On November 9, 2023 ImmVira reported the successful completion of Phase I clinical study conducted on late-stage patients with various tumor types for our intravenous oncolytic product, MVR-T3011 IV, in the United States (Press release, Immvira, NOV 9, 2023, View Source [SID1234637444]). This milestone was marked by the product’s exceptional safety results and preliminary efficacy for certain indications. Concurrently, a series of comprehensive pharmacokinetics/pharmacodynamics (PK/PD) and immune responses research were also conducted, generating valuable firsthand data to guide the forthcoming Phase II clinical study.

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As of October 31, 2023, 17 patients (17/18, 94.4%) experienced Treatment-Emergent Adverse Events (TEAEs), with 16 patients (16/18, 88.89%) reporting drug-related Treatment-Related Adverse Events (TRAEs). Notably, all of these adverse events were of grade 1 or 2 severity, and no TRAEs of grade 3 or higher were observed. TEAEs with an incidence of over 20% included abdominal pain (4/18, 22.2%), urinary tract infection (5/18, 27.28%), nausea (6/18, 33.3%), hypokalaemia (4/18, 22.2%) and hypotension (6/18, 33.3%). 7 patients (7/18, 38.89%) experienced Serious Adverse Events (SAEs), none of which were drug-related.

Overall, MVR-T3011 IV showed great safety profile at Phase I clinical study. Currently, there are 12 evaluable patients. According to RECIST 1.1, patients with endometrial, appendiceal, and gallbladder cancer demonstrated a significant reduction in tumor burden. The maximum reduction exceeded 15% compared to the baseline.

Simultaneously, Company is conducting a series of clinical exploratory studies in China for multiple tumor types. By combining PK/PD data from Phase I clinical study in both the U.S. and China, our goal is to devise a development strategy for a registrational Phase II clinical study targeting real unmet clinical needs.

Chairwoman and CEO Dr. Grace Guoying Zhou said that, "The development of intravenously administered oncolytic virus products has long been a challenging bottleneck. Oncolytic viruses must overcome numerous hurdles, such as neutralization by antibodies or the risk of cytokine storms, in order to effectively reach tumor sites with a sufficient number of viruses to achieve anti-tumor effects. With the successful Phase I clinical study results of MVR-T3011 IV, global first clinical-stage intravenous oHSV product, our company is now fully confident and committed to expediting clinical explorations in colorectal cancer, non-small cell lung cancer, and other indications, including combination treatments with immune checkpoint inhibitor or chemotherapy. Our goal is to bring the benefits of intravenous oncolytic virotherapy to cancer patients as swiftly as possible."

About MVR-T3011

MVR-T3011, ImmVira’s proprietary 3-in-1 oHSV, is a novel genetically engineered oHSV, which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells. Its incorporation of two latest and well-validated exogenous genes, PD-1 antibody and IL-12, further enhances immune responses in the tumor microenvironment.

On November 9, 2023 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported its financial and operating results for the quarter ended September 30, 2023 (Press release, AEterna Zentaris, NOV 9, 2023, View Source;b=2533&ID=128359&m=rl&g=1592 [SID1234637443]).

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"We are pleased with the progress made in the last quarter with respect to the commercialization of Ghryvelin (macimorelin and previously sold in the United States as Macrilen) in the European Economic Area (EEA). Following regional pricing approvals, Pharmanovia, our commercialization partner in the EEA, has launched Ghryvelin in the UK, Germany, Scandinavia and other countries in the EEA, and is expecting to launch Ghryvelin in additional countries in the EEA during the remainder of 2023 and into the first half of 2024. In South Korea, Macrilen granules received MFDS approval in September so that, together with our partner NK Meditech, we are now preparing to launch Macrilen in the South Korean market," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "We are also encouraged with the progress we are making with our ongoing research program involving the use of the AIM biologics platform to treat neuromyelitis optica spectrum disorder (NMOSD) where we achieved ex-vivo proof of mode of action by regulatory T-Cell activation in human peripheral blood mononuclear cells of healthy donors and NMOSD patients. Our efforts to advance our programs are supported by our strong cash position which we believe enables us to meet our currently projected cash needs into 2025."

