On August 4, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported financial results for the three and six months ended June 30, 2026 and provided an update on its corporate progress.

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"In the first half of 2026, we made important progress in turning our mission into reality. We significantly advanced our late-stage oncology pipeline, with six pivotal trials initiated; we pioneered the generation of first-in-class global Phase 2 data for an investigational PD-L1xVEGF bispecific antibody in first-line non-small cell lung cancer across PD-L1 expression levels and histologies; and we demonstrated at medical congresses that our novel-novel combination therapy strategy is gaining momentum," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "We look forward to welcoming BioNTech’s next CEO. Guido Oelkers will take office by February 1, 2027, at the latest, and, together with the Management Board and teams across the company, is expected to continue to write the BioNTech success story."

Financial Review for Second Quarter and First Half of 2026

in millions €,
except per share data Second Quarter 2026 Second Quarter 2025
IFRS Results Adjusted Results2 IFRS Results Adjusted Results2
Revenues 105.6 105.6 260.8 260.8
Net loss (820.8) (562.3) (386.6) (348.8)
Diluted loss per share (3.24) (2.22) (1.60) (1.45)

in millions €,
except per share data Year-to-date 2026 Year-to-date 2025
IFRS Results Adjusted Results2 IFRS Results Adjusted Results2
Revenues 223.7 223.7 443.6 443.6
Net loss (1,352.7) (1,056.9) (802.4) (779.6)
Diluted loss per share (5.34) (4.17) (3.33) (3.23)
Below figures compare the second quarter of 2026 and the year-to-date period ended June 30, 2026, to the corresponding prior year periods, except as noted.

Revenues were €105.6 million for the second quarter of 2026, compared to €260.8 million. Year-to-date revenues were €223.7 million, compared to €443.6 million. The decreases in both quarterly and year-to-date revenues compared to the prior year were primarily driven by lower demand from BioNTech’s COVID-19 vaccines.

Research and development ("R&D") expenses were €551.0 million for the second quarter of 2026, compared to €509.1 million. Year-to-date R&D expenses were €1,108.0 million, compared to €1,034.7 million. R&D expenses were mainly driven by higher expenses for the development of immuno-oncology ("IO") and antibody-drug conjugate ("ADC") programs, in particular pumitamig and gotistobart, impairment losses of intangible assets, and the inclusion of operations from CureVac, which was acquired in late 2025. The quarterly and year-to-date increases were partially offset by lower costs from non-focus programs and positive effects from cost shares with BioNTech’s collaboration partners.

Adjusted R&D expenses were €477.1 million for the second quarter of 2026, compared to €509.1 million. Year-to-date adjusted R&D expenses were €1,004.2 million, compared to €1,034.7 million. Adjusted R&D expenses for both the second quarter and year-to-date period in 2026 exclude impairment losses of intangible assets.

Sales, general and administrative ("SG&A") expenses were €197.8 million for the second quarter of 2026, compared to €137.4 million. Year-to-date SG&A expenses were €348.6 million, compared to €258.0 million. The increases in both quarterly and year-to-date were mainly driven by the ongoing pre‑launch activities and commercial build-up, the inclusion of operations from CureVac, and expenses associated with BioNTech’s global initiative on scaling processes and ERP infrastructure to strengthen operational execution. This was partly offset by cost reductions resulting from the execution of initiatives related to BioNTech’s pipeline prioritization and increased cost discipline.

Other operating result was negative €207.9 million for the second quarter of 2026, compared to negative €39.0 million. Year-to-date other operating result was negative €224.3 million, compared to negative €25.9 million. Both quarterly and year-to-date decreases were primarily driven by higher expenses in connection with BioNTech’s pipeline prioritization.

Adjusted other operating result was negative €23.3 million for the second quarter of 2026, compared to negative €1.2 million. Year-to-date adjusted other operating result was negative €32.3 million, compared to negative €3.1 million. Adjusted other operating results for both the second quarter and year-to-date periods in 2026 and 2025 exclude employee-related costs and impairment losses, both related to BioNTech’s pipeline prioritization.

