LTRN: 2022 Financial and Operational Results
NASDAQ:LTRN
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On March 20, 2023, Lantern Pharma, Inc. (NASDAQ:LTRN) announced 2022 financial and operational results, filed its Form 10-Q with the SEC and hosted a video webcast to review accomplishments. Since our previous update, Lantern has created the Starlight Therapeutics subsidiary, presented new data for LP-100, expanded its clinical leadership team, presented LP-184 at AACR and developed a roadmap for ADC development. The company also announced that it has activated five clinical trial sites and expects to enroll its first subjects in the HARMONIC trial in 2Q:23.
Highlights for 2022 and to-date include:
➢ FDA Authorization to start LP-300 trial – July 2022
➢ LP-184 data presented at AACR – September 2022
➢ KOL Webinar, Pediatric Cancers – September 2022
➢ LP-284 data for mantle cell lymphoma presented at SOHO – September 2022
➢ Publication in Frontiers in Drug Discovery – October 2022
➢ New patent issued for LP-300 – October 2022
➢ Positive data for LP-184 in GBM presented at SNO – November 2022
➢ Orphan drug designation for LP-284 in mantle cell lymphoma – January 2023
➢ AI collaboration with TTC Oncology – February 2023
➢ Addition of Dr. Reggie Ewesuedo M.D., VP of Clinical Development – March 2023
➢ Formation of Starlight Therapeutics – March 2023
➢ Refined direction for LP-100 with PARPi in prostate cancer – March 2023
Lantern generated no revenues in 2022 and incurred operating expense of $14.4 million, producing a net loss of ($14.3) million or ($1.31) per share.
For the year ending December 31, 2022 and versus the same comparable prior year period:
➢ Research & development expenses totaled $8.6 million, rising 14% from $7.6 million on account of rising consulting expenses as well as research and development payroll expenses. These increases were partially offset by decreases in product candidate manufacturing related expenses, decreases in licensing fees and a net decline in payments to licensing partners. Manufacturing related expenses fell as a result of a payment received from a service provider;
➢ General & administrative expenses were $5.8 million, rising 16% from $5.0 million. The following expense categories drove the increase: payroll and compensation, other professional fees, legal and patent expenses, travel expenses and other expenses. This was partially offset by decreases in business development expenses and corporate insurance;
➢ Interest income was $204,000 versus $68,000 while other (expense) income shifted to a loss of ($32,000) versus a gain of $161,000. The amount in other expense was attributable to increases in unrealized losses on investments, increase in foreign currency loses and a one-time gain from loan forgiveness among other minor items;
➢ Net loss was ($14.3) million, or ($1.31) per share, compared to ($12.4) million, or ($1.13) per share.
At the end of 2022 cash and marketable securities on the balance sheet totaled $55.2 million, declining $15.5 million compared to year end 2021. Cash burn for 2022 was ($12.8) million versus ($10.6) million in the prior year period. Cash used in financing was ($2.2) million with ($2.5) million of share repurchases partially offset by $0.3 million in warrant and option proceeds.
Starlight Therapeutics
In a March 6th press release, Lantern Pharma announced that it had created a new subsidiary that will hold rights to LP-184 for use in central nervous system (CNS) cancers. As part of the creation of the new entity, LP-184 will be renamed STAR-001 with the objective of pursuing CNS cancers with limited or no effective therapeutic options. Creating a subsidiary will make it easier to work with partners and potentially spin out this entity with its own funding, providing access for shareholders, patients and potential acquirors to an attractive segment of oncology that is not hindered by collateral indications.
Lantern expects to begin clinical trials in the designated cancer indications in late 2023 and 2024. In mid-2023, Lantern anticipates the start of a Phase Ia basket trial for LP-184 that will investigate recurrent brain cancers, metastatic CNS cancers, pancreatic cancer and solid tumors with DDR deficiencies. Starlight will have access to Lantern’s RADR platform to advance targeted and efficient clinical development programs.
There are a number of potential benefits to creating a subsidiary to hold the CNS indications depending on the ultimate direction taken by the programs in Starlight. Flexibility, branding, access to resources and tax treatment are some of the primary benefits we see from the move. Starlight can also enter into its own agreements with partners and can be bought by another pharmaceutical company that wants access to CNS cancer therapeutics.
STAR-001
STAR-001 is the new designation for LP-184 when used in central nervous system (CNS) tumors under the Starlight Therapeutics banner. This asset is in preclinical development for multiple indications including glioblastoma (GBM), brain metastases in the lung, breast and skin, Atypical Teratoid Rhabdoid Tumors (ATRTs) and pediatric brain cancers. Several of these indications are eligible for orphan status including GBM, ATRT and pediatric brain cancers. ATRT has been granted a rare pediatric disease designation, which provides a priority review voucher if the pediatric indication is approved.
