On March 1, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, reported the non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor, Jaypirca (pirtobrutinib), has received approval by the National Medical Products Administration (NMPA) in China for a new indication for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least one line of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pirtobrutinib is a highly selective kinase inhibitor that utilizes a novel non-covalent binding mechanism to extend the benefit of targeting the BTK pathway in CLL/SLL patients previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib).[1],[2] Pirtobrutinib received approval from the U.S. FDA in January 2023 as a non‑covalent (reversible) BTK inhibitor. In October 2024, pirtobrutinib was approved in China as a monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two prior systemic therapies, including a Bruton’s tyrosine kinase (BTK) inhibitor.

The approval of this new indication is based on results from the international, multicenter, randomized, Phase 3 BRUIN CLL‑321 study. BRUIN CLL‑321 is the world’s first randomized Phase 3 trial conducted in patients with CLL/SLL who had previously been treated with a covalent BTK inhibitor (cBTKi). The study enrolled a total of 238 patients and evaluated the efficacy and safety of pirtobrutinib monotherapy versus investigator’s choice of IdelaR (idelalisib plus rituximab) or BR (bendamustine plus rituximab). The results demonstrated that pirtobrutinib significantly prolonged median progression‑free survival (PFS) compared with the investigator’s choice regimen (14.0 months vs 8.7 months; hazard ratio [HR] = 0.54). In addition, the discontinuation rate due to treatment‑related adverse events was lower with pirtobrutinib (5.2% vs 21.1%), further supporting its efficacy and tolerability advantages in patients previously treated with a covalent BTK inhibitor.[3]

Professor Lu-Gui Qiu, Principal Investigator of the BRUIN CLL‑321 study in China, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, stated, "BTK inhibitors have become the preferred first‑ or second‑line treatment for patients with CLL/SLL, yet some patients still experience disease progression and have a poor prognosis. Studies have shown that the median overall survival for patients after discontinuing a covalent BTK inhibitor is only about 22.7 months.[4] Therefore, there is an urgent clinical need for new treatment. As a next‑generation, non‑covalent and reversible BTK inhibitor, pirtobrutinib represents an important advancement for patients with relapsed or refractory CLL. The BRUIN CLL‑321 study demonstrated its therapeutic potential in CLL/SLL. We believe it will offer an important treatment option for patients with CLL/SLL in China and help meet the needs of long‑term disease management in the future."

Dr. Li Wang, Lilly Corporate Senior Vice President, Head of Lilly China Drug Development & Medical Affairs Center, states, "The approval of pirtobrutinib for the CLL/SLL indication in China marks an important milestone in the treatment journey for Chinese CLL/SLL patients. It means that patients who continue to experience disease progression after covalent BTK inhibitor therapy can now gain timely access to this globally innovative treatment option. Supported by the efficacy and safety demonstrated in the BRUIN CLL‑321 study, we are pleased to offer a new therapeutic choice for CLL/SLL patient population with significant unmet medical needs in China. Looking ahead, Lilly will remain committed to accelerating the introduction of cutting‑edge therapies to help patients with hematologic malignancies in China achieve longer and better quality of survival. This is our enduring commitment to patients in China."

Dr. Hui Zhou, Chief R&D Officer of Oncology in Innovent, stated, "Jaypirca (pirtobrutinib) is a next-generation, non-covalent (reversible) BTK inhibitor. It offers a novel treatment option for patients who have previously received covalent BTK inhibitor therapy. The approval in China for CLL/SLL represents a significant breakthrough in this field, which ensures that CLL/SLL patients in China have timely access to this global therapeutic innovation. We will fully leverage Innovent’s leading brand presence and commercialization capabilities in oncology, to accelerate the accessibility of this innovative therapy, thereby benefiting more cancer patients in need."

About BRUIN CLL-321
BRUIN CLL-321 is a Phase 3, randomized, open-label study of Jaypirca versus investigator’s choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in covalent Bruton tyrosine kinase (BTK) inhibitor pre-treated patients with relapsed and refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial enrolled 238 patients, who were randomized 1:1 to receive Jaypirca (200 mg orally, once daily) or investigator’s choice of either IdelaR or BR per labeled doses. This trial’s primary endpoint is progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, as assessed by blinded independent review committee (IRC). Secondary endpoints include PFS, as assessed by investigator; overall response rate (ORR) and duration of response (DoR); event-free survival; overall survival (OS) and time to next treatment (TTNT); safety and tolerability; and patient-reported outcomes (PRO).

About Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.[2] BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).[5],[6]

In China, pirtobrutinib was developed by Eli Lilly and Company and is commercialized in mainland China by Innovent Biologics.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of slow-growing non-Hodgkin lymphoma that develop from white blood cells known as lymphocytes.[7] In China, chronic lymphocytic leukemia (CLL) represents approximately 6%–7% of non-Hodgkin lymphoma cases.[8] SLL is identical to CLL from a pathologic and immunophenotypic standpoint, with the main difference between them being the location of the cancer cells. In CLL, the cancer cells are present in the blood, and in SLL, the cancer cells are found in the lymph nodes.

(Press release, Innovent Biologics, MAR 1, 2026, View Source [SID1234663146])

On February 28, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the presentation of results from the pivotal Phase 3 LITESPARK-022 trial evaluating KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, for patients with clear cell renal cell carcinoma (RCC) following nephrectomy. These late-breaking data will be presented for the first time today during an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (abstract #LBA418) and are included in the official ASCO (Free ASCO Whitepaper) GU Press Program.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At the first pre-specified interim analysis (median follow-up of 28.4 months [range, 15.0-40.1 months]), KEYTRUDA plus WELIREG given in the adjuvant setting significantly improved disease-free survival (DFS), the study’s primary endpoint, reducing the risk of disease recurrence or death by 28% (HR=0.72 [95% CI 0.59-0.87]; p=0.0003) compared to KEYTRUDA plus placebo. Median DFS was not reached in either arm; the estimated 24-month DFS rate was 80.7% (95% CI, 77.7-83.2) for the KEYTRUDA plus WELIREG arm and was 73.7% (95% CI, 70.6-76.6) for the KEYTRUDA plus placebo arm. As previously reported, the trial will continue to evaluate overall survival (OS), a key secondary endpoint.

"Approximately 40% of patients with renal cell cancer may experience tumor growth after initial treatment. Results from LITESPARK-022 mark an important step forward for certain patients with renal cell cancer, showing a significant reduction in the risk of disease recurrence or death compared to pembrolizumab alone," said Dr. Toni K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg professor of medicine, Harvard Medical School. "The combination of pembrolizumab and belzutifan is the first ever regimen in the adjuvant setting for renal cell cancer to demonstrate an improvement in disease-free survival over pembrolizumab monotherapy, positioning this regimen to potentially reshape clinical practice."

"LITESPARK-022 is a critical part of our comprehensive RCC clinical development program, and the Phase 3 results presented at ASCO (Free ASCO Whitepaper) GU underscore the importance of KEYTRUDA and WELIREG in helping to treat patients with certain types of renal cell carcinoma," said Dr. M. Catherine Pietanza, vice president, Global Clinical Development, Merck Research Laboratories. "These findings represent the first positive Phase 3 data for WELIREG in earlier stages of disease, as well as the first positive Phase 3 results for a HIF‑2α inhibitor and immunotherapy combination, reinforcing our commitment to exploring novel treatment approaches to improve upon established treatment paradigms for patients in need."

The safety profile of KEYTRUDA plus WELIREG was consistent with that observed in previously reported studies for both agents; no new safety signals were observed. Of patients enrolled, 69.5% of those in the KEYTRUDA plus WELIREG arm and 71.1% of those in the KEYTRUDA plus placebo arm completed the assigned treatment. Among treated patients, Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 52.1% of patients who received KEYTRUDA plus WELIREG and 30.2% of patients who received KEYTRUDA plus placebo. The most common Grade ≥3 TEAEs were anemia (12.1% versus 0.5%), increased alanine aminotransferase (ALT) (6.4% versus 2.0%) and hypoxia (4.6% versus 0%). Grade 5 treatment-emergent (1.1% versus 1.2%) and treatment-related adverse events (0.3% versus 0.3%) were similar between treatment arms.

Based on data from the LITESPARK-022 trial, the U.S. Food and Drug Administration (FDA) has accepted for priority review supplemental applications seeking approval of WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) for the adjuvant treatment of adult patients with RCC with a clear cell component with increased risk of recurrence following nephrectomy. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of June 19, 2026 for the WELIREG sNDA and the KEYTRUDA and KEYTRUDA QLEX sBLAs. Merck will also discuss these data with global regulatory authorities.

