On March 10, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the fourth quarter and year ended December 31, 2021 and provided recent corporate updates (Press release, Galera Therapeutics, MAR 10, 2022, View Source [SID1234609899]).

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"In 2021, we were pleased to report positive data from our lead program evaluating avasopasem for the treatment of severe oral mucositis, a radiotherapy-induced toxicity, in patients with head and neck cancer," said Mel Sorensen, M.D., Galera’s President and CEO. "The Phase 3 ROMAN trial demonstrated a statistically significant reduction in the incidence of SOM, the primary endpoint, and in the number of days patients experienced SOM. This data is in line with the topline results observed in the Phase 2a EUSOM trial and our previously completed randomized Phase 2b trial, reinforcing avasopasem’s potentially transformative clinical benefit for patients undergoing radiotherapy for head and neck cancer. With this robust package of data in hand, we are preparing to meet with the FDA to discuss the potential NDA submission. Concurrently, we remain on track to report data from our Phase 2a AESOP trial evaluating avasopasem in esophagitis in the first half of this year."

Dr. Sorensen continued: "We also continue to progress our Phase 1/2 GRECO-1 and Phase 2b GRECO-2 clinical trials evaluating our second product candidate, rucosopasem, in increasing the anti-cancer efficacy of higher daily doses of radiotherapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer, respectively. We look forward to reporting initial data from our GRECO-1 trial in the first half of this year."

Recent Corporate Updates

Radiotherapy-Induced Toxicity Programs:

Severe Oral Mucositis (SOM)

On December 14, 2021, the Company announced corrected topline efficacy results from the Phase 3 ROMAN trial of avasopasem for the reduction of SOM in patients with locally advanced head and neck cancer (HNC). The Company had previously announced topline results from the ROMAN trial on October 19, 2021. Upon further analysis following the October announcement, an error by the contract research organization was identified in the statistical program. Correction of this error resulted in improved p-values for the primary and secondary endpoints. The corrected results demonstrated efficacy across multiple SOM endpoints with a statistically significant reduction on the primary endpoint of incidence of SOM and the secondary endpoint of number of days of SOM, more than halving the median number of days a patient experienced SOM. Avasopasem appeared to be generally well tolerated compared to placebo. The Company announced that it plans to meet with the U.S. Food and Drug Administration (FDA) in 2022 to discuss a potential New Drug Application (NDA) submission.
On December 14, 2021, the Company also reported topline data from the Phase 2a EUSOM multicenter trial of avasopasem in Europe in patients with HNC undergoing standard-of-care radiotherapy. Avasopasem appeared to be generally well tolerated and the incidence and number of days of SOM was in line with the avasopasem data reported in the Phase 3 ROMAN trial.
Esophagitis

The Company expects to report topline data from the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer in the first half of 2022.
Anti-Cancer Programs:

Locally Advanced Pancreatic Cancer (LAPC)

Enrollment is ongoing in the Phase 2b, 160-patient randomized, multicenter, placebo-controlled GRECO-2 trial of rucosopasem, Galera’s second dismutase mimetic product candidate, in combination with stereotactic body radiation therapy (SBRT) in patients with LAPC. The primary endpoint of the trial is overall survival.
Non-Small Cell Lung Cancer (NSCLC)

Enrollment is ongoing in the Phase 1/2 GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. The Company expects to report initial data from this trial in the first half of 2022.
Fourth Quarter 2021 Financial Highlights

Research and development expenses were $9.2 million in the fourth quarter of 2021, compared to $14.6 million for the same period in 2020. The decrease was primarily attributable to a decrease in avasopasem development costs, partially offset by an increase in rucosopasem development costs.
General and administrative expenses were $5.3 million in the fourth quarter of 2021, compared to $4.3 million for the same period in 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, and increased insurance expense and professional fees.
Galera reported a net loss of $(16.8) million, or $(0.64) per share, for the fourth quarter of 2021, compared to a net loss of $(20.1) million, or $(0.80) per share, for the same period in 2020.
As of December 31, 2021, Galera had cash, cash equivalents and short-term investments of $71.2 million. Galera expects that its existing cash, cash equivalents and short-term investments will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2023.
Full Year 2021 Financial Highlights