Favorable data has been observed for each of these indications. This includes the ability of STAR-001 to cross the blood brain barrier, induce tumor regression, and offer potent efficacy in specific cancer cell lines. The drug is amenable to combination therapies and has shown in-vitro potency with spironolactone
AACR Presentation
Lantern will present at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida on April 19th, 2023. The abstract for the presentation examines the role of DNA damage response (DDR) pathways and LP-184 in cancers that exhibit these characteristics. DDR pathways allow tumor cells to persist rather than undergo apoptosis. The abstract notes that up to a third of solid tumor cancers have a deficiency in the DDR pathways and they are vulnerable to DDR inhibitors allowing next generation acylfulvenes such as LP-184 to produce synthetic lethality in tumor cells. Synthetic lethality is a concept in oncology that refers to the idea that cancer cells that carry certain mutations or genetic alterations can be selectively killed by targeting a second, functionally related gene or pathway. LP-184 can be synthetically lethal due to its ability to cause unresolvable DNA damage if tumor cells express high prostaglandin reductase 1 (PTGR1)2 and are deficient in nucleotide excision repair (NER) / homologous repair (HR) genes. Unlike poly ADP-ribose polymerase inhibitors (PARPi), LP-184 can induce cell death in both NER deficient as well as HR deficient cancers.
LP-100 and PARP Inhibitors
LP-100 was recently reacquired from Allarity Therapeutics following the latter’s Phase II work in prostate cancer. After evaluating all of the relevant data available including in silico analysis from patient data sets using RADR, Lantern has identified a promising indication in homologous repair (HR) deficient cancers such as metastatic prostate (mCRPC) and other cancers where PARPis are being used. A new clinical trial is being considered in cancers with mutations in DDR genes such as BRCA1/2 and ATM, which will build upon the prior Phase II work conducted in metastatic castration-resistant prostate cancer.
Lantern conducted prostate cancer mouse xenograft studies, showing synergistic potency of LP-100 when used with PARPi Olaparib. LP-100 was also synergistic with Olaparib, Rucaparib and Niraparib in ovarian cancer cell line studies. The combination’s mechanism of action induces synthetic lethality by preventing repair of double strand breaks in the DNA leading to cell apoptosis. We expect to see further development efforts for LP-100 be conducted in combination with PARP inhibitors. The new approach is expected to expand the potential market size and position the drug in multiple genomically defined DDR cancers.
Antibody Drug Conjugate Development
In mid-February, Lantern provided a roadmap for the development of antibody drug conjugates (ADCs) for targeted delivery of cytotoxic drugs to tumor cells. ADCs are a class of drug that binds to target cells using an antibody to deliver a toxin or other small molecule. The conjugate combines the specificity of monoclonal antibodies with the cytotoxic potency of chemotherapy drugs. ADCs consist of three components: an antibody, a linker, and a cytotoxic drug molecule. ADCs allow for the selective delivery of cytotoxic drugs to cancer cells while sparing normal cells, thereby reducing off-target toxicity and improving the efficacy of chemotherapy.
The company plans to use the prestige of its AI and ML platform to enhance the development of novel and effective ADCs for the targeted delivery of potent anti-cancer small molecules to cancer cells. It expects to improve the cost, pace and timeline of drug discovery and development through the use of its RADR platform. A roadmap was provided highlighting several features of the effort. These include use of algorithms to 1) predict optimal combinations of ADC components, 2) generate biomarker signatures that can predict a cancer’s sensitivity to an ADC, 3) identify potential synergies and 4) predict the immunogenicity of ADC antibodies to cancer cell surface antigens. The strategy will enable the large-scale analysis of thousands of high-performing model features through their SHAP3 scores to efficiently identify key genes and pathways that are mechanistically important to drug resistance, quality of patient outcomes, and improved delivery of ADC drug payloads.
ADCs have been in the news recently with the announcement of Pfizer’s (PFE) plans to acquire Seagen (SGEN) for $43 billion. Formerly Seattle Genetics, Seagen is a pioneer in the development of ADCs, and has successfully commercialized three ADC assets including Adcetris, Padcev and Tivdak. Other recent acquisitions in the space include Gilead’s (GILD) buy of Immunomedics and Merck’s (MRK) acquisition of VelosBio.
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1. Source: Lantern press release, March 6, 2023.
2. PTGR1 is an enzyme that is involved in the metabolism of prostaglandins, which are small lipid molecules that play important roles in various physiological and pathological processes, including inflammation and cancer.
3. A Shapley Additive Explanation (SHAP) score is a method for explaining the output of machine learning models by measuring the contribution of each input feature to the model's prediction. It is based on the Shapley value from cooperative game theory, which measures the marginal contribution of each player to a coalition.
