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Madrigal Pharmaceuticals Reports 2019 Second Quarter Financial Results and Highlights

On August 7, 2019 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) reported its second quarter 2019 financial results and highlights (Press release, Synta Pharmaceuticals, AUG 7, 2019, View Source [SID1234538288]):

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Madrigal has continued to progress on several important fronts during the second quarter. We have moved forward with our Phase 3 study of MGL-3196 (resmetirom) in patients with biopsy-proven non-alcoholic steatohepatitis (NASH) and liver fibrosis (MAESTRO-NASH)," stated Paul Friedman, M.D., Chief Executive Officer of Madrigal. "We were also fortunate to add Jim Daly to our Board of Directors. Jim’s deep commercial expertise will be invaluable as we move forward with development of resmetirom in NASH and Non-Alcoholic Fatty Liver Disease (NAFLD). In addition, in recognition of our clinical development progress and corresponding growth of the Company, we promoted Becky Taub, M.D., to President of R&D."

Becky Taub, M.D.,CMO, President, Research & Development of Madrigal, added, "Madrigal is enrolling patients in our MAESTRO-NASH Phase 3 clinical study, and although it’s early in the process, we are encouraged by the rate of site openings and patient screening numbers. We are also pleased to announce that our abstract "Effects of Resmetirom (MGL-3196) on Hepatic Fat, Lipids, Liver Enzymes and Markers of Liver Fibrosis in an Open-Label 36-Week Extension Study in NASH Patients" has been selected for oral presentation at the Liver Meeting AASLD 2019 in Boston, November 2019. A poster, "Steatosis and Fibrosis Measured as Continuous Variables on Paired, Serial Liver Biopsies in the Resmetirom (MGL-3196) 36-Week Phase 2 NASH Study" will also be presented at AASLD meeting."

Additional information about Madrigal’s Phase 3 study in patients with NASH [NCT03900429] can be obtained at www.clinicaltrials.gov.

Financial Results for the Three and Six Months Ended June 30, 2019

As of June 30, 2019, Madrigal had cash, cash equivalents and marketable securities of $466.4 million, compared to $483.7 million at December 31, 2018. Cash used in operating activities during the first six months of 2019 was $18.0 million.

Operating expenses were $22.7 million and $40.8 million for the three and six month periods ended June 30, 2019, compared to $7.8 million and $14.9 million in the comparable prior year periods.

Research and development expenses for the three and six month periods ended June 30, 2019 were $15.6 million and $28.0 million compared to $5.1 million and $10.3 million in the comparable prior year periods. The increase is primarily attributable to additional activities related to initiation of our Phase 3 clinical trial in NASH, including a payment due related to a milestone achieved under our agreement with Roche, an increase in headcount and increased non-cash stock compensation from stock option awards.

General and administrative expenses for the three and six month periods ended June 30, 2019 were $7.1 million and $12.9 million compared to $2.7 million and $4.6 million in the comparable prior year periods. The increase is due primarily to higher non-cash stock compensation expense from stock option awards.

Interest income for the three and six month periods ended June 30, 2019 was $3.0 million and $6.0 million compared to $1.2 million and $1.9 million in the comparable prior year periods. The change in interest income was due primarily to a higher average principal balance in our investment portfolio in 2019, and increased interest rates.

About resmetirom (MGL-3196)

Among its many functions in the human body, thyroid hormone, through activation of its beta receptor, plays a central role in controlling lipid metabolism, impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Attempts to exploit this pathway for therapeutic purposes in cardio-metabolic and liver diseases have been hampered by the lack of selectivity of older compounds for the thyroid hormone receptor (THR)-ß, chemically-related toxicities and undesirable distribution in the body.

Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-ß and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-ß agonism. Madrigal believes that resmetirom is the first orally administered, small-molecule, liver- directed, truly ß-selective THR agonist.

Based on the positive Phase 2 clinical study results in patients with NASH (Phase 2 36-Week Results Press Release), Madrigal initiated a Phase 3 multinational, double-blind, randomized, placebo-controlled study of resmetirom in patients with non-alcoholic steatohepatitis (NASH) and fibrosis to resolve NASH and reduce progression to cirrhosis and/or hepatic decompensation (Phase 3 Initiation Press Release and ClinicalTrials.gov NCT03900429). Additionally, in both the NASH Phase 2 study, and a second positive Phase 2 clinical study in patients with heterozygous familial hypercholesterolemia (Phase 2 HeFH Results Press Release), significant reductions in multiple atherogenic lipids were observed. As a result, Madrigal is designing a Phase 3 study intended to treat the prevalent dyslipidemias in NAFLD and NASH patients and improve the fatty liver phenotype in this population.

