Fertility Startup Gameto Raises $44 Million to Test Egg-Freezing Therapy in US
The funding round, led by Overwater Ventures, will let Gameto bring its Fertilo therapy closer to US Food and Drug Administration approval. The technique, which uses stem cells that have been engineered into ovarian support cells, is intended to free patients from the grueling two weeks of injections that prompt ovaries to make enough eggs during fertility treatment. In a Phase 3 trial, patients are only given three days of injections, after which their eggs are extracted and matured by the engineered cells.
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Boston Globe
a minute ago
- Boston Globe
Why young children may not get COVID shots this fall
In July, the FDA granted full approval to Moderna's COVID vaccine for children — but only for those who have health conditions that may put them at increased risk should they become infected. Novavax's COVID vaccine has never been available for children younger than 12. The upshot is that if the FDA does not renew Pfizer's authorization for children 6 months to 4 years, or fully approve the vaccine, healthy children in that age group will have no officially sanctioned options — although doctors may still choose to provide the vaccine 'off label.' Advertisement That the FDA might rescind the authorization was first reported by The Guardian. 'Unfortunately, this leaves one of the vulnerable groups, specifically healthy children less than 2 years old, without access to a safe vaccine that's known to prevent hospitalization and death,' said Dr. Lakshmi Panagiotakopoulos, who oversaw the CDC's work group on the COVID vaccine before she resigned in June. Advertisement The risk of severe illness and hospitalization among children younger than 1 who are infected with the coronavirus is comparable to that among adults 65 and older. That's why experts have said that a child's first exposure should be through a vaccine, rather than infection. A late-summer COVID wave is moving across the nation, even as children are preparing to return to school. Fortunately, hospitalization rates remain low. In May, Health Security Robert F. Kennedy Jr. announced that COVID vaccines would no longer be offered to healthy children or pregnant women. Kennedy has called the Pfizer and Moderna vaccines dangerous. In May 2021, in the thick of the pandemic, he filed a petition with the FDA demanding that the agency revoke authorization for the shots. The CDC, which typically makes such recommendations, later walked back the secretary's statement, saying that healthy children could get the shot if a doctor agreed that it was needed. Moderna told the CDC it was ramping up supplies of its vaccine for the fall, according to the agency's email. But it is not approved for healthy children, and if the FDA rescinds authorization for children younger than 5, parents of healthy children will find themselves with no options. Andrew Nixon, a spokesperson for the Department of Health and Human Services, declined to comment on potential regulatory changes and said any reports before an official statement should be treated as 'speculation.' 'The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023,' Nixon said. But public health experts noted that the coronavirus is still a threat, even for otherwise healthy children younger than 2. Among children ages 6 months to 2 years who were hospitalized with COVID from October 2022 to April 2024, more than half had no underlying medical conditions, according to data from the CDC. Advertisement The vaccines have also been shown to offer modest protection against long COVID in some children. The effects are already becoming apparent. Providers have stopped ordering last year's shot, as they often do at this time of the year. Normally by this point, there would be a clear plan for the 2025-26 season. Leanne Cronic-Powell, 36, a lawyer for a software company in Medford, Massachusetts, called four clinics but could not find one that could offer the COVID vaccine to her daughter later this month. Anticipating that the shots might be difficult to find in the fall, Cronic-Powell had opted to have her 8-month-old daughter, Ripley, immunized in June, soon after she was eligible. Ripley has received two of the three Pfizer doses in the primary series but cannot receive the third, which is due Aug. 22. 'I'm really frustrated,' she said. 'It feels like we're being thwarted at every turn.' The Massachusetts Department of Public Health, when Cronic-Powell turned to it for guidance, was not any wiser. 'At this time, sadly, there is not much more we can do to help as we do not have any further information from the CDC/FDA,' a representative told her in an email Monday viewed by the Times. The path to a COVID vaccine may not be much smoother even for children at high risk. About half of American children receive their shots through the Vaccines for Children program, which provides them free of cost. But providers who are enrolled in the program are not required to carry COVID vaccines. Advertisement 'Providers already don't order a lot of COVID vaccine, so this is going to very much complicate things,' said Claire Hannan, executive director of the Association of Immunization Managers, which represents state and local officials. If providers decide not to carry the COVID shots, 'it's going to be hard to find even if you're high risk,' Hannan said. This article originally appeared in .
