Processa Pharmaceuticals Reports Third Quarter Business Highlights and Financial Results
Processa Pharmaceuticals reports progress in its oncology pipeline and Q3 2024 financial results. The company has dosed its first patient in a Phase 2 trial of NGC-Cap for metastatic breast cancer, with interim data expected in H2 2025. Preclinical studies for NGC-Iri showed improved tumor targeting compared to irinotecan and Onivyde®. Financial highlights include R&D expenses of $2.3M (up from $1.2M in Q3 2023), G&A expenses of $1.1M, and a net loss of $3.4M ($1.03 per share). Cash position stands at $2.9M as of September 30, 2024.
Processa Pharmaceuticals riporta progressi nel suo pipeline oncologico e i risultati finanziari del Q3 2024. L'azienda ha somministrato il primo trattamento al paziente in una sperimentazione di Fase 2 di NGC-Cap per il cancro al seno metastatico, con dati preliminari attesi per la seconda metà del 2025. Gli studi preclinici per NGC-Iri hanno mostrato un targeting tumorale migliorato rispetto all'irinotecan e all'Onivyde®. I punti salienti finanziari includono spese per R&S di $2.3M (in aumento rispetto a $1.2M nel Q3 2023), spese generali e amministrative di $1.1M, e una perdita netta di $3.4M ($1.03 per azione). La posizione di cassa è di $2.9M al 30 settembre 2024.
Processa Pharmaceuticals informa sobre los avances en su pipeline de oncología y los resultados financieros del tercer trimestre de 2024. La compañía ha tratado a su primer paciente en un ensayo de Fase 2 de NGC-Cap para el cáncer de mama metastásico, con datos intermedios esperados para la segunda mitad de 2025. Los estudios preclínicos de NGC-Iri mostraron una mejor capacidad de localización del tumor en comparación con el irinotecán y Onivyde®. Los aspectos destacados financieros incluyen gastos de I+D de $2.3M (aumento desde $1.2M en el Q3 2023), gastos generales y administrativos de $1.1M, y una pérdida neta de $3.4M ($1.03 por acción). La posición de efectivo se sitúa en $2.9M a partir del 30 de septiembre de 2024.
Processa Pharmaceuticals는 자사의 악성 종양 개발 및 2024년 3분기 재무 결과에 대한 진행 상황을 보고합니다. 이 회사는 전이성 유방암을 위한 NGC-Cap의 2상 시험에서 첫 번째 환자에게 약물을 투여하였으며, 2025년 하반기에는 중간 데이터가 예상됩니다. NGC-Iri의 전임상 연구는 이리노테칸 및 Onivyde®에 비해 종양 타겟팅이 향상된 결과를 보여주었습니다. 재무 하이라이트로는 R&D 비용이 $2.3M(2023년 3분기 $1.2M에서 증가)이고, G&A 비용이 $1.1M, 순손실이 $3.4M($1.03 per share)입니다. 현금 보유액은 2024년 9월 30일 기준으로 $2.9M입니다.
Processa Pharmaceuticals fait état des progrès réalisés dans son portefeuille oncologique et des résultats financiers du troisième trimestre 2024. L'entreprise a administré son premier traitement à un patient dans le cadre d'un essai de Phase 2 de NGC-Cap pour le cancer du sein métastatique, avec des données intermédiaires attendues pour le second semestre 2025. Les études précliniques de NGC-Iri ont montré un ciblage tumoral amélioré par rapport à l'irinotécan et à l'Onivyde®. Les points forts financiers incluent des dépenses de R&D de 2,3 millions de dollars (en hausse par rapport à 1,2 million de dollars au troisième trimestre 2023), des dépenses générales et administratives de 1,1 million de dollars, et une perte nette de 3,4 millions de dollars (1,03 dollar par action). La position de trésorerie s'élève à 2,9 millions de dollars au 30 septembre 2024.
Processa Pharmaceuticals berichtet über Fortschritte in seiner Onkologie-Pipeline und die finanziellen Ergebnisse für das dritte Quartal 2024. Das Unternehmen hat seinen ersten Patienten in einer Phase-2-Studie zu NGC-Cap bei metastasiertem Brustkrebs behandelt, wobei interimistische Daten für die zweite Hälfte des Jahres 2025 erwartet werden. Präklinische Studien zu NGC-Iri zeigten eine verbesserte Tumoransprache im Vergleich zu Irinotecan und Onivyde®. Die finanziellen Highlights umfassen F&E-Aufwendungen von 2,3 Millionen US-Dollar (ein Anstieg von 1,2 Millionen US-Dollar im dritten Quartal 2023), G&A-Aufwendungen von 1,1 Millionen US-Dollar und einen Nettoverlust von 3,4 Millionen US-Dollar (1,03 US-Dollar pro Aktie). Zum 30. September 2024 beläuft sich die Liquidität auf 2,9 Millionen US-Dollar.
