About Us | ScientistLTRN Lantern Pharma Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
LP-300
Non-small cell lung cancer (NSCLC)
|
Phase 2
Phase 2
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Phase 2 trial planned for 3Q 2021.
|
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LP-100
Hormone-refractory prostate cancer (MHRPC)
|
Phase 2
Phase 2
|
Phase 2 trial ongoing.
|
Latest News
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DALLAS, July 29, 2021 /PRNewswire/ -- Lantern Pharma Inc. (NASDAQ:LTRN) ("Lantern"), a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("A.I.") platform to transform oncology drug discovery and development today announced financial results for the second quarter ended June 30, 2021.
"We are committed to bringing our pipeline of targeted cancer therapies to patients faster by utilizing our RADR® A.I. platform and making continual advances in our portfolio," stated Panna Sharma, President and CEO of Lantern Pharma. "This past quarter we made significant advances in our LP-184 program in pancreatic cancer and in validating the role this potent molecule can play in being synthetically lethal in cancers with DNA repair deficiencies. This opens up opportunities for LP-184 in several additional cancers, such as bladder and ovarian, and as a potential combination agent with existing PARP inhibitors."
"With the recently announced reacquisition of LP-100 earlier this week, we will use insights from the LP-100 trial and investigators to assess further enrollment of the Phase 2 trial in Denmark and initiation of other studies where LP-100 can play a role as a potential cancer therapy. We believe this molecule has the potential to address a market of nearly $200 million in the U.S. and approximately $700 million globally."
Lantern is developing four drug candidates and an ADC program across eight disclosed indications, including:
- LP-100 (Irofulven), in a Phase 2 trial for the treatment of metastatic castration resistant prostate cancer (mCRPC), which showed median overall survival (mOS) of 12.5 months in the initial 9 patients.
- LP-300, a small molecule drug-candidate that is preparing to enter a Phase 2 trial as a combination therapy in never-smokers with non-small cell lung cancer (NSCLC).
- LP-184, a small molecule DNA damaging candidate in preclinical development for genomically-defined pancreatic and bladder cancers, and potentially other cancers that overexpress PTGR1.
- LP-184, additionally in brain cancers such as: glioblastoma multiforme (GBM), and atypical teratoid rhabdoid tumors (ATRT) and other undisclosed brain tumors.
- LP-284, an alkylating agent that is preferentially active in hematologic cancers and works by blocking transcription of translocated fusion proteins required for survival of such cancers.
- LP-A18 - an antibody drug conjugate (ADC) program that is in late stage discovery to optimize conjugation among known and commercially available antibodies, selected based on insights from RADR, with LP-184 or similar high-potency small molecules.
Second Quarter 2021 Financial Highlights
- Balance Sheet: Cash, cash equivalents, and marketable securities were $79.6 million as of June 30, 2021, compared to $19.2 million as of December 31, 2020. The increase reflects $69.0 million of gross proceeds from our January 20, 2021 follow-on public offering.
- R&D Expenses: Research and development expenses were $1,164,892 for the quarter ended June 30, 2021, compared to $157,023 for the quarter ended June 30, 2020. The increase was primarily attributable to increases in manufacturing related expenses, research study expenses, research team expenses, and research and development related stock option compensation expense of $115,761 (a non-cash item) for the quarter ended June 30, 2021.
- G&A Expenses: General and administrative expenses were $1,314,201 for the quarter ended June 30, 2021, compared to $676,399 for the quarter ended June 30, 2020. The increase was primarily attributable to expenses associated with operating as a public company and general and administrative related stock option compensation expense of $129,923 (a non-cash item) for the quarter ended June 30, 2021.
- Net Loss: Net loss was $2,316,481 for the quarter ended June 30, 2021, or $0.21 per share, compared to a net loss of $833,422 for the quarter ended June 30, 2020, or $0.31 per share. The net loss for the quarter ended June 30, 2021 included $47,889 in interest income and $114,723 in other income, net, primarily attributable to a gain on loan forgiveness of Lantern's PPP loan. The net losses include non-cash expenses related to employee stock options of $245,684 for the quarter ended June 30, 2021.
