Lantern Pharma Inc

Previous wording

We are a clinical stage biotechnology company, focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic data to streamline the drug development process and to identify the patients that will benefit from our targeted oncology therapies. Our portfolio of therapies consists of small molecules that others have tried, but failed, to develop into an approved commercialized drug, as well as new compounds that we are developing with the assistance of our proprietary A.I. platform and our biomarker driven approach. Our A.I. platform, known as RADR®, currently includes more than 60 billion data points, and uses big data analytics (combining molecular data, drug efficacy data, data from historical studies, data from scientific literature, phenotypic data from trials and publications, and mechanistic pathway data) and machine learning to rapidly uncover biologically relevant genomic signatures correlated to drug response, and then identify the cancer patients that we believe may benefit most from our compounds. This data-driven, genomically-targeted and biomarker-driven approach allows us to pursue a transformational drug development strategy that identifies, rescues or develops, and advances potential small molecule drug candidates at what we believe is a fraction of the time and cost associated with traditional cancer drug development.

Current wording

We are a clinical stage biotechnology company, focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic data to streamline the drug development process and to identify the patients that will benefit from our targeted oncology therapies. Our portfolio of therapies consists of small molecules that others have tried, but failed, to develop into an approved commercialized drug, as well as new compounds that we are developing with the assistance of our proprietary A.I. platform and our biomarker driven approach. Our A.I. platform, known as RADR®, currently includes more than 100 billion data points, and uses big data analytics (combining molecular data, drug efficacy data, data from historical studies, data from scientific literature, phenotypic data from trials and publications, and mechanistic pathway data) and machine learning to rapidly uncover biologically relevant genomic signatures correlated to drug response, and then identify the cancer patients that we believe may benefit most from our compounds. This data-driven, genomically-targeted and biomarker-driven approach allows us to pursue a transformational drug development strategy that identifies, rescues or develops, and advances potential small molecule drug candidates at what we believe is a fraction of the time and cost associated with traditional cancer drug development.

Previous wording

We are currently conducting a targeted phase 2 trial (the Harmonic™ trial) for LP-300 in never smoking patients with NSCLC in combination with chemotherapy, under an existing investigational new drug application. Our candidate LP-184 has shown promisingin-vitroandin vivo anticancer activity in multiple solid tumor indications (including pancreatic, glioblastoma and triple negative breast cancer), and it is advancing in a Phase 1A clinical trial that commenced in mid-2023. Our candidate LP-284 has shown promisingin-vitroandin vivo anticancer activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184. LP-284 is advancing in a Phase 1A clinical trial that commenced in the fourth quarter of 2023.

Current wording

We are currently conducting a targeted phase 2 trial (the Harmonic™ trial) for LP-300 in never smoking patients with advanced non-small cell lung cancer (“NSCLC”) in combination with chemotherapy, under an existing investigational new drug application. Our candidate LP-184 has shown promisingin-vitroandin vivo anticancer activity in multiple solid tumor indications (including pancreatic, glioblastoma and triple negative breast cancer), and it is advancing in a Phase 1A clinical trial that commenced in mid-2023. Our candidate LP-284 has shown promisingin-vitroandin vivo anticancer activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184. LP-284 is advancing in a Phase 1A clinical trial that commenced in the fourth quarter of 2023.

Previous wording

To date, except for a prior research grant, we have not generated any revenue, we have incurred net losses and our operations have been financed primarily by sales of our equity securities. Our net losses were approximately $5,441,000 and $3,868,000 for the three months ended March 31, 2024 and 2023, respectively.

Current wording

To date, except for a prior research grant, we have not generated any revenue, we have incurred net losses and our operations have been financed primarily by sales of our equity securities. Our net losses were approximately $10,400,000 and $8,614,000 for the six months ended June 30, 2024 and 2023, respectively.

Previous wording

We did not recognize revenues for the three-month periods ended March 31, 2024 and 2023.

Current wording

We did not recognize revenues for the three and six-month periods ended June 30, 2024 and 2023.

