University of Pittsburgh Medical Center

Pancreatic Cancer Program - Pancreatic cancer Phase 2 trial of onvansertib + SoC in the second-line setting demonstrated greater efficacy vs. historical controls with ORR of 19% (vs. 7.7%) and mPFS of 5.0 months (vs. 3.1 months) - - Pancreatic cancer biomarker discovery trial in refractory patients demonstrated tumor biomarker response to onvansertib treatment as a single-agent - - Based on positive data from both pancreatic trials and supportive preclinical data, a first-line pancreatic investigator-initiated trial is planned to evaluate the efficacy of onvansertib + SoC - Small Cell Lung Cancer Program - Preliminary data from small cell lung cancer Phase 2 trial in refractory patients with extensive stage disease demonstrate single-agent activity from onvansertib monotherapy - - Company will hold a conference call today at 5:00 p.m. ET/2:00 p.m. PT - SAN DIEGO, Sept. 26, 2023 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced positive clinical data with onvansertib monotherapy and combination therapy in our ongoing trials in metastatic pancreatic ductal adenocarcinoma (mPDAC) and small cell lung cancer (SCLC), as well as plans for a mPDAC first-line investigator-initiated trial (IIT) of the combination of onvansertib plus standard-of-care (SoC). "We are excited that the data released from these trials, in two challenging cancers with low survival rates, expands the opportunity for onvansertib beyond our lead program in RAS-mutated mCRC," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "In pancreatic cancer, the strength of the data provides a clear rationale for a first-line trial using onvansertib in combination with standard of care, which we believe provides the greatest opportunity for a positive impact on patients. In small cell lung cancer, we are encouraged to observe single-agent activity with onvansertib monotherapy in this difficult-to-treat extensive stage refractory setting." mPDAC Phase 2 CRDF-001 trial: 19% ORR and 5.0-month mPFS Data from the ongoing Phase 2 open-label trial of onvansertib combined with nanoliposomal irinotecan, leucovorin, and 5-FU in patients with second-line mPDAC demonstrated an objective response rate (ORR) of 19% (4 of 21 evaluable patients; 1 confirmed PR, 3 waiting for confirmatory scan) and median progression-free survival (mPFS) of 5.0 months as of the data cutoff of September 13, 2023. Historical control trials in similar patient populations have shown an ORR of 7.7% and mPFS of 3.1 months with SoC. mPDAC biomarker discovery trial: decrease in clinically-validated tumor biomarkers from onvansertib monotherapy The investigator-initiated biomarker discovery trial is exploring the impact of onvansertib 10-day monotherapy on tumors in mPDAC patients, and is currently enrolling at the Oregon Health & Science University (OHSU) Knight Cancer Institute. Two patients have been enrolled to date. One patient demonstrated an 86% decrease in Ki67, a well-established biomarker of tumor proliferation, and a 28% decrease in CA 19-9, a clinically-used biomarker to monitor treatment response. "Serum carbohydrate antigen 19-9 is the most extensively studied and validated serum biomarker in PDAC, which provides a clinically meaningful surrogate for response to treatment. We are encouraged by the ability of onvansertib to provide an approximately 30% reduction in this biomarker with only 10 days of monotherapy in a refractory setting," said Fairooz Kabbinavar, MD, Chief Medical Officer of Cardiff Oncology. "We will continue to explore onvansertib in the first-line mPDAC investigator-initiated trial at the OHSU Knight Cancer Institute." Update in Clinical Development Plan for mPDAC The next trial in mPDAC will be a new Phase 2 investigator-initiated trial at OHSU Knight Cancer Institute in mPDAC in the first-line setting. There are two cohorts in this trial. In cohort 1, patients will receive the combination of onvansertib with SoC (Gemzar + Abraxane). In cohort 2, patients will receive 10 days of onvansertib monotherapy followed by onvansertib + SoC to identify biomarkers that predict response to onvansertib. SCLC Phase 2 Investigator-Initiated Trial The ongoing Phase 2 trial of onvansertib monotherapy in patients with relapsed extensive stage SCLC who have received up to two prior therapies is currently enrolling patients at the University of Pittsburgh Medical Center. An examination of the safety data from the first six patients by the institutional review board confirmed the trial can continue to enroll as planned. Preliminary efficacy data in evaluable patients will be discussed on the company conference call. Conference Call and Webcast Cardiff Oncology will host a corresponding conference call and live webcast at 5:00 p.m. ET/2:00 p.m. PT on September 26, 2023. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company's website at . A webcast replay will be available in the investor relations section on the company's website for 30 days following the completion of the call. About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit . Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Cardiff Oncology Contact: James Levine Chief Financial Officer 858-952-7670 [email protected] Investor Contact: Kiki Patel, PharmD Gilmartin Group 332-895-3225 [email protected] Media Contact: Richa Kumari Taft Communications 551-344-5592 [email protected] SOURCE Cardiff Oncology, Inc.

