New Risk • May 04
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 15% This is considered a minor 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 Risk Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr72m). Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (kr400.6m market cap, or US$43.3m). Price Target Changed • Feb 10
Price target decreased by 8.7% to kr6.32 Down from kr6.92, the current price target is an average from 3 analysts. New target price is 108% above last closing price of kr3.03. Stock is down 2.9% over the past year. The company is forecast to post earnings per share of kr0.26 next year compared to a net loss per share of kr0.67 last year. Price Target Changed • Feb 06
Price target decreased by 10% to kr6.65 Down from kr7.42, the current price target is an average from 3 analysts. New target price is 138% above last closing price of kr2.79. Stock is down 7.6% over the past year. The company is forecast to post earnings per share of kr0.09 next year compared to a net loss per share of kr0.67 last year. New Risk • Feb 06
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -kr72m This is considered a minor 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 Shareholders have been substantially diluted in the past year (32% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr72m). Market cap is less than US$100m (kr349.5m market cap, or US$38.6m). Tillkännagivande • Jan 23
Ascelia Pharma AB (publ) Announces Departure of Julie Waras Brogren as Deputy CEO Ascelia Pharma AB (publ) announced that Deputy CEO Julie Waras Brogren will leave the company to take up a CEO position in another company. Julie Waras Brogren joined Ascelia Pharma in January 2020 as Chief Commercial Officer and became Deputy CEO in October 2022. Since August 2023, she has also held the role of CFO. Julie will stay with Ascelia Pharma to ensure a successful transition of activities and to support the onboarding of the new incoming CFO, Anton Hansson. Tillkännagivande • Dec 23
Ascelia Pharma AB (publ), Annual General Meeting, May 04, 2026 Ascelia Pharma AB (publ), Annual General Meeting, May 04, 2026. Breakeven Date Change • Nov 11
Forecast breakeven date pushed back to 2026 The 3 analysts covering Ascelia Pharma previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 8.1% to 2025. The company is expected to make a profit of kr32.2m in 2026. Average annual earnings growth of 98% is required to achieve expected profit on schedule. Tillkännagivande • Nov 10
Ascelia Pharma AB (Publ) Files New Patent Application for Orvigance Ascelia Pharma AB (publ) announced the filing of a new patent application for its first-in-class orphan liver imaging drug Orviglance. In line with the strategy for Orviglance, the company has turned manufacturing knowledge and innovations into a patent application that, subject to approval and granting, further strengthens the market protection for Orviglance until 2046. New Risk • Oct 13
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 32% 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 Shareholders have been substantially diluted in the past year (32% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr71m). Market cap is less than US$100m (kr379.8m market cap, or US$40.0m). Recent Insider Transactions • Sep 25
Key Executive recently bought kr82k worth of stock On the 23rd of September, Peter Benson bought around 23k shares on-market at roughly kr3.55 per share. This transaction amounted to 10% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Peter has been a buyer over the last 12 months, purchasing a net total of kr136k worth in shares. Price Target Changed • Aug 25
Price target increased by 10% to kr7.42 Up from kr6.71, the current price target is an average from 3 analysts. New target price is 59% above last closing price of kr4.68. Stock is up 118% over the past year. The company is forecast to post earnings per share of kr0.09 next year compared to a net loss per share of kr1.48 last year. Breakeven Date Change • Aug 21 The 3 analysts covering Ascelia Pharma previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of kr36.0m in 2025. Earnings growth of 1.3% is required to achieve expected profit on schedule.
