May 2026 – Page 29 – 1stOncology™: Cancer Intelligence Service

Immix Biopharma Announces Pricing of $150 Million Underwritten Offering of Common Stock

On May 21, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a global leader in AL Amyloidosis, reported the pricing of an underwritten registered offering of 16,778,524 shares of its common stock at a price to the public of $8.94 per share. The gross proceeds to Immix from the offering, before deducting the underwriting discounts, commissions and other offering expenses, are expected to be $150 million. The offering is expected to close on or about May 22, 2026, subject to the satisfaction of customary closing conditions.

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Immix intends to use the net proceeds from this offering to fund NXC-201 development, working capital and general corporate purposes. Immix believes that the net proceeds from the offering, together with its existing cash and cash equivalents, will be sufficient to meet the Company’s operational needs into mid-2028.

Morgan Stanley is acting as the lead book-running manager and BofA Securities is acting as book-running manager for the offering. LifeSci Capital, Mizuho and Needham & Company are acting as co-lead managers for the offering.

The securities in the registered offering are being offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-292665), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 9, 2026, and declared effective on January 22, 2026. A prospectus supplement and accompanying prospectus describing the terms of the registered offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from: Morgan Stanley & Co. LLC, attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by phone: 1-866-718-1649 or by email: [email protected].

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

(Press release, Immix Biopharma, MAY 21, 2026, View Source [SID1234665932])

Immix Biopharma Announces 95% Complete Response Rate in Interim Update From relapsed/refractory AL Amyloidosis Clinical Trial NEXICART-2

On May 21, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a global leader in AL Amyloidosis, reported that all four relapsed/refractory AL Amyloidosis MRD-negative patients presented at ASH (Free ASH Whitepaper) 2025 have converted to complete response (CR). The NEXICART-2 CR rate is now 95% (19 out of 20 patients). All CRs were reached within 1 year of follow-up post-dosing. No relapses have been observed as of today for patients who have reached CR. All subsequently enrolled patients for whom MRD results are available are MRD-negative at one month. The next NEXICART-2 update is expected late September 2026.

These results support the Company’s plan to initiate a multi-center, randomized Phase 3 trial in newly diagnosed AL Amyloidosis patients.

"Even in a heavily pretreated population of median 4 prior lines of therapy, we are pleased that NXC-201, as a 5th line of therapy, drives MRD-negativity, converting to durable CRs to-date, indicating that NXC-201 can eliminate the source of toxic light chains that clog up the heart, kidney and liver, causing organ failure and death in relapsed/refractory AL Amyloidosis. As a potential frontline therapy in AL Amyloidosis, we believe there’s potential to transform a usual 2-year treatment, into a one-and-done: NXC-201." Gabriel Morris, President, Chief Financial Officer of Immix Biopharma, added, "We have observed the NEXICART-2 CR rate improving over time. In September 2026 we plan to present updated data from our ongoing NEXICART-2 trial. By end of March 2027, we expect to present 1-year follow-up data of enrolled patients, which we expect will drive BLA submission and commercial launch."

About NEXICART-2
NEXICART-2 (NCT06097832) is a multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. NEXICART-2 is a 45-patient study.

About AL Amyloidosis
AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death.

The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 38,500 patients in 2026.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research as of 2023.

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

(Press release, Immix Biopharma, MAY 21, 2026, View Source [SID1234665931])

HUTCHMED and Innovent Jointly Announce NMPA Approval for ELUNATE® (Fruquintinib) in Combination with TYVYT® (Sintilimab Injection) for the Treatment of Patients with Locally Advanced or Metastatic Renal Cell Carcinoma

On May 21, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) and Innovent Biologics, Inc. ("Innovent", HKEX:1801) reported that the New Drug Application (NDA) for the combination of ELUNATE (fruquintinib) and TYVYT (sintilimab injection) has been granted approval by the China National Medical Products Administration ("NMPA") for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKI) therapy and have not received programmed death receptor-1 ("PD-1") or programmed death-ligand 1 ("PD-L1") inhibitor therapy in the first-line setting.

