On May 14, 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 first quarter ended March 31, 2024 (Press release, Xilio Therapeutics, MAY 14, 2024, View Source [SID1234643244]).

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"In the first quarter, our team remained hard at work advancing our differentiated pipeline of clinical-stage tumor-activated I-O therapies, and we believe we are well-positioned to execute on several anticipated near-term clinical milestones and potential value-drivers in the coming year," said René Russo, Pharm.D., president and chief executive officer of Xilio. "Looking ahead, we continue to focus on advancing the clinical development of XTX301, our tumor-activated IL-12, and XTX101, our tumor-activated, Fc-enhanced anti-CTLA-4, with clinical data from both programs expected later this year. In addition, we are encouraged by the progress we have made in our research-stage pipeline to design and develop tumor-activated bispecific and immune cell engager molecules."

Pipeline and Business Updates

XTX101: tumor-activated 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 in combination with atezolizumab in an ongoing Phase 1 clinical trial in patients with advanced solid tumors.

Xilio plans to:

● Select a recommended Phase 2 dose for XTX101 in combination with atezolizumab and initiate the Phase 2 portion of the trial 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.

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.

In March 2024, Xilio and Gilead Sciences, Inc. (Gilead) announced an exclusive license agreement for Xilio’s tumor-activated IL-12 program, including XTX301, and a stock purchase agreement with Gilead. Under the terms of the agreements:

● Xilio received $43.5 million in upfront payments, including a cash payment of $30.0 million and an initial equity investment by Gilead of approximately $13.5 million in Xilio common stock.
● In April 2024, Xilio received aggregate gross proceeds of approximately $3.3 million from an additional private placement with Gilead under the stock purchase agreement. Xilio is eligible to receive up to approximately $8.2 million in additional gross proceeds from up to two additional equity investments by Gilead.
● In addition to the equity investments by Gilead, Xilio is eligible to receive up to a total of $592.5 million in contingent payments under the license agreement, including a $75.0 million transition fee and specified development, regulatory and sales-based milestones. Xilio is also eligible to receive tiered royalties ranging from high single digits to mid-teens on annual global net product sales.

For more information, read the press release here.

XTX301 is currently being evaluated in Phase 1 monotherapy dose escalation in patients with advanced solid tumors. Xilio today reaffirmed plans to report Phase 1 safety, pharmacokinetic and pharmacodynamic data for XTX301 in patients with advanced solid tumors in the fourth quarter of 2024.

Tumor-activated bispecific and immune cell engager programs

Xilio’s research-stage development efforts are focused on advancing a pipeline of tumor-activated bispecifics and immune cell engagers, including tumor-activated cell engagers and tumor-activated effector-enhanced cell engagers.

● In April 2024, Xilio presented preclinical data from the company’s first bispecific program, XTX501, a tumor-activated PD-1/IL-2 bispecific development candidate, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 in San Diego, California. The preclinical data presented at AACR (Free AACR Whitepaper) suggest that XTX501 has the potential to improve upon the anti-tumor activity of existing PD-1/PD-L1 immunotherapies while maintaining a favorable therapeutic index. For more information, read the poster presentation here.

XTX202: tumor-activated, engineered IL-2

XTX202 is an investigational tumor-activated, beta-gamma biased IL-2 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.

● In March 2024, Xilio announced additional data from its Phase 2 clinical trial evaluating XTX202 in patients with metastatic renal cell carcinoma or unresectable or metastatic melanoma. For more information, read the press release here.
● In March 2024, Xilio also announced plans to discontinue further investment in XTX202 as a monotherapy as part of a strategic portfolio reprioritization. Xilio continues to explore strategic opportunities to continue to develop XTX202 in combination with other agents.

Upcoming Presentations

Xilio will present data from the Phase 1/2 trial for XTX202 in advanced solid tumors in a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois from May 31 to June 4, 2024.

Poster Title: Phase 1/2 study of XTX202, a tumor-activated IL-2βγ, in advanced solid tumors.

Session Name: Developmental Therapeutics—Immunotherapy

Abstract: 2595

Session Date and Time: June 1, 2024 at 9:00 am C.T. – 12:00 pm C.T.

