• Durable responses observed across multiple tumor types during dose escalation
  • MGC026 demonstrated 27% best overall response rate (6/22 patients; 4 confirmed and 2 unconfirmed PRs) in heavily pretreated SCCHN patients
  • MGC026 demonstrated manageable safety and tolerability profile with no treatment-related discontinuations in SCCHN patients
  • Plan to initiate front-line SCCHN cohort evaluating MGC026 in combination with pembrolizumab

ROCKVILLE, MD, Oct. 23, 2026 (GLOBE NEWSWIRE) — MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today announced positive interim data from its Phase 1 study evaluating MGC026, a B7-H3-directed antibody-drug conjugate (ADC), in patients with advanced solid tumors. These Phase 1 data were presented today at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain. These results demonstrated durable activity across a broad range of solid tumors, which the Company believes supports expanded development of MGC026 in front-line metastatic squamous cell carcinoma of the head and neck (SCCHN) in combination with pembrolizumab.

“The emerging profile of MGC026 reinforces our conviction that this molecule has the potential to play an important and differentiated role in the treatment of advanced solid tumors,” said Eric Risser, President and Chief Executive Officer of MacroGenics. “We believe MGC026 is well positioned through the combination of a highly selective B7-H3-targeting antibody, a proprietary drug-linker technology and a potent TOP1 inhibitor payload.”

Overall MGC026 Safety and Dose Selection

As of the September 1, 2026 data cutoff, 85 patients had been treated across the dose-escalation and dose-expansion cohorts. Across this full safety population, treatment-related adverse events (TRAEs) led to discontinuation in 5% of patients, and no Grade 5 TRAEs were reported. Grade ≥3 TRAEs occurred in 51% of patients. The most common Grade ≥3 TRAEs observed in ≥10% of participants were neutropenia (27%) and anemia (25%). No cases of interstitial lung disease (ILD), pneumonitis or ocular toxicity were observed.

In the 32-patient dose-escalation portion, patients with advanced and metastatic solid tumors received MGC026 at doses ranging from 1 mg/kg to 9 mg/kg administered every three weeks (Q3W) and had received a median of four prior lines of systemic therapy (range 1-8). Pharmacokinetic analyses demonstrated dose-dependent exposure for the ADC and unconjugated payload, supporting selection of the 7.5 mg/kg Q3W regimen for continued evaluation across all tumor-specific expansion cohorts.

Durable Antitumor Activity Across Solid Tumors in Dose Escalation


Among 17 response-evaluable patients representing 10 different tumor types who received MGC026 at doses of at least 6 mg/kg in dose escalation, the confirmed objective response rate was 29% (5/17), and the disease control rate was 65% (11/17). Responses were durable, with a median duration of response (mDOR) of 10.2 months. MacroGenics believes these findings highlight the potential of MGC026 to deliver meaningful and durable clinical benefit in a patient population with advanced solid tumors that were refractory to prior treatments.

Encouraging Activity in Heavily Pretreated SCCHN Patients

As part of the Phase 1 study, MacroGenics is evaluating MGC026 in an ongoing Simon’s 2-stage tumor-specific expansion cohort in recurrent/metastatic SCCHN. The study is designed to enroll 40 patients treated at a dose of 7.5 mg/kg Q3W. The interim results reported here are based on a September 1, 2026 data cutoff and include 27 patients evaluable for safety and 22 patients evaluable for response.

Patients were heavily pretreated, with 46% of the response-evaluable participants having received three prior lines of systemic therapy and 41% having received four or more prior lines (median was 3 prior lines [range 1-7]). MGC026 demonstrated encouraging antitumor activity in these SCCHN patients, achieving a best overall response rate of 27% (6/22), including four confirmed and two unconfirmed partial responses (PRs), and a disease control rate of 64% (14/22). Activity appeared higher among patients with HPV-positive disease, with five of the responses observed (5/16) in this population.

MGC026 demonstrated a manageable safety profile in this heavily pretreated and difficult-to-treat SCCHN population. No TRAEs led to treatment discontinuation, and no cases of ILD, pneumonitis or ocular toxicity were observed. Grade ≥3 TRAEs occurred in 48% of patients. The only two Grade ≥3 TRAEs observed in ≥10% of participants were anemia (30%) and neutropenia (26%). The TRAEs observed in Stage 1 were well managed and reversible. Many of the patients who experienced hematologic toxicities had previously received platinum- and/or taxane-based chemotherapy. Based on these encouraging initial findings, enrollment continues in Stage 2 of the ongoing Phase 1 study, with updated data expected in mid-2027.

“These preliminary Phase 1 data for MGC026 are encouraging and demonstrate a manageable safety profile and promising antitumor activity in heavily pretreated patients with advanced solid tumors,” said Apostolia M. Tsimberidou, M.D., Ph.D., M.B.A., of The University of Texas MD Anderson Cancer Center and the lead principal study investigator. “Importantly, of 22 heavily pretreated patients with SCCHN (expansion cohort), six (27.3%) had a partial response. There was no drug-related treatment discontinuation, and no pneumonitis, ocular toxicities, or unexpected toxicities were noted. Together, these findings support the continued clinical development of MGC026 in SCCHN and across multiple tumor types, including evaluation in combination regimens and earlier lines of therapy.”

Next Development Steps in SCCHN

MacroGenics believes the emerging profile of MGC026 supports evaluation in earlier-line treatment settings, where the molecule’s orthogonal mechanism of action and non-overlapping toxicity profile may potentially complement immune checkpoint inhibition. The Company plans to initiate an expansion cohort in early 2027 evaluating MGC026 in combination with pembrolizumab in front-line patients with PD-L1 positive (CPS ≥1) recurrent or metastatic SCCHN.

Commenting on the emerging SCCHN treatment landscape, Barbara Burtness, M.D., Anthony N. Brady Professor of Medicine and Chief of Head and Neck Cancers, Yale Cancer Center, commented: “As new therapies emerge in head and neck cancer, differentiation will increasingly depend not only on antitumor activity, but also on durability, tolerability and the ability to be incorporated into combination regimens. I believe the developing clinical profile of MGC026 positions this agent favorably among emerging therapies. The planned pembrolizumab combination study represents an important next step in determining the potential role of MGC026 in earlier treatment settings.”

Poster Presentation Details

Title: Phase 1, first-in-human study of MGC026, a B7-H3–targeted antibody-drug conjugate (ADC) in advanced solid tumors
Lead author: Rachel E. Sanborn, M.D.
Session: Developmental therapeutics
Poster number: 1020P
Date and time: Friday, October 23, 2026, from 15:15 to 16:00 CEST

A copy of the above ESMO poster presentation and a supplemental slide presentation are available on the Company’s Investor Relations website or through the direct links below:

About MGC026

MGC026 is an investigational antibody-drug conjugate (ADC) targeting B7-H3, a protein with expression across the tumor microenvironment, including on tumor cells, tumor-associated stroma, and tumor-associated vasculature. MGC026 incorporates Synaffix’s proprietary ADC technology and the SYNtecan™ topoisomerase I inhibitor-based linker-payload, which consists of a cleavable, exatecan-based cytotoxic payload conjugated at a drug-to-antibody ratio (DAR) of 4. The ongoing Phase 1 study of MGC026 is an open-label clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of MGC026 in patients with advanced solid tumors. The study is currently evaluating patients with SCCHN, endometrial cancer, melanoma, and soft tissue sarcoma. Additional information about the study is available at www.clinicaltrials.gov using the identifier NCT06242470.

About MacroGenics, Inc.

MacroGenics (the Company) is a biopharmaceutical company focused on developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, expected timing of the release of clinical updates and safety and efficacy data for the Company’s ongoing clinical trials, anticipated cash runway and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy, including our ability to execute on our key strategic priorities for 2026, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks related to the reproducibility of any results initially seen in any product candidate including the results for MGC026 discussed herein; risks that any product candidate’s revenue, expenses and costs may not be as expected; risks relating to any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates for MGC026 or any other product candidates, including timing and results of efficacy and safety data with respect to MGC026 or any other product candidates in ongoing clinical trials; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations regarding the expansion of ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company’s product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; risks related to the transition of the CDMO operations to the purchaser following the sale of our CDMO operations; and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

CONTACT: CONTACTS
Jim Karrels, Senior Vice President, CFO
1-301-251-5172
info@macrogenics.com

Argot Partners
1-212-600-1902
macrogenics@argotpartners.com

— Prolonged Stable Disease: PAS-004 achieved prolonged stable disease in a heavily pre-treated population, with four patients on PAS-004 for more than 300 days, including two who continue on once daily PAS-004 for over 500 days despite recurrent, metastatic melanoma carrying the BRAF V600E mutation and prior progression on targeted combination therapy with dabrafenib and trametinib.

— Long-Term Tolerability: Overall, the safety profile of PAS-004 in the heavily pre-treated advanced cancer population appears favorable. No Grade 3 treatment-related adverse events (“AEs”), no discontinuations due to treatment-related AEs, and no related serious AEs have been reported. Treatment-related AEs remain low-grade and manageable, with low rates of vomiting, nausea, diarrhea, and rash, including none reported by the four patients on-study for >300 days. None of the MEKi class effects on the heart or the retina have been reported. To date, there have been no dose-limiting toxicities, and the maximum tolerated dose has not been reached.

— Favorable Pharmacokinetic Profile: PAS-004 demonstrated a long half-life, approximately 58 hours on average, with a low Cmax/Cmin ratio of less than 1.5. AUC increased proportionally in this dose escalation study. The flat pharmacokinetic curve with a long half-life supports long-term, chronic dosing.

MIAMI, Oct. 23, 2026 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, today announced updated safety, tolerability, and preliminary efficacy data from its ongoing Phase 1 dose-escalation study of PAS-004 monotherapy in a heavily pre-treated population of patients with MAPK pathway-driven advanced solid tumors harboring RAS, NF1 or RAF mutations, including patients who have failed prior BRAF/MEK inhibitor treatment (NCT06299839). The data, reflecting durable clinical benefit, including prolonged stable disease in four patients, as well as long-term tolerability and flat pharmacokinetics, are being presented today at the ESMO Congress 2026, taking place October 23-27, 2026, in Madrid, Spain.

