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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
Yahoo
18-07-2025
- Business
- Yahoo
HOOKIPA Pharma Announces Intention to Voluntarily Delist and Deregister its Common Stock
NEW YORK and VIENNA, July 18, 2025 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, 'HOOKIPA'), a clinical-stage biopharmaceutical company developing next-generation immunotherapeutics for the treatment of cancer and serious infectious diseases, today announced its intention to voluntarily delist from the Nasdaq Capital Market ('Nasdaq') and to deregister its common stock under Section 12(b) and Section 12(g) of the Securities Exchange Act of 1934, as amended (the 'Exchange Act'), and suspend its reporting obligations under Section 15(d) of the Exchange Act. In connection with the consideration and evaluation of HOOKIPA's long-term prospects and strategies by HOOKIPA's board of directors, on May 21, 2025 HOOKIPA entered into an asset purchase agreement ('Asset Purchase Agreement') with Gilead Sciences, Inc. ('Gilead') pursuant to which Gilead will acquire all of HOOKIPA's assets primarily related to or necessary for the conduct of HOOKIPA's HB-400 program, currently in clinical development for the treatment of hepatitis B virus, and certain of HOOKIPA's assets related to HOOKIPA's HB-500 program, currently in clinical development for the treatment of human immunodeficiency virus (collectively, the 'Asset Sale'). HOOKIPA has been developing the HB-400 and HB-500 programs in collaboration with Gilead pursuant to the collaboration and license agreement with Gilead. HOOKIPA is holding a special meeting of stockholders (the 'Special Meeting') on July 29, 2025, at 10:00 a.m. Eastern Time to seek stockholder approval of the Asset Sale and to approve the dissolution and liquidation of HOOKIPA in accordance with Delaware law. If the stockholders approve the Asset Sale and the dissolution and liquidation of HOOKIPA, HOOKIPA intends to file a Certificate of Dissolution (the 'Certificate of Dissolution') with the Delaware Secretary of State as soon as practicable following the closing of the Asset Sale and the completion of the transfer plan under the Asset Purchase Agreement. Upon HOOKIPA's filing of a Certificate of Dissolution with the Delaware Secretary of State, the winding up and liquidation of HOOKIPA will commence. In determining to voluntarily delist and deregister its common stock, HOOKIPA considered that, assuming its stockholders approve the Asset Sale and the dissolution and liquidation of HOOKIPA at the Special Meeting, following the Asset Sale and through the subsequent liquidation and dissolution of the company, HOOKIPA would have an obligation to continue to comply with the applicable reporting requirements of the Securities Exchange Act of 1934, as amended, even though compliance with these reporting requirements would be economically burdensome in light of the Asset Sale and HOOKIPA's announced intent to dissolve and liquidate. Further, the expenses incurred by HOOKIPA in complying with the applicable reporting requirements would reduce the assets available for ultimate distribution to stockholders. On July 18, 2025, HOOKIPA notified Nasdaq of its intent to voluntarily delist its common stock from Nasdaq. HOOKIPA currently anticipates that it will file with the Securities and Exchange Commission ('SEC') a Form 25 relating to the delisting and deregistration of its common stock on or about July 29, 2025, and anticipates that the delisting and deregistration under Section 12(b) of its common stock will then become effective on or about August 8, 2025. Following the delisting, any trading in HOOKIPA's common stock would only occur in privately negotiated sales and potentially on an over-the-counter market; however, there is no guarantee that a broker will make a market in the common stock and that trading of the common stock will continue on an over-the-counter market or otherwise. Following the delisting of its common stock from Nasdaq, HOOKIPA intends to file a Form 15 with the SEC to deregister its common stock under Section 12(g) of the Exchange Act and suspend its reporting obligations under Section 15(d) of the Exchange Act. As a result of the filing of the Form 15, HOOKIPA's obligation to file certain Exchange Act reports and forms with the SEC, including certain Forms 10-K, 10-Q and 8-K, will cease. HOOKIPA will generally be relieved of all reporting obligations under the Exchange Act upon the effectiveness of the Form 15. The Company expects that the deregistration of its common stock will become effective 90 days after the filing of the Form 15 with the SEC. About HOOKIPAHOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing next generation