On August 8, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, reported operational highlights and financial results for the second quarter 2024, ending June 30, 2024 (Press release, Lantern Pharma, AUG 8, 2024, View Source [SID1234645612]).

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"The team at Lantern Pharma is making solid, thoughtful and disciplined progress in our clinical trials and in our collaborative research and AI efforts. This past quarter saw a significant milestone where our clinical trials are getting to the point of having initial patient data that we can share, including our unique Harmonic clinical trial for never smokers with lung cancer. We continue to also improve the functionality and abilities of our AI platform, RADR, to guide the next phase of our therapeutic programs which will be heavily marked by trials with combination regimens, and ADC development." said Panna Sharma, President and CEO of Lantern Pharma.

Highlights of AI-Powered Pipeline:

Ø LP-300: The Harmonic Phase 2 Clinical Trial – Preliminary results at the completion of the 7-patient lead-in part of the Harmonic study demonstrated predictable safety profiles that are consistent with the chemotherapy regimen alone and seemed to demonstrate clinical benefit for 6 out of the 7 patients – an 86% clinical benefit rate (CBR). No patients experienced dose limiting toxicities, and no discontinuations were observed due to treatment related toxicity. Six patients experienced clinical benefit from the combination of LP-300 and chemotherapy while 1 patient experienced progressive disease. The clinical benefit rate is 86% for this group with an objective response rate (ORR) of 43%. Of the 6 patients experiencing clinical benefit – 3 patients showed partial responses with an average tumor size reduction of 51% and 3 patients have stable disease with an average tumor size reduction of 13%. Encouraging preliminary efficacy results were observed regardless of prior tyrosine kinase inhibitor (TKI) treatment(s), demographics, and metastatic disease sites. In the initial set of patients, those having low to intermediate TMB (tumor mutation burden) were found to be responsive to LP-300 + chemotherapy.

The phase 2 Harmonic clinical trial sites in the US, and certain sites in Japan are screening for eligible patients and we expect the pace of enrollment to increase in the coming months. This past quarter we also initiated IRB approvals and site initiation visits in Asia. The expansion of the Phase 2 clinical trial in Japan and Taiwan is expected to accelerate the collection of patient and response data that are needed for the next-stage of development of LP-300, a therapeutic for the treatment of relapsed and inoperable primary adenocarcinoma of the lung given in combination with chemotherapy. Additionally, it may also bring a needed therapeutic option for never-smokers with NSCLC in Japan and Taiwan, where one-third or more of all lung cancer diagnoses are made among those who have never smoked. Dr. Yashushi Goto, a physician and researcher focused on lung cancer at the National Cancer Center of Japan, will be leading the phase 2 trial in Japan, where the incidence of non-small cell lung cancer (NSCLC) in never-smokers is double or more than that of the United States. Lantern believes that this improves the positioning for drug-candidate LP-300 to develop collaborative and co-development partnerships with global biopharma companies with a primary focus in serving the Asian markets.

The Harmonic trial is assessing the effect of LP-300 in combination with standard-of-care chemotherapy in never-smoker patients with relapsed NSCLC where they have failed TKI therapies. Globally, never-smokers with NSCLC are a growing population of patients and do not respond well to PD-1/PD-L1-based therapies or the available chemotherapy doublets, leaving them with reduced treatment options. In the US it is estimated that the treatment indication of never smokers with NSCLC has an annual market potential of $1.5 billion, and a global estimated annual market potential of over $2.6 billion.

Ø LP-184 – Seven cohorts of patients have been enrolled and dosed – in escalating doses – in the ongoing Phase 1A clinical trial – a first-in-human Phase 1 basket trial across multiple solid tumor indications that are advanced and refractory to existing standard-of-care therapies. We expect to reach a dosage level in the coming cohort where therapeutic concentrations of the drug should be attainable based on our pharmacokinetic and pharmacodynamic analyses. The trial is actively enrolling patients across multiple US centers that have relapsed/refractory advanced solid tumors, such as pancreatic cancer, glioblastoma (GBM), lung, triple-negative breast cancer, and multiple other solid tumor types with DNA damage response deficiencies. No dose-limiting toxicities have been observed to date in the LP-184 trial, and the Company believes that enrollment should be complete this year and on-track for an initial readout of safety and molecular correlation data by the close of the year. The dosage and safety data obtained in the Phase 1A trial are expected to be used to advance the central nervous system (CNS) indications for a future Phase 1b/2 trial to be sponsored by Lantern’s wholly owned subsidiary, Starlight Therapeutics, as well as other later phase trials in select tumors that have shown superior responsiveness to LP-184 and meet with genomically guided criteria related to drug-response. Lantern has also made advancements toward a key milestone related to the development of a quantitative PCR-based molecular diagnostic test that may help in identifying patients with the best likelihood of response and benefit from treatment with LP-184.

