On November 7, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the presentation of data pertaining to two programs, including preclinical proof-of-concept for a novel T cell engager Switch-DARPin in solid tumors, and comprehensive biomarker analyses from the completed Phase 1 clinical trial of MP0317 (Press release, Molecular Partners, NOV 7, 2024, View Source [SID1234647977]). Posters will be presented at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held November 8–10 in Houston, TX, with the following details:

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Title: Unlocking precision: a next generation multi-specific CD3 Switch-DARPin with enhanced function to tackle the current limitations of T cell engagers in ovarian cancer
Abstract & Poster Number: 842

Title: Comprehensive biomarker analyses from a Phase 1 study reveals marked tumor microenvironment modulation in patients with advanced solid tumors treated with MP0317, a FAP-localized CD40 agonistic DARPin
Abstract & Poster Number: 612

Timing & Location: November 9, 2024 at 9 am – 8:30 pm CT; Exhibit Halls AB

Both posters will be made available on Molecular Partner’s website in the Scientific Documents section.

"Our Switch-DARPin platform provides a novel approach to tumor-localized T-cell engagement and costimulation through its logic-gated on/off Switch mechanism. We are excited to have the opportunity to add this MoA to our validated CD3 T cell engager approach," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "We hope to open therapeutic avenues for co-stimulating T-cell engagers, by rendering them silent in the circulation and activating them at the tumor site."

CD3 Switch-DARPin: Preclinical proof-of-concept for T cell engager with enhanced function in solid tumors

The Switch-DARPin platform provides a logic-gated "on/off" function (the "Switch") to multispecific DARPin candidates leading to immune activation only in the presence of defined antigens. This allows targeting the immune activation to tumors, increasing both efficacy and safety and opening up new opportunities for cancer treatment. T cell engagers (TCE) are a powerful class of immuno-oncology therapies but have faced a range of challenges such as high toxicity and limited specificity, particularly against solid tumors. By employing a multi-specific Switch-DARPin, Molecular Partners aims to bring additional dimensions of safety and potency to the fundamental TCE mechanism.

The data to be presented at SITC (Free SITC Whitepaper) provide further validation of the Company’s Switch-DARPin platform and preclinical proof-of concept that conditional T cell activation in solid tumors is feasible, as exemplified in preclinical ovarian cancer models. The presented multi-specific Switch-DARPin molecule comprises DARPins targeting:

CD3, to engage and activate T cells
CD2, a co-stimulator of CD3 on T cells
Mesothelin, a notable tumor antigen overexpressed across several cancer types, including ovarian cancer, and used as anchoring target for the Switch-DARPin
And the Switch-DARPin, which binds either to the tumor antigen EpCAM or to the CD3 DARPin mentioned above. In a default state, the whole molecule is in closed state (or Switched off), masking the CD3 DARPin and preventing immune activation. When tumor antigens mesothelin and EpCAM are present, the Switch-DARPin "switches" to bind EpCAM instead of the CD3 DARPin, thereby freeing the CD3 DARPin and allowing it to bind and activate T cells. T cell activation is further enhanced through co-stimulation by the CD2 DARPin.
This CD3 Switch-DARPin molecule effectively induces potent tumor regression in vivo, with reduced cytokine release, a significant toxicity event for TCEs in the clinic, compared to an unmasked CD3 with CD2 co-stimulation. In addition, co-engagement of CD2 leads to sustained T cell activation and cytotoxic capacity. Finally, masking of CD3 prevents T cell activation in the absence of tumor antigens, hence potentially allowing for "silent" TCEs outside of tumors. Taken together, masking CD3 may reduce the risk of CRS and provide a better safety profile to TCEs.

MP0317: Comprehensive biomarker data further support CD40 activation locally in tumor microenvironment

MP0317 is a CD40 agonist designed to activate immune cells specifically within the tumor microenvironment (TME) by anchoring to fibroblast activation protein (FAP) which is expressed in high amounts in the stroma of various solid tumors. This tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

The poster presents the results of a comprehensive biomarker analyses from the completed Phase 1 multi-center, open label, dose-escalation trial of MP0317 monotherapy in patients with advanced solid tumors. The research further demonstrates the ability of MP0317 to induce a targeted, tumor-localized CD40 activation and its suitability for Q3W (every three weeks) and Q1W (weekly) dosing. The CD40 pathway is activated in a broad-spectrum of cancer types and various tumor locations. Evidence of TME remodeling in patients treated with pharmacologically active doses is exemplified by increases in dendritic cells, M1 macrophages, plasma cells, and T follicular helper cells, as well as IFNγ downstream activation and an increased dendritic cell maturation gene signature score. Peripheral pharmacodynamic effects aligned with the MP0317 mode of action are also seen, including increases in CXCL10 chemoattractant, transient B-cell reduction, and activation in blood.

