Latest news with #Results
Time of India
6 days ago
- General
- Time of India
Avinuty Result 2025: Avinashilingam Institute declares UG, PG, PG-Diploma & Ph.D. results at avinuty.ac.in; students can direct link here
Avinuty Result 2025 declared Avinuty Result 2025: The May 2025 semester results of Avinashilingam Institute for Home Science and Higher Education for Women (Deemed to be University) were officially declared today at 4:30 PM. Students can now access their results through the university's official portal. The announcement comes as a significant update for undergraduate and postgraduate students across various departments. The timely publication reflects the institute's continued commitment to academic excellence and transparency. How to Check Avinuty May 2025 Semester Results Online • Visit the Official Results Portal: Navigate to the Avinashilingam Institute's official results page: • Select the Relevant Examination: On the results page, locate and click on the link corresponding to your course and semester. • Enter Your Roll Number: Input your Roll Number in the provided field. Ensure the number is accurate to avoid errors. • Submit and View Your Results: Click the Submit button. Your result will be displayed on the screen. • Download and Print: For future reference, download and print your result. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Switch to UnionBank Rewards Card UnionBank Credit Card Undo It's advisable to keep a copy until you receive the official marksheet. Direct link to check the Avinuty Semester Result 2025 The evaluation process was completed smoothly, and technical arrangements ensured a stable result portal for students. As of 5:30 PM, most students have successfully viewed and downloaded their results without major issues. Students who face any difficulty in accessing the results or wish to report discrepancies are encouraged to reach out to their respective department offices or use the official support mechanisms provided by the university. The Avinashilingam Institute, located in Coimbatore, Tamil Nadu, is a Category 'A' deemed university, re-accredited with an 'A+' Grade by NAAC, and recognized under Section 12B of the UGC Act. The university continues to uphold its legacy of empowering women through quality higher education. Ready to navigate global policies? Secure your overseas future. Get expert guidance now!
Time of India
30-05-2025
- General
- Time of India
AP SSC Supplementary Result 2025: BSEAP Class 10 supply results expected soon at bse.ap.gov.in — check details
The Andhra Pradesh Board of Secondary Education (BSEAP) is anticipated to announce the AP SSC Supplementary Result 2025 soon on Students who appeared for the Class 10 supplementary exams should monitor the official website. Expected between June 15 and June 17, students can download their marks memo and verify details, needing 35% marks to pass. Tired of too many ads? Remove Ads Where to check AP SSC Supplementary Results 2025? Tired of too many ads? Remove Ads How to download AP SSC Supplementary Result 2025? Visit the official site – On the homepage, find and click on the 'Results' link Select the 'AP SSC Supplementary Results 2025' option Enter your roll number or hall ticket number Click 'Submit' Your result will be displayed on the screen Download it and take a printout for future reference Details to verify on the AP SSC Supply Marksheet 2025 Student's name Roll number / Hall ticket number Subject-wise marks Total marks Grades obtained Grades obtained Pass/fail status Date of birth and other personal details AP SSC Supply Result 2025: Minimum passing marks The Andhra Pradesh Board of Secondary Education (BSEAP) is expected to release the AP SSC Supplementary Result 2025 soon on its official website — Students who appeared for the Class 10 supplementary exams are advised to keep an eye on the official site and affiliated result portals for real-time per previous trends, the board generally announces the BSEAP SSC supply results within 15 days of the last examination. Since the final supplementary paper was conducted on May 28, students can expect the AP SSC supply results 2025 between June 15 and June declared, students can access their Class 10 supply exam results and download the AP SSC marks memo 2025 from the following official websites:Follow these steps to download your BSEAP SSC supply result 2025:Students must carefully check all information mentioned in their SSC supplementary marks memo. If any discrepancy is found, they should contact the BSEAP board immediately. The following details should be verified:To qualify the SSC supplementary exam, students must secure at least 35% marks in each subject. Note that no rounding off is allowed, so candidates must meet the exact cut-off in every AP SSC Supplementary Results 2025 are expected to be out shortly. Students are advised to keep their hall ticket numbers handy and check the official portals regularly. For accurate and updated information, only refer to BSEAP-approved websites.
