On March 9, 2023 XOMA Corporation (NASDAQ: XOMA), the Biotech Royalty Aggregator, reported its full year 2022 financial results and provided an operational update on the Company’s actions to accelerate XOMA’s differentiated biotech royalty and milestone acquisition strategy (Press release, Xoma, MAR 9, 2023, View Source [SID1234628391]).

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"Since joining the Company in January, Brad Sitko and I have continually been impressed by the opportunities in front of XOMA. After having a significant number of royalty and milestone acquisition conversations since January, we are making decisions thoughtfully and rapidly about the opportunities on which we want to transact. We are assessing each potential opportunity with an eye to maximizing shareholder returns," stated Owen Hughes, Executive Chairman of XOMA.

"With cash receipts from Vabysmo (faricimab) and Day One’s public comments regarding filing a New Drug Application for tovorafenib in the first half of 2023, XOMA could be reporting incoming cash from two portfolio assets by the end of 2024. Our economic interests in both these assets were acquired within the past two years. In addition, we have learned from our partners’ public statements there also may be three assets entering Phase 3 development in 2023, which would further increase the value of XOMA’s portfolio. Those are just a few examples of the progression within the more than 70 royalty and milestone assets in our portfolio. With the potential incoming cash receipts from commercialized assets and anticipated milestone payments, we have the ability to accelerate our royalty acquisition strategy and continue to grow XOMA’s portfolio," said Brad Sitko, Chief Investment Officer of XOMA.

Fourth Quarter and Full Year 2022 Financial Results

Revenues for the fourth quarter and year ended December 31, 2022, were $1.5 million and $6.0 million, respectively. For the full year of 2022, XOMA’s reported revenues were related to milestone payments of $2.0 million from Rezolute, $0.8 million from Takeda, $0.8 million from Compugen, and $0.5 million from Sonnet. Revenues in the fourth quarter and year ended December 31, 2021, were $35.9 million and $38.2 million, respectively. For the full year of 2021, XOMA’s reported revenues included milestones of $35.0 million from Novartis, $0.5 million from Compugen, and $0.7 million from Janssen.

The Company’s research and development (R&D) expenses for the quarter and the full year of 2022 were $0.03 million and $0.2 million, respectively, compared to $0.04 million and $0.2 million in the corresponding periods of 2021.

General and administration (G&A) expenses were $7.6 million and $23.2 million for the fourth quarter and year-ended December 31, 2022, respectively. G&A expenses were $5.5 million and $20.5 million for the corresponding periods of 2021. The $2.7 million net increase in 2022, compared with 2021, was primarily due a $2.6 million increase in salaries and related expenses, including the $1.2 million Continuity Incentive accrued in connection with the retirement of Jim Neal, a $0.7 million increase in salaries and wages due to increased headcount and general salary increases, $0.4 million related to bonus payments to Mr. Neal pursuant to his amended employment agreement, and $0.1 million accrued in connection with the employee retention bonus. Additionally, an increase in consulting and legal costs of $2.3 million contributed to the overall increase in 2022. The totality of the increases in 2022 were partially offset by a $2.6 million reduction in stock-based compensation expense for stock options.

In the fourth quarter and full year of 2022, G&A expenses included $1.0 million and $3.6 million, respectively, in non-cash stock-based compensation expense, compared with $1.7 million and $6.2 million for the corresponding periods of 2021. XOMA’s net cash used in operations in the fourth quarter of 2022 was $3.9 million and $12.9 million for the full year of 2022, compared with net cash provided by operations in the fourth quarter of 2021 of $30.7 million and $22.7 million for the full year of 2021.

Net loss for the fourth quarter and year ended December 31, 2022, was $6.0 million and $17.1 million, respectively. Net income for the fourth quarter of 2021 was $29.8 million and $15.8 million for the full year of 2021.

On December 31, 2022, XOMA had cash and cash equivalents of $57.8 million and no debt on its balance sheet. On December 31, 2021, XOMA had cash and restricted cash of $95.4 million. On January 17, 2023, the Company paid cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) equal to $0.53906 per share and cash dividends on the 8.375%

Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO) equal to $0.52344 per depositary share. In February 2023, XOMA received a cash payment from Roche, representing the second commercial payment from XOMA’s 0.5% commercial interest in the sales of Vabysmo. The payment will be reflected in the Company’s condensed consolidated balance sheet as of March 31, 2023, as a reduction of short-term royalty and commercial payment receivables.

