THE LANCET publishes promising data of APEIRON’s APN01 (rhsACE2) to treat COVID-19 in named patient use

– Case study from promising first COVID-19 patient treatment with APN01 supports APEIRON’s ongoing pivotal Phase II clinical trial

– First data on the effect of blocking the spike protein in COVID-19 patient confirm mode of action of APN01 specifically targeting SARS-CoV-2

Vienna, Austria, 25 September 2020: APEIRON Biologics AG today announced that first, encouraging data with its clinical drug candidate APN01 (rhsACE2) to treat severe COVID-19 were published in the peer-reviewed journal The Lancet Respiratory Medicine ^[1].

The Case Report describes the first treatment of a patient suffering from severe COVID-19 with APN01 in named patient use. The data published show the expected observations of an adaptive immune response, a rapid loss of virus load and reduction in inflammatory mediators, and the development of high titers of neutralizing antibodies against SARS-CoV-2 leading to a significant clinical improvement of the patient treated.

Dr. Alexander Zoufaly, MD, Senior physician at the Department of Infectious Diseases/Clinic Favoriten and author of the publication comments: “ACE2 is at the center of COVID-19 research and drug development. In this instance, we have now provided first data on soluble ACE2 therapy in a patient with SARS-CoV-2 infection. The results from this named patient use are encouraging and support the rationale to further explore APN01 as a therapy to treat COVID-19 in clinical trials.”

“Providing first data on the effect of blocking the viral Spike glycoprotein in patients with COVID-19 is of paramount importance. The data confirm the mode of action of APN01 specifically targeting the SARS-CoV-2 virus,” says Prof. Josef Penninger, MD, co-inventor of APN01, founder of APEIRON Biologics AG, member of its supervisory board, Professor at the University of British Columbia and co-author of the publication. “Our findings from the first SARS epidemic and recent research have identified ACE2 as the entry door for both corona viruses, SARS-CoV and SARS-CoV-2, to infect human cells. The new data further support the ability of APN01 to locking the door for the virus. Importantly, in contrast to basically all other drug candidates, APN01 has a dual action – it blocks the virus and can protect the lung, blood vessels or the heart from injury via its enzyme function. The compassionate use findings provide essential data that this important enzyme function of APN01 is preserved in treated COVID-19 patients.”

Peter Llewellyn-Davies, CEO of APEIRON Biologics AG, adds: “We are delighted our drug candidate APN01 may have helped this patient to overcome the life-threatening disease and are confident to confirm these positive results in our ongoing and progressing pivotal clinical Phase II trial. The further scientific validation by this renowned journal encourages us in our efforts to providing an efficacious therapy against COVID-19 for the benefit of patients and society.”

Key findings of the publication: APN01 (soluble ACE2) infusion showed the expected enzymatic activity and modulation of the renin angiotensin system. The APN01 infusion correlated with a gradual reduction in levels of multiple disease relevant inflammatory mediators over the studied time period. The infusion of APN01 also correlated with a rapid loss of detectable viremia and slightly delayed reduction in viral titers in tracheal samples and nasopharyngeal swaps. APN01 infusion was fully compatible with an adaptive immune response and the development of high titers of neutralizing antibodies against SARS-CoV-2.

About APN01 / alunacedase alfa (soluble ACE2)

APN01 / alunacedase alfa (rhsACE2) is a well-advanced drug candidate for the treatment of COVID-19 and one of the few therapeutic approaches specifically directed against the corona virus. According to experts, if the current Phase II study is positive, accelerated market approval could probably take place.

The company-sponsored Phase II trial is ongoing in Austria, Germany, Denmark, UK, and Russia and is expected to be expanded to the US. The double-blind, randomized, placebo-controlled study aims to treat 200 patients with severe COVID-19 disease.

The specific targeting of SARS-CoV-2 by APN01 was recently confirmed by preclinical results published in the peer-reviewed publication CELL ^[2].

About APEIRON Biologics AG

APEIRON Biologics AG is a European private biotechnology company based in Vienna, Austria, that specializes in the discovery, development and commercialization of novel immunotherapies for cancer and respiratory diseases. APEIRON’s APN01 / alunacedase alfa (rhsACE2) is undergoing a Phase II trial to treat COVID-19. APEIRON has an approved product on the market, Qarziba(R), for the treatment of pediatric neuroblastoma patients, which is distributed by EUSA Pharma. The company’s clinical program APN401 is a first-in-class autologous cellular therapy to strengthen immune reactivity via targeting the intracellular master checkpoint, Cbl-b. APEIRON’s projects and technologies are based on a strong patent portfolio and partnerships with leading pharmaceutical companies and academic institutions. Further information at www.apeiron-biologics.com

For further information, please contact:

APEIRON Biologics AG
Peter Llewellyn-Davies, CEO
Email: investors@apeiron-biologics.com
www.apeiron-biologics.com

Media and Investor Relations
MC Services AG
Julia Hofmann
T +49 89 210 228 0
Email: apeiron@mc-services.eu

FORWARD-LOOKING STATEMENTS
This press release contains certain forward-looking statements that involve risks and uncertainties. These statements reflect APEIRON’s opinion at the time of this press release. Such forward-looking statements are neither promises nor guarantees, but depend on many risks and uncertainties, many of which are beyond the control of APEIRON’s management. This could cause actual results to differ materially from those projected in these forward-looking statements. We expressly assume no obligation to publicly update or revise any forward-looking statements regarding changed expectations of the parties or regarding new events, conditions or circumstances on which these statements are based.

^[1]Zoufaly A. et al., The Lancet Respiratory Medicine, 2020, S2213-2600(20)30418-5 DOI: https://doi.org/10.1016/S2213-2600(20)30418-5
^[2]Monteil V. et. al., Cell, 2020, 181(14);905-913.e7 DOI: https://doi.org/10.1016/j.cell.2020.04.004

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Corporate News

Bad Neustadt a. d. Saale | 25th September 2020

RHÖN-KLINIKUM AG sells shares in Medgate Deutschland GmbH

RHÖN-KLINIKUM AG has transferred 51% of its shares in Medgate Deutschland GmbH to its
co-shareholder, Medgate Holding AG. Both contracting parties agree that telemedicine will form an indispensable component of medical care in future and will be a useful addition to inpatient and outpatient care from both a medical and economic perspective. At the same time, the shareholders of Medgate Deutschland GmbH have also agreed that such fundamental cooperation is not dependent on the rigid boundaries of a legal entity. As a result, Medgate Deutschland GmbH in future will exclusively belong to the Medgate Holding AG group.

RHÖN-KLINIKUM AG will continue its active commitment in the area of telemedicine. Here RHÖN-KLINIKUM AG, in addition to other cooperation schemes already existing, will also explore potential cooperation opportunities with the corporate group of Asklepios Kliniken GmbH & Co. KGaA.

