Egetis Therapeutics

Annual Report • Feb 22, 2023

Year-end report January-December 2022

Emcitate® project progressing with focus on applications for market approvals in the US and EU in 2023

Financial overview October-December

• Quarterly revenues MSEK 5,7 (3,2)
• Quarterly loss MSEK -77,8 (-32,1)
• Cash balances at the end of the quarter amounted to MSEK 127,7 (144,0)
• Cash flow for the period MSEK -62,8 (-29,6)
• Loss per share before/after dilution SEK -0.4 (-0.2)

Significant events during the period October-December

• Hosted a Capital Markets Day on October 13 in Stockholm, where an overview of the Company's strategy and project portfolio was presented (a video from the day can be found here)
• Continued to strengthen the commercial and medical affairs organizations for the expected launch of Emcitate in 2024
• Recruited Anny Bedard as President of Egetis North America

Emcitate

• Announced detailed design for small, randomized, placebo-controlled trial for Emcitate for US NDA submission
• Submitted an Expanded Access Program for Emcitate in the USA

Financial overview January-December

• Revenues for the period MSEK 22,6 (38,2)
• Loss for the period MSEK -193,8 (-104,5)
• Cash balances at the end of the period amounted to MSEK 127,7 (144,0)
• Cash flow for the period MSEK -19,5 (-145,0)
• Loss per share before/after dilution SEK -1.0 (-0.6)

Significant events after the reporting period

• Received MSEK 210 (gross) through an oversubscribed directed share issue
• Recruited Katayoun Welin-Berger as Vice President Operations, responsible for designing and managing the supply chains for development candidates and commercial products. Katayoun will join Egetis from Calliditas Therapeutics in March 2023

Financial overview

	2022	2021*	2022	2021*
	Oct-Dec	Oct-Dec	Jan-Dec	Jan-Dec
Net revenues, MSEK	5,7	3,2	22,6	38,2
Result after tax, MSEK	-77,8	-32,1	-193,8	-104,5
Cash flow, MSEK	-62,8	-29,6	-19,5	-145,0
Cash, MSEK	127,7	144,0	127,7	144,0
Equity ratio %	90%	93%	90%	93%
Earnings per share, SEK	-0.4	-0.2	-1.0	-0.6
Earnings per share after dilution, SEK	-0.4	-0.2	-1.0	-0.6
Average number of employees	15	11	15	11

*) The comparative figures in the table have been adjusted for the share issue in May 2022.

Comments from the CEO

I am very pleased with our progress during the last quarter of 2022, which enabled our directed share issue in the beginning of 2023. The Directed Issue was oversubscribed and Egetis received SEK 210 million before transaction costs. New investors comprise institutional international and Swedish sector specialist investors, including AXA Investment Managers, Handelsbanken Fonder AB through the investment fund Hälsovård Tema, and Medical Strategy GmbH, as well as existing investors including The Fourth Swedish National Pension Fund (AP4), Linc AB and Unionen. The net proceeds from the Directed Issue will primarily finance continued build-up of the Company's commercial infrastructure in Europe and the US and pre-launch activities for the planned commercialization of Emcitate in 2024, as well as general corporate purposes and financial flexibility.

Successful Capital Markets Day

On October 13, 2022, we hosted a Capital Markets Day in Stockholm, and presented an overview of the Company's strategy and project portfolio. The event was very successful, with positive feedback from analysts, investors and other stakeholders. In total, around 350 people either viewed it live or have streamed it afterwards. A recording is available on the Company's homepage and via this link.

The Emcitate project is progressing with focus on applications for market approvals in the US and EU in 2023

Egetis intends to submit a marketing authorization application for Emcitate to the EMA in the second quarter of 2023, based on existing clinical data, after sufficient stability data has been obtained for the commercial product of Emcitate.

As previously communicated, Egetis will conduct a confirmatory randomized placebo-controlled trial in 16 patients to verify the results of previous clinical trials and publications regarding thyroid hormone T3 levels. The first patient in the study is expected to be enrolled in the coming weeks. The delay from the anticipated start by end of 2022 is due to Covidrelated administrative backlog at the American hospital participating in the study. The design of the study, which is called ReTRIACt, is available on clinicaltrials.gov under the code NCT05579327.

Egetis intends to apply for market approval for Emcitate in the US in the second half of 2023, under the Fast Track Designation granted by the FDA.

The Triac Trial II study with Emcitate

The recruitment target for Triac Trial II was achieved in the second quarter of 2022 where 22 patients have been included. This study investigates the effect of treatment with Emcitate on neurocognitive endpoints in young boys (≤30 months) with MCT8 deficiency. Patients will initially be treated for 96 weeks with Emcitate, after which they will be followed for an additional two years. Results from the study are expected in mid-2024 and are planned to be submitted to regulatory authorities after market approvals have been obtained. The design of the Triac Trial II study is available on clinicaltrials.gov under the code NCT02396459.

Egetis has submitted an Expanded Access Program for Emcitate in the USA

There is continued large and increasing interest from physicians all over the world to treat patients suffering from MCT8-deficiency with Emcitate, which is already prescribed on an individual license to patients in over 25 countries. In total, over 170 patients are now being treated with Emcitate, and we see more and more patients gaining access to treatment. This underlines the great medical need for a treatment for these patients.

On the request of the FDA Egetis submitted in the fourth quarter of 2022 an 'Expanded Access Program' in the USA. By implementing our Expanded Access Program for Emcitate the administrative burden for treating physicians in the US will be reduced, should they wish to prescribe Emcitate to MCT8 patients under their care.

Egetis continues the step-wise build-up of an organization in the US and Europe for the commercialization of Emcitate in 2024

In December we announced that Anny Bedard has been recruited as President of Egetis in North America and as a member of the Company's leadership team. Anny has over 25 years of international experience in both established and entrepreneurial biopharmaceutical companies and 15 years of experience with rare diseases. Ms. Bedard will be responsible for establishing and maintaining a successful presence for Egetis and its products in the United States and Canada.

