On May 9, 2018 Epigenomics AG (FSE: ECX, OTCQX: EPGNY), or the "Company", reported its financial results for the first quarter 2018 ended March 31 (Press release, Epigenomics, MAY 9, 2018, View Source [SID1234526298]).

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Q1/2018 Financial results

-Total revenue slightly increased to EUR 309 thousand (Q1 2017: EUR 281 thousand) due to higher product sales (+38%).

-Operating costs increased to EUR 3.6 million (Q1 2017: EUR 3.1 million), mainly due to higher R&D expenses for the FDA required Epi proColon post approval study.

-Operating loss (EBIT) increased to EUR 3.3 million (Q1 2017: EUR 2.7 million). EBITDA (loss) before expenses for share-based compensation increased to EUR 3.2 million (Q1 2017: EUR 2.4 million).

-Net loss increased to EUR 3.2 million (Q1 2017: EUR 2.4 million). Loss per share increased to EUR 0.13 (Q1 2017: EUR 0.10).

-Cash consumption increased to EUR 2.4 million (Q1 2017: EUR 1.6 million).

-The Company’s liquidity (cash, cash equivalents and marketable securities) at the reporting date was EUR 11.2 million (Dec 31, 2017: EUR 13.7 million).

Operational highlights

-Senators Capito and Heinrich Introduce Bi-Partisan Colorectal Cancer Detection Bill: Senators Shelley Moore Capito (R -WV) and Martin Heinrich (D – NM), introduced the "Colorectal Cancer Detection Act of 2018" to the United States Senate in Washington D.C. This Senate Bill (S. 2523) is parallel to House Bill (H.R. 1578) "Donald Payne Sr. Colorectal Cancer Detection Act" introduced by Congressman Donald M. Payne, Jr. (D – NJ). These bipartisan initiatives aim to provide payment and coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood-based tests.

-Blood test shows promise in the detection of liver cancer: Results from two clinical studies published in EBioMedicine supported by Cell Press and The Lancet, demonstrated high accuracy of Epigenomics’ proprietary epigenetic circulating biomarker mSEPT9 in detecting liver cancer among patients with cirrhosis. In the studies, the mSEPT9 test exhibited higher diagnostic accuracy than the currently established diagnostic marker. A further independent, prospective clinical study with 440 patients was initiated.

Outlook 2018 confirmed

-The Company confirms the outlook for the financial year 2018 as provided in the Annual Report 2017 published on March 23, 2018.

-Overall, we expect that revenue will increase but will remain on low levels, ranging between EUR 2.0 million and EUR 4.0 million.

-We anticipate that EBITDA before share-based payment expenses will be in a range EUR -11.5 million and EUR -14.0 million in 2018.

Further Information

The report on the first quarter 2018 can be downloaded from Epigenomics’ website at:
View Source

Conference call for analysts and investors

The Company will host a conference call and webcast at 3.30 pm CET / 9.30 am EDT, today. The presentation can be followed on the Company’s website.

The dial-in numbers for the conference call are:

Germany: +49 30 232531428
UK: +44 1635 598062
USA: +1 516-269-8980

The webcast will be made available on: View Source;lang=en

An audio replay of the conference call will be provided on Epigenomics’ website subsequently.

On May 9, 2018 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported that Natalie Holles, President and Chief Operating Officer, will present at the Bank of America Merrill Lynch Health Care Conference in Las Vegas, NV (Press release, Audentes Therapeutics, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348070 [SID1234526345]). The presentation is scheduled for Wednesday, May 16, 2018, at 11:20 am PT.

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To access a live webcast of the presentation, please visit the Events & Presentations page within the Investors + Media section of the Audentes website. A replay of the live webcast will be available on the Audentes website for approximately 30 days following the conference.

On May 9, 2018 Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results and provided a corporate update for the quarter ended March 31, 2018 (Press release, Jounce Therapeutics, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348006 [SID1234526375]).

