On November 18, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payloads for antibody drug conjugates (ADCs), reported the appointment of Kameel D. Farag as its Interim Chief Financial Officer who joined Akari last month. Mr. Farag is a proven biotech and global finance executive with a track record spanning over two decades of scaling innovative biotech companies through transformational growth.

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"We are thrilled to welcome Kameel to Akari, who has hit the ground running, at a pivotal time in our company’s growth," said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. "His deep experience across corporate finance, M&A, and operational build-outs will be instrumental as we accelerate development of our novel ADC platform and advance our lead asset toward the clinic."

Mr. Farag added, "Akari is at the forefront of developing a new class of ADCs designed to disrupt cancer cell survival through RNA splicing modulation. I’m excited to join this talented team and apply my experience to help position Akari for its next phase of growth and value creation."

Mr. Farag joins Akari after having most recently served as Chief Financial Officer and head of business operations at Aspen Neuroscience, where he oversaw tripling the company’s headcount, secured over $150 million in financing, built manufacturing infrastructure, and prepared the company for clinical data and a potential future public offering. Prior to his time at Aspen, Mr. Farag served as SVP Finance at Ionis Pharmaceuticals. As a member of the senior leadership team, he was instrumental in supporting the company’s revenue and profitability growth by building out the finance team, systems and processes to support $1B+ in revenue, multiple marketed products, and a growing wholly-owned pipeline. Earlier in his career, Mr. Farag was with Amgen for more than 16 years, where he held positions of increased leadership, including heading finance for international regions where he focused on driving growth in emerging markets while growing profitability in established markets.

Mr. Farag earned his bachelor’s degree in Business & Economics at University of California, Santa Barbara.

(Press release, Akari Therapeutics, NOV 18, 2025, View Source [SID1234660079])

On November 18, 2025 Biogen Inc. (Nasdaq: BIIB) reported that Alisha Alaimo, President, Head of North America, will participate in a fireside chat during the 8th Annual Evercore Healthcare Conference. The webcast will be live on Tuesday, Dec 2, 2025, at 12:55 p.m. ET.

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Additionally, Uptal Patel, Head of Biogen West Coast Hub, will participate in a fireside chat during the Piper Sandler 37th Annual Healthcare Conference. The webcast will be live on Wednesday, Dec 3, 2025, at 11:30 a.m. ET.

To access the live webcasts, please visit the Investors section of Biogen’s website at investors.biogen.com. An archived version of the webcasts will be available for at least 30 days following the presentation.

(Press release, Biogen, NOV 18, 2025, View Source [SID1234660061])

On November 18, 2025, in connection with its decision not to pursue further development of CLN-617, Cullinan Amber Corp. (the "Company"), a subsidiary of Cullinan Therapeutics, Inc. notified Massachusetts Institute of Technology ("MIT") of its decision to terminate the Exclusive Patent License Agreement, dated December 20, 2019 between the Company and MIT, as amended from time to time (the "License Agreement"), effective as of February 18, 2026. Pursuant to the License Agreement, MIT had granted the Company exclusive worldwide rights to the technology underlying CLN-617 to develop a cancer immunotherapy product worldwide. In connection with the termination of the License Agreement, the Company will return the licensed patent rights for the technology underlying CLN-617 to MIT.

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(Filing, 8-K, Cullinan Oncology, NOV 18, 2025, View Source [SID1234660861])

On November 18, 2025 Kazia Therapeutics Limited (Nasdaq: KZIA), an oncology-focused drug development company, reported that a patient with stage IV triple-negative breast cancer (TNBC) treated under an FDA-authorized single-patient expanded access protocol combining paxalisib with pembrolizumab (Keytruda) and standard chemotherapy has achieved an initial immune-complete response (iCR) per iRECIST criteria. This outcome suggests a profound radiologic response in a highly aggressive metastatic cancer subtype.

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This development builds upon Kazia’s October 2, 2025 announcement reporting an 86% reduction in tumor burden after only three weeks of treatment in the same patient. A PET/CT scan performed after approximately three months of therapy demonstrated complete metabolic resolution of all previously identified lesions, consistent with an initial iCR. The patient remains on therapy and under active clinical monitoring. A follow-up scan will be conducted in accordance with immune-based response assessment guidelines to confirm the initial scan.

