Kura Oncology to Report Second Quarter 2020 Financial Results

On July 30, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that it will report second quarter 2020 financial results after the close of U.S. financial markets on Thursday, August 6, 2020 (Press release, Kura Oncology, JUL 30, 2020, View Source [SID1234562581]). Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

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The live call may be accessed by dialing (866) 278-7953 for domestic callers and (323) 347-3281 for international callers and entering the conference code: 1697775. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

Intellia Therapeutics to Hold Conference Call to Discuss Second Quarter 2020 Earnings and Company Updates

On July 30, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, will present its second quarter 2020 financial results and operational highlights in a conference call on August 6, 2020 at 8 a.m. ET (Press release, Intellia Therapeutics, JUL 30, 2020, View Source [SID1234562580]).

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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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To join the call:

U.S. callers should dial 1-877-317-6789 and international callers should dial +1-412-317-6789, approximately five minutes before the call.
All participants should ask to be connected to the Intellia Therapeutics conference call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section of the company’s website at www.intelliatx.com, beginning on August 6, 2020 at 12 p.m. ET.

Chi-Med Reports 2020 Interim Results and Provides Updates on Key Clinical Programs

On July 30, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM), an innovation-driven, commercial-stage biopharmaceutical company, reported its unaudited financial results for the six months ended June 30, 2020 and provides updates on key clinical and commercial developments (Press release, Hutchison China MediTech, JUL 30, 2020, https://www.chi-med.com/interim-results-2020/ [SID1234562579]).

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"During the first half of 2020, we continued to build our fully integrated business in China, from research and development to manufacturing and commercialization and sales, with a focus on oncology," said Mr. Simon To, Chairman of Chi-Med. "NDAs for surufatinib and savolitinib are currently under review by the China NMPA6 and we are now preparing for multiple potential launches employing our newly-established commercial organization in oncology, covering all provinces in Mainland China."

"We are also one of a few China-based biotech companies working to realize the global potential of our home-grown innovative drug candidates," he added. "We currently have nine novel drug candidates in clinical trials, many with global potential, and an additional five drug candidates at the IND7-enabling stage."

"Over the past three years, we have significantly expanded our international development footprint and, in the first half of 2020, locked in global registration strategies for surufatinib and fruquintinib, while our global partnership with AstraZeneca8 is approaching the same for savolitinib. A deep pipeline of unpartnered earlier-stage oncology assets follows, with most notably, global development of our Syk9 and PI3Kδ10 assets progressing well and our IDH 1/211 inhibitor expected to start Phase I in the United States this year."

"We believe that the anticipated launches of multiple innovative oncology drugs over the next twelve to eighteen months will address a broad range of unmet medical needs and benefit a large number of patients globally, propelling Chi-Med into a new phase of growth."

FIRST HALF 2020 OPERATING HIGHLIGHTS

Set out below are some of Chi-Med’s operating highlights so far this year. For more details, please refer to "Operations Review" below.

I. PREPARING TO LAUNCH MULTIPLE ONCOLOGY DRUGS IN CHINA

Savolitinib – NDA submitted for potential first-in-class selective MET TKI12 in China:

NDA accepted by NMPA in MET Exon 14 skipping mutation NSCLC: presented positive results at ASCO (Free ASCO Whitepaper)13 from a registration study in MET Exon 14 skipping mutation NSCLC demonstrating 49.2% ORR14, 93.4% DCR15 and 9.6 months DoR16 in efficacy evaluable patients, underpinning the NDA acceptance in May 2020 and subsequent grant of Priority Review status in July 2020.
Surufatinib – Two NDAs with first China launch in NET planned for late 2020:

Progressed non-pancreatic NET NDA: Supported by the positive SANET-ep Phase III and submitted in late 2019, the NMPA NDA review process is on-track, and we continue to plan for launch in late 2020;
Submitted Pancreatic NET NDA: Following positive interim analysis and early termination of SANET-p Phase III, an NDA for pancreatic NET has been submitted in China, which we anticipate may be accepted in the near term;
Progressed to Phase II for Tuoyi combination: Initiated a Phase II in early 2020 in eight solid tumor indications for surufatinib plus Tuoyi, a China-approved PD-117 antibody from Junshi18. Data presented at AACR (Free AACR Whitepaper)19, shows the combination is well tolerated with encouraging activity, ORR 64% and DCR 100% in efficacy evaluable patients at the RP2D20; and
Initiated Tyvyt PD-1 combination: In July 2020, Innovent21 initiated a Phase I combining surufatinib with their China-approved PD-1 monoclonal antibody, Tyvyt.
Fruquintinib – Commercial progress on Elunate (fruquintinib capsules):