Research and development expenses were $52.4 million for the year ended December 31, 2021, compared to $54.8 million for the year ended December 31, 2020. The decrease was primarily attributable to a decrease in avasopasem development costs, partially offset by an increase in rucosopasem development costs.
General and administrative expenses were $21.0 million for the year ended December 31, 2021, compared to $15.7 million for the year ended December 31, 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, increased expenses related to preparation for potential commercialization of avasopasem, and increased insurance expense and professional fees.
Galera reported a net loss of $(80.5) million, or $(3.12) per share, for the year ended December 31, 2021, compared to a net loss of $(74.2) million, or $(2.98) per share, for the year ended December 31, 2020.

On March 10, 2022 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, reported that Mina Sooch, MBA, Founder and CEO will present a corporate overview at the Oppenheimer 32nd Annual Healthcare Conference on Wednesday, March 16 at 8:00-8:30 AM EDT (Press release, Ocuphire Pharma, MAR 10, 2022, View Source [SID1234609916]).

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Oppenheimer 32nd Annual Healthcare Conference – March 15-17, 2022

Title: Ocuphire Pharma (OCUP) Company Presentation
Date: Wednesday, March 16, 2022
Time: 8:00 AM EDT
Presenter: Mina Sooch, CEO
Webcast Link: Register here
If you are interested in arranging a 1X1 meeting request or listening live or to a replay of the company presentation, please contact your bank conference representative or [email protected]. To access the archived recording for replay, please see the Investors and Events section of Ocuphire’s corporate website.

On March 10, 2022 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported its financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, Regulus, MAR 10, 2022, View Source [SID1234609932]).

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"Last year was a transformational year for Regulus with the accomplishments in our ADPKD program including clinical validation of the target and the prioritization and advancement of our next generation compound RGLS8429," commented Jay Hagan, CEO of Regulus Therapeutics. "We are on track with an IND filing and initiation of our Phase 1 clinical study and with the recent equity financing we believe the Company is poised and capitalized to deliver on upcoming milestones."

Program Updates

RGLS8429 for ADPKD: In January 2022, the Company announced the successful completion of a pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA). The FDA provided overall agreement with the trial design and length of the Phase 1 study. Based on this feedback, the company is on track to submit an IND application in the second quarter of 2022 to obtain clearance for the initiation of the Phase 1 clinical trial. The Company anticipates reporting top-line data from the healthy volunteer portion of the study in the second half of 2022, and top-line biomarker data in the first cohort of RGLS8429-treated patients with ADPKD in the first half of 2023.

Lademirsen (RG-012) for Alport syndrome: In February 2022, the Company announced completion of enrollment in the Phase 2 HERA clinical study evaluating lademirsen for the treatment of adult patients with Alport Syndrome under the Company’s Collaboration and License Agreement with Sanofi. Final data is expected in the first half of 2023 and if successful could provide further validation of the Company’s platform technology designed to address genetic kidney diseases and earn the Company a $25 million milestone, furthering the cash runway into 2024.

Corporate Highlights

Closed $34.6 Million Private Placement: In November 2021, the Company announced the closing of a private placement of equity. The financing was led by the Federated Hermes Kaufmann Funds and New Enterprise Associates (NEA), with participation from other new and existing investors. The Company received gross proceeds of approximately $34.6 million from the sale of 58,923,352 shares of the Company’s common stock ("Common Stock") at a purchase price of $0.36 per share. In addition, the Company sold 3,725,720 shares of non-voting Class A-4 convertible preferred stock, in lieu of shares of Common Stock, at a price of $3.60 per share. Each share of non-voting Class A-4 convertible preferred stock is convertible into 10 shares of Common Stock, subject to certain beneficial ownership conversion limitations. Net proceeds from the transaction will be used for non-clinical and clinical development activities for the Company’s product candidates and general corporate purposes. SVB Leerink acted as the lead placement agent for the financing and H.C. Wainwright and Co. acted as co-placement agent.

