SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
|(State or Other Jurisdiction||(Commission||(IRS Employer|
|of Incorporation)||File Number)||Identification No.)|
|(Address of principal executive offices)||(zip code)|
Registrant’s telephone number, including area code:
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of exchange
on which registered
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
|Item 2.02|| |
Results of Operations and Financial Condition.
On November 2, 2022, Surface Oncology, Inc. (the “Company”) announced Business Updates and Financial Results for the three and nine months ended September 30, 2022. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.
The information under this Item 2.02, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
|Item 8.01|| |
On November 2, 2022, the Company will hold a webcast to review data from its ongoing SRF388 Phase 1/1b clinical trial and other corporate updates. The corporate presentation that will be presented during the webcast is filed as Exhibit 99.2 to this Current Report on Form 8-K.
|Item 9.01|| |
|99.1||Press release issued by Surface Oncology, Inc., on November 2, 2022|
|99.2||Corporate Presentation of Surface Oncology, Inc., dated November 2, 2022|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Surface Oncology, Inc.|
|Date: November 2, 2022||By:|
|Chief Financial Officer|
Surface Oncology Announces Promising SRF388 Monotherapy Data in Non-Small Cell Lung Cancer (NSCLC), Opening Second Stage of Monotherapy Trial and NSCLC Pembrolizumab Combination Cohort
Two confirmed partial responses to SFR388 monotherapy treatment in squamous NSCLC;
third patient with NSCLC experienced durable disease stabilization for over a year
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 8:30 a.m. ET
CAMBRIDGE, Mass., November 2, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, today provided a corporate update and reported financial results for the third quarter of 2022.
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 Rob Ross, M.D., chief executive officer. Two patients with squamous NSCLC have had confirmed partial responses to monotherapy treatment. Both patients had progressed on multiple prior systemic treatments, including anti-PD-(L)1 antibodies and chemotherapy. In addition, a third patient with highly pretreated NSCLC experienced durable disease stabilization and has remained on study for over a year without progression. Based on these promising results in relapsed NSCLC, we have opened the second stage of our trial investigating SRF388 as a monotherapy, and we have treated our first patients in a new cohort to investigate SRF388 in combination with pembrolizumab in second to fourth line NSCLC. We look forward to sharing additional data from those trials in the first half of 2023.
Dr. Ross added, While we continue to believe SRF617 holds therapeutic potential in a variety of tumor types, we have made the strategic decision to pause internal development of that program and focus our efforts on SRF388 and SRF114. As a result, we are implementing a corresponding reduction in our workforce. The work done by our impressive team of scientists and clinicians was outstanding, but we believe it is in the best interest of patients and our shareholders to invest our resources where they can have the greatest potential impact in the near term. We are actively pursuing partnership opportunities to advance SRF617 outside of Surface.
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 Simons 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 and Surface 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, November 2, 2022, at 8:30 a.m. ET to discuss the SRF388 data and other corporate updates. Individuals interested in viewing the webcast may do so by registering via this webcast link or by visiting the Investor Relations section of the companys website at: www.surfaceoncology.com.
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 companys website shortly following the completion of the call.
As of September 30, 2022, cash, cash equivalents and marketable securities were $146.4 million, compared to $154.1 million on December 31, 2021. General and administrative (G&A) expenses were $6.0 million for the third quarter ended September 30, 2022, compared to $5.8 million for the same period in 2021. The increase primarily relates to personnel related costs from increased headcount. G&A expenses included $1.1 million in stock-based compensation expense for the third quarter ended September 30, 2022.
Research and development (R&D) expenses were $16.9 million for the third quarter ended September 30, 2022, compared to $14.0 million for the same period in 2021. The increase was primarily driven by expenses incurred for the SRF388 and SRF617 Phase 1 and Phase 2 clinical trials as well as manufacturing expenses incurred for the SRF114 program. R&D expenses included $0.7 million in stock-based compensation expense for the third quarter ended September 30, 2022.
For the third quarter ended September 30, 2022, net loss was $23.2 million, or basic and diluted net loss per share of $0.39. Net loss was $19.9 million for the same period in 2021, or basic and diluted net loss per share of $0.44.
