Oncorus Reports Third Quarter 2022 Financial Results and Provides Business Updates
02 Novembre 2022 - 12:00PM
Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company
focused on driving innovation to transform outcomes for cancer
patients, today reported financial results for the third quarter of
2022 and highlighted recent achievements and developments.
“We continue to focus on our differentiated portfolio of
intratumorally and intravenously administered viral immunotherapies
across our two platforms. We’ve been tracking well against our set
milestones for this year and are well positioned for further
advancement across our portfolio,” said Theodore (Ted) Ashburn,
M.D., Ph.D., President and Chief Executive Officer of Oncorus.
“We’ve bolstered our position within the viral immunotherapy
landscape with the recent relocation of our company to our facility
in Andover, Massachusetts, bringing research, process development
and GMP-compliant manufacturing under one roof. With the completion
of Andover, we are realizing our goal of becoming a fully
integrated viral immunotherapies company. We are preparing to
announce further data from our ongoing clinical trial of ONCR-177
in the fourth quarter of this year. In parallel, we are rapidly
progressing our vRNA/LNP immunotherapy platform, further supported
by the recent publication of promising preclinical results in
Nature Communications. We expect an IND submission for our lead
vRNA/LNP product candidate, ONCR-021, in mid-2023.”
Third Quarter 2022 and Recent Business
Highlights
- On track to report
combination data and additional monotherapy data for ONCR-177 in
the fourth quarter of 2022. Oncorus continues to dose
patients in its Phase 1 open-label, multi-center clinical trial in
patients with advanced and/or refractory cutaneous, subcutaneous or
metastatic nodal solid tumors or with liver metastases of solid
tumors. The company expects to report initial surface lesion
combination expansion data for ONCR-177 administered with Merck’s
KEYTRUDA and additional surface lesion monotherapy expansion data
in the fourth quarter of 2022.
- Preclinical results featured
in Nature Communications
supporting intravenously administered self-amplifying viral
RNA (vRNA)/lipid nanoparticle (LNP) immunotherapy
platform. In October 2022, Oncorus published preclinical
data in Nature Communications highlighting the potential of its
vRNA/LNP immunotherapy platform as a novel approach to treating
cancer through repeat intravenous (IV) administration. The data
demonstrate vRNA/LNP delivery and selective replication, virus
assembly, spread and lysis of tumor cells, leading to potent
anti-tumor efficacy even in the presence of virus neutralizing
antibodies in the bloodstream. Oncorus remains on track to submit
an investigational new drug application (IND) for the company’s
lead product candidate from this platform, ONCR-021, in
mid-2023.
- Completed construction phase
of Good Manufacturing Practice (GMP) -compliant manufacturing
facility in Andover, Massachusetts. Oncorus built its
state-of-the-art, 105,000 square foot process development and
GMP-compliant clinical manufacturing facility as a comprehensive
solution for its Chemistry, Manufacturing and Controls (CMC)
development needs, allowing for the manufacture, quality control
and supply of clinical-grade viral immunotherapies for its
IND-enabling and clinical studies. The company also relocated all
personnel and corporate activities to the facility, enabling
collaboration among company personnel and enhanced efficiency.
Third Quarter 2022 Financial Results
- Cash and cash equivalents and investments totaled $81.5 million
as of September 30, 2022 compared to $123.9 million as of December
31, 2021.
- Research and development expenses for the quarter ended
September 30, 2022 were $14.1 million compared to $11.3 million for
the corresponding quarter in 2021. The increase was primarily
attributable to increased headcount, which drove higher employee
compensation and stock-based compensation, increased development
costs related to the company’s nominated candidates, as well as
increased rent expense related to the company’s manufacturing
facility.
- General and administrative expenses for the quarter ended
September 30, 2022 were $5.2 million compared to $5.4 million for
the corresponding quarter in 2021. The slight decrease was
primarily attributable to lower recruiting and consulting
costs.
- Net loss for the quarter ended September 30, 2022 was $19.6
million, or $0.76 per share, as compared to a net loss of $16.7
million, or $0.65 per share for the corresponding quarter in
2021.
Financial Guidance
Oncorus expects its cash, cash equivalents and investments to
fund its capital expenditures and operating expenses into early
2024.
About Oncorus
At Oncorus, we are focused on driving innovation to deliver
next-generation viral immunotherapies to stimulate the immune
system and 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 Herpes Simplex Virus (HSV) and
self-amplifying viral RNA/LNP Immunotherapy Platforms.
Our HSV Platform is designed to improve upon key characteristics
of viral immunotherapies to enhance systemic activity. Our lead HSV
program, ONCR-177, which is currently in the clinic, 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 self-amplifying
vRNA/LNP Immunotherapy Platform, highlighted by our product
candidates ONCR-021 and ONCR-788, involves a highly innovative,
novel combination of RNA and LNP-based modalities designed to
realize the potential of RNA medicines for cancer.
