On November 4, 2020 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the third quarter ended September 30, 2020 and recent business highlights (Press release, Mirati, NOV 4, 2020, View Source [SID1234569894]).

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"The third quarter was notable for significant progress and we have begun the fourth quarter with positive momentum. At the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Therapeutics last week, we presented preliminary adagrasib (MRTX849) data across multiple tumors, which highlighted the potential for this exciting and differentiated program. We have completed enrollment in our Phase 2 potentially registration-enabling monotherapy trial in 2nd or 3rd line non-small cell lung cancer patients, which will enable our anticipated NDA filing to the FDA for accelerated approval in the second half of 2021." said Dr. Charles M. Baum, President and Chief Executive Officer at Mirati Therapeutics, Inc. "We presented the first preclinical data for MRTX1133, a potentially first in class, potent, selective and reversible inhibitor of KRAS G12D in both its active and inactive states. MRTX1133 demonstrated significant tumor regression in several preclinical tumor models, and we anticipate filing an IND in the first half of 2021. Our recent public offering provides the resources to accelerate and expand development across our pipeline, including sitravatinib, adagrasib, MRTX1133 and discovery programs, as we continue to build our organization, prepare for commercialization and strive to bring novel therapies to cancer patients and their families."

Recent Corporate Updates:

Adagrasib (MRTX849, KRAS G12C Selective Inhibitor)

Presented preliminary updated data in non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other solid tumors at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) virtual conference
Completed enrollment in the single-agent Phase 2 registrational arm in 2nd or 3rd line therapy in NSCLC
Announced clinical collaboration with Boehringer Ingelheim to study BI 1701963, a SOS1::pan-KRAS inhibitor, in combination with adagrasib
MRTX1133 (KRAS G12D Selective Inhibitor)

Reported initial preclinical data demonstrating significant tumor regression in several tumor models
Sitravatinib

Presented updated clinical results from Phase 2 clinical trial evaluating sitravatinib in combination with nivolumab (OPDIVO) in patients with advanced or metastatic urothelial carcinoma at the ESMO (Free ESMO Whitepaper) Virtual Congress
Enrollment is on-going in the Phase 3 SAPPHIRE clinical trial in combination with nivolumab (OPDIVO) in 2nd or 3rd line NSCLC patients
Operational Update

Ended the third quarter with $579.1 million in cash, cash equivalents, and short-term investments and, in addition, strengthened our balance sheet by completing a public offering of common stock on October 30, 2020 that provided estimated net proceeds of $879.7 million
Financial Results for the Third Quarter 2020

License and collaboration revenues for the three months ended September 30, 2020, were $11.4 million, and relate to a license agreement with ORIC Pharmaceuticals, Inc. ("ORIC") pursuant to which the Company granted to ORIC an exclusive, worldwide license to develop and commercialize the Company’s allosteric polycomb repressive complex 2 (PRC2) inhibitors for all indications. License and collaboration revenues for the nine months ended September 30, 2020 were $11.7 million and related primarily to the ORIC license transfer described above, as well as $0.3 million related to the manufacturing supply services agreement with BeiGene. License and collaboration revenues for the three and nine months ended September 30, 2019 were $1.0 million and $2.8 million, respectively, and relate to the manufacturing supply services agreement with BeiGene.

Research and development expenses for the third quarter of 2020 were $79.9 million, compared to $47.4 million for the same period in 2019. Research and development expenses for the nine months ended September 30, 2020 were $216.6 million, compared to $119.9 million for the same period in 2019. The increase in research and development expenses is due to an increase in expense associated with the development of adagrasib (MRTX849), MRTX1133, and other preclinical and early discovery activities, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expenses of $12.6 million during the third quarter of 2020, compared to $8.6 million for the same period in 2019, and $35.9 million during the nine months ended September 30, 2020, compared to $20.4 million for the same period in 2019.

General and administrative expenses for the third quarter of 2020 were $20.2 million, compared to $10.7 million for the same period in 2019. General and administrative expenses for the nine months ended September 30, 2020 were $58.1 million, compared to $30.3 million for the same period in 2019. The increase is due primarily to an increase in share-based compensation expense and an increase in employee-related expenses and professional service expense. The Company recognized general and administrative-related share-based compensation expenses of $9.2 million during the third quarter of 2020, compared to $6.5 million for the same period in 2019, and $28.2 million during the nine months ended September 30, 2020, compared to $18.4 million for the same period in 2019.

Net loss for the third quarter of 2020 was $87.3 million, or $1.96 per share basic and diluted, compared to net loss of $54.3 million, or $1.38 per share basic and diluted for the same period in 2019. Net loss for the nine months ended September 30, 2020 was $256.9 million, or $5.87 per share basic and diluted, compared to net loss of $140.9 million, or $3.83 per share basic and diluted for the same period in 2019.

Cash, cash equivalents, and short-term investments were $579.1 million at September 30, 2020.

