On April 29, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (BioMarin or the Company) reported its financial results for the first quarter ended March 31, 2021 (Press release, BioMarin, APR 29, 2021, View Source [SID1234578779]).

"We mark the start of 2021 with strong financial results, and a number of exciting regulatory decisions ahead this year." said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin. "The potential approval in Europe this summer of vosoritide, the first potential therapeutic option for children with achondroplasia, will set the stage for our next significant phase of growth, especially considering the EMEA region is 3 times larger than the U.S. market. To date, the interactions with the review team at the European Medicines Agency have been very positive. Next, we plan to re-submit the application for valoctocogene roxaparvovec gene therapy, to treat hemophilia A, to the EMA in the second quarter, to be followed by potential approval of vosoritide in the United States later this year."

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Mr. Bienaimé continued, "We are well positioned to deliver strong results for the full-year 2021, and reaffirm our financial guidance provided early this year. This takes into consideration the uneven ordering patterns in our dynamic and global commercial business, as well as continued uncertainty outside of the United States from COVID-19, and further underscores the essential nature of our products to the people who rely on them. Taken together, our financial strength, including positive cash flows from operations of $113.5 million in the first quarter, combined with near-term opportunities from potential new products and a robust early-stage pipeline, we believe that 2021 will be pivotal to BioMarin’s evolution."

Financial Highlights:
•Net Product Revenues for the first quarter of 2021 decreased to $467.8 million, compared to $489.0 million for the same period in 2020. The decrease in Net Product Revenues was primarily attributed to the following:
•Lower Kuvan product revenues primarily due to known generic competition in the U.S.; partially offset by
•Higher Vimizim product revenues primarily due to timing of orders from Europe, Middle East and North Africa; and
•Higher Palynziq product revenues primarily driven by a combination of revenue from more U.S. patients achieving maintenance dosing and new patients initiating therapy.

•GAAP Net Income decreased $64.0 million to $17.4 million for the first quarter of 2021 compared to $81.4 million for the same period in 2020. The decrease was primarily due to the absence of the gain on sale the Firdapse commercial assets totaling $59.5 million in the first quarter of 2020 and a decrease in gross profits due to the lower Kuvan product revenues due to generic competition in the U.S. This decrease was partially offset by lower selling, general and administrative (SG&A) expenses primarily due to a decrease in foreign currency exchange losses in the first quarter of 2021.

•Non-GAAP Net Income for the first quarter of 2021 decreased to $104.4 million compared to Non-GAAP Income of $116.5 million for the same period in 2020. The decline in Non-GAAP Income for the quarter, compared to the same period in 2020, was primarily attributed to lower gross profits, partially offset by lower SG&A expenses primarily due to a decrease in foreign currency exchange losses in the first quarter of 2021.
Commercial Portfolio (Naglazyme, VIMIZIM, Brineura, Palynziq, Kuvan and Aldurazyme)
•Naglazyme, VIMIZIM and Brineura maintained robust patient compliance in the quarter and continue to grow based on strong underlying demand.
◦Patients on commercial Naglazyme and Vimizim therapy both increased approximately 10% year-over-year.
2