Net loss was €820.8 million for the second quarter of 2026, compared to a net loss of €386.6 million. Year-to-date net loss was €1,352.7 million, compared to a net loss of €802.4 million.

Adjusted net loss was €562.3 million for the second quarter of 2026, compared to an adjusted net loss of €348.8 million. Year-to-date adjusted net loss was €1,056.9 million, compared to an adjusted net loss of €779.6 million.

Diluted loss per share was €3.24 for the second quarter of 2026, compared to a diluted loss per share of €1.60. Year-to-date diluted loss per share was €5.34, compared to a diluted loss per share of €3.33.

Adjusted diluted loss per share was €2.22 for the second quarter of 2026, compared to an adjusted diluted loss per share of €1.45. Year-to-date adjusted diluted loss per share was €4.17, compared to adjusted diluted loss per share of €3.23.

Cash, cash equivalents and security investments as of June 30, 2026 were €16,634.2 million, comprising €9,741.0 million in cash and cash equivalents, €5,035.1 million in current security investments disclosed as financial assets and €1,858.1 million in non-current security investments disclosed as financial assets.

Shares outstanding as of June 30, 2026 were 251,204,366, excluding 7,823,121 shares held in treasury.

In May 2026, BioNTech entered into a share repurchase program, pursuant to which the Company may purchase American Depositary Shares ("ADSs"), each representing one ordinary share of the Company, in the amount of up to $1.0 billion until and including May 6, 2027. During the second quarter of 2026, 1,693,056 ADSs were repurchased at an average price of $89.50 (€77.85), for total consideration of $151.6 million (€131.8 million).

"We are revising our full-year 2026 financial guidance in light of recently emerged external developments," said Ramón Zapata, Chief Financial Officer at BioNTech. "Our capital allocation strategy is delivering results: our financial position is strong, our share repurchase program is well underway, and we continue to make meaningful progress across our pipeline. Moving forward, we continue to execute on our strategy to turn BioNTech into a multi-product biopharmaceutical company by 2030."

Revised 2026 Financial Year Guidance5:

2026 FY Guidance (March 2026) 2026 FY Guidance (August 2026)
Revenues €2,000 – €2,300 million €1,600 – €1,900 million
BioNTech is revising its full-year 2026 financial guidance revenue range due to:

COVID-19 vaccine market
Softer than anticipated global COVID-19 vaccine demand
In Germany existing vaccine inventory will be used in the 2026 vaccination season
The timing of milestone-related revenues resulting from an out-licensed R&D program, which are no longer expected in 2026.
BioNTech continues to expect the majority of 2026 revenues to be realized in the second half of the year, specifically in the third quarter, when it also expects to recognize the €613 million Bristol Myers Squibb Company ("BMS") collaboration revenue.

Planned 2026 Financial Year Adjusted Expenses5:

2026 FY Guidance (March 2026) 2026 FY Guidance (August 2026)
Adjusted R&D expenses €2,200 – €2,500 million €2,000 – €2,300 million
Adjusted SG&A expenses3 €700 – €800 million €700 – €800 million
BioNTech now expects adjusted R&D expenses in the range of €2.0 billion to €2.3 billion. Adjusted SG&A expenses remain unchanged in the range of €700 million to €800 million.

This reflects BioNTech’s focus on optimizing its R&D resources and continued cost discipline as it prioritizes the development of its late-stage clinical pipeline. The Company expects these cost savings based on prioritization and optimization to continue into future years.

BioNTech’s strong balance sheet and continued cost discipline support the Company’s ability to invest strategically.

The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on Form 6-K for the period ended June 30, 2026, filed today with the United States Securities and Exchange Commission ("SEC") and available at www.sec.gov.