Mr. Sharma continued, "We remain steadfast in building Lantern into a best-of-breed biopharmaceutical company that blends insights from our RADR® A.I. platform with the experience and expertise of our research team and a roster of collaborations with world-renowned cancer research institutions. Machine learning enabled identification and validation of molecular drivers of cancer provides the potential for more targeted and more effective oncology therapies. We are confident that our portfolio of genetically targeted oncology drug candidates can deliver significant enduring value for our shareholders."
Expected Upcoming Milestones
- Clinical trial site selection for LP-300 Phase 2 trial aimed at never-smokers with NSCLC.
- Data from first phase of the collaboration in GBM (Glioblastoma multiforme) with The Brain Cancer Program at Johns Hopkins University with LP-184.
- Preclinical data from ATRT (atypical teratoid rhabdoid tumors) studies -- an ultra rare brain cancer -- also in collaboration with Johns Hopkins University with LP-184.
- Additional details regarding the research collaboration in pancreatic cancer with Fox Chase Cancer Center, including data regarding efficacy in comparison with other targeted therapeutics.
- Additional detailed data from the existing Phase 2 clinical trial with LP-100 that showed a median overall survival of 12.5 months for the initial 9 metastatic, castration-resistant prostate cancer patients.
- Collaborations with leading research and academic centers and companies that advance our platform and our portfolio.
- Data on the initial targeted indications for LP-284.
- Details on the designs, efficacy and disease targets of the ADC program.
Conference Call
- Toll-free US and Canada: 800–791–4813 – conference ID# 20284
- International: 785–424–1102 – conference ID# 20284
- Replay Number: 1-800-839–5642, no passcode -- available through 11:59 pm ET on August 29, 2021.
Webcast
- Live webcast will be available at: Lantern Pharma 2Q21 Earnings Call Webcast
- The webcast will be archived on https://ir.lanternpharma.com through 11:59 pm ET on August 29, 2021.
About Lantern Pharma
Lantern Pharma (LTRN) is a clinical-stage oncology-focused biopharmaceutical company leveraging its proprietary RADR® A.I. platform and machine learning to discover biomarker signatures that identify patients most likely to respond to its pipeline of targeted therapeutics. Lantern is currently developing four drug candidates and an ADC program across eight 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 approach represents the potential to deliver best-in-class outcomes. More information is available at: www.lanternpharma.com and Twitter @lanternpharma.
Contact
Panna Sharma, CEO
[email protected]
(628)777-3339Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "objective," "aim," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the impact of the COVID-19 pandemic, (ii) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (iii) the risk that no drug product based on our proprietary RADR A.I. platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (iv) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 10, 2021. You may access our Annual Report on Form 10-K for the year ended December 31, 2020 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC's website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
Lantern Pharma Inc. and Subsidiary
Condensed Consolidated Balance Sheets
June 30,
December
31,2021
2020
(Unaudited)
CURRENT ASSETS
Cash and cash equivalents
$
61,354,117
$
19,229,232
Marketable securities
18,234,540
-
Prepaid expenses and other current assets
2,542,426
1,007,690
Total current assets
82,131,083
20,236,922
Property and equipment, net
30,598
21,507
Deferred offering costs
-
101,205
Operating lease right-of-use assets
252,503
-
Other assets
17,889
-
TOTAL ASSETS
$
82,432,073
$
20,359,634
CURRENT LIABILITIES
Accounts payable and accrued expenses
$
1,093,787
$
552,339
Insurance payable
1,448,419
-
Operating lease liabilities, current
145,898
-
Total current liabilities
2,688,104
552,339
Operating lease liabilities, net of current portion
130,705
-
PPP loan payable
-
108,500
TOTAL LIABILITIES
2,818,809
660,839
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Preferred Stock - Par Value (1,000,000 authorized at June 30, 2021 and December 31,
2020; $.0001 par value) (Zero shares issued and outstanding at June 30, 2021 and
December 31, 2020)-
-
Common Stock – Par Value (25,000,000 authorized at June 30, 2021 and December 31,
2020; $.0001 par value) (11,184,039 shares issued and outstanding at June 30, 2021;
6,220,927 shares issued and outstanding at December 31, 2020)1,118
622
Additional paid-in capital
97,088,382
32,358,068
Accumulated deficit
