8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 24, 2021

 

 

Vera Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-40407   81-2744449

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

170 Harbor Way, 3rd Floor

South San Francisco, California

  94080
(Address of principal executive offices)   (Zip Code)

(650) 770-0077

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(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 (see General Instructions A.2. below):

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Class A common stock, $0.001 par value per share   VERA   The Nasdaq Stock Market LLC

 

 

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 June 24, 2021, Vera Therapeutics, Inc. (the “Company”) issued a press release providing a corporate update for the three months ended March 31, 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 June 24, 2021.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    Vera Therapeutics, Inc.
Dated: June 24, 2021      
   

By:

 

/s/ Marshall Fordyce, M.D.

     

Marshall Fordyce, M.D.

     

Chief Executive Officer

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

Vera Therapeutics Reports First Quarter 2021 Financial Results and Provides

Corporate Update

- - -

Completed an initial public offering with net proceeds, including the exercise of the

underwriters’ option in full, of approximately $48.4 million in May 2021

- - -

Expanded the management team to support initiation

of atacicept clinical development program

- - -

Initiated Phase 2b ORIGIN clinical trial of atacicept in patients with IgA nephropathy (IgAN)

SOUTH SAN FRANCISCO, Calif., June 24, 2021 – Vera Therapeutics, Inc. (Nasdaq: VERA), a clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its financial results for the first quarter ended March 31, 2021, and provided a corporate update.

“Over the past nine months, we completed two capital raises for a total of approximately $128.0 million with which we have launched our clinical development program for atacicept,” said Marshall Fordyce, MD, founder and chief executive officer of Vera Therapeutics. “We recently initiated the Phase 2b ORIGIN trial of atacicept to treat IgAN, which we believe could have a profound benefit for patients for whom there remains significant unmet medical need.”

First Quarter and Recent Business Highlights

 

   

Initiated the Phase 2b ORIGIN clinical trial, a dose-ranging study evaluating the safety and efficacy of atacicept in patients with IgA nephropathy (IgAN) who continue to have persistent proteinuria and remain at high risk of disease progression.

 

   

Appointed Celia Lin, MD, as Chief Medical Officer, who brings extensive clinical and industry experience in orphan diseases and multiple therapeutic areas, including nephrology and inflammation.

 

   

Appointed Tad Thomas, PhD, as Senior Vice President and Head of Product Development and Manufacturing to lead the Company’s process development, manufacturing, analytical sciences, and quality control operations.

 

   

Appointed Joseph Young, MBA, as Senior Vice President of Finance and Chief Accounting Officer to oversee finance and accounting, administration, and corporate operations.

 

   

Completed an initial public offering with net proceeds of approximately $48.4 million, including the underwriters’ exercise of their option in full, in May 2021.

 

   

Completed an approximately $80.0 million Series C financing in January 2021 led by Abingworth LLP. Other investors included Sofinnova Investments, Longitude Capital, Fidelity Management & Research Company LLC, Surveyor Capital (a Citadel company), Octagon Capital, Kleiner Perkins, GV (formerly Google Ventures), and Alexandria Venture Investments.


Financial Results for the Quarter Ended March 31, 2021

For the three months ended March 31, 2021, the Company reported a net loss of $4.7 million, or a net loss per diluted share of $12.23, compared to a net loss of $2.5 million, or a net loss per diluted share of $7.79, for the same period last year.

During the first quarter 2021, net cash used in operating activities was $4.1 million, compared to $2.3 million for the same period last year.

Vera reported approximately $49.5 million in cash and cash equivalents as of March 31, 2021. Subsequently, Vera completed an initial public offering of 5,002,500 shares of its Class A common stock, including the underwriters’ exercise of their option in full, for net proceeds of approximately $48.4 million in May 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 and commercializing transformative treatments for patients with serious immunological diseases. 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. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful, including lupus nephritis, a severe renal manifestation of systemic lupus erythematosus. 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 strength of Vera’s balance sheet and the adequacy of cash and cash equivalents on hand. 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
March 31,
 
     2021     2020  

Operating expenses:

    

Research and development

   $ 2,932     $ 1,439  

General and administrative

     1,784       1,032  
  

 

 

   

 

 

 

Total operating expenses

     4,716       2,471  
  

 

 

   

 

 

 

Loss from operations

     (4,716     (2,471

Total other income (expense)

     2       (3
  

 

 

   

 

 

 

Net loss and comprehensive loss

   $ (4,714   $ (2,474
  

 

 

   

 

 

 

Net loss per share attributable to common stockholders, basic and diluted

   $ (12.23   $ (7.79
  

 

 

   

 

 

 

Weighted-average shares of common stock outstanding, basic and diluted

     385,401       317,693  
  

 

 

   

 

 

 


VERA THERAPEUTICS, INC.

Condensed Balance Sheets

(in thousands)

 

     March 31,
2021
    December 31,
2020
 
Assets    (unaudited)        

Current assets:

    

Cash and cash equivalents

   $ 49,505     $ 53,654  

Restricted cash, current

     50       50  

Prepaid expenses and other current assets

     1,977       557  
  

 

 

   

 

 

 

Total current assets

     51,532       54,261  

Restricted cash, noncurrent

     293       293  
  

 

 

   

 

 

 

Total assets

   $ 51,825     $ 54,554  
  

 

 

   

 

 

 

Liabilities, redeemable convertible preferred stock, and stockholders’ deficit

 

 

Current liabilities:

    

Accounts payable

   $ 1,440     $ 909  

Restructuring liability, current

     515       962  

Accrued expenses and other current liabilities

     1,798       535  
  

 

 

   

 

 

 

Total current liabilities

     3,753       2,406  

Restructuring liability, noncurrent

     1,526       1,634  

Accrued and other noncurrent liabilities

     286       286  
  

 

 

   

 

 

 

Total liabilities

     5,565       4,326  

Redeemable convertible preferred stock

     139,576       139,576  

Stockholders’ deficit

    

Common stock

     —         —    

Additional paid-in-capital

     2,845       2,099  

Accumulated deficit

     (96,161     (91,447
  

 

 

   

 

 

 

Total stockholders’ deficit

     (93,316     (89,348
  

 

 

   

 

 

 

Total liabilities, redeemable convertible preferred stock, and stockholders’ deficit

   $ 51,825     $ 54,554  
  

 

 

   

 

 

 

# # #