Coffee recalled from Dollar General over glass contamination concerns
The recall was issued Aug. 11 after a customer alerted Dollar General to the potential issue.
The coffee was sold and distributed in every state besides Hawaii and Alaska between July 9 to 21 of this year.
Customers are advised to dispose of the product and contact Dollar General for a full refund.
Dollar General is actively investigating the source of the glass. There have been no reported injuries so far.
Here is the full description of the recalled coffee according to the FDA:
8-Ounce Clover Valley Instant Coffee
Package UPC: 876941004069
Lot: L-5163 / Best By 12/13/2026
Lot: L-5164 / Best by 12/13/2026
Lot: L-5165 / Best by 12/14/2026
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Yahoo
an hour ago
- Yahoo
Celcuity Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Reported statistically significant and clinically meaningful improvement in both primary endpoints from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial Hazard ratios and improvements in median progression-free survival ('PFS') are unprecedented in HR+/HER2- advanced breast cancer ('ABC') Expect to submit a New Drug Application ('NDA') for gedatolisib, based on data from the PIK3CA wild-type cohort, to the U.S. Food and Drug Administration ('FDA') in the fourth quarter of 2025 Enrollment is ongoing in the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial and topline data readout is anticipated in the fourth quarter of 2025 First patient was dosed in Phase 3 VIKTORIA-2 clinical trial of gedatolisib as a first-line treatment for HR+/HER2- ABC Reported clinical data from two early phase studies of gedatolisib in patients with metastatic castration resistant prostate cancer ('mCRPC') and HER2+ metastatic breast cancer ('mBC') New patent for gedatolisib dosing regimen that extends patent exclusivity into 2042 was issued Completed concurrent offerings of convertible notes, common stock and pre-funded warrants, with net proceeds of $286.5 million; on a proforma basis, the net proceeds of these offerings along with our cash, cash equivalents, and short-term investments of $168.4 million as of June 30, 2025, results in $455 million of cash, cash equivalents, and short-term investments as of the end of Q2 2025 and is expected to fund operations through 2027 Management to host webcast and conference call today, August 14, 2025, at 4:30 p.m. ET MINNEAPOLIS, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the second quarter ended June 30, 2025 and other recent business developments. 'We have had an eventful past few months at Celcuity. Last month, we announced positive topline data from the PIK3CA wild-type cohort of the pivotal Phase 3 VIKTORIA-1 clinical trial, which showed unprecedented reduction in risk of disease progression or death and incremental improvement in progression free survival in patients with HR+/HER2- advanced breast cancer,' said Brian Sullivan, CEO and co-founder of Celcuity. 'We believe topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing. We are on track to submit the New Drug Application for gedatolisib, based on data from the PIK3CA wild-type cohort, later this year and to report topline data from the PIK3CA mutant cohort in the fourth quarter of 2025. Additionally, with our recent financing and our growing body of clinical data, we believe we are in a unique position to advance multiple potential blockbuster indications in breast and prostate cancer.' Second Quarter 2025 Business Highlights and Other Recent Developments In July 2025, the Company announced positive topline data for both primary endpoints of the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial that evaluated gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in patients with HR+/HER2- ABC whose disease had progressed on or after prior treatment with a CDK4/6 inhibitor. The efficacy results established several new milestones in the history of drug development for HR+/HER2- ABC. The gedatolisib triplet (gedatolisib, fulvestrant and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant based on a hazard ratio ('HR') of 0.24. The median PFS was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. The gedatolisib doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67% compared to fulvestrant based on a hazard ratio of 0.33. The median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months. Both gedatolisib regimens showed lower rates of hyperglycemia and stomatitis and the rate of discontinuation of all treatment due to a treatment-related adverse event ('AE'), was lower than was reported in a Phase 1b study in this patient population. Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year. Celcuity expects to submit an NDA to the FDA in the fourth quarter of 2025 for gedatolisib based on data from the PIK3CA wild-type cohort. Enrollment is ongoing in the PIK3CA mutant cohort of the VIKTORIA-1 trial and remains on track to report topline data by the end of 2025. In July 2025, the first patient was dosed in VIKTORIA-2, a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for patients with HR+/HER2- ABC who are endocrine therapy resistant. In July 2025, the US Patent and Trademark Office issued a new patent for gedatolisib covering the dosing regimen used in the VIKTORIA-1 clinical trial, extending the patent exclusivity in the U.S. into 2042. In July 2025, the Company conducted a concurrent public offering of 2.750% convertible senior notes due 2031, common stock and pre-funded warrants. The net proceeds from the offerings were $286.5 million, after deducting underwriting discounts and commissions and the Company's estimated offering expenses. In June 2025, the Phase 1b portion of the CELC-G-201 study reported positive topline data, and additional preliminary results will be presented at a medical conference later this year. As of the May 30, 2025 data cut-off, the preliminary efficacy and safety analyses for the combined arms showed the six-month radiographic progression free survival rate was 66%, no patients discontinued treatment due to a treatment-related AE, and no dose reductions were required with gedatolisib or darolutamide. In June 2025, the Company presented key efficacy and safety results from an investigator-sponsored Phase 2 clinical trial in 44 patients with HER2+/ PIK3CA mutated mBC, who were treated with gedatolisib plus standard doses of trastuzumab-pkrb, at the American Society of Clinical Oncologists meeting, which showed the objective response rate among all patients enrolled was 43%. Second Quarter 2025 Financial Results Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2025, compared to the second quarter ended June 30, 2024. Total operating expenses were $44.0 million for the second quarter of 2025, compared to $24.3 million for the second quarter of 2024. Research and development ('R&D') expenses were $40.2 million for the second quarter of 2025, compared to $22.5 million for the prior-year period. Of the approximately $17.7 million increase in R&D expenses, $6.6 million was related to increased employee and consulting expenses, $6.1 million was related to increased research and development costs primarily attributable to activities supporting our ongoing clinical trials, and $5.0 million is related to an anticipated development milestone payment under the license agreement with Pfizer. General and administrative ('G&A') expenses were $3.8 million for the second quarter of 2025, compared to $1.8 million for the prior-year period. Of the approximately $2.0 million increase in general and administrative expenses, $1.6 million was related to increased employee and consulting expenses. The remaining $0.4 million of the $2.0 million increase resulted from professional fees, expanding infrastructure and other administrative expenses. Net loss for the second quarter of 2025 was $45.3 million, or $1.04 loss per share, compared to a net loss of $23.7 million, or $0.62 loss per share, for the second quarter of 2024. Non-GAAP adjusted net loss for the second quarter of 2025 was $40.5 million, or $0.93 loss per share, compared to non-GAAP adjusted net loss of $22.2 million, or $0.58 loss per share, for the second quarter of 2024. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity's cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ('GAAP') to non-GAAP financial measures, please see the financial tables at the end of this press release. Net cash used in operating activities for the second quarter of 2025 was $36.2 million, compared to $18.1 million for the second quarter of 2024. At June 30, 2025, Celcuity reported cash, cash equivalents and short-term investments of $168.4 million. However, on a proforma basis, taking into account the net proceeds of the Celcuity's financing activities in the third quarter, cash, cash equivalents, and short-term investments as of the end of Q2 2025 was $455 million, which, we believe, when including drawdowns on our debt facility, will fund operations through 2027. Webcast and Conference Call Information The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the second quarter 2025 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: A replay of the webcast will be available on the Celcuity website following the live event. About Celcuity Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC has completed enrollment of and reported topline data for the PIK3CA wild-type cohort, and is currently enrolling patients for the PIK3CA mutant cohort. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC is currently enrolling patients. More detailed information about Celcuity's active clinical trials can be found at Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at Follow us on LinkedIn and X. Forward-Looking Statements This press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of topline clinical trial data; the market opportunity for gedatolisib; the ability of our data to support the filing of an NDA with the FDA; our expectations regarding the timing of and our ability to obtain and maintain FDA approval to commercialize gedatolisib; our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib ; our anticipated use of cash; and the strength of our balance sheet. Words such as, but not limited to, 'look forward to,' 'believe,' 'expect,' 'anticipate,' 'estimate,' 'intend,' "confidence," "encouraged," 'potential,' 'plan,' 'targets,' 'likely,' 'may,' 'will,' 'would,' 'should' and 'could,' and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our topline results are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our clinical trials; unforeseen delays in our planned NDA for gedatolisib; our ability to obtain and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; the development of therapies and tools competitive with gedatolisib; and our ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof. View source version of release on Contacts: Celcuity Inc. Brian Sullivan, bsullivan@ Vicky Hahne, vhahne@ (763) 392-0123 ICR HealthcarePatti Bank, 513-1284 Celcuity Inc. Condensed Balance Sheets (in thousands) June 30,2025 December 31,2024 (unaudited) Assets Current Assets: Cash and cash equivalents $ 46,354 $ 22,515 Investments 122,032 212,589 Other current assets 14,718 9,467 Total current assets 183,104 244,571 Property and equipment, net 357 336 Operating lease right-of-use assets 131 216 Total Assets $ 183,592 $ 245,123 Liabilities and Stockholders' Equity: Current Liabilities: Accounts payable $ 11,158 $ 9,366 Operating lease liabilities 139 172 Accrued expenses 28,644 22,185 Total current liabilities 39,941 31,723 Operating lease liabilities - 54 Note payable, non-current 99,276 97,727 Total Liabilities 139,217 129,504 Total Stockholders' Equity 44,375 115,619 Total Liabilities and Stockholders' Equity $ 183,592 $ 245,123 Celcuity Inc. Condensed Statements of Operations (unaudited) (in thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Operating expenses: Research and development $ 40,222 $ 22,498 $ 72,449 $ 43,145 General and administrative 3,787 1,786 7,693 3,632 Total operating expenses 44,009 24,284 80,142 46,777 Loss from operations (44,009 ) (24,284 ) (80,142 ) (46,777 ) Other (expense) income Interest expense (3,204 ) (2,260 ) (6,387 ) (3,661 ) Interest income 1,945 2,822 4,264 5,104 Other (expense) income, net (1,259 ) 562 (2,123 ) 1,443 Net loss before income taxes (45,268 ) (23,722 ) (82,265 ) (45,334 ) Income tax benefits - - - - Net loss $ (45,268 ) $ (23,722 ) $ (82,265 ) $ (45,334 ) Net loss per share, basic and diluted $ (1.04 ) $ (0.62 ) $ (1.90 ) $ (1.26 ) Weighted average common shares outstanding, basic and diluted 43,663,364 38,444,163 43,359,748 36,028,109 Cautionary Statement Regarding Non-GAAP Financial Measures This press release contains references to non-GAAP adjusted net loss and non-GAAP adjusted net loss per share. Management believes these non-GAAP financial measures are useful supplemental measures for planning, monitoring, and evaluating operational performance as they exclude stock-based compensation expense, non-cash interest expense, and non-cash interest income from net loss and net loss per share. Management excludes these items because they do not impact Celcuity's cash position, which management believes better enables Celcuity to focus on cash used in operations. However, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share are not recognized measures under GAAP and do not have a standardized meaning prescribed by GAAP. As a result, management's method of calculating non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may differ materially from the method used by other companies. Therefore, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may not be comparable to similarly titled measures presented by other companies. Investors are cautioned that non-GAAP adjusted net loss and non-GAAP adjusted net loss per share should not be construed as alternatives to net loss, net loss per share or other statements of operations data (which are determined in accordance with GAAP) as an indicator of Celcuity's performance or as a measure of liquidity and cash flows. Celcuity Inc. Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss and GAAP Net Loss Per Share to Non-GAAP Adjusted Net Loss Per Share (in thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP net loss $ (45,268 ) $ (23,722 ) $ (82,265 ) $ (45,334 ) Adjustments: Stock-based compensation Research and development (1) 1,722 978 3,227 1,810 General and administrative (2) 982 432 1,921 932 Non-cash interest expense (3) 789 630 1,589 1,160 Non-cash interest income (4) 1,286 (485 ) 340 (639 ) Non-GAAP adjusted net loss $ (40,489 ) $ (22,167 ) $ (75,188 ) $ (42,071 ) GAAP net loss per share - basic and diluted $ (1.04 ) $ (0.62 ) $ (1.90 ) $ (1.26 ) Adjustments to net loss: Stock -based compensation Research and development 0.04 0.02 0.08 0.05 General and administrative 0.02 0.01 0.04 0.03 Non-cash interest expense 0.02 0.02 0.04 0.03 Non-cash interest income 0.03 (0.01 ) 0.01 (0.02 ) Non-GAAP adjusted net loss per share $ (0.93 ) $ (0.58 ) $ (1.73 ) $ (1.17 ) Weighted average common shares outstanding, basic and diluted 43,663,364 38,444,163 43,359,748 36,028,109 (1) To reflect a non-cash charge to operating expense for Research and Development stock-based compensation. (2) To reflect a non-cash charge to operating expense for General and Administrative stock-based compensation. (3) To reflect a non-cash charge to other expense for amortization of debt issuance and discount costs and PIK interest related to the issuance of a note payable. (4) To reflect a non-cash adjustment to other income for accretion on investments. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
an hour ago
- Business Wire
RenovoRx Reports Commercial Revenue Growth in the Second Quarter 2025 and Announces Positive Independent Data Monitoring Committee Recommendation to Continue Pivotal Phase III TIGeR-PaC Trial Based on Interim Data Review
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- RenovoRx, Inc. ('RenovoRx' or the 'Company') (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, today announced its financial results and business update to shareholders for the second quarter ended June 30, 2025. 'We are pleased to report second quarter 2025 revenue of over $400,000. This growth highlights the strong clinical need and market demand for our patented RenovoCath device as a standalone targeted drug-delivery product among both new and existing customers. We are proud of the initial organic revenue growth over the first two full quarters since launching RenovoCath commercial sales, especially since this was achieved without a dedicated sales and marketing team. With the recent hiring of Phil Stocton as our Senior Director of Sales and Market Development, our goal is to stay lean, while also continuing to build commercialization momentum. We will continue to gather important data about our market (such as such as sales cycles, activation times, individual customer preferences and other commercial matters), as we seek to grow our customer base, fulfill repeat RenovoCath orders, and position ourselves for commercial growth over the long term,' said Shaun Bagai, CEO of RenovoRx. 'At the same time, we are very excited to report that the independent Data Monitoring Committee (DMC) for our ongoing Phase III TIGeR-PaC trial recently completed their review of our second pre-planned interim analysis and has recommended that we continue the study. This is great news, as we believe the DMC's recommendation is an expression of confidence in the potential for a positive outcome in the trial overall,' continued Mr. Bagai. 'With a view towards preserving the integrity of the TIGeR-PaC trial for FDA purposes, and following our review of general FDA guidance, discussions with the DMC, and consultation with regulatory advisors, we are deferring publishing our second interim data. Outside of our Chief Medical Officer, Dr. Ramtin Agah, who has been speaking directly with the DMC, our entire team will remain blinded to the interim data. We will revisit publishing the actual second interim data, most likely upon completion of the study as is common for pivotal Phase III trials. As of August 12, 2025, 95 patients have been randomized and 61 events have occurred, putting us on target to complete enrollment this year or early next year,' concluded Mr. Bagai. RenovoCath Commercialization Update RenovoRx continued its RenovoCath commercialization progress, with thirteen cancer center customers approved to purchase the device, including several high-volume, National Cancer Institute (NCI)-designated academic and community centers, an increase from five centers in the first quarter of 2025. Four of these thirteen cancer centers have