“In the second quarter, and throughout the first half of 2023, we steadily advanced our REACT development programs, including our initial Phase 3 study, proact 1, that is assessing the potential for REACT to delay or halt the progression of moderate to severe diabetic CKD,” said Dr.
Recent Corporate Highlights, and REACT® Clinical Development Updates
- Closed on purchase of a 210,000 square foot facility and approximately 22 acres of land in
Greensboro, N.C. , that will support future potential commercial manufacturing needs for REACT. Received an incentive package totaling up to approximately$33.7 million in tax credits, as well as up to$1.9 million in energy credits from Duke Energy. Receipt of these incentives is based upon the achievement of certain milestones, including the creation of at least 330 new jobs on or beforeDecember 31, 2028 , and project investment of approximately$458 million made, or caused to be made, by the company in real and personal property byDecember 31, 2027 . - Continued enrolling subjects in proact 1, a Phase 3 randomized, blinded, sham-controlled study evaluating up to two doses of REACT given three months apart, with one dose delivered into each kidney. The study’s target enrollment is 600 patients at sites in the
U.S. ,UK and select other countries at high risk for progressing to kidney failure, with initial interim data expected by the end of 2024. - Continued preparation to initiate patient enrollment in proact 2, a Phase 3 randomized, blinded, sham-controlled study to assess the safety and efficacy of up to two REACT injections, given three months apart, and delivered once into each kidney, for patients primarily in the EU,
Latin America andAsia Pacific regions. The Company recently implemented protocol modifications to reflect the evolving standard-of-care, ongoing regulatory interactions, and facilitation of potential commercial access. These modifications include a long-term (60 month) follow-up period and stratification at randomization based on CKD stage and SGLT2 or sMRA use. Protocol allowances have been received inAustralia ,Belgium ,Brazil ,Columbia ,France ,Italy ,Malaysia ,Portugal ,Singapore , andSpain .ProKidney expects to commence enrollment in the second half of 2023 with initial interim data expected by the end of 2025. - Presented a poster on REGEN-007 patient demographics at the 60th
European Renal Association (ERA) Congress .
Second Quarter 2023 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 at
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 COVID-19 or geo-political conflict such as the war in
Contacts:
Corporate:
SVP, Investor Relations
glenn.schulman@prokidney.com
Investors:
lroth@burnsmc.com / jweilman@burnsmc.com
Media:
shusain@burnsmc.com / rflamm@burnsmc.com
Consolidated Balance Sheets (in thousands, except for share data) | |||||||
(Unaudited) | |||||||
Assets | |||||||
Cash and cash equivalents | $ | 243,553 | $ | 490,252 | |||
Marketable securities | 202,575 | – | |||||
Interest receivable | 8,090 | – | |||||
Prepaid assets | 4,226 | 2,624 | |||||
Prepaid clinical | 7,385 | 10,459 | |||||
Other current assets | 603 | 1,384 | |||||
Total current assets | 466,432 | 504,719 | |||||
Fixed assets, net | 14,803 | 10,708 | |||||
Right of use assets, net | 2,880 | 2,356 | |||||
Intangible assets, net | 106 | 213 | |||||
Total assets | $ | 484,221 | $ | 517,996 | |||
Liabilities and Shareholders' Deficit/Members' Equity | |||||||
Accounts payable | $ | 2,832 | $ | 3,044 | |||
Lease liabilities | 654 | 493 | |||||
Accrued expenses and other | 20,945 | 7,336 | |||||
Income taxes payable | 66 | – | |||||
Total current liabilities | 24,497 | 10,873 | |||||
Income tax payable, net of current portion | 494 | 278 | |||||
Lease liabilities, net of current portion | 2,286 | 1,906 | |||||
Total liabilities | 27,277 | 13,057 | |||||
Commitments and contingencies | |||||||
Redeemable noncontrolling interest | 1,779,198 | 1,601,555 | |||||
Shareholders’ deficit / members' equity: | |||||||
Class A ordinary shares, | 6 | 6 | |||||
Class B ordinary shares, | 18 | 18 | |||||
