Everest Medicines Announces Half-Year 2021 Interim Results

SHANGHAI, Aug. 30, 2021 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced its half-year 2021 interim results, along with corporate progress update.

"I'm very pleased with the ongoing clinical and commercial readiness progress that our teams have made in the past several months, achieving a number of significant milestones that continue to position the Company for long-term growth. In addition to advancing our robust and promising pipeline of clinical-stage therapeutic candidates, including the successful submission of an NDA for eravacycline and a BLA for sacituzumab govitecan, we are preparing for a number of late-stage clinical trial data readouts by the end of the year and also executing on a strategic and comprehensive plan to enable the successful launch of products as we move quickly towards becoming a commercial organization," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "As we continue to leverage and grow our unique in-licensing capabilities and expertise, we are also excited to expand the business with our newly-established and fast-growing discovery organization, which underscores and supports our efforts to become a leading integrated biopharmaceutical company. We have a number of exciting and important milestones and announcements upcoming. We will keep delivering across our key corporate and clinical initiatives, including completing several licensing and strategic transactions."

Recent Product Highlights and Anticipated Milestones

Sacituzumab govitecan-hziy (Trodelvy^TM), our anchor drug candidate in oncology therapeutic area, is a first-in-class TROP-2 directed antibody-drug conjugate (ADC).

• Development achievements during the Reporting Period:
• On 17 May 2021, the China National Medical Products Administration (NMPA) accepted for review the Company's biologics license application (BLA) for sacituzumab govitecan-hziy, an investigational therapy for the treatment of second-line metastatic triple-negative breast cancer (TNBC). Subsequently, sacituzumab govitecan-hziy was granted priority review by the Center for Drug Evaluation (CDE) of China NMPA.
• The Ministry of Food and Drug Safety in South Korea granted orphan drug designation and fast track designation to sacituzumab govitecan-hziy in metastatic TNBC in May 2021.
• Our partner Gilead Sciences, Inc. (Gilead) received full approval from the US Food and Drug Administration (FDA) for sacituzumab govitecan-hziy (Trodelvy^TM) for the treatment of adult patients with second-line metastatic TNBC in April 2021. The approval is supported by data from the phase 3 ASCENT study. In this study, Trodelvy^TM demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending the median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). Trodelvy^TM also extended the median overall survival (OS) to 11.8 months vs. 6.9 months (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), representing a 49% reduction in the risk of death. The most frequent Grade ≥3 adverse reactions for sacituzumab govitecan-hziy compared to single-agent chemotherapy in the study were neutropenia (52% vs. 34%), diarrhea (11% vs. 1%), leukopenia (11% vs. 6%) and anemia (9% vs. 6%). Adverse reactions leading to treatment discontinuation occurred in 5% of patients receiving sacituzumab govitecan-hziy. The Trodelvy^TM U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea.
• In April 2021, our partner Gilead received accelerated approval from the US FDA for sacituzumab govitecan-hziy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either a programmed cell death protein-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. The accelerated approval was based on data from the phase 2, single-arm TROPHY study of 112 patients, which found that Trodelvy^TM achieved a 27.7% overall response rate with a 7.2-month median duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.
• On 6 January 2021, the CDE of the China NMPA approved a clinical trial application (CTA) for sacituzumab govitecan-hziy for the treatment of patients with mUC. With this CTA, we plan to enroll patients in China as part of the phase 3, global, multicenter, open-label randomized controlled TROPiCS-04 trial. The trial will evaluate sacituzumab govitecan-hziy compared with standard of care chemotherapeutic options in subjects with metastatic or locally advanced unresectable urothelial cancer who have progressed after prior therapy with a platinum-based regimen and PD-1/PD-L1 therapy.
• A phase 3 Asia study was initiated, which is designed to assess and compare the efficacy and safety of sacituzumab govitecan-hziy versus treatment of physician's choice in Asian patients with hormone receptor positive, HER2 negative metastatic breast cancer (HR+/HER2- mBC) who have failed at least two prior chemotherapy regimens. The trial will enroll approximately 330 HR+/HER2- mBC patients in Greater China and South Korea. The study is currently ongoing.
• On 31 March 2021, the CDE of the China NMPA approved a CTA for a phase 2 basket trial for a variety of cancers with high TROP-2 expression. The trial is designed to evaluate sacituzumab govitecan-hziy in 180 patients with relapse/refractory esophageal squamous cell carcinoma, gastric cancer, and cervical cancer at select sites in China.
• On 6 January 2021, we submitted a new drug application (NDA) to the Health Sciences Authority (HSA) of Singapore for sacituzumab govitecan-hziy for the treatment of patients with metastatic TNBC, and the indication was subsequently amended to second-line metastatic TNBC.
• Post-Reporting Period (expected) milestones and achievements:
• On 26 August 2021, the first person has been dosed in China as part of the global phase 3 registration trial, TROPiCS-04, in mUC.
• On 29 July 2021, the Taiwan FDA granted pediatric and rare severe disease priority review designation for sacituzumab govitecan-hziy, an investigational treatment for adult patients with second-line metastatic TNBC.
• In the second half of 2021, we expect to read out topline results of a phase 2b China registrational clinical trial for metastatic TNBC, EVER-132-001, and submit a BLA for sacituzumab govitecan-hziy for metastatic TNBC in Taiwan and South Korea. The initiation of our phase 2 Asia basket trial for a variety of cancers with high TROP-2 expression is expected in the second half of 2021 as well.
• The Company expects to receive a BLA approval for sacituzumab govitecan-hziy for the treatment of second-line metastatic TNBC in the first half of 2022.
• Our partner Gilead anticipates PFS data readout from its global phase 3 TROPiCS-02 study for HR+/HER2- mBC and providing an update on the phase 2 TROPiCS-03 basket study, particularly in non-small cell lung cancer (NSCLC) in the second half of 2021.

