On August 5, 2021 Sanofi and Regeneron reported that it’s PD-1 inhibitor Libtayo in combination with platinum-doublet chemotherapy was stopped early after meeting its overall survival (OS) primary endpoint in patients with advanced non-small cell lung cancer (NSCLC) (Press release, Sanofi, AUG 5, 2021, View Source [SID1234585896]). Adding Libtayo to chemotherapy significantly improved OS, compared to chemotherapy alone, in the trial that enrolled patients with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels . These data are planned to form the basis of regulatory submissions in the U.S. and European Union.

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"Libtayo in combination with chemotherapy increased median overall survival to 22 months in patients with advanced non-small cell lung cancer, compared to 13 months with chemotherapy alone," said Miranda Gogishvili, M.D., an oncologist at the High Technology Medical Center, University Clinic, in Tbilisi, Georgia and a trial investigator. "Notably, the Phase 3 trial enrolled patients with a variety of challenging-to-treat disease characteristics, as well as those with locally advanced disease. These data add to the growing body of evidence supporting Libtayo in advanced non-small cell lung cancer, which also include the pivotal results for Libtayo monotherapy in cases of high PD-L1 expression."

The decision to stop the trial early was based on a recommendation by the Independent Data Monitoring Committee (IDMC) during a protocol-specified interim analysis. In this top-line initial analysis of 466 patients, combining Libtayo with chemotherapy reduced the risk of death by 29% compared to chemotherapy alone (hazard ratio: 0.71; 95% confidence interval [CI]: 0.53-0.93; p=0.014). Median OS was 22 months (95% CI: 16 months to not evaluable) for Libtayo and chemotherapy, and 13 months (95% CI: 12 to 16 months) for chemotherapy alone. No new Libtayo safety signals were identified in the IDMC analysis, and additional detailed efficacy and safety data will be presented at an upcoming medical meeting.

Lung cancer is the leading cause of cancer death worldwide. In 2020, an estimated 2.2 million and 225,000 new cases were diagnosed globally and in the U.S., respectively. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages. While PD-1 inhibitor monotherapy has primarily advanced the treatment of NSCLC with ≥50% PD-L1 expression, approximately 70% of all NSCLC cases will have <50% PD-L1 expression, making it the most common treatment setting.

The use of Libtayo in combination with chemotherapy for advanced NSCLC is currently under clinical investigation, and its safety and efficacy have not been fully evaluated by any regulatory authority.

About the Phase 3 Trial

The randomized, multicenter Phase 3 trial, called EMPOWER-Lung 3, investigated a first-line combination treatment of Libtayo and platinum-doublet chemotherapy, compared to platinum-doublet chemotherapy alone, in squamous or non-squamous advanced NSCLC irrespective of PD-L1 expression. Specifically, the trial included 466 patients who tested negative for ALK, EGFR and ROS1 mutations and had either previously untreated metastatic NSCLC (stage IV) or locally advanced NSCLC (stage IIIB/C) and were not candidates for definitive chemoradiation.

Patients were randomized 2:1 to receive either Libtayo 350 mg (n=312) or placebo (n=154) administered intravenously every three weeks for 108 weeks, plus platinum-doublet chemotherapy administered every three weeks for four cycles. The co-primary endpoints were OS and progression-free survival, and key secondary endpoints included objective response rate and best overall response.

Among trial patients, 30% (n=139) had tumors with <1% PD-L1 expression, 38% (n=175) had tumors with 1% to 49% PD-L1 expression, and 33% (n=152) had tumors with ≥50% PD-L1 expression.

About Libtayo

Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

The generic name for Libtayo in its approved U.S. indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA. Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in advanced cervical cancer, as well as in trials combining Libtayo with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

On August 5, 2021 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the second quarter ended June 30, 2021 (Press release, Checkpoint Therapeutics, AUG 5, 2021, View Source [SID1234585895]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, stated, "In the second quarter of 2021, we were pleased to announce the completion of enrollment in our pivotal cohort of patients with metastatic cutaneous squamous cell carcinoma ("cSCC") in our ongoing registration-enabling clinical trial for cosibelimab, our potential best-in-class anti-PD-L1 antibody product candidate, and continue to expect to report top-line data in the fourth quarter of this year. Upon a successful outcome, Checkpoint intends to submit a Biologics License Application ("BLA") for cosibelimab in 2022, followed shortly thereafter by a Marketing Authorization Application submission in Europe. With a potential favorable safety profile and a plan to commercialize at a substantially lower price than currently available therapies in this drug class, we believe cosibelimab could be a disruptive product in the $25 billion and growing PD-(L)1 market."

