On May 3, 2021 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 reported financial results for the first quarter ended March 31, 2021 (Press release, Lantern Pharma, MAY 3, 2021, View Source [SID1234579006]).

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"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."

On May 3, 2021 DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the first quarter of 2021 (Press release, DBV Technologies, MAY 3, 2021, View Source [SID1234579005]). The quarterly financial statements were approved by the Board of Directors on April 30, 2021.

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"I am pleased with DBV’s overall continued cost reduction measures through the first quarter of 2021," said Daniel Tasse, Chief Executive Officer, DBV Technologies. "We remain diligent about our spend and confident that our cash on hand as of March 31, 2021 will support our operations until the second half of 2022. We continue to focus our attention on advancing Viaskin Peanut’s regulatory dossier and developing our pipeline with the goal of improving the lives of patients with food allergies."

Q1 Financial Highlights1

Cash & Cash Equivalents: cash and cash equivalents as of March 31, 2021 were $152.5 million, compared to $196.4 million as of December 31, 2020. For the three months ended March 31, 2021, the net decrease of $43.9 million was primarily due to cash used in operating activities of $36.2 million and the effect of exchange rates on cash and cash equivalents of $7.9 million. Cash flows used in investment activities were $0.2 million and cash flows from financing activities were $0.4 million. Excluding restructuring amounts paid for $4.9 million on the first quarter of 2021, the cash used in operating activities amounts to $(31.3) million, reflecting the Company’s continued implementation of budget discipline measures. Based on its current assumptions, DBV expects that its current cash and cash equivalents will support its operations until the second half of 2022.

Operating Income: operating income was $2.9 million for the three months ended March 31, 2021, compared to $4.7 million for the three months ended March 31, 2020, a decrease of 37.7%. For both the three months ended March 31, 2021 and 2020, operating income was primarily generated from DBV’s Research Tax Credit (French Crédit Impôt Recherche, or CIR) and from revenue recognized by DBV under its collaboration agreement with Nestlé Health Science. The decrease in operating income is primarily attributable to a decrease of the CIR, as eligible expenses have declined in correlation with Research and Development costs.

Operating Expenses: Operating expenses for the three months ending March 31, 2021, were $32.6 million compared to $45.9 million for the three months ending March 31, 2020. The $13.4 million decrease in operating expenses is mainly attributable to the decrease in personnel expenses, which is directly related to the workforce reduction DBV implemented as part of its 2020 global restructuring plan. The personnel expenses decreased by $9.7 million, from $18.7 million for the three months ended March 31, 2020 to $9.0 million for the three months ended March 31, 2021, a 52% decrease, compared to a 61% decrease of the average number of headcounts between the two periods (311 and 121 FTEs for the three months ended March 31, 2020 and 2021 respectively). As of March 31, 2021, DBV had 104 employees. The decrease in other operating expenses was primarily due to the budget discipline measures taken by DBV. As a result of the ongoing COVID-19 pandemic, DBV also experienced a decrease in other expenses, in particular tradeshows and travel expenses.

Net Loss: Net loss was $(29.4) million for the three months ended March 31, 2021, compared to $(40.9) million for the three months ended March 31, 2020. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.54) and $(0.79) for the three months ended March 31, 2021 and 2020, respectively.

The Company will not host a conference call to discuss its first quarter 2021 financial results. It intends to host a conference call to discuss its half-year 2021 financial results in August.

On March 3, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its quarter ended March 31, 2021 and provided an update on recent business performance (Press release, Myriad Genetics, MAY 3, 2021, View Source [SID1234579004]).

Financial Highlights:
Myriad Genetics delivered total revenue in the quarter of $173.1 million which grew 6% year-over-year and increased 12% sequentially from the fiscal quarter ending December 31, 2020.

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Total test volumes of 236,000 declined 1% year-over-year but increased 5% sequentially. Average U.S. revenue per test increased 2% sequentially, reflecting an increasingly stable pricing environment. Average selling prices benefitted in the quarter from Medicare back pay revenue for the Prolaris test for prostate cancer.
GAAP gross margin was 70.9% and adjusted gross margin was 71.5%. Adjusted gross margin improved 140 basis points sequentially, impacted positively by test pricing and negatively by increased revenue mix from prenatal testing and lower margin pharmaceutical and clinical service revenue.
GAAP total operating expenses were $169.5 million. Total adjusted operating expenses increased $1.3 million year-over-year to $127.0 million.
GAAP operating loss in the quarter was ($46.7) million; adjusted operating loss of ($3.3) million.
GAAP earnings per share (EPS) were ($0.52); adjusted EPS were ($0.06) which improved by $0.06 sequentially.
Free cash flow in the quarter was $64.7 million and was driven by a significant federal tax refund of approximately $90 million. The company ended the quarter with $188.0 million in cash, cash equivalents and investments and $157.0 million drawn on its revolving credit facility.
Business Performance and Highlights