Corporate Updates

● In March 2024, Xilio implemented a strategic portfolio prioritization designed to focus its resources on rapidly advancing clinical development for XTX301 and XTX101 and leveraging the company’s promising research platform to advance differentiated tumor-activated bispecific and immune cell engager molecules.
● In April 2024, Xilio closed a private placement equity financing with certain existing accredited investors, including Bain Capital Life Sciences and Rock Springs Capital, and received aggregate gross proceeds of approximately $11.3 million, before deducting placement agent fees and expenses payable by the company.

First Quarter 2024 Financial Results

● Cash Position: Cash and cash equivalents were $34.0 million as of March 31, 2024, compared to $44.7 million as of December 31, 2023. In addition, in April 2024, Xilio received approximately $44.6 million in gross proceeds related to the upfront payment under the license agreement with Gilead and the private placements with certain existing investors and Gilead.
● Research & Development (R&D) Expenses: R&D expenses were $10.4 million for the quarter ended March 31, 2024, compared to $16.1 million for the quarter ended March 31, 2023. The decrease was primarily driven by decreased spending related to early-stage research programs and indirect research and development, decreased manufacturing activities for XTX301, decreased personnel-related costs and a reduction of XTX101 costs due to a cost-sharing payment earned under the clinical trial collaboration with F. Hoffmann-La Roche Ltd. (Roche), partially offset by increases in clinical development activities for XTX101 and XTX202.
● General & Administrative (G&A) Expenses: G&A expenses were $6.1 million for the quarter ended March 31, 2024, compared to $7.4 million for the quarter ended March 31, 2023. The decrease was primarily driven by decreased personnel-related costs and professional and consulting fees.
● Net Loss: Net loss was $17.2 million for the quarter ended March 31, 2024, compared to $22.6 million for the quarter ended March 31, 2023.

Financial Guidance

Based on its current operating plans, Xilio anticipates that its existing cash and cash equivalents as of March 31, 2024, together with the $30.0 million upfront payment received in April 2024 under the license agreement with Gilead and approximately $14.6 million in aggregate gross proceeds received in April 2024 from private placements with certain existing investors and Gilead, will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2025.

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

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). In the third quarter of 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate XTX101 in combination with atezolizumab (Tecentriq) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety and tolerability of the combination in patients with advanced solid tumors in the Phase 1 dose escalation portion of the clinical trial. Subject to the results of Phase 1 combination dose escalation, Xilio plans to evaluate the safety and efficacy of the combination in the Phase 2 portion of the clinical trial in patients with microsatellite stable colorectal cancer. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

About XTX301 (IL-12) 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.

About XTX202 (IL-2) and the Phase 2 Clinical Trial

XTX202 is an investigational tumor-activated, beta-gamma biased IL-2 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. The Phase 2 clinical trial 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.

On May 14, 2024 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported the appointment of Michael Faerm as Chief Financial Officer, effective immediately (Press release, Viracta Therapeutics, MAY 14, 2024, View Source [SID1234643243]). Mr. Faerm is a seasoned biotech executive with more than 25 years of experience in life sciences companies, equity research and investment banking.

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"We are delighted to welcome Mike, an accomplished life sciences industry & Wall Street veteran, who we believe will be instrumental in supporting our next phase of development," said Mark Rothera, President and Chief Executive Officer of Viracta. "The encouraging clinical data generated to date underscores the potential of Nana-val’s innovative ‘Kick and Kill’ approach to effectively address the unmet treatment needs for patients with EBV-associated cancers. As we advance Nana-val through late-stage development and towards several pivotal milestones, we look forward to leveraging Mike’s strategic, operational and financial leadership."

Mr. Faerm added, "I am thrilled to join Viracta at this exciting time and relish the opportunity to make a meaningful impact on the company’s future. I look forward to working with the talented team at Viracta to progress the development of Nana-val and advance the company’s mission to bring innovative therapies to patients with virus-associated cancers."

Mr. Faerm most recently served as Interim Chief Financial Officer at Harpoon Therapeutics, Inc., which was acquired by Merck for approximately $680 million, and where he helped lead a $150 million PIPE financing. Prior to Harpoon, Mr. Faerm was the Chief Financial Officer of Artiva Biotherapeutics, Inc., where he led financial strategy and operations, and oversaw the company’s investor relations, financial planning, accounting and facilities functions. Previously, Mr. Faerm served as a consulting and interim Chief Financial Officer and Chief Business Officer for numerous biopharma companies. Prior to this, Mr. Faerm served as the Chief Business Officer of Innoviva, Inc. (formerly Theravance, Inc.), and earlier, worked in business development and strategic finance roles at Forest Laboratories and Regeneron Pharmaceuticals. Mr. Faerm’s Wall Street experience includes Credit Suisse and Wells Fargo Securities, where he was a senior equity research analyst covering the pharmaceutical sector, and Merrill Lynch, where he was an investment banker executing a wide range of strategic and capital markets transactions in biopharma and other healthcare sectors. Mr. Faerm earned his MBA from Harvard Business School, an M.S. in civil engineering from Stanford University, and a B.S. in civil engineering from Columbia University.

