SHANGHAI, CHINA, Mar 19, 2021 – (ACN Newswire) – Hua Medicine (the "Company", Stock Code: 2552.HK), today announces the audited annual results of the Company and its subsidiaries for the year ended December 31, 2020 (the "Reporting Period"). During the Reporting Period, the Company continued to advance various clinical trials and R&D investments, successfully completed two Phase III registration trials for dorzagliatin in China, and achieved remarkable results in preparing for dorzagliatin's commercialization. These 2020 achievements provide a solid foundation for the Company's long-term and stable development in the future. In 2020, the Company incurred approximately RMB367 million in total expenditures, of which approximately RMB221 million was research and development expenses. As of December 31, 2020, the Company's cash position was approximately RMB1,032 million, a decline of only RMB74 million from the 2019 year-end cash balance of RMB1,106 million, due principally to the inflow of non-dilutive upfront payment by Bayer AG of RMB 300 million.

Over the past decade, Hua Medicine has focused on unmet medical needs and relentlessly pursued breakthroughs in a major disease area, successfully realizing the world's leading scientific concept into the first-in-class oral glucokinase activator, dorzagliatin, with a breakthrough innovation mechanism. With the successful completion of two registration trials, dorzagliatin's scientific thesis of "Repairing sensors, reshaping homeostasis and fundamentally treating diabetes" has been validated. Hua Medicine has become the first company in the world to complete clinical development of a glucokinase activator. The results of the two Phase III clinical trials demonstrated that dorzagliatin has long-term sustained efficacy, and good safety and tolerability profiles. By repairing the damaged expression of glucokinase in patients with diabetes, dorzagliatin has the potential to improve beta-cell function, reduce insulin resistance and ultimately restore the self-regulation of blood glucose. Dorzagliatin has progressed from 0 to 1 – from a disruptive scientific theory to a potential commercially viable product, propelling Hua Medicine into a new stage of development.

The unique mechanism of dorzagliatin is also expected to create a new era of personalized and precision treatment of diabetes. Results from two Phase I clinical trials, HMM0111 and HMM0112, announced in the first half of 2020 demonstrated that dorzagliatin combined with DPP-4 inhibitors and SGLT-2 inhibitors, respectively, have a clear synergistic effects in blood glucose control, indicating that dorzagliatin has a wide range of application potential in Type 2 diabetes ("T2D") patients with different glucose control needs and at different disease stages. Meanwhile, data from HMM0111 also indicated that dorzagliatin can promote endogenous GLP-1 secretion and improve beta-cell function in patients (specific research results will be presented at this year's ADA Scientific Sessions). In addition, a Phase I study in patients with end stage chronic kidney disease demonstrated that dorzagliatin is a feasible monotherapy for T2D patients who have diabetic kidney disease ("DKD"), who make up about 20% to 40% of T2D patients. This marks the first oral anti-diabetes therapy that could be available for this group of T2D patients, as current oral therapy are either prohibited or require dose adjustment. The Company will initiate additional clinical trials for dorzagliatin in DKD, and combination therapy with additional diabetes drugs, including with GLP-1 RAs and insulin for T2D patients, and with insulin for T1D patients, to expand the addressable market for dorzagliatin. The Company will also continue to expand in three dimensions: expansion of product pipeline, expansion to global, and expansion into new disease areas to take Hua Medicine from 1 to 10. These will support Hua Medicine in becoming a leading biotechnology company with clinical value, social value and investment value.

"In 2020, we experienced the most serious global public health crisis in a century. Despite the pandemic Hua Medicine has still achieved several milestones and breakthroughs in clinical trials and in the prepartion for drug commercialization. We have completed relevant preparation work and will submit the New Drug Application ("NDA") to the National Medical Products Administration ("NMPA") very soon. We hope to work with our partners to further accelerate the NDA and marketing processes of dorzagliatin for the benefit of diabetes patients in China and around the world." said Dr. Li Chen, founder, CEO and CSO of Hua Medicine.