“The prolonged stable disease that we’re seeing in some patients across this heavily pre-treated population is highly encouraging, particularly in patients with BRAF V600E-mutant tumors who previously progressed on BRAFi monotherapy and/or BRAFi/MEKi combination therapy. The literature reports a median progression-free survival of approximately five months for combination BRAFi/MEKi rechallenge in this setting, and some patients in the BRAF-mutant subgroup are exceeding that benchmark with our MEKi monotherapy,” said Dr. Kartik Krishnan, Chief Medical Officer of Pasithea. “What makes this data especially encouraging is that we’re seeing these signals of durable clinical benefit alongside a long-term tolerability profile that continues to hold up. No patient has discontinued treatment at any dose level due to treatment-related adverse events, and we continue to observe low rates of vomiting and other GI toxicity, low rates of rash, even in patients taking PAS-004 continuously for long periods of time. A tolerability profile like this is exactly what you want to see for the long-term treatment of chronic diseases including neurofibromatosis type 1 (NF1).”

Details of the Presentation:

Title: Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of PAS-004, a Macrocyclic MEK Inhibitor, for the Treatment of Patients with MAPK Pathway Driven Advanced Solid Tumors

Abstract/Poster Number: 1050P

Session: Developmental Therapeutics

Date/Time: Friday, October 23, 2026, 15:15–16:00 CEST

Key Findings (Data as of 15 September 2026):

Enrollment: 37 patients enrolled in dose escalation across 10 dose cohorts (2mg, 4mg, 8mg, 15mg, 22mg, 30mg, 37mg and 45mg capsule formulations, and 4mg and 18mg tablet formulations).

Patient Population: Heavily pre-treated population with a median of 3 prior lines of therapy (range 1–8); median age 57 years; 54.1% (n=20) female; most common tumor types were colorectal (38%, n=14), melanoma (30%, n=11) and pancreatic (16%, n=6).

BRAF-Mutant Patients: 12 patients enrolled with BRAF V600E mutations, 10 of whom previously progressed on BRAF and/or BRAF/MEK combination therapy.

Prolonged Stable Disease: Four patients have been on PAS-004 for greater than 300 days; two patients remain on treatment for more than 500 days with prolonged stable disease.

Safety: No dose limiting toxicities were observed. No patient has discontinued PAS-004 due to treatment-related adverse events (TRAEs). No grade ≥3 were observed. TRAEs reported in 45.9% (17 of 37) of patients; all Grade 1 or 2. Most common TRAEs: nausea (14%), vomiting (11%), rash (11%), blood creatine phosphokinase increased (11%) and diarrhea (5%). Cumulative rates of rash and gastrointestinal toxicities have remained low across all patients at all doses, with no MEKi-associated toxicities on cardiac function or retina observed to date. The maximum tolerated dose (MTD) has not been reached.

Pharmacokinetics: Linear PK with an estimated half-life of ~58 hours and a flat Cmax/Cmin ratio below 1.5 at steady state, supporting long term, once-daily (QD) dosing.

About Pasithea Therapeutics Corp.

Pasithea is a clinical-stage biotechnology company primarily focused on the research and development of its lead drug candidate, PAS-004, a next-generation macrocyclic MEK inhibitor intended for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases. The Company is currently testing PAS-004 in a Phase 1 clinical trial in advanced cancer patients (NCT06299839), and a Phase 1/1b clinical trial in adult patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (NCT06961565).

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company’s clinical data from its ongoing Phase 1 dose-escalation study of PAS-004 in advanced solid tumors, , the Company’s ongoing Phase 1/1b clinical trial of PAS-004 in adult NF1 patients, and the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company’s current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company’s plans, assumptions, expectations, beliefs and objectives, the success of the Company’s current and future business strategies, product development, pre-clinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth and financing opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Contact

Patrick Gaynes
Investor Relations
pgaynes@pasithea.com

  • Initial and updated cohort data from ongoing Phase 1/2 study of highly selective non-brain-penetrant PARP1 inhibitor EIK1003 continue to support potentially differentiated profile of EIK1003 in combination strategies within the PARP inhibitor landscape
  • Initial results from ongoing Phase 1/2 study of highly selective CNS-penetrant PARP1 inhibitor EIK1004 demonstrate a generally well-tolerated safety profile across multiple dose levels, with minimal Grade 3 or higher hematologic toxicities as of the safety data cutoff
  • Preliminary data for Werner (WRN) helicase inhibitor EIK1005 support continued development as monotherapy and in combination with pembrolizumab, with pharmacokinetic (PK) profile supporting weekly administration
  • Additional data from PARP1-selective and WRN helicase programs expected in 2027

MILLBRAE, Calif., Oct. 23, 2026 (GLOBE NEWSWIRE) — Eikon Therapeutics, Inc. (Nasdaq: EIKN) (“Eikon”), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, today announced the presentation of initial and updated data for EIK1003 and initial data for EIK1004 and EIK1005 at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain.

“These data strengthen the foundation of our clinical-stage pipeline, with encouraging evidence of activity and tolerability across our selective PARP1 programs,” said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon. “The EIK1003 results support continued development both as monotherapy and in combination with established cancer treatments, while the initial EIK1004 findings support further evaluation of our CNS-penetrant PARP1 inhibitor. The first clinical results for EIK1005, our internally derived WRN helicase inhibitor, mark an important step in translating Eikon’s discovery science into potential new medicines for patients.”

EIK1003 Clinical Update:

Updated data from EIK1003-001 demonstrate that highly selective non-brain-penetrant PARP1 inhibitor EIK1003 as monotherapy (Cohort 1A) was generally well-tolerated across multiple dose levels. In Cohort 1B, EIK1003 in combination with the novel hormonal agent abiraterone is observed to have a favorable tolerability profile with preliminary signs of clinical activity. In Cohort 1C, signals of antitumor activity were observed with EIK1003 in combination with weekly paclitaxel, with a combination safety profile consistent with paclitaxel’s known toxicities. These data support a potentially unique profile for EIK1003 in combination strategies within the evolving PARP inhibitor landscape.

Cohort 1A: Updated EIK1003 monotherapy data

As of the July 13, 2026, safety data cutoff, 65 participants with breast, ovarian, prostate, or pancreatic cancer with tumors harboring deleterious or suspected deleterious germline or somatic mutations in homologous recombination repair (HRR) genes have been treated in Cohort 1A with EIK1003 monotherapy at doses ranging from 10 mg to 160 mg once daily (QD), using a Bayesian optimal interval dose-escalation design to assess safety, tolerability, pharmacokinetics and antitumor activity. This represents an expansion of the dataset previously presented at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO), with longer follow-up.

The updated safety profile in Cohort 1A has remained generally consistent with data previously presented at ASCO 2026. Treatment-emergent adverse events (TEAEs) were reported in 63 of 65 participants (96.9%). Grade 3 or higher TEAEs occurred in 28 participants (43.1%); the most common were anemia (9.2%, 6/65), neutropenia (7.7%, 5/65), ascites (6.2%, 4/65), and thrombocytopenia (3.1%, 2/65). 4 of the 6 participants who developed Grade 3 or higher anemia had Grade 1-2 anemia at baseline. TEAEs led to dose interruptions in 22 participants (33.8%), reductions in 7 participants (10.8%) and treatment discontinuation in 4 participants (6.2%). No treatment-related adverse events (TRAEs) leading to death were reported.

Among efficacy-evaluable participants in Cohort 1A (n=49), objective response rate (ORR) was 14.3% (7/49) overall, consisting of 5 confirmed partial responses (PR) and 2 unconfirmed PRs. ORR was 31.3% (5/16) in PARP-naïve participants, and 6.1% (2/33) in participants previously treated with a PARP inhibitor. Objective responses by tumor type were 14.8% (4/27) in ovarian cancer, 12.5% (2/16) in breast cancer, and one participant (1/1) with prostate cancer. The disease control rate (DCR) for the cohort was 38.8% (19/49), clinical benefit rate (CBR) was 22.4% (11/49) for ≥18 weeks, and the median duration of response (DOR) among confirmed responders (n=5) was 6.3 months at the efficacy data cutoff of October 1, 2026.

Cohort 1B: Initial data on EIK1003 in combination with the novel hormonal agent abiraterone in metastatic prostate cancer

As of the July 13, 2026, safety data cutoff, 40 participants with metastatic prostate cancer, including mCRPC or mCSPC with tumors harboring deleterious or suspected deleterious germline or somatic mutations in HRR genes, have been treated with EIK1003 at doses ranging from 10 mg to 60 mg QD using a Bayesian optimal interval dose-escalation design to assess safety, tolerability, pharmacokinetics and antitumor activity in combination with abiraterone at 1000 mg QD and prednisone at 5 mg once daily or twice daily, with or without androgen deprivation therapy depending on their sensitivity status. TEAEs were reported in 95.0% (38/40) of participants, with the most common being anemia, fatigue and nausea, each occurring in 30.0% (12/40) of participants. Grade 3 or higher TEAEs were reported in 45.0% (18/40) of participants, the most common being anemia (15.0%, 6/40), infection (7.5%, 3/40), thrombocytopenia (7.5%, 3/40) and hematuria (5.0%, 2/40). All participants who developed Grade 3 or higher anemia had Grade 1-2 anemia at baseline. Among the 40 participants in the study, transfusion support was required in the 6 (15.0%) who entered the study with Grade 1-2 anemia and was mandated by protocol for anyone developing Grade 3 or higher anemia. There were no TRAEs that led to death. Dose interruptions due to a TEAE occurred in 16 (40.0%) participants for EIK1003, and 15 (37.5%) for abiraterone; dose reduction due to a TEAE occurred in 1 (2.5%) participant for EIK1003, with no dose reductions reported for abiraterone; and discontinuation due to a TEAE occurred in 5 (12.5%) participants each for EIK1003 and abiraterone.

