Oncorus Reports First Quarter 2022 Financial Results and Provides Business Updates
May 04 2022 - 7:00AM
Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company
focused on driving innovation to transform outcomes for cancer
patients, today reported first quarter 2022 financial results and
highlighted recent achievements and developments.
“Early 2022 has been focused on clinical and operational
execution as we work toward operational completion of our
manufacturing facility, as well as extending our cash runway to
support our dual platform approach to next-generation viral
immunotherapies. We plan to share additional ONCR-177 Phase 1 data
from the surface lesion monotherapy expansion and the initial
combination expansion data with KEYTRUDA in the second half of
2022, while we continue to advance our vRNA drug candidates and LNP
capabilities in parallel,” said Theodore (Ted) Ashburn, M.D.,
Ph.D., President and Chief Executive Officer of Oncorus. “We
recently presented exciting preclinical data from our selectively
self-amplifying vRNA/LNP immunotherapy platform at AACR
demonstrating the full potential of our IV-administered viral
immunotherapy candidates, ONCR-021 and ONCR-788, in overcoming
well-established limitations of RNA-based therapeutics. We look
forward to further positioning Oncorus for growth driven by our
dual-platform pipeline of product candidates targeting cancers with
significant unmet need, which is enabled by our wholly owned
GMP-compliant manufacturing infrastructure.”
First Quarter 2022 and Recent Business
Highlights
- On track to report
additional ONCR-177 monotherapy and combination data in the second
half of 2022. Oncorus has completed enrollment in the dose
expansion portion of its Phase 1 open-label, multi-center trial in
patients with advanced and/or refractory cutaneous, subcutaneous or
metastatic nodal solid tumors or with liver metastases of solid
tumors. The Company continues to enroll patients in the combination
cohort with future data readouts expected in the second half of
2022. Data readouts are expected to include both additional surface
lesion monotherapy expansion data for ONCR-177 and initial surface
lesion combination expansion data for ONCR-177 administered with
KEYTRUDA.
- Presented preclinical data
for ONCR-021 and ONCR-788 supporting the company’s selectively
self-amplifying viral RNA (vRNA)/lipid nanoparticle (LNP)
immunotherapy platform at the American Association for
Cancer Research (AACR) Annual Meeting 2022. In April 2022,
Oncorus presented preclinical data for both ONCR-021 and ONCR-788
in two e-posters at the AACR Annual Meeting demonstrating robust
preclinical anti-tumor efficacy in multiple tumor models while
avoiding the challenges seen in previous studies that incorporate
IV administration of RNA-based oncology therapeutics. Oncorus plans
to submit an investigational new drug (IND) application for
ONCR-021 with the U.S. Food and Drug Administration (FDA) in
mid-2023 and a subsequent IND submission for ONCR-788.
- Announced debt capital
facility with K2 HealthVentures (K2HV); $20 million funded at
closing: In April 2022, Oncorus entered into a loan and
security agreement with K2HV, a healthcare-focused specialty
finance company. The term loan facility provides Oncorus with up to
$45 million available in multiple tranches upon the achievement of
certain time-based, clinical and regulatory milestones, with the
initial tranche of $20 million funded at closing. Oncorus intends
to use the proceeds of the initial tranche of the loan facility to
complete the buildout of its Andover facility and to continue the
advancement of its pipeline of next generation viral
immunotherapies for cancer and LNP technologies.
- Announced relocation of all
operations to Andover, Massachusetts facility in fourth quarter of
2022 to increase operational efficiency: In April 2022,
Oncorus announced plans to relocate all operations to its facility
in Andover, Massachusetts in the fourth quarter of 2022, allowing
research, process development and Good Manufacturing Practice
(GMP)-compliant manufacturing to occur all in one facility.
First Quarter 2022 Financial Results
- Cash and cash equivalents and investments totaled $98.7 million
as of March 31, 2022 compared to $123.9 million as of December 31,
2021.
