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Abliva — Interim / Quarterly Report 2024
May 23, 2024
3131_10-q_2024-05-23_8499b3a1-ab3f-4d22-99a2-652e6d42c234.pdf
Interim / Quarterly Report
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Report Interim
January - March 2024

Delivering mitochondrial health
First Quarter Summary
SEK 46 million raised through preferential rights issue Preparations for the interim analysis ongoing
Important events January - March 2024
- The Board of Directors of Abliva AB on 22 February resolved on a capital raise totalling app. SEK 88 million through a fully guaranteed rights issue of app. SEK 46 million, and a directed issue of convertible bonds of app. SEK 42 million. The convertible loan amount shall be paid and immediately converted into shares in the Company after the announcement of the interim data from the KL 1333 Phase 2 study provided the results from the study is positive, i.e. non futile.
- Abliva held an Extraordinary General Meeting on March 26, 2024, where the capital raise was approved.
Important events after the reporting period
• The new share issue with preferential rights for existing shareholders, announced on 22 February 2024 and carried out in April 2024, was subscribed to 100 percent, which means that Abliva raises approximately SEK 46 million before deduction for transactions costs.
Financial information
January-March 2024*
- Net revenues: SEK 0 (0)
- Other operating income: SEK 838,000 (1,055,000)
- Loss before tax: SEK 18,183,000 (16,092,000)
- Loss per share before dilution: SEK 0.02 (0.02)
- Diluted loss per share: SEK 0.02 (0.02)
- * APM Alternative performance measures, see definition on page 19.
Countdown to Interim Analysis
The first quarter of 2024 had the team working across three axes, progressing FALCON towards interim analysis, financing, and increasing Abliva's visibility. Financing secured we are now looking forward to the interim analysis, ensuring everything is in place for the mid-year readout.
FALCON Interim Analysis is On Track
With Wave 1 fully enrolled in December, the team continues to work closely with the FALCON clinical sites, ensuring that operational questions are answered, and data collection is timely and accurate. The team is working to 'clean' the data (or confirm the recorded data is correct and entered in the systems in the appropriate manner) to enable a short timeline to interim analysis. The interim analysis will include the data for the first 24 weeks of dosing (KL1333 or placebo) for the Wave 1 patients. Once the last patient has had their 24-week visit, the final data will be cleaned and sent to the Independent Data Monitoring Committee (DMC) for their review. In their analysis the DMC will review the safety profile of KL1333 and the potential to achieve statistical significance after 48 weeks of dosing. After reviewing the data, the DMC will make a recommendation as to whether the study should continue, and, if so, the final size of the study. If the recommendation is to stop the study, we will review the broader set of clinical data and return with a recommendation for the program based on that secondary analysis.
Keeping Connected With the Mitochondrial Disease Community
The quarter started with an opportunity to meet with French physicians and FALCON investigators during a national mitochondrial disease meeting in Strasbourg, France in early February. In March the Abliva team traveled to Hinxton, UK, for the Mitochondrial Medicine – Therapeutic Development meeting where we had the chance to learn about recent advances in mitochondrial research and connect with some of our fellow drug developers. We are now looking forward to the Mitochondrial Medicine Conference, sponsored by
the United Mitochondrial Disease Foundation (UMDF), a prominent patient advocacy foundation in the US. Being the premier annual meeting in our space, this event brings together physicians, researchers, patients, and companies focused on developing therapies for mitochondrial disease. We are looking forward to meeting with the other companies developing medicines, connecting with the physicians participating in Wave 1 and Wave 2 of our study, and talking with patients about their experiences living with mitochondrial disease.

"In their analysis the DMC will review the safety profile of KL1333 and the potential to achieve statistical significance after 48 weeks of dosing"
Investor Outreach Increases As We Approach Interim Analysis
This week we were honored to host a virtual KOL event for investors, shareholders, and potential partners, featuring Amel Karaa MD, a mitochondrial disease expert, internist and clinical geneticist who treats patients at Massachusetts General Hospital in Boston. During the event, Amel educated the group on primary mitochondrial disease, the patient condition and the challenges and opportunities for developing medicines for these patients. Our CMO, Magnus Hansson, then introduced the group to KL1333 – the mechanism of action, data to date and the ongoing clinical study. The event ended with a stimulating question and answer session. Attendance at the event was fantastic, and I'd like
to thank everyone who joined us for your engagement and continued interest in the program.
We have also been meeting investors and continue to hear positive feedback on the program. We started the season at the Kempen Life Science event in April, and then Magnus and I attended BioEquity in mid-May. Coming up, Magnus will be speaking at the BioStock Global Forum on May 30 at 13:45 CET in Lund, and I will be attending BioInternational in San Diego in early June.
Successful Financing Round Announced
In February, we announced a two-part financing round comprised of a preferential rights issue (with a subscription period in April) and a convertible loan that would convert with a positive (i.e. non-futile) readout of the interim analysis. The company announced a successful completion of the issue in mid-April, raising SEK 46 million in the rights issue for the company (before transaction costs). Later in the month we announced that several of the guarantors had elected to take their underwriting fee in shares, a strong signal of their commitment and belief in the company.