Among the 24 efficacy-evaluable participants per RECIST v1.1 at the efficacy data cutoff date of October 3, 2026, ORR was 20.8% (5/24) with a total of 3 confirmed and 2 unconfirmed PRs. Among participants with mCRPC, the ORR was 19.0% (4/21) and for mCSPC the ORR was 33.3% (1/3). Median DOR in confirmed responders was 5.5 months for mCRPC and 4.8 months for mCSPC. The DCR was 83.3% (20/24) and the CBR ≥18 weeks was 58.3% (14/24). Among the 39 participants who were efficacy-evaluable per Prostate Cancer Clinical Trials Working Group 3 (PCWG3), 87.2% (34/39) had mCRPC and 12.8% (5/39) had mCSPC. PSA response (≥50% reduction from baseline) was observed in 30.8% (12/39) of PSA-evaluable participants overall, 26.5% (9/34) of mCRPC participants and 60.0% (3/5) of mCSPC participants responding.

Cohort 1C: Updated data on EIK1003 in combination with weekly paclitaxel in ovarian and breast cancers

As of the July 13, 2026, safety data cutoff, 61 participants with platinum-resistant ovarian cancer or HER2-negative breast cancer that failed chemotherapy or hormonal therapy have been treated in Cohort 1C with EIK1003 at doses ranging from 10 mg to 60 mg QD in combination with paclitaxel 80 mg/m2 IV QW. Dose-limiting toxicities of febrile neutropenia and tachycardia were reported in one participant each at the highest dose level tested, 60 mg. TEAEs were reported in 61 participants (100%). Grade 3 or higher TEAEs occurred in 49 participants (80.3%); the most common were neutropenia (49.2%, 30/61) and anemia (18.0%, 11/61). Neutropenia is a known and expected adverse event associated with weekly paclitaxel chemotherapy. 9 out of 11 participants who developed Grade 3 or higher anemia had Grade 1-2 anemia at baseline. TEAEs led to dose interruption in 53 participants (86.9%), reductions in 20 participants (32.8%), and discontinuation of one or both study drugs in 17 participants (27.9%). No TRAEs leading to death were reported. Median relative dose intensity was 89.1% for EIK1003 and 60.0% for paclitaxel in Cohort 1C, with lower paclitaxel intensities reflective of protocol-driven holds for anticipated neutropenia; EIK1003 was not dose-limiting.

Among the 53 efficacy-evaluable participants per RECIST v1.1 in Cohort 1C, ORR was 26.4% (14/53) with 1 confirmed complete response (CR) and 13 PRs (9 confirmed); 12 of 14 responders (86%) had received prior taxane therapy. Objective responses by tumor type were 29.6% (8/27) in platinum-resistant ovarian cancer and 23.1% (6/26) in breast cancer. Duration of response among confirmed responders ranged from 1.7 to 11.4 months, with responses ongoing in 2 confirmed responders at the efficacy data cutoff of October 1, 2026. The DCR for Cohort 1C was 79.2% (42/53), and CBR was 37.7% (20/53) for ≥18 weeks.

Eikon is currently enrolling an additional Cohort 1D evaluating EIK1003 in combination with paclitaxel and platinum-based chemotherapy, for which initial results are expected in the second half of 2027. Eikon also expects to complete the ongoing Phase 2 dose optimization portion of the trial in the second half of 2027.

Initial EIK1004 Clinical Data:

Initial data from EIK1004-001, Eikon’s Phase 1/2 trial evaluating the safety and efficacy of CNS-penetrant PARP1-selective inhibitor EIK1004 as monotherapy in participants with advanced solid tumors harboring deleterious or suspected deleterious germline or somatic mutations in HRR genes, demonstrate minimal hematological suppression at the dose levels studied, consistent with EIK1004’s highly selective PARP1 profile.

As of the July 13, 2026, safety data cutoff, 68 participants had been treated with EIK1004 monotherapy. EIK1004 was observed to be generally well-tolerated across multiple dose levels with no treatment-emergent dose-limiting toxicities (DLTs) reported, with the majority of TEAEs being low grade. Grade 3 or higher TEAEs were reported in 12 (17.6%) participants and included findings of abdominal pain, fatigue and nausea, each reported in 2 (2.9%) of participants. Grade 3 or higher TEAEs of anemia and neutropenia occurred at only 1.5% (1/68) each, and no Grade 3 or higher TEAEs of thrombocytopenia were observed. No TEAE led to death, and TEAEs leading to dose reductions (1/68) and/or discontinuations (0/68) were rare.

Out of the 68 participants who received EIK1004, 58 were efficacy evaluable with at least 1 post-baseline assessment for tumor response per RECIST v1.1 as of the October 1, 2026, efficacy data cutoff. The observed ORR was 12.1% (7/58) and the DCR was 62.1% (36/58): 71.4% (20/28) in PARP-naïve participants and 53.3% (16/30) in those previously treated with a PARP inhibitor. There was 1 confirmed CR in a breast cancer participant and 6 PRs (2 confirmed and 4 unconfirmed), with responses seen across breast (1 CR, 2 PR), ovarian (2 PR) and prostate (2 PR) cancers. ORRs by tumor type were 11.1% (3/27), 14.3% (2/14) and 50% (2/4) for breast, ovarian and prostate, respectively. There were no responses in participants with pancreatic cancer.

Eikon plans to initiate a combination arm of EIK1004-001 evaluating EIK1004 in combination with docetaxel, with plans to report initial results from that combination arm in the second half of 2027.

Preliminary EIK1005 Clinical Data:

Preliminary data were presented from EIK1005-002, an ongoing Phase 1/2 trial evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of Werner (WRN) helicase inhibitor EIK1005 as monotherapy or in combination with pembrolizumab for the treatment of advanced solid tumors, including those harboring DNA mismatch repair deficiency (dMMR) or microsatellite instability (MSI-H).

As of the August 20, 2026, safety data cutoff, 10 participants have been dosed with 50-200 mg EIK1005 once-weekly (QW) in monotherapy dose escalation (Part 1A) and 1 participant was dosed with 50 mg EIK1005 (QW) and 200 mg pembrolizumab once every third week (Q3W) in combination dose escalation (Part 1B). For EIK1005 as monotherapy, no dose-limiting toxicities (DLTs) were reported at doses of 50 mg, 100 mg, and 200 mg administered weekly. TEAEs were reported in 90% (9/10) of participants, and the majority were Grade 1-2, none were Grade 4 or higher and there were no fatal adverse events. TRAEs were reported in 40% (4/10) of participants and all TRAEs were Grade 1-2. For EIK1005 in combination with pembrolizumab, the single participant has not experienced a DLT and all TEAEs were Grade 1-2 and included nausea, pyrexia, rash and constipation.

As of the October 1, 2026, efficacy data cutoff, 6 out of 8 participants (75%) in Part 1A who had at least one post-baseline tumor assessment have reported a best response of stable disease (SD) by investigator-based assessment. One participant at the lowest dose level has had SD for over 8 months with response ongoing. All 6 of these participants with SD have confirmed MSI-H/dMMR tumors. As of October 1, 2026, the participant enrolled in Part 1B remained on treatment in Cycle 4. This participant has MSI-H/dMMR disease and has achieved a PR at the first post-baseline scan, as assessed by the investigator.

EIK1005 PK was well characterized across the evaluated dose range in both healthy participants in the EIK1005-001 study and in participants with advanced solid tumors in the EIK1005-002 trial, with exposure increasing with dose. Terminal elimination half-life (T1/2) was approximately 9.4 days following a 100 mg EIK1005 dose, supporting weekly dosing.

Eikon expects additional results from the combination of EIK1005 with pembrolizumab to be available in the first half of 2027, with complete results for EIK1005 monotherapy available in the second half of 2027.

About Eikon Therapeutics
Eikon is a late-stage clinical biopharmaceutical company dedicated to building a global, fully integrated organization developing innovative medicines to address serious unmet medical needs. Eikon’s initial focus is oncology, where it is advancing a pipeline of drug candidates targeting areas of high unmet need that could eventually become critical medicines for the treatment of various cancers. Eikon deploys its technology platform, including its proprietary single molecule tracking system, to develop internally derived novel therapies, while also leveraging the deep expertise of its management team to in-license promising assets. Eikon’s vision is to become a generational leader, by purposefully integrating traditional biology research with advanced engineering to develop better medicines faster. For more information, visit www.eikontx.com.

About EIK1003 (Selective PARP1 Inhibitor)
EIK1003 (previously known as IMP1734) is an investigational, highly selective PARP1 inhibitor designed to leave PARP2 signaling intact. PARP2 inhibition may be a key driver of the hematologic toxicity associated with first-generation, non-selective PARP inhibitors. EIK1003-001 (NCT06253130) is a global, first-in-human, Phase 1/2, open-label, multi-center, multi-part dose-escalation, dose-optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of EIK1003 as monotherapy and in combination with standard of care regimens in participants with advanced solid tumors. The study comprises 3 parts: Part 1 (FIH; Dose Escalation), Part 2 (Dose Optimization), and Part 3 (Dose Expansion at the recommended dose for expansion).

About EIK1004 (CNS-Penetrant Selective PARP1 Inhibitor)
EIK1004 (previously known as IMP1707) is a highly potent and selective PARP1 inhibitor. EIK1004 is CNS-penetrant and has demonstrated tumor growth inhibition in preclinical models of brain metastases. EIK1004-001 (NCT06907043) is a first-in-human global Phase 1/2 open-label, multi-center study evaluating safety, tolerability, and potential antitumor activity of EIK1004 monotherapy in participants with advanced ovarian, breast, prostate, or pancreatic cancer, with or without brain metastases.

About EIK1005 (WRN Helicase Inhibitor)
EIK1005 is a novel, potent, and selective WRN inhibitor with the potential for targeted antitumor activity in MSI-H or dMMR solid tumors. The molecule emerged through application of Eikon’s advanced imaging discovery platform. EIK1005-002 (NCT07262619) is a global, multicenter, multi-part, Phase 1/2 study of EIK1005 monotherapy, and in combination with pembrolizumab, in participants with advanced solid tumors, including MSI-H and dMMR tumors.

Forward-Looking/Safe Harbor Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical facts are hereby identified as forward-looking statements for this purpose. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the therapeutic potential, safety, and efficacy of Eikon’s product candidates; the potential to further develop Eikon’s product candidates; the timing for anticipated data readouts; expected milestones and business objectives, including Eikon’s anticipated presentations at the 2026 ESMO Congress; and other statements regarding Eikon’s future operations, financial performance, financial position, prospects, objectives, strategies and other future events.