(17,428,671)
(12,659,895)
Accumulated other comprehensive loss
(47,565)
-
Total stockholders' equity
79,613,264
19,698,795
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$
82,432,073
$
20,359,634
Lantern Pharma Inc. and Subsidiary
Condensed Consolidated Statements of Operations (Unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Operating expenses:
General and administrative
1,314,201
676,399
2,487,459
1,016,571
Research and development
1,164,892
157,023
2,443,929
294,127
Total operating expenses
2,479,093
833,422
4,931,388
1,310,698
Loss from operations
(2,479,093)
(833,422)
(4,931,388)
(1,310,698)
Interest income
47,889
-
47,889
-
Other income, net
114,723
-
114,723
-
NET LOSS
$
(2,316,481)
$
(833,422)
$
(4,768,776)
$
(1,310,698)
Net loss per share of common shares, basic and diluted
$
(0.21)
$
(0.31)
$
(0.45)
$
(0.55)
Weighted-average number of common shares
outstanding, basic and diluted11,181,504
2,719,198
10,631,121
2,370,082
Lantern Pharma Inc. and Subsidiary
Condensed Consolidated Statements of Comprehensive Loss (Unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
NET LOSS
$
(2,316,481)
$
(833,422)
$
(4,768,776)
$
(1,310,698)
Other comprehensive loss, net of tax
Unrealized loss on available-for-sale securities, net of tax
(47,565)
-
(47,565)
-
Other comprehensive loss, net of tax
(47,565)
-
(47,565)
-
Comprehensive loss
$
(2,364,046)
$
(833,422)
$
(4,816,341)
$
(1,310,698)
View original content to download multimedia:https://www.prnewswire.com/news-releases/lantern-pharma-reports-second-quarter-2021-financial-results-and-operational-highlights-301344647.htmlSOURCE Lantern Pharma
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DALLAS, July 27, 2021 /PRNewswire/ -- Lantern Pharma (NASDAQ:LTRN), a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced it has entered into an Asset Purchase Agreement to reacquire global development and commercialization rights for Irofulven (LP-100) from Allarity, formerly known as Oncology Venture. This transaction includes global rights to the clinical stage drug candidate Irofulven (LP-100), as well as the developed clinical protocol for an intended study in bladder and prostate cancer patients who have a mutation in the ERCC2/3 genes. Lantern also received an exclusive license to use Allarity's companion diagnostic in future development and commercialization of LP-100. Lantern will assume full authority to manage and guide future clinical development and commercialization of the drug candidate.
"Based on the promising initial survival data, and the new observations on LP-100's efficacy in cancers with DNA repair deficiency, regaining the rights and future control of the program will increase Lantern's strategic flexibility regarding drug-development, and greatly increase the potential upside to Lantern from future successful development of LP-100," said Panna Sharma, President and CEO of Lantern Pharma. "This program is very synergistic with our other drug candidates that are also focused on DNA damage repair and the NER pathway. Most importantly, LP-100 has the potential to be an important compound — either as monotherapy or in combination — for several challenging cancers that are impacting patients globally. We are looking forward to advancing the LP-100 program using our data-driven and precision medicine approach."
In the current Phase 2 trial, being conducted in Denmark, 9 patients, out of a targeted enrollment of 27, have been treated based on meeting criteria established by Allarity's DRP® (Drug Response Predictor) companion diagnostic technology. The current Irofulven clinical trial seeks to evaluate the anti-tumor effect after treatment of Irofulven in combination with prednisolone in patients who progressed on androgen receptor (AR)-targeted therapy and docetaxel-pretreated metastatic castration-resistant prostate cancer patients. Results from the initial 9 patients have shown a median overall survival (mOS) of 12.5 months, which is substantially greater than other 4th line (and later) regimens of metastatic castration-resistant treatment that have generated mOS ranging from 7.1 to 9.9 months. Based on this improvement in overall survival, and other observations from discussions with study investigators, Lantern will be working with clinical trial investigators and sites to evaluate further enrollment. Lantern will also be considering other improvements, guided by data and publications, suggesting enhanced efficacy of LP-100 in tumors with mutations in certain DNA repair genes. Lantern believes that using DNA repair gene mutations or deficiency as an additional selection criteria has the potential to enhance the selection of patients that can respond to and benefit from LP-100 therapy and further improve mOS.