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). Surfaces 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 Oncologys managements 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 Oncologys 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 Oncologys 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 Oncologys 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 Oncologys product candidates, including SRF388 and SRF114, will not be successfully developed or commercialized; the risks related to Surface Oncologys dependence on third-parties in connection with its manufacturing, clinical trials and preclinical studies; the risk that Surface Oncology may not successfully find a third-party partner or collaborator for SRF617; changes in our operating plan and funding requirements; and the potential impact of COVID-19 on Surface Oncologys clinical and preclinical development timelines and results of operations. Additional risks and uncertainties that could affect Surface Oncologys future results are included in the section titled Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2021, available on the Securities and Exchange Commissions website at www.sec.gov and Surface Oncologys website at www.surfaceoncology.com. Additional information on potential risks will be made available in other filings that Surface Oncology makes from time to time with the Securities and Exchange Commission. In addition, any forward-looking statements contained in this press release are based on assumptions that Surface Oncology believes to be reasonable as of this date. Except as required by law, Surface Oncology assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.
Selected Financial Information
(In thousands, except share and per share amounts)
|Three months ended September 30,||Nine months ended September 30,|
|Statement of Operations Items||2022||2021||2022||2021|
Research and development
General and administrative
Total operating expenses
Loss from operations
Interest and other income (expense), net
Net loss per share basic and diluted
Weighted average common shares outstanding basic and diluted
|Selected Balance Sheet Items:||September 30,
Cash, cash equivalents and marketable securities
Accounts payable and accrued expenses
Total stockholders equity
# # #
SRF388 Clinical Data and Business Update Call November 2, 2022 Exhibit 99.2
This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this presentation other than statements of historical facts, including statements regarding future results of operations and financial position of Surface Oncology, Inc. (“we,” “us” or “our”) our business strategy and plans, the preclinical and clinical development of our product candidates and our objectives for future operations, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “estimate,” “expect,” “intend,” “may,” “will” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, clinical development, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward looking statements. These risks and uncertainties include the timing, progress, and results of preclinical studies and clinical trials for SRF617, SRF388 and SRF114, and our other product candidates, the timing and likelihood of regulatory approvals and those risks identified and discussed in the section titled “Risk Factors,” set forth in our Annual Report on Form 10-K and in our other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, achievements or events and circumstances reflected in the forward-looking statements will occur. We are under no duty to update any of these forward-looking statements after the date of this presentation to conform these statements to actual results or revised expectations, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements contained in this presentation. By attending or receiving this presentation you acknowledge that you will be solely responsible for your own assessment of the market and our market position and that you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of our business.
Review of SRF388 Non-Small Cell Lung Cancer Data (NSCLC) SRF114 Advancing Towards the Clinic
First-in-Class Antibody Targeting IL-27 High-affinity, fully human IgG1 antibody against IL-27 IL-27 is a highly immunosuppressive cytokine and serves as a “master switch” of checkpoint protein expression Translational and clinical evidence to support activity in liver and lung cancer Monotherapy activity in treatment-refractory NSCLC and ccRCC; Confirmed PR in HCC in combination with pembrolizumab Clinical trials in NSCLC and HCC as monotherapy and combination therapy in progress as part of clinical collaborations with Merck and Roche Next clinical update anticipated in 1H 2023 Overview of SRF388