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"The first quarter of 2018 has marked a time of consistent progress for our JTX-2011 clinical program and preclinical pipeline," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We remain focused on our key value drivers that we set forth at the start of 2018 as we work to transform the cancer treatment paradigm by delivering immunotherapies with long-lasting benefits. The current unmet medical need for many cancer types remains high and Jounce is committed to understanding the tumor microenvironment and how to interrogate it in meaningful and successful ways."

Upcoming Clinical Milestones and Research Highlights:

Jounce will report preliminary efficacy data from two ICONIC Phase 2 combination cohorts, gastric cancer and triple negative breast cancer, at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Jounce remains on track to initiate a JTX-2011 and CTLA-4 inhibitor combination arm of ICONIC, starting with safety dose escalation, and expects to provide further updates this year.
In April 2018, Jounce presented two posters at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data, from genomic and histology-based nonclinical translational studies, identified ICOS as a potential target for therapeutic intervention for gastric cancer and triple negative breast cancer, supporting the inclusion of these cancer types in the ongoing ICONIC trial.
Jounce remains on track to file an Investigational New Drug (IND) application for JTX-4014, its internal anti-PD-1 antibody in 2018.
Jounce announced that it advanced its first, tumor associated macrophage candidate from its Translational Science Platform into IND-enabling studies.
First Quarter 2018 Financial Results:

Cash Position: As of March 31, 2018, cash, cash equivalents and investments were $237.2 million, compared to $257.9 million as of December 31, 2017. This decrease was due to operating costs incurred during the quarter.
Collaboration Revenue: Collaboration revenue was $11.2 million for the first quarter of 2018, compared to $20.3 million for the same period in 2017. Collaboration revenue represents revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene. The decrease in collaboration revenue was primarily due to the adoption of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606). Under ASC 606, Jounce has transitioned from recognizing revenue on a straight-line basis to recognizing revenue based on the pattern of performance under the global strategic collaboration with Celgene.
Research and Development (R&D) Expenses: R&D expenses were $18.2 million for the first quarter of 2018, compared to $15.0 million for the same period in 2017. The increase in R&D expenses was primarily due to $1.4 million in increased employee compensation costs related to increased headcount, $0.8 million in increased clinical and regulatory costs related to the Phase 1/2 ICONIC study of JTX-2011 and $0.7 million in increased external research and development costs, primarily attributable to IND enabling activities related to JTX-4014.
General and Administrative (G&A) Expenses: G&A expenses were $6.8 million for the first quarter of 2018, compared to $5.6 million for the same period in 2017. The increase in G&A expenses was primarily due to $0.9 million in increased employee compensation costs primarily related to stock-based compensation expense and $0.4 million in increased professional services fees primarily attributable to operating as a public company.
Net (Loss) Income: Net loss was $13.0 million for the first quarter of 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.40. Net income was $0.4 million for the same period in 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.02 as a result of preferred stock dividends that were accrued prior to the completion of Jounce’s initial public offering. The increase in net loss per share attributable to common stockholders is primarily attributable to the decrease in collaboration revenues and the increase in operating expenses from the first quarter of 2017 to the first quarter of 2018.
Financial Guidance:

Based on its current plans, Jounce continues to expect cash burn on operating expenses and capital expenditures for the full year 2018 to be approximately $80.0 million to $100.0 million and expects to record approximately $50.0 million to $60.0 million in collaboration revenue in 2018 from the recognition of the Celgene upfront payment received in 2016.

