On August 8, 2019 Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development, and ultimately the commercialization, of therapeutic drug candidates for both oncology and rare disease indications, reported its operational and financial results for the second quarter ended June 30, 2019 (Press release, Idera Pharmaceuticals, AUG 8, 2019, View Source [SID1234538420]).

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"Our team has demonstrated remarkable focus on execution during the first half of this year. We have made significant progress developing tilsotolimod and advancing it forward for patients facing the challenges of late-stage, anti-PD-1 refractory metastatic melanoma," stated Vincent Milano, Idera’s Chief Executive Officer. "Our accrual rate in the registrational ILLUMINATE-301 trial has exceeded our expectations, which is reflective of the high unmet need in this patient population."

Milano continued, "Additionally, we are providing data from the ILLUMINATE-204 trial, which we believe is informative as to the probability of success in the registrational trial. We also are advancing toward initiation of our first combination therapy trial in areas beyond melanoma, ILLUMINATE-206, which we expect will provide additional opportunities and milestones for data updates next year."

ILLUMINATE (tilsotolimod) Clinical Development

ILLUMINATE 301 — Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory metastatic melanoma:

· Overall Response Rate (ORR) and Overall Survival (OS) as family of primary endpoints;

· Trial initiated in the first quarter of 2018;

· Sites active in 11 countries: Approximately 100 sites participating.

Based on feedback from the ILLUMINATE-301 steering committee and global melanoma and immunology experts, we have elected to make the following modifications to the ILLUMINATE 301 trial design:

· Median OS improvement over ipilimumab alone of greater than or equal to 4.6 months from prior delta of improvement of 6.6 months;

· ORR improvement of 10 percentage points over ipilimumab alone from prior delta of improvement of 20 percentage points;

· Target effect size/hazard ratio adjusted to 0.71 from 0.63; resulting in a planned enrollment of approximately 450 patients from 308, of which 294 are currently enrolled; and

·Targeting completion of enrollment during the first half of 2020.

We along with our collaboration partner, BMS, have amended the prior Clinical Trial Collaboration and Supply Agreement to accommodate the increase in supply of ipilimumab for the ILLUMINATE-301 trial.

Additionally, we have solicited feedback from the U.S. Food and Drug Administration and they do not object to these changes. We also have solicited feedback from other global health authorities related to these changes.

ILLUMINATE 204 — Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:

· Completed enrollment with 52 patients at tilsotolimod 8 mg with ipilimumab in February 2019;

· Data as of August 5, 2019 on endpoints:

·27% ORR (n=13) of the 49 patients evaluable for efficacy; 74% (36) achieving disease control (best response of CR, PR or Stable Disease (SD));

· Durable responses (>6 mos.) observed in 8 of 13 responders;

· Median OS has not yet been reached (min/max: 1.6 mos. — 35 mos.);

· The safety profile observed in this analysis was consistent with previously reported results, with no emergence of new safety signals;

· 43% (n=21) of patients enrolled into trial presented at baseline with Eastern Cooperative Oncology Group (ECOG) performance status 2; and

· Final results from the ILLUMINATE 204 trial are expected to be submitted for an abstract at a medical conference during the first half of 2020.

ILLUMINATE 206 — Phase 2, multi-center trial to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab in treating patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Microsatellite Stable Colorectal Cancer (MSS-CRC).

· On March 11, 2019, we entered into a second clinical trial collaboration with BMS in which BMS has agreed to manufacture and supply YERVOY (ipilimumab) and OPDIVO (nivolumab) for no charge for use in ILLUMINATE-206;

· Trial expected to initiate in the third quarter of 2019 beginning with the MSS-CRC cohort.

ILLUMINATE 101 — Phase 1b trial of tilsotolimod monotherapy in patients with refractory solid tumors:

· Completed enrollment in all dose cohorts of the trial;

· Initial data presented at American Academy for Cancer Research (AACR) (Free AACR Whitepaper) 2019 conference;

·Of 29 evaluable patients, 13 (45%) had a RECIST v1.1 disease assessment of stable disease (SD), with a disease control rate of 45%;

·One patient with uterine leiomyosarcoma has been on tilsotolimod treatment for more than a year with durable stable disease and is continuing under a treatment investigational new drug;

· One patient in the melanoma cohort achieved an unconfirmed RECIST v.1.1 partial response (PR) with 35% tumor shrinkage in the target lesion; and

· Abstract submission accepted for poster presentation at the European Society for Medical Oncology 2019 Conference being held in Barcelona, Spain in September 2019.