Corporate and Commercial Update for the Second Quarter 2026 and Post Period Events

On August 3, 2026, BioNTech announced that the Supervisory Board has appointed Guido Oelkers, Ph.D., to the Management Board as Chief Executive Officer ("CEO"), who will take office by February 1, 2027, at the latest, succeeding Prof. Ugur Sahin, M.D. Guido Oelkers is a seasoned CEO and strategic leader with over 30 years of experience in the biotechnology and pharmaceutical industries. He has a strong track record of transforming and scaling global organizations, driving sustainable growth through disciplined execution, focused capital allocation, and operational excellence. Throughout his career, Guido Oelkers has successfully built, prioritized and strengthened complex and innovative product portfolios across multiple areas, including oncology and immunology, while driving global business operations in key markets, notably in the United States. He will join BioNTech from the global Nasdaq Stockholm-listed biopharmaceutical company Swedish Orphan Biovitrum AB ("Sobi"), where he has served as CEO since 2017.
In May 2026, the Company held its Annual General Meeting ("AGM"). Shareholders approved expanding the Supervisory Board from six to eight members and adding additional expertise: Prof. Iris Löw-Friedrich, M.D., Ph.D., and Susanne Schaffert, Ph.D., were elected as new members of the Supervisory Board.
Variant-adapted COVID-19 Vaccine

BioNTech and Pfizer Inc. ("Pfizer") have submitted regulatory applications to the European Medicines Agency ("EMA") and to the United States Food and Drug Administration ("FDA") for approval of their XFG variant-adapted monovalent COVID-19 vaccine for the 2026-2027 vaccination season.
In July 2026, BioNTech and Pfizer’s XFG variant-adapted monovalent COVID-19 vaccine was approved by the European Commission following recommendation for marketing authorization by the EMA’s Committee for Medicinal Products for Human Use ("CHMP").
Select Oncology Pipeline Updates

Next-Generation Immunomodulators and Combinations

Pumitamig (BNT327/BMS986545) is an investigational bispecific immunomodulator combining PD-L16 checkpoint inhibition with VEGF-A neutralization that is being developed in collaboration with BMS.

Pumitamig is currently being evaluated in seven pivotal trials across the ROSETTA clinical development program, with five new global clinical trials initiated in the first half of 2026 spanning triple-negative breast cancer, colorectal cancer, gastric cancer, and non-small cell lung cancer, including two NSCLC clinical trials in patients with unresectable stage III disease and advanced PD-L1 ≥ 50% disease, respectively.
A global Phase 2/3 clinical trial (ROSETTA Lung-02; NCT06712316) is ongoing to evaluate pumitamig in combination with chemotherapy compared to pembrolizumab and chemotherapy in patients with first-line NSCLC. The Phase 3 part of the trial is currently recruiting. In May 2026, data from the Phase 2 part of the trial was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting 2026. The data showed encouraging anti-tumor activity, with high response rates observed in both non-squamous and squamous NSCLC and across PD-L1 expression levels.
Pumitamig is also being evaluated in additional solid tumor indications, including first-line hepatocellular carcinoma ("HCC"), second-line glioblastoma ("GBM"), first-line pancreatic ductal adenocarcinoma ("PDAC") and first-line renal cell carcinoma ("RCC") in various Phase 1/2 and Phase 2 trials, both as monotherapy and in combination with standard of care.
BioNTech has several signal-seeking clinical trials ongoing evaluating pumitamig in novel/novel combinations with the Company’s proprietary assets. These trials will inform the dose selection for pumitamig and explore anti-tumor activity in multiple tumors for later-stage development. Multiple data readouts from these combinations are expected in 2026.
Gotistobart (BNT316/ONC-392) is a tumor microenvironment-selective regulatory T cell depletion candidate that targets CTLA-4 and is being developed in collaboration with OncoC4, Inc. ("OncoC4").

