BioNTech（BNTX）2026年第3四半期決算説明会：がん領域パイプラインと業績見通しの改定

主な要点

• BioNTechが発表した2026年第3四半期の売上高は、主に新型コロナウイルスワクチンの需要低下により、前年同期の15億ユーロから減少して13億ユーロとなりました。当四半期には、Pumitamigに関するBMSとの提携による6億1,300万ユーロが含まれています。
• 同社は2026年通期の売上高見通しを17億〜19億ユーロに更新しました。調整後研究開発費の見通しは20億〜23億ユーロ、調整後販売管理費の見通しは7億〜8億ユーロで据え置いています。
• 四半期末時点の現金、現金同等物および有価証券投資の合計は162億ユーロでした。BioNTechは9月30日時点で、自社株買いプログラムに基づき約500万株を買い戻していました。
• 転移性扁平上皮非小細胞肺がんにおけるgotistobartの非ピボタルデータの更新では、全生存期間（OS）の中央値がドセタキセルの10か月に対して18.5か月となり、ハザード比は0.56を示しました。ピボタル部分の最初の小括分析（中間解析）は年内に予定されています。
• PumitamigとB7-H3標的ADCの併用療法は、小細胞肺がんにおいて、一次治療で92%、二次治療で76%、三次治療以降で52%の客観的奏効率を示しました。間質性肺疾患の発症率は2.9%でした。
• パイプラインにおけるリスクは依然として重大です。大腸がんを対象としたmRNA試験は中止され、BNT113は無増悪生存期間のエンドポイントを達成できず、TPAMは高い間質性肺疾患発症率を伴う一方で無増悪生存期間の改善は控えめな結果にとどまりました。

主要財務データ

事業および運営業績

Gotistobartがピボタル試験の中間解析へ近づく

既治療の転移性扁平上皮非小細胞肺がんを対象としたグローバル第III相試験の非ピボタル初期パートにおいて、gotistobartは全生存期間の中央値18.5か月を達成し、ドセタキセルの10か月を上回りました。この治療法は死亡リスクを44%低減させ、ハザード比は0.56、追跡期間の中央値は25.4か月でした。

ピボタルパートでも同一のプロトコル選択・除外基準が適用されます。独立データモニタリング委員会が年内に最初の小括分析（中間解析）を評価し、試験の非盲検化を行うか、あるいは2027年に予定されている次回解析まで継続するかを推奨します。

経営陣は、最初の解析は初期段階のものであり、明確なシグナルが得られない可能性があると注意を促しました。ピボタル試験の結果で以前の有益性が確認された場合、同社は2030年までにG7全体で約55,000人の二次治療の扁平上皮非小細胞肺がん患者がこのプログラムの対象になり得ると試算しています。

Pumitamigの併用戦略が拡大

BioNTechは、PD-L1およびVEGF-Aを標的とする二重特異性抗体Pumitamigを、複数の癌腫におけるバックボーン療法候補として位置づけています。経営陣は2026年末までに7つのグローバルピボタル試験が進行中になると予想していますが、これらはいずれもイベント駆動型であり、具体的なデータ判明（リードアウト）の時期は依然として不確実です。

PumitamigとB7-H3標的ADCの併用療法を受けた小細胞肺がん患者71名において、客観的奏効率は一次治療で92%、二次治療で76%、三次治療以降で52%でした。免疫療法による前治療歴のある患者での奏効率は60%、DLL3標的T細胞エンゲージーによる前治療歴のある小サブグループでは88%でした。

用量制限毒性（DLT）は観察されず、併用療法による間質性肺疾患の発症率は2.9%でした。BioNTechは、これらの結果が2027年に開始予定の承認申請に向けた併用試験に活用されると述べています。

一次治療の転移性トリプルネガティブ乳がん患者30名において、PumitamigとTROP-2標的ADCの併用療法は、確認された客観的奏効率76.7%、病勢コントロール率96.7%を示しました。BioNTechはROSETTA Breast-01を最新の標準治療に適応させており、Gileadとの臨床提携を締結しました。計画されているグローバル第III相試験を進める前に、当局の規制承認が引き続き必要です。

mRNAがん領域における明暗交錯する進展

BioNTechとGenentechは、ctDNA陽性のハイリスク第II期または第III期大腸がんにおける術後補助単独療法としてのautogene cevumeranの第II相試験を中止しました。この決定は、独立評価によって全生存期間に数値上の不均衡が確認され、患者登録を継続しても有効性の結果が変わる可能性は低いと結論付けられたことによるものです。新たな安全性シグナルは検出されませんでした。

アテゾリズマブおよび修飾FOLFIRINOXとの併用療法を評価する膵臓がんの第II相試験は患者登録を完了し、計画通り継続されています。

BNT113は、転移性HPV16陽性かつPD-L1発現の頭頸部がんを対象とした主要評価項目（デュアルプライマリーエンドポイント）のうち、無増悪生存期間の項目を達成できませんでした。本試験は引き続き全生存期間の評価を継続します。試験デザインに基づき、無増悪生存期間の結果にかかわらず、統計学的に有意な全生存期間の改善が示されれば、依然としてポジティブな結果とみなされる可能性があります。

乳がんにおけるTPAMの有用性は限定的との見解

HR陽性かつHER2低発現の転移性乳がんを対象とした第III相TPAM試験は、主要評価項目を達成し、統計学的に有意なものの控えめな無増悪生存期間の改善を示しました。全生存期間のデータは未成熟でした。

同試験では、以前の試験よりも高い割合で間質性肺疾患が記録されました。大半の症例はグレード1または2でしたが、少数の患者で重篤な致死的イベントが発生しました。BioNTechとDuality Bioは乳がんおよび子宮体がんのデータ全般を評価中であり、生物学的製剤承認申請（BLA）の可能性を含む今後のステップについて協議しています。

