LTRN: 2Q:23 Quarterly Update
NASDAQ:LTRN
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On August 9, 2023, Lantern Pharma, Inc. (NASDAQ:LTRN) announced 2Q:23 financial and operational results, filed its Form 10-Q with the SEC and hosted a video webcast to review accomplishments. Since the beginning of the second quarter, Lantern has further enrolled its Phase II Harmonic study, developed a collaboration with Bielefeld University and received clearance for its LP-184 study in solid and CNS tumors. Other important achievements 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
➢ ADC collaboration with Bielefeld University – June 2023
➢ IND clearance for LP-184 – June 2023
➢ Publication of LP-284 data in Oncotarget – June 2023
Lantern generated no revenue in 2Q:23 and incurred operating expense of $5.2 million, producing a net loss of ($4.7) million or ($0.44) per share.
For the quarter ending June 30, 2023 and versus the same comparable prior year period:
➢ Research & development expenses totaled $3.6 million, rising 19% from $3.0 million on account of greater research study expenditure and increases in payroll and compensation. These amounts were offset by decreases in product candidate manufacturing expenses and lower consulting expenses;
➢ General & administrative expenses were $1.6 million, rising 16% from $1.4 million. The following expense categories drove the increase: payroll and compensation, other professional fees, business development, travel expenses, legal and patent expense and rent. These amounts were partially offset by lower corporate insurance costs;
➢ Interest income was $118,000 versus $55,000 while other income was $326,000 versus a loss of ($153,000). Increases in dividend income, tax incentives from Australia, and a reduction in foreign currency loss contributed to the change;
➢ Net loss was ($4.7) million, or ($0.44) per share, compared to ($4.5) million, or ($0.41) per share.
At the end of 2Q:23 cash and marketable securities on the balance sheet totaled $47.9 million, declining $7.2 million over the six months since year end 2022. Cash burn for 2Q:23 was ($3.6) million versus ($2.7) million in the prior year period. No financing cash flows were recorded in 2Q:23 or in 2Q:22.
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 Phase II effort led by lead principal investigator Dr. Joseph Treat of Fox Chase Cancer Center. 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 and Asia are expected, especially in regions where never-smoker NSCLC are prevalent. Enrollment is anticipated to take 18-24 months.
Lantern expects to report details from the first stage of Harmonic as they become available. Genomic and transcriptomic data collected from subject biopsies will be used to further refine subject identification and potential responders. Investigators have identified a higher incidence of low PD-L1 expression in responders, highlighting this as an important marker and potential signature for identifying LP-300 candidates.
LP-284 Progress
Patent Notice of Allowance
The United States Patent and Trademark Office (USPTO) issued a notice of allowance2 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.
LP-184 Progress
In mid-January 2023, Lantern announced the receipt of feedback from the FDA regarding its anticipated LP-184 investigational new drug (IND) submission. A June 12th press release memorialized the FDA’s clearance of the IND application for LP-184 in solid tumors. As of the 2Q:23 quarterly report date, the Phase Ia study has now activated initial clinical sites and should begin screening subjects with multiple advanced solid tumors and brain and central nervous system (CNS) cancers. A clinicaltrials.gov entry was created under the National Clinical Trial identifier NCT05933265. Up to 36 subjects are anticipated to be enrolled in the trial which is expected to be complete by the first half of 2024. Upon successful completion, Phase II studies in multiple solid tumor indications will be pursued by Lantern and brain and CNS indications will be pursued by Lantern’s subsidiary, Starlight Therapeutics.
The goals of the trial are to evaluate the safety, tolerability, maximum tolerated dose (MTD) and identify a dose to be used in the anticipated Phase II trial. Eligible patients will be enrolled to receive LP-184 treatment at a dose determined based on the available cohort at the time of his or her enrollment. Patients will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Subjects will be monitored for safety, pharmacokinetics and clinical activity. Dose escalation is planned with a minimum of three patient cohorts (starting at dose level 1). After selection of the MTD, additional patients will be enrolled at two dose levels, including the MTD, as determined by the Safety Review Committee, until at least 10 patients each are treated at each dose to determine the recommended Phase II dose.
Bielefeld University Collaboration
Lantern, in collaboration with Germany’s Bielefeld University, is developing its AI platform to design cryptophycin antibody drug conjugates (ADCs).4 Lantern’s RADR will be used to develop ADCs that will provide it an exclusive worldwide license to develop and commercialize new candidates in the class. Lantern will use its ADC module along with research developed by Professor Norbert Sewald to design next-generation ADCs that offer potentially higher efficacy and more rapidly developed candidates at a lower cost. Initial work will be done with cryptophycins, which offer potency at pico-molar concentrations. The collaboration aims to de-risk the ADC development process and improve their creation. Under the terms of the collaboration, Dr. Sewald and his group will synthesize, optimize, and provide initial testing of the cryptophycin-ADCs.
Oncotarget Article
A June 26th release highlighted a publication which provided in vitro and in vivo data for LP-284 for mantle cell lymphoma (MCL), a subtype of non-Hodgkin’s lymphoma (NHL). The article was published in Oncotarget and titled “LP-284, a small molecule acylfulvene, exerts potent antitumor activity in preclinical non-Hodgkin's lymphoma models and in cells deficient in DNA damage repair.” The article noted that 20-40% of NHL patients experience relapse or refractory disease. This cancer represents and unmet need that may be addressed by LP-284 given the molecules differentiated mechanism of action.
The small molecule acylfulvene employs synthetic lethality to induce DNA double strand breaks and is able to be effective in vivo after developing resistance to bortezomib or ibrutinib which are proteasome and BTK inhibitors respectively. Bortezomib and ibrutinib are frequently used to treat NHL. Cells are sensitized to LP-284 when the molecule is used in combination with spironolactone, a hypertension drug. Failure to repair double strand breaks or homologous recombination repair (HR) deficiency increases NHL cells’ sensitivity to LP-284, targeting HR-deficient NHL patients with LP-284 is likely to produce better treatment outcomes.
The study the article was based on concluded that LP-284 is a novel and potent acylfulvene drug that can suppress tumor growth in NHL models and cells with HR or transcription coupled nucleotide excision repair (TC-NER) deficiency. LP-284 may be able to treat patients that are resistant to other lines of treatment, especially with certain genetic features. An investigational new drug (IND) application for LP-284 is expected to be filed in 2H:23 to begin a Phase I trial and pursue an indication in NHL.
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1. Source: Lantern Pharma 2Q:23 Corporate Presentation, August 9, 2023
2. 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.
3. Source: Lantern Pharma 1Q:23 Corporate Presentation, May 9, 2023
4. Cryptophycins are a class of cyclic depsipeptides with anticancer properties.
5. Source: Lantern Pharma 2Q:23 Corporate Presentation, August 9, 2023
