ProKidney Reports Business Updates and Second Quarter 2024 Financial Results
ProKidney Corp. (PROK) reported Q2 2024 financial results and business updates. Key highlights include:
1. Presented interim REGEN-007 data showing kidney function stabilization in diabetes and advanced CKD patients.
2. Restarted manufacturing and resumed PROACT 1 and PROACT 2 Phase 3 trials.
3. Closed a $140 million upsized public offering, extending cash runway into mid-2026.
4. Ended Q2 with $431.5 million in cash and equivalents.
5. R&D expenses increased to $29.4 million, up from $26.4 million in Q2 2023.
6. G&A expenses slightly increased to $13.7 million from $13.5 million in Q2 2023.
7. Net loss before noncontrolling interest was $38.5 million, compared to $34.8 million in Q2 2023.
8. Appointed Carla Poulson as Chief People Officer.
ProKidney Corp. (PROK) ha riportato i risultati finanziari e gli aggiornamenti aziendali del secondo trimestre 2024. I punti salienti includono:
1. Presentati dati intermedi su REGEN-007 che mostrano la stabilizzazione della funzione renale nei pazienti con diabete e CKD avanzata.
2. Ripristinata la produzione e ripresi gli studi di fase 3 PROACT 1 e PROACT 2.
3. Chiusura di un'offerta pubblica aumentata di 140 milioni di dollari, estendendo la liquidità fino a metà 2026.
4. Chiusura del secondo trimestre con 431,5 milioni di dollari in contante e equivalenti.
5. Le spese per R&S sono aumentate a 29,4 milioni di dollari, rispetto ai 26,4 milioni di dollari del secondo trimestre 2023.
6. Le spese generali e amministrative sono leggermente aumentate a 13,7 milioni di dollari rispetto ai 13,5 milioni di dollari del secondo trimestre 2023.
7. Perdita netta prima delle partecipazioni non di controllo di 38,5 milioni di dollari, rispetto ai 34,8 milioni di dollari del secondo trimestre 2023.
8. Nomina di Carla Poulson come Chief People Officer.
ProKidney Corp. (PROK) reportó los resultados financieros y las actualizaciones comerciales del segundo trimestre de 2024. Los aspectos destacados incluyen:
1. Presentación de datos provisionales de REGEN-007 que muestran la estabilización de la función renal en pacientes con diabetes y enfermedad renal crónica avanzada.
2. Se reanudó la producción y se reiniciaron los ensayos de fase 3 PROACT 1 y PROACT 2.
3. Cerró una oferta pública ampliada de 140 millones de dólares, extendiendo el capital disponible hasta mediados de 2026.
4. Finalizó el segundo trimestre con 431,5 millones de dólares en efectivo y equivalentes.
5. Los gastos en I+D aumentaron a 29,4 millones de dólares, en comparación con 26,4 millones de dólares en el segundo trimestre de 2023.
6. Los gastos generales y administrativos aumentaron ligeramente a 13,7 millones de dólares desde 13,5 millones de dólares en el segundo trimestre de 2023.
7. La pérdida neta antes del interés no controlador fue de 38,5 millones de dólares, en comparación con 34,8 millones de dólares en el segundo trimestre de 2023.
8. Nombramiento de Carla Poulson como Jefa de Personas.
ProKidney Corp. (PROK)는 2024년 2분기 재무 결과와 사업 업데이트를 보고했습니다. 주요 내용은 다음과 같습니다:
1. 당뇨병 및 말기 만성 신장 질환(CKD) 환자에서 신장 기능 안정화가 나타난 REGEN-007의 중간 데이터 발표.
2. 생산을 재개하고 PROACT 1 및 PROACT 2 3상 시험을 다시 시작했습니다.
3. 1억 4천만 달러 규모의 공모를 마감하며 현금 유효기간을 2026년 중반까지 연장했습니다.