業績予想（ガイダンス）

経営陣は、第3四半期の売上実績が更新後の通期売上高レンジを裏付けるものであると述べました。BioNTechは後期の癌免疫療法、ADC、mRNAプログラムを引き続き優先しているため、費用見通しは変更されていません。

同社は、計画策定が進行中であるとして、2027年の財務見通しを開示しませんでした。

リスクおよび注視事項

• 新型コロナワクチンの需要低下が継続し、四半期売上高の減少をもたらす主な要因となりました。
• gotistobartの最初の小括分析（中間解析）は初期段階であり、経営陣も明確なシグナルが得られない可能性があることを認めています。規制当局との詳細な協議はまだ行われていません。
• Pumitamigのピボタル試験はイベント駆動型であるため、データ判明（リードアウト）の順序や時期の見通しが限られています。
• 大腸がんmRNA試験は、新たな安全性シグナルは検出されなかったものの、全生存期間の不均衡を受けて中止されました。
• BNT113は無増悪生存期間のエンドポイントを達成できず、試験がポジティブな結果となるか否かは今後の全生存期間の解析にかかっています。
• TPAMは乳がんにおいてわずかな有効性の改善を示すにとどまり、少数の致式的イベントを含む高い間質性肺疾患の発症率が示されました。

アナリスト質疑応答のハイライト

• ロシュ／ジェネンテックとの収益構造：1月1日付けで、BioNTechは既存の契約上のオプションに基づき、50:50の費用・利益分配構造からロイヤルティベースの収益構造へと移行します。ロシュ／ジェネンテックが今後の研究開発費を負担し、BioNTechは段階的なロイヤルティを受け取る権利を保持します。具体的なロイヤルティ率は開示されませんでした。
• mRNAへの取り組み：経営陣は、ロシュの決定についてmRNAからの撤退ではなく資本配分の施策であると説明しました。BioNTechは引き続きmRNAがん免疫療法をがん領域の中核プラットフォームと位置づけています。
• Gotistobartの情報開示：BioNTechは、委員会が非盲検化を推奨するか試験の継続を推奨するかにかかわらず、最初の小括分析（中間解析）の結果を開示する予定であると述べました。
• 競合試験からの推測（リードスルー）：経営陣は、エンドポイント、統計的仮定、試験デザイン、層別化、地理的構成の違いから、HARMONi-3試験からROSETTA Lung-02への明確なリードスルー（影響の示唆）はないと考えていると述べました。
• 併用療法の優先順位付け：どのPumitamig併用療法を推し進めるかの決定は、安全性、初期有効性、標準治療の変化、未充足の医療ニーズに基づいて行われます。同社は肺がん、乳がん、消化器がん、および尿路生殖器がんを戦略的重点領域として強調しました。
• 経営陣の交代：本電話会議は、共同創業者のウグル・サヒン（Ugur Sahin）氏とエズレム・テュレジ（Özlem Türeci）氏が現在の執行上の役職として参加する最後の決算電話会議となりました。経営陣は、両氏の新会社に関する議論およびBioNTechの関与の可能性については引き続き任意であり、協議が継続中であると述べました。

決算電話会議トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Welcome to BioNTech's Third Quarter 2026 Earnings Call. I will now hand the call over to Doug Maffei, Vice President of Investor Relations. Please go ahead.

Douglas Maffei

Thank you, operator. Good morning and good afternoon, everyone. Thank you for joining BioNTech's Third Quarter 2026 Earnings Call. As a reminder, the slides we will use during this call and the corresponding press release can be found in the Investors section of our website. Please also note, we will refer to both IFRS and adjusted non-IFRS financials. Our earnings release materials include reconciliation of the adjusted results to the most directly comparable measures based on IFRS accounting standards. On the next slide, you will see our forward-looking statement disclaimer.

Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission, or SEC. Forward-looking statements on this call are subject to significant risks and uncertainties and speak only as of the date of this French call. We undertake no obligation to update or revise any of these statements. On Slide 3, you can find the agenda for today's call. I'm joined by the following members of BioNTech's management team. Ugur Sahin, Chief Executive Officer and co-Founder, Ozlem Tureci, Chief Medical Officer and Co-Founder; and Ramon Zapata, Chief Financial Officer. Also available for the Q&A portion of the call is Annemarie Hanekamp, Chief Commercial Officer.

With this, I'll hand the call over to Ugur.

Ugur Sahin

Thank you, Doug. A warm welcome to everyone joining us today. We have made good progress against our strategic milestones at for 2026, reflecting our continued commitment to advancing our pipeline.

First, we are accelerating the latest development of our oncology assets. At the World Conference on cancer in September, we presented updated overall survival data from Cotistobat from the nonpostage of our global phase 3 car in patients with squamous non-small cell lung cancer who progressed on prior checkpoint in treatment.

Cotistopat nearly doubled median overall survival compared to the standard of care chemotherapy. This is a setting where Shematherapy has remained the standard of care for more than a decade with Patistobat, we aim to provide a chemotherapy 3 monotherapy for patients who progressed after first-line therapy. We are encouraged by the data and the pivotal stage of lil is ongoing. Second, our combination therapy strategy continues to gain momentum. We have really entered into a clinical trial collaboration and supply agreement period to evaluate come in combination with their top 2 directed and hypoderconnugate as first-line treatment for patients with metastatic PD-L1 low or negative propagate breast cancer.