Molecular Partners is in discussion with leading academic centers regarding potential investigator-initiated combination trials of MP0317.

About DARPin Therapeutics
DARPin (Designed Ankyrin Repeat Protein) therapeutics are a new class of custom-built protein drugs based on natural binding proteins that open new dimensions of multi-functionality and multi-target specificity in drug design. The flexible architecture, intrinsic potential for high affinity and specificity, small size and high stability of DARPins offer benefits to drug design over other currently available protein-based therapeutics. DARPin candidates can be radically simple, with a single DARPin unit acting as the delivery vector to a specific target; or multispecific, with the possibility of engaging more than five targets, and combining multiple and conditional functionalities in a unique DARPin drug candidate. The DARPin platform is designed to be a rapid and cost-effective drug discovery engine, producing drug candidates with optimized properties and high production yields. DARPin therapeutics have been clinically validated across several therapeutic areas and developed through to the registrational stage.

On November 7, 2024 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, reported financial results and provided a business update for the three months ended September 30, 2024 (Press release, Rezolute, NOV 7, 2024, View Source [SID1234647969]).

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"Execution across our two Phase 3 programs in patients with congenital HI and tumor HI will be the focus going into 2025," said Nevan Elam, Chief Executive Officer and Founder of Rezolute. "We are pleased with the progress we’ve made in sunRIZE enrollment and look forward to advancing our Phase 3 study in tumor HI patients based on the success demonstrated in our Expanded Access Program. As a rare disease company with two late-stage clinical trials, we recognize how critical 2025 will be in progressing our programs in order to provide a potentially meaningful therapy for patients where limited options currently exist."

Recent Pipeline Progress and Anticipated Milestones

Congenital HI

· Ex-U.S. patient enrollment in sunRIZE, a global, pivotal Phase 3 clinical study for ersodetug in patients with congenital HI, is on track.
· Study start-up activities are underway for enrollment of U.S. participants in early 2025.
· Topline results from sunRIZE expected in the second half of 2025.

Tumor HI

· Start-up activities are progressing for the Phase 3 registrational study for ersodetug in patients with tumor HI.
· Patient enrollment anticipated to begin in the first half of 2025.
· Topline results expected in the second half of 2026.

Fiscal First Quarter Financial Results

Cash, cash equivalents and investments in marketable securities were $117.8 million as of September 30, 2024, compared to $127.1 million as of June 30, 2024.

Research and development expenses were $12.8 million for the first quarter of fiscal 2025, compared with $12.2 million for the same period a year ago, with the increase primarily attributable to increased expenditures in clinical trial activities, manufacturing costs and higher personnel-related expenses, which include employee compensation.

General and administrative expenses were $4.2 million for the first quarter of fiscal 2025, compared with $3.7 million for the same period a year ago, with the increase primarily attributable to professional fees and employee-related expenses as a result of increased headcount.

Net loss was $15.4 million for the first quarter of fiscal 2025 compared with a net loss of $14.5 million for the same period a year ago.

About Ersodetug

Ersodetug is a fully human monoclonal antibody that binds to a unique allosteric site on insulin receptors to counteract the effects of insulin receptor over-activation by insulin and related substances (such as IGF-2), thereby improving hypoglycemia in the setting of hyperinsulinism (HI). Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any form of HI.

About sunRIZE

The Phase 3 sunRIZE study is a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital HI who are experiencing poorly controlled hypoglycemia. Participants between the ages of 3 months to 45 years old are eligible to participate. The study is enrolling up to 56 participants in more than a dozen countries around the world.

On November 7, 2024 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the third quarter ended September 30, 2024 (Press release, Nektar Therapeutics, NOV 7, 2024, View Source [SID1234647968]).

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Cash and investments in marketable securities on September 30, 2024 were $249.0 million as compared to $329.4 million at December 31, 2023. Nektar’s cash and marketable securities are expected to support strategic development activities and operations into the fourth quarter of 2026.

