Oncorus Reports Third Quarter 2020 Financial Results and Provides Business Highlights
-- Initiated Phase 1 clinical trial of lead viral immunotherapy candidate, ONCR-177, for the treatment of solid tumors --
-- Announced clinical trial collaboration with Merck to evaluate combination of ONCR-177 with KEYTRUDA® (pembrolizumab) as part of ongoing Phase 1 clinical trial --
“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
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 $15.00per share, raised $98.4 millionin 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,
Oncorusinitiated 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. Oncorusanticipates 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,
Oncorusannounced a clinical trial collaboration and supply agreement with Merck, known as MSD outside of the United Statesand 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.
Oncoruscontinues 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,
Oncorusis pursuing ONCR-GBM to specifically target brain cancer, including glioblastoma multiforme (GBM). Oncorusis 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. Oncorusplans to nominate its ONCR-GBM clinical candidate in the second half of 2021.
Third Quarter Financial Results
- Cash and cash equivalents were
$54.0 millionas of September 30, 2020, excluding the proceeds from the Company’s initial public offering in October 2020, compared to $45.3 millionas of December 31, 2019.
- Research and development expenses for the quarter ended
September 30, 2020were $6.9 millioncompared to $6.2 millionfor 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, 2020were $2.0 millioncompared to $1.5 millionfor 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, 2020was an expense of $10.6 millioncompared to income of $0.2 millionfor the quarter ended September 30, 2019. Other expense in 2020 included a non-cash charge of $10.6 millionrelated 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, 2020was $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.
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.
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
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.
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|(in thousands, except share and per share data)|
|Three Months Ended||Nine Months Ended|
|Research and development||$||6,927||$||6,221||$||19,560||$||18,183|
|General and administrative||1,973||1,513||6,032||3,978|
|Total operating expenses||8,900||7,734||25,592||22,161|
|Loss from operations||(8,900||)||(7,734||)||(25,592||)||(22,161||)|
|Other income (expense):|
|Change in fair value of Series B tranche rights||(10,631||)||-||(11,256||)||-|
|Total other income (expense), net||(10,631||)||161||(11,140||)||324|
|Net loss and comprehensive loss||$||(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||)||$||(25.48||)|
|Weighted-average number of common shares - basic and diluted||1,030||946||1,010||920|
|Selected Condensed Consolidated Balance Sheet Data|
|Cash and cash equivalents||$||54,019||$||45,286|
|Working capital (1)||50,463||40,963|
|Series B tranche rights liability||-||1,876|
|Redeemable convertible preferred stock||173,888||116,632|
|Total stockholders' deficit||$||(118,257||)||$||(74,297||)|
|(1) Working capital is defined as current assets less current liabilities|
Source: Oncorus, Inc.