On May 15, 2026 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity, reported financial results for the three months ended March 31, 2026 and provided an update on recent business progress.

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"We continue to advance the CAPTN-3 platform as a core value driver," said Gil Efron, Purple Biotech CEO. "New patient-derived tumor data, generated with our collaborators at Mount Sinai, further supports IM1240’s differentiated tri-specific design and its potential to overcome tumor immune evasion and resistance in difficult-to-treat solid tumors. Importantly, the data continues to support the contribution of the NKG2A arm, which enhanced anti-tumor activity across tested samples and improved the therapeutic index. In parallel, our newly formed Scientific Advisory Board and collaboration with Converge Bio provide important scientific and computational expertise as we seek to expand the broader potential of CAPTN-3. Over the remainder of 2026, we plan to build on this momentum by generating additional efficacy evidence across potential indications and advancing new tri-specific antibody combinations."

Q1 2026 and Recent Clinical & Corporate Highlights:

Generated new patient-derived tumor data supporting IM1240’s differentiated mechanism and anti-tumor activity

● Data generated in the lab of Amir Horowitz, PhD, at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, demonstrated that all tested patient-derived tumor samples responded to IM1240 treatment.

● IM1240 demonstrated activity across treatment-resistant samples, including PD-1 or PD-1/ chemo resistant head and neck squamous cell carcinoma metastatic lymph nodes and enfortumab vedotin + PD-1-resistant muscle-invasive bladder cancer.

● Data further supports the contribution of IM1240’s NKG2A arm, which significantly enhanced anti-tumor activity across tested samples and improved the therapeutic index.

● In a patient-derived non-small cell lung cancer (NSCLC) biopsy, IM1240 induced mature tertiary lymphoid structures (TLS) associated with effective anti-tumor immune response and favorable prognosis, corresponding with observed anti-tumor efficacy.

Established Scientific Advisory Board to support CAPTN-3 development

● Formed a CAPTN-3 Scientific Advisory Board (SAB) composed of experts in T-cell engager development, NK and T cell biology, translational science, and clinical oncology.

● The SAB is expected to provide strategic guidance as the Company advances IM1240 toward clinical development and continues to evaluate broader development opportunities for the CAPTN-3 platform.

Expanded collaboration with Converge Bio to apply generative AI to tri-specific antibody development

● The collaboration leverages Converge Bio’s proprietary generative AI platform to support the design and optimization of novel tri-specific antibodies for oncology.

● The AI-driven strategy is intended to accelerate discovery timelines, improve candidate quality and developability, and expand CAPTN-3’s potential across additional high-value solid tumor targets and resistance mechanisms.

Advancing IM1240 and IM1305 pre-clinical development toward first-in-human studies in 2027

● IM1240 remains the Company’s lead development priority, with IM1305, targeting TROP2, continuing to support the broader platform opportunity.

● Following the prior announcement that further development of CM24 and NT219 would require partnering or additional investment, the Company has redirected resources toward CAPTN-3 as its core development priority.

Financial Results for the Three Months Ended March 31, 2026

Research and Development Expenses were $1.2 million for the three months ended March 31, 2026, reflecting an increase of $0.5 million, from $0.8 million in the same period of 2025. The increase was primarily driven by higher chemistry, manufacturing, and controls (CMC) development activities related to the CAPTN-3 platform.

General and Administrative Expenses were $1.0 million for the three months ended March 31, 2026, compared to $0.6 million in the same period of 2025, representing an increase of $0.4 million, mainly due to higher payroll expenses as well as increased professional services and related expenses.

Adjusted Operating Loss (as reconciled below) was $2.1 million for the three months ended March 31, 2026, compared to $1.3 million in the same period of 2025, reflecting an increase of $0.8 million, primarily attributable to the higher operating expenses described above.

Finance Income, Net was $2.2 million for the three months ended March 31, 2026, compared to $1.0 million in the same period of 2025, reflecting an increase of $1.2 million, mainly due to non-cash warrant-related income due to changes in fair value measurement.

Net Loss was $0.1 million for the three months ended March 31, 2026, compared to a net loss of $0.5 million in the same period of 2025. The decrease in net loss was mainly driven by finance income, net, primarily resulting from changes in the fair value of warrants, partially offset by higher operating expenses.

Adjusted Net Loss (as reconciled below) for the three months ended March 31, 2026, was $2.1 million, an increase of $0.8 million, compared to $1.3 million in the same period of 2025, mainly reflecting financial income related to changes in the fair value of financial instruments.

As of March 31, 2026, Purple Biotech had cash and cash equivalents and short-term deposits of $6.4 million, which is expected to provide the Company with a cash runway into 2027.

