Oncorus Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Updates
March 09 2022 - 7:00AM
Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company
focused on driving innovation to transform outcomes for cancer
patients, today reported fourth quarter and full year 2021
financial results and highlighted recent achievements and
developments.
“In 2021, Oncorus made meaningful progress advancing our
pipeline of next-generation, systemically active viral
immunotherapies. With a broad range of activities across both our
innovative HSV and selectively self-amplifying vRNA/LNP platforms,
we are well-positioned to execute on multiple clinical and
preclinical catalysts this year as we build out our differentiated
portfolio of intratumorally and intravenously administered viral
immunotherapies,” said Theodore (Ted) Ashburn, M.D., Ph.D.,
President and Chief Executive Officer of Oncorus. “We remain on
track to report multiple clinical-stage milestones this year, with
both additional ONCR-177 data from the surface lesion monotherapy
expansion and the initial combination expansion data with KEYTRUDA
expected in the second half of 2022. We also continue to progress
our earlier stage programs, with ONCR-021 advancing into
IND-enabling studies, while we simultaneously build out our Andover
manufacturing facility to enable expansion of our portfolio.”
Fourth Quarter 2021 and Recent Business
Highlights
- Presented initial data from ongoing Phase 1 clinical
trial of ONCR-177 at the Society for Immunotherapy of Cancer's
(SITC) 36th Annual Meeting. In November 2021, Oncorus
presented initial safety, tolerability, immune activation and
clinical response data from its ongoing Phase 1 open-label,
multi-center, dose escalation and expansion clinical trial of
ONCR-177, an intratumorally (iTu) administered Herpes Simplex Virus
(HSV) viral immunotherapy, being developed for multiple solid tumor
indications. In the fully enrolled and completed surface lesion
dose escalation part of the Phase 1 study, ONCR-177 was well
tolerated with no dose-limiting toxicities. In addition, three of
eight evaluable patients at the Recommended Phase 2 Dose (RP2D)
across multiple indications (cutaneous melanoma, squamous cell
carcinoma of the head and neck and mucosal melanoma) experienced
clinical benefit after two doses of ONCR-177. The Phase 1
presentation at SITC marked Oncorus’ first reporting of human data
from its HSV platform.
- On track to report
additional ONCR-177 monotherapy and combination data in
2022. The Phase 1 open-label, multi-center, 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. The Company has completed enrollment in the dose expansion
portion of the trial and continues to enroll patients in the
combination cohort. Future data readouts are expected in the second
half of 2022 and will include both additional surface lesion
monotherapy expansion data for ONCR-177 and initial surface lesion
combination expansion data for ONCR-177 administered with
KEYTRUDA.
- Signed exclusive licensing
agreement with Gaeta Therapeutics for use of locally delivered
Interleukin-12 (IL-12) via oncolytic viral expression in
combination with immune checkpoint inhibitors. In November
2021, Oncorus signed an exclusive licensing agreement with Gaeta
Therapeutics for the use of locally delivered IL-12 via oncolytic
viral expression in combination with immune checkpoint inhibitors,
including CTLA-4, PD-1 or PD-L1 checkpoint blockade.
- Presented preclinical data
on ONCR-GBM at the International Oncolytic Virus Conference (IOVC)
2021. In November 2021, Oncorus presented a preclinical
poster describing 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. Leveraging its HSV 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.
- Selectively self-amplifying
viral RNA (vRNA) immunotherapy platform and
clinical candidates, ONCR-021 and ONCR-788, continue to
progress. Oncorus continues to progress its selectively
self-amplifying vRNA/lipid nanoparticle (LNP) platform and two
clinical candidates, ONCR-021 and ONCR-788, which employ the
company’s pioneering IV-administered approach of encapsulating the
genomes of RNA viruses known to kill cancer cells (i.e., oncolytic
viruses, or OVs) in LNPs. Oncorus is currently initiating GLP
safety and tolerability studies for ONCR-021 and anticipates
submitting an investigational new drug application (IND) for this
program in mid-2023. The company is also conducting preliminary
non-GLP safety and tolerability studies for ONCR-788. Oncorus plans
to investigate its novel selectively self-amplifying vRNA
immunotherapies in multiple therapeutic areas, including cancers of
the lung, both as monotherapy and in combination with immune
checkpoint inhibitors and possibly other cancer treatments.
- Strengthened executive leadership team with promotion
of John Goldberg, M.D., to Chief Medical Officer. In
February 2022, Oncorus announced the promotion of John Goldberg,
M.D. to Chief Medical Officer. Dr. Goldberg responsibilities will
continue to include oversight of all clinical studies, drug
development and regulatory strategies. Dr. Goldberg previously
served as Oncorus’ Senior Vice President of Clinical Development
since 2018.
Fourth Quarter 2021 Financial Results
- Cash and cash equivalents and investments totaled $123.9
million as of December 31, 2021 compared to $130.3 million as of
December 31, 2020.
- Research and development expenses for the quarter ended
December 31, 2021 were $14.3 million compared to $7.6 million for
the corresponding quarter in 2020. The increase was primarily
attributable to employee compensation costs, which was driven by
increased headcount and increased stock-based compensation,
increased rent expense related to the company’s manufacturing
facility and increased development costs related to the company’s
nominated candidates.
