Oncorus Reports Third Quarter 2020 Financial Results and Provides Business Highlights
November 11 2020 - 7:00AM
Oncorus, Inc. (Nasdaq:ONCR), a viral immunotherapies company
focused on driving innovation to transform outcomes for cancer
patients, today reported third quarter 2020 financial results and
highlighted recent achievements and developments.
“We’ve made significant strides thus far in 2020 advancing our
mission to realize the full promise of viral immunotherapy for
cancer patients, including the commencement of a Phase 1 clinical
trial for our lead clinical candidate, ONCR-177, as well as
entering into a clinical trial collaboration with Merck to study
ONCR-177 in combination with KEYTRUDA as part of the trial,” said
Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive
Officer of Oncorus.
Dr. Ashburn further commented, “Bolstered by the completion of
our IPO last month and a strong cash position, we continue to
progress our pipeline of intratumorally and intravenously
administered viral immunotherapies across our oncolytic Herpes
Simplex Virus (oHSV) and Synthetic Virus Platforms. Our goal is to
treat a broad spectrum of cancers to bring the full potential of
this therapeutic class to as many patients as possible.”
Third Quarter 2020 and
Recent Highlights
- Completed
initial
public
offering (IPO) in
October. Oncorus’s common stock
commenced trading on the Nasdaq Global Market under the ticker
symbol “ONCR” on October 2, 2020. The IPO, at a public offering
price of $15.00 per share, raised $98.4 million in aggregate gross
proceeds, including shares sold to the underwriters pursuant to the
partial exercise of their option to purchase additional
shares.
- Initiated Phase
1 clinical trial of
ONCR-177. In June, 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.
- Announced
clinical
trial
collaboration with
Merck. In July, Oncorus announced a clinical trial
collaboration and supply agreement with Merck, known as MSD outside
of the United States and Canada, through a subsidiary, to evaluate
the combination of ONCR-177 with KEYTRUDA, 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.
-
Continued to
advance lead Synthetic
Virus Platform programs toward clinical candidate
nominations.
Oncorus continues to advance its lead synthetic, intravenously (IV)
administered viral immunotherapy programs based on the
coxsackievirus A21 (CVA21) and the Seneca Valley Virus and 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
oncology patients because it allows for all tumors in a patient,
including the micro-metastases that are sometimes difficult to
detect and treat, to be treated directly. In addition, it allows
for the potential treatment of certain tumors, such as those of the
lung, that are less amenable to repeat intratumoral injection of
anti-cancer therapies for both safety and feasibility reasons.
Oncorus’s Synthetic Virus Platform includes its novel lipid
nanoparticle delivery strategy designed to overcome the challenges
caused by neutralizing antibodies that have limited the efficacy of
previous industry efforts to treat tumors utilizing IV
administration of CVA21.
-
Continued to
advance 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). Oncorus is
utilizing its knowledge of microRNA expression to engineer a
microRNA attenuation strategy to protect healthy brain tissue and
select a combination of payloads that 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.
Third Quarter Financial
Results
- Cash and cash equivalents were $54.0
million as of September 30, 2020, excluding the proceeds from the
Company’s initial public offering in October 2020, compared to
$45.3 million as of December 31, 2019.
- Research and development expenses for
the quarter ended September 30, 2020 were $6.9 million compared to
$6.2 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 September 30, 2020 were $2.0 million compared
to $1.5 million for the corresponding period in 2019. The
increase in general and administrative expenses was primarily
attributable to increases in audit and legal activity and related
expenses as well as personnel-related expenses driven by increased
headcount.
- Other income (expense), net, for the
quarter ended September 30, 2020 was an expense of $10.6 million
compared to income of $0.2 million for the quarter ended September
30, 2019. Other expense in 2020 included a non-cash charge of $10.6
million related to an increase in the fair market value of the
Company’s Series B preferred stock tranche rights liability that
was settled in September 2020, upon the closing of the second
tranche of the Series B financing, which occurred prior to the
IPO.
- Net loss attributable to common
stockholders for the quarter ended September 30, 2020 was $22.4
million, or $(21.73) per share, compared to a net loss attributable
to common stockholders of $9.2 million, or $(9.67) per share for
the same period in 2019. The share and loss per share amounts do
not 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, including the net proceeds from the IPO, the Company
expects to have sufficient capital to fund its operating expenses
and capital expenditure requirements into 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’s 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; and its belief that its
current cash resources will be sufficient to fund its operations
into 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’s 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’s 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’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2020, to be filed with the Securities and Exchange Commission on
November 12, 2020, 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’s website at
http://investors.oncorus.com.
Any forward-looking statements represent Oncorus’s 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 share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
6,927 |
|
|
$ |
6,221 |
|
|
$ |
19,560 |
|
|
$ |
18,183 |
|
General and administrative |
|
1,973 |
|
|
|
1,513 |
|
|
|
6,032 |
|
|
|
3,978 |
|
Total operating expenses |
|
8,900 |
|
|
|
7,734 |
|
|
|
25,592 |
|
|
|
22,161 |
|
Loss from operations |
|
(8,900 |
) |
|
|
(7,734 |
) |
|
|
(25,592 |
) |
|
|
(22,161 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Change in fair value of Series B tranche rights |
|
(10,631 |
) |
|
|
- |
|
|
|
(11,256 |
) |
|
|
- |
|
Other expense |
|
(2 |
) |
|
|
(3 |
) |
|
|
(22 |
) |
|
|
(7 |
) |
Interest income |
|
2 |
|
|
|
164 |
|
|
|
138 |
|
|
|
331 |
|
Total other income (expense), net |
|
(10,631 |
) |
|
|
161 |
|
|
|
(11,140 |
) |
|
|
324 |
|
Net loss and comprehensive
loss |
$ |
(19,531 |
) |
|
$ |
(7,573 |
) |
|
$ |
(36,732 |
) |
|
$ |
(21,837 |
) |
Accretion of discount and
dividends on redeemable convertible preferred stock |
|
(2,848 |
) |
|
|
(1,578 |
) |
|
|
(8,298 |
) |
|
|
(1,609 |
) |
Net loss attributable to
common stockholders |
$ |
(22,379 |
) |
|
$ |
(9,151 |
) |
|
$ |
(45,030 |
) |
|
$ |
(23,446 |
) |
Net loss per share - basic and
diluted |
$ |
(21.73 |
) |
|
$ |
(9.67 |
) |
|
$ |
(44.58 |
) |
|
$ |
(25.48 |
) |
Weighted-average number of
common shares - basic and diluted |
|
1,030 |
|
|
|
946 |
|
|
|
1,010 |
|
|
|
920 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncorus, Inc. |
Selected Condensed Consolidated Balance Sheet
Data |
(in thousands) |
(Unaudited) |
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
Cash and cash equivalents |
|
|
|
|
$ |
54,019 |
|
|
$ |
45,286 |
|
Working capital (1) |
|
|
|
|
|
50,463 |
|
|
|
40,963 |
|
Total assets |
|
|
|
|
|
62,059 |
|
|
|
50,826 |
|
Series B tranche rights
liability |
|
|
|
|
|
- |
|
|
|
1,876 |
|
Total liabilities |
|
|
|
|
|
6,428 |
|
|
|
8,491 |
|
Redeemable convertible
preferred stock |
|
|
|
|
|
173,888 |
|
|
|
116,632 |
|
Total stockholders'
deficit |
|
|
|
|
$ |
(118,257 |
) |
|
$ |
(74,297 |
) |
|
|
|
|
|
|
|
|
(1) Working
capital is defined as current assets less current liabilities |
|
|
|
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