In November, we announced the recruitments of three General Managers (GMs) in Europe. Nigel Nicholls will take on the position as GM for the UK and Northern European Cluster (Ireland, Nordics and Baltics). He will join Egetis in April 2023 and be based in the UK. Raymond Francot has taken on the position as GM for Germany, Austria, Switzerland and Central and Eastern European Cluster. He joined Egetis in January 2023 and is based in Zurich, Switzerland. Sylvain Forget has taken on the position as GM for France and Southern European Cluster (Portugal, Spain, Italy and Greece). He joined Egetis in January 2023 and is based in Paris, France.

These key recruitments bring substantial experience and proven track records in successful launch preparations and commercialization of drugs in ultraorphan diseases, including products such as Spinraza®, Brineura® and Tecfidera®, as well as experience from several successful rare-disease companies, such as BioMarin, Global Blood Therapeutics, SOBI and Vertex.

Egetis continues to raise awareness of MCT8 deficiency among medical specialists and other key stakeholders

During the second half of 2022 Egetis participated with exhibition booths at seven international scientific and medical conferences. There is great interest among pediatric neurologists and pediatric endocrinologists to learn more about MCT8 deficiency, but general awareness of the disease is still limited. To increase awareness of the disease a new patient video has been created, which can be accessed here (www.mct8deficiency.com).

Developing a compelling clinical and economic value proposition

During the period, we have continued to assess the impact of MCT8 deficiency on patients and caregivers. To this end we have completed a so called Vignette study, involving treating physicians to derive utility values for a defined range of MCT8 deficiency health states, suitable for cost-effectiveness analysis. In addition, we have carried out a Caregiver study, to generate burden of disease data (costs and Quality of Life) from caregivers to support our value proposition and ensuring broad access.

The pivotal study Albatross for Aladote in the US, EU and UK

There is a significant medical need for the approximately 25% of patients who reach hospital more than eight hours after paracetamol overdose. These patients have an increased risk of acute liver failure and need additional treatment options beyond the currently available N-acetylcysteine (NAC). The design of the pivotal Phase Iib/III study, which is called Albatross, has been agreed with the FDA, EMA and MHRA. The start of the study is planned during 2023.

Cash position

We reported a cash position of approximately SEK 128 million as of December 31, 2022. Post period we raised net proceeds of SEK 196 million, after issuance costs, in a directed share issue.

Looking ahead

Egetis is an innovative and integrated pharmaceutical company, focused on projects in late clinical development phase for commercialization within the orphan drug segment for the treatment of serious and rare diseases with significant unmet medical needs. With the recently strengthened balance sheet we can now continue to be focused on developing our drug candidates Emcitate and Aladote for all the patients who have a great need for these therapies I look forward to informing you about the future development of Egetis during this upcoming transformative year for the Company.

Nicklas Westerholm, CEO

About Egetis Therapeutics

Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in latestage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.

The Company's lead drug candidate Emcitate is under development for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In previous studies (Triac Trial I and a longterm real-life study) Emcitate has shown highly significant and clinically relevant results on serum thyroid hormone T3 levels and secondary clinical endpoints. As a result of fruitful regulatory interaction Egetis intends to submit a marketing authorisation application (MAA) for Emcitate to the European Medicines Agency (EMA) during the second quarter of 2023 based on existing clinical data.

In the US, after discussions with the FDA, Egetis will conduct a small randomized, placebo-controlled study in 16 patients to verify the results on T3 levels seen in previous clinical trials and publications. Egetis intends to submit a new drug application (NDA) in the US for Emcitate in the second half of 2023 under the Fast-Track Designation granted by FDA.

Emcitate is currently being investigated in the Triac Trial II, a Phase II/III study in very young MCT8 deficiency patients (<30 months of age) exploring potential disease modifying effects of early

intervention from a neurocognitive and neurodevelopmental perspective. The recruitment target was achieved in the second quarter 2022 and 22 patients have been included in the study. Results are expected in mid 2024 and are expected to be submitted post-approval to regulatory authorities shortly thereafter.

Emcitate holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Emcitate has been granted Rare Pediatric Disease Designation (RPDD) which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval. This voucher can be transferred or sold to another sponsor.

The drug candidate Aladote is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed and the design of the upcoming pivotal Phase Iib/III study with the purpose of applying for market approval in the US and Europe for Aladote has been finalized after completed interactions with FDA, EMA and MHRA and study start is planned during 2023. Aladote has been granted ODD in the US and in the EU.

Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market. For more information, see www.egetis.com

Pipeline overview

Project updates

Emcitate

Events during the quarter

• Announced detailed design for small, randomized, placebo-controlled trial for Emcitate for US NDA submission
• Submitted an Expanded Access Program for Emcitate in the USA
• Egetis participated at the International Child Neurology Congress and Annual Meeting of the American Thyroid Association

Events after the reporting period

Egetis participated at the British Paediatric Neurology Association congress

About Emcitate

Emcitate is Egetis' lead drug candidate in clinical development. It addresses monocarboxylate transporter 8 (MCT8) deficiency, also known as Allan-Herndon-Dudley Syndrome (AHDS), a rare genetic disease that affects 1 in 70,000 men with high unmet medical need with no available treatment.

Thyroid hormones are crucial for the development and metabolic state of virtually all tissues. Thyroid hormone transport across the plasma membrane is required for the hormones' metabolism and intracellular action and is facilitated by thyroid hormone transporters, including MCT8. Mutations in the gene for MCT8 cause MCT8 deficiency. The gene is located on the X chromosome and therefore mainly affects men, as men only have one X chromosome.