AI and preclinical studies are also ongoing to further refine drug combination studies supporting the use of LP-184 to improve the durability or overall response rates in combination with FDA approved drugs that are widely used in cancer treatment – especially PARP inhibitors, and immune checkpoint inhibitors. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $12+ billion, consisting of $4.5+ billion for CNS cancers and $7.5+ billion for solid tumors.

Ø LP-284 – The third cohort of patients are being dosed, and no dose-limiting toxicities have been observed in the LP-284 Phase 1A clinical trial. We expect to open additional sites in the US throughout the third quarter with the potential to advance to Phase 1B and 2 by the close of 2024 or early 2025. LP-284 has shown nanomolar potency across multiple published in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit lymphoma (DHL), and other advanced NHL cancer subtypes with DNA damage response deficiencies, notably those with compromised functioning of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions. Nearly all MCL, DHL, and HGBL patients relapse from the current standard-of-care agents and there is an urgent and unmet need for novel improved therapeutic options for these patients. In the US and Europe, MCL, DHL, and HGBLs are diagnosed in 16,000-20,000 patients each year and have an estimated annual market potential of over $3+ billion.

We have also begun a review of some notable mechanisms-of-action of LP-284 that may be leveraged in other diseases and conditions. Lantern expects to review those preclinical studies and findings later this quarter.

RADR Platform Growth and Development:

Ø RADR continues to advance in size, scope, and capabilities and is also progressing towards becoming recognized as a standard for AI-driven drug development in oncology – for both early-stage development and later-stage patient biomarker and combination therapy identification. Lantern will potentially focus additional data growth efforts of the RADR platform on: drug sensitivity data, combination treatment outcome data, and biomarker data in rare cancers, and on emerging synthetic lethal targets that are aimed at accelerating the development of new therapies for Lantern and its partners. The scope of RADR’s data has broadened with a strategic focus on additional classes of compounds, detailed data on chemical and biochemical features and drug-interaction data. Real-world data from clinical studies such as those being obtained from liquid biopsy, and data from preclinical combination studies that aim to define drug interaction and optimal dosage are being incorporated into the datapoints and data sets powering RADR.

Lantern also leveraged the RADR platform in developing a drug-development collaboration with Oregon Therapeutics with a focus on accelerating the development and decision path towards a first-in-human launch of the drug-candidate, XCE853 into the clinic. The AI-enabled collaboration with Oregon Therapeutics aims to refine and expand the positioning of XCE853, a novel protein disulfide isomerase (PDI) inhibitor, in new and targeted oncology indications, including for drug-resistant tumors. Lantern Pharma is receiving equal IP co-ownership and drug development rights in newly discovered biomarkers, novel indications, and use for new pharmacological strategies for XCE853.

Additionally, the RADR platform’s generative AI capabilities, focusing on molecular optimization and automated feature extraction to improve understanding and prediction of molecular dynamics, safety, and drug-drug interactions are planned to increase in functionality and scope in the coming quarters for both small molecule development and increasingly for ADC development, analytics and characterization.

Second Quarter 2024 Financial Highlights

Ø Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $33.3 million as of June 30, 2024, compared to approximately $41.3 million as of December 31, 2023. The quarterly cash burn rate continues to reflect our capital-efficient, collaborator-centered business model.

Ø R&D Expenses: Research and development expenses were approximately $3.9 million for the quarter ended June 30, 2024, compared to approximately $3.6 million for the quarter ended June 30, 2023.

Ø G&A Expenses: General and administrative expenses were approximately $1.5 million for the quarter ended June 30, 2024, compared to approximately $1.6 million for the quarter ended June 30, 2023.

Ø Net Loss: Net loss was approximately $4.96 million (or $0.46 per share) for the quarter ended June 30, 2024, compared to a net loss of approximately $4.75 million (or $0.44 per share) for the quarter ended June 30, 2023.

