On May 9, 2022 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported financial results for the first quarter ended March 31, 2022, and noted key upcoming anticipated milestones (Press release, TScan Therapeutics, MAY 9, 2022, View Source [SID1234613943]).

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"This year will mark our transition to the clinic, as we prepare to enroll patients in our Phase 1 umbrella trial focused on the prevention of relapse in leukemia patients undergoing HCT. We plan to present data from the first dose cohort of the two treatment arms by the end of 2022," said David Southwell, President and Chief Executive Officer. "Additionally, we’re excited to share preclinical data on our solid tumor programs at the upcoming ASGCT (Free ASGCT Whitepaper) meeting. Following these presentations, we look forward to hosting our KOL event, which will describe how multiplexing across shared cancer targets and HLA types can help overcome resistance in solid tumors."

Recent Corporate Highlights

The Company will present two poster presentations and one oral presentation at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting being held both in Washington, D.C. and virtually May 16-19, 2022. Following the presentations, TScan will host a virtual KOL event featuring Kai Wucherpfennig, M.D., Ph.D., Chair, Cancer Immunology and Virology and Director, Center for Cancer Immunology Research at the Dana-Farber Cancer Institute, Professor of Neurology, Brigham and Women’s Hospital and Harvard Medical School, and Associate Member, Broad Institute of MIT and Harvard, on Thursday, May 19th at 4:30 p.m. ET to discuss the presentations, the potential advantages of multiplexing in TCR therapy, and the clinical plans for the Company’s solid tumor program. A link to the live event can be found here, and will remain archived on the Company’s website at ir.tscan.com.

The Company has grown its leadership team with the appointment of Leiden Dworak as Vice President, Finance. Mr. Dworak brings to TScan 15 years of experience in financial infrastructure implementation for clinical and manufacturing operations in the biotechnology and life sciences industries. Most recently, Mr. Dworak was Vice President, Head of Financial Planning and Analysis and Business Operations at AVROBIO, Inc. Prior to that, Mr. Dworak held positions of increasing responsibility in leading companies including Moderna, Inc., Merrimack Pharmaceuticals, Inc., SeraCare Life Sciences Inc. (now LGC Clinical Diagnostics, Inc.), and Boston Scientific Corporation. Mr. Dworak is a certified public accountant (CPA), inactive non-reporting license, and earned an MBA from Indiana University, Bloomington, Indiana.
Upcoming Anticipated Milestones

Leukemia Programs: TScan’s two lead leukemia TCR-T therapy candidates, TSC-100 and TSC-101, are designed to target HA-1 and HA-2, respectively, and treat patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation.

Initiate Phase 1 umbrella trial for TSC-100, with plans to enroll patients in the first half of 2022 in the TSC-100 and standard-of-care arms.
As previously disclosed, the FDA placed a clinical hold on the IND for TSC-101 in January 2022. The Company has since received written communication from the FDA asking for additional assessment of the potential for off-tumor reactivity in certain tissues. TScan is working with the agency to resolve its questions as quickly as possible. Pending acceptance from the FDA regarding the IND for TSC-101, the Company will then initiate the TSC-101 arm of this trial in the same patient population.
Anticipate presentation of initial clinical data from both treatment arms of the leukemia program at a medical meeting in the second half of 2022.
Solid Tumor Programs: TScan’s TSC-200 series of TCR-T therapy candidates include a combination of known targets, such as HPV16 for TSC-200, PRAME for TSC-203, and MAGE-A1 for TSC-204, as well as targets that are novel antigens for TCR-T therapy, such as those for TSC-201 and TSC-202. To address the resistance mechanisms of tumor heterogeneity and HLA loss, TScan is also developing TCRs for multiple HLAs across its targets and will now designate its TCR programs by their HLA restriction, such that the A*02:01 HLA restriction for the HPV TCR will be known as TSC-200-A02.

