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Alpha Tau Issues Letter to Shareholders: Five Concurrent Trials in the U.S. with Multiple Significant Value-Driving Milestones Ahead

On January 29, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported the following letter to shareholders:

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Following an incredibly productive 2025, culminating in several significant announcements in recent weeks, I wish to share with you an updated comprehensive picture of Alpha Tau’s position and projected upcoming milestones, as we continue to push forward with our clinical, operational and pre-commercial development on a number of different fronts.

Extensive Ongoing Clinical Activity

The Company is currently conducting multiple significant clinical trials around the world, with five concurrently approved trials in the U.S.:

● Our ReSTART (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy) multi-center pivotal trial in patients with recurrent cutaneous squamous cell carcinoma (cSCC) , the second most common form of skin cancer: View Source

● Our multicenter study in immunocompromised patients with cSCC: View Source

● Our IMPACT (Intratumoral Pancreatic Alpha Combination Trial) multi-center pilot study in patients with newly-diagnosed pancreatic cancer in combination with chemotherapy: View Source

● Our feasibility study in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive malignant brain tumor: View Source

● Our pilot study in patients with locally recurrent prostate cancer: View Source

We are proud of our incredibly comprehensive clinical program, with Alpha DaRT being evaluated simultaneously across a number of indications. Our strategy of parallel exploration of multiple cancer types provides several opportunities for potential regulatory approval while seeking to demonstrate the platform’s broad applicability.

In addition, the Company has trials approved in France and Italy and is planning a large potential basket trial in the UK to evaluate our Alpha DaRT across numerous cancer types, alongside a number of ongoing feasibility studies in Israel. In particular, I would cite the ongoing trials in Israel treating patients with tumors of the prostate, lung and pancreas, as well as our TARGETS trial, which is open to patients with any type of malignant tumors of up to 7 cm in length, in lieu of ad hoc compassionate use treatments.

We also continue to maintain open and ongoing dialogue with the FDA, including in the context of regular quarterly meetings, as we continue to explore new potential applications and more comprehensive U.S. trials of the Alpha DaRT.

Continued Clinical Validation and Upcoming Milestones Across Expanded Indication Set

As you all know, the Company started its clinical evaluations by treating superficial tumors as a proof of concept, i.e., tumors of the skin or head and neck, and has acquired significant experience in the U.S., Europe, Japan and Israel. More recently, we have started receiving results from trials in internal organs, primarily pancreatic cancer, and continue to be encouraged by the potential of Alpha DaRT to deliver a potent but conformal dose of alpha radiation to a very a broad set of tumors with poor or no available alternatives.

Targeting Completion of Patient Recruitment in Pancreatic Cancer Study End of Q1 2026

In light of the encouraging data from the Company’s first-in-human studies in Canada and Israel in patients with pancreatic cancer, which was initially read out in interim form last year (View Source) and then recently reported from the Canadian study in more detail at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (View Source), we continue to conduct our IMPACT study with great clinician and patient interest, and are targeting the completion of patient accrual at the end of the first quarter of 2026 and initial results by the end of the year.

Expecting Initial GBM Results Around End of Q4 2026

Recently we reported the treatment of our first patient in GBM at Ohio State University (View Source). Per the protocol and in line with our conservative approach to carefully watching for any safety signals, we will limit our treatments to one patient per month for the first three patients, all at Ohio State University. To the extent that no safety concerns arise, we would anticipate the removal of enrollment restrictions as well as expansion to New York University as a second site in the trial, in which case we would target the completion of patient accrual for ten patients later in the year, with initial results targeted around year end 2026.

Potential Regulatory Approval in Japan

In addition, the Company is anticipating a response shortly from Japan’s Ministry of Health, Labour and Welfare regarding our application for approval of Alpha DaRT in the treatment of recurrent head & neck cancer. We are preparing for potential post-marketing surveillance requirements in Japan should the response be positive. A positive regulatory decision in Japan would mark Alpha DaRT’s first commercial approval outside of Israel, further validating our technology and regulatory strategy.