used the device in patients, and all have made repeat purchase orders subsequently. RenovoRx believes that many of the 18 cancer centers that have used RenovoCath as part of its ongoing, pivotal Phase III TIGeR-PaC trial could also be potential customers for RenovoCath after the completion of TIGeR-PaC enrollment, which is expected later this year or early next year. All of this is being accomplished in-house by RenovoRx without a dedicated sales and marketing team. RenovoRx plans to strategically add a small number of sales personnel in the second half of 2025 as it looks to widen market penetration in 2026. RenovoRx believes that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an estimated initial $400 million peak annual U.S. sales opportunity. Beyond historical RenovoCath usage, RenovoRx commercial efforts are already indicating the adoption of RenovoCath technology for the treatment of other solid tumors. This serves as the basis for our belief in the potential for a several-billion-dollar TAM as we expand into additional applications. Ongoing Pivotal Phase III TIGeR-PaC Trial Update In the TIGeR-PaC trial, RenovoRx is evaluating its first investigational drug-device combination oncology product candidate which uses the proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform enabled by RenovoCath for the treatment of locally advanced pancreatic cancer (LAPC). RenovoRx's combination product candidate utilizes RenovoCath for the intra-arterial administration of the chemotherapy gemcitabine (or IAG). The current protocol and statistical analysis plan for the Phase III TIGeR-PaC trial requires 114 randomized patients, with 86 events, or deaths, necessary to complete the final analysis. In the second quarter of 2025, the 52 nd death triggered the second pre-planned interim analysis to be reviewed by the independent Data Monitoring Committee. The DMC has concluded its review and has recommended that the Company continue with the trial. To avoid compromising the integrity of the trial with the FDA, and after discussions with the DMC and consultation with its regulatory advisors, RenovoRx elected to defer publishing the interim data. RenovoRx will revisit publishing the actual second interim data, most likely upon completion of the study as is common for pivotal Phase III trials. Second Quarter 2025 and Subsequent Key Highlights During the second quarter of 2025, RenovoRx increased production of the RenovoCath device to meet increased demand for the targeted delivery of diagnostic and/or therapeutic agents from oncologists and interventional radiologists. The principal manufacturer of RenovoCath devices is Medical Murray Inc., based in the U.S. in North Barrington, IL. RenovoRx highlighted strong progress in its commercialization efforts. Since launching its commercial efforts in December 2024, RenovoRx has established commercial momentum for RenovoCath, with thirteen cancer center customers approved to purchase the device, including several high-volume, National Cancer Institute (NCI)-designated academic and community centers, an increase from five centers in the first quarter of 2025. Four of these thirteen cancer centers have used the device in patients, and all have made repeat purchase orders subsequently. This momentum highlights the growing clinical demand across the United States for novel, localized solid tumor drug-delivery options beyond methods like systemic intravenous delivery of chemotherapy. RenovoRx believes that many of the 18 cancer centers that have used RenovoCath as part of its ongoing, pivotal Phase III TIGeR-PaC trial could also be potential customers for RenovoCath after the completion of TIGeR-PaC enrollment, which is expected later this year or early next year. To coordinate, execute, and expand its commercial efforts for RenovoCath, subsequent to the quarter, RenovoRx hired Philip Stocton as Senior Director of Sales and Market Development. Mr. Stocton brings over 25 years of experience in MedTech sales, marketing, and leadership from various commercial positions at Terumo, Johnson & Johnson, Varian (acquired by Siemens), and, most recently, Sirtex Medical. Over the past 10 years, he has specialized in interventional oncology in both domestic and international roles. Prior to his hiring, Mr. Stocton had been consulting for RenovoRx in connection with its RenovoCath commercial launch planning efforts. During the quarter, RenovoRx initiated patient enrollment with Johns Hopkins Medicine for the Phase III TIGeR-PaC clinical trial, becoming the newest addition to a distinguished network of clinical cancer sites across the United States participating in the trial. RenovoRx also received an Issue