Present initial preclinical data on the TSC-200 series at the ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting.
Progress IND-enabling studies for the TSC-200 series and submit two IND applications during the second half of 2022. These are expected to include TSC-200-A02 for HPV and TSC-204-C7 for MAGE-A1.
In 2023, the Company plans to release initial clinical data for the TSC-200 series TCRs, as well as file further INDs for additional programs in this series.
Infectious Disease Program

Research is continuing into potential T cell focused COVID-19 vaccine constructs utilizing TScan’s novel T cell target discoveries. The Company is currently conducting preclinical studies for this program.
First Quarter 2022 Financial Results

As of March 31, 2022, TScan Therapeutics had cash and cash equivalents of $140.8 million excluding $5.0 million of restricted cash. Based on current operating plans, the Company believes that existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.

Revenue for the first quarter ended March 31, 2022, was $3.0 million, compared to $2.0 million for the first quarter ended March 31, 2021 (2021 Quarter). This increase is due to research activities related to TScan’s collaboration agreement with Novartis Institutes for Biomedical Research, on which work began in September 2020.

Research and development expenses for the first quarter ended March 31, 2022, were $14.7 million, compared to $7.3 million for the 2021 Quarter. The increase of $7.4 million was primarily a result of higher payroll expense, as well as higher manufacturing and pre-clinical expenses as the Company transitions to the clinic.

General and administrative expenses for the first quarter ended March 31, 2022, were $4.5 million, compared to $2.6 million for the 2021 Quarter. The increase of $1.9 million in general and administrative expenses was primarily a result of higher payroll expense and certain public company costs that were not present in the 2021 Quarter.

For the first quarter ended March 31, 2022, TScan Therapeutics reported a net loss of $16.2 million, compared to a net loss of $7.9 million for the 2021 Quarter.

As of March 31, 2022, the Company had issued and outstanding shares of 24,060,438 and 24,031,219, respectively.

On May 9, 2022 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical stage biotechnology company pioneering a new class of medicines that modulate gene expression through selectively targeting the chromatin regulatory system, reported a corporate update in conjunction with the Company’s 10-Q filing for the quarter ended March 31, 2022 (Press release, Foghorn Therapeutics, MAY 9, 2022, View Source [SID1234613942]). With an initial focus in oncology, Foghorn’s Gene Traffic Control Platform and resulting broad pipeline has the potential to transform the lives of people suffering from a wide spectrum of diseases.

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"With $424.7 million in cash on the balance sheet, Foghorn is well capitalized, to execute on its strategy of developing precision medicines targeting the chromatin regulatory system. This quarter, we continued to advance our robust pipeline that includes clinical and pre-clinical programs evaluating targeted protein degraders, enzymatic inhibitors and transcription factor disruptors for diverse cancers," said Foghorn CEO Adrian Gottschalk. "Specifically, we continue to enroll patients and dose escalate in our Phase 1 clinical studies of FHD-286 and FHD-609 and look forward to disclosing initial clinical data."

Key First Quarter 2022 Updates

FHD-286 Update. Foghorn expects to provide initial Phase 1 clinical data for FHD-286, an inhibitor of BRG1/BRM, in metastatic uveal melanoma (mUM), relapsed and/or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), in the second half of 2022.

FHD-609 Update. Enrollment is continuing in the Phase 1 clinical study of FHD-609, a potent and selective heterobifunctional protein degrader of BRD9, initially being developed for the treatment of synovial sarcoma with initial data expected in 2023.

2022 AACR (Free AACR Whitepaper) Annual Meeting. Presented preclinical data supporting the clinical development and mechanistic understanding of FHD-286’s anti-tumor activity in AML demonstrated by tumor inhibition in different cancer cell types, synergistic activity with combination medicines, including chemotherapy and other targeted therapies, and mutation agnostic responses in AML patient derived bone marrow samples.

BRM-selective Progress. Foghorn is advancing its BRM-selective programs in collaboration with Loxo Oncology at Lilly, with the BRM-selective inhibitor program in lead optimization and the protein degrader program in hit-to-lead stage. Foghorn is leading discovery and early research activities, and Lilly is leading development and commercialization activities with participation from Foghorn. U.S. economics will be shared equally, and Foghorn is eligible to receive royalties on ex-U.S. sales in the low double-digit to twenties range based on revenue levels.
Pipeline Advancement. Foghorn continued to advance its broad therapeutic pipeline of which the majority are wholly owned including protein degraders, enzymatic inhibitors and transcription factor disruptors targeting cancers impacted by breakdowns in the chromatin regulatory system.

