Entry into a Material Definitive Agreement

On May 29, 2026, Lisata Therapeutics, Inc. (the "Company" or "Lisata") and Kuva Labs Inc., a Delaware corporation ("Parent"), together with Kuva Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of Parent ("Purchaser"), reported to have entered into an amendment (the "Amendment") to the previously announced Agreement and Plan of Merger, dated as of March 6, 2026, by and among Parent, Purchaser and the Company (the "Original Merger Agreement" and, as it may be amended from time to time, the "Merger Agreement"). Pursuant to the Amendment, the Company, Parent and Purchaser agreed to amend the offer price per share of common stock, par value $0.001 per share (the "Common Shares"), of the Company under the Original Merger Agreement from (A) (i) $5.00 per Common Share, net to the seller in cash, without interest, but subject to any applicable withholding of taxes plus (ii) one (1) non-tradeable contingent value right (each, a "CVR") which represents the contractual right to receive a contingent cash payment of $1.00 per CVR, subject to achievement of a specified milestone, to (B) (i) $4.00 per Common Share, net to the seller in cash, without interest, but subject to any applicable withholding of taxes plus (ii) one non-tradeable contingent value right which represents the contractual right to receive two contingent cash payments of up to an aggregate of $3.00 per CVR, subject to achievement of specified milestones.

Pursuant to the Amendment, the form of contingent value rights agreement attached to the Original Merger Agreement was amended and restated in its entirety as set forth in the form of contingent rights agreement attached to the Amendment as Exhibit A thereto (the "CVR Agreement"). Under the CVR Agreement, each CVR represents a non-tradable contractual contingent right to receive one (1) contingent cash payment of $1.25 per CVR (the "First Milestone Payment") upon the achievement of, with respect to a Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating LSTA1 when added to standard of care (temozolomide) versus temozolomide and matching LSTA1 placebo in subjects with newly diagnosed Glioblastoma Multiforme (GBM) (Protocol Number: LSTA1-GBM-2A), (i) completion of enrollment of such trial, (ii) the enrollment of at least 90% of the target number of subjects of such trial or (iii) the termination of such trial by its sponsor for any reason (with the term "enrollment" meaning the process of registering qualified participants into such trial after confirming eligibility and obtaining informed consent, marking the point at which the participant becomes a subject of such trial) (the "First Milestone"), which shall be due and payable on the later of December 15, 2026 and the date that is forty-five (45) days following the achievement of the First Milestone, and one (1) contingent cash payment of $1.75 per CVR (the "Second Milestone Payment" and, collectively with the First Milestone Payment, the "Milestone Payments") upon the achievement of the filing or formal acceptance for review by any Governmental Body (as defined in the Merger Agreement) of any (i) New Drug Application submitted to the FDA in the U.S. in accordance with the FDCA requesting approval to market or commercialize any pharmaceutical product that contains or incorporates the product candidate referred to as certepetide (formerly LSTA1 or CEND-1), alone or in combination with one or more other therapeutically active ingredients, including all formulations, dosages, or modes of delivery thereof (the "CVR Product") for any indication or patient population, or (ii) analogous application or submission to any other applicable Governmental Body requesting approval to market or commercialize the CVR Product for any indication or patient population (the "Second Milestone" and, collectively with the First Milestone, the "Milestones"), which shall be due and payable on the date that is forty-five (45) days following the achievement of the Second Milestone, in each case, prior to the earliest of (a) the mailing by the Rights Agent to the address or the payment of the Rights Agent to each holder of the Milestone Payment, (b) 11:59 p.m. New York City Time on the seventh (7th) anniversary of the Closing Date (as defined below), and (c) termination of the CVR Agreement. The CVR Agreement provides that, in the event that Parent fails to pay the First Milestone Payment in full on or prior to the date that it is due and payable, all unpaid amounts shall accrue interest commencing on such date, at a rate equal to the least of (x) ten percent (10%) per annum, (y) the Secured Overnight Financing Rate as published by the Federal Reserve Bank of New York (or any successor administrator thereof) as of such date, plus five percent (5%) per annum, and (z) the maximum rate permitted under applicable Law, in each case calculated on the basis of a 365-day year and the actual number of days elapsed, until all such amounts are paid in full.

In addition, pursuant to the Amendment, the Company, Parent and Purchaser agreed that, upon commencement of the tender offer for all of the outstanding shares of common stock of the Company (the "Offer") on June 1, 2026, the date by which Purchaser is obligated under the Merger Agreement to commence the Offer would automatically be extended from May 29, 2026 to June 1, 2026, or such other date as may be agreed to between the Company and Parent. The Amendment also extended the Outside Date (as defined in the Merger Agreement) from July 1, 2026 to July 6, 2026.

