On September 29, 2026 Convert Pharmaceuticals reported it has shared the first clinical results for CP-506, its lead drug candidate. The data come from the ongoing Phase I TUMAGNOSTIC trial (NCT04954599). They show that CP-506 is well tolerated and can shrink tumours in patients who had no treatment options left.

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CP-506 is a hypoxia-activated prodrug. It stays inactive as it travels through the body. It only switches on in the low-oxygen (hypoxic) regions of a tumour. These regions hold some of the most aggressive and treatment-resistant cancer cells.

Key results so far

Safety: no dose-limiting toxicity across the first four dose levels.
Mechanism confirmed in humans: the active form of the drug circulates at about 1/70th of the prodrug level. This supports activation inside the tumour rather than in healthy tissue.
Longer exposure: an elimination half-life of 5.6 hours, substantially longer than earlier hypoxia-activated prodrugs.
Early signs of benefit: patients with pancreatic, head and neck, and breast cancer reached stable disease. Exploratory volume measurements showed tumour reductions of 49% and 25% (pancreatic, dose level 4), 37% (head and neck) and 11% (breast, dose level 3).
All patients in the trial had already exhausted the available treatments.

A new way to reach the tumour core

"For decades, cancer treatment has faced a difficult trade-off: exposing the whole body to a drug while trying to kill cancer cells deep inside a tumour. CP-506 is designed to change that equation," said Prof. Dr. Philippe Lambin, Founder and CEO of Convert Pharmaceuticals.

The results also drew attention from outside the company. "Hypoxia has resisted every attempt to drug it for decades. Convert appears to have solved that," said Dr. Antonin de Fougerolles, founding Chief Scientific Officer of Moderna and former CSO of Ablynx Therapeutics.

The road ahead

Dose escalation continues. The remaining dose levels are expected to roughly double exposure to CP-506.
The protocol includes Phase IIa arms that combine CP-506 with carboplatin and with checkpoint inhibitors.
Convert will keep reporting progress as the trial advances.
These results build on the milestones shared in our June 2026 update on TUMAGNOSTIC.

(Press release, Convert Pharmaceuticals, SEP 29, 2026, View Source [SID1234671144])

On September 29, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519, hereafter "Chugai") and InxMed (Hong Kong) Limited (hereafter "InxMed") reported that they have entered into a worldwide license agreement regarding SPYK04, a RAF-MEK molecular glue discovered by Chugai for the treatment of solid tumors.

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Under the terms of the agreement, Chugai will grant InxMed an exclusive worldwide license to develop, manufacture, and commercialize SPYK04 for all indications. In return, Chugai will receive an upfront payment as well as royalties based on sales following product launch. In addition, in the event that InxMed receives income other than royalties from sublicensees, Chugai will be entitled to receive a certain portion of the income.

SPYK04 is a small-molecule compound discovered by Chugai for the treatment of solid tumors. Acting as a "molecular glue" that binds RAF and MEK, proteins involved in cancer cell proliferation, SPYK04 induces the formation of an inactive RAF-MEK complex, thereby inhibiting proliferative signaling in cancer cells, and is expected to exert antitumor effects.

Chugai’s President and CEO, Dr. Osamu Okuda, commented, "We are pleased to have entered into a license agreement for SPYK04 with InxMed, which has strong expertise in the oncology field. We expect that InxMed will steadily advance development leveraging the unique characteristics of SPYK04, and we hope that it will be delivered as a cancer treatment to patients around the world as soon as possible."

Dr. Zaiqi Wang, Founder, Chairman and CEO of InxMed, commented, "We are thrilled to enter into this licensing agreement with Chugai for asset SPYK04. This collaboration marks a significant milestone in our mission to deliver further precision oncology therapies. We look forward to rapidly advancing this asset to bring more effective, durable treatment options to cancer patients worldwide."

(Press release, Chugai, SEP 29, 2026, View Source [SID1234671143])

On September 29, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that a subset analysis of data from the company’s Phase 2 CLOVER WaM clinical trial that support the potential of iopofosine I 131 as a potential treatment option for Waldenström Macroglobulinemia (WM) patients who are refractory or resistant to BTK inhibitor therapy will be highlighted in a presentation at the upcoming International Workshop for Waldenström Macroglobulinemia (IWWM) taking place October 14 – 16, 2026 in Palm Springs, California.