New Risk • May 16
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -kr65m This is considered a minor 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 Shareholders have been substantially diluted in the past year (244% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr65m). Market cap is less than US$100m (kr433.4m market cap, or US$44.3m). Price Target Changed • Apr 28
Price target decreased by 13% to kr6.71 Down from kr7.68, the current price target is an average from 4 analysts. New target price is 113% above last closing price of kr3.15. Stock is down 70% over the past year. The company is forecast to post earnings per share of kr0.15 next year compared to a net loss per share of kr1.48 last year. Recent Insider Transactions Derivative • Apr 20
Chief Executive Officer exercised options to buy kr309k worth of stock. On the 15th of April, Magnus Corfitzen exercised options to buy 100k shares at a strike price of around kr2.15, costing a total of kr215k. Since December 2024, Magnus' direct individual holding has increased from 341.75k shares to 441.75k. Company insiders have collectively bought kr394k more than they sold, via options and on-market transactions, in the last 12 months. Breakeven Date Change • Feb 18
Forecast breakeven date moved forward to 2025 The 3 analysts covering Ascelia Pharma previously expected the company to break even in 2027. New consensus forecast suggests the company will make a profit of kr41.0m in 2025. Earnings growth of 67% is required to achieve expected profit on schedule. New Risk • Feb 11
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr80m Forecast net loss in 2 years: kr36m 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 Shareholders have been substantially diluted in the past year (185% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr36m net loss in 2 years). Market cap is less than US$100m (kr291.7m market cap, or US$26.7m). Tillkännagivande • Jan 27
Ascelia Pharma Announces Acceptance of Three Scientific Abstracts with SPARKLE Phase 3 Data at the European Society of Gastrointestinal and Abdominal Radiology Annual Meeting Ascelia Pharma AB (publ) announced that two oral presentations and one scientific poster with clinical data from the SPARKLE Phase 3 study with Orviglance have been accepted for presentation at the European Society of Gastrointestinal and Abdominal Radiology (ESGAR) Annual Meeting, taking place 13-16 May in Amsterdam, Netherlands.
All three abstracts outline data and conclusions from the SPARKLE Phase 3 study with Orviglance. In the study, Orviglance was shown to enhance the detection of suspected or known focal liver lesions, including small-sized lesions, and consistently shows positive results in visualizing lesions in both patients with hepatocellular carcinoma (HCC, primary liver cancer) and those with liver metastases. The study includes patients with severe renal impairment who currently lack an alternative to gadolinium-based contrast MRI.
Ascelia Pharma expects to submit the New Drug Application (NDA) file for Orviglance to the US Food and Drug Administration (FDA) by mid-2025 to obtain regulatory approval. Breakeven Date Change • Jan 01
Forecast to breakeven in 2027 The 2 analysts covering Ascelia Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr70.0m in 2027. Average annual earnings growth of 47% is required to achieve expected profit on schedule. Recent Insider Transactions • Nov 11
Key Executive recently bought kr55k worth of stock On the 8th of November, Peter Benson bought around 20k shares on-market at roughly kr2.73 per share. This transaction amounted to 18% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Peter has been a buyer over the last 12 months, purchasing a net total of kr449k worth in shares. Tillkännagivande • Oct 31
Ascelia Pharma AB (Publ) Announces Appointment of Marianne Kock as New Board Member Ascelia Pharma on 30 October 2024, at an extraordinary general meeting resolved, in accordance with the proposal from the Nomination Committee, to elect Marianne Kock as new board member for the time period up until the end of the next annual general meeting alongside the board members elected at the annual general meeting held on 6 May 2024. Tillkännagivande • Oct 24
Ascelia Pharma AB (Publ) Presents Late-Breaking Abstract on Sparkle Data At the American Society of Nephrology Kidney Week Congress 2024 Ascelia Pharma AB (publ) announced that its latest scientific abstract, titled SPARKLE: A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of ACE-MBCA (Orviglance) in Patients with Known or Suspected Focal Liver Lesions and Severe Renal Impairment, has been accepted as part of the Late-Breaking Science Posters session at the prestigious American Society of Nephrology Kidney Week Congress 2024, taking place from 23-27 October in San Diego, US. The abstract highlights the significant findings from the SPARKLE study on the safety and efficacy of Orviglance and demonstrates that it improves diagnostic efficacy on suspected or known liver lesions (including liver cancer and metastasis) for patients with severe kidney impairment who currently lack alternatives to gadolinium-based contrast enhanced MRI. New Risk • Sep 25
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 185% 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 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 (17% average weekly change). Shareholders have been substantially diluted in the past year (185% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr46m net loss in 2 years). Market cap is less than US$100m (kr236.4m market cap, or US$23.2m). Tillkännagivande • Sep 16
