Active Biotech : Interim Report Jan-Jun 2021

Q1 Q2 Q3 Q4

INTERIM REPORT Q2 2021 | ACTIVE BIOTECH AB

Good progress in the projects towards important clinical events

SECOND QUARTER IN BRIEF

• Active Biotech and NeoTX announce FDA clearance of IND for phase II clinical trial of naptumomab

EVENTS AFTER THE END OF THE PERIOD

• Active Biotech provided status update on the progress in its clinical naptumomab project
• Active Biotech's partner NeoTX hosted KOL webinar on overcoming checkpoint inhibitor resistance, featuring combination with naptumomab as one approach

FINANCIAL SUMMARY

	Apr-Jun		Jan-Jun		Full-year
SEK M	2021	2020	2021	2020	2020
Net sales	-	-	-	0.5	6.7
Operating profit/loss	-12.6	-10.1	-22.4	-19.9	-32.3
Profit/loss after tax	-12.6	-9.8	-22.4	-19.9	-32.2
Earnings per share (SEK)	-0.06	-0.06	-0.11	-0.12	-0.19
Cash and cash equivalents (at close of period)			78.5	38.2	26.2

The report is also available at www.activebiotech.com

Active Biotech is obligated to make public the information contained in this report pursuant to the EU Market Abuse Regulation and the Swedish Securities Market Act. This information was provided to the media, through the agency of the contact person set out above, for publication on August 5, 2021, at 08.30 a.m. CET.

Active Biotech AB (Corp. reg. no. 556223-9227) / Scheelevägen 22, SE-223 63 Lund / [phone] / www.activebiotech.com

Helén Tuvesson, CEO: [phone] / Hans Kolam, CFO: [phone]

INTERIM REPORT Q2 2021 | ACTIVE BIOTECH AB

Helén Tuvesson

CEO



We are now one step closer to the first results in the tasquinimod study in multiple myeloma

COMMENTS FROM THE CEO

The projects progressed well during the quarter. Activities were focused on preparations for the next step in our clinical program with tasquinimod, where we expect to review the first safety results in the ongoing study in multiple myeloma during the fall, as well as preparations for the start of clinical development of laquinimod.

In the naptumomab project, which we develop together with our partner NeoTX, the phase Ib/II study in combination with checkpoint inhibition in patients with advanced solid tumors is ongoing. The study is enrolling to the extended dose escalation part, including pre-treatment with the B-cell therapy Obinutuzumab. The results so far indicate that the pre-treatment successfully lower the levels of anti-drug antibodies (ADA) to naptumomab, which is a promising sign in this initial study. We will update when further results from the phase Ib study are available. For more information about the study, see clinicaltrials.gov: NCT03983954. Preparations are ongoing for start of cohort expansions and phase II studies including the previously communicated phase II study in combination with docetaxel in patients with non-small cell lung

cancer (NCT04880863T).

On July 14 NeoTX hosted a KOL event with the focus on overcoming checkpoint inhibitor resistance. Despite the broad activity of these treatments demonstrated across various cancers demonstrated, there is a significant proportion of patients with insufficient treatment response. Preclinical data show monotherapy effect of naptumomab and synergy with checkpoint inhibitors, chemotherapy as well as CAR-T-cell treatment, which indicates the potential of naptumomab in combinations to overcome treatment resistance to a broad range of marketed cancer therapies. Please visit www.neotx.comto view the recorded KOL webinar.

In the phase Ib/IIa study with tasquinimod in multiple myeloma, recruitment to the monotherapy part is ongoing, and we expect to report the first results from the dose escalation with single agent tasquinimod later during the fall. We work continuously to optimize our patent portfolio to secure the best possible protection for the project in the most important markets. In addition to granted medical use patents for tasquinimod in multiple myeloma, we have strengthened our patent portfolio with a patent application for the use of tasquinimod in combination therapy, which may provide an extension of the patent protection until 2041.

