Anuncio • May 22
Bioporto A/S Un-changes Earnings Guidance for the Full Year 2026 BioPorto A/S unchanged earnings guidance for the full year 2026. For the full year 2026, Guidance for 2026 remains unchanged as announced April 8, 2026. The Company therefore expects total revenue of DKK 38 million to DKK 48 million, total NGAL revenue of DKK 33 million to DKK 42 million. Board Change • May 21
High number of new and inexperienced directors There are 4 new directors who have joined the board in the last 3 years. The company's board is composed of: 4 new directors. No experienced directors. No highly experienced directors. Independent Vice-Chairman of the Board Henrik Juuel is the most experienced director on the board, commencing their role in 2024. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model. Anuncio • Apr 02
Bioporto A/S Advances U.S. Adult Urine Ngal Program with Fda Pre-Submission Request BioPorto A/S had formally submitted its FDA pre-submission package to the U.S. Food and Drug Administration (FDA). This marks an important regulatory milestone for the Company and follows the positive preliminary analysis recently completed for the U.S. adult urine NGAL Cut-off Study. On 18 March 2026, BioPorto reported that the preliminary analysis demonstrated results supporting the study’s primary endpoint, providing the foundation for the next phase of the Company’s regulatory strategy. Building on these findings, BioPorto has now submitted its FDA pre-submission package, seeking Agency feedback on the proposed clinical study design for the upcoming Validation Study, which is an essential step toward U.S. regulatory 510(k) clearance. With the pre-submission meeting package now filed, BioPorto seeks FDA feedback to align with the Agency on the Validation Study protocol. This announcement does not alter BioPorto’s financial guidance as recently published on 5 February 2026. Anuncio • Mar 27
BioPorto A/S, Annual General Meeting, Apr 24, 2026 BioPorto A/S, Annual General Meeting, Apr 24, 2026, at 15:00 Romance Standard Time. Location: tuborg havnevej 15, st., dk-2900 hellerup, Denmark Anuncio • Mar 20
BioPorto A S Successfully Completes Preliminary Analysis of U S Adult NGAL Cutoff Study BioPorto A/S announced positive clinical readout update of the preliminary analysis of its U.S. adult NGAL Cutoff Study, designed to evaluate the clinical performance of NGAL in assessing risk of acute kidney injury (AKI). The Company intends to submit its FDA Pre-submission package by the end of March 2026, to ensure robustness in its subsequent Validation Study. Patient enrollment was completed in October 2025, and database lock was finalized in March 2026. The preliminary analysis of the adult study has shown positive results supporting the study’s primary endpoint, consistent with the findings from the Company’s cutoff and validation study conducted in the pediatric segment, which subsequently led to FDA clearance at the end of 2023 for the pediatric indication. This is providing a strong foundation for BioPorto’s regulatory strategy going forward. The planned Pre-submission will seek FDA’s feedback on the regulatory pathway as well as the design of analytical and clinical study protocols for the Validation Study. Subsequently, the Validation Study will be initiated. This announcement does not alter BioPorto’s financial guidance as recently published on 5 February 2026. Anuncio • Feb 06
BioPorto A/S Provides Its Earnings Guidance for Full Year 2026 BioPorto A/S provided its earnings guidance for full year 2026. For the year, the company For 2026, the total NGAL revenue is expected in range of DKK 48 Million to DKK 58 million. Anuncio • Dec 13
BioPorto A/S Announces Resignation of CFO Niels Høy Nielsen BioPorto A/S announced that Niels Høy Nielsen has resigned as Chief Financial Officer of BioPorto to become CFO at another company. Niels Høy Nielsen will continue to serve in his current role at the Company through March 2026. Anuncio • Nov 20
BioPorto A/S Confirms Earnings Guidance for Full Year 2025 BioPorto A/S confirmed its earnings guidance for full year 2025. For the year, the company total revenue expectation is to be in the range of DKK 40 million - DKK 45 million. Anuncio • Jun 30