Expanded Team: In December 2021, the Company announced the appointment of Mohammad Ahmadian, Ph.D., as Vice President, Chemistry and Pharmaceutical Development. Dr. Ahmadian has worked for various life sciences companies in research and managerial capacities. Most recently, he was Vice President & Resident Director of Kinovate Life Sciences, Inc.

Financial Results

Cash Position: As of December 31, 2021, Regulus had $60.4 million in cash and cash equivalents.

Research and Development (R&D) Expenses: Research and development expenses were $4.4 million and $17.8 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $4.0 million and $15.3 million for the same periods in 2020, respectively. These amounts reflect internal and external costs associated with advancing our clinical and preclinical pipeline.

General and Administrative (G&A) Expenses: General and administrative expenses were $2.6 million and $10.0 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $2.1 million and $8.8 million for the same periods in 2020, respectively. These amounts reflect personnel-related and ongoing general business operating costs.

Net Loss: Net loss was $7.1 million, or $0.07 per share (basic and diluted), and $27.8 million, or $0.32 per share (basic and diluted), for the fourth quarter and year ended December 31, 2021, respectively, compared to $1.3 million, or $0.03 per share (basic and diluted), and $15.7 million, or $0.45 per share (basic and diluted), respectively, for the same periods in 2020.

Conference Call and Webcast Information:
The Company will host a conference call and live audio webcast today at 5:00 p.m. ET to discuss its fourth quarter and year end 2021 financial results and corporate update. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 3786683. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode ID 3786683. The webcast and telephone replay will be archived on the Company’s website at www.regulusrx.com following the call.

About ADPKD

ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of end-stage renal disease. The disease is characterized by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50% of ADPKD patients by age 60.

About RGLS8429

RGLS8429 is a novel, next generation oligonucleotide designed to inhibit miR-17 and to preferentially target the kidney. Administration of RGLS8429 has shown robust data in preclinical models, where clear improvements in kidney function, size, and other measures of disease severity, as well as a superior pharmacologic profile have been demonstrated. Regulus has nominated RGLS8429 as a clinical candidate for the treatment of ADPKD.

On March 10, 2022 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, reported its financial results for the fourth quarter and full year ended December 31, 2021 and provided an update on key strategic initiatives (Press release, BioXcel Therapeutics, MAR 10, 2022, View Source [SID1234609868]).

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"2021 was marked by significant achievement across the business, most notably with the NDA submission for BXCL501, which concluded an unprecedented, less than three-year journey from first-in-human trials to regulatory submission," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "As we near potential approval, we remain focused on executing our launch readiness plan. Matt Wiley, who recently joined as our Chief Commercial Officer, has, and will continue to play a pivotal role in developing our commercial and market access strategy and building out our field sales organization. In parallel, we continued to advance our ‘land and expand’ strategy by furthering our Alzheimer’s disease and MDD programs, both important components of our five-year vision to become the leading AI-enabled neuroscience Company."

Dr. Mehta added, "Our oncology franchise further progressed with encouraging composite response rates for BXCL701 in combination with KEYTRUDA for mCRPC patients with SCNC and adenocarcinoma phenotypes, both aggressive tumors with very few treatment options. We continue to develop BXCL701’s potential to convert cold tumors to hot as a novel systemic innate immune activator."

Company Highlights

Neuroscience Franchise

BXCL501 is an investigational, proprietary, orally dissolving, thin film formulation of the adrenergic receptor agonist dexmedetomidine for the treatment of agitation associated with neuropsychiatric disorders. BXCL501 has received U.S. Food & Drug Administration (FDA) Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and FDA Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders I and Il, and dementia.