"We made excellent progress this quarter advancing our I&I pipeline, including the ongoing Phase 2b studies of rezpegaldesleukin in atopic dermatitis and alopecia areata," said Howard W. Robin, President and CEO of Nektar. "We see rapid enrollment in the 400-patient atopic dermatitis study for rezpegaldesleukin, and we remain on track for topline data in the first half of 2025. Our Phase 2 study in alopecia areata is also enrolling nicely with topline data expected in the second half of 2025."

"Beyond rezpegaldesleukin, we are focused on advancing our earlier stage TNFR2 antibody and bispecific programs, NKTR-0165 and NKTR-0166, with at least one of these slated to enter the clinic next year," continued Robin. "Next week, we are looking forward to presenting highly promising data at the 2024 ACR Convergence Meeting for our preclinical PEG-CSF program, NKTR-422. Finally, we recently published important data for our IL-15 agonist, NKTR-255, highlighting its potential as a validated mechanism in oncology."

Summary of Financial Results

Revenue in the third quarter of 2024 was $24.1 million compared to the same $24.1 million in the third quarter of 2023. Revenue for the first nine months of 2024 was $69.3 million compared to $66.2 million in the first nine months of 2023.

Total operating costs and expenses in the third quarter of 2024 were $58.5 million compared to $69.0 million in the third quarter of 2023. Total operating costs and expenses in the first nine months of 2024 were $188.8 million compared to $296.4 million in the first nine months of 2023. Operating costs and expenses for the first nine months of 2024 decreased primarily due to decreases in restructuring, impairment and costs of terminated programs and a one-time $76.5 million non-cash goodwill impairment recognized in the first quarter of 2023.

R&D expense in the third quarter of 2024 was $35.0 million compared to $24.1 million for the third quarter of 2023. For the first nine months of 2024, R&D expense was $92.2 million compared to $84.2 million in the first nine months of 2023. R&D expense increased for both the third quarter and the first nine months of 2024 primarily due to increases in development expenses for rezpegaldesleukin and NKTR-0165, partially offset by decreases in employee and related facilities costs, as well as development expenses for NKTR-255.

G&A expense was $19.0 million in the third quarter of 2024 compared to $21.1 million in the third quarter of 2023. G&A expense was $59.6 million for the first nine months of 2024 compared to $60.1 million in the first nine months of 2023. G&A expense decreased for both the third quarter and the first nine months of 2024 primarily due to decreases in employee costs, partially offset by the reduction of facilities costs allocated to research and development expenses.

Non-cash restructuring and impairment charges were less than $0.1 million in the third quarter of 2024 and $14.3 million in the first nine months of 2024. These non-cash charges are related to the declining San Francisco commercial real estate market and real estate lease obligations held by Nektar.

Net loss for the third quarter of 2024 was $37.1 million or $0.18 basic and diluted loss per share compared to a net loss of $45.8 million or $0.24 basic and diluted loss per share in the third quarter of 2023. Net loss in the first nine months of 2024 was $126.2 million or $0.62 basic and diluted loss per share compared to a net loss of $234.0 million or $1.23 basic and diluted loss per share in the first nine months of 2023. Excluding the $14.3 million in non-cash restructuring and real estate impairment charges, net loss, on a non-GAAP basis, for the first nine months of 2024 was $111.9 million, or $0.55 basic and diluted loss per share.

Third Quarter 2024 and Recent Business Highlights

● In September 2024, Nektar presented several posters for rezpegaldesleukin (REZPEG) at the 2024 European Academy of Dermatology and Venereology (EADV) Congress. In addition to two trial-in-progress posters, new proteomic analyses were also presented, which showed that rezpegaldesleukin increased the protein levels of immune-regulating pathways and reduced specific serum proteins known to be elevated in patients with atopic dermatitis.

● In October 2024, Nektar and collaborators announced the publication of data from a Phase 1 trial evaluating NKTR-255 in combination with CD19/22 CAR-T cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) in Blood, an open-access journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The data show that eight out of nine patients (89%) achieved complete remission, all without detectable measurable residual disease (MRD).

