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Jacobio Announces Annual Results of 2021, R&D Investment Increases 83%

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[Abstract]:
Reveune was RMB152 million, R&D investment was RMB421 million.

BEIJING and SHANGHAI and BOSTON, March 22, 2022 /PRNewswire/ -- Jacobio Announced its 2021 annual results on 22 March. As a clinical-stage biotech company, Jacobio's revenue was RMB152 million, which was generated from an out-licensing deal. Its R&D investment was RMB421 million, showing an increase of 83% compared with 2021.

"83% growth was built on an impressive 66% increase in 2020, Jacobio will continuously increase its R&D investments. Jacobio's pipeline revolves around six major cancer signaling pathways (RAS, MYC, RB, I/O, tumor metabolic, P53). Several pre-clinical stage programs will submit IND (investigational new drug) applications in one or two years as one of the first three among its same target globally. By then, Jacobio will further achieve its strategic goal of 'core programs will be one of global first three,'" says Dr. Yinxiang WANG, Chairman and CEO of Jacobio.

Clinical stage programs such as SHP2 and KRAS G12C has advanced efficiently

Jacobio remains a global leader in SHP2 inhibitors (JAB-3068, JAB-3312). JAB-3312 has finished phase I clinical study and determined recommended dose of monotherapy and combination therapy with PD-1 antibody. Now, JAB-3312 is in the phase II stage to explore efficacy.

Simultaneously, Jacobio has started phase I/II studies for combinations of SHP2 with Sotorasib and Osimertinib in the U.S. Jacobio plans to fully explore SHP2 inhibitors for indications and efficacy in 2022. The 2021 revenue was RMB152 million, generated from the out-licensing fee of SHP2 inhibitors' partnership with AbbVie.

KRAS G12C inhibitor (JAB-21822) has been advanced efficiently, and the whole process from submitting an IND application to confirming the recommended dose of phase II has been completed in the past year. Most of the trial participants benefited from the treatment of the clinical trials with the efficacy shown to be long-lasting.

JAB-21822 has received four IND approvals, including three combo therapy trials combining the SHP2 inhibitor JAB-3312, cetuximab and PD-1 antibody respectively, and a monotherapy trial for STK-11 co-mutation in lung cancer. The trial combining KRAS G12C with Cetuximab for colorectal cancer has already enrolled patients.

Outside of China and the United States, JAB-21822 has been approved for clinical trials in Spain, Poland, and Israel, and more clinical trials will be launched in Europe and other regions in the future.

In addition to the SHP2 inhibitors and KRAS G12C inhibitor, Jacobio has three clinical-stage programs, among which the BET inhibitor (JAB-8263) has completed the first patient dosing in two trials in China. CD73 (JAB-BX102) and Aurora A (JAB-2485) both received IND approvals from the US Food and Drug Administration in 2021, and patients are planned to be enrolled in the second and third quarters of 2022.

Future outlook: 6-8 programs have the potential to be among the first three globally, transforming into a biopharma company

SHP2 and Aurora A inhibitors in Jacobio's pipeline are among the first three products in their categories in the world to have entered the clinical stage. There are seven preclinical programs of Jacobio that are all new targets and are expected to submit IND applications as one of the first three globally.

These include JAB-24114 (an undisclosed target in tumor metabolic pathway), JAB-BX300 (an undisclosed target in the RAS pathway), which is scheduled to submit an IND application in 2022, and JAB-26766, which is scheduled to submit an IND application during 2022 to 2023 (undisclosed target of I/O pathway). JAB-23400 (KRASmulti inhibitor), JAB-22000 (KRAS G12D inhibitor), JAB-23000 (KRAS G12V inhibitor), JAB-30000 (P53 inhibitor) will submit IND applications during 2023 to 2024. At that time, Jacobio may have 6-8 projects, which will enter the clinical stage at the speed of one of the first three in the world, and further achieve Jacobio's strategic goal of "core programs will be one of global first three."

In 2023, Jacobio will transform from a biotech company to a biopharma company. Jacobio will submit a registrational clinical trial application for KRAS G12C inhibitor (JAB-21822) in China in 2022 and is expected to submit a New Drug Application (NDA) during 2023 to 2024, which means that Jacobio is getting closer to commercialization. At the same time, the 20,000-square-meter R&D and GMP centre in Beijing has been capped and will be officially put into use at the end of 2022, which indicates that the company will gradually have the manufacturing capacity and gradually become a company that integrates R&D, manufacture and sales.

Conference Call Information

Jacobio will host a conference call on March 23, 2023, at 9:00-10:00 (HKT)

Participants must register in advance of the conference call. Details are as follows:

Registration Link: https://goldmansachs.zoom.us/webinar/register/WN_D8ceo4NUR3udIE1LSXBHNQ

About Jacobio

Jacobio is committed to providing more products and solutions to people's health. Our mission is to provide compelling innovations for creating a pipeline of life-changing medicines. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. The company's R&D centers are located in Beijing, Shanghai and MA, with a platform and expertise in developing allosteric inhibitors against protein tyrosine phosphatase, KRAS and transcriptional factors.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to the Company, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment, and political, economic, legal and social conditions in China.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.