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New Data from a Long-Term Follow-up Study to the OLYMPUS Trial Show Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO®

New Data from a Long-Term Follow-up Study to the OLYMPUS Trial Show Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO®

The Study Results are Published in the Journal of Urology Online

PRINCETON, N.J.–(BUSINESS WIRE)–
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights results from a long-term follow-up study with JELMYTO (mitomycin) for pyelocalyceal solution, which is FDA approved for the treatment of low-grade, upper tract urothelial cancer (LG-UTUC) in adult patients. Among patients from the OLYMPUS trial who achieved a complete response after primary chemoablation with JELMYTO (n=41, 20 of whom entered the long-term follow-up study), the median duration of response was 47.8 months (median follow-up 28.1 months [95% CI 13.1, 57.5]). The study results are published online in the Journal of Urology.

“The median DOR of 47.8 months in patients who achieved complete response with JELMYTO provides evidence of robust durability in maintaining control of low-grade UTUC over an extended period,” said Phillip Pierorazio, M.D., Chief, Section of Urology, Penn Presbyterian Medical Center, Professor of Surgery, Hospital of the University of Pennsylvania in Philadelphia, P.A., study author and member of the American Urological Association (AUA)/ Annual Society of Urological Oncology (SUO) UTUC Guideline Committee. “The AUA/SUO recommend that urologists use kidney-sparing techniques as the preferred management strategy for patients with low-grade UTUC when possible. JELMYTO, with this evidence for extended durability of complete response, offers the opportunity for durable recurrence-free intervals.”

Of the 71 patients enrolled in OLYMPUS, 41 achieved a complete response after treatment with JELMYTO and had a median duration of response of 47.8 months (95% CI 13.0, not estimable), with median follow-up of 28.1 months (95% CI 13.1, 57.5).

“Previous research indicates that managing relapse and preserving organ function should be the primary treatment goal for LG-UTUC due to the low risk of disease progression,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “We are encouraged by the study’s findings providing compelling evidence for favorable long-term durability of JELMYTO as a primary treatment for LG-UTUC, with increasing evidence showing extended response times in some patients.”

The analysis has certain limitations, including its post-hoc nature and the inherent selection bias of the 20 patients enrolled in the long-term follow-up study.

To further explore the potential of JELMYTO in treating patients with UTUC, investigators are currently enrolling participants in the JELMYTO uTRACT Registry to gather longitudinal real-world usage data. As of July 10, 19 sites have been activated with 191 patients enrolled.

About JELMYTO

JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with low-grade-UTUC (LG-UTUC). It is approved for adult patients with LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

About Upper Tract Urothelial Cancer (UTUC)

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as UTUC. In the U.S., there are approximately 6,000 – 7,000 new or recurrent LG-UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). Treatment with endoscopic surgery can lead to a high rate of recurrence and relapse.

About UroGen Pharma Ltd.

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat LG-UTUC and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on X (Twitter), @UroGenPharma.

APPROVED USE FOR JELMYTO

JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

  • are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.

  • are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.

  • Tell your healthcare provider if you take water pills (diuretic).

How will I receive JELMYTO?

  • Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.

  • You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.

  • JELMYTO is given to your kidney through a tube called a catheter.

  • During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

After receiving JELMYTO:

  • JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.

  • To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.

  • Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

JELMYTO may cause serious side effects, including:

  • Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
  • Bonemarrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
  • The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1800FDA1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding plans to enroll participants in the JELMYTO uTRACT Patient Registry to gather longitudinal real-world usage data; the estimated patient population and demographics for UTUC; the potential of UroGen’s proprietary RTGeltechnology to improve therapeutic profiles of existing drugs; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: prior results may not be indicative of results that may be observed in the future; potential safety and other complications from JELMYTO use in diverse UTUC patient types; and UroGen’s RTGel technology may not perform as expected and we may not successfully develop and receive regulatory approval of any other product that incorporates UroGen’s RTGel technology. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 6, 2024 (which is available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.