Corporate Updates:

·Elizabeth A. Tarka, MD, FACC was appointed as Chief Medical Officer effective July 22, 2019; and

· John J. Kirby was appointed as Chief Financial Officer effective July 22, 2019.

Upcoming Investor Presentation:

· The company will be presenting at the 2019 Wedbush PacGrow Healthcare Conference on Tuesday, August 13, 2019 at 1:20 PM ET. The conference is being held at the Parker New York Hotel. The webcast can be accessed live or in archived form in the "Investors" section of the company’s website at www.iderapharma.com.

Financial Results

Second Quarter Results

Net loss applicable to common stockholders for the three months ended June 30, 2019 was $11.2 million, or $0.39 per basic and diluted share, compared to net loss applicable to common stockholders of $16.0 million, or $0.59 per basic and diluted share, for the same period in 2018. Revenue for the three months ended June 30, 2019 was $1.4 million, compared to $0.2 million for the same period in 2018. Research and development expenses for the three months ended June 30, 2019 totaled $10.0 million compared to $10.9 million for the same period in 2018. General and administrative expense for the three months ended June 30, 2019 totaled $2.9 million compared to $4.0 million for the same period in 2018. Merger-related costs, net for the three months ended June 30, 2018 totaled $1.6 million and related to our contemplated merger transaction. No such costs were incurred for the same period in 2019. Restructuring costs for the three months ended June 30, 2019 were nominal and related to our decision in July 2018 to wind-down our discovery operations. No such costs were incurred for the same period in 2018.

As of June 30, 2019, our cash, cash equivalents and short-term investments totaled $52.4 million compared to $71.4 million as of December 31, 2018. We currently anticipate that, based on our current operating plan, our existing cash, cash equivalents and investments will fund our operations into the second quarter of 2020.

Investor Event and Webcast

Idera will host a conference call and live webcast today, Thursday, August 8, 2019, at 10:00 A.M. EST to provide an overview of today’s update along with a question and answer session. To participate in the conference call, please dial (844) 882-7837 (domestic) and (574) 990-9824 (international). The webcast can be accessed live or in archived form in the "Investors" section of the company’s website at www.iderapharma.com.

On August 8, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported its financial results for the three- and six-months ended June 30, 2019 (Press release, Eagle Pharmaceuticals, AUG 8, 2019, View Source [SID1234538419]). Highlights of, and subsequent to, the second quarter of 2019 include:

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Business and Financial Highlights:

On August 5, 2019, Eagle announced a clinical development plan, following guidance from the U.S. Food and Drug Administration (FDA), for its fulvestrant formulation, intended to deliver maximum estrogen receptor inhibition in patients with estrogen receptor (ER)-positive breast cancer:
Eagle plans to initiate a pilot study shortly
Once the pilot study results are reviewed, a clinical pivotal trial based upon the parameters determined with FDA will be conducted in a target patient population
The pivotal trial is expected to be completed within approximately 12 months of commencing enrollment
The Company’s mid- and late-stage pipeline programs are on track;
Total revenue for the second quarter of 2019 was $56.7 million, compared to $59.3 million in the second quarter of 2018;
Q2 2019 BELRAPZO product sales were $15.4 million, compared to $8.1 million in Q2 2018;
Q2 2019 RYANODEX product sales were $2.9 million, compared to $7.2 million in Q2 2018;
Q2 2019 net income was $6.7 million, or $0.49 per basic and $0.48 per diluted share, compared to net income of $2.7 million, or $0.18 per basic and $0.17 per diluted share in Q2 2018;
Q2 2019 adjusted non-GAAP net income was $11.8 million, or $0.86 per basic and $0.84 per diluted share, compared to adjusted non-GAAP net income of $14.7 million, or $0.99 per basic and $0.95 per diluted share in Q2 2018;
During Q2 2019, Eagle purchased an additional $15.0 million of Eagle common stock as part of its share buyback program; since August 2016, Eagle has repurchased $168.9 million of Eagle common stock; and
Cash and cash equivalents were $108.1 million, net accounts receivable was $60.3 million, and debt was $41.3 million as of June 30, 2019.
"We had another strong quarter; earnings from our bendamustine portfolio have established a solid platform from which to advance our R&D programs and explore additional opportunities to add to our portfolio. Our fulvestrant program looks very promising and we believe our novel formulation has a unique profile that may lead to improved efficacy outcomes for breast cancer patients. With guidance from FDA, we plan to conduct a pilot study shortly followed by a pivotal trial to test our hypothesis," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"Moreover, we continue to advance the other assets in our portfolio. We are in discussions with the U.S. military regarding treatment of radiation syndrome, and we also plan to request a meeting with FDA shortly to discuss the regulatory path for our nerve agent indication. We continue to advance EA-111, our intramuscular version of dantrolene," added Tarriff.