4. 2분기를 현금 및 현금성 자산 4억 3천1백5십만 달러로 마감했습니다.
5. 연구개발 비용이 2천9백40만 달러로 증가했으며, 2023년 2분기에는 2천6백40만 달러였습니다.
6. 일반 관리 비용이 1천3백70만 달러로 소폭 증가했으며, 2023년 2분기에는 1천3백50만 달러였습니다.
7. 비지배 지분을 제외한 순손실은 3천850만 달러로, 2023년 2분기에는 3천480만 달러였습니다.
8. Carla Poulson을 최고 인사 책임자로 임명했습니다.
ProKidney Corp. (PROK) a publié ses résultats financiers et ses mises à jour d'entreprise pour le deuxième trimestre 2024. Les points forts comprennent :
1. Présentation de données provisoires sur REGEN-007 montrant la stabilisation de la fonction rénale chez les patients diabétiques et atteints de maladies rénales chroniques avancées.
2. Reprise de la production et relance des essais de phase 3 PROACT 1 et PROACT 2.
3. Clôture d'une offre publique augmentée de 140 millions de dollars, étendant ainsi la liquidité jusqu'à mi-2026.
4. Fin du deuxième trimestre avec 431,5 millions de dollars en liquidités et équivalents.
5. Les dépenses de recherche et développement ont augmenté à 29,4 millions de dollars, contre 26,4 millions de dollars au deuxième trimestre 2023.
6. Les dépenses générales et administratives ont légèrement augmenté à 13,7 millions de dollars, contre 13,5 millions de dollars au deuxième trimestre 2023.
7. La perte nette avant intérêts minoritaires s'est élevée à 38,5 millions de dollars, contre 34,8 millions de dollars au deuxième trimestre 2023.
8. Nommer Carla Poulson au poste de Chief People Officer.
ProKidney Corp. (PROK) hat die finanziellen Ergebnisse und Geschäftsupdates für das zweite Quartal 2024 veröffentlicht. Die wichtigsten Highlights sind:
1. Präsentation von Zwischen-daten zu REGEN-007, die eine Stabilisierung der Nierenfunktion bei Diabetes- und fortgeschrittenen CKD-Patienten zeigen.
2. Wiederaufnahme der Produktion und Fortsetzung der Phase-3-Studien PROACT 1 und PROACT 2.
3. Abschluss eines ausgeweiteten öffentlichen Angebots in Höhe von 140 Millionen Dollar, wodurch die Liquidität bis Mitte 2026 verlängert wird.
4. Abschluss des zweiten Quartals mit 431,5 Millionen Dollar in Bar und Baräquivalenten.
5. Die F&E-Ausgaben stiegen auf 29,4 Millionen Dollar, gegenüber 26,4 Millionen Dollar im zweiten Quartal 2023.
6. Die allgemeinen und administrativen Aufwendungen stiegen leicht auf 13,7 Millionen Dollar, im Vergleich zu 13,5 Millionen Dollar im zweiten Quartal 2023.
7. Der Nettoverlust vor nicht beherrschenden Interessen betrug 38,5 Millionen Dollar, verglichen mit 34,8 Millionen Dollar im zweiten Quartal 2023.
8. Carla Poulson wurde zur Chief People Officer ernannt.
- Presented positive interim REGEN-007 data showing kidney function stabilization in patients
- Restarted manufacturing and resumed PROACT 1 and PROACT 2 Phase 3 trials
- Closed $140 million upsized public offering, extending cash runway into mid-2026
- Cash position increased to $431.5 million from $363.0 million at end of 2023
- Received QP Declaration of Equivalence to EU GMPs, allowing shipment of rilparencel to European clinical sites
- Net loss before noncontrolling interest increased to $38.5 million from $34.8 million in Q2 2023
- R&D expenses increased to $29.4 million from $26.4 million in Q2 2023
- G&A expenses slightly increased to $13.7 million from $13.5 million in Q2 2023
Insights
The interim results from REGEN-007 are encouraging for rilparencel's potential in preserving kidney function in advanced CKD patients with diabetes. The 18-month kidney function stabilization is a significant finding, given the progressive nature of CKD. However, it's important to note that these are interim data and the full Phase 2 results will be necessary to draw more definitive conclusions.
