Kintor Pharma Announces 2021 Business Progress and Annual Results

SUZHOU, China, March 26, 2022 /PRNewswire/ -- Kintor Pharmaceutical Limited (Kintor Pharma, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, today announced business highlights and financial results for the year ended December 31, 2021.

*2021 Annual Results Highlights Overview*

· During the reporting period, Kintor Pharma achieved the zero breakthrough of revenue of RMB34.23 million ($5.38 million), which mainly came from the upfront payments of the out-licensing of proxalutamide.· Kintor Pharma continues to improve the global innovation capacity, which has 2 registered phase III global multi-regional clinical trials greenlighted by the US FDA and 4 innovative drugs under clinical research expanded the international development, and aims to act as the "pioneer" of Chinese innovative drug companies to go overseas.· Kintor Pharma expects to submit the NDA for indications of COVID-19, prostate cancer and androgenetic alopecia this year or next year.· Kintor Pharma completed a top-up placement and raised HK$1.16 billion ($150 million). Only 20% of 18A companies in the market have achieved refinancing after listing*.· The company's stock have been included in many indexes such as the Hang Seng Composite Index (HSCI) and the Hong Kong Stock Connect program, which will help increase the stock's liquidity and expand investors base.· Kintor Pharma has greatly increased its commercial capacity for proxalutamide, with 1 million units/month now and will increase to 50 million units/year by the end of this year.

* Biotech companies that have been listed for less than 6 months and didn't meet the criteria of issuing new shares are excluded.

Dr. Youzhi Tong, founder, Chairman, and CEO of Kintor Pharma commented, "2021 was an extraordinary year for Kintor Pharma. The COVID-19 pandemic continued to be a threat to the global health. We are pleased to see that proxalutamide - a novel drug developed by our team more than a decade ago - might become a critical tool in treating COVID-19 infection and helping stop the pandemic. During the course of the pandemic, we made significant progress in clinical trials confirming the use of proxalutamide to treat COVID-19 infection. We believe our efforts demonstrate our ability to make progress during challenging time, while staying true to our mission of advancing human health.

In 2021, we made breakthroughs in revenue, research and development, production operations, commercial collaborations, as well as funding activities in the Hong Kong capital market.

During the reporting period, the company achieved the zero breakthrough of revenue from out-licensing contracts, which mainly came from the receipt of the upfront payments in connection with the out-licensing of proxalutamide.

Kintor Pharma's products pipeline consists of innovative, small-molecule drugs, biologics, and combination therapies. We have seven novel drug candidates under clinical trials in China, US and other countries. We also have several preclinical projects.

In terms of production operations, we have expanded production capacity at our own GMP factory and appointed Dr. Qun Lu as the company's Chief Technology Officer (CTO) to accelerate proxalutamide's commercialization.

In 2021, Kintor Pharma established partnerships with Hainan Visum Pharmaceutical Limited, Fosun Pharma, PT Etana, XtalPi, and Shanghai Pharmaceutical Co., Ltd. In addition, we appointed Dr. Jiawen Han as vice president of business development to further strengthen the company's business development efforts.

In terms of capital market activities, Kintor Pharma completed a top-up placement and raised proceeds of HK$1.16 billion ($150 million) from reputable long-only funds, healthcare specialist funds, and hedge funds. The funding provides Kintor with substantial financial support. In addition, the company's stock has been included in the Hang Seng Composite Index and Hong Kong Stock Connect.

Looking forward to 2022, Kintor Pharma will continue to make significant progress in its three global multi-regional phase III clinical trials of proxalutamide for the treatment of COVID-19 infection. Also, we will further advance the global clinical development of our existing product pipeline.

In addition, we will continue to strengthen our domestic and international business collaboration to fulfill our mission of "focusing on the research, development, and commercialization of products for diseases with unmet clinical needs." Finally, we will continue our work to benefiting more patients, creating long-term value for shareholders, and improving human health."

*Recent Business Progress Highlights*

Pipeline Progress

Currently, the company has seven products in clinical stage and we continue to make progress in our clinical trials, as described below.

*Proxalutamide（GT0918）*

Proxalutamide is a new generation of androgen receptor (AR) antagonist and ACE2 and TMPRSS2 degrader that is under clinical development for the potential treatment of COVID-19 infection, prostate cancer and breast cancer.