Alpha DaRT as a Combination Therapy with Checkpoint Inhibitors

The Company also anticipates exploring an additional clinical trial with the FDA in 2026, examining the combination of Alpha DaRT with checkpoint inhibitor therapeutics for patients with locally advanced or metastatic head & neck squamous cell carcinoma, on the back of fantastic interim data we released last year from a similar study conducted in Jerusalem, and we are hoping that this will become our sixth active trial in parallel in the U.S. We reported interim results in January 2025 from the clinical study conducted in Israel in this use case (View Source). This trial is incredibly important from a strategic perspective, as it reaches a very special population and also looks to demonstrate broader systemic relevance of Alpha DaRT treatment. While the majority of our clinical trials focus on the first two of our strategic pillars of focus (localized & unresectable tumors, and tumors of high unmet need), this is our first foray into exploring our third strategic pillar, the potential use of Alpha DaRT to provide systemic benefits to patients with metastatic tumors.

In parallel, the Company is also engaged in significant pre-clinical work in partnership with leading academic institutions, including Mayo Clinic, McGill University, Emory University and MD Anderson Cancer Center, exploring different combinations with immunotherapy, which we see as an important future direction for use of Alpha DaRT.

As such, we expect an incredibly busy year in 2026 from a clinical perspective, including significant data readouts from our ReSTART pivotal trial and trials in cancers of internal organs.

Commercial and Operational Readiness

We see tremendous importance to generating additional data on the use of Alpha DaRT in tumors of internal organs such as the pancreas and the brain, in order to support future decisions on launch sequencing in different indications. As we have reported in the past, we expect to complete recruitment of the ReSTART study in this quarter, and have started to submit modules of our Modular PMA to the FDA (View Source), and expect to complete the submission toward year end. Therefore, launch sequencing continues to present interesting strategic questions in light of the broad applicability of Alpha DaRT.

As we have reported in the past, the Company is currently manufacturing Alpha DaRT treatments in Jerusalem and Thorium-228 generators in Lawrence, MA, at a scale that can supply our clinical trials, validations and pre-clinical work. However, we have also reported the receipt of a radioactive license for the first phase of our Hudson, NH facility, which is being built in phases (View Source), and are currently working on equipping that first phase with the equipment needed for Alpha DaRT manufacturing.

At the same time, we continue to build out and adjust our organizational structure to prepare for future commercialization, including investments in scaling up manufacturing, in devices and accessories for mass production such as injection molds, in robotics and automation, and in development of new manufacturing methods that will increase our output and efficiency.

Well Financed and Positioned for Execution

Our cash burn rate has remained fairly stable to date other than some minor peaks associated with investment into our manufacturing capacity, and we remain confident that we can continue to execute on our current plans.

We continue to vigorously seek protection of our intellectual property, which we see as an important fruit of the extensive labors of our R&D teams, and key to protecting our future commercial potential. In 2025 alone, we filed over 60 new patent applications of different types around the world and were granted or allowed nearly 50 patents around the world.

In light of increasing recognition of the relevance of Alpha DaRT to the broader radiotherapy and oncology therapeutics landscapes, we see increased strategic dialogue with potential partners, across a number of potential areas for collaboration. We continue to entertain a number of interesting conversations, while not losing sight of our core focus on executing on our strategy.

(Press release, Alpha Tau Medical, JAN 29, 2026, View Source [SID1234662346])

AB Science receives notice of allowance for US patent covering masitinib in the treatment of metastatic castrate resistant prostate cancer

On January 29, 2026 AB Science SA (Euronext – FR0010557264 – AB) reported that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance (NOA) for a patent relating to methods of treating metastatic castrate resistant prostate cancer (mCRPC) with its lead compound masitinib (US 18/040884).

Delivery of masitinib patent in mCRPC

Once granted, this new US secondary medical use patent will provide intellectual property (IP) protection for masitinib in mCRPC until May 2042. A NOA signifies that the USPTO intends to grant the patent application after completing certain formal procedural steps. The US NOA is issued after an examiner confirms that the patent application meets all patentability requirements.

This new US patent adds to the IP coverage already granted in Europe (EP4175639) [1].

Counterpart patent applications have also been filed in other major international markets.

Masitinib positioning in metastatic prostate cancer after failure to hormone therapy

In metastatic prostate cancer, patients take hormone therapies (i.e., androgen-deprivation therapy) in first line and second line. Then when metastatic cancer advances patients have to be treated by chemotherapy. There is only one chemotherapy registered, docetaxel, and no drug in combination with docetaxel or replacement of docetaxel has improved PFS or OS and has been registered for the last 20 years.

