Athera initiates multiple dosing trial with its fully human antibody PC-mAb
Jan 30, 2017.

Stockholm Jan 30, 2016 Athera Biotechnologies AB today announced that first dosing in a multiple dosing study in healthy volunteers has been done with its fully human antibody PC-mAb, less than three weeks after regulatory authority approval.
“We are pleased to have executed our plans in such a timely manner and are looking forward to the results
from this multiple dosing trial with our PC-mAb” says Carina Schmidt, CEO of Athera. “The study is a preparation for the longer treatment with once monthly dosing in the planned Phase 2a study with severe peripheral arterial disease patients.”
Peripheral arterial disease, PAD, is a chronic disease that severely restricts the mobility of the patients and therefore their quality of life. It affects about 5% in ages 45-50 and 19% in ages 85-90. With severe PAD the disease is causing extensive pain also at rest, leading to further morbidity. Revascularization is performed to restore blood flow to reduce pain and restore mobility for the patients. However, the risk for severe events like heart attack and stroke is still high, as well as the risk for amputation of the affected limb. PC-mAb is designed to mimic the anti-inflammatory role of endogenous antibodies against PC and act to support the immune response to vascular inflammation challenges and thereby reduce the risk for complications in these patients.

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB
Phone: +46(0)76 1938 190, email: c.schmidt@athera.se


About Athera Biotechnologies AB

The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. In addition, Athera has developed a biomarker and companion diagnostics product, CVDefine® kit. The biomarker could in the future be used for identification of patients that benefit from Athera’s novel therapeutics. Development of PC-mAb has been co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB. For more information: www.athera.se




Low levels of endogenous anti-PC identified as a novel risk factor for vein bypass graft failure and cardiovascular complications in PAD patients
Sep 29, 2016.

Copenhagen September 29, 2016 Professor Michael Sobel, vascular surgeon at University of Washington in Seattle, USA presents new data from a prospective, observational study of 142 patients with peripheral artery disease (PAD) undergoing vein bypass at the at the annual meeting of ESVS (European Society of Vascular Surgeons) in Copenhagen. The primary outcome of this study was the loss of primary patency in the intervened blood vessel, and secondary endpoint was a composite of vessel failure, heart attack and stroke.

The study concludes that low levels of the naturally occurring anti-PC (endogenous antibodies towards phosphorylcholine) are linked with vein bypass graft failure, and that high anti-PC levels seems to be protective. The beneficial effects of anti-PC are suggested to be mediated by the anti-inflammatory actions, which are thought to quench the inflammatory effects of the exposed PC in damaged vascular cells. This novel biological mediator may be a useful marker to identify patients at higher risk of graft failure, and offers the potential for novel, directed therapies for vascular inflammation and its serious consequences. Endogenous IgM anti-PC was measured in blood samples from the patients using CVDefine® kit from Athera Biotechnologies.

PAD is a chronic disease that severely restricts the mobility of the patients and therefore their quality of life. It affects about 5% in ages 45-50 and 19% in ages 85-90. With severe PAD the disease is causing extensive pain also at rest, leading to further morbidity. Vein graft intervention is performed to restore blood flow to reduce pain and restore mobility for the patients. However, the risk for severe events like heart attack and stroke is still high, as well as the risk for amputation of the affected limb.

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email:c.schmidt@athera.se

About Athera Biotechnologies AB
The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. In addition, Athera has developed a biomarker and companion diagnostics product, CVDefine® kit. The biomarker could in the future be used for identification of patients that benefit from Athera’s novel therapeutics. Development of PC-mAb is co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB. For more information: www.athera.se




Athera presents positive First-in-Patient data with their new antibody against immunovascular disease at ESVS
Sep 28, 2016.