On November 4, 2020 Lannett Company, Inc. (NYSE: LCI) reported financial results for its fiscal 2021 first quarter ended September 30, 2020 (Press release, Lannett, NOV 4, 2020, View Source [SID1234569893]).

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"We view our fiscal 2021 first quarter net sales of $126 million as a solid achievement, given our current competitive landscape and overall decline of total prescriptions related to the ongoing pandemic," said Tim Crew, chief executive officer of Lannett. "During the quarter, we fully implemented our cost reduction plan that we estimate will lower expenses by approximately $15 million, annually, and launched four new products, including Levothyroxine Sodium Tablets, a meaningful product for us. More recently, we began marketing two additional products, including the exclusive authorized generic of Tirosint (Levothyroxine Sodium Capsules), a medication that complements and expands our thyroid deficiency portfolio of products. Our plans include launching approximately seven more products over the balance of the current fiscal year. Based on the aforementioned, we are affirming our previous guidance for the fiscal 2021 full year.

"At the end of this month, we intend to use a portion of our existing cash to pay down, in full, our Term A Loans. This milestone will lower our annual interest expense and principal payments by approximately $30 million, thus improving our financial flexibility. Moreover, our remaining debt is free of financial covenants and the nearest maturity is in November of 2022, two years away.

"We continue to advance a number of drug candidates in our portfolio that we believe have durable value and the potential to be catalysts for significant growth. Our respiratory and biosimilar product candidates with large addressable markets remain on track, and we expect to expand such durable portfolio assets over the course of this fiscal year."

For the fiscal 2021 first quarter on a GAAP basis, net sales were $126.5 million compared with $127.3 million for the first quarter of fiscal 2020. Gross profit was $25.7 million, or 20% of net sales, compared with $42.7 million, or 33% of net sales. The company recorded restructuring expenses of $4.0 million compared with $1.4 million in the prior-year first quarter. Net loss was $6.5 million, or $0.17 per share, compared with $12.2 million, or $0.32 per share, for the first quarter of fiscal 2020.

For the fiscal 2021 first quarter reported on a Non-GAAP basis, net sales were $126.5 million compared with $127.3 million for the first quarter of fiscal 2020. Adjusted gross profit was $34.4 million, or 27% of net sales, compared with $52.6 million, or 41% of net sales, for the prior-year first quarter. Adjusted interest expense decreased to $11.2 million compared with $15.3 million for the first quarter of fiscal 2020. Adjusted net income was $2.2 million, or $0.06 per diluted share, compared with $8.8 million, or $0.22 per diluted share, for the fiscal 2020 first quarter. Adjusted EBITDA for the fiscal 2021 first quarter was $33.2 million.

Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 4:30 p.m. ET to review its results of operations for its fiscal 2021 first quarter ended September 30, 2020. The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 49992942. The call will be broadcast via the Internet at www.lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company’s financial status and performance, regulatory and operational developments, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including Adjusted EBITDA, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). Management uses these measures internally for evaluating its operating performance. The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. The company also believes that including Adjusted EBITDA, as defined in the company’s existing Credit Agreement, is appropriate to provide additional information to investors to demonstrate the company’s ability to comply with financial debt covenants. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP.

Detailed reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are included with this release.

Non-GAAP financial measures exclude, among others, the effects of (1) amortization of purchased intangibles and other purchase accounting entries, (2) restructuring expenses, (3) non-cash interest expense, as well as (4) certain other items considered unusual or non-recurring in nature.

Adjusted EBITDA excludes the same adjustments discussed above, as well as additional adjustments permitted under the company’s existing Credit Agreement.

On November 4, 2020 Centene Corporation (NYSE: CNC) reported it will participate at two virtual conferences this month (Press release, Centene , NOV 4, 2020, View Source [SID1234569892]).

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On Tuesday, November 10, at 8:45 a.m. Eastern Standard Time (EST), Centene will participate in a virtual format at the Credit Suisse 29th Annual Healthcare Conference. A simultaneous live audio webcast is available at: View Source

The following week, Centene will participate in a virtual format at the Bernstein Operational Decisions Conference on Monday, November 16, at 8:00 a.m. EST. A simultaneous live audio webcast is available at: View Source

Webcast replays will be available afterwards via the Company’s website at www.centene.com under the Investors section.

On November 4, 2020 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) reported its financial results for the third quarter ended September 30, 2020, and provided a corporate update (Press release, Protagonist, NOV 4, 2020, View Source [SID1234569891]).

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"The three clinical assets PTG-300, PN-943 and PTG-200, all discovered through our peptide technology platform, continue to make progress in Phase 2 clinical proof-of-concept studies," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "We look forward to sharing updated clinical data in December from our Phase 2 study of PTG-300 in patients with polycythemia vera and see significant opportunity for PTG-300 to address unmet needs and improve upon the current standards of care."