INVESTOR CONTACT:

Vincent Perrone

Senior Director, Investor Relations

[email protected]

609-460-3588 ext. 1093

MEDIA CONTACT:

Cindy Romano

Director, Corporate Communications

[email protected]

609-460-3583 ext. 1083

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Oncology Health Research Pharmaceutical Science Biotechnology

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DigitalOcean to Participate in UBS Global Technology and AI Conference

DigitalOcean to Participate in UBS Global Technology and AI Conference

NEW YORK–(BUSINESS WIRE)–DigitalOcean Holdings, Inc. (NYSE: DOCN), the simplest scalable cloud for digital-native businesses, today announced that Chief Executive Officer Paddy Srinivasan will participate in a fireside chat at the UBS Global Technology and AI Conference on Tuesday, December 3, 2024 at 12:35 p.m. (PT) / 3:35 p.m. (ET).

A live webcast and replay will be available on DigitalOcean’s investor relations website at investors.digitalocean.com.

About DigitalOcean

DigitalOcean simplifies cloud computing so businesses can spend more time creating software that changes the world. With its mission-critical infrastructure and fully managed offerings, DigitalOcean helps developers at startups and growing digital-native businesses rapidly build, deploy and scale – whether creating a digital presence or building digital products. DigitalOcean combines the power of simplicity, security, community and customer support so customers can spend less time managing their infrastructure and more time building innovative applications that drive business growth. For more information, visit digitalocean.com.

DigitalOcean Media

Dan Jensen

[email protected]

Investors

Melanie Strate

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Software Technology Artificial Intelligence Other Technology

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Walmart Canada and DoorDash Canada Join Forces To Bring Everyday Low Prices To More Canadians

Walmart Canada and DoorDash Canada Join Forces To Bring Everyday Low Prices To More Canadians

The partnership spans over 300 Walmart Supercentres across 10 provinces, providing millions of Canadians with high-quality grocery and general merchandise products via on-demand delivery.

TORONTO–(BUSINESS WIRE)–
DoorDash Canada (NASDAQ: DASH) and Walmart Canada today announced a nationwide collaboration, providing more Canadians across the country with on-demand access to grocery and general merchandise essentials. This comes as Canadians continue to seek affordable and convenient shopping options, which they can now find at Walmart through DoorDash’s easy-to-use app and website.

“We’re thrilled to collaborate with DoorDash to offer Canadians another fast and convenient way to access our broad assortment, right at their fingertips,” said Ignacio Baladron, Vice President, Omni Channel & Online Grocery at Walmart Canada. “DoorDash opens our doors to Canadians who are strapped for time, in need of last-minute items or who prefer to shop from the comfort of their home – especially as we head into the holiday season. We’re proud to continue our journey to become the number one omnichannel retailer as we live out our mission of helping Canadians save money so they can live better.”

Customers shopping on DoorDash can now browse tens of thousands of unique items from Walmart – including beloved private label brands like Great Value, Equate, and Mainstays – ranging from fresh produce and kitchenware to pet food and electronics. Once an order is placed from Walmart on DoorDash’s app or website, a nearby Dasher will shop for each item on a customer’s list. Forget something? Customers can continue adding items to their cart until a Dasher arrives at the store to begin shopping.

“Families look to DoorDash to support their weekly routines, and through our collaboration with Walmart, we’re proud to connect them with access to fresh produce, pantry staples, and home goods on demand,” said Shilpa Arora, General Manager of DoorDash Canada. “Customers continue to enjoy the convenience of delivery for a variety of occasions, whether that’s searching for an easy weeknight meal or ordering gifts for the holidays.”

Canadians across the country can now shop grocery and general merchandise from over 300 Walmart Supercentres in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, Prince Edward Island, Quebec, and Saskatchewan – enjoying delivery right to their doors. Roughly 4 in 5 customers who shopped on DoorDash in Canada in the last 60 days will now have access to convenient and reliable on-demand delivery from Walmart.

All Walmart Supercentres on DoorDash will be available on DashPass, DoorDash’s subscription program, providing $0 delivery fees and reduced service fees on eligible orders.* Place an orderfrom Walmart on DoorDash.

*DashPass benefits apply only to eligible orders that meet the minimum subtotal requirement listed on DoorDash for each participating merchant. Other fees (including service fee), taxes, and gratuity still apply. After signing up for DashPass, you will be charged the then-current renewal price (plus applicable taxes) automatically on a recurring basis until you cancel. DashPass terms (including how to cancel) here.

About DoorDash

DoorDash (NASDAQ: DASH) is a technology company that connects consumers with their favourite local businesses in more than 30 countries across the globe. Founded in 2013, DoorDash builds products and services to help businesses innovate, grow, and reach more customers. DoorDash is your door to more: the local commerce platform dedicated to enabling merchants to thrive in the convenience economy, giving consumers access to more of their communities, and providing work that empowers.

