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3 days ago
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Vera Therapeutics Announces Refinancing of Existing Oxford Debt Facility, Providing up to $500 Million of Term Loans
BRISBANE, Calif., June 03, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. ('Vera'), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that it has entered into a new credit facility providing for up to $500 million of term loans with its current partner Oxford Finance LLC ('Oxford'). The new credit facility will replace Vera's existing $50 million credit facility. The initial funding of the new credit facility will be in a principal amount of $75 million and is expected to occur on June 4, 2025. Highlights of the new credit facility include: Lowered Interest Rate: Reduced borrowing cost by 320 basis points based on current interest rates. The facility will mature five years from the closing date. Interest will be paid monthly at a rate per annum equal to 1-month SOFR plus 4.95%, subject to a SOFR floor of 3.75%. Increased Capital Availability: Added $450 million of discretionary incremental capacity available in five tranches. At its discretion, Vera may draw up to $50 million from January 1, 2026 through December 31, 2026, not subject to additional performance milestones. Vera has the option to draw $75 million upon accelerated approval of atacicept in immunoglobulin A nephropathy (IgAN), two $50 million tranches post accelerated approval and subject to commercial milestones, and up to $200 million at the mutual discretion of Vera and Oxford. Improved Structure & Financial Flexibility: Extended the interest only period by up to 42 months and maturity by up to 41 months. As a result of this refinancing, Vera will no longer be required to make principal payments in 2026. The new facility also reduced prepayment and final-payment fees and, combined with the reduced interest rate, results in a cost-effective refinancing that significantly lowers Vera's cost of capital. 'We have crossed a significant Vera milestone with the primary endpoint results from the pivotal atacicept ORIGIN 3 trial; and given the data we presented earlier, we expect this to enable a BLA submission to the FDA in the fourth quarter of this year, which may allow for approval and commercial launch in 2026. If approved, we believe that atacicept has the potential to advance the standard of care in IgA nephropathy,' said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. 'The Vera team is well-positioned to build on the success of the lead atacicept development program in IgAN, with the expansion into additional potential indications in other autoimmune kidney diseases and beyond.' The refinancing significantly reduces interest expense and improves financial flexibility and access to capital as compared to the existing credit facility, with the new credit facility having more borrower-favorable terms overall than those under the existing credit facility. The refinancing enhances Vera's ability to generate cash and manage its capital structure efficiently while providing additional working capital flexibility to support commercial launch and strategic initiatives. 'Our partnership with Oxford over the past three years has been key to supporting Vera's growth and we are happy to continue this incredibly productive relationship,' said Sean Grant, Chief Financial Officer of Vera. 'We are also very pleased to be able to execute this non-dilutive transaction in today's market environment with Oxford. Through a competitive process, we secured favorable terms with our current lender, eliminated exit fees from the existing credit facility, and closed the refinancing in a very efficient manner.'A Form 8-K outlining the full terms of the new credit facility will be filed with the Securities and Exchange Commission. Armentum Partners acted as exclusive financial advisor to Vera. Latham and Watkins LLP served as legal advisor to Vera, and Manatt, Phelps and Phillip, LLP served as legal advisor to Oxford. About VeraVera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera's expectations regarding the credit facility and its impact on Vera's business and financial position, Vera's plans to submit a BLA to the FDA and receive FDA approval for atacicept in IgAN and launch it commercially, and, in each case, the timing thereof, atacicept's potential as a treatment for indications beyond IgAN, atacicept's potential to advance the standard of care in IgAN, if approved, and other statements that are not historical fact. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'believe,' 'expect,' 'may,' 'plan,' 'potential,' 'will' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera's business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@ Media Contact:Debra CharlesworthVera Therapeutics415-854-8051corporatecommunications@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
4 days ago
- Business
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Vera drug scores in closely watched study in rare kidney disease