Summary of Third Quarter 2023 Financial Results

All amounts are in U.S. Dollars

Cash and cash equivalents

The Company had $38.8 million in cash and cash equivalents at September 30, 2023.

Results of operations for the three-month period ended September 30, 2023

For the three-month period ended September 30, 2023, we reported a consolidated net loss of $4.1 million, or $0.85 loss per common share (basic and diluted), as compared with a consolidated net loss of $3.4 million, or $0.70 loss per common share (basic) for the three-month period ended September 30, 2022.

Revenues

Our total revenue for the three-month period ended September 30, 2023, was $0.0 million as compared with $1.9 million for the same period in 2022, representing a decrease of $1.9 million. The decrease was due to required transition time in onboarding our new partner, Pharmanovia, as it pertained to marketing Ghryvelin in the European Economic Area and United Kingdom, as well as the termination of the Company’s amended agreement with Novo Nordisk Healthcare in May 2023.
Operating Expenses

Our total operating expenses for the three-month period ended September 30, 2023 were $4.6 million as compared with $5.6 million for the same period in 2022, representing a decrease of $1.0 million. This decrease arose from a $0.5 million decrease in research and development expenses, related to a decrease of $0.4 million in our AEZS-130 Macimorelin ALS project and a net decrease of $0.1 million for all other projects, as well as a $0.5 million decrease in the selling, general & administrative expenses.
Net Finance Income

For the three-month period ended September 30, 2023, our net finance income was $0.4 million as compared to $0.3 million for the three-month period ended September 30, 2022, representing an increase of $0.1 million. This was primarily due to an increase in interest earned on bank deposits of $0.4 million offset by a $0.3 million decrease in our gain (loss) due to changes in foreign currency.
Results of operations for the nine-month period ended September 30, 2023

For the nine-month period ended September 30, 2023, we reported a consolidated net loss of $10.9 million, or $2.25 loss per common share (basic and diluted), as compared with a consolidated net loss of $10.3 million, or $2.12 loss per common share (basic) for the nine-month period ended September 30, 2022.

Revenues

Our total revenue for the nine-month period ended September 30, 2023, was $4.4 million as compared to $3.2 million for the same period in 2022, representing an increase of $1.2 million. The increase was due to an increase in license fee revenue recognized of $0.7 million and development services revenue of $0.7 million relating to the Company’s amended agreement with Novo Nordisk Healthcare, offset by a combined $0.2 million decrease in all other revenues.
Operating Expenses

Our total operating expenses for the nine-month period ended September 30, 2023 were $16.0 million as compared with $14.4 million for the same period in 2022, representing an increase of $1.6 million. This increase was due to a $1.6 million increase in research and development expenses, primarily related to a $0.9 million increase in the DETECT trial, a $0.5 million increase in our AEZS-130 Macimorelin ALS project and a $0.4 million increase in our AIM-Biologicals – NMOSD project offset by a decrease of approximately $0.4 million for all other projects.
Net Finance Income

For the nine-month period ended September 30, 2023, our net finance income was $0.7 million as compared to $1.0 million for the nine-month period ended September 30, 2022, representing a decrease of $0.3 million. This decrease was the result of a $1.0 million decrease in gains due to changes in foreign currency rates offset by a $0.7 million increase in interest income.
Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Company’s Management’s Discussion and Analysis of Financial Condition and Results of Operations for the third quarter 2023, as well as the Company’s unaudited consolidated interim financial statements as of September 30, 2023, will be available on the Company’s website (www.zentaris.com) in the Investors section or at the Company’s profile at www.sedarplus.com and www.sec.gov.