The resumption of PROACT 1 and PROACT 2 Phase 3 trials is a positive development, particularly with the amended protocol for PROACT 1 focusing on more advanced CKD patients. This enrichment strategy could potentially lead to more robust efficacy signals if rilparencel proves effective. The safety profile, described as consistent with prior studies and comparable to kidney biopsy, is reassuring but warrants continued vigilance in larger Phase 3 populations.
ProKidney's financial position has strengthened significantly with the
R&D expenses increased by
The restart of manufacturing and resumption of Phase 3 trials are critical milestones for ProKidney. The QP Declaration of Equivalence to EU GMPs is particularly significant, enabling the company to expand its clinical footprint in Europe. This international reach could be valuable for future commercialization efforts if rilparencel proves successful.
The appointment of Carla Poulson as Chief People Officer with her extensive experience in biotech HR is a strategic move. As ProKidney scales up operations, strong talent management will be crucial. The company's focus on addressing unmet needs in late-stage CKD patients positions it well in a growing market, given the increasing prevalence of diabetes and CKD globally. However, investors should remain cautious as success in Phase 3 trials is not guaranteed and the path to potential commercialization is still long.
- Reported interim REGEN-007 data that demonstrate rilparencel’s potential to preserve kidney function in patients with diabetes and advanced CKD
- Restarted manufacturing and resumed PROACT 1 and PROACT 2 Phase 3 trials
- Closed
$140 million upsized underwritten public offering and concurrent registered direct offering - Ended the second quarter with
$431.5 million in cash and cash equivalents and marketable securities, supporting operations through projected Phase 3 enrollment completion in mid-2026
WINSTON-SALEM, N.C., Aug. 09, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today reported business updates and financial results for the second quarter ended June 30, 2024.
“The interim results of REGEN-007 as presented in June support rilparencel’s potential to preserve kidney function in patients with diabetes and advanced CKD,” said Bruce Culleton, M.D., Chief Executive Officer. “In addition to positive clinical data, the second quarter marked several critical milestones. Manufacturing has restarted, both Phase 3 studies have resumed, and we completed a
Clinical, Corporate, and Operational Updates
- In June, we presented interim Phase 2 REGEN-007 data that showed kidney function stabilization for 18 months in patients with diabetes and advanced CKD who received rilparencel and a safety profile consistent with prior studies and comparable to kidney biopsy
- Manufacturing restarted in June and the QP Declaration of Equivalence to EU GMPs was received in July, allowing ProKidney to ship rilparencel to clinical study sites in Europe
- PROACT 1 and PROACT 2 Phase 3 trials resumed; patients have begun enrolling in PROACT 1 under the amended protocol that enriches for more advanced CKD patients
- Announced closing of an upsized
$140 million underwritten public offering and concurrent registered direct offering in June, extending cash runway into mid-2026 and through the expected full enrollment of the Phase 3 studies - Appointed Carla Poulson as Chief People Officer in May. Ms. Poulson brings approximately 25 years of experience in human resources, talent acquisition, and management development. Prior to ProKidney, Ms. Poulson served as Chief People Officer at UniQure Therapeutics, Mersana Therapeutics, Akcea Therapeutics and 10 years in senior HR leadership positions at Vertex Pharmaceuticals
Second Quarter 2024 Financial Highlights
Liquidity: Cash, cash equivalents and marketable securities as of June 30, 2024, totaled
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 June 30, 2024, totaled 289,674,830.
About ProKidney Corp.
ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney’s lead product candidate, rilparencel (also known as REACT®), is a first-of-its-kind, patented, proprietary autologous cellular therapy being evaluated to potentially preserve kidney function in patients with diabetes and advanced CKD. Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as FDA and EMA guidance, supporting its ongoing Phase 3 clinical program.
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 Securities and Exchange Commission. The Company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
Investor Contacts:
ProKidney
Ethan Holdaway
Ethan.Holdaway@prokidney.com
LifeSci Advisors, LLC
Daniel Ferry
Daniel@lifesciadvisors.com
| ProKidney Corp. and Subsidiaries Consolidated Balance Sheets (in thousands, except for share data) | |||||||
| June 30, 2024 | December 31, 2023 | ||||||
| (Unaudited) | |||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 214,508 | $ | 60,649 | |||
| Marketable securities | 217,023 | 302,301 | |||||
| Interest receivable | 2,748 | 1,375 | |||||
| Prepaid assets | 3,532 | 3,399 | |||||
| Prepaid clinical | 12,451 | 6,413 | |||||
| Other current assets | — | 9 | |||||
| Total current assets | 450,262 | 374,146 | |||||
| Fixed assets, net | 42,567 | 42,143 | |||||
| Right of use assets, net | 6,334 | 4,263 | |||||
| Total assets | $ | 499,163 | $ | 420,552 | |||
| Liabilities and Shareholders' Deficit | |||||||
| Accounts payable | $ | 2,933 | $ | 5,098 | |||
| Lease liabilities | 1,032 | 803 | |||||
| Accrued expenses and other | 15,109 | 17,665 | |||||
| Income taxes payable | 1,515 | 1,472 | |||||
| Total current liabilities | 20,589 | 25,038 | |||||
| Income tax payable, net of current portion | 568 | 568 | |||||
| Lease liabilities, net of current portion | 5,640 | 3,610 | |||||
| Total liabilities | 26,797 | 29,216 | |||||
| Commitments and contingencies | |||||||
| Redeemable noncontrolling interest | 1,444,737 | 1,494,732 | |||||
| Shareholders’ deficit | |||||||
| Class A ordinary shares, authorized; 125,856,877 and 59,880,347 issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 13 | 6 | |||||
| Class B ordinary shares, authorized; 163,817,953 and 168,297,916 issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 16 | 17 | |||||
| Additional paid-in capital | 189,267 | 36,114 | |||||
| Accumulated other comprehensive (loss) gain | (6 | ) | 130 | ||||
| Accumulated deficit | (1,161,661 | ) | (1,139,663 | ) | |||
| Total shareholders' deficit | (972,371 | ) | (1,103,396 | ) | |||
| Total liabilities and shareholders' deficit | $ | 499,163 | $ | 420,552 | |||
| ProKidney Corp. and Subsidiaries Consolidated Statements of Operations and Comprehensive Loss (in thousands, except for share and per share data) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 29,404 | $ | 26,364 | $ | 56,637 | $ | 51,981 | ||||||||
| General and administrative | 13,652 | 13,455 | 26,495 | 28,714 | ||||||||||||
| Total operating expenses | 43,056 | 39,819 | 83,132 | 80,695 | ||||||||||||
| Operating loss | (43,056 | ) | (39,819 | ) | (83,132 | ) | (80,695 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 4,537 | 5,965 | 9,380 | 11,262 | ||||||||||||
| Interest expense | (3 | ) | (4 | ) | (5 | ) | (7 | ) | ||||||||
| Net loss before income taxes | (38,522 | ) | (33,858 | ) | (73,757 | ) | (69,440 | ) | ||||||||
| Income tax (benefit) expense | (56 | ) | 965 | 42 | 2,292 | |||||||||||
| Net loss before noncontrolling interest | (38,466 | ) | (34,823 | ) | (73,799 | ) | (71,732 | ) | ||||||||