Previous wording

Our research and development expenses by project category for the three months ended March 31, 2024 and 2023 are as follows:

Current wording

Our research and development expenses by project category for the three and six months ended June 30, 2024 are as follows:

Previous wording

Summary Results of Operations for the Three Months Ended March 31, 2024 and 2023 (unaudited)

Current wording

Summary Results of Operations for the Three and Six Months Ended June 30, 2024 and 2023 (unaudited)

Previous wording

General and administrative expenses decreased approximately $252,000, or 15%, from approximately $1,733,000 for the three months ended March 31, 2023 to approximately $1,481,000 for the three months ended March 31, 2024. The decrease was primarily attributable to decreases in payroll and compensation expenses of approximately $131,000, decreases in insurance expenses of approximately $121,000, decreases in other professional fees of approximately $69,000 and decreases in office and administrative fees of approximately $66,000. This was partially offset by increases in business development expenses of approximately $57,000, increases in legal and patent related expenses of approximately $49,000, and increases in travel expenses of approximately $29,000. General and administrative expenses for the three months ended March 31, 2024 and the three months ended March 31, 2023 included administrative expenses relating to our wholly-owned subsidiaries, including Starlight Therapeutics Inc., which was formed in January 2023.

Current wording

General and administrative expenses decreased approximately $112,000, or 7%, from approximately $1,632,000 for the three months ended June 30, 2023 to approximately $1,520,000 for the three months ended June 30, 2024. The decrease was primarily attributable to decreases in payroll and compensation expenses of approximately $139,000, decreases in insurance expenses of approximately $97,000, decreases in business development expenses of approximately $27,000, and decreases in office and administrative fees of approximately $22,000. This was partially offset by increases in other professional fees of approximately $106,000 and increases in patent and legal fees of approximately $69,000. General and administrative expenses for the three months ended June 30, 2024 and 2023 included administrative expenses relating to our wholly-owned subsidiaries, including Starlight Therapeutics Inc., which was formed in January 2023.

Previous wording

Research and development expenses increased approximately $1,698,000, or 67%, from approximately $2,553,000 for the three months ended March 31, 2023 to approximately $4,251,000 for the three months ended March 31, 2024. The increase was attributable to increases in research studies of approximately $1,544,000, increases in payroll and compensation expenses of approximately $288,000, and increases in consulting expenses of approximately $70,000. This was partially offset by decreases in product candidate manufacturing expenses of approximately $204,000.

Current wording

Research and development expenses increased approximately $331,000, or 9%, from approximately $3,558,000 for the three months ended June 30, 2023 to approximately $3,889,000 for the three months ended June 30, 2024. The increase was attributable to increases in research studies of approximately $724,000, increases in consulting expenses of approximately $187,000 and increases in payroll and compensation expenses of approximately $122,000. This was partially offset by decreases in manufacturing expenses of approximately $702,000.

Previous wording

Interest income increased approximately $67,000, or 50%, from approximately $134,000 for the three months ended March 31, 2023 to approximately $201,000 for the three months ended March 31, 2024. Other income, net decreased approximately $195,000 from a gain of approximately $285,000 for the three months ended March 31, 2023 to a gain of approximately $90,000 for the three months ended March 31, 2024. This decrease was primarily attributable to decreases of approximately $212,000 in research and development tax incentives related to our Australia subsidiary, increases in foreign currency losses of approximately $61,000, and increases in dividend income of approximately $80,000.

Current wording

Interest income increased approximately $71,000, or 60%, from approximately $118,000 for the three months ended June 30, 2023 to approximately $189,000 for the three months ended June 30, 2024. Other income, net decreased approximately $66,000 from a gain of approximately $326,000 for the three months ended June 30, 2023 to a gain of approximately $260,000 for the three months ended June 30, 2024. This decrease was primarily attributable to decreases of approximately $187,000 in research and development tax incentives related to our Australia subsidiary, offset in part by increases in unrealized gains on investments of approximately $55,000 and reductions in foreign currency losses of approximately $61,000.

Previous wording

For the three months ended March 31, 2024, net cash used in operating activities was approximately $3,069,000 compared to approximately $3,757,000 for the three months ended March 31, 2023. The reduction in cash used in operating activities was primarily due to increases in accounts payable and accrued expenses during the three months ended March 31, 2024, which reduced the use of cash.

Current wording

For the six months ended June 30, 2024, net cash used in operating activities was approximately $8,259,000 compared to approximately $7,349,000 for the six months ended June 30, 2023. The increase in net cash used in operating activities was primarily due to the increase in the net loss for the six months ended June 30, 2024, offset in part by increases in accounts payable and accrued expenses during the six months ended June 30, 2024, which reduced the use of cash.