2020 Clinical Highlights:
– Successfully completed SEED, a Phase III registration trial to investigate the efficacy and safety of dorzagliatin monotherapy in drug naive T2D patients. It was the first Phase III trial conducted by Hua Medicine in China. The 52-week topline data demonstrated that dorzagliatin as a monotherapy has long-term sustained efficacy, and good safety and tolerability profiles.
– Successfully completed DAWN, a Phase III registration trial to investigate the combination therapy of dorzagliatin and metformin on T2D patients inadequately glycemic-controlled with metformin. It is the second Phase III trial conducted by Hua Medicine in China. Both the 24-week and 52-week topline results demonstrated that the combination therapy has long-term sustained efficacy, and good safety and tolerability profiles.
– Presented additional data of the 24-week SEED trial at the 80th American Diabetes Association (ADA) Annual Scientific Sessions, demonstrating significant improvements in beta-cell function and 2h-PPG reduction.
– Announced additional data of the 24-week DAWN trial at the Chinese Diabetes Society's 2020 Scientific Meeting, demonstrating improvements in beta-cell function and reduction in insulin resistance.
– Completed HMM0110, which demonstrated desirable pharmacokinetics profile in patients with end stage chronic kidney disease, indicating the potential use of dorzagliatin with no dose adjustment among T2D patients with diabetic kidney disease.
– Completed HMM0111, investigating the pharmacokinetic and pharmacodynamic parameters of dorzagliatin in combination with sitagliptin (a DPP-4 inhibitor), and demonstrated a clear synergistic effect in efficacy of blood glucose reduction and improvement of beta-cell function, in addition to increased secretion of endogenous GLP-1.
– Completed the clinical trial of HMM0112, investigating the pharmacokinetic and pharmacodynamic characteristics of dorzagliatin in combination with empagliflozin (a SGLT-2 inhibitor) and demonstrated a clear synergistic effect in efficacy of blood glucose reduction and improvement of beta-cell function.

Operational highlights:
– Entered into a commercialization agreement and strategic partnership with Bayer AG for dorzagliatin in China.
– Entered into a commercial supply agreement with Raybow Pharmaceutical, for Raybow to become an additional manufacturing supplier for commercial launch.
– Granted the Drug Manufacturing Permit for dorzagliatin in China by the Shanghai Municipal Drug Administrative Bureau.
– Announced that global operation headquarters and research and development center in Shanghai's Zhang Jiang Science City officially established.

Financial Highlights: For the year ended December 31,2020
– Cash position was approximately RMB1,032 million, representing a decline of only RMB 74 million from the 2019 year-end cash balance, due principally to the inflow of non-dilutive upfront payment by Bayer AG of RMB 300 million.
– Total expenditures incurred by the Company was approximately RMB367.2 million, of which approximately RMB221.0 million was research and development expenses, representing a decrease of approximately 31% (RMB101 million).
– Loss before tax decreased by approximately RMB32.1 million or approximately 8% to approximately RMB393 million.
– Loss and total comprehensive expense for the year decreased by approximately RMB31.7 million or approximately 7% to approximately RMB393.6 million.

Business Outlook
– Plan to submit our NDA for dorzagliatin to the NMPA in China in the first half of 2021.
– Plan to initiate additional studies for dorzagliatin in DKD in the second half of 2021.
– Plan to initiate additional studies for dorzagliatin combinations, including with GLP-1 RAs and insulin for T2D patients, and insulin for T1D patients in the second half of 2021. Advancing the company fixed-dose combination pipeline for dorzagliatin.

About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs. Two Phase III registration trials for dorzagliatin have been completed in China. The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and will submit its NDA to the National Medical Products Administration, so as to realize the "First in Global, Start from China" mission objective for the benefit of diabetic patients worldwide.

About Hua Medicine
Hua Medicine is a leading, innovative biotechnology company in China focused on developing novel therapies for diseases with unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA-enabling stage and it has successfully completed two Phase III registration trials in China for dorzagliatin. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.