A global Phase 3 clinical trial (PRESERVE-003; NCT05671510) is ongoing to evaluate the efficacy and safety of gotistobart as monotherapy in patients with metastatic squamous NSCLC that progressed on previous platinum-based chemotherapy and PD-(L)1-inhibitor treatment.
In March 2026, updated data from the non-pivotal dose-confirmation stage, the first of two stages of the global Phase 3 clinical trial, were presented at the European Lung Cancer Congress ("ELCC"). Gotistobart demonstrated a clinically meaningful overall survival benefit (hazard ratio: 0.46) compared to standard of care chemotherapy and a manageable safety profile in patients with squamous NSCLC whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy.
Updated data from the Stage 1 of this trial are expected to be presented at the International Association for the Study of Lung Cancer ("IASLC") 2026 World Conference on Lung Cancer ("WCLC").
Based on current event accrual projections, the first interim analysis from Stage 2 of the two-stage Phase 3 clinical trial is expected in 2026.
A Phase 2 clinical trial (PRESERVE-004; NCT05446298) is being conducted to evaluate gotistobart in combination with pembrolizumab in patients with platinum-resistant ovarian cancer ("PROC").
In May 2026, data from the trial were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting 2026. Gotistobart in combination with pembrolizumab demonstrated encouraging and durable antitumor activity in heavily pretreated patients with PROC.
Antibody-Drug Conjugates

Trastuzumab pamirtecan (BNT323/DB-1303) is an ADC candidate targeting HER2 that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio").

A Phase 1/2 clinical trial (NCT05150691) is being conducted to evaluate trastuzumab pamirtecan in patients with advanced HER2-expressing tumors. A potentially registrational cohort with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with recurrent endometrial cancer ("EC") is fully recruited.
In June 2026, additional data were presented from the Phase 2 portion of the trial at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress 2026 in Copenhagen, Denmark. Trastuzumab pamirtecan showed encouraging and durable anti-tumor activity and meaningful survival in patients with advanced HER2-expressing endometrial cancer. The safety profile was manageable and consistent with the known class effects of anti-HER2 ADCs.
A Phase 3 clinical trial (FERN-EC-01, NCT06340568) is being conducted to evaluate trastuzumab pamirtecan compared to investigator’s choice of chemotherapy in patients with advanced and HER2-expressing recurrent EC.
A Phase 3 clinical trial (DYNASTY-Breast02, NCT06018337) to evaluate trastuzumab pamirtecan in patients with HR-positive, HER2-low metastatic breast cancer is ongoing. Based on current event accrual projections, the primary analysis is expected in the fourth quarter 2026.
While BioNTech and DualityBio plan to file a biologics license application ("BLA") in 2026, the companies will determine the optimal regulatory path for trastuzumab pamirtecan based on the totality of clinical data in endometrial cancer and breast cancer. This approach is in line with the companies’ value-optimization strategy for the asset in an evolving treatment landscape and focuses on prioritizing opportunities where they can deliver significant benefit for patients.
Elfetabart drozuntecan (BNT324/DB-1311) is an ADC candidate targeting B7-H3 that is being developed in collaboration with DualityBio. More than one thousand patients have now been treated with elfetabart drozuntecan in clinical trials across more than ten tumor types, including 400 patients treated with elfetabart drozuntecan in combination with pumitamig.

In May 2026, a Phase 3 clinical trial (NCT07365995) to evaluate elfetabart drozuntecan compared to docetaxel in patients with metastatic castration-resistant prostate cancer ("mCRPC") was initiated.
Upcoming Investor and Analyst Events

BioNTech Third Quarter 2026 Financial Results and Corporate Update: November 3, 2026
Conference Call and Webcast Information
BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, August 4, 2026, at 8:00 a.m. EDT (2:00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter of 2026.

To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN number will be provided.

The slide presentation and audio of the webcast will be available via this link.

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor section of the Company’s website at www.BioNTech.com. A replay of the webcast will be made available shortly after the closing of the call and archived on the Company’s website for 30 days following the call.

(Press release, BioNTech, AUG 4, 2026, View Source [SID1234669684])

On August 4, 2026 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, reported its financial results for the second quarter of 2026 and provided an update on recent business progress.