Ascelia Pharma AB (publ), Annual General Meeting, Apr 10, 2025 Ascelia Pharma AB (publ), Annual General Meeting, Apr 10, 2025. New Risk • Aug 16
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: kr86.1m (US$8.17m) This is considered a major risk. Companies with a small market capitalization 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 (-kr104m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (kr86.1m market cap, or US$8.17m). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (kr72m net loss in 2 years). Recent Insider Transactions • May 20
VP of Pharmaceutical Development recently bought kr103k worth of stock On the 17th of May, Carin Linde bought around 12k shares on-market at roughly kr8.76 per share. This transaction amounted to 2.9% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought kr1.3m more in shares than they have sold in the last 12 months. New Risk • May 09
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 31% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. 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 (-kr127m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 31% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr203m net loss in 3 years). Market cap is less than US$100m (kr356.5m market cap, or US$32.7m). Price Target Changed • May 03
Price target increased by 22% to kr9.75 Up from kr8.00, the current price target is an average from 2 analysts. New target price is 17% below last closing price of kr11.76. Stock is down 20% over the past year. The company is forecast to post a net loss per share of kr1.30 next year compared to a net loss per share of kr3.24 last year. New Risk • May 03
New major risk - Revenue and earnings growth Earnings have declined by 23% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. 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 (-kr127m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings have declined by 23% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (kr37m net loss next year). Market cap is less than US$100m (kr416.6m market cap, or US$38.4m). Tillkännagivande • May 03
Ascelia Pharma AB (publ) Successfully Meets Primary Endpoint with Strong Headline Results in Orvigance Phase 3 Study Ascelia Pharma AB (publ) announced that liver imaging drug candidate, Orviglance®?, significantly improved visualization of focal liver lesions, successfully meeting the primary endpoint in the pivotal Phase 3 study SPARKLE. The Phase 3 study demonstrated strong superiority in visualization of focal liver lesions with Orviglance (CMRI) vs. unenhanced MRI with statistical significance for all three readers (<0.001) Orviglance is in development as a first-in-class contrast agent for use in liver MRI in patients with severely impaired kidney function and has been granted FDA Orphan Drug Designation. Orviglance addresses a global USD 800 million market annually. The Phase 3 data marks the completion of Orviglance clinical development with nine studies in 286 patients and healthy volunteers. Submission of the New Drug Application (NDA) file to the US Food and Drug Administration (FDA) is expected by mid-2025. The pivotal Phase 3 study, SPARKLE, successfully met the primary endpoint and demonstrated that the company's magnetic resonance imaging (MRI) contrast agent, Orviglance significantly improved the visualization of focal liver lesions compared to unenhanced MRI. The Company expects to submit the New Drug Application (ND) file to the US Food & Drug Administration (FDA) by mid-2025 to obtain regulatory approval. Clinical development of Orviglance has now been completed with consistent positive efficacy and safety data from 286 patients and healthy volunteers in nine studies, of which the SPARKLE is the last and pivotal study. Patient enrollment in the global multi-center SPARKLE study was completed early 2023, with MRI data from 85 patients with known or suspected focal liver lesions and severely impaired kidney function. In accordance with regulatory requirements, the improvement of visualization of lesions was evaluated by three independent radiologist readers. In mid-2023, the unexpected discovery of high intra- reader variability in the study image scoring by the readers prevented the Company from evaluating the efficacy data from SPARKLE. Therefore, a new evaluation of the images with new readers was required. The company successfully completed the re-evaluation according to the planned timeline with the announcement today. Orviglance has been granted an Orphan Drug Designation by the US Food and Drug Administration ("FDA") for liver MRI in patients with severely impairment kidney function. These patients have the highest risk of developing the serious and potentially fatal condition Nephrogenic Systemic Fibrosis (NSF) after exposure to the currently available class of gadolinium-based contrast agents. These patients are at risk of serious side effects from the currently available class of gadolium-based contrast agents. Orviglance, has been granted an Orphan drug Designation by the US Food & Drug Administration ("FDA"). A clinical program of nine studies, including the pivotal global Phase 3 study SPARKLE, has successfully been completed with strong and consistent efficacy and safety results. Oncoral. Oncoral, the Phase 3 study SPARKLE has successfully been completed with strong & consistent efficacy and safety results. Recent Insider Transactions • Feb 26