The resulting dysfunction of MCT8 leads to impaired transport of thyroid hormone into certain cells and across the blood-brain-barrier and disruption of normal thyroid hormone regulation. Patients with MCT8 deficiency therefore have low concentrations of thyroid hormone in the central nervous system, which signals that the body should produce more thyroid hormone. This leads to increased levels of active thyroid hormone T3 in peripheral tissues, also called thyrotoxicosis. This leads to a complex pattern of symptoms with neurological developmental delay and intellectual disability, accompanied by severely elevated circulating thyroid hormone concentrations which are toxic for tissues including the heart, muscle, liver and kidney and results in symptoms such as failure to thrive, cardiovascular stress, insomnia and muscle wasting.

Most patients will never develop the ability to walk or even sit independently. At present there is no approved therapy available for the treatment of MCT8 deficiency.

Emcitate was granted Orphan Drug Designation in the EU in 2017 and the US in 2019. Emcitate received US Rare Paediatric Disease Designation (RPDD) in 2020. Upon approval of the NDA, sponsors holding a RPDD and meeting the criteria specified can apply to receive a Priority Review Voucher (PRV). A PRV provides accelerated FDA review of a subsequent new drug application for any drug candidate, in any indication, shortening time to market in the US. The voucher may also be sold or transferred to another sponsor. During the last few years PRVs have been sold for around \$100 million.

A Phase IIb clinical trial (Triac Trial I) in MCT8 deficiency has been completed which showed significant and clinically relevant treatment effects on key aspects of the disease. In October 2021, strong data from long-term treatment in patients with MCT8 deficiency up to 6 years, with Emcitate was published in the Journal of Clinical Endocrinology & Metabolism. The data comes from an investigator-initiated real-life cohort study at 33 sites conducted by the Erasmus Medical Center, Rotterdam, The Netherlands, where the efficacy and safety of Emcitate was investigated in 67 patients with MCT8 deficiency.

Based on the new long-term data, Egetis had further positive interactions with the regulatory agencies in the US and Europe. In December 2021, the EMA concluded that the clinical data from the Triac Trial I, together with the published data from long-term

treatment, will suffice for a regulatory submission of a Marketing Authorisation Application (MAA) to the EMA for the treatment of MCT8 deficiency. Egetis plans to submit the MAA in the second quarter of 2023.

In positive regulatory interactions, FDA acknowledges that a treatment effect on T3 levels and the manifestations of chronic thyrotoxicosis in MCT8 deficiency could provide a basis for marketing approval also in the US. Egetis has agreed with the FDA to perform a small, randomized study in 16 patients for up to 30 days to verify the T3 results, seen in previous clinical trials and publications. The design of this study (ReTRIACt) is now available on clinicaltrials.gov under the code NCT05579327. It is well established that the T3 levels in untreated MCT8 patients are significantly elevated, and we have previously shown that Emcitate is able to normalize these levels rapidly and durably. The primary source of patients will be through our existing named patient program. Egetis is targeting an US NDA submission for Emcitate in the second half of 2023 under the Fast Track Designation granted by the FDA.

A Phase IIb/III early intervention study (Triac Trial II) was initiated in 2020. This study is an international, open label, multi-center study in boys younger than 30 months with MCT8 deficiency, conducted in both Europe and North America. The design of the Triac

Trial II study is available on clinicaltrials.gov under the code NCT02396459. The recruitment target was reached in April 2022, with 22 patients now included in the study. Results from the Triac Trial II are expected in mid 2024 and are expected to be submitted postapproval to regulatory authorities.

Emcitate is already supplied to over 170 patients on a named patient or compassionate use basis, following individual regulatory approvals from national regulatory agencies in over 25 countries. Compassionate use and named patient programs are mechanisms to allow early access to a medicine prior to regulatory marketing approval, granted to pharmaceuticals under development for conditions with high unmet medical needs and where no available treatment alternatives exist.

Emcitate has been granted orphan drug designation (ODD) for RTH-β in the USA and the EU. RTH-β is an additional indication, without overlap in patient populations, to the previously obtained ODD for MCT8 deficiency. The ODD for RTH-β is a direct result of Egetis' work to extend the indications for the Emcitate program to related but distinct conditions.

Aladote

Events during the quarter

Preparations for the pivotal Albatross study

About Aladote

Aladote is a first-in-class drug candidate with the potential to reduce the risk of acute liver failure associated with paracetamol/acetaminophen poisoning. Aladote has shown a beneficial effect in relevant preclinical models, even in the timewindow when N-acetylcysteine (NAC) treatment no longer is effective (>8 hours). A proof of principle study in patients with paracetamol poisoning to prevent acute liver injury has been successfully completed. The study results established the safety and tolerability of the combination of Aladote and NAC. Further, the results indicate that Aladote may reduce acute liver injury in this patient population.

Aladote has been granted Orphan Drug Designation (ODD) in the US and EU.

Paracetamol/acetaminophen is the most used drug in the world for the treatment of fever and pain, but also one of the most overdosed drugs – intentionally or unintentionally. Paracetamol overdose is one of the most common methods in

suicide attempts. When excessive amounts of paracetamol are metabolized in the liver, the harmful metabolite N-acetyl-p-benzoquinone imine (NAPQI) is formed, which can cause acute liver failure. The current standard of care for paracetamol poisoning, NAC, is effective if the patient receives medical care within eight hours of ingestion.

A pivotal Phase IIb/III study, Albatross, is expected to start in 2023 and is targeting patients with increased risk of liver injury, who arrive late at hospital, more than eight hours after a paracetamol overdose, for which current standard of care, NAC, is substantially less effective. The total planned number of patients is around 250, who will be enrolled in the US, UK and in at least one EU country. The study consists of two parts with an interim analysis which includes a futility analysis and dose selection where the most effective dose will be continued. Applications for market approval in the US, EU and UK are planned after successful completion of the study.

