The 9 Most Dangerous Foods for Dogs—And the Ones You Can Safely Swap In
As much as we might love to share with our dogs, certain foods are just not good for them at all, no matter how you slice it. There are some foods that are toxic in small amounts, some that are dangerous only if given in larger amounts and some that we aren't even sure how toxic they are.The following are nine of the most dangerous foods you can give to your dogs, plus some safe and healthy alternatives.No toxic dose has even been determined. We do know there's a toxic compound, which is, as of yet, unidentified and possibly not present in all grapes, but some compound in the fruit can cause kidney failure in dogs.Dogs suffer from vomiting and diarrhea when they eat grapes, and no specific cure is available, so they just need to be avoided. Raisins can also be just as toxic, and it's safer to avoid all members of that fruit family (currants, for example).
This artificial sweetener, also known as xylitol, is toxic. One problem is that it's present in some foods and medications for humans and isn't even listed in the ingredients. Many products like ice cream and other human treats contain xylitol.A second problem is that it can appear as something different on the label since the traditional name, xylitol, sounds so artificial.
The problem with onions is that they have a cumulative effect, so even if only a small dose is given every day, the red blood cells that are affected will eventually cause anemia and can kill your dog. A higher dose will cause vomiting and diarrhea, and the red blood cell damage can cause organ failure and death.
The main problem is the fat levels in these nuts. Dogs may develop pancreatitis from them, just like they do after eating a lot of chicken skin, fat trimmings or a bowl of drippings from the Thanksgiving turkey.The toxic dose for macadamia nuts is quite small, but like all toxins, it's related to the dog's body weight. A tiny dog like a Maltese or Chihuahua could develop pancreatitis after eating only a few nuts. Larger dogs would take a lot more to develop symptoms, but these and other fatty nuts should never be given to any dogs.
The chemicals found in cocoa (theobromine and some others) are toxic to dogs. Cocoa beans are bitter, and not many dogs would even eat them if given the chance, but the problem is that if dogs see us eating a treat, like raisins covered in dark chocolate, they will sit and beg.If they eat them and only vomit or have diarrhea, they'll probably be fine, but theobromine can also cause seizures, fast heart rates and even death.
When bones are cooked, they become hard and brittle. There's an immediate choking hazard, and if the bone is swallowed, it can perforate the esophagus, stomach or intestine. Cooked bones are also more likely to cause constipation, so if your dog is straining, this can be a cause.
The effects of alcohol are more visible in dogs because of their metabolism and smaller body weight, and if you leave a drink down, they're likely to investigate and drink it, especially a mixed drink that has sweeteners.Smaller amounts will cause vomiting and diarrhea, but larger amounts will cause tremors, lethargy and seizures, so if your dog is exposed, they should be examined. Be sure to take the mixer you used to the vet so that any artificial sweeteners that might have been added can be evaluated.
If your dog has coffee, the toxin is caffeine. In some cases, it can be fatal, and since dogs are a lot more sensitive than we are, one cup of coffee could be all it takes. It can cause hyperexcitement, tremors and even seizures, and if your coffee had milk and sugar added, vomiting and diarrhea are even more likely.
Despite their toxicity, edibles aren't listed on most sites as being toxic to dogs. They should be. Dogs aren't likely to eat much hash or raw pot, as it tastes bad, but edibles are a different category. As marijuana becomes decriminalized in more states, these are more common than they used to be and are more likely to be left out where dogs can find them.Dogs have more cannabinoid receptors than humans, and edibles may also contain xylitol, chocolate or caffeine. THC, the psychoactive compound that's concentrated in the edibles, causes severe health problems in dogs, including vomiting, diarrhea, seizures and coma. It can be lethal at high doses.
Dogs like to find things you leave lying around and like to chew anything, whether edible or not. If you like to snack, there's certainly nothing wrong with giving your dog something at the same time, as long as you consider the additional calories.Some of the alternative snacks you can give your dog include:
Vegetables: Many dogs like pumpkin, so you can use canned pumpkin (not pumpkin pie mix, as it contains spices) and cut it up into smaller chunks. I find that many dogs like them lightly salted. You can also use carrot slices, green beans (chopped up into quarter-inch pieces) or small pieces of sliced sweet potato.