Ø Total Share and Warrant Count: There were no warrant exercises during the three months ended June 30, 2024. Following June 30, 2024, additional warrants were exercised which increased the Company’s total shares outstanding and reduced the number of outstanding warrants. As of the date of this press release, the Company has 10,764,725 shares of common stock outstanding, and outstanding warrants to purchase 70,000 shares of common stock.

Additional Operational Highlights:

Ø A publication was made in the AACR (Free AACR Whitepaper) Journals, Cancer Research Communications showcasing the potential for LP-184 to synergize with PARP inhibitors in a wide range of solid tumors that are HRD (homologous repair deficient). The preclinical findings in the paper illustrate the potential of LP-184 to be a pan-HRD cancer therapeutic – which could be the first drug of this type in this class. We believe the data and results support clinical evaluation of LP-184 in a large subset of HRD solid tumors.

Ø New data and scientific findings conducted in conjunction with Drs. Yong Du and Shiaw-Yih (Phoebus) Lin at MD Anderson were presented at The Immuno-Oncology Summit 2024. The findings showcased what Lantern believes to be the role of LP-184 to be combined with checkpoint inhibitors to provide greater response in TNBC due to synergy and to potentially transform TNBC tumors that are unresponsive (cold) to checkpoint inhibitors to responsive (hot). The poster was titled: LP-184, a Novel Acylfulvene, Sensitizes Immuno-Refractory Triple Negative Breast Cancers (TNBCs) To Anti-PD1 Therapy by Affecting the Tumor Microenvironment.

Ø With a focus on increasing visibility and awareness of the Lantern portfolio and capabilities, the Company launched Webinar Wednesdays in April. They are currently planned to be held on the last Wednesday of each month and are designed to showcase industry leaders in AI and drug development, as well as clinicians working in collaboration with Lantern’s portfolio of drug-candidates. The next three Webinar Wednesdays will include the topics of: 1) LP-300’s clinical results to-date, 2) RADR and our industry-leading ability to predict if a molecule or drug-compound will cross the BBB (Blood-Brain-Barrier), and 3) The role of LP-184 in synergizing with checkpoint inhibitors and IO agents.

Earnings Call and Webinar Details:

Lantern will host its 2nd quarter 2024 earnings call and webinar today, August 8th, 2024, at 4:30 p.m. ET. A link to register can be accessed at: Lantern 2nd Quarter 2024 Earnings Call & Webinar Link

Ø Related presentation materials will be accessible at: View Source
Ø A replay of the 2nd quarter 2024 earnings call and webinar will be available at: View Source

On August 8, 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 second quarter of 2024 and provided an overview of its clinical programs and anticipated milestones (Press release, Vincerx Pharma, AUG 8, 2024, View Source [SID1234645628]).

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"During the second quarter, our team focused on execution and the continued enrollment of patients in our ongoing Phase 1 studies for our potentially best-in-class ADC, VIP943, and first-in-class SMDC, VIP236," said Ahmed Hamdy, M.D., Chief Executive Officer. "We look forward to evaluating the results from additional cohorts and sharing data by end of Q3 for VIP236 and by end of year for VIP943."

SECOND QUARTER 2024 CLINICAL PROGRAM HIGHLIGHTS AND ANTICIPATED MILESTONES

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.
Vincerx expects to share additional Phase 1 study data for VIP943 for patients with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) (NCT06034275) by the end of Q4 2024.
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.
Vincerx looks forward to sharing additional data from this Phase 1 study (NTC05371054) by the end of Q3 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 peripheral T-cell lymphoma (PTCL). This study is being conducted in collaboration with the National Institutes of Health (NIH).
At the AACR (Free AACR Whitepaper) Advances in Malignant Lymphoma meeting in June 2024, the NIH presented the interim study results previously shared by Vincerx in January 2024 and May 2024.
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 mantle cell lymphoma, follicular lymphoma, DLBCL, and chronic lymphocytic leukemia , as a monotherapy and in combination.
IND application is anticipated in 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.
SECOND QUARTER 2024 FINANCIAL RESULTS

Vincerx had approximately $16.3 million in cash, cash equivalents and marketable securities as of June 30, 2024, as compared to approximately $5.1 million as of March 31, 2024. Based on its current business plans and assumptions, Vincerx believes its available capital, including the proceeds of its April financing of approximately $16.9 million, will be sufficient to meet its operating requirements through the end of 2024.
Research and development expenses for the second quarter ended June 30, 2024 were approximately $3.8 million, as compared to approximately $8.2 million for the same period in 2023. This decrease is primarily the result of decreases in research services of approximately $1.8 million, manufacturing services associated with our ADC program of approximately $1.6 million, and personnel related expenses of approximately $0.8 million.
General and administrative expenses for the second quarter ended June 30, 2024 were approximately $3.6 million, as compared to approximately $3.8 million for the same period in 2023. This decrease is primarily driven by decreases in personnel-related expenses of approximately $0.3 million.
For the second quarter ended June 30, 2024, Vincerx reported a net loss of approximately $1.8 million, or $0.05 per share. For the second quarter ended June 30, 2023, Vincerx reported a net loss of approximately $11.6 million, or $0.54 per share.

