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




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