KEYTRUDA is approved for the adjuvant treatment of certain patients with RCC in the U.S., Canada, European Union (EU), Japan and other countries worldwide based on data from KEYNOTE-564.

WELIREG is approved in over 45 countries including the U.S., Canada, EU, and Japan for the treatment of adult patients with advanced RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.

Merck has an industry-leading clinical development program in RCC, leveraging multiple approved therapeutic options across multiple settings, including adjuvant and advanced disease.

About LITESPARK-022

LITESPARK-022 is a multicenter, randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05239728) evaluating WELIREG in combination with KEYTRUDA compared to KEYTRUDA plus placebo for the treatment of patients with clear cell RCC following nephrectomy. The primary endpoint is DFS, and key secondary endpoints include OS, safety and quality of life outcomes. The trial enrolled 1,841 patients who were randomized to receive either:

WELIREG (120 mg orally once daily for approximately one year) plus KEYTRUDA (400 mg intravenously every six weeks for approximately one year), or;
KEYTRUDA plus placebo.
About renal cell carcinoma

Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer diagnosed and approximately 156,000 deaths from the disease worldwide. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage.

(Press release, Merck & Co, FEB 28, 2026, View Source [SID1234663144])

On February 28, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai reported the first presentation of results from the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-programmed death receptor-1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy. These data are being presented as a late-breaking oral abstract at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (abstract #LBA417) and are included in the official ASCO (Free ASCO Whitepaper) GU Press Program.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At a pre-specified interim analysis with a median follow-up of 29.0 months (range, 19.3-49.2), WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS), reducing the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.59-0.84]; p=0.00007) compared to cabozantinib. For WELIREG plus LENVIMA, the median PFS was 14.8 months (95% CI, 11.2-16.6) versus 10.7 months (95% CI, 9.2-11.1) for cabozantinib. A trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was also observed for WELIREG plus LENVIMA (HR=0.85 [95% CI, 0.68-1.05]; p=0.06075). The median OS was 34.9 months (95% CI, 27.5-NR) for WELIREG plus LENVIMA versus 27.6 months (95% CI, 24.0-31.4) for cabozantinib. The trial is continuing, and OS will be evaluated at a subsequent analysis per the clinical trial protocol.

Based on data from the LITESPARK-011 trial, the U.S. Food and Drug Administration (FDA) has accepted two supplemental New Drug Applications (sNDA) for review seeking approval for WELIREG plus LENVIMA for the treatment of adult patients with advanced RCC with a clear cell component following a PD-1 or PD-L1 inhibitor. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of October 4, 2026 for both the WELIREG and LENVIMA sNDAs. Merck and Eisai will also discuss these data with regulatory authorities worldwide to support potential submissions outside the United States.

"Choosing the right treatment for patients with advanced renal cell carcinoma after immunotherapy has been an ongoing challenge, and treatment options in this setting had not previously been evaluated against a current standard of care tyrosine kinase inhibitor in a Phase 3 trial," said Dr. Robert Motzer, Principal Investigator and Genitourinary Medical Oncologist, Memorial Sloan Kettering Cancer Center. "The LITESPARK-011 study demonstrated a 30% reduction in the risk of disease progression or death with belzutifan plus lenvatinib compared to cabozantinib, and 52.6% of patients experienced a response to treatment. These findings mark a critical step forward for these patients."

"The LITESPARK-011 trial highlights the potential of this first-of-its-kind combination regimen to deliver a meaningful benefit for patients with advanced renal cell carcinoma whose disease progresses after PD-1/L1 therapy," said Dr. M. Catherine Pietanza, Vice President, Global Clinical Development, Merck Research Laboratories. "These WELIREG plus LENVIMA data demonstrate important progress for patients with advanced renal cell carcinoma and reinforce our commitment to improving the lives of patients through innovative treatment strategies."

"The LITESPARK-011 results reinforce LENVIMA’s established role in renal cell carcinoma and highlight the potential of this novel combination to address an area of significant unmet need," said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai. "The acceptance of this regulatory filing is an important milestone, and we remain committed to working toward approval to bring this option to patients as soon as possible. We are grateful to the patients, their families, and the investigators, whose dedication made this research possible."