"With these initiatives underway, and our pemfexy and vasopressin litigations proceeding as anticipated, we believe we are closer than ever before to unlocking the significant value of the multiple assets in our pipeline. We intend to continue to invest in our research and development programs and align our resources to support the successful launch of our assets, once approved," concluded Tarriff.

Second Quarter 2019 Financial Results

Total revenue for the three months ended June 30, 2019 was $56.7 million, as compared to $59.3 million for the three months ended June 30, 2018.

Royalty revenue was $27.3 million in the second quarter of 2019, compared to $36.3 million in the second quarter of 2018. BENDEKA royalties were $26.5 million in the second quarter of 2019, compared to $34.7 million in the second quarter of 2018. A summary of total revenue is outlined below:

Gross Margin was 62% during the second quarter of 2019, as compared to 69% in the second quarter of 2018. The compression in gross margin in the second quarter of 2019 was primarily driven by an increase in BENDEKA product sales to our marketing partner, on which Eagle earns no profit.

R&D expense was $9.0 million for the quarter, compared to $15.3 million in the same quarter in the prior year. The second quarter year over year decrease reflects a substantial reduction in fulvestrant expense, partially offset by the cost to bring vasopressin to market. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the second quarter was $7.8 million.

SG&A expense in the second quarter of 2019 increased to $17.2 million compared to $16.0 million in the second quarter of 2018. External legal spend associated with litigation on PEMFEXY, vasopressin and bendamustine and higher stock compensation expense account for the year over year increase. Excluding stock-based compensation and other non-cash and non-recurring items, second quarter 2019 SG&A expense was $12.4 million.

Net income for the second quarter of 2019 was $6.7 million, or $0.49 per basic and $0.48 per diluted share, compared to net income of $2.7 million, or $0.18 per basic and $0.17 per diluted share in the second quarter of 2018, due to the factors discussed above.

Adjusted non-GAAP net income for the second quarter of 2019 was $11.8 million, or $0.86 per basic and $0.84 per diluted share, compared to Adjusted non-GAAP net income of $14.7 million or $0.99 per basic and $0.95 per diluted share in the second quarter of 2018. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

2019 Expense Guidance

R&D spend in 2019, on a non-GAAP basis, is expected to be $32.0-$36.0 million, as compared to $38.0 million in 2018.
SG&A spend in 2019, on a non-GAAP basis, is expected to be $51.0-$54.0 million, as compared to $43.0 million in 2018.
The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of June 30, 2019, the Company had $108.1 million in cash and cash equivalents and $60.3 million in net accounts receivable, $37.6 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $41.3 million in outstanding debt. Therefore, at June 30, 2019, the Company had net cash and receivables of $127.2 million.

In the second quarter of 2019, we purchased $15.0 million of Eagle’s common stock as part of our share buyback program. Since August 2016, we have repurchased $168.9 million of our common stock.

Conference Call

As previously announced, Eagle management will host its second quarter 2019 conference call as follows:

Date

Thursday, August 8, 2019

Time

8:30 A.M. EDT

Toll free (U.S.)

877-876-9173

International 785-424-1667
Webcast (live and replay) www.eagleus.com, under the "Investor + News" section
A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-5685 (US) or 402-220-2567 (International) and entering conference call ID EGRXQ219. The webcast will be archived for 30 days at the aforementioned URL.

On August 8, 2019 Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the second quarter of 2019 (Press release, Cytokinetics, AUG 8, 2019, View Source [SID1234538418]). Net loss for the second quarter was $32.1 million, or $0.56 per share, compared to net loss for the second quarter of 2018 of $27.5 million, or $0.51 per share. Cash, cash equivalents and investments totaled $175.1 million at June 30, 2019.

