LTRN: First Harmonic Patient Dosed
NASDAQ:LTRN
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2022 Financial and Operational Results
On May 9, 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. In the last six weeks, Lantern has dosed its first patient in the Phase II Harmonic study, announced receipt of a patent allowance by the USPTO and continues development of algorithms to optimize medicine use. Other important items achieved year to date include creation of the Starlight Therapeutics subsidiary, multiple conference presentations of new data, expansion of the clinical leadership team, and creation of a roadmap for ADC development.
Highlights for 2022 and to-date include:
➢ 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
➢ First patient dosed in Harmonic trial – March 2023
Lantern generated no revenue in 1Q:23 and incurred operating expense of $4.3 million, producing a net loss of ($3.9) million or ($0.36) per share.
For the quarter ending March 31, 2023 and versus the same comparable prior year period:
➢ Research & development expenses totaled $2.6 million, falling 4% from $2.7 million on account of lower expenditures for the LP-300 program offset by increases in in spending on LP-184 and LP-284. Additional funds were allocated to the RADR platform. On an overall basis, the change in spending was attributable to lower product candidate manufacturing expenses, as well as lower consulting expenses and licensing fees. These amounts were partially offset by more spending on research studies and compensation expenses;
➢ General & administrative expenses were $1.7 million, rising 23% from $1.4 million. The following expense categories drove the increase: payroll and compensation, other professional fees, travel expenses and other expenses. This was partially offset by decreases in legal and patent expenses and corporate insurance;
➢ Interest income was $134,000 versus $22,000 while other income was $285,000 versus a loss of ($78,000). The amount in other expense was attributable to increases in dividend income, gains on investments and research and development incentives from the Australia subsidiary which were partially offset by foreign currency loses;
➢ Net loss was ($3.9) million, or ($0.36) per share, compared to ($4.1) million, or ($0.38) per share.
At the end of 1Q:23 cash and marketable securities on the balance sheet totaled $51.5 million, declining $3.7 million over the three months since year end 2022. Cash burn for 1Q:23 was ($3.8) million versus ($3.3) million in the prior year period. No financing cash flows were recorded in 1Q:23 compared to a use of ($2.2) million in 1Q:22, with amounts in the prior period related to share repurchases.
Harmonic Trial
In July 2022, Lantern announced the start of the Harmonic trial that will evaluate LP-300 in never smokers with non-small cell lung cancer (NSCLC). 90 subjects are expected to enroll in the Phase II study at 15 to 20 sites around the United States with enrollment expected to last from 12 to 16 months. It will target never smokers with lung adenocarcinoma who have relapsed after treatment with tyrosine kinase inhibitors (TKIs). The study will consist of two stages, the safety lead-in stage and the randomization stage. Patients on LP-300 + pemetrexed and carboplatin will be measured against patients on pemetrexed and carboplatin only in a 2:1 ratio. Primary endpoints are progression free survival (PFS) and overall survival (OS). Secondary endpoints include objective response rate (ORR), duration of objective response (DOR) and clinical benefit rate (CBR). The trial will also collect liquid biopsies and acquire genomic and transcriptomic data from patients.
A March 28th, 2023 press release announced that the first patient in the trial had been dosed, kicking off the next stage in the Phase II effort. Lantern has activated five clinical trial sites including Gabrail Cancer Center, Northwest Oncology, New York Cancer and Blood Specialists, Texas Oncology and Cancer and Blood Specialty Clinic. Further trial sites across the United States are also expected to be activated in 1H:23. As of the date of the press release, there were 14 additional potential patients that had been pre-screened and being considered for enrollment.
LP-184 Progress
In mid-January, Lantern announced the receipt of feedback from the FDA regarding its anticipated LP-184 investigational new drug (IND) submission. In 4Q:22, Lantern requested the pre-IND meeting with the agency to ensure that the IND submission would address all of the FDA’s concerns. The submission is expected in the near term, and if there are no outstanding questions, clearance could arrive in time for a trial to start in 2Q:23. The related study will look at a variety of solid tumors including those related to pancreatic cancer, solid tumors with DNA damage repair deficiency and malignant gliomas, including glioblastoma. It is expected to enroll from 30 to 35 subjects.
