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<_span_style3d_22_text-decoration3a_ _underline3b_22_="">First Quarter 2021 Financial and Operational Results</_span_style3d_22_text-decoration3a_>
On May 3, 2021, Lantern Pharma, Inc. LTRN announced first quarter 2021 financial and operational results, filed its form 10-Q with the SEC and hosted a conference call to review the year's accomplishments.
Highlights for year to date 2021 include:
➢ Launched ADC program with Califia Pharma - January 2021
➢ Raised $69 million in equity - January 2021
➢ Signed agreement with Piramal Pharma for fill and finish of LP-300 - January 2021
➢ Filed 10+ patent applications - YTD 2021
➢ Surpassed accumulation of 4.6 billion curated datapoints using RADR - April 2021
➢ Expanded LP-184 into ATRT indication - April 2021
➢ Started Actuate Therapeutics collaboration using RADR for GSK3β drug candidate 9-ING-41 - May 2021
➢ Initiated development of LP-284 in hematologic cancers - 1Q:21
➢ Published peer-reviewed studies of RADR and LP-184
Lantern generated no revenues in the first quarter and expended $2.45 million on operations during the three month period producing a net loss of ($2.45) million, or ($0.24) per share.
For the first quarter ending March 31, 2021 and versus the first quarter ending March 31, 2020:
➢ Research & development expenses totaled $1.28 million, rising 833% from $137,000, on increases in product candidate manufacturing costs, employee-associated expenses, and research study expenses that totaled approximately $552,000, $228,000, and $180,000, respectively;
➢ General & administrative expenses rose 245% to $1.17 million from $340,000, driven primarily by corporate insurance expense of $440,000, business development expense of $112,000, general and administrative related stock option expense of $111,000;
➢ Net loss was ($2.45) million, or ($0.24) per share, compared to ($477,000), or ($0.24) per share;
As of March 31, 2021, cash on the balance sheet was $81.4 million. In April 2021, Lantern received notice that the Small Business Administration had authorized full forgiveness of the PPP loan of $108,500, which was borrowed in May 2020. Cash burn in the first quarter was ($2.1) million up markedly from the ($703,000) consumed in the matching prior year period.
Collaboration with Actuate Therapeutics
On May 3, 2021, Lantern announced that it had entered into a research and development collaboration with Actuate Therapeutics. In the collaboration, Lantern will apply its RADR Artificial Intelligence (AI) platform to the develop 9-ING-41, a glycogen synthase kinase-3β (GSK-3β) inhibitor targeting cancer and fibrotic diseases. 9-ING-41 is participating in multiple Phase II clinical trials targeting myelofibrosis and pancreatic cancer. Application of RADR is expected to speed the development of Actuate's lead candidate by identifying important biomarkers relevant to matching the right patient with the right drug. Using a biomarker for patient stratification can dramatically improve the likelihood of regulatory approval1. In the collaboration, Lantern will receive shares of Actuate stock based on meeting development milestones and may receive additional equity if results from the collaboration are utilized in future development efforts.
Actuate Therapeutics is a private biopharmaceutical company founded in 2015, with activities centered on agents that target GSK-3β, and based on intellectual capital developed in the laboratories of Dr. Alan Kozikowski at the University of Illinois-Chicago and the Center for Developmental Therapeutics at Northwestern University.
Publication of Preclinical Results in Oncotarget
Lantern announced on April 26, 2021 that it had published a manuscript entitled "The acylfulvene alkylating agent, LP-184, retains nanomolar potency in non-small cell lung cancer carrying otherwise therapy-refractory mutations." The article appeared in the journal Oncotarget, featuring preclinical evidence supporting the development of LP-184 in non-small cell lung cancers (NSCLCs) for patients ineligible for targeted therapy. The results demonstrated nanomolar potency in in vitro, drug-resistant lung cancer models of primary and metastatic NSCLC. The published results also demonstrated that LP-184 had higher in vitro potency than commonly prescribed platin and taxane-based chemotherapies. LP-184 maintained efficacy independent of KRAS or KEAP1 oncogenes and TP53 and STK11 tumor suppressor genes that commonly drive resistance. Furthermore, LP-184 showed tumor growth inhibition in a mouse xenograft model of KRAS and KEAP1 lung cancer, which occurs in about 17% of lung adenocarcinoma cases. Analysis of TCGA2 data for 517 lung adenocarcinoma patients showed 35% had elevated PTGR1 and 40% of those had statistically significant co-occurrence of KEAP1 mutations.
Publication of LP-184 Article in BMC Bioinformatics3
BMC Bioinformatics published an article on machine learning to predict response in cell lines and xenografts in March 2021. The study employed Lantern's RADR platform to identify biomarkers sensitive to LP-184. NCI-60 cell lines were used to derive the gene signatures and characterize sensitivity to the agent.