Onconova Therapeutics, Inc. to Provide Corporate Update and Second Quarter 2019 Financial Results

On August 7, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), reported that the Company will release its second quarter financial results on August 14, 2019, before the market opens (Press release, Onconova, AUG 7, 2019, View Source [SID1234538269]). The Company will host a conference call on August 14, 2019, at 9 a.m. Eastern Time to discuss these results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S. or (210) 229-8823 internationally and using conference ID 9150777. The call will also be webcast live. Please click here to access the webcast on the Investor Relations page of the Company’s website. A replay will be available for 90 days.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress to the development of acute leukemia.

SURFACE ONCOLOGY REPORTS FINANCIAL RESULTS AND CORPORATE HIGHLIGHTS FOR SECOND QUARTER 2019

On August 7, 2019 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the second quarter of 2019 (Press release, Surface Oncology, AUG 7, 2019, View Source [SID1234538265]).

"We are pressing forward at Surface on our mission to Break Through for patients with cancer, and we are excited to be entering the second half of 2019 where you will begin to see some of the results of our hard work. SRF617 and SRF388 remain on track for IND filings later this year. Furthermore, we anticipate multiple poster presentations at SITC (Free SITC Whitepaper) highlighting a number of our pipeline programs, as well as hosting our first ever research and development day in November where executives from Surface, as well as key opinion leaders, will discuss our programs," said Jeff Goater, chief executive officer of Surface Oncology.

Recent & Upcoming Corporate Highlights:

Presented preclinical data further supporting the anti-tumor mechanisms for SRF617 (targeting CD39; currently in IND-enabling studies) and NZV930 (targeting CD73; currently in phase 1) at the Brisbane Immunotherapy 2019 Conference in May.

The ongoing phase 1b study of NZV930 (CD73), licensed to Novartis, is continuing to enroll and is evaluating combinations of NZV930 with PDR001 (anti PD-1), NIR178 (A2aR inhibitor), as well as a triplet combination of all three therapies. Novartis is paying for all development costs associated with NZV930. Surface Oncology is currently entitled to cumulative potential milestones in excess of $500 million, as well as tiered royalties on annual net sales by Novartis ranging from high single-digit to mid-teens percentages upon the successful commercialization of NZV930.

Submitted multiple abstracts for presentation at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference discussing data from the SRF617, SRF388 and SRF231 programs.

Announced the inaugural Surface Oncology Research and Development Day in New York City on Monday, November 18th, 2019, at the Nasdaq MarketSite in Times Square. Presenters will include members of Surface’s executive management, as well as key opinion leaders in the field of immuno-oncology. Topics will include deep dives into both SRF617 and SRF388, presentation of data and clinical trial designs, as well as the introduction of a newly nominated pipeline program.

Continued preparation to file Investigational New Drug applications for both SRF617 and SRF388 in Q4 of 2019. These filings will be staggered, with the IND for SRF617 to be filed first.

Financial Results:

As of June 30, 2019, cash, cash equivalents and marketable securities were $126.3 million, compared to $140.2 million on March 31, 2019.

Research and development (R&D) expenses were $13.2 million for the second quarter ended June 30, 2019, compared to $15.1 million for the same period in 2018. The decrease in expenditures was primarily driven by a reduction of CMC related spend on SRF231 (CD47) program, which was partially offset by increased spend on SRF617. R&D expenses included $0.6 million in stock-based compensation expense for the second quarter of 2019.

General and administrative (G&A) expenses were $5.4 million for the second quarter ended June 30, 2019, compared to $3.9 million for the same period in 2018. The increase in G&A expenses is primarily due to increased personnel costs and professional fees associated with the growth of the Company and operating as a public company. G&A expenses included $0.9 million in stock-based compensation expense for the second quarter of 2019.

For the second quarter ended June 30, 2019, net loss was $17.8 million, or basic and diluted net loss per share attributable to common stockholders of $0.64. Net loss was $15.9 million for the same period in 2018 or diluted net income per share attributable to common stockholders of $0.73.