Business Wire
a minute ago
- Business Wire
AN2 Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business and Scientific Highlights
MENLO PARK, Calif.--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the second quarter ended June 30, 2025. 'We saw continued momentum this quarter across our boron chemistry pipeline as we look to develop high-impact drugs that address serious and overlooked conditions. In our Chagas disease program, we recently dosed the first Phase 1 cohort and announced a collaboration with the Drugs for Neglected Diseases initiative that will rapidly advance preparations for our Phase 2 study and allow us to maintain critical investments in our other programs. In melioidosis, observational data shared this quarter underscore the acute lethality of this potential biothreat, emphasizing its potential danger to homeland security and to U.S. troops serving abroad. And in NTM, we presented preclinical data highlighting the therapeutic potential of epetraborole as a once daily oral treatment against M. abscessus, a disease with an 8-year all-cause mortality rate of 45% and burdensome IV treatments that are not FDA approved for the disease. We are actively exploring plans to initiate a proof-of-concept trial in M. abscessus and will provide an update in the coming months,' said Eric Easom, Co-Founder, Chairman, President, and CEO of AN2 Therapeutics. Easom continued: 'We are also excited about recent progress in our two oncology programs generated from our boron chemistry platform, where we expect to have two development candidates within the next 12 months—a 3rd generation wild-type sparing, pan mutant-inhibitor of PI3Kα and an ENPP1 inhibitor. We see ENPP1 as an emerging immuno-oncology target with significant market potential due to its ability to enable the host immune system by turning 'cold' tumors 'hot' and halt tumor metastasis. We believe boron chemistry may offer potential competitive advantages against these targets.' Second Quarter & Recent Business Updates: Chagas Disease Commenced dosing in Phase 1 FIH clinical trial of oral AN2-502998 In August, the Company announced that it has completed dosing the first single ascending dose cohort in a Phase 1 first in human clinical trial evaluating the safety, tolerability, and pharmacokinetics of oral AN2-502998 in healthy volunteers. Oral AN2-502998 is under development for chronic Chagas disease, an infectious disease caused by the parasite Trypanosoma cruzi (T. cruzi), which affects an estimated 6-7 million people worldwide, including approximately 300,000 in the U.S. and over 100,000 in Europe. Parallel planning for a Phase 2 proof-of-concept study in patients with chronic Chagas disease is underway, and the Company expects to initiate this Phase 2 study in 2026. There are no FDA approved treatments for adults with chronic Chagas disease. The Company estimates peak annual sales potential of $1 billion, and priority review voucher eligibility if approved. Collaboration with DNDi for AN2-502998 clinical development in chronic Chagas disease In July 2025, the Company announced a collaboration with the Drugs for Neglected Diseases initiative (DNDi) to advance the clinical development of AN2's oral drug candidate AN2-502998. The collaboration provides AN2 with access to DNDi's extensive clinical trial network and expertise in Chagas disease to rapidly advance Phase 2 planning. The operational efficiencies generated from this collaboration will allow the Company to conduct a cost-efficient Phase 2 trial and preserve capital for other critical pipeline programs. Melioidosis Reported key findings from 200-patient observational study Melioidosis is a highly lethal bacterial infection caused by Burkholderia pseudomallei and is recognized by the Centers for Disease Control and Prevention (CDC) as a bioterrorism agent, underscoring its potential use as a biological weapon and its ability to cause severe disease in civilian and military populations. It is endemic in warm tropical regions of the world including areas of the Mississippi Gulf Coast, Puerto Rico and the U.S. Virgin Islands and is a Nationally Notifiable Disease, designated by the CDC for monitoring, controlling and preventing serious U.S. public health disease. In June, the Company announced key insights from its 200-patient observational study in acute melioidosis. Data from the study will inform and help optimize the design of a Phase 2 trial. The study, conducted in acute hospital settings, evaluated patients receiving standard of care antibiotics, IV meropenem or ceftazidime, tracking patients while in hospital and at 28 and 90 days. A death rate of nearly 40% (by day 90) was observed among confirmed melioidosis cases. Principal investigators observed that approximately 25% of screened patients died in the short period (~3-4 days) before a definitive diagnosis of infection was confirmed and enrollment completed. These deaths were not included in the topline mortality rate. These mortality findings highlight the serious impact of melioidosis - even with current standard of care treatment - the threat it poses as a potential bioterrorism agent, and the critical need for better treatment options. Discussions are underway with the U.S. government to fund Phase 2 development of epetraborole in acute melioidosis. If approved for