On November 1, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported financial results for the third quarter ended September 30, 2021 (Press release, Lantern Pharma, NOV 1, 2021, View Source [SID1234594007]).

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"Lantern has continued to advance our portfolio, both clinically and in new preclinical indications, as well as rapidly expand our RADR A.I. platform this past quarter," stated Panna Sharma, President & CEO of Lantern Pharma Inc. "Our A.I. driven approach to oncology drug development will be pivotal in discovering additional indications for our existing compounds, as well as the identification of entirely new drug candidates. Our strong balance sheet with over $73.8 million of cash, cash equivalents and marketable securities as of September 30, 2021 provides us with a solid foundation as we execute on our clinical programs and expand our proprietary RADR A.I. platform."

Third Quarter 2021 and Subsequent Highlights:

Achieved over 10 billion data points from highly curated oncology datasets focused on increasing the performance and scale of our A.I. platform, RADR, for oncology drug development
LP-184 granted Orphan Drug Designation for the treatment of glioblastoma multiforme (GBM) and other malignant gliomas by the U.S. Food and Drug Administration (FDA)
Announced positive preclinical data in glioblastoma with LP-184 and expanded GBM research collaboration with Johns Hopkins University
LP-184 granted Orphan Drug Designation for the treatment of pancreatic cancer by the FDA
Submitted poster presentation on the effectiveness of LP-184 in pancreatic cancers, which was accepted for presentation at the AACR (Free AACR Whitepaper) Virtual Special Conference: Pancreatic Cancer
Presented positive preclinical data for LP-184 in pancreatic cancers that have either high levels of PTGR1 expression or deficiencies/mutations in DNA damage repair genes
Confirmed LP-184 efficacy in the nanomolar range in the ultra-rare brain cancer, Atypical Teratoid Rhabdoid Tumor (ATRT), using animal models
Advanced two new undisclosed programs focused on rare cancers which are expected to advance into preclinical indications during 2022
Entered strategic collaboration with Deep Lens to accelerate patient enrollment for Lantern’s planned Phase 2 clinical trial for never-smokers with non-small cell lung cancer (NSCLC), utilizing LP-300 in combination with chemotherapy
Entered into a strategic collaboration with Code Ocean to facilitate the accelerated development of RADR both internally and with external collaborators while reducing development complexity and cost and increasing security and reproducibility
"We continue to advance our pipeline of drug candidates and made significant progress across multiple areas of our business during the third quarter," commented Panna Sharma, President and CEO of Lantern Pharma. "Specifically, we reported positive preclinical data for LP-184 in pancreatic cancer and GBM. LP-184 demonstrated remarkable efficacy, in both in vivo and ex vivo models, validating the in-silico predictions generated by our RADR A.I. platform. Based upon our highly encouraging preclinical data, the FDA granted LP-184 Orphan Drug Designations for the treatment of pancreatic cancer and glioblastoma multiforme and other malignant gliomas. Our plan is to develop LP-184 for a number of targeted oncology indications where we can exploit the important mechanistic insights we have obtained about the compound."

"Earlier today, we announced that our proprietary A.I. platform, RADR, has now surpassed 10 billion datapoints powered by a growing library of algorithms designed specifically to help solve challenging data and correlation problems in cancer drug development. This directly advances our stated goal of building the world’s largest A.I. platform for precision oncology drug development. Our RADR platform will be pivotal in uncovering potential new therapeutic opportunities for Lantern and developing insights into the creation of combination-therapy programs, both internally and through third-party collaborations to drive long-term shareholder value. Our goal is to expand RADR to over 20+ billion datapoints during 2022. This will not only open more opportunities for collaborations with additional biopharma partners, but will also dramatically accelerate development timelines, derisk key decisions and reveal new opportunities that may have gone undeveloped — ultimately leading to additional therapeutic opportunities for patients and additional sources of value for our investors. By advancing our clinical pipeline, cultivating new discoveries, and growing our RADR platform, we believe we have laid the groundwork for numerous upcoming catalysts in the quarters and years ahead. "

Anticipated Upcoming Milestones:

Lantern Pharma to host virtual Key Opinion Leader (KOL) event on LP-184 for the treatment of pancreatic cancer with Dr. Igor Astsaturov, an established, NCI -funded, physician scientist and co-leader of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center and Dr. Kishor G. Bhatia, Chief Scientific Officer of Lantern Pharma on November 18th, 2021, World Pancreatic Cancer Day
Planned launch of 90 patient Phase 2 clinical trial in the US for LP-300 in NSCLC focused on never-smokers that are chemo naïve and failed/relapsed on TKI therapy
Share detailed scientific results from LP-184 collaborative research program in GBM after presentation at Society of Neuro Oncology conference November 18-21 in Boston, MA
Share results from other studies and preclinical work with LP-184 in pancreatic, bladder, GBM, ATRT and other tumors over the next several months
Launch Phase 1 clinical trial for LP-184 in solid tumors
Launch Phase 1/2 clinical trial for LP-184 in GBM
Progress LP-184 in ATRT towards Phase 1/2 clinical trial
Launch IND enabling studies for ADC program
Explore potential combinations for LP-184 and LP-300 with other existing approved drugs for additional targeted cancer indications
Strategically grow RADR A.I. platform to 20 billion datapoints, including continued expansion in blood cancers and additional rare cancers under review by our development team
Explore biopharma licensing and partnership opportunities
Third Quarter 2021 Financial Highlights:

Balance Sheet: Cash, cash equivalents, and marketable securities were $73.8 million as of September 30, 2021, compared to $19.2 million as of December 31, 2020.
R&D Expenses: Research and development expenses were $2.96 million for the three months ended September 30, 2021, compared to $0.6 million for the three months ended September 30, 2020. The increase was primarily attributable to increased manufacturing related expenses and expenditures to advance and expand the Company’s product portfolio.
G&A Expenses: General and administrative expenses were $1.2 million for the three months ended September 30, 2021, compared to $1.1 million for the three months ended September 30, 2020. The nominal increase was primarily attributable to increased business and corporate development expenses, legal and patent related fees, and general and administrative related stock option expenses.
Net Loss: Net loss was $4.1 million for the three months ended September 30, 2021, compared to a net loss of $1.7 million for the three months ended September 30, 2020.
A copy of the Company’s quarterly report on Form 10-Q for the third quarter ended September 30, 2021 has been filed with the Securities and Exchange Commission and posted on the Company’s website at View Source

Conference Call & Webcast:
Monday, November 1, 2021 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time

To register for the live webcast, please sign up here: View Source
To access the conference by phone: One-tap dial-in: +19292056099,,99145071949#
A replay of the conference call will be available on the investor relations section of the Company’s website: ir.lanternpharma.com

On November 1, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the third quarter ended September 30, 2021 (Press release, Neurocrine Biosciences, NOV 1, 2021, View Source [SID1234594006]).

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"Our third quarter results reflect INGREZZA’s continued growth. With this momentum and increased investment to expand our commercial footprint, we can better serve patients and our customers, and significantly improve diagnosis and treatment rates for people living with tardive dyskinesia," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We are prudently investing in our advancing and growing R&D pipeline. With important clinical data read-outs expected over the next two years, we are executing well on our strategy to become a leading neuroscience-focused company."

Third Quarter INGREZZA Net Product Sales and Commercial Highlights:

Net product sales for the third quarter of 2021 were $287 million and $285 million on an inventory adjusted basis
Record total prescriptions achieved during the third quarter 2021 reflecting higher customer demand and increased commercial activities
New prescriptions increased throughout the third quarter, reaching their highest levels since March 2020
Expanding commercial organization in 2022 to establish dedicated field teams to better meet the needs of healthcare professionals across diverse sites of care and help more patients access effective treatment more quickly
Financial Highlights:

Third quarter 2021 GAAP net income and diluted earnings per share were approximately $23 million and $0.23, respectively, compared with a net loss and net loss per share of approximately $58 million and $0.62, respectively, in the third quarter of 2020
Third quarter 2021 non-GAAP net income and diluted earnings per share were approximately $63 million and $0.64, respectively, compared with a net loss and net loss per share of approximately $17 million and $0.18, respectively, in the third quarter of 2020
Difference between third quarter 2021 GAAP and non-GAAP net income and diluted earnings per share compared with the third quarter of 2020 were driven by:
Prior year In-Process Research and Development (IPR&D) associated with $118.5 million of upfront fees paid pursuant to our exclusive license agreement with Takeda Pharmaceutical Company Limited (Takeda)
Increased R&D expense primarily due to increased investment to support advancing our pipeline programs, including our psychiatry programs in-licensed in mid-2020 and advancement of our in-licensed epilepsy programs which began at the end of 2019
Increased SG&A expense primarily due to increased investment in commercial initiatives including the launch of our INGREZZA direct-to-consumer advertising campaign, "TD Spotlight"
Third quarter 2021 provision for income taxes was approximately $8 million, compared with approximately $1 million in the third quarter of 2020. In the first quarter of 2021, the Company began recording a provision for income taxes using an effective tax rate approximating federal and state statutory rates. Due to the Company’s ability to offset its pre-tax income against previously benefited federal net operating losses, no federal cash tax is expected in 2021
At September 30, 2021, the Company had cash, cash equivalents and debt securities available-for-sale of approximately $1.3 billion
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