174% overall increase in Elunate prescriptions22 during the first half of 2020: Inclusion in the 2020 National Reimbursement Drug List ("NRDL") has led to a major increase in access. In-market sales, as provided by Lilly23, were $14.0 million24 (H1-19: $11.4m) during the first half of 2020;
Chi-Med to commercialize Elunate in China beginning in October 2020: In July 2020, an agreement was reached with Lilly that Chi-Med will commence medical detailing and marketing activities for Elunate across all of China effective October 1, 2020;
Phase III interim analysis in second-line gastric cancer: In June 2020, following the second and final interim analysis for futility of the FRUTIGA study in China the IDMC25 recommended to continue the study. FRUTIGA is expected to complete enrollment in late 2020 or early 2021; and
Expanded Tyvyt PD-1 combination: Phase I dose escalation for the fruquintinib and Tyvyt combination completed in July 2020. A Phase Ib expansion study at the RP2D is underway in China targeting five solid tumor indications.
Established in-house oncology commercial organization – Team now in place for imminent launches:

An in-house oncology commercial organization has now been established with over 320 staff, versus about 90 at the start of 2020, in order to support the potential launch of surufatinib in China and commercialization of Elunate.

II. REALIZING THE GLOBAL POTENTIAL OF OUR LATE STAGE ONCOLOGY ASSETS

Surufatinib – U.S. NDA under preparation:

Secured FDA Fast Track Designations: FDA granted Fast Track Designations for both pancreatic NET and non-pancreatic NET in April 2020;
Positive U.S. NET bridging study: Presented results at ASCO (Free ASCO Whitepaper) from the U.S. Phase Ib NET study in June 2020, reporting 100% DCR in heavily pre-treated pancreatic-NET and non-pancreatic NET patients;
Agreed U.S. NDA submission pathway: In May 2020, agreed with FDA that the two pivotal NET studies in China, along with existing data from the U.S. bridging study, could support an NDA submission. Now planning a U.S. NDA rolling submission from late 2020 into early 2021;
U.S. commercial launch strategy: Work underway to establish U.S. launch readiness for late 2021;
Progressed European regulatory discussions: Engaging extensively with European regulatory authorities, targeting MAA26 submission for NET during 2021; and
BeiGene27 global PD-1 collaboration: Entered into a clinical collaboration in May 2020 to explore the combination of surufatinib with BeiGene’s PD-1 antibody, tislelizumab, in the U.S..
Fruquintinib – global Phase III registration study in CRC28 underway:

Secured FDA Fast Track Designation: Granted in June 2020 for patients with metastatic CRC;
Initiated FRESCO-2 global Phase III registration study in CRC: Following study design endorsement by the FDA, EMA29 and PMDA30, we initiated the global Phase III registration study in metastatic CRC. Enrollment of over 500 patients in ~130 sites in 10 countries targeted to complete in late 2021; and
BeiGene and Innovent global PD-1 collaborations: Entered into a clinical collaboration with BeiGene in the U.S., Europe, China and Australia in May 2020 to explore the combination of fruquintinib and tislelizumab. Our work with Innovent has now established the RP2D for the fruquintinib and Tyvyt combination and a U.S. IND is planned for late 2020.
Savolitinib – AstraZeneca collaboration making progress in lung and kidney cancer:

SAVANNAH interim analysis – In late July 2020, AstraZeneca and Chi-Med conducted a first internal interim analysis for the SAVANNAH global Phase II study of the savolitinib plus Tagrisso combination in EGFR mutation positive TKI refractory NSCLC patients. Early interim efficacy and safety data is now under review. The enrollment of the SAVANNAH study continues apace in 13 countries;
Encouraging efficacy in MET-driven PRCC31: In June 2020, we presented data at ASCO (Free ASCO Whitepaper) for SAVOIR, a Phase III study of savolitinib versus sunitinib. Savolitinib demonstrated encouraging efficacy compared to sunitinib with a 27% versus 7% ORR, a trend toward benefit in PFS32 and an improvement in OS33 with tolerability advantages; and
Preliminary signal for savolitinib/Imfinzi (PD-L134) combination in all PRCC: In February 2020, we presented data from the CALYPSO Phase II study at ASCO (Free ASCO Whitepaper) GU35 showing the combination was tolerable and associated with durable efficacy, with a 12.3 month median OS.

