Board Change • Jul 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Director Jakob Hansen was the last director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Apr 08
Nanexa AB (publ), Annual General Meeting, May 12, 2026 Nanexa AB (publ), Annual General Meeting, May 12, 2026, at 15:00 W. Europe Standard Time. Location: uppsala business park, rapsgatan 7, uppsala Sweden Announcement • Jun 24
Nanexa AB (publ) Announces Presentation of NEX-22 Phase I Data at the 85th ADA Scientific Sessions in Chicago Nanexa announced that the poster titled "A Single Ascending Dose Study of a Once-monthly Liraglutide Formulation in Participants with Type 2 Diabetes" was presented by the renowned diabetes researcher Dr. Hans de Vries, on Sunday, June 22, at the American Diabetes Association's 85th Scientific Sessions. The poster, which presented all data, including the 30 mg NEX-22 dose cohort, was very well received, and there has been significant interest in the first published clinical data with a once-montly long-acting injection of a GLP-1 drug. A 30 mg dose of NEX-22 shows exposure for up to 36 days without significant gastrointestinal side effects. This is not only highly positive for NEX-22, but all other potential GLP-1/GIP formulations which make use of PharmaShell. The ADA's Scientific Sessions is the world's diabetes meeting, convening more than 11,000 attendees from around the globe to share cutting-edge scientific discoveries and advancements in diabetes care and innovation. Announcement • Apr 11
Eva Nilsagård Declines Re-Election to the Board of Nanexa AB (Publ) Eva Nilsagård has declined re-election to the board of Nanexa AB (publ). Announcement • Mar 12
Nanexa AB Doses First Patient in the 30 Mg Dose Group in the Phase I Study with NEX-22 Nanexa AB announced that the first patient has been dosed in the 30 mg dose group in the ongoing Phase I study with NEX-22, the company's one-month formulation of liraglutide. The ongoing Phase I study evaluates the pharmacokinetics, safety and tolerability of NEX-22, which uses Nanexa's patented PharmaShell® technology to enable a controlled release of the drug over one month. Previous results from the study have shown promising safety and pharmacokinetic data, paving the way for this dose escalation. Announcement • Feb 17
Nanexa AB (publ), Annual General Meeting, May 15, 2025 Nanexa AB (publ), Annual General Meeting, May 15, 2025. Announcement • Feb 13
Nanexa AB (publ) to Report Q1, 2025 Results on May 06, 2025 Nanexa AB (publ) announced that they will report Q1, 2025 results on May 06, 2025 Announcement • Jan 28
Nanexa AB Expands Phase I Study with NEX-22 with an Additional Dose Group Nanexa AB announced that the phase I study with NEX-22, the company's one-month formulation of liraglutide, will resume with further dose escalation with an expected start in the first quarter of 2025. The study will now continue to include patients after receiving regulatory approval to add a dose group for the administration of 30 mg liraglutide. The study is being conducted, as before, in patients with type 2 diabetes who have not previously been treated with GLP-1 drugs, at Profil, a diabetes CRO in Germany. As announced in November, the study has completed three cohorts with escalating doses up to 10 mg in order to assess the pharmacokinetic profile, safety and tolerability of different dose levels. The depot formulation NEX-22 is administered as an injection under the skin (subcutaneously). Results from a fourth cohort are expected in the second quarter of 2025. Announcement • Nov 23
Nanexa AB Announces Positive Results in the Phase I Study for NEX-22, Long Acting GLP-1, in Type 2 Diabetes Nanexa AB announced positive results in the company's Phase I study for NEX-22, long acting GLP-1, in type 2 diabetes. The study evaluates a once-monthly depot formulation of the GLP-1 analog liraglutide with Nanexa's patented PharmaShell® system. The study met all primary and secondary endpoints. The pharmacokinetic profile supports a one-month depot of liraglutide, with dose linearity for both Cmax, AUC and depot length. No adverse events reported, including no incidences of nausea or vomiting. No or minimal local reactions was observed. The study was performed at Profil, a world leading diabetes CRO, in Germany and was conducted in type-2 diabetes patients naive to GLP-1 treatment. It included three patients in each of three consecutive cohorts with escalating doses, aiming to assess the pharmacokinetic profile, safety, and tolerability of different dose levels. The first cohort was dosed in June 2024 and the last patient last visit was November 5. The NEX-22 depot formulation was administered as an injection under the skin (subcutaneously). Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of drugs used for the treatment of type 2 diabetes and obesity. Liraglutide is a GLP-1 agonist developed by Novo Nordisk and included in currently marketed products Victoza and Saxenda, which both require daily injections. Reported Earnings • Nov 09
