mitochondrial energy regulation projects, with the Research Group at Lund University, which includes CSO Eskil Elmér and CMO Magnus Hansson. During the period no transactions with related parties have occured.

Segment information

Financial information reported to the chief operating decision maker (CEO) as the basis for allocating resources and judging the group's profit or loss is not divided into different operating segments. Accordingly, the group consists of a single operating segment.

Human resources

The average number of employees of the group for the period January to September 2021 was 8 (9), of which 6 (5) are women.

Incentive programs/share warrants

The AGM on May 20, 2021, decided on a four-year incentive stock option program 2021/2025 for the Company's CEO. The incentive stock option program entitles the holder to a new ordinary share in Abliva AB up to a maximum of 4,600,000 ordinary shares. The redemption price amounts to 0.725 öre. The program is vested at 25% per year on June 1, 2022, June 1, 2023, June 1, 2024 and June 1, 2025. Latest redemption date is December 31, 2025.

The cost of the program has been calculated in accordance with IFRS2. No costs in the form of social security contributions are expected to arise. The total estimated accounting cost of the program amounts to a total of approximately SEK 1.5 million during the period 2021-2025 based on the actual value of the options at the time of calculation. The options do not have a market value since they are not transferable. The theoretical value of the options is approximately SEK 0.32 per option according to the Black @ Scholes formula. The total cost of the option program is distributed over the vesting period

Audit review

This Interim Report has been subject to review by the company's auditors in accordance with the Standard on Review Engagements (ISRE) 2410, Review of Interim Financial Information Performed by the Independent Auditor of the Entity.

Upcoming financial statements

Year-End Report 2021 February 22, 2022 Q1 Report January-March 2022 May 20, 2022 Q2 Report January-June 2022 August 19, 2022 Q3 Report January-September 2022 November 22, 2022 Year-End Report 2022 February 21, 2023

The interim reports and the Annual Year Report are available at www.abliva.com

Annual General Meeting 2022

Abliva's Annual General Meeting will be held at Medicon Village, Scheeletorget 1, in Lund, on Wednesday 27 April 2022 at 4 p.m.

The Nomination Committee for the 2022 AGM comprises:

• Florian Eckhardt for Hadean Ventures
• Kristina Ingvar for John Fällström
• Andreas Inghammar for Rothesay Ltd

In total, the Nomination Committee represents some 23.7 % of the votes in Abliva as of 30 September 2021.

The Nomination Committee's task ahead of the AGM 2022 is to prepare proposals on the following matters to present to the AGM for resolution:

-Propose the Chairman of the AGM -Propose the number of Board members -Propose remuneration to Board members and remuneration to Committee members

-Propose remuneration to the Auditors

-Propose the Chairman of the Board, other Board members and Auditor

-Propose guidelines for appointing members of the Nomination Committee and instructions for the Nomination Committee -Propose remuneration to the members of the Nomination Committee

Shareholders wishing to make proposals on the above matters can contact the Committee by email at: valberedningen@abliva. com, or by post at: Abliva AB, FAO: Nomination Committee, Medicon Village, 223 81 Lund, Sweden.

In order for the Nomination Committee to consider the proposals received with due care, proposals should be received by the Nomination Committee by no later than 4 February 2022.

Risks and uncertainty factors

A research company such as Abliva AB (publ) is subject to high operational and financial risks because the projects the company conducts are in different developmental phases, where a number of parameters influence the likelihood of commercial success. Briefly, operations are associated with risks relating to factors including drug development, competition, technological progress, patents, regulatory requirements, capital requirements, currencies and interest rates. The Board of Directors works continuously to secure the business operation's need for financing.

Financing

The Board continuously monitors and evaluates the company's funding need and financial position. The main project KL1333 is about to start a registrational Phase 2/3 study, the prerequisite for starting the study is financing for the entire study. If the company does not succeed in funding the KL1333 program there will be a delay and modification of the program.

Impact of COVID-19 on the Company's clinical trials

COVID-19 may, among other things, lead to delays in the Company's clinical studies, but it is currently difficult to assess all the potential effects that COVID-19 may have on the Company. Due to COVID-19, there is a risk of further delays because healthcare authorities and healthcare providers re-prioritize available resources, care locations and healthcare professionals to better meet the influx of COVID-19 patients. There is a risk that the start of the upcoming phase 2/3 study, which is expected to begin in 2022, will be further delayed due to Covid 19. The company's second drug candidate, which is being prepared for a phase 1 study in 2022, also risks being delayed due to the Covid 19 pandemic.

Abliva is not involved in any disputes.

For more detail of risks and uncertainty factors, refer to the Statutory Administration Report in the Annual Report 2020 and the prospectus published April 30, 2021.

Principles of preparation of the Interim Report

Abliva prepares its consolidated accounts in accordance with International Financial Reporting Standards (IFRS) issued by the International Accounting Standards Board (IASB) and interpretation statements from the IFRS Interpretations Committee, as endorsed by the EU for application within the EU. This Interim Report has been prepared in accordance with IAS 34 Interim Financial Reporting.