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"We are pleased to present these data from the CLOVER-WaM study at IWWM and share additional evidence supporting the potential of iopofosine I 131 to address a significant unmet need for patients with WM. This analysis evaluated patients who received iopofosine I 131 immediately following BTK inhibitor therapy after at least two prior lines of treatment, representing a particularly challenging, heavily pretreated population," said Jarrod Longcor, chief operating officer at Cellectar Biosciences. "We remain on-target to dose patients in the confirmatory Phase 3 clinical trial in early 2027 and to file our New Drug Application for accelerated approval in the first half of 2027. Given iopofosine I 131 has Breakthrough Therapy Designation, we expect a six-month review with a potential approval by the end of 2027."

Details of the upcoming poster presentation are as follows:

Title: "Iopofosine I 131 After BTK Inhibitors in Waldenström Macroglobulinemia: CLOVER-WaM Subgroup Efficacy and Safety"
Session #: 14
Date/Time: October 15, 2026, 4:00 PM
Location: Sierra-Ventura Hall
Presenter: Jarrod Longcor, Chief Operating Officer of Cellectar Biosciences

(Press release, Cellectar Biosciences, SEP 29, 2026, https://www.cellectar.com/investors/news-events/press-releases/detail/397/cellectar-biosciences-to-present-compelling-efficacy-data-from-phase-2-clover-wam-subset-analysis-of-iopofosine-i-131-in-patients-refractoryresistant-to-btk-inhibitor-therapy-at-international-workshop-for-waldenstrm-macroglobulinemia [SID1234671142])

On September 29, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing innovative therapies for the treatment of cancer and other diseases, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to Plinabulin and docetaxel for the treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer ("NSCLC") without actionable genomic alterations (AGAs) whose disease has progressed following prior anti-PD-(L)1 antibody therapy and platinum-based chemotherapy, representing patients in the second- or third-line treatment setting. This is the patient population being studied in BeyondSpring’s global Phase 3 DUBLIN-4 trial.

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Plinabulin, a first-in-class small molecule agent, has an extensive clinical safety database with more than 700 cancer patients. Its differentiated immuno-modulating mechanism and previously reported encouraging clinical data from DUBLIN-3 and Study 303 support the trial design of DUBLIN-4 in Plinabulin mechanism-targeted post-ICI non-squamous NSCLC patients.

The Company also announced a strategic transaction with Biolin Investment Limited ("Biolin") relating to the China portion of DUBLIN-4. Under the arrangement, the Company will sell its majority equity interest in its Chinese subsidiary, and Biolin will support DUBLIN-4 clinical development activities in China, which activities are expected to include enrollment of approximately 221 patients. BeyondSpring expects the transaction to substantially reduce its cash requirements for DUBLIN-4 while supporting efficient enrollment and the generation of China clinical data for the global trial.

"We believe the FDA Fast Track designation, an FDA-aligned global Phase 3 strategy, and funding to support China-generated clinical data would meaningfully strengthen our ability to advance Plinabulin and DUBLIN-4 toward the trial’s next major clinical milestone—the prespecified interim analysis at 221 PFS events," said Min Qiu, CEO of BeyondSpring. "Fast Track designation underscores the significant unmet medical need for the DUBLIN-4 patient population in NSCLC patients whose disease has progressed following ICI and without AGAs, with limited options and docetaxel as the standard of care. Importantly, the strategic transaction provides a time- and capital-efficient approach to executing our global Phase 3 clinical strategy. Positive results from the interim analysis could represent a meaningful value inflection point for BeyondSpring."

FDA Fast Track Designation

FDA Fast Track designation is designed to facilitate development and expedite review of therapies intended to treat serious conditions with unmet medical needs. The designation provides opportunities for more frequent interactions with the FDA regarding the development program and may allow for rolling review of a future regulatory application. Plinabulin may also be eligible for Priority Review if applicable criteria are met.

DUBLIN-4: Global Registrational Phase 3 Strategy

DUBLIN-4 is a randomized global Phase 3 trial evaluating Plinabulin plus docetaxel versus docetaxel alone in patients with advanced non-squamous NSCLC without actionable genomic alterations following progression on ICI and chemotherapy.

Approximately 442 patients are planned to be randomized 1:1, with overall survival ("OS") as the primary endpoint and PFS and objective response rate ("ORR") as secondary endpoints. The trial includes a prespecified interim analysis at 221 PFS events.

Approximately half of the planned trial population is expected to be enrolled at participating sites in China under the strategic arrangement, with the remainder expected to be enrolled through the broader global DUBLIN-4 program, including in the United States and other regions. BeyondSpring intends for data generated across participating regions to form part of an integrated global clinical dataset supporting its registration strategy for Plinabulin.

Strategic Arrangement Supports Global Phase 3 Execution

BeyondSpring has entered into a definitive agreement with Dalian Wanchunbulin Pharmaceuticals Ltd., the Company’s Chinese subsidiary ("Bulin"), and Biolin, pursuant to which BeyondSpring will sell BeyondSpring Ltd., its wholly owned subsidiary that indirectly holds the majority equity interest in Bulin, to Biolin.