Third quarter 2024 earnings released: kr0.03 loss per share (vs kr0.11 loss in 3Q 2023) Third quarter 2024 results: kr0.03 loss per share (improved from kr0.11 loss in 3Q 2023). Revenue: kr11.2m (down 19% from 3Q 2023). Net loss: kr4.44m (loss narrowed 34% from 3Q 2023). Revenue is expected to decline by 80% p.a. on average during the next 2 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.0%. Over the last 3 years on average, earnings per share has increased by 16% per year but the company’s share price has fallen by 44% per year, which means it is significantly lagging earnings. Announcement • Nov 05
Nanexa AB (Publ) Completes Phase I Trial of NEX-22 in Type 2 Diabetes Nanexa AB announced that all patients have now completed the company's Phase I study for NEX-22 in type 2 diabetes. The study evaluates a long-acting depot formulation of the GLP-1 analog liraglutide with Nanexa's patented PharmaShell®? system. All patients' visits to the study clinic have now been completed according to plan. The analysis of the last blood samples taken is now the only thing that remains, as part of the evaluation of the pharmacokinetic profile of the treatment. The target is to have a one-month depot formulation to simplify and improve patients' adherence to prescribed treatment, and in the end achieve a better outcome. New Risk • Nov 01
New minor risk - Revenue size The company makes less than US$5m in revenue. Total revenue: kr53m (US$5.0m) This is considered a minor risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr58m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (124% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (kr12m net loss next year). Revenue is less than US$5m (kr53m revenue, or US$5.0m). Market cap is less than US$100m (€17.7m market cap, or US$19.2m). Announcement • Sep 17
Nanexa AB (Publ) Announces That the First Patient in the Third Dose Group with Their Long-Acting Depot Formulation of the Glp-1 Analog Liraglutide Has Been Dosed Nanexa AB (publ) announced that the first patient in the third dose group with their long-acting depot formulation of the GLP-1 analog liraglutide has been dosed. The study started in June 2024 and have so far studied two consecutive dose groups with escalating doses. Preliminary data from the first two dose groups shows that Nanexa’s PharmaShell® technology enables a controlled and prolonged release of liraglutide, with an increase in plasma concentration proportional to dose. A good safety profile has been observed, with only mild injection site reactions. In parallel activities are ongoing for further development of the PharmaShell® formulation and prepare for the next step in the clinical development program of NEX-22. In the study, the long-acting formulation of NEX-22 is administered by subcutaneous injection (injection under the skin). The study is designed to include several consecutive groups with escalating doses aimed at evaluating the pharmacokinetic profile, safety and tolerability of different doses. Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of drugs for the treatment of type 2 diabetes and obesity. Liraglutide is a GLP-1 analog in the marketed products Victoza and Saxenda given as daily injections. New Risk • Aug 28
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: kr67m Forecast net loss in 1 year: kr12m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr58m free cash flow). Share price has been highly volatile over the past 3 months (23% average weekly change). Shareholders have been substantially diluted in the past year (124% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (kr12m net loss next year). Market cap is less than US$100m (€19.3m market cap, or US$21.5m). Reported Earnings • Aug 28
Second quarter 2024 earnings released: kr0.04 loss per share (vs kr0.16 loss in 2Q 2023) Second quarter 2024 results: kr0.04 loss per share (improved from kr0.16 loss in 2Q 2023). Revenue: kr10.8m (down 37% from 2Q 2023). Net loss: kr6.01m (loss narrowed 40% from 2Q 2023). Revenue is expected to decline by 64% p.a. on average during the next 2 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.4%. Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 37% per year, which means it is significantly lagging earnings. Announcement • Aug 01