Analysts at GlobalData estimate that there were over 42,900 cases of metastatic castration-resistant prostate cancer in the US during 2020, and over 170,000 cases globally. Approximately 25-30% of these patients in the US and globally, need treatment options in the third-line setting, or later and have the potential for treatment with LP-100 once approved as a therapeutic in this setting. In addition, approximately 25-30% of all metastatic prostate cancers have been observed to have mutations in DNA repair genes in multiple meta-analysis of the disease.
According to Sharma, "Our goal is to build upon the existing trial in metastatic castration-resistant prostate cancer patients and evaluate additional launches in other cancers with mutations in ERCC2/3, BRCA, PTEN, ATM, and other DNA-repair pathway genes. Several studies have shown efficacy of LP-100 and LP-184 in these pathways, especially in prostate and bladder cancers. Having both of these drug candidates in our portfolio is synergistic and allows us to develop several options towards a potentially approved therapeutic in cancers with significant unmet need for tens of thousands of patients annually."
LP-100 was initially revitalized by Lantern and its founders using a genomic and data-driven approach to uncover those cancers that were most sensitive to LP-100, and then focusing on the genomic features of the prostate cancers that showed the most sensitivity to the compound. According to Sharma, "Bringing LP-100 back to Lantern is the best path for the future development of this drug candidate allowing for a hybrid approach that combines real-world patient genomics and data-driven drug development."
Under the terms of the Asset Purchase Agreement, Lantern will pay an initial upfront amount of US $1.0 million, and future escrow payments that have the potential to deliver an additional US $1.0 million to Allarity based on drug manufacturing and trial enrollment milestones within the next 24 months. Allarity is also eligible to receive up to US $16 million in additional milestone payments over the life of the program based on IP license milestones and regulatory filings and approvals in the US and EU, and low- to mid-single-digit royalties on future commercial net sales.
"We are looking forward to further developing and extending the potential of LP-100 for cancer patients, and this agreement allows us to provide additional focus and resources on defining this drug candidate's role in both prostate and other DNA repair deficient cancers. We are encouraged by the initial observations from the first 9 patients, and we believe these observations support further study of LP-100 in terms of the role it might play in the battle to extend survival in late stage prostate cancer patients," stated Panna Sharma, CEO of Lantern Pharma.
Contacts
Investor Relations
Panna Sharma, CEO
[email protected]
628-777-3339Public Relations
Nicholas Koulermos, Vice President
[email protected]
646-843-1812About Lantern Pharma
Lantern Pharma (LTRN) is a clinical-stage oncology-focused biopharmaceutical company leveraging its proprietary RADR® A.I. platform and machine learning 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 seven 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 approach represents the potential to deliver best-in-class outcomes. More information is available at: www.lanternpharma.com and Twitter @lanternpharma.Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. These forward-looking statements involve risks, uncertainties and other factors, many of which are outside of Lantern's control and which could cause actual results to differ materially from the results discussed in the forward-looking statements. These forward-looking statements include statements concerning Lantern's plans, objectives, goals, future events, performance and/or other information that is not historical information, including among other things, statements relating to: future events; strategic plans to develop and advance Irofulven (LP-100); potential future clinical testing and treatment indications for Irofulven (LP-100); and estimates regarding potential markets and potential market sizes. There are a number of important factors that could cause actual results to differ materially from those indicated by the forward-looking statements, such as (i) the impact of the COVID-19 pandemic, (ii) the risk that clinical testing and development of Irofulven (LP-100) may not be successful and may not yield meaningful results, (iii) the risk that Irofulven (LP-100) may not receive future regulatory marketing approval or otherwise become a commercial product, and (iv) those other factors set forth in the Risk Factors section in Lantern's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 10, 2021. You may access Lantern's Annual Report on Form 10-K for the year ended December 31, 2020 under the investor SEC filings tab of Lantern's website at www.lanternpharma.com or on the SEC's website at www.sec.gov. Given these risks and uncertainties, Lantern can give no assurances that such forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by such forward-looking statements will in fact occur, and investors are cautioned not to place undue reliance on these statements. All forward-looking statements in this press release represent the judgment of Lantern as of the date hereof, and, except as otherwise required by law, Lantern disclaims any obligation to update any forward-looking statements to conform the statement to actual results or changes in its expectations.