About Walmart

Walmart Canada operates a chain of more than 400 stores nationwide serving 1.5 million customers each day. Walmart Canada’s flagship online store, Walmart.ca, is visited by more than 1.5 million customers daily. With more than 100,000 associates, Walmart Canada is one of Canada’s largest employers and is ranked one of the country’s top 10 most influential brands. Walmart Canada’s extensive philanthropy program is focused on supporting Canadian families in need, and since 1994 Walmart Canada has raised and donated more than $750 million to Canadian charities. Additional information can be found at walmartcanada.ca and on Walmart Canada’s social media pages – Facebook, X, Instagram, and LinkedIn.

[email protected]

KEYWORDS: United States North America Canada California

INDUSTRY KEYWORDS: Delivery Services Consumer Electronics Retail Other Retail Technology Other Technology Food/Beverage

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Rallybio to Present at the 2024 Evercore ISI HealthCONx Conference

Rallybio to Present at the 2024 Evercore ISI HealthCONx Conference

NEW HAVEN, Conn.–(BUSINESS WIRE)–
Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced that Stephen Uden, M.D., Chief Executive Officer of Rallybio, will participate in a fireside chat at the Evercore ISI HealthCONx Conference on Wednesday, December 4, 2024 at 12:30 p.m. ET in Coral Gables, FL.

A live webcast of the fireside chat will be accessible through the Events and Presentations section of Rallybio’s website at www.rallybio.com. An archived replay of the webcast will be available for 30 days following the presentation.

About Rallybio

Rallybio (NASDAQ: RLYB) is a clinical-stage biotechnology company with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Rallybio has built a broad pipeline of promising product candidates aimed at addressing diseases with unmet medical need in areas of maternal fetal health, complement dysregulation, hematology, and metabolic disorders. The Company has two clinical stage programs: RLYB212, an anti-HPA-1a antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT) and RLYB116, a C5 inhibitor with the potential to treat several diseases of complement dysregulation, as well as additional programs in preclinical development. Rallybio is headquartered in New Haven, Connecticut. For more information, please visit www.rallybio.com and follow us on LinkedIn and Twitter.

Investor Contacts

Samantha Tracy

Rallybio Corporation

(475) 47-RALLY (Ext. 282)

[email protected]


Kevin Lui

Precision AQ

(212) 698-8691

[email protected]


Media

Victoria Reynolds

Mission North

(760) 579-2134

[email protected]

KEYWORDS: United States North America Florida Connecticut

INDUSTRY KEYWORDS: Research Finance Clinical Trials Professional Services Biotechnology Health Pharmaceutical General Health Science

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Silence Therapeutics to Participate in Fireside Chat at Piper Sandler 36th Annual Healthcare Conference

Silence Therapeutics to Participate in Fireside Chat at Piper Sandler 36th Annual Healthcare Conference

LONDON–(BUSINESS WIRE)–
Silence Therapeutics plc, Nasdaq: SLN (“Silence” or the “Company”), a global clinical stage biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines, today announced the Company will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on Wednesday, December 4th at 10:00 a.m. ET.

The live webcast can be accessed via the Investors section of the Silence website at www.silence-therapeutics.com. An archived replay of the webcast will be available following the conference.

About Silence Therapeutics

Silence Therapeutics is a global clinical stage biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines created with proprietary siRNA (short interfering RNA) technology. Silence leverages its mRNAi GOLD™ platform to create innovative siRNAs designed to precisely target and silence disease associated genes in the liver, which represents a substantial opportunity. Silence focuses on areas of high unmet medical need with programs advancing in cardiovascular disease, hematology and rare diseases. Silence also maintains research and development collaborations with AstraZeneca and Hansoh Pharma, among others. For more information, please visit https://www.silence-therapeutics.com/.