The approval is supported by data from FRUSICA-2, a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of patients with locally advanced or metastatic renal cell carcinoma. The study met its primary endpoint of progression free survival ("PFS") as assessed by blinded independent central review ("BICR").

"The rapid advancements in targeted therapies, immunotherapies, and their combination regimens have led to a significant evolution in the treatment landscape for advanced renal cell carcinoma. Optimizing the selection of treatment for individual patients is a key focus of clinical interest," said Professor Dingwei Ye of Fudan University Shanghai Cancer Center and co-lead Principal Investigator of the FRUSICA-2 study. "The approval of the fruquintinib and sintilimab combination underscores its potential to address the pressing medical needs of patients with this challenging disease."

"The FRUSICA-2 trial results provided compelling evidence that the fruquintinib and sintilimab combination could play a meaningful role in shaping second-line treatment strategies for advanced renal cell carcinoma," said Professor Zhisong He of Peking University First Hospital and co-lead Principal Investigator of the FRUSICA-2 study. "We are optimistic about the clinical implications of this approval as we strive to provide effective treatment options for patients."

"This approval reaffirms our deep commitment to delivering innovative therapies to patients facing advanced renal cell carcinoma in China, where second-line treatment options remain limited," said Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED. "We are excited to continue pushing the boundaries of our research — across monotherapies, combination strategies, and exciting new platforms such as our ATTC technology — to unlock even greater therapeutic potential across various tumor types, ultimately providing more impactful and transformative solutions to patients."

Dr Hui Zhou, Chief R&D Officer of Oncology of Innovent, stated: "The approval is a significant milestone for patients with advanced renal cell carcinoma in China. It further validates the potential of the sintilimab plus fruquintinib combination regimen, now approved for two difficult-to-treat cancers. We are also proud to achieve the 10th approved indication for sintilimab (TYVYT), and remain committed to advancing clinical value optimization to benefit an even broader population of cancer patients."

About The FRUSICA-2 Trial

Results from the Phase III part of the study were presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. As of the PFS final analysis cutoff of February 17, 2025, the median follow-up was 16.6 months. The median PFS as assessed by BICR was 22.2 months with fruquintinib plus sintilimab, compared to 6.9 months with axitinib/everolimus (stratified hazard ratio [HR] 0.373; stratified log-rank p<0.0001). The objective response rate (ORR) was 60.5% vs 24.3% (Odds Ratio 4.622, p<0.0001), and the median duration of response (DoR) was 23.7 months vs 11.3 months, respectively. Overall survival data were still evolving at the time of data cutoff with maturity of approximately 20%. Efficacy benefits were observed in all prognostic risk groups, as defined by the International mRCC Database Consortium (IMDC) criteria. The safety profile of the fruquintinib and sintilimab combination was consistent with the known profiles of each individual treatment. Additional details may be found at clinicaltrials.gov, using identifier NCT05522231.

About Kidney Cancer and Renal Cell Carcinoma

It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.1 In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.2 Approximately 90% of kidney tumors are renal cell carcinoma.

About Fruquintinib

Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy.3

About Fruquintinib Approvals

Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE. It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable to receive anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type) in China. It was included in China’s National Reimbursement Drug List (NRDL) in January 2020.

The combination of ELUNATE (fruquintinib) and TYVYT (sintilimab injection) has conditional approval in China for the treatment of patients with advanced mismatch repair proficient (pMMR) endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation.

Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA. Fruquintinib received approval for the treatment of previously treated metastatic colorectal cancer in the US, Europe, Japan and many other countries around the world.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/PD-L1 pathway, and reactivates T-cells to kill cancer cells.