If approved by regulators, this would be the first Phase III trial of [indiscernible] in combination with an antibody drug conjugate and an important milestone advance in our combination of the strategy towards registration. Third, we continue our shift from a platform-centric to a tumor center clinical development approach in cancer with the greatest unmet medical need. At World Lung Congress to presented the first global combination data for any anti-PD-L1 BGF bispecific immunomodulator and an ADC in lung cancer. This combination of Prometic and [indiscernible] demonstrated encouraging early efficacy and manage of safety profile in small cell lung cancer, across lines of treatment, including activity in first-line patients. This data are the signal seeking evidence we set out to generate this year.

Serfclinical responses are encouraging and speak to the potential of novel combinations in listing survival. This data, we have seen support of Phase III for registrational planning for Pomitamex in combination with LED. Looking ahead, BioNTech is well positioned for the next phase of goal with a growing pipeline of potentially registrational price, strong partnerships and financial strength, we are on track to become a diversified multiproduct company by 2030.

Our late state development plan includes multiple pivotal trial out to 2030 and beyond, spanning multiple tumor types and different lines of treatment. As we announced last quarter, Guido Oelkers will take office as CEO by first fit or [indiscernible]. I'm confident that he will bring in his valuable experience to continue advancing Biotech's unique and strong pipeline. Management and Supervisory Board members have been actively engaged in supporting a seamless transition.

We have built BioNTech from a startup into a global biopharmaceutical company with a strong foundation across next-generation immunomodulators, ADCs and messenger. We have also established a distinguished combination therapy strategy in oncology. At the heart of our work is a shared purpose, advancing medical innovation to improve patient lives. Our employees have been instrumental in bringing this purpose to life with the expertise, dedication and commitment.

This is their collective contribution that has turned scientific discovery into meaningful progress for reality and better outcomes for patients. We see significant potential in BioNTech.

As this will be my last earnings call, I would like to thank the many exceptional and dedicated by our team members and leaders, the management and the Supervisory Board, our founding partners, shareholders and collaborators. I would also like to thank the patients, investigators and health care professionals who have been contributing to our trade and our colleagues in the science community. Without all these contributors, none of this would have been possible. The MPF created together to play full innovation for science, medicine and patients is something I will look back on the bid gratitude.

While we hand over the operational responsibility to our successors, Ozlem and I will continue to follow BioNTech's founding shareholders. With this, I will hand over to Ozlem.

Özlem Türeci

Thank you, Ugur. I'm glad to be speaking with everyone today. Our ambition at BioNTech is to address the full continuum of cancer care by exploring the units of immune modulators disease and mRNA cancer immunotherapies. We have defined a tumor type focused strategy to address unmet medical needs in disease areas where our novel combination can extend survival for patients. In the past 2 months, we presented data key conferences for 3 of our leading product candidates Pumitamig, [indiscernible] The data validate the potential clinical benefit across key tumor types, most notably in lung cancer. I will review the data and discuss how it is supportive of a lung cancer franchise, BioNTech is building. .

Lung cancer is an area of high medical need. We have a broad and diverse development approach to maximize our pipeline potential. At the core of our approach is becoming a bispecific immunomodulator targeting PD-L1 and VEGF-A, being developed with our partner, BMS, across multiple tumor types. I will focus on small cell lung cancer first. We are running 4 registrational programs for Pumitamig in combination with standard of care or monotherapy.

In parallel to these registrational trials, we are generating novel novel combination data with our ADCs and our mRNA [indiscernible] to inform the first wave of chemotherapy-free combination trials with rerational intent. Cotistobat is another key candidate of our non-small cell lung cancer strategy. As a reminder, Cotistobat is a selective depleting antibody targeting CTLA4 developed with ONCO-C4. We are advancing Gottubadfue pivotal stage of a global Phase III trial in patients with metastatic squamous non-small cell lung cancer who progressed following plan-based chemotherapy and checkpoint inhibitor treatment. This is a setting with very few effective options and poor prognosis where median survival with current standard of care less than 1 year.

At the World Conference on Lung Cancer, we presented updated overall survival data from the nonpivotal initial part of this trial with a median follow-up of 25.4 months. Median overall survival was 18.5 months with [indiscernible] versus 10 months with docetaxel with a hazard ratio of 0.56. Cotistobat reduced the risk of death by 44% compared with chemotherapy. The observed safety profile of Cotistobad was consistent with previous findings. These results reinforce the potential of cotistubad to provide a significant overall survival benefit as a chemotherapy-free monotherapy in this large underserved patient population in the pivotal part of the trial designed with identical protocol inclusion and exclusion criteria to Stage 1, we anticipate an interim analysis before year-end.

This serves as an early data point ahead of the next preplanned interim analysis next year.

Now turning to small cell lung cancer, where we are evaluating Pumitamig in combination with chemotherapy in combination with a DLL3 T cell engager and in combination with LED in front and later lines. LPD is our B7-H3 targeted ADC developed with Duality Bio. LD's clinical profile positions it as a potentially versatile oncology asset across a wide range of solid tumors. More than 1,000 patients have now been treated with LED across over 10 tumor types including more than 500 patients treated with LED in combination with Pumitamic. This was a global data set from our Phase I/II trial of Pomitamicplus SSD in patients with advanced small cell and non-small cell lung cancer.

This combination brings together 3 independent mechanisms of action. Checkpoint inhibition the GFA neutralization and the tumor cell targeted cytotoxic payload of [indiscernible]. In 71 patients with small cell lung cancer across 4 dose levels, the combination showed a remarkable 92% overall response rate in first line 76% objective response rate in second line and 52% objective response rate in third line and later.

