Oncorus Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Highlights
March 10 2021 - 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 2020
financial results and provided business highlights.
“2020 was a year of significant evolution for Oncorus as we
successfully transitioned to a clinical-stage and publicly-traded
company,” said Theodore (Ted) Ashburn, M.D., Ph.D., President and
Chief Executive Officer of Oncorus. “In addition to moving our lead
viral immunotherapy candidate, ONCR-177, into a clinical trial, we
continued to advance multiple pipeline candidates across our
oncolytic Herpes Simplex Virus (oHSV) and Synthetic Virus
Platforms. We also began to plan operational and manufacturing
scale-up to support our anticipated growth in the coming
years.”
Dr. Ashburn continued, “Bolstered by a strong cash position, we
anticipate multiple milestones in 2021 that will further advance
Oncorus’ leadership in the viral immunotherapy space. These include
the initial interim data readout from our ongoing ONCR-177 clinical
trial, the nomination of our first intravenously administered
synthetic virus clinical candidates as well as our second
intratumorally administered oHSV clinical candidate, and the
completion of the first buildout phase of our GMP clinical
manufacturing facility. We look forward to continued growth
throughout 2021, driven by our mission to realize the full promise
of viral immunotherapy for cancer patients.”
Oncorus anticipates reporting interim data from its ongoing
Phase 1 clinical trial of its lead oHSV-based clinical candidate
ONCR-177 in patients with solid tumor indications in the second
half of 2021 through the second half of 2022. The company plans to
nominate its first synthetic virus clinical candidates,
coxsackievirus A21 and Seneca Valley Virus programs, in the first
half of 2021 and its second oHSV clinical candidate, which will
specifically target brain cancer, including glioblastoma
multiforme, in the second half of 2021.
Fourth Quarter and Full Year 2020 and Recent
Highlights
Recent Highlights
- Recently completed public
offering of common stock. In February 2021, Oncorus
completed an underwritten public offering of common stock, at a
public offering price of $19.00 per share, raising $57.0 million in
aggregate gross proceeds.
- 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 studies 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. Oncorus plans to continue partnering with
contract manufacturing organizations to provide additional support
and capacity. The company expects to employ up to 100 Oncorus team
members at the site.
- Announced publication of ONCR-177 preclinical data
demonstrating potent and durable antitumor activity. In
January 2021, Oncorus announced the recent publication of
preclinical data supporting the clinical development of ONCR-177.
In the paper, entitled, “ONCR-177, an Oncolytic HSV-1 Designed to
Potently Activate Systemic Antitumor Immunity” (Haines, et al.,
2020), published online in the journal Cancer
Immunology Research, ONCR-177 demonstrated potent and durable
antitumor activity in multiple immune-competent tumor models. The
preclinical activity of ONCR-177 was shown to be driven by Oncorus’
unique combination of five complementary immunomodulatory transgene
payloads in addition to its retention of γ34.5. A herpes simplex
virus 1 (HSV-1) gene, γ34.5 allows the virus to replicate in the
presence of host antiviral immune responses.
Fourth Quarter and Full Year 2020 Highlights
- Appointed Steve Harbin as Chief Operating Officer (COO)
and Chief of Staff. In December 2020, Oncorus appointed
Steve Harbin as COO and Chief of Staff, to lead planning and
execution of its anticipated operational and manufacturing
scale-up. Mr. Harbin brings more than 30 years of diverse
operational experience in biotech, pharmaceuticals and in-vitro
diagnostics. His experience includes serving in several executive
committee roles at Moderna, Inc. for six years, where he was a key
driver of the company’s successful growth strategy, overseeing
clinical and non-clinical manufacturing operations, supply chain,
facilities and human resources. Previously Mr. Harbin served as
Senior Vice President, Global Operations for France-based
bioMérieux SA, and also held multiple leadership roles within Eli
Lilly and Company globally.
- Expanded Board of Directors with appointment of Scott
Canute. In December 2020, Oncorus expanded its Board with
the appointment of Scott Canute. Mr. Canute has nearly 40 years of
broad experience in the biopharmaceutical industry, including
leading global manufacturing and operations strategy and execution
for Genzyme Corporation and Eli Lilly and Company.
- Completed initial public
offering. In October 2020, Oncorus completed the
initial public offering of shares of its common stock at a public
offering price of $15.00 per share, and raised $98.4 million in
aggregate gross proceeds, including shares sold to the underwriters
pursuant to a partial exercise of their option to purchase
additional shares. On October 2, 2020, Oncorus’ common stock
commenced trading on the Nasdaq Global Market under the ticker
symbol “ONCR”.
- Publication of preclinical
data characterizing ONCR-177’s safety strategies. In
September 2020, ONCR-177’s safety strategies and their ability to
enhance oHSV tolerability without impeding potency were
characterized in a paper published in Molecular Therapy on
ONCR-159, the unarmed version of ONCR-177, titled, “Design of an
Interferon-Resistant Oncolytic HSV-1 Incorporating Redundant Safety
Modalities for Improved Tolerability.” (Kennedy et al., 2020).
Oncorus’ oHSV platform incorporates two complementary and
proprietary safety approaches, including a microRNA attenuation
strategy to allow unencumbered viral replication in tumor cells
while preventing replication in healthy tissues, and engineered
proprietary mutations into UL37 to eliminate the virus’ ability to
transport, replicate and establish latency inside neurons.