On November 9, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported that the first patient has been dosed in the Phase 1b clinical trial of PH-762, an INTASYL compound that reduces the expression of PD-1, a protein that inhibits T cells’ ability to kill cancer cells (Press release, Phio Pharmaceuticals, NOV 9, 2023, View Source [SID1234637441]). This clinical trial is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or dose range for continued study of PH-762 in patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma.

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"The initiation of enrollment in this trial represents a milestone as we develop PH-762 for the treatment of squamous cell and other skin cancers," said Phio’s President and CEO Robert Bitterman. "We are optimistic that this novel, alternative immuno-oncology therapy may offer patients and their care providers, enhanced therapeutic outcomes while minimizing invasive intervention."

The Phase 1b trial is a non-comparative study of neoadjuvant monotherapy using PH-762 in adult patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. The study treatment consists of four intratumoral injections of PH-762 at weekly intervals within a single tumor lesion. Excision of the tumor occurs approximately two weeks following the fourth intratumoral dose of PH-762. Escalating doses of PH-762 are to be tested in separate cohorts. The clinical study is expected to enroll up to 30 patients and will be conducted across 4 to 6 centers in the United States. More information about this clinical trial is available at clinicaltrials.gov (identifier: NCT06014086).

On November 9, 2023 aTyr Pharma, Inc. (Nasdaq: LIFE) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported third quarter 2023 results and provided a corporate update (Press release, aTyr Pharma, NOV 9, 2023, View Source [SID1234637440]).

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"During the third quarter we made meaningful progress with our clinical development program for our lead therapeutic candidate, efzofitimod, in interstitial lung disease (ILD)," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "We had a positive data and safety monitoring board (DSMB) review for our global pivotal Phase 3 EFZO-FIT study in patients with pulmonary sarcoidosis, a major form of ILD with high unmet medical need. This study continues to enroll in the U.S., Europe and Japan and based on current projections, we expect to complete enrollment in this study early in the second quarter of 2024. Additionally, we dosed the first patient in our Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD), which is currently enrolling in the U.S."

Third Quarter 2023 and Subsequent Period Highlights

Continued enrollment in the global pivotal Phase 3 EFZO-FIT study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12 doses. The study intends to enroll up to 264 subjects with pulmonary sarcoidosis. The study is open for enrollment at nearly all of the centers intended in the U.S., Europe and Japan and is expected to expand to include centers in Brazil. Based on current enrollment projections, the Company expects to complete enrollment in the study early in the second quarter of 2024.
Completed a positive DSMB review for the Phase 3 EFZO-FIT study. Data from the pre-planned, interim analysis of safety and tolerability of efzofitimod in patients with pulmonary sarcoidosis, which included the evaluation of patients who completed treatment, was evaluated. There were no drug-related serious adverse events, consistent with prior studies. The DSMB assessed that the study could continue unmodified and that the drug does not pose any undue risk to the patient that warrants additional safety measures.
Dosed the first patient in the Phase 2 EFZO-CONNECT study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with SSc-ILD. This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of 6 doses. The study intends to enroll 25 patients at multiple centers in the U.S. The primary objective of the study is to evaluate the efficacy of multiple doses of intravenous efzofitimod on pulmonary, cutaneous and systemic manifestations in patients with SSc-ILD.
Peer-reviewed article for efzofitimod published in the journal Frontiers in Pharmacology. The publication, titled, "Exposure-response analyses of efzofitimod in patients with pulmonary sarcoidosis," highlights a positive exposure response demonstrated by efzofitimod across multiple clinically relevant endpoints in the Phase 1b/2a study in patients with pulmonary sarcoidosis.
Presented two posters for efzofitimod at the European Respiratory Society (ERS) International Congress 2023. The posters presented new data from a pooled, post hoc analysis from the Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis that further demonstrates efficacy and findings that identify the expression of neuropilin-2 (NRP2), efzofitimod’s binding partner, in the skin of patients with SSc-ILD.
Poster for efzofitimod accepted for presentation at the upcoming American College of Rheumatology (ACR) Convergence 2023. The conference is scheduled to take place November 10 – 15, 2023, in San Diego, CA. The poster presents new data demonstrating the effects of efzofitimod in preclinical models of rheumatoid arthritis (RA) and RA-associated lung fibrosis.
Poster 1322 – Efzofitimod, a First-in-Class NRP2-targeting Immunomodulator, Ameliorates Rheumatoid Arthritis and Associated Lung Fibrosis in Preclinical Models on Monday, November 13, 2023, from 9:00 a.m. to 11:00 a.m. PST.
Third Quarter 2023 Financial Highlights and Cash Position