Financial Information

Year-end report January – December 2022

Revenues and results

Revenues

Total revenues amounted to MSEK 5,7 (3,5) during the quarter and MSEK 22,6 (38,5) for the period. The revenues consisted of Emcitate sales of MSEK 5,7 (3,2) during the quarter and MSEK 21,9 (15,7) during the period. Forwarding of expenses related to PledOx to Solasia Pharma K.K. (Solasia) amount to MSEK 0,0 (-) during the quarter and MSEK 0,6 (22,6) during the period.

Expenses

Operating expenses amounted to MSEK -83,9 (-36,1) during the quarter and MSEK -220,6 (-144,2) during the period. The project expenses amounted to MSEK -52,8 (-18,5) during the quarter and MSEK -136,3 (-88,7) during the period. The project expenses consisted of expenses due to Emcitate of MSEK -49,9 (-15,3), Aladote MSEK -2,8 (-2,9) and PledOx MSEK -0,1 (-0,3) for the quarter and MSEK -124,6 (-37,3) for Emcitate, Aladote MSEK -10,6 (-19,0) and PledOx MSEK -1,1 (-32,4) for the period.

Employee costs amounted to MSEK -21,4 (-10,5) during the quarter and MSEK -52,0 (-30,1) for the period. The costs include participants' earnings in the employee stock option plans of MSEK -8,8 (-1,2) for the period.

Other external costs amounted to MSEK -6,4 (-3,8) for the quarter and MSEK -22,3 (-14,5) for the period. The increase is mainly due to higher consultancy costs. Depreciation amounted to MSEK -0,7 (-0,7) for the quarter and MSEK -2,7 (-2,5) for the period. The depreciation during the period derives from amortization of licences with MSEK -1,1 (-1,0), depreciation of right-of-use assets with MSEK -1,5 (-1,3) and depreciation of inventories with MSEK -0,1 (-0,2). Other operating expenses amounted to MSEK -1,3 (-0,2) for the quarter and MSEK -1,1 (-0,6) for the period and consists of exchange rate differences from operating income and operating expenses.

Results

Operating results amounted to MSEK -78,2 (-32,6) for the quarter and MSEK -198,1 (-105,7) for the period. Net financial items amounted to MSEK 0,4 (0,6) for the quarter and MSEK 4,3 (1,1) for the period. Results from net financial items are related to unrealized revaluation of company's FX-accounts. Results after financial items amounted to MSEK -77,8 (-32,1) for the quarter and MSEK -193,8 (-104,5) for the period. Result per share before and after dilution amounted to SEK -0.4 (-0.2) for the quarter and SEK -1.0 (-0.6) for the period both before and after dilution.

Financial position

Cash

Cash as of December 31, 2022, amounted to MSEK 127,7 (144,0).

Cash flow

Cash flow from operating activities amounted to MSEK -62,4 (-26,0) for the quarter and MSEK -173,5 (-130,1) for the period. Total Cash flow amounted to MSEK -62,8 (-29,6) for the quarter and MSEK -19,5 (-145,0) for the period. Cash flow from operating activities is driven by costs related to the projects.

Cash flow from investment activities amounted to MSEK -1,7 (-6,0) during the period and are due to the RTT deferred purchase price. Cash flow from financing activities amounted to MSEK -0,4 (-2,3) for the quarter and 155,7 (-8,9) for the period and derives mainly from the rights issue that was completed during May 2022.

Equity and equity ratio

As of December 31, 2022, equity amounted to MSEK 506,2 (527,0). Shareholders' equity per share amounted to SEK 2.6 (2.9), at the end of the period. The company's equity ratio was 90 (93) %.

Debts and receivables

As of December 31, 2022, non-current liabilities amounted to MSEK 5,5 (3,1). These consist mainly of liabilities that derive from right of use liabilities according to IFRS 16 of MSEK 1,1 (2,7) and long-term liabilities of MSEK 4,4 (0,4). Current liabilities amount to MSEK 49,4 (39,2) of which other liabilities amount to

MSEK 29,4 (34,6) and accounts payable amount to MSEK 20,0 (4,6).

Investments in, tangible and intangible assets

As of December 31, 2022, non-current intangible assets amounted to MSEK 412,8 (415,4). No significant investments were allocated to tangible assets.

Shares

The number of shares as of December 31, 2022, were 214,589,128 (165,068,560). The number of shares has increased during the period with 49,520,568 shares as a result of a new share issue. The number of shareholders were 6,474 as of December 31, 2022. The 10 largest shareholders hold 63.2 % of outstanding shares. Egetis Therapeutics shares are listed on Nasdaq Stockholm's main market.

Stock option plan and warrant programs Information regarding existing incentive programs.

For information about current and previous employee stock option programs please see note 6.

Employees

Number of employees as of December 31, 2022, were 17 (12) persons, 10 women and 7 men (7 women and 5 men).

Parent company

The parent company's revenues for the quarter amounted to MSEK 0,0 (-) and for the period to MSEK 0,6 (22,6) and are due to forwarding of expenses related to PledOx to Solasia. Other income for the quarter amounted to MSEK 22,0 (6,2) and for the period to MSEK 53,6 (16,2). Other income for the period consisted of MSEK 27,7 (12,5) management fees invoiced to the subsidiary RTT, MSEK 25,5 (3,7) are forwarding of expenses to RTT and MSEK 0,4 (0,0) exchange rate gains.

Operating expenses amounted to MSEK -46,0 (-18,4) during the quarter and MSEK -117,4 (-100,0) for the period. The project expenses amounted to MSEK -17,7 (-4,0) for the quarter and MSEK -42,4 (-55,0) during the period.

The parent company's result amounted to MSEK -104,3 (-56,4) for the quarter and MSEK -194,5 (-128,0) for the period.

Financial non-current assets amount to MSEK 433,8 (432,7) and long-term liabilities amount to MSEK 4,4 (0,4).