- Announced clinical trial
collaboration with Merck. In July 2020, Oncorus entered
into a clinical trial collaboration and supply agreement with Merck
(NYSE:MRK), known as MSD outside of the United States and Canada,
through a subsidiary, to evaluate the combination of ONCR-177 with
KEYTRUDA® (pembrolizumab), as part of the ongoing Phase 1 clinical
trial of ONCR-177 in adult patients with advanced and/or refractory
cutaneous, subcutaneous or metastatic nodal solid tumors.
- Initiated Phase 1 clinical
trial of ONCR-177. In June 2020, Oncorus initiated a Phase
1 clinical trial of its lead product candidate, ONCR-177, an
intratumorally 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 and to determine the recommended Phase 2 dose, as well as
its 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 anticipates reporting
interim data from the Phase 1 clinical trial in the second half of
2021 through the second half of 2022.
Fourth Quarter Financial Results
- Cash and cash equivalents were $130.3
million as of December 31, 2020 compared to $45.3 million as of
December 31, 2019.
- Research and development expenses for
the quarter ended December 31, 2020 were $7.6 million compared to
$5.9 million for the corresponding period in 2019. The increase in
research and development expenses was mainly attributable to
increases in clinical trial costs for the company’s Phase 1
clinical trial as well as increased personnel-related expenses
driven by increased headcount.
- General and administrative expenses
for the quarter ended December 31, 2020 were $4.0 million compared
to $3.1 million for the corresponding period in 2019. The increase
in general and administrative expenses was primarily attributable
to increases in personnel-related expenses driven by increased
headcount as well as increased costs associated with the Company’s
transition to a public company in the fourth quarter of
2020.
- Net loss attributable to common stockholders for the quarter
ended December 31, 2020 was $(11.8) million, or $(0.56) per share,
compared to a net loss attributable to common stockholders of
$(11.5) million, or $(11.78) per share for the same period in 2019.
The share and loss per share amounts in the fourth quarter of 2020
reflect the impact of the company’s IPO, which closed in October
2020.
Financial Guidance
Based upon its current operating plans and cash and cash
equivalents at December 31, 2020, plus the net proceeds from the
public offering of common stock in February 2021, the company
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 Virus 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 Virus 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, to be 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: |
Media Contact: |
Alan Lada |
Liz Melone |
Solebury Trout |
liz.melone@oncorus.com |
617-221-8006 |
|
alada@soleburytrout.com |
|
Oncorus, Inc. |
|
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
|
(in thousands, except per share data) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
|
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
$ |
7,593 |
|
|
$ |
5,864 |
|
|
$ |
27,153 |
|
|
$ |
24,047 |
|
|
General and
administrative |
|
3,968 |
|
|
|
3,141 |
|
|
|
10,000 |
|
|
|
7,119 |
|
Total operating
expenses |
|
11,561 |
|
|
|
9,005 |
|
|
|
37,153 |
|
|
|
31,166 |
|
Loss from
operations |
|
(11,561 |
) |
|
|
(9,005 |
) |
|
|
(37,153 |
) |
|
|
(31,166 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Change in fair
value of Series B tranche rights |
|
- |
|
|
|
- |
|
|
|
(11,256 |
) |
|
|
- |
|
|
Other expense |
|
(11 |
) |
|
|
(40 |
) |
|
|
(33 |
) |
|
|
(47 |
) |
|
Interest
income |
|
5 |
|
|
|
178 |
|
|
|
143 |
|
|
|
509 |
|
|
Total other income (expense), net |
|
(6 |
) |
|
|
138 |
|
|
|
(11,146 |
) |
|
|
462 |
|
Net loss and
comprehensive loss |
$ |
(11,567 |
) |
|
$ |
(8,867 |
) |
|
$ |
(48,299 |
) |
|
$ |
(30,704 |
) |
Accretion of
discount and dividends on redeemable convertible preferred
stock |
|
(229 |
) |
|
|
(2,678 |
) |
|
|
(8,527 |
) |
|
|
(4,287 |
) |
Net loss
attributable to common stockholders |
$ |
(11,796 |
) |
|
$ |
(11,545 |
) |
|
$ |
(56,826 |
) |
|
$ |
(34,991 |
) |
Net loss per share
- basic and diluted |
$ |
(0.56 |
) |
|
$ |
(11.78 |
) |
|
$ |
(9.35 |
) |
|
$ |
(37.42 |
) |
Weighted-average
number of common shares - basic and diluted |
|
21,126 |
|
|
|
980 |
|
|
|
6,080 |
|
|
|
935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncorus, Inc. |
|
Selected Condensed Consolidated Balance Sheet
Data |
|
(in thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
December 31, 2020 |
|
December 31, 2019 |
Cash and cash
equivalents |
|
|
|
|
$ |
130,305 |
|
|
$ |
45,286 |
|
Working capital
(1) |
|
|
|
|
|
127,407 |
|
|
|
40,963 |
|
Right-of-use asset
(2) |
|
|
|
|
|
41,372 |
|
|
|
- |
|
Total assets |
|
|
|
|
|
182,263 |
|
|
|
50,826 |
|
Long term lease
liability (2) |
|
|
|
|
|
41,615 |
|
|
|
- |
|
Total
liabilities |
|
|
|
|
|
47,599 |
|
|
|
8,491 |
|
Redeemable
convertible preferred stock |
|
|
|
|
|
- |
|
|
|
116,632 |
|
Total
stockholders' equity (deficit) |
|
|
|
|
$ |
134,664 |
|
|
$ |
(74,297 |
) |
|
|
|
|
|
|
|
|
|
|
(1) Working capital is defined as current assets less current
liabilities(2) Reflects the adoption of ASC 842, Leases, as of
January 1, 2020 resulting in capitalization of right of use assets
and a corresponding liability for the Company’s operating
leases
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