Women’s Health
The Myriad Women’s Health business — which serves women assessing their risk of cancer, and those who are pregnant or planning a family — recorded revenue of $55.2 million in the quarter, a decline of 15% year-over-year. Elective testing for hereditary cancer has been negatively impacted by the COVID-19 pandemic due to delayed elective office visits. The company’s prenatal business continued to demonstrate strong growth trends with test volumes increasing 9% year-over-year and 7% sequentially.

Myriad myRisk Hereditary Cancer
myRisk Hereditary Cancer test volumes for the Women’s Health business in the U.S. declined 25% year-over-year largely due to the impact of the pandemic.
Myriad Foresight Carrier Screen and Myriad Prequel Prenatal Screen
Myriad’s proprietary AMPLIFY technology, which further increases the performance of its Prequel noninvasive prenatal screening (NIPS) test, is leading to increased new prenatal users and test utilization. Since the launch of the AMPLIFY technology in July, Myriad has seen an increase of 12% in the total number of ordering providers for prenatal testing services, including Prequel and Foresight, with 11% growth in total test utilization per provider.
Oncology
The Myriad Oncology business provides hereditary cancer testing for patients who have cancer, and products such as the EndoPredict breast cancer prognostic test, the Prolaris prostate cancer test, and the myChoice CDx and BRACAnalysis CDx companion diagnostic tests for predicting response to PARP inhibitors. The Oncology business delivered total revenue of $75.6 million, up 39% relative to revenue in the March quarter of last year.

Myriad myRisk Hereditary Cancer
myRisk Hereditary Cancer test volumes for the Oncology business in the U.S. declined 9% year-over-year.
Myriad Prolaris Prostate Cancer
Presented new data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Conference demonstrating the Prolaris test can accurately predict which patients will benefit from multi-modality therapy. Using the newly established threshold, 27% of men with newly diagnosed high-risk disease and 73% with unfavorable intermediate-risk disease could avoid multimodality therapy.
Myriad BRACAnalysis CDx and myChoice CDx
Saw significant increases in BRACAnalysis CDx and myChoice CDx test volume in Japan with total revenue from the country increasing more than four-fold year-over-year to $11.9 million.
Received new reimbursement for the myChoice diagnostic system in Japan effective January 1, 2021.
New Tumor Profiling Product:
Announced new partnership with Intermountain Precision Genomics, powered by technology from Illumina (NASDAQ: ILMN), for a comprehensive offering of germline and somatic tumor testing services. The strategic collaboration combines germline genetic testing, next-generation tumor sequencing and world-class testing capabilities to elevate global precision oncology care.
Mental Health
Myriad’s Mental Health business — which consists of the GeneSight psychotropic test that helps physicians understand how genetic alterations impact response to antidepressant and other psychotropic medications — saw revenue of $17.6 million in the quarter compared to $20.4 million in the same period last year. Test volume for GeneSight was up 17% sequentially.

Myriad GeneSight
Saw a strong increase in new ordering providers with over 2,600 physicians ordering GeneSight for the first time in the quarter, up 24% sequentially. Overall, the number of ordering physicians increased 10% sequentially and test utilization per provider increased 4% sequentially despite the strong growth in new ordering providers.
Published a new study in Psychiatry Research demonstrating that the combinatorial approach available in the GeneSight Psychotropic test is better than single-gene testing at predicting patient outcomes and medication blood levels.
Autoimmune
Myriad’s Autoimmune business — which consists of the Vectra test for measuring disease activity in rheumatoid arthritis — generated revenue of $10.7 million in the quarter compared to $10.5 million in the same period last year.

Vectra
Signed a definitive agreement to sell select operating assets and intellectual property (IP), including the Vectra test, from Myriad Autoimmune’s business unit to Laboratory Corporation of America Holdings (NYSE: LH) for $150.0 million in cash. The deal is expected to close by the end of the third quarter of calendar year 2021.
Other
Other revenue – comprised of Myriad RBM contract research services for the pharmaceutical industry and the myPath Melanoma diagnostic test in dermatology — was $14.0 million in the March quarter versus $14.0 million in the same period in the prior year.

