On August 3, 2023 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, reported financial results for the second quarter ended June 30, 2023 and provided a review of recent business and clinical highlights (Press release, Xencor, AUG 3, 2023, View Source [SID1234633780]).

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"In the past quarter we continued to advance a clinical portfolio of XmAb drug candidates, enrolling patients across multiple Phase 1 and Phase 2 studies in oncology and autoimmune diseases. By year end we anticipate opening a Phase 2 study to evaluate vudalimab as a front-line treatment in metastatic non-small cell lung cancer, a large patient population with high unmet need," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Our ongoing studies with early-stage, novel XmAb bispecific antibodies continue to generate exceptionally strong interest among investigators, in particular our ENPP3-targeted CD3 T-cell engager in renal cell carcinoma, XmAb819, and our B7H3-targeted tumor-selective CD28 co-stimulatory T-cell engager, XmAb808. Both candidates use novel antibody formats to drive tumor-specific activity that has the potential to address current gaps in treatment approaches.

"We also continue to expand the portfolio of XmAb programs. We recently initiated a Phase 1 study of our potency-tuned IL12-Fc, XmAb662, to be developed in oncology, and we expect to submit an IND application later this year for XmAb541, a 2+1 format CLDN6 x CD3 bispecific antibody that we are developing for patients with ovarian cancer and other tumor types. Additionally, we anticipate submitting an IND for our second internal CD28 program in 2024."

Program Updates

Vudalimab (PD-1 x CTLA-4): Xencor plans to evaluate vudalimab, a T-cell selective checkpoint inhibitor, as a first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer. Part 1 of a Phase 2 study would randomize a limited number of patients at one of two doses of vudalimab, in combination with chemotherapy. The study’s second part would randomize patients to either vudalimab plus chemotherapy or pembrolizumab plus chemotherapy. The primary outcome measure of Part 2 would be a comparison of progression-free survival. Xencor anticipates initiating the study by the end of 2023.
Xencor is conducting an ongoing Phase 2 study evaluating vudalimab as a monotherapy in patients with high-risk metastatic castration-resistant prostate cancer (mCRPC) or advanced gynecologic malignancies and an ongoing Phase 2 study evaluating vudalimab in combination with chemotherapy or a PARP inhibitor in patients with mCRPC. Clinical data from these studies are anticipated to be presented at a medical conference in early 2024.

XmAb564 (IL2-Fc): Results from a Phase 1a clinical study in healthy volunteers were presented at the European Congress of Rheumatology (EULAR) in May 2023. Data continue to indicate a single dose of subcutaneously administered XmAb564 was well tolerated and generated durable, dose-dependent and selective expansion of regulatory T cells. Xencor is conducting a randomized, double-blind, placebo-controlled Phase 1b study to evaluate the safety and tolerability of multiple ascending doses of XmAb564 in patients with atopic dermatitis or psoriasis.
XmAb662 (IL12-Fc): XmAb662 is a potency-reduced interleukin-12 Fc (IL12-Fc) fusion protein engineered to increase anti-tumor activity and immunogenicity in the tumor microenvironment by promoting high levels of interferon gamma secretion from T cells and NK cells. In July 2023, Xencor initiated a Phase 1 study in patients with advanced solid tumors.
Partnership Updates

Alexion Pharmaceuticals, Inc.: In May 2023, Ultomiris (ravulizumab-cwvz), which incorporates Xencor’s Xtend Fc domain, was approved in the EU and Japan for the treatment of certain adult patients with neuromyelitis optica spectrum disorder (NMOSD). In the second quarter of 2023, Xencor earned $11.2 million of royalty revenue from Alexion on net sales of Ultomiris.
Amgen Inc.: Interim results from a Phase 1 study of xaluritamig (AMG 509), a STEAP1 x CD3 XmAb 2+1 bispecific antibody, in patients with mCRPC were accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on October 20, 2023.
Zenas BioPharma Ltd.: In the second quarter of 2023, Xencor earned a $10 million development milestone related to Zenas’ Phase 3 study evaluating obexelimab in patients with immunoglobulin G4-related disease (IgG4-RD). A manuscript with results from the Phase 2 study, which was sponsored and conducted by Xencor, was first published online in The Lancet Rheumatology in August 2023.
Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc.