For more information
Hua Medicine
Website: www.huamedicine.com

Investors
Email: ir@huamedicine.com

Media
Email: pr@huamedicine.com

Porda Havas International Finance Communications Group

Mr. Bunny Lee +852 3150 6707 bunny.lee@pordahavas.com
Ms. Louisa Chen +86 75523807432 louisa.chen@pordahavas.com
Ms. Karen Chiu +852 3150 6726 karen.chiu@pordahavas.com
Ms. Winnie Tan +852 15915975512 winnie.tan@pordahavas.com


Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

FOSTER CITY, Calif. and HANGZHOU, ZHEJIANG, CHINA, Mar 4, 2021 – (ACN Newswire) – Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, today announced that the first patient has been successfully enrolled into a Phase 1 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) in China. In February of this year, the two Phase 1 study sites were initiated.

The Phase 1 clinical trial is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML. Its principal investigator is Professor Jianxiang Wang of the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. The primary objective of the Phase 1 is to study the pharmacokinetic (PK) characteristics of APL-106 in Chinese subjects with relapsed or refractory AML and to evaluate the safety and tolerability of APL-106 in combination with chemotherapy.

About APL-106 (uproleselan injection)

APL-106 (uproleselan injection) is an innovative drug discovered and developed by GlycoMimetics. Uproleselan (yoo' pro le' sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells, thereby disrupting the mechanism of leukemic cell resistance within the bone marrow microenvironment. In 2017, the U.S. FDA granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia. Apollomics licensed uproleselan from GlycoMimetics in January 2020. Apollomics has the rights to clinical development, production and commercial sales in the Chinese market (Mainland China, Hong Kong, Macau and Taiwan).

In September 2020, APL-106 received the approval of the National Medical Products Administration (NMPA) through the issuance of the "Clinical Trial Drug Approval Notification". This approval enables the conduct of Phase I and Phase III bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory acute myeloid leukemia. In January 2021, APL-106 was also granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the NMPA.

About Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow. It is an aggressive disease that causes the bone marrow to produce immature cells that are unable to carry out their normal function and develop into leukemia cells. In the U.S., there are approximately 20,000 new cases of AML each year, and the 5-year survival rate is 28.7%1. The annual incidence of AML in China in 2019 is approximately 26,9002, and relapsed/refractory AML has an extremely poor prognosis.

About Apollomics, Inc.

Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer. The company's existing pipeline consists of several development-stage assets including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.

1National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program
2Source: CIC Report

Contact information of Apollomics:
Investor Contact:
Wilson W. Cheung
Chief Financial Officer
Telephone: +1-650-209-4436
Email: wcheung@apollomicsinc.com

Company Contact:
Remy Bernarda
Telephone: +1-415-203-6386
Email: remy.bernarda@apollomicsinc.com

China Media Contact:
Porda Havas International Finance Communications Group
Kelly Fung
General Manager
Telephone: (852) 3150 6763
Email: kelly.fung@pordahavas.com

Phoenix Fung
Assistant Vice President
Telephone: (852) 3150 6773
Email: phoenix.fung@pordahavas.com


Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Guangzhou, China, Feb 14, 2021 – (ACN Newswire) – AI-assisted computing has greatly improved the efficiency of new drug research and development. Suntrap Life Technologies Co., Ltd has taken the lead to establish the Suntrap IDDNU(R) platform to serve as an international drug discovery network alliance.

In 2019, Suntrap Life Technologies established a drug research team, carried out comprehensive drug research and development projects, and built the Suntrap IDDNU (Suntrap International Drug Discovery Network Alliance) technology platform. Suntrap IDDNU is based upon the EK-DRD database, published by one of the researchers, Mr. Jason Zhao. (J Chem Inf Model. 2019 Sep 23;59(9):3619-3624. EK-DRD: A Comprehensive Database for Drug Repositioning Inspired by Experimental Knowledge). This database includes detailed information on the US FDA approved 1963 drugs (including those withdrawn from the market), and the activity information in the target, cell, animal, and clinical experiments. In addition, the Suntrap research team also included the structure and activity data of 400,838 natural compounds.

