Oncorus Reports First Quarter 2021 Financial Results and Provides Business Highlights
May 04 2021 - 7:00AM
Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company
focused on driving innovation to transform outcomes for cancer
patients, today reported first quarter 2021 financial results and
highlighted recent achievements and developments.
“We began 2021 with strong momentum, announcing the buildout of
our GMP manufacturing facility which is now well underway, and we
continue to advance our ambitious goals on behalf of cancer
patients,” said Theodore (Ted) Ashburn, M.D., Ph.D., President and
Chief Executive Officer of Oncorus.
Dr. Ashburn further commented, “We continue to enroll patients
in a Phase 1 clinical trial of ONCR-177, our lead oncolytic Herpes
Simplex Virus (oHSV) clinical candidate, and expect initial interim
data later this year. We also anticipate nominating our first two
synthetic viral RNA (vRNA) immunotherapy candidates in the first
half of 2021. These candidates are comprised of vRNA coding for
oncolytic viruses encapsulated within lipid nanoparticles, or LNPs
– proprietary technologies developed by the Oncorus team. We have
designed this novel approach to enable the systemic, repeat
intravenous (IV) administration of viral immunotherapies, the
so-called ‘holy grail’ of this modality, to date unattainable.
We’re excited to introduce this breakthrough approach and discuss
these candidates in more detail at an upcoming virtual investor
event.”
First Quarter 2021 and Recent Highlights
- Enrolling Phase 1 clinical
trial of ONCR-177. Oncorus is currently enrolling a Phase
1 clinical trial of its lead product candidate, ONCR-177, an
intratumorally (iTu) administered oHSV viral immunotherapy being
developed for multiple solid tumor indications. The Phase 1
open-label, multi-center, dose escalation and expansion clinical
trial is designed to evaluate the safety and tolerability of
ONCR-177. The trial will determine the recommended Phase 2 dose, as
well as investigate ONCR-177’s preliminary anti-tumor activity,
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. Oncorus
has an ongoing clinical trial collaboration with Merck involving
KEYTRUDA and anticipates reporting interim data from the Phase 1
trial in the second half of 2021 through the second half of
2022.
- Advancing lead Synthetic
vRNA Immunotherapy Platform programs toward clinical candidate
nomination. Oncorus continues to advance its lead
synthetic, IV administered vRNA immunotherapy programs based on the
Coxsackievirus A21 (CVA21) and the Seneca Valley Virus (SVV). The
company expects to nominate clinical candidates for both programs
in the first half of 2021. IV administration of viral
immunotherapies is an attractive approach for improving the
standard of care for many cancer patients because it allows for all
tumors, including micro-metastases, to be directly treated. In
addition, it allows for the potential treatment of certain tumors,
such as those of the lung, that are less amenable to repeat iTu
injection of anti-cancer therapies due to safety and feasibility
considerations. Oncorus’ Synthetic vRNA Immunotherapy Platform
includes a novel LNP delivery strategy designed to overcome the
challenges caused by neutralizing antibodies, which have limited
the efficacy of previous industry efforts to treat tumors utilizing
IV administration of OVs.
- Advancing second oHSV viral
immunotherapy candidate, ONCR-GBM. 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
select a combination of payloads intended to address the specific
drivers of immune suppression in brain cancer. Oncorus plans to
nominate its ONCR-GBM clinical candidate in the second half of
2021.
- Announced buildout of Good
Manufacturing Practice (GMP) viral immunotherapy clinical
manufacturing facility. In January
2021, Oncorus announced the signing of a 15-year lease to build a
state-of-the-art, 88,000 square foot GMP viral immunotherapy
clinical manufacturing facility in Andover, Mass. The facility is
intended to provide a comprehensive solution for Oncorus’
Chemistry, Manufacturing and Controls (CMC) development needs,
enabling the manufacture, quality, control and supply of
clinical-grade viral immunotherapies for investigational new drug
(IND)-enabling and clinical studies. Oncorus anticipates the first
phase of the facility’s buildout will be completed in late 2021,
including process development and quality control, with GMP
multi-product manufacturing capabilities and full operation
commencing in early 2023.
- Completed follow-on public
offering. In February 2021, Oncorus
completed an underwritten public offering of common stock, at a
price of $19.00 per share, raising $57.0 million in aggregate gross
proceeds.
First Quarter Financial Results
- Cash and cash equivalents were $172.6
million as of March 31, 2021 compared to $130.3 million as of
December 31, 2020.
