Vera Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results
Vera Therapeutics, Inc. (VERA) presented positive 72-week data from the Phase 2b ORIGIN clinical trial for IgA Nephropathy (IgAN), showing no loss of kidney function. They are actively enrolling the pivotal Phase 3 ORIGIN 3 study for atacicept, expecting topline data in 1H 2025. The company completed a $287.5 million financing, strengthening their balance sheet and extending cash runway. Key fiscal year 2023 highlights include appointing industry veterans to key positions, presenting positive data from the ORIGIN trial, and advancing their pipeline.
Positive
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
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.
03/20/2024 - 07:30 AM
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 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 Completed $287.5M upsized public offering of its Class A common stock in February 2024 that further strengthened the balance sheetUpcoming 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 $96.0 million , or a net loss per diluted share of $2.25 , compared to a net loss of $89.1 million , or a net loss per diluted share of $3.35 , for the same period last year.
During the year ended December 31, 2023, net cash used in operating activities was $92.2 million , compared to $67.6 million for the same period last year.
Vera reported $160.7 million in cash, cash equivalents, and marketable securities as of December 31, 2023. Subsequent to December 31, 2023, the Company strengthened its balance sheet upon completing an upsized public offering of its Class A common stock with gross proceeds of approximately $287.5 million , before deducting underwriting discounts and commissions and offering expenses.
About Vera www.veratx.com
About Atacicept
About MAU868
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: jallaire@lifesciadvisors.com
Media Contact: 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 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 Weighted-average shares used in computing net loss per share attributable to
VERA THERAPEUTICS, INC. Condensed Balance Sheets (in thousands) December 31, December 31, 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
Vera Therapeutics presented positive 72-week data from the Phase 2b ORIGIN clinical trial for IgA Nephropathy, showing no loss of kidney function.
The ticker symbol for Vera Therapeutics is VERA.
Vera Therapeutics completed a $287.5 million financing to strengthen their balance sheet.
Robert M. Brenner, M.D., was appointed as the Chief Medical Officer of Vera Therapeutics.
Vera Therapeutics reported a net loss of $96.0 million for the year ended December 31, 2023.
