Latest news with #TimLee
Yahoo
23-05-2025
- Health
- Yahoo
Invivyd Announces Inclusion of PEMGARDA® (pemivibart) in National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas
WALTHAM, Mass., May 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced that PEMGARDA® (pemivibart), its investigational monoclonal antibody, has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas. NCCN joins the Infectious Disease Society of America (IDSA) that updated its COVID-19 guidelines in August 2024 to recommend the use of PEMGARDA (pemivibart) for pre-exposure prophylaxis (PrEP) in moderately to severely immunocompromised adults and adolescents (aged 12 or older) at risk for progression to severe COVID-19 when predominant regional variants are susceptible to pemivibart. This inclusion in the NCCN Guidelines recognizes PEMGARDA as a potential option for PrEP against COVID-19 in patients with B-cell malignancies. Immunocompromised patients may not mount an adequate immune response to vaccination. 'Managing B-cell lymphoma is inherently challenging for patients, and the added risk of severe COVID-19 further complicates their care,' said George Yaghmour, MD. 'The inclusion of PEMGARDA in the NCCN Guidelines is an important development, providing clinicians with a valuable tool to guide treatment decisions. It helps protect vulnerable patients from COVID-19, allowing them to stay out of the hospital, continue their cancer care, and focus on their recovery.' 'We are honored that NCCN has acknowledged the role of PEMGARDA in helping protect one of the most vulnerable patient populations - those with compromised immune systems due to B-cell lymphomas - especially in light of ongoing COVID-19 threats,' said Tim Lee, Chief Commercial Officer at Invivyd. 'This recognition reflects the growing confidence in the therapeutic potential of PEMGARDA, and reinforces our commitment to immunocompromised patients including those facing difficult to treat lymphomas, particularly as COVID-19 remains a year-round threat, with another surge expected this summer.' The NCCN's recommendation is based on the unmet need in patients with B-cell lymphomas, many of whom experience reduced vaccine efficacy and are at elevated risk for COVID-19-related complications. PEMGARDA is a monoclonal antibody engineered to retain activity against circulating SARS-CoV-2 variants and is currently authorized under Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for PrEP of COVID-19 in certain patients with moderate-to-severe immune compromise. The updated NCCN Guidelines are now available on the NCCN website and serve as an important resource for oncology providers making evidence-based treatment decisions. They reflect growing clinical and real-world evidence supporting the use of passive immunization to complement vaccination strategies in high-risk oncology populations. NCCN is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to defining and advancing quality, effective, equitable, and accessible cancer care and prevention so all people can live better lives. About PEMGARDAPEMGARDA® (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd's investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC and LP.8.1. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells. PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. PEMGARDA is not authorized for use for treatment of COVID-19 or post-exposure prophylaxis of COVID-19. Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccinations, should receive COVID-19 vaccination. In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination. Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse reactions included systemic infusion-related reactions and hypersensitivity reactions, local infusion site reactions, and infusion site infiltration or extravasation. For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning. To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Further, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges. Additionally, certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA, and PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants. The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies. About Invivyd Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit to learn more. Trademarks are the property of their respective owners. Cautionary Note Regarding Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'anticipates,' 'believes,' 'could,' 'expects,' 'estimates,' 'intends,' 'potential,' 'predicts,' 'projects,' and 'future' or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the potential of PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise; PEMGARDA as a potential option for PrEP against COVID-19 in patients with B-cell malignancies; the future of the COVID-19 landscape; the company's commitment to immunocompromised patients; the potential of PEMGARDA to retain activity against circulating SARS-CoV-2 variants; the company's devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company's forward-looking statements and you should not place undue reliance on the company's forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: how long the EUA granted by the FDA for PEMGARDA will remain in effect and whether the EUA is revised or revoked by the FDA; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; the success of the company's in-house sales force, and the company's ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize PEMGARDA; changes in expected or existing competition; changes in the regulatory environment; the outcome of the company's engagement with regulators; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; the timing, progress and results of the company's discovery, preclinical and clinical development activities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of the company's product candidates based on neutralizing activity in nonclinical studies; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitope that pemivibart targets remains structurally intact; whether the company's product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the company's reliance on third parties; clinical trial site activation or enrollment rates; the complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; the company's ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading 'Risk Factors' in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, each filed with the Securities and Exchange Commission (SEC), and in the company's other filings with the SEC, and in its future reports to be filed with the SEC and available at Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. 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Yahoo
16-05-2025
- Business
- Yahoo
Q1 2025 Invivyd Inc Earnings Call
