RenovoRx Reports Full Year 2022 Financial Results and Achievement of Important Phase III Clinical Study Milestone
RenovoRx (Nasdaq: RNXT) reports financial results for 2022 and updates on its Phase III TIGeR-PaC clinical trial for localized pancreatic cancer treatment. The company has randomized 47 out of 114 patients, triggering its first interim analysis after recording 26 events (deaths). RenovoRx anticipates releasing the interim analysis results soon. Financially, cash and equivalents were $6.4 million at year-end, with total assets of $7.3 million against liabilities of $1.1 million. The company's net loss was $9.9 million, with a loss per share of ($1.09). Operating expenses increased to $10 million, driven by R&D and admin costs.
- Anticipation of interim analysis results for TIGeR-PaC trial.
- Cash and equivalents at $6.4 million sufficient to fund operations into Q3 2023.
- Patent issued extending IP coverage for RenovoTAMP therapy platform.
- Net loss increased to $9.9 million compared to $6.3 million in 2021.
- Total operating expenses rose significantly to $10 million, impacting financial stability.
First of Two Planned Interim Analyses Triggered
Company and Data Monitoring Committee Conducting Review
Results of Analysis Forthcoming
TIGeR-PaC is a randomized multi-center Phase III open label clinical trial designed to investigate the Company’s first product candidate, RenovoGemTM, which utilizes RenovoRx’s proprietary therapy platform, RenovoTAMP®, to provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT). The study is comparing treatment with RenovoTAMP versus standard of care systemic intravenous (IV) administration of gemcitabine and nab-paclitaxel. The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and SBRT. Final analysis will be conducted after 86 protocol-specified events have occurred in the SBRT population with two planned interim analyses: the first analysis when
“RenovoRx has continued to grow in 2022 as we have focused on advancing our innovative therapy platform with the vision of disrupting the current standard of care,” said
Fiscal Year 2022 and Subsequent Operational Highlights:
- Announced Initial Results in Pharmacokinetic Substudy at the 2023 ASCO Gastrointestinal Cancer Symposium: Data on RenovoGem supports potential for RenovoTAMP therapy platform to increase local gemcitabine delivery and decrease side effects of pancreatic cancer treatment
-
Eighth
U.S. patent issued extending the intellectual property coverage of the RenovoTAMP therapy platform - Acceptance of four clinical data abstracts at the 2023 ASCO Gastrointestinal Cancer Symposium
- Presented RenovoTAMP therapy platform at the Advanced Interventional Management Symposium
- Presented at Symposium on Clinical Interventional Oncology
-
Appointed
Angela Gill Nelms as Chief Operating Officer -
Appointed
James Ahlers as Chief Financial Officer -
Participated in
University of Cambridge Academy of Therapeutic Sciences Gateway to Translation Seminar Series - Presented preclinical research data demonstrating potential utility for treatment of bile duct cancer
-
Enrolled first pancreatic cancer patient at Columbia University’s
New York-Presbyterian Hospital Irving Medical Center in TIGeR-PaC clinical trial study -
Presented at 2022
SPECTRUM Conference
Financial Highlights for the Fiscal Year Ended
-
Cash, cash equivalents and marketable securities as of
December 31, 2022 , were$6.4 million -
Total assets and total liabilities as of
December 31, 2022 , were$7.3 million $1.1 million -
Total operating expenses were
$10.0 million December 31, 2022 , compared to$5.7 million December 31, 2021 . The increase was related to higher research and development expenses and general and administrative expenses. -
Research and development expenses were
$4.3 million December 31, 2022 , compared to$3.0 million December 31, 2021 . The increase was primarily related to higher costs for contracted research development and consulting, including employee related costs and costs associated with a secondary manufacturer for the RenovoCath® delivery system. In addition, allocated general administrative support costs increased during the year. -
General and administrative expenses were
$5.6 million December 31, 2022 , compared to$2.6 million December 31, 2021 . The increase was primarily related to higher professional and consulting costs, including legal expenses, employee-related costs and D&O and liability insurance and other expenses. The increase was partially offset by general and administrative support costs allocated to research and development expenses. -
Net loss was
$9.9 million December 31, 2022 , compared to net loss of$6.3 million December 31, 2021 . -
Net loss per share, basic and diluted were (
$1.09 December 31, 2022 , compared to ($1.21 December 31, 2021 . -
As of
December 31, 2022 the Company had 9,097,701 common shares outstanding.