TThe parent company applies the Swedish Annual Accounts Act and RFR's (the Swedish Financial Reporting Board) recommendation RFR 2 Accounting for Legal Entities. Application of RFR 2 implies that, as far as possible, the parent company applies all IFRS endorsed by the EU within the limits of the Swedish Annual Accounts Act and the Swedish Pension Obligations Vesting Act,

and considering the relationship between accounting and taxation.

The group and parent company have applied the accounting principles described in the Annual Report for 2020 on pages 46-61.

Definitions alternative performance measures

Alternative Performance Measures (APM) are key figures not defined in financial reports prepared according to IFRS. Of the below key figures, only the key figure Earnings per share before and after dilution is mandatory and defined according to IFRS. Of the other key figures, net sales, earnings per share before and after dilution, cash flow from operating activities and cash flow for the period are defined according to IFRS.

The following key figures are used:	Definition	Reason for use
Net revenues	Revenue from goods and services sold that are part of the company's normal operations
Other operating income	Income from secondary activities in ordinary activities such as grants received
Operating income	Net sales and other revenues minus expenses for other external costs, personnel costs, depreciation and impairment and other expenses	Measures the result in the operations
Profit/loss before tax	Operating income after profit/loss from finacial items and allocations	Measures the result in the business after profit/loss from financial items and allocations
Earnings per share before dilution(SEK) based on average number of shares	Profit/loss for the period divided by average number of shares before dilution at the end of the period
Earnings per share after dilution(SEK) based on average number of shares	Profit/loss for the period divided by average number of shares after dilution at the end of the period
Cash flow from operating activities	Cash flow from operating activities, including cash flow from working capital, ie changes in current liabilities and current receivables	Measures total cash flow generated in the business
Cash flow for the period	The company's total cash flow from operating activities, investment activities and financing activities	Measures total cash flow generated in the business including investment activities and financing activities
Average number of shares before and after dilution	Average number of shares before and after dilution	Measures the average number of shares during the period before and after dilution. As the Group's earnings are negative, there is no dilution
Equity Ratio %	Equity as a percentage of total assets	Shows how much of the company's assets are financed with equity and shows the company's ability to pay
Liquidity Ratio (%)	Current assets divided by current liabilities	Shows on the company's short-term ability to pay

The declaration of the Board of Directors and the CEO

This Interim Report gives a true and fair view of the parent company and group's operations, financial position and results of operations, and states the significant risks and uncertainty factors facing the parent company and group companies.

Lund, Sweden, 19 November, 2021

David Laskow-Pooley David Bejker Roger Franklin

Chairman of the Board Board member Board member

Denise Goode Jan Törnell Ellen Donnelly

Board member Board member Chief Executive Officer

For more information concerning this report, please contact CEO Ellen Donnelly. Telephone: +46 (0)46-275 62 20.

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CET on 19 November, 2021.

This Interim Report is published in Swedish and English. In the event of any difference between the English version and the Swedish original, the Swedish version shall prevail.

Auditor's review report

TO THE BOARD OF ABLIVA AB (PUBL), CORP.ID.NO 556595-6538

Introduction

We have reviewed the condensed interim report for Abliva AB (publ) as at September 30, 2021 and for the nine months period then ended. The Board of Directors and the Managing Director are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.

Scope of review

We conducted our review in accordance with the International Standard on Review Engagements, ISRE 2410 Review of Interim Financial Statements Performed by the Independent Auditor

of the Entity. A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing and other generally accepted auditing standards in Sweden.

The procedures performed in a review do not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material aspects, in accordance with IAS 34 and the Swedish Annual Accounts Act regarding the Group, and in accordance with the Swedish Annual Accounts Act regarding the Parent Company.

Malmö, November 19, 2021 Ernst & Young AB

Ola Larsmon

Authorized Public Accountant

Glossary

Active compound. A pharmaceutical active ingredient in a pharmaceutical product.

Candidate drug. A particular compound which is selected during the preclinical phase. The candidate drug is subsequently tested in humans in clinical studies.

Clinical study. The examination of healthy or unhealthy humans to study the safety and efficacy of a pharmaceutical or treatment method. Clinical trials are divided into different phases, termed Phase 1, Phase 2, Phase 3. Phase 2 is usually divided into an early phase (Phase 2a) and a later phase (Phase 2b). See also "phase (1,2 and 3)".

Drug-drug interaction study. A clinical study in healthy volunteers to investigate the drug-drug interactions when co-administering a (candidate) drug with other drugs. Drug-drug interactions can lead to changed systemic exposure, resulting in variations in drug response of the co-administered drugs.

Fatigue. Extreme tiredness. Often includes muscle fatigue with exercise intolerance.

FDA. The United States Federal Food and Drug Administration.

Hypotonia. An abnormally low level of tension, important for posture, in the resting muscle.

Indication. A disease condition requiring treatment, such as traumatic brain injury or fatty liver, NASH.

In vivo/in vitro. In vivo are scientific studies in animal models. In vitro are scientific studies carried out outside of the living body, for example in cells in test tubes.