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(Filing, Lisata Therapeutics, MAY 29, 2026, View Source [SID1234666197])

Dizal Announces Phase 3 WU-KONG28 Results: ZEGFROVY® (Sunvozertinib) Outperforms Platinum-Doublet Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer

On May 29, 2026 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, reported the results from the multinational phase 3 WU-KONG28 study showing that ZEGFROVY (sunvozertinib) monotherapy demonstrated superior anti-tumor efficacy, compared to platinum-doublet chemotherapy, in untreated NSCLC patients with EGFR exon 20 insertion mutations (exon20ins). These data were presented as a Late-Breaking Abstract Oral Presentation (#LBA8500) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine (The NEJM).

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As of January 16, 2026, 324 patients were randomized in a 1:1 ratio to receive either ZEGFROVY or chemotherapy. ZEGFROVY, administered at 300 mg once daily, demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS), the primary endpoint of the study, as assessed by blinded independent central review (BICR). The overall safety profile was consistent with previous studies, no new safety finding.

Median PFS was 10.3 months with ZEGFROVY versus 7.5 months with chemotherapy (HR=0.65; P=0.0008).
BICR-assessed best objective response rate (BoR) was 68.1% with ZEGFROVY versus 35.4% with chemotherapy, and median duration of response (DoR) was 11.2 months versus 7.1 months.
The overall safety profile was consistent with previous studies, with adverse reactions generally manageable and reversible.
"Over the past two decades, treatment for EGFR-mutated NSCLC has evolved substantially, with targeted therapies transforming outcomes. However, patients with EGFR exon20ins NSCLC have continued to face limited treatment options, particularly in the first-line setting," said John Heymach, M.D., Ph.D, Chair of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, and presenting author. "The WU-KONG28 trial marks a clinical turning point. The data demonstrate that a single-agent targeted oral regimen can deliver superior antitumor efficacy over conventional chemotherapy, offering a practice-changing alternative that may spare treatment-naïve patients from initial cytotoxic treatment."

"The current first-line management of EGFR exon20ins NSCLC remains chemotherapy-bound, highlighting a substantial unmet need for a precision targeted therapy that simultaneously balances robust efficacy, favorable safety, and oral administration convenience," said Caicun Zhou, M.D., Ph.D, Shanghai East Hospital affiliated with Tongji University, Lead Principal Investigator of WU-KONG28, and corresponding author of The NEJM article. "The WU-KONG28 study demonstrates that ZEGFROVY monotherapy yields superior antitumor efficacy compared to platinum-doublet chemotherapy, while maintaining a manageable safety profile and enhanced convenience. These findings support the potential to usher the first-line treatment of EGFR exon20ins NSCLC into a chemotherapy-free era, providing global patients a more precise single-agent targeted therapeutic option."

"The presentation of WU-KONG28 as an ASCO (Free ASCO Whitepaper) Late-Breaking Abstract (LBA) and its simultaneous publication in The NEJM underscore the clinical significance and quality of the study," said Dr. Xiaolin Zhang, CEO of Dizal. "WU-KONG28 study demonstrates that ZEGFROVY can provide superior benefits for treatment naïve patients. It is the first positive study for this difficult disease, providing a chemotherapy-free option for patients globally. It is the first global phase 3 study conducted by Dizal. I am deeply grateful to our patients, their families, and investigators of the study. I am very proud of our team for this fantastic achievement."

ZEGFROVY has previously been granted accelerated approvals in both the U.S. and China for the treatment of relapsed or refractory EGFR exon20ins NSCLC. Based on the positive results of WU-KONG28, the New Drug Application (NDA) for ZEGFROVY as a first-line treatment for EGFR exon20ins NSCLC has been accepted and granted Priority Review designation by China’s National Medical Products Administration (NMPA).

About ZEGFROVY(sunvozertinib)

ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication.

In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins.

ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals including Cancer Discovery, The Lancet Respiratory Medicine, Journal of Clinical Oncology, and The New England Journal of Medicine.

About WU-KONG28

WU-KONG28 is a multinational, open-label, randomized confirmatory phase 3 study evaluating ZEGFROVY versus platinum-based chemotherapy as first-line treatment in advanced NSCLC patients with EGFR exon20ins. The study enrolled patients across 15 countries and regions in Asia, Europe, North America and South America. The primary endpoint is progression-free survival (PFS) assessed by BICR.