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"During the second quarter, we made progress across the breadth of our pipeline, with particular emphasis on our investigational medicines for cardiovascular diseases of muscle dysfunction," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Our recently completing enrollment in GALACTIC-HF represents a significant milestone towards potentially bringing forward a novel therapy to address the high mortality and hospitalization rates in patients with heart failure. Additionally, we are pleased with encouraging data arising from the Phase 1 study of CK-274 and look forward to the planned initiation of a Phase 2 trial in patients with obstructive hypertrophic cardiomyopathy later this year. Our leadership in muscle biology affords us multiple opportunities to advance our drug candidates as our clinical trials generate clinical evidence to support the promise of potential new therapies."

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Continued conduct of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. In July 2019 we announced the completion of patient enrollment in GALACTIC-HF, having enrolled over 8,200 patients in 35 countries. We expect GALACTIC-HF to continue throughout 2019 and the next planned interim analysis in the first half of 2020.

Continued conduct of METEORIC-HF, (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. METEORIC-HF is a randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. We expect to continue enrollment of METEORIC-HF throughout 2019.
AMG 594 (cardiac troponin activator)

Continued conduct of the Phase 1 study of AMG 594 to assess its safety, tolerability, pharmacokinetics and potential to increase cardiac function in healthy volunteers. AMG 594 is a novel, selective, oral, small molecule cardiac troponin activator, discovered under a joint research program with Amgen. This Phase 1 study is being conducted by Amgen in collaboration with Cytokinetics. We expect the conduct of this study to continue throughout 2019.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Continued conduct of the Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-274 in healthy adult subjects. CK-274 is a wholly-owned, novel cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy (HCM). Results from the Phase 1 study have been accepted for presentation at the 23rd Annual Heart Failure Society of America (HFSA) Scientific Meeting in Philadelphia in September 2019.

Received feedback from FDA regarding the design of a planned Phase 2 clinical trial of CK-274 and made preparations for the start of that trial which we expect to begin in the fourth quarter of this year.

Presented preclinical data at the American Heart Association’s Basic Cardiovascular Sciences (BCVS) Scientific Sessions in Boston demonstrating that CK-274 produces exposure related effects on cardiac contractility in healthy animals and mouse models of HCM and support the therapeutic hypothesis relating to onset of action and reversibility.
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Presented results from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS) at the American Academy of Neurology 71st Annual Meeting in Philadelphia. FORTITUDE-ALS did not achieve statistical significance for a pre-specified dose-response relationship in its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing (p=0.11). Patients on all dose groups of reldesemtiv declined less than patients on placebo for SVC and ALSFRS-R, with larger and clinically meaningful differences emerging over time. While the dose-response analyses for the primary and secondary endpoints did not achieve statistical significance at the level of 0.05, in a post-hoc analysis pooling the doses together, the ALSFRS-R total score in patients who received reldesemtiv declined less than patients who received placebo (p = 0.01). The trial showed effects favoring reldesemtiv across dose levels and timepoints with clinically meaningful magnitudes of effect observed at 12 weeks for the primary and secondary endpoints.

Continued to analyze results from FORTITUDE-ALS to inform the design of a potential Phase 3 trial and registration program that may begin in 2020.

Concluded a Phase 1 study of reldesemtiv in healthy volunteers designed to assess higher doses and related plasma exposures than were evaluated in the prior Phase 2 study of patients with SMA. We are evaluating the data from the study to inform the design of potential future clinical trials.

Presented data from two preclinical studies of reldesemtiv at the 2019 Annual Cure SMA Conference in Anaheim, CA, showing that the addition of reldesemtiv to treatment with SMN upregulators (nusinersen and SMN-C1, an analogue to risdiplam) significantly increased muscle force in a mouse model of spinal muscular atrophy (SMA).
Pre-Clinical Development and Ongoing Research

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation fast skeletal muscle troponin activator (FSTA), under our collaboration with Astellas.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators; Astellas is sponsoring Cytokinetics’ research activities through 2019.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

We are currently in discussions with Astellas regarding amending the terms of our collaboration agreement, including, for reldesemtiv, the level of potential funding and share of commercial returns, as well as which company would be responsible for development and commercialization.