These forward-looking statements are based upon management’s current expectations and assumptions, and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: our limited operating history; our significant net losses incurred since inception and the likelihood of incurring additional losses for the foreseeable future; our need for substantial additional funding; the early stage of development of many of our product candidates and the possibility that our product candidates may fail in development; our dependence on the success of our current product candidates; our ability to leverage our technology platform to enable more informed drug research and development; legal and regulatory risks; intellectual property-related risks; and those risks, uncertainties and other factors discussed under the caption “Risk Factors” and elsewhere in Eikon’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the Securities and Exchange Commission (“SEC”) on August 13, 2026, and in other public filings with the SEC in the future.

As a result, you should not place undue reliance on any forward-looking statements. The forward-looking statements made in this press release speak only as of the date of this press release, and Eikon undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by law.

Contacts:

Investors
Alfred “Freddie” Bowie, Ph.D., CFO
ir@eikontx.com

Media
Colin Sanford
colin@bioscribe.com

Median radiographic progression free survival (“rPFS”) was 15.7 months and the six-month rPFS rate (“rPFS6”) was 82.2% in patients who received prior abiraterone

Median rPFS was 9.1 months and rPFS6 was 62.5% in patients who received prior enzalutamide

The Phase 2 portion of the study evaluating gedatolisib plus darolutamide is expected to begin in the first half of 2027

MINNEAPOLIS, Oct. 23, 2026 (GLOBE NEWSWIRE) — Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced updated clinical results from the Phase 1b/2 study evaluating gedatolisib in patients with metastatic castration-resistant prostate cancer (“mCRPC”). These data were presented at the European Society of Medical Oncology (ESMO) Congress 2026 today, Friday, October 23, 2026, at 9:15 a.m. EDT/3:15 p.m. CEST at a poster presentation:

Poster 2237P: A phase 1/2, open-label, randomized, dose-finding and dose expansion study of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC)

In this Phase 1b/2 study, 45 patients with mCRPC were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg gedatolisib in Arm 1 (n=19), 180 mg gedatolisib in Arm 2 (n=19) and 240 mg gedatolisib in Arm 3 (n=7). In all arms, gedatolisib was administered intravenously on days 1, 8, and 15 of a 28-day cycle, then two weeks off. Additionally, all patients received prophylactic treatment for stomatitis. Baseline characteristics were generally consistent across dose cohorts; over 50% had bone disease, 33% had phosphatase and tensin hemolog (“PTEN”) loss. Data was analyzed as of an August 14, 2026 cut-off date.

Key results reported included:

  • Median rPFS was 15.7 months with an rPFS6 rate of 82.2% in patients with prior abiraterone exposure (n=22).
  • Median rPFS was 9.1 months with an rPFS6 rate of 62.5% in patients with prior enzalutamide exposure (n=18).
  • PSA ≥50% decreases from baseline (“PSA50”) were observed across all dose levels; response rates were 36%, 47% and 67% at the 120-, 180-, and 240-mg gedatolisib dose levels, respectively, in patients with prior exposure to either abiraterone or enzalutamide.
  • Exploratory analyses of patients according to their PTEN status suggest activity is independent of PTEN status.
  • Gedatolisib plus darolutamide demonstrated a manageable safety profile across the evaluated dose levels (120 mg, 180 mg, 240 mg) with one dose limiting toxicity (Grade 3 rash), no Grade 4/5 treatment related adverse events (“TRAEs”), and no TRAEs leading to treatment discontinuation or death. Grade 3 TRAEs occurred in 9 (20%) patients with only rash (n=4) and pruritus (n=2) occurring in more than one patient.

“We are highly encouraged by these results and believe combining gedatolisib with an androgen receptor inhibitor is a promising new approach for patients with mCRPC,” said Igor Gorbachevsky, Chief Medical Officer of Celcuity. “The 82.2% six-month PFS rate and median rPFS of 15.7 months is remarkable in patients who had received prior abiraterone and compares favorably to published data for AR inhibitors in this setting. We look forward to initiating the Phase 2 portion of the study and further evaluating this combination in more patients.”

The randomized Phase 2 study is expected to evaluate two different groups of patients (Groups 1 and 2) with the objective of determining the recommended phase 3 dose level. Subjects in Group 1 will be those who received prior abiraterone for either hormone sensitive or castration resistant prostate cancer. Subjects in Group 2 will be those who received prior enzalutamide or apalutamide for either hormone sensitive or castration resistant prostate cancer. Celcuity anticipates initiating this study in the first half of 2027 after completion of the Phase 1b part of the study.

About Prostate Cancer
Prostate cancer is the second most commonly occurring cancer in men with 1.5 million cases diagnosed in 2024 and the fourth most commonly occurring cancer overall worldwide.1 The American Cancer Society estimates approximately 333,830 men will be diagnosed with prostate cancer in 2026 and over 36,000 will die annually in the U.S.2 For men diagnosed with metastatic castration-resistant prostate cancer, the 5-year survival rate is 32% and there is a significant need for better treatment options, as median progression-free survival is currently between 6.7 – 5.5 months in the second line setting following AR therapy.3-5

About Celcuity

Celcuity is a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company’s first FDA-approved product is REVTORPYK™ (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM (PI3K/AKT/mTOR) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- locally advanced or metastatic breast cancer (“ABC”), supported U.S. Food and Drug Administration approval of REVTORPYK for use in patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the Company’s clinical strategy, including the benefits of strategic decisions regarding studies and trials; and other expectations with respect to gedatolisib, including potential future indications for gedatolisib regimens. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in the Company’s clinical trials; and the development of therapies and tools competitive with gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

References

  1. Sung H, Filho AM, Laversanne M, Ferlay J, Siegel RL, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2024: GLOBOCAN estimates of incidence and mortality worldwide for 34 cancers in 186 countries. CA Cancer J Clin. 2026 Jul-Aug;76(4):e70090. doi: 10.3322/caac.70090. PMID: 42417444; PMCID: PMC13343830.
  2. American Cancer Society website; Accessed October 2026: https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html
  3. Crabb, J Clin Oncol 2021
  4. Attard, J Clin Oncol 2018
  5. Sweeny Clin Cancer Res 2022

Contacts

For Investors: 
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com   
(763) 392-0123
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924

For Media:
Sam Brown LLC
Laura Morgan, lauramorgan@sambrown.com
(951) 333-9110

BEIJING, Oct. 23, 2026 (GLOBE NEWSWIRE) — KANZHUN LIMITED (“BOSS Zhipin” or the “Company”) (Nasdaq: BZ; HKEX: 2076), a leading online recruitment platform in China, today announced that Mr. Haiyang Yu (“Mr. Yu”) has tendered his resignation as a non-executive director of the Company due to his other business commitments, with effect from October 23, 2026.

The Company would like to take this opportunity to express its gratitude to Mr. Yu for his valuable contribution to the Company during his tenure of office.

Safe Harbor Statement

This press release contains statements that may constitute “forward-looking” statements which are made pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to,” and similar statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission, in announcements made on the website of The Stock Exchange of Hong Kong Limited, in its interim and annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including but not limited to statements about the Company’s beliefs, plans, and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. Further information regarding these and other risks is included in the Company’s filings with the U.S. Securities and Exchange Commission and The Stock Exchange of Hong Kong Limited. All information provided in this press release is as of the date of this press release, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

About KANZHUN LIMITED

KANZHUN LIMITED operates the leading online recruitment platform BOSS Zhipin in China. The Company connects job seekers and enterprise users in an efficient and seamless manner through its highly interactive mobile app, a transformative product that promotes two-way communication, focuses on intelligent recommendations, and creates new scenarios in the online recruiting process. Benefiting from its large and diverse user base, BOSS Zhipin has developed powerful network effects to deliver higher recruitment efficiency and drive rapid expansion.

For more information, please visit https://ir.zhipin.com.

For investor and media inquiries, please contact:

KANZHUN LIMITED
Investor Relations
Email: ir@kanzhun.com 

PIACENTE FINANCIAL COMMUNICATIONS
Email: kanzhun@tpg-ir.com 

  • Transactions position the company to advance Prana’s pipeline of next-generation, half-life-extended multispecific antibodies enabled by its proprietary INSPIRE platform
  • PRA-216 is a novel IL-4Rα/TSLP bispecific antibody currently in Phase 2 development for asthma, COPD, and atopic dermatitis, with a Phase 2 study in EoE planned; patient data from all four trials expected beginning in the second quarter of 2027
  • Concurrent private placement of $120 million in upfront financing with the potential to receive up to an additional $60 million upon exercise of accompanying warrants secured from leading healthcare institutional investors is expected to fund operations into 2028
  • Following the transaction, Sheila Gujrathi, M.D., Prana’s Co-Founder and former Chief Executive Officer, will join Bolt’s executive team and Bolt’s Board of Directors
  • Bolt to host conference call and webcast on October 26, 2026 at 8:30 a.m. ET

REDWOOD CITY, Calif., Oct. 23, 2026 (GLOBE NEWSWIRE) — Bolt Biotherapeutics, Inc. (Nasdaq: BOLT) (“Bolt” or the “Company”) today announced the acquisition of Prana Therapies, Inc. (“Prana”), a clinical-stage biotechnology company pioneering next-generation half-life-extended multispecific antibodies designed to deliver best-in-disease therapies. Following the acquisition, the Company will focus on advancing Prana’s pipeline of half-life-extended multispecific antibodies generated from its proprietary INSPIRE platform, led by PRA-216, a novel IL-4Rα/TSLP bispecific antibody currently in Phase 2 development in asthma, chronic obstructive pulmonary disease (COPD) and atopic dermatitis, with a Phase 2 study in eosinophilic esophagitis (EoE) planned.

The acquisition was structured as a sign-and-close reverse merger, in which the parties entered into a merger agreement for a stock-for-stock transaction. Concurrent with the acquisition, Bolt entered into a securities purchase agreement for a private placement financing, which includes $120 million in upfront gross proceeds for the purchase of shares of Series D non-voting convertible preferred stock and up to an additional $60 million upon exercise of accompanying warrants with a syndicate of new and existing leading healthcare institutional investors, including Deep Track Capital, ADAR1 Capital, Andreessen Horowitz (a16z), LYFE Capital, Coastlands Capital, Eventide Asset Management, Casdin Capital, Curie.Bio, SilverArc Capital, Soleus Capital, Deviation Capital and other institutional investors. The proceeds from the private placement are expected to fund operations into 2028 and through multiple anticipated clinical and preclinical milestones.