Yahoo
14-05-2025
- Business
- Yahoo
Q1 2025 Dare Bioscience Inc Earnings Call
MarDee Haring-Layton; Chief Accounting Officer; Dare Bioscience Inc Sabrina Johnson; President, Chief Executive Officer, Secretary, Director; Dare Bioscience Inc Douglas Tsao; Analyst; H.C. Wainwright Catherine Novack; Analyst; Jones Research Will Hidell; Analyst; Brookline Capital Markets Operator Welcome to the conference call hosted by Dare Bioscience to review the company's first quarter 2025 financial results and to provide a business update. This call is being recorded. My name is Gail, and I will be your operator today. With us today from Dare are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer. please proceed. MarDee Haring-Layton Good afternoon, and welcome to the Dare Bioscience Financial Results and Business Update Call for the quarter ended March 31, 2025. Today, we will review our results, discuss developments and expectations for our pipeline and portfolio and discuss our recently announced expanded business strategy, leveraging a dual path strategy where we commercialize our proprietary formulations via 503B compounding while continuing to seek FDA approval as well as taking steps toward launching certain solutions as branded consumer health products that do not require a prescription, in all cases, to bring solutions to market as soon as practicable. I would like to remind you that today's discussion will include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended March 31, 2025, which was filed today and our Form 10-K for the year ended December 31, 2024. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, May 13, 2025. Dare undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. I will now turn it over to Sabrina. Sabrina Johnson Thank you, and thank you, everyone, for joining the call today. We are excited to announce today that in addition to our proprietary Sildenafil cream formulation, we are taking action to make 3 more solutions for women available commercially, 2 vaginal probiotics in 2025 and our proprietary monthly hormone therapy in 2026. Making our hormone therapy solution available next year creates a commercial opportunity for Dare in the estimated up to $4.5 billion compounded hormone therapy market and enables women to have access to an evidence-based solution. As you can appreciate, 4 on-market products will accelerate revenue generation and provide a path to profitability. We expect to start recording revenue in the fourth quarter of this following the health care and biotech sectors knows that the first quarter of 2025 has been marked by distractions and disruptions for the overall health care and biotech sector. I'm proud that Dare is uniquely positioned to cut through the noise and deliver value to all of our shareholders, women, health care providers and investors who are all stakeholders in Dare. Today, biopharmaceutical companies with relatively low-risk assets, a competitive advantage and a path toward near-term revenue are positioned to offer upside. We believe that is Dare today. Women's health is ripe for returns because it has been underfunded and with our recently announced expanded business strategy, we believe we are strongly positioned to deliver value and returns to all of our stakeholders with a business model that is nimble, allowing us to rapidly commercialize multiple products via multiple channels. We're no longer only seeking FDA approval. We're leveraging a dual path strategy where we commercialize via 503B compounding while continuing to seek FDA approval. We're also taking steps towards launching certain solutions as branded consumer health products that do not require a prescription. At Dare, women's health isn't just a our sole purpose. And to our knowledge, we are the only publicly traded company focused solely on developing therapeutic products for a broad range of conditions affecting women, contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. And to our knowledge, we are the only publicly traded company leveraging all available paths to bring evidence-based solutions to market, reflecting where and how women are getting and paying for their care. as an FDA-approved treatment, as a compounded product, as a consumer health product that does not require a prescription available via telehealth, online or via an in-person visit with her health care provider. Our portfolio is over the last months and the next months, we look forward to continuing to provide updates regarding strategic partnerships and collaborations to facilitate access to Dare on market brands for women across multiple channels. Today, I'll provide some perspective on these channels and the strategic relationships we're seeking to enter into to provide women with access to our evidence-based solutions from their trusted sources, where they get their medication and their health care solutions. I'll also provide a refresher on our potential first-in-category monthly intravaginal hormone therapy, a product candidate we've been developing to really shift the hormone therapy landscape. Gaps in solutions for menopause symptoms have given rise to an explosion of untested supplements and therapies. We believe in delivering hormone therapy that has been rigorously studied to meet the needs of women and their keep in mind that bringing our proprietary Sildenafil cream formulation and our monthly intravaginal hormone therapy solution to market via 503B compounding will not impact the regulatory process or commercial opportunity for an FDA-approved product. Rather, if successful, it accelerates the availability of these proprietary formulations for health care providers and women and it accelerates revenue. It can also provide real-world evidence and experience that we would seek to utilize to streamline the path to an FDA approval of these potential first-in-category