COVID-19

· Results of investigator-initiated trials in Brazil of proxalutamide for the treatment of COVID-19 demonstrated that the compound could effectively inhibit the advance of infection in male and female outpatients (NCT04446429 and NCT04853134) and reduce the risk of hospitalization by 92% and around 90%. The study results also showed that the mortality rate of inpatients (NCT04728802) treated with proxalutamide was 78% lower than that of the control group.· Kintor Pharma is now conducting two registered phase III multi-regional clinical trials (MRCTs) (NCT04870606 and NCT04869228) of proxalutamide for the treatment of COVID-19 outpatients, and one phase III MRCT (NCT05009732) for COVID-19 inpatients in countries and regions that include the US, South America, the EU, and Asia (including China).· On 13 July 2021, Kintor Pharma was granted an emergency use authorization (EUA) for proxalutamide for the treatment of COVID-19 in inpatients in Paraguay. In addition, the Ministry of Health of Canton Sarajevo in Bosnia and Herzegovina has granted EUA for proxalutamide to treat inpatients with COVID-19 infections on January 2022. The Ministry of Health of the Republic of Ghana has granted an authorization for proxalutamide to treat inpatients with COVID-19.· On 27 December 2021, Kintor Pharma announced interim analysis for phase III study of proxalutamide for outpatients (NCT04870606). The statistical criteria was not met due to insufficient number of events, but there were no safety concerns nor drug-related serious adverse events (SAEs) reported during the study.· On 10 February 2022, Kintor Pharma announced the enrollment and dosing of the first patient in China in its multi-regional phase III clinical trial (NCT04869228) of proxalutamide for the treatment of COVID-19 outpatients in the Third People's Hospital of Shenzhen.

Metastatic Castration-Resistant Prostate Cancer

· Kintor Pharma is conducting two phase III clinical trials of proxalutamide. One is a second-line monotherapy for metastatic castration-resistant prostate cancer (mCRPC) in China, the other one is a first-line combo therapy for mCRPC with abiraterone in China.· In February 2021, Kintor Pharma released proxalutamide's phase II clinical trial data in China and its phase II interim data in the US for the treatment of mCRPC patients at American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU).· On 24 February 2022, Kintor Pharma finished enrollment of 718 patients for its phase III clinical trial of a first-line combo therapy of proxalutamide and abiraterone for mCRPC in China.· Kintor Pharma is performing data analysis of the phase II clinical trial of proxalutamide in the treatment for mCRPC in the US.

Androgen Receptor Positive (AR+) Metastatic Breast Cancer

· Kintor Pharma is currently carrying out an open-label phase Ic clinical trial to evaluate the safety, pharmacokinetic characteristics, and initial efficacy of proxalutamide in combination with exemestane, letrozole, and fulvestrant in patients with AR+ metastatic breast cancer. On 25 August 2021, this trial has completed patient enrollment.

Expected Milestones

· Kintor Pharma expects to release top-line results of proxalutamide's phase III study (NCT04870606) for COVID-19 outpatients soon.· Kintor Pharma expects to release proxalutamide's phase III multi-regional clinical trial (NCT04869228) for COVID-19 outpatients interim analysis data in H2 2022.

*Pyrilutamide（KX-826）*

KX-826 is an AR antagonist for external use that is at clinical stage for potential treatment of androgenetic alopecia (AGA) and acne. KX-826 is the first AR antagonist at phase III clinical trial stage for AGA treatment in China and the globe.

Androgenetic Alopecia (AGA)

· For KX-826, Kintor Pharma is now conducting one phase III clinical trial in China and one phase II clinical trial in the US for male AGA patients, and one phase II clinical trial in China for female AGA patients.· On 8 September 2021, Kintor Pharma announced that the phase II clinical trial of KX-826 on male AGA patients in China had met its primary endpoint. Results showed good efficacy and safety profile.· On 31 December 2021, Kintor Pharma announced the first patient dosing in KX-826's phase III clinical trial in China for male AGA.· On 28 February 2022, Kintor Pharma announced the first patient dosing in KX-826's phase II clinical trial in the US for male AGA.· On 4 March 2022, Kintor Pharma announced that KX-826's phase II clinical trial in China for female AGA had completed the enrollment of 160 patients.

Acne

· Kintor Pharma dosed the first patient in KX-826's phase I/II clinical trial of KX-826 in China for acne vulgaris on 16 April 2021 and 24 January 2022 respectively.