Masitinib is positioned in combination with docetaxel as a treatment of mCRPC patients who are eligible to chemotherapy. That is to say, it is administered directly following the metastatic hormone-sensitive prostate cancer (mHSPC) treatment space.

Masitinib is one of the rare drugs to have generated positive data on progression free survival (PFS) in combination with docetaxel in this population.

Masitinib positioning in mCRPC with low metastatic involvement measured by a biomarker

More specifically, this patent provides protection for masitinib and related compounds for the treatment of mCRPC in a patient subpopulation with low metastatic involvement (as measured by baseline alkaline phosphatase levels).

This patient population is fully consistent with the results of the masitinib study AB12003 [2] and the ongoing clinical development program of masitinib in mCRPC.

As a reminder, the key results from study AB12003 include:

Masitinib (6.0 mg/kg/day) plus docetaxel conferred a significant progression-free survival (PFS) benefit in mCRPC patients with baseline alkaline phosphatase levels (ALP) less than or equal to 250 IU/L; hazard ratio of 0.79 [0.64,0.97] (p=0.0087), corresponding to a 21% reduction in risk of progression relative to control.
Assessment of PFS rates was convergent with this primary outcome, with 12-, 18-, and 24-month PFS rates showing significant improvement in favor of masitinib plus docetaxel relative to the control: 1.6-fold (p=0.0035), 1.9-fold (p=0.0001), and 1.9-fold (p=0.0028), respectively.
A progressively greater masitinib treatment effect was observed for lower baseline ALP levels (i.e., less advanced metastatic disease), with a significant 47% reduced risk of progression in patients with ALP less than or equal to 100 IU/L (hazard ratio=0.53, p=0.002).
The safety profile of masitinib plus docetaxel was acceptable and consistent with the known masitinib profile, with no new safety signals observed.
Unmet medical need in mCRPC

Although localized disease is associated with high survival rates, metastatic prostate cancer still represents an unmet medical need with a 5-years survival rate of approximately 32% [3]. Practically all patients with metastatic disease become resistant to androgen-deprivation therapy.

With 1.5 million new cases and 397,000 deaths worldwide, prostate cancer is the world’s second most frequent cancer and the fifth leading cause of cancer death among men [4]. It is estimated that there are at least 3.5 million men living with prostate cancer in the United States [5] and 2.5 million in Europe [6]. Approximately 2% of all prostate cancer cases are mCRPC [7], and practically all patients with metastatic disease will become resistant to androgen-deprivation therapy. As such, the population with mCRPC eligible to chemotherapy is around 50,000 in the EU and 70,000 in the USA.

(Press release, AB Science, JAN 29, 2026, https://www.ab-science.com/ab-science-receives-notice-of-allowance-for-us-patent-covering-masitinib-in-the-treatment-of-metastatic-castrate-resistant-prostate-cancer/ [SID1234662345])

Four additional sites open for recruitment in Oncoinvent’s Phase 2 trial

On January 29, 2026 Oncoinvent, a clinical stage, radiopharmaceutical company developing innovative treatments for solid cancers, reported that the first patient has been enrolled at one of the newly activated sites in its Phase 2 study of Radspherin in patients with peritoneal carcinomatosis from ovarian cancer.

The randomized part of the study has been actively recruiting patients at six sites since March 2025. Four additional sites have now been opened, and the first patient has been enrolled at one of these newly activated sites.

"The process of opening new clinical sites involves extensive regulatory reviews, contracting, and site-readiness work. We are therefore pleased to see both the successful activation of additional sites and the enrollment of the first patient at a newly onboarded site," said Kari Myren, Chief Medical Officer at Oncoinvent.

The Phase 2 trial (Clinicaltrial.gov: NCT06504147) is a randomized controlled trial assessing the efficacy and safety of Radspherin in patients with peritoneal metastases from ovarian cancer. The primary objective is to compare progression-free survival (PFS) between patients who receive Radspherin after complete surgical resection following pre-operative chemotherapy, and patients receiving pre-operative chemotherapy and surgery alone.

The study will recruit patients at a total of 11 sites across Norway (1), Spain (5), Belgium (1), the United Kingdom (2), the United States (1), and Italy (1). Positive Phase 1/2a data from the safety interim analysis demonstrated that Radspherin was well tolerated with no dose-limiting toxicity observed at the recommended dose of 7MBq.