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 enrollment, dosing and timing for
reporting additional data from the monotherapy and combination arms
of 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’ HSV Platform; the preclinical and
clinical development of ONCR-021 and ONCR-788, including
expectations regarding timing for submitting an IND for ONCR-021,
as well as the product candidates’ therapeutic potential and
clinical benefits and the utility and potential of Oncorus’
self-amplifying vRNA Immunotherapy Platform; and Oncorus’ belief
that its current cash and investment resources will be sufficient
to fund its operations and capital expenditure requirements into
early 2024. 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: Oncorus’ ability to successfully demonstrate the safety,
tolerability and efficacy of its product candidates and obtain
regulatory approval thereof; the adequacy of Oncorus’ existing
capital resources and availability of financing on commercially
reasonable terms; 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 impact of COVID-19 on Oncorus’
operations and the timing and anticipated results of its ongoing
and planned clinical trials; 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, 2021, filed with the Securities and
Exchange Commission (“SEC”) on March 9, 2022, Oncorus’ Quarterly
Reports on Form 10-Q for the quarters ended March 31, 2022 and June
30, 2022, filed with the SEC on May 4, 2022 and August 4, 2022,
respectively, and Oncorus’ Quarterly Report on Form 10-Q for the
quarter ended September 30, 2022, to be filed with the SEC on or
about November 2, 2022, as well as discussions of potential risks,
uncertainties, and other important factors in the other filings
that Oncorus makes with the SEC 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.
Investor Contact:Stern Investor
Relations Julie SeidelJulie.seidel@sternir.com
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Oncorus, Inc. |
|
|
|
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
|
|
|
(in thousands, except share and per share
data) |
|
|
|
(Unaudited) |
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
14,088 |
|
|
$ |
11,299 |
|
|
$ |
39,036 |
|
|
$ |
30,406 |
|
General and administrative |
|
5,211 |
|
|
|
5,440 |
|
|
|
16,721 |
|
|
|
14,550 |
|
Total operating expenses |
|
19,299 |
|
|
|
16,739 |
|
|
|
55,757 |
|
|
|
44,956 |
|
Loss from operations |
|
(19,299 |
) |
|
|
(16,739 |
) |
|
|
(55,757 |
) |
|
|
(44,956 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Other income |
|
(73 |
) |
|
|
- |
|
|
|
(75 |
) |
|
|
(1 |
) |
Interest expense |
|
(670 |
) |
|
|
- |
|
|
|
(1,261 |
) |
|
|
- |
|
Interest income |
|
421 |
|
|
|
11 |
|
|
|
602 |
|
|
|
38 |
|
Total other income (expense), net |
|
(321 |
) |
|
|
11 |
|
|
|
(734 |
) |
|
|
37 |
|
Net loss |
$ |
(19,620 |
) |
|
$ |
(16,728 |
) |
|
$ |
(56,491 |
) |
|
$ |
(44,919 |
) |
Comprehensive loss: |
|
|
|
|
|
|
|
Net unrealized loss on investments |
|
(32 |
) |
|
|
- |
|
|
|
(73 |
) |
|
|
- |
|
Comprehensive loss |
$ |
(19,652 |
) |
|
$ |
(16,728 |
) |
|
$ |
(56,564 |
) |
|
$ |
(44,919 |
) |
Net loss per share - basic and diluted |
$ |
(0.76 |
) |
|
$ |
(0.65 |
) |
|
$ |
(2.18 |
) |
|
$ |
(1.79 |
) |
Weighted-average number of
common shares |
|
25,972 |
|
|
|
25,748 |
|
|
|
25,907 |
|
|
|
25,153 |
|
|
|
|
|
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Oncorus, Inc. |
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Selected Condensed Consolidated Balance Sheet
Data |
|
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(in thousands) |
|
|
|
(Unaudited) |
|
|
|
|
September 30,2022 |
|
December 31,2021 |
|
|
|
|
Cash and cash equivalents |
$ |
41,568 |
|
|
$ |
100,752 |
|
|
|
|
|
Investments |
|
39,955 |
|
|
|
23,173 |
|
|
|
|
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Working capital (1) |
|
66,666 |
|
|
|
108,136 |
|
|
|
|
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Property and equipment, net |
|
42,883 |
|
|
|
23,233 |
|
|
|
|
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Right-of-use asset |
|
33,997 |
|
|
|
45,218 |
|
|
|
|
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Total assets |
|
164,365 |
|
|
|
201,587 |
|
|
|
|
|
Debt, net of debt discount and issuance fees |
|
19,257 |
|
|
|
- |
|
|
|
|
|
Long term lease liability |
|
48,147 |
|
|
|
50,388 |
|
|
|
|
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Total liabilities |
|
84,369 |
|
|
|
71,565 |
|
|
|
|
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Total stockholders' equity |
|
79,996 |
|
|
|
130,022 |
|
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(1) Working capital is defined as current assets less current
liabilities |
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