Katie Falzone; Senior Vice President, Finance; Invivyd Inc Marc Elia; Independent Chairman of the Board; Invivyd Inc Tim Lee; Chief Commercial Officer; Invivyd Inc Robert Allen; Chief Scientific Officer; Invivyd Inc Mark Wingertzahn; Senior Vice President of Clinical Development and Medical Affairs; Invivyd Inc William Duke; Chief Financial Officer; Invivyd Inc Kyle Yang; Analyst; Jefferies Operator Thank you for standing by and welcome to Invivyd's first quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. (Operator Instructions) I would now like to hand the call over to Katie Falzone, SVP, Finance. Please go ahead. Katie Falzone Thank you, operator. A short while ago, we issued a press release announcing our Q1 2025 financial results and business highlights. That press release and the slides that are being used on today's webcast can be found in the Investors section of the Invivyd website under the Press Release and Events & Presentation sections, respectively. Today's discussion will be led by Marc Elia, Chairman of the Vivid Board of Director. He is joined by Tim Lee, Chief Commercial Officer; Bill Duke, Chief Financial Officer; Dr. Robert Allen, Chief Scientific Officer; and Dr. Mark Wingertzahn, Senior Vice President of Clinical Development. During today's discussion, we will be making forward-looking statements concerning, among other things, our corporate and commercial strategy, our research and development activities, our regulatory plans, certain financial expectations, our future prospects, and other statements that are not historical facts. These forward-looking statements are covered within the meaning of the Private Securities Litigation Reform Act and are subject to various risks, assumptions, and uncertainties that may change over time and cause our actual results to differ materially from those expressed or implied today. These forward-looking statements speak only as of the date of the call, and Invivyd assumes no duty to update such statements. Additional information on the risk factors that could affect Invivyd's business can be found in our filings made with the US Securities & Exchange Commission, including our most recent Form 10-K and 10-Q, which are also available on our website. I will now turn the call over to Marc. Marc Elia Good morning and thank you all for joining us. Turning to slide 4. The first quarter and our early second quarter has been a very busy and productive time marked by transition. Our commercial organization is now wholly internalized, new in the field, and reflects an intentional bet by this management team that our new internal team will drive broader adoption of PEMGARDA with associated commercial results. While it is early, our leading indicators are promising, and we remain targeting near-term breakeven with continued revenue growth and operating expense management. Scientifically, we're very pleased with what we see in the evolutionary journey of SARS-CoV-2 relative to the epitope we are exploiting with Pemivibart and as now we see no obstacle to long-term growth in our commercial PEMGARDA business. We have secured access to additional non-dilutive capital to grow if certain conditions and milestones are met, and we are expanding our pipeline to multiple disease areas in which we believe our scientific approach can add value to patients in need. Specifically, we have added discovery programs against new viral targets with the potential for identifying best in-class medicines for diseases outside of COVID-19. Our previous work in influenza continues at a low intensity, but bird flu with pandemic potential has not meaningfully emerged, and in the very recent short time, we have actually seen more US deaths from measles outbreaks than we have seen from avian influenza over the past year or so. At this point, it is reasonable to expect that trend to continue, and our focus has shifted accordingly toward early measles discovery. Last year, we initiated a new discovery program for an RSV monoclonal antibody that Robbie Allen, our CSO will describe in a bit more detail. RSV presents a very clear, high-value competitive landscape and some molecular properties we believe we can target to generate a potential best-in-class monoclonal antibody with blockbuster commercial potential. As we grow and expand our COVID franchise, we will accordingly want to make targeted financially responsible investments in discovery that can yield drugs we can capitalize for development either in concert with the equity markets or with potential strategic partners. There has been no shortage of interest in our work from potential partners, particularly those with a vaccine footprint. It's important to note that our corporate goals, including targeting near-term breakeven, are audacious by design and reflective of our integrated strategic and operational choices. In the big picture, we want to create as much medical value for patients in society as fast as possible, and then we want to translate that value into per share shareholder value as efficiently as possible. In an easy biotech financing environment characterized by low interest rates and long return horizons with blue skies for investors, it is much easier for companies to raise large quantities of dilutive equity that may enable a mediocre or far-fetched biological premise to survive to the next catalyst. But such a business strategy rarely translates into long-term per-share compounding of shareholder value. We are taking the opposite approach and trying to be highly disciplined with our expenditures and capital base to the maximum extent, and not just because these days the biotech investing backdrop and equity cost of capital has been tougher. We've been taking our approach because we see full operational proof of concept in our ability to make medicines rapidly and efficiently, and we wish to exploit that advantage, which we see as unique in the industry as we grow our business so that our shareholders can benefit accordingly. Turning to slide 5, in the bigger social picture, it is important to note that our fundamental corporate strategy reflects a great many macro-level realities that have also undergone transition, specifically a US election result and new public health leadership focused on chronic disease who are moving in directions on multiple fronts that comport well with our business strategy. It's a quick reminder, Invivyd was started based on a simple reality that SARS-CoV-2 was a unique virus designed to prey on a distinctly vulnerable human population. It was clear early that vaccines for COVID-19 disease would work over the short term, but that waning responses would be problematic for every person, especially for immunocompromised persons. And on top of that, immune-invasive Omicron viruses have added another headwind, as has the growing underlying burden of long COVID. More, given the handling of COVID-19 vaccine policies, there is a regrettable secular shift underway with respect to American attitudes toward vaccination as a whole. Reviewing the last year's events with respect to COVID-19 vaccines, such a shift is indeed regrettable, but perhaps not surprising. Monoclonal antibodies can be designed to overcome challenges with vaccination. After all, we are all born immunocompromised and preloaded with a suite of non-self-monoclonal antibodies from our mothers. And yet, in the pursuit of freedom from the burden of SARS-CoV-2, our regulatory and public health complex for four years was single-mindedly focused on exposing humans serially and broadly to spike protein, largely in mRNA form, in an effort to get us our protective antibodies the