BioInvent International : 26/08/2021 BioInvent Interim Report, January 1 - June 30, 2021

Q2

INTERIM REPORT JANUARY 1 - JUNE 30, 2021

CEO Martin Welschof on the new agreement with Merck:

"We are very pleased we have reached a second collaboration with MSD (Merck) that supports the expansion of the ongoing clinical trial program with our anti-TNFR2 antibody BI-1808. We are excited about the potential synergistic activity of BI-1808 in combination with pembrolizumab and this agreement supports the strong interest elicited by our broadening pipeline of anti-cancer antibodies."

Events in the quarter

• BioInvent received IND approval for Phase 1/2a trial of anti-TNFR2 antibody BI-1808.
• BioInvent and Transgene received IND approval from the U.S. FDA for BT-001, a novel oncolytic virus delivering an anti-CTLA-4 antibody for the treatment of solid tumors.
• BioInvent received notice of allowance in China for the anti-FcγRllB antibody BI-1206 patent.

Events after the period

• (R) BioInvent announced a second clinical trial collaboration and supply agreement with Merck to evaluate BI-1808 in combination with Keytruda® (pembrolizumab) in patients with advanced solid tumors

Financial information

SECOND QUARTER 2021

•

•

•

•

Net sales SEK 5.3 (15.6) million.

Loss after tax SEK -57.3(-39.3) million.

Loss after tax per share before and after dilution SEK -0.98(-2.00).

Cash flow from operating activities and investment activities SEK -65.9(-28.4) million.

JANUARY - JUNE 2021

•

•

•

•

•

Net sales SEK 11.5 (32.4) million.

Loss after tax SEK -137.1(-72.0) million.

Loss after tax per share before and after dilution SEK -2.75(-3.50).

Cash flow from operating activities and investment activities SEK -117.4(-63.9) million. Liquid funds as of June 30, 2021: SEK 1,509.7 (182.3) million.

(R)= Regulatory event

This information is such information as BioInvent International AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out on page 22, at 8:00 a.m. CEST on August 26, 2021.

"BioInvent has continued to deliver impressive clinical progress across the pipeline in the second quarter, underpinned by a solid financial position following a successful financing in February which ensures funding through significant value- creating clinical milestones."

CEO Martin Welschof comments the quarter

Impressive clinical progress, built on a solid financial foundation

BioInvent has continued to deliver impressive clinical progress across the pipeline in the second quarter, underpinned by a solid financial position following a successful financing in February, which ensures funding through significant value-creating clinical milestones. We now have four programs moving through clinical trials and expect to file for approval to start a fifth by the end the year.

IND APPROVAL FOR BI-1808 AND BT-001

The U.S. Food and Drug Administration (FDA) has approved our Investigational New Drug (IND) application for the Phase 1/2a clinical study of the immuno-modulatoryanti-TNFR2 antibody BI-1808. This is another important milestone as we continue to broaden our exciting pipeline of anti-cancer anti- bodies. Recruitment is proceeding very well, with no negative impact from Covid-19. The study is assessing BI-1808 first as

• single agent, and then in combination with the anti-PD-1 therapy Keytruda® in patients with ovarian cancer, non-small cell lung cancer and CTCL. We are excited about the potential synergistic activity of BI-1808 in combination with pembroli- zumab and in early August we were pleased to announce a second clinical trial collaboration and trial agreement with Merck, giving us access to Keytruda® for the continued clinical development of BI-1808.

Together with our partner Transgene, we have received FDA approval of our IND application for BT-001, enabling patients in the U.S. to be enrolled into the ongoing Phase 1/2a clinical trial of BT-001. This oncolytic virus delivers an anti-CTLA-4 antibody which releases the brakes of the immune system, inducing anti-cancer immune activation in the solid tumor environment and ensuring a low systemic exposure in the rest of the body. Recruitment into the trial, assessing BT-001 as a single agent and in combination with pembrolizumab against solid tumors, is progressing very well.

BI-1206 PHASE 2A PART EXPECTED TO START H2 2021

The Phase 1/2a trial of the novel anti-FcγRIIB antibody BI- 1206, in combination with rituximab in non-Hodgkin's lym- phoma (NHL), is advancing as planned. Following the positive interim results, announced in January, selection of the recommended Phase 2a dose and expansion into the Phase 2a part of the study are expected during the second half of 2021.