Copenhagen September 28, 2016 Athera Biotechnologies AB, a privately held biopharmaceutical company focused on developing a new antibody against immunovascular diseases, presents data from the first study in patients with peripheral artery disease (PAD) at the annual meeting of ESVS (European Society of Vascular Surgeons) in Copenhagen. Conclusions from this Phase 1b study in PAD patients were positive, showing good safety and tolerability, as well as antibody properties supporting once monthly dosing also in patients. The study, run at Karolinska University Hospital in Stockholm, included 12 patients receiving a single dose of Athera’s lead candidate PC-mAb or placebo.

Professor Gunnar Olsson, Chairman of the Board, said “The study data confirms that there are generally low levels of endogenous antibodies to phosphorylcholine, anti-PC, in PAD patients, indicating a window for reconstitution therapy with PC-mAb. We also noted that PAD patients have markedly reduced limb arterial dynamic functionality, which was an important observation for future clinical study designs. This really give a good base for succinct definitions of clinically relevant endpoints in the planned phase IIa study in this patient group.”

“We are very pleased to have reached this important milestone and to be able to report safety data supporting next development steps, efficacy trials with PC-mAb, said Athera CEO Carina Schmidt. “We think PC-mAb has significant potential to address unmet medical needs in PAD, but also in other immunovascular diseases, and this should represent a significant value for an industrial partner.”

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email:c.schmidt@athera.se

About Athera Biotechnologies AB
The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. In addition, Athera has developed a biomarker and companion diagnostics product, CVDefine® kit. The biomarker could in the future be used for identification of patients that benefit from Athera’s novel therapeutics. PC-mAb provides an opportunity to address the need for improved secondary prevention after revascularization in severe PAD patients and reduce the associated risks for complications and new vascular disease events. PAD is a chronic disease that severely restricts the mobility of the patients and therefore their quality of life. It affects about 5% in ages 45-50 and 19% in ages 85-90. With severe PAD the disease is causing extensive pain also at rest, leading to further morbidity. The risk for severe events like heart attack and stroke is high, as well as the risk for amputation of the affected limbs. Development of PC-mAb is co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB. For more information: www.athera.se




Athera Biotechnologies completes First-in-Patient Study with new antibody against immunovascular disease
Aug 11, 2016.

Stockholm August 11, 2016 Athera Biotechnologies AB, a privately held biopharmaceutical company focused on developing a new antibody against immunovascular diseases, reports that the first study in patients with peripheral artery disease (PAD) is now completed. Results will be presented at the ESVS (European Society of Vascular Surgeons) annual meeting in Copenhagen in September.

The completed Phase 1b study in PAD patients was initiated late 2015 at Karolinska University Hospital in Stockholm, and includes 12 patients receiving a single dose of Athera’s lead candidate PC-mAb or placebo. A First-in-Man study had successfully been completed earlier in 2015. The double-blinded Phase 1a study with 48 healthy volunteers, randomized to administration of PC-mAb or placebo, supported that the antibody was generally safe and well tolerated with no serious adverse events related to study drug administration, as well as having desired antibody properties for once-monthly administration.

PC-mAb provides an opportunity to address the need for improved secondary prevention after revascularization in severe PAD patients and reduce the associated risks for complications and new vascular disease events. PAD is a chronic disease that severely restricts the mobility of the patients and therefore their quality of life. It affects about 5% in ages 45-50 and 19% in ages 85-90. With severe PAD the disease is causing extensive pain also at rest, leading to further morbidity. The risk for severe events like heart attack and stroke is high, as well as the risk for amputation of the affected limbs.

Professor Gunnar Olsson, Chairman of the Board, said “Prevention of complications in patients with severe PAD represents a large unmet medical need, since such complications are not uncommon and there is presently little to offer to reduce risk. PC-mAb represents a great opportunity to contribute to better treatment for these patients. Additionally, PC-mAb has significant potential to address unmet medical needs in other immunovascular diseases, and these indications should represent a significant value for a partner.”
“I am excited with the completion of this first patient study with our fully human antibody PC-mAb,”, said Athera CEO Carina Schmidt. “Athera is now pushing forward towards efficacy trials, hopefully together with an industrial partner.”