Fruit: Good options include apple slices (a good source of fiber and many vitamins), blueberries (an excellent source of antioxidants), raspberries, strawberries, banana slices or even watermelon, although I do find it kind of sloppy if feeding by hand.
Meat: This can be kind of messy as an alternative treat, but there are several companies that sell chicken hearts and chicken liver as freeze-dried treats. An inexpensive option is beef liver, which can be sliced into small chunks and then cooked in an air fryer for a few minutes until it's dry and easy to handle.
Eggs: I usually include eggs in the regular meal plan, but boiled and sliced eggs are also a great treat. My main problem with this is that my dogs love them, and they usually eat them even faster than the other treats.
Please keep in mind that all of these treats contain calories and, if given in excess, will eventually make your dog overweight or obese. Whole-food treats can be a great addition to the diet if you want to get away from ultra-processed dry dog foods, but like all things, they need to be given in moderation.Up Next:Fitzgerald KT, Bronstein AC, Newquist KL. Marijuana poisoning. Top Companion Anim Med. 2013 Feb;28(1):8-12. doi: 10.1053/j.tcam.2013.03.004. PMID: 23796481. https://pubmed.ncbi.nlm.nih.gov/23796481/
The 9 Most Dangerous Foods for Dogs—And the Ones You Can Safely Swap In first appeared on Parade Pets on Jul 6, 2025
This story was originally reported by Parade Pets on Jul 6, 2025, where it first appeared.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
26 minutes ago
- Yahoo
Tyra Biosciences Doses First Patient in Phase 2 Study of TYRA-300 in Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)
-TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC- -Initial 3-month complete response (CR) data expected to be reported in 1H 2026- CARLSBAD, Calif., June 30, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today that the first patient has been dosed in the Phase 2 SURF302 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC). TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to minimize the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for FGFR3 gatekeeper mutations. FGFR3 is a frequently altered gene in IR NMIBC, with ~70% of low-grade IR NMIBC showing activating mutations. "Our goal is to develop TYRA-300 as the first once-daily oral treatment designed to reduce disease recurrence, as well as surgical procedural intervention and intravesical therapy, for people living with IR NMIBC," said Dr. Erik Goluboff, SVP of Clinical Development at TYRA. "We believe we are well-positioned to contribute meaningful advancements to the field of bladder cancer with SURF302, and we anticipate that the clinical data will offer valuable insights with the potential to enhance patient outcomes." SURF302 (NCT06995677) is an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with TYRA-300 at 50 mg once daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability. "I am excited that the Phase 2 trial evaluating oral TYRA-300 in IR NMIBC is now underway," said Dr. Tom Jayram, Director of the Advanced Therapeutics Center at Urology Associates in Nashville, TN. "IR NMIBC is a challenging disease for urologists and patients alike, with the potential for recurrence, progression, and the morbidity of multiple procedures for disease surveillance. Selective FGFR inhibitors are an exciting new option in this disease space that can allow a personalized approach to bladder cancer. TYRA-300 is an investigational, daily oral tablet that has shown encouraging preliminary safety and efficacy in an early phase trial and has the potential to be a paradigm shift in how urologists can treat bladder cancer." TYRA-300 will also be evaluated in pediatric achondroplasia in the BEACH301 Phase 2 study, which is open for enrollment and for which the Company now expects first child dosing in the second half of the year. About Non-Muscle Invasive Bladder Cancer In the United States, it is estimated that there are more than 730,000 people living with bladder cancer. Many of these patients have intermediate risk non-muscle invasive bladder cancer (IR NMIBC) and experience recurrence episodes throughout the course of their disease. Treatment for IR NMIBC and disease recurrence is a surgical procedure called transurethral resection of bladder tumor (TURBT) combined with intravesical-administered chemotherapy. Repeat TURBT procedures and intravesical-administered chemotherapy can impact patients' quality of life and overall health, leading to a significant unmet medical need for better tolerated therapeutic options. TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC. About TYRA-300 TYRA-300 is the Company's lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasia that has demonstrated interim clinical proof-of-concept results in metastatic urothelial cancer (mUC). TYRA-300's planned clinical development includes three Phase 2 clinical trials: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for mUC. Please visit the Patients page of our website for more information