As you may have heard at our KOL event this week, living with a chronic disease is difficult for everyone, and those that lack a supportive network of friends and family often deal with the suffering alone. In rare diseases this is even more often the case, as many rare disease patients have never met someone else with the disease. Imagine being diagnosed with primary mitochondrial disease and then being told that there is nothing you can do. We bring hope. Here's to a successful interim analysis this summer that takes us one step forward to a treatment for these patients.
Best wishes,
Ellen Donnelly CEO
Innovative Portfolio in Rare and Severe Mitochondrial Disease

Primary mitochondrial disease affects the ability of cells to convert energy. It can manifest itself very differently depending on the organs impacted and the number of dysfunctional mitochondria in that organ. Historically viewed as clinical syndromes, our knowledge about the various mutations underlying mitochondrial disease has increased, improving our ability to identify and treat these patients. It is estimated that 125 people per million have primary mitochondrial disease.
Primary mitochondrial disease often presents 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 epileptic seizures.
| PROGRAM | DISEASE | DISCOVERY | PRECLINICAL | PHASE 1 | PHASE 2*** | MARKET |
|---|---|---|---|---|---|---|
| KL1333* | Mitochondrial disease (mtDNA**) |
|||||
| NV354* | Mitochondrial disease (Neurology) |
|||||
| Early programs |
Mitochondrial disease |
*KL1333 and NV354 have Orphan Drug Designation (ODD) in the U.S. and Europe, and KL1333 has Fast Track designation in the U.S. **mtDNA-related mitochondrial disorders caused by mutation(s) in mitochondrial DNA (as opposed to nuclear DNA). ***Given that mitochondrial disease is an orphan disease, a Phase 2 study in these patients, if successful, can have the potential for market approval.
Strategic focus: Mitochondrial Disease
At Abliva, we are focused on becoming the leading company in mitochondrial medicine, developing therapeutics for mitochondrial disease, orphan indications of high unmet medical need. We intend to 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 company focused on the discovery of therapeutics for mitochondrial disease. We will do this with our clear strategy, strong portfolio of assets, research and development organization, and team with decades of experience in mitochondrial medicine and drug development.
Over the next few years, we will focus on the delivery of our portfolio to the market. We aim to:
- Augment our strong research and development capabilities and build a commercial organization.
- Bring new innovative therapeutics to the patients and fuel our pipeline with new candidates from discovery.
- Attract and retain talented colleagues with a passion for drug development.
- 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.
- Generate future revenues through two paths: sales revenue for the drugs we intend to bring to market, and revenue from out-licensing assets (through milestone payments and royalties).
Addressing Primary Mitochondrial Disease
Primary mitochondrial disease is a rare orphan disease where the energy metabolism in the cells, by the powerhouses of our cells – the mitochondria – is impaired. This causes deterioration that leads to multifaceted disorders and great suffering for patients. Mitochondrial medicine has become an area of ever-increasing focus for the pharmaceutical industry as there are currently no effective treatment options. Through Abliva's research and development, we have an opportunity to improve the health and quality of life of 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 different types of mitochondrial disease.
KL1333 is being developed as a treatment for primary mitochondrial disease patients suffering from multiple debilitating symptoms, including chronic fatigue and myopathy. KL1333 has completed several key Phase 1 studies that enabled the start of a potentially registrational Phase 2 study in 2022. KL1333 is protected by a composition of matter patent and Orphan Drug Designation (ODD) in the US and in Europe. It has also received Fast Track Designation in the US. The commercial opportunity is significant with even conservative estimates exceeding USD 1 billion per year in annual sales1).
NV354 is being developed for mitochondrial disease with neurologic complications, including Leigh syndrome, MELAS (Mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes), and LHON (Leber's hereditary optic neuropathy). NV354 has completed preclinical development and is supported by a strong group of patents as well as ODD in the US and Europe.
Further, Abliva has efforts ongoing to identify additional portfolio opportunities focused on the regulation and stabilization of cellular energy production.
Leveraging Opportunities in Rare Diseases
Abliva is committed to taking advantage of rare disease opportunities, successfully attaining ODD for both KL1333 and NV354. ODD provides significant benefits, including
regulatory assistance, cost reduction, advantageous pricing, and an additional layer of market exclusivity (10 years in the EU, 7 in the US). The outlook for reaching the market is also better than for traditional medicines2,3). KL1333 has also secured Fast Track designation in the US, streamlining development and marketing application reviews.
Seeking scientific advice from regulators in the US, UK, and Europe has been invaluable, resulting in a shift toward a single, potentially registrational, Phase 2 study for KL1333, expediting its path to market.
Building a World Class Organization
The key to the success of any company is the people who work there, and we are committed to attracting and retaining bright and 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). We appreciate the continued commitment of our shareholders and look to attract new investors as we advance our portfolio and build the company. The investment of Hadean Ventures in 2020 was the first step to bringing specialist investors into the company, and, since that time, they have been joined by life science specialist IP Group plc and Norwegian institutional investor Oslo Pensjonsforsikring AS. We continue to attract new specialist and institutional investors as we grow the company and commercialize our portfolio.