Strong Balance Sheet and Cash Runway. As of March 31, 2022, the Company had $424.7 million in cash, cash equivalents and marketable securities.
About FHD-286

FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM, two highly similar proteins that are the ATPases, or the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies including both hematologic and solid tumors. To learn more about these studies please visit ClinicalTrials.gov. (Link here for metastatic uveal melanoma and here for AML and MDS).

About AML

Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.

About Uveal Melanoma

Uveal (intraocular) melanoma (UM) is a rare eye cancer that forms from cells that make melanin in the iris, ciliary body, and choroid. It is the most common eye cancer in adults. It is diagnosed in about 2,000 adults every year in the United States and occurs most often in lightly pigmented individuals with a median age of 55 years. However, it can occur in all races and at any age. UM metastasizes in approximately 50% of cases, leading to very poor prognosis.

About FHD-609

FHD-609 is a potent, selective, intravenously administered protein degrader of BRD9, a component of the ncBAF complex. Preclinical studies have demonstrated tumor growth inhibition in synovial sarcoma, a cancer genetically dependent on BRD9. To learn more about the first-in-human clinical trial of FHD-609 in synovial sarcoma, please visit ClinicalTrials.gov.

About Synovial Sarcoma

Synovial sarcoma is a rare, often aggressive soft tissue sarcoma that originates from different types of soft tissue, including muscle or ligaments. Synovial sarcoma can occur at any age but is most common among adolescents and young adults. It represents around 5-10% of all soft tissue sarcomas, with ~800 new cases each year in the United States. Surgery remains the most effective treatment for synovial sarcoma, and there are limited therapeutic treatment options.

On May 9, 2022 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported pipeline and business highlights and financial results for the first quarter ended March 31, 2022 (Press release, Beam Therapeutics, MAY 9, 2022, View Source [SID1234613941]). In addition, as part of a long-term effort to better understand sickle cell disease (SCD), a genetic disease in which individuals carry two copies of the sickle cell mutation, and sickle cell trait, in which individuals carry only one copy of the mutation, Beam will fund and collaborate with the National Alliance of Sickle Cell Centers (NASCC) to initiate the AUNT (Achieving Understanding of the Natural History of Sickle Trait) Study, a natural history study of sickle cell trait.

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"Base editing has the potential to offer life-changing medicines for a broad range of diseases, and we are committed to better understanding the pathophysiology of the diseases in our pipeline, and their impacts on the lives of patients and their families," said John Evans, chief executive officer of Beam. "We are excited to be collaborating with the Globin Research Network for Data and Discovery (GRNDad) on the AUNT natural history study in people with sickle cell trait. We are on track and expect to commence SCD patient enrollment in our Phase 1/2 BEACON-101 clinical trial to evaluate the safety and efficacy of BEAM-101 in patients with SCD, as well as make our planned IND submission for BEAM-102, which is also in development for the treatment of SCD. Our immunology and liver-directed pipelines are also progressing, with plans for additional regulatory submissions, research studies and program nominations throughout the year, and we continue to build upon our delivery capabilities, including our novel LNP technology platform, potentially allowing us to expand the future reach of our programs. We believe the parallel advancement of these diverse programs creates a broad foundation for our future growth and is evidence of our commitment to developing new and better treatments for multiple patient populations and to unlocking the full potential of precision genetic medicine."