Consolidated statement of comprehensive income

MSEK	2022	2021*	2022	2021*
	Oct-Dec	Oct-Dec	Jan-Dec	Jan-Dec
Revenue Revenues	5,7	3,2	22,6	38,2
Other operating income	0,0	0,3	0,0	0,3
Total revenue	5,7	3,5	22,6	38,5
Operating expenses
Costs of sales of goods	-1,3	-2,5	-6,3	-7,9
Project costs	-52,8	-18,5	-136,3	-88,7
Other external costs	-6,4	-3,8	-22,3	-14,5
Employee costs	-21,4	-10,5	-52,0	-30,1
Depreciation and impairment	-0,7	-0,7	-2,7	-2,5
Other operating expenses	-1,3	-0,2	-1,1	-0,6
Sum operating expenses	-83,9	-36,1	-220,6	-144,2
Operating results	-78,2	-32,6	-198,1	-105,7
Financial items
Interest income and similar items	1,0	1,2	5,0	1,3
Interest expense and similar items	-0,6	-0,7	-0,7	-0,2
Sum financial items	0,4	0,6	4,3	1,1
Results after financial net	-77,8	-32,1	-193,8	-104,5
Tax	-	-	-	-
Results after tax	-77,8	-32,1	-193,8	-104,5
Statement of comprehensive income Other comprehensive income	0,0	-	0,0	-
Comprehensive income for the period	-77,8	-32,1	-193,8	-104,5
Net earnings and comprehensive income
are entirely attributable to parent
company shareholders
Share Data
Number of shares at the end of period Average number of shares during period,	214,589,128	179,906,457	214,589,128	179,906,457
before dilution	214,589,128	179,906,457	194,238,210	179,906,457
Average number of shares during period,
after dilution	215,390,155	179,906,457	194,238,210	179,906,457
Earnings per share before dilution (SEK)	-0.4	-0.2	-1.0	-0.6
Earnings per share after dilution (SEK)	-0.4	-0.2	-1.0	-0.6
Equity per average number of shares Equity per average number of shares after	2.4 2.4	2.9 2.9	2.6 2.6	2.9 2.9
dilution

*) The comparative figures in the table have been adjusted for the share issue in May 2022.

Consolidated statement of financial position

MSEK	31/12/2022	31/12/2021
ASSETS
Non-current assets
Research and development costs	404,8	404,8
Licences	5,4	6,5
Right-of-use assets	2,6	4,1
Equipment	0,1	0,2
Financial non-current assets	0,8	0,8
Total non-current assets	413,7	416,4
Current assets
Inventories	0,6	0,7
Accounts receivables	3,8	3,5
Other receivables	6,4	3,3
Prepaid expenses and accrued income	8,9	1,4
Cash and bank balance	127,7	144,0
Total current assets	147,4	152,9
Total assets	561,1	569,3

MSEK	31/12/2022	31/12/2021
Equity
Share capital	11,3	8,7
Other capital contributions	1 428,4	1 262,8
Reserves	6,1	1,3
Accumulated loss including net loss	-939,6	-745,8
Total equity	506,2	527,0
Non-current liabilities
Other non-current liabilities	1,1	2,7
Provisions	4,4	0,4
Total non-current liabilities	5,5	3,1
Current liabilities
Accounts payable	20,0	4,6
Other liabilities	5,7	17,2
Accrued expenses and deferred income	23,7	17,4
Total current liabilities	49,4	39,2
Total equity and liabilities	561,1	569,3

Consolidated statement of cash flows

MSEK	2022	2021	2022	2021
	Oct-Dec	Oct-Dec	Jan-Dec	Jan-Dec
OPERATING ACTIVITIES
Result after financial net	-77,8	-32,1	-193,8	-104,5
Adjustments for non-cash items	5,4	0,3	9,4	2,7
Tax paid	-	-	-	-
Cash flow from operating activities before	-72,4	-31,8	-184,4	-101,9
changes in working capital
Cash flow from changes in working capital
Increase/decrease in operating receivables	-6,6	1,3	-10,7	3,1
Increase/decrease in operating liabilities	16,6	4,5	21,6	-31,3
Cash flow from changes in working capital	10,1	5,8	10,9	-28,3
Cash flow from operating activities	-62,4	-26,0	-173,5	-130,1
INVESTING ACTIVITIES
Acquisition of subsidiaries, net cash required	-	-1,3	-1,7	-5,0
Investment in financial assets	0,0	-	0,0	-0,8
Purchase of property, plant and equipment	-	-0,1	-	-0,2
Cash flow from investing activities	0,0	-1,3	-1,7	-6,0
FINANCING ACTIVITIES
New share issue	-	-	177,4	0,0
Cost new share issue	-	-	-12,6	0,0
Repayment of loans	-	-1,9	-7,5	-7,5
Repayment of leases	-0,4	-0,4	-1,6	-1,4
Cash flow from financing activities	-0,4	-2,3	155,7	-8,9
Cash flow for the period				-145,0
	-62,8	-29,6	-19,5
Balance at beginning of period	190,1	173,2	144,0	287,9
Change in cash	-62,8	-29,6	-19,5	-145,0
Exchange rate difference in cash	0,4	0,4	3,2	1,1
CASH BALANCE AT THE END OF THE PERIOD	127,7	144,0	127,7	144,0

Consolidated statement of changes in equity

MSEK	Share capital	Other capital contributions	Accumulated loss incl. net results for the period	Other reserves	Total equity
Opening balance 01/01/2022	8,7	1 262,8	-745,8	1,3	527,0
Rights issue	2,6	178,1	-	-	180,8
Costs, rights issue	-	-12,6	-	-	-12,6
Comprehensive income for the period	-	-	-193,8	-	-193,8
Costs due to share-based payments of employee stock option plan	-	-	-	4,8	4,8
Closing balance 31/12/2022	11,3	1 428,4	-939,6	6,1	506,2
Opening balance 01/01/2021	8,7	1 262,8	-641,2	0,4	630,7
Comprehensive income for the period	-	-	-104,5	-	-104,5
Costs due to share-based payments of
employee stock option plan	-	-	-	1,0	1,0
Closing balance 31/12/2021	8,7	1 262,8	-745,8	1,3	527,0

Consolidated key ratios

The key ratios below are useful to those who read the financial statements and a complement to other performance targets in evaluating strategic investment implementation and the Group's ability to achieve financial goals and commitments.