RHÖN-KLINIKUM AG is one of the largest healthcare providers in Germany. We offer excellent medical care with a direct tie-in to universities and research facilities. We treat over 860,000 patients every year at our five locations of Zentralklinik Bad Berka, Campus Bad Neustadt, Klinikum Frankfurt (Oder), Universitätsklinikum Gießen and Universitätsklinikum Marburg (UKGM), and employ more than 18,000 persons. The innovative RHÖN Campus approach for cross-sector and future-oriented healthcare delivery in rural areas, the steadfast continuation of gradual digital transformation within the Company as well as use of telemedicine are important elements of our corporate strategy. RHÖN-KLINIKUM AG is an independent Company operating under the umbrella of Asklepios Kliniken GmbH & Co. KGaA.

Further information can be found on the Internet at www.rhoen-klinikum-ag.com

Follow us on:

www.twitter.com/rhoenklinikumag
www.xing.com/companies/rhön-klinikumag
www.youtube.com/rhönklinikumag

RHÖN-Gesundheitsblog (health blog):

https://www.rhoen-gesundheitsblog.de/

Contact:

RHÖN-KLINIKUM AG | Head of Division Corporate Communications and Marketing
Elke Pfeifer
T. +49 9771 65-12110 | elke.pfeifer@rhoen-klinikum-ag.com

RHÖN-KLINIKUM AG | Head of Investor Relations and Treasury
Julian Schmitt
T. +49 9771 65-12250 | julian.schmitt@rhoen-klinikum-ag.com

RHÖN-KLINIKUM AG | Schlossplatz 1 | D-97616 Bad Neustadt a. d. Saale

Medgate

Medgate focuses on digital healthcare solutions to bring the physician to where he or she is needed by patients. Emphasis is also placed on the well-being of patients as well as on the benefit for society in general. Medgate was established in 1999 and currently employs over 510 employees worldwide. Since 2000, Medgate has been operating the largest telemedical centre in Europe. Medgate therefore possesses a large amount of experience and knowledge in the field of telemedicine. Medgate is also present in the Philippines, the United Arab Emirates and India. www.medgate.care

Contact:

Cédric Berset, Director Marketing, Communications & Sales
Medgate, Postfach, 4020 Basel
Mobile +41 79 455 20 41 | media@medgate.ch

Abivax presents first-half 2020 financial results and operations update

• ABX464 Phase 2a ulcerative colitis two-year maintenance study results confirm good safety profile and durable efficacy of 50 mg once-daily oral ABX464
• 77% (180/232) of patients randomized in ABX464 Phase 2b ulcerative colitis study, recruitment expected to be completed by the end of 2020
• ABX464 pivotal Phase 2b/3 trial for Crohn’s disease planned with anticipated start of patient recruitment in Q1 2021
• ABX464 Phase 2b/3 Covid-19 study, ABX464 Phase 2a rheumatoid arthritis study and ABX196 Phase 1/2 hepatocellular carcinoma trial all making progress
• Cash for operations until beginning 2021, with major financing secured through non-dilutive funding from Bpifrance (EUR 36m) and a state-guaranteed loan from Société Générale (EUR 5m)

PARIS, France, September 24, 2020 – 08:00 p.m. (CET) – Abivax (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, today announces its 2020 half-year financial results, as of June 30, 2020, and provides an update on its pipeline progress. The financial statements for the first half of 2020, approved by the Company’s Board of Directors on September 22, 2020, have been audited and the certification report is being prepared by the Company’s external auditors.

Prof. Hartmut Ehrlich, M.D., CEO of Abivax said: “Abivax has made tremendous progress in its ongoing clinical programs despite the Covid-19 pandemic, and the recruitment pace is now back on a pre-Covid-19 level. This is particularly important for Abivax’s priority clinical program, the ABX464 Phase 2b trial in ulcerative colitis, conducted in 15 European countries as well as the US and Canada, with 77% of patients already randomized to date. We expect recruitment in this trial to be completed by the end of this year and to report top-line results in early Q2 2021. Given the fast enrollment, KOL and investigators’ commitment, and high patient retention rate, we are confident that the outcome of this study will confirm the very promising two-year Phase 2a maintenance data that we announced at the beginning of September. Additionally, we were able to efficiently set up the miR-AGE trial to test the potentially beneficial triple effect of ABX464 for the treatment of high-risk Covid-19 patients. The trial is ongoing in six European countries and Brazil, and we expect to open centers in Mexico, Chile and Peru shortly. As always, our strategic decisions are driven by value generation for our shareholders as well as the ability to broadly and rapidly provide access to ABX464 for patients in need and partnering remains the Company’s preferred scenario.”

Didier Blondel, CFO of Abivax, added: “The past months have been particularly eventful for Abivax and opened up several new opportunities. Due to the unique properties of ABX464 which has both an antiviral and anti-inflammatory effects, we expanded our clinical pipeline to treat high-risk Covid-19 patients to prevent the development of life-threatening hyperinflammation and the resulting potentially fatal acute respiratory distress syndrome. We are grateful that the French government (Bpifrance and CGI) actively support the miR-AGE trial as well as the future development and required next steps for the potential commercialization of ABX464. The EUR 36 million in funding provided by Bpifrance was complemented by an additional EUR 5 million from Société Générale; taken together with our current cash resources, of EUR 12.1m as of June 30, 2020, we have sufficient funding for operations until early 2021. With the continued trust and financial support of our stakeholders and the French government, we are in a good position to select, in the near term, the most attractive opportunities for Abivax shareholders and patients in need of innovative Abivax products.”

FIRST HALF 2020 FINANCIAL HIGHLIGHTS

* Excluding items of the liquidity contract (liquidity and own shares) and deposits & guarantees
 

• Operating loss EUR -14.6m (EUR 2.6m compared to EUR -17.2m as of June 30, 2019) due to retained investments in R&D (EUR 1.5m).
• Total number of employees at the end of June 2020 steady at 26.
• R&D expenses decreased to EUR -13.5m (EUR 1.5m compared to EUR -15.0m as of June 30, 2019), mainly due to the consequences of the Covid-19 pandemic and the lockdown of the research laboratories. R&D funding was focused on the development of ABX464 in inflammatory indications (92% of the total R&D expenses).
• G&A expenses were at EUR 2.8m as of June 30, 2020 (17% of total operating costs) compared to EUR 2.3m (13%) as of June 30, 2019.
• Revenues of EUR 1.6m are relating to the grant component of the first milestone payment of Covid-19 Bpifrance funding agreement.
• 2020 Research Tax Credit should be limited, due to 2020 Covid-19 Bpifrance funding milestone payments, reducing the eligible R&D spending basis. Therefore, no revenue accrual has been recorded as of June 30, 2020 end, contrary to June 2019 (EUR 3.8m).
• Cash at the end of June 2020 was EUR 12.1m, compared to EUR 9.8m at the end of 2019.
• Company is currently funded until early 2021, based on the following assumptions:
  • the assessment of planned increasing R&D needs
  • the exercise of the remaining equity line with Kepler Cheuvreux for EUR 11m (EUR 20 Abivax share price assumption)
  • the 2020 cash in resulting from the second milestone payment of Covid-19 Bpifrance funding of EUR 7.9m before year-end

OPERATING HIGHLIGHTS: PORTFOLIO UPDATE

ABX464 in ulcerative colitis (UC)
After the promising results obtained during the Phase 2a 12-month-open-label extension study, Abivax recently reported excellent two-year efficacy and safety data for ABX464 ulcerative colitis Phase 2a maintenance study. These results once again confirmed the good safety profile and durable efficacy of 50 mg once-daily oral ABX464 in patients with moderate-to-severe UC after the second year of treatment, with 69% of patients in clinical remission and 94% benefiting from a clinical response. Furthermore, readings of the endoscopies were performed centrally by independent reviewers and median fecal calprotectin, the key biological marker of UC disease activity, remained at 31.6 µg/g (normal levels are below 50 µg/g).