Key Executive recently bought kr62k worth of stock On the 23rd of February, Peter Benson bought around 8k shares on-market at roughly kr7.50 per share. This transaction amounted to 8.3% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth kr286k. Peter has been a buyer over the last 12 months, purchasing a net total of kr395k worth in shares. Price Target Changed • Feb 01
Price target decreased by 61% to kr8.00 Down from kr20.50, the current price target is provided by 1 analyst. New target price is 11% below last closing price of kr8.97. Stock is down 38% over the past year. The company posted a net loss per share of kr3.77 last year. New Risk • Feb 01
New major risk - Revenue and earnings growth Earnings have declined by 28% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. 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 (-kr140m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings have declined by 28% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr280.9m market cap, or US$26.8m). Recent Insider Transactions • Jan 10
Deputy CEO & Chief Commercial Officer recently bought kr170k worth of stock On the 8th of January, Julie Brogren bought around 30k shares on-market at roughly kr5.65 per share. This transaction amounted to 42% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought kr1.3m more in shares than they have sold in the last 12 months. Price Target Changed • Nov 10
Price target decreased by 7.1% to kr19.50 Down from kr21.00, the current price target is an average from 2 analysts. New target price is 595% above last closing price of kr2.81. Stock is down 88% over the past year. The company is forecast to post a net loss per share of kr3.68 next year compared to a net loss per share of kr3.77 last year. Tillkännagivande • Aug 10
Ascelia Pharma AB (publ) Announces Re-Evaluation Required After Intra-Reader Inconsistency in Scoring of Images from Phase 3 Study SPARKLE Ascelia Pharma AB (publ) reported the need for a re-evaluation of the collected images in the pivotal Phase 3 study SPARKLE with the liver imaging candidate drug Orviglance®. As per FDA guidance, a pre-defined number of patients were evaluated twice. This showed a high level of variability in the evaluation of images by some readers, which necessitates a re-evaluation of all images by a new group of independent radiology readers. Ascelia Pharma completed the global multi-center SPARKLE study in early March 2023 with MRI data from 85 completed patients. Since then, the MRI images have been read and evaluated by three independent radiologists as required by regulatory standards. During the evaluation of headline data, the company identified a high level of inconsistency in the image scoring by some individual readers, i.e., intra-reader variability. Intra-reader variability occurs when a reader reports different scores for the same image when seen at a different time point. This finding means that data from SPARKLE cannot be reported based on the performed reading. The patient recruitment and collection and transfer of MR images to the central database has been correctly performed and the company does not see a need for a new clinical study. Common adverse events in the SPARKLE study were in line with previous studies with Orviglance, such as mild to moderate nausea. No drug related serious adverse reactions were reported. New Risk • Aug 09
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Swedish stocks, typically moving 21% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. 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 (-kr131m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Earnings are forecast to decline by an average of 25% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr285m net loss in 2 years). Market cap is less than US$100m (kr161.2m market cap, or US$15.1m). Recent Insider Transactions • Jul 16
Chief Scientific Officer recently bought kr86k worth of stock On the 13th of July, Andreas Norlin bought around 6k shares on-market at roughly kr14.50 per share. This transaction amounted to 92% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger purchase from another insider worth kr109k. Insiders have collectively bought kr1.5m more in shares than they have sold in the last 12 months. New Risk • Jul 05
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 25% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. 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 (-kr131m free cash flow). Earnings are forecast to decline by an average of 25% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr285m net loss in 2 years). Market cap is less than US$100m (kr483.6m market cap, or US$44.7m). Board Change • Jun 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. 4 experienced directors. 1 highly experienced director. Independent Director Lauren Barnes was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Recent Insider Transactions • Feb 22
Independent Director recently bought kr352k worth of stock On the 17th of February, Niels Mengel bought around 22k shares on-market at roughly kr15.66 per share. This transaction amounted to 8.3% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought kr1.9m more in shares than they have sold in the last 12 months. Tillkännagivande • Jan 28
