On October 12, 2023 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data from over 55 Bristol Myers Squibb-sponsored, investigator-sponsored, and collaboration studies across our oncology portfolio in more than 10 tumor types at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 to be held from October 20-24 in Madrid, Spain (Press release, Bristol-Myers Squibb, OCT 12, 2023, View Source [SID1234635881]). Data from the Phase 3 CheckMate -901 and CheckMate -77T studies have been selected for presentation in Presidential Symposium sessions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data to be presented support the role of Opdivo and Opdivo-based combinations in both earlier and metastatic stages of multiple cancer types, especially in patient groups with high unmet needs. Additional data will highlight the potential of repotrectinib in patients with TKI-naïve and -pretreated NTRK-positive solid tumors, including non-small cell lung cancer (NSCLC), as well as the benefit of treatment with Opdualag, the dual immunotherapy fixed-dose combination of the PD-1 inhibitor nivolumab and the LAG-3-blocking antibody relatlimab, in advanced melanoma.

"We are eager to share research during this year’s ESMO (Free ESMO Whitepaper) Congress on our immunotherapies and targeted therapies in both metastatic disease and earlier stages of several tumor types, including bladder cancer, melanoma and lung cancer," said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. "These new data highlight our leading development program for Opdivo and Opdivo-based combinations in earlier stages of cancer, as well as our commitment to meeting the challenging treatment needs of cancer patients by both continuing to study the potential of our existing medicines as well as advancing new assets that may target cancer’s vulnerabilities more precisely."

Key data highlighting approved or investigational therapies from Bristol Myers Squibb at ESMO (Free ESMO Whitepaper) 2023 include:

First presentation of overall survival (OS) and progression-free survival (PFS) data from the Phase 3 CheckMate -901 trial of Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy in the first-line treatment of patients with unresectable or metastatic urothelial carcinoma demonstrating survival benefits over standard-of-care cisplatin-based chemotherapy. CheckMate -901 is the first Phase 3 trial with an immunotherapy-based combination to demonstrate a survival benefit compared to standard-of-care cisplatin-based chemotherapy in the first-line treatment of this patient population. These data will be presented at the Presidential Symposium on Sunday, October 22.
First presentation of data from the Phase 3 CheckMate -77T trial of the perioperative regimen of neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB NSCLC. CheckMate -77T is the second positive Phase 3 trial of an Opdivo-based combination for the treatment of non-metastatic NSCLC. These data will be presented at the Presidential Symposium on Saturday, October 21.
Late-breaking results from the Phase 3 CheckMate -816 study of neoadjuvant Opdivo with chemotherapy showing improved clinical benefit according to PD-L1 expression status in patients with resectable NSCLC. Additional CheckMate -816 results will also be presented showing efficacy benefits with Opdivo plus Yervoy in resectable NSCLC.
Updated results from the registrational TRIDENT-1 trial demonstrating clinical benefit with repotrectinib in patients with NTRK-positive advanced solid tumors, including NSCLC, who often develop resistance to existing therapies.
Seven-year efficacy results from the Phase 3 CheckMate -238 trial of adjuvant Opdivo in resected stage III/IV melanoma pointing to sustained benefits and reinforcing BMS’ leadership in earlier stages of melanoma.
Subgroup data from the Phase 2/3 RELATIVITY-047 trial showing consistent benefit across subgroups with the company’s third distinct checkpoint inhibitor Opdualag (nivolumab and relatlimab-rmbw) in the first-line treatment of patients with advanced melanoma.
Summary of Select Presentations:

Abstract Title

Author

Presentation

Type/#

Session Title

Session/Poster Discussion

Date/Time@

Adrenocortical Carcinoma

EO2401 (E) peptide immunotherapy + nivolumab (N) in adrenocortical carcinoma (ACC) and metastatic pheochromocytoma/paraganglioma (MPP); EOADR1-19/SPENCER

Eric Baudin

Proffered Paper

Abstract #724O

Proffered paper session – NETs and endocrine tumors

Sunday, October 22

08:30 – 10:00 CEST / 2:30 – 4:00 AM EDT

Gastrointestinal

Factors associated with uptake of adjuvant nivolumab in a nationwide esophageal cancer patient cohort

