AiCuris Provides Corporate Update - November 12, 2019

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  • Over 15,000 patients worldwide already treated with Letermovir to prevent Cytomegalovirus (CMV) infection and disease in allogeneic stem cell transplantation
  • Pritelivir in Phase 2 testing for treatment of Acyclovir resistant HSV infections in immune-comprised patients; AiCuris is preparing a pivotal Phase 3 trial
  • AIC649, a potential cure for chronic hepatitis B, to be partnered
  • Company fully dedicated to develop novel antibiotics to combat antimicrobial resistance
  • Significant ongoing revenue stream provides funding to carry out ambitious plans

Wuppertal, Germany, November 12, 2019 - AiCuris Anti-infective Cures GmbH today provided a strategic update, outlining its recent achievements and plans for future growth. AiCuris specializes in the discovery, research and development of novel resistance-breaking antiviral and antibacterial agents for the treatment of serious, often life-threatening infectious diseases, and is one of the few biotech companies to see its drug brought to market and thereby to patients. This work has earned the Company and its founders several high-profile awards, including the coveted German Future Prize.

“We are very pleased of our achievements and are fortunate to be in the position of having a significant, ongoing revenue stream from the first program we developed and licensed. The income generated from our licensing agreement with MSD for Letermovir, which is on the market, is enabling us to build and advance our proprietary pipeline, which is focused on developing truly novel treatments against infectious diseases,” said Dr. Holger Zimmermann, CEO of AiCuris. “Part of our work is dedicated to finding new ways to address antimicrobial resistance, despite so many other companies abandoning this field. We are excited about this important work we are also doing in partnership with others and look forward to advancing programs that have the potential to cure patients and address major unmet medical needs.”

Commercial product, Prevymis® (Letermovir) – a life-saving "game changer" in transplantation medicine – providing ongoing revenue stream

Letermovir, an oral, once-daily anti-viral treatment, was first approved in late 2017 under the MSD brand name Prevymis® and is the first and still only drug indicated for the prophylactic treatment of human cytomegalovirus (HCMV) infections in bone marrow transplanted patients. HCMV infection is one of the most dangerous complications following bone marrow transplantation. The therapy was successfully developed by AiCuris to Phase 2b and then out-licensed to Merck & Co. (MSD) for further development and commercialization. Since market launch, approximately 15,000 patients have been treated with Letermovir globally: Based on a 5% increase in survival rates shown in the pivotal phase 3 study with Letermovir, this means that estimated 750 lives have been saved. Letermovir might also be useful in other HCMV indications and is currently being developed for additional indications in solid organ transplantation, a pivotal study for the prophylactic treatment of HCMV in kidney transplant recipients is ongoing.

Growth through innovative approaches and strategic alliances

AiCuris' mission is to develop innovative drugs against severe and life-threatening infectious diseases with high medical need. Development is focused on indications for which there are either no therapeutic options or for which available therapies are not effectively addressing the disease. With its scientific expertise and extensive experience in preclinical and clinical development, the Company is developing candidates that either belong to a new drug class and/or have a completely novel mechanisms of action. AiCuris develops its projects up to proof-of-concept and then follows a selective out-licensing strategy. To further expand its portfolio, AiCuris has entered into a number of collaboration agreements and strategic alliances and will continue to do so. For example, this summer, the Company announced a long-term collaboration with Lysando, focused on the joint development and optimization of human drug candidates utilizing Lysando’s Artilysin®s technology platform against bacteria. In 2018, AiCuris signed a collaboration agreement with Cyclenium Pharma Inc. focused on finding therapies for the treatment and prevention of bacterial and viral diseases utilizing Cyclenium’s novel QUEST Library™ of next generation synthetic small-molecule macrocycles.

Internal development program Pritelivir – Phase 2 trial ongoing, AiCuris to conduct Phase 3 pivotal trial in Acyclovir resistant HSV infections in immunocompromised patients

Pritelivir (AIC316) is a highly potent inhibitor of herpes simplex virus (HSV) replication and is active against both HSV types 1 and 2. Pritelivir belongs to a new chemical class and acts via a novel mechanism of action. In contrast to currently used nucleoside analogues, Pritelivir does not require activation by viral enzymes and can thus protect uninfected cells. Pritelivir also retains activity against viruses which have become resistant to current standard of care drugs. Pritelivir has demonstrated superior efficacy in a Phase 2 trial compared to the standard treatment, valaciclovir, and is currently in another Phase 2 trial in immunocompromised patients with acyclovir-resistant infection. AiCuris plans to initiate a pivotal Phase 3 trial with Pritelivir in HSV infections in 2020.

Partner sought for AIC649, a potential cure for chronic hepatitis B

AIC649 is a novel biological immunomodulator being developed for the curative treatment of chronic hepatitis B virus infections. Results from a successfully completed Phase 1 study showed that a single intravenous dose of AIC649 was safe and well tolerated; there were no dose-limiting toxicities and the maximum tolerated dose was not reached. Despite the heterogeneity of the patients in the trial, there was evidence that a single dose of AIC649 stimulated the immune system. Earlier preclinical results in a chronic hepatitis B model indicated that treatment with AIC649 in combination with standard treatment entecavir could lead to functional cure. Given the large size of the market, AiCuris is looking for a partner for the further development and commercialization of AIC649 to maximize the opportunity for this exciting product candidate.

Antibacterial agents - AiCuris is fighting multidrug-resistant bacteria in cooperation with Lysando

Antibiotic resistance is one of the greatest threats to human health worldwide, creating an urgent need for innovative solutions to address this growing problem. AiCuris is one of the few European companies that is still active in this field and is focused on developing new antibacterial agents that overcome resistance. The Company has extensive expertise in developing novel, effective therapies against infectious diseases and believes it is in a strong position to attack antibiotic resistance in new ways. To strengthen its chances of success, AiCuris has joined forces with Lysando, whose Artilysin technology platform can deliver a completely new class of molecules with a novel mode of action, offering the potential to replace conventional antibiotics.

About AiCuris Anti-infective Cures GmbH

AiCuris was founded in 2006 as a spin-off from Bayer and focuses on the discovery and development of drugs targeting infectious diseases. SANTO Holding is the Company’s majority investor. PREVYMIS® (Letermovir), a first-in-class non-nucleoside cytomegalovirus (CMV) inhibitor acting via a novel mechanism of action, was licensed to MSD in 2012 and is approved in the EU, the USA, Japan and other parts of the world for use in bone marrow transplants for the prevention of HCMV infections in adults who receive an allogeneic hematopoietic stem cell transplant. The Company is developing drugs for the treatment of viruses such as human CMV, herpes simplex virus (HSV), hepatitis B virus (HBV), and adenoviruses. In the field of antibacterials, AiCuris seeks to develop innovative treatment options for life-threatening, multidrug-resistant, hospital-treated pathogens.

In 2018 Prof. Dr. Helga Rübsamen-Schaeff, Founding CEO, and Dr. Holger Zimmermann, CEO of AiCuris, were awarded the German Future Prize 2018 (German President's Award for Innovation in Science and Technology) for the development of Letermovir and their project, "Protection in the Absence of the Immune System - a Life-Saving Innovation against Dangerous Viruses" (original title: “Schutz bei fehlendem Immunsystem - die lebensrettende Innovation gegen gefährliche Viren").

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