Pipeline Highlights & Anticipated Milestones
Ex Vivo HSC Programs

Beam continues to advance its BEAM-101 program for the treatment of SCD and expects to enroll the first patient in its Phase 1/2 clinical trial evaluating the safety and efficacy of BEAM-101 for the treatment of SCD, referred to as the BEACON-101 trial, in the second half of 2022.
Beam’s second SCD-focused program, BEAM-102, continues to progress and the company plans to submit an investigational new drug (IND) application for BEAM-102 for the treatment of SCD in the second half of 2022.
Ex Vivo T Cell Programs

Beam’s BEAM-201 program for the treatment of relapsed/refractory T cell acute lymphoblastic leukemia/T cell lymphoblastic lymphoma is progressing with submission of an IND application anticipated in the second half of 2022.
Beam continues to make progress towards its planned nomination of a second CAR-T development candidate in 2022.
In Vivo LNP Liver-targeting Programs

Beam plans to present updated preclinical data from its BEAM-301 program at the American Society of Cell and Gene Therapy (ASGCT) (Free ASGCT Whitepaper) meeting, demonstrating high and durable editing efficiency in a mouse model of glycogen storage disease 1a (GSDIa) out to 35 weeks. Beam plans to initiate IND-enabling studies in 2022 for BEAM-301, a liver-targeting LNP formulation of base editing reagents designed to correct the R83C mutation, the most common disease-causing mutation of GSDIa.
Also at ASGCT (Free ASGCT Whitepaper), Beam will present new preclinical data from its base editing program targeting the treatment of alpha-1 antitrypsin deficiency, highlighting optimizations made to the editor and the guide RNA that have led to two-fold increases in observed editing potency in mice, leading to potentially clinically relevant increases in circulating alpha-1 antitrypsin at doses below 1 mg/kg.
Beam continues to anticipate the nomination of a second liver-targeted development candidate in 2022.
Initiation of AUNT Natural History Study
SCD is a severe, inherited blood disorder that alters the structure and function of oxygen-carrying hemoglobin in red blood cells and is caused by a single point mutation in the beta globin gene. Carriers of the disease, or individuals with sickle cell trait, have only one copy of the sickle mutation and produce variable amounts of the abnormal sickle hemoglobin (25-45% of total hemoglobin). Despite the high prevalence of sickle cell trait (estimated to affect 300 million individuals worldwide), research to understand its full biology and clinical features has been limited.

Beam is developing two programs for SCD, BEAM-101 and BEAM-102. BEAM-101 is designed to raise fetal hemoglobin while lowering abnormal sickle hemoglobin to <40% of total, which is similar to levels seen in individuals with sickle cell trait. BEAM-102 is designed to replace the sickle mutation with a normal human variant of hemoglobin, HbG-Makassar, potentially reducing even further the abnormal sickle hemoglobin in patient cells. A better understanding of sickle cell trait, along with an in-depth understanding of SCD, will help better establish the relationship between levels of the abnormal sickle hemoglobin and long-term clinical outcomes.

The AUNT Study will create a first of its kind multi-center, prospective, longitudinal cohort of individuals with sickle trait, targeting a large enrollment of approximately 1,000 participants. This research is designed to establish an understanding of the hematologic and clinical phenotype of people with sickle cell trait, including blood rheology, potential complications, and genetic modifiers, in an effort to better understand the hematologic phenotype that is associated with good health and lack of organ dysfunction, as well as provide increased counseling to people with sickle cell trait.

Business Updates

Manmohan Singh, Ph.D., senior vice president, pharmaceutical sciences & delivery technologies, was appointed to the company’s executive leadership team. Dr. Singh joined Beam in 2018, bringing more than 24 years of drug discovery and development experience from Takeda Pharmaceuticals, Novartis and Chiron Corporation.
Anne Marie Woodland joined Beam as senior vice president, regulatory affairs, bringing more than 20 years of experience to Beam, previously serving in regulatory focused roles at Replimune, UniQure and BioVex.
Upcoming ASGCT (Free ASGCT Whitepaper) Presentation Details
Title: Single, systemic administration of BEAM-301 mitigates fasting hypoglycemia and restores metabolic function in a transgenic mouse model of glycogen storage disease type Ia
Date & Time: Monday, May 16, 2022, from 4:15-4:30 p.m. ET

Title: Optimized base editing reagents yield more potent genetic correction in a mouse model of alpha-1 antitrypsin deficiency (poster M-123)
Date & Time: Monday May 16, 2022, from 5:30-6:30 p.m. ET