◦Patients on commercial Brineura therapy increased by more than 30% year-over-year.
•Order timing for both Naglazyme and VIMIZIM are expected to be more concentrated in the first half of 2021 as compared to the second half of 2021.
•Palynziq top-line results in 2021 are expected to increase approximately 35% based on the mid-point of full-year 2021 guidance as compared to full-year 2020 results.
•Palynziq growth in European, Middle East and African regions (EMEA) has been impacted by ongoing challenges due to COVID-19 with Palynziq revenue from EMEA expected to increase when PKU clinics have more freedom to operate and start additional patients.
◦The number of U.S. Patients on commercial Palynziq therapy increased more than 20% year-over-year and is expected to continue to grow as U.S. PKU clinics re-open over the coming quarters.
•Loss of Kuvan U.S. market share, due to the introduction of generics following BioMarin’s loss of U.S. market exclusivity, is consistent with expectations.
•Aldurazyme contributions were driven by the timing of product released and transfer of control to Genzyme, who is responsible for marketing Aldurazyme worldwide.
Late-stage Regulatory Portfolio (Vosoritide and valoctocogene roxaparvovec)
•In Europe, with respect to vosoritide for the treatment of achondroplasia, BioMarin is in the final stages of the review procedure ahead of the anticipated June 2021 Committee for Medicinal Products for Human Use (CHMP) opinion. Assuming a positive CHMP opinion, the European Commission could potentially grant marketing authorization for vosoritide in the third quarter of 2021.
•In Europe, with respect to valoctocogene roxaparvovec for the treatment of severe hemophilia A, based on positive pre-submission feedback in the current quarter, BioMarin reaffirms its plan to submit the Marketing Authorization Application with one-year results from the Phase 3 GENEr8-1 study to the European Medicines Agency (EMA) in June 2021.
•In the U.S., BioMarin provided the U.S. Food and Drug Administration (FDA) with the two-year results from the Phase 3 extension study with vosoritide to supplement the New Drug Application (NDA) already under review. As anticipated, the FDA designated this submission as a major amendment to the application, thus extending the Prescription Drug User Fee Act (PDUFA) target action date by three months to November 20, 2021 to provide time for a full review of the submission.
◦Also in the first quarter of 2021, the FDA pre-approval inspection of BioMarin’s Novato facility for the manufacture of vosoritide drug substance was completed, representing another important milestone as vosoritide advances through the review process.
•During the current quarter, the FDA reiterated their recommendation that BioMarin submit two-year follow-up safety and efficacy data on all study participants from the GENEr8-1 study to support their benefit/risk assessment of valoctocogene roxaparvovec. BioMarin is targeting a Biologics License Application (BLA) submission in the second quarter of 2022 assuming favorable results, followed by an expected 6-month review procedure by the FDA.
◦The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to valoctocogene roxaparvovec. The RMAT designation is complementary to Breakthrough Therapy Designation, which BioMarin received in 2017.
3

Earlier-stage Development Portfolio (BMN 307, BMN 255, BMN 331, DiNA-001, Allen Institute Collaboration)
◦BMN 307: Dose escalation in PHEarless, the Phase 1/2 study of BMN 307 continues based on encouraging Phe lowering and safety profile observed in study participants who were treated with the lowest dose.
◦BMN 255 for a subset of chronic renal disease: On January 11, 2021 BioMarin announced that it had filed an IND in 2020 for BMN 255, a small molecule for a subset of chronic renal disease. BMN 255 was driven by genetic discoveries for both mechanism and for identifying individuals for treatment.

◦BMN 331 gene therapy product candidate for Hereditary Angioedema (HAE): IND-enabling studies are ongoing with BMN 331 for the treatment of HAE, BioMarin’s third gene therapy candidate. BioMarin plans to leverage its broad expertise in developing gene therapies for severe hemophilia A and PKU to improve efficiencies in the development process of BMN 331. BioMarin is on track to file an IND for BMN 331 mid-year 2021.

◦BMN 351 for Duchenne Muscular Dystrophy (DMD): IND-enabling studies are underway with BMN 351, an antisense oligonucleotide therapy that has demonstrated dystrophin expression levels of 30-50% of wild-type levels in the quadriceps in a DMD mouse model treated at 18.7 mg/kg/week for 13 weeks (measured 2 weeks following last administration). If results from the ongoing pre-clinical studies are supportive, BioMarin anticipates filing an IND for BMN 351 in the first half of 2022.

◦DiNA-001 for MYBPC3 hypertrophic cardiomyopathy (HCM): Pre-clinical studies are underway with DiNA-001 following a collaboration announced in 2020 with DiNAQOR, a gene therapy platform company, to develop novel gene therapies to treat rare genetic cardiomyopathies. DiNAQOR received an undisclosed upfront payment and is eligible to receive development, regulatory and commercial milestones on product sales in addition to tiered royalties on worldwide sales.