Through the collection of these data and the construction of a database, the Suntrap research team has developed a series of natural compounds for drug redirection. Based on AI drug discovery algorithms and mathematical models, it can quickly calculate the affinity between these compounds and the target, and predict the compound-protein interaction, the ability to discover multi-pharmacological (multi-target) compounds, and the discovery of the correspondence among the drug-target-disease interactions, provide a very efficient platform for systematic pre-screening of drugs. For a variety of diseases, the Suntrap research team has initiated a variety of biological drug research and development pipelines (ie. tumors, viral infections, tissue fibrosis, respiratory infectious diseases, aging-related chronic diseases, and others).

Given that the new coronavirus is still pandemic throughout the world, the Suntrap research team responded and launched the 'Research on Anti-Coronavirus Products' project in early 2020. Drugs claimed to be targeting the coronavirus have been clinically proven to be ineffective and have side-effects. In terms of target selection for the new drug development, the Suntrap research team aims to the development of small molecules with multi-targets, broad-spectrum, and collaborative therapeutic effectiveness, which acts not only to the original coronaviruses but also on the mutants or related strains. The Suntrap IDDNU quickly screened the antiviral activity of natural small molecular compounds from a database of drugs, herbals as well as food components, and discovered the multi-target synergistic anti-coronavirus compound "LeSoleil(R)". The Suntrap research team, together with the Guangdong Provincial Center for Disease Control and Prevention, and the Guangdong Provincial Institute of Public Health, completed the sensitivity study and safety evaluation of 'LeSoleil'. The experimental conclusions show that 'LeSoleil' has significant effectiveness in the in vitro inhibition of the coronavirus (SARS-CoV-2). Further studies confirmed the effectiveness, which laid the foundation for 'LeSoleil' to be further developed into a candidate for the anti-coronavirus drug. The Suntrap's team studies have indicated that 'LeSoleil' has the advantages of low toxicity, good tolerability, and high accessibility, The Suntrap IDDNU guarantees the rapid development of broadspectrum COVID-19 prevention and therapeutic drugs.

'LeSoleil' series of specific drugs for the treatment of new coronavirus pneumonia have completed preclinical trials

In the face of the increasing spread of the new mutant coronavirus strains that are more infectious and elusive, existing drugs and vaccines are not enough to combat and completely eliminate the mutant virus. The world has an urgent need for new coronavirus therapeutic drugs. Based on this understanding, Suntrap's research team took 'LeSoleil' as the main drug component and carried out further development of the 'LeSoleil' series. According to the characteristics of infection, different formulas were tested in drug development.

First of all, an emergency anti-coronavirus protective spray was released, which can effectively block the infection and the spread, while reducing the probability and risk of the mutation of the coronavirus. The protective spray can directly act on the nasal cavity and oral cavity, which are the initial sites where the virus infection manifested in the human body. The studies showed that the 'LeSoleil' spray effectively and stably prevent virus infection, inhibit virus replication, inactivate the virus, and prevent the virus from further infecting the human body. These observations also applied to the asymptomatic infected person who carries the virus, the spray could effectively eliminate the virus from being discharged droplets through breathing, sneezing, coughing, etc. After applying the 'LeSoleil', the exhaled air still retains the active ingredients that can effectively inhibit the virus, making the virus lose its infectivity. At present, the development of the 'LeSoleil' series of nasal and mouth spray formulations has been completed, including formulation design, formulation screening, mechanisms research, process optimization, and the quality evaluations of the QA and QC. The design, the quality control are strictly in accordance with domestic and international FDA regulations, which are complying with the general requirements of the current edition of the 'People's Republic of China Pharmacopoeia'. In addition, these nasal and mouth sprays could also effectively inhibit the inflammatory responses in the lungs, as experimented with the rat animal model of pneumonia. The experimental results show that 'LeSoleil' can prevent the inflammatory storm caused by the coronavirus infection, reduce the damage of the inflammation to the body, and have a good anti-inflammatory effect. At present, Suntrap's research team has also completed the development of 'LeSoleil' series injections, which can treat patients with severe and critical pneumonia caused by coronavirus infection.