Bioporto A/S Announces Initiation of Commercialization of Pronephro Aki (Ngal) for Diagnostic Use in the Us BioPorto A/S announced the initiation of commercialization in the US of ProNephro AKITM (NGAL) for clinical use in risk stratification for moderate-to-severe AKI for patients aged 3 months to 21 years, by receiving the first purchase order of ProNephro AK ITM (NGAL) for the US market. This purchase order is to service US hospitals through BioPorto's distribution relationship with Roche Diagnostics. Currently, ProNephro AKI TM (NGAL) has FDA 510(k) marketing clearance for Roche's cobas®? c501 analyzers, that are broadly available in standard medical laboratories and hospitals. Anuncio • Apr 15
BioPorto A/S has completed a Follow-on Equity Offering in the amount of DKK 33.505 million. BioPorto A/S has completed a Follow-on Equity Offering in the amount of DKK 33.505 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 25,000,000
Price\Range: DKK 1.3402
Transaction Features: Subsequent Direct Listing Anuncio • Apr 14
BioPorto A/S has filed a Follow-on Equity Offering in the amount of DKK 33.505 million. BioPorto A/S has filed a Follow-on Equity Offering in the amount of DKK 33.505 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 25,000,000
Price\Range: DKK 1.3402
Transaction Features: Subsequent Direct Listing Anuncio • Apr 12
BioPorto A/S Approves Board Appointments BioPorto A/S held its Annual General on April 11, 2025, elected Jens Due Olsen and Donna Haire as new members of the Board of Directors. After the Annual General Meeting, the Board of Directors constituted itself by electing Jens Due Olsen as Chair and Henrik Juuel as Vice Chair of the Board of Directors. Anuncio • Mar 20
BioPorto Provides Earnings Guidance for the Fiscal Year 2025 and Aspirations for 2026 Towards 2029 BioPorto A/S provided earnings guidance for the fiscal year 2025. For the year, the company is targeting total revenue of DKK 45 million to DKK 60 million, corresponding to a growth in the range of 24 % to 66% compared to 2024. Growth will be driven by increased ProNehro AKI (NGAL) sales, especially in the US. Revenue in 2025 is expected to be back-end loaded.
For the 2026, the company aspired to reach total revenue of DKK 80 million to DKK 125 million (app. USD 12 million to USD 18 million). BioPorto’s aspiration to reach and exceed DKK 700 million (app. USD 100 million) in total revenue by 2029. Anuncio • Mar 06
BioPorto A/S, Annual General Meeting, Apr 11, 2025 BioPorto A/S, Annual General Meeting, Apr 11, 2025. Anuncio • Mar 05
Bioporto A/S Announces Ninfa Saunders, Michael S. Singer and Don M. Hardison Will Not Seek Re-Election BioPorto A/S announced that Ninfa Saunders, Michael S. Singer and Don M. Hardison will not seek re-election at the General Meeting. Anuncio • Feb 28
BioPorto A/S Appoints Hanne Søgaard as Head of Investor Relations, Effective 1 March 2025 BioPorto A/S announced that, effective 1 March 2025, Hanne Søgaard will join BioPorto as the Company's new Head of Investor Relations. Hanne brings extensive experience within Investor Relations and financial communication, having previously led Nykredit's Investor Relations and ESG initiatives. With a strong background in financial analysis and communication from her roles at Nykredit, Juristernes og Økonomernes Pensionskasse, Danske Markets, Skandia Pension, and Alm. Brand Forsikring, Hanne is well-suited to enhance Investor Relations efforts communicating and engaging with investors on strategy and helping drive strategic goals forward. Anuncio • Jan 30
BioPorto A/S Announces Board Changes BioPorto A/S announced that Board Member Henrik Juuel will be appointed interim Chairman of the Board of Directors in BioPorto A/S as John McDonough steps down and resigns as Chair and member of the Board of Directors at the end of this month. Henrik Juuel joined the Board of Directors of BioPorto A/S in 2024 and has more than 30 years of experience from the Life Science industry. Henrik is EVP & CFO of Bavarian Nordic A/S since 2018. Until the Annual General Meeting on April 11, 2025, focus will be on assessing the necessary composition of the Board to address the needs of the Company during its initiation of commercialization and indication expansion phase. As announced on December 16, 2024, the Board is seeking a new Chair to be elected at the Company’s Annual General Meeting in April 2025, which can support the Company’s engagement with investors and stakeholders in the local market and contribute to the Company’s growth. Anuncio • Jan 23