For the currently ongoing UC Phase 2b trial, ABX464-103, patient enrollment is ongoing and on track in all 15 European countries, as well as in Canada and the US where patients have been included into the study. 77% (180/232) of patients have been randomized to date and recruitment is anticipated to be completed by the end of 2020. Top-line results of the two-month induction study are expected for Q2 2021. Abivax is currently preparing all required steps to advance ABX464 for the treatment of moderate-to-severe UC into a Phase 3 clinical program.

With its persistent good clinical safety and tolerability profile along with its durable superior efficacy, Abivax is very confident that ABX464 can become a potent chronic therapy option to address the high unmet medical need in UC and potentially additional inflammatory diseases.

ABX464 in Crohn’s disease (CD)
Abivax decided to follow the latest recommendations of its leading KOLs and is now planning to go straight into a pivotal Phase 2b/3 trial in CD. Due to the pathophysiological and clinical similarities of CD and UC, Abivax is keen to investigate if the pivotal study in CD will demonstrate strong efficacy and favorable safety as already reported in UC. The clinical study in CD is expected to start patient recruitment beginning of 2021.

ABX464 in Covid-19 – miR-AGE trial
In May, Abivax announced the launch of a randomized, double-blind, placebo-controlled Phase 2b/3 trial of ABX464 in 1,034 Covid-19 elderly or high-risk patients (miR-AGE trial – ABX464-401). In June, the miR-AGE trial was selected by the French Government as one of six research projects to find a therapeutic solution to treat Covid-19 patients. These projects are financed with a total of EUR 78m by the French state, of which Abivax receives 36m EUR in non-dilutive funding for the conduct of the trial as well as for manufacturing scale-up and additional development costs related to other ABX464 studies for the potential filing of Marketing Authorization Applications (MAAs).

The miR-AGE trial is currently ongoing in France, Italy, Spain, Germany, Belgium and the UK as well as in Brazil. Patient recruitment in Mexico is imminent, as are regulatory approvals to initiate the study in Peru and Chile. Abivax will perform an interim analysis after the treatment of 300 patients and, subject to the evolution of the pandemic, plans to complete recruitment in Q4 2020.

The decision to expand Abivax’s clinical pipeline with a Covid-19 indication was based on the potentially beneficial triple effect of ABX464 for the treatment of elderly and high-risk patients, including: 1) antiviral effect to inhibit SARS-CoV-2 replication, demonstrated in an in vitro stringent human pulmonary epithelium model; 2) anti-inflammatory effect to prevent hyper-inflammation, shown in a Phase 2a clinical trial in UC patients with once-daily oral administration of ABX464; and 3) tissue repair properties that might limit longer-term pulmonary damage as observed for the healing of inflammatory lesions in UC patients. With its unique molecular mechanism of action, and convenient oral dosing, ABX464 has the potential to prevent and treat cytokine storm and hyper-inflammation, which lead to acute respiratory distress syndrome (ARDS) and death of Covid-19 patients.

Other clinical programs:

ABX464 in rheumatoid arthritis (RA)
The ongoing ABX464-301 Phase 2a study is designed to evaluate the safety, tolerability and preliminary efficacy of two oral dose-levels of ABX464 administered daily, in combination with methotrexate (MTX), in patients with moderate-to-severe active RA who had an inadequate response to MTX and/or to one or more anti-tumor necrosis factor alpha (TNFα) biological therapeutics. The trial is ongoing in 24 study centers across Europe and the completion of enrollment of 60 patients is expected for the end of this year.

ABX196 in hepatocellular carcinoma (HCC)
In the Phase 1/2 clinical trial ongoing at the Scripps MD Anderson Cancer Center in San Diego and the MD Anderson Cancer Center in Houston, HCC patients are treated with ABX196 in combination with the checkpoint inhibitor nivolumab (Opdivo(R), Bristol Myers Squibb). Up to 46 patients will be included into this clinical study that consists of two phases, a dose escalation phase and an expansion phase. Top-line data from the dose escalation phase are expected at the end of this year.

Financial Calendar 2020

• Wednesday September 30, 2020
  Publication and release of 2020 Half Year Report

About Abivax (www.abivax.com)
Abivax, a clinical stage biotechnology company, is mobilizing the body’s natural immune machinery to treat patients with autoimmune diseases, viral infections, and cancer. Abivax is listed on Euronext compartment C (ISIN: FR0012333284 – Mnémo: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 to treat severe inflammatory diseases, and ABX196 to treat hepatocellular carcinoma.

More information on the company is available at www.abivax.com. Follow us on Twitter @ABIVAX_.

Contacts

DISCLAIMER

This press release contains forward-looking statements, forecasts and estimates (including patient recruitment) with respect to certain of the Company’s programs. Although the Company believes that its forward-looking statements, forecasts and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors that have been deemed reasonable, such forward-looking statements, forecasts and estimates are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in such forward-looking statements, forecasts and estimates. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its registration document (Document de Référence). Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law.
This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction, in particular in France. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgement. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

Abivax presents first-half 2020 financial results and operations update

• ABX464 Phase 2a ulcerative colitis two-year maintenance study results confirm good safety profile and durable efficacy of 50 mg once-daily oral ABX464
• 77% (180/232) of patients randomized in ABX464 Phase 2b ulcerative colitis study, recruitment expected to be completed by the end of 2020
• ABX464 pivotal Phase 2b/3 trial for Crohn’s disease planned with anticipated start of patient recruitment in Q1 2021
• ABX464 Phase 2b/3 Covid-19 study, ABX464 Phase 2a rheumatoid arthritis study and ABX196 Phase 1/2 hepatocellular carcinoma trial all making progress
• Cash for operations until beginning 2021, with major financing secured through non-dilutive funding from Bpifrance (EUR 36m) and a state-guaranteed loan from Société Générale (EUR 5m)

PARIS, France, September 24, 2020 – 08:00 p.m. (CET) – Abivax (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, today announces its 2020 half-year financial results, as of June 30, 2020, and provides an update on its pipeline progress. The financial statements for the first half of 2020, approved by the Company’s Board of Directors on September 22, 2020, have been audited and the certification report is being prepared by the Company’s external auditors.