Given the strength of its balance sheet, Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 3760478. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

Cautionary Note Regarding Forward-Looking Statements:

Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding operating expenses, capital expenditures, collaboration revenue and other financial results, release of data from the Phase 1/2 ICONIC trial, expansion of the JTX-2011 program, the filing of an IND for JTX-4014 and the timing, progress and results of preclinical studies and clinical trials for Jounce’s product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward looking statements, which often include words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "on track," "plan," "predict," "target," "potential" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates, the preclinical and clinical results for its product candidates, which may not support further development and marketing approval, the potential advantages of Jounce’s product candidates, the development plans of its product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Jounce’s ability to obtain, maintain and protect its intellectual property, Jounce’s ability to manage operating expenses, Jounce’s ability to maintain its collaboration with Celgene, as well as those risks more fully discussed in the section entitled "Risk Factors" in Jounce’s most recent annual or quarterly report and in other reports that Jounce has filed with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

On May 9, 2018 Selecta Biosciences, Inc. (NASDAQ:SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported financial results for the first quarter ended March 31, 2018 and provided a corporate update (Press release, Selecta Biosciences, MAY 9, 2018, View Source [SID1234526391]).

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"We are very pleased by the clinical activity seen in the SEL-212 phase 2 data presented recently at PANLAR, not only in SEL-212’s ability to control serum uric acid levels with convenient monthly doses, but also in the reduced incidence of gout flares compared to the current FDA-approved uricase. We have two more anticipated data readouts from this trial at EULAR and a medical conference in the third quarter and we are also planning to initiate the Phase 3 program later this year," said Werner Cautreels, Ph.D., President and CEO of Selecta. "And now that our next program, SEL-403, has entered the clinic for the treatment of patients with mesothelioma at the National Cancer Institute, we have demonstrated the versatility of our tolerance SVP platform in an additional therapeutic area of high unmet need. SEL-403 is the first non-immunogenic immunotoxin that targets mesothelin on cancer cells providing the possibility of improving efficacy and safety for a broad group of cancer patients."

Recent Business Highlights and Activities

Presented Positive New Data from Ongoing Phase 2 Trial of SEL-212 at PANLAR 2018 Congress in April: In April 2018, Selecta presented new data from patients receiving SEL-212 for the treatment of chronic severe gout at the Pan American League of Associations for Rheumatology (PANLAR) 2018 Congress in Buenos Aires, Argentina. The data was generated from patients that received three monthly doses of SEL-212, up to 0.15 mg/kg of SVP-Rapamycin in combination with 0.2 or 0.4 mg/kg of pegsiticase, followed by two monthly doses of pegsiticase alone. Approximately 75% of evaluable patients maintained serum uric acid level control below 6 mg/dl during the initial three months of therapy with concurrent mitigation of anti-drug antibodies (ADAs) against the pegsiticase enzyme. Furthermore, 91% of patients dosed with pegsiticase alone in month four after the initial three monthly doses of SEL-212 maintained serum uric acid control. The company plans to present an expanded data set of the PANLAR cohorts at the EULAR conference on June 15th and will host a conference call to discuss the data on June 15th at 8.30 am.

Data from Cohorts Receiving Five Combination Doses in Phase 2 Trial of SEL-212 to be Presented in the Third Quarter at a Medical Meeting: In February 2018, Selecta began enrolling new cohorts of patients in the current Phase 2 trial who are expected to receive five monthly doses of SVP-Rapamycin in combination with pegsiticase. These patients are receiving SVP-Rapamycin doses ranging from 0.1mg/kg-0.15mg/kg in combination with 0.2 mg/kg of pegsiticase. The company expects to present data from these patients at an upcoming medical meeting in the third quarter of 2018.

SEL-212 to Enter Phase 3 in 2018 Following Comprehensive Dose Selection Trial:Selecta is actively engaged in preparations for an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), which will define the company’s design for the Phase 3 program. The company plans to initiate its Phase 3 program in 2018.