(Press release, Dizal Pharma, MAY 29, 2026, View Source [SID1234666226])

Enterome receives U.S. FDA Orphan Drug Designation for EO2463 OncoMimics™ to treat “watch-and-wait” indolent non-Hodgkin lymphoma

On May 28, 2026 Enterome SA, a clinical-stage company pioneering OncoMimics, a new class of off-the-shelf, multi-targeted in vivo immune therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to EO2463 for the treatment of patients with indolent non-Hodgkin lymphoma (iNHL) in the low-tumor-burden, "watch-and-wait" setting. The U.S. FDA Fast Track designation was also granted in October 2025 to EO2463 for follicular lymphoma in the watch-and-wait setting, further underscoring its potential and the unmet medical need.

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The US FDA orphan drug designation (ODD) confers several substantial financial, regulatory, and strategic advantages to sponsors developing therapies for rare diseases affecting fewer than 200,000 people in the United States. For example, upon marketing approval, orphan-designated products receive 7 years of market exclusivity in the US.

"Receiving FDA Orphan Drug Designation is an important regulatory milestone for EO2463 and re-affirms our strong commercial potential. Today, the only option for non-symptomatic low tumor burden "watch-and-wait" iNHL patients is to go without treatment and be observed until the cancer progresses. We believe this places undue stress on patients and their families and is unacceptable; it is gratifying to see the U.S. regulatory agency recognizes that ‘watch-and-wait’ patients deserve a real treatment option like EO2463," said Pierre Belichard, Chief Executive Officer of Enterome. "Together with the Fast Track designation granted late last year, FDA’s ODD further facilitates and validates our efforts to advance EO2463 toward registrational development in the watch-and-wait population. We are actively engaging with potential partners and investors to find the best path forward to rapidly advance EO2463 development in this indication."

Data from SIDNEY, which have been reported at multiple peer-reviewed medical conferences, demonstrate that EO2463 is particularly well suited for watch-and-wait iNHL patients because it has been well tolerated in clinical testing and has shown potentially disease modifying monotherapy activity in patients who generally are not eligible to receive anti-lymphoma treatment under current practice until their disease progresses. Data also suggest that EO2463 may be highly complementary when used in combination with marketed cancer therapeutics, offering potential additional disease modifying effects.

In the low-tumor-burden watch-and-wait population of SIDNEY Cohort 2, Enterome reported that EO2463 monotherapy produced a 52.6% objective response rate in 19 evaluable patients with follicular lymphoma and a 47.6% objective response rate in the overall group of 21 evaluable patients with follicular lymphoma or marginal zone lymphoma, including 14.3% complete responses and 33.3% partial responses.

Separately, Enterome reported that EO2463 rapidly induced extensive in vivo expansion of B-cell-target-specific CD8 T cells and established a correlation between EO2463-induced and B-cell-target-specific CD8 T-cell expansion and Lugano objective response, suggesting this immune readout may serve as a predictive biomarker in indolent NHL, something that would further serve to alleviate anxiety in watch-and-wait patients and help physicians decide which patients to monitor more closely.

And in addition to the impact in watch-and-wait patients, Enterome reported that EO2463 combined with lenalidomide and rituximab achieved a 60% complete response rate in 20 patients with relapsed/refractory follicular and marginal zone lymphoma, was well tolerated, and showed CD8 T-cell expansion correlating with the probability of complete remission, findings the company described as complementary to the monotherapy signal seen in watch-and-wait patients and show that EO2463 may also be complementary when used in combination with rituximab and other cancer therapeutics.

SIDNEY is an ongoing open-label Phase 1/2 study evaluating the safety, tolerability, immunogenicity and preliminary efficacy of EO2463 as monotherapy and in combination regimens in up to 55 patients with follicular lymphoma and marginal zone lymphoma. The trial includes a dedicated watch-and-wait monotherapy cohort, a first-line low-tumor-burden combination cohort with rituximab, and relapsed/refractory cohorts treated with EO2463 plus lenalidomide and rituximab.

EO2463 is an off-the-shelf OncoMimics active immunotherapy composed of four synthetic microbial-derived peptides designed to mimic the B-cell lineage markers CD20, CD22, CD37 and CD268 (BAFF receptor), plus the helper peptide UCP2. According to Enterome, this multi-target approach is intended to expand pre-existing memory CD8 T cells, selectively target malignant B cells, broaden target coverage and reduce the risk of antigen escape.

OncoMimics consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs) of solid tumors, or cell linage markers (e.g. as observed in B cell lymphomas). These antigens induce a fast and potent in vivo expansion of cytotoxic memory CD8 T-cells, primed by gut bacteria, and cross-reactive with TAAs/B cell markers. Because the peptides are "non-self", OncoMimics avoid the self-tolerance that limits many cancer immunotherapies to enable rapid, potent, and durable responses to tumors. The synthetically produced peptides are designed in silico, mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple high-affinity peptides to broaden target coverage and mitigate tumor heterogeneity.