Signed a definitive agreement to sell the Myriad myPath, LLC, Laboratory, which is the laboratory that offers the myPath Melanoma test, to Castle Biosciences, Inc. for $32.5 million in cash. The transaction is expected to close in the second quarter of calendar year 2021.
The company generated $2.5 million in the quarter from COVID-19 testing services. Given the declining demand for testing in the United States, Myriad does not expect to have significant COVID-19 testing revenue going forward.
Investor Day
Myriad will host an Investor Day tomorrow, May 4, 2021 at 11:00 am EDT, to provide an update on its transformation plan and growth initiatives. The Investor Day will be a virtual event hosted on the company’s website. The link to the Investor Day event and registration is under the investor relations section of the website.

Financial Guidance
Given the continued unpredictability surrounding the COVID-19 pandemic and the impact it has had on the healthcare environment, customer behavior and the ability to market tests to physicians, the company will not provide financial guidance for the quarter ending June 30, 2021 or fiscal year 2021.

On May 3, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three months ended March 31, 2021 and provided an operating forecast and program updates (Press release, Ligand, MAY 3, 2021, View Source [SID1234579003]). Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions.

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"This year has opened strong for Ligand with solid financial performance and great results from all of our core technology platforms," said John Higgins, Chief Executive Officer. "We are very pleased to report a smooth and efficient integration of the four acquisitions we closed last year. Our R&D team has expanded considerably and we are reaping the benefits of these transactions with more licensing deals and contract revenue. Working within a highly dynamic and unpredictable COVID-19 landscape, we continue to play a key role supporting the manufacture of remdesivir through the supply of Captisol to numerous partners around the globe. We anticipate 2021 will be the highest year of total revenues in Ligand’s history, and we look forward to multiple regulatory approvals later this year of drugs based on our technologies."

First Quarter 2021 Financial Results

Total revenues for the first quarter of 2021 were $55.2 million, compared with $33.2 million for the same period in 2020. Royalties for the first quarter of 2021 were $7.1 million, compared with $6.6 million for the same period in 2020. Captisol sales were $31.3 million for the first quarter of 2021, compared with $21.1 million for the same period in 2020, with the increase primarily due to higher sales of Captisol for use with remdesivir. Contract revenue was $16.8 million for the first quarter of 2021, compared with $5.5 million for the same period in 2020, with the increase primarily due to the timing of partner milestone events and the acquisitions of Icagen in April 2020 and Pfenex in October 2020.

Cost of Captisol was $8.2 million for the first quarter of 2021, compared with $4.7 million for the same period in 2020, with the increase primarily due to higher sales of Captisol. Amortization of intangibles was $11.8 million for the first quarter of 2021, compared with $3.5 million for the same period in 2020, with the increase primarily due to amortization of contractual relationships and technologies acquired from Icagen and Pfenex. Research and development expense was $17.9 million for the first quarter of 2021, compared with $11.9 million for the same period of 2020, with the increase primarily due to additional expenses following the Icagen and Pfenex acquisitions. General and administrative expense was $12.6 million for the first quarter of 2021, compared with $9.3 million for the same period in 2020, with the increase primarily due to additional expenses following the Icagen and Pfenex acquisitions.

Net income for the first quarter of 2021 was $18.1 million, or $1.05 per diluted share, compared with net loss of $(24.1) million, or $(1.46) per share, for the same period in 2020. Net income for the first quarter of 2021 included a $9.1 million net non-cash gain from the value of Ligand’s short-term investments, while net loss for the first quarter of 2020 included a $(29.7) million net non-cash loss from the value of Ligand’s short-term investments. Adjusted net income for the first quarter of 2021 was $24.3 million, or $1.41 per diluted share, compared with $15.3 million, or $0.89 per diluted share, for the same period in 2020. Please see the table below for a reconciliation of net income/(loss) to adjusted net income.

As of March 31, 2021, Ligand had cash, cash equivalents and short-term investments of $339.2 million.

2021 Financial Guidance

Ligand today affirms its guidance for 2021 total revenues to be approximately $291 million and 2021 adjusted earnings per diluted share to be approximately $6.15. Ligand’s revenue guidance is subject to unexpected changes in demand for Captisol related to remdesivir and the timing and amount of contract payments from milestone events. Ligand may update total revenue guidance at any time during the year, in particular as the COVID-19 pandemic and demand for Captisol related to remdesivir continue to evolve.