● In October 2024, Nature Communications published results from Phase 1b studies of rezpegaldesleukin in two inflammatory skin diseases, demonstrating durable dose-dependent improvements in physician-assessed disease activity and patient-reported outcomes for both studies. Rezpegaldesleukin was evaluated in patients with moderate-to-severe atopic dermatitis (AD) (NCT04081350) or chronic plaque psoriasis (PsO) (NCT04119557). AD patients receiving high dose rezpegaldesleukin demonstrate an 83% improvement in EASI score after 12 weeks of treatment. EASI improvement of ≥ 75% (EASI-75) and vIGA-AD responses were maintained for 36 weeks after treatment discontinuation in 71% and 80% of week 12 responders, respectively. Results validate the role of IL-2-induced Treg proliferation and activation in the AD treatment paradigm, and support the advancement of rezpegaldesleukin in the Phase 2b study in AD.

● In November, Nektar announced a definitive agreement with Ampersand Capital Partners to sell its commercial PEGylation manufacturing business in Huntsville, Alabama for $90 million in enterprise value, which is comprised of $70 million in cash and $20 million in equity ownership in the new portfolio company. The Huntsville-based facility will be spun out as a standalone Ampersand portfolio company and Ampersand has committed to invest additional growth equity capital into the new company. All of Nektar’s employees at the Huntsville facility will be offered employment at the new portfolio company, ensuring continuity in the high-quality manufacturing and PEGylation expertise that longstanding customers trust and rely on. Nektar and the new Ampersand portfolio company will also enter into manufacturing supply agreements to meet Nektar’s PEG reagent needs for rezpegaldesleukin and certain pipeline programs. The transaction will be subject to customary closing conditions and costs and is expected to close by December 2, 2024. Following the closing, Nektar will retain all rights to current and future royalty streams and milestones related to existing PEGylated product license agreements. Nektar will also be entitled to appoint a representative to the board of the new Ampersand portfolio company

● Enrollment remains on track for the two Phase 2b studies of REZPEG, one in patients with moderate-to-severe atopic dermatitis and one in patients with severe to very severe alopecia areata. Nektar expects topline data from these studies in the first half and in the second half of 2025, respectively.

Nektar also announced presentations at the following medical meetings:

2024 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting

Late-breaking Abstract (LBA) 1489: " REStoring lymphoCytes Using NKTR-255 after chemoradiothErapy in solid tumors (RESCUE): Preplanned Interim Safety and Efficacy Analysis", Lin, S.

Presentation Type: Poster
ePoster will be on display on the SITC (Free SITC Whitepaper) 2024 virtual meeting platform on Thursday, November 7, 2024, at 9:00 a.m. CST

2024 American College of Rheumatology (ACR) Convergence

Abstract 1866120: "A Novel Therapeutically Active CSF-1R Agonist Promotes Tissue Macrophages Inflammation Resolution and Induces Tissue Repair Pathways", Kivimae, S.
Presentation Type: Oral
Session: Abstracts: Cytokines & Cell Trafficking
Presentation Time: Monday, November 18 at 3:15 PM – 3:30 PM

2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting

Abstract 203576: "NKTR-255 Vs Placebo to Enhance Complete Responses and Durability Following CD19-Directed CAR-T Therapy in Patients with Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL)", Ahmed, S.
Presentation Type: Poster
Session: Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities
Presentation Time: Saturday, December 7 at 5:30 PM – 7:30 PM

Conference Call to Discuss Third Quarter 2024 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on November 7, 2024.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through December 8, 2024.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

On November 7, 2024 XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its third quarter 2024 financial results and highlighted recent activities (Press release, Xoma, NOV 7, 2024, View Source [SID1234647954]).

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"We continue to take a balanced approach to building a portfolio of sustainable cashflow streams by selectively acquiring royalty economics across the lifecycle of drug development," stated Owen Hughes, Chief Executive Officer of XOMA Royalty. "The September approval of MIPLYFFA, the first therapy approved for patients living with Niemann-Pick disease Type C, adds to our growing commercial royalty portfolio, while the recent transaction with Twist Bioscience further expands our early-stage portfolio, a key focus for us as we look to distribute risk across a diversified portfolio."

Key Third Quarter Events

Partner Event
Zevra Therapeutics The U.S. Food and Drug Administration (FDA) approved Zevra’s MIPLYFFA (arimoclomol) capsules as an orally delivered treatment for Niemann-Pick disease type C (NPC). MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older.
Rezolute
Announced the sunRIZE Phase 3 clinical trial investigating ersodetug (RZ358) in patients with congenital hyperinsulinism (CHI) will begin enrolling patients in the U.S. in early 20251.