"The first year’s commercial performance of Vabysmo has demonstrated the significant impact that even a small percentage of sales from a single multi-billion-dollar product can have on XOMA’s financial outlook. Excluding any additional asset acquisitions, we believe incoming net cash of over $20 million from a combination of milestones that are expected this year together with anticipated royalties should cover our annual base operating and dividend expenses in 2023. Given the nature of our milestone and royalty agreements, we expect cash flows will be uneven on a quarterly basis over the next few years. This reflects the imprecise timing of when milestones occur and assets are commercialized. Looking at 2024, the milestones and royalties we anticipate should continue to contribute significantly towards covering our base operating expenses and dividend obligations," stated Tom Burns, Chief Financial Officer at XOMA.

On March 9, 2023 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the fourth quarter and full-year ended December 31, 2022 and provided business highlights (Press release, Akebia, MAR 9, 2023, View Source [SID1234628390]).

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"We ended our year delivering on our strategic focus, which included a commitment to maximize Auryxia revenue, support vadadustat globally and thoughtfully invest in our pipeline," said John P. Butler, Chief Executive Officer of Akebia. "We believe the work our team executed through the fourth quarter and more broadly in 2022 has put us in a strong position as we prepare for several meaningful upcoming milestones. Building on our positive CHMP opinion for vadadustat in Europe, we anticipate potential Marketing Authorization of Vafseo by the European Commission in May 2023, and we are active in our process to select a partner in Europe to deliver Vafseo to patients with chronic kidney disease (CKD) on dialysis, if approved."

Last month, Akebia announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the European Commission (EC) to approve Vafseo (vadadustat), for the treatment of symptomatic anaemia associated with CKD in adults on chronic maintenance dialysis. If approved, an EC Marketing Authorization of Vafseo would be applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. Akebia is seeking a partner to commercialize vadadustat in Europe.

Additionally, Akebia had an important year with several key milestones in 2022 and into early 2023

Achieved Auryxia revenue of $177.1 million representing 24.5% growth versus 2021

Implemented multiple initiatives to reduce costs and create a clear path to positive cash flows from operations supported by Auryxia revenues

Restructured and simplified the Auryxia supply chain, saving significant anticipated cash over a five-year period

Signed a European license agreement with Averoa SAS for the development and commercialization of Auryxia in Europe

Regained the rights from Otsuka Pharmaceutical Co. Ltd. for vadadustat in the U.S., Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories

Assumed responsibility for vadadustat regulatory filings in EMA and ACCESS Consortium countries: U.K., Switzerland and Australia

Submitted a Formal Dispute Resolution Request (FDRR) to the U.S. Food and Drug Administration (FDA), disputing the Complete Response Letter (CRL) for vadadustat received in March 2022; and

Released data from an investigator-sponsored clinical study with the University of Texas Health Sciences Center, Houston (UT Health), evaluating vadadustat for the prevention and treatment of COVID-19 related acute respiratory distress syndrome (ARDS).

Pipeline Progress Expected in 2023

Obtain potential Marketing Authorization for Vafseo expected in Europe in May 2023

Receive regulatory decision for vadadustat for U.K., Switzerland and Australia

Receive decision on appeal process related to CRL for vadadustat

Present data from the IMPACT investigator-sponsored study evaluating the effect of Auryxia as a phosphate binder on utilization of IV iron and erythropoiesis-stimulating agents on dialysis patients

Present data from the FOCUS study on three times weekly dosing for vadadustat in dialysis patients

Initiate UT Health study of vadadustat for the prevention and treatment of ARDS in a broader population beyond patients with COVID-19

Assess potential regulatory path for vadadustat in other acute treatment indications; and

Advance preclinical development of multiple novel hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor compounds for potential indications of serious unmet need.

"Auryxia revenue continues to fund our business, and we entered 2023 with a robust operating plan, including funding for several compelling pipeline opportunities," said David A. Spellman, Chief Financial Officer of Akebia. "Regarding revenue, we reported nearly 25% net product revenue growth for Auryxia over 2021, which exceeded guidance. The fourth quarter of 2022 included an inventory build of approximately $3M year over year. We have set 2023 net product revenue guidance at $175-180 million as we remain cautious about a phosphate binder market recovery; the market continues to contract modestly due to COVID-19 and dialysis staffing issues. We will continue to be mindful of non-essential spend and work to reduce costs overall."