Complete responses in stage IV metastatic TNBC are exceedingly uncommon across many therapeutic classes, including immunotherapy, chemotherapy, and antibody–drug conjugates. For example, pembrolizumab monotherapy has demonstrated complete response rates of approximately 0.6–4% in metastatic TNBC across KEYNOTE studies, and even the most active approved agents—such as sacituzumab govitecan—have reported complete response rates of only ~2–4% in large Phase 2 and Phase 3 trials.

In this setting, any radiologic finding consistent with an immune-complete response (iCR), even prior to confirmatory imaging, represents a highly unusual event which stands out relative to historical benchmarks for metastatic TNBC. These data may suggest enhanced biological activity of the combination regimen and warrant continued follow-up under iRECIST guidelines.

"Observing an initial complete response in a patient with metastatic triple-negative breast cancer is an extremely encouraging clinical finding," said Dr. John Friend, Chief Executive Officer of Kazia Therapeutics. "Although this is a single expanded-access case and requires confirmatory imaging, the depth of response aligns closely with our mechanistic hypothesis that paxalisib may meaningfully enhance anti-tumor immunity when combined with checkpoint blockade. This outcome further energizes our Phase 1b program in advanced breast cancer and complements significant progress across our broader pipeline."

Q4 BUSINESS UPDATE

1. Kazia Announces upcoming presentations related to paxalisib and NDL2 programs

Kazia is pleased to announce the acceptance of two scientific presentations at the 2025 Brisbane Cancer Conference, scheduled to take place on 27–28 November 2025 in Brisbane, Australia.

The Brisbane Cancer Conference is a premier oncology meeting that brings together leading international researchers, clinicians and industry experts working in the fields of translational oncology, molecular medicine and cellular therapeutics.

The following presentations will take on November 27, 2025:

"From bench to bedside: targeting epigenetic pathways to overcome metastasis and immunotherapy resistance in TNBC" – Sudha Rao, PhD, QIMR Berghofer (Australia)

Epigenetic checkpoint blockade: A new booster to enhance immunogenicity" Sherry Tu, PhD, QIMR Berghofer (Australia)

Kazia is proud to announce acceptance of two scientific presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS) to be held December 10–14, 2025. SABCS is the largest and most influential breast cancer meeting globally, drawing more than 10,000 international experts in clinical oncology, translational science, immunotherapy, and molecular diagnostics.

December 10, 2025 — PS2-10-02

"Liquid Biopsy Tracking of PI3K-mTOR Residual Disease Signatures in Metastatic Breast Cancer", Presenter: Prof. Sudha Rao, QIMR Berghofer (Australia)

December 12, 2025 — PS5-08-04

"A Phase 1b, Multi-Centre, Open-Label, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Activity of Combining Paxalisib with Olaparib or Pembrolizumab/Chemotherapy in Patients with Advanced Breast Cancer", Presenter: Dr. Michelle Nottage, The Royal Brisbane and Women’s Hospital (Australia)

"SABCS is the pinnacle global meeting for breast cancer research. Being selected for two presentations is both an honor and a strong validation of our scientific direction," stated Dr. Friend.

2. NDL2 PD-L1 Degrader Program: Advancing Toward IND-Enabling Studies anticipated in Early 2026

As announced in September 2025, Kazia entered into a collaboration and licensing agreement with QIMR Berghofer covering the first in class NDL2 PD-L1 degrader program. PD-L1 degraders represent the next frontier in immuno-oncology, using a dual-mechanism approach is designed to specifically recognize and degrade the resistant, post-translationally modified forms of the PD-L1 protein. This strategy may address resistance mechanisms that limit current checkpoint inhibitors. Kazia expects to initiate IND-enabling preclinical studies in early 2026.

3. GBM Program: Advancing Toward a FDA Type C Meeting Request Following Strong Overall Survival Signals

As detailed in the October 24, 2025 press release, Kazia intends to request a follow-up Type C meeting with the FDA to discuss the overall survival paxalisib findings from our completed clinical studies, alignment with the Project FrontRunner framework, potential requirements for a confirmatory study, and elements needed for a possible NDA submission pathway for paxalisib in newly diagnosed glioblastoma.