Inquiries:

Silence Therapeutics plc

Gem Hopkins, VP, Head of IR and Corporate Communications

[email protected]

Tel: +1 (646) 637-3208

KEYWORDS: Europe Ireland United Kingdom

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Clinical Trials

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ParaZero Partners with Drone Nerds to Expand SafeAir Systems Reach Across North America

Tel Aviv, Israel, Nov. 26, 2024 (GLOBE NEWSWIRE) — ParaZero Technologies Ltd. (Nasdaq: PRZO) (the “Company” or “ParaZero”), an aerospace company focused on safety systems for defense and commercial drones and urban air mobility aircraft, announced today that it has partnering with Drone Nerds Inc., one of North America’s largest enterprise drone solution providers. This collaboration marks a significant step forward in making ParaZero’s innovative SafeAir Parachute Recovery System accessible to enterprise customers across industries as the Company expands its reach across in North America.

The ParaZero SafeAir System is designed to autonomously detect and mitigate flight risks in real-time. The system empowers drone operators with a robust safety solution to ensure mission continuity, even in the most complex operational environments.

By integrating flight pattern monitoring and autonomous response mechanisms, including parachute deployment and audible alerts, the SafeAir system safeguards people, property and valuable drone assets. Through this partnership, Drone Nerds will introduce SafeAir to a broader customer base, enhancing operational safety and compliance for enterprise users.

Boaz Shetzer, CEO of ParaZero, commented: ” Our partnership with Drone Nerds is a major milestone for ParaZero as we continue to expand our footprint in North America. We believe that Drone Nerds’ extensive reach and commitment to excellence align perfectly with our mission to elevate drone safety standards and enable advanced UAS operations including Operation Over People and BVLOS.”

Drone Nerds, known for its unparalleled expertise in drone solutions, will offer the SafeAir System across its expansive network of enterprise clients, serving industries such as public safety, agriculture, energy, and construction.

“As part of our commitment to providing innovative solutions, we’re thrilled to introduce SafeAir to our lineup,” stated Jeremy Schneiderman, CEO of Drone Nerds. “This technology gives operators the assurance they need to safely scale their drone missions and explore new possibilities, even in challenging environments.”

SafeAir is recognized globally for meeting the highest safety certifications, including ASTM standards, and earning approvals from both the FAA and EASA. These accolades position the system as an essential tool for enterprises seeking to scale drone operations, from BVLOS (Beyond Visual Line of Sight) missions to operations over people and drone delivery.

About ParaZero Technologies

ParaZero (Nasdaq: PRZO) is a leading developer of autonomous parachute safety systems technologies for commercial and military platforms as well as for urban air mobility (UAM) aircraft. Started in 2014 by a passionate group of aviation professionals and drone industry veterans, ParaZero develope and manufacture smart, autonomous parachute safety systems designed to enable safe flight operations over populated areas and beyond-visual-line-of-sight (BVLOS) as well as for various military applications including Counter UAS. For more information about ParaZero, please visit https://parazero.com/

About DroneNerds

Established in 2014, Drone Nerds focuses on ensuring its customers have the right UAV solution for their unique operational needs. With its proprietary Always Flying™ program, Drone Nerds provides reliability and assurance for enterprise implementations across industry verticals, including public safety, government, agriculture, construction, energy, inspection, and more.

For more information, visit https://enterprise.dronenerds.com/


Forward- looking statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, ParaZero is using forward-looking statements when it discusses expanding its reach across North America and its mission to elevate drone safety standards and enable advanced UAS operations including Operation Over People and BVLOS . Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on From 20-F for the year ended December 31, 2023. Forward- looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. ParaZero is not responsible for the content of third-party websites.

Investor Relations Contact:

Michal Efraty
Investor Relations
[email protected]



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BriaCell 2024 SABCS® Spotlight Poster to Showcase Positive Overall Survival Data Across All Patient Subtypes in Metastatic Breast Cancer


  • SABCS® “Spotlight” poster to be presented on Wednesday, December 11, 2024 7:00 AM – 8:30 AM CST highlights positive BriaCell survival and clinical benefit data across all metastatic breast cancer patient subtypes

  • Median



    overall survival of 13.4 months exceeds historical controls



    . Phase 2 final median overall survival calculation is pending, as many patients remain alive

  • Potential identification of biomarkers to predict response

  • Five poster presentations to feature increased presence of cancer fighting CD8+ “killer” T cell in metastatic breast cancer tumors, response in central nervous system (CNS) metastases and additional Bria-IMT™ clinical data from the Phase 2 trial of Bria-IMT™ + immune check point inhibitor in metastatic breast cancer

  • Collaboration with the Medical College of Wisconsin will investigate use of Bria-IMT™ + CPI in any cancer patient with central nervous system (CNS) metastases

PHILADELPHIA and VANCOUVER, British Columbia, Nov. 26, 2024 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, will be highlighting its positive overall survival and clinical benefit data in metastatic breast cancer (MBC) patients including those with CNS metastasis (not shown on the abstracts) who were treated with the Bria-IMT™ plus immune checkpoint inhibitor (CPI) combination in its “Spotlight” poster presentation session, at the 2024 San Antonio Breast Cancer Symposium® (SABCS®) held at Henry B. Gonzalez Convention Center, San Antonio, TX.