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. An experimental medicine from Vera Therapeutics succeeded in a late-stage trial in a rare kidney disease, positioning the company to discuss an approval application with U.S. regulators in the near future. According to Vera, the drug, called atacicept, met its main goal in a Phase 3 trial in IgA nephropathy, a chronic condition that can lead to kidney failure. After 36 weeks of treatment, atacicept was associated with a 42% reduction versus a placebo — and a 46% decline from the study's start — in the amount of protein in participants' urine, an important marker of kidney health. Without providing specifics, Vera said atacicept's other efficacy results were 'consistent with or better than' what was observed in mid-stage testing and had a safety profile 'comparable to placebo.' The company will share the data with the Food and Drug Administration in the coming weeks and intends to file an accelerated approval request in the fourth quarter. Vera is one of the leaders in a push to develop new treatments for IgA nephropathy, or IgAN, a progressive disease that damages the kidneys. Some estimates hold 130,000 to 150,000 people in the U.S. have IgAN. While several medicines are approved, they don't totally stop patients' kidney function from deteriorating. That need, and a better understanding of the disease's biology, has led to an uptick in dealmaking involving IgAN. Drugs recently launched by Travere Therapeutics and Calliditas Therapeutics have performed well, too. Vera's atacicept is part of a newer wave of therapies aimed at immune-mediated drivers of the disease. Like several others in development, it targets a pair of cytokines called BAFF and April that stimulate production of the 'autoantibodies' that mistakenly target the body's own tissue. In Phase 2 testing, the drug stabilized a key marker of disease progression so well that some analysts viewed the findings as the bar for other competitors to meet. The findings also heightened anticipation for Vera's Phase 3 study. According to Marshall Fordyce, Vera's founder and CEO, the drug's effects on urine protein in the trial significantly 'exceed the bar' for what U.S. regulators have accepted in granting an accelerated approval to several other medications. The figure Vera reported also represents the 'deepest reduction' in a late-stage stage study in IgAN patients to date, he wrote in an email. Investors appear to agree, as Vera's shares climbed by nearly 60%, to over $30 apiece, in early trading on Monday. Vera has competition ahead, as Otsuka Pharmaceutical could win approval of a similar type of medicine by late November. The company will present detailed Phase 3 study results at a medical meeting on Friday and, though cross-trial comparisons come with caveats, analysts and investors will be paying close attention to how the two treatments stack up. Vera, for its part, believes the market for IgAN treatments is 'ripe for disruption,' according to Fordyce. There are currently 'low levels of approved product saturation,' Fordyce wrote, and newer drugs like atacicept 'may represent a differentiated approach.' The company is also studying the drug in people whose are at 'moderate' or 'low' risk of disease progression, which, if successful, could boost its sales potential. The Phase 3 trial, meanwhile, will continue on while Vera accumulates data on atacicept's impact on kidney function. Those findings are expected in 2027. Vera's results have implications for drugmakers like Biogen and Vertex Pharmaceuticals, which have both cut deals for companies developing IgAN drugs. Vertex has said it could file for approval of a drug that also targets BAFF and April early next year, if data are supportive.
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4 days ago
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Vera Therapeutics Announces Atacicept Achieved 46% Proteinuria Reduction in ORIGIN Phase 3 Trial in Adults with IgA Nephropathy
Atacicept ORIGIN Phase 3 trial met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001) Other prespecified endpoints achieved similar or better results compared to the ORIGIN Phase 2b clinical trial — per FDA guidance, Vera is not sharing eGFR results at this time while the ORIGIN 3 placebo-controlled trial continues The safety profile of atacicept was favorable, and comparable to placebo Vera plans to meet with FDA in the coming weeks to discuss these results and the regulatory pathway; Vera currently plans to submit a Biologics License Application (BLA) for accelerated approval to the FDA in 4Q 2025; ORIGIN 3 trial continues with two-year results expected in 2027 Vera will host a conference call and webcast at 8:00 am ET on Monday, June 2 BRISBANE, Calif., June 02, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that the primary endpoint was met in the ORIGIN Phase 3 trial of atacicept for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) at week 36. For other prespecified endpoints, atacicept treatment also demonstrated results that were consistent with or better than those previously observed in the ORIGIN Phase 2b trial.1 The safety profile of atacicept in this analysis was favorable, and comparable to placebo. Vera plans to share these results with the FDA in the coming weeks, and full results will be submitted to the American Society of Nephrology Kidney Week. 'ORIGIN 3 is the first Phase 3 clinical trial in IgAN to demonstrate this magnitude of UPCR reduction compared to placebo at week 36. These results convincingly demonstrate the impact of atacicept to reduce proteinuria,' said Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Glomerular Disease Center at Stanford University Medical Center, and a primary investigator for both ORIGIN 2b and ORIGIN 3. 