- First patient dosed in Phase 2 trial for NGC-Cap in metastatic breast cancer
- Preclinical studies show NGC-Iri's superior tumor targeting compared to existing treatments
- Net loss increased to $3.4M from $2.1M year-over-year
- R&D expenses nearly doubled to $2.3M from $1.2M year-over-year
- cash position of $2.9M may require additional funding
Insights
The financial position shows concerning trends with
Key catalysts are distant, with NGC-Cap interim data not expected until H2 2025. While the pipeline shows promise, particularly NGC-Iri's preclinical advantages over existing treatments, the company's financial constraints may force dilutive financing before reaching value-driving milestones.
The company's strategy of improving existing chemotherapies through enhanced drug metabolism and distribution is scientifically sound. NGC-Cap's Phase 2 trial design aligns well with FDA's Project Optimus initiative by evaluating multiple doses to optimize the benefit-risk profile. The NGC-Iri preclinical data showing higher tumor-specific SN-38 accumulation suggests potential for improved efficacy and reduced toxicity compared to standard irinotecan.
However, the development timeline appears extended, with key clinical readouts over a year away. The concurrent development of three programs may strain resources and the lack of clear prioritization between indications could impact efficient capital allocation. The absence of earlier clinical validation data adds significant risk to the platform approach.
First patient dosed in Phase 2 clinical trial with NGC-Cap for metastatic breast cancer
Positive data from preclinical studies support NGC-Iri’s ability to deliver more SN-38 to tumors compared with either irinotecan or Onivyde®
HANOVER, Md., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, provides updates on its product pipeline, upcoming milestones and business activities, and reports financial results for the three and nine months ended September 30, 2024.
“We continued to make progress with our programs as we further demonstrate the potential benefits of our oncology therapeutics,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “Our NGC-Cap Phase 2 clinical trial in metastatic breast cancer is underway with the first patient dosed. As this is an open-label trial, we anticipate sharing initial data in the second half of 2025. Additionally, we reported positive findings from preclinical studies that support NGC-Iri’s potential for improved efficacy and a superior side effect profile compared with the commonly used FDA-approved chemotherapy drugs irinotecan and Onivyde®. We are pleased with our progress and remain committed to improving the lives of people with cancer.”
Key Program Updates
Processa is focused on developing next-generation chemotherapies (NGC) by improving widely used U.S. Food and Drug Administration (FDA)-approved drugs to extend cancer patients’ survival and/or improve their quality of life. This is achieved by altering how drugs are metabolized and/or distributed in the body, including how they reach cancer cells. In addition, Processa utilizes its Regulatory Science Approach, including the principles associated with FDA’s Project Optimus Oncology initiative, in the development of its NGC drug products to achieve a more favorable benefit-risk profile.
- PCS6422: Next-Generation Capecitabine (NGC-Cap)
- NGC-Cap is a combination of PCS6422 and capecitabine, which is the oral prodrug of the cancer drug 5-fluorouracil (5-FU). PCS6422 alters the metabolism of 5-FU, resulting in more 5-FU distributed to cancer cells.
- Earlier this month, the first patient was dosed in a Phase 2 clinical trial (NCT06568692) evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer. The Phase 2 study is a global, multicenter, open-label, adaptive-design trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in approximately 60 to 90 patients. The trial is designed to evaluate the safety-efficacy profile of NGC-Cap versus monotherapy capecitabine, to determine the potential optimal dosage regimens of NGC-Cap as required by the FDA Project Optimus Initiative and to evaluate the possibility of personalizing NGC-Cap therapy. The Company expects to announce interim data from this trial in the second half of 2025.
- PCS3117: Next-Generation Gemcitabine (NGC-Gem)
- NGC-Gem is an oral analog of gemcitabine (Gemzar®) that is converted to its active metabolite by a different enzyme system, with potential for a positive response in gemcitabine patients including those inherently resistant to or who acquire resistance to gemcitabine.
- Processa is evaluating the potential of NGC-Gem in patients with pancreatic and other cancers, as well as ways to identify patients who are more likely to respond to NGC-Gem than gemcitabine alone. The Company is requesting a meeting with the FDA to discuss potential trial designs, including implementation of the Project Optimus initiative.