candidates. I'll also give some background on the vaginal probiotics that we also intend to bring to market this year. Both of which, by the way, were identified via a grant we received from the Gates Foundation to evaluate the global probiotic manufacturer community and identify evidence-based formulations from manufacturers following GMP.I'll also give a brief update on Ovaprene, our novel investigational hormone-free monthly intravaginal contraceptive, the ongoing enrollment in the pivotal Phase III contraceptive efficacy study and our Data Safety Monitoring Board interim assessment, which is scheduled for July of this year as well as other therapeutic development pipeline updates on Sildenafil and Dare -HPV, which is our investigational product for the treatment of human papillomavirus infection, which is the virus that causes cervical cancer. Before I provide additional updates, I'm going to first turn it back over to our Chief Accounting Officer, Mardee, to review first quarter 2025 financial results. MarDee Haring-Layton Thanks, Sabrina, and thanks, everyone, for joining us today. I would now like to summarize Dare's financial results for the quarter ended March 31, 2025, which I will refer to as the first quarter. Put simply, Dare's business strategy is to assemble and advance a portfolio of differentiated treatment solutions that address meaningful unmet needs we've identified in women's health and then to monetize the value of our portfolio of clinical and regulatory advances over the near and long term. The investment required to build and advance a portfolio includes corporate overhead, portfolio acquisition and maintenance costs and ongoing research and development or R&D expenses. During the first quarter of 2025, our general and administrative expenses were approximately $2.3 million, which is a 14% decrease compared to Q1 2024 due primarily to reduced stock-based compensation expense, reduced professional services expense and reduced continue to maintain a lean and focused team and are managing overhead costs closely. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory and other development program costs were approximately $2.3 million, which is a 31% decrease compared to Q1 2024. Our comprehensive loss for the quarter was approximately $4.4 million. We ended the first quarter with approximately $10.3 million in cash and cash equivalents and a working capital deficit of approximately $9.4 million. Dare remains committed to being creative, collaborative and opportunistic to build shareholder value, including by making certain proprietary formulations in the DA portfolio accessible via a prescription through the FDA's 503(b) of May 12, 2025, we had approximately 8.9 million shares of common stock outstanding. We encourage investors to review the more detailed discussion of our financial -- financial condition, liquidity, capital resources and risk factors in our Form 10-Q for the quarter ended March 31, 2025, filed today. I would now like to turn the call back over to Sabrina. Sabrina Johnson Thank you. So as we all know, and we've been discussing, we are a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority. Our vision is to meet the increasing demand for evidence-based treatments with both uncompromising scientific rigor and rapid responsible commercialization. As a leader in women's health, we continuously hear from the health care providers and women themselves about the urgent need for faster access to trusted evidence-based treatments that women can afford. We believe that innovation does not have to start from that can address decades of unmet needs in women's health often already have clinical proof of concept or existing safety data for the active ingredient. We seek to leverage these data and insights in order to bring solutions to market rapidly in a fiscally responsible manner and in ways designed to optimize access for women. With growing awareness around menopause, sexual health and vaginal health, the conversation is shifting, but access to real evidence-based solutions still lags behind. As awareness grows, so does the demand for treatment options, and we are seeking to meet this moment by ensuring women have access to solutions that are not only needed but are evidence-based. Like our Sildenafil cream formulation, our investigational hormone therapy, DARE-HRT1 is being developed in response to feedback from women and their health care despite the fact that the Menopause Society recommends hormone therapy and recommends delivering estrogen and progesterone together for women with intact uterine and despite the fact that the Menopause Society states that nonoral routes of administration may offer potential advantages, there is no non-oral hormone therapy that meets those criteria that a woman can administer directly. DARE-HRT1 is just that. It's an intravaginal ring that a woman can self-administer just once a month. And like our Sidenail cream formulation, their HRT1 has been evaluated in rigorous toxicology studies and completed pharmacokinetic studies demonstrating the systemic levels of the hormones being administered as measured in the blood of postmenopausal women, our clinical study findings specific to this proprietary formulation have been published in peer-reviewed journals. Making our hormone therapy solution available next year via 503B compounding creates a commercial opportunity for Dare, as I mentioned, in the estimated up to $4.5 billion compounded hormone therapy market and enables women to access this evidence-based as with the menopause sector, gaps in solution in the vaginal health sector have similarly led to an explosion of untested supplements and therapies. The 2 vaginal probiotics that we also intend to bring to market this year, as I noted upfront, were identified via a grant we received from the Gates Foundation