Robert Verhoeven

Poster

Abstract #1575P

Oesophagogastric cancer

Monday, October 23

Onsite poster display

Genitourinary

Nivolumab plus gemcitabine-cisplatin vs gemcitabine-cisplatin alone for previously untreated unresectable or metastatic urothelial carcinoma: results for cisplatin-eligible patients in the phase 3 CheckMate 901 trial

Michiel van der Heijden

Proffered Paper

Abstract

#LBA7

Presidential 2

Sunday, October 22

16:30 – 18:15 CEST / 10:30 AM – 12:15 PM EDT

Clinical management and outcomes of patients with advanced renal cell carcinoma (aRCC) treated with nivolumab+ipilimumab (N+I): a real-world study

Tom Geldart

Poster

Abstract #1896P

Renal cancer

Monday, October 23

Onsite poster display

Treatment patterns among novel hormonal therapy-experienced patients with metastatic castration-resistant prostate cancer

Vivek Narayan

Poster

Abstract #1824P

Prostate cancer

Sunday, October 22

Onsite poster display

STELLAR-304: A randomized phase 3 study of zanzalintinib (XL092) and nivolumab in non-clear cell renal cell carcinoma (nccRCC)

Sumanta Pal

Poster

Abstract #1912TiP

Renal cancer

Monday, October 23

Onsite poster display

Glioblastoma

Trotabresib (CC-90010) combined with concomitant temozolomide (TMZ) plus radiotherapy (RT) and adjuvant TMZ in patients (pts) with newly diagnosed primary glioblastoma (ndGBM): updated results from a phase 1b/2 study

Maria Vieito Villar

Proffered Paper

Abstract #500O

Proffered paper session – CNS tumors

Friday, October 20

16:00 – 17:30 CEST / 10:00-11:30 AM EDT

Gynecological

Antitumor activity of farletuzumab ecteribulin in a panel of endometrial cancer patient-derived xenografts with four different molecular subtypes

Kosei Hasegawa

Poster

Abstract #786P

Gynecological cancers

Sunday, October 22

Onsite poster display

A randomized, double-blind trial of nivolumab (NIVO) vs placebo (PBO) with neoadjuvant chemotherapy (NACT) followed by adjuvant endocrine therapy (ET) ± NIVO in patients (pts) with high-risk, ER+ HER2− primary breast cancer (BC)

Sherene Loi

Proffered Paper

Abstract #LBA20

Proffered paper session – Breast cancer, early stage

Friday, October 20

14:00 – 15:40 CEST / 8:00 – 9:40 AM EDT

Head and Neck

Nivolumab (nivo) in recurrent and/or metastatic squamous cell carcinoma of head and neck (R/M SCCHN): real-world effectiveness, quality of life (QoL) of patients and their caregivers in France (ProNiHN study)

Christophe Le Tourneau

Poster

Abstract #938P

Head and neck cancers, excl. thyroid

Sunday, October 22

Onsite poster display

Patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) treated with nivolumab (NIVO) in the first-line (1L) or later-line (2L+) settings in Germany: Updated results from the real-world HANNA study

Boris Kubuschok

Poster

Abstract #927P

Head and neck cancers, excl. thyroid

Sunday, October 22

Onsite poster display

Thoracic

CheckMate 77T: Phase 3 study comparing neoadjuvant nivolumab (NIVO) plus chemotherapy (chemo) vs neoadjuvant placebo plus chemo followed by surgery and adjuvant NIVO or placebo for previously untreated, resectable stage II–IIIB NSCLC

Tina Cascone

Proffered Paper

Abstract

#LBA1

Presidential 1

Saturday, October 21

16:30 – 18:15 CEST / 10:30 AM – 12:15 PM EDT

Neoadjuvant nivolumab (N) + ipilimumab (I) vs chemotherapy in the phase 3 CheckMate 816 trial

Mark Awad

Proffered Paper

Abstract #1261O

Proffered paper session – non-metastatic NSCLC and other thoracic malignancies

Friday, October 20

14:00 – 15:45 CEST / 8:00 – 9:45 AM EDT

Neoadjuvant nivolumab (N) + chemotherapy (C) in the phase 3 CheckMate 816 study: 3-y results by tumor PD-L1 expression

Mariano Provencio Pulla

Mini Oral

Abstract #LBA57

Mini oral session 2 – non-metastatic NSCLC and other thoracic malignancies

Monday, October 23

14:45 – 15:55 CEST / 8:45 – 9:55 AM EDT

Repotrectinib in patients (pts) with NTRK fusion-positive (NTRK+) advanced solid tumors, including NSCLC: Update from the phase 1/2 TRIDENT-1 trial