(Press release, Enterome, MAY 28, 2026, View Source [SID1234666144])

Innovent Biologics and Pfizer Enter Global Strategic Collaboration to Accelerate Development of Innovative Oncology Medicines

On May 28, 2026 Innovent Biologics, Inc. (01801.HK) and Pfizer Inc. (NYSE: PFE), reported the companies have entered into a strategic global licensing and collaboration agreement for the research and development of 12 promising new breakthrough early-stage and de novo cancer medicines. The partnership includes licensing, co-development, and co-commercialization opportunities across a diverse portfolio of antibody-drug conjugates (ADCs) with novel differentiated payloads and multi-specific antibodies with differentiated immune-engaging features and unique designs.

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The strategic collaboration brings together Innovent’s scientific discovery and clinical capabilities in oncology innovation with Pfizer’s deep scientific expertise, global clinical development capabilities, regulatory leadership and commercial scale, which are highly complementary to each company’s core areas of interest.

The agreement spans a portfolio of 12 programs comprising eight Innovent-originated early-stage programs and four Pfizer-proposed discovery programs. The companies will co-develop and share costs for select programs as they advance these programs through clinical development.

"This agreement brings together best-in-industry expertise of Pfizer and Innovent to advance novel cancer medicines to patients at a global scale," said Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent. "By leveraging both companies’ complementary resources, we can develop our early-stage oncology pipeline with greater speed and impact to help bring innovative therapies to patients more efficiently worldwide. Furthermore, co-developing and co-commercializing key projects in the U.S. and Europe expands Innovent’s global reach. At Innovent, we are laying the foundation for a truly global oncology platform that can deliver meaningful and lasting benefits for patients around the world."

"At Pfizer, everything we do starts with patients and the urgency to change what’s possible for people living with cancer," said Jeff Legos, Chief Oncology Officer, Pfizer. "This collaboration brings together two highly complementary engines of innovation with a shared ambition to move faster, go further and deliver truly transformative medicines to patients who are waiting. By combining Innovent’s discovery and early clinical development with Pfizer’s global research and development and commercialization capabilities, we have an opportunity not only to strengthen our pipeline, but to accelerate the delivery of breakthroughs that can redefine standards of care and make a meaningful difference in patients’ lives."

According to the agreement, Innovent will conduct development of these programs through Phase 1, powered by its proprietary discovery engine and robust early clinical capabilities, after which Pfizer will lead future global development. The agreement also sets out the following licensing and commercialization structure:

Innovent and Pfizer will co-develop four programs globally and share the development costs. The companies will co-commercialize in the United States and Europe*, and share the profits. Innovent will retain Greater China rights to these programs.
Pfizer will receive an exclusive license outside Greater China for four programs, and will be responsible for the majority of the development costs; and
Pfizer will receive an exclusive global license for four programs, and will be responsible for the global development costs.
Under the financial terms of the agreement, Innovent will receive a $650 million upfront payment and is eligible for up to $9.85 billion in development, regulatory and commercial milestone payments, bringing the total value of the deal to up to $10.5 billion. Additionally, Innovent will receive up to double-digit royalties on sales of each licensed product if approved. For the ‘co-developed, co-commercialized’ programs, the two companies will share the profits in the U.S. and Europe.

The closing of the transaction is subject to fulfillment of required regulatory approvals.

(Press release, Innovent Biologics, MAY 28, 2026, View Source [SID1234666160])

CG Oncology to Present at Upcoming Investor Conferences in June

On May 28, 2026 CG Oncology, Inc. (NASDAQ: CGON) reported that Arthur Kuan, Chairman, President & Chief Executive Officer, will participate in fireside chat presentations at the Jefferies Global Healthcare Conference and the Goldman Sachs 47th Annual Global Healthcare Conference this month. The details of the upcoming events are as follows:

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Jefferies Global Healthcare Conference
Date: Wednesday, June 3, 2026
Presentation Time: 10:30-11:00 AM ET
Location: New York, New York

Goldman Sachs 47th Annual Global Healthcare Conference
Date: Tuesday, June 9, 2026
Presentation Time: 2:40-3:15 PM ET
Location: Miami, Florida

Interested parties may access the live audio webcast for the conferences from the Investor Relations section of the company’s website at www.cgoncology.com. The webcast replays will be available shortly after the conclusion of the live presentations and archived for approximately 90 days.

(Press release, CG Oncology, MAY 28, 2026, View Source [SID1234666176])