III. INVESTING IN THE FUTURE – EARLY PIPELINE

Non-Hodgkin’s lymphoma ("NHL"): Advanced Phase Ib expansion of both of our NHL assets, HMPL-523 (Syk) and HMPL-689 (PI3Kδ) in China. We expect these studies to inform our China registration study decisions in 2020. In the U.S. and Europe, we continued to expand development of HMPL-523 and HMPL-689, with over twenty Phase I sites now enrolling;
HMPL-453 – selective FGFR36 1/2/3 inhibitor: We initiated a Phase II study in advanced malignant mesothelioma in China in March 2020, with a second Phase II, in Cholangiocarcinoma, in planning;
HMPL-306 – IDH 1/2 dual inhibitor: In late July 2020, we dosed our first patient in a Phase I study in China with our ninth in-house discovered asset, HMPL-306; and
Five additional novel drug candidates in oncology are currently progressing through IND-enabling studies and are anticipated to reach the clinic over the next twelve to eighteen months.

IV. UPDATE ON THE IMPACT OF COVID-19

Working to effectively manage COVID-19 challenges: The COVID-19 outbreak initially posed some challenges to our operations resulting from restrictions in travel. Our teams adapted quickly and have been able to minimize the effect across our businesses thus far. We will continue to closely monitor the evolving situation. At this stage, we are unable to assess the long-term effect of the outbreak, if any.

KEY EVENTS PLANNED FOR BALANCE 2020 & EARLY 2021

CHINA EVENTS: A FULLY INTEGRATED ONCOLOGY BUSINESS IN CHINA
Fruquintinib
· Elunate China commercialization – Chi-Med to assume medical detailing and marketing activities for Elunate in all China on October 1, 2020; and

· Enrollment completion of FRUTIGA Phase III – complete enrollment of China registration study in second-line gastric cancer.

Surufatinib
· Presentation of SANET-p Phase III data – pancreatic NET patients study at ESMO (Free ESMO Whitepaper)37 2020 conference;

· Acceptance of NDA in pancreatic NET – following recent NDA submission based on positive SANET-p Phase III interim analysis;

· Phase II/III interim analysis – for futility in second-line BTC38 in China; and

· Potential NDA approval and launch for non-pancreatic NET – first un-partnered oncology drug launch for Chi-Med in China.

Savolitinib · Potential NDA approval and launch for NSCLC – monotherapy in MET Exon 14 skipping mutation NSCLC. If approved, this will be the first approval worldwide and the first selective c-MET TKI approval in China. Material milestone triggering event.
Early-stage Assets
· HMPL-689 (PI3Kδ) Phase I/Ib NHL data – potential presentation of China data at major scientific conference;

· HMPL-689 (PI3Kδ) – Potential registration study start – in indolent NHL in China;

· HMPL-523 (Syk) – Potential registration study start – in indolent NHL in China; and

· HMPL-523 (Syk) – completion of dose escalation in ITP39.

GLOBAL EVENTS: REALIZING THE GLOBAL POTENTIAL OF OUR ONCOLOGY ASSETS
Fruquintinib
· Global Phase III study (FRESCO-2) – expansion of registration study in CRC in 10 countries including the U.S., Europe and Japan; and

· Presentation of U.S. Phase Ib data – preliminary data from study of third and later line CRC patients at ESMO (Free ESMO Whitepaper) 2020 conference.

Surufatinib · U.S. NDA submission for pancreatic- and non-pancreatic NET – U.S. NDA rolling submission beginning in late 2020 through early 2021.
Savolitinib
· Internal interim analyses on SAVANNAH – Complete the review of the first internal interim analysis and conduct further interim analysis to inform regulatory strategy;

· Potential endorsement of global Phase III in kidney cancer – savolitinib monotherapy in MET-driven PRCC;

· Potential endorsement of global Phase III in NSCLC – Tagrisso combination in EGFRm40 positive, MET positive, NSCLC. Material milestone triggering event;

· Potential endorsement of global registration study in NSCLC – savolitinib in MET Exon 14 skipping mutation NSCLC; and

· Enrollment completion of SAVANNAH – AstraZeneca to complete enrollment of Phase II study, with registration potential, of savolitinib/Tagrisso combination.