BioPorto A/S Announces the Publication of Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL)Reference Intervals in Healthy Adult and Pediatric Individuals BioPorto A/S announced their publication of reference intervals using BioPorto's NGAL immunoassay in healthy adult and pediatric individuals. The study was published in Diagnostics, an international, open-access, peer-reviewed journal and provides clinicians with a standardized comparison to evaluate NGAL levels ensuring broad clinical applicability in their patients. The publication of the reference range study results will be used by laboratories implementing NGAL assays from BioPorto as a baseline of healthy patient populations, a required step for laboratories to implement clinical tests. These findings address the critical gaps in kidney injury management and ultimately can help with earlier identification of AKI with the use of biomarkers. This BioPorto study is the largest comprehensive study to date of 629 patients with ages ranging from three months to older than 65 years. Anuncio • Nov 14
Bioporto A/S Maintains Revenue Guidance for the Year 2024 BioPorto A/S maintained revenue guidance for the year 2024. Based on the progress and results obtained in the first nine months of 2024 the company maintains Total Revenue target of DKK 40 million. Anuncio • Oct 29
BioPorto A/S Initiates Patient Enrollment for US Study of ProNephro AKI (NGAL) for Adult Use at Massachusetts General Hospital BioPorto A/S announced the enrollment of the first patient in its US clinical study for ProNephro AKI (NGAL) with the goal of determining a cut-off point for risk stratification of moderate to severe of AKI in adult patients. BioPorto's ProNephro AKI (NGAL), currently cleared by the US Food and Drug Administration (FDA) for those 3 months through 21 years of age, has been widely recognized for its groundbreaking potential in refining AKI diagnosis. NGAL is a direct real-time marker of kidney cell damage and can potentially detect AKI days earlier than previously possible. Early detection of AKI may enable prompt intervention to save lives. BioPorto's proprietary assay is a kidney injury marker versus the traditionally used serum creatinine (SCr) functional test. The cut-off study is the first of two studies which will form a substantial part of the submission for US clearance of ProNephro AKI (NGAL) in adult patients. The cut-off study seeks to enroll patients at up to 12 US sites in 2024 and 2025. After having established the cut-off, BioPorto expects to commence enrollment for the second study, the validation study, enabling the Company to submit its FDA application for adult usage of ProNephro AKI (NGAL) by 2026. Reported Earnings • Aug 16
Second quarter 2024 earnings released: kr.0.04 loss per share (vs kr.0.058 loss in 2Q 2023) Second quarter 2024 results: kr.0.04 loss per share (improved from kr.0.058 loss in 2Q 2023). Revenue: kr.9.20m (up 19% from 2Q 2023). Net loss: kr.15.8m (loss narrowed 19% from 2Q 2023). Over the last 3 years on average, earnings per share has increased by 14% per year but the company’s share price has fallen by 6% per year, which means it is significantly lagging earnings. Anuncio • Aug 15
Bioporto A/S Affirms Earnings Guidance for 2024 BioPorto A/S affirmed earnings guidance for 2024. For the period, the company expects total revenue target of DKK 40 million. New Risk • Jun 25
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 13% 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 Risks Less than 1 year of cash runway based on free cash flow trend (-kr.50m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings have declined by 3.1% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (13% increase in shares outstanding). Revenue is less than US$5m (kr.32m revenue, or US$4.7m). Anuncio • May 09
Bioporto A/S Provides Revenue Guidance for 2024 BioPorto A/S provided revenue guidance for 2024. For the period, the company expects total revenue target of DKK 40 million. Reported Earnings • May 08
First quarter 2024 earnings released: kr.0.04 loss per share (vs kr.0.048 loss in 1Q 2023) First quarter 2024 results: kr.0.04 loss per share (improved from kr.0.048 loss in 1Q 2023). Revenue: kr.9.46m (up 18% from 1Q 2023). Net loss: kr.13.6m (loss narrowed 16% from 1Q 2023). 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 30% per year, which means it is significantly lagging earnings. Anuncio • Apr 10