hard way rather than, as mom and mother nature might suggest, providing mechanisms for humans to access additional antibody support so that humans don't need to choose between dangerous infections and increasingly debatably effective vaccinations. Unique in the industry, Invivyd has now fully developed through multiple placebo-controlled RCTs, two monoclonal antibodies against SARS-CoV-2, adintrevimab against ancestral viruses like Delta, and now pemivibart against contemporary immune-invasive Omicron viruses. More in our recent canopy Phase 3 clinical study assessing safety, immuno bridging, and exploratory clinical efficacy analysis, we are reporting clinical results from a modern American population, specifically a population that has pre-existing immune experience or seropositivity in both study and placebo arms. To some observers of the vaccine industry, conducting such studies is undoable or unthinkable. And yet to us and others in the monoclonal antibody business, those studies are business as usual. You will see elements of our recent Citizen Petition to the US FDA that focuses in on these issues because to us there is clearly within reach a mechanism to scale access to monoclonal antibodies if and when regulators so choose. As you will see later in this morning's call, we have multiple parallel conversations with public health authorities designed to expand the consequences of our discovery and development work. With that, I'll turn the call over to Tim Lee to discuss our commercial progress in the quarter. Tim Lee Thank you, Marc, and good morning all. Turning to slide 6. The first quarter cemented our transition from a contracted largely outsourced model designed to hit a short seasonal window to a best-in-class commercial footprint to drive consistent growth via an in-house team. We did not have a fourth quarter call, so it's been six months since I've had the opportunity to speak with the broad investor community and it's worth sharing a few general observations from the fall and winter before we walk through key indicators. Marc and the team asked me to create a best in class commercial effort to put behind PEMGARDA and our future molecules. I'm pleased with what we've done so far, but in many ways, we are just getting started. First, we spent an enormous amount of time with healthcare providers and health systems simply re-educating on the existence of monoclonal antibodies as an alternative therapy available today. What began as a commercial interest largely driven by those who knew and anticipated PEMGARDA now beginning to see institutional orders that are just beginning to reflect the underlying medical need. Protocols, pathways, real-world experience and word of mouth in the clinical community are still in the early innings, and we expect real growth to follow as this familiarity rises. Second, healthcare providers began with real skepticism on the ability of PEMGARDA to navigate virus evolution, particularly filing the FDA's misguided and harmful insertion of inaccurate third-party virology data into the PEMGARDA fact sheet last fall. The combination of our communication of the underlying science and along with the empirical reality of the attractive continuing activity is now gaining notice and belief. Third, the understanding of COVID-19 of the community has undergone a notable evolution. Most healthcare providers are now moving beyond the pandemic era, concept of an acute respiratory syndrome, the SARS part of SARS-CoV-2 and now see acute infection and corresponding respiratory disease as part of a much broader, more insidious, long-term health challenge. We are, and we believe now on the forefront of educating these clinicians on why patients who are battling cancer, navigating transplant, or who lack sufficient immune cells to mount a response to vaccination need a protective option. The untapped market potential ahead of us remained numerically vast. As we execute in our new posture, we expect to see a meaningful acceleration in product growth. Now I can get into the specifics of execution on slide 7. You see here the top-level metrics accompanied by three of the structural elements we have installed at Invivyd. We have moved to a focused, trained, in-house team, ending our relationship with contract representatives. We have established and built a culture of accountability and measurement. We have substantially refined our messaging and believe that we are recognized as leaders in the COVID-19 field by healthcare providers and institutions broadly. All of these elements are the keys to each successful launch in pharmaceutical growth-initiator nation over my career. We're also beginning to make some progress around numerous fronts including contracting. While not contemplated in the very early launch, we are receiving scaled interest from organizations who wish to derive value from commitments to our large ordering and are pleased to be working with them. We're seeing ourselves placed in pathways, protocols, and guidelines nationally, leading to a deeper understanding of PEMGARDA. Turn to sliding slide 8 shows the continued steady growth in our commercial reach. While Q1 revenues dipped from Q4, we believe much of that is attributable to the lack of feet on the street. In January and February, as we trained up and deployed, hired our new sales team, encouragingly, we've seen strong revenues thus far in Q2, including, for example, our biggest-ever commercial day and biggest-ever commercial week. Day by day, the highs are getting higher, and the lows are getting higher as well. This is the hallmark of ongoing growth. Turn to slide 9. We would note that professional societies and guideline writers are taking notice of our work. In addition to the IDSA guidelines, we now have PEMGARDA in the NCCN guidelines for B-cell lymphomas, which is a substantial US population which deserves high-quality protection. We routinely see from KOLs at medical conferences an awareness of non-relapsed death, for example, among patients who undergo CAR-T therapy or deep immune ablation to manage lymphomas, and infectious disease deaths is a major contributor to that. With an infectious disease, COVID-19 is again a dominating contributor to that. Moving to slide 10. Of course, in contrast to other infectious diseases, COVID is ever present and characterized by periodic waves, while the sales of COVID-19 treatments are highly influenced by surges and disease and we saw that clearly among certain bigger pharmaceutical companies in their Q1 earnings calls. Prevention via monoclonal antibody may be a bit more predictable and steady. COVID is always a threat for these populations. As we go into the warmer months, we tend in the US to see waves of COVID-19 among the southern states and we're launching a targeted digital campaign regarding the likely summer surge, accordingly. Finally, on slide 11. On pricing, we took in March a modest price increase, and still PEMGARDA remains one of the lowest priced antibodies ever launched. Obviously, the original pricing analysis contemplated larger volumes, and potentially lower risk and lower acuity patients, and especially consider the potential for COVID-19 treatment. With