Furthermore, pulmonary fibrosis can also be prevented. Pulmonary fibrosis is a common sequela of patients discharged from the hospital with COVID-19, which seriously affects the quality of life and prognosis of patients. Pulmonary fibrosis is also commonly happening in other lung diseases, and currently, there are no effective therapeutics to cure pulmonary fibrosis patients.

Studies have shown that the new coronavirus can directly invade the brain's nervous system, causing loss of sensory such as smell and taste, and affecting the functionality of human neurotransmitters, leading to the onset of anxiety, depression, and other mental illnesses. Suntrap's research team has fully studied the targets related to pulmonary fibrosis and constructed in vivo and in vitro testing models. In the in vitro studies, the TGF-Beta1 induced HFL-1 cells fibrosis can be effectively inhibited, and in the in vivo bleomycin-induced rat pulmonary fibrosis, 'LeSoleil' showed reliable effectiveness in stopping the pulmonary fibrosis processes. The experiment shows that 'LeSoleil' can reduce oxidative stress, inflammation, and fibrosis, which reduce the tendency of post-infection pulmonary fibrosis. In the 'LeSoleil' neuron protection experiment, it was found that it can effectively inhibit the apoptosis of nerve cells, protect neurons and repair the damaged nervous system.

Pulmonary diseases have become more common in recent years. Although the formula and the inhaler are more complex than other forms of administrations, the 'LeSoleil' can directly reach the lungs and be absorbed more effectively. Such routes of absorption also bypass the liver metabolism, which usually happens with oral administration. The advantages are also prominent when compared with muscle injection, as the inhaler delivery reaches the loci more quickly and directly. The Suntrap research team has developed the 'LeSoleil' series administered with inhalation devices, which can treat and prevent pulmonary fibrosis, repair the damaged sensory perception of taste and smell, and are expected to completely improve the prognosis of the new coronavirus pneumonia.

In Conclusion

The weakening trend of the COVID-19 pandemics does not mean that the virus disappears completely or that the next wave of pandemics will not come. The threats of future pandemics are still looming large. The WHO warned that a virus more deadly than the current coronavirus may also be inflicting humans in the future. The Suntrap research team through modeling global pandemics data, in combination with the environmental factors and the effects of social distancing and other quarantine measures, also predicted that some influenza epidemics may also occur from March to May 2021. These epidemics are also expected to be accompanied by an explosive number of cases of pulmonary infection. The symptoms of such pulmonary infections are easily confused with that of coronavirus pneumonia, and there is also a risk of superimposed infection, which makes the coronavirus pandemics even more difficult to be prevented, treated, or managed.

The coronavirus is so small that it is invisible to the naked eye, but it is enough to distress the world. Today, with globalization prevail, no single country or nation can be standing alone unaffected. Under various situations of cultural, commercial, or political situations, the pandemic's impact has become far more complicated than ever. Faced with the COVID-19 pandemics, human beings cannot rely on a sheer stroke of luck. Large-scale testing, mandatory isolation, and restrictions on the movement of people are not the optimal long-term measure. The prevention and control of infectious diseases require a high degree of professionalism. It is essential to adapt and follow the scientific principles in solving such a problem.

Therefore, it is the best strategy that we fight the disease actively, with efficiency as well as rationality so as to keep as much the normal operation of the society, minimize the economic impact, and develop safe and effective medicines for the pandemics.