Received FDA clearance to initiate Phase 3 registrational study for ersodetug for the treatment of hypoglycemia due to tumor hyperinsulinism2.

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authorizes-u-s-inclusion-in-ongoing-phase-3-study

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Johnson & Johnson Presented neoadjuvant TAR-200 plus cetrelimab Phase 2 data in patients with muscle-invasive bladder cancer (MIBC) who are ineligible or refuse neoadjuvant platinum-based chemotherapy and are scheduled for radical cystectomy at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress3.
Subsequent Events

Partner Event
Twist Bioscience XOMA Royalty completed a $15 million royalty monetization agreement with Twist, acquiring 50% of the future milestones and royalties and adding 60-plus partnered early-stage programs across 30 companies enabled by Twist Bioscience’s Biopharma Solutions business unit to the XOMA Royalty portfolio.
Johnson & Johnson Announced one of two Phase 3 clinical trials in difficult to treat muscle-invasive bladder cancer (MIBC) that included treatment with cetrelimab was being discontinued for not showing superiority to chemoradiation during a scheduled interim analysis4. Cetrelimab continues to be investigated in multiple other clinical trials.
Anticipated 2024 Events of Note

Partner Event
Takeda On December 12, 2024, Takeda will be hosting an R&D Day: Focus on Late-State Pipeline and Market Opportunity and has commented publicly mezagitamab will be discussed during this investor event.
Third Quarter 2024 Financial Results

XOMA Royalty recorded total income and revenues of $7.2 million for the third quarter of 2024, which included $6.5 million in estimated income associated with two commercial products in our portfolio. In the third quarter of 2023, XOMA Royalty reported total income and revenue of $0.8 million.

Research and development (R&D) expenses were $0.8 million in the third quarter of 2024, reflecting transitory clinical trial costs related to KIN-3248, an asset acquired in the Kinnate acquisition, which the Company currently is winding down. R&D expenses in the third quarter of 2023 were $25,000.

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General and administrative ("G&A") expenses were $8.0 million for the third quarter of 2024 compared with $6.4 million in the third quarter of 2023. The increase of $1.6 million was primarily comprised of $1.4 million in total costs incurred after our acquisition of Kinnate, which included $1.1 million in legal and consulting costs, $0.1 million in information technology costs, and $0.1 million in insurance costs. The remainder of the increased G&A expense reflects an increase of $0.2 million for salaries and related costs.

In the third quarter of 2024, as a result of communications with Agenus, XOMA Royalty evaluated the status of the partnered programs underlying the Agenus Royalty Purchase Agreement for potential impairment and recorded a one-time, non-cash impairment charge of $14.0 million and a reduction of royalty receivables of $14.0 million associated with Agenus.

In the third quarters of 2024 and 2023, G&A expenses included $2.6 million and $2.7 million, respectively, in non-cash stock-based compensation expenses.

Total interest expense in the third quarter of 2024 was $3.5 million, representing interest and costs related to the Blue Owl Loan established in December 2023.

The Company reported total other income, net, of $1.9 million in the third quarter of 2024, as compared to total other income, net, of $0.3 million in the corresponding period of 2023. The $1.6 million increase reflects a $1.3 million increase in investment income due to higher balances on our investments and the change in the market price for XOMA Royalty’s shares of Rezolute common stock.

Net loss for the third quarter of 2024 was $17.2 million, compared to a net loss of $5.5 million for the third quarter of 2023, primarily resulting from the $14.0 million non-cash impairment related to the Agenus Royalty Purchase Agreement.

On September 30, 2024, XOMA Royalty had cash and cash equivalents of $146.8 million (including $4.8 million in restricted cash). On December 31, 2023, XOMA Royalty had cash and cash equivalents of $159.6 million (including $6.3 million in restricted cash). During the third quarter of 2024, XOMA Royalty received $9.9 million in cash from royalty and commercial payments. Net cash used in operating activities during the quarter was $8.6 million. On October 15, 2024, the Company paid a total of $1.4 million in cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) and the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO).

On November 7, 2024 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and announced financial results for the third quarter ended September 30, 2024 (Press release, Xilio Therapeutics, NOV 7, 2024, View Source [SID1234647953]).

