Oncorus Reports Second Quarter 2021 Financial Results and Provides Business Highlights
August 04 2021 - 7:00AM
Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company
focused on driving innovation to transform outcomes for cancer
patients, today reported second quarter 2021 financial results and
highlighted recent achievements and developments.
“We’re pleased that our Phase 1 clinical trial of ONCR-177, our
lead oHSV candidate, continues to enroll and progress as expected,
and we remain on track to report initial clinical data in the
fourth quarter of this year. ONCR-177 is unique among oHSVs in that
it retains the ability to resist interferon via retention of γ34.5
and is armed with five complementary immunomodulatory payloads in
order to drive systemic activity,” said Theodore (Ted) Ashburn,
M.D., Ph.D., President and Chief Executive Officer at Oncorus.
“This quarter, we also announced the nomination of our lead
Synthetic vRNA immunotherapy candidates, ONCR-021 and ONCR-788,
which we plan to investigate in multiple cancers, including those
of the lung. Our proprietary Synthetic vRNA Immunotherapy Platform
involves a novel combination of RNA- and viral immunotherapy-based
modalities. To date, we believe that neither of these modalities
has reached its full potential due to several well-established
challenges, which we believe we can overcome through our novel and
innovative approach and, in doing so, potentially create a new
pillar of therapy for cancer patients.”
Second Quarter 2021 and Recent Highlights
- Continued to progress Phase
1 clinical trial of ONCR-177. Oncorus continues to enroll
patients in a Phase 1 clinical trial of its lead oHSV 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 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 anticipates reporting initial interim
data from the Phase 1 trial in the fourth quarter of 2021.
- Announced nomination of its
first Synthetic vRNA immunotherapy clinical candidates, ONCR-021
and ONCR-788. In May 2021, Oncorus nominated its first
Synthetic vRNA immunotherapy clinical candidates, ONCR-021 and
ONCR-788. Oncorus’ pioneering IV-administered approach involves
encapsulating the genomes of RNA viruses known to kill cancer cells
(i.e., oncolytic viruses, or OVs) in a lipid nanoparticle (LNP),
creating a Synthetic vRNA immunotherapy. ONCR-021 encodes an
optimized strain of Coxsackievirus A21 (CVA21), and ONCR-788
encodes a modified version of the Seneca Valley Virus (SVV). Both
CVA21 and SVV have extensive clinical experience and favorable
safety profiles when administered IV. Oncorus’ novel Synthetic vRNA
approach holds the potential for IV-administration and avoids the
challenge of neutralizing antibodies seen in previous approaches
with IV-administered OVs. 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 other cancer treatments.Click here
to read a white paper published by Oncorus’ leadership on its
Synthetic vRNA Immunotherapy Platform and lead candidates and here
for the slide deck presented at Oncorus’ recent investor meeting.
Click here to view an animation depicting Oncorus’ novel Synthetic
vRNA immunotherapy approach.
- Continued to advance second
oHSV viral immunotherapy candidate, ONCR-GBM, toward candidate
nomination. 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
combination of payloads intended to address the specific drivers of
immune suppression in brain cancer.
- Progressed buildout of Good
Manufacturing Practice (GMP) viral immunotherapy clinical
manufacturing facility. Oncorus
continues to make progress building out its state-of-the-art,
88,000 square foot GMP viral immunotherapy clinical manufacturing
facility in Andover, Massachusetts. The facility, for which Oncorus
has signed a 15-year lease, 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. The company remains
on track to complete the first phase of the facility’s buildout in
2021, including process development and quality control, with GMP
multi-product manufacturing capabilities and full operation
expected to commence in the first half of 2023.
- Expanded Board of Directors
with two new appointments. Oncorus expanded its Board with
the appointments of Eric H. Rubin, M.D., and Barbara Yanni, in June
2021 and July 2021, respectively. Dr. Rubin currently serves as
Senior Vice President of Global Clinical Oncology at Merck, known
as MSD outside of the United States and Canada. Ms. Yanni was
formerly Vice President and Chief Licensing Officer at Merck, prior
to her retirement in 2014.
Second Quarter Financial Results
- Cash and cash equivalents were $159.9
million as of June 30, 2021 compared to $130.3 million as of
December 31, 2020.
