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]).

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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.

On August 7, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported second quarter 2019 financial results (Press release, CytomX Therapeutics, AUG 7, 2019, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-second-quarter-2019-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-second-quarter-2019-financial" rel="nofollow">View Source [SID1234538301]).

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As of June 30, 2019, CytomX had cash, cash equivalents and short-term investments of $349.1 million.

"CytomX continues to make progress across its pipeline. Highlights of the second quarter included additional presentations of clinical data for our lead, wholly owned assets, CX-072 and CX-2009, which further demonstrated the potential of these two novel anti-cancer agents," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "Our clinical work to date with our lead programs provides validation for our unique approach to targeting antibody therapies to the tumor microenvironment and, accordingly, the discovery and development of new and differentiated treatments for cancer patients."

Business Highlights and Recent Developments

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program

CX-072 is a wholly owned Probody therapeutic targeting PD-L1, a clinically and commercially validated anti-cancer target.
CytomX presented updated clinical data from monotherapy expansion cohorts (Part D) of the PROCLAIM-CX-072 Phase 1/2 study, evaluating the safety and efficacy of CX-072 in multiple tumor types at 10 mg/kg at the 2019 Annual Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These data demonstrated a favorable safety profile and evidence of anti-cancer activity in certain patients with triple negative breast cancer, anal squamous cell carcinoma, cutaneous squamous cell carcinoma and undifferentiated pleomorphic sarcoma.
David Page, M.D., Medical Oncologist, Providence Cancer Center presented clinical data from PROCLAIM-CX-072 monotherapy and in combination with ipilimumab (YERVOY) as part of a Poster Discussion Session at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a wholly owned, first in class Probody drug conjugate (PDC) targeting CD166, a novel antigen that is broadly and highly expressed in many types of cancer.
CytomX reported preliminary data from the dose-escalation phase (Part A and A2) of the ongoing PROCLAIM-CX-2009 Phase 1/2 study, evaluating the safety and antitumor activity of CX-2009 in seven selected tumor types, at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CX-2009 was generally well tolerated. Single agent anti-cancer activity was observed in certain patients with breast cancer, ovarian cancer and head and neck cancer.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program

CX-2029 is a first in class PDC targeting CD71, the Transferrin Receptor, a highly efficient cellular mechanism for the internalization of antibody drug conjugates in preclinical models.
CD71 is widely expressed on normal tissues and therefore is considered to be an undruggable clinical target for conventional antibody drug conjugate technology.
CytomX discovered and is developing CX-2029 in collaboration with AbbVie to potentially turn CD71 into a druggable target.
CytomX continues to enroll patients in the PROCLAIM-CX-2029 Phase 1/2 study evaluating CX-2029 as monotherapy in patients with solid tumors or lymphomas.
BMS-986249 (CTLA-4 Probody Therapeutic) Clinical Program

Bristol-Myers Squibb (BMS) continues enrollment in a Phase 1/2 dose escalation clinical study evaluating BMS-986249 alone and in combination with OPDIVO (nivolumab) in solid tumors that are advanced and have spread.
BMS is preparing to initiate the Phase 2 portion of this clinical trial, upon which CytomX is entitled to a $10 million milestone payment.
AbbVie Second Target Selection Under Strategic Oncology Collaboration

In July 2019, CytomX announced its partner AbbVie selected a second target under the companies’ 2016 Discovery Collaboration and Licensing Agreement to discover and develop Probody drug conjugates. The target selection triggered a $10 million payment to CytomX.
Second Quarter 2019 Financial Results
Cash, cash equivalents and short-term investments totaled $349.1 million as of June 30, 2019, compared to $436.1 million as of December 31, 2018. The decrease of $87.0 million for the six months ended June 30, 2019 included certain infrequent payments such as $5.0 million for the acquisition from an Astellas subsidiary of technical know-how related to drug conjugate linker-toxin and CD3-based bispecific antibody technology in the first quarter, a $13.7 million federal tax payment for the 2018 tax return filing in the second quarter and approximately $4.7 million related to the UCSB license agreement, also in the second quarter.

Revenue was $9.0 million for the three months ended June 30, 2019, compared to $21.3 million for the three months ended June 30, 2018. The decrease in revenue of $12.3 million for the three months ended June 30, 2019 compared to the corresponding period in 2018 was primarily due to the $21.0 million milestone payment (net of the associated sublicense fee of $4.0 million) earned in May 2018 under the CD71 Agreement with AbbVie, of which $9.9 million was recognized in the second quarter of 2018 reflecting the percentage completed-to-date of the project related to this milestone.