Nefecon, our anchor drug candidate in cardio-renal therapeutic area, is a novel oral formulation of budesonide in the development for the treatment of IgA nephropathy (IgAN).

• Development achievements during the Reporting Period:
• Chinese patient enrollment into the NefIgArd phase 3 global registrational study evaluating Nefecon as a treatment for IgAN was completed.
• Our partner Calliditas Therapeutics AB (Calliditas) submitted an NDA to the US FDA for Nefecon for the treatment of primary IgAN on 15 March 2021 and was granted priority review on 28 April 2021 with a target Prescription Drug User Fee Act (PDUFA) date of 15 September 2021. The NDA submission is based on positive data from part A of the NefIgArd pivotal phase 3 study, which achieved its primary endpoint of proteinuria reduction compared to placebo. The primary endpoint analysis showed a 31% mean reduction in the 16 mg arm versus baseline, with placebo showing a 5% mean reduction versus baseline, resulting in a 27% mean reduction at 9 months (p=0.0005) of the 16 mg arm versus placebo. The trial also met the key secondary endpoint, showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment with Nefecon compared to placebo. Nefecon was also generally well-tolerated, and the safety profile was in keeping with the phase 2b results and consistent with the known safety profile of budesonide.
• Our partner Calliditas was granted Accelerated Assessment procedure for Nefecon for the treatment of IgAN from the European Medicines Agency (EMA) on 23 April 2021, followed by a marketing authorization application submission to the EMA on 28 May 2021. If approved, Nefecon could be available to patients in Europe in the first half of 2022.
• Post-Reporting Period (expected) milestones and achievements:
• We expect to read out proteinuria data from the global phase 3 NefIgArd study in Chinese patients who were treated with Nefecon, and submit an NDA to the China NMPA in the first half of 2022.

Eravacycline (Xerava^TM), is a novel, fully synthetic fluorocycline intravenous antibiotic developed for use as first-line empiric monotherapy for the treatment of multidrug resistance (MDR) infections, including MDR Gram-negative infections.

• Development achievements during the Reporting Period:
• The China NMPA accepted an NDA for eravacycline for the treatment in complicated intra-abdominal infections (cIAI) in China in March 2021.
• Post-Reporting Period (expected) milestones and achievements:
• The CDE of the NMPA approved a CTA for eravacycline for the treatment of community-acquired bacterial pneumonia (CABP) in August 2021.
• We expect NDA approval for eravacycline for the treatment in cIAI in China in the first half of 2022.

Other clinical-stage assets

• Development achievements during the Reporting Period:
• Ralinepag is a next-generation, potent, selective oral IP prostacyclin receptor agonist being developed for the treatment for pulmonary arterial hypertension (PAH). We continue to progress our phase 3 registrational trial for PAH in China as part of a global phase 3 study conducted together with our partner United Therapeutics.
• Post-Reporting Period (expected) milestones and achievements:
• We plan to initiate a phase 2 clinical trial for FGF401 for the treatment of FGF19 amplified hepatocellular carcinoma patients in China in the second half of 2021.
• We are conducting a phase 3 study for etrasimod for the treatment of moderate-severe ulcerative colitis (UC), which is expected to complete enrollment in the first half of 2022.
• Our partner Arena Pharmaceuticals, Inc. expects to read out topline data from both ELEVATE UC 12 and ELEVATE UC 52 with etrasimod in the first quarter of 2022 as well as data from the phase 2/3 CULTIVATE sub-study, a dose-ranging study of etrasimod for Cohn's disease, in the second quarter of 2022.
• We expect to announce topline results of the phase 3 global clinical trial for taniborbactam for complicated urinary tract infections (cUTI) in the first quarter of 2022.
• We expect to initiate a phase 1 study of SPR206 in the second half of 2021.

Business Development

Our business development team is actively working on a number of licensing, research collaboration and partnership transactions across our therapeutic areas of focus, and we expect to aggressively pursue value accretive and strategic deals to broaden our pipeline and complement our internal discovery initiatives.