last year. It was a grant to evaluate the global probiotic manufacturer community and to identify evidence-based solutions and formulations for manufacturers following GMP. These 2 products were designed to restore a healthy vaginal microbiome and have been evaluated and demonstrated effective in clinical studies in women outside of the United States in restoring a healthy vaginal microbiome, but they are not yet available here. And we want women in the also have access to these evidence-based vaginal probiotics, and we intend to make them available as branded consumer health products later this year. So this is a good place for me to address the strategic partnerships and collaborations we intend to establish to facilitate access to Dare's on-market brands for women across multiple channels for both the prescription products via 503B compounding and branded consumer health products. As I stated at the beginning of the call, our goal is to bring evidence-based solutions to market, reflecting where and how women are getting and paying for their care. As I mentioned, that might be an FDA-approved treatment, a compounded product, a consumer health product that does not require a prescription, might be available via telehealth, other online platforms via an in-person visit with their health care provider. We want women to access these products, these Dare on-market brands from the source they trust and that reflects where and how they are currently selecting their solutions and getting their care what does that mean in terms of our partnering strategy? It means partnering with telehealth providers that reflect Dare's mission of challenging the status quo and putting women's health first and that are committed to providing evidence-based solutions. It means partnering with online retailers that provide complementary offerings. It means collaborating with online prescription fulfillers so that our formulations are available on their platforms. And it means participating in medical conferences and continuing medical education programs so that the health care community is broadly aware of these evidence-based solutions as they consider their treatment simply, it means meeting women where they are, wherever they are. Therefore, don't expect just one strategic partnership, expect several. The delivery of health care and the purchase of health care solutions has changed dramatically over the last 5 years, and we would not be true to our corporate tagline, which is daring to be different if we did not lean into the latest trends in accessible health care and put partnerships and collaboration in place that reflect those trends. Finally, I should also note that like our Sildenafil cream and our monthly intravaginal hormone therapy formulations, there are other proprietary formulations in the DAA portfolio that we can make accessible via prescription through the 503(b) pathway. We are actively evaluating the dual path approach for some of our other proprietary formulations -- so that dual path again is to continue to pursue FDA approval of a product candidate for a treatment indication while simultaneously bringing that formulation to market via the 503(b) pathway as soon as taking this approach as part of our responsibility to women, to the health care community and to our shareholders and because we believe women should not have to wait for needed medical treatment solutions while they continue to pursue an FDA-approved path. Over the next months, we'll continue to provide additional updates, so please stay tuned. I'm now going to talk through our anticipated 2025 milestones for our therapeutic product candidates. I'll highlight Ovaprene, Sildenafil cream and DR-HPV in that regard. Ovaprene, again, is our novel investigational hormone-free monthly intravaginal contraceptive, whose commercial rights are under a license agreement with Bayer is ongoing in the pivotal Phase III contraceptive efficacy study of vovaprenren. Recall that we announced an up to $10.7 million foundation nondilutive grant in November 2024, which supported the addition of 5 new investigator sites in the first quarter of this year. We've been really pleased with the pace of enrollment at those sites to date. But I will say, don't ask me because it's too early for me to predict enrollment rate for the remainder of the study. I will share, though, that we do not anticipate that the NICHD, those NIH contracted study sites will resume enrolling new participants under their existing NIH of the interim data by the study Safety Data Monitoring Board, which is an independent group of experts, which evaluates the safety and integrity of the study is scheduled for this July, July 2025, and we will provide an update following that meeting. Recall overall that the primary objective of the study is to assess the typical use pregnancy rate over 13 menstrual cycles or the estimated pearl index for Ovaprene. Secondary objectives are to assess Ovaprene's 13-cycle use cumulative pregnancy rate, safety, acceptability, product fit and ease of use and assessments of vaginal health. If successful, we expect the study to support the submission of a premarket approval application for Ovaprene to the FDA as well as regulatory filings in Europe and other countries worldwide to allow marketing approvals of Ovaprene. Regarding sildenafil as an investigational cream formulation of Sildenafil, which is the active ingredient in the oral erectile dysfunction drug for men for topical on-demand administration to treat female sexual arousal disorder, we have continued our interactions with the FDA regarding the planned Phase III study and expect more updates on Phase III design, development and collaboration strategy throughout targeting submission of additional information requested by the FDA, along with the protocol and the statistical analysis plan for the