Oncorus Reports Third Quarter 2021 Financial Results and Provides Business Updates
November 03 2021 - 7:00AM
Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company
focused on driving innovation to transform outcomes for cancer
patients, today reported third quarter 2021 financial results and
highlighted recent achievements and developments.
“We continue to make important progress advancing our broad
portfolio of next-generation viral immunotherapies and creating a
state-of-the-art process development and manufacturing
infrastructure to support our planned future development activities
and growth,” said Theodore (Ted) Ashburn, M.D., Ph.D., President
and Chief Executive Officer at Oncorus. “Our Phase 1 clinical trial
of ONCR-177 continues to enroll patients, and we are excited to
begin sharing data from this trial at SITC next week during a
poster presentation beginning on November 12th. Across our oHSV and
Synthetic vRNA Immunotherapy platforms we have multiple preclinical
efforts underway as we advance our next programs toward the clinic.
In addition, we are thrilled to report that the first phase of our
manufacturing facility has been completed, with Oncorus team
members now working onsite, overseeing process development
activities.”
Dr. Ashburn continued, “The breadth of activities we have
underway is a testament to the tremendous competence and
capabilities of our team. We continue to execute on our goal of
building the leading viral immunotherapies company, based on
world-class science, pipeline breadth, and an unwavering commitment
to cancer patients.”
Third Quarter 2021 and Recent Highlights
- Initial data to be presented
for ongoing Phase 1 clinical trial of ONCR-177 at SITC 2021, taking
place November 12 – 14 in Washington, DC and virtually.
Oncorus continues to enroll patients across 11 sites in the United
States and Canada in a Phase 1 clinical trial of ONCR-177, an
intratumorally (iTu) administered oHSV viral immunotherapy, being
developed for multiple solid tumor indications. The Phase 1
open-label, dose escalation and expansion clinical trial is
designed to evaluate the safety and tolerability of ONCR-177 alone
and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA®
(pembrolizumab), in patients with advanced and/or refractory
cutaneous, subcutaneous or metastatic nodal solid tumors or with
liver metastases of solid tumors. This presentation at SITC will
mark Oncorus’ first reporting of human data from its oHSV
platform.
- Continued to progress first Synthetic vRNA
immunotherapy clinical candidates, ONCR-021 and ONCR-788.
As disclosed earlier this year, ONCR-021 and ONCR-788 employ
Oncorus’ pioneering IV-administered approach of encapsulating the
genomes of RNA viruses known to kill cancer cells (i.e., oncolytic
viruses, or OVs) in lipid nanoparticles (LNPs), creating, to the
company’s knowledge, the first-ever Synthetic vRNA immunotherapy.
ONCR-021 encodes an optimized strain of CVA21 (Coxsackievirus A21);
ONCR-788 encodes a modified version of SVV (Seneca Valley Virus, or
SVV). CVA21 and SVV both have extensive clinical experience and
favorable safety profiles when administered intravenously. Oncorus’
novel Synthetic vRNA approach holds the potential for IV
administration while avoiding the challenge of neutralizing
antibodies seen in previous approaches with IV-administered OVs.
(Learn more about Oncorus’ novel Synthetic vRNA Immunotherapy
approach.)Oncorus is currently initiating GLP safety and
tolerability studies for ONCR-021 and anticipates submitting an IND
for this program in the first half of 2023. The company is also
conducting preliminary non-GLP safety and tolerability studies for
ONCR-788 and is not yet providing guidance on timing of an IND
submission for this program. Oncorus plans to investigate its novel
Synthetic vRNA immunotherapies in multiple histologies, including
cancers of the lung, both as monotherapy and in combination with
immune checkpoint inhibitors and possibly other cancer
treatments.
- Upcoming preclinical
presentation on ONCR-GBM at the International Oncolytic Virus
Conference (IOVC) 2021. Leveraging its oHSV platform,
Oncorus is pursuing ONCR-GBM to specifically target brain cancer,
including glioblastoma multiforme (GBM). The company is utilizing
its knowledge of microRNA expression to engineer a microRNA
attenuation strategy to protect healthy brain tissue and to select
a rational combination of payloads intended to address both the
cancer itself and the specific drivers of immune suppression in the
brain. Oncorus plans to submit an IND for ONCR-GBM in the second
half of 2023.Oncorus will present a poster titled, “ONCR-GBM: A
Novel, Armed Oncolytic HSV-1 Vector Engineered for Efficacy and
Safety in Glioblastoma” (Poster #10226), at IOVC 2021, which will
take place November 5 – 7 in Sedona, Arizona and virtually. Part of
the conference’s Virtual Poster Session, Oncorus’ e-poster will
describe the design and evaluation of multiple features that will
be incorporated into the ONCR-GBM program, including robust
anti-tumor activity observed with IL-12 and a proprietary PD-1
antagonist nanobody. Link to the meeting website here.