Ben Solomon

Poster

Abstract #1372P

NSCLC, metastatic

Monday, October 23

Onsite poster display

Nivolumab (nivo) resumption in patients with advanced or metastatic non-small cell lung cancer (aNSCLC): Survival outcomes based on France and Germany real-world data (RWD)

Maurice Pérol

Poster

Abstract #1455P

NSCLC, metastatic

Monday, October 23

Onsite poster display

First-line nivolumab (NIVO) plus ipilimumab (IPI) with two cycles of chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC): Results from an interim analysis of the non-interventional FINN study

Jonas Kuon

Poster

Abstract #1448P

NSCLC, metastatic

Monday, October 23

Onsite poster display

SAPPHIRE: Phase 3 Study of sitravatinib Plus nivolumab Versus Docetaxel in Patients with Previously Treated Advanced Non-Squamous Non-Small Cell Lung Cancer

Hossein Borghaei

Proffered Paper

Abstract #LBA63

Proffered paper session – NSCLC, metastatic

Friday, October 20

16:00 – 17:30 CEST / 10:00 – 11:30 AM EDT

Melanoma

Adjuvant nivolumab (NIVO) vs ipilimumab (IPI) in resected stage III/IV melanoma: 7-y results from CheckMate 238

Paolo Ascierto

Poster

Abstract #1089P

Melanoma and other skin tumors

Sunday, October 22

Onsite poster display

Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: 2-year subgroup analyses from RELATIVITY-047

Georgina Long

Poster

Abstract #1103P

Melanoma and other skin tumors

Sunday, October 22

Onsite poster display

Comparison of intracranial (IC) response assessment criteria in patients (pts) with melanoma brain metastases (MBM) treated with combination nivolumab (NIVO) plus ipilimumab (IPI) in CheckMate 204

Raymond Huang

Poster

Abstract #1135P

Melanoma and other skin tumors

Sunday, October 22

Onsite poster display

Unraveling relatlimab (RELA)-specific biology using biomarker analyses in patients with advanced melanoma treated with nivolumab (NIVO)+RELA or NIVO alone in RELATIVITY-047

Evan Lipson

Mini Oral

Abstract #LBA51

Mini oral session – Melanoma and other skin tumors

Saturday, October 21

14:45 – 16:10 CEST / 8:45 – 10:10 AM EDT

Evaluation of surrogate endpoints for overall survival within the RELATIVITY-047 trial

Peter Mohr

Poster

Abstract #1102P

Melanoma and other skin tumors

Sunday, October 22

Onsite poster display

Cross-Tumor/Solid Tumor

Recommended phase 2 dose (RP2D) selection and pharmacodynamic (PD) data of the first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients (pts) with advanced HER2-expressing solid tumors

Bob Li

Mini Oral

Abstract #657MO

Mini oral session – Developmental therapeutics

Monday, October 23

16:30 – 18:00 CEST / 10:30 AM – 12:00 PM EDT

Clinical benefit of immunotherapies in advanced cancer in France: a population-based estimate from 2014 to 2021

Isabelle Borget

Poster

Abstract #1752P

Policy and preventive strategies

Sunday, October 22

Onsite poster display

Early Assets

GUIDE.MRD: A Consortium Guiding Multi-Modal Therapies Against Minimal Residual Disease (MRD) by Liquid Biopsy to Assess Implementation of circulating tumor DNA (ctDNA) in Clinical Practice to Improve Patient Outcomes

Klaus Pantel

Poster

Abstract #237TiP

Biomarkers (agnostic)

Saturday, October 21

Onsite poster display

All abstracts except late-breaking abstracts will be available on the ESMO (Free ESMO Whitepaper) website at 00:05 CEST Monday, October 16 (6:05 PM EDT on Sunday, October 15). All late-breaking abstracts will be available on the ESMO (Free ESMO Whitepaper) website at 00:05 CEST on Thursday, October 19 (6:05 PM EDT on Wednesday, October 18).