View original content to download multimedia:https://www.prnewswire.com/news-releases/lantern-pharma-reacquires-rights-to-phase-2-clinical-trial-in-metastatic-prostate-cancer-and-global-development--commercialization-of-irofulven-lp-100-from-allarity-therapeutics-as-301342014.htmlSOURCE Lantern Pharma
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DALLAS, July 22, 2021 /PRNewswire/ -- Lantern Pharma (NASDAQ:LTRN), a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("A.I.") platform to improve drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, announced today that it will host a conference call and live webcast on Thursday, July 29, 2021 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss financial and operating results for the second quarter ended June 30, 2021. The call will be led by Panna Sharma, President and Chief Executive Officer. He will be joined on the call by other members of the management team.
Conference Call
Toll-free US and Canada: 800–791–4813 – conference ID# 20284
International: 785–424–1102 – conference ID# 20284
Replay Number: 1-800-839–5642, no passcode. Available through 11:59 pm ET on August 29, 2021.Webcast
Live webcast will be available at: Lantern Pharma 2Q21 Earnings Call WebcastThe webcast will be archived on https://ir.lanternpharma.com through 11:59 pm ET on August 29, 2021.
About Lantern Pharma
Lantern Pharma (LTRN) is a clinical-stage oncology-focused biopharmaceutical company leveraging its proprietary RADR® A.I. platform and machine learning 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 seven 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 approach represents the potential to deliver best-in-class outcomes. More information is available at: www.lanternpharma.com and Twitter@lanternpharma.Contact
Panna Sharma, CEO
[email protected]
(628)777-3339Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "objective," "aim," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the impact of the COVID-19 pandemic, (ii) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (iii) the risk that no drug product based on our proprietary RADR A.I. platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (iv) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 10, 2021. You may access our Annual Report on Form 10-K for the year ended December 31, 2020 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC's website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
View original content to download multimedia:https://www.prnewswire.com/news-releases/lantern-pharma-to-host-second-quarter-2021-operating-and-financial-results-conference-call-on-thursday-july-29-2021-at-430-pm-et-301339870.htmlSOURCE Lantern Pharma
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DALLAS, July 20, 2021 /PRNewswire/ -- Lantern Pharma (NASDAQ:LTRN), a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, announced today positive new data from its ongoing pancreatic cancer collaboration with the Pancreatic Cancer Institute at Fox Chase Cancer Center. Preclinical data demonstrated that the drug candidate, LP-184, demonstrated significant and rapid pancreatic tumor shrinkage, by over 90%, in in-vivo mouse models in 8 weeks. In comparison, the tumors in the untreated mice grew by over eleven-fold in volume during the same 8 week period.
Additional positive data on the efficacy and potency of LP-184 was gathered from 6 pancreatic cancer cell lines, and an additional 5 patient-derived xenograft (PDX) ex-vivo tumor models. Significant reduction of cancer cells and cancer cell growth was observed across all pancreatic cancer cell lines and PDX models that were tested in the study with IC50 values being in the nanomolar range (45-270 nM). These data and observations are being prepared for peer-reviewed publications, manuscripts and scientific conferences. Data from this study will be used to power future insights and analysis provided by Lantern's A.I. platform, RADR® , in addition to further enhancing the signature of response for LP-184 in pancreatic cancers. Lantern believes this to be a significant positive advancement for LP-184 in targeted pancreatic cancers and plans to advance the collaboration with Fox Chase Cancer Center into the next phase.
CRISPR knockout data confirmed the importance of PTGR1 in LP-184 cytotoxicity in pancreatic cancer, and validates the RADR-generated hypothesis that PTGR1 plays the leading role in orchestrating responsiveness of tumors to LP-184. The research conducted at Fox Chase Cancer Center leveraged CRISPR editing to silence the gene PTGR1 in pancreatic cancer cells — this resulted in virtually no-response by the pancreatic cancer cells to the drug. Those pancreatic cancer cells with PTGR1 expression (untouched by gene-editing) had heightened response to LP-184 causing cell death and IC50 values in the sub-100nM range. Lantern believes that using a defined genetic signature for patient selection can enhance the likelihood of clinical trial success and focus future clinical trials on those patients that will benefit most from the therapy.
The research has been conducted in collaboration with Dr. Igor Astsaturov, an established, NCI funded, physician scientist and co-leader of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center. Results demonstrated that LP-184 significantly and rapidly shrunk pancreatic cancer xenografts in mice, and after treatment with once weekly dosing at 3 mg/kg for 8 weeks, no tumors were present in 1 of 4 treated mice and in 3 of 4 mice the average size of remaining tumors was approximately 7% of the original tumor and 146-fold smaller than the untreated tumors.