We expect a clinical update on the second ongoing Phase 1/2a trial with BI-1206, in combination with the anti-PD-1 therapy Keytruda® for patients with solid tumors, by the end of the year.

FOUR ONGOING CLINICAL PROGRAMS

With the initiation of the BI-1808 and BT-001 studies, and continuing progress with BI-1206, BioInvent now has four ongoing clinical programs. In addition, the anti-FcγRIIB antibody BI-1607 is on track for a Clinical Trial Authorization (CTA) submission by the end of this year, further broadening our pipeline of promising immuno-oncology drug candidates.

WELL-FUNDED FOR CONTINUED VALUE CREATION

To support the advancement of these clinical projects, we have added expertise in clinical operations, management and regulatory affairs, as well as strengthened our manufacturing. Our financial position remains strong, following the directed share issue in February which raised SEK 962 million (USD 116 million). This means we are comfortably funded through

• number of important value-creating clinical milestones, which could be triggers for potential partnership agreements for our drug candidates.

We have continued to be active in the scientific community and attending relevant scientific conferences. In May, our CSO Björn Frendéus spoke with the major industry publication Pharmafile about innovative immuno-oncology developments and how combination therapies can support cancer patients across the world - an article you can read here.

We are looking forward to continuing to deliver and I look forward to speaking with you again soon.

BIOINVENT INTERNATIONAL AB (PUBL) - INTERIM REPORT JANUARY 1 - JUNE 30, 2021

PAGE 2

Pipeline with four clinical programs.

BioInvent is focused on developing novel immuno-modulatory antibodies for cancer therapy. BioInvent's innovative antibodies may significantly improve the efficacy of currently available checkpoint inhibitor and/ or activate anti-cancer immunity in currently non-responding patients.

Program

Indication

Discovery

Preclinical

Phase 1

Phase 2

Partner

Target: FcyRIIB

BI-1206/rituximab

NHL (MCL, MZL, iFL)

BI-1206/pembrolizumab

Solid tumors

BI-1607

Solid tumors

Target: CTLA-4 and TNFR2

BT-001(CTLA-4,GM-CSF)

Solid tumors

BI-1808 (TNFR2)

Solid tumors

BI-1910 (TNFR2)

Solid tumors

Discovery.

At BioInvent, we combine deep immunological understanding with target agnostic screening (the target structure is identified only when functional activity is verified) to identify the clinically most relevant targets and antibodies for cancer immunotherapy. Patient tissue, alongside our F.I.R.S.T™ technology platform and the human antibody library n-CoDeR®, are cornerstones in this process.

TECHNOLOGY PLATFORMS

The unique development tool F.I.R.S.T™, where patient material is the foundation throughout the development process, simultaneously identifies the clinically most relevant targets in a disease model and matching antibodies. The proprietary antibody library n-CoDeR® contains antibodies that bind specifically and strongly to their targets.

TUMOR-ASSOCIATED MYELOID CELLS (TAM)

Myeloid cells are a key part of our innate, non-specific, immune system but can also be "hijacked" by tumors to support the growth and spread of cancer. Antibody-mediated "reprogramming" of immunosuppressive tumor-associated myeloid cells (TAMs) to become effector cells that can help to eliminate cancer cells is an attractive therapy concept and a field of research where BioInvent and its partners are at the forefront.

BioInvent has so far received USD 6.6 million in milestone payments besides research funding for an R&D collaboration

with Pfizer 2017-2020 on the selection of TAM targets. Pfizer has selected its targets and BioInvent is eligble for potential future development milestones in excess of USD 100 million if one antibody is developed through to commercialization, and up to double digit royalties on future sales.

REGULATORY T CELLS (TREGS)

Normally, Tregs suppress undesirable activation of the immune system, but unfortunately also enable tumors to evade the body's immune system in cancer. There are many publications showing a clear correlation between the number of Tregs in cancer patients and poor prognosis.

BioInvent is developing antibodies specifically targeting regulatory T cells and tumor-associated myeloid cells, both of which are strongly immunosuppressive, with the aim to deplete or re-educate these cells for enhanced immune-mediated cancer rejection.

BIOINVENT INTERNATIONAL AB (PUBL) - INTERIM REPORT JANUARY 1 - JUNE 30, 2021

PAGE 3

Clinical programs

BioInvent's team has put together one of the most exciting and unique cancer im- munotherapy pipelines of any European biotech company. A solid scientific under- standing, a sharp clinical development strategy and a robust capacity to execute plans have put the company in a very interesting track to develop innovative treatments capable of transforming the life of cancer patients. That's our goal.

