On October 22, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech") reported a clinical trial collaboration and supply agreement with Gilead Sciences Inc. ("Gilead") to evaluate pumitamig in combination with the TROP2-directed antibody-drug conjugate ("ADC") sacituzumab govitecan (Trodelvy) as first-line treatment for patients with locally advanced or metastatic PD-L1 low or negative triple-negative breast cancer ("TNBC"). Pumitamig is an investigational bispecific immunomodulator designed to cooperatively bind to PD-L1 and VEGF-A that is being jointly developed by BioNTech and Bristol Myers Squibb ("BMS").

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ROSETTA Breast-01 is a global, double-blinded Phase 3 clinical trial (NCT07173751) currently evaluating pumitamig in combination with chemotherapy versus chemotherapy in patients with locally advanced or metastatic PD-L1 low or negative TNBC (CPS < 10), initiated based on positive results from a global Phase 2 trial. In line with the evolving treatment landscape in this indication, BioNTech and BMS plan to adapt ROSETTA Breast-01 replacing chemotherapy with sacituzumab govitecan, pending regulatory authority approval, to ensure that patients are receiving the latest standard of care treatment.

Under the terms of the agreement, BioNTech will continue to sponsor and lead the ROSETTA Breast-01 trial. Gilead will supply sacituzumab govitecan for the combination trial.

"When the ROSETTA Breast-01 trial was initiated, chemotherapy was the only option for patients with PD-L1 negative advanced TNBC. While chemotherapy remains a standard first-line option, TROP2-directed ADCs like sacituzumab govitecan are quickly becoming the new global standard of care. I am excited to evaluate the combination of pumitamig and sacituzumab govitecan in the ROSETTA Breast-01 trial to potentially further amplify the already meaningful improvement in patient outcomes that sacituzumab govitecan has demonstrated over chemotherapy," said Peter Schmid, M.D., Ph.D., Lead Investigator and Director of the Breast Cancer Centre at St. Bartholomew’s Hospital.

Pumitamig is currently being investigated in seven ongoing global Phase 3 trials and 10+ Phase 2 novel-novel combination trials. ROSETTA Breast-01 will be the first global Phase 3 trial of pumitamig in combination with an ADC. BioNTech and Bristol Myers Squibb plan to evaluate the full potential of pumitamig in additional Phase 3 novel combination trials in multiple solid tumors, leveraging their broad oncology pipelines and exploring other potential additional collaborations.

"We aim to maximize potential benefit for patients with triple-negative breast cancer. Adapting ROSETTA Breast-01 to reflect the evolving standard of care gives the trial the best chance to inform clinical practice and, ultimately, treatment decisions for patients," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Combining pumitamig as a potential backbone with complementary modalities such as ADCs is central to our therapeutic approach. Sacituzumab govitecan has advanced first-line treatment of triple-negative breast cancer. By combining pumitamig and sacituzumab govitecan, we aim to determine whether this approach can further improve outcomes of patients."

The use of pumitamig and sacituzumab govitecan in patients with first-line PD-L1 negative metastatic TNBC is investigational, and the safety and efficacy of this combination has not been established.

About Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC), which is defined by a lack of hormone receptors (estrogen or progesterone) and HER2 protein, accounts for about 10-15% of all invasive breast cancer cases.1 It is an aggressive type of breast cancer that tends to grow and spread faster and has a worse prognosis compared to other breast cancer types. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. The 5-year survival rate for patients with metastatic TNBC is only 15%, emphasizing the need for new treatment options.1

About Pumitamig
Pumitamig is an investigational bispecific immunomodulator, jointly developed by BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is aimed at restoring the immune system’s ability to recognize and destroy tumor cells while simultaneously cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), preventing them from growing and proliferating. By anchoring to PD-L1 receptors on tumor cells, we believe pumitamig localizes VEGF-A blockade within the tumor microenvironment, potentially enhancing antitumor activity while minimizing systemic exposure.

