On August 8, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported its second quarter and first half financial results for 2019 (Press release, Intrexon, AUG 8, 2019, View Source [SID1234538421]).

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Recent Business Highlights:

Precigen, Inc., a wholly owned subsidiary of Intrexon, announced the first patient dosed with PRGN-3005, an investigational autologous chimeric antigen receptor T (CAR-T) cell therapy developed using Precigen’s non-viral UltraCAR-T platform. PRGN-3005 UltraCAR-T therapy is under investigation for the treatment of patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer (clinical trial identifier: NCT03907527);

Precigen, Inc., announced the first patient dosed with PRGN-3006, an investigational autologous CAR-T cell therapy developed using Precigen’s non-viral UltraCAR-T platform for the treatment of patients with relapsed or refractory acute myeloid leukemia or higher risk myelodysplastic syndrome (clinical trial identifier: NCT03927261);

Intrexon entered into an agreement under which it will contribute its Methane Bioconversion Platform, together with all its associated technologies and facilities, to MBP, LLC, a newly formed company that will be headed by David Dewhurst, who is purchasing equity capital in the venture;

Oxitec, Ltd., a wholly owned subsidiary of Intrexon, successfully completed the first pilot project of its 2nd Generation Friendly Aedes aegypti technology in Brazil, a mosquito strain that unlocks new performance features, greater cost-effectiveness and scalability over Oxitec’s 1st generation with limited production requirements. Oxitec’s new mosquitoes achieved excellent results in urban, dengue-prone environments, demonstrating its ability to achieve significant suppression with five times fewer mosquitoes. To pilot the technology in the US, Oxitec is working with the US Environmental Protection Agency (EPA) leadership on its Experimental Use Permit (EUP) in preparation for implementing a pilot project in 2020 in Florida;

ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon, announced that following a review by the independent Data and Safety Monitoring Board (DSMB) it will progress to the next stage of the Phase Ib/IIa clinical trial for investigational drug AG019 for the treatment of early onset type 1 diabetes (T1D). ActoBio Therapeutics has initiated enrollment of the next two patient cohorts of the study: AG019 dosing in patients 12-17 years of age and combination dosing of AG019 plus teplizumab in adults;

Triple-Gene LLC has proceeded to enrollment of the second cohort of the Phase 1 clinical trial of INXN-4001, an investigational new drug which is the world’s first triple effector gene drug candidate being evaluated for the treatment of heart failure, following review of the first cohort data by the DSMB;

Intrexon Laboratories Hungary and Surterra Wellness (Surterra) partnered in an exclusive global licensing agreement to advance Surterra’s cannabinoid production at a reliable, efficient, cost-effective, industrial scale utilizing Intrexon’s proprietary yeast fermentation platform. The deal, including milestones and royalties, will leverage each company’s expertise to ultimately bring new legal and ethical cannabinoid products to market to meet growing demand, boost innovation, and improve product development;

Intrexon announced it is advancing its non-browning GreenVenus Romaine lettuce to commercial-size production trials as initial data under commercial indoor production conditions indicate that it has improved shelf-life up to 2 weeks and a potential for higher marketable yield with no tip burn. Non-browning GreenVenus lettuce has also been assessed by the United States Department of Agriculture and determined not to be subject to regulation under 7CFR Part 340 for plants altered or produced through genetic engineering; and

Intrexon entered into a nonbinding letter of intent, and received a nonrefundable cash deposit, for the sale of Exemplar Genetics, a wholly owned subsidiary of Intrexon focused on developing miniature swine models of human disease. The transaction is expected to close within the next thirty days pending completion of diligence.

Second Quarter 2019 Financial Highlights:

Total revenues of $36.0 million;

Net loss of $38.8 million attributable to Intrexon, or $(0.25) per basic share, including non-cash charges of $8.0 million; and

Cash, cash equivalents, and short-term investments totaled $125.8 million and the value of common equity securities totaled $21.5 million at June 30, 2019.

First Half 2019 Financial Highlights:

Total revenues of $59.3 million;

Net loss of $99.5 million attributable to Intrexon, or $(0.65) per basic share, including non-cash charges of $28.2 million.

"Earlier this year we announced our intent to focus the Company’s business, directing capital to certain of our most strategic programs. We also established a goal of ending the year with approximately the same net cash and short-term investment position that the company held on April 3, 2019, which included initiating plans to sell or partner certain divisions and to reduce our original 2019 operating budget by approximately $70 million," commented Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon.