immunotherapeutics based on its proprietary arenavirus platform. The company's product candidates are designed to induce specific, robust and durable CD8+ T cells and antibodies to eliminate cancers and serious infectious diseases. HOOKIPA's pipeline includes biological therapies for oncology, targeting human papillomavirus type 16-positive (HPV16+) cancers, KRAS mutated cancers, and other targets. In addition, HOOKIPA has partnered with Gilead Sciences, Inc. to develop therapies that are intended to provide functional cures for hepatitis B virus (HBV) and human immunodeficiency virus-1 (HIV-1). Find out more about HOOKIPA online at Forward Looking StatementsCertain statements set forth in this press release constitute 'forward-looking' statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as 'anticipates,' 'believes,' 'expects,' 'plans,' 'potential,' 'will,' 'would' or similar expressions and the negative of those terms. Forward-looking statements in this press release include HOOKIPA's statements regarding its plans and its ability to successfully delist from Nasdaq and to deregister its common stock as well as the anticipated benefits thereof, the potential for a trading market in HOOKIPA's common stock following the delisting, and HOOKIPA's expectations to close the Asset Sale and to dissolve and liquidate. Such forward-looking statements involve substantial risks and uncertainties that could cause actual results or events to differ materially from those that may be expressed or implied by these forward-looking statements, including, but not limited to, the uncertainty of stockholder approval of the Asset Sale and the dissolution and liquidation of HOOKIPA, the timing and ability of HOOKIPA to close the Asset Sale, the timing and effectiveness of HOOKIPA's delisting and deregistration of the common stock, and the sufficiency of existing cash to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of HOOKIPA in general, see HOOKIPA's Annual Report on Form 10-K for the year ended December 31, 2024, as well as discussions of potential risks, uncertainties, and other important factors in HOOKIPA's subsequent filings with the SEC, which are available on the SEC's website at and HOOKIPA's website at All information in this press release is as of the date of the release, and HOOKIPA undertakes no duty to update this information unless required by law. Availability of Other Information About HOOKIPAInvestors and others should note that we announce material financial information to our investors using our investor relations website, SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media, to communicate with our investors and the public about our company, and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the social media channels listed on our investor relations website. For further information, please contact: InvestorsChuck PadalaChuck@ 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
Yahoo
10-07-2025
- Business
- Yahoo
Epitopea Expands its Clinical Development and Research Capabilities as it Accelerates to the Clinic
CAMBRIDGE, United Kingdom and MONTREAL, July 10, 2025 (GLOBE NEWSWIRE) -- Epitopea, a transatlantic cancer immunotherapeutics company developing accessible, off-the-shelf RNA-based immunotherapies, today announced the formation of its dedicated clinical team and the expansion of its research team. These developments represent a significant milestone in the company's ongoing progress in advancing its RNA-based immunotherapies, known as CryptiVax™, into clinical trials. Siri Brinchmann-Hansen Torhaug, Head of Oncology Development, and Gertrud Koefoed Rasmussen, Head of Development Operations, will both join Epitopea's Executive leadership team. They report into Dr. Klaus Edvardsen, who has served as Epitopea's Chief Medical Officer (CMO) since February 2025 and oversees the strategic direction of clinical trials and regulatory affairs. Epitopea's research team in Cambridge has been extended to include translational immunology capabilities with the appointment of Dr. Theres Oakes as Director of Translational Sciences and Dr. Lisa Smith as Director of Research (UK). Both report into Dr. Jon Moore, Co-founder and Chief Scientific Officer (CSO) of Epitopea, and will work in close collaboration with the clinical team to ensure the seamless integration of research and clinical strategies. Siri Brinchmann-Hansen Torhaug is a highly accomplished, board-certified, oncology specialist with extensive experience in clinical strategy and development. Siri has worked in various senior leadership roles, including as Chief Medical Officer at Nykode Therapeutics, where she was instrumental in developing clinical strategies for oncology and autoimmune disease therapies. She brings a wealth of experience from working across both early-phase translational research and late-stage clinical trials. At Epitopea, Siri will focus on clinical strategy and development, ensuring that the company's pipeline moves forward with precision and efficacy. 