treatment off the table for the moment, we took a small price increase to better reflect the value this medicine brings to populations in need. Note, the price increase only took effect in March and will be updated by CMS beginning in July. Next slide, please. We're pleased that PEMGARDA continues to be available through EUA and maintain focused commitment on serving the immunocompromised community. I'll now turn the call over to Robbie to discuss some of our progress in research and development. Robbie? Robert Allen It's an exciting time to be an infectious disease prevention and treatment as the central authorities in the United States reconsider the state of the world for COVID-19 and beyond. I'll begin on slide 14 by commenting on our now multi-year work with antibodies directed against the receptor binding domain or RBD of the SARS-CoV-2 spike protein. This is obviously a validated target and has been targeted repeatedly by our colleagues and competitors and other companies who would like to produce highly effective treatments and preventatives for COVID-19. The challenge they and we faced and that we believe we are overcoming is evolutionary. Invivyd's proprietary technologies are designed to yield antibody medicines that target special real estate on a biological target in motion such as SARS-CoV-2. So far, pemivibart has been a total success on that front when we, back of the envelope, calculate the sheer number of mammalian SARS-CoV-2 infections and consider the quantitative dynamics of infections, the fidelity of the SARS-CoV-2 polymerase, et cetera. We began to estimate that the virus has explored quadrillions of molecular variants over the past years, and throughout the epitope that defines the pemivibart binding site has remained structurally intact. Accordingly, the product potency as assessed in best-in-class industrial systems has remained accordingly stable. Reassuringly, of course, for our pipeline molecule 2311 -- VYD2311, the same is true on EC50 values are holding more stable and much more potent levels. In fact, neither the measured potency nor any change for VYD2311 would be visible if we placed our neutralization data onto the chart at the bottom of the slide 14. Why? Slide 15 shows a graphical depiction of the SARS-CoV-2 spike protein with a blue area shaded indicating the pemivibart epitope. Genetic and structural change observed over time at each amino acid residue in the spike is represented by intensity, yellow for minor, orange for moderate, and reddish for substantial change. You will note some yellow in a few spots of our epitope. But that change was all in the Omicron transition. Ever since then, three years, which can be in some ways considered a new phase of the pandemic or a very different endemic phase, our binding site has remained quiescent. More, as vaccination rates have dropped, pressure applied to the RBD at the population level has also dropped. Even more intriguing data out of the Bloom Lab at Fred Hutchinson demonstrates that children who have not been vaccinated, but who have been primarily infected by XVB virus variants appear to generate antibodies suites directed more towards the internal domain and away from RBD. While these NTD mutations are in keeping with the known immune-invasive properties of Omicron variants, there appears to be less evidence of selective pressure that those classically and historically antigenic sites on RBD near the pemivibart binding site and viruses isolated from these more recent childhood infections. In short, we feel very good about continued PEMGARDA activity over the long term based on the observed stability of the pemivibart epitope. Slide 16 provides a little more color on a discovery program we are moving through now related to RSV. Respiratory syncytial virus is a major medical burden, and there's a well-developed commercial category devoted to the use of monoclonal antibodies to prevent infection in neonates in children under two years at risk from seasonal RSV. At present, nirsevimab or Vifordis is the class-leading antibody, although pavilizumab is still used and Merck's clesrovimab has a near-term PDUFA date. The two more contemporary antibodies have certain strengths and liabilities, and variation of the target of protein makes the RSV landscape an excellent opportunity to see if our platform can generate an attractive medicine to compete with the class leaders. In our screening and engineering, we can establish certain parameters designed to yield best-in-class properties, and we will look forward to updating on our progress later this year. Slide 17 provides further detail on our recently announced measles discovery program. By degree, measles shares some of the same features as COVID and RSV in terms of multiple circulating variants that require an engineered, broadly neutralizing monoclonal antibody, but which also presents a highly validated antibody target considering the generally understood efficacy of, for example, both MMR vaccine and IVIG in the post-exposure prophylaxis setting. We have begun our work and our goal would be a tool useful for the treatment of acute infection and also useful in post-exposure or even pre-exposure prophylaxis use cases. We will look forward to reporting on our progress before the end of this year. I'll now turn the call over to Mark Wingertzahn and Marc Elia to discuss clinical and regulatory. Mark Wingertzahn Thanks, Robbie. Good morning, everyone. In early February, we reported our initial progress with VYD2311, our next generation antibody designed to improve pemivibart. As a reminder on slide 19, all Invivyd COVID-19 antibodies share identical scaffolding, and generally, our discovery product process works such that each successive monoclonal antibody is a minor but essential tweak from the last. This process results in molecules that are near identical in terms of amino acid sequence, in fact, generally changed about to a similar or even lesser extent than, let's say, mRNA COVID vaccines from one generation to the next. With VYD2311, we are not trying to solve a problem related to variation or some threats to our pemivibart activity, rather, we are trying to engineer more medically and commercially attractive features into our medicines. Slide 20 quickly outlines our first in-human dose and route of administration ranging clinical trial designed to provide maximum forward flexibility for our go to markets and regulatory conversations. You can see the cohorts on the slide and the concepts behind assessing them initially. We will be wrapping up the study soon and we will be pleased to provide an update in next week's on our progress. Turning to slide 21, it reminds us very quickly the properties of VYD2311 relative to the pemivibart and what we think those properties allow for. It is our belief that 2311 can be a major step forward for people sick with COVID-19 and people highly vulnerable to COVID-19, whether immunocompromised or not. VYD2311 represents a potential step change in accessibility and scalability for protection compared to PEMGARDA and may present the opportunity to also create a highly efficient and effective treatment. With that, I'd like to turn the