the treatment of melioidosis, the Company plans to seek a priority review voucher (through the medical countermeasure pathway) and could generate revenue from U.S. and other governmental stockpiling, as well as from use as treatment in disease-endemic countries, including the U.S. Nontuberculous Mycobacteria (NTM) Lung Disease Caused by M. abscessus Presented data demonstrating epetraborole's potent in vitro and in vivo activity in M. abscessus at the Nontuberculous Mycobacteria Conference at Colorado State University In May 2025, the Company presented a poster at the Nontuberculous Mycobacteria Conference at the Colorado State University highlighting epetraborole's potent in vivo activity against M. abscessus. The compound demonstrated an MIC90 that is 256-fold more potent than what was observed in the Phase 2/3 treatment-refractory NTM MAC study, reinforcing its potential as a candidate for this high-mortality condition. M. abscessus has an estimated all-cause 8-year mortality of 45% and current treatments involve burdensome IV therapies that lack FDA approval for the condition. The Company is evaluating the potential for a proof-of-concept study in M. abscessus and will provide an update on further development in the coming months. Boron Chemistry Pipeline Continuing to advance boron chemistry compounds in oncology The Company is pursuing a number of oncology targets where we believe boron chemistry offers a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and IP, including initially ENPP1 and PI3Kα. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including CPSF3 (AN2-502998 and acoziborole) and LeuRS (epetraborole, ganfeborole and tavaborole) as well as other important FDA-approved molecules including Velcade for oncology and multiple recent beta lactamase inhibitors to address multi-drug resistant bacteria. The Company has discovered preclinical compounds with profiles that are sub-nanomolar, highly selective and have excellent oral pharmacokinetics. The Company anticipates advancing the first oncology compound into development later this year with potential clinical proof of concept data within the Company's current cash runway. The Company expects to advance its second oncology compound into development in the first half of 2026. Global Health Through non-dilutive funding, the Company continues its efforts to tackle global health diseases, including tuberculosis and malaria, with projects that are currently funded by a grant from the Gates Foundation. Selected Second Quarter Financial Results Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2025 were $3.2 million, compared to $12.1 million for the same period during 2024 due to decreased clinical trial expenses, chemistry manufacturing and controls expenses, personnel-related expenses, consulting and outside services and other expenses, primarily related to termination of the EBO-301 clinical study and corporate restructuring activities in August 2024, partially offset by increases in preclinical and research studies and expenses related to start-up activities of the Phase 1 trial in Chagas disease. General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2025 were $4.0 million, compared to $3.7 million for the same period during 2024 due to increased professional and outside services expenses. Interest Income: Interest income for the second quarter of 2025 was $0.8 million, compared to $1.4 million for the same period in 2024 due to lower cash, cash equivalents and investment balances and lower interest rates in 2025 as compared to 2024. Net loss: Net loss for the second quarter of 2025 was $6.5 million, compared to $14.4 million for the same period during 2024. Cash Position: The Company had cash, cash equivalents and investments of $71.2 million at June 30, 2025. The Company projects that existing cash, cash equivalents and investments will sustain operations into 2028 under the current operating plan. About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform. AN2 has a pipeline of boron-based compounds in development for Chagas disease, melioidosis, and NTM lung disease caused by M. abscessus, along with programs focused on targets in oncology and infectious diseases. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes. For more information, please visit our website at Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential and competitive advantage of the Company's boron chemistry platform; high-impact nature of the Company's clinical programs; the Company's approach to capital allocation and the availability of and plans to use non-dilutive funding, including the possibility that the U.S. government will not fund the Phase 2 and other future melioidosis trials; expectations regarding the Company's clinical trials, including initiation, enrollment, conduct and the timing of data and related announcements; the ability of non-human primate models to de-risk translation to human efficacy; market and sales potential; priority review voucher eligibility and registrational pathways; cash runway; continued global health programs; and other statements that are not historical fact. These statements are based on AN2's current estimates, expectations, plans, objectives and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2's ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2's