On August 5, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the second quarter of 2021 and recent corporate updates (Press release, Mirati, AUG 5, 2021, View Source [SID1234585893]).

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"We continue to aggressively advance our clinical and growing preclinical pipeline of oncology programs," said Charles M. Baum, M.D., Ph.D., president and chief executive officer, Mirati Therapeutics, Inc. "We achieved breakthrough therapy designation for adagrasib, and look forward to submitting the new drug application this year with the goal of extending and improving the lives of patients with non-small cell lung cancer who have a KRASG12C mutation."

"In addition, the sitravatinib registration trial in non-squamous non-small cell lung cancer is on track to read out an interim analysis of overall survival in the second half of 2022. Our potentially first-in-class preclinical programs in IND-enabling studies include KRASG12D inhibitor, MRTX1133, as well as a synthetic lethal PRMT5 inhibitor, MRTX1719, for which we expect to file an IND application by the end of 2021."

Pipeline Updates

Adagrasib

Announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to adagrasib. (View Release). The Company plans to present updated non-small cell lung cancer (NSCLC) data in the second half of 2021 and submit a New Drug Application (NDA) for adagrasib in the fourth quarter of 2021 for the potential treatment of patients with NSCLC who harbor the KRASG12C mutation following prior systemic therapy.

Plan to present new colorectal cancer (CRC) data at a medical conference in the second half of 2021 from the Phase 1/2 KRYSTAL-01 study evaluating adagrasib in combination with cetuximab1 (ERBITUX) in second-line patients with a KRASG12C mutation and as a monotherapy in patients who have received three or more lines of therapy.

Initiated KRYSTAL-014, a Phase 1/1b study evaluating the combination of adagrasib with Boehringer Ingelheim’s SOS1 inhibitor (BI 1701963) in patients with solid tumors that harbor the KRASG12C mutation.

Announced the Company entered into a collaboration and license agreement with Zai Lab for adagrasib in Greater China. (View Release)
Sitravatinib

Announced updated data will be presented at the 2021 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress from the Phase 2 MRTX-500 study evaluating sitravatinib plus nivolumab (OPDIVO)2 in patients with advanced NSCLC who had documented progression following treatment with checkpoint inhibitor therapy.

Plan to provide an update, based on an interim analysis of overall survival, from the Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab in second or third line non-squamous NSCLC in the second half of 2022; enrollment is ongoing.
Preclinical

Announced selection of clinical development candidate, MRTX1719, for investigational synthetic lethal MTA cooperative PRMT5 inhibitor in methylthioadenosine phosphorylase (MTAP)-deleted cancers. The Company expects to file an Investigational New Drug (IND) application for MRTX1719 by the end of 2021.

Announced the Company has an in-house discovery program targeting SOS1 in lead candidate optimization stage leveraging the target’s utility as a KRAS signaling modifier as a monotherapy or in combination with KRAS inhibitors.
Second Quarter 2021 Financial Results

Ended the second quarter with approximately $1.2 billion in cash, cash equivalents, and short-term investments, which does not include the upfront fee of $65 million from Zai Lab pursuant to the collaboration and license agreement executed during the quarter.

Research and development expenses for the second quarter of 2021 were $134.6 million, compared to $65.1 million for the same period in 2020. Research and development expenses for the six months ended June 30, 2021 were $238.6 million, compared to $136.8 million for the same period in 2020. The increase in research and development expenses is primarily due to an increase in expense associated with the development of adagrasib, an increase in preclinical and early discovery activities, as well as an increase in salaries and other employee-related expense, which includes an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expenses of $16.5 million during the second quarter of 2021, compared to $11.5 million for the same period in 2020, and $31.0 million during the six months ended June 30, 2021, compared to $23.3 million for the same period in 2020.

