On October 29, 2020 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary artificial intelligence ("A.I.") platform, RADR , to transform oncology drug discovery and development, reported financial results for the third quarter ended September 30, 2020 (Press release, Lantern Pharma, OCT 29, 2020, View Source [SID1234569358]).

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Panna Sharma, CEO and President of Lantern Pharma, stated, "We have been extremely focused on advancing our portfolio of compounds, increasing the functionality, capabilities and data powering our A.I. platform, while also strengthening our team with cancer biologists, data scientists and drug development professionals who share our passion to transform oncology drug development."

Lantern has three drug compounds in development where genomics and data-driven methods have been used to refine and accelerate the development process: LP-100 in a Phase 2 trial for the treatment of metastatic, hormone-refractory prostate cancer (MHRPC), which is partnered with a European biotech; LP-300 which is preparing to enter into a Phase 2 trial for non-small cell lung cancer (NSCLC) as a combination therapy; and LP-184 which is in preclinical development for genomically defined cancers, including prostate, pancreatic and glioblastoma multiforme (GBM).

Mr. Sharma also commented, "Our proprietary RADR platform recently surpassed one billion data points – which is roughly four times the amount of data since our June IPO. The data is comprised largely of genomic, transcriptomic and drug sensitivity datapoints that have been thoughtfully curated from both our own studies and from relevant published studies and cancer data sets. RADR was essential in helping determine that GBM, a particularly deadly form of brain cancer, should be a key focus in our portfolio development. Additionally, RADR has significantly accelerated the process of developing an initial signature that could be used to identify GBM patients, potentially resulting in a new more effective treatment and in uncovering sub-types of GBM in which our compound can be most effective. Our growing A.I. platform will be pivotal in uncovering potential new therapeutic opportunities and also in developing insights into the creation of combination-therapy programs."

During the third quarter, Lantern also announced drug development and research collaborations with two leading academic and translational research cancer centers, Fox Chase Cancer Center in Philadelphia and Georgetown University in Washington D.C. These collaborations are focused on advancing LP-184 in specific, genomically defined sub-types of pancreatic and prostate cancer. The focus of both collaborations is to provide critical insights for the design of our upcoming clinical testing for LP-184. The data and results from these collaborative studies will provide data that will advance the development of biomarker signatures and aid in defining the patient groups most likely to benefit from our therapies.

Corporate and Scientific Highlights

●RADR surpassed one billion curated data points which will help further enhance our ability to better understand the mechanisms of action behind drugs and drug classes being used as anti-cancer agents and help determine signatures that correlate to drug response. The milestone was reached ahead of schedule and enables new capabilities such as the ability to identify and suggest combination therapy programs and the ability to compare and contrast signatures generated by a variety of machine learning algorithms.

●The Company launched the next phase of a collaboration with Georgetown University for LP-184, a next-generation, targeted DNA-damaging agent. The first stage of the joint research activities began in the fourth quarter of 2019 and generated compelling evidence of activity of LP-184 in solid tumors that overexpress PTGR1. LP-184 anti-tumor activity can be linked to the over-expression of PTGR1 and will be further validated in the ongoing collaboration in specific sub-types of prostate cancer. The research is also expected to help guide the development of a signature that correlates to increased response among certain sub-types of metastatic and metastatic, hormone-refractory prostate cancer.

●The Company initiated a collaboration and research agreement with Fox Chase Cancer Center for the further development of Lantern’s LP-184 in pancreatic cancer. This collaboration advances the targeted use of LP-184 in genetically defined sub-types of pancreatic cancer with the development of biologically relevant and robust gene signatures to be used in upcoming clinical testing. If successful, LP-184 could provide, in the future, pancreatic cancer patients a personalized therapy option that has the potential to improve survival.

●LP-300 development was advanced in preparation for a Phase 2 clinical trial in non-small cell lung cancer (NSCLC) among never-smokers during 2021. The Company entered into discussions with key opinion leaders in NSCLC to refine the patient selection and treatment regimen decision criteria that are expected to guide discussions with the FDA. In addition, the Company began selection of clinical trial sites and potential investigators for the ongoing development of LP-300 as a potential first-in-class combination therapy for never smoking (or non-smoking) NSCLC patients with histologically defined adenocarcinoma. Lantern also established a manufacturing network and process for GMP production in preparation for its Phase 2 clinical trial of LP-300.

●The Company conducted in vitro validation studies demonstrating the ability of LP-184 to penetrate the Blood Brain Barrier (BBB) while preserving neuronal cell viability. A critical property of any drug for GBM is its ability to penetrate the blood brain barrier without causing damage to the nerve cells and tissue. These studies validated the in-silico generated results (from Q1, 2020) that demonstrated that LP-184 would have a BBB permeability equivalent to temozolomide and other drugs being used for GBM patients. LP-184 demonstrated significant permeability to BBB, in-line with existing standard of care agents and in the expected range of nanomolar potency. The Company will be providing additional details on this data, the biomarker signature, and the IND-enabling studies involved in the clinical trial process during Q4 2020.

Third Quarter Financial Highlights

●Cash Position: Cash and cash equivalents were $20.8 million as of September 30, 2020, compared to $1.2 million as of December 31, 2019. The increase was primarily due to proceeds from the IPO in June 2020.

●R&D Expenses: Research and development expenses were $600,769 for the quarter ended September 30, 2020, compared to $228,401 for the quarter ended September 30, 2019. The increase was primarily attributable to increases in drug candidate research studies and manufacturing related expenses and expansion of the Company’s research team.

●G&A Expenses: General and administrative expenses were $1,100,719 for the quarter ended September 30, 2020, compared to $441,251 for the quarter ended September 30, 2019. This increase was primarily due to an increase in expenses associated with transitioning to and becoming a public company.

●Net Loss: Net losses were $1,701,488 for the quarter ended September 30, 2020, or $0.27 per share, compared to a net loss of $669,652 for the quarter ended September 30, 2019.

Mr. Sharma continued, "We are changing the pace, risk and cost of oncology drug discovery and development. The high failure rate and protracted development process lead to development costs in oncology that are not sustainable for our health-care system or for patients globally. A.I. and large scale machine-learning enabled systems that can leverage real-world oncology data and biomarker driven approaches offer the tremendous potential of a more sustainable route and one that can lead in the transformation of oncology drug development to benefit patients and advance medicine."

Conference Call

Lantern Pharma will host a conference call and webcast today, Thursday, October 29 at 4:00 p.m. ET.

Conference Call & Webcast Details

●Toll-free Domestic & Canada: 866.342.8588 – conference ID 55977

●International: 203-518-9865 – conference ID 55977

●US and Canada callers one touch dial: +1.866.342.8588,,55977#

●Live (audio-only) webcast and related presentation materials will be accessible via a weblink at View Source

Web participants should register 15 minutes prior to the start of the call. The webcast will be archived on the Lantern Pharma website for 30 days.

Replay Details

A replay of the conference call will be available for replay until 11:59 pm ET November 29, 2020.

●Replay Number: 1-800-925-9932 – passcode 55977.