Financial Results for the Second Quarter and Six Months Ended June 30, 2023

Cash, cash equivalents, receivables and marketable debt securities totaled $531.4 million as of June 30, 2023, compared to $613.5 million as of December 31, 2022.

Total revenue for the second quarter ended June 30, 2023 was $45.5 million, compared to $30.2 million for the same period in 2022. Revenues earned in the second quarter of 2023 were primarily from research revenue from our second Janssen Biotech collaboration, royalty revenue from Alexion and milestone revenue from Zenas, compared to the same period in 2022, which were primarily royalties from Alexion and Vir Biotechnology. Revenues for the six months ended June 30, 2023 were $64.5 million, compared to $115.7 million for the same period in 2022. Revenue for the six-month period in 2023 were primarily from research revenue from our second Janssen collaboration, royalty revenue from Alexion and milestone revenue from Janssen and Zenas, compared to the same period in 2022, which were earned primarily from milestone revenue from Astellas and royalty revenue from Alexion, MorphoSys and Vir.

Research and development (R&D) expenses for the second quarter ended June 30, 2023 were $60.1 million, compared to $47.1 million for the same period in 2022. Increased R&D spending for the second quarter of 2023 compared to 2022 is primarily due to increased spending on development programs including vudalimab, plamotamab, XmAb819 and XmAb541 and other research and early-stage programs. R&D expenses for the six months ended June 30, 2023 were $124.4 million, compared to $94.8 million for the same period in 2022. Increased R&D spending for the first six months of 2023 compared to 2022 is primarily due to an increase in spending on development programs including vudalimab, XmAb541 and XmAb564 and other research and early-stage programs.

General and administrative (G&A) expenses for the second quarter ended June 30, 2023 were $11.5 million, compared to $11.1 million for the same period in 2022. G&A expenses for the six months ended June 30, 2023 were $25.4 million, compared to $22.4 million for the same period in 2022. Increased G&A spending for the second quarter and first six months of 2023 compared to the same periods in 2022 reflects increased spending on professional services and additional facility costs.

Other income (expense) for the second quarter ended June 30, 2023 was $4.0 million, compared to $(6.0) million for the same period in 2022. Other income (expense) for the six months ended June 30, 2023 was $2.6 million, compared to $(8.8) million for the same period in 2022. The increase in other income for the three and six months ended June 30, 2023 over other expense for the same periods in 2022 is due to additional interest income earned and lower unrealized loss recorded from equity investments.

Non-cash, stock-based compensation expense for the six months ended June 30, 2023 was $26.2 million, compared to $23.4 million for the same period in 2022.

Net loss for the second quarter ended June 30, 2023 was $22.0 million, or $(0.37) on a fully diluted per share basis, compared to net loss of $34.0 million, or $(0.57) on a fully diluted per share basis, for the same period in 2022. Decreased net loss in the second quarter of 2023 compared to 2022 is primarily due to additional income and interest earned. For the six months ended June 30, 2023, net loss was $82.7 million, or $(1.38) on a fully diluted per share basis, compared to net loss of $10.4 million, or $(0.17) on a fully diluted per share basis, for the same period in 2022. Increased net loss in the first six months of 2023 compared to 2022 is primarily due to decreased royalties from Vir and increased R&D expenses.

The total shares outstanding were 60,600,060 as of June 30, 2023, compared to 59,684,420 as of June 30, 2022.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations through the end of 2025. The Company expects to end 2023 with between $425 million and $475 million in cash, cash equivalents, receivables and marketable debt securities.

Conference Call and Webcast

Xencor will host a conference call and webcast today at 4:30 p.m. ET (1:30 p.m. PT) to discuss the second quarter 2023 financial results and provide a corporate update.

The live webcast may be accessed through "Events & Presentations" in the Investors section of the Company’s website, located at investors.xencor.com. Telephone participants may register to receive a dial-in number and unique passcode that can be used to access the call. A recording will be available for at least 30 days.