On October 12, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the European Patent Office (EPO) has granted the company a new patent based on EP Patent No. 3323834 covering its lead drug candidate mitazalimab, a CD40 monoclonal antibody currently being evaluated in a Phase 2 study in 1st line metastatic pancreatic cancer (Press release, Alligator Bioscience, OCT 12, 2023, View Source [SID1234635880]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The patent, titled "Anti-CD40 Antibodies, Uses and Methods", protects composition of matter for mitazalimab and other CD40 monoclonal antibodies until 2038 (including potential supplementary term). The new patent expands protection for mitazalimab in Europe and brings the total number of patents in the mitazalimab intellectual property portfolio to 48 granted patents and 25 pending patents covering multiple territories, including Europe, North America, Asia, and more.

"The protection of our intellectual property is one of the key pillars of our business strategy, providing a strong foundation for our drug development program and our plans to commercialize our assets," said Søren Bregenholt, CEO of Alligator Bioscience. "The granting of this new patent is a significant addition to our overall patent portfolio, providing vital further protection for our lead clinical asset in Europe. It also comes at an excellent timing with mitazalimab making outstanding progress in the clinic and advancing on its route to market."

Mitazalimab is being evaluated in combination with chemotherapy, mFOLFIRINOX, in the OPTIMIZE-1 Phase 2 study in 1st line metastatic pancreatic cancer. The study is progressing and is on track for top-line readout in early Q1 2024.

On October 11, 2023 SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, reported that it has dosed the first patients in the combination therapy arms of its Phase 1/2 CLAUDIO-01 trial. CLAUDIO-01 is evaluating SOTIO’s potent antibody-drug conjugate SOT102 in patients with gastric and pancreatic cancer (Press release, SOTIO, OCT 11, 2023, View Source [SID1234635870]). The combination arms will be the first clinical evaluation of SOT102’s potential as a first-line cancer treatment in combination with current standard of care. In the gastric cancer arm, SOT102 will be combined with mFOLFOX plus nivolumab. In the pancreatic cancer arm, SOT102 will be combined with Nab-paclitaxel plus gemcitabine.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The initiation of the combination arms in our Phase 1/2 CLAUDIO-01 trial represents an exciting clinical milestone in the development of SOT102 and our pursuit to provide novel and improved treatment options for patients suffering from solid tumors. The opportunity to evaluate SOT102 as part of a first-line treatment regimen will provide us valuable insights that could greatly expand the patient population who could benefit from this therapy," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. "We look forward to collaborating with our clinical sites to carry out these studies, as we work to deliver immunotherapies that can make a meaningful difference in the lives of patients with solid tumors."

CLAUDIO-01 (EudraCT number: 2021-005873-25) is a Phase 1/2 first-in-human, open-label, multicenter trial to assess the safety and preliminary efficacy of SOT102. SOTIO is progressing dose-finding studies in the trial’s monotherapy arm, in which SOT102 is used as a later-stage treatment. In the trial’s combination arm, by contrast, SOT102 will be dosed in combination with standard-of-care as a first-line treatment for patients with advanced/metastatic gastric/gastroesophageal junction (GEJ) or pancreatic cancers. To date the trial has reported no dose-limiting toxicities.

About SOT102

SOT102 is a potent antibody-drug conjugate that combines the clinically-validated target Claudin 18.2 (CLDN18.2) with a powerful toxin to address gastric, pancreatic and other cancers that have very few targeted treatments available. Preclinical data from studies of SOT102 have demonstrated potent anti-tumor efficacy in vitro and in vivo. SOT102 is currently being studied for the treatment of gastric and pancreatic cancers in the CLAUDIO-01 Phase 1/2 clinical trial at leading centers in Europe and the United States.

On October 11, 2023 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported recent updates in its lung cancer detection program for early-stage disease (Press release, Nucleix, OCT 11, 2023, View Source [SID1234635869]). At the American College of Chest Physicians (CHEST) 2023 Annual Meeting yesterday, Dr. Peter Mazzone, M.D., MPH, Director of the Lung Cancer Program and Lung Cancer Screening Program for the Respiratory Institute at the Cleveland Clinic and co-principal investigator of the Sightline study, presented initial performance data from the Sightline study, a prospective multi-center, case-control study evaluating the performance of Lung EpiCheck. Additionally, the company strengthened its leadership team with the appointment of Mathias Ehrich, M.D., as its chief scientific officer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data Presented at CHEST

Earlier this year, the company announced that the Nucleix EpiCheck Lung Atlas, which utilizes next-generation sequencing (NGS) and is focused on stage I disease, had identified many promising, novel biomarkers for the early detection of lung cancer. Dr. Mazzone’s presentation, "Enhanced detection of early-stage lung cancer with an ultrasensitive plasma-based methylation assay," outlined initial performance data of the company’s Lung EpiCheck polymerase chain reaction (PCR) assay, which includes novel biomarkers discovered as part of the development of the Nucleix EpiCheck Lung Atlas.