◦On April 28, 2021, BioMarin and the Allen Institute announced a collaboration to create new gene therapies aimed at rare genetic diseases of the central nervous system (CNS). The goal is to combine the Allen Institute’s leadership in large-scale genomic science in the CNS therapeutic area with BioMarin’s expertise in developing transformational gene therapies.
2021 Full-Year Financial Guidance (in millions, except %)

Item

2021 Guidance * (reaffirmed)
Total Revenues

$1,750

to

$1,850
Vimizim Net Product Revenues

$570

to

$610
Kuvan Net Product Revenues

$250

to

$290
Naglazyme Net Product Revenues

$365

to

$395
Palynziq Net Product Revenues

$210

to

$250
Brineura Net Product Revenues

$120

to

$140

Cost of Sales (% of Total Revenues)

23
%

to

25%
Research and Development Expense

$645

to

$695
Selling, General and Administrative Expense

$725

to

$775

GAAP Net Loss

($130)

to

($80)
Non-GAAP Income (1)

$170

to

$220

On April 29, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the first quarter 2021 (Press release, Gilead Sciences, APR 29, 2021, View Source [SID1234578778]).

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"We have made strong progress in this first quarter, with our new partnership with Merck in long-acting HIV therapies, two newly approved indications in the U.S. for Trodelvy in metastatic triple-negative breast cancer and metastatic urothelial cancer, and the addition of Hepcludex to our portfolio," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "2021 is a pivotal year for Gilead, with key milestones across our virology and oncology portfolios. We’re looking forward to advancing our pipeline of promising therapies in the coming months."

First Quarter 2021 Financial Results

•Total first quarter 2021 revenue of $6.4 billion increased 16% compared to the same period in 2020, primarily due to Veklury (remdesivir) sales, Cell Therapy growth with Yescarta (axicabtagene ciloleucel) and the U.S. launch of Tecartus (brexucabtagene autoleucel) in the third quarter 2020, the first full quarter recognition of Trodelvy (sacituzumab govitecan-hziy 180 mg) sales, and Hepatitis B virus ("HBV") growth with Vemlidy (tenofovir alafenamide 25 mg).

•Diluted Earnings Per Share ("EPS") increased 12% to $1.37 for the first quarter 2021 compared to the same period in 2020, primarily driven by revenue growth, partially offset by fair value loss adjustments related to Gilead’s equity investment in Galapagos NV ("Galapagos") and lower interest income.
•Non-GAAP diluted EPS increased 24% to $2.08 for the first quarter 2021 compared to the same period in 2020, primarily due to higher operating income and lower effective tax rate, offset by lower interest income.
•As of March 31, 2021, Gilead had $6.2 billion of cash, cash equivalents and marketable debt securities compared to $7.9 billion as of December 31, 2020.
•During the first quarter 2021, Gilead generated $2.6 billion in operating cash flow.
•During the first quarter 2021, Gilead repaid $1.3 billion of debt, utilized $1.3 billion on acquisitions, net of cash acquired (including in-process research and development ("IPR&D")), paid cash dividends of $917 million and utilized $309 million on repurchases of common stock.

Product Sales Performance

Total first quarter 2021 product sales increased 16% to $6.3 billion compared to the same period in 2020. Total product sales excluding Veklury decreased 11% to $4.9 billion for the first quarter 2021 compared to the same period in 2020, with contributions from new product launches such as Tecartus and Trodelvy offset, as expected, by loss of exclusivity of Truvada (emtricitabine 200 mg ("FTC") and tenofovir disoproxil fumarate 300 mg ("TDF")) and Atripla (efavirenz 600 mg/FTC/TDF) in the United States and COVID-19 pandemic-related impacts in both HIV and hepatitis C virus ("HCV").
HIV product sales decreased 12% to $3.7 billion for the first quarter 2021 compared to the same period in 2020, reflecting the expected loss of exclusivity of Truvada and Atripla in the United States, in addition to channel inventory dynamics including COVID-19 pandemic-related stocking in the first quarter 2020.

