Vera Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results
- Positive 72-week data from Phase 2b ORIGIN trial for IgAN
- Actively enrolling pivotal Phase 3 ORIGIN 3 study for atacicept
- Completed $287.5 million financing to strengthen balance sheet
- Appointed industry veterans to key positions
- Net loss of $96.0 million for year ended December 31, 2023
- Net cash used in operating activities was $92.2 million for 2023
- $160.7 million in cash, cash equivalents, and marketable securities as of December 31, 2023
- None.
Insights
The recently announced 72-week data from the Phase 2b ORIGIN clinical trial by Vera Therapeutics indicates a significant milestone in the development of atacicept for IgA Nephropathy (IgAN). The stability of eGFR over the treatment duration suggests a potential for disease modification, which could differentiate atacicept from existing treatments. From a financial perspective, the completion of a $287.5 million financing strengthens the company's balance sheet and extends its cash runway, which is critical for supporting ongoing clinical trials and preparing for a potential commercial launch.
However, investors should consider the inherent risks of biotech investments, where positive clinical trial results do not always translate into commercial success. The market for IgAN treatments is still emerging and the adoption of new therapies will depend on factors such as efficacy, safety, cost and reimbursement policies. The anticipation of topline data from the Phase 3 ORIGIN trial in the first half of 2025 will be a key driver of the company's valuation in the short to medium term, with significant implications for the stock's performance.
The positive outcomes reported for atacicept in the Phase 2b trial, such as reductions in Gd-IgA1, hematuria, proteinuria and stable eGFR, are encouraging for the IgAN patient community. These results suggest that atacicept could offer a new mechanism of action for treating IgAN, potentially improving the standard of care. For stakeholders, such as healthcare providers and payers, the emphasis will be on the clinical significance of these results and their translation into real-world benefits.
It's also important to note that while the data is promising, the true test will come with the results of the Phase 3 ORIGIN trial. The trial's success could lead to FDA approval and the company's proactive site addition and enrollment activities indicate a strategic push towards achieving this goal. The long-term impact on patients will depend on the drug's efficacy, safety profile and accessibility post-approval.
Given the competitive landscape of the biotechnology sector, Vera Therapeutics' progress in the clinical development of atacicept positions the company favorably within the niche market of IgAN treatments. The disease-modifying potential of atacicept could capture significant market share if approved. The strategic appointments of industry veterans in key positions also signal the company's intent to bolster its commercialization capabilities.
Market dynamics, such as the prevalence of IgAN, the current treatment paradigm and the potential market size, will be important in assessing the long-term commercial prospects of atacicept. The company's financial strategy, demonstrated by the recent capital raise, positions it to navigate the costly Phase 3 trial and subsequent commercialization phase, which are critical steps before realizing any revenue from the product. Investors should monitor the enrollment progress and eventual trial outcomes as they will heavily influence the company's financial health and market potential.
- Presented positive 72-week data from the Phase 2b ORIGIN clinical trial, setting a new standard in IgAN with no loss of kidney function over the duration of treatment
- Actively adding sites and enrolling pivotal Phase 3 ORIGIN 3 study of atacicept for the treatment of IgAN; topline data expected in 1H 2025
- Completed
$287.5 million financing, further strengthening the Company’s balance sheet and extending the Company’s expected cash runway through potential approval and commercial launch
BRISBANE, Calif., March 20, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunologic diseases, today reported its business highlights and financial results for the fourth quarter and year ended December 31, 2023.
“Over the past year, we have strengthened the integrated data package for atacicept as a potentially disease-modifying treatment for patients with IgA Nephropathy (IgAN) and rapidly advanced the pivotal Phase 3 ORIGIN 3 clinical trial, which is expected to support our BLA submission to the FDA next year,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We believe atacicept 72-week data from the Phase 2b ORIGIN trial are consistent with a profile of true disease modification. Our clinical successes to date, including the announcement of multiple positive data readouts from the Phase 2b ORIGIN trial of atacicept in patients with IgAN, as well as executing on the ORIGIN 3 study, have gained broad attention across the clinical landscape, and we have attracted several respected industry veterans to expand our team in support of our advancing pipeline.”
“The 72-week data we recently announced from the ORIGIN 2b study supports our belief that atacicept has the potential to provide IgAN patients with long-term disease modification, evidenced by deep reductions in pathogenic Gd-IgA1, hematuria, proteinuria and most importantly, with stable eGFR. In aggregate, this quartet of findings provides support for our previous hypothesis that atacicept has the potential to be a transformative advancement for IgAN patients and may become the cornerstone treatment for this disease. The ORIGIN 2b results also provide us with even greater confidence in the ongoing ORIGIN Phase 3 trial, which continues to be on track with regard to enrollment,” stated Robert Brenner, M.D., Chief Medical Officer of Vera Therapeutics.