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"Throughout the third quarter, our team continued to drive execution across all stages of our pipeline, including advancing our clinical development programs for vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, and XTX301, a tumor-activated IL-12, toward key data milestones and potential value inflection points," said René Russo, Pharm.D., president and chief executive officer of Xilio. "We look forward to sharing initial data from our Phase 1C dose escalation trial of vilastobart in combination with atezolizumab as part of a late-breaker poster presentation at the SITC (Free SITC Whitepaper) Annual Meeting. In addition, we continue to advance multiple promising research-stage programs, including XTX501, our tumor-activated PD-1/IL-2, and tumor-activated immune cell engagers."

Pipeline and Business Updates

Vilastobart (XTX101): tumor-activated anti-CTLA-4

Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME).

● Xilio will present initial Phase 1C dose escalation data for vilastobart in combination with atezolizumab in a late-breaker poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting taking place in Houston, Texas, from November 6-10, 2024.
● In addition, Xilio continues to enroll patients in its ongoing Phase 2 clinical trial evaluating vilastobart in combination with atezolizumab in patients with metastatic MSS CRC, including patients with and without liver metastases.
● Xilio expects to report initial Phase 2 data for vilastobart in combination with atezolizumab in approximately 20 patients with MSS CRC in the fourth quarter of 2024 and in a total of approximately 40 patients with MSS CRC in the first quarter of 2025.

XTX301: tumor-activated, engineered IL-12

XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic "cold" tumors towards an inflamed, or "hot," state.

● Xilio continues to enroll patients in Phase 1A monotherapy dose escalation and Phase 1B monotherapy dose expansion of its ongoing Phase 1 clinical trial of XTX301 in patients with advanced solid tumors.
● Xilio plans to report safety, pharmacokinetic and pharmacodynamic data from the ongoing Phase 1 clinical trial for XTX301 in the fourth quarter of 2024.

Tumor-Activated Bispecific and Immune Cell Engager Programs

Xilio is leveraging its proprietary platform to advance a pipeline of research-stage programs for tumor-activated bispecific and immune cell engager molecules, including tumor-activated immune cell engagers and tumor-activated effector-enhanced immune cell engagers.

● XTX501 is a tumor-activated bispecific PD-1/IL-2 designed to selectively stimulate PD-1 positive antigen-experienced T cells and enhance their function. XTX501 incorporates masking designed to overcome IL-2 receptor-mediated clearance and peripheral activity. Xilio is currently advancing initial investigational new drug (IND)-enabling activities for XTX501.
● Xilio will present preclinical data from its tumor-activated SELECTIVE EFFECTOR-ENHANCED CELL ENGAGER (SEECR) format in a poster session at the SITC (Free SITC Whitepaper) Annual Meeting. Details on the poster presentation can be found here.

Third Quarter 2024 Financial Results

● Cash Position: Cash and cash equivalents were $61.3 million as of September 30, 2024, compared to $44.7 million as of December 31, 2023.
● License Revenue: License revenue was $2.3 million for the quarter ended September 30, 2024, which consisted of revenue recognized under the license agreement and stock purchase agreement with Gilead. No license revenue was recognized for the quarter ended September 30, 2023.
● Research & Development (R&D) Expenses: R&D expenses were $10.8 million for the quarter ended September 30, 2024, compared to $11.1 million for the quarter ended September 30, 2023. The decrease was primarily driven by decreased clinical development activities for XTX202, a tumor-activated, IL-2, decreased spending related to early-stage programs and indirect research and development costs and decreased personnel-related costs, partially offset by increased clinical development activities for vilastobart and XTX301.
● General & Administrative (G&A) Expenses: G&A expenses were $6.3 million for
for each of the quarters ended September 30, 2024 and September 30, 2023.

● Net Loss: Net loss was $14.0 million for the quarter ended September 30, 2024, compared to $16.7 million for the quarter ended September 30, 2023.
Financial Guidance

Based on its current operating plans, Xilio anticipates that its existing cash and cash equivalents as of September 30, 2024, will be sufficient to fund its operating expenses and capital expenditure requirements through the end of the second quarter of 2025.

About Vilastobart (XTX101) and the Phase 1/2 Combination Clinical Trial

Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the safety and efficacy of the combination in Phase 2 in patients with metastatic microsatellite stable colorectal cancer with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

About XTX301 and the Phase 1 Clinical Trial

XTX301 is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. for Xilio’s tumor-activated IL-12 program, including XTX301. Xilio is currently evaluating the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors in a first-in-human, multi-center, open-label Phase 1 clinical trial. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.