Early-stage Assets
· HMPL-523 (Syk) – Global Phase Ib expansion – in indolent NHL in the U.S. and Europe;
· HMPL-306 (IDH 1/2) – U.S. IND submission and initiation of Phase I; and

· HMPL-689 (PI3Kδ) – Global Phase Ib expansion – in indolent NHL in the U.S. and Europe.

FINANCIAL HIGHLIGHTS

The items below are selected financial data for the six months ended June 30, 2020. All dollars are expressed in U.S. dollar currency unless otherwise stated. For more details, please refer to "Financial Review", "Operations Review" and "Interim Unaudited Condensed Consolidated Financial Statements" below.

OVERALL GROUP:
Group revenue of $106.8 million (H1-19: $102.2m);
Net loss attributable to Chi‑Med of $49.7 million (H1-19: net loss of $45.4m);
Adjusted Group (non-GAAP) net cash flows excluding financing activities was -$32.5 million (H1-19: -$34.2m). Cash from our Commercial Platform, as well as cash received from our multi-national partners, continued to offset a substantial portion of our R&D41 expenses;
Recent financing activity strengthens cash position. We held cash, cash equivalents and short-term investments of $281.0 million as of June 30, 2020 (December 31, 2019: $217.2m). In early July 2020, we completed a private placement to General Atlantic42, raising an additional $100.0 million in gross proceeds, to further strengthen our cash position; and
Additional unutilized bank facilities of $119.3 million (December 31, 2019: $119.3m) and bank borrowings of $26.8 million (December 31, 2019: $26.8m).
INNOVATION PLATFORM (our R&D operations):
Consolidated revenue was $7.8 million (H1-19: $7.3m) mainly from service fee payments from AstraZeneca and Lilly; and
Net loss from our Innovation Platform attributable to Chi-Med of $73.6 million (H1-19: net loss of $67.1m) resulting from expansion in the development of our nine novel drug candidates, with five now in global development, and establishment of scaled international clinical and regulatory operations.
COMMERCIAL PLATFORM (our commercial operations):
Total consolidated sales up 4% (9% at CER43) to $99.0 million (H1-19: $94.9m) mainly due to continued progress on our Prescription Drugs subsidiary Hutchison Sinopharm44 as well as manufacturing revenues and royalties from Elunate;
Total consolidated net income from our Commercial Platform attributable to Chi-Med up 14% (19% at CER) to $35.5 million (H1-19: $31.0m), strong performance despite the limitations posed by COVID-19 underpinned by the growing profits of our Prescription Drugs operations in China; and
Guangzhou land compensation: In June 2020, our 50/50 joint venture, HBYS45, entered into an agreement with the Guangzhou government for the return of an unused piece of land in return for cash compensation of up to $95 million. HBYS will receive compensation in stages over a period of approximately one year. The first $24.1 million payment was received by HBYS in late June 2020 and the return will be recorded in Chi-Med’s statement of operations in H2 2020.

FINANCIAL GUIDANCE

During the first half of 2020, we performed in-line with published guidance, with dividends from our Commercial Platform offsetting a material portion of our R&D expenses as expected.

Over the balance of 2020, cash investments will rise in a number of areas including: several major global clinical and regulatory activities such as the global FRESCO-2 Phase III for fruquintinib and the submission of the U.S. NDA for surufatinib; the first phase of construction of our new large-scale oncology manufacturing facility in Shanghai; and expansion of our commercial activities in oncology in China, specifically our new commercial role on Elunate and preparation for the surufatinib launch.

We assume at this stage that the financial impact of the COVID-19 outbreak will not be material to the Group. Since we cannot predict how the situation will evolve, we will monitor and adjust if needed, as new material information emerges. We therefore provide unchanged Financial Guidance for 2020 below.

Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Innovation Platform segment operating loss, adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the "Use of Non-GAAP Financial Measures and Reconciliation" below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

Conference Call and Audio Webcast Presentation Scheduled Today at 1 p.m. BST / 8 a.m. EDT / 8 p.m. HKT – Investors may participate in the call as follows: +44 20 3194 0569 (U.K.) / +1 646 722 4977 (U.S.) / +852 3027 6500 (Hong Kong), or access a live audio webcast of the call via Chi-Med’s website at www.chi-med.com/investors/event-information/.

