RenovoRx Highlights Key Leadership Promotions
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Insights
From an oncological perspective, the promotion of Leesa Gentry to Chief Clinical Officer at RenovoRx is a strategic move that could have a significant impact on the company's clinical operations. The development of RenovoGemTM for the treatment of Locally Advanced Pancreatic Cancer (LAPC) is particularly noteworthy, as LAPC is a condition with limited treatment options and a poor prognosis. The TIGeR-PaC study's primary endpoint of a 6-month Overall Survival benefit is ambitious and if met, could represent a significant advancement in the standard of care. Ms. Gentry's prior success in achieving the first interim analysis and the continuation of the study underlines the potential of RenovoGemTM to meet a critical unmet medical need.
Moreover, the focus on reducing side effects compared to standard chemotherapy regimens is crucial in oncology, where treatment tolerability can greatly affect patient quality of life. Positive clinical trial results could lead to increased investor confidence and potentially expedite the drug's path to market, subject to regulatory approval. This would not only benefit patients but could also enhance RenovoRx's market position and financial stability.
The appointment of Ronald B. Kocak as Principal Accounting Officer holds financial implications for RenovoRx. His role in completing a $6.1 million private placement is indicative of his ability to secure funding necessary for the company's sustained research and development. The extension of the company's cash runway is a critical factor for investors, as it suggests a reduced risk of near-term cash shortfalls and the need for dilutive financing rounds.
Financial management and strategic planning are essential for a clinical-stage biopharmaceutical company, particularly one that is in the midst of a Phase III study. The costs associated with such studies are substantial and efficient financial oversight can make the difference between a successful program and one that is hampered by budget constraints. Mr. Kocak's expertise and experience in the life sciences industry could provide RenovoRx with an edge in managing its financial resources during a pivotal period in its clinical development.
The leadership changes at RenovoRx signal a commitment to growth and innovation, which is vital in the competitive biopharmaceutical landscape. The market for pancreatic cancer treatments is characterized by high unmet needs and the company's focus on a precision oncology therapy could position it well within this niche market. The success of RenovoGemTM in clinical trials could disrupt the current treatment paradigm and capture significant market share.
Understanding the competitive landscape, potential market size and the regulatory environment is essential for forecasting the commercial potential of RenovoGemTM. If the TIGeR-PaC study yields positive results, RenovoRx could leverage this to negotiate partnerships or licensing agreements, which would be lucrative for the company's long-term growth strategy. The market's response to these leadership changes and the progress of the clinical trials will be critical in assessing RenovoRx's future potential and the impact on its stock valuation.
Company has promoted Leesa Gentry to Chief Clinical Officer and Ronald B. Kocak to Principal Accounting Officer
Shaun Bagai, Chief Executive Officer of RenovoRx, commented, “We are delighted to promote Leesa and Ron to their new leadership roles, which reflects our commitment to assembling a dynamic team poised to continue to lead a successful clinical pathway for our proprietary therapy platform. We have streamlined our team, focusing our efforts on strategic initiatives to drive growth and innovation. On behalf of our Board of Directors, I extend our gratitude to Leesa and Ron on their hard work and dedication to date and congratulate them on their well-deserved promotions.”
Ms. Gentry has served as Senior Vice President of Clinical Operations at RenovoRx since April 2023. In her new role as Chief Clinical Officer, she will oversee clinical and regulatory operations ensuring the highest standards for safety and quality are met across RenovoRx clinical studies. Ms. Gentry will continue to implement her breadth of experience as the Company drives towards a second interim analysis for the Phase III TIGeR-PaC study evaluating RenovoRx’s lead product candidate, RenovoGemTM for the treatment of Locally Advanced Pancreatic Cancer (LAPC), which is expected by late 2024.
Since joining RenovoRx, Ms. Gentry has demonstrated exemplary leadership and commitment to advancing the Company’s clinical pipeline. In 2023, Ms. Gentry helped to achieve the first interim analysis in the TIGeR-PaC with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study’s primary endpoint is a 6-month Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. Under her guidance, the Company’s clinical strategy to date has yielded positive results that contribute to the Company’s commitment to improve patients’ lives and lifespans by delivering therapies that have the potential to revolutionize the current paradigm of cancer care.
Mr. Kocak has been promoted to the position of Principal Accounting Officer and will retain his roles as Vice President and Controller of RenovoRx. He joined the Company in October 2021 and is a seasoned financial reporting and accounting professional with extensive public and private company experience in the life sciences industry. Mr. Kocak was instrumental in the recent completion of a
About RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company developing proprietary targeted combination therapies for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. The Company’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic (intravenous (IV) therapy). RenovoRx’s unique approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III lead product candidate, RenovoGemTM, a novel oncology drug-device combination product, is being investigated under a US IND that is regulated by FDA 21 CFR 312 pathway. RenovoGem is currently being evaluated for the treatment of locally advanced pancreatic cancer (LAPC) by the Center for Drug Evaluation and Research (the drug division of FDA.)
RenovoRx is committed to transforming the lives of patients by delivering innovative solutions to change the current paradigm of cancer care. RenovoGem is currently under investigation for TAMP therapeutic delivery of gemcitabine and has not been approved for commercial sale.
For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and Twitter.
Cautionary Note Regarding Forward-Looking Statements
This press release contains 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, including but not limited to statements regarding (i) the anticipated benefits of the promotions of the Company’s executives as described herein and (ii) our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoCath®, RenovoGem™ or TAMP™ or regarding our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (iii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iv) our efforts to expand our intellectual property. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that the recently promoted executives will be unable to fulfill their roles as anticipated; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of our preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.
Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.
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Investor Contact:
KCSA Strategic Communications
Valter Pinto, Managing Director
T: 212-896-1254
renovorx@kcsa.com
Source: RenovoRx, Inc.
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