On May 14, 2024 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the first quarter of 2024 and provided a corporate update (Press release, Vincerx Pharma, MAY 14, 2024, View Source [SID1234643242]).

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"During the first quarter, we maintained momentum across our highly differentiated pipeline and our VersAptx platform," said Ahmed Hamdy, M.D., Chief Executive Officer. "Our recent financing provides capital to support the dose-escalation studies for our potentially best-in-class ADC, VIP943, and first-in-class SMDC, VIP236. We look forward to sharing an update on VIP236 by the end of Q3 and on VIP943 by the end of Q4. This timing will enable us to present more advanced dose-escalation data for both programs."

"We also continue to be excited by the clinical progress of enitociclib," continued Dr. Hamdy. "We have one patient with tFL who has achieved a metabolic PR and continues on enitociclib monotherapy therapy after 33 cycles. In addition, in the NIH study of enitociclib in combination with venetoclax and prednisone, two-thirds of patients have achieved a PR. We believe these clinical results show enitociclib is a best-in-class CDK9 inhibitor and has the potential to be a preferred partner for innovative combination therapies for hard-to-treat cancers."

FIRST QUARTER 2024 CLINICAL PROGRAM HIGHLIGHTS

VIP236

VIP236 is an αVβ3 SMDC conjugated to an optimized camptothecin (CPT) payload, created from Vincerx’s VersAptx platform. VIP236 is a first-in-class drug designed to deliver its optimized CPT payload directly to tumor tissues to overcome chemotherapy-related side effects. Preclinical studies have shown 11 times more optimized CPT is delivered to the cancerous tissues than found circulating in the blood. In addition, the optimized CPT is designed to limit drug transporter liabilities, a common mechanism for cancer resistance to chemotherapy.
At the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, Vincerx reported positive preliminary monotherapy data on VIP236 from a Phase 1 dose-escalation study demonstrating signs of clinical activity, including tumor reduction, and an improved safety profile in heavily pretreated patients with metastatic solid tumors.
As of March 25, 2024, the VIP236 open-label, multicenter, Phase 1 dose-escalation study (NTC05371054) had enrolled 20 patients with advanced or metastatic cancers unresponsive to standard therapies.
Vincerx looks forward to sharing additional Phase 1 data by the end of Q3 2024.
VIP943

VIP943, a novel CD123-targeted ADC created from Vincerx’s VersAptx platform, consists of an anti-CD123 antibody, a unique linker cleaved intracellularly by legumain, and a novel kinesin spindle protein inhibitor (KSPi) payload enhanced with Vincerx’s CellTrapper technology. Its next-generation effector chemistry was designed to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities.
Enrollment has begun in the fourth cohort of the Phase 1 dose-escalation study of VIP943 in relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) (NCT06034275). Preliminary pharmacokinetic (PK) results on the first two cohorts were presented at the 2024 AACR (Free AACR Whitepaper) Annual Meeting and as expected, showed very little payload circulating in the blood. In addition, no dose-limiting toxicities have occurred in the 11 patients who have received VIP943 so far. The preliminary PK and early observations of a favorable safety profile are consistent with VIP943 preclinical data.
Vincerx expects to present updated Phase 1 dose-escalation data for VIP943 by the end of Q4 2024.
Enitociclib