Financial Results

Revenues: Total revenue was $55.2 million in the fourth quarter of 2022 compared to $59.6 million for the fourth quarter of 2021, and $292.6 million for the full-year 2022 compared to $213.6 million for full-year 2021

Net product revenue was $49.7 million in the fourth quarter of 2022 compared to $42.1 million in the fourth quarter of 2021, an 18.1% increase. Net product revenue was $177.1 million for the full-year 2022 compared to $142.2 million for the full-year 2021, an increase of approximately 24.5%. The increase compared to the fourth quarter and full-year of 2021 is primarily due to pricing and improved payer mix, and a 2022 year-end inventory build by a customer that exceeded 2021. Total units sold decreased year over year

License, collaboration, and other revenue was $5.5 million for the fourth quarter of 2022 compared to $17.5 million for the fourth quarter of 2021, and $115.5 million for the full-year 2022 compared with $71.4 million for the full-year 2021. The increase for the full-year 2022 reflects a nonrefundable and non-creditable payment of $55.0 million that Otsuka paid to Akebia in July 2022 under the terms of a termination and settlement agreement between the companies. In addition, Akebia recognized $15.5 million related to previously deferred revenue as of the date of termination and $9.6 million of non-cash consideration related to Otsuka’s obligations to complete certain agreed upon clinical activities. Additionally, Akebia recognized $19.1 million in collaboration revenue in 2022 from the cost sharing arrangement with Otsuka prior to the termination, compared to $53.0 million for the full-year 2021

Auryxia revenue guidance for 2023 of $175—$180 million assumes, among other things, an increase in realized net price per pill, partially offset by a reduction in total units sold and inventories returning to normal levels

COGS: Cost of goods sold was a benefit of $3.1 million for the fourth quarter of 2022 compared to a cost of $50.4 million for the fourth quarter of 2021. Cost of goods sold was $84.8 million for the full-year 2022, compared with $153.4 million for the full-year 2021. The decrease in both periods compared to the same periods in 2021 was primarily due to a non-cash reduction of our excess purchase commitment liability driven by the reduction in purchase commitments with the restructuring of our supply chain. The decrease was partially offset by contract termination fees and inventory reserves associated with Auryxia drug substance that will not be forward processed

R&D Expenses: Research and development expenses were $31.9 million for the fourth quarter of 2022 compared to $29.6 million for the fourth quarter of 2021, and $129.1 million for the full-year 2022 compared to $147.9 million for the full-year 2021. The increase for the fourth quarter of 2022 compared to the fourth quarter of 2021 was largely due to a one-time credit of $8.6 million representing a reimbursement from Vifor Pharma following the sale of the Priority Review Voucher that occurred in 2021. The decrease for the full-year 2022 compared to the full-year 2021 was primarily due to decreased headcount related costs as a result of the April 2022 reduction in force, decreased consulting costs, and decreased outsourced contract services

SG&A Expenses: Selling, general and administrative expenses were $30.6 million for the fourth quarter of 2022 compared to $44.8 million for the fourth quarter of 2021, and $138.7 million for the full-year 2022 compared to $174.2 million for the full-year 2021. The decrease in both periods compared to the same periods in 2021 was primarily due to decreased headcount related costs as a result of both the April 2022 and November 2022 reductions in force, decreased one-time legal costs, and lower marketing expenses following receipt of the CRL for vadadustat

Net Loss: Net loss was $7.6 million for the fourth quarter of 2022 compared to $70.7 million for the fourth quarter of 2021, and $92.6 million for the full-year 2022 compared to $282.8 million for the full-year 2021. The decrease in net loss for the full-year 2022 compared to the prior year was due primarily to higher revenues, lower cost of goods sold and lower operating expenses, partially offset by restructuring expenses in 2022

Cash Position: Cash and cash equivalents as of December 31, 2022 were $90.5 million. Akebia believes that its cash resources will be sufficient to fund its current operating plan for at least the next twelve months. Akebia’s operating plan assumed certain contractual changes and cost avoidance measures would be executed over the course of 2022, which has now occurred. Akebia’s objective is to fund its current operating plan with existing cash resources and cash from operations for at least the next twelve months. Future decisions by the FDA or other regulatory agencies related to the potential regulatory approval of vadadustat, or Akebia’s ability to generate additional value from vadadustat through partnerships or other transactions, may potentially further extend our cash runway, but are not currently reflected in the operating plan. Akebia also plans to continue to work on initiatives to extend its revenues from Auryxia beyond the anticipated loss of exclusivity in March 2025.