Importantly, we saw activity in patients previously treated with immunotherapy with a 60% objective response rate and in the small group of patients previously treated with a DLL free targeted T cell engager with an encouraging 88% response rate. The safety profile was manageable and consistent with data from each agent individually with limited overlap between Pumitamic and LPD-associated toxicities. No dose-limiting toxicities were observed and the ILD rate for the combination was 2.9%. This combination data support our broader strategy of eval Pumitamig as a potential backbone for convenient regimens of complementary mechanisms. They will have to inform the clean developed strategy to address today's unmet need and tomorrow's evolving small cell lung cancer standard of care. These states have seen in this trial will help guide our novel-novel combination strategy in lung cancer into potential registration with first trials expected to begin in 2027.

[indiscernible] negative breast cancer, our Pumitamig+C combination strategy is now entering the pivotal stage. At ESMO Breast in May, Pumitamig in combination with a TROP-2 targeted ADC showed a confirmed objective response rate of 76.7% and a disease control rate of 96.7% as first-line treatment in 30 patients with metastatic triple-negative breast cancer. This data confirms that Pumitamig combined with the [indiscernible] has a manageable safety profile and warrant further investigation as first-line treatment.

when we initiated Rosetta Breast 01, chemotherapy was the only option for patients with PD-1 negative advanced TNBC. However, in 2026, the standard of care for first-line TNBC shape following updated NCCN and ESMO guidelines as well as the FDA put of crop 2 ADCs. To 2 target ADCs as sacituzumab are quickly becoming the new standard of care. As a result of the evolving treatment landscape, we are adapting Gosebr01 to replace key therapy with such aumo we have entered into a clinical collaboration with Gilead. Pending the green light from regulators, this would be the first global Phase III trial of our PD-L1 BGF biospecific, Pumitamig, in combination with an antibody drug conjugate. Adapting ROSETTA Breast 01 to evolving standard of care give the trial the best chance to inform clinical practice and ultimately treatment decisions for patients.

Moving to mRNA cancer immunotherapies. As announced in August, the decision was made in alignment with Genentech to discontinue the Phase II trial of outogen/sevumuran as adjuvant monotherapy and ctDNA positive stage 2 high-risk or stage III colorectal cancer. This decision followed a review from the independent Data Safety Monitoring Board in which they identified a numerical imbalance in overall survival between the treatment arms in this specific patient population and determined that continuing the trial was unlikely to change the efficacy outcome.

No new safe signals were identified. The Phase II [indiscernible] trial in adjuvant pancreatic care where outogensevumaran is being evaluated in combination with atezolizumab and modified Folfirinox has completed enrollment and continuous as planned. BNT113, our offshore mRNA immunotherapy is being evaluated in a pivotal Phase II/III trial in combination with pembrolizumab versus pembrolizumab alone as first-line treatment for patients with metastatic HPV16-positive PD-L1 expressing head and neck cancer.

In October, we announced top line results from the first prespecified interim analysis of had merit, -- while the trial did not meet its first dual primary end point of progression-free survival, it is continuing as planned to assess the second dual primary end point of overall survival. The independent data committee recommended that the trial continue in accordance with the trial protocol.

As immune mediated antitumor effects, build and deepen over time, analysis of the overall survival endpoint will be critical to fully assess potential office approach to deliver durable benefit for patients with HBD-driven head and neck cancer. Under the trial statistical design, which prespecifies dual primary endpoints of PFS and OS statistically significant improvement in OS would establish a positive trial outcome, irrespective of the PFS result.

BioNTech is leveraging novel combinations with next-generation IO targeted therapies and mRNA cancer immune therapy to maximize pipeline potential and elevate outcomes for patients with solid tumors. The potential of mRNA cancer immunopers in combination regimens like and their ability to induce immune responses that may translate into durable clinical benefit and ultimately prolong survival of patients.

Let me now move to our other late-stage milestones. Recently, we announced that our global Phase III trial evaluated TPAM, an investigational HER2 ADC developed in collaboration with DualTBio in patients with HR-positive HER2 low metastatic breast cancer after endocrine who are chemotherapy-naive, met its primary endpoint demonstrating a statistically can yet modest improvement in progression-free survival.

At this interim analysis for the secondary endpoint of overall survival data were not mature. A higher rate of interstitial disease was reported in this trial compared to prior trials with most cases being Grade 1 and 2. Severe fatal events were reported in a small proportion of patients Otherwise, the overall sea profile was consistent with prior clinical trials and no new safety signals were observed. The available efficacy and safety as of this data cutoff date, suggest that the potential benefit to patients would be limited in the context of the HR for 2 low metastatic breast cancer treatment landscape.

We and Duality Bio are currently discussing the totality of clinical data for trastuzumab pameticanos plus endometrial and breast cancer within the context of the evolving treatment landscape and areas of unmet medical need and will determine the next steps. We and Duality Bio are discussing plans for BLA submission and will update them accordingly.

Looking ahead, we are on track for the first interim analysis for Gotistobart in squamous non-small cell lung cancer before year-end. This will be assessed by the IDMC to recommend whether to unblind the trial or continue to the next preplanned interim analysis. We also various late-stage readouts this year. We also further advanced our late-stage pipeline and initiated 6 Phase retros.

In 2026, we published several data sets from our novel novel programs with more to come. We executed these earlier combination trials to provide the signal-seeking evidence to inform and potentially derisk the move of our combination rights into the pivotal stage. This provides a foundation for advancing BioNTech's growing late-stage oncology pipeline towards first approvals.

With that, I would like to echo Ugur and thank our exceptional team at BioNTech for their connection, for their loyalty and dedication. Building this company together and unforgettable experience from the humble foundations to receiving approval of the first mRNA-based product to creating a diversified oncology pipeline we have today.

My thanks also go to our partners, instigators, regulators, health care professionals and the patients and their families who have placed their trust in us.

Turning the presentation over to our CFO, Ramon Zapata.