Commercialization

We are building an industry-leading commercial team with three business units focused on oncology, internal medicine and infectious disease under the leadership of Kevin Guo, we have also expanded our geographical footprint with newly established offices and general managers in South Korea, Taiwan and Singapore to ensure commercial success in those markets. We recently established strategic collaborations with key industry partners, including Tencent Holdings Limited, Medbanks Health Technology Co., Ltd and MediTrust Health Co., Ltd., to explore innovative ways to improve drug access and to reduce economic burden to patients through digital marketing, patients access and reimbursement solutions.

Discovery

We are committed to building a strong discovery organization by recruiting experienced talents in drug discovery and translational medicines, and exploring new modalities and technology platforms to accelerate our discovery efforts. Our new research laboratory in Zhangjiang, Shanghai is expected to be fully operational in the first quarter of 2022.

Manufacturing Facility

We are making steady progress on the construction of our global manufacturing site in Jiashan, Zhejiang Province to meet demands in both China and the global market. Phase 1a of the facility construction including quality control and office building is expected to be completed in 2022 and phase 1b containing production, repackaging, and warehouse is expected to be completed in 2023.

Other Key Corporate Development

• On 18 February 2021, we appointed Kevin Guo as our chief commercial officer. Mr. Guo has more than 22 years of commercial leadership and business management experience across a number of multinational pharmaceutical companies. Under Mr. Guo's leadership, we continue to remain focused on advancing our work across four strategic pillars to launch strategy formulation, develop commercial capabilities, embrace and deploy innovative solutions, and expand our international footprint.
• In July 2021, the Company established key strategic partnerships with Tencent Holdings Limited, Medbanks Health Technology Co., Ltd and MediTrust Health Co., Ltd. to explore innovative tools in digital marketing, patients' access to novel medicines and payment solution. These are just first steps to achieving our strategic commercial goals of delivering a differentiated omni-channel approach to better engage with healthcare providers, payors and patients.
• On 15 April 2021, we appointed Dr. Jennifer Yang as our chief scientific officer, whose deep expertise in drug discovery and translational medicine will help the Company establish a robust discovery organization that contributes to the strategic expansion of our clinical development pipeline.
• Effective 18 June 2021, the Company's stock was included as a constituent stock of the Small Cap Index, FTSE All-Cap Index and FTSE Total-Cap Index in the FTSE Global Equity Index Series.
• Effective 15 March 2021, the Company was selected as a constituent stock of the Hang Seng Composite Index, the Hang Seng Healthcare Index and the Hang Seng Hong Kong-Listed Biotech Index in accordance with the latest index series released by Hang Seng Indexed Company Limited. At the same time, the Company became eligible for Southbound Trading under the Stock Connect Scheme, which is a channel that facilitates stock trading and investment between Hong Kong and a broader base of Chinese investors.

Financial Highlights

IFRS Numbers:

• Research and development (R&D) expenses increased by RMB89.8 million from RMB161.0 million for the six months ended 30 June 2020 to RMB250.8 million for the six months ended 30 June 2021, primarily due to: (i) additional clinical trials of our drug candidates; (ii) expansion of our R&D team; and (iii) the establishment of an internal discovery team to build in-house R&D capability.
• General and administrative expenses increased by RMB6.1 million from RMB101.3 million for the six months ended 30 June 2020 to RMB107.4 million for the six months ended 30 June 2021, mainly due to increase in employee remuneration in connection with organization expansion.
• Distribution and selling expenses increased by RMB32.9 million from RMB9.2 million for the six months ended 30 June 2020 to RMB42.1 million for the six months ended 30 June 2021, primarily due to the build up of a commercial team and pre-launch activities carried out for upcoming products commercialization.
• Net loss for the period decreased by RMB240.4 million from RMB623.5 million for the six months ended 30 June 2020 to RMB 383.1 million for the six months ended 30 June 2021, primarily attributable to the decrease in loss from fair value change of financial instruments issued to investors.
• Other comprehensive income increased by RMB284.7 million from RMB282.6 million for the six months ended 30 June 2020 to RMB567.3 million for the six months ended 30 June 2021, primarily attributable to the increase in income from fair value change of financial assets at fair value through other comprehensive income.
• Cash and cash equivalents amounted to RMB3,971.0 million as of 30 June 2021.

Non-IFRS Measure:

• Adjusted loss for the period^[1] increased by RMB57.2 million from RMB245.9 million for the six months ended 30 June 2020 to RMB303.1 million for the six months ended 30 June 2021, primarily attributable to increase in R&D expense and distribution and selling expenses.

Conference Call Information

A live conference call will be hosted on August 31, 2021 at 9:00 AM Beijing Time (August 30, 2021 at 9:00 PM U.S. Eastern Time). Participants must register in advance of the conference call.  Details are as follows:

Registration Link: https://apac.directeventreg.com/registration/event/5468938

Conference ID: 5468938

All participants must use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive dial-in number, passcode and a unique registration ID, which can be used to join the conference call.

A replay will be available shortly after the call and can be accessed by visiting the Company's website at http://www.everestmedicines.com.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.