BXCL501 for the Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorders: The Company is gearing up to launch BXCL501 in the U.S. pending FDA approval by the April 5, 2022 PDUFA action date. This is a large addressable market, with over 7 million people in the U.S. diagnosed with schizophrenia or bipolar disorders1-3, totaling approximately 25 million annual agitation episodes.3

Data Published in Journal of the American Medical Association (JAMA) from SERENITY II Pivotal Phase 3 Trial Evaluating BXCL501 in Bipolar Disorders: Results demonstrate BXCL501 as a potential treatment for the millions of patients experiencing agitation, a difficult-to-manage symptom associated with many neuropsychiatric conditions.
Indication Expansion

BXCL501 for Acute Treatment of Agitation in Patients with Alzheimer’s Disease: Initiated pivotal Phase 3 program in Q4 2021 following alignment with FDA on key trial design features. Alzheimer’s disease is the most prevalent type of dementia in the U.S. and is expected to approximately double from 5.8 million patients in 2020 to 11.8 million patients by 2040.4

BXCL501 for Major Depressive Disorder (MDD): Submitted an Investigational New Drug (IND) application to evaluate BXCL501 as an adjunct treatment for MDD, the most common type of depression in the United States with approximately 27 million cases a year.5 There are over 300 million antidepressant prescriptions filled annually, with limitations of current treatment including slow onset of action and incomplete response.6
Geographic Expansion

International Growth: The Company expects to submit a Marketing Authorization Application to the European Medicines Agency (EMA) for BXCL501 in 1H 2022.
AI-driven Drug Discovery & Development

The Company continues its innovative approach to R&D by leveraging its proprietary artificial intelligence platform to expand its current neuroscience portfolio, including identification of the Company’s newest product candidate, BXCL502. The Company initiated formulation for this new product candidate for chronic treatment of agitation in dementia patients. BXCL502 is designed to be a potent and selective antagonist for a GPCR target affecting serotonergic signaling in the cerebral cortex.
BXCL501 Commercial Readiness Progress

Expanded Commercial Organization: Hired Chief Commercial Officer Matt Wiley to develop integrated commercial strategy for potential BXCL501 approval and beyond, and continue the buildout of the Company’s national sales force.

Medical Science Liaison and Medical Managed Care Teams Fully Deployed: Continued engagement with health care professionals (HCPs) and payers to provide key insights and support potential BXCL501 commercial launch, including planned participation at:
Academy of Managed Care Pharmacy annual meeting in March 2022
International Society of Pharmacoeconomics and Outcomes Research conference in May 2022
Immuno-Oncology Franchise

BXCL701 is an investigational, orally administered, systemic innate immune activator in development for treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.

Metastatic Castration-Resistant Prostate Cancer (mCRPC) Program: Presented positive data from Phase 2 trial of BXCL701 in aggressive forms of prostate cancer at 2022 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February. The presentations showed that BXCL701 plus KEYTRUDA (pembrolizumab) demonstrated encouraging composite response rates in patients with either adenocarcinoma (21% response rate) or SCNC (33% response rate) phenotype, supporting further evaluation of BXCL701’s potential to extend checkpoint inhibitor therapy into cold tumor settings.

Solid Tumors Program (Checkpoint Naïve and Refractory): Additional efficacy data from MD Anderson-led open-label Phase 2 basket trial of BXCL701 and KEYTRUDA expected in 2H 2022.
Fourth Quarter and Full Year 2021 Financial Results

Research and Development Expenses: Research and development expenses were $12.5 million for the fourth quarter of 2021, compared to $11.4 million for the same period in 2020. The increased expenses were primarily attributable to increased headcount and related costs during the three-month period of 2021.

Research and development expenses were $52.7 million for the full year 2021, as compared to $58.0 million for the same period in 2020. The decrease for the year ended December 31, 2021 was primarily attributable to decreased clinical trial expenses related to BXCL501, partially offset by increased costs related to BXCL701 clinical trials.

