Athera concludes follow-up visits in multiple dosing trial with its immunovascular antibody
Sep 19, 2017.

Stockholm Sep19, 2017 Athera Biotechnologies AB today announced that all follow-up visits (12 weeks after last dosing) in a multiple dosing study in healthy volunteers with its fully human antibody PC-mAb have been completed. Positive preliminary safety and pharmacokinetics data provides continued support for further clinical development with once monthly administrations.

“We are very happy with the preliminary data of this study which supports our development plans and the upcoming initiation of the next Phase 2a study”, says Carina Schmidt, CEO of Athera.

The fully human 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.

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




Athera completes financing to advance clinic with immunovascular antibody
Aug 29, 2017.

Stockholm August 29, 2017

Athera Biotechnologies AB has completed a 57 million SEK financing from current major owners; The Foundation for Baltic and East European Studies (Östersjöstiftelsen), Industrifonden and Linc AB, together with new investor Ribbskottet AB, an investment company lead by Anders Bladh. Mr Bladh has a long background from international asset management, finance and banking as well as real estate. Additional investors include Athera´s management team and Antaros Medical AB.

The 57 million SEK will be used to fully finance the next steps in clinical development of Athera’s lead project PC-mAb, currently preparing for start of clinical Phase 2. 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.

“This marks the start of a game-changing period for Athera, securing the necessary funding for the next Phase 2 study with our fully human antibody PC-mAb,”, says Athera CEO Carina Schmidt. “The new ownership will further strengthen our team and support the development of this exciting compound in a market with high medical need.”

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




EXTRA BOLAGSSTÄMMA I ATHERA BIOTECHNOLOGIES AB  (Swedish only)
Aug 14, 2017.

Aktieägarna i Athera Biotechnologies AB (org. nr 556620-6859) kallas härmed till extra bolagsstämma. 

Plats: S:t Eriksgatan 117, Business Center, plan 4
Tid: Den 4 september 2017, kl 16.00

Rätt att delta
Vi är tacksamma om ni anmäler er avsikt att delta i bolagsstämman till Bolaget enligt nedan senast den 31 augusti 2017.

Anmälan  
Anmälan om deltagande kan göras per e-post till c.schmidt@athera.se. 
Vid anmälan skall aktieägaren uppge namn, person-/organisationsnummer, adress och telefonnummer samt i förekommande fall antalet biträden. Aktieägare kan delta och rösta i bolagsstämman personligen eller genom ombud. Ombud för juridiska personer skall presentera en kopia av den juridiska personens registreringsbevis eller annan handling utvisande rätten att handla å den juridiska personens vägnar. 

All dokumentation rörande bolagsstämman kommer att finnas tillgänglig på Bolagets kontor två veckor före dagen för bolagsstämman och kommer att skickas till aktieägare på begäran. Förslag till dagordning bilägges.
__________
Styrelsen för Athera Biotechnologies AB
FÖRSLAG TILL DAGORDNING FÖR EXTRA BOLAGSSTÄMMA i bolagets lokaler i Stockholm, S:t ERIKSGATAN 117, plan 4 den 4 SEPTEMBER 2017 kl 16.00

Öppnande av Stämman
Val av ordförande och protokollförare vid Stämman
Upprättande och godkännande av röstlängd
Val av justeringsmän att jämte ordförande justera protokollet vid stämman
Prövning om Stämman blivit I behörig ordning sammankallad
Godkännande av dagordning
Information från bolagets verkställande direktör
Beslut om emission av teckningsoptioner
Stämmans avslutande




Athera Receives FDA Orphan Drug Designation for PC-mAb in prevention of vascular access failure in kidney disease patients
Jun 21, 2017.

Stockholm June 21, 2017 Athera Biotechnologies AB announced today that the the U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to the fully human antibody PC-mAb, for the treatment of patients with end stage renal disease, and who are preparing for or undergo hemodialysis, to prevent vascular access failure.