Nanexa's Phase I Trial of NEX-22 in Type 2- Diabetes Progresses with Next Dose Group According to Plan Nanexa AB announced that the company's Phase 1 study for type 2 diabetes continues dose escalation according to plan with their long-acting depot formulation of the GLP-1 analog liraglutide. The appointed dose escalation committee of the study has been able to make the judgement to continue dosing in the next treatment group, based on data from patients in the first treatment group. In the study, the long-acting formulation of NEX-22 is administered by subcutaneous injection. The study is designed to include several consecutive groups with escalating doses aimed at evaluating the pharmacokinetic profile, safety and tolerability of different doses. Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of drugs for the treatment of type 2 diabetes and obesity. Liraglutide is a GLP-1 analog in the marketed products Victoza and Saxenda given as daily injections. Announcement • Jun 28
Nanexa AB (publ) Announces Chief Financial Officer Changes Nanexa AB (publ) announced that Cecilia Danckwardt-Lillieström will take over as Chief Financial Officer as of September 1, 2024, as the current CFO Björn Svanström has chosen to leave the company. Cecilia has extensive experience from similar positions in the Life Science sector as well as senior roles in accounting and auditing. Cecilia holds a degree in Economics and Business Administration from Uppsala University. Announcement • Jun 13
Nanexa AB (Publ) Announces That First Patient Dosed in Nanexa's Phase I Trial of NEX-22 in Type 2 Diabetes Nanexa AB announced that the company's Phase 1 study for type 2 diabetes has been initiated with dosing of the first patient. The study evaluates a long-acting depot formulation of the GLP-1 analog liraglutide with Nanexa's patented PharmaShell® system within the NEX-22 project. The study is a dose-escalation study aimed at evaluating the pharmacokinetic profile, safety and tolerability of different doses. The study is being conducted in Germany by the CRO Profil and is the first clinical study to investigate a long-acting formulation of a GLP-1 compound based on PharmaShell. The study is an open-label phase 1 study where the long-acting formulation is administered by subcutaneous injection. The study is designed to include several consecutive groups with escalating doses. The study includes both women and men with type 2 diabetes. The results of the study will provide important information for optimization of the formulation for future regulatory pharmacokinetic and efficacy studies in patients with type 2 diabetes. Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of drugs for the treatment of type 2 diabetes and obesity. As the prevalence of obesity and type 2 diabetes increases worldwide, the market for GLP-1 receptor agonists is also growing. In a recent report, GlobalData estimates that sales of GLP-1 receptor agonists for the type 2 diabetes and obesity markets will reach over $125 billion by 2033. Nanexa believes that the increased convenience of fewer injections than current options makes its formulation an attractive treatment option for the majority of patients. New Risk • Jun 05
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr74m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr74m free cash flow). Share price has been highly volatile over the past 3 months (31% average weekly change). Shareholders have been substantially diluted in the past year (124% increase in shares outstanding). Minor Risk Market cap is less than US$100m (€10.9m market cap, or US$11.8m). Announcement • May 17
Nanexa AB Receives Approval for NEX-22 Clinical Study Nanexa AB announced that the European Medicines Agency has approved the company's clinical trial application for the Phase I study with NEX-22. NEX-22 is a long-acting depot formulation of the GLP-1 analogue liraglutide with Nanexa's patented PharmaShell® system. The goal is to create a GLP-1 product that can be administered once a month in the treatment of Type 2 diabetes. The study will be performed in collaboration with the contract research organisation Profil in Germany, which is highly specialized in early clinical studies in diabetes and obesity. The study is divided into several consecutive dose groups where single doses of NEX-22 will be administered to patients with Type 2 diabetes to study pharmacokinetics, safety and tolerability. Liraglutide and other GLP-1 analogues have rapidly become important in the treatment of Type 2 diabetes and obesity. The global market for this type of products is very large and is growing with increasing prevalence of both Type 2 diabetes and obesity. Sales of GLP-1 compounds show strong growth and GLP-1 and GLP-1/GIP drugs are expected to reach sales of over USD 70 billion by 2029 for Type 2 diabetes. Announcement • May 16
