– Two confirmed partial responses to
– Company focusing resources on advancement of SRF388 and SRF114, extending cash runway into Q2 2024 –
– Surface reports third quarter 2022 financial results –
– Management to host conference call to discuss SRF388 data and other corporate updates today at
“We are excited by the monotherapy activity seen with SRF388 in relapsed non-small cell lung cancer (NSCLC), an area of high unmet need globally,” said
Clinical Program Updates
SRF388, first-in-class antibody targeting IL-27
- In the ongoing study evaluating SRF388 as a monotherapy in NSCLC, two confirmed partial responses have been observed as of the data cut-off of
August 24, 2022 , in patients treated at or above the recommended Phase 2 dose (22% ORR (2/9)), which includes 100% (2/2) of patients with squamous NSCLC. Additionally, a patient with adenocarcinoma has experienced durable disease stabilization, ongoing for more than 56 weeks. All three of these patients had previous treatment with chemotherapy and with anti-PD-(L)1 agents. Based on these results, Surface has opened the second stage of the Simon’s 2-stage trial which is expected to enroll 40 patients with NSCLC in total.
- Surface has initiated a single-arm Phase 2 study evaluating SRF388 in combination with pembrolizumab in patients with NSCLC who have progressed after 1-3 prior lines of therapy, including chemotherapy and anti-PD-1 agents. The study is anticipated to enroll up to 40 patients with NSCLC.
- Surface anticipates sharing clinical results from the ongoing SRF388 studies in the first half of 2023.
- Surface has stopped enrollment in the renal cell carcinoma (RCC) study to focus efforts on NSCLC and HCC based on encouraging data seen in those indications.
SRF617, novel antibody targeting CD39
- Following a portfolio review, Surface made the strategic decision to pause the internal clinical development of SRF617, a novel antibody targeting CD39. In conjunction with this change, Surface is implementing an organizational restructuring that will result in a reduction of approximately 20% of its workforce.
- This change will enable the company to focus its resources on the advancement of SRF388 and SRF114, which Surface believes hold the greatest near-term potential to provide benefit to patients and drive value for shareholders.
- Management now projects that current cash and cash equivalents are sufficient to fund Surface into the second quarter of 2024.
- Surface is actively pursuing potential business development opportunities for SRF617.
SRF114, potential best-in-class antibody targeting CCR8
- In October, the
U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for SRF114, a potential best-in-class CCR8 inhibitor. Surface expects to enroll the first patient soon.
Third Quarter and Subsequent Corporate Highlights
- In October, Surface announced the publication of a study entitled, “Structural basis of activation and antagonism of receptor signaling mediated by Interleukin-27” in Cell Reports. The study was a collaborative research effort between the Unit for Structural Biology at the VIB-University of
Ghent Center for Inflammation Research andSurface Oncology . The research provides important structural evidence that the SRF388 antibody directly competes with the IL-27 receptor to prevent downstream signaling of the cytokine.
- In September, Surface presented new preclinical data demonstrating IL-27 induces a gene expression signature that has been associated with resistance to chemotherapy, radiotherapy, and checkpoint inhibition at the 10th Annual Cytokines Meeting of the
International Cytokine and Interferon Society (ICIS). The findings support the continued clinical investigation of SRF388 in multiple tumor types.
Corporate Update Conference Call and Webcast
Surface management will host a conference call and live webcast today,
To access the conference call by phone, please use this registration link, and you will be provided with dial-in details. A webcast re-play will be available in the investor relations section on the company's website shortly following the completion of the call.
Financial Results
As of
Research and development (R&D) expenses were
For the third quarter ended
About Surface Oncology
Surface Oncology is an immuno-oncology company developing next-generation antibody therapies focused on the tumor microenvironment. Its pipeline includes two wholly-owned programs; SRF388, a Phase 2 program which targets IL-27, and SRF114 which selectively depletes regulatory T cells in the tumor microenvironment via targeting CCR8. In addition, Surface has two partnerships with major pharmaceutical companies: a collaboration with Novartis targeting CD73 (NZV930; Phase 1) and a collaboration with GlaxoSmithKline targeting PVRIG (GSK4381562, formerly SRF813; Phase 1). Surface’s novel, investigational cancer immunotherapies are designed to achieve a clinically meaningful and sustained anti-tumor response and may be used alone or in combination with other therapies. For more information, please visit www.surfaceoncology.com.
Cautionary Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “will,” “would” or similar expressions, and the negative of those terms. These forward-looking statements are based on Surface Oncology’s management’s current beliefs and assumptions about future events and on information currently available to management.
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Surface Oncology’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks and uncertainties related to Surface Oncology’s ability to successfully develop SRF388, SRF114 and its other product candidates through current and future milestones or regulatory filings on the anticipated timeline, if at all; the therapeutic potential of Surface Oncology’s product candidates; the risk that results from preclinical studies or early clinical trials may not be representative of results from later or larger clinical trials; the risk that results from preliminary, interim or top-line data may not be representative of future or final data from the same studies; the risk that Surface Oncology’s product candidates, including SRF388 and SRF114, will not be successfully developed or commercialized; the risks related to Surface Oncology’s dependence on third-parties in connection with its manufacturing, clinical trials and preclinical studies; the risk that
Contact
(617) 865-3250
syoung@surfaceoncology.com
Selected Financial Information
(In thousands, except share and per share amounts)
(Unaudited)
| Three months ended |
Nine months ended |
||||||||||||||
| Statement of Operations Items | 2022 | 2021 | 2022 | 2021 | |||||||||||
| License-related revenue | $ | — | $ | 392 | $ | 30,000 | $ | 2,532 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 16,894 | 14,037 | 51,715 | 37,250 | |||||||||||
| General and administrative | 6,004 | 5,847 | 18,970 | 17,923 | |||||||||||
| Total operating expenses | 22,898 | 19,884 | 70,685 | 55,173 | |||||||||||
| Loss from operations | (22,898 | ) | (19,492 | ) | (40,685 | ) | (52,641 | ) | |||||||
| Interest and other income (expense), net | (342 | ) | (401 | ) | (1,569 | ) | (1,794 | ) | |||||||
| Net loss | (23,240 | ) | (19,893 | ) | (42,254 | ) | (54,435 | ) | |||||||
| Net loss per share — basic and diluted | $ | (0.39 | ) | $ | (0.44 | ) | $ | (0.78 | ) | $ | (1.25 | ) | |||
| Weighted average common shares outstanding — basic and diluted | 59,054,486 | 45,236,775 | 54,143,394 | 43,510,078 | |||||||||||
| Selected Balance Sheet Items: | |||||||
| Cash, cash equivalents and marketable securities | $ | 146,350 | $ | 154,149 | |||
| Total assets | 181,621 | 190,847 | |||||
| Accounts payable and accrued expenses | 12,235 | 14,639 | |||||
| Total stockholders’ equity | 112,819 | 118,900 | |||||
Source: Surface Oncology, Inc.