Ascelia Pharma AB (publ) Announces 71 Patients Have Completed the SPARKLE Study Ascelia Pharma AB (publ) announced that by January 27, 2023, 71 patients have completed the pivotal Phase 3 clinical SPARKLE study with the lead candidate drug Orviglance. On December 29, 2022, Ascelia Pharma announced that 65 patients had completed the SPARKLE study, which will include 80 patients in total. Since that announcement, 6 more patients have completed the study. The company expects to complete patient enrollment by February/March 2023 with topline results by mid-2023. The SPARKLE study is the third and last of three clinical studies that form the Phase 3 programfor Orviglance, the company's orphan liver imaging agent. Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imagingdeveloped to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is currently in Phase 3 development, including the global multi-center SPARKLE study. Oncoral is a novel irinotecan chemotherapy tablet developed initially for the treatment of gastric cancer. Irinotecan chemotherapy has an established potent anti-tumor effect. Oncoral is a daily tablet with the potential to offer better patient outcomes with improved safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital. Following successful Phase 1 results, Oncoral is now prepared for Phase 2 clinical development. Price Target Changed • Dec 13
Price target decreased to kr48.00 Down from kr61.50, the current price target is an average from 2 analysts. New target price is 217% above last closing price of kr15.14. Stock is down 49% over the past year. The company is forecast to post a net loss per share of kr3.73 next year compared to a net loss per share of kr3.82 last year. Recent Insider Transactions • Dec 08
Key Executive recently bought kr225k worth of stock On the 6th of December, Peter Benson bought around 13k shares on-market at roughly kr17.32 per share. This transaction amounted to 59% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Peter has been a buyer over the last 12 months, purchasing a net total of kr738k worth in shares. Price Target Changed • Dec 06
Price target decreased to kr59.00 Down from kr64.00, the current price target is an average from 2 analysts. New target price is 243% above last closing price of kr17.20. Stock is down 46% over the past year. The company is forecast to post a net loss per share of kr3.73 next year compared to a net loss per share of kr3.82 last year. Recent Insider Transactions • Jun 07
Chief Commercial Officer recently bought kr310k worth of stock On the 3rd of June, Julie Brogren bought around 15k shares on-market at roughly kr20.64 per share. In the last 3 months, there was an even bigger purchase from another insider worth kr459k. Insiders have collectively bought kr2.1m more in shares than they have sold in the last 12 months. Recent Insider Transactions • May 31
Key Executive recently bought kr101k worth of stock On the 25th of May, Peter Benson bought around 5k shares on-market at roughly kr20.30 per share. In the last 3 months, there was an even bigger purchase from another insider worth kr459k. Peter has been a buyer over the last 12 months, purchasing a net total of kr473k worth in shares. Recent Insider Transactions • May 20
Chief Executive Officer recently bought kr459k worth of stock On the 16th of May, Magnus Corfitzen bought around 23k shares on-market at roughly kr20.38 per share. This was the largest purchase by an insider in the last 3 months. Magnus has been a buyer over the last 12 months, purchasing a net total of kr837k worth in shares. Tillkännagivande • May 12
Ascelia Pharma's Food Effect Study Shows Orviglance Image Enhancement of the Liver Is Not Reduced by Light Meal Ascelia Pharma AB (publ) announced the results of the Food Effect Study that evaluated the effect of food intake on absorption and signal intensity of Orviglance®. The results showed that intake of a light meal prior to Orviglance administration provides similar image MRI enhancement of the liver compared to a fasting condition. In line with previous studies, the data also confirmed robust image enhancement of the liver after Orviglance administration compared to an MRI image without a contrast agent. A patent application has been filed on these new findings. In this crossover study, Orviglance was administered to 24 healthy volunteers in fasting condition and in one of two conditions with food intake (either light meal or full meal). The image enhancement effect was measured as the change in the MR signal intensity before and after (1, 4, 8 and 24 hours) administration of Orviglance. The results showed that a light meal prior to Orviglance administration provided similar image enhancement when compared to a fasting condition, whereas the image enhancement was less pronounced for the group receiving a full meal. The strongest signal intensity occurred 4 hours after administration, which is in line with what has been observed in previous studies. The Food Effect Study forms part of Orviglance ongoing pivotal clinical program and the results will be included in the marketing authorization submission package to the health authorities including FDA and EMA. Ascelia Pharma has filed a patent application based on the results of the study. Price Target Changed • Apr 27
Price target increased to kr64.00 Up from kr46.00, the current price target is an average from 2 analysts. New target price is 200% above last closing price of kr21.35. Stock is down 43% over the past year. The company is forecast to post a net loss per share of kr4.57 next year compared to a net loss per share of kr3.82 last year. Board Change • Apr 27
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 2 highly experienced directors. Independent Director Lauren Barnes was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Tillkännagivande • Mar 10