More than 4,000 patients have been treated with pumitamig in clinical trials to date. Seven global Phase 3 trials with registrational potential are currently ongoing, evaluating pumitamig plus chemotherapy compared to standard of care treatments, in first-line small cell lung cancer (ROSETTA Lung-01, NCT06712355); first-line non-small cell lung cancer (ROSETTA Lung-02, NCT06712316); unresectable stage III non-small cell lung cancer (ROSETTA Lung-201, NCT07361497); first-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA Lung-202, NCT07361510); first-line triple-negative breast cancer (ROSETTA Breast-01, NCT07173751); first-line microsatellite stable colorectal cancer (ROSETTA CRC-203, NCT07221357); and first-line gastric cancer (ROSETTA Gastric-204, NCT07221149). Pumitamig is also being explored in 10+ novel-novel combination trials with ADCs and other novel modalities, with the aim of expanding its role across tumor types and identifying additional pivotal opportunities.

(Press release, BioNTech, OCT 22, 2026, View Source [SID1234673668])

On October 22, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the European Commission (EC) has granted Marketing Authorization for PADCEVTM (enfortumab vedotin), in combination with Keytruda (pembrolizumab), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy as adjuvant treatment (after surgery), for adults with resectable muscle-invasive bladder cancer (MIBC) in the European Union (EU), regardless of cisplatin eligibility.

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The approval is based on results from the Phase 3 EV-304 clinical trial (KEYNOTE-B15)1 and expands the existing EU indication for cisplatin-ineligible adults established through EV-303 (KEYNOTE-905). The combination is now approved for adults with resectable MIBC, regardless of cisplatin eligibility.

Matthew D. Galsky, M.D., Mount Sinai Tisch Cancer Center, Icahn School of Medicine at Mount Sinai, New York, and an EV-304 Principal Investigator
"For cisplatin-eligible patients with resectable muscle-invasive bladder cancer, neoadjuvant cisplatin-based chemotherapy has been an established treatment approach for many years. With this approval, physicians now have a regimen option shown to significantly reduce the risk of recurrence and improve overall survival, without cisplatin-based chemotherapy, providing greater flexibility when planning care for appropriate patients."

MIBC is an advanced, aggressive form of bladder cancer associated with substantial risk of recurrence and disease progression, even though patients are treated with curative intent.2,3 For cisplatin-eligible adults with resectable MIBC, neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy has been a standard treatment approach; however, recurrence remains a significant challenge, with just under half of patients experiencing disease recurrence within five years.2

In EV-304, neoadjuvant enfortumab vedotin plus pembrolizumab followed by continued adjuvant treatment after radical cystectomy significantly improved Event-Free Survival (EFS) and Overall Survival (OS) compared with neoadjuvant gemcitabine and cisplatin chemotherapy in cisplatin-eligible adults with MIBC. The combination reduced the risk of tumor recurrence, progression, or death by 47% (Hazard Ratio (HR) 0.53; CI, 95%, 0.41–0.70; 1-sided p<0.0001) and reduced the risk of death by 35% (HR 0.65; 95% CI, 0.48-0.89; 1-sided p=0.0029).1 The combination also demonstrated a pathological complete response (pCR) rate of 55.8% compared with 32.5% with neoadjuvant chemotherapy at the time of surgery (estimated difference 23.4%; 95% CI 16.7-29.8; 1-sided p<0.0001).1

Moitreyee Chatterjee-Kishore, Ph.D., MBA, Executive Vice President and Head of Oncology Development, Astellas
"The EV-304 results demonstrate the potential to change the treatment trajectory for people with resectable muscle-invasive bladder cancer by bringing an effective perioperative approach into an earlier stage of disease. This approval, together with the existing indication for cisplatin-ineligible adults, enables a consistent treatment approach with enfortumab vedotin plus pembrolizumab for adults with resectable muscle-invasive bladder cancer in the EU and reinforces our commitment to advancing care across urothelial cancer."

The safety profile in EV-304 was consistent with the known profiles of the individual medicines, and no new safety signals were observed.1 Grade ≥3 adverse events due to any cause occurred in 75.7% of patients treated with perioperative enfortumab vedotin plus pembrolizumab compared to 67.2% of patients treated with neoadjuvant chemotherapy.1

Astellas is working closely with regulatory authorities and health technology assessment bodies across the European Union to support patient access following approval.

Astellas has already reflected the impact of the EC approval in its financial forecast for the current fiscal year ending March 31, 2027.

About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.4 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).4

Enfortumab vedotin in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is also approved as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) regardless of eligibility for cisplatin-containing chemotherapy in the United States.

Additionally, enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, Japan, and a number of other countries around the world. In the EU, the combination is approved for the treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.