First Quarter 2021 and Recent Business Highlights

In February, Travere announced that sparsentan achieved its pre-specified interim focal segmental glomerulosclerosis (FSGS) partial remission of proteinuria endpoint (FPRE) in the DUPLEX Phase 3 study after 36 weeks of treatment. Sparsentan demonstrated a statistically significant response on FPRE compared with the active control, irbesartan (p=0.0094). Preliminary results from the interim analysis suggest that sparsentan was generally well-tolerated and showed a comparable safety profile to irbesartan. Based on the data from the interim analysis, Travere intends to pursue submissions for accelerated approval of sparsentan for FSGS in the second half of 2021. Additionally, in February the European Commission granted orphan designation to sparsentan for the treatment of IgA nephropathy (IgAN), a rare kidney disorder and a leading cause of end-stage kidney disease. Travere is conducting an ongoing, global pivotal Phase 3 clinical trial (PROTECT) to evaluate the long-term nephroprotective potential of sparsentan for the treatment of IgAN. Travere anticipates topline interim efficacy data in the third quarter of 2021.

OmniAb Platform Updates

OmniAb is Ligand’s industry-leading, AI- and BI- (Biological Intelligence) powered multi-species antibody platform for the discovery of mono- and bispecific therapeutic human antibodies. 2020 was a year of major investment with the acquisition and development of multiple technologies that enhance the offering for OmniAb partners, including the addition of antigen-generation services as well as deep-sequence analysis of functional antibody repertoires. As of March 31, 2021, 17 different OmniAb-derived antibodies have been studied in approximately 73 active or completed clinical trials. Progress by multiple OmniAb partners during the first quarter resulted in more than $4 million in milestone payments being earned by Ligand. Ligand expects the first regulatory approvals for OmniAb-derived antibodies in 2021.

On January 11, Aptevo Therapeutics provided an update on their ongoing Phase 1/1b trial of APVO436 in AML/HR-MDS, noting that patient dosing in cohorts 1 through 9 has completed and enrollment in cohort 10 is ongoing. APVO436 is an OmniAb-derived bispecific antibody targeting CD123 and CD3 for the potential treatment of hematological malignancies.

On February 8, CStone Pharmaceuticals announced that the OmniAb-derived anti-PD-L1 antibody sugemalimab was granted Breakthrough Therapy Designation (BTD) in China for the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL). In October 2020, sugemalimab was granted Orphan Drug Designation in the U.S. for the treatment of T-cell lymphoma and BTD for the treatment of R/R ENKTL. A New Drug Application (NDA) for sugemalimab is under review in China for Stage IV squamous/non-squamous non-small cell lung cancer, and CStone expects a determination in the second half of 2021.

On January 27, Harbour BioMed announced that Batoclimab (HBM9161), a novel investigational anti-FcRn antibody, was granted BTD in China for treatment of adult patients with myasthenia gravis.

Pelican Platform Updates

The Pelican Expression Technology is Ligand’s proprietary Pseudomonas fluorescens protein expression technology that has major collaborations with Jazz Pharmaceuticals, Merck, Serum Institute of India and Alvogen, each of which has potential to contribute meaningfully to Ligand’s royalty revenue.

On January 12, Merck announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.

On January 18, Alvogen’s partner Thermarex announced the launch of Livogiva in the EU. Livogiva is a biosimilar of the reference medicine Forsteo (teriparatide) and therapeutic equivalence has been demonstrated in a Phase 3 clinical study in patients with severe osteoporosis who were treated for 6 months.

On April 6, Arcellx announced FDA clearance of their Investigational New Drug application for ACLX-001, an engineered cell therapy for the treatment of multiple myeloma. Arcellx presented preclinical data supporting Arcellx’s ARC-SparX platform cell therapy ACLX-001, a novel BCMA-targeted CAR-T, at the AACR (Free AACR Whitepaper) annual meeting in April of 2021.

Captisol Business Updates

Captisol is utilized in the formulation of Gilead Sciences’ Veklury (remdesivir). The product has been approved or authorized for temporary use as a treatment for COVID-19 in approximately 50 countries worldwide and is included in more than 40 ongoing interventional or observational clinical studies. In addition to supplying Gilead, Ligand is also supplying Captisol to Gilead’s voluntary licensing generic partners who are manufacturing remdesivir for 127 other countries. Gilead announced the decision to stop its Phase 3 study with intravenous Veklury in high-risk non-hospitalized patients with COVID-19 due to the evolution of the COVID-19 landscape. Gilead stated they continue to develop an investigational inhaled dosage form of remdesivir and expect results from the ongoing proof-of-concept study later this year.

On March 31, the FDA approved the addition of the anti-CD38 monoclonal antibody (mAb) Sarclisa (isatuximab) to the combination of Kyprolis (carfilzomib) and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. Kyprolis is also approved in combination with the anti-CD38 mAb Darzalex (daratumumab) plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received a maximum of three prior lines of therapy.