April 29, 2021

2

•Biktarvy (bictegravir 50 mg/FTC/tenofovir alafenamide 25 mg ("TAF")) sales increased 8% year-over-year in the first quarter 2021, reflecting robust market share gains across core markets and partially offset by channel inventory dynamics.
•Descovy (FTC/TAF) sales decreased 22% year-over-year in the first quarter 2021, driven by lower average net selling price and channel inventory dynamics including COVID-19 pandemic-related stocking in the first quarter 2020, in addition to the ongoing COVID-19 pandemic-related effects on the pre-exposure prophylaxis ("PrEP") market.
•Truvada and Atripla sales decreased 67% year-over-year to $135 million and $31 million, respectively, in the first quarter 2021, following loss of exclusivity in the United States in October 2020.
HCV product sales decreased 30% to $510 million for the first quarter 2021 compared to the same period in 2020. Sales volumes were impacted by lower patient starts in the United States and Europe associated with the COVID-19 pandemic.
HBV and hepatitis delta virus ("HDV") product sales increased 18% to $220 million for the first quarter 2021 compared to the same period in 2020. Vemlidy sales increased 33% in the first quarter 2021 compared to the same period in 2020. Hepcludex (bulevirtide) contributed $6 million in sales subsequent to Gilead’s acquisition of MYR GmbH ("MYR"), representing a partial quarter of sales.
Cell Therapy product sales increased 36% to $191 million for the first quarter 2021 compared to the same period in 2020.
•Yescarta sales increased to $160 million in the first quarter 2021, reflecting increased uptake and geographic expansion in Europe.
•Tecartus sales were $31 million for the first quarter 2021 as launch activities continue to ramp up in the United States.
Trodelvy sales for the first quarter 2021 were $72 million, representing the first full quarter of sales for Gilead.
Veklury sales were $1.5 billion for the first quarter 2021. Sales of Veklury are generally affected by COVID-19 related rates of infections, hospitalizations and vaccinations.
Other product sales decreased 13% to $241 million for the first quarter 2021 compared to the same period in 2020.
•Letairis (ambrisentan 5 mg and 10 mg) and Ranexa (ranolazine 500 mg and 1000 mg) sales decreased in the first quarter 2021, as expected, as generic competition continues to gain share following loss of exclusivity in 2019.
First Quarter 2021 Product Gross Margin, Operating Expenses and Tax
•Product gross margin was 78.5% for the first quarter 2021 compared to 82.3% in the same period in 2020. Non-GAAP product gross margin was 86.5% for the first quarter 2021 compared to 87.1% in the same period in 2020, reflecting a less favorable product mix and an inventory charge, partially offset by favorable royalty adjustments.
•Research and Development ("R&D") expenses for the first quarter 2021 were $1,055 million compared to $1,004 million in the same period in 2020. Non-GAAP R&D expenses for the first quarter 2021 were $1,049 million compared to $1,004 million in the same period in 2020. The higher R&D expenses included ramp-up of magrolimab and Trodelvy clinical activities, partially offset by study completions and discontinuations.
•Sales, General and Administrative ("SG&A") expenses for the first quarter 2021 were $1,055 million compared to $1,076 million in the same period in 2020. Non-GAAP SG&A expenses for the first quarter 2021 were $1,033 million compared to $1,076 million in the same period in 2020. The lower SG&A expenses reflect lower promotional spend in HIV and HCV and timing of grants, partially offset by increased commercialization investments for Veklury, Trodelvy, Cell Therapy, and HBV and HIV in China.