Additional findings

Data for objective response rate (ORR) and duration of response (DOR), two key secondary endpoints, were also reported. At the first interim analysis with a median follow-up of 19.6 months (range, 9.9-39.8), WELIREG plus LENVIMA met ORR, demonstrating a statistically significant improvement compared to cabozantinib. A confirmed ORR of 52.6% (95% CI, 47.3-57.7) was observed for WELIREG plus LENVIMA versus 39.6% (95% CI, 34.6-44.8) for cabozantinib. At the second interim analysis with a median follow-up of 29.0 months, the median DOR was 23.0 months (95% CI, 2.0-44.3+) for WELIREG plus LENVIMA versus 12.3 months (95% CI, 1.8+-35.9+) for cabozantinib.

WELIREG plus LENVIMA was administered to 370 patients and cabozantinib was administered to 371 patients. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 71.6% of patients receiving WELIREG plus LENVIMA versus 65.8% of patients receiving cabozantinib. Adverse events led to the discontinuation of 11.1% of patients receiving WELIREG plus LENVIMA versus 11.3% of patients receiving cabozantinib, respectively. Serious adverse events were observed in 51.6% of patients receiving WELIREG plus LENVIMA versus 43.9% of patients receiving cabozantinib, and AEs led to death in 5.4% of patients (two were treatment-related: thrombotic microangiopathy [n=1] and pneumonitis [n=1]) versus 3.2% (one was treatment-related: hemoptysis [n=1]) of patients, respectively.

LITESPARK-011 is part of a comprehensive late-stage clinical development program for WELIREG comprised of several Phase 2 and Phase 3 trials in pheochromocytoma and paraganglioma, von Hippel-Lindau disease-associated neoplasms and RCC.

The Phase 3 LITESPARK-012 trial is evaluating the addition of WELIREG to KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA in the first-line advanced RCC disease setting.

WELIREG is approved in the U.S., European Union (EU), Japan and other countries for the treatment of adult patients with advanced clear cell RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.

KEYTRUDA plus LENVIMA is approved in the U.S., the EU, Japan and other countries for the treatment of advanced RCC. Lenvatinib is approved as KISPLYX for advanced RCC in the EU.

LENVIMA in combination with everolimus is approved in the U.S., EU and other regions for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy.

Dr. Motzer has provided consulting and advisory services for Merck and Eisai.

About LITESPARK-011

LITESPARK-011 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT04586231) evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced clear cell RCC that has progressed on or after anti-PD-1/L1 therapy. The dual primary endpoints are PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by blinded independent central review (BICR) and OS. Key secondary endpoints include ORR per RECIST v1.1 as assessed by BICR, DOR per RECIST v1.1 as assessed by BICR, and safety. The trial enrolled 747 patients who were randomized to receive WELIREG (120 mg orally once daily) plus LENVIMA (20 mg orally once daily) or cabozantinib (60 mg orally once daily).

About renal cell carcinoma

Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer and approximately 156,000 deaths from the disease worldwide. RCC is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage.

(Press release, Merck & Co, FEB 28, 2026, View Source [SID1234663143])

On February 27, 2026, the U.S. Food and Drug Administration ("FDA") reported a Complete Response Letter ("CRL") for the supplemental Biologics License Application ("sBLA") for Zynyz (retifanlimab-dlwr) injection (375mg) for an additional indication for the treatment of adult patients with metastatic non-small cell lung cancer ("NSCLC") in combination with platinum-based chemotherapy. The sBLA was supported by positive efficacy and safety data from the Phase 3 POD1UM-304 trial announced in December 2024.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The CRL cited inspection findings (not specific to Zynyz) at Catalent Indiana, LLC ("Catalent Indiana"), part of Novo Nordisk, the third-party fill-finish facility referenced in the sBLA. The CRL cited the regulatory compliance of Catalent Indiana as the sole approvability issue, and did not cite other approvability concerns, including Zynyz’s efficacy and safety data in NSCLC or the third-party drug substance manufacturer.

Incyte Corporation is working closely with the FDA and Catalent Indiana to address the CRL and support a potential sBLA resubmission of Zynyz in NSCLC.