Additional paid-in capital | 30,957 | 7,476 | |||||
Accumulated other comprehensive loss | (127 | ) | – | ||||
Accumulated deficit | (1,353,108 | ) | (1,104,116 | ) | |||
Total shareholders' deficit / members’ equity | (1,322,254 | ) | (1,096,616 | ) | |||
Total liabilities and shareholders' deficit/members' equity | $ | 484,221 | $ | 517,996 |
Consolidated Statements of Operations and Comprehensive Loss (in thousands, except for share and per share data) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses | ||||||||||||||||
Research and development | $ | 26,364 | $ | 11,558 | $ | 51,981 | $ | 40,048 | ||||||||
General and administrative | 13,455 | 9,180 | 28,714 | 47,152 | ||||||||||||
Total operating expenses | 39,819 | 20,738 | 80,695 | 87,200 | ||||||||||||
Operating loss | (39,819 | ) | (20,738 | ) | (80,695 | ) | (87,200 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 5,965 | – | 11,262 | – | ||||||||||||
Interest expense | (4 | ) | (170 | ) | (7 | ) | (184 | ) | ||||||||
Net loss before income taxes | (33,858 | ) | (20,908 | ) | (69,440 | ) | (87,384 | ) | ||||||||
Income tax expense | 965 | 1,223 | 2,292 | 2,233 | ||||||||||||
Net loss before noncontrolling interest | (34,823 | ) | (22,131 | ) | (71,732 | ) | (89,617 | ) | ||||||||
Net loss attributable to noncontrolling interest | (25,705 | ) | – | (52,949 | ) | – | ||||||||||
Net loss available to Class A ordinary shareholders | $ | (9,118 | ) | $ | (22,131 | ) | $ | (18,783 | ) | $ | (89,617 | ) | ||||
Weighted average Class A ordinary shares outstanding: (1) | ||||||||||||||||
Basic and diluted | 64,562,209 | 64,551,281 | ||||||||||||||
Net loss per share attributable to Class A ordinary shares: (1) | ||||||||||||||||
Basic and diluted | $ | (0.14 | ) | $ | (0.29 | ) |
(1) The Company analyzed the calculation of net loss per share for periods prior to the business combination with
Consolidated Statements of Cash Flows (in thousands) | ||||||||
Six Months Ended | ||||||||
2023 | 2022 | |||||||
Cash flows from operating activities | ||||||||
Net loss before noncontrolling interest | $ | (71,732 | ) | $ | (89,617 | ) | ||
Adjustments to reconcile net loss before noncontrolling interest to net cash flows used in operating activities: | ||||||||
Depreciation and amortization | 1,702 | 1,462 | ||||||
Equity-based compensation | 24,222 | 60,685 | ||||||
Gain on marketable securities, net | (1,981 | ) | – | |||||
Loss on disposal of equipment | 3 | – | ||||||
Changes in operating assets and liabilities | ||||||||
Interest receivable | (8,090 | ) | – | |||||
Deferred offering costs | – | (6,905 | ) | |||||
Prepaid and other assets | 2,256 | (5,320 | ) | |||||
Accounts payable and accrued expenses | 12,430 | (520 | ) | |||||
Income taxes payable | 282 | 1,730 | ||||||
Net cash flows used in operating activities | (40,908 | ) | (38,485 | ) | ||||
Cash flows used in investing activities | ||||||||
Purchases of marketable securities | (261,847 | ) | – | |||||
Sales of marketable securities | 60,768 | – | ||||||
Purchase of equipment and facility expansion | (4,686 | ) | (1,225 | ) | ||||
Net cash flows used in investing activities | (205,765 | ) | (1,225 | ) | ||||
Cash flows from financing activities | ||||||||
Payments on finance leases | (26 | ) | (16 | ) | ||||
Borrowings under related party notes payable | – | 35,000 | ||||||
Net cash contribution | – | 6,050 | ||||||
Net cash flows (used in) provided by financing activities | (26 | ) | 41,034 | |||||
Net change in cash and cash equivalents | (246,699 | ) | 1,324 | |||||
Cash, beginning of period | 490,252 | 20,558 | ||||||
Cash, end of period | $ | 243,553 | $ | 21,882 | ||||
Supplemental disclosure of non-cash investing activities: | ||||||||
Right of use assets obtained in exchange for lease obligations | $ | 714 | $ | 878 | ||||
Impact of equity transactions and compensation on redeemable noncontrolling interest | $ | 380 | $ | – | ||||
Change in redemption value of noncontrolling interest | $ | 230,209 | $ | – | ||||
Equipment and facility expansion included in accounts payable and accrued expenses | $ | 689 | $ | 529 |
Source:
2023 GlobeNewswire, Inc., source