General and Administrative Expenses: General and administrative expenses were $13.6 million for the fourth quarter of 2021, as compared to $9.7 million for the same period in 2020. The increase was primarily due to increased headcount and related costs, including higher stock-based compensation, increased marketing and commercial costs related to the potential launch of BXCL501 in the U.S., as well as increased legal and professional fees, and insurance costs.

General and administrative expenses were $54.2 million for the full year 2021, as compared to $24.3 million for the same period in 2020. The increase for the year ended December 31, 2021 was primarily attributable to increased headcount and associated costs, including non-cash stock-based compensation. The Company also incurred significant commercial costs in preparation for a potential U.S. launch of BXCL501.

Net Loss: BioXcel Therapeutics reported a net loss of $26.1 million for the fourth quarter of 2021, compared to a net loss of $21.1 million for the same period in 2020. For the full year, BioXcel reported a net loss of $106.9 million, compared to a net loss of $82.2 million for the same period in 2020.

As of December 31, 2021, cash and cash equivalents totaled approximately $233.0 million.

Conference Call

BioXcel Therapeutics will host a conference call and webcast March 10, 2022 at 8:30 a.m. ET, to discuss its fourth quarter and full year 2021 financial results and provide an update on recent operational highlights. To access the call, please dial 877-407-5795 (domestic) and 201-689-8722 (international). A live webcast of the call will be available on the Investors section of the BioXcel website, www.bioxceltherapeutics.com, and a replay of the call will be available through at least April 10, 2022.

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the "Email Alerts" option under the News/Events menu of the Investors & Media section of its website.

On March 10, 2022 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, reported financial results and operational highlights for the fourth quarter and fiscal year ended December 31, 2021 (Press release, Lantern Pharma, MAR 10, 2022, View Source/news/press-releases/detail/82/lantern-pharma-reports-fourth-quarter-and-fiscal-year-2021" target="_blank" title="View Source/news/press-releases/detail/82/lantern-pharma-reports-fourth-quarter-and-fiscal-year-2021" rel="nofollow">View Source [SID1234609884]).

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"2021 was a transformational year for Lantern Pharma as we strengthened our financial position, significantly expanded our A.I. platform, and achieved multiple key clinical milestones that further advanced our oncology portfolio," stated Panna Sharma, President and CEO of Lantern Pharma. "Our proprietary RADR A.I. platform surpassed 18 billion data points and grew over 1,000% in 2021, significantly exceeding our growth expectations. This further development of RADR is enabling an acceleration of the insights that are powering development decisions for our drug candidates and also support evaluation of drugs and drug candidates of other biopharma companies."

"Across our entire portfolio of late-stage drug programs, we are progressing towards launching Phase 1 and Phase 2 clinical trials in 2022, including the Phase 2 trial for LP-300, The Harmonicä Clinical Trial, for advanced non-small cell lung cancer in never smokers. Our dedicated team is focused on completing the requirements and details to launch these trials including IND-enabling studies and submissions, clinical site selection, and patient enrollment," stated Sharma.

Operational Highlights:

RADR Platform Growth and Development

Surpassed 18 billion data points for RADR platform, a significant growth of more than 1,000% from year-end 2020; forecasting to reach more than 25 billion data points by year-end 2022.
The ongoing growth of RADR data points is expected to drive continual improvement in Lantern’s ability to rapidly identify new indications, combination therapies, and mechanisms of action for the Company’s drug candidates.
Expanding RADR’s capabilities with a focus on increasing the number of machine learning algorithms and self-learning algorithms.
The Company expects to continue to expand its focus on building biopharma collaborations to utilize and expand on the growth of RADR.
Lantern’s Portfolio of Targeted Therapies
Lantern Pharma is currently developing four drug candidates and an Antibody-Drug Conjugate (ADC) program across eight disclosed tumor targets, and several undisclosed targets. Lantern’s portfolio currently includes:

LP-100 – is in a Phase 2 trial for the treatment of metastatic castration resistant prostate cancer (mCRPC). We are evaluating possibilities for further enrollment in the current Phase II trial as well as other potential clinical development opportunities. Lantern reacquired global rights to LP-100 in July 2021.
LP-300 – is preparing to enter a Phase 2 clinical trial, the Harmonicä Clinical Trial, during 2022. The Harmonicä trial will be a 90 patient, two-arm, open label clinical trial focused on never smoker patients with relapsed primary adenocarcinoma of the lung, a type of NSCLC.
LP-184 – is in preparation for potentially multiple Phase 1 clinical trial launches for genomically defined cancers, including pancreatic, glioblastoma multiforme (GBM), bladder and atypical teratoid rhabdoid tumors (ATRT).
The FDA granted LP-184 Orphan Drug Designations for the treatment of pancreatic cancer, GBM, and ATRT and a Rare Pediatric Disease Designation for treatment of ATRT. These designations will assist the advancement of LP-184 towards clinical studies. Under the Rare Pediatric Disease Priority Review Voucher Program companies may be eligible to receive a priority review voucher if the product satisfies certain conditions, including receipt of regulatory marketing approval following required clinical testing. Vouchers may be sold or transferred to another sponsor, and past transfers of vouchers have occurred at average prices of more than $100 million.

LP-284 – is in preclinical development and has demonstrated potency at low nanomolar levels in hematological cancer cell lines, including lymphoma, multiple myeloma, and leukemia. LP-284’s indications in hematological cancers are distinct from the indications targeted by LP-184 and were generated with the assistance of RADR insights.
Antibody Drug Conjugate (ADC) Program – we have selected and ranked multiple targeting antibodies of interest with potential to be linked to selected cytotoxic payloads. We are currently evaluating various cytotoxic agents and classes of agents to be used as ADC payloads.
World-Class Scientific Collaborations

Expanded collaboration with the National Cancer Institute to accelerate the path to first in-human clinical trials for drug candidates LP-184 and LP-284.
Entered collaboration with The Greehey Children’s Cancer Research Institute (GCCRI) at University of Texas Health Science Center-San Antonio to expand Lantern’s drug portfolio research into several additional pediatric cancers.
Continued GBM & brain cancer collaboration with Johns Hopkins & Kennedy Krieger Institute to develop Phase 1 clinical design and further validate LP-184’s ability to works independently of MGMT (a DNA repair enzyme) status.
Expanded collaboration with Fox Chase Cancer Center in pancreatic cancers with a focus on clinical design and strategy for LP-184.
Launched a research collaboration with The Danish Cancer Society Research Center to support development of drug candidates LP-100 and LP-184 in 9 solid tumor types that have a known deficiency in DNA repair mechanisms. LP-100 and LP-184 have both been shown to have a synthetically lethal impact on tumors deficient in DNA repair mechanisms.
Publications and Presentations

Published two scientific articles in Oncotarget and BMC Bioinformatics highlighting the effectiveness of Lantern’s drug candidate LP-184 in potential tumor indications.
Presented positive preclinical data on the efficacy of LP-284 in hematologic cancers at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Preclinical data supporting the effectiveness of LP-184 in select pancreatic cancers was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Special Conference.
The effectiveness of LP-184 in multiple in vitro and in vivo Glioblastoma models was presented at the Society for Neuro-Oncology (SNO) 2021 Annual Meeting.
On World Pancreatic Cancer Day, Lantern hosted a virtual KOL webinar on the potential of drug candidate LP-184 for pancreatic cancer.
Additional Highlights

Strengthened intellectual property estate with 12 new patent applications, with the current total IP estate at over 80 active patents and patent applications across 14 patent families.
Completed strategic hires to expand and strengthen Lantern’s data science, research, management, and communications teams.
Financial Highlights:

Raised gross proceeds of $69 million USD through January 2021 public offering and full exercise of underwriter’s over-allotment option.
Capital raised extends cash runway into 2025, allowing the Company to focus on efficiently developing its portfolio of promising oncology therapeutics.
Authorized a share repurchase program to acquire up to $7 million of the Company’s common stock. Repurchases of shares of common stock pursuant to the repurchase program amounted to $0.9 million during the quarter and year ended December 31, 2021 and an additional $2.2 million of repurchases from January 1, 2022 through March 1, 2022.
Fourth Quarter and 2021 Financial Overview:

Balance Sheet: Cash, cash equivalents, and marketable securities were $70.7 million as of December 31, 2021, compared to $19.2 million as of December 31, 2020. The quarterly and annual cash burn for 2021 reflects our capital-efficient, collaborator-centered business model.
R&D Expenses: Research and development expenses were $2.2 million and $7.6 million for the quarter and year ended December 31, 2021 compared to $1.4 million and $2.2 million for the quarter and year ended December 31, 2020, respectively. The annual increase was primarily attributable to increases in product candidate manufacturing related expenses of approximately $2.7 million, increases in research studies of approximately $0.8 million, increases in research and development payroll expenses of approximately $0.7 million, and an increase of $1.0 million related to the upfront payment to Allarity Therapeutics under the Allarity Asset Purchase Agreement, which was a nonrecurring expense.
G&A Expenses: General and administrative expenses were $1.4 million and $5.0 million for the quarter and year ended December 31, 2021 compared to $1.6 million and $3.7 million for the quarter and year ended December 31, 2020, respectively. The annual increase was primarily attributable to increases in business and corporate development expense of approximately $0.4 million, increases in corporate insurance expense of approximately $0.6 million, and increases in legal and patent related expenses of approximately $0.4 million.
Net Loss: Net losses were $3.5 million (or $0.31 per share) and $12.4 million (or $1.13 per share) for the quarter and year ended December 31, 2021, compared to a net loss of $2.9 million (or $0.47 per share) and $5.9 million (or $1.37 per share) for the quarter and year ended December 31, 2020, respectively.
2022 Key Objectives:

Launch of The Harmonicä Trial – Ph. 2 clinical trial for LP-300 in NSCLC
Advance LP-100 clinical trial
Launch Ph. 1 clinical trial for LP-184 in solid tumors
Launch Ph. 1/2 clinical trial for LP-184 in GBM
Progress LP-184 in ATRT towards Ph. 1/2 clinical trial
Advance pediatric cancer program
Advance ADC preclinical studies to support future Phase 1 launch
Explore potential combinations for LP-184 & LP-300 with other existing approved drugs
Strategically grow RADR A.I. platform to 25 billion datapoints
Licensing and partnership opportunities
2022 Outlook:
"During 2022 we expect to reach over 25 billion data points and also grow the methods and algorithms powering the analysis and insights of our RADR platform. Our team has been developing machine learning modules and algorithms that enable a wide range of analysis, correlations and predictions that are central to cancer drug development," added Sharma. "These additions to our platform are cornerstone to the advancement of our programs, and we believe this will be clearly demonstrated this year as we launch multiple clinical trials, report new data, and expand our collaborations."

"Our team will continue to advance our portfolio and our platform along with the development of new drug programs which we will be able to accomplish through our significant cash position, our focused strategy of collaborations and our data-driven drug development model. We are looking forward to a year of significant value creation for cancer patients and investors alike as we transform and accelerate the drug development process in oncology."

Earnings Call and Webinar Details
Lantern will host its fourth quarter and fiscal year 2021 earnings call and webinar today, Thursday, March 10 at 4:30 p.m. ET.

View Source
Related presentation materials will be accessible at: View Source
Replay Details

A replay of the 2021 earnings call and webinar will be available at View Source
(Press release, Lantern Pharma, MAR 10, 2022, View Source/news/press-releases/detail/82/lantern-pharma-reports-fourth-quarter-and-fiscal-year-2021" target="_blank" title="View Source/news/press-releases/detail/82/lantern-pharma-reports-fourth-quarter-and-fiscal-year-2021" rel="nofollow">View Source [SID1234609884])