1) Gorman et al., Prevalence of Nuclear and Mitochondrial DNA Mutations Related to Adult Mitochondrial Disease, 2015.
2) Jayasundra et al. Orphanet J of Rare Dis. Estimating the clinical cost of drug development for orphan versus non-orphan drugs. 2019.3) EvaluatePharma, Orphan Drug Report 2019.
KL1333 Innovative therapy in late-stage development
Patient recruitment to Wave 1 of the FALCON study completed Interim analysis planned for mid-2024

*KL1333 has Orphan Drug Designation (ODD) in the U.S. and Europe and Fast Track designation in the U.S. **mtDNA-related mitochondrial disorders caused by mutation(s) in mitochondrial DNA (as opposed to nuclear DNA). ***Given that mitochondrial disease is an orphan disease, a Phase 2 study in these patients, if successful, can have the potential for market approval.
Events during the first quarter
• Dosing is ongoing at all Wave 1 sites in the FALCON study. The interim analysis remains on track for mid-2024.
Objectives for 2024
- Interim readout of the KL1333 FALCON study.
- Commencement of Wave 2 of the KL1333 FALCON study.
- Progression of commercial production of KL1333.
DISEASE AREA
Abliva's lead candidate, KL1333, has been designed to treat chronic fatigue and myopathy (muscle weakness) in genetically confirmed adult patients with primary mitochondrial disease. 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.
KL1333 has the ability to restore the ratio of NAD+ and NADH, and thus leads to the formation of new mitochondria and improved energy levels.
THE FALCON STUDY
The FALCON study is a global, randomized, placebo-controlled, potentially registrational, Phase 2 study testing KL1333 in adult patients with primary mitochondrial disease with mitochondrial DNA mutations who experience chronic fatigue and myopathy.
Efficacy will be evaluated with two alternate primary endpoints, a mitochondrial disease-specific fatigue scale and a functional test of myopathy, the 30 second Sit-to-Stand test. The study is designed so that the result at study completion has the potential to be positive both if only one or both of the primary endpoints show clinical benefit. All patients will take KL1333 or placebo twice daily for 48 weeks. The study has an adaptive design and will be run in two waves with 120 – 180 total patients participating.

PATH TO MARKET
KL1333 has received Orphan Drug Designation in both the US and EU and Fast Track Designation in the US. Upon approval, the drug is expected to see significant uptake with an estimated patient population of up to 1:5,000 people1 . Considering typical orphan drug pricing, this translates into a blockbuster opportunity of over USD 1 billion in peak sales.
1) Gorman et al.,Prevalence of Nuclear and Mitochondrial DNA Mutations Related to Adult Mitochondrial Disease, 2015
NV354 First-in-class therapeutic targeting high unmet need
Orphan drug designation in both the U.S. and Europe

*NV354 has Orphan Drug Designation (ODD) in the U.S. and Europe.
**Given that mitochondrial disease is an orphan disease, a Phase 2 study in these patients, if successful, can have the potential for market approval.
• Given the prioritization of KL1333, no significant cost-intensive operational activities are planned for NV354 at this time.
INITIAL FINDINGS
The drug candidate was discovered due to its ability to increase mitochondrial function in cells from mitochondrial Leigh syndrome patients. Leigh syndrome usually debuts at one to two years of age and includes psychomotor regression, low muscle tone, and developmental delays. The disease is fatal, and children with early-onset Leigh syndrome usually die
TREATMENT OBJECTIVE
NV354 is being developed for mitochondrial disease with neu-rologic complications, in particular at insufficient activity in the mitochondrial protein complex I. The resulting deficiency in energy conversion contributes to clinical signs and symptoms in many types of mitochondrial disease, including neurologic complications seen in Leigh syndrome, MELAS, and LHON. There are also expansion opportunities outside of mitochondrial disease, including neurologic conditions where mitochondrial dysfunction has been confirmed.
HIGH UNMET MEDICAL NEED
before adulthood. Given the orphan drug designation and the high unmet medical need, NV354 is expected to have an expedited path to market and the potential for significant commercial sales.

In Leigh syndrome and related mitochondrial diseases, the first step in energy production (complex 1) does not work properly. NV354, a succinate prodrug, bypasses this deficiency and restores the energy to the cell.
Consolidated Statement of
Comprehensive Income
Revenues
The consolidated turnover during the first quarter of 2024 was SEK 0 (0). Other operating revenues for the first quarter were SEK 838,000 (1,055,000) and pertain to net exchange rate gains.
Results of operations
The operating loss for the first quarter was SEK 18,170,000 (16,216,000). The net loss before tax for the first quarter amounted to SEK 18,183,000 (16,092,000).