Financial Outlook:

Based upon its current operating plan, which includes anticipated milestones from Novartis, Surface continues to have a projected cash runway through 2021.

Epigenomics AG Highlights Operational Achievements and Reports Financial Results for First Six Months 2019

On August 7, 2019 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported the operational achievements plus financial results for the second quarter and the first half of 2019 (Press release, Epigenomics, AUG 7, 2019, View Source [SID1234538264]).

Operational highlights

– In January 2019, the Company announced positive results from a microsimulation model for the Epi proColon blood test. The results are awaiting publication.

– In March, the bipartisan "Donald Payne Sr. Colorectal Cancer Detection Act" (HR 1765) was reintroduced into the U.S. House of Representatives. In the meantime, the law has won numerous supporters in both parties and especially in the key committees of Congress. The latter is of great importance so that the law can be voted on – if not individually, then as part of a legislative package.

– On May 3, 2019, the Centers for Medicare & Medicaid Services (CMS) accepted the Company’s application to review Epi proColon as part of a National Coverage Determination (NCD). Once the review process has been opened, there is a statutory timeframe of maximum nine months within which CMS must have reached a decision and Epigenomics therefore has clarity regarding the reimbursement of Epi proColon.

6M 2019 Financial results
– In the first half of 2019, product revenue increased by 84% year-on-year to EUR 660 thousand.

– License revenue decreased to EUR 19 thousand (6M 2018: EUR 413 thousand) due to the termination of the collaboration with the Chinese licensing partner.

– Total revenue in the first six months of 2019 decreased from EUR 771 thousand to EUR 679 thousand compared to the same period in the prior year due to lower license revenue, which were not fully offset by higher product revenue.

– Research and development costs increased from EUR 3,043 thousand in the previous year to EUR 3,867 thousand. This increase resulted from expenses related to the post-approval study for Epi proColon and the HCC (liver cancer test) study in the U.S.

– Selling and administrative expenses rose by from EUR 3,883 thousand to EUR 4,859 thousand in the reporting period, due to an increase in sales and marketing activities related increased product revenue and commercial preparation of reimbursement coverage.

– Overall, operating costs were lower than estimated for the first six months of 2019. Operating expenses increased from EUR 7.1 million to EUR 9.4 million compared to prior year for the abovementioned reasons.

– Adjusted EBITDA (before share-based payment expenses) was EUR -7.2 million in the first six months of 2019 compared to EUR -5.4 million for the same period prior year.

– The net loss for the period was EUR -7.4 million vs. EUR -5.8 million for the prior year; the loss per share decreased to EUR 0.21 (6M 2018: EUR 0.24) due to the higher number of outstanding shares following the capital increase carried out in the second half of 2018.

– Cash consumption from operating activities increased by EUR 3.6 million to EUR 7.8 million in the first half of 2019 due to higher operating costs.

– As of June 30, 2019, liquidity amounted to EUR 9.1 million (including marketable securities) compared to EUR 17.1 million at year-end 2018.

Greg Hamilton, CEO of Epigenomics AG: "We continue to make progress on CMS reimbursement. CMS’s acceptance of our NCD is an important milestone. While the process of opening the NCD is taking longer than we would like we still remain optimistic and will continue to pursue all available paths to achieve coverage for Epi proColon."

Outlook 2019: revenue forecast adjusted
Revenue

– Due to the delays in the reimbursement decision in the U.S. described above, the revenue forecast has been adjusted from between EUR 3.0 million and EUR 6.0 million to between EUR 2.0 million and EUR 4.0 million.

EBITDA / Cash consumption

– Epigenomics AG specifies its guidance for adjusted EBITDA (before share-based payment expenses). For the full year 2019, the Company expects an adjusted EBITDA within the range of EUR -12.5 million to EUR -14.0 million. Cash consumption is expected to be within a range of EUR -13.5 million to EUR -15.0 million, due to payments in the first quarter of 2019 for which the corresponding expenses had already been incurred in 2018.

Further information
The financial report for the first six months of 2019 is available on the Epigenomics website: View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference call for analysts and investors
Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed on the Company’s website: View Source
The dial-in numbers for the conference call are:
Dial-in number Germany: +49 30 232 531 411
Dial-in number UK: +44 1635 598 060
Dial-in number USA: +1 516-269-8983
Participants are kindly asked to dial in 10 minutes prior to the start of the call.
An audio replay of the conference call will be provided on the Epigenomics’ website subsequently.