Expected Milestones

· Kintor Pharma expects to complete the patient enrollment of KX-826's phase III clinical trial in China for male AGA in H1 2022.· Kintor Pharma expects to complete the patient enrollment of KX-826's phase III clinical trial in China for acne in H1 2022.· Kintor Pharma expects the data of KX-826's phase II clinical trial in China for male AGA will be presented by its PIs in high-profile symposium in June 2022 if the event would not be effected by the pandemic.· Kintor Pharma expects to receive preliminary data of KX-826's phase II clinical trial in China for female AGA in Q4 2022.

*ALK-1 Antibody（GT90001）*

ALK-1 antibody is a new anti-angiogenesis inhibitor that is under clinical development for the treatment of metastatic hepatocellular carcinoma (HCC) and advanced or refractory solid tumors. In 2018, the company obtained an exclusive global license from Pfizer to develop and commercialise ALK-1 antibody for the treatment of metastatic HCC and other oncological indications.

Hepatocellular Carcinoma (HCC)

· Kintor Pharma is carrying out a phase Ib/II clinical trial of ALK-1 antibody and nivolumab (PD-1) for the second-line treatment of metastatic HCC in Taiwan, China. In January 2021, the company announced the Taiwan phase II clinical trial data at ASCO GI. The results showed that treatment with ALK-1 was safe and 40% of patients were observed partial remission.· On 11 February 2021, FDA greenlighted ALK-1 antibody's phase II clinical trial combined with nivolumab for the second-line treatment of advanced HCC.· On 9 October 2021, the clinical trial of ALK-1 antibody (GT90001C)'s combo therapy with nivolumab for advanced HCC patients was approved by the National Medical Products Administration (the "NMPA") of China.

Solid Tumors

· On 2 November 2021, Kintor Pharma had enrolled and dosed its first patient with advanced or refractory solid tumors in a phase Ib/II clinical trial of ALK-1 antibody in combination with KN046, a PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab in Taiwan, China.

Expected Milestones

· Kintor Pharma expects to dose the first patient of ALK-1 antibody's phase II clinical trial combined with nivolumab for the second-line treatment for advanced HCC in the US in H1 2022.

*GT20029*

GT20029 is a PROTAC-AR degrader that is under clinical development for the potential treatment of AGA and acne. Developed by Kintor's proprietary Proteolys is Targeting Chimera (PROTAC) platform, GT20029 is the first topical PROTAC compound that has entered the clinical stage globally.

AGA and Acne

· On 28 July 2021, Kintor Pharma announced that it had dosed the first batch of subjects in its phase I clinical trial of GT20029 in China.· On 1 February 2022, Kintor Pharma announced that it had dosed the first subject for GT20029's phase I clinical trial for the treatment of AGA and acne in the US.

Expected Milestones

· Kintor Pharma expects to complete patient enrollment of GT20029's phase I clinical trial for AGA and acne in China in H1 2022.· Kintor Pharma expects to complete patient enrollment of GT20029's phase I clinical trial for AGA and acne in the US in H2 2022.

*GT90008*

GT90008 is a PD-L1/TGF-β dual-targeting antibody that is under clinical development as a potential treatment of advanced solid tumours.

· On 21 October 2021, the clinical trial of GT90008 for the treatment of advanced solid tumors was approved by the NMPA of China.

Expected Milestones

· Kintor Pharma expects to dose the first patient of GT90008's phase I clinical trial in China in H2 2022.

*Detorsertib（GT0486）*

Detorsertib (GT0486) is a PI3K/mTOR signaling pathway inhibitor that is under clinical development for potential treatment of metastatic solid tumor.

· Kintor Pharma is conducting a phase I clinical trial of GT0486 in the treatment of metastatic solid tumors in China.

*GT1708F*

GT1708F (Hedgehog/SMO inhibitor) is a hedgehog signal transduction pathway inhibitor that is under clinical development for the potential treatment of blood cancer (MDS, CMML, AML) and basal cell carcinoma (BCC).

· Kintor Pharma is conducting the phase I clinical trial of GT1708F for the treatment for blood cancer in China.

In addition to the above clinical-stage drugs, Kintor is developing a variety of pre-clinical drugs, including ALK-1/VEGF bispecific antibody and c-Myc inhibitor.

*Commercial Collaboration*

On 12 April 2021, Kintor Pharma announced that it had entered into a strategic partnership with Hainan Visum Pharmaceutical Limited to expand its production capacity of proxalutamide.