clinical trials; disruptions at the FDA and other government agencies caused by funding shortages, staff reductions and statutory, regulatory and policy changes; AN2's ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results, the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities or other undesirable side effects associated with AN2's product candidates; the significant uncertainty associated with AN2's product candidates ever receiving any regulatory approvals; continued government funding of AN2's development program for melioidosis; AN2's ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2's strategic plans for its business and product candidates; the sufficiency of AN2's capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading 'Risk Factors' in AN2's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2's website at and on the SEC's website at Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. AN2 THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands) June 30, 2025 (unaudited) December 31, 2024 Assets Current assets: Cash and cash equivalents $ 18,220 $ 21,351 Short-term investments 44,696 62,267 Prepaid expenses and other current assets 4,608 2,644 Long-term investments 8,301 5,021 Other assets, long-term — 804 Total assets $ 75,825 $ 92,087 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 2,113 $ 3,317 Other current liabilities 4,870 6,921 Total liabilities 6,983 10,238 Stockholders' equity 68,842 81,849 Total liabilities and stockholders' equity $ 75,825 $ 92,087 Expand
Business Wire
a minute ago
- Business Wire
HealthWarehouse.com Reports Results for Second Quarter 2025
CINCINNATI--(BUSINESS WIRE)-- Inc. (OTCQB:HEWA) announced today that its net sales for the second quarter ended June 30, 2025, totaled $15.7 million, a 182% increase from the quarter ended June 30, 2024, resulting from 495% growth in partner services revenues. The Company reported net income of $228,000 and Adjusted EBITDA of $568,000 for the quarter. a technology company with a focus on healthcare e-commerce, sells and delivers prescription and over-the-counter medications to all 50 states as an Approved Digital Pharmacy through the National Association of Boards of Pharmacy (NABP). provides a platform focused on increasing access to and reducing costs of healthcare products for consumers and business partners nationwide. Joseph Peters, President and CEO, commented, 'Our team carried the momentum from the past nine months of rapid growth into the second quarter of 2025, resulting in continued positive financials, proving the economic scalability of our business model. We have established ourselves as a reliable service provider for high volume partners and we have shown our expertise in processing orders that require cold-chain shipping services.' continues to invest in proprietary technology to remain at the forefront of new developments and offerings in the world of healthcare, focusing on patient experience, operational efficiency, and scalability. Peters noted that the FDA has announced the end of the shortage of certain GLP1 drugs, including tirzepatide and semaglutide. That will impact pharmacies and telehealth providers like which have been offering compounded versions of those drugs while the principal manufacturers were unable to meet demand. expects to see an impact from the FDA ruling on its results for the second half of the year, starting with the third quarter. 'Fortunately, as the pharmacy world starts to focus on offerings outside of the GLP1 space, we have a robust pipeline of partner-service business, with many diversified product categories,' Peters added. 'Additionally, we are well equipped to help manufacturers launch direct-to-patient programs and are eager to develop new opportunities in that market. I am grateful for our team, as they continue to solve new problems and provide world class service to our customers.' Overview of Results for Three and Six Months Ended June 30, 2025 Net Sales: Total net sales for the three and six months ended June 30, 2025, were $15.7 million and $30.7 million, respectively, increasing by $9.9 million (171.8%) and $19.8 million (182.0%), respectively, versus the same periods in 2024. Prescription sales were $15.0 million and $29.4 million for the three and six months ended June 30, 2025, respectively, an increase of $10.0 million (196.5%) and $19.9 million (210.5%), respectively, compared with the same periods in 2024. The increase in prescription sales was due to growth in partner services revenue, offset by $908,000 and $1.6 million declines in the direct-to-consumer prescription business for the three- and six-months periods. Sales of over-the-counter products were $599,000 and $1.2 million for the three and six months ended June 30, 2025, respectively, a decrease of $44,000 (6.8%) and $122,000 (9.6%), respectively, over the same periods in 2024, primarily due to a decline in Partner Services over-the-counter sales. Gross Profit: Gross profit for the three and six months ended June 30, 2025, was $5.2 million and $9.7 million, respectively, representing increases of $2.2 million and $3.8 million, respectively, compared with the same periods in 2024. The increases were the result of higher sales offset by lower margins on our partner services prescription business. Gross margin