PROKIDNEY CORP. “During the first half of 2022, we continued to execute on our clinical and operational plan, positioning us well to achieve our near- and longer-term strategic objectives,” said
Recent Business Highlights
ProKidney completed its previously announced business combination with SCS and commenced trading of the combined company’s Class A ordinary shares on the Nasdaq Capital Market under the ticker symbol “PROK.” As a result of the business combination,ProKidney received gross proceeds of$596.5 million , before transaction fees and related costs, which the Company believes will be sufficient to fund operations through data from its ongoing Phase 3 registrational program for REACT™ targeting diabetic CKD. All other financial and operating results in this release are for the business ofProKidney and its subsidiaries and do not give effect to the closing of the business combination, which occurred onJuly 11, 2022 (after the close of the quarter endedJune 30 , 2022).- We continue to enroll subjects in the
U.S. Phase 3 study (REGEN -006) to assess the efficacy of up to two REACT™ injections, given three months apart, and delivered once into each kidney. - Expanded target enrollment for
REGEN -007 from 30 subjects to up to 50 subjects.REGEN -007 is an ongoing, prospective, randomized, open-label, repeat dose, double-arm, controlled safety and efficacy study of REACT™ in subjects with type 1 or 2 diabetes and CKD, in which one injection of REACT™ will occur in each kidney. - Our highly experienced leadership team was expanded and strengthened through the recruitment of highly qualified personnel to support operations. Recent additions to the
ProKidney team includeTodd Girolamo , Chief Legal Officer and Corporate Secretary, Dr.Libbie McKenzie , Chief Medical Officer and Dr.Kerry Cooper , Senior Vice President of Medical Affairs. - Strengthened Board of Directors with the appointments of Dr.
John M. Maraganore , founding chief executive officer of Alnylam Pharmaceuticals, Inc. andJennifer Fox , Chief Financial Officer of Nuvation Bio.
Second Quarter Financial Highlights of
Cash Position: Cash and cash equivalents as of
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Income Tax Expense: Income tax expense was
Net Loss per Share: Diluted net loss per share was
About
About CKD
There are no therapies that effectively reverse late-stage CKD. CKD is a serious diagnosis with significant morbidity and mortality, notable for the 5-year mortality of a new diagnosis of CKD Stage 4 being higher than that of a new non-metastatic cancer diagnosis. CKD most often presents as a progressive decline in kidney function ultimately resulting in the failure of the kidneys and the need for renal replacement therapy, such as hemodialysis, or kidney transplant. One in three Americans is at risk for CKD which currently affects approximately 75 million people in
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, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company’s products, if approved, potential regulatory approvals, and the size and potential growth of current or future markets for the Company’s products, if approved. 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 impact of COVID-19 or geo-political conflict such as the war in
| Condensed Consolidated Balance Sheets | |||||||
| (in thousands) | |||||||
| (Unaudited) | |||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 21,882 | $ | 20,558 | |||
| Prepaid assets | 682 | 588 | |||||
| Prepaid clinical | 11,350 | 6,100 | |||||
| Other current assets | — | 25 | |||||
| Total current assets | 33,914 | 27,271 | |||||
| Fixed assets, net | 10,857 | 11,358 | |||||
| Right of use assets, net | 1,962 | 1,241 | |||||
| Deferred offering costs | 6,905 | – | |||||
