Summary of Vera Therapeutics FY Conference Call Company Overview - **Company**: Vera Therapeutics (NasdaqGM:VERA) - **Founded**: 2016 in San Francisco - **Lead Product**: Atacicept, a first-in-class dual BAFF/APRIL inhibitor - **Financial Position**: Pro forma cash of $779 million with 71.3 million shares outstanding [4][5] Industry Context - **Primary Indication**: IgA nephropathy (IgAN), the most common primary glomerular disease worldwide, with an incidence of 2.5 per 100,000 people [6] - **Market Size**: Estimated 160,000 diagnosed IgAN patients in the U.S., with half in the highest-risk category [14] - **Competitive Landscape**: Five new drugs approved for IgAN in the past five years, indicating a growing market with premium pricing [16] Key Product Insights - **Atacicept Mechanism**: Targets BAFF and APRIL to modulate B-cell function, potentially avoiding immune suppression challenges [3][5] - **Clinical Trials**: - Phase III trial met primary endpoint with a 42% placebo-adjusted reduction in proteinuria at 36 weeks [11] - Secondary endpoints showed consistent results with phase II data [11] - Ongoing trials include PIONEER, studying Atacicept in moderate and low-risk patients [15] Regulatory and Commercialization Plans - **BLA Submission**: Submitted to the U.S. FDA with priority review status; PDUFA date set for July 7, 2026 [3][18] - **Commercial Launch**: Expected in July 2026, with a focus on educating nephrologists about Atacicept [13][21] - **Sales Force**: Hiring 82 sales representatives to target over half of the 11,000 nephrologists in the U.S. [23] Clinical Efficacy and Safety - **Efficacy Measures**: Aims to stabilize eGFR, reduce proteinuria, and resolve kidney inflammation [9][12] - **Safety Profile**: Atacicept showed a low rate of serious adverse events (0.5%) and was well tolerated [12] Future Opportunities - **Expansion Potential**: Atacicept has therapeutic potential in other autoimmune diseases, with an estimated addressable market of 1.2 million patients in the U.S. [17][18] - **Pipeline Development**: Ongoing studies for additional indications and formulations, including a monthly dosing option [29][31] Conclusion - **Transformative Year Ahead**: Vera Therapeutics is positioned for significant growth in 2026 with the anticipated launch of Atacicept and ongoing clinical trials [18][34]

As filed with the Securities and Exchange Commission June 5, 2024 Registration Statement No. 333-276588 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 4 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ADITXT, INC. (Exact name of registrant as specified in its charter) (Primary Standard Industrial Delaware 23219 82-3204328 (I.R.S. Employer Identification Number) Classification Code Number) 2569 Wyandotte St., Suite 101 Mountainview, CA 94043 (650) 87 ...

As filed with the Securities and Exchange Commission February 14, 2024 Registration Statement No. 333-276588 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ADITXT, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 23219 82-3204328 (I.R.S. Employer Identification N ...

As filed with the Securities and Exchange Commission January 26, 2024 Registration Statement No. 333-276588 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ADITXT, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 23219 82-3204328 (I.R.S. Employer Identification Nu ...

As filed with the Securities and Exchange Commission January 18, 2024 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ADITXT, INC. (Exact name of registrant as specified in its charter) 737 N. Fifth Street, Suite 200 Richmond, VA 23219 (650) 870-1200 (Address and telephone number of registrant's principal executive offices) (State or other jurisdiction of incorporation or organization) (P ...

As filed with the Securities and Exchange Commission November 7, 2023 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ADITXT, INC. (Exact name of registrant as specified in its charter) Delaware 23219 82-3204328 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 737 N. Fifth Street ...

As filed with the Securities and Exchange Commission September 15, 2023 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ADITXT, INC. (Exact name of registrant as specified in its charter) Delaware 23219 82-3204328 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 737 N. Fifth Street, Suite 200 Richmond, VA 23219 (650) 870-1200 (Address and te ...

As filed with the Securities and Exchange Commission June 28, 2023 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ADITXT, INC. (Exact name of registrant as specified in its charter) Delaware 23219 82-3204328 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer If any of the securities being registered on ...

Registration No. 333- As filed with the Securities and Exchange Commission on March 22, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ZIVO BIOSCIENCE, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Nevada 2836 87-0699977 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 21 East Long Lake Road ...