We have initiated a collaboration with an academic group in Vrije Universiteit Brussel, Belgium, to further study tasquinimod in the preclinical setting of multiple myeloma. The results established validate the effect of tasquinimod in animal models of the disease reported from the Wistar Institute at the University of Pennsylvania and provide a deeper understanding of mechanisms involved. We will report on these results as the collaboration progresses.

During the spring, we initiated a complementary pre-clinical program of safety studies with laquinimod to bridge between the existing documentation for oral treatment and treatment with the newly developed eye drop formulation. For these pre-clinical studies, as well as for the upcoming clinical phase I study to evaluate the safety of the formulation in healthy subjects, we work with CROs,

2

INTERIM REPORT Q2 2021 | ACTIVE BIOTECH AB

specialized in development of ophthalmological treatments. We expect to be able to start the phase I study during the second half of this year.

On 4 August we decided to pursue a merged phase II study in patients with uveitis, testing oral and topical treatment of laquinimod in the same study, instead of in two separate trials. This approach will increase trial efficiency as well as enable a direct comparison of the two potential treatment options.

The merged phase II study will commence once the clinical phase I trial with the eye drop formulation has been completed. Uveitis is a rare disease with relatively few patients, hence there are clear coordination gains from studying the two forms of administration in the same trial. We currently expect to be able to start the combined oral and topical trial early 2023.

Recently, we received a notice of allowance for our patent application US 15/816,402 covering treatment of ocular inflammatory diseases, including uveitis, using laquinimod. We have also broadened our patent protection for the use of laquinimod in eye disorders associated with excessive neovascularization with an international patent application (WO 2021/123142). This application provides a potential to protect laquinimod in this field of use until 2040.

The business is advancing across our development projects and with the first half of the year behind us, we are now one step closer to the first results in the tasquinimod study in multiple myeloma

and start of clinical development with laquinimod. We continue to carefully monitor the impact of the Covid-19 pandemic and take every precaution to ensure that staff, collaborators, and study participants are safe and stay well, while progressing our clinical studies with high data quality. I look forward with confidence to an exciting next six months and to relay news to you around the progress of our clinical programs.

Helén Tuvesson, CEO

3

INTERIM REPORT Q2 2021 | ACTIVE BIOTECH AB

PROJECTS

Active Biotech's project portfolio includes projects for the development of drugs for the treatment of cancer and inflammatory diseases.

Disease Area	Discovery	Preclinical	Phase I	Phase II	Phase III	Partner
Cancer	Naptumomab Combination with anti-PDL1 (durvalumab) in solid tumors
	Naptumomab Combination with docetaxel in Non-small cell lung cancer*
	Tasquinimod Multiple myeloma**
Inflammation	Laquinimod Uveitis
	Study ongoing
	Preclinical activities ongoing
	* Study preparations ongoing
	** In an academic partnership with the Abramson Cancer Center, Philadelphia, University of Pennsylvania

Naptumomab estafenatox

Naptumomab estafenatox (naptumomab) is a tumor targeting immunotherapy that enhances the ability of the immune system to recognize and kill the tumor. Since October 2016, Active Biotech has a licensing agreement with NeoTX Therapeutics Ltd (NeoTX) for the worldwide development and commercialization of naptumomab for cancer therapy.

Naptumomab increases the immune system's ability to recognize and attack the tumor, and preclinical data from various experimental models show synergistic anti-tumor effects and prolonged overall survival when naptumomab is combined with checkpoint inhibitors. Checkpoint inhibitors are a new group of cancer drugs, which function by unleashing the immune system to attack the tumor. Despite the successes of recent years with these immunotherapies, it remains a challenge for the immune system to recognize tumor cells, and there is a need to optimize the therapeutic effect of checkpoint inhibitors. Previous clinical trials have found naptumomab to be well-tolerated and demonstrated preliminary signals of efficacy.