- Research and development expenses for
the quarter ended March 31, 2021 were $8.4 million compared to $5.9
million for the corresponding quarter in 2020. The increase in
research and development expenses was mainly attributable to
increased rent expense related to the Company’s new manufacturing
facility, increased personnel-related expenses, including
stock-based compensation, driven by increased headcount and
increased clinical trial costs for the Company’s ongoing Phase 1
clinical trial of ONCR-177.
- General and administrative expenses
for the quarter ended March 31, 2021 were $4.2 million compared to
$2.1 million for the corresponding quarter in 2020. The increase in
general and administrative expenses was primarily attributable to
increases in personnel-related expenses, including stock-based
compensation, driven by increased compensation and increased
headcount and increased costs, such as insurance expense and
professional and consultant expenses, related to operating as a
public company.
- Net loss attributable to common
stockholders for the quarter ended March 31, 2021 was $12.7
million, or $0.53 per share, compared to a net loss attributable to
common stockholders of $10.6 million, or $10.59 per share for the
same quarter in 2020. The share and loss per share amounts in the
first quarter of 2021 reflect the impact of the company’s 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 and
intravenously administered viral immunotherapies for multiple
indications with significant unmet needs 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 potency
without sacrificing safety, including greater capacity to encode
transgenes to drive systemic immunostimulatory activity, retention
of full replication competency to enable high tumor-killing
potency, and orthogonal safety strategies to restrict viral
activity to tumor cells. Our lead program, ONCR-177, is designed to
be directly administered into a tumor, resulting in high local
concentrations of the therapeutic agent, as well as low systemic
exposure to the therapy, which we believe could potentially limit
systemic toxicities. 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; Oncorus’ expectations
regarding upcoming milestones for its other potential product
candidates, including the timing for nomination of candidates from
its two Synthetic vRNA Immunotherapy Platform development programs
and its second oHSV Platform program, ONCR-GBM; expectations
regarding the buildout timeline of its viral immunotherapy clinical
manufacturing facility and its belief that its current cash
resources will be sufficient to fund its operations 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 a clinical trial may not be predictive
of future results in connection with future clinical trials;
Oncorus’ ability to successfully demonstrate the safety and
efficacy of ONCR-177 and obtain regulatory approval; 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. No representations or
warranties (expressed or implied) are made about the accuracy of
any such forward-looking statements.
Investor Contact:Alan LadaSolebury
Trout617-221-8006alada@soleburytrout.com |
Media Contact:Liz
Meloneliz.melone@oncorus.com |
Oncorus, Inc. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(in thousands, except per share data) |
(Unaudited) |
|
|
Three Months Ended |
|
March 31, |
|
|
2021 |
|
|
|
2020 |
|
Operating expenses: |
|
|
|
Research and development |
$ |
8,447 |
|
|
$ |
5,892 |
|
General and administrative |
|
4,222 |
|
|
|
2,052 |
|
Total operating expenses |
|
12,669 |
|
|
|
7,944 |
|
Loss from operations |
|
(12,669 |
) |
|
|
(7,944 |
) |
Other income (expense): |
|
|
|
Other expense |
|
- |
|
|
|
(11 |
) |
Interest income |
|
6 |
|
|
|
128 |
|
Total other income (expense), net |
|
6 |
|
|
|
117 |
|
Net loss and comprehensive
loss |
$ |
(12,663 |
) |
|
$ |
(7,827 |
) |
Accretion of discount and
dividends on redeemable convertible preferred stock |
|
- |
|
|
|
(2,725 |
) |
Net loss attributable to
common stockholders |
$ |
(12,663 |
) |
|
$ |
(10,552 |
) |
Net loss per share - basic and
diluted |
$ |
(0.53 |
) |
|
$ |
(10.59 |
) |
Weighted-average number of
common shares - basic and diluted |
|
24,009 |
|
|
|
996 |
|
|
|
|
|
|
|
|
|
Oncorus, Inc. |
Selected Condensed Consolidated Balance Sheet
Data |
(in thousands) |
(Unaudited) |
|
|
March 31, |
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
Cash and cash equivalents |
$ |
172,622 |
|
|
$ |
130,305 |
|
Working capital (1) |
|
168,763 |
|
|
|
127,407 |
|
Right-of-use asset |
|
40,847 |
|
|
|
41,372 |
|
Total assets |
|
225,107 |
|
|
|
182,263 |
|
Long term lease liability |
|
42,083 |
|
|
|
41,615 |
|
Total liabilities |
|
48,852 |
|
|
|
47,599 |
|
Total stockholders'
equity |
$ |
176,255 |
|
|
$ |
134,664 |
|
|
|
|
|
|
|
|
|
(1) Working capital is defined as current assets
less current liabilities
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