The operating loss was affected by other external expenses, which for the full were SEK 14,218,000 (11,840,000). During the first quarter, expenses related to development projects, as a part of external expenses, have affected the result with SEK 11,598,000 (8,307,000) whereof SEK 11,589,000 (8 038,000) relates to project in clinical phase. The cost for Projects in the clinical phase are higher, compared to the same period last year, due to predetermined payment schedules to suppliers. Personnel expenses during the first quarter amount to SEK 4,305,000 (4,720,000) and are less compared to last year due to less employees .
Profit/loss from financial items
Financial items for the first quarter amount to SEK -13,000 (123,000) and refers mainly to accrued interests.
| 1 Jan, 2024 | 1 Jan, 2023 | 1 Jan, 2023 | |
|---|---|---|---|
| (SEK 000) Note |
31 Mar, 2024 | 31 Mar, 2023 | 31 Dec, 2023 |
| Net sales | - | - | 137 |
| Other operating income | 838 | 1,055 | 1,345 |
| 838 | 1,055 | 1,482 | |
| Operating expenses | |||
| Other external expenses | -14,218 | -11,840 | -68,819 |
| Personnel cost | -4,305 | -4,720 | -18,785 |
| Depreciation and write-down of tangible and intangible assets | -485 | -711 | -10,426 |
| Other operating expenses | - | - | - |
| -19,008 | -17,271 | -98,030 | |
| Operating income | -18,170 | -16,216 | -96,548 |
| Profit/loss from financial items | |||
| Result from other securities and receivables related to non current assets | - | - | 34 |
| Financial income | 1 | 143 | 1,072 |
| Financial costs | -14 | -20 | -76 |
| -13 | 123 | 1,030 | |
| Profit/loss before tax | -18,183 | -16,092 | -95,518 |
| Income tax 2 |
1 | - | 9 |
| Profit/loss for the period | -18,182 | -16,092 | -95,509 |
| Other comprehensive income | |||
| Items that may be reclassified to profit or loss | |||
| Translation differences on foreign subsidiaries | 52 | -6 | -30 |
| Total comprehensive income for the period | -18,130 | -16,098 | -95,539 |
| Loss for the period attributable to: | |||
| Parent company shareholders | -18,182 | -16,092 | -95,509 |
| Non-controlling interests | - | - | - |
| -18,182 | -16,092 | -95,509 | |
| Total comprehensive income for the period | |||
| Parent company shareholders | -18,130 | -16,098 | -95,539 |
| Non-controlling interests | - | - | - |
| -18,130 | -16,098 | -95,539 | |
| Earnings per share before and after dilution(SEK) based on average number of shares | -0.02 | -0.02 | -0.09 |
| Average number of shares before and after dilution | 1,056,299,165 1,056,299,165 1,056,299,165 |
Consolidated Statement of
Financial Position
Financial position
The equity/assets ratio was 84 (95) percent as of 31 March 2024, and equity was SEK 52,871,000 (70,718,000) compared to beginning of the year. Long term liabilities SEK 321,000 (711,000) refers to long term part of the rigth of use asset leases. Current liabilities amounted to SEK 9,978,000 (6,932,000) as of March 31, 2024, and mainly refers to activities realted to the FALCON study. Other short-term recivables amounts to 0 (59,466) and refered to the investment of surplus liquidity.Cash and cash equivalents amounted to SEK 31,156,000 ( 59,518,000) as of 31 March 2024, a decrease of SEK 26,508,000 from the beginning of the year. Total assets as of 31 March 2024 were SEK 63,170,000 (156,650,000).
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 about 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 |
31 Mar, 2024 31 Mar, 2023 31 Dec, 2023 | ||
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | 1 | ||
| Patents | 10,477 | 18,468 | 10,505 |
| Other Intangible assets | 907 | 1,042 | 941 |
| 11,384 | 19,510 | 11,446 | |
| Tangible assets | |||
| Equipment | 13 | 42 | 20 |
| Right of use asset leases | 666 | 1,046 | 761 |
| 679 | 1,088 | 781 | |
| Financial assets | |||
| Other long-term securities | 13,101 | 13,101 | 13,101 |
| 13,110 | 13,101 | 13,110 | |
| Total non-current assets | 25,173 | 33,700 | 25,337 |
| Current assets | |||
| Other receivables | 789 | 1,265 | 1,051 |
| Prepaid expenses and accrued income | 6,052 | 2,701 | 3,447 |
| Other short term recivables | - | 59,466 | - |
| Cash and cash equivalents | 31,156 | 59,518 | 57,664 |