Phase III study to get those to the FDA by the end of the second quarter of 2025. That's really immediately -- our immediate next step on this development program on our path to pursuing an FDA approval. For Dare-HPV, I will remind that in 2024, we were selected to receive an award of up to $10 million for the development of Dare-HPV, which is an innovative investigational treatment for HPV-related cervical diseases. And with the support of that funding, we're advancing DR-HPV towards a Phase II clinical study, which is supported with that funding. Essentially, all cervical cancer cases worldwide are caused by HPV despite the fantastic advancement in HPV screening and vaccination in the U.S., an estimated 100,000 women are still treated for cervical precancer each year and an estimated 4,000 women are expected to die from cervical cancer in 2024. Today, cervical precancers are monitored until they reach a late stage since the most common treatment is surgery, which removes parts of the cervix. And that surgery is associated with an increased risk of preterm birth and sexual dysfunction. So it's not recommended for patients with fertility concerns. In the U.S., about 10% of women with HPV infection on the cervix will develop long-lasting HPV infections that put them at risk for cervical has the potential to be the first FDA-approved pharmaceutical intervention that could treat both genital HPV infections in women as well as late-stage cervical dysplasia and treat that infection, which would change the paradigm around how HPV-related cervical diseases are clinically managed today, preventing surgery, stopping the spread and transforming care for this critical health issue. And DARE-HPV is reflective of the type of development program we really like to advance at Dare. It's a first-in-category product, but it leverages active pharmaceutical ingredients that have been approved to treat other viral infections. Specifically, Dare-HPV is an investigational proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert with the potential to be this first-in-category treatment for HPV infection and HPV-related cervical diseases. We look forward to continuing to expect activities necessary to enable submission of the IND application to the FDA and for a Phase II randomized placebo-controlled double-blind clinical study of DIRE-HPV for clearance of high-risk HPV infection in women, all supported with the funding we received under that $10 million excited to be able to provide more updates in the coming months on our therapeutic development programs as well as our progress as we work to commercialize some of the most potentially disruptive candidates for the health and well-being of women in decades. I'd like to now turn the call over to the operator for Q&A. Operator (Operator Instructions)Douglas Tsao, H.C. Wainwright. Douglas Tsao I guess, Sabrina, you said that we should anticipate several different partnerships in terms of sort of the compounded distribution and products. I'm just curious, would that be unique partnerships for each product? Or could you potentially have multiple partnerships for an individual product? Sabrina Johnson Yes, that's a great question. Thanks for asking for the clarification. Both. So first of all, I want to start out that we would intend to have multiple partnerships for an individual product because we want to make sure, as I mentioned, that, that product is available in as many places as possible that makes sense in terms of where women are getting their care and that, like I said, meet our objectives in terms of criteria around that platform having the right commitment and the right access to women on their platforms and where they might have complementary products as well. So for an individual product, absolutely expect several relationships to support that brand, having as wide access as possible and as it makes sense for that particular product and that particular channel being also, as I think may be intuitive, but just in case it's not. These platforms that have built fantastic relationships with the patients and consumers that use their platforms, obviously, it's very compelling for them to have access to new products and especially evidence-based treatments and opportunities to partner with DAA, which is a leading pharmaceutical developer in the area of women's health. And so there are also interesting opportunities where DAA products, multiple DAA products could be available on an individual platform as well. So over the coming -- as I said, over the coming months, expect more news from us around this, more announcements around this. But the goal is to very simply make sure that these evidence-based treatments are available for the women who are seeking them and for the health care providers that want to provide that means we want to make sure they are on as many platforms and via as many channels as possible. And that's what the relationships and collaborations and partnerships will reflect. Douglas Tsao And I guess I'm just curious, when you think about -- and this is maybe specific to sildenafil cream, target being sort of in the market by the end of the year. Is there much that you need to do to ensure that there is sufficient manufacturing capacity for the product by year-end? Sabrina Johnson Another great question. So we definitely want to make sure that our 503B collaborator on this. So under 503B, just taking a step back for a second for everyone's benefit, under 503B, the product, the statutes, the product needs to be manufactured at a registered 503B facility. And therefore, we need to support our 503B facility in how to make our proprietary Sildenafil cream, right, get them that ready. This is GMP is not compounding at a pharmacy. This is at an outsourcing facility, which are regulated by FDA's GMP rules and subject to FDA inspection. And