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "The past several weeks mark a defining chapter for Nuvectis with the in-licensing of our new lead drug candidate, ciprocopan (NXP100), a Complement Factor B Inhibitor for once-daily oral administration, and the expansion of our oncology pipeline with the in-licensing of NXP200, an oral, brain-penetrant, paradox-breaker BRAF inhibitor. Approximately two weeks ago, ciprocopan received its first marketing approval in China for the treatment of patients with paroxysmal nocturnal hemoglobinuria ("PNH") not previously treated with complement inhibitors. This approval marks the first global approval of a once-daily, oral Complement Factor B inhibitor, bringing about a meaningful new treatment option for patients with PNH in China, and also highlights ciprocopan’s compelling clinical profile and provides further validation of its therapeutic potential as a treatment for a variety of complement-mediated diseases. We congratulate our partner Haisco on this significant achievement and are excited about the opportunity to follow suit in the United States and in the other licensed territories."

Mr. Bentsur concluded, "As expected following an in-licensing transaction that involves a late-stage asset with a multi-billion-dollar market potential, our main focus now is to advance ciprocopan toward a marketing application in the United States and other key territories, with NXP200 and NXP900 driving potential longer-term upside in the oncology segment. The successful $115M follow-on offering recently completed provides the resources necessary to advance our broad development strategy for NXP100 in PNH and other complement-mediated diseases and execute the next stage of development across our oncology portfolio."

Recent Developments

Completed public offering in July 2026 for gross proceeds of $115 million, which includes the exercise of the underwriters’ overallotment. Transaction was anchored by leading healthcare investors and extends our cash runway into 1H 2029.
Ciprocopan (NXP100)
In July 2026, our partner Haisco announced marketing approval of ciprocopan in China for the treatment of patients with PNH previously untreated with complement inhibitors. The marketing application in China for the treatment of PNH patients previously treated with anti C5 therapy is under review.
U.S. regulatory efforts underway; a pre-investigation new drug ("IND") meeting with the Food and Drug Administration ("FDA") followed by IND submission expected in 4Q2026.
NXP200
Phase 1b in China in patients with BRAF-mutated solid tumors is ongoing.
Oral presentation of additional clinical data generated by Haisco will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference (Madrid, Spain, October 23–27, 2026).
U.S. regulatory efforts underway; IND submission expected in 4Q2026.
NXP900
With the shift in corporate focus towards the development of ciprocopan, the NXP900 clinical development will now continue with the promising, higher potential impact, combination opportunities:
Non-small cell lung cancer (NSCLC): the clinical trial evaluating the combination of NXP900 plus osimertinib (Tagrisso) in patients with NSCLC EGFR+ who initially responded to, and later progressed on, osimertinib, is ongoing, and we expect to provide an update by the end of this year. The initiation of the combination study of NXP900 with lorlatinib (Lorbrena) in patients with NSCLC ALK+ who initially responded to, and later progressed on, an ALK inhibitor, is expected in 3Q2026.
Pancreatic cancer: Based on in-bound interest from two leading medical centers in the U.S., an investigator-sponsored trial (IST) is planned to evaluate the combination of NXP900 plus daraxonrasib in patients with pancreatic cancer at these centers. Study initiation is contingent on FDA approval and availability of daraxonrasib.

Second Quarter 2026 Financial Results

Cash, and cash equivalents were $22.2 million as of June 30, 2026, compared to $31.6 million as of December 31, 2025. In July, the Company raised $115 million in gross proceeds in a follow-on offering anchored by leading healthcare investors.

The Company’s net loss was $7.0 million for the three months ended June 30, 2026, compared to $6.3 million for the three months ended June 30, 2025, an increase in net loss of $0.7 million. Non-cash stock-based compensation was $1.7 million for the three months ended June 30, 2026, compared to $1.7 million for the three months ended June 30, 2025.

Research and development expenses were $4.7 million for the three months ended June 30, 2026, compared to $3.6 million for the three months ended June 30, 2025, an increase of $1.1 million. The increase was primarily driven by a $0.4 million increase in manufacturing costs, a $0.4 million increase in clinical trial expenses, and a $0.3 million increase in employee compensation and benefits.