| 37,997 | 122,950 | 62,162 | |
| TOTAL ASSETS | 63,170 | 156,650 | 87,499 |
Financial Position
| (SEK 000) | Note | 31 Mar, 2024 31 Mar, 2023 31 Dec, 2023 | |||
|---|---|---|---|---|---|
| EQUITY AND LIABILITIES | |||||
| Equity attributable to the shareholders of the parent company | |||||
| Share capital | 52,815 | 52,815 | 52,815 | ||
| Consolidated Statement of Financial Additional paid in capital Translation reserve Retained earnings* Total equity attributable to the shareholders of the parent Total equity Long-term liabilities Other longtrem liabilities Short-term liabilities Accounts payable Other liabilities Accrued expenses and deferred income Total liabilities TOTAL EQUITY AND LIABILITIES |
905,972 | 905,823 | 905,972 | ||
| 855 | 827 | 803 | |||
| -906,772 | -810,458 | -888,872 | |||
| 52,871 | 149,007 | 70,718 | |||
| 52,871 | 149,007 | 70,718 | |||
| 321 | 711 | 424 | |||
| 321 | 711 | 424 | |||
| Position | 4,996 | 2,922 | 9,348 | ||
| 1,187 | 674 | 699 | |||
| 3,795 | 3,337 | 6,310 | |||
| 9,978 | 6,932 | 16,357 | |||
| 10,299 | 8,354 | 17,205 | |||
| 63,170 | 156,650 | 87,499 |
Consolidated Statement of
Changes in Equity
| 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 2023 | 52,815 | 905,221 | 833 | -794,581 | 164,287 | 0 | 164,287 |
| Comprehensive profit/loss for the period | - | - | - | - | - | - | - |
| Profit/loss for the period | - | - | - | -95,509 | -95,509 | - | -95,509 |
| Other comprehensive income | - | - | - | - | - | - | - |
| Translation differences | - | - | -30 | - | -30 | - | -30 |
| Other comprehensive profit/loss for the period, net after tax | - | - | -30 | - | -30 | - | -30 |
| Total comprehensive profit/loss | - | - | -30 | -95,509 | -95,539 | - | -95,539 |
| Transactions with shareholders | - | - | - | - | - | - | - |
| Rights Issue | - | - | - | - | - | - | - |
| Share-based payment | - | - | - | 1,218 | 1,218 | - | 1,218 |
| Change of ownership in share issue | - | 752 | - | - | 752 | - | 752 |
| Total transactions with shareholders | - | 752 | - | 1,218 | 1,970 | - | 1,970 |
| Closing balance, 31 December 2023 | 52,815 | 905,972 | 803 | -888,872 | 70,718 | 0 | 70,718 |
| Opening balance, 1 January 2023 | 52,815 | 905,221 | 833 | -794,582 | 164,287 | 0 | 164,287 |
| Comprehensive profit/loss for the period | |||||||
| Profit/loss for the period | - | - | - | -16,092 | -16,092 | - | -16,092 |
| Other comprehensive income | |||||||
| Translation differences | - | - | -6 | - | -6 | - | -6 |
| Other comprehensive profit/loss for the period, net after tax | - | - | -6 | - | -6 | - | -6 |
| Total comprehensive profit/loss | - | - | -6 | -16,092 | -16,098 | - | -16,098 |
| Transactions with shareholders | |||||||
| Rights Issue* | - | - | - | - | - | - | - |
| Share-based payment | - | 602 | - | - | 602 | - | 602 |
| Shareholder contribution | - | - | - | 217 | 217 | - | 217 |
| Total transactions with shareholders | - | 602 | - | 217 | 819 | - | 819 |
| Closing balance, 31 March 2023 | 52,815 | 905,823 | 827 | -810,457 | 149,008 | 0 | 149,008 |
| Opening balance, 1 January 2024 | 52,815 | 905,972 | 803 | -888,872 | 70,718 | 0 | 70,718 |
| Comprehensive profit/loss for the period | |||||||
| Profit/loss for the period | - | - | - | -18,182 | -18,182 | - | -18,182 |
| Other comprehensive income | |||||||
| Translation differences | - | - | 52 | - | 52 | - | 52 |
| Other comprehensive profit/loss for the period, net after tax | - | - | 52 | - | 52 | - | 52 |
| Total comprehensive profit/loss | - | - | 52 | -18,182 | -18,130 | - | -18,130 |
| Transactions with shareholders | |||||||
| Share-based payment | - | - | - | - | - | - | - |
| Change of ownership in share issue | - | - | - | 283 | 283 | - | 283 |
| Total transactions with shareholders | - | - | - | 283 | 283 | - | 283 |
| Closing balance, 31 March 2024 | 52,815 | 905,972 | 855 | -906,771 | 52,871 | 0 | 52,871 |
Consolidated Statement of Cash Flows
Cash flow and investments
Operating cash flow for the first quarter was SEK -26,389,000 (-7,330,000). The cash flow effect related to investments in intangibles equals SEK -82,000 (-65,000) for the first quarter. Cash flow for the first quarter equals SEK -26,563,000 (-6,875,000).