The model began with 20,000 gene expression values, systematically narrowing this down to a 16-gene signature that was able to predict LP-184 IC50 values with 86% accuracy. Machine learning has demonstrated an ability to identify responses at the preclinical stage, which allows for better positioning with regard to patient and indication as well as improving ultimate clinical success.
PTGR1 (Prostaglandin reductase 1) was found to be a necessary but insufficient requirement for LP-184 sensitivity and emerged as the top weighted gene in this study. The presence of PTGR1 is a determinant for the cytotoxicity of acylfulvenes and in this study represented almost half of the total variable importance in the identified markers. The identification of the importance of this gene will help clarify the mechanism of action of LP-184 and identify patients who may respond well to drugs such as Lantern's agent.
Phase II Clinical Trial For LP-300
Lantern expects to launch a Phase II trial for LP-300 in non-small cell lung cancer (NSCLC) patients that have never smoked in the third quarter of 2021. The company is interacting with the FDA and other regulatory bodies to refine the design of the trial and is seeking approval from investigators and institutional review boards. While not finalized, Lantern expects to use a combination treatment that includes doublet chemotherapy. The trial is expected to be a two-year, multi-center study enrolling 80 patients equally split between two arms of standard of care chemotherapy and standard of care chemotherapy + LP-300. Subjects will be diagnosed with adenocarcinoma NSCLC with little to no history of smoking and no prior chemotherapy. Beyond assessing the response to treatment in the target population, the trial will also serve to assess the efficacy of LP-300 in combination with chemotherapy on non-smokers, compare efficacy of LP-300 in non-smoking males and non-smoking females, further investigate safety, toxicity and tolerability and investigate biomarkers. Endpoints are expected to be overall survival, progression-free survival, objective response rate, identification of gene signatures correlated with potential LP-300 efficacy from matched tumor tissue analysis and protection against chemotherapy-induced nephrotoxicity.
LP-284
Lantern recently introduced its latest candidate, LP-284. This compound is the stereoisomer of LP-184 that has differentiated cancer-cell killing ability. LP-284 is being evaluated in hematological cancers, and, similar to LP-184, may be used with ADCs. Despite its matching chemical composition, the drug's mechanism of action is unique from LP-184 with respect to target indications, potency, metabolism, pharmacokinetics and toxicity.
Antibody Drug Conjugates (ADCs)
In January 2021 Lantern announced the launch of an antibody-drug conjugate (ADC) program through a partnership with San Diego-based Califia Pharma. ADCs are able to bind to a cancer cell, providing accurate delivery of a designated payload. Frequently, the ADC is endocytosed where the link is cleaved and the payload released. Lantern has matched several approved antibodies within its portfolio compatible with existing antibodies and linkers using its RADR5 AI algorithm. Encouraged by Gilead's $21 billion acquisition of ADC leader Immunomedics6, Lantern forged a relationship with Califia to link its existing candidates with proven antibodies to address cancers where drug resistance has created an unmet need. Antibody conjugation allows cancer-cell specific targeting of nanomolar-potent LP-184 enabling further efficacy in treatment-resistant cancers.
Using Califia's linkers, Lantern conducted lab work that demonstrated improved efficacy at lower doses when LP-184 was combined with existing cancer-targeting antibodies. The lower levels of drug also resulted in decreased toxicity. Califia's patented linkers, payloads and conjugations provide a construct to combine approved immuno-oncology antibodies with Lantern's alkylating and DNA damaging agents. ADC development will target both solid tumors and blood cancers where drug resistance and systemic toxicity are key issues. Lantern's LP-100 is also being considered for the approach using ADCs.
Lantern is considering the pursuit of multiple targets in the ADC combination program including colorectal, pancreatic, lung and ovarian cancer. From 5% to 10% of these cancers present the targeted biomarkers and compose the addressable market for the program. For additional discussion of ADCs, antibodies, linkers, and Califia Pharma, please refer to our previous report here.