therefore, there are activities that need to happen for that manufacturer to be prepared to provide the product at the scale that we need. And that's why it's fourth quarter and not yesterday that we were launching this product. And that's really what that timing is in addition to that, though, what that gives us is some nice time between now and then to do a lot of work around provider education and medical education with the support of the medical institutions that are very focused on sexual health of women and other platforms that are focused on education of providers that are focused in that field. And so what it allows us to do in terms of other preparations is to use this time to make sure that we're supporting those providers with education around disease state and also education around our specific Sildenafil cream formulation. And so those are really the 2 -- the 3 key sets of activities that are happening between now and this product being commercially available are: one, supporting our 503B manufacturer with all the support they need to make sure they're up and running, to your point, at the scale that we want to support this exciting brand. Two, it's the partnerships and collaborations that we've been talking about to ensure the availability of the product in multiple channels and platforms. And the third is that provider I will say a group of us are going to be at ACOG at the end of this week, which is the American College of Obstetrics and Gynecology Conference. It's the first time Dare has a booth at the conference and really we're there for education and to provide some education around what Dare is doing and what's coming soon from our portfolio. Douglas Tsao And Sabrina, if I can, one more. I'm just curious because I think you've been talking to potential partners around Sildenafil in terms of the sort of traditional FDA-approved track. I'm curious if you've gotten feedback from potential partners and reaction broadly from others in the sort of traditional pharmaceutical industry to you taking this step. Sabrina Johnson Yes, we definitely have. And I would say the feedback has been fantastic and complementary in terms of our really being open-minded and thoughtful and creative in how we get this product out there as quickly as possible. Everyone recognizes in pharma more than anyone that drug development can take a very long time, right, decades in some cases. And we've received a lot of super positive feedback from the industry and those players in terms of how we found a way to accelerate getting a product to market that health care providers are anxious to have. And so that women aren't waiting and they can actually get something that's evidence-based and has been studied for a condition for which they are seeking an so the feedback has really been very, very positive. And it's definitely part of, frankly, what's inspired us to really look more broadly across our portfolio, the feedback from the health care providers, the feedback from women and importantly, the feedback from our peer drug developers. Operator Catherine Novack, Jones Research. Catherine Novack Sabrina, this is Leona on for Catherine. I'll just start with Sildenafil Phase III, what additional information has the FDA requested? And then for Ovaprene, can you provide any additional information on the potential outcomes of the interim assessment? Will you have the opportunity to increase the sample size if needed? Sabrina Johnson Yes, both great questions. So starting with Sildenafil, yes, to put that in context. So in April, we received additional input and information request from the FDA regarded our patient-reported outcomes psychometrics. And I don't expect everyone to know what psychometrics means. But basically, that it's about your questionnaires, the test VPS reliability, is it content valid or fit for are specific terms that are used around patient-reported outcomes and specifically related to both what was done in the Phase II, but also importantly, what should be done in Phase III as part of that overall final validation. And that's something, by the way, that was anticipated to be part of the Phase III plan and has been discussed with the FDA. So as you can appreciate, the psychometric analysis, it has bearing on the efficacy endpoint and also the statistical analysis plan and just what's included in the Phase III study. So we've submitted information to the FDA in response to this. We're targeting submission of additional request information along with the actual protocol incorporating that and the statistical analysis plan for the Phase III, incorporating that to the targeting by the end of this quarter. And that's why I'd say this is -- while we would like to target commencement and are targeting commencement of the Phase III study this year, that's really pending us getting this into the FDA and then obviously, their review and then any additional feedback we might get in response of this because obviously, we want the Phase III trial that is ultimately conducted to be very clearly reflective of everything the FDA needs to see in it in order for it to be supportive of registration. And then in terms of Ovaprene and the Data Safety Monitoring Board meeting that's scheduled for this July. So as the name is, it is a safety meeting. They're really looking at the safety and the integrity of the what their charter requires them to do. And -- in terms of -- it's not an analysis and a planned review for sample size, but that's not their goal. And in fact, there will not be any statistical assessment of the primary endpoint of the study, and that's the kind of thing that would be needed if there was going to be a sample size change. It's really just looking at safety. Now having said that, and I've said this a few times, which I think is sometimes surprising to people, but 2 this is an