Under the arrangement, Biolin will support the funding of clinical development activities conducted by Bulin at participating sites in China, and BeyondSpring will receive access to clinical data generated from the China portion of DUBLIN-4. Patients enrolled in China are expected to represent approximately half of the planned 442-patient global enrollment. Biolin’s obligation to support the funding of the China portion of DUBLIN-4, and to cause Bulin to conduct and use commercially reasonable efforts to complete the trial and perform certain related activities, will constitute the non-cash consideration for the sale of BeyondSpring Ltd.

Following the transaction, BeyondSpring will retain global rights to Plinabulin outside Greater China. The arrangement is expected to substantially reduce BeyondSpring’s cash requirements associated with DUBLIN-4, while China’s large eligible NSCLC patient population is expected to support efficient enrollment.

Conference Call and Webcast Information

BeyondSpring’s management will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss the announcement. The dial-in numbers are 1-877-737-7051 (U.S.) or 1-201-689-8878 (international). The live webcast will be available here. An archived replay of the webcast will be available following the presentation on BeyondSpring’s website www.beyondspringpharma.com under "Events" in the Investor section.

About Plinabulin and the Clinical Rationale for DUBLIN-4 Trial

Plinabulin is a late-stage, first-in-class investigational GEF-H1 agonist with a differentiated mechanism of action that includes dendritic cell maturation, anti-angiogenic activity and mitigation of chemotherapy-induced neutropenia. To date, more than 700 cancer patients have been treated with Plinabulin across multiple clinical programs in various cancer types, demonstrating an extensive clinical safety database.

The post-ICI setting remains difficult to treat, with 12 Phase 3 trials evaluating different treatment approaches against docetaxel, including four involving ADCs, having failed to demonstrate an overall survival benefit over docetaxel.

In the Phase 3 DUBLIN-3 Trial, published in The Lancet Respiratory Medicine in 2024, Plinabulin combined with docetaxel demonstrated a statistically significant improvement in OS in second- and third-line EGFR wild-type NSCLC vs. docetaxel alone (n=559), showing superior OS benefit in non-squamous patients (n=332, OS HR 0.72, p=0.0078). The combination also demonstrated statistically significant improvements compared to docetaxel alone, including doubling 2-year and 3-year survival rates and improvements in PFS and ORR, while also significantly reducing grade 4 neutropenia (p<0.0001).

Importantly, a post hoc analysis of the DUBLIN-3 post-ICI subgroup showed a median OS of 15.8 months with Plinabulin plus docetaxel versus 11.7 months with docetaxel alone (HR 0.55), with ORR of 18.2% versus 8.0%, respectively. These findings support the clinical rationale for Plinabulin’s differentiated dendritic cell maturation mechanism and its further evaluation in DUBLIN-4.

This rationale was further supported by prospective data from the Phase 2 Study 303 (n=47), presented at ASCO (Free ASCO Whitepaper) 2026. In patients with NSCLC whose disease had progressed following PD-1 inhibitor treatment, the combination of Plinabulin, docetaxel and a PD-1 inhibitor demonstrated encouraging anticancer activity. With a median follow-up of 28.8 months, the Plinabulin combination showed a median PFS of 7.0 months, a disease control rate of 79.5%, and a confirmed ORR of 18.2%, with a 2-year OS rate of 58%, nearly double the historical rate reported with docetaxel in a similar patient population.

(Press release, BeyondSpring Pharmaceuticals, SEP 29, 2026, View Source [SID1234671141])

On September 29, 2026 Alligator Bioscience AB ("Alligator Bioscience" or the "Company"), reported, based on the authorization granted by the extraordinary general meeting on 26 August 2026, resolved on a directed issue of 187,795,097 warrants series 2026/2031 to Fenja Capital II A/S ("Fenja Capital"). The issue constitutes part of the renegotiation of the outstanding loan from Fenja Capital which was raised in June 2024 and that the parties agreed on in connection with the rights issue of units resolved upon by the board of directors on 23 July 2026 (the "Rights Issue"). The Company can also announce that none of the guarantors who have entered into guarantee commitments in the Rights Issue have chosen to receive guarantee compensation in the form of newly issued units, which means that guarantee compensation will be paid in a cash amount of approximately SEK 7.7 million.