Cash & Investment Position: Cash, restricted cash, cash equivalents and investments as of September 30, 2023, were $105.6 million. Based on the Company’s current operational plans and existing cash, the Company updates its prior guidance and believes its cash runway will be sufficient to fund the Company’s operations through the filing of a Biologics License Application (BLA) for efzofitimod in pulmonary sarcoidosis.
R&D Expenses: Research and development expenses were $10.3 million for the third quarter of 2023, which consisted primarily of clinical trial costs for the Phase 3 EFZO-FIT and Phase 2 EFZO-CONNECT studies, manufacturing costs for the efzofitimod program and research and development costs for the efzofitimod and discovery programs.
G&A Expenses: General and administrative expenses were $2.6 million for the third quarter of 2023.
Collaboration and License Revenue: Collaboration and license revenue related to the Kyorin Agreement was $0.4 million for the third quarter of 2023, which consisted of drug product material sold to Kyorin for the Japan portion of the EFZO-FIT study.
About Efzofitimod

Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

On November 9, 2023 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, 2023 (Press release, Xilio Therapeutics, NOV 9, 2023, View Source [SID1234637429]).

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"Colorectal cancer is the third largest solid tumor cancer in terms of number of patients diagnosed annually and the second leading cause of cancer-related deaths globally," said René Russo, Pharm.D., president and chief executive officer of Xilio. "Rates of MSS colorectal cancer are rising in younger people, particularly in men under 50 years old, and patients often present with advanced Stage 4 disease along with liver metastases. Despite these alarming trends, there are few treatment options and no approved immunotherapies for these patients today. We believe the unique tumor-selective mechanism of XTX101 combined with atezolizumab has the potential to treat MSS colorectal cancer, and we are focused on initiating the co-funded collaboration with Roche to study this combination in patients. We are also encouraged by the recent Phase 1/2 data reported at SITC (Free SITC Whitepaper) for XTX202 demonstrating a 50% disease control rate at higher doses (≥2.8 mg/kg), including patients with cold tumors, and a generally well-tolerated safety profile across all dose levels. We look forward to evaluating the 4 mg/kg dose for XTX202 in Phase 2 for patients with melanoma and renal cell carcinoma."

Pipeline and Business Updates

XTX101: tumor-activated, Fc-enhanced anti-CTLA-4

XTX101 is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 designed to block CTLA-4 and deplete regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). XTX101 is currently being evaluated at the recommended Phase 2 dose and schedule of 150 mg once every six weeks in monotherapy dose expansion of an ongoing Phase 1 clinical trial in patients with advanced solid tumors.

● In the third quarter of 2023, Xilio reported updated data from the Phase 1 trial for XTX101, including an ongoing durable confirmed partial response through 36 weeks as of an August 3, 2023 data cutoff date in a patient with Stage 4 non-small cell lung cancer treated with XTX101 monotherapy, including resolution of liver metastases.
● Additionally, Xilio recently reported pharmacokinetic (PK) data showing activation of XTX101 in two on-treatment biopsies from patients in the Phase 1 trial, which included a primary melanoma tumor and a metastatic lesion in the liver from a patient with microsatellite stable colorectal cancer (MSS CRC). For both patients, XTX101 was more than 70% activated in the tumor while maintaining a peripheral activation level of 13%, consistent with the tumor-selective design for XTX101.
● In the third quarter of 2023, Xilio entered into a clinical trial collaboration with Roche to evaluate XTX101 in combination with atezolizumab in Phase 1 combination dose escalation in patients with advanced solid tumors and a planned Phase 2 trial in patients with MSS CRC. Xilio anticipates activating clinical trial sites for the Phase 1 combination dose escalation in the fourth quarter of 2023.
In addition, subject to obtaining sufficient additional capital, Xilio plans to:

● Complete Phase 1 combination dose escalation and select a recommended Phase 2 dose for XTX101 in combination with atezolizumab in the second quarter of 2024.
● Subject to the results of Phase 1 combination dose escalation, initiate a Phase 2 trial for XTX101 in combination with atezolizumab in patients with MSS CRC in the third quarter of 2024.
● Report initial Phase 2 data for XTX101 in combination with atezolizumab in approximately 20 patients with MSS CRC in the fourth quarter of 2024 and in approximately 20 additional patients (40 patients total) in the first quarter of 2025.
XTX202: tumor-activated, engineered, beta-gamma biased IL-2

XTX202 is an investigational tumor-activated, engineered, beta-gamma biased IL-2 molecule designed to potently stimulate CD8+ effector T cells and natural killer (NK) cells without concomitant stimulation of regulatory T cells when activated (unmasked) in the TME. XTX202 is currently being evaluated in an ongoing Phase 1/2 clinical trial in patients with advanced solid tumors.

● In November 2023, Xilio announced initial Phase 1/2 monotherapy safety, PK, pharmacodynamic (PD) and anti-tumor activity data for XTX202 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting. As of a data cutoff date of October 26, 2023, these data included:
● Initial evidence of a dose-dependent increase in disease control rate (DCR) for XTX202 across all dose levels in a range of solid tumors, including cold tumors, with a 50% DCR in response-evaluable patients at higher doses (≥2.8 mg/kg) and a 31% DCR in response-evaluable patients across all dose levels, including a patient with Stage 4 MSS CRC with ongoing stable disease at 57 weeks and resolution of three out of four non-target lesions.
● No signs or symptoms of vascular leak syndrome were reported by investigators through the 4.0 mg/kg dose. In addition, XTX202 was generally well-tolerated with treatment-related adverse events (TRAE) primarily Grade 1 or 2 and no treatment discontinuations due to TRAEs.
● Preliminary PK analysis demonstrated tumor-selective activation of XTX202, including an approximately 40-fold higher concentration of activated XTX202 in the tumor as compared to peripheral blood based on an analysis of an on-treatment biopsy from a patient at the 2.8 mg/kg dose level, which demonstrated approximately 15% activated XTX202 in the tumor compared to <1% activated XTX202 in plasma across patients at the 2.8 mg/kg dose level.
● Consistent with IL-2 beta-gamma biology, preliminary PD analysis of four available on-treatment tumor samples showed an average increase >200% of CD8+ effector T cells in the tumor as compared to pre-treatment biopsies.
● For more information, read the press release here.
● As previously announced, XTX202 recently cleared dose level seven (4.0 mg/kg) in Phase 1 monotherapy dose-escalation, and Xilio recently opened enrollment at a second dose level of 4.0 mg/kg in the ongoing Phase 2 monotherapy trial for XTX202. Based on the initial monotherapy data for XTX202, Xilio also plans to explore opportunities for strategic partnerships to evaluate XTX202 as a combination therapy.
● Subject to obtaining sufficient additional capital, Xilio plans to report Phase 2 monotherapy data for XTX202 in approximately 20 patients treated at the 4.0 mg/kg dose with metastatic renal cell carcinoma (RCC) or unresectable or metastatic melanoma in the second quarter of 2024.
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 is currently dosing patients in monotherapy dose escalation of an ongoing Phase 1 clinical trial evaluating the safety and tolerability of XTX301 in patients with advanced solid tumors.
● As previously announced, Xilio anticipates reporting preliminary safety data from the Phase 1 clinical trial into the third dose level in the fourth quarter of 2023.
● Subject to obtaining sufficient additional capital, Xilio plans to report Phase 1 safety and PK/PD data for XTX301 in advanced solid tumors in the second half of 2024.
Corporate Highlights