on our clinical trials. About Tyra Biosciences Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in FGFR biology. The Company's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. TYRA's expertise in FGFR biology has created a differentiated pipeline with three clinical-stage programs in targeted oncology and genetically defined conditions. The Company's lead precision medicine stemming from SNÅP, TYRA-300, is a potential first-in-class selective FGFR3 inhibitor that is designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for FGFR3 gatekeeper mutations. TYRA-300's planned clinical development includes three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for metastatic urothelial cancer. TYRA is also developing TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma, and TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit and engage with us on LinkedIn. Forward-Looking Statements TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: expected reporting of data from the SURF302 study and the timing thereof; the design and goals of the SURF302 study; the potential to develop next-generation precision medicines and for TYRA-300 to be a first-in-class, once-daily oral treatment, and the potential safety and therapeutic benefits of TYRA-300; the expected timing and phase of development of TYRA-300, including the expected timing of dosing for the BEACH301 study in pediatric achondroplasia; and the potential for SNÅP to develop therapies. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: potential delays in the commencement, recruitment, enrollment, data readouts and completion of clinical trials and preclinical studies; results from preclinical studies or early clinical trials not necessarily being predictive of future results; interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of TYRA-300; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; our dependence on third parties in connection with manufacturing, research and preclinical testing; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for TYRA-300 or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; unfavorable results from preclinical studies; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Amy Conrad aconrad@ View original content to download multimedia: SOURCE Tyra Biosciences Sign in to access your portfolio
Yahoo
27 minutes ago
- Yahoo
ProKidney Reports Statistically and Clinically Significant Topline Results for the Phase 2 REGEN-007 Trial Evaluating Rilparencel in Patients with Chronic Kidney Disease and Diabetes
Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology 2025 Kidney Week as a late-breaking clinical trial In Group 1 (n=24), kidney function stabilized in patients randomized to receive two rilparencel injections (one in each kidney). The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference was statistically significant (p<0.001) and clinically meaningful In Group 2 (n=25), patients were randomized to receive a single rilparencel injection followed by a second injection only if kidney function worsened and a re-dosing trigger was met. The annual decline in eGFR slope improved by 50% from -3.4 mL/min/1.73m2 in the pre-injection period to -1.7 mL/min/1.73m2 in the period following the last rilparencel injection. This 1.7 mL/min/1.73m2 per year difference was not statistically significant (p=0.085) but suggests evidence of a dose response No rilparencel-related serious adverse events were observed; the safety profile was consistent with previously reported study results and comparable to a kidney biopsy FDA Type B meeting set for this summer to confirm ProKidney's approach to using eGFR slope as the surrogate endpoint in the ongoing Phase 3 PROACT 1 study for accelerated approval WINSTON-SALEM, N.C., July 08, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) ('ProKidney' or the 'Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today reported statistically significant and clinically meaningful positive topline results from the full Group 1 modified intent-to-treat (mITT) population of the Phase 2 REGEN-007 trial evaluating rilparencel in patients with CKD and diabetes. Rilparencel is an autologous cellular therapy that has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food & Drug Administration (FDA) and is currently being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) trial to demonstrate the therapy's potential to preserve kidney function in patients with advanced CKD and type 2 diabetes. 'We are very encouraged by the REGEN-007 topline results that demonstrated a robust improvement in eGFR slope following treatment with rilparencel in Group 1 as well as evidence of a dose response in Group 2. These data bolster our confidence in the design of our ongoing Phase 3 PROACT 1 study given the similarity between the dosing regimen in REGEN-007 Group 1 and PROACT 1. It is also worth noting that 15 of the 24 patients in Group 1 (63%) met key Phase 3 PROACT 1 inclusion criteria, and similar efficacy results were observed in this subgroup compared to the full Group 1 results. We plan to submit the full results from REGEN-007 to ASN's 2025 Kidney Week as a late-breaking clinical trial and are excited to share more details at that time with investors and the medical community,' said Bruce Culleton, M.D., CEO of ProKidney. 