(Press release, Oncoinvent, JAN 29, 2026, https://www.oncoinvent.com/press-release/four-additional-sites-open-for-recruitment-in-oncoinvents-phase-2-trial/ [SID1234662334])

Immutep Quarterly Activities Report Q2 FY26

On January 29, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported an update on its activities for the quarter ended 31 December 2025 (Q2 FY26).

EFTI DEVELOPMENT PROGRAM IN ONCOLOGY

IMMUTEP AND DR. REDDY’S STRATEGIC COLLABORATION

Most significantly, in December, Immutep and Dr. Reddy’s announced that their respective wholly-owned subsidiaries, Immutep SAS and Dr. Reddy’s Laboratories SA, entered into a strategic collaboration and exclusive licensing agreement for the development and commercialisation of eftilagimod alfa (efti) in all countries outside North America, Europe, Japan, and Greater China.

Efti is Immutep’s first-in-class novel immunotherapy that directly activates the immune system to fight cancer, which is under evaluation in a Phase III trial, TACTI-004 (KEYNOTE-F91).

As per the agreement, and after the quarter’s end, Immutep has received from Dr. Reddy’s the upfront payment of USD 20 million (~AUD 30.2 million). It is also eligible to receive potential regulatory development and commercial milestone payments of up to USD 349.5 million (~AUD 528.4 million), plus royalties on commercial sales in these markets.

Immutep holds the global manufacturing rights to the product across all markets and will supply the product to Dr. Reddy’s in the licensed markets. Immutep retains all rights to the product in the key pharmaceutical markets, including North America, Europe, and Japan.

LUNG CANCER

TACTI-004 (KEYNOTE-F91) – Ongoing Phase III Trial in 1L NSCLC

In December, Immutep reported strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC), one of the largest indications in oncology.

The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC by expanding the number of patients who respond to anti-PD-1 therapy, across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients’ survival.

As of mid-December, the registrational TACTI-004 trial had enrolled 289 patients (over 38% of the trial’s targeted enrolment of 756 patients), and enrolment continues at a robust pace. Additionally, the number of activated clinical sites exceeded 120 and 27 countries had received full regulatory approvals.

As announced in October 2025, TACTI-004 had enrolled the necessary number of patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Immutep anticipates reaching 50% of the patient enrolment target for TACTI-004 soon.

Additionally, with the completion of Project Optimus as discussed below, TACTI-004 has started to open sites in the United States.

INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC

In October, Immutep announced promising data from the investigator-initiated INSIGHT-003 trial, which is evaluating the same immunotherapy/chemotherapy combination used in TACTI-004 (KEYNOTE-F91), was detailed in a poster presented by Dr. med. Akin Atmaca, Head of the Thoracic Oncology, Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany at the ESMO (Free ESMO Whitepaper) Congress 2025.

In this multi-centre study, the novel combination of efti with KEYTRUDA and chemotherapy (carboplatin/pemetrexed) has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels.

Notably, the ORR and DCR reported in INSIGHT-003 outperforms historical controls irrespective of PD-L1 levels (e.g., TPS <1%, TPS 1-49%, and TPS >50%). This is particularly important for patients with low and no PD-L1 (TPS <50%), who represent over two-thirds of the 1L NSCLC patient population and for whom PD-(L)1 inhibitors typically perform suboptimally. In patients with TPS <50% (N=47), the combination with efti has achieved a strong and improved 61.7% ORR compared to historical control of 40.8%.1,2

Further to the strong efficacy data from INSIGHT-003, the combination with efti continues to have a favourable safety profile.

SOFT TISSUE SARCOMA

EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma

In October, Immutep announced that positive data from the EFTISARC-NEO Phase II investigator-initiated trial evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) was shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland at the ESMO (Free ESMO Whitepaper) Congress 2025 in Berlin, Germany.

The EFTISARC-NEO trial met the primary endpoint and significantly exceeded the study’s prespecified 35% tumour hyalinization/fibrosis with a median 51.5% tumour hyalinization/fibrosis (p<0.001) in the evaluable patient population (N=38).3 This may hold significance in terms of future outcomes as tumour hyalinization/fibrosis serves as an early surrogate endpoint correlated with improved survival in STS patients.4 Disease-free survival and overall survival data are immature at this stage and will be presented in the future.