On August 3, 2023 X4 Pharmaceuticals (Nasdaq: XFOR), a leader in the discovery and development of novel small-molecule therapeutics to benefit people with rare diseases of the immune system, reported the closing of a $115 million loan facility with Hercules Capital, Inc. (NYSE: HTGC) ("Hercules") (Press release, X4 Pharmaceuticals, AUG 3, 2023, View Source [SID1234633779]). The company also announced that it drew down $22.5 million upon the transaction’s closing.

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"This expanded loan facility creates significant financial flexibility for X4 as we continue preparations for the potential commercial launch of mavorixafor in individuals with WHIM syndrome and continue to advance mavorixafor for certain chronic neutropenic disorders," said Adam Mostafa, Chief Financial Officer of X4 Pharmaceuticals. "The initial draw down not only strengthens our balance sheet on a non-dilutive basis and extends our projected cash runway into 2025, but the overall transaction also creates expanded, future optionality beyond the equity capital markets as we potentially commence product sales and monetize a priority review voucher next year."

"Hercules is very pleased to continue to support X4 and expand our partnership ahead of the potential approval and commercial launch of mavorixafor in WHIM syndrome and expected upcoming development progress in potentially treating certain chronic neutropenic disorders," said Bryan Jadot, Senior Managing Director and Head of Life Sciences at Hercules Capital. "This substantial capital commitment from Hercules aims to assist X4 in further advancing its important mission of developing and commercializing novel therapies for the treatment of rare diseases of the immune system."

The term loan facility provides for up to $115 million of term loans in the aggregate, available to be funded in multiple tranches. In addition to its initial drawdown, X4 may, for a period of time following U.S. approval of mavorixafor in individuals with WHIM syndrome, draw an additional tranche of up to $20 million. An additional tranche will be available to X4 in the amount of up to $7.5 million for a period of time following achievement of a certain clinical development-related milestone. The availability of a final tranche of up to $32.5 million in support of X4’s growth initiatives is subject to the approval of the lenders. In addition, the availability of each tranche is subject to certain customary conditions to drawing. The facility refinances $32.5 million in outstanding principal indebtedness and extends the initial interest-only period and maturity of existing and future borrowings. X4 is under no obligation to draw funds in the future.

On August 3, 2023 Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) reported an expansion of the Global Business Partnership Agreement ("GBPA") with Roche Diagnostics International Ltd. (HQ: Rotkreuz, Switzerland) ("Roche"), the diagnostic business unit of F. Hoffmann-La Roche Ltd (HQ: Basel, Switzerland), with the purposes of addressing long-term issues in providing additional value to customers in laboratories and realizing a sustainable society (Press release, Sysmex, AUG 3, 2023, View Source [SID1234633778]). The expanded GBPA includes the renewal of the non-exclusive Total Laboratory Solution Collaboration Agreement concerning projects in which customers desire to purchase products for clinical chemistry, immunochemistry, and hematology testing from one vendor, as well as the addition of the Eco-Social Collaboration Agreement to begin considering collaborative themes for addressing social issues.

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In 1998, Sysmex entered into a Global Collaboration Agreement with Roche for mutual sales of their products, and cooperation between their respective R&D and IT businesses. In the 25 years since, the two companies have built a solid partnership through an evolution of their relationship in response to environmental changes and complementing each other, such as in product portfolios and sales and service networks. More recently, in 2020, the two companies signed the GBPA to define the collaborative framework between the two.1

In recent years, clinical laboratories have been facing increasingly diverse and complex challenges. These challenges include the need for healthcare efficiency and quality improvement driven by factors such as aging population and advancements in medical technology. Additionally, there is a growing demand to strengthen the healthcare infrastructure in response to the spread of COVID-19 infections. Also, there are increasing expectations on companies to help solve social issues, such as climate change, environmental issues, and disparities in healthcare to realize a sustainable society.

Sysmex has agreed with Roche to expand the scope of their collaboration to include not only their products and sales and services, but also the creation of a circular resource value chain in the in vitro diagnostics domain to deliver greater value to customers in laboratories from an "eco-social" perspective, which aims to strengthen the links between corporate activities and solutions to social issues.