Bioporto A/S Appoints Gry Louise Husby Larsen as Chief Legal Officer and Member of the Executive Management Team, Effective as of April 15, 2024 BioPorto A/S announced the appointment of Gry Louise Husby Larsen as its new Executive Vice President and Chief Legal Officer (CLO), and member of the Executive Management team as of April 15, 2024. Gry Louise Husby Larsen has been employed as General Counsel at BioPorto from 2011 leading the Company’s corporate legal activities within compliance, fundraising, IPR, contracts, HR and ESG ect. In the period from 2019 to 2024, Gry Louise Husby Larsen acted as external General Counsel for BioPorto while also serving as part time General Counsel for FluoGuide A/S, Algiecel A/S and Unibio A/S. Gry Louise Husby Larsen holds a Master of Law from University of Copenhagen and was an Attorney-at-law at Knop & Co. Law Firm until 2011. To further strengthen the leadership of BioPorto, the company expects to announce the appointment of a US CEO for BioPorto’s subsidiary BioPorto Inc. and a group CFO later this quarter. Anuncio • Apr 05
Bioporto A/S Announces Tonni Bülow-Nielsennot to Stand for Election BioPorto A/S announced that it has received notice that Tonni Bülow-Nielsen, due to personal reasons, will not be a candidate for the upcoming general meeting on 30 April 2024. Reported Earnings • Apr 04
Full year 2023 earnings released: kr.0.16 loss per share (vs kr.0.24 loss in FY 2022) Full year 2023 results: kr.0.16 loss per share (improved from kr.0.24 loss in FY 2022). Revenue: kr.31.0m (up 6.9% from FY 2022). Net loss: kr.56.3m (loss narrowed 26% from FY 2022). Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 39% per year, which means it is significantly lagging earnings. Anuncio • Jan 10
BioPorto A/S Announces CEO Changes BioPorto A/S announced changes to the Executive Management. By mutual agreement, BioPorto’s CEO, Anthony Pare, is stepping down and leaving BioPorto with effect from January 9, 2024. Peter Mørch Eriksen has been appointed as interim CEO. The Board of Directors has as of January 9, 2024 appointed Board Member Peter Mørch Eriksen as interim CEO of the Company. Peter Mørch Eriksen will remain in his position as Board Member at least until the expiry of his election period at this year’s Annual General Meeting. Peter Mørch Eriksen has spent more than 25 years in the MedTech/life science industries, including as CEO of Sense A/S and VP of Medtronic. Peter has previously been the CEO of BioPorto in the period from 2013 – 2021 and has served as a Board Member in BioPorto since then. Further, Peter is the Chairman of FluoGuide A/S and MONSENSO A/S. Together with the Board of Directors and the BioPorto team, Peter will finalize work that has already been commenced on the Company’s plans for commercialization, FDA instrument- & indication expansion, financial guidance for 2024 and capital requirements which is to be published by mid-February 2024. Anuncio • Dec 16
BioPorto A/S, Annual General Meeting, Apr 30, 2024 BioPorto A/S, Annual General Meeting, Apr 30, 2024. Anuncio • Dec 08
BioPorto A/S Receives FDA 510(k) Clearance for NGAL Test in the United States BioPorto A/S announced receipt of a US Food and Drug Administration (FDA) 510(k) clearance for BioPorto’s NGAL test, to be marketed as ProNephro AKITM (NGAL). ProNephro AKI (NGAL) is the first Acute Kidney Injury (AKI) biomarker test cleared for pediatric use (aged 3 months through 21 years) in the US. ProNephro AKI (NGAL) is designed to help doctors identify patients at risk of developing or having persistent, moderate-to-severe AKI within 48-72 hours in the intensive care unit (ICU) setting. Unlike serum creatinine, a muscle by-product that is the current standard of care but slow to rise in AKI, NGAL is a direct real time marker of kidney cell damage and can potentially detect AKI days earlier than serum creatinine. Early detection of AKI may enable prompt intervention to save lives. Until now, the risk for developing or having persistent AKI has been difficult to assess early because current standard-of-care methods, such as sCr, rise slowly in AKI. As such, ProNephro AKI (NGAL) was developed to help save kidneys and lives through faster and more timely intervention. Anuncio • Dec 05
BioPorto A/S Announces Resignation of Jan Leth Christensen as Board Member BioPorto A/S announced that Jan Leth Christensen has informed the Company that he has decided to resign from his position as a board member for BioPorto. The search for a successor with relevant expertise, including familiarity with public company practices in the Nordics, will be initiated and a new candidate is expected to be proposed in connection with the Company’s Annual General Meeting in 2024. Anuncio • Nov 01
Bioporto A/S Provides Revenue Guidance for the Fiscal Year 2023 BioPorto A/S provided revenue guidance for the fiscal year 2023, for the year, the company expects revenue of approximately DKK 30 million to DKK 33 million. Anuncio • Sep 20