Prof. Hartmut Ehrlich, M.D., CEO of Abivax said: “Abivax has made tremendous progress in its ongoing clinical programs despite the Covid-19 pandemic, and the recruitment pace is now back on a pre-Covid-19 level. This is particularly important for Abivax’s priority clinical program, the ABX464 Phase 2b trial in ulcerative colitis, conducted in 15 European countries as well as the US and Canada, with 77% of patients already randomized to date. We expect recruitment in this trial to be completed by the end of this year and to report top-line results in early Q2 2021. Given the fast enrollment, KOL and investigators’ commitment, and high patient retention rate, we are confident that the outcome of this study will confirm the very promising two-year Phase 2a maintenance data that we announced at the beginning of September. Additionally, we were able to efficiently set up the miR-AGE trial to test the potentially beneficial triple effect of ABX464 for the treatment of high-risk Covid-19 patients. The trial is ongoing in six European countries and Brazil, and we expect to open centers in Mexico, Chile and Peru shortly. As always, our strategic decisions are driven by value generation for our shareholders as well as the ability to broadly and rapidly provide access to ABX464 for patients in need and partnering remains the Company’s preferred scenario.”

Didier Blondel, CFO of Abivax, added: “The past months have been particularly eventful for Abivax and opened up several new opportunities. Due to the unique properties of ABX464 which has both an antiviral and anti-inflammatory effects, we expanded our clinical pipeline to treat high-risk Covid-19 patients to prevent the development of life-threatening hyperinflammation and the resulting potentially fatal acute respiratory distress syndrome. We are grateful that the French government (Bpifrance and CGI) actively support the miR-AGE trial as well as the future development and required next steps for the potential commercialization of ABX464. The EUR 36 million in funding provided by Bpifrance was complemented by an additional EUR 5 million from Société Générale; taken together with our current cash resources, of EUR 12.1m as of June 30, 2020, we have sufficient funding for operations until early 2021. With the continued trust and financial support of our stakeholders and the French government, we are in a good position to select, in the near term, the most attractive opportunities for Abivax shareholders and patients in need of innovative Abivax products.”

FIRST HALF 2020 FINANCIAL HIGHLIGHTS

* Excluding items of the liquidity contract (liquidity and own shares) and deposits & guarantees
 

• Operating loss EUR -14.6m (EUR 2.6m compared to EUR -17.2m as of June 30, 2019) due to retained investments in R&D (EUR 1.5m).
• Total number of employees at the end of June 2020 steady at 26.
• R&D expenses decreased to EUR -13.5m (EUR 1.5m compared to EUR -15.0m as of June 30, 2019), mainly due to the consequences of the Covid-19 pandemic and the lockdown of the research laboratories. R&D funding was focused on the development of ABX464 in inflammatory indications (92% of the total R&D expenses).
• G&A expenses were at EUR 2.8m as of June 30, 2020 (17% of total operating costs) compared to EUR 2.3m (13%) as of June 30, 2019.
• Revenues of EUR 1.6m are relating to the grant component of the first milestone payment of Covid-19 Bpifrance funding agreement.
• 2020 Research Tax Credit should be limited, due to 2020 Covid-19 Bpifrance funding milestone payments, reducing the eligible R&D spending basis. Therefore, no revenue accrual has been recorded as of June 30, 2020 end, contrary to June 2019 (EUR 3.8m).
• Cash at the end of June 2020 was EUR 12.1m, compared to EUR 9.8m at the end of 2019.
• Company is currently funded until early 2021, based on the following assumptions:
  • the assessment of planned increasing R&D needs
  • the exercise of the remaining equity line with Kepler Cheuvreux for EUR 11m (EUR 20 Abivax share price assumption)
  • the 2020 cash in resulting from the second milestone payment of Covid-19 Bpifrance funding of EUR 7.9m before year-end

OPERATING HIGHLIGHTS: PORTFOLIO UPDATE

ABX464 in ulcerative colitis (UC)
After the promising results obtained during the Phase 2a 12-month-open-label extension study, Abivax recently reported excellent two-year efficacy and safety data for ABX464 ulcerative colitis Phase 2a maintenance study. These results once again confirmed the good safety profile and durable efficacy of 50 mg once-daily oral ABX464 in patients with moderate-to-severe UC after the second year of treatment, with 69% of patients in clinical remission and 94% benefiting from a clinical response. Furthermore, readings of the endoscopies were performed centrally by independent reviewers and median fecal calprotectin, the key biological marker of UC disease activity, remained at 31.6 µg/g (normal levels are below 50 µg/g).

For the currently ongoing UC Phase 2b trial, ABX464-103, patient enrollment is ongoing and on track in all 15 European countries, as well as in Canada and the US where patients have been included into the study. 77% (180/232) of patients have been randomized to date and recruitment is anticipated to be completed by the end of 2020. Top-line results of the two-month induction study are expected for Q2 2021. Abivax is currently preparing all required steps to advance ABX464 for the treatment of moderate-to-severe UC into a Phase 3 clinical program.

With its persistent good clinical safety and tolerability profile along with its durable superior efficacy, Abivax is very confident that ABX464 can become a potent chronic therapy option to address the high unmet medical need in UC and potentially additional inflammatory diseases.

ABX464 in Crohn’s disease (CD)
Abivax decided to follow the latest recommendations of its leading KOLs and is now planning to go straight into a pivotal Phase 2b/3 trial in CD. Due to the pathophysiological and clinical similarities of CD and UC, Abivax is keen to investigate if the pivotal study in CD will demonstrate strong efficacy and favorable safety as already reported in UC. The clinical study in CD is expected to start patient recruitment beginning of 2021.

ABX464 in Covid-19 – miR-AGE trial
In May, Abivax announced the launch of a randomized, double-blind, placebo-controlled Phase 2b/3 trial of ABX464 in 1,034 Covid-19 elderly or high-risk patients (miR-AGE trial – ABX464-401). In June, the miR-AGE trial was selected by the French Government as one of six research projects to find a therapeutic solution to treat Covid-19 patients. These projects are financed with a total of EUR 78m by the French state, of which Abivax receives 36m EUR in non-dilutive funding for the conduct of the trial as well as for manufacturing scale-up and additional development costs related to other ABX464 studies for the potential filing of Marketing Authorization Applications (MAAs).

The miR-AGE trial is currently ongoing in France, Italy, Spain, Germany, Belgium and the UK as well as in Brazil. Patient recruitment in Mexico is imminent, as are regulatory approvals to initiate the study in Peru and Chile. Abivax will perform an interim analysis after the treatment of 300 patients and, subject to the evolution of the pandemic, plans to complete recruitment in Q4 2020.