Patient Enrollment Ongoing for SEL-403 Phase 1 Trial for Mesothelioma: In March 2018, the first patient was dosed in a Phase 1 clinical trial of SEL-403, Selecta’s combination product candidate consisting of SVP-Rapamycin and LMB-100, for the treatment of patients with malignant pleural or peritoneal mesothelioma who have undergone at least one regimen of chemotherapy. LMB-100, which was in-licensed by Selecta in 2017, is a recombinant immunotoxin that targets mesothelin, a protein expressed in nearly all mesotheliomas and pancreatic adenocarcinomas, and a high percentage of other malignancies, including lung, breast and ovarian cancers. This open-label dose-escalation Phase 1 trial is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health, and is expected to enroll at least 18 patients. The trial will evaluate the safety and tolerability of this treatment and provide data on pharmacokinetics, ADA levels, as well as an objective response rate assessment.
First Quarter Financial Results:

Revenue: For the first quarter of 2018, the company recognized no revenue, which compares with $0.1 million for the first quarter of 2017. The decline is the result of reduced revenue recognized from the company’s grants and collaborations.

Research and Development Expenses: Research and development expenses for the first quarter of 2018 were $11.1 million, relatively unchanged from the $11.0 million for the first quarter of 2017.

General and Administrative Expenses: General and administrative expenses for the first quarter of 2018 were $4.7 million, which compares with $3.9 million for the first quarter of 2017. The increase is primarily the result of greater headcount and related salaries needed to support a maturing clinical-stage public company.

Net Loss: For the first quarter of 2018, Selecta reported a net loss attributable to common stockholders of $(15.9) million, or $(0.71) per share, compared to a net loss of $(15.1) million, or $(0.82) per share, for the same period in 2017.

Cash Position: Selecta had $83.5 million in cash, cash equivalents, short-term deposits, investments and restricted cash as of March 31, 2018, which compares with a balance of $97.0 million at December 31, 2017. Selecta continues to expect that its cash, cash equivalents, short-term deposits, investments and restricted cash will be sufficient to fund the company’s operating expenses and capital expenditure requirements into mid-2019.
Conference Call Reminder
Selecta management will host a conference call at 8:30 a.m. ET today to announce the company’s first quarter financial results and provide a corporate update. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10118841.

On May 9, 2018 Chia Tai Tianqing Pharmaceutical Group reported the 1.1-type new drug Anlotinib Hydrochloride Capsules (Focavi) obtained the registration approval document approved by the State Drug Administration (Press release, Jiangsu Chia-tai Tianqing, MAY 9, 2018, View Source [SID1234576212]). This marks the official launch of Anlotinib, an original and innovative drug in the Chinese oncology field that has received much attention. Wang Shanchun, president of CP Tianqing Pharmaceutical Group, said: "We expect that this new national drug will benefit more Chinese patients and even patients around the world after it is launched."

Anlotinib refers to advanced non-small cell lung cancer

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After more than 10 years of hard work, the R&D team of CP Tianqing finally made a breakthrough in the development of oncology drugs. The 1.1-type new drug Anlotinib Hydrochloride Capsules was approved for marketing. This product is a new type of small molecule multi-target tyrosine kinase inhibitor, which can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit and other kinases, and has the dual effects of anti-tumor angiogenesis and inhibiting tumor growth. Clinical trials have confirmed that Focavi is the only effective single-drug oral preparation among the anti-angiogenesis targeted drugs for advanced non-small cell lung cancer, and its adverse reactions are relatively mild, and it is well tolerated by patients. According to analysis by industry experts, Anlotinib is expected to become the standard drug for the third-line treatment of patients with advanced non-small cell lung cancer.

"The listing of Anlotinib is also due to the ongoing reform measures for drug review and approval by the State Food and Drug Administration. As clinical studies have shown that Anlotinib has obvious clinical advantages over existing treatments, after the application That is, it was included in the priority review sequence by the drug review center. It is precisely because of the attention of the drug review department and the review experts working overtime that Anlotinib completed the marketing review and was approved in a short period of time. This will enable the majority of patients to use safe and effective anti-tumor innovative drugs as soon as possible." Wang Shanchun believes that the drug review period coincides with the national drug review and approval policy reform period, and the country’s orientation to encourage R&D and innovation is becoming more and more obvious. The approval of innovative drugs with outstanding clinical value such as Anlotinib has been guaranteed and encouraged. Through the priority review procedure, the Center for Drug Evaluation has provided an effective guarantee for meeting clinical drug needs, reducing drug costs, and promoting public health.