percentages were 32.9% and 31.6% for the three and six months ended June 30, 2025, respectively, which were 18.4 and 22.7 percentage points lower, respectively, versus prior-year periods. The reduction was primarily due to lower margins in the Partner Services prescription businesses. Operating Expenses: Selling, general and administrative expenses were $4.8 million and $9.1 million for the three and six months ended June 30, 2025, respectively, which were increases of $1.6 million (49.9%) and $2.8 million (43.3%), respectively, compared to the same periods in 2024. Expense increases included increases in shipping and shipping supplies, salaries primarily related to higher direct pharmacy labor, software engineering and business development, and advertising and legal expenses. Net Income and Adjusted EBITDA: The Company reported net income of $228,000 and $406,000 for the three and six months ended June 30, 2025, respectively, compared with net losses of $344,000 and $596,000, respectively, for the same periods in 2024. Earnings before interest, taxes, depreciation and amortization ('EBITDA'), as adjusted for stock-based compensation and certain non-recurring charges ('Adjusted EBITDA'), were $609,000 for the three months and $1.2 million for the six months ended June 30, 2025. That compares with Adjusted EBITDA of $25,000 and $140,000, respectively, for the three and six months ended June 30, 2024. EBITDA and Adjusted EBITDA are non-GAAP financial measures. Definitions of these non-GAAP terms and a reconciliation to GAAP measures are provided below. Use of Non-GAAP Financial Measures Inc. (the "Company") prepares its consolidated financial statements in accordance with the United States generally accepted accounting principles ("GAAP"). In addition to disclosing financial results prepared in accordance with GAAP, the Company discloses information regarding EBITDA and Adjusted EBITDA, which are commonly used. In addition to adjusting net income or net loss to exclude interest, taxes, depreciation and amortization, including amortization of right of use lease asset, ('EBITDA'), Adjusted EBITDA also excludes stock-based compensation, and certain nonrecurring charges. EBITDA and Adjusted EBITDA are not measures of performance defined in accordance with GAAP. However, Adjusted EBITDA is used internally in planning and evaluating the Company`s performance. Accordingly, management believes that disclosure of this metric offers lenders and other shareholders an additional view of the Company`s operations that, when coupled with GAAP results, provides a more complete understanding of the Company's financial results. Adjusted EBITDA should not be considered as an alternative to net income, net loss or to net cash provided by or used in operating activities as a measure of operating results or of liquidity. It may not be comparable to similarly titled measures used by other companies, and it excludes financial information that some may consider important in evaluating the Company`s performance. About Inc. (OTCQB: HEWA), a technology company with a focus on healthcare e-commerce, sells and delivers prescription and over-the-counter medications to all 50 states as an Approved Digital Pharmacy through the National Association of Boards of Pharmacy ('NABP'). provides a platform focused on increasing access and reducing costs of healthcare products for consumers and business partners nationwide. Based in Florence, Kentucky, the Company operates America's Leading Online Pharmacy and is a pioneer in affordable healthcare. As one of the first National Association of Boards of Pharmacy Approved Digital Pharmacies, services the mission of providing affordable healthcare and incredible patient services to help Americans. Learn more at Forward-Looking Statements This announcement and the information incorporated by reference herein contain 'forward-looking statements' as defined in federal securities laws, including but not limited to Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which statements are based on our current expectations, estimates, forecasts and projections. Statements that are not historical facts, including statements about the beliefs, expectations and future plans and strategies of the Company, are forward-looking statements. Actual results may differ materially from those expressed in forward looking statements or in management's expectations. Important factors which could cause or contribute to actual results being materially and adversely different from those described or implied by forward looking statements include, among others, risks related to competition, management of growth, access to sufficient capital to fund our business and our growth, new products, services and technologies, potential fluctuations in operating results, international expansion, outcomes of legal proceedings and claims, fulfillment center optimization, seasonality, commercial agreements, acquisitions and strategic transactions, foreign exchange rates, system interruption, cyber-attacks, access to sufficient inventory, government regulation and taxation and fraud. More information about factors that potentially could affect financial results is included in audited Annual Reports and Quarterly Reports available at and prior filings with the Securities and Exchange Commission.