(Press release, Incyte, FEB 27, 2026, View Source [SID1234663336])

On February 27, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a publicly traded biotechnology and precision intracellular drug-delivery company, reported the launch of a private placement (the "Private Placement") of up to 20,000,000 units (the "Units") at a price of $0.55 per Unit, for aggregate gross proceeds to Defence of up to $11,000,000. Each Unit will be comprised of one common share (each, a "Share") and one common share purchase warrant ("Warrants"). Each Warrant will entitle its holder to acquire an additional common share of the Company at a price of $0.65 per share for 24 months following the date of issuance.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company has executed a binding term sheet with two arm’s length institutional investors (collectively, the "Investors") in connection with the Private Placement for aggregate gross proceeds of $6,000,000 (CAD) (the "Investors’ Proceeds"). In connection with the Private Placement, the Investors’ Proceeds and the Units will be deposited in escrow in advance of closing pursuant to an escrow agreement (the "Escrow Agreement"). Upon closing, the Units will be released from escrow and delivered to the Investors or as they may direct, and the Investors’ Proceeds will be released from escrow and deposited as credit support pursuant to an ISDA Credit Support Annex, and released to the Company in monthly cash tranches of $333,333 (CAD) over an 18-month period (the "Term"), pursuant to the terms and conditions of a sharing agreement (the "Sharing Agreement") to be dated and executed on the closing of the Private Placement. Settlements under the Sharing Agreement shall commence five months after closing.

Pursuant to the Sharing Agreement, Shares will be released in equal monthly installments of approximately 606,060 Shares over the 18-month Term, with each release contingent upon the corresponding cash payment being delivered to the Company. The Sharing Agreement shall provide that the Company’s economic interest will be determined in 18 monthly settlement tranches as measured against a benchmark price of $0.7332 (CAD) per Share (the "Benchmark Price"). If, at the time of settlement, the settlement price (determined monthly based on a 20-day volume-weighted average trading price of the Company’s shares on the CSE) exceeds the Benchmark Price, the Company shall receive more than 100% of the monthly settlement due, on a pro rata basis, with no upper limit on additional proceeds. If the settlement price is below the Benchmark Price, the Company will receive less than 100% of the monthly settlement due, on a pro rata basis. In no event will a decline in the settlement price result in an increase in the number of Shares being issued to the Investors. As a result, the Company may ultimately receive more or materially less than the original proceeds of $6,000,000. The final amount received will depend on the Company’s future share price, which is subject to market fluctuations and may vary over time. Accordingly, there is no assurance as to the total amount the Company will receive under the Sharing Agreement.

All 10,909,091 Warrants to be issued shall be exercisable at an exercise price of $0.65 (CAD) per Share for a period of 24 months following the date of issuance. The Warrants will include an equity blocker provision that prohibits the holder from exercising any portion of the Warrants if such exercise would result in the holder owning more than 9.99% of the Company’s outstanding Shares.

The Investors will receive a corporate finance fee of $360,000 (CAD) in connection with the Sharing Agreement, payable in cash or via the issuance of 654,546 Units at the Private Placement price, at the election of the Company (the "Fee").

The Company has agreed to pay a non-refundable deposit of $65,000 (CAD)
(the "Deposit") upon receipt of approval from the CSE in connection with the Private Placement. The Deposit shall be satisfied by the issuance of 118,182 Units at the Private Placement price.

Defence intends to use the proceeds from the Private Placement to advance its Antibody Drug Conjugate ("ADC") and Radiopharmaceutical programs, to develop partnerships and for working capital purposes. The Company may pay a finder’s fee in connection with the offering to eligible arm’s-length finders in accordance with the policies of the Canadian Securities Exchanges.

Pursuant to applicable Canadian securities laws and in accordance with the Exchange policies, all securities issued under this Private Placement will be subject to applicable resale restrictions under applicable securities laws. The closing of the Private Placement is expected on or about March 6, 2026, subject to the approval of the CSE.

The Units described herein have not been, and will not be, registered under the U.S. Securities Act or any state securities laws, and accordingly, may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions there from. This press release does not constitute an offer to sell or a solicitation to buy any securities in any jurisdiction.

(Press release, Defence Therapeutics, FEB 27, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-announces-private-placement-of-units-for-proceeds-of-up-to-11-million [SID1234663221])