Ramón Zapata-Gomez

Thank you, Ozlem, and welcome to everyone joining us. I will start with our third quarter and year-to-date 2026 final results then provide an update on our full year 2026 financial guidance and capital allocation highlights. Note that all figures are in euros unless otherwise stated, beginning with financial performance.

Revenues for the third quarter of 2026 were EUR 1.3 billion compared to EUR 1.5 billion in the prior year third quarter. This decline mainly reflects anticipated lower market demand for our COVID-19 vaccine. As expected, revenue of EUR 613 million were recognized in the quarter from our global strategic partnership with BMS related to the co-development and co-commercialization of our next-generation bispecific antibody candidate Pumitamig.

Adjusted R&D expense for the third quarter of 2026 increased to EUR 579 million from EUR 479 million in the prior year third quarter. The increase reflects greater investment in our prioritized IO and ADC programs, partially offset by lower spending outside of our strategic focus. On an IFRS basis, R&D expenses were EUR 748 million. The additional expenses of EUR 169 million, including impairment losses related to intangible assets, which are outside of our strategic focus.

SG&A expenses for the third quarter of 2026 on an adjusted and IFRS basis were EUR 179 million compared to EUR 149 million in the prior year third quarter. The increase was mainly driven by prelaunch activities for late-stage programs and the commercial buildup as well as our ongoing global initiative to scale processes and ERP infrastructure to optimize operational execution. At the same time, we continue to realize meaningful savings from strategic pipeline prioritization execution and enhance cost discipline across the organization. Our strong financial position of EUR 16.2 billion in cash, cash equivalents and security investments at the end of the third quarter provides the foundation to advance our ambition of becoming a global multiproduct biopharmaceutical company by 2030.

Let's now turn from the third quarter to our 9 months year-to-date 2026 financials. Comparing this year's performance with the same 9-month period of the prior year, drivers are mostly in line with the factors I have described for the quarter. Revenues were EUR 1.5 billion for the year-to-date 2026 compared to EUR 2 billion in the prior year period. Adjusted R&D expenses were EUR 1.6 billion compared to EUR 1.5 billion. Adjusted SG&A expenses came in EUR [indiscernible] million, up from EUR 407 million. Overall, our year-to-date performance is aligned with our expectations. Our revenue performance in the third quarter allows us to rate the midpoint of our previously provided full year 2026 revenue guidance.

Our updated 2026 financial revenue guidance is now EUR 1.7 billion to EUR 1.9 billion. Our adjusted R&D and SG&A expense guidance for 2026 remains unchanged at EUR 2 billion to EUR 2.3 billion and EUR 700 million to EUR 800 million, respectively.

I will now touch on the capital allocation strategy. Our approach remains centered on prioritizing investments towards our highest value opportunities with a focus on advancing late-stage programs to our traditional approvals and launches while investing selectively in earlier-stage innovation. This approach is designed to create diversified revenue streams and lay the foundation for a sustainable long-term oncology business. Our strong balance sheet provides us with the flexibility to complement our portfolio, strengthen our focus areas and access external innovation where we see strong strategic alignment. At the same time, we continue to return capital to shareholders.

Since the implementation of the share buyback program in June, we have repurchased approximately 5 million shares September 30, reflecting our belief in the intrinsic value of BioNTech while maintaining full optionality to advance our pipeline, execute partnerships and pursue corporate development opportunities.

We remain focused on operational efficiency and deplaned resource allocation, optimizing our portfolio, manufacturing footprint and cost structures to focus sources on our highest value priorities. This is reflected in our recently divested J peptide Technologies business, growing manufacturing footprint consolidation, where we continue to assess other areas where we can elevate operational efficiency.

We are also taking steps to simplify our AI optional model and strengthen its integration across BioNTech. We plan to integrate the expertise and capabilities of [indiscernible], our wholly owned AI and machine learning subsidiary into BioNTech's core business. As part of this initiative, we expect to focus element on supporting our strategic objectives, operational processes and innovation priorities. We believe this more integrated approach will reduce complexity and allows us to deploy AI more effectively. Our conviction in mRNA is anchored by over a decade of translational and clinical research as well as deep experience in the field. We continue to advance mRNA cancer immunotherapies and investing them as a key pillar of our oncology strategy, including novel combination approaches intended to maximize the potential of our diversified oncology pipeline.

Irrespective of our conviction in the drug class as such, we optimize the financial structure of our existing collaborations. We have exercised an option in the Roche Genentech BioNTech collaboration agreement under with future R&D costs for this program will be reassigned to Roche Genentech, including assessing the candidate in Arjuma pancreatic ductal adenocarcinoma, PDAC.

BionTech will be eligible to receive royalties. The decision to exercise the option aligns with our broader capital allocation framework as we optimize operational efficiency. With this, we aim for an improved financial structure under the terms of the agreement, which does not affect our ongoing clinical program. This means the ongoing Phase II clinical trial in PDAC continues as planned and we are excited to see more data from this mRNA cancer immunotherapy program.

Taken together, our strong financial position and disciplined capital allocation approach support our long-term objective of becoming a global multiple company, addressing the unmet medical needs of cancer patients worldwide. We remain focused on prioritizing investments that advance our pipeline and support sustainable growth while preserving the financial flexibility to respond to evolving opportunities.

Finally, discussions regarding Ugur and Ozlem's new company and potential contributions from BioNTech remain ongoing. Any potential arrangement will be evaluated based on its strategic rationale and its ability to maximize value for patients and our shareholders. While there is an opportunity for a deal at this stage, it's optional for both parties and not a necessity.