About the EV-304/KEYNOTE-B15 Trial
The EV-304 trial is an ongoing, open-label, randomized, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab versus neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with MIBC who are eligible for cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant (before and after surgery) enfortumab vedotin in combination with pembrolizumab (arm A) or neoadjuvant chemotherapy (arm B). Curative-intent surgery (cystectomy) was performed in both arms. Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab, split before and after surgery.

The primary endpoint of this trial is EFS, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on BICR or death due to any cause. Key secondary endpoints include OS and pCR rate.

(Press release, Astellas, OCT 22, 2026, View Source [SID1234673667])

On October 22, 2026 argenx SE (Euronext & Nasdaq: ARGX), the immunology innovation company, reported its third quarter 2026 results and provided a business update.

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"The story of argenx is one of continued innovation, growth and impact," said Karen Massey, Chief Executive Officer. "VYVGART is the foundation of our business and continues to deliver strong performance across gMG and CIDP, with significant opportunity still ahead as we reach more patients, expand into new indications, and advance the next wave of FcRn medicines. The positive results from our Phase 3 ALKIVIA study further reinforce the potential of VYVGART beyond neurology, and underscore how much more it can deliver for patients. The upcoming Phase 3 readout for empasiprubart in MMN, the advancement of FB102, and progress across our emerging immunology pipeline are bringing the next chapter of argenx into focus as we build a global immunology innovator positioned for durable growth and value creation well beyond Vision 2030."

Vision 2030

argenx remains on track to achieve its ‘Vision 2030’ anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications, and progress five pipeline candidates into registrational development by 2030.

Realizing the full potential of VYVGART and advancing FcRn leadership

VYVGART (IV: efgartigimod alfa-fcab; SC: efgartigimod alfa and hyaluronidase-qvfc) is the first-and-only approved treatment for all adult patients living with generalized myasthenia gravis (gMG). It is also approved for chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan. Building on VYVGART’s leadership in MG and CIDP, argenx is progressing multiple label and indication expansions, exploring VYVGART’s potential in additional autoimmune diseases through proof-of-concept studies, and advancing next-generation FcRn molecules and delivery modalities.
•Generated $1.7 billion in global product net sales in the third quarter of 2026, representing 54% year-over-year growth and 13% quarter-over-quarter growth
•Submitted a Supplemental Biologics License Application (sBLA) for VYVGART in ocular myasthenia gravis (oMG) to the U.S. Food and Drug Administration (FDA)
•sBLA for VYVGART and VYVGART Hytrulo in pediatric gMG accepted for priority review by the FDA, with a PDUFA target action date in February 2027
•VYVGART Hytrulo autoinjector expected to launch in second half of 2027 for all approved indications
•Reported positive Phase 3 ALKIVIA results with consistent and clinically meaningful treatment effects observed across immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM); sBLA for VYVGART Hytrulo in IMNM on track for submission by year-end 2026, supported by Breakthrough Therapy Designation, with plans to conduct an additional registrational study in DM.
•Topline results from Phase 3 ADVANCE-NEXT study in primary ITP expected in first half of 2027
•Phase 3 VitaliThy studies in Graves’ disease ongoing;
•Advancing the future FcRn portfolio, including Phase 3-ready ARGX-213, designed for monthly dosing, and ARGX-124 currently in Phase 1 development

Advancing empasiprubart, argenx’s second pipeline-in-a-product opportunity

Empasiprubart (anti-C2) is argenx’s second pipeline-in-a-product opportunity and is being evaluated in Phase 3 studies in multifocal motor neuropathy (MMN) and CIDP, with additional Phase 2 studies exploring its potential in other indications and in combination with VYVGART in gMG.

•Topline results from the Phase 3 EMPASSION study (MMN) expected in December 2026
•Topline results from Phase 3 EMVIGORATE and EMNERGIZE studies in CIDP anticipated in the second half of 2027
•Phase 2 ADAPT-Forward platform study in gMG ongoing, evaluating empasiprubart as an add-on to efgartigimod and as monotherapy to support combination development pathway

Delivering next wave of immunology innovation

Beyond the FcRn portfolio and empasiprubart, argenx is advancing a differentiated immunology pipeline that includes FB102 (CD122), adimanebart (MuSK), ARGX-121 (IgA), ARGX-109 (IL-6), TSP-101 (Fn14), ARGX-118 (Galectin-10) and ARGX-125 (undisclosed target), together with additional candidates emerging from the Immunology Innovation Program. These programs support argenx’s ambition to build multiple pillars of sustainable growth beyond Vision 2030.