Experimental researches have proved that the 'LeSoleil' series of drugs can not only block the broad-spectrum coronavirus infection, resist further development of respiratory infection, but also kill the viruses. 'LeSoleil' can also contain and eliminate the inflammatory storm caused by the infection, and prevent pulmonary fibrosis. It is expected that 'LeSoleil' will become an effective drug against this and the coming pandemics. At present, the Suntrap research team has completed the pharmacodynamic, pharmacokinetic, and safety evaluation studies of the 'LeSoleil' series of products. Patents have been filed and authorized in China. Clinical trials are also under planning and are expected to be completed in a short time. The Suntrap team is striving to make 'LeSoleil' available as soon as possible.

Contact:
Suntrap Life Technologies Ltd.
Zoe Zhou
E: 2113@suntrap.com
T: +86 18825197167

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

FOSTER CITY, Calif. and HANGZHOU, ZHEJIANG, CHINA, Feb 12, 2021 – (ACN Newswire) – Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, today announced an exclusive license agreement for the development and commercialization of TYG100 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China, and South Africa.

TYG100 is an antigen-specific, active checkpoint control immunotherapy (ACCI) recombinant vaccine comprising the amino-terminal sequence of G17, a gastrointestinal peptide hormone, and utilizes the S-TIR(TM) technology platform. This technology induces a novel mechanism of action that is able to unmask tumors. TYG100 was developed by TYG oncology Ltd. based in the United Kingdom and received support from Cancer Research UK. TYG oncology originally co-developed TYG100 with Nuance Biotech and this license is now assigned to Apollomics for further co-development.

"TYG100 represents the new era of active checkpoint control immunotherapy by enabling a rapid and appropriate natural immune response," said Guo-Liang Yu, Ph.D., Chief Executive Officer of Apollomics. "In addition, the technology that powers TYG100 enables targeted induction of antibodies neutralizing G17 at the site of the tumor. While this asset is early stage, we are excited about the technology and the opportunity to run preclinical studies and advance it into the clinic for the treatment of gastroenterological cancers."

Under the terms of the agreement, Apollomics will be responsible for clinical development and commercialization in Greater China and South Africa. Nuance Biotech received an upfront cash payment and will be eligible to receive from us potential development milestone payments. TYG oncology will be eligible to receive from us tiered royalties on net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for TYG100 in the territories.

Jian Ni, Chief Executive Officer, Nuance Biotech added, "ACCI is the next generation immunotherapy beyond checkpoint inhibitors, and opens the door to new anti-cancer treatments. Preclinical data support stimulation of significant immune response and studies in non-human primates have been well-tolerated and demonstrated predicted ability to achieve a high level of immune stimulation."

"We appreciate the help that Nuance has provided in getting TYG100 to the next stage of development with Apollomics. We are pleased to have such a strong partner to potentially carry TYG100 into the clinic to patients," concluded Fred Jacobs, Chief Executive Officer, TYG Oncology.

About TYG100

TYG100 is an active checkpoint control immunotherapy (ACCI) recombinant vaccine that targets the gastrin immunogen. In preclinical studies, TYG100 has induced neutralizing antibodies against gastrin, a major growth factor for pancreatic and other forms of gastrointestinal cancer. For additional information, please visit https://www.tyg-oncology.com.

About Apollomics, Inc.

Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer. The company's existing pipeline consists of several development-stage assets, including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.

Apollomics Contacts:

Investor Contact:
Wilson W. Cheung
Chief Financial Officer
(650) 209-4436
wcheung@apollomicsinc.com

U.S. Media Contact:
Remy Bernarda
Corporate Communications
(415) 203-6386
remy.bernarda@apollomicsinc.com

China Media Contact:
Porda Havas International Finance Communications Group
Kelly Fung
General Manager
(852) 3150 6763
kelly.fung@pordahavas.com

Phoenix Fung
Assistant Vice President
(852) 3150 6773
phoenix.fung@pordahavas.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

FOSTER CITY, Calif. and HANGZHOU, China and HOUSTON, Texas, Feb 11, 2021 – (ACN Newswire) – Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and Iterion Therapeutics, Inc., a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, today announced an exclusive collaboration and license agreement for the development and commercialization of tegavivint in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.