Before I close, since this is the last earnings call that we have with the founders of BioNTech, I would like to wish Ugur and Ozlem all the event in the new venture. I also want to thank them personally for their vision, leadership and extraordinary contributions. Together, they built BioNTech from small area into a global pharmaceutical pioneer. They advance science that has changed lifes around the world and achieved a medical breakthrough, which has entered the history books. We are deeply grateful for everything they have done for this company and the foundation they live is one we are proud to build on.

With that, I will hand it back to the operator to open the call for questions. Thank you.

Operator

[Operator Instructions] Your first question comes from Akash Tiwai from Jefferies.

質疑応答

Akash Tewari

Ugur and Ozmen, really congrats on an amazing tenure at BioNTech, 2 for you. One, is your team more confident on hitting on the first or second interim for [indiscernible]? I know in the prior data, there was kind of a late onset curve separation on OS. So I would love to understand which 1 of these interims investors should be paying more attention to?

And then a bit on cancer vaccine. So it sounds like you're changing the economic agreement with Roche. But I think stepping back, -- what does your team stand in terms of cancer vaccines, especially with the new management team coming forward, do you think that we'll see a doubling down potentially going into a precancerous earlier-stage setting, trying different combination approaches -- or is the Biontic vision really, at this point, focused on [indiscernible] going forward?

Özlem Türeci

Akash, I can take the first question. We are very excited about Gotistobart.And as you know, the pivotal first part of the trial we have seen and just recently reported a near doubling of median OS. We are waiting for the first interim analysis, which will happen this year. The second one will happen next year. I have to admit that the first one is early. So even though we are excited, we will not be disappointed as we cannot see a clear signal.

Ugur Sahin

Thank you, Akash. I will take on the second part of your question that is related to mRNA and our commitment to it. What I would say is that -- the changes in the [indiscernible] collaboration are mainly a resource allocation decision from us as it will give us further flexibility to allocate resources to other priorities programs in our pipeline. That by no means should be understood as a lack of commitment. We continue to be very excited about the, very much looking forward its next milestones and readout.

And in terms of the new management, I think it's a little bit premature to talk about what the priorities would be. What I can mention is that our current strategy and one of the pillar current strategy is to continue to work in -- we have the capabilities. We have the skills and I believe the right to be a very strong participant in the market. And we continue to advance our 113 program, 116 [indiscernible] and between and also some further efforts in early stage on our mRNA platform, be it fixed back or the shelf platform or [indiscernible].

Operator

Your question comes from Mohit Bansal from Wells Fargo.

Mohit Bansal

I just wanted to understand a little bit about the cancer vaccine program. So looking at both [indiscernible] lateral cancer, and they both are relatively IO or immuno lesinuological diseases. So can you help us understand if there is any read-through from colorectal cancer to PDAC -- and how should we think about your confidence in the cancer therapy going forward here?

Özlem Türeci

Thank you, Mohit, for your question. I can give some background to how we see the real from colorectal cancer to PDAC. In principle, these are 2 different questions asked and 2 different experiments. It's correct that both are old tumors and both are tumors with with an occasional burden being more on the lower side.

However, these are on the round entirely different tumor biologies. And also different settings of positioning the vaccine. What I mean with this is that colorectal cancer trial, we have used our vaccine in the monotherapy setting asn an active vaccine and the PDAC setting. It is integrated into chemo therapy and combined with checkpoint inhibition.

Operator

The question comes from Daina Graybosch from Leerink Partners.

Daina Graybosch

I also want to echo my gratitude and congratulations for your next steps, that's for Ugur and Ozlem. My question is on TROP2 ADC. I wonder if you can tell us the status of your own TROP2 ADC, which you had previously licensed from Duality Bio. And how are you thinking about combination of Pumi outside of TNBC. Are you looking at endometrial where Gilead has an ongoing Phase III trial. But what about lung and other indications where competitors are combining their VEGF biospecifics are planning to with their TROP2 ADC/

Özlem Türeci

Yes. Thank you, Daina, for your question. We see our ADC portfolio broader design space to combine with 2 meter. And we have, for all of our ADCs signal-seeking trials in combination with ongoing of indications. This includes our TROP2 ADC but also the others. And we are now at a stage where we have a large body of data -- and our approach is that we are assessing not on a -- with a single ADC lens. But in fact, comparing these different target targeted ADC for their potential to bring clinical benefit in diverse in indifferent indications in combination with Puma. We will be able to be more concrete, which we want to further develop in which indication as a combination.

Unknown Executive

Yes. Thank you, [indiscernible]. I will just also add that in line with our strategy, what we shared before, Pumitamig, we believe that this next-gen bispecific will be the backbone in different settings and cancer types and that we're moving this ahead with our partner, BMS, in chemo combinations, but also to your point, in combination with other assets and ADCs are a core part of that. And we're not only moving those forward with our own portfolio or BMS, but also as you've seen during our announcement at ESMO moving that forward with, in this case, Gilead we're closely monitoring the field. There's been some interesting data including in lung cancer. And if you let our strategic priorities, we're definitely focused with multiple shots on goal lung cancer, breast cancer, but also GI and GU cancer. So we will continue to evaluate, follow the science and then decide which asset is best combined with [indiscernible], we believe transformational benefits can be delivered on top of the chemo benefit we're hoping to see in the first wave of combinations with Pumitamig.

Operator

Your question comes from Tazeen Ahmad from Bank of America.

Tazeen Ahmad

Can I just get some clarification about whether you've had any meetings with FDA on the exact path forward for [indiscernible]. Would love to hear your thoughts on what to expect after you revealed the dateset that's coming up.

And then on the Roche collaboration I was just curious to know you guys have a really strong balance sheet. So what's the real driver of wanting that expense to really be carried by them? And does that, in exchange also give them more influence about the pace of development and indications will go into development.