•Advancing FB102 to Phase 3 in celiac disease based on positive Phase 2 results, with ongoing programs in alopecia areata and vitiligo and potential across other autoimmune diseases
•Phase 3 study of adimanebart in congenital myasthenic syndromes (CMS) expected to begin in 2026; Phase 2 in spinal muscular atrophy (SMA) ongoing
•Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) ongoing
•Advancing Phase 1 development of TSP-101, ARGX-118 and ARGX-125

THIRD QUARTER 2026 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS
Three Months Ended Nine Months Ended
September 30, September 30,
(in millions of $ except for per share data) 2026 2025 2026 2025
Product net sales $ 1,721 $ 1,127 $ 4,534 $ 2,866
Other operating income 30 24 71 60
Total operating income $ 1,751 $ 1,151 $ 4,605 $ 2,926
Cost of sales $ (165) $ (109) $ (431) $ (301)
Research and development expenses* (503) (359) (1,432) (1,001)
Selling, general and administrative expenses (598) (336) (1,370) (937)
Total operating expenses $ (1,266) $ (805) $ (3,233) $ (2,240)
Operating profit $ 486 $ 346 $ 1,372 $ 686
Financial income $ 45 $ 43 $ 137 $ 118
Financial expense (1) (1) (3) (3)
Exchange gains/(losses) 8 (2) (11) 74
Profit for the period before taxes $ 538 $ 386 $ 1,495 $ 875
Income tax expense $ (32) $ (42) $ (151) $ (116)
Profit for the period $ 506 $ 344 $ 1,344 $ 759
Profit for the period attributable to:
Owners of the parent $ 506 $ 344 $ 1,344 $ 759
Weighted average number of shares used for basic profit per share 62,735,385 61,371,508 62,370,746 61,147,873
Basic profit per share (in $) 8.07 5.61 21.54 12.41
Weighted average number of shares used for diluted profit per share 64,886,406 66,441,326 64,578,235 65,944,952
Diluted profit per share (in $) 7.80 5.18 20.81 11.51

DETAILS OF THE FINANCIAL RESULTS
Total operating income for the three and nine months ended September 30, 2026 was $1.8 billion and $4.6 billion, respectively, compared to $1.2 billion and $2.9 billion, respectively, for the same periods in 2025, and mainly consisted of:
•Product net sales of VYVGART for the three and nine months ended September 30, 2026, were $1.7 billion and $4.5 billion, respectively, compared to $1.1 billion and $2.9 billion, respectively, for the same periods in 2025.

•Other operating income for the three and nine months ended September 30, 2026 was $30 million and $71 million, respectively, compared to $24 million and $60 million, respectively, for the same periods in 2025. The other operating income in these periods primarily related to research and development tax incentives and payroll tax rebates.
Total operating expenses for the three and nine months ended September 30, 2026 were $1.3 billion and $3.2 billion, respectively, compared to $0.8 billion and $2.2 billion, respectively, for the same periods in 2025, and mainly consisted of:
•Cost of sales for the three and nine months ended September 30, 2026 was $165 million and $431 million, respectively, compared to $109 million and $301 million, respectively, for the same periods in 2025. The cost of sales was related to the sale of VYVGART.

•Research and development expenses for the three and nine months ended September 30, 2026 were $0.5 billion and $1.4 billion, respectively, compared to $0.4 billion and $1.0 billion, respectively, for the same periods in 2025. The research and development expenses mainly related to advancing efgartigimod, empasiprubart, adimanebart and FB102 across multiple registrational studies, plus early-stage pipeline and preclinical programs.
•Selling, general and administrative expenses for the three and nine months ended September 30, 2026 were $0.6 billion and $1.4 billion, respectively, compared to $0.3 billion and $0.9 billion, respectively, for the same periods in 2025. The selling, general and administrative expenses mainly related to professional and marketing fees linked to the global commercialization of the VYVGART franchise, and personnel expenses. Selling, general and administrative expenses for the three- and nine-month periods ended September 30, 2026 included approximately $150 million of acquisition-related expenses associated with the Company’s acquisition of Forte Biosciences Inc.
Financial income for the three and nine months ended September 30, 2026 was $45 million and $137 million, respectively, compared to $43 million and $118 million, respectively, for the same periods in 2025.
Exchange gains/losses for the three and nine months ended September 30, 2026 were an $8 million gain and an $11 million loss, respectively, compared to a $2 million loss and a $74 million gain, respectively, for the same periods in 2025.
Income tax for the three- and nine-month periods ended September 30, 2026 and 2025 is detailed below:
Three Months Ended
Nine Months Ended
September 30, September 30,
(in millions of $) 2026 2025 2026 2025
Current tax expense
$ (129) $ (52) $ (359) $ (122)
Deferred tax benefit
97 10 208 6
Income tax expense $ (32) $ (42) $ (151) $ (116)