- Completed first phase of
Process Development and Good Manufacturing Practice (GMP) viral
immunotherapy clinical manufacturing facility
buildout. Oncorus has completed the
first phase of its state-of-the-art, 88,000 square foot process
development and GMP viral immunotherapy clinical manufacturing
facility in Andover, Mass. Oncorus is building out the expansive
facility to provide a comprehensive solution for its Chemistry,
Manufacturing and Controls (CMC) development needs, enabling the
manufacture, quality control and supply of clinical-grade viral
immunotherapies for IND-enabling and clinical studies. Process
development and GMP readiness activities are now underway at the
site. Oncorus anticipates the buildout to be completed and the site
to be fully operational, including GMP multi-product manufacturing
capabilities, in the first half of 2023.
Third Quarter Financial Results
- Cash and cash equivalents were $145.6
million as of September 30, 2021 compared to $130.3 million as of
December 31, 2020.
- Research and development expenses for
the quarter ended September 30, 2021 were $11.3 million compared to
$6.9 million for the corresponding quarter in 2020. The increase in
research and development expenses was mainly attributable to
increased employee compensation costs, which was driven by
increased headcount and increased stock-based compensation,
increased rent expense related to the company’s new manufacturing
facility and increased development costs related to the company’s
nominated candidates.
- General and administrative expenses
for the quarter ended September 30, 2021 were $5.4 million compared
to $2.0 million for the corresponding quarter in 2020. The increase
in general and administrative expenses was primarily attributable
to increases in employee compensation costs, including higher
stock-based compensation, increased headcount and increased salary
and related expenses. General and administrative expenses also
increased due to higher insurance expense and professional and
consultant expenses related to operating as a public company.
- Other income (expense), net, for the
quarter ended September 30, 2021 was income of $0.01 million
compared to an expense of $10.6 million for the quarter
ended September 30, 2020. The expense for the quarter ended
September 30, 2020 included a non-cash charge of $10.6
million related to an increase in the fair market value of the
company’s Series B preferred stock tranche rights liability that
was settled in September 2020.
- Net loss attributable to common
stockholders for the quarter ended September 30, 2021 was $16.7
million, or $0.65 per share, as compared to a net loss attributable
to common stockholders of $22.4 million, or $21.73 per share for
the same quarter in 2020. The share and net loss per share amounts
in the third quarter of 2021 include the impact of Oncorus’ IPO,
which closed in October 2020, including the conversion of
outstanding preferred stock into approximately 15.0 million shares
of common stock.
Financial Guidance
Based upon its current operating plans and cash and cash
equivalents, Oncorus expects to have sufficient capital to fund its
operating expenses and capital expenditure requirements into late
2023.
About Oncorus
At Oncorus, we are focused on driving innovation to deliver
next-generation viral immunotherapies to transform outcomes for
cancer patients. We are advancing a portfolio of intratumorally
(iTu) and intravenously (IV) administered viral immunotherapies for
multiple indications with significant unmet need based on our
oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic viral
RNA (vRNA) Immunotherapy Platform.
Designed to deliver next-generation viral immunotherapy impact,
our oHSV Platform improves upon key characteristics of this
therapeutic class to enhance systemic activity. Our lead oHSV
program, ONCR-177, is designed to be directly administered into a
tumor, resulting in high local concentrations of the therapeutic
agent and its five encoded transgenes, as well as low systemic
exposure to the therapy, which could limit systemic toxicities. Our
pioneering Synthetic vRNA Immunotherapy Platform involves a highly
innovative, novel combination of RNA- and oncolytic virus-based
modalities designed to realize the potential of RNA medicines for
cancer. Our lead IV-administered Synthetic vRNA Immunotherapy
clinical candidates, ONCR-021 and ONCR-788, are both currently in
IND-enabling studies.