Nanexa AB (publ) Elects Hanna Tilus as Members of the Board Nanexa AB (publ) at its AGM held on May 15, 2024, Hanna Tilus was elected as members of the board. Reported Earnings • May 05
First quarter 2024 earnings released: kr0.02 loss per share (vs kr0.14 loss in 1Q 2023) First quarter 2024 results: kr0.02 loss per share (improved from kr0.14 loss in 1Q 2023). Revenue: kr14.2m (up 5.4% from 1Q 2023). Net loss: kr2.82m (loss narrowed 67% from 1Q 2023). Revenue is forecast to grow 8.6% p.a. on average during the next 2 years, compared to a 6.8% growth forecast for the Medical Equipment industry in Germany. Announcement • Apr 16
Nanexa AB (publ) Announces Approval of Clinical Trial Application for NEX-22 Study Delayed Nanexa AB (publ) announced that in the ongoing review process of the clinical trial application for the phase I study with NEX-22, additional supplements have been requested from the German Medicines Agency, which in the new European regulatory process takes more time than expected. Nanexa is developing NEX-22, a one-month product of the GLP-1 substance liraglutide, for the treatment of type 2 diabetes. In December 2023, the company submitted a clinical trial application for a first phase I study with N EX-22 and was informed during the first quarter of 2024 that certain supplements and clarifications of the application were requested, and most of these clarifications were also accepted by the authority during the first quarter. A few remaining supplements were handled quickly by Nanexa, but with the new European system for reviewing clinical trials, a new submission of the application was required, which in itself has delayed the process. Nanexa has now received some additional questions from the authority based on the new review of the application. The company sees no difficulty in answering these, but the application will not be approved in April with the current timeline. New Risk • Feb 25
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 124% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (30% average weekly change). Shareholders have been substantially diluted in the past year (124% increase in shares outstanding). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr77m). Market cap is less than US$100m (€11.8m market cap, or US$12.8m). Reported Earnings • Feb 22
Full year 2023 earnings released: kr1.09 loss per share (vs kr1.16 loss in FY 2022) Full year 2023 results: kr1.09 loss per share. Revenue: kr59.5m (up 119% from FY 2022). Net loss: kr76.4m (loss widened 30% from FY 2022). Revenue is forecast to grow 6.8% p.a. on average during the next 2 years, compared to a 6.7% growth forecast for the Medical Equipment industry in Germany. Announcement • Jan 07
Nanexa AB (publ), Annual General Meeting, May 15, 2024 Nanexa AB (publ), Annual General Meeting, May 15, 2024. Announcement • Dec 21
Nanexa AB Announces Clinical Trial Application for NEX-22 Phase I Study Assess by EMA Nanexa AB announced that the Clinical Trial Application for the Phase I study of NEX-22 in patients with type 2 diabetes has been received and validated by the European Medicines Agency (EMA). Reported Earnings • Nov 24
Third quarter 2023 earnings released: kr0.11 loss per share (vs kr0.24 loss in 3Q 2022) Third quarter 2023 results: kr0.11 loss per share (improved from kr0.24 loss in 3Q 2022). Revenue: kr13.7m (up 52% from 3Q 2022). Net loss: kr6.69m (loss narrowed 44% from 3Q 2022). Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 6.3% growth forecast for the Medical Equipment industry in Germany. Announcement • Oct 06
Nanexa AB Completes Clinical Phase I Study with NEX-20 Nanexa AB announced that the phase I study NEX-20-01 has been completed with the last follow-up visits for the last of the three dose levels studied. Nanexa has previously communicated positive results from the pharmacokinetic evaluation and has now also completed the collection of safety and tolerability data that also supports the further development of the project. NEX-20-01 did not reveal any unexpected findings that question the safety of lenalidomide as a depot formulation with PharmaShell®. However, local reactions were observed with redness and/or swelling corresponding to the area of injection with the given formulation of NEX-20. The reactions ranged from mild at the lower dose levels to moderate at higher doses. All reactions subsided during the study period. The next step in the clinical program for NEX-20 is to proceed with dose escalation to therapeutic levels in patients. The formulation studied in NEX-20-01 shows a controlled release pharmacokinetic profile close to that required for once-monthly dosing. In parallel with the completed clinical study, a preclinical study has been conducted in minipigs with a new formulation of NEX-20 with significantly less swelling at the injection site compared to the formulation used in NEX-20-01. This formulation will be further developed and tested preclinically to minimize local reactions in the next clinical study. Reported Earnings • Aug 23