Profit for the three- and nine-month periods ended September 30, 2026 was $0.5 billion and $1.3 billion, respectively, compared to $0.3 billion and $0.8 billion, respectively, for the same periods in 2025. The basic profit per share was $8.07 for the three months ended September 30, 2026, compared to $5.61 for the same period in 2025. The basic profit per share was $21.54 for the nine months ended September 30, 2026, compared to $12.41 for the same period in 2025.

Cash, cash equivalents and current financial assets1 consisted of $2.6 billion in cash and cash equivalents and $1.1 billion in current financial assets which totaled $3.7 billion as of September 30, 2026 after paying approximately $2.1 billion for the acquisition of Forte Biosciences Inc., net of acquired cash, compared to $3.5 billion in cash and cash equivalents and $0.9 billion in current financial assets which totaled $4.4 billion as of December 31, 2025.

FULL YEAR EXPECTATIONS

Combined R&D and SG&A expenses are now expected to be approximately $4 billion for 2026, including the Forte transaction-related costs.

EXPECTED FINANCIAL CALENDAR
•February 25, 2027: Full-year 2026 Financial Results and Fourth Quarter 2026 Business Update
•April 29, 2027: First Quarter 2027 Financial Results and Business Update
•July 22, 2027: Half Year and Second Quarter 2027 Financial Results and Business Update
•October 21, 2027: Third Quarter 2027 Financial Results and Business Update

CONFERENCE CALL DETAILS
The third quarter 2026 financial results and business update will be discussed during a conference call and webcast presentation today at 2:30 PM CET/8:30 AM ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors.

Participants can access the conference call by dialing 800-590-8290 (United States and Canada) or 240-690-8800 (International). Country specific dial-in numbers are listed below:
Belgium 32 2290 4635
France 33 172 001717
Netherlands 31 20 795 2683
United Kingdom 44 203 393 1560
Japan 81 3 4520 9761
Switzerland 41 43 210 51 68

Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call.

A replay of the webcast will be available on the argenx website.

(Press release, argenx, OCT 22, 2026, View Source [SID1234673666])

On October 22, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the signing of an MOU in Seoul, South Korea, with Samsung Medical Center (SMC), regarding a potential clinical trial in pancreatic cancer patients. Any such trial would be subject to regulatory and ethics committee approvals.

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Pancreatic cancer is one of Korea’s deadliest cancers. It is now the country’s fourth leading cause of cancer death, and unlike most cancers in Korea, its death rate has continued to rise. In 2023, 9,748 Koreans were diagnosed with the disease, and its five-year relative survival rate of 17.0% is the lowest of any cancer in the country. Fewer than one in six patients are diagnosed while the cancer is still confined to the pancreas, and more than four in ten are diagnosed only after it has already spread to distant organs.

SMC is ranked fifth in the world and number one in Korea in oncology. Its Pancreatobiliary Cancer Center combines a multidisciplinary team, a fast-track pathway for diagnosis and treatment, and a high-volume surgical program that has performed more than 4,000 pancreatectomies for pancreatic cancer between 2008 and 2025. (Courtesy of SMC)

Uzi Sofer, CEO of Alpha Tau, stated: "Signing this MOU with Samsung Medical Center, one of the world’s leading medical centers, is an important step forward in our goal to bring Alpha DaRT to cancer patients wherever they are. With Korea, our pancreatic cancer program could potentially span six countries across North America, Europe, the Middle East and Asia. I am grateful for SMC’s confidence in Alpha Tau and for the opportunity to explore the potential of Alpha DaRT to benefit its patients."

