UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition
On November 10, 2021, Vera Therapeutics, Inc. (the “Company”) issued a press release providing a corporate update for the quarter ended September 30, 2021. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
|
Description |
99.1 |
|
Press Release of Vera Therapeutics, Inc., dated November 10, 2021. |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
Vera Therapeutics, Inc. |
|
|
|
|
Date: |
November 10, 2021 |
By: |
/s/ Sean Grant |
|
|
|
Sean Grant, Chief Financial Officer |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Vera Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update
SOUTH SAN FRANCISCO, Calif.,November 10,2021 – Vera Therapeutics, Inc. (Nasdaq: VERA), a clinical-stage biotechnology company focused on developing treatments for immunological diseases that improve patients’ lives, today reported its business highlights and financial results for the quarter ending September 30, 2021, and provided a corporate update.
“Vera’s third-quarter highlights show continued progress on our business objectives. We remain well-positioned as we continue to advance the clinical program for atacicept, evaluating its potential for patients who suffer from the devastating effects of kidney disease and are lacking effective treatment options,” said Marshall Fordyce, MD, founder and CEO of Vera Therapeutics. “We are pleased by the analysis of our Phase 2a study demonstrating atacicept 75mg reduces Gd-IgA1 to the lowest risk quartile. We continue to make progress enrolling our ongoing Phase 2b ORIGIN study of atacicept in patients with IgA nephropathy – a study powered for proteinuria, and designed to demonstrate atacicept as the first disease-modifying therapy for this indication. We also look forward to the response from the FDA in the fourth quarter of 2021 on our proposed clinical development strategy for atacicept to treat lupus nephritis.”
Third Quarter and Recent Business Highlights
“Research has shown that higher levels of Gd-IgA1 are associated with increased risk of end-stage renal disease or death. The new analysis from the Phase 2a JANUS clinical trial presented at Kidney Week 2021 showed that atacicept substantially reduced Gd-IgA1. We are optimistic for even greater efficacy and durability from the 150mg dose of atacicept in the ORIGIN study and look forward to providing initial results from the ORIGIN trial in the fourth quarter of 2022,” added Dr. Fordyce.
Financial Results for the Quarter Ended September 30, 2021
For the three months ended September 30, 2021, the company reported a net loss of $7.6 million, or a net loss per diluted share of $0.36, compared to a net loss of $4.5 million, or a net loss per diluted share of $13.68, for the same period last year. Outstanding shares of redeemable convertible preferred stock were excluded from the computation of net loss per diluted share for periods prior to the conversion of those shares to common stock in May 2021.
During the nine months ended September 30, 2021, net cash used in operating activities was $17.3 million, compared to $7.4 million for the same period last year.
Vera reported approximately $86.2 million in cash and cash equivalents as of September 30, 2021.
About Atacicept
Atacicept is a novel, disease-modifying fully humanized fusion protein that is a dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) 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 immunologic diseases, including IgA nephropathy (IgAN), also known as Berger’s disease, and systemic lupus erythematosus. Vera believes that atacicept has the potential to be the best-in-class and the leading B cell-targeted therapy for IgAN. Atacicept has been well tolerated and has been used in clinical trials of more than 1,500 patients to date. In a clinical trial of IgAN patients, data show atacicept is the first known molecule to substantially reduce galactose-deficient immunoglobulin A (Gd-IgA1).
About Vera
Vera Therapeutics is a 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 lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN). For more information, please visit www.veratx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts 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, the clinical development and regulatory review process of atacicept and the timing of results from the ORIGIN trial. 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 “plans,” “will”, “anticipates,” “goal,” “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 and uncertainties associated with Vera’s business in general, the impact of the COVID-19 pandemic, 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.
Contacts
Investor Contact:
IR@veratx.com
Media Contact:
Greig Communications, Inc.
Kathy Vincent
(310) 403-8951
kathy@greigcommunications.com
VERA THERAPEUTICS, INC.
Unaudited Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
September 30, |
|
|
September 30, |
|
||||||||||
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
3,564 |
|
|
$ |
1,969 |
|
|
$ |
9,731 |
|
|
$ |
5,362 |
|
General and administrative |
|
|
3,688 |
|
|
|
652 |
|
|
|
8,086 |
|
|
|
2,903 |
|
Restructuring Costs |
|
|
- |
|
|
|
1,416 |
|
|
|
- |
|
|
|
1,416 |
|
Total operating expenses |
|
|
7,252 |
|
|
|
4,037 |
|
|
|
17,817 |
|
|
|
9,681 |
|
Loss from operations |
|
|
(7,252 |
) |
|
|
(4,037 |
) |
|
|
(17,817 |
) |
|
|
(9,681 |
) |
Total other income (expense), net |
|
|
(359 |
) |
|
|
(423 |
) |
|
|
2,055 |
|
|
|
(857 |
) |
Net loss and comprehensive loss |
|
$ |
(7,611 |
) |
|
$ |
(4,460 |
) |
|
$ |
(15,762 |
) |
|
$ |
(10,538 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(0.36 |
) |
|
$ |
(13.68 |
) |
|
$ |
(1.46 |
) |
|
$ |
(32.64 |
) |
|
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
|
21,265,519 |
|
|
|
325,985 |
|
|
|
10,793,436 |
|
|
|
322,811 |
|
|
VERA THERAPEUTICS, INC.
Unaudited Balance Sheets
(in thousands)
|
September 30, |
|
|
December 31, |
|
||
|
2021 |
|
|
2020 |
|
||
Assets |
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
||
Cash and cash equivalents |
$ |
86,191 |
|
|
$ |
53,654 |
|
Restricted cash, current |
|
- |
|
|
|
50 |
|
Prepaid expenses and other current assets |
|
3,569 |
|
|
|
557 |
|
Total current assets |
|
89,760 |
|
|
|
54,261 |
|
Restricted cash, noncurrent |
|
293 |
|
|
|
293 |
|
Non-marketable equity securities |
|
1,114 |
|
|
|
- |
|
Total assets |
$ |
91,167 |
|
|
$ |
54,554 |
|
|
|
|
|
|
|
||
Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) |
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
||
Accounts payable |
$ |
964 |
|
|
$ |
909 |
|
Restructuring liability, current |
|
367 |
|
|
|
962 |
|
Accrued expenses and other current liabilities |
|
2,711 |
|
|
|
535 |
|
Total current liabilities |
|
4,042 |
|
|
|
2,406 |
|
Restructuring liability, noncurrent |
|
1,362 |
|
|
|
1,634 |
|
Accrued and other noncurrent liabilities |
|
286 |
|
|
|
286 |
|
Total liabilities |
|
5,690 |
|
|
|
4,326 |
|
Redeemable convertible preferred stock |
|
- |
|
|
|
139,576 |
|
Stockholders' equity (deficit) |
|
|
|
|
|
||
Common stock |
|
21 |
|
|
|
- |
|
Additional paid-in-capital |
|
192,665 |
|
|
|
2,099 |
|
Accumulated deficit |
|
(107,209 |
) |
|
|
(91,447 |
) |
Total stockholders' equity (deficit) |
|
85,477 |
|
|
|
(89,348 |
) |
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) |
$ |
91,167 |
|
|
$ |
54,554 |
|
###