call back to Mark Elia, who will discuss our regulatory experience with our COVID-19 treatment EUA request and some next steps. Marc. Marc Elia Thank you, Marc. As previously mentioned, we've been watching evolution at HHS and FDA with great interest. One of the key messages new HHS and FDA leadership has sent has been the desire for greater transparency, especially as it relates to communication between FDA and industrial sponsors. At this time, we have not seen any convention emerge on this front among our colleagues in industry, nor do we have any guidance on this topic from the agency. However, we are aligned with the notion that transparency is a generally good thing for regulators, patients, sponsors, and citizens. With that in mind and given the sheer volume of correspondence companies like ours have with FDA, we are today beginning by providing direct excerpts and data from one recent correspondence back in February, specifically the declination by the legacy Biden FDA of our application for expansion of our EUA to include treatment of active mild to moderate COVID in immunocompromised persons with no treatment options. This action generated many questions to our company from HCPs and patients, and we hope that today's presentation provides some answers. Importantly, we believe our presentation today reflects both the core of the scientific review by the agency and the bulk of their communication to us on the topic and would resemble in some ways the major points the agency might render to, for example, an advisory committee, if that were an operative forum. We are including our rebuttals to those points, which ultimately will build to our intended next steps. Importantly, at Invivyd, we are Americans and taxpayers, and some of us are patients too, in addition to industrial sponsors, and so we view our partnership with FDA as fundamentally collaborative on behalf of patients in need. Slide 22 describes the operative background. Immuno bridging of antibodies for COVID-19 has its roots in a December 2022 joint EMA FDA webinar attended by regulators and academic and industrial experts, including Invivyd, and was devoted to accelerating COVID-19 monoclonal antibody development. In our case, our immuno bridging prototype molecule adintrevimab went through full Phase 3 registrational RCTs for both prep and treatment of COVID-19, and as such, adintrevimab represents a biophysical profile well associated with demonstrated placebo-controlled clinical efficacy. Industry, academic, and regulatory confidence in sVNA titer or clinical antibody antiviral activity is sufficiently high to use that surrogate as a way to bridge from one clinical dataset to a new molecule without the need for full pre-authorization clinical studies, just as we did for our prep authorization. From a regulatory perspective, it was clear in 2022 and has been clear for the last three years that EUA was the pathway FDA preferred or believed was the best fit with what was understood to be a short, useful life of all COVID-19 monoclonals. This is, of course, a contrast of vaccines which enjoy full approval and sPLA updates on the basis of similar comparative titers. Either way, in the spring of 2024, a bridging EUA for treatment seemed to be a structure that might suit both our and FDA's interest sets, depending on the nature of the titer bridge, just as was the case for a prep authorization. The clear desire from the agency throughout has been for what they would consider quote, conservatism, unquote, or the highest possible antiviral titers, and therefore antibody dose to satisfy some of the epistemological limitations of immuno bridging. This is an understandable desire. If you remember that the first job of the agency is assurance or confidence and likely clinical benefit rather than stewardship of a medicine's overall profile. There are, of course, consequences to the degree of assurance required by the agency that takes some careful thought in unpacking, which is where we'll spend some time today. It is an important exercise in part for reasons embedded into our citizen petition. There is a wide gap between the assumptions and habits of [CBER] and [Sedar] respectively, as between assurances traditionally required of COVID vaccine versus assurances traditionally required for COVID monoclonal antibodies and we believe regulatory evolution is required for the benefit of patients in need. A few more background points. First, pemivibart and adintrevimab, despite being near identical molecularly, have very different potencies and hence different routes of administration and doses, which means their PK and PD profiles cannot overlap but can be easily compared to one another visually and quantitatively. Second, the proposal for EUA expansion was for immunocompromised persons for whom alternative therapies are inaccessible or not clinically appropriate, so the choice here is between pemivibart or nothing. Third, we will not touch much on the pemivibart safety profile in this overview, both because pemivibart was and remains authorized for use by people who are well, which would seem to create a safety pathway for use by people who are sick, and because the bulk of FDA feedback relates to the science of assurance of efficacy benefit in immuno bridging. Slide 23. The major FDA finding on the application for treatment presented in terms that are drawn straight from the EUA statute is that they are unable to reasonably conclude that the known and potential benefits of pemivibart in treatment outweigh the known and potential risk. They offered four specific scientific conclusions related to assurance of clinical benefit in the immuno bridging exercise, which we have paraphrased here and will present in more detail on the next slide. Slide 24 depicts curves and comparison between adintrevimab and pemivibart PK and PD expressed as sVNA titer or clinical antiviral activity, the primary basis for immuno bridging. On the upper left chart, you can see that that intrevimab being administered intramuscularly, starts with very low circulating titers and rises slowly over five to seven days toward its peak. By contrast, pemivibart is dosed intravenously and so begins instantly very high and then settles over time. You can read below the FDA interpretation of the comparative curves, which they describe as quote, similar to or higher than, unquote adintrevimab for only three days, after which it is less than. And you can see a table in the upper right expressing the ratio of those two curves over various increasingly longer time periods. The agency here is justifiably focused on whether pemivibart delivers comparative titers to adintrevimab for the longest possible time. Next slide, 25, conveys our perspective on this primary immuno bridging. In contrast to FDA description, we see adintrevimab titers as much higher than, or comparable to adintrevimab for four days, then modestly below for day five, after which the pemivibart titers settle below adintrevimab, but are of course still quite high compared to nothing for many days and then weeks, given the half-life of the molecule. Why are we at Invivyd so interested in five days? Three reasons. First, over five