Starlight's new Virtual Reality headset is taking the benefits of VR even further for patients in the hospital LOS ANGELES, Sept. 22, 2023 /PRNewswire/ -- Starlight Children's Foundation, a nonprofit dedicated to delivering happiness to hospitalized kids and their families, is thrilled to announce the new iteration of the Starlight Virtual Reality (VR) program Introduced in 2018, Starlight VR transforms the hospital experiences for kids, providing a positive distraction and in some cases reducing the need for pain medication when immersed in a virtual experience. The newest iteration of the Starlight VR headset provides inclusivity, entertainment, and endless possibilities for children of all ages. For 18-year-old Amanda, Starlight Virtual Reality program was a major help to her when through treatment and recovery. She was suddenly diagnosed with acute myeloid leukemia and hospitalized to begin treatment in 2020, her family was shocked. She required intense treatment. "It just took me to another world and let me be somewhere completely different," Amanda told us. "Because I wasn't thinking about everything that was happening and my body was just calmer." The updated version is wipeable, wireless and can be used anywhere, with or without Wi-Fi. With hands-free capabilities, patients with limited mobility can control their experience through eye movement or voice commands, so that every child can take control of their virtual adventure, making it accessible to all pediatric patients. VR experiences include tools for cognitive stimulation, relaxation therapy, mindfulness and more. Each session offers an opportunity for healing and growth. Adam Garone, CEO of Starlight Children's Foundation, said, "We're thrilled to introduce our updated VR program to help provide hospitalized kids with a positive distraction that transports them out of their hospital room and into a virtual world, where they experience some joy and comfort while coping with challenging procedures and treatments. The integration of gaze control and voice control technologies is a groundbreaking advancement, promoting inclusivity and equity for all patients with diverse abilities and needs, who may benefit from VR." Starlight's VR program has impacted many pediatric units by helping kids relax during difficult medical procedures, distract from pain, aid in physical therapy and recovery, and in some cases even replace the need for general anesthesia! "Starlight VR has had a major impact on our patients!" said Renee Provost, program coordinator at A Rosie Place Children's Hospital. "It has brought them joy, has helped calm them if needed, and has created a positive experience for them. It's taken away from their boredom here at the facility and has given them something to look forward to. When their time is up and we move on to the next activity, they want to come back to Starlight VR, and that is a gift, especially for our nonverbal patients." These VR Headsets are critical for child life teams who play an essential role in the care of pediatric patients, If you would like to transform hospital experiences of young patients in your community, you can donate headsets to your local children's hospital, by visiting the Starlight donation page starlight.org/impact. About Starlight Children's Foundation No matter the length, hospital stays can be lonely, stressful, and scary. That's why Starlight exists. Founded in 1982, Starlight Children's Foundation is a 501(c)3 organization that aims to deliver happiness to hospitalized children and their families. Carefully crafted to address the unique needs of pediatric patients, Starlight's vital programs – including Starlight Gaming, Starlight Virtual Reality, Hospital Gowns, and Starlight Toy Deliveries – are donor-funded and offered free of charge to hospitals within its nationwide network to provide comfort, distraction, and a sense of normalcy to kids coping with hospitalization, procedures and treatments. The impact of these programs reaches even further to the families and caregivers, creating a supportive community that nurtures kids when they need it most. To learn more and to help Starlight deliver happiness to hospitalized kids, visit and follow Starlight on Facebook, Instagram, and Twitter. SOURCE Starlight Children’s Foundation

Market Leader Now Live at 22 Health Systems Nationwide, Expects to Triple Customer Footprint Over Next 24 Months AUSTIN, Texas, Sept. 21, 2023 /PRNewswire/ -- Diligent Robotics, the undisputed leader in robotic automation in health care, today announced $25 million in new financing led by Canaan, with True Ventures, DNX Ventures, Next Coast Ventures among the return investors and Northwestern Medicine Innovation joining as a new strategic investor. Rich Boyle from Canaan will join the board of directors. The company will use the funds to fuel system-wide expansions of its revolutionary Moxi robot across hospitals nationwide, enhance product development and triple its market reach. Continue Reading Caption: Dr. Andrea Thomaz and Dr. Vivian Chu from Diligent Robotics with Moxi, the first and only socially-intelligent robot teammate in the field today who works across health systems to improve operational efficiency of hospital care teams so they have more time