“We are pleased that the FDA have granted orphan drug designation to our therapeutic candidate PC-mAb.” says Carina Schmidt, CEO of Athera. “The granting highlights the great unmet medical need for new therapies for kidney disease patients, who are dependent on a well-functioning vascular access for their hemodialysis.”

End stage renal disease (ESRD) patients have a loss of kidney function and require either dialysis or a kidney transplant to survive. All patients on hemodialysis require a reliable vascular access. It has been estimated that 20% of all hospitalizations in the hemodialysis population are due to vascular access dysfunction. Creation of a well-functioning vascular access is a main concern, as complications substantially contribute to morbidity and mortality. PC-mAb, reduces inflammation by targeting PC (phosphorylcholine), and therefore has the potential to prevent the neointimal hyperplasia that is the root cause of vascular access failure. The fully human 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.

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




Athera completes multiple dosing trial with its fully human antibody PC-mAb
Jun 20, 2017.

Stockholm June 20, 2017 Athera Biotechnologies AB today announced that last dosing in a multiple dosing study in healthy volunteers has been given with its fully human antibody PC-mAb, with continued support for development based on preliminary safety and pharmacokinetics reporting.

“We are very pleased with the progress of this MAD study and that the preliminary data support our plans with once monthly administration over longer time. We are looking forward to the complete results after the follow-up visits” says Carina Schmidt, CEO of Athera. “The study is a preparation for the Phase 2a study that we are planning to submit in the next month.”

The fully human 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.

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




Proteomics used to investigate effects on inflammation response following vascular surgery and treatment with the immunovascular antibody PC-mAb
May 12, 2017.

Stockholm May 12, 2017 Scientists report a proteomic study of systemic inflammation following vascular surgery and treatment with the fully human antibody PC-mAb from Athera at the recent 19th Swedish Cardiovascular Spring meeting. The group of scientists, from Örebro University, Karolinska Institutet and the biotech company Athera, concluded that proteomics can be used to study treatment effects in future studies. The fully human antibody 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.

Revascularization in the legs in patients with severe peripheral arterial disease, PAD, is done to restore blood flow, to reduce pain and restore mobility. However, the risk for amputation of the affected limb is still high, as well as severe events like heart attack and stroke. Open surgery is well known to cause an acute inflammatory reaction lasting for days and weeks, and patients suffer an increased risk for complications during this period, but it is still largely unknown how the surgery affects inflammation mediators. Proteomic analysis in longitudinal samples can give such information, knowledge that could improve risk management in the sub-acute phase following surgery. The patients were participating in a safety study of PC-mAb, a novel fully human therapeutic antibody targeting phosphorylcholine (PC), a key mediator of vascular inflammation. Blood samples were obtained before and at several time points after surgery. A novel multiplex proteomics assay from OLINK was used to determine levels of 251 proteins. As expected, established markers for the acute phase reaction (IL-6 and CRP) were markedly elevated after surgery. Moreover, 65 of 251 proteins measured were significantly increased from baseline to the days after surgery. Only 3 proteins were significantly reduced in the acute phase following surgery and 18 proteins were differentially affected by treatment with PC-mAb. The results are promising and support the use of proteomics analysis to be used to study treatment effects of PC-mAb in future clinical studies.

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




Kontantemission om 18 MSEK genomförd (Swedish only)
Apr 27, 2017.

Den 23 mars 2017 beslutade styrelsen i Athera Biotechnologies AB, med stöd av bemyndigandet från extra bolagsstämma den 19 januari 2017, att genomföra nyemission genom att Bolagets aktiekapital ökas, med företrädesrätt för aktieägare registrerade i aktieboken. Nyemissionen medför att Bolaget tillförts cirka 18,1 MSEK före och efter avdrag för emissionskostnader (0 SEK). Aktierna tecknades av befintliga aktieägare samt nyckelpersoner i teamet.