Bioporto A/S Announces Resignation of Neil Goldman as CFO BioPorto A/S announced that Neil Goldman has informed the Company that he has decided to resign to take up the CFO position at another company. The search for a successor will be initiated and Neil Goldman will assist with the transition until a date to be determined. 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 German stocks, typically moving 9.8% 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 Risk Share price has been highly volatile over the past 3 months (9.8% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable next year (kr.66m net loss next year). Shareholders have been diluted in the past year (13% increase in shares outstanding). Revenue is less than US$5m (kr.30m revenue, or US$4.4m). Market cap is less than US$100m (€85.0m market cap, or US$93.3m). Anuncio • Aug 02
BioPorto A/S announced that it has received $0.11 million in funding On July 31, 2023, BioPorto A/S closed the transaction. The transaction included participation from 8 investor. Reported Earnings • Aug 02
Second quarter 2023 earnings released: kr.0.06 loss per share (vs kr.0.05 loss in 2Q 2022) Second quarter 2023 results: kr.0.06 loss per share (further deteriorated from kr.0.05 loss in 2Q 2022). Revenue: kr.7.75m (down 8.9% from 2Q 2022). Net loss: kr.19.6m (loss widened 15% from 2Q 2022). Revenue is forecast to grow 10% p.a. on average during the next 2 years, compared to a 14% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 15% per year but the company’s share price has fallen by 20% per year, which means it is significantly lagging earnings. Anuncio • Aug 01
BioPorto A/S Maintains Earnings Guidance for the Year 2023 BioPorto A/S maintained earnings guidance for the year 2023. Based on the progress and results obtained in the first six months of 2023, the company maintains its financial guidance for 2023. Revenue of approximately DKK 30 million to DKK 33 million. New Risk • Jun 25
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 13% 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 Risks Less than 1 year of cash runway based on free cash flow trend (-kr.62m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable next year (kr.65m net loss next year). Shareholders have been diluted in the past year (13% increase in shares outstanding). Revenue is less than US$5m (kr.31m revenue, or US$4.5m). Market cap is less than US$100m (€61.2m market cap, or US$66.6m). Board Change • May 18
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 1 experienced director. 6 highly experienced directors. Member of Scientific Advisory Board Hilde Geus is the most experienced director on the board, commencing their role in 2014. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Reported Earnings • May 11
First quarter 2023 earnings released: kr.0.05 loss per share (vs kr.0.06 loss in 1Q 2022) First quarter 2023 results: kr.0.05 loss per share (improved from kr.0.06 loss in 1Q 2022). Revenue: kr.8.04m (up 24% from 1Q 2022). Net loss: kr.16.1m (loss narrowed 5.7% from 1Q 2022). Over the last 3 years on average, earnings per share has increased by 20% per year but the company’s share price has fallen by 13% per year, which means it is significantly lagging earnings. Anuncio • May 11
BioPorto A/S Maintains Financial Guidance for 2023 BioPorto A/S maintained financial guidance for 2023. Based on the progress and results obtained in the first three months of 2023, BioPorto maintains its financial guidance for 2023, as most recently described in its Annual Report 2022 of: Revenue of approximately DKK 30 million to DKK 33 million. Reported Earnings • Mar 31
Full year 2022 earnings released: kr.0.24 loss per share (vs kr.0.21 loss in FY 2021) Full year 2022 results: kr.0.24 loss per share (further deteriorated from kr.0.21 loss in FY 2021). Revenue: kr.29.0m (up 19% from FY 2021). Net loss: kr.75.9m (loss widened 33% from FY 2021). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 16% per year, which means it is significantly lagging earnings. Anuncio • Dec 06
