Deck Pharmaceuticals Announces 2020 Annual Results Progress

In January 2021, the company submitted an IND application for the Phase I clinical trial of ATG-019 for the treatment of solid tumors and lymphoma to NMPA
.

ATG-017 (ERK1/2 inhibitor)

Progress during the reporting period

A phase I clinical trial of ATG-017 for the treatment of advanced solid tumors and hematomas completed the first patient administration in Australia
.

ATG-016 (eltanexor, second-generation XPO1 inhibitor)

Progress during the reporting period

A phase I/II clinical trial of ATG-016 for the treatment of myelodysplastic syndrome (MDS) was approved by NMPA
.

Progress after the reporting period

In February 2021, the company submitted an IND application for the Phase I/II clinical trial of ATG-016 for the treatment of solid tumors to NMPA
.

Preclinical drugs

The company is steadily advancing the development of preclinical drugs, including ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-018 (ATR inhibitor), ATG-022 (Claudin 18.
2 antibody drug conjugate), ATG-012 (KRAS inhibitor) and the other two biological drugs with undisclosed targets
.

Progress during the reporting period

• ATG-101 (PD-L1/4-1BB bispecific antibody)

ATG-101 is currently undergoing a new drug clinical application study to support IND/CTA applications.
The company plans to submit an application in 2021
.

• ATG-018 (ATR inhibitor)

ATG-018 is undergoing preclinical research to support IND/CTA applications, and the company plans to submit the application in early 2022
.

• ATG-022 (Claudin 18.
  2 Antibody Drug Conjugate)

ATG-022 is undergoing preclinical research to support IND/CTA applications, and the company plans to submit the application in 2022
.

• ATG-012 (KRAS inhibitor)

ATG-012 is undergoing preclinical research to support IND/CTA applications, and the company plans to submit the application in 2022
.

Other business progress

Progress during the reporting period

• The company appointed Mr.
  John F.
  Chin as the chief commercial officer, responsible for the company’s global business development; appointed Mr.
  Thomas Karalis as the head of the Asia-Pacific market, responsible for the commercialization of the company’s products in Taiwan, Hong Kong, Australia, New Zealand, South Korea and other Asia-Pacific markets ; Appointed Dr.
  Zhinuan Yu as the vice president of the Biostatistics and Regulatory Development Group, responsible for the data statistics and regulatory registration strategy of the pipeline project; appointed Mr.
  Dirk Hoenemann as the vice president and head of early clinical research and development and medical affairs in the Asia-Pacific region
  .
  

• In May 2020, the company further strengthened its cooperation with Karyopharm Therapeutics Inc.
  and obtained selinexor, eltanexor, verdinexor and ATG-019 production and commercialization rights in multiple Asia-Pacific markets
  .
  

• In August 2020, the company signed an agreement with the Management Committee of Shaoxing Binhai New Area to obtain a production base of approximately 16,300 square meters for the commercial production of small molecule drugs
  .
  

• In October 2020, Deqi New Drug R&D Center was officially opened in Zhangjiang, Shanghai
  .
  

• On November 20, 2020, Deqi Pharmaceuticals was successfully listed on the Hong Kong Stock Exchange
  .
  

• As of December 31, 2020, the company has submitted 8 patent applications in China
  .
  

Progress after the reporting period

• In March 2021, Deqi Pharmaceutical was included in nine benchmark and thematic indexes including the Hang Seng Composite Index
  .
  Based on the results of this adjustment, the company is included in the Shenzhen-Hong Kong Stock Connect, which will take effect on March 15, 2021
  .
  

• In March 2021, the company appointed Mr.
  Kevin Lynch as its chief medical officer, responsible for the company's medical affairs and clinical research management and strategy formulation; Dr.
  Shan Bo was appointed as its chief scientific officer, responsible for the company's early R&D and CMC management and strategy formulation
  .
  

Financial summary

Non-IFRS measurement:

The adjusted loss for the year ended December 31, 2020 was RMB 455.
0 million, which was mainly due to the increase in research and development expenses and administrative expenses
.

IFRS measurement:

The company's cash and bank balances for the year ended December 31, 2020 were RMB 3,109.
8 million, an increase of RMB 2,363.
0 million, mainly due to the Series C financing in July 2020 and the initial public offering in November
.

The company's research and development costs for the year ended December 31, 2020 were RMB 347.
7 million, an increase of RMB 231.
9 million, mainly due to the increase in payments to authorized partners and the expansion of research and development personnel and other clinical-related expenses
.

The company's administrative expenses for the year ended December 31, 2020 were RMB 154.
2 million, an increase of RMB 114.
9 million, mainly due to the increase in employee costs and the company's initial public offering (IPO) related share issuance expenses
.

For the year ended December 31, 2020, in accordance with the provisions of the International Financial Reporting Standards, the fair value of convertible redeemable preferred shares has undergone a non-cash one-time change of RMB 2,356.
3 million, an increase of RMB 2,141.
8 million, which is mainly attributable to The fair value per share increased significantly when the convertible redeemable preferred shares previously issued to investors were remeasured after the Company completed the initial public offering
.

The company's other income and income for the year ended December 31, 2020 was RMB 26.
8 million, a decrease of RMB 26.
1 million, mainly due to the lack of net foreign exchange earnings in 2019
.

The company's total loss and comprehensive loss for the year ended December 31, 2020 was RMB 2,928.
9 million, an increase of RMB 2,605.
1 million
.
The increase was due to the following factors (i) The loss increased by RMB 463.
3 million, which was mainly due to the increase in research and development costs and administrative expenses
.
(ii) The non-cash one-off change in the fair value of the converted redeemable preferred shares increased by RMB 2,141.
8 million, which was a non-cash one-off adjustment after listing in accordance with the requirements of the International Financial Reporting Standards
.

   Outlook

Relying on the "combined and complementary" R&D strategy, first-class R&D capabilities and strategic positioning of developing innovative anti-tumor therapies, Deqi will focus on the development, research and commercialization of the first, unique and best-in-class therapy in its class.
Improve the living standards of patients and realize the vision of "Doctors have no boundaries, innovation and sustainability"
.

The company will continue to promote the clinical research of six clinical drugs in multiple therapeutic areas, continue to implement the dual-engine-driven strategy of "independent research and development + cooperative introduction", relying on clinical, business operations and commercialization teams throughout the Asia-Pacific and even the world, aiming at key Carcinogenic pathways, tumor microenvironment and tumor-associated antigens to establish a product pipeline
.
Deqi will always implement complementary development strategies to explore the clinical applications of imported products in other therapeutic fields and maximize its commercial potential
.

Looking ahead to 2021, the company expects to obtain selinexor (ATG-010) listing approval in five Asia-Pacific markets from the fourth quarter of 2021 to the first quarter of 2022, including mainland China, Hong Kong, Australia, South Korea and Singapore
.
At the same time, the company will submit IND applications for two preclinical drugs
.

Deqi's commercialization leadership team has successfully launched blockbuster hematoma products in China, Asia Pacific and even the world many times
.
In order to welcome the first listing of ATG-010 in Greater China and some Asia-Pacific regions, Deqi is also simultaneously building a commercialization team to address the unmet clinical needs of the listed regions
.
It is expected that in 2021, the company will build a commercialization team with outstanding track record and rich regional experience in the field of hematoma, including functions such as marketing, medical promotion, pricing, market access and medical affairs, and the scale of the commercialization team Will reach about 150 people
.