In November, early translational data from the EFTISARC-NEO trial were detailed in an oral presentation by Paweł Sobczuk, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting held in Boca Raton, Florida. Results from the initial twenty patients who underwent surgery in the trial show a strong immune system activation in line with efti’s mode of action, with statistically significant increases in the expression of key cytokines and chemokines in peripheral blood — specifically CXCL9, CXCL10, IL-23, and IFN-γ.

The increase on treatment of immune response biomarkers like IFN-γ correlated with pathologic responses in this study, meaning patients with a biomarker increase during treatment also had a higher probability of a good clinical response at surgery.

Additionally, during the quarter, the EFTISARC NEO trial was awarded second place in the distinguished Golden Scalpel Award competition in Poland. This competition recognises the most innovative solutions in Polish medicine and is presented by independent experts to initiatives that set new standards in advancing healthcare. EFTISARC-NEO was the only oncology project to receive this accolade, underscoring its leadership and breakthrough potential in cancer treatment.

BREAST CANCER

AIPAC-003 – Phase II/III Trial in Metastatic Breast Cancer

Immutep continues to execute the AIPAC-003 trial, which has enrolled 71 metastatic hormone receptor positive (HR+), HER2-negative/low patients resistant to endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or triple-negative breast cancer patients.

Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in late 2024. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30 mg or 90 mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative and prior regulatory interaction with FDA.

In October, Immutep announced that positive feedback had been received from the US Food and Drug Administration ("FDA") regarding the successful completion of Project Optimus requirements and agreement on 30 mg as the optimal biological dose for efti. The agreement with the FDA on efti’s optimal biological dosing carries strategic importance in the ongoing and future clinical development of efti, including the global TACTI-004 (KEYNOTE-F91) Phase III trial.

In December, Immutep announced that new data from the AIPAC-003 trial was presented by Dr. Nuhad Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas.

The data presented shows that both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64).

New Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer

Immutep continues to progress with a new investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer patients. The trial aims to assess pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC).

The study will treat up to 50 evaluable patients in a two-stage design and will be primarily funded by grants and The GW University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget.

UROTHELIAL CANCER

INSIGHT-005

The investigator-initiated INSIGHT-005 Phase I study, conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) to evaluate the safety and efficacy of efti in combination with avelumab in up to 30 patients with metastatic urothelial cancer, was discontinued by IKF after the end of the quarter. This decision was made, as significant changes in the treatment landscape created challenges with patient recruitment. Only 3 patients were recruited in total.

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE

IMP761 – Phase I Trial

In December, Immutep announced a positive update from the placebo-controlled, double-blind first-in-human Phase I study in healthy participants evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases.

The single-ascending dose escalation portion of the trial successfully completed the 2.5 and 7 mg / kg dosing levels of IMP761 with continued positive safety and efficacy data. IMP761 was tolerated well with no treatment-related adverse reactions beyond mild intensity. Additionally, evidence of dose dependent immunosuppressive effects with IMP761 was observed with significant, long-lasting inhibition of the three T-cell-mediated intradermal reactions to a strong foreign antigen on day 2, 9 and 23.

Given the encouraging efficacy and safety to date, the trial will continue as planned and additional updates are anticipated in the first half of CY2026 including a planned presentation of data at a major medical conference.

INTELLECTUAL PROPERTY

During the quarter, Immutep was granted four patents.

The New Zealand Patent Office granted a new patent protecting Immutep’s intellectual property for a binding assay for determining MHC Class II binding activity of LAG-3 protein. The assay is used in the characterisation of efti in GMP-grade manufacturing.

Three new patents directed to IMP761 were also granted. Two were granted in Brazil and one in Japan.

CORPORATE & FINANCIAL SUMMARY

Annual General Meeting
Immutep successfully held its Annual General Meeting (AGM) during the quarter, with all resolutions put forward to shareholders strongly approved. The Company appreciates the continued support and engagement of its shareholders as it advances its strategic and operational objectives.

Cash Flow Summary

During the quarter, Immutep continued to exercise prudent cash management as it advanced its clinical trial programs for efti and for IMP761.

The Company is well funded with a strong cash and cash equivalent, and term deposit balance as at 31 December 2025 of approximately A$99.1 million, which is in line with budget as at the beginning of FY2026, while progressing our clinical programs within announced timeframes. The total balance consists of 1) a cash and cash equivalent balance of A$72.7 million and 2) bank term deposits totaling A$26.4 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months. This amount is topped up by the upfront payment (~A$30.2 million) from Dr. Reddy’s received in January 2026, leading to a pro-forma balance of A$129.3 million at the time of preparing this report.