(Press release, Hutchison China MediTech, MAY 21, 2026, View Source [SID1234665930])

HCW Biologics Inc. Announces Pricing of Approximately $4.0 Million Private Placement Offering At-the-Market Under Nasdaq Rules

On May 21, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics"), (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat autoimmune, cancer and senescence-associated dysplasia, reported the pricing of its private placement of an aggregate of 2,846,975 units at a purchase price of $1.405 per unit priced at-the-market under Nasdaq rules to a group of healthcare investors (the "Investors"). Each unit consists of (i) one share of common stock at a purchase price of $1.28 per share (or, in lieu thereof, one pre-funded warrant at a purchase price of $1.2799 per pre-funded warrant with an exercise price of $0.0001 per share) and (ii) one warrant at a purchase price of $0.125 per warrant, each to purchase one share of common stock. The warrants will have an exercise price of $1.28 per share, will be exercisable immediately upon issuance, and will expire on the five and one-half year anniversary of the original issuance date. The shares of common stock (or pre-funded warrants) and the warrants comprising the units are immediately separable and will be issued separately in this offering. The closing of the offering is expected to occur on or about May 21, 2026, subject to the satisfaction of customary closing conditions.

E.F. Hutton & Co. LLC is acting as the sole placement agent for the offering.

The Company intends to use the net proceeds from this offering to continue clinical trials for HCW9302, advance its IND-enabling studies for its T-Cell Engager, HCW11-018b, and its second-generation immune checkpoint inhibitor, HCW11-040, and funding for general corporate purposes and to pay off certain debts and settlements.

On May 21, 2026, the Company also entered into a registration rights agreement with the Investors, pursuant to which the Company agreed to submit to the U.S. Securities and Exchange Commission (the "SEC") an initial registration statement on Form S-1 within 60 days of the closing date covering the resale of the purchased shares and underlying shares for warrants, which may be issued from time to time upon the exercise of such warrants, and to use commercially reasonable efforts to cause the registration statement to be declared effective by the SEC within [60] days following the closing of the Offering.

The number of shares the Company can issue to an Investor, including those shares issued upon the exercise of pre-funded warrants from time to time, may not exceed 4.99% of the number of shares of our Common Stock outstanding immediately after giving effect to such issuances.

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

(Press release, HCW Biologics, MAY 21, 2026, View Source [SID1234665929])

Genmab to Highlight Advances Across Its Oncology Portfolio at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2026 Congress

On May 21, 2026 Genmab A/S (Nasdaq: GMAB) reported that 23 abstracts, including 20 abstracts evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, will be presented or published at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL, from May 29-June 2, and at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden, from June 11-14.

Key presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) will highlight data evaluating the potential utility of epcoritamab across multiple settings, including as a monotherapy, in combination regimens, in fixed-duration use and in earlier lines of therapy. Oral sessions will feature the first presentation of the full results from the Phase 3 EPCORE DLBCL-1 trial comparing epcoritamab monotherapy to investigator’s choice chemotherapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), as well as additional data from the Phase 3 EPCORE FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) versus R2 alone in patients with R/R follicular lymphoma (FL). Additional presentations will include real-world evidence and health economic and outcomes research data, as well as overviews of trials-in-progress evaluating late-stage medicines.

"This year at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper), Genmab will once again present data highlighting the depth and breadth of the epcoritamab development program, including encouraging results across multiple treatment settings for patients with B-cell malignancies. These findings underscore the versatility of epcoritamab as a monotherapy, in combination regimens and as a potential core therapy across the spectrum of B-cell malignancies," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Additional presentations and publications at ASCO (Free ASCO Whitepaper) will further reflect our commitment to advancing other antibody-based therapeutics."

All abstracts accepted for presentation and publication have been published and may be accessed online via the ASCO (Free ASCO Whitepaper) Meeting Library and EHA (Free EHA Whitepaper) Open Access Library.

Abstracts accepted for presentation at ASCO (Free ASCO Whitepaper):

Epcoritamab:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
7002*

Phase 2 trial of epcoritamab in combination with rituximab-mini CVP for older unfit/frail or anthracycline-ineligible adult patients with newly diagnosed diffuse large B-cell lymphoma: Interim futility analysis Oral presentation

Saturday, May 30, 3:00 PM-6:00 PM CDT
7061 Epcoritamab (epcor) + chemoimmunotherapy (CIT) in patients (pts) with relapsed/refractory large B cell lymphoma (R/R LBCL) eligible for autologous stem cell transplant (ASCT): Pooled results from Arms 4 and 10 of EPCORE NHL-2 Poster