“We built the INSPIRE platform to realize the potential of multispecific antibodies as medicines, combining complementary biology with the properties needed to deliver both greater efficacy and a better treatment experience for patients. PRA-216 is our flagship program, designed for best-in-disease efficacy together with the convenience of infrequent, at-home dosing,” said Sheila Gujrathi, M.D., Co-Founder and former Chief Executive Officer of Prana, and newly appointed Chief Strategy Officer. “This transaction and financing provide the resources to advance PRA-216 through multiple Phase 2 readouts in 2027 while continuing to expand our INSPIRE pipeline. We are grateful for the support of our new and existing investors as we enter this next stage of development.”

“We believe the acquisition of Prana provides a compelling opportunity for Bolt stockholders to participate in the potential of a differentiated, clinical-stage pipeline addressing large markets, beginning in inflammatory disease,” said Willie Quinn, Chief Executive Officer of Bolt Biotherapeutics. “We have been impressed by Prana’s team, the clinical profile demonstrated by PRA-216 to date, and the broader potential of the INSPIRE platform. We look forward to the opportunities ahead for the company.”

Prana’s Pipeline Overview and Development Milestones

Prana’s focus is to develop the next generation of half-life-extended multispecific antibodies designed to deliver best-in-disease therapies. The lead program, PRA-216, is a fully human, half-life-extended bispecific antibody targeting IL-4Rα and TSLP and is the first clinical program generated from Prana’s proprietary INSPIRE platform. PRA-216 combines broad downstream blockade of both IL-4 and IL-13 signaling (through IL-4Rα blockade) with upstream TSLP inhibition to address complementary drivers of inflammation.

Prana disclosed data from the Phase 1 healthy volunteer study of PRA-216 as a late-breaking abstract at the 2026 European Respiratory Society. PRA-216 was well tolerated and demonstrated rapid, deep, and durable pharmacodynamic activity across multiple key Type 2 inflammatory biomarkers including pSTAT6, serum TARC, blood eosinophils, and IgE. PRA-216 also demonstrated bioavailability and extended exposure supporting the potential for convenient, at-home maintenance dosing every eight to 12 weeks. Phase 2 development in asthma, COPD, and atopic dermatitis has been initiated, with a Phase 2 study in EoE planned, and with patient data from all four trials expected beginning in the second quarter of 2027 and continuing through the fourth quarter of 2027.

PRA-216 provides the first clinical validation of Prana’s INSPIRE platform. INSPIRE continues to generate a pipeline of half-life-extended, fully IgG-based multispecific antibodies designed to overcome key limitations of conventional multispecific formats, including challenges with half-life, stability, manufacturability, immunogenicity, and subcutaneous delivery.

Prana’s second program is an IL-31 containing bispecific antibody being developed initially for atopic dermatitis. First-in-human studies in healthy volunteers and patients are expected to begin in the second half of 2027, with clinical data also expected in the second half of 2027.

Two additional undisclosed pipeline programs are expected to advance toward IND-enabling development by the second half of 2027.

About the Transactions

The acquisition was structured as a stock-for-stock transaction via sign-and-close reverse merger, pursuant to which all outstanding equity interests of Prana were exchanged based on a fixed exchange ratio for a combination of 430,746 shares of Bolt common stock and 16,360.929 shares of Series D non-voting convertible preferred stock (representing 16,791,675 shares of Bolt common stock on an as-converted-to-common basis and without giving effect to any beneficial ownership limitations).

Concurrent with the acquisition, Bolt entered into a definitive agreement for a private placement financing to raise $120 million in gross proceeds, for the purchase of 13,995.311 shares of Series D non-voting convertible preferred stock (or 13,995,311 shares of Bolt common stock on an as-converted-to-common basis and without giving effect to any beneficial ownership limitations) at a price of $8,574.30 per share (or $8.5743 per share on an as-converted basis) and up to an additional $60 million upon exercise of accompanying warrants to purchase up to 6,997,655 shares of common stock (or shares of Series D non-voting convertible preferred stock under certain circumstances), in each case at an exercise price of $8,574.30 per Series D share (or $8.5743 per share on an as-converted basis), in each case as described below. The private placement is expected to close on October 26, 2026.

Subject to Bolt stockholder approval in accordance with Nasdaq listing rules, each share of Series D non-voting convertible preferred stock will automatically convert into 1,000 shares of Bolt common stock, subject to certain beneficial ownership limitations set by each holder, and after conversion, each warrant will then become exercisable for shares of common stock, subject to certain beneficial ownership limitations set by each holder.

The acquisition was approved by the Board of Directors of Bolt and the Board of Directors and stockholders of Prana. The closings of the acquisition and the private placement were not subject to the approval of Bolt’s stockholders. The approval of Bolt’s stockholders is required, among other things, under the terms of the Series D non-voting convertible preferred stock in order for the Series D non-voting convertible preferred stock to be converted into shares of Bolt’s common stock, and Bolt is required to hold a stockholder meeting for such vote. The warrants issuable upon closing of the private placement will become exercisable for cash to purchase shares of common stock upon the automatic conversion of the Series D non-voting convertible preferred stock into common stock following receipt of the requisite stockholder approval (or shares of Series D non-voting convertible preferred stock under certain circumstances), at the applicable exercise price specified therein. The warrants will expire on the earlier of (i) 30 days following the company’s first public disclosure of top-line results from the first-in-human clinical data from its Program 2 Phase 1 (IL-31 bispecific), such disclosure to include at least two dosing cohorts from subjects administered subcutaneous single ascending doses (n = approximately 8 per group) with at least 8 weeks post-dose follow up, similar to Phase 1 data previously generated for PRA-216 and (ii) June 30, 2028.

As a result of the transactions, equity holders of Bolt immediately prior to the acquisition will own approximately 6.9% of Bolt’s common stock, equity holders of Prana immediately prior to the acquisition will own approximately 51.7% of Bolt common stock and investors in the private placement financing will own approximately 41.4% of Bolt common stock, in each case, calculated on a fully-diluted basis (without giving effect to any beneficial ownership limitations and assuming the conversion in full of the Series D non-voting convertible preferred stock into common stock) using the treasury stock method and based on the implied equity values of Bolt and Prana. On an as-converted basis and after accounting for these transactions (and without giving effect to any beneficial ownership limitations), the total number of shares of Bolt common stock (including shares underlying the Series D non-voting convertible preferred stock) will be approximately 34,183,982.

Following receipt of the $120 million in upfront gross proceeds from the private placement, Bolt is expected to have projected cash runway into 2028.

Management and Board of Directors

In connection with the closing of the merger, Sheila Gujrathi, M.D., Prana’s Co-Founder and former Chief Executive Officer, has been appointed Chief Strategy Officer of Bolt and has joined the Bolt Board of Directors.

Advisory and Legal Counsel

Jefferies LLC, TD Cowen, Stifel, and LifeSci Capital are serving as placement agents for the concurrent private placement financing. Tungsten Advisors is also serving as financial advisor and placement agent to Prana. Cooley LLP is serving as legal counsel to Prana. Sidley Austin LLP is serving as legal counsel to Bolt. Lake Street Capital Markets provided a fairness opinion to Bolt’s Board of Directors. Gibson, Dunn & Crutcher LLP is serving as legal counsel to the placement agents.

Conference Call and Webcast

Bolt will host a conference call and webcast on Monday, October 26, 2026 at 8:30 a.m. ET to discuss the transaction, financing, and the company’s pipeline.

To listen to the live webcast, or access the archived webcast and accompanying presentation, please visit: https://investors.boltbio.com/news-and-events/events-and-presentations. Following the live webcast, a replay will be available on Bolt’s website.

About Bolt Biotherapeutics, Inc.

Bolt Biotherapeutics is a clinical-stage biotechnology company pioneering a new generation of half-life-extended multispecific antibodies designed to deliver best-in-disease therapies. Through the proprietary INSPIRE platform it acquired from Prana Therapies, the company combines complementary therapeutic mechanisms in fully IgG-based molecules designed for differentiated efficacy, extended exposure, and convenient dosing.

The company’s lead program, PRA-216, is a novel IL-4Rα/TSLP bispecific antibody currently in Phase 2 development in asthma, chronic obstructive pulmonary disease, and atopic dermatitis, with a fourth Phase 2 study planned in eosinophilic esophagitis. In addition to PRA-216, Bolt Biotherapeutics is advancing a wholly owned pipeline of additional INSPIRE-based multispecific programs across diseases with significant unmet need.

For more information, please visit https://www.boltbio.com/.

Forward-Looking Statements

This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including, without limitation, statements regarding Bolt, Prana, the concurrent private placement financing and the acquisition of Prana by Bolt (the “Transactions”) and other matters, including, without limitation, statements regarding: the Transactions, including the closing of the concurrent private placement financing, including any additional gross proceeds that may be received upon exercise, if any, of accompanying warrants, if any, and the expected effects, perceived benefits or opportunities and related timing with respect thereto; expectations regarding or plans for the company’s pipeline, including its ongoing and planned clinical trials, research and development programs and the expected timing for key milestones, including the release of clinical data; the potential benefits of PRA-216 and Prana’s other clinical programs; and expectations regarding the use of proceeds from the concurrent private placement financing and cash runway expectations therefrom, including such proceeds funding the company through key clinical milestones; and any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “will,” or “would,” or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the company’s ability to consummate the private placement financing or realize the anticipated benefits from the transactions, including as a result of its failure to receive the requisite stockholder approvals; investors in the private placement may not exercise their warrants and the company may not receive any additional proceeds therefrom; the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized; and our ability to maintain our current collaborations and establish further collaborations. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC’s website at www.sec.gov.