Kallelse till årsstämma i Athera Biotechnologies AB (Swedish only)
Mar 31, 2017.

Styrelsen i Athera Biotechnologies AB (publ) kallar härmed till årsstämma torsdag den 27:e april 2017 kl 14.00 i bolagets lokaler på S:t Eriksgatan 117 i Stockholm.

Årsstämma i Athera Biotechnologies AB

Deltagande
Rätt att delta på stämman
Aktieägare som önskar delta i årsstämman ska dels vara införd i aktieboken fredag den 21:e april 2017, dels anmäla sin avsikt att delta i årsstämman senast måndag den 24:e april 2017.

Anmälan om deltagande i årsstämman m.m.
Anmälan om deltagande i årsstämman ska ske skriftligen till Athera Biotechnologies AB, Carina Schmidt, S:t Eriksgatan 117, 113 43 Stockholm eller per e-post c.schmidt@athera.se.

Vid anmälan ska uppges aktieägarens namn, personnummer/organisationsnummer, adress och telefonnummer. Dessutom ska vid anmälan anges om aktieägaren ska företrädas av ombud och om aktieägaren ska medföra biträde. Högst 2 biträden får medföras. Aktieägare som företräds genom ombud ska utfärda skriftlig daterad fullmakt för ombudet. Fullmakten bör i god tid före stämman insändas till bolaget på ovanstående adress. Om fullmakten utfärdas av juridisk person som ej är registrerad i det av Bolagsverket förda aktiebolagsregistret, ska bestyrkt kopia av registreringsbevis eller motsvarande för den juridiska personen bifogas. För beställning av fullmaktsformulär gäller samma kontaktuppgifter som för anmälan (se ovan).

Förslag till dagordning

Stämmans öppnande
Val av ordförande vid bolagsstämman.
Upprättande och godkännande av röstlängd.
Val av en eller två justeringsmän att jämte ordföranden underteckna protokollet.
Godkännande av dagordning.
Prövning av om bolagsstämman blivit behörigen sammankallad.
Information från bolagets verkställande direktör.
Framläggande av årsredovisningen och revisionsberättelsen.
Beslut om:
fastställande av resultaträkningen och balansräkningen
dispositioner beträffande aktiebolagets vinst eller förlust enligt den fastställda balansräkningen, och
ansvarsfrihet åt styrelseledamöterna och verkställande direktören.
Val till styrelsen och revisor.
Fastställande av arvoden till styrelsen och revisorn.
Beslut om nyemission av aktier.
Bemyndigande till styrelsen att genomföra nyemission av aktier.
Annat ärende, som skall tas upp på bolagsstämman enligt aktiebolagslagen (2005:551) eller bolagsordningen.
Stämmans avslutande.

Övrigt

Kallelse med styrelsens förslag och handlingar i enlighet med aktiebolagslagen finns tillgängliga hos bolaget på S:t Eriksgatan 117, 113 43 Stockholm senast två veckor innan årsstämman.

Stockholm den 30 mars 2017.
Styrelsen för Athera Biotechnologies AB
S:t Eriksgatan 117, 113 43 Stockholm Org.nr: 556620-6859

Styrelsens säte: Stockholms kommun, Stockholms län




Kontantemission i Athera Biotechnologies AB (Swedish only)
Mar 27, 2017.

Extra bolagsstämman i Athera Biotechnologies AB, beslöt den 19 januari 2017 att bemyndiga styrelsen att anskaffa nytt kapital upp till 20 000 000 kronor genom nyemission, konvertibla lån eller andra finansiella instrument till en kommersiellt rimlig värdering och pris.

Styrelsen i Athera Biotechnologies AB beslöt den 23 mars 2017 att genomföra nyemission genom att Bolagets aktiekapital ökas genom nyemission. Rätt att teckna sig för aktier ska med företrädesrätt tillkomma aktieägare registrerade i aktieboken. Teckning av nya aktier ska ske på separat teckningslista till och med den 6 april 2017.




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