- Final results from RMCL-002 Phase 2 trial to be presented in the Late Breaking Clinical Trials session at the
European Renal Association (ERA) Congress onMay 25, 2024 . An investor call to provide a perspective on CKD with Dr.Arnold Silva and Dr.Steven Coca and a recap of the RMCL-002 data is planned forMay 28, 2024 - On schedule to resume manufacturing and
PROACT 1 Phase 3 trial, commencePROACT 2 Phase 3 trial, and readout interim results from the ongoing REGEN-007 Phase 2 trial in mid-2024 - Strengthened leadership team with appointment of two key hires across Clinical and Technical Operations
- Ended the first quarter with
$329 million in cash and cash equivalents and marketable securities, supporting operating plans into Q4 2025
“With the full results of RMCL-002 to be presented at the
Clinical Updates
- ERA
Congress inStockholm, Sweden fromMay 23-26, 2024 .ProKidney will present the Phase 2 RMCL-002 final results abstract titled “Rilparencel Renal Autologous Cell Therapy for Patients with Stage 3-4 CKD and Type 2 Diabetes: Results from a Phase 2 Clinical Trial” in the Late Breaking Clinical Trials session at15:30-15:45 CEST onMay 25, 2024 . An investor call to provide a perspective on CKD with Dr.Arnold Silva and Dr.Steven Coca and a recap of the RMCL-002 data is planned forMay 28, 2024 . Further details will be provided. - The PROACT 1 Phase 3 study (REGEN-006) protocol amendment has been completed and was submitted to the FDA in late March. This amendment updated the protocol to focus on patients with higher risk of kidney failure. In the PROACT 1 Phase 3 clinical study, the eGFR enrollment range will be modified from the current range of ≥ 20 to ≤ 50 ml/min/1.73m2 to a new range of ≥ 20 to ≤ 35 ml/min/1.73m2. The Company believes that focusing on patients with more severe CKD will better align with RMCL-002 results and feedback from payers and providers. The Company continues to expect
PROACT 1 will resume enrollment, andPROACT 2 will commence enrollment, in mid-2024.
Corporate Updates
Bank of America Securities Health Care Conference inLas Vegas, NV fromMay 14-16, 2024 . Senior members of the management team will be participating in a fireside chat and one-on-one meetings at the upcoming conference. Interested investors should contact their Bank of America representative to schedule meetings.- Appointment of
Ulrich Ernst , Ph.D as Executive Vice President of Technical Operations. In March, the Company announcedDr. Ernst joined as EVP of Technical Operations and as part of theProKidney Executive Leadership Team.Dr. Ernst brings over 30 years of experience in the biopharmaceutical industry with a focus on process development, manufacturing and facility oversight, and supply chain operations in the cell space. Prior toProKidney ,Dr. Ernst was Senior Vice President of Technical Operations at Iovance Biotherapeutics, Chief Operating Officer atAmunix Operating Inc. , and Senior Vice President of Manufacturing Operations atCytovance Biologics . - Appointment of
Lucio Tozzi as Senior Vice President of Global Clinical Operations. In January,Mr. Tozzi joined as SVP of Global Clinical Operations.Mr. Tozzi also brings over 30 years of experience in international drug development and execution of clinical trials across multiple therapeutic categories. Prior toProKidney ,Mr. Tozzi was Senior Vice President and Head of Clinical Operations at Summit Therapeutics and Rain Oncology, and, prior to that, Vice President of Clinical Operations at Protagonist Therapeutics.
First Quarter 2024 Financial Highlights
Liquidity: Cash, cash equivalents and marketable securities as of
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss Before Noncontrolling Interest: Net loss before noncontrolling interest was
Shares outstanding: Class A and Class B ordinary shares outstanding as of
About
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. ProKidney’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to financial results and expected cash runway, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company’s products, if approved, potential regulatory approvals, the size and potential growth of current or future markets for the Company’s products, if approved, the advancement of the Company’s development programs into and through the clinic and the expected timing for reporting data, the making of regulatory filings or achieving other milestones related to related to the Company’s product candidates, and the advancement and funding of the Company’s developmental programs generally. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the inability to maintain the listing of the Company’s Class A ordinary shares on the Nasdaq; the inability to implement business plans, forecasts, and other expectations or identify and realize additional opportunities, which may be affected by, among other things, competition and the ability of the Company to grow and manage growth profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the Company’s products, if approved, and its ability to serve those markets, either alone or in partnership with others; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s financial performance; the Company’s intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the fact that interim results from our clinical programs may not be indicative of future results; the impact of geo-political conflict on the Company’s business; and other risks and uncertainties included under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other filings with the