'If approved, we believe that atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor. We currently plan to submit a BLA for atacicept in IgAN to the FDA in the fourth quarter of this year, which may allow for US approval and commercial launch in 2026. We are grateful to the study participants, their families and caregivers, the study investigators and staff, our research partners, and the Vera team for their ongoing commitment and dedication to this important research,' said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. 'Vera aspires to evolve the practice of kidney medicine with the hope that, one day, patients may no longer face a future of dialysis or transplantation. Vera is poised for potential commercial launch of atacicept in 2026 and to pursue development in additional indications in other autoimmune kidney diseases and beyond.' 'Patients with IgA nephropathy, as well as their families and care partners, suffer from clinical uncertainty and the horrible outcome of kidney failure. In addition to clinical signs and symptoms, IgAN has a devastating impact on quality of life and mental wellbeing. I'm thrilled with the progress that is being made in developing new treatments for patients,' said Bonnie Schneider, Director and Cofounder of the IgA Nephropathy Foundation. ORIGIN 3 is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 431 adults with IgA nephropathy. Participants were randomized 1:1 to atacicept 150 mg, self-administered at home via once weekly subcutaneous injection, or placebo. The primary efficacy endpoint was the change in 24-hour UPCR compared to placebo at the 36-week interim analysis. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR and is expected to complete in 2027. For more information about the ORIGIN 3 clinical trial (NCT04716231), please visit The Company will host an investor call and webcast to discuss the data update at 8:00 AM ET on Monday, June 2. Investors Dial-in: 1-877-425-9470 Int'l Investors Dial-in: 1-201-389-0878 Conference ID: 13754147 Webcast: The live webcast will be available on the Company's Investor Calendar, with the recording and presentation available immediately following the event. References1. Barratt J, et al. JASN 2024 About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN, other autoimmune kidney diseases and lupus nephritis. The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA's determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different indications. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, atacicept's potential to be a best-in-class therapy for patients with IgAN, atacicept's potential as a treatment for indications beyond IgAN, Vera's expectations concerning other predefined endpoints in the Phase 3 ORIGIN trial, as well as the two-year data therefrom, Vera's plans to meet with, and submit a BLA for atacicept to, the FDA, and to potentially receive FDA approval for atacicept in IgAN and launch it commercially, and, in each case, the timing thereof, the potential for atacicept to bring value for patients and to the change the standard of care in IgAN, if approved, and other statements that are not historical fact. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'anticipate,' 'believe,' 'expect,' 'plan,' 'potential' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary or interim results may not be predictive of final study results, risks and uncertainties associated with Vera's business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@ Media Contact:Debra CharlesworthVera Therapeutics415-854-8051corporatecommunications@ 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
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4 days ago
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Vera Therapeutics Announces Atacicept Achieved 46% Proteinuria Reduction in ORIGIN Phase 3 Trial in Adults with IgA Nephropathy
Atacicept ORIGIN Phase 3 trial met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001) Other prespecified endpoints achieved similar or better results compared to the ORIGIN Phase 2b clinical trial — per FDA guidance, Vera is not sharing eGFR results at this time while the ORIGIN 3 placebo-controlled trial continues The safety profile of atacicept was favorable, and comparable to placebo Vera plans to meet with FDA in the coming weeks to discuss these results and the regulatory pathway; Vera currently plans to submit a Biologics License Application (BLA) for accelerated approval to the FDA in 4Q 2025; ORIGIN 3 trial continues with two-year results expected in 2027 Vera will host a conference call and webcast at 8:00 am ET on Monday, June 2 BRISBANE, Calif., June 02, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that the primary endpoint was met in the ORIGIN Phase 3 trial of atacicept for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) at week 36. For other prespecified endpoints, atacicept treatment also demonstrated results that were consistent with or better than those previously observed in the ORIGIN Phase 2b trial.1 The safety profile of atacicept in this analysis was favorable, and comparable to placebo. Vera plans to share these results with the FDA in the coming weeks, and full results will be submitted to the American Society of Nephrology Kidney Week. 