"We are pleased to announce the renewal of our partnership with Roche, reaffirming our commitment to long-term collaboration. Developing our partnerships in the field of diagnostics even further and addressing enduring eco-social challenges represents a significant milestone in advancing our alliance to the next level. Together, we firmly believe in making even greater contributions to our customers in laboratories and creating a sustainable society," said Kaoru Asano, President of Sysmex Corporation.

"We are delighted to expand our 25-year partnership with Sysmex in the area of hematology and in exploring more sustainable diagnostics solutions. Roche and Sysmex both have a long-standing history of delivering reliable and innovative solutions for patients and I am very happy to see this collaboration grow," said Matt Sause, CEO of Roche Diagnostics.

Going forward, Sysmex will endeavor to continue providing high-value products and services that exceed customer expectations, while creating new value toward solving social issues, through collaboration with Roche over the medium- to long-term, which involves sharing their individual management resources and complementing supply chains.

On August 3, 2023 Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the quarter ended June 30, 2023, and provided a business update (Press release, Syndax, AUG 3, 2023, View Source [SID1234633777]).

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"On the heels of recently reported positive data from our pivotal AGAVE-201 trial of axatilimab in chronic graft-versus-host disease, we remain on track to achieve several additional important milestones for both of our programs in what is proving to be a transformational year for Syndax," said Michael A. Metzger, Chief Executive Officer. "The AGAVE-201 data underscore axatilimab’s ability to provide meaningful benefit to patients suffering from cGVHD, and we are working with our partners at Incyte to potentially submit a BLA filing by the end of 2023."

Mr. Metzger added, "Additionally, we remain on track to report topline pivotal data from the KMT2Ar cohorts of the Phase 2 AUGMENT-101 trial of revumenib for acute leukemias this quarter, followed by a potential NDA filing by the end of this year. We continue to be focused on executing our robust clinical development plans for both axatilimab and revumenib to fully realize their potential as best-in-class medicines."

Recent Pipeline Progress and Anticipated Milestones

Revumenib

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The pivotal Phase 2 portion of AUGMENT-101 is enrolling relapsed/refractory (R/R) patients across distinct trial populations: patients with nucleophosmin mutant (mNPM1) acute myeloid leukemia (AML), patients with KMT2Ar AML, and patients with KMT2Ar acute lymphocytic leukemia (ALL). The Company expects to share topline data from a pooled analysis of the KMT2Ar cohorts in the third quarter of 2023 and submit a New Drug Application (NDA) filing by the end of 2023. The Company also expects to complete enrollment of the mNPM1 AML cohort by year-end 2023.

•
The Company has several trials of revumenib ongoing across the treatment landscape in mNPM1 and KMT2Ar acute leukemias that include the following:

o
BEAT-AML: Evaluating the combination of revumenib with VENCLEXTA and azacitidine in front-line AML patients, being conducted as part of the Leukemia & Lymphoma Society’s Beat AML Master Clinical Trial. The Company expects to receive initial safety data at a potential recommended Phase 2 dose (RP2D) by year-end 2023.
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SAVE: Evaluating the combination of revumenib with VENCLEXTA and INQOVI in R/R AML or mixed phenotype acute leukemias. The trial is being conducted by investigators from the MD Anderson Cancer Center.
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AUGMENT-102: Evaluating the combination of revumenib with chemotherapy in patients with R/R acute leukemias. The Company expects to provide an update on initial safety data along with the RP2D from the trial by year-end 2023.
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INTERCEPT: Evaluating revumenib as a monotherapy in patients with AML who are minimal residual disease-positive following initial treatment as part of the INTERCEPT AML Master Clinical Trial.
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The Company plans to initiate a trial of revumenib with 7+3 cytarabine and daunorubicin chemotherapy followed by maintenance treatment in newly diagnosed patients with mNPM1 or KMT2Ar acute leukemias by year-end 2023.
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A proof-of-concept clinical trial of revumenib in patients with unresectable metastatic microsatellite stable colorectal cancer is enrolling patients, and the Company expects to provide an update on the Phase 1 trial by year-end 2023.