Second quarter 2023 earnings released: kr0.16 loss per share (vs kr0.32 loss in 2Q 2022) Second quarter 2023 results: kr0.16 loss per share (improved from kr0.32 loss in 2Q 2022). Revenue: kr17.2m (up 209% from 2Q 2022). Net loss: kr9.95m (loss narrowed 39% from 2Q 2022). Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 6.3% growth forecast for the Medical Equipment industry in Germany. Reported Earnings • Aug 23
Second quarter 2023 earnings released: kr0.16 loss per share (vs kr0.32 loss in 2Q 2022) Second quarter 2023 results: kr0.16 loss per share (improved from kr0.32 loss in 2Q 2022). Revenue: kr17.2m (up 209% from 2Q 2022). Net loss: kr9.95m (loss narrowed 39% from 2Q 2022). Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 6.3% growth forecast for the Medical Equipment industry in Germany. Announcement • May 11
Nanexa AB (Publ) Announces Urban Paulsson and Bengt Gustavsson Declines Re-Election Nanexa AB (publ) at its annual general meeting will be held on 9 June 2023, Urban Paulsson and Bengt Gustavsson have declined re-election. Reported Earnings • May 08
First quarter 2023 earnings released: kr0.14 loss per share (vs kr0.24 loss in 1Q 2022) First quarter 2023 results: kr0.14 loss per share (improved from kr0.24 loss in 1Q 2022). Revenue: kr14.3m (up 173% from 1Q 2022). Net loss: kr8.60m (loss narrowed 31% from 1Q 2022). Revenue is expected to decline by 125% p.a. on average during the next 2 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.5%. Reported Earnings • Feb 17
Full year 2022 earnings released: kr1.16 loss per share (vs kr1.01 loss in FY 2021) Full year 2022 results: kr1.16 loss per share (further deteriorated from kr1.01 loss in FY 2021). Revenue: kr28.2m (up 56% from FY 2021). Net loss: kr58.6m (loss widened 63% from FY 2021). Revenue is expected to decline by 105% p.a. on average during the next 2 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.2%. Announcement • Feb 16
Nanexa AB (publ) to Report Q4, 2022 Results on Feb 16, 2023 Nanexa AB (publ) announced that they will report Q4, 2022 results on Feb 16, 2023 Announcement • Dec 07
Nanexa Starts the Phase 1 Study of NEX-20 According to Plan Nanexa AB (publ) announced that the first dose of NEX-20 has been administrated in the Phase 1 study NEX-20-01. NEX-20-01 is a phase 1 study dosing a single injection of NEX-20 to healthy volunteers to follow the pharmacokinetic profile, safety, and tolerability. The study is designed to study different dose levels in sequential dose groups, based on data evaluated during the course of the study. NEX-20 is a long-acting formulation of lenalidomide based on Nanexa's drug delivery system PharmaShell®. Lenalidomide is an immunomodulatory compound targeting both cancer cells and their microenvironment (1). Currently patients take lenalidomide daily as an oral capsule for 21-28 days in 28-day cycles. Breakeven Date Change • Nov 16
No longer forecast to breakeven The analyst covering Nanexa no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of kr49.0m in 2023. New forecast suggests the company will make a loss of kr53.0m in 2023. Announcement • Nov 15
Nanexa Receives Approval to Start Clinical Trial with NEX-20 Nanexa AB announced that it has received approval from the Swedish Medical Products Agency to initiate a clinical trial of its drug candidate NEX-20, a long-acting formulation of lenalidomide, based on the PharmaShell® system, intended for the maintenance treatment of multiple myeloma cancer. The study is a Phase 1 trial to study the pharmacokinetic profile, safety and tolerability of NEX-20, in ascending doses in healthy volunteers. Approval from the Ethics Review Board (etikprövningsnämnden) has already been obtained and other activities to start the study are on track. Reported Earnings • Oct 26
Third quarter 2022 earnings released: kr0.24 loss per share (vs kr0.18 loss in 3Q 2021) Third quarter 2022 results: kr0.24 loss per share (further deteriorated from kr0.18 loss in 3Q 2021). Revenue: kr9.16m (up 151% from 3Q 2021). Net loss: kr12.0m (loss widened 52% from 3Q 2021). Revenue is expected to decline by 72% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 5.7%. Announcement • Sep 28
Nanexa AB (Publ) and Vitrivax, Inc Reach Agreement in Principle Nanexa AB (publ) and VitriVax Inc. filed a notice with the Court requesting that Nanexa's patent infringement lawsuit pending in the District of Delaware be stayed while the parties work to finalize settlement terms to which they have agreed in principle. Announcement • Sep 16