April 29, 2021

3

•The GAAP effective tax rate ("ETR") and non-GAAP ETR for the first quarter 2021 were 23.9% and 18.4%, respectively, compared to 23.2% and 19.7% for the same period in 2020, respectively.
Key Updates Since Our Last Quarterly Release
Viral Diseases
• Gilead announced a collaboration with Merck Sharp & Dohme Corp ("Merck"), a subsidiary of Merck & Co., Inc., to develop and commercialize long-acting, investigational treatment combinations of Gilead’s lenacapavir and Merck’s islatravir in HIV. The first clinical studies of the oral combination are expected to begin in the second half of 2021.
• At the Conference on Retroviruses and Opportunistic Infections ("CROI"), Gilead presented additional results from lenacapavir’s Phase 2/3 CAPELLA trial. The interim efficacy results showed lenacapavir maintained high rates of virologic suppression through 26 weeks among heavily treatment-experienced people with multi-drug resistant HIV; 73% of participants who reached Week 26 since the first dose of subcutaneous lenacapavir with an optimized background regimen achieved undetectable viral load.
• At CROI, Gilead presented data from an open label-extension of two Phase 3 studies of Biktarvy, demonstrating sustained safety and efficacy with greater than 98% of treatment-naïve participants achieving and maintaining undetectable viral load through four years of follow-up.
Oncology
• The New England Journal of Medicine published primary results from the randomized confirmatory Phase 3 ASCENT study of Trodelvy in metastatic triple-negative breast cancer ("mTNBC"). The publication demonstrated that Trodelvy significantly extended both progression-free survival and overall survival for patients compared to standard single-agent chemotherapy.
•U.S. Food and Drug Administration ("FDA") granted accelerated approval of Trodelvy for adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or programmed death-ligand 1 inhibitor.
• FDA granted full approval of Trodelvy for adult patients with unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
• European Medicines Agency ("EMA") validated the Marketing Authorization Application and granted accelerated review for Trodelvy for the treatment of mTNBC.
• FDA approved Yescarta for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Yescarta is the first CAR T therapy approved for indolent follicular lymphoma.
• Gilead and Kite announced new analysis from the ZUMA-1 trial of Yescarta in a cohort of adult patients with relapsed or refractory large B-cell lymphoma. Findings suggest use of corticosteroids prior to Yescarta infusion has potential to impact the benefit/risk profile.
Inflammatory Diseases
• Gilead and Novo Nordisk A/S ("Novo Nordisk") expanded their clinical collaboration in non-alcoholic steatohepatitis ("NASH") with plans to launch a new Phase 2b for a triple combination regimen in NASH patients with cirrhosis.
• Gilead and Galapagos discontinued ISABELA Phase 3 trials in idiopathic pulmonary fibrosis.
Corporate
• In response to the rapid increase in COVID-19 in India, Gilead announced that it would provide voluntary licensees with technical assistance to expand local production capacity, support for the addition of new manufacturing facilities and a donation of active pharmaceutical ingredient. Gilead will also donate at least 450,000 vials of Veklury to the government of India.
•Gilead welcomed Flavius Martin, MD, as Executive Vice President, Research, following the retirement of William A. Lee, PhD. Dr. Martin brings decades of experience in early drug discovery research.

April 29, 2021

4

• Gilead completed the acquisition of MYR for up to approximately €1.3 billion (or $1.6 billion) in aggregate consideration. The acquisition provides Gilead with Hepcludex, which is conditionally approved by EMA for the treatment of chronic HDV in adults with compensated liver disease.
• Kite appointed Frank Neumann, MD, PhD, as Worldwide Head of Clinical Development. Dr. Neumann has a record of proven leadership in cell therapy and oncology clinical development.
Guidance and Outlook

The COVID-19 pandemic is expected to continue to impact our business and broader market dynamics, such as HCV treatment initiations and HIV new starts and switches. We now expect a more gradual recovery in the COVID-19 related dynamics starting in the second quarter 2021, and the rate and degree of recovery may vary by geography. Sales of Veklury will continue to be subject to significant volatility and uncertainty. As a result, Gilead believes providing full year 2021 revenue guidance excluding Veklury is useful for investors, when considered in conjunction with its GAAP financial information.

Except for GAAP earnings per diluted share, there is no change to the guidance shared on February 4, 2021, including: full year product sales excluding Veklury between $21.7 billion and $22.1 billion; full year Veklury sales between $2 billion and $3 billion; total product sales for 2021 between $23.7 billion and $25.1 billion; and non-GAAP earnings per share for 2021 between $6.75 and $7.45. GAAP earnings per diluted share for 2021 is now expected to be between $4.75 and $5.45, updated primarily for actual changes in fair value of equity investments in the first quarter 2021. A reconciliation between GAAP and non-GAAP financial information for the 2021 guidance is provided in the table on page 12.

Non-GAAP Financial Information

The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information excludes acquisition-related expenses including amortization of acquired intangible assets and inventory step-up charges in cost of goods sold, acquired IPR&D expenses, and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with changes in tax related laws and guidelines. Acquired IPR&D expenses reflect IPR&D impairments as well as the initial costs of externally developed IPR&D projects, acquired directly in a transaction other than a business combination, that do not have an alternative future use, including upfront payments related to various collaborations and the initial costs of rights to IPR&D projects. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the tables on pages 10 – 11.