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email: c.schmidt@athera.se

About Athera Biotechnologies AB
The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. In addition, Athera has developed a biomarker and companion diagnostics product, CVDefine® kit. The biomarker could in the future be used for identification of patients that benefit from Athera’s novel therapeutics. Development of PC-mAb is co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB. For more information: www.athera.se




Athera Biotechnologies completes 24 million SEK financing
Dec 3, 2015.

Stockholm December 3, 2015 Athera Biotechnologies AB, a privately held biopharmaceutical company focused on developing a new antibody against cardiovascular diseases, has completed a 24 million SEK financing from a consortium led by The Foundation for Baltic and East European Studies (Östersjöstiftelsen), Industrifonden and Linc Invest. Additional investors in the consortium are Athera´s Board and management, as well as other investors, including Antaros Medical AB. Dr. Jonas Brambeck, Investment Manager at Industrifonden, will join the Board of Directors.
The 24 million SEK will be used to finance further clinical development of Athera’s lead project PC-mAb, currently in clinical Phase I studies, to become a Phase 2-ready project. PC-mAb provides an opportunity to address the need for improved secondary prevention after revascularization in severe peripheral artery disease (PAD) patients and reduce the associated risks for complications and new cardiovascular disease (CVD) events.

“This marks the beginning of an exciting period for Athera, securing the necessary funding for completing the Phase 1 study in patients and prepare for Phase 2 studies with our fully human antibody PC-mAb,”, said Athera CEO Carina Schmidt. “The new ownership structure will give us access to an excellent platform of experience and capacities that will facilitate our preparations to secure an industrial partner for late clinical development and commercialization.”

Dr Gunnar Olsson, Chairman of the Board, said “Athera´s candidate drug has significant potential to address unmet medical needs in cardiovascular disease. Prevention of complications in patients with severe PAD represents an important niche market and PC-mAb has great opportunities to contribute to better treatment for these patients.”
“We are very pleased with this investment in Athera,” said Mattias Klintemar, Director of Investments for Östersjöstiftelsen “We were an early investor in this interesting company with a unique and promising cardiovascular drug candidate in early clinical development. We are now looking forward to continue our support in the company to achieve its clinical and commercial milestones during the coming years.”

For more information contact:
Jonas Brambeck, Investment Manager, Industrifonden
Phone: +46 (0) 708 791 937 , email:
Jonas.brambeck@industrifonden.se
Carina Schmidt, CEO, Athera Biotechnologies AB
Phone: +46 (0)76 1938 190, email: c.schmidt@athera.se
Mattias Klintemar, Director of Investments, Östersjöstiftelsen
Phone: +46 (0)70 932 64 67, email: mattias.klintemar@ostersjostiftelsen.se

About Athera Biotechnologies AB
The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of cardiovascular disease (CVD). Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. In addition, Athera has developed a biomarker and companion diagnostics product, CVDefine® kit. The biomarker, anti-PC, is linked to increased risk for CVD and could in the future be used for identification of patients that benefit from Athera’s novel therapeutics. Development of PC-mAb is co-funded by EU FP7 in the CARDIMMUN project that was started in 2013. For more information: www.athera.se

About Industrifonden
Industrifonden is one of Sweden’s most experienced and active investors in early-stage tech and life science companies aiming for international growth. We are a long-term partner with about SEK 4 billion in assets and serve as an active owner together with entrepreneurs and co-investors. Our passion is to build lasting value and successful companies. For further information, visit www.industrifonden.com or twitter.com/industrifonden

About The Foundation for Baltic and East European Studies (Östersjöstiftelsen)
Östersjöstiftelsen (the Foundation for Baltic and East European Studies) was founded by the Swedish government in 1994 to support research, doctoral studies and academic infrastructure at Södertörn University. Östersjöstiftelsen has funded approximately 200 research projects and the education of 140 doctoral students at Södertörn University. From 2000 to 2015, Södertörn University has been granted funds totalling SEK 3 billion. In October 2015, the Foundation managed assets totaling over SEK 5 billion.