"We believe paxalisib’s OS data strongly justify continued engagement with the FDA and may support a more efficient regulatory strategy under Project FrontRunner," stated Dr. Friend.

4. As previously disclosed, Kazia received a notice (the "Notice") from the Listing Qualifications department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") on May 12, 2025 notifying the Company that from March 28, 2025 to May 9, 2025, the Company’s Market Value of Listed Securities ("MVLS") was below the minimum of $35 million required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2) (the "MVLS Requirement"). In accordance with Nasdaq Listing Rule 5810(c)(3)(C), Nasdaq provided the Company with 180 calendar days, or until November 10, 2025 to regain compliance with the MVLS Requirement.

On November 12, 2025, Kazia received a staff determination letter ("Staff Letter") from the Staff of Nasdaq indicating that the Company had not regained compliance with the MVLS Requirement by November 10, 2025. Pursuant to the Nasdaq Listing Rules and the Staff Letter, unless the Company timely requests a hearing before a Hearings Panel (the "Panel"), the Company’s American Depositary Shares would be subject to suspension/delisting . The Staff Letter has no immediate effect on listing or trading, and the Company intends to timely request a hearing before the Panel, which will automatically stay any suspension or delisting action pending the outcome of the hearing. The Company believes there are remedies available to potentially stop the proceedings and is evaluating corporate and market-based options, including alternative Nasdaq equity requirements to regain compliance.

(Press release, Kazia Therapeutics, NOV 18, 2025, View Source [SID1234660062])

On November 18, 2025 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported positive phase III results from the lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast cancer. The study met its primary endpoint at a pre-planned interim analysis, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival with giredestrant versus standard-of-care endocrine therapy. lidERA is the first phase III trial of a selective oestrogen receptor degrader (SERD) to demonstrate a significant benefit in the adjuvant setting. The majority of breast cancer cases are diagnosed at an early stage.

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"Today’s results underscore the potential of giredestrant as a new endocrine therapy of choice for people with early-stage breast cancer, where there is a chance for cure," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "Given that ER-positive breast cancer accounts for approximately 70% of cases diagnosed, these findings – together with recent data in the advanced ER-positive setting – suggest that giredestrant has the potential to improve outcomes for many people with this disease."

Overall survival data were immature at the time of interim analysis, but a clear positive trend was observed. Giredestrant was well tolerated and adverse events were consistent with its known safety profile, with no unexpected safety findings observed. Data from lidERA will be presented at an upcoming medical meeting and shared with health authorities with the aim of bringing this potential treatment option to patients around the world.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. Currently, up to a third of people eventually experience recurrence on or after adjuvant endocrine therapy treatment for early-stage breast cancer. Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death. These limitations underscore the need for more effective and better-tolerated options that can enhance adherence and prevent or delay disease recurrence.

lidERA is the second positive phase III readout for giredestrant following evERA Breast Cancer, which was presented at the European Society for Medical Oncology Congress 2025.1 The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels).9 This growing body of evidence supports the potential of giredestrant to meaningfully improve outcomes compared with standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer.1

Roche’s extensive giredestrant clinical development programme spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

About the lidERA Breast Cancer study
lidERA Breast Cancer [NCT04961996] is a phase III, randomised, open-label, multicentre study evaluating the efficacy and safety of adjuvant giredestrant versus standard-of-care endocrine therapy in people with medium- or high-risk stage I-III oestrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. Over 4,100 patients were enrolled in the study.10

The primary endpoint is invasive disease-free survival (iDFS) excluding unrelated cancers in other organs (second primary non-breast cancers).10 Key secondary endpoints include overall survival, iDFS including second primary non-breast cancers, disease-free survival and safety.10

About giredestrant
Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader and full antagonist.11

Giredestrant is designed to block oestrogen from binding to the oestrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.12

Giredestrant has an extensive clinical development programme and is being investigated in five company-sponsored phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
Giredestrant plus investigator’s choice of a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
Giredestrant plus Phesgo (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) versus Phesgo in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)
About oestrogen receptor (ER)-positive breast cancer
Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases.4 A defining feature of ER-positive breast cancer is that its tumour cells have receptors that attach to oestrogen, which can contribute to tumour growth.19

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity.20 Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy.20,21 There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

(Press release, Hoffmann-La Roche, NOV 18, 2025, View Source [SID1234660081])