KSS. Mitochondrial disease, Kearns-Sayre's syndrome. The disease debuts before the age of 20 and is characterized by eye related symptoms with pigment retention in the retina and paralysis of the outer eye muscles, as well as the effects on the cardiac retinal system and the cerebellum with disorders in the coordination of muscle movements (ataxia).

Leigh syndrome. Leigh syndrome is a serious condition with characteristic changes to the brain that usually affects small children. This disease is caused by faults in energy-producing mitochondria and is also known as subacute (fast onset) necrotizing (tissue destroying) encephalomyopathy (a disease of the brain and muscles).

LHON. Mitochondrial disease, Leber Hereditary Optic Neuropathy. Affects the retina and the optic nerve, but in rare cases symptoms can be found in other parts of the central nervous system. There is no cure, but treatments are focused primarily on compensating for the visual impairment.

Liver fibrosis/cirrhosis. Liver fibrosis is the formation of fibrous tissue (scar tissue) in the liver as a result of, for example, infection. May lead to liver cirrhosis.

MELAS. MELAS is an acronym of mitochondrial encephalomyopathy (brain and muscle disease) with lactic acidosis (increased lactic acid levels in the blood) and strokelike episodes.

MERRF. (Myoclonic epilepsy with ragged-red fibers). Primary mitochondrial disease with symptoms such as epilepsy, involuntary muscle twitching and difficulty coordinating muscle movements, but the disease can affect many functions. When examined under a microscope, muscle tissue has characteristic changes.

MHRA. The UK Medicines and Healthcare products Regulatory Agency. MIDD. Maternally Inherited Diabetes and Deafness

Mitochondria. That part of each cell that provides effective energy production in the form of conversion of oxygen and nutrients in the body into chemical energy.

Mitochondrial medicine. Field of research and development of pharmaceuticals that protect the mitochondria.

Mitochondrial myopathy. Primary mitochondrial disease which affects the muscles.

NAD+/NADH. A coenzyme involved in metabolism. NAD+ and NADH have central roles in cell- and mitochondrial metabolism and energy production.

NAFLD. Non-Alcoholic Fatty Liver Disease.

NASH. Non-alcoholic steatohepatitis, inflammatory fatty liver disease. ODD. Orphan Drug Designation. Facilitates development and commercialization, and may, upon receiving marketing authorization, provide orphan drug status with seven or ten years of market exclusivity (in the US and Europe, respectively).

PEO/CPEO. Mitochondrial disease. Progressive External Ophthalmoplegia/Chronic Progressive External Ophthalmoplegia.

Pharmacokinetics. Describes how the body affects a specific drug after administration.

Phase (1,2 and 3). The various stages of trials on the efficacy of a pharmaceutical in humans. See also "clinical trial." Phase 1 examines the safety on healthy human subjects, Phase 2 examines efficacy in patients with the relevant disease and Phase 3 is a large-scale trial that verifies previously achieved results. In the development of new pharmaceuticals, different doses are trialed and safety is evaluated in patients with relevant disease, Phase 2 is often divided between Phase 2a and Phase 2b.

Preclinical. That stage of drug development that occurs before a candidate drug is trialed on humans.

Primary mitochondrial diseases. Metabolic diseases that affect the ability of cells to convert energy. An estimated 12 in every 100,000 people affected. Often present in early childhood and lead to severe symptoms, such as mental retardation, heart failure and rhythm disturbances, dementia, movement disorders, severe diabetes, stroke-like episodes, deafness, blindness, limited mobility of the eyes, vomiting and seizures.

Psychomotor regression. When the development of the ability to perform will-driven movements is initially normal but deteriorates during infancy or early childhood.

TBI. Traumatic Brain Injury. An injury to the brain where some nerve cells are subjected to immediate damage. The injury then continues to exacerbate several days after the incident, which significantly impacts the final extent of damage.

About Abliva

Abliva develops medicines for the treatment of primary mitochondrial diseases. These rare and often very severe diseases occur when the cell's energy provider, the mitochondria, do not function properly. The company is focused on two projects. KL1333, a powerful NAD+ regulator, is in clinical development and has been granted orphan drug designation in Europe and the US. NV354, an energy replacement (succinate) therapy, will enter the clinic in 2022. Abliva is based in Lund, Sweden.

What is primary mitochondrial disease?

Primary mitochondrial disorders are metabolic diseases that affect the cells' ability to convert energy. The diseases can manifest very differently depending on the organs affected. They have historically been viewed as clinical syndromes and more recently as disease spectra, caused by genetic defects affecting mitochondrial function. It is estimated that 125 persons per million have a primary mitochondrial disease.

Abliva's discovery projects focus on deeper understanding of the mechanisms for our unique chemistry platforms, and the development of next-generation compounds for primary mitochondrial diseases.

Stock exchange

Abliva is listed on Nasdaq Stockholm, Sweden (ticker: ABLI).

Abliva AB (publ)

Medicon Village, SE-223 81 Lund Phone: +46 46 275 62 20 (switchboard) ir@abliva.com www.abliva.com