Mr. Oliviero continued, "Additionally, during the second quarter, we had productive interactions with the FDA regarding our development program for olafertinib (formerly CK-101), our third-generation epidermal growth factor receptor ("EGFR") inhibitor being evaluated by our partner in an ongoing double-blind, randomized Phase 3 study in China. We intend to utilize the Phase 3 study, if successful, to support a New Drug Application ("NDA") submission for olafertinib as a potential first-line treatment for patients with non-small cell lung cancer whose tumors have certain types of EGFR mutations."

Financial Results:

Cash Position: As of June 30, 2021, Checkpoint’s cash and cash equivalents totaled $65.1 million, compared to $60.0 million at March 31, 2021 and $40.8 million at December 31, 2020, an increase of $5.1 million for the quarter and an increase of $24.3 million for the first half of 2021.
R&D Expenses: Research and development expenses for the second quarter of 2021 were $7.2 million, compared to $3.0 million for the second quarter of 2020, an increase of $4.2 million. The increase in research and development expense is primarily attributable to an increase in clinical trial and manufacturing related expenses for cosibelimab. Research and development expenses for the second quarters of 2021 and 2020 each included $0.2 million of non-cash stock expenses.
G&A Expenses: General and administrative expenses for the second quarter of 2021 were $2.1 million, compared to $1.7 million for the second quarter of 2020, an increase of $0.4 million. General and administrative expenses for the second quarter of 2021 included $0.9 million of non-cash stock expenses, compared to $0.7 million for the second quarter of 2020.
Net Loss: Net loss attributable to common stockholders for the second quarter of 2021 was $9.1 million, or $0.12 per share, compared to a net loss of $4.6 million, or $0.09 per share, in the second quarter of 2020. Net loss for the second quarter of 2021 included $1.0 million of non-cash stock expenses, compared to $0.8 million for the second quarter of 2020.

On August 5, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported recent business highlights, anticipated upcoming milestones, and financial results for the second quarter and six months ended June 30, 2021 (Press release, BeiGene, AUG 5, 2021, View Source [SID1234585894]).

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"We continued executing on our key strategic objectives during the second quarter and took steps to further position BeiGene to become highly impactful to oncology patients worldwide"

"We continued executing on our key strategic objectives during the second quarter and took steps to further position BeiGene to become highly impactful to oncology patients worldwide," said John V. Oyler, Co-Founder, Chairman and Chief Executive Officer of BeiGene. "We are broadening global access to our medicines through approvals of five new indications and two new products in China as well as additional marketing approvals and commercialization for BRUKINSA in Chile, UAE, and Israel, new regulatory submissions for BRUKINSA in multiple geographies, and the advancement of our internally developed and in-licensed product candidates. Three key pipeline achievements include: first, continued clinical evidence for the best-in-class potential of BRUKINSA, as demonstrated by the results of the global SEQUOIA and ALPINE trials, which both had positive readouts at the interim for efficacy outcomes as well as safety consistent with what we have observed in its global development program with more than 2,300 patients treated to date; second, the expanded list of indications for tislelizumab in China, reflecting its potential for reimbursement in China and the potential for regulatory filings in other geographies across the globe; and third, progress with our differentiated Phase 3 stage, anti-TIGIT antibody, ociperlimab, which we believe is one of the most advanced anti-TIGIT molecules in development worldwide. We also continued to build key strategic capabilities in house including our research, clinical development, commercial and manufacturing infrastructure, including our plans to establish a U.S. commercial-stage manufacturing and clinical R&D site. We remain on track in our mission of bringing innovative and accessible medicines to billions more patients around the world."

Recent Business Highlights and Upcoming Milestones

Commercial Operations

Product sales grew due to continued progress of our product launches, with sales of BRUKINSA in the United States continuing to accelerate, and sales in China delivering significantly increased patient demand in the first full quarter following the inclusion of tislelizumab, BRUKINSA, and XGEVA on the National Reimbursement Drug List (NRDL), which became effective on March 1, 2021; and
Inclusion in the NRDL led to significant increases in the number of formal hospital listings for tislelizumab, BRUKINSA, and XGEVA in the second quarter of 2021 to approximately 13x, 28x, and 23x versus their respective levels prior to NRDL inclusion.
Development Programs

BRUKINSA (zanubrutinib), a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects, approved in the United States, China, Canada, and other international markets in selected indications and under development for additional approvals globally.