| (SEK 000) | 1 Jan, 2024 | 1 Jan, 2023 | 1 Jan, 2023 |
|---|---|---|---|
| 31 Mar, 2024 31 Mar, 2023 31 Dec, 2023 | |||
| Cash flow from operating activities | |||
| Operating income | -18,170 | -16,216 | -96,547 |
| Adjustments for non-cash items: | |||
| Depreciation | 485 | 711 | 10,426 |
| Currency differences on intercompany items | 84 | -4 | -58 |
| Impaired Value | -8 | -11 | -7 |
| Share-based payments | 283 | 217 | 1,218 |
| Result from other securities and receivables related to non current assets | - | - | 34 |
| Interest received | 1 | 143 | 1,072 |
| Interest paid | -14 | -20 | -76 |
| Paid taxes | - | - | - |
| Net cash from operating activities before changes in working capital | -17,339 | -15,179 | -83,938 |
| Changes in working capital | |||
| Increase/decrease of other current assets | -2,341 | 19,991 | 78,923 |
| Increase/decrease of other short-term liabilities | -6,709 | -12,142 | -2,787 |
| Changes in working capital | -9,050 | 7,849 | 76,136 |
| Cash flow from operating activities | -26,389 | -7,330 | -7,802 |
| Investing activities | |||
| Acquisition of intangible assets | -82 | -65 | -1,290 |
| Acquisition of tangible assets | - | - | - |
| Cash flow from investing activities | -82 | -65 | -1,290 |
| Financing activities | |||
| New share issue | - | 602 | 752 |
| Amoritization lease | -92 | -82 | -338 |
| Increase/decrease of long-term liabilities | - | - | - |
| Cash flow from financing activities | -92 | 520 | 414 |
| Cash flow for the period | -26,563 | -6,875 | -8,678 |
| Cash and cash equivalents at the beginning of the period | 57,664 | 66,392 | 66,392 |
| Effect of exchange rate changes on cash | 55 | 1 | -50 |
| Cash and cash equivalents at end of period | 31,156 | 59,518 | 57,664 |
Parent Company Income Statement
Parental company
Company earnings after tax for the first quarter amounts to SEK -17,856,000 (-15,628,000). Accordingly, no further specific information regarding the parent company is presented.
(SEK 000) 1 Jan, 2024 1 Jan, 2023 1 Jan, 2023 Note 31 Mar, 2024 31 Mar, 2023 31 Dec, 2023 Net sales - - 137 Other operating income 862 1,045 1,508 862 1,045 1,645 Operating expenses Other external expenses -15,740 -13,091 -75,410 Personnel cost -2,590 -3,109 -11,803 Depreciation and write-down of tangible and intangible assets -389 -616 -10,046 Other operating expenses - - - -18,719 -16,816 -97,259 Operating income -17,857 -15,772 -95,614 Profit/loss from financial items Result from other securities and receivables related to non current assets - - -23,691 Interest income and other similar profit items 1 143 1,072 Interest expenses and other similar loss items - - -5 1 143 -22,624 Profit/loss before tax -17,856 -15,628 -118,238 Income tax 2 - - - Profit/loss for the period -17,856 -15,628 -118,238
Parent Company
Statement of Comprehensive Income
| (SEK 000) | 1 Jan, 2024 | 1 Jan, 2023 | 1 Jan, 2023 |
|---|---|---|---|
| Note 31 Mar, 2024 31 Mar, 2023 31 Dec, 2023 | |||
| Profit/loss for the period | -17,856 | -15,628 | -118,238 |
| Other comprehensive income | - | - | - |
| Total comprehensive profit/loss for the period | -17,856 | -15,628 | -118,238 |
Parent Company Balance Sheet
| (SEK 000) Note |
31 Mar, 2024 31 Mar, 2023 31 Dec, 2023 | ||
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Intangible assets 1 |
|||
| Patents | 10,477 | 18,469 | 10,505 |
| Other intangible assets | 907 | 1,042 | 941 |
| 11,384 | 19,511 | 11,446 | |
| Tangible assets | |||
| Equipment | 13 | 42 | 20 |
| 13 | 42 | 20 | |
| Financial assets | |||
| Shares in subsidiaries 3 |
1,465 | 24,557 | 1,465 |
| Other long-term placement | 13,100 | 13,101 | 13,101 |
| 14,565 | 37,658 | 14,566 | |
| Total non-current assets | 25,962 | 57,211 | 26,032 |
| Current assets | |||
| Short term receivables | |||
| Receivables from group companies | - | 602 | - |
| Other receivables | 1,301 | 1,241 | 1,031 |
| Prepaid expenses and accrued income | 6,052 | 2,646 | 3,425 |
| 7,353 | 4,488 | 4,456 | |
| Other short term recievables | - | 59,466 | - |
| Cash and bank balances | 30,186 | 58,614 | 55,826 |
| Total current assets | 37,539 | 122,568 | 60,282 |
| TOTAL ASSETS | 63,501 | 179,779 | 86,314 |
Parent Company Balance Sheet EQUITY AND LIABILITIES
| (SEK 000) Note |
31 Mar, 2024 31 Mar, 2023 31 Dec, 2023 | ||
|---|---|---|---|
| Equity | |||
| Restricted equity | |||
| Share capital | 52,815 | 52,815 | 52,815 |
| Statutory reserve | 1,856 | 1,856 | 1,856 |
| Development expenditure reserve** | - | 788 | - |
| 54,671 | 55,459 | 54,671 | |
| Unrestricted equity | |||