Research and development expenses increased $5.3 million during the three months ended June 30, 2019 compared to the corresponding period in 2018. The increase was attributable to $3.4 million in license fees and maintenance fees related to an amendment to the UCSB Licensing Agreement (which included the issuance of 150,000 shares of Company common stock valued at $1.6 million, an upfront payment of $1.0 million and an additional annual maintenance fee of $0.8 million), an increase of $0.8 million sublicense expense pertaining to the $10.0 million milestone payment earned upon the AbbVie selection of the second target in the second quarter of 2019 under the Amended and Restated Discovery Collaboration and License Agreement, an increase of $2.4 million in personnel-related expenses due to an increase in headcount, an increase of $0.5 million in clinical related expenses resulting from increased clinical trial activities and an increase of $0.7 million in the allocation of information technology and facilities related expenses resulting from an increase in headcount, partially offset by a decrease of $2.3 million in laboratory contracts and services as a result of timing of manufacturing activities.

General and administrative expenses increased by $0.4 million during the three months ended June 30, 2019 compared to the corresponding period in 2018. The increase was attributable to an increase of $1.0 million in personnel-related expenses due to an increase in headcount, an increase of $0.3 million for dues and subscriptions primarily related to software and other IT services and an increase of $0.2 million in professional service expenses, partially offset by a decrease of $0.5 million in consulting and contract services and a decrease of $0.7 million through increased expense allocation of information technology and facilities-related expenses to research and development due to an increase in research and development headcount.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 7785617. An archive of the webcast will be available on the CytomX website from August 7, 2019, until August 21, 2019.

On August 7, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that The University of New Mexico (UNM) Comprehensive Cancer Center and the New Mexico Alliance for Cancer Care will utilize Personalis’ cancer immunogenomics platform, ImmunoID NeXT, for the investigation of biomarkers of response to a novel treatment paradigm in women with ovarian cancer (Press release, Personalis, AUG 7, 2019, View Source [SID1234538335]). The basis of this trial, which evaluates the combination of Olaparib and Tremelimumab in women with recurrent BRCA-deficient ovarian cancers, is based on the work of Sarah Adams, MD, that indicated that immune priming with targeted cytotoxic therapy using a PARP-inhibitor can sensitize ovarian tumors to immune therapy and optimize patient survival. The clinical trial is being conducted at several ORIEN centers across the United States. For more information please visit clinicaltrials.gov identifier NCT02571725.

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"We are delighted to collaborate with Personalis on this study," said the principal investigator of the study, Dr. Adams, Associate Professor, Division of Gynecologic Oncology at the UNM Comprehensive Cancer Center. "Comprehensive immuno-profiling will inform on biomarkers of response for this experimental treatment in women with BRCA1 or BRCA2 germline mutated ovarian cancers, for which there aren’t standard curative measures."

Personalis ImmunoID NeXT Platform provides a comprehensive interrogation and analysis of ~20,000 genes in both DNA and RNA. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery applications, simultaneously enabling the analysis of: tumor escape mechanisms (including HLA typing and somatic mutation detection), immune repertoire profiles, neoantigen load, tumor mutational burden (TMB), microsatellite instability (MSI), oncoviruses, and immune checkpoint gene expression.

On August 7, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the second quarter ended June 30, 2019 (Press release, G1 Therapeutics, AUG 7, 2019, View Source [SID1234538364]).

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"Our most advanced investigational therapy, trilaciclib, has demonstrated significant benefits for people being treated with chemotherapy for small cell lung cancer and triple-negative breast cancer. We are pleased that the FDA has granted Breakthrough Therapy Designation based on myelopreservation data in small cell lung cancer, an important step toward making trilaciclib available to these patients. We look forward to working with the FDA during our pre-NDA meeting next month. We have also initiated parallel discussions with the FDA regarding promising data in metastatic triple-negative breast cancer, which showed improved overall survival," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "In addition, we continue to make rapid progress across our pipeline, with emerging data suggesting that all three investigational therapies – trilaciclib, lerociclib and G1T48 – have the potential to improve outcomes for women with breast cancer and be used in early stages of their disease."

Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D, added, "We will present new data on trilaciclib, lerociclib and G1T48 at the upcoming ESMO (Free ESMO Whitepaper) congress. Of note, we will report the first clinical data from approximately 25 patients in a Phase 1 trial of G1T48, our oral selective estrogen receptor degrader. Based on data from this trial, we are planning to initiate a pivotal trial in 2020 with G1T48 for the treatment of ER+, HER2- breast cancer in combination with a CDK4/6 inhibitor."

