Latest news with #Netherton
BBC News
2 days ago
- BBC News
Attempted murder arrests over Netherton knife attack
Three men have been arrested on suspicion of attempted murder after a man was injured in a knife attack.A man in his 30s was taken to hospital after being slashed with a knife at a house in Netherton on Merseyside at about 01:00 BST, police said. He has since been discharged. The arrested men, aged 22, 34 and 37, all from Netherton, remain in custody for Insp Ted Barr urged witnesses or anyone with information or doorbell footage to get in touch. "This was clearly a serious assault on the victim," he said. "This could have been far worse and I want to reassure the community in Netherton that we are taking this extremely seriously." Listen to the best of BBC Radio Merseyside on Sounds and follow BBC Merseyside on Facebook, X, and Instagram. You can also send story ideas via Whatsapp to 0808 100 2230.
Yahoo
10-06-2025
- Business
- Yahoo
Azitra, Inc. Announces Presentation at the 2025 BIO International Convention
BRANFORD, Conn., June 10, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that the company will present at the BIO International Convention being held June 16-19, 2025, in Boston, Massachusetts. The presentation will highlight recent updates and progress in Azitra's pipeline, including ATR-12, currently in a Phase 1b clinical trial in adult patients with Netherton syndrome and ATR-04, in development for the treatment of moderate to severe EGFRi-associated dermal toxicity in adults. Details of the presentation are as follows: Event: 2025 BIO International Convention Date and Time: Tuesday, June 17 at 12:00 PM, ET Location: Boston Convention & Exhibition Center, Room 154 Presenter: Travis Whitfill PhD MPH, Cofounder and Chief Operating Officer During the conference, Dr. Whitfill will conduct one-on-one meetings with registered investors and potential partners, showcasing the company's business and clinical development strategy, recent corporate achievements, and anticipated milestones. About Azitra, Inc. Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company's lead program, ATR-12, uses an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra's additional advanced program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S. Azitra has an open IND for its ATR-04 program in patients with EGFRi associated rash. The ATR-12 and ATR-04 programs were developed from Azitra's proprietary platform of engineered proteins and topical live biotherapeutic products that includes a microbial library comprised of approximately 1,500 bacterial strains. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the library of strains for drug like molecules. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program, the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies. Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may fail to present this abstract detailing the Phase 1/2 clinical trial or, if we are able to do so, that the abstract will be favorably received; we may experience delays in the dosing the first patient in this Phase 1/2 trial; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described or incorporated by reference in our annual report on Form 10-K filed with the SEC on February 24, 2025. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Norman StaskeyChief Financial Officerstaskey@ Investor Relations Tiberend Strategic Advisors, Nugent205-566-3026jnugent@ Media Relations Tiberend Strategic Advisors, McDonald646-577-8520cmcdonald@ View original content to download multimedia: SOURCE Azitra, Inc. 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
Yahoo
14-05-2025
- Business
- Yahoo
Azitra, Inc. to Present Abstract at American Society of Gene and Cell Therapy Highlighting Phase 1/2 Study Targeting Cancer Therapy-Associated Rash
Azitra plans to dose first patient in a Phase 1/2 trial in the first half of 2025 for its precision dermatology candidate ATR04-484, designed for the treatment of EGFR inhibitor-associated rash BRANFORD, Conn., May 14, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that it will present a poster describing the Phase 1/2 clinical trial of ATR04-484 for EGFR inhibitor ("EGFRi")-associated rash at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT). ASGCT is being held May 13-17, 2025, in New Orleans, Louisiana. Details of the presentation are as follows: Event: American Society of Gene and Cell Therapy Location: New Orleans Ernest N. Morial Convention Center, New Orleans, Louisiana When: May 15, 2025; 5:30-7:00PM CT Title: A Novel Staphylococcus epidermidis Compound for the Topical Treatment Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Dermal Toxicity Presenter: Mary Spellman, MD, Chief Medical Officer Registration: "The Annual Meeting of ASGCT is an important conference for researchers and industry leaders who are seeking to develop next-generation cell and gene therapies for patients in need," said Mary Spellman, MD, Chief Medical Officer of Azitra. "We are excited to present supporting evidence for the clinical development of topical ATR04-484 and our Phase 1/2 clinical study design, in anticipation of initiating dosing for the first patient in the coming month." About Azitra, Inc. Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company's lead program, ATR-12, uses an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra's additional advanced program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S. Azitra has an open IND for its ATR-04 program in patients with EGFRi associated rash. The ATR-12 and ATR-04 programs were developed from Azitra's proprietary platform of engineered proteins and topical live biotherapeutic products that includes a microbial library comprised of approximately 1,500 bacterial strains. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the library of strains for drug like molecules. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program, the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies. Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may fail to present this abstract detailing the Phase 1/2 clinical trial or, if we are able to do so, that the abstract will be favorably received; we may experience delays in the dosing the first patient in this Phase 1/2 trial; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described or incorporated by reference in our annual report on Form 10-K filed with the SEC on February 24, 2025. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Norman StaskeyChief Financial Officerstaskey@ Investor Relations Tiberend Strategic Advisors, Nugent205-566-3026jnugent@ Media Relations Tiberend Strategic Advisors, McDonald 646-577-8520cmcdonald@ View original content to download multimedia: SOURCE Azitra, Inc. Sign in to access your portfolio
Yahoo
13-05-2025
- Business
- Yahoo
Azitra, Inc. Announces Q1 2025 Results and Provides Business Updates
BRANFORD, Conn., May 13, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the quarter ended March 31, 2025, and provided a business update. Q1 2025 and Recent Business Highlights Announced acceptance of poster detailing the Phase 1/2 clinical trial of the ATR-04 program in EGFR inhibitor ("EGFRi")-associated rash at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting Entered into Purchase Agreement for up to $20 Million in Partnership with institutional investor Alumni Capital LP, to fund clinical pipeline Announced closing of two public offerings raising a total of $2.2M "The start of 2025 has been a vital period for Azitra as we build towards key milestones expected by mid-year for our first-in-class, precision, live biotherapeutic candidates designed for major undertreated dermatological diseases," said Francisco Salva, CEO of Azitra. "For ATR-12, our lead program targeting the rare, chronic and devastating Netherton syndrome, we expect to provide initial safety data from our Phase 1b trial in the first half of 2025 with topline results expected by year-end 2025. There are no approved treatments for Netherton syndrome, and we believe this novel approach has potential to be life-changing for these patients." Salva continued: "Also by mid-2025, we look forward to dosing the first patient in our Phase 1/2 trial with our ATR-04 program, which contains a live biotherapeutic product candidate containing an isolated, naturally derived S. epidermidis strain being developed for the treatment of EGFRi-associated rash. EGFRi-associated rash is a dermatologic toxicity that often accompanies EGFRi treatments for cancer, impacting approximately 150,000 patients in the United States annually. These severe skin conditions can interfere with cancer treatment efforts, often causing significant physical and psychological discomfort for patients. Given the importance of EGFRi therapies to the cancer industry, Azitra was invited to present an update of our ATR-04 Phase 1/2 trial at ASCO 2025, which is the most prestigious cancer research conference in the world." Salva concluded: "The remainder of 2025 is expected to be a milestone-rich period for Azitra during which we look forward to showcasing the potential of ATR-12 and ATR-04, as well as our unique, proprietary platform for delivering engineered proteins using topical live biotherapeutic products." Pipeline and Anticipated Milestones 1H 2025: Initial safety data from first set of Netherton syndrome patients in the ATR-12 