New Indications For LP-184 - Atypical Teratoid Rhabdoid Tumors (ATRT)
Atypical teratoid rhabdoid tumors (ATRT) belong to a family of rhabdoid tumors (RT) that can arise in the liver, brain or central nervous system (CNS). 66% of RT arise in the brain and CNS and are known as ATRT. ATRT are a rare and rapidly proliferating cancer (Grade IV) of the brain and spinal cord. ATRT is considered ultra-rare. There are an estimated 58 pediatric patients diagnosed per year, and an estimated 596 people below the age of majority with the disease in the US.8 Another 10 to 15 cases appear in adults each year. Estimates of the percentage of ATRT originating in the brain vary considerably, with estimates between 15%9 and 50%.10 The cancer occurs in less than 10% of pediatric brain tumors and is most frequently in children aged 3 and under. Symptoms of ATRT include morning headaches or headaches that are less painful after vomiting, change in activity levels and lethargy, loss of balance or trouble walking, asymmetric eye movements, and increased head size. Treatment is multi-modal including surgery, chemotherapy and radiation. Due to the location in the brain, the tumor is often unresectable. Survival rates are poor which are estimated to be 32.2% at five years.11 Most ATRT are caused by mutations in the SMARCB1 gene. This gene is responsible for tumor growth suppression and when mutated, is no longer able to suppress tumor formation.
Lantern Clinical Pipeline
$69 Million Public Offering
On January 20, 2021, Lantern announced the closing of a public offering that yielded $69 million gross and saw the full exercise of underwriter over-allotment option. The offer sold 4,928,571 shares of common stock at $14.00 per share, which included 642,856 in underwriter purchases. Gross proceeds amounted to $69 million and net proceeds were approximately $64 million.
With this successful capital raise, Lantern attracted investment from Black River, Corriente, Empery Asset Management, Altium Capital and 5T Capital among others. The raise is expected to allow completion of trials in brain cancers, more specifically ATRT. It is also expected to allow Lantern to launch Phase I trials for its ADC program. The additional cash is sufficient for Lantern to fund operations over the next several years and achieve identified milestones, independent of near-term fluctuations in capital markets.
Key Events
➢ IPO and initiation of trading on the NASDAQ – June 10, 2020
➢ Regulatory interaction for Phase II trial design, LP-300 – 2H:20
➢ Preclinical development of new candidate LP-284 – 1Q:21
➢ R&D collaboration with Actuate Therapeutics – May 2021
➢ Phase II launch of LP-300 – 3Q:21
➢ 10 billion data points - 2022
➢ Phase I launch of LP-184 – 4Q:21 to 1Q:22
Summary
Management anticipates 2021 to be a year of transformational growth and progress with six programs in the pipeline and a large war chest of cash to fund preclinical and clinical work for years to come. Later this year we anticipate the start of the Phase II LP-300 study in NSCLC among non-smokers, IND-enabling studies of LP-184 in multiple solid tumors, continued advancement of the ADC program and continued investment in RADR's growing dataset. Management also expects to disclose additional PTGR1 over-expressing tumors as indications for LP-184. LP-284 has emerged as a contender in hematologic cancers based on an evaluation by RADR and in-vitro studies.
With the recent $69 million raise, Lantern is now equipped to complete clinical trials in both GBM and ATRT, and Phase I trials in its ADC program. Commencement of Phase I ADC trials are expected as early as 4Q:21. For added detail on Lantern's proprietary AI development platform, RADR, and for background on indications and Lantern's clinical candidates, please refer to further discussion in our initiation.
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1. Parker, J.L., Kuzulugil, S.S., Pereverzev, K., Mac, S., Lopes, G., Shah, Z., Weerasinghe, A., Rubinger, D., Falconi, A., Bener, A., Caglayan, B., Tangri, R. and Mitsakakis, N. (2021), Does biomarker use in oncology improve clinical trial failure risk? A large‐scale analysis. Cancer Med, 10: 1955-1963. https://doi.org/10.1002/cam4.3732
2. The Cancer Genome Atlas
3. Kathad, U. et al. A machine learning-based gene signature of response to the novel alkylating agent LP-184 distinguishes its potential tumor indications. BMC Bioinformatics volume 22, Article number: 102 (2021). March 2021.
4. Source: Lantern Corporate Presentation, April 2021. Note the yellow circle which identifies where the orientation of LP-284 differs from LP-184.
5. Lantern's proprietary AI platform is entitled Response Algorithm for Drug Positioning and Rescue (RADR).
6. Immunomedics developed next-generation ADC technology and obtained FDA approval for Trodelvy in metastatic triple negative breast cancer in April 2020.
7. Polakis, Paul. Antibody Drug Conjugates for Cancer Therapy. Pharmacological Reviews, January 2016.
8. Atypical Teratoid Rhabdoid Tumors (ATRT) Diagnosis and Treatment - National Cancer Institute
9. Rhabdoid tumor | Genetic and Rare Diseases Information Center (GARD) – an NCATS Program (nih.gov)
10. Atypical Teratoid Rhabdoid Tumor (ATRT) - St. Jude Children's Research Hospital
11. Atypical Teratoid Rhabdoid Tumors (ATRT) Diagnosis and Treatment - National Cancer Institute
12. Source: Lantern Pharma 1Q:21 Corporate Presentation, May 3, 2021.
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