Ascelia Pharma Suspends Clinical Activities in Russia Ascelia Pharma AB announced that due to the Russian invasion of Ukraine, all clinical activities in Russia in the ongoing Phase 3 study SPARKLE are being suspended. As a consequence, the expected recruitment completion for the SPARKLE study is extended to 2022 (previously H1 2022). The consequences of Russia’s invasion of Ukraine are both grave and concerning. Because of the escalating situation, Ascelia Pharma has decided to suspend all clinical activities, including patient enrolment, in Russia. We are mindful of the patients and the Russian medical staff with whom we have worked with. Ascelia Pharma is committed to completing the SPARKLE study as fast as possible. We are working with the already active study hospitals to accelerate enrolment as well as expanding the number of participating hospitals. Among the 47 clinical sites currently open in the SPARKLE study globally, 13 are located in Russia. The decision to suspend clinical activities in Russia may extend the timeline for completing patient recruitment in the study. The expected recruitment completion is therefore extended to 2022 (previously H1 2022). As previously communicated, Ascelia Pharma has sufficient financing to complete the SPARKLE study. Recent Insider Transactions • Feb 15
Key Executive recently bought kr116k worth of stock On the 10th of February, Peter Benson bought around 4k shares on-market at roughly kr25.92 per share. This was the largest purchase by an insider in the last 3 months. This was Peter's only on-market trade for the last 12 months. Tillkännagivande • Dec 17
Ascelia Pharma AB (publ) Receives FDA Acceptance of IND Application for Oncoral Clinical Trial Ascelia Pharma AB (publ) announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for the upcoming global Phase 2 clinical study in gastric cancer with the daily oral chemotherapy candidate drug Oncoral. In this combination study, Ascelia Pharma's irinotecan chemotherapy tablet Oncoral (ASC-201) will be evaluated in combination with Taiho Oncology's LONSURF® (trifluridine and tipiracil) film-coated tablets for oral use. The all-oral combination of Oncoral and LONSURF is investigational at this time and not approved for use in gastric cancer or any other disease. Following an initial dose-finding part, the Phase 2 study will be a randomized controlled multicenter study of Oncoral added to LONSURF compared to LONSURF alone. The primary endpoint will be progression-free survival, with secondary endpoints including response rate, overall survival, pharmacokinetics, safety, and tolerability. The study will include approximately 100 patients with metastatic gastric cancer and first patient visit is planned for first half of 2022. The initial portion of the planned global study will be conducted at hospitals in Europe, whereas the subsequent randomized part will also include US sites. Tillkännagivande • Dec 03
Ascelia Pharma AB (publ) Announces Results from Orviglance comparison study to gadolinium presented at RSNA 2021 Ascelia Pharma AB (publ) presented results at the radiology conference, RSNA, in Chicago, Illinois from the study in which the investigational contrast agent Orviglance® was compared against a gadolinium-based contrast agent. As communicated earlier, the comparison study versus the gadolinium contrast agent showed that MRI enhanced with the contrast agent Orviglance (former working name Mangoral) was as effective as the gadolinium contrast agent gadobenate dimeglumine (Multihance) in terms of visualization of lesions and number of detected lesions in the liver. The results also showed that Orviglance-enhanced MRI provides improved efficacy in terms of lesion detection and visualization compared to MRI without a contrast agent. The presentation at RSNA shows specifically the results of the efficacy parameters in the study including: Number of lesions detected; Size of the detected lesions; Lesion border delineation; Lesion contrast compared to liver. The results showed that a higher number of liver lesions was detected by all three independent readers for Orviglance compared to gadolinium. All three readers were also able to see smaller lesions with Orviglance compared to gadolinium. With respect to lesion border delineation and lesion contrast to liver, two out of three readers reported higher scores to Orviglance compared to gadolinium. While the efficacy parameters show higher scores for Orviglance, it is important to notice that this crossover study was comprised only of 20 patients with liver metastases and the higher scores for Orviglance vs. gadolinium are not statistically sufficient to conclude that Orviglance is superior to gadolinium. Recent Insider Transactions • Sep 18
Chief Commercial Officer recently bought kr208k worth of stock On the 17th of September, Julie Brogren bought around 7k shares on-market at roughly kr29.75 per share. In the last 3 months, there was an even bigger purchase from another insider worth kr379k. Despite this recent purchase, insiders have collectively sold kr4.0m more in shares than they bought in the last 12 months. Recent Insider Transactions • Sep 01
Chief Medical Officer recently bought kr260k worth of stock On the 30th of August, Carl Bjartmar bought around 9k shares on-market at roughly kr27.64 per share. In the last 3 months, there was an even bigger purchase from another insider worth kr379k. Despite this recent purchase, insiders have collectively sold kr3.9m more in shares than they bought in the last 12 months. Tillkännagivande • Aug 14