Additional research was conducted with Dr. Astsaturov to further confirm the increased sensitivity to LP-184 in tumors that had damage to DNA repair pathways. It was observed that pancreatic tumors that harbored genetic alternations in the following DNA repair pathways — NER (nucleotide excision repair) and HR (homologous recombination) — had 2-fold increased sensitivity to LP-184. This observed data has implications in increasing the potential number of pancreatic cancer patients that can benefit from LP-184, and also in confirming prior Lantern research focused on aiming this drug-candidate at other cancers that have DNA repair pathway mutations. These could be mutations or deficiencies in genes such as: BRCA1, BRCA2, ATM, ATR, ERCC2, ERCC3, ERCC4, ERCC5, ERCC6, FANCD2, RAD51 and PALB2.
"These data mechanistically validate LP-184's potential as a synthetic lethal agent in many HRD (homologous recombination deficient) and NERD (nucleotide excision repair deficient) cancers." stated Dr. Astsaturov. "As a result, these data may be highly supportive of a future role for LP-184 in a genetically-defined subset of pancreatic cancer."
Pancreatic cancer is an orphan disease and has a five-year survival rate of 7.9%. This means that only approximately 8 in 100 people will have survived for five years and beyond. The 10-year survival rate of the disease is 1%, meaning only approximately 1 in 100 people survive 10 years and beyond. Pancreatic cancer has among the lowest 5-year survival rate of any of the 22 common cancers. GLOBOCAN estimates that for pancreatic cancer there are approximately 490,000 thousand new cases of pancreatic cancer globally, with over 62,000 occurring in North America annually. Targeting a specific subset of pancreatic cancer patients that are genetically defined has the potential to increase beneficial therapeutic options for patients and may ultimately improve survival for those with this cancer.
"We are highly encouraged by the results of this preclinical research and look forward to reporting the full results at future scientific conferences and in publications," noted Dr. Kishor Bhatia, Lantern's Chief Scientific Officer. "The study observed the significant and targeted anti-tumor effects of LP-184, even in pancreatic cancers that were resistant to standard-of-care drugs. Moreover, we also validated through the elegant work done with Dr. Astsaturov's lab, by use of CRISPR-editing, that PTGR1 does directly link to the anti-tumor activity of LP-184. We expect that we will be able to exploit this biomarker mechanism in various tumors beyond pancreatic in the future."
Lantern believes that LP-184 acts by damaging DNA selectively in tumors that express high levels of the enzyme PTGR1 – which occurs in several solid tumors. Analysis with Lantern's data platform, RADR®, indicated that 35-40% of pancreatic cancer transcriptomes in clinical databases have elevated PTGR1 expression. Lantern has also begun discussions on the design of first-in-human clinical studies for LP-184 in collaboration with Dr. Igor Astsaturov and other key opinion leaders in the pancreatic cancer treatment landscape. Lantern plans on initiating IND (Investigational New Drug) application enabling animal studies later this year, and Phase 1 human trials following the filing of a future IND application.
Contacts:
Investor Relations
Panna Sharma, CEO
[email protected]
628-777-3339Public Relations
Nicholas Koulermos, Vice President
[email protected]
646-843-1812About Lantern Pharma
Lantern Pharma (LTRN) is a clinical-stage oncology-focused biopharmaceutical company leveraging its proprietary RADR® A.I. platform and machine learning 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 seven 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 approach represents the potential to deliver best-in-class outcomes. More information is available at: www.lanternpharma.com and Twitter @lanternpharma.Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the impact of the COVID-19 pandemic, (ii) the risk that our research and the research of our collaborators in the area of pancreatic cancer may not be successful; (iii) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates; (iv) the risk that no drug product based on our proprietary RADR A.I. platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (v) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 10, 2021. You may access our Annual Report on Form 10-K for the year ended December 31, 2020 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC's website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
View original content to download multimedia:https://www.prnewswire.com/news-releases/lantern-pharma-announces-significant-positive-preclinical-data-in-pancreatic-cancer-with-drug-candidate-lp-184-301337294.htmlSOURCE Lantern Pharma
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DALLAS, May 3, 2021 /PRNewswire/ -- Lantern Pharma Inc. (NASDAQ:LTRN), a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("A.I.") platform to transform oncology drug discovery and development today announced financial results for the first quarter ended March 31, 2021.