Announced the continuation of our partnership with The ALS Association in the fight against ALS with renewal of Gold Level Sponsorship of the National Walks to Defeat ALS and Premier Level National ALS Advocacy Conference Sponsorship as well as Platinum Level Sponsorship for initiatives led by The ALS Association Golden West Chapter, including grant funding for care services for people living with ALS in the San Francisco Bay Area.
Financials

Revenues for the three and six months ended June 30, 2019 were $7.1 million and $15.6 million, respectively, compared to $6.2 million and $11.5 million for the corresponding periods in 2018. The increase in revenues for the three and six month ended June 30, 2019 was due primarily to reimbursements for METEORIC-HF offset by no license revenue in 2019. License revenues in the second quarter and first half of 2018 were related to the Phase 2 study of reldesemtiv in spinal muscular atrophy completed in 2018.

Research and development expenses for the three and six months ended June 30, 2019 increased to $24.0 million and $47.6 million, respectively compared to $21.6 million and $43.7 million for the same periods in 2018, respectively due to increased spending related to METEORIC-HF and the development of CK-274, offset in part by reduced spending for reldesemtiv as well as for tirasemtiv, following suspension of development of tirasemtiv in late 2017.

General and administrative expenses for the three and six months ended June 30, 2019 increased to $9.8 million and $19.3 million from $8.0 million and $17.3 million in 2018 due primarily to an increase in outside legal counsel and personnel related costs.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s second quarter 2019 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 1778276.

An archived replay of the webcast will be available via Cytokinetics’ website until August 15, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 1778276 from August 8, 2019 at 7:30 PM Eastern Time until August 15, 2019.

On August 8, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the second quarter ended June 30, 2019 (Press release, Checkpoint Therapeutics, AUG 8, 2019, http://checkpointtx.com/press-releases/checkpoint-therapeutics-reports-second-quarter-2019-financial-results-and-recent-corporate-highlights/ [SID1234538417]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "During the second quarter, we continued to advance our lead clinical programs toward key interim data readouts expected in the second half of 2019. We look forward to reporting additional clinical data for CK-101, our novel, oral, third-generation epidermal growth factor receptor ("EGFR") inhibitor, before year-end, with the goal of commencing a Phase 3 clinical trial in first-line EGFR mutation-positive non-small cell lung cancer ("NSCLC") in 2020. In May, we announced positive interim clinical results for cosibelimab (formerly CK-301), our fully human anti-PD-L1 antibody, showing anti-tumor activity across multiple advanced cancers. The initial data are encouraging and potentially differentiate cosibelimab from other drugs in this class as a result of its dual mechanism of action through engaging both T-cells and NK cells. We intend to announce updated clinical data on cosibelimab later this year."

Financial Results:

Cash Position: As of June 30, 2019, Checkpoint’s cash and cash equivalents totaled $13.2 million. On a non-GAAP basis, pro-forma cash and cash equivalents as of June 30, 2019 (excluding third quarter 2019 operations) totaled approximately $16.2 million, after giving effect to approximately $3.0 million of net proceeds from the utilization of the Company’s At-the-Market Issuance Sales Agreement (the "ATM") during the third quarter of 2019. Checkpoint believes that its cash and cash equivalents and projected licensing revenue, along with the additional capital raised in the third quarter of 2019, will be sufficient to fund its anticipated operating cash requirements for at least 12 months.
R&D Expenses: Research and development expenses for the second quarter of 2019 were $4.1 million, compared to $5.5 million for the second quarter of 2018, a decrease of $1.4 million. Research and development expenses for the second quarter of 2019 included $0.2 million of non-cash stock expenses, compared to a credit of $0.4 million in stock compensation expense for the second quarter of 2018. The Company expects that, for the balance of 2019, research and development expenses will continue to remain lower than the comparable periods in 2018.
G&A Expenses: General and administrative expenses for the second quarter of 2019 were $1.8 million, compared to $1.4 million for the second quarter of 2018, an increase of $0.4 million. General and administrative expenses for the second quarter of 2019 included $0.7 million of non-cash stock expenses, compared to $0.5 million for the second quarter of 2018.
Net Loss: Net loss attributable to common stockholders for the second quarter of 2019 was $4.8 million, or $0.15 per share, compared to a net loss of $6.6 million, or $0.23 per share, for the second quarter of 2018. The net loss for the second quarter of 2019 included $0.9 million of non-cash stock expenses, compared to $0.1 million for the second quarter of 2018.
Recent Corporate Highlights:

In May 2019, Checkpoint announced positive interim safety and efficacy data from its ongoing multicenter Phase 1 clinical trial of cosibelimab. Cosibelimab is a high affinity, fully-human IgG1 monoclonal antibody that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab is potentially differentiated from currently marketed PD-1 and PD-L1 antibodies with a half-life that supports sustained >99% tumor target occupancy and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potentially enhanced efficacy in certain tumor types. Cosibelimab appeared to be safe and well-tolerated with no dose-limiting toxicities. Objective responses and target lesion reductions were observed across diverse tumor types, particularly in NSCLC and cutaneous squamous cell carcinoma.
In July 2019, Checkpoint announced that it was added to the Russell 2000 Index.

On August 8, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a 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, 2019. As of June 30, 2019, cash equivalents and investments totaled $153.2 million (Press release, Calithera Biosciences, AUG 8, 2019, View Source [SID1234538415]).

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"In the second quarter, we achieved clinical proof of concept for our glutaminase inhibitor telaglenastat, with positive topline results of the randomized phase 2 ENTRATA study," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "After completing a secondary offering in the quarter, we are well positioned to execute on our strategy and advance our pipeline forward. In the second half of the year, we look forward to completing enrollment in our registrational CANTATA trial evaluating telaglenastat for the treatment of patients with renal cell carcinoma, as well as presenting data from our arginase inhibitor program INCB001158."

Second Quarter 2019 and Recent Highlights

Achieved positive topline results in randomized Phase 2 ENTRATA study of telaglenastat (CB-839) with everolimus in renal cell carcinoma. The ENTRATA trial (NCT03163667) was a Phase 2 randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including at least one prior VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA was progression-free survival (PFS). The combination doubled the median PFS in heavily pretreated patients with advanced RCC. Telaglenastat, when added to everolimus, doubled the median PFS to 3.8 months as compared to 1.9 months for everolimus alone and reduced the risk of disease progression or death by 36% (HR=0.64, p=0.079 one-sided). The primary endpoint of the trial was PFS per investigator assessment with a predetermined threshold of p£0.2 one-sided. The secondary endpoint of overall survival is not yet mature.

Initiated Phase 1/2 clinical trial of telaglenastat in combination with palbociclib for solid tumors. The Phase 1/2 clinical trial is evaluating telaglenastat in combination with Pfizer’s CDK4/6 inhibitor palbociclib, also known as Ibrance. The study will evaluate the safety and anti-tumor activity of telaglenastat plus palbociclib in patients with KRAS-mutated colorectal cancer (CRC) and KRAS-mutated non-small cell lung cancer (NSCLC).

Advanced INCB001158 arginase inhibitor immuno-oncology program. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with cancer both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Data from INCB001158 are expected to be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September.

Presented new preclinical data for CB-708 at AACR (Free AACR Whitepaper) Annual Meeting. CB-708 is a selective, oral inhibitor of CD73, an enzyme that synthesizes the immunosuppressive agent adenosine and is over expressed in multiple tumor types. By blocking adenosine production in the tumor, CB-708 is designed to enhance T-cell activation leading to anti-tumor activity. Calithera anticipates that CB-708 will enter clinical trials in the second half of 2019.

Completed public offering of common stock. In June 2019, Calithera completed an underwritten public offering of common stock. Gross proceeds from the offering, before underwriting discounts and commissions and offering expenses, were $57.5 million.

Selected Second Quarter 2019 Financial Results

Cash, cash equivalents and investments totaled $153.2 million at June 30, 2019.

Research and development expenses were $20.9 million for the three months ended June 30, 2019, compared with $17.3 million for the same period in the prior year. The increase of $3.6 million was primarily due to a $1.5 million increase in the telaglenastat program, including for the CANTATA trial, an increase of $1.5 million in the INCB001158 program, and an increase of $0.7 million in the CB-280 program, partially offset by a decrease of $0.1 million for investment in our early stage research programs.

General and administrative expenses were $4.0 million for the three months ended June 30, 2019, compared with $3.5 million for the same period in the prior year. The increase of $0.5 million was related to higher professional services costs.

Net loss for the three months ended June 30, 2019 was $24.2 million, or $0.58 per share.

Conference Call Information

Calithera will host an update conference call today, Thursday, August 8 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 and referring to conference ID 9239839. 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.