General and administrative expenses were $2.5 million for the three months ended June 30, 2026, compared to $3.0 million for the three months ended June 30, 2025, a decrease of $0.5 million. The decrease was primarily driven by a $0.5 million decline in professional and consulting services related to public company expenses.

Finance income was $0.2 million for the three months ended June 30, 2026, and $0.3 million for the three months ended June 30, 2025.

(Press release, Nuvectis Pharma, AUG 4, 2026, View Source [SID1234669683])

On August 4, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it has entered into a Clinical Trial Collaboration and Supply Agreement ("CTCSA") with Eli Lilly & Company ("Lilly"), to evaluate the combination of Amplia’s investigational FAK inhibitor, narmafotinib, with Lilly’s investigational KRAS G12C inhibitor, olomorasib. The Phase 1b/2b clinical trial will evaluate the safety and efficacy of this novel targeted therapy combination as a second line treatment in patients with advanced stage non-small cell lung cancer (NSCLC).

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Under the terms of the CTCSA, Amplia will conduct the study, which is planned to begin in late 2026, at sites in Australia and the USA. Prior to signing the CTCSA, Lilly and Amplia have worked together to finalize an advanced draft clinical study protocol and will now collaborate to finalize both the protocol and other associated clinical study documents.

Dr Chris Burns, Amplia CEO and Managing Director commented, "This collaboration is an exciting new stage in the clinical progression of narmafotinib. We and others have shown that the combination of FAK and KRAS inhibition can lead to improved outcomes, and we are excited to advance with this clinical study to explore the combination potential with olomorasib, Lilly’s leading KRAS G12C inhibitor currently undergoing two global Phase 3 studies in NSCLC."

Strategic significance

The collaboration with Lilly supports and enhances Amplia’s strategy to position narmafotinib as a versatile oncology combination agent with the potential to enhance existing and investigational therapies across several high-value indications.

Leverages narmafotinib’s growing clinical evidence base. This study builds on the promising clinical data from Amplia’s ACCENT study, which has shown that narmafotinib has no significant tolerability burden over chemotherapy alone, together with a range of compelling efficacy signals across responses and survival1.
Expansion into major new indication. The study extends narmafotinib’s clinical development from pancreatic cancer into NSCLC, materially broadening Amplia’s addressable opportunity. The NSCLC market is currently valued at approx. US$31 B and estimated to grow to over US$60 B by 20332. KRAS G12C mutations occur in 13% of patients with NSCLC and 1-3% of patients with other solid tumors.
Capital-efficient growth and enhanced clinical strategy. Lilly’s in-kind supply of olomorasib gives Amplia the ability to efficiently pursue this new program in a high-value indication.
Scientific rationale

Approved KRAS G12C inhibitors such as sotorasib and adagrasib have advanced the treatment of KRAS G12C-mutant NSCLC and are approved for use after prior therapy. However, the clinical benefit of these drugs as single agents is frequently short-lived: response rates are modest and the majority of patients develop resistance, with reported median progression-free survival of only several months. There is therefore a clear and urgent need for strategies that deepen and prolong the benefit of KRAS G12C blockade.

This study combines the potential of Lilly’s potent and highly selective next-generation KRAS G12C inhibitor, olomorasib, with narmafotinib’s role as a suppressor of resistance mechanisms via inhibition of FAK.

Next generation KRAS G12C inhibitor. In studies to date, olomorasib has demonstrated an efficacy and safety profile that has supported later stage clinical development, with Lilly now advancing olomorasib in two separate, global Phase 3 registrational trials.
FAK as a central mediator of resistance to KRAS G12C. A growing body of preclinical and translational research has identified Focal Adhesion Kinase (FAK) as a central mediator of adaptive resistance to KRAS G12C inhibition. This adaptive FAK activation supports tumor cell survival and proliferation, driving resistance through several interconnected mechanisms including FAK-YAP signaling, along with FAK-driven fibrogenesis and remodeling of the tumor microenvironment.
This ASX announcement was approved and authorized for release by the Board of Amplia Therapeutics and Lilly.