| Share premium reserve | 175,488 | 175,263 | 225 |
| Retained earnings | -159,343 | -41,892 | 134,159 |
| Profit/loss for the period | -17,856 | -15,628 | -118,238 |
| -1,711 | 117,742 | 16,145 | |
| Total equity | 52,960 | 173,201 | 70,816 - |
| Short-term liabilities | |||
| Accounts payable | 4,898 | 2,891 | 9,345 |
| Liabilities subsidiary | 1,620 | 749 | 1,620 |
| Other liabilities | 796 | 326 | 319 |
| Accrued expenses and deferred income | 3,227 | 2,612 | 4,213 |
| 10,541 | 6,578 | 15,498 | |
| TOTAL EQUITY AND LIABILITIES | 63,501 | 179,779 | 86,314 |
Notes Note 1 — Intangible assets
| (SEK 000) | Patents | Other | Total |
|---|---|---|---|
| ACCUMULATED COST | |||
| Opening balance 1 Jan. 2024 | 21,612 | 2,864 | 24,476 |
| Additions | 320 | - | 320 |
| Impaired value | -5 | - | -5 |
| Closing balance 31 Mar. 2024 | 21,927 | 2,864 | 24,791 |
| ACCUMULATED DEPRECIATION | |||
| Opening balance 1 Jan. 2024 | -11,107 | -1,923 | -13,030 |
| Depreciation for the period | -60 | -318 | -378 |
| Impaired value | -283 | 284 | 1 |
| Closing balance 31 Mar. 2024 | -11,450 | -1,957 | -13,407 |
| Residual value 31 Mar. 2024 | 10,477 | 907 | 11,384 |
| (SEK 000) | Patents | Other | Total |
|---|---|---|---|
| ACCUMULATED COST | |||
| Opening balance 1 Jan. 2023 | 36,086 | 2,864 | 38,950 |
| Additions | 1,459 | - | 1,459 |
| Impaired value | -15,933 | - | -15,933 |
| Closing balance 31 Dec. 2023 | 21,612 | 2,864 | 24,476 |
| ACCUMULATED DEPRECIATION |
| Opening balance 1 Jan. 2023 | -17,158 | -1,789 | -18,947 |
|---|---|---|---|
| Depreciation for the period | -1,290 | -134 | -1,424 |
| Impaired value | 7,341 | - | 7,341 |
| Closing balance 31 Dec. 2023 | -11,107 | -1,923 | -13,030 |
| Residual value 31 Dec. 2023 | 10,505 | 941 | 11,446 |
Note 2 – Tax
The group's total loss carry-forwards amounts to SEK 964,457,000 as of 31 March 2024 (825,819,000). The parent company's total loss carry-forwards amounts to SEK 938,246,000 as of 31 March 2024 (799,190,000). Because the company is loss making, management cannot judge when deductible loss carry-forwards will be utilized.
Note 3 – Shares and participations in group companies
Shares and participations in group companies relates to the holly owned american subsidiary Abliva Inc., Boston and the Swedish subsidiary Abliva Incentive AB, holding option program for the CEO and warrant program for managment and key personnel.
Other disclosures
Licensing and collaboration agreement with Owl Therapeutics
In November 2023, Abliva and Owl Therapeutics of San Antonio, Texas, entered into a licensing and collaboration agreement for the drug candidate NeuroSTAT®.
Transactions with related parties
Transactions between the company and its subsidiaries, which are related parties to the company, have been eliminated on consolidation, and accordingly, no disclosures are made regarding these transactions.
Apart from remuneration to senior executives 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 March 2024 was 6 (8), of which 4 (6) are women.
Important events during the first quarter (Jan-Mar 2024)
For further information, see page 2.
Important events after the reporting period
For further information, see page 2.
Incentive programs/share warrants
The Company has two option programs and two warrant programs
The annual general meeting on 20 May, 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 share in Abliva AB up to a maximum of 4,600,000 ordinary shares. The redemption price amounts to SEK 0.725. The program is vested at 25% per year on 1 June, 2022, 1 June, 2023, 1 June, 2024 and 1 June, 2025. Latest redemption date is 31 December, 2025. The Board has decided to termintate the program.
The general meeting on 8 March, 2023, decided on a second four-year incentive stock option program 2023/2027 for the Company's CEO. The incentive stock option program entitles the holder to a new share in Abliva AB up to a maximum of 17,500,000 ordinary shares. The redemption price amounts to SEK 0.27. The program is vested at 25% per year on 1 April, 2024, 1 April, 2025, 1 April, 2026 and 1 April, 2027. Latest redemption date is 31 December, 2027.
Warrant Program
At the general meeting on 8 March, 2023, it was decided on a warrant program 2023/2027 to management and other key employees of a maximum of 23.5 million warrants at a price of SEK 0.06 per warrant, corresponding to a subscription price of SEK 0.67 per share. In total, approx. 10 million options have been subscribed in the warrant program for management and other key employees. Redemption date is 1 June - 31 December 2027.
