Oncorus Reports Second Quarter 2022 Financial Results and Provides Business Updates
August 04 2022 - 7:00AM
Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company
focused on driving innovation to transform outcomes for cancer
patients, today reported financial results for the second quarter
of 2022 and highlighted recent achievements and developments.
“In recent months, Oncorus has maintained momentum across our
portfolio of next-generation viral immunotherapies with ongoing
enrollment of patients in the ONCR-177 Phase 1 clinical trial and
continued IND-enabling studies for ONCR-021, our lead
self-amplifying vRNA/LNP program,” said Theodore (Ted) Ashburn,
M.D., Ph.D., President and Chief Executive Officer of Oncorus. “We
are preparing for the next phase of our growth as our pipeline
matures and as we operationalize our GMP-compliant manufacturing
facility by the end of this year. In our ongoing Phase 1 clinical
trial of ONCR-177, we remain on track to report initial data from
15 to 20 patients from our expansion cohort in combination with
Merck’s KEYTRUDA, along with additional surface lesion monotherapy
data by the end of 2022.”
Second Quarter 2022 and Recent Business
Highlights
- On track to report combination data and additional
monotherapy data for ONCR-177 in the second half of 2022.
Oncorus has completed enrollment in the dose expansion portion of
its Phase 1 open-label, multi-center clinical 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 initial surface lesion combination expansion data for
ONCR-177 administered with Merck’s KEYTRUDA and additional surface
lesion monotherapy expansion data expected in the second half of
2022.
- Presented preclinical data for ONCR-021 and ONCR-788
supporting the company’s 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 in mid-2023 and a subsequent IND submission for
ONCR-788.
- Announced debt capital facility with K2 HealthVentures
(K2HV) with $20 million funded at closing and planned relocation to
Andover, Massachusetts facility: In April 2022, Oncorus
entered into a loan and security agreement with K2HV, a
healthcare-focused specialty finance company, which provides
Oncorus with up to $45 million available in multiple tranches upon
the achievement of certain time-based, clinical and regulatory
milestones. Oncorus also announced plans to relocate all operations
to its facility in Andover, Massachusetts in the fourth quarter of
2022 to increase operational efficiency, allowing research, process
development and Good Manufacturing Practice (GMP)-compliant
manufacturing to occur all in one facility.
Second Quarter 2022 Financial Results
- Cash and cash equivalents and investments totaled $100.2
million as of June 30, 2022 compared to $98.7 million as of March
31, 2022.
- Research and development expenses for the quarter ended June
30, 2022 were $12.5 million compared to $10.7 million for the
corresponding quarter in 2021. The increase was primarily
attributable to increased headcount, which drove higher employee
compensation and 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 June
30, 2022 were $6.2 million compared to $4.9 million for the
corresponding quarter in 2021. The increase was primarily
attributable to increased headcount, which drove higher employee
compensation and stock-based compensation, as well as increased
rent expense related to the company’s manufacturing facility.
- Net loss for the quarter ended June 30, 2022 was $19.1 million,
or $0.74 per share, as compared to a net loss of $15.5 million, or
$0.60 per share for the corresponding quarter in 2021.
Financial Guidance
Oncorus 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 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 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 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’
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 2024.
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 its product candidates and obtain
regulatory approval thereof; the adequacy of Oncorus’ existing
capital resources and availability of financing on commercially
reasonable terms; 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 impact of COVID-19 on Oncorus’
operations and the timing and anticipated results of its ongoing
and planned clinical trials; 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,
filed with the SEC on May 4, 2022, and Oncorus’ Quarterly Report on
Form 10-Q for the quarter ended June 30, 2022, to be filed with the
SEC on or about August 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 |
|
Six Months Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
$ |
12,480 |
|
|
$ |
10,660 |
|
|
$ |
24,949 |
|
|
$ |
19,107 |
|
|
General and
administrative |
|
6,161 |
|
|
|
4,889 |
|
|
|
11,510 |
|
|
|
9,111 |
|
Total operating
expenses |
|
18,641 |
|
|
|
15,549 |
|
|
|
36,459 |
|
|
|
28,218 |
|
Loss from
operations |
|
(18,641 |
) |
|
|
(15,549 |
) |
|
|
(36,459 |
) |
|
|
(28,218 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Other expense |
|
(33 |
) |
|
|
- |
|
|
|
(71 |
) |
|
|
- |
|
|
Interest
expense |
|
(591 |
) |
|
|
- |
|
|
|
(591 |
) |
|
|
- |
|
|
Interest
income |
|
174 |
|
|
|
21 |
|
|
|
250 |
|
|
|
27 |
|
|
|
Total other income (expense),
net |
|
(450 |
) |
|
|
21 |
|
|
|
(412 |
) |
|
|
27 |
|
Net
loss |
$ |
(19,091 |
) |
|
$ |
(15,528 |
) |
|
$ |
(36,871 |
) |
|
$ |
(28,191 |
) |
Comprehensive
loss: |
|
|
|
|
|
|
|
|
Net unrealized
loss on investments |
|
(1 |
) |
|
|
- |
|
|
|
(41 |
) |
|
|
- |
|
Comprehensive
loss |
$ |
(19,091 |
) |
|
$ |
(15,528 |
) |
|
$ |
(36,912 |
) |
|
$ |
(28,191 |
) |
Net loss per share
- basic and diluted |
$ |
(0.74 |
) |
|
$ |
(0.60 |
) |
|
$ |
(1.43 |
) |
|
$ |
(1.13 |
) |
Weighted-average
number of common shares |
|
25,883 |
|
|
|
25,684 |
|
|
|
25,874 |
|
|
|
24,851 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncorus, Inc. |
|
|
|
Selected Condensed Consolidated Balance Sheet
Data |
|
|
|
(in thousands) |
|
|
|
(Unaudited) |
|
|
|
|
|
|
June 30,2022 |
|
December 31,2021 |
|
|
|
|
Cash and cash
equivalents |
$ |
84,797 |
|
|
$ |
100,752 |
|
|
|
|
|
Investments |
|
15,442 |
|
|
|
23,173 |
|
|
|
|
|
Working capital
(1) |
|
86,748 |
|
|
|
108,136 |
|
|
|
|
|
Right-of-use
asset |
|
39,673 |
|
|
|
45,218 |
|
|
|
|
|
Total assets |
|
182,540 |
|
|
|
201,587 |
|
|
|
|
|
Debt, net of debt
discount and issuance fees |
|
19,078 |
|
|
|
- |
|
|
|
|
|
Long term lease
liability |
|
49,269 |
|
|
|
50,388 |
|
|
|
|
|
Total
liabilities |
|
84,532 |
|
|
|
71,565 |
|
|
|
|
|
Total
stockholders' equity |
|
98,008 |
|
|
|
130,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Working
capital is defined as current assets less current liabilities |
|
|
|
|
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