'We also look forward to our upcoming FDA Type B meeting in the coming weeks to confirm our approach to eGFR slope as a surrogate endpoint for accelerated approval. This meeting represents an important step toward our goal of expediting rilparencel's potential path to market in the U.S. where there remains a significant unmet clinical need in patients with advanced CKD and diabetes.' Phase 2 REGEN-007 Overview and Topline ResultsREGEN-007 is a multi-center Phase 2 open-label 1:1 randomized two-arm trial in patients with diabetes, CKD, and an estimated glomerular filtration rate (eGFR) of 20-50 mL/min/1.73m². At randomization, patients were assigned to one of two treatment groups using different dosing regimens. Group 1 replicated the dosing schedule of the ongoing Phase 3 PROACT 1 study in which patients received two scheduled rilparencel injections (one in each kidney), approximately three months apart. Group 2 tested an exploratory dosing regimen to investigate whether disease progression triggers, rather than a time-based trigger, could optimize multiple administrations of rilparencel. In Group 2, patients received a single rilparencel injection in one kidney and a second injection in the contralateral kidney only if triggered by a sustained eGFR decline from baseline of ≥ 20%, and/or an increase in the urine albumin to creatinine ratio (UACR) from baseline of ≥ 30% and ≥ 30 mg/g. The prespecified primary endpoint for REGEN-007 is the difference in annual eGFR slope (calculated using a linear mixed effects model) in the pre-injection period versus the period following the last rilparencel injection. The pre-injection period included all historical eGFR values collected up to 24 months before the screening visit as well as the on-study central laboratory eGFR results prior to first rilparencel injection. The period following the last injection included eGFR values from the last rilparencel injection to the end of study (EOS) visit. Median follow-up after the last injection was approximately 18 months in both Group 1 and Group 2. Fifty-three patients were randomized in the study, of whom 49 patients (mITT population) received at least one rilparencel injection. Four patients did not receive any rilparencel injections. The majority of patients were male (69%), and the mean age was 60 years. At baseline, 38 of 49 patients (78%) had type 2 diabetes mellitus and 11 (22%) had type 1 diabetes. Thirty-nine (80%) patients were receiving an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), and 18 (37%) were receiving a sodium-glucose cotransporter-2 inhibitor (SGLT2i). At baseline, the mean (SD) eGFR was 33±10 mL/min/1.73m2. Notably, the median UACR was higher in Group 1 (792 mg/g) compared to Group 2 (229 mg/g). Annual eGFR Slope (mL/min/1.73m2) Group N (mITT) Pre inj Post last inj Absolute benefit Relative benefit 1 24 -5.8 -1.3 4.6 78% 2 25 -3.4 -1.7 1.7 50% In Group 1 (n=24), kidney function stabilized after receiving rilparencel. The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference1 was statistically significant (p<0.001) and clinically meaningful. Of the 24 patients in Group 1, 15 (63%) met key Phase 3 PROACT 1 inclusion criteria, and similar efficacy results were observed in this subgroup compared to the full Group 1 results. As a reminder, the Phase 3 PROACT 1 protocol was amended in 1H 2024 after a similar eGFR efficacy signal was observed in the Phase 2 RMCL-002 study subgroup analysis (n=23) of high-UACR, Stage 4 CKD patients with type 2 diabetes. In Group 2 (n=25), the annual change in kidney function as measured by eGFR slope was -3.4 mL/min/1.73m2 in the pre-injection period versus -1.7 mL/min/1.73m2 in the period following the last rilparencel injection, resulting in an improvement of 50%, or 1.7 mL/min/1.73m2 per year. This difference was not statistically significant (p=0.085) but suggests evidence of a dose response. Out of the 25 patients in Group 2, 15 (60%) met the re-dosing trigger and received a second rilparencel injection. The median time between the first and second injections in these 15 patients was approximately 11 months. No rilparencel-related serious adverse events were observed across all patients in the study who received at least one rilparencel injection (n=49). The safety profile was consistent with previously reported study results and comparable to a kidney biopsy. Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology (ASN) 2025 Kidney Week as a late-breaking clinical trial. Phase 3 PROACT 1 Regulatory ProgressAs previously communicated, the FDA confirmed during a Type B meeting in Q4 2024 that the accelerated approval pathway is available for rilparencel if an acceptable surrogate endpoint, such as eGFR slope, is used. ProKidney has an upcoming FDA Type B meeting this summer to confirm the approach to using eGFR slope as the surrogate endpoint for accelerated approval. Additional details are expected in mid-2025. About Chronic Kidney DiseaseCKD is a progressive condition characterized by the gradual decline of kidney function, which can ultimately lead to end-stage kidney disease (ESKD) requiring dialysis or transplantation. An estimated 37 million adults in the U.S. have CKD, though many remain undiagnosed in the early stages. Diabetes is the leading cause of CKD, and individuals with both conditions face significantly elevated risks of cardiovascular events, hospitalization, and mortality. ProKidney is developing rilparencel for patients with Stage 3b/4 CKD and diabetes, a population that includes 1 to 2 million people in the U.S. While current treatment options aim to slow disease progression, there remains a substantial unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in patients with advanced CKD. About the Phase 3 REGEN-006 (PROACT 1) Clinical TrialREGEN-006 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel in subjects with advanced CKD and type 2 diabetes. The study protocol was amended in 1H 2024 to focus on a subset of patients with Stage 4 CKD (eGFR 20-30 mL/min/1.73m²) and late Stage 3b CKD (eGFR 30-35 mL/min/1.73m²) with accompanying albuminuria (UACR less than 5,000 mg/g for patients with eGFR 20-30 mL/min/1.73m² and 300-5,000 mg/g for patients with eGFR 30-35 mL/min/1.73m²). The total planned enrollment is approximately 685 subjects. Subjects are randomized (1:1) to the treatment group and the sham control group prior to kidney biopsy or a sham biopsy procedure, respectively. The primary objective is to assess the efficacy of up to two rilparencel injections (one in each kidney) using a minimally invasive percutaneous approach. The primary composite endpoint is the time from first injection to the earliest of: at least 40% reduction in eGFR; eGFR <15 mL/min/1.73m², and/or chronic dialysis, and/or renal transplant; or renal or cardiovascular death. About ProKidney a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney's lead product candidate, rilparencel (also known as REACT®), is a first-in-class, patented, proprietary autologous cellular therapy being evaluated for its potential to preserve kidney function in diabetic patients at high risk of kidney failure. Rilparencel has received RMAT designation from the FDA. For more information, please visit Forward-Looking StatementsThis press release includes 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. ProKidney's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as 'expect,' 'estimate,' 'project,' 'budget,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'may,' 'will,' 'could,' 'should,' 'believes,' 'predicts,' 'potential,' 'continue,' and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company's beliefs that the FDA agrees that the Company's Phase 3 REGEN-006 (PROACT 1) trial could be sufficient to support a potential BLA submission and full regulatory approval and that the Company could consider using eGFR slope as a surrogate endpoint on an accelerated approval pathway for rilparencel, expectations with respect to financial results and expected cash runway, including the Company's expectation that current cash will support operating plans into 2027, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company's products, if approved, potential regulatory approvals, the size and potential growth of current or future markets for the Company's products, if approved, the advancement of the Company's development programs into and through the clinic and the expected timing for reporting data, the making of regulatory filings or achieving other milestones related to the Company's product candidates, and the advancement and funding of the Company's developmental programs, generally. Most of these factors are outside of the Company's control and are difficult to predict. Factors that may cause such differences include, but are not limited to: disruptions to our business or that may otherwise materially harm our results of operations or financial condition as a result of our recent domestication to the United States; the inability to maintain the listing of the Company's Class A common stock on Nasdaq; the inability of the Company's Class A common stock to remain included in various indices and the potential negative impact on the trading price of the Class A common stock if excluded from such indices; the inability to implement business plans, forecasts, and other expectations or identify and realize additional opportunities, which may be affected by, among other things, competition and the ability of the Company to grow and manage growth profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the risk that results of the Company's clinical trials may not support approval; the risk that the FDA could require additional studies before approving the Company's drug candidates; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the Company's products, if approved, and its ability to serve those markets, either alone or in partnership with others; the Company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company's financial performance; the Company's intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the fact that interim results from our clinical programs may not be indicative of future results; the impact of geo-political conflict on the Company's business; and other risks and uncertainties included under the heading 'Risk Factors' in the Company's most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. The Company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. Investor Contacts: ProKidneyEthan Advisors, LLCDaniel Ferry Daniel@ 1 Difference in values is due to in to access your portfolio