| Intangible assets, net | 320 | 428 | |||||
| Total assets | $ | 53,958 | $ | 40,298 | |||
| Liabilities and Equity | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 2,513 | $ | 2,834 | |||
| Lease liabilities | 377 | 267 | |||||
| Accrued expenses and other | 6,184 | 9,213 | |||||
| Income taxes payable | 1,730 | — | |||||
| Related party notes payable | 35,000 | — | |||||
| Total current liabilities | 45,804 | 12,314 | |||||
| Lease liabilities, net of current portion | 1,617 | 1,067 | |||||
| Members’ equity: | |||||||
| Class A Units (186,500,000 issued and outstanding as of June 30, 2022 and | 186,500 | 186,500 | |||||
| Class | 71,164 | 1,927 | |||||
| Accumulated deficit | (251,127 | ) | (161,510 | ) | |||
| Total members’ equity | 6,537 | 26,917 | |||||
| Total liabilities and equity | $ | 53,958 | $ | 40,298 | |||
| Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (in thousands, except for share and per share data) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 11,558 | $ | 10,969 | $ | 40,048 | $ | 20,828 | ||||||||
| General and administrative | 9,180 | 1,748 | 47,152 | 3,492 | ||||||||||||
| Total operating expenses | 20,738 | 12,717 | 87,200 | 24,320 | ||||||||||||
| Operating loss | (20,738 | ) | (12,717 | ) | (87,200 | ) | (24,320 | ) | ||||||||
| Interest income | — | 2 | — | 2 | ||||||||||||
| Interest expense | (170 | ) | — | (184 | ) | — | ||||||||||
| Net loss before income taxes | (20,908 | ) | (12,715 | ) | (87,384 | ) | (24,318 | ) | ||||||||
| Income tax expense | 1,223 | 10 | 2,233 | 16 | ||||||||||||
| Net and comprehensive loss | $ | (22,131 | ) | $ | (12,725 | ) | $ | (89,617 | ) | $ | (24,334 | ) | ||||
| Weighted average Class A Units outstanding: | ||||||||||||||||
| Basic and diluted | 186,500,000 | 140,109,890 | 186,500,000 | 131,160,221 | ||||||||||||
| Net loss per Class A Unit: | ||||||||||||||||
| Basic and diluted | $ | (0.12 | ) | $ | (0.09 | ) | $ | (0.48 | ) | $ | (0.19 | ) | ||||
| Unaudited Condensed Consolidated Statements of Cash Flows | ||||||||
| (in thousands) | ||||||||
| Six Months Ended | ||||||||
| 2022 | 2021 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (89,617 | ) | $ | (24,334 | ) | ||
| Adjustments to reconcile net loss to net cash flows | ||||||||
| Depreciation and amortization | 1,462 | 878 | ||||||
| Equity-based compensation | 60,685 | 350 | ||||||
| Changes in operating assets and liabilities | ||||||||
| Deferred offering costs | (6,905 | ) | – | |||||
| Prepaid and other assets | (5,320 | ) | (4,896 | ) | ||||
| Accounts payable and accrued expenses | (520 | ) | 8,907 | |||||
| Income taxes payable | 1,730 | — | ||||||
| Net cash flows used in operating activities | (38,485 | ) | (19,095 | ) | ||||
| Cash flows used in investing activities | ||||||||
| Purchase of equipment and facility expansion | (1,225 | ) | (3,393 | ) | ||||
| Net cash flows used in investing activities | (1,225 | ) | (3,393 | ) | ||||
| Cash flows from financing activities | ||||||||
| Payments on finance leases | (16 | ) | (15 | ) | ||||
| Borrowings under related party notes payable | 35,000 | — | ||||||
| Net cash contribution | 6,050 | 30,000 | ||||||
| Net cash flows provided by financing activities | 41,034 | 29,985 | ||||||
| Net change in cash and cash equivalents | 1,324 | 7,497 | ||||||
| Cash, beginning of period | 20,558 | 4,577 | ||||||
| Cash, end of period | $ | 21,882 | $ | 12,074 | ||||
| Supplemental disclosure of non-cash investing activities: | ||||||||
| Right of use assets obtained in exchange for lease obligations | $ | 878 | $ | – | ||||
| Equipment and facility expansion included in accounts payable and accrued expenses | $ | 529 | $ | 635 | ||||
Contact:
Investors:
lroth@burnsmc.com
+1 (212) 300-8331
2022 GlobeNewswire, Inc., source