About RenovoGem
RenovoGem™ is the first drug-device combination product candidate that utilizes the RenovoTAMP® therapy platform via pressure-mediated delivery technology to deliver gemcitabine, an FDA-approved chemotherapy, locally across the arterial wall to bathe tumor tissue in the chemotherapy. RenovoGem is currently being evaluated in the Phase III TIGeR-PaC clinical trial study in Locally Advanced Pancreatic Cancer (LAPC) patients. The Company plans to investigate RenovoGem in extrahepatic Cholangiocarcinoma (eCCA) in a clinical trial, which is anticipated to begin in the first half of 2023.
About
RenovoRx’s patent portfolio for its therapy platform and product candidates includes eight issued
Learn more by visiting the
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 our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoTAMP®, RenovoCath® or RenovoGemTM or regarding our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, statements regarding the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and our preliminary financial results, cash position and related ability to continue as a going concern. 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, clinical trials, therapy platform, business 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 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: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; the interim results may not be predictive of the outcome of our clinical trial, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, or the regulatory authority may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; our ability to use and expand our therapy platform to build a pipeline of product candidates; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; 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; the commercialization potential of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; negative impacts of the ongoing COVID-19 pandemic on our operations; and other risks. 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
Forward-looking statements included herein are made as of the date hereof, and
| Selected Balance Sheets Data | |||||||||
| (in thousands) | |||||||||
|
2022 |
|
|
2021 |
|
||||
(unaudited) |
|||||||||
| Cash, cash equivalents and marketable securities | $ |
6,440 |
|
$ |
15,192 |
|
|||
| Total assets | $ |
7,265 |
|
$ |
16,287 |
|
|||
| Total liabilities | $ |
1,102 |
|
$ |
938 |
|
|||
| Total stockholders' equity | $ |
6,163 |
|
$ |
15,349 |
|
|||
| Total liabilities and stockholders' equity | $ |
7,265 |
|
$ |
16,287 |
|
|||
| Selected Statement of Operations Data | |||||||||
| (in thousands, except for share and per share amount) | |||||||||
| Year Ended | |||||||||
|
2022 |
|
|
2021 |
|
||||
(unaudited) |
|||||||||
| Operating expenses: | |||||||||
| Research and development | $ |
4,301 |
|
$ |
3,039 |
|
|||
| General and administrative |
|
5,649 |
|
|
2,632 |
|
|||
| Total Operating expenses |
|
9,950 |
|
|
5,671 |
|
|||
| Loss from operations |
|
(9,950 |
) |
|
(5,671 |
) |
|||
| Other income (expenses), net |
|
61 |
|
|
(653 |
) |
|||
| Net loss |
|
(9,889 |
) |
|
(6,324 |
) |
|||
| Other comprehensive income |
|
17 |
|
|
- |
|
|||
| Comprehensive loss | $ |
(9,872 |
) |
$ |
(6,324 |
) |
|||
| Net loss per share, basic and diluted | $ |
(1.09 |
) |
$ |
(1.21 |
) |
|||
| Weighted-average shares of common stock outstanding, basic and diluted |
|
9,051,726 |
|
|
5,217,000 |
|
|||
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Investor Contact:
T:212-896-1254
renovorx@kcsa.com
Media Contact:
T: 214-732-9392
kknightpr@gmail.com
Source:
FAQ
What are the recent financial results for RenovoRx (RNXT) for the year ended December 31, 2022?
When will RenovoRx (RNXT) release the results of its first interim analysis?
How many patients are enrolled in the TIGeR-PaC trial by RenovoRx (RNXT)?
What is the financial status of RenovoRx (RNXT) as of December 31, 2022?