Non-IFRS Financial Measures

This press release includes information about certain financial measures that are not prepared in accordance with International Financial Reporting Standards ("IFRS"), including adjusted operating loss and adjusted net loss. These non-IFRS measures are not based on any standardized methodology prescribed by IFRS and are not necessarily comparable to similar measures presented by other companies. Adjusted operating loss and adjusted net loss adjust for non-cash share-based compensation expenses, and adjusted net loss also adjusts for finance income from financial instruments. The Company’s management and board of directors utilize these non-IFRS financial measures to evaluate the Company’s performance. The Company provides these non-IFRS measures of the Company’s performance to investors because management believes that these non-IFRS financial measures, when viewed with the Company’s results under IFRS and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, these non-IFRS measures are not measures of financial performance under IFRS and, accordingly, should not be considered in isolation or as alternatives to IFRS measures as indicators of operating performance. Further, these non-IFRS measures should not be considered measures of the Company’s liquidity. A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release.

(Press release, Purple Biotech, MAY 15, 2026, View Source [SID1234665776])

On May 15, 2026 Racura Oncology, an Australian Phase 3 stage clinical biopharmaceutical company, reported that the independent Safety Review Committee (SRC) has completed its review of safety data from Cohort 1 of the ongoing CPACS clinical trial, evaluating the safety and pharmacokinetics of RC220 alone and in combination with doxorubicin in advanced metastatic solid tumor patients.

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Following its review, the SRC recommended that the study continue, noting no safety concerns in patients treated with 40mg/m2 of RC220 as monotherapy, or 40mg/m2 of RC220 in combination with 60mg/m2 of doxorubicin, in the first patient cohort of this groundbreaking trial.

"The SRC’s unanimous recommendation to proceed with the trial, along with the absence of any safety concerns, represents an important milestone for this clinical program," said Daniel Tillett, CEO of Racura Oncology. "These findings support the continued advancement of RC220 into the next cohorts of this study. We wish to thank the patients and their families for their courage and generosity shown by participating in the CPACS trial."

Based on this positive SRC recommendation, Racura plans to proceed to screening of new eligible patients for enrolment in Cohort 2 (80mg/m2 RC220 dose level) using an updated trial protocol, which includes an initial lead-in safety monotherapy cycle of doxorubicin prior to the administration of RC220. This protocol update enables an assessment of the anthracycline-cardioprotective potential of RC220 using a blood-based molecular test.

The Company has received the SRC’s formal written recommendation and has promptly notified the clinical trial sites to initiate enrolment in Cohort 2, as patients present and meet the eligibility criteria.

About Cardioprotection and Anticancer Synergy (CPACS) Trial

The CPACS Phase 1 solid tumor clinical trial is exploring the preclinical discovery that RC220 can provide protection from anthracycline cardiotoxicity while improving the anticancer activity of anthracyclines. Stage 1 of the trial is using ascending doses of RC220 to determine the safety, tolerability, pharmacokinetics, and maximum tolerated combined dose (MTCD) of RC220 in combination with doxorubicin in up to 33 patients using a Bayesian design. The effects on a range of clinical biomarkers, including a blood-based measure of the cardioprotective mechanism of action of RC220, are also being explored in the study.

After interim analysis of the data, the optimal dosage of RC220 in combination with doxorubicin will be assessed in an additional 20 patients in Stage 2 for further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals. This open-label trial is being conducted across multiple sites in Australia, Hong Kong, and South Korea.

About RC220 & (E,E)-bisantrene

RC220 is a proprietary formulation of (E,E)-bisantrene designed to overcome drug solubility issues that prevent safe peripheral intravenous infusion. (E,E)-bisantrene is a clinical validated small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent silencing of the important cancer growth regulator MYC.

(Press release, Racura Oncology, MAY 15, 2026, View Source [SID1234665796])

On May 15, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported results from the Phase 3 trial evaluating two dose levels of fianlimab (LAG-3 inhibitor) in combination with cemiplimab (PD-1 inhibitor) as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma. The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) compared to pembrolizumab (PD-1 inhibitor) monotherapy. No new safety signals were identified with the fianlimab combination.

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High-Dose
Combination
(n=508) Low-Dose
Combination
(n=422) Pembrolizumab
Monotherapy
(n=462) Cemiplimab
Monotherapy*
(n=154)
Primary endpoint:
median PFS, months
(95% Confidence
Interval [CI])

11.5 (6.3, 16.8)

9.6 (6.2, 13.9)

6.4 (4.4, 11.1)

6.3 (4.0, 17.2)

Hazard Ratio (95%
CI)
Relative to
Pembrolizumab

0.845 (0.709,
1.008) 0.931 (0.773,
1.122)#
p-Value p=0.0627 p=0.4661#
*Cemiplimab was used to define contribution of components and was not used in the statistical comparison
# Low dose combination compared against subset of concurrently randomized patients on pembrolizumab (n=421)

Detailed results from the trial will be presented at an upcoming medical meeting.