General and administrative expenses for the second quarter of 2021 were $29.6 million, compared to $19.8 million for the same period in 2020. General and administrative expenses for the six months ended June 30, 2021 were $58.0 million, compared to $37.8 million for the same period in 2020. The increase is primarily due to an increase in salaries and other employee-related expenses, an increase in insurance, rent and other facilities-related costs, and an increase in sponsorship agreements expense, and an increase in professional service expense. The Company recognized general and administrative-related share-based compensation expenses of $11.5 million in the second quarter of 2021, compared to $9.3 million for the same period in 2020, and $21.7 million during the six months ended June 30, 2021, compared to $19.0 million for the same period in 2020.

Net loss for the second quarter of 2021 was $166.4 million, or $3.23 per share basic and diluted, compared to a net loss of $82.9 million, or $1.89 per share basic and diluted for the same period in 2020. Net loss for the six months ended June 30, 2021 was $302.1 million, or $5.91 per share basic and diluted, compared to a net loss of $169.5 million, or $3.91 per share basic and diluted for the same period in 2020.

On August 5, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a fully-integrated clinical stage biotechnology company focused on discovering and developing novel, small molecule drugs for the treatment of cancer and other life-threatening diseases, reported its financial results for the second quarter ended June 30, 2021.

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"In the second quarter, we announced a license agreement with Antengene for the development of CB-708, a potential first-in-class oral small molecule CD73 inhibitor developed internally via our drug discovery engine," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "We continued to advance our two lead programs, telaglenastat in non-small cell lung cancer patients with KEAP1/NRF2 genetic mutations and CB-280 for the treatment of cystic fibrosis. In addition, interim data from the Phase 1b study of CB-280 has been accepted for presentation at the upcoming North American Cystic Fibrosis Conference. Further, in June, we became members of the Broad Institute’s Cancer Dependency Map (DepMap) Consortium. The goal of the DepMap initiative is to discover new targets and biomarkers for precision cancer medicines. Our membership in the Consortium will provide an opportunity for us to generate novel data for discovery programs and forge deeper collaborations with Broad’s data and computational scientists in order to enable translational decisions for our programs. We are pleased with our continued progress and believe the Company is poised to reach multiple important milestones in the coming quarters. We look forward to sharing our progress."

Second Quarter 2021 and Recent Highlights

Continued enrollment of the Phase 2 randomized KEAPSAKE trial in non-small cell lung cancer (NSCLC) patients with genetic mutation in KEAP1/NRF2. The double-blind KEAPSAKE trial is expected to enroll approximately 120 patients with stage IV non-squamous NSCLC with tumors that have a KEAP1 or NRF2 mutation. Patients are randomized to receive telaglenastat or placebo, in combination with pembrolizumab, carboplatin and pemetrexed. The study is evaluating the safety and investigator-assessed progression-free survival (PFS) of telaglenastat plus this standard-of-care chemoimmunotherapy regimen. Calithera anticipates releasing interim data from the KEAPSAKE trial in the fourth quarter of 2021.
Ongoing enrollment of the Phase 1b clinical trial of CB-280 in patients with cystic fibrosis (CF). CB-280 is a novel oral inhibitor of arginase, an enzyme that depletes the amino acid arginine. The randomized, double blind, placebo-controlled, dose escalation trial is evaluating multiple ascending doses of CB-280, dosed orally twice daily for 14 days, compared to placebo in up to 32 adult CF patients to determine a safe dose range for CB-280. In October 2020, Calithera was awarded up to $2.4 million from the Cystic Fibrosis Foundation to support clinical development of CB-280. Enrollment in the Phase 1b study is ongoing and Calithera plans to present interim data from this study at the 2021 North American Cystic Fibrosis Conference at the end of September.
Signed Worldwide License Agreement with Antengene for Development & Commercialization of CB-708. CB-708 is a highly potent, selective, orally-bioavailable small molecule inhibitor of CD73, which has demonstrated immune-mediated, single agent activity in syngeneic mouse tumor models. Under the agreement, Calithera received an upfront payment and may receive potential development, regulatory and sales milestones of up to $252.0 million. Additionally, Calithera is eligible to receive tiered royalties on sales of the licensed product up to low double-digits.

