Presented positive Phase III TIGeR-PaC interim
study results observing 8-month delay in cancer progression,
concordant with 6-month overall survival benefit and 65% reduction
in adverse effects over standard of care.
Announced collaboration with Imugene to explore
delivery of oncolytic virus therapy using proprietary
Trans-Arterial Micro-Perfusion (TAMP™) platform, expanding use from
targeting locally advanced disease to treating metastatic
disease.
RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a
clinical-stage biopharmaceutical company developing targeted
combination therapies, today announced financial results for the
second quarter ended June 30, 2023.
“We made strong progress this quarter and have continued
momentum in our commitment to transform the lives of patients by
delivering innovative solutions to change the current paradigm of
cancer care,” said Shaun Bagai, CEO of RenovoRx. “This quarter
marked significant milestones including positive interim data
presented from our pivotal Phase III TIGeR-PaC study, a strategic
collaboration to potentially utilize immunotherapy to expand our
platform to help metastatic patients, and key additions to our
leadership team, Board of Directors and Scientific Advisory Board.
We are also excited for the upcoming year, when we expect our
secondary interim analysis data readout.”
Key Business Highlights:
- Presented positive Phase III data demonstrating RenovoGem
delays cancer progression by 8-months, while providing a 6-month
overall survival benefit and 65% reduction in adverse effects over
standard of care in locally advanced pancreatic cancer patients, at
2023 ESMO World Congress in Gastrointestinal Cancer and American
Association for Cancer Research Annual Meeting.
- Initiated patient enrollment at the University of Texas
Southwestern Medical Center for pivotal Phase III TIGeR-PaC
clinical trial.
- Launched collaboration with Imugene Ltd (ASX: IMU) to explore a
better way to deliver oncolytic immunotherapy in difficult to
access to tumors, such as metastatic pancreatic cancer, using
RenovoRx’s proprietary TAMP therapy platform. This collaboration
potentially expands the market for the TAMP platform beyond locally
advanced to metastatic pancreatic cancer.
- Appointed Margaret A. Tempero, M.D., Director, UCSF Pancreas
Center and Leader of the UCSF Pancreas Cancer Program, to the
Company’s Scientific Advisory Board (SAB).
- Appointed Robert J. Spiegel, MD to the Company’s Board of
Directors. Dr. Spiegel is former Chief Medical Officer of
Schering-Plough ($41B merger with Merck MSD). His experience
includes involvement involved in more than 30 successful New Drug
Application (NDA) approvals by the FDA and the development and
launch of multiple products with annual sales exceeding $1B.
- Appointed Leesa Gentry as Senior Vice President of Clinical
Operations to lead RenovoRx’s expansive clinical programs. Ms.
Gentry is an industry expert in clinical trials management with
prior senior leadership experience at Evotec, PPD, Quintiles and
Otsuka America Pharmaceutical.
- Closed a registered direct offering and a concurrent private
placement for aggregate gross proceeds of $5 million.
Second Quarter 2023 Financial Results:
- Cash Position: Cash and cash equivalents as of June 30,
2023, were $6.0 million.
- R&D Expenses: Research and development expenses were
$1.9 million for the quarter ended June 30, 2023, compared to $1.4
million for the quarter ended June 30, 2022. The increase was
primarily due to our ongoing Phase III clinical trial costs and an
increase in employee and related benefits costs. This increase was
partially offset by a decrease in costs associated with a secondary
manufacturer.
- G&A Expenses: General and administrative expenses
were $1.4 million for the second quarter ended June 30, 2023,
compared to $1.2 million for the quarter ended June 30, 2022. This
increase was primarily due to higher employee and related benefits
costs due to an increased in headcount. This increase was partially
offset by a decrease in professional and consulting fees compared
to the same period last year.
- Net Loss: Net loss was $2.3 million for the quarter
ended June 30, 2023, compared to net loss of $2.6 million for the
quarter ended June 30, 2022.
- Shares Outstanding: Shares of common stock outstanding,
as of June 30, 2023, were 10,693,080.
About RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company
developing targeted combination therapies for high unmet medical
needs. The Company’s proprietary Trans-Arterial Micro-Perfusion
(TAMP™) therapy platform is designed to bypass traditional systemic
delivery methods and ensure precise therapeutic delivery to a
target tissue, while minimizing a therapy’s systemic toxicities.
RenovoRx’s unique approach to drug-delivery offers the potential
for increased treatment safety, tolerance, and wider therapeutic
windows. The Company’s lead product candidate, RenovoGem™ combines
gemcitabine with the company’s patented delivery system and is
regulated by FDA under the IND 21 CFR 312 pathway. RenovoGem is
currently in a Phase III clinical trial (TIGeR-PaC) for the
treatment of locally advanced pancreatic cancer, where it observed
a 6-month median Overall Survival benefit, 8-month progression-free
survival (PFS) and 65% reduction in adverse events at its interim
analysis. 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®, RenovoGem™ or TAMP™ 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; 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)
June 30, 2023
December 31, 2022
Cash, cash equivalents and marketable
securities
$
5,954
$
6,440
Total assets
$
6,314
$
7,265
Current liabilities
$
1,699
$
1,102
Common warrant liability
3,427
-
Total liabilities
$
5,126
$
1,102
Total stockholders’ equity
$
1,188
$
6,163
Total liabilities and stockholders’
equity
$
6,314
$
7,265
RenovoRx, Inc.
Condensed Statements of
Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and
per share amounts)
Three Months Ended
Six Months Ended
June 30,
June 30,
2023
2022
2023
2022
Operating expenses:
Research and development
$
1,925
$
1,390
$
3,263
$
2,679
General and administrative
1,450
1,224
3,373
2,940
Total operating expenses
3,375
2,614
6,636
5,619
Loss from operations
(3,375
)
(2,614
)
(6,636
)
(5,619
)
Other income/(expenses), net:
Interest and dividend income
50
20
54
21
Other income, net
-
-
-
1
Change in fair value of common warrant
liability
1,573
-
1,573
-
Transaction costs allocated to common
warrant liability
(575
)
-
(575
)
-
Total other income/(expenses), net
1,048
20
1,052
22
Net loss
(2,327
)
(2,594
)
(5,584
)
(5,597
)
Other comprehensive loss:
Unrealized loss on marketable
securities
-
(4
)
-
(4
)
Comprehensive loss
$
(2,327
)
$
(2,598
)
$
(5,584
)
$
(5,601
)
Net loss per share, basic and diluted
$
(0.22
)
$
(0.29
)
$
(0.57
)
$
(0.62
)
Weighted-average shares of common stock
outstanding, basic and diluted
10,655,155
9,057,185
9,881,371
9,024,973
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version on businesswire.com: https://www.businesswire.com/news/home/20230815934904/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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