"We are very pleased with our continued rapid progress in expanding and advancing our pipeline of targeted cancer drug candidates and are on pace to launch the Phase 2 trial of LP-300 in non-small cell lung cancer among non-smokers in the third quarter of this year," stated Panna Sharma, President and CEO of Lantern Pharma. "During the first quarter, we dramatically accelerated the pace with which we gather, curate, tag and assemble biologically relevant data for our RADR® A.I. platform. Our RADR® A.I. platform now exceeds 4.6 billion datapoints, representing a nearly 16-fold increase in the number of datapoints since our IPO in June 2020. RADR® grew by approximately 1 billion datapoints per month during the first quarter of 2021. The size and scope of our RADR® A.I. platform is opening up new insights and areas of opportunity for the discovery of additional indications for our existing drug candidates, as well as the identification of entirely new drug candidates and new therapeutic indications for existing molecules in the fight against cancer."
"Perhaps most exciting, as our RADR® A.I. platform grows, potential partnerships with biopharma companies are now even more clearly in our sights," continued Sharma. "Earlier today, we announced that we have entered into an equity-based collaboration with Actuate Therapeutics to apply the remarkable power of RADR® to better understand the mechanism of action of Actuate's 9-ING-41 drug candidate and utilize these insights to advance a biomarker signature of response and a biomarker guided development strategy. We are excited about the opportunity to continue to build additional value-driven partnerships in the quarters ahead."
The collaboration will focus on leveraging the RADR® machine learning technology, large-scale oncology datasets, and the A.I. platform to accelerate key aspects of Actuate's 9-ING-41 drug candidate, a best-in-class GSK-3β inhibitor in active development in multiple Phase 2 clinical trials, including for pancreatic cancer. The collaboration is expected to start immediately and will potentially generate novel intellectual property that will be jointly owned by the companies. Lantern will receive upfront equity in Actuate Therapeutics subject to meeting certain conditions of the collaboration, as well as development milestones in the form of additional equity if results from the collaboration are utilized in future development efforts.
Lantern is developing four drug candidates and an ADC program across seven disclosed targets, including:
- LP-100 (Irofulven), in a Phase 2 trial for the treatment of metastatic castration resistant prostate cancer (mCRPC) which is out-licensed to Allarity Therapeutics.
- LP-300, a small molecule candidate that is preparing to enter a Phase 2 trial as a combination therapy in non-smokers with Non-Small Cell Lung Cancer (NSCLC).
- LP-184, a small molecule DNA damaging candidate anticipated to enter clinical development in 1H'22, with opportunities in several genomically-defined cancers, including: prostate, pancreatic, glioblastoma multiforme (GBM), atypical teratoid rhabdoid tumors (ATRT) and potentially additional tumors defined by the overexpression of PTGR1.
- LP-284, an alkylating agent in the research optimization stage, that appears to be preferentially active in certain hematologic cancers.
- Antibody Drug Conjugate (ADC) program leveraging RADR® A.I. to identify targeted or therapeutic antibodies and aimed at utilizing a unique library of linkers to conjugate with LP-184 and other compounds.
First Quarter 2021 Financial Highlights
- Cash Position: Cash and cash equivalents were $81.4 million as of March 31, 2021 compared to $19.2 million as of December 31, 2020. The increase in cash and cash equivalents reflects the proceeds from our January 20, 2021 follow-on public offering with gross proceeds of $69.0 million.
- R&D Expenses: Research and development expenses were $1,279,037 for the quarter ended March 31, 2021, compared to $137,104 for the quarter ended March 31, 2020. The increase was primarily attributable to increases in research studies, expansion of the company's research team, and research and development related stock option compensation expense of approximately $116,000 (a non-cash item) for the quarter ended March 31, 2021.
- G&A Expenses: General and administrative expenses were $1,173,258 for the quarter ended March 31, 2021, compared to $340,172 for the quarter ended March 31, 2020. The increase was primarily attributable to expenses associated with operating as a public company and general and administrative related stock option compensation expense of approximately $130,000 (a non-cash item) for the quarter ended March 31, 2021.