Compugen Reports Second Quarter 2020 Results

On July 30, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the second quarter ended June 30, 2020 (Press release, Compugen, JUL 30, 2020, View Source [SID1234562578]).

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"We have reached an exciting phase of development at Compugen, rapidly advancing the clinical evaluation of our DNAM axis hypothesis, suggesting that PVRIG and TIGIT are two parallel and complementary inhibitory pathways in the axis and that blocking both PVRIG and TIGIT may be required in certain tumor types in order to generate or enhance an anti-tumor immune response. Furthermore, these two pathways intersect with the PD-1 pathway and as such, the simultaneous blockade of the three pathways may synergistically enhance anti-tumor immune responses in patient populations where the three are dominant," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "When we first introduced this hypothesis a few years ago, of the three targets, only PD-1 was clinically validated. Remarkably, in the past few quarters, we have shown preliminary signs of clinical activity of PVRIG blockade and more recently clinical validation of TIGIT blockade was presented by others. We believe that this data further confirms our preclinical work and increases our confidence in our hypothesis and the clinical path we are pursuing."

Dr. Cohen-Dayag added, "We are pleased with the progress we are making in advancing the evaluation of our clinical candidates in monotherapy and combination regimens. We are currently enrolling patients in our COM701 Phase 1 monotherapy expansion study, which leverages a biomarker-informed strategy to focus on tumor types where, we believe, the PVRIG/PVRL2 pathway may play a role. In addition, we completed enrollment in the dual combination dose escalation study of COM701 with Opdivo and plan to provide updated data from this study in the first half of 2021, when we also expect to provide initial results from the COM701 Phase 1 monotherapy expansion study. Furthermore, we are on-track to begin our Phase 1/2 triple combination study testing COM701 with Bristol Myers Squibb’s Opdivo and their investigational TIGIT inhibitor, at the second half of this year, to directly test our DNAM axis hypothesis through the simultaneous blockade of the PVRIG, TIGIT and PD-1 pathways."

"We remain focused on executing our science-driven clinical strategy to, hopefully, broaden the therapeutic potential of checkpoint inhibitors for the benefit of patient populations non-responsive to cancer immunotherapy. As the only company with wholly-owned clinical programs targeting both PVRIG and TIGIT, we are uniquely differentiated in the crowded immuno-oncology space," Dr. Cohen-Dayag concluded.

Second Quarter 2020 and Recent Highlights

Announced FDA clearance of IND application for Phase 1/2 triple combination study of COM701 with Bristol Myers Squibb’s Opdivo (nivolumab) and TIGIT inhibitor.

Designed to evaluate the simultaneous blockade of three immune checkpoint pathways, PVRIG, TIGIT and PD-1.

Complementary to the Company’s clinical strategy, the study will accelerate clinical evaluation of Compugen’s DNAM axis hypothesis and biomarker-driven approach in advanced solid tumors to broaden the patient population responsive to cancer immunotherapy.

Initiation of triple combination study remains on-track to begin during 2H 2020.

Dosed the first patient in the monotherapy expansion cohort in the ongoing Phase 1 clinical trial of COM701.

Presented updated data from the dose escalation arms of the Phase 1 trial of COM701 in patients with advanced solid tumors at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I (highlights):

o
COM701 was well-tolerated through 20 mg/kg IV Q4 weeks as a monotherapy and 10 mg/kg IV Q4 weeks in combination with Opdivo (480 mg IV Q4 weeks) with no dose-limiting toxicities reported.

o
Encouraging disease control rates of 69% (11/16) for monotherapy and 75% (9/12) for the combination arm.

50% of patients (6/12) in the combination arm remain on study, some with continued responses observed beyond 200 days of treatment.

Durable responses of stable disease for over six months in six of 28 patients (21%) across treatment arms.

Two confirmed partial responses, one from the monotherapy arm (microsatellite stable primary peritoneal cancer) and one from the combination arm (microsatellite stable colorectal cancer); both patients remained on treatment at the presentation date.

Dosed the first patient in a Phase 1 dose escalation clinical trial of COM902, an immuno-oncology therapeutic antibody targeting TIGIT, in patients with advanced malignancies.