“In the Phase 2 study, the Bria-IMT™ combination regimen significantly increased overall survival versus comparable published benchmarks. Additionally, objective response rate and clinical benefit rate data, support the potential benefit of Bria-IMT™ plus CPI in patients with this difficult-to-treat cancer,” stated Saranya Chumsri, MD, Principal Investigator, and Professor of Oncology, Mayo Clinic. “We plan to confirm the impressive clinical data in the BriaCell pivotal Phase 3 study as we continue to explore the use of Bria-IMT™ regimen across all breast cancer subtypes.”

“At BriaCell, we are committed to finding therapeutic options for difficult-to-treat metastatic breast cancer patients,” stated Dr. William V. Williams, BriaCell’s President & CEO. “BriaCell’s clinical data demonstrating impressive overall survival in all patient subsets including very difficult to treat patient populations, such as those who have failed prior checkpoint inhibitor and/or antibody-drug conjugate therapy, reinforces our confidence in the potential use of the combination regimen in MBC patients. Additionally, clinical benefit was seen across metastatic breast cancer subtypes including HER2+, HR+/HER2-, and even in triple-negative breast cancer (TNBC) patients. Bria-IMT™ may provide a significant contribution to the lives of patients and their families fighting this incurable disease.”

The details about the submitted abstracts are as follows:

Abstract Number: SESS-1071 (Selected as Spotlight Poster)

Title: Overall survival results of Bria-IMT allogenic whole cell-based cancer vaccine
Time: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CST
Presentation ID: PS3-06

Abstract Summary:

  • 54 patients were enrolled with 22 patients in phase 1 and 32 patients in phase 2.
  • 11 patients were treated with pembrolizumab and 44 patients with retifanlimab (1 patient received pembrolizumab and later retifanlimab).
  • The Bria-IMT™ combination regimen was well tolerated.
  • The Bria-IMT™ regimen demonstrated promising results across all subtypes of breast cancer with favorable safety profiles.
  • Patients receiving the pivotal Phase 3 Bria-IMT™ combination regimen (n=37) showed significantly higher median overall survival (OS) (13.4), an objective response rate (ORR) of 9.5% and a clinical benefit rate (CBR) of 55%.
  • Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive.
  • Among 36 patients with post-dose cancer-associated circulating tumor cell (CTC) data, patients with post-dose CTC count < 5 had a significantly better OS compared with a CTC count > 5 (13.4 vs. 5.5 months, P 0.01).
  • Patients with positive delayed type hypersensitivity (DTH), an inflammatory marker to measure the response to Bria-IMT™ immunization, had significantly better OS.

“Our clinical findings support the use of the current Phase 3 formulation,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We plan to confirm the potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT™ plus CPI ongoing pivotal Phase 3 study (NCT06072612) in metastatic breast cancer.”

Abstract Number: SESS-1431
Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccines
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-06-02

Abstract Number: SESS-2217
Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysis
Time: Wednesday, December 11, 2024 12:00 – 2:00 PM CST
Presentation ID: P1-01-17

Abstract Number: SESS-1068
Abstract Title: ASTRO-VAC CNS: Bria-IMT in the management of tumor agnostic metastatic CNS lesions
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-10-24

Abstract Number: SESS-1069
Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn “Cold” tumor “Hot” in metastatic breast cancer
Time: Friday, December 13, 2024 12:00 PM – 2:00 PM CST
Presentation ID: P5-10-12

Following presentations, the posters can be viewed at the following: https://briacell.com/scientific-publications/.

About BriaCell Therapeutics Corp.

BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.