Conference Call

Akebia will host a conference call on Thursday, March 9 at 8:30 a.m. ET to discuss its financial results and recent business highlights. To access the call, please register by clicking on this Registration Link, and then you will be provided with dial in details. To avoid delays, we encourage dialing into the conference call fifteen minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the Investors section of Akebia’s website at: View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source approximately two hours after the event.

On March 9, 2023 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies, based on its novel DPX platform, to treat solid and hematologic cancers, reported that it will hold a conference call and webcast on Thursday, March 16, 2023, at 8:00 a.m. ET to discuss the company’s 2022 fourth quarter and fiscal year-end financial and operational results (Press release, IMV, MAR 9, 2023, View Source [SID1234628388]).

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Financial analysts are invited to join the conference call by registering at this link prior the call to receive their individual dial-in information.

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.

On March 9, 2023 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development, and commercialization of transformative targeted therapies, reported business highlights and reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Theseus Pharmaceuticals, MAR 9, 2023, View Source [SID1234628386]).

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"2022 was a year of significant progress for Theseus across our growing pipeline. We initiated our first-in-human study for our lead candidate, THE-630, in advanced GIST; nominated THE-349 as the development candidate for our fourth-generation EGFR inhibitor program for patients with NSCLC; and made substantial progress across our discovery pipeline, culminating with the recent introduction of our third program, targeting BCR-ABL in patients with CML and Ph+ ALL," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "With a strong cash runway, we are poised to continue executing in 2023 as we anticipate two clinical readouts from the ongoing dose-escalation study of THE-630, the IND filing for THE-349, and continued progress across our preclinical and discovery programs."

Recent Pipeline Highlights and Upcoming Expected Milestones:

THE-630 is a pan-variant tyrosine kinase inhibitor (TKI) of the receptor tyrosine kinase KIT, designed for patients with gastrointestinal stromal tumors (GIST) that have developed resistance to earlier lines of therapy.

● Enrollment is ongoing for the phase 1 portion of the phase 1/2 dose-escalation and expansion clinical trial evaluating THE-630 in patients with advanced GIST, with all seven phase 1 sites open in the U.S. and accruing. Theseus is treating patients in cohort 6 of dose escalation as of March 9, 2022.
● Theseus plans to present preliminary safety, pharmacokinetic (PK), and initial clinical activity data through cohort 6, as well as an analysis of circulating tumor DNA (ctDNA) data up to cohort 5, at a scientific conference in the second quarter of 2023.
● Theseus plans to present follow-up data at a scientific conference in the fourth quarter of 2023, which is expected to include data from additional dose escalation cohorts, including cohorts 7 and 8, where Theseus expects to have reached the target systemic exposure for pan-variant KIT activity of 100 nanomolar (nM) average concentration (Cav).

THE-349 is a fourth-generation (4G) epidermal growth factor receptor (EGFR) TKI development candidate with activity against single-, double-, and triple-mutant EGFR variants, including T790M and C797X, found in EGFR-mutant non-small cell lung cancer (NSCLC) that has developed resistance to first- or later-line osimertinib.

● In the third quarter of 2022, Theseus announced the nomination of THE-349 as the development candidate for its second development program, targeting EGFR-mutant NSCLC.
● Preclinical data demonstrate THE-349 can potently inhibit all major classes of EGFR activating and resistance mutations observed in a post-first- or later-line osimertinib setting, possesses kinome and wild-type EGFR selectivity, and has central nervous system (CNS) activity.
● Theseus expects to submit an Investigational New Drug Application (IND) for THE-349 to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2023 and to initiate the clinical program as soon as possible thereafter, subject to clearance of the IND by the FDA.