Phase 1b trial 1H 2025: First patient dosed with for EGFRi-associated rash in a Phase 1/2 trial for ATR-04 YE 2025: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients Financial Results for the Quarter Ended March 31, 2025 Research and Development (R&D) expenses: R&D expenses for the quarter ended March 31, 2025, were $1.3 million compared to $1.5 million for the comparable period in 2024. General and Administrative (G&A) expenses: G&A expenses for the quarter ended March 31, 2025, were $1.9 million compared to $1.5 million for the comparable period in 2024. Net Loss was $3.1 million for the quarter ended March 31, 2025, compared to $2.9 million for the comparable period in 2024. Cash and cash equivalents: As of March 31, 2025, the Company had cash and cash equivalents of $3.2 million. About Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company's lead program, ATR-12, uses an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra's additional advanced program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S. Azitra has an open IND for its ATR-04 program in patients with EGFRi associated rash. The ATR-12 and ATR-04 programs were developed from Azitra's proprietary platform of engineered proteins and topical live biotherapeutic products that includes a microbial library comprised of approximately 1,500 bacterial strains. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the library of strains for drug like molecules. For more information, please visit Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of (i) our provision of initial safety data and topline results for the phase 1b trial for our ATR-12, (ii) the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program and (iii), the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies. Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may experience delays in the provision of initial safety data and topline results for ATR-12 or, if we do, that such data may not be favorably received, we may fail to present this abstract detailing the Phase 1/2 clinical trial or, if we are able to do so, that the abstract will be favorably received; we may experience delays in the dosing the first patient in this Phase 1/2 trial; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described or incorporated by reference in our annual report on Form 10-K filed with the SEC on February 24, 2025. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Norman StaskeyChief Financial Officerstaskey@ Investor Relations Tiberend Strategic Advisors, Nugent205-566-3026jnugent@ Media Relations Tiberend Strategic Advisors, McDonald 646-577-8520cmcdonald@ Condensed Statement of Operations(Unaudited) Three months Ended March 31,2025 2024Operating expenses: General and administrative$ 1,850,138 $ 1,488,527Research and development 1,250,1001,472,970Total operating expenses 3,100,2382,961,497 Loss from operations (3,100,238)(2,961,497) Other income (expense): Interest income 37,1647,609Interest expense (1,293)(915)Change in fair value of warrants 14328,255Other expense (4,121)(6,327)Total other income 31,89328,622) Net loss before income taxes (3,068,345)(2,932,875) Income tax expense -- Net loss$ (3,068,345) $ (2,932,875)Net loss attributable to common shareholders$ (3,068,345)(2,932,875)Net loss per Share, basic and diluted$ (0.23) $ (4.32)Weighted average common stock outstanding, basic and diluted 13,171,516678,885 Condensed Balance Sheets(Unaudited) March 31, December 31,2025 2024Assets Current Assets: Cash and cash equivalents$ 3,206,710 $ 4,554,719Other receivables 103,046101,896Prepaid expenses and other current assets 561,798571,675Total current assets$ 3,871,554 $ 5,228,290 Property and equipment, net 621,012653,957Other assets 1,415,3251,476,555Total assets$ 5,907,891 $ 7,358,802 Liabilities, and stockholders' equity Current liabilities: Accounts payable$ 558,924 $ 490,255Current financing lease liability 16,45616,066Current operating lease liability 237,647255,177Accrued expenses 467,394614,359Total current liabilities 1,280,4211,375,857Long-term financing lease liability 5,84310,105Long-term operating lease liability 213,765274,161Warrant liability 238381Total liabilities 1,500,2671,660,504Stockholders' equity Common stock 1,498763Additional paid-in capital 65,040,29663,263,360Accumulated deficit (60,634,170)(57,565,825)Total stockholders' equity 4,407,6245,698,298Total liabilities and stockholders' equity$ 5,907,891 $ 7,358,802 View original content to download multimedia: SOURCE Azitra, Inc. 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Yahoo
06-05-2025
- Business
- Yahoo
BioCryst Pharmaceuticals Inc (BCRX) Q1 2025 Earnings Call Highlights: Strong ORLADEYO Sales ...