- Net Loss: Net losses were $2,452,295 for the quarter ended March 31, 2021, or $0.24 per share, compared to a net loss of $477,276 for the quarter ended March 31, 2020, or $0.24 per share. The net loss includes non-cash expenses related to employee stock options of approximately $246,000 for the quarter ended March 31, 2021.
Mr. Sharma concluded, "We will continue to aggressively advance our portfolio, both clinically and in new preclinical indications, and continue to leverage our A.I. platform to uncover new rescue or repurposing opportunities on our own or with partners. Our team is committed to building Lantern into a best-of-breed biopharma company that transforms the cost, pace and risk of oncology drug development by leveraging insight from our RADR® A.I. platform with the experience and expertise of our cancer-focused research team and a roster of collaborations with world-renowned cancer research institutions. Our financial position has never been stronger and our portfolio of targeted oncology drug candidates is positioned to deliver significant ongoing value for shareholders."
Conference Call
Lantern will host a conference call and webcast today, Monday, May 3, at 4:30 p.m. ET.
Toll-free US and Canada: 800–791–4813 – conference ID 97381
US and Canada callers one touch dial: +1.800.791.4813,,97381#
International: 785–424–1102 – conference ID 97381
Replay Number: 1-800-839–8389, no passcode. Available through 11:59 pm ET on June 3, 2021.Webcast
Live webcast will be available at: https://www.webcaster4.com/Webcast/Page/2460/41104
The webcast will be archived on https://ir.lanternpharma.com through 11:59 pm ET on June 3, 2021.Contact
Marek Ciszewski, JD
Director, Investor Relations
628-777-3167
[email protected]About Lantern Pharma
Lantern Pharma (LTRN) is a clinical-stage oncology-focused biopharmaceutical company leveraging its proprietary RADR® A.I. platform and machine learning 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 seven 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 approach represents the potential to deliver best-in-class outcomes. More information is available at: www.lanternpharma.com and Twitter @lanternpharma.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "objective," "aim," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the impact of the COVID-19 pandemic, (ii) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates; (iii) the risk that no drug product based on our proprietary RADR A.I. platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (iv) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 10, 2021. You may access our Annual Report on Form 10-K for the year ended December 31, 2020 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC's website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
Lantern Pharma Inc. and Subsidiary
Condensed Consolidated Balance Sheets
March 31,
December 31,
2021
2020
(Unaudited)
CURRENT ASSETS
Cash
$
81,373,725
$
19,229,232
Prepaid expenses and other current assets
1,110,770
1,007,690
Total current assets
82,484,495
20,236,922
Property and equipment, net
20,164
21,507
Deferred offering costs
-
101,205
TOTAL ASSETS
$
82,504,659
$
20,359,634
CURRENT LIABILITIES
Accounts payable and accrued expenses
$
664,533
$
552,339
Total current liabilities
664,533
552,339
PPP loan payable
108,500
108,500
TOTAL LIABILITIES
773,033
660,839
COMMITMENTS AND CONTINGENCIES (NOTE 4)
STOCKHOLDERS' EQUITY
Preferred Stock - Par Value (1,000,000 authorized at March 31, 2021 and December 31, 2020; $.0001 par value) (Zero shares issued and outstanding at March 31, 2021 and December 31, 2020)
-
-
Common Stock – Par Value (25,000,000 authorized at March 31, 2021 and December 31, 2020; $.0001 par value) (11,181,447 shares issued and outstanding at March 31, 2021; 6,220,927 shares issued and outstanding at December 31, 2020)
1,118
622
Additional paid-in capital
96,842,698
32,358,068
Accumulated deficit
(15,112,190)
(12,659,895)
Total stockholders' equity
81,731,626
19,698,795
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$
82,504,659
$
20,359,634
Lantern Pharma Inc. and Subsidiary
Condensed Consolidated Statements of Operations (Unaudited)
Three Months Ended
March 31,2021
2020
Operating expenses:
General and administrative
1,173,258
340,172
Research and development
1,279,037
137,104
Total operating expenses
2,452,295
477,276
NET LOSS
$
(2,452,295)
$
(477,276)
Net loss per share of common shares, basic and diluted
$
(0.24)
$
(0.24)
Weighted-average number of common shares outstanding, basic and diluted
10,074,623
2,020,966
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