Contacts

Christina Trout
VP, Corporate Development
investors@pranatherapies.com

Matthew DeYoung
Argot Partners
(212) 600-1902
boltbio@argotpartners.com

Preliminary cash, including short-term deposits, of approximately $11.0 million as of September 30, 2026, and total liabilities of approximately $2.5 million

Interim CEO Efraim Cohen-Arazi details LayerBio’s plans to enroll patients in the U.S. multi-center Phase 2 trial of OcuRing™-K before year-end and GridFeed’s strategic growth initiatives

TEL AVIV, Israel, Oct. 23, 2026 (GLOBE NEWSWIRE) — PRF Technologies Ltd. (Nasdaq: PRFX) (“PRF”, “PRF Technologies” or the “Company”) today issued a Letter to Shareholders from Efraim Cohen-Arazi, Interim Chief Executive Officer.

Nine Months 2026 and Recent Highlights

  • Consolidated cash, including short-term deposits, of approximately $11.0 million as of September 30, 2026, with total liabilities of approximately $2.5 million (preliminary and unaudited)
  • Raised approximately $10.5 million in gross proceeds through the Company’s equity line facility during the nine months ended September 30, 2026, including approximately $0.5 million in the third quarter
  • Consolidated operating loss of approximately $3.7 million for the nine months ended September 30, 2026 (preliminary and unaudited)
  • LayerBio under the IND for OcuRing™-K expects to begin enrolling patients in its U.S. multi-center Phase 2 clinical trial before year-end, following completion of trial preparatory activities
  • Announced plans to establish GridFeed™, together with the Company’s DeepSolar operations, as a standalone, wholly owned subsidiary to pursue various strategic transactions. Began evaluating AI and hyperscale data center power optimization as a new market for GridFeed, where the International Energy Agency (IEA) projects global data center electricity consumption to roughly double to 950 TWh by 2030

Dear Fellow Shareholders,

When we wrote to you in July, we shared that PRF had substantially strengthened its financial position and was building momentum across both of our businesses. We are pleased to report that we have continued to make progress since then. With a strengthened balance sheet, LayerBio is preparing to initiate its U.S. multi-center Phase 2 trial of OcuRing™-K, and we have taken important steps to build GridFeed™ into a standalone AI energy business with a new opportunity in data center power. Our focus over the coming months is on advancing LayerBio’s clinical program, developing GridFeed and maintaining financial discipline.

Strengthening Our Financial Foundation

During the nine months ended September 30, 2026, PRF raised approximately $10.5 million in gross proceeds through its equity line facility, including approximately $0.5 million in the third quarter. This financing strengthened our balance sheet and supports the development of our existing businesses and the evaluation of strategic growth opportunities.

Based on preliminary, unaudited consolidated management estimates:

  • Consolidated cash, including short-term deposits, as of September 30, 2026: approximately $11.0 million.
  • Total consolidated liabilities as of September 30, 2026: approximately $2.5 million.
  • Consolidated operating loss for the nine months ended September 30, 2026: approximately $3.7 million.

The consolidated financial results presented in this letter consists of cash, including short-term deposits, as of September 30, 2026; total liabilities as of September 30, 2026; and operating loss for the nine months ended September 30, 2026. It is preliminary and unaudited and is based on management’s preliminary estimates, using information available as of the date of this letter. The Company’s financial closing procedures for this period are not complete. This information does not constitute a complete set of financial statements, and is not necessarily indicative of results for the full year ending December 31, 2026 or any future period. The Company’s independent registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to this information and accordingly does not express an opinion or any other form of assurance on it. Final amounts may differ materially from these estimates as a result of the completion of financial closing procedures, final adjustments and other developments arising before the Company’s audited financial statements for the year ending December 31, 2026 are issued, which are expected to be included in the Company’s Annual Report on Form 20-F. The Company does not prepare or publish separate third-quarter financial statements. Except as required by law, the Company undertakes no obligation to update these preliminary estimates.

We believe this financial position allows us to focus on continued disciplined execution while keeping the flexibility to act on attractive opportunities as they arise.

Advancing OcuRing™-K Toward Phase 2

Our majority-owned subsidiary, LayerBio, Inc., under an Investigational New Drug (IND) approved for a Phase 2 trial of OcuRing™-K. LayerBio expects to start patient enrollment in the planned U.S. multi-center trial before year-end, following completion of trial start-up activities. The trial is designed to evaluate pain, inflammation and safety in patients undergoing cataract surgery for OcuRing™-K our extended release NSAID delivery device.

OcuRing™-K is a patent-protected, bio-erodible intraocular ring designed to deliver the anti-inflammatory drug ketorolac through a single application during surgery, providing sustained, localized drug release at the surgical site. Cataract surgery is one of the most commonly performed surgical procedures in the world, and post-operative care still relies largely on complex eye-drop regimens with well-documented compliance challenges. We believe OcuRing™-K has the potential to eliminate the need for those regimens and to make recovery easier for patients. Previously reported preclinical studies and a Phase 1 clinical evaluation demonstrated a favorable safety profile, with no treatment-related serious adverse events observed, and the Phase 2 trial is the next important step in the product’s development.

Our post-surgical pain candidate, PRF-110, has also generated encouraging data this year. In a head-to-head preclinical study, PRF-110 demonstrated sustained 72-hour analgesic activity comparable to an approved, commercially available extended-release product, using a ropivacaine-only, NSAID-free formulation, and expanded results from the same study showed slower systemic absorption and enhanced retention at the surgical site. With reducing reliance on opioids remaining a clinical and public health priority, we believe these results support the potential of our proprietary extended-release delivery platform.

Building GridFeed™ as a Standalone AI Energy Business

We continue to invest in GridFeed, our AI-driven platform for renewable energy trading and revenue optimization. GridFeed combines localized weather intelligence, production forecasting, battery storage orchestration and market analytics to support day-ahead, intraday and continuous trading decisions, with the goal of reducing imbalance exposure and maximizing revenue from solar, wind and battery storage assets. This year, the underlying engine was validated using real-world European utility-scale production, weather and market data, the platform was extended into battery energy storage through Battery-to-Revenue Intelligence, DeepSolar joined the NVIDIA Connect program and the Company began recognizing limited initial revenue from its first commercial engagements. PRF has also filed its first patent application related to GridFeed, covering plant-level microclimate forecasting technology designed to improve the accuracy of renewable energy forecasting.

In September, we announced plans to establish GridFeed, together with our DeepSolar operations, as a standalone, wholly owned subsidiary. This structure is intended to give us a clean vehicle to pursue strategic investment, partnerships and commercial collaborations directly at the GridFeed level with energy producers, traders, utilities, technology companies and sector-focused investors, and we believe it can help investors see the value of the GridFeed business more clearly.

We also announced that GridFeed is exploring AI and hyperscale data centers as a new market. According to the IEA, global data center electricity consumption is projected to roughly double from 485 TWh in 2025 to 950 TWh in 2030, while consumption from AI-focused data centers is expected to triple over the same period. Access to reliable power is becoming one of the main constraints on data center growth. GridFeed was built to help renewable energy operators make better decisions about every megawatt they produce, and we believe its optimization engine could be extended to help data center operators make the best use of limited power capacity. Our team is evaluating how GridFeed could support energy cost management, battery operation, workload shifting and real-time power allocation, along with potential opportunities for technology integration, pilot deployments and co-development with industry partners.

Executing a Disciplined Growth Strategy

Our strategy remains centered on creating long-term shareholder value through disciplined capital allocation focused on the development of innovative technology businesses. In addition to advancing our existing biotechnology and AI energy platforms, we continue to evaluate strategic opportunities that we believe could accelerate growth, including partnerships, licensing arrangements, investments and selective acquisitions of complementary technologies or companies. We intend to pursue such opportunities only where they strengthen our strategic position and have the potential to create sustainable long-term value for our shareholder

Looking Ahead

PRF moves toward year-end 2026 with a strengthened balance sheet, two distinct businesses with meaningful upcoming milestones and increased strategic flexibility. Our priorities are clear: initiate the OcuRing™-K Phase 2 trial, complete the establishment of GridFeed as a standalone subsidiary and advance discussions with potential strategic partners, develop GridFeed’s data center opportunity, and deploy capital responsibly to maximize long-term shareholder value.

The Board of Directors and management remain committed to disciplined execution, prudent capital allocation and transparent communication with our shareholders. On behalf of the Board and our entire team, I would like to thank you for your continued confidence, trust and support. We look forward to updating you on our progress in the months ahead.

Sincerely,

Efraim Cohen-Arazi
Interim Chief Executive Officer
PRF Technologies 

About PRF Technologies

PRF Technologies (Nasdaq: PRFX) is a company focused on the reformulation of established therapeutics, and a developer of AI-driven energy optimization technologies through its DeepSolar platform. The Company’s pharmaceutical programs leverage a proprietary extended-release drug-delivery system intended to provide prolonged post-surgical pain relief while minimizing the need for repeated dosing and reducing reliance on opioids. Through DeepSolar and GridFeed, PRF also develops advanced software solutions that enable both consumers and enterprises to monitor, forecast, trade and optimize energy – particularly in solar-integrated environments. This dual business model reflects PRF’s strategic commitment to applying precision technology across high-impact sectors including healthcare and sustainable energy. For more information, please visit www.prf-tech.com.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act and Section 21E of the Exchange Act about PRF’s expectations, beliefs and intentions including with respect to statements related to the Company’s expectations regarding its cash resources, liquidity, capital requirements and ability to fund its operations and planned activities; the Company’s expectations regarding the timing, commencement, enrollment, conduct and results of the planned Phase 2 clinical trial of OcuRing™-K, including the anticipated commencement of patient enrollment before year-end 2026; the potential safety, efficacy, benefits and commercial potential of OcuRing™-K and PRF-110; the Company’s plans for the continued development of its drug-delivery programs; the continued development and commercialization of GridFeed™ and DeepSolar Predict™, including the ability to obtain additional paid engagements and generate meaningful revenue; the Company’s plans to establish GridFeed and related operations in a separate wholly owned subsidiary and the potential benefits of such structure, including the ability to pursue strategic investments, partnerships and commercial collaborations; the potential application of GridFeed’s technology to data-center power management and other applications, including energy cost management, battery operation, workload shifting and power allocation; the Company’s ability to adapt, validate and commercialize its technology for such applications; and the Company’s ability to execute on its strategic priorities and create long-term shareholder value. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the preliminary and unaudited nature of the selected financial results included in this press release and the possibility that final reported amounts may differ; our ability to continue as a going concern, our history of significant losses, our need to raise additional capital and our ability to obtain additional capital on acceptable terms, or at all; our dependence on the success of our initial product candidate, PRF-110, OcuRing™-K, LayerBio Inc.’s lead product candidate, and the commercialization of the DeepSolar and GridFeed solutions; the outcomes of preclinical studies, clinical trials and other research regarding PRF-110, OcuRing™-K and future product candidates; our limited experience managing clinical trials; our ability to adapt the GridFeed platform to the requirements of data center operators and our limited experience in the data center market; the accuracy of third-party market projections, including those of the International Energy Agency; our ability to complete the formation of the GridFeed subsidiary and to identify, negotiate and consummate strategic partnerships, collaborations or investments at the subsidiary level on acceptable terms, or at all; our ability to retain key personnel and recruit additional employees; our reliance on third parties for the conduct of clinical trials, product manufacturing and development; the impact of competition and new technologies; our ability to comply with regulatory requirements relating to the development and marketing of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights and our ability to operate our business without infringing the intellectual property rights of others; the overall global economic environment; our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile; our ability to maintain our listing on the Nasdaq Capital Market; and statements as to the impact of the political and security situation in Israel on our business. More detailed information about the risks and uncertainties affecting us is contained under the heading “Risk Factors” included in the Company’s most recent Annual Report on Form 20-F and in other filings that we have made and may make with the Securities and Exchange Commission in the future.