Total Revenue: $145.5 million for the quarter. ORLADEYO Revenue: $134.2 million, with $120.2 million from the US. Operating Expenses (excluding stock-based compensation): $102.9 million, up from $93.6 million in the same quarter last year. Operating Profit: $21.2 million for the first quarter of 2025. Net Income: Slightly positive for the quarter. Cash Position: $317 million at the end of the quarter. Debt Reduction: Paid down $75 million, reducing outstanding debt to $249 million. Annual Revenue Guidance for ORLADEYO: Raised to between $580 million and $600 million, representing 33% to 37% growth over last year. Non-GAAP Operating Expense Guidance: $440 million to $450 million for the year. Warning! GuruFocus has detected 6 Warning Signs with BCRX. Release Date: May 05, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) reported a strong first quarter with revenue of $145.5 million, driven by ORLADEYO sales. The company raised its annual revenue guidance for ORLADEYO to between $580 million and $600 million, indicating 33% to 37% growth over the previous year. BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) achieved a significant improvement in the paid rate for ORLADEYO, reaching 84%, which was expected to take three years but was accomplished in four months. The company is on track to be profitable on a full-year basis in 2025, a year earlier than previously planned. BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) paid down $75 million of its debt, reducing outstanding debt to $249 million and saving approximately $23 million in interest payments over the life of the debt. The typical revenue jump in Q2 will be less pronounced than in prior years due to the accelerated revenue capture in Q1. Operating expenses increased to $102.9 million, up from $93.6 million in the same quarter last year, driven by commercial expansion and support activities. The company faces challenges in conducting clinical trials for rare diseases like Netherton syndrome due to the lack of existing therapies and organized patient advocacy. The path to achieving $1 billion in global revenue by 2029 for ORLADEYO is still dependent on capturing more patients and maintaining growth momentum. The pediatric launch of ORLADEYO, while promising, has not yet been quantified in terms of revenue impact, and the uptake dynamics remain uncertain. Q: Can you provide insights into the potential pediatric launch for ORLADEYO and its impact on the market? A: Charles Gayer, Chief Commercial Officer, explained that there are approximately 500 pediatric HAE patients in the US, with at least 200 potentially suitable for prophylactic therapy. The introduction of an oral option like ORLADEYO could change the treatment landscape, as there is no preference for injectables among children. The expectation is that ORLADEYO will become the market leader due to its ease of administration compared to injectables. Q: What are the expectations for the DME program's first readout, and what would be considered a successful outcome? A: Helen Thackray, Chief Research & Development Officer, stated that the focus is on safety, tolerability, and the effect on retinal thickness. The goal is to observe a reduction in retinal edema, with preclinical data suggesting a quick response. A significant reduction in edema would be a positive indicator for the program's success. Q: How did BioCryst achieve such a significant improvement in the paid rate for ORLADEYO, and is this sustainable? A: Charles Gayer highlighted that two-thirds of the improvement was due to the Inflation Reduction Act, which helped Medicare patients afford their prescriptions. The commercial segment also saw improvements due to better preparation and real-world evidence supporting ORLADEYO's efficacy. The current paid rate is expected to be sustainable, with further incremental improvements anticipated. Q: With profitability pulled forward, how does this impact BioCryst's investment strategy, particularly for the early-stage pipeline? A: Jon Stonehouse, CEO, noted that the programs are already fully funded to proceed as quickly as possible. The company is focused on cleaning up the balance sheet, as evidenced by the recent $75 million debt paydown, and will continue to look at similar opportunities as cash flow improves. Q: What are the expectations for the Netherton syndrome program, and what are the key milestones? A: Helen Thackray explained that the program is designed to address the fundamental pathology of Netherton syndrome. The Phase 1 trial will assess drug levels in the epidermis and clinical impact, with initial data expected by year-end. The goal is to see normalization of the skin and reduction in itch, with potential dose escalation if necessary. 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