Received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy;
Received acceptance of a supplemental new drug application (sNDA) and was granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. The Prescription Drug User Fee Act (PDUFA) date is September 19, 2021;
Received approval by Health Canada for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy;
Continued to advance BRUKINSA in new markets. BRUKINSA is now commercially available in Chile, Israel, and UAE for patients with MCL who have received at least one prior therapy. To date, more than 30 marketing authorization applications in multiple indications have been submitted covering the United States, the European Union (EU), and more than 20 other countries or regions. In the quarter, five marketing applications for zanubrutinib were accepted for review by health authorities;
Included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for patients with both treatment naïve and relapsed or refractory (R/R) WM as a Category 1A preferred treatment option. BRUKINSA is not approved in this indication outside of China and Canada;
Announced positive topline interim results from the Phase 3 SEQUOIA trial (NCT03336333) comparing BRUKINSA to bendamustine and rituximab (B+R) in patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose tumor did not exhibit the deletion of chromosome 17p13.1 (del[17p]). The SEQUOIA trial met the primary endpoint of progression-free survival (PFS) as assessed by independent review committee (IRC), as BRUKINSA achieved a statistically significant improvement in PFS compared to B+R. BRUKINSA was also generally well-tolerated, consistent with its known safety profile;
Reported positive interim results from the Phase 3 ALPINE trial (NCT03734016) at the 26th European Hematology Association (EHA) (Free EHA Whitepaper) 2021 (EHA2021) Virtual Congress. Results from the ALPINE trial comparing BRUKINSA to ibrutinib in adult patients with relapsed or refractory (R/R) CLL or SLL demonstrated superiority in the primary endpoint of investigator-assessed overall response rate (ORR), and superiority in a key secondary endpoint of atrial fibrillation or flutter;
Additional data reported at EHA (Free EHA Whitepaper)2021 included:
Thirty-five month follow-up results from the pivotal Phase 2 trial (NCT03206970) in patients with R/R MCL; and
Thirty-four month follow-up results from the pivotal Phase 2 trial (NCT03206918) in patients with R/R CLL or SLL; and
Completed enrollment in the Phase 2 global ROSEWOOD trial (NCT03332017) in combination with obinutuzumab versus obinutuzumab alone in patients with R/R follicular lymphoma.
Expected Milestones for BRUKINSA

Receive approvals in the U.S. for patients with MZL who have received at least one prior anti-CD20-based therapy and for patients with WM in 2021. Additional continued expansion of BRUKINSA’s registration program is expected globally in new geographies and indications, including potential approvals in 2021 for certain patients with MCL in the Middle East, South America, Australia, and Russia; and with WM in the EU and Australia;
Report interim results from the Phase 3 SEQUOIA trial (NCT03336333) comparing BRUKINSA with bendamustine plus rituximab in patients with TN CLL or SLL at an upcoming major medical conference in 2021; and
Report additional results from the Phase 3 ALPINE trial (NCT03734016) in 2022.
Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages; approved in China in selected indications and under development for additional approvals globally.

Received approval by the NMPA for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC);
Received conditional approval by the NMPA for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with at least one systemic therapy;
Received acceptance of a supplemental Biologics License Application (sBLA) by the Center for Drug Evaluation (CDE) of the NMPA for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy;
Received acceptance of an sBLA by the CDE for the treatment of patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors; the application has been granted priority review;
Reported that the Phase 3 RATIONALE 309 trial (NCT03924986) of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC) met its primary endpoint of PFS at the interim analysis;
Presented long-term follow-up results from the pivotal Phase 2 trial (NCT03209973) in patients in China with R/R classical Hodgkin’s lymphoma (cHL) in an oral session at the EHA (Free EHA Whitepaper)2021 Virtual Congress;
Reported data in two poster presentations at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO2021):
Primary results of the global Phase 3 RATIONALE 302 trial (NCT03430843) of tislelizumab versus chemotherapy in patients with previously treated advanced or metastatic ESCC; and
Results from the pivotal Phase 2 trial (NCT03736889) in patients with previously treated, locally advanced unresectable or metastatic MSI-H or dMMR solid tumors; and
Completed enrollment in the Phase 3 trial (NCT03957590) of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC.
Expected Milestones for Tislelizumab

Submit the first biologics license applications (BLA) outside of China in 2021, in collaboration with Novartis; and
Submit an sBLA to the CDE of tislelizumab in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic NPC in 2021.
Pamiparib, a selective small molecule inhibitor of PARP1 and PARP2 conditionally approved in China for the treatment of patients with germline BRCA mutation-associated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.

