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02.07.2024

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Sterna biologicals raises further EUR 10.0 million (Aprox. USD 11.9 million) in series A- 2nd closing private placement

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07.01.2021

• Following successful completion of the company’s Series A – 1st closing with EUR 12.0 million in April 2020, sterna now has successfully completed a 2nd closing with another EUR 10.0 million, bringing the Series A total to EUR 22.0 million • Proceeds from the 2nd closing will fund phase IIb preparatory activities including toxicology studies and CMC work for SB010 in moderate to severe asthma as well as the completion of an oral formulation project for SB012 laying the foundation for phase I/IIb studies in moderate to severe ulcerative colitis • sterna’s approach to down-regulate master transcription factor GATA-3 using a DNAzyme (enzymatic antisense oligonucleotide) could provide a truly novel, first-in-class, broad-spectrum, non-steroidal, anti-inflammatory therapy across type 2 inflammatory diseases Marburg, Germany, January 07, 2021 – sterna biologicals GmbH & Co. KG (sterna), an innovative clinical-stage immunology company developing novel biological treatments for chronic inflammatory diseases, today announced that the company has secured EUR 10.0 million (approx. USD 11.9 million) in a 2nd closing of its Series A private placement. Proceeds will fund toxicology and CMC (chemistry, manufacturing and controls) work preparing the company for the initiation of a phase IIb trial with SB010 in patients with moderate to severe asthma. The funds will further be used for the completion of the ongoing oral formulation project for SB012 in preparation of phase I/IIb studies in moderate to severe ulcerative colitis patients. sterna is currently preparing a phase IIa proof-of-concept study with SB010 in patients with moderate to severe asthma. According to current development plans, sterna expects clinical data from its POC study in 2022 and is planning to start phase IIb development in 2023. In parallel, the company has initiated an oral formulation project for SB012. Once a final oral formulation candidate is available, phase I/IIb studies could start as early as in the first half of 2023. “We thank our investors for their continuous support and strong vote of confidence in our highly promising treatment approach as well as our comprehensive non-clinical and clinical data package. Their financial commitment enables us to pursue the most rapid development scenario for SB010 in moderate to severe asthma and SB012 in moderate to severe ulcerative colitis”, said Christian Pangratz, Chief Executive Officer of sterna biologicals. sterna’s novel and unique approach to down-regulate GATA-3 with the company’s proprietary active pharmaceutical ingredient hgd40, a special type of catalytic antisense oligonucleotide – a DNAzyme – could provide for a truly novel, first-in-class, broad-spectrum, non-steroidal, anti-inflammatory therapy. Down-regulating GATA-3 leads to a reduced expression of several key inflammatory cytokines and thereby normalization of the dysregulated type 2 immunity (immunomodulation). Consequently, the company’s therapies SB010 and SB012 containing hgd40 address several inflammatory processes simultaneously and rebalance an overall dysregulated immune response. Broad-spectrum topical therapeutics like SB010 and SB012 therefore, allow to treat type 2 inflammatory diseases safely and efficaciously as sterna already demonstrated in previous clinical studies. Phase IIa proof-of-concept (POC) study with SB010 in patients with moderate to severe asthma to be initiated – building on compelling proof-of-principle data in mild asthmatics sterna is preparing a phase IIa POC study with SB010 in patients with moderate to severe asthma. The company expects clinical data in 2022 and is planning to start phase IIb development in 2023. In a randomized, double-blind, placebo-controlled parallel group, multi-center phase IIa proof-of-principle trial with mild asthmatics published in the New England Journal of Medicine, local administration of SB010 led to a statistically significant improvement in lung function versus placebo in both early- and late-phase asthmatic response [Krug et al., New Engl J Med. (2015)]. Treatment with SB010 was safe and well tolerated. Oral formulation of SB012 for patients with moderate to severe ulcerative colitis - optimizing administration sterna is currently developing an oral formulation of hgd40 to be used in phase I/IIb clinical development with patients suffering from moderate to severe ulcerative colitis. First feasibility work was successfully completed, and the company is now in the process of finalizing a novel colon-targeting drug product candidate leveraging commercially validated technology. In a prospective, multi-center, randomized, double-blind, placebo-controlled phase IIa POC trial with moderate to severe ulcerative colitis patients, rectal administration of SB012 was well tolerated and lead to marked clinical and endoscopic improvement. About Sterna Biologicals   sterna biologicals GmbH & Co. KG is an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases such as asthma, chronic obstructive pulmonary disease (COPD), atopic dermatitis, and ulcerative colitis. By targeting transcription factors that play a central role in regulating inflammatory mechanisms, the Company’s proprietary DNAzyme-based drug candidates can intervene with key inflammatory processes to address related diseases more effectively. So far, sterna has advanced four programs into phase 2 development. For more information, please visit www.sterna-biologicals.com.