BioPorto A/S Appoints Nis Kruse as EVP of Strategic Partnerships and Gm of EMEA & Apac BioPorto A/S announced that Mr. Nis Kruse joined the Company as EVP of Strategic Partnerships and General Manager of EMEA & APAC. He will also serve as site leader for the Hellerup, Denmark office. Mr. Kruse most recently served as SVP & Chief Commercial Officer at SSI Diagnostica A/S, an in vitro diagnostics company focusing on infectious diseases, having delivered substantial topline growth in the company during the COVID pandemic. Previously, Mr. Kruse operated in a US-based position as Executive Director, Global Precision Medicine at Merck & Co., where he was responsible for Commercial Diagnostic Strategy and Commercial Partner Management related to Keytruda® across its numerous indications in immuno-oncology. Earlier in his career, Mr. Kruse held leadership roles in Copenhagen at Agilent Technologies, H. Lundbeck, and AstraZeneca. Mr. Kruse holds Master’s and Bachelor’s degrees in Economics and Business Management from University of Aarhus (Denmark). Mr. Kruse and his family are based in Copenhagen, and he will operate from the Company’s Hellerup office. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Chairman of the Board Chris Lindop was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Nov 11
Third quarter 2022 earnings released Third quarter 2022 results: Revenue: kr.5.27m (flat on 3Q 2021). Net loss: kr.16.9m (loss widened 48% from 3Q 2021). Revenue is expected to decline by 4.7% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Germany are expected to grow by 21%. Over the last 3 years on average, earnings per share has increased by 26% per year but the company’s share price has fallen by 10% per year, which means it is significantly lagging earnings. Anuncio • Nov 11
BioPorto A/S Submits Application for Marketing Authorization of NGAL Test to the US Food and Drug Administration BioPorto A/S has announced the submission of a De Novo application to the US Food and Drug Administration (FDA) of a neutrophil gelatinase-associated lipocalin (NGAL) test to aid in identifying pediatric patients (3 months to <22 years) at risk of moderate to severe AKI. The submission is supported in part by results from the recently completed GUIDANCE trial, which exceeded the Company's prespecified targets for test performance. The NGAL test received FDA Breakthrough Device Designation and is therefore expected to receive expedited review. If granted by the FDA, the NGAL test would be the first authorized pediatric AKI biomarker test commercially available in the US. The De Novo pathway creates a new classification for medical devices that do not have a predicate device for comparison. While awaiting the FDA's review of the submission, BioPorto will continue executing its commercialization strategy, including hiring personnel and continuing to prepare manufacturing and quality systems, while working to make the test available for the adult (age 22 and over) populations. Anuncio • Nov 10
BioPorto A/S Revises Earnings Guidance for the Year 2022 BioPorto A/S revised earnings guidance for the year 2022. The company has revised its 2022 guidance for operating (EBIT) loss from approximately DKK 95 to DKK 100 million down to approximately DKK 83 to DKK 88 million. The company maintains its 2022 revenue guidance of approximately DKK 24 to DKK 27 million. Anuncio • Aug 19
BioPorto A/S Revises Earnings Guidance for the Year 2022 BioPorto A/S revised earnings guidance for the year 2022. The company increases the upper end of its revenue guidance for the 2022 fiscal year, with a new range of DKK 24 to 27 million. The previous range was DKK 24 to 26 million. Operating (EBIT) loss of approximately DKK 95 to 100 million. Reported Earnings • Aug 18
Second quarter 2022 earnings released Second quarter 2022 results: Revenue: kr.8.50m (up 29% from 2Q 2021). Net loss: kr.17.1m (loss widened 26% from 2Q 2021). Over the next year, revenue is expected to shrink by 5.8% compared to a 11% growth forecast for the Biotechs industry in Germany. Anuncio • Jun 29
BioPorto A/S Achieves Targeted Enrollment in Clinical Study Supporting FDA De Novo Submission for The NGAL Test in the U.S BioPorto A/S (BioPorto) announced its achievement of targeted subject enrollment for the third part of a 3-part clinical study to support a U.S. Food and Drug Administration (FDA) De Novo submission for use of The NGAL Test in identifying patients under the age of 22 at risk for Acute Kidney Injury (AKI). Based on the quality of the clinical data and other material to support the desired claims, BioPorto anticipates submission of its De Novo application to the FDA by the fourth quarter of 2022. The NGAL Test has been granted Breakthrough Device designation by the FDA for expedited review. Breakthrough Device designation is granted for devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions, and where neither approved nor cleared alternatives exist. Anuncio • Jun 21