Granted EPO Patent No. 3295951, covering the composition of matter for COM701 and backup antibodies including any anti-PVRIG antibody having the binding fragments of COM701 or backup antibodies for the treatment of cancer.


Published a peer-reviewed paper in Cancer Immunology Research in collaboration with Bayer, demonstrating in vitro T cell activation and in vivo anti-tumor activity of BAY 1905254, a first-in-class immuno-oncology antibody targeting ILDR2. ILDR2 is a novel immune checkpoint discovered computationally by Compugen which is currently being evaluated by Bayer in a Phase 1 study as monotherapy and in combination with Keytruda.

Financial Results
Research and development expenses for the second quarter ended June 30, 2020 were $4.4 million, compared with $4.9 million in the comparable quarter in 2019. The decrease was primarily due to cost reduction measures announced by the Company in the first quarter of 2019, offset by an increase in expenses associated with our various Phase 1 clinical studies.

Net loss for the second quarter of 2020 was $6.2 million, or $0.08 per basic and diluted share, compared with a net loss of $6.0 million, or $0.10 per basic and diluted share, in the comparable quarter of 2019.

As of June 30, 2020, cash, cash related accounts and short-term and long-term bank deposits totaled approximately $136 million, compared with approximately $44 million as of December 31, 2019.

Conference Call and Webcast Information
The Company will hold a conference call today, July 30, 2020, at 8:30 AM ET to review its second quarter 2020 results. To access the conference call by telephone, please dial 1-888-407-2553 from the United States, or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

Agios Reports Business Highlights and Second Quarter 2020 Financial Results

On July 30, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported business highlights and financial results for the second quarter ended June 30, 2020 (Press release, Agios Pharmaceuticals, JUL 30, 2020, View Source [SID1234562577]).

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"The second quarter was a productive and important time at Agios, as we accomplished several key 2020 objectives across our three focus areas of malignant hematology, solid tumors and rare genetic diseases. In particular, we made significant progress on our mitapivat clinical programs, including achieving proof-of-concept in sickle cell disease and planning for our pivotal development programs in both thalassemia and sickle cell disease," said Jackie Fouse, Ph.D., chief executive officer at Agios. "For the remainder of 2020, we are focused on the completion of our pivotal trials ACTIVATE and ACTIVATE-T for mitapivat in pyruvate kinase deficiency and securing regulatory feedback on the pivotal programs in both thalassemia and sickle cell disease to enable their initiation next year, the submission of a supplemental new drug application for TIBSOVO in cholangiocarcinoma in the first quarter of 2021, driving enrollment in our ongoing clinical trials and continued strong commercial execution."

SECOND QUARTER 2020 HIGHLIGHTS

Rare Genetic Diseases

Established clinical proof-of-concept for mitapivat in sickle cell disease based on a preliminary analysis of data on eight patients from the Phase 1 study being conducted in collaboration with the National Institutes of Health (NIH). Seven of eight (88%) evaluable patients experienced a hemoglobin increase, with five of eight patients (63%) achieving a hemoglobin increase of ≥1.0 g/dL from baseline. Additionally, the data showed improvements in associated markers of sickling as well as a safety profile consistent with previously reported mitapivat data or expected in the context of sickle cell disease.
Presented data on 13 patients from the Phase 2 study of mitapivat in non-transfusion-dependent α- and β-thalassemia at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in June. Treatment with mitapivat induced a hemoglobin increase of ≥1.0 g/dL in 12 of 13 (92%) evaluable patients, including four of four (100%) α-thalassemia patients. Additionally, the data showed improvements in associated markers of hemolysis and erythropoiesis as well as a safety profile consistent with previously reported mitapivat data.
Received Orphan Drug Designation from the Food and Drug Administration (FDA) for mitapivat in thalassemia.
Hematologic Malignancies and Solid Tumors

TIBSOVO net sales of $27.6 million, an increase of 22% from the first quarter of 2020; expanded total number of unique prescribers by 15% from the first quarter of 2020.
Published data from the Phase 3 ClarIDHy study of TIBSOVO in The Lancet Oncology. As a result of this publication, the National Comprehensive Cancer Network (NCCN) guidelines were updated to recommend treatment with TIBSOVO for patients with advanced IDH1-mutant cholangiocarcinoma.
Presented updated data from the Phase 1 dose-escalation study of vorasidenib in IDH-mutant non-enhancing glioma at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May. In the study, vorasidenib demonstrated prolonged disease control and encouraging preliminary activity, as well as a favorable safety profile consistent with previously reported data.
Corporate