Conference Call

At 4:30 p.m. Eastern Time today, Gilead will host a conference call to discuss Gilead’s results. The live webcast can be accessed through the Gilead website at View Source Alternatively, individuals can access the call by dialing 877-359-9508 (U.S.) or 224-357-2393 (international) with conference ID 5069935. A replay of the conference call will be posted on the Gilead website after the event and will be available for one year.

On April 29, 2021 Novo Seeds, the early stage investment and company creation team of Novo Holdings, reported an investment in Adcendo, a Danish biotech company which is developing antibody-drug conjugates (ADCs) for the treatment of cancers (Press release, Novo, APR 29, 2021, View Source [SID1234578812]). The EUR 51 million (US$ 62 million) Series A financing was led by Novo Seeds and Ysios Capital, along with RA Capital Management, HealthCap and Gilde Healthcare.

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The new financing, which is the largest Series A financing for a Danish biotech company, will be used to establish a pipeline of ADCs directed at novel cancer targets and to bring the lead program targeting the novel cancer target uPARAP/Endo180 to proof of concept in patients.

The company has been supported by Novo Seeds since 2017 and was incubated in 2018 at the BioInnovation Institute (BII), an international life sciences incubator in Copenhagen. Novo Seeds supported the company amongst others through leveraging its network in industry and academia to recruit world-renowned experts to the company’s Scientific Advisory Board. As part of the financing, Jeroen Bakker, Principal at Novo Seeds, will join the Board.

Commenting on the financing, Henrik Stage, Chief Executive Officer of Adcendo, said: "We are very pleased to welcome world-leading life sciences investor Novo Seeds to our board as a result of today’s financing and in recognition of its involvement in the company since inception. In the last few years, the ADC modality has delivered promising approvals of new drugs as well as significant commercial transactions. We are excited that we have secured this major financing from top tier investors and are looking forward to delivering on our vision of bringing new innovative treatments to cancer patients."

Jeroen Bakker, Principal at Novo Seeds, commented: "One of our ambitions at Novo Seeds is to leverage and nurture the untapped innovation in the Nordic region. We are proud to have been involved with Adcendo since its early days and are very impressed with the progress achieved to date. We are very pleased to now co-lead this investment with such an exceptional syndicate, building on the founders’ early-stage research at The Finsen Laboratory to develop Adcendo into a world leading ADC player, and we look forward to continuing playing a prominent role in shaping the Nordic biotech ecosystem."

uPARAP is a unique novel cancer target overexpressed on the cell surface of several cancers. Being a collagen scavenger receptor that possesses constitutively active and highly efficient internalization and recycling properties, it has been demonstrated to play a role in tumor invasion. The expression and biological mechanisms of uPARAP makes it ideal for an ADC approach as it may be used as a cancer-associated "drug internalization pump" to bring conjugated drugs directly into the cancer cells.

The uPARAP collagen scavenger receptor has been found to be overexpressed by cancer cells in several indications with high unmet needs including soft tissue sarcoma, glioblastoma multiforme, triple-negative breast cancers, leukemia and osteosarcoma, as well as by stromal cells in several high prevalence cancers with substantial stromal tissue content, such as prostate, breast and pancreatic cancer.

In addition to the uPARAP program, Adcendo will build a pipeline of additional novel cancer targets ideally suited to ADC approaches.

On April 29, 2021 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, reported that RADR has exceeded 4.6 billion datapoints (Press release, Lantern Pharma, APR 29, 2021, View Source;utm_medium=rss&utm_campaign=radr-surpasses-4-6-billion-datapoints-accelerating-progress [SID1234578775]). This 16-fold increase in datapoints over the past 12 months was also accompanied by other significant improvements in the functionality, feature-set and automation of the drug development platform as well as a significant increase in the number of drugs, drug classes and cancers covered by RADR.