Nanexa AB (Publ) Launches NEX-22 Product Project to Address Huge Market Nanexa AB (publ) announced that it has decided to develop a long-acting formulation of liraglutide with PharmaShell® for the treatment of type 2 diabetes. NEX-22 will be the company's third proprietary product development project. Type 2 diabetes (T2D) is a highly prevalent disease, with around 50 million people diagnosed in the 7MM (seven largest markets in the Western world). The number of patients is steadily increasing (1) and T2D is one of the most common lifestyle diseases linked to unhealthy diet and lack of exercise. Sales of drugs for T2D is expected to reach $50 billion by 2022, of which GLP-1 analogues account for about $15 billion, which is expected to grow at about 10% per year over the period 2022-2029 (2). Patients currently treated with liraglutide take one daily injection. With Nanexa's unique PharmaShell technology, these doses may be replaced with only one injection per month. Despite the fact that non-treatment can lead to serious secondary disease, studies show that many type 2 diabetics do not take their medication as prescribed. In one study (3) of T2D patients, around 50% were found not to be following prescribed treatment. Reported Earnings • Aug 27
Second quarter 2022 earnings released: kr0.32 loss per share (vs kr0.33 loss in 2Q 2021) Second quarter 2022 results: kr0.32 loss per share. Revenue: kr5.65m (up 11% from 2Q 2021). Net loss: kr16.2m (loss widened 95% from 2Q 2021). Over the next year, revenue is expected to shrink by 28% compared to a 8.2% growth forecast for the Medical Equipment industry in Germany. Announcement • Aug 27
Nanexa AB (publ) to Report Nine Months, 2022 Results on Oct 25, 2022 Nanexa AB (publ) announced that they will report nine months, 2022 results on Oct 25, 2022 Announcement • Aug 26
Nanexa AB (publ) Receives Extended GMP-Certificate for the New Pilot Plant Nanexa AB (publ) announced that the company's new pilot plant in Uppsala has received certification from the Swedish Medical Products Agency for production of clinical trial material. Nanexa has since before a GMP-certificate for small scale production and release of clinical trial material. The new larger pilot plant is designed for larger scale and more efficient production, andalso to handle production of toxic as well as biological drug products with the Atomic Layer Deposition technology. In June 2022, the Swedish Medical Products Agency made an inspection of Nanexa's new pilot plant and updated quality system in order to issue a certificate for production and release of clinical trial material. The inspection was made without any major observations and, following the company's answers and actions in response to outstanding questions, the final approval and certificate was received on 25 August 2022. Board Change • Jun 17
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 4 independent directors. 5 non-independent directors. Independent Chairman of the Board Goran Ando was the last independent director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Announcement • May 26
Nanexa Receives Grant from VINNOVA for Study with Monoclonal Antibodies Nanexa AB announced that the company has been granted funding under the VINNOVA project "Verification in Test Center, Part III" for a maximum amount of SEK 290,000. The funds will be used for an internal research project at Nanexa with the aim of coating monoclonal antibodies (mAbs) with PharmaShell®. The project is entitled; "A proof-of-concept study of applying prolonged-release coatings onto monoclonal antibodies using the PharmaShell® technology". Breakeven Date Change • Apr 28
Forecast to breakeven in 2023 The analyst covering Nanexa expects the company to break even for the first time. New forecast suggests the company will make a profit of kr15.0m in 2023. Average annual earnings growth of 112% is required to achieve expected profit on schedule. Reported Earnings • Apr 21
First quarter 2022 earnings released: kr0.24 loss per share (vs kr0.29 loss in 1Q 2021) First quarter 2022 results: kr0.24 loss per share. Revenue: kr5.32m (up 5.3% from 1Q 2021). Net loss: kr12.4m (loss widened 86% from 1Q 2021). Over the next year, revenue is forecast to grow 143%, compared to a 11% growth forecast for the industry in Germany. Reported Earnings • Feb 18
Full year 2021 earnings: EPS in line with expectations, revenues disappoint Full year 2021 results: kr1.01 loss per share (up from kr1.09 loss in FY 2020). Revenue: kr18.2m (down 13% from FY 2020). Net loss: kr36.0m (loss widened 66% from FY 2020). Revenue missed analyst estimates by 100%. Over the next year, revenue is forecast to grow 38%, compared to a 12% growth forecast for the industry in Germany. Announcement • Feb 12