Completed a $255 million purchase agreement with Royalty Pharma for IDHIFA (enasidenib) royalty rights and outstanding regulatory milestone payments.
KEY UPCOMING MILESTONES

Rare Genetic Diseases

Report data from ACTIVATE and ACTIVATE-T, the company’s two global pivotal trials for mitapivat in adults with pyruvate kinase (PK) deficiency, between the end of 2020 and mid-2021.
Finalize robust pivotal development plan for mitapivat in thalassemia, including both α-and β-thalassemia, as well as transfusion dependent and non-transfusion dependent patient populations, by the end of 2020.
Initiate first-in-human study in healthy volunteers for AG-946, a next-generation PKR activator, in Q3 2020.
Hematologic Malignancies and Solid Tumors

Deliver full-year 2020 U.S. revenue for TIBSOVO of $105-115 million.
Receive European Medicines Agency CHMP opinion for TIBSOVO in relapsed or refractory acute myeloid leukemia (AML) with an IDH1 mutation by the end of 2020.
Report mature overall survival data from ClarIDHy Phase 3 study in Q3 2020; if data are supportive, file supplemental new drug application (sNDA) for TIBSOVO in previously treated IDH1-mutant cholangiocarcinoma in Q1 2021.
Research

Achieve at least one new development candidate by year-end 2020.
SECOND QUARTER 2020 FINANCIAL RESULTS

Revenue: Total revenue for the second quarter of 2020 was $37.3 million, which includes $27.6 million of net product revenue from sales of TIBSOVO, $6.4 million in collaboration revenue and $3.3 million in royalty revenue from net global sales of IDHIFA under our collaboration agreement with Celgene, now a wholly owned subsidiary of Bristol Myers Squibb. This compares to revenue of $26.2 million for the second quarter of 2019. TIBSOVO net product revenue increased 101% from the same period last year.

Cost of Sales: Cost of sales were $0.7 million for the second quarter of 2020 compared to $0.3 million for the second quarter of 2019.

Research and Development (R&D) Expenses: R&D expenses were $90.9 million for the second quarter of 2020 compared to $107.4 million for the second quarter of 2019. The decrease in R&D expense was primarily attributable to milestone payments related to AG-636 and an undisclosed early-stage research program in the second quarter of 2019, winding down the ClarIDHy Phase 3 study of TIBSOVO and HOVON startup expenses incurred in the second quarter of 2019, and lower spend across ongoing TIBSOVO clinical studies as a result of slowed enrollment and reduced activities due to the COVID-19 pandemic.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $36.0 million for the second quarter of 2020 compared to $32.4 million for the second quarter of 2019. The increase in SG&A expense was primarily attributable to the initial gated infrastructure build of the company’s European operations offset by reduced travel and industry engagement given restrictions in place to combat the COVID-19 pandemic.

Net Loss: Net loss was $90.5 million for the second quarter of 2020 compared to $109.9 million for the second quarter of 2019.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of June 30, 2020 were $794 million, including the amount received under the Royalty Pharma agreement, compared to $624 million as of June 30, 2019. The company expects that its cash, cash equivalents and marketable securities as of June 30, 2020, together with anticipated product revenue, anticipated interest income and anticipated expense reimbursements under our collaboration and license agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements, including its pivotal development programs for mitapivat in thalassemia and sickle cell disease, through the end of 2022.

CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss its second quarter 2020 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 2955575. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

About the Agios/Celgene Collaboration
In 2010, Agios and Celgene Corporation, now a wholly owned subsidiary of Bristol Myers Squibb, entered into a collaboration agreement focused on cancer metabolism. Under the terms of the agreement, Celgene has worldwide development and commercialization rights for IDHIFA (enasidenib). Celgene and Agios are currently co-commercializing IDHIFA in the U.S., and Agios continues to conduct certain clinical development activities within the IDHIFA development program. Agios is eligible to receive a $25 million payment upon achievement of a specified ex-U.S. commercial milestone event, as well as reimbursement for costs incurred for its co-commercialization efforts and development activities.