The clinical research results show that Focavi not only has a good therapeutic effect on non-small cell lung cancer, but also on soft tissue sarcoma, ovarian cancer and other cancers. CT Tianqing is actively carrying out multi-center clinical research including the United States. . The results of the Phase 2b clinical study of Anlotinib in the treatment of soft tissue sarcoma were reported orally by ASCO (Free ASCO Whitepaper) this year, and the results of the pathological subgroup of the Phase 3 clinical study for the treatment of non-small cell lung cancer were displayed in the ASCO (Free ASCO Whitepaper) this year, and were written into the "2018 CSCO Lung Cancer Guidelines" . Wang Shanchun said: "It is not easy for China’s original innovative drugs to have won such an honor before they went on the market. This shows the international recognition of Chinese innovative drugs."

Malignant tumors are the unbearable weight of life

There are more than 4 million new cancer patients in China each year, and an average of more than 10,000 people are diagnosed as new patients every day, and the incidence rate is increasing year by year. In particular, lung cancer ranks first in morbidity and mortality among men, and second in morbidity and mortality among women. The five-year survival period of cancer patients is much lower than the average in developed countries.

As an ordinary citizen, once diagnosed with a malignant tumor disease, not only the patient himself will suffer both physical and mental torture, loss of hope of survival, loss of dignity of life, but also a family may be crushed by this, and bear a heavy burden from then on The unbearable spiritual and economic burden. As an enterprise with a social conscience, CP Tianqing is also working hard, hoping to one day conquer the persistent disease of malignant tumors through technological innovation.

In recent years, with the development of traditional chemotherapy, targeted therapy and immunotherapy have successively entered first-line and second-line treatment, and the treatment of advanced non-small cell lung cancer has been greatly improved. However, for Chinese patients who have failed first-line and second-line treatments, the existing third-line treatments are relatively lacking and the choices are confusing, and patients are often in the predicament of no medicines available. In this case, the new small molecule multi-target tyrosine kinase inhibitor anlotinib independently developed by CT Tianqing has finally succeeded, providing an effective new method for the third-line treatment of patients with advanced non-small cell lung cancer in China. treatment method.

CP Tianqing has a rich product line in the anti-tumor field

The listing of Anlotinib can be said to be a milestone event in the development history of CP Tianqing. The drug is Chia Tai Tianqing’s first innovative small molecule drug in accordance with international R&D procedures and standards, and it is also the company’s most invested anti-cancer drug so far. The successful listing of Anlotinib marks a solid step forward by CP Tianqing from "combination of imitation and innovation" to "combination of innovation and imitation". It is also a major breakthrough in the oncology field of the company based on the "focus on liver disease" strategy. .

Chia Tai Tianqing Pharmaceutical Group is an innovative pharmaceutical group enterprise integrating scientific research, production and sales. It is a well-known liver health drug research and development and production base in China. It is a national key high-tech enterprise and a national Torch Plan Lianyungang new pharmaceutical industry base. The backbone enterprise ranks 16th among the top 100 enterprises in China’s pharmaceutical industry. Chia Tai Tianqing currently invests more than 10% of its sales revenue every year. It has more than 1,000 R&D personnel and more than 180 products under research, including more than 40 innovative drugs and more than 20 biological drugs.

It is reported that in addition to the field of strong liver diseases, CP Tianqing has also formed a unique product line in the field of anti-tumor. Hematological tumor products Decitabine, Imatinib, and Dasatinib are the first imitation products in China. In the next three years, CP Tianqing will launch more products in the oncology field, such as bortezomib, bendamustine, lenalidomide, azacitidine, etc., to improve drug accessibility and quality of life for cancer patients.