Clinical, Regulatory and Corporate Updates

Breakthrough Therapy Designation (BTD) granted for trilaciclib based on myelopreservation data in small cell lung cancer (SCLC) patients; U.S. and European regulatory filings on track for 2020: The company has received BTD from the U.S. Food and Drug Administration (FDA) based on positive myelopreservation data in small cell lung cancer patients from three randomized Phase 2 clinical trials. The BTD program is designed to expedite development and review of drugs intended for serious or life-threatening conditions. The company expects to submit marketing applications in the U.S. and Europe in 2020.

Preliminary overall survival (OS) results from randomized Phase 2 trial demonstrated women with metastatic triple-negative breast cancer (mTNBC) lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone: Myelopreservation results, objective response rate (ORR), progression-free survival (PFS) and safety data from this trial were presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) (press release here). In June 2019, the company reported updated anti-tumor efficacy results that showed women receiving trilaciclib and a chemotherapy regimen of gemcitabine/carboplatin had a statistically significant improvement in OS compared with those receiving gemcitabine/carboplatin alone (press release here). Detailed data from this trial will be presented at a medical meeting later this year.

Data on all three clinical-stage programs accepted for presentation at ESMO (Free ESMO Whitepaper) 2019 Congress: New clinical data on trilaciclib, lerociclib and G1T48 have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress, being held Sept. 27-Oct. 1. Presentations include the first clinical data on G1T48, an oral selective estrogen receptor degrader (SERD), myelopreservation and efficacy data from the Phase 2 trilaciclib + chemotherapy + Tecentriq (atezolizumab) small cell lung cancer trial, and safety and tolerability data from the Phase 1b/2a lerociclib + Tagrisso (osimertinib) non-small cell lung cancer trial. The company will host a webcast on Sunday, Sept. 29 to review the data and provide an overview of development and commercial plans across the pipeline.

Additional data on trilaciclib reported at ASCO (Free ASCO Whitepaper) and MASCC/ISOO annual meetings: The company reported additional data from trilaciclib SCLC clinical trials at both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) 2019 annual meetings. Pooled myelopreservation and patient-reported outcomes (PRO) data from all three trilaciclib SCLC trials presented at MASCC 2019 showed significant multilineage benefits across neutrophils, red blood cells and platelets, and significantly improved symptoms and function across multiple parameters over time compared to placebo.

Executive team update: In July, the company announced the appointment of Mark Avagliano as Chief Business Officer. Prior to joining G1, Mr. Avagliano was Vice President, Corporate Development at Pfizer Inc., where he was responsible for the evaluation, planning and execution of significant corporate level transactions and oversaw the Mergers and Acquisitions, Transactions and Valuations, and Out-licensing groups (press release here).

Board of Directors update: In June, current board member Garry Nicholson was named board chair, succeeding former chair Seth Rudnick, M.D. Additionally, Dr. Rudnick, Sir Andrew Witty and Fredric Eshelman, Pharm.D. were re-elected to the company’s Board of Directors.

Second Quarter 2019 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $324.9 million as of June 30, 2019, compared to $369.3 million as of December 31, 2018.

Operating Expenses: Operating expenses were $32.6 million for the second quarter of 2019, compared to $21.7 million for the second quarter of 2018. GAAP operating expenses include stock-based compensation expense of $3.7 million for the second quarter of 2019, compared to $2.1 million for the second quarter of 2018.

Research and Development Expenses: Research and development (R&D) expenses for the second quarter of 2019 were $23.5 million, compared to $18.4 million for the second quarter of 2018. The increase in R&D expense was primarily due to an increase in clinical program costs and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the second quarter of 2019 were $9.1 million, compared to $3.3 million for the second quarter of 2018. The increase in G&A expense was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities, and an increase in professional fees and other administrative costs necessary to support our operations as a public company.

Net Loss: G1 reported a net loss of $30.7 million for the second quarter of 2019, compared to $20.9 million for the second quarter of 2018.

2019 Guidance: the company expects to end the year with $260-$270 million in cash and cash equivalents.

Anticipated Milestones for 2H 2019

Present new clinical results for trilaciclib, lerociclib and G1T48 at the ESMO (Free ESMO Whitepaper) 2019 Congress, being held Sept. 27-Oct. 1. The company will host an onsite event/webcast on Sunday, Sept. 29 to review the data.

Complete meetings with the FDA and provide regulatory update for trilaciclib, including NDA filing timeline.

Present preliminary OS findings from trilaciclib mTNBC trial at a medical meeting in 2H19

Present additional data from the Phase 1b/2a clinical trial of lerociclib + Faslodex (fulvestrant) in ER+, HER2- breast cancer in 4Q19.

In 4Q19, identify dose and schedule of lerociclib and G1T48 for pivotal trials in breast cancer in 2020.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the second quarter 2019 ended June 30, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 7989125. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

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]).

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"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.