BioPorto A/S Appoints Dr. Prasad Devarajan as New Senior Medical Director BioPorto A/S announced the appointment of Dr. Prasad Devarajan, MD FAAP FASN, as Senior Medical Director effective July 1, 2022.Dr. Devarajan is considered a world leading Pediatric Nephrologist and physician-scientist and a pioneer in understanding the relationship between Neutrophil gelatinase-associated lipocalin (NGAL) and Acute Kidney Injury (AKI). Dr. Devarajan is Professor of Pediatrics & Developmental Biology, Director of Nephrology and Hypertension, and CEO of the Dialysis Unit at Cincinnati Children's Hospital Medical Center (Ohio, USA). He is the author of much of the most frequently cited peer-reviewed literature on the topics of kidney disease, nephrology, and renal disease. Dr. Devarajan will share his time between his directorships at Cincinnati Children's and his executive role at BioPorto. Anuncio • May 12
BioPorto A/S Maintains its Earnings Guidance for the Year 2022 BioPorto A/S maintained its earnings guidance for the year 2022. For the year, the company expects revenue of approximately DKK 24 million to 26 million and Operating (EBIT) loss of approximately DKK 95 million to 100 million. Board Change • May 02
Less than half of directors are independent There are 6 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 6 new directors. No experienced directors. 6 highly experienced directors. 2 independent directors (4 non-independent directors). Member of Scientific Advisory Board Hilde Geus is the most experienced director on the board, commencing their role in 2014. Independent Chairman of the Board Chris Lindop was the last independent director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Reported Earnings • Apr 07
Full year 2021 earnings released: kr.0.21 loss per share (vs kr.0.30 loss in FY 2020) Full year 2021 results: kr.0.21 loss per share (up from kr.0.30 loss in FY 2020). Revenue: kr.24.3m (up 4.5% from FY 2020). Net loss: kr.57.1m (loss narrowed 7.2% from FY 2020). Over the next year, revenue is forecast to grow 322%, compared to a 64% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 10% per year but the company’s share price has fallen by 30% per year, which means it is significantly lagging earnings. Anuncio • Mar 10
BioPorto A/S Provides Earnings Guidance for the Full Year 2022 BioPorto A/S provided earnings guidance for the full year 2022. For the year, the company expected Revenue of approximately DKK 24 to 26 million. Operating (EBIT) loss of approximately DKK 95 to 100 million. Reported Earnings • Nov 18
Third quarter 2021 earnings released: kr.0.04 loss per share (vs kr.0.087 loss in 3Q 2020) The company reported a solid third quarter result with reduced losses, improved revenues and improved control over expenses. Third quarter 2021 results: Revenue: kr.5.29m (up 12% from 3Q 2020). Net loss: kr.11.4m (loss narrowed 34% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 2% per year whereas the company’s share price has fallen by 3% per year. Reported Earnings • Aug 21
Second quarter 2021 earnings released: kr.0.051 loss per share (vs kr.0.077 loss in 2Q 2020) The company reported a decent second quarter result with reduced losses and improved control over expenses, although revenues were weaker. Second quarter 2021 results: Revenue: kr.6.58m (down 2.4% from 2Q 2020). Net loss: kr.13.6m (loss narrowed 12% from 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 5% per year whereas the company’s share price has fallen by 6% per year. Anuncio • Aug 20
BioPorto A/S Maintains Earnings Guidance for the Year 2021 BioPorto A/S maintained earnings guidance for the year 2021. Based on the progress and results obtained in first half of 2021, the company maintains its financial guidance for 2021, as most recently described in its interim report for the first quarter of 2021. Revenue of approximately DKK 30 million is expected in 2021. An operating loss (EBIT) of approximately DKK 73 million is forecast for the year. Anuncio • Jun 30
BioPorto A/S Provides Pipeline Update Regarding COVID-19 Test BioPorto A/S is currently developing a point-of-care test for SARS-CoV-2 on the proprietary gRAD platform designed to quickly and easily identify infected patients using a non-invasive sample. While indicative data from the process and studies in the US and Denmark supports the gRAD platforms strong capabilities as a technology for rapid testing, BioPorto has prioritized to secure a high sensitivity of more than 80% to further strengthen the clinical and commercial potential of the platform technology compared to other rapid test formats. Conditional upon continued access to patients with SARS-CoV-2, BioPorto expects the data collection to be completed in Third Quarter 2021. If data continues to support BioPorto’s initial laboratory findings, the company as previously announced intends to undertake CE mark filing in Europe and possibly submit an EUA request to the FDA. Reported Earnings • May 13