Özlem Türeci

So I can take the first question, Tazeen. With regard to [indiscernible], we did not have so far detailed discussions with regulatory authorities. We have an understanding how the path forward would be, and we will further refine that on the totality of data we will see in the -- in Part 2 of the trial, and we'll then engaged with regulators. .

Ugur Sahin

And then as, in terms of the Roche collaboration. So -- to be clear, the existing agreement remains in place where we have only exercised a contractual options, where as of January 1, we will transition from a 50-50 cost profit sharing to reality-based economics. So now you're totally true. So we are operating from a position of strength with the balance sheet and the cash that we currently have However, we are also advancing the late stage -- a number of late-stage programs in a way that are now meaningfully needing investment. So this is really and truly a capital allocation decision. We continue to retain potential royalty upside and transitional supply responsibilities to the PDAC program and we continue with the excitement about that program.

But we are now providing that financial flexibility to other pieces of our pipeline. So that is pretty much the reason of why we have exercised this contractual option.

Operator

We will take our next question. Your question is from David Dai from UBS.

Unknown Analyst

And so just on Pumitamig, we have some -- seen some pretty encouraging data, especially from global trials that seem to replicate the efficacy and safety profile of trials. So just curious, what are your latest thinking on the China global traits based on totality of data generated? How should we think about the efficacy and safety translation in the Phase III case of trials in 2027 onwards.?

Özlem Türeci

David, the question was what we are thinking about translation from China or regional into [indiscernible]. Did I get that right?

Unknown Analyst

Yes, that's right. Yes. .

Özlem Türeci

Yes. So I think the class as such, not only poorly, but also put has shown in several cases that there is translation from global functional China data into global data. Our recent data packages or data sets in TNBC and small cell cancer, for example, have shown that so that we are very confident that -- this is something we can rely on. .

Operator

The question is from Asad Haider from Goldman Sachs.

Asad Haider

Maybe just going back to the cancer immunotherapy a little differently. There's now a validation in melanoma for mRNA cancer immunotherapy and the market's rewarding innovation there. So just are you going to shift your strategy to pursue the more validated approaches and tumor types? Just curious as to what tumor types and settings you would be prioritizing. And if I may, on Pumitamig, just with Summit how many 3 data approaching would be interested in your latest thinking on how you're thinking about this readout as it relates to the breeders to your rolling strategy for mix?

Özlem Türeci

I can take the Pumitamig question, did not fully get which trial you were referring to. Could you repear, Asad?

Asad Haider

Yes, sure. Just with the Summit Harmony 3 data approaching, just so as to hear your latest thinking on what this readout means as it relates to the read across to your own development strategy? What are you looking for there? How should we be looking at that readout with respect to how you're thinking about your own development

Özlem Türeci

Yes. Sorry, it was just -- I didn't get that you are referring to the HARMONi-3 trial. So how many free trials is in -- it's in the same month, so we will pay attention. It also is shared with our ROSETTA Lung 2 trial, that is the same patient population is the same comparator However, we have 2 very different studies here, right? They differ in the endpoint, in the [indiscernible] size assumptions in the typical architecture and stratification methods, higher site and country mix. So we don't see that -- we have a clear read-through mechanism from Harmony free to to ROSETTA Lung 2 and irrespective of what we see there, we will stay committed to our studies. And I also have to say that everything we have so far and reported in the Phase II part of this patient population is very encouraging. .

Unknown Executive

And I can speak to the Genentech question on mRNA. And I'll repeat in part what Raman shared during this call already is that our strategy is -- remains focused on mRNA. We see mRNA is a key pillar of our combination -- and while our financial terms in the Genentech collaboration now maybe have eased slightly for the value optimization and capital allocation strategy that Ramon spoke to. -- the actual dynamics of the partnership have not changed.

So -- and as we take forward with our mRNA candidate, 1 to 2 will be in collaboration with our partner, Genentech there.

Operator

The question is from Jessica Fye from JPMorgan.

Jessica Fye

I had a couple. I was hoping you could characterize enrollment progress for the Pumitamig Phase IIIs and touch on your latest expectations for data readouts?

And then coming back to Gotistobart, following up on 1 of the early questions. Will you comment on whether the first interim hits 1 way or the other, once it occurs? And how do you think about the potential commercial opportunity for Gotistobart in second-line squamous 1 small cell?

Özlem Türeci

Jessica, the first question was about Pumitamig readouts and timing for our pivotal studies. Did I get that right?

Tazeen Ahmad

Yes. Yes.

Özlem Türeci

So we have 7 global pivotal studies ongoing by end of this year, and strikes are all event driven. So we cannot predict the exact sequence and timing with confidence. But what I would like to do is to point you to clinical trial scores, where we have timely completion dates supported based on the most current recent data. And according to those primary completion dates, we will see a first-line TNBC in China data then Rosetta lung [indiscernible] around 2029, and then followed by RCCCRC, HCC and the other.

However, the timing, as you know, can move as we studies mature and it may change. The company will update the market when they have enough visibility to do so responsibly.

The second question was about, I think, commercial Gotistobart positioning.

Unknown Executive

Yes. Yes, I can take that one. So as slim already alluded to, we presented an update on the Gotistabart nonpivotal part of our Phase III study with impressive benefit for patients. And as you may know that in this patient setting, for a long time, we haven't seen real improvements. many shots on goal were tried, but many also failed to demonstrate improvement in overall survival. So if the Cotistabart pivotal Part 2 of the pivotal trial confirms the benefit that we've seen to date we believe it could address a meaningful patient population.

Again, where no innovation has been happening for a while. And if you look at the current data, we would estimate around 55,000 patients in second-line squamous non-small cell lung cancer by 2030 in just G7.