Please visit www.oncorus.com to learn more.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, implied and
express statements regarding the clinical development of ONCR-177,
including expectations regarding timing for reporting data from the
ongoing Phase 1 clinical trial, as well as the product candidate’s
therapeutic potential and clinical benefits and the utility and
potential of Oncorus’ oHSV Platform; Oncorus’ expectations
regarding its other potential product candidates, including the
timing of the submission of an IND for its second oHSV Platform
program, ONCR-GBM, and the design thereof; the preclinical and
clinical development of ONCR-021 and ONCR-788, including
expectations regarding timing for submitting INDs, as well as the
product candidates’ therapeutic potential and clinical benefits and
the utility and potential of Oncorus’ Synthetic vRNA Immunotherapy
Platform; Oncorus’ belief that it is creating the first-ever
Synthetic vRNA immunotherapy; expectations regarding manufacturing
capabilities including the buildout timeline of Oncorus’ viral
immunotherapy clinical manufacturing facility and readiness for GMP
production; and Oncorus’ belief that its current cash resources
will be sufficient to fund its operations and capital expenditure
requirements into late 2023. The words "may," “might,” "will,"
"could," "would," "should," "expect," "plan," "anticipate,"
"intend," "believe," “expect,” "estimate," “seek,” "predict,"
“future,” "project," "potential," "continue," "target" and similar
words or expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Any forward-looking statements in this
press release are based on management's current expectations and
beliefs and are subject to a number of risks, uncertainties and
important factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, risks associated with: the impact of COVID-19 on
Oncorus’ operations and the timing and anticipated results of its
ongoing and planned clinical trials; the risk that the results of
preclinical studies and clinical trials may not be predictive of
future results in connection with future clinical trials; Oncorus’
ability to successfully demonstrate the safety, tolerability and
efficacy of ONCR-177, ONCR-021 and ONCR-788 and obtain regulatory
approval thereof; Oncorus’ ability to obtain the requisite
components for its product candidates manufactured in accordance
with regulatory requirements; the expansion of Oncorus’ in-house
manufacturing capabilities; the adequacy of Oncorus’ existing
capital resources and availability of financing on commercially
reasonable terms; the accuracy of the Oncorus’ estimates regarding
expenses, future revenue, capital requirements and needs for
additional financing; and Oncorus’ ability to obtain, maintain and
protect its intellectual property. These and other risks and
uncertainties are described in greater detail in the section
entitled "Risk Factors" in Oncorus’ Annual Report on Form 10-K for
the year ended December 31, 2020, filed with
the Securities and Exchange Commission on March 10,
2021, as well as discussions of potential risks, uncertainties, and
other important factors in the other filings
that Oncorus makes with the Securities and Exchange
Commission from time to time. These documents are available
under the “SEC filings” page of the Investors section of Oncorus’
website at http://investors.oncorus.com. Any forward-looking
statements represent Oncorus’ views only as of the date of this
press release and should not be relied upon as representing its
views as of any subsequent date. Oncorus explicitly
disclaims any obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law. No representations or warranties
(expressed or implied) are made about the accuracy of any such
forward-looking statements.
Media Contact:Liz Meloneliz@scientpr.com
Investor Contact:Stern Investor RelationsJulie
SeidelJulie.seidel@sternir.com
|
|
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
|
(in thousands, except per share data) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
$11,299 |
|
|
$6,927 |
|
|
$30,406 |
|
|
$19,560 |
|
|
General and
administrative |
|
5,440 |
|
|
|
1,973 |
|
|
|
14,550 |
|
|
|
6,032 |
|
Total operating
expenses |
|
16,739 |
|
|
|
8,900 |
|
|
|
44,956 |
|
|
|
25,592 |
|
Loss from
operations |
|
(16,739 |
) |
|
|
(8,900 |
) |
|
|
(44,956 |
) |
|
|
(25,592 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Change in fair
value of Series B tranche rights |
|
- |
|
|
|
(10,631) |
|
|
|
- |
|
|
|
(11,256) |
|
|
Other expense |
|
- |
|
|
|
(2) |
|
|
|
(1) |
|
|
|
(22) |
|
|
Interest
income |
|
11 |
|
|
|
2 |
|
|
|
38 |
|
|
|
138 |
|
|
Total other income (expense), net |
|
11 |
|
|
|
(10,631 |
) |
|
|
37 |
|
|
|
(11,140 |
) |
Net loss and
comprehensive loss |
$(16,728 |
) |
|
$(19,531 |
) |
|
$(44,919 |
) |
|
$(36,732 |
) |
Accretion of
discount and dividends on redeemable convertible preferred
stock |
|
- |
|
|
|
(2,848 |
) |
|
|
- |
|
|
|
(8,298 |
) |
Net loss
attributable to common stockholders |
$(16,728 |
) |
|
$(22,379 |
) |
|
$(44,919 |
) |
|
$(45,030 |
) |
Net loss per share
- basic and diluted |
$(0.65 |
) |
|
$(21.73 |
) |
|
$(1.79 |
) |
|
$(44.58 |
) |
Weighted-average
number of common shares - basic and diluted |
|
25,748 |
|
|
|
1,030 |
|
|
|
25,153 |
|
|
|
1,010 |
|
|
|
|
|
|
|
|
|
|
|
Oncorus, Inc. |
|
Selected Condensed Consolidated Balance Sheet
Data |
|
(in thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
September 30, 2021 |
|
December 31, 2020 |
Cash and cash
equivalents |
|
|
|
|
$145,603 |
|
$130,305 |
Working capital
(1) |
|
|
|
|
|
135,376 |
|
|
127,407 |
Right-of-use
asset |
|
|
|
|
|
37,428 |
|
|
41,372 |
Total assets |
|
|
|
|
|
202,727 |
|
|
182,263 |
Long term lease
liability |
|
|
|
|
|
42,329 |
|
|
41,615 |
Total
liabilities |
|
|
|
|
|
54,885 |
|
|
47,599 |
Total
stockholders' equity |
|
|
|
|
|
147,842 |
|
|
134,664 |
|
|
|
|
|
|
|
|
|
|
(1) Working capital is defined as current assets
less current liabilities
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