Investor Contacts:
Ethan.Holdaway@prokidney.com
Daniel@lifesciadvisors.com
Condensed Consolidated Balance Sheets (in thousands, except for share data) | |||||||
(Unaudited) | |||||||
Assets | |||||||
Cash and cash equivalents | $ | 84,389 | $ | 60,649 | |||
Marketable securities | 244,609 | 302,301 | |||||
Interest receivable | 1,903 | 1,375 | |||||
Prepaid assets | 3,106 | 3,399 | |||||
Prepaid clinical | 6,151 | 6,413 | |||||
Other current assets | — | 9 | |||||
Total current assets | 340,158 | 374,146 | |||||
Fixed assets, net | 41,937 | 42,143 | |||||
Right of use assets, net | 5,668 | 4,263 | |||||
Total assets | $ | 387,763 | $ | 420,552 | |||
Liabilities and Shareholders' Deficit | |||||||
Accounts payable | $ | 3,376 | $ | 5,098 | |||
Lease liabilities | 1,092 | 803 | |||||
Accrued expenses and other | 13,263 | 17,665 | |||||
Income taxes payable | 1,570 | 1,472 | |||||
Total current liabilities | 19,301 | 25,038 | |||||
Income tax payable, net of current portion | 568 | 568 | |||||
Lease liabilities, net of current portion | 4,859 | 3,610 | |||||
Total liabilities | 24,728 | 29,216 | |||||
Commitments and contingencies | |||||||
Redeemable noncontrolling interest | 1,459,097 | 1,494,732 | |||||
Shareholders’ deficit | |||||||
Class A ordinary shares, authorized; 61,621,330 and 59,880,347 issued and outstanding as of | 6 | 6 | |||||
Class B ordinary shares, authorized; 167,723,553 and 168,297,916 issued and outstanding as of | 17 | 17 | |||||
Additional paid-in capital | 53,114 | 36,114 | |||||
Accumulated other comprehensive (loss) gain | (44 | ) | 130 | ||||
Accumulated deficit | (1,149,155 | ) | (1,139,663 | ) | |||
Total shareholders' deficit | (1,096,062 | ) | (1,103,396 | ) | |||
Total liabilities and shareholders' deficit | $ | 387,763 | $ | 420,552 |
Condensed Consolidated Statements of Operations – Unaudited (in thousands, except for share and per share data) | ||||||||
Three Months Ended | ||||||||
2024 | 2023 | |||||||
Operating expenses | ||||||||
Research and development | $ | 27,233 | $ | 25,617 | ||||
General and administrative | 12,843 | 15,259 | ||||||
Total operating expenses | 40,076 | 40,876 | ||||||
Operating loss | (40,076 | ) | (40,876 | ) | ||||
Other income (expense): | ||||||||
Interest income | 4,843 | 5,297 | ||||||
Interest expense | (2 | ) | (3 | ) | ||||
Net loss before income taxes | (35,235 | ) | (35,582 | ) | ||||
Income tax expense | 98 | 1,327 | ||||||
Net loss before noncontrolling interest | (35,333 | ) | (36,909 | ) | ||||
Net loss attributable to noncontrolling interest | (25,841 | ) | (27,244 | ) | ||||
Net loss available to Class A ordinary shareholders | $ | (9,492 | ) | $ | (9,665 | ) | ||
Weighted average Class A ordinary shares outstanding: | ||||||||
Basic and diluted | 60,951,721 | 61,540,231 | ||||||
Net loss per share attributable to Class A ordinary shares: | ||||||||
Basic and diluted | $ | (0.16 | ) | $ | (0.16 | ) |
Condensed Consolidated Statements of Cash Flows – Unaudited (in thousands) | ||||||||
Three Months Ended | ||||||||
2024 | 2023 | |||||||
Cash flows from operating activities | ||||||||
Net loss before noncontrolling interest | $ | (35,333 | ) | $ | (36,909 | ) | ||
Adjustments to reconcile net loss before noncontrolling interest to net cash flows used in operating activities: | ||||||||
Depreciation and amortization | 1,102 | 832 | ||||||
Equity-based compensation | 7,679 | 13,020 | ||||||
Gain on marketable securities, net | (2,313 | ) | (492 | ) | ||||
Loss on disposal of equipment | 28 | 3 | ||||||
Changes in operating assets and liabilities | ||||||||
Interest receivable | (529 | ) | (5,476 | ) | ||||
Prepaid and other assets | 564 | 3,483 | ||||||
Accounts payable and accrued expenses | (5,942 | ) | (601 | ) | ||||
Income taxes payable | 98 | 148 | ||||||
Net cash flows used in operating activities | (34,646 | ) | (25,992 | ) | ||||
Cash flows from investing activities | ||||||||
Purchases of marketable securities | (55,415 | ) | (198,038 | ) | ||||
Sales and maturities of marketable securities | 114,774 | 6,412 | ||||||
Purchase of equipment and facility expansion | (960 | ) | (986 | ) | ||||
Net cash flows provided by (used in) investing activities | 58,399 | (192,612 | ) | |||||
Cash flows from financing activities | ||||||||
Payments on finance leases | (13 | ) | (13 | ) | ||||
Net cash flows used in financing activities | (13 | ) | (13 | ) | ||||
Net change in cash and cash equivalents | 23,740 | (218,617 | ) | |||||
Cash, beginning of period | 60,649 | 490,252 | ||||||
Cash, end of period | $ | 84,389 | $ | 271,635 | ||||
Supplemental disclosure of non-cash investing and financing activities: | ||||||||
Right of use assets obtained in exchange for lease obligations | $ | 1,674 | $ | 714 | ||||
Exchange of Class B ordinary shares | $ | 2,289 | $ | – | ||||
Impact of equity transactions and compensation on redeemable noncontrolling interest | $ | 7,507 | $ | 1,352 | ||||
Change in redemption value of noncontrolling interest | $ | – | $ | 509,526 | ||||
Equipment and facility expansion included in accounts payable and accrued expenses | $ | 305 | $ | 744 |
Source:
2024 GlobeNewswire, Inc., source