Collaboration with Imugene further validates
TAMPTM (Trans-Arterial Micro-Perfusion) and will expand use of
RenovoRx’s delivery platform beyond chemotherapy to
immunotherapy.
The TAMP therapy platform is in a Phase III
clinical trial for the treatment of Pancreatic Cancer, interim
analysis was completed in March 2023, and the Data Monitoring
Committee recommended a continuation of the study.
TIGeR-PaC is prespecified to provide a primary
endpoint of a 6-month Overall Survival (OS) benefit and secondary
endpoints including reduced adverse events versus standard of
care.
RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a
clinical-stage biopharmaceutical company developing targeted
combination therapies, today announced financial results for the
third quarter ended September 30, 2023.
“We remain focused on our core mission to improve the lives of
patients diagnosed with difficult-to-treat cancers by delivering
novel targeted combination therapies that have the potential to
alter the current paradigm of oncology care,” said Shaun Bagai, CEO
of RenovoRx. “We are encouraged by the progress in our pivotal
Phase III TIGeR-PaC study, and the recent completed interim
analysis, along with our partnership with Imugene as we explore
pipeline expansion opportunities using our TAMP therapy
platform.”
Key Business Highlights:
●
Continued to advance Phase III TIGeR-PaC
clinical trial for the treatment of LAPC. The first of two interim
analyses was completed in March 2023, and the Data Monitoring
Committee recommended a continuation of the study. The study is
prespecified to provide a primary endpoint of a 6-month OS benefit
and secondary endpoints including reduced adverse events versus
standard of care. Additionally, Dr. Michael J. Pishvaian, Johns
Hopkins Medicine and Principal Investigator of TIGeR-PaC, presented
at the Global Summit on Gastrointestinal Malignancies in Bermuda.
The presentation, “Increasing Local Gemcitabine Delivery Using TAMP
in the Chemotherapy Advances in Pancreatic Cancer,” highlighted the
proprietary TAMP therapy platform and its design to ensure precise
delivery for targeted treatment of cancer, and its potential for
increased safety, tolerance, and improved efficacy.
●
Ripal Gandhi, FSIR, FSVM, investigator in
the TIGeR-PaC study, presented, “Advances in Pancreatic Cancer:
Trans-arterial Therapy on the Horizon,” at the Symposium on
Clinical Interventional Oncology (CIO) on September 22-24, 2023, in
Orlando, Florida. Dr. Gandhi highlighted the TAMP therapy platform
as a potential targeted treatment option for patients diagnosed
with locally advanced pancreatic cancer versus the standard of
care. Dr. Gandhi is a member of the Miami Cancer Institute and
Miami Cardiac and Vascular Institute physician team, a Clinical
Professor at Florida International University Herbert Wertheim
College of Medicine and Associate Professor at USF School of
Medicine.
●
Collaboration with Imugene Ltd (ASX: IMU)
further validates the TAMP platform and will expand use of
RenovoRx’s delivery platform beyond chemotherapy to
immunotherapy.
Financial Highlights for Third Quarter ended September 30,
2023:
●
Cash Position: Cash and cash
equivalents as of September 30, 2023, were $3.2 million.
●
R&D Expenses: Research and
development expenses were $1.6 million for the quarter ended
September 30, 2023, compared to $0.8 million for the quarter ended
September 30, 2022. The increase was primarily due to our ongoing
Phase III clinical trial cost of $0.4 million, an increase in
employee and related benefits costs of $0.3 million and general and
administrative allocated costs of $0.2 million. This increase was
partially offset by a decrease in costs associated with a secondary
manufacturer of $0.1 million.
●
G&A Expenses: General and
administrative expenses were $1.3 million for the third quarter
ended September 30, 2023, flat compared to the same period last
year. Employee and related benefits costs increased $0.3 million
compared to the same quarter last year. This increase was offset by
a decrease in directors’ and officers’ insurance expenses of $0.1
million, including allocation of general and administrative
expenses to research and development of $0.2 million.
●
Net Loss: Net loss was $1.4 million
for the quarter ended September 30, 2023, compared to net loss of
$2.1 million for the quarter ended September 30, 2022. The decrease
is primarily due to an increase in operating expenses of $0.8
million, offset by $1.5 million reported gain on the fair value of
common warrants issued under our Registered Direct Offering in
April 2023.
●
Shares Outstanding: Shares of
common stock outstanding, as of September 30, 2023, were
10,693,080.
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 is under investigation for targeted treatment with 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.
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 RenovoCath®, RenovoGemTM or TAMPTM 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
possibility that 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; our ability to comply with the
continued listing standards of Nasdaq Stock Market LLC (“Nasdaq”)
or the continued listing of our securities on Nasdaq; 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 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.
RenovoRx, Inc.
Selected Condensed Balance
Sheet Data
(Unaudited)
(in thousands)
September 30, 2023
December 31, 2022
Cash, cash equivalents and marketable
securities
$
3,226
$
6,440
Total assets
$
3,519
$
7,265
Current liabilities
$
1,605
$
1,102
Common warrant liability
1,908
-
Total liabilities
$
3,513
$
1,102
Total stockholders’ equity
$
6
$
6,163
Total liabilities and stockholders’
equity
$
3,519
$
7,265
RenovoRx, Inc.
Condensed Statements of
Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and
per share amounts)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
Operating expenses:
Research and development
$
1,629
$
846
$
4,892
$
3,525
General and administrative
1,354
1,315
4,727
4,255
Total operating expenses
2,983
2,161
9,619
7,780
Loss from operations
(2,983
)
(2,161
)
(9,619
)
(7,780
)
Other income/(expenses), net:
Interest and dividend income
43
22
97
43
Other income, net
-
3
-
4
Change in fair value of common warrant
liability
1,519
-
3,092
-
Transaction costs allocated to common
warrant liability
-
-
(575
)
-
Total other income/(expenses), net
1,562
25
2,614
47
Net loss
(1,421
)
(2,136
)
(7,005
)
(7,733
)
Other comprehensive loss:
Unrealized gain on marketable
securities
-
17
-
13
Comprehensive loss
$
(1,421
)
$
(2,119
)
$
(7,005
)
$
(7,720
)
Net loss per share, basic and diluted
$
(0.13
)
$
(0.24
)
$
(0.69
)
$
(0.86
)
Weighted-average shares of common stock
outstanding, basic and diluted
10,693,080
9,067,509
10,154,914
9,039,308
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231113527335/en/
Investor Contact: KCSA Strategic Communications Valter
Pinto or Jack Perkins T:212-896-1254 renovorx@kcsa.com
Media Contact: Kimberly Ha KKH Advisors 917-291-5744
kimberly.ha@kkhadvisors.com
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