Title: Efficient LNP delivery of mRNA in vivo and in vitro to T and NK cells (poster Tu-107)
Date & Time: Tuesday May 17, 2022, from 5:30-6:30 p.m. ET

First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $1.2 billion as of March 31, 2022, as compared to $965.6 million as of December 31, 2021.
Research & Development (R&D) Expenses: R&D expenses were $65.4 million for the first quarter of 2022, compared to $190.1 million for the first quarter of 2021. R&D expenses for the first quarter of 2021 includes $155.0 million of expense related to in-process research and development acquired from Guide Therapeutics, Inc.
General & Administrative (G&A) Expenses: G&A expenses were $19.2 million for the first quarter of 2022, compared to $10.3 million for the first quarter of 2021.
Net Loss: Net loss was $69.2 million for the first quarter of 2022, or $1.01 per share, compared to $201.6 million for the first quarter of 2021, or $3.35 per share.

On May 9, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results for the first quarter ended March 31, 2022 (Press release, Mersana Therapeutics, MAY 9, 2022, View Source [SID1234613940]).

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"We believe that UpRi holds the potential to transform the treatment paradigm for patients with ovarian cancer. Our development strategy is designed to advance UpRi from platinum-resistant ovarian cancer with our potential UPLIFT data readout in 2023 into earlier lines of treatment with our UP-NEXT and UPGRADE trials," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "With a strengthened balance sheet and preparations to move XMT-1660 and XMT-2056 into the clinic in the near term, we look forward to delivering clinical data across all three of our platforms and building a leading ADC company."

Strategic Goals, Recent Developments and Anticipated Milestones

Build UpRi, a Dolaflexin ADC targeting NaPi2b, into a Foundational Medicine in Ovarian Cancer:
Presented Analysis Supporting UPLIFT Trial Dose: An analysis from nearly 100 patients in the expansion cohort of the Phase 1 Upifitamab Rilsodotin (UpRi) clinical trial based on a June 10, 2021 data cut was presented at the 2022 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer. This analysis supported the decision to select 36mg/m2 as the dose for UPLIFT, given the observed efficacy in both the evaluable and intent to treat populations, fewer adverse events (AEs) including Grade 3 or higher AEs, longer duration of treatment, and fewer discontinuations relative to the higher dose group.
Expecting to Complete Enrollment in UPLIFT Registration Trial in 3Q 2022: UPLIFT is enrolling up to 180 patients with platinum-resistant ovarian cancer, including approximately 100 patients with high NaPi2b expression. The trial’s primary endpoint will evaluate efficacy in the NaPi2b high population.
Advancing Toward Initiation of Patient Screening in UP-NEXT Trial in 2Q 2022: UP-NEXT is a Phase 3 clinical trial of UpRi as monotherapy maintenance following treatment with platinum doublets in recurrent platinum-sensitive ovarian cancer. This trial has the potential to serve as a post-approval confirmatory trial, supporting the expansion of UpRi into earlier lines of therapy.
Enrolling UPGRADE Combination Trial: UPGRADE, the company’s Phase 1/2 umbrella trial of UpRi in combination with other agents, is currently dose escalating UpRi in combination with carboplatin. Mersana expects to disclose interim data from this cohort in Q4 2022, with a primary focus on safety and tolerability. UPGRADE is intended to inform the further development of UpRi in combination with other therapies used in platinum-sensitive ovarian cancer.
Build Out Pipeline of Highly Impactful Cancer Medicines
Planning to Initiate Phase 1 Clinical Trial of XMT-1660 in Mid-2022: XMT-1660 is a B7-H4-directed Dolasynthen ADC with a precise and target-optimized drug-to-antibody ratio (DAR) of 6 and Mersana’s clinically validated DolaLock microtubule inhibitor payload with controlled bystander effect. In April, the company presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that a single dose of XMT-1660 had anti-tumor activity in xenograft models of both triple-negative breast cancer and estrogen receptor positive breast cancer. The data presented also demonstrated that higher B7-H4 expression was associated with greater anti-tumor activity of XMT-1660, consistent with its targeted effect. In its Phase 1 clinical trial, the company expects to investigate XMT-1660 in B7-H4-expressing tumors such as breast, endometrial and ovarian cancers.
Planning to Initiate Phase 1 Clinical Trial of XMT-2056 in Mid-2022: XMT-2056, the company’s first Immunosynthen STING agonist ADC, targets a novel epitope of HER2 and is designed to offer a differentiated and complementary therapeutic approach to existing and emerging solid tumor treatments. In April, the company presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating that XMT-2056 had robust anti-tumor activity as a monotherapy in both high and low HER-2 expressing models. The data showed XMT-2056’s complementary mechanism of action also resulted in increased efficacy across a number of models in combination with trastuzumab, pertuzumab, anti-PD-1 and trastuzumab deruxtecan. In its Phase 1 clinical trial, the company expects to investigate XMT-2056 in HER2-expressing tumors such as breast, gastric and non-small-cell lung cancers.
Maintaining Pipeline Prioritization Discipline: Based on the lower prevalence of the NaPi2b biomarker in non-small cell lung cancer, the increasingly competitive nature of this indication and the company’s commitment to remain financially disciplined, Mersana has decided to discontinue the development of XMT-1592. Additionally, the company has decided to defer certain investments in its preclinical pipeline, including two of its earlier-stage candidates, XMT-2068 and XMT-2175.
Build Mersana with Strategic Partners:
Announced New Collaboration with Janssen: In February, the company announced a research collaboration and license agreement with Janssen Biotech, Inc. to discover novel ADCs for up to three targets by leveraging Mersana’s Dolasynthen platform and ADC expertise and Janssen’s antibodies. As part of the agreement, Mersana received a $40.0 million upfront payment and has the potential to receive more than $1.0 billion in total milestone payments and mid-single-digit to low-double-digit percentage royalties on future net sales.
First Quarter 2022 Financial Results