- Research and development expenses for the quarter ended March
31, 2022 were $12.5 million compared to $8.4 million for the
corresponding quarter in 2021. The increase was primarily
attributable to employee compensation costs, which was driven by
increased headcount and increased 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 March
31, 2022 were $5.3 million compared to $4.2 million for the
corresponding quarter in 2021. The increase was primarily
attributable to employee compensation costs, including higher
stock-based compensation, increased headcount and increased salary
and related expenses.
- Net loss for the quarter ended March 31, 2022 was $17.8
million, or $0.69 per share, as compared to a net loss of $12.7
million, or $0.53 per share for the corresponding quarter in 2021.
The increase in net loss was due to increased expenses associated
with the Company’s preclinical development costs of its nominated
candidates.
Financial Guidance
As a result of the debt capital facility and operations
relocation, as well as other initiatives to increase operational
efficiency, Oncorus now 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 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 selectively self-amplifying viral
RNA Immunotherapy Platforms.
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,
highlighted by our product candidates ONCR-021 and ONCR-788,
involves a highly innovative, novel combination of RNA and
oncolytic virus-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 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’ planned relocation of its operations; and Oncorus’ belief
that its current cash and investment resources will be sufficient
to fund its operations and capital expenditure requirements into
early. 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 ONCR-177, ONCR-021, ONCR-788 and
ONCR-GBM and obtain regulatory approval thereof; the impact of
COVID-19 on Oncorus’ operations and the timing and anticipated
results of its ongoing and planned clinical trials; 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, filed
with the Securities and Exchange Commission (“SEC”) on March 9,
2022 and Oncorus’ Quarterly Report on Form 10-Q for the quarter
ended March 31, 2022, to be filed with the SEC on May 4, 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 |
|
|
|
|
March 31, |
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
Operating
expenses: |
|
|
|
|
|
Research and
development |
$12,469 |
|
|
$8,447 |
|
|
|
General and
administrative |
|
5,349 |
|
|
|
4,222 |
|
|
Total operating
expenses |
|
17,818 |
|
|
|
12,669 |
|
|
Loss from
operations |
|
(17,818 |
) |
|
|
(12,669 |
) |
|
Other income
(expense): |
|
|
|
|
|
Other expense |
|
(38 |
) |
|
|
- |
|
|
|
Interest
income |
|
76 |
|
|
|
6 |
|
|
|
|
Total other income (expense),
net |
|
38 |
|
|
|
6 |
|
|
Net loss |
$(17,780 |
) |
|
$(12,663 |
) |
|
Comprehensive
loss: |
|
|
|
|
|
Net unrealized
loss on investments |
|
(26 |
) |
|
|
- |
|
|
Comprehensive
loss |
$(17,806 |
) |
|
$(12,663 |
) |
|
Net loss per share
- basic and diluted |
$(0.69 |
) |
|
$(0.53 |
) |
|
Weighted-average
number of common shares - basic and diluted |
|
25,865 |
|
|
|
24,009 |
|
|
|
|
|
|
|
|
|
Oncorus, Inc. |
|
Selected Condensed Consolidated Balance Sheet
Data |
|
(in thousands) |
|
(Unaudited) |
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
|
Cash and cash
equivalents |
$75,509 |
|
|
$100,752 |
|
|
Investments |
|
23,156 |
|
|
|
23,173 |
|
|
Working capital
(1) |
|
90,463 |
|
|
|
108,136 |
|
|
Right-of-use
asset |
|
40,183 |
|
|
|
45,218 |
|
|
Total assets |
|
176,568 |
|
|
|
201,587 |
|
|
Long term lease
liability |
|
49,921 |
|
|
|
50,388 |
|
|
Total
liabilities |
|
62,310 |
|
|
|
71,565 |
|
|
Total
stockholders' equity |
|
114,258 |
|
|
|
130,022 |
|
|
|
|
|
|
|
|
|
(1) Working
capital is defined as current assets less current liabilities |
|
|
|
|
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