days, adintrevimab conferred the majority of its measured virologic benefit compared to placebo, even starting at very low titers. Second, treatment alternatives, Paxlovid and Lagevrio, are five-day regimens themselves, after which, of course, they stop and confer zero antiviral activity. And third, as a general statement, treating early in the course of an infection of COVID-19 is associated with improved outcomes. So to us, that five-day duration comparison is rather interesting, and the seven-day comparison is attractive. Although we agree that conferring long-term antiviral activity to help with persistent shedding or viral rebound is a wonderful potential benefit of using long-acting antibodies in a treatment setting. Finally, to us, while an immuno bridging analysis like this one compares a predicate antibody to a new antibody, of course, for patients in need today, the actual choice in front of FDA is between the new antibody and nothing at all, to which we will return in a moment. Slide 26, next slide, depicts one of two conceptually and substantively similar meta-analysis presented to the agency. In this case, you can see that pemivibart is not among the most potent antibodies ever developed for COVID-19, which we understand and agree with. It is, however, well within the range of effective mab titers and would provide antiviral activity a good bit above sotrovimab used to treat COVID-19 to great effect in the pandemic phase of COVID-19. Also on this chart, on the right side, -- excuse me, the left side of the curve, you will see convalescent plasma titers. Convalescent plasma, interestingly enough, retains a treatment EUA, and you can see that the range of antiviral activity conferred by convalescent plasma is far below both sotrovimab and pemivibart. Nonetheless, the FDA notes here that they would wish pemivibart to be nudged more to the right to sit among other mabs, irrespective of the fact that moving rightward appears to have a de minimis predictive effect on expected clinical outcomes. Slide 27 presents our view on this point. Moving rightward may confer some benefit to patients, and we may be able to do it with newer molecules. But alas, we are once again not picking between all of these molecules as if any of the comparators currently exist. The only active molecules depicted on this chart are pemivibart and the components of convalescent plasma well to the left. Further, agency leadership was well aware and communicated to us in the past that antibodies have been consistently overdosed, which seems like a minor, maybe even academic problem, until now when a decision has to be made about an antibody like pemivibart. We look at the activity conferred pemivibart and see it as well in an antiviral range validated by RCT as having an attractive treatment effect. Slide 28 is the FDA language describing the residual clinical uncertainty of what pemivibart dose may be optimal for those severely immune-compromised patients who are fighting an active infection without adequate immunologic response. On slide 29, we simply note on this point, there is a peculiar and deeply unfortunate consequence to the FDA's perspective for patients in such clear need. Slide 30 relates to the fact that indeed comparative antibodies are different and may have subtle differences in mechanism of action, and those differences may be difficult to measure but weigh on regulatory consideration. Slide 31, next, notes our view that indeed other than neutralization activity, we assessed and found a vector function essentially identical between pemivibart and adintrevimab, which should not be a surprise given the identical backbones. As for antibody non-neutralization, non-effector activities that are undescribed and unmeasured by both industry and FDA, those are a little hard for us to assess and respond to. We would humbly submit that these ambiguities are ever present in medicines new and old and indeed, we would welcome guidance on what unknown and undescribed thing we might measure going forward. So slide 32, where are we? Well, we have a new leadership team at the FDA, a changing agency, and as described, changing priorities at FDA and HHS. We intend to continue engagement with FDA both on pemivibart, which is here today, and on our new molecule, VYD2311, which we have accelerated rapidly through early clinical development. As a final point on the matter, slide 33 depicts the result of a similar analysis for bridging to treatment. For VYD2311, using arithmetic from currently circulating variants. You can see on the Y-axis that both proposed doses of VYD2311 provide sVNA tighter well in excess to that adintrevimab and indeed can either approach from below or well exceed the titers delivered by Regen-Cov, which sat toward the top of the old antibody leaderboard if you're keeping score at home. With data like these for VYD2311, we see the majority of the agency's pemivibart concerns well addressed. We hope that this comparison and recitation of the pemivibart treatment declination logic answers outstanding questions in the field. We will be working up a manuscript to describe the situation for a scientific journal in the next weeks. In the biggest picture, we're thrilled with the medical potential we see in our medicines. We appreciate the FDA's alignment with our desire for greater public transparency, and we look forward to re-engaging with the new FDA to discuss pemivibart, VYD2311, and this field of medicine generally. Needless to say, it is our overarching goal as a company to bring important high-value medicines to patients in need as rapidly as possible. I'll now turn the call over to Bill Duke to talk about the financials before we move to Q&A. Bill? William Duke Thank you, Marc. Turning to slide 35, prior to today's call, we released our Q1 2025 results, including PEMGARDA net product revenue of $11.3 million in March, ending cash and cash equivalent of approximately $48 million. As previously mentioned, to drive long-term top line growth, we made a strategic decision to internalize our sales force at the beginning of 2025. Although the shifts created a short-term headwind reflected in PEMGARDA products revenue during Q1, we are now seeing positive momentum with the return to growth and early signs of acceleration in Q2. We are pleased with the continued execution of financial discipline, reporting a continued reduction of operating expenses. We reported $27.4 million in operating expenses in Q1 2025 compared to $32.3 million in Q4 2024, a 15% reduction of quarter over quarter. This was after a decrease from Q3 to Q4 of over 50%. We anticipate operating expenses will continue to decrease in the second quarter as we have manufactured sufficient supply of PEMGARDA and VYD2311 and do not plan for significant further manufacturing expense in the near term. Backed by a strong cash position and potential to access up to $30 million in non-diluted funding through our term loan facility with SVB secured in April, we remain focused on growing PEMGARDA topline revenue, continued financial discipline and continue to target profitability by the end of the first half of 2025. I'll now turn the call over to the operator to