In Q2 FY26, cash receipts from customers were A$4k. The net cash used in G&A activities in the quarter was A$1.3 million, compared to A$578k in Q1 FY26. During the quarter, Immutep received EUR2.59 million (~ A$4.6 million) R&D tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR) to support the ongoing and planned global clinical development of efti and IMP761.

The cash used in R&D activities during the quarter was A$9.9 million, compared to A$15.8 million in Q1 FY26. The higher figure in the prior quarter was primarily due to the large prepaid clinical trial expenses and higher milestone‑based manufacturing payments made in Q1 FY26.

Payment for staff costs was A$2.6 million in the quarter, compared to A$3.4 million in Q1 FY26. Total net cash outflows used in operating activities in the quarter were A$9.4 million compared to A$19.0 million in Q1 FY26.

Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$474k.

Total cash outflow used in investing activities for the quarter was A$144k, which is mainly for the acquisition of office and lab equipment.

Furthermore, during the quarter, a long-term vendor* agreed to defer payment of ~A$30 million which would be payable by Immutep for future services related to Biologics License Application (BLA) readiness by up to 30 months. This provides strong external validation of Immutep’s development strategy and long-term value creation potential.

The current funds available to the Company at the time of this report provide an expected cash reach well into Q2 CY2027, not including receipt of any future potential milestone payments to be received.

(Press release, Immutep, JAN 29, 2026, View Source [SID1234662333])

Quarterly Shareholder Report December 2025

On January 29, 2026 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported a summary of its activities for the quarter ended 31 December 2025:

Lead asset amsulostat continues to build momentum

Amsulostat clinical and preclinical data presented at American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando

Second myelodysplastic syndrome (MDS) study initiated with launch of amsulostat Phase 2 Australian MESSAGE trial in transfusion-dependent low and intermediate risk patients

Positive European Medicines Agency opinion received for Orphan Drug Designation of amsulostat in myelofibrosis

Pancreatic cancer Phase 1/2 clinical trial of amsulostat in collaboration with the Garvan, funded by MRFF, announced post quarter end

Pipeline assets progress

SNT-4728 Phase 2 iRBD trial fully recruited with data expected in Q2 2026, triggering payment of $1.8 million expected in Q1 2026

Progression of topical anti-fibrotic SNT-9465 into hypertrophic scar study following successful completion of Phase 1a study

Proforma cash balance at 31 December of $12.3 million.

Syntara CEO Gary Phillips said: "2026 is shaping up to be a pivotal year for Syntara, with five separate data read-outs expected across the Company’s clinical portfolio, each capable of materially advancing both value and strategic optionality.

In haematology, the initiation of the Phase 2 MESSAGE trial in transfusiondependent MDS represents a further expansion for amsulostat (SNT-5505), backed by strong external validation through the Australasian Leukaemia & Lymphoma Group (ALLG) and non-dilutive support from the Medical Research Future Fund. I’m excited to see if the compelling pre-clinical data for amsulostat in MDS translates into the clinic. By mid-2026 we should see preliminary data from this study and the MDS trial in a high risk population being run in Germany that extends the drug’s utility more widely across myeloproliferative neoplasms.

Across the broader pipeline, our topical anti fibrotic, SNT-9465, has progressed into a three-month study treating patients with sternotomy scars following a successful first-in-human study, with results expected in 2026 alongside the ongoing SATELLITE keloid pilot study. We received a lot of positive feedback about the KOL skin scarring webinar we ran with Prof Ardeshir Bayat in November. It was inspiring to hear from a renowned leader in the field of scarring really unpack what is going on in an abnormal scarring process. His explanation about how our pan-LOX inhibitor can potentially "unlock the scar" and lead to permanent improvements in appearance and function is all the motivation we need to accelerate the development of this element of our pipeline.

Meanwhile our neuroinflammatory targeting drug, SNT-4728, has now completed recruitment in its Phase 2 iRBD trial with top-line results expected in Q2 2026. This result is keenly anticipated by our partners in the field of Parkinson’s Disease research and adds to the compelling cadence of catalysts that positions 2026 as a defining year for the Company."

(Press release, Syntara, JAN 29, 2026, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/dc90a199-0b91-520d-956a-91abeb3a25cc/2A1650256_SNT.pdf [SID1234662332])