Final results of CANTATA presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. The Phase 2 CANTATA trial was a global, randomized, double-blind clinical trial of telaglenastat combined with cabozantinib, in patients with advanced or metastatic RCC who have received one or two prior treatments. On January 4, 2021, Calithera announced that the trial did not meet the primary endpoint of improving PFS. The complete dataset was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 7, 2021.
Selected Second Quarter 2021 Financial Results

Cash, cash equivalents and investments totaled $92.2 million at June 30, 2021.

Revenue was $3.0 million for the three months ended June 30, 2021 and represents revenue recognized in the second quarter from the company’s license agreement with Antengene.

Research and development expenses for the second quarter 2021 were $12.8 million, compared to $15.6 million in the same period prior year. The decrease of $2.8 million was primarily due to a $2.1 million decrease in the telaglenastat program and a $1.2 million decrease in the INCB001158 program, partially offset by increases in our CB-280 program and investments in early stage research.

General and administrative expenses for the second quarter 2021 were $4.5 million, compared to $5.1 million in the same period prior year. The decrease of $0.6 million was primarily related to decreases in professional services costs and in rent expense related to our facility lease amendment in March 2021.

Net loss for the three months ended June 30, 2021 was $14.3 million.

Conference Call Information

Calithera will host an update conference call today, Thursday, August 5, at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and referring to conference ID 4536305. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On August 5, 2021 Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) ("Merrimack" or the "Company") reported its second quarter 2021 financial results for the period ended June 30, 2021 (Press release, Merrimack, AUG 5, 2021, View Source [SID1234585891]).

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"We are pleased to report continued reductions in our operating expenses as well as positive overall cashflow during the quarter due to receipt of a tax refund," said Gary Crocker, Chairman of Merrimack’s Board of Directors. "Both Ipsen Pharmaceuticals and Elevation Oncology continue to report progress on separate clinical programs which could result in future milestone payments to Merrimack."

Second Quarter 2021 Financial Results

Merrimack reported net loss of $0.8 million for the second quarter ended June 30, 2021, or $0.06 per basic share, compared to a net loss of $1.2 million, or $0.09 per basic share, for the same period in 2020.

General and administrative expenses for the second quarter ended June 30, 2021 were $0.8 million, compared to $1.2 million for the same period in 2020.

As of June 30, 2021, Merrimack had cash and cash equivalents of $14.9 million, compared to $14.0 million as of December 31, 2020. The increase in cash position was due to a decrease of $1.8 million in prepaid expense and other assets related to the receipt of our federal tax refund in April 2021, as well as $0.2 million from the exercise of stock options.

As of June 30, 2021, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen Pharmaceuticals

On July 29, 2021, as part of its H1 2021 Results Presentation, Ipsen provided to the public an update on the RESILIENT trial of ONIVYDE as a second line treatment for Small Cell Lung Cancer, indicating that clinical data from this trial as well as a possible regulatory filing are anticipated in 2022. Ipsen also provided an update on the NAPOLI 3 trial of ONIVYDE as a first line treatment for pancreatic cancer. Enrollment is continuing in this trial and Ipsen indicated that clinical data as well as a possible regulatory filing are expected in 2023
Elevation Oncology

On June 24, 2021 Elevation Oncology announced the pricing of its initial public offering of 6,250,000 shares of its common stock at a public offering price of $16.00 per share, with gross proceeds to Elevation expected to be $100 million. The anti-HER3 program licensed from Merrimack continues to be Elevation’s lead clinical asset.

On August 5, 2021 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported second quarter 2021 financial results and provided a business update (Press release, NextCure, AUG 5, 2021, View Source [SID1234585890]).