Safe Harbor

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about BriaCell’s potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT™ plus CPI ongoing pivotal Phase 3 study; BriaCell’s potential use of the combination regimen in MBC patients; BriaCell conducting a poster presentation at the 2024 San Antonio Breast Cancer Symposium®, and the contents of such presentation; the potential benefit of Bria-IMT™ plus CPI in cancer patients; BriaCell’s plans to confirm the clinical data in their pivotal Phase 3 study; BriaCell’s Phase 3 study exploring the use of the Bria-IMT™ regimen across all breast cancer subtypes; and the Bria-IMT™ regimen having the potential to provide a significant contribution to the lives of cancer patients are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements, such as those are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.

Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

Company Contact:

William V. Williams, MD
President & CEO
1-888-485-6340
[email protected] 

Media Relations:

Jules Abraham
CORE IR
[email protected]

Investor Relations Contact:

CORE IR
[email protected]



Posted on

Profound Medical to Unveil Next TULSA-AI® Module, ‘UA Alignment Assistant’

TULSA procedure’s unrivaled flexibility, real-world efficacy and ongoing CAPTAIN post-market study to be featured in the scientific programs at the upcoming RSNA and SUO meetings

TORONTO, Nov. 26, 2024 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, is pleased to announce the unveiling of its third TULSA-AI® software module, UA Alignment Assistant, in addition to six presentations featuring the Transurethral Ultrasound Ablation (“TULSA”) procedure, at the upcoming 110th Scientific Assembly and Annual Meeting of the Radiological Society of North America (“RSNA 2024”) being held in Chicago, IL, December 1-4, 2024, and the 25th Annual Meeting of the Society of Urologic Oncology (“SUO 2024”) taking place in Dallas, TX, December 4 – 6, 2024.

The TULSA procedure, performed using Profound’s TULSA-PRO® system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. TULSA employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine.

Recognizing TULSA is being used by urologists to treat an unrivalled variety of prostate cancer and/or BPH patients, Profound is developing a novel set of software modules under the TULSA-AI® brand to work in conjunction with TULSA-PRO® to provide further customizability, ease of use, speed of treatment and higher confidence in clinical outcomes.

As the name implies, UA Alignment Assistant streamlines the alignment of the ultrasound applicator (“UA”) catheter that resides in the center of the prostate during the TULSA procedure. The primary benefit of the software is improvement in workflow consistency, as instead of aligning it manually, it will now be done the same way every time via the module. Previously, the manual TULSA-PRO® UA alignment meant that users had to spend time scrolling through MR images and clicking through to align them to the UA. Via the new software, MR images will be automatically imported and then immediately displayed to the user in an aligned way.

“One of the focusses of RSNA 2024 – which is expected to attract more than 40,000 physicians, researchers and industry participants – will be on the increasingly important role that AI can play in improving the efficiency and quality of care,” said Arun Menawat, Profound’s CEO and Chairman. “Accordingly, it is the ideal forum for us to unveil for the first time our third TULSA-AI® module, UA Alignment Assistant. Effectively, the module removes a whole procedural step from TULSA, resulting in less mental charge, fewer steps to remember, and overall procedural simplification for users. We are also excited to see that the RSNA and SOU 2024 meetings will feature presentations on the TULSA procedure by esteemed physicians and researchers from the Busch Center, UT Southwestern Medical Center and the Mayo Clinic.”


Presentation details:


RSNA 2024

  • Customized Whole-Gland MR-Guided Transurethral Ultrasound Ablation (TULSA) for the Treatment of Localized Prostate Cancer: A Single Centre Retrospective of 73 Patients

    Joseph J. Busch, MD
    Busch Center (Alpharetta, GA)
    December 4, 2024; 9:00-9:30 p.m. CST
  • Real-World Efficacy of MRI-Guided Transurethral Ultrasound Ablation of the Prostate: Initial Report from the Customized Ablation Registry (CARE)

    Daniel N. Costa, MD
    UT Southwestern Medical Center (Dallas, TX)
    December 4, 2024; 12:45-1:15 p.m. CST


SOU 2024

  • Real-World Efficacy of MRI-Guided Transurethral Ultrasound Ablation of the Prostate: Initial Report from the Customized Ablation Registry (CARE)

    Chandler Dora, MD
    Mayo Clinic (Jacksonville, FL)
    December 5, 2024; 4:15-5:15 p.m. CST
  • Post-Operative Sentiment in Patients After MRI-Guided Transurethral Ablation (TULSA) of Localized Prostate Cancer: Quantifiying Regret and Correlating Patient-Reported Regret with Functional Outcomes