'ORIGIN 3 is the first Phase 3 clinical trial in IgAN to demonstrate this magnitude of UPCR reduction compared to placebo at week 36. These results convincingly demonstrate the impact of atacicept to reduce proteinuria,' said Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Glomerular Disease Center at Stanford University Medical Center, and a primary investigator for both ORIGIN 2b and ORIGIN 3. 'If approved, we believe that atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor. We currently plan to submit a BLA for atacicept in IgAN to the FDA in the fourth quarter of this year, which may allow for US approval and commercial launch in 2026. We are grateful to the study participants, their families and caregivers, the study investigators and staff, our research partners, and the Vera team for their ongoing commitment and dedication to this important research,' said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. 'Vera aspires to evolve the practice of kidney medicine with the hope that, one day, patients may no longer face a future of dialysis or transplantation. Vera is poised for potential commercial launch of atacicept in 2026 and to pursue development in additional indications in other autoimmune kidney diseases and beyond.' 'Patients with IgA nephropathy, as well as their families and care partners, suffer from clinical uncertainty and the horrible outcome of kidney failure. In addition to clinical signs and symptoms, IgAN has a devastating impact on quality of life and mental wellbeing. I'm thrilled with the progress that is being made in developing new treatments for patients,' said Bonnie Schneider, Director and Cofounder of the IgA Nephropathy Foundation. ORIGIN 3 is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 431 adults with IgA nephropathy. Participants were randomized 1:1 to atacicept 150 mg, self-administered at home via once weekly subcutaneous injection, or placebo. The primary efficacy endpoint was the change in 24-hour UPCR compared to placebo at the 36-week interim analysis. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR and is expected to complete in 2027. For more information about the ORIGIN 3 clinical trial (NCT04716231), please visit The Company will host an investor call and webcast to discuss the data update at 8:00 AM ET on Monday, June 2. Investors Dial-in: 1-877-425-9470 Int'l Investors Dial-in: 1-201-389-0878 Conference ID: 13754147 Webcast: The live webcast will be available on the Company's Investor Calendar, with the recording and presentation available immediately following the event. References1. Barratt J, et al. JASN 2024 About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN, other autoimmune kidney diseases and lupus nephritis. The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA's determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different indications. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, atacicept's potential to be a best-in-class therapy for patients with IgAN, atacicept's potential as a treatment for indications beyond IgAN, Vera's expectations concerning other predefined endpoints in the Phase 3 ORIGIN trial, as well as the two-year data therefrom, Vera's plans to meet with, and submit a BLA for atacicept to, the FDA, and to potentially receive FDA approval for atacicept in IgAN and launch it commercially, and, in each case, the timing thereof, the potential for atacicept to bring value for patients and to the change the standard of care in IgAN, if approved, and other statements that are not historical fact. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'anticipate,' 'believe,' 'expect,' 'plan,' 'potential' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary or interim results may not be predictive of final study results, risks and uncertainties associated with Vera's business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@ Media Contact:Debra CharlesworthVera Therapeutics415-854-8051corporatecommunications@ 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
Associated Press
26-02-2025
- Business
- Associated Press
Vera Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results
On track to announce the primary endpoint result from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025; BLA submission to the U.S. FDA for accelerated approval planned in 2H 2025 Expanded atacicept clinical development program in multiple autoimmune kidney diseases proceeding in 2025 Strengthened balance sheet to support clinical pipeline development, planned FDA submission, and potential 2026 commercial launch of atacicept for the treatment of IgAN BRISBANE, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the fourth quarter and full year ended December 31, 2024. 'Vera is poised to change the standard of care in autoimmune diseases with atacicept, our investigational therapy, beginning with IgA nephropathy. We are on track to announce the primary endpoint result of the ORIGIN Phase 3 study in the second quarter of this year. We look forward to submitting a Biologics License Application (BLA) for this potential best-in-class therapy in the second half of this year. We are grateful to the study investigators and participants for their ongoing and enthusiastic participation in this program,' said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. 