On August 8, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported operational highlights and financial results for the second quarter ended June 30, 2022 (Press release, Lantern Pharma, AUG 8, 2022, View Source/news/press-releases/detail/92/lantern-pharma-reports-second-quarter-2022-financial" target="_blank" title="View Source/news/press-releases/detail/92/lantern-pharma-reports-second-quarter-2022-financial" rel="nofollow">View Source [SID1234617772]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This quarter was marked with very exciting and important milestones for Lantern as we advance the majority of our drug candidates into and towards clinical trials. In mid-July, we received notice from the FDA that our Phase 2, Harmonic trial, for LP-300 was cleared to launch and we anticipate enrolling the first patients in the third quarter of this year. The Harmonic trial is focused on a unique population of lung cancer patients who are never smokers and have relapsed non-small cell lung cancer (NSCLC). Not only are never smokers with NSCLC unique, but they also represent a large population of patients with over 200,000 people diagnosed annually worldwide," stated Panna Sharma, President and CEO of Lantern Pharma.

"Lantern has also established a path to bring our drug candidates LP-184 and LP-284 into Phase 1 clinical trials in the first half of 2023. The structural similarities of these molecules have allowed us to develop synergies in manufacturing, chemical synthesis, and scale-up and we now believe we can bring both of these drug candidates to the clinic near-simultaneously. We are anticipating two Phase 1 clinical trials for LP-184, one in central nervous system (CNS) indications and one in genomically-defined solid tumors, and one Phase 1 clinical trial for LP-284 in non-Hodgkin’s B-cell lymphomas," continued Sharma.

"In addition to the exciting clinical developments, the RADR team has been focused on making substantial improvements to RADR’s infrastructure, automation capabilities, and algorithms. These advances will not only streamline RADR insights for Lantern, but will facilitate future commercial partnering opportunities."

Operational Highlights:

Lantern’s Portfolio:

LP-300 – In July, Lantern announced the launch of the Phase 2 clinical trial, Harmonic, for LP-300. Harmonic is a clinical trial for never smoker patients with relapsed NSCLC and will assess the effect of LP-300 in combination with standard of care (SOC) chemotherapy, pemetrexed and carboplatin, on patient overall and progression-free survival. The trial will begin enrolling patients this quarter across multiple sites in the US, and enrollment is anticipated to last from 12-16 months. The Company anticipates initial results from the trial will be available in Q4 2023.

The Company is also engaging in global partnering discussions for regions of the world where there is a higher prevalence of never smokers with NSCLC, including parts of Asia, South America, and Europe. Additional trial information on the Harmonic clinical trial can be found at the clinicaltrials.gov website and in the press release for the Harmonic trial launch.
LP-184 – Lantern anticipates completing the IND enabling studies and submitting an IND application for LP-184 to the U.S. Food and Drug Administration in Q1 2023. A Phase 1 clinical trial in genomically defined pancreatic, bladder cancers, and other solid tumors is anticipated for Q2 2023.

This quarter Lantern has also established a pathway towards a second Phase 1 trial for LP-184 in central nervous system (CNS) tumors in collaboration with Johns Hopkins University. Indications for this trial are anticipated to include gliomas and brain metastases, which collectively are diagnosed in over 100,000 patients in the US annually and are estimated to represent a $4 billion global market size. Conducting two Phase 1 trials will allow Lantern to maximize the potential of LP-184 for these two different cancer classes that have varying clinical needs and standards of care.

LP-284 – Lantern has accelerated the development of LP-284, aided by manufacturing process and synthesis similarities between LP-284 and LP-184. IND enabling animal studies for LP-284 have been initiated and are targeted to be completed by Q1 2023, with the IND filing for an LP-284 Phase 1 clinical trial anticipated for Q1 2023. Lantern is developing LP-284 for non-Hodgkin’s B-cell lymphomas (NHL), where LP-284 has shown nanomolar potency across multiple in vitro and in vivo studies and where there is a demonstrated clinical need. Early NHL indications for LP-284 may include: Mantle Cell Lymphoma (MCL), Double Hit Lymphoma (DHL), and other NHL cancer subtypes.

Based on new and ongoing preclinical studies as well as modeling driven by RADR, LP-284 has demonstrated nanomolar potency across a range of NHL cancers both as a stand-alone agent and in synergy with today’s standard of care drugs such as Ibrutinib and Bortezomib. Lantern will be presenting additional data from these studies later this year. Globally, MCL and DHL alone are estimated to impact over 45,000 patients each year, with virtually all patients relapsing 2-5 years after treatment. There is a significant clinical need for additional late stage therapeutic options for these patients.
LP-100 – is in a Phase 2 trial in Denmark for patients with metastatic castration resistant prostate cancer (mCRPC) that meet a certain genomic signature that correlates to enhanced sensitivity to LP-100. In the initial cohort of patients, nine patients experienced a median overall survival of 12.5 months. We are continuing to evaluate clinical development possibilities for LP-100 that we believe can further de-risk the program while increasing the potential for patient benefit that exceeds the current standards of care. At this time, our in silico, in vitro, and in vivo data indicate that co-administration of LP-100 in conjunction with PARP (Poly ADP-Ribose Polymerase) inhibitors can have a synergistic effect in cancer treatment and may represent an improvement over existing standards of care for prostate cancer patients with loss of HRR (homologous recombination repair) function.