| Net loss attributable to noncontrolling interest | (25,960 | ) | (25,705 | ) | (51,801 | ) | (52,949 | ) | ||||||||
| Net loss available to Class A ordinary shareholders | $ | (12,506 | ) | $ | (9,118 | ) | $ | (21,998 | ) | $ | (18,783 | ) | ||||
| Weighted average Class A ordinary shares outstanding: | ||||||||||||||||
| Basic and diluted | 75,908,017 | 64,562,209 | 68,429,869 | 64,551,281 | ||||||||||||
| Net loss per share attributable to Class A ordinary shares: | ||||||||||||||||
| Basic and diluted | $ | (0.16 | ) | $ | (0.14 | ) | $ | (0.32 | ) | $ | (0.29 | ) | ||||
| ProKidney Corp. and Subsidiaries Consolidated Statements of Cash Flows (in thousands) | |||||||||||
| Six Months Ended June 30, | |||||||||||
| 2024 | 2023 | ||||||||||
| Cash flows from operating activities | |||||||||||
| Net loss before noncontrolling interest | $ | (73,799 | ) | $ | (71,732 | ) | |||||
| Adjustments to reconcile net loss before noncontrolling interest to net cash flows used in operating activities: | |||||||||||
| Depreciation and amortization | 2,372 | 1,702 | |||||||||
| Equity-based compensation | 15,489 | 24,222 | |||||||||
| Gain on marketable securities, net | (3,802 | ) | (1,981 | ) | |||||||
| Loss on disposal of equipment | 131 | 3 | |||||||||
| Changes in operating assets and liabilities | |||||||||||
| Interest receivable | (1,373 | ) | (8,090 | ) | |||||||
| Prepaid and other assets | (6,162 | ) | 2,256 | ||||||||
| Accounts payable and accrued expenses | (5,838 | ) | 12,430 | ||||||||
| Income taxes payable | 43 | 282 | |||||||||
| Net cash flows used in operating activities | (72,939 | ) | (40,908 | ) | |||||||
| Cash flows from investing activities | |||||||||||
| Purchases of marketable securities | (82,880 | ) | (261,847 | ) | |||||||
| Sales and maturities of marketable securities | 171,445 | 60,768 | |||||||||
| Purchase of equipment and facility expansion | (1,596 | ) | (4,686 | ) | |||||||
| Net cash flows provided by (used in) investing activities | 86,969 | (205,765 | ) | ||||||||
| Cash flows from financing activities | |||||||||||
| Proceeds from sales of Class A ordinary shares, net of offering costs | 139,855 | – | |||||||||
| Payments on finance leases | (26 | ) | (26 | ) | |||||||
| Net cash flows provided by (used in) financing activities | 139,829 | (26 | ) | ||||||||
| Net change in cash and cash equivalents | 153,859 | (246,699 | ) | ||||||||
| Cash, beginning of period | 60,649 | 490,252 | |||||||||
| Cash, end of period | $ | 214,508 | $ | 243,553 | |||||||
| Supplemental disclosure of non-cash investing and financing activities: | |||||||||||
| Right of use assets obtained in exchange for lease obligations | $ | 2,621 | $ | 714 | |||||||
| Exchange of Class B ordinary shares | $ | 14,902 | $ | – | |||||||
| Impact of equity transactions and compensation on redeemable noncontrolling interest | $ | 16,708 | $ | 380 | |||||||
| Change in redemption value of noncontrolling interest | $ | – | $ | 230,209 | |||||||
| Equipment and facility expansion included in accounts payable and accrued expenses | $ | 780 | $ | 689 | |||||||
FAQ
What were ProKidney's (PROK) key financial results for Q2 2024?
What clinical updates did ProKidney (PROK) report in Q2 2024?
How much did ProKidney (PROK) raise in its public offering in Q2 2024?
What is ProKidney's (PROK) cash runway following the Q2 2024 results?
Who did ProKidney (PROK) appoint as Chief People Officer in Q2 2024?