So with [indiscernible], we do view Gotistobart as a key asset in our portfolio that can meaningfully contribute to building BioNTech in a multiproduct company on the longer term.

Jessica Fye

Great. And if the first interim passes, would you comment on it one way or the other once that happens. .

Unknown Executive

Yes, we would comment on it 1 way or another as we have disclosed that we're expecting this readout, we would also expect if the IDMC would recommend a study to continue as per Ozlan's earlier comments.

Operator

Your next question comes from [indiscernible] from Evercore ISI.

Unknown Analyst

So on the heels of the encouraging results with [indiscernible] LPD, ESMO, what are the next steps for this combination and what tumor types are you most interested in advancing. And then since others are asking multiple questions, a very quick 1 for you. If iNeST is ultimately successful, what level of royalty would you get from Roche under or post this option you exercise?

Özlem Türeci

So I can take this first question. Before I do that, I would like to thank everyone on the call also on behalf of for your kind words. It was really a pleasure to work with all of you over these years. Cory, you asked for our plans for [indiscernible] Pumitamig combinations and how we want to go ahead. Yes, we are also very excited about the data we presented for small lung cancer and there is lot more to come because we have not fully analyzed the other tumor type cohorts, which are still running. We have not decided on the specific indications setting or timing for pivotal trials yet. Our prioritization and decisions will be data-driven based on the large body of data we have produced over the last couple of months in the different indications. And this will be part of our 2027 milestones, which we will disclose in a couple of months. .

Ugur Sahin

In relation to your question on IMS. So we are not providing specific royalty economics. -- under this option. However, I mean, like all of this is dependent on successful development and then thereafter commercialization. So this is the tiering of royalties that we currently have. But this is as much as we can disclose at the moment.

Operator

Your next question comes from Terence Flynn from Morgan Stanley.

Terence Flynn

Great. It might be a little bit early, but Ramon was just wondering if you can comment broadly on how to think about 2027 numbers, both top and bottom line, just conceptually.

Ramón Zapata-Gomez

Terence, in this, it's a little bit premature to talk about 2027. We are currently working these plans, and we will update all of you at a later stage.

Operator

Your next question comes from Simon Baker from Rothschild & Co Redburn.

Simon Baker

Going back to iNeST and FixVac and development plans, can you thoughts on the recent paper in cell that suggested the potential benefit on efficacy from adding chemotherapy, specifically carboplatin and taxel, you do have chemo in some of these trials. But I just wondered what you thought about the utility and implications of that early work on future development plans for both iNeST and FixVac .

Özlem Türeci

Thank you, Simon, for your question. So with which compounds we combine depends really on the standard of care and backbone, which is used in the respective indication. The data you are quoting shows that combining with chemoprop first of all, feasible and, in fact, can also improve the effect because it supports antigen spreading.

So we do not shy away, and you can see this in our PDAC study, for example, and also in our studies with BNT116 to combine with chemo where it makes sense from a standard of care and -- bone point of view.

Operator

Your next question comes from Yaron Werber from TD Cowen.

Unknown Analyst

This is [indiscernible] on for Yaron. I just want to get your broader thoughts on your some late-stage pipeline. And what you think of as exciting asset beyond premium Navigotistobart? And then also, I know that you're in discussions with your partner on TPAM, but if you could give us any more granularity on how the recent breast cancer results might impact your filing in endometrial cancer and your thoughts for that pivotal registrational plans. Thank you so much.

Özlem Türeci

I did not get question fully. I think 1 part of it was about what we find interesting in our pipeline or exciting beyond Pumitamig and [indiscernible]. So actually, all of our estimates is particularly exciting, and we have a large body of data, which supports this excitement. However, we are also very excited about our -- as in particular, also because, again, there, the excitement is supported by data and which we see across the tumor -- what was the question?

Unknown Executive

I can take that -- the second question is about TPM and potential filings. So -- as Ozlem already mentioned, we're discussing with Duality Bio, the totality of our clinical data for both across endometrial and breast cancer. And we do that, of course, with the mind of making sure that we add both value for patients and patients and shareholders alike. So -- we're looking at the context of the evolving landscape as of unmet medical needs and then we determine next step. So currently, we're discussing a BLA submission, and we will update the market accordingly. .

Operator

We will take our final question. And the final question comes from Jeff Mitchum from Citigroup.

Unknown Analyst

This is [indiscernible]. Maybe just a question on [indiscernible]. I know you guys were testing across the combinations across several ADCs, but emerging data as defer tumor type and partner assets. So I guess I'm just wondering, what criteria will determine which Plum combinations advance most aggressively? And where have the data increase or reduce your conviction so far?

Unknown Executive

So I can take this question. Thank you very much. It's, first of all, as we mentioned several times for buy and tech really data driven. We had a couple of Phase I/II combination data sets out there together with our own ADC portfolio and mRNA portfolio, also BMS or Pamidamic is starting combination work as well as we have several projects now running outside of both BMS and BioNTech's pipeline. So we will await the first data to determine both on safety and early efficacy which candidates and combinations we move forward.

But -- like I mentioned in the previous question, we also continue to monitor the evolving landscape. The speed of the oncology development over the last decade is continued to accelerate, which is amazing news for patients, but also requires also sponsors of study to make sure that by the time data reads out, we still address relevant unmet medical need.

So it's a continuos monitoring, of what is evolving, what is in line with our strategy. As we said, we're focused on lung, breast, GI and GU cancers, and then making sure that the data is in line with those expectations.

All in all, to become a multiproduct company by the time that we enter into 2030.

Operator

Thank you. This concludes today's question-and-answer session and concludes today's conference call. Thank you for participating. You may now disconnect.