- General and administrative expenses for the quarter ended
December 31, 2021 were $5.6 million compared to $4.0 million for
the corresponding quarter in 2020. The increase was primarily
attributable to 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.
- Net loss attributable to common stockholders for the quarter
ended December 31, 2021 was $19.8 million, or $0.77 per share, as
compared to a net loss attributable to common stockholders of $11.8
million, or $0.56 per share for the corresponding quarter in 2020.
The increase in the net loss was due to increased expenses
associated with the company’s growth and the increase in net loss
per share was a result of the increased net loss offset by
additional shares issued by the Company in a public stock offering
in February 2021.
Financial Guidance
Based upon its current operating plans and cash and cash
equivalents and investments, 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
Herpes Simplex Virus (HSV) Platform and selectively self-amplifying
viral RNA (vRNA)/ lipid nanoparticle (LNP) Immunotherapy
Platform.
Designed to deliver next-generation viral immunotherapy impact,
our HSV Platform improves upon key characteristics of this
therapeutic class to enhance systemic activity. Our lead HSV
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 selectively self-amplifying 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 selectively
self-amplifying 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 Oncorus’ ability to execute on
multiple clinical and preclinical catalysts in 2022; the clinical
development of ONCR-177, including expectations regarding timing
for reporting additional data from the monotherapy expansion and
the combination expansion 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’ selectively self-amplifying vRNA Immunotherapy Platform;
expectations regarding manufacturing capabilities including the
buildout timeline of Oncorus’ clinical manufacturing facility; and
Oncorus’ belief that its current cash and investment 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, ONCR-788 and ONCR-GBM 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, 2021, to be filed with the
Securities and Exchange Commission on or about March 9, 2022, 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. Investor
Contact:Stern Investor Relations Julie
SeidelJulie.seidel@sternir.com
|
Oncorus, Inc. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(in thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
$ |
14,276 |
|
|
$ |
7,593 |
|
|
$ |
44,682 |
|
|
$ |
27,153 |
|
|
General and administrative |
|
5,586 |
|
|
|
3,968 |
|
|
|
20,136 |
|
|
|
10,000 |
|
Total operating expenses |
|
19,862 |
|
|
|
11,561 |
|
|
|
64,818 |
|
|
|
37,153 |
|
Loss from operations |
|
(19,862 |
) |
|
|
(11,561 |
) |
|
|
(64,818 |
) |
|
|
(37,153 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Change in fair value of Series B tranche rights |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(11,256 |
) |
|
Other expense |
|
(8 |
) |
|
|
(11 |
) |
|
|
(9 |
) |
|
|
(33 |
) |
|
Interest income |
|
27 |
|
|
|
5 |
|
|
|
65 |
|
|
|
143 |
|
|
|
Total other income (expense), net |
|
19 |
|
|
|
(6 |
) |
|
|
56 |
|
|
|
(11,146 |
) |
Net loss |
$ |
(19,843 |
) |
|
$ |
(11,567 |
) |
|
$ |
(64,762 |
) |
|
$ |
(48,299 |
) |
Accretion of discount and dividends on redeemable convertible
preferred stock |
|
- |
|
|
|
(229 |
) |
|
|
- |
|
|
|
(8,527 |
) |
Net loss attributable to common stockholders |
$ |
(19,843 |
) |
|
$ |
(11,796 |
) |
|
$ |
(64,762 |
) |
|
$ |
(56,826 |
) |
Comprehensive loss: |
|
|
|
|
|
|
|
|
Net unrealized loss on investments |
|
(14 |
) |
|
|
- |
|
|
|
(14 |
) |
|
|
- |
|
Comprehensive loss |
$ |
(19,857 |
) |
|
$ |
(11,567 |
) |
|
$ |
(64,776 |
) |
|
$ |
(48,299 |
) |
Net loss per share - basic and diluted |
$ |
(0.77 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.56 |
) |
|
$ |
(9.35 |
) |
Weighted-average number of common shares - basic and diluted |
|
25,814 |
|
|
|
21,126 |
|
|
|
25,320 |
|
|
|
6,080 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncorus, Inc. |
Selected Condensed Consolidated Balance Sheet
Data |
(in thousands) |
(Unaudited) |
|
|
|
|
|
|
|
December 31,2021 |
|
December 31,2020 |
Cash and cash equivalents |
|
|
|
|
$ |
100,752 |
|
|
$ |
130,305 |
|
Investments |
|
|
|
|
|
23,173 |
|
|
|
- |
|
Working capital (1) |
|
|
|
|
|
108,136 |
|
|
|
127,407 |
|
Right-of-use asset |
|
|
|
|
|
45,218 |
|
|
|
41,372 |
|
Total assets |
|
|
|
|
|
201,587 |
|
|
|
182,263 |
|
Long term lease liability |
|
|
|
|
|
50,388 |
|
|
|
41,615 |
|
Total liabilities |
|
|
|
|
|
71,565 |
|
|
|
47,599 |
|
Total stockholders' equity |
|
|
|
|
$ |
130,022 |
|
|
$ |
134,664 |
|
|
|
|
|
|
|
|
|
|
|
(1) Working capital is defined as current assets less current
liabilities |
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