Lantern Pharma Receives FDA Authorization to Initiate its Phase 2 Clinical Trial, Harmonic™, for LP-300 in Never Smokers with Non-Small Cell Lung Cancer

• The Harmonic™ trial is a Phase 2 multi-center study focused on never smokers with advanced non-small cell lung cancer (NSCLC) and will begin patient enrollment during Q3 2022.
• In a previous Phase 3 multi-center clinical trial, a subset of never smoker patients with NSCLC receiving LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who received chemotherapy alone.
• In the US in 2021 there were an estimated 24,000 to 30,000 never smoker patients diagnosed with NSCLC.

Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR^® artificial intelligence ("A.I.") and machine learning (“ML”) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced that the Food and Drug Administration (FDA) has cleared the Company to proceed with its Phase 2 clinical trial, Harmonic™, for its investigational new drug LP-300. The Harmonic™ trial will be a 90 patient, multi-center, two arm, open-label, and randomized clinical trial evaluating LP-300 in combination with chemotherapy for never smoker patients with advanced non-small cell lung cancer (NSCLC).

“The launch of the Harmonic™ trial is a major milestone for LP-300. Our team is looking forward to beginning patient enrollment during the third quarter,” said Panna Sharma, CEO and President of Lantern. “LP-300 is an innovative therapy that is being developed for never smokers with NSCLC, a unique and growing population of lung cancer patients whose cancer is genetically different from smokers with lung cancer. LP-300 will be delivered in combination with standard of care chemotherapy. Importantly, LP-300 has been well tolerated in prior clinical trials and has shown potential to protect against harmful effects of chemotherapy while also de-naturing many of the tyrosine kinase receptors through cysteine modification that are involved with NSCLC,” continued Sharma.

About the Harmonic™ Trial and LP-300:

The Harmonic™ trial is a Phase 2 clinical trial that will assess the effect of Lantern’s investigational new drug LP-300 in combination with standard of care (SOC) chemotherapy, pemetrexed and carboplatin, on the overall and progression-free survival of never smoker patients with advanced NSCLC. The study has been designed as a 90 patient trial with approximately 2/3^rds of the patients receiving LP-300 with chemotherapy and the remaining 1/3^rd receiving chemotherapy alone. Lantern expects that initial patients will be enrolled into the Harmonic™ trial during the third quarter of 2022. Enrollment is expected to occur over the next 12 to 16 months across multiple sites in the US.

In a previous multi-center Phase 3 clinical trial, a subset of never smoker NSCLC patients who received LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who only received chemotherapy. In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated. LP-300 has also exhibited chemoprotective properties that may reduce side effects from chemotherapy. Additional information on the Harmonic™ trial can be found in the table below and at the link for the study’s registration and listing on the ClinicalTrials.gov website https://clinicaltrials.gov/ct2/show/NCT05456256.

About Lung Cancer in Never Smokers:

According to the American Cancer Society lung cancer is the second leading cause of cancer in the US. In 2021 there were an estimated 218,000 total patients diagnosed with lung cancer representing approximately a $11.5 billion market size. Historically, never smokers with NSCLC make up about 15-20% of all lung cancer patients, representing an approximate market size of $1.5 to 2.0 billion.

NSCLC presents differently in never smokers, which are defined by the CDC as a person who has smoked 100 cigarettes or less in their life, compared to smokers. These differences are believed due to a higher percentage of genetic mutations in a family of cancer-promoting genes called Tyrosine Kinases (TK). Changes in TK genes, such as EGFR, ALK, ROS and MET, can contribute to the development of healthy cells into cancer cells, leading to tumor formation and growth. LP-300’s intended mechanism is to work together with chemotherapy by strongly interacting in the TK gene pathways, interrupting their activity to slow or prevent tumor growth and spread.

About Lantern Pharma:

Lantern Pharma (NASDAQ: LTRN) is a clinical-stage oncology-focused biopharmaceutical company leveraging its proprietary RADR^® A.I. and machine learning platform to discover biomarker signatures that identify patients most likely to respond to its pipeline of genomically targeted therapeutics. Lantern is currently developing four drug candidates and an ADC program across nine disclosed tumor targets, including two phase 2 programs. By targeting drugs to patients whose genomic profile identifies them as having the highest probability of benefiting from the drug, Lantern's drug development approach represents the potential to deliver best-in-class outcomes. Lantern is also partnering with leading academic institutions including Johns Hopkins, Fox Chase Cancer Center, and UT Health Science Center – San Antonio to accelerate the development of Lantern’s drug programs.

Please find more information at:

Website: www.lanternpharma.com

LinkedIn: https://www.linkedin.com/company/lanternpharma/

Twitter: @lanternpharma

Forward-looking Statements

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