Enitociclib is a highly selective CDK9 inhibitor designed to block the activation of RNA polymerase II, leading to the reduction of oncogenes, including MYC and MCL1.
Enitociclib is currently in a Phase 1 dose-escalation study (NTC05371054) evaluating the combination of enitociclib, venetoclax and prednisone in diffuse large B-cell lymphoma (DLBCL) and PTCL. This study is being conducted in collaboration with the NIH.
In January 2024, Vincerx and the NIH reported two PRs in patients with PTCL with tumor reductions ranging from 86% to 91%. Additionally, one PR was reported in a patient with double-hit diffuse large B-cell lymphoma (DH-DLBCL) with an 80% reduction in tumor burden. Most recently, an additional PR was announced in PTCL with a reduction in lymph node size and skin lesions, totaling four PRs observed to date. Notably, these results were obtained with enitociclib doses below the anticipated efficacious levels. Currently, the study is enrolling patients for the third dose level (30 mg), which is the recommended dose established in the enitociclib monotherapy study.
These data will be presented by the NIH at the upcoming AACR (Free AACR Whitepaper) Advances in Malignant Lymphoma meeting in June 2024.
In a Phase 1 dose-escalation study (NCT02635672) of enitociclib as a monotherapy, one newly confirmed metabolic PR was observed with 63% tumor reduction in a tFL patient who has been enrolled in the study for just under two years. This is particularly notable because outcomes of patients with tFL are historically poor.
In total, this study enrolled 63 patients in the dose-escalation and expansion cohorts.
Enitociclib showed a favorable safety profile, dose-proportional pharmacokinetics, and on-target pharmacodynamic activity.
Significant clinical benefit across various indications includes two patients with DH-DLBCL who experienced durable complete metabolic remissions (3.7 and 2.3 years), which continued more than two years after stopping treatment.
This long duration of treatment and response for patients with DH-DLBCL and tFL highlight enitociclib’s favorable safety profile and monotherapy efficacy in hard-to-treat hematologic malignancies.
Additionally, 13 patients with solid tumors achieved stable disease as their best response to monotherapy treatment. Notably, of these, five were patients with ovarian cancer, providing a promising signal for future combination studies in this indication.
Research collaborations continue with the University of Calgary and the Pediatric Oncology Experimental Therapeutics Investigators’ Consortium (POETIC) to discover combination strategies for pediatric leukemia and central nervous system tumors. To date, these collaborations have shown that enitociclib has monotherapy and combination activity in preclinical models of rhabdomyosarcoma, neuroblastoma and KMT2A-rearranged pediatric leukemia.
VIP924

VIP924 is a first-in-class CXCR5-targeted ADC created from Vincerx’s VersAptx platform.
VIP924 can be evaluated in B-cell malignancies, including MCL, FL, DLBCL, and CLL and monotherapy and in combination.
IND application is anticipated in late 2025 or early 2026, pending funding.
VersAptx Platform

VersAptx is Vincerx’s versatile and adaptable, next-generation bioconjugation platform. The modular nature of this platform enables the combination of different targeting, linker and payload technologies to develop bespoke bioconjugates to address different cancer biologies.
At the AACR (Free AACR Whitepaper) Annual Meeting, Vincerx reported data from preclinical studies applying the next-generation effector chemistry of its VersAptx platform to TRODELVY and ENHERTU, two marketed ADCs, demonstrating the potential to improve tumor toxicity of ADCs by orders of magnitude, while improving on safety and tolerability. These findings further support the versatility of VersAptx to address multiple cancer types and increase the efficacy and safety of ADCs.
FIRST QUARTER 2024 FINANCIAL RESULTS

Vincerx had approximately $5.1 million in cash and cash equivalents as of March 31, 2024, which does not include the proceeds from our recent financing in April, as compared to approximately $12.8 million as of December 31, 2023. Based on its current business plans and assumptions, Vincerx believes its available capital, including the recent financing proceeds of approximately $17.8 million, will be sufficient to meet its operating requirements through the end of 2024.
Research and development expenses for the first quarter ended March 31, 2024 were approximately $4.6 million, as compared to approximately $10.9 million for the same period in 2023. This decrease is primarily the result of decreases in manufacturing services associated with our ADC programs of approximately $2.6 million, research services of approximately $2.6 million, and personnel-related expenses of approximately $1.1 million.
General and administrative expenses for the first quarter ended March 31, 2024 were approximately $2.9 million, as compared to approximately $4.5 million for the same period in 2023. This decrease is primarily driven by decreases in personnel-related expenses of approximately $0.6 million, professional services of $0.5 million and facilities and other corporate overhead expenses of $0.3 million.
For the first quarter ended March 31, 2024, Vincerx reported a net loss of approximately $12.4 million, or $0.58 per share. For the first quarter ended March 31, 2023, Vincerx reported a net loss of approximately $14.6 million, or $0.69 per share.