CNN
29 minutes ago
- CNN
State inspection before floods found Camp Mystic had emergency plan in place
Two days before deadly Central Texas floods killed at least 27 people at Camp Mystic, a state inspector visited the youth camp and certified that it had an emergency plan in place and that its cabins and other buildings were safe, records obtained by CNN show. The inspector with the Texas Department of State Health Services confirmed on July 2 that the Christian camp on the banks of the Guadalupe River had a state-mandated plan 'for emergency shelter and for evacuation' in case of a disaster. In the wake of the devastation at the nearly 100-year-old summer camp, the state inspection report raises new questions about whether that emergency plan was adequate and how closely it was followed. The state health department does not maintain copies of youth camp emergency plans, but they are reviewed during each annual inspection, said Lara Anton, a spokesperson for the agency. Plans for disasters 'would include flooding,' she noted. Leaders at Camp Mystic did not respond to phone calls and an email from CNN about the disaster plan. 'Our hearts are broken alongside our families that are enduring this unimaginable tragedy,' a statement on the camp website read. 'We have been in communication with local and state authorities who are tirelessly deploying extensive resources to search for our missing girls.' Through a public records request, CNN obtained the most recent four years of annual inspections, which were first reported by KSAT. The inspections evaluated Camp Mystic on dozens of different safety and compliance rules on topics from water supply to bunk bed guardrails. Those also included state regulations requiring youth camps to formulate a written emergency plan 'in case of a disaster, serious accident, epidemic, or fatality,' and post it at a camp's office and 'in each permanent and semi-permanent occupied building.' Staff and volunteers must be made aware of the plan during trainings, and campers should be instructed about what to do in the event of a disaster or 'the need to evacuate.' The state inspector who visited Camp Mystic last week reported that it was complying with those requirements, confirming that a written emergency plan had been posted at the camp and staff and volunteers were made aware of it. The inspector also found that none of the camp's buildings or structures presented a safety hazard, all buildings complied with applicable building and safety codes, and all permanent structures were in 'good repair.' The camp passed the inspection with 'no deficiency/violation,' according to the records. The previous annual inspections over the last four years also found that Camp Mystic was following the rules on emergency planning. The camp had been hit with a few violations in recent years related to food preparation and insufficient documentation of experience or training for riflery and equine instructors, the records show. There were 386 campers and 64 staff members staying at the camp's Guadalupe River section, where the worst of the flooding happened, as well as 171 campers and 44 staff at the nearby Cypress Lake section of the camp, according to the July 2 inspection. When the floodwaters hit the camp in the early hours of July 4, counselors and staff helped young campers climb a hill to evacuate to higher ground, according to witness accounts. But waters rose so quickly that some campers and counselors, especially those in cabins on lower ground closest to the river, weren't able to make it out in time. Caroline Cutrona, a Camp Mystic counselor, told CNN that a power outage around 4 a.m. that morning meant that the camp's loudspeaker public address system wasn't working, and that she never received cell phone alerts about the flash flooding because counselors and campers weren't allowed to keep their phones with them. It's unclear whether the camp's emergency plan accounted for the communication breakdowns. Some of the cabins campers were staying in are located in the Guadalupe River's 'regulatory floodways' – the areas that flood first and are most dangerous – according to federal flood maps. Other cabins are located in an area that the federal government has determined has a 1% chance of flooding each year. But the Texas regulations for youth camps don't say anything about flood zones, and the state records don't show the annual inspections of Camp Mystic taking that into account.