On August 8, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an update on the Company’s clinical progress and plans for expansion (Press release, Bio-Path Holdings, AUG 8, 2024, View Source [SID1234645558]).

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"The Bio-Path team continues to work diligently toward advancing our important clinical work and have made meaningful progress in a number of areas critical to each program’s success," said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. "With the increased clinical data that we have generated, we are now able to develop the biomarkers needed to incorporate into our oncology studies. In addition, we have completed preparations for preclinical work to support advancing prexigebersen as a potential treatment for obesity. In tandem, we are designing development plans for first-in-human clinical studies in this expansive global market for weight loss."

"The incremental advances that we are making across these programs collectively push our DNAbilize platform closer to delivering these medicines to patients. Moreover, we are continuing to see the broader potential of our platform beyond oncology and look forward to realizing its potential across multiple indications, starting with obesity," continued Mr. Nielsen. Clinical Program Overview Bio-Path’s clinical development program consists of one Phase 2 clinical trial and three Phase 1 or 1/1b clinical trials.

Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment and is currently expanding prexigebersen preclinical studies for the treatment of obesity. Development of Molecular Biomarkers – Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment, the goal of which is to identify patients with a genetic profile more likely to respond to treatment, thereby improving the probability of success for this program. The emerging role of biomarkers has enhanced cancer development over the past decade and has become a more common companion to many oncology programs.

Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients. This trial is comprised of three separate cohorts of patients and treatments, each separately approvable by the FDA as a new drug indication. The first two cohorts are treating patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes untreated AML patients, and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort is treating relapsed/refractory AML patients, who are venetoclax-resistant or intolerant, with the two-drug combination of prexigebersen and decitabine. Based on recent interim data for safety and efficacy, the Company plans to pursue next development steps by applying molecular biomarkers to future patient selection for enrollment into the Phase 2 clinical trial. Outcomes for these older patients who are unable to receive intensive chemotherapy due to the challenging side effect profile remain suboptimal with a median survival of only five to ten months. The study is currently paused for an interim analysis, amendment preparation and U.S. Food and Drug Administration (FDA) review. Bio-Path expects to complete enrollment in cohorts 1 and 2 of the study over the next eighteen months. Phase 1/1b Clinical Trial in BP1001-A in

Advanced Solid Tumors – A Phase 1/1b clinical trial of BP1001-A in patients with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer, is ongoing. BP1001-A is a modified product candidate that incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. The Phase 1 study has advanced to the second, higher dose level. The Phase 1b portion of the study is expected to commence after successful completion of the three

BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late stage pancreatic cancer. In recent months, Bio-Path advanced to dose level 2 and expects to complete enrollment in order to advance to dose level 3 by year-end.

Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. The drug venetoclax treats AML patients by blocking the activity of the Bcl-2 protein in AML patients. However, patients become resistant to venetoclax. BP1002 treats the Bcl2 target by blocking the cell’s ability to produce Bcl-2, and could have the potential to eliminate the need for venetoclax.

AML patients that fail frontline venetoclax-based therapy have very poor prognosis with median overall survival of less than three months. The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities. Bio-Path recently completed the second dose cohort of 40 mg/m2 and is completing an analysis of PK/PD data to be submitted to the FDA in order to advance to the next dose level. Upon submission of data and approval from FDA, Bio-Path expects to advance to dose level 3 in the fourth quarter of 2024.

Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL) – A Phase 1 clinical trial to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients is currently ongoing. The Phase 1 clinical trial is being conducted at the Georgia Cancer Center, The University of Texas Southwestern and New York Medical College. In January 2024, Bio-Path announced successful completion of the first dose cohort in the Phase 1 clinical trial. A total of six evaluable patients are scheduled to be treated over two dose levels with BP1002 monotherapy in a standard 3+3 design, unless there is a dose limiting toxicity which would require an additional three patients to be tested. There were no dose limiting toxicities in the first dose cohort (20 mg/m2). Enrollment has continued for patients in the second BP1002 dose cohort of 40 mg/m2 and the Company expects to complete enrollment and to review these data by year-end.

