Corbus Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides a Corporate Update
Corbus Pharmaceuticals (NASDAQ: CRBP) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. CRB-701: Encouraging Phase 1 data presented at ASCO 2024, showing 44% ORR in metastatic urothelial cancer and 43% ORR in cervical cancer. Phase 1 dose escalation underway in USA and Europe.
2. CRB-913: Phase 1 study for obesity treatment expected to commence in Q1 2025.
3. CRB-601: FDA cleared IND, Phase 1 study expected to initiate in Q4 2024.
4. Financial Results: Net loss of $10.0 million for Q2 2024. Cash, cash equivalents, and investments of $147 million as of June 30, 2024, expected to fund operations through Q3 2027.
Corbus Pharmaceuticals (NASDAQ: CRBP) ha riportato i risultati finanziari del secondo trimestre 2024 e fornito un aggiornamento aziendale. I punti salienti includono:
1. CRB-701: Dati promettenti della Fase 1 presentati all'ASCO 2024, con un tasso di risposta obiettiva del 44% nel cancro uroteliale metastatico e del 43% nel cancro cervicale. È in corso l'escalation della dose nella Fase 1 negli Stati Uniti e in Europa.
2. CRB-913: Si prevede che lo studio di Fase 1 per il trattamento dell'obesità inizi nel primo trimestre del 2025.
3. CRB-601: L'FDA ha approvato l'IND, e si prevede che lo studio di Fase 1 inizi nel quarto trimestre del 2024.
4. Risultati finanziari: Per il secondo trimestre del 2024 si è registrata una perdita netta di 10,0 milioni di dollari. Le disponibilità liquide, equivalenti e investimenti ammontano a 147 milioni di dollari al 30 giugno 2024, e si prevede che finanzino l'operatività fino al terzo trimestre del 2027.
Corbus Pharmaceuticals (NASDAQ: CRBP) reportó los resultados financieros del segundo trimestre de 2024 y brindó una actualización corporativa. Los aspectos destacados incluyen:
1. CRB-701: Datos alentadores de la Fase 1 presentados en ASCO 2024, mostrando un 44% de Tasa de Respuesta Objetiva en cáncer urotelial metastásico y un 43% en cáncer cervical. Se está llevando a cabo la escalada de dosis en la Fase 1 en EE. UU. y Europa.
2. CRB-913: Se espera que el estudio de Fase 1 para el tratamiento de la obesidad comience en el primer trimestre de 2025.
3. CRB-601: La FDA aprobó el IND, y se espera que el estudio de Fase 1 inicie en el cuarto trimestre de 2024.
4. Resultados financieros: Pérdida neta de 10,0 millones de dólares para el segundo trimestre de 2024. El efectivo, equivalentes de efectivo e inversiones alcanzan los 147 millones de dólares al 30 de junio de 2024, y se espera que financien las operaciones hasta el tercer trimestre de 2027.
Corbus Pharmaceuticals (NASDAQ: CRBP)는 2024년 2분기 재무 결과를 발표하고 기업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. CRB-701: 2024년 ASCO에서 발표된 1상 데이터가 고무적이며, 전이성 요로상피암에서 44%의 객관적 반응률(ORR)과 자궁경부암에서 43%의 ORR을 보였습니다. 미국과 유럽에서 1상 용량 증량이 진행 중입니다.
2. CRB-913: 비만 치료를 위한 1상 연구가 2025년 1분기에 시작될 예정입니다.
3. CRB-601: FDA에서 IND가 승인되었으며, 1상 연구가 2024년 4분기에 시작될 것으로 예상됩니다.
4. 재무 결과: 2024년 2분기 순손실이 1천만 달러로 나타났습니다. 2024년 6월 30일 기준 현금, 현금성 자산 및 투자액이 1억 4천7백만 달러에 달하며, 2027년 3분기까지 운영 자금을 지원할 것으로 예상됩니다.