'It's a pleasure to join Epitopea's Executive and clinical leadership team,' said Siri Brinchmann-Hansen Torhaug, Head of Oncology Development. 'With my background in oncology clinical trials, I am excited to contribute to the company's innovative work in cancer immunotherapy. I look forward to working alongside Klaus and Gertrud to advance Epitopea's promising pipeline, with the aim of improving patient outcomes in oncology.' Gertrud Koefoed Rasmussen brings over 20 years of experience in clinical operations across multiple therapeutic areas, including oncology and rare diseases. Most recently, Gertrud held the position of VP and Head of Development Operations at Nykode Therapeutics, where she built and expanded the clinical operations department and led clinical trials across all phases of development. She has extensive experience in vendor management, regulatory compliance, and process optimization. At Epitopea, Gertrud will lead clinical trial management and regulatory compliance, ensuring that trials are conducted efficiently and in accordance with regulatory guidelines. 'Joining Epitopea is an exciting opportunity to leverage my expertise in clinical operations and contribute to the development of innovative therapies,' said Gertrud Koefoed Rasmussen, Head of Development Operations. 'I look forward to collaborating with the team to manage and execute clinical trials that will bring groundbreaking cancer immunotherapies to patients with significant unmet medical needs.' Dr. Klaus Edvardsen, CMO of Epitopea, commented, 'It is an honor to lead the formation of this clinical team, and I am thrilled to work with Gertrud and Siri, who both bring invaluable experience and expertise to Epitopea. Their leadership will be crucial as we move forward with our clinical trials and work to bring our transformative cancer immunotherapies to the clinic.' As part of the research team appointments, Dr. Theres Oakes brings extensive expertise in antigen-directed immuno-oncology through her academic training and prior role at Achilles Therapeutics. Dr. Lisa Smith brings considerable experience in drug discovery and oncology from her previous roles at Kudos Therapeutics, Mission Therapeutics and Benevolent AI. Dr. Jon Moore, CSO and Co-Founder of Epitopea, commented, 'We are harnessing the talents of our existing research team and recent joiners to build world-class cancer immunotherapeutics. To this end, we welcome Lisa to accelerate these efforts. Furthermore, with the translational sciences team we are building around Theres, we will have the capability to assess the performance of our immunotherapeutics in patients with unrivalled precision. It has been a real privilege to be able to build such a strong biology group, and I am very excited to see what impact we can make on the treatment of these devastating diseases.' About EpitopeaEpitopea is a transatlantic cancer immunotherapeutics company developing accessible off-the-shelf RNA-based immunotherapies for use in hard-to-treat cancers by targeting a new class of untapped tumor-specific antigens, which are known as Cryptigen™ TSAs, that are broadly shared across multiple patients with the same tumor type. The company has created an extensive library of novel Cryptigen™ TSAs, discovered by its proprietary CryptoMap™ platform that leverages immunopeptidomics, genomics, and a bioinformatics pipeline, allowing the identification of aberrantly-expressed, tumor-specific antigens (aeTSAs) that are hidden within cancer's 'junk' DNA. These hidden Cryptigen™ TSAs were first discovered through research led by Drs. Claude Perreault and Pierre Thibault at the Institute for Research in Immunology and Cancer at the Université de Montréal. Epitopea is backed by leading life science investors including Advent Life Sciences, CTI Life Sciences, Cambridge Innovation Capital, Le Fonds de Solidarité FTQ, Investissement Québec, adMare BioInnovations, Jonathan Milner, the Harrington Discovery Institute, IRICoR and Novateur Ventures. The company has a license and research collaboration with MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA). Epitopea was founded in 2021 and consists of sister companies based in Cambridge, UK and in Montreal, Canada. For additional information, please visit and follow us on LinkedIn. For further information EpitopeaDr. Alan C. Rigby – Scius Communications (for Epitopea)Katja Stout+44 7789 435990katja@ Daniel Gooch+44 7747 875479daniel@ 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