'In addition, over the past year we have made progress advancing our broader development pipeline, including additional potential indications for atacicept.' Fiscal 2024 and Recent Business Highlights Received FDA Breakthrough Therapy Designation for atacicept in IgAN Presented positive data showing eGFR stabilization over 96 weeks in the ORIGIN Phase 2b clinical trial of atacicept in IgAN in a late-breaking oral presentation at the American Society of Nephrology Kidney Week 2024, and in a simultaneous peer-reviewed publication in the Journal of the American Society of Nephrology Initiated the ORIGIN Extend study, providing ORIGIN 2b/3 participants with extended access to atacicept and capturing longer-term safety and efficacy data Announced an expanded development pipeline for atacicept across multiple autoimmune kidney diseases, including primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) beginning in 2025 Acquired exclusive rights for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases Completed two equity financings in 2024, for a total of approximately $593.2 million in net proceeds, further bolstering the balance sheet ahead of potential regulatory submission and commercial launch Appointed multiple industry veterans to the leadership team, including Robert Brenner, M.D., as Chief Medical Officer, William Turner as Chief Regulatory Officer, David Johnson as Chief Operating Officer, and Jason Carter as Chief Legal Officer, throughout 2024 Major Upcoming Milestones Planned updates from the ongoing pivotal ORIGIN 3 trial: Anticipate full enrollment in 2Q 2025 On track to announce the primary endpoint result in 2Q 2025 Plan to submit a BLA to the U.S. FDA in 2H 2025 for atacicept in IgAN for accelerated approval assuming supportive data; and would expect a PDUFA date and commercial launch in 2026 QM dose finding study initiating in 2025 to evaluate extended dosing Plan to initiate the PIONEER trial in 2025, which would evaluate atacicept in expanded IgAN populations and anti-PLA2R positive PMN and anti-nephrin positive FSGS and MCD Financial Results for the Quarter and Year Ended December 31, 2024 For the year ended December 31, 2024, the company reported a net loss of $152.1 million, or a net loss per diluted share of $2.75, compared to a net loss of $96.0 million, or a net loss per diluted share of $2.25, for the year ended December 31, 2023. During the year ended December 31, 2024, net cash used in operating activities was $134.7 million, compared to $92.2 million for the same period last year. Vera reported $640.9 million in cash, cash equivalents, and marketable securities as of December 31, 2024, which the company believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA's determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications. About Vera Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger's disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. For more information, please visit Forward-looking Statements Statements contained in this press release regarding matters, events or results that may occur in the future are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera's plans to complete enrollment and to receive and report primary endpoint result in the Phase 3 ORIGIN 3 trial, to submit a Biologics License Application to the FDA, and to potentially receive a PDUFA date, receive FDA approval for atacicept in IgAN and launch it commercially, and Vera's ability to fund its operations through potential approval and U.S. commercial launch of atacicept. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'believe,' 'plan,' 'potential' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera's business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact: Joyce Allaire LifeSci Advisors 212-915-2569 Media Contact: Madelin Hawtin LifeSci Communications [email protected] VERA THERAPEUTICS, INC. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (Unaudited) For the Year Ended December 31, 2024 2023 Operating expenses: Research and development $ 126,172 $ 78,225 General and administrative 40,998 23,787 Total operating expenses 167,170 102,012 Loss from operations (167,170) (102,012) Other income, net 15,022 6,023 Provision for income taxes (1) (1) Net loss $ (152,149) $ (95,990) Change in unrealized gain/loss on marketable securities 142 251 Comprehensive loss $ (152,007) $ (95,739) Net loss per share attributable to common stockholders, basic and diluted $ (2.75) $ (2.25) Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 55,326,680 42,707,072 VERA THERAPEUTICS, INC. Condensed Balance Sheets (in thousands) (Unaudited) December 31, 2024 2023 Assets Current assets: Cash, cash equivalents and marketable securities $ 640,852 $ 160,716 Prepaid expenses and other current assets 10,366 11,307 Total current assets 651,218 172,023 Operating lease right-of-use assets 3,372 2,949 Other noncurrent assets 1,091 574 Total assets $ 655,681 $ 175,546 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 7,665 $ 11,118 Operating lease liabilities 1,483 2,436 Accrued expenses and other liabilities, current 16,223 8,749 Total current liabilities 25,371 22,303 Long-term debt 50,687 49,877 Operating lease liabilities, noncurrent 2,468 1,395 Accrued expenses and other liabilities, noncurrent - 286 Total liabilities 78,526 73,861 Stockholders' equity Common stock 64 44 Additional paid-in-capital 1,037,948 410,492 Accumulated other comprehensive income 393 251 Accumulated deficit (461,250) (309,102) Total stockholders' equity 577,155 101,685 Total liabilities and stockholders' equity $ 655,681 $ 175,546