The decision to expand Abivax’s clinical pipeline with a Covid-19 indication was based on the potentially beneficial triple effect of ABX464 for the treatment of elderly and high-risk patients, including: 1) antiviral effect to inhibit SARS-CoV-2 replication, demonstrated in an in vitro stringent human pulmonary epithelium model; 2) anti-inflammatory effect to prevent hyper-inflammation, shown in a Phase 2a clinical trial in UC patients with once-daily oral administration of ABX464; and 3) tissue repair properties that might limit longer-term pulmonary damage as observed for the healing of inflammatory lesions in UC patients. With its unique molecular mechanism of action, and convenient oral dosing, ABX464 has the potential to prevent and treat cytokine storm and hyper-inflammation, which lead to acute respiratory distress syndrome (ARDS) and death of Covid-19 patients.

Other clinical programs:

ABX464 in rheumatoid arthritis (RA)
The ongoing ABX464-301 Phase 2a study is designed to evaluate the safety, tolerability and preliminary efficacy of two oral dose-levels of ABX464 administered daily, in combination with methotrexate (MTX), in patients with moderate-to-severe active RA who had an inadequate response to MTX and/or to one or more anti-tumor necrosis factor alpha (TNFα) biological therapeutics. The trial is ongoing in 24 study centers across Europe and the completion of enrollment of 60 patients is expected for the end of this year.

ABX196 in hepatocellular carcinoma (HCC)
In the Phase 1/2 clinical trial ongoing at the Scripps MD Anderson Cancer Center in San Diego and the MD Anderson Cancer Center in Houston, HCC patients are treated with ABX196 in combination with the checkpoint inhibitor nivolumab (Opdivo(R), Bristol Myers Squibb). Up to 46 patients will be included into this clinical study that consists of two phases, a dose escalation phase and an expansion phase. Top-line data from the dose escalation phase are expected at the end of this year.

Financial Calendar 2020

• Wednesday September 30, 2020
  Publication and release of 2020 Half Year Report

About Abivax (www.abivax.com)
Abivax, a clinical stage biotechnology company, is mobilizing the body’s natural immune machinery to treat patients with autoimmune diseases, viral infections, and cancer. Abivax is listed on Euronext compartment C (ISIN: FR0012333284 – Mnémo: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 to treat severe inflammatory diseases, and ABX196 to treat hepatocellular carcinoma.

More information on the company is available at www.abivax.com. Follow us on Twitter @ABIVAX_.

Contacts

DISCLAIMER

This press release contains forward-looking statements, forecasts and estimates (including patient recruitment) with respect to certain of the Company’s programs. Although the Company believes that its forward-looking statements, forecasts and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors that have been deemed reasonable, such forward-looking statements, forecasts and estimates are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in such forward-looking statements, forecasts and estimates. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its registration document (Document de Référence). Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law.
This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction, in particular in France. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgement. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

Relief partner NeuroRx submits request for Emergency Use Authorization for RLF-100(TM) (aviptadil) in the treatment of patients with Critical COVID-19 and Respiratory Failure who have exhausted approved therapy

Emergency Use Authorization request targets the same population as is currently permitted under FDA Expanded Access Protocol

Geneva, Switzerland, and Radnor, PA, September 23, 2020 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief” or the “Company“) and NeuroRx, Inc. today announce that NeuroRx, Inc. has submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100(TM) aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments. RLF-100 is being developed by NeuroRx as part of a global partnership with Relief. The submission is based on a case-control study that compared patients who were treated with RLF-100(TM) (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff. Patients treated with RLF-100(TM) demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement. Hypotension was seen in two aviptadil patients and was successfully managed with pressors. Diarrhea was seen in 4/21 aviptadil-treated patients and 3/30 control patients. The results have been submitted to a peer-reviewed journal.

“The EUA application covers the same type of patients whom FDA has already allowed to receive treatment under the Expanded Access protocol authorized by the Agency in July. Tragically, we have found that many patients who might benefit from the Expanded Access protocol are hospitalized in centers that do not allow patients access to investigational drugs,” said Jonathan Javitt, MD, MPH, Chairman and CEO of NeuroRx, “Our staff is working around the clock to address requests for RLF-100(TM) under the appropriate mechanism. All too often, patients of color and those of lower socioeconomic status are denied access.”

FDA’s guidance to industry identifies the criteria for EUA as safe and “may be effective,” in contrast to the far more stringent requirement of “safe and effective” required for traditional drug approval. EUA may only be granted in circumstances where the Secretary of Health and Human Services has declared a Public Health Emergency, as is true in the COVID-19 pandemic.

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, said: “We continue to work tirelessly with our partner NeuroRx to bring this potentially life-saving drug to patients afflicted with severe complications of COVID-19 infection as quickly as possible. The pursuit of EUA status is a crucial component of this effort.”

About VIP in Lung Injury
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type 2 cell, which is critical to the transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.

COVID-19-related death is primarily caused by Respiratory Failure. Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells. These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the route of entry for the SARS-CoV-2 into the cells. Coronaviruses are shown to replicate in alveolar type 2 cells, but not in the more numerous type 1 cells. These same type 2 alveolar cells have high concentrations of VIP receptors on their cell surfaces giving rise to the hypothesis that VIP could specifically protect these cells from injury.

Injury to the type 2 alveolar cells is an increasingly plausible mechanism of COVID-19 disease progression. (Mason 2020). These specialized cells replenish the more common type 1 cells that line the lungs. More importantly, type 2 cells manufacture surfactant that coats the lung and is essential for oxygen exchange. Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.

About RLF-100
RLF-100 (Aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Dr. Said’s original work at Stony Brook University, for which Stony Brook was awarded an FDA Orphan Drug Designation in 2001. VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant. FDA has now granted IND authorization for intravenous and inhaled delivery of RLF-100 for the treatment of COVID-19 and awarded Fast Track designation. RLF-100 is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Since July 2020, severe COVID-19 patients have been treated with RLF-100 under U.S. FDA Emergency Use Investigational New Drug (IND) authorization for treatment of individual patients, and an Expanded Access Protocol IND authorization for the treatment of respiratory failure in COVID-19.

About RELIEF THERAPEUTICS Holding SA
Relief focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Relief holds orphan drug designations from the U.S. FDA and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a patent issued in the U.S. and multiple other countries covering potential formulations of RLF-100.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF.

About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug development experience and is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca, PPD. In addition to its work on RLF-100, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. Javitt, MD, MPH, who has served as a health advisor to four Presidential administrations and worked on paradigm-changing drug development projects for Merck, Allergan, Pharmacia, Pfizer, Novartis, and Mannkind, together with Robert Besthof, MIM, who served as the Global Vice President (Commercial) for Pfizer’s Neuroscience and Pain Division. Its Board of Directors and Advisors includes Hon. Sherry Glied, former Assistant Secretary, U.S. Dept. of Health and Human Services; Mr. Chaim Hurvitz, former President of the Teva International Group, Lt. Gen. HR McMaster, the 23rd National Security Advisor, Wayne Pines, former Associate Commissioner of the U.S. Food and Drug Administration, Judge Abraham Sofaer, and Daniel Troy, former Chief Counsel, U.S. Food and Drug Administration.