Ascelia Pharma AB (publ) Announces Abstract for Orviglance Comparison Study to Gadolinium Accepted At the Radiology Conference RSNA Ascelia Pharma AB (publ) announced that the study where Orviglance® (manganese chloride tetrahydrate, former working name Mangoral) was compared against a gadolinium-based specific contrast agent has been accepted as an oral paper presentation at the radiology conference RSNA. The conference will be held November 28 - December 3 in Chicago, Illinois. In December 2020, Ascelia Pharma announced the results of a comparison study versus a gadolinium contrast agent. The results showed that Orviglance enhanced MRI was as effective as the gadolinium contrast agent gadobenate dimeglumine (Multihance) in terms of visualization of lesions and number of detected lesions detection. In fact, 2 out of the 3 independent readers reported higher scores for Orviglance enhanced MRI. The results also showed that Orviglance enhanced MRI provides improved diagnostic efficacy compared to MRI without a contrast agent using identical endpoints as in the ongoing pivotal Phase 3 study SPARKLE. Tillkännagivande • Aug 11
Ascelia Pharma AB (publ) Receives Conditional U.S. Food and Drug Administration Acceptance for Orviglance Ascelia Pharma AB (publ) announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted Orviglance® as the proposed brand name for manganese chloride tetrahydrate (Mangoral), the company's novel first-in-class MRI contrast agent for use in liver MR imaging in adults with severely impaired kidney function. The name Orviglance was developed in accordance with FDA's guidance for the submission and evaluation of proprietary names and the name selection included a research study of healthcare practitioners across the U.S. to ensure accurate prescription and safety interpretation of the name. In addition, Orviglance previously received an invented name approval from the European Medicines Agency (EMA). Orviglance (previously referred to as Mangoral), which entered pivotal clinical studies in 2020, has been granted an Orphan Drug Designation (ODD) by the FDA and is targeted patients with poor kidney function who undergo an MRI scan of the liver to detect cancer. As part of the launch plans for Orviglance, Ascelia Pharma opened its US office in New Jersey earlier this year. Recent Insider Transactions • Jul 16
Chief Executive Officer recently bought kr379k worth of stock On the 13th of July, Magnus Corfitzen bought around 10k shares on-market at roughly kr37.86 per share. This was the largest purchase by an insider in the last 3 months. Despite this recent buy, Magnus has been a net seller over the last 12 months, reducing personal holdings by kr5.1m. Recent Insider Transactions • Mar 19
Chief Executive Officer recently sold kr5.8m worth of stock On the 18th of March, Magnus Corfitzen sold around 145k shares on-market at roughly kr40.00 per share. This was the largest sale by an insider in the last 3 months. Magnus has been a seller over the last 12 months, reducing personal holdings by kr5.5m. Recent Insider Transactions Derivative • Mar 19
Chief Executive Officer exercised options to buy kr11m worth of stock. On the 17th of March, Magnus Corfitzen exercised options to buy 275k shares at a strike price of around kr8.00, costing a total of kr2.2m. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. Since June 2020, Magnus' direct individual holding has increased from 51.68k shares to 112.63k. Company insiders have collectively sold kr1.7m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions • Feb 19
Chief Medical Officer recently bought kr392k worth of stock On the 17th of February, Carl Bjartmar bought around 9k shares on-market at roughly kr43.50 per share. In the last 3 months, there was an even bigger purchase from another insider worth kr469k. Insiders have collectively bought kr1.9m more in shares than they have sold in the last 12 months. Tillkännagivande • Jan 12
Ascelia Pharma AB (publ) Presents Clinical Development Plan for Oncoral as a Novel Chemotherapy Ascelia Pharma AB (publ) announced the clinical development plan for Oncoral. With Oncoral, Ascelia Pharma has the opportunity to develop a novel oral chemotherapy with the potential to offer both efficacy and safety benefits to cancer patients. The planned Phase 2 study, for the treatment of gastric cancer, is expected to start in second half of 2021. Development plan - Phase 2 in gastric cancer: With encouraging Phase 1 data, Ascelia Pharma has prepared the next steps of clinical development. The planned Phase 2 study, which is expected to commence in second half of 2021, will address metastatic gastric cancer, which is a serious disease with large unmet medical need for novel safe and effective therapies. The clinical guidelines and clinical data support efficacy of the active substance in Oncoral - irinotecan - in patients with gastric cancer. In gastric cancer, there is also an opportunity to obtain Orphan Drug Designation in the US and the EU. The Phase 2 study will be a randomized controlled multicenter study of Oncoral added to Standard of Care, compared to Standard of Care alone. The primary endpoint will be progression-free survival, which is standard for an oncology Phase 2 study. Secondary endpoints will include response rate, overall survival, pharmacokinetics, safety, and tolerability. For subsequent development, there is potential