"We are extremely pleased to share the fact that we have increased the number of biologically relevant and curated datapoints that power our RADR platform by 16-fold since last May and nearly 4-fold since the beginning of the year. The pace of data acquisition, curation, and tagging achieved during this last campaign is well ahead of schedule and allows us to increasingly focus on building a more complete and more powerful library of algorithms and machine learning models aimed at rapidly answering questions that are fundamental to oncology drug development," stated Panna Sharma, President and CEO of Lantern Pharma. "Our mission to build the world’s largest, most robust and most accurate A.I. driven platform for precision oncology drug discovery and development is advancing rapidly. The robustness of the datasets powering RADR is anticipated to continue to improve machine-learning results, accelerate automation of other features and aid oncology drug development for Lantern and our partners with the ultimate focus of benefitting cancer patients."

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Lantern is committed to growing and enhancing RADR, which it believes is among the largest drug development platforms powered exclusively for oncology drug development and rescue. The growing datapoints, and accompanying functionality in the A.I. platform, allow scientists, biologists, and engineers to collaborate on issues of drug activity, drug response, patient stratification, and cancer biomarkers at a pace which has been unachievable, until now. The developmental focus on increasing the number of datapoints, and improving the performance, power and biological relevance of the algorithms, is expected to yield additional targeted indications for Lantern’s current pipeline of drug candidates. We expect that the platform will also help in revealing additional compounds and therapies that can be in-licensed and subsequently developed in a more efficient, and potentially more targeted manner. Lantern has used RADR to uncover indications in multiple cancer sub-types, including CNS (central nervous system) cancers, drug-resistant lung cancers, lung cancer sub-types among never-smokers and SMARCB1 mutated cancers (e.g. Atypical Teratoid Rhabdoid Tumors).

Lantern has filed two additional patent applications directed to the RADR platform that further strengthen the Company’s leading position in using A.I. for cancer drug development and drug rescue. The Company’s patent applications are directed to using machine learning to predict and discover gene signatures associated with pharmaceutical agents, as well as using automated and machine learning methods on genomic and biomarker data for rescuing, repurposing and repositioning of pharmaceutical agents. Lantern expects to continue developing novel A.I. and machine learning functionality, methods and technologies that it will file patents on both as core technologies and directed in the use of its pipeline of drug candidates.

"As A.I. continues to transform drug development, platforms that can provide a machine-learning, A.I. driven edge are becoming an essential tool for companies to make informed, rapid decisions in cancer indication selection, trial design, validation of mechanisms and potential creation of combination therapy regimens," continued Sharma. "Now, with every major cancer and drug class being covered in our A.I. platform, Lantern can focus not only on accelerating our portfolio, but also on developing collaborations that continue to enhance and validate our platform while delivering insights for our biopharma partners. These RADR powered insights are expected to accelerate development timelines, derisk key decisions and uncover new opportunities that may have gone undeveloped — ultimately leading to oncology therapies that can increase the personalization of treatment."

"Biopharma companies are looking to launch programs in validated indications more rapidly as they focus on maximizing the potential of each drug candidate," said Mr. Sharma. "We believe that RADR can help design and launch these programs, that continue to grow in complexity, at a fraction of the cost and timeline of traditional oncology drug development. Creating novel genomic and mechanistic insights while also providing specific guidance on designing biomarker driven preclinical studies and clinical trials is an essential component of personalizing cancer treatment. RADR is a powerful platform that can offer a significant competitive advantage for oncology drug development."

On April 29, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the acceptance of an abstract discussing its pancreatic adenocarcinoma trial at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is taking place virtually from June 4 – 8, 2021 (Press release, Oncolytics Biotech, APR 29, 2021, View Source [SID1234578773]). Details on the abstract and a corresponding poster presentation are shown below.

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Title: Treatment with pembrolizumab in combination with the oncolytic virus pelareorep promotes anti-tumor immunity in patients with advanced pancreatic adenocarcinoma
Presentation Type: Electronic poster
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4144

The abstract will be published on the ASCO (Free ASCO Whitepaper) Annual Meeting website at 5:00 p.m. ET on May 19, 2021. The corresponding poster will be made available on the meeting website at 9:00 a.m. ET on June 4, 2021.