Corbus Pharmaceuticals (NASDAQ: CRBP) a annoncé les résultats financiers du deuxième trimestre 2024 et fourni une mise à jour de l'entreprise. Les points clés comprennent :
1. CRB-701: Des données encourageantes de la Phase 1 présentées à l'ASCO 2024, montrant un taux de réponse objective de 44 % dans le cancer urotélial métastatique et de 43 % dans le cancer du col de l'utérus. L'escalade de la dose de la Phase 1 est en cours aux États-Unis et en Europe.
2. CRB-913: L'étude de Phase 1 pour le traitement de l'obésité devrait commencer au premier trimestre 2025.
3. CRB-601: L'IND a été approuvé par la FDA, et l'étude de Phase 1 devrait commencer au quatrième trimestre 2024.
4. Résultats financiers: Une perte nette de 10,0 millions de dollars pour le deuxième trimestre 2024. La trésorerie, les équivalents de trésorerie et les investissements s'élèvent à 147 millions de dollars au 30 juin 2024, et il est prévu qu'ils financent les opérations jusqu'au troisième trimestre 2027.
Corbus Pharmaceuticals (NASDAQ: CRBP) hat die finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und ein Unternehmensupdate gegeben. Die wichtigsten Highlights umfassen:
1. CRB-701: Ermutigende Phase-1-Daten wurden auf der ASCO 2024 vorgestellt, die eine objektive Ansprechrate (ORR) von 44% bei metastasierendem Urothelkarzinom und 43% bei Zervixkarzinom zeigen. Phase-1-Dosiserhöhung läuft in den USA und Europa.
2. CRB-913: Die Phase-1-Studie zur Behandlung von Fettleibigkeit soll im ersten Quartal 2025 beginnen.
3. CRB-601: FDA genehmigte IND, Phase-1-Studie soll im vierten Quartal 2024 beginnen.
4. Finanzergebnisse: Ein Nettoverlust von 10,0 Millionen Dollar für das zweite Quartal 2024. Bargeld, Bargeldäquivalente und Investitionen in Höhe von 147 Millionen Dollar zum 30. Juni 2024, die voraussichtlich den Betrieb bis zum dritten Quartal 2027 finanzieren.
- CRB-701 showed 44% ORR in metastatic urothelial cancer and 43% ORR in cervical cancer
- Phase 1 dose escalation for CRB-701 underway in USA and Europe
- FDA cleared IND for CRB-601
- $147 million in cash, cash equivalents, and investments as of June 30, 2024
- Cash runway extended through Q3 2027
- Raised $35.6 million net proceeds through ATM program in Q2 2024
- Net loss increased to $10.0 million in Q2 2024 from $8.8 million in Q2 2023
- Operating expenses increased by $2.8 million to $11.0 million in Q2 2024
Insights
Corbus Pharmaceuticals' Q2 2024 results reveal a mixed financial picture. The company reported a net loss of
However, the company's cash position is robust, with
The clinical update for CRB-701 presented at ASCO 2024 shows promising results in metastatic urothelial cancer (mUC) and cervical cancer. With an overall response rate (ORR) of
Importantly, the safety profile appears favorable, with no dose-limiting toxicities observed up to 4.5 mg/Kg. The low incidence of skin rash and peripheral neuropathy is particularly noteworthy, as these are common issues with similar drugs. The lower levels of free MMAE compared to enfortumab vedotin could potentially translate to improved tolerability in clinical practice.
Corbus' pipeline is advancing steadily. The CRB-701 Phase 1 dose escalation study is on track for completion in Q4 2024, with data presentation expected in Q1 2025. This timeline suggests efficient progress and could provide valuable insights for future development.
CRB-913, targeting obesity, shows promising preclinical results, particularly in combination with incretin analogs. The planned Phase 1 study initiation in Q1 2025 indicates a strategic approach to addressing the lucrative obesity market. For CRB-601, the FDA's IND clearance and planned Phase 1 study initiation in Q4 2024 demonstrate continued pipeline momentum. These advancements across multiple candidates reflect a diversified and progressing portfolio, potentially mitigating risk and enhancing long-term value prospects.