Preclinical Work for BP1003 – The Company continues to advance its drug candidate, BP1003, for the treatment of advanced solid tumors, including pancreatic cancer. BP1003 is an antisense RNAi nanoparticle targeting the STAT3 protein. Plans are to conduct a Phase 1 study of BP1003 in patients with refractory, metastatic solid tumors (pancreatic, non-small cell lung cancer). Prexigebersen as Potential Treatment for Obesity and Obesity-related Cancers – The RNAi target of prexigebersen is the Grb2 protein, which is involved in activating the RAS/ERK pathway for cell growth. By blocking the cell’s ability to produce Grb2, prexigebersen treatment may limit cell growth. In obesity, two such pathways are related to leptin and insulin. Activation of leptin or insulin receptors can stimulate the RAS/ERK pathway via Grb2i.

Bio-Path believes development of prexigebersen for the treatment for obesity and obesity-related cancers could be accelerated given the large amount of safety data from prexigebersen treatment of leukemia patients and the continued unmet medical need. The Company is preparing for preclinical development evaluating prexigebersen for the treatment of obesity and will continue thereafter to conduct additional Investigational New Drug (IND)-enabling studies with an aim to advance prexigebersen into first-in-human studies in this indication.

On August 8, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported the presentation of one-year clinical efficacy Phase 2 data for its lead compound EVX-01 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, taking place in Barcelona, Spain, from September 13-17, 2024 (Press release, Evaxion Biotech, AUG 8, 2024, View Source [SID1234645596]). The EVX-01 vaccine is a personalized therapy currently being assessed in patient with advanced melanoma (skin cancer).

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Christian Kanstrup, CEO of Evaxion, comments: "Having our abstract selected for presentation by the ESMO (Free ESMO Whitepaper) Congress 2024 Scientific Committee is a testament to the significant progress and impact of our work in the field of medical oncology. This is one of the most prestigious medical oncology conferences in the world and, as such, a great opportunity for us to make the data available to a large global audience of experts, researchers and collaborators, as well as potential partners. Presenting one-year Phase 2 clinical efficacy data for our lead pipeline candidate is a major milestone for Evaxion and advancing our own high-value programs to key value inflection points is an important part of our strategy."

Evaxion’s innovative approach to develop personalized cancer vaccines builds on its AI-Immunology platform. The vaccines are designed to target the unique genetic makeup of an individual’s tumor and are tailored to the patients’ immune system, potentially enhancing the efficacy of treatment and improving patient outcomes.

Presentation Details:

Abstract Title: Phase 2 study of AI-designed personalized neoantigen cancer vaccine, EVX-01, in combination with pembrolizumab in advanced melanoma
Abstract#: 1084P
Poster#: 2904
Track: Melonama and other skin tumours
Location: Hall 6
Date/Time: September 14 at 12.00 – 13.00 CEST
Presenter: Dr. Paola Queirolo, Director, Medical Oncology of Melanoma, Sarcoma and Rare Tumors, European Institue of Oncology, Milan, Italy
About EVX-01 Phase 2 Clinical Trial

EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC that, together with leading principal investigators and research centers from Italy and Australia, aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 therapy KEYTRUDA (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.

On August 8, 2024 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported its second quarter 2024 financial and operating results (Press release, Lineage Cell Therapeutics, AUG 8, 2024, View Source [SID1234645613]). The Company will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and to provide a business update.

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"The second quarter was highlighted by clinical and preclinical execution alongside expanded awareness and data updates on our lead program," stated Brian M. Culley, Lineage CEO. "As the cell transplant field expands and continues to deliver exciting clinical outcomes, we are excited about our validating partnership and the collective expertise of the team at Roche and Genentech, as well as their ongoing leadership of the OpRegen program through presentations at scientific conferences and internal thought leader events, including Roche’s Virtual Ophthalmology Day, hosted just last month. We continue to support the ongoing Phase 2a clinical study and also have initiated activities under the recently established services agreement with Genentech, enabling our partners to take advantage of our cell transplant expertise to more fully investigate the potential of the OpRegen program. In parallel, we are focused on activities in support of returning our second cell transplant program, OPC1, into the clinic this year for the treatment of spinal cord injury, a condition with growing awareness of its unmet need and commercial opportunity."