Key Fiscal Year 2023 and Recent Business Highlights
- Presented positive 72-week data from ORIGIN Phase 2b trial of atacicept in IgAN that show consistent and sustained reductions in Gd-IgA1, hematuria, and UPCR, with stable eGFR over the duration of treatment
- Actively adding sites and enrolling pivotal Phase 3 clinical trial (ORIGIN 3) of atacicept for the treatment of IgAN since initiating enrollment in June 2023
- Appointed industry veterans Robert M. Brenner, M.D., as Chief Medical Officer and William D. Turner as Chief Development Officer
- Completed
$287.5M upsized public offering of its Class A common stock in February 2024 that further strengthened the balance sheet
Upcoming Milestones
- Completion of Phase 3 full enrollment for primary endpoint estimated in the second half of 2024
- Present 96-week data from ORIGIN Ph 2b clinical trial of atacicept in IgAN in the fourth quarter
- Topline data from the pivotal ORIGIN 3 trial expected to be presented in the first half of 2025
Financial Results for the Quarter and Year Ended December 31, 2023
For the year ended December 31, 2023, the company reported a net loss of
During the year ended December 31, 2023, net cash used in operating activities was
Vera reported
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 immunologic 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 and plasma 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. For more information, please visit www.veratx.com.
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 endpoint and showed a statistically significant and sustained reduction in mean proteinuria versus baseline, as well as stabilized eGFR, at weeks 24, 36, and 72. Vera believes atacicept is positioned for best-in-class potential, targeting B cells and plasma cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications.
About MAU868
MAU868, a potential first-in-class monoclonal antibody, has the potential to neutralize infection by blocking BKV virions from binding to host cells. BKV is a polyoma virus that can be reactivated in settings of immunosuppression, such as in kidney transplant. It is a leading cause of kidney transplant loss and transplant-associated morbidity; there are currently no approved treatments for BKV. Vera holds an exclusive worldwide license from Amplyx Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., for the development and commercialization of MAU868 in all indications.
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, atacicept’s potential to be a transformational treatment for patients with IgAN and become a cornerstone treatment for IgAN, Vera’s plans to complete enrollment of its pivotal Phase 3 study in the second half of 2024, expectations regarding reporting 96-week data from the ORIGIN Phase 2b trial in 2024, Vera’s plans to receive and share topline data from the pivotal Phase 3 trial in the first half of 2025, Vera’s expectations to submit a BLA for atacicept for IgAN to the FDA in 2025, and Vera’s product candidates, strategy, and regulatory matters. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “potential,” “expect,” “plan,” 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
jallaire@lifesciadvisors.com
Media Contact:
Mari Purpura
LifeSci Advisors
mpurpura@lifesciadvisors.com
| VERA THERAPEUTICS, INC. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) | ||||||||
| For the Year Ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 78,225 | $ | 68,993 | ||||
| General and administrative | 23,787 | 21,910 | ||||||
| Total operating expenses | 102,012 | 90,903 | ||||||
| Loss from operations | (102,012 | ) | (90,903 | ) | ||||
| Other income, net | 6,023 | 1,848 | ||||||
| Provision for income taxes | (1 | ) | (1 | ) | ||||
| Net loss | $ | (95,990 | ) | $ | (89,056 | ) | ||
| Change in unrealized gain/loss on marketable securities | 251 | (224 | ) | |||||
| Comprehensive loss | $ | (95,739 | ) | $ | (89,280 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (2.25 | ) | $ | (3.35 | ) | ||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 42,707,072 | 26,570,676 | ||||||
| VERA THERAPEUTICS, INC. Condensed Balance Sheets (in thousands) | ||||||||
| December 31, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term marketable securities | $ | 160,716 | $ | 114,653 | ||||
| Prepaid expenses and other current assets | 11,307 | 11,045 | ||||||
| Total current assets | 172,023 | 125,698 | ||||||
| Operating lease right-of-use assets | 2,949 | 5,173 | ||||||
| Non-marketable equity securities | 11 | 58 | ||||||
| Other noncurrent assets | 563 | 506 | ||||||
| Total assets | $ | 175,546 | $ | 131,435 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 11,118 | $ | 11,991 | ||||
| Operating lease liabilities | 2,436 | 2,645 | ||||||
| Accrued expenses and other current liabilities | 8,749 | 10,964 | ||||||
| Total current liabilities | 22,303 | 25,600 | ||||||
| Long-term debt | 49,877 | 24,810 | ||||||
| Operating lease liabilities, noncurrent | 1,395 | 3,831 | ||||||
| Accrued and other noncurrent liabilities | 286 | 286 | ||||||
| Total liabilities | 73,861 | 54,527 | ||||||
| Stockholders' equity | ||||||||
| Common stock | 44 | 28 | ||||||
| Additional paid-in-capital | 410,492 | 290,216 | ||||||
| Accumulated other comprehensive gain/loss | 251 | (224 | ) | |||||
| Accumulated deficit | (309,102 | ) | (213,112 | ) | ||||
| Total stockholders' equity | 101,685 | 76,908 | ||||||
| Total liabilities and stockholders' equity | $ | 175,546 | $ | 131,435 | ||||
FAQ
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