Received conditional approval from the NMPA for the treatment of patients with gBRCA mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy. BeiGene has now launched pamiparib in China;
Reported data at ASCO (Free ASCO Whitepaper)2021 in two poster presentations:
Results from the Phase 2 trial (NCT03575065) in patients with locally advanced or metastatic HER2-negative breast cancer with deleterious or suspected deleterious gBRCA1/2m, who received no more than two prior lines of chemotherapy; and
Results from the Phase 2 PARALLEL 303 trial (NCT03427814) of pamiparib versus placebo as maintenance therapy in patients with inoperable locally advanced or metastatic gastric cancer that responded to platinum-based first-line chemotherapy.
Expected Milestones for Pamiparib

Report topline results from the Phase 3 trial (NCT03519230) of pamiparib as a maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer in 2021 or the first half of 2022.
Ociperlimab (BGB-A1217), an investigational anti-TIGIT monoclonal antibody with competent Fc function

Initiated patient enrollment in the following trials:
The Phase 3 AdvanTig-301 trial (NCT04866017) of ociperlimab in combination with tislelizumab versus durvalumab when co-administered with concurrent chemoradiotherapy (cCRT) in previously untreated, locally advanced, unresectable NSCLC;
The Phase 3 AdvanTIG-302 trial (NCT04746924) of ociperlimab in combination tislelizumab for the first-line treatment of patients with locally advanced, unresectable, or metastatic NSCLC whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations; and
The Phase 2 AdvanTIG-204 trial (NCT04952597) of ociperlimab in combination with tislelizumab plus chemoradiotherapy in patients with untreated limited-stage small cell lung cancer;
Presented clinical data at ASCO (Free ASCO Whitepaper)2021 on the Phase 1 dose-escalation study (NCT04047862) of ociperlimab in combination with tislelizumab in patients with advanced solid tumors.
BGB-11417, an investigational BCL-2 inhibitor

Reported preliminary results from the dose-escalation portion of a first-in-human Phase 1 trial (NCT04277637) in patients with R/R non-Hodgkin’s lymphoma (NHL) at EHA (Free EHA Whitepaper)2021;
Initiated patient enrollment in the following trials:
The zanubrutinib combination arm of the Phase 1 clinical trial (NCT04277637) in adult patients with mature B-cell malignancies;
The Phase 1 clinical trial (NCT04883957) of BGB-11417 in adult patients with mature B-cell malignancies in China; and
The Phase 1 trial (NCT04771130) of BGB-11417 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Expected Milestones for BGB-11417

Begin patient enrollment in a Phase 1 trial in patients with multiple myeloma with t(11;14) translocation in 2021.
Early-Stage Programs

Continued to advance our early-stage clinical pipeline of internally developed product candidates at dose escalation stage, including BGB-A445 (an investigational non-ligand competing OX40 monoclonal antibody as monotherapy or in combination with tislelizumab in solid tumors), BGB-15025 (an investigational hematopoietic progenitor kinase 1 (HPK1) inhibitor as monotherapy or in combination with tislelizumab in solid tumors), and BGB-10188 (an investigational PI3Kδ inhibitor as monotherapy or in combination with BRUKINSA in hematology malignancies, or in combination with tislelizumab in solid tumors).
Expected Milestones for Early-Stage Programs

Initiate the Phase 2 portion of the Phase 1/2 trial (NCT03744468) of BGB-A425 (an investigational TIM3 monoclonal antibody) in combination with tislelizumab in the second half of 2021.
Collaboration with Amgen

Received conditional approval in China of KYPROLIS (carfilzomib) for injection in combination with dexamethasone for the treatment of adult patients with R/R multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent. This is the first approval for KYPROLIS in China.
Other Collaboration Programs

Sitravatinib, an investigational tyrosine kinase inhibitor of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET, licensed from Mirati Therapeutics Inc. (Mirati), in Asia (excluding Japan), Australia, and New Zealand.

Initiated patient enrollment in the Phase 3 trial (NCT04921358) of sitravatinib in combination with tislelizumab in squamous and non-squamous NSCLC.
Manufacturing Operations

Announced plans to build a new commercial-stage manufacturing and clinical R&D campus at Princeton West Innovation Park in Hopewell, New Jersey. BeiGene has entered into a purchase agreement to acquire an approximately 42-acre site with over one million square feet of developable real estate to build a state-of-the-art facility and expand our footprint in this region. This planned campus is subject to the closing of this transaction and local approvals, and construction is expected to be completed in 2023; and
Began construction on a new small molecule manufacturing campus in Suzhou, China. The planned total area for the new campus will be 82,000 square meters, with construction expected to be complete in 2023. Once complete, the total production capacity is expected to increase BeiGene’s small molecule manufacturing capability in China by up to 10 times the current capacity, with an expected annual capacity of one billion tablets/capsules for solid preparations.
COVID-19 Impact and Response