	2022	2021
	Jan-Dec	Jan-Dec
Equity, MSEK	506,2	527,0
Equity ratio, %	90%	93%
Number of shares at the end of the period**	214,589,128	179,906,457
Average number of shares during the period**	194,238,210	179,906,457
Average number of shares during the period after dilution**	194,238,210	179,906,457
Share Data
Earnings per share**	-1.0	-0.6
Earnings per share after dilution**	-1.0	-0.6
Cash flow from operating activities**	-0.9	-0.7
Equity per average number of shares**	2.6	2.9
Equity per average number of shares after dilution**	2.6	2.9
Dividend	-	-
Average number of employees	15	11
*Effect from dilution is not considered when result is
negative.

** The comparative figures in the table have been adjusted for the share issue in May 2022.

Parent company - income statement

MSEK	2022	2021	2022	2021
	Oct-Dec	Oct-Dec	Jan-Dec	Jan-Dec
Revenue
Revenues	0,0	-	0,6	22,6
Other operating income	22,0	6,2	53,6	16,2
Total revenue	22,0	6,2	54,2	38,8
Operating expenses
Project costs	-17,7	-4,0	-42,4	-54,9
Other external costs	-6,7	-3,8	-22,4	-14,4
Employee costs	-21,4	-10,5	-52,0	-30,2
Depreciation and impairment	0,0	0,0	-0,1	0,0
Other operating expenses	-0,2	-0,1	-0,6	-0,5
Sum operating expenses	-46,0	-18,4	-117,4	-100,0
Operating results	-24,0	-12,1	-63,2	-61,3
Financial items
Interest income and similar items	-0,3	1,2	3,7	1,3
Interest expense and similar items	0,0	-0,5	0,0	-
Sum financial items	-0,3	0,7	3,7	1,3
Results after financial net	-24,3	-11,4	-59,5	-60,0
Appropriations	-80,0	-45,0	-135,0	-68,0
Tax	-	-	-	-
Results after tax	-104,3	-56,4	-194,5	-128,0

Parent company - balance sheet

MSEK	31/12/2022	31/12/2021
ASSETS
Non-current assets
Equipment	0,1	0,2
Financial non-current assets	433,8	432,7
Total non-current assets	433,9	432,9
Current assets
Receivables from Group companies	0,1	-
Other receivables	0,6	0,8
Prepaid expenses and accrued income	3,8	1,3
Cash and bank balance	120,0	138,9
Total current assets	124,4	141,0
Total assets	558,3	573,8

MSEK	31/12/2022	31/12/2021
Equity
Share capital	11,3	8,7
Non-restricted equity
Share premium reserve	673,8	636,2
Reserves	6,1	1,3
Net loss for the period	-194,5	-128,0
Total equity	496,7	518,2
Non-current liabilities
Provisions	4,4	0,4
Total non-current liabilities	4,4	0,4
Current liabilities
Liabilities to group company	33,1	38,2
Accounts payable	7,8	2,0
Other liabilities	3,9	7,6
Accrued expenses and deferred income	12,4	7,4
Total current liabilities	57,2	55,2
Total equity and liabilities	558,3	573,8

Notes

Note 1 - Accounting principles

Egetis applies International Financial Reporting Standards (IFRS) as adopted by the EU. This report is prepared in accordance with IAS 34 Interim Financial Reporting and the Annual Accounts Act and should be read together with the Egetis consolidated financial statements for the year ended December 31, 2021. The interim report does not include all disclosures that would otherwise be required in a complete set of financial statements. Applied accounting principles and calculation methods are the same as in the latest annual report for 2021. Some amendments to existing standards became applicable from January 1, 2022, however none of these have a material impact on the consolidated financial statements or accounting policies. The parent company and the Group's accounting currency is SEK. All the numbers in this interim report are, if nothing else is stated, presented in million SEK.

The preparation of interim reports requires certain critical accounting estimates to be made. Furthermore, company management is required to make assessments when applying accounting principles. See the Group's accounting principles in the annual report 2021 regarding more information on estimates and assessments.

Parent company

The parent company Egetis Therapeutics AB (publ.) prepares financial reports in accordance with the Swedish Financial Reporting Board's recommendation RFR 2 Accounting for Legal Entities and the Swedish Annual Accounts Act. The parent company applies the exception from application of IFRS 16 Leases.

Operating risks

All business operations involve risk. Risks may be company specific or due to events in the external environment and may affect a certain industry or market. The group is, among others, exposed to the following operational and financial risks.

Operational risks:

Pharmaceutical development, Manufacturing, Regulatory, Commercialization, Competition and Market Acceptance and Intellectual property.

Financial risks:

Foreign currency, Need of working capital, General market risk, Credit and Interest rate risks.

A more detailed description of the Group's risk exposure is included in Egetis 2021 Annual Report, Risk section. There are no major changes in the Group's risk exposure in 2022 compared with 2021.

External risk factors

There is a risk that the Company, as a result of COVID-19, will not succeed in recruiting participants for its clinical studies, either because participants do not want, or due to restrictions should not, visit hospitals to avoid infection. There is also a risk that new variants of the coronavirus will lead to lockdowns in Sweden or in other countries, which could mean that the Company or its partners cannot conduct research and development work according to the existing clinical development plan. There is also a risk that caregivers need to allocate resources to meet the effects of the coronavirus, which can lead to limited resources to participate in the Company's clinical trials.