Contact:

Crescendo Communications, LLC
Tel: 212-671-1020
Email: prfx@crescendo-ir.com

Dr. Ehud Geller, Chairman
PRF Technologies Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com

Broad Arrow has assembled some of the market’s most sought-after supercars and hypercars for second annual Las Vegas Auction in partnership with Concours at Wynn Las Vegas | Final highlights for the sale led by supercars across eras; 1971 Lamborghini Miura P400 SV, 1994 Bugatti EB110 GT, 2015 McLaren P1 GTR by Lanzante, 2019 Koenigsegg Regera, and 2023 Bugatti Chiron Super Sport | Catalog of 86 cars reads as a modern collectibles wish list; average year of car on offer is 1996 | Complete digital auction catalog and bidder registration available at broadarrowauctions.com

1971 Lamborghini Miura P400 SV set for Broad Arrow’s Las Vegas Auction on October 31

Credit - Courtesy of Broad Arrow Auctions
Credit – Courtesy of Broad Arrow Auctions

2023 Bugatti Chiron Super Sport to be offered at Broad Arrow’s Las Vegas Auction on October 31

Credit - Courtesy of Broad Arrow Auctions
Credit – Courtesy of Broad Arrow Auctions

Grosse Pointe, Michigan, Oct. 23, 2026 (GLOBE NEWSWIRE) — Broad Arrow Auctions, driven by Hagerty (NYSE: HGTY), is thrilled to release the complete digital catalog for its upcoming Las Vegas Auction. The sale is set for October 31 at Wynn Las Vegas, marking Broad Arrow’s second year as the official auction partner of the Concours at Wynn Las Vegas.

Curated with today’s collector in mind, the 86-car lineup reflects the market’s appetite for limited-production hypercars and analog modern classics. Final entries for the auction are led by fantastic examples of some of the world’s most sought-after supercars and hypercars, including an exceptionally restored 1971 Lamborghini Miura P400 SV, a rare and beautifully specified 2023 Bugatti Chiron Super Sport, and a track-focused 2015 McLaren P1 GTR wearing a rare road conversion by Lanzante. These latest highlights complete one of Broad Arrow’s finest offerings to date, which also includes remarkably preserved examples of Ferrari’s modern halo cars and contemporary performance icons from every top marque, complemented by truly iconic pre- and post-war classics and seldom-seen collector car rarities.

“Our 2026 Las Vegas Auction represents one of the most exciting and one of the most modern offerings the collector car market has seen,” says Alexander Weaver, Vice President and Senior Car Specialist for Broad Arrow Auctions. “The catalog truly reads like a holiday wish list for today’s serious collectors, with the average model year of the cars on offer sitting at 1996. We’re proud to present this exceptional lineup of modern collectibles, contrasted and complemented by fantastic classics and eclectic finds, alongside our partners at the Concours at Wynn Las Vegas.”

A mere sampling of the headlining cars at Broad Arrow’s Las Vegas Auction includes:

  1. 1971 Lamborghini Miura P400 SV (Estimate: $6,000,000 – $7,000,000)

    One of just 150 examples of the final, rarest, and most powerful Miura variant, chassis number 4936 has been exceptionally restored in its rare, factory original Argento over Pelle Nera black leather and retains its numbers-matching 3.9-liter V12. Recently imported to the U.S., the Miura presents the exceedingly rare opportunity to acquire not just the ultimate iteration of Lamborghini’s groundbreaking supercar, but to acquire such a car as it left the factory over fifty years ago. Its wealth of original and numbers-matching components, carefully preserved and recently expertly refreshed by some of the world’s foremost Lamborghini authorities, helps the car strike a delicate balance between delightful time capsule and masterful restoration. The Miura is offered alongside a host of thrilling modern Lamborghini supercars at the Las Vegas Auction as well. View the full lineup here.

  2. 2023 Bugatti Chiron Super Sport (Estimate: $4,300,000 – $4,700,000)

    This is one of approximately 80 examples of the luxurious and polished customer variant of the Chiron Super Sport 300+. Presented in a two-tone Argent (silver) and Black Carbon combination over Havana upholstery, the Chiron Super Sport is powered by Bugatti’s quad-turbocharged 8.0-liter W16 producing nearly 1,600 horsepower and wears over $380,000 in options, including the Sky View glass roof and diamond cut wheels. The stunning hypercar shows less than 1,900 miles from new.

  3. 2015 McLaren P1 GTR by Lanzante (Estimate: $3,200,000 – $3,500,000)

    P1 GTR number 018 is one of a mere 58 examples of the track-focused hypercar ever produced. This example is made even more special thanks to its U.S. road transformation by veteran McLaren specialists Lanzante Limited. Finished in matte black with red and carbon fiber accents, the P1 GTR shows extraordinarily low mileage at just 433 and has freshly emerged from a comprehensive service.

  4. 2019 Koenigsegg Regera (Estimate: $2,500,000 – $3,000,000)

    One of just 80 examples of Koenigsegg’s inaugural hybrid hypercar, this Regera is finished in unique “One Shade Darker Candy Apple Red” with black accents over two-tone Lingonberry and Desiato leather upholstery. Equipped with nearly $600,000 in desirable appointments, the Regera is offered in Las Vegas with just 3,106 miles at cataloging, a standout, bespoke hypercar worthy of the hobby’s finest collections.

  5. 1994 Bugatti EB110 GT (Estimate: $1,900,000 – $2,200,000)

    One of just 85 EB110 GTs produced, chassis 092 presents an exclusive opportunity to acquire one of the defining supercars of the 1990s and an essential model that heralded a renaissance for Bugatti. Handsomely presented in Grigio Chiaro over a dark gray interior with blue leather accents, this well-documented example is powered by its original quad-turbocharged 3.5-liter V12 producing 553 horsepower, paired with a six-speed manual transmission and all-wheel drive.

  6. 2001 Ferrari 550 Barchetta Pininfarina (Estimate: $1,100,000 – $1,300,000)

    This is surely one of the finest examples of a significant and highly collectible modern-era Ferrari, paying homage to the coachbuilding legacy of Pininfarina. Factory specified by a U.S.-based Ferrari VIP in the spectacular and exceedingly rare shade of Rosso Fiorano, the 550 Barchetta is offered with just 10,634 miles and boasts a new Cuoio leather interior and a recent comprehensive service by F&M Motorsport.
  7. 2003 Ferrari Enzo (Estimate: $6,500,000 – $8,500,000)

    One of only 111 delivered new to the US market, this true driver’s example of Ferrari’s singular turn-of-the-century hypercar shows under 18,000 miles at cataloging. It has been refinished by Carrozzeria Zanasi in Maranello to its original Rosso Corsa and features a Pelle Nera interior. Classiche certified and serviced in 2026 by Ferrari Dallas at a cost exceeding $10,000, this is an eminently usable example of Ferrari’s iconic hypercar.
  8. 2014 Ferrari LaFerrari (Estimate: $8,500,000 – $10,000,000)

    This is a low-mileage, extensively specified example of the first hybrid hypercar from Maranello, producing a combined 950 horsepower from its 6.3-liter V12 hybrid powerplant. One of approximately 120 examples delivered new to the U.S., the LaFerrari on offer is finished in iconic Rosso Corsa over Nero leather with Rosso accents, recently serviced, and accompanied by its battery charger, fitted car cover, and tool kit. It is offered with a two-year Certified Pre-Owned warranty, including coverage of its hybrid battery, valid through October 2028.
  9. 2025 Ferrari Daytona SP3 (Estimate: $16,000,000 – $18,000,000)

    Chassis number 314846 is a stunning example of the second model in Ferrari’s extremely sought after “Icona” series, finished in the exquisite Tailor Made shade of Verde Francesca over a two-tone Nero Alcantara and Mustard Aunde Jeans interior. Offered from its original owner, the curator of an exceptional private collection, the SP3 is an exceptionally specified example of the 600 produced and displays just 81 miles at cataloging.
  10. 1997 Ferrari F50 (Estimate: In excess of $20,000,000)

    This time-capsule F50, chassis number 107165, is a late production example, the 334th of just 349 ever built. Showing just 106 miles on the odometer, it is certainly the lowest mileage example of an end-of-an-era supercar—an unrepeatable F50. Impeccably preserved and complete with its original delivery items, including the J.P. Tod’s driving shoes and Schedoni luggage, it is as close as one can come today to taking delivery of a new F50. 

The complete digital catalog for Broad Arrow’s Las Vegas Auction is now available at broadarrowauctions.com. Interested bidders for the October 31 sale are invited to contact a Broad Arrow Car Specialist via info@broadarrowauctions.com or by calling +1-313-312-0780.