AACR Presentation
Lantern presented at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida on April 19th, 2023. The abstract for the presentation reviews 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. Combination therapies with LP-184 and PARPi appear to provide compelling synergies where the former is able to force double DNA strand breaks in cancerous cells and the latter blocks their repair.
LP-284 Progress
Patent Notice of Allowance
The United States Patent and Trademark Office (USPTO) issued a notice of allowance3 for patent application 17/192,838 entitled Illudin analogs, uses thereof, and methods for synthesizing the same. The composition of matter patent covers LP-284. Examples in the application include novel synthetic routes to prepare illudin derivatives and an illudin derivative presenting a positive optical rotation, which has therapeutic value. The molecule is intended to be used in non-Hodgkin’s lymphomas and potentially other hematological malignancies. A Phase I trial is planned for later in 2023 with the LP-284 candidate. Lantern expects the resulting LP-284 patent will be Orange Book-listable with an anticipated expiration of early 2039. Similar patent rights are expected to be obtained for LP-284 in Europe, Japan, India, China, Australia, Canada, and Korea.
Orphan Drug Designation for LP-284 in MCL
Starting off the year with positive news, Lantern’s first press release for 2023 announced the FDA’s grant of orphan drug status to LP-284 in mantle cell lymphoma (MCL). According to the National Organization for Rare Disorders (NORD), MCL is a type of non-Hodgkin’s lymphoma that affects every one out of 200,000 individuals or about 1700 persons. Lantern plans to file a related IND for LP-284 in B-cell non-Hodgkin’s lymphomas, including MCL by mid-2023.
Orphan drug designation grants several benefits to awardees including tax credits for qualified clinical trials, exemption from user fees and seven years of exclusivity after approval. In the United States, the status may be given to products that address diseases affecting fewer than 200,000 persons. Similar benefits are available in other regions outside the United States, and ten years of exclusivity is offered in the European Union. These incentives may be available if Lantern seeks and is granted orphan designations in these areas. This is the fourth orphan designation granted to Lantern with others for indications in malignant gliomas, atypical teratoid rhabdoid tumors and pancreatic cancer.
New Algorithm to Predict Blood Brain Barrier Permeability
Lantern’s RADR artificial intelligence and machine learning platform has developed algorithms to predict the ability of a drug or compound to cross the blood-brain-barrier (BBB). The BBB blocks most compounds and pathogens that may circulate in the bloodstream while allowing in necessary nutrients and special molecules to pass. The algorithm has shown a prediction accuracy of 89-92% as reported by the company. It employs a combination of proprietary automated feature selection methods along with specialized hyper parameter optimization that integrates algorithms using an ensemble approach to quickly provide a compound’s BBB permeability range. This approach allows for high throughput and ultra-fast BBB permeability analysis compared to traditional discovery and evaluation methods.
Lantern’s RADR competed in a challenge that compared the output of the AI model against 1,975 compounds where the BBB permeability was known. Based on the results posted in the TD Commons Leaderboard, Lantern’s RADR took the top four spots. Lantern’s wholly owned subsidiary, Starlight Therapeutics which is focused on CNS cancers, will have access to the tool.
While explicit details on inputs were not provided in the press release, AI and ML models may be trained on the molecular weight, lipophilicity, and polar surface area of drugs, which are known to influence BBB permeability. Other approaches may learn complex patterns and relationships between drug properties and BBB permeability, and can make more accurate predictions than traditional machine learning models.
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1. Source: Lantern Pharma 1Q:23 Corporate Presentation, May 9, 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 patent notice of allowance is an official notification from a patent examiner indicating that a patent application has been approved for issuance as a patent. The notice indicates that the patent examiner has reviewed the application and found that it meets the legal and technical requirements for patentability.