On 5 May, 2023, the AGM resolved on a warrant program 2023/2027 for certain board members of a maximum of 4.5 million warrants at a price of SEK 0.05 per warrant and a subscription price of SEK 0.5767 per share. One warrant entitles the holder to one new share in Abliva AB Redemption date is June 1 - December 31, 2027.
In case of full utilization of all incentive programs, excluding Employee option program 2021/2025 which is being wound up, the maximum dilution amounts to 2.24 per cent on a fully diluted basis. The dilution effects have been calculated as the number of additional shares and votes in relation to the number of existing shares and votes plus the number of additional shares and votes. The dilution is only expected to have a marginal effect on the Company's key performance indicator "Earnings (loss) per share".
For further information please see www.abliva.com and the Annula report 2023 note 11.
Audit review
This Interim Report has not been subject to review by the company's auditors.
Upcoming financial statements
| Q2 Report January-June 2024 | August 22, 2024 |
|---|---|
| Q3 Report January-September 2024 | November 21, 2024 |
| Year-End Report 2024 | February 21, 2025 |
The interim reports and the Annual Year Report are available at www.abliva.com
Annual General Meeting 2024
Annual General Meeting of Abliva AB (publ) will be held at 1 p.m. on Thursday, May 23, 2024, at Medicon Village, Scheeletorget 1, in Lund, Sweden.
Proposed appropriation of profits
The Board of DIrectors proposes that Abliva does not pay dividends for the financial year 2023.
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. For a more detailed description of the risks and uncertainty factors that Abliva is facing, please refer to the risk analysis on pages 16-19 in the Annual Report for 2023.
Financing
The Board continuously monitors and evaluates the company's funding need and financial position given ongoing development. The company announced the outcome from a preferential rights issue in April 2024 of approximately SEK 39.5 million after transaction costs. The Board acknowledges that further funding (equity, loan, grants and/or partnerships) will be required to recruit patients into Wave 2 of the FALCON study. If the company is not successful in securing additional financing, there is a risk that Wave 2 of the program will be delayed. By adapting the pace of ongoing activities, with the present liquidity and funds from the preferential rights issue of approximately SEK 39.5 million after transaction costs, there is financing support for continuing the business for the next twelve-month period. The interim report is thus prepared on the basis of a going concern assumption.
Disputes
Abliva is not involved in any disputes.
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 Reportin..
The 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 2023 on pages 43-55.
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, May 23, 2024
David Laskow-Pooley David Bejker Roger Franklin
Chair 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 8:30 a.m. CEST on May 23, 2024.
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.
Glossary
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)".
(The) FALCON study. Abliva's global potentially registrational Phase 2 clinical trial with the drug candidate KL1333. The study will evaluate the efficacy of KL1333 on fatigue and muscle weakness in adult patients with primary mitochondrial diseases caused by inherited mutations in the mitochondrial DNA.
Fatigue. Extreme tiredness. Often includes muscle fatigue with exercise intolerance.
FDA. The United States Federal Food and Drug Administration.
Indication. A disease condition requiring treatment, such as traumatic brain injury or fatty liver, NASH.
Hypotonia. An abnormally low level of tension, important for posture, in the resting muscle
Interim analysis. The analysis of data in a clinical trial comparing intervention groups before the formal completion of the trial, typically before patient recruitment is complete. Can be used for various purposes, such as assessing the statistical strength of the study to meet the predetermined endpoints.
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.
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.
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.
mtDNA. Mitochondrial DNA. Mitochondria's own genome that is inherited only on the maternal line. Separate from the cells' genome (nuclear DNA = nDNA) inherited by both parents.
NAD+/NADH. A coenzyme involved in metabolism. NAD+ and NADH have central roles in cell- and mitochondrial metabolism and energy production.
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.
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 disease. Metabolic disease that affects the ability of cells to convert energy. An estimated 12 in every 100,000 people are affected. Often presents in early childhood and leads 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.
Succinate. Endogenous substance that plays an important role in mitochondrial energy production. Succinate is used by mitochondrial protein complex II.
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 discovers and develops medicines for the treatment of mitochondrial disease. This rare and often very severe disease occurs when the cell's energy provider, the mitochondria, do not function properly. The company has prioritized two projects. KL1333, a powerful regulator of the essential co-enzymes NAD+ and NADH, has entered late-stage development. NV354, an energy replacement therapy, has completed preclinical development. Abliva is based in Lund, Sweden.
What is primary mitochondrial disease?
Primary mitochondrial disease affects the ability of cells to convert energy. It can manifest itself very differently depending on the organs impacted and the number of dysfunctional mitochondria in that organ. Historically viewed as clinical syndromes, our knowledge about the various mutations underlying mitochondrial disease has increased, improving our ability to identify and treat these patients. It is estimated that 125 people per million have primary mitochondrial disease.
Abliva's discovery projects focus on gaining a deeper understanding of the mechanisms underlying mitochondrial disease in order to enable us to design new molecules and develop the next-generation compounds targeting primary mitochondrial disease.
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) [email protected]