Media accreditation is currently open for the Las Vegas Auction. Members of the press on official editorial assignment, along with relevant content creators, are invited to reach out to the Broad Arrow Press Team at press@broadarrowauctions.com. Additional high-res images and interviews with Broad Arrow Executives and Specialists are available upon request.

 

Editor’s Notes  

Photo Captions/Credits: All images Courtesy of Broad Arrow Auctions.

About Broad Arrow Auctions 
Broad Arrow Auctions, driven by Hagerty (NYSE: HGTY), is a leading global collector car auction house founded in 2021 by industry veterans. As the fastest-growing auction house in its segment, Broad Arrow connects exceptional collector cars with enthusiasts worldwide through flagship events including The Broad Arrow Quail Auction (the official auction of The Quail by The Peninsula, A Motorsports Gathering), The Amelia Auction (the official auction of The Amelia Concours), The Porsche Auction in collaboration with Air | Water by Luftgekühlt, the Las Vegas Auction in partnership with Concours at Wynn Las Vegas, as well as international auctions held in partnership with Concorso d’Eleganza Villa d’Este, Zoute Grand Prix, and Auto Zürich.

Learn more at broadarrowauctions.com and follow us on Instagram, Facebook, LinkedIn, and Twitter.

About Hagerty, Inc. (NYSE: HGTY)  
Hagerty is a company built by drivers for drivers, protecting 2.8 million vehicles in the United States, Canada and the UK. We make it easier and more enjoyable for enthusiasts to drive and celebrate the machines they love through innovative insurance products, live and digital auctions, engaging media and events, as well as the Hagerty Drivers Club, the world’s largest community of car lovers.  

For more information, please visit www.hagerty.com or www.newsroom.hagerty.com.   

The Hagerty Automotive Intelligence team uses their collector car expertise to analyze Hagerty’s massive trove of public auction results, private sales and insurance data, and buyer and seller behavior. Learn more about how we collect our data at hagerty.com/valuation-tools.

Forward-Looking Statements – This press release contains statements that constitute “forward-looking statements” within the meaning of the federal securities laws. All statements provided, other than statements of historical fact, are forward-looking statements, including those regarding Hagerty’s future operating results and financial position, Hagerty’s business strategy and plans, products, services, and technology implementations, market conditions, growth and trends, expansion plans and opportunities, and Hagerty’s objectives for future operations. The words “anticipate,” “believe,” “envision,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “ongoing,” “contemplate,” and similar expressions, and the negative of these expressions, are intended to identify forward-looking statements. 

Hagerty has based these forward-looking statements largely on current expectations about future events, which may not materialize. Actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. These factors include, among other things, Hagerty’s ability to: (i) compete effectively within our industry and attract and retain our insurance policyholders and paid Hagerty Drivers Club (“HDC”) subscribers; (ii) maintain key strategic relationships with our insurance distribution and underwriting carrier partners; (iii) prevent, monitor, and detect fraudulent activity; (iv) manage risks associated with disruptions, interruptions, outages or other issues with our technology platforms or our use of third-party services; (v) accelerate the adoption of our membership and marketplace products and services, as well as any new insurance programs and products we offer; (vi) manage the cyclical nature of the insurance business, including through any periods of recession, economic downturn or inflation; (vii) address unexpected increases in the frequency or severity of claims, and (viii) comply with the numerous laws and regulations applicable to our business, including state, federal and foreign laws relating to insurance and rate increases, privacy, the internet, and accounting matters.

The forward-looking statements herein represent the judgment of Hagerty as of the date of this release and Hagerty disclaims any intent or obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments, or otherwise. This press release should be read in conjunction with the information included in Hagerty’s other press releases, reports and other filings with the Securities and Exchange Commission. Understanding the information contained in these filings is important in order to fully understand Hagerty’s reported financial results and its business outlook for future periods.

Attachments

CONTACT: Ian Kelleher
Broad Arrow Auctions
+1 917-971-4008
ikelleher@hagerty.com

Meghan McGrail
Broad Arrow Auctions
+1 519-365-8750
mmcgrail@hagerty.com

Campaign for global retailer drove more than 8.1 million impressions across Canada, before and during international soccer tournament

NEW YORK, Oct. 23, 2026 (GLOBE NEWSWIRE) — Nexxen, the advertising technology platform that delivers full-funnel performance powered by unique data and media, announced today the results of an advertising campaign for a global, big-box retailer and its media agency, Brainlabs. The campaign aimed to build broad awareness across Canada in the lead-up to this summer’s international soccer tournament. By utilizing exclusive, native connected TV (“CTV”) inventory through Nexxen TV Home Screen, it successfully drove more than 8.1 million impressions, including reaching 516,000+ unique viewers, at a prime moment: just as these audiences turned on their TVs.

Specifically, using Home Screen Hero and Banner placements across Hisense Smart TVs, powered by V OS (formerly VIDAA), the retailer extended audience reach while simultaneously building frequency throughout the tournament. The results underscore how Nexxen TV Home Screen, and home screen advertising more broadly, can empower brands to establish a high-visibility presence around tentpole events.

“Nexxen TV Home Screen was new territory for us and for our client, and a global soccer tournament was the right moment to test it,” said Ben Kahan, Head of Programmatic, Brainlabs. “We are reaching people in that split second before they’ve even decided what to watch, which is a totally different kind of attention than anything mid-roll. That alone gave us a real reason to keep this format in the plan for future tentpole moments.”

“When viewers turn on their TVs, the home screen is your brand’s first and perhaps most prominent opportunity to capture their attention,” said Kenneth Suh, Chief Business Officer, Nexxen. “This campaign demonstrates the impact of meeting audiences in that moment. Through Nexxen TV Home Screen, Brainlabs brought their client directly into viewers’ living rooms across Canada, enhancing the brand’s visibility during a major sporting event.”

About Nexxen

Nexxen is the advertising technology platform that delivers full-funnel performance powered by unique data and media. Comprised of a demand-side platform (“DSP”) and supply-side platform (“SSP”), with the Nexxen Data Platform at its core, we meet the demands of today’s converging media landscape with exclusive audience intelligence, automation and expertise. Headquartered in Israel, Nexxen maintains offices throughout North America, Europe and Asia-Pacific and is traded on Nasdaq (NEXN). For more information, please visit nexxen.com.

About Brainlabs

Brainlabs is an independent, AI-native media agency founded in 2012 by Daniel Gilbert and still founder-led, built to grow client revenue and prove the impact of every dollar spent on media. The agency delivers on that promise through a revenue-based planning process built around what actually drives revenue, not vanity metrics.

More than 250 mid-sized and enterprise brands have grown with Brainlabs. The agency has been named Fastest Growing Agency for five consecutive years by Adweek, recognized across the industry by Ad Age, Digiday, Campaign, The Drum, and Festival of Media, and rated by Notion at the highest level of AI maturity.

Brainlabs serves as a media agency of record for growth-focused, digitally native advertisers with total media spend ranging from $10M-$250M. The agency’s clients include Capital One, Microsoft, UNICEF USA, and Roblox. Learn more at brainlabsdigital.com.

Forward-Looking Statements

This press release contains forward-looking statements, including forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities and Exchange Act of 1934, as amended. Forward-looking statements are identified by words such as “anticipates,” “believes,” “expects,” “intends,” “may,” “can,” “will,” “estimates,” and other similar expressions. However, these words are not the only way Nexxen identifies forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding CTV inventory through the Nexxen TV Home Screen. These statements are neither promises nor guarantees but involve known and unknown risks, uncertainties and other important factors that may cause Nexxen’s actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: negative global economic conditions, including risks related to tariff impacts or policy shifts that could materially affect market sentiment, consumer behavior and advertising demand; global and local economic and geopolitical forces and unrest, including the war involving the United States, Israel and Iran, the war and hostilities involving Israel, Hamas, Hezbollah, and Yemen and the Ukraine/Russia war, and how those conditions may adversely impact Nexxen’s business, customers, and the markets in which Nexxen competes. Nexxen cautions you not to place undue reliance on these forward-looking statements. For a more detailed discussion of these factors, and other factors that could cause actual results to vary materially, interested parties should review the risk factors listed in the Company’s most recent Annual Report on Form 20-F, filed with the U.S. Securities and Exchange Commission (SEC.gov) on March 4, 2026. Any forward-looking statements made by Nexxen in this press release speak only as of the date of this press release, and Nexxen does not intend to update these forward-looking statements after the date of this press release, except as required by law.

For more information, please contact:

Genevieve Wheeler
Senior Director, Communications
gwheeler@nexxen.com

LAVAL, Québec, Oct. 23, 2026 (GLOBE NEWSWIRE) — Savaria Corporation, (“Savaria”) (TSX: SIS) one of the global leader in the accessibility industry, declared today a dividend of 4.916 cents ($0.04916) per common share, in accordance with its monthly dividend policy, payable on November 10, 2026, to shareholders of record of the Corporation at the close of business on October 30, 2026. This is an eligible dividend within the meaning of the Income Tax Act.

About Savaria Corporation

Savaria Corporation (corp.savaria.com) is one of the global leaders in the accessibility industry. It provides accessibility solutions for the physically challenged to increase their comfort, their mobility and their independence. Its product line is one of the most comprehensive on the market. Savaria designs, manufactures, distributes and installs accessibility equipment, such as elevators for home and commercial use, stairlifts for straight and curved stairs, vertical and inclined wheelchair lifts and dumbwaiters. In addition, Savaria manufactures and markets a comprehensive selection of pressure management products, medical beds, as well as an extensive line of medical equipment and solutions for the safe movement of patients, such as transfer, lifting and repositioning aids. The Corporation operates a sales network of dealers worldwide and direct sales offices in North America, Europe (UK, Netherlands, Switzerland, Italy, Germany, Poland and Czech Republic) and Australia. Savaria employs approximately 2,600 people globally and its plants are located across Canada, the United States, Mexico, Europe and China.

For further information:    
Sébastien Bourassa
President and CEO
1. 800.661.5112 
sb@savaria.com
Stephen Reitknecht, CPA, CA
Chief Financial Officer
1.800.661.5112, ext. 3370
sreitknecht@savaria.com

 

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