Recent Events

In August 2021, the Company announced plans to initiate registrational studies in the second half of 2021 with valbenazine for adjunctive treatment in schizophrenia and for dyskinesia due to cerebral palsy
In September 2021, the Company received approval of a clinical trial application (CTA) submitted in the European Union for NBI-921352 for the treatment of focal-onset seizures in adults. In connection with the approval, the Company paid Xenon a $10 million milestone, of which the Company expensed $5.4 million as R&D in the third quarter of 2021, and purchased an additional $4.6 million of Xenon’s common stock
Previously, the Company expected combined GAAP R&D and SG&A expenses in the range of $855 million to $905 million and Non-GAAP R&D and SG&A expenses in the range of $720 million to $770 million.
GAAP expense guidance range includes $10 million of IPR&D and milestone expenses, and approximately $135 million of share-based compensation, including increased share-based compensation for an equity grant to full-time employees other than executive officers in September 2021.

Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On November 1, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in Bernstein’s Second Annual Operational Decisions Conference on Thursday, Nov. 4, 2021 (Press release, Eli Lilly, NOV 1, 2021, View Source [SID1234594005]). Jake Van Naarden, CEO of Loxo Oncology at Lilly and president of Lilly Oncology; Mark Mintun, senior vice president, research and development – neuroscience, and president, Avid Radiopharmaceuticals; and Jamie Croaning, global development leader – tirzepatide, will participate in a virtual fireside chat at 12:30 p.m., Eastern time .

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On November 1, 2021 GT Biopharma Presented its Corporate Presentation (Presentation, GT Biopharma, NOV 1, 2021, View Source [SID1234594004]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On November 1, 2021 Incyte (Nasdaq:INCY) reported that multiple abstracts highlighting data from its oncology portfolio will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, held from November 10-14, 2021 in Washington, D.C and virtually (Press release, Incyte, NOV 1, 2021, View Source [SID1234594002]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We look forward to presenting data from multiple programs within Incyte’s immuno-oncology portfolio at this year’s SITC (Free SITC Whitepaper) conference," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology, Incyte. "Data being presented from the retifanlimab POD1UM clinical program, including a late-breaking poster presentation highlighting results from the POD1UM-101 study; as well as results from a Phase 1 study evaluating an oral PD-L1 inhibitor in immune-checkpoint naïve patients with advanced solid tumors, demonstrate our commitment to addressing the needs of patients with historically difficult-to-treat cancers."

Key abstracts include:

Late-Breaking Poster Presentation

Retifanlimab (INCMGA00012) in patients with recurrent MSI-H or dMMR endometrial cancer: Results from the POD1UM-101 Study (Abstract #956. Saturday, November 13, 7:00 a.m. – 8:30 p.m. ET)

Oral Presentation

Phase 1 study of INCB086550, an oral PD-L1 inhibitor, in immune-checkpoint naive patients with advanced solid tumors (Abstract #529. Session: Concurrent Rapid Oral Abstract Presentation: Clinical. Saturday, November 13, 12:45 – 1:45 p.m. ET)

Poster Presentation

A Phase 2 Study of Retifanlimab in Patients With Advanced or Metastatic Merkel Cell Carcinoma (MCC) (POD1UM-201) (Abstract #545. Friday, November 12, 7:00 a.m. – 8:30 p.m. ET)

Full abstracts will be available on the SITC (Free SITC Whitepaper) website and in the Journal for ImmunoTherapy of Cancer (JITC) on November 9, 2021. More information regarding the conference is available on the SITC (Free SITC Whitepaper) website: View Source

Conference Call and Webcast

Incyte will host an analyst and investor conference call and webcast on Saturday, November 13, 2021 from 6:30 – 7:30 p.m. ET to discuss its oral PD-L1 clinical development program, including data from INCB86550 which has been accepted for oral presentation at the SITC (Free SITC Whitepaper) Annual Congress.

The live and archived webcast will be available via investor.incyte.com.

To access the conference call, please dial 877-407-3042 for domestic callers or +1-201-389-0864 for international callers (conference identification number 13724808). If you are unable to participate, a replay will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is +1-201-612-7415 (conference identification number 13724808).