Notification from the U.S. Patent and Trademark Office (USPTO) indicating that U.S. patent No. 12,290,564 became effective on May 6. This patent, titled 'Methods for Treating Tumors,' expands protection of methods for drug delivery with RenovoRx's TAMP therapy platform, enabled by RenovoCath. The patent covers new methods for treating a tumor by delivering drugs locally to a region of an artery or blood vessel that is near the tumor after treating this region to reduce the microvasculature. The new patent provides protection through November of 2037. Subsequent to the quarter, RenovoRx launched a multi-center post-marketing registry study to follow patients undergoing cancer treatment delivered by its RenovoCath device to solid tumors. The PanTheR study is an important initiative aimed at evaluating the safety and effectiveness of RenovoCath in real-world clinical settings. This multi-center, post-marketing observational registry study is designed to assess long-term safety and survival outcomes in patients with solid tumors who receive targeted drug delivery via RenovoCath. By collecting real-world data on the use of RenovoCath across a broader range of tumor types, PanTheR aims to provide valuable insights into patient outcomes and support the generation of additional safety data. Financial Highlights for the Second Quarter Ended June 30, 2025 Revenue: RenovoRx reported second quarter revenues of approximately $422,000 from commercial sales of the RenovoCath device, driven by new customer purchase orders and early repeat orders from our initial sites. June 30, 2025 marked our second full quarter of revenue generation from RenovoCath sales. Cash Position: As of June 30, 2025, the Company had $12.3 million in cash and cash equivalents. The Company's plan is for revenues from RenovoCath sales to reduce its burn rate over time. The Company believes that cash as of June 30, 2025 will fully fund both ongoing RenovoCath scale-up efforts and additional progress towards the completion in the Phase III TIGeR-PaC trial. R&D Expenses: Research and development expenses were $1.4 million, for the quarter ended June 30, 2025, compared to $1.5 million for the quarter ended June 30, 2024. The $0.1 million decrease was primarily driven by a decrease in other clinical and regulatory expenses including an allocation of selling, general and administrative expenses to research and development of $0.2 million. This decrease was offset by an increase in non-recurring engineering costs to scale manufacturing and the development of our next generation RenovoCath delivery system by $0.1 million to support and expand our commercial program. SG&A Expenses: Selling, general, and administrative expenses were approximately $1.5 million, for the quarter ended June 30, 2025, remaining relatively unchanged from the same period in the prior year. Net Loss: Net loss was $2.9 million for the quarter ended June 30, 2025, compared to a net loss of $2.4 million for the quarter ended June 30, 2024. The $0.5 million increase was primarily due to the change in the fair value of the warrant liability of $0.9 million offset by a decrease in loss from operations of $0.4 million. Shares Outstanding: As of August 11, 2025, shares of common stock outstanding totaled 36,645,884. Conference Call Details For interested individuals unable to join the conference call, a dial-in replay of the call will be available until September 14, 2025, and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number: 13754672. A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx's Investor Relations website after the event. RenovoRx, Inc. Selected Statement of Operations Data (Unaudited) (in thousands, except for share and per share amount) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Revenues $ 422 $ - $ 619 $ - Cost of revenues 152 - 246 - Gross profit $ 270 $ - $ 373 $ - Operating expenses: Research and development 1,426 1,542 3,068 2,799 Selling, general and administrative 1,522 1,492 3,093 2,711 Total Operating expenses 2,948 3,034 6,161 5,510 Loss from operations (2,678 ) (3,034 ) (5,788 ) (5,510 ) Change in fair value of warrant liability (350 ) 507 234 1,870 Interest and dividend income 133 138 239 175 Total other (expense) income, net (217 ) 645 473 2,045 Net loss $ (2,895 ) $ (2,389 ) $ (5,315 ) $ (3,465 ) Net loss per share, basic and diluted $ (0.08 ) $ (0.10 ) $ (0.16 ) $ (0.18 ) Weighted-average shares of common stock outstanding, basic and diluted 36,576,567 34,000,539 19,498,306 Expand About RenovoCath Based on its FDA clearance, RenovoCath ® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ('IFU'), please see: About RenovoRx, Inc. RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath ®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx's patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy's toxicities versus systemic intravenous therapy. RenovoRx's novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents. In addition to the RenovoCath device, RenovoRx is also evaluating its novel drug-device combination oncology product candidate (intra-arterial gemcitabine via RenovoCath, known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA's 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company's patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA. RenovoRx is also actively commercializing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, several of these customers have already initiated repeat orders in parallel to RenovoRx expanding the number of medical institutions initiating new RenovoCath orders, including several esteemed, high-volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity, either on its own or in tandem with a medical device commercial partner. For more information, visit Follow RenovoRx on Facebook, LinkedIn, and X. Cautionary Note Regarding Forward-Looking Statements This press release and statements of the Company's management made in connection therewith contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our pre-clinical and clinical trials and studies, including the overall timing and timing for additional interim data readouts and timing for full enrollment for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential of RenovoCath ® or TAMP™ as standalone commercial products, our anticipated timing and levels of for revenue generation from RenovoCath sales, and our commercialization plans in general, (iii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iv) our efforts to explore commercialization strategies utilizing our TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, commercial plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to significant known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as 'may,' 'expects,' 'plans,' 'aims,' 'anticipates,' 'believes,' 'forecasts,' 'estimates,' 'intends,' and 'potential,' or the negative of these terms or other comparable terminology regarding RenovoRx's expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our execution of our commercial strategy for RenovoCath or our TAMP technology may not lead to viable or repeating revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of the Phase III TIGeR-PaC trial and any other preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled 'Risk Factors' in documents that we file from time to time with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.
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Tivic Reports Second Quarter 2025 Financial Results
FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (NASDAQ: TIVC), a diversified immunotherapeutics company, today announced financial results for the second quarter and six months ended June 30, 2025. 'We have established a strong foundation for Tivic's strategic transformation with our expansion into biopharmaceuticals, making us unique in treating disease by addressing both the body's biochemical and bioelectronic systems,' stated Tivic CEO Jennifer Ernst. 'To maximize our focus on the compelling, late-stage clinical pipeline, we have increasingly shifted resources away from consumer healthtech and are now planning to exit the ClearUP business by the end of this year,' continued Ernst. 'I look forward to advancing the commercialization of these life-saving therapies, supporting our strategy to increase shareholder value through this transformation.' Corporate Highlights from the Second Quarter and Subsequent Weeks, included: Securing positive interest in potential military and defense applications for drug candidate Entolimod™ to treat ARS during briefings with the White House and U.S. Food & Drug Administration (FDA) officials. Extending the worldwide license of Entolimod™ to include the treatment of neutropenia, a condition that reduces the body's ability to combat infections and has a wide range of causes - from genetics to cancer treatments and age. Entering into a GMP manufacturing validation agreement with Scorpius Biomanufacturing, Inc. as part of preparing for the FDA biologics license application process. Completing all study visits in the Optimization Study for its patent-pending, non-invasive cervical vagus nerve stimulation (ncVNS) device. Raising $1.4 million from the first and second tranche of a preferred equity purchase agreement that provides for up to $8.4 million in total financing. Entering into a $25 million equity line of credit that generated net proceeds