"Importantly, our continued inclusion within the Russell 3000 Index, can help our efforts to broaden investor awareness of, and support for, Lineage as a uniquely positioned cell transplant company, one with a pharma-validated lead program and a platform technology of internally-owned clinical and preclinical assets, which is focused on growing our internally-owned cGMP capabilities in support of process and intellectual property development," added Mr. Culley.

Recent Operational Highlights

RG6501 (OpRegen)
Continued execution under our collaboration with Roche and Genentech, a member of the Roche Group, across multiple functional areas, including support for the ongoing Phase 2a clinical study in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Initiated activities under recently established services agreement with Genentech to support ongoing development of OpRegen. Lineage is providing additional clinical, technical, training and manufacturing services, fully funded by Genentech, that further support the ongoing advancement and optimization of the OpRegen program and include: (i) activities to support the ongoing Phase 1/2a study and currently-enrolling Phase 2a study; and (ii) additional technical training and materials related to Lineage’s cell therapy technology platform to support commercial manufacturing strategies.
Positive clinical data from long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen presented by David Telander, MD, PhD, Retinal Consultants Medical Group, at the 2024 Retinal Cell & Gene Therapy Innovation Summit.
Mean best corrected visual acuity (BCVA) gain of 5.5 letters at 24 months (n=10) in Cohort 4 patients (less advanced GA)
Mean BCVA gains greater among patients with improvement in outer retinal structure (n=5, +7.4 letters)
Maintenance or increases in external limiting membrane (ELM) and retinal pigment epithelium (RPE) layer area at 24 months observed in patients with extensive coverage of OpRegen across the areas of GA (n=5)
Data suggest OpRegen may counteract RPE cell dysfunction and cell loss in patients with GA by providing support to remaining retinal cells, with multi-year effects observed following a single administration
Preclinical results from a surgical development study of OpRegen presented by Rachel N. Andrews, DVM, PhD, DACVP, Genentech, a member of the Roche Group, at 2024 Association for Research in Vision and Ophthalmology Annual Meeting (2024 ARVO).
OPC1
DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study for the treatment of subacute and chronic spinal cord patient start-up activities continue.
Hosted the 2nd Annual Spinal Cord Injury Investor Symposium, in partnership with the Christopher & Dana Reeve Foundation.
Balance Sheet Highlights

Cash, cash equivalents, and marketable securities of $38.5 million as of June 30, 2024 is expected to support planned operations into Q4 2025.

Second Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from collaboration revenues and royalties. Total revenues for the three months ended June 30, 2024 were $1.4 million, a net decrease of $1.8 million as compared to approximately $3.2 million for the same period in 2023. The decrease was primarily driven by less collaboration and licensing revenue recognized from deferred revenues under the collaboration and license agreement with Roche.

Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses for the three months ended June 30, 2024 were $7.3 million, a decrease of $0.9 million as compared to $8.2 million for the same period in 2023.

R&D Expenses: R&D expenses for the three months ended June 30, 2024 were $2.9 million, a net decrease of $1.0 million as compared to $3.9 million for the same period in 2023. The net decrease was primarily driven by $0.6 million for our OPC1 program and $0.3 million for our preclinical programs.

G&A Expenses: G&A expenses for the three months ended June 30, 2024 were approximately $4.3 million, a net increase of approximately $0.1 million as compared to $4.2 million for the same period in 2023. The increase was primarily driven by stock-based compensation expense and personnel costs.

Loss from Operations: Loss from operations for the three months ended June 30, 2024 were $5.9 million, an increase of $0.9 million as compared to $5.0 million for the same period in 2023.

Other Income/(Expenses): Other income (expenses) for the three months ended June 30, 2024 reflected other income of $0.1 million, compared to other expenses of ($0.2) million for the same period in 2023. The change was primarily driven by exchange rate fluctuations related to Lineage’s international subsidiaries, fair market value changes in marketable equity securities, and interest income earned within our money market accounts.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended June 30, 2024 was $5.8 million, or $0.03 per share (basic and diluted), compared to a net loss attributable to Lineage of $5.2 million, or $0.03 per share (basic and diluted), for the same period in 2023.

Conference Call and Webcast

Interested parties may access the conference call on August 8th, 2024, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call." A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 15th, 2024, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6024260.