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"We have made notable progress across all of our clinical programs including several enhancements to the ongoing NC318 Phase 2 monotherapy trial. Clinical sites can now select for S15+ patients, through screening biopsies in a CLIA certified laboratory. In addition, we have resumed enrolling non-small cell lung cancer (NSCLC) adenocarcinoma patients in the ongoing NC318 monotherapy trial and have revised the NC318 dosing regimen to increase overall drug exposure to NC318," said Michael Richman, NextCure’s president and chief executive officer. "We expect to provide a data update from our ongoing Phase 2 monotherapy trial of NC318, as well as to report Phase 1 data for NC410 by year-end. We have initiated clinical development of our third program, NC762 targeting B7-H4, with anticipated initial Phase 1 data mid-2022."

Business Highlights and Upcoming Milestones

NC318
Clinical Laboratory Improvement Amendments (CLIA) validated assay available for S15+ patient selection to effectively evaluate NC318 activity in patients with S15+ tumors.
Resumed enrollment of a non-small cell lung cancer (NSCLC) adenocarcinoma cohort in the ongoing Phase 2 monotherapy trial.
Revised dosing regimen to 800 mg weekly to increase overall drug exposure.
On track to report Phase 2 monotherapy update in the fourth quarter of 2021.
In the second quarter of 2021, Yale University commenced a Phase 2 investigator-initiated clinical trial of NC318 in combination with pembrolizumab in patients with advanced NSCLC with anticipated initial data in the first half of 2022.
NC410
Presented trial in progress poster at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting.
Published preclinical data demonstrating that NC410 promoted T cell mediated anti-tumor immunity, enhanced infiltration and increased localized activity of T cells in the tumor microenvironment.
On track to report initial clinical data in the fourth quarter of 2021.
NC762
Started the Phase 1 portion of a Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors.
Initial data anticipated to be available in mid-2022.
Financial Guidance

Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditure requirements into the second half of 2023.

Financial Results for Quarter Ended June 30, 2021

Cash, cash equivalents and marketable securities as of June 30, 2021 were $249.5 million, compared to $283.4 million as of December 31, 2020. The decrease of $33.9 million primarily reflects cash used to fund operations, cash used to purchase fixed assets, and repayments on a term loan.
Research and development expenses were $11.9 million for the quarter ended June 30, 2021, as compared to $11.1 million for the quarter ended June 30, 2020. The increase was driven primarily by clinical-related costs, partially offset by timing of clinical supply costs.
General and administrative expenses were $6.0 million for the quarter ended June 30, 2021, as compared to $4.7 million for the quarter ended June 30, 2020. The increase was driven primarily by personnel-related costs.
Net loss was $18.0 million for the quarter ended June 30, 2021, as compared to $14.5 million for the quarter ended June 30, 2020. The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount.
About NC318
NC318 is a first-in-class immunomedicine against S15, a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15. NextCure believes NC318 has the potential to treat multiple cancer types.

About NC410
NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and dendritic cells, a type of antigen presenting cell. In preclinical research, it was observed that LAIR-1 inhibited T cell function and dendritic cell activity allowing tumor cells to grow. In preclinical studies, NC410 blocked the negative effects of LAIR-1 and promoted T cell function and dendritic cell activity. NextCure believes NC410 has the potential to treat multiple cancer types.

About NC762
NC762 is a monoclonal antibody that binds specifically to B7-H4, a protein expressed on multiple tumor types. NextCure believes NC762 acts by inhibiting tumor cell growth and killing tumor cells, including by enhancing immune response. The company has observed in preclinical studies that NC762 inhibits the growth of human melanoma tumors in mice and believes that NC762 has the potential to treat multiple tumor types. NextCure’s research indicates that NC762 inhibits tumor cell growth independently of immune cell infiltration in the tumor microenvironment.

On August 5, 2021 Geron Corporation (Nasdaq: GERN) reported that it will release its second quarter and year to date 2021 financial results after the market closes on Monday, August 16, 2021 via press release, which will be available on the Company’s website at www.geron.com/investors (Press release, Geron, AUG 5, 2021, View Source [SID1234585889]). Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

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A live, listen-only webcast will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the conference call live via telephone by pre-registering online using the following link, View Source Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.