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG and/or NeuroRx, Inc. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

CORPORATE CONTACTS
RELIEF THERAPEUTICS Holding SA
Raghuram (Ram) Selvaraju, Ph.D., MBA
Chairman of the Board
contact@relieftherapeutics.com

NeuroRx, Inc.
Jonathan C. Javitt, M.D., MPH
Chief Executive Officer
NeuroRx, Inc.
ceo@neurorxpharma.com

MEDIA CONTACT
Relief (Europe):
Anne Hennecke / Brittney Sojeva
MC Services AG
relief@mc-services.eu
+49 (0) 211-529-252-14

NeuroRx (United States):
David Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310

INVESTOR RELATIONS
Relief (Europe):
Anne Hennecke / Brittney Sojeva
MC Services AG
relief@mc-services.eu
+49 (0) 211-529-252-14

NeuroRx (United States):
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122

Press Release // September 23, 2020

Formycon Announces Half-Year Results for 2020

– Group turnover of Euro 16.5 million corresponds to forecasts

– EBITDA of Euro -0.9 million and half-year result of Euro -1.35 million in line with expectations

– Significant progress in late-stage projects, the expansion and further development of the company’s own pipeline and in organizational development

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its financial results for the first half of 2020.

On the day of reporting, June 30, 2020, the Formycon Group’s commercial figures developed as forecasted. The Group’s turnover which, in addition to the joint-stock company also includes the two fully consolidated subsidiaries Formycon Project 201 GmbH and Formycon Project 203 GmbH, as well as the shareholding in FYB 202 GmbH & Co. KG, which is not consolidated, totaled Euro 16.5 million in the first six month of 2020 (H1/2019: Euro 17.2 million).

During the company’s current phase, the Formycon Group continues to focus on research and development activities for its own and out-licensed biosimilar projects as well as its own COVID-19 project. The development services for the out-licensed or partnered projects are also the source of the current revenue returns. Following the successful approval of these products, Formycon also participates in the subsequent marketing revenues.

Consolidated earnings before interest, tax, depreciation and amortization (EBITDA) amounted to Euro
-0.9 million (H1/2019: Euro -0.2 million), the operating result (EBIT) totaled around Euro -1.4 million (H1/2019: Euro -0.7 million). As of June 30, 2020, the Group period result was Euro -1.4 million compared to Euro -0.7 million in the same period last year.

For the full year 2020, Formycon expects revenues at the group level to be between EUR 35 and 40 million. As in previous years, the Group’s financial position is solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 20.2 million on the day of reporting. Including short-term receivables and other assets worth Euro 6.0 million, the Formycon Group held liquid assets of around Euro 26.2 million in total.

Formycon AG, as the company’s central development and operational unit, achieved a turnover of Euro 12.0 million during the first half of 2020 (H1/2019: Euro 11.3 million). The earnings for this period totaled Euro -1.3 million (H1/2019: Euro -0.7 million).

“The half-year figures are in line with our expectations. We have made good progress in the out-licensed and partnered projects. At the same time, we are working intensively on building and developing our own pipeline and are convinced that we will create sustainable value. In addition, we are investing in organizational development, which includes expanding our capacities as well as extensive measures to further digitalize our processes,” comments Dr. Nicolas Combé, CFO of Formycon AG.

The full half-year report can be found on the Internet at
https://www.formycon.com/en/investor-relations/financial-reports/

About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of antibody-based COVID-19 compounds.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. While the global market for biosimilars is currently more than USD 5.0 billion, industry experts expect this figure to grow up to USD 30 billion by the year 2025.

Contact:
Sabrina Müller
Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 – 86 46 67 149
fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

MagForce AG Publishes Shareholder Letter

• Europe: Continued significantly increased numbers of brain tumor treatments
• USA: Treatments of patients in current stage of the prostate cancer trial with streamlined protocol so far show only minimal treatment-related side effects

Berlin, Germany, and Nevada, USA, September 21, 2020 – MagForce AG (Frankfurt, Scale, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, today published a Shareholder Letter:

“Dear MagForce Shareholders,

I am very pleased to update you on the progress we have made with our transformative NanoTherm therapy system as a treatment option for solid tumors. Although the COVID-19 pandemic has developed into a very serious global healthcare challenge with extreme economic and personal restricitons, MagForce is coping with the evolving situation and we continue to have very good prospects for 2020. Our utmost priority in this pandemic remains the safety of our employees, patients and physicians in the clinics as well as partners. We are still happy to say that MagForce’s production has barely been affected. Our expert team is diligently working to bring our therapeutic system to cancer patients worldwide.

MagForce AG – Europe – Brain Cancer Treatment:

Despite the challenging COVID-19 situation, our commercial team was able to turn the corner on commercial revenues and I am very proud to inform you that this has now been impressively reflected in treatment figures. We have won partner clinics that are convinced of our technology and use it with great commitment. We see that this trend is so far sustainable and more and more patients, who often do not have time to spare, have access to our innovative brain tumor treatment option.

Last year, we entered into a cooperation agreement with the Paracelsus Clinic Zwickau. Prof. Dr. med. Habil. Jan-Peter Warnke, Head of Department in the Neurosurgical Clinic at Paracelsus Clinic, and his team have treated brain tumor patients in our new mobile therapy center since December 2019 and offer our potential life-prolonging therapy in the acute interest of patients in Eastern Germany with increasing treatment numbers reported eversince. At the end of September, Paracelsus Clinic Zwickau, with support from the German Brain Tumor Association and the Cancer Society Saxony, will host a patient event which offers the chance to visit the mobile treatment center, as well as provide information on glioblastoma and potential treatment options for patients in Zwickau and the surrounding region.

We already announced that the Hufeland Clinic at the Mühlhausen site in Thuringia will be the next clinic in Europe to offer MagForce’s NanoTherm therapy system for the commercial treatment of brain tumors. Currently construction is ongoing on the station that will be integrated into the neurosurgical department. Most importantly, the center will have its own entrance, which is crucial as brain tumor patients require facilities that are easily accessible. Furthermore, this integrated treatment center provides even more protection in the current pandemic as it will help limit unnecessary contact to persons not directly involved in the treatment process. Final inspections are planned to take place in October with the center opening for patients immediately thereafter. The new treatment center is managed by Privatdozent (PD) Dr. Johannes Wölfer, head physician of the Department of Neurosurgery and Spinal Surgery.

