- 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
“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
“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
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 andWilliam D. Turner as Chief Development Officer - Completed
$287.5M upsized public offering of its Class A common stock inFebruary 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
For the year ended
During the year ended
Vera reported
About Vera
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
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
For more information, please contact:
Investor Contact:
212-915-2569
jallaire@lifesciadvisors.com
Media Contact:
mpurpura@lifesciadvisors.com
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 | $ | (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 | ||||||
Condensed Balance Sheets (in thousands) | ||||||||
2023 | 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 |
Source:
2024 GlobeNewswire, Inc., source