Tegavivint is a potent and selective inhibitor of nuclear Beta-catenin that works through binding to TBL1 (Transducin Beta-like Protein One), a downstream target in the Wnt-signaling pathway. Iterion is pursuing the development of Tegavivint for the treatment of cancers where nuclear Beta-catenin signaling is known to play a role. Tegavivint is currently the subject of a Phase 1/2a clinical trial in patients with progressive desmoid tumors.

"As a potent and selective small molecule targeting the Wnt-signaling pathway, Tegavivint is an ideal addition to our clinical development pipeline," said Guo-Liang Yu, Ph.D., Chief Executive Officer of Apollomics. "The preclinical work has demonstrated that the differentiated mechanism of action may be applicable in several indications as both a monotherapy and a combination treatment. We look forward to working with the Iterion team to expand development in Greater China."

Under the terms of the agreement, Apollomics will be responsible for clinical development and commercialization in Greater China. Apollomics and Iterion will form a joint development committee to ensure ongoing collaboration of Tegavivint across indications and geographies. Iterion has received an initial cash payment for ongoing research and development costs in connection with the company's global development of Tegavivint. Iterion is also eligible to receive potential development and sales milestone payments, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development and commercialization activities for Tegavivint in Greater China.

Rahul Aras, Ph.D., President and Chief Executive Officer, Iterion Therapeutics, added, "As we explore multiple indications for Tegavivint in the U.S., including desmoid tumors, acute myeloid leukemia, non-small cell lung cancer, and pediatric cancers, we are excited to partner with Apollomics to expand its development and potential commercialization in Greater China. With Apollomics' oncology focus and growing footprint in China, they are the partner of choice to successfully advance Tegavivint for cancer patients in this region."

About Tegavivint

Tegavivint is a potent and selective inhibitor of nuclear Beta-catenin that binds to TBL1 (Transducin Beta-like Protein One), a downstream target in the Wnt-signaling pathway. Targeting TBL1 may enable specific silencing of Wnt-pathway oncogenic gene expression without affecting other necessary cellular functions that are disrupted when targeting higher up the Wnt-pathway. This avoids toxicity issues common to other drugs in this pathway.

Tegavivint has the potential for clinical utility in multiple cancer types. Tegavivint is currently the subject of a Phase 1/2a clinical trial in progressive desmoid tumors. Desmoid tumors, a rare type of sarcoma for which there is no currently approved therapy, are driven primarily by nuclear Beta-catenin signaling and, thus, present an optimal indication for demonstrating the drug's mechanism of action as the company pursues additional clinical programs. Tegavivint has also demonstrated anti-tumor activity in multiple pre-clinical models, including acute myeloid leukemia (AML) and non-small cell lung cancer (NSCLC).

About Iterion Therapeutics

Iterion Therapeutics is a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics. The company's lead product, Tegavivint, is a potent and selective inhibitor of nuclear Beta-catenin, an oncology target implicated in cell proliferation, differentiation, immune evasion and stem cell renewal. Research demonstrating anti-tumor activity in multiple pre-clinical models indicate that Tegavivint has the potential for clinical utility in multiple cancer types. Tegavivint is currently the subject of a Phase 1/2a clinical trial in patients with progressive desmoid tumors. Iterion is also pursuing development in additional cancers where nuclear Beta-catenin signaling has been shown to play a role, including acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC), and pediatric cancers, including sarcomas, lymphoma and other solid tumors. This research/clinical trial was supported with a $15.9 million grant from the Cancer Prevention & Research Institute of Texas. For more information on Iterion, please visit https://iteriontherapeutics.com.

About Apollomics, Inc.

Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer. The company's existing pipeline consists of several development-stage assets, including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.