DAK-Gesundheit verlängert Kooperation mit Nia Health

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06.01.2021

App für Hilfe im Umgang mit Neurodermitis bei Kindern Hamburg, 6. Januar 2021. Die DAK-Gesundheit verlängert die Kooperation mit Nia Health bis zum 31. Dezember 2021. DAK-Versicherte können die Premiumversion der App Nia ab sofort bis zum Jahresende 2021 kostenfrei verwenden. Nia ist die meistgenutzte Neurodermitis-App im deutschsprachigen Raum und die erste als Medizinprodukt zugelassene App dieser Art weltweit. Jedes zwölfte Kind in Deutschland leidet an Neurodermitis. Das ist das Ergebnis des vergangenen Kinder- und Jugendreports der DAK-Gesundheit. Damit ist Neurodermitis die am meisten verbreitete chronische Erkrankung im Kindes- und Jugendalter. Sie ist eine chronisch und schubweise verlaufende entzündliche Hauterkrankung. Symptome sind eine empfindliche und trockene Haut, Rötungen und Juckreiz. Als Ergänzung zur Behandlung beim Kinderarzt bietet die DAK-Gesundheit ihren Versicherten bereits seit dem Sommer die App Nia an, die Eltern im Umgang mit Neurodermitis bei ihren Kindern digital unterstützt. In der Neurodermitis-App Nia können Symptome digital dokumentiert werden. Eltern erhalten zudem viele Tipps und Hintergrundwissen rund um die Themen Medikamente und Körperpflege. Nia Health Co-Gründer Tobias Seidl zeigt sich erfreut über das entgegengebrachte Vertrauen seitens der DAK-Gesundheit: „Die Zusammenarbeit mit der DAK-Gesundheit fand von der ersten Stunde an auf Augenhöhe statt. Wir sind sehr froh, einen Partner an unserer Seite zu haben, der sich so stark für das Wohlergehen von Familien engagiert.” DAK-Versicherte mit Kindern bis acht Jahren, die bereits Nia Premium über das Kooperationsangebot nutzen, können den Nia Service wie gewohnt noch über ein Jahr kostenfrei weiter nutzen. Für alle Neuanmeldungen verlängert sich die Nutzungsdauer der ursprünglich angebotenen sechs Monate natürlich ebenfalls bis Ende 2021. Weitere Informationen zur Kooperation sind unter www.dak.de/nia zu finden.

Atriva Therapeutics obtains approval from German authorities for Phase II trial in COVID-19 patients, led by Charité Clinic in Berlin