About 20-25% of all patients with advanced prostate cancer present germline or tumor mutations in HRR-related genes, the most common being BRCA2, mutated in approximately 10-12% of all advanced prostate cancers – representing an estimated global opportunity approaching 2.5 billion USD annually in prostate cancer alone.
RADR Platform Growth and Development

RADR, Lantern’s A.I. and M.L. platform, surpassed 21 billion data points and is on pace to reach our year end goal of over 25 billion data points. This past quarter, RADR has undergone significant upgrades to its automation, data interfaces, infrastructure, and integration of a wider range of algorithms. The algorithms are additionally being automated to track performance and precision and also to leverage an ensemble approach to determine fit based on both biological and statistical measures. Further automation is expected to increase the performance of RADR by a factor of 2x to 4x in the coming months. These advances will increase the power and speed of generating insights from RADR for Lantern and its collaborators, as well as facilitate additional partnering opportunities.
In May 2021, Lantern entered a collaboration with Actuate Therapeutics, Inc. to leverage RADR to accelerate the identification and development of actionable clinical biomarkers for Actuate’s drug candidate, elraglusib (9-ING-41). Using advanced ML ensemble algorithms RADR-aided computational approaches have been successful in identifying candidate predictive biomarkers and modeling clinical response to elraglusib. These insights are being used to inform the development of elraglusib and the design of Phase II randomized clinical trials. These methods will be further applied to future biomarker validation and will be expanded to incorporate modeling with additional forms of patient data in the future, including RNA, ctDNA, soluble biomarkers, and others. Based our collaboration agreement with Actuate, Lantern will receive equity based on meeting development milestones and the application of computational models to elraglusib pharmacodynamics in future development.
Scientific Collaborations Updates

This May, Lantern hosted a key opinion leader webinar for Brain Tumor Awareness Month which focused on glioblastoma (GBM) and the potential of LP-184 for GBM and other brain cancers. The webinar featured two leading experts in GBM and brain cancer research from John Hopkins, John Laterra, M.D., Ph.D. and Matthias Holdhoff, M.D., Ph.D. A replay of the webcast can be found here.
During Childhood Cancer Awareness Month in September, Lantern will host a KOL webinar featuring Dr. Peter Houghton, Ph.D., a leading expert in childhood cancers at the Greehey Children’s Cancer Institute at the University of Texas San Antonio Health Science Center. The webinar will focus on challenges in drug development for pediatric cancers and preliminary results from Lantern’s drug candidates in preclinical pediatric cancer models. Details of the KOL webinar will be released in early September.
Upcoming Conferences

In the second half of 2022, Lantern will be presenting new preclinical data at several scientific conferences, including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) special conference for pancreatic cancer, the Society of Hematologic Oncology (SOHO) Tenth Annual Meeting, and several others. Results and conference details will be announced in the coming weeks.
Lantern Pharma’s President and CEO, Panna Sharma will be presenting at two investor conferences in the fall, the MicroCap Rodeo in Chicago, October 12-13th and at the ThinkEquity Conference in New York, October 26th, where he will also be leading a panel discussion on "How established and emerging biopharma companies are leveraging AI to transform drug development costs and timelines".
Additional Highlights

At Lantern’s annual meeting of stockholders held on June 8th, 2022, Dr. Maria Maccecchini, Ph.D. was elected to Lantern’s Board of Directors, along with 5 existing Directors.
Second Quarter 2022 Financial Overview

Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $62.2 million as of June 30, 2022, compared to approximately $79.6 million as of June 30, 2021. The quarterly cash burn continues to reflect our capital-efficient, collaborator-centered business model.
R&D Expenses: Research and development expenses were approximately $3.0 million for the quarter ended June 30, 2022 compared to approximately $1.2 million for the quarter ended June 30, 2021.
G&A Expenses: General and administrative expenses were approximately $1.4 million for the quarter ended June 30, 2022, compared to approximately $1.3 million for the quarter ended June 30, 2021.
Net Loss: Net loss was approximately $4.5 million (or $0.41 per share) for the quarter ended June 30, 2022, compared to a net loss of approximately $2.3 million (or $0.21 per share) for the quarter ended June 30, 2021.
Earnings Call and Webinar Details

Lantern will host its second quarter fiscal year 2022 earnings call and webinar today, Monday, August 8th, 2022 at 4:30 p.m. ET.

View Source
Related presentation materials will be accessible at: View Source
Replay Details

A replay of the Q2 2022 earnings call and webinar will be available at View Source.