- Clinical update presented at ASCO 2024 for CRB-701 showed continued differentiated safety and encouraging efficacy in patients with metastatic urothelial cancer or cervical cancer
- CRB-701 Phase 1 dose escalation underway in USA and Europe for patients with metastatic urothelial cancer and other nectin-4 enriched tumors and is on schedule for completion in Q4 2024
- Cash runway extended through Q3 2027 with
$147 million of cash & investments at June 30, 2024
NORWOOD, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), today provided a corporate update and reported financial results for the quarter ended June 30, 2024.
“We continue to make progress across our pipeline,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “Updated clinical data was presented at ASCO 2024 by our development partner CSPC for CRB-701 (SYS6002). The data provided further evidence of the differentiated safety and encouraging efficacy first presented at ASCO GU in January 2024. This larger dataset of patients increases our confidence that CRB-701 is clinically active. The emerging safety data was reassuring showing low rates of skin rash and peripheral neuropathy and rare grade 3 adverse events. During the quarter, we commenced dose escalation in our corresponding U.S. and European Phase 1 clinical trial of CRB-701, a significant milestone that builds on this promising data. Separately, we expect to dose the first patient in Q1 2025 for CRB-913, our highly peripherally restricted oral CB1 inverse agonist. We look forward to continuing to advance our programs across our pipeline over the course of this year,” concluded Dr. Cohen.
Key Corporate Updates
CRB-701:
- Encouraging additional data from Phase 1 study presented at ASCO in June 2024:
- Results demonstrated
44% ORR and78% DCR in metastatic urothelial cancer (“mUC”) and43% ORR and86% DCR in cervical cancer to date at doses ≥ 1.2mg/Kg - No dose limiting toxicities (“DLTs”) have been observed to date in doses up to and including 4.5 mg/Kg
- Three cases of skin rash (including one grade 3) and one case of grade 1 neuropathy seen to date; all were resolved
- Early pharmacokinetics (“PK”) data demonstrate consistently lower levels of free MMAE than enfortumab vedotin across all doses in the study, including 4.5 mg/Kg
- Results demonstrated
- Dose escalation commenced in the Phase 1 clinical trial of CRB-701-01 in April 2024. The Phase 1 portion of the open label study design (NCT06265727), being conducted in the U.S. and Europe, will evaluate the safety, efficacy and PK of CRB-701 in participants with advanced solid tumors associated with high nectin-4 expression. The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose. The Company expects to complete the dose escalation phase in Q4 2024 and present the USA dose escalation data in Q1 2025.
CRB-913:
- CRB-913 is a second-generation highly peripherally restricted CB1 receptor inverse agonist designed to treat obesity. In a diet-induced obesity ("DIO") mouse model, CRB-913, as a monotherapy and in combination with incretin analogs (tirzepatide, semaglutide, or liraglutide), demonstrated a reduction in body weight in DIO mice and improvements were observed in body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits, and liver histology.
- The Company expects to commence a Phase 1 study in the first quarter of 2025.
CRB-601:
- CRB-601 is a high affinity and selective anti-αvβ8 monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells in the tumor microenvironment. In pre-clinical models, CRB-601 demonstrates enhanced anti-tumor activity when combined with anti-PD-1 checkpoint inhibitor therapy compared to either single agent alone.
- In January 2024, the FDA cleared the IND for CRB-601, and the Company expects to initiate a Phase 1 study of CRB-601 in Q4 2024.
Financial Results for Quarter Ended June 30, 2024:
The Company reported a net loss of approximately
Operating expenses increased by
The Company reported cash, cash equivalents and investments of
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate that targets the expression of nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.
