Latest news with #clinicalpipeline
Yahoo
3 days ago
- Business
- Yahoo
Dare Bioscience Inc (DARE) Q2 2025 Earnings Call Highlights: Strategic Advances and Financial ...
Release Date: August 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Dare Bioscience Inc (NASDAQ:DARE) is on track to launch its sildenafil cream, Dare to Play, through a 503b outsourcing facility in Q4 2025, marking a significant milestone in women's sexual health. The company is advancing a differentiated clinical pipeline with grant-funded programs targeting unmet needs in contraception, HPV, and preterm birth. Dare Bioscience Inc (NASDAQ:DARE) received positive feedback from its direct-to-patient awareness campaign, highlighting significant interest in its products. The Oviprine Phase 3 trial continues as planned with no new safety concerns, supporting its potential as a hormone-free contraceptive option. The company strengthened its financial position with $17.6 million in net proceeds from stock sales and a $6 million grant payment, enhancing its ability to execute its strategy. Negative Points Dare Bioscience Inc (NASDAQ:DARE) ended the quarter with a working capital deficit of approximately $12.6 million. The company experienced a 71% decrease in R&D expenses compared to Q2 2024, primarily due to reductions in manufacturing and development costs. There were technical difficulties during the earnings call, preventing a Q&A session, which may have limited investor engagement. The company's dual path strategy involves risks associated with FDA approval processes and market acceptance of its products. Despite the progress, the company operates in a highly competitive market with significant challenges in bringing new women's health solutions to market. Q & A Highlights Warning! GuruFocus has detected 3 Warning Signs with DARE. Q: What is the status of the Dare to Play Sildenafil Cream launch? A: Sabrina Martucci Johnson, President and CEO, stated that Dare Bioscience remains on track to support the commercial availability of Dare to Play Sildenafil Cream through a 503b outsourcing facility in the fourth quarter of 2025. This launch is a significant milestone for the company and the field of women's sexual health. Q: Can you provide an update on the Ovaprine Phase 3 trial? A: Sabrina Martucci Johnson explained that the Independent Data and Safety Monitoring Board reviewed interim data from the Phase 3 study and recommended that the trial continue as planned. The interim pregnancy rate was consistent with expectations, supporting Ovaprine's potential as a non-hormonal contraceptive option. Q: What is the dual commercialization pathway for DARE HRT1? A: Sabrina Martucci Johnson highlighted that DARE HRT1, an intravaginal ring for hormone therapy, is pursuing both FDA approval and a 503b compounding opportunity. This approach aims to accelerate patient access while generating necessary data for FDA approval. Q: How is Dare Bioscience expanding into consumer health products? A: Sabrina Martucci Johnson announced plans to launch two non-prescription vaginal probiotics to support vaginal microbiome health. These products will complement the prescription offerings and diversify the company's commercial platform. Q: What are the financial highlights for the second quarter of 2025? A: Marty Herringlayton, Chief Accounting Officer, reported that Dare Bioscience ended the quarter with approximately $5 million in cash and a working capital deficit of $12.6 million. Post-quarter, the company received $17.6 million from stock sales and a $6 million grant, strengthening its balance sheet. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. 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
Globe and Mail
3 days ago
- Business
- Globe and Mail
Tivic Reports Second Quarter 2025 Financial Results
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. Teleconference Details: Toll Free: 877-545-0523 International: 973-528-0016 Participant Access Code: 793820 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. June 30, 2025 December 31, 2024 (Unaudited) (Audited) ASSETS Cash and cash equivalents $ 1,184 $ 2,002 Other current assets 658 637 TOTAL CURRENT ASSETS 1,842 2,639 PROPERTY AND EQUIPMENT, NET 120 119 NONCURRENT ASSETS 2,546 49 TOTAL ASSETS $ 4,508 $ 2,807 LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable and accrued expenses $ 821 $ 272 TOTAL CURRENT LIABILITIES 821 272 TOTAL LONG-TERM LIABILITIES — — STOCKHOLDERS' EQUITY Preferred stock — — Common stock 1 1 Additional paid in capital 50,661 46,075 Accumulated deficit (46,975 ) (43,541 ) TOTAL STOCKHOLDERS' EQUITY 3,687 2,535 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 4,508 $ 2,807 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