As a long-standing expert in the use of MagForce’s NanoTherm therapy system, PD Dr. Wölfer was also involved in the development of the training concept for the “NanoTherm Therapy School,” together with two further renowned medical opinion leaders: Prof. Dr. Walter Stummer and PD Dr. Dr. Oliver Grauer both at the University Hospital Münster. At the “NanoTherm Therapy School,” surgeons are certified in the use of the innovative technology by participating in a comprehensive series of application training courses. Two sessions have already taken place and on October 9th the next module will be hosted to acquaint surgeons from various clinics in Germany with this new treatment method in a stress-free yet largely realistic setting. This is key to ensuring that patients receive the highest quality of treatment.

However, our expansion activities, including NanoActivator installations in Spain and Italy with partner hospitals, which were planned for the second half of 2020, are delayed due to the enormous challenges in these countries caused by COVID-19 and the travel restrictions. We continue to see interest from other European countries and will proceed with on our European roll-out path in the months to come. With that said, we plan to open at least one additional NanoTherm treatment center in Germany, which should help us reach our treatment goals for 2021 – tripling the number of commercial treatments compared to 2020.

MagForce continues to work tirelessly to establish the NanoTherm Therapy System for the benefit of brain tumors patients throughout Europe.

MagForce USA, Inc. – USA – Prostate Cancer Treatment:

In the USA it was estimated in 2019 that there were 174,000 new cases of prostate cancer and inspite of advances in diagnosis and treatment an estimated 31,000 deaths occured according to the American Society of Clinical Oncology. MagForce’s focal ablation approach targets patients who have progressed to intermediate prostate cancer stages and are under active surveillance. By destroying smaller cancer lesions, it is anticipated that patients will be able to remain in Active Surveillance programs and avoid, for as long as possible, definitive therapies such as surgery or whole gland radiation with their well-know side effects.

Late April, we were pleased to announce that MagForce USA, Inc. received FDA approval for a streamlined trial protocol for the next stage of our pivotal US study with the NanoTherm therapy system for the focal ablation of intermediate risk prostate cancer. During Stage 1, MagForce USA successfully developed and validated a new standardized clinical procedure. With a streamlined protocol we are able to treat patients much faster than in Stage 1, where each step, instillation and activation, took much longer. Now, both steps will be completed on the very same day, which should favorably affect the duration of the trial. Clearly, the streamlined trial protocol benefits the patients by completing the whole treatment within one day, thus minimizing the burden of repeated visits at the physicians office.

Initial findings during Stage 1 showed only minimal treatment-related side effects, which were tolerable and similar to those commonly associated with biopsies. The ablation analysis showed very well-defined ablation and cell death in the region of the nanoparticle deposit, as was observed in the previous pre-clinical studies.

The current stage of our study is conducted in phases to ensure early on that the minimal side effects observed in Stage 1, with a drawn out procedure, are maintained in the streamlined one-day procedure. Treatment of the first ten subjects should be sufficient to affirm expected minimal side effects. By the fourth quarter of 2020, we believe we will have sufficient data to reinforce the initial finding that our streamlined procedure continues to show minimal patient side effects and achieve the required 80 percent confidence that the clinical objectives can be met.

After ethics committee clearance in June 2020, first patients were enrolled into the next stage and patient treatments have started. MagForce initially began treating patient in one treatment center, making continuous treatments more efficient given clinic and travel resitrictions due to COVID-19. Nothwithstanding further pandemic restrictions, the additional two treatment centers will initiate treatments by the beginning of December.

While finishing the trial, we will start with our activities to prepare for commercialization, which we expect will commence during the second half of 2021. All three participating clinical trial sites are already fully equipped with the NanoActivator devices and would be in a position to start commercial treatments immediately following approval by the FDA. Once the study is completed, we anticipate that two additional MagForce owned treatment centers will have been added. Further sites will then be opened in strategic locations across the USA to allow patients to be treated locally. MagForce is already in contact with the most significant Active Surveillance Programs across the country to allow for a consistent stream of potential patients once the therapy is launched.

We must acknowledge that COVID-19 has created worldwide disruptions. With this in mind, we will surely experience some delays, even though the structure we have implemented in the USA permits MagForce to continue its clinical registration trial.

Increased commercial revenues, flexibility in fincancing tools and a committed management team

MagForce is sufficiently funded and we have several options available to secure further financing in the current market environment if needed. To ensure we remain in contact with investors, we have participated in several virtual roadshows and conferences since the start of the pandemic.

Encouragingly, we see that our commercial strategy in Europe is progressing well; we receive a constant flow of income resulting directly from increased commercial treatments, as described above – these revenues cover our expenses to an increasing extent.

The Company has extended the executive board contracts of Christian von Volkmann as Chief Financial Officer and myself, Ben Lipps, as Chief Executive Officer of MagForce AG for another two years to ensure timely execution of the Company’s strategy as outlined above. Prof. Hoda Tawfik will not extend her contract and depart the Company upon the end of her appointment to the Management Board. I would like to use this opportunity to thank Hoda for her long-time contribution to MagForce, especially with regards to the post-marketing study in Europe and introducing our technology to key opinion leaders and neurosurgeons across Europe. We wish Hoda all the best in her future endeavours. At the same, time I am proud that we have built a successful commercial team under the leadership of Dr. Andreas Jordan, Executive Vice President, Managing Director Europe and Chief Scientific Officer, which has made important milestones in our European roll-out strategy that have reflected in increasing glioblastoma treatment numbers.

In summary, MagForce has passed several major milestones and made significant progress with the NanoTherm therapy system both in the EU, with our brain cancer treatment expansion strategy, and the USA where we aim to bring our innovative approach to develop a minimum risk focal ablation therapy for Active Surveillance to prostate cancer patients. For the future MagForce envisions that NanoThern technology can be applied to any solid tumor with no metastization that is confirmed by targeted biopsy.

I would like to express my thanks to our employees for their tireless efforts and achievements and you, our shareholders, for placing your trust in our mission.

Sincerely,

Dr. Ben Lipps
Chief Executive Officer &
Chairman of the Management Board MagForce AG
Chief Executive Officer MagForce USA, Inc.”

About MagForce AG and MagForce USA, Inc.
MagForce AG, listed in the Scale segment of the Frankfurt Stock Exchange (MF6, ISIN: DE000A0HGQF5), together with its subsidiary MagForce USA, Inc. is a leading medical device company in the field of nanomedicine focused on oncology. The Group’s proprietary NanoTherm^(R) therapy system enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles.

NanoTherm^(R), NanoPlan^(R), and NanoActivator^(R) are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of glioblastoma. MagForce, NanoTherm, NanoPlan, and NanoActivator are trademarks of MagForce AG in selected countries.

Contact:
Barbara von Frankenberg
VP Communications & Investor Relations
T +49-30-308380-77
M bfrankenberg@magforce.com

For more information, please visit: www.magforce.com
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Disclaimer
This release may contain forward-looking statements and information which may be identified by formulations using terms such as “expects”, “aims”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates” or “will”. Such forward-looking statements are based on our current expectations and certain assumptions, which may be subject to a variety of risks and uncertainties. The results actually achieved by MagForce AG may substantially differ from these forward-looking statements. MagForce AG assumes no obligation to update these forward-looking statements or to correct them in case of developments, which differ from those, anticipated.