INVESTOR CONTACT:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
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| Corbus Pharmaceuticals Holdings, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (Unaudited) | ||||||||||||||||
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 6,865 | $ | 4,249 | $ | 12,627 | $ | 17,637 | ||||||||
| General and administrative | 4,123 | 3,940 | 7,984 | 7,849 | ||||||||||||
| Total operating expenses | 10,988 | 8,189 | 20,611 | 25,486 | ||||||||||||
| Operating loss | (10,988 | ) | (8,189 | ) | (20,611 | ) | (25,486 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Other income, net | 695 | 183 | 3,604 | 412 | ||||||||||||
| Interest income | 906 | 232 | 1,568 | 494 | ||||||||||||
| Interest expense | (652 | ) | (1,008 | ) | (1,491 | ) | (1,948 | ) | ||||||||
| Change in fair value of derivative liability | 11 | — | 39 | — | ||||||||||||
| Foreign currency transaction (loss) gain, net | 31 | (2 | ) | (5 | ) | (1 | ) | |||||||||
| Other income (expense), net | 991 | (595 | ) | 3,715 | (1,043 | ) | ||||||||||
| Net loss | $ | (9,997 | ) | $ | (8,784 | ) | $ | (16,896 | ) | $ | (26,529 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.90 | ) | $ | (2.05 | ) | $ | (1.75 | ) | $ | (6.27 | ) | ||||
| Weighted average number of common shares outstanding, basic and diluted | 11,053,241 | 4,277,701 | 9,681,875 | 4,229,894 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (9,997 | ) | $ | (8,784 | ) | $ | (16,896 | ) | $ | (26,529 | ) | ||||
| Other comprehensive (loss) income: | ||||||||||||||||
| Change in unrealized (loss) gain on marketable debt securities | (59 | ) | 45 | (387 | ) | 103 | ||||||||||
| Total other comprehensive (loss) income | (59 | ) | 45 | (387 | ) | 103 | ||||||||||
| Total comprehensive loss | $ | (10,056 | ) | $ | (8,739 | ) | $ | (17,283 | ) | $ | (26,426 | ) | ||||
| Corbus Pharmaceuticals Holdings, Inc. Condensed Consolidated Balance Sheets (in thousands, except share and per share amounts) | ||||||||
| June 30, 2024 (Unaudited) | December 31, 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 23,686 | $ | 13,724 | ||||
| Investments | 123,339 | 7,182 | ||||||
| Restricted cash | 285 | 192 | ||||||
| Prepaid expenses and other current assets | 1,001 | 2,448 | ||||||
| Total current assets | 148,311 | 23,546 | ||||||
| Restricted cash | 385 | 478 | ||||||
| Property and equipment, net | 671 | 973 | ||||||
| Operating lease right-of-use assets | 2,612 | 3,063 | ||||||
| Other assets | — | 212 | ||||||
| Total assets | $ | 151,979 | $ | 28,272 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Notes payable | $ | 77 | $ | 301 | ||||
| Accounts payable | 1,152 | 3,179 | ||||||
| Accrued expenses | 10,488 | 11,030 | ||||||
| Derivative liability | — | 39 | ||||||
| Operating lease liabilities, current | 1,519 | 1,437 | ||||||
| Loan payable | 10,744 | 15,908 | ||||||
| Total current liabilities | 23,980 | 31,894 | ||||||
| Other long-term liabilities | — | 44 | ||||||
| Operating lease liabilities, noncurrent | 2,456 | 3,239 | ||||||
| Total liabilities | 26,436 | 35,177 | ||||||
| Stockholders’ equity | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, 11,498,917 and 4,423,683 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 1 | — | ||||||
| Additional paid-in capital | 579,510 | 429,780 | ||||||
| Accumulated deficit | (453,580 | ) | (436,684 | ) | ||||
| Accumulated other comprehensive loss | (388 | ) | (1 | ) | ||||
| Total stockholders’ equity (deficit) | 125,543 | (6,905 | ) | |||||
| Total liabilities and stockholders’ equity | $ | 151,979 | $ | 28,272 | ||||
FAQ
What were Corbus Pharmaceuticals' (CRBP) Q2 2024 financial results?
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