To meet our advancing clinical portfolio, we have strengthend our clinical and regulatory expertise with the addition of Mona Welschof and Olga Björklund who both have a long-standing experience from their respective areas of expertise.

Andres McAllister

Chief Medical Officer

Mona Welschof, PhD

VP Clinical Development

Mona Welschof joined the BioInvent team in January 2021. Mona has 20 years of clinical development experience in oncology covering all phases from

early stage to registration.

Olga Björklund, PhD

Regulatory Affairs Director

Olga Björklund joined BioInvent as Regulatory Affairs Director in August 2021. Olga is a pharmacist by training with PhD in neuromolecular­ pharmacology and has worked within global

Regulatory Affairs since 2009.

"My main focus is to support the planning and execution of BioInvent's clinical studies, including coordination and leadership of clinical operations functions, ensuring GCP compliance and providing strategic guidance in clinical development activities. BioInvent is in a very exciting position right now with four clinical projects, and important partners, who all share our ambition to make a real difference for cancer patients."

"I was excited to join Bioinvent having learnt about the novelty of the candidate drugs and their potential to really make a difference in the treatment of a number of cancer therapies. For any regulatory strategist it is a dream to be a part of the team that is driving through the development of novel therapies and have the opportunity to interact with regulatory authorities to ensure timely and optimal deve- lopment."

BI-1206 is a high-affinity monoclonal antibody that selectivity binds to FcγRIIB (CD32B), the only inhibitory member of the FcγR family. FcγRIIB is overexpressed in several forms of NHL and overexpression has been associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma. By blocking FcγRIIB, BI-1206 is expected

to recover and enhance the activity of rituximab or other anti-CD20 monoclonal antibodies in the treatment of these diseases. The combination of the two drugs could provide a new and important option for patients suffering from NHL and represents a substantial commercial opportunity.

BI-1206 in non-Hodgkin's lymphoma.

Target: FcyRIIB

Status: Phase 1

Partner: CASI Pharmaceuticals, Inc.

PROJECT STATUS AND OUTLOOK

Strategically important patent approval

In June 2021, the China National Intellectual Property Administration (CNIPA) issued a notice of allowance, informing the company that a patent application relating to BI-1206 is granted.

This patent allowance is a strategic milestone in BioInvent's exclusive licensing agreement with CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company with an established clinical development and commercial infrastructure in China. In 2020, CASI gained the rights for the development and commercialization of BI-1206 in China and associated markets.

Other patents in the same patent family have already been granted by the European Patent Office and in several other countries, including the US and Japan. The company also has related patent applications pending in some countries.

Positive data from Phase 1/2a study

In January 2021, positive data was presented from the ongoing clinical Phase 1/2a study (NCT03571568) of BI-1206 in

combination with rituximab for the treatment of non-Hod- gkin's lymphoma (NHL). Data suggest that BI-1206 restores activity of rituximab in relapsed NHL patients.

Study design

The Phase 1/2a study is divided into two parts: 1) Phase 1, with dose escalation cohorts using a 3+3 dose-escalation design and selection of the recommended Phase 2a dose (RP2D); and 2) Phase 2a, an expansion cohort at the RP2D, enriched with patients with mantle cell lymphoma (MCL). Patients in each phase receive 1 cycle (4 doses) of induction therapy with BI-1206 in combination with rituximab. Those who show clinical benefit at week 6 continue onto maintenance therapy and receive BI-1206 and rituximab once every 8 weeks for up to 6 maintenance cycles, or up to 1 year from first dose of BI-1206.

Next milestone expected H2, 2021

The next milestone in the project is determination of the recommended Phase 2 dose (RP2D) and progression to the expansion Phase 2a part of the study, expected H2 2021.

OUT-LICENSING AND PARTNERING

Since October 2020, BioInvent has a licensing agreement in place with CASI Pharmaceuticals for Greater China region. Under the terms of the agreement, BioInvent and CASI will develop BI-1206 in both hematological and solid cancers, with CASI responsible for commercialization in China and associ-

ated markets. BioInvent received USD 12 million upfront in combination of cash and equity investment and eligible to receive up to USD 83 million in milestone payments, plus tiered royalties.

BIOINVENT INTERNATIONAL AB (PUBL) - INTERIM REPORT JANUARY 1 - JUNE 30, 2021

PAGE 5