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Directed issue of warrants
In accordance with the Company’s press release from 23 July 2026, the Company has, in connection with the Rights Issue, renegotiated the outstanding loan (the "Loan") from Fenja Capital, which was originally raised in June 2024. As part of the renegotiation, the Company has undertaken to issue warrants series 2026/2031 to Fenja Capital, free of charge. The Board of Directors has therefore today, based on the authorization granted by the extraordinary general meeting on 26 August 2026, resolved on a directed issue of 187,795,097 warrants series 2026/2031 to Fenja Capital. The number of warrants series 2026/2031 that are issued corresponds to a total dilution of five percent calculated on the total number of ordinary shares outstanding in the Company immediately after the completion of the Rights Issue and the Compensation Issue. The warrants will not be admitted to trading. The warrants series 2025/2030 that were issued to Fenja Capital in connection with the Company’s previous rights issue in 2025 will be cancelled.

The warrants are issued free of charge and enable further capital contributions to the Company from and including the registration of the new warrants with the Swedish Companies Registration Office up to and including 31 October 2031. In the event all warrants series 2026/2031 issued to Fenja Capital are fully exercised for subscription of new ordinary shares, 187,795,097 new ordinary shares will be issued. The exercise price for the warrants shall correspond to SEK 0.028 per share. Upon full exercise of all warrants series 2026/2031 issued to Fenja Capital, the Company may receive an additional capital injection of up to approximately SEK 5 million, before issue costs. The warrants are subject to terms and conditions that contain recalculation terms that entail a so-called "full dilution protection", meaning that Fenja Capital, with certain exceptions, shall be compensated in the event of certain corporate actions so that Fenja Capital always has the right to be allocated additional warrants so that the warrants held by Fenja Capital together entail the same dilution as the warrants represented immediately prior to the corporate action, calculated on the number of outstanding ordinary shares in the Company. Examples of such corporate actions are bonus issue, reverse share split, new issue of shares, rights issue, directed issue and resolution on reduction of the share capital. In such an event, the exercise price for such additional warrants shall be adjusted to the lower of (a) 140 percent of the subscription price in the relevant corporate action and (b) any recalculated exercise price determined in accordance with the terms and conditions of the warrants. Furthermore, the exercise price for the warrants outstanding prior to the corporate action shall, at Fenja Capital’s request, also be subject to the same adjustment. Fenja Capital’s rights regarding additional warrants shall continue to apply even after the Loan has been repaid or the loan agreement has expired, and shall only expire when the warrants expire on 31 October 2031.

The reasons for the deviation from the shareholders’ preferential rights are that the issue constitutes an integral and crucial part of the restructuring of the Loan. The Board of Directors has carefully considered various financing solutions as alternatives to the restructuring of the Loan. In connection with the planning for a capital raise to secure the Company’s future working capital needs, a dialogue was initiated with Fenja Capital regarding restructuring of the original financing to extend the Loan. In connection with the negotiations, the Board of Directors considered inter alia the possibility of financing the business by raising additional separate loans but made the assessment that such loans would likely not be entered into on terms favorable to the Company or in due time, considering the prevailing market conditions. The Board of Directors also considered the possibility of increasing the size of the Rights Issue, to repay the Loan in its entirety, but made the assessment that such a rights issue would probably not be fully subscribed or subscribed to a sufficient extent. In an overall assessment of the possibility of financing the business, the Board of Directors’ assessment is thus that the reasons for the renegotiation of the Loan, which includes a directed issue of warrants, outweigh the reasons that justify the main rule that new issues shall be carried out with preferential rights for the shareholders and the issue of warrants is, in the opinion of the Board of Directors, thus the most advantageous alternative for the Company and the Company’s shareholders. In addition, the Board of Directors believes that it is advantageous that the issue of the warrants can result in the Company receiving a potential additional capital injection upon exercise of the warrants.

Shares, share capital and dilution
In the event all outstanding warrants series 2026/2031 issued to Fenja Capital are exercised in full for subscription of new ordinary shares, the total number of shares in the Company will increase by 187,795,097 shares, from 3 568,106,848 shares to 3,755,901,945 shares (based on the number of shares after the Rights Issue), whereof all outstanding shares are ordinary shares. The share capital will increase by SEK 938,975.485, from SEK 17,840,534.24 to SEK 18,779,509.725. This corresponds to a dilution effect of 5 percent of the total number of ordinary shares in the Company after the Rights Issue and full exercise of all warrants series 2026/2031 issued to Fenja Capital.

Advisers
APREA Partners AB acts as financial adviser in connection with the Rights Issue. Setterwalls Advokatbyrå AB is legal adviser to Alligator Bioscience. Vator Securities AB acts as the issuing agent in connection with the Rights Issue.

(Press release, Alligator Bioscience, SEP 29, 2026, View Source [SID1234671140])