for label expansion into other solid tumor indications where irinotecan has also proved efficacious. The development of Oncoral is supported by a Scientific Advisory Board of leading oncologists, who all share the company's view that Oncoral, a daily tablet formulation of irinotecan, would be a valuable additional treatment option for cancer patients, especially in later disease stages. Oncoral - based on the well-established chemotherapy irinotecan: The active substance in Oncoral is irinotecan. Irinotecan is a well-established chemotherapy with documented anti-cancer effects. It is approved for treating colorectal and pancreatic cancer as well as for gastric cancer in Japan. The administration of irinotecan is intravenous (IV) bolus infusions, typically as a high dose every third week. Oncoral is a novel patented tablet formulation of irinotecan for daily dosing at home with potential to offer better patient outcomes. Oncoral - potential to improve both efficacy and safety: Intravenous chemotherapy is often a trade-off between desired treatment effect and tolerability for the patient. With Oncoral as a daily irinotecan tablet there is a potential to improve both efficacy and tolerability compared to IV administration. In addition, it may offer convenience for the patient and at the same time reduce hospital costs with home administration. The potential to improve efficacy is based on a fivefold higher conversion rate of irinotecan to the cytotoxic active metabolite SN-38 when dosed orally compared to an IV infusion. In addition, the principle of frequent, low daily dosing, also called metronomic dosing, may optimize the exposure of SN-38 and thus maximize the anti-tumor effect. Several non-clinical and clinical studies provide proof of concept for metronomic dosing, including improved patient outcomes. In the Phase 1 study with Oncoral, clinical benefits with stable disease were observed even in patients that previously received IV irinotecan. Conventional IV bolus administration of irinotecan is associated with toxicity. Most patients experience gastrointestinal and hematological side effects, of which approximately 30% are severe or life-threatening (grade 3 or 4, ref: Camptosar® prescribing information). Frequent low dosing, avoiding high peak plasma levels, may reduce toxicity and complications compared to high-dose IV infusions. Oral daily administration also brings the opportunity to adjust dosing quickly in case of acute toxicity. In the Phase 1 study, Oncoral was well tolerated and the hematological toxicities were only mild to moderate, grade 1 or grade 2. Tillkännagivande • Dec 16
Ascelia Pharma Gets US Patent for Second Generation Mangoral Ascelia Pharma AB announced that the US Patent Office (USPTO) has issued a new patent covering a second-generation formulation of lead drug candidate Mangoral, currently in the pivotal Phase 3 study SPARKLE. The new patent further improves the unique value proposition of the Mangoral franchise and provides patent protection until year 2040 in the US. Recent Insider Transactions • Dec 09
Independent Director recently bought kr469k worth of stock On the 4th of December, Helena Wennerström bought around 10k shares on-market at roughly kr46.93 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought kr1.5m more in shares than they have sold in the last 12 months. Tillkännagivande • Dec 03
Ascelia Pharma AB (Publ) Announces New Study Shows Mangoral's Lesion Visualization as Effective as Gadolinium Contrast Agent Ascelia Pharma AB (publ) announced the results from an independent reader study where Mangoral was compared against a gadolinium-based liver specific contrast agent. The
results showed that Mangoral was as effective as the gadolinium-based contrast agent gadobenate dimeglumine for visualization of focal liver lesions. The results also showed that Mangoral-enhanced MRI provides improved diagnostic efficacy compared to MRI without a contrast agent using identical endpoints as in Ascelia Pharma's ongoing pivotal Phase 3 study SPARKLE.
The blinded re-read study was performed on the images from a previously conducted clinical trial at Karolinska University Hospital in Stockholm, Sweden. The study included 20 patients with colorectal cancer and suspected liver metastases who underwent both Mangoral- and gadolinium-based enhanced liver MRI in a cross-over design with each patient as their own control. The purpose of the re-read study was to apply the assessment methodology recommended by regulatory guidelines for contrast agent development. The endpoints and evaluation criteria in the re-read study were therefore the same as in the current ongoing SPARKLE study. In the re-read study, the liver MRI scans were assessed by three independent radiologists who were
blinded to the drug and other clinical information, whereas the original data was assessed by a single on-site radiologist. The results show that Mangoral enhanced MRI has similar efficacy compared to the liver contrast agent gadobenate dimeglumine (Multihance) in terms of visualization of lesions and number of detected lesions detection with 2 out of 3 readers reporting higher scores for Mangoral enhanced MRI. The second part of the re-read study was to evaluate the diagnostic efficacy of Mangoral-enhanced liver MRI compared to unenhanced liver MRI (i e liver MRI without a contrast agent). In this comparison all three readers concluded that Mangoral provided improved lesion detection and lesion visualization compared to unenhanced liver MRI. 