open-label study. It is open label. Everyone is on Ovaprene. And two, a pregnancy in a contraceptive study is considered an adverse event. So they will be looking at those data in that context, but there will be no assessment of the actual Pearl index, which is the primary endpoint in the there is no opportunity, therefore, to do any kind of sample study size changes based on that because there won't be any assessment of the primary endpoint. Catherine Novack Great. And if I could just ask a couple more add-ons. For the compounding drugs, are you pursuing a dual path for all 4 of those products? I guess you've kind of answered this, but what kind of marketing and KOL outreach are you doing for the ones that were mentioned today, the probiotics and then the hormone therapy? Sabrina Johnson Yes. So to clarify, so sildenafil and the hormone therapy are both dual path products. So there are prescription. They'll be available via compounding under 503(b) statute as a prescription, and then we are pursuing a dual path and that we are continuing our efforts and activities to support ongoing development of those products through -- for both of them, it would be the 505(b)(2) regulatory pathway to get a treatment indication. For the vaginal probiotics, those are consumer health for products of that nature, while one could certainly choose to pursue an FDA approval for products of that nature to get some sort of treatment claim if they wanted, we're not interested in that. These are really products designed to restore a vaginal microbiome. And so that is not necessary, and there's no other work we're going to be doing on those other than making those available in the United States. And in terms of efforts to kind of educate and support the primary effort right now on the part of Dare is very much focused around Sildenafil. -- and then there'll be more efforts on the hormone therapy next good news is it's all the same KOLs and it's all the same medical societies that really focus on both sexual health and menopause. And so we'll be focusing on education programs right now around Sildenafil and its availability. But we're also doing a lot to just awareness around Dare and what we are doing as a leader in ensuring that these evidence-based treatments take it to women and making sure that the health care providers are educated on them. So that will really be our focus in the near term, a lot of focus around Sildenafil and as we get into next year, even more focus on the hormone therapy as well. And then obviously, we're making -- the consumer health brand is a little bit of a different channel, although we do think that there are a lot of health care providers that are very interested in having a natural evidence-based solution that they can make available to their we will opportunistically make sure that they're educated on those as well. Operator (Operator Instructions)Will Hidell, Brookline Capital Markets. Will Hidell Sabrina, quick question regarding Ovaprene, the trial. Does the grant received in November cover cost to add additional sites? I know you mentioned in the Q about adding potentially 2 or 3 new sites. Does that grant cover those costs? Sabrina Johnson Yes. Thank you. Great question, too. Yes. So the way the grant works, it is really designed to cover the cost of adding a certain number of additional subjects to the we've focused initially on 5 sites, which, frankly, at the rates they're going, can be sufficient to add those additional subjects in a very reasonable time frame. So we're going to look at whether there are other sites that we need to open as well. Right now, we're really happy with the pace of enrollment at the 5 sites, but we definitely have some flexibility to add some additional sites as well. Will Hidell Okay. Great. And then R&D came in a little lower than last quarter. Should we expect that number to continue going forward? Or should we see an uptick in that? Sabrina Johnson Right now, thanks for asking for that clarification, by the way. Right now, the only ongoing study at this time is the Ovaprene study. And as we were just talking about, the activities right now are really funded with the grant funding we receive. We do have sometimes, and Mardee kind of alluded to this, other costs associated with Ovaprene and those were in, I think, the Q as well related to manufacturing, just other things that we're doing, obviously, to support the product and certain other activities that we might want to kind of lean into even related to the study, sometimes like advertising, things like that. But what you've seen in terms of those trends is really reflective of the fact that we don't have other ongoing studies at this so until we do, that's the kind of trend you should expect to continue to see until we have other studies going on at this time. Will Hidell Okay. If I could ask one more. With Sildenafil cream, you mentioned, I think, last quarter that you needed about $1 million to get the 503B operations going. Does that apply to the additional products? Or will there be an additional cost? Sabrina Johnson That's another great question. Yes, that's very specific to Sildenafil. So that's really the cost associated with supporting our 503B manufacturer with the start-up tech transfer activities like that, that are needed to produce GMP Sildenafil cream product. There would be additional costs associated with production activities and tech transfer activities associated with the hormone therapy product. They're in a similar range as that, but it's because it's for those similar kinds of basically to ensure that the manufacturer under GMP has the opportunity to do all the things that are required under GMP and has all of the right equipment and things like that. So as we get closer, the Dare-HRT1, the hormone therapy product is really targeted for next year. So as we continue