(Press release, Amplia Therapeutics, AUG 4, 2026, View Source [SID1234669682])

On August 4, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported additional positive preclinical findings from its ongoing translational immuno-oncology program evaluating SIL204 in human KRAS-mutant cancer cells. The new findings further expand SIL204’s therapeutic profile by demonstrating a coordinated immune-sensitizing effect on tumor cells, reinforcing the scientific rationale for combining SIL204 with anti-PD-(L)1 checkpoint inhibitor therapies. In newly reported studies performed across three human cancer cell lines representing three different KRAS mutations, SIL204 treatment produced statistically significant increases in expression of FAS, a well-established immune "death receptor," and statistically significant reductions in expression of HLA-G, an immune checkpoint that tumors use to evade immune surveillance. The findings, generated in human pancreatic (KRAS G12D) and non-small cell lung cancer (NSCLC; KRAS G12V and G12C) cell lines, build on the Company’s previously reported MHC-I upregulation data announced in May 2026, and further support SIL204’s potential to act as a multi-mechanism immune sensitizer in KRAS-driven tumors.

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"These new findings meaningfully extend and reinforce the immuno-oncology profile of SIL204 that we first reported in May," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "In one integrated dataset, we are now seeing that SIL204 modulates three of the most important mechanisms by which KRAS-driven tumors evade the immune system – upregulating antigen presentation via MHC-I, upregulating FAS to restore sensitivity to immune-mediated cell death, and downregulating the HLA-G immune checkpoint to remove a key inhibitory signal to immune cells. SIL204 is producing this coordinated immune-sensitizing effect across multiple KRAS mutations and both of the largest KRAS-driven tumor types. We believe this profile supports the rationale for further evaluation of SIL204 in combination with anti-PD-(L)1 checkpoint inhibitor therapies, particularly in indications like pancreatic cancer where these agents have historically shown limited single-agent efficacy."

FAS (also known as CD95) is a cell surface death receptor whose engagement by Fas ligand (FasL) – which is expressed on activated CD8+ T cells and natural killer (NK) cells – triggers programmed cell death of the target cell. Cancer cells, and KRAS-driven tumors in particular, commonly downregulate FAS to evade immune-mediated killing. Recent research published in Developmental Cell (Cell Press) has demonstrated that elimination of oncogenic KRAS in genetic mouse models of pancreatic ductal adenocarcinoma restores FAS expression and enables FasL-expressing CD8+ T cells to eradicate KRAS-driven tumors.¹ In the newly reported Silexion study, SIL204 treatment produced statistically significant, dose-dependent increases in FAS expression at 72 hours in human KRAS G12D-mutant pancreatic cancer cells (PK59; up to approximately 2-fold, P<0.0001 vs. control) and in KRAS G12V-mutant NSCLC cells (CORL23; P<0.05 vs. control).

HLA-G is a non-classical HLA class I molecule that functions as a potent immune checkpoint. When expressed on tumor cells, HLA-G binds inhibitory receptors – including ILT-2 (LILRB1), ILT-4 (LILRB2), and KIR2DL4 – on CD8+ T cells, NK cells, and myeloid immune cells, suppressing their anti-tumor activity and enabling immune escape.² HLA-G is a recognized and increasingly prominent drug target in oncology, with multiple HLA-G-directed programs currently in clinical development in advanced solid tumors. In the newly reported study, SIL204 treatment produced statistically significant, dose-dependent reductions in HLA-G expression in human KRAS G12C-mutant NSCLC cells (NCI-H358; P<0.001 at 24 hours and P<0.01 at 72 hours vs. control at the 200 nM dose), with additional reductions observed in KRAS G12D-mutant pancreatic and KRAS G12V-mutant NSCLC cells.

Taken together with the Company’s previously reported May 2026 findings demonstrating statistically significant upregulation of MHC-I (HLA-ABC) in KRAS G12R-mutant pancreatic cancer cells, these new data support a coordinated immune-sensitization signature across three key immune pathways. The immune-modulatory effects have now been observed across four distinct KRAS mutations (G12D, G12V, G12C, and G12R) in both pancreatic and non-small cell lung cancer models, reinforcing the potential applicability of SIL204’s mechanism across the largest KRAS-driven cancer patient populations.