A Phase 3 head-to-head trial, also in first-line unresectable or metastatic melanoma, evaluating the high-dose fianlimab combination versus Opdualag (nivolumab and relatlimab-rmbw) is ongoing.

The potential uses of fianlimab and cemiplimab described above are investigational, and safety and efficacy of this combination have not been evaluated by any regulatory authority.

About the Phase 3 Trial
This randomized, double-blind Phase 3 trial is investigating the combination of fianlimab and cemiplimab versus pembrolizumab in patients 12 years of age or older with unresectable locally advanced or metastatic melanoma who have not received a previous systemic treatment for advanced disease. The trial enrolled 1,546 patients who were randomized to receive either: 1600 mg fianlimab and 350 mg cemiplimab (high-dose combination) every 3 weeks; 400 mg fianlimab and 350 mg cemiplimab (low-dose combination) every 3 weeks; placebo and 200 mg pembrolizumab every 3 weeks; or placebo and 350 mg cemiplimab every 3 weeks.

(Press release, Regeneron, MAY 15, 2026, View Source [SID1234665777])

On May 15, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that compelling results from its randomized, double-blind, placebo-controlled Phase II trial (AK117-206) of ligufalimab (AK117) will be presented as an oral presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress. The abstract is now available on the EHA (Free EHA Whitepaper) Congress platform.

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Ligufalimab is Akeso’s proprietary next-generation humanized IgG4 anti-CD47 monoclonal antibody. The study evaluated ligufalimab in combination with azacitidine (AZA) and venetoclax (VEN) in patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

The abstract data demonstrated that the ligufalimab-based triplet regimen delivered encouraging efficacy, with significant improvements in survival outcomes. The combination also showed a manageable safety profile, offering a potentially better-tolerated treatment option for this vulnerable patient population.

As of the November 2025 data cutoff, key findings included:

Deep and Durable Tumor Remission

The objective response rate (ORR) was 80.0% in the ligufalimab arm versus 66.7% in the control arm, with a composite complete remission (CRc) rate of 56.7% versus 53.3%. Among patients achieving CRc, the measurable residual disease (MRD) negativity rate was higher in the ligufalimab arm (46.7% versus 36.7%).
Median duration of CRc was substantially longer in the ligufalimab arm at 10.4 months versus 6.5 months in the control arm.
Encouraging Survival Benefit Trend

At a median follow-up of 8.84 months, median overall survival (mOS) in the ligufalimab arm was not yet reached, versus 8.3 months in the control arm. The 9-month overall survival rate was 78.7% in the ligufalimab arm versus 43.1% in the control arm; the 6-month OS rates were 83.3% versus 73.2%, respectively.
Favorable Safety Profile With No New Safety Signals Observed

The incidence of overall treatment-emergent adverse events (TEAEs) and serious adverse events was comparable between treatment arms. The most common TEAEs were generally consistent with those expected in the context of AML and AZA+VEN therapy.
Anemia occurred in 46.7% of patients in the ligufalimab arm versus 50.0% in the control arm.
Notably, ligufalimab has already received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of AML. Akeso is advancing its ligufalimab clinical development programs at a globally competitive pace across both hematologic malignancies and solid tumors. Ligufalimab is also the first anti-CD47 monoclonal antibody worldwide to enter a registrational Phase III clinical trial in solid tumors.

(Press release, Akeso Biopharma, MAY 15, 2026, View Source [SID1234665797])

On May 15, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it has sold an aggregate of 21,607,878 shares of the company’s common stock through its at-the-market ("ATM") facility established through TD Securities (USA) LLC for net proceeds of approximately $69 million. The investment, including participation based on interest received from RA Capital Management, combined with the previously announced unrelated $25 million investment from the Mayo Clinic, brings the total capital raised since the end of the first quarter of 2026 to approximately $94 million and extends the company’s expected cash runway to mid-2027.

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The shares of common stock described above were sold by the company pursuant to an automatically effective shelf registration statement on Form S-3ASR (File No. 333-293981), including the ATM prospectus supplement, filed by the company with the SEC on March 3, 2026. The ATM prospectus supplement and the accompanying prospectus may be obtained from TD Securities (USA) LLC, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]. Electronic copies of the ATM prospectus supplement and the accompanying prospectus are also available on the SEC’s website at View Source

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

(Press release, Sana Biotechnology, MAY 15, 2026, View Source [SID1234665778])