ArQule Reports Second Quarter 2019 Financial Results

On August 7, 2019 ArQule, Inc. (Nasdaq: ARQL) reported its financial results for the second quarter of 2019 (Press release, ArQule, AUG 7, 2019, View Source [SID1234538263]).

For the quarter ended June 30, 2019, the Company reported a net loss of $9.1 million, or $0.08 per basic share, compared with net income of $5.2 million, or $0.05 per diluted share, for the quarter ended June 30, 2018.

As of June 30, 2019, the Company had a total of approximately $182.8 million in cash, cash equivalents, and marketable securities.

Key Highlights from Q2, 2019

In June 2019, the Company raised approximately $104 million of gross proceeds in a public offering of common stock. Net proceeds will be used to fund clinical programs and for general corporate purposes
ARQ 531, our potent and reversible dual inhibitor of both wild-type and C481S-mutant BTK.
Presented first-of-its kind clinical proof-of-concept data at the 2019 European Hematology Association (EHA) (Free EHA Whitepaper) Annual meeting from the ongoing phase 1 trial, including 4 Partial Responses (PRs) out of 6 evaluable CLL patients in the 65 mg QD dose cohort, a PR in a Richter’s transformation patient at the same dose and a PR in a follicular lymphoma patient on therapy for approximately two years. Subsequent to the EHA (Free EHA Whitepaper) presentation an additional PR was observed in a DLBCL patient and was disclosed in the context of the recent public offering
Selected 65 mg QD as the recommended starting phase 2 dose (RP2D) after assessing incremental clinical activity and tolerability data from cohorts 7 (65 mg QD) and 8 (75 mg QD); no additional dose limiting toxicities have been observed and a maximum tolerated dose has not been reached
Commenced preparations for the next phase of development, including planned regulatory interactions and design of expansion cohorts at the RP2D in multiple B-Cell malignancies, including C481S mutant CLL
Miransertib, our potent and selective first-generation AKT inhibitor.
Presented updated Proteus syndrome and PIK3CA-related Overgrowth Spectrum (PROS) data at the 2019 European Society of Human Genetics conference in Gothenburg, Sweden
Finalized the registrational protocol, received initial IRB approvals, nearing dosing of first patient
ARQ 751, our highly potent and selective next-generation AKT inhibitor.
Continued the signal generation work in genetically-defined solid tumors
Derazantinib, our FGFR inhibitor, partnered with Basilea and Sinovant, in a registrational trial for intrahepatic cholangiocarcinoma.
Clinical activities ongoing with our partners, Basilea and Sinovant
Paolo Pucci, Chief Executive Officer of ArQule, commented, "Our second quarter was punctuated by the proof-of-concept data presented at EHA (Free EHA Whitepaper) for ARQ 531, and we are gratified that our recent public offering will allow us to pursue the next phase of clinical development with ARQ 531."

"Having observed substantial clinical activity with ARQ 531 at a well-tolerated dose in the target populations, we have been able to select a phase 2 dose and are aggressively taking the drug into the expansion phase," commented Dr. Brian Schwartz, Chief Medical Officer of ArQule. "We are also excited to have opened additional sites in our registrational MOSAIC study in Proteus syndrome and PROS."

Revenues and Expenses

Revenues for the second quarter, 2019, were $0.3 million compared with revenues of $13.7 million for the second quarter, 2018.

Research and development expenses in the second quarter, 2019 were $6.3 million compared with $6.8 million for the second quarter, 2018.

General and administrative expenses in the second quarter, 2019 were $3.2 million compared with $2.2 million for the second quarter, 2018.

2019 Financial Guidance

For 2019, ArQule expects revenue to range between $3 and $5 million. Net loss is expected to range between $40 and $43 million, and net loss per share to range between $(0.35) and $(0.37) for the year. As a result of our common stock offering in June, we are updating our cash guidance. ArQule now expects to end 2019 with approximately $160 million in cash and marketable securities which will support the current business plan into 2022.

Conference Call and Webcast

ArQule will hold its second quarter financial results call today, August 7, 2019 at 9:00 a.m. ET. The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events and Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events and Presentations."