    Andrew Murphy
    UT Southwestern Medical Center (Dallas, TX)
    December 6, 2024; 9:00-10:00 a.m. CST
  • MRI-Guided Transurethral Ultrasound Ablation (TULSA) of Localized Prostate Cancer: Single Institution Experience of Treatment Efficacy

    Emily Bochner, MD
    UT Southwestern Medical Center (Dallas, TX)
    December 6, 2024; 9:00-10:00 a.m. CST
  • CAPTAIN Randomized Controlled Trial of TULSA Against Radical Prostatectomy for Intermediate-Risk Prostate Cancer: Design and Recruitment Update

    Xiaosong Meng, MD, PhD
    UT Southwestern Medical Center (Dallas, TX)
    December 6, 2024; 9:00-10:00 a.m. CST

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA procedure, performed using the TULSA-PRO® system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. TULSA employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO® is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).

Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. The Company is in the early stages of exploring additional potential treatment markets for Sonalleve® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.


Forward-Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; and the success of Profound’s U.S. commercialization strategy and activities for TULSA-PRO

®

. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
[email protected]
T: 647.872.4849

Susan Thomas
Public Relations
[email protected]
T: 619.540.9195



Posted on

EVLV STOCK REPORT: Suffer Losses on Your Evolv Technologies Investment? Contact BFA Law about its Pending Class Action Lawsuit (Nasdaq:EVLV)

NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that it has filed a lawsuit against Evolv Technologies Holdings, Inc. (NASDAQ: EVLV) and certain of the Company’s current and former senior executives.

If you invested in Evolv, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/evolv-technologies-holdings-inc.

Investors have until December 31, 2024 to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in Evolv’s securities.   The case is pending in the U.S. District Court for the District of Massachusetts and is captioned Buchan v. Evolv Technologies Holdings, Inc., No. 1:24-cv-12768. A copy of the lawsuit can be found here: https://www.bfalaw.com/siteFiles/Cases/EvolvFiledComplaint.pdf

What is the Lawsuit About?

Evolv is a security technology company that utilizes AI-based screening designed to help create safer experiences. The complaint alleges that Evolv’s financial statements prepared for the periods between the second quarter of 2022 and the second quarter of 2024 contained material misstatements relating to Evolv’s revenue recognition and other reported metrics that are a function of revenue.

On October 25, 2024, Evolv announced that the Company’s financial statements issued between the second quarter of 2022 and the second quarter of 2024 should not be relied upon due to material misstatements impacting revenue recognition and other previously reported metrics that are a function of revenue. The Company revealed that certain sales, including sales to one of its largest channel partners, were subject to extra-contractual terms and conditions not shared with the Company’s accounting personnel and that certain Company personnel engaged in misconduct in connection with those transactions. The Company also announced that it has self-reported these issues to the Division of Enforcement of the Securities and Exchange Commission and was delaying filing its upcoming quarterly report for the third quarter of 2024. On this news, the price of Evolv stock declined roughly 40%, from $4.10 per share on October 24, 2024, to $2.47 per share on October 25, 2024.

Then, on October 31, 2024, Evolv announced the termination of the Company’s CEO, Peter George, effective immediately. The Company announced that Michael Ellenbogen, Evolv’s Chief Innovation Officer will serve in an interim role until a successor is appointed. On this news, the price of Evolv stock declined roughly 8%, from $2.34 per share on October 30, 2024, to $2.15 per share on October 31, 2024.

Click here for more information:

https://www.bfalaw.com/cases-investigations/evolv-technologies-holdings-inc

.

What Can You Do?

If you invested in Evolv you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.

Submit your information by visiting:


https://www.bfalaw.com/cases-investigations/evolv-technologies-holdings-inc

Or contact:
Ross Shikowitz
[email protected]
212-789-3619

Why Bleichmar Fonti & Auld LLP?

Bleichmar Fonti & Auld LLP is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs’ Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.’s Board of Directors (pending court approval), as well as $420 million from Teva Pharmaceutical Ind. Ltd.

For more information about BFA and its attorneys, please visit https://www.bfalaw.com.


https://www.bfalaw.com/cases-investigations/evolv-technologies-holdings-inc

Attorney advertising. Past results do not guarantee future outcomes.