Villarino, et al. Immunity. 2003; Saur, et al. J Immunol. 2008; Carbotti, et al. Oncotarget. 2015; Chihara, et al. Nature. 2018; DeLong, et al. Immunohorizons. 2019; Aghayev, et al. Cancer Discovery. 2022 Adaptive Immunity IFNγ IL-17 TNFα Decreased Cytokine Secretion IL-27 Macrophage or Dendritic Cell PD-L1 T cell LAG-3 TIM-3 TIGIT Increased Inhibitory Receptor Expression NK cell Constrains NK cell Immunosurveillance
PBMC Collection Gene Expression Analysis by RNA Sequencing Increased Expression of NK / CD8+ T Cell Activation Genes C1D1 pre-infusion C1D8 SRF388 Increased by SRF388 Decreased by SRF388 8 paired patient samples Granzyme A Perforin
Monotherapy Dose Escalation Patients with advanced solid tumors Established encouraging safety and tolerability profile up to highest dose tested (20 mg/kg) No DLTs observed to date Complementary cohorts encompassing different NSCLC disease subsets of interest: Monotherapy (up to 40 patients) contributes to understanding contribution of components across broader disease subsets and path to potential accelerated approval with strong data Pembro Combination (up to 40 patients) permits focused data in PD-L1 positive squamous and adenocarcinoma; well positioned to advance to Phase 3 with positive data RP2D, recommended phase 2 dose; ccRCC, clear cell renal cancer; HCC, hepatocellular cancer; NSCLC: non-small cell lung cancer; R/R: relapsed/refractory RP2D 10mg/kg 2-5L ccRCC SRF388 monotherapy single-arm Simon 2 Stage Phase 2 1L HCC SRF388/atezolizumab/bevacizumab 30 patient single-arm run-in 2-5L NSCLC SRF388 monotherapy single-arm Simon 2 Stage Phase 2 2-4L αPD-(L)1 R/R NSCLC SRF388 Pembro combo single-arm Simon 2 Stage Phase 2 Stopped to focus on NSCLC Stage 2 Opened October 2022 FPI anticipated October 2022 1L HCC SRF388/atezolizumab/bevacizumab ~105 patient randomized Phase 2
Preliminary data as of 24 Aug 2022, subject to change 2 confirmed PRs in PD-L1 negative or low, squamous NSCLC and 1 durable disease stabilization in adenocarcinoma, all previously treated with PD-(L)1 antibodies 10 evaluable patients dosed with SRF388; majority at RP2D of 10 mg/kg (n=6) and above (20 mg/kg, n=3) 22% ORR at RP2D and above and 100% (2/2) in squamous subset Two confirmed monotherapy PRs in αPD-(L)1-experienced patients with squamous cell histology (%) Change from Baseline 100 80 -80 -60 -40 -20 0 20 40 60 -100 Weeks 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 Patient Continuing Treated Past Progression DL5 (1.0 mg/kg) – Adeno DL7 (10.0 mg/kg) – Adeno DL7 (10.0 mg/kg) – Squam DL8 (20.0 mg/kg) – Adeno DL8 (20.0 mg/kg) – Spindle 100 80 -80 -60 -40 -20 0 20 40 60 (%) Change from Baseline 902-012/Adeno 902-008/Adeno 902-001/Adeno 903-006/Spindle 902-005/Adeno 903-011/Adeno 902-004/Adeno 903-008/Adeno 902-009/Squam 902-002/Squam Prior αPD-(L)1 Therapy DL5 (1.0 mg/kg) DL7 (10.0 mg/kg) DL8 (20.0 mg/kg) Best Percent Change from Baseline in Sum of Target Lesions (n=10) Target Lesion Change over Time (n=10)
Stained 120 archival samples from patients with NSCLC (70 SCC, 50 adenoCa), 21 small cell lung cancer (SCLC) samples, and 20 HNSCC samples IL-27+ macrophages present in 81% of squamous NSCLC cases, 75% of adenoCa, and 95% of HNSCC Three examples of IL-27 IHC in lung SCC highlighting positive macrophages in the TME Quantitation of IL-27+ macrophages 50 µm
Antibody Targeting CCR8 High-affinity, fully human afucosylated IgG1 antibody against CCR8 Specifically binds and preferentially depletes CCR8+ tumor Tregs Afucosylation enhances ADCC killing Highly specific for binding CCR8 exclusively IND open Overview of SRF114
Macrophage/DCs Depletion of Intra-tumoral Tregs With SRF114 Leads to In Vivo Monotherapy Activity CCR8+ Treg FcγR SRF114 SRF114 CCR8 CCR8 Macrophage/DCs NK cell FcγR Release of immuno-suppression Effector T cells Tumor cell Enhanced Anti-Tumor Response SRF114 Monotherapy Treatment Inhibits MC38 Tumor Growth Day 4 randomization, n=12 BIW, 5 doses Control = Isotype control Study Details NK cell
Compelling Pre-clinical SRF114 Data Support Best In Class Potential *Comparator antibody construction based on sequences obtained from patent literature Differentiation of SRF114 SRF114 selected based on exquisite specificity to human CCR8 Constructed four comparator antibodies* and all bound human proteins in addition to CCR8 SRF114 was the only antibody without any detectable non-CCR8 binding, giving SRF114 a potential safety advantage Clinical Plan Investigational New Drug (IND) application safe to proceed letter received First patient treated expected soon Initial safety/efficacy data in 2024
Anticipated Clinical Updates SRF388: Clinical data anticipated in H1 2023 SRF114: First patient expected soon; initial safety/efficacy clinical data in 2024
SRF388 Clinical Data and Business Update Call November 2, 2022