On May 14, 2024 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported financial results for the first quarter ended March 31, 2024 (Press release, Tracon Pharmaceuticals, MAY 14, 2024, View Source [SID1234643241]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"With ENVASARC fully enrolled we are focused on leveraging our Product Development Platform to generate non-dilutive capital through either an additional license or by replacing a CRO and executing clinical trials for partners at a lower cost compared to a CRO but still at a premium to our costs using a pay for performance model," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We look forward to reporting the final response assessment data in all patients from the ENVASARC Phase 2 pivotal trial, which are expected in the third quarter."

Recent Corporate Highlights

In April, we announced updated interim safety and efficacy data from the ENVASARC Phase 2 pivotal trial in 73 patients treated with single agent envafolimab. The objective response rate (ORR) was 11% by investigator review and 5.5% by blinded independent central review (BICR), all of which were confirmed responses. Envafolimab monotherapy was generally well tolerated and median duration of response by BICR was greater than six months. The primary endpoint of the study is achievement of an ORR by BICR in nine of 82 patients (11%) treated with envafolimab and median duration of response of greater than six months is a key secondary endpoint.
In April, the Company announced that the Nasdaq Hearings Panel granted the Company’s request for an extension to demonstrate compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price and $2.5 million stockholders’ equity requirements, through June 3, 2024, provided the Company execute a reverse stock split and file an S-1, both of which the Company executed in April. The Company continues to consider alternatives to address the $2.5 million stockholders’ equity requirement on or before June 3, 2024.
Expected Upcoming Milestone

Report the final response assessment data including duration of response in all patients from the ENVASARC Phase 2 pivotal trial, which are expected in the third quarter of 2024.
First Quarter 2024 Financial Results

Cash, cash equivalents and restricted cash were $8.0 million at March 31, 2024, compared to $8.6 million at December 31, 2023, which is expected to fund the Company late into the third quarter of 2024.
Research and development expenses for the first quarter of 2024 were $1.9 million, compared to $5.0 million for the first quarter of 2023. The decrease was primarily related to completing enrollment of the ENVASARC Phase 2 pivotal trial in 2024.
General and administrative expenses for the first quarter of 2024 were $1.4 million, compared to $2.3 million for the first quarter of 2023.
Net loss for the first quarter of 2024 was $3.2 million, compared to $8.5 million for the first quarter of 2023.
Conference Call Details

To access the call by phone, please register using this link and you will be provided with dial-in details.

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC Phase 2 pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON enrolled patients in ENVASARC with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. A total of 82 evaluable patients have received treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review in nine of 82 patients (11%) with duration of response a key secondary endpoint.

On May 14, 2024 Synlogic, Inc. (Nasdaq: SYBX), a biopharmaceutical company advancing novel therapeutics to transform the care of serious diseases, reported financial results for the first quarter 2024 and provided a corporate update (Press release, Synlogic, MAY 14, 2024, View Source [SID1234643239]).

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In March 2024, the Company retained Lucid Capital Markets, LLC to act as its financial advisor to explore and evaluate strategic options for maximizing shareholder value. Potential strategic alternatives that may be explored or evaluated as part of this process include the potential for an acquisition, merger, business combination or other strategic transaction involving the Company. The Board has not set a timetable for the conclusion of this review, nor has it made any decisions related to any further actions or potential strategic options at this time. There can be no assurance, however, that this process will result in any such transaction.

First Quarter 2024 Financial Results

As of March 31, 2024 Synlogic had cash, cash equivalents, and short-term marketable securities of $32.3 million.

Revenue was $0.01 million for the three months ended March 31, 2024, compared to $0.2 million for the corresponding period in 2023. Revenue for the three months ended March 31, 2024 was related to a material transfer agreement and revenue for the corresponding period in 2023 was associated with the prior research collaboration with Roche. Research and development expenses were $7.7 million for the three months ended March 31, 2024, compared to $12.5 million for the corresponding period in 2023. General and administrative expenses for the three months ended March 31, 2024 were $2.9 million compared to $4.0 million for the corresponding period in 2023. Restructuring and other charges were $28.2 million for the three months ended March 31, 2024, as a result of the Company’s decision in February 2024 to discontinue Synpheny-3, its pivotal study of labafenogene marselecobac (SYNB1934) in phenylketonuria (PKU) and evaluate strategic options for the Company.

For the three months ended March 31, 2024 Synlogic reported a consolidated net loss of $31.6 million, or $2.60 per share, compared to a consolidated net loss of $15.6 million, or $3.39 per share, for the corresponding period in 2023.