Nanexa AB Announces That the Company's Preclinical Investigation Nanexa AB announced that the company's preclinical investigation indicates the cause and a potential solution to the moderate skin reactions that arose in the clinical study with NEX-18. With these results, Nanexa is expanding its preclinical program to optimize the formulation of NEX-18. The project is expected to re-enter clinical phase next year. The inclusion of patients in the Phase 1 clinical trial of NEX-18, a long-acting injectable azacitidine using the PharmaShell technology, was paused in September 2021 due to moderate skin reactions at the injection site, and since October 2021, additional preclinical studies have been underway to clarify the cause. These complementary preclinical studies have so far shown that PharmaShell itself is not the cause of the skin reactions. The results also indicate a potential solution to the problem. Therefore, the company is now focusing on a reformulation of NEX-18 with the goal of taking the project forward with an optimized product. The reformulation will be studied further preclinically during 2022. Given continued positive results, the clinical phase of the project will then be resumed. As previously communicated, the clinical study preliminarily showed that PharmaShell works as expected in creating a beneficial pharmacokinetic profile. Board Change • Jan 05
High number of new directors Director Birgit Norinder was the last director to join the board, commencing their role in 2021. Announcement • Sep 26
Nanexa Announces Inclusion of Patients in its Phase I Study with NEX-18 Nanexa announced that the inclusion of patients in the company's phase I study with NEX-18, a depot formulation of 5-azacitidine, is paused due to moderate skin reactions at the injection site. The moderate skin reactions that have occurred differ slightly from the mild reaction that normally occurs after the administration of 5-azacitidine. To clarify the cause, Nanexa together with the clinics is conducting an investigation including biopsies of the affected skin. The investigation is expected to be concluded in fourth quarter of 2021. The study preliminarily shows that PharmaShell works as expected when it comes to creating a beneficial pharmacokinetic profile, which is in line with what has been shown in the preclinical studies. The interruption has no effect on the planning and preparation of Nanexa's other clinical project, NEX-20, with lenalidomide in multiple myeloma, or on ongoing partner activities. The work of selecting the next drug candidate for NEX-21 is also proceeding according to plan. Reported Earnings • Aug 21
Second quarter 2021 earnings released The company reported a soft second quarter result with increased losses and weaker control over costs, although revenues improved. Second quarter 2021 results: Revenue: kr5.12m (up 3.2% from 2Q 2020). Net loss: kr8.34m (loss widened 28% from 2Q 2020). Breakeven Date Change • Jul 27
Forecast to breakeven in 2023 The 2 analysts covering Nanexa expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr49.0m in 2023. Average annual earnings growth of 64% is required to achieve expected profit on schedule. Board Change • Jul 27
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Director Birgit Norinder was the last director to join the board, commencing their role in 2021. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • May 09
First quarter 2021 earnings released: kr0.29 loss per share (vs kr0.22 loss in 1Q 2020) The company reported a mediocre first quarter result with increased losses and weaker control over costs, although revenues improved. First quarter 2021 results: Revenue: kr5.05m (up 32% from 1Q 2020). Net loss: kr6.67m (loss widened 89% from 1Q 2020). Announcement • Mar 16
Nanexa Appoints Jonas Fransson as Head of Pharmaceutical Development Nanexa announced that the company has recruited Jonas Fransson as head of pharmaceutical development as part of a strengthening of the organization. Jonas Fransson has long and solid experience in drug development and will start on May 1 this year and will be part of Nanexa's management team. He most recently had the role of Director Biopharmaceutical Drug Product Development at SOBI, where he has been since 2006. Reported Earnings • Feb 20
Full year 2020 earnings released: kr1.09 loss per share (vs kr0.88 loss in FY 2019) The company reported a solid full year result with improved revenues and control over costs, although losses increased. Full year 2020 results: Revenue: kr21.0m (up 140% from FY 2019). Net loss: kr21.7m (loss widened 68% from FY 2019). 