Dr. Patel continued, "We are moving forward with our ongoing Phase 2 clinical programs with the oral alpha-4-beta-7 integrin antagonist PN-943 in patients with ulcerative colitis, and the oral interleukin-23 receptor antagonist PTG-200 in patients with Crohn’s disease. In addition, we’re encouraged by the steady progress in our ongoing collaboration with Janssen, and recently announced the selection of two additional oral interleukin-23 receptor antagonists, PN-235 and PN-232, for advancement into clinical development. These candidates provide several strategic options for development in multiple indications."

Product Development and Corporate Update

PTG-300: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera and Other Blood Disorders

Five presentations have been accepted for the American Society for Hematology (ASH) (Free ASH Whitepaper) Annual meeting, taking place in a virtual format from December 5-8, 2020. Two posters and one oral presentation are related to PTG-300 and polycythemia vera and two posters describe the hepcidin mimetic mechanism of action and a hepcidin mimetic for oral delivery.
In October, PTG-300 was granted orphan designation by the European Medicines Agency for the treatment of polycythemia vera.
Complete enrollment of 50 patients in the PTG-300 polycythemia vera study is expected in mid-2021.
A pivotal study of PTG-300 in the treatment of polycythemia vera is expected to begin in the second half of 2021 pending dialog with regulatory authorities.
An open-label proof-of-concept study of PTG-300 in patients with hereditary hemochromatosis is in progress and results are expected in 2021.
PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory Bowel Disease

Protagonist has dosed patients in a global, randomized, double-blind, placebo-controlled Phase 2 study (the "IDEAL Study") evaluating safety, tolerability and efficacy of PN-943 in approximately 150 patients with moderate to severe ulcerative colitis.
In light of the global COVID-19 pandemic, Protagonist has suspended guidance on a timeline for study completion.
Oral IL-23 Receptor Antagonists (Janssen Biotech and Protagonist Collaboration)

Protagonist Therapeutics and Janssen Biotech are jointly conducting the development of PTG-200 (JNJ-67864238) through completion of a Phase 2 clinical proof of concept study in the treatment of Crohn’s disease.
Two additional oral peptide IL-23 receptor antagonist candidates from the collaboration agreement with Janssen Biotech, PN-235 (JNJ-77242113) and PN-232 (JNJ-75105186), have been selected for advancement into clinical development. A Phase 1 study of PN-235 is expected to begin in the fourth quarter of 2020.
Financial Update

During the third quarter of 2020, the Company issued 333,000 shares through its at-the-market (ATM) program and raised $6.4 million; shares were sold at an average price of $19.65 per share.
The Company also reported sales of an additional 918,000 shares through its ATM program during October 2020, raising $18.9 million, at an average price of $21.03 per share.
Financial Results

Cash, cash equivalents and marketable securities as of September 30, 2020, were $200.0 million. Protagonist estimates sufficient financial resources from its cash, cash equivalents, marketable securities and access to its debt facility to fund its currently planned operating and capital expenditures through mid-2023.
License and collaboration revenues were $13.1 million and $23.0 million for the three and nine months ended September 30, 2020, respectively, in comparison to $4.1 million and $(2.5) million reported for the same periods of 2019. The increase in revenue in the third quarter of 2020 compared to 2019 was related to an estimate update for services completed versus remaining services to be performed under the Janssen collaboration agreement. This revised estimate accelerated our overall performance percentage completion under the current accounting performance obligation, coupled with continued delivery of Protagonist’s services under the ongoing collaboration. The increase in year-over-year revenue was also related to a previously reported 2019 one-time cumulative adjustment related to the application of revenue recognition principles following the May 2019 amendment of the Janssen Biotech collaboration agreement that had reduced revenue by $9.4 million for the nine months ended September 30, 2019.
Research and Development (R&D) expenses for the three and nine months ended September 30, 2020, were $16.0 million and $55.0 million, respectively, as compared to $17.3 million and $49.1 million for the same periods of 2019. 2020 expenses were primarily related to advancing our clinical development including the ongoing Phase 2 clinical trial for polycythemia vera with PTG-300, PN-943 Phase 2 study in ulcerative colitis, and the IL-23 receptor antagonist research collaboration activities with Janssen Biotech.
General and Administrative (G&A) expenses for the three and nine months ended September 30, 2020, were $4.9 million and $13.6 million, respectively, as compared to $4.0 million and $11.6 million for the same periods of 2019. The increases were primarily related to professional fees, insurance costs and salary related expenses to support the growth in operations.
Net loss for the three and nine months ended September 30, 2020, was $7.8 million and $47.3 million or a net loss of $0.21 per share and $1.45 per share, respectively, as compared to a net loss of $16.4 million and $59.7 million, or a net loss of $0.61 per share and $2.36 per share, respectively, for the same periods of 2019.

On November 4, 2020 Amgen (NASDAQ:AMGN) reported that it will present at the 29th Annual Credit Suisse Virtual Healthcare Conference at 4:15 p.m. ET on Monday, Nov. 9, 2020, in Scottsdale, Ariz (Press release, Amgen, NOV 4, 2020, View Source [SID1234569890]). Murdo Gordon, executive vice president of Global Commercial Operations at Amgen and Peter H. Griffith, executive vice president and chief financial officer, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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