About Linc Invest AB
Linc invest AB invests in Life Science companies. The main investments are in Pharmalink, MedCap, Stille, Arcoma, SweVet, Bringwell and Boule. For further information, contact Bengt Julander +46 70 319 5909, bengt.julander@linc.se

About Antaros Medical AB
Antaros Medical AB is a Swedish company pioneering new frontiers in innovative MRI & PET imaging techniques in clinical drug development to improve understanding of human pathophysiology. We enable decision makers to optimize outcomes and minimize risk. Our current customers include both small and big pharma companies. For more information: www.antarosmedical.com




The option rights with Athera will not be exercised due to re-evaluation of Boehringer Ingelheim’s R&D strategy – clinical development of Athera’s antibody proceeds as planned
Nov 12, 2014.

STOCKHOLM – November 12, 2014. Athera Biotechnologies AB, a Karolinska Development AB portfolio company, today announced that Boehringer Ingelheim International GmbH will not exercise the option agreement to license Athera’s cardiovascular antibody due to
re-evaluation of Boehringer Ingelheim’s R&D strategy. The ongoing clinical development program at Athera of the fully human antibody PC-mAb is not affected by the termination of the agreement.

Athera’s fully human monoclonal antibody PC-mAb is intended for the treatment of patients with cardiovascular disease, who are at an increased risk of secondary events and death. Boehringer Ingelheim’s decision to terminate the option agreement has been made as a consequence of a re-focus in its corporate R&D strategy. Athera’s ongoing Phase I study with PC-mAb will proceed as planned and the co-financing of future development costs through the EU FP7 program CARDIMMUN is not affected by Boehringer Ingelheim’s decision.

“Boehringer Ingelheim’s vast experience and resources within the cardiovascular field has significantly contributed to the successful progress of PC-mAb into the clinical development stage. We will now pursue work within the EU FP7 project CARDIMMUN, aiming to generate proof-of-activity data, and Athera will initiate activities to secure a new strategic partner for the later phases of clinical development and commercialization”, said Carina Schmidt, CEO of Athera Biotechnologies.

NOTE: Karolinska Development owns 65% of Athera Biotechnologies which includes indirect ownership through KCIF Co-Investment Fund KB.

For further information, please contact:

Carina Schmidt, CEO, Athera Biotechnologies AB
Phone: +46 76 193 81 90 e-mail: c.schmidt@athera.se

Bruno Lucidi, CEO, Karolinska Development AB
Phone: +46 72 245 9892 e-mail: bruno.lucidi@karolinskadevelopment.com




Athera initiates Phase I trial with its fully human antibody PC-mAb
Oct 21, 2014.

STOCKHOLM, SWEDEN – October 21, 2014. Athera Biotechnologies AB, a Karolinska Development
AB portfolio company, today announced that first dosing of healthy volunteers has been done in a
Phase I study of its fully human antibody PC-mAb. This lead product candidate targets the
inflammatory component of cardiovascular disease, where current therapies are considered to be
inadequate.

“We are pleased to have executed our plans in a very timely manner and are looking forward to the results
from this important first clinical trial with our PC-mAb” says Carina Schmidt, CEO of Athera. “This is a key
achievement for the EU FP7 project CARDIMMUN, aiming to generate proof-of-activity data for PC-mAb.”

“I am delighted to see this pharmaceutical project for such life threatening conditions leaving the lab benches
to enter clinical trials”, says Bruno Lucidi, CEO of Karolinska Development.

Athera’s fully human monoclonal antibody PC-mAb is intended for the treatment of patients with
cardiovascular disease, who are at an increased risk of secondary events and death. It is known from previous
published studies that low plasma levels of endogenous antibodies against phosphorylcholine (anti-PC) are
linked to poor prognosis in acute heart attack patients, as well as in patients with peripheral arterial disease
undergoing vein graft surgery. The current Phase I study will include up to 48 healthy volunteers in a single
ascending dose protocol with safety outcome measures and is performed in Uppsala by CTC Clinical Trial
Consultants AB.