In 2021, escalating tension between Russia and Ukraine led to Russia's full-scale military invasion of Ukraine. A continuation and/or further escalation of the conflict could have a significant negative impact on the global macroeconomic situation and the Swedish economy. It could result in the Company or its partners not being able to run R&D work according to plan.

A more detailed description of the Group's risk exposure is included in Egetis 2021 Annual Report, Note 3. There are no major changes in the Group's risk exposure in 2022 compared with 2021.

Note 2 – Additional information

Other information in accordance with IAS 34.16A are found on the pages before the income statement and statement of comprehensive income. For information on earnings, cash flow and financial position, see page 8. For events after the period, see page 1.

Note 3 – Segments

Note 3 – Segments						The Group applies segment reporting with mainly two independent development areas, Emcitate and Aladote. The highest executive decision-maker in the Company allocates the Company's resources between these two R&D projects. Revenue for Emcitate is attributable to the "Named Patient Use" use of the drug candidate.
2022						Revenues and expenses attributable to Emcitate, Aladote and PledOx are reported below. As the Company has decided to park the PledOx project, comparative figures will only be presented when these are necessary. Revenues for PledOx consist of re-invoicing of costs attributable to the Asian part of the POLAR studies. 2021
Oct-Dec						Oct-Dec
MSEK	Emcitate	Aladote	PledOx	Common	Sum	MSEK	Emcitate	Aladote	PledOx	Common	Sum
Revenues	5,7	-		0,0 -	5,7	Revenues	3,2	-	-	-	3,2
Costs of sales of goods	-1,3	-		- -	-1,3	Costs of sales of goods	-2,5	-	-	-	-2,5
Project costs	-49,9	-2,8	-0,1	-	-52,8	Project costs	-15,3	-2,9	-0,3	-	-18,5
Other	-	-	-	-29,8	-29,8	Other	-	-	-	-14,8	-14,8
Operating results	-45,5	-2,8	0,0	-29,8	-78,2	Operating results	-14,6	-2,9	-0,3	-14,8	-32,6
Net financial items					0,4	Net financial items					0,6
Pretax profit					-77,8	Pretax profit					-32,1
2022 Jan-Dec						2021 Jan-Dec
MSEK	Emcitate	Aladote	PledOx	Common	Sum	MSEK	Emcitate	Aladote	PledOx	Common	Sum
Revenues	21,9	-		0,6 -	22,6	Revenues	15,7	-	22,6	-	38,2
Costs of sales of goods	-6,3	-	-	-	-6,3	Costs of sales of goods	-7,9	-	0,0	-	-7,9

Net financial items					0,4	Net financial items					0,6
Pretax profit					-77,8	Pretax profit					-32,1
Jan-Dec						Jan-Dec
MSEK	Emcitate	Aladote	PledOx	Common	Sum	MSEK	Emcitate	Aladote	PledOx	Common	Sum
Revenues	21,9	-		0,6 -	22,6	Revenues	15,7	-	22,6	-	38,2
Costs of sales of goods	-6,3	-	-	-	-6,3	Costs of sales of goods	-7,9	-	0,0	-	-7,9
Project costs	-124,6	-10,6	-1,1	-	-136,3	Project costs	-37,3	-19,0	-32,4	-	-88,7
	-	-	-	-78,0	-78,0	Other	-	-	-	-47,4	-47,4
Other
Operating results	-109,0	-10,6	-0,5	-78,0	-198,1	Operating results	-29,5	-19,0	-9,8	-47,4	-105,7
Net financial items					4,3	Net financial items					1,1

Turnover by type of revenue

	2022	2021	2022	2021
MSEK	Oct-Dec	Oct-Dec	Jan-Dec	Jan-Dec
Re-invoicing of
costs to Solasia	0,0	0,0	0,6	22,6
Sales of goods	5,7	3,2	21,9	15,7
Total	5,7	3,2	22,6	38,2

Note 4 – Contingent liabilities

Egetis has a contractual obligation, on future net sales from Emcitate, to provide royalty payments to the previous owners of Rare Thyroid Therapeutics International AB and Erasmus Medical Centre corresponding to a low double-digit percentage of net sales of the product.

Note 5 – Related party transactions

Peder Walberg has been providing consultancy services to the company, invoicing MSEK 1,7 (1,6) during the period. One member of the Board and two senior executives have received a smaller share of the guarantee remuneration in connection with the guaranteed rights issue completed in May 2022. These individuals' guarantee compensation was on worse terms than for external guarantors and corresponded to MSEK 0.3 out of a total of MSEK 4.0.

Note 6 – Employee Stock Option Plan

The average share price during the period has been lower than the subscription prices of the stock option plans, hence no dilution has been recognized to the shareholders. During the fourth quarter, the average share price exceeded the exercise price of the employee stock option program 2022 why a dilution effect is reported in the number of shares after dilution. However, as earnings per share are negative, no dilution is reported in the key ratio earnings per share after dilution. As of December 31, 2022, the company has three option plans outstanding. Full utilization of the plans would increase the number of shares in the company by 20,155,732.

Employee Stock option plan 2022

The 2022 Annual General Meeting resolved on a 2022/2026 stock option plan of 7,300,000 stock options for employees at Egetis Therapeutics, of which 6,942,384 were granted to employees and key consultants, as of September 30, 2022. The CEO and the rest of the management team (seven individuals) were granted 1,424,000 and 4,015,000 stock options, respectively. To ensure the delivery of shares to participants in the incentive plans as well as to cover social security contributions when the share awards and employee options are exercised, the Parent Company has issued 9,592,200 warrants to its subsidiary Egetis Therapeutics Incentive AB.

The option plan is implemented for employees and key consultants. The options were allotted free of charge to participants of the program. The options have a three-year vesting period calculated from the allotment date, provided that, with customary exceptions, the participants remain as employees of, or continue to provide services to Egetis. Once the options are vested, they can be exercised within a one-year period. Each vested option entitles the holder to acquire one share in Egetis at a predetermined price. The price per share is to be equivalent to 120% of the weighted average price that the company's shares were traded for on Nasdaq Stockholm during the ten trading days preceding the allotment date. The options have, at the time of issue, been valued according to the Black & Scholes valuation models. The exercise prices are SEK 4.22-7.15 per option.