Net cash used in operating activities in the first quarter of 2022 was $8.0 million. Cash and cash equivalents as of March 31, 2022, were $230.1 million, compared to $177.9 million in cash and cash equivalents as of December 31, 2021. This increase reflects the receipt of the $40.0 million upfront payment from Janssen and proceeds from the sale of Mersana common stock through its at-the-market (ATM) equity offering program, partially offset by operating spend. The company expects that its available funds will be sufficient to support its operating plan commitments well into the second half of 2023.
Research and development (R&D) expenses for the first quarter of 2022 were $35.8 million, compared to $27.4 million for the same period in 2021. Included in first quarter 2022 R&D expenses was $2.9 million in non-cash stock-based compensation. The year-over-year increase in R&D expenses was primarily related to greater headcount, preparations for the clinical advancement of XMT-1660 and XMT-2056, and increased UpRi manufacturing and clinical costs.
General and administrative (G&A) expenses for the first quarter of 2022 were $12.8 million, compared to $7.2 million during the same period in 2021. Included in first quarter 2022 G&A expenses was $2.6 million in non-cash stock-based compensation. The year-over-year increase in G&A expenses was primarily related to an increase in consulting and professional fees, and increased headcount.
Net loss for the first quarter of 2022 was $47.3 million, or $0.59 per share, compared to a net loss of $34.7 million, or $0.50 per share, for the same period in 2021.
Conference Call Reminder
Mersana will host a conference call today at 8:00 a.m. ET to discuss its financial results for the first quarter of 2022 and business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 4289737. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for at least 90 days.

On May 9, 2022 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 first quarter of 2022 as well as upcoming anticipated corporate milestones (Press release, Surface Oncology, MAY 9, 2022, View Source [SID1234613939]).

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"The first quarter of 2022 marked the beginning of a data-rich year for Surface, starting with the presentation of preclinical and translational SRF388 data at AACR (Free AACR Whitepaper) in April," said Rob Ross, M.D., chief executive officer. "We are actively developing two novel antibodies in Phase 2 studies, SRF388 and SRF617, and our runway now provides us with 12 months of cash beyond data readouts for up to six different indications and combination studies across the programs. We look forward to presenting our next update on SRF388, the only antibody targeting IL-27 in the clinic, at ASCO (Free ASCO Whitepaper), and we remain on track to share new clinical data for SRF617 in the second half of this year."