Axatilimab

•
In July 2023, the Company and its partner, Incyte, announced positive topline data from the pivotal Phase 2 AGAVE-201 trial of axatilimab, Syndax’s anti-CSF-1R antibody, in patients with chronic graft-versus-host disease (cGVHD) following two or more prior lines of therapy. All three dose cohorts, 0.3 mg/kg every two weeks, 1.0 mg/kg every two weeks and 3.0 mg/kg every four weeks, met the primary endpoint by demonstrating overall response rate within the first six months of treatment of 74%, 67% and 50%, respectively (95% Confidence Interval [CI]: [63,83], [55,77] and [39,61], respectively). Responses were durable and accompanied by a reduction in symptom burden in a notably advanced and heavily pretreated patient population. Furthermore, axatilimab was generally well tolerated and the most common adverse events were consistent with on target effects and prior trials. Syndax and Incyte expect to submit a Biologics License Application (BLA) filing by year-end 2023, pending agreement from regulatory authorities.
•
Incyte and Syndax expect to initiate a trial assessing axatilimab in combination with Jakafi in cGVHD by year-end 2023.
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The Company expects to initiate a randomized, double-blind and placebo-controlled Phase 2 trial that assesses the efficacy, safety and tolerability of axatilimab in patients with idiopathic pulmonary fibrosis (IPF) by year-end 2023.

Second Quarter 2023 Financial Results

As of June 30, 2023, Syndax had cash, cash equivalents, short- and long-term investments of $418.3 million and 69.7 million common shares and prefunded warrants outstanding.

Second quarter 2023 research and development expenses increased to $34.8 million from $29.7 million for the comparable prior year period. The increase in research and development expenses was primarily due to increased employee-related expenses, professional fees and clinical expenses, partially offset by decreased manufacturing activities.

Second quarter 2023 general and administrative expenses increased to $14.9 million from $8.0 million for the comparable prior year period. The increase is primarily due to employee-related expenses and professional fees.

For the three months ended June 30, 2023, Syndax reported a net loss attributable to common stockholders of $44.6 million, or $0.64 per share, compared to a net loss attributable to common stockholders of $37.6 million, or $0.62 per share, for the comparable prior year period.

Financial Update and Guidance

For the third quarter of 2023, the Company expects research and development expenses to be $39 to $43 million and total operating expenses to be $57 to $62 million. For the full year of 2023, the Company continues to expect research and development expenses to be $160 to $175 million and total operating expenses to be $225 to $240 million.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, August 3, 2023.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website. Alternatively, the conference call may be accessed through the following:

Conference ID: SNDX2Q23
Domestic Dial-in Number: 800-245-3047
International Dial-in Number: 203-518-9765
Live webcast: https://www.veracast.com/webcasts/syndax/events/SNDX2Q23.cfm

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.

On August 3, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the second quarter ended June 30, 2023, and provided recent business updates (Press release, Sensei Biotherapeutics, AUG 3, 2023, View Source [SID1234633776]).

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"The second quarter of 2023 was momentous for Sensei as we moved expeditiously from the FDA’s clearance of our SNS-101 trial in April to the enrollment of six patients by the end of July. We’re encouraged by the rapid clinical enrollment activity we’ve observed so far, which suggests that we may be able to accelerate the start of the combination arm of this study," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "We’re grateful for the efforts of the clinical investigators, patients, and families without whom this clinical trial would not be possible."

Highlights and Milestones

SNS-101

Sensei’s lead investigational candidate is SNS-101, a conditionally active antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), which is implicated in numerous cancer indications and whose expression correlates with low survival rates.