First quarter 2021 earnings released: kr.0.06 loss per share (vs kr.0.088 loss in 1Q 2020) The company reported a solid first quarter result with improved revenues and control over costs, although losses were not reduced. First quarter 2021 results: Revenue: kr.5.58m (up 33% from 1Q 2020). Net loss: kr.15.4m (flat on 1Q 2020). Over the last 3 years on average, earnings per share has fallen by 11% per year but the company’s share price has increased by 7% per year, which means it is well ahead of earnings. Anuncio • May 12
BioPorto A/S Provides Earning Guidance for the Year 2021 BioPorto A/S provided earning guidance for the year 2021. For the year, the company expected revenue of approximately DKK 30 million is expected in 2021. An operating loss (EBIT) of approximately DKK 73 million is forecast for the year. Executive Departure • May 06
Independent Vice Chairman Torben Nielsen has left the company On the 29th of April, Torben Nielsen's tenure as Independent Vice Chairman ended after 8.1 years in the role. As of December 2020, Torben personally held 301.93k shares (€144k worth at the time). A total of 2 executives have left over the last 12 months. Executive Departure • May 06
Independent Director has left the company On the 29th of April, Kirsten Drejer's tenure as Independent Director ended after 4.0 years in the role. As of December 2020, Kirsten personally held only 31.90k shares (€15k worth at the time). A total of 2 executives have left over the last 12 months. Reported Earnings • Mar 19
Full year 2020 earnings released: kr.0.30 loss per share (vs kr.0.41 loss in FY 2019) The company reported a soft full year result with weaker revenues and control over costs, although losses reduced. Full year 2020 results: Revenue: kr.23.2m (down 13% from FY 2019). Net loss: kr.61.6m (loss narrowed 12% from FY 2019). Anuncio • Mar 18
Bioporto A/S Provides Earnings Guidance for the Year 2021 BioPorto A/S provided earnings guidance for the year 2021. For the period, the company expects revenue of approximately DKK 30 million and an EBIT loss of approximately DKK 73 million. Anuncio • Mar 05
BioPorto Provides Pipeline Update BioPorto expects to complete its clinical study and submit a De Novo application to the FDA for pediatric use of The NGAL Test™ this summer. BioPorto awaits US test results for the rapid gRAD-based SARS-CoV-2 assay; if positive, the Company will proceed towards EUA and CE mark in the second quarter of 2021. In 2020, BioPorto A/S (BioPorto) began enrolling in a US clinical study for pediatric use of The NGAL Test for the risk assessment of acute kidney injury (AKI). The Company also undertook development of a novel SARS-CoV-2 viral test based on BioPorto’s Generic Rapid Assay Device (gRAD) platform. US application for The NGAL Test for pediatric AKI expected this summer. BioPorto’s studies of The NGAL Test that don’t require hospital enrollment are being finalized according to schedule. However, the study of critically ill (hospitalized) pediatric patients continues slowly due to delays caused by the second and third waves of the COVID-19 pandemic. As of the beginning of March 2021, eight US hospitals have successfully been recruited to participate in the pediatric trial of NGAL, and BioPorto is continuing to add new sites to boost enrollment. Subject to further changes brought about by COVID-19, the Company expects to complete its pivotal study this summer and submit a De Novo 510(k) application to the US Food and Drug Administration (FDA). Based on the gRAD platform, BioPorto has developed a point-of-care test for SARS-CoV-2 designed to quickly and easily identify infected patients using a non-invasive sample. In late December 2020, BioPorto provided its first kits to the University of California, Davis (US) for testing with samples from COVID-19 patients. After encountering initial issues in the trial, development teams on both sides of the Atlantic have worked together to resolve the challenges and BioPorto is currently awaiting outcome of the new testing. If results support BioPorto’s laboratory findings, the Company will progress with plans to submit an Emergency Use Authorization (EUA) request with the FDA and a CE mark filing in Europe in the second quarter of 2021. To further support the CE mark application, BioPorto is also evaluating options for conducting additional testing at clinical sites in Europe. 