- Research and development expenses for
the quarter ended June 30, 2021 were $10.7 million compared to $6.7
million for the corresponding quarter in 2020. The increase in
research and development expenses was mainly attributable to
increased personnel-related expenses, including stock-based
compensation, which was driven by increased headcount, 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 June 30, 2021 were $4.9 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 personnel-related expenses, including stock-based
compensation, which was driven by increased compensation and
increased headcount and other 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 June 30, 2021 was $15.5 million,
or $0.60 per share, compared to a net loss attributable to common
stockholders of $12.1 million, or $12.09 per share for the same
quarter in 2020. The share and net loss per share amounts in the
second 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
(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; the preclinical and
clinical development of ONCR-021 and ONCR-788, including
expectations regarding timing for filing INDs, as well as the
product candidates’ therapeutic potential and clinical benefits and
the utility and potential of Oncorus’ Synthetic vRNA Immunotherapy
Platform; Oncorus’ expectations regarding upcoming milestones for
its other potential product candidates, including the timing for
nomination of a candidate from its second oHSV Platform program,
ONCR-GBM; expectations regarding manufacturing capabilities
including the buildout timeline of Oncorus’ viral immunotherapy
clinical manufacturing facility; 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 and
efficacy of ONCR-177, ONCR-021 and ONCR-788 and obtain regulatory
approval; Oncorus’ ability to secure adequate quantities of viral
immunotherapies manufactured in accordance with regulatory
requirements; the expansion of Oncorus’ in-house manufacturing
capabilities; the adequacy of Oncorus’ cash resources and
availability of financing on commercially reasonable terms; 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 |
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Media Contact:Liz Meloneliz@scientpr.com |
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|
Oncorus, Inc. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(in thousands, except per share data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
10,660 |
|
|
$ |
6,741 |
|
|
$ |
19,107 |
|
|
$ |
12,633 |
|
General and administrative |
|
4,889 |
|
|
|
2,007 |
|
|
|
9,111 |
|
|
|
4,059 |
|
Total operating expenses |
|
15,549 |
|
|
|
8,748 |
|
|
|
28,218 |
|
|
|
16,692 |
|
Loss from operations |
|
(15,549 |
) |
|
|
(8,748 |
) |
|
|
(28,218 |
) |
|
|
(16,692 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Change in fair value of Series B tranche rights |
|
- |
|
|
|
(625 |
) |
|
|
- |
|
|
|
(625 |
) |
Other expense |
|
- |
|
|
|
(9 |
) |
|
|
- |
|
|
|
(20 |
) |
Interest income |
|
21 |
|
|
|
8 |
|
|
|
27 |
|
|
|
136 |
|
Total other income (expense), net |
|
21 |
|
|
|
(626 |
) |
|
|
27 |
|
|
|
(509 |
) |
Net loss and comprehensive
loss |
$ |
(15,528 |
) |
|
$ |
(9,374 |
) |
|
$ |
(28,191 |
) |
|
$ |
(17,201 |
) |
Accretion of discount and
dividends on redeemable convertible preferred stock |
|
- |
|
|
|
(2,725 |
) |
|
|
- |
|
|
|
(5,450 |
) |
Net loss attributable to
common stockholders |
$ |
(15,528 |
) |
|
$ |
(12,099 |
) |
|
$ |
(28,191 |
) |
|
$ |
(22,651 |
) |
Net loss per share - basic and
diluted |
$ |
(0.60 |
) |
|
$ |
(12.09 |
) |
|
$ |
(1.13 |
) |
|
$ |
(22.67 |
) |
Weighted-average number of
common shares - basic and diluted |
|
25,684 |
|
|
|
1,001 |
|
|
|
24,851 |
|
|
|
999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncorus, Inc. |
Selected Condensed Consolidated Balance Sheet
Data |
(in thousands) |
(Unaudited) |
|
|
June 30, 2021 |
|
|
December 31, 2020 |
Cash and cash equivalents |
$ |
159,920 |
|
|
$ |
130,305 |
|
Working capital (1) |
|
151,945 |
|
|
|
127,407 |
|
Right-of-use asset |
|
40,018 |
|
|
|
41,372 |
|
Total assets |
|
215,610 |
|
|
|
182,263 |
|
Long term lease liability |
|
42,234 |
|
|
|
41,615 |
|
Total liabilities |
|
52,978 |
|
|
|
47,599 |
|
Total stockholders'
equity |
|
162,632 |
|
|
|
134,664 |
|
|
|
|
|
|
|
|
|
(1) Working capital is defined as current assets
less current liabilities
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