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05.01.2021

• RESPIRE is a placebo-controlled, international, multi-center trial treating hospitalized patients with moderate to severe COVID-19 • The Phase II clinical trial will evaluate efficacy, safety and pharmacokinetics of ATR-002, an orally available small molecule with a beneficial dual antiviral and immunomodulatory effect • Charité – Universitätsmedizin Berlin, and further German and international clinical trial sites to start enrollment of 220 patients  Tübingen and Frankfurt (Germany), January 5th, 2021 – Atriva Therapeutics GmbH, a biopharmaceutical company pioneering the development of host-targeting antiviral therapies, announced today approval from the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) to initiate a pivotal Phase II clinical study with ATR-002 to treat hospitalized patients with moderate to severe COVID-19. RESPIRE is a randomized, double-blind, placebo-controlled, international, multi-center Phase II clinical trial in 220 adult patients with moderate to severe COVID-19, requiring hospitalization, but not requiring ICU admission or ventilator support at the time of screening or randomization. On top of standard of care, half the patients will receive ATR-002 900 mg, administered as tablets once daily on day 1, followed by ATR-002 600 mg once daily on days 2 to 6. Patients in the control group will receive placebo in a matching scheme, on top of standard of care. Primary endpoint of the study is to prove the efficacy of ATR-002 versus placebo in addition to standard of care; secondary endpoints include the measurement of changes in clinical signs and symptoms and other relevant clinical parameters, scores, and study events. Outcomes will be assessed based on the clinical severity status on day 15, using a 7-point ordinal scale as suggested by the WHO COVID-19 Therapeutic Trial Synopsis. All patients will be followed up for 90 days. The study will also evaluate the pharmacokinetics of ATR-002. The Atriva lead candidate ATR-002 is a small molecule developed specifically to treat respiratory viral infections by inhibiting MEK, a host cell factor required for the replication of various RNA viruses, including influenza virus and SARS-CoV-2. MEK also modulatescytokine and chemokine release. Due to this mode of action with a dual benefit, ATR-002 not only inhibits viral replication but could also prevent a cytokine storm and the associated disease progression to a life-threatening condition and, thus, reduce the resulting burden on hospitals and healthcare systems. “We are delighted to receive this approval from the German authorities and are grateful for their positive feedback and encouragement. At the same time, we are preparing for additional approvals to involve clinical centers in other European and Non-European countries,” said Dr. Rainer Lichtenberger, co-founder and CEO of Atriva. “After the recent financing and commitment from our investors, this authorization further enhances the clinical development program of ATR-002, the only host-targeted antiviral specifically developed to treat respiratory RNA virus infections.” Prof. Martin Witzenrath, M.D., Vice Director Department of Infectious Diseases and Respiratory Medicine at Charité – Universitätsmedizin Berlin, Germany, will act as Global Coordinating Investigator. The study will be run at Charité and additional German and international clinical centers. Explaining the significance of the study, Prof. Martin Witzenrath said: “There is an urgent need for an effective treatment to stop COVID-19 patients from progressing to critical conditions requiring intensive care and causing potentially permanent health issues and even death. ATR- 002’s capability to both fight the virus and combat the excessive immune response that we see in patients with moderate or severe COVID-19 makes it a very promising therapeutic candidate for this patient population. We are confident that this pivotal study will quickly lead to an effective treatment for the patients most severely affected by this disease.” “Starting a Phase II clinical trial with ATR-002 in patients suffering from COVID-19 is an important step for Atriva and we have every confidence in the expertise and support of the Charité medical team to lead this study. With this trial, we intend to rapidly advance our drug candidate so patients in need for therapeutic options can potentially benefit from it. Ultimately, our goal is to provide a safe antiviral that can help treat not only infections with SARS-CoV-2, but also influenza and future emerging RNA virus outbreaks,” concluded Dr. Martin Bauer, M.D., FNWC, Atriva’s Chief Medical Officer. About ATR-002’s mode of action with dual benefit The Atriva lead product ATR-002 is developed specifically to treat diseases such as influenza and COVID-19, caused by RNA viruses. ATR-002 is a clinical stage MEK inhibitor drug candidate targeting the intracellular Raf/MEK/ERK signaling pathway. This pathway is central for replication of many RNA viruses, such as the influenza virus, hantavirus or respiratory syncytial virus (RSV) and also SARS-CoV-2, the virus that causes COVID-19. In influenza virus infected cells, the interaction of ATR-002 with MEK (MAPK/ERK kinase) prevents export of the viral genome protein complexes (ribonucleoprotein, RNP) from the nucleus to the cytoplasm, thus blocking the formation of functional new viral particles. This ultimately reduces the viral load in the body. In addition, ATR-002 has the potential to modulate the pro-inflammatory cytokine response of the body, avoiding overshooting cytokine response that can be caused by such viral infections. MEK inhibition can reduce the gene expression of some of the cytokines involved, like TNF-α, IL-1ß, IP-10, IL-8, MCP-1 and MIP-1a, and thus mitigate the overactive inflammatory response in the lungs of patients who are severely ill with influenza or COVID-19. About Atriva Therapeutics GmbH Atriva Therapeutics, founded in 2015, is a biopharmaceutical company pioneering the development of host-targeting antiviral therapies set up by a team of leading scientists in viral research and seasoned industry experts. The Company aims to develop a therapy platform to treat severe respiratory diseases induced by RNA viruses with a high unmet medical need, such as influenza and COVID-19. The Atriva lead product ATR-002 is a first-in-class host- targeting agent which inhibits viral replication in influenza and favorably modulates the body’s immune response. ATR-002 is under clinical development and has successfully completed a Phase I trial to demonstrate safety and tolerability in healthy subjects. The Company has obtained regulatory approval for a Phase II study to evaluate efficacy in hospitalized COVID- 19 patients; a Phase II study in influenza is planned to start later in 2021. The Company owns eleven patent families with broad international coverage related to the use of MEK inhibitors and other kinase inhibitors for antiviral therapies. The patent life runs through 2041. Atriva Therapeutics is located in Tübingen and Frankfurt, Germany. Atriva is a founding member of the BEAT-COV initiative www.beat-cov.de. For further information, please visit www.atriva-therapeutics.com and follow us on LinkedIn and Twitter.

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