In an initial evaluation of clinical performance, the Lung EpiCheck PCR assay demonstrated an AUC between 0.841 – 0.871; stage I non-small cell lung cancer (NSCLC) sensitivity ranged between 87.1% – 87.2%; and overall sensitivity ranged between 89.9% – 91.6%. These data were based on an analysis of 813 subjects (188 cases and 625 controls) at high-risk of lung cancer. Tumor characteristics in these subjects were similar to the screening arm of the National Lung Screening Trial, with 60% early-stage (stage I & II) NSCLC and 65% of stage I tumors smaller than 20mm.

"Over the past few months, we’ve made incredible progress on our lung cancer program, having recently premiered data on the Nucleix EpiCheck Lung Atlas and enrolled more than 4,000 patients in the Sightline study," said Chris Hibberd, chief executive officer of Nucleix. "We are encouraged by this data readout presented at CHEST, as it further demonstrates the discovery capabilities of the Nucleix EpiCheck Lung Atlas and the potential of Lung EpiCheck as a non-invasive test to aid in the detection of early-stage lung cancer in people at high risk for lung cancer."

"The five-year survival rates for lung cancer are up to 10 times greater when detected early,i but unfortunately, most patients are still diagnosed in later stages of the disease," said Dr. Mazzone. "The Sightline investigators are very excited with the results demonstrating that a tool like Lung EpiCheck could have a major impact on lung cancer screening, as it offers a simple and non-invasive solution to catch the disease at stage I or II when patients have much higher chances to be cured."

Key Executive Appointed

Mathias Ehrich, M.D., joins Nucleix with more than two decades of medical and scientific experience. Previously the co-founder, chief scientific officer and chief medical officer of Juno Diagnostics, Dr. Ehrich brings significant expertise in diagnostics and product development using NGS-based screening tools. Prior to Juno Diagnostics, Dr. Ehrich lead the innovation and advancement of the world’s first NGS-based, cell-free DNA test for non-invasive prenatal screening. At Nucleix, Dr. Ehrich will lead and oversee R&D, product development, clinical development, and strategic research for the company’s lung cancer detection program for early-stage disease.

"I was impressed by the data the company presented on the Nucleix EpiCheck Lung Atlas earlier this year, the potential of its Lung EpiCheck assay and the company’s differentiated approach for the discovery and identification of novel biomarkers for non-invasive lung cancer screening," said Dr. Ehrich. "I am honored to join the team and look forward to further advancing this program to detect lung cancer earlier when treatment can be more effective for patients."

On October 11, 2023 Scholar Rock Holding Corporation (Nasdaq: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported the pricing of an upsized underwritten public offering of 12,408,760 shares of its common stock at a public offering price of $6.85 per share (Press release, Scholar Rock, OCT 11, 2023, View Source [SID1234635868]). The aggregate gross proceeds to Scholar Rock from this offering are expected to be approximately $85.0 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares are being offered by Scholar Rock. The offering is expected to close on October 16, 2023, subject to the satisfaction of customary closing conditions. In addition, Scholar Rock has granted the underwriters a 30-day option to purchase up to an additional 1,861,314 shares of common stock at the public offering price, less the underwriting discounts and commissions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Scholar Rock intends to use the net proceeds from the offering to advance apitegromab, develop its clinical and preclinical pipeline, as well as for working capital and other general corporate purposes.

J.P. Morgan Securities LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. BMO Capital Markets Corp. and Wedbush Securities Inc. are acting as co-managers for the offering.

The securities described above are being offered by Scholar Rock pursuant to a shelf registration statement on Form S-3 (No. 333-268329) that was declared effective by the Securities and Exchange Commission (SEC) on November 25, 2022. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering were filed with the SEC on October 11, 2023, and are available on the SEC’s website located at www.sec.gov. A copy of the final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting: J.P. Morgan Securities LLC, c/o: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 866-803-9204 or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at 800-747-3924 or by email at [email protected].

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