Employee Stock option plan 2021

The 2021 Annual General Meeting resolved on a 2021/2025 stock option plan for employees at Egetis Therapeutics AB. After re-calculation for the May 2022 rights issue the number of outstanding and granted stock options are 5,100,000. To ensure the delivery of shares to participants in the Company's incentive plans as well as to cover social security contributions when the share awards and employee options are exercised, the Parent Company has issued 6,702,420 warrants to its subsidiary Egetis Therapeutics Incentive AB. After re-calculation for the May 2022 rights issue the updated exercise price is SEK 9.33 per option.

Employee Stock option plan 2020

The 2020 Annual General Meeting resolved on a 2020/2024 stock option plan for employees at PledPharma (previous company name for Egetis Therapeutics AB). After re-calculation for the November 2020 and May 2022 rights issues the number of granted stock options are 3,017,160. To ensure the delivery of shares to participants in the Company's incentive plans as well as to cover social security contributions when the share awards and employee options are exercised, the Parent Company has issued 3,997,841 warrants to its subsidiary Egetis Therapeutics Incentive AB. After re-calculation for the November 2020 and May 2022 rights issues the updated exercise price is SEK 11,71 per option.

Note 7 –Key ratios definitions

Ratios that have been calculated according to IFRS

Earnings per share. Net income divided by average number of shares before dilution.

Number of shares at end of period. The number of outstanding shares before dilution at the end of the period.

Number of shares after dilution. The number of issued shares after dilution effect of potential shares at end of period.

Average number of shares during the period. Average number of outstanding shares before dilution for the period.

Average number of shares during the period after dilution. Average number of issued shares after dilution effect of potential shares.

Project costs Refer to external costs that are directly attributable to the Group's costs regarding research and development of drug candidates.

Ratios that have not been calculated in accordance with IFRS The company defines the below ratios as follows.

Equity ratio, % The period's closing equity divided by the period's closing balance sheet. The Company uses the alternate Equity ratio as it shows the proportion of total assets represented by shareholders' equity and has been included to allow investors to assess the Company's capital structure.

Cash flow from operations per share. Cash flow from operating activities divided by the average number of shares outstanding at the end of the period. The Company uses the alternate key figure Cash flow from operations per share because the Company believes that the key ratio gives investors a better understanding of the Company's cash flow in relation to its number of shares adjusted for changes in the number of shares outstanding during the period.

Equity per share. Equity divided by number of shares outstanding at the end of the period. Outstanding stock options and warrants are only considered if they are "in the money". The Company uses the alternate key ratio equity per share because the Company believes that the key ratio gives investors a better understanding of the historical return per share adjusted for changes in the number of shares outstanding during the period.

		2022	2021*
		Jan-Dec	Jan-Dec
A	Equity, MSEK	506,2	527,0
B	Balance sheet total, MSEK	561,1	569,3
A/B	Equity ratio %	90%	93%
A	Net result, MSEK	-193,8	-104,5
B	Equity, MSEK	506,2	527,0
A/B	Return on equity, %	neg.	neg.
A	Cash flow from operating activities, MSEK	-173,5	-130,1
	Average number of shares under the period, before dilution,
B	thousand	194,238	179,906
A/B	Cash flow from operating activities per shares, SEK	-0.9	-0.7
A	Equity, MSEK	506,2	527,0
	Average number of shares at the end of the period before
B	dilution, thousand	194,238	179,906
	Equity per average number of shares before dilution,
A/B	SEK	2.6	2.9
A	Equity, MSEK	506,2	527,0
	Average number of shares at the end of the period after
B	dilution, thousand	194,238	179,906
A/B	Equity per average number of shares after dilution, SEK	2.6	2.9

Number of employees (average). The average number of employees at the end of each period

*) The comparative figures in the table have been adjusted for the share issue in May 2022.

Other information

Next reports

Interim report January 1- March 31, 2023, April 26, 2023 Annual General Meeting April 27, 2023. Half-year report January 1- June 30: August 22, 2023. Interim report January 1- September 30: November 8, 2023.

This report, and further information is available on the website, www.egetis.com This report has not been reviewed by the company's auditor. This is a translation of the Swedish interim report.

For further information, please contact:

Nicklas Westerholm, CEO Yilmaz Mahshid, CFO E-mail: nicklas.westerholm@egetis.com E-mail: yilmaz.mahshid@egetis.com

This information is such information as Egetis Therapeutics AB (publ.) is obliged to disclose in accordance with EU market abuse regulation and the Securities Markets Act. The information was submitted, through the above contact persons, for publication on February 22, 2023, at 7.00 am (CET).

Egetis Therapeutics AB (publ) Klara Norra kyrkogata 26, 111 22 Stockholm, Sweden Org.nr. 556706-6724 Phone: +46(0)8-679 72 10 www.egetis.com

Analysts who follow Egetis Therapeutics

ABGSC: Gonzalo Artiach Bryan, Garnier & Co: Alex Cogut Carnegie: Arvid Necander & Erik Hultgård Erik Penser Bank: Ludvig Svensson Pareto Securities: Dan Akschuti Redeye: Fredrik Thor Rx Securities: Joseph Hedden

Certification

This Year-end report for the January-December 2022 period provides a true and fair overview of the parent's and group's business activities, financial position, and results of operations, and describes significant risks and uncertainties to which the companies in the group are exposed.

Stockholm, February 22, 2023

Thomas Lönngren	Mats Blom
Chairman of the board	Board member

Board member Board member

Gunilla Osswald Elisabeth Svanberg

Board member CEO

Peder Walberg Nicklas Westerholm