BCR-ABL Program: Theseus is aiming to develop a potent and selective, next-generation, pan-variant BCR-ABL TKI candidate that optimizes the balance of safety and efficacy for patients with relapsed/refractory chronic myelogenous leukemia (CML) and patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

● In January 2023, Theseus announced the prioritization of a new TKI program targeting BCR-ABL in patients with relapsed/refractory CML and newly diagnosed Ph+ ALL.
● Preclinically, Theseus lead molecules have shown a high degree of potency against BCR-ABL and clinically relevant resistance mutations, such as the T315I gatekeeper mutation, and substantial kinome selectivity.
● Theseus expects to nominate a development candidate for this program by early 2024, with the goal of pursuing clinical development in patients with CML who have been previously treated with a second-generation (2G) TKI or have the T315I mutation, and in newly diagnosed patients with Ph+ ALL.

Business Highlights:

● Theseus recently appointed three leaders to key positions, including Ron Knickerbocker, Ph.D., as Senior Vice President, Biometrics and Clinical Development Strategy; Shouryadeep "Deep" Srivastava, M.D., Ph.D., as Vice President, Clinical Development; and Ben Enerson as Vice President, Legal Affairs.

Fourth Quarter and Full Year Financial Results:

Cash Position: As of December 31, 2022, Theseus had cash, cash equivalents, and marketable securities of $211.8 million, as compared to $244.7 million as of December 31, 2021. Theseus expects its current cash, cash equivalents, and marketable securities to fund operations and capital expenditures into the third quarter of 2025 based on its current operating plan.

R&D Expenses: Research and development expenses were $10.4 million for the fourth quarter of 2022 and $35.7 million for the year ended December 31, 2022, as compared to $5.0 million for the fourth quarter of 2021 and $18.3 million for the year ended December 31, 2021. This year-over-year increase was primarily due to $9.6 million of increased employee-related costs driven by an increase in headcount, and $3.8 million of increased expenses for clinical and preclinical studies as Theseus continued to advance THE-630 and THE-349 in clinical and preclinical studies, respectively, as well as $2.8 million of increased expense for its discovery programs.

G&A Expenses: General and administrative expenses were $5.1 million for the fourth quarter of 2022 and $18.4 million for the year ended December 31, 2022, as compared to $3.6 million for the fourth quarter of 2021 and $9.0 million for the year ended December 31, 2021. This year-over-year increase was primarily due to $5.6 million of increased employee-related costs driven by an increase in headcount, as well as $3.8 million of increased professional fees and other general expenses driven by costs associated with operating as a growing public company.

Net Loss: Net loss was $13.7 million for the fourth quarter of 2022, as compared to a net loss of $8.7 million for the fourth quarter of 2021. Net loss was $50.6 million for the full year 2022, or a net loss per share of $1.31, as compared to a net loss of $27.3 million for the full year 2021, or a net loss per share of $2.84.

On March 9, 2023 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the fourth quarter and full year 2022, as well as anticipated near-term corporate milestones (Press release, Surface Oncology, MAR 9, 2023, View Source [SID1234628385]).

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"Our teams have done an outstanding job advancing SRF388 and SRF114, and we are pleased with the progress of both clinical programs," said Rob Ross, M.D., chief executive officer of Surface. "We believe SRF388 is the first and only anti-IL-27 antibody in clinical development and, based on the encouraging preclinical and clinical data we have generated to date, it holds the potential to become a first-in-class treatment for patients suffering from multiple life-threatening solid tumors. We look forward to sharing additional SRF388 data from our ongoing trials in the first half of 2023."

Dr. Ross added, "As for SRF114, CCR8 is a very compelling immuno-oncology target. While several leading pharmaceutical and biotech companies have initiated programs in this space, we believe SRF114 is differentiated from many of them based on its high specificity to human CCR8, leading to a potential best-in-class antibody. We expect to have initial safety and efficacy data in 2024."