First Quarter and Subsequent Corporate Highlights

During the first quarter, Surface raised net proceeds of approximately $21 million through the company’s existing At-the-Market (ATM) facility with participation based on unsolicited interest received from EcoR1 and Octagon Capital Advisors.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, Surface presented SRF388 preclinical and translational data supporting the recommended Phase 2 monotherapy dose selection of 10 mg/kg administered intravenously every four weeks. This dose is being studied in dedicated expansion cohorts of treatment-refractory clear cell renal cell carcinoma (ccRCC), non-small-cell lung cancer (NSCLC), and hepatocellular carcinoma (HCC).

In March, Surface announced that the first patient had been dosed by GlaxoSmithKline (GSK) in a Phase 1 study evaluating GSK4381562 in patients with solid tumors. GSK4381562 is a fully human IgG1 antibody targeting PVRIG, an inhibitory protein on the TIGIT/DNAM/TACTILE axis that is expressed on natural killer cells (NK cells) and T cells. As a result, Surface is entitled to a $30 million milestone payment and is eligible to receive an additional $700 million in potential future milestone payments, and tiered royalties on global net sales.

In March, the company announced the appointment of Theresa Boni, J.D., as general counsel and senior vice president, legal. Ms. Boni brings more than 20 years of legal experience spanning the biopharmaceutical and medical device industries.
SRF388 Clinical Trial Progress and Updates

In April 2022, Surface announced the initiation of two Phase 2 clinical studies evaluating SRF388, a potential first-in-class antibody against IL-27. The initiations include the first patient dosed in a Phase 2 monotherapy clinical study in treatment-refractory NSCLC patients and the first patient dosed in the lead-in to a randomized Phase 2 clinical study in combination with atezolizumab and bevacizumab in patients with HCC who have not received prior systemic treatment (first-line).

With respect to the design of the SRF388 randomized Phase 2 study in first-line HCC, the company will expand the open-label lead-in from six patients, as originally planned, to approximately 30 patients. Management believes this expanded lead-in will provide more robust safety and efficacy data to inform the start of the randomized stage and could elucidate important biomarkers to support enriched patient selection. Data from the lead-in are anticipated in the first half of 2023.

New clinical data on SRF388 will be presented in an oral session at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. The session, entitled "First-in-human study of SRF388, a first-in-class IL-27 targeting antibody, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors," will be held Saturday, June 4, 2022, from 1:15 pm – 4:15 pm CDT.
Selected Anticipated Near-term Corporate Milestones

The company remains on track to provide a clinical data update on SRF617, a fully human antibody designed to inhibit CD39, in the second half of 2022.

Surface anticipates filing an Investigational New Drug application for SRF114, a fully human IgG1 anti-CCR8 antibody, in the second half of 2022.
Financial Results
As of March 31, 2022, cash, cash equivalents and marketable securities were $150.4 million, compared to $154.1 million on December 31, 2021.

General and administrative (G&A) expenses were $6.5 million for the first quarter ended March 31, 2022, compared to $5.6 million for the same period in 2021. This increase was primarily due to increases in personnel and facility-related costs and increased insurance premiums. G&A expenses included $1.3 million in stock-based compensation expense for the first quarter ended March 31, 2022.

Research and development (R&D) expenses were $16.6 million for the first quarter ended March 31, 2022, compared to $10.5 million for the same period in 2021. This increase was primarily driven by progress on our SRF617 and SRF388 Phase 1 clinical trials and advancement into Phase 2 trials. R&D expenses included $0.6 million in stock-based compensation expense for the first quarter ended March 31, 2022.

For the first quarter ended March 31, 2022, net income was $6.2 million, or basic net income per share of $0.13 and diluted net income per share of $0.13. Net loss was $15.6 million for the same period in 2021, or basic and diluted net loss per share of $0.37.

Based upon the current operating plan, Surface projects its cash runway extending into 2024.