Posted on

DocGo’s EMS Direct Signs Two-Year Contract to Provide Medical Transportation for a Leading Health and Hospital System in Fort Worth

DocGo’s EMS Direct Signs Two-Year Contract to Provide Medical Transportation for a Leading Health and Hospital System in Fort Worth

NEW YORK–(BUSINESS WIRE)–
DocGo Inc. (Nasdaq: DCGO) (“DocGo” or the “Company”), a leading provider of technology-enabled mobile health services, today announced a new contract for ambulance transport services with one of the largest health and hospital systems in North Texas.

Under this contract, DocGo’s subsidiary EMS Direct is providing Basic Life Support, Advanced Life Support, and Critical Care transportation services to Fort Worth facilities. This agreement was signed and operationalized in less than 90 days — underscoring DocGo’s agility and responsiveness to the healthcare system’s needs.

“Our ability to scale quickly and effectively is one of our key competitive differentiators,” said Lee Bienstock, CEO of DocGo. “Our services will help ensure Fort Worth and the surrounding areas have access to top-tier medical transportation services when they’re needed, and this contract positions us to invest for additional growth in the Dallas area.”

DocGo’s EMS Direct proudly serves communities across Texas, and this new agreement reflects the Company’s commitment to delivering high-quality healthcare solutions in the Lone Star State – providing patients in Fort Worth and the surrounding areas with greater access to reliable medical transportation services.

About DocGo

DocGo is leading the proactive healthcare revolution with an innovative care delivery platform that includes mobile health services, remote patient monitoring and ambulance services. DocGo is helping to reshape the traditional four-wall healthcare system by providing high quality, highly accessible care to patients where and when they need it. DocGo’s proprietary technology and relationships with a dedicated field staff of certified health professionals elevate the quality of patient care and drive business efficiencies for facilities, hospital networks and health insurance providers. With Mobile Health, DocGo empowers the full promise and potential of telehealth by facilitating healthcare treatment, in tandem with a remote physician, in the comfort of a patient’s home or workplace. Together with DocGo’s integrated Ambulnz medical transport services, DocGo is bridging the gap between physical and virtual care. For more information, please visit www.docgo.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things, the Company’s plans, strategies, outcomes, and prospects, both business and financial, of the Company, including the provision of services in the Texas market. These statements are based on the beliefs and assumptions of the Company’s management. Although the Company believes that its plans, intentions and expectations reflected in or suggested by these forward-looking statements are reasonable, the Company cannot assure you that it will achieve or realize these plans, intentions, outcomes, results or expectations. Accordingly, you should not place undue reliance on such statements. All statements other than statements of historical fact are forward-looking. In some cases, these statements may be preceded by, followed by or include the words “believes,” “estimates,” “expects,” “projects,” “forecasts,” “may,” “might,” “will,” “should,” “could,” “can,” “would,” “design,” “potential,” “seeks,” “plans,” “scheduled,” “anticipates,” “intends” or the negative of these terms or similar expressions. Forward-looking statements are inherently subject to substantial risks, uncertainties and assumptions, many of which are beyond the Company’s control, and which may cause the Company’s actual results or outcomes, or the timing of results or outcomes, to differ materially from those contained in the Company’s forward-looking statements, including, but not limited to the following: the Company’s ability to successfully implement its business strategy, including with respect to the provision of services in Texas; the Company’s reliance on and ability to maintain its contractual relationships with its healthcare provider partners and clients; the Company’s ability to compete effectively in a highly competitive industry; the Company’s ability to maintain existing contracts, including its new contract to serve facilities in Fort Worth; the Company’s reliance on government contracts; the Company’s ability to effectively manage its growth; the Company’s financial performance and future prospects; the Company’s ability to deliver on its business strategies or models, plans and goals; the Company’s ability to expand geographically; the Company’s competitive position and opportunities, including its ability to realize the benefits from its operating model; and other risk factors included in the Company’s filings with the Securities and Exchange Commission. The forward-looking statements made in this press release are based on events or circumstances as of the date on which the statements are made. The Company undertakes no obligation to update any forward-looking statements made in this press release to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as and to the extent required by law.

Media:

Tommy Meara

Moxie Strategies

718-309-3506

[email protected]

Investors:

Mike Cole

DocGo

949-444-1341

[email protected]

[email protected]

KEYWORDS: Texas New York United States North America

INDUSTRY KEYWORDS: Health Telemedicine/Virtual Medicine Transport Hospitals Other Health General Health Other Transport

MEDIA:

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