open the call for questions. Operator Thank you. (Operator Instructions) Michael Yee, Jeffreys. Kyle Yang Hey, good morning, guys. Thanks for taking our questions. This is Kyle Yang from Michael. Just a few from us. The first one is, could you please characterize your recent interaction and/or experience with the new agency, particularly on EUA, including maintaining your EUA for COVID prevention and use of EUA for future applications including for treatment and also use of surrogate endpoints such as virus titers for approval? The second one real quick is on Q1 sales. Could you please cha characterize your -- the headwinds that you encountered in Q1. I understand you -- team briefly discussed it. Could you please expand on that and tell us how you addressed these areas of improvements in the second quarter and just help us think about your sales in Q2 and how do you -- and your confidence -- why -- what gives you confidence that you're going to see the momentum continue in the second quarter? Thank you. Marc Elia Great, thanks so much. Let me start and then I'll ask Tim to answer the second part. So regarding EUA, you asked a couple of different things but with respect to maintenance of the EUA, it is actually our preference to move with the FDA beyond that construct. Indeed, it's generally understood that EUAs are designed to effectively convert at some pace and subject to some mechanism. We've not actually had that conversation with the new FDA, which, as you may or may not know, is effectively recently seeded, but we're looking forward to it very much. Critically, our current EUA for the prevention of COVID-19 in certain immunocompromised persons, yeah, was generated on the basis of immuno bridging, but of course carries with it the results of a randomized clinical study interrogating both safety and exploratory clinical efficacy. So in our minds, those data are unique in the field. This is the point we've raised in a few different domains, particularly our recent Citizen Petition. So, unlike any other company we're aware of that has an authorized preventative or approved preventative, we actually have contemporary efficacy data. And so would seek to leverage that in one form or another, subject to discussion with the FDA of moving towards BLA. That would be our preference, and it would certainly be our preference going forward. So I don't think any of that is either of -- nerve-wracking nor surprising, it's in fact embedded into the very nature of a grant to the EUA and we're really looking forward to talking with them about that. On a go-forward basis, I think what we see is a pretty clear scientific, and I mean, sort of academic and clinical understanding that sVNA titers are a highly useful validated surrogate endpoint. And you can see that embedded into, of course, the work that we've done with FDA to date. And in fact, the evolution of our product fact sheet, which alludes to some of the meta-analytics describing these relationships. So we see the endemic virus situation as an opportunity to normalize all of this away from EUA into a landscape akin to an accelerated approval with the postmarket conversion study, which I think not coincidentally perhaps, appears to be the direction of travel for COVID-19 vaccines. All of that is to us highly welcome and embedded into all of our plans for both pemivibart and our molecules going forward. You have to remember that an EUA does not carry an express obligation to generate randomized clinical data on the other side of it. But of course, acceleratedated approvals do. So we would look forward to that paradigm and it's going to be a major feature of what we believe will be our upcoming discussions with the agency. So I hope that's clear. If it's not, please get back into the queue. But meanwhile, I'll ask Tim to expand on our Q1 changes and our confidence going forward. Tim Lee Yeah, of course. Thank you, Marc. I think we - I brushed over it pretty quickly, but when I looked back at what we were able to do in Q1, it was pretty remarkable. We decoupled from the contract sales organization and built our own best in class sales team, trained them and deployed them by partnering with our human resource team to make all this happen in weeks. And so we did see a disruption in field activity. But with that, we were really thoughtful on how we made that approach and amplified some of our -- some of the air cover that we can do with digital marketing, and others to fill a little bit of that void. I think what we're pleased with seeing right now, and I shared it on the key launch metrics slide is that when you look from January 1 through the end of April 30, we're seeing a really nice increase in breadth, depth, as well as unique accounts that the team is calling on. So we've really refocused around what we're calling, a core for specialists, including rheumatology, where we've seen a high degree of acceptance and adoption. And it's been a really good area of focus for us. I also look at where PEMGARDA is available. When I had my first call about a year ago with you, we had about 120 sites. Right now, if you go to our Infusion Finder, we have over 880 sites. So we continue to drive access to PEMGARDA really broadly through multiple channels and are starting to see that. Aand as I alluded to, we're seeing some really strong numbers into Q1 right now and are excited about that. Thanks so much. Operator Patrick Trucchio, HC Wainwright. (Operator Instructions) Hi, good morning. I'm sorry I was on mute. This is Luis in for Patrick. Thank you for taking our questions. And again, we understand that there are -- these are challenging times which we appreciate all of the team's work and progress so far. So on a follow-up question a little bit to what we discussed earlier, can you discuss a little bit more in detail the measles program, if you plan to pivot (technical difficulty) measles and if you -- what -- every details you can share on the expected clinical trial development path and potential market size and how -- and in the context of your current cash position and the non-diluted loan facility, how you're planning to prioritize? Marc Elia Thank you. Yeah, let me start. This is Marc and I'll see maybe Robbie can add some color. But when we're discussing our discovery programs, that is spending that is essentially in all of our standing budgets and it doesn't represent a particularly incremental draw from our forecasted cash balances. It is a matter of priority. So yeah, we're adding a program, for example, in measles, but I want to say you might have used the word pivot, which is not something that I would agree with. We're not pivoting any more than when we leave English class and go to math class, we're pivoting and deciding to just focus on math. We're adding something that we think could be potentially important and that could create a lot of value for patients in need and shareholders over time. So doing these early discovery programs provides us with a basis for considering clinical development under the right circumstances and again, as stewards of capital, we are always going to try to be disciplined about spending shareholder money only on those projects that we see having a very, very attractive near-term return profile. Now, in the case of measles, there may well be some interest in the -- at the -- even the national level, and we will look forward to exploring that potential. But I don't think you can consider any of it as a change or a particular draw on our capabilities or interests elsewhere, it is all about adding optionality and setting into place the ability to grow over the long term both in terms of our -- the scale of our business, but more importantly, growing the scale of our anticipated medical impact. Is that clear? Yeah, that's helpful. Operator Thank you. I would now like to turn the conference back over to the company for any closing remarks. Marc Elia Okay. Well, thank you very much all for joining us this morning and we will look forward to any further questions in a follow up later today. Thanks all. Bye-bye. Operator This concludes today's conference call. Thank you for participating. You may now disconnect. 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