On 15 July 2021, Kintor Pharma announced that it had entered into a licensing agreement with Fosun Pharma Development on the commercialization of proxalutamide for the treatment of COVID-19 in India and 28 African countries. According to the licensing agreement, Fosun Pharma Development would be granted exclusive rights of registration and commercialisation of proxalutamide in the collaboration regions. Kintor Pharma will be eligible to receive upfront payment and milestone payments up to RMB560million (upfront and development milestone payments up to RMB110 million and commercialisation milestone payments of RMB450 million). Kintor Pharma will also be eligible to receive royalty payments that are not less than 50% of the total operating profit in the collaboration regions, based on a tiered structure per the amount of net sales as agreed by both companies.

On 25 August 2021, Kintor Pharma announced it had partnered with PT Etana to commercialize proxalutamide for COVID-19 infection in Indonesia. Pursuant to the Licensing Agreement, Kintor Pharma will receive from Etana upfront and milestone payments, in addition to the economic benefit relating to the sales from the launch of proxalutamide in Indonesia.

On 7 September 2021, Kintor Pharma announced a drug discovery partnership with AI-biotech XtalPi. Kintor plans to use XtalPi's artificial intelligence-based drug discovery platform to discover and develop anti-tumor monoclonal antibody drugs.

On 16 December 2021, Kintor Pharma and Shanghai Pharmaceutical Co.,Ltd., signed a strategic cooperation agreement.

*Production Operation*

· Kintor Pharma's Suzhou site passed a European drug Qualified Person audit (QP audit)· Kintor Pharma set up a tincture and gel production line and obtained the drug production license.· Kintor Pharma has greatly increased its commercial capacity for proxalutamide, with 1 million units/month now and will increase to 50 million units/year by the end of this year.· On April 2021, Kintor Pharma announced that it had expanded its geographical presence to Zhuhai, Guangdong Province ("Zhuhai office"). The new office is located at Zhuhai International Health Port, Jinwan District. The role of the Zhuhai office is to speed up the clinical R&D, production, and commercialization of biological drugs.· Kintor Pharma's Pinghu(Zhejiang Province) site covers an area of 40,000 square meters. We are going to build manufacturing facilities of APIs and final products for proxalutamide and pyrilutamide. The construction is expected to start in Q2 2022.

*Performance in Capital Market*

· On 2 June 2021, Kintor Pharma completed a top-up placement and raised HK$1.16 billion ($150 million) from reputable long-only funds, healthcare specialist funds and hedge funds.· On 6 September 2021, Kintor Pharma stock was included in the Hang Seng Composite Index (HSCI) and the Hong Kong Stock Connect program, which will increase the stock's liquidity and expand the investors base.

*Other News*

· On 9 April 2021, Kintor Pharma announced two poster presentations of preclinical data at the American Association for Cancer Research (AACR) Annual Meeting 2021, including proxalutamide to treat COVID-19 and a c-Myc inhibitor to treat blood cancer.· On 16 May 2021, Kintor Pharma announced the appointment of Dr. Qun Lu as the Chief Technology Officer (CTO) and Dr. Jiawen Han as Vice President of Business Development. Dr. Lu will be primarily responsible for Chemistry, Manufacturing, and Control ("CMC"), including drug analysis, formulation development, and production. And Dr. Han will be primarily responsible for business development-related projects and management.· On 19 October 2021, Dr. Youzhi Tong was invited to join the symposium organized by Vice Premier Minister Ms. Chunlan Sun and introduced the progress of the proxalutamide for the treatment of COVID-19.· On 8 November 2021, Indonesian Ambassador to China, H.E. Djauhari Oratmangun, Indonesian Consul General in Shanghai, Mr. Deny Wachyudi Kurnia, and the Chairman of the Indonesia Chamber of Commerce in China, Mr. Liky Sutikno, visited Kintor Pharma for in-depth understanding of the company.

*2021 Annual Financial Performance**

Kintor Pharma started to generate revenue with a total amount of RMB34.23 million（$5.38 million）for the reporting period, which was from the receipt of the upfront payments of proxalutamide's COVID-19 indication out-licensing.

As of December 31, 2021, the company's research and development costs increased by RMB769.7 million ($120.99 million), up by 133.5%, from RMB328.8 million ($51.69 million) ended December 31, 2021. The main reason for the increase in R&D expenditure is that the company initiated and conducted three phase III multi-regional trials of proxalutamide for the COVID-19 infection during the reporting period.

As of December 31, 2021, the company's cash and cash equivalents and time deposits amounted to RMB1055.2 million($165.59 million), utilised bank facilities of RMB154.9 million ($24.35 million). In addition, the company also had unutilised bank facilities of RMB150 million ($23.58 million) as at 31 December 2021.

*According to today's exchange rate.