Monday, June 1, 9:00 AM-12:00 PM CDT
e19003

NHL-6: Phase 2 study of subcutaneous (SC) epcoritamab as outpatient treatment for 2L+ relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) Publication Only

*Investigator-led trial

Rinatabart sesutecan (Rina-S):

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
TPS5646 RAINFOL-03 (ENGOT-EN-31/GOG-3128): A phase 3, open-label, randomized study of Rinatabart sesutecan vs investigator’s choice of chemotherapy in patients with endometrial cancer after platinum-based chemotherapy and programmed death ligand 1 inhibition Poster

Monday, June 1, 9:00 AM-12:00 PM CDT
TPS5641 RAINFOL-04 (ENGOT-OV96/GOG-3134): A phase 3, open-label, randomized study of Rinatabart sesutecan plus standard of care (SOC) vs SOC as maintenance treatment after second-line platinum-based chemotherapy in patients with recurrent platinum-sensitive ovarian cancer Poster Monday, June 1, 9:00 AM-12:00 PM CDT

Petosemtamab:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
TPS8662 Petosemtamab plus pembrolizumab as first-line (1L) treatment of PD-L1 high metastatic non-small cell lung cancer (NSCLC): Global phase 2 trial Poster

Sunday, May 31, 9:00 AM-12:00 PM CDT
Abstracts accepted for presentation at EHA (Free EHA Whitepaper):

Epcoritamab:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
S229

Clinically Relevant Subgroup Analysis from the Randomized Phase 3 EPCORE FL-1 Trial: Treatment (Tx) Effect of Epcoritamab with Lenalidomide and Rituximab (R2) in R/R Follicular Lymphoma (FL) Oral Presentation

Thursday, June 11, 16:45-18:00 CEST
S235 Results From EPCORE DLBCL-1: Randomized Phase 3 Study of Epcoritamab (Epcor) Vs Investigator’s Choice Chemoimmunotherapy (CIT) in Patients with Relapsed/Refractory Large B-cell Lymphoma (R/R LBCL) Oral Presentation

Friday, June 12,
17:15-18:30 CEST

S153*

Fixed Duration Venetoclax Plus Epcoritamab Shows Favorable Tolerability and High Response Rates with Early Molecular Responses in R/R CLL/SLL: Interim Analysis of the Randomized HOVON 165/AETHER Trial Oral Presentation

Sunday June 14,
11:00-12:15 CEST
*Investigator-led trial

PF977

Sustained Remissions Beyond 4 Years with Epcoritamab Monotherapy: Long-term Follow-up Results from the Pivotal EPCORE NHL-1 Trial in Patients with Relapsed or Refractory Large B-cell Lymphoma Poster

Friday, June 12, 18:45-19:45 CEST

PF1007

Epcoritamab + R-mini-chop Results in 2-year Remissions and High MRD-negativity Rates in Elderly Patients with Newly Diagnosed DLBCL: Results from the EPCORE NHL-2 Trial Poster

Friday, June 12, 18;45-19:45 CEST

PF1069

Reduced CD20 Expression and Intratumoral CD3+ T Cells Following Epcoritamab Treatment Are Associated with Progressive Disease in a Subset of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Poster

Friday, June 12, 18:45-19:45 CEST

PF1081

Pharmacodynamic Biomarkers Support the Clinical Benefit of Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL): Analyses from EPCORE FL-1 Poster

Friday, June 12, 18:45-19:45 CEST

PS2035

Anchored Matching-adjusted Indirect Comparison of Epcoritamab, Lenalidomide, and Rituximab Vs Tafasitamab, Lenalidomide, and Rituximab in Relapsed/Refractory Follicular Lymphoma: EPCORE FL-1 Vs Inmind Poster

Saturday, June 13, 18:45-19:45 CEST
PS2042

Comparative Effectiveness of Epcoritamab, Lenalidomide, and Rituximab in EPCORE FL-1 Vs Real-world Chemoimmunotherapy in Relapsed/Refractory Lymphoma Poster