Fourth Quarter and Subsequent Corporate Highlights

In the fourth quarter of 2022, Surface announced encouraging new SRF388 monotherapy data in non-small cell lung cancer (NSCLC) with two confirmed partial responses, as well as a third patient with adenocarcinoma who 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 opened the second stage of the Simon’s 2-stage monotherapy trial which is expected to enroll 40 patients with NSCLC in total. In addition, Surface 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-(L)1 agents. The study is anticipated to enroll up to 40 patients with NSCLC.
In January 2023, Surface announced the first patient had been dosed in a Phase 1/2 study evaluating SRF114 as a monotherapy in patients with advanced solid tumors. SRF114 is a potential best-in-class, fully human, afucosylated anti-CCR8 antibody that has demonstrated highly specific binding properties exclusively to human CCR8 in preclinical studies.
Following a strategic portfolio review, Surface announced the decision to pause the internal clinical development of SRF617, a novel antibody targeting CD39, and pursue potential business development opportunities for the program. As a result of the reprioritization, the company conducted a corresponding workforce reduction and implemented cost reduction efforts, which extended cash runway.
Surface presented non-clinical SRF388 and SRF114 data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 Annual Meeting in Boston. A poster presentation detailed the immune-suppressive communication, co-localization, and upregulation between IL-27 and PD-L1 expression within the tumor microenvironment, supporting clinical studies evaluating SRF388. Additionally, Surface presented SRF114 preclinical data that demonstrated the antibody’s ability to selectively deplete tumor Treg cells, resulting in dose-dependent activation of immune cells, and a potential mechanism to inhibit tumor growth independent of checkpoint inhibition.
In October 2022, Cell Reports published findings from a preclinical collaboration study between Surface and VIB detailing the structural basis of IL-27 receptor activation and signaling by the IL-27 cytokine. The study further elucidated SRF388 binding properties to IL-27 to prevent interaction with the IL-27 receptor, inhibiting the cytokine’s signaling activity and providing structural evidence for SRF388’s potent antagonistic properties.
Selected Anticipated Near-term Corporate Milestones

In the first half of 2023, Surface expects to present updated clinical data from the ongoing Phase 2 trials investigating SRF388 in liver and lung cancer.
Initial safety and efficacy data from the ongoing SRF114 Phase 1/2 clinical study are anticipated in 2024.
Financial Results

As of December 31, 2022, cash, cash equivalents and marketable securities were $124.8 million, compared to $154.1 million on December 31, 2021.

Research and development (R&D) expenses were $15.3 million for the fourth quarter ended December 31, 2022, compared to $16.3 million for the same period in 2021. R&D expenses were $67.0 million for the full year ended December 31, 2022, compared to $53.6 million for the same period in 2021. This increase was primarily driven by continued enrollment and advancement into the Phase 2 of our ongoing SRF388 clinical trials, increased manufacturing costs, increased costs associated with advancing our SRF114 program into the clinic, and increased costs associated with our corporate restructuring in November 2022. R&D expenses included $2.6 million in stock-based compensation expenses for the full year ended December 31, 2022.

General and administrative (G&A) expenses were $5.9 million for the fourth quarter ended December 31, 2022, compared to $7.2 million for the same period in 2021. G&A expenses were $24.9 million for the full year ended December 31, 2022, compared to $25.1 million for the same period in 2021. The decrease was primarily due to a decrease in employee related expenses as well as legal and professional fees. This was partially offset by increases in severance relating to our corporate restructuring in November 2022. G&A expenses included $4.6 million in stock-based compensation expense for the full year ended December 31, 2022.

For the fourth quarter ended December 31, 2022, net loss was $21.3 million, or basic and diluted net loss per share of $(0.35). Net loss was $24.1 million for the same period in 2021, or basic and diluted net loss per share of $(0.52). For the full year ended December 31, 2022, net loss was $63.6 million, or basic and diluted net loss per share of $(1.14). Net loss was $78.5 million for the same period in 2021, or basic and diluted net loss per share of $(1.77).

Based upon its current operating plan and recent cost savings initiatives, Surface now projects it has cash runway into the third quarter of 2024.

About SRF388

SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including liver and lung cancer, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immunosuppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies including anti-PD-1 therapy, as well as potent anti-tumor effects as a monotherapy. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping to identify patients most likely to respond to SRF388. In November 2020, Surface announced that SRF388 was granted Orphan Drug designation and Fast Track designation for the treatment of refractory hepatocellular carcinoma from the FDA.

About SRF114

SRF114 is a fully human, afucosylated anti-CCR8 antibody designed to preferentially deplete CCR8+ Treg cells within the tumor microenvironment. In preclinical studies, Surface Oncology has shown that SRF114 induces antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) pathways to deplete intratumoral Treg cells. In addition, SRF114 reduced tumor growth in murine models. These findings support the advancement of SRF114 as a therapeutic candidate that holds the potential to drive anti-tumor immunity in patients.