Mr. Kirk concluded, "Based on the significant steps we have taken with respect to the sales of certain subsidiaries and assets, the partnering of programs, as well as operating cost reductions, we continue to believe our goal with respect to achieving the same net cash and short-term investment position should be achieved. Moreover, I believe we will meet this goal while retaining for the company the core technologies and valuable product candidates that represent the most important future value for our shareholders."

"We have identified and implemented significant operating cost reductions. However, based on progress to date and the ongoing evaluation of the Company’s strategic direction and long-term best interest, management has determined not to proceed in continuing its efforts to achieve the full initial target of $70 million in operating cost reductions. Instead, we will concentrate our focus on our overall net cash and short-term investment position," added LTG (Ret.) Thomas Bostick, PhD, PE, Chief Operating Officer of Intrexon and President, Intrexon Bioengineering.

There are risks and uncertainties inherent in forecasts of this nature, including with respect to the challenges in identifying and negotiating with counterparties, transactions taking longer or generating lower proceeds than expected, changes in strategic directions, general market developments, costs and expenses being higher than anticipated, developments in clinical, market or competitive data, and other factors of the type generally applicable to the Company’s business, including those discussed under the Safe Harbor Statement below.

With regard to the agreement to build a standalone energy company to be led by Governor Dewhurst on the foundation of Intrexon’s Methane Bioconversion Platform, Mr. Kirk further commented,

"Governor Dewhurst brings a lifetime of experience that perfectly suits him to lead the revolution in energy that should be made possible through our Methane Bioconversion Platform. From his experience as an intelligence officer, in public service (including serving as Lieutenant Governor of Texas for twelve years) and in building successful energy companies, he has throughout demonstrated leadership, intelligence, courage and personal integrity that inspire and that achieve significant results. We look forward to his leadership at MBP and to working with him to fully realize its great potential."

"As I have followed Intrexon, I have learned to admire and respect RJ’s acumen and visionary creation to improve the quality of life for all people. As an innovator, who has repeatedly implemented technologies successfully, I feel driven to seize this opportunity to work alongside RJ and the incredibly talented team as CEO of the Methanotroph Bioconversion Platform, to build a safer, healthier planet, and a more promising future. I’m excited by this opportunity and dedicated to bringing together great minds in synthetic biology with industry to solve big challenges facing today’s society," Governor Dewhurst stated.

Second Quarter 2019 Financial Results Compared to Prior Year Period

Total revenues decreased $9.3 million from the quarter ended June 30, 2018. Collaboration and licensing revenues decreased $8.4 million, or 48%, from the quarter ended June 30, 2018 primarily due to the reacquisition of rights previously licensed to some of our most significant collaborators in the second half of 2018 and the result of which eliminated or substantially reduced revenues previously generated from those collaborations.

Research and development expenses decreased $7.5 million, or 18%. The 2018 amounts include $5.3 million of one-time costs associated with closing one of Oxitec’s research and development facilities as the Company decentralized operations previously conducted in this facility. Additionally, depreciation and amortization decreased $2.2 million primarily due to intangible assets that were impaired or abandoned in 2018. Selling, general and administrative (SG&A) expenses decreased $12.9 million, or 38% and of this amount, $10.6 million was primarily attributable to decreased share-based compensation expense which arose primarily from the departure of former employees.

First Half 2019 Financial Results Compared to Prior Year Period

Total revenues decreased $25.6 million from the six months ended June 30, 2018. Collaboration and licensing revenues decreased $22.2 million, or 60%, from the six months ended June 30, 2018 primarily due to the reacquisition of rights previously licensed to some of our most significant collaborators in the second half of 2018 and the result of which eliminated or substantially reduced revenues previously generated from those collaborations. Product revenues decreased $4.0 million, or 24%, primarily due to lower customer demand for pregnant cows, live and weaned calves, and cloned products. Gross margin on products declined in the current period as a result of fewer products sold, decreased sales prices, and increased costs associated with new product offerings.

Research and development expenses decreased $11.6 million, or 15%. The 2018 amounts include $5.3 million of one-time costs associated with closing one of Oxitec’s research and development facilities as the Company decentralized operations previously conducted in this facility. Additionally, depreciation and amortization decreased $4.3 million primarily due to intangible assets that were impaired or abandoned in 2018. Research and development salaries, benefits and other personnel costs decreased $2.0 million primarily due to the closing of one of Oxitec’s research and development facilities. SG&A expenses decreased $19.1 million, or 26% and of this amount, $15.5 million was primarily attributable to decreased share-based compensation expense which arose primarily from the departure of former employees.

Conference Call and Webcast

The Company will host a conference call today Thursday, August 8th, at 5:30 PM ET to discuss the second quarter and first half 2019 financial results and provide a general business update. The

conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 4443860 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

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.