Daily Mail
14-05-2025
- Automotive
- Daily Mail
Fox FM radio star shares serious warning as he's left with spinal injuries after being thrown from his motorcycle in horrific car collision: 'Would've saved me a lot of heartache'
Fox FM's Tim Lee has been seriously injured after a motorbike accident saw him break his pelvis. The Workday presenter, who has been with the radio station since 2019, is recovering in hospital after he was involved in a collision with a car on Friday in South Melbourne. The radio personality took to Instagram to share pictures of his recovery while using a bit of comedy and sarcasm to lighten the mood. 'Brain injury, broken fingers, spinal fracture ... None of that happened after a Volkswagen ploughed into me making a turn at full speed without indicating as I was leaving work to enjoy seven days of annual leave!!' Lee joked. However, on a serious note, Tim revealed that the injury to his back was not a laughing matter and that he 'got off lightly'. 'The bruising isn't great, the helmet is cactus, but the broken pelvis is easily the worst part. 0 stars. 'In the scheme of things I got off lightly. Sh*t happens, will just make me even more careful when I get to swing a leg over in 3-4 months.' Tim then thanked his 'radio crew' and everyone who reached out to him following the accident, before warning others who are taking to the roads. 'Everyone; please use your indicators! Would've saved me a lot of heartache. 'It did mean I got to try fentanyl though, so swings and roundabouts...' he quipped. In one photo, Tim could be seen lying on a hospital gurney as he took a selfie in the light above. Other pictures showed the scene of the accident, where his motorcycle lay crumpled on the street in front of a Volkswagen, which had a large dent on the front. Another snap showed the radio presenter smiling in a neck brace as he was surrounded by family. While Lee recovers, he will be covered in the studio by Ellie Angel-Mobbs and Brad Wood. In March, Brendan Fevola shocked his Fox FM co-stars by revealing he would be stepping away from the program. The former AFL champ and radio star, 44, told listeners he would be competing on the upcoming season of Channel Ten's The Amazing Race and would be absent for some time. 'I'm leaving the show... not for good, though,' he began. 'I got an opportunity last year to do something with my 18-year-old daughter Leni - to travel the world on the TV show The Amazing Race! So, I won't be on the show as of Monday.' Co-host Fifi Box then wished Brendan all the best and asked if he had any idea when he would be returning. 'I could be away for a couple of days, a couple of weeks, depends on when I get eliminated... I am not worried about the race, I am worried about whether Leni and I punch on or not. That could be our elimination,' he joked. Brendan has co-hosted the top-rating Fox Melbourne breakfast show since April 2016. When he joined it was known as Fifi, Dave and Fev and he hosted alongside Fifi Box and Dave Thornton. Thornton resigned in 2017 and the show's current line-up of Brendan, Fifi and Nick Cody has been in place since 2021.
National Post
05-05-2025
- Health
- National Post
Prollenium Adds RENEW™+ Skin Booster to the REVANESSE® Collection
Article content The product marks a new era for dermal injections with long-lasting hydration to improve skin quality from the inside out. Article content Article content RICHMOND HILL, Ontario — Prollenium, a global leader in medical aesthetic technology, launches Renew™+ to the Revanesse ® family of dermal fillers in Canada. Available immediately, Revanesse® Renew™+ is a unique skin booster that combines low and high molecular weight hyaluronic acid (HA) to hydrate and rejuvenate the skin below the surface, improving skin texture and creating a smoother, more radiant appearance. Article content Unlike traditional fillers, Revanesse® Renew™+ is a skin-boosting injection made with 100% high-purity, non-cross-linked HA with a low viscosity and easy spreadability. It is ideal for improving skin quality. Injected into the top layers of skin on the face, neck, or chest, it attracts and retains water molecules, adding an extra moisture boost for a refreshed and renewed look. Article content 'Renew™+ is a first-of-its-kind dermal filler made in Canada and continues the tradition of breakthrough innovations for the family of Revanesse® products,' said Tim Lee, Chief Scientific Officer of Prollenium. Revanesse® Renew™+ marks the next generation of dermal injections, using the latest technology and advancements to create a lasting solution that leaves patients glowing and rejuvenated. Article content The Revanesse® family of dermal fillers features multi-purpose HA-based dermal fillers that provide real results instantly with a quick, minimally invasive beauty treatment. Revanesse® Renew+™ penetrates deeply to hydrate from within, reducing the appearance of fine lines and wrinkles for smoother, plumper skin. Works on the skin's surface to firm, tone, and lock in moisture for a more lifted, youthful look. Article content 'At Prollenium, we're committed to creating top-of-the-line products to help health care providers give patients the refreshed look they've always wanted,' said Walter Geiger, acting CEO of Prollenium. 'This latest product in the Revanesse® line underscores our dedication to equipping providers with the latest technology and advancements in the medical aesthetics industry.' Article content Revanesse® Renew™+ is administered via microinjections into the superficial dermis using fine gauge needles, spaced evenly, 1 cm apart across the desired treatment area. For optimal results, it is recommended to have 2 treatments at 4 weeks apart. Article content About Prollenium Prollenium leads the way in facial aesthetics and rejuvenation technology, turning complex science into reliable, effective products. As the first FDA-approved dermal filler manufacturer in North America, Prollenium redefines standards with cutting-edge innovation, exceptional safety, and a portfolio tailored to patient needs. Article content Article content Article content Article content Article content Article content