Previous wording

For the three months ended March 31, 2024, net cash used in investing activities was approximately $556,000 compared to $961,000 of net cash used in investing activities for the three months ended March 31, 2023. The decrease in cash used in investing activities is primarily related to fewer net investments in marketable securities during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023.

Current wording

For the six months ended June 30, 2024, net cash used in investing activities was approximately $758,000 compared to $1,418,000 of net cash used in investing activities for the six months ended June 30, 2023. The decrease in cash used in investing activities is primarily related to a reduced level of net investments in marketable securities during the six months ended June 30, 2024, as compared to the six months ended June 30, 2023.

Previous wording

Net cash provided by financing activities was approximately $55,000 during the three months ended March 31, 2024, which is attributable to proceeds from warrant exercises. No cash was provided by or used in financing activities during the three months ended March 31, 2023.

Current wording

Net cash provided by financing activities was approximately $55,000 during the six months ended June 30, 2024, which is attributable to proceeds from warrant exercises. No cash was provided by or used in financing activities during the six months ended June 30, 2023.

Previous wording

As of March 31, 2024, we had total assets of approximately $39.7 million and working capital of approximately $35.5 million. As of March 31, 2024, our liquidity included approximately $38.4 million of cash, cash equivalents and marketable securities. We believe that our existing cash, cash equivalents, and marketable securities as of March 31, 2024, and our anticipated expenditures and capital commitments, will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date this quarterly report is filed. We expect to continue to incur significant and increasing operating losses at least for the next several years as we continue our clinical trials for LP-300, LP-184 and LP-284, advance our other drug candidates and programs, and seek potential future marketing approval for our drug candidates, which could be several years in the future, if at all. We do not expect to generate revenue, other than possible license and grant revenue, unless and until we successfully complete development and obtain regulatory approval for our therapeutic candidates. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our existing and planned clinical trials and our expenditures on other research and development activities.

Current wording

As of June 30, 2024, we had total assets of approximately $35.6 million and working capital of approximately $30.7 million. As of June 30, 2024, our liquidity included approximately $33.3 million of cash, cash equivalents and marketable securities. We believe that our existing cash, cash equivalents, and marketable securities as of June 30, 2024, and our anticipated expenditures and capital commitments, will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date this quarterly report is filed. We expect to continue to incur significant and increasing operating losses at least for the next several years as we continue our clinical trials for LP-300, LP-184 and LP-284, advance our other drug candidates and programs, and seek potential future marketing approval for our drug candidates, which could be several years in the future, if at all. We do not expect to generate revenue, other than possible license and grant revenue, unless and until we successfully complete development and obtain regulatory approval for our therapeutic candidates. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our existing and planned clinical trials and our expenditures on other research and development activities.

Previous wording

There have been no changes to our critical accounting estimates during the three months ended March 31, 2024.

Current wording

There have been no changes to our critical accounting estimates during the six months ended June 30, 2024.

Previous wording

We formed a wholly owned subsidiary, Lantern Pharma Australia Pty Ltd, in Australia in September 2021 and experienced foreign currency losses of approximately $99,000 and $38,000 for the three months ended March 31, 2024 and 2023, respectively, in connection with this subsidiary. We will remain subject to the risk of foreign currency losses in future periods, although we do not expect the impact of any foreign currency losses to be material. We do not participate in any foreign currency hedging activities, and we do not have any other derivative financial instruments.

Current wording

We formed a wholly owned subsidiary, Lantern Pharma Australia Pty Ltd, in Australia in September 2021 and experienced foreign currency losses of approximately $51,000 for each of the six months ended June 30, 2024 and 2023 in connection with this subsidiary. We will remain subject to the risk of foreign currency losses in future periods, although we do not expect the impact of any foreign currency losses to be material. We do not participate in any foreign currency hedging activities, and we do not have any other derivative financial instruments.

Previous wording

Inflation generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect on our results of operations during the periods presented. Inflation has increased substantially in recent periods and could have a greater impact on our future results of operations if it remains at current levels or continues to increase.

Current wording

Inflation generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect on our results of operations during the periods presented. Inflation has increased substantially in recent periods and could have a greater impact on our future results of operations if it remains at current levels or increases further.