The findings arrive at a moment when the oncology field is actively exploring combinations of KRAS-directed therapies with immune checkpoint inhibitors, with recent academic and industry work demonstrating that combining KRAS inhibition with anti-PD-1 or anti-PD-L1 agents can produce sustained tumor regression and reprogramming of the tumor microenvironment in KRAS-driven cancers.³ Pancreatic ductal adenocarcinoma and KRAS-mutant NSCLC together represent the largest KRAS-driven patient populations, with KRAS mutations present in approximately 90% of pancreatic cancers and 30–35% of lung adenocarcinomas. Immune checkpoint inhibitors have shown limited single-agent efficacy in pancreatic cancer and variable response rates in KRAS-mutant NSCLC, driving substantial scientific and commercial interest in strategies capable of converting "immunologically cold" tumor phenotypes into more immunotherapy-responsive tumors. The Company believes these findings provide additional translational support for SIL204’s ongoing Phase 2/3 clinical development.

(Press release, Silexion Therapeutics, AUG 4, 2026, View Source [SID1234669681])

On August 4, 2026 Forlong Biotechnology, a clinical-stage biotech company focused on developing transformative cytokine therapies for patients with severe unmet needs, reported approval to initiate a Phase I study of FL115 subcutaneous injection (administered once every three weeks) in patients with advanced solid tumors in Australia. The study has been approved under Australia’s Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme, following review by the Human Research Ethics Committee (HREC).

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FL115, an engineered IL-15/IL-15Rα-Fbody fusion protein, has been evaluated as a monotherapy administered via IV infusion in two Phase I studies in patients with advanced solid tumors. These studies demonstrated a favorable safety profile along with preliminary clinical efficacy, supported by significant and sustained expansion of NK and CD8+ T cells, as well as a strong, transient induction of IFN-γ. Clinical benefit has been observed, with 3 patients remaining on treatment (one patient with stable disease and two patients with confirmed partial response) over 12 months.

Compared with IV infusion, subcutaneous administration of FL115 has been shown in preclinical studies to lower Cmax by more than 20-fold while significantly extending meaningful exposure duration, with bioavailability of 60% or higher and no significant gross skin irritation. Such a profile may enhance clinical efficacy through stronger NK and T cell stimulation, while also improving clinical safety by reducing the release of certain cytokines.

"FL115 monotherapy via IV infusion has demonstrated good safety and tolerability, with early signs of potent anti-tumor activity in Phase I studies in patients with heavily-pretreated solid tumors," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology. "We expect the subcutaneous formulation of FL115, dosed once every three weeks, to further improve the safety and efficacy profile, as well as convenience for patients — continuing to establish FL115 as a potential best-in-class IL-15 superagonist and, ultimately, bringing new treatment options to cancer patients in need."

About FL115

FL115 is an engineered IL-15/IL-15Rα-Fbody fusion protein designed to enhance anti-tumor immunity through IL-15-mediated signaling on NK and CD8+ T cells, while minimizing the complexity associated with an Fc domain. FL115 has demonstrated significant anti-tumor activity in vivo, both as a monotherapy and in combination therapy, and can be manufactured through a robust, efficient process with excellent product stability. Clinically, FL115 has shown a favorable safety profile and preliminary clinical responses as a monotherapy, and has best-in-class potential to synergize with current and emerging T cell–targeting immunotherapies through combination approaches that could meaningfully improve treatment outcomes for patients.

FL115 is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase II clinical trial evaluating safety and preliminary efficacy in patients with non-muscle invasive bladder cancer (NMIBC), and in combination with an anti-PD-1 monoclonal antibody in a Phase I clinical trial evaluating safety and preliminary efficacy in patients with advanced solid tumors. A Phase I clinical trial of FL115 subcutaneous injection is also being initiated in Australia.

(Press release, Forlong Biotechnology, AUG 4, 2026, View Source [SID1234669680])