to progress on that and get closer, we'll be able to give even better guidance around that and what those costs are. But it's the same kind of ballpark, right? We're talking single-digit millions and not tens of millions. Operator That concludes our Q&A session for today. I would like to turn the call back over to Sabrina Martucci Johnson for any additional or closing remarks. Sabrina Johnson Great. Well, thank you all for taking the time this afternoon and special thanks for the really thoughtful questions. I'll close with basically the same comment I made upfront. repetition is important sometimes, which is that Dare is uniquely positioned to cut through the noise and deliver value to all of our stakeholders, women, health care providers and investors. Today, biopharmaceutical companies with relatively low-risk assets, a competitive advantage and a path towards near-term revenue are positioned to offer as I said upfront, we believe that is Dare today. I can't stress enough that women's health is ripe for returns. It has been so underfunded and fragmented. And with our recently announced expanded business strategy, we believe we're uniquely positioned to deliver that value and returns to all of the stakeholders. With this business model that I hope you will agree is nimble, allowing us to rapidly commercialize multiple products via multiple on-market products will accelerate revenue generation and provide a path to profitability, and we expect to start recording revenue in the fourth quarter of this year. The portfolio is compelling. And over the next months, as I've said, we look forward to providing updates regarding strategic partnerships and collaborations to facilitate access to our on-market brands for women across multiple channels. Thank you for listening today and for your support. Operator Thank you, everyone, and that concludes today's call. Thank you all for joining. You may now disconnect. Have a nice day ahead.
Yahoo
24-04-2025
- Business
- Yahoo
Golar LNG Limited – Q1 2025 results presentation
Golar LNG's 1st Quarter 2025 results will be released before the NASDAQ opens on Wednesday, May 21, 2025. In connection with this, a webcast presentation will be held at 1:00 P.M (London Time) on Wednesday May 21, 2025. The presentation will be available to download from the Investor Relations section at We recommend that participants join the conference call via the listen-only live webcast link provided. Sell-side analysts interested in raising a question during the Q&A session that will immediately follow the presentation should access the event via the conference call by clicking on this link. We recommend connecting 10 minutes prior to the call start. Information on how to ask questions will be given at the beginning of the Q&A session. There will be a limit of two questions per participant. a. Listen-only live webcast linkGo to the Investors, Results Centre section at and click on the link to "Webcast". To listen to the conference call from the web, you need to have a sound card on your computer, but no special plug ins are required to access the webcast. There is a 'Help' link available on the webcast pages for anyone who may have issues accessing. b. Teleconference Conference call participants should register to obtain their dial in and passcode details. This process eliminates wait times when joining the call. When you log in, you can either dial in using the provided numbers and your unique PIN, or select the 'Call me' option and type in your phone number to be instantly connected to the call. Use the following link to register. Please download the presentation material from (Investors, Results Centre) to view it while listening to the conference. If you are not able to listen at the time of the call, you can assess a replay of the event audio for a limited time on (Investors, Results Centre). This information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading in to access your portfolio
Times of Oman
06-03-2025
- Politics
- Times of Oman
General Education Diploma results to be announced on Sunday
Muscat: The Sultanate of Oman's Minister of Education, Her Excellency Dr. Madiha bint Ahmed Al-Shaibani, has announced the general indicators for the first semester examination results for the General Education Diploma and its equivalents for the 2024/2025 academic year. The results reveal a pass rate of 80.76% for the standard General Education Diploma, with 54,943 students participating. Notably, other categories achieved higher pass rates, including 91.05% for private bilingual schools, 100% for the Sultan's Armed Forces Technical College and Islamic Studies, 88.52% for Special Education, and 99.27% for Vocational and Technical diplomas. Students will be able to access their results from 4 PM on Sunday, March 9, 2025, via text message services provided by Omantel, Ooredoo, and Vodafone, by sending their candidate numbers to 90200. Subsequently, the results will also be available on Oman's educational portal. The Ministry of Education emphasised its commitment to maintaining the integrity of the examination process. Examinations were conducted at 366 centres across Oman in a calm and conducive environment. However, 20 breaches of examination regulations were detected, and the ministry has taken necessary measures in accordance with existing regulations, conducting thorough investigations to ensure fairness before applying appropriate penalties. Students wishing to request re-evaluations of their examination papers can submit applications through Oman's educational portal, specifically under the 'Examination Results Review for Year 12' link, between 9th March and 16th March 2024. The ministry has made it clear that no applications will be accepted after this deadline, and they have reiterated their commitment to ensuring that all students' rights are protected.