The Company expects that the worldwide health crisis of COVID-19 will continue to have a negative impact on its operations, including commercial sales, regulatory interactions, inspections, filings, and clinical trial recruitment, participation, and data read outs. There remains uncertainty regarding the future impact of the pandemic globally. The Company is striving to minimize delays and disruptions, and continues to execute on its commercial, regulatory, manufacturing, and clinical development goals globally.
Corporate Developments

The Listing Committee of the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange approved the Company’s Listing Application. Listing of the Company’s ordinary shares on the STAR Market is expected to be completed in 2021, subject to market conditions and additional regulatory approvals;
Signed an exclusive worldwide strategic collaboration with Shoreline Biosciences, Inc., to develop and commercialize a portfolio of NK-based cell therapeutics leveraging Shoreline’s iPSC NK cell technology and BeiGene’s research and clinical development capabilities for different malignancies; and
Expanded our Executive Committee with four new leaders:
Clare Fisher, Senior Vice President, Business Development and M&A;
Christiane Langer, M.D., Senior Vice President, Global Medical Affairs (ex-Greater China);
Bob Mecca, Senior Vice President, Finance; and
Adam Roach, Vice President, Head of APAC Commercial (ex-Greater China).
Second Quarter 2021 Financial Results

Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $4.4 billion as of June 30, 2021, compared to $4.8 billion as of March 31, 2021, and $4.7 billion as of December 31, 2020.

In the three months ended June 30, 2021, cash used in operating activities was $420.3 million, primarily due to our net loss of $480.3 million and a $42.9 million increase in our net operating assets and liabilities offset by non-cash charges of $102.9 million; capital expenditures were $38.5 million; cash used for a regulatory milestone was $7.5 million; and cash provided by financing activities was $35.6 million, consisting primarily of bank loan proceeds and the exercise of employee share options.
Revenue for the three months ended June 30, 2021 was $150.0 million, compared to $65.6 million in the same period of 2020.

Product revenues totaled $138.6 million for the three months ended June 30, 2021, compared to $65.6 million in the same period of 2020, and comprised:
Sales of tislelizumab in China of $74.9 million, compared to $29.4 million in the prior year period;
Sales of BRUKINSA of $42.4 million, compared to $7.0 million in the prior year period;
Sales of pamiparib, our third internally discovered and developed medicine to receive marketing authorization, of $2.2 million in China. We commenced sales and marketing in China in May 2021;
Sales of XGEVA, the first product transferred to BeiGene from the Amgen collaboration, in China of $3.3 million. BeiGene commenced sales and marketing in China in July 2020;
Sales of Bristol Myers Squibb (BMS) in-licensed products in China of $13.4 million, compared to $29.2 million in the prior year period; and
Collaboration revenue for the three months ended June 30, 2021 was $11.4 million, resulting from the partial recognition of previously deferred revenue associated with the upfront payment received from Novartis in the first quarter of 2021. There was no collaboration revenue for the prior year period.
Expenses for the three months ended June 30, 2021 were $624.8 million, compared to $424.5 million in the same period of 2020.

Cost of Sales for the three months ended June 30, 2021 were $36.3 million, compared to $14.3 million in the same period of 2020. Cost of sales increased primarily due to increased product sales of tislelizumab, BRUKINSA, and XGEVA, and were partially offset by lower sales of BMS in-licensed products.
R&D Expenses for the three months ended June 30, 2021 were $356.1 million, compared to $286.0 million in the same period of 2020. The increase in R&D expenses was primarily attributable to increases in headcount and external costs related to our investment in discovery and development activities, including our continued efforts to internalize research and clinical trial activities, as well as $45.0 million for an upfront fee related to in-process R&D. R&D expense increases were partially offset by decreased spending on clinical trials related to tislelizumab and BRUKINSA. Additionally, R&D-related share-based compensation expense was $30.2 million for the three months ended June 30, 2021, compared to $23.7 million for the same period of 2020.
SG&A Expenses for the three months ended June 30, 2021 were $232.3 million, compared to $124.0 million in the same period of 2020. The increase in SG&A expenses was primarily attributable to increased headcount and increased external expenses related to the growth of our global commercial organization, as we continue to build our worldwide footprint. SG&A-related share-based compensation expense was $34.6 million for the three months ended June 30, 2021, compared to $21.8 million for the same period of 2020.
Net Loss for the three months ended June 30, 2021 was $480.3 million, or $0.40 per share, and $5.23 per American Depositary Share (ADS), compared to $335.2 million, or $0.33 per share, and $4.31 per ADS in the same period of 2020.

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.