- PCS11T: Next-Generation Irinotecan (NGC-Iri)
- NGC-Iri is an analog of SN-38, the active metabolite of irinotecan, that is expected to have an improved safety-efficacy profile in every type of cancer where irinotecan is currently used.
- As announced in August, two studies in a human melanoma xenograft mouse model measured SN-38 in tumors, plasma and other tissues following administration of NGC-Iri, irinotecan and Onivyde®, the liposomal formulation of irinotecan. One study compared NGC-Iri with irinotecan, and the other compared irinotecan with Onivyde®. The results found that mice administered NGC-Iri had greater accumulation of SN-38 in the tumor compared with other tissues and that less SN-38 accumulated in non-cancer tissues, which could lead to improved efficacy with a more favorable adverse event profile compared with irinotecan and Onivyde®.
- The Company is currently evaluating the manufacturing process and potential sites for NGC-Iri. In addition, Processa is defining the potential paths to approval, which includes defining the target patient population and the type of cancer, and expects to conduct IND-enabling toxicology studies in 2025.
Third Quarter Financial Results
Research and development expenses for the third quarter of 2024 were
The net loss for the third quarter of 2024 was
Cash and cash equivalents were
About Processa Pharmaceuticals, Inc.
Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Chemotherapy (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path.
For more information, visit our website at www.processapharma.com.
Forward-Looking Statements
This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.
Company Contact:
Patrick Lin
(925) 683-3218
plin@processapharma.com
Investor Relations Contact:
Yvonne Briggs
Alliance Advisors Investor Relations
(310) 691-7100
ybriggs@allianceadvisorsir.com
[Financial Tables to follow]
PROCESSA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share information)
(unaudited)
| September 30, 2024 | December 31, 2023 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 2,891 | $ | 4,706 | ||||
| Prepaid expenses and other | 1,947 | 926 | ||||||
| Total Current Assets | 4,838 | 5,632 | ||||||
| Property and Equipment, net | 5 | 3 | ||||||
| Other Assets | ||||||||
| Lease right-of-use assets, net of accumulated amortization | 93 | 146 | ||||||
| Security deposit | 6 | 6 | ||||||
| Total Other Assets | 99 | 152 | ||||||
| Total Assets | $ | 4,942 | $ | 5,787 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current Liabilities | ||||||||
| Current maturities of lease liabilities | $ | 94 | $ | 84 | ||||
| Accounts payable | 712 | 312 | ||||||
| Due to licensor | - | 189 | ||||||
| Due to related parties | - | - | ||||||
| Accrued expenses | 413 | 146 | ||||||
| Total Current Liabilities | 1,219 | 731 | ||||||
| Non-current Liabilities | ||||||||
| Non-current lease liabilities | 2 | 67 | ||||||
| Total Liabilities | 1,221 | 798 | ||||||
| Commitments and Contingencies | - | - | ||||||
| Stockholders’ Equity | ||||||||
| Common stock, par value | - | - | ||||||
| Additional paid-in capital | 88,511 | 80,658 | ||||||
| Treasury stock at cost — 5,000 shares at September 30, 2024 and December 31, 2023 | (300 | ) | (300 | ) | ||||
| Accumulated deficit | (84,490 | ) | (75,369 | ) | ||||
| Total Stockholders’ Equity | 3,721 | 4,989 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 4,942 | $ | 5,787 | ||||
PROCESSA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating Expenses | ||||||||||||||||
| Research and development | $ | 2,288 | $ | 1,152 | $ | 5,557 | $ | 4,479 | ||||||||
| General and administrative | 1,137 | 1,016 | 3,760 | 4,509 | ||||||||||||
| Operating Loss | (3,425 | ) | (2,168 | ) | (9,317 | ) | (8,988 | ) | ||||||||
| Other Income (Expense) | ||||||||||||||||
| Interest income, net | 40 | 86 | 195 | 271 | ||||||||||||
| Net Loss | $ | (3,385 | ) | $ | (2,082 | ) | $ | (9,122 | ) | $ | (8,717 | ) | ||||
| Net Loss per Common Share - Basic and Diluted | $ | (1.03 | ) | $ | (1.54 | ) | $ | (3.13 | ) | $ | (6.81 | ) | ||||
| Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Basic and Diluted | 3,275,998 | 1,350,188 | 2,909,941 | 1,279,298 | ||||||||||||
# # #
FAQ
When will Processa Pharmaceuticals (PCSA) release interim data for NGC-Cap Phase 2 trial?
What were Processa Pharmaceuticals' (PCSA) Q3 2024 financial results?
What is the status of NGC-Iri development at Processa Pharmaceuticals (PCSA)?