Relief and NeuroRx Announce Partnership for Global Commercialization of RLF-100(TM) and Selection of Commercial Partners

• RLF-100(TM) (Aviptadil) is in advanced stages of phase 2b/3 development in the US
• Rapid recovery of patients on ventilators and ECMO (extracorporeal membrane oxygenation) has been reported under FDA Emergency Use IND authorization at multiple clinical sites

Geneva, Switzerland, and Radnor, PA, September 21, 2020 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief” or the “Company“) and NeuroRx, Inc. today announced the completion of their partnership agreement for the commercialization of RLF-100(TM)(Aviptadil) worldwide. The two organizations have agreed to share all profits from sales of RLF-100 for all indications related to COVID-19 and potentially other respiratory indications on a global basis. They have agreed that NeuroRx will lead commercialization in the United States, Canada, and Israel, while Relief will lead commercialization in Europe and the rest of the world. Profits from sales will be allocated to Relief and NeuroRx on a 50/50 basis in the U.S., Canada and Israel, 85/15 (in favor of Relief) in Europe, and 80/20 (in favor of Relief) in all other territories.

The two companies have now taken steps to increase manufacturing of the aviptadil drug substance and are in the final stages of contracting with a fill/finish manufacturer, along with a national distribution partner. By January 2021, Relief and NeuroRx expect to have manufacturing, distribution and logistics capacity in place to deliver sufficient drug quantities to treat 150,000 patients per month with RLF-100. The companies continue to anticipate reporting top-line data from the ongoing randomized, double-blinded, placebo-controlled trial of intravenously-administered RLF-100 before the end of 2020. The trial of inhalation-administered RLF-100 is slated to begin enrollment within the coming weeks.

As part of their agreement, Relief and NeuroRx intend to pursue the issuance of trademarks on RLF-100. NeuroRx shall prosecute such trademarks in the U.S., Canada and Israel, while Relief shall prosecute trademarks in all other territories.

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, said: “We are pleased to reach this agreement with NeuroRx, a partner we believe is best suited to ensure rapid clinical development as well as timely and expedient interaction with regulatory authorities in what is likely to be the most important market for the drug, the United States. We are looking forward to collaboratively and productively working together in order to maximize the value of the overall franchise for our shareholders and get this potentially life-saving drug to patients as swiftly as possible.”

Jonathan C. Javitt, Chief Executive Officer of NeuroRx, added: “As the global pandemic continues to devastate families and communities, our small team is encouraged by the early promise we have seen in Sami Said’s scientific legacy and we are working around the clock to bring this drug to patients.”

About VIP in Lung Injury
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type 2 cell, that is critical to transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.

COVID-19-related death is primarily caused by Respiratory Failure. Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells. These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the route of entry for the SARS-CoV-2 into the cells. Coronaviruses are shown to replicate in alveolar type 2 cells, but not in the more numerous type 1 cells. These same type 2 alveolar cells have high concentrations of VIP receptors on their cell surfaces giving rise to the hypothesis that VIP could specifically protect these cells from injury.

Injury to the type 2 alveolar cells is an increasingly plausible mechanism of COVID-19 disease progression. (Mason 2020). These specialized cells replenish the more common type 1 cells that line the lungs. More importantly, type 2 cells manufacture surfactant that coats the lung and are essential for oxygen exchange. Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.

About RLF-100
RLF-100 (Aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Dr. Said’s original work at Stony Brook University, for which Stony Brook was awarded an FDA Orphan Drug Designation in 2001. VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant. FDA has now granted IND authorization for intravenous and inhaled delivery of RLF-100 for the treatment of COVID-19 and awarded Fast Track designation. RLF-100 is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Since July 2020, severe COVID-19 patients have been treated with RLF-100 under U.S. FDA Emergency Use Investigational New Drug (IND) authorization and Expanded Access Protocol authorization for the treatment of respiratory failure in COVID-19.

About RELIEF THERAPEUTICS Holding SA
Relief focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Relief holds orphan drug designations from the U.S. FDA and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a patent issued in the U.S. and multiple other countries covering potential formulations of RLF-100.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF.

About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug development experience and is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca, PPD. In addition to its work on RLF-100, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. Javitt, MD, MPH, who has served as a health advisor to four Presidential administrations and worked on paradigm-changing drug development projects for Merck, Allergan, Pharmacia, Pfizer, Novartis, and Mannkind, together with Robert Besthof, MIM, who served as the Global Vice President (Commercial) for Pfizer’s Neuroscience and Pain Division. Its Board of Directors and Advisors includes Hon. Sherry Glied, former Assistant Secretary, U.S. Dept. of Health and Human Services; Mr. Chaim Hurvitz, former President of the Teva International Group, Lt. Gen. HR McMaster, the 23rd National Security Advisor, Wayne Pines, former Associate Commissioner of the U.S. Food and Drug Administration, Judge Abraham Sofaer, and Daniel Troy, former Chief Counsel, U.S. Food and Drug Administration.

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG and/or NeuroRx, Inc. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

CORPORATE CONTACTS
RELIEF THERAPEUTICS Holding SA:
Raghuram (Ram) Selvaraju, Ph.D., MBA
Chairman of the Board
contact@relieftherapeutics.com

NeuroRx, Inc.:
Jonathan C. Javitt, M.D., MPH
Chief Executive Officer
NeuroRx, Inc.
ceo@neurorxpharma.com

MEDIA CONTACT
Relief (Europe):
Anne Hennecke / Brittney Sojeva
MC Services AG
relief@mc-services.eu
+49 (0) 211-529-252-14

NeuroRx (United States):
David Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310

INVESTOR RELATIONS
Relief (Europe):
Anne Hennecke / Brittney Sojeva
MC Services AG
relief@mc-services.eu
+49 (0) 211-529-252-14

NeuroRx (United States):
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122

Berlin, 18 September 2020. Eckert & Ziegler Strahlen- und Medizintechnik AG (EZAG) plans to run its business with tumor radiation equipment together with TCL Healthcare Equipment (Shanghai) Co., Ltd. (TCL). The two companies today signed a binding letter of intent under which EZAG will transfer its division with the so-called afterloaders (HDR brachytherapy) to a separate company in which TCL will acquire 51% of the shares. Sales revenues with HDR brachytherapy products amounted to approximately EUR 11 million in fiscal year 2019. The transaction is expected to be completed by the end of 2020.

Your contact:
Eckert & Ziegler AG, Karolin Riehle, Investor Relations Robert-Rössle-Str. 10, 13125 Berlin
Tel.: +49 (0) 30 / 94 10 84-138, karolin.riehle@ezag.de, www.ezag.com