Ongoing clinical development of naptumomab

An open-label, multicenter, dose-finding clinical phase Ib/II study with naptumomab in combination with durvalumab, a checkpoint inhibitor, is ongoing. The clinical trial enrolls patients with previously treated advanced or metastatic, 5T4-positive solid tumors and aims to establish the maximum tolerated dose in the phase Ib study before advancing to phase II cohort expansion studies. The trial was initiated in H2-2019 and is performed under an agreement with AstraZeneca. More information about the study design is available at clinicaltrials.gov (NCT03983954). The Study is enrolling to define the maximum tolerated dose (MTD) and the recommended phase II dose of the combination following pretreatment with the B-cell therapy, obinutuzimab. Preparations are ongoing for cohort expansions and phase

1. studies including a phase II study in the combination with docetaxel in non-small cell lung cancer (NCT04880863T).

EVENTS DURING THE SECOND QUARTER

• Active Biotech and NeoTX announce FDA clearance of IND for phase II clinical trial of naptumomab

4

INTERIM REPORT Q2 2021 | ACTIVE BIOTECH AB

EVENTS AFTER THE SECOND QUARTER

• Active Biotech provided status update on the progress in its clinical naptumomab project
• Active Biotech's partner NeoTX hosted KOL webinar on overcoming checkpoint inhibitor resistance- Naptumomab, a tumor targeting super antigen, designed to produce an efficient antibacterial immune response despite inefficient tumor immunity, show synergy with checkpoint inhibitors, chemotherapy as well as CAR-T-cell treatment in preclinical tumor models. This indicates a potential role of naptumomab to overcome treatment resistance to a broad range of cancer therapies. Initial results indicate that pretreatment with the B-cell therapy obinutuzumab lowers the levels of anti- drug antibodies (ADAs) to naptumomab. To view the recorded webinar please visit www.neotx.com

Tasquinimod

Tasquinimod is a once-daily, oral immunomodulatory compound that affects the tumor's ability to grow and spread.

Tasquinimod has been studied in both healthy subjects and cancer patients. Clinical effects and an overall good tolerability have been demonstrated in 1,500 patients, representing more than 650 patient-years of exposure to tasquinimod.

Today the development program for tasquinimod is directed towards hematological malignancies with a specific focus on treatment of multiple myeloma, a rare form of blood cancer with a high medical need. Tasquinimod's mode of action is novel and different to that of the four main classes of standard therapy used today in multiple myeloma. There is an urgent need of efficacious and safe combination regimens including drugs with novel mode of actions to mitigate drug resistance.

Preclinical data from experimental models of multiple myeloma demonstrating effect of tasquinimod as a monotherapy and in combination with standard multiple myeloma treatment. Data have been derived in collaboration with Wistar institute in Philadelphia, US and at Vrije Universiteit Brussel, Belgium. Patents in key markets have been granted, and applications have been submitted, providing potential protection for the use of tasquinimod in multiple myeloma, until 2041. Furthermore, the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for tasquinimod for the treatment of multiple myeloma, which provides for seven years of market exclusivity in the event of future registration.

Ongoing clinical development of tasquinimod

Based on the preclinical data and the previous clinical experience with tasquinimod, a clinical study was initiated, and the first patient was dosed in August 2020, clinicaltrials.gov (NCT04405167) .

The study recruits relapsed refractory patients after at least one prior anti-myeloma therapy and is conducted in two parts: the first part (A) assessing monotherapy effect of tasquinimod, and the second part (B) a combination of tasquinimod and an oral standard anti-myeloma regimen (IRd; ixazomib, lenalidomide, dexamethasone). Primary endpoint in both parts is safety and tolerability, and key secondary endpoint is preliminary efficacy by overall response rate. The study is carried out in an academic partnership with Abramson Cancer Center in Philadelphia, PA, US, with Dr. Dan Vogl as principal investigator.

The phase Ib/IIa study is ongoing according to plan, and Active Biotech currently expects the first safety readout in H2-2021. Following established safety, a maximum tolerated dose (MTD) expansion cohort will be started as well as the dose escalation of Part B, combination part of the study. The final readout of mono therapy tasquinimod is expected in H2-2022. Important corelative analysis of study bio-samples will be performed at the Wistar Institute in Philadelphia. These analyses aim at supporting further understanding of tasquinimod biological effects in the disease.

5