● In September 2023, Xilio announced the promotions of Katarina Luptakova, M.D., to Chief Medical Officer and Scott Coleman, Ph.D., to Chief Development Officer.
Upcoming Presentations

Xilio will present a poster for XTX101 with updated preliminary Phase 1 data and outlining the planned Phase 2 trial design at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Annual Congress on December 6-8, 2023.

Title: Phase 1/2 study of XTX101, a masked, tumor-activated Fc-enhanced anti-CTLA-4 in patients with advanced solid tumors

Presentation Date and Time: Thursday, December 7, 2023, from 12:00 to 1:00 p.m. CET

Abstract number: 490

Third Quarter 2023 Financial Results

● Cash Position: Cash and cash equivalents were $59.8 million as of September 30, 2023, compared to $120.4 million as of December 31, 2022.
● Research & Development (R&D) Expenses: R&D expenses were $11.1 million for the quarter ended September 30, 2023, compared to $13.0 million for the quarter ended September 30, 2022. The decrease was primarily driven by decreased manufacturing and preclinical activities for XTX301 and a reduction of XTX101 costs due to a cost-sharing payment earned under the clinical trial collaboration with Roche. These decreases were partially offset by increases in clinical activities for XTX202 and XTX301, preclinical activities for other early programs and indirect research and development expenses.
● General & Administrative (G&A) Expenses: G&A expenses were $6.3 million for the quarter ended September 30, 2023, compared to $7.2 million for the quarter ended September 30, 2022. The decrease was primarily driven by a decrease in professional and consulting fees.
● Net Loss: Net loss was $16.7 million for the quarter ended September 30, 2023, compared to $19.8 million for the quarter ended September 30, 2022.
Financial Guidance

Xilio continues to anticipate that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the end of the second quarter of 2024.

About XTX101 (anti-CTLA-4) and the Phase 1 Monotherapy and Phase 1/2 Combination Clinical Trials

XTX101 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 (unmasked) in the tumor microenvironment (TME). The Phase 1 clinical trial is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX101 for the treatment of adult patients with advanced solid tumors. Xilio has completed monotherapy dose escalation (Part 1A) and is currently enrolling patients at the recommended Phase 2 dose and schedule of 150 mg once every six weeks in monotherapy dose expansion (Part 1B). Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

In addition, Xilio plans to evaluate the safety, tolerability and efficacy of XTX101 in combination with atezolizumab (Tecentriq) in the Phase 1/2 clinical trial. The Phase 1 portion is designed to assess the safety and tolerability of XTX101 in combination with atezolizumab in dose escalation in patients with advanced solid tumors. The planned Phase 2 portion is designed to evaluate the safety and efficacy of the combination in patients with microsatellite stable colorectal cancer (MSS CRC).

About XTX202 (IL-2) and the Phase 1/2 Clinical Trials

XTX202 is an investigational tumor-activated beta-gamma biased, engineered IL-2 molecule designed to potently stimulate CD8+ effector T cells and natural killer (NK) cells without concomitant stimulation of regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). The Phase 1 clinical trial for XTX202 is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX202 as a monotherapy in patients with advanced solid tumors. The Phase 2 clinical trial for XTX202 is a multi-center, open-label trial designed to evaluate the safety and efficacy of XTX202 as a monotherapy in patients with unresectable or metastatic melanoma and metastatic renal cell carcinoma who have progressed on standard-of-care treatment. Please refer to NCT05052268 on www.clinicaltrials.gov for additional details.

About XTX301 (IL-12) and the Phase 1 Clinical Trial

XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. The Phase 1 clinical trial for XTX301 is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.