Iterion Therapeutics Contact:

Tiberend Strategic Advisors, Inc.
Ingrid Mezo (Media)
646-604-5150
imezo@tiberend.com

Apollomics Contacts:

Investor Contact:
Wilson W. Cheung
Chief Financial Officer
(650) 209-4436
wcheung@apollomicsinc.com

U.S. Media Contact:
Remy Bernarda
Corporate Communications
(415) 203-6386
remy.bernarda@apollomicsinc.com

China Media Contact:
Porda Havas International
Kelly Fung
General Manager
(852) 3150 6763
kelly.fung@pordahavas.com

Phoenix Fung
Assistant Vice President
(852) 3150 6773
phoenix.fung@pordahavas.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

TORONTO, Feb 11, 2021 – (ACN Newswire) – Novamind Inc. (CSE:NM) ("Novamind"), a leading mental health company specialized in psychedelic medicine, is pleased to announce that it has made a strategic investment of AU$827,486 (approximately CAN$810,000, the "Strategic Investment"), in Bionomics Limited ("Bionomics") (ASX:BNO)(OTCQB:BNOEF) (Germany:AU000000BNO5), a biopharmaceutical company dedicated to developing better treatments for central nervous system disorders.

In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210. BNC210 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of post-traumatic stress disorder (PTSD).

With its investment in Bionomics, Novamind joins a group of well-known investors that specialize in psychedelics and biotech: Apeiron Investments, Biotech Value Fund, Merck & Co., Mike Novogratz, and Peter Thiel, an early investor in ATAI Life Sciences.

Novamind's Strategic Investment is included in Bionomics' latest round of financing, which was underwritten by Apeiron Investments and received commitments for AU$16,000,000 (approximately CAN$15,680,000, the "Bionomics Financing"). Novamind will purchase a total of 5,706,800 common shares in the Bionomics Financing, at AU$0.145 per share, a 20% discount to the 30-day volume weighted average price as of February 5th, 2021. Proceeds from the Bionomics Financing will support the initiation of a Phase IIb trial for BNC210, planned for mid-2021.

Bionomics intends to evaluate Cedar Clinical Research's deep expertise in facilitating Phase I to Phase IV clinical trials for leading pharmaceutical companies, and how it may potentially serve as a research site for Bionomics' Phase IIb clinical trial examining BNC210 in PTSD patients.

Cedar Clinical Research, led by Novamind's Chief Medical Officer, Dr. Reid Robison, is currently contracted for seven clinical trials with various sponsors, including leading pharmaceutical companies. Dr. Robison has led over 100 clinical trials in neuropsychiatry, researching a spectrum of psychiatric conditions, including PTSD.

"I'm happy to welcome Novamind as a strategic investor in Bionomics," said Dr. Errol De Souza, Executive Chairman of Bionomics. "Dr. Robison and the team at Cedar Clinical Research have unique experience related to clinical trials for mental health therapeutics."

Yaron Conforti, CEO and Director of Novamind, added, "We are pleased to participate in Bionomics' financing to support the development of its novel drug candidate for the treatment of PTSD. Cedar Clinical Research has unique expertise in PTSD research, and we look forward to the opportunity to contribute to the development of BNC210."

To learn more about Cedar Clinical Research, please visit cedarclinicalresearch.com.

About Bionomics

Bionomics is a global, clinical stage biopharmaceutical company leveraging its proprietary platform technologies to discover and develop a deep pipeline of best in class, novel drug candidates. Bionomics' lead drug candidate BNC210, currently in development for initiation of a second Phase II trial for the treatment of PTSD, is a novel, proprietary negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor. Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc (known as MSD outside the United States and Canada). To learn more, please visit bionomics.com.au.

About Novamind

Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics, retreats, and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of Cedar Psychiatry clinics and operates Cedar Clinical Research, a contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. Both Cedar Psychiatry and Cedar Clinical Research are wholly owned subsidiaries of Novamind. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.

Contact Information
Novamind
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512
Bill Mitoulas, Investor Relations
Email: bill@novamind.ca

Forward-Looking Statements

This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company's expectations including the risks detailed from time to time in the Company's public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.

SOURCE: Novamind Inc.

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com