for patient care and can practice at the top of their license. "The incredible demand we've seen for Moxi is a testament to the clear value of using robotic automation to augment and support frontline hospital care teams, but also our highly customer-centric approach to bringing new technology and operational change into healthcare," said Andrea Thomaz, Ph.D., Diligent Robotics' co-founder and CEO. "We approach our work with deep empathy for the people who care for patients every day, and it has been incredible to witness the difference Moxi makes in supporting nursing, pharmacy, lab and entire clinical care teams. This funding round will enable us to scale fleets and accelerate product development while remaining true to our vision of creating robots that function as core team members and elevate the standards of healthcare through robotics." Diligent Robotics is the creator of Moxi, the first and only socially-intelligent robot teammate in the field today who works across health systems to improve operational efficiency of hospital care teams so they have more time for patient care and can practice at the top of their license. Founded by Dr. Andrea Thomaz and Dr. Vivian Chu, Diligent Robotics' state-of-the-art robotics technology enables robots to collaborate within and adapt to human environments. Moxi's impact includes augmenting staff and care teams by off-loading hospital-wide deliveries of supplies, equipment, medication and lab deliveries and is increasingly enabling new and existing high value programs to efficiently scale, such as Meds to Beds programs, Just in Time Logistics and Virtual Nursing. Currently adopted by and operating in more than 22 health systems that represent more than 200 hospitals nationwide, including NorthShore – Edward-Elmhurst Health, MultiCare Health System, The University of Texas affiliated network of health systems, Northwestern Medicine and many others, the company expects to triple its market footprint over the next 24 months, including systemwide expansion within the majority of the health systems. "As an organization driven by our Patients First mission, we continue to explore ways innovation and technology can support our clinicians and staff to enhance their ability to care for our patients," said Doug King, senior vice president and chief information officer at Northwestern Medicine. "Led by our team at the Northwestern Medicine Mansueto Innovation Institute, we deployed Moxi in targeted areas throughout Northwestern Memorial Hospital to support clinical staff by automating and scheduling pickups of non-tubable lab specimens and medications. Introducing this technology had a positive impact on staff and workflow. We are looking forward to deploying Moxi throughout our health system in the near future." Diligent Robotics Surpasses Customer, Manufacturing Milestones, Autonomy Metrics This round of funding comes on the heels of a record year for Diligent Robotics, as the company has continued to make significant progress across product development, customer implementation strategy and manufacturing capacity. The company has inked new strategic partnerships and collaborations with leading healthcare institutions and scaled manufacturing. Diligent has also refined a quality assurance process that enables the building of multiple robots in various stages of production, increasing manufacturing capacity which has led to a reduced deployment window for Moxi. On average, services are live in less than 30 days from robot arrival. Diligent Robotics also surpassed many impressive autonomy metrics including the completion of more than 400,000 total deliveries giving more than 200,000 hours back to staff to instead spend with patients. Utilizing their state-of-the-art mobile manipulation approach for human environments, Moxi robots have autonomously opened hundreds of thousands of doors over the past year and in the last month alone, Moxi has autonomously navigated elevators tens of thousands of times. Of note, Children's Hospital Los Angeles was the first children's hospital to implement Moxi. There are two Moxi robots delivering medications and pharmaceutical items 24/7 along various routes throughout the hospital. In just over four months, Moxi has made more than 2,500 deliveries, traveled 132 miles, and saved staff more than 383,000 steps and 1,620 hours of work time. Diligent Robotics has signed on several children's hospitals in recent months and expects to increase its market share even further among children's hospitals in 2024. "With healthcare staffing needs continuing to exceed the labor available, hospitals must make the best use of their constrained workforces to meet demand. That means finding new efficiencies in previously unaddressable areas and offering staff members a return to their most fulfilling work," said Rich Boyle, general partner at Canaan. "Moxi has already been eagerly adopted by many of the nation's top healthcare systems, and the positive impact on productivity, patient outcomes, and team morale is evident. Both are reasons we believe Diligent Robotics has a big future and are thrilled to be leading this newest round of financing." Contact Christy Warring, Diligent Robotics 281-684-3184 | [email protected] SOURCE Diligent Robotics