Hee-Chul Kim, EVP of Samsung Medical Center, General Director of Samsung Comprehensive Cancer Center (SCCC), stated: "Pancreatic cancer remains one of the most challenging cancers to treat, and treatment options are limited for many patients. We hope this MOU will help us explore new possibilities for these patients. We will carefully review the clinical application of Alpha DaRT and do our best to strengthen our own research capabilities."

(Press release, Alpha Tau Medical, OCT 22, 2026, View Source [SID1234673665])

On October 22, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company whose principal value driver is a financial interest in the HER2-targeting antibody programme HLX22, reported its interim results for the third quarter of 2026 and provided a business update.

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"During the third quarter we refocused Alligator on its financial interest in HLX22, which is in global Phase 3 development at no development cost to Alligator, and carried out a rights issue providing SEK 58.8 million before issue costs."
Søren Bregenholt, CEO of Alligator Bioscience

BUSINESS UPDATE
HLX22

Development status: Patients are dosed in all participating regions of the global Phase 3 study in first-line HER2-positive gastric and GEJ cancer. Alligator estimates topline data in the second half of 2027, a potential launch in the second half of 2029 and first royalty revenues from around 2030. In breast cancer, regulatory approval has been obtained in China to initiate Phase 2 and Phase 2/3 studies, of which two are actively recruiting.
Scope of the financial interest: Alligator’s interest also extends to products derived from HLX22, including the antibody-drug conjugate HLX49, which is in preclinical development at Henlius. Alligator neither conducts nor controls the programmes.
Mitazalimab

Independent development discontinued: On 23 July 2026 Alligator announced that it would discontinue all further independent development of mitazalimab, including preparations for and support of Phase 3 studies, and refocus on its financial interest in HLX22. Alligator will seek to out-license or divest mitazalimab in the near term and intends to continue to supply mitazalimab to ongoing externally funded investigator-initiated studies, subject to available funding.
Investigator-initiated study in breast cancer: In July 2026 the first patient was dosed in an investigator-initiated study of intratumoral mitazalimab in early-stage breast cancer.
Company / Financial position

Wind-down and organisation: The wind-down is progressing according to plan. The employees affected will leave gradually over the coming four months, and operating expenses will include wind-down costs during this period. After the CEO transition on 1 January 2027, Alligator will operate with a minimal organisation, supported by external consultants. The rights issue proceeds fund the wind-down and a reduced organisation, but not the full period until HLX22 is expected to generate royalty income.
Rights issue and bridge loans: Alligator announced a rights issue of units of approximately SEK 125.6 million before issue costs, which the Extraordinary General Meeting approved on 26 August 2026. Alligator also raised bridge loans of SEK 19 million.
Outcome of the rights issue: The rights issue was subscribed to approximately 17.1 percent, and guarantee commitments covered a further 29.7 percent. Alligator receives SEK 58.8 million before issue costs and repayment of the bridge loans, and the number of shares will increase to 3,568,106,848. In addition, 1,470,000,000 warrants of each of series TO 15 and TO 16 will be issued.
Renegotiated loan from Fenja Capital: The maturity of the Fenja Capital loan was extended to 30 June 2027. On 29 September 2026, as part of the renegotiated loan, Alligator issued 187,795,097 warrants of series 2026/2031 to Fenja Capital free of charge.
FINANCIAL SUMMARY FOR Q3 2026
The financial summaries for the periods ending 30 September 2026 and 30 September 2025 are presented below.

All amounts in MSEK, unless specified Jul–Sep 2026 Jul–Sep 2025 Jan–Sep 2026 Jan–Sep 2025
Net sales 0.2 0.5 0.2 0.5
Operating profit/loss -19.3 -17.3 -73.2 -83.3
Profit/loss for the period -16.7 -12.3 -53.1 -22.3
Cash flow for the period 24.6 -8.8 -20.8 -38.4
Cash and cash equivalents 41.3 25.1 41.3 25.1
Earnings per share before and after dilution*, SEK -0.03 -0.34 -0.09 -1.01
* Adjusted for reverse share split in 2025.
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a webinar on Thursday, 22 October 2026, at 2 p.m. CEST / 8 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the interim report, which will be followed by a Q&A session.

The call will be held in English. Attendees need to register by following this link.

(Press release, Alligator Bioscience, OCT 22, 2026, View Source [SID1234673664])