Recent updates for SNS-101 include:

An Investigational New Drug (IND) application for SNS-101 was cleared by the U.S. Food and Drug Administration (FDA) in April 2023. The cleared starting dose of 0.3 mg/kg was substantially higher than other anti-VISTA antibodies.
On June 1, 2023, Sensei reported the first patient dosed in the dose escalation portion of the SNS-101 multi-center Phase 1/2 clinical trial. To date, Sensei has enrolled a total of 6 patients, clearing its first patient cohort at 0.3 mg/kg and its second patient cohort at 1.0 mg/kg, and is currently dosing patients in its third cohort at 3.0 mg/kg.
As a result of the pace of enrollment to date, Sensei expects to dose the first patient in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in Q4 2023.
Sensei now expects to report initial pharmacokinetic (PK) and safety data by year-end 2023, and topline monotherapy data and initial combination data for the Phase 1/2 clinical trial in 2024.
On June 27, 2023, Sensei provided an overview of SNS-101 and its Phase 1/2 clinical trial in a virtual KOL event entitled "A New VISTA for Cancer Care: Exploring SNS-101’s Potential as a Transformative Treatment Option for Patients with Solid Tumors." A link to the event recording can be accessed on the Sensei website. For this event, Sensei welcomed James Gulley, M.D., Ph.D., Co-Director of the Center for Immuno-Oncology, and Clinical Director at the National Cancer Institute (NCI), part of the National Institutes of Health, to provide an overview of today’s immuno-oncology treatment landscape and discuss NCI’s Cooperative Research & Development Agreement (CRADA) with Sensei, which includes ongoing research to further elucidate the role of VISTA in immune checkpoint resistance, research to expand the potential of SNS-101 as a combination therapy beyond anti-PD-1, and NCI serving as a clinical site for the SNS-101 Phase 1/2 clinical trial.
Other TMAb Platform Updates

Through its Tumor Microenvironment Activated biologics (TMAb) platform, Sensei is advancing several conditionally active antibody programs, including SNS-102 targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), SNS-103 targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1, also known as CD39) and a recently initiated bispecific antibody program.

Recent updates include:

Sensei has completed lead optimization for its programs SNS-102 (targeting VSIG4) and SNS-103 (targeting CD-39) and is currently characterizing potential lead antibodies for each program. Sensei remains on track to select product candidates for both SNS-102 and SNS-103 in 2023.
Sensei’s early discovery bispecific antibody program has generated an initial set of conditionally active bispecific antibodies that are currently being characterized.
Upon successful candidate selection, Sensei expects to advance one product candidate to IND-enabling studies.
Additional Updates

Robert Schreiber, Ph.D., Professor of Pathology & Immunology and Director of the Center for Human Immunology and Immunotherapy Programs at Washington University, has been appointed Chair of Sensei’s Immuno-Oncology Advisory Board. Dr. Schreiber was largely responsible for defining the concept of cancer immunoediting and his research focuses on elucidating the biochemistry and molecular cell biology of immune responses to developing and established tumors. He is an expert on VISTA, the target of Sensei’s lead program SNS-101, and his laboratory at Washington University in St. Louis, MO has partnered with Sensei to support the continued clinical development of SNS-101.

Second Quarter 2023 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $78.8 million as of June 30, 2023, as compared to $107.1 million as of December 31, 2022. The decrease is due to cash used to fund operations and $7.8 million relating to shares repurchased within the period. Sensei expects its current cash balance to fund operations into the second half of 2025.

Research and Development (R&D) Expenses: R&D expenses were $4.8 million for the quarter ended June 30, 2023, compared to $6.4 million for the quarter ended June 30, 2022. The decrease in R&D expenses was primarily attributable to lower personnel costs due to the Company’s December 2022 restructuring, lower expense relating to lab supply purchases and lower manufacturing-related expenses, partially offset by increased expense relating to outside research fees and higher expense associated with clinical trials.

General and Administrative (G&A) Expenses: G&A expenses were $5.4 million for the quarter ended June 30, 2023, compared to $4.3 million for the quarter ended June 30, 2022. The increase in G&A expense was primarily attributable to external professional services, including $1.56 million of non-recurring expenses associated with stockholder activism related to our 2023 annual meeting of stockholders, partially offset by lower recruiting expense.

Net Loss: Net loss was $9.4 million for the quarter ended June 30, 2023, compared to $10.5 million for the quarter ended June 30, 2022.