The development costs for Athera’s lead product candidate are co-financed by the EU FP7 program, within the
project CARDIMMUN.

NOTE: Karolinska Development owns 65% of Athera Biotechnologies which includes indirect ownership through
KCIF Co-Investment Fund KB.

For further information, please contact:
Carina Schmidt, Chief Executive Officer, Athera Biotechnologies AB
Phone: +46 76 193 81 90 email: c.schmidt@athera.se
Bruno Lucidi, Chief Executive Officer, Karolinska Development AB,
Phone: +46 72 245 9892, email: bruno.lucidi@karolinskadevelopment.com




Athera elects new Chairman of the Board and moves to new premises
Sep 19, 2013.

Sept 19, 2013. Gunnar Olsson, former head of the global CV/GI team in AstraZeneca, has been elected new Chairman of the Board. Earlier this year, Tomas Odergren, VP Clinical Development at Karolinska Development AB, joined the Board of Directors. The extraordinary shareholders meeting in Athera has elected Gunnar Olsson new Chairman of the Board after Per Sjöberg, who has been leading the company for eight years. Dr Olsson joins Athera after 24 years in AstraZeneca, where he has held several senior management positions, mainly within therapy area leadership for cardiovascular and gastrointestinal disease. He holds an MD and PhD from Karolinska Institutet and is specialist in Cardiology and Internal Medicine. Dr Olsson is Honorary Doctor of Medicine at Gothenburg University. Tomas Odergren, MD, PhD and specialist in Neurology, joined the Board of Directors at the Annual General Meeting in June, and he brings an excellent and well-timed expertise in clinical development. Otto Skolling remains on the Board, while Paul de Potocki and Per Sjöberg resign. The company has recently moved their office to new premises at Business Center on Sankt Eriksgatan 117 in Stockholm, next to Hagastaden and the new Karolinska Hospital.




Athera and Boehringer Ingelheim enter into an option agreement on a novel therapy for Atherosclerosis
Jun 19, 2013.

June 19, 2013. Athera has entered into an option agreement with Boehringer Ingelheim International GmbH on a novel preclinical antibody program, whereby Athera grants to Boehringer Ingelheim an exclusive option to acquire the entire program. Karolinska Development AB owns 65% of Athera Biotechnologies AB. Athera’s fully-human monoclonal antibody is intended for the treatment of patients with cardiovascular disease, who are at an increased risk of secondary events and death. Pursuant to the terms of the option agreement, Athera will conduct defined preclinical development and a Phase I study for the lead antibody and, following the completion of such study, Boehringer Ingelheim will have an exclusive option to acquire substantially all of Athera’s assets and rights relating to the program. In exchange for Athera’s granting of the option, Boehringer Ingelheim will pay an option fee. The size of the fee and the other terms of the option are not being disclosed but this transaction is in line with market average terms for programs at similar stages of development.




EU grants EUR 6m to the clinical development of Athera´s cardiovascular disease antibody therapy
Jun 17, 2013.

June 17, 2013. Future development costs of its fully human antibody PC-mAb up until proof-of-concept will be co-funded by the European Union’s Seventh Framework Programme for Research (FP7) through a collaborative research grant. Karolinska Development AB owns 65% of Athera Biotechnologies AB. Athera’s fully human monoclonal antibody PC-mAb is targeting phosphorylcholine and is being developed for the treatment of patients with an increased risk of atherosclerosis related cardiovascular events and death. This includes myocardial infarction patients and patients with peripheral arterial disease undergoing vein graft surgery. The EUR 6m grant has been provided to the CARDIMMUN consortium, consisting of Athera, Leiden University Medical Center (LUMC), Turku PET Center (Turku University), Clinical Trial Consultants (CTC) and Smerud Medical Research. The project has a total budget of nearly EUR 8m and will be running over three years, focusing on key preclinical activities and clinical trials aimed at demonstrating proof-of-concept of this new cardiovascular treatment. LUMC is the project coordinator and will be leading the project together with Athera.