of $547,000. Receiving shareholder approval of key measures in support of Tivic transformation strategy. Expanding biopharmaceutical team with regulatory, clinical and business development staff. Naming Lisa Wolf as CFO following her nine-month tenure as interim CFO. Financial Performance: Revenue (net of returns) for the three and six months ended June 30, 2025 totaled $86,000 and $156,000, respectively, compared with $140,000 and $474,000 for 2024. The decreases are due to lower unit sales of ClearUP™ to treat sinus pain and pressure. The lower sales are attributable to decreases in advertising expenses as the company focused resources on accelerating its TLR5 program for the development of Entolimod™ for ARS. Gross profit in the three and six months ended June 30, 2025 was $54,000 and $104,000, respectively, compared to $30,000 and $197,000 in 2024. Gross margin was 67% in the six months ended June 30, 2025, compared to 42% in 2024. Operating expenses in the three and six months ended June 30, 2025 was $2.0 million and $3.5 million, respectively, compared to $1.3 million and $3.0 million in 2024. The increases were primarily due to the addition of the biopharma programs in February 2025. Net loss of $1.9 million for the three months ended June 30, 2025, compared to $1.3 million in the second quarter of 2024. Net loss of $3.4 million for the first half of 2025, compared to $2.7 million for the first half of 2024. At June 30, 2025, cash and cash equivalents totaled $1.2 million, compared with $2.0 million, at December 31, 2024. Subsequent to quarter's end, the Company raised a total of $0.9 million through utilization of its equity line of credit and the sale of Series B Preferred Stock pursuant to its preferred equity purchase agreement. The company has no debt on its balance sheet. Approximately $7.0 million remains available as a committed investment in Tivic through a preferred equity purchase agreement. The company believes the current and committed funding is sufficient to make meaningful progress toward manufacturing validation for Entolimod. Conference Call and Webcast Information Management will host a webcast/conference call today, Thursday, August 14, at 1:30 p.m. PT / 4:30 p.m. ET to discuss the company's second quarter 2025 financial results and provide a business update. Webcast Link An audio replay of the call will be available for the next 90 days from the investor page on the Tivic Health website at About Tivic Tivic's dual platform utilizes the body's biopharmaceutical and bioelectronic systems to treat unmet medical needs through targeting the immune system. Tivic's biologics compounds activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The company's lead drug candidate, Entolimod™ for acute radiation syndrome, is a novel TLR5 agonist that has been granted Fast Track designation and is in late stage development. Tivic's bioelectronic program is developing a novel, non-invasive medical device designed to target the neural pathways implicated in many prevalent and debilitating diseases. Early trials show promising signals that Tivic's approach may regulate specific biologic responses, and the company believes its early-stage vagus nerve stimulation device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted devices. To learn more about Tivic, visit: Forward-Looking Statements This press release may contain '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 are based on Tivic Health Systems, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of interactions with and guidance from the FDA and other regulatory authorities; changes to the company's relationship with the its partners; the failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company's business strategy; timing and success of clinical trials and study results; regulatory requirements and pathways for approval; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading 'Risk Factors," as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law. Tivic Health Systems, Inc. Condensed Statements of Operations (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 REVENUES $ 86 $ 140 $ 156 $ 474 COST OF SALES 32 110 52 277 GROSS PROFIT 54 30 104 197 OPERATING EXPENSES Research and development 655 302 990 558 Sales and marketing 426 207 605 712 General and administrative 907 787 1,949 1,674 TOTAL OPERATING EXPENSES 1,988 1,296 3,544 2,944 NET OPERATING LOSS (1,934 ) (1,266 ) (3,440 ) (2,747 ) OTHER INCOME, NET 3 0 7 0 NET LOSS $ (1,931 ) $ (1,266 ) $ (3,433 ) $ (2,747 ) NET LOSS PER SHARE - BASIC AND DILUTED $ (2.19 ) $ (5.37 ) $ (4.64 ) $ (17.05 ) WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED 881,294 235,868 739,618 161,103 Expand