On April 27, Aldeyra announced positive topline results from the Phase 3 INVIGORATE trial of 0.25% reproxalap ophthalmic solution (reproxalap), an investigational, novel small-molecule covalent inhibitor of RASP (reactive aldehyde species), in patients with allergic conjunctivitis. The clinical trial achieved statistical significance (p<0.0001) for the primary endpoint of change from baseline in subject-reported ocular itching score, and all secondary endpoints including investigator-assessed ocular redness, patient-reported ocular tearing score and total ocular severity score. Aldeyra plans to meet with the FDA in the second half of 2021 to discuss the INVIGORATE results and the potential submission of an NDA.

Other Business Updates

On April 21, Sermonix Pharmaceuticals announced a preclinical collaboration with Jay Gertz, Ph.D., a researcher at the Huntsman Cancer Institute and associate professor of oncological sciences at the University of Utah, to examine the potential effects of lasofoxifene on unique models of endometrial cancer that carry ESR1 mutations. Lasofoxifene has shown novel activity in ESR1 mutations, and Sermonix is currently enrolling patients in two Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) studies in metastatic breast cancer.

Ligand provides regular updates on individual partner events through its Twitter account, @Ligand_LGND.

Adjusted Financial Measures

The Company reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include share-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, other than with respect to total revenues, the Company only provides financial guidance on an adjusted basis and does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, stock-based compensation expense and effects of any discrete income tax items. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

Conference Call

Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (833) 540-1167 from the U.S. or (929) 517-0358 from outside the U.S., using the conference ID 7398698. To participate via live or replay webcast, a link is available at www.ligand.com.

About OmniAb

The OmniAb antibody discovery platform provides Ligand’s biopharmaceutical industry partners access to the world’s most advanced antibody repertoires and screening technologies to enable unparalleled discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of our proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse, each capable of generating high quality fully human antibodies that have been optimized naturally through in vivo affinity maturation. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. OmniAb animals comprise the most diverse host systems available in the industry and they are optimally leveraged through AI-enhanced antigen design and immunization methods, paired with high-throughput microfluidic-based single B cell screening and deep computational analysis of next-generation sequencing datasets to identify fully human antibodies with superior performance and developability characteristics. The OmniAb suite of technologies and differentiating AI and BI features are combined to offer a highly efficient and customizable end-to-end solution for the growing antibody discovery needs of the global biopharmaceutical industry.

About the Pelican Expression Technology

Pelican is a robust, validated, cost-effective and scalable platform for recombinant protein production, and is especially well-suited for complex, large-scale protein production where traditional systems are not suitable. Multiple global manufacturers have demonstrated consistent success with the platform and the technology is currently out-licensed for numerous commercial and development-stage programs. The versatility of the platform has been demonstrated in the production of enzymes, peptides, antibody derivatives and engineered non-natural proteins. Partners seek the platform as it can contribute significant value to biopharmaceutical development programs by reducing development timelines and costs for manufacturing therapeutics and vaccines. Given pharmaceutical industry trends toward large molecules with increasing structural complexities, Pelican is well positioned to meet these growing needs as the most comprehensive broadly available protein production platform in the industry.

About Captisol

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Gilead’s VEKLURY, Amgen’s KYPROLIS, Baxter International’s NEXTERONE, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA, Melinta Therapeutics’ BAXDELA and Sage Therapeutics’ ZULRESSO. There are many Captisol-enabled products currently in various stages of development. Ligand maintains a broad global patent portfolio for Captisol with more than 400 issued patents worldwide relating to the technology (including over 40 in the U.S.) and with the latest expiration date in 2033. Other patent applications covering methods of making Captisol, if issued, extend to 2040.

On May 3, 2021 The board of directors of Eli Lilly and Company (NYSE: LLY) (the "Board") reported that it has declared a dividend for the second quarter of 2021 of $0.85 per share on outstanding common stock (Press release, Eli Lilly, MAY 3, 2021, View Source [SID1234579002]). The dividend is payable on June 10, 2021 to shareholders of record at the close of business on May 14, 2021.

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The Board has also authorized the repurchase of up to an additional $5 billion of the company’s common stock. This repurchase authorization is in addition to the authorization remaining under the share repurchase program authorized by the Board in June 2018. As of March 31, 2021, there was $1 billion remaining under the 2018 share repurchase program.

Purchases may be made from time to time at management’s discretion. The share repurchase authorizations permit shares to be repurchased in a variety of methods, including open market purchases, accelerated share repurchases, or other privately negotiated transactions. The share repurchase authorizations have no time limit and may be suspended or discontinued at any time.